CN101536940A - 用于诊断胃限制系统的性能的方法和装置 - Google Patents

用于诊断胃限制系统的性能的方法和装置 Download PDF

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CN101536940A
CN101536940A CN200910003262A CN200910003262A CN101536940A CN 101536940 A CN101536940 A CN 101536940A CN 200910003262 A CN200910003262 A CN 200910003262A CN 200910003262 A CN200910003262 A CN 200910003262A CN 101536940 A CN101536940 A CN 101536940A
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D·F·小德卢戈斯
M·S·奥尔蒂茨
A·L·玛科特
R·T·拜鲁姆
D·N·普莱西亚
J·L·哈里斯
M·S·齐纳
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Abstract

本发明提供了用于诊断胃限制系统的性能的方法和装置。一般说来,所述方法和装置可使患者、健康护理员和其他人使用压力数据作为反馈机制来监测可植入限制装置的效力并识别、训练和/或规定治疗计划选项。压力数据监测可在本地被使用和/或远程使用来监测患者体内的限制并将收集的压力数据与该限制的典型压力比较。根据比较的结果,与患者和所述限制有关的可能问题可被识别并诊断出可能原因和解决方案。任何检测的可能问题、原因和/或解决方案的通知可被提供给用户。

Description

用于诊断胃限制系统的性能的方法和装置
技术领域
本发明涉及用于诊断胃限制系统的性能的方法和装置。
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感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。
发明内容
因此,提供了用于可植入的限制装置的方法和装置,特别是用于诊断可植入的限制系统的性能的方法和装置。
本发明总体提供了用于诊断胃限制系统的性能的方法和装置。在一种实施方式中,提供了一种监测患者体内的限制的方法,该方法包括:将所收集的有关被植入到患者体内以形成限制的限制装置的压力数据值序列与患者的压力数据值特征的基线序列进行比较。该方法还包括:如果收集的压力数据值序列相对于基线序列发生变化,则确定引起变化的可能原因,并在一些实施方式中确定建议的校正动作以解决引起变化的可能原因。建议的校正动作可包括下列任何一种:调节设置在限制装置中的流体量,建议患者更完全地咀嚼食物,建议患者寻求医学关注,劝告患者调整饮食,以及劝告患者调整饮食习惯。引起变化的可能原因可以是在限制装置中设置了过多的流体和限制装置中设置了过少的流体中的任何一个。在一些实施方式中,确定引起变化的可能原因可包括:确定收集的压力数据值序列是否包括高于和/或低于包括在基线序列中的压力数据值的压力数据值,收集的压力数据值序列的持续时间是否相对于基线序列的持续时间变化,和/或包括在收集的压力数据值序列中的数据值的频率是否相对于包括在基线序列中的数据值的频率变化。
所述方法可具有任意数目的变型。在一些实施方式中,该方法还包括使用与限制装置相通信的可植入压力测量装置收集压力数据值序列。另一种变型包括将收集的压力数据值序列与患者的过饱水平的记录相关联,而另一种变型包括将收集的压力数据值序列与患者所吃的食物记录相关联并基于该关联确定是否应当建议患者改变进食习惯。该方法还可包括将患者所吃食物的记录与患者的体重减轻趋势相比较,并基于该比较确定是否应当采取校正动作。
在另一种实施方式中,提供了一种监测在患者体内的限制的方法,该方法包括确定被构造成在患者体内形成限制的可植入限制装置中在一段时间内测量的压力是否与该段时间内的预期压力(例如,对于典型患者来说预期的压力,或者使用患者体内的可植入限制装置的历史压力数据产生的压力)不同,如果不同,则启动警报。启动警报可包括在显示装置上显示在该段时间内测量的压力被确定与在该段时间内的预期压力不同的通知。在一些实施方式中,该方法还可包括诊断在该段时间内测量的压力与该段时间内的预期压力不同的至少一种可能原因。将被启动的警报可基于被诊断的至少一种可能原因。
在其他方面,提供了一种用于监测患者体内的限制的系统。该系统包括:压力测量元件,其被构造成测量能够在患者体内形成限制的可植入限制装置中的压力;和处理器,其被构造成将包括由压力测量元件测量的两个或多个压力数据值的压力轮廓线(profile)与用于患者的基线压力轮廓线比较并确定该压力轮廓线是否与基线压力轮廓线不同。在一些实施方式中,如果压力轮廓线与基线压力轮廓线不同,处理器被构造成确定不同的至少一种可能原因以及解决该不同的可能校正动作。基线压力轮廓可包括例如对于患者或者对于典型患者来说与当压力测量元件收集包括在压力轮廓线中的压力数据值时白天的时间对应的白天的时间内的典型压力数据值。
该系统可以各种方式实现。例如,系统还可包括基本单元,该基本单元包括处理器,并且基本单元位于远离患者的位置。在其他实施方式中,系统包括外部存储机构,该外部存储机构包括处理器,并且外部存储机构位于患者本地的位置。在一些实施方式中,系统还包括外部显示装置,该外部显示装置被构造成如果压力轮廓线与基线压力轮廓线不同时提供通知。在一些实施方式中,用户可使用显示装置启动校正动作以解决该不同。在一些实施方式中,系统还包括被构造成存储由压力测量元件测量的压力数据值的存储机构。处理器可从存储机构检索存储的压力数据值,并且在一些实施方式中可被构造成使用从存储机构检索的压力数据值生成压力轮廓线。
更具体地说,本发明涉及如下内容:
(1)、一种监测患者体内的限制的方法,包括:
将有关被植入到患者体内以形成限制的限制装置的收集的压力数据值序列与患者的特征压力数据值的基线序列进行比较;和
如果收集的压力数据值序列相对压力数据值的基线序列发生变化,则确定所述变化的可能原因。
(2)、如第(1)项所述的方法,还包括使用与所述限制装置通信的可植入的压力测量装置收集压力数据值序列。
(3)、如第(1)项所述的方法,还包括使用外部感测系统收集压力数据值序列。
(4)、如第(1)项所述的方法,还包括如果收集的压力数据值序列相对于压力数据值的基线序列变化,则确定建议的校正动作以解决所确定的所述变化的可能原因。
(5)、如第(4)项所述的方法,其中,所述建议的校正动作包括下列任何一种:调节设置在所述限制装置中的流体量,建议患者更完全地咀嚼食物,建议患者寻求医学关注,劝告患者调整饮食,以及劝告患者调整饮食习惯。
(6)、如第(4)项所述的方法,还包括启动警报以提供建议校正动作的通知。
(7)、如第(6)项所述的方法,其中,启动警报包括使用反馈机构将建议的校正动作的通知立即提供给患者。
(8)、如第(1)项所述的方法,其中,所述变化的可能原因是在所述限制装置中设置过多流体和在所述限制装置中设置过少流体中的任何一个。
(9)、如第(1)项所述的方法,其中,确定所述变化的可能原因包括确定收集的压力数据值序列是否包括高于和/或低于包括在压力数据值的基线序列中的压力数据值的压力数据值。
(10)、如第(1)项所述的方法,其中,确定所述变化的可能原因包括确定收集的压力数据值序列的持续时间是否相对于压力数据值的基线序列的持续时间变化。
(11)、如第(1)项所述的方法,其中,确定所述变化的可能原因包括确定包含在收集的压力数据值序列中的数据值的频率是否相对于包含在压力数据值的基线序列中的数据值的频率变化。
(12)、如第(1)项所述的方法,还包括将收集的压力数据值序列与患者饱胀水平的记录相关联。
(13)、如第(1)项所述的方法,还包括将收集的压力数据值序列与患者所吃的食物记录相关联并根据所述关联确定是否应当建议患者改正进食习惯。
(14)、如第(13)项所述的方法,还包括将患者所吃食物的记录与患者的体重减轻趋势相比较,并根据所述比较确定是否应当采取校正动作。
(15)、一种监测在患者体内形成限制的方法,包括:
确定能够在患者体内形成限制的可植入限制装置中在一段时间内测量的压力是否与该段时间内的预期压力不同;并且
