CN103619366B - 外科腔引流和闭合系统 - Google Patents
外科腔引流和闭合系统 Download PDFInfo
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Abstract
一种外科引流设备,包括生物可降解聚合物材料的粘结基质和连接至该基质的多根引流管。例如,将该设备植入外科伤口内,以治疗血清肿的存在,并用于促进引流、组织粘合和伤口闭合。引流管会合至共同的收集管中,在重力供给或施加于收集管的负压下,收集管引导伤口流体流出体外。该基质含有孔的阵列,允许组织穿过设备接触。该设备还可以包括外科粘合剂的涂层和钩或倒刺的组织锚定系统。该设备和包含该设备的系统特别用于促进腹部外科手术产生的外科伤口的愈合。
Description
相关申请的交叉参考
本申请要求2011年4月15日提交的美国申请No.61/475,945的优先权。将以上申请的全部内容通过引用的方式并入本文中。
发明背景
已经提出各种系统用于引流外科伤口。然而,这些系统的功效是有限的,尤其是对于较大的外科空间或其中存在特定特征(如,运动或形状)或特定生理特征(如,淋巴引流或低蛋白)的那些。血清肿是外科手术后常见的并发症,会在很多血管被切断时发生,其使血浆从血液和淋巴循环中渗漏出来。可以导致血清肿形成的外科伤口包括由涉及腹部皮瓣的外科手术(诸如腹壁成形外科手术)、乳房重建外科手术、脂膜切除术(panniculectomy)和腹疝修复形成的伤口。
可用的外科引流设备具有几个缺点,特别是腹部皮瓣外科手术后使用时。它们不能充分地引流流体,易阻塞,并且不能促进伤口内的组织粘合。因此,对研发用于外科伤口的改进治疗仍然存在需求。这种需求在腹部外科手术中特别迫切,如用于防止和治疗血清肿,也可以用于易于产生过量流体引流或组织运动状况的任何外科伤口,或得益于组织粘合需求,如由组织采集程序引起的压力性溃疡或伤口。
发明概述
本发明提供了用于防止和治疗血清肿以及在促进外科伤口引流和伤口闭合中通用的外科引流设备。该引流设备包括安置在称为“粘结基质(adhesion matrix)”的基底上的多个引流管,所述粘结基质设计来促进血清肿或伤口空间内的组织粘合。所述粘结基质具有顺应构造,并且由具有平面的顺应性材料制得,所述平面可以弯曲,以适合伤口空间的形状。
在优选的实施方式中,粘结基质在基质材料中含有多个孔或缝隙,其允许组织穿过基质接触,使得促进粘合和伤口闭合。因此,在基质第一侧上的组织表面可以直接接触基质第二侧或相对侧上的组织表面,以促进伤口的快速愈合和稳定。可以基于伤口的几何形状来选择延伸穿过基质的孔的数量、尺寸和分布。例如,对于腹部伤口,引流管可以以扇形阵列安置,其中多个三管或多管从总管延伸出来。可以由使用者将基质和/或管切割或成型,以顺应伤口的形状。基质也可以用作药物载体,来帮助将药物给药于患者。基质可以任选在其任一表面的至少一部分上包括粘合剂层。一旦引流实质性地减少,可以将引流管从设备中移除,而粘结基质可以留在体内,它在体内随着时间被降解和吸收,在适当的位置保持以优化组织愈合。基质可以包含多孔性生物可降解的聚合物材料。随着多个管从单个出口部位延伸至伤口中且远端间隔开,使用者可以容易地从伤口中同时移除所有管子。
外科引流设备可以包括组织锚定系统,由此通过表面倒刺或钩的阵列将设备机械连接至周围组织。这些表面结构可以位于粘结基质的任何暴露表面上。当设备被植入时,可以相对倒刺或钩按压周围组织,以将它们包埋在组织内并且固定设备。表面倒刺或钩的使用可以结合外科粘合剂来使用,以提供比单独使用粘合剂强得多的组织层之间的结合,并且在粘合剂固定的同时提供临时的粘合。根据打算结合的组织,钩的结构可以具有各种形式。较长的钩可以用于松散结合的组织,如脂肪或结缔组织,而较短的钩可以用于较致密的组织,如肌肉。具有较大刚性杆部的锚可以用于穿透较致密组织。
