CN102525737B - 医用敷料及使用该敷料的负压治疗装置 - Google Patents
医用敷料及使用该敷料的负压治疗装置 Download PDFInfo
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- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/26—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
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Abstract
本发明涉及一种医用敷料及使用该敷料的负压治疗装置,所述医用敷料包括第一织物层,其包括由聚氨酯形成的纤维或纱线;第二织物层,其包括由聚氨酯形成的纤维或纱线;以及多个线形支撑部,其织结于该第一织物层与第二织物层之间。
Description
技术领域
本发明涉及一种医用敷料,特别涉及一种由具有纤维形态且含有氨基甲酸酯重复单元的聚合物所纺制的医用敷料。
背景技术
全球过去为了护理慢性伤口,一直以来耗费相当大的医疗资源,慢性伤口主要产生的原因有,如糖尿病、神经病变、压疮、褥疮、以及血管病变等。因此,对于慢性伤口治疗的技术一直广受各界重视。慢性伤口护理用敷料的产品技术发展大略可分为:传统治疗敷料,例如使用绷带(Bandages)、纱布(Gauze)或创可贴(Band-Aid)等;湿式敷料,例如使用水凝胶(Hydrogel)、水胶体(Hydrocolloid)或泡沫(Foam)等;以及负压治疗(NegativePressureWoundTherapy,NPWT)。
历史上第一次公开贩卖关于医疗用途伤口照护的产品,可追溯自1874年德国公司制造的无菌脱脂棉,其功能仅止于单纯的覆盖创面,保护创口,成本极低,简便又便宜因而延用至今。然而,纱布或棉垫等传统敷料对于伤口虽有一定的保护作用,但仍往往无法有效阻隔外界环境,因而有易渗漏及易造成伤口重复感染发炎的缺点。
近年来针对难以愈合的伤口,诸如褥疮、压疮、糖尿病溃疡等创伤,主动且非侵入式的促进愈合治疗法的发展十分迅速,而负压治疗类的装置与敷料产品便为其中之一。NPWT伤口护理技术利用泵(pump)在伤口以及空气吸盘之间放置敷料,并施加大约50至120毫米汞柱不等的压力,因此可减少渗出液和局部水肿,而机械引力则可促进肉芽组织增生及增进局部血液循环。
目前负压敷料设计以聚氨酯泡沫或者平面纱布为主,泡沫结构主要缺点为泡沫敷料触感偏硬使得病患使用舒适度不佳、以及为了填充不规则伤口空腔因此必须裁剪使得医护人员的操作便利性不足,并有移除不完全的风险和在移除时会造成伤口的沾黏及破坏,而使病人倍感疼痛。此外,平面纱布型敷料进行负压治疗缺点则为缺乏立体结构支撑,当平面纱布型敷料受到压力挤压后,平面纱布结构紧密贴合,无法有效保持渗出液通透所需要的管道;此外也会有移除时会造成伤口的沾黏及破坏,而使病人倍感疼痛的问题。
因此,负压治疗所搭配使用的敷料设计,在伤口床压力分布表现、伤口渗出液移除效率、以及伤口沾黏及操作上仍有相当大的改进空间。此外,纱布或薄膜状敷料进行伤口床的保护时,一般消毒纱布或薄膜状敷料由于无法有效控制伤口床的湿润度,且材料本身具高沾黏性,使肉芽组织容易长入纤维织物中,因此在更换敷料时会造成再次损伤。
发明内容
为改良目前用于伤口的敷料缺点,本发明提供一种医用敷料,其包括:第一织物层,其包括由聚氨酯形成的纤维或纱线;第二织物层,其包括由聚氨酯形成的纤维或纱线;以及多个线形支撑部,其织结于该第一织物层与第二织物层之间。
该第一织物层与第二织物层的制备主要以纤维化加工方式将包括聚氨酯的材料制备成纤维,再通过纺织技术织成具有纤维形态的层状织物,其中,纤维选自单丝纤维、复丝纤维或其二者;该纱线选自单股纱线、多股纱线或其二者。此外,该第一织物层与第二织物层的表面具有多个孔洞,且该多个孔洞的平均孔洞面积范围为1×10-4至1×102mm2。
