CN114901224A - 负压伤口敷料 - Google Patents
负压伤口敷料 Download PDFInfo
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- CN114901224A CN114901224A CN202080090293.0A CN202080090293A CN114901224A CN 114901224 A CN114901224 A CN 114901224A CN 202080090293 A CN202080090293 A CN 202080090293A CN 114901224 A CN114901224 A CN 114901224A
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Abstract
一种用于负压伤口治疗的敷料,包括:吸收层,所述吸收层包括用于吸收渗液的胶凝吸收材料;周边粘性皮肤接触层,所述周边粘性皮肤接触层包括水胶体粘合剂并限定一窗口,所述吸收层能够通过所述窗口接触伤口;以及不透水但能透气的覆盖层。所述覆盖层限定了一孔洞以便与泵组件一起使用以向伤口部位提供负压。
Description
技术领域
本文公开的主题总体上涉及负压敷料和具有负压敷料的负压组织治疗装置,更具体地涉及可与负压源一起使用以施行负压疗法的敷料。此类敷料适用于治疗包括慢性和急性类型的各种伤口,包括感染伤口、静脉溃疡、糖尿病溃疡、烧伤、手术伤口等。
背景技术
临床研究和实践表明,在组织部位附近提供负压会增强和加速组织部位处新组织的生长。此现象的应用很多,但负压的一种特殊应用涉及治疗伤口。这种治疗(在医学界常被称为“负压伤口疗法”、“减压疗法”或“真空疗法”)提供了许多好处,包括从伤口中抽出流体、上皮和皮下组织的迁移、改善的血流和伤口部位处组织的微变形。这些好处引起肉芽组织的发育增加和更快的愈合时间,同时还有助于减少疤痕形成的水平。典型地,负压由减压源通过多孔垫或其它歧管装置施加至组织,该多孔垫或其它歧管装置密封在患者伤口周围的皮肤或规定进行这种治疗的其它组织上。多孔垫包括能够将减压分布到组织并引导从组织抽取的流体的蜂窝或孔隙。多孔垫通常被结合到具有促进治疗的其它成分的敷料中。
在施用负压伤口疗法时,可以连续或间歇地施加负压,这取决于伤口或其它被治疗组织的类型和临床目标。敷料可以定期更换,比方说,例如每周一次、两次或三次(或根据需要)。术语“减压”和“负压”是指低于通常大气压的压力。
为了能够延长局部负压的施加,已经开发了包括真空产生源如泵的动力系统。然而,这些系统中的许多系统对使用者来说并不方便,因为它们可能很大、很重、嘈杂、不舒适,而且使用者很难正确应用和操作。此类系统还依赖于外部电源或真空源来产生规定的负压条件。
鉴于人口老龄化以及越来越多受损患者群体的出现,负压伤口和组织治疗以及其它先进的技术干预变得越来越普遍。这种趋势看起来将继续下去。在伤口护理中,医疗保健专业人员现在更有可能遇到难以处理的伤口以及许多复杂的愈合问题。
虽然在负压疗法的应用中已经使用了几种方法来处理伤口,但是这些方法存在诸多问题。例如,现有技术中负压伤口敷料的一个问题是它们经常在敷料周边发生泄漏。相关地,发生泄漏的负压伤口敷料需要更强劲的泵,这又需要显著更大的能量(通常是电能)输入,以在伤口部位维持可接受的减压量。此类敷料的另一个问题涉及敷料不能吸收并保留可接受量的来自伤口部位的引流液和渗液以促进足够的愈合环境。此外,许多现有技术负压伤口敷料作为一组多个零件或部件提供,在将敷料施用到伤口上方时需要经由多个施用步骤组装所述零件或部件,这通常导致敷料的不正确应用和/或装置的不可操作性。所有这些问题都降低了规定的负压伤口治疗的有效性,从而导致伤口愈合环境欠佳。
仍然需要负压伤口敷料,其易于施用至伤口部位,以整体敷料构造的形式提供,并且提供改进的密封以在功率需求降低的情况下在伤口部位维持可接受的负压。本公开解决了这些需求并提供了其它好处和优点。
发明内容
本公开提供了负压伤口敷料和包括负压伤口敷料的装置。在本公开的一个方面,提供了一种整体式负压伤口敷料结构,其包括:(i)具有用于接触伤口的第一表面和与所述第一表面相对的第二表面的吸收层,该吸收层包括胶凝吸收材料并且具有周边边界,(ii)覆盖层,该覆盖层具有面向吸收层的第一表面和与第一表面相对的第二表面,其中该覆盖层具有周边边界,该周边边界的尺寸大于吸收层的周边边界的尺寸,使得覆盖层的周边边界延伸超出吸收层的周边边界,和(iii)邻近吸收层的周边边界附接到吸收层的第一表面上的周边粘性皮肤接触层,其中该周边粘性皮肤接触层限定了窗口,吸收层能够通过该窗口接触伤口,并且其中周边粘性皮肤接触层包括水胶体粘合剂。在一些实施例中,吸收层的周边边界的尺寸大于将被敷料覆盖的伤口的尺寸。在一些实施例中,其中覆盖层是不透水的。在一些实施例中,覆盖层是不透水但能透空气和蒸气的。在一些实施例中,周边粘性皮肤接触层具有周边边界,该周边边界的尺寸大于吸收层的周边边界的尺寸,使得周边粘性皮肤接触层的周边边界延伸超出吸收层的周边边界。在一些实施例中,覆盖层的周边边界和周边皮肤接触层的周边边界结合在一起以形成密封部。在一些实施例中,周边粘性皮肤接触层能操作成附着到伤口周围的皮肤上。在一些实施例中,覆盖层限定了构造成用于连接到负压源的孔洞。
在一些实施例中,当将敷料施加在伤口上方并且将负压源密封地连接到孔洞时,周边粘性皮肤接触层和覆盖层可操作以在吸收层与敷料的外部环境之间形成气密/不透空气的密封。在一些实施例中,周边粘性皮肤接触层具有约0.1mm至约5mm的厚度。在一些实施例中,周边粘性皮肤接触层具有约2cm至约6cm的宽度。
在一些实施例中,敷料还包括位于吸收层与覆盖层之间的第一结合层。在一些实施例中,第一结合层包括水胶体粘合剂层。在一些实施例中,第一结合层具有约0.2mm至约2mm的厚度。
在一些实施例中,敷料还包括与周边粘性皮肤接触层对应并且具有与所述周边粘性皮肤接触层结合的第一表面的结构层,以及与周边粘性皮肤接触层对应并且定位成与结构层的与其第一表面相对的第二表面接触的第二结合层。在一些实施例中,结构层位于周边粘性皮肤接触层与第二结合层之间,并与周边粘性皮肤接触层和第二结合层密封地结合。在一些实施例中,第二结合层与吸收层的第一表面的与吸收层的整个周边边界相邻的连续部分密封地结合。在一些实施例中,周边粘性皮肤接触层、第二结合层和覆盖层可操作成在敷料被施用在伤口上方并且负压源被密封地连接到孔洞时在吸收层与敷料的外部环境之间形成气密密封。在一些实施例中,结构层包括聚氨酯膜。在一些实施例中,第二结合层具有约0.2mm至约2mm的厚度。
在一些实施例中,敷料还包括位于吸收层与覆盖层之间的第一结合层、与周边粘性皮肤接触层对应并且具有与粘性皮肤接触层结合的第一表面的结构层以及与周边粘性皮肤接触层对应并且定位成与结构层的与其第一表面相对的第二表面接触的第二结合层。在一些实施例中,结构层位于周边粘性皮肤接触层与第二结合层之间,并且与周边粘性皮肤接触层和第二结合层密封地结合。在一些实施例中,第二结合层与吸收层的第一表面的与吸收层的整个周边边界相邻的连续部分密封地结合。
