CN107106334A - 具有多个粘合剂层的伤口敷料 - Google Patents
具有多个粘合剂层的伤口敷料 Download PDFInfo
- Publication number
- CN107106334A CN107106334A CN201580071938.5A CN201580071938A CN107106334A CN 107106334 A CN107106334 A CN 107106334A CN 201580071938 A CN201580071938 A CN 201580071938A CN 107106334 A CN107106334 A CN 107106334A
- Authority
- CN
- China
- Prior art keywords
- absorbability
- adhesive mass
- wound dressing
- back sheet
- hydrophile
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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Classifications
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/022—Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0259—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer
- A61F13/0266—Adhesive bandages or dressings characterised by the release liner covering the skin adhering layer especially adapted for wound covering/occlusive dressings
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Abstract
本公开提供了一种伤口敷料。所述伤口敷料包括具有第一主表面、第二主表面和背衬层周边的湿气可透过的背衬层;粘附到所述背衬层的所述第二主表面的至少一部分的吸收性亲水粘合剂,所述吸收性亲水粘合剂包括吸收性亲水粘合剂周边;设置在所述吸收性亲水粘合剂中的抗菌剂;具有第一侧、第二侧和多孔层周边的多孔层,所述第一侧粘附到所述吸收性亲水粘合剂;以及粘附到所述多孔层的所述第二侧的第二疏水粘合剂。所述第二主表面具有设置在其上的靠近所述背衬层周边的第一疏水粘合剂。所述吸收性亲水粘合剂周边的100%与所述背衬层重叠。所述多孔层周边的至少50%与所述吸收性亲水粘合剂重叠。
Description
相关申请的交叉引用
本专利申请要求2014年12月30日提交的美国临时专利申请号62/098,058和2015年2月6日提交的美国临时专利申请号62/112,714的优先权,这些临时专利申请的公开内容全文以引用方式并入本文中。
背景技术
透明膜敷料被广泛用作覆盖伤口的保护层,这是因为它们在潮湿环境中便于恢复,同时用于屏蔽污染液体和细菌。所述膜还凭借它们的屏蔽特性用作外科手术消毒盖布。符合以上描述的敷料和消毒盖布可以多个商品名诸如TEGADERMTM(美国明尼苏达州圣保罗的3M公司(3M Company,St.Paul,MN))、BIOCLUSIVETM(美国新泽西州新布朗斯维克的强生公司(Johnson&Johnson Company,New Brunswick,NJ))和OP-SITETM(英国赫尔的施乐辉公司(T.J.Smith&Nephew,Hull,England))购得。
另外,医用敷料保持在伤口上适当位置处的时间长度会受到多种因素的限制。在这些因素中,可以限制医用敷料使用寿命的因素为伤口内流体的积聚。一些医用敷料包括使用负压伤口治疗,其中可以从伤口敷料的下面移除流体,而无需从患者身上取下敷料。适合用于负压伤口治疗的敷料(诸如在如美国专利号4,969,880;5,261,893;5,527,293;以及6,071,267(均授予Zamierowski)中所述的那些)通常具有可危及其所敷伤口的无菌状态的构造。对于不规则表面上或周围的伤口,这些效果可变得复杂,所述不规则表面诸如膝、肘、肩、踵和踝。
控制皮肤上和伤口中的细菌是最大程度减少外科手术部位感染和改善急性伤口和慢性伤口的愈合的重要因素。然而,有效减少皮肤上的细菌的一些高浓度抗菌剂对于伤口愈合所需的细胞来说毒性过大。因此,需要可有效地减少皮肤上的细菌并且不伤害伤口愈合所需的细胞的敷料。
发明内容
本公开整体涉及伤口敷料。本公开的伤口敷料包括在伤口旁边的多孔材料层、在多孔层上方延伸到伤口周围皮肤上的吸收性亲水粘合剂层和高湿蒸汽透过率(以下为“MVTR”)粘合剂/膜背衬。吸收性亲水粘合剂将多余的伤口渗出物保持远离伤口并吸收伤口周围皮肤上多余的伤口周围湿气。它也是抗菌剂的来源,所述抗菌剂有助于在施用敷料时立即减轻伤口周围皮肤部分上的细菌。然而,吸收性亲水粘合剂不会将显著水平的抗菌剂释放到多孔层中,直到来自伤口的渗出物通过多孔层并到达吸收性粘合剂。吸收性亲水粘合剂也便于轻柔固定敷料和取下敷料。
本公开的伤口敷料的多孔伤口接触层提供一种结构,该结构便于将伤口渗出物迁移到吸收性亲水粘合剂,并且进一步延迟抗菌剂开始扩散到伤口,直到多孔层被伤口流体充分浸透。多孔伤口接触层还有助于通过将湿气从皮肤引导到吸收性亲水粘合剂来最小化伤口和伤口周围皮肤的浸渍。高MVTR背衬促进来自吸收性亲水粘合剂的湿气蒸发,从而使吸收性亲水粘合剂沿着多孔伤口接触层的周边保持其对皮肤的粘合和密封特性。
在任何实施方案中,多孔伤口接触层可为具有涂覆粘合剂的穿孔膜层压在其上的开孔泡沫。穿孔膜的面向伤口侧的粘合剂涂层可为疏水柔性有机硅粘合剂或基于疏水柔性丙烯酸酯的粘合剂,其提供温和的皮肤粘合以及敷料对皮肤的附加固定。
