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.

项目摘要 该SBIR第一阶段项目将重点开发一种专门设计用于减少 肺栓塞（PE）导管溶栓（CDT）治疗的出血并发症。PE 是美国发病的主要原因，在美国每年有多达900，000例 只有美国。四分之一的PE患者会在没有警告的情况下突然死亡，PE是第三大 心血管死亡的常见原因。此外，血凝块是经济上的重大负担， 每年的医疗费用高达100亿美元。 CDT涉及将一个或多个小导管直接放置在肺部的血栓内， 输注血栓溶解药物（例如组织纤溶酶原激活剂）以在2-24小时内溶解凝块 时间段在除最高风险外的所有患者中，首选tPA外周静脉推注给药 患者，因为更慢，更受控的输注与危及生命的出血率较低相关。 虽然基于CDT的溶栓输注可能非常有效，但这种疗法存在以下风险： 主要不良事件，包括灾难性颅内、血管或腹腔内出血，以及 出血并发症与溶栓输注的剂量和持续时间成正比。以最小化 对于这种风险，应在最短时间内输注尽可能低剂量的溶栓药物。这个理想 终点将是完全溶解发生的时间点，任何增加的溶栓只会增加风险 没有任何治疗效果。迄今为止，没有现有的CDT设备允许个性化治疗， 真实的实时监测溶解效果以允许明智地滴定溶栓给药。 客户发现表明，供应商希望压力数据为治疗决策提供信息。 申报器械是一种CDT导管，可最大限度地减少输送的溶栓剂量。它这样做 通过使能跨血栓的血液动力学监测以实时检测血栓破裂， 以及通过展开扩张的镍钛合金溶解“篮”，以最大化与血栓的溶栓接触面积。其 一体化设计使手术更容易、更安全，并且降低了医院的成本。 该导管包括两个伸缩导管，其中外导管可以平移以 选择性地暴露预成型的镍钛诺管篮，用于可调节长度的三维溶菌输注。 组合导管系统有四个端口，每个端口都设计用于解决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 造影剂注射以获得诊断质量的血管造影片，（3）在血管的整个三维空间中注入溶解剂， 血管以精确地配合血栓并使血栓完全饱和，以及（4）实时、连续、同时 血栓近端和远端的流体填充压力，以确定适当的治疗终点。