CN101536942A - 用于测量胃限制系统中的阻抗的方法和装置 - Google Patents

用于测量胃限制系统中的阻抗的方法和装置 Download PDF

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CN101536942A
CN101536942A CN200910003265A CN200910003265A CN101536942A CN 101536942 A CN101536942 A CN 101536942A CN 200910003265 A CN200910003265 A CN 200910003265A CN 200910003265 A CN200910003265 A CN 200910003265A CN 101536942 A CN101536942 A CN 101536942A
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M·S·奥尔蒂茨
D·F·小德卢戈斯
A·L·玛科特
D·N·普莱西亚
D·C·耶茨
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Abstract

本发明涉及用于收集与可植入的限制装置有关的阻抗数据的方法和装置，更具体地说涉及用于测量胃限制系统中的阻抗的方法和装置。一般而言，所述方法和装置可使患者、健康护理员和其他人能够使用收集的数据作为反馈机制，以非限制性的方式监控患者体内的可植入的限制装置的效力并且确定、修改和/或出具考虑到收集的数据的患者治疗计划。靠近限制装置的组织例如在胃束带和患者胃之间的脂肪垫的阻抗数据可被收集并分析。与组织接触的电极可测量组织的阻抗，电极之间的阻抗随着组织尺寸的减少例如脂肪细胞收缩、和/或结构的变化而变化。

Description

用于测量胃限制系统中的阻抗的方法和装置
技术领域
本发明涉及用于收集与可植入的限制系统有关的阻抗数据的装置和方法。
背景技术
特别是在美国，随着肥胖人数持续增加，并且所知道的肥胖对健康的负面影响越来越多，肥胖变得越来越受到关注。人的体重超过理想体重100磅或者更多的病理性肥胖尤其引起严重健康问题的极大风险。因此，大量的注意力被聚焦到治疗肥胖患者上。治疗病理性肥胖的一种方法是围绕胃的上部设置限制装置，诸如细长的束带。胃束带典型地包括具有固定端点的填充了流体的弹性囊，该囊紧邻食道-胃结合部的下部围绕胃，以便在束带上方形成小的胃袋并在胃中形成减小了的人造口。当流体注入囊中时，束带抵靠胃膨胀，从而在胃中形成食物摄取限制部分或者人造口。为了减少这种限制，将流体从束带中去除。束带的作用是减小可利用的胃的容积，并由此在变得“饱胀”之前减少可被消耗掉的食物量。
食物限制装置还包括类似地围绕胃上部的以机械方式调节的胃束带。这些胃束带包括任意数量的弹性材料或者传动装置以及驱动装置，以便调节胃束带。另外，胃束带已经被发展为包括液压和机械驱动元件。这样的可调节胃束带的例子在2000年5月30日公告的题为“Mechanical Food Intake Restriction Device”的美国专利No.6067991中公开，该文献的内容通过引用而包含在本申请中。还已知的是，通过将可膨胀的弹性囊植入到胃腔本身中来限制胃腔中可用的食物容积。囊填充有流体以便抵靠胃壁膨胀，并且由此减少胃内可用的食物容积。
使用上述食物限制装置的每一种进行安全有效的处理都要求所述装置被有规律地监测并调节以改变施加到胃上的限制程度。使用束带装置，在最初植入之后束带上方的胃袋的尺寸显著增加。因此，胃中的人造口最初必须被形成得大到足以使患者能够接收充足养分，同时胃能够适应束带装置。随着胃袋尺寸增加，束带可被调节以改变人造口的尺寸。另外，需要改变人造口的尺寸以便适应患者身体或者治疗状况的变化，或者在更紧急的情况下，减轻梗阻或者严重食管扩张。传统地，调节液压胃束带要求在休伯针和注射器被用于穿刺患者皮肤并经注射端口将流体加入到囊中或者从囊中除去期间按照规定看医生。最近，已经发展了能够以非侵入方式调节束带的可植入泵。外部程序装置使用遥感技术与植入的泵通信，以便对泵进行控制。在按照规定看医生期间，医生将程序装置的手持部分放置在胃植入物附近并将功率信号和命令信号传递给植入物。植入物又调节束带中的流体水平并将响应命令传递给程序装置。
在这些胃束带的调节过程中，难以确定调节进行得怎样，以及调节是否具有所需效果。在用于确定调节效力的尝试中，一些医生采用在正进行调节时吞咽钡的透视法。但是，透视法很昂贵并且由于医生和患者都承受照射量而是不期望的。其他医生指示患者在调节过程中或之后饮用一杯水以确定水是否通过调节的人造口。但是，水法仅仅保证了患者不被阻碍，而不能提供有关调节效力的任何信息。通常，医生基于他们的已有经验可简单地采用“尽可能尝试”法，调节的结果可能直到数小时或者数天后当患者经历了对胃腔的完全阻碍时或者胃束带由于邻靠着束带的过大的交界面压力而导致胃组织的侵蚀时才被揭示。
发明内容
因此，提供了与可植入的限制装置一起使用的方法和装置，特别是用于收集与可植入的限制装置有关的阻抗数据的方法和装置。
本发明总的涉及用于收集与可植入的限制装置有关的阻抗数据的方法和装置。在一种实施方式中，用于在患者体内形成限制的限制系统被设置成包括用于在患者体内形成限制的可植入的限制装置(例如可调节的胃束带)。该系统还包括阻抗测量装置以及设置在可植入的限制装置的组织接触表面上的至少两个传感器电极，所述阻抗测量装置能够与传感器电极形成电子通信并且测量传感器电极之间的阻抗。在一些实施方式中，传感器电极能够与由可植入的限制装置形成的限制附近的组织接触，并且阻抗测量装置能够测量组织的阻抗。
该系统还可以包括可将在传感器电极之间测量的阻抗与一阻抗值范围比较的处理器。在一些实施方式中，该系统包括当阻抗测量装置在传感器电极之间测得的阻抗不同于阻抗阈值和/或阻抗值范围时能够发出校正动作的信号(例如，建议改变可植入的限制装置内的压力和/或修改患者的治疗计划)的处理器。阻抗阈值能够反映由可植入的限制装置形成的限制附近的组织的基线量。与阻抗阈值不同的测量阻抗值可指示患者体重减轻和患者体重增加中的任一项。在一些实施方式中，处理器也可以确定在一段时间内收集的测量阻抗值是否每个都处于指示体重减轻停滞(weight loss plateau)的基本定值，如果是则发出警报信号。
在另一种实施方式中，用于在患者体内形成限制的限制系统包括可植入的测量装置，该可植入的测量装置可以与能够在患者体内形成限制的可植入的限制装置通信。可植入的测量装置还可以收集与患者的体重有关的数据。该系统还包括在收集到的数据表明与患者体重有关的拐点(例如曲线中表明患者的脂肪垫最小化的拐点)时发出信号来调节与可植入的限制装置有关的患者治疗的控制器。用于调节患者治疗的信号可以包括例如用于调节可植入的限制装置内的流体量的信号和/或用于修改患者的治疗计划的信号。在一些实施方式中，系统还包括能够感测可植入的限制装置内的流体压力并且将压力数据传送至控制器的压力传感器。控制器能够使用压力数据来确证患者体重的拐点，并且如果被确证则发出信号来调节患者的治疗。在一些实施方式中，测量装置包括阻抗测量装置以及设置在可植入的限制装置的组织接触表面上的至少两个传感器电极，该阻抗测量装置能够与传感器电极形成电子通信并且测量传感器电极之间的阻抗。传感器电极可以与由可植入的限制装置形成的限制附近的组织接触，并且阻抗测量装置能够测量组织的阻抗。如果测量阻抗落在阻抗值范围内，那么控制器能够发送信号来改变可植入的限制装置内的流体体积。
