本发明属于医疗器械技术领域，涉及一种心电超声内窥镜结合的多模态气切装置。The invention belongs to the technical field of medical devices and relates to a multi-modal tracheotomy device combined with an electrocardiogram and ultrasound endoscope.
经皮气管旋切术是一种外科手术中用来建立人工气道常用的方法，属于微创手术。目前常见的经皮气管旋切术操作规范，是先用穿刺针进行穿刺定位，随后置入导丝，以导丝为引导将螺旋器旋转扩张气管造口至需求口径后，旋转取出螺旋器，随后完成导管的置入。由于穿刺过程不可视，存在穿刺到血管毗邻的甲状腺的风险，螺旋器旋切操作过程同样不可视，存在螺旋器进入气道后穿透气道后壁造成气管食道瘘的风险。综上所述，手术“盲穿”过程容易对患者造成伤害，且对操作人员手术经验的依赖性较大。Percutaneous tracheal excision is a common method used to establish an artificial airway during surgery and is a minimally invasive procedure. The current common percutaneous tracheal excision operation specification is to first use a puncture needle to perform puncture positioning, then insert a guide wire, use the guide wire as a guide to rotate the spiral to expand the tracheostomy to the required caliber, rotate the spiral to remove the spiral, and then complete the catheter insertion. Since the puncture process is not visible, there is a risk of puncturing the thyroid gland adjacent to the blood vessel. The spiral excision operation process is also not visible, and there is a risk of the spiral entering the airway and penetrating the posterior wall of the airway, causing a tracheoesophageal fistula. In summary, the "blind puncture" process of the operation is likely to cause harm to the patient and is highly dependent on the operator's surgical experience.
申请号为201220395522.2的实用新型专利中，介绍了一种气管内窥镜系统，用于引导气管切开插管进入气道，所述镜管为硬质弧形镜管，镜管内设有传像通道和光路通道，每个通道内设有一组用于成像的棱镜，镜管为硬质管具有很高的硬度，不宜扭曲耐压迫，起到很好的支撑作用，避免了因气管扭曲引起的患者喉咙受损，但是由于镜管过硬和棱镜的设计，造成镜管不易弯曲调节，其成像角度和观察到的图像信息明显受限，不能全方位观察在进行经皮气管切开术时螺旋器在气管内的位置，存在应用限制。The utility model patent with application number 201220395522.2 introduces a tracheoscopic endoscope system for guiding a tracheotomy tube into the airway. The endoscope tube is a hard curved endoscope tube, and an image transmission channel and an optical path channel are provided in the endoscope tube. A group of prisms for imaging are provided in each channel. The endoscope tube is a hard tube with high hardness, is not easy to twist and is resistant to compression, and plays a good supporting role, thereby avoiding damage to the patient's throat caused by tracheal distortion. However, due to the excessive hardness of the endoscope tube and the design of the prism, the endoscope tube is not easy to bend and adjust, and its imaging angle and observed image information are obviously limited. It is impossible to observe the position of the spiral device in the trachea during percutaneous tracheotomy in all directions, and there are application limitations.
申请号为202111476101.2的发明专利中，介绍了一种新型3D支气管内窥镜系统，支气管镜是一种经口或鼻置入患者下呼吸道观察病变的医疗器械，将两组成像镜头获得的图像进行3D图像融合，生成三维图像，可实现气道内精准测量，对病变位置进行全方位评估。虽然通过图像处理，形成3D图像，但是只能观察到气道内表面的图像信息，无法得到气道内多层次的图像信息，对螺旋器旋切进入气管的位置无法精准把控，对气道内图像多角度的观察也受限。The invention patent with application number 202111476101.2 introduces a new type of 3D bronchoscope system. A bronchoscope is a medical device that is placed into the patient's lower respiratory tract through the mouth or nose to observe lesions. The images obtained by two sets of imaging lenses are fused into 3D images to generate a three-dimensional image, which can achieve accurate measurement in the airway and conduct a comprehensive assessment of the location of the lesion. Although 3D images are formed through image processing, only the image information of the inner surface of the airway can be observed, and the multi-level image information in the airway cannot be obtained. The position of the spiral cutting into the trachea cannot be accurately controlled, and the observation of the multi-angle image in the airway is also limited.
针对以上专利不足和当前“盲穿”法存在的问题，将心电、超声、内窥镜结合起来形成一种多模态气切装置用于经皮气管旋切术对实现可视化、解决“盲穿”误穿风险、提高手术成功率具有重要意义。In view of the above patent deficiencies and the problems existing in the current "blind penetration" method, combining electrocardiography, ultrasound, and endoscopy to form a multimodal tracheostomy device for percutaneous tracheal rotational resection is of great significance for achieving visualization, solving the risk of "blind penetration" and improving the success rate of the operation.
发明内容Summary of the invention
本发明目的在于提供一种心电超声内窥镜结合的多模态气切装置，在手术操作过程中，通过超声图像和内窥镜图像实现可视化的手术操作过程，并在可视化过程中通过心电系统实现对患者体征信息的监测，解决了当前经皮气管旋切术存在的穿刺定位和气管切口扩张过程的不可视、易穿透气管后壁造成气管食道瘘的问题。The purpose of the present invention is to provide a multi-modal tracheostomy device combined with electrocardiography and ultrasound endoscope. During the operation, the surgical operation process is visualized through ultrasound images and endoscopic images, and the patient's vital signs are monitored through the electrocardiography system during the visualization process, which solves the problems of puncture positioning and tracheal incision expansion process in current percutaneous tracheotomy. The problem of being invisible and easily penetrating the posterior tracheal wall to cause tracheoesophageal fistula.