在一些实施例中,胶凝吸收材料包括凝胶形成纤维或细丝。在一些实施例中,凝胶形成纤维或细丝包括化学改性的纤维素、藻酸盐、羧甲基纤维素或其组合。在一些实施例中,吸收层包括线迹。在一些实施例中,吸收层还包含抗微生物剂。在一些实施例中,覆盖层包括选自由聚氨酯(PU)、聚氯乙烯(PVC)、聚硅氧烷弹性体、含氟聚合物及其组合组成的群组的成员。
在一些实施例中,敷料还包括负压源,该负压源与孔洞密封地连接并与吸收层流体连通。在一些实施例中,负压源包括连接到孔洞的泵。在一些实施例中,泵通过导管连接到孔洞。在一些实施例中,敷料还包括连接器,该连接器在孔洞上方附接到覆盖层并且构造成用于连接到导管以将负压从导管通过孔洞传输到伤口。在一些实施例中,连接器包含聚氨酯或聚氯乙烯。在一些实施例中,连接器包括更换指示器。
在一些实施例中,敷料还包括位于吸收层与覆盖层之间的负压分布层。在一些实施例中,负压分布层包括开孔泡沫层。在一些实施例中,该开孔泡沫层是疏水的。
在本公开的另一个方面,提供了一种一次性的负压伤口治疗装置,该一次性负压伤口治疗装置包括用于产生负压的一次性泵以及根据本文公开的任何实施例的用于覆盖和保护伤口的敷料,其中所述覆盖层限定连接到泵的孔洞。在一些实施例中,一次性泵是电池供电的泵。在一些实施例中,该装置还包括限定管腔的导管,该管腔提供泵与限定在敷料的覆盖层中的孔洞之间的流体连通,由此当通过将周边粘性皮肤接触层加压密封到伤口周围的皮肤上以将敷料固定到伤口上方时,泵的运行在伤口部位处产生负压。
本公开的更多特征、特点和实施例将从文中的详细描述中变得显而易见。
结合引用
通过引用将本说明书中提到的所有公报、专利和专利申请并入本申请中,合并范围与每个单独的公报、专利或专利申请特别地和单独地表示为通过引用被合并相同。
附图说明
图1示出了根据本公开的一个敷料实施例的示意性俯视图。
图2示出了图1所示的敷料实施例的截面侧视图。
图3示出了图1所示敷料实施例的另一截面侧视图。
图4示出了根据本公开的另一个敷料实施例的示意性俯视图。
图5示出了图4所示的敷料实施例的截面侧视图。
图6示出了图4所示的敷料实施例的另一截面侧视图。
图7示出了根据本公开的另一个敷料实施例的截面侧视图。
图8示出了图7所示的敷料实施例的另一个截面侧视图。
应当理解的是,附图不一定按比例绘制且所公开的实施例有时被概略性地且在局部视图中示出。在某些情况下,可能省略了对于理解所公开的方法和装置而言不必要或使得其它细节难以认知的细节。还应理解,本公开不限于本文说明的特定实施例。
具体实施方式
为了促进对本发明原理的理解,现在将参考文中描述并在图中示出的实施例,并且将使用特定语言来描述它们。以下描述的本申请的实施例并非旨在是详尽的或将本申请的教导限制为在以下详细描述中公开的精确形式。相反,实施例被选择和描述以使得本领域的其它技术人员可以了解和理解本申请的原理和实践。因此应当理解,对特定实施例的描述并非旨在限制本发明的范围。所描述的实施例中的任何变更和进一步的修改,以及如本文描述的本发明的原理的任何进一步的应用,都是本发明所涉领域的技术人员通常会想到的。
本公开解决了与现有技术中的负压伤口敷料相关的问题和挑战,例如密封不良、复杂的现场组装等,其提供了新型负压伤口敷料构造,特征在于具有牢固密封性和出色的流体吸收特性的整体结构。
本公开的一个方面是一种敷料,该敷料包括包含胶凝吸收材料的吸收层、覆盖在吸收层上的由不透水但能透空气和蒸气的材料组成的覆盖层以及位于吸收层的周边边缘下方以将敷料密封地固定到患者的皮肤上的周边粘性皮肤接触层。如上一句中所用,用语“下方”是指“在皮肤覆盖层的相对侧”。周边粘性皮肤接触层包含水胶体粘合剂。覆盖层限定了构造成用于连接到负压源的孔洞。
本文公开的敷料特别适用于真空和/或负压伤口治疗,但也可替代地用于其它情形,包括但不限于用于其它产生渗液或流体的情形。
真空伤口疗法可用于治疗多种伤口类型,包括但不限于急性伤口(例如,筋膜切开术或其它手术后)、慢性伤口(例如压疮、营养性和血管性溃疡)以及复杂软组织损伤的处理(例如开腹(剖腹手术))。
特定术语
除非另外限定,否则本文所使用的所有技术和科学术语具有与本公开的主题所属领域的技术人员通常理解的相同的含义。此外,应当理解,当本文结合本教导的各种实施例列举某些值和范围时,落入这些列出的值和范围之间的所有值和范围旨在被本教导所涵盖,除非另有明确说明。最后,虽然本文针对本公开的某些代表性方面描述了具体方法和材料,但应当理解和了解,与本文所述的那些相似或等效的其它方法和材料可用于本申请的实践或测试而不偏离本公开的预期范围。
应当理解,以下一般描述和以下示例仅是说明性的,而不是对要求保护的任何主题的限制。还应理解的是,虽然对在以上描述中采用的诸如优选、优选地、优选的或更优选的这样的词语的使用表明如此描述的特征可能是更可取的,但它可能不是必需的,并且可以将缺少它的实施例视为处于本发明的范围内,该范围由附后权利要求限定。在本申请中,除非另有明确说明,否则单数的使用包括复数。必须注意,如在说明书和所附权利要求中所使用的,单数形式“一”、“一种”和“该”包括复数指示物,除非上下文中明确表示其它情况。在本申请中,除非另有说明,否则“或”的使用是指“和/或”。此外,术语“包含”、“包括”和“具有”以及其它形式例如“包含”、“包含有”、“被包含”、“包括”、“包括有”、“被包括”、“具有”和“有”的使用是包含性的而不是限制性的,因此指定了所述及的特征、整数、步骤、操作、元件和/或部件的存在,但不排除一个或多个其它特征、整数、步骤、操作、元件、部件和/或它们的群组的存在或增加。本文所述的方法动作、过程和操作不应被解释为必然要求它们以所讨论或图示的特定顺序执行,除非具体标识为执行顺序。还应理解,可以采用附加的或替代的动作或操作。
尽管本文中可以使用术语第一、第二、第三等来描述各种元件、部件、区域、层和/或区段,但是这些元件、部件、区域、层和/或区段不应受限于这些术语。这些术语可以仅用于将一个元件、部件、区域、层或区段与另一区域、层或区段区分开。诸如“第一”、“第二”等数字术语当在本文中使用时并不暗示顺序或次序,除非上下文明确指出。因此,本文所讨论的第一元件/部件/区域/层或区段可以被称为第二元件/部件/区域/层或区段而不脱离示例性实施例的教导。
如本文所用,范围和量可以表示为“约”特定值或范围。“约”还包括确切的量。例如,“约5μL”指“约5μL”,也指“5μL”。一般而言,术语“约”包括预期在实验误差内的量。术语“约”包括比所提供的值小10%至大10%以内的值。例如,“约50%”指“介于45%与55%之间”。此外,举例而言,“约30”指“介于27与33之间”。
本文使用的章节标题仅用于组织目的并且不应被解释为限制所描述的主题。
如本文所用,术语“个体”、“受试者”和“患者”是指任何哺乳动物。在一些实施例中,哺乳动物是人类。在一些实施例中,哺乳动物是非人类。
术语“渗液”是指由伤口产生的可能从伤口分泌的任何流体。
术语“伤口周围”是指直接与伤口区域本身交界的区域。术语“皮肤周围”是指直接与伤口区域本身交界的皮肤区域。
如本文所用的术语“负压”和“减压”一般指的是低于正经受治疗的组织部位处的环境压力的压力。在大多数情况下,该降低的压力将小于患者所处的大气压力。或者,减压可以小于与组织部位处的组织相关的静水压力。尽管术语“真空”和“负压”可用于描述施加到组织部位的压力,但施加到组织部位的实际压力降低可能显著小于通常与完全真空相关的压力降低。
