CN101467923B - 可调节限制装置中的压力控制 - Google Patents
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Abstract
本发明涉及可调节限制装置中的压力控制，尤其是提供了用于调节包括限制装置的液压限制系统的方法和装置。一般说来，所述方法和装置可允许非侵入的瞬时压力控制。在一些实施方式中该方法和装置还可以机械方式调节限制装置中的压力，而不需要使用可能需要被供电以便在延长的时间段运行的任何电子元件。
Description
技术领域
本发明涉及可植入的限制装置，具体涉及用于限制系统中瞬时压力控制的方法和装置。
背景技术
随着肥胖人数持续增加以及对肥胖对健康的负面影响了解的越来越多，肥胖越来越受到关注，特别是在美国。其中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，大量的注意力被集中到治疗肥胖患者上。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流体的弹性囊，所述囊紧邻食道-胃结合部之下围绕胃，从而在束带上方形成小的胃袋并在胃中形成减小的人造口。当流体注入囊中时，束带膨胀压迫胃，在胃中形成食物摄入限制部或者人造口。为了减小这种限制，将流体从束带中去除。束带的作用是减小可利用的胃体积，并由此在变得“饱胀”之前减少可被消耗掉的食物量。
使用上述食物限制装置的每一种来安全有效地处理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将会显著增加。因此，胃中的人造口开口最初必须被制得大到足够使患者能够接收足够养分，同时胃适应束带装置。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态的变化，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按照计划看医生，在此时使用休伯针和注射器穿刺患者皮肤并将流体加入到囊中或者从囊中除去。最近，已经发展了能够非侵入地调节束带的可植入泵。外部程序装置使用遥测技术与植入的泵通信，对泵进行控制。在按照计划看医生期间，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。植入物进而调节束带中的流体水平并将响应命令传递给程序装置。虽然这种泵可以是有效的，但它们需要电力来运转，因而要求患者为使泵正确运转和被保持而看医生。
因此，仍然需要用于调节液压限制系统的方法和装置，特别是不需要使用电力而运转的方法和装置。
发明内容
本发明总体上提供了用于调节液压限制系统的方法和装置。在一种实施方式中，提供了在患者体内形成限制的系统，该系统包括：可在通路中形成限制的限制装置，可在流体源和限制装置之间泵送流体的泵送机构，以及与泵送机构联接的能量释放机构。能量释放机构可释放存储的位能以致动泵送机构，从而在流体源与限制装置之间诸如通过使用齿轮传动系统泵送流体。将流体泵送到限制装置中可有效地增加由限制装置形成的限制大小。在一些实施方式中，泵送机构可沿着远离流体源的单方向将流体泵送到限制装置中。另外，泵送机构可被构造成仅仅当能量释放机构不释放储存的位能来致动泵送机构时允许来自限制装置的流体的释放。
系统可具有任意数目的变化。例如，系统可包括与能量释放机构联接并可储存位能的能量储存机构。在一些实施方式中，系统还可包括与能量储存机构联接并可接收能量并将接收的能量传递给能量储存机构的能量补充机构。在一些实施方式中，能量储存机构可接收由来自体内植入能量补充机构的患者的运动的动能转化的能量。能量储存机构和能量补充机构可彼此流体连通，通过将流体从能量补充机构输送到能量储存机构中使能量可从能量补充机构释放到能量储存机构中。在一些实施方式中，能量补充机构可接收来自不与限制装置流体连通的第二流体源的流体。在一些实施方式中，能量补充机构可接收施加的由体内植入能量补充机构的患者的运动获得的动能。
在另一种实施方式中，用于在患者体内形成限制的系统包括：可在通路中形成限制的限制装置；和与限制装置联接并且当柔性泵被手动致动时可将流体从流体源(例如植入的流体容器)释放到限制装置中的柔性泵。将流体加入到限制装置中可增加由限制装置形成的限制大小。所述系统还可包括阀(例如单向阀)，该阀与限制装置联接并且当限制装置中的流体压力大于预设压力限时可打开以允许流体流出限制装置，所述预设压力限可是固定的或可调节的。阀可任选地与流体源联接并被构造成打开以允许流体流出限制装置并进入流体源。在一些实施方式中，所述系统包括与限制装置联接并具有锁定位置的第二阀，当从锁定位置手动释放(诸如通过在第二阀的植入位置附近运动外部装置)时第二阀可打开以允许来自限制装置的流体流动并进入流体源中。
系统可具有任意数目的变化。例如，柔性泵可被植入组织下方并可通过组织手动致动。作为另一个例子，柔性泵可通过体内被植入柔性泵的患者的运动在患者体内手动致动。在一些实施方式中，所述系统可包括阀，该阀联接在柔性泵与限制装置之间并可允许柔性泵沿着单个方向将流体从流体源泵送到限制装置中。
在其他方面，提供了一种在患者体内形成限制的方法。所述方法包括将能量施加到能量补充机构，该能量补充机构将能量传递到储存能量的能量储存机构。能量储存机构可释放被储存的能量，从而使流体从流体源流动到被植入以在通路中形成限制的限制装置中。从流体源到限制装置中的流体流动可增加由限制装置施加到通路中的限制大小。在一些示例性实施方式中，能量储存机构可将能量释放到能量释放机构，该能量释放机构引起泵送机构将流体从流体源泵送到限制装置中。在一些实施方式中，储存在能量储存机构中的能量仅仅当能量补充机构不将能量传递到能量储存机构时才被释放。
能量可以各种方式被施加到能量补充机构。例如，将能量施加到能量补充机构可包括施加由体内植入限制装置的患者的运动产生的动能。作为另一个例子，将能量施加到能量补充机构可包括将磁性装置设置在能量补充机构附近。
在一些实施方式中，当能量被施加到能量补充机构时，流体可从能量补充机构传递到能量储存机构，以便将能量传递给能量储存机构。此外，当能量储存机构释放被储存的能量时，流体可从能量储存机构传递到流体源。
在另一种实施方式中，在患者体内形成限制的方法包括使皮下柔性泵运转，以使流体从流体源流到限制装置中(在一些实施方式中沿着从流体源向限制装置的单方向)，所述皮下柔性泵与被植入以便在通路中形成限制的限制装置联接。当限制装置中流体压力大于与限制装置联接的阀的预设压力限时，阀打开，以便允许流体流出限制装置。预设压力限可以是固定的或者可以调节的。在一些实施方式中，当与限制装置联接的第二阀从锁定位置被手动释放时，流体可向着流体源流出限制装置。
更具体地，本发明涉及如下内容：
(1)、一种在患者体内形成限制的系统，包括：
被构造成在通路中形成限制的限制装置，限制大小与所述限制装置中流体的量对应；和
与所述限制装置联接并被构造成接收能量的控制机构，其中供应到所述控制机构的能量有效地增加所述限制装置中的流体压力，并且所述控制机构限定流体压力不能超过的最大压力。
(2)、一种在患者体内形成限制的系统，包括：
被构造成在通路中形成限制的限制装置；
被构造成在流体源和所述限制装置之间泵送流体的泵送机构；知
与所述泵送机构联接的能量释放机构，该能量释放机构被构造成释放存储的位能以致动所述泵送机构，使得所述泵送机构在流体源与所述限制装置之间泵送流体。
(3)、如第(2)项所述的系统，其中将流体泵送到所述限制装置中有效地增加由所述限制装置形成的限制大小。
(4)、如第(2)项所述的系统，还包括与所述能量释放机构联接并被构造成储存位能的能量储存机构。
(5)、如第(4)项所述的系统，还包括能量补充机构，该能量补充机构与所述能量储存机构联接，并被构造成接收能量并且将接收的能量传递给所述能量储存机构。