在其他方面中，提供了一种用于控制患者的体重减轻的方法。该方法包括提供限制装置，该限制装置能够被植入患者体内并且具有设置在可植入的限制装置的组织接触表面上的至少两个电极。该方法还包括使用阻抗传感器测量被限制装置包围的组织的阻抗。在一些实施方式中，该方法还包括将阻抗传感器联接到限制装置的组织接触表面上。组织的测量阻抗和组织的前一测量阻抗之间的差别可以指示食物团和两个电极之间的组织褶皱中的至少一个。在一些实施方式中，该方法还包括在测量阻抗不同于阻抗阈值、落在阻抗值范围以外时或者在一段时间内收集的测量阻抗值每个都处于指示体重减轻停滞的基本定值时启动报警信号。启动报警信号可以包括将信号传输至外部显示装置，该外部显示装置能够显示出指示测量阻抗不同于阻抗阈值、落在阻抗值范围以外或者指示体重减轻停滞的通知。作为补充或替代，该方法可以包括在报警信号被启动时调节限制装置内的流体量。
更具体地说，本发明涉及如下内容：
(1).一种用于在患者体内形成限制的限制系统，包括：
可植入的限制装置，其用于在患者体内形成限制；
至少两个传感器电极，其设置在所述可植入的限制装置的组织接触表面上；以及
阻抗测量装置，其与所述传感器电极电子通信并且用于测量所述传感器电极之间的阻抗。
(2).根据第(1)项所述的系统，其中，所述可植入的限制装置包括可调节的胃束带。
(3).根据第(1)项所述的系统，还包括处理器，该处理器用于将在所述传感器电极之间测量的阻抗与阻抗值范围进行比较。
(4).根据第(1)项所述的系统，其中，所述传感器电极被构造成与由所述可植入的限制装置形成的限制附近的组织接触，并且所述阻抗测量装置用于测量所述组织的阻抗。
(5).根据第(1)项所述的系统，还包括处理器，该处理器用于在所述阻抗测量装置测量到所述传感器电极之间的阻抗不同于阻抗阈值时发出校正动作的信号。
(6).根据第(5)项所述的系统，其中，所述阻抗阈值反映接近由所述可植入的限制装置形成的限制的组织的基线量。
(7).根据第(5)项所述的系统，其中，在所述传感器电极之间测量的不同于阻抗阈值的阻抗值指示患者体重减轻或患者体重增加。
(8).根据第(5)项所述的系统，其中，所述处理器被用于确定在一段时间内收集的测量阻抗值是否都处于指示体重减轻停滞的基本定值，如果是这样的话就发出报警信号。
(9).根据第(5)项所述的系统，其中，所述校正动作包括建议改变所述可植入的限制装置内的压力。
(10).根据第(5)项所述的系统，其中，所述校正动作包括建议修改患者的治疗计划。
(11).一种用于在患者体内形成限制的限制系统，包括：
可植入的测量装置，其与用于在患者体内形成限制的可植入的限制装置通信并且收集与患者的体重相关的数据；以及
控制器，其用于在所收集的数据指示与患者体重有关的拐点时发出调节与可植入的限制装置有关的患者治疗的信号。
(12).根据第(11)项所述的系统，其中，所述测量装置包括设置在所述可植入的限制装置的组织接触表面上的至少两个传感器电极，以及与所述传感器电极电子通信并且用于测量所述传感器电极之间阻抗的阻抗测量装置。
(13).根据第(12)项所述的系统，其中，所述传感器电极被构造成与由所述可植入的限制装置形成的限制附近的组织接触，并且所述阻抗测量装置用于测量所述组织的阻抗。
(14).根据第(13)项所述的系统，其中，所述控制器用于在测量的阻抗落在阻抗值范围内时发出信号以改变所述可植入的限制装置内的流体体积。
(15).根据第(11)项所述的系统，其中，所述控制器用于分析收集到的数据以得到曲线中指示患者脂肪垫最小化的拐点。
(16).根据第(11)项所述的系统，还包括用于感测所述可植入的限制装置内的流体压力并且将压力数据传输给所述控制器的压力传感器，其中所述控制器被构造成使用所述压力数据来确证与患者体重有关的拐点并且在确证拐点后发出用于调节患者的治疗的信号。
(17).根据第(11)项所述的系统，其中，所述用于调节患者的治疗的信号包括用于调节所述可植入的限制装置内的流体量的信号。
(18).根据第(11)项所述的系统，其中，所述用于调节患者的治疗的信号包括用于改变患者的治疗计划的信号。
(19).一种用于控制患者体重减轻的方法，包括：
提供可植入的限制装置，其可植入到患者体内并且具有位于其组织接触表面上的至少两个电极；以及
使用阻抗传感器测量由所述限制装置围绕的组织的阻抗。
(20).根据第(19)项所述的方法，还包括将所述阻抗传感器连接到所述限制装置的组织接触表面上。
(21).根据第(19)项所述的方法，还包括在测量的阻抗不同于阻抗阈值或者落在阻抗值范围以外时启动警报信号。
(22).根据第(21)项所述的方法，其中，启动警报信号包括将信号传输到外部的显示装置，该显示装置用于显示指示测量阻抗不同于阈值阻抗或者落在阻抗值范围以外的通知。
(23).根据第(21)项所述的方法，还包括在警报信号被启动时调节所述限制装置内的流体量。
(24).根据第(19)项所述的方法，还包括在一段时间内收集的测量阻抗值都处于指示体重减轻停滞的基本定值时启动警报信号。
(25).根据第(19)项所述的方法，其中，组织的测量阻抗和组织的前一个测量阻抗之间的差别指示两个电极之间的组织褶皱和食物团的至少一个。
附图说明
通过以下结合附图的详细描述将更全面地理解本发明，其中：
图1A是食物摄入限制系统的一种实施方式的示意图；
图1B是图1A的食物摄入限制系统的可植入部分的一种实施方式的透视图；
图2A是图1A的食物摄入限制装置的透视图；
图2B是图2A的食物摄入限制装置被施加在患者的胃食管结合部周围时的示意图；
图3是图1A的注射端口外壳的实施方式的透视图；
图4是图1A的传感器外壳的实施方式的透视图；
图5是图1A的食物摄入限制装置的内部元件和外部元件的实施方式的框图；
图6是联接到图1A的食物摄入限制装置上的电极的实施方式的示意图；
图7是图6的电极和食物摄入限制装置的局部图；
图8是图6的电极和食物摄入限制装置的另一局部图；
图9是包括电压激励源的电路的实施方式；
图10是包括电流激励源的电路的实施方式；
图11是患者体重减轻的测量拐点的实施方式的图表；
图12是与组织接触的电极的实施方式的示意图；
图13是示出了由图6的电极收集的数据的数据分析方案的实施方式的框图；
图14是用于记录与图1A的食物摄入限制装置有关的压力测量值的数据记录器的实施方式的示意图；
图15是示出了图14的数据记录器的元件的实施方式的框图；
图16是用于记录与图1A的食物摄入限制装置有关的压力测量值的数据记录系统的实施方式的示意图；
图17是示出了图16的数据记录系统的元件的实施方式的框图。
具体实施方式
现在将描述一些示例性实施方式以提供对本文中公开的装置和方法的结构、功能、制造以及用途的原理的全面理解。这些实施方式的一个或多个例子在附图中示出。本领域技术人员将会理解，在本文中具体描述并在附图中示出的装置和方法都是非限制性的示例性实施方式，本发明的范围仅仅由权利要求书来限定。结合一种示例性实施方式示出或描述的特征可与其他实施方式的特征组合。这种修改和变化也都包含在本发明的范围内。
本发明总的提供了用于收集与可植入的限制装置有关的阻抗数据的装置和方法。一般而言，所述装置和方法能够使患者、健康护理员和其他人员能够使用收集到的数据作为反馈机制，以便非侵入式地监控患者体内的可植入的限制装置的效力以及确定、修改和/或出具考虑了收集到的数据的治疗计划。这样的数据也可以用于为患者提供有关体重减轻进展方面的咨询和激励，例如通过确定体重减轻的拐点。能够收集并分析限制装置附近的组织(例如胃束带和患者胃之间的脂肪垫)的阻抗数据。因为组织是导电的，并且因为限制装置所用的材料(例如硅树脂)通常是不导电的，所以电流可以沿着组织行进。与组织接触的电极因而可以测量组织的阻抗，电极之间的阻抗随着组织的尺寸减少而变化(例如因为阻抗随着脂肪细胞收缩而减少)和/或随着组织在结构上的变化而变化。另外，因为这样的阻抗数据可以指示组织尺寸，阻抗渐进地收敛于指示最小组织尺寸的终值，所以阻抗数据可被用于前景分析，例如用于使脂肪垫的尺寸与重量减轻轮廓线的走势(profile)、重量减轻速度和/或其他因素相关联。