为了实现上述目的，本发明通过以下技术方案实现：In order to achieve the above object, the present invention is implemented by the following technical solutions:
一种心电超声内窥镜结合的多模态气切装置，由穿刺针、导丝、螺旋器、气管切开插管、心电系统、超声系统、内窥镜系统、数据处理及成像显示系统组成；所述心电系统包括多个导联电极、心电传输装置；将心电系统的多个导联电极固定在患者身体部位，采集人体心电信号；所述超声系统包括超声探头、超声手柄、超声成像系统、超声显示屏、超声传输装置，所述超声手柄上有一指示灯，所述超声显示屏位于超声手柄上；所述内窥镜系统包括镜头、照明系统、内窥镜镜管、控制手柄、内窥镜成像系统、内窥镜显示屏、内窥镜传输装置；所述内窥镜镜管是多腔管，内窥镜镜管内有导丝，内窥镜镜管具有具有可弯曲性，所述控制手柄上包含调节按钮、拍照按钮、照明调节按钮和指示灯，所述控制手柄可以调控内窥镜镜管的弯曲方向和角度，所述内窥镜显示屏位于控制手柄上以进行内窥镜图像显示，所述内窥镜镜管外表面涂有一层超滑抗菌层；所述数据处理及成像显示系统包括主机、主显示屏、数据处理系统，所述主机上设置有多个连接口，分别与心电系统、超声系统、内窥镜系统连接，所述主显示屏包括心电模块、超声模块和内窥镜模块；所述主显示屏可同时显示心电图、超声图像、内窥镜图像；所述数据处理系统可同步接收、处理由心电系统、超声系统、内窥镜系统传输的信号，在主显示屏上进行相应的心电图、超声图、内窥镜图像显示，主显示屏可同时显示心电图、超声图像、内窥镜图像。A multimodal tracheotomy device combined with an electrocardiogram and ultrasound endoscope, comprising a puncture needle, a guide wire, a spiral device, a tracheotomy tube, an electrocardiogram system, an ultrasound system, an endoscope system, and a data processing and imaging display system; the electrocardiogram system comprises a plurality of lead electrodes and an electrocardiogram transmission device; the plurality of lead electrodes of the electrocardiogram system are fixed to a patient's body part to collect the human electrocardiogram signal; the ultrasound system comprises an ultrasound probe, an ultrasound handle, an ultrasound imaging system, an ultrasound display screen, and an ultrasound transmission device; an indicator light is provided on the ultrasound handle, and the ultrasound display screen is located on the ultrasound handle; the endoscope system comprises a lens, a lighting system, an endoscope tube, a control handle, an endoscope imaging system, an endoscope display screen, and an endoscope transmission device; the endoscope tube is a multi-lumen tube, a guide wire is provided in the endoscope tube, the endoscope tube is flexible, and the control handle comprises an adjustment button, The camera button, lighting adjustment button and indicator light are provided. The control handle can adjust the bending direction and angle of the endoscope tube. The endoscope display screen is located on the control handle to display the endoscope image. The outer surface of the endoscope tube is coated with an ultra-smooth antibacterial layer. The data processing and imaging display system includes a host, a main display screen, and a data processing system. The host is provided with multiple connection ports, which are respectively connected to the electrocardiogram system, the ultrasound system, and the endoscope system. The main display screen includes an electrocardiogram module, an ultrasound module, and an endoscope module. The main display screen can simultaneously display an electrocardiogram, an ultrasound image, and an endoscope image. The data processing system can synchronously receive and process signals transmitted by the electrocardiogram system, the ultrasound system, and the endoscope system, and display the corresponding electrocardiogram, ultrasound image, and endoscope image on the main display screen. The main display screen can simultaneously display an electrocardiogram, an ultrasound image, and an endoscope image.
进一步，所述心电系统通过将多个导联电极固定在患者身体部位，采集患者心电信号，将采集到的信号通过心电传输装置传输给数据处理及成像显示系统，进行数据处理后，在主显示屏的心电模块进行相应的心电图像显示。Furthermore, the ECG system collects ECG signals from the patient by fixing a plurality of lead electrodes on parts of the patient's body, and transmits the collected signals to a data processing and imaging display system through an ECG transmission device. After data processing, the ECG module on the main display screen displays the corresponding ECG image.
进一步，所述超声系统的超声探头与超声手柄相连，超声探头用于发射超声波并接受反射回的超声信号，超声探头将超声信号传输给超声成像系统，超声成像系统对信号进行处理后传输给超声显示屏进行超声图像显示，超声传输装置继续将超声图像传输给主机，数据处理及成像显示系统接收到超声图像，在主显示屏上的超声模块进行超声图像显示。Furthermore, the ultrasonic probe of the ultrasonic system is connected to the ultrasonic handle, and the ultrasonic probe is used to emit ultrasonic waves and receive reflected ultrasonic signals. The ultrasonic probe transmits the ultrasonic signal to the ultrasonic imaging system, and the ultrasonic imaging system processes the signal and transmits it to the ultrasonic display screen for ultrasonic image display. The ultrasonic transmission device continues to transmit the ultrasonic image to the host, and the data processing and imaging display system receives the ultrasonic image, and the ultrasonic module on the main display screen displays the ultrasonic image.
进一步，所述超声显示屏位于超声手柄上，超声显示屏屏幕方向面对操作人员，可直接在超声显示屏中观察超声图像，也可通过主显示屏观察图像，超声显示屏可进行一定角度旋转，操作者在手持超声手柄时调整合适的角度。Furthermore, the ultrasound display screen is located on the ultrasound handle, and the screen direction of the ultrasound display screen faces the operator. The ultrasound image can be observed directly on the ultrasound display screen, or the image can be observed through the main display screen. The ultrasound display screen can be rotated at a certain angle, and the operator adjusts the appropriate angle when holding the ultrasound handle.
进一步，所述内窥镜系统的内窥镜镜管与镜头连接处为头端，与控制手柄连接处为尾端，内窥镜镜管头端进行圆滑处理，避免造成组织划伤，同时起到保护镜头的作用。所述内窥镜镜管头端外径尺寸为1-5mm，与螺旋器的内径尺寸相匹配，保证镜头贴合在螺旋器的尖端位置并可将内窥镜镜管插入到螺旋器中。Furthermore, the endoscope tube of the endoscope system is connected to the lens at the head end, and connected to the control handle at the tail end. The endoscope tube head end is rounded to avoid tissue scratches and protect the lens. The outer diameter of the endoscope tube head end is 1-5mm, which matches the inner diameter of the spiral device, ensuring that the lens fits at the tip of the spiral device. The endoscope tube can be inserted into the spiral device.