本公开提供了一种伤口敷料。该伤口敷料可包括具有第一主表面、第二主表面和背衬层周边的湿气可透过的背衬层;粘附到背衬层的第二主表面的至少一部分的吸收性亲水粘合剂,该吸收性亲水粘合剂包括吸收性亲水粘合剂周边;设置在吸收性亲水粘合剂中的抗菌剂;具有第一侧、第二侧和多孔层周边的多孔层,第一侧粘附到吸收性亲水粘合剂;以及粘附到多孔层的第二侧的第二疏水粘合剂。吸收性亲水粘合剂周边的100%可与背衬层重叠。多孔层周边可与吸收性亲水粘合剂至少50%重叠。
在伤口敷料的任何实施方案中,吸收性亲水粘合剂的厚度可为约0.2mm至约4.0mm。在任何上述实施方案中,吸收性亲水粘合剂可包含少于40%(w/w)的水。在任何上述实施方案中,敷料还可包括设置在多孔层的第二侧与第二疏水粘合剂之间的穿孔层。在任何上述实施方案中,在24℃在1弧度/秒的剪切下,吸收性亲水粘合剂的剪切模量可介于约5,000帕斯卡和约50,000帕斯卡之间。在任何上述实施方案中,在24℃在1弧度/秒的剪切下,吸收性亲水粘合剂的损耗剪切模量可介于约2,000帕斯卡和约20,000帕斯卡之间。
术语“包括”及其变型形式在说明书和权利要求中出现这些术语的地方不具有限制性含义。
如本文所用,“一个(种)”、“所述(该)”、“至少一个(种)”以及“一个(种)或多个(种)”可互换使用。因此,例如,多孔层可理解为“一个或多个”多孔层。
术语“和/或”意指所列要素的一个或全部,或所列要素的任何两个或更多个的组合。
另外,在本文中,通过端点表述的数值范围包括该范围内包含的所有数值(例如,1至5包括1、1.5、2、2.75、3、3.80、4、5等)。
本发明的上述发明内容并非旨在描述本发明的每个公开的实施方案或每种实施方式。以下描述更具体地举例说明示例性实施方案。在本专利申请全文的若干处,通过实施例列表提供了指导,这些实施例可以各种组合使用。在每种情况下,引用的列表仅用作代表性的组,而不应理解为排他性列表。
这些及其他实施方案的附加细节在下文附图和描述中示出。通过具体实施方式、附图和权利要求书,其它特征、对象和优点将变得显而易见。
附图说明
图1是根据本公开的具有任选穿孔层的伤口敷料的一个实施方案的示意性平面图。
图2是图1的伤口敷料的分解侧视图。
图3是图1中的伤口敷料的侧视图。
图4A和图4B是根据本公开的伤口敷料的替代实施方案的示意性平面图,其中吸收性亲水粘合剂周边不与多孔层周边的100%重叠。
具体实施方式
在详细解释本公开的任何实施方案之前,应当了解,本发明在其应用中不限于下文描述中所提及或下文附图中所示出的构造细节和部件布置方式。本发明能够具有其他实施方案,并且能够通过各种方式实践或进行。另外,应当理解,本文使用的措词和术语是用于说明目的而不应被视为限制性的。本文使用的“包括”、“包含”或“具有”及其变型形式意在涵盖其后列出的项目及其等同形式以及附加的项目。除非另外说明或限定,否则术语“连接”和“联接”及其变型形式均按广义使用,并且涵盖直接和间接这两方面的连接和联接。此外,“连接”和“联接”不限于物理或机械连接或联接。应当理解,在不偏离本公开范围的情况下,可采用其他实施方案并且可进行结构变化或逻辑变化。此外,术语诸如“前面”“后面”“顶部”“底部”等仅用于描述与另一个元件相关的元件,但绝非意图说明装置的具体方位,表明或暗示装置必需或需要的方位,或指定在应用中如何使用、安装、展示或放置本文所述的发明。
本公开整体涉及伤口敷料,该伤口敷料可留在伤口部位以在伤口部位长时间(例如,最多5天、最多7天)处理流体积聚。此外,敷料的构造(例如,具有设置在吸收性亲水粘合剂中的抗菌剂,和设置在伤口部位处的吸收性亲水粘合剂之间的多孔层)在伤口周围皮肤界面处提供即时的、相对高浓度的抗菌剂,并且其在伤口部位处提供相对较低浓度的抗菌剂。构成敷料的材料提供了有利于伤口敷料与解剖结构的一致性的伤口接触表面。
现在转到附图,图1是根据本公开的伤口敷料100的一个实施方案的平面视图、图2是其分解侧视图,并且图3是其侧视图。敷料100包括背衬层10、粘附到湿气可透过的背衬层10的至少一部分的吸收性亲水粘合剂30,和多孔层40。在任何实施方案中,敷料100任选地包括穿孔层50。伤口敷料100可以各种形状形成,包括例如圆形、椭圆形、梯形、矩形和正方形,其对于各种形状中的每种可包括圆角。
背衬层10具有第一主表面12、与第一主表面相背对的第二主表面14、以及限定背衬层边缘的背衬层周边16。背衬层10由顺应性足以与皮肤表面的解剖轮廓相符的柔性材料(例如,聚合物弹性膜、弹性非织造织物或它们的组合)制成。背衬层周边16限定背衬层10的外边缘。
背衬层10包括液体不可透过、湿蒸汽可渗透的聚合物膜,但其可包括各种其他材料,这些材料优选地与液体不可透过、湿蒸汽可渗透的聚合物膜组合使用。液体不可透过、湿蒸汽可渗透的聚合物膜可为适形的有机聚合物材料。在本文中,“适形”膜是适形于表面,甚至在表面运动(正如身体部分的表面)时仍适形于表面的那些膜。合适的膜具有允许湿汽穿过它们的组成和厚度。该膜帮助调节敷料下方伤口区域的水汽损失。该膜也用于屏蔽细菌和液态水或其他液体。
背衬层10的湿蒸汽可渗透的聚合物膜可具有宽泛的厚度范围。优选地,它们为从约10微米或12微米至75微米或250微米厚。此外,它们可包括设计为具有所需特性的一个或多个层。例如,这些层可与粘合剂层共挤出和/或粘结在一起,只要符合本文所述的膜和制品的整体性质即可。在任何实施方案中,背衬层10的厚度是约15μm至约250μm之间。
用于背衬层10的用于液体不可透过、湿蒸汽可渗透的聚合物膜的合适材料的示例包括合成有机聚合物,所述合成有机聚合物包括但不限于:可以商品名ESTANE(包括ESTANE58237和ESTANE 80MVT)从美国俄亥俄州威克利夫的路博润公司(Lubrizol,Wickliffe,Ohio)商购获得的聚氨酯;可以商品名PEBAX(包括PEBAX MV1074)从美国宾夕法尼亚州费城的埃尔夫阿托化学公司(Elf Atochem,Philadelphia,Pa.)商购获得的聚酰胺嵌段共聚物;可以商品名HYTREL从美国特拉华州威明顿的杜邦公司(DuPont,Wilmington,Del.)商购获得的聚酯嵌段共聚物。聚合物膜可由聚合物的一种或多种单体(例如,共聚物)或混合物(例如,共混物)制成。一种示例材料是热塑性聚合物(例如,当暴露于热时软化并且当冷却时恢复它们初始状态的那些),诸如热塑性聚氨酯。
