CN106974683B - 负压伤口闭合装置 - Google Patents

负压伤口闭合装置 Download PDF

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CN106974683B
CN106974683B CN201610912564.1A CN201610912564A CN106974683B CN 106974683 B CN106974683 B CN 106974683B CN 201610912564 A CN201610912564 A CN 201610912564A CN 106974683 B CN106974683 B CN 106974683B
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R.M.邓恩
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Abstract

本发明涉及一种负压伤口闭合***和用于这类***的方法。本发明的优选实施方案通过优先收缩帮助伤口闭合而提供组织移动。优选实施方案可利用组织抓取元件以将伤口闭合力施加至组织。

Description

负压伤口闭合装置
本申请是申请号为201280017448.3、申请日为2012年2月3日、名称为“负压伤口闭合装置”的专利申请的分案申请。
相关申请的交叉引用
本申请主张2011年2月4日提交的美国申请61/439,525的优先权。以上申请的全文以引用的方式并入本文。
技术领域
本发明涉及负压伤口闭合装置。
背景技术
已经发展用于处理包括由事故造成的伤口和由手术造成的伤口的伤口的许多技术。通常,使用缝线或缝合钉使伤口闭合。然而,***这些机械闭合技术需要对皮肤做出额外刺破或伤口,这可能导致组织伤害且在过度肿胀的情况下可能造成缺血和组织损失。此外,诸如缝合钉和缝线的机械伤口闭合物可能在***点造成阻碍且损害皮肤的正常伤口愈合过程的高度局部压力。
近几年,已经越来越关注使用负压装置用于处理伤口。负压伤口处理通过对伤口施加负压抽吸而利用移除伤口积液的装置。据信这种负压会通过在伤口部位帮助形成肉芽组织并帮助身体正常炎症过程且同时移除过量积液(其可能含有不利细菌细胞因子)而促进伤口愈合。然而,需要进一步改善负压伤口治疗以完全实现处理的优点。
发明内容
本发明涉及一种尤其在伤口边缘用力以帮助伤口闭合的负压伤口闭合装置。所述装置用于减少一般采用的伤口填充材料的重复移位的需要且可增快愈合的速度。所述装置同时使用负压移除伤口积液。
在一个实施方案中,负压伤口闭合装置包括伤口填充材料,其被大小调整且塑形以配合在伤口开口内且在将负压施加至填充材料之后沿着至少一个第一维度收缩。所述填充材料因此被配置来在至少一个方向上优先收缩且在一个或多个额外方向上抑制收缩。先前负压装置无法辅助伤口闭合,而是用于排放积液。通过在愈合过程期间结合如结合本发明所述从伤口排放积液来提供组织的受控移动,可实现在愈合速度上的大幅改善。应注意,取决于伤口大小,可使用增加的负压。
在另一优选实施方案中,组织抓取表面在伤口填充材料的外周边表面上延伸且包括多个向外突出的组织锚,所述组织锚在所述伤口开口的边缘接合组织。在施加负压之后,移位所述伤口边缘的组织以帮助所述伤口的闭合。将诸如真空泵的负压源耦接至伤口填充材料以提供负压。
伤口填充材料通常包括多孔材料,诸如泡沫。对于采用组织锚的实施方案,这些可成一体地形成于填充材料中。在其它实施方案中,将组织锚提供在固定至填充材料的分开覆盖物或膜上。
在优选实施方案中,填充材料包括稳定结构以实现至少一个第一方向上的塌缩并且抑制至少一个第二方向上的塌缩。稳定结构可包括由相对可压缩材料围绕的一个或多个相对刚性材料区。在优选实施方案中,稳定结构是由刚性和/或半刚性材料形成的内骨架。
在特定实施方案中,稳定结构抑制填充材料沿其高度维度塌缩,同时实现填充材料在由伤口边缘限定的平面内塌缩。这在腹部手术的情况中是有用的,例如其中手术切口沿着直线形成椭圆形伤口。这个大致椭圆形伤口可延伸通过具有可变机械特性的肌肉和脂肪组织。较佳通过使用被调适成优先朝向切口的原线塌缩的椭圆形结构而提供伤口愈合。在优选实施方案中,稳定结构促进填充器以实现伤口组织的缝接的方式塌缩。可使用本发明的实施方案成功处理筋膜伤口或其它伤口开裂,或任何开放性伤口。
伤口闭合装置可用来处理纵隔膜中的伤口、处理压迫溃疡、处理手足情况(手臂或腿)中的伤口。伤口闭合装置还可用来处理不同形状的伤口,诸如圆形、正方形、矩形或非常规形状伤口。多个伤口闭合元件可被大小调整来配合在伤口内且可附接在一起以优先在所要方向上使伤口闭合。不同元件可包括不同材料或具有不同特征,诸如孔大小和/或锚大小和分布以形成复合结构。
