CN101467922B - 用于调节限制装置的恒力机构 - Google Patents
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Abstract
本发明提供了用于调节限制系统的方法和装置，更具体地涉及用于调节限制装置的恒力机构。在一种示例性的实施方式中，提供一种限制系统，该限制系统具有限制装置，其连接到其内设有流体的端口，从而该限制装置适于在通路中形成对应于所含流体量的限制；还具有压力调节单元，其与端口相连通并有效地保持在限制装置与压力调节单元之间基本恒定的平衡压力。该压力调节单元用于响应在其上作用的流体压力来调节限制装置中流体的量。
Description
技术领域
本发明涉及一种在通路中形成限制的方法和装置，特别地，涉及在限制系统中用于控制流体压力的恒力机构和方法。
背景技术
肥胖越来越受到人们关注，特别是在美国，由于肥胖人数持续增长，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特别地造成了患有严重健康问题的重大风险。相应地，大量的关注集中于治疗肥胖患者上。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。胃束带通常包括充有流体且具有固定端点的弹性囊，该囊紧邻在食道和胃的连接处下方围绕胃，从而在带的上方形成了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，将流体从束带移除。束带的作用是减小胃的可用容量从而减小在吃“饱”之前可以被摄入的食物量。
利用上面所描述的每一种限制装置进行安全有效地治疗需要定期地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，胃中的人造口开口最初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。另外，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，或在更紧急的情况下，减轻阻塞或严重的食道扩张症。传统地，调节液压胃束带需要预约就诊，在就诊期间使用皮下注射针头和注射器透过患者的皮肤并增加囊中的流体或从囊中去除流体。近来，已经开发出的可植入泵，它们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，医师将程序装置的手持部分靠近胃的植入物并传递动力和控制信号给植入物。该植入物继而调节带中的流体水平并传递响应指令给程序装置。
尽管此类技术能够成功地调节带压，但仍有必要继续改进技术。通常的液压胃束带装置施加持续的作用力于胃上以减小胃上部的尺寸并限制食物从胃的上部到下部的通路。但是通常的液压胃束带装置的副作用和并发症包括由于束带作用在胃的外部的恒压引起的对胃的外部组织的侵蚀。另外，随着时间的推移，液压束带无法提供稳定的束缚。束带内流体会缓慢地扩散通过弹性体。因此，随着时间的推移，液压束带无法保证带的最佳结构。需要多次调节以维持带的最佳结构，这就增加了成本和就诊次数。同样，对束带的调整需要刺穿皮肤，给患者带来不适并增加感染的风险。
因此，仍需要用于调节液压限制系统的方法和装置。
发明内容
总的来说，这里提供了用于自动地调节通路中的限制的方法和装置。在一种实施方式中，提供了一种自调节限制系统，其包括用于在通路中形成限制的限制装置；和与限制装置相连通的压力调节单元，该压力调节单元有效地通过调节限制装置中的流体量来保持在限制装置与压力调节单元之间基本恒定的平衡压力。该限制装置可包括能够在通路中形成限制的流体囊。在一种示例性的实施方式中，限制量对应于流体囊内含有的流体量。
压力调节单元可以用多种形式设计，但是在一种示例性的实施方式中，该单元包括恒力机构，该恒力机构连接到与限制装置流体相通的流体连通腔室。在一种实施方式中，恒力机构是镍钛合金弹簧。在另一种实施方式中，恒力机构可包括与凸轮面接触的弹簧。该弹簧还可包括悬臂梁，限制系统可包括设定点调节机构，该设定点调节机构可包括可沿悬臂梁运动的可调节块体，以调节悬臂梁的有效长度。对悬臂梁有效长度的调节容许压力调节单元基本恒定的压力可以被调节。
在另一种实施方式中，恒力机构可包括布置在腔室内并与活塞相连的恒力弹簧。还可包括设定点调节机构，在一种实施方式中，该设定点调节机构可包括连接到活塞上的可调节囊，该可调节囊通过调节可调节囊与腔室之间产生的摩擦量来调节压力调节单元的基本恒定的压力。而在另一种实施方式中，恒力机构可以是压缩卷簧，流体相通腔室可以是连接到压缩卷簧上的可膨胀的流体囊。还可包括设定点调节机构，在一种这样的实施方式中，该设定点调节机构可包括连接到压缩卷簧上的波纹管，该波纹管用于通过调节压缩卷簧的长度来调节基本恒定的压力。恒力机构的另一种实施方式可包括内含饱和流体的腔室，该腔室用于与腔室容量无关地保持基本恒定的压力。还可包括设定点调节机构，在一种这样的实施方式中，该设定点调节机构可用于通过改变饱和流体的成分来调节基本恒定的压力。在另一种实施方式中，恒力机构可包括受到真空力的腔室。还可包括设定点调节机构，在一种这样的实施方式中，该设定点调节机构用于通过改变作用在受到真空力的腔室的压力来调节基本恒定的压力。
在其他方面，恒力机构可包括用于有效地维持基本恒定压力的渗透泵。该渗透泵可包括内含渗透液体并与限制装置流体相连的致动腔室，以及包括将致动腔室与流体腔室(例如人体或填充有流体的壳体)隔开的半透膜。在另一种实施方式中，渗透泵可包含内含流体的流体腔室、内设活塞的致动腔室和将致动腔室与流体腔室隔开的半透膜。在其他方面，渗透泵可包括生物所能分解的塞子，该塞子覆盖了半透膜的至少一部分且被设计成在预定的时间周期内分解。
在另一个方面，限制系统可包括设定点调节机构，其用于调节压力调节单元的基本恒定压力。在一种示例性的实施方式中，设定点调节机构可以是围绕可膨胀囊设置的恒压弹簧，该可膨胀囊是可膨胀的以调节基本恒定压力。在另一种示例性的实施方式中，设定点调节机构可以是杠杆和可调支点，该杠杆用于施力于压力调节单元，该可调支点连接到杠杆上并可沿杠杆运动，以调节由杠杆施加的力从而调节基本恒定压力。
这里还提供了用于自动地调节限制装置的系统的另一种实施方式，其通常包括流体容器；限制装置，其与流体容器流体相通并用于在通路中形成对应于限制装置内含流体量的限制；和恒力机构，其连接到流体容器上并用于施加基本恒定的力给流体容器以保持限制装置中基本恒定的压力。该恒力机构可具有多种结构。例如，恒力机构可以是设在腔室内并连接到活塞上的恒力弹簧。在一种示例性的实施方式中，胃限制装置包括内含流体的流体囊。该系统还可包括连接到恒力机构上的设定点调节单元，该设定点调节单元适于改变由恒力机构施加的基本恒定的力。例如，设定点调节单元可以是一个可膨胀囊。
还提供了一种用于在通路中保持限制的方法。在一种示例性的实施方式中，限制装置被植入患者体内以在通路中形成限制，使得该在通路中的限制对应于限制装置内含有的流体量。该限制装置可连接到压力调节单元，该单元施加基本恒定的力给限制装置内的流体以保持由限制装置作用于通路的基本恒定的力。该方法进一步包括使用设定点调节机构来调节压力调节单元的基本恒定的力。在一种实施方式中，流体流入限制装置内可增加由限制装置作用于通路的限制量。优选地，该限制装置被植入以在患者的胃里形成限制。
更具体地说，本发明涉及如下内容：
(1)、一种自调节限制系统，包括：
用于在通路中形成限制的限制装置；和
与限制装置相通的压力调节单元，该压力调节单元通过调节限制装置中的流体量，有效地在限制装置与压力调节单元之间保持基本恒定的平衡压力。
(2)、如第(1)项所述的系统，其中，所述压力调节单元包括恒力机构，该恒力机构连接到与所述限制装置流体相通的流体连通腔室。
(3)、如第(2)项所述的系统，其中，所述恒力机构是镍钛合金弹簧。
(4)、如第(2)项所述的系统，其中，所述恒力机构包括与凸轮面接触的弹簧。
(5)、如第(4)项所述的系统，其中，所述弹簧包括悬臂梁，该系统还包括设定点调节机构，该设定点调节机构包括沿所述悬臂梁可动地设置的可调节块体，从而调节所述悬臂梁的有效长度，并由此调节所述基本恒定的压力。
(6)、如第(2)项所述的系统，其中，所述恒力机构包括布置在腔室中并连接到活塞上的恒力弹簧。
(7)、如第(6)项所述的系统，其中，还包括设定点调节机构，该设定点调节机构包括连接到活塞上的可调节囊，该可调节囊能够通过调节所述可调节囊与所述腔室之间产生的摩擦量来调节所述基本恒定的压力。
(8)、如第(2)项所述的系统，其中，所述恒力机构包括压缩卷簧，所述流体连通腔室包括连接到所述压缩卷簧上的可膨胀的流体囊。
