CN101507667B - 带有微机电系统泵的自动调节束带系统 - Google Patents
带有微机电系统泵的自动调节束带系统 Download PDFInfo
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Abstract
本发明涉及用于在患者体内形成限制的装置和方法，更具体地涉及带有微机电系统泵的自动调节束带系统。在一种示例性实施方式中，限制系统包括可植入的限制装置、与所述可植入的限制装置流体连通的可植入的端口，和与所述限制装置流体连通的可植入的泵。总体而言，该可植入的限制装置可调节并且能够在患者体内形成限制，可植入的端口能够从位于患者体外的流体源接收流体。所述可植入泵是能够有效地产生泵送动作以便使流体运动通过泵的微机电系统装置。
Description
技术领域
本发明涉及可植入的医疗装置，更具体地涉及可植入的胃限制装置。
背景技术
特别是在美国，随着肥胖人数持续增加，并且所知道的肥胖对健康的负面影响越来越多，肥胖变得越来越受到关注。人的体重超过理想体重100磅或者更多的病理性肥胖尤其引起严重健康问题的极大风险。因此，大量的注意力被聚焦到治疗肥胖患者上。治疗病理性肥胖的一种方法是围绕胃的上部设置限制装置，诸如细长的束带。胃束带典型地包括具有固定端点的填充了流体的弹性囊，该囊紧邻食道-胃结合部的下部围绕胃，以便在束带上方形成小的胃袋并在胃中形成减小了的人造口。当流体注入囊中时，束带抵靠胃膨胀，从而在胃中形成食物摄取限制部分或者人造口。为了减少这种限制，将流体从束带中去除。束带的作用是减小可利用的胃的容积，并由此在变得“饱胀”之前减少可被消耗掉的食物量。
食物限制装置还包括类似地围绕胃上部的以机械方式调节的胃束带。这些胃束带包括任意数量的弹性材料或者传动装置以及驱动装置，以便调节胃束带。另外，胃束带已经被发展为包括液压和机械驱动元件。这样的可调节胃束带的例子在2000年5月30日公告的题为“Mechanical Food Intake Restriction Device”的美国专利No.6067991中公开，该文献的内容通过引用而包含在本申请中。还已知的是，通过将可膨胀的弹性囊植入到胃腔本身中来限制胃腔中可用的食物容积。囊填充有流体以便抵靠胃壁膨胀，并且由此减少胃内可用的食物容积。
使用上述食物限制装置的每一种进行安全有效的处理都要求所述装置被有规律地监测并调节以改变施加到胃上的限制程度。使用束带装置，在最初植入之后束带上方的胃袋的尺寸显著增加。因此，胃中的人造口最初必须被形成得大到足以使患者能够接收充足养分，同时胃能够适应束带装置。随着胃袋尺寸增加，束带可被调节以改变人造口的尺寸。另外，需要改变人造口的尺寸以便适应患者身体或者治疗状况的变化，或者在更紧急的情况下，减轻梗阻或者严重食管扩张。传统地，调节液压胃束带要求在休伯针和注射器被用于穿刺患者皮肤并经注射端口将流体加入到囊中或者从囊中除去期间按照规定看医生。最近，已经发展了能够以非侵入方式调节束带的可植入泵。外部程序装置使用遥测技术与植入的泵通信，以便对泵进行控制。在按照规定看医生期间，医生将程序装置的手持部分放置在胃植入物附近并将功率信号和命令信号传递给植入物。植入物又调节束带中的流体水平并将响应命令传递给程序装置。
在这些胃束带的调节过程中，难以确定调节进行得怎样，以及调节是否具有所需效果。在用于确定调节效力的尝试中，一些医生采用在正进行调节时吞咽钡的透视法。但是，透视法很昂贵并且由于医生和患者都承受照射量而是不期望的。其他医生指示患者在调节过程中或之后饮用一杯水以确定水是否通过调节的人造口。但是，水法仅仅保证了患者不被阻碍，而不能提供有关调节效力的任何信息。通常，医生基于他们的已有经验可简单地采用“尽可能尝试”法，调节的结果可能直到数小时或者数天后当患者经历了对胃腔的完全阻碍时或者胃束带由于邻靠着胃束带的过大的接触面压力而导致胃组织的侵蚀时才被揭示。
而且，本领域已知的可植入的泵(诸如离心泵或正排量泵)在运转过程中要求较高的功率。这些泵对功率的要求限制了它们在频繁调节束带中的流体水平方面的使用。目前的泵还要求较大的外壳，以便容纳机械泵送机构、齿轮和马达，这进一步限制了它们作为可植入泵的应用。当功率没有被供应到传统的泵时，附加的组成元件(诸如阀)也是必要的，以便保持束带中的流体压力。在2004年5月28日提交的题为“Thermodynamically driven reversible infuserpump for use as a remotely controlled gastric band”、公开号为No.2005/0277974的美国专利申请中公开了可植入泵系统的一个例子。
发明内容
因此，本发明提供了用于胃限制装置的装置和方法，更具体地提供了允许调节胃限制装置的装置和方法。
