Isovolumetric Multimodal Venous Thrombectomy System

等容多模式静脉取栓系统

• 批准号: 10458775
• 负责人: Stacey Liekweg
• 金额: $ 96.95万
• 依托单位: CAELI VASCULAR, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10458775
• 关键词: Address; Agitation; American; Animals; Anticoagulation; Balloon Occlusion; Biomedical Engineering; Biomedical Research; Blood Vessels; Blood coagulation; Caliber; Catheters; Cessation of life; Chemicals; Chronic; Clinical; Clinical Trials; Coagulation Process; Collaborations; Complication; Deep Vein Thrombosis; Development; Device Designs; Devices; Diagnosis; Distal; Elements; Embolism; Engineering; Entrepreneurship; Excision; Family suidae; Feasibility Studies; Flushing; Freezing; Generations; Goals; Health; Healthcare Systems; Hemorrhage; Hospitals; Impairment; Incidence; Individual; Infusion Pumps; Infusion procedures; International; Knowledge; Lead; Letters; Liquid substance; Lung; Marketing; Mechanics; Medical Device; Methods; Modality; Modeling; Morbidity - disease rate; Neurosurgeon; Outcome; Patients; Perioperative; Pharmaceutical Preparations; Phase; Procedures; Public Health; Pump; Quality of life; Reporting; Research Personnel; Residual state; Risk; Safety; Savings; Small Business Technology Transfer Research; Suction; Surgeon; System; Techniques; Technology; Testing; Therapeutic; Therapeutic Embolization; Thrombectomy; Thrombosis; Thrombus; Trauma; Treatment Cost; Treatment Efficacy; United States Food and Drug Administration; Universities; Vacuum; Veins; Vena Cava Occlusion; Vena caval structure; Venous; Veterinarians; Washington; commercial application; comparative; cost effective; design; endovascular thrombectomy; experience; good laboratory practice; improved; in vivo; in vivo evaluation; innovation; interest; medical schools; mortality; mortality risk; multimodality; novel; phase 1 study; phase 2 study; pressure; prevent; procedure cost; prototype; restoration; synergism; technological innovation; thrombolysis

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.

抽象的 Caeli Vascular, LLC 的第二阶段 STTR 申请需要 24 个月的时间，重点关注进一步 开发新型多模式静脉血栓切除装置。 PI 是一名血管外科医生 生物医学研究和创业经验，并有高素质团队支持 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 工程师，以及营销和管理专家团队。该应用程序的主要目标是 以成功的一期可行性研究为基础，进一步开发 Hydra 导管血栓切除系统 技术可解决目前治疗大容量深静脉的所有现有技术差距 血栓（DVT）。 每年，超过 900,000 名美国人将出现大量 DVT，其中多达 100,000 名美国人将患上深静脉血栓 (DVT)。 诊断后 2 周内因并发症死亡。大容量 DVT 的治疗选择是 有限，目前可用的经皮血管内取栓装置存在各种缺点 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、静脉壁和瓣膜损伤导致慢性损伤的风险以及无法 彻底清除导致未解决的 DVT 的血栓。解决现有技术中的所有差距 我们设计并制作了 Hydra 导管血栓切除术原型的经皮静脉血栓切除术设备 系统。该设备的独特和专有功能包括可调节的封装球囊、输液 导管段，以促进化学溶栓剂的局部和明智的输送，轨道安装的传单 不接触静脉壁的搅拌器，以及等容抽吸和输注机制，以促进 从静脉治疗区冲洗血栓碎片和溶栓剂。第一阶段研究 证明了该装置防止远端微栓塞、防止静脉壁塌陷和 过度扩张，并在离体流动系统中实现管腔血栓的有效清除。在本次第二阶段 研究中，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 离体和体内的具体目标如下： 目标 1：开发并测试新一代 Hydra 泵，以促进等容抽吸和输注 通过离体流动系统中的 Hydra 导管血栓切除系统。 目标 2：评估 Hydra 导管血栓切除系统的有效性和初步安全性 活体猪腔静脉DVT模型 通过完成这些提出的目标，我们将能够实现设计规范和良好的目标 提交 FDA 510(k) 设备申请所需的实验室实践 (GLP) 动物研究。