CN101612036A - 对可植入限制装置和数据记录器的生理参数分析 - Google Patents
对可植入限制装置和数据记录器的生理参数分析 Download PDFInfo
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Abstract
本发明涉及对可植入限制装置和数据记录器的生理参数分析。可植入限制装置可在患者体内提供限制。可植入限制装置可包括用于感测多种参数的一个或多个传感器,该参数诸如限制装置内的流体压力、脉冲宽度、脉冲幅值、脉冲计数、脉冲持续时间、频率、电特性、或其他参数。由传感器获得的数据可通过使用遥测线圈或其他通信装置被传递到患者体外的装置诸如数据记录器。数据记录器可存储数据并通过网络将数据传递到远程位置。可提供对接站来将数据记录器耦合到网络和/或给数据记录器的电池充电。记录的数据使用多种技术被分析和/或显示,以评估和/或跟踪限制装置的状况或患者的状况,以便监测患者生理状况或用于其他目的。
Description
相关申请的交叉应用
本申请是2006年4月6日提交的系列号为No.11/398,940、题为“Monitoring of a Food Intake Restriction Device”的美国专利申请(现在公开为US2006/0199997)的部分继续申请,该申请的教导通过引用整体结合在本文中。
技术领域
本发明的实施方式总的涉及一种可植入的限制性打开装置,更具体地,涉及一种用于监测与可植入的食物摄入限制装置相关的生理参数的通信系统。
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开口。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入限制部分或者人造开口。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,胃中的人造开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开口的尺寸。另外,需要改变人造开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,透视法很昂贵并且存在承受辐射量的问题。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开口。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在组织壁上的过大的压力而导致胃组织的侵蚀时才被揭示。
另外,在过去,对胃束带的长期性能和/或患者进行跟踪或监测是困难的,但这具有很广泛的益处。例如,获得和显示在一段时间来自胃束带或与胃束带相关的数据(实时数据)可以用于调节、诊断、监测或其他目的。可以进一步有利地存储这种数据,对数据进行处理以获得其它类型的有意义的数据和/或将所述数据与远程位置进行通信。允许医生或患者操纵或跟踪这种信息可以增加新的尺寸,以治疗肥胖或进行其它形式的治疗。前述的例子仅仅是示例性的而非限制性的。虽然已经利用各种技术和装置治疗肥胖,但相信没有人早于本发明人提出或利用如所附权利要求书中所限定的本发明。
因此,提供了用于可植入的胃限制装置的方法和装置,特别是用于记录、显示、分析和/或处理来自可植入的限制装置或与可植入的限制装置相关的数据。
发明内容
在一个方面,提供了一种用于显示来自可植入的限制装置或与其相关的信息的生理监测装置的屏幕显示。例如,一种示例性的屏幕显示可以包括由可植入的限制装置,例如可调节的胃束带包围的区域的布置的模拟图形,该模拟图形通过区域指示布置的尺寸。所指示的尺寸可以至少部分地基于由可植入的限制装置感测参数和传递到生理监测装置的参数。在这里描述的该实施方式和其它实施方式中,所感测参数可以包括多种参数,例如压力、脉冲计数、脉冲宽度、脉冲持续时间、脉冲幅度、脉冲频率、所感测的电子特征等。在一些实施方式中,模拟图形可以包括一个或多个在所包围的区域的图形表示上显示的等量线,等量线表示所感测参数值,使得在该区域中布置的参数指示所感测参数。等量线可以改变颜色以标示与所感测参数值相关的情况。在其它实施方式中,模拟图形可以包括人造开口的横截面的图像、围绕解剖腔设置的限制装置的图像、丸剂、图标、标记的图像,和/或三维图像。模拟图形也可以包括影像图形,用于示出在一段时间内根据由可植入的限制装置所感测压力(或其它参数)的开口尺寸中的变化。模拟图形还可以基于从患者身体获得的图像,其中,可植入的限制装置被植入患者体内。屏幕显示还可以包括对所感测参数、示出在图形或标度盘指示器上的所感测参数数据、和/或可植入的限制装置的限制状态的指示的文本指示器。
在另一个方面中,一种示例性的屏幕显示可以包括所感测参数随着时间的图形,该图形包括由可植入的限制装置,例如可调节的胃束带所感测的数据表示参数值的图形表示,并且传递到生理监测装置。该屏幕显示还可以包括一个或多个设置在图形表示上的注释标记,以指示在选择的时间注释的存在,一个或多个注释标记每个与描述,例如文本或图像相关联。相关联的描述可以包括例如医疗事件的描述、生理状态的描述、症状的描述、患者的意见、和/或医生的意见。图形表示可以包括曲线描绘的所感测压力值。屏幕显示还可以包括一列预定的注释事件,从所述事件用户可以选择描述。
在另一方面中,一种示例性的屏幕显示可以包括参数/容积数据集(例如,参数数据集、例如压力、脉冲计数、脉冲宽度、脉冲幅度、脉冲频率等)、对应于患者体内的可植入的限制装置,例如可调节的胃束带并且包括一个或多个相关量(a)用于可植入的限制装置的填充容积与(b)由可植入的限制装置在填充容积处所感测的并且传递到生理监测装置的参数的每个参数/容积数据集的多个图形表示。多个图形表示中的一个可以表示用于当前患者的压力/容积数据集,图形表示的另一个可以表示用于另一位患者的参数/容积数据集。
在一些实施方式中,参数/容积数据集的多个图形表示的一种表示当前患者,多个图形表示的剩余图形表示代表用于患者群的参数/容积数据集。图形表示例如可以是图示在参数和填充容积的图形上的曲线。图形表示也可以包括显示在参数和填充容积的图形上的曲线,并且其中多个图形表示中的一个表示用于当前患者的参数/容积数据集,另一个图形表示代表用于患者群的平均参数/容积数据集,该平均参数/容积数据集包括一个或多个相关量(a)填充容积和(b)由可植入的限制装置在填充容积处通过患者群所感测参数(例如压力)平均值。屏幕显示还可以包括上界趋势线和下界趋势线,并且限定围绕图示平均参数/容积数据集的线。
还可以提供一种用于监测可植入的限制装置的方法,在一种实施方式中,该方法可以包括提供多个参数/容积数据集,每个对应于患者体内的可植入的限制装置并且包括一个或多个相关量(a)用于可植入的限制装置的填充容积与(b)由可植入的限制装置在填充容积处所感测的并且传递到外部装置的参数。该方法还可以包括显示对应于所选择的可植入的限制装置的所选择的参数/容积数据集的图形表示以及对应于一个或多个其它可植入的限制装置的一个或多个其它参数/容积数据集的一个或多个其它图形表示。该方法还可以包括计算一个或多个其它参数/容积数据集的每个容积的平均压力值以形成平均的参数/容积数据集,并且显示平均参数/容积数据集的图形表示。
在又一个方面中,一种示例性的屏幕显示可以包括具有参数轴和脉冲计数轴的图形,用于使由可植入的限制装置,例如可调节的胃束带所感测参数与脉冲计数相关。脉冲计数可以表示在吞咽事件中在脉冲序列中的所感测参数的脉冲的序列数。该屏幕显示还可以包括在参数和脉冲计数交会处设置在图形上的多个离散的指示器,其中每个离散的指示器表示预定的参数幅值并且多个离散的指示器由此表示在脉冲序列中用于每个脉冲所测量的总的参数幅值。在一些实施方式中,时间印模可以在脉冲序列中的至少一个脉冲时显示。时间印模可以指示脉冲发生的时间、脉冲持续时间、脉冲间隔时间或其它测量值。
在又一个方面中,一种示例性的屏幕显示可以包括参数和时间的图形,参数(例如如前所述的压力、或任何其它参数)由可植入的限制装置所感测,图形表示指示在第一时间间隔中与由可植入的限制装置,例如可调节的胃束带所感测参数相关的值,并且图形表示指示在第二和随后的时间间隔中与由可植入的限制装置所感测参数相关的值。在一些实施方式中,用于第一时间间隔的图形表示至少部分地覆盖用于第二时间间隔的图形表示。第一时间间隔可以早于医疗动作,第二和随后的时间间隔可以晚于医疗动作,并且医疗动作可以是对可植入的限制装置的调节。在一些实施方式中,用于第一时间间隔和用于第二和随后的时间间隔的图形表示包括显示在具有一个或多个在其中的参数脉冲的图形上的曲线。用于第一时间间隔和第二时间间隔的图形表示能够是重叠的,使得在用于第一时间间隔的图形表示中的至少一个参数脉冲与用于第二时间间隔的图形表示中的至少一个参数脉冲重叠。
在又一个方面中,一种示例性的屏幕显示可以包括显示所感测压力的压力屏幕,所感测压力由可植入的限制装置(例如可调节的胃束带)所感测并且传递到生理监测装置,并且脉冲计数屏幕显示指示在吞咽过程中发生的所感测压力中的脉冲计数量,和/或压力屏幕显示具有用于所感测压力的指示器,所述指示器落入对应于可植入的限制装置的情况的多个压力范围中的一个内。压力屏幕显示例如可以包括显示压力随着时间的图形,其中,所感测压力由标出的曲线表示,线性仪表包括多个离散的指示器,其中,每个离散的指示器对应于预定的所感测压力,指示器适于改变颜色以指示情况、圆形压力计、和/或文本指示器。压力范围可以对应于用于填充流体的可植入的限制装置的情况,包括“过度填充”、“最优”和“未充满”。在一些实施方式中,图形、线性仪表、圆形压力计和/或文本指示器能够被构造成提供关于视觉警报或报警情况的信号。在其它实施方式中,听觉警报能够被构造成在图形、线性仪表、圆形压力计和文本指示器中的任何一个指示值在阈值以上时激活。
在又一个方面中,一种示例性的方法可以包括获得具有前述屏幕显示或特征的任何一种的生理监测装置,并且重新设定生理监测装置和/或屏幕显示的目标。重新设定目标可以包括例如重新构造装置或屏幕显示,修改、重新编程、擦除或定制装置或屏幕显示。重新设定目标还包括修复、重调节或灭菌装置或屏幕显示。
可以多种方式使用、处理和/或分析从植入的装置获得的数据。例如,获得关于生理参数的信息的一种示例性的方法可以包括在一段时间内从可植入的限制装置收集数据,所收集的数据包含关于在一段时间内在体内感测参数(例如压力)的值的信息,并且在该时间间隔的至少一部分中分析数据处理装置中的数据以确定关于生理参数(例如心率、呼吸频率、由蠕动事件引起的脉搏速率、基线参数等)的信息。所确定的信息可以包括例如频率、值、幅值、在时间间隔的至少一部分中值的改变、和在一段时间内的平均值。在一种实施方式中,该方法可以包括在时间间隔内确定所感测参数的值中的频率量变化,并将频率量中的一个或多个频率识别为生理参数的频率。该方法还可以包括将一个或多个频率(或它们的平均值)与一个或多个预定的频率进行比较,预定的频率被指定为与生理参数相关的频率。在一些实施方式中,该方法可以包括在时间间隔的至少一部分中确定压力值中的频率量变化,选择一个或多个出现在频率量中的频率,所述频率落入被指定为生理事件(例如心率、呼吸速率等)的可能速率的频率的预定范围内,并且基于一个或多个所选择的频率标识用于生理事件的速率。确定频率量还可以通过进行傅里叶分析来完成。在其它实施方式中,该方法可以包括在时间间隔的至少一部分中计算显示在压力值改变中的频率,并且将该频率与被指定为生理事件的可能速率的频率的预定范围进行对比以确定该频率是否落入频率范围中。计算频率可以通过例如记录至少两次,在所述至少两次记录时压力值是局部极大值或极小值;并基于至少两次之间的差计算频率来完成。该方法还可以包括确定在计算的频率下压力值变化的幅值,并且将幅值与被指定为可能的生理事件幅值的预定范围进行对比,以确定幅值是否落入范围内。在其它实施方式中,该方法可以包括计算(i)在一段时间内某时刻的压力值,和(ii)在该时刻的压力平均值之间的差值,其中,该差值表示对应于生理参数的值。平均值可以例如基于落入时窗中的值来计算。此外,生理事件或速率的确定可以引起警报或能够导致数据处理装置产生报告。
在另一个方面中,用于分析来自可植入的限制装置的数据以确定用于生理参数的基线值的一种示例性方法可以包括在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在一段时间内体内所感测参数值的信息。该方法还可以包括限定值的范围以表示公差范围,并且将在一段时间内所感测参数的一个或多个值与公差范围进行比较以确定一个或多个值中的所有值是否都落入公差范围内,如果是,那么基线被识别为已建立。值的范围可以通过各种方式来限定,包括关于运行平均值,或者通过设定超过运行平均值的上限制和低于运行平均值的下限值。该方法还可以包括在时间间隔内的平均窗过程中基于所感测参数值计算运行平均值;并且将运行平均值识别为基线值。在一些实施方式中,该方法还可以包括在时间间隔内的平均窗过程中基于所感测参数值计算运行平均值;并且将运行平均值识别为基线值。在其它实施方式中,该方法可以包括在发生事件时产生报警或报告,例如(i)识别基线值;(ii)未识别临界时间内的基线值;和(iii)识别基线值并且基线值通过阈值。在一些实施方式中,流体可以被添加到可植入的限制装置或从可植入的限制装置移出,和/或所确定的基线值可以与可植入的限制装置的状态相关,该状态可以是最优地填满、过度填充或未充满(或者最优地张紧、过紧和松弛)中的一种。
在另一个方面中,可以提供用于分析来自可植入的限制装置的数据以确定关于生理参数的基线的信息的一种示例性的方法。该方法可以包括在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在该时间间隔内在体内所感测参数值的信息。该方法还可以包括至少部分地基于在一段时间内所感测参数的一个或多个值计算预定的时间量,直到生理参数的值的变化率大约为零。在一些实施方式中,计算预定的时间量可以包括至少部分地基于变化率和变化率的变化率计算在一段时间内窗的所感测参数的值的变化率,计算窗的所感测参数的值的变化率的变化率,和计算预定的时间量,直到所感测参数值的变化率大约为零。在一些实施方式中,预定的基线值例如可以通过从窗内的一个或多个值外推到所感测参数的预定基线值,并且通过使一段时间内的用于窗的所感测参数值的变化率与预定时间量相乘来计算。在一些实施方式中,如果变化率超过阈值,那么可以产生警报或报告。此外,变化率可以与可植入的限制装置的状态相关,该状态可以是最优地填满、过度填充或未充满(或者最优地张紧、过紧和松弛)中的一种。
在另一个方面中,可以提供一种用于分析来自可植入的限制装置的数据以识别是否存在脉冲的示例性的方法。该方法可以包括在一段时间内从可植入的限制装置收集数据,所收集的数据包含关于在一段时间内在体内所感测参数值的信息,识别所感测参数值中的脉冲是否存在。识别可以包括找到所感测参数的一个或多个值超过第一阈值,并且找到所感测得参数的一个或多个随后的值落在第一阈值或第二阈值之后(这种阈值可以相对于用于参数的基线值来确定,和/或可以是不同的或相同的值)。在一些实施方式中,识别还可以包括找到所感测参数的一个或多个随后的值落在时窗中的第二阈值之后,时窗在时间间隔内并且在与超过第一阈值的一个或多个值相关的时间点开始。用于分析来自可植入限制装置的数据以确定脉冲的存在的另一种示例性的方法可以包括在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在一段时间内在体内所感测得参数值的信息,并且识别所感测参数的值中的脉冲的存在。识别可以包括找到一个或多个超过第一阈值的所感测参数值,找到后接减小值的一个或多个随后的所参测的参数值,一个或多个随后的值表示峰值;并且找到落在时窗中的第二临界点之后的所感测参数的一个或多个其它随后的值。时窗可以在时间间隔内,在实际上任何时间开始,例如在峰值出现等时。在一些实施方式中,在预定时间间隔内在识别脉冲或如果脉冲计数超过阈值时,可以产生警报或报告。此外,这种信息可以与可植入的限制装置的状态相关,该状态可以是最优地填满、过度填充或未充满(或者最优地张紧、过紧和松弛)中的一种。
在另一个方面中,可以提供一种用于分析来自可植入的限制装置的数据以检测生理状态或与可植入的限制装置相关的状态的存在的示例性的方法。该方法可以包括在时间间隔内从可植入的限制装置收集数据,所收集的数据包含关于在时间间隔内在体内感测参数值的信息,找到对应于在压力和时间曲线下的区域的一个或多个区域,并且将所述区域进行比较,比较的结果与状态相关。在一些实施方式中,找到一个或多个区域可以包括对于一个或多个区域中的每一个基于在时间间隔内在每个窗上所感测参数值计算积分(在一些实施方式中包括数值积分),积分的计算产生表示在压力和时间曲线下的面积(在一个或多个脉冲下的面积)的结果。该方法还可以包括使在第一预定速率下出现的面积的下降序列与最优地填充的可植入的限制装置相关联;使与过度填充的可植入的限制装置基本上相等的面积序列相关联;和/或能够包括使在第二预定速率下出现的面积的下降序列与未充满的可植入的限制装置相关联。
