CN109789038A - 用于皮肤闭合的方法和装置 - Google Patents
用于皮肤闭合的方法和装置 Download PDFInfo
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- CN109789038A CN109789038A CN201780060838.1A CN201780060838A CN109789038A CN 109789038 A CN109789038 A CN 109789038A CN 201780060838 A CN201780060838 A CN 201780060838A CN 109789038 A CN109789038 A CN 109789038A
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Abstract
本发明公开了一种伤口闭合装置及其使用方法。该伤口闭合装置包括伤口闭合条带和可拆离地粘附到粘合剂的非对称的两部分剥离衬垫组件,该伤口闭合条带包括面向伤口侧面和顶侧面,该面向伤口侧面包含施用在伤口闭合条带的面向伤口侧面的至少一部分上的粘合剂,该剥离衬垫组件包括第一区段和第二区段,其中第二区段包括形成突片的无伤口闭合条带的部分。在另选实施方案中,该装置是多分段的,并且伤口闭合条带可与剥离衬垫组件共延。
Description
本申请为2016年9月29日提交的美国专利申请第15/280303号的部分继续申请并要求该专利申请的权益。上述相关美国专利申请的全部公开内容以引用方式并入本文以用于各种目的。
背景技术
1.技术领域
本发明涉及用于伤口闭合的装置、系统和方法,特别是用于由撕裂或手术切口形成的伤口的皮肤闭合的的装置、系统和方法。
2.相关领域
伤口闭合带和局部粘合剂提供用钉和缝合线来闭合伤口的替代方式。与处理皮肤闭合时使用钉和缝合线相比,使用伤口闭合带或局部粘合剂以及其组合包括以下优点:较少组织创伤、改善的美容效果和较少疼痛。
US 2002/0193721公开了伤口闭合网格状带设备及其使用方法。参考US 2002/0193721的图10和该出版物的对应文本,示出如何使用该网格带来固定图9的伤口。具体地,出版物的第43段在如下部分中描述了三种重新形成的伤口闭合技巧:“密封伤口的第一示例性方法为将WCGT(“伤口闭合网格带”)100放置在伤口90的一侧面上,在数字92与93之间沿轴略微弯曲,使得另一侧面91在皮肤上方倾斜,从而将不粘附。将侧面90压入到位并且施加适当的压力后,用一只手拉拽WCGT,而另一只手(如果是自施用式或单手施用,则为该手的拇指)将另一侧面91上的皮肤推入到位,然后WCGT降低到合适位置。通过在粘合剂破坏不太重要的边缘处抓握WCGT,或者另选地通过让背面附接到第二侧面91而第一侧面90压入到位,可实现这种处理。第二示例性施用方法为向上弯曲WCGT,或沿所示较长轴向上将其保持在弯曲位置,并且将其定位在始于伤口92的一个端部处。然后,如先前那样,将伤口压在一起并且沿伤口的长度从一端92到另一端93逐步将WCGT压入到位。对于小伤口,第三种方法为在边缘处握住WCGT并通过预期WCGT区域外部的压力闭合伤口,然后同时将WCGT压入到位。”
在前面的描述中,接触伤口的粘合剂的破坏是公认的问题,因为需要握住WCGT100的底面的至少一些,尤其是当朝向伤口的侧面91拉动伤口的侧面90时。因此根据前面的描述,似乎伤口闭合带仅具有单个剥离衬垫。
US 2008/0302487 A1描述了被构造成用于与背胶网片和背衬膜一起操作来粘合组织的分配装置。该装置防止或消除了网片在施加到伤口部位之前的变形,并且包括用于减轻或消除使用过程中粘合的装置。所述分配装置构造为以“向前”方式操作(网片施加到其的基底在施加网片后从施用装置下面穿过),以便在使用过程中基本不受阻挡地观察创口部位。背衬膜是单个条带,该条带防止卷圈的背胶网片的粘合剂破坏和自粘附。
US 2005/0182443 A涉及组织粘合制品,其包括柔性材料、在柔性材料底面的至少一部分上施用的粘合剂物质、以及渗透穿过柔性材料的至少一部分的可聚合粘合剂组合物。尽管未在图中明确示出,但可使用合适的背衬或剥离材料来覆盖施用到柔性材料底面的粘合剂物质。此类背衬材料是本领域中熟知的用于覆盖粘合剂的材料,并且可包括例如纸、塑料等。
仍然需要使用外科带、局部粘合剂及其组合诸如本发明提供的那些的改进装置和系统。
附图说明
图1描绘根据本发明的实施方案的伤口闭合装置的顶视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图2描绘根据本发明的实施方案的伤口闭合装置(在移除剥离衬垫和施用到伤口之前)的面向伤口的视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图3至图6描绘根据本发明的实施方案的伤口闭合装置的边视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图7描绘使用根据本发明的装置的第一步骤。
图8描绘使用根据本发明的装置的第二步骤。
图9描绘使用根据本发明的装置的第三步骤。
图10描绘使用根据本发明的装置的第四步骤。
图11描绘使用根据本发明的装置的第五步骤。
图12描绘根据本发明的装置的另选实施方案,该装置包括若干个单独的伤口闭合装置的穿孔片段。
图13描绘根据本发明的实施方案的图12的伤口闭合装置(在移除剥离衬垫和施用到伤口之前)的底视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图14描绘根据本发明的实施方案的图12的伤口闭合装置的顶视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图15至图18描绘根据本发明的实施方案的图13和14的伤口闭合装置的边视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图19以根据本发明的实施方案的伤口闭合装置(在移除剥离衬垫和施用到伤口之前)的底视图描绘了本发明的另选实施方案,该伤口闭合装置包括非对称的两部分剥离衬垫。
