CN101677876B - 利用周期负压进行伤口治疗的仪器和方法 - Google Patents

利用周期负压进行伤口治疗的仪器和方法 Download PDF

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CN101677876B
CN101677876B CN200880007226.7A CN200880007226A CN101677876B CN 101677876 B CN101677876 B CN 101677876B CN 200880007226 A CN200880007226 A CN 200880007226A CN 101677876 B CN101677876 B CN 101677876B
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L·C·阿尔真塔
M·J·莫里夸斯
L·X·韦布
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
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Abstract

本发明提供一种组织治疗仪器和方法用于通过应用随时间变化的负压来治疗组织。该仪器包括适于覆盖伤口且适于保持所述伤口位置的负压的盖体。所述仪器还进一步包括抽吸源，该抽吸源被配置用于促使产生一个随时间变化的负压，该负压具有包含逐渐变化压力的周期性波形。所述抽吸源与所述盖体配合将所述盖体之下的随时间变化的负压提供给所述伤口。所述随时间变化的负压可变化于低于所述伤口组织固有的组织张力的第一个压力值和高于所述伤口组织固有的组织张力的第二压力值之间。

Description

利用周期负压进行伤口治疗的仪器和方法
【技术领域】
本发明一般涉及一种利用随时间变化的负压来治疗组织的仪器和方法，尤其但不完全地涉及一种利用正弦变化的负压来治疗伤口的仪器和方法。
【背景技术】
医药领域一直关注受损组织的治愈，如可能由疾病或外伤造成的受损组织。这些年来已采用了许多治疗方法，包括最近发展的通过利用负压的伤口治疗，其由Argenta和Morykwas博士开发并在美国专利5,645,081和5,636,643中阐明，也在公布的美国专利申请2003/0225347，2004/0039391，和2004/0122434中阐明，其内容纳入此处以作参考。虽然前述专利中所述的连续或间歇负压伤口疗法的应用同传统方法相比显示出愈合率有所提高，但是医疗的一项持久目标仍然是尽快治愈受伤或受损组织。因此，在医疗领域中仍然需要加快受损或受伤组织愈合的设备和技术。
【发明内容】
根据本发明，提供一种组织治疗仪器用于通过应用随时间变化的负压来治疗组织。可通过应用本发明治疗的组织包括受伤组织，如那些出现在慢性伤口、急性伤口、开放性伤口、封闭性伤口等等中的受伤组织。这样的伤口可由各种原因造成，如外伤、疾病、热伤(如烧伤或低温症)、手术并发症及其它因素。
为了将负压疗法应用于受损或受伤组织，本发明的仪器包括适于覆盖伤口且适于保持所述伤口位置的负压的盖体。所述盖体可方便地采用能够适合所述伤口周围组织的柔性的薄板或覆盖物的形式。或者，所述盖体可采用能够支撑自己不与待治疗的组织接触的刚性或半刚性结构的形式。所述仪器还包括密封件，所述密封件被配置用于使所述盖体密封于所述伤口的周围组织，如此以致所述密封的盖体在所述伤口之上提供一个可保持负压的室。可选择地，所述仪器可包括置于所述盖体和伤口之间的掩护物，以促进所述盖体下的负压分布和/或刺激所述伤口位置的组织生长。所述仪器还进一步包括抽吸源，所述抽吸源被配置用于促使产生一个随时间变化的负压，所述负压具有包含逐渐变化压力的周期性或其它变化的渐增和/或渐减的波形。所述抽吸源与所述盖体配合将所述盖体之下的随时间变化的负压提供给所述伤口。所述盖体和抽吸源之间的配合可采用通过端口与所述盖体相通的管的形式，以在所述盖体之下提供的周期性的随时间变化的负压。