虽然本发明可以与现有技术中已知的各种限制系统一起使用，但是图1A示出了在患者体内使用的食物摄入限制系统10的一种示例性的实施方式。如图所示，限制系统10一般包括可植入部分10a和外部部分10b。图1B示出了位于患者体外的可植入部分10a。如图所示，可植入部分10a包括被构造成围绕患者的胃40的上部定位的可调节胃束带20以及例如经过导管50与可调节胃束带20流体连接的注射端口30。注射端口30适于允许流体被引入到胃束带20中以及从胃束带20中除去，从而调节胃束带20的尺寸并由此调节施加到胃40上的压力。注射端口30可被植入到体内可通过组织接触的位置中。典型地，注射端口被定位在患者腹部的皮肤和脂肪组织层下的横向肋下的区域中。医生还典型地将注射端口植入到患者胸骨上。
在患者体内可以植入感测或检测装置，以与围绕或部分地围绕包含在可植入部分10a中的一个或多个元件的组织接触。在一种实施方式中，测量装置是被构造成与组织接触并且测量组织阻抗的阻抗测量装置。虽然阻抗感测装置可以具有各种结构并且被定位在患者体内的任何部位(包括定位在注射端口30内)，但是在所示实施方式中，阻抗感测装置是位于传感器外壳60内的阻抗测量装置形式并且与一个或多个传感器电极(有线或无线)电连通。传感器电极也可以具有各种结构、任意数目以及被设置成与任意组织(例如脂肪组织、器官等)接触，但是在该实施方式中，两个阻抗感测电极被设置在束带20的组织接触面(例如外表面)上。感测电极能够驻留在组织表面上和/或穿透进入组织。通过增加离散测量点的数量，传感器电极的周向阵列可以提供更高的分辨率，由此增加周围组织的累积测量阻抗的准确性和精确性。
在可植入部分10a中还可包括与封闭的流路流体连通的感测或测量装置。在一种实施方式中，感测装置是被构造成测量封闭流路的流体压力的压力感测装置。虽然压力感测装置可具有各种构造并可被定位在沿着内部部分10a的任何地方，包括定位在注射端口30中，但是在图示的实施方式中压力测量装置为压力传感器的形式，该压力传感器被设置在与注射端口30相邻定位的传感器外壳60中。导管50可包括联接在胃束带20与传感器外壳60之间的第一部分和联接在传感器外壳60与注射端口30之间的第二部分。
除了此处描述的感测内部部分10a中的流体压力之外，食管和/或胃40中的流体压力还可使用任何合适的装置感测，诸如使用内窥镜压力计。作为非限制性的例子，这样的流体压力测量值可与在调节内部部分10a中的压力之前、过程中和/或之后的该内部部分10a内的流体压力测量值进行比较。本领域技术人员可理解食管和/或胃40中的测量压力的其他合适用途。
虽然理解了感测装置一般可被构造成获得与一个或多个相关参数有关的数据，但是感测装置于此被描述为阻抗感测装置和压力感测装置。
如同在图1A中进一步显示的那样，外部部分10b一般包括数据读取装置70，该数据读取装置70被构造成定位在诸如束带20、传感器外壳60、注射端口外壳30等的可植入元件(其可植入厚的组织下面，例如超过10cm厚)上方的皮肤表面上，以便以非侵入方式与所述元件通信并由此获得数据。数据读取装置70可任选地与控制箱90(以无线方式或者有线方式，如在该实施方式中经过电缆组件80)电联接，该控制箱90可显示诸如压力测量值、阻抗测量值和/或从数据读取装置70获得的其他数据。虽然在该例子中控制箱90显示为相对于患者处于本地，但控制箱90可相对于患者处于本地或者远程位置处，如下面将更详细说明的。
图2A更详细地显示了胃束带20。虽然胃束带20可具有各种构造，并且本领域目前已知的各种胃束带都可被用于本发明，但是在图示的实施方式中胃束带20具有大致细长的形状，并带有具有第一端部20a和第二端部20b的支撑结构22，该支撑结构22可形成为一个环，使所述第一和第二端部彼此连接。各种配合技术可被用于将端部20a、20b彼此连接起来。在图示的实施方式中，端部20a、20b为配合在一起的带子的形式，并且一个叠置于另一个顶部上。在图示的另一种实施方式中，例如在图1B和2B中，在胃束带20一端上的支撑结构可包括开口，胃束带20的另一个端部可穿过该开口，从而将两个端部彼此连接。胃束带20还可包括可变容积元件，诸如可膨胀囊24，该囊设置在支撑结构22一侧上或在支撑结构22一侧上形成，并被构造成与组织邻近定位。囊24可相对于胃的外壁膨胀或者收缩，从而形成可调节的人造口，以便可控制地限制食物摄入到胃中。
本领域技术人员将会理解，胃束带可具有各种其他构造。此外，在本文中公开的各种方法和装置都可等同应用于其他类型的可植入束带。例如，束带可被用于治疗大便失禁，如同在美国专利No.6461292中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗小便失禁，如同在美国专利公开No.2003/0105385中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗胃灼热和/或返酸，如同在美国专利No.6470892中公开的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗阳痿，如同在美国专利公开No.2003/0114729中描述的那样，该文献的内容通过引用而包含在本申请中。
图2B显示了围绕患者的胃食管结合部应用的可调节胃束带20。如图所示，胃束带20至少大体上围绕胃40的靠近与患者食管42的结合部的上部。在优选以胃束带20中含有少量或者不含流体的紧缩构将胃束带20植入后，胃束带20可例如使用生理盐水被膨胀，以缩小人造口开口的尺寸。本领域技术人员将会理解，包括机械技术和电技术的多种技术都可被用于调节胃束带20。
流体注射端口30也可具有各种构造。在图3中显示的实施方式中，注射端口30具有大致圆柱形外壳，该圆柱形外壳具有远侧面或底面以及从底面向近侧延伸并限定了近侧开口32的周壁。近例开口32可包括延伸穿过该开口并提供了在外壳中形成的流体容器(在图3中不可见)的入口的针穿刺隔膜34。隔膜34优选设置在足够靠近的位置，使容器的深度足以暴露于针(诸如休伯针)的开口尖端，使得流体输送可发生。隔膜34优选被设置成使其在被针穿刺并且针退出后自密封。如图3中进一步显示的那样，注射端口30可还包括导管连接件36，该导管连接件36与容器流体连通并被构造成与导管(例如导管50)联接。本领域技术人员将会理解，外壳可由任意数目的材料制成，包括不锈钢、钛或者聚合物材料，并且隔膜34同样可由任意数目的材料制成，包括硅树脂。
读取装置70也可具有各种构造，一种示例性的压力读取装置在共同拥有的美国专利公开No.2006/0189888和No.2006/0199997中更详细地公开，该文献的内容通过引用而包含于本申请中。一般说来，读取装置70可以非侵入方式测量被植入部分10a中的流体压力，即便在压力感测装置被植入到厚(至少超过10cm)的皮下脂肪组织之下时也是如此。医生可依靠传感器外壳60的位置、其他压力感测装置的位置和/或其他数据收集装置(诸如下面详细描述的阻抗系统)的位置附近的患者皮肤保持读取装置70，并观察显示在控制箱90上的压力读数。数据读取装置70还可以使用带子、粘合剂和其他公知方法可拆卸地连接到患者(将在下面进一步讨论)，诸如在延长的检查过程中。数据读取装置70可通过传统的布质或纸质手术单操作，并且还可以包括对于每个患者可更换的一次性的罩(未显示)。