图20描绘根据本发明的实施方案的图19的伤口闭合装置的顶视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图21至图24描绘根据本发明的实施方案的图19和图20中描绘的伤口闭合装置的边视图,该伤口闭合装置包括非对称的两部分剥离衬垫。
图25描绘使用根据本发明的装置的第一步骤。
图26描绘使用根据本发明的装置的第二步骤。
图27描绘使用根据本发明的装置的第三步骤。
图28描绘使用根据本发明的装置的第四步骤。
图29描绘使用根据本发明的装置的第五步骤。
图30描绘使用根据本发明的装置的第六步骤。
发明内容
本发明的一个方面涉及具有长度A、宽度B、上边缘、下边缘、右边缘和左边缘的伤口闭合装置,该伤口闭合装置包括:
伤口闭合条带,该伤口闭合条带具有长度A、宽度F、面向伤口侧面、顶侧面、上边缘和下边缘,该面向伤口侧面包含施用在面向伤口侧面的至少一部分上的粘合剂;
剥离衬垫组件,该剥离衬垫组件通过粘合剂可拆离地粘附到伤口闭合条带,该剥离衬垫组件由具有长度A和宽度E的第一区段和具有长度A和宽度D的第二区段组成;
其中剥离衬垫组件延伸伤口闭合装置的全长度A并且延伸伤口闭合装置的全宽度B,使得剥离衬垫组件形成无伤口闭合条带的突片,其中无伤口闭合条带的突片具有从伤口闭合装置的下边缘延伸到伤口闭合条带的下边缘的宽度G;
其中伤口闭合条带的宽度F比第一区段的宽度E大宽度H,其中H等于长度D减去长度G;并且
其中第一区段和第二区段通过衬垫切割部彼此分离。
在本发明的优选方面,
伤口闭合条带是多孔的;
长度A为2cm至20cm,并且宽度B为1.7cm至12cm;
伤口闭合条带具有从伤口闭合装置的上边缘延伸的宽度F,并且其中F为1.5cm至8cm;
无伤口闭合条带的突片具有0.2cm至4.0cm的宽度G;
剥离衬垫组件的第一区段具有从伤口闭合装置的上边缘延伸的1.5cm至8.0cm的宽度E,并且剥离衬垫组件的第二区段具有从伤口闭合装置的下边缘延伸的0.2cm至4cm的宽度D,使得第一区段的宽度E大于第二区段的宽度D;并且
装置的宽度B等于第一区段的宽度E加上第二区段的宽度D。
本发明的另外方面涉及闭合具有至少第一分离的局部组织表面和第二分离的局部组织表面的伤口的方法,该方法包括以下步骤:
a)利用本文所述的本发明的伤口闭合装置的实施方案中的任一个,该伤口闭合装置通常包括伤口闭合条带和可拆离地粘附到粘合剂的非对称的两部分剥离衬垫组件,该伤口闭合条带包括面向伤口侧面和顶侧面,该面向伤口侧面包含施用在面向伤口侧面的至少一部分上的粘合剂,该剥离衬垫组件包括第一区段和第二区段,其中第二区段包括形成突片的无伤口闭合条带的部分;
b)在抓握剥离衬垫组件的第二区段的突片的同时,移除剥离衬垫组件的第一区段,以暴露伤口闭合条带的面向伤口侧面的一部分;
c)将伤口闭合条带的暴露的面向伤口侧面的一部分粘附到至少第一分离的局部组织表面,并且朝向至少第二分离的局部组织表面牵拉剥离衬垫的第二区段的突片,以形成两个邻接的局部组织表面,并且将伤口闭合条带的暴露的面向伤口侧面进一步粘附到至少第二局部组织表面;以及
d)移除剥离衬垫组件的第二区段以进一步暴露伤口闭合条带的面向伤口侧面,并且将进一步暴露的伤口闭合条带粘附到第二局部组织表面。
用于本发明的方法的装置可以是本文公开的装置中的任一种。
期望地,该方法还包括在粘附的伤口闭合条带上施用可流动的可聚合粘合剂的步骤。
在另选实施方案中,本发明包括一种伤口闭合装置,该伤口闭合装置是多分段的并且包括若干个单独的伤口闭合装置。
本发明的优点包括:
1)最大程度减少粘合剂从产品到用户手指/手套的转移,从而最大化对组织的夹持。
2)由于存在剥离衬垫的第二区段,当部署在接近的伤口边缘之后便于重新定位伤口闭合条带。
3)粘合剂仅存在于旨在与组织接触的侧面上。因此不存在物体和不与组织接触的伤口闭合条带侧面的意外粘附。
4)由于第二剥离纸区段提供足够的刚性,因此在组织接近期间对于伤口闭合条带的操纵是稳定的。
具体实施方式
本发明的伤口闭合装置的改善的易用性的关键方面在于与伤口闭合条带—起使用的非对称的两部分剥离衬垫组件。
图1和图2分别描绘本发明的伤口闭合装置100的一个实施方案的顶视图和面向伤口的视图,该伤口闭合装置100具有上边缘1、下边缘2、右边缘3和左边缘4。参照图1和图2,具有长度A和宽度B的伤口闭合装置100包括具有长度A、宽度F和下缘6的伤口闭合条带110;和剥离衬垫组件140,该剥离衬垫组件140具有切割部5并且由具有长度A和宽度E的第一区段120和具有长度A和宽度D的第二区段130组成。应当指出的是,尺寸C表示第一区段120延伸超过伤口闭合装置100的中线的宽度;尺寸H表示伤口闭合条带110与第二区段130的重叠;并且尺寸G表示第二区段130的部分7,该部分7无伤口闭合条带110,并且可用于夹持装置100而不必接触伤口闭合条带110的含粘合剂的伤口接触侧面。
图3、图4、图5和图6分别提供装置100的上边缘视图、下边缘视图、左侧边缘视图和右侧边缘视图。
伤口闭合装置100的典型和优选尺寸为:
尺寸 | 典型的(cm) | 最优选的(cm) |
A | 2.0-20.0 | 12.0 |
B | 1.0-14 | 4.5 |
C | >0.0 | 1.0 |
D | 0.5-4.0 | 1.5 |
E | 0.6-10.0 | 3.0 |
F | 1.0-8.0 | 3.5 |
G | 0.2-4.0 | 1.0 |
H | 0.2-2 | 0.5 |
关于以上指出的各种尺寸,本领域技术人员将认识到,本发明的伤口闭合装置的其它尺寸是可能的,这取决于本领域技术人员可选择并调适以处理各种大小和形状的伤口或切口的具体尺寸。另外,例如参照图1,设想伤口闭合条带110周边p不需要与装置100周边p'的部分共延,并且可部分地共延或完全不共延,这取决于伤口闭合条带110和剥离衬垫组件140之间的边沿是否为期望的。
一般来讲,装置100可具有允许用户有效地施用以闭合伤口或切口的任何长度A和宽度B。对于许多应用,长度A通常将在约2cm至约20cm、优选约10cm至约15cm的范围内,并且最优选为约12cm。宽度B通常将在约1.0cm至约14cm、优选约2cm至约10cm的范围内,并且最优选为约4.5cm。
另外,伤口闭合条带110可具有允许用户有效地施用以闭合伤口或切口的任何长度A和宽度F。对于许多应用,长度A通常将在约2cm至约20cm、优选约10cm至约15cm的范围内,并且最优选为约12cm。宽度F通常将在约1.0cm至约8cm、优选约2cm至约6cm的范围内,并且最优选为约3.5cm。
