CN101511277B - 具有阻塞清除和双区压力保护能力的减压治疗系统 - Google Patents

具有阻塞清除和双区压力保护能力的减压治疗系统 Download PDF

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CN101511277B
CN101511277B CN200780033579XA CN200780033579A CN101511277B CN 101511277 B CN101511277 B CN 101511277B CN 200780033579X A CN200780033579X A CN 200780033579XA CN 200780033579 A CN200780033579 A CN 200780033579A CN 101511277 B CN101511277 B CN 101511277B
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CN101511277A (zh
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兰德尔·P·科尔奇
郑晓路
小鲁本·沃尔特·埃德加
乔纳森·P·贾伊伯
托马斯·保罗·罗洪
莎诺·C·英格拉姆
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Abstract

本发明提供了治疗组织部位的方法。该方法包括使用减压源将减压施加到组织部位上。监控减压源处的源压力，并测定源压力和期望的组织部位压力之间的压差。如果在减压源和组织部位之间存在阻塞，则将压差限制到第一最大压差。如果在减压源和组织部位之间不存在阻塞，将压差限制到第二最大压差。

Description

具有阻塞清除和双区压力保护能力的减压治疗系统
发明领域
本发明一般地涉及组织治疗设备，并具体地涉及具有阻塞清除和双区压力保护能力的减压治疗系统(reduced pressure treatment system)。 
相关技术的描述 
临床的研究和实践已经显示，在组织部位附近提供减压能增加并加速组织部位处的新组织的生长。此现象的应用很多，但减压的一个具体应用涉及治疗伤口。此治疗(在医学界中通常被称为“负压伤口疗法”、“减压疗法”、或“真空疗法”)提供了许多益处，包括在伤口部位处的上皮和皮下组织的移植、增加的血流和组织的微变形。这些益处共同导致肉芽组织的增加的发育和更快的治愈时间。 
虽然减压可极大地利于伤口护理和其中指示了增长的组织生长的其它例子，但施加到组织部位上的减压的量必须被控制以预防对组织的损害和过量流血的可能性。在提供减压治疗的系统中形成阻塞是普遍发生的。用于处理这些阻塞的常用方法涉及额外的负压的施加。此额外的负压可能对这些设备的安全使用带来风险。因此，存在对于减压治疗系统和方法的需要，该减压治疗系统和方法能够平衡减压的施加以促进组织生长，但仍然预防可对组织导致损害的减压的过度施加。 
发明内容
本发明的系统和方法解决了在控制组织治疗系统所施加的压力中存在的问题。在一个实施方式中，提供了包括与组织部位流体相连的减压源 的减压治疗系统。提供了与减压源相通以测量减压源处的源压力的感测设备。处理单元与感测设备相通，并且处理单元被配置为确定源压力和期望的组织部位压力之间的压差。处理单元进一步与减压源相通，以调节减压源所施加的源压力。调节压力以使：(a)如果在减压源和组织部位之间存在阻塞，则压差不超过第一最大压差，及(b)如果在减压源和组织部位之间不存在阻塞，则压差不超过第二最大压差。 
另外，减压治疗系统包括： 
罐，其流体地连接在所述组织部位和所述减压源之间；且 
其中所述感测设备测量所述罐处的源压力，以估计所述减压源的压力输出。 
另外，其中所述第二最大压差大于所述第一最大压差。 
另外，其中所述第一最大压差为约50mm Hg。 
另外，其中所述第二最大压差为约100mm Hg。 
另外，其中： 
当阻塞存在时，所述处理单元进一步被配置为在所述第一最大压差的限制内增加所述源压力，以清除所述阻塞。 
另外，减压治疗系统进一步包括： 
警报设备，其与所述处理单元相通，以在达到所述第一最大压差之后而阻塞仍不能被清除时警告用户。 
另外，其中所述处理单元被进一步配置为在所述第一最大压差和第二最大压差中的一个的限制内改变所述源压力，以使所述组织部位处的压力达到所述期望的组织部位压力。 
