CN110475530A - 伤口处理***以及使用和组装的方法 - Google Patents
伤口处理***以及使用和组装的方法 Download PDFInfo
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- CN110475530A CN110475530A CN201780073476.XA CN201780073476A CN110475530A CN 110475530 A CN110475530 A CN 110475530A CN 201780073476 A CN201780073476 A CN 201780073476A CN 110475530 A CN110475530 A CN 110475530A
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Abstract
提供了伤口处理制品、***和药盒,以及组装和处理的方法,其中纳米多孔均孔膜是病原体调节的,与有回弹力的、柔性或弹性支持物组合以提供用于医疗行业的定制伤口处理绷带和/或药盒。
Description
发明领域
无菌制品,其使空气能够接触伤口,与此同时调节伤口中的水分并提供病原体抗性,并且任选地作为传感器用于监测和检测目的分析物。
背景技术
在卫生保健行业,卫生保健提供者面临的最大问题之一是他们解决慢性或严重伤口的能力,这些伤口通常需要数月才能愈合。目前,现有技术的绷带是水胶体技术,其是基于纤维素的黏合剂,其作为合成痂(synthetic scab)发挥作用。水胶体绷带的问题在于其是用闭合性聚氨酯背衬制成的,这会引起浸渍(由于伤口部位周围过多的水分而导致的组织溶解)。因此,卫生保健提供者需要经常更换绷带以防止浸渍,但频繁更换敷料提高感染风险,并可干扰身体的自然伤口愈合过程。
治疗严重伤口的另一种方法是使用多层纱布和医用胶带。纱布促进了透气性,但随着时间的推移,它们会很快被流体饱和,并且不对纳米级的病原体产生抗性。因此,卫生保健提供者也必须定期更换纱布敷料(通常每8小时)。
仍然需要提供定制的无菌绷带,其有助于空气输送至伤口,并同时调节伤口中的水分以避免或消除浸渍(水溶解伤口部位周围的组织),用于更不频繁的绷带更换和加速的愈合。仍然还需要提供广谱细菌和病原体抗性而不使用可促进抗生素抗性菌株生长的抗菌涂层。
附图简述
图1举例说明了本发明的多层复合绷带(multilayer composite bandage);
图2是示出本发明的高度均匀的孔径(pore size)分布的纳米多孔嵌段共聚物膜的扫描电子显微镜(SEM)图像。
图3举例说明了本发明的另一个实施方案,其包含具有可调孔径的两种不同的膜。
发明详述
一些实施方案涉及包含至少一种均孔(isoporous)自组装纳米多孔膜和支持物的制品,其中所述膜和/或支持物是生物相容性的。定制的制品包含外部绷带、人工皮肤移植物、用于疝的内部绷带、以及细胞支架。
如图1和3中所示,制品1(复合材料或绷带)包含膜2、调节孔3和支持物4。图3示出了添加具有与孔3不同尺寸的调节孔6的第二膜5。图2是膜2表面的表面SEM图像。
更具体地,本发明提供了绷带和药盒(kit),其包含具有1至60、100、200nm的调节孔径的均孔自组装纳米多孔膜,以及至少一层柔性、有回弹力的(resilient)和/或弹性支持物层,其还可以是生物相容性的。支持物和膜层中的至少一种可包含使对伤口的附着最小化或降低的药剂,并且可通过涂覆、喷涂或直接将药剂与均孔膜和支持物层中的至少一种合并来提供。在本发明的上下文中,均孔意指具有基本上窄的孔直径分布。
本发明的膜可以是生物相容的,用于与皮肤/伤口接触或内部使用,可由使其可生物降解以供临时使用的聚合物组分(即合成痂)形成,可包含用于对伤口进行灭菌的抗细菌/微生物剂,可包含用于相对于伤口部位释放(release)的非黏性剂(non-stick agent),可包含用于附着至外部或内部组织的静摩擦剂(stiction agent)或涂层,可包含试剂并提供适于增强细胞生长的孔径,并且可包含药物洗脱小分子和/或生物制剂(biologics)。
