CN101536939A - 胃限制装置数据处理装置和方法 - Google Patents

胃限制装置数据处理装置和方法 Download PDF

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CN101536939A
CN101536939A CN200910003261A CN200910003261A CN101536939A CN 101536939 A CN101536939 A CN 101536939A CN 200910003261 A CN200910003261 A CN 200910003261A CN 200910003261 A CN200910003261 A CN 200910003261A CN 101536939 A CN101536939 A CN 101536939A
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pressure
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M·S·奥尔蒂茨
D·N·普莱西亚
D·F·小德卢戈斯
D·C·耶茨
K·多尔
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7232—Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period

Abstract

本发明提供了用于处理可植入限制系统中的数据的装置和方法，更具体地提供了胃限制装置数据处理装置和方法。一般说来，该装置和方法允许收集、分析、存储和传递压力测量值。压力测量值数据在被存储之前可被压缩。另外，不是所有的压力数据都需要被记录或保留，诸如基本上等于可植入限制装置的静息或者标称压力、指示很少或没有压力变化的数据和指示孤立的非重现事件的数据。被记录的任何压力测量值数据可使用由外部装置以遥感方式提供的功率而传递到外部装置。

Description

胃限制装置数据处理装置和方法
技术领域
本发明涉及用于处理有关可植入限制装置的数据的方法和装置。
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胃束带的过大的接触面压力而导致胃组织的侵蚀时才被揭示。
另外，有利地是能够采集表示压力调节之前、过程中和/或之后胃束带中的压力的数据，用于调节、诊断、监测或者其他目的。还有利地是存储所述压力数据和/或将所述压力数据传递到外部。但是，数据存储空间可能受到限制，并且用于传递数据的功率可以是资源密集型(resource intensive)的。
因此，提供了用于胃限制装置的方法和装置，特别是用于处理收集的关于胃限制装置的数据。
发明内容
本发明总体提供了用于处理有关可植入的限制装置的数据的装置和方法。在一种实施方式中，提供了用于在患者体内形成限制的限制系统，该限制系统包括可在患者体内形成限制的可植入限制装置和与可植入限制装置相通信的可植入感测装置。可植入感测装置可感测有关可植入限制装置的参数并将考虑到数据相对于有关可植入限制装置的标称参数值的变化的数据的所选部分传递到外部装置。所述参数可包括例如脉冲计数、脉冲宽度和振幅中的至少一种。在一些实施方式中，数据的所选部分在被传递到外部装置之前被压缩。
感测装置可以各种方式实施。例如，当外部装置以遥感方式将至少一些功率提供给感测装置时，感测装置可将数据传递到外部装置。作为另一个例子，感测装置可放弃(discard)基本上等于标称值的数据。作为再一个例子，感测装置可基于数据是否包括处于限定范围内的值来传递数据的所选部分。作为又一个例子，感测装置将数据与标称值进行比较。对于还一个例子，感测装置可在将数据的所选部分传递到外部装置之前存储数据的所选部分。
在另一种实施方式中，一种用于在患者体内形成限制的限制系统包括：可在患者体内形成限制的可植入限制装置；与可植入限制装置相通信的可植入的压力感测装置，该可植入的压力感测装置可感测可植入限制装置中的压力；以及可确定在将任何感测的压力数据传递到外部读取装置之前是否存储任何感测的压力数据的处理器(其可被包括在可植入压力感测装置中)。在一些实施方式中，处理器可在外部读取装置被运动靠近可植入压力感测装置时被启动，将存储的数据下载到外部读取装置。在一些实施方式中，系统还可包括外部存储机构，其可存储感测的压力数据，将存储的压力数据传递到外部装置，并任选地可拆卸地连接到患者身上。
在其他方面，提供了一种在患者体内形成限制的方法。该方法包括如下步骤：使用可植入压力感测装置获取有关可在患者体内形成限制的可植入限制装置中的压力的数据；将所获取的压力数据的至少一部分存储在可植入压力感测装置中；并且在外部装置被运动到可植入压力感测装置附近时启动所存储的压力数据的传送。存储在可植入压力感测装置中的获取的压力数据可包括超过可植入限制装置中的标称压力的压力值。在一些实施方式中，该方法还可包括在将所获取的压力数据的至少一部分存储在可植入压力感测装置中之前压缩所获取的压力数据的至少一部分。压缩可使用至少一种压缩技术进行，诸如存储差分值、使用量化表、使用游程码以及使用赫夫曼编码压缩。
在另一种实施方式中，一种在患者体内形成限制的方法包括获取有关可在患者体内形成限制的可植入限制装置中的压力的压力数据。在一些实施方式中，获取压力数据包括在确定时间段降低压力数据收集率。该方法进一步包括在将压力数据传递到外部读取装置之前确定压力数据要保留的一部分。确定压力数据要保留的一部分可包括：确定获取的任何压力数据是否包括限定压力值范围内的值；确定保留超过可植入限制装置中的标称压力的任何获取的压力数据；和/或使用与可植入限制装置连接并被构造成获取压力数据的压力感测装置(例如处理器)处理获取的压力数据。如果任何获取的压力数据包括了超过压力值阈值的值，则用于与外部读取装置通信的警报可被生成。在一些实施方式中，该方法还包括在将压力数据传递到外部读取装置之前仅仅存储压力数据的被确定保留的部分。
