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CN111420276A - Implanted nerve stimulation equipment and system with frequency conversion function - Google Patents

Implanted nerve stimulation equipment and system with frequency conversion function
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CN111420276A
CN111420276ACN202010209055.9ACN202010209055ACN111420276ACN 111420276 ACN111420276 ACN 111420276ACN 202010209055 ACN202010209055 ACN 202010209055ACN 111420276 ACN111420276 ACN 111420276A
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frequency conversion
stimulation
conversion parameters
frequency
parameter
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马伯志
郝红伟
李青峰
陈浩
李路明
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Beijing Pinchi Medical Equipment Co ltd
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Tsinghua University
Beijing Pins Medical Co Ltd
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Abstract

Translated fromChinese

本发明提供一种具有变频功能的植入式神经刺激设备及系统,所述设备包括控制单元、参数存储单元和输出单元;其中所述参数存储单元用于存储多组变频参数,所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数;所述控制单元用于获取至少两组所述变频参数,并根据至少两组所述变频参数控制输出单元输出相应的至少两种脉冲序列。

Figure 202010209055

The present invention provides an implantable neurostimulation device and system with frequency conversion function. The device includes a control unit, a parameter storage unit and an output unit; wherein the parameter storage unit is used to store multiple sets of frequency conversion parameters, and the frequency conversion parameters Including the stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point, and duration; the control unit is used to obtain at least two sets of the frequency conversion parameters, and control the output unit output according to the at least two sets of the frequency conversion parameters corresponding at least two pulse sequences.

Figure 202010209055

Description

Translated fromChinese
具有变频功能的植入式神经刺激设备及系统Implantable nerve stimulation device and system with frequency conversion function

技术领域technical field

本发明涉及植入式医疗设备领域,具体涉及一种具有变频功能的植入式神经刺激设备及系统。The invention relates to the field of implantable medical equipment, in particular to an implantable nerve stimulation device and system with frequency conversion function.

背景技术Background technique

传统的植入式脑深部刺激器(DBS)多采用单一固定频率的脉冲刺激。然而临床研究表明,DBS对部分帕金森患者的震颤、僵直、反应迟钝和姿态不稳的症状没有明显治疗效果。对于另外一些患者,DBS可能带来认知功能减退、抑郁、语言功能障碍、平衡能力下降等副作用,使患者出现记忆力减退、发音困难、容易跌倒等症状。而且,一旦患者对固定频率的刺激出现适应性,治疗效果就会随时间而下降。Traditional implantable deep brain stimulators (DBS) mostly use a single fixed frequency pulse stimulation. However, clinical studies have shown that DBS has no significant therapeutic effect on the symptoms of tremor, rigidity, unresponsiveness and postural instability in some Parkinson's patients. For other patients, DBS may bring about side effects such as cognitive decline, depression, language dysfunction, and decreased balance ability, resulting in symptoms such as memory loss, dysphonia, and easy falling. Moreover, once the patient becomes acclimated to a fixed frequency of stimulation, the therapeutic effect declines over time.

目前,一些DBS试图通过提高刺激频率来解决无效的问题,但是持续高频刺激也有许多弊端。首先,提高刺激频率也提高了副作用的风险。其次,持续高频刺激增大功耗造成设备使用寿命缩短。最后,持续高频刺激仍是使用单一频率,并不能解决治疗效果因患者产生适应而降低的问题。At present, some DBS try to solve the problem of ineffectiveness by increasing the stimulation frequency, but continuous high-frequency stimulation also has many disadvantages. First, increasing stimulation frequency also increases the risk of side effects. Second, continuous high-frequency stimulation increases power consumption and shortens the service life of the device. Finally, continuous high-frequency stimulation still uses a single frequency, and does not solve the problem that the treatment effect is reduced due to the patient's adaptation.

发明内容SUMMARY OF THE INVENTION

有鉴于此,本发明提供一种具有变频功能的植入式神经刺激设备,包括控制单元、参数存储单元和输出单元;其中所述参数存储单元用于存储多组变频参数,所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数;所述控制单元用于获取至少两组所述变频参数,并根据至少两组所述变频参数控制输出单元输出相应的至少两种脉冲序列。In view of this, the present invention provides an implantable nerve stimulation device with a frequency conversion function, including a control unit, a parameter storage unit and an output unit; wherein the parameter storage unit is used to store multiple sets of frequency conversion parameters, and the frequency conversion parameters include Stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point, and duration; the control unit is configured to acquire at least two sets of the frequency conversion parameters, and control the output unit to output the corresponding frequency conversion parameters according to at least two sets of the frequency conversion parameters. of at least two pulse sequences.