如果在该段时间内测量的压力与该段时间内的预期压力不同,则启动警报。
(16)、如第(15)项所述的方法,其中,启动警报包括在显示装置上显示在该段时间内测量的压力被确定与在该段时间内的预期压力不同的通知。
(17)、如第(15)项所述的方法,还包括使用患者体内的可植入限制装置的历史压力数据生成该段时间内的预期压力。
(18)、如第(15)项所述的方法,其中,所述预期压力包括用于典型患者的预期压力。
(19)、如第(15)项所述的方法,还包括诊断在该段时间内测量的压力与该段时间内的预期压力不同的至少一种可能原因。
(20)、如第(19)项所述的方法,还包括根据至少一种诊断的可能原因选择将被启动的警报。
(21)、一种监测患者体内的限制的系统,包括:
压力测量元件,其被构造成测量能够在患者体内形成限制的可植入限制装置中的压力;和
处理器,其被构造成将包括由所述压力测量元件测量的两个或多个压力数据值的压力轮廓线与用于患者的基线压力轮廓线比较并确定所述压力轮廓线是否与所述基线压力轮廓线不同。
(22)、如第(21)项所述的系统,其中,所述基线压力轮廓线包括患者在白天的时间内的典型数据值,该时间与当所述压力测量元件收集包括在所述压力轮廓线中的压力数据值时的白天的时间对应。
(23)、如第(21)项所述的系统,其中,所述基线压力轮廓线包括典型患者在白天的时间内的压力数据值,该时间与当所述压力测量元件收集包括在所述压力轮廓线中的压力数据值时的白天的时间对应。
(24)、如第(21)项所述的系统,还包括包含处理器的基本单元,并且所述基本单元位于远离患者的位置。
(25)、如第(21)项所述的系统,还包括包含处理器的外部存储机构,并且所述外部存储机构位于患者本地的位置。
(26)、如第(21)项所述的系统,还包括外部的显示装置,该显示装置被构造成提供所述压力轮廓线是否与所述基线压力轮廓线不同的通知。
(27)、如第(26)项所述的系统,其中,所述显示装置被构造成允许用户启动校正动作以解决所述不同。
(28)、如第(21)项所述的系统,其中,所述处理器被构造成如果所述压力轮廓线与所述基线压力轮廓线不同,则确定所述不同的至少一种可能原因以及可能的校正动作以解决所述不同。
(29)、如第(21)项所述的系统,还包括被构造成存储由所述压力测量元件测量的压力数据值的存储机构,其中所述处理器被构造成从所述存储机构检索存储的压力数据值。
(30)、如第(29)项所述的系统,其中,所述处理器被构造成使用从所述存储机构中检索的压力数据值生成压力轮廓线。
附图说明
通过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透视图;
图2A是图1A的食物摄入限制装置的透视图;
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透视图;
图4是图1A的传感器外壳的一种实施方式的透视图;
图5示出了图1A的传感器外壳的一种实施方式;
图6是用于图5的压力传感器的变阻电路的实施方式的示意图;
图7是显示图1A的食物摄入限制装置的内部和外部元件的实施方式的框图;
图8是显示用于由图5的压力传感器收集的数据的数据分析方案的实施方式的流程图;
图9是显示图8的数据分析方案的扩展实施方式的流程图;
图10是来自图5的压力传感器的典型压力测量值的图形;
图11是急性过压和图10的典型压力测量值的图形;
图12是慢性过压和图10的典型压力测量值的图形;
图13是意外(sudden)过压和图10的典型压力测量值的图形;
图14是急性欠压和图10的典型压力测量值的图形;
图15是慢性欠压和图10的典型压力测量值的图形;
图16是意外欠压和图10的典型压力测量值的图形;
图17是长持续时间压力和图10的典型压力测量值的图形;
图18是短持续时间压力和图10的典型压力测量值的图形;
图19是过于频繁的压力和图10的典型压力测量值的图形;
图20是过于稀少的压力和图10的典型压力测量值的图形;
图21是偶发性压力和图10的典型压力测量值的图形;
图22是显示图8的数据分析方案的另一种扩展实施方式的流程图;
图23是显示装置的透视图;
图24是用于记录有关图1A的食物摄入限制装置的压力测量值的数据记录器的实施方式的示意图;
图25是显示图24的数据记录器的元件的实施方式的框图;
图26是用于记录有关图1A的食物摄入限制装置的压力测量值的数据记录系统的实施方式的示意图;
图27是显示图26的数据记录系统的元件的实施方式的框图;
图28是带有沿着导管定位的压力传感器的胃束带系统的实施方式的透视图;
图29是带有位于导管内的压力传感器的胃束带系统的实施方式的示意图;
图30是带有沿着导管定位的压力传感器的胃束带系统的另一实施方式的透视图;
图31是带有“T”形压力传感器和导管构造的胃束带系统的实施方式的示意图。
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,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。
本发明总体提供了用于诊断可植入限制系统的性能的装置和方法。一般说来,该装置和方法可使患者、健康护理者和其他人能够使用压力数据作为反馈机制以监测可植入限制装置的效力并识别、训练和/或指定治疗计划选项。压力数据可包括任何压力数据,例如所有压力数据或者仅仅临床相关的压力数据。压力数据监测可在本地使用或者远程使用以监测患者体内的限制并将收集的压力数据与限制的典型压力比较。根据比较的结果,有关患者和限制的可能问题可被识别并诊断可能原因和解决方案。任何检测的可能问题、原因和/或解决方案的通知可被提供给用户。所述数据分析可由此改进患者的治疗计划(包括患者的活动和限制装置的活动)可能问题的检测和响应时间,从而帮助提高限制装置的有效性并增加患者的动力和满意度。例如,当患者吞咽特定食物部分时可获得压力测量值,并根据这种压力反馈的分析,患者可被建议或者教导吃更小的部分,更大的部分或者类似尺寸部分。作为另一个例子,患者可根据压力反馈与部分尺寸和/或根据任何其他参数测试合适的所需食物。在还一种例子中,感测的压力数据的分析可指示限制系统的故障,从而能够迅速识别并处理故障。
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。如图所示,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30。注射端口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,从而调节胃束带20的尺寸并由此调节施加到胃40上的压力。注射端口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中的封闭流路流体连通的感测或测量装置。在一种实施方式中,感测装置为被构造成测量封闭流路的流体压力的压力感测装置。虽然压力感测装置可具有各种构造并可被定位在沿着内部部分10a的任何地方,包括定位在注射端口30中,如在下面进一步描述的那样,在图示的实施方式中压力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与压力传感器外壳60之间的第一部分和连接在压力传感器外壳60与注射端口30之间的第二部分。虽然能够理解,感测装置可被构造成获得与一个或多个相关参数有关的数据(包括有关参数的任何数据,诸如所有未加工数据或者仅仅是临床相关数据),但是总体上其可在本文中被描述为压力感测装置。
除了感测在这里描述的内部部分10a中的流体压力之外,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。作为非限制性的例子,所述流体压力测量可与在内部部分10a的压力调节之前、过程中和/或之后该内部部分10a中的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被构造成定位在压力传感器外壳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压力传感器外壳60通信并由此获得压力测量值。数据读取装置70可任选地与控制箱90(以无线方式或者有线方式,如在该实施方式中经过电缆组件80)电联接,该控制箱90可显示压力测量值,得自数据读取装置70的其他数据,和/或数据警报,如在下面更详细说明的。虽然在该例子中控制箱90显示为相对于患者处于本地,但控制箱90可相对于患者处于本地或者远程位置处。
