技术领域Technical Field
本发明属于听觉测试技术领域，主要涉及一种用于大动物耳蜗电图长期监测的装置。The invention belongs to the technical field of hearing test, and mainly relates to a device for long-term monitoring of electrocochlear electrogram of large animals.
背景技术Background technique
耳蜗电图是一种记录声音刺激所诱发的耳蜗电反应的技术，其包括听神经复合动作电位(compound action potential,CAP)、耳蜗微音电位(cochlear microphonics,CM)以及总和电位(summating potential,SP)。有别于听性脑干反应等听觉诱发电位来源于中枢听觉通路上不同的核团，在观察耳蜗功能状态的实验研究中，只有耳蜗电图才能提供有关耳蜗生物电改变的直接证据。动物实验中，开展耳蜗电图长期监测对研究耳蜗功能变化具有重要意义。Electrocochlear electrogram (ECG) is a technique for recording the electrical responses of the cochlea induced by sound stimulation, including the compound action potential (CAP), cochlear microphonics (CM), and summing potential (SP). Unlike auditory evoked potentials such as auditory brainstem response (ABSR), which originate from different nuclei in the central auditory pathway, only ECG can provide direct evidence of changes in cochlear bioelectricity in experimental studies of cochlear functional status. In animal experiments, long-term monitoring of ECG is of great significance for studying changes in cochlear function.
耳蜗电图检查方法多为在测试耳给声的同时，通过放置于鼓膜表面、圆窗或圆窗龛的记录电极记录耳蜗生物电反应。如小型猪、羊等大动物进行耳蜗电图检查时，因其外耳道狭长深在，无创下将记录电极通过外耳道放置于鼓膜表面难以实现。大动物的耳蜗电图检查，现需要经手术放置记录电极后实施，但因记录电极在体内无法长期稳妥放置，检查结束后需将其取出，无法实现长期、稳定、连续的耳蜗电图监测。The electrocochlear examination method is to record the bioelectric response of the cochlea through recording electrodes placed on the surface of the tympanic membrane, the round window or the round window niche while testing the ear sound. When performing electrocochlear examination on large animals such as small pigs and sheep, it is difficult to place the recording electrode on the surface of the tympanic membrane through the external auditory canal without invasive means because their external auditory canals are narrow, long and deep. Electrocochlear examination of large animals currently requires surgical placement of recording electrodes, but because the recording electrodes cannot be placed safely in the body for a long time, they need to be removed after the examination, making it impossible to achieve long-term, stable and continuous electrocochlear monitoring.
现阶段，动物实验中尚无可用于耳蜗电图长期监测的装置。针对小鼠、大鼠、豚鼠等小动物，其实验观察期内体形变化较小，多通过手术放置记录电极，电极经牙科水泥固定后将记录电极引出并固定于颅顶，可实现耳蜗电图长期监测。但不同于前述小动物，小型猪、羊等用于耳科研究的大动物在实验期内颅围仍有较大变化，且动物活动时动作剧烈，对体内记录电极延展性、采集端及输入端固定强度提出了更高的要求。将小动物的技术路线用于大动物耳蜗电图长期监测，会出现记录电极电极移位、记录电极中部拉扯断裂、颅顶信号输入端受外力撞击脱位等情况。现有技术尚无法解决大动物耳蜗电图长期监测的难题。At present, there is no device that can be used for long-term monitoring of cochlear electrograms in animal experiments. For small animals such as mice, rats, and guinea pigs, their body shape changes little during the experimental observation period, and recording electrodes are usually placed surgically. After the electrodes are fixed with dental cement, the recording electrodes are led out and fixed to the top of the skull, which can achieve long-term monitoring of cochlear electrograms. However, unlike the aforementioned small animals, large animals used for otolaryngology research, such as miniature pigs and sheep, still have large changes in cranial circumference during the experimental period, and the animals move violently during activities, which puts higher requirements on the ductility of the recording electrodes in the body and the fixing strength of the acquisition and input ends. If the technical route of small animals is used for long-term monitoring of cochlear electrograms in large animals, there will be situations such as displacement of the recording electrode, pulling and breaking of the middle part of the recording electrode, and dislocation of the signal input end of the skull due to external force impact. Existing technologies are still unable to solve the problem of long-term monitoring of cochlear electrograms in large animals.
发明内容Summary of the invention
本发明的目的在于，克服现有技术的上述缺陷，从而提供一种用于大动物耳蜗电图长期监测的装置，可解决大动物听觉实验中无法长期、稳定监测耳蜗电图的难题。The purpose of the present invention is to overcome the above-mentioned defects of the prior art, thereby providing a device for long-term monitoring of the cochlear electrogram of large animals, which can solve the problem that the cochlear electrogram cannot be monitored long-term and stably in large animal auditory experiments.
为解决上述技术问题，本发明的技术方案所提供的用于大动物耳蜗电图长期监测的装置，包括：电极1、传输线卡扣2、信号传输线、至少一个信号传输线盒、颅顶固定基座8、信号输入端23和外部连接组件；In order to solve the above technical problems, the technical solution of the present invention provides a device for long-term monitoring of cochlear electrogram of large animals, comprising: an electrode 1, a transmission line buckle 2, a signal transmission line, at least one signal transmission line box, a skull top fixing base 8, a signal input terminal 23 and an external connection component;
所述颅顶固定基座8固定于颅骨；The skull top fixing base 8 is fixed to the skull;
所述信号传输线的一端与所述电极1连接，另一端穿过所述信号传输线盒并在颅顶固定基座8内与外部连接组件连接；所述信号传输线与外部连接组件的连接处，通过信号输入端23固定；One end of the signal transmission line is connected to the electrode 1, and the other end passes through the signal transmission line box and is connected to the external connection component in the skull fixation base 8; the connection between the signal transmission line and the external connection component is fixed by the signal input terminal 23;
所述外部连接组件还可分离地连接信号采集处理器18；The external connection component can also be detachably connected to the signal acquisition processor 18;
所述信号传输线具有盈余量，其在所述电极1与颅顶固定基座8之间的长度大于所述电极1与颅顶固定基座8之间的颅骨表面连接线的长度；The signal transmission line has a surplus, and its length between the electrode 1 and the skull top fixing base 8 is greater than the length of the skull surface connection line between the electrode 1 and the skull top fixing base 8;
所述信号传输线盒与电极1之间，至少通过一个传输线卡扣2将所述信号传输线固定于颅骨。The signal transmission line is fixed to the skull via at least one transmission line buckle 2 between the signal transmission line box and the electrode 1 .