可选地,所述控制单元用于依次循环使用至少两组所述变频参数控制输出单元依次循环输出相应的至少两种脉冲序列。Optionally, the control unit is configured to cyclically use at least two groups of the frequency conversion parameters to control the output unit to output the corresponding at least two pulse sequences cyclically in turn.

可选地,所述参数存储单元用于存储多个刺激程序组,每个刺激程序组包括多组变频参数;所述控制单元用于选择一个刺激程序组,利用所选刺激程序组的多组变频参数控制输出单元输出相应的多种脉冲序列。Optionally, the parameter storage unit is used to store multiple stimulation program groups, and each stimulation program group includes multiple groups of frequency conversion parameters; the control unit is used to select a stimulation program group, using multiple groups of the selected stimulation program group. The frequency conversion parameter controls the output unit to output corresponding various pulse sequences.

可选地,所述变频参数还包括间隔时间,用于指示下一个脉冲序列与当前输出的脉冲序列间的相隔时间。Optionally, the frequency conversion parameter further includes an interval time, which is used to indicate the interval time between the next pulse sequence and the currently output pulse sequence.

可选地,所述设备还包括通信单元,用于连接体外程控设备,以使其设置所述参数存储单元中的变频参数。Optionally, the device further includes a communication unit for connecting to an external program-controlled device, so that it can set the frequency conversion parameters in the parameter storage unit.

本发明还提供一种植入式神经刺激设备的控制方法,包括:The present invention also provides a control method for the implantable nerve stimulation device, comprising:

确定至少两组变频参数,所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数;determining at least two groups of frequency conversion parameters, the frequency conversion parameters including stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point, and duration;

根据所述至少两组变频参数产生相应的两种脉冲序列。Two corresponding pulse sequences are generated according to the at least two sets of frequency conversion parameters.

可选地,所确定使用的各组变频参数中的刺激频率均不相同。Optionally, the stimulation frequencies in each group of frequency conversion parameters determined to be used are different.

可选地,所确定使用的各组变频参数中除刺激频率外的参数至少部分不同。Optionally, the parameters other than the stimulation frequency among the groups of frequency conversion parameters determined to be used are at least partially different.

可选地,所述变频参数还包括间隔时间,用于指示下一个脉冲序列与当前产生的脉冲序列间的相隔时间;根据所述至少两组变频参数产生相应的两种脉冲序列,包括:Optionally, the frequency conversion parameter further includes an interval time, which is used to indicate the interval time between the next pulse sequence and the currently generated pulse sequence; according to the at least two sets of frequency conversion parameters, two corresponding pulse sequences are generated, including:

在利用当前变频参数输出相应的脉冲序列后计时;Timing after using the current frequency conversion parameters to output the corresponding pulse sequence;

当计时达到当前变频参数的间隔时间时,利用下一个变频参数产生相应的脉冲序列。When the timing reaches the interval time of the current frequency conversion parameter, the next frequency conversion parameter is used to generate the corresponding pulse sequence.

本发明还提供一种植入式神经刺激系统,包括权上述刺激设备以及体外程控设备,所述体外程控设备用于设定所述变频参数。The present invention also provides an implantable nerve stimulation system, comprising the above-mentioned stimulation device and an external program control device, wherein the external program control device is used to set the frequency conversion parameter.

根据本发明实施例提供的变频刺激设备,其参数存储单元可被配置多组变频参数,其中有多个刺激频率及其与多个幅度、脉宽、刺激触点、持续时间参数的组合,控制单元通过采用多组变频参数可以使输出单元输出多种相应的脉冲序列,由此提供了更多的刺激手段,能够更好地适应不同临床需求,尤其对于脊髓刺激治疗疼痛有潜在的价值。According to the frequency conversion stimulation device provided by the embodiment of the present invention, its parameter storage unit can be configured with multiple sets of frequency conversion parameters, wherein there are multiple stimulation frequencies and combinations thereof with multiple amplitude, pulse width, stimulation contact, and duration parameters to control By using multiple sets of frequency conversion parameters, the output unit can output a variety of corresponding pulse sequences, thereby providing more stimulation methods and better adapting to different clinical needs, especially for spinal cord stimulation treatment of pain potential value.

根据本发明实施例提供的变频刺激方法,通过采用多个刺激频率及其与多个幅度、脉宽、刺激触点、持续时间参数的结合,可以输出多种相应的脉冲序列,由此提供了更多的刺激手段,能够更好地适应不同临床需求,尤其对于脊髓刺激治疗疼痛有潜在的价值。According to the frequency conversion stimulation method provided by the embodiment of the present invention, by using multiple stimulation frequencies and their combination with multiple amplitude, pulse width, stimulation contact, and duration parameters, multiple corresponding pulse sequences can be output, thereby providing More stimulation methods can better adapt to different clinical needs, especially for spinal cord stimulation to treat pain.

