CN86103931A - 止血胶粘绷带 - Google Patents
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Abstract
本文叙述了一种用于小割伤时能较快止血的止血胶粘绷带,其中在胶粘绷带的多孔塑料膜伤口防粘盖的表面上涂有很薄一层高分子量的聚氧乙烯,涂布的方式适合于通常使用的高速生产技术与设备。
Description
本发明论及胶粘绷带,它由外科胶布衬底及上面的吸收垫组成,吸收垫有一个多孔膜型非粘性的伤口防粘盖。更具体地讲,是关于这样一种胶粘绷带,它的伤口防粘盖涂有一薄层高分子量的聚氧乙烯,以改进此类胶粘绷带敷于小割伤、擦伤及剌伤时的止血功能。
在美国专利3,434,472号(史密斯叔侄有限公司Smith & Nephew Ltd.)中公开了各种在本发明中有用的胶粘绷带,它们都有多孔塑料膜形的伤口防粘盖片,并且是著名的市场上可买到的材料,例如约翰逊与约翰逊公司(Johnson & Johnson)的“救护带”牌(BAND-AID)胶粘绷带(含有非粘性衬垫),有极薄的条、小片、斑点及塑料条等形状;科尔盖特-帕默莱夫(Colgate-Palmolive)公司(肯德尔,Kendall)的“愈伤库拉德”(Curity CURAD)牌“免痛(Ouchless)”胶粘绷带,以及美国白十字药厂的“斯替克-泰特”(STIK-TITE)弹性带。在美国专利3,285,245号(明尼苏达矿业与制造公司)和2,923,298号(肯德尔公司,Kendall Company)中,列有适用于本发明的其它的多孔膜型非粘性伤口防粘盖面。在所有这些胶粘绷带中,伤口防粘盖片都很薄,厚度一般小于10密耳。
已知的这些胶粘绷带,通常是施以轻压敷在小割伤、擦伤和剌伤处,以帮助止血,并防止伤口感染。虽然这些胶粘绷带的效能相当不错,但是若能方便而便宜地提高它们的止血效能,而且仍然利用适合于在商业规模上制造此类胶粘绷带通常所用的各种高速生产技术与设备,则必定更为理想。
多年来一直在寻求改进的止血胶粘绷带。我们曾意外地发现,若在伤口防粘盖片的表面上涂上很薄一层分子量大于约60万道尔顿的聚氧乙烯,则在小的割、擦与剌伤处敷用胶粘绷带以快速止血时,可以大大提高止血效能,同时并不影响不粘伤口的特点。将市场上买到的带有非编织网状聚乙烯伤口防粘盖面的胶粘绷带,与本发明的胶粘绷带相比,后者仅加有约为非编织网重量5%的分子量约400万的聚氧乙烯,但本发明的止血胶粘绷带止住小割伤的出血要快约三分之一。若所用的聚氧乙烯的分子量更高,则达到同样止血效果的需用量还要少。
本发明中使用的“聚氧乙烯”也称作聚环氧乙烷,或称作聚氧乙烯聚合物或树脂,或1,2环氧聚合物,或polyox,或各种其它同义词。它在化学文摘服务处的登录号为25322-68-3。在这里具体用到的聚氧乙烯是平均分子量为60万或更高的高分子量聚合物。
安德逊(Anderson)的标题为“含有止血剂的伤用敷料”的美国专利3,328,259号(转让给帕拉化学公司,Parachem Corporation)描述了一种含有止血剂的伤用敷料的制造工艺,止血剂用的是纤维素衍生物,特别是羧甲基纤维素钠盐。该专利提到聚氧乙烯与具体描述的纤维素衍生物有同样的效能,但未述及如何使用聚氧乙烯的细节。如果用聚氧乙烯替代在所述的现有技术专利所描述的纤维素衍生物,所得的敷料与本发明的止血敷料之间在很多方面很不相同。例如,上述现有技术专利要用“膜式绷带”,此膜相当厚,在1至6密耳量级,而本发明中聚氧乙烯不是以膜的形式,而是以很薄涂层(通常厚度小于0.1密耳)的形式使用,并且此涂层甚至可能不是固体涂层,而是多孔涂层,因为它所涂敷的多孔膜伤口防粘盖片载体含有许多通道,这些通道在涂上聚氧乙烯之后可能没有全部填平。现有技术的膜在敷于伤口时保持膜的状态;而本发明的很薄的聚氧乙烯涂层一用于湿的伤口就立即溶解,不再以膜的形式存在,而是成为粘性溶液。现有技术的膜比可能使用的任何增强衬底都要厚得多,但本发明中的聚氧乙烯涂层比它所涂敷的伤口防粘盖面要薄得多。现有技术的度膜总是含有塑化剂,而对本发明来说则不需要(但可以用)。现有技术的专利既不涉及胶粘绷带,也不涉及专为本发明的胶粘绷带将用于的那类伤口所设计的绷带,它所提到的是使用方法与目的都不同的一类绷带。为了不扰动伤口,在从伤口处取下膜时要用水处理;而本发明的止血绷带,只要以通常的方式扯下就行,它完全不粘伤口。