在又一种实施方式中，一种在患者体内形成限制的方法包括：使用可植入压力感测装置获取有关可在患者体内形成限制的可植入限制装置中的压力的压力数据；将获取的压力数据存储在可植入压力感测装置中；并在存储获取的压力数据之前压缩获取的压力数据。获取的压力数据可使用至少一种压缩技术进行压缩，诸如存储差分值、使用量化表、使用游程码以及使用赫夫曼编码进行压缩。该方法还可包括将来自压力感测装置的压缩和存储的压力数据的至少一部分传递到外部装置。
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系统，包括：
能够在患者体内形成限制的可植入的限制装置；和
与所述可植入限制装置通信的可植入的感测装置，该感测装置被构造成感测有关所述可植入的限制装置的参数并将考虑到相对于有关所述可植入的限制装置的标称参数值的数据变化的数据的所选部分传递到外部装置。
(2)、如第(1)项所述的系统，其中，所述参数包括压力、脉冲计数、脉冲宽度和幅值中的至少一种。
(3)、如第(1)项所述的系统，其中，所述感测装置还被构造成，当所述外部装置以遥感方式将至少一些功率提供给所述感测装置时，所述感测装置将数据传递到所述外部装置。
(4)、如第(1)项所述的系统，其中，所述感测装置被构造成放弃基本上等于标称值的数据。
(5)、如第(1)项所述的系统，其中，所述感测装置被构造成根据所述数据是否包括处于限定范围内的值而传递所述数据的所选部分。
(6)、如第(1)项所述的系统，其中，所述感测装置被构造成将数据与标称值进行比较。
(7)、如第(1)项所述的系统，其中，所述感测装置被构造成在将所述数据的所选部分传递到所述外部装置之前存储所述数据的所选部分。
(8)、如第(1)项所述的系统，其中，所述数据的所选部分在被传递到所述外部装置之前被压缩。
(9)、一种用于在患者体内形成限制的限制系统，包括：
能够在患者体内形成限制的可植入的限制装置；
与所述可植入限制装置通信的可植入的压力感测装置，该压力感测装置被构造成感测所述可植入的限制装置中的压力；以及
能够在任何感测的压力数据被传递到外部读取装置之前确定是否存储任何感测的压力数据的处理器。
(10)、如第(9)项所述的系统，还包括被构造成存储感测的压力数据并将存储的压力数据传递到外部装置的外部存储机构。
(11)、如第(10)项所述的系统，其中，所述外部存储机构还被构造成可拆卸地连接到患者。
(12)、如第(9)项所述的系统，其中，所述处理器被构造成，当所述外部读取装置运动靠近所述可植入的压力感测装置时所述处理器启动将存储的数据下载到所述外部读取装置。
(13)、如第(9)项所述的系统，其中，所述可植入的压力感测装置包括处理器。
(14)、一种在患者体内形成限制的方法，包括：
使用可植入压力感测装置获取有关能够在患者体内形成限制的可植入限制装置中的压力的数据；
将获取的数据的至少一部分存储在所述可植入压力感测装置中；并且
当外部装置运动到所述可植入压力感测装置附近时启动存储的压力数据的下载。
(15)、如第(14)项所述的方法，还包括在将所获取的压力数据的至少一部分存储在所述可植入压力感测装置中之前压缩所获取的压力数据的至少一部分。
(16)、如第(15)项所述的方法，其中，所述压缩包括使用选自下组的至少一种压缩技术进行：存储差值、存储值、使用量化表、使用游程码以及使用赫夫曼编码。
(17)、如第(14)项所述的方法，其中，所述存储在所述可植入压力感测装置中的获取的压力数据包括超过所述可植入限制装置内的标称压力的压力值。
(18)、一种在患者体内形成限制的方法，包括：
获取有关能够在患者体内形成限制的可植入限制装置中的压力的压力数据；和
在将压力数据传递到外部读取装置之前确定压力数据要保留的部分。
(19)、如第(18)项所述的方法，其中，确定压力数据要保留的部分包括确定任何获取的压力数据是否包括处于压力值限定范围内的值。
(20)、如第(18)项所述的方法，其中，所述确定压力数据要保留的部分包括确定保留超过所述可植入限制装置中的标称压力的任何获取的压力数据。
(21)、如第(20)项所述的方法，还包括如果任何获取的压力数据包括超过压力值阈值的值，则生成用于传递到所述外部读取装置的警报。
(22)、如第(18)项所述的方法，还包括在将压力数据传递到所述外部读取装置之前仅仅存储被确定保留的压力数据部分。
(23)、如第(22)项所述的方法，还包括在将确定被保留的压力数据部分存储之前压缩确定被保留的压力数据部分。
(24)、如第(18)项所述的方法，其中，获取压力数据包括在确定时间段内降低压力数据的收集速率。
(25)、如第(18)项所述的方法，其中，确定要保留的压力数据部分包括使用与所述可植入限制装置连接并被构造成获取压力数据的压力感测装置处理获取的压力数据。
(26)、如第(25)项所述的方法，其中，处理获取的压力数据包括使用与压力感测装置电子通信的处理器。
(27)、一种在患者体内形成限制的方法，包括：
使用可植入压力感测装置获取有关能够在患者体内形成限制的可植入限制装置中的压力的压力数据；
将获取的压力数据存储在所述可植入压力感测装置中；并且
在存储获取的压力数据之前压缩获取的压力数据。
(28)、如第(27)项所述的方法，其中，压缩包括使用选自下组的至少一种压缩技术进行：存储差值、存储值、使用量化表、使用游程码以及使用赫夫曼编码。
(29)、如第(27)项所述的方法，还可包括将来自所述压力感测装置的至少一部分压缩和存储的压力数据传递到外部装置。
附图说明