本发明的另一个方面是用于外科伤口引流的系统。该系统包括上述的引流设备和真空源(如泵)、以及连接真空源至引流设备的引流管的管。该系统还可以任选包括用于收集引流流体的流体收集器以及用于监控和控制施加真空和收集流体的控制单元。系统的更多部件可以包括真空或压力计、流量计以及用于监控真空和流动并调节真空或流动的计算机。
本发明的另一个方面是用于治疗或防止血清肿的方法,或促进外科伤口引流或闭合的方法。该方法包括将上述的引流设备放入血清肿或外科伤口中,如有形成血清肿风险的伤口,并使设备从伤口引流流体一段时间。设备可以包括外科粘合剂和/或位于其表面上的倒刺或钩,以在伤口内的组织层之间形成粘合,并将设备固定就位。引流可以通过重力流,或可以通过将真空源连接至设备的引流管而得到真空的辅助,使用总管以将引流管的流动路径并入至用于收集的共用引流管中。施加于引流管的负压可以用于将设备上下的组织层保持在一起,直至外科粘合剂固定,或直至伤口愈合过程将组织结合在一起。负压的施加通过基质中的孔进一步促进基质相对侧的组织之间的接触,来促进组织粘合。这提高了愈合速率,同时提供了引流。任选地,引流减少后,将设备的引流管从身体中移除,由此降低身体再吸收的负担。可以通过在粘结基质内包含引流管通道或引流管释放片来促进引流管的移除。然后通过将管滑出通道或适当地操纵引流管组件来破坏释放片,从而完成引流管的释放。允许粘结基质保留在血清肿或外科伤口中,它在那随着时间被再吸收。
可以通过流动控制元件来调节来自引流管的流速。也可以通过超声波设备或通过其他方法来测量流速或测量流体压强。所述系统还可以结合伤口敷料来使用,所述伤口敷料也可以连接至负压源,以从伤口移除流体。
附图说明
图1显示了具有由腹部外科手术产生的腹部皮瓣伤口的患者的腹部的视图。
图2显示了已经通过腹部皮瓣伤口插入的根据本发明的外科引流设备的视图。
图3显示了在人类患者腹部中在皮下组织和腹膜肌肉层之间安装的根据本发明的外科引流设备的横截面视图。
图4是根据本发明的外科伤口引流系统的示意图。
图5A-5G是根据本发明的外科引流设备的实施方式的图示,其描绘了设备内的引流管的配置以及引流管和聚合物基质的特征。图5A-5D显示了将引流管连接至聚合物基质的具有不同机理的代表性实施方式。在图5A中,将引流管包埋在引流管通道内,而在图5B中,通过保持结构来连接引流管。在图5C中,将引流管粘贴在基质上,而在图5D中,将引流管点焊在基质上。图5E和5F显示了引流管通道内不同构造的引流管的实施方式。图5G显示了具有用于收集流体的横向孔的引流管实施方式。
图6A-6C显示了具有不同类型的组织接触孔的粘结基质的实施方式的图示。图6D是在其表面上具有组织锚的粘结基质实施方式的图示。图6E显示了图6D的粘结基质的横截面视图。
图7A-7C是放置在伤口或血清肿内的引流设备的不同实施方式的横截面图示。这些实施方式包括一层或多层粘合剂。
图8示出了根据本发明的优选实施方式进行伤口闭合治疗的处理顺序。
图9示出了其中伤口敷料没有覆盖在引流出口部位上的伤口引流和伤口敷料系统。
图9B示出了其中伤口敷料覆盖在引流出口部位上的伤口引流和伤口敷料系统。
图10A和10B示出了可以用于本发明的优选实施方式中的引流出口管组件的横截面视图。
图11是根据本发明优选实施方式的组织锚定网片的侧视图。
图12是处理流程图,其示出了根据本发明优选实施方式的伤口敷料和引流系统的使用方法。
发明详述