在一些实施方式中,外部部分10b可包括被构造成获得有关一个或多个相关参数(诸如内部部分10a的封闭流路的流体压力)的数据的感测系统。例如,封闭流路中的压力可通过与注射端口30流体连通的休伯针测量。示例性的外部压力读取系统在题为“ExternalPressure-Based Gastric Band Adjustment System and Method”的美国专利公开No.2006/0211912中描述,其内容通过引用而包含在本申请中。
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,但是在图示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可形成为一个环,使端部彼此连接。各种配合技术可被用于将端部20a、20b彼此连接起来。在图示的实施方式中,端部20a、20b为配合在一起的带子的形式,并且一个叠置于另一个顶部上。在图示的另一种实施方式中,例如在图1B和2B中,在胃束带20一端上的支撑结构可包括开口,胃束带20的另一个端部可穿过该开口,从而将两个端部彼此连接。胃束带20还可包括可变容积元件,诸如可膨胀囊24,该囊设置在支撑结构22一侧上或在支撑结构22一侧上形成,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,从而形成可调节的人造口,以便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。此外,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,如同在美国专利公开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,如同在美国专利公开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,胃束带20至少大体上围绕胃40的靠近与患者食管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紧缩构将胃束带20植入后,胃束带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,多种技术,包括机械技术和电技术,都可被用于调节胃束带20。图2B还示出了感测装置41的替代位置,该感测装置41设置在胃束带20的带扣43中。
流体注射端口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30具有大致圆柱形外壳,该圆柱形外壳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)的入口的针穿刺隔膜34。隔膜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。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、陶瓷、玻璃或者聚合物材料,并且隔膜34同样可由任意数目的自我修复的弹性体材料制成,包括硅树脂。
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,该文献的内容通过引用而包含于本申请中。一般说来,读取装置70可以非侵入方式测量被植入部分10a中的流体压力,即便在压力感测装置被植入到厚(至少超过10cm,并且可能超过15cm)的皮下脂肪组织之下时也是如此。医生可依靠传感器外壳60的位置和/或其他压力感测装置的位置附近的患者皮肤保持读取装置70,获得此处讨论的感测的压力数据和可能的其他信息,并观察控制箱90上的显示器上的压力读数(和/或其他数据)。数据读取装置70还可以使用带子、粘合剂和其他公知方法可拆卸地连接到患者(将在下面进一步讨论),诸如在延长的检查过程中。数据读取装置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)。
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。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 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。
本领域已知的各种压力传感器均可被用作压力传感器62,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,但合适的微机械(MEMS)压力传感器也可得自任何其他来源,包括但不限于:美国密歇根州伊普西兰蒂的Integrated SensingSystems公司(ISSYS)和美国马萨诸塞州沃尔瑟姆的Remon MedicalTechnologies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、压敏电阻传感器、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。
具有设置在其中的传感器62的传感器外壳60的构造的一种实施方式在图5中显示。在该实施例中,传感器外壳60由包括电路板的两件式结构构成,该两件式结构包括用作密封元件(底部)的密封材料和连接到一起的相容性材料的密封顶部,以防止流体与设置在传感器外壳60中除讨论的用于传感器62的那些之外的任何元件接触。传感器外壳60可由适于在体内使用的任何生物相容性材料制成,诸如聚合物、生物相容性金属、陶瓷、玻璃、以及其他相似类型的材料。此外,传感器外壳60可由任何一种或多种透明(如图5所示)、不透明、半透明和不透射线的材料制成。除其他元件以外还包括微控制器65(例如处理器)的电路板64还可设置在外壳60中,以帮助处理并传递由传感器62收集的压力测量值以及与胃束带20有关的其他可能数据。(电路板64还可以是部分外壳60,如上所述。)如同在下面进一步讨论的那样,电路板64还可包括经皮能量传递(TET)/遥感线圈和电容器。任选地,温度传感器可被集成到电路板64中。微控制器65、TET/遥感线圈、电容器和/或温度传感器可经电路板64或者经任何其他合适的元件通信。TET/遥感线圈和电容器可一起形成用于从外部部分10b接收功率并将压力测量值传递到压力读取装置例如读取装置70的调谐振荡电路。此外,如果没有一些辅助手段与压力传感器62相关联的遥感元件不能到达置于患者体外的遥感装置,所述辅助手段可通过任何合适数目的中继器(未显示)或其他装置来提供。
流体可通过定位在外壳表面(这里指其底面)上的任何位置的开口66进入传感器外壳60并与传感器62的压力感测表面68接触。传感器62典型地相对于母板密封,使进入开口66的流体不能渗透并影响压力感测表面68之外的传感器62的操作。当流体流进和流出开口66时,传感器62可测量与压力感测表面68接触的流体的压力。例如,压力感测表面68可包括具有可变形表面的隔膜,使得当流体流过开口66时,流体冲击隔膜的表面,引起所述表面机械位移。隔膜的机械位移可通过包括一对可变电阻、硅应变仪的可变电阻电路转化成电子信号。一个应变仪可与隔膜的中央部分连接以测量隔膜的位移,而匹配的第二应变仪可连接在隔膜的外边缘附近。应变仪可使用粘合剂与隔膜连接或者可融合(diffuse)到隔膜结构中。当胃束带20中的流体压力波动时,隔膜的表面可上下变形,从而在应变仪的中央部分中产生阻抗变化。
