CN103347561B - 用于评估伤口分泌液的集成系统 - Google Patents

用于评估伤口分泌液的集成系统 Download PDF

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CN103347561B
CN103347561B CN201180067100.0A CN201180067100A CN103347561B CN 103347561 B CN103347561 B CN 103347561B CN 201180067100 A CN201180067100 A CN 201180067100A CN 103347561 B CN103347561 B CN 103347561B
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L.托思
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Convatec Technologies Inc
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Abstract

描述了一种用于评估来自于患者的伤口的伤口分泌液的集成系统。该系统可包含用以探测、处理和报告各种伤口参数的功能。系统还可包括基于这些发现来作出治疗决定。系统可探测来自于患者的伤口的伤口分泌液的一个或多个生理值。系统可包括用于将一个或多个探测到的生理值与预定生理值相比较以便实时获得比较结果的器件。系统可包括处理器(15)，处理器(15)基于比较结果提供电子信号，其中电子信号可对应于用于治疗伤口(13)的方针。系统可与其它伤口治疗装置整体结合，如负压力伤口治疗装置(NPWT)(9)。

Description

用于评估伤口分泌液的集成系统
相关申请的交叉引用
本申请请求享有2010年12月8日提交的美国临时专利申请第61/421,003号的提交日期的权益，该申请的公开内容因此通过引用并入本文中。
背景技术
这里需要独立地监测和评估负压伤口治疗("NPWT")过程和提供在使用期间在患者中出现禁忌症的情况下中断NPWT治疗的机构。这里还进一步需要对NPWT装置的某些特征进行改进，如，安全性、功能性和智能、实时反馈。
用于评估伤口状态的当前治疗协议涉及经由看护人的定性分析。通常，看护人可通过看或闻分泌液或分泌液的总体外观的方式来评估伤口的状态。然而，看护人常常可能没有规律地或定量地评估伤口。例如，此类评估仅可以以每天或每周的间隔进行。该治疗协议的缺点在于评估以前的分泌液。在与伤口中的其原始状态相比时，这些分泌液的生理参数可随时间改变。颜色、微生物、氧和温度所有都随时间改变，所以每次在它们已经收集之后的分泌液的评估不是伤口状态的准确或可靠的预测。此外，分泌液的流动可为伤口评估中的有用工具。现有的评估技术可能未提供用于监测伤口分泌液流的可行解决方案。
发明内容
根据本发明的一个方面，一种用于评估来自于患者的伤口的伤口分泌液的系统可包括：包括伤口治疗装置的系统、用于探测伤口分泌液的一个或多个生理参数的一个或多个值的探测器件、用于分析一个或多个生理参数的值以便获得伤口分泌液的评估的分析器件，以及用于基于评估提供治疗方针的提供器件，其中伤口治疗装置、探测器件、分析器件和提供器件整体结合。
附图说明
图1为呈现根据本发明的实施例的伤口分泌液系统的构件的功能框图。
图2为根据本发明的实施例的整体结合在NPWT装置内的伤口分泌液系统的实施例。
图3为根据本发明的实施例的伤口评估过程的流程图。
图4绘出了根据本发明的实施例的伤口分泌液系统的截面视图。
图5绘出了根据本发明的实施例的包含多个光源和多个探测器的伤口分泌液系统的实施例。
图6绘出了根据本发明的实施例的包含流动扰乱元件的伤口分泌液系统。
图7绘出了根据本发明的实施例的包含具有生物标记涂层的流入特征的伤口分泌液系统。
图8绘出了根据本发明的实施例的构造成具有曲折通路的伤口引流管。
图9和图10绘出了根据本发明的实施例的用于夹紧伤口引流管线的伤口分泌液系统的实施例。
图11绘出了根据本发明的实施例的具有用于夹紧伤口引流管线的多个促动器的伤口分泌液系统。
图12绘出了根据本发明的实施例的具有沿伤口引流管线的相对侧设置的多个夹紧机构的伤口分泌液系统的备选实施例。
图13和图14绘出了根据本发明的实施例的分别包含在固定状态和释放状态中的弹簧加载的闩锁件的伤口分泌液系统的备选实施例。
图15和图16绘出了根据本发明的实施例的构造成具有分别在未应用状态和应用状态的电阻加热破坏元件的伤口分泌液系统。
图17绘出了根据本发明的实施例的包含具有设置在其上的压力传感器的薄膜的伤口分泌液系统的实施例。
图18绘出了根据本发明的实施例的包含热质传感器的伤口分泌液系统。
图19绘出了根据本发明的实施例的构造在收集室内的伤口分泌液系统。
图20绘出了示出根据本发明的实施例的不同光谱强度的图。
图21为根据本发明的实施例的用于伤口分泌液的光谱分析的过程的流程图。
图22为根据本发明的实施例的呈现伤口分泌液的光谱分析期间测量的波长范围的示例性二维矢量图。
图23为根据本发明的实施例的图22中的图的测量结果的光谱图。
图24为根据本发明的实施例的呈现伤口分泌液的光谱分析期间测量的波长范围的示例性三维矢量图。
图25示出了根据本发明的实施例的设置在辅助收集室内的伤口分泌液系统的备选实施例。
图26为示出根据本发明的实施例的用于获得伤口分泌液测量结果的流动测量结果的示例性过程的流程图。
图27为绘出根据本发明的实施例的流速测量结果的二维图。
