CN101485598B - 可调节高度的胃限制装置和方法 - Google Patents

可调节高度的胃限制装置和方法 Download PDF

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CN101485598B
CN101485598B CN2008101909726A CN200810190972A CN101485598B CN 101485598 B CN101485598 B CN 101485598B CN 2008101909726 A CN2008101909726 A CN 2008101909726A CN 200810190972 A CN200810190972 A CN 200810190972A CN 101485598 B CN101485598 B CN 101485598B
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CN101485598A (zh
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A·L·马科特
D·克鲁玛纳克尔
K·费尔德
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Ethicon Endo Surgery Inc
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    • 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
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    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0056—Gastric bands remotely adjustable using injection ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223—Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0229—Subcutaneous access sites for injecting or removing fluids having means for facilitating assembling, e.g. snap-fit housing or modular design

Abstract

本发明公开了用于调节胃限制系统中的装置的高度的方法和装置。通常，该方法和装置允许连接到可植入的限制装置的一个或多个可植入的外壳具有可调节的高度。外壳可以包括，例如填充端口外壳、传感器外壳、以及任何其它类型的外壳，其可用于可植入的限制系统中并且期望具有可调节的高度。例如随着患者体重减轻，该外壳可以随着时间降低轮廓，从而将外壳维持在通常可预测的位置，在该位置可以发现并接近外壳。

Description

可调节高度的胃限制装置和方法
技术领域
本发明涉及用于调节胃限制系统中的装置的高度的装置和方法。
背景技术
肥胖越来越受到人们关注，特别是在美国，由于肥胖者数量持续增加，肥胖对健康的负面影响逐渐被人们了解。病态肥胖，人们的体重超过理想体重100磅或更多的病态肥胖尤其导致患有严重健康问题的重大风险。因此，大量注意力集中在治疗肥胖患者上。一种治疗病态肥胖的方法是围绕胃的上部放置例如为细长带的限制装置。胃束带通常包括具有固定端点且充有流体的弹性囊，该囊紧邻在食道和胃的结合部下方环绕胃，从而在带的上方形成小胃袋并且在胃中形成减小的人造口开口。当流体注入囊后，束带抵靠着胃膨胀，产生了食物入口限制或胃中的人造口。为减小该限制，将流体从束带中移除。该束带的作用是减小胃的可用容积，因此减小在吃“饱”前可以被摄入的食物量。
食物限制装置还包括机械调节的带，其类似地环绕在胃的上部。这些带包括任何数量的弹性材料或传动装置以及驱动构件，用于调节带。此外，已经开发的胃束带包括液压和机械驱动元件。在2000年5月30日授权的题为“Mechanical Food Intake Restriction Device”的美国专利No.6,067,991中已经公开了这种可调节的胃束带的例子，该美国专利通过引用合并在此。还已知的是通过将可膨胀的弹性囊植入胃腔内来限制胃腔内可用的食物容量。将囊充满流体以抵靠胃壁膨胀，并且由此减小胃内可用的食物容量。
利用上述每一种食物限制装置进行安全、有效的治疗需要定期监测和调节该装置，以改变对胃的限制程度。利用束带装置，束带上方的胃袋在最初植入后明显地增大尺寸。相应地，胃中的人造口开口初始必须做的足够大，以使患者在胃适应束带装置的同时能摄取足够的营养。随着胃袋尺寸增大，可以调节束带以改变人造口的尺寸。此外，还希望改变人造口尺寸以适应患者身体或治疗状况的改变，或者在更紧急的情况下，减轻阻塞或严重的食道扩张症。传统上，调节液压胃束带要求预约就诊，在就诊期间使用皮下注射针头和注射器穿过患者的皮肤，并且增加囊中的流体或从囊中移除流体。近来，已经开发了可植入泵，其能够非侵入式地调节束带。外部程序装置与植入泵利用遥测技术进行通信来控制泵。在预定的就诊期间，医生将程序装置的手持部分靠近胃的植入物，并且传递动力和控制信号给植入物。植入物继而调节带中的流体水平，并且传递响应指令给程序装置。
在这些胃束带调节期间，难以确定如何进行调节，并且难以确定调节是否将带来想要的效果。在试图确定调节效果中，一些医生在执行调节时利用钡吞咽透视检查。然而，透视检查既是昂贵的，并且由于医生和患者承受辐射剂量又是不期望的。其他医生嘱咐患者在调节期间或在调节之后喝一杯水，以便确定水是否能够通过被调节的人造口。然而，该方法只确保患者没有梗阻，而不能提供关于调节效果的任何信息。经常地，医生可以基于他们之前的经验简单地采用“尽可能尝试”的方法，并且只能在几小时或几天后，当患者经历胃腔的完全梗阻或带引发胃组织的糜烂时才可以得到调节的结果。
此外，胃束带调节由于难以接近植入的胃束带元件而变得复杂。胃束带元件通常初始紧固在脂肪组织的各层之下，这使得各元件难以放置。随着患者体重减轻，各元件能在体内移动，导致患者不舒服和/或使得医生难以定位和接近各元件。
发明内容