通过下结合附图的详细描述，本发明将会被更全面的理解，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是围绕患者的胃食管结合部应用的图2A的食物摄入限制装置的示意图；
图3是图1A的注射端口外壳的一种实施方式的透视图；
图4是图1A的传感器外壳的一种实施方式的透视图；
图5示出了图1A的传感器外壳的一种实施方式；
图6是用于图5的压力传感器的变阻电路的实施方式的示意图；
图7是显示图1A的食物摄入限制装置的内部和外部元件的实施方式的框图；
图8是显示出用于图1A的食物摄入限制装置的数据处理方案的实施方式的流程图；
图9是来自图5的压力传感器的压力测量值的图形；
图10是来自图5的压力传感器的另一压力测量值的图形；
图11是用于记录有关图1A的食物摄入限制装置的压力测量值的数据记录器的实施方式的示意图；
图12是显示出图11的数据记录器的元件的实施方式的框图；
图13是用于记录有关图1A的食物摄入限制装置的压力测量值的数据记录系统的实施方式的示意图；
图14是显示图13的数据记录系统的元件的实施方式的框图；
图15是带有沿着导管定位的压力传感器的胃束带系统的实施方式的透视图；
图16是带有沿着导管定位的压力传感器的胃束带系统的实施方式的示意图；
图17是带有沿着导管定位的压力传感器的胃束带系统的另一实施方式的透视图；
图18是带有“T”形压力传感器和导管构型的胃束带系统的实施方式的示意图。
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。
本发明总体上提供了用于处理有关可植入限制装置的数据的装置和方法。一般说来，该装置和方法允许收集、分析、存储和传递涉及有关可植入限制装置的任何参数诸如压力、脉冲计数、脉冲宽度和振幅的测量值。虽然在这里讨论的方法和装置可涉及任何被感测的数据参数，在示例性实施方式中，测量值涉及压力。压力测量值可帮助精确地评估可植入限制装置的性能并确定任何可取的压力调节，但并不是所有的收集的压力数据在进行这种评估和确定时都是有帮助的。此外，处理压力测量值数据可耗尽可植入限制系统的功率源并可使用成本高昂、物理体积大并且电子学方面大的数据存储空间。压力测量值数据可在其被存储之前被压缩，从而使用比用于相应的未压缩数据的存储空间小的存储空间、时间、功率和/或带宽，以便进行通信。压力测量值数据还可在通信之前被压缩。数据可被压缩并直接传递，或者当询问时存储在存储器中的被压缩数据可被检索并无线通信。另外，不是所有的压力数据都需要被记录或者保持。不记录或者保持所有的压力数据(诸如基本上等于可植入限制装置的静息或者标称压力、指示没有或很小压力变化的数据和指示孤立的非再现事件的数据)可节省存储空间用于可能有更多分析价值的压力测量值数据并减少了用于压力测量值的物理存储空间和/或电子存储空间的大小。被记录的任何压力测量值数据可使用以遥感方式提供的功率或者与外部装置感应耦合的功率传递到外部装置，从而减少或者消除了被记录数据的存储位置本地的功率源。
虽然本发明可被用于本领域已知的各种限制系统，但是图1A示出了在患者体内使用的食物摄入限制系统10的一种示例性实施方式。如图所示，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和例如经过导管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。
内部部分10a还可包括与可植入部分10a中的封闭流路流体连通的感测或测量装置。在一种实施方式中，感测装置为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，如在下面进一步描述的那样，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可包括连接在胃束带20与压力传感器外壳60之间的第一部分和连接在压力传感器外壳60与注射端口30之间的第二部分。虽然能够理解，感测装置可被构造成获得与一个或多个相关参数有关的数据，但是总体上其可在本文中被描述为压力感测装置。
除了感测在这里描述的内部部分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，所述流体压力测量可与在内部部分10a的压力调节之前、过程中和/或之后该内部部分10a中的测量的流体压力进行比较。本领域技术人员可理解用于食管和/或胃40中的所测量压力的其他合适用途。
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被构造成定位在传感器外壳60(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传感器外壳60通信并由此获得数据(例如压力测量值)。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可显示压力测量值，和/或得自数据读取装置70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，如在下面更详细说明的。
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，并带有具有相对的第一和第二端部20a、20b的支撑结构22，该支撑结构22可形成为一个环，使端部彼此连接。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。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，多种技术，包括机械技术和电技术，都可被用于调节胃束带20。图2B还示出了压力传感器41的替代位置，该压力传感器41设置在胃束带20的带扣43中。