金(King)的美国专利3,419,006号描述了一种敷料,它使用一层由交联的聚氧乙烯组成的亲水聚合物凝胶。这样一种敷料在结构、大小和操作上与本发明的胶粘绷带完全不同,本发明的胶粘绷带不使用交联形式的聚氧乙烯,而且不使用任何亲水聚合物凝胶。事实上,金(King)的专利的敷料商品在市场上以SPENCO第二皮肤敷料出售(斯宾科(Spenco)医药公司)〔也以C.R.巴德公司的费吉龙(VIGILON)牌基本创伤敷料的形式出售〕,但它的止血效能在试验时还没有现有的普通胶粘绷带对照样那么好。这些敷料有40密耳厚,它们是在聚乙烯网状载体上的一种胶体悬浮液的凝胶,此悬浮液由辐射交联的聚氧乙烯(4%)和水(96%)组成,它们不能作为或者代替本发明的止血胶粘绷带使用。
图1为说明本发明的止血胶粘绷带的平面图,某些部分以剖面方式表示。
图2为沿图1的2-2线所作的横截面图。
图3为图1中胶粘绷带的部件分解透视图。
本发明的止血胶粘绷带由一个内科或外科胶粘绷带组成,包括一个胶带、其上贴着一个吸收垫,垫上盖着一个多孔的塑料膜型非粘性伤口防粘盖片,此盖片上涂有很薄一层由高分子量聚氧乙烯构成的止血剂。
附图说明的全是止血胶粘绷带10的同一典型实例,其中涂胶衬底12上贴着一个吸收垫结构20,它包括吸收垫22,其上覆盖着多孔膜非粘性伤口防粘盖片24,在盖片上涂有很薄一层高分子量聚氧乙烯的涂层26。聚氧乙烯涂层26可以有、也可以没有与防粘盖片24上相对应的孔道。
图上没有画出来,但实际应用时通常使用两条防粘纸(例如硅油涂敷的防粘纸或在使用时容易除去的其它代用材料),目的是用它贴盖住止血胶粘绷带的整个胶面。同样没有画出,但通常要用到的是玻璃纸或类似的隔菌材料作的专用密封包装。每条止血胶粘绷带先放入此封装内,再经受环氧乙烷消毒,以便止血胶粘绷带在使用之前能保持无菌状态。在使用时,先打开封装取出止血胶粘绷带,撕下两条防粘纸,将吸收垫结构20的有聚氧乙烯涂层26的那一面敷在伤口上,然后将涂胶的两端部分粘在皮肤上,使整个结构固定在适当的位置。
本发明的止血胶粘绷带与现有技术的胶粘绷带之间的区别,在于附加的聚氧乙烯涂层26的存在。因此,可用于现有技术的胶粘绷带及其中使用的各种材料和配料的制造方法,也可以用于本发明,但辐射消毒,例如用钴60消毒的方法除外,因为这样作会使聚氧乙烯交联,并使其丧失止血功能。蒸汽消毒法也不能用,但可以采用使用很广的环氧乙烷消毒法。
虽然附图只画了一种形状,但止血胶粘绷带可以采取现有技术的非止血胶粘绷带可能采取的任何形状。
涂胶衬底12可以用任何布料或塑料型纤维,上面涂有压敏型粘结剂,它可以是现有技术非止血胶粘绷带上常用的任何一种。
聚氧乙烯
本发明需要使用聚氧乙烯作为多孔膜伤口防粘盖面的薄涂层来制备止血胶粘绷带。我们曾意外地发现,很少量的聚氧乙烯在减少小伤口出血时间方面很有效,所用的聚氧乙烯在多孔塑料载体、即胶粘绷带防粘垫上成一个很薄的涂层。
对本发明有用的聚氧乙烯树脂,不是象聚氧乙烯被辐照时所发生的那样,交联成凝胶。在描述与申请本专利时,“聚氧乙烯”这个词只是指未经辐照的、未交联的非凝胶形式。
在工业上聚氧乙烯树脂是用环氧乙烷催化聚合而成,有几种不同的金属催化剂,反应时可用其中的任一种。市场上可买到的聚氧乙烯有联合碳化物公司(美国)的“Polyox”,明盛(Meisei)化学公司(日本)的“Alkox”,和清哲(Seitetsu kagaku)化学公司(日本)的“PEO”,其平均分子量由低至200到高达7000000。但是,分子量低于25,000的那些产品是粘性液体或蜡状固体,通常称作聚乙二醇。对本发明有用的聚氧乙烯,其分子量范围由60万至700万,甚至可以更高,倘若以后有产品出售的话。这些聚氧乙烯是干的、不流动的白色粉末,在98℃以下完全溶于水,在某些有机溶剂中也完全溶解。其晶体熔点由63°至67℃。在晶体熔点之上,树脂变成热塑性物质,可以用模塑、挤压或压延成形,随着树脂分子量的增加,其水溶液的假塑性与粘性也增加。
