CN101541274B - 基于粘土的止血剂及其输送装置 - Google Patents

基于粘土的止血剂及其输送装置 Download PDF

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CN101541274B
CN101541274B CN200780039308.5A CN200780039308A CN101541274B CN 101541274 B CN101541274 B CN 101541274B CN 200780039308 A CN200780039308 A CN 200780039308A CN 101541274 B CN101541274 B CN 101541274B
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R·休伊
D·洛
D·J·伯恩斯
G·巴萨多那
F·X·赫西
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Abstract

一种用于促进血液凝结的装置包括微粒形式的粘土材料和用于容纳粘土材料的容器。容器的至少部分通过网限定。另一种装置包括纱布基底和布置在纱布基底上的粘土材料。另一种装置是绷带，包括基底、安装在基底上的网和保持在网内的粘土材料微粒。一种止血海绵包括基底、布置在基底的第一表面上的止血材料、和布置在基底的第二表面上的释放剂。释放剂布置在基底的创伤接触表面上。当处理出血创伤时，止血海绵的应用导致止血材料的至少部分与通过释放剂和通过基底的血液接触。

Description

基于粘土的止血剂及其输送装置
相关申请的交叉引用
本申请要求2006年10月30日提交的美国专利申请No.11/590,427的优先权，该专利申请与如下申请相关：2006年5月26日提交的名为“BloodClotting Compound”的美国临时专利申请No.60/808,618；2006年6月1日提交的名为“Hemostatic Device with Oxidized Cellulose Pad”的美国临时专利申请No.60/810,447；2006年10月6日提交的名为“HemostaticCompositions and Method of Manufacture”的美国专利申请律师卷号No.6989-0067；和2006年10月20日提交的名为“Devices and Methods for theDelivery of Hemostatic Agents to Bleeding Wounds”的美国专利申请律师卷号No.6989-0069；所有以上引用的申请的内容通过引用全部包含在此。
技术领域
本申请总地涉及用于促进止血的制剂和装置，且更具体地涉及基于粘土的止血剂和合并这样的制剂以用于将其输送到出血创伤处的装置。
背景技术
血液是液体组织，它包括散布在液体相内的红细胞、白细胞、血球和血小板。液体相是血浆，血浆包括酸、脂质、溶解的电解质和蛋白质。蛋白质悬浮在液体相内且能够通过例如过滤、离心、电泳和免疫化学技术的多种方法中的任何方法从液体相分离。悬浮在液体相内的一种特别的蛋白质是纤维蛋白原。当发生出血时，纤维蛋白原与水和凝血酶(酶)反应以形成纤维蛋白，该纤维蛋白在血液中是不可溶的且聚合以形成凝块。
