CN106110366B - 基于粘土的止血剂及其传递装置 - Google Patents
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- CN106110366B CN106110366B CN201610509518.7A CN201610509518A CN106110366B CN 106110366 B CN106110366 B CN 106110366B CN 201610509518 A CN201610509518 A CN 201610509518A CN 106110366 B CN106110366 B CN 106110366B
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Classifications
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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
- A61L15/18—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing inorganic materials
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Abstract
本发明涉及基于粘土的止血剂及其传递装置，具体涉及一种促进血液凝固的止血装置，其包括纱布衬底、分布于纱布衬底上的粘土材料，还有多元醇如丙三醇或类似醇，所述多元醇分布于纱布衬底上而与粘土材料结合。当该装置用于处理出血的伤口，至少有部分粘土材料与从伤口流出的血液接触造成凝血。一种可应用于流血伤口来促进血液凝固的绷带包括可变形的衬底和包埋于其中的纱布衬底。纱布衬底包括粘土材料和多元醇。一种止血海绵也包括纱布衬底和在衬底的第一表面上的止血材料和多元醇的分散相。
Description
本申请是申请号为200880005277.6，申请日为2008年3月6日，发明名称为“基于粘土的止血剂及其传递装置”的中国专利申请的分案申请。
技术领域
本发明一般地涉及用于促进止血的制剂和装置，更特别地，本发明涉及基于粘土的止血剂以及纳入了这种制剂而将其传递至伤口的装置。
背景技术
血液是一种液体组织，其包括分布在液相中的红细胞、白细胞、小体(corpuscle)以及血小板。该液相是血浆，其包括酸类、脂类、可溶电解质以及蛋白质。蛋白质悬浮在液相中，并且能够通过诸如过滤、离心、电泳以及免疫化学技术的多种方法中的任意方法从液相中将其分离。一种在液相中悬浮的特殊的蛋白质是纤维蛋白原。当发生出血时，纤维蛋白原与水以及凝血酶(一种酶)反应形成纤维蛋白，纤维蛋白不溶于血液并且聚合形成凝块。
在相当多的情况下，动物，包括人类，会受伤。这样的伤口常常会伴随出血。一些情况下，伤口和出血较轻微，正常的血液凝固功能，加上施以简单的急救就足够了。然而，不幸地是，在其它情况下会发生大出血。这些情况通常需要特别仪器和材料以及受过训练的人员来进行适当的救助。如果不能迅速地获得这样的救助，会发生过度失血。当出血严重时，有时立即可用的仪器以及受过训练的人员仍然不足以及时止住血流。
此外，严重创伤常常会在偏远地区或者在某种状况下发生，例如在战场上，此处不能立即获得充足的医疗救助。在这些情况下，甚至较不严重的创伤，长时间的止血足以允许伤员或者动物获得医治是非常重要的。
致力于解决上述问题，开发出一些材料以在不能获得常规救助或者比理想效果差的情况下控制过度出血。虽然这些材料已经显示出一定程度的成功，但这些材料有时对外伤不够有效或者太昂贵。此外，这些材料在一些状况下有时无效并且会难以应用且难以从伤口上移除。
另外，或者可选择地，以前开发出的材料能够产生非所需的副作用。例如，现有技术中的一类血液凝固材料一般是粉末或者细小颗粒，其中所述材料的表面在将其用于出血部位后常常产生放热反应。时常地，过多的材料不必要地倒至伤口上，这会加剧放热效应。取决于这些材料的特殊特性，由此产生的放热反应可足以造成不适甚至烧伤病人。虽然一些现有技术专利特别将由此产生的放热反应作为能对伤口产生类似于烧灼的凝血效应的预期特征陈述，然而在伤口部位的组织和其周围组织存在可能受到非所需的影响的可能。