因此，本发明提供了用于胃限制装置、特别是用于接近胃限制元件的方法和装置。
本发明总体提供用于调节胃限制系统中的装置的高度的方法和装置。在一种实施方式中，用于在患者体内形成限制的限制系统包括可植入的限制装置，其被构造成在患者体内形成限制。该系统还包括可植入的外壳，其连接到所述可植入的限制装置并具有可调节的高度。所述外壳与所述可植入的限制装置流体连通，并且包括例如填充端口，所述填充端口被构造成从患者体外的流体源接收流体，用于将流体输送到所述可植入的限制装置。在其它实施方式中，所述外壳可以包括压力传感器，所述压力传感器能够感测所述可植入的限制装置内的流体压力，并且能够将压力数据通信到外部监测器。该外壳可以至少部分地由可生物吸收的材料(例如，聚交酯、聚乙醇酸交酯、丙交酯-乙交酯共聚物、聚酸酐和聚原酸酯)形成，并且可操作地随着时间调节该外壳的高度。
系统还可以包括在所述外壳的基部和所述外壳的主体之间延伸的连接元件，该连接元件可以改变所述基部和所述主体之间的距离，从而调节所述外壳的高度。所述连接元件能够在至少两个连续位置之间运动，在所述连续位置中，所述外壳随着所述连接元件的每个连续位置降低高度。
连接元件可以具有多种构造，如可折叠结构、伸缩式绳索、以及流体填充的室，其中该室内的流体容积的变化可以改变基部和主体之间的距离。另一种连接元件的构造包括在外壳的主体和基部之一上形成的可按压元件(例如，按钮)，该可按压元件可以被按压以使连接元件在至少两个连续位置之间运动。在其它实施方式中，该连接元件包括至少一个挠性翼片，其在基部和主体之间延伸并可将外壳维持在一个或多个连续位置。在一些实施方式中，该连接元件包括柔顺(compliant)机构(例如，弹簧)，其可压缩以减小基部和主体之间的距离。该连接元件还可以包括连接到柔顺机构并包括多个齿的齿条。棘爪可以啮合齿条，用于将外壳维持在选择的高度。
在另一种实施方式中，提供了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，其可以在患者体内形成限制；以及可植入的外壳，其连接到可植入的限制装置。该外壳具有主体和基部，所述主体和基部彼此可活动地连接，以允许调节外壳的高度。基部可以由可生物吸收的材料形成，该材料可以随着时间调节外壳的高度。在一些实施方式中，该系统还包括连接元件，其在基部和主体之间延伸，并且可以改变基部和主体之间的距离从而调节外壳的高度。连接元件可在至少两个连续位置之间运动，在所述连续位置，外壳随着所述连接元件的每个连续位置降低高度。
在其它方面，提供了一种在患者体内形成限制的方法。该方法包括：将限制装置植入患者体内以形成限制；以及调节连接到所述限制装置并植入组织内的外壳的高度，以便降低外壳的轮廓。调节外壳的高度可以包括调节在外壳的基部和外壳的主体之间延伸的连接元件。在其它实施方式中，调节外壳的高度包括允许外壳在患者体内生物降解。
本发明具体公开了如下内容：
(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，其被构造成在患者体内形成限制；以及
可植入的外壳，其连接到所述可植入的限制装置并具有可调节的高度。
(2).如第(1)项所述的系统，其中，所述外壳与所述可植入的限制装置流体连通。
(3).如第(2)项所述的系统，其中，所述外壳包括填充端口，所述填充端口被构造成从患者体外的流体源接收流体，用于将流体输送到所述可植入的限制装置。
(4).如第(1)项所述的系统，其中，所述外壳包括压力传感器，所述压力传感器被构造成感测所述可植入的限制装置内的流体压力，并且能够将压力数据通信到外部监测器。
(5).如第(1)项所述的系统，还包括在所述外壳的基部和所述外壳的主体之间延伸的连接元件，该连接元件可操作来改变所述基部和所述主体之间的距离，从而调节所述外壳的高度。
(6).如第(5)项所述的系统，其中，所述连接元件包括流体填充的室，所述室内的流体容积的变化改变所述基部和所述主体之间的距离。
(7).如第(5)项所述的系统，其中，所述连接元件包括柔顺机构，所述柔顺机构可压缩以减小所述基部和所述主体之间的距离。
(8).如第(7)项所述的系统，其中，所述柔顺机构包括弹簧。
(9).如第(7)项所述的系统，其中，所述连接元件还包括齿条和棘爪，所述齿条连接到所述柔顺机构并包括多个齿，所述棘爪能够啮合所述齿条，用于将所述外壳维持在选择的高度。
(10).如第(5)项所述的系统，其中，所述连接元件包括可折叠结构。
(11).如第(5)项所述的系统，其中，所述连接元件包括伸缩式绳索。
(12).如第(5)项所述的系统，其中，所述连接元件能够在至少两个连续位置之间运动，在所述连续位置中，所述外壳随着所述连接元件的每个连续位置降低高度。
(13).如第(12)项所述的系统，其中，所述连接元件包括至少一个挠性翼片，所述挠性翼片在所述基部和所述主体之间延伸并能够将所述外壳维持在所述连续位置中的至少一处。
(14).如第(12)项所述的系统，还包括可按压元件，其能够被按压，以使所述连接元件在至少两个连续位置之间运动。
(15).如第(14)项所述的系统，其中，所述可按压元件包括形成在所述主体和所述基部之一上的按钮。
(16).如第(1)项所述的系统，其中，所述外壳至少部分地由可生物吸收的材料形成，并且可操作地随着时间调节所述外壳的高度。
(17).如第(16)项所述的系统，其中，所述可生物吸收材料选自包括下述各项的组：聚交酯、聚乙醇酸交酯、丙交酯-乙交酯共聚物、聚酸酐和聚原酸酯。
(18).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，其被构造成在患者体内形成限制；以及
可植入的外壳，其连接到所述可植入的限制装置并具有主体和基部，所述主体和基部彼此可活动地连接以允许调节所述外壳的高度。
(19).如第(18)项所述的系统，其中，所述基部由可生物吸收的材料形成，并且可操作地随着时间调节所述外壳的高度。
(20).如第(18)项所述的系统，还包括连接元件，其在所述基部和所述主体之间延伸，并且可操作来改变所述基部和所述主体之间的距离，从而调节所述外壳的高度。
(21).如第(20)项所述的系统，其中，所述连接元件能够在至少两个连续位置之间运动，在所述连续位置中，所述外壳随着所述连接元件的每个连续位置降低高度。
(22).一种在患者体内形成限制的方法，包括：
将限制装置植入患者体内，以形成限制；和
调节连接到所述限制装置并植入在组织内的外壳的高度，以降低所述外壳的轮廓。