作为上述装置的一种改进，所述电极1固定于信号采集点，用于采集诱发的耳蜗电信号；所述电极1的材质为高导材料；基于信号采集点的具体结构，所述电极1的外形选用直角勾状、倒勾状、针状、箭头状、盘状或凹面盘状，其直径或厚度为0.010-0.020英寸。As an improvement of the above device, the electrode 1 is fixed at the signal collection point to collect the induced cochlear electrical signal; the material of the electrode 1 is a high-conductivity material; based on the specific structure of the signal collection point, the shape of the electrode 1 is selected to be a right-angle hook, an inverted hook, a needle, an arrow, a disk or a concave disk, and its diameter or thickness is 0.010-0.020 inches.
作为上述装置的一种改进，所述电极1与所述传输线卡扣2之间的信号传输线呈至少一个S形延伸；两个所述传输线卡扣2之间至少设置一个信号传输线盒；从而使信号传输线具有盈余量，防止电极1受信号传输线拉力而脱出并防止信号传输线断裂。As an improvement of the above device, the signal transmission line between the electrode 1 and the transmission line buckle 2 extends in at least one S shape; at least one signal transmission line box is arranged between the two transmission line buckles 2; so that the signal transmission line has a surplus amount, preventing the electrode 1 from falling out due to the pulling force of the signal transmission line and preventing the signal transmission line from breaking.
作为上述装置的一种改进，所述信号传输线的材质为高导材料，以提高信号传输效率并减少信号损耗，信号传输线外部由绝缘层包裹，避免传输路径上的干扰。As an improvement of the above device, the signal transmission line is made of a high-conductivity material to improve signal transmission efficiency and reduce signal loss. The outside of the signal transmission line is wrapped by an insulating layer to avoid interference on the transmission path.
作为上述装置的一种改进，所述传输线卡扣2在面向颅顶的面设置有用于卡住信号传输线的S形线槽2-1；所述传输线卡扣2通过螺钉固定于电极放置处附近的颅骨，确保电极放置稳妥不移位。As an improvement of the above device, the transmission line buckle 2 is provided with an S-shaped wire groove 2-1 for clamping the signal transmission line on the surface facing the top of the skull; the transmission line buckle 2 is fixed to the skull near the electrode placement by screws to ensure that the electrode is placed securely and does not shift.
作为上述装置的一种改进，所述信号传输线盒包括信号传输盒上盖4和信号传输盒下盖5；As an improvement of the above device, the signal transmission box comprises a signal transmission box upper cover 4 and a signal transmission box lower cover 5;
所述信号传输盒上盖4和信号传输盒下盖5分别通过液态硅胶注塑成型，所述信号传输盒上盖4和信号传输盒下盖5通过硅胶粘合剂粘合后，经烘烤粘合密封；The upper cover 4 of the signal transmission box and the lower cover 5 of the signal transmission box are respectively formed by liquid silicone injection molding, and the upper cover 4 of the signal transmission box and the lower cover 5 of the signal transmission box are bonded by silicone adhesive and then baked and bonded to seal;
所述信号传输线盒内部中空，两端分别设置出线孔4-2；所述出线孔4-2处设置防水机构；所述信号传输线在信号传输线盒内呈至少一个S形、至少一个Z形或螺旋形延伸，使所述信号传输线具有盈余量。The signal transmission box is hollow inside, and has outlet holes 4-2 at both ends; a waterproof mechanism is provided at the outlet holes 4-2; the signal transmission line extends in at least one S shape, at least one Z shape or spiral shape in the signal transmission box, so that the signal transmission line has a surplus.
作为上述装置的一种改进，所述颅顶固定基座8，包括基座底部、基座颈部8-2和基座顶部；其中，As an improvement of the above device, the skull top fixing base 8 includes a base bottom, a base neck 8-2 and a base top; wherein,
所述基座底部具有贴合颅骨形状的弧度，通过螺钉与颅骨固定连接；The bottom of the base has a curvature that fits the shape of the skull and is fixedly connected to the skull via screws;
所述基座颈部8-2设置至基座底部与基座顶部之间；The base neck 8-2 is arranged between the base bottom and the base top;
所述基座底部和基座颈部8-2中心处沿所述基座颈部8-2轴线设置供信号传输线穿入的过孔8-4；A through hole 8-4 for the signal transmission line to pass through is provided at the bottom of the base and the center of the base neck 8-2 along the axis of the base neck 8-2;
所述基座顶部，内部设置绝缘子8-1，外部为信号输入端23；其中，The top of the base has an insulator 8-1 inside and a signal input terminal 23 outside;
所述绝缘子8-1内部设置有与信号传输线匹配连接的信号传输线母头1-3；The insulator 8-1 is provided with a signal transmission line female connector 1-3 matched with the signal transmission line;
所述基座底部、基座颈部8-2和基座顶部的材质包括：钛合金；所述绝缘子8-1的材质包括：陶瓷和红宝石。The materials of the base bottom, base neck 8 - 2 and base top include: titanium alloy; the materials of the insulator 8 - 1 include: ceramic and ruby.