用于传感器62的可变电阻电路的一种实施方式在图6中显示。所述电路包括第一应变仪96和第二应变仪98,它们形成半补偿惠斯通电桥电路100的两个顶部电阻元件。当第一应变仪96反应于传感器的隔膜的机械位移时,第一应变仪96的变化阻抗改变了通过电桥电路100的顶部的电势。第二应变仪98与第一应变仪96匹配并使惠斯通电桥电路100隔热(athermalize)。第一差分放大器102和第二差分放大器104与电桥电路100连接以测量由于可变电阻应变仪96、98而引起的电桥电路100中电势的变化。特别是,第一差分放大器102测量通过整个电桥电路100的电压,而第二差分放大器104测量通过电桥电路100的应变仪一半的差分电压。对于通过电桥的固定电压而言,应变仪电压之间的差越大,压差越大。来自差分放大器102、104的输出信号可被应用于集成到电路板64中的微控制器65,并且微控制器65可将测量的压力数据传递到置于患者体外的装置。如果需要,也可使用全补偿惠斯通电桥电路以增加压力传感器62的灵敏性和精确性。在全补偿电桥电路中,四个应变仪而不是仅仅两个应变仪与隔膜的表面连接。
图7示出了包括在内部部分10a和外部部分10b中的元件的一种实施方式。如图7中所示,外部部分10b包括用于将功率信号132传递到内部部分10a的初级TET线圈130。遥感线圈144也被包括用于将数据信号传递到内部部分10a。初级TET线圈130和遥感线圈144组合形成天线,例如读取装置70。例如设置在控制箱90中的外部部分10b包括用于控制应用到初级TET线圈130的功率的TET驱动电路134。TET驱动电路134由具有相关存储器138的微处理器136控制。图形用户界面140与微处理器136连接以便输入患者信息、显示数据和医生指令、和/或打印数据和医生指令。通过用户界面140,用户诸如患者或者临床医生可将调节要求传递给医生并且还传递该要求的提出原因。另外,用户界面140可使患者能够读取并响应来自医生的指令和/或压力测量值警报,如在下面更详细说明的。
外部部分10b还包括初级遥感收发器142,用于将询问指令传递到植入的微控制器65并从微控制器65接收响应数据包括感测的压力数据。初级收发器142与微处理器136电连接以便输入并接收指令和数据信号。初级收发器142驱动遥感线圈144,从而以选定的RF通信频率谐振。谐振电路可生成将指令数据传递到微控制器65的下行交变磁场146。作为替代,收发器142可接收来自内部部分10a中的次级TET/遥感线圈144传递的遥感信号。接收的数据可被存储在与微处理器136相关联的存储器138中。功率源150可为控制箱90提供能量以便为内部部分10a中的元件提供功率。环境压力传感器152与微处理器136连接。微处理器136可使用来自环境压力传感器152的信号以便对于大气压环境下的变化(例如由于气压条件或者高度的变化)调节接收的压力测量值,以便增加压力测量值的精确性。
图7还示出了内部部分10a的元件,在该实施方式中这些元件被包括在传感器外壳60中(例如在电路板64上)。如图7中所示,次级TET/遥感线圈114接收来自外部天线的功率/通信信号132。次级线圈114形成调谐振荡电路,其与初级TET线圈130感应耦合,为植入物或者初级遥感线圈144提供功率以接收和传递数据。遥感收发器158控制与次级线圈114的数据交换。另外,内部部分10a包括整流器/功率调节器160,微控制器65、与微控制器65相关联的存储器162、温度传感器112、压力传感器62和信号调节电路164。植入的元件可将压力测量值(由于温度等而带有或不带有调节部分)从传感器62经天线(初级TET线圈130和遥感线圈144)输送到控制箱90。压力测量值可被存储在存储器138中并被相对于环境压力进行调节、在控制箱90的显示器上显示和/或可能实时传递到患者的远程位置处的远程监测站。
如图8-9中显示的过程的一种实施方式所示,传感器外壳60通常可感测胃束带20中的压力,分析感测的压力数据(例如使用微控制器65)以确定感测的压力数据是否相对于基线或者典型压力发生了变化,并且如果存在变化,则确定变化的至少一种可能原因以及至少一种建议的校正动作以解决确定的变化的可能原因。传感器外壳60还可将警报或者警告提供给控制箱90(例如通过读取装置70),指示变化、可能原因和/或建议的校正动作,控制箱90可将这些提供给用户,例如通过显示警报(例如使用用户界面140)。所述压力变化的检测和诊断可为患者、医生和/或其他用户提供胃束带20的效力的评估(包括校正对于任何不期望的感测数据的可能解决方案,从而允许改进胃束带的功能,在这些问题损害患者信心或者对患者信心产生负面影响之前及时(可能实时)注意问题),和/或其他诊断或者治疗优点。
虽然在图8-9(和后面的图22)中显示的过程参照图1A-7中包括的元件进行讨论,但本领域技术人员将会理解,该过程可被修改以包括更多或更少的元件,被重新组织或者不被重新组织,并可在系统10或者另一种具有其他类似元件的类似系统中执行。例如,在该实施方式中,微控制器65处理指令,但可使用被构造成处理用于系统的指令的任何处理器(例如中央处理单元、微处理器、数字信号处理单元、特定用途集成电路(ASIC)、状态机、模拟计算机、光学或者光子计算机、逻辑电路,等等)。此外,在该图示的实施方式中,传感器62测量流体压力,但任何有关胃束带20的感测压力数据都可如这里讨论的那样被处理。
在使用时,传感器外壳60可使用传感器62感测设置在胃束带20中的流体压力(步骤400)。传感器62可将测量信号例如传递到信号调节电路164(步骤402),该信号调节电路164可在将测量的压力数据传递到微控制器65之前对信号进行放大。作为替代,在一些实施方式中,传感器62可将信号直接传递到微控制器65(步骤402)。在该实施方式中,压力传感器62以大约20Hz的更新速度提供压力数据。这样的更新速度可以大约每50ms完成一个遥感/TET模式循环。例如,TET/遥感线圈114可提供大约45ms的用于传感器外壳60的TET以便为传感器外壳60提供功率并然后提供大约5ms的压力数据的遥感。当然,任何其他切换拓扑学也可被使用。还应当理解,TET和遥感之间的切换不是必须的。例如,传感器外壳60可以是有源的,而不需要TET。作为另一个例子,次级线圈(未显示)可被加入到传感器外壳60中,并且传感器外壳60中的其中一个线圈专用于TET,另一个用于遥感。其他替代和变化对本领域普通技术人员来说是可以想到的,诸如无源遥感方案,诸如在Peter A.Neukomm的题为“Interrogation and Remote Control Device”的WO 89/11701以及P.A.Neukomm和H.Kündig的“Passive WirelessActuator Control and Sensor Signal Transmission”,Sensors and Actuators,vol.A21-A23(1990),pp.258-262中公开的那些。
在已容纳感测的压力数据之后,微控制器65可将数据存储在存储器162中(步骤404)。任何类型的存储器都可被用作存储器162,包括但不限于一个或多个易失性(例如静态随机存取存储器等)、非易失性(例如闪存、硬驱等)或者其他存储器。微控制器65可将感测的压力数据的任何部分或者所有存储在存储器162中。虽然在该实施方式中微控制器65可在分析压力数据之前(见下述)存储压力数据,但如果微控制器65总之将要把数据存储在存储器162中,微控制器65可在分析数据之前和/或之后将压力数据存储在存储器162中。此外,存储器162可被用于存储预先选定的信息或者预先选定的信息类型。例如,存储器162可存储最大压力测量值、最小压力测量值、和/或基线压力测量值、患者吞咽的荧光图像或者视频,和/或任何其他信息。本领域技术人员可想到适于存储在存储器162中的其他信息。
微控制器65(或者在这里描述的任何其他处理器)可以各种方式分析压力数据(步骤406)。典型地,微控制器65分析在一个时间段内测量的压力数据值的序列而不是分析每个离散的压力测量值,从而允许分析经过一段时间的压力趋势并通过不必连续分析新产生的数据而节省处理资源。换言之,微控制器65可将所有感测数据存储在存储器162中并每“X”分钟和/或在收到外部装置的信号时检索和分析存储数据的任何部分。但是,微处理器65可评估单个压力数据测量值(和/或数据范围),以便例如识别无效数据并放弃任何无效数据。