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。近侧开口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还可具有各种构造，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，数据读取装置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的位置和/或其他压力感测装置的位置附近的患者皮肤保持读取装置70，并观察控制箱90上的显示器上的压力读数。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还可包括与封闭流路连通并被构造成测量与由可调节胃束带20施加到患者胃40上的限制大小对应的压力(例如流体压力)的压力测量装置。测量压力使人们(例如医生、护士、患者等)能够评估由胃束带调节形成的限制的效力和功能。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，图示的传感器外壳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可被改进用于传感器外壳60，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中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。
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。
具有设置在其中的传感器62的传感器外壳60的构造的一种实施方式在图5中显示。在该实施例中传感器外壳60包括母板，母板可用作气密容器以防止流体与设置在传感器外壳60中除讨论的用于传感器62的那些之外的任何元件接触。传感器外壳60可由适于在体内使用的任何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。此外，传感器外壳60可由任何一种或多种透明(如图5所示)、不透明、半透明和不透射线的材料制成。除其他元件以外还包括微控制器65(例如处理器)的电路板64还可设置在外壳60中，以帮助处理并传递由传感器62收集的压力测量值以及与胃束带20有关的其他可能数据。如同在下面进一步讨论的那样，电路板64还可包括经皮能量传递(TET)/遥感线圈和电容器。任选地，温度传感器可被集成到电路板64中。微控制器65、TET/遥感线圈、电容器和/或温度传感器可经电路板64或者经任何其他合适的元件通信。TET/遥感线圈和电容器可一起形成用于从外部部分10b接收功率并将压力测量值传递到压力读取装置例如读取装置70的调谐振荡电路。此外，如果没有一些辅助手段与压力传感器62相关联的遥感元件不能到达置于患者体外的遥感装置，所述辅助手段可通过任何合适数目的中继器(未显示)或其他装置来提供。
流体可通过定位在外壳表面(这里指其底面)上的任何位置的开口66进入传感器外壳60并与传感器62的压力感测表面68接触。传感器62典型地相对于母板密封，使进入开口66的流体不能渗透并影响压力感测表面68之外的传感器62的操作。当流体流进和流出开口66时，传感器62可测量与压力感测表面68接触的流体的压力。例如，压力感测表面68可包括具有可变形表面的隔膜，使得当流体流过开口66时，流体冲击隔膜的表面，引起所述表面机械位移。隔膜的机械位移可通过包括一对可变电阻、硅应变仪的可变电阻电路转化成电子信号。一个应变仪可与隔膜的中央部分连接以测量隔膜的位移，而匹配的第二应变仪可连接在隔膜的外边缘附近。应变仪可使用粘合剂与隔膜连接或者可融合(diffuse)到隔膜结构中。当胃束带20中的流体压力波动时，隔膜的表面可上下变形，从而在应变仪的中央部分中产生阻抗变化。
用于传感器62的可变电阻电路的一种实施方式在图6中显示。所述电路包括第一应变仪96和第二应变仪98，它们形成半补偿惠斯通电桥电路100的两个顶部电阻元件。当第一应变仪96反应于传感器的隔膜的机械位移时，第一应变仪96的变化阻抗改变了通过电桥电路100的顶部的电势。第二应变仪98与第一应变仪96匹配并使惠斯通电桥电路100隔热(athermalize)。第一差分放大器102和第二差分放大器104与电桥电路100连接以测量由于可变电阻应变仪96、98而引起的电桥电路100中电势的变化。特别是，第一差分放大器102测量通过整个电桥电路100的电压，而第二差分放大器104测量通过电桥电路100的应变仪一半的差分电压。对于通过电桥的固定电压而言，应变仪电压之间的差越大，压差越大。来自差分放大器102、104的输出信号可被应用于集成到电路板64中的微控制器65，并且微控制器65可将测量的压力数据传递到置于患者体外的装置。如果需要，也可使用全补偿惠斯通电桥电路以增加压力传感器62的灵敏性和精确性。在全补偿电桥电路中，四个应变仪而不是仅仅两个应变仪与隔膜的表面连接。
图7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7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。例如控制箱90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要求传递给医生并且还传递该要求的提出原因。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/或压力测量值警报，如在下面更详细说明的。