在另一个方面中,可以提供一种分析来自可植入的限制装置的数据以去除数据中的噪音的示例性的方法。这种方法可以包括在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在时间间隔内在体内感测参数值的信息,并且调节所感测参数值用于显示或进一步分析。调节能够包括过滤和/或将来自第一采样率的所感测参数转换成第二和较低的采样率,和/或可以包括计算所感测参数的开方均方值或对所感测参数进行回归分析。在一些实施方式中,调节可以包括基于一组周围的所感测参数值在时间间隔内计算每一次的所感测参数的平均值。在其它实施方式中,调节可以包括将时间间隔的至少一部分分割成预定尺寸的多个平均窗;并且在每个平均窗中计算所感测参数的平均值。调节的值能够存储为被压缩的信息。
在另一个方面中,一种用于分析来自可植入的限制装置的数据的示例性的方法可以包括在一段时间内从可植入的限制装置收集数据,所收集的数据包含关于在一定时间内在体内感测参数值的信息。该方法还可以包括在一段时间内计算时间X的生理参数的平均值,平均值基于在一段时间内在平均窗中所感测的一个或多个参数值来计算。在一些实施方式中,平均窗(i)可以先于时间X,或者(ii)可以围绕时间X。该方法还可以包括在所感测参数与时间的图形上显示平均值。
在又一个方面中,一种示例性的方法可以包括获得如在前述任一种实施方式中描述的用于处理数据的数据处理装置,并且重新设定该装置的用途。重新设定用途可以包括例如重新构造装置、修改、重新编程、擦除或定制装置硬件/软件。重新设定用途也包括修复、调节或灭菌装置。
通过以下经由图示的描述和用于执行本发明所设想的最优实施方式中的任一种,本发明的其他实施例、特征、方面、实施方式和优点对于本领域普通技术人员而言是明显的。如将被认识到的,本发明能够具有其他不同且明显的方面,所有均不脱离本发明。因此,附图和说明书应当被认为是示例性的而非限制性的。
本发明具体地涉及下面的内容:
(1).一种获得关于生理参数的信息的方法,包括:
在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在所述一段时间内在人体内所感测的参数值的信息;并且
在数据处理装置中,分析所述所收集的数据以确定所述一段时间的至少一部分的关于生理参数的信息。
(2).根据第(1)项所述的方法,其中,来自人体内的所感测的参数通过所述可植入的限制装置压力感测。
(3).根据第(1)项所述的方法,其中,所述生理参数是下述中的至少一种:心率、呼吸速率、蠕动事件发生率、蠕动事件速率和基线参数值。
(4).根据第(1)项所述的方法,其中,关于所述生理参数的所确定的信息是以下中的至少一项:频率、值、幅值、在所述一段时间内的至少一部分中值的改变,和在所述一段时间中的平均值。
(5).根据第(1)项所述的方法,还包括利用所收集的数据来确定在所述一段时间内的至少一部分中关于第二生理参数的信息。
(6).根据第(2)项所述的方法,还包括:
确定在所述一段时间内所述所感测的参数值中变化的频率量,并且将频率量中的一个或多个频率识别为所述生理参数的频率。
(7).根据第(6)项所述的方法,其中,识别一个或多个频率包括将一个或多个频率与被指定为与所述生理参数相关的频率的一个或多个预定频率进行比较。
(8).根据第(2)项所述的方法,其中,所述生理参数是生理事件的速率,并且使用所述所收集的数据包括:
确定在所述一段时间的至少一部分中压力值中变化的频率量;
选择在频率量中存在的一个或多个频率,其落入被指定为生理事件的可能速率的频率的预定范围内;并且
基于所述一个或多个所选择的频率识别所述生理事件的速率。
(9).根据第(8)项所述的方法,其中,识别包括至少以下步骤中的一个:
(i)对所述一个或多个所选择的频率进行平均;并且
(ii)将所述一个或多个频率中的一个指定为所述速率。
(10).根据第(8)项所述的方法,其中,确定所述频率量包括对所述所收集的数据的至少一部分进行傅里叶变换。
(11).根据第(8)项所述的方法,其中,所述生理事件是心跳和表示心率的速率。
(12).根据第(8)项所述的方法,其中,所述生理事件是呼吸和表示呼吸速率的速率。
(13).根据第(8)项所述的方法,还包括如果所述速率超过临界速率产生警报或报告。
(14).根据第(2)项所述的方法,其中,所述生理参数是生理事件的速率,并且利用所述所收集的数据包括:
计算在所述一段时间的至少一部分中压力值中的频率变化;并且
将该频率与被指定为所述生理事件的可能速率的频率的预定范围进行对比,以确定频率是否落入所述范围内。
(15).根据第(14)项所述的方法,其中,计算所述频率包括:
记录至少两次,在所述两次记录时压力值是本地最大或最小值;并且
基于所述至少两次之间的差计算所述频率。
(16).根据第(14)项所述的方法,还包括:
确定在计算的频率下压力值中的变化幅值;并且
将所述幅值与被指定为可能的生理事件幅值的预定范围进行对比,以确定所述幅值是否落入所述范围内。
(17).根据第(14)项所述的方法,其中,所述生理事件是心跳并且所述速率表示心率。
(18).根据第(14)项所述的方法,其中,所述生理事件是呼吸并且所述速率表示呼吸速率。
(19).根据第(14)项所述的方法,还包括如果所述速率超过临界速率产生警报或报告。
(20).根据第(2)项所述的方法,其中,利用所述所收集的数据包括:
计算在(i)所述一段时间内的时间点处的压力值和(ii)在该时间点处的平均压力值之间的差,其中,所述差表示对应于所述生理参数的值。
(21).根据第(20)项所述的方法,其中,所述生理参数是下列中的至少一个:心率和呼吸速率。
(22).根据第(20)项所述的方法,其中,所述平均值基于围绕在所述时间点处的值的平均窗中的一组值计算。
(23).一种分析来自可植入的限制装置的数据以确定用于生理参数的基线值的方法,包括:
在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在一段时间内人体内所感测的参数值的信息;
在数据处理装置中,
限定值的范围以表示公差范围;并且
将在一段时间内所感测的参数的一个或多个值与公差范围进行比较以确定一个或多个值中的所有值是否都落入公差范围内,如果是,那么基线被识别为已建立。
(24).根据第(23)项所述的方法,还包括在一段时间内的平均窗过程中基于所感测的参数值计算运行平均值;并且
将运行平均值识别为基线值。
(25).根据第(23)项所述的方法,还包括在发生事件时产生警报或报告,所述事件包括以下中的至少一项:
(i)识别基线值;
(ii)未识别临界时间内的基线值;和
(iii)识别基线值并且基线值超过临界值。
(26).根据第(23)项所述的方法,其中,值的范围相对于运行平均值限定。
(27).根据第(23)项所述的方法,其中,值的范围由超过运行平均值的上限值和低于运行平均值的下限值限定。
(28).根据第(23)项所述的方法,其中,所感测的参数由所述可植入的限制装置压力感测。
(29).根据第(23)项所述的方法,其中,所述可植入的限制装置是可填充流体的,并且还包括使确定的基线值与可植入的限制装置的状态相关,该状态是最佳地填满、过满或未满中的一种。
(30).根据第(23)项所述的方法,还包括向可植入的限制装置添加流体或从可植入的限制装置移出流体。
(31).一种用于分析来自可植入的限制装置的数据以确定关于生理参数的基线的信息的方法,包括:
在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在一段时间内人体内所感测的参数值的信息;并且
至少部分地基于在一段时间内所感测的参数的一个或多个值计算预定的时间量,直到生理参数的值的变化率大约为零,在变化率大约为零时生理参数的值表示基线值。
(32).根据第(31)项所述的方法,其中,所感测的参数通过可植入的限制装置压力感测。
(33).根据第(31)项所述的方法,其中,计算预定时间量包括:
计算一段时间内的用于窗口的所感测的参数值的变化率;
计算所述变化率变化的速率;并且
至少部分地基于变化率和该变化率变化的速率计算预定的时间量,直到所感测的参数值的变化率大约为零。
(34).根据第(33)项所述的方法,其中,计算预定的时间量还包括:
用所述变化率变化的速率除所述变化率并且乘以一段窗口以获得预定的时间量,直到所感测的参数具有大约为零的变化率。
(35).根据第(33)项所述的方法,还包括:
至少部分地基于在一段时间内和预定的时间量所感测的参数值计算在变化率大约为零时所感测的参数的预定基线值。
(36).根据第(35)项所述的方法,其中,计算所述预定的基线值包括:
至少通过将一段时间内的用于窗口的所感测的参数的值的变化率与预定的时间量相乘直到所感测的参数值的变化率大约为零,从窗口内的一个或多个值外推到所感测的参数的预定基线值。
(37).根据第(31)项所述的方法,还包括如果变化率超过临界值时产生警报或报告。
(38).根据第(31)项所述的方法,其中,所述可植入的限制装置是可填充流体的,并且还包括使变化率与可植入的限制装置的状态相关,该状态是最佳地填满、过满或未满中的一种。
附图说明
虽然说明书后附了具体指出和明确要求保护本发明的权利要求,但是相信通过下面结合附图对一些实施例所作的描述将会更清楚地理解本发明,附图中相同的附图标记表示相同的元件,并且其中:
图1是植入式限制打开装置和在植入式限制打开装置和远程监测单元之间的双向通信系统的简化示意图;
图2是用于图1中食物摄入限制装置的可植入部分的更详细的透视图;
图3是图2中显示的注射端口的侧面部分横截面图;
图4是沿着图3中的线A-A所截取的侧面横截面图,其中示出了用于测量图2中的摄入限制装置中的流体压力的一种示例性的压力传感器;
图5是图4中的压力传感器的变阻电路的简化示意图;
图6是用于图2中的食物摄入限制装置的一种替代的双向注入器的横截面图;
图7A是并入压力传感器的可机械调节的限制装置的示意图;
图7B是沿着图7A中的线B-B截取的可机械调节的装置的横截面图;
图8是显示图1的摄入限制装置的内部和外部主要元件的框图;
图9是示出图1中在本地单元和远程单元之间的大量不同的通信线路的示意图;
图10是用于可手动调节的限制装置的在本地单元和远程单元之间的一种示例性的通信协议的流程图;
图11是用于可远程调节的限制装置的在本地单元和远程单元之间的一种示例性的通信协议的流程图;
图12是通信由患者启动的一种示例性的通信协议的流程图;
图13是用于记录有关植入式限制装置的压力测量值的数据记录器的简化示意图;
图14是显示出图13的数据记录器的主要元件的框图;
图15是表示通过本发明的系统通信的图4中的传感器的流体压力测量值的图式;
图16是用于记录有关图1的食物摄入限制装置的压力测量值的数据记录系统的简化示意图;
图17是显示图16的数据记录系统的若干元件的框图;
图18是显示图16中的具有多条不同通信线路且处于对接状态的数据记录系统;
图19A示出用于图形用户界面的一种示例性的压力图形屏幕显示;
图19B示出用于图形用户界面的一种示例性的压力计屏幕显示;
图19C示出用于图形用户界面的一种示例性的脉冲计数屏幕显示;
图20示出用于图形用户界面的另一种示例性的压力图形显示;
图21示出用于图形用户界面的另一种示例性的压力计屏幕显示;
图22示出用于图形用户界面的又一种示例性的压力计屏幕显示;
图23A示出用于图形用户界面的另一种示例性的脉冲计数屏幕显示;
图23B示出在双脉冲程序过程中图23A中的脉冲计数屏幕显示;
图24A示出由限制装置包围的人造开口的一种示例性屏幕显示;
图24B示出在由限制装置感测压力变化之后图24A中的屏幕显示;
图24C示出在由限制装置感测压力另一种变化之后图24A的屏幕显示;
图25示出能够与图24A-C中的显示相关的随着时间的一种示例性的压力图形;
图26A示出植入式限制装置的一种示例性的屏幕显示;
图26B示出在由限制装置感测压力变化之后图26A的屏幕显示;
图26C示出在由限制装置感测压力另一种变化之后图26A的屏幕显示;
图27A示出植入式限制装置的另一种示例性的屏幕显示;
图27B示出压力变化之后图27A中的屏幕显示;
图28示出植入式限制装置的又一种示例性的屏幕显示;
图29示出一组数据重叠另一组数据的一种示例性的屏幕显示;
图30示出一组数据重叠另一组数据的另一种示例性的屏幕显示;
图31A示出与限制装置相关的人群数据的一种示例性图形;
图31B示出与限制装置相关的人群数据的另一种示例性图形;
图32示出具有显示附有说明的数据值的屏幕显示和注释事件菜单;
图33示出具有显示数据值的屏幕的显示装置,其中数据值能够经由通过输入装置进入文本箱中的文本提供注释;
图34示出具有另一种示例性的数据值屏幕的图33中的显示装置;
图35A示出随着时间以100Hz的数据速率从限制装置收集的压力值的一种示例性图表;
图35B示出随着时间以被转换成10Hz的数据速率从图35A的压力值的一种示例性图表;
图35C示出随着时间以被转换成5Hz的数据速率从图35A的压力值的一种示例性图表;
图35D示出随着时间以被转换成3Hz的数据速率从图35A的压力值的一种示例性图表;
图35E示出随着时间以被转换成1Hz的数据速率从图35A的压力值的一种示例性图表;
图35F是用于将从限制装置收集的数据转换成其它数据速率的一种示例性的流程图;
图36A是随着时间从限制装置收集的压力值的一种示例性的图表,并且重叠有根据第一种技术从压力值计算的运行平均值的图表;
图36B是随着时间从限制装置收集的压力值的一种示例性的图表,并且重叠有根据第二种技术从压力值计算的运行平均值的图表;
图36C是用于计算从限制装置收集的数据运行平均值的一种示例性的流程图;
图37A是随着时间从限制装置收集的压力值的一种示例性的图表,该图表具有与计算基线值相关的注释;
图37B是用于确定从限制装置收集的数据的参数的基线值的一种示例性流程图;
图37C是显示基线值变化的随着时间的压力值的一种示例性的图表;
图38A是从限制装置收集的随着时间的压力值的一种示例性图表,该图表具有与描述基线值的特征相关的注释;
图38B是用于描述与从限制装置收集的数据的参数的基线值相关的特征的一种示例性的流程图;
图39A是从限制装置收集的随着时间的压力值的一种示例性图表,该图表显示不同频率的叠加脉冲;
图39B是从限制装置收集的随着时间的压力值的另一种示例性图表,该图表显示不同频率的叠加脉冲;
图39C是用于确定关于从限制装置收集的数据的生理参数的信息的一种示例性流程图;
图39D是用于确定关于从限制装置收集的数据的生理参数的信息的另一种示例性流程图;
图40A是从限制装置收集的随着时间的压力值的一种示例性图表,该图表具有关于从压力值提取的生理参数的信息;
图40B是从限制装置收集的随着时间的压力值和与其重叠的平均值的一种示例性图表;
图40C是从图40B中的数据提取的随着时间的压力值的一种示例性图表;
图40D是用于确定从限制装置收集的数据的生理参数的一种示例性的流程图;
图41A是从限制装置收集的随着时间的压力值的一种示例性图表,该图表显示不同频率的叠加脉冲;
图41B是图41A中所示图表的远侧视图;
图41C是图41A中所示图表的另一种远侧视图;
图42A是从限制装置收集的随着时间的压力值的一种示例性图表,该图表具有与确定脉冲存在相关的注释;
图42B是用于确定从限制装置收集的数据中的脉冲存在的一种示例性的流程图;
图43A是从限制装置收集的随着时间的压力值的另一种示例性的图表,该图表具有与经由另一种技术确定脉冲存在相关的注释;
图43B是经由图43A中描述的技术用于确定从限制装置收集的数据中脉冲存在的另一种示例性的流程图;
图44A是从限制装置收集的随着时间的压力值的又一种示例性的图表,该图表具有与经由又一种技术确定脉冲存在相关的注释;
图44B是经由图44A中描述的技术用于确定从限制装置收集的数据中的脉冲存在的又一种示例性的流程图;
图45A是从限制装置收集的随着时间的压力值的另一种示例性的图表,该图表具有与对比脉冲区域相关的注释;以及
图45B是用于利用从限制装置收集的数据对比脉冲区域的一种示例性的流程图。
具体实施方式