本发明的伤口敷料的背衬层10可为其他可透气材料,包括例如非织造材料、织造材料和针织幅材、多孔膜(例如,通过穿孔或微孔结构提供),或其他已知背衬。一种所述非织造幅材为经熔融处理的聚氨酯(诸如可以商品名MORTHANE PS-440得自美国新罕布什尔州锡布鲁克的莫顿国际公司(Morton International,Seabrook,N.H.)的那些),或水刺非织造材料聚酯或人造丝聚酯幅材(诸如可以商品名SONTARA 8010或SONTARA 8411得自美国特拉华州威明顿的杜邦公司(DuPont,Wilmington,Del.)的那些)。其他合适的可透气背衬是开孔膜,诸如膜(得自美国特拉华州米德尔敦的DeltStar技术公司(DeltStarTechnologies,Middletown,DE))。
背衬层10可为液体不可透过、湿蒸汽可渗透的聚合物膜与湿蒸汽可渗透的非织造材料、织造材料或针织幅材,或多孔膜的组合,该组合除了别的优点以外可赋予敷料增强的结构完整性和改善的美观性。背衬中的层优选利用粘合剂层粘结在一起,所述粘合剂层例如可为连续或不连续的(例如诸如具有按照图案涂布的粘合剂层制备的),但是可使用其它粘结手段,包括热机械粘结,诸如热粘结或超声焊接。
第一粘合剂20粘附到(例如,涂覆到)至少一部分(例如,沿着靠近整个背衬层周边16的第二主表面14延伸的连续部分)。在使用中,第一粘合剂20在背衬层10与施用敷料的皮肤之间形成密封(例如,围绕整个背衬层周边16的液体密封)。
优选地,背衬层/第一粘合剂复合物应当允许湿蒸汽以等于或大于人体皮肤的速率透过。优选地,根据EN-13726-1:2002第3.3部分进行测量,未涂覆的膜(即,其上未涂覆第一粘合剂的背衬层)以至少10g/10cm2/24h的速率透过湿蒸汽。甚至更优选地,未涂覆的背衬层以大于20g/10cm2/24h的速率透过湿气。在任何实施方案中,背衬层的被粘合剂涂覆的部分以至少0.8g/10cm2/24h,并且优选地大于1.6g/10cm2/24h的速率透过湿蒸汽。
背衬层10优选地适形于解剖表面。因此,当将背衬层施加到解剖表面上时,即使当该表面移动时它也适形于该表面。优选的背衬层10也适形于动物的解剖关节。当该关节弯曲并随后返回到其未弯曲位置时,该背衬层拉伸以适应该关节的弯曲,但其具有足够的回弹力以当该关节返回到其未弯曲状态时继续适形于该关节。优选地,背衬层具有大于200%的极限伸长率。更优选地,背衬层具有大于400%的极限伸长率。
在公布的美国专利号5,088,483和号5,160,315中可找到优选用于本公开的伤口敷料的背衬层的该特性的描述,所述专利的公开内容据此全文以引用方式并入。特别优选的背衬层是弹性体聚氨酯、共聚酯或聚醚嵌段酰胺膜。这些膜结合了存在于优选背衬层中的回弹性、高湿蒸汽渗透性和透明性的理想性能。
第一粘合剂通常为压敏粘合剂,并特别是可施用到皮肤上的粘合剂,诸如美国专利号RE 24,906所述的丙烯酸酯共聚物(该专利的公开内容据此全文以引用方式并入);特别是97:3的丙烯酸异辛酯:丙烯酰胺共聚物。另一种合适的第一粘合剂为70:15:15的丙烯酸异辛酯:环氧乙烷丙烯酸酯:丙烯酸三元共聚物,如美国专利号4,737,410(实施例31)所述,该专利的公开内容据此以引用方式并入。其他可用的第一粘合剂在美国专利号3,389,827、4,112,213、4,310,509和4,323,557中有所描述,所述专利的公开内容据此全文以引用方式并入。
还可以设想到在第一粘合剂中添加药剂或抗菌剂,如美国专利号4,310,509和号4,323,557所述,这两个专利据此全文以引用方式并入。也可使用有机硅或聚氨酯粘合剂。合适的有机硅粘合剂公开于PCT公布号WO2010/056541和号WO2010/056543中,所述专利的公开内容以引用方式并入本文中。其他合适的有机硅粘合剂弹性体公开于美国专利号6479724中。
根据本公开,通常背衬上的第一粘合剂是不连续的,以便实现通过粘合剂/背衬层的高湿蒸汽透过率。可通过如美国专利号4,595,001和美国专利申请公布号2008-0233348所述的图案涂层或者通过从粘合剂中切出孔或大孔并层合至背衬的转换步骤实现不连续的粘合剂。涂覆第一粘合剂的背衬层能够以大于或等于人体皮肤速率的速率透过湿蒸汽。实现连续的粘合剂涂层的高湿蒸汽透过率的其他方式在美国专利号8,546,637中有所描述,该专利全文以引用方式并入本文中。
用于上述第一粘合剂20的优选压敏粘合剂优选地以大于或等于人体皮肤速率的速率透过湿蒸汽。虽然可以通过选择适当的粘合剂或通过使用非织造(例如,熔喷)粘合剂(如美国专利号6,171,985、美国专利号6,368,687和PCT公布号WO 99/27975所述,这些专利的全部内容全文以引用方式并入本文中)实现这样的特性,也可以设想在本公开的伤口敷料中可使用实现高湿蒸汽透过相对速率的其他方法,诸如对背衬层上的第一粘合剂进行图案涂覆(未示出)。另外,当在37摄氏度下的等渗盐水中浸没24小时时,该粘合剂具有低吸收性(即,小于其干重的15%,并且优选地小于其干重的5%)。
吸收性亲水粘合剂30粘附到背衬层10的第二主表面14的至少一部分上。吸收性亲水粘合剂30包括限定吸收性亲水粘合剂外边缘的吸收性亲水粘合剂周边36。吸收性亲水粘合剂周边36与背衬层周边16间隔开。因此,在使用中,当将背衬层10的第一粘合剂20施加到处理表面(未示出)时,背衬层10与吸收性亲水粘合剂周边36的100%重叠。如本文所用,如果第一片(例如,背衬层)覆盖第二片(例如,吸收性亲水粘合剂)的一部分或某个第三片的一部分(沿着其相对侧被第二片覆盖),则该第一片可以说是与第二片“重叠”或“叠置”。换句话讲,尽管由第三片隔开,但一片可与另一片“重叠”或“叠置”。
吸收性亲水粘合剂30可相对较薄。在任何实施方案中,吸收性亲水粘合剂的厚度是约0.2mm至约4.0mm。在任何实施方案中,吸收性亲水粘合剂的厚度是约0.4mm至约3mm。优选地,吸收性亲水粘合剂30的厚度大于0.50mm,并且更优选地大于1.0mm。吸收性亲水粘合剂30含有少于45%的水(w/w),并且优选地少于25%的水。当在37摄氏度下暴露于等渗盐水24小时时,该粘合剂可吸收其干重的至少1.0倍。吸收性亲水粘合剂30也应是柔性的,并且在干燥时具有高完整性。吸收性亲水粘合剂30在吸收湿气时会溶胀,但其不溶于水或等渗盐水。可用的吸收性亲水粘合剂的示例是美国专利公布号2009/0187130中所述的凝胶粘合剂。优选地,吸收性亲水粘合剂层应粘附到多孔层并且在其上延伸,并且其应延伸到多孔层周边的70%以外。