(9)、如第(8)项所述的系统，其中，还包括设定点调节机构，该设定点调节机构包括连接到压缩卷簧上的可膨胀的波纹管，该波纹管用于调节所述压缩卷簧的长度以调节所述基本恒定的压力。
(10)、如第(2)项所述的系统，其中，所述恒力机构包括设置在腔室内的饱和流体，该饱和流体能够与所述腔室的容量无关地保持所述基本恒定的压力。
(11)、如第(10)项所述的系统，其中，还包括设定点调节机构，该设定点调节机构用于改变饱和流体的成分以调节所述基本恒定的压力。
(12)、如第(2)项所述的系统，其中，所述恒力机构包括受到真空力的腔室。
(13)、如第(12)项所述的系统，其中，还包括设定点调节机构，该设定点调节机构用于改变作用在所述受到真空力的腔室上以调节所述基本恒定的压力。
(14)、如第(2)项所述的系统，其中，所述恒力机构包括用于有效地维持所述基本恒定的压力的渗透泵。
(15)、如第(14)项所述的系统，其中，所述渗透泵包括：
内含渗透液体并与所述限制装置流体相连通的致动腔室；以及
将致动腔室与流体腔室隔开的半透膜。
(16)、如第(15)项所述的系统，其中，所述渗透泵还包括生物所能分解的且覆盖至少一部分半透膜的塞子，该塞子能够在预定的周期内分解。
(17)、如第(14)项所述的系统，其中，所述渗透泵包括：
其内含有流体的流体腔室；
内设活塞的致动腔室；和
将所述致动腔室与所述流体腔室隔开的半透膜。
(18)、如第(1)项所述的系统，其中，所述限制装置包括能够在通路中形成限制的流体囊，并且限制量对应于流体囊中所含的流体量。
(19)、如第(1)项所述的系统，其中，还包括设定点调节机构，该设定点调节机构用于调节所述压力调节单元的基本恒定的压力。
(20)、如第(19)项所述的系统，其中，所述设定点调节机构包括可膨胀的囊和围绕该囊设置的恒压弹簧，该可膨胀的囊能够膨胀以调节所述基本恒定的压力。
(21)、如第(19)项所述的系统，其中，所述设定点调节机构包括：
杠杆，该杠杆用于施力于所述压力调节单元；和
可调支点，该可调支点连接到该杠杆上并能够沿该杠杆运动，以调节由杠杆施加的力，从而调节所述基本恒定的压力。
(22)、一种用于自动地调节限制装置的系统，包括：
流体容器；
与该流体容器流体相通的限制装置，该限制装置用于在通路中形成对应于限制装置内含的流体量的限制；和
恒力机构，该恒力机构连接到该流体容器上并用于施加基本恒定的力给所述流体容器，以保持所述限制装置中的基本恒定的压力。
(23)、如第(22)项所述的系统，其中，所述恒力机构包括恒压弹簧。
(24)、如第(22)项所述的系统，其中，所述恒力机构包括位于腔室内并连接到活塞上的弹簧。
(25)、如第(22)项所述的系统，其中，胃限制装置包括内部含有流体的流体囊。
(26)、如第(22)项所述的系统，其中，还包括设定点调节单元，该设定点调节单元连接到恒力机构上且适于改变由恒力机构施加的所述基本恒定的力。
(27)、如第(26)项所述的系统，其中，所述设定点调节单元包括可膨胀的囊。
(28)、一种用于保持在通路中的限制的方法，包括：
将限制装置植入患者体内，使得该限制装置在通路中形成对应于所述限制装置内含有的流体量的限制，该限制装置连接到压力调节单元，该压力调节单元施加基本恒定的力给在所述限制装置内的流体，以保持由所述限制装置作用于通路的基本恒定的压力。
(29)、如第(28)项所述的方法，其中，还包括使用设定点调节机构来调节所述基本恒定的压力。
(30)、如第(28)项所述的方法，其中，所述限制装置被植入患者体内，以在患者的胃中形成限制。
(31)、如第(28)项所述的方法，其中，流体流入所述限制装置内增加由所述限制装置作用在通路上的限制量。
附图说明
根据下面结合附图的详细描述可以更加充分地理解本发明，其中：
图1A是具有压力调节单元的限制系统的一种示例性的实施方式的示意图，其中压力调节单元用于控制流过系统的流体流量；
图1B是具有压力调节单元的限制系统的另一种实施方式的示意图，其中压力调节单元用于控制流过系统的流体流量；
图1C是被植入患者体内以在胃中形成限制的图1A中的胃限制系统的示意图；
图1D是图1A中的胃限制系统的胃限制装置和端口的透视图；
图2A是具有恒力机构的压力调节单元的一种示例性的实施方式的局部透明透视图，该恒力机构包括与可膨胀波纹管连接的镍钛合金弹簧；
图2B是图2A中压力调节单元的截面图；
图2C是作为镍钛合金弹簧长度的函数的力的曲线图；
图3A是具有恒力机构的压力调节单元的另一种实施方式的透视图，该恒力机构包括具有围绕其设置的螺母且与扭簧连接的螺杆传动装置；
图3B是图3A中的压力调节单元沿着B-B线的截面图；
图3C是图3A中的压力调节单元沿着C-C线的另一截面图；
图4A是具有恒力机构的压力调节单元的再一种实施方式的截面图，该恒力机构包括与凸轮面接触的恒力弹簧；
图4B是结合了具有图4A中的恒力机构的压力调节单元的限制系统的一种实施方式的截面图，显示处于第一位置的恒力机构；
图4C是图4B中的限制系统的截面图，显示处于第二位置的恒力机构；
图4D是具有与凸轮面接触的恒力弹簧的恒力机构的另一种实施方式的透视图；
图4E是具有与凸轮面相接触的恒力弹簧的恒力机构的另一种实施方式的局部透明侧视图，显示处于第一位置的恒力机构；
图4F是图4E中的恒力机构处于第二位置时的局部透明透视图；
图5是具有恒力机构的压力调节单元的另一种实施方式的截面图，该恒力机构包括与活塞连接的恒力弹簧；
图6是具有恒力机构的压力调节单元的再一种实施方式的截面图，该恒力机构包括与可膨胀流体囊连接的压缩卷簧；
图7A是根据本发明的另一种实施方式具有恒力机构的压力调节单元的截面图，该恒力机构包括设置在腔室内的饱和流体；
图7B是具有包括设置在腔室内的饱和流体的恒力机构的压力调节单元的再一种实施方式的截面图；
图8是具有恒力机构的压力调节单元的另一种实施方式的截面图，该恒力机构包括受到真空力的腔室；
图9A是具有包括渗透泵的恒力机构的压力调节单元的另一种实施方式的局部透明透视图；
图9B是用在限制系统中的压力调节单元的恒力机构的渗透泵的另一种实施方式的局部透明透视图；
图9C是用在限制系统中的压力调节单元的恒力机构的渗透泵的另一种实施方式的截面图；
图9D是连接到限制系统上的图9C中的渗透泵的透视图；
图10是显示设定点调节机构的一种示例性的实施方式的示意图。
具体实施方式
下面将对某些示例性的实施方式进行说明，以全面理解这里所公开的装置和方法的结构原理、功能、制造和使用。附图示出了这些实施方式中的一个或多个例子。本领域技术人员将会理解这里特别说明和在附图中显示的装置和方法是非限制性的示例性实施方式，并且本发明的保护范围将仅由权利要求限定。与一个示例性实施方式关联地图示或说明的特征可以与其它实施方式中的特征结合。这样的修改和变化将包括在本发明的保护范围之内。
本发明总的提出了用于调节限制系统的方法和装置。通常，这些方法和装置利用基本恒力机构来维持植入体内以在通路中形成限制的基于流体的限制装置中基本恒定的流体压力。利用这类基于流体的限制装置，装置内的流体量可以对应于施加在通路中的限制量。因此，当发生变化，例如由于患者体重减轻时，作用在限制装置上的力(也就是，与装置接触的组织)也会改变。结果是，限制装置中的压力将会改变，从而影响作用在通路中的限制量。为保持限制装置的有效性，人们期望当改变发生时，装置内保持基本恒定的平衡压力。在一种示例性的实施方式中，压力是通过机械方式且非电方式来保持，从而不需要可能必须被提供电能以在延长的时间周期内工作的任何电子元件来操作装置。另外，还可维持通路中的限制而无需检测、感测或读取特定参数，这是因为压力调节单元能够通过机械方式操作以响应于压力的改变施加基本恒定的力给流体，从而获得基本恒定的压力。
尽管这里公开的不同方法和装置可用在任何限制系统中，但以非限定例子的方式，图1A中显示了限制系统10的一种实施方式，其具有限制装置20，该限制装置用于接收流体以在通路中形成对应于其内所含的流体量的限制。系统10还包括与限制装置20相连通的压力调节单元30，用于维持限制装置20内流体的基本恒定的压力。进一步如图1A所示，系统10还可以可选地包括用于接收流体的注射端口70。注射端口70可以与限制装置20和/或压力调节单元30流体相通，以给限制装置20增加流体和/或调节压力调节单元的基本恒定的压力。可以使用使限制装置20、压力调节单元30和/或端口70之间流体相通的各种技术。在所示的实施方式中，限制装置20、压力调节单元30和端口70彼此串联且都由在它们之间延伸的导管90彼此连接在一起。在另一种实施方式中，该系统可具有Y或T形结构。例如，图1B显示导管90’具有Y形连接器91’，其第一分支部分90a’从其一端延伸并连接到限制装置20’，第二和第三分支部分90b’、90c’从其另一端延伸并分别连接到端口70’和压力调节单元30’。这种结构能够使得填充和/或调节端口70’和/或压力调节单元30’变得更加容易。本领域技术人员将会理解可以对这种特定的元件结构进行改变。另外，限制系统10、10’还可以可选地包括用于调节压力调节单元30、30’的基本恒定压力的设定点调节机构80、80’。本领域技术人员将会认识到该系统可以有许多其它的结构并可包括其它元件。例如，虽然所示的实施方式显示了端口是分离的但与压力调节单元相连通，在其他实施方式中端口和压力调节单元可位于同一腔室内，或端口可以是压力调节单元的一部分。该系统也可以可选地包括用于测量不同参数的传感器或其他元件。