在一个实施方案中,内骨架稳定结构包括多个隔开且形成交叉影线构造的刚性部件。内骨架使填充材料能够沿其宽度维度塌缩且沿其长度维度伸长至更小程度。在特定实施方案中,举例而言,多个刚性部件沿着填充材料的高度延伸且抑制所述填充物在其高度上塌缩。根据特定实施方案,内骨架包括互连刚性部件网络,其可在所述填充材料的塌缩期间相对于彼此关节式连接。内骨架可包括桁架支撑件以抑制填充材料的倾斜动作。在一些实施方案中个,组织锚可成一体地形成在内骨架中。
在特定实施方案中,伤口填充材料包括平滑底表面,其具有微孔以允许积液从伤口通过底表面且进入装置用于移除。微孔可具有可变孔大小和/或孔密度中以从负压源引导真空力的分配。在一些实施方案中,伤口填充材料可具有可变内孔大小和/或孔密度以引导真空力的分布。
在一个实施方案中,用于管理和/或移除积液的负压伤口处理组件耦接至伤口填充材料。单个负压源可用于伤口闭合和积液管理/排放。在伤口闭合物与积液管理组件之间的界面处提供有滑动表面。
在又另一实施方案中,填充材料包括可移除部分以调整伤口闭合装置的大小。填充材料可具有预定裂开线用于处理或切除材料的部分。在特定实施方案中,多组组织锚被嵌入填充材料中,且通过移除可移除部分而暴露。
根据另一实施方案,组织锚具有可变力分布。所述力分布可基于接合的组织的深度或组织的类型而变化。在一些实施方案中,组织抓取表面的力分布绕伤口闭合装置的周边改变。力分布通过例如改变组织锚的长度、锚的形状、锚的材料和锚的密度中的一个或多个而变化。
本发明还涉及使用如上所述伤口闭合装置使伤口闭合的方法。举例而言,腹部地层的皮肤中的线性切口提供对诸如人或动物身体的肠胃***的手术部位的接达。在完成以后,必须通过负压治疗处理伤口以促进恢复。因此,***根据本发明的优选实施方案的伤口闭合装置用于伤口闭合处理。
通过使用本发明的负压伤口闭合装置,具有大型或严重伤口的病患可免于或参加康复物理治疗,而变为在家且接着将其伤口恢复成简单地缝合闭合。通过改善伤口闭合处理且从而减少成本,这些装置有机会成为用于伤口护理设备的重要部分。
附图说明
结合附图后,从本发明的以下详细描述中本发明的其它特征和优点将显而易见,其中:
图1A是负压伤口闭合装置的透视示意图。
图1B是伤口闭合装置的组织抓取表面的截面图。
图1C是组织抓取表面的一个实施方案的侧视图。
图1D是以虚线示出x-y稳定器的伤口闭合装置的俯视图。
图1E是示出x-y稳定器和z稳定器的填充材料的截面图。
图1F是示出用于移除来自伤口部位的积液的光滑底表面和微孔的伤口闭合装置的仰视图。
图1G是周边稳定器元件的正视图。
图2A和图2B分别是支撑内骨架的透视图和侧视图。
图3A和图3B分别是具有支撑桁架的支撑内骨架的透视图和侧视图。
图3C是具有x形状支撑桁架的支撑内骨架的侧视图。
图4A至图4C图示使伤口闭合的本发明的伤口闭合装置。
图4D至图4E图示用于不同形状的伤口的多个伤口闭合元件的使用。
图5图示二级负压伤口处理和负压伤口闭合(NPWT/NPWC)装置。
图6图示根据本发明的组织锚***的优选实施方案的放大图。
图7图示具有用于适应不同伤口大小的撕开和切除设计的伤口填充材料的实施方案,其中组织锚嵌在预定裂开点的填充材料内。
图8A是组织抓取表面的侧视图,其图示用于不同类型组织(T1、T2)的不同组织锚和锚的各自力分布,包括真空闭合(F1)期间施加的最大力和没有破坏组织的情况下从组织移除锚所需的力(F2)。
图8B图示用于本发明的组织锚的不同设计。
图8C图示椭圆形伤口闭合装置的周边表面的组织锚元件的放大图。
图9A是根据一个实施方案的位于伤口内的伤口闭合装置的示意图,其示出伤口边缘周围的不同力分布。
图9B图示在伤口闭合和愈合时间后的图9A的伤口闭合装置,其中伤口的原始构造和伤口闭合装置以虚线指示。
图10示意性图示使用根据本发明的伤口闭合装置的手术。
具体实施方式
图1A至图1F图示本发明的伤口闭合装置100的实施方案。装置100包括被大小调整和塑形以配合于人或动物病患的伤口开口内的伤口填充材料102。在优选实施方案中,填充材料102是多孔、生物相容性材料,诸如开孔聚氨酯泡沫。填充材料102还可以优先是可塌缩的,此意味着可以通过将负压施加至填充材料102,同时在另一方向上抑制收缩或以较慢速率收缩而沿着至少一个维度(例如,长度、宽度、高度)减少其大小。
