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CN101917947A - 真空辅助的伤口敷料 - Google Patents

真空辅助的伤口敷料 Download PDF

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CN101917947A
CN101917947A CN2008801173528A CN200880117352A CN101917947A CN 101917947 A CN101917947 A CN 101917947A CN 2008801173528 A CN2008801173528 A CN 2008801173528A CN 200880117352 A CN200880117352 A CN 200880117352A CN 101917947 A CN101917947 A CN 101917947A
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B·格里纳
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Abstract

本发明描述了用于将局部负压治疗施加于伤口部位的装置，该装置包括：用于将伤口渗出流体保持在其中的伤口接触元件；在伤口接触元件和伤口部位上方提供基本上气密密封的伤口覆盖元件；将伤口腔体连接于真空源的真空连接管；以及连接于真空连接管的远端的真空源。

Description

真空辅助的伤口敷料
发明领域
本发明涉及局部负压(TNP)辅助的伤口敷料，特别是、但不限于用来治疗较小面积和/或较小体积的伤口。
本发明主题是用于处理小到中型尺寸伤口的装置，该装置利用真空源，但通过在伤口腔体中使用吸收性自内聚性(self-cohesive)材料以传统方式处理伤口渗出物。除了通过局部蒸发以外，没有流体从伤口腔体的位置输出。这样，能够以对使用者的最小不便产生极其便携的系统。
背景技术
TNP治疗最近获得了商业成功。WO9605873及其同族专利描述了便携的TNP治疗装置。所述装置在伤口部位的附近机械支撑组织，组织力学以及从这种部位渗出的速率要求诸如WO9605873或如专利GB2378392和WO2005/082435中所述的系统，这些系统具有抽吸伤口渗出流体的远程(remote)废物容器，以便处理在较短时间内产生的流体量，该时间短于其中敷料正常保持在应有位置的时间。然而，对于表面积在大约200cm2以下或内部体积在大约1000cm3以下的伤口来说，这些方案可能不是最适当的，因为来自这些伤口的渗出物体积和渗出速率可以通过更传统的伤口敷料来处理，需要每3-7天更换敷料。较小尺寸的这种伤口使其对于现有技术中公开的传统TNP治疗来说没有吸引力；这些装置典型地包括远程真空源、流体转运管腔和远距离流体收集容器、控制和电源，并且尺寸和重量超出了患者方便或独立携带的范围。
现有技术中所述的TNP装置的一般原理包括流体渗透性伤口腔体填充元件、用于覆盖伤口和在伤口周围提供适当的气密密封的敷料、经由流体收集罐将伤口部位和腔体填充元件连接于真空源的引流管。伤口填充元件的确切性质已经是本领域中许多发明的主题。该装置的作用模式是对伤口腔体施加负压，引起伤口腔体填料压缩和周围组织扩展到伤口腔体中。通过静止的多孔腔体填料，沿着引流管从周围组织将伤口渗出物吸引到远距离收集容器内。现有技术的重要特征是伤口腔体填料在负压下压缩时保持充分多孔的能力，以便允许流体从组织运输到引流管或吸引管。孔隙度能够在分子水平下促进(例如水凝胶)或者在显微水平下促进(例如亲水性泡孔泡沫(hydrocellularfoam))。为了促进流体流动，疏水填料被本领域技术人员认为特别合意，而吸收性填料由于其阻碍流体转运是特别不合意的。