(6)、如第(5)项所述的系统，其中所述能量储存机构和能量补充机构彼此流体连通，并且通过将流体从所述能量补充机构输送到所述能量储存机构中使能量从所述能量补充机构释放到所述能量储存机构中。
(7)、如第(6)项所述的系统，其中所述能量补充机构被构造成接收来自不与所述限制装置流体连通的第二流体源的流体。
(8)、如第(5)项所述的系统，其中所述能量补充机构被构造成接收被施加的动能，所述动能通过体内植入所述能量补充机构的患者的运动而获得。
(9)、如第(5)项所述的系统，其中所述能量储存机构被构造成接收动能，所述动能通过体内植入所述能量补充机构的患者的运动而获得的动能转化而来。
(10)、如第(2)项所述的系统，其中所述能量释放机构被构造成使用齿轮传动系统致动所述泵送机构。
(11)、如第(2)项所述的系统，其中所述泵送机构被构造成沿着离开流体源并进入所述限制装置中的单方向泵送流体。
(12)、如第(11)项所述的系统，其中所述泵送机构被构造成仅仅当所述能量释放机构没有正在释放储存的位能以致动泵送机构时允许流体从所述限制装置中释放。
(13)、一种在患者体内形成限制的方法，包括：
将能量施加到将能量传递到储存能量的能量储存机构的能量补充机构，所述能量储存机构释放被储存的能量，以便使流体从流体源流动到被植入以在通路中形成限制的限制装置中。
(14)、如第(13)项所述的方法，其中从流体源到限制装置中的流体流动增加由所述限制装置施加到通路中的限制大小。
(15)、如第(13)项所述的方法，其中施加能量包括施加由体内植入所述限制装置的患者的运动产生的动能。
(16)、如第(13)项所述的方法，其中施加能量包括在能量补充机构附近设置磁性装置。
(17)、如第(13)项所述的方法，其中当能量被施加到能量补充机构时，流体被从能量补充机构输送到能量储存机构中，从而将能量传递到能量储存机构。
(18)、如第(17)项所述的方法，其中当能量储存机构释放被储存的能量时，流体被从能量储存机构输送到流体源。
(19)、如第(13)项所述的方法，其中储存在能量储存机构中的能量仅仅当能量补充机构没有正在将能量传递到能量储存机构时才被释放。
(20)、如第(13)项所述的方法，其中能量储存机构将能量释放到能量释放机构，能量释放机构引起泵送机构从流体源将流体泵送到限制装置中。
(21)、一种在患者体内形成限制的系统，包括：
限制装置，其被构造成在通路中形成限制；
柔性泵，其与限制装置联接并被构造成当柔性泵被手动致动时将流体从流体源释放到限制装置中；和
阀，其与限制装置联接并且被构造成当限制装置中的流体压力大于预设压力限时打开，以允许流体流出限制装置。
(22)、如第(21)项所述的系统，其中所述阀包括单向阀。
(23)、如第(21)项所述的系统，其中所述阀与流体源联接并被构造成打开以允许流体流出限制装置并进入流体源。
(24)、如第(21)项所述的系统，其中所述预设压力限是可调节的。
(25)、如第(21)项所述的系统，其中所述柔性泵被构造成植入到组织下方并可通过组织手动致动。
(26)、如第(21)项所述的系统，其中所述柔性泵被构造成通过体内植入柔性泵的患者的运动在患者体内手动致动。
(27)、如第(21)项所述的系统，其中还包括联接在柔性泵与限制装置之间的阀，该阀被构造成允许柔性泵沿着从流体源到限制装置的单个方向泵送流体。
(28)、如第(21)项所述的系统，其中当流体加入到限制装置中时限制装置有效地增加由限制装置形成的限制大小。
(29)、如第(21)项所述的系统，其中柔性泵被构造成从植入的流体容器将流体泵送到限制装置中。
(30)、如第(21)项所述的系统，还包括与限制装置联接的第二阀，该第二阀具有锁定位置并被构造成从锁定位置手动释放时打开以允许流体从限制装置流到流体源中。
(31)、如第(30)项所述的系统，其中第二阀被构造成通过在第二阀的植入位置附近运动外部装置而从锁定位置被释放。
(32)、一种在患者体内形成限制的方法，包括：
使与被植入以便在通路中形成限制的限制装置联接的皮下柔性泵工作，从而使流体从流体源流到限制装置中，其中，当限制装置中流体压力大于与限制装置联接的阀的预设压力限时，阀打开以便允许流体流出限制装置。
(33)、如第(32)项所述的方法，其中柔性泵沿着从流体源向着限制装置的单个方向泵送流体。
(34)、如第(32)项所述的方法，其中当与限制装置联接的第二阀从锁定位置被手动释放时，流体从限制装置流出并向着流体源流动。
(35)、如第(32)项所述的方法，其中还包括调节预设压力限。
附图说明
通过下列结合附图的详细描述，可更全面地理解本发明，在附图中：
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立体图；
图2A是图1A的食物摄入限制装置的胃束带的立体图；
图2B是应用到患者的胃食管结合部周围的图2A的胃束带的示意图；
图3是图1A的食物摄入限制装置的注射端口外壳的一种实施方式的立体图；
图4是具有瞬时压力控制系统的食物摄入限制系统的原理图；
图5是瞬时压力控制系统的一种示例性实施方式的方框图；
图6是图5的瞬时压力控制系统的一种示例性构造的示意图；
图7是用于食物摄入限制系统的外部磁性装置的示意图；
图8是食物摄入限制系统的另一种示例性实施方式的示意图，该系统具有带皮下泵的瞬时压力控制系统；
图9是显示出用于图8的食物摄入限制系统的瞬时压力控制方案的一种实施方式的流程图；
图10是用于图8的食物摄入限制系统的超声致动的阀组件的示意图；
图11是显示出图8的食物摄入限制系统中样品压力测量值的视图。
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、制造以及使用的原理的全面理解。这些实施方式的一个或多个例子在附图中示出。本领域普通技术人员将会理解，在本文中特别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，并且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。
本发明总体提供了用于调节被构造成在通路中形成限制的液压限制系统的方法和装置。一般说来，所述方法和装置可允许使用可植入的控制机构进行非侵入的瞬时压力控制。在一些实施方式中，所述方法和装置还可以机械方式调节限制装置中的压力，而无需使用需要被供电以便在延长的时间段运转的任何电子元件。
虽然本发明可被用于本领域已知的多种限制系统，在一种示例性实施方式中所述装置和方法被用于胃限制装置。虽然多种类型的胃限制装置是已知的，包括电子、机械和/或以流体为基础的装置，为参考目的，在这里公开的装置和方法结合以流体为基础的胃限制装置的多种实施方式进行讨论，所述胃限制装置如在下述文献中描述的：由Dlugos等人于2006年3月7日提交的、名称为“Non-Invasive Pressure Measurement In A Fluid AdjustableRestrictive Device”的共同拥有的美国专利公开No.2006/0211913(此后称为“Dlugos”)，该文献通过全文引用而包含在本申请中。本领域技术人员将会理解，本文公开的方法和装置不是想要限制为与任何特定的限制装置一起使用。
图1A和图1B示出了如Dlugos中公开的可植入限制系统100的一种实施方式。如图所示，可植入限制系统100通常包括：被构造成围绕患者的胃140的上部定位的可调节胃束带120；和与可调节胃束带120流体联接(例如通过可由一个或多个元件形成的导管150联接)的注射端口130。注射端口130适于允许流体被引入到胃束带120中或者从胃束带120中除去，从而调节胃束带120的尺寸并由此调节施加到胃140上的压力。因此，注射端口130可被植入到体内可穿过组织进入的位置中。典型地，注射端口被定位在患者腹部的位于皮肤和脂肪层下的横向肋下肌区域中。通常，外科医生还将注射端口植入到患者的胸骨上。
