COMPLIANCE CHAMBERS FOR ARTIFICIAL HEART IMPLANTS

描述（未编辑的申请人摘要）：胸内顺应性 ICC是解决变容积问题的最成功的方法， 一个完全可植入的搏动式人工心脏然而，现有的设计 受到气体渗透通过腔室的速率的阻碍 考虑到所有聚合物膜都受到一定程度的气体的影响， 渗透鉴于这一限制，需要经皮气体再填充 间隔频繁，最多数周。是福斯特-米勒的 这种限制可以通过使用液晶来补救的假设 聚合物（LCP），一种具有卓越机械性能和极其 低渗透性 在第一阶段计划中，福斯特-米勒证明了LCP具有 生物相容性、低渗透性、高抗疲劳性和足够的 可制造性是心室辅助设备（VAD）的理想候选者 和全人工心脏（TAH）顺应性室隔膜。拟议 第二阶段计划将展示一种新的长期性能和稳定性。 集成顺应性腔室系统。试点生产技术将在 将对使用这些技术开发和制造的组件进行评估 包括体外和体内。该项目的长期目标是 设计、开发和鉴定一个可集成的顺应室系统 与现有的和未来的血泵，使真正的植入式系统。 拟定商业应用： 拟议产品的主要市场为35，000至70，000人 据医学研究所估计， 辅助装置或全人工心脏。 当血液- 泵送系统被证明是足够安全的， 接近晚期的病人

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.