CN101259302A - Intelligent Brain Nerve Nucleus Electrical Stimulation System - Google Patents
Intelligent Brain Nerve Nucleus Electrical Stimulation System Download PDFInfo
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Abstract
本发明涉及一种智能脑神经核团电刺激系统。可用于手术过程中通过反馈电极周围神经的电信号帮助植入电极的定位,术后产生可以控制的电信号刺激靶向神经核团,或记录、传输和分析靶向神经核团的电信号,自动调整刺激信号序列,并监测颅内压变化。系统由植入部分、射频控制部分和体外供电部分三个部分组成。其中植入部分包括刺激信号发生以及信息处理单元、射频通讯单元、颅内压监测单元、神经信号采集单元、电极及传感器接口和供电单元六个子单元构成;射频控制部分主要由射频通讯单元、控制单元、输入输出单元信息分析处理单元和计算机接口五个子单元构成。外部供电部分主要由线圈和高频逆变电路两个子单元构成。
The invention relates to an intelligent brain nerve nucleus electrical stimulation system. It can be used to help the positioning of the implanted electrode by feeding back the electrical signal of the peripheral nerve of the electrode during the operation, and generate controllable electrical signals to stimulate the target nerve nucleus after operation, or record, transmit and analyze the electrical signal of the target nerve nucleus. Automatically adjust the stimulation signal sequence and monitor changes in intracranial pressure. The system consists of three parts: implant part, radio frequency control part and external power supply part. The implanted part consists of six subunits including stimulus signal generation and information processing unit, radio frequency communication unit, intracranial pressure monitoring unit, nerve signal acquisition unit, electrode and sensor interface, and power supply unit; the radio frequency control part is mainly composed of radio frequency communication unit, control Unit, input and output unit, information analysis and processing unit and computer interface are composed of five sub-units. The external power supply part is mainly composed of two sub-units, a coil and a high-frequency inverter circuit.
Description
技术领域 technical field
本发明涉及生物医学工程领域进行脑深部神经核团功能性电刺激的一种新型的医用植入式装置。特别涉及智能脑神经核团电刺激系统。The invention relates to a novel medical implantable device for functional electrical stimulation of deep brain nuclei in the field of biomedical engineering. In particular, it relates to an electrical stimulation system for intelligent cranial nerve nuclei.
背景技术 Background technique
脑功能性疾病是脑内核团或神经的功能异常而引起的一组临床症侯群,多数病人不伴有器质病变。主要包括各种运动障碍性疾病,颅神经综合症,癫痫,精神病,恶痛等多种疾病。Functional brain diseases are a group of clinical syndromes caused by functional abnormalities of inner groups or nerves in the brain, and most patients are not accompanied by organic diseases. It mainly includes various movement disorders, cranial nerve syndrome, epilepsy, mental illness, nausea and other diseases.
脑功能性疾病的起病原因不同,但治疗方法近似。目前使用最为普遍的是脑深部神经核团电刺激,它是近十年发展起来的治疗脑功能性疾病最有效的方式。国外已经设计并发明了相关的装置,并批准进入临床,已经实施了近2万例次植入手术,均取得了良好的疗效。国内还未曾见到相关的专利和报道,该类医疗装置目前完全依赖进口。The etiology of functional brain diseases is different, but the treatment methods are similar. At present, the most widely used method is electrical stimulation of deep brain nuclei, which is the most effective way to treat brain functional diseases developed in the past ten years. Relevant devices have been designed and invented abroad, and have been approved for clinical use. Nearly 20,000 cases of implantation operations have been performed, and good curative effects have been achieved. No relevant patents and reports have been seen in China, and this type of medical device is currently completely dependent on imports.
经过多年的临床调查和实验,我们发现脑深部刺激器作为毁损治疗的替代措施,具有明显优势,但诸多方面仍需要改进。例如:After years of clinical investigation and experiments, we found that deep brain stimulators have obvious advantages as an alternative to lesion treatment, but many aspects still need to be improved. For example:
(1)脑深部刺激器系统没有采集记录功能,不能实施神经核团的精确定位,影响疗效;缺乏可靠的病情数据采集、疗效评估及反馈控制体系,不能用于对脑疾病的深入研究。(1) The deep brain stimulator system does not have the function of collecting and recording, and cannot accurately locate the nerve nuclei, which affects the curative effect; it lacks reliable disease data collection, curative effect evaluation and feedback control system, and cannot be used for in-depth research on brain diseases.
(2)无颅内压监测装置,无法监控术后大脑的恢复情况。(2) There is no intracranial pressure monitoring device, and it is impossible to monitor the recovery of the brain after surgery.
