CN110013382A - 用于真空疗法的伤口敷料 - Google Patents

用于真空疗法的伤口敷料 Download PDF

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CN110013382A
CN110013382A CN201910103068.5A CN201910103068A CN110013382A CN 110013382 A CN110013382 A CN 110013382A CN 201910103068 A CN201910103068 A CN 201910103068A CN 110013382 A CN110013382 A CN 110013382A
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yarn
wound
fiber
open structure
wound dressing
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W.邦内芬
S.弗雷
A.普伦蒂斯
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Convatec Technologies Inc
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Abstract

本发明公开一种用于真空伤口疗法的伤口敷料，所述伤口敷料包含伤口接触层，所述伤口接触层为包含含有凝胶成型长丝或纤维的纱的疏松结构，所述结构具有允许渗出物流经其的孔隙。

Description

用于真空疗法的伤口敷料
本申请是申请号201280068356.8(PCT/GB2012/052950)，申请日2012年11月29日，发明名称“用于真空疗法的伤口敷料”的中国专利申请的分案申请。
技术领域
本发明涉及一种用敷料和真空治疗伤口的装置和套件。
背景技术
已使用真空来增加到达伤口组织的血流量以及除去来自伤口部位的渗出物。一般而言，真空治疗采用包括用于围绕伤口外周边进行密封的覆盖件的装置，在所述覆盖件下方形成真空以作用于伤口表面。施加至伤口表面的真空加速了慢性伤口的愈合。通常将开孔泡沫材料筛网或纱布用于覆盖件下方以提供真空形成的空间并减少组织向内生长。将足够的真空施加合适的持续时间以促进组织迁移，以便有利于伤口的闭合。合适的真空介于约0.1个大气压与0.99个大气压之间。真空可为基本上连续的或可通过在施加与不施加时段之间交替进行真空施加来循环。
许多常见的常规和先进伤口接触敷料具有各种缺点，特别是对于用于抽吸伤口疗法（suction wound therapy）而言。在一个实例中，纱布和其它类似的平面织物材料通常用作伤口敷料。当纱布与伤口接触时，其被渗出物润湿并且倒塌到伤口中。新组织生长可卷入纱布，从而使得从伤口移除纱布变得困难和疼痛。当泡沫与伤口接触并且施加真空时，泡沫可倒塌并且组织可向内生长到泡沫的倒塌细胞结构中。为了克服此问题，已使用相对刚性的穿孔片材来接触伤口。然而，它们不具有足够的柔性和可适形性以舒适并充分地适形于轮廓往往不规则的伤口表面。具有此类非柔性或刚性结构化材料或伤口接触层的敷料可导致患者经历不必要的疼痛和不适。
在WO 2006/052839中，描述了一种真空伤口敷料，其为被伤口渗出物润湿时形成内聚凝胶的纤维共混物或纤维材料。所述敷料呈非织造纤维垫的形式。