本发明的纤维形态敷料,可用于伤口一般性保护,为了控制渗液通透速度以及控制伤口床湿润度,可通过第一织物层与第二织物层的孔洞面积大小组成不同进而调整结构设计。当与伤口接触层的织物孔洞较大(平均孔洞面积可介于1×10-2至1×102mm2),而与空气接触层的织物孔洞小时(平均孔洞面积可介于1×10-4至1mm2),通过不对称孔洞结构设计,能够实现对伤口部位渗出液排除的控制,并可实现控制湿蒸气通过率(Moisturevaportransmissionrate,MVTR)效能,MVTR控制可介于50至50,000g/m2/24hr,优选100至20,000g/m2/24hr。此外,通过控制第一织物层与第二织物层材料的亲/疏水性也可有助于控制渗出液移除或者伤口湿润程度,具体来说上述疏水性材料可为含有常规氨基甲酸酯重复单元的聚合物;亲水性材料为含有常规氨基甲酸酯重复单元并同时具有亲水链段组成的聚合物。
本发明的纤维形态敷料,可作为快速或大量伤口渗出液吸收用,可通过调整第一织物层与第二织物层的孔洞大小、调整第一织物层与第二织物层的材料亲/疏水性、调整第一织物层与第二织物层之间多个线形支撑部材料亲/疏水性、以及调整第一织物层与第二织物层之间多个线形支撑部位空间孔隙密度来实现结构设计。具体来说,该疏水材料为含有常规氨基甲酸酯重复单元的聚合物或上述材料所制成的纤维或纱线;以及该亲水材料为含有氨基甲酸酯重复单元并同时具有亲水链段组成的聚合物,或上述材料所制成的纤维或纱线,上述具有亲水性质的纤维或纱线具有吸收水分或渗出液的能力,且该吸收渗液的能力为该纤维敷料单位体积的5%至1000%,优选10%至500%。
本发明的纤维形态敷料可作为负压治疗的伤口填充用,可通过调整第一织物层与第二织物层的孔洞大小、调整第一织物层与第二织物层的材料亲/疏水性、调整第一织物层与第二织物层之间多个线形支撑部材料亲/疏水性、以及调整第一织物层与第二织物层之间多个线形支撑部位空间孔隙密度来实现对伤口部位渗出液的排除能力。具体来说,紧靠伤口床(伤口接触面)的织物层孔隙可以较小,如此可以让伤口渗出液顺利通透也可以防止新生组织长入纤维敷料内部,避免移除时撕裂新生组织以及造成病患疼痛,具体来说该第一织物层(伤口接触面)的平均孔洞面积可小于1mm2,优选可介于1×10-4至1mm2;第二织物层的平均孔洞面积可大于1×10-2mm2,优选可介于1×10-2至1×102mm2;第一织物层与第二织物层也可具备有相同的平均孔洞面积,平均孔洞面积范围可为1×10-4至1×102mm2。
此外,本发明的纤维形态敷料作为负压治疗的伤口填充用时,第一织物层与第二织物层间的支撑部位空间孔隙密度以及支撑强度的结构设计可影响液体通透所需的毛细通道,因此进而影响渗出液通透效率以及负压操作时的压力分布。具体来说,本发明的纤维敷料用于负压操作时,血液仿体(ComputerizedImagingReferenceSystems,Inc生产的Model046,bloodmimickingfluid,Lot#CGB3120)于高于600毫米汞柱压力下,液体通过速率可大于50mg/sec,优选的液体通过速率可大于70mg/sec;伤口部位填充纤维敷料进行负压操作时,压力分布差可小于10毫米-汞柱,优选小于5毫米-汞柱。
对于本发明纤维敷料所使用的材料,在具体实施方案中,该聚氨酯聚合物包括脂肪族聚氨酯、芳香族聚氨酯、含亲水链段的脂肪族聚氨酯、含亲水链段的芳香族聚氨酯或前述的组合,且该亲水链段位于该脂肪族聚氨酯或芳香族聚氨酯的主链,或者以侧链形式键合至该脂肪族聚氨酯或芳香族聚氨酯。举例而言,该亲水链段以酯键或氨基甲酸酯键键合至该脂肪族聚氨酯或芳香族聚氨酯。此外,该亲水链段包括聚乙二醇(polyethyleneglycol,PEG)、聚环氧乙烷(polyethyleneoxide,PEO)、聚乙烯吡咯烷酮(polyvinylpyrrolidone,PVP)、聚乙烯醇(polyvinylalcohol,PVA)、聚丙烯酸(polyacrylicacid,PAA)、聚甲基丙烯酸(polymethacrylicacid,PMA)或前述的组合。
在一个具体实施方案中,该亲水链段具有下式(I)或式(II)的结构:
其中,n为1至20,000的整数;
m为1至50,000的整数;以及
该式(I)或式(II)的亲水链段以末端的氧键合至该聚合物侧链上。
在另一具体实施方案中,该聚合物是由二苯甲烷二异氰酸酯与选自具有下式(III)或式(VI)结构的含二醇基团的亲水链段反应形成的含有氨基甲酸酯重复单元的聚合物:
式(III)、
式(IV);
其中,n为1至20,000的整数;
m为1至50,000的整数。
在另一具体实施方案中,该医用敷料还可包括抗菌成分,其选自银、碘、锌、铜及抗生素所组成群组的一种或多种抗菌成分,且该抗菌成分位于该第一织物层、第二织物层或多个线形支撑部的表面。此外,该抗菌成分可通过结合剂结合于该第一织物层、第二织物层或多个线形支撑部的表面。
另一方面,当该医用敷料处于一局部负压环境,于高于600毫米-汞柱压力下,液体通过该医用敷料的平均速率大于50毫克/秒;优选地,该局部负压为635毫米-汞柱时,其液体通过该医用敷料的速率大于110毫克/秒。
本发明还提供一种负压治疗装置,其包括:一医用敷料,包括:第一织物层,其包括由聚氨酯形成的纤维或纱线;第二织物层,其包括由聚氨酯形成的纤维或纱线;以及多个线形支撑部,其织结于该第一织物层与第二织物层之间;
一气密组件,其贴附于该医用敷料上;
一真空单元;以及
一连通管,其两端分别连接该气密组件与该真空单元;其中,该负压治疗装置通过该医用敷料填充或覆盖于患部表面,并可配合一气密组件,以建立该患部的局部负压环境。
本发明的医用敷料可借助其结构中纤维交织造成的空间或孔洞所产生的毛细现象,赋予该医用敷料吸收伤口渗出液的功能。此外,本发明的医用敷料具有聚氨酯形成的纤维或纱线,通过纤维结构的设计可使纤维敷料具有柔软以及服贴伤口的特性;而含有亲水性链段的氨基甲酸酯重复单元的聚合物材料,可避免敷料与伤口床组织间产生沾黏。
附图说明
图1是本发明医用敷料的立体示意图;以及
图2是本发明医用敷料的用于负压治疗装置的示意图。
【附图符号说明】
1医用敷料
11第一织物层
13第二织物层
15线形支撑部
2负压治疗装置
21气密组件
22组织
23医用敷料
24真空单元
25连通管
26容器
27过滤器。
具体实施方式
以下通过特定的具体实施例说明本发明的实施方式,本领域技术人员可由本说明书所揭示的内容轻易地了解本发明的优点及功效。本发明也可通过其它不同的实施方式加以施行或应用,本说明书中的各项细节也可基于不同观点与应用,在不悖离本发明所揭示的精神下赋予不同的修饰与变更。
本文所利用的纤维加工原理,已为本领域技术人员所能明了,因此下文中的说明不再对其作完整描述。
请参阅图1,其为本发明提供的医用敷料1,包括:第一织物层11,其包括由聚氨酯形成的纤维或纱线;第二织物层13,其包括由聚氨酯形成的纤维或纱线;以及多个线形支撑部15,其织结于该第一织物层11与第二织物层13之间。
该第一织物层与第二织物层的制备主要以纤维化加工方式将含有聚氨酯的聚合物制备成纤维,再通过纺织技术织成,其中,纤维选自单丝纤维、复丝纤维或其二者;该纱线选自单股纱线、多股纱线或其二者混合。此外,该纤维或纱线的纤维细度范围为0.01丹尼至1000丹尼,优选为0.1丹尼至500丹尼。
本发明医用敷料的第一织物层与第二织物层是以梭织、针织、圆编或经编形成的结构,其厚度介于0.01至100mm,优选为0.1至10mm。同样地,该多个线形支撑部也与第一织物层与第二织物层以一体编织方式完成。
此外,该第一织物层与第二织物层的表面具有多个孔洞,且该多个孔洞的平均孔洞面积范围为1×10-4至1×102mm2,优选的平均孔洞面积范围为1×10-2至25mm2。当然,本发明的医用敷料,尤其是各线形支撑部之间也可构成多个孔洞,且该孔洞结构的面积可相同或不同。从而,本发明的医用纤维敷料具有连续且互相连通的通道,以利于控制伤口渗出液穿透该敷料的速率。另外,本发明的医用敷料的总体密度范围为0.01至0.99g/cm3,优选为0.1至0.99g/cm3。至于在伤口渗出液吸收方面,本发明医用敷料的吸收渗液能力为该纤维敷料单位体积的5%至1000%,优选10%至500%。
