CN102457252A - double-channel pulse generator and implantable electrical stimulation system - Google Patents
double-channel pulse generator and implantable electrical stimulation system Download PDFInfo
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- CN102457252A CN102457252A CN2010105172792A CN201010517279A CN102457252A CN 102457252 A CN102457252 A CN 102457252A CN 2010105172792 A CN2010105172792 A CN 2010105172792A CN 201010517279 A CN201010517279 A CN 201010517279A CN 102457252 A CN102457252 A CN 102457252A
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Abstract
Description
技术领域 technical field
本发明涉及植入式医疗器械,尤其是双通道独立可调控输出的脉冲发生器及植入式电刺激系统。The invention relates to an implantable medical device, in particular to a pulse generator with dual-channel independently adjustable output and an implantable electrical stimulation system.
背景技术 Background technique
现有技术中,植入式电刺激系统及植入式药物输送系统作为治疗或预防疾病的一种手段获得了越来越广泛的应用。植入式电刺激系统通常包括植入式心脏电刺激系统(俗称心脏起搏器)和植入式神经电刺激系统,主要包括植入体内的脉冲发生器、电极以及体外的控制装置。其中,脉冲发生器与电极相连接,从而将脉冲发生器所产生的脉冲传输到电极,脉冲发生器产生的脉冲信号由电极传输至心脏或特定神经部位进行电刺激,从而使人体机能恢复到正常运作的状态。In the prior art, implantable electrical stimulation systems and implantable drug delivery systems have been used more and more widely as a means of treating or preventing diseases. Implantable electrical stimulation systems usually include implantable cardiac electrical stimulation systems (commonly known as cardiac pacemakers) and implantable nerve electrical stimulation systems, mainly including implanted pulse generators, electrodes and external control devices. Among them, the pulse generator is connected to the electrode, so that the pulse generated by the pulse generator is transmitted to the electrode, and the pulse signal generated by the pulse generator is transmitted from the electrode to the heart or specific nerve parts for electrical stimulation, so that the human body function returns to normal state of operation.
已知的植入式神经电刺激系统通常主要包括脉冲发生器、电极、延伸导线、以及体外控制装置。其中,脉冲发生器与延伸导线连接,延伸导线进而又连接至电极,从而将脉冲发生器所产生的脉冲传输到电极,以对神经进行电刺激。Known implantable electrical nerve stimulation systems generally mainly include pulse generators, electrodes, extension leads, and external control devices. Wherein, the pulse generator is connected to the extension wire, and the extension wire is further connected to the electrode, so that the pulse generated by the pulse generator is transmitted to the electrode to electrically stimulate the nerve.
植入式双通道脉冲发生器是指脉冲发生器具有两路刺激输出分别对大脑左右两侧进行刺激,实现治疗效果。现有技术中的双通道脉冲发生器的两个通道的刺激频率必须相同,无法分别调控,研究表明大脑左右两侧使用同一频率的刺激模式效果不理想,因此如何实现双通道脉冲发生器的所有刺激参数(包括频率、脉宽、幅值及刺激模式)均可独立调节控制,使得大脑左右两侧的神经调控达到最优效果是亟待解决的问题。The implantable dual-channel pulse generator means that the pulse generator has two stimulation outputs to stimulate the left and right sides of the brain respectively to achieve therapeutic effects. The stimulation frequency of the two channels of the dual-channel pulse generator in the prior art must be the same and cannot be adjusted separately. Studies have shown that the effect of using the same frequency stimulation mode on the left and right sides of the brain is not ideal. Therefore, how to realize all the functions of the dual-channel pulse generator Stimulation parameters (including frequency, pulse width, amplitude and stimulation mode) can be independently adjusted and controlled, so that the optimal effect of neural regulation on the left and right sides of the brain is an urgent problem to be solved.