此外，为了从伤口移除这些材料，常常需要冲洗伤口。如果施用的材料的量造成不适或者烧伤，伤口可能需要立即冲洗。在受伤的人或者动物还没有被运输到能够产生所需冲洗的机构的情况下，可能造成伤口的非所需的效果或者过度处理。
在手术过程中，出血也是一个问题。除了缝合和填塞切口或者体内出血部位外，出血常常通过海绵或者用于施加压力到出血部位和/或吸收血液的其它材料而控制。然而，当出血变得过量时，这些措施可能都不足以停止血流。此外，任何高度放热的出血控制材料可能损伤出血部位周围组织，并且可能没有设计为应用后易于移除。
基于以上内容，本发明的一般目的是产生一种止血剂，其克服或者改进了现有技术相关的缺点。本发明的一般目的还产生能够应用这样的止血剂的装置。
发明内容
根据一个方面，本发明在于产生促进血凝固因而能控制出血的装置。该装置包含颗粒形式的粘土材料和含有该粘土材料的容器。该容器的至少一部分被限定为有筛孔的筛网，这样做的目的是当该装置应用于出血部位时，粘土颗粒通过筛孔与血液接触。
根据另一个方面，本发明在于能够在出血的伤口上产生止血效应以控制血液从伤口流出的另一装置。该装置包含纱布衬底和分散于纱布衬底上的粘土材料。将该装置应用于出血的伤口上后，至少部分粘土材料与血液接触以造成止血效应。
根据另一个方面，本发明在于能在出血的伤口上应用以促进血凝固从而控制出血的绷带。这种绷带包含衬底、固定在衬底上的筛网，保留在筛网上的粘土材料颗粒。筛网由众多部分而限定出筛孔，筛孔能使血流进入筛网并进入粘土材料从而产生凝固效应。
根据另一个方面，本发明在于应用于出血的伤口上以使血液凝固并控制出血的止血海绵。这种海绵包含衬底，分布于衬底的第一表面上的止血材料，和分布于衬底的第二表面上的隔离剂。该隔离剂分布于衬底的伤口接触面以抑制海绵在凝块形成后粘附于伤口组织上。当处理出血伤口时，止血海绵的应用造成至少部分止血材料通过隔离剂和通过衬底与血液接触。
根据另一个方面，本发明在于其它形式的止血海绵。在这些形式中，止血海绵可包含薄膜和纳入薄膜中的止血材料；衬底，分布于衬底上的止血材料，和分布于止血材料之上的薄膜；或在两层衬底中夹着的止血材料。
根据另一个方面，本发明在于促进血液凝固从而控制出血的止血装置。该装置具有纱布衬底，分布于纱布衬底上的粘土材料，还有分布于纱布衬底上多元醇，如丙三醇或类似醇，以结合粘土材料。当该装置用于处理出血伤口时，至少部分粘土材料与从伤口流出的血液接触以造成凝固。
根据另一个方面，本发明在于能应用于出血的伤口上以使血液凝固从而控制出血的绷带。这种绷带具有可变形的衬底，和固定于其上的纱布衬底。该纱布衬底包括粘土材料和多元醇。当应用该绷带处理出血伤口时，将绷带应用于伤口造成至少部分粘土材料与从伤口流出的血液接触。
根据另一个方面，本发明在于止血海绵。一种类型的海绵具有纱布衬底和分布于该衬底的第一表面上的止血材料和多元醇。当该海绵用于处理出血伤口时，海绵的应用造成至少部分止血材料与血液接触。海绵的另一种类型具有第一和第二衬底。将止血材料分散于多元醇中，并将其应用于第一衬底，且将第二衬底置于分散于多元醇中的止血材料之上。当应用该海绵处理出血伤口时，将海绵应用于伤口造成至少部分止血材料通过至少一种衬底与血液接触。
本发明的一个优势是，不像其它材料如沸石，粘土成分与血液不产生放热效应。在伤口部位产热减少可用于减轻病人的不适和/或进一步损伤，并能特别用于处理某些病人如儿科或老年科病人，或当在特别敏感或精细部位处理伤口时使用。
另一个优势是，能将粘土精细地分开并使其沉淀在多种表面上，从而作为在多种出血控制装置上的成分促进它的应用。特别地，粘土能以颗粒形式应用(如保留在筛网或薄膜上)，或它能以粉末形式应用(如在纤维衬底上沉淀以形成纱布或绷带)。在任何具体实施方式中，粘土在伤口部位促进止血的效率相对于类似的仅能以一种形式应用的制剂(如像特定大小的颗粒)获得了改进，以限制如过度的放热反应的非所需的副作用。
本发明的另一个优势是能将本发明的装置和制剂容易地应用于开放伤口。特别是，当止血剂保留在筛网或类似装置内时，或当止血剂纳入针织结构形成纱布时，该装置能轻易地从灭菌包中取出，并直接将其放置或放在在血液流出的位点以形成凝块。
粘土(或任何其它止血剂)与多元醇(如丙三醇)一同应用的一个优势是抑制总是与粘土(或其它止血剂)相伴的粉尘。因其低挥发性，例如丙三醇，不会轻易地蒸发。因为它不会轻易地蒸发，所以当将粘土分散于丙三醇中时，粘土粉尘的产生减少。减少或抑制粉尘意味着更多的止血材料可用于血液凝固目的。