附图说明Description of drawings

为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to illustrate the specific embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the specific embodiments or the prior art. Obviously, the accompanying drawings in the following description The drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

图1为本发明实施例中的植入式神经刺激系统的示意图;1 is a schematic diagram of an implantable nerve stimulation system in an embodiment of the present invention;

图2为本发明实施例中的多种脉冲序列的示意图;2 is a schematic diagram of various pulse sequences in an embodiment of the present invention;

图3为本发明实施例中的脉冲序列组合示意图;3 is a schematic diagram of a pulse sequence combination in an embodiment of the present invention;

图4为本发明实施例中的植入式神经刺激设备的示意图;4 is a schematic diagram of an implantable nerve stimulation device in an embodiment of the present invention;

图5为本发明实施例中一种优选的植入式神经刺激设备的示意图。FIG. 5 is a schematic diagram of a preferred implantable nerve stimulation device in an embodiment of the present invention.

具体实施方式Detailed ways

下面将结合附图对本发明的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

在本发明的描述中,需要说明的是,术语“第一”、“第二”等仅用于描述目的,而不能理解为指示或暗示相对重要性。此外,下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。In the description of the present invention, it should be noted that the terms "first", "second" and the like are only used for the purpose of description, and should not be construed as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

本发明实施例提供一种植入式神经刺激设备的变频刺激方法,本申请所述刺激设备包括但不限于脊髓刺激设备和脑深部电刺激设备。如图1示出本方法可以由体外程控设备1、刺激器2或者二者配合执行:Embodiments of the present invention provide a variable frequency stimulation method for an implantable neurostimulation device. The stimulation devices described in this application include but are not limited to spinal cord stimulation devices and deep brain stimulation devices. As shown in FIG. 1 , this method can be performed by an external program-controlled device 1, astimulator 2, or both:

确定至少两组变频参数。本申请所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间这四个参数中的至少一个参数。一组变频参数至少包括刺激频率和另外至少一种参数。为了便于理解,本实施例以同时包括刺激频率、幅度、脉宽、刺激触点、持续时间这5个参数进行说明,比如有n组变频参数,第1组变频参数为[频率f1,幅度a1,脉宽w1,刺激触点p1,持续时间t1]、第2组变频参数为[频率f2,幅度a2,脉宽w2,刺激触点p2,持续时间t2]、……、第n组变频参数为[频率fn,幅度an,脉宽wn,刺激触点pn,持续时间tn]。Determine at least two sets of frequency conversion parameters. The frequency conversion parameters described in this application include stimulation frequency, and at least one parameter among the four parameters of amplitude, pulse width, stimulation contact point, and duration. A set of variable frequency parameters includes at least the stimulation frequency and at least one other parameter. For ease of understanding, this embodiment is described with five parameters including stimulation frequency, amplitude, pulse width, stimulation contact point, and duration. For example, there are n groups of frequency conversion parameters, and the first group of frequency conversion parameters is [frequency f1, amplitude a1 , pulse width w1, stimulation contact p1, duration t1], the second group of frequency conversion parameters is [frequency f2, amplitude a2, pulse width w2, stimulation contact p2, duration t2], ..., the nth group of frequency conversion parameters is [frequency fn, amplitude an, pulse width wn, stimulation contact pn, duration tn].

每一组变频参数可决定一种相应的脉冲序列,脉冲序列由多个脉冲信号组成,上述参数中的刺激频率是指脉冲序列的频率,幅度是指脉冲序列中的各个脉冲信号的极值,脉宽是指脉冲序列中的各个脉冲信号达到极值所持续的时间,持续时间是指输出脉冲序列的时长。Each set of frequency conversion parameters can determine a corresponding pulse sequence. The pulse sequence is composed of multiple pulse signals. The stimulation frequency in the above parameters refers to the frequency of the pulse sequence, and the amplitude refers to the extreme value of each pulse signal in the pulse sequence. The pulse width refers to the time during which each pulse signal in the pulse sequence reaches the extreme value, and the duration refers to the duration of the output pulse sequence.

