CN104548349A - Electric pulse stimulation testing device and testing system with electric pulse stimulation testing device - Google Patents

Electric pulse stimulation testing device and testing system with electric pulse stimulation testing device Download PDF

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CN104548349A
CN104548349A CN201410849257.4A CN201410849257A CN104548349A CN 104548349 A CN104548349 A CN 104548349A CN 201410849257 A CN201410849257 A CN 201410849257A CN 104548349 A CN104548349 A CN 104548349A
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stimulation
pulse
frequency
hz
electrical
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CN201410849257.4A
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李路明
加福民
钱星
万森
郝红伟
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清华大学
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Abstract

The invention relates to an electric pulse stimulation testing device which comprises an in-vitro testing stimulator and a testing wire. The in-vitro testing stimulator comprises a pulse generation module which at least can generate frequency conversion stimulation pulse signals. The frequency conversion stimulation pulse signals comprise at least two types of multiple pulse string periods formed by alternate stimulation of electric stimulation pulse strings at different frequencies. The duration of the electric stimulation pulse strings at each frequency within the corresponding pulse string period ranges from 0.1 s to 30 min. The invention further relates to an electric pulse stimulation testing system with the electric pulse stimulation testing device. By the adoption of the electric pulse stimulation testing device or the testing system, the frequency conversion stimulation pulse signals are introduced and whether a patient is suitable for treatment conducted through the frequency conversion stimulation pulse signals or not can be tested.

Description

-种电脉冲刺激测试装置w及采用该装置的测试系统 - kind of electrical stimulation test apparatus of the test system and the use of w means

技术领域 FIELD

[0001] 本发明属于微型医疗器械领域,特别涉及一种医疗使用的植入式电脉冲刺激系统,一种电脉冲刺激测试系统W及采用该植入式电脉冲刺激系统刺激神经组织的方法。 [0001] The present invention belongs to the field of medical devices microcomputer, and more particularly to an implantable electrical stimulation system for medical use, an electrical pulse stimulation test system and method of the W implantable electrical stimulation system to stimulate the nerve tissue.

背景技术 Background technique

[0002] 植入式医疗仪器种类很多,如也脏起搏器和除颤器、植入式神经刺激器、植入式肌肉刺激器等。 [0002] Many types of implantable medical devices, such as pacemakers and defibrillators are also dirty, implantable nerve stimulators, implantable muscle stimulators and so on. 植入式医疗仪器一般包含体内植入装置和体外控制装置,两者之间通过双向无线通讯交换信息。 The implantable medical device implanted device generally comprises a control means in vivo and in vitro, via a bidirectional exchange of information between the wireless communication.

[0003] 在现有的技术中,植入式医疗仪器一般利用电池供电,发出特定频率的刺激脉冲, 对特定的祀点进行长期刺激,从而改善患者的症状。 [0003] In the conventional art, an implantable medical device using a battery-powered ships, emits stimulation pulses with a specific frequency, long-term stimulation of a specific point of Si, thereby improving the patient's symptoms. 此刺激模式称作恒频刺激模式。 This mode is referred to as a constant frequency stimulation stimulation pattern. 在恒频刺激模式下,单一频率对祀点的刺激时间通常持续几天W上,几个月,甚至几年。 In constant-frequency stimulation mode, single frequency point of worship stimulation usually last a few days on the W, months, even years. 但是临床来看,现有的刺激方法对某些症状的效果不佳且会产生一定适应性。 However clinical point of view, conventional stimulation methods and poor adaptability to produce some effect of certain symptoms. 例如,针对帕金森症状的深脑刺激,在恒定频率的刺激下,对语言障碍、起步困难等不良症状改善不大。 For example, deep brain stimulation for Parkinson's symptoms at a constant frequency of stimulation, language barriers, difficulties and other adverse symptoms start small. 另外,根据对抗帕金森及癒痛患者的神经电刺激治疗经验,患者在恒定频率的刺激下,容易对刺激产生适应性,使得治疗效果变差,该类似于对长期重复使用药物产生的抗药性。 Further, according to the anti-Parkinsonian and more nerve stimulation therapy experience pain in patients, the patient at a constant frequency of stimulation, stimulation adaptability prone, such that the therapeutic effect of variation, which is similar to resistance to long-term repeated use of drugs produced .

[0004] 而且,目前植入式医疗仪器的使用方法通常是通过手术将刺激电极(包含或不包含延长导线)、脉冲发生器都植入到人体内,待手术后恢复几周时间,再打开脉冲发生器进行刺激,观察和评估刺激效果。 [0004] Moreover, the current use of implantable medical devices are usually surgically stimulation electrodes (with or without extension lead), the pulse generator are implanted into the human body, after recovery from surgery until several weeks, then open a pulse generator to stimulate the stimulatory effects observed and evaluated. 然而部分患者存在症状改善不明显或无改善的情况,此时需取出植入物。 However, there are some patients where no improvement or no significant improvement in symptoms, in which case need to remove the implant. 实际上对于观察和评估刺激效果,长期植入使用的脉冲发生器和延长导线不是必须的,而植入两个组件所需的手术操作对患者造成较大的身体损害。 In fact, for observation and evaluation of the effect of stimulating long-term use of an implantable pulse generator and an extension lead is not required, and the implant surgical procedure required two components cause greater damage to the patient's body. 因此,对于该一部分患者而言,当前手术模式存在有两个弊端,一是器械的浪费,二是手术的过度使用。 Therefore, for the part of the patient, the current mode of operation there are two drawbacks, one is a waste of equipment, the second is the excessive use of surgery.

[0005] 为了避免上述弊端,有人提出采用电脉冲刺激测试系统先对患者进行观察和评估。 [0005] In order to avoid the above drawbacks, it was suggested that use of electrical stimulation to the patient test system observed and evaluated. 例如,先仅在患者体内植入刺激电极,然后将该刺激电极与一电脉冲刺激测试系统电连接。 For example, only the first stimulation electrode implanted in the patient, then a stimulation electrode and is electrically connected to electrical pulse stimulation test system. 通过该电脉冲刺激测试系统进行测试,并观察和评估W确定该患者是否适合电刺激疗法。 Tested by electrical stimulation of the test system, and to observe and evaluate the patient to determine whether W for electrical stimulation. 然而,现有的电脉冲刺激测试系统仅能对单一频率的恒频刺激模式进行测试。 However, conventional electrical pulse stimulation test system to test only a single frequency of stimulation constant frequency mode.

发明内容 SUMMARY

[0006] 有鉴于此,确有必要提供一种可W实现变频刺激的电脉冲刺激测试装置及测试系统。 [0006] In view of this, necessary to provide a W electrical stimulation pulse frequency stimulation test apparatus and test system.

[0007] -种电脉冲刺激测试装置,其包括;一体外测试刺激器W及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其中,所述脉冲发生模块至少可W产生变频刺激脉冲信号,该变频刺激脉冲信号包括至少两种不同频率的电刺激脉冲串交替刺激形成多个脉冲串周期,且每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为0. 1砂~30分钟。 [0007] - Test Species electrical stimulation device comprising; an outer one, and W is a test stimulus test leads, and the in vitro test stimulator comprises a pulse generating modules, wherein at least said pulse generating module may generate frequency stimulation W pulse signal, the pulse frequency stimulation signal comprises at least two different frequencies of electrical stimulation pulse train alternately stimulate the formation of a plurality of burst periods, and the frequency of each electrical stimulation burst duration of each burst cycle time is zero. sand 1 to 30 minutes.

[000引每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为3砂〜60砂。 [000 electrical stimulation lead of each frequency burst duration of each burst cycle time is 3 ~ 60 Sand Sand.

[0009] 每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为5砂〜30砂。 [0009] Each electrical stimulation frequency in the burst duration of each burst cycle time of 5 ~ 30 sand sand.

[0010] 所述电刺激脉冲串的频率为30赫兹〜250赫兹。 [0010] The electrical stimulation burst frequency of 30 Hz ~ 250 Hz.

[0011] 所述电刺激脉冲串的频率为50赫兹〜150赫兹。 [0011] The electrical stimulation burst frequency of 50 Hz ~ 150 Hz.

[0012] 所述不同频率的电刺激脉冲串的个数为N,且2《N<10。 The [0012] Electrical stimulation burst frequency number N, and 2 "N <10.

[0013] 所述不同频率的电刺激脉冲串的个数为2或3,且所述不同频率的电刺激脉冲串在每个脉冲串周期中的时间比大于20%。 [0013] The number of different frequencies of electrical stimulation pulse train is 2 or 3, and the different frequencies of electrical stimulation pulse train in each burst cycle time of greater than 20%.

[0014] 所述不同频率的电刺激脉串之间间隔一定时间,且相邻两个不同频率的电刺激脉冲串之间的时间间隔为0. 01砂~60砂。 [0014] The time intervals between the electrical stimulation pulse train with different frequencies and two different frequencies between adjacent electrical stimulation burst time interval 0.01 to 60 sand sand.

[0015] 所述多个脉冲串周期之间间隔一定时间,且相邻两个脉冲串周期之间的时间间隔为0. 01砂〜60砂。 [0015] The time intervals between the plurality of burst periods, and the time interval between adjacent two burst period spacing of 0.01 ~ 60 sand sand.

[0016] 所述脉冲发生模块具有扫频功能;当设定该扫频范围为Flmin〜Flmax,扫频精度为S1,扫描时间为T1,所述脉冲发生模块将W Flmin、Flmin+Sl、Flmin+2Sl、Flmin+3Sl… Flmin+nSl、W及Flmax分别输出一电刺激脉冲串,且每个电刺激脉冲串持续时间为T1,其中,n为自然数,且n《(Flmax-Flmin) /S1。 [0016] The pulse generating module having a sweep function; when the frequency sweep range is set Flmin~Flmax, sweep accuracy as S1, the scan time is T1, the pulse generator module W Flmin, Flmin + Sl, Flmin + 2Sl, Flmin + 3Sl ... Flmin + nSl, W and Flmax outputs an electrical stimulation pulse trains, and each electrical stimulation burst duration is T1, where, n-is a natural number, and n "(Flmax-Flmin) / S1 .

[0017] 所述脉冲发生模块具有扫频功能;当设定该扫频范围为巧min〜F2max,扫频精度为S2,扫描时间为T2,所述脉冲发生模块将W巧min和巧max、巧min+S2和巧max-S2、 F2min+2S2和巧max-2S2… W及巧min+nS2和F2max-nS2分别交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T2,其中,n为自然数,且n< (F2max-巧min)/2S2。 [0017] The pulse generating module having a sweep function; when the frequency sweep range is set clever min~F2max, accuracy is swept S2, the scan time is T2, the pulse generator module clever W min and clever max, and Qiao Qiao min + S2 max-S2, F2min + 2S2 and clever and max-2S2 ... W min + nS2 coincidence F2max-nS2 and alternately outputs two electrical stimulation pulse trains, and each of the two electrical stimulation pulse train output alternately duration T2, where, n-is a natural number and n <(F2max- clever min) / 2S2.

