Smart Anatomic Recognition System to Guide Emergency Intubation and Resuscitation

描述(申请人提供)：美国每年进行超过300万次紧急插管，失败率可高达50%(3-5)。成功与否在很大程度上取决于应答者在人类身上执行这一救生程序的频率。Brio Device，LLC，一家呼吸道管理医疗设备公司，正在解决将手术的成功与用户的体验脱钩的需求，他们的“智能”插管设备将解剖结构识别算法和视觉指导反馈与铰接式针头相结合。Brio的插管装置是专门为急救人员的需求而设计的，例如护理人员、急诊科人员、医院的代码小组和军事医务人员，他们通常首先到达患者身边。智能插管装置将通过在用户放置气管插管时向用户提供到达气管的正确路径的视觉指导来降低失败率。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，并确定插入管子的路径。最终，插管装置将包括LCD屏幕上的引导显示器和具有远端单轴角度控制的光学针头。为了进行这项第一阶段研究，将使用笔记本电脑或台式电脑进行图像处理和与铰接式针头配套的引导显示。长期目标是创造一种紧凑、轻便和便携的设备，以满足救护车和医院急救车的需求。这项研究的假设是，与直接喉镜相比，通过将视频引导显示与关节针头相结合，没有经验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呼吸道中的关键解剖结构。还将开发软件来确定管道应该遵循的路径，并为用户显示该信息。最后，该装置的有效性将在以医科学生为缺乏经验的用户的呼吸道模拟人体模型中得到验证。第二阶段将专注于集成引导软件，将光学针头和显示器连接到便携式设备中，并将嵌入式硬件和软件包含在针头手柄中。在第二阶段完成后，该设备将准备好进行临床试验和FDA测试。Brio将凭借其插管设备进入价值200亿美元的航空市场。最初的销售将从麻醉师开始，他们是新技术的早期采用者，以帮助困难的呼吸道。Brio将向约327,000名使用插管设备的临床医生推销其产品。美国急救插管的潜在市场价值约为9亿美元，适用于4.1万辆救护车和5800个急诊科和医院代码团队。

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.