进一步，螺旋器外表面也涂有一层超滑抗菌层。内窥镜镜管外表面和螺旋器外表面的超滑抗菌层材质相同，均为亲水涂层。所述超滑抗菌层均采用浸泡成膜的方式实现在内窥镜镜管外表面和螺旋器外表面的涂覆，使内窥镜镜管外表面和螺旋器外表面较为光滑。Furthermore, the outer surface of the spiral is also coated with a super-smooth antibacterial layer. The super-smooth antibacterial layer on the outer surface of the endoscope tube and the outer surface of the spiral is made of the same material, which is a hydrophilic coating. The super-smooth antibacterial layer is coated on the outer surface of the endoscope tube and the outer surface of the spiral by immersion film formation, making the outer surface of the endoscope tube and the outer surface of the spiral relatively smooth.
进一步，所述内窥镜镜管为三腔至五腔的多腔管，包含图像采集腔道、照明腔道和空腔道，其中图像采集腔道位于中心位置，照明腔道和空腔道均围绕图像采集腔道对称分布，其中图像采集腔道为1个，照明腔道为2-4个，空腔道为2-4个，所述图像采集腔道头端连接着镜头，照明腔道连接着照明系统，空腔道用于注射生理盐水。Furthermore, the endoscope tube is a multi-lumen tube with three to five lumens, including an image acquisition lumen, an illumination lumen and a hollow lumen, wherein the image acquisition lumen is located at the center, and the illumination lumen and the hollow lumen are symmetrically distributed around the image acquisition lumen, wherein there is 1 image acquisition lumen, 2-4 illumination lumen, and 2-4 hollow lumen, the head end of the image acquisition lumen is connected to a lens, the illumination lumen is connected to a lighting system, and the hollow lumen is used for injecting physiological saline.
进一步，所述内窥镜镜管的空腔道用于对镜头进行冲洗，冲刷镜头上的污染。Furthermore, the hollow channel of the endoscope tube is used to flush the lens to wash away the contamination on the lens.
进一步，所述内窥镜镜管内有四根导丝，通过控制手柄调节导丝发生移动可以使内窥镜镜管发生弯曲，通过控制手柄控制内窥镜镜管头端的弯曲角度和方向，可以进行上下左右四个方向的角度调节，在各方向弯曲角度可达0°-180°。Furthermore, there are four guide wires in the endoscope tube. The endoscope tube can be bent by adjusting the movement of the guide wires through the control handle. The bending angle and direction of the head end of the endoscope tube can be controlled by the control handle. The angle can be adjusted in four directions of up, down, left and right. The bending angle in each direction can reach 0°-180°.
进一步，所述内窥镜系统通过内窥镜成像系统对镜头采集的图像信息进行处理，以图像方式呈现在内窥镜显示屏中，内窥镜传输装置将内窥镜图像继续传输给数据处理及成像显示系统，在主显示屏中同时进行内窥镜图像显示；所述镜头在图像采集过程中通过控制手柄进行角度调节，所述照明调节按钮可以用于调节照明系统的光线强度。Furthermore, the endoscope system processes the image information collected by the lens through the endoscope imaging system and presents it in the form of an image on the endoscope display screen. The endoscope transmission device continues to transmit the endoscope image to the data processing and imaging display system, and the endoscope image is simultaneously displayed on the main display screen. The lens is adjusted in angle through the control handle during the image acquisition process, and the lighting adjustment button can be used to adjust the light intensity of the lighting system.
进一步，所述内窥镜显示屏位于控制手柄上，控制手柄通过内窥镜传输装置与主机相连。Furthermore, the endoscope display screen is located on a control handle, and the control handle is connected to the host through an endoscope transmission device.
进一步，所述超声显示屏和主显示屏同步超声图像，所述内窥镜显示屏和主显示屏同步内窥镜图像。所述超声显示屏、内窥镜显示屏均可旋转，可旋转角度为0°-90°。Furthermore, the ultrasound display screen and the main display screen synchronize ultrasound images, and the endoscope display screen and the main display screen synchronize endoscope images. Both the ultrasound display screen and the endoscope display screen can rotate, and the rotation angle can be 0°-90°.
进一步，所述数据处理及成像显示系统可同步接收、处理心电系统、超声系统和内窥镜系统传输的信号，心电模块、超声模块和内窥镜模块各模块间独立控制，通过切换各个模块进行相对应的图像显示，显示屏可同时呈现超声图、心电图、内窥镜图像中的一种至三种，可实时监测心电信号，可实时观察患者体内的情况。Furthermore, the data processing and imaging display system can synchronously receive and process signals transmitted by the ECG system, ultrasound system and endoscope system. The ECG module, ultrasound module and endoscope module are independently controlled, and corresponding images are displayed by switching each module. The display screen can simultaneously present one to three of the ultrasound image, ECG image and endoscope image, and can monitor ECG signals in real time and observe the condition inside the patient's body in real time.
进一步的，所述数据处理系统对接收的心电信号处理后，通过超声传输装置和内窥镜传输装置将指令传输到超声系统和内窥镜系统中，控制超声系统和内窥镜系统的指示灯闪烁；所述超声系统和内窥镜系统的指示灯有两种状态，一种是绿灯常亮，表示患者情况正常，另一种是红灯闪烁，表示患者情况异常。Furthermore, after processing the received ECG signal, the data processing system transmits instructions to the ultrasound system and the endoscope system through the ultrasound transmission device and the endoscope transmission device to control the indicator lights of the ultrasound system and the endoscope system to flash; the indicator lights of the ultrasound system and the endoscope system have two states, one is that the green light is always on, indicating that the patient is in a normal condition, and the other is that the red light flashes, indicating that the patient is in an abnormal condition.