尺寸C是伤口闭合装置100的中线与第一区段120和第二区段130之间的剥离衬垫切割部5之间的距离。尺寸C使得剥离组件成为非对称的两部分组件。如果尺寸C等于0cm,则剥离组件将不再是非对称的,因为那时剥离组件切割部5将在中线处,并且因此第一剥离区段120和第二剥离区段130将具有相等的宽度。因此,尺寸C应大于0,并且在0.1cm至约2cm、优选约0.5cm至约1.5cm的范围内,并且最优选为约1.0cm。
尺寸D在0.5cm至约4cm、优选约0.7cm至约3cm的范围内,并且最优选为约1.5cm。在上述范围内,通过伤口闭合条带110和第二区段130的充分重叠来便利地操控装置100,以充分地实现伤口的分离的局部组织表面的接近。
尺寸E是第一区段120的宽度,并且与伤口闭合条带110的宽度的相关,伤口闭合条带110的该宽度适于用户定位和/或重新定位伤口闭合条带110,用于伤口的分离的局部组织表面的初始接近。尺寸E在0.6cm至约10cm、优选约2.0cm至约5cm的范围内,并且最优选为约3.0cm。在上述范围内,伤口闭合条带110充分地使大小在1cm至约20cm的范围内的伤口接近并覆盖该伤口。
尺寸G在0.2cm至约4cm、优选约0.5cm至约3cm的范围内,并且最优选为约1.0cm。在上述范围内,便利地操控装置100,而不破坏伤口闭合条带110的面向伤口侧面的压敏粘合剂。
尺寸H在0.2cm至约2.0cm、优选约0.3cm至约1.0cm的范围内,并且最优选为约0.5cm。在上述范围内,通过第二区段130充分粘附到伤口闭合条带110来便利地操控装置100,以实现伤口的接近。
对于处理约1.0cm至约12cm的手术伤口切口,装置100的优选实施方案的总长度A为约12cm并且总宽度B为约4.5cm,伤口闭合条带110的总长度A为约12cm并且总宽度F为约3.5cm,尺寸C为约1.0cm,尺寸D为约1.5cm,尺寸E为约3.0cm,尺寸G为约1.0cm,并且尺寸H为约0.5cm。
本领域技术人员将理解,可将装置100切割或修剪至用于上述范围内的伤口的大小。在实施过程中,希望伤口闭合条带110从伤口或切口部位的纵向端部延伸大约至少0.3cm,优选1cm。
设想了本发明的另选实施方案,其中装置包括伤口闭合装置,该伤口闭合装置是多分段的,并且包括若干个单独的伤口闭合装置,如图12至图24中所示。在图25至图30中示出使用此类装置的方法。
参照图12,装置100包括伤口闭合条带110和剥离衬垫组件140,该剥离衬垫组件140具有由切割部5分离的第一区段120和第二区段130。装置100还包括若干个单独的伤口闭合装置的穿孔片段100a、100b、100c、100d和100e。该实施方案展示了本发明在能够提供可更适用于闭合较小切口(诸如切口在0.5-1.5cm范围内的腹腔镜手术中产生的那些切口)的装置阵列方面的多功能性。此外,在该实施方案中,伤口闭合条带110与剥离衬垫组件140共延。下面描述其中伤口闭合条带110不与剥离衬垫组件140共延的另选实施方案。
图13描绘图12的伤口闭合装置100(在从多分段阵列分离、移除剥离衬垫和施用到伤口之前)的底视图,该伤口闭合装置100具有总分段长度A'和宽度B,并且包括非对称的两部分剥离衬垫。更具体地,分段装置110a、100b、100c、100d和100e分别由穿孔pa、pb、pc和pd分离。进一步参考分段装置100a,具有长度A和宽度B的该装置包括顶侧边缘1、底侧边缘2、左边缘3和右边缘4。
图14描绘图12的伤口闭合装置100的顶视图,该伤口闭合装置100包括非对称的两部分剥离衬垫组件140,该剥离衬垫组件140包括由切割部5分离的具有宽度E的第一区段120和具有宽度D的第二区段130。
图15、图16、图17和图18分别描绘装置100的上边缘视图、下边缘视图、左侧边缘视图和右侧边缘视图。
图13和图14的伤口闭合装置100a的典型和优选尺寸为:
一般来讲,特别是参考图13的装置100a,装置100a可具有允许用户有效地施用以闭合伤口或切口的任何长度A和宽度B。尺寸A'(多分段装置100的总长度)将随长度A变化而变化。例如,对于包括5个单独的伤口闭合装置片段(即,100a、100b、100c、100d和100e)的装置100,长度A'将是长度A的五倍。对于许多应用,长度A通常将在约1cm至约8cm、优选约1.5cm至约5cm的范围内,并且最优选为约3cm。宽度B通常将在约1.0cm至约12cm、优选约1.5cm至约7cm的范围内,并且最优选为约3.0cm。
另外,伤口闭合条带110a可具有允许用户有效地施用以闭合伤口或切口的任何长度A。对于许多应用,长度A通常将在约1cm至约8cm、优选约1.5cm至约5cm的范围内,并且最优选为约3cm。
尺寸C是伤口闭合装置100a的中线与第一区段120和第二区段130之间的剥离衬垫切割部5之间的距离。尺寸C使得剥离组件成为非对称的两部分组件。如果尺寸C等于0cm,则剥离组件将不再是非对称的,因为那时剥离组件切割部5将在中线处,并且因此第一剥离区段120和第二剥离区段130将具有相等的宽度。因此,尺寸C应大于0,并且优选在0.1cm至约2cm的范围内,并且最优选为约1.0cm。
尺寸D在0.5cm至约4cm、优选约0.5cm至约3cm的范围内,并且最优选为约1.5cm。在上述范围内,通过伤口闭合条带110和第二区段130的充分重叠来便利地操控装置100a,以充分地实现伤口的分离的局部组织表面的接近。
尺寸E是第一区段120的宽度,并且与伤口闭合条带110a的宽度的相关,伤口闭合条带110a的该宽度适于用户定位和/或重新定位伤口闭合条带110a,用于伤口的分离的局部组织表面的初始接近。尺寸E在0.5cm至约6cm、优选约1.0cm至约5cm的范围内,并且最优选为约1.5cm。在上述范围内,伤口闭合条带110a充分地使大小在0.25cm至约7cm的范围内的伤口接近并覆盖该伤口。
关于以上指出的各种尺寸,本领域技术人员将认识到,本发明的伤口闭合装置的其它尺寸是可能的,这取决于本领域技术人员可选择并调适以处理各种大小和形状的伤口或切口的具体尺寸。另外,例如参照图13,设想伤口闭合条带110(100a)周边不需要与装置100(100a)周边的部分共延,并且可部分地共延或完全不共延,这取决于伤口闭合条带110和剥离衬垫组件140之间的边沿是否为期望的。
