CN101507668A - 自动调节的束带系统 - Google Patents
自动调节的束带系统 Download PDFInfo
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- A—HUMAN NECESSITIES
- 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
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/12—Machines, pumps, or pumping installations having flexible working members having peristaltic action
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Abstract
本发明公开了用于在患者体内形成限制的装置和方法,具体地涉及自动调节的束带系统。在一种示例性实施方式中,限制系统包括可植入限制装置、与所述可植入限制装置流体连通的可植入端口以及与所述限制装置流体连通的可植入泵。通常,可植入限制装置能被调节并且被构造成在患者体内形成限制,可植入端口被构造成接收来自患者体外的流体源的流体。可植入泵具有多个致动器,所述多个致动器被构造成在将能量施加到所述多个致动器上时改变形状,使得所述多个致动器的顺序激励有效地产生泵送作用以使流体通过所述泵。
Description
技术领域
本发明涉及可植入的医疗装置,尤其是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有流体的弹性囊,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定期看医生,在看医生期间用休伯针和注射器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。最近,已经开发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。在定期看医生期间,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送给植入物。植入物又调节束带中的流体水平并将响应命令传送给程序装置。
在这些胃束带的调节过程中,难以确定调节进行得如何,以及调节是否具有预期效果。在确定调节效力的尝试中,一些医生采用在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。
另外,本领域已知的可植入泵(诸如离心泵或正排量泵)在工作中具有高功率要求。泵的这种功率要求限制了它们在频繁调节束带中的流体水平方面的用途。目前的泵还需要较大外壳以装纳机械式泵送机构、齿轮和马达,这进一步限制了它们作为可植入泵的实用性。当动力未被施加到传统的泵时,还需要其它部件(诸如阀)来保持束带中的流体压力。可植入泵系统的例子在2004年5月28日提交的、题为“Thermodynamically driven reversible infuser pump foruse as a remotely controlled gastric band”的美国专利公布No.2005/0277974中公开。
发明内容
因此,本发明提供了与胃限制装置一起使用的方法和装置,并且具体地提供了允许调节胃限制装置的方法和装置。
本发明总的提供了用于在患者体内形成限制的系统和方法。在一种示例性的实施方式中,限制系统包括可植入限制装置和与限制装置流体连通的可植入泵。任选地,可植入端口可与可植入限制装置和可植入泵流体连通。可植入限制装置是可调节的并且被构造成用于在患者体内形成限制,可植入端口(如果存在)被构造成接收来自患者体外的流体源的流体。可植入泵具有多个致动器,在将能量施加在致动器上时,所述致动器的形状发生变化,使得多个致动器的顺序激励有效地产生泵送作用以使流体通过泵。限制系统中的流体可沿着从泵至限制装置的方向或者沿着从限制装置至泵的方向运动。在一种实施方式中,泵可与可植入端口流体连通。系统还可包括可植入传感器,该可植入传感器与限制装置通信并且被构造成至少测量限制装置内的压力。任选地,限制系统可包括与泵流体连通的流体容器。流体容器被构造成保持流体并且可被构造成保持范围在大约0.1ml至20ml的流体。
可植入泵及其多个致动器可被设置成各种构造。在一种示例性的实施方式中,泵包括具有通道并且与多个致动器通信的第一构件,该通道贯穿第一构件形成。致动器可被设置在第一构件内或者第一构件外。至少一个致动器被构造成在将能量施加于其上时(例如径向地或轴向地)扩张或收缩,并且每个致动器可被构造成顺序运动或独立地运动。在一种实施方式中,所述致动器的至少一个可用作阀,该阀能够通过允许、阻止或限制流体通过来选择性地控制流体的通过。在一种示例性的实施方式中,每个致动器包括电活性聚合物。
泵可被手动地启动以使流体朝着限制装置运动或离开限制装置。替代地,泵可诸如通过包括时钟控制的技术自动地启动,或者被编程为响应于特定的感测参数而启动。在一种实施方式中,可植入泵能够根据程序进度表实现限制装置内的压力变化。
本发明还公开了用于调节可植入限制装置中的压力的方法。在一种实施方式中,该方法可包括感测临床相关参数,根据感测的临床相关参数通过启动与限制装置流体连通的泵来调节可植入限制装置内的压力。在一种实施方式中,泵可由多个致动器形成,在将能量施加在所述致动器上时,所述致动器的形状发生变化,使得多个致动器的顺序激励能有效地产生泵送作用以使流体通过泵。可使用可植入传感器实现对临床相关参数的感测。临床相关参数可以是压力,在这种情况下,可植入传感器是压力传感器。在这样一种实施方式中,将感测的压力与期望的压力范围比较,如果感测的压力不在期望的压力范围内,则将限制装置内的压力调节为基本上在期望的压力范围内。在一种实施方式中,泵可被自动地启动,但是也可想到其它启动技术,包括手动启动技术。
