CN1839765A - 用于可调整限制装置中流体压力的无创测量的装置 - Google Patents

用于可调整限制装置中流体压力的无创测量的装置 Download PDF

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CN1839765A
CN1839765A CNA2006100582243A CN200610058224A CN1839765A CN 1839765 A CN1839765 A CN 1839765A CN A2006100582243 A CNA2006100582243 A CN A2006100582243A CN 200610058224 A CN200610058224 A CN 200610058224A CN 1839765 A CN1839765 A CN 1839765A
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小威廉·L·哈斯勒
拉塞尔·L·霍尔斯契尔
劳伦·S·佩里
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Ethicon Endo Surgery Inc
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Abstract

一种用于在患者体内形成限制并且将关于所述限制的压力数据无创地传递给外部监视器的限制系统，例如可调整束胃带。所述系统包括用于植入到患者体内以形成限制的限制装置。所述系统进一步包括连接到所述限制装置的植入端口。所述端口包含用于影响所述限制的尺寸工作流体。所述系统进一步包括与所述工作流体相通讯的压力检测系统，该压力检测系统用于测量所述工作流体的压力和将压力测量数据发送到外部监视器。

Description

用于可调整限制装置中流体压力的无创测量的装置
技术领域
本发明总的涉及可植入限制装置，尤其涉及充有流体的限制装置。本发明甚至进一步涉及用于治疗病态肥胖症的摄食限制装置。
背景技术
尤其在美国，由于肥胖者的数量持续增长，并且肥胖症的负面健康影响被更多地了解，肥胖症正日益受到关注。病态肥胖症(其中人的体重超出理想体重100磅或以上)尤其造成了严重健康问题的重大风险。因此，相当多的注意力正集中到对肥胖患者的治疗上。治疗病态肥胖症的一种方法是围绕胃的上部放置限制装置，例如细长束带。所述束带被放置成在所述束带之上形成小胃袋并且在胃中形成减小的人造口。所述束带的作用是减小可利用的胃容积，由此在“饱”之前减小可消耗的食物量。束胃带通常包括充有流体的弹性囊，该弹性囊束带有恰在食道-胃连接处下方环绕胃的固定端点。当流体被注入所述囊时，所述束带相对胃膨胀，在胃中产生摄食限制或人造口。为了减小该限制，从所述束带去除流体。
食物限制装置也包括类似地环绕胃的上部的可以机械方式调整的束带。这些束带包括任何数量的弹性材料或传动装置以及驱动构件，以用于调整所述束带。另外，束胃带已经发展成同时包括液压和机械驱动元件。这种可调整束胃带的例子在授权日为2000年5月30日、名称为“机械摄食限制装置”的美国专利No.6,067,991中被披露，该专利被引入作为参考。通过将可膨胀弹性囊植入到胃腔自身中而限制胃腔中的可利用食物容积也是已知的。所述囊充有流体以相对胃壁膨胀，由此减小胃中的可利用食物容积。
对于上述每一种食物限制装置，安全有效的治疗需要定期监视和调整所述装置，以改变对胃施加的限制程度。使用束带装置，在初始植入之后，所述束带之上的胃袋在尺寸上将明显地增加。因此，胃中的人造开口初始时必须被造的足够大以使患者能够接收足够的营养，同时胃要适应所述束带装置。当胃袋尺寸增加时，所述束带必须被调整以改变人造口的尺寸。另外，为了适应患者身体的变化或治疗方案，或者在更紧急的情况下，为了缓解堵塞或严重食道膨胀，需要改变人造口的尺寸。传统上，调整液压束胃带需要例行的临床医生就诊，在此期间皮下针或注射器用于穿刺患者皮肤并从所述囊加入或去除流体。更近以来，已经开发出了能够无创地调整所述束带的可植入泵。外部编程器使用遥感与所述可植入泵通信以控制所述泵。在例行就诊期间，医生将编程器的手持部分放置在胃植入物附近，并且向所述植入物发送功率和命令信号。所述植入物又调整所述束带中的流体水平并且向编程器发送响应命令。