发明内容 Contents of the invention
针对现有技术中存在的不足,本发明要解决的技术问题是提供一种能够对脉冲发生器的两个通道分别实现独立调节控制的双通道脉冲发生器及植入式电刺激系统。In view of the deficiencies in the prior art, the technical problem to be solved by the present invention is to provide a dual-channel pulse generator and an implantable electrical stimulation system capable of independently adjusting and controlling the two channels of the pulse generator.
根据本发明所提供的技术方案,一种双通道脉冲发生器,包括微处理器模块和双通道电刺激电路模块,所述微处理器模块用于接收体外程控器发出的调控命令并传送给所述电刺激电路模块,所述电刺激电路模块包括可分别独立调控输出的第一刺激脉冲输出通道和第二刺激脉冲输出通道。According to the technical solution provided by the present invention, a dual-channel pulse generator includes a microprocessor module and a dual-channel electrical stimulation circuit module. The electrical stimulation circuit module includes a first stimulation pulse output channel and a second stimulation pulse output channel that can independently regulate the output.
优选地,所述双通道电刺激电路模块为双通道电刺激数模混合芯片。Preferably, the dual-channel electrical stimulation circuit module is a dual-channel electrical stimulation digital-analog hybrid chip.
优选地,所述可分别独立调控输出包括刺激脉冲的频率、脉宽、幅值、刺激模式。Preferably, the independently adjustable outputs include frequency, pulse width, amplitude and stimulation mode of stimulation pulses.
优选地,所述的微处理器模块包括CPU、存储器、第一通讯模块;Preferably, the microprocessor module includes a CPU, a memory, and a first communication module;
所述电刺激数模混合芯片包括通过通讯总线与所述第一通讯模块相连接的第二通讯模块;The electrical stimulation digital-analog hybrid chip includes a second communication module connected to the first communication module through a communication bus;
所述第一刺激脉冲输出通道包括与所述第二通讯模块依次相连接的第一通道寄存器存储模块、第一通道数字脉冲发生器、第一通道模拟脉冲发生器、第一通道输出控制模块;The first stimulation pulse output channel includes a first channel register storage module, a first channel digital pulse generator, a first channel analog pulse generator, and a first channel output control module sequentially connected to the second communication module;
所述第二刺激脉冲输出通道包括与所述第二通讯模块依次相连接的第二通道寄存器存储模块、第二通道数字脉冲发生器、第二通道模拟脉冲发生器、第二通道输出控制模块。The second stimulation pulse output channel includes a second channel register storage module, a second channel digital pulse generator, a second channel analog pulse generator, and a second channel output control module that are sequentially connected to the second communication module.
优选地,所述电刺激数模混合芯片包括用于产生独立可调控的数字刺激调控信号输出的数字电路模块和用于将上述数字刺激调控信号转换为模拟刺激信号输出的模拟电路模块;Preferably, the electric stimulation digital-analog hybrid chip includes a digital circuit module for generating an independently adjustable digital stimulation regulation signal output and an analog circuit module for converting the digital stimulation regulation signal into an analog stimulation signal output;
所述数字电路模块包括所述的第二通讯模块、与所述第二通讯模块相连接的第一通道寄存器存储模块和第二通道寄存器存储模块、与所述第一通道寄存器存储模块相连接用于产生第一通道指定频率、脉宽、幅值和刺激模式的第一通道数字脉冲发生器、与所述第二通道寄存器存储模块相连接用于产生第二通道指定频率、脉宽、幅值和刺激模式的第二通道数字脉冲发生器;The digital circuit module includes the second communication module, a first channel register storage module and a second channel register storage module connected to the second communication module, and a channel register storage module connected to the first channel register storage module. The first channel digital pulse generator for generating the specified frequency, pulse width, amplitude and stimulation mode of the first channel is connected with the second channel register storage module for generating the specified frequency, pulse width and amplitude of the second channel and a second channel digital pulse generator in stimulation mode;
所述模拟电路模块包括与所述第一通道数字脉冲发生器相连接的第一通道模拟脉冲发生器、与所述第二通道数字脉冲发生器相连接的第二通道模拟脉冲发生器、与所述第一通道模拟脉冲发生器相连接的第一通道输出控制模块、与所述第二通道模拟脉冲发生器相连接的第二通道输出控制模块。The analog circuit module includes a first channel analog pulse generator connected to the first channel digital pulse generator, a second channel analog pulse generator connected to the second channel digital pulse generator, and the A first channel output control module connected to the first channel analog pulse generator, and a second channel output control module connected to the second channel analog pulse generator.