本发明提供了一种使流体从外科伤口引流出来并促进伤口愈合的外科引流设备、系统和方法。例如,优选的实施方式用于防止或治疗血清肿。引流设备的特征在于连接基底的一组引流管,所述基底在本文中称为粘结基质,其设计成促进伤口或血清肿内的组织粘合并且促进细胞渗透至设备自身中。引流管穿过粘结基质分布,以促进穿过设备的均匀引流。为了促进最佳引流,引流管可以穿过粘结基质均匀地分布。引流设备可以留在伤口内就位并持续一段时间,例如,直至流体渗流减少,此后,可以从设备撤去所述引流管并从患者移除设备,而没有干扰粘结基质,粘结基质保留就位进行生物降解或结合至愈合过程中。该设备有效地促进了甚至大面积伤口的愈合,如由腹部皮瓣外科手术产生的那些伤口。
将根据本发明的外科引流设备通过患者皮肤中的切口插入并且放置在外科手术过程中形成的伤口内。第一个目的是在外科手术过程中引出流体。在外科手术后,该系统可以保留就位,并且提供持续数天或甚至数周的引流。该设备可以用于血清肿的治疗,例如,引出血清肿并且由此促进其愈合,其还可以用于防止血清肿形成。例如,可以在外科手术后立即常规地将引流设备放入外科切口区域中并且用于该区域的引流和帮助防止血清肿形成。或者,可以通过打开血清肿并安装该设备,从而将该设备放入已经形成的血清肿中。即使只降低了血清肿形成的可能性,所述引流设备的使用也理解为“防止”血清肿形成。相似地,即使只提高了血清肿愈合的可能性,所述引流设备的使用也理解为“治疗”血清肿形成。图1显示了患者的由腹部外科手术产生的腹壁成形术或腹部皮瓣伤口10。图2显示了通过腹部皮瓣伤口10插入并且插入至由血清肿15占据的空间中的外科引流设备20。
根据本发明的设备包括在其近端连接至总管40的多个可移除的引流管30,总管40通过真空管50连接至真空源。引流设备通过引流管收集和移除来自腹部区域或来自血清肿流体空间的流体,引流管通过真空源的帮助将流体转移至患者体外。根据设备的需要,包括待引流的流体量以及伤口的尺寸和设备的形状,引流管的数量可以不同。通常,设备含有2至约20根引流管。在优选的实施方式中,设备含有优选至少3根管,并且对于较大的区域,如腹部,含有例如约5至约12根管。
引流管可以从任何生物相容的热塑性或热固性材料制得。实例包括外科手术级别的硅橡胶、聚氨酯、聚酰胺、聚酰亚胺、PEEK(聚醚醚酮)、聚碳酸酯、PMMA(聚甲基丙烯酸甲酯)和聚氯乙烯。在流体累积已经降至稳定而不需要引流的水平后,打算移除引流管。然而,在可替换的实施方式中,引流管可以由生物可降解材料制得并且可以保留就位。引流管可以是柔性的,使得顺应于围绕该设备的组织和适应患者的移动而不会引起不适。引流管可以是开放端部的或闭合端部的。在优选的实施方式中,引流管是闭合端部的,并且沿着其长度具有孔或洞,用于吸收流体。
图3显示了安装在腹部中位于皮下组织70和腹部肌肉层80以及相关筋膜90之间的引流设备20。尽管在腹部皮瓣外科手术后可以使用这个位置,但设备的其他解剖位置也是可能的,并且考虑为本发明的合适用途。
图4示意地描绘了用于通过腹部皮瓣伤口引流血清肿的系统。系统21包括引流设备20,其具有连接至粘结基质25的多根引流管30,并且构造成可以引流全部程度的血清肿。引流管在其近端连接至总管40,总管40又通过真空管50连接至真空泵130或其他真空源。从伤口引流出来的流体125可以任选累积在流体收集器120中。真空泵或其他真空源130可以包括一个或多个电子设备,如具有存储器和软件的微处理器,以监控真空水平、气阻和/或流体移除量或速率。电子设备还可以根据使用者限定的参数、根据预先设定的程序或响应于在真空、阻力和/或流体移除方面收集的数据来控制系统随着时间的运行。
