CN103877627A - 开腔式减压处理设备和系统 - Google Patents
开腔式减压处理设备和系统 Download PDFInfo
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Abstract
提供了一种用于处理患者体内的例如腹腔的腔的开腔式减压处理设备和系统。在一个情况中,开腔式减压处理设备包括多个封装的腿构件和被流体地联接至多个封装的腿构件的中央连接构件,每个封装的腿构件具有设有腿歧管构件的内部部分并且形成有可操作以允许流体流入内部部分的穿孔。中央连接构件具有连接歧管构件。除了别的方面之外,开腔式减压处理设备、系统和方法允许用于流体的移除。
Description
本申请是申请日为2009年5月15日,申请号为200980142676.1,发明名称为“开腔式减压处理设备和系统”的申请的分案申请。
相关申请
根据美国法典第35卷第119条(e)款,本发明要求2008年10月29日提交的标题为“Reduced-Pressure,Wound-Closure System and Method”的美国临时专利申请序列号61/109,410、2008年10月29日提交的标题为“Reduced-Pressure,Abdominal Treatment System and Method”的美国临时专利申请序列号61/109,486、2008年10月29日提交的标题为“Open-Cavity,Reduced-Pressure Wound Dressing and System”的美国临时专利申请序列号61/109,390以及2008年10月29日提交的标题为“Reduced-Pressure,Deep-Tissue Closure System and Method”的美国临时专利申请序列号61/109,448的利益。为了所有的目的,所有这些临时申请在此通过引用被并入。
技术领域
本发明大体上涉及医疗处理系统,并且更具体地,涉及开腔式减压处理设备和系统。
背景技术
无论伤口或损坏的组织区域的病因是外伤、手术还是其它原因,所述伤口的适当护理对于结果都很重要。当伤口涉及需要重新进入的位置例如腹膜腔和更一般地腹腔时,存在独特的挑战。通常,当手术或外伤涉及腹腔时,建立便于重新进入的伤口处理系统允许更好和更容易的护理,并且帮助解决例如腹膜炎、腹腔间隔室综合症以及可能抑制伤口和内部器官的最终愈合的感染的情况。在提供这样的护理中,可能期望从腔移除不需要的流体、帮助接近筋膜和其它组织并且最终帮助在表皮水平面处伤口本身上提供闭合力。
目前,可使用缝线、U形钉、夹具和其它机械设备来闭合表皮上的腹部开口,以允许皮肤或表皮被保持和牵引。这些设备在伤口本身中会引起伤口并且会引起伤口本身的伤口。而且,不用很多,如果发生浮肿,极大的压力可能被置于闭合设备上,并导致潜在的伤害。例如,如果压力因浮肿而升高,则缝线可能会撕开。
对于用于允许重新进入腹腔的总系统,已发展了大量的技术。一种方法是将毛巾放入腔中,然后使用例如止血钳的夹具使皮肤在毛巾上方闭合。虽然简单并迅速,但结果显现出被视为不是最佳的。另一种方法是“Bogota袋(Bogota bag)”。使用这种方法,将袋缝入覆盖打开的腹部的位置中。有时称为“真空填塞(vac pack)”的再一种方法是将毛巾填塞在伤口中,然后将排液管放入腹部中,并用盖布覆盖腹部。最后,使用一种减压方法。这种方法在Hunt等人的并且转让给德克萨斯州San Antonio的KCI Licensing有限公司的美国专利7,381,859中被说明。为了所有的目的,在此通过引用将美国专利7,381,859并入。
除了为重新进入而接近腔之外,从腔移除流体可能是合乎需要的。为组织或伤口包括可能在腹腔内的伤口提供减压治疗可能是合乎需要的。该处理(在医疗机构经常被称作“负压伤口治疗”、“减压治疗”或“真空治疗”)可提供许多益处,包括快速的愈合和增长的肉芽组织的形成。
提供能够从腹腔移除过量流体、通过提供非粘性屏障保护腹腔内部以及输送减压的系统和方法将是合乎需要的。此外,提供一种能够容易地被放置在腹腔中的各个位置例如结肠沟中、被快速地安装以及容易地适应不同尺寸区域的系统将是合乎需要的。
发明内容
对于例如腹腔的开腔的现有敷料和系统的弊端通过本文中所描述的说明性实施方式的系统、装备和方法来解决。根据一个说明性实施方式,一种用于在患者体腔内提供减压处理的减压处理系统可包括具有多个封装的腿构件的处理设备,每个封装的腿构件具有设有腿歧管构件(legmanifold member)的内部部分并且形成有可操作以允许流体流入内部部分的穿孔。处理设备还包括具有连接歧管构件的中央连接构件,并且其中每个腿歧管构件与连接歧管构件流体连通。中央连接构件具有第一侧和面向内的第二侧。减压处理系统还包括:用于邻近中央连接构件的第一侧布置并且可操作以将减压分配至中央连接构件的歧管;用于布置在患者表皮的一部分上并且可操作以在体腔上形成气动密封的密封构件;减压导管;以及用于产生减压的减压源。减压源流体地联接至减压输送导管,减压输送导管流体地联接至减压接驳体。
本发明提供了一种开腔式减压处理系统,其用于在患者体腔内提供减压处理,该开腔式减压处理系统包括:
处理设备,其包括:
多个封装的腿构件,每个封装的腿构件具有内部部分,在内部部分中定位有腿歧管构件,腿构件包含穿孔以允许流体在封装的腿构件的外表面和内部部分之间流动,和
中央连接构件,其中中央连接构件具有连接歧管构件,且其中多个腿歧管构件与连接歧管构件流体连通,中央连接构件具有第一侧和面向内的第二侧;
歧管,其用于邻近中央连接构件的第一侧布置并且可操作以将减压分配至中央连接构件;
密封构件,其用于布置在患者表皮的一部分上并且可操作以在体腔上形成气动密封;
减压输送导管;
减压源,其用于产生减压,减压源流体地联接至减压输送导管;以及