在这些束胃带调整期间，难以确定所述调整进行得如何，以及所述调整是否将具有预期效果。为了试图确定调整的功效，一些医生在执行调整时利用了使用钡餐的荧光透视检查法。然而，荧光透视检查法不仅昂贵而且不受欢迎，因为医生和患者都招致辐射剂量。其他医生指示患者在所述调整期间或之后饮用一杯水，以确定水是否可以通过被调整的人造口。然而，该方法仅仅能保证患者不堵塞，而不能提供关于调整效果的任何信息。经常地，医生根据他们以往的经验简单地采用“try as you go”的方法，可能直到数小时或数天之后，当患者经受到胃腔的完全堵塞时，或者所述束带引起胃组织糜烂时，调整的结果才被发现。
因此，需要提供一种在调整期间或即刻之后用于评估摄食限制装置的调整的有效方法。尤其是，需要提供一种胃限制装置，其包括用于测量所述限制装置内的压力并因而测量人造口尺寸的压力测量系统。另外，需要提供一种用于在调整期间测量流体压力和将所述压力测量值传递给外部监视器的无创方法。
发明内容
根据本发明，提供了一种用于在患者体内形成限制并且将关于所述限制的压力数据无创地传递给外部监视器的限制系统，例如可调整束胃带。所述系统包括植入到患者体内以形成限制的限制装置。所述系统进一步包括连接到所述限制装置的植入端口。所述端口包含用于影响所述限制的尺寸的工作流体。所述系统进一步包括与所述工作流体相联系的压力检测系统，该压力检测系统用于测量所述工作流体的压力和将压力测量数据发送到外部监视器。
(1)本发明涉及一种用于在患者体内形成限制并且将关于所述限制的压力数据无创地传递给外部监视器的限制系统，所述系统包括：a.用于植入到患者体内以在其中形成限制的限制装置；b.连接到所述限制装置的植入端口，所述端口包含用于影响所述限制的尺寸的工作流体；以及c.与所述工作流体相通讯的压力检测系统，该压力检测系统用于测量所述工作流体的压力并将压力测量数据发送到外部监视器。
(2)根据第(1)项所述的限制系统，其中，所述工作流体的压力与形成限制的程度成比例。
(3)根据第(2)项所述的限制系统，其中，所述压力检测系统包括与所述工作流体接触的可机械变形的表面，并且所述表面与所述工作流体的压力成比例地变形。
(4)根据第(3)项所述的限制系统，其中，所述可机械变形的表面在其上具有机械变形，所述机械变形被转换成指示所述工作流体内压力的电信号。
(5)根据第(4)项所述的限制系统，其中，所述压力检测系统包括连接到所述可变形表面上的两个或以上的可变电阻元件，所述元件的电阻响应所述表面的机械变形而变化；并且所述电阻元件被连接在电路中，所述电路的输出提供所述工作流体压力的测量值。
(6)根据第(1)项所述的限制系统，其中，所述限制装置是可调整的束胃带。
(7)根据第(4)项所述的限制系统，其中，所述压力检测系统包括可变电容电容器，所述电容器的电容响应所述工作流体中的压力变化而改变，所述电容的变化提供所述工作流体压力的测量值。
(8)根据第(4)项所述的限制系统，其中，所述工作流体可在所述端口和所述限制装置之间在封闭流体回路中传递，以影响所述限制的尺寸。
(9)根据第(4)项所述的限制系统，其中，在所述限制装置的调整期间，所述压力检测系统测量所述工作流体压力，并且将所述压力测量数据发送到所述外部监视器。
(10)根据第(4)项所述的限制系统，其中，所述压力检测系统包括邻近所述可变形表面的可变感应线圈，所述线圈的感应响应所述工作流体中的压力变化而改变，所述电感的变化提供所述工作流体压力的测量值。
(11)本发明还涉及一种用于在患者体内形成限制并且将关于所述限制的压力数据无创地传递给外部监视器的限制系统，所述系统包括：a.用于植入到患者体内以在其中形成限制的限制装置，所述限制构件具有用于形成限制的可变流体容积；b.可操作地连接到所述限制构件以用于改变所述限制构件的容积的控制器；以及c.用于测量所述限制构件内的流体压力并无创地将所测量的压力传递到所述外部监视器的压力检测系统，所测量的压力与在胃中形成的限制的程度成比例。
