Isovolumetric Multimodal Venous Thrombectomy System

摘要 凯利血管有限责任公司的这项第二阶段STTR应用需要24个月的时间，重点是进一步 一种新型多通道静脉取栓装置的研制少年派是一名血管外科医生， 具有生物医学研究和创业经验，并由一支高素质的团队提供支持 调查人员，包括一名血管生物学家，神经外科医生，兽医，生物医学工程师，机械 工程师，以及一支营销和管理专家团队。此应用程序的主要目标是 在第一阶段成功可行性研究的基础上，进一步开发Hydra导管血栓消融术系统 解决目前治疗大容量深静脉的所有技术空白 血栓(DVT)。 每年，超过90万美国人会患上大容量的深静脉血栓，其中多达10万人会 在确诊后2周内死于并发症。大容量深静脉血栓的治疗选择如下 有限的，目前可用的经皮血管内血栓消融术设备有各种缺点 这影响了治疗的有效性和安全性。主要差距包括术中血栓风险增加 栓塞术导致肺血栓(PE)，全身化学溶栓药物渗漏 增加出血风险，静脉壁和瓣膜损伤导致慢性损伤的风险，以及无法 彻底清除导致DVT未解决的血栓。要解决当前技术水平的所有差距 我们设计的经皮静脉取栓装置--Hydra置管取栓装置 系统。该设备的独特和专有特征包括可调节的包覆气球、输液 导管节段，以便于局部和明智地输送化学溶栓剂，轨道安装的宣传单 不与静脉壁接合的搅拌器，以及便于等容抽吸和输液的机构 从静脉治疗区冲洗血栓碎片和溶栓剂。第一阶段研究 论证了该装置预防远端微栓塞术、预防静脉壁塌陷和 在体外流动系统中，可实现腔内血栓的有效清除。在此阶段II中 研究后，我们的团队将进一步开发该设备的关键部件，并评估该技术的效率 体外和体内，具体目标如下： 目标1：开发和测试新一代九头蛇泵，以促进等容抽吸和输液 通过体外流动系统中的九头蛇导管血栓消融术系统。 目的2：评价Hydra导管取栓系统的有效性和初步安全性 活体猪腔静脉DVT模型 通过完成这些拟议的目标，我们将能够达到设计规范和良好的 提交FDA 510(K)设备申请所需的实验室实践(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.