外部部分10b还包括初级遥感收发器142，用于将询问指令传递到植入的微控制器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递到微控制器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144传递的遥感信号。接收的数据可被存储在与微处理器136相关联的存储器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7还示出了内部部分10a的元件，在该实施方式中这些元件被包括在传感器外壳60中(例如在电路板64上)。如图7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提供功率以接收和传递数据。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和信号调节电路164。植入的元件可将压力测量值(由于温度等而带有或不带有调节部分)从传感器62经天线(初级TET线圈130和遥感线圈144)输送到控制箱90。压力测量值可被存储在存储器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。
如图8中显示的过程所示，传感器外壳60通常可感测胃束带20中的压力，本地存储感测的压力数据(例如存储在存储器162中)，并经读取装置70将感测的压力数据的至少一部分传递到外部装置诸如控制箱90。虽然压力传感器62可将所有其感测的数据传递到读取装置70，但仅仅将压力数据的所选部分(例如比总体感测压力数据少的部分)可使用较少的功率，要求传感器外壳60中较小的物理存储空间和/或电子存储空间，和/或降低成本。
虽然在图8中显示的过程参照图1A-7中包括的元件进行讨论，但本领域技术人员将会理解，该过程可被修改以包括更多或更少的元件，被重新组织或者不被重新组织，并可在系统10或者另一种具有其他类似元件的类似系统中执行。例如，在该实施方式中，微控制器65处理指令，但可使用被构造成处理用于系统的指令的任何处理器(例如中央处理单元、微处理器、数字信号处理单元、特定用途集成电路(ASIC)、状态机、模拟计算机、光学或者光子计算机、逻辑电路，等等)。此外，在该图示的实施方式中，传感器62测量流体压力，但任何有关胃束带20的感测压力数据都可如这里讨论的那样被处理。
在使用时，传感器外壳60可使用传感器62感测设置在胃束带20中的流体压力(步骤400)。传感器62可将测量信号传递到信号调节电路164，该信号调节电路164可在将测量的压力数据传递到微控制器65(步骤402)之前对信号进行放大。作为替代，在一些实施方式中，传感器62可将信号直接传递到微控制器65。在该实施方式中，压力传感器62以大约20Hz的更新速度提供压力数据。这样的更新速度可以大约每50ms完成一个遥感/TET模式循环。例如，TET/遥感线圈114可提供大约45ms的用于传感器外壳60的TET以便为传感器外壳60提供功率并然后提供大约5ms的压力数据的遥感。当然，任何其他切换拓扑学也可被使用。还应当理解，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，而不需要TET。作为另一个例子，次级线圈(未显示)可被加入到传感器外壳60中，并且传感器外壳60中的其中一个线圈专用于TET，另一个用于遥感。其他替代和变化对本领域普通技术人员来说是可以想到的。
在接收感测的压力数据之后，微控制器65可确定是否存储数据(步骤404)，例如存储在存储器162中(步骤412)。任何类型的存储器都可被用作存储器162，包括但不限于一个或多个易失性(例如静态随机存取存储器等)存储器、非易失性(例如闪存、硬驱等)存储器或者其他存储器。确定是否存储数据允许微控制器65分析数据并可在将数据存储之前放弃至少一部分数据，从而使用在存储器162中可利用的较少存储空间。但是，微控制器65可被构造成存储所有感测的压力数据(步骤412)并因此而不能做出这样的确定，而代之以评估任何数据是否启动警报(步骤406)(将在下面进一步讨论)。(在这种构造中，可能在功率方面更有效地存储来自压力传感器62的原始(未处理)数据并经外部读取装置处理原始数据。)此外，存储器162可被用于存储预先选定的信息或者预先选定的信息类型。例如，存储器162可存储最大、最小、和/或基线的压力测量值、压力分布图、压力趋势、患者吞咽的荧光图像或者视频，和/或任何其他信息。本领域技术人员可想到适于存储在存储器162中的其他信息。
微控制器65在确定是否存储数据时可以各种方式分析数据。典型地，微控制器65分析在一段时间内测量的压力数据值的序列而不是分析每个离散的压力测量值，从而允许分析经过一段时间的压力趋势并通过不需要必须连续分析进入的数据而节省处理资源。但是，微处理器65可评估单个压力数据测量值(和/或数据范围)以便确定无效数据并确定放弃任何无效数据。一般说来，在确定是否存储数据时，微处理器65考虑来自胃束带20中的标称压力或者静息压力的压力数据的变化。标称压力典型地由医生根据患者体内的历史胃束带性能或者特别是在典型患者体内新近植入的胃束带的性能而被编程到微控制器65中。如果测量的压力数据超过标称压力，则该数据表明系统10中的压力发生变化并因此可能包括对于分析、诊断和/或其他目的来说潜在的有用信息。如果压力数据基本上等于标称压力，则该数据可能不能指示用于分析目的的潜在的重大事件，例如由于患者活动(诸如进食或饮水)导致胃束带压力的变化。微控制器65可放弃任何这种大致标称数据。放弃数据可包括不存储数据或者存储数据的标识，例如存储特定数组(例如“888”、“999”、“000”等)或者一个或多个字母字符。数据的不同标识可被用于指示不同类型的数据测量值，例如大致标称数据，限定压力范围之外的数据等等。但是在一些实施方式中，微控制器65可甚至将标称压力数据存储到存储区162中(步骤412)以保持压力测量值的完整历史记录。此外，微控制器65可将其接收的所有感测的压力数据存储到存储器162中(步骤412)，并随后确定是否保留或者放弃该数据，例如存储所有数据并且每隔“X”分钟和/或在收到外部装置的信号时对该数据进行分析。