粘土(或其它止血剂)与多元醇一同应用的另一个优势是减少纱布与伤口的非所需的粘附。因此，纱布或其它装置能容易地从伤口上移除而不会使新形成的血凝块破裂。
附图说明
图1是本发明的血液凝固装置的筛网结构的示意图。
图2是图1的血液凝固装置的侧视图，示出了在筛网结构中保留的粘土颗粒。
图3是将粘土材料纳入纱布中的血液凝固装置的透视图。
图4是将粘土材料纳入布中的血液凝固装置的透视图。
图5A是筛网容器中纳入粘土颗粒的在出血伤口应用的绷带的透视图。
图5B是纱布衬底中纳入止血材料和多元醇的在出血伤口应用的绷带的透视图。
图6是具有止血性能的海绵的示意图。
图7是具有止血性能的海绵的另一具体实施方式的示意图。
图8是具有止血性能的海绵的另一具体实施方式的示意图。
图9是具有止血性能的海绵的另一具体实施方式的示意图。
具体实施方式
本文公开的是应用于出血伤口以促进止血的止血装置和止血剂。止血剂一般包括粘土材料或者其它基于硅石的材料，当其与出血伤口接触时，能够通过吸收至少部分液相血液而减少或者停止血流，从而促进凝固。本发明不限制于粘土，然而，像其它材料，例如生物活性玻璃、生物止血剂、分子筛材料、硅藻土、或者以上的混合物等，在本发明的范围内，并且能够作为止血剂与粘土一同应用或者单独应用。
如在本文中所应用，术语“粘土”是指含水的硅酸铝的晶体形式。粘土晶体是不规则形状并且不溶于水。几种类型的粘土与水混合可产生具有一定程度的可塑性的物质。取决于粘土的类型，其与水混合可产生具有触变性能的胶态凝胶。
在本发明的一个优选具体实施方式中，粘土材料是高岭土，其包括矿物“高岭石”。虽然术语“高岭土”在下文中用于描述本发明，也应理解高岭石还可以用于与高岭土结合或者代替高岭土。本发明也不限于高岭土或者高岭石，然而，其它材料在本发明的范围内。这些材料包括，但不限于，活性白土、膨润土，以上材料的组合、以上材料与高岭土和/或硅藻土的组合等。
如在本文中所应用，术语“高岭土”是指一种软的、土质的硅酸铝粘土(并且更特别地，是指一种二八面体(dioctahedral)页硅酸盐(phyllosilicate)粘土)，其具有化学式Al2Si2O5(OH)4。高岭土是自然发生的分层的硅酸盐矿物，其具有交替的矾土八面体的四面体片层(sheet)和八面体片层，片层通过羟基的氧分子连结。高岭土含有大约50％的矾土，大约50％的硅石和痕量杂质。
更优选是，粘土是艾德加(Edgar’s)可塑高岭土(下文用“EPK”表示)，这种粘土是水洗过的高岭土粘土，在佛罗里达的艾德加(Edgar)或在其附近开采和加工。艾德加可塑高岭土具有所需的可塑性特性，可成形，当与水混合时产生触变浆料。
本发明的高岭土材料可与其它物质混合，或另外与其它材料一同应用以产生额外的凝固功能和/或改进凝固效率。这种材料包括但不限于硫酸镁、偏磷酸钠、氯化钙、糊精、上述材料的组合、和上述材料的水合物。
各种材料可能是与高岭土混合，相伴，或纳入高岭土中以保持伤口部位的无菌环境或以产生与粘土的凝固功能补充的功能。能用的示例性的材料包括，但不限于，药学-活性成分如抗生素、抗真菌剂、抗微生物剂、抗炎制剂、镇痛剂、抗组胺剂(如西咪替丁、扑尔敏、盐酸苯海拉明和盐酸异丙嗪)、含银或铜离子的化合物、上述的组合等等。能纳入以产生额外的止血功能的其它材料包括抗坏血酸、氨甲环酸、芦丁和凝血酶。还可在伤口位点加入具有所需效应的植物制剂。
对于本发明的用途，高岭土(或其它粘土材料或硅藻土)优选颗粒形式。像本文所用的，“颗粒”包括珠、小丸、颗粒剂、棒或任何其它表面形貌或表面形貌的组合。无论表面形貌如何，颗粒约0.2mm(毫米)至约10mm，优选约0.5mm至约5mm，更优选是约1mm至约2mm的有效直径。本发明不限于这方面，然而，其它颗粒大小(例如，小于约0.2mm)也包含在本发明的范围内。高岭土(或其它粘土材料或硅藻土)的颗粒大小可能是非常小以至于被视为粉末。如果颗粒大小被认为是粉末，粉末可是细微的(即触觉检测不到)。
粘土颗粒能通过任何几个不同的方法产生。这些方法包括混合，挤压，球状化等。能用作使粘土混合、挤压、或球状化的设备可从在英国多塞特的Caleva ProcessSolutions Ltd获得。其它方法包括应用流体床或造粒装置。用于生产粘土颗粒的流体床可从新泽西州拉姆西的Glatt Air Technologies获得。用于生产粘土颗粒的盘状造粒装置可从威斯康星州绿湾的Feeco International,Inc.获得。优选地，粘土通过适当的挤压造粒设备挤出。本发明不限于在这方面，然而，如生产颗粒化的粘土的其它设备和方法包含在本发明的范围内。
