Development of a Miniature Right Heart Support Device

描述（由申请人提供）：充血性心力衰竭（CHF）是当今最严重的医学挑战之一。由于有500万美国人受到这种致残性疾病的破坏，CHF是医疗保险住院的主要原因。经济负担每年超过400亿美元。应对这种不祥的医疗保健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，外科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展性的。目前的替代方法包括心脏移植和血泵提供机械循环支持。虽然移植显然很重要，但移植福尔斯无法满足CHF的需求--今天在等待名单上的3,000人中只有6个捐赠的心脏--每年只有2,200个捐赠的心脏用于50,000名需要心脏置换但永远得不到捐赠心脏的人。被称为左心室辅助装置（LVAD）的当前一代心脏泵已经证明了技术在延长寿命和质量方面的卓越能力。存活率正在接近心脏移植，患者在家中过着功能性生活。然而，仍然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%）。在泵植入后，20-44%的LVAD接受者发生右心室衰竭，延长了ICU和住院时间，需要持续留置静脉内药物（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衰竭。 辅助设备（RVAD）。因此，我们建议开发世界上最小的植入式血泵REVOLUTION，作为现有LVAD的外科植入式辅助装置，为右心室衰竭提供长期治疗。所提出的循环支持装置， SBIR方案的发展基于一种新颖的微型流体动压轴承概念。因此，我们提出了一个快速通道、结合I/II期SBIR计划，其目标是：（1）在I期工作期间证明泵作为RVAD体外和短期动物实验的可行性和有效性;（2）进行慢性动物植入，以评估II期系统的长期功能、生物相容性和耐久性。到项目结束时，我们将达到“设计冻结”临床血泵系统，为临床试验和III期资金做准备。

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.