MAGNETICALLY SUSPENDED ROTOR BLOOD PUMP

磁悬浮转子血泵

• 批准号: 6184847
• 负责人: Don B. Olsen
• 金额: $ 99.52万
• 依托单位: UTAH ARTIFICIAL HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6184847
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomedical device power system; biomedical equipment development; blood coagulation; circulatory assist; congestive heart failure; magnetic field; medical implant science; quality of life

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.

这项工作的目标是为患有充血性心力衰竭（CHF）的患者开发一种新型心室辅助装置。 该系统与当前技术的不同之处如下： 1. 将开发完全磁悬浮叶轮以消除接触轴承 2. 将开发响应生理控制器以将系统输出与患者需求相匹配，而无需使用传感器。该系统将为 CHF 患者带来以下好处： 1. 相对于临床使用或高级开发中的其他设备，显着提高系统的可靠性和耐用性 2. 通过利用磁力轴承提供系统的独特特性，显着提高患者的生活质量基于生理需求的输出 3. 抗凝需求将减少，从而降低患者的术后费用并减少抗凝相关并发症的可能性。将实现以下具体目标： 1. 配置供人类使用的完全植入式连续流 VAD 将准备好过渡到制造 2. 该系统将包括经皮能量传输 (TET) 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为期一年的体外可靠性测试 4. 将完成至少 6 个完整系统动物植入，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审查6. 将与商业资助合作伙伴建立合作伙伴关系，以准备研究设备豁免 (IDE) 申请、制造系统并进行临床评估。连续流心室辅助装置（CFVAD）最初的目的是作为移植的桥梁，但其可靠性特性最终将有助于开发更长期的恢复和/或永久装置。 通过成功完成 D 节中描述的活动，我们可以以较低的成本为 CHF 患者提供优质的治疗选择。 开发解决可靠性和生理控制问题的新方法将显着提高循环装置的技术水平，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。