CN101495173A - 肠胃器官的随机刺激 - Google Patents

肠胃器官的随机刺激 Download PDF

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CN101495173A
CN101495173A CNA2006800384664A CN200680038466A CN101495173A CN 101495173 A CN101495173 A CN 101495173A CN A2006800384664 A CNA2006800384664 A CN A2006800384664A CN 200680038466 A CN200680038466 A CN 200680038466A CN 101495173 A CN101495173 A CN 101495173A
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parameter
signal
pulse
select
digestive organs
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米尔·A·伊姆兰
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IntraPace Inc
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IntraPace Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

提供一种用于刺激消化器官的设备、系统和方法,其中,所述刺激被随机化。

Description

肠胃器官的随机刺激
相关申请的交叉引用
本申请是正式申请,其要求美国专利申请No.11/219,004(申请日为1996年9月9日)的优先权,在这里通过引用将其全文并入。
技术领域
本发明涉及一种用于刺激胃壁的设备系统和方法。
背景技术
已经提出了多种设备来刺激胃的胃壁和其它肠胃器官。已经提出了各种不同的刺激参数。
然而,人们认为,利用现在已经提出的设备和刺激参数,肠胃或其它消化器官将适应刺激或变得对刺激不敏感,尤其是如果这种刺激以非生理速率被给予较长时间。因此,期望提供一种可以减少对刺激的适应和不敏感的消化器官刺激设备、系统和/或方法。
已经提出了一些使用具有定相关系的多个电极以便在一些情况下沿着蠕动流程来刺激消化道器官的设备。但是,也有人认为胃、肠胃或其它消化器官将随着时间适应这样的定相刺激。因此,期望提供一种可以减少对多个电极的刺激的适应和/或不敏感的消化器官刺激设备、系统和/或方法。
发明内容
本发明提供一种用于随机刺激消化器官的设备、系统和方法。
本发明的一个方面提供一种旨在减少消化器官对电刺激的适应或不敏感的设备系统和方法。根据本发明的一个方面,所述设备被编程为伪随机地选择刺激参数并给予消化器官伪随机刺激。这里所使用的伪随机意指包括在预设标准或限制内的随机选择。所述限制或标准可以包括例如在预选或预定刺激参数窗口内的刺激。也可以采用大量已知或专属方法和设备中的任何一个来计算、产生和/或选择伪随机参数。典型地,所选择的随机或伪随机刺激参数将典型地足够不规则或不定期,以抑制组织适应。
本发明包括如权利要求书中所请求的那些发明。
在下面的详细论述中描述本发明的各种实施例和各个方面。
附图说明
图1是已经应用于消化器官的示例性刺激信号的示意图。
图2是已经应用于消化器官的示例性刺激信号的示意图。
图3是使用多个电极的示例性定相刺激的示意图。
图4是根据本发明的刺激信号的示意图。
图5是根据本发明的刺激信号的示意图。
图6是根据本发明的刺激信号的示意图。
图7是根据本发明的刺激信号的示意图。
图8是根据本发明的刺激信号的示意图。
图9是根据本发明的刺激信号的示意图。
图10是说明根据本发明的刺激设备的操作的流程图。
图11是说明根据本发明的刺激设备的操作的流程图。
图12是根据本发明的刺激设备。
具体实施方式
根据本发明的一个方面,提供一种用于刺激消化器官的设备。所述设备可以刺激任何一个或多个消化器官,例如包括分泌消化物质、消化调节激素等等的部分胃肠道或消化器官。根据一个实施例,提供一种用于刺激胃的设备。
可以提供刺激以引起一个或多个期望的效果或反应。可以提供刺激来控制消化、产生过饱的感觉、控制食物在胃肠道内的移动、调节消化过程或调节饥饿等等。这样的刺激设备的一个示例描述于美国专利No.6,535,764中,在这里通过引用将其并入。