本发明还公开了包括流体管道构件和多个换向致动器(orientation-changing actuator)的泵送装置,贯穿流体管道构件形成有通道,所述多个换向致动器设在流体管道构件内。每个致动器可在正常的松弛状态和通电状态(energized configuration)之间独立地设置,在松弛状态中致动器阻塞流体管道构件的一部分通道,在通电状态下允许流体在致动器的外表面和流体管道构件的内表面之间流动。致动器还可被构造成在将能量施加在其上时改变定向,使得多个致动器的顺序激励有效地产生泵送作用以使流体通过流体管道构件。
致动器可由各种材料构成。在一种示例性实施方式中,每个致动器包括电活性聚合物(EAP)。例如,每个致动器可包括至少一种电活性聚合物复合材料,该电活性聚合物复合材料具有电活性聚合物层、离子凝胶层和至少一个柔性传导层。每个致动器还可包括返回电极和与返回电极连接的传输电极(delivery electrode),传输电极能够传输来自能量源的能量。致动器可被构造成独立地运动或顺序地运动。
本发明更具体地包括以下内容:
(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,其能被调节并且被构造成在患者体内形成限制;和
可植入的泵,其与所述限制装置流体连通并且具有多个致动器,所述多个致动器被构造成在将能量施加到所述多个致动器上时改变形状,使得所述多个致动器的顺序激励有效地产生泵送作用以使流体通过所述可植入的泵。
(2).如第(1)所述的系统,还包括可植入的端口,所述可植入的端口被构造成接收来自患者体外的流体源的流体,其中所述可植入的端口与所述可植入的限制装置和所述可植入的泵流体连通。
(3).如第(1)所述的系统,还包括与所述限制装置通信的可植入的传感器。
(4).如第(3)所述的系统,其中,所述可植入的传感器被构造成至少测量所述限制装置内的压力。
(5).如第(1)所述的系统,其中,所述可植入的泵还包括具有通道并且与所述多个致动器通信的第一构件,所述通道贯穿所述第一构件形成。
(6).如第(5)所述的系统,其中,所述致动器被设置在所述第一构件内。
(7).如第(5)所述的系统,其中,所述致动器被设置在所述第一构件外。
(8).如第(1)所述的系统,其中,至少一个致动器被构造成在将能量施加于其上时扩张。
(9).如第(1)所述的系统,其中,至少一个致动器被构造成在将能量施加于其上时收缩。
(10).如第(1)所述的系统,其中,所述致动器被构造成顺序地运动。
(11).如第(1)项所述的系统,其中,每个致动器包括电活性聚合物。
(12).如第(1)项所述的系统,其中,流体沿着从所述可植入的泵至所述限制装置的方向运动。
(13).如第(1)项所述的系统,其中,流体沿着从所述限制装置至所述可植入的泵的方向运动。
(14).如第(1)项所述的系统,其中,所述可植入的泵根据检测事件和程序进度表中的至少一种实现所述限制装置内的压力变化。
(15).如第(1)项所述的系统,还包括与所述可植入的泵流体连通的流体容器。
(16).如第(15)项所述的系统,其中,所述流体容器被构造成保持范围在大约0.1ml至20ml的流体。
(17).如第(1)项所述的系统,其中,至少一个致动器起到阀的作用,所述阀能够通过允许、阻止或限制流体通过来选择性地控制流体的通过。
(18).一种用于调节可植入的限制装置中的压力的方法,包括:
感测临床相关参数;
响应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来调节所述限制装置内的压力,所述泵由多个致动器构成,所述多个致动器被构造成在将能量施加在其上时改变形状,使得所述多个致动器的顺序激励有效地产生泵送作用以使流体通过所述泵。
(19).如第(18)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。
(20).如第(18)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。
(21).如第(18)项所述的方法,其中,所述泵被自动地启动。
(22).如第(18)项所述的方法,其中,调节所述压力给患者提供了反馈。
(23).如第(20)项所述的方法,还包括将感测的压力与期望的压力范围进行比较,如果所述感测的压力不在所述期望的压力范围内,则将所述限制装置内的压力调节到所述期望的压力范围内。
(24).一种泵送装置,包括:
具有通道的流体管道构件,所述通道贯穿所述流体管道构件形成;和
设置在所述流体管道构件内的多个换向致动器,每个致动器能在正常的松弛状态和通电状态之间独立地设置,在所述松弛状态下所述致动器阻塞所述流体管道构件的一部分通道,在所述通电状态下允许流体在所述致动器的外表面和所述流体管道构件的内表面之间流动,所述致动器被构造成在将能量施加于其上时改变定向,使得所述多个致动器的顺序激励有效地产生泵送作用以使流体通过所述流体管道构件。
(25).如第(24)项所述的装置,其中,每个致动器包括电活性聚合物。
(26).如第(24)项所述的装置,其中,每个致动器包括至少一种电活性聚合物复合材料,所述电活性聚合物复合材料具有电活性聚合物层、离子凝胶层和至少一个柔性传导层。
(27).如第(24)项所述的装置,其中,每个致动器包括返回电极和连接到所述返回电极的传输电极,所述传输电极能够传输来自能量源的能量。
(28).如第(24)项所述的装置,其中,所述致动器被构造成独立地运动。
附图说明
从以下结合附图的详细描述将更加全面地理解本发明,其中:
图1A是食物摄入限制系统的实施方式的示意图;
图1B是图1A的食物摄入限制系统的可植入部分的实施方式的透视图;
图2A是图1A的食物摄入限制装置的透视图;
图2B是图2A的围绕患者的胃食管接合部施加的食物摄入限制装置的示意图;
图3是图1A的注射端口外壳的实施方式的透视图;
