CN109330591B - Evoked potential monitor for real-time monitoring of cavernous nerve injury during laparoscopic surgery - Google Patents
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Abstract
Description
技术领域technical field
本发明属于医疗器械技术领域，特别涉及腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪。The invention belongs to the technical field of medical devices, and particularly relates to an evoked potential instrument for real-time monitoring of penile cavernous nerve damage during laparoscopy.
背景技术Background technique
盆腔手术如前列腺癌根治术、根治性膀胱全切除术等常会损伤阴茎海绵体神经(cavernous nerve, CN)，术后阴茎勃起功能障碍（erectile dysfunction, ED）发生率可达25-90%，严重影响患者的生活质量。虽然Walsh、Donker等学者设计了保留双侧CN的前列腺癌根治术，并取得一定效果，但是其术后仍然有14-69%的患者出现不同程度的ED。而随着前列腺癌、膀胱癌发病率的日趋年轻化，患者对术后的勃起功能有更高的要求，通常需要术中保留CN。Pelvic surgery such as radical prostatectomy, radical cystectomy, etc. often damage the cavernous nerve (CN) of the penis, and the incidence of erectile dysfunction (ED) after surgery can reach 25-90%. affect the patient's quality of life. Although Walsh, Donker and other scholars have designed radical prostatectomy with preservation of bilateral CN, and achieved certain results, 14-69% of patients still have ED of varying degrees after surgery. With the increasing incidence of prostate cancer and bladder cancer, patients have higher requirements for erectile function after surgery, and usually need to retain CN during surgery.
术中CN保留困难的原因主要有：①CN解剖位置的多变性，解剖学研究表明只有52%的男性有正常清晰的CN走行；②CN上覆盖结缔组织，分离困难；③出血导致术野模糊；④由于体位原因导致CN暴露不佳。现阶段术中定位CN的方法主要有两种：The main reasons for the difficulty in preserving CN during surgery are: (1) The anatomical position of CN is variable, and anatomical studies show that only 52% of men have a normal and clear CN course; (2) The CN is covered with connective tissue, which is difficult to separate; (3) Bleeding leads to blurred surgical field; (4) Poor CN exposure due to body position. At present, there are two main methods for locating CN during surgery:
(1)电刺激可疑神经，通过监测阴茎根部周长的变化来定位CN。(1) Electrically stimulate the suspected nerve to locate the CN by monitoring changes in the circumference of the root of the penis.
CaverMap是目前唯一一个被FDA认可的用于术中CN监测的仪器。盆腔手术中，通过电刺激可疑神经，测量阴茎根部周长的变化，来定位CN。早期研究证实CaverMap可有效的帮助识别CN及术后辨别CN通路的完整性。Klotz等采用对比研究发现保留CN的前列腺癌根治术中未使用CaverMap仪器监测的患者，其术后仅有30%恢复勃起功能（部分及完全勃起），而使用CaverMap仪器监测的患者术后大约有94%恢复勃起功能。The CaverMap is currently the only FDA-approved instrument for intraoperative CN monitoring. During pelvic surgery, the CN is localized by electrical stimulation of the suspected nerve and measurement of changes in the circumference of the penis root. Early studies confirmed that CaverMap can effectively help identify CN and identify the integrity of the CN pathway after surgery. In a comparative study, Klotz et al found that only 30% of patients with CN-preserving radical prostatectomy who were not monitored by the CaverMap device regained erectile function (partial and complete erection) after surgery, while about 30% of the patients who were monitored by the CaverMap device after surgery 94% restore erectile function.
但是随着研究的深入，越来越多的结果显示CaverMap可重复性差，敏感性及特异性低，其术中的反应并不能反映患者术后的勃起功能，原因可能与以下有关：①术中可能会引起延迟的反应，比如当前的反应状态是前一个刺激的反应；②术中在CN走行区域的细小操作会引起阴茎周长的变化，对刺激产生的反应产生错误的判断；③术中阴茎周长自发性的变化，会误导术者；④术中麻醉方式及麻醉深度对阴茎周长的影响。However, with the deepening of research, more and more results show that CaverMap has poor repeatability, low sensitivity and specificity, and its intraoperative response does not reflect the postoperative erectile function of patients. The reasons may be related to the following: ① Intraoperative It may cause a delayed response, such as the current response state is the response to the previous stimulus; (2) During the operation, small operations in the CN running area will cause changes in the circumference of the penis, resulting in a wrong judgment on the response to the stimulus; (3) During the operation The spontaneous change of penis circumference will mislead the surgeon; ④ Influence of intraoperative anesthesia method and depth of anesthesia on penis circumference.