图5A-5G描绘了根据本发明的引流设备的代表性实施方式,显示了设备内的引流管的几种可能的构造。图5A显示了其中将每根引流管30放置在分开的引流管通道35内的实施方式。引流管通道包埋在粘结基质25内或连接至粘结基质25的表面,并且决定设备内的引流管的方向和分布。在优选的实施方式中,引流管通道以及因此引流管均匀地分布在引流设备的表面区域中,如图4中所示。这些可以大致放射状分布、从基质上的一边或一个区域延伸,使得能够从伤口使用单个出口管。然而,如果期望,引流管可以不均匀地分布,例如,以提高设备特定区域的引流能力或速率。引流管通道的使用确保引流管在患者体内保持就位,并且确保在合适的时间可以容易地移除引流管,而不会妨碍伤口愈合过程。引流管通道需要接收流体并将其传递至引流管内的机械装置。合适的机械装置包括使用沿着通道的长度的任何所期望形状和分布的孔或洞(参见,例如,图6D中的通道35上的孔33),和使用多孔材料来形成引流管通道(参见图5E和5F中的引流管通道35,其由多孔聚合物基质构成)。
还考虑了几个可替换的实施方式,其没有引流管通道。图5B描绘了使用保持结构35a替代通道,以将引流管可移除地连接至粘结基质,同时允许通过滑动或通过断开保持结构来移除管。保持结构可以具有与其功能相适应的任何形式。图5C显示了其中引流管20通过粘合剂层31保持就位的实施方式,并且管装配在粘结基质25表面上的凹坑内。在图5D所示的相关实施方式中,引流管通过点焊或粘合点32保持在基质凹坑中,点焊或粘合点可以通过合适的操作来破坏,以移除管。
图5E和5F呈现了根据本发明的引流设备的实施方式的粘结基质25的一部分的横截面视图。粘结基质含有用于接收引流管的区域,或可以包括一个或多个引流管通道35,其围绕引流管30,具有管腔34,通过管腔34移除血清肿或其他伤口流体。圆形Blake引流描绘为图5E中的引流管,并且其扁平型式描绘于图5F中。各种不同的引流管轮廓形状是可能的,包括卵形、椭圆形、正方形、矩形、三角形、扁平的、复合的(即,具有2个或多个平行管腔,其为互通的或分开的),或不规则的。引流管任选可以在其外表面上涂覆润滑剂,以促进它们从通道中移除。
在优选的实施方式中,引流管沿着其长度具有开口或孔33,以允许流体进入,从而引流。图5G描绘了一个这样的实施方式。可以选择这些孔的相对表面积和分布,以调节通过引流管的流动。例如,可以通过增加朝向引流管远端的开口表面积或孔的密度来补偿沿着引流管长度的压降(即,真空的损耗)。具有沿着引流管长度提供基本上恒定的流体吸收速率的孔分布(例如,朝向远端的增加的孔面积)的引流管是优选的,其使得在引流设备中获得均匀的引流。
粘结基质25包括多个孔27或矩阵式的孔27,其允许通过引流设备的组织接触。这样的组织接触促进伤口愈合和毛细管的封闭,这对于治疗血清肿或防止血清肿形成是重要的。在根据本发明的引流设备中,组织接触的促进结合流体引流一起工作,以促进伤口愈合。粘结基质25及其引流管通道35优选由一种或多种生物可降解聚合物材料构成,并且可以留在伤口内,它们在那稳定组织渗透和粘合,并且因此促进愈合过程。组织接触孔27的尺寸、形状和分布可以根据个体需要而不同。然而,穿过设备的组织接触越多,就将促进更好的粘合、引流和伤口闭合。因此,优选引流设备的至少约50%、60%或70%,并且更好的是约75-80%的总表面积(一侧)以组织接触孔的形式保持开放。组织接触孔的分布和间隔可以按照所期望的而不同,并且设备中的孔的形状、尺寸和分布可以相同、相似或不同。例如,孔可以以约2mm至约20mm或更大范围的平均中心-中心间隔分布,并且平均的单个孔的表面积可以在约1mm2至约5cm2的范围内。在优选的实施方式中,孔具有约1cm2的平均表面积,并且它们的数量或它们的总表面积从引流设备的近端(即,接近身体的出口点)朝向设备的远端(伤口或血清肿内的深处)逐渐变大,使得组织粘合和伤口闭合从伤口内的深处进展至身体的表面。