与TNP治疗原理相反，传统伤口敷料的一般原理是将伤口渗出物局限在伤口腔体内或紧密靠近表面的伤口部位。为此，阻止流体自由流动，优选吸收该流体且使之局限的高吸收性材料是合意的。由ConvaTec Ltd制造的Aquacel(商标)是无纺织物敷料的一个例子，其吸收大量的流体且有效将其锁定在敷料中。由Smith & Nephew Ltd制造的Allevyn(商标)是吸收大量的流体，同时允许通过高水汽渗透性外层膜来快速蒸腾的泡沫敷料的一个例子。
总之，现有技术仅仅处理从伤口部位离开的真空辅助的流体转运。在现有技术中已经描述且例示了多种伤口腔体填充和接触元件，包括通常用于传统伤口护理敷料的材料。在这些情况下无一例外的是，腔体填充和伤口接触元件用作经由连接于真空源的吸收管将流体从伤口本身转运到远距离收集罐中的导管。
本发明的一个目的是克服或减小现有技术处理低表面积伤口，尤其表面积低于约200cm2或内部体积低于1000cm3的伤口的局限性，而不求助于专门使用传统吸收性敷料。本发明的又一个目的是克服或最小化真空装置的可携带性的问题。
根据本发明的第一个方面，提供了用于将局部负压治疗施加于伤口部位的装置，该装置包括：用于将伤口渗出流体保持在其中的伤口接触元件；在所述伤口接触元件和伤口部位上方提供基本上气密密封的伤口覆盖元件；将所述伤口接触元件连接于真空源的真空连接管；以及连接于所述真空连接管的远端的真空源。
伤口接触元件基本上在大气压至大气压以下200mmHg的压力下阻止液体越过自身转运。优选地，伤口接触元件材料在比大气压低高达250mmHg的压力下阻止液体越过自身转运。
本发明涉及包括用于处理伤口的敷料的装置。与目前的治疗和TNP领域中的现有技术相反，本发明提供了的系统在使伤口享有TNP的许多益处的同时，其不允许伤口流体离开伤口腔体的界限而输出。该装置依赖于伤口接触元件，其不允许流体在施加于伤口的负压范围下越过本身输出。
根据本发明的装置的一个特定优点是，将伤口流体限制在伤口的最近区域使得可以提供极其轻小和因而高度便携的真空源以及真空源与伤口部位敷料的便利而简单的连接和断开机构(means)，这克服了现有技术装置的可用性和便携性的重大局限。
在本说明书中，术语‘伤口接触元件’是指填充伤口腔体或覆盖伤口的装置/敷料的部分。伤口接触元件的性质不受限制，前提是其组成或结构能够基本上阻止渗出物在上述规定压力范围下从其自身流走。
例如，伤口接触元件可以包括液体触发的阀门，其在与液体变得接触时关闭。这种阀门可以位于靠近伤口覆盖元件处的真空管连接点。因此，当被液体接触时，该阀门关闭，没有液体被真空管所转运。该阀门可以是电动机械阀或者包括吸水性材料的智能阀，该吸水性材料在与液体接触时扩张，从而封闭在压缩区域内。该吸水性材料可以放置在阀门的限制孔口内。位于这种阀门和伤口之间的伤口接触元件可以是吸收性的或非吸收性的，但优选是吸收性的。在本实施方案中，该填充可以是任何医学上适合的组合物，例如纱布、泡沫、织造织物、无纺织物、针织物或模塑材料。
或者，该伤口接触元件可以完全或部分包括适合的材料，该适合的材料被设计成使它能够吸收伤口渗出物，但不允许该流体传输到真空管。该构造通过两个参数来规定：构成伤口接触元件的材料的出口的孔口和该材料在润湿时的机械完整性。例如，载有渗出物的吸收性材料本身必须不沿着真空连接管移位(displace)。这是颗粒状或纤维状的、所谓的超吸收性材料的一个特殊的问题，因为即使当它们完全充满流体时，它们也能通过非常小尺寸的孔口通行，而在该尺寸以下时，则不能有效保持真空水平。实际上，这意味着，传输真空的管子越窄，真空压力随着离真空源的距离的损失越大，该负压损失对于宏观孔径来说可以忽略不计，但在孔径减小至低于1mm直径时则能够是重要的。为了克服这些问题，在我们的待审查专利申请GB0719065.5(与本申请具有共同所属权)中描述了与目前可获得的材料相比具有明显提高的自内聚性能的吸收性材料。
