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

项目摘要/摘要 这项提议的长期目标是改善大血管阻塞患者的护理 急性缺血性中风。目前，机械血栓摘除技术可以实现血栓再通 70%的病例，医生正在迅速采用抽吸术取栓而不是支架置入术。吸气 保持与支架取回术相同的血管造影和临床结果，但更大的导管和新的 组合技术带来了更快、更便宜、更有效的“超级钻孔”装置的前景。 改进抽吸技术的方法是扩大远端留置导管的内径 (DACS)：体外研究表明，ID为0.088“的导管具有接近完美的血栓吸入率 一次通过，刺激多个超级钻孔088 DAC系统的发展。虽然人们对这一运动的热情 088DAC在介入性卒中社区中仍然非常高，最近的临床限制 报告指出了一些关键方面，这些方面可以很容易地通过新的设计功能来改进。首先，“一刀切” 对于许多患者，尤其是颅内动脉较小的女性，“ALL”入路可能并不理想。 具体地说，大多数血栓所在的大脑中动脉(MCA)具有不同的宽度。第二， 承诺用大口径导管进行“局部止血”，导管本身大到足以止血。 向前流动，如果凝块没有立即被摄入，就会解体，并在尖端必须被拉入时用软木塞住凝块 导尿管，有下游血栓的风险。第三，0.088英寸的ID对于凝块来说仍然太小 颈内动脉。最后，目前提出的大多数088DAC与8Fr访问不兼容 因此，不能在标签上使用动脉闭合装置，从而增加出血的风险。 为了应对这些挑战，我们设计了一种新颖的、双分量、可伸缩的“双DAC”系统 作为一个单元，在实现8Fr短鞘兼容性的同时，具有与其他“超级钻孔”DAC相同的ID。 内部DAC提供目标0.088英寸ID，但适合外部DAC的0.101“ID。通过减薄 两个嵌套式DAC，我们提供了其他Super Bull 088的所有性能特征和更多功能 DACS系统。我们的系统可以放置在大脑中动脉，但不是单一的厚壁0.088英寸导管，我们的系统 允许在大多数患者中同时放置两个DAC。内部DAC用于吸气，而 外部DAC保留在MCA中，以便在取回内部DAC期间持续的局部流动停止。此外， 我们的内置DAC，外径几乎比其他超级口径088 DAC小1FR，甚至可以适合狭窄的MCAS 在较小的女性身上。到目前为止，我们已经构建了原型，并展示了 领先神经血管模拟器中的双DAC系统。在本阶段1中，我们建议细化和测试 系统实现了设计冻结。如果成功，这项研究计划将提供下一代系统 对于凝块摄取，我们将通过GLP动物和其他试验推动其商业化 在我们的第二阶段实现监管许可所需的。

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.