图2A更详细地显示了胃束带120。虽然胃束带120可具有多种构造，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120具有大致细长形状，并带有具有可形成环形以彼此连接的相对的第一末端120a和第二末端120b的支撑结构122。各种配合技术可被用于将末端120a、120b彼此连接起来。在图示的实施方式中，末端120a、120b为配合在一起的条带形式，并且一个条带叠置于另一个条带的顶部上。支撑结构可被包括在胃束带120的一端上，并且该支撑结构可具有胃束带120的另一端可从中穿过以便将两个末端彼此连接的开口。胃束带120还可包括可变体积构件，诸如可膨胀囊124，该可变体积构件设置在或形成在支撑结构122的内侧上并被构造成邻近组织定位。囊124可贴靠胃的外壁膨胀或者收缩，以便形成可调节人造口，从而可控制地限制摄入到胃中的食物。囊124可接收流体而膨胀和释放流体而收缩。囊中的流体量可与由胃束带120形成的限制大小对应。因此，可使用胃束带120中的流体调节来控制由胃束带120形成的限制大小。
本领域技术人员将会理解，胃束带120可具有各种其他构型。而且，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限制装置。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，该文献通过全文引用而包含在本申请中。束带还可被用于治疗小便失禁，如同在美国专利申请No.2003/0105385中描述的那样，该文献的内容通过全文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，该文献的内容通过全文引用而包含在本申请中。束带还可被用于治疗阳痿，如同在美国专利申请No.2003/0114729中描述的那样，该文献的内容通过全文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120。如图所示，胃束带120至少大体上围绕胃140的与患者食管142的结合部附近处的上部。在胃束带120优选在胃束带120中容纳少量或者不含流体的收缩构型中被植入后，胃束带120可例如使用生理盐水被膨胀，从而减小人造口开口的尺寸。本领域技术人员将会理解，多种技术，包括在下面公开的那些技术都可被用于调节由胃束带120形成的限制大小。
流体注射端口130也可具有多种构造，其可任选地被提供以允许流体或者其他材料被引入系统100的各个元件中，诸如胃束带120、将在下面详细讨论的瞬时压力控制机构160、和/或一个或多个流体源。注射端口130可具有各种构造。在图3中显示的实施方式中，注射端口130具有大致圆柱形外壳，该外壳具有远侧表面或底面以及从所述底面向近侧延伸并限定了近侧开口132的周壁。近侧开口132可包括延伸穿过其中并提供了在外壳中形成的流体源或者容器(在图3中不可见)的入口的针穿刺隔膜134。隔膜134优选设置在近侧位置，该近侧位置足以使容器的深度足够暴露针(诸如休伯针)的开口尖端，从而能够进行流体输送。隔膜134优选被设置成使其在被针穿刺并且针退出后自我密封。如图3中进一步显示的那样，注射端口130可还包括导管连接构件136，该导管连接构件136与容器流体连通并被构造成与导管(例如导管150)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，典型的为生物相容性材料，诸如不锈钢，钛或者聚合物材料，隔膜134同样可由任意数目的材料制成，典型的为生物相容性材料，包括硅树脂。此外，系统也可不具有注射端口130。各种构造都是可能的，并且任何已知的限制系统或者装置都可被用于本发明。
图示的系统100还包括与胃束带120串联地设置的控制机构160和可包括在注射端口130中或者可定位在系统100内任意位置的流体源(将在下面进一步讨论)。虽然控制机构160可设置在任何位置以便允许流体输送到胃束带120，在图示的实施方式中，导管150包括联接在胃束带120与控制机构160之间的第一部分和联接在控制机构160与注射端口130之间的第二部分。如同下面进一步解释的那样，控制机构160可控制地将流体从流体源释放到胃束带120中，以便帮助保持胃束带120中的所需的流体压力。以此方式，控制机构160可允许非侵入的压力控制。在示例性实施方式中，控制机构160还可以机械方式调节胃束带120的压力，而不需要使用可能需要被供电以在延长的时间段运行的任何电子元件。
图示的系统100还可任选地包括传感器，诸如用于读取系统100的封闭流路中的流体压力的压力读取传感器134。但是压力读取装置134不需要被包含在系统100中，而仅仅作为任选特征元件被显示。虽然Dlugos公开了压力读取装置134，但装置可以是用于感测系统100的各种参数或者置于系统100之外的任何感测装置。感测装置还可具有各种构造，并且其可联接于或者定位于限制系统100中的任何位置。在图1A中示出的实施方式中，压力读取装置134与注射端口130联接。除了感测封闭系统中流体的压力之外，食管、胃140或者其他体腔中流体的压力都可使用任何合适的装置来感测，诸如内窥镜式压力计。作为非限制性的例子，这种流体压力测量值可与系统100中压力调节之前、调节过程中和/或调节之后系统100内测定的流体压力来比较。食管、胃140或者其他体腔中的测定的压力的其他合适用途对于本领域技术人员来说都是可以理解的。在需要时，传感器还可被构造成测定其他生理参数。图2B显示了设置在胃束带120的带扣143中的感测装置141的替代位置。
如前所述并如图4中所示，控制机构160可与胃束带120和流体源170串联设置。流体源170可具有各种构造，并且系统100可包括任意数目的流体源。例如，流体源170可以是通过导管(例如导管150)或者其他连接器与控制机构160联接的刚性或柔性外壳的形式。作为另一个例子，流体源170可以是人体(例如胃、腹膜、肺、通过渗透产生的生理盐水、胞内液、血液等)。导管或者其他通路可从控制机构160延伸到需要获得和/或释放流体的体内位置。如上所述，流体源170还可或者作为替代地被包括在注射端口130中。因此，注射端口130在图4中以虚线轮廓被显示，因为在一些实施方式中，流体源170和注射端口130可以是同一外壳的部分，在这种情况下图4的流体源170也可代表注射端口130。另外，如果流体源170不设置在注射端口130中，该流体源170可以或者可不通过导管(例如导管150)或者其他连接器与注射端口130流体连通。
多种控制机构可被用于控制胃束带120中的流体压力。控制机构160(包括控制机构160中的每个元件)可具有任意构造、尺寸和形状，并可由任意类型任意材料的组合制成，典型地为适于体内使用的生物相容性材料，诸如聚合物、生物相容性金属以及其他相似类型的材料。在示例性实施方式中，控制机构160可以是机械控制而非电控制，从而不需电力。在使用时，控制机构160可被构造成例如借助皮下泵送、惯性泵送或者机械泵送来接收能量，并被构造成使用该能量调节胃束带120的压力。在示例性实施方式中，控制机构160将压力保持在一范围内，并且该范围的上限被预设(固定的或者可由用户调节的)，该范围的下限由例如随着患者体重减轻等靠近胃束带120的组织产生的力的减小限定，如同在限制系统中观察的那样。在一些示例性实施方式中，可通过控制机构并任选地通过允许流路的低压部分中的流体被释放或者进入体内而保持上限。图5示出了控制机构160的一种示例性实施方式。如图所示，控制机构160包括能量机构180和泵送机构(诸如泵190)。一般说来，在使用时，能量可被施加到可储存能量的能量机构180。能量机构180可释放被储存的能量以致动泵190，从而引起流体从流体源170流到胃束带120中。