另外，其中所述处理单元被进一步配置为通过改变所述源压力并监控所述组织部位处的压力中的改变来检查阻塞的存在。 
根据本发明另一个实施方式，提供了治疗组织部位的方法。该方法包括使用减压源将减压施加到组织部位上。监控减压源处的源压力，并确定 源压力和期望的组织部位压力之间的压差。如果在减压源和组织部位之间存在阻塞，则将压差限制到第一最大压差。如果在减压源和组织部位之间不存在阻塞，则将压差限制到第二最大压差。 
另外，其中所述第二最大压差大于所述第一最大压差。 
另外，其中所述第一最大压差为约50mm Hg。 
另外，其中所述第二最大压差为约100mm Hg。 
另外，其中测定所述压差的所述步骤进一步包括监控所述压差。 
另外，所述方法进一步包括： 
当阻塞存在时，在所述第一最大压差的限制内增加所述源压力，以试图清除所述阻塞。 
另外，所述方法进一步包括： 
当阻塞存在时，在所述第一最大压差的限制内增加所述源压力，以试图清除所述阻塞；以及 
如果所述阻塞没有被清除，则产生警报以指示存在阻塞。 
另外，所述方法进一步包括： 
在所述第一最大压差和第二最大压差中的一个的限制内改变所述源压力，以使所述组织部位处的压力达到所述期望的组织部位压力。 
另外，所述方法进一步包括： 
通过改变所述源压力并监控所述组织部位处的压力中的方向性的相应改变，来确定阻塞是否存在；以及 
当所述组织部位处的压力没有出现方向性的相应改变时，确定阻塞存在。 
另外，其中改变所述源压力的所述步骤进一步包括增加所述源压力。 
在本发明的又一个实施方式中，减压治疗系统包括用于对组织部位施加减压的装置，以及用于监控用于施加减压的装置处的源压力的装置。系 统进一步包括用于测定源压力和期望的组织部位压力之间的压差的装置。提供了如果在组织部位和用于施加减压的装置之间存在阻塞就将压差限制到第一最大压差的装置。系统进一步包括如果在组织部位和用于施加减压的装置之间不存在阻塞就将压差限制到比第一最大压差高的第二最大压差的装置。 
参考下面的附图和详细描述，本发明的其它目的、特征和优点将变得明显。 
附图简述 
图1示出了根据本发明实施方式的具有减压治疗单元的减压治疗系统的示意图； 
图2描述了图1的减压治疗单元的结构图；以及 
图3示出了根据本发明实施方式治疗组织部位的示例性方法的流程图。 
具体实施方式的详细描述 
在优选实施方式的以下详细描述中，参考组成其一部分的附图，且其中作为例子显示了可实施本发明的具体优选实施方式。足够详细地描述了这些实施方式，以使本领域技术人员能够实施本发明，且应理解，可使用其它实施方式且可在不脱离本发明精神或范围的情况下进行逻辑、结构、机械、电子和化学改变。为了避免对本领域技术人员能够实施本发明所不必要的细节，本说明书可忽略对于本领域技术人员已知的某些信息。因此，不应在限制的意义上理解以下详细说明书，且本发明范围仅被附加的权利要求限定。 
如这里使用的术语“减压”一般指在受到治疗的组织部位处的小于环境压力的压力。在大多数情况下，此减压将小于患者所处于的大气压力。虽然术语“真空”和“负压”可用于描述施加到组织部位上的压力，施加到组织部位上的实际压力可显著地小于通常与绝对真空相关的压力。与该术语保持一致，在减压或真空压力中的增加指绝对压力的相对减少，而在减压或真空压力中的减少指绝对压力的相对增加。 
如这里使用的术语“组织部位”指位于任何组织上或在任何组织内的伤口或缺损，所述组织包括但不限于骨组织、脂肪组织、肌肉组织、皮肤组织、血管组织、结缔组织、软骨、腱或韧带。术语“组织部位”可进一步指不一定受伤或有缺损的任何组织的区域，而替代地为期望增加或促进额外组织的生长的区域。例如，可在某些组织区域中使用减压组织治疗以使可被获得并移植到另一组织位置的额外组织生长。 
参考图1，提供了根据本发明实施方式将减压传输到患者的组织部位102的减压治疗系统100。减压治疗系统100包括通过导管108与罐112流体相连的减压源104。罐112通过导管116与歧管适配器(manifoldadapter)120流体相连，歧管适配器120与分配歧管124接触并流体相连。分配歧管124被放置成与组织部位102相接触。消毒盖布128位于分配歧管124上，并优选地被密封到包围组织部位102周边的组织。歧管适配器120优选地通过消毒盖布128突出，且消毒盖布128被密封到歧管适配器 120。消毒盖布128可由不可渗透的或半渗透的材料制成，以协助维持组织部位102处的减压。 