减压接驳体,其用于联接至密封构件并且可操作以将减压输送导管流体地联接至歧管。
在该系统中,多个封装的腿构件可包括:第一腿封装构件;形成有穿孔的第二腿封装构件;其中,腿歧管构件具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;并且其中,第一腿封装构件可邻近腿歧管构件的第一侧布置,第二腿封装构件可邻近腿歧管构件的面向内的第二侧布置,且第一腿封装构件和第二腿封装构件可邻近腿歧管构件的第一侧向边缘和第二侧向边缘联接。
在该系统中,中央连接构件可包括:形成有穿孔且具有外围边缘的第一连接封装构件;形成有穿孔的第二连接封装构件;并且其中,第一连接封装构件的外围边缘可至少部分地被联接至第二连接封装构件。
在该系统中,多个封装的腿构件中的每个封装的腿构件可包括:形成有穿孔的第一腿封装构件;形成有穿孔的第二腿封装构件;其中,腿歧管构件可具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;其中,第一腿封装构件可邻近腿歧管构件的第一侧布置,第二腿封装构件可邻近腿歧管构件的面向内的第二侧布置,且第一腿封装构件和第二腿封装构件可邻近腿歧管构件的第一侧向边缘和第二侧向边缘联接;并且其中,中央连接构件可包括:形成有穿孔且具有外围边缘的第一连接封装构件;形成有穿孔的第二连接封装构件;并且其中,第一连接封装构件的外围边缘可至少部分地被联接至第二连接封装构件。进一步地,该开腔式减压处理系统还可包括非粘性盖布,且其中第二腿封装构件可包括非粘性盖布的至少一部分。
根据另一个说明性实施方式,一种用于处理体腔中的组织部位的开腔式减压处理设备包括多个封装的腿构件,每个封装的腿构件具有设有腿歧管构件的内部部分。多个封装的腿构件形成有可操作以允许流体流入内部部分的穿孔。开腔式减压处理设备还包括中央连接构件,中央连接构件具有连接歧管构件。多个封装的腿构件与连接歧管构件流体连通。
本发明还提供了一种开腔式减压处理设备,其用于处理体腔中的组织部位,处理设备包括:
多个封装的腿构件,封装的腿构件具有内部部分,在内部部分中布置有腿歧管构件,多个封装的腿构件形成有可操作以允许流体流入内部部分的穿孔;
中央连接构件,其中中央连接构件具有连接歧管构件,且其中腿歧管构件与连接歧管构件流体连通;以及
下表面,下表面在多个封装的腿构件和中央连接构件的下方和之间延伸,其中穿孔延伸穿过下表面。
在该处理设备中,多个封装的腿构件中的每个封装的腿构件可包括:第一腿封装构件;形成有穿孔的第二腿封装构件;其中,腿歧管构件可具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;其中,第一腿封装构件可邻近腿歧管构件的第一侧布置,第二腿封装构件可邻近腿歧管构件的面向内的第二侧布置,且第一腿封装构件和第二腿封装构件可邻近腿歧管构件的第一侧向边缘和第二侧向边缘联接。
进一步地,该处理设备还可包括非粘性盖布,且其中第二腿封装构件可包括非粘性盖布的至少一部分。进一步地,在该处理设备中,非粘性盖布还可包括指示出尺寸刻度的可视标记。
在该处理设备中,多个封装的腿构件中的每个封装的腿构件可包括多个腿模块。
在该处理设备中,还可包括界定下表面的非粘性盖布。
在该处理设备中,中央连接构件可包括:形成有穿孔且具有外围边缘的第一连接封装构件;形成有穿孔的第二连接封装构件;并且其中,第一连接封装构件的外围边缘可至少部分地被联接至第二连接封装构件。
在该处理设备中,多个封装的腿构件中的每个封装的腿构件可包括:形成有穿孔的第一腿封装构件;形成有穿孔的第二腿封装构件;其中,腿歧管构件可具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;其中,第一腿封装构件可邻近腿歧管构件的第一侧布置,第二腿封装构件可邻近腿歧管构件的面向内的第二侧布置,且第一腿封装构件和第二腿封装构件可邻近腿歧管构件的第一侧向边缘和第二侧向边缘联接;并且其中,中央连接构件可包括:形成有穿孔且具有外围边缘的第一连接封装构件,形成有穿孔的第二连接封装构件,并且其中,第一连接封装构件的外围边缘可至少部分地被联接至第二连接封装构件。
根据另一个说明性实施方式,一种制造用于在患者体腔中使用的减压处理设备的方法包括以下步骤:形成多个封装的腿构件,每个封装的腿构件具有设有腿歧管构件的内部部分并且形成有可操作以允许流体流入内部部分的穿孔。制造减压处理设备的方法还包括形成具有连接歧管构件的中央连接构件并且将中央连接构件流体地联接至多个封装的腿,其中每个腿歧管构件与连接歧管构件流体连通。该说明性方法还包括在非粘性盖布上设置指示出能被切割的各种尺寸的可视标记。
在该方法中,形成多个封装的腿构件的步骤、形成具有连接歧管构件的中央连接构件的步骤以及将中央连接构件联接至多个封装的腿构件的步骤可包括以下步骤:提供第一非粘性盖布,邻近第一非粘性盖布的表面放置歧管单元,歧管单元可具有连接歧管构件和多个腿歧管构件;在歧管单元上方放置第二非粘性盖布;以及联接第一非粘性盖布和第二非粘性盖布以形成多个封装的腿构件和中央连接构件。
在该方法中,形成多个封装的腿构件的步骤、形成具有连接歧管构件的中央连接构件的步骤以及将中央连接构件联接至多个封装的腿构件的步骤可包括以下步骤:提供第一非粘性盖布,邻近第一非粘性盖布的表面放置歧管单元,歧管单元可具有连接歧管构件和多个腿歧管构件;在歧管单元上方放置第二非粘性盖布;联接第一非粘性盖布和第二非粘性盖布以形成多个封装的腿构件和中央连接构件;以及切割第一非粘性盖布和第二非粘性盖布。
在该方法中,形成多个封装的腿构件的步骤、形成具有连接歧管构件的中央连接构件的步骤以及将中央连接构件联接至多个封装的腿构件的步骤可包括以下步骤:提供第一非粘性盖布,邻近第一非粘性盖布的表面放置歧管单元,歧管单元可具有连接歧管构件和多个腿歧管构件;在歧管单元上方放置第二非粘性盖布;联接第一非粘性盖布和第二非粘性盖布以形成多个封装的腿构件和中央连接构件;其中联接第一非粘性盖布和第二非粘性盖布的步骤可包括将第一非粘性盖布结合至第二非粘性盖布;以及还可包括切割第一非粘性盖布和第二非粘性盖布。