一般说来,在分析压力数据时,微控制器65将感测的压力数据与胃束带20中的基线压力数据进行比较(步骤408),典型地与由传感器62收集压力数据的时间关联(例如早餐、晚餐、晚上12:00到凌晨1:00,下午5:00到下午5:30,周六等)。压力数据例如通过带有时间标记或者通过根据由微控制器65考虑的一个或多个因素确定与特定一餐有关而与白天的时间关联,诸如当传感器62测量数据时白天的时间与高于基线压力数据的压力值的持续时间的组合。基线压力典型地由医生根据患者体内胃束带历史性能、特别是最近植入到典型患者体内的胃束带性能编程到微控制器65中。基线压力因此对于不同患者是变化的,甚至对于单个患者,由于患者体重减轻或者可影响患者的治疗计划的经历变化,基线压力也会发生变化。基线压力典型地表示为经过一段时间的压力,例如对于特定时间段内可以具有或者不具有恒定压力值的曲线。此外,微控制器65可使用先前感测的压力数据、例如存储在存储器162中的数据生成基线压力。
如果测量的压力相对于基线压力变化,则微控制器65可确定可能已引起变化的至少一种可能的问题(步骤410)。微控制器65还可确定至少一种建议的校正动作以解决可能的问题,例如束紧胃束带20,减少热量摄入等(步骤412)。微控制器65可启动给医生、患者和/或任意数目的其他人的警报(步骤414),指示可能的问题和/或建议的校正动作。作为替代,如果测量的压力没有相对于基线压力变化,则内部部分10a中的压力正常,不需要启动警报(步骤414),但在一些实施方式中,可提供正常压力读数的通知。
微控制器65可以各种方式启动警报(步骤414)。微控制器65例如可通过将信号传递到外部装置(例如患者反馈机构,诸如佩戴在患者手腕、腰带等上的外部封装件,或者由患者携带的外部封装件、或患者可利用的外部封装件,包括在植入部分10a中(例如在注射端口30中)的机构,控制箱90,等等)来启动警报,指示可能问题和/或建议的校正动作并启动警报通知。警报可包括下列任何一种或多种:电子邮件、电话、文本信息、听觉信号、机械振动、灯或者其他视觉显示、触觉显示、外部装置上显示的信息或者其他类型的警报。不同警报模式(例如变化的声音信号、变化的振动模式等)可被用于表示不同的状态。两种或多种警报可在类似条件下被提供给多个人,但警报可以不同时提供给多个人或者根本不提供给任何人。警报类型还可相对于检测到的问题和/或警报的接收者而变化。例如,对于用于医生或者其他医护人员的警报,这种警报可被限制为当需要医疗建议或者介入的事件时提供的那些(例如不期望的胃束带压力,不期望的患者进食习惯等),或者表示内部部分10a的一些元件具有结构上的故障(例如导管50纽结、胃束带20泄露等)的那些。对于用于患者的警报,这种警报可被限制为患者活动诸如在指示患者进食次数过少、进食过快或者患者咬嚼的尺寸是否过大时提供的那些。本领域技术人员可想到警报可被引导到医生、患者和/或其他人的各种其他情况。本领域技术人员可想到用于检测警报启动的其他合适过程、警报可被提供的方式、以及提供警报的定时(例如在检测到数据的某些转折点或模式之后,在正常时间表诸如每天或者每小时立即提供)。
压力数据的处理器分析(步骤406)的一种实施方式在图9中显示。作为非限制性的例子,图10显示了示例性的包括多个基线数据值418的基线或者典型压力数据序列416(不是所有数据值都被标记),图11-21显示了示例性的包括微控制器65可从传感器62接收的多个感测数据值422(不是所有的数据值都被标记)的收集或者感测压力数据序列420。在图10-21中显示的压力值和时间仅仅作为例子;压力值可包括在任何时间段内的任何值或者值的范围。本领域技术人员将会理解,基线数据值418可包括先前由传感器62收集的感测数据值422,例如四个小时之前、昨天、上周、上个月等收集的感测数据值。此外,用于患者的基线数据416可例如由于患者增加或减少体重而随着时间变化。虽然压力数据的分析(步骤406)参照图1A-7中包括的元件以及包括在图10-21中的压力数据进行讨论,但本领域技术人员将会理解,这里描述的数据分析可使用任何压力数据以及这些或者类似元件来进行。
一般说来,微控制器65可遵循预编程算法来分析收集的压力数据420(步骤406)。微控制器65可确定感测的压力数据420是否相对于基线压力数据416变化并因此反映非典型压力状态诸如过压、欠压、意外压力脉冲持续时间,或者意外压力脉冲频率。如果感测的压力数据420没有相对于基线压力值416变化,则数据表明感测的压力数据420正常(步骤472)。
更具体地,在分析收集的压力数据420时(步骤406),微控制器65可确定对于一段时间范围内的任何时刻感测的压力数据420是否高于基线压力数据416(步骤424)。虽然在该实施方式中微控制器65首先分析过压,但微控制器65可以任何顺序(不限于参照图9讨论的顺序)分析非典型压力状态的收集的压力数据。如果微控制器65可检测感测的压力数据420中的过压,则微控制器65可确定过压是否作为急性情况存在(步骤426),例如压力中的孤立脉冲尖峰。包括急性过压的感测压力数据420的例子在图11中示出,其中急性过压在时刻11与14之间存在,并且在时刻1-11和14-44过程中感测的压力数据420基本上等于基线压力416。如果急性过压存在,则收集的压力数据420可能表明过大的食物团尺寸或者呕吐,并且相应地建议患者的校正动作是更彻底地咀嚼食物并且患者调整饮食习惯(步骤428)。同所有可能的指示和这里讨论的建议校正动作一样,这些指示和建议的校正动作仅仅作为例子提供,这些或其他指示和校正动作可由微处理器65编程到使用的算法中。如果过压不是急性的,则微控制器65可确定过压是否是慢性的,例如在被分析的时间范围内持续(步骤430)。如果是慢性的,如图12所示,则收集的压力数据420可能表示胃束带20过紧或者患者体重增加,并且在任一情况下建议胃束带调节的校正动作(步骤432)。如果过压存在但不是急性的或者不是慢性的,则过压可能表示压力意外(sudden)增加超过预期基线并随后持续,诸如在图13中显示的那样,其中意外过压在时刻70开始(步骤434)。意外过压可能表示内部的问题,诸如填充管纽结、胃束带20起皱,或者靠近胃束带20的组织的移动,建议的校正动作是看医生,以便对患者进行检查并可能进行胃束带调节。
微控制器65还可确定对于一段时间范围内的任何时刻感测的压力数据420是否低于基线压力数据416(步骤436)。如果微控制器65可检测感测的压力数据420中欠压,则微控制器65可确定欠压是否作为急性情况存在,例如压力中的孤立下降(步骤438)。包括急性欠压的感测压力数据420的例子在图14中示出,其中急性欠压在时刻52与87之间存在,并且其他时刻感测的压力数据420基本上等于基线压力416。如果急性欠压存在,则收集的压力数据420可能表明患者消耗液体卡路里,建议患者调整饮食的校正动作,例如增加固体食物的消耗(步骤440)。如果欠压不是急性的,则微控制器65可确定欠压是否是慢性的(步骤442)。如果是慢性的,如图15所示,则收集的压力数据420可能表示胃束带20过松或者患者体重减轻,并且在任一情况下建议胃束带调节的校正动作(步骤444)。如果欠压存在但不是急性的或者不是慢性的,则欠压可能表示压力意外降低到低于预期基线并随后持续,诸如在图16中显示的那样,其中意外欠压在时刻70开始(步骤446)。意外欠压可能表示内部的问题,诸如胃束带20泄露,建议的校正动作是看医生,以便对患者进行检查并可能进行胃束带调节。
微控制器65还可确定感测的蠕动脉冲持续时间是否相对于基线变化(步骤448)。如果微控制器65检测到蠕动脉冲的不期望的持续时间,则微控制器65可确定蠕动脉冲持续时间是否过长(步骤450),例如,持续时间是否如同超过典型压力数据416的预期结束时间的感测的正向压力数据值422的存在表示的那样过分地长。过长压力数据420在图17中示出,其中感测的蠕动脉冲在时刻42之后继续超过基线数据416。如果蠕动脉冲的持续时间过长,则收集的压力数据420可能表示不正确的食物量(例如消耗的固体食物不足,浆状食物(pureed food)的消耗等等),或者不正确的饮食习惯,并且建议的相应地校正动作包括患者调整饮食(例如增加固体食物的消耗)并调整饮食习惯(例如采用更短的进食时间段)(步骤452)。如果蠕动脉冲的持续时间过短,诸如如图18中所示,则收集的压力数据420可能表示不正确的饮食习惯,并且建议的校正动作包括患者调整饮食习惯(例如采用更长的时间段进食)(步骤454)。
