CN102046118B - 具有可膨胀的囊的伤口敷料及制造方法 - Google Patents
具有可膨胀的囊的伤口敷料及制造方法 Download PDFInfo
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- CN102046118B CN102046118B CN200980119147XA CN200980119147A CN102046118B CN 102046118 B CN102046118 B CN 102046118B CN 200980119147X A CN200980119147X A CN 200980119147XA CN 200980119147 A CN200980119147 A CN 200980119147A CN 102046118 B CN102046118 B CN 102046118B
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- expandable capsule
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- decompression
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Abstract
一种用于向患者的组织部位(102)提供减压治疗的系统包括：用于供给减压的减压源(107)、用于供给流体的流体源(116)和用于邻近组织部位放置的多个可膨胀的囊(108)。可膨胀的囊(108)可操作来接收流体以从未膨胀位置膨胀到膨胀位置。该系统还包括可压缩的多个室(120)。多个室中的至少一个被置于多个可膨胀的囊中的第一可膨胀的囊与第二可膨胀的囊之间。
Description
相关申请
根据35U.S.C.§119(e)，本发明要求享有下述专利申请的权益：2008年5月30日提交的美国临时专利申请系列第61/057,807号，题目为“减压外科伤口治疗系统(Reduced-pressure Surgical Wound Treatment System)”；2008年5月30日提交的美国临时专利申请系列第61/057,798号，题目为“使用减压用于皮下伤口治疗的敷料组件(Dressing Assembly For Subcutaneous Wound treatment Using Reduce Pressure)”；2008年5月30日提交的美国临时专利申请系列第61/057,808号，题目为“透视的减压敷料(See-Through，Reduced-Pressure Dressing)”；2008年5月30日提交的美国临时专利申请系列第61/057,802号，题目为“用于施加封闭力的减压敷料组件(Reduced-Pressure Dressing Assembly For Use in Applying a Closing Force)”；2008年5月30日提交的美国临时专利申请系列第61/057,803号，题目为“减压、线性伤口治疗系统(Reduced-Pressure，Linear-Wound Treatment System)”；2008年5月30日提交的美国临时专利申请系列第61/057,800号，题目为“用于使用在弯曲身体部位上的减压、压缩系统和装置(Reduced-Pressure，Compression System and Apparatus for use on Curved Body Part)”；2008年5月30日提交的美国临时专利申请系列第61/057,797号，题目为“用于使用在胸部组织上的减压、压缩系统和装置(Reduced-Pressure，Compression System and Apparatus for use on Breast Tissue)”；2008年5月30日提交的美国临时专利申请系列第61/057,805号，题目为“超吸收性减压伤口敷料和系统(Super-Absorbent，Reduced-Pressure Wound Dressing and System)”；2008年5月30日提交的美国临时专利申请系列第61/057,810号，题目为“用于使用在关节上的减压、压缩系统和装置(Reduced-Pressure，Compression System and Apparatus for use on a Joint)”；2008年12月10日提交的美国临时专利申请系列第61/121,362号，题目为“采用各向异性的覆盖物的减压伤口治疗系统(Reduced-Pressure Wound treatment System Employing an Anisotropic Drape)”；以及2009年1月12日提交的美国临时专利申请系列第61/144,067号，题目为“用于使用在关节上的减压、压缩系统和装置(Reduced-Pressure，Compression System and Apparatus for use on a Joint)”。
所有这些临时申请基于所有目的在此通过引用并入。
技术领域
本发明通常涉及医学治疗系统，且更具体地说，涉及可膨胀的囊敷料、系统和方法。
背景
临床研究和实践已经表明，在接近组织部位提供减压增加和加速组织部位的新组织的生长。此现象的应用很多，但是减压的应用在治疗伤口中已经特别成功。此治疗(在医疗界中经常被称作“负压伤口治疗”、“减压治疗”或“真空治疗”)提供许多益处，包括更快愈合和增加的肉芽组织的形成。除非另外表示，否则，正如本文中使用的，“或”并不要求相互排除。此外，借助使用其他设备，诸如缝合线、纤维(staple)或有助于闭合伤口的其他设备的额外的护理可以使伤口更快的愈合。
概述