该方法可包括形成具有穿孔的非粘性盖布的步骤,且其中形成多个封装的腿构件的步骤可包括将非粘性盖布的至少一部分用作腿封装的构件。
进一步地,在该方法中,形成非粘性盖布的步骤可包括:形成弹性体盖布、形成穿过弹性体盖布的穿孔以及在弹性体盖布上设置指示出能被切割的各种尺寸的可视标记。
进一步地,在该方法中,对于每个封装的腿构件,形成多个封装的腿构件的步骤可包括以下步骤:形成第一腿封装构件;在第一腿封装构件中形成穿孔;形成第二腿封装构件;在第二腿封装构件中形成穿孔;使第一腿封装构件邻近腿歧管构件的第一侧布置;其中,腿歧管构件可具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;使第二腿封装构件邻近腿歧管构件的面向内的第二侧布置;以及使第一腿封装构件和第二腿封装构件邻近腿歧管构件的第一侧向边缘和第二侧向边缘联接。
进一步地,在该方法中,形成中央连接构件的步骤可包括以下步骤:形成具有外围边缘的第一连接封装构件;在第一连接封装构件中形成穿孔;形成第二连接封装构件;在第二连接封装构件中形成穿孔;以及将第一连接封装构件的外围边缘至少部分地联接至第二连接封装构件。
进一步地,在该方法中,对于每个封装的腿构件,形成多个封装的腿构件的步骤可包括以下步骤:提供腿歧管构件,其中腿歧管构件可具有第一侧、面向内的第二侧、第一侧向边缘和第二侧向边缘;形成第一腿封装构件;形成第二腿封装构件;在第二腿封装构件中形成穿孔;使第一腿封装构件邻近腿歧管构件的第一侧布置;使第二腿封装构件邻近腿歧管构件的面向内的第二侧布置;使第一腿封装构件和第二腿封装构件联接;且
其中,形成中央连接构件的步骤可包括以下步骤:提供具有第一侧和面向内的第二侧的连接歧管构件;形成具有外围边缘的第一连接封装构件;在第一连接封装构件中形成穿孔;形成第二连接封装构件;在第二连接封装构件中形成穿孔;将第一连接封装构件布置在连接歧管构件的第一侧上;将第二连接封装构件布置在连接歧管构件的面向内的第二侧上;以及将第一连接封装构件的外围边缘至少部分地联接至第二连接封装构件。
根据另一个说明性实施方式,一种在患者腹腔中提供减压处理的方法可包括以下步骤:将处理设备布置在腹腔中,其中处理设备具有多个封装的腿构件和中央连接构件,每个封装的腿构件具有设有腿歧管构件的内部部分并且形成有可操作以允许流体流入内部部分的穿孔,其中中央连接构件具有连接歧管构件且其中每个腿歧管构件与连接歧管构件流体连通。中央连接构件具有第一侧和面向内的第二侧。该方法还包括:使多个封装的腿构件中的至少一个封装的腿构件邻近腹腔中的结肠沟放置;使歧管邻近中央连接构件的第一侧放置;将密封构件放置在患者表皮的一部分上以在体腔上形成气动密封;将减压接驳体联接至密封构件;以及将减压导管联接至减压接驳体以将减压输送至歧管。该说明性方法还可包括在将处理设备布置在体腔中之前为处理设备设置尺寸的步骤。
本发明还提供了一种提供减压处理的方法,用于在患者腹腔中提供减压处理,该方法包括以下步骤:
将处理设备布置在腹腔中,其中处理设备包括:
多个封装的腿构件,封装的腿构件具有设有腿歧管构件的内部部分并且形成有可操作以允许流体流入内部部分的穿孔,和
中央连接构件,中央连接构件联接至多个封装的腿构件,其中中央连接构件具有连接歧管构件,且其中每个腿歧管构件与连接歧管构件流体连通,中央连接构件具有第一侧和面向内的第二侧;
使所述多个封装的腿构件中的至少一个封装的腿构件邻近腹腔中的结肠沟放置;
使歧管邻近中央连接构件的第一侧放置;
将密封构件放置在患者表皮的一部分上以在腹腔上形成气动密封;
将减压接驳体联接至密封构件;以及
将减压导管联接至减压接驳体以将减压输送至歧管。
该方法还可包括为处理设备设置尺寸的步骤。
在该方法中,处理设备还可包括具有指示出可能尺寸的可视标记的非粘性盖布,并且其中为处理设备设置尺寸的步骤可包括邻近表示所需尺寸的可视标记切割非粘性盖布。根据另一个说明性实施方式,本发明还提供了一种开腔式减压处理设备,包括:
中央流体毂状物,其具有上表面和下表面,流体毂状物包括界定上表面的至少一部分的泡沫歧管和界定下表面的至少一部分的基本上流体不能渗透的壁,流体不能渗透的壁包括多个孔,
多个细长构件,其具有近端和远端以及上表面和下表面,细长构件包括被封闭在基本上流体不能渗透的壁内的泡沫,多个细长构件的近端与中央流体毂状物流体连通,细长构件包括沿着细长构件的下表面的至少一部分延伸穿过所述流体不能渗透的壁的孔,
其中,多个细长构件具有从中央流体毂状物延伸的第一长度L1和大体上平行于细长构件的上表面的第一宽度(W1),
其中,中央流体毂状物具有在第一细长构件和第二细长构件之间的第二宽度(W2);
其中,第二宽度大于第一宽度(W2>W1)。
其中,多个细长构件的长宽比(L1比W1)可处在3.0至10.0的范围中;
其中,多个细长构件的长宽比可大于3.5。
该处理设备还可包括在多个细长构件之间延伸的基本上流体不能渗透的材料。
该处理设备还可包括在多个细长构件之间延伸的可膨胀的材料。
参考附图和下面的详细描述,说明性实施方式的其它目的、特征和优势将变得明显。
附图说明
图1A是开腔式减压处理设备和系统的说明性实施方式的示意图,其中一部分为截面形式;
图1B是图1A的处理设备的一部分的示意性截面;
图1C是沿着线1C-1C截取的图1A处理设备的一部分的示意性截面;
图1D是图1A的系统的一部分的示意性截面;
图2是图1A-1D的开腔式减压处理设备的说明性实施方式的示意性透视图;
图3A是开腔式减压处理设备的另一个说明性实施方式的示意性平面图;
图3B是图3A的处理设备的一部分的示意性平面图;
图3C是沿着线3C-3C截取的图3B处理设备的一部分的示意性截面;