(23).如第(22)项所述的方法，其中，调节所述外壳的高度包括调节在所述外壳的基部和所述外壳的主体之间延伸的连接元件。
(24).如第(22)项所述的方法，其中，调节所述外壳的高度包括允许所述外壳在患者体内生物降解。
附图说明
从以下结合附图的详细描述中，将更充分地理解本发明，其中：
图1A是食物摄取限制系统的实施方式的示意图；
图1B是图1的食物摄取限制系统的可植入部分的实施方式的透视图；
图2A是图1的食物摄取限制装置的透视图；
图2B是图2A的围绕患者的胃-食道结合部施加的食物摄取限制装置的示意图；
图3是图1的注入端口外壳的实施方式的透视图；
图4是图1的传感器外壳的实施方式的透视图；
图5是具有设置在外壳的内腔中的流体的可植入端口外壳的实施方式的剖面示意图；
图6是具有设置在外壳的内腔中的流体的可植入传感器外壳的实施方式的剖面示意图；
图7是具有设置在外壳的内腔中的弹簧的可植入外壳的实施方式的剖面示意图；
图8是具有设置在外壳的内腔中的挠性翼片的可植入外壳的实施方式的剖面示意图；
图9是具有可按压元件的可植入外壳的实施方式的剖面示意图；
图10是至少部分由可生物吸收材料形成的可植入外壳的实施方式的剖面示意图；
图11是具有处于展开位置的可折叠结构的可植入外壳的实施方式的示意图；
图12是图11的可植入外壳的示意图，示出了处于折叠位置的可折叠结构；
图13是具有处于展开位置的可折叠结构的可植入外壳的另一实施方式的示意图；
图14是图13的可植入外壳的示意图，示出了处于折叠位置的可折叠结构；
图15是具有能够由棘爪啮合的齿条的可植入外壳的实施方式的示意图；以及
图16是具有伸缩式绳索的可植入外壳的实施方式的示意图。
具体实施方式
现在将描述某些示例性的实施方式，以便提供在此公开的装置和方法的结构、功能、制造和使用的原理的总体理解。在附图中图示了这些实施方式的一个或多个例子。本领域技术人员将理解的是，在此具体描述并且在附图中图示的装置和方法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限定。结合一个示例性实施方式图示或描述的特征可以与其它实施方式的特征结合。这种修改和变化意在包括在本发明的范围内。
本发明总体上提供用于调节胃限制系统中的装置的高度的装置和方法。通常，该装置和方法允许连接到可植入的限制装置的一个或多个可植入外壳具有可调节的高度。该外壳可以包括，例如填充端口外壳、传感器外壳、以及任何其它类型的外壳，其可用于可植入的限制系统并期望具有可调节的高度。该外壳可以随着时间(例如，随着患者体重减轻)轮廓降低，从而将外壳维持在通常可预测的位置，在该位置可以发现和接近该外壳。该轮廓可以在患者体内自动调节，从而减小或消除对涉及调节胃限制系统的侵入性的、昂贵的、耗时的、或有风险的手术的需要。替代地或附加地，可以从患者体外手动调节该外壳的高度，以便例如减轻患者的不舒服。此外，外壳可以包括：基部，其将外壳紧固到患者的筋膜；以及主体，其靠近患者皮肤表面并具有外壳的功能性。外壳的基部和主体可以分开一定距离并且可以由连接元件连接，该连接元件可以操作以改变主体和基部之间的距离。这样，该外壳主体可以在外壳随着时间轮廓降低的同时，维持其通常可预测的位置。
尽管本发明可用于现有技术中已知的多种限制系统，图1A图示了用在患者体内的食物摄取限制系统10的一种示例性实施方式。如图所示，系统10通常包括可植入部分10a和外部部分10b。图1B图示了患者外部的可植入部分10a。可植入部分10a包括：可调节胃束带20，其被定位成围绕患者的胃40的上部；以及注射端口外壳30，其例如经由导管50，流体连接到可调节胃束带20。
注射端口外壳30可以包括连接在一起的端口主体30a和端口基部30b，但是端口主体30a和端口基部30b可以分开一段距离。注射端口外壳30能够通过端口主体30a允许流体被引入胃束带20和从胃束带20移除，从而调节带的尺寸以及施加给胃的压力。注射端口外壳30适于在端口基部30b处固定到患者，该端口基部30b可以在体内允许穿过组织接近端口主体30a的位置植入。典型地，注射端口外壳在皮肤和脂肪组织层下的患者腹部的侧面肋下区域中固定到患者。外科医生也典型地将注射端口外壳固定在患者的胸骨上。无论植入哪里，注射端口外壳30可以如下进一步所述的那样被调节高度。
内部部分10a还可以包括压力感测或测量装置，其与可植入部分10a中的封闭流体回路流体连通，使得该压力感测装置可以测量封闭流体回路的流体压力。尽管压力测量装置可以具有各种配置，并且其可以沿着内部部分10a定位在任何位置，包括在注射端口外壳30内，但在图示的实施方式中，压力测量装置是压力传感器的形式，其放置在邻近注射端口外壳30定位的传感器外壳60内。更具体地，该实施方式中的压力传感器可以放置在传感器外壳60的传感器主体60a中，该传感器外壳60也包括传感器基部60b，其可以固定到患者并且连接到传感器主体60a。导管50可以包括连接在胃束带20和压力传感器外壳60之间的第一部分，和连接在压力传感器外壳60和注射端口外壳30之间的第二部分。尽管在该实施方式中端口外壳30和传感器外壳60都显示具有主体和基部部分，但在一些实施方式中，只有可植入部分10a中的外壳(端口外壳30、传感器外壳60或其它外壳)之一可以具有这样的基部和主体，以调节外壳的高度。
如图1A中进一步图示的，外部部分10b通常包括压力读取装置70，其定位在皮肤表面上且在压力传感器外壳60(其可以在厚组织，例如超过10cm厚的组织下面固定到患者)的上面，以便非侵入性地与压力测量装置通信，从而获得压力测量数据。压力读取装置70可选地电连接(在该实施方式中，经由电缆组件80)到控制箱90，该控制箱90可以显示从压力读取装置70获取的压力测量数据或其它数据。
图2A更详细地示出了胃束带20。尽管胃束带20可以具有多种结构，并且本领域已知的各种胃束带可用于本发明，但是在图示的实施方式中，胃束带20具有大体细长的形状，其支持结构22具有可以相互紧固的第一和第二相对端部20a和20b。各种配合技术可用于将端部20a和20b相互紧固。在图示的实施方式中，端部20a和20b是配合在一起的带状，一个位于另一个上部。在另一种实施方式中，图1B所示，在胃束带20的一端的支撑结构可以包括开口，胃束带20的另一端可以穿过该开口以将各端部相互紧固在一起。胃束带20还可以包括可变容积构件，如可膨胀的囊24，其放置或形成在支撑结构22的一侧上，并且被定位邻近组织。囊24可以抵靠胃的外壁膨胀或收缩，以形成可调节的人造口，用于可控制地限制将食物摄入胃内。