图6A-6E显示了粘结基质的几个实施方式。显示了粘结基质25的在两根相邻引流管30和引流通道35之间的一部分。图6A中所示的实施方式具有矩形孔27的规则排列,以允许通过设备的组织接触。图6B中显示了圆形孔。图6C的实施方式包括形成于横向通道中的孔27。流体通过这些通道横向地流向引流管通道中的开口36,通过引流管中降低的压力抽取。如图6D和6E中所示,粘结基质的表面,包括引流通道,可以具有钩或倒刺的布置,以促进设备锚定在邻近组织中。在图6E中所示的实施方式中,上侧28上的钩长于下侧29上的钩。在设备任一侧的组织密度不同的情况中,可以使用这种布置。例如,较长的钩(如约1.5至约3mm长)优选用于不太致密的组织,如皮下脂肪组织,而较短的钩(如约0.5至约1.5mm长)优选用于较致密组织,如筋膜和肌肉。
粘结基质,包括任意的引流管通道和钩或倒刺,可以从生物可降解的聚合物材料制得,因为在移除引流管后,打算将这些结构在患者身体内保留就位,使得不会妨碍愈合过程。合适的生物可降解或可再吸收材料的实例包括Vicryl(聚乙醇酸)、Monocryl(乙醇酸-ε-己内酯共聚物)、PDS(聚对二氧环己酮,PDO)、PLA(聚乳酸,聚交酯)、PLLA(聚-L-乳酸)、PDLA(聚-D-乳酸)、PGA(聚乙醇酸,聚乙交酯)、PLGA(聚(乳酸-共-乙醇酸))、PHB(聚羟基丁酸酯)和PCL(聚己酸内酯)。在优选的实施方式中,粘结基质,包括任意的引流管通道,由开放的聚合物链网络形成,所述聚合物链的多孔性足以允许细胞渗透和流体流过材料。细胞渗透可以促进组织粘合,以及伤口愈合后的聚合物的生物降解。在一些实施方式中,包括任意的引流管通道的粘结基质可以透过血清肿流体,但细胞不能透过。在其他实施方式中,对于包括任意的引流管通道的粘结基质,流体和电解质可以透过,但蛋白质不能透过。构成基质基础基底的基质聚合物材料的渗透特性与构成引流管通道的材料相比,可以相同或不同。在优选的实施方式中,粘结基质的聚合物链、或聚合物链组成的纤维,沿着基本上垂直于最近的引流管的轴线的轴线排列。这种排列模式促进了流体通过或沿着粘结基质表面流向引流管。
粘结基质,并且由此整个引流设备,可以具有适于插入其待插入的伤口或血清肿中的任何形式。通常,该形式是具有基本上矩形形状的薄片。然而,形状可以是圆形、环状、椭圆形、卵形或不规则的。优选拐角是圆形的,使得对周围组织的机械刺激最小化。设备的尺寸也通过特定的用途和患者的解剖来决定。例如,粘结基质可以具有约2cm至25cm范围的整体宽度和长度,如约10cm×12cm或约20cm×25cm。粘结基质的厚度可以为约0.5mm至约1cm;其中材料片的厚度优选小于5mm,并且优选粘结基质为约1-2mm厚。整个引流设备的厚度,包括粘结基质层、引流管和任意的钩或胶垫,为约5mm或更小,10mm或更小,或约5-10mm。
除了使用稳定引流装置任一侧上的组织层的钩或倒刺结构以外,或替代使用稳定引流装置任一侧上的组织层的钩或倒刺结构,粘结基质可以涂覆粘合剂材料,如外科胶。可以使用适用于身体内的任何类型的外科粘合剂,包括聚乙二醇聚合物、粘合蛋白质、明胶-凝血酶混合物、白蛋白-戊二醛和基于纤维蛋白的密封剂。避免氰基丙烯酸酯,因为如果内部使用会引起炎症。可以将粘合剂涂层放置在粘合基质的一个或两个表面上。将设备放入患者体内之前,将粘合剂涂层施用于设备,即,作为设备制造过程的一部分。粘合剂涂层可以覆盖全部或一部分的设备表面。可以以浸有粘合剂组合物的纤维毯片或垫子的形式来使用外科粘合剂。毯片或垫子优选由生物可降解聚合物制得,如用于制备粘结基质的类型。可以在放入患者体内时,在设备和周围组织之间放置一层或多层粘合剂材料。图7A-7C图示了附加粘合剂层与引流设备的放置。在图7A中,粘合剂层或垫子140已经放入邻近暴露组织150的伤口或血清肿中。在图7B中,引流设备20已经放在如图7A中所示的粘合剂层上,然后将伤口闭合并施加真空,使得设备-粘合剂垫夹层被组织150包围。图7C描绘了如果将第二个粘合剂垫或层140加入到邻近引流设备的第一个粘合剂层的对侧时所获得的结构。
