Development of a Minimally Invasive Partial Circulatory Support Device for Chronic Use

开发长期使用的微创部分循环支持装置

• 批准号: 10378419
• 负责人: Greg Aber
• 金额: $ 42.82万
• 依托单位: CORVION, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-11 至 2023-02-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10378419
• 关键词: Address; Affinity; Applications Grants; Assisted Circulation; Blood; Blood Circulation; Blood Tests; Cannulas; Cardiac; Cardiopulmonary Bypass; Cardiovascular system; Characteristics; Charge; Chest; Chronic; Clinical; Clinical Trials; Congestive Heart Failure; Consumption; Development; Devices; Disease; Disease remission; Early Intervention; Energy Transfer; Enrollment; Environment; Erythrocytes; Excision; Financial Hardship; Foundations; Freedom; Functional disorder; Future; Grant; Heart; Heart Atrium; Heart failure; Hemolysis; Hemostatic Agents; Hospitalization; Hour; Hybrids; Implant; In Vitro; Infection; Intellectual Property; Intervention; Laws; Lead; Left; Left Ventricular Function; Left atrial structure; Left ventricular structure; Length; Life Style; Light; Magnetism; Maintenance; Medical; Motor; Muscle; Nautilus; Operative Surgical Procedures; Outcome; Pacemakers; Patient-Focused Outcomes; Patients; Performance; Phase; Physiologic pulse; Physiological; Plasma Proteins; Platelet Activation; Positioning Attribute; Power Sources; Procedures; Pump; Quality of life; Recovery; Risk; Roentgen Rays; Running; Safety; Self-Help Devices; Skin; Small Business Innovation Research Grant; Sternotomy; Stroke; Structure of subclavian artery; Structure of subclavian vein; Surgical incisions; System; Techniques; Technology; Testing; Thick; Thoracotomy; Thrombus; Time; Treatment Failure; United States National Institutes of Health; VWF gene; Vascular Graft; Ventricular; Ventricular Function; Ventricular Remodeling; base; blood pump; design; experimental study; hemocompatibility; hemodynamics; implantable device; implantation; improved; improved functioning; in vivo; innovation; left ventricular assist device; leukocyte activation; mechanical circulatory support; minimally invasive; next generation; operation; preservation; pressure; programs; prototype; wireless

PROJECT SUMMARY The Nautilus pump is a centrifugal, totally implantable, compact, long-lasting partial circulatory assist device implanted via a minimally invasive pacemaker pocket approach to support LV function for late-stage heart failure intervention. The Nautilus pump will be connected to the systemic circulation by attachment of the pump’s inflow port to a cannula placed into the subclavian vein and positioned in the left atrium via a transseptal approach, and the outflow port to a vascular graft anastomosed to the subclavian artery. This revolutionary partial support pump is being designed to eliminate the need for invasive techniques to implant full support devices (sternotomy or thoracotomy) and eliminate the need for percutaneous cables and/or drivelines. The Nautilus pump and system will be a minimally invasive, low energy consumption system that will not impose excessive afterload on the LV, therefore maintaining pulsatility. Furthermore, it will retain native heart ventricular muscle integrity, offering the best environment for LV reconditioning. Another feature to be integrated to the pump is the next-generation transcutaneous energy transfer (TET) system, which does not require direct external coil skin contact to power the pump. This is a remarkable feature that is not present in any other competitors’ systems. Leveraging pump affinity laws, which govern centrifugal pump performance and are useful to modify pumps for new and different required duties, and the Company’s extensive intellectual property portfolio, the Nautilus pump is being designed based on our full support assist pump. It will combine permanent magnetic levitation with a low shear hydrodynamic bearing to produce an ultra-low power consumption pump that still retains the superior blood handling characteristics of full maglev technology. This highly efficient pump is then combined with implantable grade batteries and a light, external mobile wireless power source, making it a totally implanted and wirelessly powered system that does not require a percutaneous driveline, direct skin contact, or bulky external batteries. In-vivo preliminary studies using the full circulatory support pump device validated all the innovative features in this grant proposal, such as a high-efficiency pump with a low hemolysis rate. This SBIR Phase I proposed grant objectives are addressed in two specific aims that will be executed for eight months. In Aim 1, the Nautilus pump will be designed, and a prototype is fabricated to accommodate 2 – 3 L/min flows at physiologic pressures. In Aim 2, in-vitro studies, using a recirculating blood test loop, will be performed to determine red blood cell hemolysis, platelet and leukocyte activation, vWF degradation, and function, as well as overall blood hemostatic potential, compared to our full circulatory support pump and the BPX-80 Bio Pump™ (Medtronic - Minneapolis, MN, US). The conclusion of the proposed aims will demonstrate the feasibility and hemocompatibility of the Nautilus pump design. It will set the stage for a Phase II SBIR grant application where the performance, safety, and suitability of the device will be evaluated in an in-vivo setting, in addition to the development of a transeptal cannula.

项目概要 Nautilus 泵是一款离心式、完全植入式、紧凑、持久的部分循环辅助装置 通过微创起搏器口袋方法植入，以支持晚期心力衰竭的左心室功能 鹦鹉螺泵将通过泵的流入附件连接到系统循环。 通向放置在锁骨下静脉中并通过房间隔入路定位在左心房的插管的端口，以及 与锁骨下动脉吻合的血管移植物的流出端口 这种革命性的部分支持泵。 旨在消除侵入性技术植入完整支持装置（胸骨切开术或 胸廓切开术）并消除了对经皮电缆和/或传动系统的需求。 将是一个微创、低能耗的系统，不会对左心室施加过多的后负荷， 因此保持搏动此外，它将保留原生心室肌的完整性，提供 低压修复的最佳环境 集成到泵中的另一个功能是下一代。 经皮能量传输 (TET) 系统，无需直接外部线圈皮肤接触即可供电 这是任何其他竞争对手的系统所不具备的显着特征。 利用泵亲和定律，该定律控制离心泵的性能，并且可用于修改泵 新的和不同的所需职责，以及公司广泛的知识产权组合，鹦鹉螺泵 是基于我们的全支撑辅助泵而设计的，它将永磁悬浮与 低剪切流体动压轴承生产超低功耗泵，仍然保留了优越的性能 然后将这种高效泵与全磁悬浮技术的血液处理特性相结合。 植入式电池和轻型外部移动无线电源，使其成为完全植入式和 无线供电系统，不需要经皮传动系统、直接皮肤接触或笨重的外部 使用全循环支持泵装置的体内初步研究验证了所有创新。 该拨款提案中的特点，例如具有低溶血率的高效泵。 SBIR 第一阶段拟议的赠款目标分为两个具体目标，将在 8 个项目中执行 在目标 1 中，将设计 Nautilus 泵，并制造一个可容纳 2 – 3 L/min 的原型。 在目标 2 中，将使用循环血液测试环进行体外研究。 确定红细胞溶血、血小板和白细胞活化、vWF 降解和功能 与我们的全循环支持泵和 BPX-80 Bio Pump™ 相比，整体血液止血潜力 （美敦力 - 美国明尼苏达州明尼阿波利斯）。 所提出目标的结论将证明 Nautilus 泵的可行性和血液相容性 它将为第二阶段 SBIR 拨款申请奠定基础，其中性能、安全性和适用性将得到满足。 除了房间隔插管的开发之外，该设备的性能还将在体内环境中进行评估。