图4是图1A的传感器外壳的实施方式的透视图;
图5是根据本发明的一种实施方式的食物摄入限制系统的可植入部分的透视图;
图6A是具有围绕柔性管设置的多个致动器的泵的一种示例性实施方式的透视图;
图6B是图6A的泵的透视图,其中第一致动器被激励;
图6C是图6A的泵的透视图,其中第一和第二致动器被激励;
图6D是图6A的泵的透视图,其中第一致动器被去激励,第二致动器被激励;
图6E是图6A的泵的透视图,其中第二和第三致动器被激励;
图6F是图6A的泵的透视图,其中第二致动器被去激励,第三致动器被激励;
图6G是图6A的泵的透视图,其中第三和第四致动器被激励;
图7是具有围绕包括反作用表面的柔性管设置的多个致动器的泵的一种示例性实施方式的透视图;
图8是具有设置在管形构件内的多个致动器的泵的一种示例性实施方式的透视图;
图9是具有围绕柔性管形构件和在柔性管形构件内设置的致动器的泵的一种示例性实施方式的透视图。
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,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。
本发明总的提供了用于在患者体内形成限制的系统和方法。一般来说,所述系统和方法允许对限制装置中的流体压力或流体体积进行调节。压力或体积的调节通过使用可植入泵来实现。可植入泵允许在无需从外部源增加流体的情况下对限制装置中的流体压力或流体体积进行调节。
虽然本发明可以与现有技术中已知的各种限制系统一起使用,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总的包括可植入部分10a和外部部分10b。图1B示出了在患者体外的可植入部分10a。可植入部分10a包括可调节胃束带20和注射端口外壳30,胃束带20被构造成围绕患者胃40的上部设置,注射端口外壳30例如通过导管50以流体连通的方式连接到可调节胃束带20上。
注射端口外壳30能够允许将流体引入胃束带20或者从胃束带30引出,由此调节束带的尺寸,进而调节施加在胃上的压力。因此,注射端口外壳30可被植入人体内可穿过组织接近的部位处。典型地,注射端口被设置在患者腹部位于皮肤和脂肪组织层下面的侧肋下区域中。外科医生也通常将注射端口植入在患者的胸骨上。
内部部分10a还可包括与该可植入的部分10a中的封闭流路流体连通的感测或测量装置,使得测量装置可进行与可植入限制装置相关的任何参数的测量。这样的临床相关参数包括但不限于温度、压力、压力变化、声输入、组织阻抗、感测的组织阻抗的变化、化学成分、化学成分的变化、脉冲计数、脉冲宽度和脉冲幅度。虽然本文所述的方法和装置涉及感测任何数据参数,但是在一种示例性实施方式中,测量涉及压力,并且本文所述的方法和装置将在对封闭流路的流体压力的测量范围内进行描述。虽然测量装置可具有各种构造并可被设置在沿着内部部分10a的任何地方,包括定位在注射端口外壳30内,但是在示出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相邻设置的传感器外壳60内。导管50可包括连接在胃束带20与传感器外壳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内的流体压力外,食管和/或胃40内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。作为非限制性的例子,所述流体压力测量结果可与在内部部分10a的压力调节之前、过程中和/或之后该内部部分10a内的测量的流体压力进行比较。本领域技术人员可理解食管和/或胃40中的测量压力的其他合适用途。
如在图1A中进一步显示的那样,外部部分10b总的包括压力读取装置70,该压力读取装置70被设置在传感器外壳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。压力读取装置70可任选地与控制箱90(在该实施方式中通过电缆组件80)电通信,该控制箱90可显示压力测量结果,或从压力读取装置70获得的其他数据。
图1B更加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包括可调节的胃束带20、注射端口外壳30、传感器外壳60和泵110,注射端口外壳30以流体连通的方式连接到可调节的胃束带20。泵110可具有各种构造,这在下面将详细描述。在图1B所示的实施方式中,泵110总的包括细长构件112。
图2A更加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与本发明一起使用,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和第二端部20a、20b的支撑结构22,该支撑结构22可彼此连接。各种配合技术可被用于将端部20a、20b彼此连接起来。在示出的实施方式中,端部20a、20b为配合在一起的带子的形式,其中一个端部叠置于另一个之上。胃束带20还可包括可变容积元件,诸如可膨胀囊24,该可膨胀囊24设置在支撑结构22一侧上或在支撑结构22的一侧上形成,并被构造成与组织邻近定位。囊24可相对于胃的外壁膨胀或者收缩,以便形成可调节的人造口,从而以可控方式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,此外,本文中公开的各种方法和装置都可同样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结合入本文中。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,其通过引用结合入本文中。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结合入本文中。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结合本入本文中。
