A Miniature Durable Ventricular Assist Device Technology

描述(由申请人提供)：在挽救生命和提高心脏病患者的护理质量方面，心脏辅助装置取得了非常显著的成功。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、更容易植入和移除以及更低的成本。灌流解决方案公司建议开发一种旋转式血泵技术，其转子支持系统不太可能产生血栓，其大小与目前可用的最小泵相同，但寿命长几个数量级，易于包装在不同的外壳几何结构中，以满足不同的临床应用。这种灵活性让相同的基本泵填补了许多市场细分市场。因此，临床医生不需要学习多个操作系统的特点，开发和生产成本可以分摊到更多的单位。在本阶段中，将构建和测试新设计的应用程序演示原型。泵的基本性能、耐用性和溶血特性将被记录在案。在第二阶段的研究中，将在实验室和动物植入实验中设计、制造和测试血管内(导管)和血管外(通过微创外科技术植入)泵的临床前原型。最终的结果将是有一天脑室辅助泵适用于数万名需要复苏、短期/中期支持和血泵永久辅助的患者。公共卫生相关性：心脏病是美国的主要死亡原因。这些患者中的许多人可以通过适合于在心脏骤停后快速植入以维持血流灌注的血泵来挽救，适合于在其他确定的治疗安排或生效之前进行短期/中期支持，或者适合于对虚弱的心脏进行永久性的辅助。拟议的方案将展示一种非常适合满足这些需求的泵设计方法。

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.