本领域技术人员可以理解，胃束带可以具有各种其它结构。此外，在此公开的各种方法和装置对于其它类型的可植入带具有相同的可应用性。例如，带用于治疗排泄失禁，如美国专利No.6,461,292所述，该美国专利通过引用并入本文。带还可用于治疗尿失禁，如美国专利申请2003/0105385所述，该美国专利申请通过引用合并在此。带还可用于治疗胃灼热和/或酸回流，如美国专利No.6,470,892所述，该美国专利通过引用并入本文。带还可用于治疗阳萎，如美国专利申请2003/0114729所述，该美国专利申请通过引用并入在此。
图2B示出了围绕患者的胃-食道结合部施加的可调节胃束带20。如图所示，带20至少基本上围绕胃40的靠近与食道42的结合部的上部。在植入带20之后，优选在带20处于包含很少或没有流体的收缩结构下被植入后，例如可以使用盐水使带20膨胀，以减小人造口开口的尺寸。本领域技术人员可以理解，包括机械和电力技术的各种技术都可用来调节带。
流体注射端口外壳30还可以具有各种结构。在图3所示的实施方式中，注射端口外壳30的端口主体30a和端口基部30b均呈大体圆柱形形状。端口主体30a可以至少部分地围绕端口基部30b，如图所示。此外，在图3中显示端口主体30a和端口基部30b被压到一起，但是端口主体30a和端口基部30b可以分开一段距离。端口主体30a可以各种方式与端口基部30b连接，如以下描述的，其通常允许外壳30具有可调节的高度，使得端口主体30a可以维持靠近患者皮肤的表面，同时端口基部30b在下述位置将端口外壳30固定到患者，该位置可以远离端口主体30a，并且典型地是最初跟随外壳30的植入。
端口主体30a具有远侧或底部表面和周壁，其从底部表面向近侧延伸并且限定近侧开口32。近侧开口32可包括延伸穿过该开口并提供了在端口主体30a中形成的流体容器(在图3中不可见)的入口的针穿刺膜34。膜34优选设置在足够近侧的位置，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。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，端口外壳30还可包括导管连接件36，该导管连接件36与容器流体连通并被构造成与导管50连接。本领域技术人员将会理解，外壳30可由任意数目的材料制成，包括不锈钢、钛或者聚合物材料，并且膜34同样可由任意数目的材料制成，包括硅树脂。
如上所述，如图4所示，系统10还可包括与封闭流体回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流体压力的压力测量装置64。测量流体压力使医生能够评估由束带调节形成的限制。在图示的实施方式中，压力测量装置64为设置在传感器外壳60的传感器主体60a中的压力传感器的形式。但是，压力测量装置64可设置在可植入部分10a的封闭液压回路中的任何位置，并且各种示例性位置和构造在共同拥有的美国专利公开No.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 Measurement In a Fluid AdjustableRestrictive 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包括与系统10中的流体流体连通的入口62a和出口62b，入口62a和出口62b通常为传感器主体60a的一部分。传感器64可设置在传感器外壳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。尽管未示出，压力感测系统可包括微控制器、TET/遥测线圈、以及电容器。任选地，压力感测系统还可包括温度传感器(未显示)。微控制器、TET/遥测线圈、以及电容器可通过电路板(未显示)或通过任何其他合适的组成元件通信。还可理解的是，TET/遥测线圈和电容器可一起形成调谐振荡电路，以便从外部部分接收功率以及将压力测量结果传递到压力读取装置70。
可使用本领域已知的各种压力传感器，诸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，但合适的微机电系统(MEMS)压力传感器也可从任何其他来源获得，包括但不限于：Integrated Sensing Systems公司(ISSYS)(伊斯兰提，密歇根州)和Remon Medical Technologies公司(沃尔瑟姆福，马萨诸塞州)。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。
压力读取装置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，每篇文献的内容通过引用而包含于本申请中。总体而言，压力读取装置70可以非侵入方式测量被植入部分中的流体压力，即便在注射端口外壳30或者压力测量装置64被植入到厚(至少超过10cm)的皮下脂肪组织之下时也是如此。医生可依靠压力测量装置64的位置附近的患者皮肤保持压力读取装置70，并观察控制箱90上的显示器上的压力读数。包括压力测量装置64的外壳可以可触知地位于靠近患者皮肤的表面处，典型地在或靠近外壳主体的期望位置，如果和/或当外壳的轮廓降低时，该主体基本上可以维持其位置。压力读取装置70还可以使用条带、粘合剂和其他公知方法可拆卸地连接到患者，诸如在延长的检查过程中。压力读取装置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)。
图5至16图示了外壳的各实施方式，其每个包括主体和基部。一些实施方式还包括至少一个在主体和基部之间延伸的连接元件。该外壳、基部和主体类似于参照图1A至4的类似命名的元件描述的那些。此外，图5至16的实施方式可以包括如在此描述的变化。通常，该外壳主体设置可植入的限制系统元件，例如，填充端口或传感器，其可以与包括在可植入限制系统中的一个或多个其它元件流体连通。该外壳基部使用任何固定技术(例如，缝线缝合)将外壳连接到患者。外壳的主体和基部可活动地相互连接，以便允许外壳的高度向上和/或向下从第一高度到第二高度调节，该第二高度依赖于外壳的高度是被减小或增大而可以小于或大于第一高度。外壳可以在第一和第二高度之间具有任意数量的另外的高度，如果外壳的高度减小，则具有小于之前(各)高度的高度，或者如果外壳的高度增大，则具有大于之前(各)高度的高度。如果外壳轮廓被增大以例如调节患者的治疗状况，则外壳高度可以超过一个或多个之前的高度。外壳的最大和最小高度可以改变，但是在一些实施方式中，外壳的高度范围为大约1cm到3cm。