本发明的膜的另外的功能可包括生物相容性、抗细菌/微生物活性、伤口释放、药物洗脱、细胞生长增强,并且可通过以下来提供:薄膜涂层(例如,浸涂、喷涂、气相沉积)、表面改性(例如,共价改性、“接枝到”和“从……接枝”二者、静电吸引(例如逐层、小分子静电附着)、改变膜聚合物化学、气体簇离子束(gas cluster ion beam)表面改性和孔径可调性。
当组合多于一个自组装纳米多孔膜时,每个膜层可各自具有1至60nm的孔径,或者离散的层可具有特定的孔或不同的孔径范围(例如,1至30nm、10至40nm、20至50nm、20至40nm、20至60nm)。可组合具有不同尺寸孔范围/尺寸的层以获得另外的功能。
在本发明中,复合绷带***可具有织物,其具有多层,每层提供特定性质。在最低限度,织物必须包含定制的纳米多孔聚合物膜(提供了大于约960g/m2至小于3200g/m2的透气性、水分调节和病原体抗性),以及提供机械/结构性质的多孔背衬材料(例如支持物)。绷带***可作为带刻痕(scored)或未刻痕(unscored)的连续卷(continuous roll)提供。绷带织物支持物可以是纵向弹性的并且可在经线或纬线方向上撕裂。或者,绷带***可以以任意维度的离散尺寸提供,例如2×2″、2×4″、4×4″、6×8″。
本发明的绷带***还可作为药盒提供,其中病原体特异性绷带可作为多种预组装绷带提供,用于特定类别的病原体、特定病原体种类和特定的药物治疗剂,其也可被定制用于患者或伤口类型。该药盒包含不同的病原体特异性绷带,例如:至少一个第一绷带,其中均孔自组装纳米多孔膜的孔径为1至60nm;至少一个第二绷带,其具有孔径为1至100nm的均孔自组装纳米多孔膜;以及另外的绷带,其具有均孔自组装纳米多孔膜,所述均孔自组装纳米多孔膜具有至少包括1至200nm孔径的其他孔径。药盒的绷带可提供生物相容性、可生物降解性、抗细菌/微生物、非黏性、细胞生长增强和药物洗脱中的至少一种。
将选择无论是针对广谱病原体设计的,还是针对特定病原体定制的绷带,并将其施加至伤口,使得经调节的纳米多孔膜或支持物层将面向/接触伤口,在这种情况下,用于面向层的材料应该是生物相容性的、非浸出性的,并且能够与开放性伤口直接接触,如图1中所示。生物相容性非黏性剂(例如有机硅树脂),可与膜或支持物组合以允许绷带***的任一侧接触伤口。
纳米多孔聚合物膜层应该对空气具有高度透过性,但对病原体是不透过的。病原体可包括细菌、病毒、原虫或藻类,通常来说,对于大多数病毒,尺寸为0.01至0.1μm,且对于细菌,尺寸为0.1至20μm。细菌是球形(球菌)、棒状(杆菌)或螺旋形(螺旋体),并且也被分类为革兰氏阳性,例如金黄色葡萄球菌(Staphylococcus aureus)、非溶血性链球菌(non-haemolytic streptococci),β-溶血性链球菌(Beta-haemolytic streptococcus);革兰氏阴性,例如大肠杆菌(Escherichia coli)、铜绿假单胞菌(Pseudomonas aeruginosa)、克雷伯菌属物种(Klebsiella species)、变形杆菌属物种(Proteus species)。其他病原体包括厌氧菌,例如拟杆菌属(Bacteroides)和梭菌属(Clostridium);以及真菌,例如白念珠菌(Candida albicans)和曲霉属(Aspergillus)。
通过使用自组装嵌段共聚物,其形成孔径为1至60nm的均孔膜,来实现空气透过性和病原体不透过性,如图2的SEM中所示。孔的高密度使膜具有更高的透过性,而均孔性(isoporosity)作为多种目的病原体的尺寸选择屏障而发挥作用。还可均匀地调节孔径以控制伤口部位上方的水分传输。该膜是具有至少一个氢键合嵌段和疏水嵌段的多嵌段共聚物。合适的氢键合嵌段包括但不限于:聚乙烯吡啶、聚环氧乙烷、聚丙烯酸酯和聚甲基丙烯酸酯,以及经低级烷基取代的聚丙烯酸酯和聚甲基丙烯酸酯。合适的疏水嵌段可包括但不限于:聚苯乙烯类,例如聚苯乙烯和聚(经烷基取代的苯乙烯),例如聚(α-甲基苯乙烯);聚乙烯类、聚丙烯类、聚氯乙烯类和聚四氟乙烯类(其包括膨胀PTFE)。