图2B显示了围绕患者的胃食管结合部施加的可调节胃束带20。如图所示,胃束带20至少大体上包围胃40靠近与食管42的结合部的上部。优选以胃束带20中含有少量或者不含流体的收缩构型将胃束带20植入后,胃束带20可例如使用生理盐水膨胀,以缩小人造口开口的尺寸。本领域技术人员将会理解,多种技术,包括机械技术和电技术,都可被用于调节胃束带。图2B还示出了压力传感器41的替代位置,该压力传感器41设置在胃束带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针穿刺隔膜34,该针穿刺隔膜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可包括延伸横跨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。隔膜34优选设置在足够靠近近侧的位置,使容器的深度足以暴露于针(诸如休伯针)的开口尖端,使流体传输可发生。隔膜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,并且隔膜34同样可由任意数目的材料制成,包括硅酮。
如上所述,系统10还可包括与封闭流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)能够评估由胃束带调节形成的限制的效力和功能。如图4中所示,在图示的实施方式中,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地方,并且各种示例性位置和构造在共同拥有的美国专利公布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 AFluid 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进口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内的压力传感器62可以以静态方式或者在泵送流体的同时感测并监控束带的调节状态。
虽然没有显示,但是压力感测系统还可包括微控制器、TET/遥测线圈和电容器。任选地,压力感测系统还可包括温度传感器(未示出)。微控制器、TET/遥测线圈和电容器可通过电路板(未示出)或任何其他适当部件通信。还应当理解,TET/遥测线圈和电容器可共同形成调谐振荡电路,用于接收来自外部部分的功率并且将压力测量结果传输到压力读取装置。
本领域已知的各种压力传感器均可被使用,例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)压力传感器也可得自任何其他来源,包括但不限于:Integrated Sensing Systems(ISSYS)和Remon Medical的感测系统。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。还应当理解,合适的压力传感器可包括但不限于电容式传感器、压阻式传感器、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申请公布No.2006/0189888和No.2006/0199997中更详细地公开,所述文献的内容通过引用而包含于本申请中。通常,压力读取装置70可以非侵入方式测量植入部分内的流体压力,即便在注射端口外壳30或传感器外壳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。医生可抵靠传感器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的显示器上的压力读数。压力读取装置70还可以使用带子、粘合剂和其他公知方法例如在延长的检查过程中以可拆卸的方式连接到患者。压力读取装置70可透过传统的布质或纸质手术单工作,并且还可以包括对于每个患者可更换的一次性的罩(未示出)。
图5示出了可植入限制系统10的可植入部分10a(图1A和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。近端还可包括传感器外壳60以及一个或多个传感器/电源线101。管道50a在可植入部分10a的近端的单个部件之间提供流体连通。导管50在图5所示的可植入部分10a的近端和下游的限制装置20(图1B)之间提供流体连通。虽然图5中所示的部件处于串联构造中,但是本领域技术人员会理解,所述部件可以以任何顺序以及以任何构造连接,例如以T形构造或Y形构造。
如图5所示,注射端口外壳30(如果存在)可任选地包括诸如钩35的锚定装置,该锚定装置可被用于将注射端口外壳30锚定在患者体内。虽然图5示出了外壳30被设置成与容器105、泵110和传感器外壳60串联,但是外壳30可以以其他方式(例如T形构造或Y形构造)连接到其他部件和管道50a上。注射端口外壳30本身是任选的,因为可植入部分10a(图1B)可在植入之前或者在植入时被填充流体。下游的植入装置20(图1B)中的压力可随后通过使用泵110使流体进入或者离开限制装置20来调节。
容器105提供了用于保持额外流体供应的任选部件。例如,容器105可含有0.1ml至20ml的流体。如图所示,容器105可以是管道50a的直径比管道50a的标称直径更大的部分。各种其它构造可被用于提供容器105,诸如与管道50a或任何其它部件(即:注射端口外壳30、泵110或传感器外壳60)连接并且流体连通的分开的容器部件。虽然图5示出了容器105以串联方式设置在泵110和注射端口外壳30之间,但是本领域技术人员能理解,容器105可以以其它方式(例如以T形构造或Y形构造)连接到其它部件和管道50a上。还应当理解,容器105并不必须需要含有足够填满和排空整条束带20(图1A和1B)的流体。例如,在束带20的第一次填充时,流体可经由通过注射端口外壳30的注射而被传输。在这期间,泵110可被保持在打开位置。替代地,容器105可被填充流体,随后可通过泵110将流体传输到束带20。一旦束带20处于功能上充满的状态,即以足以引起摄入限制的方式阻塞胃,容器105可被填充足以在无需通过注射端口外壳30增加额外流体的情况下能满足将来填充和调整需要的流体,本领域技术人员能够理解,容器105是任选的,并且在没有容器105的实施方式中(未示出),管道50a可任选地含有足以允许对束带20中的流体量进行调节的流体。