(2)电刺激可疑神经，通过监测阴茎海绵体内压（intracavernous pressure,ICP）的变化来定位CN。(2) Electrically stimulate the suspected nerve, and locate the CN by monitoring the changes of intracavernous pressure (ICP).
鉴于CaverMap仪器的缺陷，Kurokawa团队通过双极电极刺激可疑神经，监测ICP的变化在术中定位CN。研究显示ICP技术比CaverMap反应快、结果稳定，有更高的特异性与敏感性，但是测定一次ICP需要约10-60s，且在每次刺激之间需要1-2 min等待ICP稳定，会导致手术时间延长。并且同CaverMap一样无法实现持续的术中监测，而间断的神经监测仍有可能导致神经损伤。Given the shortcomings of the CaverMap instrument, Kurokawa's team stimulated suspicious nerves with bipolar electrodes to monitor changes in ICP and locate the CN intraoperatively. Studies have shown that ICP technology has a faster response, more stable results, and higher specificity and sensitivity than CaverMap. However, it takes about 10-60s to measure an ICP, and it takes 1-2 minutes to wait for the ICP to stabilize between each stimulation, which will lead to Operation time is prolonged. And like CaverMap, continuous intraoperative monitoring cannot be achieved, and intermittent neurological monitoring may still lead to neurological damage.
据此，在精准医疗战略的指引下，国内外学者进行了广泛的尝试及大量的研究，如术中采用激光神经刺激，染料荧光成像，光声成像及术中核磁共振等技术来定位及监测CN，但效果欠佳。Accordingly, under the guidance of the precision medicine strategy, scholars at home and abroad have carried out extensive attempts and a large number of studies, such as intraoperative use of laser nerve stimulation, dye fluorescence imaging, photoacoustic imaging and intraoperative nuclear magnetic resonance technology to locate and monitor CN, but the effect is not good.
诱发电位（evoked potentials, EPs）是指对神经系统某一特定部位（包括从感受器到大脑皮层）给予相宜的刺激，或使大脑对刺激信息进行加工，在神经系统相应部位检测出与刺激有固定时间间隔和特定位相的生物电反应，其有严格的锁时效应，是继心电、脑电和肌电后神经电生理的又一次发展。当前EPs已应用于脊柱外科术中对脊髓损伤的监测。临床研究显示，体感诱发电位联合运动诱发电位（motor evoked potentials, MEPs）可实现脊柱外科术中实时监测脊髓损伤，其敏感性高达94.4%，特异性高达100%。Evoked potentials (EPs) refer to giving appropriate stimulation to a specific part of the nervous system (including from the receptors to the cerebral cortex), or to make the brain process the stimulation information, and the corresponding parts of the nervous system are detected and stimulated. The bioelectrical response of time interval and specific phase, which has strict time-locking effect, is another development of neural electrophysiology after ECG, EEG and EMG. Currently EPs have been applied to the monitoring of spinal cord injury during spinal surgery. Clinical studies have shown that somatosensory evoked potentials combined with motor evoked potentials (MEPs) can realize real-time monitoring of spinal cord injury during spinal surgery, with a sensitivity of 94.4% and a specificity of 100%.
公开于该背景技术部分的信息仅仅旨在增加对本发明的总体背景的理解，而不应当被视为承认或以任何形式暗示该信息构成已为本领域一般技术人员所公知的现有技术。The information disclosed in this Background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person of ordinary skill in the art.
发明内容SUMMARY OF THE INVENTION
本发明的目的在于提供一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位监测仪。The purpose of the present invention is to provide an evoked potential monitor for real-time monitoring of penile cavernous nerve damage during laparoscopic surgery.