由于这些聚合物中的醚氧电子对对于成氢键有很强的亲合力,聚氧乙烯树脂可与很多种单体的或聚合的有机化合物以及某些无机电解质形成缔合络合物。例如,聚氧乙烯与蛋白质,如明胶、聚脲以及有机化合物,如尿素、硫脲等形成缔合物。
虽然我们不希望把对我们的发明如何起作用的解释局限于任何一种特定的理论,但是可以设想,少量的聚氧乙烯就能使水的粘度增至很高,加上聚氧乙烯又具有与某些蛋白质形成络合物的能力,是这些聚合物具有止血性能的原因。我们推测,当含有少量聚氧乙烯树脂的胶粘绷带敷在出血表面上时,树脂迅速溶解在血液的含水血浆中,从而立即增大了血浆的粘度。与此同时,血液蛋白,例如凝血酶原和纤维蛋白原,开始与聚氧乙烯分子缔合,于是使这些蛋白质的局部浓度增加,与不存在聚氧乙烯时的正常的扩散控制的反应相比。这就使它们之间的相互作用更快。因此,血浆粘度的增加减慢了流血,同时在聚氧乙烯分子表面处基本血液蛋白变浓,这两点设想是聚氧乙烯止血效能的机理。
我们发现,为了使聚氧乙烯分子能快速止血,聚合物必须能迅速溶解在从切口与创伤处流出的血液的血浆中。如果聚氧乙烯是以薄膜形式涂在胶粘绷带的表面上,这一点容易做到。聚氧乙烯的薄涂层可以涂在防粘盖的任何一面,但最好是涂在最靠近伤口的那一面上。
虽然聚氧乙烯是关键的止血材料,但也可以在聚氧乙烯中加入其它水溶性聚合物而不明显减弱聚氧乙烯的止血活性。对于本发明来说,这种混合物被认为是与聚氧乙烯自身完全等效,所加入的其它水溶性聚合物只是一种稀释剂。在任何一种这样的混合物里,主要组分最好是聚氧乙烯,但可以有高至50%重量(相对于包括聚氧乙烯在内的全体聚合物而言)的一种或多种其它的水溶性聚合物。用聚氧乙烯和羧甲基纤维素(50∶50)以及聚氧乙烯与聚乙烯吡咯烷酮(50∶50)的混合物得到了很好的示范结果。用于此用途的有很多种其它的水溶性聚合物,其代表是烷基纤维素、羟烷基纤维素、聚乙烯醇、聚丙烯酰胺和部分水解的聚丙烯酰胺,以及各种天然胶,例如瓜耳胶、藻酸盐、汉生(Xanthan)胶及其它类似物质。
另外,虽然对于本发明来说,在聚氧乙烯中使用塑化剂既非最好、又非必要,但若愿意的话,可以随意加入水溶性塑化剂,例如甘油、聚乙二醇等等。
若是想加入一种或多种水溶性聚合物或水溶性塑化剂时,可以在把聚氧乙烯溶液涂在伤口防粘面上之前加入这些水溶性物质。
我们发现,使用上述水溶性聚合物与水溶性塑化剂作为稀释剂,对于聚氧乙烯的止血活性没有明显的坏作用。防粘盖上的薄涂层的性质与单独使用聚氧乙烯时保持大致相同,并且此材料仍可在高速制造胶粘绷带的设备上顺利加工。
伤口防粘面
很多已知的商品胶粘绷带,在吸收垫的顶上有一个多孔塑料薄膜。塑料膜起伤口防粘盖面的作用,以便当揭开绷带时,不至于撕裂伤疤和重新流血。
这种伤口防粘盖可以由塑料材料制造,其中最常用的有聚乙烯、聚丙烯、聚酯和尼龙。塑料膜为各种形式的多孔形,以便提供小的孔道,使血液流入多孔膜下面的吸收垫。这种塑料防粘盖面也可以是编织的、针织的或非编织结构,只要它具有足以使血流入吸收垫的孔隙。代表性的例子有德尔内特(Delnet)聚乙烯膜和特尔发(Talfa)聚酯膜。
作为各种优良的非粘性伤口防粘盖的例子,有赫尔库勒斯(Hercules)公司作为该公司德尔内特(Delnet)轻质非编织纤维系列之一的商品,它们是由高密度聚乙烯或聚丙烯经过挤压、压纹和定向加工而成。其重量约为每平方码0.36-1.06盎司,厚度约4-10.5密耳,孔道面积占17-46%。我们特别愿意使用德尔内特(Delnet)p-530,它是一种重量为每平方码0.55盎司的高密度聚乙烯,厚度为4.3密耳,孔道面积占34%。在未特地指明使用其它材料的那些例子里,用的都是这种材料。
涂布操作
作为本发明的一部分,我们发现,在伤口防粘盖上涂上一薄层聚氧乙烯(比防粘盖薄得多)是使聚氧乙烯与出血部位接触的很有效的方法。
要在防粘膜上形成聚氧乙烯的薄涂层或膜,既可以先用聚氧乙烯溶液涂在多孔塑料防粘盖上,然后贴在绷带的吸收垫上;也可以先将防粘膜贴在吸收垫上(例如在组合垫的情形),然后用聚氧乙烯涂敷这一整体;二者的效果相同。
在涂布过程中,塑料防粘盖面中的孔道可能有一些甚至全部被聚氧乙烯薄涂层盖住,但是因为涂层或膜很薄(小于0.1密耳),它一遇见血中的血浆就变湿溶解,因此这些孔并没有被这一止血的聚合物涂层或膜堵塞。