下面对本发明一些实施例的描述不应当用于限制本发明的范围。对于本领域技术人员来说,本发明的其他实施例、特征、方面、实施方式以及优点将通过下面的描述变得显而易见,下面的描述是说明性的,是考虑用于实施本发明的最佳方式中的一种。将会了解,本发明可以是其他不同的和明显的方面,所有这些都不背离本发明。因此,附图和说明书在本质上应当被认为是说明性的而非限制性的。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。
现在具体参照附图,在附图中相同的附图标记指示相同的元件,图1是用于在植入式限制性打开装置和位于远距离的监测单元之间传递数据的双向通信系统20的简化示意图。数据和指令信号可以通过通信系统20在植入式装置和位于远距离的医生之间传递,用于监测和影响患者治疗。本发明的通信系统能够使医生控制限制性打开装置和监测器来治疗,而不需与患者面对面进行治疗。出于本发明的目的,术语“远程”和“位于远距离”被限定为位于大于6英尺的距离处。在图1和以下说明中,限制性打开装置被示出并描述为用于肥胖治疗的食物摄入限制装置22。但是,食物摄入限制装置的使用仅仅是代表性的,并且本发明可以利用其它类型的植入式限制性打开装置而不脱离本发明的范围。另外,应当理解的是,限制装置22可以是(或者包括)任何种类的限制性装置,例如可填充流体的限制装置、基于机械的限制装置等。
如图1所示,摄入限制装置22的第一部分24被植入到患者皮肤27下面,而第二部分26位于患者皮肤外部。被植入的部分24包括围绕胃肠道植入的可调节的限制束带28,用于治疗病态肥胖症。在该应用中,可调节的束带28围绕胃30的外壁成环形,以在胃的上囊32和下囊34之间形成人造口。可调节的束带28可以包括由硅橡胶、或另外类型的生物相容性材料制成的腔,该腔在填充有流体时抵靠人造口30向内膨胀。替代地,束带28可以包括可机械调节的装置或可液压/机械结合调节的束带,该可机械调节的装置具有流体腔,该流体腔随着带调节而改变压力。
注射端口36(将在下文中更加详细地描述)被植入到针注射和遥感通信信号可达到的身体区域中。在所示实施方式中,注射端口36经由导管40与可调节的束带28流体连通。外科医生可以将注射端口36放置到并永久植入到患者体内,以对食物摄入限制或人造口进行调节。注射端口36通常植入在患者腹部脂肪组织的皮肤和脂肪组织层下面的侧肋下区域中。替代地,外科医生可以将注射端口36植入在患者的胸骨上。
图2更详细地示出了可调节的束带28。在此实施方式中,束带28包括可变容积腔42,该腔42抵靠着胃的外壁膨胀或收缩以形成可调节的人造口,用于可控地限制食物摄入胃中。医师可以通过向可变容积腔42中增加流体来减小胃人造口的尺寸,或者作为替代,可以通过从腔中取出流体来增加胃人造口的尺寸。流体可以通过将针插入到注射端口36中来增加或取出。流体可以是但不限于百分之0.9的生理盐水。
现在返回图1,摄入限制装置22的外部部分26包括(在本实施方式中经由电缆组件56)电连接到本地单元60的手持式天线54。电缆组件56可以可拆卸地连接到本地单元60或天线54,以便于外部部分26的清洁、维修、使用和贮存。本地单元60是与植入式装置22和远程单元170通信的微处理器控制的装置,如以下将要更加详细说明的。本地单元60通过天线54与被植入的注射端口36非侵入式地通信。天线54可以被保持抵靠在注射端口36的位置附近的患者皮肤上,以传递遥感和功率信号到注射端口36。
现在回到图3,其显示了一种示例性的注射端口36的侧向局部剖视图。如图3所示,注射端口36包括刚性外壳70,该外壳70具有环形凸缘72,该环形凸缘72含有多个连接孔74,用于将注射端口紧固到患者体内的组织上。外科医生可以使用包括缝线、钉子和夹子的多种外科紧固件中的任意一种将注射端口36连接到组织上,例如连接到覆盖腹肌的筋膜上。注射端口36还包括通常由硅橡胶制成并压缩地保持在外壳70中的隔膜76。隔膜76可以由Huber针或者类似类型的注射器械穿透,用于向注射端口中增加或者从注射端口中取出流体。隔膜76在取出注射器针时自动密封以保持注射端口36内的流体量。注射端口36还包括贮液池80,用于保持流体和导管接头82。接头82连接到导管40,如图2所示,以便在贮液池80与腔42之间形成封闭的液压回路。外壳70和接头82可以由生物相容性聚合物整体铸造成,或者由金属如钛或不锈钢构成。
注射端口36还包括用于测量装置内的流体压力的压力传感器84。由传感器84测量的压力对应于由束带28施加到患者的胃或其它体腔上的限制量。压力测量值使用天线54通过遥感信号从传感器84传递到本地单元60。本地单元60可以显示、打印和/或传递压力测量值到远程监测单元用于计算,如下文更加详细的说明。在图3所示的实施方式中,压力传感器84设置在外壳70内的贮液池80的底部。保持盖86在压力传感器84上方延伸,以基本上将传感器表面与贮液池80分离开,并保护传感器不被针穿入。保持盖86可以由陶瓷材料制造,例如氧化铝,其能够抵抗针的穿入并且不会干扰压力传感器84与天线54之间的电子通信。保持盖86包括出口90,允许贮液池80内的流体流向并冲击压力传感器84的表面。
图4是沿图3中的线A-A获取的压力传感器84的侧向剖视图,示出了用于测量流体压力的一种示例性的实施方式。压力传感器84被气密地密封在外壳94内,以防止流体渗透并影响传感器的操作。压力传感器84的外部包括具有可变形表面的膜片92。通过使钛贮液池80的底部的一部分变薄到厚度在0.001″到0.002″之间而形成膜片92。当流体流过贮液池80中的出口90时,流体冲击在膜片92的表面上,使得该表面机械地移位。膜片92的机械位移通过一对变阻器、硅应变计96、98转换成电信号。应变计96、98在与贮液池80中的工作流体相反的侧面连接到膜片92。应变计96连接到膜片92的中心部分,以测量膜片的位移。第二匹配应变计98连接到膜片92的外边缘附近。应变计96、98可以通过粘合剂连接到膜片92,或者可以熔接到膜片结构中。当束带28中的流体压力波动时,膜片92的表面在贮液池80的底部处向上或向下变形。膜片92的这种变形产生中心应变计96中的阻力变化。
如图5所示,应变计96、98形成惠斯通电桥电路100顶部的两个半补偿(half-compensated)电阻元件。当应变计96对膜片92的机械位移作出反应时,该应变计变化的电阻将改变电桥电路顶部的电势。应变计98与应变计96匹配,并使惠斯通电桥电路绝热。差分放大器102、104连接到电桥电路100,以测量电桥电路中由于变阻应变计导致的电势的变化。具体而言,差分放大器102测量整个电桥电路上的电压,差分放大器104则测量半个电桥电路100的应变计上的电压。对于固定电压的电桥来说,应变计电压之间的差值越大,压力差也就越大。如果需要,还可以使用全补偿惠斯通电桥电路以增加压力传感器84的灵敏度和准确度。在全补偿电桥电路中,四个应变计连接到膜片92的表面,而不是图4所示的仅仅两个应变计。
返回图4,来自差分放大器102、104的输出信号提供给微控制器106。微控制器106集成到外壳94内部的线路板110中。温度传感器112测量注射端口36内的温度并将温度信号输入给微控制器106。微控制器106使用来自传感器112的温度信号来补偿没有被应变计98所考虑的体温变化和残留温度误差。补偿体温变化的压力测量信号增加了压力传感器84的准确度。另外,TET/遥感线圈114放置在外壳94内。线圈114连接到电容器116以形成用于从本地单元60接收能量的调谐储能电路,该储能电路用于将包括测量的流体压力在内的生理数据传递给本地单元60。图3至5示出了用于测量摄入限制装置内的流体压力的一种示例性实施方式。用于测量流体压力的另外的实施方式公开在题为“Non-invasive Measurement of FluidPressure in a Bariatric Device”、序列号为No.11/065410的美国专利申请文献中(现在公布为美国专利公开No.2006/0189888),该文献的内容通过引用合并在此。
作为注射端口36的一种替代,被植入部分24可以包括用于改变可调节限制束带28中的流体水平的双向注入器。利用注入器,可以通过遥感指令信号添加流体或从束带28抽出流体,而不必使注射器通过患者的皮肤插入到端口隔膜内。图6是一种示例性的注入器115的剖视图。如图6所示,注入器115包括泵(总的用118指示),用于响应遥感指令信号非侵入地输送流体流入束带或流出束带。泵118被封闭在圆柱形外壳120内,该外壳120具有延伸经过顶部的环形盖121。可折叠波纹管122稳固地连接在盖121的顶部周边处。波纹管122由适当的材料,例如钛构成,该波纹管122在其褶皱处能够反复地弯曲,但其具有足够的刚性以便不受压力变化影响。波纹管122的下周边固定到环形波纹管帽123上,该波纹管帽123在泵118内竖直地移动。盖121、波纹管122和波纹管帽123的结合限定流体贮液池124的容积。导管接头119连接到导管40(如图2所示)以在束带和流体贮液池124之间形成封闭的液压回路。贮液器124中的容积可以通过波纹管帽123沿着向下的方向远离盖121运动而扩大。在波纹管帽123下行时,波纹管122的褶皱被拉伸,形成真空以拉动来自束带的流体通过导管40和接头119进入贮液池124中。类似地,贮液池124中的容积可以通过波纹管帽123沿着向上的方向朝着盖121运动而减小,由此压缩波纹管122的褶皱并迫使流体从贮液池,通过导管40和接头119进入束带28中。
波纹管帽123包括一体形成的导螺杆部分125,该导螺杆部分125可操作地接合圆柱形螺母126上的配合螺纹。螺母126的外圆周稳固地连接到旋转驱动板127的轴向孔。圆柱形驱动环128又围绕旋转驱动板127的外环形边缘安装。螺母126、驱动板127和驱动环128通过任何适当的部件稳固地连接在一起,以形成作为一个单元围绕由螺杆部分125形成的轴线旋转的组件。套筒框架129包围TET和遥感线圈(未示出),用于在天线54和泵118之间传递功率和数据信号。
驱动环128通过一个或多个压电谐波电动机旋转地驱动。在图6所示的实施方式中,两个谐波电动机131被设置成使得每个电动机的末端113与驱动环128的内圆周摩擦接触。当电动机131被供应能量时,末端113抵靠着驱动环128振动,产生沿着环的内圆周的“步行”运动,该运动使该环旋转。泵118中的微控制器(未示出)电连接到TET和遥感线圈,用于向驱动电动机131接收功率以及为泵接收并传递数据信号。为了改变束带腔42中的流体水平,通过遥感从天线54传递调节指示。注入器115中的遥感线圈检测并传递指示信号到微控制器。微控制器又在适当的程度上驱动电动机131,以使波纹管122塌缩或扩张并且驱动需要量的流体到束带28或来自束带28的流体。
为了测量注入器115内的压力变化,由此测量人造口的尺寸中的压力变化,由方框84′指示的压力传感器被包括在波纹管122内。压力传感器84′类似于上述的压力传感器84。当作用于束带28的压力由于例如来自吞咽的蠕动压力而改变时,束带28中的流体经受压力变化。这些压力变化通过导管40中的流体传回到波纹管122。压力传感器84′中的膜片响应波纹管122中的流体压力变化而偏转。膜片偏转以关于图4和5的上述方式被转化成指示所施加的压力的电信号。压力信号被输入到注入器微控制器,该注入器微控制器经由遥感线圈将压力传递到患者体外的监测单元。关于双向注入器115的操作的另外的细节可以在题为“Non-invasive Measurement of FluidPressure in a Bariatric Device”、序列号为No.11/065410的共同转让的、共同未决美国专利申请中找到,该美国专利申请的内容通过引用合并在此。
图7A和7B描述了用于在患者腹部中形成食物摄入限制的可机械调节的束带153。机械束带153可以用作对用于形成人造口的可液压调节的束带28的一种替代。可机械调节的束带153包括具有重叠的端部135、137的基本上圆形的弹性芯133。芯133基本上被包围在填充流体的柔顺外壳139中。芯133的可释放且可锁定的接合件149从外壳139的端部突出,以使芯和外壳能够围绕患者的食管或胃放置以形成人造口。被植入的电动机141与芯133被分隔开,以便机械地调节芯端部135、137的重叠程度以及由芯形成的人造口尺寸。电动机141通过连接到外壳139中的驱动轮(未示出)的驱动轴143调节芯133的尺寸。电动机141与由硅橡胶或另外的类似材料构成的主体147中的远程控制的功率供应单元145一起被模制。
随着电动机141改变芯133的尺寸,外壳139中的流体压力改变。为了测量压力改变,压力传感器(类似于上述的压力传感器)被布置成与外壳139的流体连通。压力传感器可以设置在外壳139内,如由框84″所示,使得人造口内的压力变化通过外壳139中的流体传输到传感器的膜片。传感器84″将膜片的偏转转换成压力测量信号,该压力测量信号以上述方式经由遥感传递到外部单元。在一种替代的情况下,压力传感器可以布置在被植入的电动机主体147内,如由框84″′所示,并且经由沿着驱动轴143延伸的管151流体连接到外壳139。当流体压力在外壳139内由于人造口中的压力改变而变化时,压力差通过管151中的流体传递到传感器84″′。传感器84″′产生指示流体压力的电信号。该信号以上述方式从患者传递到外部单元。
图8是摄入限制装置22的被植入部分24和外部部分26的主要元件的框图。如图8所示,外部部分26包括用于将功率信号132传递到被植入部分24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被植入部分24。初级TET线圈130和遥感线圈144组合形成如图所示的天线54。外部部分26的本地单元60包括用于控制对初级TET线圈130的功率施加的TET驱动电路134。TET驱动电路134由微处理器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、显示和/或打印数据和医生指令。通过用户界面140,患者或者临床医生可将调节要求传递给医生并且还输入该要求的提出原因。另外,用户界面140可使患者能够读取来自医生的指令并作出反应。
本地单元60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106并从微控制器106接收响应数据,响应数据包括感测到的流体压力。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被植入的微控制器106的下行交变磁场146。作为替代,收发器142可接收来自次级线圈114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可为本地单元60提供能量以便为摄入限制装置22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的信号以便针对大气压的变化(例如由于气压条件或者高度的变化)调节接收的流体压力测量值。
图8还示出了装置22的被植入部分24的主要元件。如图8中所示,次级TET/遥感线圈114接收来自外部天线54的功率和通信信号。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控制与线圈114的数据交换。另外,被植入部分24包括整流器/功率调节器160、上述的微控制器106、与微控制器相关联的存储器162、温度传感器112、压力传感器84和用于放大来自压力传感器的信号的信号调节电路164。被植入的元件可将温度调节的压力测量值从传感器84经天线54输送到本地单元60。压力测量值可被存储在本地单元60中的存储器138内,在本地单元60中的显示器上显示或实时传递到远程监测站。
如上所述,期望提供一种用于对摄入限制装置进行远程监测和控制的通信系统。通过通信系统,医生可以检索来自限制装置的流体压力测量值的历史记录,以计算肥胖治疗的效力。另外,医生可以下行链接指令用于装置调节。位于远距离的临床医生可以通过本地单元60接收到调节指令。利用所述指令,临床医生可以将注射器注射到注射端口36中并且添加生理盐水或从流体贮液池80中移除生理盐水,以完成装置调节。替代地,患者可以通过本地单元60访问指令,并且利用天线54非侵入地在注入器115或可机械调节的束带153中执行指令。实时压力测量结果可以在调节过程中上行传输到医生,以便对调节效果进行即时反馈。替代地,患者或临床医生可以在调节之后向医生上行传输压力测量结果,用于确认和评价该调节。