如上所述，系统10还可包括压力测量装置，该压力测量装置与封闭流路连通并且被构造成测量与由可调节的胃束带20施加在患者的胃40上的限制量对应的压力(例如流体压力)。对压力进行测量可使得能够对由束带调节产生的限制的效力和功能进行评估。如图4中所示，在图示的实施方式中，压力测量装置为设置在传感器外壳60中的压力传感器62的形式。但是，压力测量装置可设置在可植入部分的封闭液压回路中的任何地方，并且各种示例性位置和构造在共同拥有的美国专利公开2006/0211913中更详细地公开，该文献于2006年3月7日提交、题为“Non Invasive Pressure MeasurementIn a Fluid Adjustable Restrictive Device”，该文献通过引用而包含在本申请中。
一般说来，所示的传感器外壳60包括与可植入部分10a中的流体流体连通的进口60a和出口60b。已经植入的导管50可被改造成与传感器外壳60一起使用，诸如通过切割导管50并将带倒刺的连接器(或者任何其他连接器，诸如夹钳、夹片、粘合剂、焊接等)插入到导管50的被切割的端部。传感器62可设置在外壳60内并被构造成响应于液压回路中的流体压力变化并将压力变化转化成数据的可使用形式。如下面进一步所述，压力感测系统还可以包括微控制器(例如处理器)、经皮能量传输(TET)/遥感线圈、以及电容器。任选地，压力感测系统还可以包括温度传感器。微控制器、TET/遥感线圈以及电容器可经过电路板或任何其他适当的元件连通。应当理解，TET/遥感线圈和电容器能够一起形成调谐振荡电路，用于接收来自外部部分10b的功率并且将数据传输至读取装置70。而且，在遥感元件在没有辅助的情况下不能接近位于患者体外的遥感装置时，可以通过任何适当数目的继电器(未示出)或其他装置提供这样的辅助。
本领域已知的各种压力传感器均可被用作压力传感器62，例如由美国乔治亚州亚特兰大的CardioMEMS公司提供的无线压力传感器，但合适的微机械(MEMS)压力传感器也可得自任何其他来源，包括但不限于：美国密歇根州伊普西兰蒂的Integrated SensingSystems公司(ISSYS)和美国马萨诸塞州沃尔瑟姆的Remon MedicalTechnologies公司。一种示例性的MEMS压力传感器在美国专利No.6855115中描述，该文献的内容通过引用而包含在本申请中，仅用于说明的目的。本领域技术人员还能理解，合适的压力传感器可包括但不限于电容传感器、压敏电阻传感器、硅应变仪传感器或者超声(声学)压力传感器，以及能够测量压力的各种其他装置。
图5示出了包括在食物摄入限制系统10的内部部分10a和外部部分10b中的元件的一种实施方式。如图5中所示，外部部分10b包括用于将功率信号132传递到内部部分10a的初级TET线圈130。遥感线圈144也被包括用于将数据信号传递到内部部分10a。初级TET线圈130和遥感线圈144组合形成天线，例如读取装置70。例如设置在控制箱90中的外部部分10b包括用于控制应用到初级TET线圈130的功率的TET驱动电路134。TET驱动电路134由具有相关存储器138的微处理器136控制。图形用户界面140与微处理器136连接以便输入患者信息、显示数据和医生指令、和/或打印数据和医生指令。通过用户界面140，用户诸如患者或者临床医生可将调节请求传输给医生并且还可以输入请求的原因。另外，用户界面140可使患者能够读取并响应来自医生的指令和/或警报，如下面进一步所述。
外部部分10b还包括初级遥感收发器142，用于将询问指令传输到植入的微控制器65并从微控制器65接收响应数据(包括感测的阻抗数据和感测的压力数据)。初级收发器142与微处理器136电连接以便输入并接收指令和数据信号。初级收发器142驱动遥感线圈144，从而以选定的RF通信频率谐振。谐振电路可生成将指令数据传输到微控制器65的下行交变磁场146。作为替代，收发器142可接收来自内部部分10a中的次级TET/遥感线圈114传递的遥感信号。接收的数据的任何部分或全部可被存储在微处理器136的关联存储器138中。功率源150可为控制箱90提供能量以便为内部部分10a中的元件提供功率。环境压力传感器152与微处理器136连接。微处理器136可使用来自环境压力传感器152的信号以便对于大气压环境下的变化(例如由于气压条件或者高度的变化)调节接收的压力测量值，以便增加压力测量值的精确性。
图5还示出了包括元件的内部部分10a，在该实施方式中，除了如下所述第一和第二传感器电极72、74被设置在束带20上之外，所述元件被包括在传感器外壳60中。如图5中所示，次级TET/遥感线圈114接收来自外部天线的功率/通信信号132。次级线圈114形成调谐振荡电路，其与初级TET线圈130感应耦合，为植入物或者初级遥感线圈144提供功率以接收和发送数据。遥感收发器158控制与次级线圈114的数据交换。另外，内部部分10a包括整流器/功率调节器160、微控制器65、与微控制器65相关联的存储器162、温度传感器112、压力传感器62、传感器电极72、74和信号调节电路164。植入的元件可将数据(由于温度等而带有或不带有调节部分)从传感器62和/或电极72、74经天线(初级TET线圈130和遥感线圈144)传输到控制箱90。数据可被存储在存储器138中并被相对于环境压力进行调节、在控制箱90的显示器上显示和/或可能实时传递到患者的远程位置处的远程监测站。
图6示出了包括设置在胃束带20的组织接触表面上(例如与脂肪组织76接触)的传感器电极72、74的胃束带20的一种实施方式。一般而言，电极72、74可将测量数据(以有线或无线的方式)传送到阻抗测量装置，例如诸如微控制器65的处理器，该阻抗测量装置一般可以测量电极72、74之间的阻抗。微处理器65可将从电极72、74接收到的任何或所有数据储存在存储器162中，分析任何或所有数据，和/或经过读取装置70将任何或所有数据以遥感的方式发送至外部装置(例如控制箱90)。虽然在该所示的实施方式中电极72、74被设置在束带20的外侧表面上，但是电极72、74可被设置在植入的部分10a中的任何地方，可以被设置或者不被设置在束带20的表面上。例如，电极72、74可以被包括作为设置在体内的专用感测装置的组成部分以便接触组织。另外，在该实施方式中，电极72、74可接触脂肪组织76并收集与该脂肪组织76相关的数据，但是电极72、74可接触非脂肪组织(优选地，但不是必须地，在形成于患者体内的限制邻近的位置处)，并且与这样的组织相关的任何感测阻抗数据可按此处所述的方式处理。
电极72、74可由能够测量组织阻抗的任何材料制成。电极72、74可由适合在体内使用的生物相容性材料制成，诸如聚合物、生物相容性金属以及其他相似类型的材料。材料的非限制性例子包括铜、金、不锈钢、钛、银和铂-铱(Pl-Ir)。另外，电极72、74可具有任何尺寸和形状。电极72、74的例子包括广泛用于起搏器并且在商业上能够买到的电极。
涂层可被用于使电极72、74绝缘并且防水，以避免电极72、74的渗流和可能的短路。涂层可由适合于在体内使用并且不会与电极72、74的功能相干扰的任何生物相容性材料制成。作为非限制性的例子，合适的材料可包括聚氨酯、硅树脂、溶剂型聚合物溶液以及会附着在电极72、74上的任何其他聚合物。用于施加涂层的合适技术包括喷涂和浸涂。电极72、74可分开涂敷不同的涂层或在单次涂敷中一起涂层，并且可以在将电极72、74设置在束带20的表面上之前或之后对电极72、74进行涂敷。粘合剂或任何其他配合技术可被用于牢固地或可拆除地将电极72、74联接到束带20上。