为了用聚氧乙烯涂布防粘盖,把在本发明中证明有效的聚氧乙烯(其分子量范围由60万至700万,若有商品,还可更高)溶在各种溶剂或混合溶剂中使之溶液化。
聚合物在溶剂中的浓度可以由低至0.5%到高至6.5%,但是对于分子量400万的聚氧乙烯,最好是2.0-3.0%;对于分子量为700万的聚氧乙烯,最好是1.0-2.0%。可以使用的各种常用溶剂有水、水-甲醇混合物、异丙醇、苯、丙酮和二氯甲烷,但可用的溶剂不限于上述的这些。
另一方面,因为聚氧乙烯是一种低熔点热塑性聚合物,可以将它以熔体形式直接在吸收垫或防粘膜上挤压成薄膜。
我们更愿意采用的方法是将聚氧乙烯用溶剂涂布的方式直接涂在伤口防粘盖上。在组合吸收垫的情形,则直接涂在吸收垫上,因为伤口防粘盖已事先嵌入吸收垫,故它不需要有分离的伤口防粘盖片。
涂布聚氧乙烯的操作最好是用一个逆辊涂胶机进行。涂胶机的型式不属于本发明的范围,因此只是作为已投入使用的一类涂布技术的一个例子来提到。有很多种涂布技术和设备可供制造本发明的止血绷带所用。
涂在胶粘绷带上的高分子量聚氧乙烯的数量,比涂胶机的型式更为重要。我们发现,多孔的高分子伤口防粘盖的重量增加1-10%,即足以产生明显的止血效果。
按照我们的德尔内特(Delnet)伤口防粘盖的原重量计算,对于分子量为400万的聚氧乙烯,最佳涂敷量为3-8%;对于分子量为700万的聚氧乙烯,是2-6%。附加的数量是如此之少,以致用肉眼难以发觉。
制造现有的商品非止血胶粘绷带时用到的高速生产技术和设备,同样可用来制造本发明的止血胶粘绷带。因为本发明的特点是在于伤口防粘盖上的聚氧乙烯涂层,下面的例子将说明发明的这一情况。
例1
在一个大桶里加入29.28千克异丙醇,在快速搅拌下加入0.9千克聚氧乙烯(联合碳化物公司的Polyox树脂WSR-301,分子量400万)。此高分子聚合物分散在醇中,但不溶解。加入5.82千克蒸馏水,慢慢搅动15分钟。当水加入时,聚氧乙烯迅速溶解。这一步骤产生了浓度为2.5%的聚氧乙烯溶液,用布鲁克菲尔德(Brookfield)粘度计一号转子在1转/分下测得粘度为15433厘泊。溶液中异丙醇重量占81.33%,水占16.16%。
将此溶液涂在赫尔库勒斯(Hercules)公司生产的称作德尔内特P-530的网状多孔聚乙烯膜上。聚氧乙烯溶液是用一个逆辊涂胶机涂在德尔内特上,在德尔内特涂上了聚氧乙烯溶液的薄膜之后,使其通过一个温热的炉子将溶剂蒸发掉,在德尔内特上留下了一个很轻的聚氧乙烯膜,然后将德尔内特膜卷起来,其重量增加为8.1%。
将涂布过的德尔内特卷固定在由纸浆作成的吸收垫上,然后切割并贴在涂胶的衬底上,所有这些均由高速机械完成,熟悉胶粘绷带制造技术的人士都了解这些设备。涂布过的德尔内特P-530可以毫无问题地通过这些机械,制得的止血胶粘绷带,在一切方面都与常规的绷带基本上没有区别,只是对割伤测得的出血时间除外。例如,用本例的工艺制得的胶粘绷带对兔耳割伤(人类割伤的模拟)的平均出血时间为49秒,而对照样为83秒(对照样是同样的胶粘绷带,但未涂聚氧乙烯)。
例2
在一个大桶里装入1187.5克甲醇,于快速搅动下加入125克聚氧乙烯(联合碳化物公司的Polyox树脂WSR-205,分子量60万)。聚氧乙烯分散但不溶解。加入1187.5克蒸馏水,当聚合物溶解时减慢搅速,在搅动20分钟后粘度增加。得到在47.5%甲醇、47.5%水中的5%的聚氧乙烯树脂WSR-205的溶液,准备涂布用。此溶液用布鲁克菲尔德(Brookfield)粘度计一号转子在1转/分下测得粘度为5701厘泊。
将此树脂按例1所说的方法涂在德尔内特P-530膜上。用此工艺在多孔的德尔内特聚乙烯膜上铺上了很薄一层聚氧乙烯膜。未涂布的德尔内特P-530膜的重量是每平方码0.450盎司,涂布上的聚氧乙烯重量为每平方码0.027盎司,或原始重量增加6%。
涂布过的德尔内特膜用机械在高速下贴在绷带的吸收垫上,作成胶粘绷带。所用的机械与制造现有技术非止血胶粘绷带中所用的高速工业设备相同。将绷带用环氧乙烷消毒,这不损害止血涂层。将上述绷带在兔耳出血模型上作试验时,止血绷带的平均出血时间为60秒,而未涂敷的对比样为86秒。