作为上述装置的一种改进，所述装置还包括：保护帽6，所述保护帽6设置有密封圈，并可分离地与所述信号输入端23外侧的螺纹连接。As an improvement of the above device, the device further comprises: a protective cap 6 , wherein the protective cap 6 is provided with a sealing ring and is detachably connected to the thread on the outer side of the signal input end 23 .
作为上述装置的一种改进，所述装置还包括：套在所述基座颈部8-2的环状的创口贴片7；所述创口贴片7的材质包括：硅胶；所述创口贴片7在朝向颅骨的面上设置有生物粘胶7-1。As an improvement of the above device, the device further comprises: an annular wound patch 7 sleeved on the base neck 8-2; the material of the wound patch 7 comprises: silicone; the wound patch 7 is provided with biological adhesive 7-1 on the surface facing the skull.
作为上述装置的一种改进，所述外部连接组件包括：第二连接线14以及分别与第二连接线14端部连接的传输线公头21和插头22；As an improvement of the above device, the external connection assembly includes: a second connection line 14 and a transmission line male connector 21 and a plug 22 respectively connected to the ends of the second connection line 14;
所述传输线公头21具有螺纹连接部和插针部，所述螺纹连接部可分离地与所述信号输入端23外侧的螺纹连接，所述插针部与所述信号传输线母头1-3匹配；The transmission line male connector 21 has a threaded connection portion and a pin portion, the threaded connection portion is detachably connected to the thread on the outside of the signal input end 23, and the pin portion matches the signal transmission line female connector 1-3;
所述插头22可分离地与外部信号采集处理器18连接。The plug 22 is detachably connected to the external signal acquisition processor 18 .
相较于现有技术，本发明的优点在于，本发明的用于大动物耳蜗电图长期监测的装置在应用时，可根据信号采集点结构选用适宜的电极形状，便于将记录电极稳妥固定于耳蜗附近的信号采集点，信号输入端口可通过颅顶固定基座稳妥固定于颅顶，电极与信号输入端之间利用螺钉与传输线卡扣固定，信号传输线盒中信号传输线的可伸展设计能够避免因动物颅骨发育所导致的记录电极采集端移位或信号传输线拉伸断裂。Compared with the prior art, the advantage of the present invention is that when the device for long-term monitoring of cochlear electrograms of large animals is used, a suitable electrode shape can be selected according to the structure of the signal collection point, so that the recording electrode can be securely fixed to the signal collection point near the cochlea. The signal input port can be securely fixed to the top of the skull through a skull fixation base, and the electrode and the signal input end are fixed with screws and transmission line clips. The stretchable design of the signal transmission line in the signal transmission box can avoid displacement of the recording electrode collection end or stretching and breakage of the signal transmission line due to the development of the animal's skull.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为本发明提供的用于大动物耳蜗电图长期监测的装置的立体图；FIG1 is a perspective view of a device for long-term monitoring of electrocochlear electrograms of large animals provided by the present invention;
图2为本发明提供的用于大动物耳蜗电图长期监测的装置的爆炸图；FIG2 is an exploded view of a device for long-term monitoring of electrocochlear electrograms of large animals provided by the present invention;
图3为电极1与信号传输线的结构示意图；FIG3 is a schematic diagram of the structure of the electrode 1 and the signal transmission line;
图4为电极1的形状示意图；FIG4 is a schematic diagram of the shape of the electrode 1;
图5(a)为传输线卡扣2的立体图；FIG5( a ) is a three-dimensional view of the transmission line buckle 2 ;
图5(b)为传输线卡扣2的结构示意图；FIG5( b ) is a schematic structural diagram of the transmission line buckle 2;
图6(a)颅顶固定基座8的立体图；FIG6 (a) is a stereoscopic view of the skull fixation base 8;
图6(b)为保护帽6、创口贴片7和颅顶固定基座8的连接示意图；FIG6( b ) is a schematic diagram of the connection between the protective cap 6 , the wound patch 7 and the skull top fixing base 8 ;
图7为外部连接组件的结构示意图；FIG7 is a schematic diagram of the structure of an external connection assembly;
图8为用于大动物耳蜗电图长期监测的装置的连接及操作示意图。FIG8 is a schematic diagram showing the connection and operation of a device for long-term electrocochlear monitoring of large animals.
附图标识Figure ID
1、电极 2、传输线卡扣 3、第一固定螺钉1. Electrode 2. Transmission line buckle 3. First fixing screw
4、信号传输盒上盖 5、信号传输盒下盖 6、保护帽4. Signal transmission box upper cover 5. Signal transmission box lower cover 6. Protective cap
7、创口贴片 8、颅顶固定基座 9、第二固定螺钉7. Band-aid 8. Skull top fixation base 9. Second fixation screw
10、第三固定螺钉 11、接地电极 12、参考电极10. Third fixing screw 11. Ground electrode 12. Reference electrode
13、第一连接线 14、第二连接线 15、第三连接线13. First connecting line 14. Second connecting line 15. Third connecting line
16、扬声器 17、第四连接线 18、信号采集处理器16. Speaker 17. Fourth connecting line 18. Signal acquisition processor
19、第五连接线 20、计算机 21、传输线公头19. Fifth connecting line 20. Computer 21. Transmission line male connector
22、插头 23、信号输入端 1-1、信号传输线第一拆弯部22. Plug 23. Signal input terminal 1-1. First bend of signal transmission line
1-2、信号传输线第二拆弯部 1-3、信号传输线母头 1-4、信号传输线第三弯折部1-2, the second bending part of the signal transmission line 1-3, the female connector of the signal transmission line 1-4, the third bending part of the signal transmission line
2-1、S形线槽 2-2、第一螺钉孔 2-3、第一R角2-1, S-shaped wire groove 2-2, first screw hole 2-3, first R angle
2-4、第一斜度 2-5、第二R角 2-6、第三R角2-4, first slope 2-5, second R angle 2-6, third R angle
2-7、第二斜度 4-1、缩紧环 4-2、出线孔2-7, second slope 4-1, tightening ring 4-2, wire outlet hole
6-1、密封圈 6-2、螺纹连接结构 7-1、生物粘胶6-1. Sealing ring 6-2. Threaded connection structure 7-1. Bioadhesive
8-1、绝缘子 8-2、基座颈部 8-3、第二螺钉孔8-1. Insulator 8-2. Base neck 8-3. Second screw hole
8-4、传输线过孔 8-5、第三螺钉孔8-4, Transmission line via hole 8-5, Third screw hole
具体实施方式Detailed ways
以下结合实施例进一步说明本发明所提供的技术方案。The technical solution provided by the present invention is further illustrated below in conjunction with embodiments.