如图5所示的实施方式包括任选的传感器外壳60,该传感器外壳被设置成与可植入部分10a(图1B)的近端的部件流体连通。虽然图5示出了传感器外壳60被设置成与导管50和管道50a串联,本领域技术人员能够理解,传感器外壳60可以以其它方式(例如T形构造或Y形构造)连接到其它部件。替代地,传感器可被设置在系统中的其它位置上,诸如在束带本身上。传感器/电源线101可在传感器外壳60和泵110之间提供连接以给泵提供能量,如以下更加详细地描述。
可植入泵110的作用在于,使流体进入和离开束带20以根据需要增大或减小束带内的压力。虽然泵可具有各种构造,但是在一个例子中,泵是基于电活性聚合物(EAP)技术的,如以下更详细地描述。使用EAP技术来形成可植入泵110提供了诸多优点,例如尺寸小、电压需求低、功率密度高以及在移动部件的数量上得到简化。
图6A示出了使用EAP致动器的泵送机构的一种示例性实施方式。如图所示,泵110总的包括细长构件112,该细长构件具有近端114、远端116和内部通路或内腔118,该内部通路或内腔118在所述近端114和远端116之间延伸通过细长构件。内腔118限定了流体路径。细长构件112可任选地被形成为管道50a的一部分(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可包括多个致动器122a、122b、122c、122d、122e,这些致动器围绕细长构件112的外表面120设置。在使用中,致动器122a-122e可使用电能来顺序激励,以引起致动器122a-122e径向收缩,从而使细长构件112收缩并且迫使流体沿着一个方向通过细长构件112,如以下更加具体地描述。致动器还可被构造成轴向地收缩和扩张以使流体通过细长构件112。
在替代实施方式中,致动器122a-122e的扩张和收缩可仅仅被用于增大或减小束带内的内部压力,不会使流体实际上运动。在该实施方式中,泵110可被设置在与限制系统流体连通的任何地方。随着能量被施加在致动器122a-122e的一个或多个上,内腔118的容积可被改变,从而在系统10中实现相应的压力变化。
细长构件112可具有各种构造,但是在一种示例性实施方式中,细长构件112是柔性细长管或套管的形式,其被构造成接收从其流过的流体并且被构造成响应于致动器122a-122e的定向变化而弯曲和/或改变尺寸。细长构件112的形状和尺寸,以及用于形成柔性和/或弹性细长构件112的材料可随着预期用途而变化。在一些示例性实施方式中,细长构件112可由生物相容性聚合物(诸如硅酮或胶乳)形成。作为非限制性的例子,其它适当的生物相容性弹性体包括合成聚异戊二烯、氯丁二烯、氟橡胶、腈和氟硅酮。本领域技术人员能够理解,可对材料进行选择,以获得期望的机械性能。虽然没有显示,但是细长构件112还可包括有助于将细长构件112连接到医疗装置、流体源等上的其他特征件。
致动器122a-122e还可具有各种构造。在所示的实施方式中,通过围绕细长构件112的外表面120卷绕的EAP层压材料或复合材料将致动器122a-122e制成环形构件。粘接或其它配合技术可被用于将致动器122a-122e连接到细长构件112上。优选地,致动器122a-122e彼此间隔一定距离,从而当能量被传输到致动器122a-122e时允许致动器122a-122e径向收缩和轴向扩张,但是致动器122a-122e可被设置成彼此接触。本领域技术人员能够理解,致动器122a-122e可替代地设置在细长构件112内,或者它们可与细长构件112形成一体。致动器122a-122e还可以彼此连接以形成细长的管形构件,从而不需要柔性构件112。本领域技术人员还能够理解,虽然示出了五个致动器122a-122e,但是泵110可包括任何数量的致动器(例如从两个到多于五个的变动范围)。例如,致动器的数量和位置可改变,以便控制泵的流动特性和/或压力特性以及泵送作用。致动器122a-122e还可具有各种构造、形状和尺寸,以便改变装置的泵送作用。
如图所示,致动器122a-122e可以以各种定向连接到柔性的细长构件112,以实现期望的流体运动。在示例性实施方式中,致动器122a-122e的定向被设置成,使得致动器122a-122e在被施加能量时径向地收缩和轴向地扩张。具体而言,当能量被传输到致动器122a-122e时,致动器122a-122e的直径可以减小,从而使细长构件112的内径减小。这样的构造允许顺序地激励致动器122a-122e,以将流体泵送通过细长构件112,如以下更具体地描述。本领域技术人员能够理解,各种技术可被用于将能量传输到致动器122a-122e。例如,每个致动器122a-122e可被连接到返回电极和传输电极,该传输电极能够将能量从功率源传递到致动器。电极可延伸通过细长构件112的内腔18,被嵌入在细长构件112的侧壁中,或者可沿着细长构件112的外表面延伸。电极可连接到电池或其它能量源上。如果泵110可被调整而植入患者体内,那么电极可被连接到变换器上,该变换器能够被植入皮下并且能够存储和/或接收来自位于患者体外的外部源的能量。图5示出了示例性实施方式,其中变换器或功率源被包含在传感器外壳60中,并且传感器/电源线101将能量传输给泵110。
替代地,可通过外部装置(例如图1A所示的读取装置70)提供能量,该外部装置可经过皮肤将能量传递到传感器外壳60(图5),例如当外部装置在传感器外壳60附近运动时。外部装置可以是非固定的(例如:可被摇动或者设置在传感器外壳60附近的棒或手持式单元)或固定的(例如:患者能够靠近的床头箱、台式安装箱或车式安装箱)。
