CN115581521A - Nerve monitoring system suitable for thyroid tumor ablation and using method thereof - Google Patents

Abstract

Translated fromChinese

本发明涉及一种适用于甲状腺肿瘤消融术的神经监测系统及其使用方法，包括神经刺激针，神经刺激针包括导电针杆和绝缘针柄，导电针杆的一端设置有导电针尖，导电针杆的外表面设置有绝缘层；及神经监测仪，包括主机和显示屏，主机通过第一导线与神经刺激针相连，用于提供刺激信号，主机通过第二导线与记录电极相连，用于监测肌电信号，显示屏与主机相连，用于显示肌电图；本系统，可以与现有的消融系统及超声系统配合使用，可以在消融术中实时监测喉返神经或迷走神经是否受损，使得在消融术中，医生可以及时发现喉返神经或迷走神经是/否受损，从而可以有效防止在消融术中持续损伤神经，达到保护喉返神经和迷走神经的目的。

The invention relates to a nerve monitoring system suitable for thyroid tumor ablation and a method for using the same, comprising a nerve stimulation needle, the nerve stimulation needle includes a conductive needle rod and an insulating needle handle, one end of the conductive needle rod is provided with a conductive needle tip, and the conductive needle rod The outer surface is provided with an insulating layer; and a nerve monitor, including a host and a display screen, the host is connected to the nerve stimulation needle through a first wire for providing stimulation signals, and the host is connected to the recording electrode through a second wire for monitoring muscle Electrical signals, the display screen is connected to the host computer to display electromyography; this system can be used in conjunction with the existing ablation system and ultrasound system, and can monitor in real time whether the recurrent laryngeal nerve or vagus nerve is damaged during ablation, so that During ablation, doctors can detect in time whether the recurrent laryngeal nerve or vagus nerve is damaged, so as to effectively prevent continuous nerve damage during ablation and achieve the purpose of protecting the recurrent laryngeal nerve and vagus nerve.

Description

Translated fromChinese

适用于甲状腺肿瘤消融术的神经监测系统及其使用方法Neural monitoring system suitable for thyroid tumor ablation and method of use thereof

技术领域technical field

本发明涉及消融手术技术领域，具体涉及一种适用于甲状腺肿瘤消融术的神经监测系统。The invention relates to the technical field of ablation surgery, in particular to a nerve monitoring system suitable for thyroid tumor ablation.

背景技术Background technique

人体颈部有多组神经通过，在颈部疾病的外科治疗中，如甲状腺疾病的治疗中，需要尽量保护这些神经组织，以减少手术并发症；比如，喉返神经从迷走神经分支出来，反折至颈部气管两侧，紧贴甲状腺上行，并在甲状软骨附近进入喉腔，喉返神经可以管理除环甲肌以外的喉肌。众所周知，人体的神经组织不能再生，如果在术中出现喉返神经损伤，将导致声带不能正常运动，从而导致患者声音嘶哑，影响生活质量。There are many groups of nerves passing through the neck of the human body. In the surgical treatment of neck diseases, such as the treatment of thyroid diseases, it is necessary to protect these nerve tissues as much as possible to reduce surgical complications; for example, the recurrent laryngeal nerve branches from the vagus nerve. To both sides of the trachea in the neck, it is close to the thyroid gland and ascends, and enters the laryngeal cavity near the thyroid cartilage. The recurrent laryngeal nerve can manage the laryngeal muscles except the cricothyroid muscle. As we all know, the nerve tissue of the human body cannot regenerate. If the recurrent laryngeal nerve is damaged during the operation, the vocal cords will not move normally, which will lead to hoarseness of the patient and affect the quality of life.

在人体的解剖结构中，甲状腺位于人体颈部甲状软骨下方，气管两旁，形状似蝴蝶，犹如盾甲，通常分为左右两叶和峡部，左右两叶位于喉下部与器官上部的两侧面，上端自甲状软骨的中点，下端至第6气管软骨环，有时达胸骨上窝或胸骨后。甲状腺肿瘤是头颈部常见的肿瘤，通常可以采用手术治疗或热消融治疗，但是由于热消融治疗无需进行解剖，创伤更小，在甲状腺肿瘤的治疗中应用得越来越多。In the anatomical structure of the human body, the thyroid gland is located under the thyroid cartilage in the neck of the human body, on both sides of the trachea, shaped like a butterfly, like a scute, and is usually divided into left and right lobes and the isthmus. From the midpoint of the thyroid cartilage, the lower end to the sixth tracheal cartilage ring, sometimes reaching the suprasternal fossa or retrosternal. Thyroid tumors are common tumors in the head and neck, and can usually be treated with surgery or thermal ablation. However, thermal ablation is more and more used in the treatment of thyroid tumors because it does not require dissection and has less trauma.

现有技术中，在甲状腺肿瘤的消融术中，通常会用到消融系统和超声系统，消融系统包括消融针和消融主机，消融针通过导线与消融主机相连，消融主机用于为热消融过程提供能量；在治疗过程中，患者通常处于局部麻醉状态，医护人员可以通过超声系统看到甲状腺肿瘤和消融针，以便在超声系统的实时引导下，将消融针插进甲状腺肿瘤内 (或消融区域内)，消融主机启动，使得消融针尖附近温度达到60℃以上，利用热量使得肿瘤消融，达到治疗的目的。由于喉返神经和迷走神经通常紧贴周围的组织，尤其是喉返神经通常紧贴甲状腺，与离甲状腺肿瘤之间的间距可能很近，因此，在消融甲状腺肿瘤时，医护人员需要特别注意，以防损伤喉返神经。In the prior art, an ablation system and an ultrasound system are usually used in the ablation of thyroid tumors. The ablation system includes an ablation needle and an ablation host. The ablation needle is connected to the ablation host through a wire. The ablation host is used to provide Energy; during the treatment, the patient is usually under local anesthesia, and the medical staff can see the thyroid tumor and the ablation needle through the ultrasound system, so that under the real-time guidance of the ultrasound system, the ablation needle can be inserted into the thyroid tumor (or within the ablation area ), the ablation host is started, so that the temperature near the ablation needle tip reaches above 60°C, and the heat is used to ablate the tumor to achieve the purpose of treatment. Because the recurrent laryngeal nerve and vagus nerve are usually close to the surrounding tissues, especially the recurrent laryngeal nerve is usually close to the thyroid gland, and the distance between the recurrent laryngeal nerve and the thyroid tumor may be very close. Prevent damage to the recurrent laryngeal nerve.