根据本发明的一个方面,提供一种设备,其被编程为随机地(或伪随机地)选择或改变一个或多个刺激参数,并根据选择的参数给予消化器官刺激。根据一个方面,随机地(或伪随机地)选择或改变刺激,以减少消化器官对刺激(尤其是以非生理速率的刺激)的适应或不敏感。
被编程的设备可以随机地(或伪随机地)从可接受参数的窗口或随机化窗口内选择或产生参数。这种参数可以包括但不局限于例如脉冲宽度、脉冲重复率、脉冲串频率、脉冲串重复率、每个脉冲串的脉冲。被编程的设备还可以在窗口内或根据选择标准随机地(或伪随机地)选择或改变脉冲幅值、脉冲形状和脉冲串包络。被编程的设备可以在刺激之前或刺激期间随机地(或伪随机地)选择或改变这些参数或其它参数中的任何一个或多个。
被编程的设备也可以随机地(或伪随机地)逐个脉冲或逐个脉冲串地选择或改变刺激。被编程的设备可以操作为周期性地改变参数,或者可以响应于感测到正在发生适应或不敏感或者刺激正在失效或接收到这样的反馈而改变参数。根据本发明的一个方面,例如,所述设备可以使用收缩监测设备(例如应变仪或其它收缩传感器)来监测随着时间的刺激响应。如果设备检测到次最优刺激响应,则设备接着可以随机或伪随机地选择下一个参数或参数集。
根据本发明的另一方面,所述被编程的设备可以在多个刺激点随机地(或伪随机地)选择或改变刺激。这些点中的每一个可以具有电分离的刺激电极,其中每个点处的刺激参数独立于其它点处的刺激。也可以随机地(或伪随机地)选择或改变刺激序列或序列的定时。因此,在各个点处没有特定的刺激定相。
参考图1,示出了已经用于刺激消化器官的典型刺激信号的示例。所述信号包括一系列脉冲。所述脉冲具有脉冲幅值PA1、脉冲宽度PW1,并以脉冲重复率PRR1重复。所述脉冲重复率是一个脉冲的启动时间到下一个脉冲的启动时间。所述参数通常被预设,或者被选择或选取用于处理。
参考图2,示出了已经用于刺激消化道器官的典型刺激信号的示例。所述信号包括脉冲的重复脉冲串的图案,其以脉冲串重复率BRR2重复。也就是说,所述脉冲串重复率是一个脉冲串的启动时间到下一个脉冲串的启动时间。脉冲串内的脉冲具有脉冲幅值PA和脉冲串频率BF2。所述脉冲串持续时间为BD2,并且每个脉冲串包括一定数量的脉冲PPB2。所述参数通常被预设,或者被选择用于处理。
参考图3,示出了典型的多电极刺激的示例。通过电极1给予刺激信号。电极2处的刺激相对于电极1处的刺激信号以相位角Ψ定相,Ψ表示启动电极1处的信号和启动电极2处的信号之间的时间。电极1和电极2处的信号也可以重叠。
图4示出了根据本发明的随机化刺激信号的示例,其可以由被编程设备随机地(或伪随机地)选择并给予消化器官。图4中所示的信号的脉冲宽度随机地变化,第一脉冲宽度为PWa,第二脉冲宽度为PWb,第三为PWc,以及第四为PWd。这些脉冲宽度被选择并给予。所述脉冲宽度可以在脉冲宽度的预选范围内。例如,在一个变化中,它们可以从每分钟1-20个脉冲变化。
图5示出信号的示例,其由被编程的设备随机地(或伪随机地)选择并由根据本发明的设备或系统给予。所述脉冲以变化和随机速率重复。第一脉冲的脉冲重复率为PRRa,此后第二脉冲被启动。第二脉冲的脉冲重复率为PRRb,此后第三脉冲被启动。第三脉冲的脉冲重复率为PRRc,此后第四脉冲被启动。第四脉冲的脉冲重速率为PRRd,此后第五脉冲被启动。第五脉冲的脉冲重复率为PRRe,此后第六脉冲被启动。所述脉冲宽度或其它参数也可以变化或不变化。
图6示出随机化信号的示例,其可以由根据本发明的被编程设备或系统随机地(或伪随机地)选择并给予。所述刺激信号包括一系列脉冲的脉冲串。脉冲的脉冲串以变化的随机速率重复。第一脉冲串的脉冲串重复率为BRRa,第二脉冲串的脉冲串重复率为BRRb,并且第三脉冲串的脉冲串重复率为BRRc。所述脉冲串频率或其它参数也可以变化。
图7示出随机化信号的示例,其可以由根据本发明的被编程设备或系统随机地(或伪随机地)选择并给予。所述刺激信号包括一系列脉冲的脉冲串。脉冲串的频率是随机变化的。脉冲的第一脉冲串的频率为BFa,脉冲的第二脉冲串的频率为BFb,脉冲的第三脉冲串的频率为BFc。其它参数也可以变化。
图8示出随机化信号的示例,其可以由根据本发明的系统设备随机地(或伪随机地)选择并给予。所述刺激信号包括一系列脉冲的脉冲串。脉冲的频率和脉冲串的重复率二者均随机变化。第一脉冲串的频率为BFd,脉冲串重复率为BRRd。第二脉冲串的频率为BFe,脉冲串重复率为BRRe。第三脉冲串的频率为BFf,脉冲串重复率为BRRf。
图4-8所示的随机化信号是一些可在刺激信号协议中随机化的参数的示例。可在任何一个处理协议中随机化这些参数中的任何一个或多个。所述随机化参数可以包括但不局限于下列参数中的一个或多个:脉冲宽度、脉冲幅值、脉冲重复率、脉冲串频率、脉冲串重复率。而且,每个脉冲(包括脉冲串内的脉冲)的形状可以变化。脉冲串的脉冲的包络形状可以变化。脉冲的脉冲串内的频率、脉冲宽度和幅值也可以变化。而且,一些参数可以变化同时其它参数保持不变。