如本文所用,术语“可模制的”是指弹性、可变形的性质和顺应和/或形成密封的能力。本文所公开的各种实施例的可模制材料可以不同于可拉伸的柔性材料。术语“可模制”可涵盖延展性和可锻性的特性。可模制材料的绝对形状变化可以由外部抵抗元件控制,从而符合互补特征。
如本文所用,术语“柔性”是指结构在外力作用下的弹性变形。移除外力后,该结构将基本恢复到其原始(先前)几何形状。柔韧度的测量可以用线性位移(μm,mm,cm,m)来量化,例如,原始长度/直径和变形(flexed)长度/直径。面积的二阶矩会影响物体所经历的变形。可模制的装置也可以具有柔韧性的特性。敷料需要柔韧性。皮肤在日常生活的运动和活动中弯曲变形,尤其是在关节组织上的区域中。刚性系统将无法持续适应皮肤的柔韧性。然而,柔性装置能够不断适应皮肤和粘膜的柔韧性。
如本文所用的通用术语“粘合剂”是指用于促进敷料粘附到皮肤上和/或促进敷料各层彼此之间的密封,从而防止不希望的流出物泄漏并为施加负压提供有效环境的层、织物、条、层压件、屏障和材料。
敷料
本文描述了适合与负压伤口疗法结合使用的敷料的若干代表性实施例。首先参考图1-3,敷料100包括吸收层110、覆盖层120和周边粘性皮肤接触层130。虽然本文公开的敷料可具有多种形状和尺寸,但为了方便描述,图1-3中描绘的敷料100具有长度尺寸为L和宽度尺寸为W的大致矩形形状。吸收层110具有用于接触伤口的第一表面112和与第一表面112相对的第二表面114,并且具有周边边界116,该周边边界116的尺寸优选地大于将由敷料100覆盖的伤口的尺寸。覆盖层120具有面向吸收层110的第一表面122并具有与第一表面122相对的第二表面124,并且具有延伸超出吸收层110的周边边界116的周边边界126。照此,周边边界126的尺寸大于吸收层110的周边边界116的尺寸。周边粘性皮肤接触层130邻近吸收层110的周边边界116附接到吸收层110的第一表面112上。周边粘性皮肤接触层130具有限定了窗口134的内边缘132,吸收层110的第一表面112能够穿过该窗口134接触其上被施加敷料100的伤口。
在一些实施例中,覆盖层120的第一表面122通过粘合剂与吸收层的第一表面114结合。在另一些实施例中,覆盖层120的邻近其周边126的至少一部分与吸收层110的邻近其周边116的一部分结合。在一些实施例中,通过在吸收层110与覆盖层120之间设置结合层来使覆盖层120的第一表面122与吸收层的第一表面114结合。在一些实施例中,结合层包括粘合剂。在一些实施例中,结合层包括一层水胶体粘合剂。
敷料100构造成通过周边皮肤接触层130保持在伤口上方的适当位置,该周边皮肤接触层130围绕敷料的边界延伸并限定穿过其中的窗口。周边粘性皮肤接触层130由能够持久且牢固地粘附到皮肤上以形成密封的材料构成。敷料粘附到患者皮肤上的耐久性是在应用负压伤口疗法期间防止不可接受的渗漏水平的一个重要因素。普通技术人员理解,这种耐久性与影响周边粘性皮肤接触层与下方皮肤之间的粘附强度的用于制造周边皮肤接触层130的组合物的性质成正比,并且也与周边粘性皮肤接触层130的宽度W1成正比。在一个实施例中,周边粘性皮肤接触层130具有约1cm至约10cm的宽度。在另一实施例中,周边粘性皮肤接触层130具有约2cm至约6cm的宽度。在又一实施例中,周边粘性皮肤接触层130具有约2cm至约5cm的宽度。
周边粘性皮肤接触层130和覆盖层120能操作成在敷料100被施用在伤口上方并且负压源被密封地连接到孔洞128时在吸收层与敷料100的外部环境之间形成气密密封。
当制造敷料100(或本文公开的任何其它敷料)时,可将本文称为“可移除背衬”(未示出)的可移除膜粘附到周边粘性皮肤接触层130的外表面(也称为“底面”)上,该可移除背衬在敷料100使用前将被移除。参考图1-3,在一个实施例中,可移除背衬可粘附到周边粘性皮肤接触层130的外表面上,该外表面与周边粘性皮肤接触层130的面向覆盖层126的一侧相对。可移除背衬可以包括多个区段并且可以包括折叠的抓握区段,该可移除背衬在敷料100使用前可从周边粘性皮肤接触层130上移除。因此,在一优选实施例中,当将可移除背衬粘附到周边粘性皮肤接触层130上时,可移除背衬保护周边粘性皮肤接触层130,但是当将可移除背衬从周边粘性皮肤接触层130上移除以使用敷料100时,周边粘性皮肤接触层130的外表面被暴露并且能够将敷料100可释放地固定到使用者的皮肤上以在伤口周围提供可变形的加压密封。在一些实施例中,可移除背衬还确定尺寸为覆盖敷料100的整个底面,包括周边粘性皮肤接触层130的底面以及任何其它层的任何暴露部分,比方说,例如吸收层110的通过窗口134暴露的部分。
吸收层
吸收层110由胶凝吸收材料组成。胶凝吸收材料优选地能够吸收来自伤口的渗液并允许流体通过它。吸收层110可以具有开放式编织结构,带有可用于流体吸收的凹穴。在另一些实施例中,吸收层可以是非织造的、针织的或由紧密编织物形成。在一些实施例中,吸收层是无纺布。吸收层可在吸收从伤口部位产生的渗液或其它流体时膨胀。
在一些实施例中,吸收层包括凝胶形成纤维、细丝(filament)或制剂。在一些实施例中,凝胶形成纤维或细丝是化学改性的纤维素、藻酸盐或羧甲基纤维素,或其组合。在一些实施例中,凝胶形成纤维是羧甲基纤维素。吸收层还可包括其它吸收材料,例如聚丙烯酸酯、聚丙烯酸酯纤维、双组分超吸收纤维、气流成网无纺布、针刺无纺布、热粘合无纺布和泡沫。
吸收层的一些配方包含藻酸盐以增加吸收能力。吸收层的活性表面可以涂有交联的粘合剂物质,该粘合剂物质包含明胶、果胶和/或羧甲基纤维素以及其它聚合物的分散体。与传统敷料接触时,多糖和其它聚合物会吸收水分并鼓胀,从而形成凝胶。敷料下方产生的潮湿环境旨在促进纤维蛋白溶解、血管生成和伤口愈合,而不会导致组织软化和分解。
吸收层110优选地包括凝胶形成纤维。凝胶形成(纤维)是指吸湿性纤维,其在吸收伤口渗液时变得湿滑或凝胶状,从而降低周围纤维附着到伤口上的趋势。凝胶形成纤维可属于在吸收渗液时保持其结构完整性的类型,或者可属于失去其纤维形式并变成无结构凝胶的类型。凝胶形成纤维优选为纺成羧甲基纤维素钠纤维、化学改性纤维素纤维、果胶纤维、藻酸盐纤维、壳聚糖纤维、透明质酸纤维或其它多糖纤维或从树胶衍生的纤维。凝胶形成纤维优选为羧甲基纤维素钠纤维、化学改性纤维素纤维、烷基磺酸盐改性纤维素纤维(例如WO 2012/061225中描述的那些)、果胶纤维、藻酸盐纤维、壳聚糖纤维、透明质酸纤维或其它多糖纤维或从树胶衍生的纤维。凝胶形成纤维优选为织物形式的化学改性纤维素纤维,特别是如Azko Nobel UK Ltd名下的PCT WO00/01425中所述的羧甲基化纤维素纤维。纤维素纤维优选每个葡萄糖单位具有至少0.05个羧甲基基团的取代度。在另一实施例中,纤维素纤维具有约0.12至约0.35的取代度,如通过IR光谱法(如WO 00/01425中所定义)测定的。在另一实施例中,纤维素纤维具有约0.20至约0.30的取代度并通过将织造的、针织的或非织造的纤维素织物羧甲基化以增加吸收性来制备。凝胶形成纤维优选具有每克纤维至少2克0.9%盐水溶液的吸收性(通过自由溶胀法测量)。
优选地,凝胶形成纤维在使用自由溶胀吸收法测量时具有至少10g/g、更优选地在15g/g与25g/g之间的吸收度。