本发明总体提供了用于在患者体内形成限制的系统和方法。在一种示例性实施方式中，限制系统包括可植入的限制装置和与该限制装置流体连通的可植入的微机电系统(MEMS)泵。任选地，可植入端口与可植入的限制装置和泵流体连通。可植入的限制装置是可调节的并且能够在患者体内形成限制，如果存在可植入端口，该可植入端口能够从位于患者体外的流体源接收流体。可植入的MEMS泵具有设置在泵外壳内的流体室。泵室具有设置于流体室和入口室之间的入口阀，以及设置于流体室和出口室之间的出口阀。所述泵还包括与流体室流体连通的泵送隔膜，以及邻近泵送隔膜的电极。该泵送隔膜能够响应于施加到电极上的电压而偏转(deflect)。泵送隔膜的偏转在流体室以及入口室和出口室之间产生压差，从而控制通过泵的流体流。入口阀和出口阀能够响应于流体室中的压力变化而打开和关闭。限制系统中的流体可沿着从MEMS泵到限制装置的方向运动或者沿着从限制装置到MEMS泵的方向运动。在一种实施方式中，泵与可植入端口流体连通。所述系统还可包括可植入的传感器，该传感器与限制装置相通信并且至少能够测量在限制装置内的压力。限制系统可任选地包括与泵流体连通的流体容器。该流体容器能够保持流体并且能够保持大约0.1ml至20ml范围内的流体。
泵可被手动地启动，以便使流体向着限制装置运动或者使流体运动离开限制装置。替代地，泵可例如通过包括时钟控制的技术被自动地启动，或被编程而响应于某些感测的参数而启动。在一种实施方式中，可植入泵根据所检测的事件和程序表中的至少一种使限制装置内的压力变化。
本文还公开了用于调节可植入的限制装置中的压力的方法。在一种实施方式中，该方法包括：感测临床相关参数，响应于所感测的临床相关参数通过启动与限制装置流体连通的泵而调节该限制装置内的压力。在一种实施方式中，泵可以是能够有效地产生泵送动作以便使流体运动通过泵的微机电系统(MEMS)装置。临床相关参数的感测可通过使用可植入的传感器实现。临床相关参数可以是压力，在这种情况下，可植入的传感器是压力传感器。在这种实施方式中，所感测的压力与期望压力范围比较，并且如果所感测的压力未处于期望压力范围内，则限制装置内的压力被调节成大致处于该期望压力范围内。在一种实施方式中，泵可自动地被启动，但是也可想到包括手动启动的其他启动技术。
在另一种实施方式中，提供了一种可植入的微机电系统(MEMS)泵，该MEMS泵与流体源和流体目标流体连通，并且能够选择性地在流体源和流体目标之间传递流体。流体源和流体目标可被植入体内和/或是体内天然存在的部位。所述流体可以是任何流体，包括是或含有一种或多种治疗有效剂和/或生物学有效剂的流体。
更具体地说，本发明涉及如下内容：
(1)、一种用于在患者体内形成限制的限制系统，包括：
可植入的限制装置，其可调节并且能够在患者体内形成限制；和
可植入的微机电系统泵，其与所述限制装置流体连通。
(2)、如第(1)项所述的系统，还包括能够从位于患者体外的流体源接收流体的可植入的端口，该可植入的端口与所述可植入的限制装置和所述泵流体连通。
(3)、如第(1)项所述的系统，还包括与所述限制装置相通信的可植入的传感器。
(4)、如第(3)项所述的系统，其中，所述可植入的传感器至少能够测量在所述限制装置内的压力。
(5)、如第(1)项所述的系统，其中，所述微机电系统泵包括：
泵外壳；
流体室，其设置在所述泵外壳内并且具有设置于所述流体室和入口室之间的入口阀，以及设置于所述流体室和出口室之间的出口阀；
泵送隔膜，其与所述流体室流体连通；和
电极，其邻近所述泵送隔膜，
其中，所述泵送隔膜能够响应于施加到所述电极上的电压而偏转，从而在所述流体室和所述入口室之间以及在所述流体室和所述出口室之间产生压差以便控制通过泵的流体流。
(6)、如第(5)项所述的系统，其中，所述入口阀和出口阀能够响应于所述流体室中的压力变化而打开和关闭。
(7)、如第(5)项所述的系统，其中，流体能够沿着从所述微机电系统泵到所述限制装置的方向运动。
(8)、如第(5)项所述的系统，其中，流体能够沿着从所述限制装置到所述微机电系统泵的方向运动。
(9)、如第(1)项所述的系统，其中，所述可植入的微机电系统泵根据所检测的事件和程序表中的至少一种使所述限制装置内的压力变化。
(10)、如第(1)项所述的系统，还包括与所述微机电系统泵流体连通的流体容器。
(11)、如第(10)项所述的系统，其中，所述流体容器能够保持大约0.1ml至20ml范围内的流体。
(12)、如第(1)项所述的系统，其中，所述微机电系统泵用作能够通过允许、阻止或限制流体通过而选择性地控制流体通过的阀。
(13)、一种用于调节可植入的限制装置中的压力的方法，该方法包括：
感测临床相关参数；
响应于所感测的临床相关参数通过启动与所述限制装置流体连通的泵而调节该限制装置内的压力，其中所述泵是能够有效地产生泵送动作以便使流体运动通过泵的微机电系统装置。
(14)、如第(13)项所述的方法，其中，感测临床相关参数通过使用可植入的传感器实现。
(15)、如第(13)项所述的方法，其中，所述临床相关参数是所述可植入的限制装置中的压力。
(16)、如第(13)项所述的方法，其中，所述泵是自动启动的。
(17)、如第(13)项所述的方法，其中，调节压力向患者提供反馈。
(18)、如第(15)项所述的方法，还包括：将所感测的压力与期望压力范围比较，并且如果所感测的压力未处于所述期望压力范围内，则将所述限制装置内的压力调节成处于所述期望压力范围内。
(19)、一种可植入的医疗装置，包括：
与流体源和流体目标流体连通的可植入的微机电系统泵，该微机电系统泵能够选择性地在所述流体源和流体目标之间传送流体。