本发明中用的EPK是颗粒化的，干燥的，并将其加热至约600℃。为了使EPK达到适当均匀混合以形成颗粒而应用合适的混合装置，将相对高的切应力应用于大块EPK。剪切之前，测量粘土的水含量并调整至约20重量％，以产生足够可用的混合物以将其挤压和进行随后的处理。
在将EPK加热至约600℃的过程中，将材料玻璃化。玻璃化作用是有效的，它通过反复的熔化和冷却循环使EPK(或其它粘土材料)转化成一种玻璃状物质。随着循环数增加，晶体结构破坏产生无定形成分。当随后将其浸湿时，EPK的无定形性质使其能够保持其结构的完整性。结果是，EPK在湿时应用保持其结构的完整性，例如，当应用于血液时。本发明不限于应用玻璃化的粘土，然而，由于尚未玻璃化的粘土材料依旧包含在本发明范围内。特别是，未经玻璃化的粘土仍然依旧能应用于出血的伤口以止血。
据信，当将粘土应用于出血时，粘土的细胞内凝固机制激活某些接触因子。更具体地说，据信高岭土(特别是EPK)通过将血液中的水吸收以促进凝固来启动机制。
现在来谈图1，图1显示止血装置的一个具体实施方式，其中纳入了颗粒形式的高岭土。该装置是一个透气袋，使液体进入，与保留其中的高岭土颗粒接触。密封的包装(未显示)对于存储止血装置直至应用产生了一个无菌的环境。该装置一般以10表示，且下文以“袋10”表示，该装置包括一个滤网或筛网12和由滤网或筛网保留在其中的颗粒化高岭土14。筛网12在所有各边是关闭的，并具有能够在其中保留颗粒化的高岭土14的筛孔，同时允许液体流过。如图所示，筛网12显示被抹平，而且通过举例的方式，只显示少数颗粒化的高岭土14的颗粒。将颗粒化的高岭土14与其它类型的粘土颗粒、硅藻土等混合以形成均匀的混合物。
筛网12由互连的丝、线或带的材料所限定。该丝、线或带能以任何一个或组合的方式互连，这些方式包括但不限于被织成纱布、交织、整体成形等。优选地，互连是使筛网能变形，同时实质上保持由此限定的筛孔的尺寸。来自丝、线或带的材料可被制造成聚合物(如尼龙、聚乙烯、聚丙烯、聚酯等)、金属、玻璃纤维、或有机物质(如棉、羊毛、丝绸等)。
现在来谈图2，通过筛网12限定筛孔的大小，以保留颗粒化高岭土14，但允许流动的血液通过。由于筛网12可在颗粒化高岭土14的周围拉紧，颗粒可通过筛孔延伸一个距离d。如果颗粒通过筛孔延伸，他们将直接与应用袋10的组织接触。因此，从组织流出的血液立即与颗粒化高岭土14接触，且其水相进入高岭土，从而促进血液凝固。然而，粒子从筛网中突出通过对于本发明不是必要的。
为了将袋10应用于出血伤口，将袋从包装中取出并将其放置在出血伤口上。筛网12中的颗粒化高岭土14与伤口组织接触和/或与从伤口流出的血液接触，且至少部分血液的液相被粘土材料吸收从而促进凝固。筛网12的变形性使得筛网可形成与出血伤口一致的形状并在应用后保持那个形状。
现在来谈图3，本发明止血装置的另一具体实施方式是一种高岭土纱布，一般是以20表示，且在下文中以“纱布20”表示。应用任何合适的方法将高岭土覆盖在纱布衬底上以制成纱布20。一个将高岭土覆盖在纱布衬底上的示例性的方法是将衬底在高岭土/水浆料中浸渍。用作浆料的高岭土材料优选是细土高岭土粉末，虽然本发明在这方面不限于高岭土颗粒，高岭土的絮片、晶片、珠、棒、颗粒剂等可选择性应用或额外再应用这些材料。纱布衬底可是任何合适的编织的或无纺布的纤维材料，其包括但不限于棉花、丝绸、羊毛、塑料、纤维素、人造丝、聚脂、上述材料的结合等。本发明不限于编织的或无纺布纤维材料用作纱布衬底，然而，如毡等也包含在本发明的范围内。
本发明所述的纱布20不限于高岭土，然而，其它粘土，如活性白土、膨润土，以及它们的组合可用来代替或补充高岭土。此外，其它硅基材料如生物活性玻璃，硅藻土，上述的结合等也可与上述任何粘土材料一同使用或者替代上述任何粘土材料。
一旦高岭土在纱布衬底上干燥以形成纱布20，纱布具有足够的可变形性以使纱布折叠，卷成卷儿，或以其它方式操作以将其包装。
纱布20衬底的可变形性使得纱布形成出血伤口的形状，并在应用后保留出血伤口的形状。
一种使覆盖在纱布衬底上高岭土(或其它粘土)沉淀的方式包括加热高岭土/浆料。优选地，将浆料加热至沸腾，因为较高的温度往往易于使高岭土粘附至衬底上。本发明不限于在这方面，然而，取决于高岭土涂层的所需特性，如可将浆料加热到较低温度。沸腾的浆料还产生了搅拌的有效形式，这种形式使高岭土均匀分散在液相。