胶凝吸收材料可以按照WO 93/12275的公开内容制备,该公开内容描述了能够吸收其自身重量许多倍的水的各种吸收性羧甲基化纤维素产品的制备。这致使羧甲基化纤维形成凝胶。WO 94/16746和WO 00/01425描述了羧甲基化莱赛尔纤维材料在伤口敷料中的用途,其中描述了凝胶形成在防止粘附并因此减少伤口损伤和移除时疼痛方面的优点。
羧甲基化可以例如通过用强碱如氢氧化钠水溶液和一氯乙酸或其盐顺序或同时处理纤维素材料来实现。合适的反应条件将取决于织物的组成和所需的羧甲基化程度,这对本领域技术人员来说是显而易见的。它们可以与WO 93/12275、WO 94/16746或WO 00/01425中描述的那些相同或相似。理想地,羧甲基化在工业甲基化酒精(IMS)的存在下进行,并且IMS也优选在随后的洗涤步骤中使用,适当地与水一起,作为清洁剂和消毒剂。羧甲基化的程度理想地使得在吸收渗液后,绷带的皮肤接触表面处的纤维形成凝胶。
在一些实施例中,吸收层110包括形成为织物的羧甲基化纤维素纤维。在另一些实施例中,吸收层110包括两层或更多层包含羧甲基化纤维素纤维的织物。在一个实施例中,吸收层110包括约两层至约十层包括羧甲基化纤维素纤维的织物。在另一实施例中,吸收层110包括约两层至约八层包括羧甲基化纤维素纤维的织物。
在吸收层110包括一层或多层包括羧甲基化纤维素纤维的织物的一个实施例中,吸收层110还包括线迹部(stitching)以提高敷料100的拉伸强度和/或弹性。在包括多于一层包括羧甲基化纤维素纤维的织物的吸收层中,线迹部可以仅存在于一层或多于一层的织物中。在一个实施例中,线迹部存在于被定位成在使用敷料100时接触伤口的织物层中。
本公开所设想的线迹部可包括非弹性线或纱线和/或弹性线或纱线。WO 2007/003905描述了其中使用线迹部来提高敷料的拉伸强度的敷料,该敷料特别适用于烧伤敷料。US 10,117,783描述了其中使用线迹部来提高敷料弹性的敷料,该敷料特别适用于放置在身体上发生运动的位置如关节(例如,肘部、膝盖、臀部等)或腹部上的敷料。
弹性是指纱线或线能够伸长和收缩到其先前的形状。由弹性线或纱线形成的吸收层中的褶裥使吸收层能够随着运动而伸长和收缩,使得例如当患者的腿弯曲时,敷料会拉伸,而当腿伸直时,敷料会恢复其原有的大小。这种弹性意味着吸收层在患者移动期间与伤口保持紧密贴合。这也意味着敷料在穿着过程中分层的趋势降低。具有拉伸能力意味着敷料与患者之间的运动较少,从而使敷料与患者的下方皮肤之间的密封能够更加持久。
优选地,吸收层还包括由非弹性线形成的纵向经线线迹(warp stitch),该线迹部是纵向的,因为它大致平行于吸收层的纵长尺寸。经线线迹优选在吸收层已形成之后在吸收层中形成。
非弹性经线线迹部优选地穿过吸收层的整个厚度并且在两侧是可见的。吸收层优选地包括两层或更多层织物,它们层叠在一起并用纵向非弹性经线线迹线缝合结合。弹性线优选地被编织在非弹性经线线迹部的线迹之间以及织物片之间。通过具有两层织物,可以使弹性线或纱线不与伤口直接接触。
弹性线聚拢吸收层并使其伸长然后恢复形状。弹性线可以穿过吸收层被缝合以聚拢敷料或通过单独的非弹性经线线迹编织。弹性线可以以隔开1mm至10mm、更优选地隔开2mm至5mm的纵向线迹线穿过吸收层被缝合。弹性线优选地在吸收层已形成之后被施加至吸收层。
非弹性经线线迹部的线可以隔开1mm至10mm,优选地隔开2mm至5mm。非弹性线迹部的线通常是钩编或针织的,并且具有链式线迹的外观,但也可以使用其它线迹图案。优选地,弹性线迹部的线聚拢吸收层,使得吸收层能够伸长25%至85%,更优选35%至75%,最优选40%至70%,然后恢复,即使吸收层是水合的。更优选地,经线线迹部的线由纱线或诸如尼龙或聚酯或(Lenzing Aktiengesellschaft)的线或任何坚固且易于加工的线制成。弹性线迹由弹性纱线——例如弹性体纱线,或莱卡,或具有良好拉伸和回复性的其它纱线,或包含大于85%的聚氨酯的弹性纱线如(莱卡公司)或氨纶——制成。
在制造吸收层110的一种代表性方式中,吸收层110由非织造辊制成,该非织造辊是通过形成莱赛尔纤维幅材然后水刺而制成的。然后通过用强碱、一氯乙酸或其盐顺序或同时对纤维素材料进行处理来使幅材羧甲基化。然后将所得织物的两个幅材送入缝编机中,并同时用非弹性纱线的纵向线迹以及在线迹之间编织并因此固定在幅材中心处的弹性纱线进行缝合。弹性纱线聚拢吸收层(未示出)并由非弹性缝编纱线承载。所得层的基重为350gm-2。
在制造吸收层110的另一代表性方式中,吸收层110由已经针刺的羧甲基纤维素丝束制成。将两个针刺丝束的幅材送入缝编机中,并同时用非弹性纱线的纵向线迹部的线和在线迹之间编织并因此被固定在幅材中心处的弹性纱线进行缝合。
在一个实施例中,吸收层110设有开窗以帮助对伤口施加负压并保持供流体从伤口通过吸收层的通路。然而,通常仅在内部吸收层中设置开窗。外部吸收层,包括与伤口直接接触的那些,通常没有机械地添加的开窗,然而,它们在纤维之间确实具有开口。
吸收层110可以包括一种或多种药物。例如,抗菌剂,或抗生素,或抗炎剂上的麻醉剂或皮肤保护剂或气味吸收剂。在一些实施例中,吸收层包括可抑制革兰氏阴性菌和/或革兰氏阳性菌生长的抗微生物剂。抗菌剂可杀死微生物、抑制微生物的生长周期或破坏微生物生物膜的形成。抗菌剂抑制细菌的生长,从而促进健康的伤口愈合。
覆盖层
覆盖层120可以是提供流体密封的任何材料。如果涉及特定减压源或子系统,那么流体密封是足以在所需部位维持减压的密封。例如,覆盖层可以是不渗透或半渗透的弹性体材料。对于半渗透性材料,渗透性必须足够低,以便对于给定的减压源,可以维持所需的减压。覆盖层可以是防水的。在一些实施例中,覆盖层包括聚酯、聚氨酯(PU)、聚氯乙烯(PVC)、硅弹性体或含氟聚合物。在一些实施例中,覆盖层可以包括聚酯或聚氨酯膜。
覆盖层120适于实现在伤口处施加负压并限定穿过其中的孔洞,该孔洞构造成用于连接到负压源。在一个实施例中,该孔洞包括构造成用于附接到导管上的端口,该导管进而构造成用于附接到负压源上。敷料提供从伤口经吸收层和孔洞到导管的流体通路。该端口优选地位于覆盖层的覆盖吸收层但朝向吸收层周边的那部分中,使得它不直接与敷料(或使用时的伤口)的中心垂直对齐。这有助于渗液在吸收层的整个范围内扩散。
在一个实施例中,敷料100的覆盖层120是细菌和病毒阻挡层,其优选地抵抗液体和空气的进入但允许湿气透过。这样,外覆盖层通过允许湿气经覆盖层逸出同时能够对伤口施加负压来增强敷料的整体流体处理能力。外覆盖层例如是具有每24小时至少10,000gm-2的湿气透过率(MVTR)或在每24小时10,000gm-2至50,000gm-2的范围内的湿气透过率(MVTR)的层,所述湿气透过率通过BS EN 13726-2 2002的《Test methods for primarywound dressings Part 2Moisture vapour transmission rate of permeable filmdressings》中描述的方法测量。覆盖层可以是聚氨酯膜的形式,例如由Covestro制造的Epurex 92T/129或由Coveris制造的Inspire2350或由Mylan制造的Medifilm 426。
周边粘性皮肤接触层