用于真空伤口疗法的伤口敷料优选具有下列特征和性质中的一些或全部：
其是多孔的以允许渗出物流动；
其具有孔或洞以使得下层组织能够感受到组织应变的作用；
其可易于折叠或卷缩（scrunch）以填充伤口部位；
如果是纤维构成的，则其进入伤口中的纤维损失最小；
其对伤口侧所呈现的材料性质与对伤口床(wound bed)所呈现的材料性质相同，使得伤口接触表面在整个伤口上是一致的；
其阻止组织向内生长；
其具有足够的湿强度以有利于容易的移除；
其在吸收渗出物时不对伤口床施加压力；
其适于一定范围的伤口尺寸和各种形状及深度；
其具有最小的生物粘附以使移除时对伤口床的破坏最小化；
其在受到施加的抽吸时对组织施加有益的应变。
发明内容
我们发现可提供一种具有许多上述所需性质的凝胶成型伤口敷料，且其克服了上述组织向内生长问题中的一些同时填充伤口并在施加真空时允许渗出物流出伤口部位。
因此，本发明提供一种用于真空伤口疗法的伤口敷料，所述伤口敷料包含伤口接触层，所述伤口接触层为包含含有凝胶成型长丝或纤维的纱的疏松结构，所述结构具有允许渗出物流经其的孔隙。
已经发现的是，认为通过真空施加在组织上的应力会刺激新的组织生长并且帮助愈合。认为本发明的敷料的疏松结构中存在的孔隙有利于将应力施加至伤口组织。
所述疏松结构可为由包含凝胶成型长丝或纤维的纱针织、机织或刺绣的网的形式。术语纱是指连续长丝或短纤维的丝条（thread）或股线（strand）。或者，所述疏松结构可首先由纺织纱进行针织、机织或刺绣，然后对其进行化学改性以赋予其凝胶成型性质。例如，纱可为纤维素纱，其经针织或机织以形成疏松结构，然后对其进行化学改性以赋予纤维更高的吸收性和胶凝性质。
凝胶成型纤维是指吸湿纤维，其在吸收伤口渗出物时变得湿滑或成凝胶状，从而减小了周围的纤维粘附至伤口的趋势。凝胶成型纤维可为在吸收渗出物时保持其结构完整性的类型或可为失去其纤维形式且变成无结构凝胶的类型。凝胶成型纤维优选地为纺成的羧甲基纤维素钠纤维、化学改性的纤维素纤维、果胶纤维、海藻纤维、脱乙酰壳多糖纤维、透明质酸纤维或其它多糖纤维或源自树胶的纤维。纤维素纤维优选地具有每个葡萄糖单位至少0.05个取代基团的取代度。凝胶成型纤维优选地具有每克纤维至少2克0.9%盐水溶液的吸收性（根据通过主要伤口敷料的自由溶胀吸收性方法(free swell absorbency method)BS EN 13726-1:2002测试方法–第1部分：吸收性方面(Aspects of absorbency)，方法3.2自由溶胀吸收容量测量）。
优选地，凝胶成型纤维具有根据自由溶胀吸收性方法测量的至少10g/g，更优选介于15g/g与25g/g之间的吸收性。
敷料可例如包含非凝胶成型纤维，特别是纺织纤维例如Tencel、棉或粘胶纤维并且可包含lycra或其它弹性纤维。优选地，纺织纤维具有根据自由溶胀方法测量的小于10g/g，更优选小于5g/g的吸收性。
敷料的孔径在部分程度上决定了进行抽吸时施加在伤口上的应力。该应力还决定于敷料在整个处理区域上的均匀度。因此，其应用的最大应力和均匀度将不仅取决于疏松结构的孔径，而且还取决于用于制备敷料的纱的线密度。最大应力可通过增大孔径或增大纱线密度来实现。通过减小孔径和降低纱线密度来增加均匀度。我们已发现如果结构的孔径优选地介于0.5mm2至5.0mm2，更优选地介于3.0mm2至4.0mm2并且纱的线密度为20特至40特，则伤口上施加了可接受的应力。
疏松结构可为其中纱间隔接合形成一组网孔的网的形式或疏松结构可以编制成具有上述孔径。