本发明的另外一个方面，随时间变化的负压最好变化于低于所述伤口组织固有的组织张力的第一个压力值和高于所述伤口组织固有的组织张力的第二压力值之间。这样的变化可使所述伤口边缘严重变形，这可加快组织生长。例如，随时间变化的负压可具有低于大气压的25毫米汞柱的最小值和低于大气压的100毫米汞柱的最大值。
另外，本发明提供一种将负压应用到伤口的方法。所述方法包括用伤口盖体覆盖伤口，所述盖体被配置用于使得所述伤口位置保持负压。接着将所述盖体密封于所述伤口周围的组织以提供一个在所述伤口周围的所述盖体的下面保持负压的室。然后将所述盖体之下随时间变化的负压应用于所述伤口，其中所述负压具有包含逐渐变化压力的周期性或其它变化的渐增和/或渐减的波形。
【附图说明】
上述概要和下述对本发明优选实施例的详细说明将通过结合所附图示得到进一步的理解，其中：
图1按照图示说明的是本发明仪器的顶视图，其显示负压应用于仪器之前就在待治疗的伤口组织上的仪器；
图2A按照图示说明的是图1中仪器的侧视图，其中局部沿图1的线2A-2A剖开；
图2B按照图示说明的是图2A中仪器以及伤口表面和足以克服伤口组织固有的组织张力的负压应用于伤口组织之后向内朝着伤口中心取出的周围组织；
图3A-3D按照图示说明的是具有逐渐变化压力的本发明的循环变化的负压的波形，其中图3A显示正弦曲线波形，图3B显示三角形波形，图3C显示锯齿波形，以及图3D显示数字化正弦曲线波形；和
图3E按照图示说明的是具有正方形波形的间歇负压。
【具体实施例】
请参阅图示，其中相同的元件编号相同，一般由100标明的负压治疗仪器提供将包含逐渐变化的压力的负压应用到待治疗的组织，如图1所示。正如本文中所使用的，“逐渐”变化的压力指的是两个压力值之间的变化，这个变化是准连续的或连续的，即非即时的。特别地，包含逐渐变化压力的本发明的负压波形最好有一个周期的或循环变化的波形。例如，依照本发明逐渐变化的负压可能以正弦曲线波形310的形式提供，如图3A所示。具有逐渐或连续变化压力的本发明的其它代表性波形包括三角形波形320和锯齿波形330，其中每一个都包括斜升322，332和/或斜降324的压力，如图3B和3C所示。(为了是连续的，波形关于其第一和/或更高等级的衍生物不必是连续的，如图3B和3C所示，尽管它可能是连续的，例如图3A。)此外，如本文中所使用的，逐渐变化的压力的定义还包括一个准连续的波形，如数字化形式的波形，其具有持续逐渐变化的压力，例如数字化正弦波340，如图3D所示。对于包含逐渐变化的压力的数字化波形，在波形的最小和最大值之间数字化必须包括至少两个(且优选的是更多)阶跃。逐渐变化的压力不包括在波形的最小和最大压力之间只包含一个瞬间变化的压力波形，例如不包括正方形或长方形的波形360，如图3E所示。本文所使用的术语“间歇的”压力指的是正方形或长方形波形360，其中负压适用于应用362和非应用364的交替时期，即“开/关”压力。根据定义，间歇的压力不包括逐渐变化的压力。具有逐渐变化压力的负压，例如，一个正弦曲线波形310，当与连续的负压或间歇的负压360相比时其提供的是一个提高的治愈率。
为将逐渐变化的负压310，320，330，340实施到待治疗的组织，如伤口40，本发明的仪器包括一个置于伤口40上的盖体10，以使伤口40周围的环境可保持在负压下。一个可选的掩护物20可设置在盖体10之下，伤口40之上，以帮助伤口组织愈合。负压可通过管30在盖体10之下供给，管30的一端与盖体10之下的空间相通，另一端与抽吸源50相通。抽吸源50产生一个具有逐渐变化压力的负压，其最好具有周期性的波形。在这方面，抽吸源50可包括波形控制器60以产生一个负压波形。