周边粘性皮肤接触层130可以属于例如在通过引用并入本文的EP-B-92999中描述的包括一种或多种水溶性水胶体(hydrocolloid)和一种或多种低分子量聚异丁烯的均匀共混物的类型。水溶性水胶体可以选自羧甲基纤维素钠、果胶、明胶、瓜尔豆胶、刺槐豆胶、刺梧桐胶以及它们的混合物。聚异丁烯可以选自粘均分子量为36,000至58,000(Florey)的低分子量聚异丁烯。周边粘性皮肤接触层能够吸收渗液,同时保持敷料对皮肤的粘附。
可替代地,粘合剂组合物可以包括一种或多种水胶体、一种或多种低分子量聚异丁烯、一种或多种苯乙烯嵌段共聚物、矿物油、丁基橡胶、增粘剂和少量任选组分的均匀共混物。通过选择以上列出的组分的具体用量范围,可以制备对皮肤具有良好粘附性和拉伸性的粘合剂组合物。因此,此类组合物和制备公开于EP-B-130061中。
优选地,周边粘性皮肤接触层130的组成使得粘性伤口敷料的移除不会对患者造成创伤。优选地,周边粘性皮肤接触层确保敷料的牢固施用,同时仍允许非创伤性移除。可以通过使用在与流体相互作用时轻微凝胶化的粘合剂来促进非创伤性敷料移除。凝胶的形成有助于移除敷料。
如本文所用,术语“水胶体粘合剂”是指包括水胶体的粘合剂材料或物质。可以调节这些粘合剂的配方以调整材料的物理特性(例如,其产生真空密封的能力、柔韧性、透气性、舒适性、尺寸等)。
在一些实施例中,周边粘性皮肤接触层的按重量百分比(w/w)计至少1%、至少5%、至少10%、至少15%、至少20%、至少30%、至少40%、或至少50%为水胶体。
周边粘性皮肤接触层130可操作以在周边粘性皮肤接触层与皮肤之间提供密封,从而防止渗液泄漏。
在本文公开的一些实施例中,周边粘性皮肤接触层具有约0.1mm至约5mm的厚度。在另一些实施例中,皮肤接触层具有约0.15mm至约3mm的厚度。在又一些实施例中,皮肤接触层具有约0.2mm至约2mm的厚度。
在另一些实施例中,敷料中包括另外的结构层和/或结合层。参考图4-6,敷料200包括与敷料100的特征相对应的许多特征,并且还包括第一结合层240、加强结构支承层250(也称为结构层250)和第二结合层260。第一结合层240位于覆盖层220与吸收层210之间并用于将覆盖层220附着到吸收层210上。结构层250覆盖周边粘性皮肤接触层230并用作稀松布以增加周边粘性皮肤接触层230的稳定性。结构层240有助于减少周边粘性皮肤接触层230在移除敷料时分层的任何趋势。第二结合层260覆盖在结构层250上,以使结构层250和下方的周边粘性皮肤接触层230与吸收层210结合。如图6中最清楚地示出的,第二结合层260和结构层250还限定了从其中切开的窗口,该窗口与周边粘性皮肤接触层230中的窗口234重合,以使吸收层210和下方的伤口之间能够直接接触。
吸收层210具有用于接触伤口的第一表面212和与第一表面212相对的第二表面214,并且具有周边边界216,该周边边界216的尺寸大于将由敷料200覆盖的伤口的尺寸。覆盖层220具有面向吸收层210的第一表面222并具有与第一表面222相对的第二表面224,并且具有延伸超过吸收层210的周边边界216的周边边界226。照此,周边边界226的尺寸大于吸收层210的周边边界216的尺寸。第一结合层240定位在覆盖层220的第一表面222与吸收层210的第二表面214之间。结构层250和第二结合层260位于周边粘性皮肤接触层230与吸收层210的邻近其周边边界216的第一表面212之间,定向成使得结构层250邻近周边粘性皮肤接触层230并与其结合,并且第二结合层260位于结构层250与吸收层210的第一表面212之间,从而使结构层250在吸收层210的周边边界216的区域内与吸收层210结合。周边粘性皮肤接触层230具有与结构层250和第二结合层260的内边缘重合的内边缘232,从而一起限定窗口234,吸收层210的第一表面212能够穿过该窗口234以接触敷料200被施用于其上的伤口。
如在图5和6中最清楚地示出的,在周边边界216和226之间的区域290中,周边粘性皮肤接触层230与结构层250结合,结构层250与第二粘合剂层260结合,第二粘合剂层260与第一粘合剂层240结合,第一粘合剂层240与覆盖层220结合。在这些层如图所示结合在一起的情况下,当将周边皮肤接触层230固定到伤口周围的患者皮肤上时,周边皮肤接触层230、结构层250、第二结合层260和第一结合层240连同覆盖层220和患者皮肤一起在敷料200的周边形成气密密封,从而在其中提供密封腔室,患者的伤口在该腔室中与吸收层210并与覆盖层220中的孔洞228流体连通。
结构层
在一些实施例中,结构层250包括选自但不限于聚环氧丙烷、聚氨酯、聚丙烯酸酯、乙烯醋酸乙烯酯和其组合的聚合物。在一些实施例中,聚合物形成薄膜。在一些实施例中,结构层包括聚氨酯膜。
第一结合层
在一些实施例中,第一结合层240包括粘合剂。在一些实施例中,结合层240包括水胶体粘合剂,例如果胶、明胶、NaCMC-羧甲基纤维素钠。粘合剂可以按重量百分比(w/w)计至少1%、至少5%、至少10%、至少15%、至少20%、至少30%、至少40%或至少50%为水胶体。第一结合层240可以由与周边粘性皮肤接触层230相同的水胶体粘合剂构成,或者可以由与周边粘性皮肤接触层230不同的粘合剂构成。
在一些实施例中,第一结合层240具有约0.1mm至约5mm的厚度。在一些实施例中,第一结合层240具有约0.2mm至约3mm的厚度。在一些实施例中,第一结合层240具有约0.2mm至约2mm的厚度。在一些实施例中,第一结合层240具有0.2mm至约1mm的厚度。
第二结合层
在一些实施例中,第二结合层260包括粘合剂。在一些实施例中,第二结合层260包括水胶体粘合剂,例如果胶、明胶、NaCMC-羧甲基纤维素钠。粘合剂可以按重量百分比(w/w)计至少1%、至少5%、至少10%、至少15%、至少20%、至少30%、至少40%或至少50%为水胶体。第二结合层260可以由与周边粘性皮肤接触层230相同的水胶体粘合剂构成,或者可以由与周边粘性皮肤接触层230不同的粘合剂构成。
在一些实施例中,第二结合层260具有约0.1mm至约5mm的厚度。在一些实施例中,第二结合层260具有约0.2mm至约3mm的厚度。在一些实施例中,第二结合层260具有约0.2mm至约2mm的厚度。在一些实施例中,第二结合层260具有0.2mm至约1mm的厚度。
在本公开的另一些实施例中,敷料中包括负压分布层。参考图7和8,敷料300包括与敷料100和200的特征对应的许多特征,并且还包括定位在吸收层310与覆盖层320之间的负压分布层370。在所示实施例中,第一结合层340位于负压分布层370与覆盖层320之间。然而,应当理解,敷料300中(和本文描述的其它敷料实施例中)在所示各层之间可以包括另外的层而不脱离本公开。例如,在一个实施例(未示出)中,负压分布层370定位在吸收层310内,或者,换一种说法,敷料300包括两个吸收层,一个如图7和8所示定位(吸收层310),另一个完全或部分地定位在压力分布层370与覆盖层320之间。在这样的实施例中,两个吸收层都可以由如本文中结合吸收层110、210、310描述的材料组成,并且可以具有彼此相同的组成或彼此不同的组成。在这样的实施例中,如果需要,还可以包括一个或多个另外的结合层(未示出),以在敷料内实现各层之间可接受的结合。