吸收性亲水粘合剂30能够吸收并保持具有与血液相似的离子强度的水性液体。因此,通过量化生理盐水的吸光度可容易地测试该特性。在任何实施方案中,吸收性亲水粘合剂能够吸收其干重的至少0.4倍;优选地,其干重的至少1.0倍;更优选地,大于或等于其干重的1.5倍;甚至更优选地,当与等渗盐水溶液在37℃下接触24小时时,大于或等于其干重的4倍。吸收性亲水粘合剂也具有高保湿性,因为当利用40mm汞柱的压力从外部压缩该粘合剂时,该粘合剂将保持大于其吸收能力的50%(即,残余吸收能力)。
在任何实施方案中,吸收性亲水粘合剂30可包含聚甘油-3、交联的聚乙烯基吡咯烷酮和/或羟丙基瓜尔胶。合适的吸收性亲水粘合剂的非限制性示例和制备所述吸收性亲水粘合剂的方法在国际公布号WO 2009/091682中有所描述,该专利全文以引用方式并入。吸收性亲水粘合剂包含抗菌剂,诸如例如双胍类抗菌剂(例如,葡萄糖酸氯己定)。
合适的吸收性亲水粘合剂组合物包括例如天然水凝胶,诸如果胶、明胶或羧甲基纤维素(CMC)(美国特拉华州威明顿的亚跨龙公司(Aqualon Corp.,Wilmington,Del.));半合成水凝胶,诸如交联的羧甲基纤维素X4ink CMC(例如,Ac-Di-Sol;美国宾夕法尼亚州费城的富曼实公司(FMC Corp.,Philadelphia,Pa.));合成水凝胶,诸如交联的聚丙烯酸(PAA)(例如,CARBOPOLTM号974P;美国俄亥俄州布雷克斯维尔的古德里奇公司(B.F.Goodrich,Brecksville,Ohio)),或它们的组合。
在大多数实施方案中,吸收性亲水粘合剂包括可溶胀的交联的聚(N-乙烯基内酰胺)、溶胀剂和改性聚合物,它们以足以形成如国际公布号WO 2004/108854中进一步描述的内聚压敏粘合剂组合物的量存在,所述专利全文以引用方式并入本文中。与交联的可溶胀的聚(N-乙烯基内酰胺)混合的溶胀剂的量可在组合物的约50重量%至约90重量%的范围内。因此,除了要添加到组合物中的任何生物相容性和/或治疗性和/或离子导电性材料之外,可溶胀的聚(N-乙烯基内酰胺)的重量百分比可为约10重量%至约50重量%。当聚(N-乙烯基内酰胺)为聚(N-乙烯基吡咯烷酮)时,聚(N-乙烯基吡咯烷酮)的重量百分比可在约15%至约45%的范围内。在特定实施方案中,聚(N-乙烯基吡咯烷酮)可在约18%至约35%的范围内。
在大多数实施方案中,本发明的吸收性亲水粘合剂组合物包含可溶胀的聚(N-乙烯基内酰胺),其通常在内酰胺处于固体形式时被辐射交联。在其他实施方案中,聚(N-乙烯基)内酰胺通过自由基聚合而在前体的本体或溶液中交联,所述前体包含N-乙烯基内酰胺单体,任选地其他单体以及如美国专利号4,931,282所述的交联化合物,该专利全文以引用方式并入本文中。可用于本公开的吸收性亲水粘合剂中的聚(N-乙烯基内酰胺)可以易于被交联的任何形式提供,诸如美国专利号4,931,282、5,225,473和5,389,376所述的固体形式,所述专利全文以引用方式并入本文中。通常,聚(N-乙烯基内酰胺)为N-乙烯基-2-吡咯烷酮的均聚物。
在暴露于电离辐射后,聚(N-乙烯基内酰胺)在水中的溶胀能力可为至少约15,通常至少约30,并且通常至少约40,如美国专利号5,409,966所述,该专利全文以引用方式并入本文中。任何固体形式的聚(N-乙烯基内酰胺)在经受来自高能量源的电离辐射时可交联以供使用。
改性聚合物存在于吸收性亲水粘合剂组合物中,以保持和/或增加内聚性,同时降低粘合性。当加入溶胀剂时,改性聚合物将溶解或悬浮在溶胀剂中。通常,当以1:9的改性聚合物对溶胀剂的比例将改性聚合物与溶胀剂混合时,改性聚合物将形成粘稠溶液或粘稠水凝胶。
溶胀剂的选择通常将确定适当的改性聚合物以实现粘附性的降低,同时保持或改善粘合剂组合物的内聚力。难溶于一种溶胀剂中的改性聚合物可在用于本发明的不同溶胀剂中高度溶胀。在一些实施方案中,合适的改性可溶胀聚合物的示例包括但不限于多糖、多糖衍生物、丙烯酸酯、丙烯酸酯衍生物、纤维素、纤维素衍生物以及它们的组合。
在特定实施方案中,用于本发明的改性可溶胀聚合物为羟丙基瓜尔胶、瓜尔胶、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、与三烷基铵取代的环氧化物反应的羟乙基纤维素的聚合季铵盐、羟乙基纤维素和二烯丙基二甲基氯化铵的共聚物,以及上述的衍生物及它们的组合。
改性聚合物的量可在组合物的最多约50重量%的范围内。因此,除了要添加到组合物中的任何生物相容性和/或治疗性的和/或离子导电性材料之外,改性聚合物的重量百分比可为约0.1重量%至约40重量%。当改性聚合物为羟丙基瓜尔胶时,羟丙基瓜尔胶的重量百分比可在约1%至约20%的范围内。
吸收性亲水粘合剂组合物还包含溶胀剂,该溶胀剂可溶胀交联的聚(N-乙烯基内酰胺)聚合物和改性聚合物并且与人体皮肤生物相容。可用于溶胀聚(N-乙烯基内酰胺)的溶胀剂的非限制性示例包括一元醇(例如,乙醇和异丙醇)、多元醇(例如,乙二醇、丙二醇、聚乙二醇(分子量在200和600之间)和甘油)、醚醇(例如,二醇醚)、不引起皮肤刺激或毒性反应的其他多元醇溶胀剂,和水。
根据吸收性亲水粘合剂组合物所需的最终用途,可使用非挥发性和/或挥发性溶胀剂。一种合适的溶胀剂可包含挥发性溶胀剂和非挥发性溶胀剂,诸如甘油或聚乙二醇与水的混合物。在一些实施方案中,非挥发性溶胀剂可单独使用,诸如例如甘油或聚乙二醇。同样,挥发性溶胀剂诸如水可在本发明的组合物中单独使用。对于本公开,“基本上不挥发”是指本公开中所使用的溶胀剂将使粘合剂聚合物诸如辐射的聚(N-乙烯基内酰胺)、充分内聚的压敏粘合剂,使得在暴露于加工或储存条件之后,小于给定体积的非挥发性溶胀剂的百分之十(10%)蒸发。
溶胀剂可以吸收性亲水粘合剂组合物的约50重量%至约90重量%范围内的量、并优选地约60重量%至约80重量%范围内的量添加。在一些实施方案中,甘油和聚乙二醇被选择作为基本上不挥发的溶胀剂。甘油和聚乙二醇可占溶胀剂的最多100重量%。
