A Clinically Practical Laser System for Neurosurgery

描述（由申请人提供）：最近的自由电子激光（FEL）研究结果表明，在某些条件下，脉冲6-7 5 m辐射可以以前所未有的精度影响软组织的切割，并对紧邻切割部位的组织造成最小损伤。随后的临床工作已经成功地在几个试点人类神经外科手术中使用了这种FEL输出。直到最近，只有设施大小的自由电子激光器已经能够产生所需的光脉冲特性，但这种设施是不兼容的一般临床使用。Light Age，Inc.已经开发并建立了一个桌面，基于固态的激光源，具有自由电子激光器的输出特性。在第一阶段，这种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。这些研究证实了新激光源和FEL在体外组织消融方面的实质等同性。这些结果表明，这种新的激光源应适用于更广泛的临床应用，在各种外科手术，自由电子激光已被证明是有效的。新的激光系统是基于一个强大的可调谐固态激光源（翠绿宝石）和两个阶段的拉曼转换过程。紫翠宝石泵浦激光技术已经在全世界的常规医疗应用中得到应用;而拉曼拉曼技术已经在各种科学激光系统中得到应用。在这项拟议的第二阶段工作中，将与范德比尔特的合作者一起开展进一步的工作，以开发和证明适合常规神经外科应用的紧凑型医疗器械。我们的第二阶段工作包括先进的激光开发和生猪手术演示。由于人类研究的批准和设施已经到位，这项技术可以在后续研究中迅速进入临床试验。将这种激光技术集成到紧凑可靠的计算机控制系统中的能力，为将FEL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，视网膜和其他精密手术带来了有希望的近期和长期利益。由于最近联邦资金减少，导致凯克设施的自由电子激光操作关闭，这项工作的重要性得到了提高。现在，外科手术的临床开发可以进行的唯一途径是通过这里提出的工作。 公共卫生相关性：该计划的目的是开发一种临床激光器，作为手术的常规工具，特别是在视神经，大脑和脊柱中，需要极高的精度，并且对相邻组织的无意损伤是不可接受的。所得到的手术工具将是紧凑的并且相对便宜，并且因此适合于由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以合理的成本很容易地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.