如图1所示,通信系统20包括本地单元60和远程监测单元170,该远程监测单元170在这里也被称为基本单元。远程单元170可以位于医生的办公室、医院或医务室等处。本实施例的远程单元170是包括微处理器172的个人电脑类型的装置,该微处理器172例如可以是Intel Pentiu m.RTM.微处理器或类似物等。替代地,远程单元170可以包括专用的或非专用的服务器,该服务器通过网络例如因特网可以访问。在本实施例中,系统总线171将微处理器172与存储器174互连,该存储器用于存储数据,例如生理参数和患者指令。图形用户界面176也互连到微处理器172,用于显示数据和输入指令并对应于患者。用户界面176可以包括图像监测器、接触式屏幕或其它显示装置,以及用于将信息输进远程单元170的键盘或触笔。本领域普通技术人员可以想到适用于提供远程单元170的其他装置和构造。
大量外围设备178可以直接与本地单元60连接,用于输入与患者状况相关的生理数据。该生理数据可以存储在本地单元60中并且在询问或其它数据交换过程中上载到远程单元170。能够为本发明所利用的外围设备的例子包括称量台、血压监护器、温度计、血液葡萄糖监护器,或者任何其它类型的可以在医生办公室外使用以提供与患者的当前生理状况相关的输入的装置。称量台例如能够通过天线54直接地或无线地与本地单元60电通信,以为患者生成重量减轻记录。重量减轻记录可以存储在本地单元60的存储器138中。在通过远程单元170或在预定间隔自动地随后询问的过程中,重量减轻记录能够由微处理器136上载到远程单元170。重量减轻记录可以存储在远程单元170的存储器174中,直到医生访问。
同样如图1所示,通信线路180在本地单元60和远程单元170之间形成,用于在单元之间传输数据,包括声音、图像、指示信息和指令信号。通信线路180可以包括任何广限的数据传输介质,包括利用高速电缆或拨号连接的基于网络的系统、公用电话线路、无线RF网络、卫星、T1线路或任何其它类型的适用于在远程位置之间传输数据的通信介质。图9更加详细地示出了用于通信线路180的各种介质。如图9所示,本地单元60和远程单元170可以通过大量不同的直接和无线连接通信。具体地,单元可以利用电缆或电话调制解调器192、194或任何其它适当的装置通过因特网190通信。在该情况下,数据可以通过任何适当的因特网通信媒介,例如电子邮件、即时消息、网页或文件传输等传输。替代地,本地单元60和远程单元170可以利用调制解调器200、202通过公用电话网络196连接。单元60、170也可以经由可调频率波206、210通过微波或RF天线204通信。通信线路也可以通过卫星209和可调频率波212、214建立。除了上述的线路之外,可以设想现有技术中已知的或可以在今后发展的其他类型的传输介质也可以用于在本地单元60和远程单元170之间提供期望的数据通信,而不背离本发明的范围。
图10是利用双向通信系统20的一种示例性的相互配合的数据流程图。在该相互配合中,医生可以下载调节要求,该调节要求随后由与患者在一起的临床医生手动执行。医生开始远程单元170和本地单元60之间的通信对话,如步骤220所示。对话可以经由因特网线路190或者通过关于图9描述的任何其它通信线路通过传输电子邮件或即时消息开始。在该通信对话过程中,医生可以下载指令到存储器138中,或者可以上传之前存储的从装置22或外围设备178获得的数据,如步骤222所示。该数据可以包括流体压力、重量历史、或患者的依从性报告。在上传数据之后,医生可以评估数据并确定是否需要调节装置,如步骤234所示。如果指示调节,医生可以下载调节要求指令到本地单元60,如步骤224所示。本地单元60将要求存储在存储器138中,用于随后临床医生的动作,如步骤226所示。在患者在时,临床医生从存储器138访问要求。然后,临床医生将注射器插入到注射端口36的隔膜76中,并且按要求中的指示添加或抽回流体体积。在调节之后,临床医生在植入物上布置天线54并指示微控制器106将压力测量值从传感器84传输到本地单元60。压力测量值由本地单元60中的微处理器136上传到远程单元170,如步骤230所示,以向医生提供确认已经执行调节指令并且指示在患者身上的最终效果。在一种离线调节中,基本单元在下载调节要求之后终止与本地单元60通信,如线路229所示,或者如果未指示调节在接收患者数据之后终止与本地单元60通信,如线路231所示。
除了步骤220-234的离线调节对话外,医生可以开始实时交互调节,如步骤236所示,以便在调节之前、过程中和之后监测患者的状况。在该情况中,在患者与临床医生在一起时医生下载调节要求,如步骤237所示。临床医生将注射器插入到注射端口36的隔膜76中,并且添加指定量的流体或从贮液池80中抽出指定量的流体,如步骤238所示,以执行要求。在注射之后,医生指示临床医生在植入物上方布置天线54,如步骤241所示,以将流体压力测量值从植入物传输到本地单元60。然后,压力测量值通过线路180被上行链接到医生,如步骤243所示。医生在步骤245评估压力测量值。基于该评估,医生可以通过线路180提供进一步的指示,以如线路242所示重新调节带。另外,医生可以向患者提供指示采取具体行动,例如进食或喝水,以测试调节,如步骤244所示。在患者执行测试时,医生可以上传来自植入物的压力测量值,如步骤246所示,以评估在食物或液体试图通过人造口时施加到带的蠕动压力。如果压力测量值过高,指示可能阻塞,医生可以立即向临床医生传输附加指令信号以重新调节带并解除阻塞,如线路249所示。在医生满足于调节结果之后,通信对话在步骤232终止。如流程图所示,通信线路180使医生和患者能够在实际的处理对话中相互配合,在该实际的处理对话过程中,医生能够要求调节并接收实时的流体压力反馈以评估处理的效力。
在第二种示例性的相互配合中,如图11所示,医生下载用于可远程调节的装置的调节要求,该装置例如如图6所示的注入器115。医生通过线路180开始该通信对话,如步骤220所示。在开始通信之后,医生从本地单元60的存储器138上传之前存储的数据,例如流体压力历史值。医生评估数据并且确定是否指示调节。如果医生选择离线调节,那么调节指令被下载到本地单元60并且存储在存储器138中,如步骤224所示。根据存储在存储器138中的要求,患者在方便时将天线54布置在植入物区域上方并且开始通过本地单元60调节,如步骤233所示。然后,本地单元60将功率和指令信号传输到植入的微控制器106以执行调节。在调节之后,患者建立与远程监测单元170的通信线路并且上传一系列来自植入物的压力测量值到远程单元。这些压力测量值可以存储在远程单元170的存储器174中,直到医生访问。
在一种替代的情况中,患者可以在与医生的实际处理对话过程中执行实时调节。在该情况下,医生通过线路180建立与患者的通信。一旦通过线路180连接,医生指示患者在植入物区域上方布置天线54,如步骤250所示。在天线54就位之后,医生通过线路180下载调节指令到注入器115,如步骤252所示。在注入器115中执行调节的过程中和/或之后,通过线路180将一系列压力测量值从注入器115上行链接到医生,如步骤254所示。医生对由调节引起的流体压力变化进行即时观察。如果引起的流体压力水平过高或过低,那么医生可以立即重新调节限制带,如线路255所示。医生也可以指示患者执行具体动作以测试调节,例如喝水或进食,如步骤256所示。在患者执行测试时,医生可以上传来自压力传感器的压力测量值,如步骤258所示,以评估在患者试图使食物或液体通过人造口时施加到带的蠕动压力。如果压力测量值过高,指示可能阻塞,医生可以立即传输另外的指令信号以重新调节带并解除阻塞,如线路259所示。在医生满足于调节结果时,通信对话终止在步骤232。在本发明中,本地单元60总是从属于远程单元170,使得医生能够要求调节,并且患者被阻止通过本地单元60独立地执行调节。
在第三种示例性的通信对话中,如图12所示,患者可以通过利用用户界面140输入要求开始与远程单元170的相互配合,如步骤260所示。该要求可以是电子邮件或其他电子消息的形式。在步骤262中,患者的要求通过通信线路180传输到远程单元170。在远程单元170处,患者的要求存储在存储器174中,直到在患者方便时检索为止(步骤264)。在医生查看了患者的要求之后(步骤266),可以通过用户界面176输入指示并下载到本地单元60。医生可以与患者通信关于处理或决定以执行或否定具体的调节要求,如步骤268所示。如果医生在步骤269中确定需要调节,那么医生可以开始与图10和11的流程图中所示的那些类似的通信对话。如果不指示调节,那么基本单元在响应步骤268的通信之后终止对话。
除了上述的情况,医生可以在任何时间访问本地单元60以检查患者在之前的调节指令下的依从性,或者提醒患者执行调节。在这些相互配合中,医生可以接触本地单元60以要求从存储器138上传数据,或者传输存储在存储器138中并且在患者下次打开本地单元60时显示的提醒。另外,本地单元60能够包括报警元件,以提醒患者执行常规设定的调节,例如每日放松。
如上所述,通信系统20能够用于将流体压力历史值上行链接到远程单元170,以允许医生在指定的时间段内评估装置22的性能。图13示出了可以与本发明的通信系统22结合使用以记录在一段时间内的流体压力测量值的数据记录器270。在本实施例中,数据记录器270位于患者体外,并且定位在注射端口36植入患者体内的上方区域上。在另一种实施方式中,数据记录器270也被植入在患者体内。如图13所示,数据记录器270包括TET线圈285和遥测线圈272,它们可由患者穿戴以便与被植入部分24靠近地定位。TET线圈285可为植入物提供功率,而遥测线圈272可询问植入物并可通过次级遥测线圈114接收数据信号,包括流体压力测量值。在另一种实施方式中,TET线圈285和遥测线圈272可被结合成单个线圈并可以任何合适的速率在TET和遥测功能之间交替任何合适的持续时间。
限制带28中的流体压力可被反复感测并以足以测量施加到带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10-20个压力测量值的范围内。如图13所示,当端口植入在患者的腹部区域中时,数据记录器270可以围绕患者的腰部穿戴在带274上,以相邻注射端口36定位线圈272。替代地,当注射端口36被植入在患者胸骨上时,数据记录器270可以围绕患者的颈部穿戴,如装置270′所示。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流体压力变化。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流体压力数据被下载到本地单元60的存储器138中。流体压力历史值可在随后的通信对话期间从存储器138上传到远程单元170。作为替代,流体压力数据可使用通信线路180直接从数据记录器270上传到远程单元170。
图14更详细显示了数据记录器270。如图14所示,数据记录器270包括用于控制与被植入装置24遥测通信的微处理器276。微处理器276与存储器280连接以便除此之外至少存储来自装置24的压力测量值。在该实施方式中,存储器280包括40Mb的静态随机存储器(SRAM)并且被构造成存储100小时的带时间标记的压力数据。当然,可以使用任何其他类型的存储器280,并且存储器280可以存储任何数量和任何其他类型的数据。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,包括但不限于闪存存储器,硬驱存储器等。虽然在该例子中数据记录器270是可操作的,但流体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。在该实施方式的一种形式中,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。在该实施方式的另一种形式中,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282都可被使用。
为了记录流体压力,微处理器276可最初经TET驱动电路283和TET线圈285将功率信号传递到被植入部分24。在传递功率信号之后,微处理器276可经遥测收发器284和遥测线圈272将询问信号传递到被植入部分24。询问信号可由遥测线圈114截取并传递到微控制器106。微控制器106可经收发器158和次级遥测线圈114发送来自传感器84的响应的温度调节的压力读数。压力读数可通过遥测线圈272被接收并由收发器284引导到微处理器276。微处理器276随后可存储压力测量值并启动下一询问要求。
当患者结束测量和记录流体压力时,数据记录器270被除去并且记录的压力数据被下载到本地单元60或者直接下载到远程单元170。如图9和14所示,数据记录器270可包括使用电话线288将感测的流体压力数据直接传递到远程单元170的调制解调器286。患者可将记录器调制解调器286与电话线连接,对医生的调制解调器拨号,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传递到包括在远程单元170中的微处理器172。作为替代,数据记录器270可包括用于将记录器与本地单元60连接的USB端口290。记录器USB端口290可与包括在本地单元60上的USB端口198连接(如图8所示)并且“发送”开关被启动以将压力数据下载到本地单元中的存储器138中。在压力数据被下载之后,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身体上以便继续进行压力测量。
图15是在取样时间阶段通过本地单元60或数据记录器270的反复询问过程中由传感器84测量的示例性的压力信号294的图形表达。压力信号294可以使用本地单元60的图形用户界面140或远程单元170的图形用户界面176显示。在图15所示的实施例中,在患者稳定时,带28中的流体压力最初被检测,得到所示的稳定的压力读取值。接下来,对带38进行调节以减小胃人造口的尺寸。在带调节期间,压力传感器84连续检测流体压力并将压力读取值通过患者皮肤传输到本地单元60。如图15中的图形所示,流体压力随着带的调节而增大。
在所示的实施例中,在调节之后要求患者喝点液体来检查调节的准确性。在患者喝的时候,压力传感器84连续检测由于吞咽液体的蠕动压力而产生的压力峰值。医生可以从远程位置评估这些压力峰值,以评估并指导对患者的处理。如果图形指示压力峰值超过期望的水平,那么医生可以通过通信系统20立即采取校正措施并且观察校正措施的结果,直到获得期望的结果。因此,通过通信系统20,医生能够执行调节并且可视地查看调节的结果,即使当位于与患者有相当距离处。
除了调节之外,通信系统20能够用于在一段时间内跟踪摄入限制装置的性能。具体地,来自数据记录器270的压力测量值的取样可以上传到医生的办公室用于评估。医生可以可视地检查压力读取值的图形,以评估限制装置的性能。可以理解的是,长期压力数据可以有助于看出一天当中患者何时进食或喝水以及进多少食或喝多少水。因此,这种数据可以有助于柔顺性管理。
压力测量记录表也可以常规地传输到远程监测单元170,以向医生提供分析工具,以确保食物摄入限制装置能够有效地操作。例如,压力数据可以有助于看出带28的压力或紧密度变化了多少,并且带28是否时常易于阻塞。如果任何不正常出现,医生可以使用通信系统20联系患者并要求另外的生理数据、要求调节或如果元件允许,操纵调节。具体地,通信系统20可以用于检测带28中的无压力状态,指示流体泄露。替代地,系统20可以用于检测带28中的过度压力峰值或压力保持在固定水平,这可以指示导管40扭结或人造口内阻塞。
本地单元60、另一种类型的对接站360、远程单元170或一些其它装置还可以包括逻辑,该逻辑被构造成处理压力数据并在检测到压力明显变化或在其他预定情况下主动地向医生、患者或任何其他人提供报警。这种报警可以包括任何以下方式:电子邮件、电话、听觉信号或任何其他类型的报警。报警的情况和/或报警的类型也可以相对于报警的接收器而改变。例如,关于向医生的报警,这种报警可以被限制为指示被植入部分24的一些元件结构上失效(例如,导管40中的扭结、带28破裂等)。关于向患者的报警,这种报警可以被限制为指示患者进食过多、过快或者如果咬合尺寸过大等。本领域普通技术人员可以想到可以向医生或患者提供指示的报警的各种其他情况。另外,可以理解,医生和患者可以在相似的情况下接收报警,或者医生或患者可以简单地根本不接收报警。
在本地单元60具有允许患者查看压力数据的图形用户界面时,本地单元60可以由患者使用以评估在家的压力读取值并且在带28压力降到指定基线下时通知他们的医生指示需要装置的调节。因此,通信系统20在利用肥胖治疗装置对患者处理过程中作为诊断和监测工具具有益处。通过通信系统20评估摄入限制装置22的便利性有利于频率更高地监测并且元件允许装置的调节。