例3
本例说明聚氧乙烯树脂用于组合垫。组合垫是将多孔塑料膜或防粘盖面预先固定在吸收垫上,吸收垫的成分为90%聚丙烯与10%的人造纤维。于是,德尔内特P-530膜预先固定在90/10垫上,而后直接在此材料的表面上涂聚氧乙烯。
在58.8%甲醇、39.2%水的混合溶剂中制备2.0%的聚氧乙烯WSR-301溶液(分子量400万)。此溶液用布鲁克菲尔德粘度计1号转子在1转/分下测得粘度为8552厘泊。
将聚氧乙烯溶液(Polyox WSR-301)用逆辊涂胶机涂在组合垫上。在固定于90/10吸收垫上的德尔内特表面上形成了一个聚氧乙烯薄膜。组合垫的重量为每平方码3.145盎司,涂布过的垫重为每平方码3.172盎司,每平方码增重0.027盎司,或者按整个垫计算增重0.85%,若只按德尔内特膜计算,则增重6%。利用在制造非止血胶粘绷带时常用的现有工业设备与技术,将上述材料制成胶粘绷带。在流血兔耳模型试验中,止血绷带的出血时间平均为48秒,而未涂敷的对照样为72秒,标准偏差17秒。
例4
在由58.8%重量的水与39.2%重量的甲醇组成的混合溶剂中,制备2%的Polyox WSRN-60K(分子量200万)溶液。此溶液用布鲁克菲尔德粘度计1号转子在1转/分下测得粘度为4030厘泊。
将此溶液涂在德尔内特多孔聚乙烯膜上,然后通过一个炉子以蒸发掉溶剂。德尔内特膜的增重为8.0%。涂层的厚度小于0.1密耳。涂敷过的德尔内特膜用高速机械固定在吸收垫上,制成胶粘绷带。这些绷带在出血时间试验时,与未涂的对照样相比,出血的时间缩短40%。
例5
本例说明聚氧乙烯对称作特尔法(Telfa)的聚酯多孔膜的影响(此膜用于库尔盖特-帕默莱夫(Colgate-palmolive)公司的称作“愈伤特尔法”(Curity Telfa)胶垫的商品绷带中)。
将含有58.8%甲醇、39.2水和2%重量的Polyox WSR-301溶液,用刮刀涂在称作“特尔法”的多孔聚酯膜上,在聚酯表面上形成0.1密耳厚的、很薄一层聚氧乙烯。将涂布过的特尔法膜放在吸收垫上,对这个临时代用的绷带在流血的兔耳上进行试验。止血绷带的出血时间,比在其它方面都相同但未涂布的对比样要缩短30%。
例6
在一个大桶里加入1773克甲醇,于搅动下加入45克分子量为700万的polyox WSR-303,聚氧乙烯树脂不是溶解而是分散在甲醇中。在搅动下加入1182克水,搅一小时。此步骤产生了在39.4%水、59.1%甲醇中的聚氧乙烯为1.5%的溶液。用布鲁克菲尔德粘度计一号转子在1转/分下测得此溶液的粘度为11100厘泊。
用逆辊涂胶机将此溶液涂在德尔内特P-530上,涂布过的德尔内特膜通过一个温热的炉子蒸发掉溶剂。德尔内特膜的重量增加百分数为3.5%。
涂布过的德尔内特卷固定在纸浆作成的吸收垫上,做成胶粘绷带。这些绷带在进行止血试验时,在兔耳模型上52秒后停止出血,而对照样为85秒。
例7
在一个大桶里加入1746克甲醇和60克polyox WSR-301,在另一个大桶里于1164克水中溶解30克赫尔库勒斯公司的羧甲基纤维素钠(#7H3SCF),搅动溶液两小时,然后将高聚物水溶液加到搅动着的聚氧乙烯甲醇悬浮液中。搅动所得的溶液两小时。此聚合物溶液的布鲁克菲尔德粘度为64,000厘泊;其成分为2.0% polyox WSR-301,1.0%羧甲基纤维素钠盐,38.8%水和58.2%甲醇。
将此溶液涂在德尔内特膜上,于温热的炉中蒸发掉溶剂,增重百分数为7.5%。
用这种涂布过的德尔内特膜做成的胶粘绷带,出血时间为50秒,对照样则为80秒。
例8
在大桶里加入1746克甲醇,于搅动下再加入40克GAF公司的聚乙烯吡咯烷酮K-90。搅动此溶液直到聚乙烯吡咯烷酮溶解,在此溶液中加入40克polyox WSR-301,于搅动下加入1104克水,继续搅一小时,此步骤形成一个聚乙烯吡咯烷酮浓度为1.36%,聚氧乙烯为1.36%,甲醇为59.6%,水为37.7%的聚合物溶液。
用布鲁克菲尔德粘度计一号转子在1转/分的转速下测得溶液的粘度为8800厘泊。
将此溶液涂在德尔内特膜上,于温热的炉中蒸发掉溶剂,德尔内特膜的重量增加为5.0%,涂布过的德尔内特膜象上面说的那样做成胶粘绷带。进行止血试验时,这些绷带在兔耳模型上于58秒内停止出血,而对照样为83秒。