根据示例性的实施方案，一种用于向患者的组织部位提供减压治疗的系统包括：用于供给减压的减压源、用于供给流体的流体源和用于邻近组织部位放置的多个可膨胀的囊。可膨胀的囊可操作来接收流体以从未膨胀位置膨胀到膨胀位置。该系统还包括可压缩的多个室。多个室中的至少一个被置于多个可膨胀的囊中的第一可膨胀的囊与第二可膨胀的囊之间。
在本发明的系统中，当所述可膨胀的囊从所述未膨胀位置膨胀到所述 膨胀位置时，所述室可压缩。
本发明的系统还可包括：覆盖物，其用于当所述可膨胀的囊接近患者的表皮放置时覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室；并且其中，所述室可操作来接收减压，所述减压造成所述室缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的系统还可包括：覆盖物，其用于当所述可膨胀的囊接近患者的表皮放置时覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室；减压导管，其用于输送减压；减压接驳体，其用于连接到所述覆盖物且可操作来提供所述减压导管与所述密封空间之间的流体相通；并且其中，所述室可操作来接收减压且受到减压作用而缩陷。
本发明的系统还可包括：覆盖物，其用于覆盖所述可膨胀的囊以形成接近所述组织部位的密封空间，所述密封空间包括所述室；以及粘合剂，其用于将所述覆盖物的外周连接到患者以促进所述密封空间的密封；并且其中，所述室可操作来接收减压且至少部分地受到减压作用而缩陷。
在本发明的系统中，所述可膨胀的囊和所述室可形成有顶壁、底壁和柔性的侧壁，且所述柔性的侧壁的至少一部分可将所述可膨胀的囊与所述室分隔；并且所述室可操作来接收减压，所述室可操作以在减压作用下缩陷并使所述可膨胀的囊彼此更靠近地移动。
在本发明的系统中，所述可膨胀的囊和所述室可形成有顶壁、底壁和柔性的侧壁，且所述柔性的侧壁的至少一部分可将所述可膨胀的囊与所述室分隔；所述室可操作来接收减压且受到减压作用而缩陷并可使所述可膨胀的囊彼此更靠近地移动；并且当所述可膨胀的囊处于所述未膨胀位置时，所述可膨胀的囊中的每一个可具有大体矩形的横截面形状，且在不存在减压时，所述室的每一个可具有大体矩形的横截面形状。
本发明的系统还可包括：第一片；以及第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管用于提供所述可膨胀的囊之间的流体相通。
本发明的系统还可包括：第一片；和第二片，其连接到所述第一片以 形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；并且其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的系统还可包括：第一片；第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；双管腔导管，其流体地连接至所述减压源和所述流体源，所述双管腔导管具有用于输送减压的第一管腔和用于输送流体的第二管腔；接驳体，其用于流体地连接至所述多个室和所述减压源以及流体地连接至所述流体源和所述多个可膨胀的囊，所述接驳体可操作来输送减压和流体；并且其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的系统还可包括：第一片；以及第二片，其被沿着焊接线焊接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
在本发明的系统中，所述可膨胀的囊中的至少一个可膨胀的囊可包括：支柱，其用于当所述至少一个可膨胀的囊被膨胀时，将所述至少一个可膨胀的囊限制成沿着一个方向膨胀。
本发明的系统还可包括：流体导管，其用于提供所述流体源与所述可膨胀的囊之间的流体相通；以及流体接驳体，其将所述流体导管流体地连接至所述可膨胀的囊。
本发明的系统还可包括：分配导管，其用于提供所述可膨胀的囊之间的流体相通。
本发明的系统还可包括：分配导管，其用于提供所述可膨胀的囊之间的流体相通，其中，所述分配导管是波纹状的以促进所述可膨胀的囊的移动。
在本发明的系统中，所述可膨胀的囊中的每一个在处于所述膨胀位置时可以是大体圆柱形的，并且所述可膨胀的囊彼此可以是大体平行的。
在本发明的系统中，所述可膨胀的囊可形成同心的环。
在本发明的系统中，所述室可操作来接收减压，所述减压造成所述室缩陷并使所述可膨胀的囊彼此更靠近地移动，使得闭合力施加到所述组织部位处的伤口。
根据另一个示例性的实施方案，装置包括用于邻近组织部位放置的多个可膨胀的囊。可膨胀的囊可操作来接收流体且从未膨胀位置膨胀到膨胀位置。该系统还包括可压缩的多个室。多个室中的至少一个被置于多个可膨胀的囊中的第一可膨胀的囊与第二可膨胀的囊之间。
在本发明的装置中，当所述可膨胀的囊从所述未膨胀位置膨胀到所述膨胀位置时，所述室可压缩。
本发明的装置还可包括：覆盖物，其用于覆盖所述可膨胀的囊以形成接近患者的多个密封空间，所述密封空间包括所述室；并且其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的装置还可包括：覆盖物，其用于覆盖所述可膨胀的囊以形成接近患者的多个密封空间，所述密封空间包括所述室；减压导管，其用于输送减压；减压接驳体，其用于流体地连接所述减压导管与所述多个密封空间；并且其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的装置还可包括：覆盖物，其用于覆盖所述可膨胀的囊以形成多个密封空间，所述密封空间包括所述室；粘合剂，其用于将所述覆盖物的外周连接到患者以促进所述密封空间的密封；并且其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