对于处理约2cm的手术伤口切口,装置100a的优选实施方案的总长度A为约4cm并且总宽度B为约4.5cm,伤口闭合条带110a的总长度A为约4cm并且总宽度F为约3.5cm,尺寸C为约1.0cm,尺寸D为约1.5cm,尺寸E为约3.0cm,尺寸G为约1.0cm,并且尺寸H为约0.5cm。
本领域技术人员将理解,可将装置100a切割或修剪至用于上述范围内的伤口的大小,或可甚至将装置100a叠覆上述范围内的伤口。在实施过程中,希望伤口闭合条带110a从伤口或切口部位的纵向端部延伸大约至少0.3cm,优选1cm。此外,作为叠覆的示例,设想使用3个长度为3cm的伤口闭合条带100a来闭合长度为7cm的伤口。叠覆多个伤口闭合条带110a提供闭合可具有曲线形状的伤口的优点。
图19以具有总长度A'和宽度的伤口闭合装置100(在从多分段阵列分离、移除剥离衬垫和施用到伤口之前)的底视图描绘了本发明的另选实施方案,该伤口闭合装置100包括非对称的两部分剥离衬垫。更具体地,分段装置110a、100b、100c、100d和100e分别由穿孔pa、pb、pc和pd分离。进一步参考分段装置100a,具有长度A和宽度B的该装置包括顶侧边缘1、底侧边缘2、左边缘3和右边缘4。该实施方案是伤口闭合条带110周边不与装置100的周边共延的情况的示例。
图20描绘图19的伤口闭合装置100的顶视图,该伤口闭合装置100包括非对称的两部分剥离衬垫。
图21、图22、图23和图24分别描绘如图19和图20描绘的装置100的上边缘视图、下边缘视图、左侧边缘视图和右侧边缘视图。
图19和图20的伤口闭合装置100a的典型和优选尺寸为:
关于以上指出的各种尺寸,本领域技术人员将认识到,本发明的伤口闭合装置的其它尺寸是可能的,这取决于本领域技术人员可选择并调适以处理各种大小和形状的伤口或切口的具体尺寸。
一般来讲,装置100a可具有允许用户有效地施用以闭合伤口或切口的任何长度A和宽度B。尺寸A'(多分段装置100的总长度)将随长度A变化而变化。例如,对于包括5个单独的伤口闭合装置片段(即,100a、100b、100c、100d和100e)的装置100,长度A'将是长度A的五倍。对于许多应用,长度A通常将在约1cm至约8cm、优选约1.5cm至约5cm的范围内,并且最优选为约3cm。宽度B通常将在约1.0cm至约12cm、优选约1.5cm至约7cm的范围内,并且最优选为约5cm。
另外,伤口闭合条带110a可具有允许用户有效地施用以闭合伤口或切口的任何长度A和宽度F。对于许多应用,长度A通常将在约1cm至约8cm、优选约1.5cm至约5cm的范围内,并且最优选为约3cm。宽度F通常将在约1.0cm至约8cm、优选约2cm至约6cm的范围内,并且最优选为约3.5cm。
尺寸C是伤口闭合装置100的中线与第一区段120和第二区段130之间的剥离衬垫切割部5之间的距离。尺寸C使得剥离组件成为非对称的两部分组件。如果尺寸C等于0cm,则剥离组件将不再是非对称的,因为那时剥离组件切割部5将在中线处,并且因此第一剥离区段120和第二剥离区段130将具有相等的宽度。因此,尺寸C应大于0,并且在0.1cm至约2cm、优选约0.5cm至约1.5cm的范围内,并且最优选为约1.0cm。
尺寸D在0.5cm至约5cm、优选约0.5cm至约4cm的范围内,并且最优选为约2cm。在上述范围内,通过伤口闭合条带110a和第二区段130的充分重叠来便利地操控装置100,以充分地实现伤口的分离的局部组织表面的接近。
尺寸E是第一区段120的宽度,并且与伤口闭合条带110a的宽度的相关,伤口闭合条带110a的该宽度适于用户定位和/或重新定位伤口闭合条带110a,用于伤口的分离的局部组织表面的初始接近。尺寸E在0.5cm至约7cm、优选约1.0cm至约5cm的范围内,并且最优选为约3.0cm。在上述范围内,伤口闭合条带110a充分地使大小在.25cm至约7cm的范围内的伤口接近并覆盖该伤口。
尺寸G在0.25cm至约4cm、优选约0.5cm至约2cm的范围内,并且最优选为约1.0cm。在上述范围内,便利地操控装置100a,而不破坏伤口闭合条带110a的面向伤口侧面的压敏粘合剂。
尺寸H在0.25cm至约4.0cm、优选约0.5cm至约2.0cm的范围内,并且最优选为约1cm。在上述范围内,通过第二区段130充分粘附到伤口闭合条带110a来便利地操控装置100a,以实现伤口的接近。
对于处理约2cm的手术伤口切口,装置100a的优选实施方案的总长度A为约4cm并且总宽度B为约4.5cm,伤口闭合条带110a的总长度A为约4cm并且总宽度F为约3.5cm,尺寸C为约1.0cm,尺寸D为约1.5cm,尺寸E为约3.0cm,尺寸G为约1.0cm,并且尺寸H为约0.5cm。
本领域技术人员将理解,可将装置100a切割或修剪至用于上述范围内的伤口的大小,或可甚至将装置100a叠覆上述范围内的伤口。在实施过程中,希望伤口闭合条带110a从伤口或切口部位的纵向端部延伸大约至少0.3cm,优选1cm。此外,作为叠覆的示例,设想使用3个长度为3cm的伤口闭合条带100a来闭合长度为7cm的伤口。叠覆多个伤口闭合条带110a提供闭合可具有曲线形状的伤口的优点。
适用于本发明的伤口闭合条带包括任何适于闭合伤口的合适条带。优选地,伤口闭合条带是多孔的并且将允许可流动的可聚合粘合剂渗透条带且允许将条带充分粘合到被粘合的组织表面。
伤口闭合条带包括面向伤口的侧面和顶侧面。面向伤口的侧面还包括在面向伤口的侧面的至少一部分上施用的粘合剂,诸如压敏粘合剂(PSA)。粘合剂可设置在伤口闭合条带的整个面向伤口侧面上。PSA可用于使伤口初始接近。伤口闭合条带优选是多孔的。本文中所谓“多孔的”是指伤口闭合条带的主体有孔,使得随后施用的可聚合粘合剂组合物浸透主体材料或被其吸收,或者是指伤口闭合条带的主体有孔隙(类似网或筛),使得随后施用的可聚合粘合剂组合物直接穿过主体材料,而不论是否浸透主体材料或被其吸收。例如,对于纺织材料来说,“多孔的”通常用来表示所施用的粘合剂组合物渗透并穿过纤维之间的空隙,但不一定进入和穿过纤维本身。优选地,伤口闭合条带为网片。