关于刺激触点,刺激器2一般包括多个通道,每个通道上设有多个刺激触点(电极),它们均可用于输出脉冲序列,以对人体内(比如脑深部或脊髓)的不同位置进行电刺激。本申请的变频参数中的刺激触点用于指示由哪个触点输出脉冲序列。比如刺激器2共有16个刺激触点,变频参数中的刺激触点参数用于指示由16个触点中的哪一个或几个触点输出脉冲序列。作为示例性的说明,假设某组变频参数中的刺激触点参数为“1、3、5”,频率为1kHz,脉宽为50us,持续时间为1s,其含义是指示第1、3、5这三个触点,以频率为1kHz、脉宽为50us输出脉冲序列,持续1s。Regarding the stimulation contacts, thestimulator 2 generally includes a plurality of channels, and each channel is provided with a plurality of stimulation contacts (electrodes), all of which can be used to output a pulse sequence, so as to respond to different conditions in the human body (such as the deep brain or the spinal cord). location for electrical stimulation. The stimulation contact in the variable frequency parameter of this application is used to indicate which contact outputs the pulse sequence. For example, thestimulator 2 has a total of 16 stimulation contacts, and the stimulation contact parameter in the frequency conversion parameter is used to indicate which one or several contacts among the 16 contacts output the pulse sequence. As an exemplary illustration, it is assumed that the stimulation contact parameters in a certain group of frequency conversion parameters are "1, 3, 5", the frequency is 1kHz, the pulse width is 50us, and the duration is 1s. These three contacts output a pulse sequence with a frequency of 1kHz and a pulse width of 50us for 1s.

确定变频参数后,根据确定的多组变频参数输出相应的多种脉冲序列。比如共确定使用3组不同的变频参数,根据上述说明可知其能够对应如图2所示的3种脉冲序列。作为一个具体举例,比如第1组变频参数为[频率10kHz,脉宽30us,持续时间100ms]、第2组变频参数为[频率1kHz,脉宽50us,持续时间1s]、第3组变频参数为[频率40Hz,脉宽210us,持续时间10s]。After determining the frequency conversion parameters, output corresponding various pulse sequences according to the determined groups of frequency conversion parameters. For example, three groups of different frequency conversion parameters are determined to be used. According to the above description, it can be known that they can correspond to the three kinds of pulse sequences shown in FIG. 2 . As a specific example, for example, the first group of frequency conversion parameters is [frequency 10kHz, pulse width 30us, duration 100ms], the second group of frequency conversion parameters is [frequency 1kHz, pulse width 50us, duration 1s], the third group of frequency conversion parameters is [Frequency 40Hz, pulse width 210us, duration 10s].

与确定使用的多组变频参数相应的多种脉冲序列应当是交替输出,也即多组变频参数应当被交替使用,但不限定使用顺序。比如对于图2所示的三种脉冲序列,简称为脉冲A、B、C,既可以按照3组变频参数的顺序输出A-B-C,也可以不按顺序输出C-B-A,或者输出B-A-C等等。Various pulse sequences corresponding to the multiple sets of frequency conversion parameters determined to be used should be output alternately, that is, multiple sets of frequency conversion parameters should be used alternately, but the order of use is not limited. For example, for the three pulse sequences shown in Figure 2, referred to as pulses A, B, and C for short, A-B-C can be output in the order of the three groups of frequency conversion parameters, or C-B-A can be output out of sequence, or B-A-C can be output, and so on.

实际使用时这些变频参数可以被人为设定,为了确保变频效果,设备所使用的多组变频参数中,应当有至少部分组中的刺激频率是不相等的。作为优选的实施例,所确定使用的各组变频参数中的刺激频率均不相同,比如上述3组变频参数,其中的刺激频率分别为10kHz、1kHz和40Hz。其它诸如幅度、脉宽、刺激触点、持续时间参数可以部分不同、均不相同或相同。In actual use, these frequency conversion parameters can be set manually. In order to ensure the frequency conversion effect, among the multiple groups of frequency conversion parameters used by the device, the stimulation frequencies in at least some of the groups should be unequal. As a preferred embodiment, the stimulation frequencies in each group of frequency conversion parameters determined to be used are different, for example, the stimulation frequencies of the above three groups of frequency conversion parameters are 10 kHz, 1 kHz and 40 Hz, respectively. Other parameters such as amplitude, pulse width, stimulation contacts, duration may be partially different, all different or the same.

为了确保脉冲序列的频率对大多数患者有效,应当使刺激频率在设定范围内,也就是应当使刺激器2输出的脉冲序列的频率在一个安全有效的范围以内,该范围是2Hz-20kHz。在应用于脑深部刺激器时该范围是2Hz至250Hz。In order to ensure that the frequency of the pulse sequence is effective for most patients, the stimulation frequency should be within the set range, that is, the frequency of the pulse sequence output by thestimulator 2 should be within a safe and effective range, which is 2Hz-20kHz. The range is 2 Hz to 250 Hz when applied to deep brain stimulators.

上述持续时间的取值范围可以为1ms-24h。幅度的取值范围可以是0-10V或者0-25mA。脉冲宽度的取值范围为20us-1000us。用户可以在上述范围内设置变频参数。另外,不同频率下的刺激波形可以根据需要,设定为被动电荷平衡或者主动电荷平衡。The value range of the above duration time may be 1ms-24h. The value range of the amplitude can be 0-10V or 0-25mA. The value range of the pulse width is 20us-1000us. The user can set the frequency conversion parameters within the above range. In addition, the stimulation waveforms at different frequencies can be set to passive charge balance or active charge balance as required.