本地单元60的图形用户界面、远程监测单元170或在通信系统20中的另外的外部或生理监测装置能够提供各种基于来自限制装置22的数据或信息或与其相关的屏幕显示。此外,在一些实施方式中,数据记录器270能够具有这样的图形用户界面。屏幕显示可以包括关于由限制装置22得到的测量值的信息,例如在可填充流体的限制装置中感测的流体压力的测量值或其它参数(例如,脉冲宽度、脉冲时间、脉冲幅度、脉冲数或脉冲频率、所感测的特征等),或者关于生理事件、状况(例如限制装置22的状况,例如其限制的或填充的状态)或趋势的信息。例如,图19A示出了屏幕显示1900的一种示例性的实施方式,该屏幕显示1900可以用作图形用户界面的一部分。如图所示,屏幕显示包括压力-时间曲线或图形1902,其示出为线性图但也可以是柱状图、散射图、或实际上任何其它图形表示。沿着水平轴线1901的时间刻度可以自动地改变尺寸以适应压力数据的数量或者能够由用于调节,例如以便检查感兴趣的时间间隔。屏幕显示1900还可以包括外部指示器1904,如图所示,其数字式提供了在显示屏幕1900上的出现,包括示出了压力的稳定状态或基线值的基线指示器1906和示出了脉冲数(例如,脉冲可以是表示患者吞咽的蠕动收缩或由其引起的压力脉冲)的脉冲指示器1908。在一些实施方式中,该信息可以通过用户输入获得(通过“基线设置”按钮1912或者通过视觉地输入检测脉冲,等等),但是在很多实施方式中,该信息可以通过一个或多个算法对来自限制装置22和/或数据记录器270压力或其他数据进行分析、滤波或以其他方式进行处理,这将在下面更详细地描述。本地单元60、远程检测单元170或其他装置可以执行这些算法并且连续地更新屏幕显示1900的结果。屏幕显示1900也可以包括记录控制器簇,以允许用户控制何时将压力记录或记载入日志文件,并且这样的日志文件的地址可以显示在窗口1924中。另外,注释功能可以通过控制器1914提供。在其他方式中,显示器1900可以包括来自先前拜访的压力读数(例如,相同患者的先前拜访,或者限制装置的先前调节),和/或表示吞咽、心率、呼吸率或者实际上任何其他生理参数的先前蠕动事件的压力读数。屏幕显示1900还可以包括患者的姓名或其他识别信息,以及注解、活动列表或患者指导手册等等。
在图19A中,屏幕显示1900具有菜单1916,该菜单1916包括三个图形或图标1918,1920,1922。选择这些图标的每一个都可以导致出现不同的显示屏幕。如图19A所示,选择了第二图标1920,并且显示出感测压力-时间图1902。选择第一图标1918可以产生如图19B所示的屏幕显示1930,其通过仪表1932指示压力。在该实施方式中,仪表1932是竖直的且线性的,但是可以使用各种其他定向和形状,诸如水平的圆形仪表等等。仪表1932可以包括能够分成一个或多个区域或范围1936a-c的离散指示器或条1934。如图所示,三个离散的压力范围1936a-c可以具有界限(在该例子中,80至140mmHg,0至80mmHg,以及-10至0mmHg),但是可以提供任何数量的压力范围,并且它们的大小和端点可以调节。本领域技术人员能够理解,范围1936a-c可以由医生或其他用户设定并且可以因患者而异。在一些实施方式中,压力范围1936a-c能够与可植入的限制装置的状态相符,例如最高范围可以指示限制装置被过度填充或过度拉紧,中间范围可以指示限制装置被最优地填充或最优地拉紧,而较低范围表示限制装置没有充满或者松弛。在使用中,压力可以由标记物1937指示,该标记物1937可以表示当前压力、平均压力或者与压力有关的其他量度。在一些实施方式中,标记物1937可以沿着仪表1932连续运动,在其他实施方式中,标记物1937能够以离散方式逐条1934运动。屏幕显示1930也可以包括很多与图19A所示的屏幕显示1900中的界面元件相同或类似的界面元件,诸如记录控制器组1910,显示日志文件位置的窗1924,和/或注释控制器1914。
回到图19A,选择第三图标1922可以导致如图19C所示的脉冲计数计数显示1940,用于计算脉冲序列中的脉冲数量。脉冲序列可以表示诸如吞咽的蠕动事件。屏幕显示1940可以包括圆形仪表1944,围绕该圆形仪表1944的周边设有编号或指示器。在使用中,指针1932可以在仪表1944内旋转以提供在脉冲序列中检测到的脉冲数量的指示。文本指示器1946,1948也可以用于指示在当前或过去的脉冲序列中的脉冲数量。控制器1950可以重新计数。
可以给压力、脉冲和其他生理参数和事件提供大量其他屏幕显示。例如,图20示出了压力-时间的交变波形屏幕显示2000,其提供了通过文字标记2002沿着x轴描绘的时间刻度。在该屏幕显示2000中,通过限制装置22感测的压力可以绘制成波形2004。另外,任何屏幕显示、任何指示器、仪表、图或其中的其他显示元件可以用于发出警报信号。例如,当压力或其他参数超过阈值时,压力图形1902、文字指示器1904或仪表1931、1944(或其他显示元件)可以闪烁。警报也可通过屏幕显示的亮度变化(例如颜色、强度、色调等可以变化)或者警告消息或其他视觉警报来指示。除了视觉警报之外或者替代视觉警报,可以包括听觉警报。本文描述的任何屏幕显示都可以使用绿-黄-红色条、圆或其他典型的几何图形、图表或指示器,其中当感测到参数变化时色彩发生变化。例如,当人造口接近闭塞时(例如由压力或其他方式指示),指示器的颜色可以变红,因为这可能是危及健康,但是当限制装置松弛时(例如由压力或其他方式指示),指示器的颜色可以变黄,因为这可以不作为威胁生命的问题考虑。在一些实施方式中,这样的颜色可以使用彩色发光二极管(LED)或液晶显示器(LCD)实现。
图21示出了指示压力(例如,当前压力或在屏幕显示2000的
选定点处的压力等等)的屏幕显示2100的一种替代实施方式。屏幕显示2100可以包括被分成离散分段2102的竖直仪表2103。每个分段可以表示一组压力并且当感测的压力在所述压力组内时点亮。如图21所示,分段2114被点亮。标签2104、2112可以识别所述压力组。分段2102可以归组成零或者由颜色区分的范围。如图21所示,仪表2103包括分别与高压、中压和低压对应的三个范围2106,2108,2110(例如:红,黄,绿)。范围2106,2108,2110可以是由用户配置的并且可以对应于各种状态,例如,高范围可以对应于限制装置22过于拉紧,等等。可以由绿色表示的中等范围可以对应于最优限制的调整范围。在使用中,仪表2100可以显示静态和/或动态的压力测量结果。例如在静态测量结果中,仪表2100可以呈现基线压力或由限制装置22感测的压力,这在所述装置22的植入或调节后是有利的。例如在动态或瞬时测量中,仪表2100可以呈现在吞咽事件期间限制于装置22中检测出的压力。因此,点亮的分段2102可以随着压力的变化而上升和下降。
图22示出了指示压力的屏幕显示2200的另一种替代实施方式。在所示的实施方式中,屏幕显示2200是圆形仪表2202的形式,围绕该仪表2202的周边设有旋转指针2206和标签2204。所述仪表2202可以分为能够如以上所述工作的多个区域或范围2208。在使用中,指针2206可以旋转以指向压力读数,诸如基线压力、平均压力、静态或动态压力等等。
图23A示出了呈现与参数的脉冲序列有关的信息的屏幕显示2300的替代实施方式,诸如在吞咽事件中与压力脉冲一起发生。如图所示,屏幕显示2300包括脉冲幅值-脉冲计数图2302。在其他实施方式中,可以取代压力显示另一参数的大小。脉冲计数可以与脉冲序列中的脉冲数量对应。例如如图所示,脉冲标签2304识别出七脉冲序列中的第六脉冲。应当注意到,虽然图23A所示的例子显示了7个脉冲,但是可以确定和显示任何数量的脉冲。在使用中,竖直条2306可以指示脉冲序列中每个脉冲的脉冲幅值。每个竖直条2306a-g可以由分段或离散指示器2308组成,每个离散指示器2308可以表示压力或压力组。竖直条的高度可以表示压力的大小或幅值,其可以是绝对压力读数或从基线压力或其他压力基线的压力变化。在使用中,当检测到脉冲时可以显示竖直条2306a-g。例如,当由限制装置22检测到的压力上升时,屏幕显示2300可以在图2302的左手边呈现上升的竖直压力条2306a。如果该压力上升被认为是脉冲,其例如可以通过算法来确定(参见下文的描述),则竖直杆2306a可以上升并且停留在脉冲峰值处,并且在底轴2308上可以呈现脉冲计数“1”。如果发生了另一个脉冲,这另一个条2306b可以呈现类似方式,其中脉冲计数下面的读数为“2”。这可以继续,直到压力不再展现脉冲事件,直到用户指示所述时间结束,直到脉冲变得罕见(通过例如脉冲间隔周期来测量),或者直到通过预定的定时器的终止,等等。作为图解,图23B示出了一组屏幕显示2312,如其在两脉冲序列中可能出现的那样。
屏幕显示还可以包括用于脉冲的时间标记。例如,如图23A所示,时间标记2314可以设置在脉冲计数数字附近以便指示检测到脉冲的时间(例如在采样时间周期内的4秒时刻),或者替代地,时间标记可以指示测量到的脉冲持续时间(例如脉冲为4秒长),自最后脉冲(例如自开端、峰值或终点,前一脉冲的其他点开始的4秒)以来的时间,或者与脉冲有关的各种时间量度的任何一个。本领域技术人员能够理解,虽然图23A示出了一个时间标记2314作为例子,但是时间标记也可以与其他脉冲结合。
图24至28示出了本地单元60、远程监测单元170、数据记录器270或其他装置的图形用户界面的其他示例性屏幕显示。一般而言,这些屏幕显示可以呈现人造口、限制装置和/或周围的生理机能的静态或动态图像,所述生理机能可以变化或通过限制装置感测的参数(例如压力)表示。屏幕显示可以是依次显示或在适当时刻显示的静止图像,或者其他种类的图像。例如,图24A示出了一种示例性的屏幕显示2400,其具有由限制装置2404包围的范围的布置(disposition)的模拟图,其在该例子中包括由限制装置2404包围的食管和人造口2402的断面。该图可以显示限制装置2404在所述范围上的尺寸、形状、构造和效果,或者范围的布置的其他方面。本文中仅仅作为例子示出了食管和人造口2402区域,实质上可以示出体内的任何区域,尤其是任何解剖学腔。
在使用中,屏幕显示2400可以根据由限制装置感测的压力变化。例如,图24B-C示出了在压力升高时可能出现的屏幕显示2400,其中人造口2402尺寸减少并且周围组织变得更加收缩。在一些实施方式中,屏幕显示2400可以被连续地更新(如直播屏幕显示那样),但是在其他实施方式中,其可以包括显示为必须的静态或静止图像,每个图像对应于一个压力范围。例如,图25示出了压力在时间间隔上的示意性性曲线,并且包括带有标签A、B、C的三个分段,每个分段展示不同的感测压力。图24A可以对应于分段A,图24B可以对应于分段B,而图24C可以对应于分段C。在一些实施方式中,分段A、B、C可以对应于限制装置2404的状态,诸如限制装置2404的限制状态或填充状态,例如,分段A可以与限制装置过于松弛或未充满相互关联,分段B可以表示最优调节,而分段C可以表示限制装置的过分拉紧或者过分填充。在其他实施方式中,屏幕显示2400可以根据不同的感测脉冲幅值、脉冲计数或者脉冲频率等等变化(这样的脉冲信息例如响应于诸如吞咽水的标准化测试获得,或者通过监测预定时间上的脉冲特性来获得)。
屏幕显示2400可以具有各种其他构型。在一些实施方式中,可以在屏幕显示2400上显示一条或多条基线、等量线或其他指示器。例如,在屏幕显示2400上可以显示圆(或者一个或多个同心圆),从而允许医生或其他用户更加容易地看出人造口2402的尺寸变化或范围的布置的其他变化。在一些实施方式中,可以选择并标记圆的尺寸以指示测量压力,例如,圆上的标记可以表示感测的压力,当人造口或开口2402的尺寸基本上与圆的尺寸相配时,感测的压力可能大致等于标出的压力。诸如感测压力和/或限制装置的状态的信息也可以以文字的方式或者通过使用颜色显示在屏幕显示2400上,例如,当人造口接近阻塞时,人造口的图像变红,等等。
另外,如图24A-C所示,屏幕显示2400表示断面图像,在其他实施方式中,可以提供其他二维图像(诸如侧视图,限制装置单独的视图,等等)或三维图。图26A-C示出了带三维模拟图的示例性屏幕显示2600。如图所示,屏幕显示2600包括食管和一部分胃的外部的三维分布图。可以看到,限制装置2602包围胃的上部。屏幕显示2600进一步可以包括从胃的上部拆下的限制装置2602的图形2604,该图2604提供了穿过限制装置的开口2606的视图。标签或其他箭头可以用于提供与开口2606的尺寸和形状有关的信息。三维屏幕显示2600可以根据压力变化而更新,如以上结合图24A-C和25描述的那样。例如,图26A可以被显示成对应于分段A(如图25所示),图26B可以显示为对应于分段B,而图26C可以显示为对应于分段C。箭头2608,2610和2612指向进入胃(例如在吞咽后)的食物颗粒的示例性视图,其可以包括在图26A、26B和26C的每一个中。如在该实施方式中所示,图26A示出了最大量的食物颗粒,对应于限制装置的低压和/或较松弛配合(相对于图26B和26C而言)。图26C示出了最少量的食物颗粒,对应于限制装置的较高压力和/或较紧配合(相对于图26A和26B而言)。图26B示出了介于图26A和26C之间的食物颗粒数量,对应于介于图26A和26C的压力和/或配合之间的压力和/或配合。
屏幕显示2600可以基于或本身可以是从身体获得的实际图像,诸如荧光图像,并且可以包括静止图像或连续更新的图像(诸如录像)。在一些实施方式中,屏幕显示2600可以显示经过由限制装置2606限定的开口的硫酸钡。由于允许用户观察组织在吞咽过程中如何变化和/或显示经过处在已知设置(例如已知的填充体积)的限制装置2606的荧光介质(例如硫酸钡)的荧光图像,这样的结构可能是有利的。荧光图像可以基于患者自身的荧光透视法或基于一般图像,它们的任何一种都可以由用户拍摄并且载入外部装置中。然后,选出的与患者体型(或一般图像)相配的患者图像或一般图像可以根据感测的压力显示。图27A-B示出了表示与检测的压力相符的荧光图像的示例性屏幕显示2700。例如,图27A可以对应于图25中的分段A,而图27B可以对应于分段B。对于与限制装置有关的生理学状态而言,荧光屏幕显示也可以是有利的。例如,图28示出了基于荧光图像的另一种示例性屏幕显示2800。吞咽荧光介质但是出现不明显的压力变化或压力脉冲(例如由限制装置感测的压力)的患者可能遭受食管蠕动衰竭,其中重力是引起物质经过食管的唯一力或者主要力。图28所示的屏幕显示2800呈现了限制装置2802和食物团(bolus)袋2804的图形,并且可以用于诊断该状态或合适检测该状态。也可以使其他的医学成像方法,诸如X射线、核磁共振成像(MRI)等等。
如前所述,本地单元60、远程监测单元170或其他外部装置的图形用户界面可以适合于呈现历史趋势或数据分析,例如基于由数据记录器270捕获的参数数据。例如当患者拜访医生以检查进展、处理并发症和/或调整可植入的限制装置22时,这样的功能可能是有用的。在一种示例性的实施方式中,如图29所示,屏幕显示2900可以呈现在时间间隔中的压力图形或曲线,但是也可以显示其他生理参数,诸如心率、血压、呼吸率等。屏幕显示2900可以包括多组数据,例如第一时间间隔(例如,第一次拜访医生)的数据的趋势线2902或其他图形表示方法,以及随后的时间间隔(例如第二次拜访医生)捕获的数据的另一条趋势线2904或图形表示方法,该另一条趋势线2904叠加在第一时间间隔的趋势线2902上。来自两个不同时间间隔的数据的叠加可以允许用户比较这些趋势线。在一些实施方式中,随后的时间间隔可以在一些重大医疗事件(诸如限制装置22的调整)后发生,并且数据的叠加允许评估对限制装置22的调整。虽然图29示出了由吞咽水引起的压力-时间间隔的例子,但是可以使用来自任何源或时间间隔的压力。另外,大量数据可以以这种方式绘制,包括重量、重量减轻、体重指数、身体尺寸、带内压力、心率(休息和在锻炼情况下)、呼吸率(休息和在锻炼情况下)、通过图解,图30示出了示例性的屏幕显示3000,该屏幕显示3000将表示患者在限制装置的一次调整后的呼吸率的趋势线3002与表示在随后的调节之后的呼吸率的趋势线3004叠加。不同类型的数据可以用叠加方式呈现(例如,压力趋势线与心率趋势线叠加)。