然后将衬底在沸腾的浆料中沉浸很长时间，足以使高岭土沉淀到衬底上。鉴于湿高岭土和将纱布或衬底结合在一起的材料的流变学，高岭土可作为薄膜直接粘附于衬底表面，或也可能在丝的空隙内凝聚以及与丝本身凝聚，从而被固定在纤维基质内。
使覆盖在纱布衬底上高岭土沉淀的另一方式包括用喷涂技术，带槽模具技术，或其组合使浆料形式的高岭土应用于纱布衬底的另一面。应用任何技术，用于纱布衬底的浆料数量是有限的，以避免或至少降低衬底的饱和。优选地，用带槽模具技术，胶体形式的高岭土(或其它粘土)是用来产生稳定的粘度合适的悬浮物质以利于应用。
一旦喷涂或采用带槽模具技术，然后将涂层纱布衬底卷成卷儿或刮擦以进一步将高岭土嵌入衬底材料中。然后将纱布衬底干燥。
在一些具体实施方式，高岭土可用粘合剂附着在纱布衬底上。在应用粘合剂的具体实施方式中，粘合剂材料适合于生物组织。优选地，包括多元醇，壳聚糖，和聚乙烯醇，所有这些都具有粘着性质并适合于生物组织。至少壳聚糖表现出止血特性。
生产这种设备的一个示例性方法可包括将纱布打开卷的步骤，将纱布沉浸在止血材料和水的浆料中，通过在高压下滚动湿纱布，将压力加至纱布上以使止血材料纳入纱布材料内，使成卷的湿纱布干燥，并去除纱布中的粉尘(例如，用空气刀或空气喷嘴吹，通过应用静电能源，吸真空，或用直接接触的刷子刷)。在去除纱布中的粉尘后，纱布卷上朝下的纱布面可以是面对伤口的面，或者将其剪切成个别包装的纱布层。
为了优化保留在纱布中的高岭土的数量和完整性，可改变一个或多个变量。这些变量包括但不限于，浆料温度、浸泡时间、浆料搅拌方法，(浆料的)液体类型。提高浆料温度，如上文指出，有助于使高岭土保留在纱布上。搅拌可以通过迫使空气或其它气体通过喷嘴、搅动、起泡、煮沸、或超声波振动而起效。
用作浆料的液体也可是水之外的其它液体。例如，液体可是氨水溶液。已发现氨水溶液造成某些纤维材料的膨胀，如通常用于制造纱布的材料。
在一个纱布20中应用多元醇的具体实施方式中，多元醇可是丙三醇(也称为丙三醇(glycerin)、丙三醇(glycerine)、丙三醇剂(glyceritol)、丙三醇(glycyl alcohol)和根据其化学名称丙烷-1,2,3-三醇)。丙三醇是滑的，吸湿性和水溶性液体，与生物组织相容。将高岭土分散于丙三醇中以形成分散相或与丙三醇混合的其它方式，并应用任何合适的方法将其沉积到纱布衬底上。将高岭土/丙三醇分散相沉淀到纱布衬底上的适当方式包括，但不限于，喷洒分散相，在分散相中浸泡纱布衬底，通过带槽模具技术应用，如粉刷或将分散相轧在纱布上等的物理手段。
本发明不限于应用丙三醇，然而，像其它基于丙三醇的化合物，包括丙三醇基醇(如丙二醇)、基于丙三醇的酯化脂肪酸(如丙三醇三醋酸酯)和具有保湿剂性能的其它材料等(以及上述的组合)在本发明的范围内。此外，其它多元醇如山梨醇、木糖醇、麦芽醇，上述的组合等以及聚合多元醇(如聚葡萄糖)也在本发明的范围内。
现在谈及图4，本发明的止血装置的另一具体实施方式是一种具有止血特性的布，一般以20表示，在下文中将这种布称为“布30”。布30是一种由针织或非针织的丝或毡所限定等的织物，生物止血材料注入或浸渍到所述织物中。可被注入或浸渍到布30的织物内的止血材料包括，但不限于颗粒32形式的粘土(如高岭土)，其它硅基材料(如硅藻土及其组合或相似的材料)、壳聚糖、上述的组合等等。在将这些材料注入或浸渍至布内的具体实施方式中，优选材料是在水合状态纳入布内并随后使之干燥。
在纱布或布的具体实施方式中，纱布或布的材料可是与多糖类或相似材料交联在一起的。
现在谈及图5A，本发明的另一具体实施方式是绷带，以50表示，其包含颗粒化高岭土14(或一些其它粘土材料或硅藻土)，这些材料保留在筛网12内并包埋在可变形的能用于伤口上的衬底52中(例如，使用压力敏感性粘合剂，将绷带50粘合至应用者的皮肤)。筛网12是缝在、粘在或以其它方法包埋至衬底52上以形成绷带50。
衬底52是一种塑料或布成分，其有利于被保留在受伤的人或动物的皮肤的出血伤口上或出血伤口的附近。粘合剂54分布在衬底52的表面，其使受伤的人或动物的皮肤吻合。特别是，如果衬底52是一个非透气的塑料材料，衬底可包括孔56，以使皮肤表面蒸发的湿气散发。