图4是开腔式减压处理设备的另一个说明性实施方式的示意性透视图;以及
图5是开腔式减压处理设备的另一个说明性实施方式的示意性平面图。
具体实施方式
在下面的说明性实施方式的详细描述中,参考形成其一部分的附图。这些实施方式足够详细地被描述,以使本领域技术人员能够实践本发明,且应理解,可利用其它的实施方式并且可进行逻辑结构的、机械的、电的以及化学的改变而不偏离本发明的精神或范围。为避免对于使本领域技术人员能够实践本文所述的实施方式来说不必要的细节,本描述可省略对本领域技术人员已知的一些信息。因此,下面的详细描述不应在限制的意思上理解,且说明性实施方式的范围仅由所附的权利要求限定。
参考图1A-1D,示出了开腔式减压系统100和处理设备102的说明性实施方式。开腔式减压系统100和处理设备102是用于处理患者的组织部位104的。组织部位104可以是任何人类、动物或其它生物体的身体组织,包括骨组织、脂肪组织、肌肉组织、皮组织、组织、结缔组织、软骨、腱、韧带或任何其他组织。在说明性实施方式中,组织部位104包括在体腔且特别是在腹腔中的组织,并且包括邻近腹腔的腹部内容物或组织。组织部位104的处理可包括移除例如腹水的流体、腹腔的保护或减压治疗。除非另外指明,如本文所使用的,“或”不要求互斥性。
如所示,处理设备102布置在患者的腹腔内以处理组织部位104。处理设备102包括由腹部内容物支撑的多个封装的腿构件106,多个封装的腿构件106被放置在腹部内容物组成的表面上。可在第一结肠沟108中或邻近第一结肠沟108放置多个封装的腿构件106中的一个或多个,并且可在第二结肠沟110中或邻近第二结肠沟110放置多个封装的腿构件106中的一个或多个。多个封装的腿构件106被联接至中央连接构件112,并且在多个封装的腿构件106与中央连接构件112之间形成了流体连通。多个封装的腿构件106和/或中央连接构件112可形成有允许腹腔中的流体通过的穿孔114、116、118、120。穿孔114、116、118、120可采用任何形状,例如环形孔、矩形开口、多边形等,但在该说明性实施方式中表现为狭长切口或线形切口。在可选的实施方式中,可省略一个或多个穿孔114、116、118、120。
歧管122或歧管垫将减压分配至处理设备102。密封构件124在体腔开口126的上方提供气动密封。在患者表皮134上可放置一个或多个皮肤闭合设备。通过被联接至减压输送导管130的减压接驳体128,减压被输送至歧管122。减压源132将减压输送至减压输送导管130。
减压可被施加于组织部位104,以帮助促进从组织部位104移除腹水、渗出液或其它流体。在某些情况中,减压可被用于刺激另外组织的生长。在某些情况中,仅流体移除可能是合乎需要的。在组织部位104处的伤口的情况下,肉芽组织的生长、渗出液的移除或细菌的移除可帮助促进伤口愈合。在非创伤性或非缺陷性组织的情况中,减压可在某些情况中被使用以促进可被切除并移植到另一组织部位的组织的生长。如本文所使用的,“减压”一般指压力小于被进行处理的组织部位处的环境压力。在大部分情况中,该减压将小于患者所在位置处的大气压。可选地,减压可小于组织部位处的流体静压。减压在歧管122中、减压导管130中和邻近组织部位104处可最初产生流体流动。当组织部位104周围的流体静压达到所需的减压时,流动可减退且减压可被维持。除非另外指明,本文所陈述的压力值是表压。
歧管122邻近中央连接构件112。歧管122可采用多种形式。如本文所使用的,术语“歧管”一般指被设置成帮助向组织部位104施加减压、向组织部位104输送流体或从组织部位104移除流体的物质或结构。歧管122通常包括多个流动通道或通路,该多个流动通道或通路对被提供至歧管122周围的组织部位104的流体和通过中央连接构件112从歧管122周围的组织部位104被移除的流体进行分配。在一个说明性实施方式中,流动通道或通路相互连接,以改善被提供至组织部位104或从组织部位104移除的流体的分布。歧管122可以是能够被放置成与组织部位104接触并分配减压至组织部位104的生物相容性材料。歧管122的示例可包括且不限于:具有被布置成形成流动通道的结构元件的设备、例如开孔式泡沫的多孔状泡沫、多孔组织聚集物以及包括或固化成包括流动通道的液体、凝胶和泡沫。歧管122可以是多孔的,并且可以由泡沫、纱布、毡垫或任何其它的适合于特定生物应用的材料制成。在一个实施方式中,歧管122是多孔泡沫并且包括充当流动通道的多个相互连接的小室或孔。多孔泡沫可以是聚氨基甲酸酯开孔网状泡沫,例如由德克萨斯州San Antonio的KineticConcepts股份有限公司制造的材料。其它的实施方式可包括“闭室”。歧管的这些闭室部分可包含多个小室,该多个小室的大部分没有流体连接至相邻的小室。闭室可选择地被布置在歧管122中,以阻止流体通过歧管122的周边表面传输。在一些情况中,歧管122也可用于将例如药物、抗菌物、生长因子和其它溶液的流体分配至组织部位104。在歧管122中或歧管122上可包括例如吸收材料、芯吸材料、疏水性材料和亲水性材料的其它层。
密封构件124可放置在体腔开口126的上方,并且为开腔式减压系统100提供足够的气动密封以保持在组织部位104处的减压。密封构件124可以是用于将歧管122固定在中央连接构件112上的覆盖物。密封构件124可以是不渗透的或半渗透的。密封构件124在密封构件124安装在体腔开口126上方之后能够维持在组织部位104处的减压。密封构件124可以是由硅树脂基化合物、丙烯酸、水凝胶或水凝胶形成材料或包括施加减压至组织部位104所需的不渗透特性或渗透特性的任何其它生物相容性材料形成的柔性的上盖布(over-drape)或膜。