(3)采用一次性电池供电,使用时间和强度受到电池电量的限制。无法长期选择耗电量大的高电压高频率的刺激模式,影响疗效;而且必须定期更换刺激装置。(3) It is powered by a disposable battery, and the use time and intensity are limited by the power of the battery. It is impossible to choose a high-voltage and high-frequency stimulation mode that consumes a lot of power for a long time, which will affect the curative effect; and the stimulation device must be replaced regularly.
(4)刺激器(含电池)体积过大,手术部位的选择和手术过程中的定位问题使得患者手术创面过大,且异物感也给患者造成长期的心理负担。(4) The volume of the stimulator (including the battery) is too large, the selection of the surgical site and the positioning during the operation make the surgical wound of the patient too large, and the foreign body sensation also causes long-term psychological burden to the patient.
这些都给患者带来不必要的肉体和精神上的痛苦和损伤,造成一定的经济损失。These all bring unnecessary physical and mental pain and damage to patients, causing certain economic losses.
发明内容 Contents of the invention
本发明的目的在于提供一种智能脑神经核团电刺激系统,该系统具有神经信息记录,信息分析反馈,脑内核团电刺激等功能的治疗。它能够提供不同频率、电压和脉宽的电刺激信号;能够续、动态采集和记录神经电信号,用于植入电极的定位和信息分析;能够实施监测颅内压的变化,用于监控术后大脑的恢复情况;采用经皮电磁耦合供电方式,避免受到电池电量的限制,减小了植入部分的体积。The object of the present invention is to provide an intelligent brain nucleus electrical stimulation system, which has the functions of nerve information recording, information analysis and feedback, and brain nucleus electrical stimulation. It can provide electrical stimulation signals of different frequencies, voltages and pulse widths; it can continuously and dynamically collect and record nerve electrical signals for positioning and information analysis of implanted electrodes; it can monitor changes in intracranial pressure for monitoring surgical procedures. Restoration of the posterior brain; the use of percutaneous electromagnetic coupling power supply avoids the limitation of battery power and reduces the volume of the implanted part.
本发明的技术方案是这样实现的:Technical scheme of the present invention is realized like this:
本发明包括植入部分、射频控制部分和体外供电部分,体外供电部分通过电磁耦合和植入部分的供电部分进行能量传输,两者的距离不能超过1.5cm;射频控制部分和植入部分通过射频交换信息,射频控制部分向植入部分传入工作模式命令,并接收植入部分采集的颅内压信息和神经点信号。The present invention includes an implant part, a radio frequency control part and an external power supply part. The external power supply part performs energy transmission through electromagnetic coupling and the power supply part of the implant part, and the distance between the two cannot exceed 1.5 cm; the radio frequency control part and the implant part pass radio frequency To exchange information, the radio frequency control part transmits a working mode command to the implant part, and receives intracranial pressure information and nerve point signals collected by the implant part.
所述的植入部分包括刺激信号发生以及信息处理单元、射频通讯单元、颅内压监测单元、神经信号采集单元、电极及传感器接口和供电单元;神经信号采集单元和颅内压监测单元与电极及传感器接口连接,电极及传感器及口与刺激信号发生以及信息处理单元的A/D端口连接,将采集到的信号数字化;刺激信号发生以及信息处理单元的D/A端口与电极及传感器接口连接,将产生的刺激信号序列输出至电极;刺激信号发生以及信息处理单元与射频通讯单元连接,其中供电单元通过电磁耦合接收体外供电部分传输的能量。The implant part includes stimulation signal generation and information processing unit, radio frequency communication unit, intracranial pressure monitoring unit, nerve signal acquisition unit, electrode and sensor interface and power supply unit; nerve signal acquisition unit, intracranial pressure monitoring unit and electrode Connect with the interface of the sensor, the electrode, the sensor and the mouth are connected with the stimulation signal generation and the A/D port of the information processing unit, and digitize the collected signal; the stimulation signal generation and the D/A port of the information processing unit are connected with the electrode and the sensor interface , output the generated stimulation signal sequence to the electrodes; the stimulation signal generation and information processing unit is connected with the radio frequency communication unit, wherein the power supply unit receives the energy transmitted by the external power supply part through electromagnetic coupling.