多孔背衬材料简单地作为纳米多孔聚合物膜的机械基底而发挥作用。其应该具有比聚合物膜大得多的孔径,以便不会产生对于透过性的瓶颈,并且其应该向复合绷带传递机械稳定性和柔性。合适的材料可包含编织(knitted)、织造(woven)或非织造(nonwoven)材料,例如纱布、基于纤维素的织物、棉、人造丝(rayon)、聚酯类、聚乙烯类和开放结构的聚氨酯膜,所有这些材料都足够透气以允许空气容易地流动至和接近伤口部位。
典型的绷带尺寸可匹配现有的标准尺寸(例如4×4″或6×8″),或者可设想为具有一些自黏材料的包裹物。一些替代方案包含用于多种层的多种材料组合物,多种层的厚度,以及膜层中的孔径范围和均孔度的变化。还可将另外的层添加至堆叠以提供另外的功能(例如,生物相容性、药物性质等)。
提供必要保护的参数是使用纳米多孔聚合物膜作为用于伤口护理的绷带材料。孔径可以是几纳米及更大,这对于限定水分控制、传输速率和对多种病原体的排斥是重要的。
单独或与四氢呋喃(THF)、甲醇、乙醇、甲苯、氯仿、二甲基甲酰胺、丙酮和二甲基亚砜组合的溶剂1,4-二氧六环在制备均孔级的多嵌段共聚物膜中用作溶剂,并产生薄的选择性膜层(即,表面层),其在分级微孔层上方具有大约大于1014个几乎单分散的介孔(mesopore)/m2。
通过均聚物或小分子共混使均孔膜的杂化能够调节孔径,并且可产生纯水通量、溶质脱除特性(solute rejection characteristics)和水蒸气传输速率(water vaportransport rate,WVTR)。通过并入小分子来实现调节孔径,所述小分子包括但不限于十五烷基酚、十二烷基酚、2-4’-(羟基苯偶氮)苯甲酸(HABA)、1,8-萘-二甲醇、3-羟基-2-萘甲酸和6-羟基-2-萘甲酸;无机和有机酸,其包括但不限于氢氟酸、盐酸、硝酸、甲酸、乙酸、丙酸、低级烷基二羧酸;碱,其包括但不限于吡啶、氨、氢氧化铵、氢氧化钠、氢氧化钾、胺类、多胺类(三乙胺、三乙醇胺)、酰胺类(乙酰胺、甲酰胺);包括但不限于甘油和其他多元醇类、醌类、氢醌类、儿茶酚类、碳水化合物;以及小聚合物,其包括但不限于聚丙烯酸、聚乙烯吡啶、聚环氧乙烷、天然来源的聚合物(纤维素、壳聚糖、复合碳水化合物)。
本发明的另一个应用是作为传感器的一部分,例如化学或生物化学检测和/或定量。例如,在目标种类与材料相互作用时,激活材料上的特定响应:电阻、电容、颜色。在该实施方案中,目标种类与材料的相互作用引起材料的可检测的变化或响应(例如膜的分光光度曲线的变化),允许检测和/或量化目标种类。目标种类可以是但不限于分子、生物分子(例如蛋白质)、生物结构(例如特定细胞类型)、病原体、化学结构(例如纳米颗粒)、分子上的部分、生物分子上的部分、生物结构上的部分或化学结构上的部分。
在一个实施方案中,该材料用于检测目的分析物的方法,其使含有至少一种目的分析物的介质与该材料接触。
本发明的材料/膜包括并入到纺织品或传感器装置中。
在一个实施方案中,用至少一种表面抗生素涂覆或浸渍膜或支持物中的至少一种。例如,新霉素、多黏菌素B、莫匹罗星(mupirocin)、杆菌肽、红霉素或磺胺醋酰钠。
在一个实施方案中,用至少一种凝固剂(clotting agent)涂覆或浸渍膜或支持物中的至少一种。例如,凝血酶、鞣质、金属盐(例如锌和钙)、明胶、胶原蛋白、纤维蛋白或其他血液因子。
在一个实施方案中,用至少一种药剂涂覆或浸渍膜或支持物中的至少一种以促进愈合。例如,维生素、蛋白质、氨基酸、酶或药物。更具体地,一些实例包含:芦荟(aloe vera)凝胶或提取物、维生素A、维生素B1、维生素B3、甘氨酸、水杨酸胆碱或胶原蛋白。
在一个实施方案中,用至少一种时间释放的药物涂覆或浸渍膜或支持物中的至少一种。例如,用于实现时间释放或控制释放的化合物包括:羟丙基甲基纤维素、聚(乙烯醇)、聚(丙烯酸)或蜡。
在一个实施方案中,用至少一种响应性释放药物涂覆或浸渍膜或支持物中的至少一种。例如,药物在暴露于特定蛋白质或病原体时释放。