附图说明
通过以下结合附图的详细描述，本发明将会被更全面的理解，其中：
图1A是食物摄入限制系统的一种实施方式的示意图；
图1B是图1A的食物摄入限制系统的可植入部分的一种实施方式的立体图；
图2A是图1A的食物摄入限制装置的立体图；
图2B是围绕患者的胃食管结合部应用的图2A的食物摄入限制装置的示意图；
图3是图1A的注射端口外壳的一种实施方式的立体图；
图4是图1A的传感器外壳的一种实施方式的立体图；
图5是根据本发明一种实施方式的食物摄入限制系统的可植入部分的立体图；
图6是可植入的MEMS泵的示例性实施方式的剖视图；
图7A是处于静止状态的图6的泵的剖视图；
图7B是图6的泵的剖视图，示出了在电流施加到电极上时隔膜的偏转；
图7C是图6的泵的剖视图，其中入口阀响应于流体室中的压力变化而打开；
图7D是图6的泵的剖视图，其中出口阀响应于流体室中的压力变化而打开；
图8是图6的泵的示意图，示出了流体通过泵的路径。
具体实施方式
现在将描述一些示例性实施方式以提供对本文中公开的装置和方法的结构、功能、制造以及用途的原理的全面理解。这些实施方式的一个或多个例子在附图中示出。本领域技术人员将会理解，在本文中具体描述并在附图中示出的装置和方法都是非限制性的示例性实施方式，本发明的范围仅仅由权利要求书来限定。结合一种示例性实施方式示出或描述的特征可与其他实施方式的特征组合。这种修改和变化也都包含在本发明的范围内。
本发明总体上提供了用于在患者体内形成限制的系统和方法。总体而言，该系统和方法允许调节限制装置中的流体压力或流体体积。压力或体积调节通过使用可植入泵实现。可植入泵允许调节限制装置中的流体压力或流体体积，而无需从外部源加入流体。
虽然本发明可被用于本领域已知的各种限制系统，但是图1A示出了在患者体内使用的食物摄入限制系统10的一种示例性实施方式。如图所示，系统10一般包括可植入部分10a和外部部分10b。图1B示出了位于患者体外的可植入部分10a。可植入部分10a包括被构造成围绕患者的胃40的上部定位的可调节胃束带20和例如经过导管50与可调节胃束带20流体连接的注射端口外壳30。
注射端口外壳30适于允许流体被引入到胃束带20中以及从胃束带20中除去，从而调节束带的尺寸并由此调节施加到胃上的压力。注射端口外壳30可被植入到体内可通过组织接触的位置中。典型地，注射端口被定位在患者腹部的皮肤和脂肪组织层下的横向肋下的区域中。医生还典型地将注射端口植入到患者胸骨上。
内部部分10a还可包括与可植入部分10a中的封闭流体回路流体连通的感测或测量装置，测量装置可以获取与可植入限制装置相关的任何参数的测量结果。这些临床相关参数包括但不限于温度、压力、压力变化、声学输入、组织阻抗、所感测的组织阻抗中的变化、化学成分、化学成分中的变化、脉冲计数、脉冲宽度和幅值。尽管此处讨论的装置和方法可以涉及任何感测的数据参数，但是在一种示例性实施方式中，测量结果涉及压力，并且此处讨论的装置和方法将就测量封闭流体回路的流体压力来讨论。尽管测量装置可具有各种构造并可被定位在沿着内部部分10a的任何位置，包括定位在注射端口外壳30中，但是在图示的实施方式中，测量装置为压力传感器的形式，该压力传感器被设置在与注射端口外壳30相邻定位的传感器外壳60中。导管50可包括连接在胃束带20和传感器外壳60之间的第一部分和连接在传感器外壳60与注射端口外壳30之间的第二部分。
除了感测内部部分10a内的流体压力之外，食管和/或胃40中的流体压力还可使用任何合适的装置感测，诸如使用内窥镜压力计感测。作为非限制性的例子，这种流体压力测量可与在内部部分10a内的压力调节之前、过程中和/或之后该内部部分10a中所测量的流体压力进行比较。本领域技术人员可理解用于食管和/或胃40中的所测量压力的其他合适用途。
如同在图1A中进一步显示的那样，外部部分10b一般包括数据读取装置70，该数据读取装置70被构造成定位在传感器外壳60(其可植入厚的组织下面，例如超过10cm厚)上方的皮肤表面上，以便以非侵入方式与传感器外壳60通信并由此获得压力测量结果。数据读取装置70可任选地与控制箱90(在该实施方式中经过电缆组件80)电联接，该控制箱90可显示压力测量结果，和/或得自压力读取装置70的其他数据。
图1B更详细地示出了可植入部分10a。在示出的实施方式中，可植入部分10a包括：可调节胃束带20；与可调节胃束带20流体连接的注射端口外壳30；传感器外壳60；和泵110。泵110可以具有各种构造，这将在下面更详细地讨论。在图1B示出的实施方式中，泵110通常容纳在泵外壳112中。
图2A更详细地显示了胃束带20。虽然胃束带20可具有各种构造，并且本领域目前已知的各种胃束带都可被用于本发明，但是在示出的实施方式中，胃束带20具有大致细长的形状，并带有具有相对的第一端部20a和第二端部20b的支撑结构22，第一端部20a和第二端部20b可彼此固定。各种配合技术可被用于将端部20a、20b彼此固定。在示出的实施方式中，端部20a、20b为配合在一起的条带的形式，并且一个叠置于另一个顶部上。胃束带20还可包括可变容积构件，诸如可膨胀囊24，该可变容积构件设置在支撑结构22的一侧上或在支撑结构22的一侧上形成，并被构造成与组织邻近定位。囊24可抵靠着胃的外壁膨胀或者收缩，以便形成可调节的人造口，从而可控制地限制食物摄入到胃中。