为解决上述问题，本专利提出以下技术方案：一种腹腔镜术中阴茎海绵体神经实时监测诱发电位仪，包括刺激信号输出线，所述刺激信号输出线包括依次连接的神经刺激探杆及输出线本体；所述输出线本体通过连接插头连接神经刺激探杆及诱发电位监测仪的电流刺激输出插座；诱发电位记录线，所述诱发电位记录线包括分别连接的正、负针记录电极及其相应诱发电位记录线本体；所述诱发电位记录线本体分别连接到诱发电位监测仪的诱发电位信号采集输入插座；参考电极线，所述参考电极线包括针形参考电极及参考电极线本体，参考电极线本体连接到诱发电位监测仪的参考信号采集插座。In order to solve the above-mentioned problems, this patent proposes the following technical solutions: a real-time monitoring evoked potential instrument of the cavernous nerve of the penis during laparoscopic surgery, including a stimulation signal output line, and the stimulation signal output line includes a nerve stimulation probe connected in turn and an output line. Line body; the output line body is connected to the nerve stimulation probe rod and the current stimulation output socket of the evoked potential monitor through the connecting plug; the evoked potential recording line, the evoked potential recording line includes respectively connected positive and negative needle recording electrodes and its The corresponding evoked potential recording line body; the evoked potential recording line body is respectively connected to the evoked potential signal acquisition input socket of the evoked potential monitor; the reference electrode line, the reference electrode line includes a needle-shaped reference electrode and a reference electrode line body, refer to The electrode wire body is connected to the reference signal acquisition socket of the evoked potential monitor.
优选地，所述神经刺激探杆直径5mm，长度340mm，前端为勾形电极，长约2cm，其他部分外层为绝缘体，尾端连接输出线本体。Preferably, the nerve stimulation probe has a diameter of 5 mm and a length of 340 mm, the front end is a hook electrode with a length of about 2 cm, the outer layer of other parts is an insulator, and the tail end is connected to the output wire body.
优选地，所述神经刺激探杆可通过腹腔镜术中穿刺曲卡，通过其前端刺激电极对术中可疑阴茎海绵体神经位置进行刺激，适用于腹腔镜微创手术，并且其外周的绝缘层可避免对其他组织的损伤。Preferably, the nerve stimulation probe can be used to puncture the trachea during laparoscopic surgery, and stimulate the suspicious position of the cavernosal nerve in the penis through its front-end stimulation electrode, which is suitable for laparoscopic minimally invasive surgery, and its peripheral insulating layer Damage to other tissues can be avoided.
优选地，所述正、负电极及参考电极针均为针形电极，呈圆柱形。Preferably, the positive electrode, the negative electrode and the reference electrode needle are all needle-shaped electrodes, which are cylindrical.
优选地，电位监测仪包括：刺激信号输出线，刺激信号输出线包括依次连接的神经刺激探杆及输出线本体；输出线插头连接到诱发电位监测仪器的电流刺激输出插座；诱发电位正极记录线包括依次连接的正极针形记录、诱发电位正极记录线本体，其通过输入线插头连接到诱发电位监测仪的信号采集输入插座；诱发电位负极记录线包括依次连接的负极针形记录、诱发电位负极记录线本体，其通过输入线插头连接到诱发电位监测仪的信号采集输入插座；参考电极线包括依次连接的参考电极线参考电极及参考电极线本体，其通过参考电极线连接插头连接到诱发电位监测仪的参考信号输入插座。Preferably, the potential monitor includes: a stimulation signal output line, the stimulation signal output line includes a nerve stimulation probe and an output line body connected in sequence; the output line plug is connected to the current stimulation output socket of the evoked potential monitoring instrument; the evoked potential positive recording line It includes the positive needle-shaped recording and the evoked potential positive recording line body connected in sequence, which are connected to the signal acquisition input socket of the evoked potential monitor through the input line plug; The recording line body is connected to the signal acquisition input socket of the evoked potential monitor through the input line plug; the reference electrode line includes the reference electrode line reference electrode and the reference electrode line body connected in sequence, which are connected to the evoked potential through the reference electrode line connection plug Monitor's reference signal input socket.