现在更详细地参阅图示，图1按照图示说明的是应用到治疗位置90的本发明仪器100的示范性结构的顶视图，图2A按照图示说明的是图1中的仪器沿线2A-2A的局部剖面的侧视图。仪器100包括一个密封于待治疗的组织之上的盖体10，例如伤口40。适当的盖体10是一个适于医学应用并能在盖体10下的伤口40周围保持一个负压的元件。例如，盖体10可方便地采用自粘(或非粘)的形式，如柔性的聚合物薄板或外科用覆盖物。代表性的自粘覆盖物包括覆盖物(美国明尼苏达州圣保罗的3M公司)，覆盖物(美国佛罗里达州拉尔戈的Smith &Nephew)，等等。柔性的薄板或外科用覆盖物形式的盖体10可能特别适合在盖体10应符合治疗位置90的应用中使用。而且，柔性的薄板或覆盖物的使用可能特别适宜于依赖重量的位置。另外，提供一个自粘盖体10可简化盖体10到伤口40周围组织的应用并且可方便地允许盖体10连接和/或固定于仪器100的其它组成部分，该其它组成部分为盖体粘合剂接触的部分，如抽吸管30或可选的掩护物20。或者，盖体10可以是自立式刚性或半刚性材料，这可能特别适于不包括可选的掩护物20的仪器100的结构，如此以致盖体10不与伤口表面46接触。
为提供一个位于盖体10下且可保持负压的室，盖体10可利用粘合剂密封于伤口40周围的组织。例如，如果一个自粘的柔性的薄板或外科用覆盖物用作盖体10，粘合底布可固定于伤口40周围的组织以使伤口40周围密封。相反，如果使用的是一个非粘盖体10，单独应用的粘合剂或其它合适的材料可用于使盖体10固定于治疗位置90以在伤口40周围提供一个可保持负压的室。再进一步，对于刚性或半刚性的盖体10，密封可通过接触治疗位置90的盖体边缘和盖体10下负压的作用之间的配合加以提供从而创造盖体边缘和治疗位置90之间的密封接触。
一个可选的掩护物20可设置在盖体10和伤口表面46之间以提供各种功能，如防止盖体10接触伤口表面46，促进盖体10之下负压的平均分布，帮助液体抽离伤口表面46，刺激伤口表面46处的组织(例如，肉芽组织)生长，以及防止伤口40形成小腔。在这方面，掩护物可包括各种材料，如合成高分子材料、开室(Open-Cell)聚合体泡沫、非粘附材料、聚合体网状物、以及它们的组合。例如，组成和结构特性，如网状，关于掩护物20所提供的功能加以选择。举例来说，掩护物20的网状程度(或孔隙)可加以选择以阻止掩护物20内组织的生长。相反地，掩护物20的网状程度可加以选择以促进其中的组织生长，这可能特别适于掩护物20包含生物可吸收的材料的情形。
当掩护物20应用于待治疗的组织时，其可作为一个整体结构或一个不同组成部分的合成。可用来单独或与其它材料结合做掩护物20的代表性材料，包括V.A.C.和V.A.C敷料(美国德克萨斯州圣安东尼奥的Kinetic Concepts公司)，网状物(美国新泽西州新布朗斯维克)，等等。可用来单独或与其它材料结合做掩护物20的代表性非粘附材料，包括纱网(美国佛罗里达州拉尔戈的Smith & Nephew)，非粘附敷料(美国新泽西州新布朗斯维克)，等等。此外，非粘附材料可作为置于掩护物20之上或遍及整个掩护物20容积的覆盖层，如软膏、凝胶、天然或合成聚合物，或其它适合的材料。例如，无论是整体的掩护物20还是两部分组成的掩护物20，非粘附材料可作为泡沫掩护物20的一部分，在整体的掩护物20中其是构成掩护物20整体所必须的，在两部分组成的掩护物20中其与掩护物都是独立部分。而且，对于刚性或半刚性盖体10，可取的做法可能是使掩护物20张紧于伤口40上盖体10的开口之上，并且可选择地把掩护物20连接到盖体10以提供一个阻止组织生长进入盖体10的腔内的屏障。
掩护物20最好加以切割和成形以适应和填补伤口40。随着伤口40愈合并变小，掩护物20的大小可相应减小。掩护物20可通过与盖体10下面的黏性涂层表面12接触而固定在适当的位置，以帮助固定掩护物20于一个固定位置，并在盖体10被移除时帮助移除掩护物20。盖体10和掩护物20的一个特别方便的结构是柔性的自粘聚合物薄板或覆盖物与开室聚合体泡沫的组合。