本领域技术人员将会理解，胃束带可具有各种其他构造，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可植入束带。例如，束带可被用于治疗大便失禁，如同在美国专利No.6461292中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗小便失禁，如同在美国专利申请No.2003/0105385中描述的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗胃灼热和/或返酸，如同在美国专利No.6470892中公开的那样，该文献的内容通过引用而包含在本申请中。束带还可被用于治疗阳痿，如同在美国专利申请No.2003/0114729中描述的那样，该文献的内容通过引用而包含在本申请中。
图2B显示了围绕患者的胃食管结合部应用的可调节胃束带20。如图所示，束带20至少大体上围绕胃40的靠近与食管42的结合部的上部。优选以束带20中含有少量或者不含流体的紧缩构型将束带20植入后，束带20可例如使用生理盐水被膨胀，以缩小人造口开口的尺寸。本领域技术人员将会理解，各种技术(包括机械技术和电技术)都可被用于束带。图2B还示出了压力传感器41的替代位置，该压力传感器41设置在束带20的带扣43中。
流体注射端口外壳30也可具有各种构造。在图3中显示的实施方式中，注射端口外壳30具有大致圆柱形形状，该圆柱形形状具有远侧面或底面以及从底面向近侧延伸并限定了近侧开口32的周壁。近侧开口32可包括延伸穿过该开口并提供了在外壳中形成的流体容器(在图3中不可见)的入口的针穿刺膜34。膜34优选设置在足够靠近的位置，使容器的深度足以暴露于针(诸如休伯针)的开口尖端，使流体输送可发生。膜34优选被设置成使其在被针穿刺并且针退出后自密封。如图3中进一步显示的那样，注射端口外壳30可还包括导管连接件36，该导管连接件36与容器流体连通并被构造成与导管(例如导管50)联接。本领域技术人员将会理解，外壳可由任意数目的材料制成，包括不锈钢、钛或者聚合物材料，并且膜34同样可由任意数目的材料制成，包括硅树脂。
如上所述，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压力(例如流体压力)的压力测量装置。测量压力使人们(例如医生、护士、患者等)能够评估由束带调节形成的限制的效力和功能。如图4中所示，在示出的实施方式中，压力测量装置为设置在传感器外壳60中的压力传感器62的形式。但是，压力测量装置可设置在可植入部分的封闭液压回路中的任何位置，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 PressureMeasurement In A Fluid Adjustable Restrictive Device”，该文献通过引用而包含在本申请中。
一般说来，图示的传感器外壳60包括与可植入部分10a中的流体流体连通的入口60a和出口60b。已经植入的导管50可被改进用于传感器外壳60，诸如通过切割导管50并将带倒刺的连接器(或者任何其他连接器，诸如夹钳、夹片、粘合剂、焊接等)插入到导管50的被切割的端部。传感器62可设置在外壳60中并被构造成响应于液压回路中的流体压力变化并将压力变化转化成数据的可使用形式。设置在外壳60中的压力传感器62可以感测和监测静态或在流体正被泵送时束带的调节状态。
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。
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)和Remon Medical公司。一种示例性的MEMS压力传感器在美国专利No.6855115中描述，该文献的内容通过引用而包含在本申请中，仅用于说明的目的。本领域技术人员还能理解，合适的压力传感器可包括但不限于电容传感器、压阻传感器、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或者传感器外壳60被植入到厚(至少超过10cm)的皮下脂肪组织之下时也是如此。医生可依靠传感器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。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示出了可植入限制系统10的可植入部分10a(图1A和图1B)的近端的一种实施方式。如图所示，可植入部分10a的近端包括注射端口外壳30，该注射端口外壳30与容器105和泵110流体连通。所述近端还可包括传感器外壳60以及一根或多根传感器/功率导线101。管道50a在可植入部分10a的近端的不同组成元件之间提供流体连通。导管50在如图5所示的可植入部分10a的近端和位于下游的限制装置20(图1B)之间提供流体连通。尽管图5所示的组成元件被显示为串联构型，但是本领域技术人员可以理解，这些组成元件可以任何顺序和任何构型(即，例如以T构型或Y构型)连接。