在束带20上显示了两个电极72、74，但是任何数目的电极都可被设置在束带20上(和/或设置在植入部分10a中的其他位置)。如果束带20包括多于两个电极72、74，那么多个阻抗测量值可在不同电极之间测得，从电极72、74传送到微控制器65，通过微控制65进行分析，和/或从微控制器65传送到外部装置。
如图7所示，微控制器65能以初始的固定距离D线性地对齐。随着患者体重减轻，脂肪组织76的尺寸变小(因为脂肪组织76中的脂肪细胞收缩)，由此将电极72、74拉得更近(例如比初始距离D更短的距离D2，如图8所示)并且相应地改变电极72、74之间的阻抗。因此，初始的固定距离D在患者体重减轻时应该允许电极72、74保持分开一定距离(例如彼此不会接触)。但是，在一些实施方式中，电极72、74之间的距离可被调整就位，例如通过使电极72、74运动至束带20表面上的不同位置、通过将束带20替换成具有带不同间隔的电极72、74的束带、通过植入一个或多个附加电极等。通常而言，电极72、74之间的距离越大，电极电势就越强。在含有多于两个电极72、74的结构中，阻抗测量可以在不相邻的电极之间进行，由此允许在不对任何电极的位置进行物理上的调节的情况下改变距离D。替代地，通过测量电极72、74之间的谐振激励频率的变化，可以测量电极72、74之间的电容变化，如下面更详细所述。
在使用中，电极72、74可收集数据并将测量信号传输至微控制器65。电极72、74能以任何更新速率(例如大约20Hz)提供数据，如在该实施方式中那样。这样的速率能以大约每50ms完成遥感/TET模式循环。例如，TET/遥感线圈114可给传感器外壳60提供大约45ms的经皮能量传输以给传感器外壳60提供功率，并且随后提供大约5ms的数据遥感。当然，可以使用任何其他切换布置。例如，因为组织76的阻抗一般随着时间缓慢变化，所以可以以低速(例如每天一次)提供自动的阻抗数据遥感，甚至微控制器65可以更快或更慢的速率传输收集的其他数据。还应当理解，在TET和遥感之间的切换不是必须的。例如，传感器外壳60可以是有源的，从而不需要TET。作为另一种例子，次级线圈(未示出)可被加到传感器外壳60上，并且传感器外壳60中的其中一个线圈被专门用于TET，另一个线圈专门用于遥感。
电极72、74能以各种方式收集阻抗数据。可被用于测量组织阻抗的示例性的阻抗测量系统在共同所有的美国专利No.5817093中更具体地描述，该美国专利通过引用结合入本文。一般而言，组织76可通过电压激励源或电流激励源被激励，以在电极72、74周围和/或之间产生电场，并且阻抗可从结果电流和电压计算出来，其中|Z|＝Vrms/Irms。在该实施方式中，一个频率用于激励组织76(通常是在神经肌肉激励范围以外的频率)，但是可以使用若干频率，这可通过允许待收集的组织阻抗的频谱响应来增加阻抗测量值的精度。激励源可被包括在可植入部分10a中或者外部部分10b中(例如由控制箱90通过读取装置70提供)。在一些实施方式中，电极72、74可使用植入激励源和外部激励源两者激励，以例如允许电极72、74在被内部激励源激励时自动地收集数据并且在被外部激励源激励时根据请求收集数据。为了自动地收集数据，应当给电极72、74提供功率(例如从诸如包括在可植入部分10a中的电池或电容器的功率源)。图9示出了包括AC/DC电压源80的一种示例性电路78，该电压源80可被用于激励组织76并且允许在电极72、74之间测量电流。图10示出了包括电流源84的另一种示例性的电路80，电流源84可被用于激励组织76并且允许在电极72、74之间测量电压。本领域技术人员还应当理解其他替代和变型方式。
在已经接收到来自电极72、74的感测数据后，微控制器65可将数据的任何部分或者全部存储在存储器162中，任何类型的存储器可被用作存储器162，包括但不限于一个或多个易失存储器(例如静态随机存取存储器等)、非易失性存储器(例如闪存、硬驱等)、或其他存储器。另外，存储器162可被用于存储预选的信息或预选的信息类型。例如，存储器162可存储最大、最小和基线的测量值数据(例如阻抗、压力等)、压力测量值、患者体重、透视图像或患者吞咽视频、和/或适于存储在存储器162中的任何其他信息，如本领域技术人员将理解的那样。
根据微控制器65的编程，微控制器65能对从电极72、74接收到的数据以彼此结合或独立的方式进行分析。典型地，微控制器65分析在一段时间内测量的数据值序列，而不是分析每个离散的测量值，由此允许分析时间变化趋势并通过不必连续分析后续数据来节省处理资源。但是，微控制器65可评估离散数据测量值(和/或数据范围)以找出无效数据并且确定放弃无效数据。另外，微控制器65可将其接收到的所有感测数据存储在存储器162中并且随后以任何分析频率分析所述感测数据的任何部分，例如每“X”分钟、在对应于检测到压力变化的时刻、以及在收到来自外部装置的信号时分析存储的数据。微控制器65可存储从电极72、74接收到的所有测量值以将其传输到外部装置，但是仅仅计算测量值的采样阻抗。
分析阻抗数据可包括例如使用来自电极72、74的数据测量阻抗。通过从电极72、74接收到的测量值的一些或全部推断出阻抗，微控制器65可测量阻抗，例如在电极72、74将电压数据传输到微控制器65的情况下通过确定两个电极72、74之间的电压，微控制器65可测量阻抗。作为另一个例子，微控制器65可通过将在电极72、74之间测得的阻抗与阻抗值范围比较来分析数据，由此形成闭环反馈系统。微控制器65可确定是否每个阻抗读数都不同于通常指示标准阻抗或基线阻抗的阻抗阈值。被微控制器65用来与测量阻抗值进行比较的阻抗值范围和/或阻抗阈值通常由医生根据患者尤其是对于刚被植入束带的患者或典型患者的历史表现、根据在将束带20植入患者体内时或者之后不久获得的阻抗读数编程入微控制器65中。患者的阻抗值范围和阻抗阈值可随时间变化，例如当患者体重增加或减轻时，并且不同患者可具有不同的范围和阈值。如果阻抗读数大于等于阈值(或小于等于阈值，取决于阈值)，或者如果阻抗落在阻抗值范围以外，那么测量阻抗可以指示发生了对分析目的而言可能重大的事件，例如束带压力变化、组织结构变化、体重变化、束带滑移、组织侵蚀、电子误差等。
微控制器65还可确定任何数据是否启动警报或警示。数据能以各种方式启动警报，并且启动警报的一个或多个条件可被编程入微控制器65中。这样的条件可因患者而异并且对于特定患者可随时间变化，诸如患者的治疗计划变化或者当患者体重增加或减轻时。例如，如果微控制器65确定任何阻抗数据落在阻抗值范围以外和/或大于或小于阻抗阈值，那么微控制器65可给医生、患者和/或任何数量的其他人员提供警报，因为这样的偏离的阻抗值可指示患者体内的可能的内部问题或身体变化(例如体重增加或减轻)，这可以指示需要调整患者的治疗计划(例如，诸如改变束带20内的流体量的内部调节，或者诸如建议患者改变身体活动量或者改变患者的营养计划的外部调节)。作为另一种例子，微控制器65可确定在一段时间中测量的阻抗值基本不变，这通常指示电极72、74之间的组织量基本没有变化以及体重减轻停滞。启动警报以提供这种减轻停滞的通知，帮助医生确定对患者的治疗计划的任何适当改变(例如，诸如调节束带20的压力的内部调节，或诸如建议患者少吃点的外部调节)。
在另一种例子中，微控制器65可分析收集到的与患者体重相关数据(例如，脂肪组织76的阻抗、不同连续时间的患者体重、压力数据、以及与患者体重相关的这些或其他数据的任何组合)，以确定曲线的拐点。图11示出了指示患者的脂肪垫减少到其最小尺寸的这种曲线900的例子，其中患者体重的拐点发生在大约重量192和时间9处。(图11中仅仅以例子的方式示出了体重、时间和拐点。)曲线900中的拐点可指示脂肪组织76的最小化并且患者的治疗计划应当被调节(例如内部调节，诸如将束带20束紧以考虑减掉的脂肪)。在一些实施方式中，微控制器65可从一组数据值(例如患者体重，如图11所示)产生曲线900并且使用附加的一组或多组数据值(例如，诸如压力和阻抗的感测数据)来确证曲线900中的拐点。如果通过附加的一组或多组数据值确证了拐点，那么微控制器65可启动警报。