(12)根据第(11)项所述的限制系统，其中，所述压力检测系统包括与所述工作流体接触的可机械变形的表面，所述表面的变形与所述工作流体的压力成比例。
(13)根据第(12)项所述的限制系统，其中，所述可机械变形的表面在其上具有机械变形，所述机械变形被转换成指示所述工作流体内压力的电信号。
(14)根据第(13)项所述的限制系统，其中，所述压力检测系统包括连接到所述可变形表面上的两个或以上的可变电阻元件，所述元件的电阻响应所述表面的机械变形而变化；并且所述电阻元件被连接在电路中，所述电路的输出提供所述工作流体压力的测量值。
(15)根据第(11)项所述的限制系统，其中，所述限制装置是可调整的束胃带。
(16)根据第(13)项所述的限制系统，其中，所述压力检测系统包括可变电容电容器，所述电容器的电容响应所述工作流体中的压力变化而改变，所述电容的变化提供所述工作流体压力的测量值。
(17)根据第(13)项所述的限制系统，其中，所述工作流体可在所述端口和所述限制装置之间在封闭流体回路中传递，以影响所述限制的尺寸。
(18)根据第(13)项所述的限制系统，其中，在所述限制装置的调整期间，所述压力检测系统测量所述工作流体压力并且将所述压力测量数据发送到所述外部监视器。
(19)根据第(13)项所述的限制系统，其中，所述压力检测系统包括邻近所述可变形表面的可变感应线圈，所述线圈的感应响应所述工作流体中的压力变化而改变，所述感应的变化提供所述工作流体压力的测量值。
附图说明
图1是本发明的摄食限制装置的示意图；
图2是用于图1的摄食限制装置的一个示例性的可植入部分的更详细的透视图；
图3是图2的可调整束胃带的透视图，其显示了围绕患者的食道-胃连接处定位的束带；
图4是图2的可调整束胃带的剖视图，其被显示成收缩构造；
图5是图2的可调整束胃带的剖视图，其被显示成膨胀构造以形成摄食限制；
图6是图2中所示的注射端口的侧面局部剖视图；
图7是图6中所示的保持盖的等轴测图；
图8是图6中所示的压力传感器的等轴测图；
图9是显示本发明的压力检测系统的第一实施例的侧面剖视图；
图10是第一实施例的变阻电路的简化示意图；
图11是本发明的压力检测系统的第二实施例的侧面剖视图；
图12是表示与本发明的第一和第二实施例相关联的压力测量系统的方框图；
图13是本发明的压力检测系统的第三实施例的侧面剖视图；
图14是表示与本发明的第三实施例相关联的压力测量系统的方框图；
图15是本发明的压力检测系统的第四实施例的侧面剖视图；
图16是本发明的压力检测系统的第五实施例的侧面剖视图；
图17是与本发明的第四和第五实施例相关联的压力测量系统的方框图；以及
图18是表示来自压力测量系统的压力信号图，例如可以在用户询问期间显示在外部监视器上。
具体实施方式
现在具体参考附图，其中在所有视图中相同的附图标记表示相同的元件，图1示出了摄食限制系统30。系统30包括：通常标识为32的第一部分，其植入到患者34体内；和通常标识为36的第二部分，其位于患者体外。植入部分32包括定位在患者的胃40的上部的可调整束胃带38。可调整束带38可以包括由硅橡胶或者其它类型的生物相容材料制成的腔，当充有流体时所述腔相对胃40向内部膨胀。作为选择，束带38可以包括具有流体腔的可以机械方式调整的装置，其中所述流体腔随着束带的调整经历压力变化，或者包括组合的液压/机械式可调整束带。注射端口42，其将在下面被更详细地描述，被植入到易接近针注射和/或遥感通信信号的身体区域。在所示的实施例中，注射端口42经过导管44与可调整束带38流体地连通。外科医生可以将注射端口42定位和永久地植入到患者的身体内，以便进行摄食限制或人造口的调整。本领域的技术人员将认识到，放置诸如可植入部分32这样的束胃带系统的方法在近年来得到了极大发展，患者可以在极小并发症的情况下获得最佳的疗效。外科医生，例如，通常在患者腹部的侧面的肋下区域中将注射端口42植入到皮肤和脂肪组织层之下。外科医生也可以将注射端口42植入到患者的胸骨上。