本发明还提供了用于治疗或防止血清肿的方法,如图8中所示。该方法还可以用于促进外科手术后的伤口闭合(步骤210),以防止外科手术后的感染,和提高外科伤口完全愈合后的强度和/或美学外观。将根据本发明的引流设备放入外科伤口中(步骤220),如腹部皮瓣外科手术后的伤口。在放入伤口内之前,设备已经灭菌。任选地,将一层或多层外科粘合剂放在设备的一侧或两侧,形成设备和周围组织230之间的界面。如果设备在一侧或两侧包括钩或倒刺,给设备的表面施加压力,以将钩或倒刺固定至周围组织中。然后将伤口在表面部分地通过外科手术闭合,留下单根管伸出伤口。然后将管连接至真空源(步骤240),并且施加真空(步骤250),使得启动通过设备的引流。通过所用的真空水平来控制引流速率。真空度足以促进引流,而不会引起植入的设备周围组织的损伤。例如,真空可以在约75至250mmHg的范围中。在流体引流速率已经降至可接受的水平后,移除真空,并且通过剩余的伤口开口缓慢拉出引流管来移除引流管(步骤260),随后将伤口开口闭合。粘结基质保留在患者体内,并且在数周至数月的时间段内被生物降解和吸收。
结合图9A和9B图示的是结合粘结基质或网片设备和负压引流系统的伤口敷料的使用。如本文中详细描述的,放置基质404后,引流管405通过患者皮肤401的出口部位409伸出。伤口常常需要使用伤口敷料402,其从外部放置在患者皮肤上。伤口敷料可以覆盖出口部位456,如图9B中所示,或伤口敷料可以放在出口部位409的旁边(或非覆盖的),如图9A中所示。管405可以直接连接泵420,或可以利用放置在皮肤401上面或高处的连接器或总管412,连接器或总管412可以连接泵420。阀408可以用于控制负压的施加。在连接器或总管412处或在阀408处可以包括流量计,以测量流体移除速率和移除的流体总量。由此可以测量和记录所移除的流体的定量测量结果。其他诊断测量设备,如超声设备,也可以用来测量伤口内的流体或血清肿的量和位置。这种信息可以用于调节使用引流系统404、454和伤口敷料402、452的伤口内施加的负压的量和分布。
负压可以通过单独的管415施加于伤口敷料402,管415可以连接至与引流系统相同的泵420或连接至第二个泵。阀406可以用于调节伤口敷料的压力。在图9B的实施方式中,一根或多根管458可以伸出伤口并且在连接器462处连接至敷料452的下侧。总管470可以使用被动或主动流动控制元件来控制敷料452和引流设备454两者的负压分布。可以使用单根管460将总管连接至泵480。泵420、480可以通过手动或电子方式来运行。泵可以具有内部电子控制器、存储器和展示元件485,以控制系统运行和记录患者数据。
图10A和10B中显示的是可以结合本发明使用的引流管组件的优选实施方式。引流管405、458优选作为单管或作为外管内的管簇伸出伤口。外管504可以是多个排成一行的三根或多根管502的扁平形500,如图10A中所示;或可以是圆形520,其中引流管522在外管522内伸出至泵或连接器。在特定的应用中,在不同的时间点从引流系统中分开移除管是有利的,因为特定的区域可能引流更快。然而,对于许多伤口,同时从伤口移除所有引流管是有用的。
图11中显示的是用于本发明优选实施方式中的粘结基质或网片540的侧视图。使用这样的网片来促进伤口粘合和愈合常常是有用的,其使用可以粘附在伤口内的组织的两侧的可吸收材料。这些组织常常在网片的相对侧是不同类型的。因此,网片可以包括在两侧具有组织锚544、546的顺应(conformable)层542。然而,因为一侧可以用于连接至皮肤皮瓣下侧上的脂肪组织(fatty或adipose),第一组多个组织锚544具有适用于连接至脂肪组织的形状和刚性。第二组多个组织锚的形状和尺寸适于连接不太柔顺的组织,如筋膜或肌肉。需要更大刚性的钩或倒刺来实现这种连接。
