Multi-Modal Venus Clot Removal Device

多模式维纳斯凝块去除装置

• 批准号: 10009791
• 负责人: Mohamed A. Zayed
• 金额: $ 19.41万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009791
• 关键词: Abdomen; Acute; Address; Affect; Age; American; Anticoagulation; Biomedical Engineering; Biomedical Research; Blood Vessels; Blood coagulation; Boston; Caliber; Catheters; Cessation of life; Chemicals; Clinical Trials; Coagulation Process; Collaborations; Complication; Data; Deep Vein Thrombosis; Development; Device Designs; Device Removal; Devices; Diagnosis; Distal; Elements; Embolism; Engineering; Ensure; Entrepreneurship; Excision; FDA approved; Flushing; Future; Goals; Health; Hemorrhage; Hospitals; Human; Iliac Vein; Incidence; Individual; Inferior vena cava structure; Infusion procedures; International; Knowledge; Lung; Marketing; Mechanics; Medical Device; Modeling; Molds; Morbidity - disease rate; Neurosurgeon; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Pelvis; Penetration; Phase; Plastics; Population; Preparation; Procedures; Proteins; Public Health; Research Personnel; Risk; Safety; Small Business Technology Transfer Research; Smooth Muscle; Source; Suction; Surgeon; System; Techniques; Testing; Therapeutic; Therapeutic Embolization; Thrombectomy; Thrombus; Treatment Efficacy; Universities; Vacuum; Veins; Vena caval structure; Venous; Venous system; Venus; Veterinarians; Washington; base; clinically relevant; clinically significant; commercial application; commercialization; comparative efficacy; design; effective therapy; experience; grasp; improved; in vivo; individualized medicine; innovation; medical schools; minimally invasive; multidisciplinary; multimodality; novel; pressure; prevent; procedure cost; prototype; simulation; standard of care; synergism; thrombolysis

ABSTRACT This Phase I STTR application from Caeli Vascular, LLC entails a 12-month period focused on the development of a novel endovascular 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 marketing and management expert. The primary objective of this application is to test a catheter-based venous thrombectomy device designed to address all current gaps in the state of the art for the treatment of large volume deep venous thrombus (DVT) in the inferior vena cava (IVC) and iliac veins (iliocaval venous segment). Each year, more than 900,000 Americans will develop a large-volume DVT. As many as 100,000 will die as a result of a complication within 2 weeks of diagnosis. Approximately 50% of patients with large-volume acute DVT will develop a severe complication such as fatal pulmonary emboli (PE). Treatment options of large volume DVT in the iliocaval venous segment are limited, and currently available percutaneous endovascular thrombectomy devices have various shortcomings that affect treatment efficacy and safety. Major gaps include increased risk of intra-procedural thrombus embolization leading to PE, poor thrombolytic penetration leading to increased bleeding risk, 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. Unique and proprietary features of the Hydra Catheter include adjustable ecapsulation balloons, an infusion catheter segment to facilitate delivery of thrombolytics and isovolumetric infusion/suction, and a built-in leaflet agitator. Our preliminary findings demonstrated high efficacy compared to current FDA- approved mechanical suction thrombectomy catheters. Our multi-disciplinary team of investigators proposes to test feasibility of the Hydra Catheter prototype in an ex vivo vena cava flow model in the following clinically- relevant specific aims: Aim I: Confirm that Hydra catheter adjustable balloon encapsulation design eliminates embolization of distal thrombus fragments. Aim II: Demonstrate that isovolumetric suction can clear a venous ‘treatment zone’ without risk of venous wall collapse and distension damage. Aim III: Determine whether Hydra Catheter leaflet agitator increases blood clot fragmentation and grasping. By completing these proposed aims we will establish the mechanical feasibility of the novel Hydra catheter prototype for the treatment of large-volume iliocaval DVT. These findings will allow us to prepare Phase II pre- commercialization studies necessary for FDA-regulatory clearance through an anticipated 510(k) mechanism based on predicate devices designed for either mechanical or chemical thrombectomy.

抽象的 CAELI Vascular，LLC的I阶段I STTR应用程序需要一个12个月的时期 开发新型血管内静脉血栓切除术。 PI是一位血管外科医生 生物医学研究和企业家精神经验，并得到一支高素质的团队的支持 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，市场和管理专家。该应用程序的主要目的是测试 基于导管的静脉血栓切除术设备旨在解决最新技术的所有差距 下腔静脉（IVC）和伊利亚西亚（Iliocaval 静脉片段）。 每年，超过90万美国人将开发一批大型DVT。多达100,000将死于 诊断后2周内发生并发症的结果。大约50％的大剂量急性患者 DVT将产生严重的并发症，例如致命的肺栓塞（PE）。大型治疗选择 Iliocaval静脉片段中的卷DVT有限，目前可用于经皮内血管 血栓切除装置具有影响治疗效率和安全性的各种缺点。主要差距包括 增加心理内血栓栓塞的风险增加导致PE，溶栓渗透率较差。 增加了出血风险，并且无法完全去除血栓，从而导致未解决的DVT。解决 我们设计和原型的经皮静脉血栓切除术设备的所有差距 九头蛇导管。 Hydra导管的独特和专有特征包括可调节的环境 气球，一个输注导管段，可促进溶栓和等量输注/抽吸的递送 和内置的传单搅拌器。与当前的FDA-相比，我们的初步发现表明效率很高 批准的机械假设血栓切除术导管。我们的调查人员多学科团队提议 在以下临床上 - 相关特定目的： 目的I：确认Hydra导管可调气球封装设计消除了栓塞 远端血栓碎片。 AIM II：证明等元素任务可以清除一个静脉“治疗区”，而不会造成静脉 墙壁塌陷和扩张损坏。 AIM III：确定Hydra导管小叶搅拌器是否会增加血凝块碎片和抓握。 通过完成这些提出的目标，我们将建立新型Hydra导管的机械可行性 用于处理大批量iLiocaval DVT的原型。这些发现将使我们能够准备第二阶段 通过预期的510（k）机制，FDA调节清除所需的商业化研究 基于为机械或化学血栓切除术设计的预测设备。

项目成果

Quantification of the flexural rigidity of endovascular surgical devices using three-point bending tests.

使用三点弯曲测试量化血管内手术装置的弯曲刚度。

• DOI: 10.21203/rs.3.rs-3736325/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Qiu,MichaelY;Suskin,CharlesB;Becerra-Garcia,JuanJ;Roberts,SophiaH;Rucker,DeVaughnG;Zayed,MohamedA;Osbun,JoshuaW;Genin,GuyM
• 通讯作者: Genin,GuyM

Multimodal thrombectomy device for treatment of acute deep venous thrombosis.

• DOI: 10.1038/s41598-022-09001-6
• 发表时间: 2022-03-28
• 期刊: Scientific reports
• 影响因子: 4.6
• 作者: Ismail U;Rowe RA;Cashin J;Genin GM;Zayed MA
• 通讯作者: Zayed MA

Tailoring of arteriovenous graft-to-vein anastomosis angle to attenuate pathological flow fields.

• DOI: 10.1038/s41598-021-90813-3
• 发表时间: 2021-06-09
• 期刊: Scientific reports
• 影响因子: 4.6
• 作者: Williams D;Leuthardt EC;Genin GM;Zayed M
• 通讯作者: Zayed M