图9和10显示了微控制器65可从传感器62接收的压力数据的示例性序列。在图9和10的每一个中，图表显示了感测的压力数据-时间(在24小时的时间段内)图。图9的图表包括处于标称压力水平409的大致标称压力的四个时段407a、407b、407c和407d。在图表中显示的标称压力水平409仅仅作为例子；标称压力值可以是任意值或者值的范围。此外，用于患者的标称压力值可随着时间过去例如当患者体重减轻时而变化。微控制器65可将来自该24小时时间段的压力数据与标称压力409比较并确定从标称压力时段407a、407b、407c、407d放弃的数据(例如从不将该数据存储在存储器162中或者从存储器162中删除这些数据)并仅仅存储剩余的压力数据的选择部分(步骤412)。在一些情况下，微控制器65可确定放弃超过标称压力409的压力数据。例如，微控制器65可放弃除患者在白天进食的三餐中的两餐过程中获取的数据之外的压力数据，例如放弃在四个时段407a、407b、407c、407d期间测量的数据和早餐时段411过程中测量的数据并存储与午餐和晚餐时段413、415对应的剩余的选定压力数据(步骤412)。压力数据可根据一个或多个由微控制器65考虑的因素确定为与特定一餐有关，诸如考虑一天当中当传感器62测量数据时和高于标称水平409的压力值的持续时间的组合。
微控制器65还可确定放弃有关一个或多个生理事件的压力数据，如图10中所示。生理事件的非限制性的例子包括超常事件(supraevent)(例如咳嗽、呕吐、扭伤(wretching)等等)和正常事件(normal event)(心跳、呼吸、谈话等等)。生理事件可导致在幅值、持续时间、发生(例如一天中不期望的时间诸如午夜)和/或频率方面与建立的患者进食模式的预期水平显著不同的测量压力数据。微控制器65可通过分析这样的明显不同的数据来确定保留压力数据，诸如通过确定任何获取的压力数据是否包括高于预编程阈值的值，而该预编程阈值除了响应于生理事件外通常不被超过。微控制器65还可或者代之以确定任何获取的压力数据是否包括压力值的限定范围内的值。根据限定的范围(在一些实施方式中该限定的范围可由前一压力数据值或者由对应于一天的特定时间的压力值限定上限和/或下限)，微控制器65可确定放弃该范围内的数据(例如，如果该范围反映了由正常事件引起的预期频率和幅值的压力读数)或者保留该范围内的数据(例如如果该范围包括达到除生理事件外通常不被超过的阈值的任何正的压力值)。作为例子，图10中的图表包括指示超常生理事件的压力数据413、指示正常事件的压力数据415和胃束带实际压力数据417。微控制器65可使用一个或多个编程算法放弃超常生理事件数据413和正常事件数据415，如上所述。
微控制器65还可确定任何数据是否启动警报(步骤406)。如果微控制器65确定任何压力数据落在压力值的限定范围之外和/或大于或小于阈值，则微控制器65可向医生、患者和/或任意数目的其他人提供警报(步骤408)，因为这种偏离的(outlying)压力数据可指示可能问题，诸如胃束带泄露、胃束带过紧、反复出现的扭伤(wretching)、胃束带滑脱、侵蚀，等等。微控制器65可通过例如将信号传递到外部装置(例如控制箱90)提供警报，指示可能存在问题的感测的压力数据并启动警报的通知。警报可包括下列任何一种或多种：电子邮件、电话、文本信息、听觉信号、机械振动、光或者其他视觉显示、触觉显示、外部装置上显示的信息或者其他类型的警报。不同警报模式(例如变化的声音信号、变化的振动模式等)可被用于表示不同的状态。两种或多种警报可在类似条件下被提供给多个人，但警报可以不同时提供给多个人或者根本不提供给任何人。警报的条件和/或警报类型还可相对于警报的接收者而变化。例如，对于用于医生或者其他医护人员的警报，这种警报可被限制为在指示内部部分10a的一些元件在结构上的故障(例如导管50纽结、胃束带20泄露等)的超常事件时提供的那些。对于用于患者的警报，这种警报可被限制为患者活动诸如在指示患者进食过多、进食过快或者患者咬的尺寸过大时提供的那些。本领域技术人员可想到警报可被引导到医生、患者和/或其他人的各种其他条件。本领域技术人员可想到用于检测警报启动的其他合适过程、警报可被提供的方式以及提供警报的定时(例如在检测到数据的一些转折点或模式之后在正常时间表诸如每天或者每小时立即提供)。
微控制器62可任选地在将数据存储到存储器162中(步骤412)之前压缩数据(步骤410)。这种压缩可减少将数据存储在内部部分10a(并随后存储在外部部分10b)中所需的存储空间大小，减少微控制器访问存储器162的次数(由此节省功率)，减少将数据从传感器外壳60传递到外部装置所需的时间长短和/功率大小，并允许更多的数据在被传递到外部装置之前本地存储。虽然压力数据在图8中显示为在确定数据的存储到存储器162中的所选部分之后被压缩，但也可以是微控制器65在进行诸如确定之前压缩数据。例如，如上所述，微控制器65可在进行这样的确定之前存储压力数据(步骤412)(可能随后检索该数据用于分析)。作为另一个例子，微控制器65可不被构造成进行这样的确定分析并可存储所有的数据以便传递给外部装置(步骤412)。