射频控制部分包括控制单元、射频通讯单元、输入输出单元、信息分析处理单元、计算机接口和供电单元;控制单元的I/O口分别与输入输出单元、信息分析处理单元、射频通讯单元连接;控制单元的JTAG调试口与计算机接口连接。The radio frequency control part includes a control unit, a radio frequency communication unit, an input and output unit, an information analysis and processing unit, a computer interface and a power supply unit; the I/O ports of the control unit are respectively connected with the input and output unit, the information analysis and processing unit, and the radio frequency communication unit; The JTAG debugging port of the unit is connected with the computer interface.
体外供电部分包括传输线圈、高频逆变和供电单元;其中供电单元与高频逆变连接,高频逆变通过匹配电容与传输线圈连接。The external power supply part includes a transmission coil, a high-frequency inverter and a power supply unit; the power supply unit is connected to the high-frequency inverter, and the high-frequency inverter is connected to the transmission coil through a matching capacitor.
输入输出单元采用直接设定或步进式搜索调整的方式调节刺激信号的频率、电压和脉宽参数。The input and output unit adjusts the frequency, voltage and pulse width parameters of the stimulation signal by direct setting or step search adjustment.
高频逆变产生频率在500kHz-1MHz的占空比为50%的方波。The high-frequency inverter generates a square wave with a frequency of 500kHz-1MHz and a duty cycle of 50%.
传输线圈采用单股平面螺旋方式绕制,并和匹配电容形成振荡回路。The transmission coil is wound in a single-strand planar spiral manner, and forms an oscillation loop with a matching capacitor.
供电单元由接收线圈、整流电路和电压调整电路构成,接收线圈与整流电路通过匹配电容连接,整流电路和电压调整电路连接。The power supply unit is composed of a receiving coil, a rectifying circuit and a voltage adjusting circuit, the receiving coil is connected to the rectifying circuit through a matching capacitor, and the rectifying circuit is connected to the voltage adjusting circuit.
供电单元的接收线圈采用多股并绕平面螺旋的方式,和匹配电容形成振荡回路。The receiving coil of the power supply unit adopts a multi-strand spiral around the plane, and forms an oscillating loop with the matching capacitor.
本发明是一种新型的可佩戴式脑深部神经核团刺激器。它适合脑功能型疾病患者长期佩戴,能对脑深部神经和团实行靶向刺激,并能动态、连续地采集相关生理和病理信息,通过对这些信息的分析处理,实现对刺激参数的反馈调节。这种系统结构构思新颖,功能独特,其主要的技术特点在于:The invention is a novel wearable deep brain nucleus stimulator. It is suitable for long-term wear by patients with brain functional diseases. It can perform targeted stimulation on deep brain nerves and groups, and can dynamically and continuously collect relevant physiological and pathological information. Through the analysis and processing of these information, the feedback adjustment of stimulation parameters can be realized. . This system has a novel structure concept and unique functions. Its main technical features are:
(1)能够采集脑电信号,实现对刺激的参数的动态反馈调节。系统能够动态、连续的采集刺激部位神经核团的电生理信息,分析处理后,主动调整电刺激信号参数,达到刺激效果的最优化。(1) It can collect EEG signals and realize the dynamic feedback adjustment of stimulation parameters. The system can dynamically and continuously collect the electrophysiological information of the nerve nuclei at the stimulation site, and after analysis and processing, actively adjust the parameters of the electrical stimulation signal to optimize the stimulation effect.
(2)能实时检测颅内压的变化,监测病人的恢复情况。(2) It can detect the change of intracranial pressure in real time and monitor the patient's recovery.
(3)实现设备的植入部分和外部供能部分的经皮能量传输,保证植入部分的稳定供电。(3) Realize the transcutaneous energy transmission between the implanted part of the device and the external energy supply part, and ensure the stable power supply of the implanted part.
(4)实现设备的植入部分和外部控制部分的信息传输,保证植入部分具有良好的可操控性,保证植入部分采集的信息能够完整地传输到控制部分并保存。(4) Realize the information transmission between the implanted part of the device and the external control part, ensure that the implanted part has good controllability, and ensure that the information collected by the implanted part can be completely transmitted to the control part and saved.
(5)系统具有良好的生物兼容性和良好的治疗效果。(5) The system has good biocompatibility and good therapeutic effect.
附图说明 Description of drawings
图1是本发明系统结构示意图。Fig. 1 is a schematic diagram of the system structure of the present invention.
图2是本发明的手术植入示意图。Fig. 2 is a schematic diagram of surgical implantation of the present invention.
图3是本发明的操作流程。Fig. 3 is the operation flow of the present invention.