微处理器65还可确定感测的压力数据值420是否具有相对于基线数据值418变化的频率,例如与基线数据值418相比感测的数据值420在一段时间内是否分布不规则(步骤456)。如果微控制器65检测到感测数据值422的不期望的频率,则微控制器65可确定感测的压力数据值422是否发生的过于频繁(步骤458)。过于频繁的压力数据420的例子在图19中示出。如果感测的压力数据420的频率过高,则感测的压力数据420可能表示患者吃得过于频繁或者在进餐过程中吃得过多,并在任一种情况下建议校正动作包括患者调整饮食习惯(例如吃得不那么频繁,每餐吃较少的食物等等)(步骤460)。如果数据频率没有过量,则微控制器65可确定感测的压力数据值422是否发生得过少(步骤462)。如果是发生的过少,如图20中所示,则收集的压力数据420可表示患者吃的次数过少或者在进餐时没有吃足够的食物,并在任一种情况下建议校正动作包括患者调整饮食习惯(例如吃得频繁一点,每餐吃更多的食物等等)(步骤464)。如果感测的数据值422的频率既不过高也不过低,则微处理器65可确定感测的压力数据值422是否是偶发性的,例如以不规律的频率发生(步骤466)。如果感测的压力数据420不规律,则收集的压力数据420可能表示患者不规律地进食,并建议患者调整饮食习惯的校正动作(例如以有规律的间隔进食)(步骤468)。如果感测的数据值422的频率不典型、但也不过高、过低或者不规律时,则非典型频率可能表示进食频率的意外变化(步骤470),例如图21中所示。这种意外的频率变化可能表示内部问题(例如胃束带20过紧或者过松)或者患者体重的变化(增加或减少),所有这些的建议的校正动作都是看医生,以便对患者进行检查和可能的胃束带调节。
在分析感测的压力数据420时(步骤406),微控制器65可放弃有关一个或多个生理事件的感测压力数据420,并且不确定所述数据表示问题,尽管其显示与基线数据420不一致。生理事件的非限制性的例子包括超常事件(例如咳嗽、呕吐、扭伤(wretching)等等)和正常事件(心跳等)。生理事件可导致在幅值、持续时间、发生(例如一天中不期望的时间,诸如午夜)和/或频率方面与建立的患者进食模式的预期水平显著不同的测量压力数据。微控制器65可通过分析对于这样的明显不同的数据来确定保留收集的压力数据,诸如通过确定任何获得的压力数据是否包括高于预编程阈值的值,该预编程阈值除了响应于生理事件外通常不被超过。微控制器65还可确定或者替代地确定任何获得的压力数据是否包括压力值的限定范围内的值。根据限定的范围,微控制器65可确定放弃该范围内的数据(例如,如果该范围反映了由正常事件引起的预期频率和幅值的压力读数)或者保留该范围内的数据(例如如果该范围包括达到除生理事件外通常不被超过的阈值的任何正的压力值)。
微控制器65可另外分析用于非典型压力状态的压力数据或者作为其替代,微控制器65可考虑除分析收集的压力数据中的压力(步骤406)之外的一个或多个变量。考虑所述变量的分析过程的一种实施方式在图22中显示。在分析感测的压力数据420时(步骤406),微控制器65可获得与患者有关的变量数据,诸如患者饱胀水平的记录或者患者进食的食物的记录(步骤476)。微控制器65可以各种方式获得变量数据(步骤476)。例如,患者可在一天中一次或多次(例如以规律的间隔,进餐之前或之后的某一段时间等等)将有关他们的饱胀水平的信息输入到输入装置诸如有线或无线手持式显示装置600中,该显示装置600的一种实施方式在图23中显示。患者可例如根据使用一表示饥饿、三表示未吃饱、五表示吃好、七表示吃饱以及九表示过饱的尺度输入与他们当前饱胀水平对应的数。作为另一个例子,患者可在一定时间(例如特定时刻或者白天的时间)将有关所吃食物类型的信息输入到输入装置诸如手持式装置600中。患者可输入与特定食物类型(例如一表示固体,二表示液体等)对应的数,从提供的特定食物或食物类型清单中选择食物类型,获取将要吃的食物图片并将其上传到输入装置中等等。
在任意数目的输入循环(例如每天,每12小时,由患者指示或者由标准时间表指示的白天的最后输入之后,每周等等)过程中,微控制器65可将一定时刻或者时间范围的感测的压力数据420与对应于该特定时刻或者时间范围的输入变量数据相关联(步骤476)。所述关联可涉及微控制器65“学习”变量输入与压力数据之间的基线关联。与上述分析类似,微控制器65可确定是否建议校正动作(步骤478),在这种情况下微控制器65可如上所述启动警报(步骤414)。例如,微控制器65可根据与由患者输入的一定饱胀水平对应的先前压力数据基本上等于的收集的压力数据420(例如实时收集的压力数据)启动指示患者已经吃得足够的警报(步骤414)。作为另一个例子,微控制器65可启动警报(步骤414),该警报指示可能存在的问题,医生应当与患者协商,因为对于在一定数量的输入循环过程中基本上相等的压力测量值,输入饱胀水平是变化的。作为再一种例子,与液体食物相反,固体食物诸如面包和肉通常产生具有更高的幅值峰值、更多峰值和每个峰值的更长持续时间的压力数据420,因为患者的身体工作,以使消耗的食物运动经过由胃束带20引起的限制。微处理器65可根据输入的食物类型和测量的压力水平“学习”识别这种“食物指纹(fingerprint)”,用于随后测量的大致相同的压力数据,根据先前(现在为基线)数据确定建议的校正动作。这样,如果收集的压力数据420基本上等于与可被修改(例如更多地咀嚼食物,吃更多固体食物等)的食物输入记录对应的先前压力测量值,微控制器65可启动警报(步骤414),建议的校正动作是改变患者饮食习惯。
如上所述,由传感器62收集的数据(由微控制器65分析或者没有被分析的)可被上传到外部单元诸如控制箱90(和/或定位在患者本地或者远离患者的其他单元),以允许人们以物理方式评估和/或控制箱90以电子方式评估在指定时间段内患者的治疗和/或包括在内部部分10a中的元件的性能。在一些实施方式中,包括在限制系统10的外部部分10b中的处理器(例如微处理器136)可接收由传感器62收集的数据(步骤402),存储由传感器62收集的数据(步骤404)和/或分析由传感器62收集的数据(步骤406)。如果需要,所述外部处理器还可启动警报(步骤414)。
存储在可植入存储器162中的数据可以各种方式传递到外部装置。在一些实施方式中,微控制器65连续传送数据(经遥感收发器158和次级线圈114),并且仅仅当合适的接收装置诸如天线(初级TET线圈130和遥感线圈144)运动到与其足够接近时数据才被接收。在一些实施方式中,当外部装置(例如读取装置70)以遥感方式提供功率给传感器外壳时,例如当外部装置运动到传感器外壳60附近时,从存储器162下载数据可被启动。外部装置可以是运动的(例如可被摇动或者放置在传感器外壳60附近的棒或者手持单元)或者是固定的(例如床边箱、台式安装箱或者患者可运动到其附近的车载箱)。为传感器外壳60以遥感方式提供功率可节省内部部分10a中的功率,因为下载通信功率由外部部分10b提供。
外部装置可被构造成存储从传感器外壳60接收到的数据。外部装置可进一步被构造成将数据传递到其他外部装置诸如远离患者的位置处的基础单元。外部装置(典型地为控制箱90,或者具有显示或者提供警报能力的其他装置诸如手持式显示装置600)可检测内部部分10a是否传传递指示警报的信号并在适当时候提供警报(例如显示报警通知,发送电子邮件信息等)。
图24示出了外部装置-数据记录器270的实施方式,其可包括可分析一段时间内压力测量值的处理器。数据记录器270可用作可拆卸地连接的数据读取装置70,如上所述。在该例子中,数据记录器270包括可穿戴封装件,该封装件外置于患者穿戴的带子274上并定位在如下区域上方或该区域的通信范围内,在所述区域下方传感器外壳60植入患者体内。作为替代,数据记录器270可围绕在患者的脖子上佩戴,如图由装置270’所示,诸如当注射端口30被植入到患者的胸骨上并且注射端口30包括压力感测装置时。在另一种实施方式中,数据记录器270还可被植入到患者体内。
如图24所示,数据记录器270包括TET线圈285和遥感线圈272,它们可由患者穿戴以便与内部部分10a靠近地定位。TET线圈285可为植入物提供功率,而遥感线圈272可询问植入物并可通过植入部分10a中的次级遥感线圈114接收数据信号,包括压力测量值。在另一种实施方式中,TET线圈285和遥感线圈272可被结合成单个线圈并可以任何合适的速率在TET和遥感功能之间交替任何合适的持续时间。