微控制器65可使用任何一种或多种无损和/或有损压缩技术压缩数据。无损压缩技术的非限制性的例子包括记录差值(而不是绝对值)、在确定时间段(例如在数据收集时间的一定时间段之后的静压力时间段等)内降低传感器的数据采样速度(其可包括将传感器的数据采样速度降低到0)、游程码、赫夫曼编码以及其他类型的无损压缩技术。有损压缩技术的非限制性的例子包括使用量化表(例如稀疏量化)和其他类型的有损压缩技术。如果典型地在压力测量开始时和以有规律的间隔微控制器65将绝对值存储在存储器162中，存储差值而不是绝对值可进行有效的压缩，则其可用作重建原始的感测数据的基线。感测压力值常常在它们的相邻值附近，与基线的差即便不为0也常常可能很小。微控制器65可使用压缩技术压缩差值用于存储，诸如将差值编码到赫夫曼编码中的最短代码符号中。
存储在存储器162中的数据可被传递到外部装置(步骤414)。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(步骤414)，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(步骤416)。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(步骤418)。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(步骤420)。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(步骤422)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)(步骤424)。
如上所述，压力历史(例如由传感器62收集的压力数据)可传递到控制箱90(和/或定位在本地或者远离患者的其他单元)，以便允许人以物理的方式评估和/或控制箱90以电子的方式评估在指定时间段内患者的治疗和/或包括在内部部分10a中的元件的性能。图11示出了外部装置的一种实施方式，数据记录器270可被用作外部存储机构来存储一段时间内的压力测量值。数据记录器270可用作可拆卸地连接的上述数据读取装置70。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，在所述区域下方传感器外壳60植入患者体内。作为替代，数据记录器270可围绕在患者的脖子上佩戴，如图由装置270’所示，诸如当注射端口30被植入到患者的胸骨上并且注射端口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还可被植入到患者体内。
如图11所示，数据记录器270包括TET线圈285和遥感线圈272，它们可由患者穿戴以便与内部部分10a靠近地定位。TET线圈285可为植入物提供功率，而遥感线圈272可询问植入物并可通过植入部分10a中的次级遥感线圈114接收数据信号，包括压力测量值。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。
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12更详细显示了数据记录器270。如图12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连接以便至少存储来自内部部分10a的压力测量值。在该实施方式中，存储器280包括40MB的非易失性的电可擦除只读存储器(EEPROM)或者闪存并被构造成存储大约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，但压力可以由微处理器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的响应的任选温度调节的压力读数。压力读数可通过遥感线圈272被接收并由收发器284引导到微处理器276。微处理器276可存储压力测量值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。
当结束测量和记录压力时，数据记录器270可从患者身上和/或从带子274上除去并且记录的压力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感测的压力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”开关被启动以将压力数据下载到控制箱90中的存储器138中。在压力数据被下载之后，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上以便继续进行压力测量。
数据记录系统300的替代实施方式在图13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13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14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12对所述元件的讨论也可被应用于图14中显示的元件。在图14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14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)的信号和指示温度的信号。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、RF、光、感应等)都可被单独或者组合使用，并且与线圈不同的替代通信装置可被使用。此外，不同数据处理可对给定通信技术更有利，并且对于给定特定通信技术，可选择合适的数据处理。