进一步，所述主机连接口有2-3个，连接口为2个时，其中一个连接口直接与超声传输装置连接，另一连接口处有两个数据线分支分别与心电传输装置、内窥镜传输装置连接，连接口为3个时，3个连接口分别与心电传输装置、超声传输装置、内窥镜传输装置连接。Furthermore, the host has 2-3 connection ports. When there are 2 connection ports, one of the connection ports is directly connected to the ultrasonic transmission device, and the other connection port has two data line branches that are respectively connected to the ECG transmission device and the endoscopic transmission device. When there are 3 connection ports, the three connection ports are respectively connected to the ECG transmission device, the ultrasonic transmission device, and the endoscopic transmission device.
本发明提供的技术方案带来的有益效果包括：The beneficial effects brought about by the technical solution provided by the present invention include:
(1)本发明将心电系统、超声系统、内窥镜系统进行结合，在进行经皮气管旋切术的过程中同时实现超声定位穿刺、可视化气管切口扩张和心电监测；(1) The present invention combines an electrocardiogram system, an ultrasound system, and an endoscope system to simultaneously achieve ultrasound-guided puncture, visualized tracheal incision dilation, and electrocardiogram monitoring during percutaneous tracheotomy;
(2)通过超声系统实现经皮气管切开术的穿刺定位、内窥镜镜管的穿刺定位及整个穿刺进入过程的可视化，超声影像可观察到多层次的气管组织结构，避免使用盲穿法在穿刺过程对甲状腺或其他组织造成损伤，通过超声系统可观察内窥镜镜管插入气管的过程，实现了精准穿刺；(2) The ultrasound system can be used to realize the puncture positioning of percutaneous tracheotomy, the puncture positioning of the endoscope tube, and the visualization of the entire puncture entry process. Ultrasound images can observe the multi-layered tracheal tissue structure, avoiding damage to the thyroid gland or other tissues during the puncture process using the blind puncture method. The ultrasound system can be used to observe the process of the endoscope tube being inserted into the trachea, thus achieving precise puncture.
(3)通过内窥镜图像观察螺旋器在气管内部表面的图像，实现了使用螺旋器在进行扩张气管切口过程的可视化，内窥镜镜管和螺旋器的超滑抗菌层设计，可有效减少与切口处皮肤组织的摩擦、降低对周围皮肤组织损伤、减少出血量，通过控制手柄调控镜头角度和方向，实现对穿刺位置的多角度观察；(3) The image of the spiral on the inner surface of the trachea is observed through the endoscope image, which realizes the visualization of the process of using the spiral to dilate the tracheal incision. The ultra-slip antibacterial layer design of the endoscope tube and the spiral can effectively reduce the friction with the skin tissue at the incision, reduce the damage to the surrounding skin tissue, and reduce the amount of bleeding. The angle and direction of the lens can be adjusted by the control handle to achieve multi-angle observation of the puncture position;
(4)通过超声系统与内窥镜系统的结合为气管切口扩张过程提供多维度图像，通过超声和内窥镜精准把握螺旋器的穿刺方向和位置，通过超声图像观察到内窥镜镜管、螺旋器在气管内的位置信息，避免对周围组织的损伤，通过内窥镜图像观察到螺旋器所接触的气管内壁图像，将超声、内窥镜图像结合，将多层次的图像信息进行结合，实现多维度位置信息监测，实现了从穿刺到气管切开插管结束整个手术过程的可视化，有效避免了对气管周围组织损伤以及穿透气道后壁造成气管食道瘘的发生，提高了手术成功率；(4) The combination of the ultrasound system and the endoscope system provides multi-dimensional images for the tracheal incision dilation process, and the puncture direction and position of the spiral device are accurately grasped through ultrasound and endoscope. The position information of the endoscope tube and the spiral device in the trachea is observed through the ultrasound image to avoid damage to the surrounding tissues. The image of the tracheal inner wall contacted by the spiral device is observed through the endoscopic image. The ultrasound and endoscope images are combined, and the multi-level image information is combined to realize multi-dimensional position information monitoring, and the visualization of the entire surgical process from puncture to tracheotomy intubation is realized, which effectively avoids damage to the surrounding tissues of the trachea and the occurrence of tracheoesophageal fistula caused by penetration of the posterior wall of the airway, thereby improving the success rate of the operation;
(5)数据处理及成像显示系统根据监测到的心电信号发出指令到超声系统和内窥镜系统，通过指示灯提示，实现了心电系统与超声系统和内窥镜系统的结合；主显示屏可同时显示超声图像和内窥镜图像，通过将两种图像结合可观察到多维度的图像信息，便于位置判断。(5) The data processing and imaging display system sends instructions to the ultrasound system and the endoscope system based on the monitored ECG signals. The indicator lights are used to realize the integration of the ECG system with the ultrasound system and the endoscope system. The main display screen can display the ultrasound image and the endoscope image at the same time. By combining the two images, multi-dimensional image information can be observed, which is convenient for position judgment.
图1为本发明多模态气切装置的信号传输框图。FIG1 is a signal transmission block diagram of the multi-modal tracheostomy device of the present invention.
图2为本发明多模态气切装置的心电信号传输框图。FIG. 2 is a block diagram of the ECG signal transmission of the multi-modal tracheotomy device of the present invention.
图3为本发明的内窥镜系统与主机连接的示意图。FIG. 3 is a schematic diagram showing the connection between the endoscope system of the present invention and a host computer.
图4为本发明的内窥镜系统的内窥镜镜管的剖面示意图。FIG. 4 is a schematic cross-sectional view of an endoscope tube of the endoscope system of the present invention.
其中，1-镜头，2-内窥镜镜管，3-内窥镜显示屏，4-指示灯，5-拍照按钮，6-照明调节按钮，7-控制手柄，8-内窥镜传输装置，9-主机，10-主显示屏，11-图像采集腔道，12-照明腔道，13-空腔道。Among them, 1-lens, 2-endoscope tube, 3-endoscope display screen, 4-indicator light, 5-photograph button, 6-lighting adjustment button, 7-control handle, 8-endoscope transmission device, 9-host, 10-main display screen, 11-image acquisition cavity, 12-lighting cavity, 13-cavity channel.