例9
在装有搅拌器的大桶里加入1176克甲醇,于搅动下加入40克分子量为500万的絮凝剂级聚氧乙烯,搅动几分钟,然后加入784克水,搅一小时。此步骤产生一种在58.8%甲醇与39.2%水中的絮凝剂级聚氧乙烯为2.0%的溶液。
用布鲁克菲尔德粘度计一号转子在每分钟一转的转速下,测得此溶液的粘度为7300厘泊。使用逆辊涂胶机将此溶液涂在德尔内特膜上,在温热的炉中蒸发掉溶剂,德尔内特膜的增重为6.0%。由这样涂布的德尔内特膜做成胶粘绷带,在兔耳模型上进行试验时,其出血时间为53秒,而对照样为85秒。
止血试验步骤
本发明的敷料(如前面的例1-5所述)用下述兔耳止血试验来评价,此试验是在实验室中模拟常用到胶粘绷带的那类小割伤。
试验步骤如下:
(1)每只兔子肌肉注射“迷兔”(Rabbit Magic)牌麻醉剂,剂量为每5磅体重1毫升。麻醉剂必须当天新配制:
1毫升 ROMPUN(20毫克/毫升)
2毫升盐酸氯胺酮(100毫克/毫升)
1毫升盐水或水
(2)剃出兔子双耳内侧边缘的静脉,将兔耳置于硬的平面上,用刀片横切开整个静脉,小心不要完全切断。所选择的那段静脉务必彼此一致而且足够粗。
(3)用纱布棉拭擦去切口处的第一滴血,观察伤口应有适度的、但不过多的出血。再次用纱布棉拭擦切口,并立即用一条胶粘绷带样品(透明的或极薄的衬底)垂直于静脉盖住切口,同时启动停表。用姆指轻按在伤口处的样品上5秒钟,以保证样品与切口充分接触。
(4)当看不出再有血流时,以秒为单位记下时间作为止血时间。如果在血止住以前样品就浸透了,则丢掉试样、记录作“浸透”,用新的试样重复步骤2和3。
(5)在同一只耳朵的最初选择的那段静脉上作第二个切口,象上面一样作试验。在每只耳朵上作二至三个切口,以随机方式更迭试样。
采用以上步骤试验了本发明的胶粘绷带,其止血效能(即可见出血停止时的秒数)记录在表1。
为了进行上述的止血试验程序,为须透过作试验的各个胶粘绷带的衬底来观察流血情况,即辨别何时停止出血。因为某些商品胶粘绷带的衬底是不透明的,而且形状与大小各不相同,故对它们作了改造以便于试验。其作法是,使用与商品中所用的同一种带盖的德尔内特吸收垫,但必要时配上一个不同的、虽然仍是商品上使用的涂胶衬底,用通常的高速生产技术和设备,将它们做成一个尺寸为3/4英寸的胶粘绷带,即便这并不是它们的常用尺寸。因此,试验中总是使用“极薄的乙烯基衬底”或“特里科编织物”(Tricot)衬底,这些衬底与三种不同的垫一起使用,即牌号为“救护带(BAND-AID)”的乙烯基胶粘绷带中使用的四重垫(由纸浆和人造纤维制成)(垫A);在“救护带(BAND-AID)”牌乙烯基衬底斑点形小绷带中使用的垫(一种由100%人造纤维制成的组合垫)(垫B);以及在“救护带”牌柔性纤维胶粘绷带特里科(Tricot)网中使用的垫(一种由90%聚丙烯-10%人造纤维制成的组合垫)(垫C)。所有的垫都有一个德尔内特P-530多孔聚乙烯膜伤口防粘盖。
制得了若干批止血胶粘绷带(含有指标为约7%的附加的聚氧乙烯树脂WSR-301涂层),然后以不含聚氧乙烯的同样的胶粘绷带作为对照物进行试验。通常从每批产品中取12个胶粘绷带用于试验。自汇集的数据(对于垫A、B、C的每一种,都取自40至106个试验样品)得到以下结果:
兔耳止血试验
垫的类型 出血时间(秒) 标准偏差(秒)
A-对照样 76.7 18.0
A-加聚氧乙烯 49.5 20.9
B-对照样 67.9 10.7
B-加聚氧乙烯 40.5 20.5
C-对照样 71.8 16.6
C-加聚氧乙烯 48.3 15.6
例6-9的敷料的止血效能用上述的同样的通用程序进行评价。很显然,本发明的止血胶粘绷带具有令人满意的、明显的止血效能。
勘误表
文件名称 页 行 补正前 补正后
说明书 3 6 度膜 厚膜
4 11 硅油涂敷 硅油涂敷(Silicone
-coated)
5 倒6 聚氧乙烯 聚氧乙烯树脂
6 7 络合物 缔合物
7 2 羧甲基纤维素 羧甲基纤维素钠
10 6 25% 2.5%
11 倒5 20% 2.0%
13 倒6 20% 2.0%
Claims (10)