密封构件124还可包括附接装置131,以将密封构件124固定至患者的表皮134。附接装置131可采用多种形式;例如,粘性层136可沿着密封构件124的周边或密封构件124的任何部分定位,以便为患者的表皮134直接地或间接地提供气动密封。粘性层136还可以被预先应用至密封构件124并且用可释放的背衬或构件(未示出)覆盖,该可释放的背衬或构件在应用的时候被移除。
作为一个示例,减压接驳体128可以是口或连接器138,该口或连接器138允许流体从歧管122输送至减压输送导管130,并且反之亦然。例如,使用歧管122和处理设备102从组织部位104收集的流体经由连接器138可进入减压输送导管130。在另一个实施方式中,开腔式减压系统100可省略连接器138,并且减压输送导管130可直接插入密封构件124和歧管122中。减压输送导管130可以是医用导管或管或用于输送减压和流体的任何其它装置。减压输送导管130可以是用于容易地输送减压并移除流体的多管腔构件。在一个实施方式中,减压输送导管130是双管腔导管,其中一个管腔用于减压和液体传输,而一个管腔用于将压力传送至压力传感器。
通过减压源132产生减压并将减压供应给减压输送导管130。通过减压源132可产生或供应较宽范围的减压。在一个实施方式中,该范围可包括范围-50mmHg至-300mmHg,而在另一个实施方式中,范围可包括-100mmHg至-200mmHg。在一个说明性实施方式中,减压源132包括用于-100mmHg、-125mmHg和-150mmHg的预置选择器。减压源132也可包括多个警报,例如堵塞警报、泄漏警报或电量低警报。减压源132可以是便携式源、墙式源(wall source)或用于腹腔的其他单元。减压源132可选择性地输送恒定压力、变化压力、间歇压力或连续压力。每天通过减压输送导管130从腔移除的流体可达5L那么多或更多。
很多不同的设备例如设备140可被添加至减压输送导管130的中间部分(medial portion)142。例如,设备140可以是流体储蓄器、或罐收集构件、压力反馈设备、体积检测系统、血液检测系统、感染检测系统、过滤器、带有过滤器的口、流量监控系统、温度监控系统等。也可包括多个设备140。这些设备中的一些例如流体收集构件可与减压源132整体地形成。例如,在减压源132上的减压口144可包括过滤器构件(未示出),该过滤器构件包括一个或多个过滤器并且可包括阻止液体进入减压源132的内部空间的疏水性过滤器。
现在参考图1C、图1D和图2,处理设备102可包括非粘性盖布148。非粘性盖布148可由抑制组织粘贴至非粘性盖布148的非粘性材料形成。在一个实施方式中,非粘性盖布148由可透气的聚氨基甲酸酯膜形成。非粘性盖布148可包括多个开口、孔或穿孔150。穿孔可采用各种形状,例如环形开口、矩形开口、多边形开口等,但是在图2中所示为狭长切口或线形切口。根据设备102的具体应用、所需的流体流量和/或压力输送或其它系统参数,穿孔可以是不同的尺寸。
处理设备102包括被联接有多个封装的腿构件106的中央连接构件112。中央连接构件112包括由第一连接封装构件186和第二连接封装构件192封装的歧管构件154。然而,中央连接构件的一部分能够流体地联接在腿联接区域152,以允许中央连接构件112和多个封装的腿构件106之间的流体连通。第一连接封装构件和第二连接封装构件可由单片材料或如所说明的多于一片的材料界定。
如以上所讨论的,中央连接构件112能够与歧管122流体连通。在一个方面中,类似于以上所讨论的穿孔的穿孔118能够允许流体连通。另外地或可选地,第一连接封装构件的一部分或多个部分能够暴露于歧管122。
现在参考图1A-1D,多个封装的腿构件106中的每个可包括腿歧管构件160,腿歧管构件160可以是在腿模块156和/或中央连接构件112之间延伸的单一式歧管构件,或者是分别的歧管部件。腿歧管构件160被布置在每个封装的腿构件106的内部部分162内。每个腿歧管构件160具有第一侧164和面向内(面向患者)的第二侧166。
在一个实施方式中,多个腿歧管构件160中的一个或多个可具有不同的材料特性或结构。例如,在不同的封装的腿构件106中不同的流速可能是合乎需要的。在一个方面中,不同的歧管材料或歧管特性、不同的歧管尺寸、歧管压缩、阀和/或限制材料结构的使用流量能够提供不同流速的流体穿过封装的腿构件和/或中央连接构件。
在一个方面中,可形成有穿孔114的第一腿封装构件168被布置在腿歧管构件160的第一侧164上。可包含有穿孔116的第二腿封装构件170被布置在腿歧管构件160的面向内的第二侧166上。第二腿封装构件170可以是非粘性盖布148的一部分。在一个实施方式中,封装的腿构件106例如通过盖布148可以彼此配合。可选地,腿构件相对于彼此能够是独立地可移动的,除了相邻于中央连接构件112的它们的近端之外。例如,腿构件不需要被彼此连接。在另一个实施方式中,连接腿构件的一部分材料例如相邻腿构件106之间的非粘性盖布148是可膨胀的(例如可伸展的、柔性的、可变形的和/或弹性的材料)并且允许各个腿构件106相对于彼此的运动。
如图1B的纵截面中箭头172所示,流体能够从腿模块156朝向中央连接构件112流动。如箭头174所示,流体能够进入穿孔114和116并流入腿歧管构件160,然后如箭头172所示流向中央连接构件112。
在平面图中,封装的腿构件106可采用多种不同的形状,例如细长形、矩形、椭圆形等。在一个方面中,封装的腿构件106可包括腿模块156。相邻的腿模块156流体地联接至彼此并且其间具有操纵区158。在一个方面,操纵区包括削弱的或穿孔的区域,以便于为设备设置尺寸。例如,临床医生可切割腿模块来为设备设置尺寸。通过拉部分切割的腿模块,歧管能够在下一个操纵区被扯开。在一个方面中,操纵区158的凹陷形状能够抑制另外的腿模块的意外移除。另外地或可选地,腿模块的外部部分可被固定至设备,以抑制不希望的歧管移除。