现在谈及图5B，绷带的另一具体实施方式以150表示。绷带150包括分散在丙三醇中的和用于纱布衬底112的颗粒化高岭土(或一些其它能够发挥凝血功能的粘土材料或硅藻土)。纱布衬底112包埋至能用于伤口上的可变形的衬底152上(例如，使用压力敏感性粘合剂154将绷带150粘合至应用者的皮肤，所述粘合剂154实质上分布于可变形的衬底152的所有接触皮肤的表面)。将纱布衬底112缝在、粘在或包埋至衬底152上，衬底152可是一种包括孔156的塑料或布。隔离剂(如聚乙烯醇、丙三醇、羧甲基纤维素等)可在纱布衬底112上的高岭土/丙三醇分散相遍布分布。
现在谈及图6，本发明的另一种具体实施方式是一种海绵，以60表示，其包括衬底62，分布在衬底62的一面的颗粒化高岭土14(或其它粘土材料或硅藻土)和分布在衬底的相对面的隔离剂64。海绵60使得颗粒化高岭土14与伤口流出的血液充分地接触并通过隔离剂64和衬底62，同时减少海绵粘附在伤口组织上。海绵60也与活体组织相容。
衬底62是吸附性纱布材料，其限定一种基质。本发明不限于此，然而，像其它材料，如人造丝/聚酯纤维素混纺等类也在本发明的范围内。可制造衬底62的其他材料包括针织布、无纺布、纸(例如，牛皮纸等类)和纤维素材料(例如，棉球，棉签形式的棉等)。任何可制造衬底62的材料可具有弹性。当将弹性材料作为衬底62时，海绵60成为止血装置也是压力绷带，特别是在加上表面粘合性试剂，或机械紧固件以使海绵固定在伤口上方的位置的具体实施方式中。
用在海绵60中的止血剂并不限于颗粒化高岭土14。其它材料如活性白土、膨润土、上述的组合，或可用上述材料与高岭土的组合。本发明还不限于粘土，像其它材料，如生物活性玻璃、生物止血剂、硅藻土、及其组合、上述材料与粘土的组合也在本发明的范围内。
颗粒化高岭土14可与衬底62经库仑力结合在一起，这种结合是通过浸渍或其它方式把粘土或其它止血材料直接纳入至衬底材料上，通过应用粘合剂，通过将止血材料捕获在基质或同类物质中。
当应用粘合剂将颗粒化高岭土14粘结至衬底62上，粘合剂材料可对海绵60产生额外的功能。可制造粘合剂的材料包括，但不限于壳聚糖、聚乙烯醇、瓜尔豆胶、胶凝淀粉、多糖、纤维素、海藻酸钙等，以及上述组合。
在颗粒化高岭土14直接纳入衬底62的具体实施方式中，颗粒化高岭土可能会在衬底制造过程中纳入。如果衬底是一种含有人造丝和聚酯的非制造纱布材料，那么将颗粒化高岭土14纳入人造丝和聚酯纤维之内或之上。例如，颗粒化高岭土14可是粉末状，并应用于融化聚酯，且聚酯纤维可从融化的聚酯/止血材料提取。如果衬底是织纱(如棉)，可将粉末形式的高岭土14在纺线过程中纳入棉线内。
也可将颗粒化高岭土14分散在丙三醇内并通过喷雾技术，带槽模具技术(a slotdie technique)、浸泡、刷涂、轴轧(rolling)或类似技术应用于衬底62上。
隔离剂64是一种分布在衬底62的伤口接触面上，以在血凝块形成后，使海绵60易于从伤口组织去除的材料。隔离剂64可是连续的薄膜，它也可以是衬底表面的不连续的薄膜。一种可作为隔离剂的材料是聚乙烯醇，这是一种生物兼容性材料，可形成薄膜，并且没有严重影响海绵60的吸水性和液体渗透性。另一种可用作隔离剂64的材料是丙三醇，它除了可使颗粒化高岭土14分散在其中之外也可用作隔离剂64。当用作隔离剂64时，丙三醇遍布颗粒化高岭土14在丙三醇中的分散相形成薄膜。可以用来作为隔离剂的其它材料包括但不限于羧甲基纤维素。在任何结构的海绵60中，隔离剂64可直接应用于衬底62的伤口接触表面。
可选择地，隔离剂64可作为粘土浆料和隔离剂应用于衬底62的非伤口接触表面。在这种具体实施方式中，聚乙烯醇或丙三醇的浓度是使至少其一些醇成分渗进衬底62的伤口接触表面的浓度，而同时粘土材料依然保留在非伤口接触表面之上或附近。在任何具体实施方式中，聚乙烯醇或丙三醇不仅作为隔离剂，而且作为抑制颗粒化高岭土14的粉尘的药剂。
本发明范围内的可用作隔离剂的其它材料包括，但不限于，硅酮和胶凝淀粉。如聚乙烯醇和丙三醇一样，可以薄膜形式应用硅酮或胶凝淀粉。
海绵60可进一步包括一个成分，其赋予海绵以透不过辐射的特性。在这种具体实施方式中，可将硫酸钡纳入包括颗粒化高岭土14的浆料中，并应用于衬底62。
海绵60可进一步包括水或醇，从而可将海绵用作擦拭子。
现在来谈图7，海绵的另一具体实施方式一般以160表示。海绵160包含薄膜162和分散于其中的颗粒化高岭土14。海绵160的物理完整性是通过薄膜162维持的。优选地，制造的薄膜162的材料是聚乙烯醇。在制造海绵160过程中，将颗粒化高岭土14分散到聚乙烯醇中，然后形成薄层。海绵160在将其纳入绷带后特别有用。