本发明提出一种用于大动物耳蜗电图长期监测的装置，该装置为埋置式。利用此装置可将电极妥善固定于耳蜗电信号采集点，可利用传输线卡扣完成体内稳妥固定，通过信号传输线盒实现其内信号传输线的可延展设计，使信号传输线可随动物颅骨发育拉长，避免信号传输线断裂，通过颅顶固定基座将信号输入端妥善固定于颅骨，除固定基座上部裸露外，其余部分均在体内埋置。解决了大动物无法进行长期、稳定、可靠耳蜗电图监测的问题。The present invention proposes a device for long-term monitoring of cochlear electrograms of large animals, which is an embedded device. The device can be used to properly fix the electrodes at the cochlear electrical signal collection point, and the transmission line buckle can be used to complete the secure fixation in the body. The signal transmission line box realizes the extensible design of the signal transmission line inside, so that the signal transmission line can be elongated with the development of the animal's skull to avoid the signal transmission line from breaking. The signal input end is properly fixed to the skull through the skull top fixing base. Except for the exposed upper part of the fixing base, the rest of the parts are buried in the body. The problem that large animals cannot perform long-term, stable and reliable cochlear electrogram monitoring is solved.
本发明提出一种用于大动物耳蜗电图长期监测的装置，该装置包括：电极1、信号传输线、传输线卡扣2、信号传输盒上盖4和信号传输盒下盖5组成的信号传输线盒、颅顶固定基座8、固定螺钉(第一固定螺钉3和第二固定螺钉9、第三固定螺钉10)、信号输入端23、外部连接组件(由传输线公头21、第二连接线14和插头22构成)。The present invention provides a device for long-term monitoring of cochlear electrogram of large animals, which includes: an electrode 1, a signal transmission line, a transmission line buckle 2, a signal transmission box consisting of an upper cover 4 and a lower cover 5 of the signal transmission box, a skull fixation base 8, fixing screws (a first fixing screw 3, a second fixing screw 9, and a third fixing screw 10), a signal input terminal 23, and an external connection component (consisting of a transmission line male connector 21, a second connecting line 14, and a plug 22).
电极1，用于将装置妥善固定于信号采集点，采集诱发的耳蜗电信号。其材质为高导材料，如纯银、银铜合金、纯铜表面镀金、黄金、铂金、铂铱合金等，以保证微弱电信号采集效率；如图4所示，其外形可为直角勾状、倒勾状、针状、箭头状、盘状、凹面盘状等，可根据固定部位实际选用；其直径或厚度为0.010-0.020英寸，以保证固定牢固度与强度。Electrode 1 is used to properly fix the device at the signal collection point to collect the induced cochlear electrical signal. It is made of high-conductivity materials, such as pure silver, silver-copper alloy, pure copper surface plated with gold, gold, platinum, platinum-iridium alloy, etc., to ensure the efficiency of weak electrical signal collection; as shown in Figure 4, its shape can be right-angle hook, inverted hook, needle, arrowhead, disk, concave disk, etc., which can be selected according to the actual fixing position; its diameter or thickness is 0.010-0.020 inches to ensure the firmness and strength of the fixation.
信号传输线，用于传输采集到的耳蜗电信号。其材质为被覆绝缘层的高导材料，保证信号传输效率减少信号损耗，绝缘层可避免传输路径上其他电信号传入及干扰；其直径为0.010-0.020英寸，保证其同时具有强度和柔韧性。如图3所示，其接近电极1的起始段预制为“S”形的信号传输线第一拆弯部1-1，可保证电极1与传输线卡扣2之间的信号传输线有一定延展性，防止动物生长时致电极1脱出。本实施例中，为避免信号传输线变形或过度弯折而采用了“S”形的信号传输线第一拆弯部1-1，但在其他实施例中，也可以采用其他可以使信号传输线具有盈余量的形状，比如Z形。The signal transmission line is used to transmit the collected cochlear electrical signals. It is made of a high-conductivity material covered with an insulating layer to ensure signal transmission efficiency and reduce signal loss. The insulating layer can prevent other electrical signals from entering and interfering on the transmission path; its diameter is 0.010-0.020 inches, ensuring that it has both strength and flexibility. As shown in Figure 3, the starting section close to the electrode 1 is prefabricated as an "S"-shaped first bend 1-1 of the signal transmission line, which can ensure that the signal transmission line between the electrode 1 and the transmission line buckle 2 has a certain ductility to prevent the electrode 1 from falling out when the animal grows. In this embodiment, an "S"-shaped first bend 1-1 of the signal transmission line is used to avoid deformation or excessive bending of the signal transmission line, but in other embodiments, other shapes that can give the signal transmission line a surplus, such as a Z shape, can also be used.