分配歧管124主要负责将减压分配到组织部位102上，引导流出物和其它流体远离组织部位102，在组织部位102处引入微变形，并支持消毒盖布128，以产生减压被维持的空间。在实践中，分配歧管124通常为开孔泡沫，如网状聚氨基甲酸酯或聚乙烯醇泡沫。开口泡沫的尺寸被定为适应组织部位102，放置成与组织102接触，并随后当组织开始生长且组织部位102变得更小时定时地用较小片的泡沫更换。频繁更换开口泡沫对使组织进入泡沫的孔中的生长最小化是必要的。尽管普遍使用开口泡沫，许多可选的材料可作为可代替的分配歧管使用，包括能够提供分配特征的纱布和任何其它材料。相似地，不可更换的、可生物相容的材料可被用作分配歧管，并随后被允许保持在组织部位102处的适当位置。在大多数情况下，这些可生物相容的材料将作为用于新组织生长的支架(scaffold)而起作用，并且如果是可生物再吸收的，则将在治疗期间或之后被患者的身体吸收。 
减压治疗系统100进一步包括与组织部位102相通以测量组织部位102处的压力的第一感测设备132。第二感测设备136与减压源104相通以测量减压源104处的源压力。第一和第二感测设备132、136可为压力传感器或能够测定流体(即液体或气体)的压力的任何其它类型的传感器。第一和第二感测设备132、136可包括处理单元(未示出)以协助采集、解释、调节或传输数据。感测设备132、136和减压治疗系统100的流体部件之间的物理连接可根据所使用的感测设备132、136的类型而改变。相似地，只要期望压力或其近似值可被测定，每个感测设备132、136连接到减压治疗系统100的流体部件的物理位置可变化。第一感测设备132在图1中被示为在歧管适配器120附近与导管116物理相连。虽然这是一个可能的配置，但在另一个实施方式中，第一感测设备132为压力传感器，且通过导管116的测量腔与消毒盖布128下面的空间流体相连。通过提供多个在导管116中的腔(至少一个用于传输减压且至少一个用于测量组织部位压力)，第一感测设备132可位于离组织部位102很远的位置。第一 感测设备132可被放置在各种位置，只要被第一感测设备132测定的组织部位压力大体上接近组织部位102暴露于的压力即可。 
关于第二感测设备136，第二感测设备136可被连接于导管108(在图1中示出)或连接于罐112，以测定与被减压源104输出的减压一致的源压力。可选地，第二感测设备136可被放置成与减压源104的输出口相通，以直接测量减压源104产生的真空压力量。 
仍然参考图1，但也参考图2，减压源104和罐112可被包括在减压治疗单元140之内或安装在减压治疗单元140之上。治疗单元140也可包括第一和第二感测设备132、136以及执行软件214的处理单元210。处理单元210可配置有一个或多个相同或不同类型的处理器。例如，处理单元210可包括一个或多个处理器、逻辑组件、模拟组件或使信号能够被接收的任何其它电子设备，该信号包括信息，例如组织部位处的流体压力。 
处理单元210可进一步与下列部件相通：(i)用于储存数据和软件代码的存储器218，(ii)用于无线地、通过电线或通过存储器输入设备(未显示)与其它设备和系统，如阀或感测设备相通信的输入/输出(I/O)单元222，(iii)可储存一个或多个数据存藏器228a-228n(共同为228)，如具有一个或多个文件的数据库的存储单元226，(iv)可以或可以不为触敏的电子显示器232，及(v)能够使用音频、视觉或其它信号来给减压治疗单元140的用户发信号的警报器236。软件214可被配置为与其它设备(例如，电子显示器232)中的每一个通过界面连接，以允许管理和观察减压治疗。 
处理单元210与第一和第二感测设备132、136相通，以控制减压源104对减压的施加。在操作中，目标压力被指定(优选地被医生或其它被批准的医疗人员指定)，用于传输到组织部位102。目标压力为“期望的”减压，组织部位102应该暴露于所述“期望的”减压。期望的组织部位压力将在一个组织部位到另一组织部位之间变化，但一般将基于组成组织部位的组织的类型、损伤或伤口(如果有的话)的类型、患者的医疗状况和主治医师的偏好被选择。在选择了期望的组织部位压力之后，操作减压源104以在伤口处达到期望的组织部位压力。在许多情况下，由于压力在减 压源104和组织部位102之间损失，减压源104将需要在比期望的组织部位压力的减压更高的减压下(即较低绝对压力)操作。此外，流出物和其它流体在导管中的头压力(head pressure)可导致组织部位102处的真空压力降低。在图1中，罐112在组织部位102上面的高度H将确定被导管116中的流体施加在组织部位102上的头压力的量。对于具有与水相似的密度的流出物和流体，被一英尺流体施加的头压力约为25mm Hg。从组织部位流出的某些流体可比水更重或更有粘性，且因此在组织部位102处对压力损失有更显著的作用。 