为尽量避免消融过程损伤喉返神经或迷走神经，传统的方式是：医生在手术中通过与患者谈话了解其声音变化来判断喉返神经是否受损伤，一旦患者声音变得嘶哑，表明喉返神经受到了损伤，应该立刻调节消融针的位置，避免喉返神继续受损，从而可以在一定程度上起到保护神经的目的，但是，这种方式依赖医生的经验，且很难在损伤初期就被医生所发现，容易造成神经的持续损伤。基于此，现有技术公开了一些神经监测系统，使得在消融术中，医生可以利用神经监测系统来监测喉返神经是否受损，但是也很难在损伤初期就被医生所发现，例如，中国专利CN 109528297 A公开的一种可进行喉返神经监测的监测系统，包括消融针、消融主机、气管导管、神经监测仪，其中，消融针通过主机线与消融主机连接，并通过探针线与神经监测仪连接，气管导管上设置有记录电极，记录电极通过导线与神经监测仪连接，在术前，需要将气管导管经由患者咽喉插入，并使得记录电极与患者的声带相接触。在消融术中，医生在超声引导下将消融针插入甲状腺、甲状旁腺或其他颈部肿瘤组织内，先开启神经监测仪、关闭消融主机，消融针的针尖产生刺激电流，如果针尖靠近喉返神经或迷走神经，即能激发神经电位，目标喉肌发生收缩，引发声带振动，产生肌电信号，此肌电信号被位于声带的记录电极接收，传回神经监测仪，经过滤波、放大即可显示出肌电图，此时医生可知晓消融针的针尖距离喉返神经或迷走神经距离近，不能进行热消融，需要重新调整针尖的位置，且神经监测仪上无肌电图显示时，医生才关闭神经监测仪、开启消融主机，利用消融主机加热消融针的针尖，针尖通过高温消融周围的肿瘤组织，从而达到治疗的目的。这种神经监测系统也只能在开始消融之前判断针尖周围是否有喉返神经或迷走神经，由于消融过程是利用热能实现消融，热能会辐射一定的范围，且热能不可见，不能直观的判断热能的辐射范围是否覆盖喉返神经或迷走神经，因此医生无法在消融过程中及时发现喉返神经或迷走神经是否受损，也容易造成神经的持续损伤。综上，如何在甲状腺肿瘤消融术中有效保护喉返神经及迷走神经，防止神经被持续损伤，还有待解决。In order to avoid damage to the recurrent laryngeal nerve or vagus nerve during the ablation process, the traditional method is: the doctor talks to the patient during the operation to understand the change of his voice to judge whether the recurrent laryngeal nerve is damaged. Once the patient’s voice becomes hoarse, it indicates that the recurrent laryngeal nerve is damaged. In case of injury, the position of the ablation needle should be adjusted immediately to avoid further damage to the laryngeal recurrent nerve, which can protect the nerve to a certain extent. However, this method relies on the experience of the doctor, and it is difficult to be diagnosed at the initial stage of injury. Doctors have found that it is easy to cause continuous damage to the nerves. Based on this, some nerve monitoring systems are disclosed in the prior art, so that during ablation, doctors can use the nerve monitoring system to monitor whether the recurrent laryngeal nerve is damaged, but it is also difficult to be discovered by doctors at the early stage of damage, for example, China Patent CN 109528297 A discloses a monitoring system capable of monitoring the recurrent laryngeal nerve, including an ablation needle, an ablation host, a tracheal tube, and a nerve monitor. The nerve monitor is connected, and the endotracheal tube is provided with recording electrodes, which are connected to the nerve monitor through wires. Before the operation, the endotracheal tube needs to be inserted through the patient's throat, and the recording electrodes are in contact with the patient's vocal cords. During ablation, the doctor inserts the ablation needle into the thyroid gland, parathyroid gland or other neck tumor tissue under the guidance of ultrasound. Nerve or vagus nerve can stimulate nerve potential, the target laryngeal muscle contracts, triggers vocal cord vibration, and generates myoelectric signal. This myoelectric signal is received by the recording electrode located on the vocal cord and sent back to the nerve monitor, which can be displayed after filtering and amplifying At this time, the doctor can know that the needle tip of the ablation needle is close to the recurrent laryngeal nerve or the vagus nerve, and thermal ablation cannot be performed. The position of the needle tip needs to be readjusted, and the doctor will only turn off the ablation needle when there is no EMG display on the nerve monitor. The nerve monitor turns on the ablation host, uses the ablation host to heat the needle tip of the ablation needle, and the needle tip ablates the surrounding tumor tissue through high temperature, so as to achieve the purpose of treatment. This kind of nerve monitoring system can only judge whether there is recurrent laryngeal nerve or vagus nerve around the needle tip before starting ablation. Since the ablation process uses heat energy to achieve ablation, the heat energy will radiate to a certain range, and the heat energy is invisible, so it cannot be judged intuitively. Whether the radiation range covers the recurrent laryngeal nerve or vagus nerve, so doctors cannot find out whether the recurrent laryngeal nerve or vagus nerve is damaged in time during the ablation process, and it is easy to cause continuous damage to the nerve. In summary, how to effectively protect the recurrent laryngeal nerve and vagus nerve during ablation of thyroid tumors and prevent the nerves from being continuously damaged remains to be solved.

发明内容Contents of the invention

本发明第一方面要解决现有甲状腺肿瘤消融术中，医生无法在消融过程中及时发现喉返神经或迷走神经是否受损，容易造成神经持续损伤的问题，提供了一种适用于甲状腺肿瘤消融术的神经监测系统，与现有的消融系统配合使用，可以在消融的过程中实时监测喉返神经或迷走神经是否受损，以便医生及时调控消融系统，避免持续损伤神经，从而达到保护喉返神经和迷走神经的目的，主要构思为：The first aspect of the present invention is to solve the problem that in the existing thyroid tumor ablation, doctors cannot find out whether the recurrent laryngeal nerve or vagus nerve is damaged in time during the ablation process, which may easily cause continuous damage to the nerves, and provides a thyroid tumor ablation The advanced nerve monitoring system, used in conjunction with the existing ablation system, can monitor in real time whether the recurrent laryngeal nerve or vagus nerve is damaged during the ablation process, so that doctors can adjust the ablation system in time to avoid continuous nerve damage, so as to protect the recurrent laryngeal nerve and The purpose of the vagus nerve is mainly conceived as:

一种适用于甲状腺肿瘤消融术的神经监测系统，包括用于施加刺激信号的神经刺激针，所述神经刺激针包括导电针杆和设置于导电针杆的绝缘针柄，导电针杆的一端设置有导电针尖，导电针杆的外表面设置有绝缘层；A nerve monitoring system suitable for thyroid tumor ablation, comprising a nerve stimulation needle for applying stimulation signals, the nerve stimulation needle includes a conductive needle rod and an insulating needle handle arranged on the conductive needle rod, and one end of the conductive needle rod is arranged There are conductive needle points, and the outer surface of the conductive needle rod is provided with an insulating layer;

记录电极，贴于甲状软骨处的皮肤，用于采集肌电信号；以及Recording electrodes, attached to the skin at the thyroid cartilage, for collecting EMG signals; and

神经监测仪，所述神经监测仪包括主机和显示屏，主机通过第一导线与神经刺激针相连，用于提供刺激信号，主机通过第二导线与记录电极相连，用于监测肌电信号，显示屏与主机通讯连接，至少用于显示由肌电信号所构成的肌电图。本神经监测系统，通过配置神经刺激针，并使得神经刺激针与神经监测仪的主机相连，神经监测仪可以为神经刺激针提供刺激信号，刺激信号可以通过神经刺激针的导电针尖释放到导电针尖所在的位置，解决刺激神经的问题；通过配置记录电极，并使得记录电极与神经监测仪的主机相连，以便利用记录电极采集肌电信号，主机可以根据所采集的肌电信号监测肌电信号的变化情况，并可以通过显示器实时显示肌电图，解决实时监测神经肌电信号的问题；本神经监测系统可以与现有的消融系统以及超声系统配合使用，使得在甲状腺肿瘤消融术中，医生可以通过肌电图的实时变化情况及时发现喉返神经或迷走神经是/否受损，并可以在发现神经受损后及时关闭或调整消融系统，从而可以有效防止消融术中持续损伤神经，达到保护喉返神经和迷走神经的目的。A nerve monitor, the nerve monitor includes a host and a display screen, the host is connected to a nerve stimulation needle through a first wire for providing stimulation signals, the host is connected with a recording electrode through a second wire for monitoring myoelectric signals, and displays The screen is communicatively connected with the host, at least for displaying the electromyogram composed of electromyographic signals. In this nerve monitoring system, by configuring the nerve stimulation needle and connecting the nerve stimulation needle to the host of the nerve monitor, the nerve monitor can provide stimulation signals for the nerve stimulation needle, and the stimulation signal can be released to the conductive needle tip through the conductive needle tip of the nerve stimulation needle location, to solve the problem of nerve stimulation; by configuring the recording electrode and connecting the recording electrode to the host of the nerve monitor, so that the recording electrode can be used to collect the myoelectric signal, the host can monitor the myoelectric signal according to the collected myoelectric signal The EMG can be displayed in real time through the monitor to solve the problem of real-time monitoring of nerve EMG signals; this nerve monitoring system can be used in conjunction with the existing ablation system and ultrasound system, so that doctors can perform thyroid tumor ablation Through the real-time changes of electromyography, it can be detected in time whether the recurrent laryngeal nerve or vagus nerve is damaged, and the ablation system can be turned off or adjusted in time after the nerve damage is found, so as to effectively prevent continuous nerve damage during ablation and protect the larynx. Purpose of the recurrent and vagus nerves.

为解决监测喉返神经是否损伤的问题，进一步的，导电针尖与绝缘针柄之间的间距大于或等于8厘米。使得神经刺激针的导电针尖可以插入到喉返神经的附近处，以便监测喉返神经是否损伤。In order to solve the problem of monitoring whether the recurrent laryngeal nerve is damaged, further, the distance between the conductive needle tip and the insulating needle handle is greater than or equal to 8 cm. The conductive needle tip of the nerve stimulation needle can be inserted near the recurrent laryngeal nerve, so as to monitor whether the recurrent laryngeal nerve is damaged.

优选的，所述导电针尖与绝缘针柄之间的间距为10厘米。Preferably, the distance between the conductive needle tip and the insulating needle handle is 10 cm.

