Research And Design Of The Portable Electronic Visual Laryngoscope

Tracheal intubation is often used for emergency rescue,playing an important role in saving lives and reducing mortality.A successful tracheal intubation depends on the fully exposed glottis.However,the conditions of critically ill patients are diverse.Except for patients with respiratory and cardiac arrest,most patients have a certain degree of muscle tension,which make it difficult to expose glottis fully.In addition,for some patients with thick,short neck,small jaw,small mouth,thick tongue,neck scar contracture,and abnormal anatomy of cervical vertebra,etc.,their glottis can’t be fully exposed for the three anatomical axes of upper respiratory tract(mouth,pharynx,throat axes)are difficult to be adjusted to a straight line.Even the well-trained anesthetist could fail to complete tracheal intubation for patients with difficult airway.The mortality due to the failing tracheal intubation for difficult airway remains high.Some equipments to deal with difficult airway have their limitations,for example,the direct laryngoscope can’t be used for cases with the difficulty in opening mouth;leaf-type video laryngoscope can’t be used for patients with cervical stiffness;fiber optic bronchoscopy is expensive,difficult in maintenance,not easy to use.In order to improve the success rate of tracheal intubation for patients with difficult airway,a portable electronic visual laryngoscope with LED light is designed in the study.The device is equipped with a front camera,soft lens insertion part,the design for synchronous observation and video recording,automatic white balance adjustment,anti-liquid resistance,and the tolerance to cleaning and disinfection.During the implementation of tracheal intubation,especially the treatment of difficult airway,the internal images of the glottis and oropharynx are clearly displayed,leading disposable tracheal catheter through the oropharynx,throat,epiglottis,glottis,eventually reach the trachea,which improves the success rate of tracheal intubation,and reduces airway injury.The proposed device has the characteristics of clear image,easy operation and suitable price,with significant clinical value.The key parts of electronic system in the designed portable electronic visual laryngoscope are from the TMS320DM368 video processor of the U.S.TI company.The characteristics of high frequency(432 MHz)and integrated peripherals ensure the system performance and the smaller size of circuit board,reducing the weight of the product.Camera module is from the OV6920 CMOS photosensitive chip of the U.S.OMNIVISION company,with the width of only 1/18 inches.The small size,low power consumption and better imaging results of camera module are very suitable for this design.The mechanical part is consistent with the electronic soft endoscope.Apex head integrates camera module and LED light;Bending Section design is used for bending part to implement 180° bend insertion;insert part is hollow tube,coated with layers of polyurethane,soft and durable;the helical interface is used for the interface of monitor and handle,which is convenient for the separation of monitor and handle;handle and the following section were carried out the immersion and disinfection alone.The experimental test shows the temperature rise at the apex head,the imaging resolution,the field of view,the angle of view,the angle of the range,intensity,dielectric strength and leakage current of the portable electronic visual laryngoscope meet national standards.In order to register portable video laryngoscope successfully,the author summarizes the common problems and procedure of the second type of medical device registration in China with his own work experience.To make registration procedure smooth and regulatory requirements clear.This paper studies the compliance of medical device product design and development process.From the perspective of the China Food and Drug Administration(CFDA)official,the author points out that medical device manufacturing enterprise should pay attention to the main points in the on-site inspection of GMP(Medical Devices Good Manufacturing Practices).Finally,the author puts some suggestions about the design,development and registration process,providing some reference for medical equipment manufacturers.The portable electronic visual laryngoscope designed in the study helps doctors to complete the tracheal intubation better,especially for the patients with difficult airway.In the future,we should improve the wireless transmission function and further enhance the resolution and processing function of images,so as to meet the clinical requirements better.