图28为示出根据本发明的实施例的读取和评估循环过程中的步骤的流程图。
图29为示出根据本发明的实施例的用于获得伤口分泌液的读数的过程的流程图。
具体实施方式
本文公开了一种用于监测和评估伤口分泌液的系统、设备及方法。该系统和设备("伤口分泌液系统"或"系统")允许来自于伤口部位的伤口分泌液的便利评估，且可提供实时定量和预测功能，以及整体结合的连线诊断解决方案。另外，该系统可整体结合到伤口治疗装置中。
此外，还公开了一种用于收集生理数据且基于分泌液流速和其它特征的值的趋势来预测伤口愈合结果的系统及方法。
图1为根据本发明的伤口分泌液系统1的实施例的框图。在该实施例中，传感器或探测器11可探测和检索呈现伤口的状态的数据。该伤口数据可通过有线或无线器件17电子地传输至一个或多个处理器15。除其它外，处理器可基于伤口数据预测伤口状态和其它治疗解决方案。
可选的是，数据可储存在存储器16中。来自于处理器15的信息可通过本领域中已知的任何手段传输至输出装置19，以便通知或提醒使用者关于伤口的健康或状态。
图2绘出了伤口分泌液系统18的一个实施例。根据本发明的一个方面，系统18大体上与患者5的伤口3(和伤口分泌液)流体连通。系统18与伤口3之间的流体连通可经由本领域中已知的任何手段，例如，伤口引流器7，其为伤口治疗装置9的一部分。
伤口分泌液系统18可包括一个或多个传感器或探测器11，其可用于探测各种参数，包括但不限于温度、pH、颜色、粘性和色调。这些参数为当前伤口状态的有用的指示物，且可根据本发明的方面用于提出可行的治疗选择。
伤口分泌液系统可选为可使用一个或多个类型的光源13。 光源13可取决于其计划的功能来发射可变的光波长。光的波长可通过伤口分泌液发射，且可取决于分泌液自身的特征来改变。
然后，波长可由传感器或探测器11探测到。由传感器或探测器11探测到波长可呈现出分析的伤口分泌液的各种状态。传感器或探测器11可经由电子电路17将代表探测的波长的信息传输至整体结合在伤口分泌液系统18内的一个或多个处理器15。
一个或多个处理器15可适于接收探测到的波长数据，且通过程序过程来进行各种分析。处理器15可从传感器11接收波长数据，且在适合的过程中使用此类数据。过程的确定可为伤口健康或愈合的任何类型的诊断或分类，以及规定的治疗规程。包括但不限于历史数据、过程和矢量图的各种信息可储存在存储器16中。
过程的确定可无线地或通过有线手段传输来显示在机载显示器或外部显示器19上。如图2中所示，分泌液系统18可直接地整体结合到伤口治疗装置9中。在该构造中，处理器15可整体结合到伤口治疗装置中，且传感器、探测器和电路可与伤口引流器整体结合(伤口引流器为主动治疗装置的一部分)或与绷带或敷料整体结合。
系统18可探测血液在分泌液中的存在，以及监测和评估与伤口分泌液相关的其它生理值，如，流速/流量、颜色、细菌踪迹、温度、pH等。
图3为示出示例性伤口分泌液系统过程500的流程图。图3中的框代表伤口分泌液系统的各种功能，其可酌情组合、省略、添加或重新安排。
在框S501中，传感器探测和/或测量伤口分泌液的一个或多个参数。在框S501中获得的测量数据在框S503中传输至一个或多个处理器且由一个或多个处理器接收到。然后，处理器在框S505中分析接收的数据。基于分析的结果，可在框S507中作出关于经由传感器的测量结果的决定。可包括诊断或治疗方针的这些决定然后可经由警报或警告在框S509中输出，或在框S510中通过输出显示器输出。
集成结构
本文公开且附图中示出的伤口分泌液系统可包含各种结构特征。系统可不同地构造成用以附接到现有伤口治疗装置上，或可直接地整体结合到这些装置中的一者上。系统的结构还可包括用于光谱分析的光源，以及用于探测由这些光源发射的光的传感器或探测器。在光已经发射穿过伤口分泌液之后探测特定波长下的光可指出分泌液的某一参数的值。系统还可包括用于测量非光谱参数如温度和压力的传感器。
图4绘出了整体结合到现有伤口引流管线中的伤口分泌液系统28的实施例。系统包含用于将某一波长的光发射到分泌液中的光源29。该系统还包含探测器30，探测器30用于在光已经穿过伤口分泌液之后探测和/或感测光的发射波长。探测的波长的振幅代表分泌液的光谱属性，且可指出伤口状态。
此外，由图4绘出的实施例绘出了设置在伤口引流管线32的外部上的光学隔层31。光学隔层31用于避免环境光到达伤口分泌液。这提高了探测的准确度，因为其避免了可由除光源29发射的光之外的光引起的任何人为影响。
图5绘出了本发明的另一个备选实施例，其中系统可包含多频带光源，包括窄频带源33和宽频带源34。多个多频带探测器35也可设置在系统内。多频带源和探测器可用于探测光的各种波长，且因此探测分泌液的不同属性。探测器35可构造成用以除去不需要的环境光，且获得更完整的光谱信息。
在可适于用于在医院环境中使用的另一个实施例中，分泌液系统可整体结合在中心抽吸系统内。在此情况下，分泌液系统可与现有中心抽吸系统关联且与现有中心抽吸系统串联操作，以便在不利事件的情况下警告和停止从伤口部位的流动。在此情况下，分泌液系统可在不利事件的情况下夹住伤口引流管线。此类实施例可在医院环境中向现有NPWT装置提供安全且低成本的备选方案。该机构可用于防止由未探测到的出血造成的不慎的出血性危险。在此情况下，中心抽吸单元可预先构造成具有如本文所述的整体结合的伤口监测系统。
图6绘出了伤口分泌液系统的备选实施例，该系统包含与一个或多个探测器40和42和光源44组合的流动扰乱元件41。本实施例的布置可基于流动扰乱元件的偏转来提供更准确的感测。