图2更详细地示出了一个示例性可调整束胃带。在该实施例中，束带38包括可变体积腔46，该可变体积腔相对胃的外壁膨胀或收缩，以形成用于可控地限制食物摄取到胃中的可调整人造口。外科医生可以通过将流体加入到可变体积腔46中而减小人造开口的尺寸，或者通过从所述腔取出流体而增加人造口尺寸。可以通过将针插入到注射端口42中而加入或取出流体。作为另一选择，可以使用遥感命令信号以无创的方式在束带38和注射端口42之间传输流体。所述流体可以是但并不限于0.9％的盐溶液。
图3显示了围绕患者的胃-食道连接处应用的图2的可调整束胃带38。如图3中所示，束带38至少与食道48的连接处附近基本上围住胃40的上部。图4是束带38的剖视图，其显示了处于收缩构造的束带。在该视图中，束带38包含很少的流体或不包含流体，由此使胃40中的人造开口的尺寸最大化。图5是类似于图4的束带38和胃40的剖视图，其显示了处于膨胀的、充有流体的构造的束带38。在该视图中，束带38相对胃40的压力由于束带中的流体而增加，由此减小人造开口而产生摄食限制。图5还示意性地示出了束带38之上的食道48的膨胀，以在患者的膈肌52之下形成上部袋50。
仍参照图1，食物限制系统30的体外部分36包括电连接(在该实施例中通过电缆组件62)到控制箱64的压力读取装置60。控制箱64包括显示器66、一个或多个控制开关68和外部控制模块，其将在下面进一步被具体地解释。控制箱64可以被构造成例如用于门诊室或检查室中。安装控制箱64的一些方法包括放置到桌面上、固定到检查台上或悬挂在便携支架上。控制箱64也可以构造成用于携束带在医生工作服的口袋中、手持或放置在检查台上或斜躺的患者身上。电缆组件62可以可拆卸地连接到控制箱64或压力读取装置60，以便于系统30的体外部分36的清洁、维护、使用和贮存。压力读取装置60无创地测量植入部分32内流体的压力，即使当注射端口42被植入到厚(至少大于10厘米)的皮下脂肪组织之下。外科医生可以贴着靠近患者体内注射端口42的位置的患者皮肤握着压力读取装置60，并且观察控制箱64的显示器66上的压力读数。例如在延长的检查期间，压力读取装置60也可以使用固定带、粘合剂和其它公知的方法可拆卸地连接到患者身上。压力读取装置60通过传统的织物或纸质的手术单操作，并且也可以包括对于每个患者可以被替换的处理盖(未示出)。
现在参考图6，其显示了包含用于无创测量植入部分32内流体压力的压力检测系统的注射端口42的侧面局部剖视图。如图6中所示，注射端口42包括具有环形凸缘72的刚性外壳70，所述环形凸缘72包含多个用于将注射端口紧固到患者体内的组织上的连接孔74。外科医生可以使用多种外科紧固件中的一种将注射端口42连接到组织(例如覆盖腹肌的筋膜)上，所述外科紧固件包括缝线、缝钉和夹具。注射端口42进一步包括隔膜76，该隔膜通常由硅橡胶制成并且压缩地保持在外壳70中。隔膜76可由休伯针或相似类型的注射器械穿刺，以用于从所述端口加入或取出流体。当注射针缩回时隔膜76自密封以保持注射端口42内部的流体体积。注射端口42进一步包括用于保持工作流体的容器80和导管连接器82。连接器82连接到导管44，如图2中所示，以在注射端口42内部的容器80和可调整束带38内的腔46之间形成封闭的液压回路。来自容器80的流体可以用于膨胀束带腔46的体积。或者，流体可以从腔46中被去除并且保留在容器80中，以便暂时减小腔46的体积。外壳70和连接器82可以由生物相容聚合物整体地模制或者由诸如钛或不锈钢这样的金属构造。
压力检测系统设在注射端口42中以测量植入部分32的封闭液压回路内的流体压力。所述回路内的压力对应于由可调整束带38施加给患者胃的限制量。因此，测量流体压力使外科医生能够评估由束带的调整所产生的限制。流体压力可以在调整之前、期间和/或之后被测量，以验证所述束带是否被正确地调整。在图6所示的实施例中，压力检测系统包括定位在外壳70内、流体容器80的底部的传感器84。保持盖86在压力传感器84上延伸以基本上使传感器表面与容器80分开，并且保护传感器免受针刺。保持盖86可以由陶瓷材料制成，例如诸如氧化铝，其抵抗针刺穿而又不会干涉压力传感器84和压力读取装置60之间的电子通信。保持盖86包括开孔90，该开孔允许容器80内的流体流向并且撞击压力传感器84的表面。