在一个实施方案中,用至少一种防腐剂涂覆或浸渍膜或支持物中的至少一种。例如,苯扎氯铵、氯己定、阿来西定、聚维酮碘、苄索氯铵、氯二甲酚(chloroxylenol)、醇类或三氯生(triclosan)。
在一个实施方案中,用至少一种麻醉剂涂覆或浸渍膜或支持物中的至少一种。例如,苯佐卡因、利多卡因、丁卡因、普莫卡因、苯酚、薄荷醇、丙胺卡因或达克罗宁。
在一个实施方案中,本发明包含用于将绷带固定至身体的黏合剂。在一些实例中,黏合剂是压敏黏合剂。例如,至少一种压敏黏合剂聚合物或嵌段共聚物,其包括例如:聚(丙烯酸酯)、聚(甲基丙烯酸酯)、橡胶、聚(异戊二烯)、聚(丁二烯)、聚(丙烯酸酯)、聚(丙烯酸)、聚(醋酸乙烯酯)等。
在一个实施方案中,本发明用作烧伤绷带。
在一个实施方案中,本发明用作口腔绷带。
在一个实施方案中,本发明用作体内使用的绷带。
在一个实施方案中,绷带在某段时间之后是可生物吸收的。例如,该材料包含可生物吸收的聚合物或包含聚合物或聚合物嵌段的共聚物,例如:聚(乳酸)、聚(乙醇酸)、聚酯类、聚(己内酯)、聚(原酸酯)、聚(羟基丁酸戊酸酯)、聚(二烷酮)或聚(三亚甲基碳酸酯)。
在一些实施方案中,绷带具有适合于特定的用途或身体部位的二维或三维几何布置。例如,波状绷带(contoured bandage)更合适地适合关节。
在一个实施方案中,用至少一种非活性成分涂覆或浸渍膜或支持物中的至少一种用于储存、稀释或递送涂层或浸渍。例如,纯水、甘油、石油冻(petroleum jelley)或羊毛脂。
在一个实施方案中,用至少一种抗氧化剂涂覆或浸渍膜或支持物中的至少一种用于稳定性和保质期。例如,抗坏血酸、生育酚类、类胡萝卜素类、胡萝卜素类或丁羟甲苯(butylated hydroxytoluene)。
在一个实施方案中,绷带的一部分具有入口、阀或隔膜,使得物质可被引入或提取至绷带或伤口或者从绷带或伤口引出或提取出而无需移除绷带。在一个实例中,药物可在有或没有针的情况下从注射器注射而不移除绷带。在一个实例中,体液样品可用注射器(有或没有针)从绷带或伤口提取而不移除绷带。
在一个实施方案中,绷带作为填料直接***到伤口中。
在一个实施方案中,绷带并入有指示剂。例如,所述指示剂可指示:绷带需要更换、缺乏水分、过量水分、病原体的存在、药物或表面药剂的消耗、伤口凝固等。
在一个实施方案中,绷带与保湿剂(hydrating agent)或润湿剂(humectant)一起包装,以保持膜上的水分。例如,纯水、甘油或芦荟凝胶。
在一个实施方案中,绷带是干燥包装的。
Claims (19)
1.柔性复合绷带,其包含:a)均孔自组装纳米多孔膜;b)柔性和/或弹性支持物;以及c)任选的生物相容性非黏性剂,其在所述均孔膜和支持物中的至少一种中。
2.权利要求1所述的柔性复合绷带,其包含:a)孔径为1至200nm的均孔自组装纳米多孔膜;b)柔性和/或弹性支持物;以及c)任选的生物相容性非黏性剂,其在所述均孔膜和支持物中的至少一种中,其中所述膜和所述支持物中的至少一种是生物相容性的。
3.权利要求1所述的柔性复合绷带,其包含:孔径为1至60nm的均孔自组装纳米多孔膜;b)柔性和/或弹性支持物;以及c)任选的生物相容性非黏性剂,其在所述均孔膜和支持物中的至少一种中,其中所述膜和所述支持物中的至少一种是生物相容性的。
4.提供伤口处理***的方法,其包括使孔径为1至200nm的均孔自组装纳米多孔膜与柔性和/或弹性支持物相缔合以形成整体绷带,其中生物相容性非黏性剂与所述均孔膜和支持物中的至少一种相缔合,并且所述膜和支持物中的至少一种是生物相容性的。
5.根据权利要求1所述的绷带,其中所述支持物包含至少一层空气可透过的自支持生物相容性材料。
6.权利要求1所述的绷带,其中所述均孔膜布置在最外层上。
7.权利要求5所述的绷带,其中所述支持物包含多个层,并且所述均孔膜布置在所述多个层中的两个之间。
8.根据权利要求1所述的绷带,其中生物相容性非黏性剂涂覆在所述均孔膜和支持物中的至少一种上。
9.根据权利要求1所述的绷带,其中所述绷带是病原体特异性的。