胃束带20中的压力可被反复感测并以足以测量抵靠胃束带20的蠕动脉冲的更新速率传递到数据记录器270。典型地,该更新速率在每秒5-20个压力测量值的范围内,但任何更新速率范围均可被使用。数据记录器270通常在醒着的阶段内穿戴以记录在患者进食和日常生活过程中的压力变化。在一天结束时,或者在其他设定时间段结束时,数据记录器270可被除去并且记录的压力数据被下载到外部存储器138中。压力历史可在随后的通信期间经一个或多个通信连接装置从存储器138上传到远程单元。作为替代,压力数据可使用一个或多个通信连接装置直接从数据记录器270上传到远程单元。通信连接装置可包括任何单个数据传递媒体或者组合的两个或多个数据传递媒体,包括利用高速电缆或者拨号连接的基于网络的系统,公用电话线、无线RF网络、蓝牙、超宽带(UWB)、人造卫星、T1线或者适于在远程位置之间传递数据的任何其他类型的通信媒体。数据记录器270可被构造成对接到另一装置中,例如对接站,所述装置被构造成接收与数据记录器270的通信数据并将接收的数据传递到远程单元。
图25更详细显示了数据记录器270。如图25所示,数据记录器270包括用于进行如上所述的分析和/或用于控制与内部部分10a遥感通信的微处理器276。微处理器276与存储器280连接,以便至少存储来自内部部分10a的压力测量值。在该实施方式中,存储器280包括40MB的非易失性的电可擦除只读存储器(EEPROM)或者闪存并被构造成存储大约100小时的带时间标记的压力数据,但存储的任何其他类型也可被使用,并且存储器280可存储任意量和任何类型的数据。作为非限制性的例子,任何其他类型的易失性存储器或者任何其他类型的非易失性存储器都可被使用。虽然在该例子中数据记录器270是可操作的,但压力可以由微处理器276控制的指定数据速度被读取并存储在存储器280中。
微处理器276可由功率源282提供能量。在一种实施方式中,功率源282包括充电电池(未显示),诸如充电电池组。在一些实施方式中,充电电池可拆卸并可使用充电单元充电并在对用过的电池充电时以其他充电电池替换。在其他实施方式中,充电电池可通过将充电适配器插入到数据记录器270中和墙壁插座中而被充电。在还一种实施方式中,充电电池可通过无线充电单元无线充电。在又一种实施方式中,功率源282包括超电容器,其也可被充电。当然,任何其他类型的功率源都可被使用。
为了记录压力,微处理器276可最初经TET驱动电路283和TET线圈285将功率信号传递到内部部分10a。在传递功率信号之后,微处理器276可经遥感收发器284和遥感线圈272将询问信号传递到内部部分10a。询问信号可由遥感线圈114截取并传递到微控制器65。微控制器65可经收发器158和次级遥感线圈114发送来自传感器62的响应的任选温度调节的压力读数。压力读数可通过遥感线圈272被接收并由收发器284引导到微处理器276。微处理器276可在其相关联的存储器280中存储压力测量值并启动下一询问要求。如果微处理器276能够启动警报(除了或者代替微处理器276和/或其他处理器),微处理器276还可对由微控制器65识别的警报产生响应,诸如使用视觉警报(例如在数据记录器270上闪烁的灯,将信息显示在用户界面292上等)和/或听觉警报。用户界面292可包括任意数目和类型的元件,包括但不限于扬声器、发光二极管、液晶显示器、通/断开关等。在一些实施方式中,用户界面292被构造成仅仅将输出提供给患者并且不允许患者对数据记录器270进行输入。用户界面292因此包括当功率源282充分充电时点亮的发光二极管,和当功率源282需要被充电时点亮的另一个不同颜色的发光二极管,尽管这种功率指示器可使用任何类型和任意组合的指示器,诸如在低功率时发光的一盏灯、听觉警报,电子邮件警报等。在其他实施方式中,用户界面292可允许患者对数据记录器270进行输入并可相应地包括任何合适的元件和零件。
当结束测量和记录压力时,数据记录器270可从患者身上和/或从带子274上除去并且记录的压力数据被下载到控制箱90(和/或任何其他外部装置)。数据记录器270可包括使用通信连接装置将感测的压力数据直接传递到远程基本单元的调制解调器286。例如,患者可将调制解调器286与电话线(或者其他通信连接装置)连接,对医生的调制解调器拨号(如果需要的话),并选择用户界面292上的“发送”按钮。一旦接通,微处理器276可通过电话线将存储的压力历史和/或压力数据分析传递到包括在远程单元中的处理器中。作为替代,数据记录器270可包括用于将记录器270与控制箱90连接的USB端口290。记录器USB端口290可与包括在控制箱90上的USB端口连接并且“发送”开关被启动以将压力数据下载到控制箱90中的存储器138中。在压力数据被下载之后,数据记录器270可通过用户界面292关闭或者重设并重新设置在患者和/或带子274上以便继续进行压力测量。
数据记录系统300的替代实施方式在图26中显示。在该例子中,数据记录系统300包括线圈头(coil head)354和数据记录器370。线圈头354和数据记录器370经可拆卸的电缆356连接。任何一个或多个合适的替代通信连接装置可被用于替代电缆356,包括但不限于无线发射机/接收机系统。在图示的实施方式中,线圈头354被穿戴在患者的脖子周围并通常定位在注射端口30上方并在传感器外壳60的通信范围内。数据记录器370佩戴在围绕患者腰部的带子274上。当然,这些相应的位置仅仅是示例性的,线圈头354或者数据记录器370或者它们两者可被定位在任何地方。作为非限制性的例子,当注射端口30被植入到患者腹部时,线圈头354可佩戴在带子274上。线圈头354和数据记录器370在图26中简单地表示为方框,仅仅用于说明的目的,线圈头354或者数据记录器370可以各种形状、尺寸和构造被提供。
数据记录系统300的示例性元件在图27中显示。如图所示,数据记录器370包括微处理器276,存储器280,功率源282,USB端口290以及用户界面292。线圈头354包括TET驱动电路283,遥感收发器284、TET线圈285和遥感线圈272。TET驱动电路283被构造成经电缆356从功率源282接收功率。TET驱动电路283进一步被构造成经电缆356从微处理器276接收信号。遥感收发器284被构造成经电缆356从微处理器276接收信号并将信号传递到微处理器276。在另一种实施方式中,遥感收发器284被构造成仅仅将信号传递到微处理器276。上述参照图25对所述元件的讨论也可被应用于图27中显示的元件。在图27中示出的实施方式中,线圈头354和数据记录器370可被视为将包括数据记录器270(见上述)的元件分成两个物理上分离的单元。本领域技术人员能够理解,图27中显示的任何元件以及它们的关系、功能等都可以任何合适的方式变化。
在本例子中,线圈头354被构造成与上面描述的天线(初级TET线圈130和遥感线圈144)类似并且以与其类似的方式起作用。线圈头354的TET线圈285被构造成为注射端口30提供功率。当然,如果被植入到患者体内的任何其他装置(例如泵等)被构造成从TET线圈285接收功率,TET线圈285也可为这样的装置提供功率。由TET线圈285提供的功率可通过TET驱动电路283提供到TET线圈285并由TET驱动电路283调节,该TET驱动电路283本身可经电缆356从功率源282接收功率。这种提供到TET驱动电路283的功率可经电缆356由微处理器276调节。另外或者作为替代,微处理器276可调节TET驱动电路283为TET线圈285提供功率的方式。虽然本例子设想了通过TET线圈285的RF发送信号的使用,但任何其他类型的提供功率的技术以及替代的功率通信都可被使用。本领域技术人员可想到这些元件之间的其他合适构造和关系以及它们可操作的替代方式。
线圈头354的遥感线圈272被构造成从线圈114接收信号,包括指示植入的胃束带系统中的压力(例如注射端口30中的流体压力,导管50中的压力,和/或可调节胃束带20中的压力,使用压力传感器62获取的压力等)的信号和指示温度的信号。遥感线圈272还可从任何其他任何来源接收表示任何其他类型的信息的任何其他类型的信号。由遥感线圈272接收的信号可被传递到遥感收发器284,遥感收发器284可经电缆356将所述信号传递到微处理器276。遥感收发器284可在将信号传递到微处理器276之前执行对从遥感线圈272接收的信号的翻译或者处理。其他合适的构造和这些元件之间的关系以及它们可操作的替代方式可由本领域技术人员理解。还应当理解,元件可被组合。作为非限制性的例子,TET线圈285和遥感线圈272可被结合成单个线圈并可以任何合适的速率在TET和遥感功能之间交替任何合适的持续时间。另外,虽然本例子设想了通过遥感线圈272的RF发送信号的使用,但应当理解,任何其他类型的通信技术(例如超声、磁等)以及与线圈不同的替代通信装置可被使用。
