MAGNETICALLY SUSPENDED ROTOR BLOOD PUMP

磁悬浮转子血泵

• 批准号: 6054209
• 负责人: Don B. Olsen
• 金额: $ 99.84万
• 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/6054209
• 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.

这项工作的目的是为患有充血性心力衰竭（CHF）的患者开发一种新型的心室辅助装置。 该系统将与当前技术不同，如下所示：1。将开发完全磁悬挂的叶轮以消除接触轴承2。将开发出响应式生理控制器，以使系统输出与患者的需求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：1。相对于临床使用或高级发育中的其他设备的系统可靠性和持久性可显着提高，通过使用磁轴承的独特特征来根据生理需求提供系统输出3。抗抗凝需求将降低抗药性成本，以使患者的抗议成本降低和重新抗衡，从而显着改善了患者的生活质量。 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准备设计历史记录文件和设计审查将完成6.与商业融资合作伙伴的合作伙伴关系将建立准备调查设备豁免（IDE）应用程序，制造系统并执行临床评估。连续流动辅助装置（CFVAD）最初将作为移植桥，但可靠性特征最终将促进开发长期恢复和/或永久装置的长期桥梁。 通过成功完成D节中描述的活动，我们可以为患有CHF的人提供较低的成本提供出色的治疗选择。 开发解决可靠性和生理控制问题的新型方法将显着改善循环装置中的最新技术，刺激急性循环支持设备以及急性和慢性人工心脏应用中的新发展。