此类多孔性(或诸如疏水性或亲水性之类的其它性质)还将允许在使用前将聚合引发剂或调速剂装载到伤口闭合条带中或上,以激发随后施用的可聚合粘合剂组合物。此类多孔性还将优选允许空气和流体通过孔本身或者通过主体材料中的孔隙穿过伤口闭合条带。根据孔隙度和/或开口的尺寸,可以调整网片的此类多孔性或空气和流体渗透穿过网片的能力,以便在形成最终组合物之后得以保持,或者让这种多孔性消失。伤口闭合条带还优选为无毒的,因为其旨在用于覆盖伤口,诸如生物组织上的伤口。因此,伤口闭合条带应与所需基底(诸如组织、皮肤、器官等)具有生物相容性,并且优选为政府批准使用或通常认为对于期望用途安全的材料。例如,合适的伤口闭合条带为网片材料并且在美国专利申请2006/0009099和2005/0182443中有所公开,所述专利的全文以引用方式并入本文中。
合适的伤口闭合条带材料可由合成或天然材料形成。此类材料可由织造或非织造织物或材料形成。伤口闭合条带可为例如任何合适的聚合物膜、塑性泡沫(包括开孔泡沫)、织造物、针织织物、非织造织物、它们的混合物等。
具体地,合适的伤口闭合条带因此可由例如下列材料制成:尼龙、聚烯烃膜(诸如聚乙烯、聚丙烯、乙烯丙烯共聚物和乙烯丁烯共聚物)、聚氨酯、聚氨酯泡沫、聚苯乙烯、增塑聚氯乙烯、聚酯、聚酰胺、聚乳酸、聚乙醇酸、聚己内酯、上述材料的共聚物混合物以及棉。合适的具体示例包括例如尼龙、聚乙烯、聚丙烯、乙烯丙烯共聚物、乙烯丁烯共聚物、聚氨酯、聚苯乙烯、增塑聚氯乙烯、聚酯、聚酰胺、棉、聚四氟乙烯(PTFE)、生物血管材料、胶原、等。
伤口闭合条带可由合成、半合成或天然有机材料形成。因此,例如伤口闭合条带可由合成或天然聚合物材料形成,但不由诸如金属(诸如银、钢等)或玻璃或陶瓷的材料形成。伤口闭合条带可为可生物降解的或不可生物降解的。伤口闭合条带优选抗撕扯。
伤口闭合条带的厚度可为约0.05mm至约10mm。在另一个实施方案中,伤口闭合条带的厚度为约0.1mm至约7mm、优选为约0.3mm至约5mm、并且最优选为约0.3mm至约3mm。
伤口闭合条带可被选择为具有弹性或具有一些记忆效应。在此类实施方案中,网片的弹性性能可以在施用位置有利地提供一定程度的压力或应力,以便例如保持创口边缘的对合。同样,在此类附加程度的压力或应力在施用位置处不可取的实施方案中,可以选择弹性较小或没有弹性的网片。
伤口闭合条带可为可生物降解的或不可生物降解的。所谓“可生物降解的”是指网片在体内会随时间而生物降解,使得在一定时间后不需要物理移除网片。因此,例如,可生物降解的网片是指在体内环境中经过从约一周至约五年的时间内会生物降解的网片。不可生物降解的材料是指在体内环境中经过约五年的时间不会生物降解的材料。此类不可生物降解的材料因此将需要在所需时间以物理方式移除伤口闭合条带,而不是随时间推移慢慢消耗或可从组织自然地脱落。
伤口闭合条带优选包括位于其中或其上的一种或多种化学材料。例如,可在伤口闭合条带内或伤口闭合条带上分散一种或多种化学物质,诸如通过化学粘合、物理粘合、吸收或吸附到伤口闭合条带。因此,例如,伤口闭合条带优选包括至少一种聚合引发剂或调速剂,并且可任选地包括一种或多种生物活性材料。根据需要,可将一种或多种化学物质固定到伤口闭合条带中或伤口闭合条带上,例如使得其具有期望的效应,但在使用过程中又不会脱离伤口闭合条带。
例如,可将聚合引发剂或调速剂装载到伤口闭合条带内或伤口闭合条带上,使得引发剂或调速剂为后续施用的可聚合粘合剂组合物提供期望的引发或调速效应。聚合引发剂或调速剂可固定到伤口闭合条带中或伤口闭合条带上,使得引发剂或调速剂不会脱离伤口闭合条带,并且将其残余物分散到所得的聚合材料中。作为另外一种选择,例如,聚合引发剂或调速剂可初始连接到伤口闭合条带,不过只是以特定的方式连接,使得其被后续施用的可聚合粘合剂组合物带动或溶解并且分散到所得的聚合材料中。
如果需要,一组化学物质还可设置在伤口闭合条带中或伤口闭合条带上,以提供多种效应。例如,如上所述,可将第一化学物质(诸如聚合引发剂或调速剂)固定到伤口闭合条带中或伤口闭合条带上,同时将不同的第二化学物质(诸如生物活性材料)可脱离地连接到伤口闭合条带。可以设想多种化学物质的其它组合和所得效应。
可将化学物质以均匀方式涂敷到伤口闭合条带上,使得整个伤口闭合条带上的化学物质的浓度基本上均匀。作为另外一种选择,化学物质可被涂敷成使得在伤口闭合条带的横向或纵向上存在浓度梯度。例如,在伤口闭合条带中央或边缘处可存在浓度较大或较小的化学物质,或者可在伤口闭合条带的一侧面上施用与相对侧面相比浓度较大或较小的化学物质。此外,可以均匀的方式将化学物质施用到伤口闭合条带,或者可以无规或图案化(诸如线、点、同心圆等)的不均匀方式进行施用。化学物质也可位于施用于伤口闭合条带的粘合剂层上、下方或其内。
当存在于伤口闭合条带内或伤口闭合条带上时,化学物质(即聚合引发剂、调速剂和/或生物活性材料或其它添加剂)可通过任何合适的方式结合在伤口闭合条带内或伤口闭合条带上。例如,可通过用含有化学物质的溶液、混合物等接触伤口闭合条带将化学物质添加到伤口闭合条带。可通过例如浸渍、喷涂、辊涂、凹版涂布、刷涂、气相沉积等将化学物质添加到伤口闭合条带。作为另外一种选择,可在制造伤口闭合条带的过程中,诸如在对伤口闭合条带进行模制、针织/纺织、擦洗、帐篷状覆盖、编织或其它加工过程中,将化学物质结合在伤口闭合条带内或伤口闭合条带上。
可存在于伤口闭合条带内或伤口闭合条带上的其它化学物质包括但不限于增强复合结构性能的任何合适的并且优选相容的添加剂。此类附加的化学物质可以为生物活性的或无生物活性的。因此,合适的其它化学物质包括但不限于着色剂(诸如油墨、染料和颜料)、香料、不化学脱离的保护涂层、热敏剂、药剂、伤口愈合剂、抗菌剂等。
装载到伤口闭合条带内或伤口闭合条带上的聚合引发剂或调速剂可提供许多优点,例如调节所施用的可聚合粘合剂组合物的定形时间或聚合时间。例如,可选择施用到伤口闭合条带的引发剂的类型和/或浓度,以加快或减慢聚合时间。聚合引发剂或调速剂的浓度可增大,从而得到更快的聚合时间;或者可减小,从而得到减慢的聚合时间。
由于聚合引发剂或调速剂直接装载在伤口闭合条带内或伤口闭合条带上,因此施用前没必要混合可聚合粘合剂组合物和聚合引发剂或调速剂。这样可以延长作用时间,从而可以在更长的时间内上更精确而小心地涂敷可聚合单体组合物。