各个随机化的参数可以由随机数发生器或控制器从参数窗口或参数组内随机地(或伪随机地)选择。所述参数窗口或参数组可被预先编程到刺激设备中并在处理过程中被随机地选择。
图9示出信号的随机化,例如参考图4-8所述的那些,其在多个电极点被随机施加。如图9所示,在第一时间周期t1内,在时刻ta在电极1处施加第一脉冲p1,在时刻tb在电极2处施加第二脉冲p2。在时间周期t2内,在随机的不同时刻在电极1处施加脉冲p3并在电极2处施加脉冲p4。类似地,在时间周期t3和t4内,在不同时刻在电极1和电极2处施加脉冲。
现在参考图12,示出根据本发明的刺激器120的示意图。消化器官刺激器可以包括任何刺激器,其包含电耦合至消化器官并被配置成给予消化器官刺激信号的电极。这样的刺激器的一个示例是配置成刺激胃的包括至少一个耦合至胃的电极和耦合至所述电极的脉冲发生器的设备。这样的电极可被植入胃,例如经过腹腔镜或内窥镜的开放手术。
如图12所示,根据本发明的一个示例的刺激器120包括CPU21,其包括具有查找表123的存储器设备122,其中刺激参数与例如在随机数范围内的随机数相关联。随机数发生器124耦合至CPU121,并且当被提示时,随机地产生对应于特定刺激参数的范围内的数。所述随机数发生器例如可以具有100个可能的随机数对应于给定类型的不同参数(例如1-100用于脉冲重复率以及101-200用于脉冲宽度等等)。所述随机数发生器也可以具有某些随机数,每一个对应于将给予的特定预定信号,所述信号可以改变一个或多个参数,或者可以具有刺激信号的变化形状或类型。
所产生的随机数标识刺激参数或存储在存储器设备122的查找表123中的参数。然后,CPU 121控制刺激输出125(例如至一个或多个电极)处的刺激,以向消化器官给予刺激,其中所述刺激对应于随机地(或伪随机地)产生或选择的刺激参数。可以使用一个以上的查找表和随机数发生器,其中多个刺激参数被随机化。
图10示出根据本发明的设备的示例性方法和操作。首先,在随机数的范围内产生随机数(100)。每个随机数对应于参数窗口或范围内的特定刺激信号或刺激参数(或参数组)。具有对应于所产生的随机数的参数的脉冲或脉冲串被产生并给予消化器官用于刺激(101)。然后,计时器被开启,以标识何时第一信号已被启动(102),以及对应于刺激参数(或参数组)的特定刺激信号再次产生随机数(103)。并且,对于何时将给予下一个刺激脉冲或脉冲串进行计算(104)。给予时间的计算可以取决于哪个刺激参数正被随机化。如果脉冲重复率或脉冲串重复率是变化参数,则何时将分别给予下一个脉冲或脉冲串的计算将基于脉冲或脉冲串重复率的变化。如果脉冲重复率或脉冲串重复率是不变的,则所述给予时间的计算将是不变的或者基于不变的脉冲或脉冲串重复率。如果所述随机化将周期性地发生,则根据具有第一组刺激图案的协议给予刺激,直到计时器所确定的某个周期已经发生。当所述周期已经发生时,接下来根据刺激协议使用下一个随机化的刺激参数。如果刺激协议涉及在各种条件下打开或关闭刺激,则在打开刺激时开启计时器,并在关闭刺激时关掉计时器。作为选择,计时器可以连续地运转。
比较给予下一个信号的时间和计时器的时间(当前一个脉冲或脉冲串开始时),以确定是否是给予下一个脉冲或脉冲串的时间。如果不是给予下一个脉冲或脉冲串的时间(106),则再次进行比较(105),直到是给予下一个脉冲或脉冲串的时间(106),随之产生具有对应于所产生的随机数的参数的信号(101),并且重复步骤102-106。
图11示出根据本发明的设备的方法和操作。首先,在随机数的范围内产生用于电极1的随机数(110)。然后,在随机数的范围内产生用于电极2的随机数(111)。每个随机数对应于特定刺激信号或参数窗口或范围内的刺激参数(或参数组)。然后,当脉冲或脉冲串周期开始时开启计时器(112)。具有对应于每个产生的用于电极1和2的随机数的参数的脉冲或脉冲串被产生并给予消化器官,用于在电极1和2处相应地刺激(113)。这些刺激信号彼此独立。但是,它们可以被定时以便落入预定脉冲重复率内,使得总体上在下一组刺激信号被给予电极1和2之前,每个刺激信号在预设时间周期内被给予。因此,如步骤112中所阐明的,启动计时器来识别第一脉冲周期的开始。然后确定预设时间是否已经过去(114),此时重复步骤111到114。
虽然已经参考一些实施例描述了本发明,但是可以理解,可以在权利要求的范围内作出变化和修改。这样的修改可以包括替换元件或组件,其以基本上相同的方式执行基本上相同的功能以实现基本上相同的结果,而本发明在权利要求范围内通过修改可以得以实践。