图7是保持盖86的等轴测图，其示出了在所述盖的底面中的开孔90。图8是压力传感器84的外部的等轴测图。如图8中所示，压力传感器84的外部包括具有可变形表面的应变元件。在所示的实施例中，所述应变元件是隔膜92。隔膜92可以通过使钛容器80的壁剖面变薄而形成。隔膜92可以由钛或其它类似的材料制成，并且具有在0.001”至0.002”之间的厚度。尽管所述实施例显示了作为应变元件的隔膜，本发明也可以使用其它应变元件来构造和实施，以将流体压力转换为机械位移。其它合适的应变元件的例子包括但不限于布尔登管和波纹管组件。压力传感器84被气密密封在壳体94内以防止流体渗入和影响传感器的操作。壳件94被密封到端口外壳70上以防止流体从注射端口42处损失。隔膜92被密封到传感器外壳94以防止流体经过隔膜的边缘并且进入检测系统的内部部件中。当流体流过容器80中的开孔90时，所述流体撞击在隔膜92的表面上。通过开孔90的所述流体流使隔膜92能够响应液压回路内的流体压力变化并且将所述压力变化转换成机械位移。
图9是沿图8的线A-A得到的压力传感器84的侧剖视图，其示出了用于测量流体压力的第一实施例88。在图9所示的实施例中，隔膜92的机械位移被一对变阻硅应变计96、98转换成电信号。应变计96、98在与容器80中的工作流体相对的一侧连接到隔膜92上。应变计96连接到隔膜92的中心部分以测量隔膜的位移。第二匹配应变计98连接到隔膜92的外边缘附近。应变计96、98可以通过粘合剂连接到隔膜92，或者可以结合到隔膜结构中。当束带38内的流体压力变化时，隔膜92的表面在壳体94的表面内向上或向下变形。隔膜92的该变形导致中心应变计96中的电阻变化。
如图10中所示，应变计96、98形成半补偿惠斯通电桥电路100的顶部的两个电阻元件。当应变计96对隔膜92的机械变形起反应时，所述应变计的变化电阻改变了跨过所述电桥电路的顶部的电势。应变计98与应变计96匹配并且使所述惠斯通电桥电路绝热。差动放大器102、104连接到电桥电路100以测量由于变阻应变计而引起的所述电桥电路内的电势变化。尤其是，差动放大器102测量跨过整个电桥电路的电压，而差动放大器104测量跨过电桥电路100一半的应变计的电压差。对于跨过所述电桥的固定电压，应变计电压之间的差值越大，压力差越大。如果需要，也可以使用全补偿惠斯通电桥电路来增加压力检测系统的灵敏度和精度。在全补偿电桥电路中，四个应变计连接到隔膜92的表面，而不是如图9中所示仅有两个应变计。
来自差分放大器102、104的输出信号被应用到微控制器106。微控制器106被集成到壳体94内的电路板110中。温度传感器112测量植入端口中的温度并且将温度信号输入到微控制器106。微控制器106使用来自传感器112的温度信号来补偿体温的变化和未被应变计98计入的残余温度误差。补偿体温变化的压力测量信号增加了压力检测系统的精度。另外，TET/遥感线圈114位于壳体94内。将线圈114连接到电容116而形成调谐振荡电路，以用于从体外部分36接收功率，并且将压力测量值发送给压力读取装置60。
图11是类似于图9的侧剖视图，其显示了用于本发明的压力检测系统的第二实施例118。在第二实施例118中，将MEMS传感器120设在壳体94中以测量隔膜92的机械变形并且产生与可调整束带38内的压力成比例的电信号。密封的硅油室122设在隔膜92和MEMS传感器120之间。油室122保护MEMS传感器120并且将隔膜92的机械位移传递给所述传感器。MEMS传感器120将指示容器80内的流体压力的电信号输出到微控制器106。微控制器106输入来自MEMS传感器120的信号和来自温度传感器112的温度信号，并计算压力测量值。通过使用遥感信号经所述压力测量值发送到体外部分36中的压力读取装置60，这将在下面更具体地被描述。