组织抓取表面104在填充材料102的至少一个表面上延伸,且优选地在填充材料102的外周界表面上延伸。在一个实施方案中,组织抓取表面104是柔韧性覆盖物(诸如网状膜),其固定至填充材料102的外周界表面且可以随着填充材料102的膨胀和收缩而膨胀和收缩。在一个实施方案中,组织抓取表面102是网状膜或复合聚酯网状膜,诸如来自Covidien(马萨诸塞州,曼斯菲尔德)的ParietexTM网。组织抓取表面104包括多个面向外组织锚元件106,其在优选实施方案中是可以成一体地形成于网状膜中的多个密集的倒钩、挂钩或组织抓取元件。
图1B是示出从伤口填充材料102的周边上的组织抓取表面104突出的组织抓取元件106的装置100的边视图。图1C是一个实施方案的侧视图,其中组织抓取表面104由柔韧性材料(特定来说,网状材料)形成。抓取元件106从图1C中的页状物突出。组织抓取表面104的柔韧性、网状材料允许表面在必要时随着底层伤口填充材料102的膨胀和收缩而膨胀和收缩。
在其它实施方案中,具有锚元件106的组织抓取表面104可以成一体地形成于填充材料102中。还可以使用可再吸收材料形成组织抓物表面和/或锚元件。
组织锚元件106优选地提供于填充材料102的整个外周界表面上。当填充材料102放置于伤口内时,锚元件106埋入于伤口边缘的组织内且将装置100固定于伤口开口内。组织锚元件106优选地在伤口边缘的整个表面上展开以在抓取力上提供足够强度。组织抓取表面104被优选地设计为允许伤口闭合装置100容易被放置,但是还容易被移除且根据需要(例如,2至7天后)被新装置100或者其它伤口敷料替换。抓取表面104可以被构造来在其表面的至少一部分上具有高抓取强度,但是可容易通过(例如)在边沿拉离而移除。组织抓取表面104被优选地设计为在不会损害周围组织下从伤口移除。锚元件106被优选地设计为适应不同组织应用(诸如肌肉、脂肪、皮肤和胶原蛋白)及其不同组合。在某些实施方案中,锚元件106还可以被设计为在所选时间段内保持固定地附接至特定组织。
在其中抓取表面104由填充材料102的外周边表面上的覆盖物形成的实施方案中,可以使用任何适当技术(诸如用粘合剂或机械固定***)将抓取表面附接至填充材料102。在优选实施方案中,组织抓取表面104包括可以是倒钩的填充物抓取锚元件,其将抓取表面固定至填充材料。如图6的截面图中所示,抓取表面400包括薄网或膜,其具有两组倒钩或类似锚元件:第一组410面向外组织抓取元件412,其被设计为突出至组织中;和第二组404元件406,其突出至填充材料中以将抓取表面固定至填充材料。
返回至图1A至图1F,负压源120(诸如泵)通过适当耦接件或导管(诸如管子121)耦接至填充材料102。额外管子107还可以通过间隔的口105阵列连接以在空间上分配吸力,使得沿着侧壁104运用的力可以脱离积液吸力而受控。可以启动负压源120以将负压施加至填充材料102。一般而言,负压引起所得压力差,其引起填充材料102收缩或“塌缩”。随着填充材料102收缩,组织抓取表面104在相邻组织上抓住和拉动,这导致组织移位,从而帮助伤口的闭合。在优选实施方案中,填充材料102被设计为优先在至少一个方向上塌缩。例如,在图1A的实施方案中,填充材料102包括分别沿着y轴和x轴的长度和宽度维度以及沿着z轴的高度。为了将负压有效地传输至皮下或其它伤口边缘,优选的是填充材料102不在z方向上中心塌缩(类似煎饼),使得负压的作用主要在x-y方向上起作用,或更特定来说,在沿着伤口边缘的二维平面上(诸如在打开的腹部或筋膜中)起作用。应理解,在一些实施方案中,诸如当伤口围绕腹部或腿的曲线扩散时,伤口边缘的平面可以是弯曲的。
此外,在优选的实施方案中,填充材料102被构造来优先在长度和/或宽度(即,沿着x轴和y轴)上塌缩以缝接伤口边缘的组织。应注意,可以在没有本文描述的锚元件下处理某些类型的伤口。
存在其中填充材料102被构造来展现优先塌缩特性的若干方法。例如,填充材料102的部分可以由比周围材料更具刚性的材料制造,这引起填充材料优先在特定方向上塌缩。在一个实施方案中,填充材料102可以包括由嵌入于“可塌缩”填充物(诸如开孔泡沫)内的适当刚性材料制造的稳定内骨架。应注意,施加的负压量可以取决于伤口的大小和形状而调整。125mm以上至多达250mm的压力可以用于帮助伤口闭合。压力可以随着伤口收缩,经过一段时间后减少。
如图1D和图1E中所示,例如,填充材料102可以包括多个稳定器元件108(以虚线示出),其可使填充材料在某些方向上塌缩,同时在其它方向上进行抑制。在这个实施方案中,稳定器元件108包括由适当刚性或半刚性材料(诸如塑料)制造的多个稳定肋状物、弯曲部分或杆状物。肋状结构被构造来优先沿着特定轴塌缩以帮助伤口的适当闭合。在这个实施方案中,内部稳定器元件108形成如图1D中所示的交叉影线图案,但是将理解,可以利用其它构造。例如,“开放式”状态中的元件之间的间距可以在1至2cm的范围中。可以如图1E的截面图中所示,在填充材料内的不同深度提供稳定器元件108,这帮助在z方向上抑制塌缩。在一些实施方案中,可以利用z轴稳定器元件110以在这个方向上抑制塌缩。在图1E中,z轴稳定器元件110是从肋状物108垂直延伸的突出部分。在其它实施方案中,可以采用单独z轴稳定器,诸如棒状物或肋状物结构。