图1C显示了被植入以在患者的胃100中形成限制的图1A的限制系统。在所示实施方式中，限制装置20是胃限制带，其围绕在患者的胃100的上部，然而事实上本发明可用在任何限制系统中。所示限制装置20更详细地显示在图1D中，如图所示，限制装置20具有一个大致细长的形状并具有支承结构22，支承结构22具有可以相互固定的位置相反的第一端20a和第二端20b。可使用不同的配合技术将第一端20a和第二端20b固定在一起。在所示的实施方式中，第一端20a和第二端20b的形式是配合在一起的、一个叠放在另一个上方的带子。胃束带20还可包括可变容量部件，例如可膨胀的囊24，该囊设置或形成于支承结构22的一侧上，并且设置在靠近组织处。囊24可包含数量可变的流体，该流体引起囊24抵靠着胃的外壁膨胀或收缩，形成用于可控地限制食物进入胃中的可调人造口。在使用时，胃限制装置20可围绕患者的胃-食道相接处设置。如图1C所示，限制装置20至少基本上围绕胃100靠近与食道的连接处的上部。当限制装置20(优选地在限制装置20只含有一点或不含流体时的紧缩结构中)植入后，限制装置20可利用例如生理盐水而膨胀来减小人造口开口的尺寸。本领域技术人员将会理解，不同的技术，包括这里所公开的内容，可用于最初使限制装置20膨胀和/或调节限制装置20。
本领域技术熟练人员将会认识到，胃束带可具有多种其他的结构，另外，这里公开的其他方法和装置同样适用于其他类型的限制装置。例如，在美国专利No.6461292中所介绍的，束带可用于治疗排泄系统失禁，该专利文献的内容整体并入本文作为参考。还如申请号为2003/0105385的美国专利申请中所介绍的，束带可用于治疗泌尿系统失禁，该申请文件的内容整体并入本文作为参考。此外，如在美国专利No.6470892所公开的，束带可用于治疗胃灼热和酸反流，该专利的内容整体并入本文作为参考。另外，如申请号为2003/0114729的美国专利申请中所介绍的，束带可用于治疗阳痿，该专利申请的内容整体并入本文作为参考。
还如附图1C所示，压力调节单元30以及与之连接的任一个端口70或设定调节机构80，也可被植入患者体内。可根据外科医生的需要可以改变特定的位置。一旦植入，压力调节单元30用于施加基本恒定的力给与限制装置流体相通的流体连通腔室。虽然理想的是基本恒定的力总是恒定的，在使用时，恒力机构试图得到恒定的力，但在百分百的时间内保持那个恒力方面并不是百分百地有效。相应地，本领域技术人员会理解这里所使用的术语“恒力”、“恒压”和“恒定平衡”的意思是指基本恒定的力、压力和平衡，微小的变化将会发生。在一种示例性的实施形式中，优选的是基本恒定的力保持在预设的力的10％以内。所提供的基本恒定的力可基于预设压力，即由压力调节单元30保持在限制装置20中的期望的基本恒定的力(由此在限制装置20和压力调节单元30之间维持基本恒定的平衡)。预设压力可在植入体内之前设置，优选地按照不同患者设置。许多不同的恒力机构可结合到压力调节单元30中以提供基本恒定的力。在使用时，当限制装置20内的流体压力降低到小于由压力调节单元30控制的预设压力(例如，由于患者体重降低)或增加到大于由压力调节单元30控制的预设压力(例如，由于患者体重增加)，作为响应，压力调节单元30会增加或降低限制装置20中的流体的量，直到限制装置20中的流体压力等于预设压力。更具体地，在被限制的区域，例如胃100的人造口的尺寸由于像体重降低的作用下而减小的情况下，限制装置20中的压力将会减小，因而需要增加限制装置20中的压力以保持在具有新尺寸的人造口周围有足够的压力。由于压力调节单元30用于提供基本恒定的压力给与限制装置20流体连通的流体连通腔室，当限制装置20中的压力降到低于预设压力(由基本恒定的压力限定)时，压力调节单元30将会做出响应，使流体从流体连通腔室流到限制装置20中，直到限制装置20中的流体压力再次回到预设压力。换句话说，压力调节单元30不断地在系统中由流体(即，流体连通腔室和限制装置中的流体)作用于压力调节单元30上的连续变化的力与由恒力机构作用在系统中的流体上的基本恒定的力之间尽力获得平衡。因此系统10可以控制加入到限制装置20和/或从限制装置20中排出的流体的量，从而控制由限制装置20产生的限制的量。更具体地，当流体被加入到限制装置20中时，限制增大，同样，当流体从限制装置20中排出时，限制减小。本领域技术人员将会理解，压力调节单元30不需要使用外部能量或外力来调节限制装置中的限制的大小。另外，本领域技术人员还将会理解，对限制装置20中的压力改变的补偿可以是实时的、即刻的。
可选地，压力调节单元30被设计成只有当限制装置20中的流体压力小于预设压力时，压力调节单元30才会使流体流入限制装置20中去。当限制装置20中的流体压力大于预设压力时，压力调节单元30可以不采取动作。这有利于允许压力调节装置20中的压力例如在患者进食时产生微小改变，而无需连续地改变限制装置20中的流体压力。与该方法相关的另一个优点是，某些患者可能永远不需要从限制装置去除流体，而只需要增加进入到限制装置中的流体。
图2A和2B中示出了压力调节单元130的一种示例性的实施方式。如图所示，压力调节单元130通常包括具有近端132p和远端132d的壳体132，在远端132d上形成了进入端口134。在壳体132内形成和/或设置恒力机构和流体连通腔室。在这种实施方式中，流体连通腔室采取波纹管136的形式，恒力机构采取镍钛合金弹簧140的形式，该弹簧施加恒力给传递机构，例如作用于波纹管136中的流体的活塞138。波纹管136布置在壳体132的远端132d中并包括与可连接到限制装置上的进入端口134流体相通的开口远端。波纹管136的近端可连接到壳体132内靠近波纹管136设置的活塞138上。活塞138可在壳体132内滑动并作用在波纹管136的近端以推动流体从波纹管136内部通过端口134流出。恒力机构，如所示的镍钛合金弹簧140可位于靠近活塞138处并可用来施加基本恒定的压力给活塞138。由于其镍钛合金的特性，镍钛合金弹簧140能够有效地提供恒力。特别地，如图2C所示，镍钛合金弹簧通常包括恒应力区，使得随着弹簧长度改变时，由弹簧施加的力保持恒定，直到在该应力区的任一端达到一定的长度，在该位置弹簧的力再次改变。因此，镍钛合金弹簧140可以扩张明显的量且同时仍施加大致相同的力给活塞138。
虽然图2A和图2B中作为单独的元件显示了波纹管136，活塞138和镍钛合金弹簧140，在其他实施形式中这些元件可以有选择地组合或去除，只要压力调节单元130仍维持限制装置内的基本恒定的压力。通过非限制性实施例的方式，可省去活塞138而恒力机构可直接作用于波纹管136。另外，镍钛合金弹簧140可结合在波纹管136中形成单个元件，该单个元件是可操作的以提供基本恒定的力。另外，本领域技术人员会理解，某些所示部件可以被其它类似元件替换。例如，波纹管136可以替换成能够膨胀或收缩且可与进入端口134流体相通的其他元件。另外，其他恒力机构(其中某些在这里作了介绍)可替换镍钛合金弹簧140并适用于压力调节单元130。