优选地,所述的指定的刺激模式为连续刺激模式、簇发刺激模式、定时刺激模式、运动刺激模式、软刺激模式中的一种。Preferably, the designated stimulation mode is one of continuous stimulation mode, burst stimulation mode, timed stimulation mode, motion stimulation mode and soft stimulation mode.
本发明提供了一种包括如上所述的双通道脉冲发生器的植入式神经电刺激系统。The present invention provides an implantable electrical nerve stimulation system comprising the above-mentioned dual-channel pulse generator.
优选地,所述植入式神经电刺激系统为植入式脑深部电刺激系统、植入式脑皮层电刺激系统、植入式脊髓电刺激系统、植入式骶神经电刺激系统或植入式迷走神经电刺激系统中的一种。Preferably, the implanted electrical nerve stimulation system is an implanted deep brain electrical stimulation system, an implanted cortical electrical stimulation system, an implanted spinal cord electrical stimulation system, an implanted sacral nerve electrical stimulation system or an implanted One of the electrical vagus nerve stimulation systems.
本发明还提供了一种植入式心脏起搏系统和植入式心脏复律除颤系统,包括如上所述的双通道脉冲发生器,能够分别对脉冲发生器的两个通道进行独立调节控制。The present invention also provides an implantable cardiac pacing system and an implantable cardioverter-defibrillation system, comprising the above-mentioned dual-channel pulse generator, capable of independently adjusting and controlling the two channels of the pulse generator.
与现有技术相比本发明的优点是:由于本发明的电刺激数模混合芯片包括可分别独立调控输出的第一刺激脉冲输出通道和第二刺激脉冲输出通道,使得电刺激数模混合芯片能够对体外程控器的发送的调控命令进行处理,分别经第一刺激脉冲输出通道和第二刺激脉冲输出通道实现独立的调控输出,实现医生能够对双通道脉冲发生器的两个通道的刺激输出(频率、脉宽、幅值及刺激模式)独立可调控,使病人大脑左右两侧的神经调控达到最优效果。Compared with the prior art, the advantages of the present invention are: since the electrical stimulation digital-analog hybrid chip of the present invention includes a first stimulation pulse output channel and a second stimulation pulse output channel that can independently regulate the output, the electrical stimulation digital-analog hybrid chip It can process the control commands sent by the in vitro program controller, realize independent control output through the first stimulation pulse output channel and the second stimulation pulse output channel, and realize that the doctor can stimulate the output of the two channels of the dual-channel pulse generator (Frequency, pulse width, amplitude and stimulation mode) can be adjusted independently, so that the neural regulation on the left and right sides of the patient's brain can achieve the best effect.
附图说明 Description of drawings
附图1为本发明的模块原理图;
附图2为本发明的脉冲发生器的模块原理图;
附图3为本发明的微处理器芯片及电刺激数模混合芯片的模块原理图。Accompanying
其中:in:
1、脉冲发生器;11、微处理器芯片;111、第一通讯模块;12、电刺激数模混合芯片;121、第二通讯模块;122、第一通道寄存器存储模块;123、第一通道数字脉冲发生器;124、第一通道模拟脉冲发生器;125、第一通道输出控制模块;126、第二通道寄存器存储模块;127、第二通道数字脉冲发生器;128、第二通道模拟脉冲发生器;129、第二通道输出控制模块;13、无线通讯模块;14、电源;15、第一刺激脉冲输出通道;16、第二刺激脉冲输出通道;17、数字电路模块;18、模拟电路模块;2、电极;3、体外程控器。1. Pulse generator; 11. Microprocessor chip; 111. First communication module; 12. Electric stimulation digital-analog hybrid chip; 121. Second communication module; 122. First channel register storage module; 123. First channel Digital pulse generator; 124, first channel analog pulse generator; 125, first channel output control module; 126, second channel register storage module; 127, second channel digital pulse generator; 128, second channel analog pulse Generator; 129, second channel output control module; 13, wireless communication module; 14, power supply; 15, first stimulation pulse output channel; 16, second stimulation pulse output channel; 17, digital circuit module; 18, analog circuit module; 2. electrode; 3. external program controller.