在本发明的装置中，所述可膨胀的囊和所述室可形成有顶壁、底壁和柔性的侧壁；并且所述室可操作来接收减压且缩陷，由此可使所述可膨胀的囊彼此更靠近地移动。
在本发明的装置中，所述可膨胀的囊和所述室可由顶壁、底壁和柔性的侧壁形成；所述室可操作来接收减压且缩陷并可使所述可膨胀的囊彼此更靠近地移动；并且当所述可膨胀的囊处于所述未膨胀位置时，所述可膨胀的囊中的每一个可具有大体矩形的横截面形状，且在不存在减压时，所述室的每一个可具有大体矩形的横截面形状。
本发明的装置还可包括：第一片；以及第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
本发明的装置还可包括：第一片；和第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；并且其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的装置还可包括：第一片；第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；减压源，其用于供给减压；流体源，其用于供给流体；双管腔导管，其流体地连接至所述减压源和所述流体源，所述双管腔导管具有用于输送减压的第一管腔和用于输送流体的第二管腔；接驳体，其用于流体地连接至所述多个室和所述减压源以及流体地连接至所述流体源和所述多个可膨胀的囊，所述接驳体可操作来输送减压和流体；并且其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
本发明的装置还可包括：第一片；以及第二片，其被沿着焊接线焊接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
在本发明的装置中，所述可膨胀的囊中的至少一个可膨胀的囊可包括：支柱，其用于当所述至少一个可膨胀的囊被膨胀时，将所述至少一个可膨胀的囊限制成沿着一个方向膨胀。
本发明的装置还可包括：流体源，其用于供给流体；流体导管，其用于提供所述流体源与所述可膨胀的囊之间的流体相通；以及流体接驳体，其将所述流体导管流体地连接至所述可膨胀的囊。
本发明的装置还可包括：分配导管，其用于提供所述可膨胀的囊之间的流体相通。
本发明的装置还可包括：分配导管，其用于提供所述可膨胀的囊之间的流体相通，其中，所述分配导管是波纹状的以促进所述可膨胀的囊的移 动。
在本发明的装置中：所述可膨胀的囊中的每一个在处于所述膨胀位置时可以是大体圆柱形的，并且所述可膨胀的囊彼此可以是大体平行的。
在本发明的装置中，所述可膨胀的囊可形成同心的环。
在本发明的装置中，所述室可操作来接收减压，所述减压造成所述室缩陷并可使所述可膨胀的囊彼此更靠近地移动，使得闭合力施加到所述组织部位处的伤口。
根据另一个示例性的实施方案，一种用于向患者的组织部位提供减压处理的方法包括向组织部位应用多隔室敷料(multi-compartment dressing)。多隔室敷料包括用于邻近组织部位放置的多个可膨胀的囊。可膨胀的囊可操作来接收流体且从未膨胀位置膨胀到膨胀位置。多隔室敷料还包括可压缩的多个室。多个室中的至少一个被置于多个可膨胀的囊中的第一可膨胀的囊与第二可膨胀的囊之间。当可膨胀的囊膨胀到膨胀位置时或当将减压供给至室时，室被压缩。该方法还包括将流体应用至可膨胀的囊以使可膨胀的囊膨胀至膨胀位置，以及经由多隔室敷料将减压应用至组织部位。
在本发明的方法中，当所述可膨胀的囊膨胀至所述膨胀位置时，所述室可被压缩。
本发明的方法还可包括：向所述室施加减压以造成所述室缩陷，使得所述可膨胀的囊彼此更靠近地移动。
在本发明的方法中，向所述组织部位应用所述敷料的步骤还可包括：用覆盖物覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室。
根据另一个示例性的实施方案，一种制造方法包括形成多个可膨胀的囊且形成多个室的步骤。该方法还包括连接多个可膨胀的囊和多个室。可膨胀的囊可操作来接收流体且从未膨胀位置膨胀到膨胀位置。
本发明的制造方法还可包括：提供分配导管；以及使用所述分配导管将所述可膨胀的囊彼此流体地连接。
本发明的制造方法还可包括：提供分配导管；使用所述分配导管将所 述可膨胀的囊彼此流体地连接；以及提供覆盖物，所述覆盖物适合于覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室。
在本发明的制造方法中，形成所述可膨胀的囊的步骤可包括：提供第一片；提供第二片；以及将所述第一片连接到所述第二片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
在本发明的制造方法中，形成所述可膨胀的囊的步骤可包括：提供第一片；提供第二片；以及将所述第一片沿着焊接线焊接到所述第二片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
在本发明的制造方法中，形成所述可膨胀的囊的步骤可包括：形成顶壁、底壁和将所述顶壁连接到所述底壁的柔性的侧壁。
附图描述
图1是根据示例性实施方案的用于向患者提供减压治疗的系统的示意图，其中敷料由俯视图显示；
图2A是图1中显示的具有处于未膨胀位置的可膨胀的囊的敷料的示意性横截面图；
图2B是图1中显示的具有处于膨胀位置的可膨胀的囊的敷料的示意性横截面图。
图2C是图1中显示的具有处于膨胀位置的可膨胀的囊且减压施加到可膨胀的囊之间的室的敷料的示意性横截面图；
图3是图1中显示的可膨胀的囊的示意性透视图；
图4A是根据示例性实施方案的具有支柱且显示为处于未膨胀位置的可膨胀的囊的示意性横截面图；
图4B是图4A的处于膨胀位置的可膨胀的囊；
图5是用于提供减压治疗的系统的一部分的另一个示例性实施方案的示意性透视图；
图6是根据示例性实施方案的具有可膨胀的囊和可膨胀的囊之间的室的平面结构的示意性俯视图；
