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CN101678156B - 具有带柱状突起的伤口接触表面的减压伤口敷料 - Google Patents

具有带柱状突起的伤口接触表面的减压伤口敷料 Download PDF

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CN101678156B
CN101678156B CN2008800154110A CN200880015411A CN101678156B CN 101678156 B CN101678156 B CN 101678156B CN 2008800154110 A CN2008800154110 A CN 2008800154110A CN 200880015411 A CN200880015411 A CN 200880015411A CN 101678156 B CN101678156 B CN 101678156B
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乔纳森·S·奥尔森
戴文·C·金泽尔
T·布莱恩·桑德斯
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Abstract

一种减压治疗系统包括分配歧管，分配歧管具有带有第一侧和第二侧的背衬基片以及定位在背衬基片的第一侧上的多个突起。突起中的每一个包括实质上圆形横截面形状并且具有在大约0.1毫米到2.0毫米之间的直径，该背衬基片其中形成有多个孔，以允许第一侧和与第一侧相对的第二侧之间的流体相通。减压源流体地连接到背衬基片的孔，以通过孔在突起之间传输减压，并传输到组织部位。

Description

具有带柱状突起的伤口接触表面的减压伤口敷料
发明领域
本发明一般涉及组织治疗系统，并且具体地涉及用于治疗伤口的分配歧管(distribution manifold)。
相关技术描述
临床研究和实践已经表明，在组织部位附近提供减压可增加和加速组织部位新组织的生长。此种现象的应用很多，但减压的应用在治疗伤口中已经特别成功。该治疗(在医疗机构经常被称为“负压伤口治疗”、“减压疗法”或“真空疗法”)能提供多种益处，包括更快愈合以及增加肉芽组织的形成。一般，通过多孔衬垫(porous pad)或其它歧管设备(manifoldingdevice)将减压施加到组织。该多孔衬垫包含小室或微孔，这些小室或微孔能够对组织以及从组织抽取的通道流体(channeling fluid)分配减压。该多孔衬垫经常被结合到具有促进治疗的其它部件的敷料。
用于传输减压治疗的分配歧管通常也被称为减压敷料(reducedpressure dressing)，或者在治疗伤口的情况中被称为伤口敷料。这些敷料的结构特征的特点是允许流体流过材料。例如，经常用作伤口敷料的一种材料是网状的开放小室聚氨基甲酸酯泡沫。该泡沫包括多个互相连接的微孔，这些微孔允许流体流过泡沫。当减压被施加到泡沫的一个区域时，此减压被快速地分配到泡沫的其他区域，并容易地传输到靠近泡沫的组织。关于开放小室泡沫以及类似材料的一个问题是组织长入，这限制了在治疗之后泡沫的容易移除。对于带有大小为约100-1000微米的微孔的开放小室泡沫，组织长入可能相对快速地发生。随着新组织进入泡沫的微孔或小室，该泡沫起到格子架(lattice)的作用，并且组织在微孔内以及形成微孔周边的壁的周围生长。这将泡沫有效地连接到组织部位，并且必须通过撕裂新组织并断裂已经形成在组织和泡沫之间的任何结合来强制地移除泡沫。这不仅对于愈合过程有害，而且撕裂该组织还可能引起患者不适。
规避组织长入问题的一种方法是增加更换敷料的频率。如果新敷料被更加频繁地施加，则会有较少的组织长入，并且因此在移除旧敷料时较少干扰新组织。增加敷料更换的一个消极面是增加与材料(即新敷料)相关的成本以及劳动力。更换敷料是劳动密集型的，并且会将医务人员的注意力从其它重要任务分散。增加的敷料更换也会引起患者以及他们的伤口更恶化。
概述
由现存的减压治疗系统带来的问题通过本文描述的说明性实施方式的系统和方法解决。在一个实施方式中，提供了一种减压治疗系统，并且该减压治疗系统包括分配歧管，该分配歧管包括背衬基片(backingsubstrate)以及定位在该背衬基片的第一侧上的多个突起，同时每个突起具有实质上圆形横截面形状，并且具有在大约0.1毫米到2.0毫米之间的直径。该背衬基片具有形成在其中的多个孔，以允许在第一侧以及与第一侧相对的第二侧之间的流体相通。减压源流体地连接到背衬基片的孔，以便通过孔在突起之间传输减压，并传输到组织部位。