首先参照图5至9，外壳100的各实施方式每个包括外壳主体102、外壳基部104和至少一个在主体102和基部104之间延伸的连接元件，连接元件可以操作来改变主体102和基部104之间的距离，从而调节外壳100的高度。连接元件大致位于外壳100中，例如在由主体102的内表面108和基部104的内表面110限定的内腔106中。表面108和110可以限定内腔106以具有流体紧密密封。主体的内表面108和基部的内表面110被成形为可滑动地将主体102和基部104连接在一起。内腔106围绕外壳100周边延伸，其在这些实施方式中是围绕基本上圆柱形外壳100的圆形圆周。在其它实施方式中，内腔106可以只围绕外壳周边的一部分延伸和/或被划分为两个或更多个独立的内腔。主体的内表面108和基部的内表面110还可以在外壳100的中间区域中限定第二内腔112。在一些实施方式中内腔106和112可以流体连通。此外，内腔106和112每个可以具有任何形状和尺寸。通过从患者体外，例如由医生控制操作内腔106中的连接元件，可以调节外壳100的高度。外壳100可以在外壳基部104的近侧部分138中的外表面136上的一个或多个位置处连接到患者。
如图5所示，连接元件的一个例子包括位于主体102和基部104之间的内腔106中的流体114(例如液体，如盐水，或气体，如二氧化碳)。流体114通常包括适于在身体中使用的任何类型的生物相容性材料，以便在外壳破裂或其它不希望的流体泄漏的异常情况发生时使得对患者的伤害最小化。内腔106和其包含的任何流体可以通过外壳主体102上的外壳隔膜116进入。外壳隔膜116可以使用波纹管(bellow)密封流体。尽管内腔106可以在外壳植入前包含流体114，但是流体114通常在外壳100已经植入后，通过外壳隔膜116被初始引入到内腔106。除了或替代外壳主体102上的外壳隔膜116，外壳基部104也可以具有提供进入内腔106的入口的外壳隔膜。外壳隔膜116类似于图3的端口的针穿透膜34，允许针118，如休伯针，刺穿外壳隔膜116，并且在针118退回后自密封。当例如通过针118吸取流体而使内腔106中的流体容积改变时，外壳主体102和外壳基部104之间的高度可以减小。换句话说，当至少部分流体114从内腔106中排出时，随着基部的内表面110移动更靠近主体的内表面108，并且占据之前由流体114占据的内腔106中的一定空间，外壳的轮廓可以降低。
可以从内腔106中移除足够的流体104，使得当基部102和主体104相互足够靠近时，例如，当连接元件将基部102和主体104拉到一起和/或主体102和基部104物理地压缩到一起时，主体102和基部104可以经由锁定机构锁定在一起。锁定机构的例子包括弹簧锁机构(如图5所示)和压缩压配合机构。该实施方式中的主体的内表面108包括至少一个凸起120，其可以锁定在基部的内表面110中的至少一个对应的凹部122中。在该实施方式中，凸起120和凹部122围绕外壳的周边延伸，但是外壳100可以包括在内表面108和110的任何位置中，包括在第二内腔112中的任意数量的对应的凸起和凹部。
图5所示的外壳100的实施方式是端口外壳(例如，端口外壳30)，其具有放置在外壳主体102(例如，在外壳100的近侧开口)中的膜124和容器126。外壳主体102还包括倒钩配合连接件128(例如，导管连接件36)，其与容器126流体连通并且被构造为连接到导管130(例如，导管50)。连接件128可以在任何位置连接到外壳主体102。此外，在以下进一步讨论的一些实施方式中，外壳基部104可以在其周边具有开槽或其它切开的区域(在该情况下，外壳基部104可以不具有完整圆周)，以便允许连接件128和/或导管130从外壳主体102延伸。
图6所示的外壳100类似于图5的实施方式，除了图6的外壳100是具有在外壳主体102中放置的传感器132(例如，压力测量装置64)的传感器外壳(例如，传感器外壳60)。尽管未示出，外壳主体102和/或外壳基部104可以包括一个或多个连接件(例如，连接件128)，以便适应用于传感器132的各导管连接(例如，入口62a和出口62b)。
在一些实施方式中，主体102和基部104之间的连接元件可以包括柔顺机构，其可压缩以减小外壳主体102和外壳基部104之间的距离。柔顺机构的一个例子是弹簧134，如图7所示。弹簧134可以包括具有任何形状的任何挠性弹性件。例如，弹簧134可以包括具有如图7所示的具有圆柱形形状的线圈或螺旋状弹簧，尽管螺旋弹簧可以具有其它形状，如圆锥形或双圆锥形，并且具有任何形状的单独的线圈，如椭圆形或矩形。弹簧134的其它例子包括弹性带/螺线/绳索、波纹管(见图11-12，以下将讨论)、锥形弹簧(见图13-14，以下将讨论)、和其它类似类型的挠性弹性件。弹簧134还可以具有各种尺寸，并且用于外壳100的不同弹簧可以具有不同尺寸(和形状)。弹簧134可以由任何类型的材料和其任何组合制成，通常是适合用于体内的生物相容性材料，如高分子、生物相容性金属、和其它类似类型的材料。
如图7所示，弹簧134放置在内腔106中，并且在主体102的内表面108和基部104的内表面110之间延伸。替代地或者附加地，弹簧134可以在第二内腔112中在主体102的内表面108和基部104的内表面110之间延伸。所示的弹簧134包括位于圆柱形外壳100的相对侧的两个单独的弹簧，但是任何数量的弹簧可以在主体102和基部104之间延伸。例如，一个或多个弹簧可以围绕外壳100的周边、以一定的间隔(任意两个或多个弹簧之间的间隔可相等或可变)放置在内腔106内。如另一个例子，可以如图7所示放置弹簧134，设置在第二外腔112中央的附加的弹簧在内表面108和110之间延伸。
弹簧134具有至少两个连续位置：展开位置和折叠位置。弹簧134典型地初始处于展开位置，其中该弹簧被偏压以维持主体102和基部104之间的基本恒定的距离。一次或多次压缩可以施加到弹簧134以将弹簧134压缩到折叠位置，从而减小外壳100的高度到其最低轮廓。弹簧134在展开位置和折叠位置之间可以具有一个或多个连续位置，使得施加到弹簧134的一次或多次压缩可以使弹簧134对准并维持在其扩展位置和折叠位置之间的部分地折叠的位置，从而允许外壳100利用每个连续位置降低高度。