当在伤口接触元件中包含吸收性材料时，该吸收性材料未必作为流体转运阻止元件起作用，该材料可以优选能够吸收超过其自身重量5倍的流体，更优选超过其自身重量10倍的流体，还更优选超过其自身重量15倍的流体。这种高w/w流体吸收率可能是合意的，使得该伤口最初能够由低重量材料包扎，从而减小对伤口和患者的应力。
尤其适合于此目的的一组材料是所谓的超吸收性材料，例如以聚阳离子或聚阴离子聚合物为基础的材料。超吸收剂聚阴离子聚合物包括聚丙烯酸盐和多糖的多元酸衍生物，例如羧基烷基纤维素或结构性衍生物。优选地，当该材料是聚阴离子的时，它可以是聚丙烯酸盐或其衍生物或羧甲基纤维素或其衍生物。优选地，当该材料是聚阳离子的时，它可以是基于脱乙酰壳多糖的，更优选是羧基烷基脱乙酰壳多糖或其衍生物，还更优选羧甲基脱乙酰壳多糖。
一种特别优选的材料是在流体吸收时能够自聚结的超吸收性材料(参见我们的GB0719065.7，其内容通过引用并入到本申请中)。这些材料能够有效阻止流体越过其边界转运，并且在负压的影响下或者在由伤口腔体内的负压所导致的外部施加的物理应力的水平下不会本身流动或者解聚。
优选的材料属性可以是在伤口部位出血的情况下实现快速止血的能力。
另一优选的材料属性可以是杀死与其接触的病原如细菌或真菌的能力。优选地，该材料固有地是抗微生物的。
基于羧基烷基脱乙酰壳多糖的材料适宜地同时具有止血和抗微生物作用。
伤口接触元件材料能够以适合于使流体进入和吸收但不阻止流体从伤口接触元件流走的形式提供。适合的设计包括超吸收性颗粒分散在包括超吸收性材料的芯吸纤维(如在尿布中所使用的)或网状或不连续材料的网络中，例如开孔泡沫、针织物、层压件、织造织物或无纺织物材料。优选地，该材料可以是用于施加到大的二维伤口的无纺织物片的形式，或用于施加到大的三维伤口腔体的无纺织物球的形式。
伤口覆盖元件可以是对液体的流动来说基本上不渗透，但对于水蒸汽的传输来说可基本上可渗透或基本上不渗透的任何材料。伤口覆盖元件优选是高度顺应的透明材料，它可以任选被涂布，或者被制造成使得与伤口接触元件和患者皮肤接触的侧面可被视为粘合于皮肤。这里，粘合被认为是表示能够在没有负压的情况下保持在应有位置。用于制造高度顺应的透明伤口覆盖元件的适合材料包括聚氨酯、聚烯烃、聚丙烯酸酯、基于硅酮的聚合物或包括这些材料的任意组合的复合材料。
伤口覆盖元件可以是传统的伤口敷料，例如由吸收性泡沫组成，例如Smith & Nephew Medical Limited所制造的Allevyn(商标)或非吸收性薄膜，如由3M Inc制造的Tegaderm(商标)。
伤口覆盖元件可以任选设有将真空连接管与伤口覆盖元件连接的机构，例如通过伤口覆盖元件中的一个或多个中心孔口或径向孔口。该伤口接触元件可以通过本领域技术人员已知的任何方式经由伤口覆盖元件连接于真空连接管，包括鲁尔(luer)接头，例如市售的阀门和端口、磁耦合或粘合片或胶带。真空管与伤口覆盖元件的连接可以优选经由位于真空连接管的端部的非粘合弹性体杯和位于伤口覆盖元件本身中的压敏阀门来实现。当在其两个表面上存在规定大小的压差例如5-200mmHg时，压敏阀门可以打开。构成弹性体杯和压敏阀门的材料可以优选是基于硅酮的材料。合意的是，为了患者方便，该连接系统适合于反复连接和断开。
任选地，这些连接元件可以浸渍或涂有抗微生物材料，包括、但不限于抗生素、银化合物或材料、基于碘的配制剂、聚六亚甲基双胍、三氯生或氯己啶。优选地，这些元件可以涂有银簇(silver clusters)。
真空连接管可以具有任何适当的机械性能和用于将负压从真空源传输到伤口接触元件的孔径。然而，根据伤口接触元件的构型，管的孔径可以使得其不能输送伤口接触元件的干燥或水合组分。该管尽可能可顺应且重量轻，并且可以是螺纹的或线性的。该管可以是单个腔或多个腔，或者腔的组合，并且可以任选分开和/或再结合以形成独立的管状元件，用于处理单个伤口部位或多个伤口部位。所述管可以是不透明的或者是透明的。
伤口接触元件和伤口覆盖元件可以任选结合成单一元件。
伤口覆盖元件和真空连接管可以任选结合成单一元件。