此类合适的引发剂是本领域所已知的,并且在例如均以引用的方式全文并入本文的美国专利第5,928,611号和第6,620,846号以及也以引用方式全文并入本文中的美国专利申请第2002/0037310号中描述。可用作聚合反应引发剂的氯化季铵盐和溴化季铵盐尤其合适。例如,可以使用诸如杜灭芬、氯化丁酰胆碱、溴苄烷铵、氯化乙酰胆碱等季铵盐。
可以使用苯扎烷铵或苄基三烷基铵的卤化物,如苄基三烷基氯化铵。使用过程中,苯扎烷铵卤化物可以为不纯净状态的苯扎烷铵卤化物,其包含不同链长的化合物的混合物,或者也可以为包含链长从约12至约18个碳原子的化合物的混合物的任何合适纯净化合物,包括,但不限于,C12、C13、C14、C15、C16、C17和C18化合物。例如,引发剂可以为诸如苄基三烷基氯化铵(BTAC)的氯化季铵盐。
在无不当实验的情况下,本领域的普通技术人员也可以选择其它引发剂或加速剂。此类合适的引发剂或加速剂可以包括(但不限于)洗涤剂组合物;表面活性剂:例如,非离子表面活性剂,诸如聚山梨醇酯20(例如ICI Americas的吐温20TM)、聚山梨醇酯80(例如ICI Americas的吐温80TM)和泊洛沙姆;阳离子表面活性剂,诸如四丁基溴化铵;阴离子表面活性剂,诸如十四烷硫酸钠;以及两性或两性离子表面活性剂,诸如十二烷基二甲基(3-磺丙基)氢氧化铵、内盐;胺、亚胺和酰胺,比如咪唑、精氨酸和聚维酮;膦、亚磷酸盐和鏻鎓盐,诸如三苯基膦和亚磷酸三乙酯;醇,诸如乙二醇、没食子酸甲酯;单宁;无机碱和盐,比如亚硫酸氢钠、硫酸钙和硅酸钠;硫化合物,诸如硫脲和多硫化物;聚合环醚,比如莫能菌素、无活菌素、冠醚、杯芳烃和聚合环氧衍生物;环状和无环碳酸酯,诸如碳酸二乙酯;相转移催化剂,诸如季铵氯化物336;金属有机化合物,诸如环烷酸钴和乙酰丙酮锰;以及自由基引发剂或促进剂,比如二叔丁基过氧化物和偶氮二异丁腈。
可使用两种或更多种诸如三种、四种或更多种引发剂或加速剂的混合物。多种引发剂或加速剂的组合可能有益于例如定制可聚合单体种类的引发剂。例如,当使用单体的共混物时,引发剂的共混物可以为单种引发剂提供优良的结果。例如,引发剂的共混物可以提供优先引发一种单体的一种引发剂,以及优先引发另一种单体的第二引发剂,或者可以提供初始速率,以帮助确保两种单体种类以相同或所需的不相同速率引发。这样,引发剂的共混物可有助于最小化所需引发剂的数量。此外,引发剂的共混物可以增强聚合反应动力学作用。可以使用本领域已知的浸渍法将聚合反应引发剂、加速剂、调速剂和/或交联剂掺入网片内。
两部分剥离衬垫组件是包括可单独剥落的区段的背衬膜。第一区段120与伤口闭合条带110的至少一部分共延,并且与第二区段130相比具有更大的宽度。第二区段130包括与伤口闭合条带110不共延的至少一部分。区段130的该非共延部分允许操纵和放置伤口闭合条带110,而不扰动或破坏伤口闭合条带110的面向伤口侧面上包含的压敏粘合剂。在一些情况下,可以设想的是,第二区段130可比第一区段120宽,以在使分离的局部组织表面接近时帮助操纵和夹持伤口闭合装置。
本发明的剥离衬垫组件的材料可为任何合适的背衬或剥离材料,所述背衬或剥离材料用于覆盖施用到伤口闭合条带的面向伤口的侧面的粘合剂物质。此类背衬材料是本领域中熟知的用于覆盖粘合剂的材料,并且可包括例如纸、塑料等。例如,剥离衬垫组件可为经硅树脂处理的材料。优选地,剥离衬垫组件为防止或消除伤口闭合条带粘附到自身的材料。
本文所公开的伤口闭合或组织粘合方法包括在将伤口闭合条带施加到组织或伤口部位之后将可聚合粘合剂组合物施用到伤口闭合条带上。可聚合粘合剂组合物可包括可聚合单体粘合剂。在实施方案中,可聚合粘合剂组合物包括可聚合1,1-二取代乙烯单体制剂。在实施方案中,可聚合粘合剂组合物包括氰基丙烯酸酯制剂。在实施方案中,可以使用合成的可聚合粘合剂材料,诸如聚氨酯、聚乙二醇、丙烯酸酯、戊二醛和生物基粘合剂。
可单独或结合使用的合适a-氰基丙烯酸酯单体包括a-氰基丙烯酸烷基酯,诸如2-辛基氰基丙烯酸酯;十二烷基氰基丙烯酸酯;2-乙基己基氰基丙烯酸酯;氰基丙烯酸丁基酯,例如n-氰基丙烯酸丁基酯;氰基丙烯酸乙基酯;甲基氰基丙烯酸酯或其它α-氰基丙烯酸酯单体,诸如甲氧基乙基氰基丙烯酸酯;2-乙氧基乙基氰基丙烯酸酯;3-甲氧基丁基氰基丙烯酸酯;2-丁氧基乙基氰基丙烯酸酯;2-异丙氧基乙基氰基丙烯酸酯;以及1-甲氧基-2-丙基氰基丙烯酸酯。在实施方案中,单体为乙基、n-丁基或2-辛基α-氰基丙烯酸酯。可用的其它氰基丙烯酸酯单体包括烷基氰基丙烯酸酯,诸如通过用氰基乙酸烷基酯或烷基氰基乙酸酯与多聚甲醛进行Knoevenagel反应,接着将所得低聚物进行热裂化和蒸馏来制备的那些。
本文所公开的伤口闭合装置可以包括附加部件的套件形式提供。套件可包括如本文所述的至少一个伤口闭合条带,以及可聚合粘合剂组合物的一个或多个容器。在将部件或部件组包装到套件内之前,可在单独的容器内将不同的部件或部件组进行灭菌,并且之后按照共同转让的授权前美国专利公布第2004/0120849号中所公开的那样对套件进行灭菌,该专利公布全文以引用方式并入本文。
在伤口闭合条带上使用的粘合剂物质可以是例如任何合适的粘合剂物质。优选地,该粘合剂为医用等级的粘合剂,诸如丙烯酸基压敏粘合剂(PSA)、橡胶基压敏粘合剂、有机硅压敏粘合剂以及它们的混合物等。优选的是,粘合剂与可聚合粘合剂组合物不同。因此,例如,优选的是,当可聚合粘合剂组合物可以是例如可聚合单体粘合剂组合物时,所述粘合剂为可聚合粘合剂组合物以外的材料,诸如压敏粘合剂。
合适的橡胶基PSA包括,但不限于,美国专利第5,705,551号和美国专利第4,080,348号中教导的橡胶基PSA,所述专利的公开内容以引用方式并入本文。橡胶基聚合物的示例包括下列物质中的一种或多种:苯乙烯-异戊二烯-苯乙烯聚合物、包括苯乙烯-乙烯/丙烯-苯乙烯聚合物在内的苯乙烯-烯烃-苯乙烯聚合物、聚异丁烯、苯乙烯-丁二烯-苯乙烯聚合物、聚异戊二烯、聚丁二烯、天然橡胶、有机硅橡胶、丙烯腈橡胶、腈橡胶、聚氨酯橡胶、聚异丁烯橡胶、丁基橡胶、包括溴化丁基橡胶在内的卤化丁基橡胶、丁二烯-丙烯腈橡胶、聚氯丁二烯以及苯乙烯一丁二烯橡胶。