根据本发明实施例提供的变频刺激方法,通过采用多个刺激频率及其与多个幅度、脉宽、刺激触点、持续时间参数的结合,可以输出多种相应的脉冲序列,由此提供了更多的刺激手段,能够更好地适应不同临床需求,尤其对于脊髓刺激治疗疼痛有潜在的价值。According to the frequency conversion stimulation method provided by the embodiment of the present invention, by using multiple stimulation frequencies and their combination with multiple amplitude, pulse width, stimulation contact, and duration parameters, multiple corresponding pulse sequences can be output, thereby providing More stimulation methods can better adapt to different clinical needs, especially for spinal cord stimulation to treat pain.

在一个优选的实施例中,变频参数还包括间隔时间,该时间用于指示下一个脉冲序列与当前输出的脉冲序列间的相隔时间,间隔时间的范围为0-100秒。由此,利用多组变频参数输出相应的两种脉冲序列的过程可描述为:在利用当前变频参数输出相应的脉冲序列后进行计时;当计时达到当前变频参数的间隔时间时,利用下一个变频参数输出相应的脉冲序列。如图3所示,当使用第1组变频参数输出脉冲序列A后,即持续时间达到100ms后开始计时,假设第1组变频参数中的间隔时间为T1,则在计时达到T1时,使用第2组变频参数输出脉冲序列B。类似地,脉冲序列B完毕后计时达到T2时,使用第3组变频参数输出脉冲序列C,完毕后在计时达到T3时,使用下一组变频参数输出相应的脉冲序列。In a preferred embodiment, the frequency conversion parameter further includes an interval time, which is used to indicate the interval time between the next pulse sequence and the currently output pulse sequence, and the interval time ranges from 0 to 100 seconds. Therefore, the process of using multiple sets of frequency conversion parameters to output the corresponding two pulse sequences can be described as: timing after using the current frequency conversion parameters to output the corresponding pulse sequences; when the timing reaches the interval time of the current frequency conversion parameters, use the next frequency conversion parameter The parameter outputs the corresponding pulse train. As shown in Figure 3, when the first group of frequency conversion parameters is used to output the pulse sequence A, that is, the timing starts after the duration reaches 100ms. Assuming that the interval time in the first group of frequency conversion parameters is T1, when the timing reaches T1, the first 2 groups of frequency conversion parameters output pulse sequence B. Similarly, when the timing reaches T2 after the completion of the pulse sequence B, the third group of frequency conversion parameters is used to output the pulse sequence C, and when the timing reaches T3, the next group of frequency conversion parameters is used to output the corresponding pulse sequence.

上述优选方案使得各种脉冲序列间的相隔时间可以被分别设定,各组变频参数中的间隔时间可以完全不同、部分相同或相同,由此可以进一步丰富刺激手段。The above preferred solution enables the interval time between various pulse sequences to be set separately, and the interval time in each group of frequency conversion parameters can be completely different, partially the same or the same, thereby further enriching the stimulation methods.

为了提高效率和便利性,可以依次循环使用多组变频参数输出相应的多种脉冲序列。比如对于上述举例,在使用第3组变频参数输出脉冲序列C完毕后,则重新使用第1组变频参数输出脉冲序列A,由此使刺激器2循环输出脉冲序列A-B-C-A-B-C……。In order to improve efficiency and convenience, multiple sets of frequency conversion parameters can be used in sequence to output corresponding multiple pulse sequences. For example, for the above example, after using the third group of frequency conversion parameters to output the pulse sequence C, the first group of frequency conversion parameters is used again to output the pulse sequence A, so that thestimulator 2 outputs the pulse sequence A-B-C-A-B-C . . .

本发明实施例还提供一种具有变频功能的植入式神经刺激设备,具体可以是脊髓刺激设备或者脑深部电刺激设备。如图4所示,作为植入人体内的刺激器,该设备包括控制单元41、参数存储单元42和输出单元43,输出单元43连接多个用于输出脉冲序列的电极。参数存储单元41用于存储多组变频参数,包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数。控制单元41用于获取至少两组变频参数,并根据至少两组变频参数控制输出单元43输出相应的至少两种脉冲序列。变频参数与脉冲序列的对应关系相关内容可参考上述方法,此处不再赘述。Embodiments of the present invention further provide an implantable nerve stimulation device with a frequency conversion function, which may be a spinal cord stimulation device or a deep brain electrical stimulation device. As shown in FIG. 4 , as a stimulator implanted in a human body, the device includes acontrol unit 41 , aparameter storage unit 42 and anoutput unit 43 , and theoutput unit 43 is connected to a plurality of electrodes for outputting pulse sequences. Theparameter storage unit 41 is used to store multiple sets of frequency conversion parameters, including stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point, and duration. Thecontrol unit 41 is configured to acquire at least two sets of frequency conversion parameters, and control theoutput unit 43 to output at least two corresponding pulse sequences according to the at least two sets of frequency conversion parameters. For the content related to the corresponding relationship between the frequency conversion parameters and the pulse sequence, reference may be made to the above method, which will not be repeated here.