在使用时，镍钛合金弹簧140限定预设压力，其是由压力调节单元130在限制装置中需要保持的基本恒定的力。当限制装置中流体的压力下降至低于预设压力时，由于镍钛合金弹簧提供的基本恒定的力超过限制装置中降低的流体压力，镍钛合金弹簧140伸长将活塞138向远侧朝向波纹管136推动。活塞138向远侧的致动引起波纹管136向远侧推动，迫使波纹管136内的流体通过端口134流出并被输送到限制装置中提高其中的流体的压力。相反地，当限制装置中的流体压力上升到高于预设压力时，流体可通过端口134从限制装置中流出并进入到波纹管136中。流体流入波纹管136可引起波纹管136膨胀或朝着近侧方向移动，这继而可以朝着近侧方向移动活塞138，使镍钛合金弹簧140缩短。当限制装置中的流体压力达到预设压力时，就达到了压力调节单元130的平衡状态，并且在波纹管136和限制装置之间没有流体的流动。换句话说，当由波纹管136作用到镍钛合金弹簧140上的力(对应于限制装置内的流体压力)等于由弹簧施加给波纹管136的反作用力时，弹簧138和波纹管136将由于这些力相等而停止移动。限制装置中任何压力的改变都会导致这些力的不平衡，从而引起弹簧140和活塞138进一步的移动以使波纹管138膨胀或收缩直到重新达到平衡。本领域技术人员将理解，如上面所述，使弹簧140缩短，至少对于一定长度，不会改变由镍钛合金弹簧140作用到活塞138的基本恒定的力。本领域技术人员还将理解，尽管这里描述的不同实施形式中没有流体的流动，流体可仍然保持与限制装置和流体连通腔室(例如在所示实施方式中的波纹管136)流体相通。流体仍然保持相通以容许恒力机构能够对压力的改变做出响应，但是当达到平衡时，流体仅仅是保持停滞，没有附加的力作用在流体上以引起通过系统的运动，至少直到力的不平衡发生。图2A-2B还显示了用于调节预设压力的机构，在下面将作详细说明。
图3A-3C示出了压力调节单元230的另一种实施方式。通常，压力调节单元230包括：具有近端232p和远端232d的壳体232，在远端232d中形成了进入端口234；和包括设置在壳体内的恒力机构240。如图示，壳体232包括在远端部中形成且与限制装置通过端口234相连的流体连通腔室或容器242。恒力机构240包括轴向延伸通过壳体232的螺杆244，该螺杆包括连接到其远端的活塞245，该活塞用来施加力给容器242。螺杆242具有斜面246，例如螺杆周围形成的螺纹，螺母248可螺纹连接地布置在螺杆244的中间或近侧部分。螺母248在壳体232内可转动，但轴向固定。扭簧250布置在螺母248周围并连到螺母248上，使扭簧250能够施加在期望的方向上转动螺母248的力，由此使螺杆244在壳体232内轴向移动。螺杆244在壳体232内的轴向移动有效地使活塞245在壳体232内移动，从而增加或降低施加在流体容器242内的流体上的力。在一种优选的实施方式中，扭簧250用于施加使螺母248沿顺时针方向转动的基本恒定的力，从而施加指向远侧的力给斜面246。
在使用时，扭簧250限定预设压力。当限制装置中流体的压力下降至低于预设压力时，扭簧250使螺母248沿顺时针方向转动，这继而引起螺杆244和活塞245向远侧移动。活塞245向远侧的移动推压着流体容器，从而推动流体从容器242通过进入端口234流出并进入到限制装置中，以提高其中的流体的压力。当限制装置中的流体压力上升到预设压力时，就达到了平衡，没有进一步的压力施加给容器242和限制装置中的流体。相反地，当限制装置中的流体压力高于预设压力时，流体可从限制装置中通过进入端口234流出并进入到容器242。流体流入容器242引起活塞245向近侧移动，这继而可以使螺杆244向近侧移动，使螺母248沿相反方向转动，释放由螺母施加给扭簧250的张力。活塞245和螺杆244将继续向近侧移动，直到由限制装置中的流体压力施加给活塞245和螺杆244的力等于通过作用在螺母248上的扭簧250施加给活塞245和螺杆244的力相等。相应地，恒力机构240将连续地响应流体容器242内的流体的压力变化(对应于与流体容器相通的限制装置内的流体的压力变化)，以由此维持预设压力。图3A还显示了连接到压力调节单元230的端口270，该端口用于调节恒力机构的基本恒定的力，如在下面将作详细说明。
尽管到现在已经对两种不同类型的恒力机构进行了深入讨论，还有其它类型的很多恒力机构可结合到压力调节单元中以保持与在限制装置流体相通的流体源上的预设压力。这些恒力机构中的某些将在下面详细说明，而其他恒力机构是在本领域中已知的且可结合到限制系统中去。
图4A显示了用在压力调节单元中的恒力机构340的另一种示例性的实施方式。如图所示，恒力机构340包括可滑动地设置在滑动面346上的块体344。在所示的实施方式中，块体344包括位于块体344底面上的、适于沿滑动面346滑动的多个滚子354。但是块体344还可有使块体344能够沿滑动面346滑动的其他结构。另外还显示出块体344具有在其上形成的凸轮面348，弹簧350与块体344的凸轮面348接触。虽然在所示实施方式中凸轮面348基本上是平直的，但在其它实施形式中凸轮面348可以是倾斜的或弯曲的。弹簧350可具有不同的结构，但在一种示例性的实施形式中，该弹簧用于施加向下的力FS给凸轮面348。法向力FN1可用于保持向下的力FS的水平位置，例如通过将直线滑块或其它提供法向力的物体放置到弹簧350上。由弹簧350施加在凸轮面348上的力产生了作用在块体344上的基本恒定的力F，如沿x轴所示的那样。
像图4A所示的恒力机构340那样的恒力机构可容易地结合到限制系统310’中，如图4B、4C所示。在这种实施形式中，恒力机构340’包括可滑动地设置在滑动面346’上的块体344’。块体344’具有在它上面形成的凸轮面348’，以及悬臂梁352’与块体344’的凸轮面348’。虽然不是必要的，悬臂梁352’可包括在其末端形成的支承元件350’，该支承元件用于支承抵靠在凸轮面348’上，从而容许悬臂梁352’沿着凸轮面348’运动。在这种实施形式中，块体344’用于沿着滑动面346’滑动而无需滚子的辅助，虽然也可以使用滚子或其它类似装置。块体344’可根据作用在块体344’上的基本恒定的力F’和通过与限制装置流体相通的流体作用在块体344’上的力FF’做出响应而发生运动。尽管可使用不同的技术来实现在恒力机构340’和限制装置之间的流体相通，在所示实施形式中，系统310’包括流体连通腔室，例如在壳体371’内部形成的并与限制装置320’流体相通的流体容器370’。活塞372’连接到块体344’上并布置在流体容器370’内部。活塞372’用于随着块体344’沿着滑动面346’滑动而在流体容器内滑动。
在使用时，悬臂梁352’限定与期望的预设压力对应的基本恒定的力。当限制装置320’中流体的压力下降到低于预设压力时，由悬臂梁352’作用在块体344’上的基本恒定的力F’将超过由流体(通过活塞372’)作用在块体344’上的力FF’，因此悬臂梁352’使块体344’向右移动，如图4C所示。块体344’向右移动使与其连接的活塞372’同样向右移动，这继而推动流体从流体容器370’流入到限制装置320’中，以提高其中的流体的压力。当限制装置320’中的流体压力达到基本恒定压力时，就达到了平衡且不再有移动发生。相反地，当限制装置320’中的流体压力升高到高于预设压力时，流体可从限制装置320’中流入到流体容器370’，并可将活塞向左移动，如图4B所示，这继而可引起块体344’向左移动，直到限制装置320’中的压力降低至与预设压力相等的压力。图4B-4D还显示了用于调节预设压力的机构，下面将作详细说明。
图4E和4F示出了具有与凸轮面348”接触的弹簧350”的恒力机构340”的另一种实施方式。恒力机构340”具有可调节的悬臂装置344”，该悬臂装置可滑动地连接到滑动面346”。可调节的悬臂装置344”包括悬臂梁345”，该悬臂梁在其上方形成凸轮面348”。悬臂梁345”可以是设成固定地，但也可选地设成可调地连接在基座345b”上。可调节悬臂装置344”还可包括弹簧350”，该弹簧用于给悬臂梁345”施加作用力，从而引起梁345”(连同与其相连的基座345b”)左右移动。在所示实施方式中，弹簧350”沿着横向于梁345”延伸的臂346a”伸长。弹簧350”包括固定连接到臂346a”的基座346b”上的第一端，以及与支承元件352”配合的第二端。支承元件352”沿着臂346a”的一段长度可移动地安装，且可滑动地设置在臂345”的凸轮面348”上。在使用时，弹簧350”通过支承元件352”施加作用力给梁345”。该力可引起梁345”和与梁345”配合的基座346b”沿着位于与臂346a”配合的基座346b”上的滑动面346”滑动，如图4E和4F所示。随着臂345”滑动，支承元件352”相对臂346a”上下移动，这是由倾斜的凸轮面348”及弹簧350”作用在支承元件352”上的力而引起的。因此，与图4A中所示的恒力机构340类似，由可调悬臂装置344”作用在梁345”上的法向力会产生基本恒定的力F”。基本恒定的力F”会提供基本恒定的压力，即预设压力，给限制系统中的流体。本领域技术人员将会理解，图4E和4F中所示的恒力机构340”可以很容易的结合到各种的限制系统中，例如图4B和4C中所示的限制系统310’中，其结合方式与上述的图4A中的恒力机构340的实施例结合到图4B和4C所示的限制系统310’中的方式很类似。另外，本领域技术人员将会理解，在使用时图4E和4F中所示的恒力机构340”限定预设压力，因此以与上面所描述的图4A中的关于恒力机构340的方式相类似的方式进行操作。