此类疏松结构的优点是其易于折叠或皱折以贴合伤口并包裹伤口部位。由于所述结构，即使敷料可能未与伤口床共平面，在将真空施加至伤口时敷料仍允许渗出物穿过其。疏松结构的适形性允许伤口的所有部分均与相似的敷料结构接触，从而例如使得伤口的侧面被疏松结构以及伤口床接触。
在另一个实施方案中，本发明提供了一种用于真空伤口疗法的装置，所述装置包括：伤口敷料，其为包含凝胶成型长丝或纤维纱的疏松结构，所述结构具有允许渗出物流经其的孔隙；
真空源，其设置为通过伤口敷料与伤口床分离；和
真空密封层，其覆盖伤口敷料且适于保持伤口接触层中的相对真空。
本发明敷料的疏松结构可通过首先形成胶凝纤维纱来制备。这可以多种方式进行。例如，可将凝胶成型纤维（其为例如上述纤维中的任一种或可为改性纤维素或羧甲基纤维素或海藻纤维）纺成包含凝胶成型短纤维与纺织纤维共混物的纱。纺纱可首先通过梳理共混物中的纤维和然后将经梳理的共混物纺成纱。
我们已发现特别合适的纱可通过气流纺纱或自由端纺纱来形成。在此类方法中，将凝胶成型短纤维与纺织纤维共混并进行梳理以制备连续网。将所述网集丝（condense）以制备粗梳条，然后进行气流纺纱。在气流纺纱中，使用高速离心机来收集各根纤维并将其加捻成纱。通过此技术生产的纱的特性是具有足够的抗拉强度，以使得能够采用针织或机织机械对它们进行进一步处理。
本发明的另一实施方案提供了一种制备包含凝胶成型纤维的纱的方法，其包括以下步骤：
将凝胶成型短纤维任选地与纺织纤维共混；
梳理形成连续网；
拉伸该网以制备丝条；和
气流纺纱以制备纱。
通过此方法制备的纱优选地包含30%至100%重量的凝胶成型纤维以及0%至70%重量的纺织纤维。更优选地，所述纱包含50%至100%重量的凝胶成型纤维以及余量的纺织纤维，最优选60%至100%重量的凝胶成型纤维。
存在于短纤纱中的纤维优选地具有30至60mm，更优选40至55mm，最优选45至55mm的短纤长度。
根据本发明的方法制备的纱无需含有纺织纤维，这能够产生完全由凝胶成型纤维组成的结构。
可使用由天然纤维素纤维或溶剂纺纤维素短纤维或纤维素纤维与其它纺织纤维的共混物组成的短纤纱或使用溶剂纺纤维素的长丝纱，然后进行转化以对纱进行化学修饰，产生胶凝性质，从而制备胶凝纱。例如，Lyocell纱可用作起始物料并可在煮炼工艺中转化以赋予纱凝胶成型特性。
根据本发明的方法制备的纱的干抗拉强度优选为至少10cN/tex，优选10至40cN/tex，最优选16至35cN/tex，根据英国标准ISO 2062 2009测量。
或者，本发明的敷料的疏松结构可这样形成：通过使用纺织纱进行机织，然后使所得织物进行转化以赋予其凝胶成型特性，从而形成凝胶成型纤维的疏松结构。
还可能使用诸如Lyocell的纺织纱对疏松结构进行经编或纬编，然后转化所得织物以制备本发明的伤口敷料。另外，可能将纺织纱中的疏松结构刺绣到支承膜上，然后例如通过洗涤移除支承膜并且将所得结构进行转化以形成包含凝胶成型纤维纱的疏松结构。
在另一方面，本发明提供了一种通过以下步骤制备疏松结构或凝胶成型纤维网的方法：
将纺织纱中的疏松结构刺绣到可溶性支承膜上；
通过溶解所述支承膜来移除它；和
对所述结构进行转化以赋予纱凝胶成型特性并形成包含凝胶成型纤维纱的结构。
转化纱或织物的优选方法在WO 00/01425中有所描述。例如，可通过在65℃下泵送反应流体通过反应容器并从而使纤维素材料泵送通过反应容器并保持90分钟来使纱或织物羧甲基化。所述反应流体为碱（通常为氢氧化钠）和一氯乙酸钠在工业用变性醇中的溶液。在反应时间后，反应物用酸中和并洗涤，然后在实验室烘箱中在40℃下干燥1小时。