在另一个实施方式中，提供了一种减压治疗系统，并且该减压治疗系统包括分配歧管，该分配歧管包括背衬基片以及定位在背衬基片的第一侧上的多个突起，每个突起具有实质上多边形横截面形状，并且具有在大约0.1毫米到2.0毫米之间的宽度。该背衬基片具有形成在其中的多个孔，以允许在第一侧以及与第一侧相对的第二侧之间的流体相通。减压源流体地连接到背衬基片的孔，以便通过孔在突起之间传输减压，并传输到组织部位。
在另一个实施方式中，提供了一种减压治疗系统，并且该减压治疗系统包括分配歧管，该分配歧管包括背衬基片以及定位在背衬基片的第一侧上的多个柱状空穴(columnar void)，每个柱状空穴具有实质上多边形横截面形状，并且具有在大约0.1毫米到2.0毫米之间的宽度。
在另一个实施方式中，提供了一种减压治疗系统，并且该减压治疗系统包括分配歧管，该分配歧管包括背衬基片以及定位在背衬基片的第一侧上的多个突起，每个突起具有实质上圆形横截面形状，并且从底部向内成锥度，突起在底部与背衬基片会合。该背衬基片具有形成在其中的多个孔，以允许在第一侧以及与第一侧相对的第二侧之间的流体相通。减压源流体地连接到背衬基片的孔，以便通过孔在突起之间传输减压，并传输到组织部位。
参照附图以及接下来的详细描述，说明性实施方式的其它目的、特征以及优势将变得明显。
附图简述
图1示出了依据本发明实施方式的减压治疗系统11。
图2示出了依据本发明实施方式的分配歧管。
图3示出了依据本发明实施方式的分配歧管的突起的形状。
图4示出了依据本发明实施方式的分配歧管的多个柱状空穴。
图5示出了依据本发明实施方式的分配歧管的多个柱状空穴。
图6示出了依据本发明实施方式的带有圆形突起的背衬基片。
图7示出了依据本发明实施方式的通过显微镜取得的分配歧管的照片的说明性复制品。
图8示出了依据本发明实施方式具有布置在背衬基片中的多个柱状空穴的示例性分配歧管的照片的说明性复制品。
说明性实施方式详述
在接下来的说明性实施方式的详细描述中，参照了形成说明性实施方式的一部分的附图。这些实施方式被充分详细地描述，以使本领域技术人员能实践本发明，并应理解，可以使用其他实施方式，并且可以做出逻辑结构、机械、电和化学改变，而不背离于本发明的精神或范围。为了避免对使本领域技术人员能够实践此处描述的实施方式来说不必要的细节，省略了对本领域技术人员熟知的某些信息的描述。因此，接下来的详细描述不应被理解为限制性意义，并且说明性实施方式的范围仅由所附权利要求界定。
提供了本文描述的本发明的若干实施方式以辅助伤口的愈合以及新组织的产生。减压治疗通过减压传输系统(reduced pressure deliverysystem)施加到患者。此种形式的先进的伤口愈合治疗(wound healingtherapy)可容易地结合到临床的伤口愈合程序。该治疗优化患者护理，并减少与具有外伤以及慢性伤口的患者的治疗关联的成本。通过本文描述的减压传输系统的创新性实施方式，可以在医院内、在社区环境比如辅助的生活配套(assisted living complexes)中以及疗养院中或者在家中实施减压治疗。
通过将传染性物质和其它流体从伤口或组织部位移除，传输到伤口或组织部位的减压能促进伤口愈合和/或组织生长。通过在组织上施加力，从而引起组织的微变形，减压治疗能进一步促进组织生长，而组织的微变形被认为有助于组织部位肉芽组织的发展。通过传输减压而施加到组织部位的力能进一步促进通向组织部位的血流的改进，这能进一步辅助新组织的生长。
参照图1，依据本发明实施方式的减压治疗系统11包括流体地连接到减压导管19的减压敷料或分配歧管15。该减压导管19流体地连接到减压源23，比如真空泵或另一抽吸源。分配歧管15贴靠着患者的组织部位31放置，并且用于分配由减压源23提供的减压。一般地，减压通过在分配歧管15和组织部位31上方放置不可渗透的或半渗透性覆盖物25而保持在组织部位。减压也起到从组织部位31抽取伤口流出物和其它流体的作用。罐27可以流体地连接到减压导管19并布置在分配歧管15和减压源23之间，以收集从组织部位31抽取的流体。分配转接器(distributionadapter)35可连接到减压导管19并定位在分配歧管15上，以辅助将减压分配到分配歧管15。