在一种示例性使用中,患者整个白天穿戴线圈头354和数据记录器370,以便将压力测量值记录在存储器280中。在夜间,患者可将数据记录器370从线圈头354上拆下并将数据记录器370与对接站例如控制箱90联接在一起。在数据记录器370和控制箱90被联接时,控制箱90可将从数据记录器370接收的数据传递到远程单元。如果功率源282包括充电电池,在数据记录器370与控制箱90联接时,控制箱90可对电池充电。但是,患者不必为了将数据记录器370联接到控制箱90而将数据记录器370与线圈头354拆开。此外,除了在白天记录和/或分析这种压力测量值之外,或者作为在白天记录和/或分析这种压力测量值的替代,在夜间可将所述压力测量值记录在存储器280中和/或通过微处理器276分析,并且压力测量值可在一天内24小时记录。在该方式中,压力测量值的获取、记录和分析的定时不必仅仅被限制为白天的时间。
如上所述,数据记录器370可接收、存储、分析并传递与限制系统中的压力有关的数据。但是,数据记录器370可接收、存储、分析和/或传递各种其他类型的数据。作为非限制性的例子,数据记录器370还可接收、处理、存储、分析和/或传递有关温度、心电图(EKG)测量值、患者的进食频率、由患者进食的食物的尺寸、患者散步的量等数据。因此本领域技术人员能够理解,数据记录器370可被构造成处理接收到的数据以建立另外的数据以便传递到控制箱90。例如,数据记录器370可处理经线圈头354获取的压力数据以建立指示患者的进食频率的数据。本领域技术人员还能够理解,数据记录器370可包括另外的元件以获取非压力数据。例如,数据记录器370可包括计步器或加速计(未显示)以获取有关患者散步的量的数据。由所述另外的元件获取的数据可被存储在存储器280中并以与压力数据类似的方式传递到控制箱90。数据记录器370还可包括用于获得将与内部压力测量值一起作为因子被考虑(factored)的数据以说明各种条件对压力的影响的元件。例如,数据记录器370可包括用于测量大气压的气压计。在一些实施方式中,数据记录器370包括倾斜计或者类似装置以确定患者的朝向(例如站立、躺下等)的角度,其可被作为因子考虑进压力数据以说明由患者的朝向引起的静压力的影响。作为替代,用于获得非压力数据的倾斜计或者其他装置可与数据记录器370物理分离(例如被植入)。本领域技术人员可理解,还有其他类型的数据、所述数据可被获得的方式以及所述数据被使用的方式。
虽然上面描述的实施方式包括在可拆卸地连接到导管50的传感器外壳60中的压力传感器62的使用,但是压力传感器可被定位在患者体内的任何地方。例如,压力传感器62可被包括在端口外壳30中。在图28中显示的另一种实施方式中,压力传感器500可被定位在胃束带502中,诸如胃束带502的可膨胀部分中。如果胃束带502包括弹性部分和非弹性部分,压力传感器500可被连接到弹性部分或者非弹性部分,或者与两者都不连接。在任何情况下,压力传感器500可在经注射端口501和导管503向胃束带502中加入流体或者从胃束带502中抽出流体之前、过程中和之后感测胃束带502中的流体压力并传递该流体压力。当泵(未显示)或者任何其他装置被用于调节胃束带502中的压力时,压力传感器500可被使用。
作为替代,如图29中所示,压力传感器504可被定位在位于胃束带508与注射端口507之间的导管506中、泵、容器或者与导管506流体连通的其他装置中。作为另一种变型,在图30中显示的例子,压力传感器509可与导管506串联固定连接,而不保留在导管506中。
在图31中显示了又一种变型,其示出了具有“T”形交叉部550的导管506。压力传感器504设置在与导管506垂直并与导管506流体连通的“T”形交叉部550的臂中。在一种实施方式中,“T”形交叉部550与导管506一体形成(如图所示)。在另一种实施方式中,“T”形交叉部550是与导管506连接(例如使用带倒刺的连接器等)的独立元件。本领域技术人员可想到“T”形交叉部550可被提供的其他合适的方式。类似地,本领域技术人员可想到压力传感器504可被设置到导管506中、与导管506串联或者与导管506相邻的其他方式。
在还一种实施方式中(未显示),压力传感器可被定位在注射端口与导管的界面处,和/或在胃束带与导管的界面处。本领域技术人员可想到压力传感器的其他合适的位置,包括但不限于胃束带系统的流路中的任何位置或者与之相邻的任何位置。另外,压力传感器可被定位在胃束带中(例如抵靠胃束带的内壁)、导管中和带扣中,或者作为替代,所述胃束带、导管和带扣的一部分可包括从其向外延伸的突起,以便容纳相应的压力传感器的至少一部分。本领域技术人员可想到用于将压力传感器容纳在胃束带中、导管中或带扣中或者与之相邻的其他合适构造。
在另一种实施方式中,可使用多个压力传感器。例如,除了与胃束带流体连通的导管中的压力传感器之外,胃束带系统还可包括处于胃束带中的压力传感器。所述多个压力传感器可提供流体压力在胃束带系统的元件中分布情况的指示。所述多个压力传感器还可提供更精确的压力读数、减小影响压力读数的导管阻塞(例如夹紧)的可能性、减小来自患者运动的静压力变化的影响、和/或提供一个或多个其他结果。除了任何上述植入的压力传感器之外,包括多个压力传感器的任何系统可包括处于注射端口外壳中的压力传感器和/或在患者体外的压力传感器(例如在注射器中的压力传感器或者在与注射器连接的压力传感器部分中的压力传感器)。此外,装置诸如内部或者外部倾斜计(或者其替代物)可被用于确定患者和/或内部部分的朝向(例如直立、躺下等)的角度,其可被作为因子考虑到由一个或多个传感器感测的压力数据中以说明由患者的朝向引起的静压力的影响。这样的因子(或者任何其他因子)可在进行压力读取之前或者与其结合被说明。
本领域技术人员将会理解,本发明可应用于传统内窥镜和开放式外科器械中,以及应用于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,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、一种监测患者体内的限制的方法,包括:
将有关被植入到患者体内以形成限制的限制装置的收集的压力数据值序列与患者的特征压力数据值的基线序列进行比较;和
如果收集的压力数据值序列相对压力数据值的基线序列发生变化,则确定所述变化的可能原因。
2、如权利要求1所述的方法,还包括使用与所述限制装置通信的可植入的压力测量装置收集压力数据值序列。
3、如权利要求1所述的方法,还包括使用外部感测系统收集压力数据值序列。
4、如权利要求1所述的方法,还包括如果收集的压力数据值序列相对于压力数据值的基线序列变化,则确定建议的校正动作以解决所确定的所述变化的可能原因。
5、如权利要求4所述的方法,其中,所述建议的校正动作包括下列任何一种:调节设置在所述限制装置中的流体量,建议患者更完全地咀嚼食物,建议患者寻求医学关注,劝告患者调整饮食,以及劝告患者调整饮食习惯。
6、如权利要求4所述的方法,还包括启动警报以提供建议校正动作的通知。
7、如权利要求6所述的方法,其中,启动警报包括使用反馈机构将建议的校正动作的通知立即提供给患者。
8、如权利要求1所述的方法,其中,所述变化的可能原因是在所述限制装置中设置过多流体和在所述限制装置中设置过少流体中的任何一个。
9、如权利要求1所述的方法,其中,确定所述变化的可能原因包括确定收集的压力数据值序列是否包括高于和/或低于包括在压力数据值的基线序列中的压力数据值的压力数据值。
10、如权利要求1所述的方法,其中,确定所述变化的可能原因包括确定收集的压力数据值序列的持续时间是否相对于压力数据值的基线序列的持续时间变化。
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EP2082707A2 (en) 2009-07-29
JP2009178550A (ja) 2009-08-13
EP2082707B1 (en) 2015-10-28
JP5410104B2 (ja) 2014-02-05
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