伤口接触元件、伤口覆盖元件和真空连接管可以任选结合成单一元件。
真空源可以是任何可获得的真空源，并且可以任选通过例如压缩弹簧来机械驱动，且包括如现有技术中已知的注射器作为真空产生装置；或者例如电力驱动，例如真空泵。优选地，真空源能够产生相对于大气压的-10mm Hg到-250mmHg范围的真空。更优选地，真空源是能够产生相对于大气压的-10mmHg到-250mmHg范围的真空的真空泵。所述泵可以通过任何便利的方式来产生真空；隔膜泵、蠕动泵、文丘里效应泵和其他活塞泵均可适合于此目的。
真空源可以优选是重量低于500g，更优选重量低于100g，还更优选重量低于50g。
在真空源受电力驱动的情况下，电源可以是干线供电、电池电源或本地发电电源例如发条发电机(clockwork generator)、太阳能电池、热电池或人动电能(kinetic autorelay)型的电源。优选地，该电源可以是电池。
在电源为电池的情况下，该电池可以是一次性的或者可再充电的。当该电池为可再充电的时，再充电可以通过真空罩或电池本身的充电站来实现。电池寿命可以优选长于12小时，更优选长于24小时，还更优选长于72小时。该电池可优选重量低于100g，更优选重量低于50g。
电源和真空源可以单独或一起用外壳包装。优选一起用外壳包装。当有外壳时，电源和真空源的总重量可以优选小于1kg，更优选小于500g，还更优选小于200g。该外壳可以具有任何几何形状，但优选使其方便患者和/或护理人员处理和携带。它还可优选具有小于15×15×6cm的尺寸。
本发明的第一个方面的装置可以应用于伤口的处理。该装置的一般原理是，将伤口接触元件施加于伤口，用伤口覆盖元件覆盖所述伤口接触元件以及经由真空连接管将所述伤口接触元件连接于真空源。如上所述，这些元件的两个或更多个可以作为单一实体提供。优选地，对于大的二维伤口，伤口接触元件和伤口覆盖元件可以是单一实体。该结合的实体可以在其上表面含有压敏阀门，并且可以通过适当的手段附着到伤口的周围。敷料附着于患者可以在不存在粘结手段的情况下通过单独施加负压来实现，或者可以通过粘结手段来实现。附着可优选通过粘结手段来实现，例如施加于伤口覆盖元件的皮肤接触表面的压敏粘合剂。当粘结手段为压敏粘合剂时，它可以优选是聚(丙烯酸酯)或基于硅酮的配制剂。
根据本发明的第二个方面，提供了用于将局部负压治疗施加到伤口部位的装置，该装置包括：在伤口上方提供基本上气密密封的伤口覆盖元件；将伤口覆盖元件连接于真空源的真空连接管；连接于真空连接管的远端的真空源；该伤口覆盖元件具有与其联合的阀门机构，其仅允许流体从由伤口覆盖元件和伤口所界定的伤口腔体中流出。
当伤口接触元件和伤口覆盖元件处于就位时，真空源被启动，且优选连接于真空源的真空连接管可以经由伤口覆盖元件中的孔口或阀门连接于伤口覆盖元件。在施加负压治疗器件的任何时点，真空连接管与伤口覆盖元件的连接可以被可逆地中断，并且在患者或护理人员方便时重新建立。
在根据本发明的第一或第二方面的装置的一个实施方案中，敷料伤口覆盖元件可以包括如上所述的单向阀，该阀门基本上能够允许空气形式的流体经由真空连接管从由伤口覆盖元件界定的伤口腔体排出。如上所述，真空连接管可优选地与敷料/伤口覆盖元件重复连接和断开，而不对其造成损伤，使得真空源可以被患者移走，而敷料保持在应有位置但被密封，从而防止细菌进入和潜在感染，例如通过在伤口覆盖元件中存在单向阀实现。单向阀机构可以是简单的塑料材料自密封阀门，如用于TNP治疗领域以外的许多不同应用的市售阀门，如以“miniValve”的商标由Mini Valve International出售的那些阀门。