在一个实施例中，分泌液系统可包括流体通道，分泌液可穿过该流体通道。在此情况下，如图6中所见，流体通道还可包括定位于分泌液的通路中的障碍物。当分泌液穿过障碍物时，在流动中造成了干扰。在干扰中和干扰周围的流动的行为可用于测量流动的参数，如粘性、浓度和/或固体物质的成分，等。流动中的干扰还可用于较好地混合分泌液，这可用于改善测量准确度。探测器40和42之间的任何信号变化可关于流动扰乱元件。粘性还可用于确定分泌液的总体含水率，以及大分子的存在。
如图8中所见，伤口分泌液系统可构造成具有布置在曲折通路60中的流动引流器。该构造可作用为从感测区域59消除环境光。
在本发明的另一个实施例中，如图8、图19和图25中所见，分泌液系统还可具有流动通路中的结构和有形的管，以确保分析下的流体不会在评估之前与之前收集的分泌液混合。
在又一个实施例中，分泌液系统可具有如图19中所示的室或捕集器98，流体可汇入室或捕集器98中，或流动以便协助获得关于分泌液的物理状态的更精确的测量结果。测量结果如流速可从汇集的流体、流动的流体或两者获得。该实施例可特别用于测量分泌液的热质。
如图19中所见，分泌液系统还可包括隔间，其由离开伤口部位的分泌液填充。在该实施例中，隔间可适用于隔离分泌液以用于分析或周期性地称量从伤口部位除去的分泌液，以便评估在一定时间内从伤口部位除去的流体的速率。隔间可包括用于在流体体积达到设定水平时排空的自动器件。作为备选，隔间可具有主动系统如阀，以在流体达到设定水平时排空隔间。
在该实施例中，分泌液系统可包括用以引导和/或中断经由伤口引流器流动的一个或多个阀。在又一个实施例中，分泌液系统可抽出流体来用于样本，而不会完全地中断经由流体管线的流动。如图19中指出的单独的流体在管线内分析，且允许在进一步的下游再混合。备选的设计可包括用于获得样本来分析的采样端口。
在备选实施例中，分泌液系统可沿罐的内表面或外表面整体结合，或布置成以便与罐匹配。在该实施例中，系统可布置成用以探测使用期间累积的分泌液的各种生理参数的值。在此情况下，系统可在分泌液累积在罐中时监测和探测分泌液的重量、高度、阻抗等。此类信息可对于确定是否已经出现不利事件如开始出血有价值。此类信息还可对于确定从伤口部位除去分泌液的总体速率有价值，因此提供了用于罐的变化的预测计划，或甚至评估从较高的分泌状态到较浅的分泌状态的伤口发展。
从伤口部位流动的分泌液的速率的变化可指出伤口状态中的变化。在另一个情况中，伤口分泌液的成分中的变化可指出伤口状态中的临床相关变化。分泌液除去速率中的此类变化还可用于确定如何最佳地从一种治疗变成另一种治疗。在一种情形中，从较高的分泌伤口相对变化至一个较浅的分泌伤口可用于监测。从较高分泌的伤口至较浅分泌的伤口的过渡可提供关于患者何时从更昂贵的治疗转至相对便宜的治疗的有用信息。昂贵的治疗的实例为NPWT，而低成本治疗的实例为湿伤口敷料或绷带。
分泌液系统可包括适用于确定伤口分泌液的以上性质的值的一个传感器或一系列传感器。
分泌液系统还可包括用于使得能够基于接触测量分泌液的一个或多个一次性传感器。此类传感器元件可包括布置成以便监测分泌液的一个或多个参数的值的声学元件、光声学元件、电化学元件、光学元件和/或阻抗光谱学元件。
一个或多个传感器可布置成以便经由敷料的外膜或经由伤口引流管线的壁来收集信息。传感器可为温度传感器、光学传感器、阻抗传感器、电化学传感器(例如，安培传感器)、电容传感器，等。
分泌液系统可包括本领域中已知的用于确定从伤口部位除去流体的量或速率的任何类型的流动传感器。流动传感器可为接触型或非接触型的。在非接触型流动传感器的情况下，传感器可为水平传感器、测压仪、流动进程计时器、微滴计算器、速度计等。在接触型流动传感器的情况下，传感器可为测压仪、压头监测器(如，压力计)、应变仪、涡轮、热质传感器、压力损失监测器、拖线等。
可以使用本发明的实施例来评估伤口分泌液的任何生理参数。相关的特定参数可包括伤口分泌液的流动、体积速率、pH、温度、血红蛋白浓度、颜色和色调。
在一个实施例中，例如，如图19和图25中所见，分泌液系统可通过测量收集室以其填充的速率来估计分泌液流速。在一个实施例中，如图19中所见，分泌液系统可包括测压仪与测量室的组合来测量流速，以及加速器，其用以监测测量室相对于垂直轴线的定向。来自于传感器的组合的信号可用于独立于分泌液系统的定向来确定来自于伤口部位的分泌液的正确流速。
在又一个实施例中，分泌液系统可具有如图19中所见的室或捕集器98，流体97可汇入室或捕集器98中，或流动以便协助获得关于分泌液的物理状态的更精确的测量结果。测量结果如流速可从汇集的流体、流动的流体或两者通过传感器101获得。该实施例可特别用于测量分泌液的热质。
如图19中所见，分泌液系统还可包括隔间98，其由离开伤口部位的分泌液填充。在该实施例中，隔间98可适用于隔离分泌液以用于分析或周期性地称量从伤口部位除去的分泌液，以便评估在一定时间内从伤口部位除去的流体的速率。隔间可包括用于在流体体积达到设定水平时排空的自动器件。作为备选，隔间可具有主动系统如阀99，以在流体97达到设定水平时排空隔间98。流体可经由入流管96进入隔间98中，且经由流出管103流出隔间98。
在该实施例中，分泌液系统可包括用以引导和/或中断经由伤口引流器的流动的一个或多个阀99。在又一个实施例中，分泌液系统可抽出流体来用于样本，而不会完全地中断经由流体管线的流动。如图19中指出的单独的流体在管线内分析，且允许在进一步的下游再混合。备选的设计可包括用于获得样本来分析的采样端口。
表1绘出了各种流速及其潜在临床指示。通过量化这些流速，且与本文所述的其它生理参数一起评估它们，可获得伤口健康的准确预测。
表1
分泌液体积 伤口状态 临床相关性
无 干伤口 干燥
不足 湿伤口组织(良好) 正常