在又一种例子中，微控制器65可确定测量阻抗是否比以前测量的阻抗(通常是前一测量阻抗)有所增加。增加的阻抗通常对应于电极72、74之间的更大距离，因为电流行进通过在更长距离上的更多组织。阻抗的增加可由例如患者体重的增加(脂肪细胞尺寸增加)或者电极72、74之间的脂肪组织76的结构变化(由例如组织褶皱导致电极72、74之间的组织增加或食物团)引起。同样，减少的阻抗可由例如患者体重减轻或电极72、74之间的组织减少引起。图12示出了限制系统的另一种实施方式，显示出在一组电极1002和对置的一组电极1004之间的正常阻抗路径1000以及在电极1002、1004之间由于组织褶皱1008或食物团导致的改变的阻抗路径1006。再次参照前面描述的实施方式，因为脂肪组织76结构上的变化通常导致阻抗的突然增加，与之相反，阻抗的渐进式增加通常与体重的逐渐增加相关，微控制器65可被构造成检测阻抗的突然增加。组织结构的变化可使用微控制器65以非侵入的方式确证，例如通过分析一个或多个附加数据值(诸如由传感器62收集的压力数据)确证。如果传感器62检测到对应于阻抗突然增加的时刻的压力上升，那么微控制器65可得出脂肪组织76在结构上发生变化的结论并且相应地启动警报。
微控制器65可通过例如将指示相关数据并且启动警报通知的信号传送至外部装置(例如控制箱90)来提供警报。警报可包括以下任何一种或多种：电子邮件、电话呼叫、文字消息、声频信号、显示在外部装置上的消息或者任何其他类型的警报。在相同条件下两个或多个警报可以提供给若干人员，但是警报可以不同时提供给若干人员。警报的条件和/或警报的类型也可相对于警报的接收者变化。例如，就给医生的警报而言，这样的警报可限于在发生指示电极72、74失调的事件(例如在使束带20回复到正常的蠕动压力的尝试中，患者由于组织76的褶皱而无法通过吞咽食物团被纠正)时提供的警报。就给患者的警报而言，这样的警报可限于患者的活动，诸如在出现患者正在减轻或增加体重的指示时提供的警报。本领域技术人员可想到警报可被引导到医生、患者和/或其他人员的各种其他条件。本领域技术人员将理解用于检测警报启动的其他适当的过程以及提供警报的方式。
存储在存储器162中的数据可被传递到外部装置。在一些实施方式中，微控制器65(经遥感收发器158和次级线圈114)连续传递数据，并且仅仅当合适的接收装置诸如天线(初级TET线圈130和遥感线圈144)运动到与其足够接近时数据才被接收。在一些实施方式中，当外部装置(例如读取装置70)以遥感方式为传感器外壳60提供功率时，例如当外部装置运动到传感器外壳60附近时，从存储器162发送数据可被启动。外部装置可以是可运动的(例如可被摇动或者放置在传感器外壳60附近的棒或者手持单元)或者是固定的(例如床边箱、患者可运动到其附近的台式安装箱或者车载箱)。以遥感方式为传感器外壳60提供功率可节省内部部分10a中的功率，因为发送通信功率由外部部分10b提供。
外部装置可被构造成存储从传感器外壳60接收到的数据。外部装置可进一步被构造成将数据传递到其他外部装置诸如远离患者的位置处的基础单元。外部装置(典型地为控制箱90或者具有显示或者提供警报能力的其他装置)可检测内部部分10a是否传递表示警报的信号并适当地提供警报(例如显示报警通知，发送电子邮件信息等)。
如在图13中所示的过程的一种实施方式中所示，在使用中，传感器通常可以收集与由束带20形成的限制有关的数据并且微控制器65可以分析感测数据，以确定感测数据是否不同于基线数据或典型数据。微控制器65还可(例如通过读取装置70)给控制箱90提供指示变化的警报，控制箱90可例如通过显示该警报(例如使用用户界面140)将该警报提供给用户。数据变化的这种检测和通知可为患者、医生和/或任何其他用户提供有关束带20效力的评价，包括用于校正任何不期望的感测数据的可能解决方案，由此允许提高束带的功能性，以便在问题恶化或负面影响患者动力之前及时(可能实时地)注意到这些问题，和/或提供其他诊断或治疗优点。
虽然在图13中所示的过程是结合对阻抗的分析以及包括在图1A至8中的元件进行描述的，但是本领域技术人员应当理解，该过程可被修改成包括更多或更少的元件，被重新组织或不重新组织，并且可在系统10中执行或在具有其他相似元件的其他相似系统中执行。在该实施方式中，电极72、74测量脂肪组织76的阻抗，但是任何组织阻抗可如此处所述一样处理。在该实施方式中，微控制器65处理指示，但是可使用被构造成为系统处理指示的任何处理器(例如中央处理单元、微处理器、状态机、专用集成电路(ASIC)、模拟计算机、光或光子计算机、逻辑电路等)。另外，在该所示实施方式中，传感器62测量流体压力，但是与束带20相关的任何感测的压力数据可以此处所述的方式处理。
电极72、74可收集与组织76的阻抗有关的数据(步骤1100)。电场可围绕电极72、74施加，从而脂肪组织76的阻抗可使用电极72、74测量。电场可以任何方式施加，例如通过设置在传感器外壳60中(例如与微控制器65一样设置在同一电路板上)的激励源，该激励源可为电极72、74提供时变信号(例如交变电流)。电极72、74可将收集的数据传输到微控制器65(步骤1102)。在接收到感测数据时，微控制器65可如上所述存储数据(步骤1104)、分析数据(步骤1106)、以及在必要时启动警报(步骤1108)。
如上所述，压力历史记录(例如由传感器62收集的压力数据)、阻抗历史记录(例如由电极72、74收集的阻抗数据)、和/或其他数据可被上传到控制箱90(和/或位于患者本地或远程的其他单元)，以允许人员以物理方式评估和/或以电子方式评估患者的治疗和/或包括在内部部分10a中的元件在指定的时间段内的性能。图14示出了一种外部装置(数据记录器270)的实施方式，其可被用作外部存储机构以存储一段时间内的阻抗测量值、压力测量值和/或任何其他数据。数据记录器270可起到可拆卸地连接的读取装置70的功能，如上所述。在该例子中，数据记录器270包括可穿戴封装件，该封装件外置于患者穿戴的带子274上并定位在如下区域上方或该区域的通信范围内，在所述区域下方可与数据记录器270通信的元件被植入患者内体。替代地，数据记录器270可被穿戴在患者颈部周围(如装置270’所示)，诸如当注射端口30被植入患者的胸骨上并且端口30包括压力感测装置时。在另一种实施方式中，数据记录器270也被植入患者体内。
如图14所示，数据记录器270包括TET线圈285和遥感线圈272，TET线圈285和遥感线圈272可被患者穿在身上以邻接内部部分10a定位。TET线圈285可将功率提供给植入物，遥感线圈272可询问植入物并且可通过植入部分10a中的次级遥感线圈114接收数据信号(包括压力测量值和阻抗测量值)。在另一种实施方式中，TET线圈285和遥感线圈272可被结合成单个线圈并且以任何合适的持续时间在TET和遥感功能之间变换。
组织的阻抗可被重复测量、定期测量、在从微控制器65收到信号时测量、和/或以本领域技术人员理解的任何其他间隔来测量。阻抗测量值可同样以足以监控阻抗的任何更新速率被传输到数据记录器270。