负压到伤口40的供给可通过管30实现，或其它合适的结构，管30通过端口36与盖体10下的室气体相通。端口36可包括盖体10的一条边缘，在该边缘下有管30通过，如肠系膜，以与盖体10下的空间相通。或者，端口36可作为一个设置在盖体10的表面的开口、或接口、或其他合适的结构。设置在盖体10之下的管远端32可位于可选的掩护物20之上或之下或者嵌入掩护物20之内。除了在远端32设有一个开口，管30可沿着管30与盖体10下的室相通的部分设孔以沿着有孔的管30的部分供给负压。例如，管30可包括杰克逊-普拉特流失(Jackson-Pratt Drain)。
负压由抽吸源50通过管30提供给伤口40，管30在其近端34与抽吸源50气体相通。可能包括真空泵的抽吸源50，包括波形控制器60以控制由抽吸源50产生的压力波形随时间变化的特性，如此以致抽吸源50产生一个具有逐渐变化压力的随时间变化的负压(逐渐变化的负压)。具有逐渐变化压力的负压最好以周期或循环变化的波形的形式提供，该周期或循环变化的波形在至少一部分时间T内是连续的。例如，逐渐变化的负压可能采取的形式是正弦曲线波形310、三角形波形320、锯齿波形330、或数字化波形，如数字化正弦波340，分别如图3A-3D所示。
在特别的应用中，可能可取的是，最大负压P2和最小负压P1加以选择以导致严重的组织变形(例如，如图1所示，伤口边缘42的径向向内和向外运动44，45)。最小负压P1的定义是最接近大气压的压力，最大负压P2的定义是离大气压最远的压力(即更强的吸力或真空)。当负压在其最大和最小值P2，P1之间变化时，伤口边缘42可能分别收缩和放松。与不提供严重的变形和放松的负压应用相比，这种严重的收缩和放松可能会导致组织形成率提高。例如，如果最大负压P2大到足以促使伤口边缘收缩，伤口组织可能不会出现严重变形。同样，如果最小负压P1不够小到使伤口边缘42放松，伤口组织可能不会出现严重放松。
一个这样的对用于导致严重组织变形的最小和最大负压P1，P2的选择是跨越待治疗的组织或伤口40固有的组织张力的压力。(组织具有固有张力-如果一个切口使得伤口打开。固有的组织张力可通过组织被移除后的一个圆形缺损变形成一个椭圆形而观察到。人类的这些线的映射通常被称为‘兰格式线(Langer Lines)’。)如果最大负压P2足够大，那么最大负压P2可以提供一个径向向内的力，该力促使伤口边缘42的径向向内运动44。当这种径向向内运动44完成时，负压值在伤口组织固有的组织张力之上。当伤口边缘42由于负压的应用而向内收缩后，如果最小负压P1足够小(接近大气压)，伤口边缘42可以放松并接近其原来的位置。在这种情况下，随时间变化的负压可以说成是在伤口组织固有的组织张力之下的第一(最小)压力值P1和伤口组织固有的组织张力之上的第二(最大)压力值P2之间变化。因此，循环变化的负压可促使伤口边缘42产生相应的循环的径向向内和向外的运动44，45。
除了如上所述的仪器，本发明还提供一种将负压应用到伤口40的方法。该方法包括用伤口盖体10覆盖伤口40，盖体10的结构使得伤口40的位置保持负压，以及密封盖体10于伤口40周围的组织以提供一个位于伤口40周围盖体10之下且保持负压的室。该方法继续将盖体10下随时间变化的负压应用于伤口40，伤口40处的负压具有包含逐渐变化压力的周期性波形。逐渐变化的压力可能持续一部分周期性波形的时间，或者可能持续整个周期性波形的时间。此外，随时间变化的负压可能变化于伤口组织固有的组织张力之下的第一压力值和伤口组织固有的组织张力之上的第二压力值之间。
实施例1
