MAGNETICALLY SUSPENDED ROTOR BLOOD PUMP

这项工作的目的是为充血性心力衰竭（CHF）患者开发一种新的心室辅助装置。该系统将与目前的技术有以下不同：将开发一种完全磁悬浮叶轮来消除接触轴承2。将开发一种响应性生理控制器，使系统输出与患者需要相匹配，而无需使用传感器。该系统将为CHF患者提供以下好处：与临床使用或高级开发中的其他设备相比，显著提高了系统的可靠性和耐用性2。利用磁轴承的独特特性，根据生理需求提供系统输出，显著提高患者的生活质量。抗凝需求将减少，降低患者的术后成本，减少抗凝相关并发症的可能性。将达到以下具体目标：为人类使用配置的完全植入式连续流VAD将准备过渡到制造2。该系统将包括经皮能量传递（TET）系统、电池和密封的可植入控制器外壳。将在完整的预生产系统上完成为期一年的体外可靠性测试。完成至少6个完整的系统动物植入，持续时间至少为60天5。临床前准备设计历史文件和设计评审将完成。将与商业资助伙伴建立伙伴关系，准备研究器械豁免（IDE）申请，制造系统并进行临床评估。连续血流心室辅助装置（CFVAD）最初将作为移植的桥梁，但其可靠性特性最终将促进长期桥梁的发展，以恢复和/或永久装置。通过成功完成D部分所述的活动，我们可以以较低的成本为那些患有CHF的人提供更好的治疗选择。开发解决可靠性和生理控制问题的新方法将显著提高循环装置的技术水平，刺激急性循环支持装置和急慢性全人工心脏应用的新发展。

The objective of this effort is to develop a novel ventricular assist device for patients suffering from congestive heart failure (CHF). The system will differ from current technology as follows: 1. A totally magnetically suspended impeller will be developed to eliminate contact bearings 2. A responsive physiologic controller will be developed to match system output to patient need without the use of sensors. This system will provide the following benefits to CHF patients: 1. Significantly improved system reliability and durability relative to other devices in clinical use or in advanced development 2. Significantly improved patient quality of life by using the unique characteristics of the magnetic bearings to provide system output based on physiologic needs 3. Anticoagulation needs will be reduced, lowering the post-operative cost to the patient and reducing the likelihood of anticoagulation-related complications. The following specific objectives will be met: 1. A completely implantable continuous flow VAD configured for human use will be ready for transition to manufacturing 2. The system will include transcutaneous energy transfer (TET) system, batteries, and sealed implantable controller housing 3. One year in vitro reliability testing on complete preproduction systems will be completed 4. At least 6 complete system animal implants with a minimum 60 day duration will be completed 5. The pre-clinical readiness Design History File and Design Review will be completed 6. A partnership with a commercial funding partner will be in place to prepare an Investigational Device Exemption (IDE) application, manufacture the system, and perform the clinical evaluation. The continuous flow ventricular assist device (CFVAD) will be intended initially as a bridge to transplant, but the reliability characteristics will ultimately facilitate development of a longer term bridge to recovery and/or permanent device. By successfully completing the activities described in Section D we can provide a superior treatment option at a lower cost for those who suffer from CHF. Developing novel means of addressing reliability and physiologic control issues will significantly improve the state of the art in circulatory devices, stimulating new development in acute circulatory support devices and in acute and chronic total artificial heart applications.