图12是用于本发明的第一和第二实施例88、118的压力测量系统的方框图。如图12中所示，所述系统的外部控制模块126包括用于将功率信号发送给通常标识为132的内部控制模块的初级TET线圈130。初级TET线圈130位于图1中所示的压力读取装置60中。TET驱动电路134控制向初级TET线圈130的功率信号应用。TET驱动电路134受到具有相关存储器138的微处理器136控制。图形用户界面140连接到微处理器136以用于控制显示器66上显示的数据。外部控制模块126也包括初级遥感收发器142，该收发器用于向植入控制模块132发送询问命令和从植入控制模块132接收响应数据，包括流体压力读数。初级收发器142电连接到微处理器136以用于输入和接收命令和数据信号。初级收发器142以选定的RF通信频率共振，以产生将命令数据发送到植入控制模块132的下行链路交变磁场146。电源150向外部控制模块126供应能量，以便为系统30提供动力。环境压力传感器152连接到微处理器136。对于例如由于气压条件或海拔引起的大气压力变化，为了增加压力测量值的精度，微处理器136使用来自环境压力传感器152的信号调整压力读数。
图12还示出了植入到患者皮肤154之下的内部控制模块132。内部控制模块132位于注射端口42的壳体94内。如图12中所示，内部控制模块132中的次级TET/遥感线圈156接收来自外部控制模块126的功率和通信信号。线圈156形成振荡电路，该振荡电路与初级TET线圈130电感耦合，以为植入物供能，或与初级遥感线圈144电感耦合以接收和发送数据。遥感收发器158控制与线圈156的数据交换。另外，内部控制模块132包括：整流器/功率调节器160、上述的微控制器106、与所述微控制器相关联的存储器162、温度传感器112、压力传感器84和用于放大来自所述压力传感器的信号的信号调节电路164。内部控制模块132将来自压力传感器84的温度调节压力测量值发送到外部控制模块126。在外部模块126中，接收的压力测量信号因环境压力的变化而被调节并且显示在显示器66上。
图13是显示根据本发明的用于测量流体压力的第三实施例170的侧剖视图。在第三实施例170中，内部控制模块132例如由诸如电池172这样的内部电源提供动力。电池172代替初级和次级TET线圈130、156来为微控制器106和其它内部部件提供动力。在该实施例中，压力检测系统包括如第一实施例88中的一对应变计96、98，以用于测量对应于束带38中的压力变化的隔膜92的机械变形。应变计96、98被结合到平衡的热补偿电桥电路中，以用于测量植入物的封闭流体回路内的压力差。
图14是根据图13中所示的第三实施例170的本发明的压力测量系统的方框图。在实施例170中，内部电源用于为内部控制模块176提供动力而非如第一实施例中的TET功力系统。用于植入部分32的电源是电池172而不是图12中所示的TET初级线圈130和次级线圈156。在图14所示的实施例中，次级植入线圈156单独地用于内部和外部控制模块之间的数据通信。为了保存和延长电池的寿命，提供功率调节器174以控制来自电池172的功率。
图15示出了用于测量可调整束带38内的流体压力的第四实施例180，其中利用无源系统来测量工作流体内的压力变化。在该第四实施例180中，可变电容182连接到隔膜92，以便测量隔膜的机械变形。可变电容182包括在与流体容器80相对的一侧上靠近隔膜92的中心连接的第一板184。第二电容器板186由电容器固定件188固定在壳体94中的适当位置。电容器板184、186中的每一个都连接到感应线圈190，如线192所示，以形成谐振电路。当容器80内的流体压力例如由于相对束带38的蠕动压力变化而增加或减小时，电容器板184的位置随着隔膜92的变形而变化。当流体压力增加时，隔膜92推动第一电容器板184更靠近第二电容器板186，由此增加电容并减小谐振频率。类似地，当液压在封闭植入回路中减小时，第一电容器板184与隔膜92一起朝着远离第二板186的方向运动，由此减小谐振电路中的电容并增加谐振频率。