附图说明
本发明的优选实施方案在附图中示出，其中：
图1为示出本发明的纱的抗拉强度的图；
图2示出由包含呈松弛、略微展开且润湿以及略微展开状态的凝胶成型纤维的纱制备的疏松结构；
图3a示出呈干燥和润湿状态的使用Tencel经纱和用本发明的纱进行引纬而针织的织物；
图3b示出图3a中的织物的纱的彼此闭口；
图4示出通过在膜上刺绣纺织纱制备的疏松结构；(a)示出在膜上刺绣的双层结构，(b)示出转化的干燥结构和(c)示出结构被润湿；
图5示出使用HF-2011/250制备的经纱针织结构中的闭口；
图6示出图5的显微图像，其示出在编链组织（pillar stitch）内形成毛圈的连接纱；
图7示出呈干燥状态的转化的机织结构；
图8示出来自图7但润湿的结构。
具体实施方式
通过以下实施例对本发明进行阐述。
实施例1–由凝胶成型短纤维纺纱
通过在Trutzschler梳棉机上进行梳理并对所得丝条以650转/米的捻度进行纺纱来制备Lyocell纤维和羧甲基纤维素短纤维的50:50、60:40和70:30 CMC：Lyocell纤维共混物。
实施例2–将纺织纱转化成凝胶成型纱
在实验室中使用小型煮布锅对纱进行转化。在两次试验中，对短纤和长丝Lyocell纱进行转化。用于转化的纱为短纤33 Tex Tencel®；HF-2011/090；和20特长丝Lyocell组HF-2011/051（试验1）和HF-2011/125（试验2）。Tencel®是Lenzing拥有的Lyocell商标品牌并且所用Tencel®纱为短纤纺纱。长丝Lyocell由聚隆化学品和纤维公司（Acelon chemicalsand Fiber Corporation，台湾）通过Offtree有限公司供应。
对纱进行转化的优点是全部筒纱可以一种相对简单的方法转化并且避免了对胶凝纤维的处理，从而减少了所需的处理步骤数以及对纤维的损坏。
试验1–围绕煮布锅芯卷绕的纱
在此试验中，使用电钻使煮布锅的穿孔芯旋转并以一定的速度从卷装中拉引Tencel®纱，从而使纱围绕所述芯紧密卷绕。这意味着纱在张力下围绕芯紧密卷绕。
通过WO 00/01425中描述的方法对纱进行转化，在所述方法中，通过在65℃下将流体泵送通过煮布锅并从而使纤维素材料泵送通过煮布锅并持续90分钟来进行羧甲基化。所述反应流体为碱（通常为氢氧化钠）和一氯乙酸钠在工业用变性醇中的溶液。在反应时间后，反应物用酸中和并洗涤，然后在实验室烘箱中在40℃下干燥1小时。
转化成功进行并且产生短纤和长丝胶凝纱；分别为HF-2011/103和HF-2011/105。由于短纤纱围绕芯的紧密和不平卷绕，必须使用小刀将短纤纱移除，留下多个短长度（大约14cm）的转化纱。
试验2–小绞纱（Yarn Hanks）
第二试验的目的是制备长度较长的转化纱以供测试，因此由短纤和长丝Lyocell纱手动制备小绞纱并且将其置于织物层之间以用于转化。
通过将绞纱置于煮布锅中并按照上文针对试验1所述进行转化以形成凝胶成型纤维纱，从而对纱进行转化。
转化成功进行并且产生短纤和长丝胶凝纱；分别为HF-2011/146和HF-2011/147。
纱汇总
样品 HF#
胶凝纱 50:50纺成短胶凝纱 HF-2011/001
60:40纺成短胶凝纱 HF-2011/088
70:30纺成短胶凝纱 HF-2011/108
转化的短纤纱（试验1） HF-2011/103
转化的长丝纱（试验1） HF-2011/105
转化的短纤纱（试验2） HF-2011/146
转化的长丝纱（试验2） HF-2011/147