传输线卡扣2，用于将信号传输线固定于骨面。如图5(a)和图6(b)所示，传输线卡扣2一面光滑，另一面有一S形线槽2-1，可将信号传输线第二弯折部1-2塑形为S形后纳于该S形线槽2-1，可靠的固定信号传输线的电极端；传输线卡扣2一侧设有第一螺钉孔2-2用于螺钉固定，传输线卡扣2经螺钉固定于骨面，保证电极1稳定性。电极1与信号输入端23之间可设置多个传输线卡扣2用于固定。该传输线卡扣2的材质为可植入金属，如钛合金、不锈钢等，或者为可植入高分子材料，如聚醚醚酮PEEK等。The transmission line buckle 2 is used to fix the signal transmission line to the bone surface. As shown in Figure 5(a) and Figure 6(b), the transmission line buckle 2 has a smooth surface on one side and an S-shaped wire groove 2-1 on the other side. The second bending portion 1-2 of the signal transmission line can be shaped into an S shape and then inserted into the S-shaped wire groove 2-1 to reliably fix the electrode end of the signal transmission line; a first screw hole 2-2 is provided on one side of the transmission line buckle 2 for screw fixation. The transmission line buckle 2 is fixed to the bone surface by screws to ensure the stability of the electrode 1. Multiple transmission line buckles 2 can be set between the electrode 1 and the signal input end 23 for fixation. The material of the transmission line buckle 2 is an implantable metal, such as titanium alloy, stainless steel, etc., or an implantable polymer material, such as polyetheretherketone PEEK, etc.
信号传输盒上盖4和信号传输盒下盖5组成的信号传输线盒，用于收纳盈余的信号传输线，作为信号传输线的延续，使信号传输线随动物颅骨发育或活动可自信号传输线盒中抽出，以增加长度，从而保证信号传输线延展性，确保不因张力过大致信号传输线断裂。The signal transmission box consisting of the signal transmission box upper cover 4 and the signal transmission box lower cover 5 is used to store surplus signal transmission lines as a continuation of the signal transmission lines, so that the signal transmission lines can be drawn out of the signal transmission box as the animal's skull develops or moves to increase the length, thereby ensuring the ductility of the signal transmission lines and ensuring that the signal transmission lines are not broken due to excessive tension.
信号传输盒为医用级硅胶材质，信号传输盒上盖4和信号传输盒下盖5通过液态硅胶注塑成形，具有良好生物相容性。信号传输线盒中空，两端设有防水机构，防止体液进入传输线盒内；传输线盒可为扁条形、椭圆柱形或圆柱形，信号传输线的信号传输线第三弯折部1-4绕制成至少一个S形、至少一个Z形或螺旋形收纳于传输线盒内，盒内信号传输线可抽出。信号传输盒上盖4和信号传输盒下盖5通过硅胶粘合剂粘合后，150℃烘烤5分钟粘合密封，形成一个密封的信号传输线盒。信号传输线盒两端设有出线孔4-2，信号传输线可自此抽出。信号传输线盒两端设有缩紧环4-1，可防止组织和体液进入盒内。信号传输线盒两端可利用传输线卡扣2固定，传输线卡扣2间可有一个或多个长短不一的信号传输线盒。The signal transmission box is made of medical grade silicone material. The upper cover 4 and the lower cover 5 of the signal transmission box are formed by liquid silicone injection molding and have good biocompatibility. The signal transmission box is hollow, and waterproof mechanisms are provided at both ends to prevent body fluids from entering the transmission box; the transmission box can be flat, elliptical or cylindrical, and the third bending portion 1-4 of the signal transmission line is wound into at least one S shape, at least one Z shape or spiral shape and stored in the transmission box, and the signal transmission line in the box can be pulled out. After the upper cover 4 and the lower cover 5 of the signal transmission box are bonded by silicone adhesive, they are baked at 150°C for 5 minutes to bond and seal to form a sealed signal transmission box. There are outlet holes 4-2 at both ends of the signal transmission box, and the signal transmission line can be pulled out from there. There are tightening rings 4-1 at both ends of the signal transmission box to prevent tissue and body fluids from entering the box. The two ends of the signal transmission box can be fixed by transmission line buckles 2, and there can be one or more signal transmission boxes of different lengths between the transmission line buckles 2.
保护帽6，材质可以是钛合金、不锈钢或塑料PP，带有内螺牙，内置密封圈6-1，作用：保护信号输入端23，为信号输入端23防尘、防水。The protective cap 6 can be made of titanium alloy, stainless steel or plastic PP, has internal threads and a built-in sealing ring 6-1, and its function is to protect the signal input terminal 23 and to prevent dust and water from entering the signal input terminal 23.
创口贴片7，材质可以是硅胶，形状为环状硅胶垫片，与创口接触的一面涂布一层生物粘胶7-1，用于防止创口感染。创口贴片7的中心孔与颅顶固定基座8的轴滑配，可根据颅骨面到皮肤的厚度D，进行调节创口贴位置，适配多种体形动物。The wound patch 7 can be made of silicone and is in the shape of a ring-shaped silicone gasket. The side in contact with the wound is coated with a layer of bioadhesive 7-1 to prevent wound infection. The central hole of the wound patch 7 is slidably matched with the axis of the skull top fixing base 8, and the position of the wound patch can be adjusted according to the thickness D from the skull surface to the skin, so as to adapt to animals of various body shapes.