吸收性亲水粘合剂30可用于包含多种物质,任选地包含抗菌剂、用于透皮给药的药物、用于监控患者激素或其他物质的化学指示剂等。
吸收性亲水粘合剂可便于将抗菌剂递送到皮肤,减少感染经皮器械的可能性,或者治疗皮肤或伤口的感染。在大多数实施方案中,抗菌剂以总组合物的最多10重量%的水平添加到吸收性亲水粘合剂中。
存在许多生物活性材料,包括可设置在吸收性亲水粘合剂中的抗菌剂。抗菌剂的示例包括对氯间二甲苯酚、三氯生、氯己定及其盐诸如葡萄糖酸氯己定、聚六亚甲基双胍及其盐诸如聚六亚甲基双胍胺氯、碘、碘伏、脂肪酸单酯、聚-n-乙烯基吡咯烷酮碘伏、氧化银、银及其盐、过氧化物(例如,过氧化氢)、抗生素(例如,新霉素、杆菌肽和多粘菌素B)。其他合适的抗菌剂为国际公布号WO 2004/108854中所列出的那些。
制备本公开的吸收性亲水粘合剂组合物的方法包括将交联的聚(N-乙烯基内酰胺)与溶胀剂和改性聚合物以及溶剂中的其他添加剂(其在环境温度下或高于环境温度的温度下可挥发或稍微挥发)混合。通常,溶胀剂、改性聚合物和其他添加剂诸如抗菌剂为基本上未经辐射的形态。合适的挥发性溶剂的示例包括水、乙醇、甲醇和异丙醇。然后将一定量的所得悬浮液浇铸到基材诸如剥离衬件或背衬材料的表面上,然后储存。挥发性溶剂通过加热诸如通过施加微波能量、红外能量,或通过对流空气流等而蒸发,以便在基材上形成内聚的压敏粘合剂组合物。通常,加热至约65℃的干燥烘箱可用于蒸发步骤。产品剥离衬件可任选地层合到组合物的暴露表面上方,以保护其免受污染。
在任何实施方案中,吸收性亲水粘合剂30可包含水解胶体,该水解胶体含有聚异丁烯、基于聚异戊二烯的聚合物、可溶性吸收剂、不溶性吸收剂和增粘剂。合适的水解胶体组合物分别包括例如20重量%至40重量%的聚异丁烯(例如,来自美国新泽西州弗洛勒姆帕克的巴斯夫公司(BASF,Florham Park,NJ)的聚异丁烯)、15%至40%的基于聚异戊二烯的聚合物和15%至45%的可溶性和不溶性吸收剂诸如羧甲基纤维素(CMC)(美国特拉华州威明顿的亚跨龙公司(Aqualon Corp.,Wilmington,Del.))和交联的羧甲基纤维素X4ink CMC(例如,CMC;美国宾夕法尼亚州费城的富曼实公司(FMCCorp.,Philadelphia,Pa.)),以及不超过15重量%的增粘剂诸如95树脂(美国宾夕法尼亚州埃克斯顿的沙多玛公司(Sartomer Co.,Exton,PA))。
在一些实施方案中,水解胶体包含交联的疏水有机硅凝胶,其中分散有可溶性和/或不溶性吸收剂。吸收剂含量应为15重量%至45重量%。
除了能够吸收水性液体之外,当粘附到背衬层10时,本公开的吸收性亲水粘合剂30是湿气可透过的。因此,在任何实施方案中,根据EN-13726-1:2002第3.3部分进行测量,与吸收性亲水粘合剂30粘附的背衬层10的湿蒸汽透过率(MVTR)≥1g/10cm2/24h。优选地,该湿蒸汽透过率大于3g/10cm2/24h。有利的是,由于伤口敷料100具有湿蒸汽可透过的背衬层和湿蒸汽可透过的吸收性亲水粘合剂,因此湿气可通过穿过吸收性亲水粘合剂并离开完整的背衬层(处于蒸汽状态下)而被传输远离伤口部位并透过敷料100。通过吸收性亲水粘合剂和背衬层的高湿蒸汽透过率很重要,因为其允许对相对大量的伤口渗出物进行处理。
在任何实施方案中,在将本公开的伤口敷料施用到处理部位之前,吸收性亲水粘合剂包含少于40%(w/w)的水。在任何实施方案中,在将本公开的伤口敷料施用到处理部位之前,吸收性亲水粘合剂包含少于25%(w/w)的水。优选地,在将本公开的伤口敷料施用到处理部位之前,吸收性亲水粘合剂包含少于10%(w/w)的水。使用包含<40%(w/w)的水、<25%(w/w)的水或<10%(w/w)的水的吸收性亲水粘合剂减少了对特定封装的需求,原本需要该特定封装在使用前的储存期间保留吸收性亲水粘合剂中的水分。
吸收性亲水粘合剂的弹性(例如,通过储能模量(G’)表示)被选择为使得在吸收性亲水粘合剂的厚度范围内,伤口敷料是适形的,但具有高完整性,从而在拉伸时不会轻易脱落。在任何实施方案中,在将本公开的伤口敷料施用于处理部位之前,在24℃在1弧度/秒的剪切速率下,吸收性亲水粘合剂的储能剪切模量介于约5,000帕斯卡和约50,000帕斯卡之间。该储能剪切模量优选介于10,000帕斯卡和约30,000帕斯卡之间。
另外,损耗模量(G”)表示吸收性亲水粘合剂30的粘性响应。在任何实施方案中,在将本公开的伤口敷料施用于处理部位之前,在24℃在1弧度/秒的剪切下,吸收性亲水粘合剂的损耗剪切模量介于约2,000帕斯卡和约20,000帕斯卡(包括端值在内)之间。优选地,损耗模量G”介于约3,000帕斯卡和约15,000帕斯卡之间,包括端值在内。有利的是,在24℃在1弧度/秒的剪切下具有介于约2,000帕斯卡和约20,000帕斯卡之间的损耗模量G”的吸收性亲水粘合剂充分柔性以在皮肤上形成良好的密封,但不是太柔性以至于轻易流动且容易失去其完整性。
回到附图,根据本公开的伤口敷料100包括多孔层40。多孔层40具有第一侧42、第二侧44和多孔层周边46,该多孔层周边限定多孔层的外边缘,这进一步限定多孔层区域。多孔层40的第一侧42粘附到吸收性亲水粘合剂30。
在任何实施方案中,多孔层周边46的至少50%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的超过50%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少60%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少70%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少75%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少80%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少85%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少90%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的至少95%与吸收性亲水粘合剂30重叠。在任何实施方案中,多孔层周边46的100%与吸收性亲水粘合剂30重叠。优选地,吸收性亲水粘合剂30延伸超过多孔层周边46(即,朝向背衬层周边16)至少3mm,并且更优选地至少5mm。