如图5所示，如果存在注射端口外壳30的话，该注射端口外壳30可以任选包括锚固装置(诸如钩35)，用于将注射端口外壳30锚固到患者体内。尽管在图5中示出的外壳30与容器105、泵110和传感器外壳60串联，但是外壳30可以其他方式连接到其他组成元件和管道50a，即，例如以T构型或Y构型连接。注射端口外壳30本身是可选的，因为可植入部分10a(图1B)在植入前或在植入时可被充满流体。之后，在下游的限制装置20(图1B)中的压力可通过采用泵110使流体运动进入限制装置20或离开限制装置20而调节。
容器105提供了用于保持流体的附加供应的可选部件。例如，容器105可容纳0.1ml至20ml的流体。如图所示，容器105可以是管道50a的一部分，并且该部分的直径比管道50a的标称直径大。可以使用各种其他构造提供容器105，诸如与管道50a或任何其他组成元件(即，注射端口外壳30、泵110或传感器外壳60)连接和流体连通的单独的容器组成元件。尽管图5示出的容器105被设置成串联在泵110和传感器外壳60之间，但是本领域技术人员可以理解，容器105可以其他方式连接到其他组成元件和管道50a，即，例如以T构型或Y构型连接。还可以理解的是，容器105不必容纳足以充满和排空整个束带20的流体(图1A和图1B)。例如，在首次填充束带20的过程中，流体可通过注射端口外壳30注射而传输。在该时刻，泵110可以保持在打开位置。替代的，容器105可被充满并且之后流体通过泵110被传输到束带20。当束带20处于总体功能(functional fullness)时，即堵塞胃足以导致摄入限制时，容器105可被填充足以满足将来填充和调节要求的流体，而无须通过注射端口外壳30加入附加流体。本领域技术人员可以理解，容器105是任选的，在一种实施方式中没有容器105，管道50a可任选地包含足以允许调节束带20中的流体量的流体(未示出)。
图5中显示的实施方式包括任选的传感器外壳60，该传感器外壳60被设置成与可植入部分10a(图1B)的近端的组成元件流体连通。尽管图5示出的传感器外壳60被设置成串联在导管50和管道50a之间，但是本领域技术人员可以理解，传感器外壳60可以其他方式连接到其他组成元件，即，例如以T构型或Y构型连接。替代地，传感器可设置在系统中的其他位置，诸如束带本身上。传感器/功率导线101可提供传感器外壳60和泵110之间的连接，以便向泵供应能量，如下面将要更详细地说明的。
可植入泵110用于使流体运动进入束带20和从束带20离开，以便根据需要增大或减小束带内的压力。尽管泵可具有各种构造，但是在一个例子中，泵基于微机电系统(MEMS)技术，如下面将要更详细地说明的。总体而言，MEMS技术的特征在于使用亚毫米级的元件。使用MEMS技术形成可植入泵110提供了很多优点，诸如尺寸小、低电压要求并且在运动部件的数目方面而言简单。附加的优点包括制造成本降低、性能得到改进、高准确度、高精确度、快速响应时间，以及在较大尺寸等级无法获得的结构。
图6示出了MEMS泵的一种示例性实施方式。如图所示，泵110通常被容纳在泵外壳112内，该泵外壳112具有近端114和远端116，近端114包括内腔118a，远端116包括内腔118b。内腔118a、118b被设置成与可植入部分10a(图1B)的近端的组成元件流体连通。泵外壳112可任选地与管道50a一体地形成(图5)，使得泵110与导管50和下游的限制装置20流体连通。如图所示，泵110包括电极126，该电极126邻近被设置成与流体室124流体连通的泵送隔膜120设置。泵110可包括入口室130和出口室133。入口室130被设置成通过入口孔131与流体室124流体连通。类似地，出口室133被设置成通过出口孔134与流体室124流体连通。泵还可包括入口阀132和出口阀135。在使用中，如下面将更详细说明的，隔膜120被构造成响应于施加到电极126上的电压而偏转，由此在流体室124以及入口室130和/或出口室之间产生压差。泵外壳112可具有各种构造，但是在一种示例性实施方式中，该泵外壳112与管道50a串联地形成。根据所需用途，泵外壳112的形状和尺寸、以及用于形成外壳112及其内部组成元件的材料可以变化。MEMS装置通常由硅酮制成，但是也可由聚合物、金属或形状记忆合金制成。在一些示例性实施方式中，泵外壳112可由生物相容性聚合物(诸如硅酮或胶乳)形成。其他合适的生物相容性弹性体和聚合物包括但不限于合成聚异戊二烯、氯丁二烯、含氟弹性体、腈、氟硅酮、聚偏二氟乙烯(PVDF)和液晶聚合物(LCP)。
本领域技术人员将会理解，可对材料进行选择，以便获得所需的机械性能。尽管未示出，外壳112还可包括其它特征元件，以便于将外壳112连接到医疗装置、流体源等。
本领域技术人员将会理解，微流体泵装置可由两层弹性体材料形成。一层包含用于液体流动的通道(即，流动层)，另一层(即控制层)包含能够在受到空气/流体加压时将隔膜阀偏转入流动通道并阻挡液体流的通道。本领域技术人员还可理解，所述阀可以被结合入MEMS芯片中。