压缩可以以多种方式施加到外壳100，如通过从患者体内和/或体外施加压力给主体102和/或基部104。该外壳100典型地由医生压缩，以有利于防止伤害患者和确保外壳100的连续正常的运转。
外壳100可以包括安全机构，在施加到主体102和/或基部104上的压力可以改变外壳100的轮廓之前，该安全机构必须从锁定位置改变到未锁定位置。安全机构的例子包括位于外壳100上或外壳100中的机械锁或电子锁，医生可以通过患者体内的切口物理地操作或使用靠近外壳100的位置且抵靠患者的皮肤放置的电子设备来非侵入性地操作。
当弹簧134已经被压缩到一定程度使得主体102的内表面108和基部104的内表面110彼此相互足够接近时，锁定机构，如对应的凸起137和凹部139，可以如上所述将主体102和基部104啮合和锁定在一起。在一些实施方式中，弹簧134的一次或多次压缩可以使得弹簧134断开，允许外壳100减小高度。该断开的弹簧可以保留在内腔106内，并且各端仍然连接到主体102的内表面108和基部104的内表面110。在弹簧134断开的情况下，主体102和基部104可以压缩到一起，并且经由锁定机构锁定。
图7所示的外壳100还包括连接到外壳主体102的连接件128。在该实施方式中，导管130延伸通过外壳主体102、第二内腔112和外壳基部104，从外壳基部104的近侧部分138而不是从外壳主体102离开外壳100。这种结构可以允许导管130延伸到外壳100外部较短的距离，从而降低导管钩住、缠结和断裂的可能性，因为外壳主体102和外壳基部104可以被厚的皮下脂肪组织分开，同时外壳基部104比外壳主体102更接近导管130的下一目标(例如，传感器外壳)。
连接元件的另一个例子是可以在第一位置和连续的第二位置之间运动的任意元件，其中，在第一位置，外壳100具有第一高度，在连续的第二位置，外壳100具有不同于第一高度的第二高度。连接元件还可以在从第一位置运动到第二位置之前和/或之后，在一个或多个连续位置之间运动，使得外壳的高度在每个连续的位置降低。这种连接元件的一个例子是翼片140，如图8所示。翼片140可以包括在主体102和基部104之间延伸的至少一个挠性翼片，其可以将外壳100维持在至少一个连续位置。翼片140可以具有任何尺寸和任何形状。例如，翼片140可以包括杆、折翼和其它类似类型的椭圆形、矩形、线形、或其它形状的、具有两维或三维的元件。翼片140可以由任何类型的材料或其任何组合制成，所述材料典型地为适用于体内的生物相容性材料。
翼片140位于内腔106中，并且在主体102的内表面108和基部104的内表面110之间延伸。图8所示的两个翼片140在外壳100的相对侧，但是外壳100可以包括任意数量的任何结构的翼片。
在该实施方式中，翼片140包括翼片主体部分142和L形托架144。外壳100可以包括任意数量的翼片主体部分142和任意数量的L形托架144，其中一个L形托架144可以与一个或多个翼片主体部分142相关联。翼片主体部分142连接到外壳主体102的内表面108，翼片主体部分142以基本上垂直的方向，尽管其可以任何方向从所述外壳主体102的内表面108延伸以允许其接合L形托架144。L形托架144从外壳基部104的内表面110、以基本上垂直的方向延伸并朝向外壳主体102的内表面108成角度，以允许以锁步方式与翼片主体部分142接合。
翼片140具有至少两个位置。翼片140示出为处于第一位置，其中L形托架144与最远侧的翼片主体部分142接合。外壳基部104可以朝向外壳主体102被压缩，如上所述，从而使翼片主体部分142与L形托架144分离，并且将翼片140推入第二位置，在该第二位置提供了比处于第一位置中的翼片140更低的外壳轮廓。当外壳100被压缩时，内表面108和110相互接近，并且L形托架144可以与另一翼片主体部分142接合(如果主体102包括超过一个翼片主体部分142)。翼片主体部分142典型地由挠性材料制成，其可以弯曲以与L形托架144分离，并且L形托架144也可以或替代地由挠性材料制成，以帮助接合/分离翼片部分142。如果当外壳主体102和外壳基部104被压缩在一起时L形托架144没有翼片主体部分来接合，则外壳主体102和外壳基部104可以压缩在一起以接合锁定机构，也如上所述。
在该实施方式中，锁定机构包括翼片140，更具体地，包括翼片主体部分142和形成在外壳基部104的外表面136中、从该外表面136切出、或以其它方式存在(或依赖于外壳主体102上的翼片主体部分142的位置在外壳基部104的内表面110上)的槽146。翼片主体部分142可以接合槽136，从而锁定外壳主体102和外壳基部104。槽146典型地在外壳基部104的近侧部分138中。如果外壳100包括两个或更多翼片140，则任意数量的翼片140可以具有对应的槽146，但是一个槽146接合一个翼片140足以锁定外壳100。
如图9所示，可活动的翼片148是连接元件的另一个例子，其可以在第一位置和连续的第二位置之间运动，其中，在第一位置，外壳100具有第一高度，在连续的第二位置，外壳100具有不同于第一高度的第二高度，在第一和第二位置之前和/或之后具有任意数量的连续位置。可活动的翼片148可以是参照图8所述的翼片，其在外壳100上具有任何尺寸、任何形状、任何数量和结构、和任何材料成份。类似于翼片主体部分142，可活动的翼片148可以接合一个或多个槽150，类似于图8的槽146。然而，不同于翼片主体部分142，可活动的翼片148连接到至少部分延伸到外壳主体102外的可按压元件152，其可以被按压以将可活动的翼片148从第一位置运动到第二位置(以及任何其它可能的连续位置)。换句话说，可按压元件152可以被按压，以便通过运动可活动的翼片148将外壳主体102和外壳基部104压缩在一起，使得可活动的翼片148可以接合一个或多个槽150。
可按压元件152可以具有多种结构，其允许可按压元件152运动可活动的翼片148。在图示的实施方式中，可按压元件152包括形成在外壳主体102上的按钮，尽管该按钮可以形成在外壳100上的任何位置。外壳100典型地包括一个所示的可按压元件152，尽管外壳100可以包括任意数量的可按压元件152。可按压元件152可至少部分地从外壳100外被接触，不管其是否延伸到外壳主体的后表面164之外。如果可按压元件152没有延伸到外壳主体的后表面164之外(这可降低可按压元件152被意外按压的可能性)，则可以使用诸如针的器械来按压可按压元件152。