在多种场合中动物(包括人类)可能受伤。出血经常与这样的创伤相关。在一些场合中，创伤和出血是轻微的，除施加简单急救外仅要求常规的凝血功能。然而，不幸的是在其他场合中可能发生大量出血。这些情况通常要求专用设备和材料以及专业受训人员来实施合适的救助。如果这样的救助不容易获得，则可能发生过量的失血。当出血严重时，有时设备和专业受训人员的立即就位仍不足以以及时方式停止流血。
此外，严重的创伤经常可能在遥远的区域或在不能立刻获得充分医疗帮助的情况(例如战场)中发生。在这些情形中，即使在不很严重的创伤中，重要的是停止出血足够长时间以允许伤员或受伤动物接受医疗处理。
在解决以上所述的问题的努力中，已开发了用于在常规救助不能获得或不最佳有效的情况中控制过量出血的材料。虽然这些材料已表现略有成功，但它们有时对于外伤创伤不足够有效，且趋向于昂贵。此外，这些材料有时在一些情况中无效，且可能难于施加以及难于从创伤处移除。
附加地或替代地，先前开发的材料能够产生不希望的副作用。例如，一种类型的现有技术的凝血材料一般地是粉末或细小的微粒，其中在将材料施加到血液时，材料的表面区域经常产生放热反应。时常将过多的材料不必要地倾倒在创伤上，这能够加剧放热效果。取决于材料的具体属性，由此引起的放热可能足以导致患者不适或甚至灼伤患者。虽然一些现有技术的专利特别地陈述由此引起的放热是希望的特征，该放热能够为创伤提供类似于烧灼的凝血效果，但存在位于和围绕创伤位置的组织可能不希望地被影响的可能性。
此外，为从创伤移除这样的材料，经常要求冲洗创伤。如果给予的材料量导致不适或灼伤，则可能要求立即清洗创伤。在伤员或受伤动物尚未输送到能够提供所需冲洗的设施的情形中，可能导致创伤的不希望的效果或过处理。
出血也能够是外科过程期间的问题。除缝合或封缝切口或内部出血区域外，经常使用用于在出血位置上施加压力和/或吸收血液的海绵或其他材料来控制出血。然而，当出血过多时，这些措施可能不足以停止血流。此外，任何高放热的出血控制材料可能损害围绕出血位置的组织且可能不被构造为在使用后简单移除。
基于前述描述，本发明的总的目的是提供克服或改进与现有技术相关的缺点的止血剂。本发明的总的目的也是提供能够应用这样的止血剂的装置。
发明内容
根据一个方面，本发明涉及一种用于促进血液凝结而因此控制出血的装置。装置包括微粒形式的粘土材料和用于容纳粘土材料的容器。容器的至少部分通过其中具有开口的网限定，使得当装置应用在出血位置时，粘土的微粒与通过开口的血液接触。
根据另一个方面，本发明涉及能够提供对出血创伤的止血作用以控制从创伤流血的另一种装置。装置包括纱布基底和布置在纱布基底上的粘土材料。当装置应用于出血创伤时，粘土材料的至少部分与血液接触以导致止血作用。
根据另一个方面，本发明涉及能够应用到出血创伤以促进血液凝结因此控制出血的绷带。绷带包括基底、安装在基底上的网和保持在网内的粘土材料的微粒。网通过多个设置为限定开口的构件限定，开口允许血液流入网内且流入粘土材料内，因此产生凝结效果。
根据另一个方面，本发明涉及能够应用到出血创伤以凝结血液且控制出血的止血海绵。这样的海绵包括基底、布置在基底的第一表面上的止血材料和布置在基底的第二表面上的释放剂。释放剂布置在基底的创伤接触表面上，以抑制凝块形成后海绵附着到创伤组织。当处理出血创伤时，止血海绵的应用导致止血材料的至少部分与通过释放剂且通过基底的血液接触。
根据再另一个方面，本发明涉及止血海绵的其他形式。在这样的形式中，止血海绵可以包括膜和合并到膜内的止血材料；基底，布置在基底上的止血材料和布置在止血材料上方的膜；或夹在两个基底之间的止血材料。