封装的腿构件106也可具有各种尺寸。如果封装的腿构件106的较长尺寸例如沿长度方向或纵向的尺寸是L1且宽度是W1,则长宽比为L1/W1。该长宽比可以是8.0、7.0、6.0、5.0、4.0、3.0、2.0或介于中间的任何数值。而且,其它的长宽比也是可以的。一般地,封装的腿构件的宽度W1比中央连接构件的宽度W2小,即W2>W1。例如,在一个说明性实施方式中,封装的腿构件106近似为270mm长、60mm宽(W1)和10mm厚,而中央连接构件具有大约130mm(W2)的平行于第一宽度(W1)的宽度。因此,在该说明性的示例中,封装的腿构件106的长宽比近似为(270/60)或4.5。在该相同的实施方式中,操纵区158具有大约10mm的宽度。
参考图1C,示出了封装的腿构件106的一部分的侧向截面。如前所述,可以看出,腿歧管构件160的第一侧164被第一腿封装构件168覆盖,且腿歧管构件160的面向内的第二侧166被第二腿封装构件170覆盖,第二腿封装构件170在该情况中是非粘性盖布148的一部分。因此,在该说明性实施方式中,穿孔116可以是非粘性盖布148中的多个穿孔150中的一些。在该说明性实施方式中,腿歧管构件160的外围边缘176也被第一腿封装构件168的一部分覆盖。外围边缘176包括第一侧向边缘177和第二侧向边缘179。第一腿封装构件168覆盖第一侧164和外围边缘176,并且延伸到非粘性盖布148的第一表面178上并形成延伸部180。延伸部180通过焊缝182被联接至第二腿封装构件170。然而,可使用包括焊接(例如超声焊或射频焊)、胶合、粘合剂、接合剂等的任何已知技术将第一腿封装构件168联接至第二腿封装构件170。
再次参考图1D和图2,中央连接构件112包括被封装在第一连接封装构件186内的连接歧管构件154,第一连接封装构件186具有穿孔118。第一连接封装构件186被布置在连接歧管构件154的第一侧188上。第二连接封装构件192被布置在连接歧管构件154的面向内的第二侧190上。第二连接封装构件192形成有穿孔120。第一连接封装构件186具有如图2中所示的外围区或边缘194。以相似的方式,第二连接封装构件192具有与外围边缘194排成行的外围区或边缘(未明显示出)。第一连接封装构件186的外围边缘194被联接至第二连接封装构件192的外围边缘,除了在腿联接区域152处之外,以允许多个封装的腿构件106内的流体如图1D中箭头196所示流入连接歧管构件154中。如箭头198所示,流体通过流过穿孔120也可直接进入连接歧管构件154。歧管122邻近第一连接封装构件186布置,且当减压被施加至歧管122时,如箭头200所示,减压引起流体穿过穿孔118流出连接歧管构件154并进入歧管122。流体继续流向减压接驳体128的方向,通过减压接驳体128,流体被移至减压输送导管130。
参考图1A-1D和图2,在操作中,如有关图3A的下面将被进一步解释的,通过首先为处理设备102设置尺寸,说明性开腔式减压系统100可被使用。具有多个封装的腿构件106的非粘性盖布148穿过体腔开口126被布置在腹腔内并抵着腹部内容物被分配;这可包括放置至少一个封装的腿构件106于第一结肠沟108、第二结肠沟110中或邻近第一结肠沟108、第二结肠沟110处或在肝后面等。一旦处理设备102被分配,歧管122即被放置成邻近第一连接封装构件186的第一侧184。然后,密封构件124可被施加在体腔开口126的上方以在体腔开口126的上方提供气动密封。
除了密封构件124之外,还可使用例如U形钉的机械闭合装置或使用减压闭合系统来闭合或加固体腔开口126。密封构件124可以多种方式被应用,但根据一个说明性实施方式,移除处在密封构件124的粘性层136上的可释放的背衬构件(releasable backing member),然后抵着体腔开口126周围的患者表皮134放置密封构件124。然后将例如口138的减压接驳体128附接至密封构件124,以使减压能通过接驳体128被传送、穿过密封构件124并到达歧管122。减压输送导管130被流体地联接至减压接驳体128并被流体地联接至减压源132上的减压口144。
减压源132被启动并由此向减压输送导管130中提供减压,减压输送导管130将减压输送至减压接驳体128并送入歧管122中。歧管122分配减压并通过穿孔118从连接歧管构件154汲取流体。连接歧管构件154通过穿孔120从腹腔汲取流体并且如箭头196所示从多个封装的腿构件106牵引流体。流体通过第一腿封装构件168上的穿孔114并通过第二腿封装构件170上的穿孔116从腹腔流入多个封装的腿构件106,然后如箭头172所示穿过腿流向连接歧管构件154。然后,流体流动穿过歧管122、减压接驳体128并流入减压输送导管130。
现在参考图3A-3C,示出了开腔式减压处理设备302的另一个说明性实施方式。开腔式减压处理设备302在大部分方面类似于图1A-1D的处理设备102。开腔式减压处理设备302具有非粘性盖布304、多个封装的腿构件306和中央连接构件308。在该特定的说明性实施方式中,非粘性盖布304大体上形成为椭圆形或弓形形状。非粘性盖布304形成有多个穿孔305。非粘性盖布304形成第二腿封装构件(通过类比而参见图1B中第二腿封装构件170)和第二连接封装构件(通过类比而参见图1D中192)。因而,多个穿孔305充当用于多个封装的腿构件306和中央连接构件308的面向内的第二侧上的流动通道。非粘性盖布304还能用在多个封装的腿构件306和中央连接构件308的第一侧上。
每个封装的腿构件306可形成有多个腿模块310,且在多个腿模块310之间具有操纵区312。与图1A-D中的操纵区158一样,操纵区312便于多个封装的腿构件306在体腔内的运动,并且提供在开腔式减压处理设备302被设置尺寸而用于特定应用时更容易切割多个封装的腿构件306的位置。在这点上,可在非粘性盖布304上添加可视标记314,以帮助健康护理提供者了解对于在腔内不同尺寸的应用来说在什么地方切割非粘性盖布304。可视标记314可包括切割线或刻度,切割线或刻度优选地延伸穿过操纵区312。操纵区312提供了便利的且容易的位置以用于切割开腔式减压处理设备302。