具体实施方式 Detailed ways
下面结合附图对本发明作进一步详细的说明:Below in conjunction with accompanying drawing, the present invention is described in further detail:
参照图1,一种双通道独立可调控的植入式神经电刺激系统,包括植入病人体内的脉冲发生器1、电极2、体外程控器3。脉冲发生器1与电极2电连接,从而将脉冲发生器1所产生的脉冲传输到电极2,以对神经靶点进行电刺激,达到治疗的效果。体外程控器3可与脉冲发生器1通过电磁线圈或者无线通信模块进行通信,从而调节脉冲发生器1的各种输出参数。Referring to FIG. 1 , a two-channel independently adjustable implantable electrical nerve stimulation system includes a
参照图2,以双通道独立可调控的植入式脑深部电刺激系统为例,包括植入病人的胸肋面皮下组织内的双通道脉冲发生器1、植入脑深部的与脉冲发生器1相连接的电极2,脉冲发生器1包括微处理器模块、与微处理器模块相连接的电刺激电路模块、无线通讯模块13以及为上述模块供电的电源14。Referring to Figure 2, taking the dual-channel independently adjustable implantable deep brain electrical stimulation system as an example, it includes a dual-
所述微处理器模块用于接收体外程控器发出的调控命令并传送给所述电刺激电路模块,所述电刺激电路模块包括可分别独立调控输出的第一刺激脉冲输出通道15和第二刺激脉冲输出通道16。本实施方式中,所述微处理器模块为微处理器芯片11,所述双通道电刺激电路模块为双通道电刺激数模混合芯片12。The microprocessor module is used to receive the control commands issued by the in vitro program controller and send them to the electrical stimulation circuit module, which includes the first stimulation pulse output channel 15 and the second stimulation pulse output channel 15 which can independently control the output respectively. Pulse output channel 16. In this embodiment, the microprocessor module is a
第一刺激脉冲输出通道15和第二刺激脉冲输出通道16可分别独立调控的输出包括刺激脉冲的频率、脉宽、幅值、刺激模式。第一刺激脉冲输出通道15和第二刺激脉冲输出通道16的输出参数可以是完全相同也可以是不同的。The output that can be independently adjusted by the first stimulation pulse output channel 15 and the second stimulation pulse output channel 16 includes the frequency, pulse width, amplitude and stimulation mode of the stimulation pulse. The output parameters of the first stimulation pulse output channel 15 and the second stimulation pulse output channel 16 may be completely the same or different.
参照图3,所述的微处理器模块包括CPU、存储器、第一通讯模块111,所述电刺激数模混合芯片12包括通过通讯总线与所述第一通讯模块111相连接的第二通讯模块121。With reference to Fig. 3, described microprocessor module comprises CPU, memory, first communication module 111, and described electrical stimulation digital-
所述第一刺激脉冲输出通道15包括与所述第二通讯模块121依次相连接的第一通道寄存器存储模块122、第一通道数字脉冲发生器123、第一通道模拟脉冲发生器124、第一通道输出控制模块125。The first stimulation pulse output channel 15 includes a first channel register storage module 122 sequentially connected to the second communication module 121, a first channel digital pulse generator 123, a first channel analog pulse generator 124, a first channel Channel output control module 125 .
所述第二刺激脉冲输出通道16包括与所述第二通讯模块121依次相连接的第二通道寄存器存储模块126、第二通道数字脉冲发生器127、第二通道模拟脉冲发生器128、第二通道输出控制模块129。The second stimulation pulse output channel 16 includes a second channel register storage module 126 connected in sequence with the second communication module 121, a second channel digital pulse generator 127, a second channel analog pulse generator 128, a second channel Channel output control module 129 .