10.根据权利要求1所述的绷带,其中所述膜和支持物中的至少一种包含药剂。
11.根据权利要求1所述的绷带,其中所述膜和支持物中的至少一种包含药物。
12.药盒,其包含不同的根据权利要求1所述的病原体特异性绷带。
13.治疗伤口的方法,其包括将根据权利要求1所述的绷带附着至伤口。
14.治疗伤口的方法,其包括选择权利要求9所述的病原体特异性绷带,并将所述病原体特异性绷带附着至伤口。
15.包含不同的病原体特异性绷带的药盒,至少一个第一绷带包含孔径为1至60nm的均孔自组装纳米多孔膜;至少一个第二绷带包含孔径为1至100nm的均孔自组装纳米多孔膜;另外的绷带包含具有至少包括1至200nm孔径的其他孔径的均孔自组装纳米多孔膜。
16.制品,其包含:a)孔径为1至200nm的均孔自组装纳米多孔膜;b)柔性和/或弹性支持物;其中所述制品提供了生物相容性、可生物降解性、抗细菌/微生物、非黏性、增强细胞生长和药物洗脱中的至少一种。
17.权利要求16所述的药盒,其中所述绷带提供了生物相容性、可生物降解性、抗细菌/微生物、非黏性、细胞生长增强和药物洗脱中的至少一种。
18.传感器,其包含权利要求1所述的材料。
19.检测至少一种目的分析物的方法,其使含有所述目的分析物的介质与权利要求1所述的材料接触。
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US62/426,935 | 2016-11-28 | ||
PCT/US2017/062681 WO2018098108A1 (en) | 2016-11-28 | 2017-11-21 | Wound treating system and methods of using and assembling |
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CN110725044B (zh) * | 2019-11-08 | 2021-02-02 | 南通大学 | 一种复合型结构弹性医用绷带及其制备方法 |
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- 2017-11-21 CN CN201780073476.XA patent/CN110475530A/zh active Pending
- 2017-11-21 JP JP2019548866A patent/JP2020500678A/ja active Pending
- 2017-11-21 EP EP17874473.6A patent/EP3544558B1/en active Active
- 2017-11-21 CA CA3045012A patent/CA3045012A1/en active Pending
- 2017-11-21 US US16/463,256 patent/US20190307610A1/en not_active Abandoned
- 2017-11-21 MX MX2019006156A patent/MX2019006156A/es unknown
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JP2020500678A (ja) | 2020-01-16 |
WO2018098108A1 (en) | 2018-05-31 |
KR20190119574A (ko) | 2019-10-22 |
EP3544558A4 (en) | 2020-08-05 |
CA3045012A1 (en) | 2018-05-31 |
US20190307610A1 (en) | 2019-10-10 |
EP3544558B1 (en) | 2024-05-01 |
EP3544558A1 (en) | 2019-10-02 |
MX2019006156A (es) | 2020-08-10 |
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