有些 湿伤口组织 潜在浸渍
中等 饱和伤口组织 可能浸渍
很多 伤口组织浸在流体中 浸渍
流速实例
在本技术的一个实例中，收集罐使用图25中的实施例示出的构想建造成表现流动测量结果。图25为本发明的备选实施例，其绘出了伤口分泌液系统和设置在辅助收集室内的应变仪。此类测量结果可由一个或多个传感器获得，包括但不限于应变仪236、电容水平测量计244、光学测量元件242，以及电测量元件240。用于测量重量或水平的标准类型的测量计是本领域中公知的。例如，应变仪基于简单的电路，其中由重量的变化引起的机械应力引起元件的电阻与施加的重量成比例地变化。电容计读取两个点之间的不同的电容水平。在本技术中，室中的流体237(例如，伤口流体)的水平可具有与空气的电容值不同的电容值，所以可确定容器中的流体的水平。作为备选，光学测量计可使用光来确定两个点(例如，罐的顶部与流体)之间的距离，可指出流体237水平中的变化。
该特定实例中的系统可包括与较大的储槽232流体连通的小储槽230、给送到小储槽230的入口端口234。小储槽230利用柔性支承件238附接到较大的储槽232上。基于应变仪的测压仪236应用于柔性支承件，以便测量使用238期间支承件的弯曲。在研究期间，盐水用于模拟测量下的流体。系统还配备有电测量元件240、光学测量元件242、电容水平测量计244。因此，独立地或如果需要而组合地示范不同传感器类型的实例可用于确定流速。
在该实例中，少量流体经由入口给送，且传感器响应记录在计算机(PC)上。在注入流体期间，储槽经历混乱的干扰，以试图中断传感器读取。此类输入将为机动使用方案期间由装置经历的典型移动。响应数据使用有限脉冲响应和无限脉冲响应过滤器来过滤。过滤器用于除去移动的人为影响，且恢复来自于输入的可用信号。
大体上，由系统探测的信号关于小储槽的重量。这继而又关于流体进入容器中的流速的时间积分。因此，流速能够从储槽重量信号获取。
阀246在小储槽与大储槽之间使用，以便在其变得过满时排放和重置储槽。这种排空过程的流体动力可用于确定关于研究下的流体的粘性相关的信息。
图26绘出了进一步关于图19和图25中的流动测量的过程260。处理器260包括(1)在框S251中获得流动读数；(2)在框S252(1)中除去任何移动人为影响；以及(3)在框S253中基于本领域中已知的方法且尤其本文公开的那些方法来计算流速。如果计算的流速为可接受的，则将继续获得测量结果。如果流速为不可接受的，则在框S254中触发警报或警示。过程260中计算的流速还可映射在如图27中所见的图中。正如过程260，本文所述的沿流速图的各种值的光谱图可指出感染和/或出血的开始，即，262。
可由本文所述的方法或本领域中的普通技术人员已知的任何方法测量的分泌液流速是可靠的伤口健康预测因子。在本发明的某些实施例中，流速值和流速值的变化可通过各种手段探测到，且还可用于确定如何从一种治疗最佳地变化至另一种治疗。在一种情形中，从较高的分泌伤口相对变化至一个较浅的分泌伤口可用于监测。从较高分泌的伤口变至较浅分泌的伤口的过渡可提供关于患者何时从更昂贵的治疗转至相对便宜的治疗的有用信息。昂贵的治疗的实例为NPWT，而低成本治疗的实例为湿伤口敷料或绷带。在一种情形中，从伤口部位流动的分泌液的速率的变化可指出伤口状态中的变化。在另一种情形中，伤口分泌液的成分中的变化可指出伤口状态中的临床相关变化。
在另一个实施例中，装置内的一次性元件或管内的一次性电极的颜色评估可为可能的。还有可能将分泌液的颜色分布图映射至pH。若干荧光纳米颗粒系统可基于pH改变颜色。此外，共轭聚合物可用于做同样的事情(氧化还原电位将基于局部环境的pH而变化)。
此外，有可能具有与响应于局部pH变化的分泌液接触的颜色变化元件，以及可再使用的读取元件，其可通过监测颜色变化元件的颜色响应来分析pH变化。
温度可用于评估出血事件以及监测感染。芯层的血大体上比真皮中的间隙流体更暖。大体上，可构想出使用一次性金属元件来用于测量温度值的实施例，以及具有可再使用的探针的实施例。
在本发明的一个方面中，近红外光谱/可见光谱可用于探测存在于伤口分泌液中的血红蛋白的氧值。氧的存在可指出血红蛋白且因此血的存在。在本发明的方面中，这可触发指示器，或引起本文所述的一个夹紧机构夹住伤口引流管线来防止进一步出血。在又一些实施例中，该事件将向看护人提供适合的治疗方针。
色调和/或光度可用于描述分泌液的颜色。色调和/或光度的变化可指出伤口及其愈合阶段的生理状态中的变化。用于评估宽频带吸收光谱的量化系统还可用于评估分泌液的颜色和色调。
在一个实施例中，伤口系统可包括提供用于执行测量的很窄的波长的一个或多个激光二极管。在此情况下，光谱图和/或矢量可通过使用与多个激光二极管和/或一个或多个扫描激光二极管组合的单个探测器来生成。扫描激光二极管可通过由驱动电子装置产生的驱动信号的调制来产生调制的波长。进行此类调制用于简单除去由环境光干扰、移动等引起的人为影响。
用于定量实时光谱探测和评估的方法可为稳定的脉冲或调制近红外光谱或功能近红外光谱技术。其可使用多波长光谱等。在一个情况中，分泌液系统可包括与白光源组合的颜色分析系统。颜色分析系统可包括与一个或多个带通过滤器组合的一个或多个光电二极管，以便提供对光谱的节段的单独响应。来自于各个带的一个或多个输出将生成，其中各个输出提供矢量的光谱成分。如图22和图24中所见，输出矢量可映射至分泌液状态，从而产生出用于确定分泌物的状态的矢量图，且因此产生关于伤口的生理状态的报告。