本发明的优点是，与例如沸石的其他材料不同，粘土成分不产生与血液的放热反应。消除在创伤位置处的热的产生在最小化对于患者的不适和/或进一步伤害方面是有用的，且在例如幼儿或老年患者的某些患者处理中或当被处理的创伤处于特别敏感或脆弱的区域时可以是特别地有用的。
另一个优点是粘土能够被精细地分开且沉积在多个表面上，因此便于用作多种血液控制装置的部件。特别地，粘土能够以微粒形式使用(例如保持在网内或膜内)，或粘土能够以粉末形式使用(例如沉积在纤维基底上以形成纱布或海绵)。在任何实施例中，粘土对于促进创伤位置处止血的效用与能够仅以一种形式使用(例如作为特定尺寸的微粒)的类似的制剂相比被改进，以限制例如过度放热反应的不希望的副作用。
本发明的再另一个优点是本发明的装置和制剂容易应用到开放的创伤。特别当止血剂保持在网内或类似的装置内时，或当止血剂合并到织造结构内以形成纱布时，装置能够容易地从无菌包装中移出且直接放置或保持在出血点处以导致凝结。
附图说明
图1是本发明的凝血装置的网结构的示意性表示；
图2是图1的凝血装置的侧视图，图示将粘土微粒保持在网结构内；
图3是将粘土材料合并到纱布内的凝血装置的透视图；
图4是将粘土材料合并到布内的凝血装置的透视图；
图5是将粘土微粒合并到网容器内用于应用到出血创伤的绷带的透视图；
图6是具有止血能力的海绵的示意性表示；
图7是具有止血能力的海绵的另一个实施例的示意性表示；
图8是具有止血能力的海绵的另一个实施例的示意性表示；
图9是具有止血能力的海绵的另一个实施例的示意性表示。
具体实施方式
在此公开了可应用于出血创伤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其他基于二氧化硅的材料，当它们与出血创伤接触时能够通过吸收血液的液体相的至少部分来最小化或停止流血，因此便于凝结。然而，本发明不限制于粘土，因为例如生物活性玻璃、生物止血剂、分子筛材料、硅藻土以及前述材料的组合等的其他材料在本发明的范围内，且能够与粘土组合使用或分开地作为止血剂使用。
如在此所使用，术语“粘土”指水合硅酸铝的晶体形式。粘土晶体是不规则成形的且不可溶解于水。一些类型的粘土与水的组合可以产生具有一些程度塑性的团块。取决于粘土的类型，其与水的组合可以产生具有触变特性的胶态凝胶。
在本发明的一个优选实施例中，粘土材料是包括矿物“高岭石”的高岭土。虽然术语“高岭土”在下文中用于描述本发明，但应理解的是高岭石也可以与高岭土组合使用或替代高岭土使用。然而，本发明也不限制于高岭土或高岭石，因为其他材料也在本发明的范围内。这样的材料包括但不限制于绿坡缕石、斑脱土、前述材料的组合以及前述材料与高岭土和/或硅藻土的组合等。
如在此所使用的，术语“高岭土”指柔软的土质铝硅酸盐粘土(且更具体地指二八面体型层状硅酸盐(phyllosilicate)粘土)，其化学式为Al2Si2O5(OH)4。高岭土是天然存在的层状硅酸盐矿物，它具有经由羟基的氧原子链接的氧化铝八面体的交替的四面体片和八面体片。高岭土包括大约50％的氧化铝、大约50％的二氧化硅和痕量杂质。
更优选地，粘土为Edgar塑性高岭土(在下文中称为“EPK”)，其是在Edgar，Florida处和附近开采和处理的水洗高岭粘土。Edgar塑性高岭土具有希望的塑性特征，是可铸的，且在与水混合时产生触变浆料。
本发明的高岭土材料可以与其他材料混合或另外地与其他材料组合使用，以提供另外的凝结功能和/或改进的效力。这样的材料包括但不限制于硫酸镁、偏磷酸钠、氯化钙、糊精、前述材料的组合和前述材料的水合物。