非胶凝纱 短Tencel® HF-2011/090
长丝Lyocell（样品） HF-2011/051
长丝Lyocell（膨体） HF-2011/125
得自实施例1和2的结果
除了HF-2011/051之外，对所有纱的湿抗拉强度和干抗拉强度进行测试。对标准方法BSEN ISO 2062:2009；“纺织品-卷装纱：利用恒速伸长(CRE)试验仪进行单根纱线断裂强力和断裂伸长率的测定”进行调整。使用标距为100mm的Zwick拉伸试验机。试验采用100N或20N载荷传感器对纱施加恒速伸长直至达到断裂点。通过在每根纱的中央3至4cm内用0.2ml的溶液A润湿样品并保持1分钟来测量湿拉伸试验。然后将润湿样品放置在Zwick的夹具中并夹紧闭合。当所制备的纱强固到足以抵抗张力和在针织、梭织和刺绣期间施加的力时测试抗拉强度。
抗拉强度
结果表明所有的纱在干燥时比润湿时更强固，其中HF-2011/108（70:30胶凝纱）表现出最大比例的强度下降。
在所测试的纱中，HF-2011/108尽管含有30%Lyocell纤维，但仍为在润湿和干燥时强度最弱的纱，其中润湿和干燥时的抗拉强度分别为12.4N/Tex和3.4cN/Tex。虽然其为强度最弱的纱，但成功地将HF-2011/120纬编成织物和将HF-2011/169机织成织物，据信其它所有的纱也足够强固到转化成织物。
两种方法均成功制备得到胶凝纱。
实施例3 由凝胶成型纱制备疏松结构
制备具有2/12s精纺纱支数的纱，其由60% CMC纤维和40%粘胶纤维组成，各纤维的短纤长度为~40mm并将这些纤维在纤维阶段混合。使用精纺系统制备纱并将两个12支股线合股在一起。在干燥时，该纱手感柔软并且合股随着两个股线围绕彼此卷绕而明显。在用溶液A润湿时，纱胶凝化且溶胀形成较厚的纱，并且合股变得更加明显。
使用此纱在经编机/缝编机上制备样品并将样品用溶液A水合。
将Tencel经纱和胶凝纱纬纱以网状排列方式进行针织而得到样品结构，所述网状排列方式尤其在通过轻缓伸展使所述结构疏松时可见，如图2所示。在润湿时，所述结构轻度胶凝化且具有润湿感，但其仍良好保持疏松形状。
实施例4
通过实施例3的方法制备包含凝胶成型纤维的纱。使用此纱，通过织物Tencel经纱和胶凝纱引纬来针织织物。纬纱的引入方式应使得其由于针织图案而变得闭口。该材料的纬纱通道符号标志为0-1/1-1/1-2/2-3/3-2/2-1/1-2//。该材料的手感非常薄并且在润湿时胶凝化，但似乎将流体保持在其表面上。
实施例5 由纺织纱制备疏松结构
使用Tajima TMEX-C1201刺绣机，在PVA膜上由Lyocell丝线（在筒管上且作为顶线）制备织物。
丝线 = 来自Tony Slade (T.S. Sewing Supplies)的Gütermann 120特Lyocell丝线
软件 = Wilcom ES
程序名 = honeycomb（蜂窝状）
针数 = 每2层12,369针
衬膜 = 可溶性PVA膜
所用速度 = 1200rpm
膜通过如下方式移除：在水槽中用温热自来水通过多次搅拌进行洗涤，直至膜看起来已被移除。使样品在工作台上风干。通过WO 00/01425中所述以及实施例2中详述的方法对织物进行转化。
实施例6
经编以制备闭口结构。