[0018] 所述脉冲发生模块具有扫频功能;当设定基准频率为讯1和讯2,扫频范围为F3, 扫频精度为S3, W及扫描时间为T3,所述脉冲发生模块将分别W讯1和讯2、讯1+S3和讯2、讯1+2S3和讯2…讯l+nS3和讯2、讯1-S3和讯2、讯1-2S3和讯2…讯l-nS3和讯2、讯1和讯化S3、讯1和讯化2S3…讯1和讯2+nS3、讯1和讯2-S3、讯1和讯2-2S3 …讯1和讯2-nS3交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T3,其中,n为自然数,且n =F3/S3。 [0018] The pulse generating module having a sweep function; if the reference frequency is set to 1 and the information inquiry 2, F3 sweep range, accuracy is swept S3, W and the scanning time T3, the pulse generation block, respectively W information 1 and information 2, information 1 + S3 and information 2, information 1 + 2S3 and information 2 ... News l + nS3 and information 2, information 1-S3 and information 2, information 1-2S3 and information 2 ... news l-nS3 and information 2, information 1 and hearing of S3, information 1 and information of 2S3 ... information 1 and information 2 + nS3, information 1 and information 2S3, information 1 and information 2-2S3 ... information 1 and information 2-nS3 alternately outputs two electrical stimulation pulse trains, and each of the two duration of the electrical stimulation pulse train output alternately as T3, where, n-is a natural number, and n = F3 / S3.

[0019] 所述脉冲发生模块具有扫频功能;当设定基准频率为讯1和讯2,扫频范围为F3,扫频精度为S3, W及扫描时间为T3,所述脉冲发生模块将分别W讯1和讯2、讯1+S3 和讯化S3、讯1+2S3和即化2S3…讯l+nS3和讯2+nS3、讯1-S3和讯2-S3、讯1-2S3和讯2-2S3…讯l-nS3和讯2-nS3、讯1+S3和讯2-S3、讯1+2S3和讯2-2S3…讯l+nS3和讯2-nS3、讯1-S3和讯化S3、讯1-2S3和讯化2S3…讯l-nS3和讯2+nS3交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T3,其中,n为自然数,且n =F3/ S3。 [0019] The pulse generating module having a sweep function; if the reference frequency is set to 1 and the information inquiry 2, F3 sweep range, accuracy is swept S3, W and the scanning time T3, the pulse generation block, respectively W 1 and news information 2, information of 1 + S3 and S3 information, i.e., information 1 + 2S3 and 2S3 of information ... and l + nS3 2 + NS3 information, news information and 1-S3 2S3, news and information 2-2S3 ... 1-2S3 News l-nS3 and telecommunications 2-nS3, News 1 + S3 and information 2S3, News 1 + 2S3 and information 2-2S3 ... News l + nS3 and telecommunications 2-nS3, News 1-S3 and the information of S3, information 1-2S3 and hearing of ... 2S3 l-nS3 news and information 2 + nS3 alternately outputs two electrical stimulation pulse trains, and the duration of each stimulation pulse train alternately outputs two electrical is T3, where, n-is a natural number, and n = F3 / S3.

[0020] 所述扫频范围F3为1赫兹〜20赫兹,所述扫频精度S3为1赫兹~10赫兹,所述扫描的时间T3为5砂〜60分钟可调。 [0020] The sweep range is 1 Hz F3 ~ 20 Hz, said sweeping accuracy S3 1 Hz to 10 Hz, the scan time T3 is 5 ~ 60 minutes adjustable sand.

[0021] 所述扫频范围F3为5赫兹~10赫兹,所述扫频精度S3为2赫兹〜5赫兹,所述扫描的时间T3为30砂~10分钟可调。 [0021] F3 is the sweep range 5 Hz to 10 Hz, said sweeping accuracy S3 ~ 5 Hz to 2 Hz, the scan time T3 of sand is 30 to 10 minutes adjustable.

[0022] 一种电脉冲刺激测试装置,其包括;一体外测试刺激器W及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其中,所述脉冲发生模块至少可W产生变频刺激脉冲信号。 [0022] An electrical pulse stimulation test apparatus, comprising; an outer one, and W is a test stimulus test leads, and the in vitro test stimulator comprises a pulse generating modules, wherein at least said pulse generating module may generate frequency stimulation W Pulse signal.

[0023] -种电脉冲刺激测试装置,其包括;一体外测试刺激器W及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其中,所述脉冲发生模块至少可W产生变频刺激脉冲信号,该变频刺激脉冲信号仅包括两种或H种不同频率的电刺激脉冲串交替刺激形成多个脉冲串周期。 [0023] - Test Species electrical stimulation device comprising; an outer one, and W is a test stimulus test leads, and the in vitro test stimulator comprises a pulse generating modules, wherein at least said pulse generating module may generate frequency stimulation W pulse signal, the pulse frequency stimulation signal comprises only two kinds of H or electrical stimulation pulse trains of different frequencies are alternately formed a plurality of stimulation burst periods.

[0024] -种采用上述电脉冲刺激测试装置的电脉冲刺激测试系统。 [0024] - With the above kinds of electric pulse electrical stimulation pulse stimulation test apparatus testing system.

[0025] 与现有技术相比较,本发明的电脉冲刺激测试装置或测试系统通过引入变频刺激脉冲信号,可W用于测试患者是否适合采用变频刺激脉冲信号进行治疗。 [0025] Compared with the prior art, an electrical stimulation pulse testing apparatus of the present invention or by introducing a test system stimulation pulse signal frequency, W may be used to test whether a patient stimulation pulse signal suitable for conversion treatment.

附图说明 BRIEF DESCRIPTION

[0026] 图1为本发明实施例提供的植入式电脉冲刺激系统的结构示意图。 [0026] Fig 1 a schematic view of an implantable electrical stimulation system according to an embodiment of the present invention.

[0027] 图2为图1的植入式电脉冲刺激系统的脉冲发生器的模块示意图。 Module [0027] FIG. 2 is an implantable electrical stimulation system 1 is a schematic diagram of the pulse generator.

[0028] 图3为本发明实施例提供的植入式电脉冲刺激系统的变频刺激脉冲信号与现有技术的恒频刺激脉冲信号的对比图。 [0028] FIG. 3 FIG comparison frequency stimulation pulse signal implantable electrical stimulation system provided in the prior art constant frequency stimulation pulse signal according to the present invention.

[0029] 图4为本发明实施例提供的植入式电脉冲刺激系统产生的第一种变频刺激脉冲信号示意图。 [0029] FIG 4 a first schematic diagram frequency stimulation pulse implantable electrical stimulation pulse generated by the system provided by the embodiment of the present invention.

[0030] 图5为本发明实施例提供的植入式电脉冲刺激系统产生的第二种变频刺激脉冲信号示意图。 [0030] Fig 5 a schematic view of a second pulse signal frequency stimulation pulse implantable electrical stimulation system according to embodiments of the present invention produced.

[0031] 图6为本发明实施例提供的植入式电脉冲刺激系统产生的第H种变频刺激脉冲信号示意图。 [0031] Fig 6 a schematic view of signal frequency stimulation pulse H kind implantable electrical stimulation system according to the embodiment of the present invention produced.

[0032] 图7为本发明实施例提供的植入式电脉冲刺激系统产生的第四种变频刺激脉冲信号示意图。 [0032] Figure 7 a schematic view of a fourth pulse signal frequency stimulation pulse implantable electrical stimulation system according to embodiments of the present invention produced.

[0033] 图8为本发明实施例提供的植入式电脉冲刺激系统产生的第五种变频刺激脉冲信号示意图。 [0033] Figure 8 a schematic view of signal frequency stimulation pulse fifth implantable electrical stimulation system according to embodiments of the present invention produced.

[0034] 图9为本发明实施例提供的植入式电脉冲刺激系统的脉冲发生器的第一种扫频模式的电刺激脉冲信号的频率-时间关系图。 Time diagram - [0034] FIG. 9 frequency electrical stimulation pulse signal of a first pulse generator sweep mode implantable electrical stimulation system according to an embodiment of the present invention.

[0035] 图10为本发明实施例提供的植入式电脉冲刺激系统的脉冲发生器的第二种扫频模式的电刺激脉冲信号的频率-时间关系图。 Frequency sweep mode of the second electrical [0035] The implantable pulse generator 10 of FIG electrical stimulation system according to an embodiment of the present invention, the stimulation pulse signals - time diagram.

[0036] 图11为本发明实施例提供的植入式电脉冲刺激系统的脉冲发生器的第H种扫频模式的电刺激脉冲信号的频率-时间关系图。 Time diagram - [0036] 11 frequency electrical stimulation pulse signal H kind of sweep mode pulse generator implantable electrical stimulation system according to an embodiment of the present invention.

[0037] 图12为本发明实施例提供的植入式电脉冲刺激系统的脉冲发生器的第四种扫频模式的电刺激脉冲信号的频率-时间关系图。 Time diagram - [0037] 12 electrical stimulation pulse signal frequency sweep mode of the fourth pulse generator implantable electrical stimulation system according to an embodiment of the present invention.

[0038] 图13为本发明实施例提供的电脉冲刺激测试系统的结构示意图。 [0038] FIG 13 a schematic view of the structure of the electrical stimulation pulses provided by the test system according to the present invention.

[0039] 图14为图13的电脉冲刺激测试系统的脉冲发生模块的模块示意图。 Module schematic block [0039] FIG. 14 is an electrical stimulation pulse test system 13 of FIG pulse generation.

[0040] 主要元件符号说明 [0040] Main reference numerals DESCRIPTION

Figure CN104548349AD00061

Figure CN104548349AD00062

Figure CN104548349AD00071

如下具体实施方式将结合上述附图进一步说明本发明。 The following detailed description in conjunction with the accompanying drawings, the present invention is described.

具体实施方式 Detailed ways

[0041] 下面将结合附图及具体实施例,对本发明提供的植入式电脉冲刺激系统,电脉冲刺激测试系统,W及采用该植入式电脉冲刺激系统刺激神经组织的方法。 [0041] The accompanying drawings and the following embodiment, an implantable electrical stimulation system of the present invention provides, electrical stimulation test system, W, and the method implantable electrical stimulation system to stimulate the nerve tissue.