1、一种用于小割伤与创伤的那类胶粘绷带,由涂有压敏胶的衬底,固定于其上的吸收垫,垫上覆盖着的多孔塑料膜伤口防粘盖组成,对此绷带作的改进是:
在上述伤口防粘盖上有一个由分子量至少60万的聚氧乙烯构成的很薄的涂层,从而提高了上述胶粘绷带的止血效能。
2、权利要求1中的胶粘绷带,其中的聚氧乙烯分子量至少为400万。
3、权利要求2中的胶粘绷带,其中聚氧乙烯的附加重量是多孔塑料膜伤口防粘盖重量的1-10%。
4、权利要求3中的胶粘绷带,其中聚氧乙烯的附加重量是多孔塑料膜伤口防粘盖片重量的2-8%。
5、权利要求3中的胶粘绷带,其中的伤口防粘盖片由聚乙烯、聚丙烯或聚酯多孔塑料膜制成。
6、权利要求1至5中任何一项的无菌形式的胶粘绷带。
7、止血胶粘绷带由衬底材料、衬底材料一面上的压敏胶涂层、固定在衬底这一面上的吸收垫、垫上的多孔膜伤口防粘盖,以及在防粘盖外表面上的分子量至少为60万的聚氧乙烯薄涂层所组成。
8、用于小割伤与创伤的那类胶粘绷带,由盖有多孔塑料膜伤口防粘盖片的涂压敏胶的衬底组成,一种改进其止血效能的工艺包括:利用制造上述胶粘绷带的所有步骤,但另外在溶剂中溶解分子量至少为60万的聚氧乙烯,将该溶液涂在伤口防粘盖片上,蒸发掉溶剂,在伤口防粘盖上留下很薄的聚氧乙烯涂层。
9、权利要求8中的工艺,其中溶剂中溶解的聚氧乙烯浓度从0.5-6.5%。
10、权利要求9中的工艺,其中聚氧乙烯的浓度从1.0%至3.0%。
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-
1985
- 1985-06-14 US US06/744,829 patent/US4616644A/en not_active Expired - Lifetime
-
1986
- 1986-06-03 NZ NZ216403A patent/NZ216403A/xx unknown
- 1986-06-10 ES ES555921A patent/ES8900190A1/es not_active Expired
- 1986-06-10 JP JP61132884A patent/JPS61290952A/ja active Granted
- 1986-06-11 GR GR861515A patent/GR861515B/el unknown
- 1986-06-12 CA CA000511470A patent/CA1274733A/en not_active Expired - Lifetime
- 1986-06-13 ZA ZA864457A patent/ZA864457B/xx unknown
- 1986-06-13 MX MX2799A patent/MX163399B/es unknown
- 1986-06-13 PH PH33892A patent/PH23683A/en unknown
- 1986-06-13 IE IE861585A patent/IE861585L/xx unknown
- 1986-06-13 CN CN198686103931A patent/CN86103931A/zh active Pending
- 1986-06-13 AU AU58873/86A patent/AU587469B2/en not_active Expired
- 1986-06-13 IN IN443/CAL/86A patent/IN163517B/en unknown
- 1986-06-13 AT AT86304576T patent/ATE82143T1/de not_active IP Right Cessation
- 1986-06-13 DE DE8686304576T patent/DE3687088T2/de not_active Expired - Fee Related
- 1986-06-13 EP EP86304576A patent/EP0206697B1/en not_active Expired - Lifetime
- 1986-06-14 KR KR1019860004740A patent/KR950005335B1/ko not_active IP Right Cessation
