MAGNETICALLY SUSPENDED ROTOR BLOOD PUMP

这项工作的目的是开发一种新型的心室辅助装置，用于充血性心力衰竭（CHF）患者。 该系统将与当前技术的不同之处如下：1.将开发一种完全磁悬浮的叶轮，以消除接触轴承2。将开发响应生理控制器，以在不使用传感器的情况下将系统输出与患者需求相匹配。该系统将为CHF患者提供以下益处：1.相对于临床使用或高级开发中的其他器械，系统可靠性和耐用性显著提高2。通过使用磁轴承的独特特性，根据生理需求提供系统输出，显著改善了患者的生活质量3。抗凝需求将减少，降低患者的术后成本，并降低抗凝相关并发症的可能性。将实现以下具体目标：1.配置用于人体的完全植入式连续流VAD将准备过渡到生产2。该系统将包括经皮能量传输（泰特）系统、电池和密封的植入式控制器外壳3。将完成完整预生产系统的一年体外可靠性测试4。将完成至少6个完整的系统动物植入，持续时间至少为60天5。将完成临床前准备设计历史文件和设计评审6。将与商业资助合作伙伴建立合作关系，以准备试验用器械豁免（IDE）申请、制造系统并进行临床评价。连续流心室辅助装置（CFVAD）最初预期作为移植的桥梁，但其可靠性特征最终将促进开发恢复和/或永久性装置的长期桥梁。 通过成功完成D节中描述的活动，我们可以为CHF患者提供一种成本较低的上级治疗选择。 开发解决可靠性和生理控制问题的新方法将显著改善循环装置的最新技术水平，刺激急性循环支持装置以及急性和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.