图20为用于分析不同吸收波长的吸收图或色调图的一个实例。如图20中绘出那样，仅通过代表性的实例，二维图示出了沿蓝色104、黄色105、红色106和NIR107波长的源光谱108的吸收。该特定实例绘出了用于指出的颜色的宽频带探测。然而，在备选实施例中，还可使用单个宽频带探测器。吸收图中看到的特定值可变为伤口状态的特定评估。仅通过举例的方式，如果特定色调颜色达到某一水平，则由处理器执行的过程可编码来发出引流管线的警报或夹紧引流管线的信号。
图21绘出了执行成评估伤口分泌液的颜色或色调特征的各种操作的流程图。初始框S110可获得各种光谱成分。接下来，任何环境光可在框S112中除去，以提高来自于伤口分泌液的任何光谱读数的准确度。一旦框S112完成，则在框S114中从框S110获得的读数来计算色调矢量。色调矢量可通过本领域中已知的任何手段来计算。然而，在优选实施例中，矢量可使用以下等式计算：
等式 1
等式1为线性加权等式，其将传感器光谱的部分(各个部分由坐标Xi指出)计算到n次矢量空间中。光谱的各个部分由标量加权参数Ai来加权(仅在该实例中，更总体来说，加权参数可为更好将响应映射到矢量空间、调整主参数，以及调整环境条件中的变化的等式或算法)。
如本文公开的那样，等式中计算的关系可用于将读数从独立传感器、波长和/或光谱带映射到n维图中。该过程可完成，以基本上产生出输入响应映射到可量化的空间中，使得可更容易地从收集的输入信号获得诊断信息。所以，例如，至该n次空间的delta映射，其区域可具有与各种疾病状态、现有治疗的禁忌症等的统计上显著的关系。在患者数据落到图上的情况下通过关联，且检查历史数据和趋势数据，该技术可协助关于治疗决定来作出决定。
这些色调矢量然后与包含标准或可接受的色调值的色调图框S116相比较。在评估任何潜在问题的框S118中，来自于框S114的色调矢量与框S116中的可接受值相比较。如果那些值中的任何值不符合或超过来自框S116的可接受范围，则执行框S120中的预定动作。计划动作可包括从促动本文所述的一个闩锁机构来触动可听警报。
具体而言，光度和色调可指出伤口的感染、出血或增大浮肿，所有情况都需要紧急注意。本发明的某些实施例可与色调和光度的预定值比较和分析探测色调和光度值，以向患者或看护人提供有价值的治疗方针(见图22、图23和图24)。这些各种参数的值可组合到矢量图中。
图22为从伤口分泌液测量的基于给定光度201下的一定范围的颜色的二维矢量图200。如图23中所示，图200代表沿光谱图206的数据点。矢量图200的不同地点可指出与伤口状态相关的各种事件的可能性或实际出现。例如，在地点202处，可指出正常分泌液趋势，而地点203和204可分别指出可疑的出血或高出血概率。地点205可指出实际出血事件的存在。图23中的图206呈现出给定时间周期内的三个独立光谱分布图的线图。
图24为类似于图22中所示的二维图的三维矢量图，其基于从伤口分泌液测量的一定范围的颜色。变为矢量的伤口分泌液的光谱成分可映射在此类二维图或三维图中。通过增加颜色通道的数目，且因此增加能够探测到的波长的数目，可改善系统的灵敏度和准确度。沿矢量图的各种点，不论是二维图或三维图，都还可指出伤口健康的趋势。例如，曲线220可指出初始趋势，而曲线222可指出朝感染的轻微发展。曲线224可指出感染的实际开始，而曲线226可指出具有感染概率的各种区域。
矢量图中的给定点(例如227和228)可指出某一伤口状态。此类伤口状态可对应于预先规定的治疗方针。这些治疗方针可包括但不限于改变NPWT的环境，或关闭伤口引流器。细菌或其它感染的存在可需要将抗生素施予患者。
伤口分泌液的颜色光谱的定性分析可为用于评估伤口健康的另一个有价值的工具。表2绘出了各种分泌液、其颜色、透明度和可能的临床指示。
表2
分泌液类型 颜色、透明度 粘度 指示
浆状渗出液 清澈、稻草色 低粘度，水状 正常(良好)
纤维蛋白 浑浊 低粘度，线状 含有纤维蛋白
血清多血 清澈、粉色 低粘度，水状 正常(良好)
多血 红色 低粘度及水状 血管创伤
血清化脓 暗黄到奶油咖啡色 高粘度 感染
化脓 黄色、灰色、绿色 高粘度 存在炎症细胞、感染、化脓微生物
血化脓 暗色、红色 高粘度且有粘性 确定感染、存在中性白血球、细菌、炎症细胞，其中脉管破裂造成血泄漏
出血 红色 粘稠 创伤感染
实际上，当考虑遭受伤口的患者的诊断和治疗选择时，大体上，临床医生不需要大量的数据。期望分泌液评估系统分析从伤口探测到的值，且为关于使用者的治疗选择提供决定支持，而非仅数据呈现。为此，本发明的系统能够分析从传感器和/或探测器获得的数据的值。一旦进行分析，则系统可提供伤口的评估，以及治疗方针。
根据本发明的方法和设备的实施例可实时地探测各种参数的值，且执行如图28和图29中所示的分析过程。这些分析过程不但提供实时探测，这给出了伤口的更准确且可靠的评估，而且给出了实时治疗建议，因为它们评估伤口的当前状态，而不是已经位于收集罐中延长时间周期的分泌液。
分泌液系统可包括用以执行各种处理的处理构件，其提供或输出伤口状态情况或治疗选择，其除其它之外，可包括微电子电路如离散电路、微控制器、微处理器、ASIC、FPGA等，以调节和分析传感器数据来有意义地转译分泌液的生理参数。处理构件可整体结合地定位于系统内，以便传感器、光源和处理构件所有都容纳在相同的装置内。在备选实施例中，处理构件可定位成离系统的其它部分较远。
为了分析而执行的过程大体上为适应的，且可基于以下的一者或多者：平均单一相关评估器(AODE)、卡尔曼过滤器、马尔可夫模型、后向传播人工神经网络、贝叶斯网络、基底函数、支持向量机、k最近邻算法、基于案例的推理、决策树、高斯过程回归、信息模糊网络、回归分析、自组织图、逻辑回归、时间序列模型如自回归模型、移动平均模型、自回归集成移动平均模型、分级和回归树、多元自适应回归样条。传感器数据可从多个光源使用传感器融合途径来分析。特定过程可使用有监督学习、无监督学习和/或加强学习途径来演变。此外，装置可包括相关联的电源等，以驱动机载的电子装置(传感器、微电子电路、通信元件)。