图16显示了根据本发明用于测量流体压力的第五实施例196。第五实施例196是用于无源压力检测系统的一个可选实施例，其中可变感应线圈200将隔膜92的机械变形转换成压力测量信号。如图16中所示，感应线圈200是放置在隔膜92下方的扁平线圈。将固定电容202连接到感应线圈200，如线204所示，以形成LC谐振电路206。当隔膜92响应工作流体的压力变化而向上和向下变形时，线圈200的感应变化。当流体压力增加时，隔膜92朝线圈200的方向变形，由于金属隔膜和线圈之间的涡流耦合，因此减小了线圈200的感应。相反地，当流体压力减小时，隔膜92远离线圈200变形，由此减小了涡流耦合并增加了线圈的感应。因此，线圈200的感应与工作流体的压力成反比。当线圈200的感应变化时，LC电路206的谐振频率发生变化。
图17是用于本发明的第四和第五实施例180、196的压力测量系统的方框图。在该系统中，微处理器136控制感应线圈电路208和施感线圈210。微处理器136改变施感线圈210的频率，以使所述线圈和植入部分32中的LC电路206磁耦合，如线212所示。内部和外部线圈耦合的频率将随着植入的LC电路206的谐振频率而变化。植入的LC电路的谐振频率将随着束带38内的流体压力而变化。谐振频率的变化通过施感线圈电路208由微处理器136测量。一旦被测出，谐振频率可以与在指定频率的已知压力相比较，以确定束带38内的流体压力。内部模块214中的图形用户界面140在显示器66上显示测量的流体压力。
图18是来自本发明的压力检测系统的压力信号216的图形表示，例如可以在用户询问期间显示在显示器66上。在图18中所示的例子中，当患者稳定时，流体压力初始由压力读取装置60测量，从而得到所示的稳定的压力读数。接着，对束带38进行调整以减小人造口尺寸。在束带的调整期间，压力检测系统继续测量流体压力并且将压力读数通过患者的皮肤发送到装置60。从图18的线可以看出，压力读数在束带调整之后略微上升。在所示的例子中，患者然后被要求饮用液体以检查调整的精度。当患者饮用时，压力检测系统继续测量由于吞饮液体的蠕动压力而导致的压力测试信号，并且将压力读数发送到外部模块36以用于显示。在调整期间和之后通过测量和可视地显示对胃蠕动的限制装置的负荷，本发明为外科医生提供了患者响应所述调节的精确的、实时的显示。记录的压力数据的该瞬时的有效显示使外科医生能够执行更精确的束带调整。所述数据可以随着时间被显示，以提供随时间的压力变化。
除了在调整期间使用外，本发明的压力检测系统也可以用于在治疗期间的各个间期测量限制装置的压力变化。周期压力读数使压力检测系统能够起到诊断工具的作用，以确保摄食限制装置正在有效地工作。尤其是，所述压力检测系统可以用于检测以在所述束带内没有压力的状况，指示流体泄漏。或者，所述系统可以用于检测在所述束带内的过度压力检测信号，以指示导管44的纽结或人造口内的堵塞。
本发明的压力检测系统也使患者能够在家中通过利用诸如外部装置36这样的外部监视器来跟踪他们自身的治疗。使用外部装置，患者可以例行地将压力读数下载到他们的外科医生的诊所，由此减小监视患者的治疗所需要的门诊次数。另外，患者可以在家中进行压力读数并且当束带压力下降到表示需要调整所述装置的特定基线以下时通知他们的外科医生。本发明的压力检测系统因而在使用肥胖症治疗装置的患者治疗期间作为诊断和监视工具是有利的。
对于那些本领域的技术人员来说，上述发明可同等地适用于其它类型的可植入束带将是显而易见的。例如，束带可用于大便失禁的治疗。在美国专利6,461,292中描述了这样的一种束带，该专利被援引于此以作参考。束带也可以用于治疗尿失禁。在美国专利申请2003/0105385中描述了这样的一种束带，该申请被援引于此以作参考。束带也可以用于治疗胃灼热和/或酸反流。在美国专利6,470,892中描述了这样的一种束带，该专利被援引于此以作参考。束带也可以用于治疗阳痿。在美国专利申请2003/0114729中描述了这样的一种束带，该申请被援引于此以作参考。