[0042] 可W理解,本发明提供的植入式电脉冲刺激系统可W为也脏起搏器、除颤器、脑深部电刺激器、脊髓刺激器、迷走神经刺激器、肠胃刺激器、肌肉刺激器、外周神经刺激器或者其他类似的刺激器。 [0042] W may be appreciated, an implantable electrical stimulation system of the present invention may be W is also provided pacemaker, defibrillator, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, stimulator stomach, muscle stimulation, peripheral nerve stimulation, or other similar stimulator. 本发明实施例仅W植入式脑深部电刺激器为例进行说明。 As an example embodiment of the present invention W only an implantable deep brain stimulator.

[0043] 请参见图1-2,本发明实施例提供一植入式脑深部电刺激器10,其包括:一植入皮下的脉冲发生器11,一植入深脑部位的刺激电极12, 一连接该刺激电极12和脉冲发生器11 的延长导线13, W及一用于程控该脉冲发生器11的体外程控仪14。 [0043] Referring to FIG 1-2, an embodiment of an implantable deep brain stimulator 10 of the present invention, comprising: a pulse generator implanted under the skin 11, a portion of the implant deep brain stimulation electrodes 12 a lead connected to the stimulation electrode 12 and the extension 11 of the pulse generator 13, W and in vitro for a programmer to the pulse generator 11 is programmed 14.

[0044] 所述脉冲发生器11产生特定的电刺激脉冲信号15,并通过所述延长导线13和刺激电极12导通至刺激部位进行刺激调控。 [0044] The pulse generator 11 generates a particular electrical stimulation pulse signal 15, and the extension wire Stimulation by stimulating electrodes 13 and 12 is conducted to the site of stimulation. 所述体外程控仪14可W与所述脉冲发生器11 无线连接,并改变其电脉冲刺激参数。 The extracorporeal programmer 14 W with the pulse generator may be a wireless connection 11, and changes its electrical stimulation parameters.

[0045] 所述刺激电极12尖端具有多个触点,且将刺激电极12植入祀点位置后,至少有一个触点与刺激祀点接触紧密,W将适当的电刺激传导至祀点,治疗神经类的疾病。 After [0045] the stimulation tip electrode having a plurality of contacts 12, 12 and the stimulation electrode implanted Si position, at least one contact point in close contact with the stimulus Si, W will be transmitted to the appropriate electrical stimulation points Si, treatment of diseases of the nervous type. 可W理解,所述刺激电极12根据刺激需要可W为一个或者多个,对相应的位置进行刺激,W保证刺激效果。 W can be appreciated, the stimulation electrode 12 as one or more, the corresponding position may be required to stimulate the stimulatory W, W ensure stimulatory effect. 可W理解,所述刺激电极12的个数不限于一个,可W根据需要选择。 W can be appreciated that the number of stimulation electrodes 12 is not limited to one, may be selected according to W.

[0046] 可W理解,所述延长导线13为一可选元件,所述刺激电极12可W直接连接到该脉冲发生器11上。 [0046] W can be appreciated, the elongated wire element 13 as an alternative, the stimulation electrodes 12 may be connected directly to the W of the pulse generator 11. 只有当所述刺激电极12与该脉冲发生器11植入体内后的距离较大时,才需要通过延长导线13连接。 Only when the stimulation electrode 12 and the distance from the body after implantation of the pulse generator 11 is large, it needs to be connected by wires 13 extend.

[0047] 所述脉冲发生器11内部包括:一微处理器模块111、一电源模块112及一无线通讯模块113。 The interior 11 [0047] The pulse generator comprising: a microprocessor module 111, a power module 112, and a wireless communication module 113. 所述微处理器模块111、电源模块112及无线通讯模块113之间电性连接。 The microprocessor module 111, power module 112 and wireless communication module 113 is electrically connected between the. 所述微处理器模块111有编辑好的程序,能够产生不同频率、不同脉宽、不同幅值的电刺激脉冲信号15。 The microprocessor 111 has edited program modules, capable of generating different frequencies, different pulse widths, different amplitudes of the electrical stimulation pulse signal 15. 另外,所述无线通讯模块113与所述体外程控仪14无线连接,从而通过所述体外程控仪14可W选择所述微处理器模块111的程序,调节程序参数,从而改变输出的电刺激脉冲信号15。 Further, the wireless communication module 113 to the wireless connection 14 in vitro programmer to program the microprocessor module 111 through the extracorporeal programmer 14 W can be selected, the parameter adjustment procedure, thereby changing the output of electrical stimulation pulses signal 15.

[0048] 请参见图3,所述脉冲发生器11产生的电刺激脉冲信号15的刺激波形可W是普通的恒频刺激脉冲信号,也可W为变频刺激脉冲信号。 [0048] Referring to FIG 3, the electrical stimulation pulse signal of the pulse generator 11 generates stimulation waveform W 15 may be an ordinary stimulation pulse constant frequency signal, frequency stimulation may be W is a pulse signal. 然而,所述脉冲发生器11至少可W产生变频刺激脉冲信号。 However, the pulse generator can be at least 11 W generates a pulse signal frequency stimulation.

[0049] 请参见图4-6,所述变频刺激脉冲信号150包括至少两种不同频率的电刺激脉冲 [0049] Referring to FIG 4-6, the stimulation pulse frequency signal 150 includes at least two different frequencies of electrical stimulation pulses

Figure CN104548349AD00072

串152交替刺激形成多个脉冲串周期151,且每个频率的电刺激脉冲串152在每个脉冲串周期151中持续的时间为0. 1砂~30分钟。 A plurality of strings 152 are alternately formed stimulation burst periods 151 and 152 each electrical stimulation burst frequency continuously in each burst cycle time of 151 sand 0.1 to 30 minutes. 可W理解,如果每个频率的电刺激脉冲串152持续的时间太短,例如,小于0. 1砂,则刺激时间和单个脉冲的脉宽大小同处一个数量级,不同频率的脉冲紧密相连,效果有很大的不可控制性。 W can be appreciated, if the frequency of the electrical stimulation pulse for each string 152 short duration, e.g., less than 0.1 sand, at the same time the size of the stimulation pulse and a magnitude of a single pulse, pulses of different frequencies of closely linked, the effect is very uncontrollable. 而如果每个频率的电刺激脉冲串152 持续的时间太长,例如,大于30分钟,患者会对单一频率产生适应,长时间刺激容易使患者对刺激产生适应性,类似对药物产生的抗药性,效果类似于恒频刺激。 If each frequency electrical stimulation burst duration 152 is too long, e.g., greater than 30 minutes, the patient will have to adapt a single frequency is generated, a long time tends to stimulate the patient to produce the adaptive stimulation produced a similar drug resistant , the effect is similar to the constant-frequency stimulation.

[0050] 优选地,每个频率的电刺激脉冲串152在每个脉冲串周期151中持续的时间为3 砂〜60砂。 [0050] Preferably, each of the 152 frequency electrical stimulation burst continues in each burst cycle time is 151 ~ 60 3 Sand Sand. 更优选地,每个频率的电刺激脉冲串152在每个脉冲串周期151中持续的时间为5砂〜30砂。 More preferably, the electrical stimulation burst duration 152 of each frequency burst in each time period 151 is 5 ~ 30 sand sand. 在该个时间段内,既能保证所包含的频率对祀点细胞能够产生充分的效果, 又能防止患者对某种频率的刺激产生适应性。 In this period of time it is, both to ensure a frequency included in the Si-point cell capable of producing a sufficient effect, but also to prevent the patient to a stimulus to adaptive frequency.

[0051] 所述电刺激脉冲串152的频率小于等于380赫兹。 [0051] 152 of the electrical stimulation burst frequency 380 Hz or less. 优选地,所述电刺激脉冲串152 的频率为30赫兹〜250赫兹。 Preferably, the electrical stimulation frequency burst 152 is 30 Hz ~ 250 Hz. 更优选地,所述电刺激脉冲串152的频率为50赫兹〜150赫兹。 More preferably, the electrical stimulation frequency burst 152 is 50 Hz ~ 150 Hz. 当刺激频率低于30赫兹时,对患者的运动症状改善情况不明显,在更低频率时甚至使其运动症状恶化。 When the stimulation frequency below 30 Hz, the movement of the patient's symptoms improved without appreciably, even at lower frequency moving aggravate symptoms. 临床所用的恒频刺激频率在100赫兹左右效果比较好,所W优选50赫兹〜150赫兹的刺激范围,在保证对主要病症效果或者改善主要症状的前提下,同时对不良附带症状改善。 Clinically used constant frequency of about 100 Hz stimulation frequency results were better, W is preferably 50 Hz ~ 150 Hz range of stimuli, while ensuring the effect of the main disease or ameliorate the symptoms of primary, while incidental adverse symptoms.

[0052] 所述不同频率的电刺激脉冲串152的平均值为60赫兹〜180赫兹,优选为,80赫兹〜120赫兹。 [0052] The average value of the electrical stimulation pulse trains at different frequencies of 152 Hz to 60 ~180 Hz, preferably 80 Hz ~ 120 Hz. 所述不同频率的电刺激脉冲串152的几何平均值为60赫兹〜180赫兹,优选为, 80赫兹〜120赫兹。 The geometric mean of the electrical stimulation pulse trains of different frequencies of 152 Hz to 60 ~180 Hz, preferably 80 Hz ~ 120 Hz. 在临床数据来看,100赫兹〜130赫兹之间的局频刺激有利于帕金森患者主要症状的改善,60〜80赫兹的刺激,有利于构音障碍及起步困难等不良症状的改善。 In the clinical data, the bureau between ~130 Hz frequency 100 Hz stimulation will help to improve the main symptoms of Parkinson's patients, 60~80 Hz stimulation will help to improve dysarthria and difficulty starting and other adverse symptoms. 将两种或者多种频率的刺激脉冲结合成为变频刺激,平均刺激频率约为80〜120赫兹。 The stimulus pulse frequency is two or more frequency stimulation combined into an average of about 80~120 Hz stimulation frequency.

[0053] 所述不同频率的电刺激脉冲串152的个数为N,且2《N<10。 [0053] The number of different frequencies of electrical stimulation pulse train is 152 N, and 2 "N <10. 优选地,2《N《5。 Preferably, 2 "N" 5. 更优选地,所述不同频率的电刺激脉冲串152的个数为2或3。 More preferably, the different frequencies of electrical stimulation pulse train 152 is the number 2 or 3. 可W理解,过多的频率数目在实施过程中使得调节过程更加复杂,可W通过先使用少量不同频率的脉冲刺激对患者进行调控,确定患者对该种刺激方式是否适应,并确定是否向着更优的方向改善。 W can be appreciated, excessive number of frequency adjustment process in the embodiment such that the process is more complicated, W may be a small amount by using the first stimulation pulse of a different frequency to regulate the patient, whether the patient is determined to adapt the stimuli embodiment, and determine whether more toward improve the preferred direction. 再根据患者的反应,适当增加不同频率的数量,优化刺激效果。 The response of the patient and then, appropriately increase the number of different frequencies, to optimize stimulatory effect.