Claims (19)

1、一种消化器官刺激器,包括:
刺激信号发生器;
信号选择器,耦合至所述信号发生器并被配置成随机或伪随机地选择至少一个信号参数;以及
刺激输出,被配置成耦合至消化器官,其中,所述刺激发生器被配置成通过所述刺激输出,输出包括至少一个所选信号参数的刺激信号。
2、权利要求1所述的消化器官刺激器,其中,所述信号选择器包括伪随机信号选择器,其被配置成伪随机地选择所述至少一个信号参数。
3、权利要求1所述的消化器官刺激器,其中,所述至少一个所选信号参数是从包括下列参数的组中选择的:脉冲宽度、脉冲重复率、脉冲串频率和脉冲串重复率。
4、权利要求1所述的消化器官刺激器,其中,所述至少一个所选信号参数是从信号参数的预定组中选择的。
5、权利要求1所述的消化器官刺激器,还包括:
多个输出,其中,所述信号选择器被配置成选择将给予其的所述多个输出的每一个的信号参数。
6、权利要求1所述的设备,其中,所述信号选择器被配置成选择多个参数类型的每一个的参数。
7、权利要求1所述的设备,其中,所述刺激输出包括电极。
8、权利要求1所述的设备,其中,所述刺激输出包括被配置成耦合至胃肠道的电极。
9、权利要求1所述的设备,其中,所述刺激输出包括被配置成耦合至胃的电极。
10、权利要求1所述的设备,还包括传感器,被配置成感测对于器官刺激的响应,其中,所述传感器耦合至信号选择器,其中,信号选择器被配置成当传感器没有感测到对于刺激的适当响应时,随机或伪随机地选择新的参数。
11、一种刺激消化器官的方法,包括步骤:
提供电耦合至消化器官的刺激器;
随机或伪随机地选择用于消化器官的刺激的参数;以及
给予消化器官包括所选参数的刺激信号。
12、权利要求11所述的方法,其中,选择参数的步骤包括:伪随机地选择参数。
13、权利要求12所述的方法,其中,选择参数的步骤包括:产生对应于参数的随机数,并基于所述随机数来确定随机参数。
14、权利要求11所述的方法,其中,选择参数的步骤包括:随机地选择参数窗口内的参数。
15、权利要求11所述的方法,其中,选择参数的步骤包括:从第一类型的参数中选择第一参数和从第二类型的参数中选择第二参数;以及
其中,给予刺激信号的步骤包括:给予消化器官包括第一参数和第二参数的刺激信号。
16、权利要求11所述的方法,还包括步骤:
感测消化器官对于刺激信号的响应;
确定消化器官的响应是否处于期望范围内;以及
如果消化器官的响应不处于期望范围内,则随机或伪随机地选择新的参数。
17、权利要求11所述的方法,给予消化器官刺激信号的步骤包括:向胃肠道的一部分给予所述信号。
18、权利要求17所述的方法,其中,给予胃肠道所述信号的步骤包括:向胃给予信号以产生过饱的感觉。
19、权利要求11所述的方法,
其中,提供电耦合至消化器官的刺激器的步骤包括:提供电耦合至消化器官的多个点的刺激器;
其中,选择用于消化器官的刺激的参数的步骤包括:随机或伪随机地选择用于多个点的每一个处的刺激的独立参数;以及
其中,给予消化器官包括参数的刺激信号的步骤包括:给予包括用于多个点的每一个的独立参数的刺激信号,其中,一个点处的每个独立参数是与给予所述多个点的其它点的其它独立参数无关地选择的。
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US8032223B2 (en) 2011-10-04
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