除了为皮肤提供良好的密封之外,吸收性亲水粘合剂30还用作流体的贮存器,使得其从多孔层中吸收湿气,这样防止多孔层变得液体饱和。在多孔层中较少的液体可导致靠近伤口部位的皮肤较少的浸渍。
吸收性亲水粘合剂组合物可将抗菌剂递送到皮肤,减少感染经皮器械的可能性,或者治疗皮肤或伤口的感染。在大多数实施方案中,抗菌剂以总组合物的最多10重量%的水平添加。
存在许多生物活性材料,其包括抗菌剂。抗菌剂的示例包括对氯间二甲苯酚、三氯生、氯己定及其盐诸如葡萄糖酸氯己定、聚六亚甲基双胍及其盐诸如聚六亚甲基双胍胺氯、碘、碘伏、脂肪酸单酯、聚-n-乙烯基吡咯烷酮碘伏、氧化银、银及其盐、过氧化物(例如,过氧化氢)、抗生素(例如,新霉素、杆菌肽和多粘菌素B)。其他合适的抗菌剂为国际公布号WO2004/108854中所列出的那些。
多孔层40被构造成便于流体穿过多孔层到达吸收性亲水粘合剂30(例如,血液或者其他流体从伤口部位诸如切口泄漏出来)。在任何实施方案中,多孔层40可包括开孔泡沫、织造织物(例如,纱布)或非织造织物。多层多孔聚合物膜也将是可接受的。
多孔层40的另外目的是增加抗菌剂从吸收性亲水粘合剂扩散到开放性伤口的扩散通道,并且因此降低可到达伤口表面的抗菌剂的浓度。多孔层40优选地由开孔泡沫、非织造或织造材料构成。多孔层也可为穿孔或微孔膜多孔膜。对于开孔泡沫,其密度应小于0.2g/cm3,并且厚度应小于8mm。对于织造或非织造,非织造或织造材料的基重应小于500g/m2。多孔层40可由不同的层诸如层合到非织造材料的多孔膜构成。
在任何实施方案中,多孔层40可为材料层的组合。例如,层合(或者以其他方式附接)到泡沫的非织造织物可被认为是多孔层。在一个优选实施方案中,具有层合到其一侧或两侧上的多孔膜(大孔的或微孔的)然后层合到开孔泡沫上的非织造织物可用作良好的多孔层,因为多层使流体能够轻易穿过多孔层。
在任何实施方案中,根据本公开的伤口敷料还可包含第二疏水粘合剂(例如,包含如国际公布号WO 2015/134249所述的柔性有机硅凝胶粘合剂或柔性丙烯酸酯凝胶粘合剂,该专利全文以引用方式并入本文中),其直接粘附到多孔层的第二侧。任选地,穿孔层可设置在多孔层的第二侧与第二疏水粘合剂之间。穿孔层可包括穿孔膜,该穿孔膜在其面向伤口一侧上具有第二疏水粘合剂并且在面向多孔层40的侧面上具有丙烯酸酯粘合剂。此类穿孔膜的非限制性示例在美国专利申请公布号2010/0159192中有所描述,该专利全文以引用方式并入本文中。
在任何实施方案中,本公开的伤口敷料100任选地包括穿孔层50。穿孔层50包括具有第一表面52、第二表面53和延伸穿过其中的多个穿孔54的基材51(例如,聚合物膜基材、泡沫、非织造织物、织造织物或者任何两种或更多种前述材料的组合)。穿孔54提供用于来自伤口的渗出物的穿过基材51并进入多孔层40中的液体通道。
穿孔层50的第一表面52经由穿孔层附着粘合剂58粘附到多孔层40的第二侧44,该穿孔层附着粘合剂可涂覆在穿孔层50上。第二粘合剂可为将穿孔层50粘附到多孔层40上的任何合适粘合剂。任选地,穿孔层50可包含涂覆在其上的第二疏水粘合剂56。第二疏水粘合剂56可提供伤口敷料100与处理部位(皮肤)的附加固定。在任何实施方案中,第二疏水粘合剂56可包含疏水性柔性有机硅粘合剂或柔性丙烯酸酯凝胶粘合剂。穿孔层附着粘合剂58和第二疏水粘合剂56可在对基材进行穿孔之前涂覆到穿孔层50上,因此第二粘合剂和第三粘合剂也包括穿孔。另选地或除此之外,穿孔层附着粘合剂58和第二疏水粘合剂56可图案化地涂覆到基材51上。有利的是,穿孔层50中的穿孔54不仅提供用于湿气透过到多孔层40的通道,其还使穿孔层50与各种伤口部位的解剖表面高度适形。穿孔层不必与多孔层的周边同延。
优选地,第二疏水粘合剂56为柔性有机硅凝胶粘合剂或柔性丙烯酸酯凝胶粘合剂,并且大于50微米厚,更优选地大于75微米厚。第二疏水粘合剂56提供伤口敷料对组织和伤口周围皮肤的附加固定。它还会使液体离开伤口周围皮肤,因此有助于最小化伤口周围皮肤浸渍。优选地,具有柔性有机硅粘合剂层的该多孔层对钢的粘附力小于吸收性亲水粘合剂和/或涂覆在背衬上的粘合剂层对钢的粘附力。另外,在37摄氏度下的等渗盐水中浸没24小时后,第三粘合剂具有低吸收性(即,小于其干重的15%,并且优选地小于其干重的5%)。
尽管图1和图2示出的实施方案示出了伤口敷料100,其中吸收性亲水粘合剂周边36与多孔层周边46完全重叠,但可以设想,在某些实施方案中,吸收性亲水粘合剂周边36不与多孔层周边46的100%重叠,如上所述。图4A和图4B示出了伤口敷料的两个替代实施方案(分别为伤口敷料102和伤口敷料101),其中吸收性亲水粘合剂30的吸收性亲水粘合剂周边36与多孔层40的多孔层周边46不完全重叠。在这些实施方案中,背衬层10的背衬层周边16与吸收性亲水粘合剂周边36和多孔层周边46完全重叠。
在使用中,将伤口敷料施用到具有背衬层的(即,第二主表面的)面向皮肤的粘合剂侧的处理部位。
示例性实施方案
实施方案A为一种伤口敷料,所述伤口敷料包括:
湿气可透过的背衬层,该背衬层具有第一主表面、第二主表面和背衬层周边;
其中第二主表面具有设置在其上的靠近背衬层周边的第一疏水粘合剂;
吸收性亲水粘合剂,该吸收性亲水粘合剂粘附到背衬层的第二主表面的至少一部分,该吸收性亲水粘合剂包括吸收性亲水粘合剂周边;
抗菌剂,该抗菌剂设置在吸收性亲水粘合剂中;
多孔层,该多孔层具有第一侧、第二侧和多孔层周边,该第一侧粘附到吸收性亲水粘合剂;和
第二疏水粘合剂,该第二疏水粘合剂粘附到多孔层的第二侧;
其中吸收性亲水粘合剂周边的100%与背衬层重叠;
其中多孔层周边的至少50%与吸收性亲水粘合剂重叠。
实施方案B为根据实施方案A所述的伤口敷料,其中吸收性亲水粘合剂的厚度是约0.2mm至约4.0mm。