图7A是图6中的平面结构的沿线7A-7A取的示意性横截面图；
图7B是图7A中显示的具有处于膨胀位置的可膨胀的囊，同时减压被施加到可膨胀的囊之间的室的平面结构的示意性横截面图；
图8是具有可膨胀的囊和室的敷料的另一个示例性实施方案的示意性俯视图；
图9A是图8中显示的沿线9A-9A取的敷料的示意性横截面图；
图9B是图9A中显示的具有处于膨胀位置的可膨胀的囊的敷料的示意性横截面图；以及
图10是图8中显示的沿线10-10取的敷料的示意性横截面图。
详述
在下面示例性实施方案的详述中，参照构成优选实施方案的一部分的附图。这些实施方案被充分详细地描述，以使本领域的技术人员能够实践本发明，而且应该理解到，可使用其他实施方案，并可做出逻辑结构、机械、电及化学变化，而并不偏离本发明的精神或范围。为避免对使本领域技术人员能够实践于此描述的实施方案来说不必要的细节，描述可省略对本领域技术人员熟知的某些信息。因此，以下详细描述不应理解为限制性意义，并且示例性实施方案的范围仅由所附权利要求界定。
现在参考图1、2A-2C和3，显示了用于向患者104的组织部位102应用减压治疗的系统100的示例性实施方案。减压治疗可以包括减压疗法或减压产生的闭合力。系统100包括多隔室敷料106，减压从减压源107供给至多隔室敷料106，且流体可以从流体源116供给。
减压源107可以是用于供给减压的任何设备，诸如真空泵、墙式抽吸装置(wall suction)或其他源。虽然施加到组织部位的减压的量和性质通常将根据应用来改变，但是减压通常在-5mm Hg到-500mm Hg之间，且 更通常在-100mm Hg到-300mm Hg之间。
正如本文中使用的，“减压”一般指作在受到治疗的组织部位处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位置的大气压力。可选择地，减压可小于组织部位处的流体静压。除非另外表明，否则本文中所述的压力值是表压。输送的减压可以是恒定的或变化的(图案化的或随机的)并且可以连续地输送或间歇地输送。尽管术语“真空”和“负压”可以用于描述施加到组织部位的压力，但是施加到组织部位的实际压力可能大于通常与绝对真空相关的压力。与本文中使用的一致，减压或真空压力的增加通常指绝对压力的相对减少。
多隔室敷料106包括可以通过一个或多个分配导管110彼此流体连接的可膨胀的囊108。可膨胀的囊108还包括接驳体112，流体供给导管114可以流体连接至接驳体112，使得可以通过流体源116将流体供给至可膨胀的囊108。正如此处使用的，术语“连接”包括经由不同物体的连接且包括直接连接。术语“连接”还包括借助由相同的材料部件形成的部件中的每一个而彼此是连续的两个或更多个部件。而且，术语“连接”可以包括化学连接，诸如经由化学键，机械连接、热连接或电连接。流体连接意指流体在指定的部件或位置之间是相通的。
多隔室敷料106还包括覆盖可膨胀的囊108以形成多个室120的覆盖物(drape)118。室120被设置在每一对可膨胀的囊108之间。因而，形成多隔室，如可膨胀的囊108和室120。当覆盖物118覆盖可膨胀的囊108并密封贴着患者的表皮125时，覆盖物118形成密封空间122，可膨胀的囊108位于密封空间122内。覆盖物118可以是提供流体密封的任何材料。覆盖物118可以是，如可渗透的或可半渗透的弹性材料。“弹性”意指具有弹性体的性能。弹性通常指的是具有类似橡胶的性能的聚合物材料。更具体而言，大多数弹性体具有大于100％的拉伸速率和显著量的回弹性。材料的回弹性指的是材料从弹性变形恢复的能力。弹性体的示例可以包括但不限于，天然橡胶、聚异戊二烯、苯乙烯丁二烯橡胶、氯丁二烯橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、三元乙丙橡胶、氯磺化聚乙烯、聚硫橡胶、聚氨基甲酸酯、EVA膜、共聚多酯和硅氧烷。覆盖物118材料 的具体示例包括硅氧烷覆盖物、3M Tegaderm
覆盖物、丙烯酸覆盖物，诸如从Avery Dennison获得的丙烯酸覆盖物或切开覆盖物(incise drape)。
通过将粘合剂124置于覆盖物118的向内的、或面朝组织侧的外周处促进了覆盖物118对患者的表皮125的密封。粘合剂124可以用于使覆盖物118保持贴着患者的表皮125或另一层，诸如衬垫或额外的覆盖物。粘合剂124可以呈多种形式。例如，粘合剂124可以是围绕覆盖物118的外周延伸的医学上可接受的压敏粘合剂124。
覆盖物118还可以包括孔(未显示)，减压接驳体126可以连接到该孔。减压导管128可以连接到减压接驳体126。来自减压源107的减压可以经由减压接驳体126和减压导管128被输送至密封空间122。被输送至多隔室敷料106的减压的一个作用是向组织部位102提供减压治疗。
组织部位102可以是任何人类、动物或其他有机体的身体组织，包括骨组织、脂肪组织、肌肉组织、皮肤组织、血管组织、结缔组织、软骨组织、腱、韧带或任何其他组织。组织部位102的治疗可以包括去除如腹水、渗出物的流体或输送减压。组织部位102可以是伤口129或者包括伤口129。组织部位102上的伤口129可以是由多种原因引起的，包括创伤、外科手术等。
减压导管128的中间部分130可以具有一个或多个设备，诸如设备131。例如，设备131可以是流体储器或收集构件以容纳去除的渗出物和其他流体。可以被包括在减压导管128的中间部分130上的或以其他方式流体连接至减压导管128的设备131的其他示例包括下面的非限制性的示例：压力反馈设备、容积检测系统、血液检测系统、感染检测系统、流动监测系统、温度监测系统等。这些设备中的一些可以整体形成到减压源170。例如，减压源107上的减压端口可以包括过滤器构件，其包括一个或多个过滤器，如臭味过滤器。而且，减压导管128和流体供给导管114可以结合成具有两个或更多个管腔的多管腔导管。