参考图3C,示出了封装的腿构件306的一部分的侧向截面。多个封装的腿构件306形成有具有第一侧320和面向内(面向患者)的第二侧322的腿歧管构件318。第一腿封装构件324覆盖腿歧管构件318的第一侧320并覆盖腿歧管构件318的侧向区或边缘326。腿歧管构件318的面向内的第二侧322被第二腿封装构件328覆盖,在该实施方式中,第二腿封装构件328是非粘性盖布304的一部分。通过本领域中已知的方法例如焊接(例如超声或射频)、胶合、粘合剂、接合剂等,将第一腿封装构件324联接至第二腿封装构件328。在该说明性实施方式中,第一腿封装构件324和第二腿封装构件328通过焊缝330联接。参考图3B,焊缝330沿着多个腿模块310的周边被示出。
参考图3A,中央连接构件308类似于图2中的中央连接构件112而被形成。使用焊缝333或例如前面提到的那些的另一种联接技术将中央连接构件308的第一连接封装构件334和第二连接封装构件沿着外围边缘332联接。然而,外围边缘332在邻近每个封装的腿构件306处没有被密封,以提供用于使流体从多个封装的腿构件306流入中央连接构件308的通道。
根据用于构造开腔式减压处理设备302的一个说明性方法,已经形成有多个穿孔305且具有可视标记314的非粘性盖布304被提供。腿歧管构件318相邻于非粘性盖布304而布置。中央连接构件308相邻于腿歧管构件318而布置或可与腿歧管构件318整体地形成。第一连接封装构件334放置在中央连接构件308上,且第一腿封装构件324放置在腿歧管构件318的上方。第一连接封装构件334和第一腿封装构件324可由整体式片而形成。接着,应用焊缝330和333。
在用于制造开腔式减压处理设备的可选的实施方式中,可提供包括穿孔的第一非粘性盖布304,并且将腿歧管构件318和中央连接构件308布置在第一非粘性盖布304上。具有穿孔的第二非粘性盖布被放置在第一非粘性盖布304、腿歧管构件318和中央连接构件308上。接着,例如焊缝330的多个焊缝(例如,所使用的热或射频或另一些联接技术)被实施。可在组装之前或组装之后切割第一非粘性盖布304和第二非粘性盖布以设置尺寸。通过使用两个盖布,第一非粘性盖布304和第二非粘性盖布可提供更好的减压分配并且可使制造过程变得容易。
穿孔可在组装之前或组装之后形成。第一非粘性盖布304和第二非粘性盖布的周边可被焊接。盖布之间的其它位置可被焊接以形成一个单元。在另一个可选的实施方式中,最初可放置并焊接没有穿孔的盖布,然后向盖布添加穿孔以使穿孔排成行。还可使用电构件形成穿孔,该电构件同时切割并密封以形成穿过两个盖布的排成行的“钮扣孔”穿孔。
现在参考图4,示出了开腔式减压处理设备402的另一个说明性实施方式。开腔式减压处理设备402相似于图2中的处理设备102,并且为了表示类似的部分,参考数字已经用300加索引。开腔式减压处理设备402基本不同在于包括流体输送子系统445。多个封装的腿构件406显示为不具有腿模块,且穿孔显示为圆形。如前面所提到的,多个封装的腿构件406可被形成为具有或不具有腿模块。流体输送子系统445允许例如药物或冲洗液的各种流体被输送至腔中。然后,被输送的流体可被开腔式减压处理设备402移除。流体输送子系统445包括可被放置在中央连接构件412上或放置在中央连接构件412中的中央口447,用于连接至使流体从外部位置输送至中央口447的导管(未示出)。多个流体输送导管449被流体地联接至中央口447。多个流体输送导管449可位于非粘性盖布448上的任何位置,但在该说明性实施方式中,被布置在多个封装的腿构件406中。多个流体输送导管449在它们的远端451上是敞开的,以允许流体穿过远端451的输送。穿过多个流体输送导管449的远端451的流体流动如箭头453所示。
在使用中,开腔式减压处理设备402可以以与处理设备102和302的方式类似的方式被使用,但在不同的时期或甚至连续地,输送流体穿过流体输送子系统445可能是合乎需要的。例如,使用冲洗液冲洗腹腔或输送药物的周期性剂量可能是合乎需要的。
现在将示出用于使用开腔式减压处理设备(例如腔式减压处理设备102、302、402)或系统的另一个说明性实施方式。该系统特别地适合于这样的腹壁开口的临时桥接,在该腹壁开口处基本闭合可能无法快速地实现和或反复的腹部进入是必须的。本文所描述的说明性系统可与具有露出的内脏的包括但不限于腹腔间隔室综合症的打开的腹部伤口一起使用。在应用该系统之前,通常应能够实现止血。
在配置开腔式减压处理系统中,减压处理设备优选地覆盖所有露出的内脏并且优选地完全分离内脏而不与腹壁接触。例如,减压处理设备的下表面如盖布148能够被设置尺寸并被成形以允许覆盖。减压处理设备可被放置在网膜或露出的内部器官的上方,并被小心地塞在腹壁和内部器官之间。在这样的操作中,健康护理提供者可使用减压处理设备以使腹壁与内部器官完全分离。
为给系统的配置做准备,任何的尖锐边缘或骨碎片被覆盖或从伤口区域被去除。冲洗腹部伤口并且清理干净伤口周围(periwound)。在进一步的应用之前通常先干燥在表皮处的伤口周围组织。
然后,通过确定适当的尺寸和切割,减压处理设备被设置尺寸。减压处理设备在消毒区中最初是展开的。可将减压处理设备的每一侧放置在网膜或内脏上。减压处理设备轻轻地被放置在打开的腹腔上方。确定用于具体应用的减压处理设备的方位。如果减压处理设备围绕管、导液管或镰状韧带放置,则仅在多个封装的腿构件之间切割减压设备。在切割之前,将减压处理设备放置在适当方位中。