图6B-6G示出了用于顺序激励致动器122a-122e以形成蠕动式泵送作用的一种示例性方法。在该示例性实施方式中,泵使流体沿着远侧方向朝着束带运动(图1B),该束带可被设置在泵110的远侧。所述顺序可开始于将能量传输到第一致动器122a,使得致动器压缩细长构件112的一部分并且减小内腔118的直径。在保持至第一致动器122a的能量传输的同时,接着将能量传输至邻近第一致动器122a的第二致动器122b。第二致动器122b径向地收缩(即直径减小),以进一步压缩细长构件112,如图6C所示。因此,内腔118内邻近致动器122a和122b的流体被沿着远侧方向朝着细长构件112的远端116驱使。如图6D所示,在保持至第二致动器122b的能量传输的同时,可以终止至第一致动器122a的能量传输,由此使第一致动器122a径向地扩张并且回复到最初的去激励构造(deactivatedconfiguration)。随后可将能量传输到邻近第二致动器122b的第三致动器122c,以使第三致动器122c径向地收缩,如图6E所示,从而进一步沿着远侧方向推动流体通过内腔118。至第二致动器122b的能量传输随后可被终止,使得第二致动器122b径向地扩张以回复到其最初的去激励构造,如图6F所示。随后可将能量传输到第四致动器122d(图6G所示)以使第四致动器122d径向地收缩,从而进一步沿着远侧方向泵送流体。对相邻致动器的顺序激励和去激励的过程是连续的,形成从泵110的近端114行进到泵110的远端116的“脉冲”。图6B-6G所示的过程在需要时可被重复,以使泵送作用继续。例如,可再次将能量传输到致动器122a-122e以产生第二脉冲。本领域技术人员能够理解,通过在激励最后一个致动器122d的同时激励第一致动器122a,第二脉冲可直接接在第一脉冲后,或者替代地,第二脉冲可接在第一脉冲后不久。本领域技术人员能够进一步理解,上述顺序可被颠倒,以实现沿着近侧方向(即离开束带)的流动。
泵110还可包括被构造用于形成阀的一个或多个致动器。通过使用一个或多个致动器构成阀,束带20(图1B)的流体压力和流体体积可被保持,而无需额外的部件。在一种没有示出的实施方式中,通过将细长构件112的一部分压缩至足以防止流体流过内腔118,致动器122a-122e的至少一个能够形成阀。在该实施方式中,细长构件112通过致动器122a-122e的一个或多个来压缩,直到细长构件112的内壁彼此接触(或彼此靠的很近),从而防止流体流过压缩部分并且由此起到阀的作用。图7-9示出了其中致动器可构成阀的各种其它实施方式。
在图7所示的实施方式中,泵210包括多个致动器222a-222e和反作用表面225,所述致动器222a-222e围绕细长构件212形成,所述反作用表面225可由不可压缩的材料形成并且被设置在细长构件212内。在收缩状态下,致动器222a-222e将细长构件212压靠在反作用表面225上,由此密封内腔并形成阀。与以上相对于图6B-6G描述的致动器相似,致动器222a-222e在它们的松弛或自然构造中处于无压缩状态,因此允许细长构件212的一部分内腔保持打开。当能量被传输到致动器222a-222e时,致动器222a-222e收缩。使用与上述相同的方法,致动器可被顺序地激励,以产生蠕动式泵送作用。当能量被传输至一个或多个致动器(例如如图7所示的致动器222b)时,致动器将细长构件212压靠在反作用表面225上,由此防止流体流过压缩部分,从而起到阀的作用。本领域技术人员能够理解,致动器可替代地被构造,使得致动器在其松弛状态下是关闭的并且将细长构件212压靠在反作用表面225上。随着将能量传输到这样的致动器,致动器会扩张并且允许流体通过腔218的受作用部分。本领域技术人员能够进一步理解,对致动器的激励顺序可被控制以实现沿着近侧方向的流动(即远离束带的流动)或沿着远侧方向的流动(即朝着束带的流动)。
在另一种实施方式中,如图8所示,泵310包括完全设置在细长构件312内的致动器322a-322e。在该实施方式中,致动器322a-322e可以是实心构件形式,该实心构件可以具有各种形状,包括如图所示的圆盘式形状。另外,致动器被构造成当能量被传输到致动器时径向地扩张或收缩。例如,如图8所示,致动器在其松弛状态可以处于扩张形式。在这样的松弛状态下,致动器阻塞细长构件312内的腔318并且防止流体通过腔的受作用部分。但是,当能量被诸如施加到图8中的致动器322d上时,致动器收缩,以允许流体在致动器322d的外表面和细长构件312的相邻内表面之间流动。因此,流体可以流过处于其收缩状态的致动器322a-322e,但是致动器322a-322e形成阀,该阀在致动器322a-322e处于其扩张状态时防止流体流动。蠕动式泵送作用还可通过以上述方式顺序激励和去激励所述致动器322a-322e来产生。本领域技术人员同样能够理解,图8的泵可以替代地被构造,使得致动器在其自然状态下处于压缩构造,由此允许流体流动,并且使得致动器在被施加能量时处于扩张构造。本领域技术人员能进一步理解,致动器的激励顺序可被控制,以实现沿着近侧方向的流动(即远离束带流动)或者沿着远侧方向流动(即朝着束带流动)。
在又一种实施方式中,如图9所示,泵410可包括内部致动器和外部致动器。如图所示,泵410包括完全包含在细长构件412内侧的大致实心的致动器430、440以及形成在细长构件412的外表面上的环形致动器422a-422e。可提供任何数量的内部致动器430、440和外部致动器422a-422e,并且致动器可被形成为任何构造。例如,外部致动器422a-422e可设置在一对内部致动器430、440之间,所述内部致动器430、440可形成泵的终端。在该构造中,内部致动器430、440可作为阀工作,如以上详细地描述。例如,一个内部致动器(例如图9中所示的致动器430)在其松弛状态下可处于扩张形式,以在泵的一个终端密封细长构件412的内腔。使用与上述方法相似的方法,致动器可被顺序地激励,以产生蠕动式泵送作用。例如,在图9所示的构造中,外部致动器422a-422e可如上所述被顺序地激励和去激励,产生行进通过细长构件412的内腔418的流体“脉冲”。外部致动器的顺序激励在需要时可被重复,以使泵送作用继续。本领域技术人员能够理解,内部致动器和外部致动器可具有其它布置和构造。例如,内部致动器430、440可位于每对外部致动器422a-422e之间。另外,本领域技术人员能够理解,致动器的激励和去激励可被控制,以实现沿着近侧方向的流动(即离开束带的流动)或沿着远侧方向的流动(即朝着束带流动)。