颅顶固定基座8，用于将信号输入端固定于颅顶。其底部为圆角长方形，具有一定弧度以贴合颅骨形状；其两侧分别设置第二螺钉孔8-3和第三螺钉孔8-5，用于螺钉固定；底座中部留供传输线母头1-3穿入的传输线过孔8-4，传输线母头1-3穿入后固定于绝缘子8-1中，顶端镶嵌于螺栓状信号输入端23。颅顶固定基座8的材质可以是钛合金。绝缘子8-1可以起到绝缘作用，材质可以是陶瓷或红宝石。基座颈部8-2设计成圆柱形，直径可以是2-5mm,颈部长度可以是10-30mm；上面装有特制环状的创口贴片7，创口贴片7在圆柱上位置可调。The top of the skull fixing base 8 is used to fix the signal input terminal to the top of the skull. Its bottom is a rounded rectangle with a certain curvature to fit the shape of the skull; a second screw hole 8-3 and a third screw hole 8-5 are respectively arranged on both sides for screw fixing; a transmission line through hole 8-4 is reserved in the middle of the base for the transmission line female connector 1-3 to pass through, and the transmission line female connector 1-3 is fixed in the insulator 8-1 after passing through, and the top is embedded in the bolt-shaped signal input terminal 23. The material of the top of the skull fixing base 8 can be titanium alloy. The insulator 8-1 can play an insulating role, and the material can be ceramic or ruby. The base neck 8-2 is designed to be cylindrical, the diameter can be 2-5mm, and the neck length can be 10-30mm; a special ring-shaped band-aid 7 is installed on it, and the position of the band-aid 7 on the cylinder is adjustable.
第一固定螺钉3和第二固定螺钉9，用于将传输线卡扣2与颅顶固定基座8固定于乳突及颅顶骨质。螺钉均为自攻螺钉，固定螺钉形号可根据基座螺孔孔径选用(1.2mm/1.7mm)。固定螺钉的材质可以是钛合金或不锈钢。The first fixing screw 3 and the second fixing screw 9 are used to fix the transmission line buckle 2 and the skull fixing base 8 to the mastoid and skull bone. The screws are all self-tapping screws, and the shape of the fixing screws can be selected according to the hole diameter of the base screw hole (1.2mm/1.7mm). The material of the fixing screws can be titanium alloy or stainless steel.
信号输入端23，用于在信号传输线与外部连接组件(由传输线公头21、第二连接线14和插头22构成)间提供连接机构。其顶部为外螺内孔结构，内孔结构为信号传输线母头1-3，为高导材料，底部可与从信号传输盒引出的信号传输线连接，并固定于绝缘子8-1，固定方式可以为镶嵌；不测试时可用信号输入端保护帽6封闭保护。The signal input terminal 23 is used to provide a connection mechanism between the signal transmission line and the external connection component (composed of the transmission line male connector 21, the second connection line 14 and the plug 22). The top is an external screw inner hole structure, the inner hole structure is the signal transmission line female connector 1-3, which is made of high-conductivity material, and the bottom can be connected to the signal transmission line led out from the signal transmission box and fixed to the insulator 8-1, and the fixing method can be embedded; when not testing, the signal input terminal protection cap 6 can be used to close and protect it.
第二连接线14，用于连接信号输入端23与外部信号采集处理器18。其头端为传输线公头21，内螺内针结构，可与信号输入端23匹配连接，内针结构为高导材料；尾端为一内孔插头22可接外部信号采集处理器18。The second connecting line 14 is used to connect the signal input terminal 23 with the external signal acquisition processor 18. The head end is a transmission line male connector 21, with an inner screw and inner needle structure, which can match and connect with the signal input terminal 23, and the inner needle structure is a high-conductivity material; the tail end is an inner hole plug 22 that can be connected to the external signal acquisition processor 18.
设备连接及操作流程如图8所示：前述用于大动物耳蜗电图长期监测的装置经手术放置，电极1固定于耳蜗电信号采集点，信号输入端23固定于颅顶；参考电极12置于给声耳耳垂下，接地电极11置于对侧耳耳垂下，传输线公头21与信号传入端23连接后，尾端插头22接于外部信号采集处理器18；信号采集处理器18引出的扬声器16放置于动物测试耳旁；根据检查项目完成诱导声参数设置；根据检查项目完成信号分析参数设置；检查开始后扬声器16发声诱发受试耳产生信号，信号接入外部信号采集处理器18，连接计算机20显示波形，保存波形以进行定量分析。The equipment connection and operation process are shown in Figure 8: the aforementioned device for long-term monitoring of cochlear electrogram of large animals is placed surgically, the electrode 1 is fixed to the cochlear electrical signal collection point, and the signal input terminal 23 is fixed to the top of the skull; the reference electrode 12 is placed under the earlobe of the sound-giving ear, and the ground electrode 11 is placed under the earlobe of the contralateral ear. After the male connector 21 of the transmission line is connected to the signal input terminal 23, the tail plug 22 is connected to the external signal acquisition processor 18; the speaker 16 led out from the signal acquisition processor 18 is placed next to the test ear of the animal; the induced sound parameter setting is completed according to the inspection items; the signal analysis parameter setting is completed according to the inspection items; after the inspection starts, the speaker 16 sounds to induce the test ear to generate a signal, the signal is connected to the external signal acquisition processor 18, and the computer 20 is connected to display the waveform, and the waveform is saved for quantitative analysis.
