便携电子可视喉镜的研究与设计

发布时间：2018-04-22 03:29

本文选题：气管插管术 + 喉镜　；参考：《南方医科大学》2017年硕士论文

【摘要】：紧急气管插管是急诊科抢救患者中应用最多的措施之一,其对挽救急重症患者生命、降低死亡率起着重大作用。但若碰到困难气道,即便是经过正规训练的麻醉医师也有可能出现气管插管多次不能完成的情况,因困难气道气管插管失败所致的死亡率也是居高不下,而对于困难气道的处理,目前已上市的设备存在一定的局限性,如直接喉镜不能用于张口困难病例;叶片式可视喉镜不能用于颈强直患者;而纤维支气管镜价格昂贵、维修困难、不易上手。为提高困难气道的插管成功率,本文研究设计出一种带LED冷光源、微型化前置摄像头、软镜插入部,可同步观察和录制视频、可自动调节白平衡,防进液、耐清洁消毒的便携电子可视喉镜。在施行气管插管术时,尤其是困难气道的处理中,可以清楚地显示声门及口咽部位的腔内图像,引导一次性气管插管通过口咽部、喉口、会厌、声门,最终到达气管,可提高气管插管的成功率,降低气道损伤。该装置成像效果好、操作简便,价格适宜的特点具有显著的临床意义。本文设计的便携电子可视化喉镜,电子系统的关键件采用美国TI品牌的TMS320DM368视频处理器,其高频率(432MHz)和集成型外设的特点既保证了系统性能又可缩小电路板尺寸,减轻了产品重量;摄像头模组采用美国OMNIVISION公司的OV6920型CMOS感光芯片,宽度仅有1/18英寸,其尺寸小、功耗低、成像效果清晰的特点非常适合本设计;机械结构部分采用与目前的电子软镜一致的设计,先端头集成了摄像头模组及LED灯,弯曲部采用“蛇骨”(Bending Section)设计实现180°弯曲,插入部为空心软管,表面涂有多层的聚氨酯,柔软且耐用;显示器与手柄的接口采用创新性的卡式旋转紧接插口,两者便于分离,手柄以下部分可单独浸泡消毒。经实验测试,本设计在先端部温升、成像分辨率、视场角和视向角、弯角范围、照度、电介质强度和漏电流项目均符合国家标准要求。为了让研究设计的便携电子可视喉镜能顺利获准注册上市,本文作者结合自身的工作经历,对中国境内第二类医疗器械产品注册申报流程和常见问题进行了较深入的研究,捋顺了注册申报的流程及法规要求,并就医疗器械产品设计和开发过程的合规性问题进行了探讨。并从食药监部门现场检查人员的角度,提出了对医疗器械生产企业实施GMP现场检查时的关注点。最后,对医疗器械生产企业的产品设计和开发以及注册申报环节提出建议,以期为医疗器械生产企业申报注册时提供参考。本文设计的便携电子可视喉镜可以帮助医生在可视下完成气管插管术,特别是对困难气道的处理。今后改进的方向包括:实现无线传输功能和进一步增强图像的清晰度和处理功能,以更好地满足临床使用要求。
[Abstract]:Emergency tracheal intubation is one of the most widely used measures in emergency department, which plays an important role in saving the lives of patients with acute and severe diseases and reducing the mortality rate. However, if there is a difficult airway, even a trained anesthesiologist may not be able to complete the intubation many times. The mortality caused by the failure of the tracheal intubation in the difficult airway is also high. However, for the treatment of difficult airways, the equipment that has been put on the market at present has certain limitations, such as direct laryngoscope can not be used in difficult cases of mouth opening, leaf type visual laryngoscope cannot be used in patients with cervical ankylosis, and fiberoptic bronchoscopy is expensive. Maintenance is difficult and is not easy to use. In order to improve the success rate of intubation in difficult airways, a cold light source with LED, a miniaturized front camera and a soft lens insertion part are designed in this paper, which can synchronously observe and record video, can automatically adjust white balance and prevent fluid from entering. Portable electronic visual laryngoscope resistant to cleaning and disinfection. During tracheal intubation, especially in the treatment of difficult airway, the image of glottis and oropharynx can be clearly displayed, and the one-time tracheal intubation can be guided through the oropharynx, larynx, epiglottis, glottis, and finally to the trachea. It can improve the success rate of tracheal intubation and reduce airway injury. The device has the advantages of good imaging effect, simple operation and suitable price. The portable electronic visual laryngoscope is designed in this paper. The key parts of the electronic system are TMS320DM368 video processor made by TI brand in USA. The features of the high frequency electronic visual laryngoscope and the integrated peripheral can not only guarantee the system performance but also reduce the size of the circuit board. The camera module uses the OV6920 CMOS photosensitive chip of OMNIVISION Company of USA, its width is only 1 / 18 inch, its size is small, the power consumption is low, and the imaging effect is clear, which is very suitable for this design. The mechanical structure is designed in accordance with the current electronic soft mirror. The apex head is integrated with the camera module and the LED lamp. The bending part is designed to bend 180 掳by "snake bone" pending section. The insertion part is a hollow hose with a multi-layer polyurethane coating on the surface. Soft and durable; the display and handle interface with innovative card rotation immediately followed by the socket, the two are easy to separate, the lower part of the handle can be separately soaking and sterilizing. The experimental results show that the temperature rise, imaging resolution, field angle and direction angle, angle range, illuminance, dielectric strength and leakage current of the design meet the requirements of the national standard. In order to allow the portable electronic visual laryngoscope to be successfully registered and listed, the author, in combination with his own work experience, made a deep study on the registration process and common problems of the second kind of medical device products in China. The process and regulations of registration and application are straightened out, and the problems of compliance in the design and development of medical device products are discussed. From the point of view of the field inspectors of the food and drug supervision department, this paper puts forward the focus of the GMP field inspection for the medical device manufacturing enterprises. Finally, some suggestions on product design and development of medical device manufacturing enterprises and registration application are put forward in order to provide reference for medical device manufacturing enterprises to declare and register. The portable electronic visual laryngoscope designed in this paper can help doctors to complete tracheal intubation under visual, especially for difficult airway. Future improvements include wireless transmission and further enhancement of image clarity and processing to better meet the requirements of clinical use.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：TH785.4

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