参照图2和图3，分配歧管15尤其是非常适合于促进组织部位31处的组织生长，但防止新组织长入分配歧管15内。该分配歧管15包括带有组织接触表面43的背衬基片41。该组织接触表面43优选地包括从背衬基片41伸出的多个伸出物或突起51。如在图3中更具体地示出的，突起51的形状可以为实质上圆柱形形状。可选择地，突起51的横截面形状可以为正方形、矩形、三角形、多边形、椭圆形或任何其它形状。突起51可以是逐渐变细的或者具有从头至尾均匀的横截面区域。
更具体地参照图3，突起51的高度H优选地在大约0.1到5.0毫米之间，并且更优选地为大约2毫米。每个突起的宽度W在大约0.1到2.0毫米之间，并且更优选地为大约0.25到0.5毫米。图3中示出的突起51的宽度等于其直径，因为每个突起51的横截面形状是圆形。如果突起51的横截面形状是正方形，则突起51的宽度等于正方形的边长。对于其他横截面形状，则宽度为穿过横截面的形心C的最长横向距离和穿过横截面的形心的最短横向距离的平均。每个突起51之间的横向的中心到中心间距E优选地在大约0.1到1.0毫米之间，并且更优选地为大约0.5毫米。突起51的间距产生分配通道61，减压可以穿过该分配通道61传输到组织部位31以及从组织部位31抽取流出物。突起51的高度大于突起51的宽度通常是优选的。更具体地，高度对宽度的比率H∶W应大于约1∶1，并更优选地大于约2∶1。
突起51的形状、尺寸和间距可以依据治疗的具体组织部位31、制造突起51和背衬基片41的材料类型以及施加到组织部位31的减压的量而变化。例如，对于高度流出性的组织部位，将突起定位成间隔地较远以保持突起51之间充分的分配通道61可能是有优势的。在本发明的一个实施方式中，对于具体的分配歧管15，突起51的形状、尺寸和间距是均匀的。在其它实施方式中，突起51的形状、尺寸和间距可以变化。例如，可以在背衬基片41上放置具有不同横截面形状的突起51。类似地，突起51的尺寸和间距可以变化，以便为组织部位31的选定部分提供较多或较少的减压。
突起51的存在及尺寸允许突起51对组织部位31分配减压，但防止在组织部位31上生长的新组织连接到分配歧管15的突起51。通过消除一般用于对组织部位传输减压的微孔或小室，新组织不能包裹形成微孔或小室的壁。虽然新生长的组织将生长到突起51的区域内并甚至可能包裹一些突起51，但是新组织不能够将其本身固定到突起51，因为每个突起的底部被锚固到背衬基片41。
除对组织部位31分配减压以外，分配歧管15还起到赋予组织部位31应力和应变的作用，这与那些传统上已经用在减压系统中的带有多孔状泡沫的分配歧管中见到的类似。有时候作为分配歧管用在减压系统中的其它材料，比如纱布，在组织上不具有此效果。由分配歧管15产生的应力和应变被认为将会引起存在的组织的微变形，并在组织部位处的新组织的产生中起到重要的作用。对组织部位有损害的应力和应变的量通过提供到组织部位的减压的量以及与组织部位接触的歧管的表面形态确定。当减压被施加时，组织部位的各部分贴靠着分配歧管15以及更具体地贴靠着突起51被拉动，这在组织内引起应力和应变的发展。在规模上类似于多孔状泡沫的微孔的尺寸的突起51的尺寸被认为是类似于在泡沫的使用中所见的应力和应变的发展的一个原因。
在一个实施方式中，背衬基片41由与突起51相同的材料形成。优选地，该材料为聚硅酮或另一种对于流体流相对不可渗透的医疗级材料。可选择地，该材料可以为半渗透性材料，其允许选择流体或经过的流体的量。背衬基片41可以包括多个孔71，该多个孔71允许从背衬基片41的与突起51相对的表面分配到突起51从其延伸的组织接触表面43。因为在组织长入方面，孔71的存在可能具有与微孔相同的效果，所以在任何新组织前进到孔71内之前，从组织部位31移除背衬基片41和突起51是重要的。在实践中，这可以通过了解组织生长的大致速度、突起51的高度并确定新组织生长到达孔71可能需要的时间量来完成。
虽然分配歧管15已经主要地被描述为包括背衬基片41和多个突起51，但是分配歧管15可以进一步包括邻近背衬基片41的与突起51相对的表面定位或连接到背衬基片41的与突起51相对的表面的多孔状泡沫或另一种材料。多孔状泡沫或其它材料的使用增加了减压导管19或分配转接器35对背衬基片41传输和分配减压的能力。突起51和背衬基片41起到对于新组织生长进入多孔状泡沫或其它材料的微孔的屏障的作用。