当与温度读数、流速和NIR读数组合来分析色调和光度值时，可作出关于分泌液的实际状态的综合报告。通过将上文所述的过程应用于各种生理参数，包括色调、光度、温度和流动，则治疗方针的临床上适合的组可由系统输送，因此消除了对看护人或患者必须了解大量数据且作出主观决定的需要。
图28为用以获得和分析参数读数的示例性过程的流程图，以及呈现和显示了警告和治疗选择。
图28的过程也被称为读取和评估循环。伤口监测系统可在休眠状态下以节制或减少功率消耗。系统可在唤醒阶段S201期间响应于一些输入来"唤醒"。该输入可为任何类型的刺激，如动作，或计时器的结果。一旦唤醒，则系统将获得参数读数S203。在框S203之后，装置在框S222中立即回到待机状态。如果这是装置遵循的逻辑路径，则框S203中获得的读数也可储存在存储器中。
如果在框S203中获得读数之后，系统不会立即回到待机S222，装置可在框S205中得到调节和净化。如已经描述的那样，在从唤醒的第一模式中，装置可在环中，在该处，其简单地唤醒、获得读数、可能将其储存，且然后待机。如果替代重置，则装置需要切换模式来监测来自于框207的干扰，其将需要触动调节功能，这可在其中从207获得原始信号，且准备它们来用于分析(例如，取决于传感器类型或本领域中已知的其它形式的数据转换/信号调节来从模拟信号转变成数字信号)。还可能需要净化信号，因为许多信号可具有"噪音"或假的数据，这可需要在在209中处理之前滤出。
如果在框S203中获得读数之后，系统不会立即回到待机S222，装置可在框S205中得到调节和净化。该净化步骤有助于获得准确读数，且滤出任何无关的数据或人为影响。在框S205之后，框S203中获得的读数转变成矢量，且分配对应的权重S209。各种读数的加权可基于本领域中已知的任何因素。仅通过代表性实例的方式，可给予一个参数如温度高于pH的权重，或反之亦然。此类加权可从患者到患者变化，或应用于相同的患者。此类加权还可基于各种参数的历史权重来分配。一旦读数矢量化且加权，则框S213中的处理器将矢量化且加权的值与矢量图比较。在这点处，处理器分析数据，且基于矢量图上的矢量的地点作出关于值是否在框S217中的安全区域中的决定。构成安全区域的还有可预定和储存在与处理器相关联的存储器中的参数。如果在框S217A中确定读数在安全区域但看起来趋于朝向不安全区域，则那些读数的权重可在框S217(b)中调整来将较高优先级分配至所述值。接下来，基于调整的权重，系统作出关于是否值得警告使用者朝不安全区域的趋势的决定S217(c)。如果基于预定值，处理器确定实际上是否值得警告使用者，然后在框S217(d)中发出警告。如果不是，则系统在框S222中回到待机状态来最大限度减小功率消耗。
如果矢量化且加权的读数未在安全区域中，则处理器确定不安全读数是否是新出现框S219。如果这是新出现，则出现的警示权重在框S220中增大。一旦增大警示权重，则处理器回到待机状态S222。如果装置或处理器确定不安全读数不是新出现，则作出决定关于警示权重在框S219(b)是否是关键的。
如果警示权重不是关键的，则警示权重仅在框S220中增大，且装置回到待机状态S222。如果警示权重是关键的，则处理器在框S219(c)中确定值落入矢量图的哪个区域，且因此由读数的值指出什么类型的情况。基于框S219(c)处探测的事件的区域和类型，在框S219(d)处开始动作。动作可为警示、警报、伤口引流器的夹紧，或任何其它类型的事件或警告，这有助于使用者评估或处理伤口。如果在框S219(d)采取的动作解决，如框S219(e)中确定的那样，则装置和/或处理器在框S219(f)中记录事件，且回到待机S222。如果事件还没有解决，则框S219(d)处的动作将重复或维持。
在框S203处，在读取和评估循环，获得读数。图29为框S203中执行的操作的详细逻辑图。一旦处理器或装置"唤醒"，则传感器301通电。一旦传感器通电，则可获得参数值S303。如图29中所绘出的那样，探测和测量到参数，如伤口分泌液S303(a)的光谱成分、流动S303(b)、温度S303(c)、生物标记探测S303(d)和粘性(e)。尽管图29中示出了这些参数，但它们仅通过代表性实例的方式，且本发明可用于测量伤口分泌液中的任何参数。然后，这些值在框S305中转变成数字信号，这可作为低功率转换完成来降低功率要求。一旦已经数字化值，则处理器在框S309中执行对可为统计异常值的值的检查。
在框S309处，作为异常值分析的一部分，值可储存在存储器中来结合到历史数据S309(a)中。如果在框S311中确定样本为好样本，则处理器将执行特定校准S313来调整至特定的当前状态。一旦执行该调整，则框S315中的处理器可与步骤S207中类似地执行调节和净化。如果在框中由处理器确定样本不是好样本，则在框S311(a)中记录事件。如果坏样本为复发问题，其可由现有的历史值探测到，则在框311(c)将错误消息显示给使用者。如果问题样本不是复发的，则处理器回到待机S311(d)。
在处理器已经确定伤口状态和/或治疗信息之后，该数据可提供或传输至使用者或患者。如上文所述，系统能够传输和提供值和治疗方针给使用者。此外，系统还能够与负压伤口治疗装置直接连通，以便实现所需的变化。
系统包括用于警示患者或看护人存在异常的分泌液状态、量或情况的器件。在此情况下，其可包括一个或多个灯、显示器、扬声器、振动元件，或类似装置，以便将信息传输至患者或看护人。