图5显示了其内具有恒力机构的压力调节单元440的另一种实施方式。如图所示，通常，压力调节单元440包括具有近端442p和远端442d的腔室或壳体442。壳体442包括设置在近端442p的恒力弹簧446，和设置在远端且连接到恒力弹簧446上的活塞452。在一种示例性的实施方式中，恒力弹簧446的一部分展开且沿着壳体442的一部分设置，弹簧的终端固定到壳体442上。壳体442中可包括邻近展开部分形成的狭槽，从而容许恒力弹簧446的卷曲部分相对其展开部分卷曲或展开。这使得卷曲部分及其与之连接的活塞452可以在壳体442内向远侧和近侧移动。由于恒力弹簧446被偏压成卷曲构型，弹簧446将施加指向远侧的恒力给活塞452，从而施加一个恒力给位于活塞452远侧的并例如通过在壳体442上形成的端口442p与限制装置流体相通的流体容器450。可选地，壳体442也可包括布置在其中并与活塞452相连的可膨胀的囊448，用于调节恒力机构的恒力，下面将进行详细说明。
在使用时，恒力弹簧446限定预设压力。当限制装置中流体的压力下降至低于预设压力时，由于基本恒定的压力超过限制装置中降低的流体压力，因此恒力弹簧446卷曲，推动活塞452向远侧移动进入到流体容器450中。其结果是，流体被推动从流体容器450通过端口442p流出并进入到限制装置中，以提高其中的流体的压力。当限制装置中的流体压力达到基本恒定的压力时就达到了平衡，没有流体在流体容器450和限制装置之间流动。相反地，当限制装置中的流体压力高于预设压力时，流体可从限制装置中通过端口442p流出进入到流体容器450。流体流入流体容器450引起活塞向近侧移动，从而恒力弹簧446的卷曲部分向近侧移动，从而进一步展开。限制装置中的压力会下降直到预设压力，在此刻没有流体在流体容器450和限制装置之间流动。
图6显示了包括压力调节单元的另一种实施方式，该压力调节单元包括具有近端542p和远端542d的壳体542和在壳体的远端542d中形成的进入端口544。第一流体囊，例如第一波纹管546，布置在壳体542的远端542d中并连接到弹簧548上。弹簧548可在第一波纹管546和第二波纹管550之间延伸，这两个波纹管可用于调节弹簧的恒力，下面将作详细说明；或者，可选地，去掉第二波纹管550，弹簧548的近端可连接在壳体542的近端。第一波纹管546与进入端口544流体相通，该进入端口可与限制装置流体相通。第一波纹管546可根据其中的流体的量进行膨胀和收缩(也就是说响应限制装置的压力变化)。弹簧548可具有不同的结构，但在一种示例性的实施方式中，弹簧548是卷簧，该卷簧被偏压到伸长位置，以提供基本恒定的力给波纹管546，从而推动其中的流体从第一波纹管546内部经过端口544流出并进入到与之相连的限制装置中。
在使用时，弹簧548限定预设压力。当限制装置中流体的压力下降到低于预设压力界限时，由弹簧548作用在波纹管546上的力将超过波纹管546中的与限制装置流体相通的流体作用在波纹管546上的力。因此，弹簧548将伸长以压缩波纹管546。这将引起其中的流体通过端口544离开波纹管546并进入到限制装置中，提高其中的流体压力。当限制装置中的流体压力上升到预设压力时就达到了平衡，弹簧548不再伸长，而波纹管546不再被压缩。相反地，当限制装置中的流体压力高于预设压力时，波纹管546可膨胀接收来自流体容器的流体，从而降低限制装置中的流体压力。弹簧548响应于限制装置中的流体压力的变化持续作用在波纹管546上，以保持限制装置中的基本恒定的压力，即预设压力。
图7A、7B显示了其内具有恒力机构的压力调节单元640、640’的另外两种实施方式。每个压力调节单元640、640’通常包括含有饱和流体646、646’的壳体或腔室642、642’，以及包括用于施加作用力给例如通过端口644、644’与限制装置流体相通的流体容器的传递机构。饱和流体646、646’可以是任意种液体或气体，但是在一种实施方式中，饱和流体646、646’可以是杜邦公司的Dymel溶胶推进剂或丁烷。在图7A的实施方式中，传递机构是位于腔体642内的第一活塞648，该第一活塞648与设在流体连通腔或容器670中的第二活塞650相连。随着腔体642内的饱和流体646增加，第一活塞648向右移动，从而将第二活塞650向右移动，推动一部分流体从流体容器670中流出并通过端口644，增加限制装置中的流体压力。在图7B的实施方式中，传递机构是柔性囊671’，该柔性囊布置在腔体642’内并在其内具有与限制装置流体相通的流体容器670’。
在使用时，饱和流体646、646’限定预设压力。当限制装置中流体的压力下降到低于预设压力限制时，传递机构推动流体从流体容器670、670’中流出并进入到限制装置中，提高其中的流体的压力。因此，在图7A所示的实施方式中，限制装置中的流体压力降低将导致基本恒定的压力推动第一活塞648向右移动，从而推动设在流体容器670中的第二活塞650向右移动，推动流体从流体容器670中通过进入端口644流出并进入到限制装置中。在图7B所示的实施形式中，限制装置中的流体压力降低导致基本恒定的压力压迫位于其中的囊671’，推动流体从流体容器670’中通过进入端口644’流出并进入到限制装置中。当限制装置中的流体压力达到基本恒定的压力时，就获得了平衡，没有流体在容器670、670’和限制装置之间流动。相反地，当限制装置中的流体压力高于预设压力时，流体可从限制装置中通过进入端口644、644’流出并进入到容器670和670’中。流体流入流体容器670和670’可引起流体容器670和670’容量增大，从而使含有饱和液体646、646’的腔室642、642’的容量减缩。通过使流体流入流体容器670和670’，限制装置中的压力可降低直到达到预设压力，在这一刻没有流体在流体容器670、670’和限制装置之间流动。
用在压力调节单元中的恒力机构740的另一实施方式如图8所示。如图所示，恒力机构740通常包括具有真空体积744的腔室或壳体742，该真空体积也被称为负压或真空腔室。活塞746至少部分地布置在壳体742内，流体连通腔室，例如容器750连接到活塞746上并与限制装置例如通过进入端口751流体相通。壳体742适于接受力来作用在活塞746上，因此抵抗真空体积744的作用。在一种实施方式中，壳体742包括穿过壳体的开口748，该开口有效地接受与体积无关的基本恒定的压力，例如空气压力来作用在活塞746上。由于真空体积位于活塞746的下方，空气压力产生的力独立于活塞746的移动被提供。相应地，与图7A和7B包括了饱和流体646、646’的实施方式类似，该恒力机构740可在一定的体积范围内独立于体积地保持基本恒定的压力。相应地，所产生的基本恒定的压力可被用作预设压力。
在使用时，真空体积744限定预设压力。当限制装置中流体的压力下降到低于预设压力限制时，活塞746沿所示向下的方向移动，以使容器750中的流体通过端口751流到限制装置中。当限制装置中的流体压力达到基本恒定的压力时，就获得了平衡，没有流体在容器750和限制装置之间流动。相反地，当限制装置中的流体压力高于预设压力时，流体可从限制装置中流出并进入到容器750中。流体流入流体容器750可引起活塞746沿所示向上的方向移动。通过容许流体流入容器750，限制装置中的压力可降低直到达到预设压力，在这一刻没有流体在流体容器750和限制装置之间流动。
图9A-9D显示了其内具有恒力机构的压力调节单元的另外的实施方式。在这些实施方式中，恒力机构是渗透泵。在图9A的实施方式中，渗透泵840通常包括具有近端842p和远端842d的壳体842，壳体的近端842p具有于其中形成的半透膜846，远端842d具有于其中形成的进入端口844。半透膜846可适于允许流体流进和流出壳体842，同时将壳体842中的流体内溶解的物质对外部环境密封。在一种实施方式中，半透膜846由醋酸纤维素制成。壳体842还可包括渗透腔室848(有时称为渗透引擎)，腔室内含有渗透物质，例如类似生理盐水的溶液，该渗透腔室与半透膜846流体相通。在一种示例性的实施方式中，在通过半透膜846接收任何流体之前，渗透物质可布置在渗透腔848中。活塞845可滑动地布置在壳体842内部并与渗透腔848流体相通，以接受由渗透腔室848内的渗透压力产生的基本恒定的力，该渗透压力可以由在渗透腔848内半透膜846相反两侧溶解的物质的浓度差而产生。活塞850的滑动可将产生的基本恒定的力作用在壳体842中位于活塞850的远侧处的流体852，从而推动流体852从壳体842通过进入端口844流到限制装置中。另外，可选地，可生物降解的塞子854可在近端842p处连接到半透膜846上，用于延缓通过半透膜846的液体和/或进入到渗透腔848中的流体流动。可生物降解的塞子可由能够延缓流体流动的各种材料制成，但是在一种实施方式中，塞子854由聚乳酸(polyactide)和聚乙醇酸交酯(polyglycolide)制成。另外，塞子854的尺寸和形状可根据所需要的延缓而变化。可选地，渗透泵840还可连接到端口870上，该端口在所示实施方式中可用于直接地给系统增加流体。端口870相对于渗透泵840的位置可以改变，但在所示实施方式中端口870位于渗透泵840上方。在图9B所示的另一种实施方式中，端口870’可位于靠近渗透泵840’并基本成一条线的位置。同样，渗透泵和端口之间也可能有其它结构，正如渗透泵元件的其他结构也是可能的。例如，在结合了可生物降解的塞子854的实施形式中，塞子854可布置在渗透泵840内可有效地延缓流体流动的任何位置，例如位于壳体842内靠近端口844的位置。