参照图4和图5，示出了依据本发明另一个实施方式的分配歧管115。代替多个突起，比如分配歧管15的那些突起，分配歧管115包括形成在背衬基片141内或以其它形式定位在背衬基片141内的多个柱状空穴151。术语柱状不意味着指任何具体的横截面形状，因为空穴的形状可以为先前参照突起51描述的任何形状。相反，术语柱状指的是一般长度大于宽度的空穴。空穴151本身产生多个分配通道161，这些分配通道161可以通过位于分配通道161的与组织部位相对的端部的主通道接合。可选择地，分配通道161可以简单地为完全地穿过背衬基片141的孔。
空穴151的形状和尺寸可以类似于歧管15的突起51的形状和尺寸。如先前描述的，多孔状泡沫、分配转接器或其它歧管装置可以被放置成与分配通道161流体相通以对组织部位传输减压。
具有突起的示例性分配歧管
参照图6和图7，已被测试并且已经示出了类似于多孔状泡沫的生长诱发速度的一种具体分配歧管215利用了两英寸直径的背衬基片241。该背衬基片包括大致上为圆形横截面形状并从底部向内逐渐变细的多个突起251，该突起在底部与背衬基片241会合。多个孔271设置在背衬基片241中，以允许与突起251之间的分配通道261流体相通。孔271被布置成定位在突起251的行和列之间的行和列。孔271以此种样式的定位引起一个孔271位于每四个邻近的突起251之间的中心，四个邻近的突起251被布置成正方形的样式(见图6)。
突起251的尺寸使得在两英寸直径的背衬基片241上存在大约7500个突起。每个突起在底部的宽度为大约0.5毫米，每个突起的高度为大约1.5毫米，并且突起之间的横向的中心到中心间距为大约0.75毫米。突起的高度对宽度的比率为大约3∶1，并且间距对宽度的比率为大约1.5∶1。每个突起251的锥度为从突起251的纵向轴线大约5度的脱模角度，以便辅助分配歧管215的模制。
分配歧管215的尺寸基于在更换分配歧管215之间组织生长的预期速度及想要的使用周期确定。对于约125毫米Hg的减压，预期在48小时的时间段内可能有1到2毫米的组织生长。因为希望每48小时更换分配歧管215，所以大约1.5毫米的突起高度允许在更换敷料之间突起251之间的大部分间距填充有新生长的组织，但防止组织连接到分配歧管251。
更具体地参照图7，提供了通过显微镜取得的分配歧管215的照片的说明性复制品。该照片示出了分配歧管215的俯视图，展示了从背衬基片241延伸的突起251。图7还示出了布置在突起251之间的孔271。
具有空穴的示例性分配歧管
参照图8，提供了具有布置在背衬基片341中的多个柱状空穴351的示例性分配歧管315的照片的说明性复制品。该背衬基片341为大约1.5毫米厚，并且每个空穴351的宽度(直径)为大约0.35毫米。因为空穴351延伸穿过背衬基片341，所以每个空穴351的高度为大约1.5毫米。空穴351之间横向的中心到中心间距为大约0.75毫米。空穴的高度对宽度的比率为大约4.3∶1，并且间距对宽度的比率为大约2.1∶1。
从前文应明白，已提供了具有显著优势的本发明。虽然本发明仅以它的一些形式展示，但本发明是不受限制的，而是可以做出各种改变和修改而不背离于本发明的精神。

Claims (18)

1.一种用于对组织部位传输减压的减压治疗系统，其包括：
分配歧管，其包括带有第一侧和第二侧的背衬基片以及定位在所述背衬基片的第一侧上的多个突起，所述突起中的每一个具有圆形横截面形状，并且具有高度和宽度，其中所述高度大于所述宽度，所述宽度在0.1毫米到2.0毫米之间，所述背衬基片具有形成于其中的多个孔，以允许在第一侧和与第一侧相对的第二侧之间的流体相通；以及
减压源，其流体地连接到所述背衬基片的孔，以通过孔在所述突起之间传输减压，并传输到组织部位；
其中所述突起防止新组织生长连接到所述分配歧管。
2.如权利要求1所述的减压治疗系统，其中，所述突起的横向的中心到中心间距在0.1毫米到0.5毫米之间。
3.如权利要求1所述的减压治疗系统，其中，所述突起的高度对宽度的比率为2∶1。
4.如权利要求1所述的减压治疗系统，其中，所述突起由医疗级聚硅酮制成。
5.一种用于对组织部位传输减压的减压治疗系统，其包括：
分配歧管，其包括带有第一侧和第二侧的背衬基片以及定位在所述背衬基片的第一侧上的多个突起，所述突起中的每一个具有多边形横截面形状，并且具有高度和宽度，其中所述高度大于所述宽度，所述宽度在0.1毫米到2.0毫米之间，所述背衬基片具有形成在所述突起之间的行和列的多个孔，以允许第一侧和与第一侧相对的第二侧之间的流体相通；以及