能量机构180可具有各种构造，但在一种示例性实施方式中，能量机构180包括：与流体源170联接的能量补充机构182：与能量补充机构182联接(并任选地与流体源170联接)的能量储存机构184；以及与能量储存机构184联接的能量释放机构186。泵190可与能量释放机构186联接。包括在能量机构180中的一个或多个元件可以任意组合组合在一起。例如，能量补充机构182和能量储存机构184可包括被构造成接收应用的能量并储存接收的能量的单个外壳。能量补充机构182可接收输入到能量机构180的能量并将接收的能量输送到能量储存机构186。
能量补充机构182可以各种方式接收能量。例如，能量可作为施加的动能被输入到能量补充机构182中，诸如通过体内植入胃束带120的患者的运动。与自动上发条的表机构类似，如图6中的实施方式所示，质量块192可响应于患者的运动而振荡。质量块192的振荡可将力施加到能量补充机构194，例如施加到偏压元件(诸如设置在能量补充外壳194中的弹簧196)。弹簧196可以是具有任何形状的任何柔性弹性物体。例如，弹簧196可以是具有如图6所示的圆柱形的盘簧或者螺旋弹簧，但弹簧196也可具有其他形状，诸如圆锥形或者双圆锥形(dual conical)，并且其可具有任何形状的单个圈，诸如椭圆形或者矩形。偏压元件的其他例子包括弹性带，螺线或者绳索，膜盒，锥形弹簧以及其他相似类型的柔性弹性物体。弹簧196还可以具有各种尺寸，而且如果使用一个以上的弹簧，则在能量补充机构182中使用的不同弹簧可具有不同尺寸和形状。此外，如果在能量机构180中的任何位置使用一个以上的弹簧或者其他偏压元件，则每个偏压元件可以与能量机构180中的任何其他偏压元件相同或者不同。
质量块192和弹簧196每个都可与设置在能量补充外壳194中的弹簧联接机构198的相对侧联接。弹簧联接机构198通常将能量补充外壳194分成具有相反(inverse)关系的下部腔200a和上部腔200b两个腔，下部腔200a包括弹簧196，上部腔200b与质量块192和流体源170联接并被构造成容纳流体。
当质量块192运动时(例如上下运动，从一侧向另一侧运动，旋转运动等等)，力可被施加到可在能量补充外壳194中上下运动(诸如通过设置在弹簧联接机构198的端部处的轴承202a、202b沿着能量补充机构外壳194的滑动)的弹簧联接机构198上。(在这里讨论的“上”和“下”方向相对于涉及的元件的朝向。取决于被植入元件的朝向和/或被植入元件的患者的位置，“上”和“下”在不同时刻以及对于不同患者时可不同。)当弹簧联接机构198向下运动时，弹簧196可在能量补充外壳194中被压缩，从而减小了下部腔200a的尺寸，同时增加了上部腔200b的尺寸。当被扩大时，上部腔200b可填充有来自流体源170的流体，该流体源具有比上部腔200b小的压力。阀162(见图5)可允许流体沿着从流体源170到能量补充机构182的方向流动。
流体源170可以是用于能量补充机构182和能量储存机构184(将在下面解释)的专用流体源，例如流体源170不必与胃束带120流体连通。如果流体源170是这种专用的，则能量机构180的植入位置的更多选择可以被利用，因为对包括在胃束带120的封闭流路中的任何元件而言不需要很容易接近或者根本不必接近流体源170。在一些实施方式中，分别位于能量补充机构182和能量储存机构184的流体用上部腔200b、210b可包含任意量的水凝胶，所述水凝胶可包括任何材料，典型地为生物相容性、水溶性聚合物材料。随着流体引入到流体用上部腔200b、210b中，水凝胶可膨胀，从而向下推动各个弹簧联接机构198、214。能量补充机构182和能量储存机构184可以但不必在它们各自的外壳194、212中包括联接到弹簧联接机构198、214的弹簧196、218，因为水凝胶可提供足够的偏压力。当流体流出流体用上部腔200b、210b时，水凝胶收缩，从而允许各个弹簧联接机构198、214向上运动。
能量补充机构182可被构造成接收有限量的能量。例如，无论是由刚性还是柔性材料制成，能量补充外壳194的流体用上部腔200b可具有可保持有限量流体的内部区域。在能量补充过程中的一些时刻，能量补充机构182可被完全充满。例如，质量块192可振荡，但弹簧196可能被完全压缩(例如，弹簧联接机构198不能在能量补充外壳194内部进一步向下运动)，从而表明能量补充机构182被完全充满。在能量补充机构182被完全充满之前可被施加到能量补充机构182的能量的量基于一种或多种因素而变化，例如能量补充外壳194的尺寸、能量补充外壳的合成材料的柔性、上部腔200b中流体的类型、质量块192的尺寸、弹簧196的可压缩性、患者的活动水平等等。可花任何长短的时间对能量补充机构182进行补充(例如十五分钟、一小时、二小时、五小时、十二小时、二十四小时等等)，但优选所花时间的长短少于一天中患者通常处于清醒和运动所花费的时间长短，以便能够允许能量补充机构182在一天中被完全充满。完全充满能量补充机构182所需的能量和/或时间长短可依患者不同而变化，甚至由于患者体重减轻或者可影响患者治疗计划的其他经验变化对于单个患者也会变化。
在另一种实施方式中，能量可从外部源(例如磁体或者其他非侵入性补充装置)输入到能量补充机构182中。外部源可以是运动的(例如可晃动或者设置在能量补充机构182附近的棒或者手持单元)或者静止的(例如安装在床边、桌子或墙壁上或者患者可在其附近运动的车载箱)。任何用户都可如此手动输入能量(例如体内被植入有胃束带120的患者、医生、其他医务人员等等)。
例如，如图7中所示，磁性装置204可设置在能量补充机构182附近，能量补充机构182可被包括在控制机构160中。磁性机构204可被定位在皮肤表面上并位于能量补充机构182(其可被植入到厚的组织下方，例如超过10cm厚)的上方，以便以非侵入方式将能量施加到能量补充机构182。磁性装置204可以是独立的装置，或者其可以与可显示能量补充机构182的磁性装置补充状态和/或任何其他数据的控制箱(无线或者有线)电联接。虽然在该例子中显示控制箱208定位在患者本地，但是控制箱208既可以定位在患者本地，也可以是远程的。当设置在能量补充机构182附近时，磁性装置204可将磁力施加到能量补充机构182，能量补充机构182可上紧(wind)磁力驱动的弹簧，例如弹簧196。如果弹簧196是磁力驱动的，则能量补充机构182不需要包括质量块192。
再次参见图6，能量补充机构182还可将其接收的能量传递到能量储存机构184。虽然各种技术都可被用于传递能量，在一种实施方式中能量储存机构184可接收由来自患者的运动得到的动能转化的能量。为了做到这一点，能量补充机构182和能量储存机构184可彼此流体连通。阀188(诸如如图所示的单向阀)可允许流体沿着能量补充机构182到能量储存机构184的方向流动。当质量块192振荡并且能量补充机构182补充能量时，能量补充机构182可通过将流体从能量补充机构182中的上部腔200b输送到能量储存机构184中的上部腔210b中将能量释放到能量储存机构184中。作为另一个例子，当弹簧196磁性上紧时，能量补充机构182可将流体输送到能量储存机构184。