在使用时，在渗透泵840的渗透腔室848内的渗透压力限定预设压力，该渗透压力可通过半透膜846相反两侧溶解物质的浓度差而产生。当限制装置中流体的压力下降至低于预设压力时，渗透腔848中的压力也降低，流体受驱穿过渗透膜846，越过渗透势并进入到渗透腔848内，推动活塞850朝向端口844向远侧移动，这是由于渗透泵840提供的基本恒定压力超过限制装置中流体降低后的压力。活塞850向远侧的致动可使位于活塞远侧的流体852被推向远侧，通过进入端口844并进入限制装置中，从而提高其中流体的压力。当限制装置中的流体压力达到基本恒定的压力时，就获得了平衡状态，此时，限制装置和渗透腔848的压力等于渗透压力，没有流体在渗透泵840和限制装置之间流动。相反地，当限制装置中的流体压力高于预设压力时流体可从限制装置中经端口844流出并进入到壳体842的远端。流体流入壳体842的远端可引起活塞850被推向近侧，渗透腔848中的流体可被迫向近侧方向穿过半透膜846。通过容许流体流入壳体842，限制装置中的压力可降低直到达到预设压力，在这一刻没有流体在渗透泵840和限制装置之间流动。在一种示例性的实施方式中，流体是水。
在另一种实施方式中，渗透泵840可用于在初始时或在植入人体后的晚些时候填充限制装置。更具体地，在限制装置和压力调节单元被植入患者体内后，流体可流过半透膜846并进入渗透腔848中以被反应，从而产生上述基本恒定的力。包括可生物降解的塞子854可有效地延迟流体从渗透泵840的外侧穿过半透膜846进入渗透腔848的时间。当流体试图流进渗透腔848时，可生物降解的塞子将阻止此类进入，但当流体侵蚀了可生物降解的塞子854、854’时，如上所述流体可缓慢地进入到渗透腔848中并发生反应。一旦可生物降解的塞子854基本被侵蚀掉，渗透泵840就可基本上如上述地操作。在一种示例性的实施方式中，可生物降解的塞子854可以适于在4周内分解，从而逐渐充满渗透装置。
图9C和图9D显示了渗透泵840”的另一种实施方式。如图所示，渗透泵840”总体上包括具有近端842p”和远端842d”的壳体842”，远端842d”上形成有进入端口844”，该端口连接到限制装置820”。与图9A中渗透泵840的实施方式类似，壳体842”可包括渗透腔848”，但在这种实施方式中，渗透腔848”位于壳体842”的远端842d”中，并连接到进入端口844”上。因此，来自渗透腔848”的流体流过进入端口844”并进入到限制装置。流体腔室856”和半透膜846”同样可布置在壳体842”内。如图所示，流体通路858”可从流体腔室856”延伸到渗透腔室848”，半透膜846”布置在流体通路858”中并适于允许流体从流体腔室856”到渗透腔室848”双向地流动，从而将渗透腔室848”中的流体内含有的溶解物质对流体腔室856”密封。多个衬垫860”可布置在半透膜846”的两侧，以在流体腔室856”与渗透腔848”之间提供进一步的密闭。从流体腔室856”通过通路858”进入到渗透腔室848”中的流体可以是适于流动越过渗透势梯度并进入到渗透腔室848”的任意种物质。在一种实施形式中，流体是水。在另一种实施形式中，渗透腔室可以是人体，流体852”可以是来源于体液的水，因此，在这样一种实施形式中，半透膜846”被布置在人体内，并适于接收进入渗透腔室848”的体液。
出于制造的目的，壳体842”可由两个部件841”和843”构成，第一部件841”包含渗透腔室848”，第二部件843”包含渗透泵840”的剩余元件。虽然两部件841”、843”可用多种不同的方法连在一起，但在一种实施方式中它们被螺纹连接。另外，如图所示，通过将部件843”和841”连在一起，压缩弹簧可作用在衬垫860”上。通过在内部设置弹簧862”，该力可得到加强，从而有效地将衬垫860”压靠在半透膜846”上，来提供半透膜的适当密封。另外，为帮助保持流体通路858”的整体性，多个O型圈864”可围绕诸如弹簧862”和衬垫860”这样的元件布置，从而保持期望的位置。与渗透泵840、840’类似，渗透泵840”可选地可连接到端口870”上，该端口可用于改变预设压力和/或给系统810”增加流体，如在下面所详细说明的。
尽管这里描述的压力调节单元通常适于产生基本恒定的力，并且可用于根据预设压力(即，通过维持基本恒定压力)调节容器和限制装置之间的流体流动量，但是一旦压力调节单元已被植入体内，仍可能希望改变压力调节单元的预设压力。如上所述，通常，预设压力可先于植入人体进行设置，优选地根据不同患者进行设置。但是由于患者身体构造的变化，常常出现初始的预设压力不再是特定的患者的适当预设压力。为设定一个新的预设压力，压力调节单元可从患者体内移出，重新矫正后再次植入患者体内，但是优选地，此类调节可非侵入式地进行。相应地，不同的方法和装置可用于调节预设压力，优选是借助还要植入在人体内的系统。通常，设有设定点调节机构容许压力调节单元的预设压力非侵入式地改变。这里描述了不同类型的设定点调节机构。本领域技术人员将认识到，这里所描述的实施形式中一些主要适合于特定的实施形式或压力调节单元，而其它实施形式可用在大多数压力调节单元上。相应地，关于特定的压力调节单元所讨论的特定的压力设定点调节机构也可与其它压力调节单元共同使用。
在图2A和2B所示的设定点调节机构180的一种实施形式中，壳体182具有可膨胀件184和设置在其中的偏压机构。可膨胀件184可具有多种结构，例如可膨胀囊或流体囊。该偏压机构也可具有多种不同的结构，但在所示实施形式中，偏压机构是围绕可膨胀件184至少一部分的轴向布置的镍钛合金弹簧186。如关于图2A和2B的镍钛合金弹簧140所述，镍钛合金具有特殊属性，该属性使之成为用于在弹簧给定长度内施加基本恒定的力的系统中的理想材料。相应地，镍钛合金弹簧186可被调至特定的设定点调节压力，从而设定点调节机构是可操作的以将压力调节单元130的预设压力从初始预设压力改变为调节后的预设压力，初始预设压力限定，而调节后的预设压力是通过结合预设压力和设定点调节压力来限定。另外，适于接收探针或其他流体输送装置的隔膜188可布置在壳体182的近端182p，该隔膜可邻近可膨胀件184布置，使得穿过隔膜188的流体输送装置可将流体输送到可膨胀件184中并使其膨胀。在一种实施方式中，隔膜188是自密封的，这可允许探针刺穿隔膜188而不在隔膜188上留有开口。在壳体182的远端182d上可布置排出端口190，该端口可用于容许流体在可膨胀件184和压力调节单元130间流动。压力调节单元130可具有多种不同的机构形式，这些机构用于接收来自设定点调节机构180的流体，从而调节通过来自设定点调节机构180的流体流动产生的作用在波纹管136上的次级力。例如，活塞可布置在镍钛合金弹簧140的近端，或活塞可与波纹管136配合或形成于波纹管136上。