为解决神经刺激针一次性使用的问题，方案一中，所述第一导线的一端连接于绝缘针柄，且第一导线与导电针杆电性连接，第一导线的另一端设置有第一插头，所述主机配置有适配所述第一插头的第一插孔，第一插头可插拔的连接第一插孔。通过第一插头与第一插孔的配合，可以方便的实现第一导线与主机的连接与分离，从而便于单独更换神经刺激针，以便实现神经刺激针的一次性使用。In order to solve the problem of one-time use of nerve stimulation needles, in Scheme 1, one end of the first wire is connected to the insulating needle handle, and the first wire is electrically connected to the conductive needle bar, and the other end of the first wire is provided with a first A plug, the host is configured with a first jack adapted to the first plug, and the first plug is pluggably connected to the first jack. Through the cooperation of the first plug and the first socket, the connection and separation of the first lead wire and the host can be conveniently realized, so that the nerve stimulation needle can be replaced separately, so as to realize the one-time use of the nerve stimulation needle.

方案二中，第一导线的一端连接有导电夹，所述绝缘针柄设置有适配导电夹的导电头，导电头与导电针杆电性连接。在使用时，当神经刺激针插入到位后，只需将导电夹夹持于导电头，即可实现第一导线与神经刺激针的连通，不仅使用方便，而且便于拆卸和更换。In the second solution, one end of the first wire is connected to a conductive clip, and the insulating needle handle is provided with a conductive head adapted to the conductive clip, and the conductive head is electrically connected to the conductive needle bar. When in use, after the nerve stimulation needle is inserted in place, only need to clamp the conductive clip to the conductive head to realize the communication between the first wire and the nerve stimulation needle, which is not only convenient to use, but also easy to disassemble and replace.

优选的，包括两个记录电极，两个记录电极分别通过两根第二导线连接主机。Preferably, it includes two recording electrodes, and the two recording electrodes are respectively connected to the host through two second wires.

为解决记录电极一次性使用的问题，进一步的，第二导线的一端连接于记录电极，第二导线的另一端设置有第二插头，所述主机配置有适配所述第二插头的第二插孔，第二插头可插拔的连接第二插孔。通过第二插头与第二插孔的配合，可以方便的实现第二导线与主机的连接与分离，从而便于单独更换记录电极和第二导线，以便实现记录电极的一次性使用。In order to solve the problem of one-time use of the recording electrode, further, one end of the second wire is connected to the recording electrode, the other end of the second wire is provided with a second plug, and the host is equipped with a second plug adapted to the second plug. jack, and the second plug is pluggably connected to the second jack. Through the cooperation of the second plug and the second jack, the connection and separation of the second wire and the host can be realized conveniently, so that the recording electrode and the second wire can be replaced separately, so as to realize the one-time use of the recording electrode.

为更好的采集肌电信号，进一步的，所述记录电极包括绝缘基层和设置于绝缘基层的导电片，导电片与第二导线相连，且导电片上背离绝缘基层的一侧设置有针尖。以便利用针尖插入患者的皮肤，既可以防止记录电极脱落，使得记录电极的设置更牢靠，又使得记录电极更加接近甲状软骨，从而更有利于采集肌电信号。In order to better collect electromyographic signals, further, the recording electrode includes an insulating base layer and a conductive sheet arranged on the insulating base layer, the conductive sheet is connected to the second wire, and a needle point is provided on the side of the conductive sheet away from the insulating base layer. In order to insert the needle tip into the patient's skin, it can prevent the recording electrode from falling off, make the setting of the recording electrode more reliable, and make the recording electrode closer to the thyroid cartilage, which is more conducive to collecting electromyographic signals.

进一步的，所述神经监测仪还包括报警器，所述报警器与主机相连，当所监测到的肌电信号低于所设定的阈值时，主机控制报警器报警。以便提醒医生。Further, the nerve monitor also includes an alarm connected to the host computer, and when the monitored myoelectric signal is lower than the set threshold, the host computer controls the alarm to give an alarm. to alert the doctor.

优选的，所述绝缘层为绝缘涂层。不仅可以实现绝缘的效果，而且可以尽量避免增加导电针杆的外径，使得导电针杆更小巧，更便于使用。Preferably, the insulating layer is an insulating coating. Not only can the effect of insulation be achieved, but also the outer diameter of the conductive needle bar can be avoided as much as possible, so that the conductive needle bar is smaller and more convenient to use.

进一步的，还包括接地电极，所述接地电极通过第三导线与主机相连。Further, a grounding electrode is also included, and the grounding electrode is connected to the host through a third wire.

进一步的，第三导线的一端连接于接地电极，第三导线的另一端设置有第三插头，所述主机配置有适配第三插头的第三插孔，第三插头可插拔的连接第三插孔。Further, one end of the third wire is connected to the ground electrode, the other end of the third wire is provided with a third plug, the host is equipped with a third jack adapted to the third plug, and the third plug is pluggably connected to the third plug. Three jacks.

本发明第二方面要进一步解决防止消融甲状腺肿瘤的过程中损伤喉返神经或迷走神经的问题，进一步的，还包括延长管，所述导电针杆构造有沿其轴线方向的通道，导电针尖的侧壁构造有开口，开口与通道相连通，The second aspect of the present invention is to further solve the problem of preventing damage to the recurrent laryngeal nerve or vagus nerve in the process of ablation of thyroid tumors. Further, it also includes an extension tube, the conductive needle rod is configured with a channel along its axis, and the side of the conductive needle tip The wall is constructed with openings which communicate with the channels,

延长管的一端连接于神经刺激针，并与所述通道相连通，另一端构造有适配注射器乳头的接口。在甲状腺肿瘤消融术中，神经刺激针的导电针尖可以插于靠近喉返神经或迷走神经的位置处，并位于甲状腺肿瘤与喉返神经或迷走神经之间，医生可以通过延长管向导电针尖所在的位置输注生理盐水，一方面，生理盐水的注入可以增加甲状腺肿瘤与喉返神经或迷走神经之间的间距，从而可以防止消融甲状腺肿瘤的过程中损伤喉返神经或迷走神经，尤其适用于甲状腺肿瘤与喉返神经或迷走神经之间很接近的场合；另一方面，生理盐水可以在甲状腺肿瘤与喉返神经或迷走神经之间形成阻隔，并具有降温的作用，可以有效防止甲状腺肿瘤消融过程中的热量损伤喉返神经或迷走神经。One end of the extension tube is connected to the nerve stimulation needle and communicates with the channel, and the other end is configured with an interface adapted to the nipple of the syringe. In thyroid tumor ablation, the conductive needle tip of the nerve stimulation needle can be inserted close to the recurrent laryngeal nerve or vagus nerve, and between the thyroid tumor and the recurrent laryngeal nerve or vagus nerve. Infusion of normal saline. On the one hand, the injection of normal saline can increase the distance between the thyroid tumor and the recurrent laryngeal nerve or vagus nerve, thereby preventing damage to the recurrent laryngeal nerve or vagus nerve during ablation of the thyroid tumor. When the recurrent nerve or vagus nerve is very close; on the other hand, normal saline can form a barrier between the thyroid tumor and the recurrent laryngeal nerve or vagus nerve, and has a cooling effect, which can effectively prevent the heat from damaging the larynx during ablation of thyroid tumors. recurrent or vagus nerve.

为解决反流的问题，进一步的，所述延长管还设置有用于控制通/断的开关，所述开关为医用夹闭器、医用单向阀或医用输液三通管。以便利用开关控制延长管的通/断，既可以防止所输注的生理盐水在内压的作用下反流出来，又可以维持所输注生理盐水的压力，以便更稳定的起到分隔神经与甲状腺肿瘤的作用。In order to solve the problem of reflux, further, the extension tube is also provided with a switch for controlling on/off, and the switch is a medical clamp, a medical one-way valve or a medical infusion three-way tube. In order to use the switch to control the on/off of the extension tube, it can not only prevent the infused saline from flowing back under the action of internal pressure, but also maintain the pressure of the infused saline, so as to more stably separate the nerve from the The role of thyroid tumors.