一个初步研究在两只猪上实施以比较正弦波的负压和连续的负压、间歇的负压、和湿对湿的纱布敷料。获取猪并使其适应新的居住条件，为期一周。这些动物被运送到手术室并且将动物的后背剃毛并为手术做准备。第一个动物的脊柱(中线)上生成四个完全厚度的伤口，直径5厘米且延伸至覆盖脊柱和深背部肌肉的筋膜。第二个动物的脊柱的横向上产生二对伤口，即脊柱的每侧有两个伤口。一个治疗方案适用于每一个伤口：1)从低于大气压的50毫米汞柱到低于大气压的150毫米汞柱变化的正弦波负压；2)低于大气压的125毫米汞柱的连续负压；3)打开5分钟的低于大气压的125毫米汞柱和关闭2分钟(即没有负压)的间歇负压；和4)湿对湿纱布敷料。伤口的体积通过采取藻酸盐印模然后将塑件印模浸入装满水的有刻度的缸内进行测量。液体排出的体积等于缺陷的体积。
第一个动物七天后安乐死因为所有伤口被感染。第二个动物治疗了10天。值得注意的是在被感染之前用正弦波负压治疗的第一个动物，其伤口呈现‘灰色’，这或许是由于负压水平过高(即，远远低于大气压力)。用正弦波负压治疗的伤口生成新肉芽组织的速度快过用连续负压治疗的伤口，但慢过间歇负压治疗的伤口。所有三种负压应用促使的肉芽组织形成的速度都快过湿对湿纱布敷料的变化。同样值得注意的是在研究期间间歇负压治疗的伤口的边缘大体上随负压的应用和中止的每个循环运动。正弦波和连续的负压治疗的伤口的边缘大体上只在最初应用负压时运动。确定的是正弦波的振幅在低端是平坦的(即，最接近大气压的端部过大(大于固有的组织张力))。从这个初步研究中得出需要着手进一步的研究，其中正弦波负压水平应当在完全厚度的猪皮固有的组织张力的上下摆动。
为第二项研究做准备，进行一项测试以确定真空度和力的相互关系。10毫升的注射器垂直固定，其尖端在上，柱塞在下。一根管子连接到注射器的尖端，该管子的另一端连接到真空泵。柱塞被撤回。预定的负压水平被应用，其导致柱塞被拉进注射器的筒内。重量施加于柱塞直到柱塞停止运动。(增加的重量将拉动柱塞退出注射器的筒。)负压与施加的力是线性关系(F＝ma)。系统的静摩擦力通过将柱塞完全插入注射器的筒内然后施加重量直至柱塞开始向下运动进行测量。静摩擦力从测量中扣除以确定负压和力之间的关系。由此产生的力(牛顿，F)和负压(毫米汞柱，P)之间的关系，被认为是F＝0.0214 P-0.1372。根据Ksander等的一篇文章(1977年的《整形和修整外科》59(3)第398-406页)，幼猪背部(背面)的伤口大约需要50克力以大体上移除伤口的边缘(Ksander，图1)。因此，我们得出结论认为，低于大气压的30毫米汞柱将产生一个等于50克的力，这应是负压应当振动于其上下以产生严重的组织(并且因此是多孔的)变形的水平。
  动物   压力类型   最初的伤口体积(cc)   最终的伤口体积(cc)   从最初到最终经过的天数   填充率(cc/天)
  1   无(纱布)连续的间歇的正弦波   12141827   89719   7777   0.570.711.571.14
  2   无(纱布)连续的间歇的正弦波   98.5119   4222   10101010   0.50.650.90.7
表1
实施例2
六只25公斤的白色喂养猪被用作这个研究中的动物模型。每只猪在研究开始前适应环境一整周。首先，每个动物通过肌肉注射10毫升克他命、2毫升乙酰丙嗪和1毫升甲苯噻嗪鸡尾酒镇静下来。一旦镇静下来，猪被转移到动物手术室，将其剃毛，为手术做准备并用氟烷和氧气进行麻醉。在无菌条件下生成两个直径5厘米、圆形、全厚度的伤口，两伤口间距5厘米，伤口位于动物背部的中线，其向下延伸至深位置的背部肌肉。然后把海绵(美国德克萨斯州圣安东尼奥的KineticConcepts公司)切成两个直径5厘米的圆圈以适合两个伤口。排气管连接到各个海绵且整个面积用覆盖物(美国明尼苏达州圣保罗的3M公司)覆盖。接着把沉重的塑料挽具放到敷料之上，并把两件弹力织物T恤放到挽具之上，以稳固敷料和管。再让猪返回到其住处并且把一根排气管连接到V.A.C.该V.A.C.提供打开5分钟/关闭2分钟的间歇性正方形波的低于大气压的100毫米汞柱负压，并且把其它排气管连接到真空泵，该真空泵提供变化于低于大气压的25和100毫米汞柱负压之间的具有60秒周期的正弦波。受试对象错开，例如如果正方形波应用于前一个伤口，正弦波应用于后一个伤口，那么下一个受试对象将采用相反的应用，以控制伤口的解剖位置对伤口愈合的影响。
