A Miniature Durable Ventricular Assist Device Technology

微型耐用心室辅助装置技术

• 批准号: 7668210
• 负责人: T Stephan Weber
• 金额: $ 21.01万
• 依托单位: PERFUSION SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7668210
• 关键词: Accident and Emergency department; Age; Animals; Area; Arteries; Back; Behavior; Biological; Bite; Blood; Blood flow; Caliber; Cannulations; Capital; Cardiac; Cardiac Catheterization Procedures; Cardiac Output; Cardiac Surgery procedures; Cardiology; Catheters; Cause of Death; Characteristics; Childhood; Clinical; Coagulation Process; Complex; Computer Systems Development; Cost Savings; Devices; Excision; FDA approved; Face; Femoral vein; Future; Goals; Hand; Heart; Heart Arrest; Heart Diseases; Heating; Hemolysis; Hospitals; Housing; Hybrids; Implant; Intensive Care Units; Intra-Aortic Balloon Pumping; Iron; Journals; Laboratories; Laws; Lead; Learning; Left; Life; Liquid substance; Literature; Magnetism; Marketing; Measurable; Measures; Methods; Modification; Motor; Myocardium; Operating Rooms; Operating System; Operative Surgical Procedures; Output; Partner in relationship; Patients; Performance; Perfusion; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Polymers; Positioning Attribute; Procedures; Production; Pump; Quality of Care; Radial; Recovery; Research; Residual state; Rest; Resuscitation; Right atrial structure; Route; Running; Side; Solutions; Study Section; Support System; Surface; Suspension substance; Suspensions; System; Techniques; Technology; Temperature; Testing; Time; Transplantation; United States; Venous; Ventricular; Weaning; Weight-Bearing state; analog; aortic valve; biomaterial compatibility; blood pump; clinical application; cost; design; flexibility; implantation; improved; in vivo; innovation; meetings; minimally invasive; pre-clinical research; pressure; prevent; programs; prototype; public health relevance; purge; research study; success; total artificial heart; ventricular assist device

DESCRIPTION (provided by applicant): Ventricular assist devices have had very significant success with respect to saving lives and improving the quality of care of heart disease patients. Among the improvements required for further progress in this area are increased biocompatibility, smaller size, easier implant and removal, and lower costs. Perfusion Solutions proposes to develop a rotary blood pump technology with a rotor support system less likely to develop clots, of size equal to the smallest pumps available today but with orders of magnitude longer life, which is easy to package in different housing geometries for different clinical applications. This flexibility lets the same basic pump fill many market niches. As a result, clinicians need not learn the characteristics of multiple operating systems and development and production costs can be spread over more units. In this phase I application demonstration prototypes of the new design will be built and tested. The basic performance, durability and hemolysis characteristics of the pump will be documented. In the phase II research pre-clinical prototypes of both the intravascular (catheter) and extravascular (implanted by minimally invasive surgical techniques) pumps will be designed, built and tested in the lab and with animal implant experiments. The end result will be ventricular assist pumps someday applicable to tens of thousands of patients in need of resuscitation, short/medium term support and permanent assist by blood pumps. PUBLIC HEALTH RELEVANCE: Heart disease is the leading cause of death in the United States. Many of these patients could be saved with a blood pump suitable for quick implant to maintain perfusion after cardiac arrest, for short/medium term support until other definitive treatment can be arranged or takes effect, or for permanent assist of a weak heart. The proposed program will demonstrate a pump design approach highly suitable for meeting these needs.

描述（由申请人提供）：心室辅助装置在挽救生命和提高心脏病患者的护理质量方面取得了非常显着的成功。在这一领域取得进一步进展所需的改进包括提高生物相容性、更小的尺寸、更容易的植入和移除以及更低的成本。 Perfusion Solutions 建议开发一种旋转式血泵技术，其转子支撑系统不太可能形成血栓，其尺寸与当今可用的最小泵相同，但寿命长几个数量级，易于封装在不同的外壳几何形状中，以适应不同的临床应用。这种灵活性使相同的基本泵能够填补许多市场空白。因此，临床医生无需了解多个操作系统的特性，并且开发和生产成本可以分摊到更多的单位。在第一阶段，将构建并测试新设计的应用演示原型。泵的基本性能、耐用性和溶血特性将被记录。在第二阶段研究中，血管内（导管）和血管外（通过微创手术技术植入）泵的临床前原型将在实验室和动物植入实验中进行设计、制造和测试。最终结果将是心室辅助泵有朝一日适用于数以万计需要复苏、短期/中期支持和血泵永久辅助的患者。公共卫生相关性：心脏病是美国的首要死因。其中许多患者可以通过适合快速植入的血泵来挽救，以在心脏骤停后维持灌注，以获得短期/中期支持，直到可以安排或生效其他确定的治疗，或者对虚弱的心脏进行永久辅助。拟议的计划将展示一种非常适合满足这些需求的泵设计方法。