A cooling guide catheter for rapid heart cooling

描述(申请人提供)：美国每年有超过一百万的急性心肌梗死(AMI)。经皮冠状动脉腔内介入(PTCI)是首选的治疗方法。尽管PTCI总体上有效，但在最初心脏病发作后的一年里，30%的患者死亡。动物和临床研究表明，与单独使用PTCI相比，全身降温装置与PTCI一起使用可以减少40%-50%的心脏组织损害。这些设备有两个组件，一个是放置在下腔静脉(IVC)的冷却导管，另一个是通过导管循环冷却液的冷却控制台。导管通过冷却整个血液供应来冷却全身。由于人体的热惰性和体温调节系统，实现轻度低温(33摄氏度)需要30分钟到1小时。我们正在开发一种新的血液冷却导管(CoolGuide)，它可以为心脏提供快速、集中的冷却，同时使身体其他部分保持常温。CoolGuide的目标是1)简化降温程序，2)将器官降温时间减少到5分钟以下，3)避免全身降温并发症。通过导管循环冷却液和血液的控制台将是完整产品的一部分。导管和控制台将与PTCI一起销售。CoolGuide是一种混合型导管，结合了现有导尿管的功能和通过局部低温提供心脏保护的能力。它使用三腔聚四氟乙烯内核，为冷却液流动和血液流动提供通道。血液通过CoolGuide直接进入冠状动脉。第一阶段的原型已经证明了可行性，使用了一个大型(70公斤)的猪模型；这些原型在4-6分钟内产生了局部亚低温。在第二阶段，我们将优化CoolGuide导管和控制台，展示CoolGuide系统在大型猪体内使用时的血液相容性，并展示CoolGuide保护心脏组织的能力。这些体内数据将用于获得FDA批准进行初步人体试验。具体目标：1.设计、建造和测试用于体外和体内测试的改良CoolGuide原型，2.设计、建造和测试用于体外和体内测试的改良CoolGuide控制台，3.血液相容性测试，4.展示CoolGuide系统(控制台和导管)在大型猪身上的组织挽救效果。FDA已经并将继续为CoolGuide体内测试提供指导。相关性：与冠心病相关的总成本接近1500亿美元。改善心脏病发作患者预后的根本挑战是将缺血组织损伤降至最低。该项目寻求利用一种名为CoolGuide的聚焦器官冷却的新治疗技术来实现这一目标。美国心脏协会2005年的统计数据显示，在最初心脏病发作后的第一年，25%的男性和38%的女性死亡。最近的临床研究表明，全身亚低温(~34℃)可以挽救心脏病发作后的心脏组织。FocalCool，LLC寻求开发一种新型冷却导管，这种导管可以冷却心脏组织，而不会出现全身冷却的并发症。

DESCRIPTION (provided by applicant): Over one million acute myocardial infarctions (AMI) occur each year in the U.S. Percutaneous transluminal coronary intervention (PTCI) is the preferred treatment. Despite the overall effectiveness of PTCI, in the year following an initial heart attack, 30% of patients die. Animal and clinical studies have shown that whole-body cooling devices used together with PTCI can reduce heart-tissue damage compared to PTCI alone by 40-50%. These devices have two components, a cooling catheter that is placed in the inferior vena cava (IVC) and a cooling console that circulates coolant through the catheter. The catheter cools the whole-body by cooling the entire blood supply. As a result of the body's thermal inertia and thermoregulation system, achieving mild hypothermia (33C) takes 30 minutes to 1 hour. We are developing a new blood cooling catheter (CoolGuide) that delivers rapid focused cooling to the heart while leaving the rest of the body at normal temperature. CoolGuide aims to 1) simplify the cooling procedure, 2) reduce organ cooling time to under 5 min and 3) avoid whole-body cooling complications. A control console that circulates coolant and blood through the catheter will be part of the complete product. Catheter and console will be marketed together for use with PTCI. CoolGuide is a hybrid catheter, combining the functionality of existing guide catheters with the ability to provide cardioprotection with regional hypothermia. It uses a tri-lumen Teflon inner core, providing pathways for coolant flow and blood flow. Blood flows through the Coolguide directly into the coronary arteries. Phase I prototypes have demonstrated feasibility, using a large (70kg) pig model; these prototypes create regional mild hypothermia in 4-6 minutes. In Phase II we will optimize the Coolguide catheter and console, demonstrate hemocompatibility for the CoolGuide system during in vivo use with large swine, and demonstrate CoolGuide's ability to protect heart tissue. This in vivo data will be used to gain FDA approval for an initial human trial. Specific Aims:1.Design, build, and test refined CoolGuide prototypes for in vitro and in vivo testing, 2.Design, build, and test a refined CoolGuide console for in vitro and in vivo testing, 3.Test for hemocompatibility,4.Demonstrate the tissue salvage efficacy of the CoolGuide system (console and catheter) in large swine. The FDA has and will continue to provide guidance for CoolGuide in vivo testing. Relevance: The total cost associated with coronary disease is nearly 150 billion dollars. The fundamental challenge to improving patient outcome for heart attacks is minimizing ischemic tissue damage. This project seeks to harness a new therapeutic technology for focused organ cooling called CoolGuide to accomplish that goal. American Heart Association 2005 statistics show that in the first year following an initial heart attack, 25% of men and 38% of women die. Recent clinical studies have shown that mild whole body hypothermia (~34C) can salvage heart tissue after a heart attack. FocalCool, LLC seeks to develop a novel cooling catheter that cools heart tissue without the complications of whole-body cooling.