本发明的医用敷料于负压治疗中作为填充敷料时,以可造成伤口床部位局部低于大气压力的方式排除渗出液,其中,该伤口床部位局部低于大气压力范围759至500mmHg。该伤口部位填充纤维敷料进行负压操作时,压力分布差小于10毫米-汞柱,优选小于5毫米-汞柱。
为使本发明的医用敷料更柔软、与伤口服贴性佳、并有较佳的生物兼容性,所使用的纤维或纱线的硬度范围为肖氏50A至肖氏80D,优选为肖氏70A至肖氏80D,而该纤维或纱线的纤维细度范围为0.01丹尼至1000丹尼,优选为0.1丹尼至500丹尼。
本发明中,该聚氨酯聚合物包括脂肪族聚氨酯、芳香族聚氨酯、含亲水链段的脂肪族聚氨酯、含亲水链段的芳香族聚氨酯或前述的组合。此外,该医用敷料的纤维或纱线还可包括:热塑性聚酯类高分子材料、生物可吸收性高分子材料、抗菌性材料、其它防止组织/细胞贴附或沾黏的材料、止血功能材料、促进伤口血液循环材料或除臭或吸收臭味的材料,在织物层的制备中,可混合一种或多种上述材料或将这些材料加工为纤维后通过纺织技术制备层状织物。
本发明的聚氨酯聚合物的实例包括脂肪族聚氨酯、芳香族聚氨酯、含亲水链段的脂肪族聚氨酯或含亲水链段的芳香族聚氨酯。其中,该聚氨酯可为含亲水链段的脂肪族聚氨酯或含亲水链段的芳香族聚氨酯;该亲水链段位于该脂肪族聚氨酯或芳香族聚氨酯的主链或者以侧链形式键合至该脂肪族聚氨酯或芳香族聚氨酯,且该亲水链段以酯键或氨基甲酸酯键键合至该脂肪族聚氨酯或芳香族聚氨酯。
该亲水链段包括聚乙二醇、聚环氧乙烷、聚乙烯吡咯烷酮、聚乙烯醇、聚丙烯酸、聚甲基丙烯酸或前述的组合。
该脂肪族聚氨酯或芳香族聚氨酯的每一主链中,该亲水链段的重复单元数大于1,且该亲水链段的分子量小于500,000,例如,100至500,000,或者小于200,000,最优选小于100,000。
在生物可吸收性高分子材料中,其实例可包括聚己内酯(polycaprolactone,PCL)、聚乳酸(polylacticacid,PLA)、聚羟基乙酸(polyglycolicacid,PGA)、聚乳酸-共-羟基乙酸共聚物(polylactic-co-glycolicacidcopolymer,PLGA)、聚己内酯-聚乳酸共聚物(polycaprolactone-polylacticacidcopolymer,PCL-PLA)、聚己内酯-聚乙二醇共聚物(polycaprolactone-polyethyleneglycolcopolymer,PCL-PEG)或其混合物。
在抗菌性材料中,其实例可包括加入第一织物层或第二织物层表面以及多个线形支撑部的表面或医用敷料整体中的具有抗菌或抑菌成分的银、碘、锌、铜、抗生素或药物等。其中,如果仅表面含有上述具有抗菌或抑菌成分的物质,可于第一织物层、第二织物层表面以及多个线形支撑部或敷料形成后,以浸渍、喷涂、或溅射等表面处理方法形成于该材料或敷料的表面;如整体含有上述具有抗菌或抑菌成分的物质时,可于纤维形成加工前,将银、碘、锌、铜、抗生素或药物等成分均匀混合入用以制备纤维的材料的组成中,例如聚合物材料中,再进行纤维加工。
至于在该表面处理方法中,优选为浸渍方法。其中,该浸渍方法包括在一种或两种以上的有机溶剂中将所添加的抗菌或抑菌成分,通过溶蚀原理将该抗菌或抑菌成分结合于需要表面处理的纤维。
此外,也可通过结合剂将抗菌或抑菌成分结合于纤维表面,其中,该结合剂可选自一般聚氨酯材料、水性聚氨酯(water-borne
polyurethane)、亲水性聚氨酯(hydrophilicpolyurethane)、两性聚合物(amiphilicpolymer)或其组合。
在进行纤维的表面处理步骤时,可进一步包含干燥步骤,其中,该干燥温度范围为10℃至200℃,优选为25℃至120℃。
在防止组织/细胞贴附或沾黏材料中,除了在含有氨基甲酸酯重复单元的聚合物侧链含有亲水链段外,另一实例可包括在含有氨基甲酸酯重复单元的聚合物主链中添加聚乙二醇、聚氧化乙烯、聚乙烯吡咯烷酮、聚乙烯醇、聚丙烯酸、聚甲基丙烯酸或其组合的线性共聚物。
