INTELLIGENT MOUTHGUARD FOR MEASURING HEAD IMPACTS IN YOUTH ATHLETES

描述（由申请人提供）：在美国，有5300万年轻运动员参加接触性运动，每年有173，000至380万名年轻运动员遭受脑震荡，主观脑震荡识别增加了死亡，失学时间，认知能力下降，慢性创伤性脑病（CTE），抑郁症，自杀，痴呆症，阿尔茨海默病和帕金森病的风险。然而，一线护理人员缺乏一种客观的方法来识别潜在的脑震荡年轻运动员，而是依靠主观识别或自我报告。 症状由于这一重大的临床差距，年轻运动员在受伤时逃避评估，在持续未诊断的脑震荡后死亡，并可能因累积的头部撞击而损害他们的长期大脑健康。该项目的目标是通过低成本无线“智能护嘴”头部撞击剂量计的商业化，减少年轻运动员与运动有关的脑震荡和亚脑震荡撞击的发生率和后果。这一创新将最终为一线护理人员提供一种低成本、准确的工具 在戴头盔和不戴头盔的运动中，实时识别所有处于危险中的运动员，以便他们可以从比赛中移除，以进行进一步评估。从长远来看，目标是确定累积的亚震荡头部撞击与大脑健康下降风险之间的关系。第一阶段的假设是，一个准确的无线传感包可以完全嵌入到一个运动护齿套，并在安全的人体辐射暴露限度内传输头部撞击数据超过25米。第一阶段的具体目标是识别和测试符合成本、传输距离、功率预算、电池寿命、辐射、准确性和口腔内要求的现成运动传感器、电池和无线发射器的组合。 数量要求。传感器将在台式设备中进行测试，该设备将在类似脑震荡的条件下量化准确度和精密度。将对电池进行准静态测试，以确定对人体钳口挤压力的耐受性。无线数据传输距离与辐射发射将被量化。年轻运动员焦点小组将提供关于可接受的口内感测包体积的反馈。将使用定制的体外线性冲击器和拟人人头模型构建和测试无线原型。动态冲击测试将基准数据收集精度与黄金标准参考碰撞假人。低成本组件、可持续使用240分钟以上的可充电电池、至少25米的无线传输、低于FCC限制的辐射发射、小于4000 mm3的体积以及相对于参考的可接受精度的任何组合都将定义成功。在本阶段I STTR结束时，预计将定义满足特定目标成功标准的可用现成组件的几种组合的选择网格。至少有一个设计将准备进行第二阶段原型设计和临床试验测试。国内市场占毛 智能护齿器在商业化后3年内销售额约为2700万美元。国际市场将有可能增加销售。

DESCRIPTION (provided by applicant): With 53 million young athletes participating in contact sports, and between 173,000 to 3.8 million concussions endured by young athletes yearly in the US, subjective concussion identification increases risk of death, time lost from school, cognitive decline, chronic traumatic encephalopathy (CTE), depression, suicide, dementia, Alzheimer's and Parkinson's Diseases. However, frontline caregivers lack an objective way to identify potentially concussed young athletes, instead relying on subjective identification or self-reported symptoms. Because of this significant clinical gap, young athletes evade evaluation to play when injured, dying after sustaining undiagnosed concussions and possibly damaging their long-term brain health due to cumulative head impacts. The goal of this project is to reduce the incidence and consequences of sport-related concussion and sub-concussive impacts in young athletes via commercialization of a low-cost wireless "Intelligent Mouthguard" head impact dosimeter. This innovation will finally provide frontline caregivers with a low-cost, accurate tool to identify all at-risk athletes in real-time in helmeted and non-helmeted sports so they may be removed from play for further assessment. On a longer term the goal is to define the relationship between cumulative sub-concussive head impacts and risks of decline in brain health. The Phase I hypothesis is that an accurate wireless sensing package can be fully embedded into an athletic mouthguard and transmit head impact data over 25 meters within safe human radiation exposure limits. The Phase I Specific Aim is to identify and test combination(s) of off-the-shelf kinematic sensors, batteries and wireless transmitters that meet cost, transmission distance, power budget, battery life, radiation emitted, accuracy and intra-oral volume requirements. Sensors will be tested in a benchtop apparatus that will quantify accuracy and precision under concussion-like conditions. Batteries will be tested quasistatically to determine resistance to human jaw crush forces. Wireless data transmission distance versus radiation emission will be quantified. A young athlete focus group will provide feedback on acceptable intra-oral sensing package volume. A wireless prototype will be built and tested using a custom in vitro linear impactor and anthropomorphic headform. And dynamic impact tests will benchmark data collection accuracy versus gold-standard reference crash dummy. Any combination of low cost components, rechargeable battery lasting 240+ minutes, wireless transmission at least 25 meters, radiation emission below FCC limits, volume less than 4000mm3 and acceptable accuracy versus reference will define success. At the conclusion of this Phase I STTR it is anticipated that a selection grid of several combinations of available off-the-shelf components meeting Specific Aim success criteria will be defined. At least one design will be ready for Phase II prototyping and clinical trial tests. Domestic markets account for gross sales of approximately $27 million for the Intelligent Mouthguard within 3 years post- commercialization. International markets will potentially increase sales.