装置还可包括无线通信能力，以便将关于伤口分泌液的相关信息输送至NPWT装置。此类信息可包括血液存在于分泌液中、存在细菌、分泌液的吸收光谱的变化、分泌液的流速的变化等。
伤口评估的结果可通过任何类型的图形用户界面、监视器或其它类型的显示器显示。伤口评估的结果还可通过如所见的指示器的使用来传送至临床医生和/或患者。指示器可为任何视觉指示器，如灯，或听觉指示器，如蜂鸣器或报警器，或感觉通信装置，如振动马达，以在已经探测特定事件时警示临床医生或患者。
分泌液系统可包括用于经由网络来通信的器件，如蜂窝网络、无线个人局域网络(WPAN)、宽域网络(WAN)、城市区域网络(MAN)、局域网络(LAN)、校园区域网络(CAN)、虚拟专用网络(VPN)、因特网、内部网或我附近区域网络(NAN)。
分泌液系统可布置为网络中的节点，因此以圆环、网格星、完全连接的线、树或总线网络拓扑来提供元件。在一个实施例中，分泌液系统传输相关的值，且作为网格或星形网络拓扑中的节点。
分泌液系统可包括用于与局部电信网络对接的器件，如，通过本地定位的移动手机、无线节点、无线调制调解器、电话适配器等的蜂窝网络。
分泌液系统可使用各种协议来经由网络传输相关信息，如，IrDA、Bluetooth、UWB、Z-WAVE、ANT或ZigBee。作为优选，相关信息经由低功率协议发送，如低能Blue tooth、ANT或ZigBee。
分泌液系统可包括整体结合的电力开关，使得一旦系统或与系统相关联的伤口装置定位成以便有效地评估分泌液，电力就自动地提供给机载的微型电路。在另一个实施例中，系统可包括用以从休眠唤醒系统自身或伤口装置的接近传感器。休眠功能可用于在非使用周期期间节制用电力。
在另一个实施例中，系统可包括具有如图7中所示的荧光生物标记的伤口敷料。生物标记50可用于探测各种状态。生物标记50可由外部定位的光学传感器52来评估，因此提供非接触方式来评估分泌液性质。光学传感器52可使用比色分析来读取生物标记50且探测生理参数的特定值的存在、不存在或量。在一个实施例中，可选的光源56可用于将光发射到伤口分泌液中。
在该特定实施例中，光学传感器52可定位于不透明或光学透明的管54的外表面上。生物标记可基于局部pH、局部阻抗、局部氧化还原电位、颜色变化，且可基于某些标准来发荧光，所有这些都是本领域中已知的。当它们与分泌液相互作用时，它们用于探测某些生物材料的存在或不存在。分泌液系统可通过光学器件(颜色变化、荧光等)或电气器件(pH、氧化还原作用、阻抗等)读取、探测或评估生物标记。
在又一个实施例中，该系统可探测感染的存在，包括但不限于抗甲氧苯青霉素金黄色葡萄球菌(MRSA)或抗万古霉素肠道球菌(VRE)，以警示在家的患者它们需要住院治疗。这些各种感染可通过评估整体结合到系统中的生物标记，或通过评估其它生理参数的值(包括但不限于温度)来探测到。
在一个优选实施例中，由系统执行的各个过程可以以无接触方式完成，使得传感器和支持传感器的电子装置不会与分泌液进行接触。这允许系统的构件再使用，因为避免了交叉感染，因此节约了必须在各次使用中使用可替换的传感器的花费。
非接触在本文中限定为不具有分析下的流体与感测元件之间的直接接触。引流管线中的薄膜可用于感测压力、温度等(见图17)。图18绘出了包含压力传感器的伤口分泌液系统的备选实施例。在本实施例中，伤口分泌液系统可包含邻近伤口引流器89的两个区段。那两个区域在图17中指定为系统与引流器的接口处的91和92，在该处，减小了系统的壁厚度。在系统与伤口引流器之间的精确接口处，薄膜设置在其上(未示出)。较薄的膜允许压力传感器探测地点91a和92a处的引流器内侧的压力。压力P1分配给地点91a处的压力读数，且第二压力P2从地点92a处的压力读数获得。例如，这两个压力读数之间的差异可用于确立流速、粘性。上文所述的构造可为整装在一次性支路内来用于置于现有的伤口引流管线上，或设计为伤口引流管线的整体结合的构件。
图18绘出了类似于如图17中所见的实施例。然而，图18中绘出的实施例测量相对于设置在凹口93和94中的各个中的微加热元件的热质。该实施例可用于估计沿伤口引流管线的壁的流速。
分泌液系统可包括在异常事件(如，分泌液中存在血液)中用于夹断或以其它方式闭合伤口引流管线的器件。在此情况下，装置可包括促动器，促动器可配置为以便在不利事件期间挤压管线。在另一种情况下，促动器可布置成使得其在正常操作期间有力地收缩，且在不利事件期间释放，因此夹下伤口引流管线且夹断流体流动。
图9至图16绘出了用于控制或停止从伤口的任何流体流动的各种控制机构。这些控制机构可包括夹住管线以在探测某一生理值时控制分泌液流动。这些夹紧机构也可在本文中称为闩锁件。不同类型的闩锁件可由不同机构触动。在一个机构中，闩锁件为活性材料元件，其将响应于刺激改变形状。适合的活性材料包括形状记忆合金、电活性聚合物、压电陶瓷等。在该特定实施例中，活性材料闩锁件设计成使得其在刺激时释放。
如果响应于某一参数值来用作NPWT系统的一部分，则系统可夹紧伤口引流管线以便在NPWT装置上造成故障(堵塞管线故障)。在此情况下，系统不需用具有其自身的器件，用于警示患者或看护人不利事件，而是可触发警报，其存在于现有的NPWT装置中来实现该目标。
在另一个实施例中，如图15中所见，适合的闩锁件设计成具有整体结合的电阻加热元件80、簧片81和可连结的紧固区域83。簧片在制造期间变形，且在变形状态中与可连结的紧固区域83连结。簧片还可连结到附接点84上，其中连结未被破坏。闩锁系统设计成使得流体在簧片保持在可连结区域上时流过相邻的通道，但当簧片释放87时，可使得流过流动管线85上的通道的流体堵塞。当加热该加热元件80时，可连结的紧固区域83熔化、变形或气化，引起变形的簧片与紧固区域83脱离。在此过程期间，如图16中所示，簧片桥接流体管线85，以防止流动且可选触发阻塞报警。其它备选闩锁件设计将对于本领域的技术人员清楚。