任意数目的可膨胀的囊108可以包括在多隔室敷料106内。可膨胀的囊108可以彼此大体平行。然而，在其他实施方案中，可膨胀的囊108可以相对于彼此具有不同的方位。例如，可膨胀的囊108可以具有径向构型， 波浪图案等。而且，可膨胀的囊108可以由允许可膨胀的囊108膨胀和收缩的任何柔性材料形成。例如，可膨胀的囊108可以由柔软的聚合物或任何其他柔性材料形成。
可以将流体从流体源116供给至可膨胀的囊108，以便使可膨胀的囊从未膨胀位置膨胀到膨胀位置。还可以将减压供给至室120以减少室120的容积或向组织部位102提供减压治疗。图2A-2C显示了多隔室敷料106在不同的时间点的不同状态。在图2A中，可膨胀的囊108处于未膨胀状态且不向室120施加减压。在图2B中，可膨胀的囊108处于膨胀位置且仍不向室120施加减压。在图2C中，可膨胀的囊108处于膨胀位置且向室120施加减压，造成室120缩陷并提供减压治疗。
正如在图2B和2C中显示的，当可膨胀的囊108处于膨胀位置时，其具有较大的内部容积和较大的横截面。随着可膨胀的囊108填充有来自流体源116的流体，相邻的可膨胀的囊108的壁之间的距离也可以减小，由此压缩室120。通过向覆盖物118下的密封空间122施加减压，可以进一步减小室120的容积。当由减压源107施加这种减压时，室120是可缩陷的，使得可膨胀的囊108彼此更靠近地移动。向室120施加减压减小了可膨胀的囊108之间的距离。因而，该距离是在图2B中显示的呈未膨胀部分的d1和在图2C中显示的呈膨胀部分的距离d2且d1＞d2。
特别参考图2C，可膨胀的囊108的彼此相向的运动促进了向内的或闭合力134，这可以有助于闭合或愈合伤口129。可膨胀的囊108的膨胀和室120的压缩促进了多隔室敷料106沿着一个方向整体压缩，该方向诸如由双向箭头138表示的方向。然而，在其他实施方案中，多隔室敷料106可以沿着两个或更多个方向被压缩。可膨胀的囊108的膨胀还可以有助于产生作用到组织部位102上的向下的压缩力136。
可膨胀的囊108被膨胀的量和施加到室120的减压的量可以根据待治疗的组织部位102来调节。例如，通过改变由流体源116供给至可膨胀的囊108的流体的量，可以产生不同量值的向内的力134。类似地，通过调节由减压源107施加到室120的减压的量，可以改变向内的力134的量值。除了改变施加到多隔室敷料106的减压和流体以外，还可以改变多隔室敷 料106的结构而用于不同的治疗类型。例如，可以从图中所显示的改变每一个可膨胀的囊108的横截面积、横截面形状和长度。而且，可膨胀的囊108不需要是均匀的，且相反，每一个可以具有不同的结构且每一个接收不同量的流体，从而将可膨胀的囊膨胀到不同的程度。在类似的方式中，室120的每一个可以接收变化量的减压，由此在每一对可膨胀的囊108之间产生不同的压缩力136。
由图1清楚显示的分配导管110的波纹状结构促进了多隔室敷料106的向内的压缩，且尤其是可膨胀的囊108朝向彼此的压缩。具体地，分配导管110的波纹允许可膨胀的囊以类似手风琴的方式被压缩。分配导管110可以由促进多隔室敷料106发挥作用的任何柔性材料形成。
医护人员可以通过将可膨胀的囊108应用至组织部位102来实施治疗。可以将覆盖物118应用到可膨胀的囊108上，使得覆盖物118覆盖可膨胀的囊108。将减压接驳体126应用到覆盖物118内的孔。接着，将导管128和114分别应用到减压接驳体126和接驳体112。在由减压源107将减压施加到密封空间122之前、过程中或之后，可以由流体源116将流体供给至可膨胀的囊108。以这种方式应用减压和流体有利于组织部位102的治疗。
在其他实施方案中，独立加压的第三囊或室(未显示)可以被包括在多隔室敷料106内。而且，室120也可以接收正压，而不是减压，以产生改变的敷料结构。虽然仅显示了单层的可膨胀的囊108，但是在其他实施方案中，两层或更多层的可膨胀的囊108可以一个堆叠在另一个上。可膨胀的囊108的壁还可以包括刚性结构，诸如刚性的、内嵌的板，以便当处于膨胀位置时改变可膨胀的囊108的形状。流体，包括促进伤口129愈合的愈合和生长因子，可以在减压治疗过程中被引入到室120内。供给到多隔室敷料106的流体和减压水平可以随时间调节，以产生组织部位102的动态负荷。这种调节可以包括空气或其他气体的脉冲或压力波快速吹入。这种调节还可以横跨多隔室敷料106发生，以促使组织部位102内定向的间质流体流动。
现在参考图4A到4B，显示了根据另一个示例性实施方案的可膨胀的 囊208。可膨胀的囊208可以用作用于应用减压治疗的系统(诸如，图1-3中的系统100)的一部分。可膨胀的囊208包括连接到可膨胀的囊208的壁245的支柱240。当可膨胀的囊208处于膨胀位置时，支柱240限制了可膨胀的囊沿着由双向箭头242表示的一个方向进行膨胀。可膨胀的囊208在图4A中显示为处于未膨胀位置，而在图4B中显示为处于膨胀位置。可以将支柱240插入到位于多隔室敷料106内的全部或一部分可膨胀的囊208中。通过限制可膨胀的囊208的膨胀，可以定制施加到组织部位的压缩和其他力以增强组织治疗。
支柱240可以是任何长度且可以任意方式连接到可膨胀的囊208的壁245。例如，支柱240可以在每一端上具有嵌在可膨胀的囊208的壁245内的凸缘244。在其他实施方案中，支柱240在多个方位上被插在可膨胀的囊208内，使得可膨胀的囊208在两个或更多个方向上的膨胀受到限制。
现在参考图5，显示了可膨胀的囊308的另一个示例性实施方案。与图1到3显示的具有在处于膨胀位置时呈大体圆柱形的可膨胀的囊108相比，可膨胀的囊308中的每一个是圆形或环形。可膨胀的囊308形成同心环。
