本文選題：氣管插管術(shù) + 喉鏡��； 參考：《南方醫(yī)科大學(xué)》2017年碩士論文

【摘要】：緊急氣管插管是急診科搶救患者中應(yīng)用最多的措施之一,其對挽救急重癥患者生命、降低死亡率起著重大作用。但若碰到困難氣道,即便是經(jīng)過正規(guī)訓(xùn)練的麻醉醫(yī)師也有可能出現(xiàn)氣管插管多次不能完成的情況,因困難氣道氣管插管失敗所致的死亡率也是居高不下,而對于困難氣道的處理,目前已上市的設(shè)備存在一定的局限性,如直接喉鏡不能用于張口困難病例;葉片式可視喉鏡不能用于頸強(qiáng)直患者;而纖維支氣管鏡價(jià)格昂貴、維修困難、不易上手。為提高困難氣道的插管成功率,本文研究設(shè)計(jì)出一種帶LED冷光源、微型化前置攝像頭、軟鏡插入部,可同步觀察和錄制視頻、可自動(dòng)調(diào)節(jié)白平衡,防進(jìn)液、耐清潔消毒的便攜電子可視喉鏡。在施行氣管插管術(shù)時(shí),尤其是困難氣道的處理中,可以清楚地顯示聲門及口咽部位的腔內(nèi)圖像,引導(dǎo)一次性氣管插管通過口咽部、喉口、會(huì)厭、聲門,最終到達(dá)氣管,可提高氣管插管的成功率,降低氣道損傷。該裝置成像效果好、操作簡便,價(jià)格適宜的特點(diǎn)具有顯著的臨床意義。本文設(shè)計(jì)的便攜電子可視化喉鏡,電子系統(tǒng)的關(guān)鍵件采用美國TI品牌的TMS320DM368視頻處理器,其高頻率(432MHz)和集成型外設(shè)的特點(diǎn)既保證了系統(tǒng)性能又可縮小電路板尺寸,減輕了產(chǎn)品重量;攝像頭模組采用美國OMNIVISION公司的OV6920型CMOS感光芯片,寬度僅有1/18英寸,其尺寸小、功耗低、成像效果清晰的特點(diǎn)非常適合本設(shè)計(jì);機(jī)械結(jié)構(gòu)部分采用與目前的電子軟鏡一致的設(shè)計(jì),先端頭集成了攝像頭模組及LED燈,彎曲部采用“蛇骨”(Bending Section)設(shè)計(jì)實(shí)現(xiàn)180°彎曲,插入部為空心軟管,表面涂有多層的聚氨酯,柔軟且耐用;顯示器與手柄的接口采用創(chuàng)新性的卡式旋轉(zhuǎn)緊接插口,兩者便于分離,手柄以下部分可單獨(dú)浸泡消毒。經(jīng)實(shí)驗(yàn)測試,本設(shè)計(jì)在先端部溫升、成像分辨率、視場角和視向角、彎角范圍、照度、電介質(zhì)強(qiáng)度和漏電流項(xiàng)目均符合國家標(biāo)準(zhǔn)要求。為了讓研究設(shè)計(jì)的便攜電子可視喉鏡能順利獲準(zhǔn)注冊上市,本文作者結(jié)合自身的工作經(jīng)歷,對中國境內(nèi)第二類醫(yī)療器械產(chǎn)品注冊申報(bào)流程和常見問題進(jìn)行了較深入的研究,捋順了注冊申報(bào)的流程及法規(guī)要求,并就醫(yī)療器械產(chǎn)品設(shè)計(jì)和開發(fā)過程的合規(guī)性問題進(jìn)行了探討。并從食藥監(jiān)部門現(xiàn)場檢查人員的角度,提出了對醫(yī)療器械生產(chǎn)企業(yè)實(shí)施GMP現(xiàn)場檢查時(shí)的關(guān)注點(diǎn)。最后,對醫(yī)療器械生產(chǎn)企業(yè)的產(chǎn)品設(shè)計(jì)和開發(fā)以及注冊申報(bào)環(huán)節(jié)提出建議,以期為醫(yī)療器械生產(chǎn)企業(yè)申報(bào)注冊時(shí)提供參考。本文設(shè)計(jì)的便攜電子可視喉鏡可以幫助醫(yī)生在可視下完成氣管插管術(shù),特別是對困難氣道的處理。今后改進(jìn)的方向包括:實(shí)現(xiàn)無線傳輸功能和進(jìn)一步增強(qiáng)圖像的清晰度和處理功能,以更好地滿足臨床使用要求。
[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 擄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.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：TH785.4

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