能量储存机构184可以各种方式储存能量。一般说来，能量储存机构184可储存位能，例如将被释放到能量释放机构186的能量。例如，当能量储存机构184的上部腔210b接收来自流体补充机构182的流体时，上部腔210b的尺寸随着其被填充流体而增大。相应地，与能量补充机构182中的下部腔200a和上部腔200b类似，包括在能量储存机构184的外壳212中的下部腔210a具有与上部腔210b的相反关系，并且当上部腔210b尺寸增加时该下部腔210a尺寸减小(反之亦然，当上部腔210b尺寸减小时该下部腔210a尺寸增大)。而且与能量补充机构182类似的是，能量储存机构184可包括可在外壳212中借助相对的轴承216a、216b运动的弹簧联接机构214。上部腔210b中的流体压力可向下推动弹簧联接机构214，从而压缩设置在下部腔210a中的弹簧218。只要能量补充机构182接收能量，上部腔210b就可填充流体并压缩弹簧218。一旦能量储存机构184已经储存了其可储存的最大量的能量，只要能量被施加到能量补充机构182，弹簧218就保持压缩。随着能量被输入到能量补充机构182中，在能量补充机构的上部腔200b中就可保持比能量储存机构的上部腔210b中更高的压力，该更高的压力与阀188(如果存在的话)一道防止流体从能量储存机构184回流到能量补充机构182。
与能量补充机构182类似，能量储存机构184可被构造成储存有限量的能量。例如，无论由刚性还是柔性材料制成，能量储存机构184的上部腔210b都具有可保持有限量流体的内部区域。当完全被压缩时弹簧218指示能量储存机构184储存了最大量的能量。储存能量的最大量基于一种或多种因素而变化，例如能量储存外壳212的尺寸、能量储存外壳的合成材料的柔性、上部腔210b中流体的类型、弹簧196的可压缩性、至少部分设置在下部腔210a中的齿条220的尺寸等等。可花任何长短时间对能量储存机构184进行能量存储(例如十五分钟、一小时、二小时、五小时、十二小时、二十四小时等等)，但优选所花的时间长短少于一天中患者通常处于清醒和运动所花费的时间长短，以便能够允许能量储存机构184在一天中存储最大量能量。类似地，可花任何长短时间从能量储存机构184将储存的能量释放到能量释放机构186中。能量储存机构184中储存最大量的能量所需的能量和/或时间的长短可依患者不同而变化，甚至由于患者体重减轻或者可影响患者治疗计划的其他经验变化对于单个患者也会变化。
任何机构都可被用于将能量传递到能量释放机构186，但在一种实施方式中，齿条220可被使用。如上所述，齿条220可至少部分地设置在能量储存机构184中，例如设置在包括弹簧218的下部腔210a中。齿条220可以其近侧部分222与弹簧联接机构214联接，并且其远侧部分224可与能量释放机构186联接。齿条220的远侧部分224可具有多个齿226。齿条220可借助可与齿226啮合的棘齿摆轮(ratcheted escapement gear)228与能量释放机构186联接。当能量储存机构184储存能量时(例如当流体填充上部腔210b并向下推动弹簧联接机构214时)，齿条220也可被向下推动。
齿条220可具有能够允许能量从能量储存机构184释放的任何构造。在图示的实施方式中，齿条220在能量储存机构的弹簧联接机构214与摆轮228之间线性延伸为大体上矩形盒状结构，但齿条220也可具有任何二维或三维形状并可具有一个或多个非线性部分。齿条220还可具有任何尺寸，并且其可由任何类型的材料制成，但优选由适用于身体的生物相容性材料制成。在齿条220上形成的齿226也可具有任何形状和尺寸，并且任意数目的齿226可在齿条220上被定向，从而当齿条220沿着合适方向运动时允许与摆轮228接合以及从能量储存机构184释放能量。
能量释放机构186可以各种方式从能量储存机构184释放储存的能量。在图示的实施方式中，能量由响应于齿条220的运动转动的摆轮228释放。摆轮228可具有任何形状和尺寸，并可以由任何材料(典型地为生物相容性材料)构成。摆轮228可包括与齿条齿226啮合的任意数目的齿轮齿230。齿轮齿230还可具有在摆轮228上的任何形状、尺寸和构造。
在示例性实施方式中，摆轮228被构造成带棘齿并具有轴234的构造，以便仅仅沿着一个方向(在该实施方式中为逆时针方向)与轴234一起转动，在能量储存过程中例如当齿条220向下运动时使摆轮228不与轴234一起旋转。当能量从能量储存机构184被释放时，例如当齿条220向上运动并且齿条齿226与齿轮齿230啮合时，摆轮228可与轴234一道转动。摆轮228还被构造成在齿条220不运动时不旋转，例如当能量储存机构184储存最大量的能量但能量补充机构182仍正被补充时。当能量补充机构182正被补充时(例如当弹簧联接元件214被推动或者保持向下时)，齿条220与弹簧联接元件214的联接和/或齿226、230的形状可防止齿条220向上运动(并因此而防止摆轮228的转动)。
当能量储存机构184具有任意储存量的能量并且能量补充机构182没有被补充能量时，能量储存机构184可释放能量。在能量释放过程中，能量储存机构184中的流体可输送到能量储存机构184的上部腔210b之外。流体流经阀206(参见图5)，该阀206允许流体沿着从能量储存机构184向流体源170的单方向流动。作为替代，如果阀188(和阀162)是可切换以允许流体沿着一个方向或者相反方向流动的双向阀，流体可从能量储存机构184流出并流向能量补充机构182，在这种情况下，不需要阀206及其与流体源170和能量储存机构184的相关连接器。当流体流出能量储存机构184时，能量储存机构184的上部腔210b的尺寸减小，从而随着弹簧联接机构214沿着向上的方向运动使相应的下部腔210a的尺寸增加。与弹簧联接机构214联接的齿条220也可向上运动并接合摆轮228并使摆轮228转动。摆轮228可与传动轴234的近端232联接，该传动轴234以其远端236与泵190联接。传动轴234可具有允许其与能量储存机构184以及泵190联接的任何尺寸、形状和构造。在图示的实施方式中，传动轴234在能量储存机构184与泵190之间以大体上圆柱形杆形式线性延伸，但传动轴234也可具有任何二维或三维形状，并可以是非线性的。传动轴234可由任何类型的材料制成。
当摆轮228转动时，传动轴234还可围绕传动轴234的纵向轴线旋转，从而驱动泵190将流体从流体源170泵送到胃束带120中。储存在能量储存机构184中的能量可继续通过储存的能量释放驱动泵190，直到所有储存的能量被释放或者直到能量补充机构182开始再次补充能量。释放能量储存机构184中储存的能量花费的时间长短可变(例如十五分钟、一小时、二小时、五小时、十二小时、二十四小时等等)。用于能量释放的最长时间一般对应于：可被储存在能量储存机构184中的最大量能量的连续而不间断的释放；以及能量补充机构182将最大量能量释放到能量储存机构184中花费的时间长短。这样，泵190可在例如一天结束时患者停止活动后的某一时间段(例如一小时)将流体泵送到胃束带120中。这样，在泵190停止向胃束带120中泵送流体后，胃束带120可以释放流体，从而允许在患者不活动的时间段内(例如夜晚)由胃束带120形成的限制减小。如果胃束带不释放或停止释放流体，例如由于胃束带120中的流体压力小于流体源170中的流体压力、由于没有流体保持在胃束带120中等等，胃束带的压力可至少保持稳定。因此，当患者例如在一天的开始重新开始活动时，在能量储存机构184开始释放储存的能量以驱动泵190时，胃束带120中的压力将不增加并且胃束带的压力可保持一段时间的低水平，所述一段时间由能量补充机构182补充能量的时间长短限定。
泵190可具有允许流体源170与胃束带120之间的流体连通的任何构造，诸如正排量泵(例如螺杆泵、齿轮泵等等)或者离心泵(例如涡旋泵等)。例如，如图6所示，泵190可以是具有传动齿轮238和空转轮240的齿轮泵。传动齿轮238和空转轮240每个都可具有任何形状和尺寸并可由任何材料(典型地由生物相容性材料)构成。传动齿轮238和空转轮240每个都可包括任意数目的齿，这些齿可彼此啮合，从而当传动齿轮238通过传动轴234(其远端236可与传动齿轮238联接)的旋转而被驱动旋转时，也使空转轮240转动。传动齿轮238和空转轮240的齿还可在它们各自的传动齿轮238和空转轮240上具有任何形状、尺寸和构造。泵190可通过导管(例如导管150)或任何其他连接器与流体源170和胃束带120的每一个都联接。如上所述，流体源170可以不是用于能量补充机构182和能量储存机构184的同一流体源。