实施方案C为根据实施方案A或实施方案B所述的伤口敷料,其中吸收性亲水粘合剂包含少于40%(w/w)的水。
实施方案D为根据实施方案C所述的伤口敷料,其中吸收性亲水粘合剂包含少于25%(w/w)的水。
实施方案E为根据前述实施方案中的任一项所述的伤口敷料,其中敷料还包括设置在多孔层的第二侧与第二疏水粘合剂之间的穿孔层。
实施方案F为根据实施方案E所述的伤口敷料,其中穿孔层包括穿孔的聚合物基材。
实施方案G为根据前述实施方案中的任一项所述的伤口敷料,其中粘附到背衬层的吸收性亲水粘合剂对钢的粘附力大于粘附到多孔层的第二疏水粘合剂对钢的粘附力。
实施方案H为根据前述实施方案中的任一项所述的伤口敷料,其中粘附到背衬层的吸收性亲水粘合剂对钢的粘附力大于粘附到背衬层的所述第一疏水粘合剂对钢的粘附力。
实施方案I为根据前述实施方案中的任一项所述的伤口敷料,其中背衬层包括聚合物弹性膜、弹性非织造织物或它们的组合。
实施方案J为根据实施方案I所述的伤口敷料,其中背衬层为约15μm至约250μm厚。
实施方案K为根据前述实施方案中的任一项所述的伤口敷料,其中根据EN-13726-1:2002第3.3部分进行测量,背衬层的湿蒸汽透过率≥10g/10cm2/24h。
实施方案L为根据前述实施方案中的任一项所述的伤口敷料,其中根据EN-13726-1:2002第3.3部分进行测量,与吸收性亲水粘合剂粘附的背衬层的湿蒸汽透过率≥1g/10cm2/24h。
实施方案M为根据前述实施方案中的任一项所述的伤口敷料,其中在24℃在1弧度/秒的剪切下,吸收性亲水粘合剂的剪切模量介于约5,000帕斯卡和约50,000帕斯卡之间。
实施方案N为根据前述实施方案中的任一项所述的伤口敷料,其中在24℃在1弧度/秒的剪切下,吸收性亲水粘合剂的损耗剪切模量介于约2,000帕斯卡和约20,000帕斯卡之间。
实施方案O为根据前述实施方案中的任一项所述的伤口敷料,其中多孔吸收层包括开孔泡沫、织造织物、非织造织物、多孔膜或它们的组合。
实施方案P为根据前述实施方案中的任一项所述的伤口敷料,其中当与等渗盐水溶液在37℃下接触24小时时,吸收性亲水粘合剂能够吸收其干重的≥1.5倍。
实施例
通过下面的实施例进一步说明了本发明的目的和优势,但这些实施例中列举的具体材料和用量以及其他条件和细节不应解释为是对本发明不当的限制。除非另外指明,否则所有的份数和百分比都以重量计,所有的水都为蒸馏水并且所有的分子量都为重均分子量。
对钢的粘附力测试
通过光亮退火工艺使用304AISI不锈钢板进行对钢的粘附力测试。板的尺寸为51mm×127mm×1.6mm。在每次测试之前,使用经异丙醇饱和的一次性实验室擦拭物擦拭一次,并且使用经正庚烷饱和的一次性实验室擦拭物擦拭三次,以清洁测试表面。使表面干燥,然后将样品置于测试表面上。测试样品的长度为1”宽。在测量粘合力之前,将样品的粘合剂侧手动地压贴在钢板上,并且用辊子将样品的非粘合剂侧在每个方向上滚动一次以将粘合剂侧压贴在板上。辊的总直径为3.75"(95mm),表面宽度为1.75"(44mm),并且涂覆有约0.25"(6mm)厚、有效轧制重量为4.5磅或2043克、硬度计硬度为75至85的橡胶。轧制速度为约50毫米/秒。以305mm/min的速率使用180度剥离进行轧制后,立即测试样品。在25℃和50%相对湿度下的室内进行测试。
实施例1制备在一侧上涂覆有疏水粘合剂的背衬层。
使用23微米厚的58237热塑性聚氨酯膜(美国俄亥俄州威克利夫的路博润公司(Lubrizol Corporation,Wickliffe,OH))作为背衬层。将膜层合到具有750mg/200cm2涂层重量的不连续(具有10%总开口面积的直径约1mm的孔的图案)丙烯酸酯粘合剂层。将该膜粘合剂样品在25摄氏度和50%相对湿度下进行平衡。在4N/25mm下测量该样品对钢的粘附力值。
实施例2制备与吸收性亲水粘合剂粘附的背衬层。
如国际公布号WO 2009/091682的实施例3所述,制备1.75mm厚的吸收性亲水粘合剂。将吸收性亲水粘合剂的连续层层合到23微米厚的58237热塑性聚氨酯膜。将该膜粘合剂样品在25摄氏度和50%相对湿度下进行平衡。在5.8N/25mm下测量该样品对钢的粘附力值。
实施例3制备其上涂覆有疏水粘合剂的多孔层。
将30微米厚的聚氨酯膜(得自美国宾夕法尼亚州匹兹堡的拜耳公司(Bayer;Pittsburg,PA)的1209热塑性聚氨酯膜)挤出到涂层重量为550mg/200cm2的连续丙烯酸酯粘合剂上。然后将有机硅凝胶粘合剂以0.1mm厚涂覆并固化(如国际公布号WO 2010/056543所述,该专利全文以引用方式并入本文中)到聚氨酯膜/粘合剂层合物上。将保护性衬件放在该有机硅粘合剂上。然后将该多层层合物机械穿孔(1.5mm直径孔,20%开口)。然后将穿孔层合物的丙烯酸酯侧层合到由90642 3MTMTegadermTM泡沫有机硅边界敷料(得自美国明尼苏达州圣保罗的3M公司(3M Company;St.Paul,MN))切割出的聚氨酯泡沫。然后在25℃和50%相对湿度下在泡沫层合物平衡后,测试该泡沫层合物的有机硅侧对钢的粘附力。在2N/25mm下测量对钢的粘附力值。
实施例4本公开的吸收性亲水粘合剂凝胶的流变特性。
如国际公布号WO 2009/091682的实施例3所述,制备1.6mm厚的吸收性亲水粘合剂样品。使用TA Instruments'ARES流变仪(美国特拉华州纽卡斯尔的德州仪器公司(TexasInstruments,New Castle,DE))测量吸收性亲水粘合剂的流变特性随干燥温度和时间的变化。在48.9℃下干燥样品。在24℃下以0.1至500弧度/秒的频率范围进行剪切测量。粘合剂凝胶样品是直径为25mm、厚度为1.6mm的圆。动态剪切粘度的结果示于表1中。储能剪切模量(G’)和损耗剪切模量(G”)的结果示于表2中。
表1:在不同剪切速率下随干燥时间的粘度(泊)变化。
表2:随干燥时间和剪切速率的剪切模量(G’)和损耗剪切模量(G”)的变化。
本文引用的所有专利、专利申请和专利公开的全部公开内容以及可供使用的电子版材料均以引用方式并入。在本专利申请的公开内容和以引用方式并入本文的任何文献的一个或多个公开内容之间存在任何矛盾的情况下,应以本专利申请的公开内容为准。上述具体实施方式和实施例仅为清楚理解本发明而给出。所述具体实施方式和实施例不应被理解为不必要的限制。本发明不限于示出的和描述的具体细节,对本领域的技术人员而言显而易见的变型形式将包括在由权利要求书所限定的本发明中。