本实施方式中第一通讯模块111为SPI发送模块,第二通讯模块121为SPI接收模块,SPI发送模块与SPI接收模块通过SPI总线相连接用于串行双向通讯。在其余实施方式中,可使用其他总线通讯方式实现微处理器芯片11与电刺激数模混合芯片12的通讯。In this embodiment, the first communication module 111 is an SPI sending module, and the second communication module 121 is an SPI receiving module. The SPI sending module and the SPI receiving module are connected through the SPI bus for serial two-way communication. In other embodiments, other bus communication methods can be used to realize the communication between the
所述电刺激数模混合芯片12包括用于产生独立可调控的数字刺激调控信号输出的数字电路模块17和用于将上述数字刺激调控信号转换为模拟刺激信号输出的模拟电路模块18。The electric stimulation digital-
所述数字电路模块17包括所述的第二通讯模块121、与所述第二通讯模块121相连接的第一通道寄存器存储模块122和第二通道寄存器存储模块126、与所述第一通道寄存器存储模块122相连接用于产生第一通道指定频率、脉宽、幅值和刺激模式的第一通道数字脉冲发生器123、与所述第二通道寄存器存储模块126相连接用于产生第二通道指定频率、脉宽、幅值和刺激模式的第二通道数字脉冲发生器127;The digital circuit module 17 includes the second communication module 121, the first channel register storage module 122 and the second channel register storage module 126 connected with the second communication module 121, and the first channel register storage module 126 connected with the second communication module 121. The storage module 122 is connected to the first channel digital pulse generator 123 for generating the specified frequency, pulse width, amplitude and stimulation mode of the first channel, and is connected to the second channel register storage module 126 for generating the second channel A second channel digital pulse generator 127 specifying frequency, pulse width, amplitude and stimulation mode;
所述模拟电路模块18包括与所述第一通道数字脉冲发生器123相连接的第一通道模拟脉冲发生器124、与所述第二通道数字脉冲发生器127相连接的第二通道模拟脉冲发生器128、与所述第一通道模拟脉冲发生器124相连接的第一通道输出控制模块125、与所述第二通道模拟脉冲发生器128相连接的第二通道输出控制模块129。Described analog circuit module 18 comprises the first channel analog pulse generator 124 that is connected with described first channel digital pulse generator 123, the second channel analog pulse generator that is connected with described second channel digital pulse generator 127 128 , a first channel output control module 125 connected to the first channel analog pulse generator 124 , and a second channel output control module 129 connected to the second channel analog pulse generator 128 .
所述的指定的刺激模式为连续刺激模式、簇发刺激模式、定时刺激模式、运动刺激模式、软刺激模式中的一种。所述定时刺激模式是指可在程序设定的时间间隔内循环神经刺激器中已有刺激程序的开启和关闭状态,软刺激模式是指能够软开启和软停止,即当开启刺激时允许脉冲幅度缓慢上升直到程序设定的允许的值,当刺激关闭时允许脉冲幅度缓慢降低到0。The designated stimulation mode is one of continuous stimulation mode, burst stimulation mode, timing stimulation mode, motion stimulation mode and soft stimulation mode. The timing stimulation mode refers to the opening and closing state of the existing stimulation program in the neural stimulator that can be cycled within the time interval set by the program. The soft stimulation mode refers to the ability to soft open and soft stop, that is, when the stimulation is turned on, pulses are allowed The amplitude is slowly ramped up to the programmed allowable value, and the pulse amplitude is allowed to slowly decrease to 0 when the stimulus is turned off.