[0054] 所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的时间比大于5%。 The [0054] 152 electrical stimulation pulse trains at different frequencies of each burst time period 151 is greater than 5%. 优选地,所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的时间比大于20%。 Preferably, the electrical stimulation pulse trains at different frequencies of 152 times during each burst period 151 is greater than 20%. 更优选地,所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的时间比大于30%。 More preferably, the electrical stimulation pulse trains at different frequencies of 152 times during each burst period 151 is greater than 30%. 因为不同频率的脉冲特征可能对应不同的症状,控制其占比在5% W上,W确保对该症状的调控效果。 Because the pulse characteristics corresponding to different frequencies may be different symptoms, which controls the proportion of 5% W, W ensure the control effect of the symptoms. 当所述不同频率的电刺激脉冲串152的个数为2时或3,优选地,所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的时间比为1/N,其中,N为所述不同频率的电刺激脉冲串152的个数。 When the number of electrical stimulation pulse train 152 of the different frequencies is 2 or 3, preferably, the different frequencies of electrical stimulation pulse train 152 times during each burst cycle 151 ratio is 1 / N, where , the number N of burst 152 to the electrical stimulation of different frequencies. 例如,当所述不同频率的电刺激脉冲串152的个数为2时,所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的时间比为50%。 For example, when the number of the electrical stimulation pulse trains of different frequencies is 2 152, the different frequencies of electrical stimulation pulse train 152 times during each burst period 151 ratio of 50%.

[0055] 所述不同频率的电刺激脉冲串152在每个脉冲串周期151中的出现顺序可W为从低频到高频,从高频到低频,也可某种随机的方式出现,只要确保在同一个脉冲串周期151中,每个电刺激脉冲串152所占的时间比例一定即可。 [0055] The order of appearance of pulse trains 152 electrical stimulation of different frequencies each burst period may be 151 W from low to high, from high to low frequency, may also occur in some random manner, to ensure long in the same burst period 151, a certain proportion to the time occupied by the burst 152 of each electrical stimulation.

[0056] 所述不同频率的电刺激脉冲串152可W为电流模式或电压模式。 The [0056] 152 electrical stimulation pulse trains of different frequencies W may be a current mode or a voltage mode. 若采用电流模式,电流大小为0毫安~30毫安可调,调节精度为0. 1毫安。 If the current mode is the current size of ~ 30 mA 0 mA adjustable, adjustment accuracy is 0.1 mA. 若采用电压模式,电压大小为0伏特~15伏特可调节,调节精度为0. 1伏特。 When using a voltage mode, the voltage 0 V to a size of 15 volts can be adjusted, the adjustment accuracy of 0.1 volt.

[0057] 具体地,请参见图3,本发明提供的第一种变频刺激脉冲信号150包括两种不同频率的电刺激脉冲串152交替刺激形成多个脉冲串周期151,且每种频率的电刺激脉冲串152 时间占比相同。 [0057] In particular, see Figure 3, a first frequency stimulation pulse signal 150 provided by the present invention comprises two electrical stimulation pulse trains 152 are alternately formed a plurality of different frequencies stimulation burst period 151, and the frequency of each electrical 152 burst stimulation same time accounting. 请参见图4,本发明提供的第二种变频刺激脉冲信号150包括两种不同频率的电刺激脉冲串152交替刺激形成多个脉冲串周期151,且每种频率的电刺激脉冲串152 时间占比不同。 Referring to Figure 4, a second frequency stimulation pulse signal 150 of the present invention to provide an electrical stimulation pulse train includes two different frequencies 152 are alternately formed a plurality of stimulation burst period 151, and the electrical stimulation of each frequency burst 152 Time Percentage than different. 请参见图5,本发明提供的第一种变频刺激脉冲信号150包括H种不同频率的电刺激脉冲串152交替刺激形成多个脉冲串周期151,且每种频率的电刺激脉冲串152 时间占比不同。 Referring to FIG 5, a first frequency stimulation pulse signal 150 provided by the present invention includes an electrical stimulation pulse trains H 152 kinds of different frequencies are alternately formed a plurality of stimulation burst period 151, and the frequency of each electrical stimulation burst 152 Time Percentage than different.

[005引请参见图7-8,可W理解,不同频率的电刺激脉冲串152可W连续出现,也可W间断出现。 [005 Referring to FIG primers 7-8, W can be appreciated, the electrical stimulation pulse trains of different frequencies may be 152 consecutive W, W may occur intermittently. 即,相邻两个不同频率的电刺激脉冲串152之间可則哥隔一定时间。 That is, two different frequencies of electrical stimulation of the adjacent Columbia predetermined time interval 152 between bursts. 所述多个脉冲串周期151可W连续出现,也可W间断出现。 Said plurality of burst periods 151 may be consecutive W, W may occur intermittently. 目P,相邻两个脉冲串周期151之间也可W间隔一定时间。 Head P, between adjacent two burst period W 151 may be a certain time interval. 所述相邻两个不同频率的电刺激脉冲串152之间的时间间隔154 W及相邻两个脉冲串周期151之间的时间间隔154可W为0. 01砂〜60砂。 The adjacent two different frequency electrical stimulation time 152 between burst time interval of 154 W and 151 between two adjacent spacer burst period 154 may be W is 0.01 ~ 60 sand sand. 优选地,间隔时间为T/N, 其中,T为一个脉冲串周期151的循环时间,N为不同频率的电刺激脉冲串152的个数。 Preferably, the time interval of T / N, where, T is the cycle time of a burst period 151, N is the number of different frequencies of electrical stimulation pulse train 152. 该样技能保证间隔时间的有效性,又能保证间隔时间不至于太大,防止过大的时间间隔导致刺激无效。 The kind of skills to ensure the validity interval of time, but also ensures that the time interval is too large and will not, prevent excessive intervals invalidate stimulation.

[0059] 进一步,所述脉冲发生器11内还可W存储多种经验刺激频率的电刺激脉冲串152 组合,适用于常规情况。 [0059] Further, the electric pulse generator 11 may also store a variety of experience W stimulation frequency burst stimulation 152 compositions for the conventional case. 该经验刺激频率的电刺激脉冲串152组合可W为50赫兹与150赫兹、60赫兹与140赫兹、70赫兹与130赫兹、80赫兹与120赫兹、90赫兹与110赫兹,且每种频率的电刺激脉冲串152的时间占比均为50%。 The experience of the stimulation frequency stimulation burst 152 may be electrically compositions W and 150 Hz to 50 Hz, 60 Hz and 140 Hz, 70 Hz and 130 Hz, 80 Hz and 120 Hz, 90 Hz and 110 Hz, and the frequency of each electrical time accounting stimulation burst 152 was 50%. 该经验刺激频率的电刺激脉冲串152组合的不同频率的平均值相同。 The average stimulation frequency experience the same electrical stimulation burst 152 different combinations of frequencies. 可W理解,所述脉冲发生器11内还可W存储多种经验的刺激电流值,例如;〇. 5毫安、1毫安、1. 5毫安、2毫安、2. 5毫安。 W can be appreciated, W may also store a variety of stimuli experienced a current value of the pulse generator 11, for example; square 5 mA, 1 mA, 15 mA, 2 mA, 25 mA... . 该刺激电流值可W与上述电刺激脉冲串152组合配合使用。 The stimulus current value W may be a combination of the electrical stimulation pulse train with 152 used in conjunction.

[0060] 使用时,可W根据需要选择不同的电刺激脉冲串152组合和刺激电流值。 [0060] In use, W can select a different combination of strings 152 and a current value of the stimulation pulses in accordance with electrical stimulation. 例如,在正常工作状态下,采用80赫兹与120赫兹的交替刺激,每种时间占比为50%,刺激电流大小为2毫安。 For example, in normal operation, using the 80 Hz and 120 Hz alternating stimulus, each accounting for 50% of the time, the size of the stimulus current is 2 mA. 或者,对于病情较轻的患者,采用80赫兹与120赫兹的交替刺激,每种时间占比为50%,刺激电流大小为1. 5毫安。 Alternatively, for patients with less severe using 80 Hz and 120 Hz alternating stimulus, each accounting for 50% of the time, the size of the stimulus current 1.5 mA.

[0061] 进一步,所述脉冲发生器11具有扫频功能。 [0061] Further, the pulse generator 11 with a frequency sweep function. 通过体外程控仪14设定该脉冲发生器11的扫频参数后,该脉冲发生器11可W按照该参数进行扫频。 After in vitro by programmer 14 to set the parameters of the sweep of the pulse generator 11, the pulse generator 11 may be swept in accordance with the parameter W. W下介绍所述脉冲发生器11的不同的扫频模式。 Describes the pulse generator 11 is different from the next sweep mode W.

[0062] 第一种扫频模式为单一频率扫频。 [0062] The first sweep mode a single frequency sweep. 该单一频率扫频模式中,当设定扫频范围为Flmin〜Flmax,扫频精度为S1,扫描时间为T1,所述脉冲发生器11将W Flmin、Flmin+Sl、 Flmin+2Sl、Flmin+3Sl…Flmin+nSl、W及Flmax分别输出一电刺激脉冲串152,且每个电刺激脉冲串152的持续时间为T1,其中,n为自然数,且n《(Flmax-Flmin)/Sl。 The single frequency sweep mode, the sweep range is set to Flmin~Flmax, sweep accuracy as S1, the scan time is T1, the pulse generator 11 W Flmin, Flmin + Sl, Flmin + 2Sl, Flmin + 3Sl ... Flmin + nSl, W, and outputs an electrical stimulation Flmax burst 152 and the duration of each stimulation pulse train 152 is T1, where, n-is a natural number, and n "(Flmax-Flmin) / Sl. 所述扫频范围Flmin〜Flmax可W在0赫兹〜380赫兹之间选择。 Flmin~Flmax the sweep range may be selected between 0 W ~380 Hz Hertz. 所述扫频精度S1可W为1赫兹〜10 赫兹可调,优选地采用2赫兹〜5赫兹可调。 The sweep S1 accuracy may be W ~ 10 Hz to 1 Hz is adjustable, preferably adjustable using 2 Hz ~ 5 Hz. 所述扫描时间T1可W为5砂〜60分钟可调,优选地采用10砂~30分钟可调。 The scanning time T1 may be W is 5 ~ 60 minutes adjustable sand, the sand is preferably 10 to 30 minutes using adjustable. 例如,设定扫频范围为50赫兹〜150赫兹,扫频精度10赫兹,单一频率扫描时间10砂。 For example, sweep range is set to 50 Hz ~ 150 Hz, 10 Hz accuracy sweep, the frequency sweep time of 10 single sand. 所述脉冲发生器11将分别W 50赫兹、60赫兹、70赫兹、80赫兹、90赫兹、100赫兹、110赫兹、120赫兹、130赫兹、140赫兹W及150赫兹分别输出一电刺激脉冲串152,且每个电刺激脉冲串152持续10砂。 The pulse generator 11 respectively W 50 Hz, 60 Hz, 70 Hz, 80 Hz, 90 Hz, 100 Hz, 110 Hz, 120 Hz, 130 Hz, 140 Hz and 150 Hz, respectively, W outputs a burst of electrical stimulation 152 and each electrical stimulation burst duration 152 10 sand. 请参见图9,为本发明实施例提供的脉冲发生器的第一种扫频模式的电刺激脉冲信号的频率-时间关系图,其中,n=4。 Referring to FIG 9, the present invention is the frequency of the electrical stimulation pulse signal a first sweep mode according to an embodiment of the pulse generator - time diagram, where, n = 4.