具体实施方式 Detailed ways
图1所示,本发明由植入部分1、射频控制部分2和体外供电部分3三个部分组成。其中植入部分1包括刺激信号发生以及信息处理单元4、射频通讯单元5、颅内压监测单元6、神经信号采集单元7、电极及传感器接口8和供电单元9六个子单元构成;射频控制部分2主要由控制单元10、射频通讯单元11、输入输出单元12(含液晶显示和选择按键)、信息分析处理单元13、计算机接口单元14和供电单元15六个子单元构成。外部供电部分主要由传输线圈16、高频逆变17和供电单元18三个子单元构成。As shown in FIG. 1 , the present invention consists of three parts: an implant part 1 , a radio
(1)植入部分1的主要组成及功能(1) Main components and functions of the implant part 1
植入部分1以刺激发生以及信息采集单元4为核心,该单元主要由单片机MSP430F169组成。射频通讯单元5采用nRF2401通讯模块,工作频率为2.4GHz。电极及传感器接口8使用双四选一多路模拟转换开关4052,通过MSP430F169的控制,实现对电极刺激或采集位点的选择。The core of the implant part 1 is the stimulus generation and information collection unit 4, which is mainly composed of a single-chip microcomputer MSP430F169. The radio
刺激发生以及信息采集单元4通过监测射频通讯单元5的输入信号,从射频控制部分2获取工作状态参数,并选择相关电路实现其功能。如果接收的是刺激参数,则根据参数产生刺激信号序列,通过电极及传感器接口8刺激脑深部神经核团;如果接收的是采集参数,则通过电极及传感器接口8采集相应的神经核团信息或颅内压信息,A/D转换后在传输至射频控制部分2。The stimulus generation and information collection unit 4 obtains working state parameters from the radio
在刺激模式时,MSP430 F169可以根据刺激参数,选择刺激的频率、电压以及脉冲的宽度,还可以选择刺激电极的刺激位点,使得刺激定位更加准确,刺激强度更加合理,达到提高治疗效果的目的。In the stimulation mode, MSP430 F169 can select the frequency, voltage and pulse width of the stimulation according to the stimulation parameters, and can also select the stimulation site of the stimulation electrode, so that the stimulation positioning is more accurate, the stimulation intensity is more reasonable, and the purpose of improving the therapeutic effect is achieved. .
在采集模式时,MSP43 F1690可以根据采集参数,选择采集颅内压信息或神经电信号。采集颅内压信息时,颅内压监测单元6和植入在颅骨内侧面的压力传感器相连,压力传感器将颅内压力转换为电信号输出至颅内压监测单元6,经过整合后送至MSP430F169。采集神经信号时,MSP430F169将根据参数,选择相应的电极采集位点,经过神经信息采集单元7滤波、放大后送至MSP430F169。MSP430F169再将采集到的信息通过射频通讯单元5传输至射频控制部分2,以供其分析处理。In the collection mode, MSP43 F1690 can choose to collect intracranial pressure information or nerve electrical signals according to the collection parameters. When collecting intracranial pressure information, the intracranial
供电单元9由经皮能量传输系统的次级接收线圈、高频整流电路和电压调整电路组成。次级线圈采用多股并绕平板螺旋的方式增加传输的效率,并与匹配的电容构成LC振荡电路。高频整流电路将振荡变化的电压整流成直流电压;电压调整电路则根据植入部分1所有功能单元的电源要求输出合适的电压。The
(2)射频控制部分2的主要组成及功能(2) The main components and functions of the radio
射频控制部分2以控制单元10为核心,该单元主要由单片机MSP430F149组成。MSP430F149通过接收输入输出单元12的输入参数来设定整个系统的工作模式。信息分析处理单元13使用数字信号处理器TMS320VC5503作为处理芯片。计算机接口14采用TUSB2036芯片作为控制芯片。The radio
当系统处于采集信息模式时,控制单元10通过射频通讯单元11向植入部分1发出命令参数,选择采集信息的类别和采集信息时的相关参数,并通过射频通讯单元11接收所采集到的信息,然后根据指令送至控制部分中的信息分析处理单元13或通过计算机接口14送至计算机。When the system is in the information collection mode, the
当系统处于手动刺激模式时,控制单元10读取输入输出单元12的刺激参数设置,通过射频输出单元11控制植入部分1的刺激信号序列的参数。同时,手动输入模式可以按照不同的步进值来改变刺激信号的频率或电压,以方便搜索合适的刺激参数。When the system is in the manual stimulation mode, the