尤其可用的橡胶基粘合剂为具有热塑性弹性体组分和树脂组分的橡胶基粘合剂。热塑性弹性体组分包含约55-85份简单的A-B嵌段共聚物,其中A嵌段衍生自苯乙烯同源物,B嵌段衍生自异戊二烯,和约15-45份线性或自由基A-B-A嵌段共聚物,其中A嵌段衍生自苯乙烯或苯乙烯同源物,B嵌段衍生自共轭二烯或低碳烷烃,A-B嵌段共聚物中的A嵌段包含约10-18重量%的A-B共聚物,A-B和A-B-A共聚物总共含有约20%或更少的苯乙烯。树脂组分基本上由弹性体组分的增粘剂树脂组成。一般来讲,可使用任何相容的常规增粘剂树脂或此类树脂的混合物。其中包括烃基树脂、松香和松香衍生物、聚萜烯以及其它增粘剂。粘合剂中每一百重量份热塑性弹性体组分可包含约20-300份树脂组分。一种此类橡胶基粘合剂可以商品名HM3210从Ato Findley商购获得。
可用的丙烯酸基PSA包括但不限于下列专利中教导的那些:美国专利第5,947,917号和美国专利第5,164,444号(丙烯酸乳状液)及美国专利第5,623,011号(增粘丙烯酸乳状液)。也可以是具有引发剂的单体和其它成分的辐射固化性混合物,诸如美国专利第5,232,958号(UV固化丙烯酸类)和美国专利第5,232,958号(EB固化)中教导的那些。这些专利的公开内容以引用方式并入本文。
可以设想的是,可使用能够形成粘合剂层的任何丙烯酸基聚合物,其粘合剂层具有足够的粘性,以将其粘合到伤口闭合条带、背衬膜或基底,并且与皮肤有可接受的粘合力。在某些实施方案中,用于压敏粘合剂层的丙烯酸聚合物包括通过下列物质的至少一种的聚合反应形成的那些:酸烷基酯单体或甲基丙烯酸酯、不饱和羧酸和任选地乙烯基内酰胺。合适的丙烯酸烷基酯或甲基丙烯酸酯的示例包括但不限于,丁基丙烯酸酯、丙烯酸乙酯、2-丙烯酸乙基己酯、丙烯酸异辛酯、异壬基丙烯酸酯、异癸基丙烯酸酯、甲基丙烯酸酯、甲基丙烯酸丁酯、4-甲基-2-丙烯酸戊酯、丙烯酸仲丁酯、乙基甲基丙烯酸酯、异癸基甲基丙烯酸酯、甲基丙烯酸甲酯等,以及它们的混合物。合适的烯键式不饱和羧酸的示例包括但不限于,丙烯酸、甲基丙烯酸、富马酸、衣康酸等,以及它们的混合物。优选的烯键式不饱和羧酸单体为丙烯酸。合适的乙烯基内酰胺的示例包括但不限于,N-乙烯基己内酰胺、1-乙烯基-2-哌啶酮、1-乙烯基-5-甲基-2-吡咯烷酮、乙烯基吡咯烷酮等、以及它们的混合物。
可用的有机硅压敏粘合剂包括可从Dow Corning Corp.、Medical Products商购获得的产品和从General Electric获得的产品。可得自Dow Corning的硅树脂粘合剂的示例包括以商品名BIO-PSA X7-3027、BIO-PSA X7-4919、BIO-PSA X7-2685、BIO-PSA X7-3122和BIO-PSA X7-4502销售的产品。有机硅压敏粘合剂的附加示例描述于美国专利第4,591,622号、第4,584,355号、第4,585,836号和第4,655,767号中,这些专利的全部公开内容以引用方式并入本文。
粘合剂也可以包括一种或多种增粘剂、增塑剂、抗氧化剂、诸如蜡的切削剂、和表面活性剂。可以少量(通常少于约25重量%的弹性体相)加入粘合剂层中的其它任选材料包括pH控制剂、药剂、杀菌剂、生长因子、诸如胶原的伤口愈合组分、抗氧化剂、除臭剂、香料、抗菌剂和杀真菌剂。
图7至图11描绘使用本发明的装置的步骤。
具体地并参照图7,一旦已经识别出合适的伤口W以用于通过将局部组织表面TS1与局部组织表面TS2接合来闭合组织T,则在握住第二区段130(例如用右手RH)的同时,通过抓握和牵拉区段120(例如用左手LH)移除伤口闭合装置100的第一区段120,以将第一区段120与伤口闭合条带110分离。接下来,图8示出装置沿组织T的伤口W的一侧轴向定位并且接触第一分离的局部组织表面TS1。图9描绘在伤口W的一侧的组织表面TS1被牵拉,以通过牵拉第二区段130使伤口W的第二分离的局部组织表面TS2接近伤口W的第一分离的局部组织表面TS1。图10示出第二区段130从伤口闭合条带110移除并且伤口闭合条带110被用户更牢固地固定到局部组织表面TS2。一旦伤口闭合条带110牢固地接触组织T并且使伤口W的TS1接近TS2,图11示出施用从施用装置800施用的合适的可流动的可聚合粘合剂,该粘合剂渗透伤口闭合条带110以形成膜810。
图25至图30描绘通过将局部组织表面TS1与局部组织表面TS2接合而将多分段装置实施方案的片段施用到组织T的伤口W的方法中使用的典型步骤。参照这些图,用户完成了用于闭合伤口的方法,该方法包括以下步骤:
a)抓握多分段装置100;(图25)
b)将片段100a从装置100分离;(图26)
c)从装置100a移除剥离衬垫140的第一区段120,以暴露涂布有压敏粘合剂的伤口闭合条带110a;(图27)
d)将伤口闭合条带110沿着组织T的伤口W的一侧轴向定位并且接触第一分离的局部组织表面TS1,并且跨伤口W牵拉伤口闭合条带110以使局部组织表面TS1与局部组织表面TS2接近并接合;(图28)
e)移除剥离衬垫140的第二区段130;(图29)以及
f)任选地施用来自施用装置800的可聚合液体粘合剂以在伤口闭合条带110上形成膜810。(图30)
本发明的方法、装置和系统的优点包括:通过邻接伤口W的分离的局部组织表面,清楚地看见如何放置伤口闭合条带110以使伤口W接近;在将伤口闭合条带110完全放置在经邻接的局部组织表面上之前,灵活地重新定位伤口闭合条带110并调整对伤口W的接近程度(即,邻接W的分离的局部组织表面);能够在不破坏或最少破坏伤口闭合条带110的粘合剂侧面的情况下操控伤口闭合条带110的放置;由于第二区段130为伤口闭合条带110提供刚性,因此在组织接近期间伤口闭合条带110的操纵更稳定。
应当理解本发明的前述公开内容和描述是例示性的和说明性的,并且可以在不脱离本发明实质的情况下在尺寸、形状和材料以及优选实施方案的具体实施方式方面进行各种更改。
Claims (20)
1.一种伤口闭合装置,所述伤口闭合装置具有长度A、宽度B、上边缘、下边缘、右边缘和左边缘,所述伤口闭合装置包括:
伤口闭合条带,所述伤口闭合条带具有长度A、宽度F、面向伤口侧面、顶侧面、上边缘和下边缘,所述面向伤口侧面包含施用在所述面向伤口侧面的至少一部分上的粘合剂;
剥离衬垫组件,所述剥离衬垫组件通过所述粘合剂可拆离地粘附到所述伤口闭合条带,所述剥离衬垫组件由具有长度A和宽度E的第一区段和具有长度A和宽度D的第二区段组成;
其中所述剥离衬垫组件延伸所述伤口闭合装置的全长度A并且延伸所述伤口闭合装置的全宽度B,使得所述剥离衬垫组件形成无伤口闭合条带的突片,其中所述无伤口闭合条带的突片具有从所述伤口闭合装置的所述下边缘延伸到所述伤口闭合条带的所述下边缘的宽度G;