[0063] 第二种扫频模式为多频率交替递进扫频。 [0063] The second multi-frequency sweep mode to alternately progressive sweep. 该多频率交替递进扫频模式中,当设定扫频范围为巧min〜F2max,扫频精度为S2,扫描时间为T2,所述脉冲发生器11将W巧min和^max、^min+SS 和^max-SS、F2min巧S2 和巧1113义-252 …W及^min+nSS 和^max-nSS 分别交替输出两个电刺激脉冲串152,且每两个电刺激脉冲串152交替输出的持续时间为T2,其中,n为自然数,且n<(F2max-巧min)/2S2。 The multi-frequency alternating progressive sweep mode, the sweep range is set to clever min~F2max, accuracy is swept S2, the scan time is T2, the pulse generator 11 min and clever W ^ max, ^ min + SS and ^ max-SS, F2min S2 clever sense and clever 1113 -252 ... W and ^ min + nSS ^ max-nSS and alternately outputs two pulse trains 152 electrical stimulation, electrical stimulation and every two alternating bursts 152 duration of the output of T2, where, n-is a natural number and n <(F2max- clever min) / 2S2. 可W理解,所述扫描时间T2应为每个脉冲串周期151的持续时间的整数倍。 W can be appreciated, the scanning time T2 should be an integer multiple of the duration 151 of each burst period. 所述扫频范围巧min〜F2max可W在0赫兹〜380赫兹之间选择。 The sweep range W may be selected min~F2max coincidence between 0 Hz ~380 Hz. 所述扫频精度S2可W为1赫兹~1〇赫兹可调,优选地采用2赫兹〜5赫兹可调。 The sweep S2 accuracy may be W ~ 1 Hz 1〇 Hz adjustable, preferably adjustable using 2 Hz ~ 5 Hz. 所述扫描时间T2可W为5砂〜60分钟可调,优选地采用30砂~10分钟可调。 The scan time T2 may be W is 5 ~ 60 minutes adjustable sand, preferably with 30 to 10 minutes adjustable sand. 例如,设定扫频范围为50赫兹〜150赫兹,扫频精度10赫兹,扫描时间T2为30砂,所述脉冲串周期151 的持续时间为2砂,且每个电刺激脉冲串152持续时间为1砂。 For example, sweep range is set to 50 Hz ~ 150 Hz, 10 Hz sweep precision, scanning time T2 of the sand 30, the duration of the burst period 151 is 2 sand, and each electrical stimulation burst duration 152 1 sand. 所述脉冲发生器11将W 50 赫兹与150赫兹、60赫兹与140赫兹、70赫兹与130赫兹、80赫兹与120赫兹、W及90赫兹与110赫兹分别交替输出两个电刺激脉冲串152从而形成15个脉冲串周期151。 The pulse generator 11 W 50 Hz and 150 Hz, 60 Hz and 140 Hz, 70 Hz and 130 Hz, 80 Hz and 120 Hz, W, and 90 Hz and 110 Hz are alternately outputs two pulse trains 152 electrical stimulation so 15 is formed burst periods 151. 请参见图10,为本发明实施例提供的脉冲发生器的第二种扫频模式的电刺激脉冲信号的频率-时间关系图,其中,n=2。 A second electrical frequency sweep mode, see Figure 10, the pulse generator of the present invention according to an embodiment of the stimulation pulse signals - time diagram, where, n = 2.

[0064] 第H种扫频模式为多频率交替组合扫频。 [0064] H kind of multi-frequency sweep mode to alternately sweep combination. 该多频率交替组合扫频模式中,当设定基准频率为讯1和讯2,扫频范围为F3,扫频精度为S3,扫描时间为T3,所述脉冲发生器11 将分别W讯1和讯2、讯1+S3和讯2、讯1+2S3和讯2…讯l+nS3和讯2、讯1-S3和讯2、 讯1-2S3和讯2…讯l-nS3和讯2、讯1和讯化S3、讯1和讯化2S3…讯1和讯2+nS3、 讯1和讯2-S3、讯1和讯2-2S3…讯1和讯2-nS3交替输出两个电刺激脉冲串152,且每两个电刺激脉冲串152交替输出的持续时间为T3,其中,n为自然数,且n =F3/S3。 The combination of multi-frequency alternating sweep mode, when the information is set to 1 and the reference frequency information 2, F3 sweep range, accuracy is swept S3, the scan time T3, the pulse generator 11, respectively, and W 1 News News 2, information 1 + S3 and information 2, information 1 + 2S3 and information 2 ... News l + nS3 and information 2, information 1-S3 and information 2, information 1-2S3 and information 2 ... news l-nS3 and information 2, information 1 and information of S3, 1 information and information of a news and information ... 2S3 2 + nS3, news and information 2S3 1, an information inquiry and information 2-2S3 ... 1 2-nS3 information and alternately outputs two pulse trains 152 electrical stimulation, electrical stimulation pulses and each two duration string 152 is output alternately T3, where, n-is a natural number, and n = F3 / S3. 可W理解,所述扫描时间T3应为每个脉冲串周期151的持续时间的整数倍,且扫频范围为F3为扫频精度S3的整数倍。 W can be appreciated, the scanning time T3 should be an integer multiple of the duration of each burst period 151, and the sweep range is an integer multiple of the sweep F3 accuracy S3. 所述基准频率为Fbl和Fb2可W根据实际需要选择,通常所述基准频率为讯1和讯2在60赫兹〜120赫兹之间。 Fbl and Fb2 W can be selected according to the reference frequency, the reference frequency is usually 1 information and information between the two 60 Hz ~ 120 Hz. 所述扫频范围F3可W在1赫兹~20赫兹之间选择,优选地F3在5赫兹~10赫兹之间选择。 The W F3 to sweep range between 1 Hz to 20 Hz selection, F3 is preferably selected between 5 Hz and 10 Hz. 所述扫频精度S3可W为1赫兹~1〇赫兹可调,优选地采用2赫兹〜5赫兹可调。 The accuracy of the swept S3 may be W ~ 1 Hz 1〇 Hz adjustable, preferably adjustable using 2 Hz ~ 5 Hz. 所述扫描时间T3可W为5砂〜60分钟可调,优选地采用30砂~10分钟可调。 The scanning time T3 may be W is 5 ~ 60 minutes adjustable sand, preferably with 30 to 10 minutes adjustable sand. 例如,设定基准频率为80赫兹和100赫兹、扫频范围为10赫兹,扫频精度5赫兹,每组频率组合交替扫描的时间1分钟,每个脉冲串周期151的持续时间为3 砂,且每个脉冲串周期151中的两个电刺激脉冲串152持续时间分别为1砂和2砂。 For example, the reference frequency is set to 80 Hz and 100 Hz, sweep range 10 Hz, 5 Hz sweep accuracy, the frequency combination of each alternate scanning time of 1 minute, the duration of each burst period 151 is a 3 sand, and two electrical stimulation of each burst period 151 burst duration 152 are 1 and 2 of sand sand. 所述脉冲发生器11将W 80赫兹和100赫兹、85赫兹和100赫兹、90赫兹和100赫兹、75赫兹和100赫兹、70赫兹和100赫兹、80赫兹和105赫兹、80赫兹和110赫兹、80赫兹和95赫兹、80赫兹和90赫兹分别交替输出两个电刺激脉冲串152从而形成20个脉冲串周期151。 The pulse generator 11 W 80 Hz and 100 Hz, 85 Hz and 100 Hz, 90 Hz and 100 Hz, 75 Hz and 100 Hz, 70 Hz and 100 Hz, 80 Hz and 105 Hz, 80 Hz and 110 Hz, 80 Hz and 95 Hz, 80 Hz and 90 Hz are alternately outputs two pulse trains 152 electrical stimulation to form a 20 burst periods 151. 请参见图11,为本发明实施例提供的脉冲发生器的第H种扫频模式的电刺激脉冲信号的频率-时间关系图,其中,F3=S3。 The first kind of electrical frequency sweep mode H is provided in the pulse generator embodiment, see Figure 11, of the present invention, the stimulation pulse signal - time diagram, wherein, F3 = S3.