多种材料可以与高岭土混合、结合或合并到高岭土内，以维持创伤位置处的消毒环境或提供补充粘土凝结功能的功能。能够使用的典型材料包括但不限制于药物活性组分，例如抗生素、抗真菌剂、抗菌剂、消炎剂、止痛剂、抗组胺剂(例如甲氰咪胍、马来酸氯苯那敏、盐酸苯海拉明和盐酸异丙嗪)、含有银或铜离子的化合物、前述材料的组合等。能够合并以提供另外的止血功能的其他材料包括抗坏血酸、氨甲环酸、芸香苷和凝血酶。也可以添加对于创伤位置具有希望的效果的植物制剂。
为在本发明中使用，高岭土(或其他粘土材料或硅藻土)优选地是微粒形式。如在此所使用，“微粒”包括珠、小球、细粒、棒或任何其他表面形态或表面形态的组合。与表面形态无关，微粒的有效直径为大约0.2mm(毫米)至大约10mm，优选地大约0.5mm至大约5mm，且更优选地大约1mm至大约2mm。
粘土微粒能够通过数种不同方法中的任何方法生产。这样的方法包括混合、挤出、球化等。能够用于混合、挤出或球化粘土的设备从位于Dorset，United Kingdom的Caleva Process Solution Ltd.可获得。其他方法包括使用流体床或造粒仪器。用于生产粘土微粒的流体床从位于Ramsey，NewJersey的Glatt Air Technologies可获得。用于生产粘土微粒的盘式造粒机从位于Green Bay，Wisconsin的Feeco International Inc.可获得。优选地，粘土通过合适的造粒装置挤出。然而，本发明不限制于此，因为用于生产微粒化粘土的其他装置和方法在本发明的范围内。
在本发明中使用的EPK被微粒化、干燥且烧制到大约600℃。为获得合适地均匀的EPK混合物以形成微粒，使用合适的混合仪器将相对高的剪力施加到EPK的团块。在剪切前，测量粘土的含水量且将其调整到重量百分比大约20％，以给出充分地可工作的混合物用于挤出和随后的处理。
在EPK烧制到大约600℃期间，材料被玻璃化。玻璃化通过重复的熔融和冷却循环实现，以允许EPK(或其他粘土材料)转化为玻璃物质。随着循环次数的增加，晶体结构被打破以导致非晶组分。EPK的非晶属性允许它在随后的湿化时维持其结构完整性。作为结果，EPK在使用期间湿化时，例如当施加到血液时，维持其结构完整性。然而，本发明不限制于使用玻璃化粘土，因为未玻璃化的粘土材料仍在本发明的范围内。特别地，非玻璃化粘土仍能够施加到出血创伤以提供止血。
被认为当施加粘土到血液时，粘土的细胞凝结机制激活一定的接触因子。更具体地，被认为高岭土(特别是EPK)引起了吸收血液中水以便于凝结功能的机制。
现在参考图1，图中示出止血装置的一个实施例，微粒形式的高岭土合并到该止血装置内。装置是允许液体进入以接触保持在其内的高岭土微粒的可渗透袋。密封的包装(未示出)提供无菌环境用于存储止血装置，直至止血装置能够被使用。总地以10示出的且在下文中称为“袋10”的装置包括筛或网12和通过筛或网保持在其内的微粒化高岭土14。网12在所有侧上封闭且限定能够将微粒化高岭土14保持在其内同时允许液体流过的开口。如所图示，网12示出为被展平，且通过示例的方式，仅示出一些微粒化高岭土14的微粒。微粒化高岭土14可以与其他类型的粘土、硅藻土等的微粒混合以形成均匀混合物。
网12通过材料的相互连接的束、丝或条限定。束、丝或条能够以任一种方式或以方式组合来相互连接，所述方式包括但不限制于织造为纱布、缠结、整体形成等。优选地，相互连接使得网能够弯曲，同时大体上维持由此而限定的开口的尺寸。制造束、丝或条的材料可以是聚合物(例如，尼龙、聚乙烯、聚丙烯、聚酯等)、金属、玻璃纤维或有机物质(例如，棉、毛、丝等)。