传动齿轮238和空转轮240的旋转(在该实施方式中沿着逆时针方向)可泵送流体离开流体源170并进入胃束带120，从而增加由胃束带120施加到胃140的限制大小。当能量释放机构186不是正将能量释放到泵190时，泵190可允许流体从胃束带120中释放并进入流体源170。作为替代，在一些实施方式中，一个或多个阀208(参见图5)可设置在流体源170与泵190之间，允许流体沿着从流体源170向胃束带120的单方向流动。这样，当泵190停止运行时(例如当所有能量从能量储存机构184中被释放并且传动轴234停止转动传动齿轮238时)，胃束带120中的压力可被保持。一个或多个阀208可被构造成具有预设最大压力水平，并且当胃束带120中的压力大于预设最大压力水平时打开(将在下面进一步讨论)。一个或多个阀208还可被构造成手动锁定或者打开(同样将在下面进一步描述)。
在其他实施方式中，控制机构160可包括皮下泵送系统，诸如在图8中所示的实施方式中。控制机构160可包括皮下泵送机构，诸如皮下柔性泵242、第一阀244以及第二阀246。一个或多个另外的阀可被包括在系统100中，诸如位于流体源170与柔性泵242之间(从而允许流体沿着从流体源170向柔性泵242的方向流动)和位于柔性泵242与第一阀244之间(从而允许流体沿着从柔性泵242向胃束带120的方向流动)。一般说来，柔性泵242可被手动致动，以便将流体从流体源170释放到胃束带120中。第一阀244可联接在柔性泵242与胃束带120之间，以便允许柔性泵242沿着朝向胃束带的单方向泵送流体。第二阀246可与胃束带120联接，并任选地与流体源170联接，从而当胃束带120中的流体压力大于预设压力限时允许流体沿着离开胃束带120的单方向流动。流体可从第二阀246流出并流到流体源170(在这种情况下流体源170、控制机构160、注射端口130(如果存在并与流体源170分开的话)以及胃束带120可形成闭合流路)或者流到身体中的某一位置。这样，胃束带120中的流体压力可通过使柔性泵242工作并允许流体流进胃束带120而增加，但第二阀246可防止胃束带120中的流体压力超过最大限。第二阀246还可与注射端口130联接，如果通过注射端口130加入到系统100中的流体使胃束带120中的流体压力增加到超过预设压力限，第二阀246可打开，以便允许流体流出胃束带120。
柔性泵242可具有各种构造、形状和尺寸。例如，柔性泵242可包括硅树脂球头，但柔性泵242可由任何类型的材料制成，典型地由适用于体内的生物相容性材料制成。典型柔性泵242在2004年6月2日提交的名称为“Implantable Adjustable Sphincter System”的共同拥有的美国专利申请公开No.2005/0272968中详细公开，该文献的内容通过全文引用而包含在本申请中。一般说来，柔性泵242可植入到组织下方并通过组织手动致动，诸如通过手动方式将压力施加到患者皮肤上并位于设置柔性泵242的部位上方。作为替代，柔性泵242可在患者体内通过腹部肌肉伸缩或者其他身体运动而被触知。优选地，柔性泵242的尺寸设置成泵送合适量的流体而不使患者感到过于受迫。
柔性泵242可被植入到任何皮下位置，诸如在腹腔中。这样，柔性泵242可在患者体内仅仅从一侧通过相对较厚的腹部皮肤借助经皮触摸被致动。柔性泵242可贴靠筋膜设置，该筋膜抵抗向内的压力，以允许通过将压力施加到柔性泵242的与筋膜相对的一侧上而进行泵送操作。例如，体内植入柔性泵242的患者可进行规定的运动(例如俯身、肌肉伸缩、一次或多次起坐等)，患者的活动可在体内压缩柔性泵242。
第一阀244和第二阀246还可具有各种构造、形状和尺寸。第一阀244和第二阀246的例子包括本领域技术人员已知的单向阀和排出阀。示例性的阀详细地公开于下列文献中：共同拥有的美国专利申请公开No.2005/0272968(前面已经提到)以及与本申请同一天提交的题为“Fluid Logic for Regulating Restriction Devices”(代理卷号：No.100873-220(END6278))的美国专利申请，上述文献的内容通过全文引用而包含在本申请中。例如，第二阀246可被预设(固定的或者可调节的)以便在预设压力下打开，从而允许设定系统中的最大压力。系统中的最小压力可由可被输送到胃束带120中的流体量(例如流体源170中以及包括胃束带120的封闭流路中的任何位置的流体量)限定，并且最小压力与最大压力一起可限定所需的可控制压力范围，以用该范围控制压力。
如图所示，在图9中显示的过程的一种实施方式中，包括柔性泵242和阀244、246的控制机构160可大致控制胃束带120中的压力。虽然图9中显示的过程参照包括在图1A-图4及图8(以及下面的图10)中的元件被讨论，本领域技术人员将会理解，该过程可被修改，以便在各种构造中包括更多或更少的元件，并且其可在系统100中或者在另一种具有其他类似元件的类似系统中被执行。
在使用时，柔性泵242可被致动(步骤252)，以引起流体254从流体源170流进柔性泵242中并从柔性泵242通过第一阀244(步骤254)流入胃束带120中(步骤256)。柔性泵242可以各种方式被致动(步骤252)，诸如如上所述地通过手动经皮触摸柔性泵242以致动。由柔性泵242产生的压力最终将超过使第一阀244打开的压力，从而引起流体从流体源170经第一阀244流到胃束带120中。如上所述，阀(例如单向阀)可联接在流体源170与柔性泵242之间，允许流体沿着从流体源170向柔性泵242的方向流动，同时防止流体从柔性泵242流到流体源170中。流体从流体源170经柔性泵242流到胃束带120中将增加胃束带120中的压力并由此减小胃140中人造口的尺寸。
虽然柔性泵242被描述为手动操作以在流体源170与胃束带120之间输送流体，但是实际上柔性泵242不必将来自流体源170的流体输送到胃束带120中。换言之，胃束带120中的压力可通过仅仅使流体从流体源170向着胃束带120移动(例如通过从流体源170向柔性泵170泵送流体，这使之前在柔性泵170中的流体移动到胃束带120中)而增加，这样这种移动可引起流体源170的流体“上游”的类似的移动。对于通过触摸柔性泵242将流体引入到胃束带120中来说，实际上不需要流体来自流体源170。这种额外的流体可来自胃束带120与流体源170之间的系统100的任何部分。此外，如上所述，流体源170可具有各种构造，并且系统100可包括任意数目的流体源。
柔性泵242可以任意次数并以任何频率被致动(步骤252)。例如，系统100可被植入到患者体内，并且流体源170至少部分填充。植入之后，胃束带120可被充满流体，诸如通过致动柔性泵242和/或通过医生(或者其他医务人员)使用针和注射器通过注射端口130引入流体(步骤252)。患者的治疗计划可包括规定或者推荐次数的柔性泵致动(例如每天、每小时、每周、每月等等)以及每次致动的任意下压次数(例如一次、两次等)。规定或者推荐次数的柔性泵致动对于不同患者是变化的，甚至对于单个患者来说也可以由于患者体重降低或者可影响患者的治疗计划的其他经历而变化。具有这样的泵送时间表或者制度可帮助调节在胃束带120中由于患者体重降低可发生的任何压力损失。但是，如果患者忽略规定、推荐或者其他需要致动柔性泵242(步骤252)，系统100可保持功能性，并且胃束带120中的压力大致按指数压力下降(例如下面讨论的图11中的序列250)。