可膨胀的囊308通过分配导管310彼此流体连接，分配导管310是波纹状的以允许可膨胀的囊308彼此相向移动。分配导管310包括接驳体312，流体可以经由供给流体导管而应用到接驳体312。与图1到3中的可膨胀的囊108类似，图5中显示的可膨胀的囊308可以被覆盖物覆盖以形成密封空间，其包括每一对可膨胀的囊308之间的各个室。使用环形可膨胀的囊308可以促进应用了可膨胀的囊308的组织部位处的特定的压缩和愈合特征。例如，可膨胀的囊308沿着多个径向方向346可以是可压缩的。
现在参考图6、7A和7B，呈现了多隔室敷料606的另一个示例性实施方案。多隔室敷料606包括具有可膨胀的囊608和室620的平面结构648。平面结构648由顶壁650和底壁652形成。通过多个柔性的侧壁654将顶壁650和底壁652连接在一起，形成了包括可膨胀的囊608和室620的多个隔室。如图7A所示，当可膨胀的囊608处于未膨胀位置且未向室620应用减压时，可膨胀的囊608和室620都具有大体矩形的横截面。然而， 在其他实施方案中，可膨胀的囊608和室620可以具有其他横截面形状。
通过流体供给导管614将流体供给至可膨胀的囊608。通过减压导管628将减压供给至室620。流体供给导管614和减压导管628的每一个具有分岔结构，因此可以将流体和减压供给至各个可膨胀的囊608和室620。然而，在其他实施方案中，可以仅使用单一流体供给导管614和减压导管628，每一个具有非分叉结构，或可以使用多个单个导管。在不存在这样的分叉结构或单个导管时，可膨胀的囊608可以彼此流体相通且室620的每一个可以彼此流体相通。这样，供给到单个室620的减压可以被输送至平面结构648内的其余的室620。类似地，供给至单个可膨胀的囊608的流体可以被输送至其余的可膨胀的囊608。
图7A显示了因不存在流体供给而处于未膨胀位置的可膨胀的囊608且还显示了不存在减压时的室620。在图7B中，已经将流体供给至可膨胀的囊608，使得可膨胀的囊608处于膨胀位置。此外，已经将减压应用至室620，由此使室620缩陷并使可膨胀的囊608彼此更靠近地移动。已经沿着双向箭头638压缩平面结构648。这种压缩可以向组织部位提供期望的压缩力以增强愈合，正如上面描述的。在一些情况下，平面结构648可以被覆盖物，诸如图1中的覆盖物118覆盖。在可选择的实施方案中，孔可以形成在底壁652上以允许室620内的减压与组织部位相通。虽然可膨胀的囊608和室620显示为彼此是大体平行的，但是可膨胀的囊608和室620可以具有相对于彼此的任何方位且可以具有任何形状。例如，可膨胀的囊608或室620中的任一个或两个可以是同心的环。
现在参考图8到10，显示了敷料806的另一个实施方案，其包括在结合部位860处彼此连接以形成可膨胀的囊808和室820的第一片856和第二片858。虽然在图8中显示为单个可膨胀的囊808和单个室，但是应理解，也可以形成多个囊和室。第一片856和第二片858可以由任何柔性材料制成，包括上面描述的可以形成图1中的覆盖物118的那些材料。第一片856和第二片858沿着线862彼此结合，这通常界定了可膨胀的囊808和室820的边界。通过结合防止了流体流过线862和863。为了促进沿着线862和863的流体不可渗透性，采用任何已知的技术将第一片856结合 到第二片858，这些技术包括但不限于焊接(如超声焊接或RF焊接)、结合、粘合剂或接合剂等。
可膨胀的囊808经由分配导管810与接驳体866流体相通。在敷料806中，由线862的构型也形成分配导管810，第一片856和第二片858结合在线862处。
图9A和9B分别显示了处于未膨胀位置和膨胀位置的可膨胀的囊808。流体通过导管864供给至可膨胀的囊808，关于此点的额外的细节将在下面提供。敷料806可以通过可以位于敷料806的外周865处的粘合剂824粘附到组织部位802。
当将流体供给至可膨胀的囊808时，可膨胀的囊808膨胀至膨胀位置，由此使敷料806沿着组织部位802的表面移动。当可膨胀的囊808膨胀时，敷料806沿着一方向移动，该方向由双向箭头838表示。沿着双向箭头838的收缩力有助于引起向内的或闭合力834，这可以有益于闭合或愈合伤口828。通过粘合剂824将敷料806粘附到组织部位802还可以有助于提供或输送此向内的力834。当可膨胀的囊808处于膨胀位置时，也可以提供沿着箭头836的朝向组织部位802的压缩力。
在由图8到10表示的实施方案中，室820未受到减压以使室820缩陷。然而，当可膨胀的囊808处于膨胀位置时，室820确实提供了沿着可膨胀的囊808可以彼此更靠近地移动的空间区域。然而，在其他实施方案中，可以将减压施加到室820。而且，在一个实施方案中，可以将减压输送至室820且孔可以形成在敷料806的底部上，这允许室820内的减压与组织部位802相通。
可以通过连接到接驳体866的多管腔导管864将流体和减压供给至敷料806。接驳体866可以被置于穿过第一片856和第二片858的孔868内。
多管腔导管864包括至少流体管腔870和减压管腔872。接驳体866被构造成给穿过流体管腔870输送的流体定路线至分配导管810，分配导管810将流体输送至可膨胀的囊808。接驳体866还被构造成从减压管腔872输送减压穿过第一片856和第二片858上的孔并至敷料806的面朝组 织侧874；这样，将包括气体的流体从敷料806的面朝组织侧874抽吸到减压管腔872内。当行进穿过敷料806时，减压可以由诸如用于组织部位或伤口的垫枕(bolster)或歧管的另一个结构接收。导管864的多管腔结构和接驳体866的定路线功能允许使用单一多管腔导管864将减压和流体供给至敷料806。
在其他实施方案中，通过接驳体866可以将减压供给至室820。而且，诸如管的另一个导管可以被放在第一片856与第二片858之间以将流体从接驳体866输送到可膨胀的囊808。如果使用这样的导管，那么导管在位于可膨胀的囊808内的那些区域处可以具有穿孔，使得导管可以被输送到穿孔。敷料806还可以与示例性实施方案中描述的其他部件结合使用，诸如图1中的覆盖物118。