现在参考图2，由网12限定的开口定尺寸为保持微粒化高岭土14但允许血液流过。因为网12可以围绕微粒化高岭土14被拉紧，所以微粒可以延伸通过开口以距离d。如果微粒延伸通过开口，则微粒将直接接触袋10所靠着应用的组织。因此，从组织流出的血液立即接触微粒化高岭土14，且血液的水相被芯吸入高岭土内，因此便于血液的凝结。然而，本发明不要求微粒突出通过网。
为将袋10应用到出血创伤，将袋从包装中移出且放置在出血创伤上。网12内的微粒化高岭土14接触创伤组织和/或从创伤流出的血液，且血液的液体相的至少部分被粘土材料吸收，因此促进凝结。网12的柔性允许网顺应出血创伤的形状且在应用时保持此形状。
现在参考图3，本发明的止血装置的另一个实施例是高岭土纱布，该高岭土纱布总地以20示出且在下文中称为“纱布20”。使用任何合适的方法将高岭土涂敷在纱布基底上以得到纱布20。将高岭土涂覆到纱布基底上的一种典型的方法是将基底浸入高岭土/水浆料中。用于浆料的高岭土材料优选地是精细研磨的高岭土粉末，但本发明不限制于此，因为高岭土微粒、薄片、碎屑、珠、棒、小粒等可以替代地或另外地使用。纱布基底可以是任何合适的织造或非织造纤维材料，包括但不限制于棉、丝、毛、塑料、纤维素、人造纤维、聚酯、前述材料的组合等。然而，本发明不限制于织造或非织造纤维材料作为纱布基底，因为毡等也在本发明的范围内。
然而，本发明的纱布20不限制于高岭土，因为例如绿坡缕石、斑脱土、绿坡缕石和斑脱土的组合的其他粘土可以作为高岭土的替代或除高岭土外又使用。此外，其他基于二氧化硅的材料，例如生物活性玻璃、硅藻土、前述材料的组合等也可以除任意前述粘土材料外又使用或替代任意前述粘土材料使用。
在任何实施例中，一旦高岭土在纱布基底上被干燥以形成纱布20，则纱布是充分柔性的，以允许纱布被折叠、卷绕或另外地操作以用于包装。
纱布20的基底的柔性允许纱布形成出血创伤的形状，且在应用时保持出血创伤的形状。
将高岭土(或其他粘土)涂层沉积在纱布基底上的一种方式包括将高岭土/水浆料加热。优选地，浆料被加热到沸腾，因为更高的温度趋向于便于使高岭土附着到基底。然而，本发明不限制于此，因为取决于高岭土涂层的希望的特征，浆料可以被加热到较低的温度。使浆料沸腾也提供有效的搅动形式，这使得高岭土均一地散布在液体相内。
然后基底浸入沸腾的浆料内足以导致高岭土沉积在基底上的时间量。假定湿润的高岭土和用其制造纱布或基底的材料的流变能力，则高岭土可以作为膜直接附着到基底表面，或高岭土可以聚集在束的空隙内以及沿束自身聚集，因此被收集在纤维基体内。
将高岭土涂层沉积在基底上的另一种方式包括使用喷射技术、狭缝式涂布技术或其组合将高岭土以浆料形式施加在纱布基底的一侧上。在使用任何技术中，施加到纱布基底的浆料量被限制，以避免或至少最小化基底的饱和。优选地，胶质形式的高岭土(或其他粘土)用于提供稳定的材料悬浮液，该悬浮液具有使用狭缝式涂布技术来施加的合适粘性。
一旦使用狭缝式涂布技术喷射或施加，则涂覆的纱布基底被滚压或刮擦以进一步将高岭土嵌入到基底材料内。然后纱布基底被干燥。
在一些实施例中，高岭土可以使用粘结剂接附到纱布基底。在使用粘结剂的实施例中，粘结剂的材料是生物相容性的。优选的粘结剂包括壳聚糖以及聚乙烯醇，二者都具有粘合性，与生物组织相容且也表现止血特性。
用于生产此装置的一种典型方法可以包括下列步骤：将棉纱布从辊展开，将纱布浸入止血材料和水的浆料内，通过在高压下滚压湿纱布而将压力施加到纱布以将止血材料合并到纱布的材料内，将滚压的湿纱布干燥，和从纱布移除灰尘(例如，经由以气刀或空气喷嘴吹风，通过使用静电能，抽真空或以直接接触的刷子刷拭)。在从纱布去除灰尘后，纱布背部可以缠绕回到辊上，或纱布可以被切割为片用于单独包装。