一种神经监测系统的使用方法，所述神经监测系统包括神经刺激针、记录电极以及神经监测仪，所述神经刺激针包括导电针杆和设置于导电针杆的绝缘针柄，导电针杆的一端设置有导电针尖，导电针杆的外表面设置有绝缘层；所述神经监测仪包括主机和显示屏，主机通过第一导线与神经刺激针相连，主机通过第二导线与记录电极相连，显示屏与主机通讯连接，所述使用方法包括，A method for using a nerve monitoring system, the nerve monitoring system comprising a nerve stimulation needle, a recording electrode and a nerve monitor, the nerve stimulation needle comprising a conductive needle rod and an insulating needle handle arranged on the conductive needle rod, the conductive needle rod One end is provided with a conductive needle tip, and the outer surface of the conductive needle rod is provided with an insulating layer; the neuromonitor includes a host and a display screen, the host is connected to the nerve stimulation needle through a first wire, and the host is connected to the recording electrode through a second wire, and the display The screen communicates with the host, and the method of use includes:

将神经刺激针的导电针尖插于喉返神经或迷走神经附近，并将记录电极贴于甲状软骨处的皮肤，Insert the conductive needle tip of the nerve stimulation needle near the recurrent laryngeal nerve or vagus nerve, and stick the recording electrode on the skin at the thyroid cartilage,

开启主机，利用主机向神经刺激针提供刺激信号，并使刺激信号经由导电针尖释放出去，Turn on the host, use the host to provide stimulation signals to the nerve stimulation needle, and release the stimulation signal through the conductive needle tip,

利用记录电极采集肌电信号，并将肌电信号传输给主机，Use the recording electrodes to collect myoelectric signals, and transmit the myoelectric signals to the host,

利用主机监测所述肌电信号，并将肌电信号以肌电图的形式显示于显示屏。从而在甲状腺肿瘤消融术中连续监测喉返神经或迷走神经是否受损，以防止出现神经持续损伤的问题，达到保护喉返神经和迷走神经的目的。The host computer is used to monitor the electromyographic signal, and the electromyographic signal is displayed on the display screen in the form of electromyogram. Therefore, whether the recurrent laryngeal nerve or vagus nerve is damaged is continuously monitored during ablation of thyroid tumors, so as to prevent continuous nerve damage and achieve the purpose of protecting the recurrent laryngeal nerve and vagus nerve.

在神经监测系统配置有接地电极的情况下，所述使用方法还包括将接地电极贴于患者上臂的皮肤。In the case where the neural monitoring system is configured with a ground electrode, the method of use further includes applying the ground electrode to the skin of the upper arm of the patient.

在神经监测系统配置有延长管的情况下，所述使用方法还包括通过延长管向导电针尖所在的位置输注生理盐水，利用所输注的生理盐水在导电针尖与喉返神经或迷走神经之间形成阻隔。可以进一步防止甲状腺肿瘤消融过程中的热量损伤喉返神经或迷走神经。In the case that the nerve monitoring system is configured with an extension tube, the method of use further includes infusing physiological saline to the position where the conductive needle tip is located through the extension tube, and using the infused physiological saline to connect between the conductive needle tip and the recurrent laryngeal nerve or vagus nerve form a barrier. It can further prevent the recurrent laryngeal nerve or vagus nerve from being damaged by heat during ablation of thyroid tumors.

与现有技术相比，使用本发明提供的一种适用于甲状腺肿瘤消融术的神经监测系统，可以与现有的消融系统以及超声系统配合使用，可以在消融术中实时监测喉返神经或迷走神经是否受损，使得在甲状腺肿瘤消融术中，医生可以通过本神经监测系统及时发现喉返神经或迷走神经是/否受损，从而可以有效防止在消融术中持续损伤神经，达到保护喉返神经和迷走神经的目的。Compared with the prior art, the nerve monitoring system suitable for thyroid tumor ablation provided by the present invention can be used in conjunction with the existing ablation system and ultrasound system, and can monitor the recurrent laryngeal nerve or vagus nerve in real time during ablation In the ablation of thyroid tumors, doctors can find out whether the recurrent laryngeal nerve or vagus nerve is damaged in time through the nerve monitoring system, so as to effectively prevent continuous nerve damage during ablation and protect the recurrent laryngeal nerve and vagus nerve. Purpose of the vagus nerve.

附图说明Description of drawings

为了更清楚地说明本发明实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本发明的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention, and thus It should be regarded as a limitation on the scope, and those skilled in the art can also obtain other related drawings based on these drawings without creative work.

图1为本发明实施例1提供的一种神经监测系统的示意图。FIG. 1 is a schematic diagram of a nerve monitoring system provided by Embodiment 1 of the present invention.

图2为人体颈部（喉部）的横截面示意图。FIG. 2 is a schematic cross-sectional view of the neck (larynx) of a human body.

图3为甲状腺肿瘤消融术中，神经监测系统中的神经刺激针、记录电极以及接地电极设置到位后的示意图。Fig. 3 is a schematic diagram of the neurostimulation needle, the recording electrode and the grounding electrode in the neuromonitoring system after the ablation of the thyroid tumor is in place.

图4为甲状腺肿瘤消融术中，消融系统与本神经监测系统配合使用时的示意图。Fig. 4 is a schematic diagram of the ablation system used in conjunction with the nerve monitoring system during the ablation of thyroid tumors.

图5为本发明实施例3提供的一种神经监测系统中，一种记录电极的侧视图。Fig. 5 is a side view of a recording electrode in a nerve monitoring system provided by Embodiment 3 of the present invention.

图6为本发明实施例4提供的一种神经监测系统的爆炸示意图。FIG. 6 is an exploded schematic diagram of a nerve monitoring system provided by Embodiment 4 of the present invention.

图7为本发明实施例5提供的一种神经监测系统中，一种神经刺激针的结构示意图。FIG. 7 is a schematic structural diagram of a nerve stimulation needle in a nerve monitoring system provided by Embodiment 5 of the present invention.

图8为本发明实施例5提供的一种神经监测系统中，导电夹夹持于神经刺激针的导电头后的示意图。8 is a schematic diagram of a conductive clip clamped behind a conductive head of a nerve stimulation needle in a nerve monitoring system provided by Embodiment 5 of the present invention.

图9为本发明实施例6提供的一种神经监测系统中，一种神经刺激针的结构示意图。Fig. 9 is a schematic structural diagram of a nerve stimulation needle in a nerve monitoring system provided by Embodiment 6 of the present invention.

图10为甲状腺肿瘤消融术中，利用注射器和神经刺激针向甲状腺与喉返神经之间的区域注射生理盐水后的示意图。Fig. 10 is a schematic diagram of injecting physiological saline into the area between the thyroid gland and the recurrent laryngeal nerve using a syringe and a nerve stimulating needle during ablation of thyroid tumors.

图中标记说明Marking description in the figure

神经刺激针100、导电针杆101、导电针尖102、绝缘针柄103、绝缘层104、第一导线105、第一插头106、导电夹107、凹槽108、导电头109、开口110、通道111、延长管112、接口113、内螺纹114、开关115Nerve stimulation needle 100,conductive needle shaft 101,conductive needle tip 102, insulatingneedle handle 103, insulatinglayer 104,first wire 105,first plug 106,conductive clip 107,groove 108,conductive head 109, opening 110,channel 111 ,extension tube 112,interface 113,internal thread 114,switch 115

记录电极200、绝缘基层201、导电片202、针尖203、第二导线204、第二插头205Recording electrode 200, insulatingbase layer 201,conductive sheet 202,needle point 203,second wire 204,second plug 205

接地电极300、第三导线301、第三插头302Ground electrode 300,third wire 301,third plug 302

主机401、显示屏402、接线板403、第一插孔404、第二插孔405、第三插孔406Host 401,display screen 402,wiring board 403,first jack 404,second jack 405,third jack 406

消融系统500、消融针501、消融主机502Ablation system 500,ablation needle 501,ablation host 502

超声探头600Ultrasound probe 600

注射器700、乳头701Syringe 700,nipple 701

甲状腺801、甲状腺肿瘤802、喉返神经803、迷走神经804、气管805、食管806、颈总动脉807、颈内静脉808、皮肤809、生理盐水810、上臂811。Thyroid 801,thyroid tumor 802, recurrentlaryngeal nerve 803,vagus nerve 804,trachea 805,esophagus 806, commoncarotid artery 807, internaljugular vein 808,skin 809,normal saline 810,upper arm 811.

具体实施方式detailed description

下面将结合本发明实施例中附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。因此，以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. The components of the embodiments of the invention generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations. Accordingly, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without making creative efforts belong to the protection scope of the present invention.