合意地，真空连接管可以通过非粘合手段连接于敷料/伤口覆盖元件，以便有利于其反复连接/端口，而不损坏伤口覆盖元件薄膜材料。在这方面，真空连接管可以通过“吸入器”机构在真空连接管的敷料端连接，该吸入器机构例如为杯形的、圆顶形的或钟形的可顺应的塑料材料元件，其与真空连接管流体连通并且该元件可以放置在伤口覆盖元件的阀门机构上和用周围的伤口覆盖元件材料密封，该吸入器机构经由真空源本身产生的真空保持在敷料/伤口覆盖元件上的应有位置。真空连接管的断开然后可以仅仅通过关闭真空源的电源或者通过经提升其边缘而打破吸入器的密封来进行(NB吸入器可以容易地通过该有意的操作来移除，但不能容易地由于大的垂直力(verticalextensive force)，例如在真空连接管上的拉引，而偶然移位。
当伤口接触元件充满有伤口渗出物时，可以断开真空连接管，伤口接触元件和伤口覆盖元件(或二者物理上的结合)可以更换为一组新的。
适合于通过本发明主题装置处理的伤口包括软组织和硬组织损伤，包括皮肤、肌肉、软骨、肌腱、骨头和内部器官。
在本发明的第二个方面中，高吸收性材料的伤口接触元件可以不存在，伤口渗出物可以通过真空源从伤口腔体中吸入到远程废物容器中。
为了更充分理解本发明，现在仅作为例示来参考附图描述实施例，其中：
图1所示为根据本发明的装置的一个实施方案和通过TNP治疗的伤口的示意性断面图；
图2A到2C示出了图1的简化配置和伤口接触元件充满的进程；以及
图3示出了液体接触触发的阀门。
现在参考附图，其中相同的特征用同样的附图标记来表示。
图1示出了伤口10的示意性断面图，伤口10上应用了根据本发明的装置12的一个实施方案，用于进行伤口的TNP治疗。伤口10具有放置在由伤口界定的腔体中的伤口接触元件14，该伤口接触元件与周围的健康皮肤16大致齐平。伤口覆盖元件18通过涂布于该伤口覆盖元件材料的皮肤接触表面上的压敏粘合剂层(未示出)的方式而施加于伤口上，从而与周围健康皮肤接触和密封。伤口覆盖元件18在伤口的一部分和伤口接触元件14以上的区域具有孔口20。单向阀22位于孔口20中，以便允许空气形式的流体从由伤口覆盖元件18和伤口本身10所界定的伤口腔体24所抽出。在本实施例中，电池驱动的真空泵形式的真空源26通过真空连接管28和杯形连接元件30连接于伤口腔体，所述杯形连接元件30在其中具有孔口32以便接受真空连接管28的端部。杯形元件30具有凸缘部分34，其坐落于伤口覆盖元件18材料的上表面36上，并与其密封。阀门22具有管口(orifice)40，其正常状态下由于其模塑材料例如硅酮塑料型材料的回弹性而关闭。管口40为裂口的形式，正常状态下被两个唇片42、44关闭(阀门管口的形状可以比喻为平叶片螺丝刀，且图1中的阀门管口40垂直于页面的平面)。阀门22最初通过凸缘部分46以及保持在孔口20中的圆形肩部48和凹进50而固定在伤口覆盖元件材料18中并与该材料密封，该凸缘部分46靠压在伤口覆盖元件18材料的下面。为了评价伤口腔体24，启动真空泵26，将杯形元件30放置在阀门22以上的伤口覆盖元件材料上，且伤口腔体24内的压力降低使得杯形元件30通过周围环境空气的过剩压力牢固密封到敷料上。当伤口腔体内的真空发展时，伤口覆盖元件18通过环境空气压力向下推压伤口接触元件14，而伤口接触元件14向伤口表面施压，从而对其进行TNP治疗。
虽然杯形元件30的凸缘部分34的下表面涂布粘合剂并以此保持在伤口覆盖元件材料上是完全可行的，但在本实施例中，真空连接管28与伤口敷料仅仅通过如上所述的环境空气压力来保持。在患者希望拆下真空泵26并放在一边时，这可以简单地通过关闭泵26、使泵降解(degrade)并且取下杯形连接元件30来实现。在该情况下，阀门22是自密封的，防止了细菌等进入伤口腔体24。
以上举例的阀门22是由Mini Valve International供应的miniValve(商标)。然而，该阀门仅仅是示例性的，且许多其他类型的适合阀门可以市购。例如，国际专利申请No PCT/EP2008/063046公开了在水合时聚结的组合物，其能够用于提供在与液体接触时关闭的阀门。该申请通过引用全文并入本申请，简要地公开了能够实现新型物理转化的适合组合物。所述物理转化包括在水合时第一稳定的物理几何结构转变为第二稳定的物理几何结构，其中水合能够使第一稳定的物理几何结构的空间上分离的元件或表面实现自聚结(融合)。