为便于理解本发明的目的、技术方案及效果，下面参考附图结合实施例来详细介绍本发明。To facilitate understanding of the objectives, technical solutions and effects of the present invention, the present invention is described in detail below in conjunction with embodiments with reference to the accompanying drawings.
参见附图1-4，本发明的一种心电超声内窥镜结合的多模态气切装置包括：穿刺针、导丝、螺旋器、气管切开插管、心电系统、超声系统、内窥镜系统、数据处理及成像显示系统；所述心电系统包括多个导联电极、心电传输装置；所述超声系统包括超声探头、超声手柄、超声成像系统、超声显示屏、超声传输装置，超声探头与超声手柄相连，所述超声手柄上有指示灯和超声显示屏，超声成像系统、超声传输装置设置在超声手柄内；所述内窥镜系统包括镜头1、照明系统、内窥镜镜管2、控制手柄7、内窥镜成像系统、内窥镜显示屏3、内窥镜传输装置8，内窥镜镜管2包含1个图像采集腔道11、2-4个照明腔道12和2-4个空腔道13。内窥镜镜管的头端与镜头相连，尾端与控制手柄相连，控制手柄上设置有内窥镜显示屏、调节按钮(用于调节内窥镜显示屏的角度)、拍照按钮(用于牌子)、照明调节按钮(用于调节照明系统的亮度)和指示灯，内窥镜成像系统、内窥镜传输装置设置在控制手柄内。所述数据处理及成像显示系统包括主机9、主显示屏10、数据处理系统，主机9的连接口为2个，其中一个连接口直接与超声系统的超声传输装置连接，另一连接口处有两个数据线分支分别与心电系统的心电传输装置、内窥镜系统的内窥镜传输装置连接。Referring to Figures 1-4, a multi-modal tracheostomy device combined with an electrocardiogram and an ultrasound endoscope of the present invention comprises: a puncture needle, a guide wire, a spiral device, a tracheotomy tube, an electrocardiogram system, an ultrasound system, an endoscope system, and a data processing and imaging display system; the electrocardiogram system comprises a plurality of lead electrodes and an electrocardiogram transmission device; the ultrasound system comprises an ultrasound probe, an ultrasound handle, an ultrasound imaging system, an ultrasound display screen, and an ultrasound transmission device, the ultrasound probe is connected to the ultrasound handle, the ultrasound handle is provided with an indicator light and an ultrasound display screen, and the ultrasound imaging system and the ultrasound transmission device are arranged in the ultrasound handle; the endoscope system comprises a lens 1, a lighting system, an endoscope tube 2, a control handle 7, an endoscope imaging system, an endoscope display screen 3, and an endoscope transmission device 8, and the endoscope tube 2 comprises an image acquisition cavity 11, 2-4 lighting cavities 12, and 2-4 hollow cavities 13. The head end of the endoscope tube is connected to the lens, and the tail end is connected to the control handle. The control handle is provided with an endoscope display screen, an adjustment button (for adjusting the angle of the endoscope display screen), a photo button (for brand), a lighting adjustment button (for adjusting the brightness of the lighting system) and an indicator light. The endoscope imaging system and the endoscope transmission device are arranged in the control handle. The data processing and imaging display system includes a host 9, a main display screen 10, and a data processing system. The host 9 has two connection ports, one of which is directly connected to the ultrasound transmission device of the ultrasound system, and the other connection port has two data line branches connected to the ECG transmission device of the ECG system and the endoscope transmission device of the endoscope system.
本发明心电系统、超声系统、内窥镜系统分别与主机连接，各系统间互不影响，独立工作，只是在使用时进行结合使用，通过主机显示屏进行多种图像显示，便于手术观察和操作。通过本发明的多模态气切装置进行经皮气管切开术分为心电信息检测、超声定位引导穿刺、超声内窥镜辅助气管切口扩张的过程。The ECG system, ultrasound system, and endoscope system of the present invention are connected to the host respectively, and the systems do not affect each other and work independently. They are only used in combination when in use, and a variety of images are displayed on the host display screen to facilitate surgical observation and operation. The percutaneous tracheotomy performed by the multimodal tracheotomy device of the present invention is divided into the process of ECG information detection, ultrasound positioning and guiding puncture, and ultrasound endoscope-assisted tracheal incision expansion.
实施例1Example 1
心电信息的采集及监测。心电系统与主机9的连接口进行连接，将导联电极按指示固定在相应的位置，进行信息采集，将采集到的信号通过心电传输装置传输到数据处理及成像显示系统，通过数据处理，在主显示屏10的心电模块进行相应的心电图像显示，实现对人体心律变化的实时监测。ECG information collection and monitoring. The ECG system is connected to the connection port of the host 9, and the lead electrodes are fixed at the corresponding positions as indicated to collect information. The collected signals are transmitted to the data processing and imaging display system through the ECG transmission device. After data processing, the ECG module of the main display screen 10 displays the corresponding ECG image, realizing real-time monitoring of human heart rhythm changes.
实施例2Example 2
超声定位引导穿刺。在超声探头表面涂上耦合剂，将超声探头放于气管喉管处，进行信息采集，通过超声图像观察组织结构，避开甲状腺等组织器官进行穿刺定位，将穿刺针以一定角度穿刺进入气管前壁，直至可抽出大量气体，将导丝插入气管，去除针套，接下来使用螺旋器进行气管开口扩张。Ultrasound positioning guides puncture. Coupling agent is applied to the surface of the ultrasound probe, and the ultrasound probe is placed in the tracheal larynx to collect information. The tissue structure is observed through ultrasound images, and the puncture is positioned to avoid tissues and organs such as the thyroid gland. The puncture needle is inserted into the anterior wall of the trachea at a certain angle until a large amount of gas can be extracted. The guide wire is inserted into the trachea, the needle cover is removed, and then a spiral device is used to dilate the tracheal opening.