为了制备完全闭口（locked in）的结构，优选无任何衬纬的经编织物。在以下实施例（图5）中，已由一组织物4个编链组织形成织物，然后使纱与相邻组的编链组织搭接并继续在此针上形成编链组织，然后搭接回初始针。例如，最简单类型的此织物的典型纱通道符号标志为0-2/2-1/2-1/2-0/0-1/0-1//。通过在一组链状线圈内使用2组经纱，使得用于每个线圈的纱进行交替，从而可防止结构被容易地解开。可通过在设计内使用更多的针或使用添加经轴以沿相反的方向搭接来使该结构复杂化。当每个针织线圈被另一纱端的针织线圈固定从而防止结构解开时，所制备的织物为闭口结构，与编链组织垂直的丝线还形成结构内的毛圈，如图6中所示，从而确保这些是闭口的。
实施例7 机织
在Northrop织机上，使用此前描述的胶凝纱HF-2011/108制备织物HF-2011/169，从而制得疏松平纹结构。并且通过使用Tencel短纤纱HF-2011/090并在织物阶段进行转化来制备织物HF-2011/136。所述结构的经密度为7.8根经纱/厘米，纬密度为5.5根纬纱/厘米。
图7示出HF-2011/136，其为使用此前所述的实验室转化方法在织物阶段转化的样品。这制备得到呈干燥形式时为薄和柔性的疏松结构。当润湿时，此结构不太稳定并且会打褶，但会形成如图8中所示的胶凝结构。
实施例8
使用纱罗织造(leno weaving)来制备闭口机织样品。纱罗织造为一种机织形式，其中使经纱线在纬纱之间彼此交叉。由于经纱彼此交叉，它们能够将纬纱固定到位，因此在结构内很少发生移动。当切割样品时，理论上，纱应当不能被移除，因为自由端被结构其余部分内的多根经纱固定到位。可对织物内的所有或一些纱应用纱罗织法。

Claims (11)

1.一种用于真空伤口疗法的伤口敷料，所述伤口敷料包含伤口接触层，所述伤口接触层为包含含有化学改性凝胶成型长丝或纤维的纱的疏松结构，所述疏松结构的孔径或网目尺寸介于0.5mm2和5.0mm2之间，允许渗出物流过所述疏松结构；其中所述纱的线密度为20特至40特，并且所述疏松结构的纱包含50%至100%的凝胶成型长丝或纤维。
2.如权利要求1所述的伤口敷料，其中所述疏松结构的孔径或网目尺寸介于3.0mm2至4.0mm2之间。
3.如权利要求1或2所述的伤口敷料，其中所述疏松结构被针织。
4.如权利要求1或2所述的伤口敷料，其中所述敷料呈网的形式，所述网的纱间隔接合以形成一组网孔。
5.一种用于真空伤口疗法的装置，其包括：
权利要求1的伤口敷料；
真空源，其设置为通过所述伤口敷料与伤口床层分离；和
真空密封层，其覆盖所述伤口敷料且适于保持所述伤口接触层中的相对真空。
6.一种制备包含如权利要求1所述的化学改性凝胶成型长丝或纤维的纱的疏松结构的方法，其包括以下步骤：
(i)将纺织纱中的孔径或网目尺寸介于0.5mm2至5.0mm2之间的疏松结构刺绣到可溶性支承膜上；
(ii)通过溶解所述支承膜来移除其；和
(iii)对步骤(i)所述结构进行化学改性以赋予所述纱凝胶成型性质，从而形成包含凝胶成型长丝或纤维的纱的该疏松结构，其中允许渗出物流过所述疏松结构的孔或网孔。
7.如权利要求6所述的方法，其中所述化学改性为使用碱与一氯乙酸钠在工业用变性酒精中的溶液的反应流体所进行的羧甲基化。
8.权利要求7所述的方法，其中所述纱的抗拉强度为至少10cN/tex。
9.如权利要求1所述的伤口敷料，其中所述化学改性凝胶成型长丝或纤维通过羧甲基化进行化学改性。
10.如权利要求1所述的伤口敷料，其中所述化学改性凝胶成型长丝或纤维包括化学改性纤维素或海藻酸盐。
11.如权利要求6所述的方法，其中所述纺织纱包括选自Tencel、棉、粘胶纤维、lycra和其它弹性纤维的纤维。
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