[0065] 第四种扫频模式也为多频率交替组合扫频。 [0065] The fourth mode is also alternately sweep to sweep a multi-frequency combination. 该多频率交替组合扫频模式中,当设定基准频率为讯1和讯2,扫频范围为F3,扫频精度为S3,扫描时间为T3,所述脉冲发生器11将分别W讯1和讯2、讯1+S3和讯化S3、讯1+2S3和讯化2S3…讯l+nS3和讯2+nS3、 讯1-S3 和讯2-S3、印1-2S3 和印2-2S3 …印l-nS3 和印2-nS3、讯1+S3 和讯2-S3、印1+2S3 和讯2-2S3…讯l+nS3和讯2-nS3、讯1-S3和讯化S3、讯1-2S3和讯化2S3…讯l-nS3 和讯2+nS3交替输出两个电刺激脉冲串152,且每两个电刺激脉冲串152交替输出的持续时间为T3,其中,n为自然数,且n =F3/S3。 The combination of multi-frequency alternating sweep mode, when the information is set to 1 and the reference frequency information 2, F3 sweep range, accuracy is swept S3, the scan time T3, the pulse generator 11, respectively, and W 1 News News 2, information technology and telecommunications 1 + S3 S3, information inquiry 1 + 2S3 and 2S3 of information ... and l + nS3 2 + NS3 information, news information and 2S3 1-S3, and the printing plate 1-2S3 2-2S3 ... printing l-nS3 printing and 2-nS3, 1 + S3 hearing and hearing 2S3, and information printed 1 + 2S3 2-2S3 ... l + nS3 inquiry information and 2-nS3, news and information of 1-S3 S3, and information of inquiry 1-2S3 inquiry ... 2S3 l-nS3 2 + nS3 information and alternately outputs two pulse trains 152 electrical stimulation, and the duration of each of the two pulse trains 152 electrical stimulus is output alternately T3, where, n-is a natural number, and n = F3 / S3. 可W理解,所述第四种扫频模式与上述第H种扫频模式基本相同,其区别为:第H种扫频模式中,当讯1和讯2中的一个变化时,另一个保持不变;而第四种扫频模式中,当讯1和讯2中的一个变化时,另一个也可W变化。 W can be appreciated, the fourth and the first sweep mode H is substantially the same kind of sweep mode, the difference is: H first kind sweep mode, when a change in the information 1 and information 2, the other remains variable; the fourth sweep mode, when a change in the information 1 and information 2, W may also be a further change. 例如,设定基准频率为80赫兹和105赫兹、扫频范围为10赫兹,扫频精度5赫兹,每组频率组合交替扫描的时间1分钟,每个脉冲串周期151的持续时间为3砂,且每个脉冲串周期151中的两个电刺激脉冲串152持续时间分别为2砂和1砂。 For example, the reference frequency is set to 80 Hz and 105 Hz, sweep range 10 Hz, 5 Hz sweep accuracy, the frequency combination of each alternate scanning time of 1 minute, the duration of each burst period 151 is a 3 sand, and two electrical stimulation of each burst period 151 burst duration 152 sand and 1 2 respectively sand. 所述脉冲发生器11将W 80赫兹和105 赫兹、85赫兹和110赫兹、90赫兹和115赫兹、75赫兹和100赫兹、70赫兹和95赫兹、85赫兹和100赫兹、90赫兹和95赫兹、75赫兹和110赫兹、70赫兹和115赫兹分别交替输出两个电刺激脉冲串152从而形成20个脉冲串周期151。 The pulse generator 11 W 80 Hz and 105 Hz, 85 Hz and 110 Hz, 90 Hz and 115 Hz, 75 Hz and 100 Hz, 70 Hz and 95 Hz, 85 Hz and 100 Hz, 90 Hz and 95 Hz, 75 Hz and 110 Hz, 70 Hz and 115 Hz are alternately outputs two pulse trains 152 electrical stimulation to form a 20 burst periods 151. 请参见图12,为本发明实施例提供的脉冲发生器的第四种扫频模式的电刺激脉冲信号的频率-时间关系图,其中,F3=S3。 Fourth electrical frequency sweep mode, see Figure 12, the pulse generator of the present invention according to an embodiment of the stimulation pulse signals - time diagram, wherein, F3 = S3.

[0066] 请参见图13-14,本发明实施例进一步提供一电脉冲刺激测试系统20,其包括:一体外测试刺激器21,一测试电缆22,一测试导线23 W及一刺激电极12。 [0066] Referring to Figure 13-14, a further embodiment of the present invention to provide an electrical pulse stimulation test system 20, comprising: an outer one test stimulus 21, a cable 22 test, a test lead 23 W and a stimulating electrode 12. 其中,本发明定义该体外测试刺激器21,测试电缆22 W及测试导线23为电脉冲刺激测试装置。 Wherein the present invention is defined in vitro stimulation test 21, test cable 22 W and 23 leads to test electrical stimulation test apparatus.

[0067] 使用时,将刺激电极12植入体内,将所述测试导线23的一端通过该测试电缆22 与所述体外测试刺激器21电连接,另一端与一植入体内的刺激电极12电连接。 [0067] In use, the stimulation electrode 12 implanted in vivo, the test end of the wire 23 of the cable 22 is electrically connected to the in vitro test stimulus 21 passes the test, the other end 12 is electrically a stimulation electrode implanted connection. 所述体外测试刺激器21产生特定的电刺激脉冲信号15,并通过所述测试电缆22、测试导线23 W及刺激电极12导通至刺激部位进行刺激调控。 The in vitro test specific stimulator 21 generates electrical stimulation pulse signal 15, and through the test cable 22, test leads 23 W and stimulating electrode 12 is turned on to stimulate the stimulation site regulation. 如果患者适合电刺激治疗,则该植入体内的刺激电极12无需取出。 If the patient for electrical stimulation therapy, the stimulation electrode 12 implanted in the body without removing.

[006引可W理解,所述测试电缆22为一可选元件,所述测试导线23也可W直接连接到该体外测试刺激器21上。 [006 W primers can be appreciated, the cable 22 is an alternative test element, the test leads 23 may be connected directly to the W stimulated in vitro test on 21. 所述测试电缆22无需采用生物相容性材料制备。 The test cable 22 was prepared without the use of a biocompatible material.

[0069] 所述测试导线23的两端分别设有连接器,W便与所述测试电缆22或刺激电极12 实现电连接。 Both ends of [0069] the test leads are respectively provided with a connector 23, W 12 will be electrically connected to the cable 22 or a test stimulation electrode. 由于使用时所述测试导线23会部分插入生物体内,因此,所述测试导线23至少与刺激电极12连接的部分采用生物相容性材料制备。 Since the use of the test leads 23 are partially inserted into a living body, and therefore, the test lead 23 Preparation and use of a biocompatible material connected to the stimulation electrode portion 12 at least. 优选地,所述测试导线23全部采用生物相容性材料制备。 Preferably, the test leads in all 23 Preparation of biocompatible material.

[0070] 所述体外测试刺激器21包括一体外脉冲发生模块210。 [0070] In vitro testing of the stimulator 21 comprises an outer integral pulse generation block 210. 所述脉冲发生模块210包括一微处理器模块211、一电源模块212、W及一控制模块213。 The pulse generation module 210 includes a microprocessor module 211, a power module 212, W 213 and a control module. 所述微处理器模块211、电源模块212及控制模块213之间电性连接。 The microprocessor module 211, power module 212 and control module is electrically connected between the 213. 所述微处理器模块211有编辑好的程序,能够产生不同频率、不同脉宽、不同幅值的电刺激脉冲信号15。 The microprocessor 211 has edited program module, capable of generating different frequencies, different pulse widths, different amplitudes of the electrical stimulation pulse signal 15. 所述控制模块213包括显示器、 输入键盘等。 The control module 213 includes a display, an input keyboard or the like. 通过所述控制模块213可W选择所述微处理器模块211的程序,调节程序参数,从而改变输出的电刺激脉冲信号15。 By the control module 213 may select the microprocessor W program module 211, the parameter adjustment procedure, changing the electrical stimulation pulse signal 15 output. 由于该体外脉冲发生模块210无需植入体内,其无需采用生物相容性材料制备。 As the in vitro pulse generation module 210 implanted in the body without, using a biocompatible material that does not require preparation.

[0071] 请参见图3-8,所述脉冲发生模块210也至少可W产生上述脉冲发生器11产生的变频刺激脉冲信号。 [0071] Referring to FIG 3-8, the pulse generation module 210 may also be at least W generated frequency signal of said stimulation pulses generated by the pulse generator 11. 进一步,请参见图9-12,所述脉冲发生模块210也具有上述脉冲发生器11的扫频功能。 Further, see Figure 9-12, the pulse generation block 210 also has the pulse generator 11 of the sweep function. 本发明的电脉冲刺激测试系统10通过引入变频刺激脉冲信号,可W用于测试患者是否适合采用变频刺激脉冲信号进行治疗。 Electrical pulse stimulation test system 10 of the present invention by introducing a stimulation pulse signal frequency, W can be used to test whether a patient stimulation pulse signal suitable for conversion treatment.

[0072] 本发明进一步提供一种采用上述变频刺激脉冲信号对目标神经进行刺激的方法, 该方法包括: 步骤SIO,确定该变频刺激脉冲信号的刺激频率;w及步骤S20,将该变频刺激脉冲信号作用于目标神经。 [0072] The present invention further provides a method of the inverter target nerve stimulation pulses to the stimulation signal, the method comprising the steps of: the SIO, determines the frequency of the stimulation signal frequency stimulation pulse; W and step S20, the stimulation pulses the frequency signal is applied to the target nerve.

[0073] 所述步骤S10中,本发明提供两种确定该变频刺激脉冲信号的刺激频率的方法。 [0073] In the step S10, the present invention provides a method for determining the stimulation frequency Two frequency stimulation pulse signal.

[0074] 方法一,对于已经采用恒定频率刺激一段时期,且附带一些不良症状的患者。 [0074] A method, a patient at a constant frequency stimulation period, and comes to a number of undesirable symptoms have been employed. 先记录该患者采用恒定频率刺激的正常使用频率A。 The previously recorded patient normally uses a constant frequency stimulation frequency A. 通常,不同患者采用恒定频率刺激的正常使用频率为确定值。 Typically, patients using a constant frequency different stimulation frequency is determined normal value. 然后,利用体外程控仪14对患者的脉冲发生器11进行控制,使之输出恒定频率的脉冲,观察患者的反映。 Then, using an in vitro patient programmer 14 pairs of pulse generator 11 is controlled so that the output pulses of constant frequency, reflecting the observation of the patient. 若患者在某一频率下不良症状得到改善,记录下该脉冲频率B。 If the patient at a frequency of adverse symptoms improved, the recording frequency of the pulse B. 根据公式;C=AVB计算得到一对应使用的频率C。 The equation; C = AVB calculated using a frequency corresponding to a C. 目P,该对应使用的频率C与不良症状得到改善的频率B的的几何平均值为正常使用频率A。 Geometric mean mesh P, corresponding to the frequency of C used in the frequency of adverse symptoms improved B is the normal frequency A. 所述频率B和频率C即为该变频刺激脉冲信号的刺激频率。 B and C of the frequency is the frequency of the stimulation pulse signal frequency stimulation frequency.

[00巧]可W理解,如果患者附带两种或两种W上不良症状,可W分别根据上述方法和公式得到对应使用的频率C、D等。 [00 Qiao] W can be appreciated, if the patient comes adverse symptoms on two or W, W may be used to give the corresponding frequency C, D, etc. according to the above methods and formulas. 所述频率B、C、D等即为该变频刺激脉冲信号的刺激频率。 The frequency of the stimulation frequency is the frequency of the stimulation pulse signals B, C, D and so on.

[0076] 方法二,该方法二与方法一基本相同,其区别为,根据公式;C=2A-B计算得到一对应使用的频率C。 [0076] The second method, a method with which two substantially identical, the difference is, according to the equation; C = 2A-B corresponds to a frequency calculated using C. 目P,该对应使用的频率C与不良症状得到改善的频率B的的算术平均值为正常使用频率A。 Head P, corresponding to the frequency of C used in the frequency of adverse symptoms improved B are arithmetic mean normal frequency A.