超声信号的传递通过以下方式实现：超声探头发射超声波并接受反射回的超声信号，将超声信号传输给超声成像系统，超声成像系统对信号进行处理后传输给超声显示屏进行超声图像显示，超声显示屏可进行0°-90°范围内的角度调节，便于图像观察，超声定位后，医护人员可根据在超声显示屏处观察到的图像信息进行位置标记，超声传输装置同时将超声图像传输给主机9，数据处理及成像显示系统接收到超声图像，在主显示屏10上的超声模块进行超声图像显示。The transmission of ultrasonic signals is achieved in the following way: the ultrasonic probe emits ultrasonic waves and receives the reflected ultrasonic signals. The signal is transmitted to the ultrasound imaging system, which processes the signal and then transmits it to the ultrasound display screen for ultrasound image display. The ultrasound display screen can be adjusted in the range of 0°-90° to facilitate image observation. After ultrasound positioning, medical staff can mark the position according to the image information observed at the ultrasound display screen. The ultrasound transmission device simultaneously transmits the ultrasound image to the host 9. The data processing and imaging display system receives the ultrasound image, and the ultrasound module on the main display screen 10 displays the ultrasound image.
实施例3Example 3
超声内窥镜辅助气管切口扩张的过程。在超声的辅助下，在导丝穿刺点旁另做一内窥镜创口，将用生理盐水沾湿的内窥镜镜管2在内窥镜创口处插入到气管内。The process of endoscopic ultrasound-assisted tracheal incision dilation. Under the assistance of ultrasound, another endoscopic incision is made next to the guide wire puncture point, and the endoscope tube 2 moistened with physiological saline is inserted into the trachea at the endoscopic incision.
在导丝穿刺点两侧做小于8-10mm的水平皮肤切口，将浸过生理盐水的螺旋器以导丝为引导进行气管切口扩张，通过内窥镜图像观察螺旋器在气管内部的穿刺方向，避免螺旋器对气管周围组织的损伤以及穿透气道后壁造成气管食道瘘，通过超声图像观察内窥镜镜管2和螺旋器在气管内的深度以及周围的组织信息，进行位置信息判断，待旋切到位后，将螺旋器以逆时针方向取出，将气管切开插管沿导丝插入气管腔，撤除导丝，进行固定。Make a horizontal skin incision smaller than 8-10mm on both sides of the guidewire puncture point, and use the guidewire to guide the spiral device soaked in normal saline to dilate the tracheal incision. Observe the puncture direction of the spiral device inside the trachea through the endoscopic image to avoid damage to the surrounding tissues of the trachea and penetration of the posterior wall of the airway to cause tracheoesophageal fistula. Observe the depth of the endoscope tube 2 and the spiral device in the trachea and the surrounding tissue information through the ultrasound image to determine the position information. After the spiral cutting is in place, remove the spiral device in a counterclockwise direction, insert the tracheotomy tube into the tracheal cavity along the guidewire, remove the guidewire, and fix it.
内窥镜系统在螺旋器进行气管开口扩张过程中提供图像信息，实现气管开口扩张过程的可视化。内窥镜图像系统对镜头1采集的图像信息进行处理，将图像呈现在内窥镜显示屏3中，可对内窥镜显示屏3进行0°-90°角度内的调整，选择合适的观察角度，通过内窥镜传输装置8将内窥镜图像继续传输给数据处理及成像显示系统，在主显示屏10中同时进行内窥镜图像显示；所述镜头1在图像采集过程中通过控制手柄7进行内窥镜镜管2的弯曲调节，可在各方向进行0°-180°范围内弯曲变化，通过注射器在空腔道13注射生理盐水起到冲洗镜头1的作用，减轻组织液或血液对镜头1的污染，点击拍照按钮5可进行图像拍照，照明系统的光线有低、中、高3档，点击照明调节按钮6可进行照明光线调节，进而保证镜头1采集到的图像清晰。The endoscope system provides image information during the process of the spiral device dilating the tracheal opening, realizing the visualization of the process of the tracheal opening dilation. The endoscope image system processes the image information collected by the lens 1 and presents the image on the endoscope display screen 3. The endoscope display screen 3 can be adjusted within an angle of 0°-90°, and a suitable observation angle can be selected. The endoscope image is further transmitted to the data processing and imaging display system through the endoscope transmission device 8, and the endoscope image is simultaneously displayed on the main display screen 10; during the image acquisition process, the lens 1 adjusts the bending of the endoscope tube 2 through the control handle 7, and can bend and change in the range of 0°-180° in all directions. The lens 1 is flushed by injecting physiological saline in the cavity channel 13 through the syringe, reducing the contamination of the lens 1 by tissue fluid or blood. Clicking the photo button 5 can take pictures. The light of the lighting system has three levels of low, medium and high. Clicking the lighting adjustment button 6 can adjust the lighting light, thereby ensuring that the image collected by the lens 1 is clear.
实施例4Example 4
采用内窥镜镜管2与螺旋器组装的方式，实现超声内窥镜辅助气管切口扩张过程。将内窥镜镜管2头端伸入到螺旋器中固定后使用，在导丝穿刺点两侧做小于8-10mm的水平皮肤切口，使用螺旋器进行气管切口扩张，内窥镜镜管2随螺旋器进入气管内部进行图像采集，内窥镜镜管2头端外径尺寸为1-5mm，与螺旋器的内径尺寸相匹配，保证镜头1贴合在螺旋器的尖端位置，便于观察螺旋器在气管内部的部位。The endoscope tube 2 is assembled with the spiral device to realize the process of tracheal incision expansion assisted by ultrasonic endoscope. The endoscope tube 2 is inserted into the spiral device and fixed before use. A horizontal skin incision less than 8-10 mm is made on both sides of the guide wire puncture point. The spiral device is used to expand the tracheal incision. The endoscope tube 2 enters the trachea with the spiral device to collect images. The outer diameter of the endoscope tube 2 is 1-5 mm, which matches the inner diameter of the spiral device, ensuring that the lens 1 fits at the tip of the spiral device, which is convenient for observing the position of the spiral device inside the trachea.