每日包扎伤口的变化和伤口体积的测量均通过使用Jeltrate酸盐(美国宾夕法尼亚州纽约的DENTSPLY国际)印模材料做伤口的印模来完成。体积通过100毫升量筒内的排水量进行测量。
来自六只25公斤白色喂养猪的数据显示，相比于正方形波间歇负压(平均比率为1.141cc/天)(p＝0.12)，正弦波负压(平均比率为1.354cc/天)下的肉芽组织形成率提高19％。如果这个数据与先前的研究比较推算，那么相比于标准的湿纱布敷裹于伤口，正弦波负压显示出肉芽组织形成加速大约122％。除了提供比间歇负压更高的愈合率，正弦波负压还减少与漏气相关的问题。正弦波负压考虑到防止漏气，这是因为负压是逐渐施加和除去的。而且，不同于间歇负压，泄漏可通过提供一个逐渐变化的压力来阻止，在压力变化的周期中该逐渐变化的压力不会返回到大气压。
  动物   压力类型   最初的伤口体积(cc)   最终的伤口体积(cc)   从最初到最终经过的天数   填充率(cc/天)
  1   间歇的正弦波   1010   00   1010   11
  2   间歇的正弦波   1212   61   88   0.751.375
  3   间歇的正弦波   1011   00   88   1.251.375
  4   间歇的正弦波   1713   42   99   1.4441.222
  5   间歇的正弦波   1316   00   109   1.31.778
  6   间歇的正弦波   1011   1.50   88   1.11.375
  平均   间歇的正弦波   1.1411.354
表2
从上述说明看来，本发明的这些及其它益处对于本领域的普通技术人员而言将是显而易见的。因此，本领域的普通技术人员将认识到在不背离本发明的主要发明构思的前提下可以针对上述实施例做出变更或修改。因此，应当认识到，本发明并不仅限于本文所描述的特定实施例，其目的是包括所有如权利要求所述的属于本发明范围和实质的变更和修改。

Claims (54)

1.一种将负压应用到伤口的仪器，其包括：
(a)网状掩护物，其被配置于刺激伤口处的组织生长且具有加以选择以阻止掩护物内组织生长的网状程度；
(b)盖体，其适于覆盖伤口和网状掩护物且提供伤口和网状掩护物之上的室且适于保持所述伤口位置的负压；及
(c)抽吸源，其被配置用于产生一个随时间变化的负压，所述负压具有包含逐渐变化的压力的周期性波形，所述抽吸源与所述盖体配合将所述随时间变化的负压持续足以在伤口处刺激组织生长的时间提供给所述室。
2.根据权利要求1所述的仪器，其中所述逐渐变化的压力持续至少一部分周期性波形时间。
3.根据权利要求1所述的仪器，其中所述逐渐变化的压力持续整个周期性波形时间。
4.根据权利要求1所述的仪器，其中所述随时间变化的负压具有低于大气压的最小值25毫米汞柱和低于大气压的最大值100毫米汞柱。
5.根据权利要求1所述的仪器，其中所述随时间变化的负压变化于低于所述伤口组织固有的组织张力的第一压力值和高于所述伤口组织固有的组织张力的第二压力值之间。
6.根据权利要求1所述的仪器，其中所述抽吸源被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的正弦曲线波形。
7.根据权利要求6所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