在某些实施方案中,装置100可以包括图1E中所示的围绕填充材料102的外周边延伸的周边稳定器元件111。稳定器元件111可以包括肋状物结构,其强化填充材料102以在z方向上防止塌缩以及在z-y和z-x平面中抑制填充材料倾斜。因此,在施加负压之后,填充材料的优选实施方案优先在至少第一方向上相对于第二方向收缩。因此,例如,宽度将以较快速率相对于长度收缩,但是高度(伤口的深度)不会收缩一段实质性距离。
在一些实施方案中,组织抓取锚元件106可以包括在周边稳定器元件111上,且从填充材料102的周边突出。这可以作为在单独网或膜上提供锚元件106的替代或补充。周边稳定器元件111优先被构造来在必要时随着伤口填充材料102的膨胀和收缩而膨胀和收缩。因此,在优选实施方案中,稳定器元件111具有足够柔韧性以在x和y方向上(即,围绕填充材料102的周边)收缩和膨胀,但是沿着z方向(即,沿着填充物的高度)具有足够刚性以在这个方向上抑制塌缩或倾斜。
周边稳定器元件111的实施方案示出于图1G的正视图中。稳定器元件111包括被定向以在z方向上抑制塌缩的多个稳定棒状物113。棒状物113由柔韧性材料114分离,其允许稳定器元件111随着底层填充材料的膨胀和收缩围绕伤口边缘膨胀和收缩。在这个实施方案中,组织锚元件106形成于周边稳定器元件111中且从页状物突出。
本发明的伤口填充材料的内骨架的实施方案示出于图2A和图2B中。内骨架包括由多个z轴稳定器元件110连接的第一组x-y稳定器元件108a和第二组x-y稳定器元件108b。在填充材料102的塌缩期间,各自x-y稳定器元件108a、108b在x-y方向上是可塌缩的,但是z轴稳定器元件110在z方向上抑制塌缩。在优选实施方案中,稳定器元件可以在塌缩期间相对于彼此关节式连接。结构中的接点109可以被铰接或具有减少的厚度以适应***的挠曲。接点之间的弯曲部分还可以弯曲以适应沿着第一或横向轴117(参见图4B)的所期望的压缩。一些膨胀可以随着装置压缩而沿着第二或纵向轴119发生。框架材料可以具有形状记忆特性,其与吸力25组合来定义施加至组织的力水平。
在图3A和图3B中所示的另一实施方案中,内骨架包括在塌缩期间抑制填充材料102的倾斜的桁架稳定器112。随着填充材料102塌缩,桁架稳定器112使上108a和下108bx-y稳定器保持彼此对准。在一些实施方案中,桁架稳定器112可以在某些方向上具刚性且在其它方向上较不具刚性(例如,桁架稳定器可以为弓形)以在某些方向上促进塌缩。图3C图示具有呈“x”形图案的桁架稳定器112的替代实施方案。
在某些实施方案中的稳定内骨架可以整体或部分由形状记忆材料制造。可以使用不同形状记忆材料,其从变形状态(暂时形状)返回至其原始(永久)形状。形状上的这个改变可以由外部刺激或触发引发。在一个实施方案中,内骨架的原始或“永久”形状是伤口闭合装置的“塌缩”构造,或将导致伤口缝接的形状。当伤口闭合装置最初***于伤口开口中时,内骨架是呈变形或暂时状态且嵌入于填充材料内。内骨架可以优先恢复至其原始或“塌缩”状态,或者或是引起装置膨胀以接合组织。形状记忆内骨架的“塌缩”力可以是由负压源引发的真空力的补充或替代。在某些实施方案中,负压至伤口闭合装置的施加可以引起内骨架恢复至其原始状态。
图1F示出根据一个实施方案的伤口闭合装置100的底部。在这个实施方案中的装置100包括平滑底表面115。这个材料可以是与从Smith&Nephew购得的
Figure GDA0002139031320000081
***一起使用(诸如连同从Smith&Nephew购得的***提供)的生物相容性膜。优选实施方案还可以与如还在***中提供的计量器一起使用。底表面115在伤口闭合装置100与底层组织之间提供低摩擦界面。例如,在腹部伤口的情况下,底层组织可以包括内部器官,诸如肠。平滑底表面115可使填充材料102在没有来自底层组织的干扰下和没有损害底层组织下自由收缩和膨胀。在优选实施方案中,底表面115包括微孔116(为了图示的目的,在图1F中用放大的大小示出),其允许积液通过底表面115且进入装置100中以从伤口部位移除。伤口闭合装置还可以***于单独材料层上,使得装置在收缩下位于滑动层的顶部上。
在一些实施方案中,微孔116可以在不同区域可以具有不同大小和/或在不同区域中具有不同孔密度以将真空源的不同力水平引导至装置100的不同区域。类似地,填充材料102可以被设计为具有不同内部孔大小和/或孔密度以将力分配从真空源引导至装置100的不同区域。
