IMPROVED DIAGNOSTIC INFRARED NERVE STIMULATOR FOR ENT NERVE MONITORING

改进的用于耳鼻喉神经监测的诊断性红外神经刺激器

• 批准号: 7477628
• 负责人: Dawn Meekhof
• 金额: $ 12.73万
• 依托单位: LOCKHEED MARTIN ACULIGHT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7477628
• 关键词: Acoustic Nerve; Animal Experiments; Animal Model; Auditory; Body part; Clinical; Clinical Protocols; Clinical Trials; Collimator; Coupled; Cranial Nerves; Development; Devices; Diagnostic; Ear; Electric Stimulation; Electrodes; Excision; Face; Facial nerve structure; Facial paralysis; Fascicle; Fiber; Fright; Future; Gerbils; Grant; Hand; Harvest; Head and Neck Surgery; Head and neck structure; Histology; Incidence; Individual; Infrared Rays; Injury; Invasive; Larynx; Lasers; Lead; Length; Light; Localized; Location; Malignant neoplasm of thyroid; Measurement; Mechanics; Methods; Microscope; Modeling; Modification; Monitor; Morbidity - disease rate; Muscle; Neck; Nerve; Nerve Tissue; Nose; Operative Surgical Procedures; Optics; Outcome; Paralysed; Parotid Gland; Patient Isolation; Patients; Performance; Pharyngeal structure; Phase; Physiologic pulse; Procedures; Public Health; Pulse taking; Radiation; Rattus; Recurrence; Recurrent Laryngeal Nerve; Research; Resolution; Safety; Scanning; Shapes; Skin; Squamous cell carcinoma; Stimulus; Surgeon; System; Techniques; Testing; Thyroid Gland; Thyroid carcinoma; Tissues; Touch sensation; Tumor Tissue; United States National Institutes of Health; Universities; Work; base; cost; design; improved; irradiation; monitoring device; neural stimulation; prevent; prototype; relating to nervous system; research study; response; sciatic nerve; size; tool; tumor

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.

描述(申请人提供)：医源性神经损伤是肿瘤切除手术对身体各部位最不利的后遗症之一。许多神经监测技术已经被开发出来，以降低损伤的发生率，最明显的是电刺激。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然没有得到充分发挥。在这项工作中，我们将开发一种基于红外辐射的神经刺激器，在提供精细的空间分辨率和扫描能力的同时，将手术中的神经损伤降至最低。我们将建造并测试一种小型手持神经刺激器，具有优化的参数和精细的控制，用于面部外科的临床应用。电流可以通过所有的躯体组织传播，在目前的神经监测器中，这会模糊组织中神经的位置和连续性，并阻止对个别神经束的刺激。这些刺激器还需要与神经接触，这可能会导致损伤，并需要反复接触组织才能搜索某个区域。在面部外科中，神经损伤的发生率高达72%，其中永久性部分或完全瘫痪的发生率高达5.6%。面神经损伤可能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经被证明可以克服这些困难。Wells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研究型红外神经刺激仪的测试表明，空间选择性非常精确，约为0.2毫米。这项工作将把研究中的红外神经刺激器改造成更小的手持版本，用于面部外科。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，我们将两个红外神经刺激器Aculight Capella R-1850和新的手持系统与电神经刺激器进行比较。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，并确定耳鼻咽喉外科手术的最佳配置。我们设想第二阶段的工作将开发一种临床红外神经刺激器原型，用于未来的临床试验。公共卫生相关性我们的目标是通过改进术中对面神经的识别和监测来减少面部手术中的神经损伤。这项工作将集中在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限制。