CAP检查的参数设置及分析方法为：The parameter settings and analysis methods for CAP inspection are as follows:
分别使用Click及短纯音(1kHz、2kHz、4kHz、8kHz、16kHz、20kHz)诱发；刺激声强度自90dB SPL开始，观察并记录所引出波形的N1、N2波；确定阈值时，以10dB为阶梯逐次降低刺激声强度，直至N1波消失，然后再增加5dB声强，观察能否引出波形，可引出波形的最小声强为该刺激声的CAP阈值。诱导声参数设置：交替相位；短纯音上升下降时间为0.4ms，持续时间1ms,刺激频率21次/s。Click and short pure tone (1kHz, 2kHz, 4kHz, 8kHz, 16kHz, 20kHz) were used to induce respectively; the intensity of the stimulus sound started from 90dB SPL, and the N1 and N2 waves of the induced waveform were observed and recorded; when determining the threshold, the intensity of the stimulus sound was gradually reduced by 10dB until the N1 wave disappeared, and then the sound intensity was increased by 5dB to observe whether the waveform could be induced. The minimum sound intensity that could induce the waveform was the CAP threshold of the stimulus sound. Induced sound parameter settings: alternating phase; the rise and fall time of the short pure tone was 0.4ms, the duration was 1ms, and the stimulation frequency was 21 times/s.
波形采集设置：叠加次数200次；观察窗10ms；带通滤波：高通100Hz，低通3kHz。Waveform acquisition settings: stacking times 200 times; observation window 10ms; bandpass filtering: high pass 100Hz, low pass 3kHz.
波形分析方法：波形横轴为时间轴，纵轴为电压轴，N1波出现前的平台为基线，所采集N1波波顶的横轴数值为CAP潜伏期，N1波顶-峰值电压为CAP幅值。Waveform analysis method: The horizontal axis of the waveform is the time axis, the vertical axis is the voltage axis, the platform before the appearance of the N1 wave is the baseline, the horizontal axis value of the collected N1 wave top is the CAP latency, and the N1 wave top-peak voltage is the CAP amplitude.
CM检查的参数设置及分析方法为：The parameter settings and analysis methods for CM inspection are:
分别使用短纯音(1kHz、2kHz、4kHz、8kHz)诱发；刺激声强度自90dB SPL开始，观察并记录所引出的正弦样波形；确定反应阈时，以10dB为阶梯逐次降低刺激声强度，直至波形消失，然后再增加5dB声强，观察能否引出波形，可引出波形的最小声强为该刺激声的CM反应阈。Use short pure tones (1kHz, 2kHz, 4kHz, 8kHz) to induce respectively; the stimulus sound intensity starts from 90dB SPL, and observe and record the induced sinusoidal waveform; when determining the reaction threshold, reduce the stimulus sound intensity in steps of 10dB until the waveform disappears, and then increase the sound intensity by 5dB to observe whether the waveform can be induced. The minimum sound intensity that can induce the waveform is the CM reaction threshold of the stimulus sound.
诱导声参数设置：固定相位；短纯音上升下降时间为1ms，持续时间10ms,刺激频率21次/s。The induced sound parameter settings were as follows: fixed phase; the rise and fall time of short pure tone was 1ms, the duration was 10ms, and the stimulation frequency was 21 times/s.
波形采集设置：叠加次数20次；观察窗20ms；1kHz诱导时带通滤波高通500Hz低通1kHz，2kHz诱导时带通滤波高通500Hz低通3kHz，4kHz诱导时带通滤波高通3kHz低通5kHz，8kHz诱导时带通滤波高通7kHz低通10kHz。Waveform acquisition settings: 20 times of superposition; 20ms observation window; bandpass filter high pass 500Hz low pass 1kHz when inducing at 1kHz, bandpass filter high pass 500Hz low pass 3kHz when inducing at 2kHz, bandpass filter high pass 3kHz low pass 5kHz when inducing at 4kHz, bandpass filter high pass 7kHz low pass 10kHz when inducing at 8kHz.
波形分析方法：波形横轴为时间轴，纵轴为电压轴，波顶与波谷差值为CM幅值。Waveform analysis method: The horizontal axis of the waveform is the time axis, the vertical axis is the voltage axis, and the difference between the peak and the trough is the CM amplitude.
SP检查的参数设置及分析方法为：The parameter settings and analysis methods for SP inspection are as follows:
分别使用Click及短纯音(1kHz、2kHz、4kHz、8kHz、16kHz、20kHz)诱发；刺激声强度自90dB SPL开始，观察并记录所引出的SP波形；确定阈值时，以10dB为阶梯逐次降低刺激声强度，直至波形消失，然后再增加5dB声强，观察能否引出波形，可引出波形的最小声强为该刺激声的SP阈值。Click and short pure tones (1kHz, 2kHz, 4kHz, 8kHz, 16kHz, and 20kHz) were used to induce respectively; the stimulus sound intensity started from 90dB SPL, and the induced SP waveform was observed and recorded; when determining the threshold, the stimulus sound intensity was gradually reduced by 10dB until the waveform disappeared, and then the sound intensity was increased by 5dB to observe whether the waveform could be induced. The minimum sound intensity that could induce a waveform was the SP threshold of the stimulus sound.
诱导声参数设置：交替相位；短纯音上升下降时间为1ms，持续时间10ms,刺激频率21次/s。The induced sound parameter settings were as follows: alternating phase; the rise and fall time of short pure tone was 1 ms, the duration was 10 ms, and the stimulation frequency was 21 times/s.
波形采集设置：叠加次数100次；观察窗40ms；带通滤波高通off低通1kHz。Waveform acquisition settings: stacking times 100 times; observation window 40ms; bandpass filter high pass off low pass 1kHz.
波形分析方法：波形横轴为时间轴，纵轴为电压轴，负向波出现前的平台为基线，所采集SP波波顶与基线的差值为SP幅值。Waveform analysis method: The horizontal axis of the waveform is the time axis, the vertical axis is the voltage axis, the platform before the negative wave appears is the baseline, and the difference between the collected SP wave top and the baseline is the SP amplitude.