在装置300中,负压分布层370具有与吸收层310的长度和宽度尺寸相对应的长度和宽度尺寸。在另一些实施例中,负压分布层370具有与吸收层310不同的尺寸。在各层如图所示结合在一起的情况下,当周边皮肤接触层330被固定到患者伤口周围的皮肤上时,负压分布层370也与吸收层310一起位于敷料300的由周边皮肤接触层330、结构层350、第二结合层360和第一结合层340连同覆盖层320和患者皮肤一起形成的气密密封腔室内。在该腔室内,患者的伤口与吸收层310、负压分布层370和覆盖层320中的孔洞228流体连通。
负压分布层
在一些实施例中,负压分布层370可渗透气体和液体,尤其是可渗透湿气,并且用于通过在敷料300上横向分布负压并允许渗液在负压分布层370下方扩散来帮助渗液进入吸收层310的更大面积。负压分布层370还用于使在整个敷料上施加至伤口的负压均匀。负压分布层370优选地在敷料上分布渗液和负压。这样,使吸收层310对渗液的吸收最大化并且负压更均匀地传递到伤口或敷料300得以优化。
在一些实施例中,负压分布层370是泡沫层,例如由Caligen制造的XD4200AS型聚酯泡沫或另一种合适的网状泡沫。在另一些实施例中,负压分布层370可包括任何合适的材料或由任何合适的材料形成,例如,可允许将负压输送到伤口部位和/或可以引导和/或依靠毛细作用带动(wick)伤口流体和/或伤口碎片远离伤口部位的材料。例如,负压分布层370可以包括选自由非织造材料、聚合物和其组合组成的群组的材料或由这种材料形成。在一些实施例中,负压分布层370可以由非织造材料形成。非织造材料可包括天然纤维、合成纤维、连续纤维、切断纤维(staple fiber)、不连续纤维、双组分纤维和其组合。在一些实施例中,非织造材料可以包括聚烯烃纤维(例如聚丙烯、聚乙烯)、聚酯、聚对苯二甲酸乙二醇酯(PET)、尼龙、棉、及其组合和共聚物。非织造材料可由本领域已知的各种工艺形成,例如熔喷工艺、纺粘工艺、纺丝成网工艺、气流成网工艺、湿法成网工艺、热结合工艺、结合梳理纤网工艺及其组合。非织造材料的例子包括但不限于来自Libeltex BVBA和HRM的共聚酯或来自Essentra的基质中的聚烯烃纤维。
在一些实施例中,负压分布层370可以由聚合物——例如,热塑性弹性体(TPE)、硅树脂或泡沫——形成。TPE的示例包括但不限于苯乙烯-乙烯-丁烯-苯乙烯(SEBS)共聚物或热塑性聚氨酯(TPU)。负压分布层370可以通过组合厚度在约0.2mm与约2.0mm之间的TPE或TPU片材来形成。在一些实施例中,TPE或TPU片材可以彼此结合、焊接、粘合或以其它方式互相联接。例如,在一些实施例中,TPE或TPU片材可以使用辐射热、射频焊接或激光焊接进行焊接。Supracor,Inc.、Hexacor,Ltd.、Hexcel Corp.和Econocorp,Inc.可以生产用于形成负压分布层370的合适的TPE或TPU片材。在一些实施例中,负压分布层370可以由也称为间隔织物的3D纺织品形成。合适的3D纺织品可由Heathcoat Fabrics,Ltd.、Baltex和MuellerTextil Group生产。
在一些实施例中,负压分布层370可以由泡沫形成。例如,多孔泡沫、开孔泡沫、网状泡沫或多孔组织集合体可用于形成负压分布层370。在一些实施例中,负压分布层370可由灰色泡沫或Zotefoam形成。灰色泡沫可以是具有约60孔隙/英寸(ppi)的聚酯聚氨酯泡沫。Zotefoam可以是闭孔的交联聚烯烃泡沫。在一些非限制性示例中,负压分布层370可以包括网状聚氨酯泡沫或基本上由网状聚氨酯泡沫组成,例如在均可从德克萨斯州圣安东尼奥的Kinetic Concepts,Inc.获得的GRANUFOAMTM敷料或V.A.C.VERAFLOTM敷料中发现的网状聚氨酯泡沫。
在一些实施例中,负压分布层370可以包括或基本上由泡沫组成,该泡沫被机械或化学地压缩以增加泡沫在环境压力下的密度。机械或化学地压缩的泡沫可被称为压缩泡沫或毡制泡沫。压缩泡沫的特征可以是硬度系数(firmness factor),其可以定义为压缩状态下的泡沫密度与未压缩状态下相同泡沫的密度之比。例如,硬度系数5可以指压缩泡沫的密度是相同泡沫在未压缩状态下的密度的五倍。与尚未被压缩的相同泡沫相比,机械或化学地压缩泡沫还可以减小泡沫在环境压力下的厚度。通过机械或化学压缩来减小泡沫的厚度可以增加泡沫的密度,从而可以增大泡沫的硬度系数。增大泡沫的硬度系数可以增加泡沫在平行于泡沫厚度方向上的刚度。例如,增大负压分布层370的硬度系数可以增加负压分布层370在平行于该层的厚度的方向上的刚度。在一些实施例中,负压分布层370在其未压缩状态下可具有约0.03克每立方厘米(g/cm3)的密度。在其压缩状态下,负压分布层370可以具有约5的硬度系数(FF),并且密度可以是约0.15g/cm3。
一般而言,如果压缩泡沫受到负压,则压缩泡沫比类似的未压缩泡沫表现出更小的变形或压缩形变。如果负压分布层370由压缩泡沫形成,则相比于负压分布层370由相当的未压缩泡沫形成的情况而言,负压分布层370的厚度可较少地变形。变形的减少可能是由硬度系数所反映的刚度增加引起的。如果经受负压应力,则由压缩泡沫形成的负压分布层370可能比由未压缩泡沫形成的负压分布层370更平整。因此,当对负压分布层370施加负压时,负压分布层370在平行于负压分布层370厚度的方向上的刚度可允许负压分布层370在其它方向——例如,平行于伤口表面的方向——上更加柔顺或可压缩。泡沫材料的孔径可以根据负压分布层370的需要和泡沫的压缩量而变化。例如,在一些实施例中,未压缩的泡沫可具有在约400微米至约600微米范围内的孔径。如果相同的泡沫被压缩,则孔径可能小于泡沫处于未压缩状态时的孔径。
在一些实施例中,负压分布层370可以经由注塑或挤出技术由聚合物形成。
在一些实施例中,负压分布层370可以是单层,例如如图7和8所示。或者,负压分布层370可以是多层的。例如,负压分布层370可以包括两层或更多层、三层或更多层、四层或更多层等。
用于真空伤口疗法的敷料
在本公开的另一方面,在前述实施例中描述的敷料包含连接器,该连接器用于实现通过各层的流体连通。在一个实施例中,连接器联接到覆盖层,使得连接器允许与覆盖层下方的密封空间流体连通。连接器被固定在覆盖层中的孔洞上。连接器可连接到用于产生真空的设备(例如真空泵),以便在覆盖层下方产生减压。
在一些实施例中,连接器可以由半刚性材料如聚氨酯膜或聚氯乙烯构成。刚性或半刚性材料的非限制性示例包括硅树脂、丙烯酸树脂、氰基丙烯酸酯、橡胶、泡沫、纤维素、聚氨酯、聚乙烯、聚氯乙烯、乙烯醋酸乙烯酯、聚丙烯、聚四氟乙烯和聚异丁烯。在一些实施例中,连接器可包含另外的纺织材料层以便减慢或调节渗液的排出。在一些实施例中,连接器可以任选地包含更换盘指示器以在需要更换敷料时提醒使用者。
在另一些实施例中,本文公开的敷料可以被配置用于例如使用柔性管连接到真空泵或其它负压源。这样,提供了从伤口通过设置在敷料中的一层或多层吸收材料到负压源的流体连通路径。该流体连通路径可以通过覆盖层中的孔洞延伸到管的管腔,任选地经由柔性连接器的内腔或导管。典型的柔性连接器是长形的,具有平行于柔性连接器的纵向轴线延伸的内腔或导管,其中柔性连接器可在使得柔性连接器的纵向轴线大致平行于覆盖层的平面的取向上附接到敷料的覆盖层中的开口。柔性构件可以包括用于经由粘合剂或其它方式固定到覆盖层上的头部部分。通常,流体连通路径从柔性连接器的内腔或导管沿大致垂直于柔性连接器的纵向轴线的方向延伸穿过覆盖层中的开口。一旦固定,就可在柔性连接器与覆盖层之间形成不透流体的密封。