其中所述伤口闭合条带的所述宽度F比所述第一区段的所述宽度E大宽度H,其中H等于长度D减去长度G;并且
其中所述第一区段和所述第二区段通过衬垫切割部彼此分离。
2.根据权利要求1所述的伤口闭合装置,其中:
所述伤口闭合条带是多孔的;
所述长度A为2cm至20cm,并且所述宽度B为1.7cm至12cm;
所述伤口闭合条带具有从所述伤口闭合装置的所述上边缘延伸的宽度F,并且其中F为1.5cm至8cm;
所述无伤口闭合条带的突片具有0.2cm至4.0cm的宽度G;
所述剥离衬垫组件的所述第一区段具有从所述伤口闭合装置的所述上边缘延伸并且为1.5cm至8.0cm的宽度E,并且所述剥离衬垫组件的所述第二区段具有从所述伤口闭合装置的所述下边缘延伸并且为0.2cm至4cm的宽度D,使得所述第一区段的所述宽度E大于所述第二区段的所述宽度D;并且
所述装置的所述宽度B等于所述第一区段的所述宽度E加上所述第二区段的所述宽度D。
3.根据权利要求1所述的伤口闭合装置,其中所述伤口闭合装置是多分段的,并且每个分段装置具有1cm至8cm的长度。
4.根据权利要求3所述的伤口闭合装置,其中所述无伤口闭合条带的突片具有0cm的宽度G。
5.根据权利要求1至4中任一项所述的伤口闭合装置,其中所述伤口闭合条带为网片。
6.根据权利要求1至4中任一项所述的伤口闭合装置,其中所述粘合剂设置在所述伤口闭合条带的整个面向伤口侧面上。
7.根据权利要求1至4中任一项所述的伤口闭合装置,其中所述粘合剂为医用等级的粘合剂,优选选自丙烯酸基压敏粘合剂(PSA)、橡胶基压敏粘合剂、有机硅压敏粘合剂以及它们的混合物。
8.根据权利要求1至4中任一项所述的伤口闭合装置,其中所述伤口闭合条带至少包含聚合引发剂或调速剂。
9.一种套件,所述套件包括:
(a)根据权利要求1至4中任一项所述的伤口闭合装置;以及
(b)可聚合粘合剂组合物,所述可聚合粘合剂组合物用于在已将所述伤口闭合条带施用到组织或伤口部位之后施用在所述伤口闭合条带上。
10.根据权利要求9所述的套件,其中所述可聚合粘合剂组合物与施用到所述伤口闭合条带的所述面向伤口侧面的所述粘合剂不同。
11.一种闭合伤口的方法,所述伤口具有至少第一分离的局部组织表面和第二分离的局部组织表面,所述方法包括以下步骤:
a)利用根据权利要求1至4中任一项所述的装置,并且在权利要求3的情况下,将所述多分段装置的片段进一步分离;
b)在抓握所述剥离衬垫组件的所述第二区段的所述突片的同时,移除所述剥离衬垫组件的所述第一区段,以暴露所述伤口闭合条带的所述面向伤口侧面的一部分;
c)将所述伤口闭合条带的所述暴露的面向伤口侧面的一部分粘附到所述至少第一分离的局部组织表面,并且朝向所述至少第二分离的局部组织表面牵拉所述剥离衬垫的所述第二区段的所述突片,以形成两个邻接的局部组织表面,并且将所述伤口闭合条带的所述暴露的面向伤口侧面进一步粘附到所述至少第二局部组织表面;以及
d)移除所述剥离衬垫组件的所述第二区段以进一步暴露所述伤口闭合条带的面向伤口侧面,并且将所述进一步暴露的伤口闭合条带粘附到所述第二局部组织表面。
12.根据权利要求11所述的方法,所述方法还包括在所述伤口闭合条带上施用可流动的可聚合粘合剂的步骤。
13.根据权利要求12所述的方法,其中所述伤口闭合条带包括网片。
14.根据权利要求13所述的方法,其中所述网片包括选自由聚酯、聚烯烃和聚酰胺组成的组的材料。
15.根据权利要求14所述的方法,其中所述可流动的可聚合粘合剂包含可聚合1,1-二取代乙烯单体。
16.根据权利要求15所述的方法,其中所述可流动的可聚合粘合剂包含α-氰基丙烯酸酯单体。
17.根据权利要求16所述的方法,其中所述网片还包含引发剂。
18.根据权利要求17所述的方法,其中所述引发剂选自由苯扎烷铵和苄基三烷基铵的卤化物组成的组。
19.根据权利要求18所述的方法,其中所述引发剂为苯扎氯铵。
20.根据权利要求19所述的方法,其中所述粘合剂为丙烯酸基压敏粘合剂。
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EP (2) | EP3622925A1 (zh) |
JP (2) | JP2019530507A (zh) |
KR (1) | KR102527447B1 (zh) |
CN (1) | CN109789038B (zh) |
AU (1) | AU2017334567B2 (zh) |
BR (1) | BR112019006007A2 (zh) |
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US20230277386A1 (en) | 2023-09-07 |
KR102527447B1 (ko) | 2023-05-03 |
CN109789038B (zh) | 2021-10-22 |
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US20180085260A1 (en) | 2018-03-29 |
EP3622925A1 (en) | 2020-03-18 |
KR20190062454A (ko) | 2019-06-05 |
AU2017334567A1 (en) | 2019-04-04 |
US20200315858A1 (en) | 2020-10-08 |
WO2018063871A1 (en) | 2018-04-05 |
BR112019006007A2 (pt) | 2019-06-25 |
US11679034B2 (en) | 2023-06-20 |
EP3518848A1 (en) | 2019-08-07 |
MA46332A (fr) | 2019-08-07 |
AU2017334567B2 (en) | 2020-02-20 |
JP2023029559A (ja) | 2023-03-03 |
JP2019530507A (ja) | 2019-10-24 |
US10687986B2 (en) | 2020-06-23 |
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