-
1992
- 1992-12-18 SG SG1288/92A patent/SG128892G/en unknown
-
1993
- 1993-03-25 HK HK299/93A patent/HK29993A/xx not_active IP Right Cessation
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
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WO2016041443A1 (zh) * | 2014-09-18 | 2016-03-24 | 苏州安德佳生物科技有限公司 | 一种生物相容性止血制品及其制备方法 |
US10314937B2 (en) | 2014-09-18 | 2019-06-11 | Endoclot Plus Co., Ltd. | Biocompatible hemostatic product and preparation method thereof |
US11213615B2 (en) | 2017-02-28 | 2022-01-04 | EndoClot Plus Co.. Ltd | Composition for submucosal injection, reagent combination, and applications thereof |
US11998653B2 (en) | 2018-01-12 | 2024-06-04 | Beijing Universal Likang Technology Co., Ltd. | Method for treating active bleeding by sequentially applying a biocompatible hemostatic composition and a sealant composition |
Also Published As
Publication number | Publication date |
---|---|
CA1274733A (en) | 1990-10-02 |
SG128892G (en) | 1993-03-12 |
ZA864457B (en) | 1988-01-27 |
NZ216403A (en) | 1989-04-26 |
ES555921A0 (es) | 1989-03-16 |
EP0206697B1 (en) | 1992-11-11 |
ATE82143T1 (de) | 1992-11-15 |
AU587469B2 (en) | 1989-08-17 |
MX163399B (es) | 1992-05-11 |
DE3687088T2 (de) | 1993-04-08 |
US4616644A (en) | 1986-10-14 |
KR950005335B1 (ko) | 1995-05-23 |
HK29993A (en) | 1993-04-02 |
ES8900190A1 (es) | 1989-03-16 |
PH23683A (en) | 1989-09-27 |
JPH0588613B2 (zh) | 1993-12-22 |
EP0206697A3 (en) | 1988-09-21 |
JPS61290952A (ja) | 1986-12-20 |
DE3687088D1 (de) | 1992-12-17 |
AU5887386A (en) | 1986-12-18 |
IN163517B (zh) | 1988-10-01 |
KR870000058A (ko) | 1987-02-16 |
EP0206697A2 (en) | 1986-12-30 |
IE861585L (en) | 1986-12-14 |
GR861515B (en) | 1986-10-10 |
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