本发明对比现有技术可实现以下有益效果：相比现有技术中采用监测阴茎根部周长或者阴茎海绵体压力的变化，采用诱发电位的变化来监测阴茎海绵体神经的损伤，可实现监测的即时性及有效性，本专利对操作者的要求不高，可对术中可疑神经部位进行实时监测；Compared with the prior art, the present invention can realize the following beneficial effects: compared with the prior art, the change of the circumference of the root of the penis or the pressure of the corpus cavernosum is monitored, and the change of the evoked potential is used to monitor the damage of the corpus cavernosum, which can realize monitoring Immediacy and effectiveness, this patent does not have high requirements on the operator, and can conduct real-time monitoring of suspicious nerve parts during surgery;
本发明通过将正、负电极插入阴茎海绵体根部及冠状沟，利用阴茎海绵体神经与阴茎海绵体之间的支配关系来实现阴茎海绵体神经的实时监测，从而避免术中分离解剖前列腺时损伤阴茎海绵体神经，可最大限度的保留患者术后勃起功能。In the present invention, the positive and negative electrodes are inserted into the root of the corpus cavernosum and the coronal sulcus, and the innervation relationship between the corpus cavernosum and the corpus cavernosum is utilized to realize the real-time monitoring of the corpus cavernosum, thereby avoiding the damage when the prostate is separated and dissected during the operation. The cavernous nerve of the penis can preserve the erectile function of the patient to the greatest extent.
附图说明Description of drawings
图1为本发明一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪的刺激探杆结构示意图；Fig. 1 is the stimulation probe rod structure schematic diagram of the evoked potential instrument of real-time monitoring penis cavernous nerve injury in a kind of laparoscopy of the present invention;
图2为为本专利一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪的刺激输出信号结构示意图；Fig. 2 is the stimulation output signal structure schematic diagram of the evoked potential instrument of real-time monitoring penis cavernous nerve injury in a kind of laparoscopy of this patent;
图3为本专利一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪的诱发电位记录线及参考电极线结构示意图；3 is a schematic structural diagram of the evoked potential recording line and the reference electrode line of the evoked potential instrument for real-time monitoring of the evoked potential damage of the cavernous nerve of the penis in a laparoscopic operation of the patent;
图4为本诱发电位监测仪腹腔镜术中实际使用示意图；Figure 4 is a schematic diagram of the actual use of the evoked potential monitor in laparoscopic surgery;
其中，1、神经刺激探杆；2、刺激信号输出线；3、诱发电位记录线及参考电极线；4、诱发电位监测仪实际使用示意图；101、神经刺激探杆勾形电极；102、神经刺激探杆主体；103、神经刺激探杆外围绝缘层；104、刺激探杆与输出线本体连接插口；205、输出线本体；206、输出线本体与刺激探杆连接插头；207、输出线本体与诱发电位监测仪连接插头；3A08、诱发电位正极记录线针形电极；3A09、诱发电位正极记录线本体；3A10、诱发电位正极记录线与诱发电位监测仪连接插头；3B11、诱发电位负极记录线针形电极；3B12、诱发电位负极记录线本体；3B13、诱发电位负极记录线与诱发电位监测仪连接插头；3C14、参考电极线参考电极；3C15、参考电极线本体；3C16、参考电极线与诱发电位监测仪连接插头；417、诱发电位监测仪与刺激信号输出线连接插座；418、诱发电位监测仪与诱发电位正极记录线连接插座；419、诱发电位监测仪与诱发电位负极记录线连接插座；420、诱发电位监测仪与参考电极线连接插座；421、腹腔镜术中穿刺曲卡。Among them, 1. nerve stimulation probe; 2. stimulation signal output line; 3. evoked potential recording line and reference electrode line; 4. schematic diagram of the actual use of evoked potential monitor; 101, nerve stimulation probe hook electrode; 102, nerve main body of stimulation probe; 103, peripheral insulating layer of nerve stimulation probe; 104, connection socket between stimulation probe and output wire body; 205, output wire body; 206, connection plug between output wire body and stimulation probe rod; 207, output wire body Plug connected to evoked potential monitor; 3A08, evoked potential positive recording wire needle electrode; 3A09, evoked potential positive recording wire body; 3A10, evoked potential positive recording wire and evoked potential monitor connection plug; 3B11, evoked potential negative recording wire Needle electrode; 3B12, negative electrode recording wire body of evoked potential; 3B13, connecting plug of evoked potential negative recording wire and evoked potential monitor; 3C14, reference electrode wire reference electrode; 3C15, reference electrode wire body; 3C16, reference electrode wire and evoked potential monitor Potential monitor connection plug; 417, evoked potential monitor and stimulation signal output line connection socket; 418, evoked potential monitor and evoked potential positive recording line connection socket; 419, evoked potential monitor and evoked potential negative recording line connection socket; 420. Connect socket between evoked potential monitor and reference electrode line; 421. Puncture Quka during laparoscopy.