图4A至图4C图示使伤口200闭合的本发明100的使用。伤口200包括如图4A中所示的伤口开口201和伤口边缘203。在图4B中,伤口闭合装置100放置于伤口开口201内,使得组织抓取表面104接触伤口边缘203。在某些实施方案中,可以通过将填充材料102修整或撕开为适当大小,接着围绕填充材料102的周边附接组织抓取元件106来形成伤口闭合装置100。在一个实施方案中,通过将两侧倒钩网附接至填充材料102来附接抓取元件106,在填充材料102处,面向外叉状物被设计为抓取组织且面向内叉状物被设定为将网固定至填充材料102。管子121将填充材料102连接至负压源。可以通过密封悬垂物205覆盖包括填充材料102的伤口200的区域。
在图4B的实施方案中,填充材料102包括给填充材料102提供优先塌缩特性的多个内部稳定器元件108(用虚线示出)。稳定器元件108在x方向和y方向上帮助控制填充材料102的塌缩和伤口边缘203周围的组织的所得移位。可以提供额外稳定器元件以沿着z方向控制或抑制塌缩。如上文连同图1D所描述,在这个实施方案中的稳定器元件108包括交叉影线构造。
图4C图示将负压施加至伤口闭合装置100之后的伤口200。组织锚元件106抓住组织边缘203且随着填充材料102塌缩而引起组织边缘203的移位。如图4C中所见,填充材料102按照以下方式在x方向和y方向上塌缩:在伤口边缘203缝接组织。在图4B和图4C的实施方案中,稳定器元件108的影线构造在塌缩期间帮助控制组织移位的方向。这个实施方案中的最大组织移位量是在伤口200的中心区域中,在此处,开口201最宽,且这个移位主要沿着x方向向内。在远离中心区域(例如,在如图4A和图4B中所示的伤口的顶部和底部),伤口边缘更紧密地在一起的地方,在x方向上不那么需要缝接组织。一般而言,不期望填充材料沿着y方向的向内塌缩。事实上,在组织缝接期间,伤口200将趋向于随着伤口边缘在x方向上闭合而在y方向伸长。在优选实施方案中,内部稳定器元件108以提供伤口缝接的方式促进填充材料的塌缩。例如,在图4-C的实施方案中,在填充物塌缩期间,交叉影线的稳定器元件108类似于可折叠门相对于彼此成直线。最大移位是沿着x方向,在填充物102的中心区域。稳定器102一般沿着y方向抑制向内塌缩。因为稳定器108成直线,所以其还帮助伤口在y方向上的伸长以允许适当组织缝接。在图4D至图4E中所示的是不同形状的伤口220、240,其中组合使用多个伤口闭合元件来填充伤口。在图4D中,元件222、224、226和228具有不同形状,这些形状被切割或修整为适当大小以便实质上填充在这个实例中,在形状上是圆形的伤口。当施加负压时,元件合作以使伤口在期望方向上闭合。图4E图示使用闭合元件242、244、246、248和250来填充伤口240的矩形伤口240。每个闭合元件的组织锚还可以附接至(若干)邻接闭合元件。在吸力施加至中心元件224、250的情况下,邻接元件朝着中心元件靠拢以使伤口闭合。
伤口闭合装置200可以这个构造保持几天或几周的一段时间以帮助伤口200的闭合和愈合。在一段愈合期之后,装置100可以被移除且视情况被较小装置替换。在使用本发明使伤口充分闭合之后,其可被缝合为闭合。
图5图示二级负压伤口处理和负压伤口闭合(NPWT/NPWC)装置300。装置包括本技术中所知的负压排放/积液管理组件301,其与底层负压伤口闭合装置100连接。伤口闭合装置100包括实质上如上文所描述的可塌缩伤口填充材料102和组织抓取表面104。管子121将装置300连接至单个泵以用于将负压施加至伤口闭合和伤口处理组件。装置300可以取决于特定伤口应用的需求而包括可互换零件。在一个实施方案中,装置300用于腹部伤口,且还可以用于纵隔膜和筋膜伤口。
在优选实施方案中,填充材料102能够在整个NPWT/NPWC装置300内“滑动”。填充材料102包括在伤口闭合物和积液管理组件之间的界面的滑动表面303。滑动表面可以包括处理表面或单独材料层。滑动表面303在没有来自积液管理组件的干扰下帮助伤口闭合组件的自由收缩。因为肉芽会减慢或抑制“滑动”,所以底层积液管理组件301尤其被构造来只管理积液且并不产生肉芽。