刺激设备还包括通信单元44,用于连接体外程控设备进行无线通信,用户可通过体外设备设置参数存储单元42中的变频参数,比如新增、修改或删除各种变频参数以及其他参数等等。The stimulation device also includes acommunication unit 44 for connecting to the external program-controlled device for wireless communication. The user can set the frequency conversion parameters in theparameter storage unit 42 through the external device, such as adding, modifying or deleting various frequency conversion parameters and other parameters.

根据本发明实施例提供的变频刺激设备,其参数存储单元可被配置多组变频参数,其中有多个刺激频率及其与多个幅度、脉宽、刺激触点、持续时间参数的组合,控制单元通过采用多组变频参数可以使输出单元输出多种相应的脉冲序列,由此提供了更多的刺激手段,能够更好地适应不同临床需求,尤其对于脊髓刺激治疗疼痛有潜在的价值。According to the frequency conversion stimulation device provided by the embodiment of the present invention, its parameter storage unit can be configured with multiple sets of frequency conversion parameters, wherein there are multiple stimulation frequencies and combinations thereof with multiple amplitude, pulse width, stimulation contact, and duration parameters to control By using multiple sets of frequency conversion parameters, the output unit can output a variety of corresponding pulse sequences, thereby providing more stimulation methods and better adapting to different clinical needs, especially for spinal cord stimulation treatment of pain potential value.

鉴于实际使用时参数存储单元42中存储的变频参数的组数有限,可以设置控制单元41依次循环使用至少两组所述变频参数控制输出单元43依次循环输出相应的至少两种脉冲序列。In view of the limited number of groups of frequency conversion parameters stored in theparameter storage unit 42 in actual use, thecontrol unit 41 can be set to use at least two groups of the frequency conversion parameters in sequence to control theoutput unit 43 to output at least two corresponding pulse sequences in sequence.

在优选的实施例中,变频参数还包括间隔时间,用于指示下一个脉冲序列与当前输出的脉冲序列间的相隔时间。关于间隔时间的使用方式可参考上述方法,此处不再赘述。In a preferred embodiment, the frequency conversion parameter further includes an interval time, which is used to indicate the interval time between the next pulse sequence and the currently output pulse sequence. For the usage of the interval time, reference may be made to the above method, which will not be repeated here.

如图5所示,在一个实施例中,参数存储单元具体为参数寄存器52,其中配置多个刺激程序组1…程序组m,每个刺激程序组分别可配置多组变频参数。在本实施例中同时包括刺激频率、幅度、脉宽、刺激触点、持续时间这5种变频参数。比如程序组1中可配置刺激频率11…刺激频率1n、幅度11…幅度1n、脉宽11…脉宽1n、刺激触点11…刺激触点1n、持续时间11…持续时间1n;程序组m中可配置刺激频率m1…刺激频率mn、幅度m1…幅度mn、脉宽m1…脉宽mn、刺激触点m1…刺激触点mn、持续时间m1…持续时间mn。在实际产品中,程序组的数量可以为1-16个,程序组中的变频参数组数可以为1-16个。用户可以分别设置这些程序组,以及其中的变频参数。As shown in FIG. 5 , in one embodiment, the parameter storage unit is specifically aparameter register 52 , in which multiple stimulation program groups 1 . . . program groups m are configured, and each stimulation program group can be configured with multiple groups of frequency conversion parameters. In this embodiment, five frequency conversion parameters, namely, stimulation frequency, amplitude, pulse width, stimulation contact point, and duration, are also included. For example, in program group 1, you can configure stimulation frequency11 ... stimulation frequency1n , amplitude11 ... amplitude1n , pulse width11 ... pulse width1n , stimulation contact11 ... stimulation contact1n , duration11 ... duration1n ; program group m Stimulation frequencym1 ...stimulation frequencymn , amplitudem1 ...amplitudemn , pulse widthm1 ...pulse widthmn , stimulation contactm1 ...stimulation contactmn , durationm1 ...durationmn . In actual products, the number of program groups can be 1-16, and the number of variable frequency parameter groups in the program group can be 1-16. Users can set these program groups and the frequency conversion parameters in them separately.