现在来谈图8，海绵的另一个具体实施方式一般以260表示。海绵260包含衬底262，颗粒化高岭土14分布于该衬底上，和沿止血材料分布的薄膜266。颗粒化高岭土14是非结合的(无粘合剂)血液凝结剂，并优选将其成贴地分布于衬底262上，以促进海绵260的折叠。薄膜266是聚乙烯醇，丙三醇等，并且是既用于包入颗粒化高岭土14，也用于减少粉尘的产生。在将其用于出血的伤口后，从伤口流出的血被吸收至衬底262内并与颗粒化高岭土14接触。
现在来谈图9，海绵的另一具体实施方式一般以360表示。海绵360包括夹在两层衬底362中的颗粒化高岭土14。能将衬底362以任何适当的方式，如通过将选择性不含颗粒化高岭土14的区域热封，在被选区域应用粘性物或粘合剂，沿整个海绵360应用抑制性薄膜材料(如聚乙烯醇)，或组合应用任何上述材料。颗粒化高岭土14还能用来与丙三醇配合使用，如将其分散在丙三醇中并用于海绵360。
可以各种方式折叠和应用海绵60(以及以160、260和360表示的海绵)。可将海绵60如此折叠以至于颗粒化高岭土14分散的表面分布于折叠海绵的内侧表面，以减少粉尘问题和使止血材料从衬底62上脱离。也可将海绵60(和海绵160、260和360)折叠成有褶的形式，或折叠成沿边缘产生一些不同的层的构型。通过这种方式使海绵60产生构型，能满足不同应用对顺应性和吸收性的需要。也可将海绵60剪成或使之形成伸展的贴，以包扎在受伤的人或动物的伤口上或供加在量筒或拭子内使用。为了方便使用，也可将海绵60剪成、撕成或磨成小片，或以其它方式使之形成小片，如将其填充到筛网容器中。
实施例1-浆料的温度对棉布纱布保留高岭土能力的影响
高岭土/水的浆料的温度多种多样，以评价布纱布保留高岭土的能力。准备水和EPK的浆料，其中高岭土是浆料的总重量的40％。将棉布纱布浸入不同温度的浆料中，将湿海绵在压力下卷成卷儿并使之干燥，从而制成三种海绵(一种来自一块纱布)。下面的表格显示每种浆料的参数和取得的结果。
最后纱布重量是卷成卷儿和干燥后的纱布的重量。应注意，浆料温度升高使保留的高岭土的数量增加。对此的一种说法是，通过将其浸在热的液体中而使因为纱布的棉纤维结构变松并膨胀。
实施例2–干高岭土应用于干棉布纱布以形成止血装置
将干高岭土应用于干燥棉布纱布。然后将纱布卷成卷儿来。保留纱布上的高岭土的数量明显显著地少于保留在纱布样品3(实施例1)中的高岭土。该样品，然而，使绵羊全血的凝结时间比未加速的血液凝结时间加快70％以上。
实施例3–用丙三醇减少高岭土粉尘
制备含50克(g)水、20克丙三醇、15克高岭土粉末的浆料，并用于使纱布海绵(Kendall Curity 2733)饱和。使饱和的纱布海绵干燥。拿着海绵，并沿一个干净的玻璃表面用铅笔轻叩。视觉检测表明，轻叩造成没有易辨的灰尘从海绵中流出。
制备第二种不含丙三醇的海绵并使之干燥。拿着第二种海绵并用铅笔在一个干净的玻璃表面轻叩。视觉检测表明，轻叩造成大量的高岭土粉尘从第二种海绵中掉出。
虽然在其详细具体实施方式方面已经表明和描述了这项发明，本领域技术人员应理解，各种变化和其成分可被等价物取代并未偏离本发明的范围。此外，为适应特定情况或材料而对本发明的方案所做的修改并未偏离本发明的基本范围。因此，本发明不限于上文的详细描述中所公开的特定的具体实施方式，本发明还包括所有所附的权利要求的范围内的具体实施方式。
Claims (15)
1.一种用于在出血伤口产生止血效果的装置，所述装置包含：
衬底；
分布于所述衬底上的基于高岭石的止血剂；和
分布于所述衬底上的将所述基于高岭石的止血剂结合于所述衬底的粘合剂；
其中所述粘合剂选自纤维素、海藻酸钙和丙三醇；
其中在将所述基于高岭石的止血剂和所述粘合剂分布于所述衬底后，所述衬底、所述基于高岭石的止血剂、和所述粘合剂经历干燥过程；
其中所述衬底与所述基于高岭石的止血剂最初分开存在；
其中所述粘合剂减少高岭土粉尘的产生；且
其中当处理出血的伤口时，所述装置的应用造成至少部分所述基于高岭石的止血剂与血液接触。
2.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述衬底是纱布衬底。
3.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述粘合剂是丙三醇。
4.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述粘合剂是海藻酸钙。
5.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述粘合剂是纤维素。