本发明提供了一种包括如上所述的双通道独立可调控的脉冲发生器的植入式神经电刺激系统。根据治疗疾病的不同所述植入式神经电刺激系统可为植入式脑深部电刺激系统、植入式脑皮层电刺激系统、植入式脊髓电刺激系统、植入式骶神经电刺激系统或植入式迷走神经电刺激系统中的一种。The present invention provides an implantable electrical nerve stimulation system comprising the above-mentioned double-channel independently adjustable pulse generator. According to different diseases to be treated, the implanted electrical nerve stimulation system can be implanted deep brain electrical stimulation system, implanted cerebral cortex electrical stimulation system, implanted spinal cord electrical stimulation system, implanted sacral nerve electrical stimulation system Or one of the Implantable Vagus Nerve Stimulation Systems.
本发明还提供了一种植入式心脏起搏系统和植入式心脏复律除颤系统,包括如上所述的双通道脉冲发生器,能够分别对脉冲发生器的两个通道进行独立调节控制。The present invention also provides an implantable cardiac pacing system and an implantable cardioverter-defibrillation system, comprising the above-mentioned dual-channel pulse generator, capable of independently adjusting and controlling the two channels of the pulse generator.
使用本发明双通道独立可独立调节控制输出的脉冲发生器,医生可通过体外程控器通过无线通讯模块13将调控命令输入微处理器芯片11进行处理,由第一通讯模块111经SPI总线进入第二通讯模块121,然后分别存储于第一通道寄存器存储模块122和第二通道寄存器存储模块126。Using the dual-channel pulse generator of the present invention that can independently adjust the control output, the doctor can input the regulation command into the
第一通道寄存器存储模块122将第一通道调控命令传送给第一通道数字脉冲发生器123用于产生独立可调控的数字刺激调控信号输出,第一通道数字脉冲发生器123将数字刺激调控信号传送给第一通道模拟脉冲发生器124转换为模拟刺激信号,第一通道模拟脉冲发生器124将模拟刺激信号传送给第一通道输出控制模块125输出刺激。The first channel register storage module 122 transmits the first channel control command to the first channel digital pulse generator 123 for generating an independently adjustable digital stimulus control signal output, and the first channel digital pulse generator 123 transmits the digital stimulus control signal The first channel analog pulse generator 124 is converted into an analog stimulation signal, and the first channel analog pulse generator 124 transmits the analog stimulation signal to the first channel output control module 125 to output stimulation.
同样地,第二通道寄存器存储模块126将第二通道调控命令传送给第二通道数字脉冲发生器127用于产生独立可调控的数字刺激调控信号输出,第二通道数字脉冲发生器127将数字刺激调控信号传送给第二通道模拟脉冲发生器128转换为模拟刺激信号,第二通道模拟脉冲发生器128将模拟刺激信号传送给第二通道输出控制模块129输出刺激。Similarly, the second channel register storage module 126 transmits the second channel control command to the second channel digital pulse generator 127 for generating an independently adjustable digital stimulus control signal output, and the second channel digital pulse generator 127 outputs the digital stimulus The control signal is sent to the second channel analog pulse generator 128 for conversion into an analog stimulation signal, and the second channel analog pulse generator 128 sends the analog stimulation signal to the second channel output control module 129 to output stimulation.
与现有技术相比,本发明的电刺激数模混合芯片12包括可分别独立调控输出的第一刺激脉冲输出通道15和第二刺激脉冲输出通道16,使得电刺激数模混合芯片12能够对体外程控器的发送的调控命令进行处理,分别经第一刺激脉冲输出通道15和第二刺激脉冲输出通道16实现独立的调控输出,实现医生能够对双通道脉冲发生器的两个通道的频率、脉宽、幅值及刺激模式等刺激输出均可独立调控,使病人大脑左右两侧的神经调控达到最优效果。Compared with the prior art, the electrical stimulation digital-
本发明还可有其他多种实施例,在不背离本发明精神及实质的情况下,本领域的技术人员可根据本发明作出各种相应的改变和变形,但这些相应的改变和变形都应属于本发明的权利要求保护的范围。The present invention also can have other various embodiments, without departing from the spirit and essence of the present invention, those skilled in the art can make various corresponding changes and deformations according to the present invention, but these corresponding changes and deformations should be Belong to the protection scope of the claims of the present invention.
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