在使用中,本文所述实施例的敷料可以固定到伤口周围的皮肤和导管上,该导管构造成用于通过位于导管远端处的连接器连接到负压源。通过经用于将流体从伤口通过吸收层、覆盖层中的孔洞引导到导管的远端的路径施加负压来对伤口施加负压。可能存在于吸收层中的任选的开窗有助于吸收渗液和施加负压。
用于真空伤口疗法的装置
在本公开的另一方面,根据本文公开的任何实施例的敷料可包括固定敷料并与限定在敷料的覆盖层中的孔洞流体连通的移动真空泵。在一些实施例中,敷料包括“机载”真空系统,该真空系统包括足够小以便直接附接到敷料上的泵。这种构型使得能够制造和使用一次性的敷料-泵组合。
虽然已经描述了多个离散的实施例,但是每个实施例的方面可能不只特定于该实施例,并且具体设想实施例的特征可以与另一些实施例的特征相结合。如从本文的描述和相关附图中将了解的,本公开设想了多种方面和实施例,其示例包括但不限于以下列出的方面和实施例:
一种整体式负压伤口敷料结构,其包括:(i)吸收层,所述吸收层具有用于接触伤口的第一表面和与所述第一表面相对的第二表面,所述吸收层包括胶凝吸收材料,其中所述吸收层具有周边边界,(ii)覆盖层,所述覆盖层具有面向所述吸收层的第一表面和与所述覆盖层的第一表面相对的第二表面,其中所述覆盖层的周边边界的尺寸大于所述吸收层的周边边界的尺寸,使得所述覆盖层的周边边界延伸超出所述吸收层的周边边界,和(iii)周边粘性皮肤接触层,所述周边粘性皮肤接触层邻近所述吸收层的周边边界附接到所述吸收层的第一表面上,其中所述周边粘性皮肤接触层限定一窗口,所述吸收层能够通过所述窗口接触伤口,并且其中所述周边粘性皮肤接触层包括水胶体粘合剂,其中,所述周边粘性皮肤接触层的周边边界的尺寸大于所述吸收层的周边边界的尺寸,使得所述周边粘性皮肤接触层的周边边界延伸超出所述吸收层的周边边界,其中,所述覆盖层的周边边界和所述周边皮肤接触层的周边边界结合在一起以形成密封部,其中,所述周边粘性皮肤接触层能操作成粘附到伤口周围的皮肤上,并且其中,所述覆盖层限定了构造成用于连接到负压源的孔洞。
根据本文公开的任何其它实施例的敷料,其中,所述吸收层的周边边界的尺寸大于将由所述敷料覆盖的伤口的尺寸。
根据本文公开的任何其它实施例的敷料,其中,所述覆盖层是不透水但能透空气和蒸气的。
根据本文公开的任何其它实施例的敷料,其中,所述周边粘性皮肤接触层和所述覆盖层能操作成在敷料被施用在伤口上方并且负压源被密封地连接到所述孔洞时在所述吸收层与所述敷料的外部环境之间形成气密密封。
根据本文公开的任何其它实施例的敷料,其中,所述周边粘性皮肤接触层具有约0.1mm至约5mm的厚度。
根据本文公开的任何其它实施例的敷料,其中,所述周边粘性皮肤接触层具有约2cm至约6cm的宽度。
根据本文公开的任何其它实施例的敷料,还包括定位在所述吸收层与所述覆盖层之间的第一结合层。
根据本文公开的任何其它实施例的敷料,其中,所述第一结合层包括水胶体粘合剂层。
根据本文公开的任何其它实施例的敷料,其中,所述第一结合层具有约0.2mm至约2mm的厚度。
根据本文公开的任何其它实施例的敷料,还包括:结构层,所述结构层与所述周边粘性皮肤接触层对应并且具有与所述周边粘性皮肤接触层结合的第一表面;和第二结合层,所述第二结合层与所述周边粘性皮肤接触层对应并且定位成与所述结构层的第二表面接触,所述结构层的第二表面与所述结构层的第一表面相对,其中,所述结构层定位在所述周边粘性皮肤接触层和所述第二结合层之间并且与所述周边粘性皮肤接触层和所述第二结合层密封地结合,并且其中,所述第二结合层与所述吸收层的第一表面的与所述吸收层的整个周边边界相邻的连续部分密封地结合。
根据本文公开的任何其它实施例的敷料,其中,所述周边粘性皮肤接触层、所述第二结合层和所述覆盖层能操作成在敷料被施用在伤口上方并且负压源被密封地连接到所述孔洞时在所述吸收层与所述敷料的外部环境之间形成气密密封。
根据本文公开的任何其它实施例的敷料,其中,所述结构层包括聚氨酯膜。
根据本文公开的任何其它实施例的敷料,其中,所述第二结合层具有约0.2mm至约2mm的厚度。
根据本文公开的任何其它实施例的敷料,还包括:定位在所述吸收层与所述覆盖层之间的第一结合层;结构层,所述结构层与所述周边粘性皮肤接触层对应并且具有与所述粘性皮肤接触层结合的第一表面;和第二结合层,所述第二结合层与所述周边粘性皮肤接触层对应并且定位成与所述结构层的第二表面接触,所述结构层的第二表面与所述结构层的第一表面相对,其中,所述结构层定位在所述周边粘性皮肤接触层与所述第二结合层之间并与所述周边粘性皮肤接触层和所述第二结合层密封地结合,并且其中,所述第二结合层与所述吸收层的第一表面的与所述吸收层的整个周边边界相邻的连续部分密封地结合。
根据本文公开的任何其它实施例的敷料,其中,所述胶凝吸收材料包括凝胶形成纤维或细丝。
根据本文公开的任何其它实施例的敷料,其中,所述凝胶形成纤维或细丝包含化学改性的纤维素、藻酸盐、羧甲基纤维素或其组合。
根据本文公开的任何其它实施例的敷料,其中,所述吸收层包括线迹。
根据本文公开的任何其它实施例的敷料,其中,所述吸收层还包含抗微生物剂。
根据本文公开的任何其它实施例的敷料,其中,所述覆盖层包括选自由聚氨酯(PU)、聚氯乙烯(PVC)、聚硅氧烷弹性体、含氟聚合物和其组合组成的群组的成员。
根据本文公开的任何其它实施例的敷料,还包括密封地连接到所述孔洞并且与所述吸收层流体连通的负压源。
根据本文公开的任何其它实施例的敷料,其中,所述负压源包括使用导管连接到所述孔洞的泵。
根据本文公开的任何其它实施例的敷料,还包括定位在所述吸收层与所述覆盖层之间的负压分布层。
根据本文公开的任何其它实施例的敷料,其中,所述负压分布层包括开孔泡沫层。
根据本文公开的任何其它实施例的敷料,其中,所述开孔泡沫层是疏水的。
根据本文公开的任何其它实施例的敷料,还包括连接器,所述连接器在所述孔洞上方附接到所述覆盖层并且构造成用于连接到导管以将负压从导管通过所述孔洞传输到伤口。
根据本文公开的任何其它实施例的敷料,其中,所述连接器包含聚氨酯或聚氯乙烯。
根据本文公开的任何其它实施例的敷料,其中,所述连接器包括更换指示器。
一种一次性的负压伤口治疗装置,其包括:(i)用于产生负压的一次性泵,和(ii)根据本文公开的任何敷料实施例的用于覆盖和保护伤口的敷料,其中,所述覆盖层限定连接到所述泵的孔洞。
根据本文公开的任何其它实施例的装置,还包括:(iii)限定管腔的导管,所述管腔提供所述泵与限定在所述敷料的覆盖层中的孔洞之间的流体连通,由此当通过将所述周边粘性皮肤接触层加压密封到伤口周围的皮肤上以将所述敷料固定在伤口上方时,所述泵的运行在伤口部位处产生负压。
尽管文中已经示出和描述了本公开的实施例,但是本领域技术人员应当理解,此类实施例仅通过示例的方式提供。本领域技术人员现在将想到许多变型、改型和替换而不脱离本发明。应当理解,在实施本发明时可以采用对本文描述的本发明实施例的各种替代方案。以下权利要求旨在限定本发明的范围,并且这些权利要求及其等同物范围内的方法和结构由此被涵盖。
Claims (29)
1.一种整体式负压伤口敷料结构,其包括:
吸收层,所述吸收层具有用于接触伤口的第一表面和与所述第一表面相对的第二表面,所述吸收层包括胶凝吸收材料,其中所述吸收层具有周边边界;
