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 的第一阶段 STTR 申请需要 12 个月的时间，重点关注 PI 是一名血管外科医生，负责开发新型血管内静脉血栓切除装置。 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 该应用程序的主要目标是测试 基于导管的静脉血栓切除装置旨在解决现有技术中的所有差距 治疗下腔静脉（IVC）和髂静脉（iliocaval）大容量深静脉血栓（DVT） 静脉段）。 每年，超过 900,000 名美国人将患上大容量 DVT，多达 100,000 人因此死亡。 大约 50% 的患者在诊断后 2 周内出现并发症。 DVT 会产生严重的并发症，例如致命的肺栓塞 (PE)。 髂腔静脉段的容量DVT是有限的，目前可用的经皮血管内治疗 血栓切除装置有多种缺点，影响治疗效果和安全性。 术中血栓栓塞导致肺栓塞的风险增加，溶栓渗透不良导致 增加出血风险，并且无法完全清除血栓，导致未解决的 DVT。 我们设计并制作原型的经皮静脉血栓切除装置的所有最新技术差距 Hydra 导管的独特和专有功能包括可调节封装。 球囊、输液导管段，以促进溶栓剂的输送和等容输注/抽吸， 和一个内置的传单搅拌器，我们的初步研究结果表明，与目前的 FDA 相比，它具有更高的功效。 我们的多学科研究小组建议批准机械抽吸血栓切除术导管。 在离体腔静脉血流模型中测试 Hydra 导管原型在以下临床中的可行性： 相关具体目标： 目标 I：确认 Hydra 导管可调节球囊封装设计消除了栓塞 远端血栓碎片。 目标 II：证明等容抽吸可以清理静脉“治疗区”，而不会造成静脉损伤 墙壁倒塌和距离损坏。 目标 III：确定 Hydra 导管小叶搅拌器是否会增加血块破碎和抓握。 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 用于治疗大容量髂腔静脉 DVT 的原型 这些发现将使我们能够为 II 期临床试验做好准备。 通过预期的 510(k) 机制进行 FDA 监管许可所需的商业化研究 基于专为机械或化学血栓切除术设计的谓词设备。

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