通过内窥镜传输装置8将采集到的信号传输给数据处理及成像显示系统，将处理后信息再继续传输给内窥镜模块，在主显示屏10中进行图像显示，实现图像采集、传输和显示，在手术过程中医护操作人员可根据需求进行各图像模块的切换，通过内窥镜图像和超声图像双向监测旋切位置，及时调整旋切的角度和力度，对旋切位置进行精准定位，待旋切到位后，将螺旋器逆时针方向取出，气管切开插管沿导丝插入气管腔，撤除导丝，进行固定。The collected signal is transmitted to the data processing and imaging display system through the endoscope transmission device 8, and the processed information is further transmitted to the endoscope module, and the image is displayed on the main display screen 10, realizing image collection, transmission and display. During the operation, medical operators can switch between image modules as needed, monitor the position of the cutting in both directions through endoscopic and ultrasonic images, adjust the angle and strength of the cutting in time, and accurately locate the cutting position. After the cutting is in place, the spiralizer is removed counterclockwise, and the tracheotomy tube is inserted into the tracheal cavity along the guide wire, and the guide wire is removed for fixation.
实施例5Example 5
数据处理及成像显示系统对心电系统、超声系统、内窥镜系统传输的信号进行接收处理，通过数据处理系统进行信号接收和发送工作，将处理后的信号分别传输到对应的心电模块、超声模块和内窥镜模块，主显示屏10上可同时显示心电图、超声图像、内窥镜图像，可自由切换查看对应的图像信息；数据处理系统将监测到的心电信号进行识别，若识别出心电信息正常，发送体征正常的指令到超声系统和内窥镜系统，控制超声手柄和控制手柄7上的指示灯4亮绿灯，若识别出心电信息异常，指示灯4出现红灯闪烁，医护人员在使用超声系统和内窥镜系统时可直接观察指示灯4来判断手术患者的生命体征信息。The data processing and imaging display system receives and processes the signals transmitted by the ECG system, the ultrasound system, and the endoscope system, receives and sends the signals through the data processing system, and transmits the processed signals to the corresponding ECG module, the ultrasound module, and the endoscope module respectively. The main display screen 10 can display the ECG, ultrasound image, and endoscope image at the same time, and the corresponding image information can be switched freely to view the corresponding image information; the data processing system identifies the monitored ECG signal, and if the ECG information is identified as normal, it sends a normal vital sign instruction to the ultrasound system and the endoscope system, controls the indicator light 4 on the ultrasound handle and the control handle 7 to light up green, and if the ECG information is identified as abnormal, the indicator light 4 flashes red. When using the ultrasound system and the endoscope system, medical staff can directly observe the indicator light 4 to judge the vital sign information of the surgical patient.
实施例6Example 6
对9只小型猪进行动物试验，编号为1-9，取编号1、2、3的小型猪进行试验，命名为试验例1、2、3，将心电导联电极固定在左前肢、右前肢，实现体征信息监测，进行超声定位引导穿刺，采用实施例3的方式进行气管切口扩张，在超声辅助下作一内窥镜穿刺创口，将内窥镜插入气管内部，螺旋器以导丝为引导进行气管切口扩张，在使用超声系统和内窥镜系统过程中，通过指示灯4进行体征信息观察，通过内窥镜图像和超声图像对螺旋器在气管内的位置进行观察和调整，待旋切到位后，将螺旋器以逆时针方向取出，将气管切开插管沿导丝插入气管腔，撤除导丝，进行固定。手术是否成功通过内窥镜图像信息显示旋切到位后螺旋器是否触碰到气道后壁来判断，若螺旋器未触碰到气道后壁，则手术成功，反之即手术失败，记录需要观察的指标。Animal experiments were conducted on 9 miniature pigs, numbered 1-9. Miniature pigs numbered 1, 2, and 3 were used for the experiment, named as Experimental Examples 1, 2, and 3. ECG lead electrodes were fixed on the left and right forelimbs to monitor vital signs, and ultrasound positioning and guided puncture were performed. The tracheal incision was expanded in the manner of Example 3. An endoscopic puncture incision was made with the assistance of ultrasound, and the endoscope was inserted into the trachea. The spiral was used to expand the tracheal incision with the guide wire as the guide. During the use of the ultrasound system and the endoscope system, vital signs were observed through the indicator light 4, and the position of the spiral in the trachea was observed and adjusted through the endoscopic image and the ultrasound image. After the spiral was in place, the spiral was removed in a counterclockwise direction, and the tracheotomy tube was inserted into the tracheal cavity along the guide wire, and the guide wire was removed for fixation. The success of the operation is determined by the endoscopic image information showing whether the spiralizer touches the posterior wall of the airway after the spiral cutting is in place. If the spiralizer does not touch the posterior wall of the airway, the operation is successful, otherwise it is a failure. The indicators that need to be observed are recorded.
实施例7Example 7
取编号4、5、6的小型猪进行试验，分别命名为试验例4、5、6，将心电导联电极固定在左前肢、右前肢，实现体征信息监测，进行超声定位引导穿刺，采用实施例4的方式进行气管切口扩张，将内窥镜镜管2伸入到螺旋器中进行固定，确保内窥镜镜管2头端位于螺旋器尖端位置，通过指示灯4进行简单的体征信息观察，通过内窥镜图像和超声图像对螺旋器在气管内的位置进行观察和调整，待旋切到位后，将螺旋器以逆时针方向取出，将气管切开插管沿导丝插入气管腔，撤除导丝，进行固定。手术是否成功通过内窥镜图像信息观察旋切到位后螺旋器是否触碰到气道后壁来判断，若螺旋器未触碰到气道后壁，则手术成功，反之即手术失败，记录需要观察的指标。Miniature pigs numbered 4, 5, and 6 were tested and named as Test Examples 4, 5, and 6, respectively. ECG lead electrodes were fixed on the left and right forelimbs to monitor vital signs, and ultrasound positioning and guided puncture were performed. The tracheal incision was expanded in the manner of Example 4. The endoscope tube 2 was inserted into the spiral device for fixation to ensure that the head end of the endoscope tube 2 was located at the tip of the spiral device. Simple vital signs were observed through the indicator light 4. The position of the spiral device in the trachea was observed and adjusted through the endoscopic image and the ultrasound image. After the spiral was in place, the spiral device was taken out in a counterclockwise direction, and the tracheotomy tube was inserted into the tracheal cavity along the guide wire, and the guide wire was removed for fixation. Whether the operation was successful was judged by observing whether the spiral device touched the posterior wall of the airway after the spiral was in place through the endoscopic image information. If the spiral device did not touch the posterior wall of the airway, the operation was successful, otherwise the operation failed, and the indicators that needed to be observed were recorded.