8.根据权利要求6所述的仪器，其中所述第一压力值低于所述伤口组织固有的组织张力，所述第二压力值高于所述伤口组织固有的组织张力。
9.根据权利要求1所述的仪器，其中所述抽吸源被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的三角形波形。
10.根据权利要求9所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
11.根据权利要求9所述的仪器，其中所述第一压力值低于所述伤口组织固有的组织张力，所述第二压力值高于所述伤口组织固有的组织张力。
12.根据权利要求1所述的仪器，其中所述抽吸源被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的锯齿波形。
13.根据权利要求12所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
14.根据权利要求12所述的仪器，其中所述第一压力值低于所述伤口组织固有的组织张力，所述第二压力值高于所述伤口组织固有的组织张力。
15.根据权利要求1所述的仪器，其中所述抽吸源包括真空泵。
16.根据权利要求1所述的仪器，其中所述盖体包括柔性的薄板。
17.根据权利要求1所述的仪器，其包括被配置成将所述盖体密封于所述伤口的周围组织的密封件，其中所述密封件包括位于面向所述伤口的薄板表面上的粘合剂以将所述薄板连接并密封于所述伤口的周围组织。
18.根据权利要求1所述的仪器，其中所述网状掩护物包括开室泡沫材料。
19.根据权利要求1所述的仪器，其中所述网状掩护物包括合成高分子材料。
20.根据权利要求1所述的仪器，其中所述网状掩护物包括非粘附材料。
21.根据权利要求1所述的仪器，其中所述网状掩护物包括聚合体网状物。
22.根据权利要求21所述的仪器，其中所述网状掩护物包括合成高分子材料。
23.根据权利要求22所述的仪器，其中所述网状掩护物包括软膏。
24.根据权利要求1所述的仪器，其中所述网状掩护物被配置用于促进与其接触的组织类型的形成。
25.根据权利要求1所述的仪器，其中所述网状掩护物被配置用于促进肉芽组织的形成。
26.根据权利要求1所述的仪器，其中所述仪器包括位于所述盖体处的端口，所述端口被配置用于使得所述负压传送至所述盖体之下。
27.根据权利要求26所述的仪器，其中所述端口包括与所述抽吸源气体相通的管。
28.根据权利要求27所述的仪器，其中所述管延伸至所述盖体的一边缘之下。
29.一种将负压应用到伤口的仪器，其包括：
(a)盖体，其适于覆盖伤口以在所述伤口之上提供一个可保持负压的室；
(b)设于所述盖体处的端口，所述端口被配置用于使得所述负压传送至所述盖体之下；和
(c)包括生物可吸收的材料的掩护物，用于放置在所述伤口处位于所述盖体和伤口之间；及
(d)真空装置，其与所述端口气体相通以在所述室内提供负压，所述真空装置被配置用于促使产生一个持续至少一部分周期的循环变化的负压，所述负压包含逐渐变化的压力，所述变化的范围从低于所述伤口组织固有的组织张力的第一压力值到高于所述伤口组织固有的组织张力的第二压力值。
30.根据权利要求29所述的仪器，其中所述逐渐变化的压力持续整个的循环变化负压的周期。
31.根据权利要求29所述的仪器，其中所述循环变化的负压具有低于大气压的最小值25毫米汞柱和低于大气压的最大值100毫米汞柱。
32.根据权利要求29所述的仪器，其中所述真空装置被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的正弦曲线波形。
33.根据权利要求32所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