可按压元件152可以经由细长轴154连接到可活动的翼片148。细长轴154可以从可按压元件152延伸，并且进入在外壳主体102中形成的孔156内。可活动的翼片148可以连接到孔156内的细长轴154，并且延伸到内腔106中，在该位置翼片148可以接合槽150。在该实施方式中，细长轴154直接接合可活动的翼片148，但在一些实施方式中，在细长轴154和可活动的翼片148之间可以包括一个或多个另外的元件。此外，一个或多个另外的可活动翼片可以连接到细长轴154，并且在按压可按压元件152时可以类似于可活动的翼片运动。放置在孔156中并且连接到可活动的翼片148的弹簧158(其可以具有任何结构，如上面参照图7的弹簧134所述)在可按压元件152处于未按压位置时，可以提供足以将可活动翼片148保持在内腔106和孔156内的位置的张力。可按压元件152可以可移除地或固定地连接到细长轴154。
按压可按压元件152还可以按压细长轴154。细长轴154在被按压时可以沿着一个或多个轴承160(或其它可滑动元件)、以远离内腔106和朝向孔156的方向可滑动地运动可活动的翼片148，使得弹簧158压缩。尽管示出了5个轴承160，但是任何数量的轴承160可以设置在孔156中。完全按压可按压元件152可以提供可活动翼片148的足够的可滑动运动，以便将可活动翼片148从槽150分离，尽管在其它实施方式中，可按压元件152的部分按压可以将可活动翼片148从槽150分离。可活动翼片148典型地由足够刚性的材料制成，使得例如如果外壳100被物理地按压、而不是按压可按压元件152允许其从槽150移出，则其不会脱离槽150。在可活动的翼片148脱离槽150并且处于另一位置时，外壳主体102和外壳基部104可以被按压在一起，如上所述。可按压元件152可从按压位置被释放，从而释放来自弹簧158的张力，并且允许可活动翼片148沿着轴承160朝向内腔106滑动。当槽150之一与可活动的翼片148适当地对齐时，可活动的翼片148可以接合槽150并且处于提供另一外壳轮廓的另一位置。槽150与翼片148适当地对齐可以出现在可按压元件152已经释放之前或之后，因为外壳基部104的外表面136可以防止可活动的翼片148移入内腔106中，直到槽150之一与可活动的翼片148适当对齐。
除了可活动的翼片148之外，外壳100可以包括一个或多个连接元件。该另外的(各)连接元件可以具有任何结构，尽管典型地至少一个另外的连接元件位于外壳100的与可活动的翼片148的相对侧，以便帮助维持水平外壳轮廓。例如，如图9所示，外壳100可以包括如上参照图8所示的翼片162，其在外壳主体102和外壳基部104压缩在一起时可以接合一个或多个槽150。可用的槽150的数量典型地与可活动的翼片148和任何其它的连接到外壳主体102的翼片(例如，翼片162)的数量相同，以便帮助维持水平外壳轮廓。
图10图示了外壳200的另一种实施方式，该外壳200至少部分由可生物吸收的材料制成，并且可操作随着时间调节外壳200的高度。可生物吸收的材料可以在患者体内降解，从而与降解成比例地降低外壳200的轮廓。外壳200包括由适用于体内的生物相容性材料形成的主体202、和由可生物吸收材料形成的基部204。可生物吸收材料可以均匀地(例如，大块水解)或与其表面积成比例地降解。可生物吸收的材料的例子包括可生物吸收的聚合物，如聚交酯(PLA)、聚乙醇酸交酯(PGA)、丙交酯-乙交酯共聚物(PLGA)、聚酸酐、聚原酸酯和其它类似类型的材料，其可以在患者体内分解并可以被吸收或由患者的身体另外地安全处理。
任意量的可生物吸收材料可用于形成具有任何高度H的基部204。高度H通常对应于筋膜和设置在主体102中的可植入限制元件之间的期望距离，外壳200在筋膜处固定到患者，在该实施方式中可植入的限制元件是包括容器206和膜208的端口。随着基部204的可生物吸收材料被再吸收，基部204的高度H可以减小，从而将外壳200从最大高度运动到最小高度，在其间具有任意数量的连续高度。可生物吸收材料可以降解以允许任何时间段上，例如植入后的两到三年的不同高度。
图11至16中的各种结构中图示的外壳300的其它实施方式包括外壳主体302、外壳基部304和至少一个在主体302和基部304之间延伸的连接元件306，其可操作来改变主体302和基部304之间的距离以调节外壳300的高度。锁定机构可以如上所述将外壳主体302和外壳基部304接合并锁定在一起。这些实施方式中的连接元件306不需要大致放置在外壳主体302或外壳基部304中。而是，连接元件306例如可以在外壳主体302和外壳基部304各自的内表面308和310处连接外壳主体302和外壳基部304的外表面。当外壳300具有任何高度，但是典型地，至少当外壳300处于其最大高度时，连接元件306的部分可以延伸进入外壳主体302和/或外壳基部304，基本上所有连接元件306放置在外壳主体302和外壳基部304的外部。当连接元件306被植入时脂肪组织可以被压紧在连接元件306周围，以帮助保持连接元件的位置并且帮助允许减轻体重来改变连接元件的位置。尽管图11至16中未示出，连接元件306可以包括至少围绕其外表面的部分放置的保护套，类似于波纹管。连接元件306(和其套，如果存在的话)可以由任何适用于体内的生物相容性材料制成。
外壳300还可以包括连接件312(例如，导管连接件36)，其可以连接到外壳主体302和导管314(例如，导管50)。在图13至14中，连接件312以从外壳主体302水平延伸的侧向构造示出，但是连接件312在外壳主体102上可以具有其它构造。例如，如图11至12所示，连接件312可以从外壳主体302的内表面308竖直延伸。
连接元件306的一种实施方式包括柔顺机构，例如可折叠结构，其具有展开位置，如图11所示，其中外壳300具有高度H1，以及具有折叠位置，如图12所示，其中外壳300具有低于高度H1的高度H2。连接元件306的另一种实施方式包括图13和14所示的柔顺机构，其包括类似于图11和12所示的可折叠结构(H1和H2在图11-12和图13-14中不必表示相同高度)。如以下进一步描述的，图11至14中的连接元件306可以包括具有任何构造的任何挠性件，如上参照图7的弹簧134所述。随着患者体重减轻，连接元件306可以随着支撑该连接元件的脂肪组织的消耗而折叠。连接元件306还可以或替代地被手动压缩，如上参照弹簧134所述。在外壳300具有低于其最大高度的高度的位置，连接元件306的一些或全部可以折叠到外壳基部302、外壳主体304和/或其自身中。例如，从图13所示的位置，连接元件306已经套入在其自身中以具有图14所示的位置。