胃束带20中的压力可被反复感测并以足以测量抵靠胃束带20的蠕动脉冲的更新速率传递到数据记录器270。典型地，该更新速率在每秒10-20个压力测量值的范围内，但任何更新速率范围均可被使用。数据记录器270通常在醒着的阶段内穿戴以记录在患者进食和日常生活过程中的压力变化。在一天结束时，或者在其他设定时间段结束时，数据记录器270可被除去并且记录的压力数据被下载到外部存储器138中。压力历史可在随后的通信期间经一个或多个通信连接装置从存储器138上传到远程单元。作为替代，压力数据可使用一个或多个通信连接装置直接从数据记录器270上传到远程单元。通信连接装置可包括任何单个数据传递媒体或者组合的两个或多个数据传递媒体，包括利用高速电缆或者拨号连接的基于网络的系统，公用电话线、无线RF网络、蓝牙、超宽带(UWB)、人造卫星、T1线或者适于在远程位置之间传递数据的任何其他类型的通信媒体。数据记录器270可被构造成对接到另一装置中，例如对接站，所述装置被构造成接收与数据记录器270的通信数据并将接收的数据传递到远程单元。
图15更详细显示了数据记录器270。如图15所示，数据记录器270包括用于控制与内部部分10a遥感通信的微处理器276。微处理器276与存储器280连接以便存储来自内部部分10a的压力测量值。在该实施方式中，存储器280包括40MB的静态随机存取存储器并被构造成存储100小时的带时间标记的压力数据，但存储的任何其他类型也可被使用，并且存储器280可存储任意量和任何类型的数据。作为非限制性的例子，任何其他类型的易失性存储器或者任何其他类型的非易失性存储器都可被使用，包括但不限于闪存存储器，硬驱存储器等。虽然在该例子中数据记录器270是可操作的，但数据可以由微处理器276控制的指定数据速度被读取并存储在存储器280中。
微处理器276可由功率源282提供能量。在一种实施方式中，功率源282包括充电电池(未显示)，诸如充电电池组。在一些实施方式中，充电电池可拆卸并可使用充电单元充电并在对用过的电池充电时以其他充电电池替换。在其他实施方式中，充电电池可通过将充电适配器插入到数据记录器270中和墙壁插座中而被充电。在还一种实施方式中，充电电池可通过无线充电单元无线充电。在又一种实施方式中，功率源282包括超电容器，其也可被充电。当然，任何其他类型的功率源都可被使用。
为了记录压力，微处理器276可最初经TET驱动电路283和TET线圈285将功率信号传递到内部部分10a。在传递功率信号之后，微处理器276可经遥感收发器284和遥感线圈272将询问信号传递到内部部分10a。询问信号可由遥感线圈114截取并传递到微控制器65。微控制器65可经收发器158和次级遥感线圈114发送来自传感器62的响应的数据信号(诸如来自电极72、74的阻抗读数)或任选温度调节的压力读数。数据信号可通过遥感线圈272被接收并由收发器284引导到微处理器276。微处理器276可存储数据并启动下一询问要求。如果可应用，微处理器276还可对由微控制器65识别的警报产生响应，诸如使用视觉警报(例如在数据记录器270上闪烁的灯，将信息显示在用户界面292上等)和/或听觉警报。用户界面292可包括任意数目和类型的元件，包括但不限于扬声器、发光二极管、液晶显示器、通/断开关等。在一些实施方式中，用户界面292被构造成仅仅将输出提供给患者并且不允许患者对数据记录器270进行输入。用户界面292因此包括当功率源282充分充电时点亮的发光二极管，和当功率源282需要被充电时点亮的另一个不同颜色的发光二极管，尽管这种功率指示器可使用任何类型和任意组合的指示器，诸如在低功率时发光的一盏灯、听觉警报，电子邮件警报等。在其他实施方式中，用户界面292可允许患者对数据记录器270进行输入并可相应地包括任何合适的元件和零件。
当结束测量和记录数据时，数据记录器270可从患者身上和/或从带子274上除去并且记录数据被下载到控制箱90(和/或任何其他外部装置)。数据记录器270可包括使用通信连接装置将数据直接传递到远程基本单元的调制解调器286。例如，患者可将调制解调器286与电话线(或者其他通信连接装置)连接，对医生的调制解调器拨号(如果需要的话)，并选择用户界面292上的“发送”按钮。一旦接通，微处理器276可通过电话线将存储的压力历史传递到包括在远程单元中的微处理器中。作为替代，数据记录器270可包括用于将记录器270与控制箱90连接的USB端口290。记录器USB端口290可与包括在控制箱90上的USB端口连接并且“发送”开关被启动以将数据下载到控制箱90中的存储器138中。在数据被下载之后，记录器270可通过用户界面292关闭或者重设并重新设置在患者和/或带子274上以便继续进行测量。
数据记录系统300的替代实施方式在图16中显示。在该例子中，数据记录系统300包括线圈头(coil head)354和数据记录器370。线圈头354和数据记录器370经可拆卸的电缆356连接。任何一个或多个合适的替代通信连接装置可被用于替代电缆356，包括但不限于无线发射机/接收机系统。在图示的实施方式中，线圈头354被穿戴在患者的脖子周围并通常定位在注射端口30上方并在传感器外壳60的通信范围内。数据记录器370佩戴在围绕患者腰部的带子274上。当然，这些相应的位置仅仅是示例性的，线圈头354或者数据记录器370或者它们两者可被定位在任何地方。作为非限制性的例子，当注射端口30被植入到患者腹部时，线圈头354可佩戴在带子274上。线圈头354和数据记录器370在图16中简单地表示为方框，仅仅用于说明的目的，线圈头354或者数据记录器370可以各种形状、尺寸和构造被提供。
数据记录系统300的示例性元件在图17中显示。如图所示，数据记录器370包括微处理器276，存储器280，功率源282，USB端口290以及用户界面292。线圈头354包括TET驱动电路283，遥感收发器284、TET线圈285和遥感线圈272。TET驱动电路283被构造成经电缆356从功率源282接收功率。TET驱动电路283进一步被构造成经电缆356从微处理器276接收信号。遥感收发器284被构造成经电缆356从微处理器276接收信号并将信号传递到微处理器276。在另一种实施方式中，遥感收发器284被构造成仅仅将信号传递到微处理器276。上述参照图15对所述元件的讨论也可被应用于图17中显示的元件。在图17中示出的实施方式中，线圈头354和数据记录器370可被视为将包括数据记录器270(见上述)的元件分成两个物理上分离的单元。本领域技术人员能够理解，图17中显示的任何元件以及它们的关系、功能等都可以任何合适的方式变化。
在本例子中，线圈头354被构造成与上面描述的天线(初级TET线圈130和遥感线圈144)类似并且以与其类似的方式起作用。线圈头354的TET线圈285被构造成为注射端口30提供功率。当然，如果被植入到患者体内的任何其他装置(例如泵等)被构造成从TET线圈285接收功率，TET线圈285也可为这样的装置提供功率。由TET线圈285提供的功率可通过TET驱动电路283提供到TET线圈285并由TET驱动电路283调节，该TET驱动电路283本身可经电缆356从功率源282接收功率。这种提供到TET驱动电路283的功率可经电缆356由微处理器276调节。另外或者作为替代，微处理器276可调节TET驱动电路283为TET线圈285提供功率的方式。虽然本例子设想了通过TET线圈285的RF发送信号的使用，但任何其他类型的提供功率的技术以及替代的功率通信都可被使用。本领域技术人员可想到这些元件之间的其他合适构造和关系以及它们可操作的替代方式。