覆盖层,所述覆盖层具有面向所述吸收层的第一表面和与所述覆盖层的第一表面相对的第二表面,其中所述覆盖层的周边边界的尺寸大于所述吸收层的周边边界的尺寸,使得所述覆盖层的周边边界延伸超出所述吸收层的周边边界;和
周边粘性皮肤接触层,所述周边粘性皮肤接触层邻近所述吸收层的周边边界附接到所述吸收层的第一表面上,其中所述周边粘性皮肤接触层限定一窗口,所述吸收层能够通过所述窗口接触伤口,并且其中所述周边粘性皮肤接触层包括水胶体粘合剂,
其中,所述周边粘性皮肤接触层的周边边界的尺寸大于所述吸收层的周边边界的尺寸,使得所述周边粘性皮肤接触层的周边边界延伸超出所述吸收层的周边边界,
其中,所述覆盖层的周边边界和所述周边皮肤接触层的周边边界结合在一起以形成密封部,
其中,所述周边粘性皮肤接触层能操作成粘附到伤口周围的皮肤上,并且
其中,所述覆盖层限定了构造成用于连接到负压源的孔洞。
2.根据权利要求1所述的敷料,其中,所述吸收层的周边边界的尺寸大于将由所述敷料覆盖的伤口的尺寸。
3.根据权利要求1所述的敷料,其中,所述覆盖层是不透水但能透空气和蒸气的。
4.根据权利要求1所述的敷料,其中,所述周边粘性皮肤接触层和所述覆盖层能操作成在敷料被施用在伤口上方并且负压源被密封地连接到所述孔洞时在所述吸收层与所述敷料的外部环境之间形成气密密封。
5.根据权利要求1所述的敷料,其中,所述周边粘性皮肤接触层具有约0.1mm至约5mm的厚度。
6.根据权利要求1所述的敷料,其中,所述周边粘性皮肤接触层具有约2cm至约6cm的宽度。
7.根据权利要求1所述的敷料,其还包括定位在所述吸收层与所述覆盖层之间的第一结合层。
8.根据权利要求7所述的敷料,其中,所述第一结合层包括水胶体粘合剂层。
9.根据权利要求7所述的敷料,其中,所述第一结合层具有约0.2mm至约2mm的厚度。
10.根据权利要求1所述的敷料,其还包括:
结构层,所述结构层与所述周边粘性皮肤接触层对应并且具有与所述周边粘性皮肤接触层结合的第一表面;和
第二结合层,所述第二结合层与所述周边粘性皮肤接触层对应并且定位成与所述结构层的第二表面接触,所述结构层的第二表面与所述结构层的第一表面相对,
其中,所述结构层定位在所述周边粘性皮肤接触层和所述第二结合层之间并且与所述周边粘性皮肤接触层和所述第二结合层密封地结合,并且
其中,所述第二结合层与所述吸收层的第一表面的与所述吸收层的整个周边边界相邻的连续部分密封地结合。
11.根据权利要求10所述的敷料,其中,所述周边粘性皮肤接触层、所述第二结合层和所述覆盖层能操作成在敷料被施用在伤口上方并且负压源被密封地连接到所述孔洞时在所述吸收层与所述敷料的外部环境之间形成气密密封。
12.根据权利要求10所述的敷料,其中,所述结构层包括聚氨酯膜。
13.根据权利要求10所述的敷料,其中,所述第二结合层具有约0.2mm至约2mm的厚度。
14.根据权利要求1所述的敷料,其还包括:
定位在所述吸收层与所述覆盖层之间的第一结合层;
结构层,所述结构层与所述周边粘性皮肤接触层对应并且具有与所述粘性皮肤接触层结合的第一表面;和
第二结合层,所述第二结合层与所述周边粘性皮肤接触层对应并且定位成与所述结构层的第二表面接触,所述结构层的第二表面与所述结构层的第一表面相对,
其中,所述结构层定位在所述周边粘性皮肤接触层与所述第二结合层之间并与所述周边粘性皮肤接触层和所述第二结合层密封地结合,并且
其中,所述第二结合层与所述吸收层的第一表面的与所述吸收层的整个周边边界相邻的连续部分密封地结合。
15.根据权利要求1所述的敷料,其中,所述胶凝吸收材料包括凝胶形成纤维或细丝。
16.根据权利要求15所述的敷料,其中,所述凝胶形成纤维或细丝包含化学改性的纤维素、藻酸盐、羧甲基纤维素、或其组合。
17.根据权利要求15所述的敷料,其中,所述吸收层包括线迹。
18.根据权利要求1所述的敷料,其中,所述吸收层还包含抗微生物剂。
19.根据权利要求1所述的敷料,其中,所述覆盖层包括选自由聚氨酯(PU)、聚氯乙烯(PVC)、聚硅氧烷弹性体、含氟聚合物、及其组合组成的群组的成员。
20.根据权利要求1所述的敷料,其还包括密封地连接到所述孔洞并且与所述吸收层流体连通的负压源。
21.根据权利要求20所述的敷料,其中,所述负压源包括使用导管连接到所述孔洞的泵。
22.根据权利要求1所述的敷料,其还包括定位在所述吸收层与所述覆盖层之间的负压分布层。
23.根据权利要求22所述的敷料,其中,所述负压分布层包括开孔泡沫层。
24.根据权利要求23所述的敷料,其中,所述开孔泡沫层是疏水的。
25.根据权利要求1所述的敷料,其还包括连接器,所述连接器在所述孔洞上方附接到所述覆盖层并且构造成用于连接到导管以将负压从导管通过所述孔洞传输到伤口。
26.根据权利要求25所述的敷料,其中,所述连接器包含聚氨酯或聚氯乙烯。
27.根据权利要求25所述的敷料,其中,所述连接器包括更换指示器。
28.一种一次性的负压伤口治疗装置,其包括:
用于产生负压的一次性泵;和
用于覆盖和保护伤口的敷料,所述敷料包括:
吸收层,所述吸收层具有用于接触伤口的第一表面和与所述第一表面相对的第二表面,所述吸收层包括胶凝吸收材料,其中所述吸收层的周边边界的尺寸大于将被所述敷料覆盖的伤口的尺寸;
覆盖层,所述覆盖层具有面向所述吸收层的第一表面和与所述覆盖层的第一表面相对的第二表面,其中所述覆盖层是不透水但能透空气的,其中所述覆盖层的周边边界的尺寸至少与所述吸收层的周边边界的尺寸一样大,并且其中所述覆盖层的邻近所述覆盖层的周边边界的部分与所述吸收层的邻近所述吸收层的周边边界的部分结合;和
周边粘性皮肤接触层,所述周边粘性皮肤接触层邻近所述吸收层的周边边界附接到所述吸收层的第一表面上,其中所述周边粘性皮肤接触层限定一窗口,所述吸收层能够通过所述窗口接触伤口,并且其中所述周边粘性皮肤接触层包含水胶体粘合剂,
其中,所述覆盖层限定连接到所述泵的孔洞。
29.根据权利要求28所述的装置,其还包括限定管腔的导管,所述管腔提供所述泵与限定在所述敷料的覆盖层中的孔洞之间的流体连通,由此当通过将所述周边粘性皮肤接触层加压密封到伤口周围的皮肤上以将所述敷料固定在伤口上方时,所述泵的运行在伤口部位处产生负压。
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US20220331168A1 (en) | 2022-10-20 |
CO2022010529A2 (es) | 2022-10-21 |
AU2020411031A1 (en) | 2022-06-16 |
BR112022012669A2 (pt) | 2022-09-06 |
JP2023509605A (ja) | 2023-03-09 |
EP4081173A1 (en) | 2022-11-02 |
US20210196525A1 (en) | 2021-07-01 |
WO2021130475A1 (en) | 2021-07-01 |
US11331221B2 (en) | 2022-05-17 |
CA3165954A1 (en) | 2021-07-01 |
CN114901224B (zh) | 2023-07-14 |
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