控制单元具体为逻辑与控制电路51,通过选定一个刺激程序组,并利用所选刺激程序组中的多组变频参数控制刺激脉冲输出电路53(输出单元)输出相应的多种脉冲序列。根据上述优选方案,用户可以对刺激器设置多个程序组,刺激器采用某个程序组中的全部参数进行变频刺激,当需要切换变频参数时,可以切换为使用另一个程序组,即可完成对大量变频参数的切换操作,本方案具有较强的便利性和实用性。The control unit is specifically the logic andcontrol circuit 51, which controls the stimulation pulse output circuit 53 (output unit) to output corresponding various pulse sequences by selecting a stimulation program group and using multiple sets of frequency conversion parameters in the selected stimulation program group. According to the above preferred solution, the user can set multiple program groups for the stimulator, and the stimulator uses all parameters in a certain program group to perform frequency conversion stimulation. For the switching operation of a large number of frequency conversion parameters, this scheme has strong convenience and practicability.

本发明提供的刺激器刺激设备也可以兼容单一频率的刺激模式,比如控制单元只选择一组所述变频参数(唯一的刺激频率等参数)即可只输出唯一的一种脉冲序列。用户可以在变频模式和单一频率模式间进行切换,当切换为变频模式时即可执行上述方法进行变频刺激。The stimulator stimulation device provided by the present invention can also be compatible with a single-frequency stimulation mode. For example, the control unit only selects a set of the frequency conversion parameters (parameters such as a unique stimulation frequency) to output only a unique pulse sequence. The user can switch between the frequency conversion mode and the single frequency mode, and when switching to the frequency conversion mode, the above method can be performed to perform frequency conversion stimulation.

本领域内的技术人员应明白,本发明的实施例可提供为方法、系统、或计算机程序产品。因此,本发明可采用完全硬件实施例、完全软件实施例、或结合软件和硬件方面的实施例的形式。而且,本发明可采用在一个或多个其中包含有计算机可用程序代码的计算机可用存储介质(包括但不限于磁盘存储器、CD-ROM、光学存储器等)上实施的计算机程序产品的形式。As will be appreciated by one skilled in the art, embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, etc.) having computer-usable program code embodied therein.

本发明是参照根据本发明实施例的方法、设备(系统)、和计算机程序产品的流程图和/或方框图来描述的。应理解可由计算机程序指令实现流程图和/或方框图中的每一流程和/或方框、以及流程图和/或方框图中的流程和/或方框的结合。可提供这些计算机程序指令到通用计算机、专用计算机、嵌入式处理机或其他可编程数据处理设备的微控制器以产生一个机器,使得通过计算机或其他可编程数据处理设备的微控制器执行的指令产生用于实现在流程图一个流程或多个流程和/或方框图一个方框或多个方框中指定的功能的装置。The present invention is described with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each flow and/or block in the flowchart illustrations and/or block diagrams, and combinations of flows and/or blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a general purpose computer, special purpose computer, embedded processor or microcontroller of other programmable data processing device to produce a machine that causes the instructions to be executed by the microcontroller of the computer or other programmable data processing device Means are created for implementing the functions specified in the flow or flows of the flowcharts and/or the blocks or blocks of the block diagrams.

这些计算机程序指令也可存储在能引导计算机或其他可编程数据处理设备以特定方式工作的计算机可读存储器中,使得存储在该计算机可读存储器中的指令产生包括指令装置的制造品,该指令装置实现在流程图一个流程或多个流程和/或方框图一个方框或多个方框中指定的功能。These computer program instructions may also be stored in a computer-readable memory capable of directing a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory result in an article of manufacture comprising instruction means, the instructions The apparatus implements the functions specified in the flow or flow of the flowcharts and/or the block or blocks of the block diagrams.

这些计算机程序指令也可装载到计算机或其他可编程数据处理设备上,使得在计算机或其他可编程设备上执行一系列操作步骤以产生计算机实现的处理,从而在计算机或其他可编程设备上执行的指令提供用于实现在流程图一个流程或多个流程和/或方框图一个方框或多个方框中指定的功能的步骤。These computer program instructions can also be loaded on a computer or other programmable data processing device to cause a series of operational steps to be performed on the computer or other programmable device to produce a computer-implemented process such that The instructions provide steps for implementing the functions specified in the flow or blocks of the flowcharts and/or the block or blocks of the block diagrams.

显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。Obviously, the above-mentioned embodiments are only examples for clear description, and are not intended to limit the implementation manner. For those of ordinary skill in the art, changes or modifications in other different forms can also be made on the basis of the above description. There is no need and cannot be exhaustive of all implementations here. And the obvious changes or changes derived from this are still within the protection scope of the present invention.