具体实施方式Detailed ways
下面结合附图对本发明一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪作进一步详细说明。The evoked potential instrument for real-time monitoring of penile cavernous nerve damage during laparoscopic surgery of the present invention will be described in further detail below with reference to the accompanying drawings.
如图1～图4所示，本发明一种腹腔镜术中实时监测阴茎海绵体神经损伤的诱发电位仪，包括：刺激信号输出线2，刺激信号输出线2包括依次连接的神经刺激探杆1及输出线本体205；输出线本体与诱发电位监测仪连接插头207连接到诱发电位监测仪与刺激信号输出线连接插座417；诱发电位正极记录线3A包括依次连接的诱发电位正极记录线针形电极3A08、诱发电位正极记录线本体3A09，其通过诱发电位正极记录线与诱发电位监测仪连接插头3A10连接到诱发电位监测仪与刺激信号输出线连接插座418；诱发电位负极记录线3B包括依次连接的诱发电位负极记录线针形电极3B11、诱发电位负极记录线本体3B12，其通过诱发电位负极记录线与诱发电位监测仪连接插头3B13连接到诱发电位监测仪与诱发电位负极记录线连接插座419；参考电极线3C包括依次连接的参考电极线参考电极3C14及参考电极线本体3C15，其通过参考电极线与诱发电位监测仪连接插头3C16连接到诱发电位监测仪与参考电极线连接插座420。As shown in FIGS. 1 to 4 , an evoked potential instrument for real-time monitoring of penile cavernous nerve damage during laparoscopic surgery of the present invention includes: a stimulation
使用时，刺激信号输出线2通过输出线本体与刺激探杆连接插头207连接到诱发电位监测仪器，通过神经刺激探杆勾形电极101，对腹腔镜术中可疑的神经部位进行电刺激； When in use, the stimulation
诱发电位正极记录线3A与诱发电位监测仪连接插头3A10连接到诱发电位监测仪与诱发电位正极记录线连接插座418，诱发电位负极记录线3B与诱发电位监测仪连接插头3B13连接到诱发电位监测仪与诱发电位负极记录线连接插座419，把诱发电位正极记录线针形电极3A08扎入阴茎根部，把诱发电位负极记录线针形电极3B11扎入阴茎冠状沟部，同时把参考电极线参考电极3C14插入患者大腿根部，将参考电极线与诱发电位监测仪连接插头3C16插入诱发电位监测仪与参考电极线连接插座420，用来记录患者的诱发电位。The evoked potential positive recording line 3A is connected to the evoked potential monitor. The plug 3A10 is connected to the evoked potential monitor and the evoked potential positive recording line is connected to the
同时，将诱发电位正极记录线本体3A09做成红色、诱发电位负极记录线本体3B12做成黄色、参考电极线本体3C15做成黑色，形成鲜明的区别，比较显眼，容易分清。At the same time, the evoked potential positive recording wire body 3A09 is made of red, the evoked potential negative electrode recording wire body 3B12 is made of yellow, and the reference electrode wire body 3C15 is made of black, forming a clear difference, which is more conspicuous and easy to distinguish.
另外，将神经刺激探杆1设为直径5mm，长度340mm，前端为勾形电极，其余部分外周有绝缘材料包裹，可通过腹腔镜术中穿刺曲卡418进行术中操作，有效避免术中损伤其他组织，诱发电位记录线及参考电极线3长度为1.5米，适合手术中使用。In addition, the nerve stimulation probe 1 is set to a diameter of 5mm and a length of 340mm. The front end is a hook electrode, and the rest of the periphery is wrapped with insulating material. The intraoperative operation can be performed by puncturing the Quka 418 during laparoscopic surgery, which can effectively avoid intraoperative damage. For other tissues, the length of the evoked potential recording line and the
以上已对本发明专利创造的较佳实施例进行了具体说明，但本发明专利并不限于实施例，熟悉本领域的技术人员在不违背本发明专利创造精神的前提下还可作出种种的等同的变型或替换，这些等同的变型或替换均包含在本申请的范围内。The preferred embodiments created by the patent of the present invention have been specifically described above, but the patent of the present invention is not limited to the embodiments, and those skilled in the art can make various equivalents without violating the spirit of the invention of the patent of the present invention. Modifications or substitutions, and equivalent modifications or substitutions, are included within the scope of this application.
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