线圈头354的遥感线圈272被构造成从线圈114接收信号，包括指示系统10中的阻抗(例如，脂肪组织的阻抗、胃组织的阻抗、食管组织的阻抗，等等)的信号、指示植入的胃束带系统中的压力(例如，注射端口30中的流体压力，导管50中的压力，和/或可调节胃束带20中的压力，使用压力传感器62获取的压力等)的信号、指示温度的信号、和/或表示来自任何其他源的任何其他类型信息的任何其他类型信号。遥感线圈272还可从任何其他任何来源接收表示任何其他类型的信息的任何其他类型的信号。由遥感线圈272接收的信号可被传递到遥感收发器284，遥感收发器284可经电缆356将所述信号传递到微处理器276。遥感收发器284可在将信号传递到微处理器276之前执行对从遥感线圈272接收的信号的翻译或者处理。其他合适的构造和这些元件之间的关系以及它们可操作的替代方式可由本领域技术人员理解。还应当理解，元件可被组合。作为非限制性的例子，TET线圈285和遥感线圈272可被结合成单个线圈并可以任何合适的速率在TET和遥感功能之间交替任何合适的持续时间。另外，虽然本例子设想了通过遥感线圈272的RF发送信号的使用，但应当理解，任何其他类型的通信技术(例如超声、磁等)以及与线圈不同的替代通信装置可被使用。
在一种示例性使用中，患者整个白天穿戴线圈头354和数据记录器370，以便将数据记录在存储器280中。在夜间，患者可将数据记录器370从线圈头354上拆下并将数据记录器370与对接站例如控制箱90联接在一起。在数据记录器370和控制箱90被联接时，控制箱90可将从数据记录器370接收的数据传递到远程单元。如果功率源282包括充电电池，在数据记录器370与控制箱90联接时，控制箱90可对电池充电。但是，患者不必为了将数据记录器370联接到控制箱90而将数据记录器370与线圈头354拆开。此外，除了在白天记录压力测量值之外，或者作为在白天记录压力测量值的替代，在夜间可将数据(诸如阻抗和压力测量值)记录在存储器280中，并且数据可在一天内24小时记录。在该方式中，测量值的获取和记录的定时不必仅仅被限制为白天的时间。
如上所述，数据记录器370可接收、存储并传递与限制系统中的阻抗和压力有关的数据。但是，数据记录器370可接收、存储和/或传递各种其他类型的数据。作为非限制性的例子，数据记录器370还可接收、处理、存储和/或传递有关温度、心电图(EKG)测量值、患者的进食频率、由患者进食的食物的尺寸、患者散步的量等数据。因此本领域技术人员能够理解，数据记录器370可被构造成处理接收到的数据以建立另外的数据以便传递到控制箱90。例如，数据记录器370可处理经线圈头354获取的阻抗数据以建立指示患者体重减轻的数据，以及可处理经线圈头354获取的压力数据以建立指示患者的进食频率的数据。本领域技术人员还能够理解，数据记录器370可包括另外的元件以获取非压力、非阻抗数据。例如，数据记录器370可包括计步器或加速计(未显示)以获取有关患者散步的量的数据。由所述另外的元件获取的数据可被存储在存储器280中并以与上述方式类似的方式传递到控制箱90。数据记录器370还可包括用于获得将与内部压力测量值一起作为因子被考虑(factored)的数据以说明各种条件对压力的影响的元件。例如，数据记录器370可包括用于测量大气压的气压计。在一些实施方式中，数据记录器370包括倾斜计或者类似装置以确定患者的朝向(例如站立、躺下等)的角度，其可被作为因子考虑进压力数据以说明由患者的朝向引起的静压力的影响。作为替代，用于获得非压力数据的倾斜计或者其他装置可与数据记录器370物理分离(例如被植入)。本领域技术人员可理解，还有其他类型的数据、所述数据可被获得的方式以及所述数据被使用的方式。
本领域技术人员还应当理解，这里描述的一种或多种实施方式可使健康护理员或者其他人使用阻抗数据和/或压力数据作为反馈机制，以识别患者、训练患者和/或出具患者的饮食建议。这样的反馈机制可提供数据或者以多种方式使用。例如，当患者吞咽特定食物部分时可获取压力反馈，并基于该压力反馈，患者可被建议或者教导吃更小的部分，更大的部分或者等于测试部分的部分。当然，如此规定的食物部分可通过当患者吞咽规定食物部分时评估获取的压力反馈来测试，使食物部分规定可通过复测法而被重新限定。作为另一个例子，脂肪组织的阻抗测量值可被用于在脂肪垫尺寸和一个或多个患者特性(诸如患者体重减轻轮廓线或体重减轻速度)相关联。作为再一个例子，患者可基于压力反馈与部分尺寸和/或基于任何其他参数测试适当的所需食物。本领域技术人员还能够理解，连续的阻抗数据和/或压力数据监测可在本地使用和/或远程使用，以使部分尺寸监测、食物一致性监测(例如液体-固体)、进食频率和/或其他患者活动能够进行。
本领域技术人员将会理解，本发明可应用于传统内窥镜和开放式外科器械中，以及应用于机器人辅助的外科手术中。
在本文中公开的装置可被设置成在单次使用后被处理，或者它们可被设计成多次使用。但是，在任一情况下，装置在至少一次使用后可被再生以便重新使用。再生可包括装置的拆卸、接着清洁或替换特定部件以及随后重新组装的步骤的任一组合。特别是，装置可被拆卸，并且装置的任意数目的特定部件或部分可选择性地以任何组合被替换或者除去。当清洗和/或替换特定部分时，装置可在再生工厂或者由手术团队在外科手术前立即被重新组装以便随后的使用。本领域技术人员将会理解，装置的再生可利用用于拆卸、清洗/替换以及重新组装的各种技术。所述技术的使用以及获取的再生装置都落入本发明的范围内。
优选地，在本文中公开的本发明将在外科手术前被处理。首先，获取新的或者使用过的器械并在需要的情况下对其进行清洁，该器械然后可被灭菌。在一种灭菌技术中，容器和器械被放置在闭合并密封的容器中，诸如塑料袋或高密度聚乙烯合成纸袋中。容器和器械然后被放置在可穿透容器的辐射场中，诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌的器械然后可被储存在灭菌容器中。密封的容器保持器械处于灭菌状态，直到其在医学场合下被打开。
优选的装置被灭菌。这可通过本领域已知的任何数目的方式来实现，包括β或γ射线、环氧乙烷、蒸汽。
在上述实施方式的基础上本领域技术人员将会理解本发明的进一步的特征和优选。因此，除非由权利要求书特别指明，本发明不由特别显示和描述的那些内容来限定。在本文中引证的所有出版物和参考文献通过全文引用而明确包含在本申请中。

Claims (10)

1.一种用于在患者体内形成限制的限制系统，包括：
可植入的限制装置，其用于在患者体内形成限制；
至少两个传感器电极，其设置在所述可植入的限制装置的组织接触表面上；以及
阻抗测量装置，其与所述传感器电极电子通信并且用于测量所述传感器电极之间的阻抗。
2.根据权利要求1所述的系统，其中，所述可植入的限制装置包括可调节的胃束带。
3.根据权利要求1所述的系统，还包括处理器，该处理器用于将在所述传感器电极之间测量的阻抗与阻抗值范围进行比较。
4.根据权利要求1所述的系统，其中，所述传感器电极被构造成与由所述可植入的限制装置形成的限制附近的组织接触，并且所述阻抗测量装置用于测量所述组织的阻抗。
5.根据权利要求1所述的系统，还包括处理器，该处理器用于在所述阻抗测量装置测量到所述传感器电极之间的阻抗不同于阻抗阈值时发出校正动作的信号。
6.根据权利要求5所述的系统，其中，所述阻抗阈值反映接近由所述可植入的限制装置形成的限制的组织的基线量。
7.根据权利要求5所述的系统，其中，在所述传感器电极之间测量的不同于阻抗阈值的阻抗值指示患者体重减轻或患者体重增加。
8.根据权利要求5所述的系统，其中，所述处理器被用于确定在一段时间内收集的测量阻抗值是否都处于指示体重减轻停滞的基本定值，如果是这样的话就发出报警信号。
9.根据权利要求5所述的系统，其中，所述校正动作包括建议改变所述可植入的限制装置内的压力。
10.根据权利要求5所述的系统，其中，所述校正动作包括建议修改患者的治疗计划。
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