Development of a Miniature Right Heart Support Device

描述（由申请人提供）：充血性心力衰竭（CHF）是当今最严重的医疗挑战之一。有500万美国人受到这种致残疾病的摧残，慢性心力衰竭是医疗保险住院的主要原因。每年的经济负担超过400亿美元。应对这一不祥的医疗威胁的综合方法包括预防和早期干预、日益复杂的药物治疗方案、手术治疗以及支架和起搏器等设备。尽管有这些可用的治疗方法，许多人的心力衰竭仍然是进行性的。目前的替代方法包括心脏移植和提供机械循环支持的血泵。虽然移植显然很重要，但却不能满足瑞士心脏基金会的需求——目前等待名单上的3000人只有6个捐赠心脏，而每年只有2200个移植心脏给5万名需要心脏替换但永远得不到捐赠心脏的人。当前一代的心脏泵，被称为左心室辅助装置（lvad），已经证明了技术在延长生命质量方面的卓越能力。存活率正在接近心脏移植，患者可以在家中过着功能正常的生活。然而，仍有许多需要改进以减少并发症，包括：出血（10-30%的接受者），感染（30-50%）和血栓栓塞（6-20%）。在植入泵后，20-44%的LVAD受者发生右心室衰竭，延长了ICU和住院时间，需要继续留置静脉药物（感染风险），并显著增加了死亡风险，但没有合适的慢性右心室

DESCRIPTION (provided by applicant): Congestive heart failure (CHF) is one of the most serious medical challenges of our day. With 5 million Americans compromised by the ravages of this disabling disease, CHF is the leading cause of Medicare hospital admissions. The economic burden exceeds $40 billion annually. A comprehensive approach to this ominous healthcare threat includes prevention and early intervention, an ever-increasingly complex medication regimen, surgical treatments, and devices such as stents and pacemakers. Despite these available therapies, heart failure for many remains progressive. Current approaches to replacement include heart transplantation and blood pumps to provide mechanical circulatory support. While clearly important, transplantation falls short of meeting the CHF need - only 6 donor hearts today for the 3,000 on the waiting list - only 2,200 a year for the 50,000 who need heart replacement but will never get a donor heart. The current generation of heart pumps, known as Left Ventricular Assist Devices (LVADs) have demonstrated the remarkable capacity of technology to extend life with quality. Survivorships are approaching that of heart transplantation and patients are living functional lives at home. However, there is still much need for improvement to reduce complications including: bleeding (10-30% of recipients), infection (30-50%), and thromboembolism (6-20%). Right ventricular failure occurs in 20-44% of LVAD recipients following the pump implant, prolonging ICU and hospital length of stay, requiring continued indwelling lines for intravenous medications (an infection risk), and significantly increasing the risk of mortality, yet there are no suitable chronic right ventricular assist devices (RVAD). Thus, we propose to develop the world's smallest implantable blood pump, the REVOLUTION, to serve as a surgically implantable adjunct to existing LVADs to provide chronic treatment of right ventricular failure. The circulatory support device proposed for development in this SBIR proposal is based on a novel miniature hydrodynamic bearing concept. Therefore, we propose a Fast Track, combined Phase I/II SBIR program with the objectives: (1) to demonstrate the feasibility and efficacy of the pump as an RVAD in vitro and short term animal experiments during the Phase I effort; (2) to conduct chronic animal implants to evaluate the long-term function, biocompatibility, and durability of the system during the Phase II. By the end of the program, we will reach a "design freeze" clinical blood pump system in preparation for clinical trial and Phase III funding.