图6图示根据本发明的组织锚***400的优选实施方案的放大图。材料402的一侧具有第一组锚元件404,其被调适来抓取填充材料。第一锚元件404可以被塑形以利用(诸如)远侧挂钩形状406抓取填充材料。因为材料402必须在某个抓取强度下附接至填充物以将足够拉力施加于组织上,所以必须被施加以从填充材料移除挂钩的指定力水平F超出施加至组织的拉力。类似地,因为将由材料402抓取的组织具有不同于填充材料的结构特性,所以被调适来抓取组织的第二组锚元件410可以具有不同于第一锚元件的形状和抓取力。在这个实施方案中,倒钩412将为双侧叉状物414,其趋向于在***于组织之后塌缩且在相对方向上拉动时,仍膨胀,使得某个拉力可以施加至组织。但是,叉状物或圆锥形形状元件具有释放力,使得倒钩在不引起伤害下从组织手动拉开。
图7图示具有用于适应不同伤口大小的撕掉或切除设计的伤口填充材料500的实施方案。填充材料500包括自然裂开线501、503、505,其允许材料的大小被调整以配合伤口闭合。材料500被设计为在裂开线撕开或切除以移除材料的一个或多个部分502a、502b、502c且调整材料的大小。组织锚506a、506b、506c、506d的组在预定裂开点嵌入于填充材料内且随着各自外部分502a、502b、502c移除而暴露。组织锚506a、506b、506c、506d可以与(诸如)上文连同图1至图4描述的稳定内骨架结构关联。在一些实施方案中,稳定内骨架结构可以包括预定义裂开点,其随着调整填充材料500的大小而移除稳定器结构的部分。
图8A是图示用于不同类型的组织(T1、T2)的不同组织锚601、602、603、604的组织抓取表面的侧视图。还图示的是用于锚的各自力分布的实例,其包括在真空闭合期间施加至组织的最大力(F1)和在不损害组织下从组织移除锚所需的力(F2)。在一个实施方案中,组织锚的特性改变以跨越伤口闭合装置和周围组织之间的界面提供不同力分布。例如,对于(若干)上组织层T1,锚601被设计为附接至(诸如)真皮中的胶原蛋白材料。如图8A中所示,锚601在(若干)上组织层T1上具有不同力分布(F1和F2)。在下组织层T2,锚602、603、604被设计为附接至皮下层的脂肪组织。一般而言,需要较小力分布来将锚固定至这个组织。
锚和其所得力分布的特性可以随着许多参数(诸如锚的长度、锚的形状、抓取特征的结构、用于锚的(若干)材料、锚的相对柔韧性/刚性和锚的间距/密度)而改变。例如,在图8A中,锚601明显比锚602、603长,锚602、603转而比锚604长。图8A还图示改变(诸如)用602、603和604所示的锚的密度。图8B图示不同类型的抓取特征的三个实例,其包括倒钩构造605、交错挂钩构造606和交错倒钩构造607。可以利用其它适当抓取特征,诸如图8C的放大透视图所示的锚元件620。可以通过缝补填充材料或将内骨架支撑至组织来增强锚定过程。还可以通过控制填充材料中的真空力分配(诸如通过改变填充物的孔大小和/或孔密度)来改变力分布。
本发明的伤口闭合装置可以套件提供以用于使不同类型的伤口(例如,腹部、筋膜等等)闭合。组织抓取表面可以取决于伤口部位的组织的结构被最优化以用于不同类型的组织(诸如胶原蛋白、脂肪组织和肌肉)。
在某些实施方案中,伤口闭合装置的力分布在伤口周边周围是可变的。示例性实施方案图示于图9A中,其示出运用于伤口周边上的多个位置的伤口边缘上的力分布(f1)。在这个实施方案中,最大f1是在伤口填充物102的中心区域,在这个中心区域,伤口开口最宽且伤口闭合力完全或几乎完全在x方向上。朝着伤口的顶部区域和底部区域移动,闭合力(f1)小得多。此原因是因为伤口开口在这些区域中小得多,所以需要小得多的力来缝接组织。同样,运用于这些区域中的向内力包括在x方向和y方向两者上的分量。因此,较小力分布为优选的以避免组织在y方向上的向内塌缩。如图9B中所示,随着伤口从最初状态(由虚线指示)闭合和愈合至稍后状态(由实线指示),其在y方向上伸长。因此,组织锚701a和701b的移位专门在x方向和闭合力(f1)的方向上,但是组织锚703a、703b的移位在x方向上(在闭合力的方向上)向内和y方向(与闭合力相对的方向)上向外的两者中。因此,在这些区域中较小f1是优选的以在锚元件与周围组织之间提供更多“互动”。或者,伤口闭合装置被构造,使得其不伸长,而是不沿着长轴720改变其长度。
在伤口闭合装置的周边周围的力分布的变化可以各种方式实现,诸如改变组织锚的间距/密度,锚的类型、锚的长度等等。例如,在图9A和图9B中,相比于锚703a、703b,锚701a、701b更长且更深地穿透至组织中。还可以通过控制填充材料中的真空力分配(诸如通过改变填充物的孔大小和/或孔密度)来改变力分布。