在使用时，选择性地与作用在波纹管136上的次级力相结合，镍钛合金弹簧186限定设定点调节压力。设定点调节压力是在通过镍钛合金弹簧186的基本恒定压力使流体从可膨胀件184中流出，通过排出端口190并进入到压力调节单元130时的压力。可选地，流体可被推动从压力调节单元130进入到可膨胀件184中，以去除作用在波纹管136上的次级力。为了通过增加从设定点调节机构180进入到压力调节单元130中的流体来获得设定点调节压力，流体可通过隔膜188加入到可膨胀件184中使膨胀件184膨胀。在一种实施方式中，在通过隔膜接收流体之前，可膨胀件184接近全空并处于紧缩状态。随着流体被加入到可膨胀件184中，可膨胀件184的体积增大，可膨胀件184最终与镍钛合金弹簧接触并使之伸长。但是，因为弹簧186由镍钛合金制成，弹簧186提供的力随着弹簧186的伸长不会改变，因此该力保持基本恒定。流体可继续加入到可膨胀件184中，直到达到设定点调节压力，在这一刻，镍钛合金弹簧186驱使流体从可膨胀件184通过排出端口190并进入到压力调节单元130中。在所示实施方式中，当流体进入到压力调节单元130，次级力作用于波纹管136并与由镍钛合金弹簧140产生的压力相结合，产生调节后的设定压力。相应地，向压力调节单元130中加入流体可将预设压力从初始预设压力改变为调节后的预设压力，初始预设压力就是仅由镍钛合金弹簧140产生的压力，而调节后的预设压力就是由镍钛合金弹簧140和作用在波纹管136上的次级力产生的压力。可选地，产生作用在波纹管136上的次级力的流体可通过穿过隔膜188移除流体以使可膨胀件184紧缩的方式从压力调节单元130移除并进入到设定点调节机构180。相应地，从压力调节单元130中移除流体可将预设压力从调节后的预设压力，即由镍钛合金弹簧140和作用在波纹管136上的次级力产生的压力，改变为初始设定压力，即仅由镍钛合金弹簧140产生的压力。设定点调节机构的设定点调节压力可在不同患者间变化，因此在获得设定点调节压力之前布置在可膨胀件184中的流体的量也可根据患者而改变。但是在一种实施方式中，可膨胀件184可以膨胀，使得基本上在壳体182内所有可用空间被内有流体的可膨胀件184填充。当再没有空间膨胀时，就可获得设定点调节压力，并且流体可从可膨胀件184流过排出端口190并进入到压力调节单元130。
在另一种实施方式中，如图3A-3C所示，可通过改变卷簧250的张力来调节压力调节机构230的预设压力。例如，壳体232可包括连接在壳体上用于接收流体的端口270(图3A)。连接器260可在端口270和壳体232之间延伸，且可包括可移动地设置在其内的塞子254，该塞子连接到可转动地设置在壳体232内的可转动壳体258上。例如细绳256或其他部件在塞子254和壳体258之间延伸。卷簧250的一终端252可连接在可转动壳体232上。其结果是，在端口270和连接器260中增加或移除流体将引起塞子254相应地移动，从而引起可转动壳体258的转动。其结果是，卷簧250将随着壳体258卷起或展开，因此调节卷簧250的张力。
在另一种实施方式中，如图4A所示，预设压力可通过改变恒力机构的基本恒定的力F来调节。至少因为基本恒定的力F可限定预设压力，有助于产生基本恒定的力F的对恒力机构的任何调节可以有效地调节预设压力。这例如在图4B和4C中示出了。改变通过悬臂梁352’作用在支承元件350’上的力，可有效地改变预设压力，这是因为它们共同限定预设压力。如图所示，杠杆356’相对悬臂梁352’可滑动地设置并能够通过滑过悬臂梁352’的预定部分来改变悬臂梁352’的有效长度。改变悬臂梁352’的有效长度可改变由悬臂梁352’作用在支承元件350’上的法向力，从而产生了改变了的基本恒定的力F’。在一种实施方式中，杠杆356’可连接到可滑动的块体358’上，而可滑动的块体358’可连接到提供直线运动的装置上。在所示的实施形式中，提供直线运动的装置是流体系统，在该系统中，块体358’设置在流体腔室360’中，该流体腔室用于接收流体，以使块体358’在流体腔360’中滑动，从而使连接于其上的杠杆356’滑动。在使用时，随着流体加入到流体腔室360’或从流体腔室360’中移除，可滑动的块体358’进而杠杆356’可在第一位置(如图4B所示)和第二位置(如图4C所示)之间移动，在第一位置上，杠杆356’与悬臂梁352’隔开或脱离接触，而在第二位置上，杠杆356’向前滑过悬臂梁352’的一部分来缩短悬臂梁352’的有效长度，从而增加由悬臂梁352’施加的基本恒定的力F’。如图4C所示，当杠杆356’向前滑动到悬臂梁352’上来改变基本恒定的力F’时，悬臂梁352’偏斜，从而降低其有效长度，并导致基本恒定的力F’增加。
图4D显示了恒力机构340”’与图4B和4C中的恒力机构340’类似的另一种实施方式，其该恒力机构340”’也可被结合到与图4B和4C的限制系统类似的限制系统中。在这种实施方式中，恒力机构340”’包括夹持机构356”’，其用于调节悬臂梁352”’的有效长度。夹持机构356”’可以是可滑动地围绕悬臂梁352”’和连接到悬臂梁352”’的一端上的基座358”’布置。当夹持机构356”’沿悬臂梁352”’和基座358”’朝向凸轮面348”’滑动时，悬臂梁352”’被拉向基座358”’，其结果是减小了悬臂梁352”’的有效长度，从而降低了基本恒定的力F”’的值。
在另一种实施形式中，如图4E和4F中所示，可通过改变弹簧350”的张力来调节基本恒定的力F”。特别地，可增加或降低梁345”的高度来改变弹簧350”上的张力。如图所示，悬臂梁345”的近端345p”可以可枢转地连接到位于基座345b”上的侧臂上，转动元件356”可紧邻地布置在梁345”下方，因此转动元件356”的转动调节了梁345”的高度。连杆358”可布置在转动元件356”和悬臂梁345”之间，帮助传递转动元件356”的运动给悬臂梁345”。在使用时，转动元件356”的转动抬高或降低悬臂梁345”，从而改变了凸轮面348的角度θ”，同时增加或降低弹簧350”的张力，以调节基本恒定的力F”。如图所示，转动元件356”的顺时针转动降低悬臂梁345并由此降低基本恒定的力F的值，而转动元件356”的逆时针转动抬高悬臂梁345”并由此增加基本恒定的力F”的值。
在另一种实施方式中，可利用摩擦改变图5中压力调节单元440的预设压力。例如，活塞452可包括与之相连的、并与端口470相连通的可膨胀的囊448。通过端口470向囊448中加入流体会增大可膨胀囊448的体积。随着可膨胀囊448膨胀抵靠在壳体442上，可膨胀囊448与壳体之间的摩擦增大。摩擦影响活塞452移动的能力，从而改变了预设压力。
图6中所示的压力调节单元540同样可改变其预设压力。如前面所述，压力调节单元540可包括连接在弹簧548近端的第二波纹管550。第二波纹管550可连接到在壳体542的近端542p中的第二进入端口552上。为调节预设压力，流体可加入到第二波纹管550或从第二波纹管550移除，以调节与之相连的弹簧548的长度，由于弹簧548限定预设压力，当其长度改变时，预设压力也随之改变。
图7A和7B中的实施形式的预设压力也可被调节。在一种实施形式中，饱和流体646、646’的成分可以改变。在另一种实施方式中，饱和流体646、646’的浓度可以改变。虽然没有示出，这两种作用的任何一种都可通过如下方式来完成：将一端口与含有饱和流体646、646’的腔室642、642’相连，从而可以通过在腔室642、642’中加入或排出流体来改变饱和流体的成分/浓度。当饱和流体646、646’的成分/浓度成分改变时，压力调节单元640、640’的预设压力也会改变，至少是因为饱和流体646、646’限定预设压力。
类似地，图8中所示实施形式的预设压力也可通过改变真空体积744的负压而调节，因为真空体积744限定预设压力。虽然没有示出，通过将一端口与腔室742连接来进入真空体积744也可以完成上述调节。
图9A-9D中渗透泵840、840’、840”的预设压力也可通过多种方式改变，但至少是因为渗透腔室848、848’、848”中的渗透压力限定预设压力，渗透腔室848、848’、848”中流体内的溶解物质的浓度的变化也会影响预设压力。例如，改变渗透腔室中含有的渗透流体的摩尔浓度也可有效地改变预设压力。与渗透腔室848、848’、848”相连通的端口870、870’、870”可以非侵入方式有效地改变渗透溶液的摩尔浓度。
图10示出了设定点调节机构980的再一种实施方式。通常，这里说明的每个压力调节单元都包括了恒力机构。每个恒力机构(在图10中整个用恒力机构930表示)提供基本恒定的力F。虽然这里所公开的许多设定点调节机构教导了调节恒力机构或压力调节单元单个元件的方法，设定点调节机构980通常可应用在公开的每种实施方式中，因为一旦它离开恒力机构930并与另一元件相连，例如与限定装置920相通的流体容器970，它就有效地调节基本恒定的力F。用于将恒定的力F从恒力机构930传递给流体容器970的装置可布置于两者之间，在所示实施形式中，该装置是具有活塞984的杠杆982，该活塞984连接在杠杆的一端上并适于根据恒力机构930产生的基本恒定的力F，推动流体从流体容器970进入限制装置920。支点986可连接到杠杆982上，并且该支点可以是能够相对杠杆982移动来调节杠杆982的支点位置P。虽然支点986可以多种方式移动，但如图所示，它是可滑动地连接到表面988上。流体端口990可通过传递机构992与支点986流体相通，并且适于引起支点986沿着表面988且相对于杠杆982移动，以改变支点位置P。特别地，当流体被加入到端口990或从端口990移除并被输送到流体传递机构992时，布置在流体传递机构992中且和支点986相连的活塞移动，从而使支点986滑动。支点位置P的改变随后调节了系统的机械效益，从而改变了实际作用在流体容器970上的基本恒定的力F的大小。虽然支点位置P的最优位置有赖于许多因素，包括作用在杠杆982各个部分上的力的大小，但在作用在杠杆982两侧的力相等的实施形式中，支点位置P的最佳位置就是杠杆982的中点。当支点位置P处于最佳位置时，最大的基本恒定的力F就被传递给流体容器970。然而，由于系统不是恒定的或静态的，最佳的支点位置P通常在不断改变，这又意味着支点986应当不断移动以保持期望的系统效率。