本领域技术人员能够理解,虽然在径向收缩和扩张的能力方面对致动器进行描述,但是致动器可替代地被构造成轴向收缩和扩张。
如上所述,在系统中不需要流体容器。替代地,如图6A-9所示的细长构件112、212、312、412还可用作保持额外流体供应的部件。例如,细长构件112、212、312、412的上游侧可具有较大尺寸并且填充额外体积的流体,以满足系统的工作需要。如上所述,对一个或多个致动器的激励可导致流体朝着束带运动或者离开束带运动,所述束带可设置在泵的远侧。本领域技术人员能够理解,在上述实施方式中,致动器的扩张和收缩用于在不使流体实际运动的情况下增加或减少束带内的内部压力,不需要额外的流体体积来实现系统10中的压力变化。
在2005年7月28日提交、题为“Electroactive Polymer-BasedPump”、公开号为No.2007/0025868A1的共同所有的美国专利申请中还公开了关于EAP泵技术的其它信息,该申请通过引用整体结合入本文。
本发明还提供了调节可植入限制系统10中的压力的方法。在一种实施方式中,该方法可包括感测临床相关参数,以及响应于感测的临床相关参数通过启动与限制装置20流体连通的泵来调节限制装置内的压力。基于EAP的泵可以是相对于图6A-9描述的类型。也就是说,泵可以由多个致动器形成,所述致动器被构造成在将能量施加到致动器时改变形状,从而多个致动器的顺序激励有效地产生泵送作用以使流体通过泵。临床相关参数可用于可植入传感器感测。
在一种实施方式中,感测的临床相关参数是压力,但是应当理解,所述参数可包括以上确定的其它参数以及临床上相关的其它参数的任何一种。在该实施方式中,压力可使用可植入压力传感器62感测,如上所述。该方法可包括感测可植入限制装置10a中的压力,将感测的压力与期望的压力(包括期望的压力范围)进行比较,以及如果感测的压力不等于期望的压力(或期望的压力范围),则通过启动与限制装置20流体连通的泵在限制装置中实现期望的压力(或期望的压力范围),由此将限制装置10a内的压力调节到基本等于期望的压力(或期望的压力范围)。
在一种实施方式中,如果在束带20中感测的临床相关参数(例如压力等)高于期望值或期望范围,则泵110的启动可自动地发生,在这种情况下流体可被从束带20泵送出来以减少压力。相反地,如果在束带20中感测地参数低于期望值或期望范围,则流体可被(例如从容器或从可植入导管)泵送入束带中,直到实现参数的期望目标。在又一种实施方式中,如果在束带20中感测的(与不期望的饮食习惯有关的)临床相关参数(例如:给定期间内的绝对压力,压力梯度等)被测量,则流体可被(例如从容器或从可植入导管)泵送进入束带中,直到产生足够的限制为止。该限制可通过生理性响应(例如呕吐等)给患者提供足够的反馈(该反馈可以是立即的或延时的)以停止进食。限制可保持就位直到发生使系统回复到正常工作状态的触发事件(例如消耗时间)为止。出于安全性的目的,提供了可由患者或其它护理者启动的超驰。所述超驰通过食物摄入限制系统10的外部部分10b中的功能件来启动。可使用诸如时钟控制的其它自动启动技术来启动泵,或者可将系统编程为响应于特定感测参数或事件或者根据程序进度表来启动泵。例如,当患者被确定正在进食时,可植入泵可在限制装置中实现压力增加(例如使流体朝着限制装置运动),当患者在睡眠时(或在一天中的选定时间中),可植入泵可在限制装置内实现压力减少(例如使流体离开限制装置)。本领域技术人员能够理解,程序进度表可基于多个参数,包括天的类型(例如假日、工作日、周末),预期的患者活动等等。本领域技术人员能够理解,束带30中的压力可使用诸如PID(比例微积分)控制模式的闭环方法或者包括数字控制模式的其它适当方法来控制。
本领域技术人员能够理解,特定的安全性特征可内置在泵设计中以提供在发生故障或功率损耗时的意外保险(contingencies)。作为例子,如果检测到停电(或故障),或者如果剩余的功率降到预定阈值之下,则系统可被缺省设置成松弛状态,其中限制被松开和/或打开,直到功率水平恢复或者故障被排除。
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,在任何一种情况下,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,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系统并在需要的情况下对其进行清洁。该系统然后可通过任何已知的合适技术(包括乙撑氧消毒技术)消毒。在一种消毒技术中,系统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。容器和系统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。辐射杀死系统上以及容器中的细菌。消毒后的系统然后可被储存在消毒容器中。密封的容器保持系统处于消毒状态,直到其在医学场合下被打开。
优选的是装置被消毒。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引用整体结合在本申请中。
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,其能被调节并且被构造成在患者体内形成限制;和