图31A示出了呈现人群或患者组的数据的一种示例性屏幕显示3100。人群数据可以来自各种数据集,包括由医生收集的数据、地方数据、全国数据,和/或从较大的数据集选出的数据,以便与具体患者的体型(或其他重要的生理学/医学特征)相配。可以绘制和比较各种参数,但是如图所示,屏幕显示3100呈现了可填充流体的限制装置的压力-填充体积曲线。其他参数,诸如脉冲计数、脉冲幅值、脉冲大小、脉冲宽度、脉冲幅值和脉冲频率,也可以相对于填充体积绘制,并且如前所述,这样的脉冲信息可以例如响应于诸如具有标准体积和/或粘度的水或食物团吞咽的测试来获得,或者通过监测在预定时间内的脉冲特性来获得。屏幕显示3100还可以包括多条趋势线3102(但是可以使用条形图、发散图或数据的其他图形表示方法),每条趋势线绘制来自患者的数据,如在符号表3104中所示。更具体地,趋势线3102可以表示在限制装置的给定填充体积下对每位患者感测的压力(基线压力、平均压力、或任何其他压力测量结果)。在一些实施方式中,该数据可以来自数据记录器270,但是在该例子中,趋势线3102表示通过每次给限制装置22增加已知量的液体(例如1ml)并且测量得到的压力来获得静态体积测量结果。可以看到,趋势线3102在每个体积下呈现一压力范围,这可能是由于患者间的人体或限制装置放置和配合的可变性。屏幕显示3100可以用于允许医生或其他使用者看出一位患者与另一患者或人群的比较。
图31B示出了表示患者群的压力数据的另一种示例性的屏幕显示3150。如图31B所示,屏幕显示3150包括压力-填充体积曲线。屏幕显示3150包括表示患者组或患者群的标称压力值的趋势线3152。在该实施方式中,标称值是平均值,但是在其他情况下,标称值可以是中点值、加权平均值、极小值、极大值、范围、标准差或者任何其他数学计算结果。屏幕显示3150也可以包括上界趋势线3154和下界趋势线3156,其一起可以限定围绕标称值的范围3158。在一些实施方式中,特定患者的趋势线可以叠加在屏幕显示3152上,揭示出患者在什么地方相对于群体下降。在其他实施方式中,屏幕显示3152可以在没有叠加特定患者的数据的情况下呈现。
屏幕显示还可以提供注释历史数据,尤其是在延长的时间间隔中(例如通过数据记录器)收集的数据的能力。图32示出了外部装置3200,诸如带显示器3202的本地单元60。应当理解,外部装置3200可以表示用于显示和/或生理监测的任何外部装置,包括远程监测单元170。如图所示,屏幕显示3200呈现了压力值在时间间隔中的曲线并且提供了使用下拉菜单3204注释曲线值的能力。菜单3204可以包括对预定事件3206(诸如执行测试、症状、用户或医生的观察等等)的各种描述。作为图解,在图32中,注释3210设置在波形3208上并且包括指示在特定时间点发生“吞咽20ml水”的注释标记2310。用户可以用各种方式注释历史数据。例如,外部装置3200可以适于家庭使用,并且患者可以注释每天的事件。如果数据记录器270例如在若干天期间捕捉数据,则这样的实施方式可能是有用的。替代地,外部装置3200可以由医生在患者拜访期间或者当限制装置22被调整时更新。医生可以注释每天的数据,或者可以执行另外的测试(诸如吞咽水)以产生与每天监测分开的数据记录。应当理解,虽然屏幕显示3200呈现了用于注释的预定事件,但是在很多实施方式中,用户可以建立他们自己的用于注释的用户定义事件,和/或可以输入关于数据值的自由形式的描述。图33示出了外部装置3200上的一种示例性的实施方式的屏幕显示3300,其中可以将描述输送文本框3302中。在一些实施方式中,图像或图标也可以用于描述,例如杯形图标可以表示“吞咽水”事件。
呈现带注释的数据的能力不限于压力数据。例如,图34示出了包括图形表示的屏幕显示3400,所述图形表示在该情况下体重减轻-时间的条形图,条3402的幅值对应于体重减轻的量。如图所示,条3402用于一组日期3404。用于可以在文字框3406中输入与每个条3402的注解或注释和/或日期3404,这可能有助于跟踪和/或揭示患者生活中影响体重减轻的事件。外部装置3200可以包括小键盘3408或用于该目的的其他用户输入装置。
任何或所有前述屏幕显示实质上可以任意组合以建立用于本地单元60、远程监测单元170、数据记录器270或其他生理学监测装置的图形用户界面。在一些实施方式中,远程服务器可以设置用于允许用户将他们需要的屏幕显示和/或屏幕显示元件下载到本地单元60或远程单元170。例如,显示屏、显示模式、视觉皮肤、桌面图像、屏保以及其他屏幕显示配置的库可供下载,从而允许用户对装置的图形用户界面进行本地化。另外,远程服务器可以提供存储和归类已被用户本地化或设计且下载的屏幕显示和/或屏幕显示元件的能力。这样的功能可以允许用户与他人交换和分享屏幕显示元件。
另外,本文所述的图形用户界面和/或屏幕显示的任何一个或所有可以通过修改、改变、擦出、改编、更新、修订、增加等等进行重新布置(repurpose)。例如,可以获得具有图形用户界面的装置,并且可以通过经由本地单元60、远程单元170或其他生理学监测单元的数据输入端口或对接站(例如如图8所示的USB端口198)编制适当的软件来完成期望的修改。在其他实施方式中,这样的修改可以通过遥测方式执行。例如,可以增加另外的图标、图形、指示器等等,屏幕显示根据具体用户进行本地化,等等。这样的技术的用法以及获得的装置都落在本申请的范围内。
图16中示出了数据记录系统300的替代实施方式。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通过电缆356通信。电缆356可从线圈头354和数据记录器370拆下。当然,应当理解,电缆356仅仅是示例性的,并且可以使用任何适当的替代方式,包括但不限于无线发射器/接收器系统。在该例子中,线圈头354戴在患者颈部周围,并且通常设置在注射端口36上方。数据记录器370戴在围绕患者腰部的带274上。当然,这些相应的位置仅仅是示例性的,并且应当理解,线圈头354和数据记录器370可以设置在任何地方。仅仅作为例子,如果注射端口36被植入患者的腹部,线圈头354可以戴在带274上。还应当理解,线圈头354和数据记录器370在图16中仅仅是为了显示的目的而显示为单个模块,线圈头354和数据记录器370的任何一个可以具有各种形状、尺寸和构造。
图17示出了数据记录系统300的示例性组成元件。如图所示,数据记录器370包括微处理器276、存储器280、电源282、USB端口290和用户界面292。线圈头354包括TET驱动电路283、遥测收发器284、TET线圈285和遥测线圈272。TET驱动电路283能够通过电缆356接收来自电源282的功率。TET驱动电路还能够通过电缆356接收来自微处理器276的信号。遥测收发器284能够通过电缆356接收来自微处理器276的信号并且将信号传递给微处理器276。在另一种实施方式中,遥测收发器284仅仅能够将信号传递给微处理器276。应当理解,图17所示的很多组成元件与图14所示且配有文字描述的组成元件类似。相应地,参照图14对这些组成元件的以上描述也可以应用于图17所示的组成元件。在该例子中,线圈头354和数据记录器370可以看成将(上述)包括数据记录器370的组成元件分成物理上分开的单元。还应当理解,图17所示的任何组成元件及其相互关系、功能等可以通过适当方式改变。
在该例子中,线圈头354在构造和功能上类似于上述天线54。线圈头354的TET线圈285能够给注射端口36提供功率。当然,如果在患者体内植入能够从TET线圈285接收功率的任何其他装置(例如泵等),TET线圈285也可以给这样的装置提供功率。TET线圈285所提供的功率可以通过TET驱动电路283调节并且提供给TET线圈285,TET驱动电路283本身可以通过电缆356从电源282接收功率。提供给TET驱动电路283的这些功率可以由微处理器276通过电缆356进行调节。另外或者替代地,微处理器276可以调节TET驱动电路283给TET线圈285提供功率的方式。本领域技术人员能够想到这些组成元件之间的其他适当结构和关系以及他们的其他工作方式,还应当理解,虽然本例子关注于通过TET线圈285发送RF信号,但是可以使用任何其他类型的功率技术以及替代的功率通信装置。
线圈头354的遥测线圈272能够接收来自注射端口36的线圈114的信号,包括指示可植入的装置内的流体压力的信号(例如所述注射端口36内、导管40内、和/或可调节的束带28内的流体压力,使用压力传感器84获得压力,等等)和指示温度的信号。应当理解,遥测线圈272也可以接收表示来自任何其他源的任何其他类型的信息的任何其他类型的信号。遥测线圈272所接收的信号被传递给遥测收发器284,其能够通过电缆356将这样的信号传递给微处理器276。遥测收发器284可以在将信号传递给微处理器276之前对从遥测线圈272接收的信号进行任何适当的转化或处理。本领域技术人员能够想到这些组成元件之间的其他适当的构造和关系以及他们可能的工作方式。还应当理解,组成元件可以结合。仅仅作为例子,TET线圈285和遥测线圈272可以合并成单个线圈,并且能在任何适当的持续时间内以任何适当的频率在TET和遥测功能之间交替。另外,虽然本例子关注于通过遥测线圈272产生RF信号的应用,但是应当理解,可以使用任何其他类型的通信技术(例如超声、磁等)以及不同于线圈的替代通信装置。
数据记录器370可以在给定日接收压力测量结果并且将该测量结果存储在存储器280中,由此记录在患者的饮食和日常活动期间的流体压力变化。在该例子中,存储器280包括40Mb的静态存取存储器(SRAM)并且能够存储100小时的带时间标记的压力数据。当然,可以使用任何其他类型的存储器280,并且存储器280可以存储任何量和任何其他类型的数据。仅仅作为例子,可以使用任何其他类型的易失性存储器或任何类型的非易失性存储器,包括但不限于闪存、硬件驱动存储器等。在本例子的数据记录器370运行时,流体压力被读取并且以由微处理器276控制的指定数据传输率存储在存储器280中。在一种实施方式中,流体压力被重复感测并且传递给数据记录器370,然后以足以测量朝向可调节束带28的蠕动脉冲的更新速度存储在存储器280中。仅仅作为例子,更新速度可以在大约每秒10至20个压力测量结果的范围中。可以使用其他适当的更新速度。
在另一种实施方式中,被植入的部分24包括存储器(未示出)。仅仅作为例子,这样的植入存储器可以设置在注射端口36中或者其他地方。如果包括这样的植入存储器,则这样的植入存储器可以用于各种目的。例如,这样的植入存储器可以存储与数据记录器370的存储器280相同的数据,使得植入存储器提供了数据记录器370的存储器280的备份。在该应用方式中,这样的数据可以进一步保留在植入存储器中以供存档,可以每天替换、可以在数据记录器370将相同的数据传递给远程单元170之后替换或更新,或者可以以其他方式使用。还应当理解,植入存储器可以用于存储预选的信息或预选类型的信息。例如,植入存储器可存储最大压力测量结果和最小压力测量结果,患者吞咽的荧光图像或录像,和/或任何其他信息。本领域技术人员能够想到适于存储在植入存储器中的其他信息。还应当理解,可以植入任何类型的存储器,包括但不限于易失性(例如SRAM等),非易失性(例如闪存、硬盘驱动器等)或者其他存储器。
在该例子中,微处理器276通过电源282供能。在一种实施方式中,电源282包括可充电电池(未示出),诸如可充电电池。在该实施方式的一种应用中,可充电电池是可拆卸的并且可以使用充电单元充电,在对用尽的电池进行充电时可以使用另一个可充电电池进行替换。在该实施方式的另一种应用中,可充电电池通过将充电适配器插入数据记录器370和壁单元中进行充电。在本实施方式的又一种应用中,可充电电池通过无线充电单元以无线方式充电。在另一种实施方式中,电源282包括超级电容器,其也可以被充电。当然,可以使用任何其他类型的电源282。
本例子的数据记录器370可以构造成在不同情况下以不同方式给患者提供警报。例如,当流体压力急剧变化时,数据记录器370可以提供听觉和/或视觉警报。替代地,数据记录器370可以提供在至少部分地基于压力数据判定患者正在过多、过快饮食等时发出听觉和/或视觉警报。数据记录器370还可以在判定线圈头354与注射端口36无法正常通信时提醒患者注意。本领域技术人员能够想到在其他情况下数据记录器370可以向患者发出警报。还应当理解,用户界面292可以包括任何数量或类型的特征,包括但不限于扬声器、LED和LCD显示器,通/断(on/off)开关等。在该例子中,用户界面292能够给患者仅仅提供一个输出,并且不允许患者向数据记录器370提供输入。因此,本例子的用户界面292包括用于显示电源282充满电的绿色LED和用于显示电源282需要充电的红色LED。当然,用户界面292可以替代地允许患者向数据记录器370提供输入,并且可以包括任何适当的组成元件和特征。
如图18所示,数据记录系统300还包括对接站360。对接站360能够接收来自数据记录器370的数据通信,并且还能够向远程单元170传递数据通信。在该例子中,数据记录器370包括USB端口290,使得对接站360可以通过与USB端口290连接的USB电缆(未示出)接收来自数据记录器370的数据通信。在一种实施方式中,对接站360包括患者个人电脑。当然,对接站360可以用任何其他适当的方式接收来自数据记录器370的通信。例如,这样的通信可以通过无线方式传递(例如,通过RF信号、蓝牙、超宽带等)。
在另一种实施方式中,对接站360专门用于与数据记录器370连接并且包括能够容纳数据记录器370的摇篮形特征部件(未示出)。在该例子中,摇篮形特征部件包括能够与数据记录器370上的相应触点电结合的触点,以便在对接站360和数据记录器370之间提供通信。因此,对接站360可以与数据记录器370相关,其方式类似于用于个人数字助手(PDA)、BLACKBERRY.RTM装置、无绳电话等等。本领域技术人员能够想到数据记录器370和对接站360可以通过其他适当的方式通信或接合。还应当理解,在图18中示出的对接站360是台式电脑,这仅仅是示意性的,对接站360可以以各种替代形状,尺寸和构造提供。
在一种实施方式中,对接站360包括上述的本地单元60。因此,应当理解,以上有关图9所示的组成元件的描述也可以应用于图18所示的组成元件。类似地,诸如那些在图10至12所示以及在附带的文字中描述的方法也可以用于对接站360。在另一种实施方式中,数据记录器370包括本地单元60。在又一种实施方式中,数据记录器370设有AC适配器或能够操作以对电源282充电的类似装置,并且数据记录器370还包括以太网端口(未示出),使得数据记录器370能够直接与网络(诸如因特网)连接以将信息传递给远程单元170。因此,还应当理解,本文关于本地单元60和对接站360描述的特征和功能的任何一个可以结合在数据记录器370中或者可以另外分配。
在一种示例性用法中,患者整天戴着线圈头354和数据记录器370以将压力测量结果记录在存储器280中。晚上,患者从线圈头354解开数据记录器370并且将数据记录器370与对接站360连接。当数据记录器370和对接站360连接时,对接站360将从数据记录器370接收的数据传递给远程单元170。如果电源282包括可充电电池,对接站360可以进一步构造成在数据记录器370与对接站360连接的同时对电池进行充电。当然,本领域技术人员马上会想到,患者无需为了将数据记录器370与对接站360连接而将数据记录器370从线圈头354解下。还应当理解,作为在白天记录这样的测量结果的补充或替代,可以将晚上的压力测量结果记录在存储器280中,甚至可以全天二十四小时记录压力测量结果。因此,压力测量结果的获取和记录无需仅限于白天。还能够想到,每个压力测量结果并不一定必须被记录。
如上所述,数据记录器370能够接收、存储和传递与流体压力有关的数据。但是,数据记录器370可以接收、存储和/或传递各种其他类型的数据。仅仅作为例子,数据记录器370还可以接收、处理、存储和/或传递与温度、EK测量结果、患者的进食频率、患者进食的饭量、患者行走量等有关的数据。因此,应当理解,数据记录系统300可以构造成处理接收到的数据以产生用于传递给对接站360的附加数据。例如,数据记录器370可以处理通过线圈头354获得的压力数据以形成表示患者进食频率的数据。还应当理解,数据记录器370可以包括附加组成元件以获得非压力数据。例如,数据记录器370可以包括步数计或加速度计(未示出)以获得与患者完成的步行量有关的数据。由这样的附加组成元件获得的数据可以通过类似于压力数据的方式存储在存储器280中并且传递到对接站360。数据记录器370还可以包括用于获得有待进入内部流体压力测量结果的数据以便说明各种状态对流体压力的影响。例如,数据记录器370可以包括用于测量大气压力的压力计。在另一种实施方式中,数据记录器370包括倾斜仪或类似装置以确定患者的定向角度(例如站立、平躺等),这可以计入压力数据中以便说明由患者的定向引起的流体静压力。替代地,用于获得非压力数据的倾斜仪或其他装置可以在物理上从(例如已经植入的)数据记录器370分开。本领域技术人员能够想到其他类型的数据,获得这些数据的方式以及使用这些数据的方式。