图12中显示的是施用根据本发明的引流和伤口敷料系统的方法600的步骤顺序。对患者进行程序610后,将伤口闭合设备插入患者的伤口中(步骤620)。这可以是元件的组合,如特定伤口区域中的图11中所示的网片,以及在需要引流流体的伤口区域中的本文概述的引流和网片系统。这还可以包括使用粘合剂和/或组织锚,使得组织通过网片更直接的接触,并且由此提高愈合速率(步骤630)。如本文中所述的,还可以将伤口敷料施用于伤口(步骤640)。然后可以将泵连接至引流系统和/或伤口敷料(步骤650),并且将负压施加于一个或两个元件,以引流流体和促进组织通过植入的网片或基质接触(步骤660)。可以测量和记录流体通过每根管的流速,并且可以通过超声波或其他系统监控流体的存在(步骤670)。当引流速率降低时,可以移除引流管(步骤680)。按照需要,可以替换伤口敷料(步骤690),并且可以继续用于引流伤口(步骤690)。
尽管已经参考优选的实施方式特别地显示和描述了本发明,但本领域技术人员将理解可以形成其中的形式和/或细节的各种变化及其等价物,而没有脱离所附权利要求列出的本发明的精神和范围。
Claims (38)
1.一种负压外科引流设备,其包括与粘结基质的管接收区域接触放置的多根引流管,所述粘结基质具有伤口顺应形状并且包括具有多个用于在植入所述伤口中时通过所述粘结基质进行组织接触的分隔的孔的生物可降解聚合物材料层,以使得所述粘结基质的第一侧上的第一组织表面可以通过所述多个分隔的孔接触所述粘结基质的第二侧上的第二组织表面,所述引流管跨越所述分隔的孔之间所述材料层的管接收表面区域延伸并能够与负压源连接和能够在向所述伤口施加负压后从与所述粘结基质的接触中移除,所述负压使得所述粘结基质粘附于所述组织。
2.权利要求1所述的设备,其中所述粘结基质进一步包括粘合剂。
3.权利要求1所述的设备,其中所述粘结基质进一步包括组织锚。
4.权利要求1所述的设备,其中所述多根引流管包括至少三根连接至总管的管。
5.权利要求1所述的设备,其中所述粘结基质包括具有小于2mm厚度的片。
6.一种用于外科伤口引流的系统,所述系统包括权利要求1的引流设备、真空源以及将真空源连接至所述引流设备的引流管的管。
7.权利要求1所述的设备,其中所述粘结基质包括聚合物网片,所述聚合物网片在第一侧表面上具有第一组多个组织锚,并且在第二侧表面上具有第二组多个组织锚。
8.权利要求1所述的设备,其中每根引流管在近侧部分从伤口进入部位延伸至可放置在伤口内的远端。
9.权利要求6所述的系统,其中所述设备进一步包括伤口敷料。
10.权利要求9所述的系统,其中所述伤口敷料与真空源联接。
11.权利要求9所述的系统,其中所述伤口敷料覆盖引流管出口部位。
12.权利要求6所述的系统,其进一步包括调节来自引流管的流动的流动调节系统。
13.权利要求1所述的设备,其中所述孔具有不同的尺寸。
14.权利要求1所述的设备,其中所述孔总共占据基质总面积的至少50%。
15.权利要求7所述的设备,其中所述第一组多个组织锚比所述第二组多个组织锚更具刚性。
16.权利要求4所述的设备,其中所述总管能够连接至负压源。
17.权利要求1所述的设备,其中所述引流管在所述粘结基质上以间隔的阵列形式放置,所述引流管从所述粘结基质边缘沿着不同放射方向发散。
18.权利要求1所述的设备,其中将所述引流管放置在所述粘结基质的引流通道中。
19.权利要求1所述的设备,其中所述孔被定位在所述粘结基质的第一侧上间隔开的引流管之间以促进至引流管的流动;所述粘结基质包括厚度为约0.5mm至约1cm的顺应层。