在使用时，当流体从端口990加入到支点986时，支点986向左移动，根据最佳支点位置，传递给流体容器970的基本恒定的力F增大或减小。当流体然后从支点986移除时，支点986向后移动，同样依赖于最佳支点位置，传递给流体容器970的基本恒定的力F增大或减小。在实践中，最佳支点位置P随着系统的操作很可能会是不固定的，因此可有选择地增加流体到支点986或从支点986移除流体以从期望位置获得期望的效果。
在任何压力调节单元、恒力机构和设定点调节机构包括弹簧或其他可调节的机械元件以产生不同的尺寸或属性(例如弹簧属性)的程度上，本领域技术人员将会理解，许多属性和尺寸的改变将影响相应的压力调节单元、恒力机构和设定点调节机构的性能。相应地，即使上面没有讨论这些类型元件的改变，这些变化也可被结合到许多压力调节单元、恒力机构和设定点调节机构中以影响各自的期望性能。
本领域技术人员将会理解，本发明可用在传统的内窥镜和开放式外科仪器以及机器人辅助外科设备中。
这里所公开的装置可以是一次性使用的，也可以设计成多次使用。然而，在每种情况下，在至少一次使用之后，该装置可被修复以重新使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地，该装置可以被拆卸，任何数量的特定部件或零件可以有选择地以任意组合被更换或去除。在清洗和/或替换特定部件之后，该装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
优选地，这里描述的发明在外科手术之前处理。首先，获得新的或使用过的装置，如果需要的话进行对其清洗。然后，可对该装置进行消毒。在一种消毒技术中，该装置被放置在封闭和密封的容器内，例如塑料袋或高密度聚乙烯合成纸袋中。该容器和装置然后被放置到能够穿透容器的放射场中，例如伽玛射线，X射线，或高能电子。放射线将杀死仪器表面和容器内的细菌。消毒后的装置可以被储藏在无菌容器中。该密封的容器会保持装置无菌，直到它在医疗设备中被打开。
优选地，该装置是消过毒的。这可以通过多种本领域技术人员已知的任意种方式，例如贝塔或伽玛射线，环氧乙烷，蒸汽来实现。
基于上述实施方式，本领域技术人员将会理解本发明的其它特征和优点。相应地，本发明的保护范围不是通过具体描述或显示的内容进行限定，而是通过所附权利要求来限定。这里所引用的所有的公开内容和参考文献在这里以引用的方式被整体地结合。
Claims (2)
1.一种自调节限制系统，包括：
用于在通路中形成限制的限制装置；和
与限制装置相通的压力调节单元，该压力调节单元通过调节限制装置中的流体量，有效地在限制装置与压力调节单元之间保持基本恒定的平衡压力，该压力调节单元具有恒力机构和与该限制装置流体连通的可膨胀的波纹管；以及
设定点调节机构，该设定点调节机构包括能够膨胀以调节所述平衡压力的可膨胀囊，以及围绕该可膨胀囊布置的恒力弹簧。
2.如权利要求1所述的系统，其中，所述恒力机构是镍钛合金弹簧。
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| GB1084079A (zh) | 1964-11-30 | Beckman Instruments Inc | ||
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| CH529567A4 (zh) | 1967-04-14 | 1969-12-31 | ||
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| US3581774A (en) * | 1969-04-01 | 1971-06-01 | Us Navy | Constant pressure accumulator |
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| BE759990A (fr) | 1969-12-17 | 1971-05-17 | Sauter Kg August | Corde de mesure vibrant a plat, notamment pour balances a cordevibrant |
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| US3781902A (en) | 1971-09-07 | 1973-12-25 | Nasa | Recorder/processor apparatus |
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| GB1382191A (en) | 1972-03-08 | 1975-01-29 | Doncaster Sons Ltd Daniel | Hydraulic jacking devices |
| AU5340573A (en) | 1972-03-16 | 1974-09-19 | Griffin C J | Load indicating assembly |
| US3857745A (en) | 1972-04-18 | 1974-12-31 | Fisher & Paykel | Method of covering articles with leather |
| US3765494A (en) | 1972-04-21 | 1973-10-16 | Sperry Sun Well Surveying Co | Circulating sleeve |
| US3780578A (en) | 1972-05-02 | 1973-12-25 | Us Navy | Measurement of the total volume flow of a watercourse |
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-
2007
- 2007-12-27 US US11/965,322 patent/US8377079B2/en not_active Expired - Fee Related
-
2008
- 2008-12-19 JP JP2008323435A patent/JP5356006B2/ja not_active Expired - Fee Related
- 2008-12-24 DE DE602008005696T patent/DE602008005696D1/de active Active
- 2008-12-24 AT AT08254158T patent/ATE502608T1/de not_active IP Right Cessation
- 2008-12-24 EP EP08254158A patent/EP2074970B1/en not_active Not-in-force
- 2008-12-29 CN CN2008101847999A patent/CN101467922B/zh not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| ATE502608T1 (de) | 2011-04-15 |
| US20090171378A1 (en) | 2009-07-02 |
| DE602008005696D1 (de) | 2011-05-05 |
| CN101467922A (zh) | 2009-07-01 |
| JP2009187536A (ja) | 2009-08-20 |
| EP2074970B1 (en) | 2011-03-23 |
| EP2074970A1 (en) | 2009-07-01 |
| US8377079B2 (en) | 2013-02-19 |
| JP5356006B2 (ja) | 2013-12-04 |
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