COMPLIANCE CHAMBERS FOR ARTIFICIAL HEART IMPLANTS

人工心脏植入物的顺应室

• 批准号: 6607461
• 负责人: BRIAN P FARRELL
• 金额: $ 20.65万
• 依托单位: FOSTER-MILLER, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-09-15 至 2005-12-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6607461
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial interface interaction; biomaterials; biomedical equipment development; circulatory assist; clinical biomedical equipment; cow; diffusion; heart prosthesis; implant; laboratory mouse; laboratory rabbit; liquid crystal; medical implant science; polymers; tensile strength

DESCRIPTION (Unedited Applicant's Abstract): The intrathoracic compliance chamber (ICC) is the most successful solution to the variable volume problem of a totally implantable pulsatile artificial heart. However, existing designs are handicapped by the rate at which the gas permeates through the chamber diaphragm given that all polymeric membranes are subject to some degree of gas permeation. Given this limitation, percutaneous gas refills would be required at frequent intervals, measured at best in weeks. It is Foster-Miller's hypothesis that this limitation can be remedied by the use of liquid crystal polymers (LCPs), a material of remarkable mechanical performance and extremely low permeability. In the Phase I program, Foster-Miller demonstrated that LCPs have the biocompatibility, low permeability, high fatigue resistance and sufficient manufacturability to be ideal candidates for ventricular assist devices (VAD) and total artificial heart (TAH) compliance chamber diaphragms. The proposed Phase II program will demonstrate the long-term performance and stability of an integrated compliance chamber system. Pilot manufacturing techniques will be developed and components manufactured with these techniques will be evaluated both in-vitro and in-vivo. The long-term objective of this project is to design, develop, and qualify a compliance chamber system that can be integrated with existing and future blood pumps to make truly implantable systems. PROPOSED COMMERCIAL APPLICATION: The primary market for the proposed product is represented by the 35,000 to 70,000 patients per year estimated by the Institutes of Medicine to require permanent ventricular assist devices or total artificial hearts. This market could be even larger when blood- pumping systems are proven to be safe enough to use in more than the very sickest, near-terminal patients.

描述（未经编辑的申请人摘要）：胸腔内顺应性 腔室（ICC）是解决可变体积问题的最成功的解决方案 完全植入式搏动人造心脏。然而，现有的设计 气体渗透穿过腔室的速率受到限制 考虑到所有聚合物膜都会受到一定程度的气体影响，隔膜 渗透。鉴于此限制，需要经皮气体补充 经常间隔，最好以周为单位进行测量。这是福斯特-米勒的 假设可以通过使用液晶来弥补这一限制 聚合物（LCP），一种具有卓越机械性能和极其优异的材料 低渗透性。 在第一阶段计划中，Foster-Miller 证明了 LCP 具有 生物相容性、低渗透性、高抗疲劳性和充足的 可制造性成为心室辅助装置 (VAD) 的理想候选者 和全人工心脏 (TAH) 顺应室隔膜。拟议的 第二阶段计划将展示一个项目的长期性能和稳定性 集成合规室系统。中试制造技术将 将评估使用这些技术开发和制造的组件 体外和体内。该项目的长期目标是 设计、开发和鉴定可集成的合规室系统 与现有和未来的血泵一起制造真正的植入式系统。 拟议的商业应用： 拟议产品的主要市场为 35,000 至 70,000 据医学研究所估计，每年有多少患者需要永久性心室 辅助装置或全人工心脏。 当血液- 事实证明，抽水系统足够安全，不仅可以用于病情最严重的地区， 接近绝症的病人。