RAPID, ROBUST AND AUTOMATED CONTINUOUS CARDIAC OUTPUT

心输出量（CO）是心脏的基本性能指标。最近的进展已经允许每1-5分钟更新一次的CO的自动热稀释测量，但是这些更新被先前的数据严重加权，因此使源自流量突然变化的信号失真、延迟和衰减。已经开发了一种热噪声降低技术，该技术允许测量CO，其独立更新频率超过每分钟一次，并允许在基线血液温度变化期间监测CO，这是干预的结果。I期体外和体内研究表明，该方法比巴克斯特Vigilance CCO仪器更准确、更精确（2倍），测量速度更快（>7倍）。在第II阶段，我们将开发一种适合于大批量生产导管的工艺。还将开发一种独立的临床微处理器控制的CCO仪器，以及用于收集、分析和数据显示的必要软件和算法。整个系统将在一系列猪实验中进行广泛测试，以测试准确性、更新速度以及在显着热噪声条件下测量流量的能力。TTI CCO能够提供独立于既往数据的频繁测量，这对于心血管血流动力学变化的不稳定患者的管理具有极大的益处。拟定商业应用：预计全球销售的许多TDCO导管（每年超过200万件）最终将被CCO导管取代。TTI CCO方法提供的快速和独立的测量以及热噪声抑制有望提高CCO的接受度，并开辟目前可用技术无法达到的其他应用和市场。连续心输出量的额外受益预计将证明CCO器械相对于传统TDCO的适度成本增加是合理的。

Cardiac output (CO) is the fundamental performance measure of the heart. Recent advances have permitted automatic thermodilution measurement of CO with updates every 1-5 minutes, but these updates are heavily weighted by prior data and thus distort, delay and attenuate the signal which derives from sudden changes in flow. A thermal noise reduction technique has been developed which allows the measurement of CO with independent updates more frequent than once a minute and permits monitoring of CO during changes in baseline blood temperature which are consequences of interventions. Phase I in vitro and in vivo studies have shown that this method is more accurate, more precise (2-fold), and bas greater measurement speed (>7 times) than the Baxter Vigilance CCO instrument. In Phase ll, we will develop a process appropriate to manufacture catheters in production volumes. A stand-alone clinical microprocessor controlled CCO instrument will also be developed, as will the necessary software and algorithms for the collection, analysis and data display. The entire system will be extensively tested in a series of porcine experiments for accuracy, update speed and the ability to measure flow under conditions of significant thermal noise. The ability of the TTI CCO to provide frequent measurements, independent of prior data, will be of great benefit in the management of unstable patients with variable cardiovascular hemodynamics. PROPOSED COMMERCIAL APPLICATION: It is anticipated that many of the TDCO catheters sold world-wide (>2 million annually) will eventually be replaced by CCO catheters. The rapid and independent measurements as well as the thermal noise rejection provided by the TTI CCO method is expected to increase the acceptance of CCO and open up other applications and markets unreachable by the currently available techniques. The added benefit of continuous cardiac output, is expected to justify the modest added cost of the CCO device over traditional TDCO.