实施例1Example 1

本实施例中首先提供了一种神经监测系统，包括神经刺激针100、记录电极200以及神经监测仪，其中，In this embodiment, a nerve monitoring system is firstly provided, including anerve stimulation needle 100, arecording electrode 200, and a nerve monitor, wherein,

神经刺激针100主要用于施加刺激信号，在实施时，神经刺激针100包括导电针杆101和设置于导电针杆101的绝缘针柄103，如图1所示，导电针杆101可以优先采用圆柱杆，导电针杆101的一端设置有导电针尖102，且导电针杆101的外表面设置有绝缘层104，只需将导电针尖102暴露在外即可，以便释放刺激信号。在实施时，绝缘层104可以采用绝缘涂层，不仅可以实现绝缘的效果，而且可以尽量避免增加导电针杆101的外径，使得导电针杆101更小巧，更便于使用；绝缘涂层可以是利用现有的绝缘涂料（或绝缘漆）涂覆在导电针杆101的外表面而形成的。当然，在实施时，绝缘层104也可以是套设于导电针杆101外的绝缘套筒，也能达到绝缘的目的。Nerve stimulation needle 100 is mainly used to apply stimulation signals. During implementation,nerve stimulation needle 100 includesconductive needle shaft 101 and insulating needle handle 103 arranged onconductive needle shaft 101. As shown in FIG. 1,conductive needle shaft 101 can be preferably used One end of theconductive needle rod 101 is provided with aconductive needle point 102, and the outer surface of theconductive needle rod 101 is provided with an insulatinglayer 104. It is only necessary to expose theconductive needle point 102 to release the stimulation signal. During implementation, the insulatinglayer 104 can adopt an insulating coating, which can not only achieve the effect of insulation, but also avoid increasing the outer diameter of theconductive needle bar 101, making theconductive needle bar 101 smaller and more convenient to use; the insulating coating can be It is formed by coating the outer surface of theconductive needle bar 101 with existing insulating paint (or insulating varnish). Of course, during implementation, the insulatinglayer 104 can also be an insulating sleeve sheathed on the outside of theconductive needle bar 101, which can also achieve the purpose of insulation.

在本实施例中，神经监测仪可以采用现有的神经监测仪，现有的神经监测仪通常包括主机401和显示屏402，如图1所示，显示屏402与主机401通讯连接，以便相互通讯，主机401通过第一导线105与神经刺激针100相连，具体而言，第一导线105与神经刺激针100的导电针杆101电连接，主机401主要用于提供刺激信号，使得刺激信号可以经由第一导线105传递到神经刺激针100的导电针尖102，并最终从导电针尖102释放出去。在实施时，显示屏402与主机401可以相互分离设置，二者通过导线相连即可，另外，显示屏402也可以直接构造于主机401，使得显示屏402与主机401相连为一体。可以理解，主机401内通常还配置有处理器、刺激信号发生模块、储存模块、电源模块等，处理器分别与刺激信号发生模块、储存模块以及电源模块电连接，刺激信号发生模块用于在控制器的控制下产生刺激信号，第一导线105与刺激信号发生模块相连，以便传输刺激信号。In this embodiment, the neuromonitor can adopt an existing neuromonitor, and the existing neuromonitor generally includes ahost 401 and adisplay screen 402. As shown in FIG. Communication, thehost 401 is connected to thenerve stimulation needle 100 through thefirst wire 105, specifically, thefirst wire 105 is electrically connected to theconductive needle bar 101 of thenerve stimulation needle 100, and thehost 401 is mainly used to provide stimulation signals, so that the stimulation signals can be It is delivered to theconductive needle tip 102 of thenerve stimulation needle 100 via thefirst wire 105 and finally released from theconductive needle tip 102 . During implementation, thedisplay screen 402 and thehost 401 can be separated from each other, and the two can be connected by wires. In addition, thedisplay screen 402 can also be directly constructed on thehost 401, so that thedisplay screen 402 and thehost 401 are connected as one. It can be understood that thehost 401 is usually equipped with a processor, a stimulus signal generating module, a storage module, a power supply module, etc., and the processor is electrically connected to the stimulus signal generating module, the storage module, and the power supply module respectively, and the stimulus signal generating module is used for controlling The stimulation signal is generated under the control of the device, and thefirst wire 105 is connected with the stimulation signal generating module so as to transmit the stimulation signal.

在使用时，记录电极200可以贴于患者的甲状软骨处的皮肤，主要用于采集肌电信号，如记录电极200可以采集患者的喉肌电信号，主机401可以通过第二导线204与记录电极200相连，以便将所采集的肌电信号传输到主机401中。例如，第二导线204可以与主机401中的处理器电连接，以便利用处理器提取、分析和储存所采集的肌电信号，实现监测肌电信号的目的，主机401还可以将所接收到的肌电信号形成肌电图（EMG），显示屏402可以与主机401中的处理器通讯连接，使得显示屏402至少可以与显示由肌电信号所构成的肌电图。When in use, therecording electrode 200 can be attached to the skin of the patient's thyroid cartilage, and is mainly used to collect myoelectric signals. For example, therecording electrode 200 can collect the patient's laryngeal myoelectric signal, and thehost 401 can communicate with the recording electrode through thesecond wire 204. 200 so as to transmit the collected EMG signal to thehost 401. For example, thesecond wire 204 can be electrically connected to the processor in thehost computer 401, so that the processor can be used to extract, analyze and store the collected electromyographic signals to realize the purpose of monitoring the electromyographic signals, and thehost computer 401 can also send the received The myoelectric signal forms an electromyogram (EMG), and thedisplay screen 402 can communicate with the processor in thehost 401, so that thedisplay screen 402 can at least display the EMG formed by the electromyographic signal.

在本实施例中，记录电极200可以采用现有的电极片，例如，记录电极200包括绝缘基层201和设置于绝缘基层201的导电片202，导电片202与第二导线204相连，绝缘基层201可以采用无纺布等绝缘材料制成。In this embodiment, therecording electrode 200 can be an existing electrode sheet. For example, therecording electrode 200 includes an insulatingbase layer 201 and aconductive sheet 202 arranged on the insulatingbase layer 201. Theconductive sheet 202 is connected to thesecond wire 204. The insulatingbase layer 201 It can be made of insulating materials such as non-woven fabrics.

在实施时，记录电极200的数目可以是一个、两个或多个，如图1所示，本神经监测系统可以包括两个记录电极200，两个记录电极200分别通过两根第二导线204连接主机401。During implementation, the number ofrecording electrodes 200 can be one, two or more. As shown in FIG.Connect host 401.

在更完善的方案中，本神经监测系统还包括接地电极300，如图1所示，接地电极300可以通过第三导线301与主机401相连，以便实现接地功能。接地电极300的数目可以适配记录电极200的数目，在使用时，接地电极300可以设置于患者上臂811的皮肤。In a more perfect solution, the nerve monitoring system further includes agrounding electrode 300 , as shown in FIG. 1 , thegrounding electrode 300 can be connected to thehost 401 through athird wire 301 to realize the grounding function. The number ofground electrodes 300 can match the number ofrecording electrodes 200 , and when in use, theground electrodes 300 can be placed on the skin of the patient'supper arm 811 .

在本实施例中，绝缘针柄103主要便于使用者握持，绝缘针柄103的设置位置可以根据实际需求而定，例如，绝缘针柄103可以设置于导电针杆101的另一端，如图1所示，而所述第一导线105的一端可以连接于该绝缘针柄103，且第一导线105与导电针杆101电性连接。由于根据人体颈部处的生理结构，如图2所示，迷走神经804位于更靠近患者体表的位置处，而喉返神经803位于远离患者体表的位置处；在本实施例中，导电针尖102与绝缘针柄103之间的间距可以大于或等于8厘米，使得神经刺激针100的导电针尖102可以插入到喉返神经803的附近处，以便监测喉返神经803是否损伤。在优选的实施方式中，导电针尖102与绝缘针柄103之间的间距可以是8～20厘米，在本实施例中，导电针尖102与绝缘针柄103之间的间距为10厘米。而为便于控制神经刺激针100的插入深度，导电针杆101的表面还设置有刻度线，刻度线沿导电针杆101的长度方向设置。在本实施例中，导电针杆101的直径可以为1.5mm～2.0mm。In this embodiment, the insulatingneedle handle 103 is mainly convenient for the user to hold, and the setting position of the insulating needle handle 103 can be determined according to actual needs. For example, the insulating needle handle 103 can be arranged at the other end of theconductive needle rod 101, as shown 1, and one end of thefirst wire 105 can be connected to the insulatingneedle handle 103, and thefirst wire 105 is electrically connected to theconductive needle bar 101. According to the physiological structure at the neck of the human body, as shown in Figure 2, thevagus nerve 804 is located closer to the patient's body surface, while the recurrentlaryngeal nerve 803 is located farther away from the patient's body surface; in this embodiment, the conductive needle tip The distance between 102 and insulating needle handle 103 can be greater than or equal to 8 cm, so that theconductive needle tip 102 ofnerve stimulation needle 100 can be inserted near the recurrentlaryngeal nerve 803 to monitor whether the recurrentlaryngeal nerve 803 is damaged. In a preferred embodiment, the distance between theconductive needle tip 102 and the insulating needle handle 103 may be 8-20 cm. In this embodiment, the distance between theconductive needle tip 102 and the insulatingneedle handle 103 is 10 cm. In order to facilitate the control of the insertion depth of thenerve stimulation needle 100 , a scale line is provided on the surface of theconductive needle bar 101 , and the scale line is arranged along the length direction of theconductive needle bar 101 . In this embodiment, the diameter of theconductive needle shaft 101 may be 1.5mm˜2.0mm.