减压源，其流体地连接到所述背衬基片的孔，以通过孔在所述突起之间传输减压，并传输到组织部位；
其中所述突起防止新组织生长连接到所述分配歧管。
6.如权利要求5所述的减压治疗系统，其中，所述突起的横向的中心到中心间距在0.1毫米到0.5毫米之间。
7.如权利要求6所述的减压治疗系统，其中，所述突起的高度对宽度的比率为2∶1。
8.如权利要求5所述的减压治疗系统，其中，所述突起由医疗级聚硅酮制成。
9.一种用于对组织部位传输减压的减压治疗系统，其包括：
分配歧管，其包括背衬基片以及定位在所述背衬基片的一侧上的多个柱状空穴，所述柱状空穴中的每一个具有多边形横截面形状，并且具有长度和宽度，其中所述长度大于所述宽度，所述宽度在0.1毫米到2.0毫米之间；
其中所述柱状空穴防止新组织生长连接到所述分配歧管。
10.如权利要求9所述的减压治疗系统，其中：
所述柱状空穴产生多个分配通道，所述多个分配通道接合到位于所述分配通道的端部的主通道；以及
减压源，其流体地连接到所述背衬基片的分配通道，以将减压传输到组织部位。
11.如权利要求10所述的减压治疗系统，其还包括布置在所述背衬基片中的多个孔。
12.一种用于对组织部位传输减压的减压治疗系统，其包括：
分配歧管，其包括带有第一侧和第二侧的背衬基片以及定位在所述背衬基片的第一侧上的多个突起，每一个突起具有最接近于所述背衬基片的底部端部以及与底部端部相对的第二端部，所述突起中的至少一个突起具有圆柱形形状并向内逐渐变细，使得所述至少一个突起在底部端部处的宽度大于第二端部处的宽度，每一个突起具有3∶1的高度对宽度的比率，所述背衬基片具有形成于其中的多个孔，以允许第一侧和第二侧之间的流体相通；以及
减压源，其流体地连接到所述背衬基片的孔，以通过孔在所述突起之间传输减压，并传输到组织部位；
其中所述突起防止新组织生长连接到所述分配歧管。
13.如权利要求12所述的减压治疗系统，其中：
所述孔被布置成定位在所述突起之间的行和列；
所述孔被定位成使得一个孔位于每四个邻近的突起之间的中心，该四个邻近的突起被布置成正方形的样式。
14.如权利要求12所述的减压治疗系统，其中：
所述至少一个突起在底部端部的宽度为0.5毫米，
所述至少一个突起的高度为1.5毫米，且
所述突起之间横向的中心到中心间距为0.75毫米。
15.如权利要求12所述的减压治疗系统，其中：
所述突起的高度对宽度的比率为3∶1，且
所述突起的间距对宽度的比率为1.5∶1。
16.如权利要求12所述的减压治疗系统，其中，所述至少一个突起的锥度为从所述至少一个突起的纵向轴线5度的角度。
17.如权利要求12所述的减压治疗系统，其中，所述突起的尺寸使得7500个突起配合到具有两英寸直径的圆形背衬基片上。
18.如权利要求12所述的减压治疗系统，其中，所述突起由医疗级聚硅酮制成。
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JP5646584B2 (ja) 2014-12-24
CA2683175A1 (en) 2008-11-20
TWI393577B (zh) 2013-04-21
EP2144643A4 (en) 2018-01-03
ZA200907283B (en) 2010-07-28
TW200911313A (en) 2009-03-16
KR20120037514A (ko) 2012-04-19
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JP2012210424A (ja) 2012-11-01
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CN101678156A (zh) 2010-03-24
US9107989B2 (en) 2015-08-18
EP2144643B8 (en) 2020-12-30
US20080300555A1 (en) 2008-12-04
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JP2013081793A (ja) 2013-05-09
JP5469201B2 (ja) 2014-04-16
WO2008141228A1 (en) 2008-11-20
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