在止血功能材料中,其实例可包括选自氧化纤维素(Oxidizedcellulose,OC)、氧化再生纤维素(OxidizedRegeneratedCellulose,ORC)、胶原蛋白(collagen)、明胶(gelatin)、纤维蛋白胶(fibringlue)或甲壳素(Chitosan)及其衍生物等促进血液凝固的成份。该促进血液凝固的成份可形成于纤维材料表面或加入所形成的纤维中,其中,若表面含有上述促进止血的成份时,可在制成医用敷料后,再以浸渍或喷涂方式结合于该医用敷料表面。
在该表面处理方法中,该浸渍方法可包括在一种或两种以上的有机溶剂中将所添加的氧化纤维素、氧化再生纤维素、胶原蛋白、明胶、纤维蛋白胶、甲壳素或其衍生物等促进血液凝固成份结合于该医用敷料表面。当然,也可使用结合剂。此外,还可包含前述的干燥步骤。
在促进伤口血液循环材料中,其实例包括发射近红外线以及远红外线的材料,且优选金属或氧化金属材料,其中,该金属材料可为钛(Titanium)、锗(Germanium)或其它具有发射近红外线以及远红外线的材料,而该氧化金属材料可为氧化锌(Zincoxide)、氧化铝(Aluminiumoxide)、氧化镁(MagnesiumOxide)或其它发射近红外线以及远红外线的材料。
该发射近红外线以及远红外线的材料可以微粒子或纳米粒子的形态混合于本发明医用敷料的具有纤维型态的材料中,其中,该粒子的粒径小于100μm,优选小于50μm。
在除臭或吸收臭味的材料中,其以化学或物理方式吸附伤口床所产生氨臭味或其它臭味来源,其中,该吸附臭味的材料可选自金属氧化物材料或活性碳吸附材料。该金属氧化物材料例如可为氧化锌、氧化铝、氧化镁或其它吸附臭味的材料,以整体混合或表面涂布方式添加于本发明的医用敷料。
本发明中选用的具有氨基甲酸酯重复单元的聚合物材料,相对于聚四氟乙烯(PTFE)、硅(silicon)、聚氯乙烯(PVC)等常见高分子材料,热塑性聚氨酯树脂(TPU)或者氨基甲酸酯重复单元的聚合物由于分子结构中具有特殊的软链段(softsegment)及硬链段(hardsegment)的相分离(phaseSeparation)结构,因此会表现出TPU材料独特的弹性以及柔软性质,而含有氨基甲酸酯重复单元的聚合物材料具有宽广的加工范围与可应用方式,且含有氨基甲酸酯重复单元的聚合物本身具有优异的机械与弹性性质及宽广的软硬度调整范围与具有极好的血液兼容性(bloodcompatibility)以及优异的生物兼容性(biocompatibility),因此更适用于应用于伤口敷料(wounddressing)产品。
请参阅图2,其是本发明用于治疗组织的负压治疗装置2,包括:本发明的医用敷料23;气密组件21,其贴附于该医用敷料23上,并界定该气密组件21与组织22之间的空间;真空单元24;以及连通管25,其两端分别连接该气密组件21与该真空单元24,其中,该负压治疗装置2通过该医用敷料23覆盖于患部表面,以建立该患部的局部负压环境。该真空单元24可为泵,连通管25可为医疗用途的导管,该气密组件21可为半钢性及可适度变形的杯体或者一软质膜状物质。
前述用于治疗组织的负压治疗装置2,还可包括容器26,其设于气密组件21与真空单元24之间,并通过连通管25连接,以容纳所抽出的液体。此外,还可包括过滤器27,其插置在该容器26与真空单元24之间的连通管25中。
以下通过特定的具体实施例进一步说明本发明的特点与功效,但非用于限制本发明的范畴。
实施例
亲水性聚氨酯材料的合成
制备例1PVP-OH的合成
将N-乙烯基-2-吡咯烷酮(N-vinyl-2-pyrrolidone,VP)加入预先使用分子筛除水的二甲基乙酰氨(Dimethylacetamide,DMAc)(179ml),均匀混合后,再依次加入偶氮二异丁腈(2,2′-Azobisisobutyronitrile,AIBN)及硫基乙醇(Mercaptoethanol,ME)至反应瓶,全程通氮气,加热至60℃反应24小时,反应完毕后,使用减压浓缩机抽干二甲基乙酰氨(DMAc)溶剂后,将产物溶解于70ml二氯甲烷,完全溶解后倒入700ml乙醚中沉淀(1∶10),产物置于真空烘箱中,60℃干燥24小时,得到下式PVP-OH结构的产物。各批号所添加的N-乙烯基-2-吡咯烷酮、硫基乙醇及合成的各产物数据如下表一所示。
