A Novel Catheter for Thrombolytic Drug Infusion Therapy to treat Pulmonary Embolism

一种新型溶栓药物输注治疗肺栓塞导管

• 批准号: 10547235
• 负责人: Tyler Panian
• 金额: $ 25.88万
• 依托单位: ONTOGEN MEDTECH LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547235
• 关键词: 3-Dimensional; Accounting; Address; Alteplase; Anatomic Models; Anatomy; Angiography; Animal Testing; Area; Autopsy; Blood; Blood Vessels; Blood coagulation; Caliber; Cardiogenic Shock; Cardiovascular system; Catheters; Cessation of life; Characteristics; Coagulation Process; Custom; Cytolysis; Data; Decision Making; Detection; Development; Devices; Diagnostic; Distal; Dose; Effectiveness; Ensure; Environment; Evaluation; Event; Failure; Fibrinolytic Agents; Health Care Costs; Hemorrhage; Hospital Costs; Hour; Individual; Infusion procedures; Injections; Intra-abdominal; Intravenous Bolus; Lasers; Length; Life; Liquid substance; Location; Lung; Lytic; Measurement; Measures; Medical; Modeling; Monitor; Morbidity - disease rate; Obstruction; Patients; Penetration; Peripheral; Pharmaceutical Preparations; Phase; Procedures; Provider; Pulmonary Embolism; Radial; Recipe; Right Ventricular Dysfunction; Risk; Safety; Shapes; Small Business Innovation Research Grant; System; Testing; Therapeutic; Thrombus; Time; Titrations; Torque; Translating; Trauma; Tube; United States; Venous Pressure level; Whole Blood; Withdrawal; base; design; effective therapy; fluid flow; heart damage; hemodynamics; high risk; improved; in vivo; mechanical device; minimally invasive; mortality; nitinol; novel; particle; personalized medicine; pressure; prototype; real time monitoring; risk minimization; risk of major adverse events; thrombolysis

PROJECT SUMMARY This SBIR Phase I project will focus on the development of a catheter specifically designed to reduce bleeding complications from catheter-directed thrombolysis (CDT) treatment of pulmonary embolism (PE). PE represents a leading cause of morbidity in the United States, with as many as 900,000 cases per year in the United States alone. One in four patients with PE will die suddenly without warning, and PE is the third most common cause of cardiovascular death. In addition, blood clots represent a significant burden on the economy, with healthcare costs accounting for up to $10 billion dollars annually. CDT involves placing one or more small catheters directly within the blood clot(s) in the lung(s) and infusing a thrombolytic medication (e.g. tissue plasminogen activator) to dissolve the clots over a 2-24 hour time period. It is preferred over a peripheral intravenous bolus administration of tPA in all but the highest risk patients, as a slower, more controlled infusion correlates with lower rates of life-threatening bleeding. While CDT-based thrombolytic infusions can be immensely effective, this therapy carries the risk of major adverse events including catastrophic intracranial, vascular, or intra-abdominal bleeding, and the risk of bleeding complications is proportional to the dose and duration of thrombolytic infusion. To minimize this risk, the lowest possible dose of thrombolytic should be infused over the shortest duration. This ideal endpoint would be the point when complete lysis occurs and any added thrombolytic only increases risk without any therapeutic benefit. To date, no existing CDT device allows for personalized treatment and real time monitoring of lytic effectiveness to allow for judicious titration of thrombolytic administration. Customer discovery revealed that providers desire pressure data to inform treatment decision-making. The proposed device is a CDT catheter which minimizes the dose of thrombolytic delivered. It does this by enabling hemodynamic monitoring across a thrombus for real-time detection of thrombus disruption, AND by deploying expanding nitinol lytic “baskets” for maximized thrombolytic contact area with thrombi. Its all-in-one design makes the procedure easier, safer, and less costly for the hospital. This catheter comprises two telescoping catheters wherein the outer catheter can be translated to selectively expose preformed nitinol tubing baskets for adjustable-length three-dimensional lytic infusion. The combined catheter system has four ports, each designed to address CDT milestones. The device will allow the user to (1) precisely steer the catheter and sub-select a target branch, (2) perform high pressure contrast injections to obtain diagnostic-quality angiograms, (3) infuse lytic in the full three-dimensional space of the vessel to precisely fit and fully saturate the thrombus, and (4) measure real-time, continuous, simultaneous, fluid-filled pressure proximal and distal to a thrombus to determining an appropriate therapy endpoint.

项目概要 该 SBIR 第一阶段项目将重点开发一种专门设计用于减少 导管定向溶栓（CDT）治疗肺栓塞（PE）引起的出血并发症。聚乙烯醇 是美国发病的主要原因，每年有多达 90 万例病例 唯有美国。四分之一的肺栓塞患者会在毫无征兆的情况下突然死亡，肺栓塞排名第三 心血管死亡的常见原因。此外，血栓对经济造成重大负担， 每年医疗费用高达 100 亿美元。 CDT 涉及将一根或多根小导管直接放置在肺部的血凝块内，并 输注溶栓药物（例如组织纤溶酶原激活剂）以在 2-24 小时内溶解血栓 时间段。除最高风险外，它优于外周静脉推注 tPA 对于患者来说，更慢、更受控制的输注与更低的危及生命的出血发生率相关。 虽然基于 CDT 的溶栓输注非常有效，但这种疗法存在以下风险： 主要不良事件包括灾难性颅内、血管或腹内出血，以及以下风险： 出血并发症与溶栓输注的剂量和持续时间成正比。尽量减少 对于这种风险，应在最短的时间内输注尽可能低剂量的溶栓剂。这个理想 终点是发生完全溶解并且任何添加的溶栓剂只会增加风险的点 没有任何治疗效果。迄今为止，还没有任何现有的 CDT 设备可以实现个性化治疗和 实时监测溶解效果，以便明智地调整溶栓剂量。 客户发现表明，提供者希望压力数据能够为治疗决策提供信息。 所提出的装置是 CDT 导管，可最大限度地减少所输送的溶栓剂量。它这样做 通过对血栓进行血流动力学监测，实时检测血栓破裂情况， 并通过部署扩大的镍钛合金溶解“篮子”来最大化溶栓与血栓的接触面积。它是 一体式设计使医院的手术过程更轻松、更安全、成本更低。 该导管包括两个伸缩导管，其中外导管可以平移至 选择性地暴露预制镍钛诺管篮，用于可调节长度的三维溶解输注。 组合导管系统有四个端口，每个端口都旨在实现 CDT 里程碑。该设备将 允许用户 (1) 精确操纵导管并子选择目标分支，(2) 执行高压 注射造影剂以获得诊断质量的血管造影，(3) 在完整的三维空间中注入溶解剂 血管精确贴合血栓并使其完全饱和，以及 (4) 实时、连续、同步测量， 血栓近端和远端充满液体的压力，以确定适当的治疗终点。