20.一种负压外科引流设备,其包括基质,所述基质具有伤口顺应形状并且包括具有多个用于通过基质进行组织接触的开放孔的生物可降解聚合物材料层,以使得所述基质的第一侧上的第一组织表面可以通过被所述材料层的表面区域分隔的所述多个开放孔接触所述基质的第二侧上的第二组织表面,所述基质包括生物可降解聚合物并且具有用于接收多根能够与负压源连接的引流管的管接收区域,所述负压源在所述孔内所述材料层的整个深度上对所述组织施加力,所述管接收区域跨越所述基质延伸且其中所述多个开放孔中的一个或多个位于邻近所述管接收区域的表面区域之间。
21.权利要求20所述的设备,其中所述基质进一步包括粘合剂。
22.权利要求20所述的设备,其中所述基质进一步包括组织锚。
23.权利要求20所述的设备,其中所述多根引流管包括至少三根连接至总管的管。
24.权利要求20所述的设备,其中所述基质包括具有小于2mm厚度的片。
25.权利要求20所述的设备,其中所述多个孔的每个孔具有1mm2至5cm2的面积。
26.权利要求20所述的设备,其中所述孔的总面积为至少50%的所述基质的表面积。
27.权利要求20所述的设备,其进一步包括在所述基质的第一侧上的第一组多个组织锚和在所述基质的第二侧上的第二组多个组织锚,所述第一组多个组织锚适用于连接至脂肪组织,而第二组多个组织锚适用于连接至筋膜和/或肌肉组织。
28.一种负压锚定基质,其包括生物可降解网片,所述网片包括第一网片表面区域,在所述第一网片表面区域上具有第一组多个组织锚,该网片进一步包括第二网片表面区域,在所述第二网片表面区域上具有第二组多个组织锚,所述第一组多个组织锚适用于连接至柔顺的第一组织表面,而具有与所述第一组多个组织锚不同的分布、大小和/或形状的所述第二组多个组织锚适用于连接至不太柔顺的第二组织表面,所述网片包括具有多个开放孔的生物可降解聚合物材料层,以使得所述网片的第一侧上的第一组织表面可以通过所述多个开放孔接触所述网片的第二侧上的第二组织表面,其中所述网片具有至少一个流体流通道,使得流体可以在施加负压时从伤口移除。
29.权利要求28所述的锚定基质,其中所述第一组多个组织锚的刚性比第二组多个组织锚的低。
30.权利要求28所述的锚定基质,其中所述第一组多个锚连接至脂肪组织。
31.权利要求28所述的锚定基质,其中所述第二组多个组织锚连接至筋膜和/或肌肉组织。
32.权利要求28所述的锚定基质,其中所述第二组多个组织锚包括倒刺。
33.权利要求28所述的锚定基质,其中所述基质包括可再吸收的聚合物网片。
34.权利要求28所述的锚定基质,其中所述多个孔分隔在一个或多个所述组织锚之间。
35.权利要求28所述的锚定基质,其中所述基质是多孔的,使得流体能够沿着基质表面流动。
36.权利要求28所述的锚定基质,其进一步包括粘合剂,以将所述基质的一侧连接至组织。
37.权利要求28所述的锚定基质,其中组织锚包括钩。
38.权利要求28所述的锚定基质,其中所述基质在置于所述第一组织表面和所述第二组织表面之间的伤口中时包括具有小于2mm厚度的顺应层。
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US20140039468A1 (en) | 2014-02-06 |
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CA2833232C (en) | 2018-05-22 |
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WO2012142473A1 (en) | 2012-10-18 |
MX364446B (es) | 2019-04-26 |
CA2833232A1 (en) | 2012-10-18 |
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