该式PVP-OH中,n为1至60至440的整数。
表一
制备例2合成具有二醇基团的PVP衍生物
将PVP-OH(制备例1的批号#3,PVP-OH-980730-2)在60℃真空除水12小时后,将PVP-OH(46g,3.82mmol)置入500ml三颈反应瓶,架设机械搅拌装置以及冷凝管,通氮气,加入100ml经由分子筛除水的二甲基亚砜(Dimethylsulfoxide,DMSO),加热至60℃溶解。待完全溶解后开启反应瓶的玻璃塞,加入二苯基甲烷二异氰酸酯(4,4’-diphenylmethanediisocyanate,MDI)粉末(0.98g,3.90mmol),反应3小时,得到产物PVP-NCO。
在内置有PVP-NCO(46.98g,3.82mmol)溶液的500ml反应瓶中,直接以针筒注射季戊四醇(Pentaerythritol)(0.26g,1.86mmol),并在60℃反应4小时。反应完毕后加入适量二丁基胺(Dibutylamine,DBA)(0.05g,0.38mmol)去除NCO官能基的活性。使用减压浓缩机移除二甲基亚砜(水浴温度60至70℃)。接着,将剩余残质溶于二氯甲烷中,在乙醚中(1∶10)沉淀两次,60℃真空干燥后得到具有二醇基团的PVP衍生物。
使用凝胶渗透色谱(GPC)分析该具有二醇基团的PVP衍生物的分子量以及使用1H-NMR分析接枝率多寡。结果,所得具有二醇基团的PVP衍生物的分子量为Mn:13,600、Mw:28,500、PDI=2.1,以及1H-NMR测得的接枝率为108%。该具有二醇基团的PVP衍生物具有下式(III)结构。
式(III)
制备例3具有二醇基团的PEG衍生物的合成
将市售的聚乙二醇单甲醚(methyletherpolyethyleneglycol,mPEG)(150g,0.03mol)置入1L三颈反应瓶,直接以减压浓缩机80℃除水2小时,加入368ml经由分子筛除水的二甲基亚砜,加热至60℃溶解。待完全溶解后,加入二苯基甲烷二异氰酸酯(7.66g,0.0306mol)粉末溶解至30ml二甲基亚砜液体,反应3小时,产物即为mPEG-NCO。
在内置有mPEG-NCO(157.7g,0.03mol)溶液的500ml反应瓶中,直接以针筒注射季戊四醇(1.98g,0.015mol),并于60℃反应4小时。反应完毕后加入适量二丁基胺(0.39g,0.003mol)去除NCO官能基的活性。使用减压浓缩机移除二甲基亚砜,接着将剩余残质溶于二氯甲烷,在乙醚中(1∶10)沉淀两次,真空干燥后白色固体即为具有二醇基团的PEG衍生物。具有二醇基团的PEG衍生物具有下式(IV)结构,其分子量为:Mn:6,400、Mw:8,300、PDI:1.3。
式(IV)
制备例4侧链键合有亲水链段的聚氨酯的合成
以溶液聚合法合成侧链键合有亲水链段的聚氨酯,其中,二异氰酸盐采用芳香族的二苯基甲烷二异氰酸酯(4,4’-diphenylmethanediisocyanate,MDI);聚醚多元醇(Polyetherpolyol)采用聚四甲基醚二醇(PTMEG1,000);链延长剂则以前述的PEG亲水化二醇(PEG-diol)或PVP亲水化二醇(PVP-diol),与1,4-丁二醇(1,4-BDO)搭配做调整,反应溶剂为N,N-二甲基乙胺,反应温度为65±5℃,控制反应系统中固含量为20重量%,合成配方如下表二及表三所示。
表二含PVP亲水侧链的聚氨酯合成配方
表三含PEG亲水侧链的聚氨酯合成配方
测试例1细胞贴附的测试
利用体外细胞贴附试验测试侧链键合有亲水链段的聚氨酯抑制细胞贴附能力,测试条件与方法如下:细胞种类为L-929,细胞种植数为2×104/孔(well)(12孔培养板(wellCultureplate)),细胞培养条件为7℃,5%CO2,空白对照组为12孔培养板,测试样品为直径21mm的圆形薄片。测试步骤如下:
将具有亲水链段的聚氨酯及不具有亲水链段的聚氨酯(控制组)制成圆形薄膜试片(直径20mm,厚度0.5mm),并平置于12孔培养板底层,以无毒橡胶环将试片平整固定。加入2ml内含2×104细胞的细胞悬浮液,使之均匀分布并放置于细胞培养箱中培养18小时,使细胞贴附。接下来以移液管(pipette)移去培养基,再分别加入2ml磷酸盐缓冲溶液(DPBS)移除未贴附的悬浮细胞。然后加入2ml适当浓度的中性红(neutralred)反应1小时,以倒立式显微镜观察。每一孔板(wellplate)区分为5至6个区域拍照存盘,并计算显微镜100倍单位面积下,细胞贴附的总数,并统计每一孔板细胞贴附平均数。每一试片依上述方式分别进行三次重复试验,比较不同原料组成试片的细胞贴附程度和差异性。抑制细胞贴附性能如下表四与表五所示。
表四含PVP亲水侧链的聚氨酯材料细胞贴附结果
表五含PEG亲水侧链的聚氨酯材料细胞贴附结果
测试例2伤口沾黏的测试
利用大鼠模式动物试验测试侧链键合有亲水链段的聚氨酯的抑制伤口沾黏能力,测试条件与方法如下:于大鼠上背先行以(2.5×2.5cm)范围开创,3天后将测试样品固定于伤口床,在第7天进行动物麻醉,麻醉后将大鼠绑上缝线并固定于一个角落,以手持式拉力计将测试样品以反向45°撕离伤口床,纪录测试样品拉离组织的最大拉力值,撕开速度固定为1cm/s,结果如下表六所示。
表六含亲水侧链的聚氨酯材料抑制伤口组织沾黏结果
制备例5热可塑性聚氨酯纤维的制造
分别使用下列聚氨酯材料:
(1)LubrizolCorporation生产的芳香族聚醚型系列TPU;
(2)GreatEasternResinsIndustrialCo.Ltd.(GRECO)生产的ISOTHANE1000芳香族聚酯型系列TPU;以及
(3)GreatEasternResinsIndustrialCo.Ltd.(GRECO)生产的ISOTHANE3000芳香族聚醚型系列TPU。
纤维采用熔纺方式制作(纺丝试验机为怡翔工程股份有限公司制造,型号:JOYSPPL03),熔纺加工前聚氨酯含水率需干燥至100ppm以下,各项熔纺加工条件以及纤维物性如表七所列。
表七聚氨酯材料纤维加工条件与性能测试
制备例6亲水性聚氨酯纤维的制造
原料使用LubrizolCorporation生产的脂肪族聚醚型系列TPU的亲水性聚氨酯以及CoatingChemicalIndustryCo.Ltd.(CCIC)生产的BE-5038A芳香族亲水性TPU的聚氨酯。
纤维仍采用熔纺方式制作(纺丝押出机为KillionExtrudersInc制造,型号:KLB-100;或纺丝试验机为怡翔工程股份有限公司制造,型号:JOYSPPL03)。熔纺加工前聚氨酯含水率需干燥至100ppm以下,各项熔纺加工条件以及纤维物性如表八所列。
表八亲水性聚氨酯材料纤维加工条件与性能测试
制备例7医用敷料的制备
使用制备例5的聚氨酯复丝纤维,以圆编方式织成本发明的医用敷料,圆编机为宽裕机械公司34KL圆编针织机,各项圆编加工条件以及性能测试如下表九所列。
表九圆编加工条件与性能测试
测试例3伤口渗出液排除效率的测试
以硅胶材料内空腔尺寸为:5×5×4cm作为伤口仿体,在伤口仿体底部中央以及侧边中央各埋入压力计传感器(sensor);并于伤口仿体底部两侧以22G钢针引流血液仿体,分别测试泡沫以及纤维敷料的液体排除效率,液体使用血液仿体(ComputerizedImagingReferenceSystems,Inc生产的Model046,bloodmimickingfluid,Lot#CGB3120)进行测试,并于测试后随即抛弃,测试压力为635毫米-汞柱,测试数据如下表十。
表十医用敷料与比较敷料操作性能测试
以上所述仅为本发明较佳实施例,并非用以限定本发明主张的权利;同时以上描述对于本领域技术人员应可明了与实施,因此其它未脱离本发明所揭示的精神下所完成的等效改变或修饰,均应包含在本申请的范围之内。
Claims (20)
1.一种医用敷料,其包括:
第一织物层,其包括由聚氨酯形成的纤维或纱线;
第二织物层,其包括由聚氨酯形成的纤维或纱线;以及