可以操纵一个或多个变量来优化保持在纱布上的高岭土的量和完整性。这些变量包括但不限制于浆料温度、浸入时间、浆料搅动方法和(浆料的)液体类型。如上所指示，浆料温度的升高有助于将高岭土保持在纱布上。搅动可以通过促使空气或其他气体通过喷嘴、搅拌、起泡、沸腾或超声振动实现。
用于浆料的液体也可以不同于水。例如，液体可以是氨水溶液。氨水已被发现导致某些纤维材料，例如典型地用于制造纱布的材料的膨胀。
现在参考图4，本发明的止血装置的另一个实施例是总地以20示出的具有止血特性的布，且在下文中称为“布30”。布30是可以由织造或非织造束或毡或类似物限定的织物，生物止血材料灌注或灌输到所述织物内。可以灌注或灌输到布30的织物内的止血材料包括但不限制于微粒32形式的粘土(例如高岭土)、其他基于二氧化硅的材料(例如硅藻土、其组合或类似物)、壳聚糖、前述材料的组合等。在这样的材料灌注或灌输到布的实施例中，材料优选地以水合状态合并到布内且随后被干燥。
在纱布或布的实施例中，纱布或布材料可以与多醣或类似材料交联。
现在参考图5，本发明的另一个实施例是绷带，示出为50，所述绷带包括保持在网12内且安置到能够(例如，使用压敏粘合剂将绷带50附着到佩戴者皮肤)施加到创伤的柔性基底52的微粒化高岭土14(或一些其他粘土材料或硅藻土)。网12被缝合、胶粘或另外地安装到基底52以形成绷带50。
基底52是塑料或布构件，它有益于在出血创伤上或靠近出血创伤保持在伤员或受伤动物的皮肤上。粘合剂54布置在基底52的接合伤员或受伤动物的皮肤的表面上。特别地，如果基底52是不可通气的塑料材料，则基底可以包括孔56以允许从皮肤表面蒸发的湿气消散。
现在参考图6，本发明的另一个实施例是海绵，示出为60，所述海绵包括基底62、布置在基底62的一个面上的微粒化高岭土14(或一些其他粘土材料或硅藻土)和布置在基底的相对面上的释放剂64。海绵60允许微粒化高岭土14与从创伤流出且通过释放剂64和基底62的血液的充分接触，同时最小化海绵到创伤组织的附着。海绵60也与活组织可相容。
基底62是限定基体的吸收性纱布材料。然而，本发明不如此限制，因为例如人造纤维/聚酯纤维素共混物等的其他材料也在本发明的范围内。可制造基底62的其他材料包括织造织物、非织造织物、纸(例如，牛皮纸等)和纤维素材料(例如，球、药签等形式的棉)。制造基底62的任意材料可以具有弹性。当弹性材料用作基底62时，海绵60变成止血装置和压力绷带，特别是在添加表面粘结剂或机械紧固件以将海绵在创伤上固定到位的实施例中。
在海绵60内使用的止血剂不限制于微粒化高岭土14。也可以使用例如绿坡缕石、斑脱土、前述材料的组合或前述材料与高岭土的组合的其他材料。本发明也不限制于粘土，因为例如生物活性玻璃、生物止血剂、硅藻土、前述材料的组合、前述材料与粘土的组合的其他材料也在本发明的范围内。
微粒化高岭土14可以通过库仑力，通过灌输或另外地将粘土或其他止血材料直接合并到基底材料内，通过使用粘结剂，通过将止血材料收集在基体内等结合到基底62。
当使用粘结剂将微粒化高岭土14结合到基底62时，粘结剂材料可以为海绵60提供另外的功能性。可以制造粘结剂的材料包括但不限制于壳聚糖、聚乙烯醇、瓜耳胶、胶凝淀粉、多醣、纤维素(例如，羧甲基纤维素)、藻酸钙等，以及前述材料的组合。