本神经监测系统可以与现有的消融系统500以及医用超声成像系统配合使用，为便于说明，现有的消融系统500包括消融针501和消融主机502，消融针501通过导线与消融主机502相连，消融主机502用于为热消融过程提供能量，消融针501用于释放消融能量。现有的医用超声成像系统是利用超声波照射人体，通过接收和处理裁有人体组织或结构性质特征信息的回波，获得人体组织性质与结构的可见图像的方法和技术，在医疗领域应用广泛；现有的医用超声成像系统通常包括超声探头600、与超声探头600相连的数据处理端以及连接于数据处理端的显示器，超声探头600主要用于发射和接收超声波，显示器可以显示所成的影像，达到可视的目的。作为一种典型的使用方法，如图2所示是某患者喉部的剖视图，在进行甲状腺肿瘤802消融术前，医生可以利用超声成像系统查看甲状腺肿瘤802、喉返神经803以及迷走神经804等的位置，如图2所示，甲状腺肿瘤802位于靠近喉返神经803的位置处；然后，医生可以在超声的引导下将神经刺激针100的导电针尖102插入到靠近喉返神经803的位置处，使得导电针尖102位于喉返神经803与甲状腺肿瘤802之间，如图3所示；然后，医生可以将两个记录电极200分别贴在患者的左右两个甲状软骨处的皮肤处，如图3所示，并将接地电极300贴在患者上臂811的皮肤处；然后，开启神经监测仪，神经监测仪连续输出或间歇性的输出刺激信号，刺激信号经由神经刺激针100的导电针尖102输出，刺激附近的喉返神经803，从而能激发神经电位，使得喉肌发生收缩，引发声带振动，从而产生肌电信号，此肌电信号可以被记录电极200接收，并传回神经监测仪，经神经监测仪的滤波、放大等处理后即可在显示屏402中显示出肌电图。然后，医生可以在超声的引导下，将消融系统500中的消融针501插进甲状腺肿瘤802内 (或消融区域内)，如图4所示，消融主机502启动，使得消融针501尖附近温度达到60℃以上，以便利用热量使得肿瘤消融，达到治疗的目的。在这个过程中，本神经监测系统可以不断采集和显示肌电图，以便实现实时监测，使得医生可以在整个消融术中，通过显示屏402实时查看肌电图的变化情况，一旦发现肌电图中的肌电信号低于所设定的阈值，则表明喉返神经803受损，此时，医生可以及时关闭或调整消融系统500，以防止消融针501持续损伤喉返神经803，达到保护喉返神经803的目的。The nerve monitoring system can be used in conjunction with the existingablation system 500 and medical ultrasound imaging system. For the convenience of illustration, the existingablation system 500 includes anablation needle 501 and anablation host 502. Theablation needle 501 is connected to theablation host 502 through wires. Theablation host 502 is used to provide energy for the thermal ablation process, and theablation needle 501 is used to release ablation energy. The existing medical ultrasound imaging system is a method and technology that uses ultrasonic waves to irradiate the human body, and obtains visible images of the properties and structures of human tissue by receiving and processing echoes that contain characteristic information of human tissue or structure properties, and is widely used in the medical field; Existing medical ultrasound imaging systems generally include anultrasound probe 600, a data processing terminal connected to theultrasound probe 600, and a display connected to the data processing terminal. Theultrasound probe 600 is mainly used to transmit and receive ultrasound waves, and the display can display the formed image, achieving visual purpose. As a typical application method, as shown in Fig. 2 is a cross-sectional view of a patient's larynx. Before ablation ofthyroid tumor 802, the doctor can use the ultrasound imaging system to check thethyroid tumor 802, recurrentlaryngeal nerve 803, andvagus nerve 804. location, as shown in Figure 2, thethyroid tumor 802 is located near the recurrentlaryngeal nerve 803; then, under the guidance of ultrasound, the doctor can insert theconductive needle tip 102 of thenerve stimulation needle 100 into the position near the recurrentlaryngeal nerve 803, Make theconductive needle point 102 be located between the recurrentlaryngeal nerve 803 and thethyroid tumor 802, as shown in Figure 3; then, the doctor can stick tworecording electrodes 200 on the skin of the left and right thyroid cartilages of the patient, as shown in Figure 3 As shown, and stick thegrounding electrode 300 on the skin of theupper arm 811 of the patient; then, turn on the nerve monitor, and the nerve monitor continuously outputs or intermittently outputs stimulation signals, and the stimulation signals are output through theconductive needle tip 102 of thenerve stimulation needle 100, Stimulate the nearby recurrentlaryngeal nerve 803, thereby stimulating the nerve potential, causing the laryngeal muscle to contract, causing the vocal cords to vibrate, thereby generating myoelectric signals, which can be received by therecording electrodes 200 and transmitted back to the nerve monitor. The electromyogram can be displayed on thedisplay screen 402 after filtering, amplifying and other processing of the monitor. Then, the doctor can insert theablation needle 501 in theablation system 500 into the thyroid tumor 802 (or the ablation area) under the guidance of ultrasound. As shown in FIG. Reach above 60°C, in order to use heat to ablate the tumor and achieve the purpose of treatment. During this process, the nerve monitoring system can continuously collect and display the electromyogram to realize real-time monitoring, so that the doctor can check the changes of the electromyogram in real time through thedisplay screen 402 during the entire ablation operation. If the EMG signal in is lower than the set threshold value, it indicates that the recurrentlaryngeal nerve 803 is damaged. At this time, the doctor can turn off or adjust theablation system 500 in time to prevent theablation needle 501 from continuously damaging the recurrentlaryngeal nerve 803 and protect the laryngeal nerve. Purpose ofrecurrent nerve 803 .

实施例2Example 2

本实施例2与上述实施例的主要区别在于，本实施例所提供的神经监测系统中，神经监测仪还包括报警器，所述报警器与主机401相连，当所监测到的肌电信号低于所设定的阈值时，主机401控制报警器报警。更具地，报警器可以与主机401内的处理器相连，当处理器监测到肌电信号低于所设定的阈值时，表明喉返神经803或迷走神经804受损，此时，处理器可以控制报警器报警，以便提醒医生。The main difference between this embodiment 2 and the above-mentioned embodiments is that in the nerve monitoring system provided by this embodiment, the nerve monitor also includes an alarm, and the alarm is connected to thehost 401. When the monitored myoelectric signal is lower than When the threshold is set, thehost 401 controls the alarm to alarm. More specifically, the alarm can be connected to the processor in thehost computer 401. When the processor detects that the EMG signal is lower than the set threshold, it indicates that the recurrentlaryngeal nerve 803 or thevagus nerve 804 is damaged. At this time, the processor can Control the alarm to alarm, so as to remind the doctor.

实施例3Example 3

本实施例3与上述实施例的主要区别在于，本实施例所提供的神经监测系统中，记录电极200中，导电片202上背离绝缘基层201的一侧设置有针尖203，如图5所示，以便利用针尖203插入患者的皮肤，针尖203可导电，针尖203的材质可以与导电片202相同，既可以防止记录电极200脱落，使得记录电极200的设置更牢靠，又使得记录电极200更加接近甲状软骨，从而更有利于采集肌电信号。The main difference between this embodiment 3 and the above-mentioned embodiments is that in the nerve monitoring system provided by this embodiment, in therecording electrode 200, aneedle tip 203 is provided on the side of theconductive sheet 202 away from the insulatingbase layer 201, as shown in FIG. 5 , so that theneedle point 203 can be inserted into the patient's skin, theneedle point 203 can conduct electricity, and the material of theneedle point 203 can be the same as that of theconductive sheet 202, which can prevent therecording electrode 200 from falling off, make the setting of therecording electrode 200 more reliable, and make therecording electrode 200 closer Thyroid cartilage, which is more conducive to the acquisition of EMG signals.