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，以便将压力测量值记录在存储器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，在夜间可将所述压力测量值记录在存储器280中，并且压力测量值可在一天内24小时记录。在该方式中，压力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中并以与压力数据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，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。
虽然上面描述的实施方式包括在可拆卸地连接到导管50的传感器外壳60中的压力传感器62的使用，但是压力传感器可被定位在患者体内的任何地方。例如，压力传感器62可被包括在端口外壳30中。在图15中显示的另一种实施方式中，压力传感器500可被定位在胃束带502中，诸如胃束带502的可膨胀部分中。如果胃束带502包括弹性部分和非弹性部分，压力传感器500可被连接到弹性部分或者非弹性部分，或者与两者都不连接。在任何情况下，压力传感器500可在经注射端口501和导管503向胃束带502中加入流体或者从胃束带502中抽出流体之前、过程中和之后感测胃束带502中的流体压力并传递该流体压力。当泵(未显示)或者任何其他装置被用于调节胃束带502中的压力时，压力传感器500可被使用。
作为替代，如图16中所示，压力传感器504可被定位在位于胃束带508与注射端口507之间的导管506中、泵、容器或者与导管506流体连通的其他装置中。作为另一种变型，在图17中显示的例子，压力传感器509可与导管506串联固定连接，而不保留在导管506中。
在图18中显示了又一种变型，其示出了具有“T”形交叉部550的导管506。压力传感器504设置在与导管506垂直并与导管506流体连通的“T”形交叉部550的臂中。在一种实施方式中，“T”形交叉部550与导管506一体形成(如图所示)。在另一种实施方式中，“T”形交叉部550是与导管506连接(例如使用带倒刺的连接器等)的独立元件。本领域技术人员可想到“T”形交叉部550可被提供的其他合适的方式。类似地，本领域技术人员可想到压力传感器504可被设置到导管506中、与导管506串联或者与导管506相邻的其他方式。
在还一种实施方式中(未显示)，压力传感器可被定位在注射端口与导管的界面处，和/或在胃束带与导管的界面处。本领域技术人员可想到压力传感器的其他合适的位置，包括但不限于胃束带系统的流路中的任何位置或者与之相邻的任何位置。另外，压力传感器可被定位在胃束带中(例如抵靠胃束带的内壁)、导管中和带扣中，或者作为替代，所述胃束带、导管和带扣的一部分可包括从其向外延伸的突起，以便容纳相应的压力传感器的至少一部分。本领域技术人员可想到用于将压力传感器容纳在胃束带中、导管中或带扣中或者与之相邻的其他合适构造。
在另一种实施方式中，可使用多个压力传感器。例如，除了与胃束带流体连通的导管中的压力传感器之外，胃束带系统还可包括处于胃束带中的压力传感器。所述多个压力传感器可提供流体压力在胃束带系统的元件中分布情况的指示。所述多个压力传感器还可提供更精确的压力读数、减小影响压力读数的导管阻塞(例如夹紧)的可能性、减小来自患者运动的静压力变化的影响、和/或提供一个或多个其他结果。除了任何上述植入的压力传感器之外，包括多个压力传感器的任何系统可包括处于注射端口外壳中的压力传感器和/或在患者体外的压力传感器(例如在注射器中的压力传感器或者在与注射器连接的压力传感器部分中的压力传感器)。此外，装置诸如内部或者外部倾斜计(或者其替代物)可被用于确定患者和/或内部部分的朝向(例如直立、躺下等)的角度，其可被作为因子考虑到由一个或多个传感器感测的压力数据中以说明由患者的朝向引起的静压力的影响。这样的因子(或者任何其他因子)可在进行压力读取之前或者与其结合被说明。
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系统，包括：
能够在患者体内形成限制的可植入的限制装置；和
与所述可植入限制装置通信的可植入的感测装置，该感测装置被构造成感测有关所述可植入的限制装置的参数并将考虑到相对于有关所述可植入的限制装置的标称参数值的数据变化的数据的所选部分传递到外部装置。
2、如权利要求1所述的系统，其中，所述参数包括压力、脉冲计数、脉冲宽度和幅值中的至少一种。
3、如权利要求1所述的系统，其中，所述感测装置还被构造成，当所述外部装置以遥感方式将至少一些功率提供给所述感测装置时，所述感测装置将数据传递到所述外部装置。
4、如权利要求1所述的系统，其中，所述感测装置被构造成放弃基本上等于标称值的数据。
5、如权利要求1所述的系统，其中，所述感测装置被构造成根据所述数据是否包括处于限定范围内的值而传递所述数据的所选部分。
6、如权利要求1所述的系统，其中，所述感测装置被构造成将数据与标称值进行比较。
7、如权利要求1所述的系统，其中，所述感测装置被构造成在将所述数据的所选部分传递到所述外部装置之前存储所述数据的所选部分。
8、如权利要求1所述的系统，其中，所述数据的所选部分在被传递到所述外部装置之前被压缩。
9、一种用于在患者体内形成限制的限制系统，包括：
能够在患者体内形成限制的可植入的限制装置；
与所述可植入限制装置通信的可植入的压力感测装置，该压力感测装置被构造成感测所述可植入的限制装置中的压力；以及
能够在任何感测的压力数据被传递到外部读取装置之前确定是否存储任何感测的压力数据的处理器。
10、如权利要求9所述的系统，还包括被构造成存储感测的压力数据并将存储的压力数据传递到外部装置的外部存储机构。
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