在微粒化高岭土14直接合并到基底62的实施例中，微粒化高岭土可以在基底制造期间添加。如果基底是含有人造纤维和聚酯的非织造纱布材料，则微粒化高岭土14可以合并到人造纤维和聚酯的纤维内或上。例如，微粒化高岭土14可以是粉末形式且施加到熔融的聚酯，且聚酯纤维可以从聚酯/止血材料熔融物中抽出。如果基底是织造纱布(例如，棉)，则粉末形式的高岭土14可以在线形成期间合并到棉线内。
释放剂64是布置在基底62的接触创伤侧上的材料，以便于在形成血液凝块后将海绵60容易地从创伤组织移除。释放剂64可以是连续膜或可以在基底的表面上不连续。可以用作释放剂的一种材料是聚乙烯醇，其是生物相容性材料，可以形成为薄膜且不显著地影响海绵60的吸收性和液体渗透性。释放剂64可以直接施加到基底62的创伤接触表面。
替代地，释放剂64可以作为粘土和释放剂浆料施加到基底62的非创伤接触表面。在这样的实施例中，聚乙烯醇的浓度使得乙醇的至少一些渗漏到基底62的创伤接触表面，而粘土材料保留在非创伤接触表面上或附近。在任何实施例中，聚乙烯醇不仅用作释放剂而且用作抑制微粒化高岭土14的灰尘的制剂。
在本发明的范围内可以用作释放剂的其他材料包括但不限制于硅树脂和胶凝淀粉。如同聚乙烯醇，任一材料可以以膜形式施加。
海绵60可以进一步包括赋予海绵不透辐射特征的成分。在这样的实施例中，硫酸钡可以合并到包括微粒化高岭土14的浆料内且施加到基底62。
海绵60可以进一步包括水或乙醇，因此允许海绵用作擦拭物。
现在参考图7，海绵的另一个实施例总地以160示出。海绵160包括膜162，微粒化高岭土14散布到该膜162内。海绵160的物理完整性通过膜162维持。优选地，制造膜162的材料是聚乙烯醇。在制造海绵160中，微粒化高岭土14散布到聚乙烯醇内，该聚乙烯醇然后形成为片。海绵160在合并到绷带内时尤其有用。
现在参考图8，海绵的另一个实施例总地以260示出。海绵260包括基底262、布置在基底上的微粒化高岭土14和布置在止血材料上方的膜266。微粒化高岭土14是未结合的(无粘结剂)凝血剂且优选地以条布置在基底262上以便于海绵260的折叠。膜266是聚乙烯醇或类似物且应用于包含微粒化高岭土14和最小化灰尘生成。当应用于出血创伤时，来自创伤的血液被芯吸入基底262内且接触微粒化高岭土14。
现在参考图9，海绵的另一个实施例总地以360示出。海绵360包括夹在两个基底362之间的微粒化高岭土14。基底362可以以任何合适的方式结合在一起，例如通过选择地无微粒化高岭土14的区域的热密封，在选择的区域内使用粘合剂或粘结剂，将材料(例如聚乙烯醇)的保持膜施加在整个海绵360的上方，或前述方式的任何方式的组合。
海绵60(以及示出为160、260和360的海绵)可以折叠且以多种方式使用。海绵60可以折叠使得其上布置有微粒化高岭土14的表面处于折叠的海绵的内侧表面上，以最小化灰尘问题以及止血材料从基底62分离的问题。海绵60(和海绵160、260和360)也能够折叠为褶状形式或折叠为产生多个沿边缘接附的不同层的构造。通过将海绵60以这样的方式构造，能够解决不同应用的顺应性和吸收性要求。海绵60也能够切割或形成为延长的条用于缠绕在伤员或受伤动物的创伤上，或用于合并到圆柱或药签内。海绵60也能够被切割、扯开、研磨或另外地形成为用于应用的小块，例如填充到网容器内。
例1-浆料温度对于棉纱布保持高岭土粘土能力的影响
改变高岭土/水浆料的温度以评估棉纱布保持高岭土粘土的能力。准备水和EPK的浆料，其中高岭土占浆料总重的40％。通过将棉纱布浸入到温度变化的浆料内、将湿海绵在压力下滚压和干燥，制成三个海绵(每块纱布一个)。下表指示了对于每个浆料的参数以及所获得的结果。