可植入的泵,其与所述限制装置流体连通并且具有多个致动器,所述多个致动器被构造成在将能量施加到所述多个致动器上时改变形状,使得所述多个致动器的顺序激励有效地产生泵送作用以使流体通过所述可植入的泵。
2.如权利要求1所述的系统,还包括可植入的端口,所述可植入的端口被构造成接收来自患者体外的流体源的流体,其中所述可植入的端口与所述可植入的限制装置和所述可植入的泵流体连通。
3.如权利要求1所述的系统,还包括与所述限制装置通信的可植入的传感器。
4.如权利要求3所述的系统,其中,所述可植入的传感器被构造成至少测量所述限制装置内的压力。
5.如权利要求1所述的系统,其中,所述可植入的泵还包括具有通道并且与所述多个致动器通信的第一构件,所述通道贯穿所述第一构件形成。
6.如权利要求5所述的系统,其中,所述致动器被设置在所述第一构件内。
7.如权利要求5所述的系统,其中,所述致动器被设置在所述第一构件外。
8.如权利要求1所述的系统,其中,至少一个致动器被构造成在将能量施加于其上时扩张。
9.如权利要求1所述的系统,其中,至少一个致动器被构造成在将能量施加于其上时收缩。
10.如权利要求1所述的系统,其中,所述致动器被构造成顺序地运动。
Applications Claiming Priority (2)
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US12/029,806 US8591532B2 (en) | 2008-02-12 | 2008-02-12 | Automatically adjusting band system |
US12/029,806 | 2008-02-12 |
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CN101507668A true CN101507668A (zh) | 2009-08-19 |
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Application Number | Title | Priority Date | Filing Date |
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CNA2009100058001A Pending CN101507668A (zh) | 2008-02-12 | 2009-02-12 | 自动调节的束带系统 |
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US (1) | US8591532B2 (zh) |
EP (1) | EP2090270B1 (zh) |
JP (1) | JP5367397B2 (zh) |
CN (1) | CN101507668A (zh) |
BR (1) | BRPI0903356B8 (zh) |
HK (1) | HK1135893A1 (zh) |
RU (1) | RU2493784C2 (zh) |
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-
2008
- 2008-02-12 US US12/029,806 patent/US8591532B2/en not_active Expired - Fee Related
-
2009
- 2009-02-10 JP JP2009028152A patent/JP5367397B2/ja not_active Expired - Fee Related
- 2009-02-11 RU RU2009104685/14A patent/RU2493784C2/ru not_active IP Right Cessation
- 2009-02-11 EP EP09250333.3A patent/EP2090270B1/en not_active Not-in-force
- 2009-02-12 CN CNA2009100058001A patent/CN101507668A/zh active Pending
- 2009-02-12 BR BRPI0903356A patent/BRPI0903356B8/pt not_active IP Right Cessation
-
2010
- 2010-01-13 HK HK10100354.8A patent/HK1135893A1/zh not_active IP Right Cessation
Also Published As
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US20090204132A1 (en) | 2009-08-13 |
JP2009189809A (ja) | 2009-08-27 |
BRPI0903356A2 (pt) | 2010-06-15 |
BRPI0903356B1 (pt) | 2020-10-06 |
JP5367397B2 (ja) | 2013-12-11 |
US8591532B2 (en) | 2013-11-26 |
BRPI0903356B8 (pt) | 2021-06-22 |
RU2493784C2 (ru) | 2013-09-27 |
EP2090270B1 (en) | 2016-04-06 |
EP2090270A2 (en) | 2009-08-19 |
HK1135893A1 (zh) | 2010-06-18 |
EP2090270A3 (en) | 2013-02-27 |
RU2009104685A (ru) | 2010-08-20 |
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