如上所述，系统还可包括如果胃束带120中的压力超过最大阈值压力则从胃束带120释放流体的第二阀246或者其他释放机构。第二阀246通常具有两个位置，即防止流体流过其中的关闭位置和允许流体沿着单方向从其中流过的打开位置(例如流出胃束带120)。第二阀的缺省位置是关闭的，使向着胃束带120流动的任何流体流进胃束带120中并且不进入第二阀246中。但是，第二阀246可确定胃束带120中的流体是否大于预设压力限(步骤258)。如果没有，则第二阀246处于关闭位置(或者从打开位置运动到关闭位置)，以便允许流体流进胃束带120中(步骤260)。如果超过预设压力限，则第二阀246可运动到打开位置，以便允许流体流进胃束带120中(步骤262)。
第二阀246可以各种方式控制流体流动。第二阀246可被用于这样控制流体流动的系统的例子在前述美国专利申请公开No.2005/0272968中以及前述与本发明同一天提交的名称为“FluidLogic for Regulating Restriction Devices”(代理卷号：No.100873-220(END6278))的美国专利申请中详细公开。第二阀246实际上可具有有效地控制流体流动的任何构造，但在一些示例性实施方式中第二阀246具有预设压力限或者预设压力范围，第二阀246依靠预设压力限或者预设压力范围使胃束带120中达到所需压力。第二阀246可因此而控制加入到胃束带120和/或从胃束带120中除去的流体量，从而控制由胃束带120形成的限制大小。
第二阀246可具有最大预设压力限，当胃束带120中的流体的压力超过最大预设压力限时(由于食物堵塞通路，过多次触摸柔性泵242等)，使流体从胃束带120中被释放(进入流体源170(如果第二阀246与流体源联接)或者体内另一流体释放位置)，从而降低胃束带120中的压力(从而降低限制大小)，直到压力等于或小于最大预设压力限。具有预设压力限特别有利的是，因为其允许胃束带120中压力的少量变化(例如在患者正进食时)，而不需要连续改变胃束带120中的流体压力，而且其有效地将压力保持在所需范围，以便为使胃束带120有效而提供必须的限制大小。
第一阀244还可被构造成具有锁定位置和打开位置。锁定位置和打开位置通常分别对应于上面讨论的用于第二阀246的关闭和打开位置，从而使流体可在打开位置(步骤264)中流经第一阀244(步骤266)，但在锁定位置不流经第一阀244。虽然第二阀246在关闭位置和打开位置之间切换基本上可以是自动的，但在一些实施方式中第一阀244可被构造成从锁定位置手动释放到打开位置，反之亦然，该第一阀244可被构造成从打开位置手动运动到锁定位置。
第一阀244可在锁定和打开位置之间以各种方式手动切换。可在锁定位置和打开位置之间切换的第一阀244的例子在前述美国专利申请公开No.2005/0272968中详细公开。一般说来，第一阀244可防止在没有医生(或者其他医务人员)授权的情况下在锁定位置和打开位置之间的手动切换，无论患者还是另外的人进行手动切换，诸如在急救或者异常情况下当第一阀244由于流体应当从胃束带120中被释放而应当被打开时，例如由于胃束带120中的折叠、患者不适、第二阀246的预设压力限逻辑故障等等。
例如，第一阀244可包括机械锁定元件，以便允许第一阀244在锁定位置和打开位置之间手动切换。用于第一阀244的机械锁定元件的一种实施方式包括响应于手动触摸的机构。仅仅作为例子，第一阀244可被构造成使得第一阀244的构型可通过开关、杆、拨盘、按钮或者任何其他合适的切换替代或者它们的组合经皮操作在锁定位置和打开位置之间切换。在第一阀244的构型可由这样的一个或多个机构手动切换时，第一阀244可基于一个或多个切换机构的位置给出指示第一阀244构型的触觉反馈。此外，可要求一系列一次或多次经皮操作，以便在锁定位置和打开位置之间切换第一阀244，例如以指定顺序压下机械元件。患者可被要求看医生(或者其他授权医务人员)来接收正确的系列经皮操作，从而使医生知道和/或授权流体调节。
用于第一阀244的机械锁定元件的另一种实施方式包括响应于磁场的机构。仅仅作为例子，第一阀244可包括磁体阵列。当特定磁性“键”设置在第一阀244附近时，第一阀244可在锁定位置和和打开位置之间切换。“键”可以是隐藏的并仅仅由医生(或者其他授权医务人员)为患者提供或揭示。
第一阀244如何在锁定位置和打开位置之间手动切换的另一个例子包括非电磁能经皮传递到第一阀244。仅仅作为例子，第一阀244可被构造成使第一阀244可通过超声在锁定位置和打开位置之间被切换。换言之，第一阀244可对超声产生响应，使第一阀244可被通过机械式共振和/或由超声产生的其他效应致动或者置于各种构型。
第一阀244可被制成对超声的不同频率产生不同响应。例如，第一频率可致动第一阀244中的第一阀门或者将第一阀244设置在打开位置，使流体被允许流出胃束带120，而流体从流体源170向着胃束带120的流动则被防止。第二频率可致动第一阀244中的第二阀门或者将第一阀244设置在锁定位置，使流体被防止通过第一阀244流进胃束带120中。第一阀244可被构造成使第一阀244通过缺省而处于锁定位置(例如当其没有正被暴露于超声的第一频率下时)。在这样的实施方式中，第一阀244对第一频率的响应可大体上暂时被限制成第一阀244暴露于第一频率的持续时间。换言之，第一阀244可被构造成使第一阀244仅仅在其暴露于第一频率的大致时间段内可设置在打开位置中。
作为替代，可通过超声频率的宽范围进行调节，这取决于超声能量的强度需足以避免无意中造成的启动。即使是使短暂暴露于超声能量，诸如用于不是有意进行调节的医疗诊断手术中，将基本值控制与泵送集成在一起可保证流体压力的保持。超声能量可辅助克服例如在能够使泵送发生的柔性泵242的动态密封件中的阻止运动的静态摩擦。
在这种超声启动的第一阀244中，调节的方向可通过使柔性泵242包括两个平行的泵(例如单向阀)来控制，当处于未致动状态时每个平行泵被控制以允许流体沿着每个都与所有相反的方向流动。第二阀246可以类似地被构造。因此，超声启动避免了柔性泵242因无意造成的致动，特别是不需要使用专用超声源。
作为另一个例子，如图10所示，电动阀控制器270可由来自超声发射器274的超声频率提供能量或者致动，诸如使用振荡换能器268，并且电动阀控制器270可响应于供能或致动而以机电方式致动一个或多个阀，或者响应于超声频率改变第一阀244的构型。在该实施方式中，第一阀244可与这样的换能器268和阀控制器270联接或者包括这样的换能器268和阀控制器270，并带有作为一个或多个阀的电源的电池272。由于仅仅为一个或多个阀供电，这样电池272可具有比为泵供电的电池更长的寿命，诸如在传统经皮能量传递(TET)操作的植入系统中的那些电池。另外，第一阀244，包括换能器268、控制器270和电池272，都可被电屏蔽以避免典型地附属于传统TET系统的电磁干扰控制(EMIC)考虑。
对于第一阀244对超声产生响应的任何实施方式，可能需要限制第一阀244对一些超声模式的响应。也就是说，与立即对某一或者一些超声频率产生响应不同，第一阀244可被制成使第一阀244将仅仅对在某一或者一些模式下被发射的一种或多种超声频率产生响应。仅仅作为例子，这种以模式为基础的要求可消除对第一阀244会对不可预见的超声源发射的超声产生响应的担心。
不管是否被构造成在锁定位置和打开位置之间手动切换的构造，第一阀244(和/或用于第一阀244在锁定位置和打开位置之间手动切换的控制器)可被定位于在没有帮助的情况下患者难以接近的患者解剖结构的区域上，例如在患者背部上。这样，可防止患者从胃束带120手动释放流体，并因此避免了在没有帮助和/或合适的医学授权的情况下胃束带120的压力下降。