  样本   浆料温度(℃)  搅动方法   开始纱布重量(克)   随后纱布重量(克)   高岭土百分比(重量％)
  1   22  搅拌1分钟   3.139   5.59   44
  2   90  搅拌1分钟   3.064   5.868   48
  3   100  沸腾1分钟   3.085   6.481   52
随后纱布重量是纱布在滚压和干燥后的重量。注意到升高的浆料温度增加了保持的高岭土的量。对于这个的一种理论是纱布的棉纤维结构通过其浸入到热液体内而松弛且膨胀。
例2-应用干燥的高岭土到干燥的棉纱布以形成止血装置。将干燥的高岭土施加到干燥的棉纱布上。然后将纱布滚压。保持在纱布上的高岭土的量显然地且明显地小于保持在样本3(例1)的纱布上的高岭土的量。然而，与未加速的血液凝结时间相比，此样本将绵羊全血的凝结时间加速70％。
虽然已关于本发明的详细实施例示出且描述了本发明，但本领域普通技术人员将认识到的是可以进行多种改变且等价物可以替代本发明的元件而不偏离本发明的范围。另外，可以进行修改以使特定情况或材料适合于本发明的教导而不偏离本发明的基本范围。因此，本发明意图于不限制于在以上详细描述中公开的特定实施例，而是本发明将包括落入附带的权利要求的范围内的所有实施例。

Claims (15)

1.一种能够在出血创伤上提供止血作用的装置，所述装置包括：
柔性纱布基底；
布置在所述纱布基底上的粘土材料；
粘结剂，其为生物相容性的，所述粘结剂将所述粘土材料附着到所述纱布的表面；其中所述粘土材料和所述粘结剂被沉积在所述纱布上；其中所述装置被干燥；以及
其中当处理出血伤口时，所述装置的应用导致所述粘土材料的至少部分与血液接触。
2.根据权利要求1所述的装置，其中所述粘土材料是高岭土。
3.根据权利要求1所述的装置，其中所述粘土材料从包括绿坡缕石、斑脱土、高岭土以及前述材料的组合的组中选择。
4.根据权利要求1所述的装置，进一步包括布置在所述纱布基底上的硅藻土。
5.根据权利要求1所述的装置，其中所述粘土材料进一步包括从包含硫酸镁、偏磷酸钠、氯化钙、糊精、前述材料的水合物和前述材料的组合的组中选择的材料。
6.根据权利要求1所述的装置，其中所述粘土材料进一步包括从包含抗生素、抗菌剂、消炎剂、止痛剂、抗组胺剂、含有银或铜离子的化合物和前述组分的组合的组中选择的药物活性组分。
7.根据权利要求6所述的装置，其中所述抗菌剂为抗真菌剂。
8.根据权利要求1所述的装置，其中所述纱布基底由从包含棉、丝、毛、塑料、纤维素、人造纤维、聚酯和前述材料的组合的组中选择的材料制造。
9.根据权利要求1所述的装置，其中所述粘结剂选自下述材料：聚乙烯醇、多醣、以及前述材料的组合。
10.根据权利要求1所述的装置，其中所述粘结剂选自下述材料：壳聚糖、聚乙烯醇、瓜耳胶、胶凝淀粉、纤维素、藻酸钙、以及前述材料的组合。
11.根据权利要求1所述的装置，其中所述纱布合并到绷带内。
12.根据权利要求11所述的装置，其中所述绷带包括所述基底上的粘合剂。
13.根据权利要求1所述的装置，其中所述基底是弹性材料的并且所述装置进一步包括释放剂。
14.根据权利要求13所述的装置，其中所述释放剂从包括聚乙烯醇、硅树脂和胶凝淀粉的组中选择。
15.根据权利要求1所述的装置，其中所述基底是弹性材料的并且所述装置进一步包括提供不透辐射的成分。
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