虽然已经在某些示例性的、非限制性的实施方案的背景下公开了本发明及其优势，但是应当理解，可以做出各种变化、替换、置换和改动而并不偏离由所附权利要求界定的本发明的范围。
Claims (42)
1.一种用于向患者的组织部位提供减压治疗的系统，所述系统包括：
减压源，其用于供给减压；
流体源，其用于供给流体；
多个可膨胀的囊，其用于靠近所述组织部位放置，所述可膨胀的囊可操作来接收流体且从未膨胀位置膨胀到膨胀位置；以及
多个室，所述室是可压缩的；
其中，所述多个室中的至少一个被置于所述多个可膨胀的囊中的相邻的可膨胀的囊之间。
2.如权利要求1所述的系统，其中，当所述可膨胀的囊从所述未膨胀位置膨胀到所述膨胀位置时，所述室压缩。
3.如权利要求1所述的系统，还包括：
覆盖物，其用于当所述可膨胀的囊接近患者的表皮放置时覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室；并且
其中，所述室可操作来接收减压，所述减压造成所述室缩陷并使所述可膨胀的囊彼此更靠近地移动。
4.如权利要求1所述的系统，还包括：
覆盖物，其用于当所述可膨胀的囊接近患者的表皮放置时覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室；
减压导管，其用于输送减压；
减压接驳体，其用于连接到所述覆盖物且可操作来提供所述减压导管与所述密封空间之间的流体相通；并且
其中，所述室可操作来接收减压且受到减压作用而缩陷。
5.如权利要求1所述的系统，还包括：
覆盖物，其用于覆盖所述可膨胀的囊以形成接近所述组织部位的密封空间，所述密封空间包括所述室；以及
粘合剂，其用于将所述覆盖物的外周连接到患者以促进所述密封空间的密封；并且
其中，所述室可操作来接收减压且至少部分地受到减压作用而缩陷。
6.如权利要求1所述的系统，其中：
所述可膨胀的囊和所述室形成有顶壁、底壁和柔性的侧壁，且所述柔性的侧壁的至少一部分将所述可膨胀的囊与所述室分隔；并且
所述室可操作来接收减压，所述室可操作以在减压作用下缩陷并使所述可膨胀的囊彼此更靠近地移动。
7.如权利要求1所述的系统，其中：
所述可膨胀的囊和所述室形成有顶壁、底壁和柔性的侧壁，且所述柔性的侧壁的至少一部分将所述可膨胀的囊与所述室分隔；
所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动；并且
当所述可膨胀的囊处于所述未膨胀位置时，所述可膨胀的囊中的每一个具有大体矩形的横截面形状，且在不存在减压时，所述室的每一个具有大体矩形的横截面形状。
8.如权利要求1所述的系统，还包括：
第一片；以及
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管用于提供所述可膨胀的囊之间的流体相通。
9.如权利要求1所述的系统，还包括：
第一片；和
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；并且
其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
10.如权利要求1所述的系统，还包括：
第一片；
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；
双管腔导管，其流体地连接至所述减压源和所述流体源，所述双管腔导管具有用于输送减压的第一管腔和用于输送流体的第二管腔；
接驳体，其用于流体地连接至所述多个室和所述减压源以及流体地连接至所述流体源和所述多个可膨胀的囊，所述接驳体可操作来输送减压和流体；并且
其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
11.如权利要求1所述的系统，还包括：
第一片；以及
第二片，其被沿着焊接线焊接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
12.如权利要求1所述的系统，其中，所述可膨胀的囊中的至少一个可膨胀的囊包括：
支柱，其用于当所述至少一个可膨胀的囊被膨胀时，将所述至少一个可膨胀的囊限制成沿着一个方向膨胀。
13.如权利要求1所述的系统，还包括：
流体导管，其用于提供所述流体源与所述可膨胀的囊之间的流体相通；以及
流体接驳体，其将所述流体导管流体地连接至所述可膨胀的囊。
14.如权利要求1所述的系统，还包括：
分配导管，其用于提供所述可膨胀的囊之间的流体相通。
15.如权利要求1所述的系统，还包括：
分配导管，其用于提供所述可膨胀的囊之间的流体相通，其中，所述分配导管是波纹状的以促进所述可膨胀的囊的移动。
16.如权利要求1所述的系统，其中：
所述可膨胀的囊中的每一个在处于所述膨胀位置时是大体圆柱形的，并且
所述可膨胀的囊彼此是大体平行的。
17.如权利要求1所述的系统，其中，所述可膨胀的囊形成同心的环。
18.如权利要求1所述的系统，其中，所述室可操作来接收减压，所述减压造成所述室缩陷并使所述可膨胀的囊彼此更靠近地移动，使得闭合力施加到所述组织部位处的伤口。
19.一种用于向患者的组织部位提供减压治疗的装置，所述装置包括：
多个可膨胀的囊，其用于邻近所述组织部位放置，所述可膨胀的囊可操作来接收流体且从未膨胀位置膨胀到膨胀位置；以及
多个室，所述室是可压缩的；
其中，所述多个室中的至少一个被置于所述多个可膨胀的囊中的相邻的可膨胀的囊之间。
20.如权利要求19所述的装置，其中，当所述可膨胀的囊从所述未膨胀位置膨胀到所述膨胀位置时，所述室压缩。
21.如权利要求19所述的装置，还包括：
覆盖物，其用于覆盖所述可膨胀的囊以形成接近患者的多个密封空间，所述密封空间包括所述室；并且