尽管本发明通过几个实施例的描述举例说明了本发明，申请人的目的并不是要将后附的权利要求的精神和范围约束或限制在这样的细节。在不脱离本发明的范围的情况下，本领域的技术人员可以进行多种其它的变化、改变和替换。例如，本发明的装置和方法已经被描述成涉及在注射端口内提供压力传感器。作为另一选择，为了测量所述束带内的压力变化，所述传感器可以定位在所述束带的充有流体的部分中。另外，所述压力传感器可以与植入到胃腔中的弹性囊相关联，以测量所述囊内的流体压力。与本发明相关联的每个元件的结构可被描述成用于提供由所述元件执行的功能的部件。应当理解，前面的描述仅仅作为例子而提供，在不脱离后附的权利要求的范围和精神的情况下，本领域的技术人员可以进行其它修改。

Claims (10)

1.一种用于在患者体内形成限制并且将关于所述限制的压力数据无创地传递给外部监视器的限制系统，所述系统包括：
a.用于植入到患者体内以在其中形成限制的限制装置；
b.连接到所述限制装置的植入端口，所述端口包含用于影响所述限制的尺寸的工作流体；以及
c.与所述工作流体相通讯的压力检测系统，该压力检测系统用于测量所述工作流体的压力并将压力测量数据发送到外部监视器。
2.根据权利要求1所述的限制系统，其特征在于，所述工作流体的压力与形成限制的程度成比例。
3.根据权利要求2所述的限制系统，其特征在于，所述压力检测系统包括与所述工作流体接触的可机械变形的表面，并且所述表面与所述工作流体的压力成比例地变形。
4.根据权利要求3所述的限制系统，其特征在于，所述可机械变形的表面在其上具有机械变形，所述机械变形被转换成指示所述工作流体内压力的电信号。
5.根据权利要求4所述的限制系统，其特征在于，所述压力检测系统包括连接到所述可变形表面上的两个或以上的可变电阻元件，所述元件的电阻响应所述表面的机械变形而变化；并且所述电阻元件被连接在电路中，所述电路的输出提供所述工作流体压力的测量值。
6.根据权利要求1所述的限制系统，其特征在于，所述限制装置是可调整的束胃带。
7.根据权利要求4所述的限制系统，其特征在于，所述压力检测系统包括可变电容电容器，所述电容器的电容响应所述工作流体中的压力变化而改变，所述电容的变化提供所述工作流体压力的测量值。
8.根据权利要求4所述的限制系统，其特征在于，所述工作流体可在所述端口和所述限制装置之间在封闭流体回路中传递，以影响所述限制的尺寸。
9.根据权利要求4所述的限制系统，其特征在于，在所述限制装置的调整期间，所述压力检测系统测量所述工作流体压力，并且将所述压力测量数据发送到所述外部监视器。
10.根据权利要求4所述的限制系统，其特征在于，所述压力检测系统包括邻近所述可变形表面的可变感应线圈，所述线圈的感应响应所述工作流体中的压力变化而改变，所述电感的变化提供所述工作流体压力的测量值。
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RU2006105524A (ru) 2007-09-10
CA2537562A1 (en) 2006-08-24
US20060189888A1 (en) 2006-08-24
EP2305174B1 (en) 2013-01-02
JP4841968B2 (ja) 2011-12-21
EP1704833A2 (en) 2006-09-27
ATE504259T1 (de) 2011-04-15
CN100539956C (zh) 2009-09-16
EP1704833B1 (en) 2011-04-06
HK1092349A1 (en) 2007-02-09
DE602006021090D1 (de) 2011-05-19
US20060199997A1 (en) 2006-09-07
BRPI0600550A (pt) 2006-10-17

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