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.

项目总结 鹦鹉螺泵是一种离心式、完全植入型、紧凑型、长效部分循环辅助装置。 经微创心脏起搏器口袋植入支持晚期心力衰竭左心功能 干预。鹦鹉螺泵将通过连接泵的流入连接到体循环 经鼻中隔入路连接置入锁骨下静脉并位于左心房的插管； 移植血管的流出口与锁骨下动脉吻合。这款革命性的局部支撑泵 旨在消除植入完全支持装置的侵入性技术(胸骨切开或 开胸手术)，不再需要经皮电缆和/或传动系统。鹦鹉螺泵和系统 将是一种微创、低能耗的系统，不会对LV施加过多的后负载， 因此，保持了搏动。此外，它将保持天然的心室肌的完整性，提供 最适合LV修复的环境。另一个要集成到泵上的功能是下一代 经皮能量转移(TET)系统，无需外部线圈皮肤直接接触即可供电 打气筒。这是任何其他竞争对手的系统中都没有的一个显著功能。 利用泵亲和力定律，该定律控制离心泵的性能，并有助于修改泵 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 正在基于我们的完全支撑辅助泵进行设计。它将把永久磁悬浮和一种 低剪切动压轴承生产的超低功耗泵仍保持优势 全磁浮技术的血液处理特点。然后将这种高效的泵与 植入级电池和轻巧的外部移动无线电源，使其成为一款完全植入和 无线供电系统，不需要经皮传动系、直接皮肤接触或笨重的外部设备 电池。使用全循环支持泵装置的体内初步研究验证了所有创新的 这项赠款提案中的特点，例如具有低溶血率的高效率泵。 SBIR第一阶段建议的赠款目标涉及两个具体目标，将在八年内执行 月份。在目标1中，将设计鹦鹉螺泵，并制造原型，以容纳2-3 L/分钟 在生理压力下流动。在目标2中，将使用循环血液测试循环进行体外研究 测定红细胞溶血、血小板和白细胞活化、vWF降解和功能。 在总体止血潜力方面，与我们的全循环支持泵和BPX-80生物泵™相比 (美敦力-明尼阿波利斯，美国)。 拟议的AIMS的结论将证明鹦鹉螺泵的可行性和血液相容性 设计。它将为第二阶段SBIR赠款申请奠定基础，其中性能、安全性和适宜性 除了开发跨鼻中隔插管外，还将在体内环境中对该设备的性能进行评估。