6.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述衬底能够变形以使所述衬底形成所述出血伤口的形状并保持所述出血伤口的形状。
7.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述基于高岭石的止血剂进一步包含选自抗生素、抗微生物剂、抗炎剂、镇痛剂、抗组胺剂、含有银或铜离子的化合物的药学活性组分和上述组分的组合。
8.根据权利要求1所述的用于在出血伤口产生止血效果的装置，其中所述衬底由选自棉、丝、毛、塑料、纤维素、人造丝、聚酯和上述的组合的材料制造。
9.一种用于在出血伤口产生止血效果的装置，所述装置包含：
衬底；
分布于所述衬底上的基于粘土的止血剂；和
选自纤维素和海藻酸钙的粘合剂，所述粘合剂分布于所述衬底上，将所述基于粘土的止血剂结合于所述衬底；
其中在将所述基于粘土的止血剂和所述粘合剂分布于所述衬底后，所述衬底、所述基于粘土的止血剂、和所述粘合剂经历干燥过程；
其中所述衬底与所述基于粘土的止血剂最初分开存在；且
其中当处理出血的伤口时，所述装置的应用造成至少部分所述基于粘土的止血剂与血液接触。
10.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述衬底是纱布衬底。
11.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述基于粘土的止血剂包括粘土，所述粘土选自活性白土、膨润土、高岭土和上述材料的组合。
12.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述基于粘土的止血剂是高岭土。
13.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述衬底能够变形以使所述衬底形成所述出血伤口的形状并保持所述出血伤口的形状。
14.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述基于粘土的止血剂进一步包含选自抗生素、抗微生物剂、抗炎剂、镇痛剂、抗组胺剂、含有银或铜离子的化合物的药学活性组分和上述组分的组合。
15.根据权利要求9所述的用于在出血伤口产生止血效果的装置，其中所述衬底由选自棉、丝、毛、塑料、纤维素、人造丝、聚酯和上述的组合的材料制造。
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Patent Citations (4)
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| GB548046A (en) * | 1941-02-19 | 1942-09-23 | Walter Sim Harris | Improvements in or relating to lint, bandages, gauze, cotton wool and other surgicaldressings and bindings |
| GB1155440A (en) * | 1966-01-18 | 1969-06-18 | Herman Ferdinand Kamp | Therapeutic Composition for Treating Skin Injuries |
| WO2005030279A1 (en) * | 2003-09-29 | 2005-04-07 | Le Groupe Lysac Inc. | Polysaccharide phyllosilicate absorbent or superabsorbent nanocomposite materials |
| WO2006088912A2 (en) * | 2005-02-15 | 2006-08-24 | Virginia Commonwealth University | Mineral technologies (mt) for acute hemostasis and for the treatment of acute wounds and chronic ulcers |
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