IMPROVED DIAGNOSTIC INFRARED NERVE STIMULATOR FOR ENT NERVE MONITORING

描述（申请人提供）：医源性神经损伤是肿瘤切除术后全身最严重的后遗症之一。许多神经监测技术已经发展到降低损伤的发生率，最显著的是电刺激。然而，由于电刺激器固有的几个关键限制，精确神经监测的临床潜力仍未实现。在这项工作中，我们将开发一种基于红外辐射能力的神经刺激器，以提供良好的空间分辨率和扫描能力，同时最大限度地减少手术过程中的神经损伤。我们将建立和测试一个小型的手持式神经刺激器，优化参数和精细控制，用于面部手术的临床应用。电流可以通过所有体细胞组织传播，在目前的神经监测器中，这模糊了神经在组织中的位置和连续性，并防止了对单个神经束的刺激。这些刺激器还需要与神经接触，这可能导致损伤，并且需要反复接触组织来搜索一个区域。在面部外科手术中，神经损伤的发生率高达72%，永久性部分或完全瘫痪的发生率高达5.6%。面神经损伤会产生毁灭性的影响，因此目前的患者结果是不可接受的。最近，使用脉冲红外辐射的神经刺激已被证明可以克服这些困难。威尔斯和他的同事已经证明，用脉冲近红外激光可以安全地刺激大鼠的坐骨神经。在范德比尔特大学和西北大学对Aculight Capella R- 1850研究红外神经刺激器的测试显示出非常精确的空间选择性，约为0.2毫米。这项工作将使研究红外神经刺激器变成一个更小的手持版本，用于面部手术。为了确定最佳的性能参数，如功率，光束准直，选择性，尺寸，成本，我们将比较两种红外神经刺激器，Aculight Capella R- 1850和新的手持系统与电神经刺激器。我们将确定安全性和有效性，证明这些激光可用于通过组织层定位神经，并确定哪种配置最适合耳鼻喉外科手术。我们设想第二阶段的努力将开发临床红外神经刺激器原型，用于未来的临床试验。我们的目标是通过改善术中面神经的识别和监测来减少面部手术中的神经损伤。这项工作将集中于开发一种红外激光神经刺激器，以克服电神经刺激器的几个关键局限性。

DESCRIPTION (provided by applicant): Iatrogenic nerve damage is one of the most adverse sequalae of tumor resection surgery in all parts of the body. Many neuromonitoring techniques have been developed to lower the incidence of damage, most notably electrostimulation. However, the clinical potential of precise neuromonitoring remains unfulfilled, due to several key limitations intrinsic to electrostimulators. In this work, we will develop a neurostimulator based on the demonstrated ability of infrared radiation to provide fine spatial resolution and scanning ability, while minimizing nerve damage during surgery. We will build and test a small, handheld neurostimulator with optimized parameters and fine control for clinical use in facial surgery. Electrical current can spread through all somatic tissue, and in present neuromonitors this obscures the location and continuity of nerves in the tissue and prevents stimulation of individual nerve fascicles. These stimulators also require contact with the nerve, which can lead to damage, and repetitive contacting of tissue to search a region. In facial surgery, the incidence of damage to nerves is as high as 72%, with an incidence of up to 5.6% for permanent partial or total paralysis. Facial nerve damage can have devastating effects and therefore the current patient outcome is unacceptable. Recently, neurostimulation using pulsed infrared radiation has been demonstrated to overcome these difficulties. Wells and coworkers have shown that the rat sciatic nerve can be safely stimulated with a pulsed near- infrared laser. Tests at Vanderbilt and Northwestern Universities of the Aculight Capella R- 1850 research infrared nerve stimulator have demonstrated very precise spatial selectivity, around 0.2 mm. This work will adapt the research infrared nerve stimulator into a smaller, handheld version for use in facial surgery. To determine the optimal performance parameters, such as power, beam collimation, selectivity, size, cost, we will compare two infrared neural stimulators, the Aculight Capella R- 1850 and the new handheld system to an electrical neural stimulator. We will determine safety and efficacy, demonstrate that these lasers can be used to localize the nerve through tissue layers, and determine which configuration is optimal for ENT surgical procedures. We envision Phase II efforts will develop a clinical infrared nerve stimulator prototype for future clinical trials. PUBLIC HEALTH RELEVANCE Our objective is to reduce nerve damage during facial surgery by improving intraoperative identification and monitoring of facial nerves. This work will focus on developing an infrared laser nerve stimulator to overcome several key limitations of electrical nerve stimulators.