Claims (10)

Translated fromChinese
1.一种具有变频功能的植入式神经刺激设备,其特征在于,包括控制单元、参数存储单元和输出单元;其中所述参数存储单元用于存储多组变频参数,所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数;所述控制单元用于获取至少两组所述变频参数,并根据至少两组所述变频参数控制输出单元输出相应的至少两种脉冲序列。1. An implantable neurostimulation device with frequency conversion function, characterized in that, comprising a control unit, a parameter storage unit and an output unit; wherein the parameter storage unit is used to store multiple groups of frequency conversion parameters, and the frequency conversion parameters include stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact, and duration; the control unit is used to obtain at least two sets of the frequency conversion parameters, and control the output unit to output the corresponding frequency conversion parameters according to the at least two sets of the frequency conversion parameters. At least two pulse sequences.2.根据权利要求1所述的设备,其特征在于,所述控制单元用于依次循环使用至少两组所述变频参数控制输出单元依次循环输出相应的至少两种脉冲序列。2 . The device according to claim 1 , wherein the control unit is configured to use at least two groups of the frequency conversion parameters to control the output unit to output the corresponding at least two pulse sequences in sequence. 3 .3.根据权利要求1或2所述的设备,其特征在于,所述参数存储单元用于存储多个刺激程序组,每个刺激程序组包括多组变频参数;所述控制单元用于选择一个刺激程序组,利用所选刺激程序组的多组变频参数控制输出单元输出相应的多种脉冲序列。3. The device according to claim 1 or 2, wherein the parameter storage unit is used to store multiple stimulation program groups, and each stimulation program group includes multiple groups of frequency conversion parameters; the control unit is used to select a Stimulation program group, using multiple groups of frequency conversion parameters of the selected stimulation program group to control the output unit to output corresponding various pulse sequences.4.根据权利要求1所述的设备,其特征在于,所述变频参数还包括间隔时间,用于指示下一个脉冲序列与当前输出的脉冲序列间的相隔时间。4 . The device according to claim 1 , wherein the frequency conversion parameter further comprises an interval time, which is used to indicate the interval time between the next pulse sequence and the currently output pulse sequence. 5 .5.根据权利要求1所述的设备,其特征在于,所述设备还包括通信单元,用于连接体外程控设备,以使其设置所述参数存储单元中的变频参数。5 . The device according to claim 1 , wherein the device further comprises a communication unit for connecting to an external program-controlled device, so as to set the frequency conversion parameters in the parameter storage unit. 6 .6.一种植入式神经刺激设备的控制方法,其特征在于,包括:6. A control method of an implantable nerve stimulation device, characterized in that, comprising:确定至少两组变频参数,所述变频参数包括刺激频率,以及幅度、脉宽、刺激触点、持续时间中的至少一个参数;determining at least two groups of frequency conversion parameters, the frequency conversion parameters including stimulation frequency, and at least one parameter of amplitude, pulse width, stimulation contact point, and duration;根据所述至少两组变频参数产生相应的两种脉冲序列。Two corresponding pulse sequences are generated according to the at least two sets of frequency conversion parameters.7.根据权利要求6所述的方法,其特征在于,所确定使用的各组变频参数中的刺激频率均不相同。7 . The method according to claim 6 , wherein the stimulation frequencies in each group of frequency conversion parameters determined to be used are different. 8 .8.根据权利要求7所述的方法,其特征在于,所确定使用的各组变频参数中除刺激频率外的参数至少部分不同。8 . The method according to claim 7 , wherein the parameters other than the stimulation frequency among the groups of frequency conversion parameters determined to be used are at least partially different. 9 .9.根据权利要求6所述的方法,其特征在于,所述变频参数还包括间隔时间,用于指示下一个脉冲序列与当前产生的脉冲序列间的相隔时间;根据所述至少两组变频参数产生相应的两种脉冲序列,包括:9 . The method according to claim 6 , wherein the frequency conversion parameter further comprises an interval time, which is used to indicate the interval time between the next pulse sequence and the currently generated pulse sequence; according to the at least two sets of frequency conversion parameters Two corresponding pulse trains are generated, including:在利用当前变频参数产生相应的脉冲序列后计时;Timing after using the current frequency conversion parameters to generate the corresponding pulse sequence;当计时达到当前变频参数的间隔时间时,利用下一个变频参数产生相应的脉冲序列。When the timing reaches the interval time of the current frequency conversion parameter, the next frequency conversion parameter is used to generate the corresponding pulse sequence.10.一种植入式神经刺激系统,其特征在于,包括权利要求1-5中任一项所述的刺激设备,以及体外程控设备,所述体外程控设备用于设定所述变频参数。10. An implantable neurostimulation system, characterized in that it comprises the stimulation device according to any one of claims 1-5, and an in vitro programmed control device, wherein the in vitro programmed control device is used to set the frequency conversion parameter.
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