实施例4Example 4

为便于一次性使用，本实施例4与上述实施例的主要区别在于，本实施例所提供的神经监测系统中，第一导线105的一端连接于绝缘针柄103，且第一导线105与导电针杆101电性连接，而第一导线105的另一端设置有第一插头106，如图6所示，同时，主机401配置有适配第一插头106的第一插孔404，第一插头106可插拔的连接第一插孔404，在实际使用时，通过第一插头106与第一插孔404的配合，可以方便的实现第一导线105与主机401的连接与分离，从而便于单独更换神经刺激针100，以便实现神经刺激针100的一次性使用。For the convenience of one-time use, the main difference between this embodiment 4 and the above-mentioned embodiments is that in the nerve monitoring system provided by this embodiment, one end of thefirst wire 105 is connected to the insulatingneedle handle 103, and thefirst wire 105 is connected to the conductive Theneedle bar 101 is electrically connected, and the other end of thefirst wire 105 is provided with afirst plug 106, as shown in FIG. 106 is pluggably connected to thefirst jack 404. In actual use, through the cooperation of thefirst plug 106 and thefirst jack 404, the connection and separation of thefirst wire 105 and thehost 401 can be easily realized, so that it is convenient to separate Thenerve stimulation needle 100 is replaced so that thenerve stimulation needle 100 is disposable.

同理，第二导线204的一端连接于记录电极200，第二导线204的另一端设置有第二插头205，同时，主机401配置有适配第二插头205的第二插孔405，第二插头205可插拔的连接第二插孔405，使得在实际使用时，通过第二插头205与第二插孔405的配合，可以方便的实现第二导线204与主机401的连接与分离，从而便于单独更换记录电极200和第二导线204，以便实现记录电极200的一次性使用。Similarly, one end of thesecond wire 204 is connected to therecording electrode 200, and the other end of thesecond wire 204 is provided with asecond plug 205. At the same time, thehost 401 is equipped with asecond jack 405 adapted to thesecond plug 205. Theplug 205 is pluggably connected to thesecond jack 405, so that in actual use, through the cooperation of thesecond plug 205 and thesecond jack 405, the connection and separation of thesecond wire 204 and thehost 401 can be easily realized, thereby It is convenient to replace therecording electrode 200 and thesecond wire 204 separately, so as to realize the one-time use of therecording electrode 200 .

同理，第三导线301的一端连接于接地电极300，另一端设置有第三插头302，同时，主机401配置有适配第三插头302的第三插孔406，第三插头302可插拔的连接第三插孔406，使得在实际使用时，通过第三插头302与第三插孔406的配合，可以方便的实现第三导线301与主机401的连接与分离，以便实现接地电极300的一次性使用。Similarly, one end of thethird wire 301 is connected to theground electrode 300, and the other end is provided with athird plug 302. Meanwhile, thehost 401 is equipped with athird socket 406 adapted to thethird plug 302, and thethird plug 302 is pluggable. connected to thethird jack 406, so that in actual use, through the cooperation of thethird plug 302 and thethird jack 406, the connection and separation of thethird wire 301 and thehost 401 can be easily realized, so as to realize the connection of theground electrode 300 Single use.

在实施时，第一插孔404、第二插孔405以及第三插孔406可以直接构造于主机401，也可以构造于一个单独的接线板403，例如，如图6所示，第一插孔404、第二插孔405以及第三插孔406分别构造于接线板403，接线板403的第一插孔404、第二插孔405以及第三插孔406可以分别通过导线与主机401相连，在使用时，只需将第一插头106、第二插头205以及第三插头302分别插入对应的第一插孔404、第二插孔405以及第三插孔406即可实现第一导线105、第二导线204、第三导线301与主机401的连通，非常的方便，此时，神经监测仪中的主机401可以采用现有NIM 3.0神经监护仪中的主机401，所述接线板403可以采用现有NIM 3.0神经监护仪中的接线板403。During implementation, thefirst jack 404, thesecond jack 405, and thethird jack 406 can be directly configured on thehost 401, or can be configured on aseparate wiring board 403. For example, as shown in FIG. 6, the first jack Thehole 404, thesecond jack 405 and thethird jack 406 are respectively configured in thewiring board 403, and thefirst jack 404, thesecond jack 405 and thethird jack 406 of thewiring board 403 can be connected to thehost computer 401 through wires respectively. , when in use, only need to insert thefirst plug 106, thesecond plug 205 and thethird plug 302 into the correspondingfirst socket 404, thesecond socket 405 and thethird socket 406 respectively to realize thefirst wire 105 , the communication between thesecond wire 204, thethird wire 301 and thehost 401 is very convenient, at this time, thehost 401 in the nerve monitor can adopt thehost 401 in the existing NIM 3.0 nerve monitor, and theterminal block 403 can Thewiring board 403 in the existing NIM 3.0 nerve monitor is adopted.

实施例5Example 5

为便于一次性使用，本实施例5与上述实施例的主要区别在于，本实施例所提供的神经监测系统中，第一导线105的一端连接有导电夹107，另一端可以直接连接于主机401，也可以设置第一插头106，通过第一插头106与第一插孔404的配合连通主机401；所述绝缘针柄103设置有适配导电夹107的导电头109，导电头109与导电针杆101电性连接。在使用时，当神经刺激针100插入到位后，只需将导电夹107夹持于导电头109，即可实现第一导线105与神经刺激针100的连通，不仅使用方便，而且便于拆卸和更换。For the convenience of one-time use, the main difference between this embodiment 5 and the above-mentioned embodiments is that in the nerve monitoring system provided by this embodiment, one end of thefirst wire 105 is connected to aconductive clip 107, and the other end can be directly connected to thehost 401 , thefirst plug 106 can also be set, and thehost 401 can be connected through the cooperation between thefirst plug 106 and thefirst jack 404; Therod 101 is electrically connected. In use, when thenerve stimulation needle 100 is inserted in place, only theconductive clip 107 is clamped on theconductive head 109 to realize the connection between thefirst wire 105 and thenerve stimulation needle 100, which is not only convenient to use, but also easy to disassemble and replace .

导电头109具有多种实施方式，例如，导电头109可以是设置于绝缘针柄103的导电耳片，导电耳片为片状结构，导电夹107的夹持口可以构造为平齐，以便夹持导电耳片。又如，如图7所示，导电针杆101的一端可以延伸出绝缘针柄103并形成所述导电头109，即，导电头109与绝缘针柄103为一体结构，且导电头109为圆柱形，此时，导电夹107的夹持口内构造有凹槽108，如图7及图8所示，以便适配导电头109，从而可以稳定的夹持导电头109。Theconductive head 109 has multiple implementations. For example, theconductive head 109 can be a conductive lug arranged on the insulatingneedle handle 103, the conductive lug is a sheet structure, and the clamping opening of theconductive clip 107 can be configured to be flush, so that the clamping Hold conductive tabs. As another example, as shown in Figure 7, one end of theconductive needle bar 101 can extend out of the insulatingneedle handle 103 and form theconductive head 109, that is, theconductive head 109 and the insulating needle handle 103 are integrally structured, and theconductive head 109 is a cylinder At this time, agroove 108 is formed in the clamping mouth of theconductive clip 107, as shown in FIG. 7 and FIG.

采用这样的方式，在每次使用时，只需更换神经刺激针100即可，更有利于节约成本。In this manner, only thenerve stimulation needle 100 needs to be replaced each time it is used, which is more conducive to saving costs.

