A Clinically Practical Laser System for Neurosurgery

描述(申请人提供)：最近自由电子激光(FEL)的研究结果表明，在某些条件下，脉冲6-7.5米辐射可以以前所未有的精度影响软组织的断裂，并且对断裂部位附近的组织损伤最小。随后的临床工作已经成功地将这种自由电子激光输出应用于几个试点的人类神经外科手术。直到最近，只有设施大小的自由电子激光才能产生所需的光脉冲特征，但这种设施与一般临床应用不兼容。Light Age，Inc.已经开发和制造了一种基于台式固态的激光光源，具有自由电子激光的输出特性。在第一阶段，该激光器安装在范德比尔特大学，在那里进行了比较组织研究。这些研究证实了新的激光光源和自由电子激光在体外组织消融方面的实质等价性。这些结果表明，这种新的激光光源应该适合于更广泛的临床应用，在各种外科手术中，自由电子激光已被证明是有效的。新的激光系统基于坚固的可调谐固态激光光源(翠绿宝石)和两级拉曼转换过程。紫翠宝石泵浦激光技术已经在世界各地的常规医疗应用中得到了应用，拉曼转换器技术已经被应用于各种科学激光系统中。在这项拟议的第二阶段工作中，将与Vanderbilt的合作者一起进行进一步的工作，以开发和展示一种适合常规神经外科应用的紧凑型医疗设备。我们的第二阶段工作以先进的激光开发和生猪手术演示为特色。由于人体研究的批准和设施已经到位，这项技术可以在以后的后续研究中迅速进入临床试验。这种激光技术能够集成到紧凑可靠的计算机控制系统中，这为将自由电子激光研究成果扩展到一般临床实践提供了一个令人兴奋的机会，为神经、视网膜和其他精密外科手术带来了良好的近期和长期好处。由于最近联邦资金的削减导致凯克设施的自由电子激光作业关闭，这项工作的重要性已经提高。现在，外科手术的临床发展的唯一途径是通过这里提出的工作。 公共卫生相关性：该项目的目的是开发一种临床激光，作为外科手术的常规工具，特别是在需要极高精度且对邻近组织的无意损伤不可接受的视神经、脑和脊柱手术中。由此产生的手术工具将是紧凑和相对便宜的，因此适合世界各地的诊所使用。由此产生的先进的外科手术程序可以很容易地以合理的成本引入大多数医院和专科诊所，并为一般人类造福。

DESCRIPTION (provided by applicant): Results of recent Free Electron Laser (FEL) studies have shown that under certain conditions pulsed 6-7 5m radiation can affect scission of soft tissues with unprecedented precision and minimal damage to tissues immediately adjacent to the scission sites. Subsequent clinical work has successfully employed this FEL output in several pilot human neurosurgeries. Until recently, only facility-sized FELs had been able to produce the required light pulse characteristics, but such facilities are incompatible with general clinical use. Light Age, Inc. has developed and built a table-top, solid state-based laser source, having the output characteristics of the FEL. In Phase I, this laser was installed at Vanderbilt University, where comparative tissue studies have been conducted. These studies have confirmed the substantial equivalence between the new laser source and the FEL, with respect to in-vitro tissue ablation. These results indicate that this new laser source should be suitable for wider clinical use in a variety of surgical procedures for which the FEL has been demonstrated to be effective. The new laser system is based upon a robust tunable solid-state laser source (alexandrite) and a two-stage Raman conversion process. The alexandrite pump laser technology is already employed in routine medical application throughout the world; and the Raman convertor technology has been employed in a variety of scientific laser systems. In this proposed Phase II effort, in conjunction with collaborators at Vanderbilt, further work will be conducted to develop and demonstrate a compact medical device suitable for routine neurosurgical application. Our Phase II work features advanced laser development and surgical demonstrations on live pigs. Because the approvals and facilities for human studies are already in place, this technology can move quickly into clinical trials in later follow-on studies. The ability of this laser technology to be integrated into a compact and reliable computer-controlled system provides an exciting opportunity to extend the fruits of the FEL research into general clinical practice, with promising near and long-term benefits for neural, retinal, and other precision surgeries. The importance of this work has been heightened due to the recent federal funding reduction that has led to the shut down of the FEL operation at the Keck facility. Now, the only way clinical development of the surgical procedures can proceed is through the work proposed here. PUBLIC HEALTH RELEVANCE: The purpose of this program is to develop a clinical laser that serves as a routine tool for surgeries, especially in the optic nerve, brain, and spine, where extreme precision is needed and where inadvertent damage to adjacent tissue is unacceptable. The resulting surgical tool will be compact and relatively inexpensive, and thus suitable for use by clinics around the world. The advanced surgical procedures that would result can be readily introduced into most hospitals and specialty clinics at reasonable cost and for general human benefit.