多个线形支撑部,其织结于该第一织物层与第二织物层之间,
其中,该聚氨酯系选自脂肪族聚氨酯及芳香族聚氨酯,以及
其中,该第一织物层与第二织物层的表面具有多个孔洞,且该第一织物层的平均孔洞面积介于1×10-4至1mm2,该第二织物层的平均孔洞面积介于1×10-2至1×102mm2,且该第一织物层的平均孔洞面积小于该第二织物层的平均孔洞面积。
2.根据权利要求1所述的医用敷料,其中,该纤维选自单丝纤维、复丝纤维或其二者;该纱线选自单股纱线、多股纱线或其二者。
3.根据权利要求1所述的医用敷料,其中,该纤维或纱线的细度范围为0.01丹尼至1000丹尼。
4.根据权利要求1所述的医用敷料,其中,该第一织物层与第二织物层具有梭织、针织、圆编或经编的结构。
5.根据权利要求1所述的医用敷料,其中,该医用敷料的总体密度介于0.01至0.99g/cm3。
6.根据权利要求1所述的医用敷料,其中,该聚氨酯包括含亲水链段的脂肪族聚氨酯、含亲水链段的芳香族聚氨酯或前述的组合。
7.根据权利要求6所述的医用敷料,其中,该聚氨酯为含亲水链段的脂肪族聚氨酯或含亲水链段的芳香族聚氨酯;该亲水链段位于该脂肪族聚氨酯或芳香族聚氨酯的主链,或者以侧链形式键合至该脂肪族聚氨酯或芳香族聚氨酯。
8.根据权利要求7所述的医用敷料,其中,该亲水链段以酯键或氨基甲酸酯键键合至该脂肪族聚氨酯或芳香族聚氨酯。
9.根据权利要求8所述的医用敷料,其中,该亲水链段包括聚乙二醇、聚环氧乙烷、聚乙烯吡咯烷酮、聚乙烯醇、聚丙烯酸、聚甲基丙烯酸或前述的组合。
10.根据权利要求7所述的医用敷料,其中,该亲水链段的分子量介于100至500,000之间。
11.根据权利要求1所述的医用敷料,其中,该纤维或纱线的硬度范围为肖氏50A至肖氏80D。
12.根据权利要求1所述的医用敷料,其中,该医用敷料单位体积的液体吸收量为5%至1000%。
13.根据权利要求1所述的医用敷料,进一步包含抗菌成分,其选自银、碘、锌、铜及抗生素所组成群组的一种或多种抗菌成分。
14.根据权利要求13所述的医用敷料,其中,该抗菌成分位于该第一织物层、该第二织物层或该多个线形支撑部的表面。
15.根据权利要求14所述的医用敷料,其中,该抗菌成分通过结合剂结合于该第一织物层、该第二织物层或该多个线形支撑部的表面。
16.根据权利要求15所述的医用敷料,其中,该结合剂选自聚氨酯及两性聚合物所组成群组的一种或多种。
17.根据权利要求1所述的医用敷料,其中,该医用敷料的厚度大于0.1mm。
18.根据权利要求1所述的医用敷料,其中,该芳香族聚氨酯系选自聚醚芳香族聚氨酯及聚酯芳香族聚氨酯。
19.一种负压治疗装置,包括:
一医用敷料,包括:
第一织物层,包括由聚氨酯形成的纤维或纱线;
第二织物层,包括由聚氨酯形成的纤维或纱线;以及
多个线形支撑部,织结于该第一织物层与第二织物层之间;
一气密组件,贴附于该医用敷料上;
一真空单元;以及
一连通管,其两端分别连接该气密组件与该真空单元,
其中,该聚氨酯系选自脂肪族聚氨酯及芳香族聚氨酯,以及
其中,该第一织物层与第二织物层的表面具有多个孔洞,且该第一织物层的平均孔洞面积介于1×10-4至1mm2,该第二织物层的平均孔洞面积介于1×10-2至1×102mm2,且该第一织物层的平均孔洞面积小于该第二织物层的平均孔洞面积。
20.根据权利要求19所述的负压治疗装置,其中,该芳香族聚氨酯-系选自聚醚芳香族聚氨酯及聚酯芳香族聚氨酯。
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CN102525737A (zh) | 2012-07-04 |
US20120150078A1 (en) | 2012-06-14 |
EP2462908A1 (en) | 2012-06-13 |
EP2462908B1 (en) | 2013-09-25 |
TWI465263B (zh) | 2014-12-21 |
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