其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
22.如权利要求19所述的装置，还包括：
覆盖物，其用于覆盖所述可膨胀的囊以形成接近患者的多个密封空间，所述密封空间包括所述室；
减压导管，其用于输送减压；
减压接驳体，其用于流体地连接所述减压导管与所述多个密封空间；并且
其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
23.如权利要求19所述的装置，还包括：
覆盖物，其用于覆盖所述可膨胀的囊以形成多个密封空间，所述密封空间包括所述室；
粘合剂，其用于将所述覆盖物的外周连接到患者以促进所述密封空间的密封；并且
其中，所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动。
24.如权利要求19所述的装置，其中：
所述可膨胀的囊和所述室形成有顶壁、底壁和柔性的侧壁；并且
所述室可操作来接收减压且缩陷，由此使所述可膨胀的囊彼此更靠近地移动。
25.如权利要求19所述的装置，其中：
所述可膨胀的囊和所述室由顶壁、底壁和柔性的侧壁形成；
所述室可操作来接收减压且缩陷并使所述可膨胀的囊彼此更靠近地移动；并且
当所述可膨胀的囊处于所述未膨胀位置时，所述可膨胀的囊中的每一个具有大体矩形的横截面形状，且在不存在减压时，所述室的每一个具有大体矩形的横截面形状。
26.如权利要求19所述的装置，还包括：
第一片；以及
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
27.如权利要求19所述的装置，还包括：
第一片；和
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；并且
其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
28.如权利要求19所述的装置，还包括：
第一片；
第二片，其连接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通；
减压源，其用于供给减压；
流体源，其用于供给流体；
双管腔导管，其流体地连接至所述减压源和所述流体源，所述双管腔导管具有用于输送减压的第一管腔和用于输送流体的第二管腔；
接驳体，其用于流体地连接至所述多个室和所述减压源以及流体地连接至所述流体源和所述多个可膨胀的囊，所述接驳体可操作来输送减压和流体；并且
其中，所述室可操作来接收减压且受到减压作用而缩陷并使所述可膨胀的囊彼此更靠近地移动。
29.如权利要求19所述的装置，还包括：
第一片；以及
第二片，其被沿着焊接线焊接到所述第一片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
30.如权利要求19所述的装置，其中，所述可膨胀的囊中的至少一个可膨胀的囊包括：
支柱，其用于当所述至少一个可膨胀的囊被膨胀时，将所述至少一个可膨胀的囊限制成沿着一个方向膨胀。
31.如权利要求19所述的装置，还包括：
流体源，其用于供给流体；
流体导管，其用于提供所述流体源与所述可膨胀的囊之间的流体相通；以及
流体接驳体，其将所述流体导管流体地连接至所述可膨胀的囊。
32.如权利要求19所述的装置，还包括：
分配导管，其用于提供所述可膨胀的囊之间的流体相通。
33.如权利要求19所述的装置，还包括：
分配导管，其用于提供所述可膨胀的囊之间的流体相通，其中，所述分配导管是波纹状的以促进所述可膨胀的囊的移动。
34.如权利要求19所述的装置，其中：
所述可膨胀的囊中的每一个在处于所述膨胀位置时是大体圆柱形的，并且
所述可膨胀的囊彼此是大体平行的。
35.如权利要求19所述的装置，其中，所述可膨胀的囊形成同心的环。
36.如权利要求19所述的装置，其中，所述室可操作来接收减压，所述减压造成所述室缩陷并使所述可膨胀的囊彼此更靠近地移动，使得闭合力施加到所述组织部位处的伤口。
37.一种制造用于向患者的组织部位提供减压治疗的装置的方法，所述方法包括：
形成多个可膨胀的囊；形成连接至所述可膨胀的囊的多个室；其中，所述可膨胀的囊可操作来接收流体并从未膨胀位置膨胀到膨胀位置，所述可膨胀的囊还适合于邻近所述组织部位放置；以及
连接所述多个可膨胀的囊与所述多个室。
38.如权利要求37所述的方法，还包括：
提供分配导管；以及
使用所述分配导管将所述可膨胀的囊彼此流体地连接。
39.如权利要求37所述的方法，还包括：
提供分配导管；
使用所述分配导管将所述可膨胀的囊彼此流体地连接；以及
提供覆盖物，所述覆盖物适合于覆盖所述可膨胀的囊以形成密封空间，所述密封空间包括所述室。
40.如权利要求37所述的方法，其中，形成所述可膨胀的囊的步骤包括：
提供第一片；
提供第二片；以及
将所述第一片连接到所述第二片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
41.如权利要求37所述的方法，其中，形成所述可膨胀的囊的步骤包括：
提供第一片；
提供第二片；以及
将所述第一片沿着焊接线焊接到所述第二片以形成所述可膨胀的囊、所述室和分配导管，所述分配导管提供所述可膨胀的囊之间的流体相通。
42.如权利要求37所述的方法，其中，形成所述可膨胀的囊的步骤包括：
形成顶壁、底壁和将所述顶壁连接到所述底壁的柔性的侧壁。
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| PCT/US2009/045753 WO2009158131A1 (en) | 2008-05-30 | 2009-05-29 | Wound dressing with inflatable bladders |
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