当系统处于自动刺激模式时,系统将采用分时复用的方式刺激或采集信息。控制单元10将工作参数送至植入部分1后,植入部分将按照设定采集参数采集颅内压和神经信息,并将信息反馈会射频控制部分2。其中的控制单元10将采集到的信息送至信息分析处理单元13,经过一定方法的分析后,调整刺激参数,再送回至植入部分1。植入部分1按照新的刺激参数刺激一定的时间后,再次采集信息。When the system is in automatic stimulation mode, the system will stimulate or collect information in a time-division multiplexing manner. After the
信息分析处理单元13主要有DSP构成,其中集成了证明科学有效的非线性分析方法。通过对输入的信息进行分析和处理,判断患者病症的类型和程度,选择最适宜的刺激参数。The information analysis and
输入输出单元12主要包括液晶显示屏和输入按键,提供人机交互的界面和方法,保障了参数选择的可视性和准确性。The input and
(3)外部供电部分3的主要组成和功能(3) Main components and functions of the external
外部供电部分3主要包括原级传输线圈16和高频逆变17构成。高频逆变17利用零电压开关-脉宽调制变换器技术,并改进其传输线圈的形式。PWM开关控制芯片选用TI公司的低功耗占空比可调PWM控制芯片UCC3807-3,开关器件选用高频开关管IRFU220,选择的工作频率在500kHz-1MHz之间。The external
原级传输线圈16采用单股平面螺旋样式,其面积较之次级接收线圈为大,可以有效提高传输效率。原级传输线圈和电容匹配,形成振荡频率和PWM开关控制芯片工作频率相同的LC振荡回路。The
图2所示。本发明植入的位置应选择颅骨顶部距离所刺激的脑深部核团距离较近的位置。与本发明配套的神经核团刺激电极23植入刺激的靶向神经核团,颅内压传感器24植入颅骨内侧面,并于本发明的植入部分1、19的电极及传感器接口8连接。本发明的外部供电部分3的传输线圈16,20贴于植入部分的头顶部皮层的外侧,和植入部分1,19的供电单元9的次级接收线圈同轴放置;高频逆变部分17,21置于耳部后方,通过导线22和传输线圈16,20连接。Figure 2 shows. The position of the implantation of the present invention should be selected at a position close to the stimulated deep brain nucleus from the top of the skull. The nerve nucleus stimulating electrode 23 supporting the present invention is implanted into the stimulated targeted nerve nucleus, and the intracranial pressure sensor 24 is implanted on the inner side of the skull, and is connected to the electrodes and the sensor interface 8 of the implanted parts 1, 19 of the present invention . The
图3所示。打开外部供电部分3的开关后,植入部分1电路启动待机。打开射频控制部分2,调整工作参数后,通过射频遥控植入部分1工作。可根据需要通过将射频控制能部分2通过USB接口和计算机连接,采集需要的神经电信号和颅内压信号,使用配套的软件进行记录、分析和处理后,将所得的参数传回射频控制部分,用以调节植入部分的刺激信号序列。Figure 3 shows. After the switch of the external
系统的一个实施例。当使用采集信号工作模式时,射频控制部分2将采集的信号类型和电极采集位点的选择等参数通过射频11传输给植入部分1,植入部分1选择合适的通道8采集相应的信号,并通过射频5回传给射频控制部分2,射频控制部分2可以将采集到的信号传输至信号分析处理单元13,或经过计算机接口14传输至外部计算机。An embodiment of the system. When using the acquisition signal working mode, the radio
系统的另一个实施例。当使用手动刺激工作模式时,须通过输入输出单元12手动设置刺激信号的频率、电压以及脉宽等参数,如不设置则使用上次刺激时的参数。射频控制部分2将所设定的参数传输至植入部分1,植入部分1根据得到的参数进行电刺激。当需要选择刺激参数时,可以设定选择的某一参数的初始值和步进值,则开始刺激后,选定的刺激参数会按照设定的步进值变化,达到较好的刺激效果时,点击确定,可以选择此刻的刺激参数为默认的刺激参数。Another embodiment of the system. When the manual stimulation mode is used, parameters such as the frequency, voltage and pulse width of the stimulation signal must be manually set through the input and
系统的另一个实施例。当使用自动刺激工作模式时,植入部分1首先开始采集颅内压和神经电信号6,7,8,并传输至射频控制部分2,经过其中的信号分析处理单元13的分析,将选定一定的刺激参数,该参数传回至植入部分1,植入部分1按照此参数刺激一定的时间后,重新采集颅内压和神经电信号6,7,8并反馈回射频控制部分2。通过这样的程序,达到了自动控制刺激信号序列的目的。Another embodiment of the system. When using the automatic stimulation working mode, the implant part 1 first starts to collect the intracranial pressure and nerve
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