A novel clot containing system for improved neurothrombectomy outcomes

项目总结 机械性血栓切除术(MT)作为治疗急性缺血性卒中(AIS)的一种手段，近年来获得了新的发展。 尽管已经取得了技术进步，但目前技术的效力仍然不是最理想的，而且 多发性硬化症仍与严重并发症有关。目前的移植技术，使用支架取回器或 抽吸导管，在第一次通过后仅有不到50%的患者成功地进行了血运重建 患者与使用的技术无关。进一步的血栓并发症，发生在10%-20%的病例中， 会导致严重的后遗症。Xtract Medical正在开发一种受专利保护的附件设备，这是一种 新型血块遏制系统(CCS)，由一个可膨胀的镍钛编织管组成，在一个 通过现有的神经血管抽吸或导尿管输送的导丝。辫子被盖住了 有一层薄薄的硅胶涂层，当血液从分娩的远端延伸出来时，它会阻止血流 此外，在从患者体内取出过程中，它还可以完全封闭血栓。在 在编织器的前面，一根闭合钢丝穿过编织器中的线圈，然后连接到导丝上 从导尿管的长度一直延伸到病人的身体。这种闭合金属丝起到了陷阱的作用，因此当 缝合线是由外科医生启动的，编织带的前端就像一根钱包线。Xtract Medical‘s 解决方案将从三个基本方面提高MT程序的效率：1)它的部署导致局部 大脑中动脉(MCA)血流停止。这将增强雄心壮志的力量 与抽吸导管相结合，无论应用何种MT方法，都可以减少远端移位和 血块碎裂。2)设备在血栓近端的大脑动脉中温和扩张 更大的管腔大小使血栓被困在其中，增加了通过 第一次通过抽吸导管或支架取回器。3)通过其独特的封闭系统，该设备 在从大脑取回血块的过程中完全包含了血块，防止了血块碎片的释放 并减少栓塞症并发症。在这个SBIR一期项目中，Xtract Medical将进行Pivotal Plattop 对其辅助设备的有效性和安全性进行研究和临床前验证。第一阶段(9个月)是 可行性研究，在此期间，原型将在台式计算机上进行进一步开发和验证 猪神经血管模型(AIM-1)及其体内疗效和安全性的初步评价 模型(目标2)。在第一阶段完成后，Xtract Medical将提出第二阶段SBIR项目 建立质量体系并对关键临床前项目的设计和完成进行验证测试 GLP体内研究，这将为Xtract Medical寻求FDA批准其设备奠定基础， 以及为他们的设备的商业发布建立一条途径。

PROJECT SUMMARY Mechanical thrombectomy (MT) has recently gained impetus as a treatment for acute ischemic stroke (AIS). Although technical progress has been made, the efficacy of the current techniques remains sub-optimal and MT is still associated with significant complications. Current MT techniques, using stent retrievers or aspiration catheters, achieve successful revascularization after the first-pass only in less than 50% of the patients irrespective of the technique used. Further embolic complications, which occur in 10-20% of cases, cause significant sequelae. Xtract Medical is developing a patent-protected accessory device, which is a novel Clot Containment System (CCS) that consists of an expandable nitinol braided tube on the end of a guidewire that is delivered through existing neurovascular aspiration or guide catheters. The braid is covered with a thin silicone coating, which blocks the blood flow when it extends out of the distal end of the delivery catheter and additionally provides complete enclosure of the clot during extraction from the patient. At the front of the braid, a closure wire weaves through the loops in the braid and then connects to the guidewire that runs the length of the catheter and out of the patient. This closure wire acts as a snare so that when the closure wire is actuated by the surgeon the front end of the braid cinches like a purse string. Xtract Medical’s solution will improve the efficacy of MT procedure in three fundamental ways: 1) Its deployment leads to local blood flow arrest in the Middle Cerebral Artery (MCA). This will enhance the aspiration forces when it is combined with an aspiration catheter and, regardless of the applied MT method, reduce distal migration and fragmentation of the clot. 2) Gentle expansion of the device in the cerebral artery proximal to the clot creates a larger lumen size for the clot to be trapped into, increasing the likelihood of the entire clot removal by the aspiration catheter or stent retriever in the first pass. 3) Through its unique closure system, the device completely contains the blood clot during its retrieval from the brain, preventing the release of clot fragments and reducing embolic complications. In this SBIR Phase I project, Xtract Medical will conduct pivotal benchtop studies and pre-clinical validation of the efficacy and safety of its accessory device. Phase I (9 months) is a feasibility study during which the prototype will undergo further development and validation in a benchtop model of neurovasculature (Aim 1) as well as a preliminary evaluation of efficacy and safety in vivo in swine models (Aim 2). After completion of Phase I, Xtract Medical will propose a Phase II SBIR project for the establishment of a quality system and validation testing of the design and completion of pivotal pre-clinical GLP in vivo studies, which will lay the foundation for Xtract Medical to pursue FDA clearance of its device, as well as to establish a pathway for the commercial launch of their device.