本发明具有以下结构创新：The present invention has the following structural innovations:
1、信号传输线盒：“S”形、“Z”形或螺旋形的信号传输线第三弯折部1-4收纳于信号传输盒内，信号传输盒的收纳设计保证传输线材长度冗余，信号传输盒的密封设计确保体内的生物相容性。1. Signal transmission box: The third bends 1-4 of the "S"-shaped, "Z"-shaped or spiral signal transmission lines are stored in the signal transmission box. The storage design of the signal transmission box ensures the redundancy of the transmission line length, and the sealing design of the signal transmission box ensures biocompatibility in the body.
2、电极形状：不同形状可适配不同的信号采集点结构，确保与信号采集点组织腔隙或结构稳妥挈合。2. Electrode shape: Different shapes can be adapted to different signal collection point structures to ensure a secure fit with the tissue cavity or structure of the signal collection point.
3、颅顶固定基座结构及创口贴设计：固定基座在为体内体外线材提供连接载体的同时，确保连接部可在颅顶稳妥固定，外力撞击不移位。创口贴的可移动设计能够确保动物生长发育所带来的颅顶软组织厚度变化。3. Skull top fixation base structure and bandage design: The fixed base provides a connection carrier for the internal and external wires, while ensuring that the connection part can be firmly fixed on the skull top and will not shift due to external impact. The removable design of the bandage can ensure the thickness changes of the skull top soft tissue caused by the growth and development of the animal.
4、信号传输线第一折弯部1-1和信号传输线第二折弯部1-2：信号传输线第一折弯部1-1为“S”形，可为近电极1的信号传输线提供长度冗余，避免线材拉动使电极移位；信号传输线第二折弯部1-2为“S”形，可与传输线卡扣一并使用，起到稳妥固定线材作用。4. The first bend 1-1 of the signal transmission line and the second bend 1-2 of the signal transmission line: The first bend 1-1 of the signal transmission line is "S" shaped, which can provide length redundancy for the signal transmission line near the electrode 1 to prevent the electrode from shifting due to pulling the wire; the second bend 1-2 of the signal transmission line is "S" shaped and can be used together with the transmission line buckle to securely fix the wire.
5、保护帽和密封圈设计：在不进行检测时，封闭信号输入端器件，确保器件工作状态，密封圈防水设计加强防护作用。5. Protective cap and sealing ring design: When not testing, the signal input device is closed to ensure the working state of the device, and the sealing ring waterproof design enhances the protective effect.
本发明具有以下性能创新：本装置实现了长期、稳定、可靠采集大动物耳蜗电图的性能创新。装置电极端有多种形状可供选择使用，实现了稳妥固定的性能创新；信号传输线盒内信号传输线的可延展设计，解决了大动物颅骨生长发育导致信号传输线拉断的问题，实现了可延展性性能创新性。The invention has the following performance innovations: the device realizes the performance innovation of long-term, stable and reliable acquisition of electrocochlear electrograms of large animals. The electrode end of the device has a variety of shapes to choose from, realizing the performance innovation of stable fixation; the extensible design of the signal transmission line in the signal transmission line box solves the problem of the signal transmission line being broken due to the growth and development of the skull of large animals, realizing the performance innovation of extensibility.
本发明具有以下材料创新：The present invention has the following material innovations:
电极1、信号传输线、信号输入端23及连接导线处导电部可采用纯银、银铜合金、纯铜表面镀金、黄金、铂金、铂铱合金、不锈钢鞘复合银质针芯等材料，电阻低导电性强，保证信号采集及传输效率。除电极外均使用绝缘层包裹。The conductive parts of the electrode 1, signal transmission line, signal input terminal 23 and connecting wires can be made of pure silver, silver-copper alloy, pure copper surface plated with gold, gold, platinum, platinum-iridium alloy, stainless steel sheath composite silver needle core and other materials, which have low resistance and strong conductivity to ensure signal collection and transmission efficiency. Except for the electrode, all parts are wrapped with an insulating layer.
最后所应说明的是，以上实施例仅用以说明本发明的技术方案而非限制。尽管参照实施例对本发明进行了详细说明，本领域的普通技术人员应当理解，对本发明的技术方案进行修改或者等同替换，都不脱离本发明技术方案的精神和范围，其均应涵盖在本发明的权利要求范围当中。Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention is described in detail with reference to the embodiments, it should be understood by those skilled in the art that any modification or equivalent replacement of the technical solutions of the present invention does not depart from the spirit and scope of the technical solutions of the present invention and should be included in the scope of the claims of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410506208.4ACN118216921A (en) | 2024-04-25 | 2024-04-25 | Device for long-term monitoring of cochlear electrogram of large animal |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410506208.4ACN118216921A (en) | 2024-04-25 | 2024-04-25 | Device for long-term monitoring of cochlear electrogram of large animal |
| Publication Number | Publication Date |
|---|---|
| CN118216921Atrue CN118216921A (en) | 2024-06-21 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410506208.4APendingCN118216921A (en) | 2024-04-25 | 2024-04-25 | Device for long-term monitoring of cochlear electrogram of large animal |
| Country | Link |
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| CN (1) | CN118216921A (en) |
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| TA01 | Transfer of patent application right | Effective date of registration:20241121 Address after:100853 Fuxing Road 28, Beijing, Haidian District Applicant after:The first medical center of PLA General Hospital Country or region after:China Applicant after:ZHEJIANG NUROTRON BIOTECHNOLOGY Co.,Ltd. Address before:100048, Fu Cheng Road, Beijing, Haidian District, No. 6 Applicant before:THE SIXTH MEDICAL CENTER OF PLA GENERAL Hospital Country or region before:China Applicant before:ZHEJIANG NUROTRON BIOTECHNOLOGY Co.,Ltd. | |
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