Isovolumetric Multimodal Venous Thrombectomy System

摘要 Caeli Vascular，LLC的这份II期STTR申请需要24个月的时间，重点是进一步 开发一种新型多模式静脉血栓切除装置。PI是血管外科医生， 生物医学研究和创业经验，并由一个高素质的团队支持， 研究人员，包括血管生物学家，神经外科医生，兽医，生物医学工程师，机械 工程师，以及营销和管理专家团队。本申请的主要目的是 在成功的I期可行性研究的基础上，进一步开发Hydra导管血栓切除系统 解决目前治疗大容量深静脉血栓的最新技术水平中的所有差距的技术 血栓（DVT）。 每年，超过90万美国人将发展为大容量DVT，其中多达10万人将 在诊断后2周内死于并发症。大容量DVT的治疗选择包括 有限的且目前可用的经皮血管内血栓切除装置具有各种缺点 影响治疗效果和安全性。主要差距包括术中血栓风险增加 栓塞导致肺栓塞（PE），化学溶栓药物的全身泄漏导致 出血风险增加，静脉壁和瓣膜创伤导致慢性损伤的风险增加， 完全清除血栓，导致DVT未消退。为了解决现有技术中的所有差距， 经皮静脉血栓切除装置，我们设计和原型的Hydra导管血栓切除术 系统该设备的独特和专有功能包括可调节的包囊球囊， 导管段，以促进化学溶栓剂的局部和明智的输送，轨道安装的小叶 不与静脉壁接合的搅拌器，以及用于等容抽吸和输注的机制，以促进 从静脉治疗区冲洗血栓碎片和血栓溶解剂。I期研究 证明了该器械预防远端微栓塞、预防静脉壁塌陷和 过度膨胀，并实现在离体流动系统中有效去除管腔血栓。在第二阶段 研究，我们的团队将进一步开发该设备的关键组件，并评估该技术的效率 体外和体内研究，具体目标如下： 目标1：开发和测试新一代Hydra泵，以促进等容抽吸和输注 通过体外流动系统中的Hydra导管血栓切除系统。 目的2：评价Hydra导管血栓切除系统在经确认的研究中的有效性和初步安全性 活体猪腔静脉DVT模型 通过完成这些拟议目标，我们将能够达到设计规格和良好的 FDA 510（k）器械申请提交所需的实验室规范（GLP）动物研究。

ABSTRACT This Phase II STTR application from Caeli Vascular, LLC entails a 24-month period focused on further development of a novel multi-modal venous thrombectomy device. The PI is a vascular surgeon with biomedical research and entrepreneurship experience, and is supported by a team of highly qualified investigators, including a vascular biologist, neurosurgeon, veterinarian, biomedical engineer, mechanical engineer, and a team of marketing and management experts. The primary objective of this application is to build on successful Phase I feasibility studies, and further develop the Hydra Catheter Thrombectomy System technology to address all current gaps in the state of the art for the treatment of large-volume deep venous thrombus (DVT). Each year, more than 900,000 Americans will develop a large-volume DVT, and up to 100,000 of these will die as a result of a complication within 2 weeks of diagnosis. Treatment options of large-volume DVT are limited, and currently available percutaneous endovascular thrombectomy devices have various shortcomings that impact treatment efficacy and safety. Major gaps include increased risk of intra-procedural thrombus embolization leading to a pulmonary embolus (PE), systemic leak of chemical thrombolytic medication leading to increased risk of bleeding, risk of vein wall and valve trauma leading to chronic impairments, and inability to completely remove thrombus leading to unresolved DVT. To address all the gaps in the state of the art of percutaneous venous thrombectomy devices we designed and prototyped the Hydra Catheter Thrombectomy System. Unique and proprietary features of the device include adjustable ecapsulation balloons, an infusion catheter segment to facilitate localized and judicious delivery of chemical thrombolytics, a rail-mounted leaflet agitator that does not engage the vein wall, and mechanism for isovolumetric suction and infusion to facilitate flushing of thrombus fragments and thrombolytics from the venous treatment zone. Phase I studies demonstrated the feasibility of the device to prevent distal microembolization, prevent vein wall collapse and over-distension, and achieve effective removal of luminal thrombus in an ex vivo flow system. In this Phase II study, our team will further develop key component of the device and evaluate the efficiency of the technology ex vivo and in vivo with the following specific aims: Aim 1: Develop and test a newer generation Hydra Pump to facilitate isovolumetric suction and infusion through the Hydra Catheter Thrombectomy System in an ex vivo flow system. Aim 2: Evaluate Hydra Catheter Thrombectomy System efficacy and preliminary safety in a validated in vivo porcine vena cava DVT model By completing these proposed aims we will be able to achieve the design specifications and Good Laboratory Practice (GLP) animal studies that are required for FDA 510(k) device application submission.