对比例Comparative Example
采用常规的“盲穿法”进行经皮气管旋切作为对照组，取编号7、8、9的小型猪进行试验，分别命名为对比例1、对比例2、对比例3，直接使用盲穿法进行导丝穿刺和气管切口扩张过程，在进行气管旋切的过程中，由另一操作人员使用支气管内窥镜进行观察，由口腔插入支气管内窥镜，通过观察螺旋器尖端与气道后壁间的位置来评判手术是否成功，若螺旋器未损伤到气道后壁即手术成功，反之即手术失败。记录需要观察的指标。The conventional "blind puncture method" was used for percutaneous tracheal rotation as the control group. Miniature pigs No. 7, 8, and 9 were tested and named as Comparative Example 1, Comparative Example 2, and Comparative Example 3, respectively. The blind puncture method was used directly for guidewire puncture and tracheal incision dilation. During the tracheal rotation, another operator used a bronchoscope for observation. The bronchoscope was inserted from the mouth to observe the position between the spiral tip and the posterior wall of the airway to judge whether the operation was successful. If the spiral did not damage the posterior wall of the airway, the operation was successful, otherwise it was a failure. Record the indicators that need to be observed.
观察指标：Observation indicators:
1、操作时长，从穿刺开始到螺旋器完全撤离人体的时间；1. Operation duration, from the start of puncture to the complete withdrawal of the spiral device from the human body;
2、手术成功率，通过是否对气道后壁造成损伤进行手术成功评判；2. The success rate of the operation, which is judged by whether the posterior wall of the airway is damaged;
3、操作难度反馈，评价操作难度。Ⅰ:无任何困难。Ⅱ:有一些困难，但可以克服。Ⅲ:不可克服的困难，换用其他气切方法。3. Feedback on the difficulty of operation: evaluate the difficulty of operation. Ⅰ: No difficulty. Ⅱ: Some difficulty, but can be overcome. Ⅲ: Insurmountable difficulty, use other tracheostomy methods.
手术结果如表1所示：The surgical results are shown in Table 1:
表1对比例和试验例的手术结果比较
Table 1 Comparison of surgical results between comparative example and test example
由上表信息可知，试验例组的手术成功率几乎达到100％，对比例存在一例失败，手术成功率67％，表明使用本发明的多模态气切装置有效避免了对气道后壁的损伤，避免了气管食道瘘的发生；除此之外，本发明的多模态气切装置进行气管切开手术时与对比例(使用“盲穿法”)相比操作难度明显降低、手术用时明显缩短、手术成功率明显提高；使用试验例1、2、3和试验例4、5、6的手术成功率和手术用时相差不大，表明采用实施例6和实施例7中两种不同内窥镜系统的使用方法产生的手术效果差距不大，提高了多模态气切装置的适用度。因此本发明的多模态气切装置在解决“盲穿”问题的同时可实现监测患者的体征信息，有效提高了经皮气管旋切手术的成功率。From the above table, we can see that the success rate of the operation in the experimental group is almost 100%, while there is one failure in the control group. The power is 67%, indicating that the use of the multimodal tracheostomy device of the present invention effectively avoids damage to the posterior wall of the airway and avoids the occurrence of tracheoesophageal fistula; in addition, the multimodal tracheostomy device of the present invention has significantly reduced operating difficulty, significantly shortened operation time, and significantly improved operation success rate when performing tracheotomy surgery compared with the control example (using the "blind penetration method"); the operation success rate and operation time of Test Examples 1, 2, 3 and Test Examples 4, 5, and 6 are not much different, indicating that the difference in surgical effects produced by the use methods of the two different endoscope systems in Example 6 and Example 7 is not much, which improves the applicability of the multimodal tracheostomy device. Therefore, the multimodal tracheostomy device of the present invention can monitor the patient's vital signs while solving the "blind penetration" problem, effectively improving the success rate of percutaneous tracheal rotational resection.
本发明多模态气切装置包括但不限于应用于气管旋切、泪道引流以及其他腔道或者窦道的操作等，可以将心电系统、超声系统、内窥镜系统、数据处理及成像显示系统进行结合应用于其他手术过程实现可视化操作。The multimodal tracheostomy device of the present invention includes but is not limited to applications in tracheal rotational resection, lacrimal duct drainage, and other cavities or sinus operations, and can be combined with an electrocardiogram system, an ultrasound system, an endoscope system, a data processing and imaging display system and applied to other surgical procedures to achieve visualized operations.
以上内容结合附图对本发明实施例作了详细说明，但是本发明包括但不限于上述实施例，在不脱离本发明宗旨的范围情况下，可以对其进行各种改进和变化，任何本领域的技术人员能思之的变化都应是本发明的保护范围。The above content is combined with the accompanying drawings to provide a detailed description of the embodiments of the present invention, but the present invention includes but is not limited to the above embodiments. Various improvements and changes may be made to the embodiments without departing from the scope of the present invention. Any changes that can be conceived by technicians in this field should be within the scope of protection of the present invention.
| Application Number | Priority Date | Filing Date | Title |
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| CN202211700083.6 | 2022-12-29 | ||
| CN202211700083.6ACN115645013B (en) | 2022-12-29 | 2022-12-29 | Multi-mode tracheotomy device combined with electrocardio ultrasonic endoscope |
| Publication Number | Publication Date |
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| WO2024138974A1true WO2024138974A1 (en) | 2024-07-04 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2023/090481PendingWO2024138974A1 (en) | 2022-12-29 | 2023-04-25 | Electrocardiographic and ultrasonic endoscope-combined multi-modal tracheostomy apparatus |
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| WO (1) | WO2024138974A1 (en) |
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