Non-Invasive Intraoral LED Phototherapy Device for the Prevention and Treatment of Oral Mucositis

 描述(申请人提供)：这项SBIR的目标是创造一种新型的光治疗性光传输设备，将提高口腔粘膜炎(OM)的预防和治疗的护理标准。OM是癌症治疗中最常见和最重要的毒性之一。在美国，每年大约有45万名患者受到OM的影响。OM是一种极其痛苦的情况，它会破坏口腔的衬里，并与更多的治疗间隔时间、增加的100天死亡率和相当大的医疗费用增加有关。OM患者的护理标准主要是姑息性的，旨在减少疼痛、炎症和感染的风险。光疗(PT)是治疗和预防OM的一种新的、被证明有效的方法。近红外线可以增加三磷酸腺苷的生成，保护粘膜免受细胞死亡的伤害。未见使用光疗治疗OM的副作用的报道。目前使用光疗的障碍包括激光设备的成本、劳动强度、操作者之间的可变性以及不一致的光穿透。Lumitex PT正在开发一种灵活的、生物兼容的 硅胶导光板，用治疗性光照射整个口腔粘膜。关键创新 我们的光传输技术可以集成到一个接口中，在可容忍的时间内安全地将4-6J/cm2的近红外光直接传输到口腔粘膜，并可以证明符合要求。为了解决这一假设，我们创建了以下目标：1.构建和优化一种利用光导技术同时将光治疗光传递到整个口腔粘膜的装置。制造符合本提案中详细说明的输出和安全要求的设备将实现这一目标。2.在受控的临床环境中展示患者的依从性和安全性。该设备将根据预期用途的适合性和患者的安全进行评估。在第一阶段完成后，我们将成功地开发出一种能够以有效、可控的方式提供所需光剂量的光疗口罩。我们的长期目标是为所有有口腔粘膜炎风险的患者创造一种家庭设备，允许临床医生控制剂量和患者自我给药。

 DESCRIPTION (provided by applicant): The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral Mucositis (OM). OM is one of the most common and highly significant toxicities of cancer therapy. Approximately 450,000 patients are affected by OM in the United States each year. OM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaks, increased 100-day mortality and a considerable increase in healthcare costs. The standard of care for patients with OM is mainly palliative, aiming to reduce pain, inflammation, and risk of infection. A new, proven, and powerful approach for both treatment and prevention of OM is Phototherapy (PT). Near-Infrared light increases the production of ATP which protects the mucosa from cell death. No reported side effects are observed from using phototherapy for the treatment of OM. Current barriers to the use of phototherapy include the cost of laser equipment, labor intensiveness, inter-operator variability, and inconsistent light penetration. Lumitex PT is developing a flexible, biocompatible silicone light guide to irradiate the entire oral mucosa with therapeutic light. The key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfort and compliance. Our light delivery technology can be integrated into a mouthpiece that safely delivers 4-6 J/cm2 of NIR light directly to the oral mucosa in a tolerable period of time and can demonstrate compliance. To address this hypothesis we created these aims: 1. Construction and optimization of a device utilizing light guide technology to deliver phototherapeutic light to the entire oral mucosa simultaneously. Manufacturing a device that meets the output and safety requirements detailed in this proposal will complete this aim. 2. Demonstration of patient compliance and safety in a controlled clinical environment. A pilot study will be comprised of head and neck cancer patients undergoing radiation while receiving phototherapeutic treatment under conditions mimicking expected end use. The device will be evaluated based on fitness for intended use and patient safety. Upon completion of Phase I, we will successfully have developed a phototherapeutic mouthpiece capable of delivering the required light dosage in an effective, controlled manner. During Phase II we will develop a manufacturable, sterilizable, cost-effective iteration for commercialization and prove its clinical efficacy. Our long-term goal is to create a home-based device for all patients at risk for developing Oral Mucositis, allowing the clinician to control dosage and the patient to self- administer.