作为非限制性的例子，图11显示了胃束带120中的经时压力测量值的示例序列248。图11中显示的压力值和时间仅仅作为例子；该压力值可包括任何时间段的任何值或者值的范围。本领域技术人员将会理解，压力测量值可包括由感测装置(例如压力读取装置134)收集的感测数据值。此外，压力设定值Pset(通常为胃束带120中的最大压力量)和压力补充值Pfill(通常为胃束带中的最小压力量，在该数值处期望或需要流体被填充到包括胃束带120的系统100中)中的一个或者两个可都经时变化，例如由于患者增加或者减少体重。图11中显示了压力测量值的另一个序列250的例子，该序列250对应于压力从Pset到Pfill的指数下降，表明恒定压力特征，例如，在0时刻与当序列250中的压力达到Pfill时的时刻tF之间柔性泵242没有工作来增加胃束带120中的流体量的可能压力特征。虽然图11的图参照图8中包括的元件进行讨论，但本领域技术人员也将会理解，该图或者类似图可使用这种或者类似控制机构160得到。
如图所示在压力序列248中，胃束带120中的压力在0时刻以Psct开始并经时下降。胃束带120中的压力可由于一种或多种因素而下降，诸如患者解剖结构的变化(例如由于体重下降)、进食、当第一阀244和/或第二阀246打开(自动或者手动)时、当胃束带故障时等等。当泵242诸如在时刻tA1和tA2被致动，压力由于流体流动到胃束带120中而增加。胃束带120中的压力还可由于其他因素而增加，诸如患者解剖结构的变化(例如由于体重增加)、进食、流体引入到系统100中、胃束带故障等等。如果胃束带120中的压力诸如在时刻tV1增加到Pset，胃束带压力已经达到预设压力限，并且第二阀246可打开并允许流体流出胃束带120。第二阀246可保持打开直到胃束带120中的压力在时刻tV2下降到Pset，在该时刻第二阀246可关闭。
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计成在单次使用后被处理，或者它们可被涉及成多次使用。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，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得到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，得到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，器械可被放置在封闭的密封容器中，诸如塑料袋或高密度聚乙烯合成纸袋。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。
优选的是装置被灭菌。这可通过本领域技术人员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 (6)
1.一种在患者体内形成限制的系统，包括：
被构造成在通路中形成限制的限制装置；
被构造成在流体源和所述限制装置之间泵送流体的泵送机构；
被构造成储存位能的能量储存机构；
与所述泵送机构和所述能量储存机构联接的能量释放机构，该能量释放机构被构造成释放所述能量储存机构存储的位能以致动所述泵送机构，使得所述泵送机构在流体源与所述限制装置之间泵送流体；
能量补充机构，该能量补充机构与所述能量储存机构联接，并被构造成接收能量并且将接收的能量传递给所述能量储存机构，
其中所述能量储存机构和能量补充机构彼此流体连通，并且通过将流体从所述能量补充机构输送到所述能量储存机构中使能量从所述能量补充机构释放到所述能量储存机构中。
2.如权利要求1所述的系统，其中将流体泵送到所述限制装置中有效地增加由所述限制装置形成的限制大小。
3.如权利要求1所述的系统，其中所述能量补充机构被构造成接收来自不与所述限制装置流体连通的第二流体源的流体。
4.如权利要求1所述的系统，其中所述能量补充机构被构造成接收被施加的动能，所述动能通过体内植入所述能量补充机构的患者的运动而获得。
5.如权利要求1所述的系统，其中所述能量储存机构被构造成接收能量，所述能量通过体内植入所述能量补充机构的患者的运动而获得的动能转化而来。
6.如权利要求1所述的系统，其中所述能量释放机构被构造成使用齿轮传动系统致动所述泵送机构。
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| Application Number | Priority Date | Filing Date | Title |
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| US11/965,331 US8142452B2 (en) | 2007-12-27 | 2007-12-27 | Controlling pressure in adjustable restriction devices |
| US11/965,331 | 2007-12-27 |
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| Publication Number | Publication Date |
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| CN101467923A CN101467923A (zh) | 2009-07-01 |
| CN101467923B true CN101467923B (zh) | 2012-07-04 |
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| CN2008101893164A Expired - Fee Related CN101467923B (zh) | 2007-12-27 | 2008-12-29 | 可调节限制装置中的压力控制 |
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| US (1) | US8142452B2 (zh) |
| EP (1) | EP2074972B1 (zh) |
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-
2007
- 2007-12-27 US US11/965,331 patent/US8142452B2/en not_active Expired - Fee Related
-
2008
- 2008-12-19 JP JP2008323387A patent/JP5425456B2/ja not_active Expired - Fee Related
- 2008-12-24 EP EP08254160.8A patent/EP2074972B1/en not_active Not-in-force
- 2008-12-29 CN CN2008101893164A patent/CN101467923B/zh not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP2074972B1 (en) | 2013-05-22 |
| EP2074972A3 (en) | 2009-08-26 |
| US8142452B2 (en) | 2012-03-27 |
| EP2074972A2 (en) | 2009-07-01 |
| US20090171375A1 (en) | 2009-07-02 |
| CN101467923A (zh) | 2009-07-01 |
| JP2009165821A (ja) | 2009-07-30 |
| JP5425456B2 (ja) | 2014-02-26 |
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