在一个实施方案中,制造本发明的伤口闭合装置的方法包括形成刚性或半刚性材料的稳定内骨架且在内骨架上形成可塌缩填充材料。稳定内骨架可以使用模制工艺形成且可以模制为整体单元或模制于接着被组装以形成内骨架的一个或多个组件中。内骨架的不同组件可以具有不同厚度和/刚性度以沿着不同方向提供不同级别的刚性和柔韧性。可以通过结合组件(诸如通过使用适当粘合剂或其它结合工艺)组装内骨架。在某些实施方案中,可以组装至少一些组件以提供关节式连接接点。在优选实施方案中,通过将适当计量量的组成物质(例如,聚氨酯泡沫的情况下的异氰酸酯、多元醇、催化剂、表面活性剂、发泡剂等等)混合在一起,将反应混合物施配至模型中,接着使材料固化和脱模来形成填充材料。视情况,接着将材料切割或修整为完成后形状。在优选实施方案中,内骨架支撑结构被组装且放置于模型中,且填充材料围绕内骨架模制。适合于本伤口闭合装置的可生物降级泡沫产品和制造这样的泡沫的方法的实例描述于Rolfes等人的美国公开申请2009/0093550中,其全部内容以引用的方式并入本文中。
使用根据本发明的优选实施方案的伤口闭合装置执行外科手术800的方法如图10中所示。在使进行手术的病患做好准备800之后,切开820切口以使手术部位(通常在腹部)暴露。在执行手术之后,伤口准备830闭合。选择840伤口闭合装置的适当大小和形状,其中周边组织附接部件位于装置的外周或外壁表面周围。装置***850至伤口中且组织附接元件***860至组织中。接着施加870负压以将闭合力运用于伤口边缘上。取决于特定应用,大伤口可以在移除第一较大装置之后要求较小第二闭合的安置880。最后,移除890装置且通常通过缝补使伤口闭合。
虽然已连同特定方法和装置描述本发明,但是所属领域技术人员将认识到本文的特定实施方案的其它等效物。将理解,描述是举例说明且不作为对本发明的范畴的限制且这些等效物旨在由下文提出的权利要求书涵盖。

Claims (37)

1.一种负压伤口闭合装置,其包括:
伤口填充材料,其大小和形状形成为配合于伤口开口内且被配置成在将负压施加至所述伤口填充材料之后沿着相对于第二方向的至少第一方向优先收缩;
其中所述伤口填充材料具有沿y轴的长度维度、沿x轴的宽度维度以及沿z轴的高度维度,其中所述伤口填充材料包括稳定结构,所述稳定结构包括互连稳定器元件网络,以允许在至少一个第一方向上的塌缩并阻止在至少一个第二方向上的塌缩,所述稳定结构阻止在所述高度维度上的塌缩并且将所述伤口填充材料的塌缩限制在x-y平面,
其中在伤口填充材料的塌缩期间所述互连稳定元件网络相对于彼此关节式连接。
2.根据权利要求1所述的伤口闭合装置,其中所述互连稳定器元件网络包括多个稳定肋状物、弯曲部分或杆状物。
3.根据权利要求1所述的伤口闭合装置,其中所述互连稳定器元件网络包括形成了交叉影线构造的多个隔开的刚性部件。
4.根据权利要求1所述的伤口闭合装置,其中所述互连稳定器元件网络配置成允许所述伤口填充材料在所述宽度维度上塌缩并且在所述长度维度上伸长。
5.根据权利要求1所述的伤口闭合装置,其中所述互连稳定器元件网络包括刚性或半刚性材料,所述刚性或半刚性材料在所述高度维度上延伸并且阻止所述伤口填充材料在所述高度维度上塌缩。
6.根据权利要求1所述的伤口闭合装置,还包括在所述伤口填充材料的底表面之上延伸的平滑表面。
7.根据权利要求5所述的伤口闭合装置,其中所述伤口填充材料是围绕所述互连稳定器元件网络模制的。
8.根据权利要求1所述的伤口闭合装置,其中在塌缩后,所述稳定器元件相对于彼此成直线。
9.根据权利要求1所述的伤口闭合装置,其中所述伤口填充材料配置成优先在所述宽度维度上塌缩。
10.根据权利要求1所述的伤口闭合装置,其中所述伤口填充材料配置成仅在所述宽度维度上收缩且不在所述长度维度上塌缩。
11.根据权利要求1所述的伤口闭合装置,其中所述互连稳定器元件网络围绕被铰接的或者具有减少的厚度的接点关节式连接。
12.根据权利要求1所述的伤口闭合装置,其中在所述伤口填充材料塌缩之前,所述互连稳定元件网络的至少一部分隔开1-2cm。
13.根据权利要求1所述的伤口闭合装置,其中所述伤口填充材料的外周壁是椭圆形的。
14.根据权利要求1所述的伤口闭合装置,其中所述伤口填充材料包括多个刚性部件,所述刚性部件配置成在所述伤口填充材料放置在伤口开口中的时候沿所述伤口填充材料的高度方向延伸。
15.根据权利要求1所述的伤口闭合装置,其中所述伤口填充材料包括第一材料和第二材料,其中所述第一材料比第二材料相对更刚性。
16.一种负压伤口闭合装置,包括:
用于***伤口中的伤口填充物,所述伤口填充物配置成在负压下塌缩,所述伤口填充物具有对应于沿所述伤口填充物的中心纵向轴线延伸的y方向的长度、对应于x方向的宽度和对应于z方向的高度,所述x方向横向于所述长度并且沿所述伤口填充物的中心横向轴线延伸,所述z方向横向于所述长度和所述宽度,其中所述伤口填充物包括:
多个稳定器元件,在施加负压后所述稳定器元件允许所述伤口填充物在至少一个方向上塌缩并且抑制所述伤口填充物在所述z方向上塌缩,其中所述多个稳定器元件包括延伸穿过所述伤口填充物的第一多个稳定器元件和相对于所述第一多个稳定器元件成一角度延伸的第二多个稳定器元件,其中所述第二多个稳定器元件与所述第一多个稳定器元件互连并且在所述伤口填充物塌缩期间能够相对于所述第一多个稳定器元件关节式连接。
17.根据权利要求16所述的伤口闭合装置,其中所述第一多个稳定器元件包括相对于长度方向和/或宽度方向以一定角度延伸穿过所述伤口填充物的多个隔开的稳定器排,所述多个隔开的稳定器排的每个具有桁架稳定器,以在所述伤口填充物塌缩后保持所述多个隔开的稳定器排的上边缘和下边缘相互对齐。
18.根据权利要求17所述的伤口闭合装置,其中所述多个隔开的稳定器排是相互平行的。
19.根据权利要求16所述的伤口闭合装置,其中在所述伤口填充物塌缩之前所述多个隔开的稳定器排是隔开1-2cm。
20.根据权利要求16所述的伤口闭合装置,其中所述第二多个稳定器元件具有桁架稳定器,以在所述伤口填充物塌缩后保持所述第二多个稳定器元件中的每个的上边缘和下边缘相互对齐。
21.根据权利要求16所述的伤口闭合装置,其中通过使得填充材料在z方向上延伸,所述多个稳定器元件阻止所述伤口填充物在z方向上的塌缩。
22.根据权利要求21所述的伤口闭合装置,其中通过使得填充材料延伸穿过所述伤口填充物的整个厚度,所述多个稳定器元件阻止所述伤口填充物在z方向上的塌缩。
23.根据权利要求16所述的伤口闭合装置,其中所述多个稳定器元件包括在z方向上延伸的第三多个稳定器元件。
24.根据权利要求16所述的伤口闭合装置,其中所述伤口填充物配置成仅在x方向上塌缩而不在y方向上塌缩。
25.根据权利要求16所述的伤口闭合装置,其中所述第一多个稳定器元件和所述第二多个稳定器元件形成交叉影线图案。
26.根据权利要求16所述的伤口闭合装置,其中所述伤口填充物具有带第一侧和第二侧的椭圆形外周边,第一侧和第二侧在所述伤口填充物的长度上延伸,其中所述第一侧与所述第二侧相对,并且所述第一侧和所述第二侧相对于所述中心纵向轴线向外弯曲,以提供具有至少部分椭圆形的稳定结构的外周。
27.根据权利要求16-26任一项所述的伤口闭合装置,还包括组织抓取层和从所述组织抓取层突出的多个组织抓取元件,所述组织抓取层配置成固定到所述伤口填充物的外周。
28.根据权利要求16所述的伤口闭合装置,还包括配置成接合到所述伤口填充物的负压源。
29.根据权利要求16所述的伤口闭合装置,还包括配置成将要放置在位于所述伤口填充物下方的伤口中的平滑底膜。
30.根据权利要求16所述的伤口闭合装置,其中所述第二多个稳定器元件能够使用铰接机构相对于所述第一多个稳定器元件关节式连接。
31.根据权利要求16所述的伤口闭合装置,其中所述第二多个稳定器元件在具有减小厚度的接点能够相对于所述第一多个稳定器元件关节式连接。
32.根据权利要求16所述的伤口闭合装置,其中在所述伤口填充材料塌缩期间,所述第一多个稳定器元件和所述第二多个稳定器元件进行相对移动,使得所述第一稳定器元件和所述第二稳定器元件的至少一个向所述中心纵向轴线旋转。
33.一种负压伤口闭合装置,包括:
伤口填充物,具有用于***伤口中的椭圆形外周边,所述伤口填充物配置成在负压下塌缩,所述伤口填充物具有对应于沿所述伤口填充物的中心纵向轴线延伸的y方向的长度、对应于x方向的宽度和对应于z方向的高度,所述x方向横向于所述长度并且沿所述伤口填充物的中心横向轴线延伸,所述z方向横向于所述长度和所述宽度,其中所述伤口填充物包括:
在x-y平面上相互隔开并且延伸穿过所述伤口填充物的多个稳定器排,所述多个稳定器排的每个是在所述z方向上刚性或半刚性的;
在x-y平面上相互隔开的多个互连的稳定器元件,其与所述多个稳定器排互连,其中所述多个稳定器排和所述多个互连的稳定器元件在所述伤口填充物塌缩期间能够相互关节式连接;
其中在施加负压时,所述多个稳定器排和所述多个互连的稳定器元件允许所述伤口填充物在x-y平面上的塌缩并且抑制所述伤口填充物在z方向上的塌缩。
34.根据权利要求33所述的伤口闭合装置,还包括配置成连接到所述伤口填充物的负压源。
35.根据权利要求33所述的伤口闭合装置,还包括配置成将要放置在位于所述伤口填充物下方的伤口中的平滑底膜。
36.根据权利要求33所述的伤口闭合装置,其中所述多个稳定器排和所述多个互连的稳定器元件能够使用铰接机构相互关节式连接。
37.根据权利要求33所述的伤口闭合装置,其中所述多个稳定器排和所述多个互连的稳定器元件能够在具有减少厚度的接点相互关节式连接。
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