泵110可具有各种构造。在示出的实施方式中，泵外壳112包括一系列流体室。主流体室124形成于泵外壳112内并与泵送隔膜120流体连通。而且，主流体室124被设置成通过入口孔131和出口孔134分别与入口室130和出口室133流体连通。入口室130和出口室133分别通过入口阀132和出口阀135与主流体室124隔开。所述阀可具有各种构造。在示出的实施方式中，入口阀132和出口阀135被形成为板簧，这些板簧被偏压成处于关闭位置，即，被偏压成处于防止流体流过孔131和134的位置。入口阀132可以被设置在主流体室124内并且允许流体从入口室130经过进入主流体室124。出口阀135可以被设置在出口室133内并且允许流体从主流体室124进入出口室133。本领域技术人员将会理解，入口阀132和出口阀135的位置可以互换。本领域技术人员还可理解，入口室130和出口室133中的一个或两个是可选的。例如，内腔118a、118b的一个或两个可直接连接到主流体室124。在这样一种构造中，入口阀132和/或出口阀135可例如形成于内腔118a、118b中。如上所述，泵110的元件(包括阀132、135)可以亚毫米级形成。
泵送隔膜120也可被构造成各种构造。在示出的实施方式中，泵送隔膜120设置在外壳112内并设置成与主流体室124流体连通。泵送隔膜120可由能够响应于施加到电极126上的电压所产生的电场的合适的生物相容性聚合物或金属形成。电极126也可具有各种构造。在示出的实施方式中，电极126形成于泵外壳112内并且邻近泵送隔膜120设置。本领域技术人员可理解，电极126可以设置在任何位置。例如，电极126可设置在泵送隔膜120的下表面上。本领域技术人员还可理解，电极126可由耐蚀材料(诸如铂或其他贵金属，以便能承受腐蚀性流体(harsh fluid)，诸如生理盐水)制成。
使用MEMS技术形成泵的其中一个优点是能够获得小的整体尺寸和小体积的调节。仅仅举例来说，整个泵的最大尺寸可以小于大约5mm(包括控制电子器件)。尽管泵可被设计成获得任何期望流速，但是流速可低至0.1ml/min到0.5ml/min。实现期望压力调节所需的总体积变化可通过以这种流速操作泵来传递。例如，传递到束带20的总体积对于给定的期望调节可以小于1ml。
如图所示，电极126邻近泵送隔膜120设置。泵送隔膜120的位置可通过施加到电极126上的电压来控制。本领域技术人员可理解，如下所述，取决于多种因素，所施加的电压可以是变化的，并且通常在大约2伏至大约200伏的范围内。施加到电极的电压取决于多种因素，例如MEMS装置的切换速度、所需的切换力或偏转力以及可靠性。例如，大约25微秒的较高切换速度需要大约10-15伏的电压，而较低的切换速度通常需要小于大约5伏的电压。在替代的例子中，可使用高压静电致动器，对于这些致动器，电压可以是在大约10伏至300伏的范围内。电极126可被连接到电池或其他能量源。尽管泵110适于植入患者体内，但是电极126可连接到变换器，该变换器能够植入皮下并且能够存储能量和/或从位于患者体外的外部源接收能量。例如，变换器或功率源可被包含在传感器外壳60中并且传感器/功率导线(未显示)可将能量输送给电极126。替代地，能量可通过外部装置(例如图1A所示读取装置70)供应，例如在外部装置被运动到传感器外壳60附近时，该外部装置能够将能量经皮传输给传感器外壳60(图5)。外部装置可以是运动的(例如可以被摇动或放置在传感器外壳60附近的棒或手持式单元)或者是固定的(例如患者可运动到附近的床侧箱、台式安装箱或者车载安装箱)。
图7A-7D示出了一种用于在泵110内产生压差以便使流体运动通过泵110的示例性方法。在一种示例性实施方式中，泵使流体沿着远侧方向朝着束带运动(图1B)，束带位于泵110的远侧。图7A示出的泵110处于静止状态，并且泵送隔膜120基本上未偏转，入口阀132和出口阀135二者关闭。当电压被施加到电极126时，泵送隔膜120偏转并且被朝着电极126拉动至材料特性允许被拉动的程度，如图7B所示。替代地，硬止挡件(hard stop)可以限制隔膜120的行程，对其运动进行精确地控制。本领域技术人员可理解，当电极126被设置在其他位置时，如上所述，泵送隔膜可替代地与电极相排斥。
主流体室124的容积的增大可导致相对于入口室130和出口室133中的压力的压力降低。如图7C所示，入口室130和主流体室124之间的压差导致入口阀132打开，从而允许流体进入主流体室124，直到压力相等。在该时刻，主流体室124和出口室133之间的压差迫使出口阀135保持关闭。当来自入口室130的流体已经充满主流体室124时，施加到电极126上的电压减小，从而允许泵送隔膜120恢复到其静止状态。由于泵送隔膜120运动回其静止状态而导致的主流体室124的容积的减小导致主流体室124中相对于入口室130和出口室133中的压力的压力升高。如图7D所示，主流体室124和出口室133之间的压差导致出口阀135打开，从而允许流体运动进入出口室133，直到压力相等。在该时刻，主流体室124和入口室130之间的压差迫使入口阀132保持关闭。在需要时图7A-7D示出的过程可以被重复，以继续泵送动作。
