Smart Anatomic Recognition System to Guide Emergency Intubation and Resuscitation

描述（由申请人提供）：美国每年有超过300万例急诊插管，失败率可高达50%（3-5）。成功与否在很大程度上取决于急救人员对人类进行这种救生手术的频率(6)。Brio设备有限责任公司是一家气道管理医疗设备公司，该公司正在解决将手术成功与用户体验分离的需求，他们的“智能”插管设备集成了解剖结构识别算法和视觉引导反馈，具有清晰的风格。Brio的插管装置是专门为紧急救援人员的需求而设计的，比如护理人员、急诊科人员、医院的急救小组和军事医务人员，他们通常最先到达病人身边。当用户放置气管内插管时，智能插管装置将为用户提供正确的气管路径的视觉指导，从而降低失败率。引导软件使用机器学习和计算机视觉算法来识别解剖结构并确定插入导管的路径。最终，插管装置将包括一个LCD屏幕上的引导显示器和一个具有单轴角度控制远端尖端的光学样式。为了第一阶段研究的目的，一台笔记本电脑或台式电脑将用于图像处理和伴随发音风格的引导显示。长期目标是创造一种体积小、重量轻、便于携带的设备，以适应救护车和医院急救车的需要。本研究的假设是，与直接喉镜相比，通过结合具有发音风格的视频引导显示，经验不足的用户将更成功地使用该设备正确放置气管内管。为了实现这一目标，将开发图像处理和机器学习算法来识别气道中的关键解剖结构。还将开发软件，确定管道应该遵循的路径，并为用户显示此信息。最后，该设备的有效性将在气道模拟人体模型上进行验证，医学生作为没有经验的使用者。第二阶段将专注于将引导软件、光学样式和显示器集成到一个便携式设备中，该设备包含在样式手柄内的嵌入式硬件和软件。二期完成后，该设备将准备进行临床试验和FDA测试。Brio将凭借其插管设备进入200亿美元的气道市场。最初的销售将从麻醉师开始，他们是新技术的早期采用者，以协助困难的气道。Brio将向约32.7万名使用插管设备的临床医生推销其产品。美国紧急插管的潜在市场约为9亿美元，需要41,000辆救护车和5,800个急诊科和医院急救小组。

DESCRIPTION (provided by applicant): Over 3 million emergency intubations are performed in the US every year and failure rates can be as high as 50% (3-5). Success is highly dependent on how frequently the responder performs this life-saving procedure on humans (6). Brio Device, LLC, an airway management medical device company, is addressing the need to decouple the success of the procedure from the experience of the user with their "smart" intubation device which integrates anatomic structure recognition algorithms and visual guidance feedback with an articulating stylet. Brio's intubation device is specifically designed fo the needs of emergency responders, such as paramedics, emergency department personnel, code teams in hospitals and military medics, who often arrive at the patient first. The smart intubation device will reduce failure rates by providing the user with visual instruction of the correct path to the trachea as he places the endotracheal tube. The guidance software uses machine learning and computer vision algorithms to recognize the anatomy and determine the path to insert the tube. Ultimately, the intubation device will include both a guidance display on an LCD screen and an optical stylet that has single-axis angulation control of the distal tip. For the purpose of this Phase I study, a laptop or desktop computer will be used for the image processing and the guidance display that accompanies the articulating stylet. The long-term goal is to create a device that is compact, light-weight and portable to suit the needs of ambulances and hospital crash carts. The hypothesis for this study is that by incorporating a video guidance display with an articulating stylet, inexperienced users will be more successful in correctly placing the endotracheal tube using this device compared to direct laryngoscopy. To achieve this goal, image processing and machine learning algorithms will be developed to recognize key anatomic structures in the airway. Software will also be developed determine the path the tube should follow and to display this information for the user. Finally, the efficacy of the device will be validated in airway simulation mannequins with medical students serving as the inexperienced users. Phase II will focus on integrating the guidance software, articulating optical stylet and display into a portable device with embedded hardware and software contained within the stylet handle. At completion of Phase II, the device will be ready for clinica trials and FDA testing. Brio will enter the $20 billion airway market with its intubation device. Initial sales will begin with anesthesiologists who are early adopters of new technology to assist with difficult airways. Brio will market its product to ~327,000 clinicians who use intubation devices. The U.S. addressable market for emergency intubation is ~$900M for the 41,000 ambulances and 5,800 emergency departments and hospital code teams.