Two-for-one Stroke Thrombectomy: A novel Dual DAC to enhance navigability, lumen size, aspiration efficiency, and persistent flow arrest in mechanical thrombectomy

二合一中风血栓切除术：一种新型双 DAC，可增强机械血栓切除术中的导航性、管腔尺寸、抽吸效率和持续流动停止

• 批准号: 10698538
• 负责人: DAVID F KALLMES
• 金额: $ 49.98万
• 依托单位: PIRAEUS MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10698538
• 关键词: Acute; Address; Adoption; Anatomic Models; Anatomy; Angiography; Animal Testing; Animals; Back; Blood Vessels; Blood coagulation; Brain; Cadaver; Catheters; Cerebrovascular system; Clinical; Clinical Data; Coagulation Process; Communities; Development; Devices; Diameter; Dimensions; Distal; Embolism; Ensure; Environment; Evaluation; Excision; Freezing; Goals; Hemorrhage; In Vitro; Ingestion; Internal carotid artery structure; Ischemic Stroke; Label; Libraries; Manufacturer; Mechanics; Medical; Medical Device; Neurologic Deficit; Neurological outcome; Outcome; Pain; Patient Care; Patient-Focused Outcomes; Patients; Performance; Phase; Physicians; Physiological; Procedures; Process; Recovery; Reporting; Research; Research Personnel; Resistance; Retrieval; Risk; Site; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Specific qualifier value; Stents; Stroke; Suction; System; Techniques; Technology; Testing; Thick; Thinness; Thrombectomy; Time; Training; Vascularization; Width; Woman; aspirate; combinatorial; commercialization; comparative; design; falls; flexibility; improved; in vivo; in vivo evaluation; innovation; intracranial artery; middle cerebral artery; neurovascular; next generation; novel; porcine model; programs; prototype; replicator; response; standard of care; stroke intervention; success

PROJECT SUMMARY/ABSTRACT The long-term goal of this proposal is to improve the care of patients suffering from Large Vessel Occlusion Acute Ischemic stroke. Currently, mechanical thrombectomy techniques can achieve revascularization in over 70% of cases, and physicians are rapidly adoption aspiration thrombectomy over stent-trievers. Aspiration maintains equivalent angiographic and clinical outcomes to stent-retrieval, but larger catheters and new combinatorial techniques have given rise to promises of faster, cheaper, more effective “Super Bore” devices. The way to improve aspiration technologies is to expand the inner diameter (ID) of distal access catheters (DACs): in vitro studies have shown that catheters with ID of 0.088” have near-perfect rates of clot ingestion in a single pass, spurring development of multiple Super Bore 088 DAC systems. While the enthusiasm for the 088DACs remains extremely high among the interventional stroke community, limitations in recent clinical reports point to key aspects that could readily be improved with novel design features. First, a “one-size- fits- all” approach may not be ideal for many patients, especially women with smaller intracranial arteries. Specifically, the middle cerebral artery (MCA), where most clots reside, has variable width. Second, the promise of “localized flow arrest” with the large bore catheters, where the catheter itself is large enough to stop forward flow, falls apart if the clot is not ingested immediately and “corked” clots as the tip must be pulled into the guiding catheter, risking downstream emboli. Third, the 0.088” ID is still too small for clots that lodge in the internal carotid artery. Finally, most of the currently proposed 088DACs are incompatible with 8Fr access sheaths, and thus cannot be used on-label with arterial closure devices, increasing the risk of hemorrhage. In response to these challenges, we have designed a novel, two-component, telescoping “Dual DAC” system that, as a unit, has the same ID of other “Super Bore” DACs while achieving 8Fr short sheath compatibility. The inner DAC provides the target 0.088” ID, yet fits into the outer DAC’s 0.101”ID. By thinning the walls of the two nested DACs, we provide all of the performance features, and much more, of the other Super Bore 088 DACs. Our system can be placed in the MCA, but instead of a single, thick-walled 0.088” catheter, our system allows placement of both DACs simultaneously in most patients. The inner DAC is used for aspiration, while the outer DAC remains in the MCA for persistent local flow arrest during retrieval of the inner DAC. Further, our inner DAC, with an OD almost 1Fr smaller than other Super Bore 088 DACs, will fit even into narrow MCAs in smaller women. To date, we have constructed prototypes and demonstrated outstanding trackability of the Dual DAC system in leading neurovascular simulators. In this Phase 1 STTR we propose to refine and test the system to achieve design freeze. If successful, this research program will provide the next generation system for clot ingestion, which we will drive forward to commercialization through GLP animal and other testing required to achieve regulatory clearance in our Phase II.

项目总结/摘要 该提案的长期目标是改善大血管闭塞患者的护理 急性缺血性中风。目前，机械血栓切除术技术可以在超过10年的时间内实现血运重建。 70%的病例，医生正在迅速采用抽吸血栓切除术而不是支架取出器。抽吸 保持与支架回收等同的血管造影和临床结果，但导管更大且新 组合技术已经产生了更快、更便宜、更有效的“超级孔”装置的希望。 改进抽吸技术的方法是扩大远端通路导管的内径（ID） （DAC）：体外研究表明，ID为0.088”的导管在体内具有近乎完美的凝块摄取率。 单次通过，刺激了多个Super Bore 088 DAC系统的开发。虽然对 088 DAC在介入性卒中人群中仍然非常高， 报告指出了可以通过新颖的设计特征容易地改进的关键方面。第一，“一刀切"-- 对于许多患者，尤其是颅内动脉较小的女性患者，“All”入路可能并不理想。 具体来说，大多数凝块所在的大脑中动脉（MCA）具有可变的宽度。二是 大口径导管有望实现“局部血流停止”，导管本身足够大， 前向流，如果凝块没有立即摄入，则福尔斯会分开，并且由于必须将尖端拉入，因此会形成“软木塞”凝块 引导导管，有下游栓塞的风险。第三，0.088”的ID对于留在血管中的凝块来说仍然太小。 颈内动脉最后，目前提出的大多数088 DAC与8 Fr接入不兼容 鞘管，因此不能按标签与动脉闭合器械一起使用，增加了出血风险。 为了应对这些挑战，我们设计了一种新颖的，两个组件，伸缩“双DAC”系统 作为一个单元，具有与其他“Super Bore”DAC相同的ID，同时实现8 Fr短护套兼容性。 内部DAC提供目标0.088”ID，但适合外部DAC的0.101“ID。 两个嵌套DAC，我们提供了其他Super Bore 088的所有性能特性，甚至更多 DAC。我们的系统可以放置在MCA中，但不是单个厚壁0.088”导管，我们的系统 允许在大多数患者中同时放置两个DAC。内部DAC用于抽吸，而 外部DAC保留在MCA中，用于在收回内部DAC期间持续的局部血流停止。此外，本发明还 我们的内部DAC的OD比其他Super Bore 088 DAC小近1 Fr，甚至可以装入窄MCA 在较小的女人。到目前为止，我们已经构建了原型，并展示了出色的可跟踪性， 领先的神经血管模拟器中的双DAC系统。在第1阶段STTR中，我们建议完善和测试 系统实现设计冻结。如果成功，该研究计划将提供下一代系统 对于凝块摄入，我们将通过GLP动物和其他测试推动其商业化 在我们的第二阶段获得监管许可。