图8示出了流体通过泵110的路径150。在示出的实施方式中，泵使流体沿着远侧方向朝着束带(图1B)运动，束带位于泵110的远侧。流体从泵110的近端114处的内腔118a运动进入入口室130、穿过入口阀132进入主流体室124。然后流体经过出口阀135进入出口室133并通过泵110的远端116的内腔118b。本领域技术人员可理解，在需要时流体室和阀的设置可以被改变，以便允许流体沿着近侧方向运动离开束带(图1B)。例如，由于束带是系统的高压侧，回流阀可简单地打开以允许从束带排出流体。替代地，第二个MEMS泵可与第一个MEMS泵以相反的方向定向，以便将流体泵送离开束带。
本发明还提供了一种用于调节可植入的限制系统10中的压力的方法。在一种实施方式中，所述方法包括：感测临床相关参数，响应于所感测的临床相关参数通过启动与限制装置20流体连通的泵而调节该限制装置内的压力。所述泵可以是参照图6-8说明的基于MEMS的泵。也就是说，所述泵可以是能够有效地产生泵送动作以便使流体运动通过泵的微机电系统装置。所述临床相关参数可使用可植入传感器感测。
在一种实施方式中，所感测的临床相关参数是压力，但是可以理解，所述临床相关参数可包括以上指出的其他参数的任何一种，以及其他临床相关参数。在一种实施方式中，压力可使用可植入压力传感器62感测，如上所述。所述方法可包括：感测植入的限制装置20中的压力；将所感测的压力与期望压力(包括期望压力范围)进行比较；以及如果所感测的压力不等于期望压力(或期望压力范围)，通过启动与限制装置20流体连通的泵来获得限制装置中的期望压力(或期望压力范围)，从而将限制装置20中的压力调节成大致等于期望压力(或期望压力范围)。
在一种实施方式中，如果所感测的束带20中的临床相关参数(例如压力等)高于期望值或范围，泵110自动启动，在这种情形中，从束带20中泵送出流体以减小压力。相反地，如果所感测的束带20中的参数低于期望值或范围，流体可被(例如从容器或植入的导管)泵送入束带，直到达到该参数的期望目标。在另一种构造中，如果测量与不期望的饮食习惯相关的感测的束带20中的临床相关参数(例如压力梯度、在给定持续时间内的绝对压力等)，流体可被(例如从容器或植入的导管)泵送到束带中，直到产生足够的限制。该限制可通过引起生理反应(例如呕吐等)而(立即或延迟地)为患者提供反馈而停止进食。该限制可被适当地保持，直到启动事件(例如经过的时间)发生，以使系统返回正常工作状态。为了安全目的，可提供由患者或其他护理者启动的超驰控制(override)。该超驰控制可通过食物摄入限制系统10的外部部分10b的功能启动。可使用诸如时钟控制的用于自动致动的其他技术，或系统可被编程而响应于某些感测的参数或事件或根据程序表而启动泵。例如，可植入泵可在确定患者正在进食或者处于清醒状态时(例如在一天的选定时间内)使限制装置内的压力增加(也就是使流体朝着限制装置运动)，并且该可植入泵可在患者处于睡眠状态时(或者在一天的其他选定时间)使限制装置中的压力减小(也就是使流体运动离开限制装置)。本领域技术人员可以理解，程序表可根据多种因素，包括日子类型(例如假日、工作日、周末)、预期的患者活动等等。本领域技术人员可以理解，束带20中的压力可使用闭环方法(诸如PID(比例-积分-微分)控制模式)或其他合适的方法(包括数字控制模式)进行控制。
本领域技术人员将会理解，某些安全特征元件可被结合在泵设计中，以便一旦出现故障或功率损耗时提供应急措施。仅仅举例来说，如果检测到停电(或故障)，或者如果剩余功率下降到预定阈值以下，系统可被构造成默认地置于松弛状态，在该松弛状态，限制被放松和/或打开，直到功率水平恢复或故障被消除。
在本文中公开的装置可被设置成在单次使用后被处理，或者它们可被设计成多次使用。但是，在任一情况下，装置在至少一次使用后可被再生以便重新使用。再生可包括装置的拆卸、接着清洁或替换特定部件以及随后重新组装的步骤的任一组合。特别是，装置可被拆卸，并且装置的任意数目的特定部件或部分可选择性地以任何组合被替换或者除去。当清洗和/或替换特定部分时，装置可在再生工厂或者由手术团队在外科手术前立即被重新组装以便随后的使用。本领域技术人员将会理解，装置的再生可利用用于拆卸、清洗/替换以及重新组装的各种技术。所述技术的使用以及获取的再生装置都落入本发明的范围内。
优选地，在本文中公开的本发明将在外科手术前被处理。首先，获取新的或者使用过的器械并在需要的情况下对其进行清洁，该器械然后可被灭菌。在一种灭菌技术中，容器和器械被放置在闭合并密封的容器中，诸如塑料袋或高密度聚乙烯合成纸袋中。容器和器械然后被放置在可穿透容器的辐射场中，诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌的器械然后可被储存在灭菌容器中。密封的容器保持器械处于灭菌状态，直到其在医学场合下被打开。
优选的装置被灭菌。这可通过本领域已知的任何数目的方式来实现，包括β或γ射线、环氧乙烷、蒸汽。
在上述实施方式的基础上本领域技术人员将会理解本发明的进一步的特征和优选。因此，除非由权利要求书特别指明，本发明不由特别显示和描述的那些内容来限定。在本文中引证的所有出版物和参考文献通过全文引用而明确包含在本申请中。
Claims (10)
1.一种用于在患者体内形成限制的限制系统，包括：
可植入的限制装置，其可调节并且能够在患者体内形成限制；和