作为一个由导管中的流体的重量导致的潜在损失的例子，对于特定组织部位的指定目标压力可为-125mm Hg。如果罐112被放置于在组织部位上方4英尺处，且如果罐112和组织部位102之间的导管116完全充满流体，则被那些流体施加的头压力可为约100mm Hg。如果组织部位位于患者的下端如足部，且罐112被安装于患者的头附近或之上(例如，当患者在轮椅中时，在IV静脉输液杆(pole)上)，则此具体的例子可能非常普遍。如果导管116中的流体的头压力为约100mm Hg，则可能需要施加约-225mm Hg的源压力以导致组织部位压力为-125mm Hg。 
可减少组织部位压力(相对源压力)的另一个因素为组织部位102和减压源104之间的导管阻塞。因为可能压力差至少部分地由阻塞导致，由减压源104(即源压力)提供的压力和期望的组织部位压力102之间的压力差对监控是重要的。如果阻塞存在，则尽可能快地清除阻塞明显很重要。阻塞阻碍了指定目标压力的施加，这导致治疗延迟和较慢的愈合。另一方面，如果阻塞两端的压差变得太大，通过对导管施加额外的压力来试图清除阻塞可能为危险的。当在高的减压(相对于组织部位)存在下阻塞清除时，此高的减压几乎同时传递到组织部位。在组织部位处额外减压的快速发动可导致对组织的损伤且引发过量出血。 
这里描述的减压治疗系统100提供针对由高负压导致的对组织部位102的损害的保护，同时提供在正常(无阻塞)条件下克服高头压力的能力。系统100使用“双区”方法，其中源压力和期望的组织部位压力之间的压力差被监控，并随后根据阻塞是否存在而与两个最大压差中的一个进 行比较。更具体地，如果对于组织部位102的期望的组织部位压力尚未满足，则减压源104处的源压力将被增加，并被第二感测设备136监控。随着源压力继续增加，测定源压力和期望的组织部位压力之间的压差。压差可在从第二感测设备136接收数据后由处理单元210计算。只要压差不超过第一最大压差，减压治疗系统100就试图达到组织部位102处的期望的组织部位压力。第一感测设备132继续监控组织部位102，以确定组织部位102处的压力是否达到期望的组织部位压力。 
不允许减压源无限地继续增加源压力。替代地，基于源压力和期望的组织部位压力之间的压差来限制源压力。在初始的“安全”或“绿区”操作中，压差将不被允许超过第一最大压差。已经发现，忽然清除阻塞可能会导致源压力被直接施加到伤口部位。因此，将绝对源压力限制到期望的组织部位压力以上的安全差是必要的。临床实践已经显示约50mm Hg是安全的压差量，且在一个实施方式中，第一最大压差被设置为约50mmHg。更具体地，对于大多数组织部位，同时改变约50mm Hg减压将不会对组织部位造成损害。在许多“阻塞”情况下，50mm Hg或更少的压差足以清除阻塞。然而，在阻塞不被此量的压差清除的情况下，减压治疗系统100将不允许仅仅为了清除阻塞而进一步增加减压。替代地，处理单元210传达指示阻塞的警报状况给警报器236，并继续在绿区参数(即压差不超过约50mm Hg)内施加减压。 
如果压差达到第一最大压差(即约50mm Hg)且目标压力仍然超过组织部位压力，则执行阻塞测试。当减压源104处的源压力中的改变不导致组织部位压力中的方向性的相应改变(directionally correspondingchange)时，在组织部位102和减压源104之间存在阻塞。如果方向性的相应改变确实出现在如第一感测设备132所指示的组织部位102处，则阻塞不存在。 
如果阻塞测试确定了阻塞不存在，且组织部位压力不等于期望的组织部位压力，则压力可被安全地增加，因为不存在额外的压力对组织部位的突然发动的风险。在此“红区”操作中，将不允许压差超过第二最大压差。在一个实施方式中，第二最大压差为约100mm Hg。提供红区操作参数， 用于当减压治疗系统100已经证实了在减压源104和组织部位102之间不存在阻塞时的情况。此操作模式在组织部位处的过量流体头压力导致组织部位压力比期望的组织部位压力低很多的情况下可能特别有用，而不管源压力的反复增加。 
虽然第一最大压差为50mm Hg及第二最大压差为100mm Hg是优选的，但这些压力值可根据被治疗的特定组织部位和个别的医学考虑因素而变化。虽然上文描述的压力保护系统为“双区”系统，可使用具有两个压力参数的多区系统以提供另外的保护应该是明显的。 