所有的标题是为了阅读者方便,而不应该用于限制该标题后面的正文的含义,除非如此规定。
本文说明性地描述的本发明可在不存在本文未具体公开的任何元件的情况下进行适当地实践。因此,例如,在本文的每个实例中,术语“包括”、“基本上由......组成”和“由......组成”中的任一个可被替换为其它两个术语中的任一个。尽管将已采用的术语和表达用作描述而非限制术语,并且非旨在使用此类术语和表达而排出所示和所描述的特征或其部分的任何等同物,但是已经认识到,在所要求保护的本发明的范围内的各种修改是可能的。因此,应当理解,尽管本发明已通过优选的实施方式和任选的特征而具体公开,但是本领域的技术人员可推出本文所公开的概念的修改和变型,并且此类修改和变型被视为在由所附的权利要求所限定的本发明的范围内。
Claims (16)
1.一种伤口敷料,所述伤口敷料包括:
湿气可透过的背衬层,所述背衬层具有第一主表面、第二主表面和背衬层周边;
其中所述第二主表面具有设置在其上的靠近所述背衬层周边的第一疏水粘合剂;
吸收性亲水粘合剂,所述吸收性亲水粘合剂粘附到所述背衬层的所述第二主表面的至少一部分,所述吸收性亲水粘合剂包括吸收性亲水粘合剂周边;
抗菌剂,所述抗菌剂设置在所述吸收性亲水粘合剂中;
多孔层,所述多孔层具有第一侧、第二侧和多孔层周边,所述第一侧粘附到所述吸收性亲水粘合剂;和
第二疏水粘合剂,所述第二疏水粘合剂粘附到所述多孔层的所述第二侧;
其中所述吸收性亲水粘合剂周边的100%与所述背衬层重叠;
其中所述多孔层周边的至少50%与所述吸收性亲水粘合剂重叠。
2.根据权利要求1所述的伤口敷料,其中所述吸收性亲水粘合剂的厚度是约0.2mm至约4.0mm。
3.根据权利要求1或权利要求2所述的伤口敷料,其中所述吸收性亲水粘合剂包含少于40%(w/w)的水。
4.根据权利要求3所述的伤口敷料,其中所述吸收性亲水粘合剂包含少于25%(w/w)的水。
5.根据前述权利要求中的任一项所述的伤口敷料,其中所述敷料还包括设置在所述多孔层的所述第二侧与所述第二疏水粘合剂之间的穿孔层。
6.根据权利要求5所述的伤口敷料,其中所述穿孔层包括穿孔的聚合物基材。
7.根据前述权利要求中的任一项所述的伤口敷料,其中粘附到所述背衬层的所述吸收性亲水粘合剂对钢的粘附力大于粘附到所述多孔层的所述第二疏水粘合剂对钢的粘附力。
8.根据前述权利要求中的任一项所述的伤口敷料,其中粘附到所述背衬层的所述吸收性亲水粘合剂对钢的粘附力大于粘附到所述背衬层的所述第一疏水粘合剂对钢的粘附力。
9.根据前述权利要求中的任一项所述的伤口敷料,其中所述背衬层包括聚合物弹性膜、弹性非织造织物或它们的组合。
10.根据权利要求9所述的伤口敷料,其中所述背衬层为约15μm至约250μm厚。
11.根据前述权利要求中的任一项所述的伤口敷料,其中根据EN-13726-1:2002第3.3部分进行测量,所述背衬层的湿蒸汽透过率≥10g/10cm2/24h。
12.根据前述权利要求中的任一项所述的伤口敷料,其中根据EN-13726-1:2002第3.3部分进行测量,与所述吸收性亲水粘合剂粘附的所述背衬层的湿蒸汽透过率≥1g/10cm2/24h。
13.根据前述权利要求中的任一项所述的伤口敷料,其中在24℃在1弧度/秒的剪切下,所述吸收性亲水粘合剂的剪切模量介于约5,000帕斯卡和约50,000帕斯卡之间。
14.根据前述权利要求中任一项的所述的伤口敷料,其中在24℃在1弧度/秒的剪切下,所述吸收性亲水粘合剂的损耗剪切模量介于约2,000帕斯卡和约20,000帕斯卡之间。
15.根据前述权利要求中的任一项所述的伤口敷料,其中所述多孔吸收层包括开孔泡沫、织造织物、非织造织物、多孔膜或它们的组合。
16.根据前述权利要求中的任一项所述的伤口敷料,其中当与等渗盐水溶液在37℃下接触24小时时,所述吸收性亲水粘合剂能够吸收其干重的≥1.5倍。
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CN114712088A (zh) * | 2022-04-01 | 2022-07-08 | 浙江隆腾医用新材料有限公司 | 一种羧甲基纤维素创面敷料 |
CN114712088B (zh) * | 2022-04-01 | 2023-05-16 | 浙江隆腾医用新材料有限公司 | 一种羧甲基纤维素创面敷料 |
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JP2018500137A (ja) | 2018-01-11 |
JP2018508243A (ja) | 2018-03-29 |
JP6744315B2 (ja) | 2020-08-19 |
WO2016109418A1 (en) | 2016-07-07 |
WO2016109420A1 (en) | 2016-07-07 |
US20200107967A1 (en) | 2020-04-09 |
EP3240581B1 (en) | 2020-04-15 |
US11007086B2 (en) | 2021-05-18 |
US20170367895A1 (en) | 2017-12-28 |
US10537478B2 (en) | 2020-01-21 |
EP3240580B1 (en) | 2020-04-15 |
CN107106334B (zh) | 2021-02-09 |
CN107106723B (zh) | 2020-10-23 |
CN107106723A (zh) | 2017-08-29 |
EP3240580A1 (en) | 2017-11-08 |
EP3240581A1 (en) | 2017-11-08 |
US20170367896A1 (en) | 2017-12-28 |
JP6838812B2 (ja) | 2021-03-03 |
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