Implantable Ventricular Assist Device Directed to Long Term Right Side Support

用于长期右侧支持的植入式心室辅助装置

• 批准号: 8903080
• 负责人: WILLIAM A SMITH
• 金额: $ 22.49万
• 依托单位: PERFUSION SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-15 至 2016-12-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8903080
• 关键词: Award; Biocompatible; Blood; Blood Circulation; Caliber; Cannulas; Cannulations; Cardiovascular system; Case Study; Chest; Clinic; Clinical; Complication; Consumption; Databases; Deposition; Destinations; Development; Device or Instrument Development; Devices; Figs - dietary; Functional disorder; Future; Geometry; Goals; Heart; Heart Atrium; Heart failure; Hemoglobin; Hemolysis; Hemorrhage; Housing; Implant; Implantable Pump; Individual; Intraventricular; Laboratories; Lead; Left; Left ventricular structure; Life; Lung; Magnetism; Mechanics; Morbidity - disease rate; Motor; Muscle; New York; Output; Patients; Performance; Perfusion; Phase; Protein Structure Initiative; Pulmonary Circulation; Pulmonary Vascular Resistance; Pump; Quality of life; Reporting; Resistance; Right Ventricular Function; Right ventricular structure; Risk; Running; Side; Solutions; Speed; Staging; Support System; Survival Rate; System; Technology; Testing; Thrombus; Time; Touch sensation; Treatment Failure; Ventricular; Ventricular Function; biomaterial compatibility; design; experience; falls; flexibility; implantable device; improved; in vivo; innovation; meetings; mortality; pressure; prevent; public health relevance; seal; ventricular assist device

 DESCRIPTION (provided by applicant): LVAD use is increasing for both bridge and destination applications, but the need for right ventricular assist is apparent, even in patients selected to avoid this complication. These patients usually receive a temporary right ventricular assist device (RVAD) with a short-lived, external pump when the need becomes apparent, although the survival rate is superior with a pre-operatively planned biventricular implant. The difficulty is a paucity of good implantable systems for RVAD use. Existing implantable LVAD pumps adapted to this use bring with them significant compromises for right sided use. Perfusion Solutions has developed a passive magnetic bearing pump (the "M2F") that has been demonstrated in multiple sizes. The most extensively developed 10 mm pump is well-suited as an implanted, long-term RVAD. It is very small but produces strong flow and pressure for the pulmonary circulation. The magnetic bearing is not speed sensitive so the pump can be set to slow speed if the ventricle recovers but remain functional if there is a renewed issue with pulmonary resistance or ventricular function. The geometry is compatible with flexible implant approaches per individual case constraints. Hemolysis is extraordinarily low, perhaps due to the large, low shear magnetic bearing clearances. The pump has shown multi-year durability. The innovation of this project is the provision of the first clinical implantable RVAD which does not require major compromises to adapt to the application. The technical issues with respect to conversion of the M2F LVAD for RVAD applications are not challenging. The feasibility issue is biocompatibility as an RVAD implant. Initial feasibility will be demonstrated by two calf implants without thrombus issues. The specific aims for phase I are: (1) design of anatomically compatible and biocompatible RVAD inflow and outflow cannulae; (2) fabrication of two M2F RVAD pumps; (3) bench performance and hemolysis testing; and (4) two, 14-day in vivo RVAD implants. During Phase II, we will build 8 more systems. The database of bench testing will be increased. Longer duration implants will be performed as BiVAD's, combining the PSI system with a commercially available LVAD as appropriate at the time of the phase II proposal and award. This will demonstrate a first clinically usable product superior to anything now available or becoming available in the near future and lead into development of a fully integrated BiVAD system utilizing the clinical experience. PSI is a Cleveland Clinic spin-off company. In this project, it is teamed with the Clinic's Kaufman Heart Failure Center and Cardiovascular Dynamics Laboratory to meet the pressing need for a satisfactory RVAD system.

 描述（由申请人提供）：LVAD在桥接和目的地应用中的使用正在增加，但右心室辅助的需求是显而易见的，即使在选择避免这种并发症的患者中也是如此。这些患者通常在需要时接受临时右心室辅助装置（RVAD）和短期外部泵，尽管术前计划的双心室植入的生存率更高。困难在于缺乏用于RVAD的良好植入式系统。适用于该用途的现有植入式LVAD泵在右侧使用时会带来显著的损害。Perfusion Solutions开发了一种被动磁力轴承泵（"M2F"），已在多种尺寸中得到证明。最广泛开发的10 mm泵非常适合作为植入式长期RVAD。它非常小，但为肺循环产生强大的流量和压力。磁力轴承对速度不敏感，因此，如果心室恢复，泵可以设置为慢速，但如果肺阻力或心室功能出现新问题，泵仍保持功能。根据个体病例限制，几何结构与柔性植入物入路兼容。溶血非常低，可能是由于大，低剪切磁轴承间隙。该泵具有多年的耐用性。该项目的创新之处在于提供了第一个临床植入式RVAD，无需做出重大妥协即可适应应用。关于将M2F LVAD转换为RVAD应用的技术问题并不具有挑战性。可行性问题是作为RVAD植入物的生物相容性。将通过两个无血栓问题的小腿植入物证明初始可行性。第I阶段的具体目标是：（1）设计解剖学兼容和生物相容的RVAD流入和流出插管;（2）制造两个M2F RVAD泵;（3）实验室性能和溶血试验;（4）两个14天体内RVAD植入物。在第二阶段，我们将再建造8个系统。将增加台架试验数据库。更长时间的植入将作为BiVAD进行，在第二阶段提案和授予时酌情将PSI系统与市售LVAD结合起来。这将证明第一个临床可用产品优于目前可用或在不久的将来可用的任何产品，并利用临床经验开发完全集成的BiVAD系统。PSI是Cleveland Clinic的子公司。在这个项目中，它与诊所的考夫曼心力衰竭中心和心血管动力学实验室合作，以满足对一个令人满意的RVAD系统的迫切需要。