由数据记录器270(或数据记录器370,或任何其他数据记录器)捕获的数据可以以各种方式进行处理和分析。在很多实施方式中,本地单元60、远程单元170、数据记录器270,370或其他外部装置可以构造成执行一种或多种数据处理算法,所述数据处理算法能够用于追踪并分析生理参数和事件并且还可以产生能够呈现在前述的图形用户界面中的结果。应当理解,捕获和/或存入的数据可以提供与各种感测参数有关的信息,包括但不限于压力(例如流体压力等)。感测参数也可以包括脉冲计数、脉冲宽度、脉冲幅值、脉冲持续时间、脉冲频率、感测的电特征(例如电压、电容等)等等。
一些数据处理技术或算法通常可以用于将数据滤波或调制(例如:转换、滤波或其他调制)成适于后续(由计算机或用户)分析或显示的形式。大量调制算法都是可行的。例如,图35A示出了由限制装置22(诸如束带28和压力传感器84)感测的压力值3502的曲线3500。在该示例性实施方式中,在时间间隔内从限制装置28的压力传感器84获得的压力信号中感测或采样压力值3502(如前所述,限制装置可以是任何类型的限制装置,包括可填充流体的或机械式装置)。感测的值可以由数据记录器370通过限制装置22的反复询问来捕获。应当理解,压力值仅仅作为例子使用,任何感测参数可以用于该算法,或者本文所述的任何其他算法中。图35A示出了以100Hz的频率收集到的值,但是实质上可以使用任何采样频率。压力值可以转换成有助于呈现重要现象(例如,吞咽事件引起的脉冲可能在0.1Hz量级上发生)、去除数据中的干扰和/或压缩数据集的大小等的较低频率。转化可以以各种方式完成,但是在一种示例性实施方式中,压力值3502可以是平均值,以有效地减少采样频率,其结果显示在图35B中,该图示出了压力值3502平均降低到10Hz频率的曲线3506。平均值可以通过在时间间隔内在曲线3500上定义平均窗(例如通过将时间间隔分成一组平均窗3504,每个为1/10秒),并且计算发生在每个平均窗内的压力值3502的平均值。所述窗可以通过时间限定(例如每10秒钟)或者通过数据点的数量来确定(例如,平均每10个值或数据点)。平均窗的大小可以由用户定义,并且在一些实施方式中可以根据重要现象或生理参数来定义。如本领域技术人员能够理解的那样,可以使用例如大量数学方法来替代平均法,100Hz的数据可以通过在10Hz频率下对压力数据进行采样而直接转变成10Hz的数据,换句话说就是向下采样或滤波。图35C-E示出了三条曲线3508、3510和3512,其呈现了将图35A中绘制的压力值3502转变成较低频率的结果。如图35E所示,一些低频现象(诸如脉冲3514、3516)仍然可以辨别,但是更小的幅值变化被去掉。图35F显示了示出平均算法的示例性流程图。
图36A-B示出了可以用于由数据记录器270捕获的数据的移动平均(running average)算法的输出,并且图36C示出了这样的示例性移动平均算法。移动平均算法可以采用各种形式,但是在一种实施方式中,其可以包括基于可具有用户定义大小的平均窗计算每个值或数据点的移动平均。平均窗可以用于确定数据值(该数据值例如表示压力值)的数量,这些数据值被一起求平均以获得每个移动平均值。当每个新数据点被收集到时,平均窗可以移动,从而移动平均值能够以与采样频率相同的频率更新。在一种实施方式中,具体时间点的移动平均值可以通过对在时间点之前发生且落在该时窗中的数据值求平均来计算,换句话说,向后查找移动平均。向后查找移动平均可以通过下面的方程式定义,其中RA是移动平均值,p是数据值,n是窗采样数:
在使用中,可以对每个收集到的数据值应用平均窗,并且可以计算出该时间点的移动平均。然后,移动平均值可以例如单独显示或与原始数据值一起显示。图36A示出了在压力数据上运行这样的算法的结果。图36A呈现了包括尚未求平均的原始数据值3602的曲线的图形3600。同样在图形3600上示出了表示在应用向后查找移动平均算法后原始数据的三条曲线3604、3606、3608。如图所示,曲线3604对应于用10秒平均窗算出的移动平均,曲线3606对应用30秒平均窗算出的移动平均,而曲线3608对应于用60秒平均窗算出的移动平均。
在另一种实施方式中,具体时间点的移动平均可以通过对移动平均窗中的数据值(包括在该时间点之前和之后的数据值)求平均来计算,也就是说中央移动平均法(centralized running averagemethod)。如果平均窗的一半在该时间点之前而平均窗的另一半在该时间点之后,则中央移动平均法可以由以下方程式定义,其中R4是移动平均值,p是数据值,n是窗采样数:
图36B示出了在压力值上运行这样的算法的结果。图形3620包括尚未求平均的原始数据值的曲线3622。同样在图形3620上示出了表示在应用中央移动平均算法后的原始数据的三条曲线3624、3626、3628。曲线3624对应于用10秒平均窗算出的移动平均,曲线3626对应用30秒平均窗算出的移动平均,而曲线3628对应于用60秒平均窗算出的移动平均。其他变形是可能的,其中平均窗不以待计算移动平均的时间点为中心,而是以一些其他比例围绕所述数据。例如,一时间点的移动平均计算可以基于平均窗中的数据值(其中该平均窗的四分之一在该时间点之前而该平均窗的四分之三在该时间点之后)进行。图36C显示了示出上述示例性的移动平均算法的示例性流程图。
在其他实施方式中,数据调制可以通过各种统计学和/或数学计算来执行,包括均方根计算、平均绝对偏差计算、用于形成(线性的和非线性的)拟合曲线的回归分析、峰值因素并且形状因数计算等等。这些方法可以如上述的移动平均计算法一样在参数数据值上进行。其他统计学和/或数学计算的使用可以根据具体应用进行选择。例如,在由限制装置22产生的数据参数(例如电压)具有负值和正值的实施方式中,均方根计算可能尤其有利。
移动平均值或者从调制计算获得的任何其他值的确定也可以触发各种警报或可以被记录成报告并由本地单元60、远程监测装置170和/或系统20保存。例如,如果移动平均落在预定范围中,超过或低于阈值,变得太快(例如其变化速度超过阈值)等等,可以产生警报或通知信号。替代地,这种事件的发生可以被记录或存储,以便包含在由本地单元60、远程监测装置170和/或系统20生成的报告或日志中。
在一些实施方式中,可以采用模拟滤波器作为数学处理参数数据的补充或替代。模拟滤波器库(或者这种滤波器的可选库)可以包括在用于去除干扰或不需要的频率信号的一个或多个装置。例如,在图35A-35E所示的实施方式中实现的调制和滤波可以通过适当的低通滤波进行移植。本领域技术人员应当理解,高通和带通滤波实施方式也是可能的并且取决于所需的结果。滤波器可以设置在各种位置,诸如注射端口36(例如,用作限制装置22的铜线链路的注射端口36)、本地单元60、远程监测装置170或信号通道中的其他装置。在一些实施方式中,将滤波器放置在植入物中可能是有利的,因为通过对信息进行预调制可以减少带宽和/或遥测发射(或接受)这样的数据所需的功率。另外,由于通过模拟过滤减少了数据的数量,在分析数据时可以减少对装置的数据分析要求。
数据处理算法也可以用于确定通过从限制装置22收集的数据表示的生理参数的基线水平。例如,由流体填充限制装置22感测的基线压力可以从收集的压力值确定。可以使用各种用于确定基线值的方法。但是,在通过图37A-B示出的一种示例性实施方式中,用于查找基线的算法可以涉及收集来自限制装置的数据(流程图37B的框3710)以及基于过去的数据值计算移动平均值(框3712)。在移动平均计算中使用的数据可以通过移动窗(例如在对其进行移动平均计算的时间点之前的平均窗,或者覆盖一定数量的数据值,例如至少10个值的平均窗)限定。在收集到每一个新数据值时,可以更新移动平均。如框3714所示,该算法可以确定是否已经通过将平均窗内的数据值与公差范围比较来估计基线值,以确定是否所有的值(或者,替代地这些值的一部分)在公差范围内,所述公差范围可以围绕移动平均值限定。如果是,则在框3716处,算法可以将该移动平均值作为参数的基线值。如果否,则在框3718处,附加的数据值可以被收集,这可以涉及定义新的平均窗或者收集规定数量的附加数据值。可以计算新的移动平均值,并且该过程不断重复直到找到基线值为止。本领域技术人员将理解,前述阈值、界限、时间、窗大小、或者其他变量的一些或全部可以由用户定义。在时间周期3706中测出的压力值的情况下,图37A示出了数据3700的曲线,该曲线示出了应用于收集大的数据的前述算法,图37A还示出了公差范围3700和平均窗3704。
在一些实施方式中,规定事件的发生可以启动算法以确定或搜索基线值。例如,在开始数据收集时,定时器终止时,或者在对限制装置22进行调节后(这可以涉及添加或减少流体),可能需要检查或确定是否存在新的基线值。图37C示出了压力数据在时间间隔中的曲线3720,由于向可填充流体的限制装置添加了大约7.5ml,故该曲线出现在基线漂移3722的上方。该调整可以触发执行诸如上述的基线确定算法,以新的基线值。
图38A-B示出了用于确定或预测参数的基线水平的另一种示例性算法。图38A示出了示例性的数据-时间曲线,以示出该算法在一组数据上的应用,图38B示出了示例性的流程图。在该实施方式中,算法通常可以涉及计算参数值的变化率何时变为零或大致近似于零以及此时的参数值是什么。为零或大致近似于零的变化率可以被当作表示已经达到基线值。更具体地,参照框3802、3804和图38B,算法可以包括收集在时间间隔中的参数数据,以及计算一时间点变化率或者在所述时间间隔内的时窗3820中的一组数据值(组A)的变化率。例如,变化率可以通过由限定的斜率计算来确定。参照框3806,算法还可以包括计算变化率自身的变化快慢,也就是变化率的变化速度。例如通过执行两次斜率计算(例如,窗3820中的组A和窗3822中的组B)并且随后计算斜率的变化,从而可以计算出变化率的变化速度。窗3820、3822可以通过时间限定或通过一组数据值限定,或者以适于选择一部分数据值的其他方式限定。例如:
Δ斜率=斜率B-斜率A
此外,变化率和变化率本身的变化快慢可以用于确定变化率何时将变为大约零以及那时的参数值是什么。例如,如框3808所示,变化率接近大约零(在该例子中表示已经达到基线值)所需的时间可以根据以下方程式进行预测:
使用参数值通过外推法可以计算出预测的基线值,并且该参数的大小不断变化直到基线时间,如下面的方程式所示:
基线值=基线时间×斜率B+组B中的参数值
本领域技术人员能够理解,前述方法可以广泛变化,而不脱离本文所述的技术的范围。例如,基线时间和基线值方程式可以是斜率A和周期A的抛物线(cast),以及可以使用多余两个数据窗,和/或可以改变数据窗3820、3822之间的间隔。而且,本领域技术人员能够理解,前述的方法可以在导数(例如,表示变化率)和二次导数(例如,表示变化率本身的变化速度)的概念上描述。
基线值的确定可以触发各种警报或者可以被记录下来,以供本地单元60、远程监测单元170和/或系统20作为报告保存。例如,如果压力超过或低于阈值(例如,对于规定的时间间隔),当基线压力发生波动时,当在规定时间后无法找到基线,当压力的变化率超过阈值,和/或当确定基线压力时,可以产生警报或通知信号。替代地,这样的时间的发生可以被记录或存储下来以便包括在由本地单元60、远程监测单元170和/或系统20生成的报告或日志中。另外,基线值可以与限制装置的状态(单独或者与其他数据结合的方式,如本文所述)相互关联。基线值可以指示过度拉紧、最优拉紧或未拉紧的限制装置,对于可填充流体的限制装置而言可以表示过度填充、最优填充或未填满的状态。例如,基线值超过预定阈值(例如被当成“过高”水平)可以指示限制装置过度填充或者过紧,基线值降到并且保持低于预定阈值(例如被当成“过低”水平)可以指示限制装置未填满或者过度松弛,等等。预定阈值可以使用患者的历史数据、组数据或者其他临床数据获得。同样,在一些实施方式中,压力的变化率(如上关于基线值确定所述的那样)可以与限制装置的状态相关。例如,变化率超过预定的变化率可以表示可填充流体的限制束带的过度填充,变化率低于另一个阈值可以表示限制束带未填满。
由数据记录器270收集的数据值可用于获得与戴有限制装置22的患者的生理参数有关的信息。例如,如前所述,数据记录器270可以收集表示由植入的限制装置22感测的压力(或者其他参数)的数据。关于生理参数(诸如心率、呼吸率以及其他)的信息可以从收集到的压力值(或者其他参数的值)确定。关于蠕动或吞咽事件(其可以自我表现为压力脉冲或压力脉冲序列)的信息也可以被确定,并且这样的信息可以包括这样的脉冲的数量、频率和持续时间。如图39A-B所示,多个频率可以存在于一组压力数据(或其他数据)中。如图39A所述,在图39A中表示由心跳引起的压力变化(心跳可以在限制装置22上施加可感觉到的力)的相对高频的脉冲3904可以叠加在(在图39A中表示吞咽时间的)低频脉冲3902上。图39B示出了心跳脉冲3906叠加在由呼吸引起的脉冲3908上。如图所示,呼吸脉冲大约每四秒发生一次。
在一种示例性实施方式中,可以分析压力数据的频谱。数据中的频率或多个频率可以被选择和识别为感兴趣的生理参数的频率,例如通过将该频率与指定为特定生理参数的可能范围的频率范围进行比较。生理参数的幅值或其他特征也可以通过以选定频率对数据进行提取或滤波来确定。各种技术可以用于分析和提取具有期望的频谱的信息。下面的例子参见图39A-C并且有时使用心率作为示例性的生理参数,但是本领域技术人员能够理解,各种周期性的生理参数可以被分析,并且不同于压力数据的数据可以被使用。
如图39C所示,一种示例性的算法可以涉及计算脉冲周期或者表示感测参数的数据值的变化。参照图3920,例如通过确定斜率何时变为或经过零,可以识别出数据的局部极大值或局部极小值。可以记录该点的时间(框3922),随后再次识别极大值或极小值(框2924)。该周期可以根据相邻极大值和/或极小值之间的时间来计算,并且该周期可以被检查,以检查其是否落在与重要的生理参数相关的可能频率的指定目标范围内。例如,心率可能与每分钟65至150下或周期的频率相关,或者与大约1.1至2.5Hz的频率相关。该范围可以通过装置限定,或者由用户限定。如果计算的频率落在该范围中,在框3926处,频率可以被识别或者指定为生理参数的频率。在一些实施方式中,算法可以包括比较极大值或极小值的大小以确保它们在彼此的公差范围内。参照39A可以看到,这样的方法能够时吞咽脉冲的极大值或峰值与心率脉冲的极大值或峰值不同。两者之间的区别可以确定在计算特定生理参数的频率中使用的适当极大值。在一些实施方式中,参数在极大值或极小值处的值也可以用于计算脉冲的幅值,并且该算法也可以包括将该幅值和预定的与生理参数相关的目标范围进行比较,以检查其是否落在该范围内。例如,心率可以具有大约7-8mmHg的幅值,如图39B所示,并且范围的大小可以包括至少7-8mmHg。本领域技术人员应当理解,上述的目标频率和幅值根据生理参数(需要寻找关于该生理参数的信息)变化。
如图39D所示,在另一种示例性的实施方式中,离散傅里叶变换(在很多情况下,通过快速傅里叶变换计算)可以应用在感测参数在时间间隔内记录的数据值上。因此,数据值可以从时域值变换至频域。数据值的频谱可以被检查,以识别存在于数据值中的频率或多个频率,所述数据值对应于与生理参数范围有关的频率范围。在一些实施方式中,频谱可以被检查,以识别存在并且超过量级阈值的一个或多个频率,所述频率对应于与生理参数有关的频率范围。如果多个频率存在于该范围中,具有最大量级的频率可以被选出,或者可以计算频率的加权平均并将其指定为生理参数的频率。幅值可以通过识别的频率的傅里叶系数给出。替代地,目标范围外的频率可以从数据去除(例如,通过将未选择的频率的傅里叶系数设定为零),并且通过执行傅里叶逆变换可以重建感测参数在时域中的值。时域中的数据值可以显示或进一步分析,例如通过比较极大值和极小值来分析幅值,等等。
图40A-C示出了能够提取出与来自限制装置22且通过数据记录器270收集的感测参数(例如压力)的值的生理参数有关的信息的另一种算法的输出,图40D示出了这样的算法的示例性流程图。在该示例性实施方式中,感测参数的值(诸如压力值4002)可以求平均以产生平均值4004。在很多实施方式中,通过对落在时间间隔的平均窗内的值求平均来计算所述平均,例如对每X秒的数据值求平均,或者计算预定数量的周围数据值(数据集)的平均值。平均窗的大小可以广泛变化,并且可以通过重要现象之间的关系得出。例如,如图40A所示,压力值以大约100Hz的频率收集,而吞咽事件可以以大约0.1Hz的频率发生,通过对落在平均窗4008内的每100个数据求平均可以计算和绘制平均值4004的曲线。可以从原始数据(例如该例子中的压力值4002)减去平均值4004,以便产生生理参数值4006,诸如表示心率、呼吸率等等的值。这些生理参数值4006可以被显示。另外,生理学值4006的频率、幅值、易变性或其他特征可以进一步被分析,例如使用一个或多个前述的算法。前述的平均-减法(average-and-subtract)技术可以在生理参数4006上(例如以较小的平均窗)重复进行,以便从中提取另一组生理学值(例如,可以从呼吸率值分开的脉冲值,然而呼吸率值可以从心率值分开)。