然后,减压处理设备被折叠以设置尺寸并且被以该方式使用或可被切割。健康护理提供者通过边缘握住减压处理设备并且轻微地举起减压处理设备。用一只手缓慢地将减压处理设备放低至结肠沟中,并用另一只手轻轻地且平稳地使减压处理设备放下去。健康护理提供者折叠起减压处理设备的任何多余部分并且折叠在减压处理设备本身上。健康护理提供者继续将减压处理设备放置在腹壁和内部器官之间,贯穿腹部间隔室。健康护理提供者优选地提供所有内脏的完全覆盖。然后,可根据为伤口外部设置尺寸的所需来切割减压处理设备。
为给设备设置尺寸,使用消毒剪刀穿过大歧管方块或腿模块之一的中心来切割减压处理设备。在该说明性实施方式中,切割不是穿过操纵区来进行的,而是穿过腿模块。然后,健康护理提供者用一只手捏着泡沫方块或腿模块以及穿过封装构件的相邻的内侧操纵区的剩余一半,并牵引歧管材料。在腿模块和操纵区中的歧管材料将在下一个方块或腿模块处分离。这将保证减压处理设备的边缘覆盖其它露出的歧管边缘。例如泡沫的歧管材料优选地不接触器官。
接下来准备被放置在中央连接构件的顶部上的歧管。在该实施方式中,歧管可以是具有穿孔以帮助将歧管撕扯成所需尺寸的被穿孔的泡沫歧管。歧管优选地直接配合在减压处理设备上方,同时仍与伤口边缘接触。歧管不应接触未受损伤的皮肤。在某些情况中,可使用两个或更多个歧管。然后,被设置尺寸的歧管被轻轻地放入减压处理设备上方的伤口腔中。健康护理提供者优选地小心以避免歧管位于腹部切口或伤口平面的下方。
然后应用盖布或上盖布。为应用盖布,从盖布一侧上的粘性层移除背衬并应用盖布。盖布覆盖未受损伤的表皮的一部分和歧管。优选地,盖布覆盖未受损伤的伤口周围组织的至少8-10厘米的边界。可添加另外的盖布材料以密封任何难弄的区域。
然后添加减压接驳体或接驳垫。健康护理提供者选择应用部位。该部位被选择以使流体流动最佳以及便于容易的管定位。健康护理提供者捏着盖布并穿过盖布切割2.5cm的洞(优选地不是狭长的切口)。应用接驳垫,该接驳垫具有中央盘和环绕的外部粘性裙边。通过移除接驳垫的面向内的表面上的背衬层以露出粘合剂来应用接驳垫。将中央盘中的接驳垫开口直接放置在盖布中的洞的上方。在中央盘和外部裙边上轻轻施加压力,以保证接驳垫的完全粘合。然后可从裙边的第一侧移除一个或多个稳定层。系统现在准备用于施加减压。
根据图5中所示的另一个说明性实施方式,开腔式减压处理设备502包括中央流体毂状物512和多个细长构件506。中央流体毂状物512具有上表面513和下表面。中央流体毂状物512包括界定上表面513的至少一部分的泡沫歧管554和界定所述下表面的至少一部分的基本上流体不能渗透的壁。流体不能渗透的壁包括多个孔518。多个细长构件506具有近端515、远端517以及上表面519和下表面。细长构件506包括被封闭在基本上流体不能渗透的壁内的泡沫。多个细长构件506的近端515与中央流体毂状物512流体连通。细长构件506包括沿着细长构件506的下表面的至少一部分延伸穿过流体不能渗透的壁的孔514。
多个细长构件506具有从中央流体毂状物512延伸的第一长度L1和大体上平行于上表面且垂直于第一长度的第一宽度(W1)。中央毂状物具有在第一细长构件和第二细长构件之间的部分上的侧向边缘之间的第二宽度(W2)。第二宽度大于第一宽度(W2>W1)。多个细长构件506流体地联接至中央毂状物512。开腔式减压处理设备502可具有在3.0至10.0范围中的多个细长构件506的长宽比。开腔式减压处理设备502可具有大于3.5的多个细长构件506的长宽比。开腔式减压处理设备502还可包括在多个细长构件506之间延伸的弹性材料585。
虽然在某些说明性、非限制性的实施方式的情况中已公开了本发明和它的优势,但应理解,可以进行不同的改变、替换、置换和变更而不偏离如所附的权利要求所限定的本发明的范围。应理解,相关于任何一个实施方式所描述的任何特征对于任何其它的实施方式也适用。
Claims (5)
1.一种开腔式减压处理设备,包括:
中央流体毂状物,其具有上表面和下表面,所述中央流体毂状物包括界定所述上表面的至少一部分的泡沫歧管和界定所述下表面的至少一部分的基本上流体不能渗透的壁,所述流体不能渗透的壁包括多个孔,
多个细长构件,其具有近端和远端以及上表面和下表面,所述多个细长构件包括被封闭在基本上流体不能渗透的壁内的泡沫,所述多个细长构件的所述近端与所述中央流体毂状物流体连通,所述多个细长构件包括沿着所述多个细长构件的所述下表面的至少一部分延伸穿过所述流体不能渗透的壁的孔,
其中,所述多个细长构件具有从所述中央流体毂状物延伸的第一长度L1和大体上平行于所述多个细长构件的所述上表面的第一宽度(W1),
其中,所述中央流体毂状物具有在第一细长构件和第二细长构件之间的第二宽度(W2);
其中,所述第二宽度大于所述第一宽度(W2>W1)。
2.根据权利要求1所述的开腔式减压处理设备,其中,所述多个细长构件的长宽比(L1比W1)处在3.0至10.0的范围中。
3.根据权利要求1所述的开腔式减压处理设备,其中,所述多个细长构件的长宽比大于3.5。
4.根据权利要求1所述的开腔式减压处理设备,还包括在所述多个细长构件之间延伸的基本上流体不能渗透的材料。
5.根据权利要求1所述的开腔式减压处理设备,还包括在所述多个细长构件之间延伸的可膨胀的材料。
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110446477A (zh) * | 2017-04-04 | 2019-11-12 | 埃埃特鲁医疗有限责任公司 | 负压装置和方法 |
CN110446477B (zh) * | 2017-04-04 | 2022-03-29 | 埃埃特鲁医疗有限责任公司 | 负压装置和方法 |
CN110831553A (zh) * | 2017-06-07 | 2020-02-21 | 凯希特许有限公司 | 用于通过负压治疗来改善肉芽生长和减少泡软的复合敷料 |
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