参考图3，根据本发明实施方式治疗组织部位的方法300包括在304监控减压源处的源压力，在308监控组织部位处的组织部位压力，并测定源压力和期望的组织部位压力之间的压差。如果在减压源和组织部位之间存在阻塞，则在316将压差限制到第一最大压差。如果减压源和组织部位之间不存在阻塞，则在320将压差限制到第二最大压差。 
从上文应该很明显，已经提供了具有重大优点的发明。虽然仅以它的一些形式显示了本发明，但本发明并不是仅仅限于而是允许不脱离其精神的各种改变和更改。 

Claims (19)

1.一种减压治疗系统，包括：
减压源，其与组织部位流体相连；
感测设备，其与所述减压源相通，以测量所述减压源处的源压力；以及
处理单元，其与所述感测设备相通，并被配置为测定所述源压力和期望的组织部位压力之间的压差，所述处理单元进一步与所述减压源相通，并调节所述减压源所施加的源压力，使得：(a)如果在所述减压源和所述组织部位之间存在阻塞，则所述压差不超过第一最大压差，及(b)如果在所述减压源和所述组织部位之间不存在阻塞，则所述压差不超过第二最大压差，其中所述第二最大压差大于所述第一最大压差。
2.根据权利要求1所述的系统，进一步包括：
罐，其流体地连接在所述组织部位和所述减压源之间；且
其中所述感测设备测量所述罐处的源压力，以估计所述减压源的压力输出。
3.根据权利要求1所述的系统，其中所述第一最大压差为约50mmHg。
4.根据权利要求1所述的系统，其中所述第二最大压差为约100mmHg。
5.根据权利要求1所述的系统，其中：
当阻塞存在时，所述处理单元进一步被配置为在所述第一最大压差的限制内增加所述源压力，以清除所述阻塞。
6.根据权利要求5所述的系统，进一步包括：
警报设备，其与所述处理单元相通，以在达到所述第一最大压差之后而阻塞仍不能被清除时警告用户。
7.根据权利要求1所述的系统，其中所述处理单元被进一步配置为在所述第一最大压差和第二最大压差中的一个的限制内改变所述源压力，以使组织部位处的压力达到期望的组织部位压力。
8.根据权利要求1所述的系统，其中所述处理单元被进一步配置为通过改变所述源压力并监控组织部位处的压力中的改变来检查阻塞的存在。
9.根据权利要求7所述的系统，其中所述处理单元当通过改变所述源压力而组织部位处的压力没有出现方向性的相应改变时，确定阻塞存在。
10.根据权利要求1所述的系统，进一步包括：
第二感测设备，所述第二感测设备监控所述组织部位，以确定所述组织部位处的压力是否达到期望的组织部位压力。
11.一种减压治疗系统，包括：
施加减压的装置，其用于对组织部位施加减压；
监控源压力的装置，其用于监控所述施加减压的装置处的源压力；
测定压差的装置，其用于测定源压力和期望的组织部位压力之间的压差；
将压差限制到第一最大压差的装置，其用于在组织部位和所述施加减压的装置之间存在阻塞的情况下，将所述压差限制到第一最大压差；以及
将压差限制到第二最大压差的装置，其用于在组织部位和所述施加减压的装置之间不存在阻塞的情况下，将所述压差限制到大于所述第一最大压差的第二最大压差。
12.根据权利要求11所述的系统，进一步包括：
罐，其流体地连接在所述组织部位和所述施加减压的装置之间；且
其中所述监控源压力的装置测量所述罐处的源压力，以估计所述施加减压的装置的压力输出。
13.根据权利要求11所述的系统，其中所述第一最大压差为约50mmHg。
14.根据权利要求11所述的系统，其中所述第二最大压差为约100mm Hg。
15.根据权利要求11所述的系统，其中：
当阻塞存在时，所述测定压差的装置进一步被配置为在所述第一最大压差的限制内增加所述源压力，以清除所述阻塞。
16.根据权利要求15所述的系统，进一步包括：
警报设备，其与所述测定压差的装置相通，以在达到所述第一最大压差之后而阻塞仍不能被清除时警告用户。
17.根据权利要求11所述的系统，其中所述测定压差的装置被进一步配置为在所述第一最大压差和第二最大压差中的一个的限制内改变所述源压力，以使组织部位处的压力达到期望的组织部位压力。
18.根据权利要求11所述的系统，其中所述测定压差的装置被进一步配置为通过改变所述源压力并监控组织部位处的压力中的改变来检查阻塞的存在。
19.根据权利要求18所述的系统，其中所述测定压差的装置当通过改变所述源压力而组织部位处的压力没有出现方向性的相应改变时，确定阻塞存在。
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