图40B示出了另一组示例性的压力值4010和从其计算出来的平均值4012。平均数据4012也可以用于分析生理学现象,诸如相对的低频现象和/或吞咽速率。图40C示出了可以通过求出示例性的压力值4010和平均值4012之间的差别来获得的生理学值。
图41A-C示出了另一种示例性的数据集,其示出了如何区分压力数据,以揭示与各种生理学响应有关的信息。如图41A所示,在时间间隔内收集的压力值4100可以用于检查由脉冲序列4102表示的吞咽事件或蠕动的总持续时间(例如,检查脉冲的幅值和数量),单个脉冲4104来自蠕动时间,和/或叠合的或小脉冲4106表示其他生理参数。图41B跟具体地示出了单个脉冲。如图所示,平滑曲线可以用于(通过计算平均值)分析脉冲4104的幅值、持续时间或其他特征。图41C示出了更具体地显示了小脉冲4106,如箭头4108所示,该小脉冲4106可被转化成线性的(例如通过上述方法的一种),以便测量频率、幅值或其他特征。
生理学速率、幅值或其他参数的确定可以触发各种警报或可以被记录下来,作为本地单元60、远程监测单元170和/或系统20保存的报告。例如,在心率或呼吸率(或其他速率)过高、过低、无法检测到、剧烈变化(例如,变化率超过阈值时)等时,可以产生警报或通知信号。替代地,这些时间或条件的发生可以被记录或存储下来,以便包括在由本地单元60、远程监测单元170和/或系统20生成的包括或日志中。
各种算法可以用于检测由数据记录器270收集的压力值或其他数据值的脉冲的出现。这样的算法的一种示例性实施方式在图42A-B中示出。图42A示出了压力值在时间间隔中的示例性的曲线4200,但是可以使用任何其他参数。图42B示出了表示算法的示例性步骤的流程图。如图所示,预定的阈值4202可以相对于基线值4212限定(图42B的框4222,4224)。(例如,阈值可以设置成高于基线值421210mmHg)。在框4226处,算法可以确定参数值超过阈值4204的时间4206。(因为阈值4202可以相对于基线值4202,是绝对值,所以参数至超过阈值4202的时间4206在参数超过基线值4212加上阈值4202时发生)。如果参数值下降从而在预定时间4210不再超过阈值4202,就可以说已经产生了脉冲(框4228-4230)。预定时间4210也可以由用户定义。
图43A示出了可以用于检测出现在一组数据中的脉冲的算法的替代实施方式的应用,图43B示出了这种算法的示例性的流程图。如图所示,第一阈值4302和第二阈值4304可以被限定(框4324a,4324b),两者相对于基线值4308限定,如相对于图42A-B所示的那样。当参数递增时(例如在脉冲的峰值之前)可以应用第一阈值4302,而在参数递减时(例如在峰值4312之后)可以应用第二阈值4304。在框4326处,算法可以确定参数值超过第一阈值4302的时间。如果参数值随后在预定时间4306降到第二阈值4304以下,这可以说发生了脉冲(框4328-4330)。
图44A示出了可以用于检测出现在一组数据中的脉冲的算法的另一种替代实施方式的应用,图44B示出了这种算法的示例性的流程图。在该实施方式中,第一阈值4402可以相对于基线值4408限定,而第二阈值4404可以相对于峰值4412限定(图44B中的框4424a,4424b)。参数超过第一阈值4402的时间和参数到达峰值(例如参数的斜率为零时)的时间可以被记录下来(框4426,4428a-b)。如果参数值在预定时间4406降到第二阈值4404以下,则可以说发生了脉冲(框4430,4432)。在很多实施方式中,第二阈值4404可以定位为峰值4412的比例(例如峰值的75%),当找出峰值4412时,算法随后可以计算出该第二阈值。在另一种实施方式中,第二阈值4404可以直接限定(例如比峰值4412低10mmHg)。
用于查找脉冲的算法也可以触发各种警报或者可以记录脉冲时间,以便由本地单元60、远程监测单元170和/或系统20保存报告。例如,在检测到脉冲时,当未检测到脉冲时,当脉冲在特定时间出现时(诸如在进食时间外),当脉冲计数超过阈值时,当在规定的时间内检测到脉冲时,当压力变化率指示脉冲开始或脉冲结束时,等等,可以产生警报或通知信号。替代地,这些事件的发生可以被记录或存储下来,以便包括在由本地单元60、远程监测单元170和/或系统20生成的包括或日志中。另外,确定发生了一个或多个脉冲可以与限制装置的状态(单独或者与其他数据结合的方式,如本文所述)相互关联。例如,如果在时间间隔内脉冲连续发生(例如,在预定时间间隔中,在一些情况下诸如5-6分钟的窗,但是其他时间间隔也是可能的),可以指示限制装置过度填充或者过紧。在该确定中,也可以使用或涉及脉冲的幅值和脉冲之间的时间(单独或者与其他量度结合),例如,可以考虑具有阈值幅值的脉冲。在其他实施方式中,脉冲数量序列或者在时间间隔内的脉冲数量可被用于建立互相关。同样,在预定时间间隔内没有脉冲出现可以指示限制装置过度松弛或这没充满。这样的脉冲分析还可以涉及给戴有限制束带的患者发出吞咽水/食物或干咽指示并且监测结果脉冲,以便确定观察脉冲的适当预定时间间隔,或者评估限制装置的状态,或相反。
脉冲或脉冲序列或参数-时间数据的其他波形的下方范围,可以用于分析目的。图45A示出了在时间间隔内压力的示例性曲线4500;图45B示出了用于做出这样的范围的示例性算法的流程图。如图所示,压力值通过图形表示4502(在这种情况下为波形)呈现,其展示了脉冲序列。一个或多个脉冲下方的范围可被评估。范围可以通过对窗(诸如时窗4512,4514,4516,4518)的每个脉冲进行积分评估来计算。该范围可以参照基线值4510或者零值计算。在很多实施方式中,窗的大小可以覆盖脉冲的时间,例如通过时窗在参数值超过阈值是开始并且在参数值降到阈值下时结束,或者通过使用结合图42-44描述的任何时间,诸如在图43B中所示的T2-T1或者在图44B中所示的峰值时间-T1。积分的结果可以进行比较,并且范围序列的属性(递增、递减等)及其大小可以与限制装置22、患者等的状态或与其有关的事件相互关联。例如,出现总体通过图45中的括号4506表示的具有基本相同范围的脉冲可以指示能够填充流体的限制装置被过度填充,或者一般来说限制装置过度拉紧。出现具有递减范围或者具有以预定速率递减的范围的脉冲(总体通过括号4508指示)可以指示束带被最优填充或者被调整好了。这样的范围以预定的第二速率(例如是比与最优填充的束带相关的速度更高的速度)递减可以与限制装置未填满相互关联。出现单个脉冲且后面没有任何峰值(总体通过括号4504指示)可以指示限制装置没有填满或者咳嗽或者说话。
应当理解,前述算法和技术的任何一种或全部可以与图形用户界面集成在一起,以便允许用户给算法提供输入并且允许显示中间结果和最终结果。例如,可以向用户展示压力-时间曲线,并且用户可以(例如通过手动地标记开始时间和结束时间)手动地定义或选择用于求平均、斜率计算或者用于计算脉冲范围的窗。在其他实施方式中,在观测压力值一定时间间隔后,用户可以通过调整屏幕显示上的水平线来手动地标记基线值。这样的变型也落在本公开的范围内。
应当理解,本文所述的多种实施方式可以使医护人员或他人将压力数据作为反馈机制,以便为患者识别、训练和/或出具膳食建议。这样的反馈机制可以提供数据或者以多种方式使用。例如,当患者吞咽特定食物部分时,可以获得压力反馈,根据该压力反馈可以教导患者进食更小部分、更大部分或者与测试的部分相等的部分。当然,通过评估在患者吞咽规定的食物部分时获得的压力反馈,可以对这样出具的食物部分进行测试,使得食物部分的处方可以通过复测法进行改进。作为另一个例子,患者可以根据压力反馈以及部分的尺寸和/或根据其他任何参数测试期望的食物的适当性。还应当理解,连续的压力数据监测可以用于实现部分的尺寸监测、食物一致性的监测(例如液体-固体)和/或进食频率的监测。本领域技术人员能够想到,压力数据可以以其他方式用于提供膳食建议。还应当理解,这些用法可以在本地、远程(例如经由远程单元170)或以本地和远程接合的方式实践。
虽然在本文中数据记录系统300被描述成与注射端口36一起被植入,但是应当理解,数据记录系统300可以替代地与其他任何适当的压力感测系统或其他植入系统一起被植入。仅仅作为例子,数据记录系统300可以与在以下文献中公开的压力感测装置中的任何一种结合,即:2006年3月7日提交、公开号为No.2006-0211914(申请序列号No.11/369,682)、题为“System and Method for DeterminingImplanted Device Positioning and Obtaining Pressure Data”的美国专利申请;和2006年3月6日提交、申请序列号No.11/682,459、题为“Pressure Sensors for Gastric Band and Adjacent Tissue”(代理文件号No.END6042USNP并且作为附件附加于此的美国非临时专利申请,这两篇专利文献的内容都通过引用结合入本文以便说明。例如,数据记录系统300可以接收由该专利申请中所述的任何一种压力传感器获得的压力测量结果。另外,该专利申请针中描述的针引导感测头可以与数据记录系统300的至少一部分一起使用,以给本地医生提供针引导,从而根据远程医生的指示调节流体压力,远程医生的指示基于由针引导感测头获得的压力测量结果并且以基本实时的方式传递给远程医生。例如,针引导感测头可以与数据记录器370连接,该数据记录器370可以与互联网直接连接或者通过对接站360连接,以便将压力测量结果提供给远程的医生。本领域技术人员能够想到,本文公考的装置和组成元件可以与美国专利公开文献US2006-0211912、US 2006-0211913和US 2006-0211914中描述的组成元件以其他方式结合,这些专利公开文献通过引用结合于此。
本领域技术人员能够想到,上述发明对不同类型的可植入束带具有相同的实用性。例如,束带被用于治疗大便失禁。一种这样的束带描述于美国专利No.6,461,292中,该专利文献通过引用结合于此。束带还可以用于治疗小便失禁。一种这样的束带描述于美国专利申请2003/0105385,该专利文献通过引用结合于此。束带还可以用于治疗心口灼烧和/或反酸。一种这样的束带描述于美国专利No.6,470,892中,该专利文献通过引用结合于此。束带还可以用于治疗阳痿。一种这样的束带描述于美国专利申请2003/0114729中,该专利文献通过引用结合于此。
本文所公开的任何装置也可以设计成在单次使用后丢弃,或者可以设计成多次使用。外部装置(诸如本地单元、远程监测装置、数据记录器等等)在很多情况下适合重复使用。装置可以在使用至少一次后进行修复或者改造以便再次使用。修复或改造可以包括以下步骤的任何组合:装置的拆卸,随后对特定件(包括机械部件、计算机硬件和软件等等)进行更换,升级,清理或者改进,然后重新组装。具体地,装置可以被拆卸,装置的任何数量的特定件或部件可以以任何组合方式选择性地被更换或拆除。该装置可在修复设备中或在即将对患者使用该装置之前由医生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、清洗和/或替换、和重新组装的各种技术。另外,可以对装置进行修理和/或对它们的单个部件或元件进行修理。这些技术的使用以及产生的修复好的、改造好的、或修理好的装置也全都在本申请的保护范围内。
优选地,本文公开的装置(尤其是包括但不限于那些可以植入患者体内或与患者连接的装置)可以在使用之前进行处理或消毒。首先,获取新的或者使用过的装置(或其部件)。然后可以对装置进行消毒。在一种消毒技术中,装置被放置在闭合且密封的容器中,诸如覆有塑料袋或高密度聚乙烯合成纸(TYVEK)袋。容器和装置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。消毒后的器械然后可被储存在无菌容器中。密封的容器保持器械处于无菌状态,直到其在医学场合下被打开。在其他实施方式中,环氧乙烷或蒸汽可以用于消毒。
虽然在本文中已经示出和描述了本发明的优选实施方式,但是本领域技术人员能够理解,这些实施方式仅仅是示意性的。在不脱离本发明范围的情况下,本领域技术人员能够想到各种变化、修改和替代。例如,如本领域技术人员可以想到的那样,本文的内容在机器人辅助的外科术中具有相同的应用。另外应当理解,上述的每种结构具有功能,这样的结构可以称为用于执行该功能的部件。因此,本发明仅仅通过后附的权利要求书的主旨和范围限定。
虽然已经通过多种实施方式的描述示出了本发明,但是申请人的并不希望将后附的权利要求书的主旨和范围限制或限定至这样的细节。在不脱离本发明范围的情况下,本领域技术人员能够想到各种其他变化、改变和替代。例如,已经在将压力数据从植入物传递到远程监测单元方面示出了本发明的装置和方法。但是其他类型的数据也可以被传递,以便医生能够监测限制性开口植入物的多个不同方面。另外,在用于肥胖症治疗的食物摄入限制装置方面描述了本发明。本发明不限于这些应用,并且还可以与其他限制性开口植入物或人造括约肌一起使用,这不脱离本发明的范围。与本发明有关的每个元件可以替代地作为用于提供由该元件执行的功能的措施加以描述。应当理解,以上描述仅仅是示例性的,并且在不脱离后附权利要求书的范围和主旨的情况下,本领域技术人员能够想到其他变化。
Claims (10)
1.一种获得关于生理参数的信息的方法,包括:
在一段时间内收集来自可植入的限制装置的数据,所收集的数据包含关于在所述一段时间内在体内所感测的参数值的信息;并且
在数据处理装置中,分析所述所收集的数据以确定所述一段时间的至少一部分的关于生理参数的信息。
2.根据权利要求1所述的方法,其中,来自体内的所感测的参数通过所述可植入的限制装置压力感测。
3.根据权利要求1所述的方法,其中,所述生理参数是下述中的至少一种:心率、呼吸速率、蠕动事件发生率、蠕动事件速率和基线参数值。
4.根据权利要求1所述的方法,其中,关于所述生理参数的所确定的信息是以下中的至少一项:频率、值、幅值、在所述一段时间内的至少一部分中值的改变,和在所述一段时间中的平均值。
5.根据权利要求1所述的方法,还包括利用所收集的数据来确定在所述一段时间内的至少一部分中关于第二生理参数的信息。
6.根据权利要求2所述的方法,还包括:
确定在所述一段时间内所述所感测的参数值中变化的频率量,并且将频率量中的一个或多个频率识别为所述生理参数的频率。
7.根据权利要求6所述的方法,其中,识别一个或多个频率包括将一个或多个频率与被指定为与所述生理参数相关的频率的一个或多个预定频率进行比较。
8.根据权利要求2所述的方法,其中,所述生理参数是生理事件的速率,并且使用所述所收集的数据包括:
确定在所述一段时间的至少一部分中压力值中变化的频率量;
选择在频率量中存在的一个或多个频率,其落入被指定为生理事件的可能速率的频率的预定范围内;并且
基于所述一个或多个所选择的频率识别所述生理事件的速率。
9.根据权利要求8所述的方法,其中,识别包括至少以下步骤中的一个:
(i)对所述一个或多个所选择的频率进行平均;并且
(ii)将所述一个或多个频率中的一个指定为所述速率。
10.根据权利要求8所述的方法,其中,确定所述频率量包括对所述所收集的数据的至少一部分进行傅里叶变换。
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BRPI0901428A2 (pt) | 2010-11-16 |
BRPI0901428B1 (pt) | 2020-03-24 |
EP2095798B1 (en) | 2018-09-19 |
BRPI0901428B8 (pt) | 2021-06-22 |
JP5595668B2 (ja) | 2014-09-24 |
JP2009207893A (ja) | 2009-09-17 |
RU2009107263A (ru) | 2010-09-10 |
US20090222065A1 (en) | 2009-09-03 |
CN101612036B (zh) | 2013-09-04 |
EP2095798A1 (en) | 2009-09-02 |
RU2501519C2 (ru) | 2013-12-20 |
US8152710B2 (en) | 2012-04-10 |
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