34.根据权利要求29所述的仪器，其中所述真空装置被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的三角形波形。
35.根据权利要求34所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
36.根据权利要求29所述的仪器，其中所述真空装置被配置用于促使产生一个压力变化于低于大气压的第一压力值和低于大气压的第二压力值之间的锯齿波形。
37.根据权利要求36所述的仪器，其中所述第一压力值是低于大气压的25毫米汞柱，所述第二压力值是低于大气压的100毫米汞柱。
38.根据权利要求29所述的仪器，其中所述真空装置包括真空泵。
39.根据权利要求29所述的仪器，其中所述盖体包括柔性的自粘式薄板用以密封所述伤口周围的组织。
40.根据权利要求29所述的仪器，其中所述掩护物包括开室泡沫材料。
41.根据权利要求29所述的仪器，其中所述掩护物包括合成高分子材料。
42.根据权利要求29所述的仪器，其中所述掩护物包括非粘附材料。
43.根据权利要求29所述的仪器，其中所述掩护物包括聚合体网状物。
44.根据权利要求43所述的仪器，其中所述掩护物包括合成高分子材料。
45.根据权利要求44所述的仪器，其中所述掩护物包括软膏。
46.根据权利要求29所述的仪器，其中所述掩护物被配置用于促进与其接触的组织类型的形成。
47.根据权利要求29所述的仪器，其中所述掩护物被配置用于促进肉芽组织的形成。
48.根据权利要求29所述的仪器，其中所述掩护物被配置用于促进其中的组织生长。
49.根据权利要求29所述的仪器，其中所述掩护物被配置用于阻止其中的组织生长。
50.根据权利要求29所述的仪器，其中所述端口包括与所述真空装置气体相通的管。
51.根据权利要求50所述的仪器，其中所述管延伸至所述盖体的一边缘之下。
52.根据权利要求3，5，18-25，30，40-49中任一权利要求所述的仪器，其中所述逐渐变化的压力包括持续变化的压力。
53.根据权利要求3，5，18-25，30，40-49中任一权利要求所述的仪器，其中所述逐渐变化的压力包括数字化波形。
54.根据权利要求1所述的仪器，其中所述网状掩护物包括生物可吸收的材料。
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CN101677876A (zh) 2010-03-24
US20130030396A1 (en) 2013-01-31
WO2008086397A3 (en) 2008-10-16
JP2010515540A (ja) 2010-05-13
AU2008204903A1 (en) 2008-07-17
WO2008086397A2 (en) 2008-07-17
IL199715A (en) 2012-07-31
US8377016B2 (en) 2013-02-19
US9737455B2 (en) 2017-08-22
KR20100014770A (ko) 2010-02-11
EP2106255A4 (en) 2013-09-11
CA2674858A1 (en) 2008-07-17
US20080208147A1 (en) 2008-08-28
US20140155790A1 (en) 2014-06-05
IL199715A0 (en) 2010-04-15
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CA2674858C (en) 2015-09-15
JP2014111142A (ja) 2014-06-19
EP2106255A2 (en) 2009-10-07

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