伤口引流器可具有特定的形状，除在不利事件如出血的情况下提供用于夹断伤口引流管线的促动器件之外，以便在抽吸期间保持分泌液的层流。该实施例中的代表性实例可在图9和图10中看到。存在于该实施例中的机械元件包括基于螺线管的夹阀65。正如传统的基于螺线管的设备，本实施例的夹阀65包含线圈磁铁66和线圈促动器磁铁67。在本实施例中，夹阀可促动以使伤口引流器69的内壁闭合或大致变窄。
伤口引流器的通道宽度的该变化有助于探测层流与湍流，且可限制流动来用于更好的分析或测量。图9中绘出的实施例可与本文所述的任何其它实施例组合，如，如图10中所示的流动扰乱元件70。当流动扰乱元件存在时，可通过光源62和探测器63发生沿分析流动区域64的分析和探测。
如图11中所见，一个以上的螺线管促动器71可用于加强夹紧效果。图12绘出了备选实施例，其中多个夹紧促动器73设置在伤口引流管线的相对侧上。图12中绘出的促动器73可响应于刺激如存在血液而被触动。在该事件中，促动器73被触动，且夹紧引流管线来防止进一步出血。警报74可发出堵塞流动管线的信号。
图13绘出了包含弹簧加载的可重置的闩锁件的本发明的又一个实施例。如图14中所示，在促动时，弹簧加载的闩锁件释放和引起机构在探测到一些不需要的事件如出血的情况下夹紧伤口引流管线79。如图13中所示，一旦被促动，则弹簧加载的元件75可重置，且闩锁件77可再固定。在该特定实施例中，操作所需的电子装置和电源可容纳在外壳上。
在常规的敷料或绷带的情况下，敷料构件可改变为以便与分泌液评估系统容易地整体结合。为了使得能够进行这种整体结合，敷料可具有电踪迹，如接口。电踪迹可使用导电墨水(Ag、AgCl、C、Ni等)印刷，或者通过本领域中已知的若干可用的RFID技术形成，且被嵌入来用于与分泌液评估系统电性地相互作用。
尽管已经参照特定实施例描述了本文的发明，当应当理解的是，这些实施例仅示出了本发明的原理和应用。因此，将理解的是，可对示出的实施例作出许多修改，且可设计出其它布置，这并未脱离由所附权利要求限定的本发明的精神和范围。

Claims (11)

1.一种用于评估来自于患者的伤口的伤口分泌液的系统，所述系统包括：
伤口治疗装置；
用于探测所述伤口分泌液的一个或多个生理参数的一个或多个值的探测器件；
用于分析所述一个或多个生理参数的值以便获得所述伤口分泌液的评估的分析器件，其中所述分析器件将所述一个或多个值转换成一个或多个矢量并且将所述一个或多个矢量与矢量图比较；以及
用于基于所述评估来提供治疗方针的提供器件；以及
其中所述伤口治疗装置、所述探测器件、所述分析器件和所述提供器件整体结合。
2.根据权利要求1所述的系统，其特征在于，所述伤口治疗装置为负压力伤口治疗装置。
3.根据权利要求2所述的系统，其特征在于，所述系统还包括使用所述治疗方针来控制所述负压力伤口治疗装置的控制器件。
4.根据权利要求1所述的系统，其特征在于，所述伤口治疗装置为敷料或绷带。
5.根据权利要求4所述的系统，其特征在于，所述敷料或绷带被改变以便与所述系统整体结合。
6.根据权利要求5所述的系统，其特征在于，所述敷料或所述绷带中的整体结合器件包括电子追踪器。
7.根据权利要求1所述的系统，其特征在于，所述提供器件可操作成用以将所述治疗方针传输至定位成远离所述系统的外部装置。
8.根据权利要求1所述的系统，其特征在于，所述一个或多个生理参数的值包括光度值。
9.根据权利要求1所述的系统，其特征在于，所述一个或多个生理参数的值包括色调值。
10.根据权利要求1所述的系统，其特征在于，所述探测器件、所述分析器件和所述提供器件布置成与所述伤口分泌液隔离开。
11.一种用于评估来自于患者的伤口的伤口分泌液的系统，所述系统包括：
伤口治疗装置；
用以探测或感测所述伤口分泌液的一个或多个生理参数的一个或多个值的传感器或探测器；
处理器，其用以将所述一个或多个值转换成一个或多个矢量并且分析所述一个或多个矢量，以便获得所述伤口分泌液的评估且基于所述评估提供治疗方针；以及
其中所述伤口治疗装置、所述传感器或探测器，以及所述处理器整体结合。
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US10207031B2 (en) 2019-02-19
CN103347561A (zh) 2013-10-09
CA2819475A1 (en) 2012-06-14
EP2648793A4 (en) 2014-09-17
JP6306082B2 (ja) 2018-04-04
EP2648793A1 (en) 2013-10-16
US11116884B2 (en) 2021-09-14
US20210369937A1 (en) 2021-12-02
WO2012078781A1 (en) 2012-06-14
JP5965409B2 (ja) 2016-08-03
US20140058344A1 (en) 2014-02-27
JP2016182343A (ja) 2016-10-20
EP2648793B1 (en) 2020-03-11
US20190134280A1 (en) 2019-05-09
CA2819475C (en) 2019-02-12
US20210369938A1 (en) 2021-12-02

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