可植入的微机电系统泵，其与所述限制装置流体连通，
如果检测到停电或故障，或者如果剩余功率下降到预定阈值以下，所述限制系统被构造成默认地置于松弛状态，在该松弛状态，限制被放松和/或打开，直到功率水平恢复或故障被消除。
2.如权利要求1所述的限制系统，还包括能够从位于患者体外的流体源接收流体的可植入的端口，该可植入的端口与所述可植入的限制装置和所述泵流体连通。
3.如权利要求1所述的限制系统，还包括与所述限制装置相通信的可植入的传感器。
4.如权利要求3所述的限制系统，其中，所述可植入的传感器至少能够测量在所述限制装置内的压力。
5.如权利要求1所述的限制系统，其中，所述微机电系统泵包括：
泵外壳；
流体室，其设置在所述泵外壳内；
入口室；
出口室；
入口阀，其设置于所述流体室和入口室之间；
出口阀，其设置于所述流体室和出口室之间；
泵送隔膜，其与所述流体室流体连通；和
电极，其邻近所述泵送隔膜，
其中，所述泵送隔膜能够响应于施加到所述电极上的电压而偏转，从而在所述流体室和所述入口室之间以及在所述流体室和所述出口室之间产生压差以便控制通过微机电系统泵的流体流。
6.如权利要求5所述的限制系统，其中，所述入口阀和出口阀能够响应于所述流体室中的压力变化而打开和关闭。
7.如权利要求5所述的限制系统，其中，流体能够沿着从所述微机电系统泵到所述限制装置的方向运动。
8.如权利要求5所述的限制系统，其中，流体能够沿着从所述限制装置到所述微机电系统泵的方向运动。
9.如权利要求1所述的限制系统，其中，所述可植入的微机电系统泵根据所检测的事件和程序表中的至少一种使所述限制装置内的压力变化。
10.如权利要求1所述的限制系统，还包括与所述微机电系统泵流体连通的流体容器。
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| US12/029,794 | 2008-02-12 | ||
| US12/029,794 US8057492B2 (en) | 2008-02-12 | 2008-02-12 | Automatically adjusting band system with MEMS pump |
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| CN101507667B true CN101507667B (zh) | 2012-11-28 |
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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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- 2009-02-11 RU RU2009104686/14A patent/RU2506060C2/ru not_active IP Right Cessation
- 2009-02-11 BR BRPI0901283A patent/BRPI0901283B8/pt not_active IP Right Cessation
- 2009-02-11 EP EP09250334.1A patent/EP2090271B1/en not_active Not-in-force
- 2009-02-12 CN CN2009100057973A patent/CN101507667B/zh not_active Expired - Fee Related
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Also Published As
| Publication number | Publication date |
|---|---|
| BRPI0901283B1 (pt) | 2019-07-09 |
| EP2090271A3 (en) | 2013-02-27 |
| BRPI0901283B8 (pt) | 2021-06-22 |
| US8057492B2 (en) | 2011-11-15 |
| BRPI0901283A2 (pt) | 2010-04-06 |
| JP2009189810A (ja) | 2009-08-27 |
| RU2506060C2 (ru) | 2014-02-10 |
| EP2090271A2 (en) | 2009-08-19 |
| HK1135592A1 (zh) | 2010-06-11 |
| JP5496519B2 (ja) | 2014-05-21 |
| CN101507667A (zh) | 2009-08-19 |
| US20090204131A1 (en) | 2009-08-13 |
| RU2009104686A (ru) | 2010-08-20 |
| EP2090271B1 (en) | 2016-06-08 |
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