实施例6Example 6

为防止消融甲状腺肿瘤802的过程中损伤喉返神经803或迷走神经804，本实施例6与上述实施例的主要区别在于，本实施例所提供的神经监测系统，还包括延长管112，延长管112可以优先采用软管，同时，所述导电针杆101构造有沿其轴线方向的通道111，如图9及图10所示，导电针尖102的侧壁构造有开口110，开口110与通道111相连通，延长管112的一端连接于神经刺激针100，并与所述通道111相连通，例如，通道111贯穿导电针杆101背离导电针尖102的一端，延长管112的一端可以连接于神经刺激针100的绝缘针柄103，并与通道111相连通，如图9所示，延长管112的另一端构造有适配注射器700乳头的接口113。在甲状腺肿瘤802消融术中，神经刺激针100的导电针尖102可以插于靠近喉返神经803或迷走神经804的位置处，并位于甲状腺801与喉返神经803或迷走神经804之间，如图10所示，医生可以通过延长管112向导电针尖102所在的位置输注生理盐水810，如图10所示，一方面，生理盐水的注入可以增加甲状腺肿瘤802与喉返神经803或迷走神经804之间的间距，从而可以防止消融甲状腺肿瘤802的过程中损伤喉返神经803或迷走神经804，尤其适用于甲状腺肿瘤802与喉返神经803或迷走神经804之间很接近的场合；另一方面，生理盐水810可以在甲状腺肿瘤802与喉返神经803或迷走神经804之间形成阻隔，如图10所示，并具有降温的作用，可以有效防止甲状腺肿瘤802消融过程中的热量损伤喉返神经803或迷走神经804。In order to prevent damage to the recurrentlaryngeal nerve 803 orvagus nerve 804 during ablation of thethyroid tumor 802, the main difference between this embodiment 6 and the above embodiment is that the nerve monitoring system provided by this embodiment also includes anextension tube 112, an extension tube 112 A hose can be preferably used. At the same time, theconductive needle bar 101 is configured with achannel 111 along its axis. As shown in FIGS. One end of theextension tube 112 is connected to thenerve stimulation needle 100 and communicates with thechannel 111. For example, thechannel 111 runs through the end of theconductive needle rod 101 away from theconductive needle tip 102, and one end of theextension tube 112 can be connected to the nerve stimulation needle. The insulated needle handle 103 of 100 communicates with thechannel 111, as shown in FIG. During the ablation ofthyroid tumor 802, theconductive needle tip 102 of thenerve stimulating needle 100 can be inserted at a position close to the recurrentlaryngeal nerve 803 or thevagus nerve 804, and between thethyroid gland 801 and the recurrentlaryngeal nerve 803 or thevagus nerve 804, as shown in FIG. 10 As shown, the doctor can infusenormal saline 810 to the position where theconductive needle tip 102 is located through theextension tube 112, as shown in FIG. distance between the recurrentlaryngeal nerve 803 and thevagus nerve 804 during ablation of thethyroid tumor 802, which is especially suitable for situations where thethyroid tumor 802 is very close to the recurrentlaryngeal nerve 803 or thevagus nerve 804; on the other hand,normal saline 810 can A barrier is formed between thethyroid tumor 802 and the recurrentlaryngeal nerve 803 orvagus nerve 804, as shown in FIG.

在实施时，所述接口113可以是构造有内螺纹114的螺纹接口113，如图9所示，以便适配具有外螺纹的注射器700乳头；所述接口113也可以是锥形孔或圆孔，以便适配没有设置外螺纹的注射器700乳头。In practice, theinterface 113 can be a threadedinterface 113 configured with aninternal thread 114, as shown in Figure 9, so as to fit the nipple of asyringe 700 with an external thread; , so as to adapt to the nipple of thesyringe 700 that is not provided with external thread.

而为防止生理盐水反流出来，在进一步的方案中，所述延长管112还设置有用于控制通/断的开关115，以便利用开关115控制延长管112的通/断，既可以防止所输注的生理盐水在内压的作用下反流出来，又可以维持所输注生理盐水的压力，以便更稳定的起到分隔神经与甲状腺肿瘤802的作用。在实施时，所述开关115可以现有技术中常用的医用夹闭器、医用单向阀或医用输液三通管等，如图9及图10所示，以便在完成注射后，利用开关115关闭延长管112。In order to prevent physiological saline from flowing back, in a further solution, theextension tube 112 is also provided with aswitch 115 for controlling on/off, so that theswitch 115 is used to control the on/off of theextension tube 112, which can prevent the infusion The injected saline flows back out under the action of internal pressure, and can maintain the pressure of the infused saline, so as to more stably play the role of separating the nerve and thethyroid tumor 802 . In practice, theswitch 115 can be a medical clamp commonly used in the prior art, a medical one-way valve or a medical infusion tee, etc., as shown in Figures 9 and 10, so that after the injection is completed, theswitch 115 can be used to Theextension tube 112 is closed.

不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。It is not limited thereto, and anyone skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present invention, which should be covered by the protection scope of the present invention.

Claims (10)

1. A nerve monitoring system suitable for thyroid tumor ablation is characterized by comprising a nerve stimulation needle for applying stimulation signals, wherein the nerve stimulation needle comprises a conductive needle rod and an insulating needle handle arranged on the conductive needle rod, one end of the conductive needle rod is provided with a conductive needle point, and the outer surface of the conductive needle rod is provided with an insulating layer;

the recording electrode is attached to the skin at the thyroid cartilage and used for collecting myoelectric signals; and

the nerve monitor comprises a host and a display screen, wherein the host is connected with a nerve stimulating needle through a first lead and used for providing a stimulating signal, the host is connected with a recording electrode through a second lead and used for monitoring an electromyogram signal, and the display screen is in communication connection with the host and at least used for displaying an electromyogram formed by the electromyogram signal.

2. The nerve monitoring system suitable for thyroid tumor ablation according to claim 1, wherein the distance between the conductive needle tip and the insulating needle handle is greater than or equal to 8 cm.

3. The nerve monitoring system suitable for thyroid tumor ablation according to claim 2, wherein the distance between the conductive needle tip and the insulating needle handle is 10 cm.

4. The nerve monitoring system suitable for thyroid tumor ablation according to claim 1, wherein one end of the first conducting wire is connected to the insulating needle handle, the first conducting wire is electrically connected with the conductive needle rod, a first plug is arranged at the other end of the first conducting wire, the host is provided with a first jack adapted to the first plug, and the first plug is connected with the first jack in a pluggable manner;

or the like, or, alternatively,

one end of the first lead is connected with a conductive clamp, the insulating needle handle is provided with a conductive head matched with the conductive clamp, and the conductive head is electrically connected with the conductive needle rod.

5. The nerve monitoring system suitable for thyroid tumor ablation according to claim 1, wherein one end of the second wire is connected to the recording electrode, the other end of the second wire is provided with a second plug, the host is configured with a second jack adapted to the second plug, and the second plug is connected with the second jack in a pluggable manner.

6. The nerve monitoring system suitable for thyroid tumor ablation according to claim 1, further comprising a ground electrode, wherein the ground electrode is connected to the host computer through a third wire.

7. The nerve monitoring system suitable for thyroid tumor ablation according to claim 6, wherein one end of the third wire is connected to the ground electrode, the other end of the third wire is provided with a third plug, and the host computer is provided with a third jack adapted to the third plug, and the third plug is connected to the third jack in a pluggable manner.

8. The nerve monitoring system suitable for thyroid tumor ablation according to any one of claims 1 to 7, wherein the recording electrode comprises an insulating base layer and a conducting strip disposed on the insulating base layer, the conducting strip is connected to the second conducting wire, and a needle point is disposed on a side of the conducting strip away from the insulating base layer,

and/or the nerve monitor also comprises an alarm which is connected with the host, and when the monitored electromyographic signals are lower than the set threshold value, the host controls the alarm to give an alarm.

9. The nerve monitoring system suitable for thyroid tumor ablation according to any one of claims 1 to 7, further comprising an elongated tube, wherein the conductive needle shaft is configured with a passage along its axis, the side wall of the conductive needle tip is configured with an opening, the opening is communicated with the passage,

one end of the extension tube is connected with the nerve stimulation needle and communicated with the channel, and the other end of the extension tube is provided with a connector matched with the nipple of the injector.

10. A method of using the nerve monitoring system of any one of claims 1-9, comprising,

inserting the conductive needle tip of the nerve stimulating needle near recurrent laryngeal nerve or vagus nerve, attaching the recording electrode to the skin at the thyroid cartilage,

the host is started, the host is utilized to provide a stimulation signal to the nerve stimulation needle, the stimulation signal is released out through the conductive needle tip,

the recording electrode is used for collecting the electromyographic signal and transmitting the electromyographic signal to the host,

and monitoring the electromyographic signals by using a host, and displaying the electromyographic signals on a display screen in an electromyogram manner.

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