[0077] 方法H,对于首次采用电脉冲刺激进行治疗的患者。 [0077] Method H, for treating a patient using the first electrical pulse stimulation. 利用体外程控仪14对患者的脉冲发生器11进行控制,使该脉冲发生器11按照上述第一种单一频率扫频模式进行扫频, 输出不同的恒定频率的脉冲信号,并分别记录使患者不同症状得到改善的脉冲频率B和C。 Vitro patient programmer 14 pairs of pulse generator 11 is controlled so that the pulse generator 11 a pulse signal sweep frequency different output constant according to the above first single frequency sweep mode, and the patient are recorded in different symptoms improved pulse frequency B, and C. 所述频率B和频率C即为该变频刺激脉冲信号的刺激频率。 B and C of the frequency is the frequency of the stimulation pulse signal frequency stimulation frequency. 采用恒频刺激进行刺激找到患者症状得到改善的脉冲频率需要很短的时间,通常为十几砂到几分钟。 Using constant-frequency stimulation to stimulate the patient's symptoms improved find the pulse frequency very short period of time, usually a few minutes to more than a dozen sand.

[0078] 可W理解,如果患者患有H种或H种W不同症状,则分别记录患者不同症状得到改善的脉冲频率B、C、D…。 [0078] W can be appreciated, if the patient is suffering from one or H H W species different symptoms, the patient records are different symptoms improved frequency pulse B, C, D .... 所述频率B、C、D等即为该变频刺激脉冲信号的刺激频率。 The frequency of the stimulation frequency is the frequency of the stimulation pulse signals B, C, D and so on.

[0079] 进一步,采用上述方法获得的交替刺激脉冲信号的刺激频率B和C对患者的刺激并非是最优的。 [0079] Further, the use alternate stimulation pulse signal frequency obtained by the above method to stimulate B and C stimulate the patient is not optimal. 本发明还可WB和C为基准频率,通过上述第H种多频率交替组合扫频的模式进行扫频,W得到最优的刺激频率B和C。 The present invention also WB and the reference frequency C, the combination swept by the sweep mode alternately the first kind of multi-frequency H, W optimal stimulation frequency B, and C.

[0080] 所述步骤S20中,可W先设定不同频率的电刺激脉冲的时间比为1/N,其中,N为所述不同频率的电刺激脉冲的个数。 [0080] The step of S20, the W can be previously set time electrical stimulation pulses of different frequencies ratio of 1 / N, where, N is the number of said electrical stimulation pulses of different frequencies. 可W理解,可W根据实际需要对该变频刺激脉冲信号的参数进行调解。 W can be understood that the parameters W mediate stimulation frequency pulse signal according to the actual needs. 例如,如果某个症状改善不明显,则相应增加与该症状对应的刺激频率的时间占比,减少其他症状对应的刺激频率的时间占比,直到使患者的症状改善达到均衡。 For example, if a little improvement of symptoms, a corresponding increase in the proportion of time the stimulation frequency corresponding to the symptoms and reduce the proportion of time the stimulation frequency corresponding to the other symptoms, improve the symptoms of patients until equilibrium.

[0081] 在现有的刺激模式中,刺激波形为较高频率的恒定频率刺激,该恒定频率对患者的症状有改善,但不可避免地附带一些不良症状,且患者容易对该种恒定频率刺激产生适应性。 [0081] In the conventional mode of stimulation, stimulation waveform is a constant frequency of stimulation higher frequency, the constant frequency of the patient's symptoms improved, but inevitably comes with some adverse symptoms and the patient easily the kinds of constant frequency stimuli produced adaptability. 本发明通过引入变频刺激脉冲信号,在保证对患者的刺激效果前提下,能够改善或者消除不良症状。 The present invention is by introducing a stimulation pulse signal frequency, to ensure an effect of stimulus provided to the patient can be improved or eliminated undesirable symptoms.

[0082] 例如,临床中,帕金森患者植入脑起搏器对其丘脑底核进行刺激,能够显著改善其颤抖、身体僵硬等症状。 [0082] For example, clinical, Parkinson's patients implanted brain pacemaker to stimulate their subthalamic nucleus, can significantly improve tremors, stiffness and other physical symptoms. 然而,现有技术中,对丘脑底核的刺激为恒定频率的刺激。 However, the prior art, the stimulation of the subthalamic nucleus stimulation frequency is constant. 在长时间的刺激后,部分患者会产生起步困难、构音障碍等不良症状。 After a long period of stimulation, some patients will have initial difficulties, dysarthria and other adverse symptoms. 另外,长时间单一频率的刺激, 如100赫兹,使患者容易对该种刺激产生适应性,类似于患者对药物的适应性,刺激效果变差。 In addition, prolonged stimulation of a single frequency, such as 100 Hz, the adaptability of the patient prone to stimuli, drugs of similar adaptability to a patient, stimulating effect of variation.

[0083] 本发明已经用于改善帕金森患者由于长期恒定频率刺激导致的不良症状和适应性。 [0083] The present invention has been used to improve the long-term due to the constant frequency Parkinson's patients and adverse symptoms resulting from the adaptive stimulation. w下为应用本发明的实际案例。 W is the practical case of application of the present invention.

[0084] 案例1 帕金森患者X在长时间的100赫兹恒定频率刺激后,产生起步困难和构音障碍不良症状。 [0084] Case 1 X Parkinson's patients after prolonged stimulation of 100 Hz constant frequency, starting difficulties and to produce adverse symptoms dysarthria. 该患者X的正常使用频率A为100赫兹。 Normal use of the patient's X A frequency of 100 Hz.

[0085] 利用体外程控仪14对患者X的脉冲发生器11进行控制,使之输出恒定频率的脉冲,观察患者X的反映。 [0085] In vitro use of a pulse generator 14 pairs of patient programmer 11 controls the X, so that the output pulses of constant frequency, reflecting the observation of the patient X. 若患者X在某一频率下构音障碍的问题得到改善,记录下该脉冲频率B为80赫兹。 If the patient at a frequency X problem dysarthria improved recording frequency of the pulse B is at 80 hertz. 根据公式;C=AVB计算得到一对应使用的频率C为125赫兹。 The equation; C = AVB calculated using a frequency corresponding to a C of 125 Hz.

[0086] 采用80赫兹和125赫兹的变频刺激脉冲信号对患者X进行刺激治疗。 [0086] The stimulation pulse frequency 80 Hz and 125 Hz X stimulation therapy to a patient. 设定两种频率的时间占比均为50%,每个频率的电刺激脉冲在每个脉冲串中持续的时间为10砂。 Setting two frequencies are accounted for 50% of the time, the frequency of each electrical stimulation pulses in each burst duration time of the sand 10. 经过一段时间的刺激,观察患者X的症状的改善程度,构音障碍的状况得到明显的改善。 After a period of stimulation, the degree of improvement of the symptoms observed in patients with X, dysarthria situation has been significantly improved. 通过本发明的变频刺激,在保证治疗效果的前提下,对患者的不良症状进行改善。 , To ensure treatment at the premise of the adverse symptoms improved by the present invention frequency stimulation. W下是患者用普通恒频刺激与变频刺激得到的发声效果对比。 W is a lower frequency in patients with stimulation frequency sound effect is obtained by conventional constant stimulus contrast.

[0087] 表1恒频刺激与变频刺激的发声效率对比 [0087] Table 1 utterance efficiency constant frequency stimulation and stimulation frequency comparison

Figure CN104548349AD00131

案例2 帕金森患者Y患有肢体僵硬症状和起步困难症状,且首次采用电脉冲刺激进行治疗。 Case 2 Y Parkinson's patients suffer from symptoms of limbs stiff and difficult symptoms start, and for the first time the use of electrical stimulation treatment.

[0088] 根据患者Y的症状选择不同的恒频刺激频率,发现在100赫兹的恒频刺激下患者Y 的肢体僵硬症状得到明显的改善,且在130赫兹的恒频刺激下患者Y的起步困难症状得到一定改善。 [0088] Symptoms patient selection Y according to the different constant frequency stimulation frequency, found at constant frequency stimulation 100 Hz patient Y limb stiffness symptoms significantly improved, and at constant frequency stimulation of 130 Hz is difficult to start a patient Y, symptoms were improved.

[0089] 采用100赫兹和130赫兹的变频刺激脉冲信号对患者Y进行刺激治疗。 [0089] The stimulation pulse frequency 100 Hz and 130 Hz stimulation therapy to a patient Y. 设定两种频率的时间占比均为50%,每个频率的电刺激脉冲在每个脉冲串中持续的时间为20砂。 Setting two frequencies are accounted for 50% of the time, the frequency of each electrical stimulation pulses in each burst duration time of the sand 20. 观察患者症状的改善情况,发现起步困难得到明显的改善,但肢体僵硬改善不理想。 Observe the improvement of the patient's symptoms and found that the initial difficulties have been significantly improved, but the improvement is not satisfactory stiff limbs. 进一步, 调节130赫兹频率占比为60%,100赫兹频率占比为40%,再观察患者的改善情况,发现起步困难和肢体僵硬均得到明显的改善。 Further, adjusting the frequency of 130 Hz accounted for 60%, accounted for the frequency of 100 Hz of 40%, and then observed to improve the patient's condition was found difficult to start and limb rigidity were significantly improved.

[0090] 另外,本领域技术人员还可W在本发明精神内做其他变化,该些依据本发明精神所做的变化,都应包含在本发明所要求保护的范围内。 [0090] Additionally, one skilled in the art may make other changes W within the spirit of the present invention, the plurality of changes made according to the spirit of the present invention, the present invention is intended to be included within the scope of the claims.