如图15所示，在外壳300的另一种实施方式中，连接元件306包括如弹簧316(例如，上面参照图7的弹簧134所述的弹簧)的柔顺机构，其可压缩以减小外壳主体302和外壳基部304之间的距离。连接元件306还包括具有多个齿320的齿条318。齿条318可以经由棘爪322连接到弹簧316，该棘爪322可以啮合齿320用于将外壳300维持在选择的高度。
齿条318可以具有允许外壳300的高度调节的任何构造。在图示的实施方式中，齿条318以基本上矩形箱形的结构在外壳主体302的内表面308和外壳基部304的内表面310之间延伸，尽管齿条318可以具有任何两维或三维形状。齿条318还可以具有任何尺寸。齿条318还可以包括如弹簧324(例如，上面参照图7的弹簧134所述的弹簧)的支撑件，以便帮助在外壳主体302和外壳基部304之间提供稳定性。齿条318可以由任何类型的刚性和/或挠性材料和其任何组合制成，典型地由适合用于体内的生物相容性材料制成。
如果齿条318由挠性材料制成，则随着外壳的高度改变，齿条318可以通过外壳基部304改变方向，如外壳基部304内的虚线和外壳基部304的左侧表面外的实线所示。然而，齿条318可以被改变方向以延伸到外壳基部304的任何表面外。在改变方向之前和/或之后，齿条318还可以布置在外壳基部304内。例如，外壳300可以不充分折叠以包括外壳基部304内的改变方向的齿条部分。作为另一个例子，对于外壳300的任何给定高度，外壳基部304可以是足够大以容纳齿条318和/或齿条318可以充分挠曲以在外壳基部304内改变方向。
连接到齿条318的齿320还可以具有任何形状和尺寸，并且可以由任何材料，典型地由生物相容性材料构成。齿320可以定向在齿条318上，以与棘爪322一起允许在期望的方向(例如降低外壳高度的方向)上的齿条318的运动。棘爪322可以包括任何凸起，其可以接合齿320以将外壳300维持在选择的高度。棘爪322可以抵靠任何一个齿320的表面以维持外壳高度，并且可以在一个或多个其它齿320之间活动以改变外壳的轮廓。将棘爪322连接到患者的弹簧316，以及齿320和棘爪322的形状可以偏抵齿条318与期望方向相反的运动。尽管示出弹簧316和齿条318在静止、非运动的位置基本上相互垂直定向，但是弹簧324和齿条318可以以任何方向相互定向，其可以允许棘爪322啮合齿320和外壳300改变高度。
图16图示外壳300的又一种实施方式，其中连接元件包括伸缩式绳索306，其在内表面308和310处连接外壳主体302和外壳基部304，尽管伸缩式绳索306可以连接到外壳主体302和外壳基部304的任何表面。伸缩式绳索306可以包括具有任何形状和任何长度的任何挠性弹性绳索(例如，绳、线、带、纤维等)。伸缩式绳索306可以由任何类型的材料和其任何组合制成，典型地是适用于体内的生物相容性材料。如图16的方向箭头所示，患者的脂肪或组织可以提供力以维持外壳基部304和外壳主体302的分开。该力可以将伸缩式绳索306维持在特定位置(例如，将伸缩式绳索306维持在特定长度)。随着患者体重减轻，伸缩式绳索306上的力可以改变，从而允许伸缩式绳索306缩回到外壳主体304中，并且允许外壳300改变高度。
伸缩式绳索306可以以多种方式布置于外壳基部304内。例如，如该实施方式中所示，伸缩式绳索306可以卷绕置于外壳基部304内的卷轴326，并且连接到伸缩式绳索306的一端。该实施方式中的卷轴326基本上是椭圆形，并且由刚性的、生物相容性材料制成，但是卷轴326可以具有任何形状、尺寸和组分。卷轴326还可以在外壳基部304内具有任何定向，其中伸缩式绳索306以基本上平行于卷轴平面的方向延伸到外壳基部304外。如另一个例子，在其它实施方式中，伸缩式绳索306可以在外壳基部304内折叠。
本领域技术人员可以理解，本发明可以应用于传统的内窥镜和开放式外科仪器中以及应用在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，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 (9)

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，其被构造成在患者体内形成限制；以及
可植入的外壳，其连接到所述可植入的限制装置并具有可调节的高度，所述外壳与所述可植入的限制装置流体连通。
2.如权利要求1所述的系统，其中，所述外壳包括填充端口，所述填充端口被构造成从患者体外的流体源接收流体，用于将流体输送到所述可植入的限制装置。
3.如权利要求1所述的系统，其中，所述外壳包括压力传感器，所述压力传感器被构造成感测所述可植入的限制装置内的流体压力，并且能够将压力数据通信到外部监测器。
4.如权利要求1所述的系统，所述外壳还包括在所述外壳的基部和所述外壳的主体之间延伸的连接元件，该连接元件可操作来改变所述基部和所述主体之间的距离，从而调节所述外壳的高度。
5.如权利要求4所述的系统，其中，所述连接元件包括流体填充的室，所述室内的流体容积的变化改变所述基部和所述主体之间的距离。
6.如权利要求4所述的系统，其中，所述连接元件包括具有挠性和弹性的柔顺机构，所述柔顺机构可压缩以减小所述基部和所述主体之间的距离。
7.如权利要求6所述的系统，其中，所述柔顺机构包括弹簧。
8.如权利要求6所述的系统，其中，所述连接元件还包括齿条和棘爪，所述齿条连接到所述柔顺机构并包括多个齿，所述棘爪能够啮合所述齿条，用于将所述外壳维持在选择的高度。
9.如权利要求4所述的系统，其中，所述连接元件包括可折叠结构。
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EP2433592B1 (en) 2014-06-25
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EP2070494B1 (en) 2012-01-25
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US8100870B2 (en) 2012-01-24
US20090157106A1 (en) 2009-06-18

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