Figure CN104548349AD00132

Claims (18)

1. 一种电脉冲刺激测试装置,其包括:一体外测试刺激器以及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其特征在于,所述脉冲发生模块至少可以产生变频刺激脉冲信号,该变频刺激脉冲信号包括至少两种不同频率的电刺激脉冲串交替刺激形成多个脉冲串周期,且每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为0. 1秒~30分钟。 An electrical stimulation pulse testing apparatus, comprising: an outer one and a test stimulation test leads, and the in vitro test stimulator comprises a pulse generation module, wherein at least said pulse generating module may generate a frequency stimulation pulses signal, the stimulation pulse frequency electrical stimulation signal comprises at least two pulse trains of different frequencies are alternately formed a plurality of stimulation burst period, and each frequency electrical stimulation burst duration of each burst cycle time of 0.1 seconds to 30 minutes.
2. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为3秒~60秒。 2. The electrical pulse stimulation test apparatus according to claim 1, characterized in that the electrical stimulation duration of each frequency burst in each burst cycle time of 3 seconds to 60 seconds.
3. 如权利要求2所述的电脉冲刺激测试装置,其特征在于,每个频率的电刺激脉冲串在每个脉冲串周期中持续的时间为5秒~30秒。 2 the electrical pulse claim stimulation test apparatus, wherein the electrical stimulation duration of each frequency burst in each burst cycle time is 5 seconds to 30 seconds.
4. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述电刺激脉冲串的频率为30赫兹~250赫兹。 The electrical pulses as claimed in claim 1 stimulation test apparatus, wherein the electrical stimulation burst frequency of 30 Hz to 250 Hz.
5. 如权利要求4所述的电脉冲刺激测试装置,其特征在于,所述电刺激脉冲串的频率为50赫兹~150赫兹。 5. The electrical pulse stimulation to claim 4, wherein the testing device, wherein the electrical stimulation burst frequency of 50 Hz to 150 Hz.
6. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述不同频率的电刺激脉冲串的个数为N,且2彡N〈10。 6. The electrical pulses of the stimulation test apparatus according to claim 1, wherein the number of different frequencies of the electrical stimulation pulse train is N, and 2 San N <10.
7. 如权利要求6所述的电脉冲刺激测试装置,其特征在于,所述不同频率的电刺激脉冲串的个数为2或3,且所述不同频率的电刺激脉冲串在每个脉冲串周期中的时间比大于20%。 7. The electrical pulses of the stimulation test apparatus according to claim 6, characterized in that the number of different frequencies, the electrical stimulation pulse train is 2 or 3, and the electrical stimulation pulses of different frequencies in each pulse train string time period is greater than 20%.
8. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述不同频率的电刺激脉串之间间隔一定时间,且相邻两个不同频率的电刺激脉冲串之间的时间间隔为〇. 01秒~60 秒。 8. The electrical pulse to the stimulation test apparatus of claim 1, characterized in that the time intervals between the different frequencies of electrical stimulation pulse train, and the time between two electrical stimulation pulse trains of different frequencies adjacent square interval 01 to 60 seconds.
9. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述多个脉冲串周期之间间隔一定时间,且相邻两个脉冲串周期之间的时间间隔为〇. 01秒~60秒。 9. The electrical pulse to the stimulation test apparatus of claim 1, characterized in that the time intervals between said plurality of burst periods, and the time period between two adjacent bursts interval is square. 01 seconds to 60 seconds.
10. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述脉冲发生模块具有扫频功能;当设定该扫频范围为Flmin~FImax,扫频精度为S1,扫描时间为T1,所述脉冲发生模块将以Flmin、Flmin+Sl、Flmin+2S1、Flmin+3S1 …Flmin+nSl、以及Flmax 分别输出一电刺激脉冲串,且每个电刺激脉冲串持续时间为Tl,其中,η为自然数,且n ^ (Flmax-Flmin)/SI〇 10. The electrical pulse stimulation test apparatus according to claim 1, wherein said pulse generating module having a sweep function; when the frequency sweep range is set Flmin ~ FImax, sweep accuracy as S1, the scan time is Tl, the pulse generating modules will Flmin, Flmin + Sl, Flmin + 2S1, Flmin + 3S1 ... Flmin + nSl, Flmax and outputs a burst of electrical stimulation, electrical stimulation and each burst duration Tl, wherein , [eta] is a natural number, and n ^ (Flmax-Flmin) / SI〇
11. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述脉冲发生模块具有扫频功能;当设定该扫频范围为F2min~F2max,扫频精度为S2,扫描时间为T2,所述脉冲发生模块将以F2min 和F2max、F2min+S2 和F2max-S2、F2min+2S2 和F2max-2S2 …以及F2min+nS2和F2max-nS2分别交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T2,其中,η为自然数,且n〈(F2max- F2min)/2S2。 11. The electrical pulse stimulation test apparatus according to claim 1, wherein said pulse generating module having a sweep function; when the frequency sweep range is set F2min ~ F2max, accuracy is swept S2, the scan time is T2, and the pulse module will F2min F2max occur, F2min + S2 and F2max-S2, F2min + 2S2 and F2max-2S2 ... + respectively and alternately outputs two pulse trains of electrical stimulation and nS2 F2max-nS2 F2min, and every two duration of electrical stimulation pulse train output alternately to T2, where, [eta] is a natural number and n <(F2max- F2min) / 2S2.
12. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述脉冲发生模块具有扫频功能;当设定基准频率为Fb 1和Fb2,扫频范围为F3,扫频精度为S3,以及扫描时间为T3, 所述脉冲发生模块将分别以Fbl和Fb2、Fbl+S3和Fb2、Fbl+2S3和Fb2…Fbl+nS3和Fb2、Fbl-S3 和Fb2、Fbl-2S3 和Fb2 …Fbl-nS3 和Fb2、Fbl 和Fb2+S3、Fbl 和Fb2+2S3 …Fbl和Fb2+nS3、Fbl和Fb2-S3、Fbl和Fb2-2S3…Fbl和Fb2-nS3交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T3,其中,η为自然数,且n =F3/ S3 ο 12. The electrical pulse stimulation test apparatus according to claim 1, wherein said pulse generating module having a sweep function; when set to 1 and Fb2 of the reference frequency, sweep range of Fb F3, accuracy is swept S3, and scan time T3, the pulse generator module, respectively Fbl and Fb2, Fbl + S3 and Fb2, Fbl + 2S3 and Fb2 ... Fbl + nS3 and Fb2, Fbl-S3 and Fb2, Fbl-2S3 and Fb2 of ... Fbl-nS3 and Fb2, Fbl and Fb2 + S3, Fbl and Fb2 + 2S3 ... Fbl and Fb2 + nS3, Fbl and Fb2-S3, Fbl and Fb2-2S3 ... Fbl Fb2-nS3 and alternately outputs two electrical stimulation pulse trains, and the duration of each stimulation pulse train alternately outputs two electrical is T3, where, [eta] is a natural number, and n = F3 / S3 ο
13. 如权利要求1所述的电脉冲刺激测试装置,其特征在于,所述脉冲发生模块具有扫频功能;当设定基准频率为Fb 1和Fb2,扫频范围为F3,扫频精度为S3,以及扫描时间为T3, 所述脉冲发生模块将分别以Fbl和Fb2、Fbl+S3和Fb2+S3、Fbl+2S3和Fb2+2S3…Fbl+nS3 和Fb2+nS3、Fbl-S3 和Fb2-S3、Fbl-2S3 和Fb2-2S3 …Fbl-nS3 和Fb2-nS3、Fbl+S3 和Fb2-S3、Fbl+2S3 和Fb2-2S3 …Fbl+nS3 和Fb2_nS3、Fbl_S3 和Fb2+S3、Fbl_2S3 和Fb2+2S3…Fbl-nS3和Fb2+nS3交替输出两个电刺激脉冲串,且每两个电刺激脉冲串交替输出的持续时间为T3,其中,η为自然数,且n =F3/S3。 13. The electrical pulse stimulation test apparatus according to claim 1, wherein said pulse generating module having a sweep function; when set to 1 and Fb2 of the reference frequency, sweep range of Fb F3, accuracy is swept S3, and scan time T3, the pulse generator module, respectively Fbl and Fb2, Fbl + S3 and Fb2 + S3, Fbl + 2S3 and Fb2 + 2S3 ... Fbl + nS3 and Fb2 + nS3, Fbl-S3 and Fb2- S3, Fbl-2S3 and Fb2-2S3 ... Fbl-nS3 and Fb2-nS3, Fbl + S3 and Fb2-S3, Fbl + 2S3 and Fb2-2S3 ... Fbl + nS3 and Fb2_nS3, Fbl_S3 and Fb2 + S3, Fbl_2S3 and Fb2 + 2S3 ... Fbl-nS3 Fb2 + nS3 and alternately outputs two electrical stimulation pulse trains, and the duration of each stimulation pulse train alternately outputs two electrical is T3, where, [eta] is a natural number, and n = F3 / S3.
14. 如权利要求12或13所述的电脉冲刺激测试装置,其特征在于,所述扫频范围F3为1赫兹~20赫兹,所述扫频精度S3为1赫兹~10赫兹,所述扫描的时间T3为5秒~60分钟可调。 14. The electrical stimulation pulse testing apparatus 12 or claim 13, wherein said sweep range F3 is 1 Hz to 20 Hz, said sweeping accuracy S3 1 Hz to 10 Hz, the scanning T3 time is 5 seconds to 60 minutes adjustable.
15. 如权利要求14所述的电脉冲刺激测试装置,其特征在于,所述扫频范围F3为5赫兹~1〇赫兹,所述扫频精度S3为2赫兹~5赫兹,所述扫描的时间T3为30秒~10分钟可调。 15. The electrical pulses of the stimulation test apparatus according to claim 14, characterized in that the sweep range of 5 Hz ~ F3 1〇 Hz, S3 accuracy of the swept 2 Hz to 5 Hz, the scan T3 time is 30 seconds to 10 minutes adjustable.
16. -种电脉冲刺激测试装置,其包括:一体外测试刺激器以及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其特征在于,所述脉冲发生模块至少可以产生变频刺激脉冲信号。 16. - kind of electrical stimulation test apparatus, comprising: an outer one and a test stimulation test leads, and the in vitro test stimulator comprises a pulse generation module, wherein at least said pulse generating module may generate a frequency stimulation pulses signal.
17. -种电脉冲刺激测试装置,其包括:一体外测试刺激器以及一测试导线,且该体外测试刺激器包括一脉冲发生模块,其特征在于,所述脉冲发生模块至少可以产生变频刺激脉冲信号,该变频刺激脉冲信号仅包括两种或三种不同频率的电刺激脉冲串交替刺激形成多个脉冲串周期。 17. - kind of electrical stimulation test apparatus, comprising: an outer one and a test stimulation test leads, and the in vitro test stimulator comprises a pulse generation module, wherein at least said pulse generating module may generate a frequency stimulation pulses signal, the stimulation pulse frequency signal includes only two or three different frequencies of electrical stimulation pulse train alternately stimulate the formation of a plurality of burst periods.
18. -种电脉冲刺激测试系统,其包括:一电脉冲刺激测试装置以及一刺激电极,其特征在于,所述电脉冲刺激测试装置为如上述权利要求1至17所述的电脉冲刺激测试装置中的任意一种。 18. - kind of electrical stimulation test system comprising: an electrical stimulation device and a test stimulation electrode, characterized in that the electrical stimulation pulse testing apparatus as described above for the electrical stimulation of claims 1 to 17 to test any device.
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