每一种几何结构均是物理稳定的。因此，第一稳定物理几何结构浸渍在过量溶液中导致转变为第二稳定的物理几何结构，而不会由于溶解导致材料质量的显著损失。即，第二稳定的几何结构是在过量溶液中不溶的，或者具有仅仅非常有限的溶解度。第二稳定的物理几何结构至少基本上是自支撑的，使得它能够在处于过量溶液中或从过量溶液中取出时保持其形状。在第二稳定的物理几何结构的典型优选形式中，本发明的材料是凝胶或凝胶状材料。该组合物的一个特征是在第一和第二物理几何结构中物体的物理均匀性。
该新型转化通过(至少部分地)由能够在干燥状态和水合状态下以物理稳定形式存在的材料构造物体来实现。此外，该材料的水合状态必须是充分自内聚的，即使当浸渍在过量溶剂中时，以便能够使融合发生。我们认为这是有限范围的物质状态所特有的性能，我们准备了其中的一些来举例说明本发明。
从广义上来说，当形成为适合几何结构的物体时，物质的组合物在适合的溶剂中水合时能够发生自聚结。
根据本发明的第一方面，提供了高分子量阳离子聚合物材料，其具有包括至少两个独立但相邻的表面的第一状态和其中聚合物由均一体组成的第二状态，其中该材料在水合时从第一状态转变为第二状态。
因此，在水合时，该材料膨胀，并且表面会聚或聚结，产生自支撑材料(通常是凝胶或凝胶状材料)体，其在任何维度上均具有均一的性能。在该材料体内不存在表面和其他界面。此外，该材料体是不可溶的，或者至少在水合溶剂中具有有限的溶解度，并且在引导(leading)(例如重力)下能够保持其物理性能。
术语‘适合的几何结构’被认为描述了一种配置，其中物体的分离(例如空间上分离、但未必物理上分离)元件或表面充分接近，以便能够在水合引发的膨胀时发生聚结。
术语‘适合的溶剂’被认为描述了一种流体(液体或气体)，其能够被物体所吸收，引起物体的膨胀和物理性能的改变(例如表面能量)。该适合的溶剂通常且优选是含水介质。
术语‘自聚结’被认为描述了两种或更多种空间上分离的、物理均一的元件转化为单一的物理均一的元件，或者同一元件的先前空间上分离的表面的融合。
能够形成物体的物质的适合组合物是完全或部分由高平均分子量的阳离子聚合物构成的组合物，所述阳离子聚合物包括具有阳离子电荷偏向的两性离子(同时携带阴离子和阳离子电荷)聚合物。该阳离子聚合物可以是合成或天然存在的聚合物，或者可以是合成或天然存在的聚合物的衍生物。优选地，该阳离子聚合物是携带胺官能团的聚合物。更优选地，该阳离子聚合物是多糖。还更优选地，该阳离子聚合物是脱乙酰壳多糖或脱乙酰壳多糖的衍生物。该脱乙酰壳多糖可以由任何来源获得，如海产品或真菌，并且优选具有超过10kDa(千道尔顿)，更优选超过100kDa和最优性超过200kDa的重均分子量(Mw)。
在聚合物为脱乙酰壳多糖的衍生物时，它优选是羧基化衍生物。更优选地，它是脱乙酰壳多糖的羧基烷基衍生物。还更优选地，它是脱乙酰壳多糖的羧甲基衍生物。脱乙酰壳多糖的羧甲基衍生物优选具有超过50kDa，更优选超过100kDa，尤其是超过500kDa，更尤其超过600kDa和特别是700kDa或更高的重均分子量。
羧甲基化优选使用已知试剂来实现：碱和氯乙酸，或者氯乙酸的中性盐如氯乙酸钠。优选地，该反应在单一步骤中进行：脱乙酰壳多糖纤维或(不太优选的)颗粒浸渍在试剂的溶液中，或反之亦然。适合的反应溶剂包括醇与水的混合物。该醇可以是任何已知的醇，但优选是脱乙酰壳多糖和羧甲基脱乙酰壳多糖的非溶剂，例如异丙醇。该碱可以是任何已知的碱，但优选是水溶性无机碱例如氢氧化钠或氢氧化钾，优选氢氧化钠。
根据组合物的第二个方面，提供了制备高分子量羧甲基脱乙酰壳多糖的方法，包括下列步骤：
a.将脱乙酰壳多糖与碱和氯乙酸或其中性盐的溶液混合，溶解在包括醇与水的混合物的反应溶剂中；
b.使该反应在环境温度下进行至少8小时，同时确保脱乙酰壳多糖充分暴露于反应溶剂；
c.当该反应结束时，在过量的含醇溶剂中洗涤反应产物；其中反应溶剂的体积(毫升)为脱乙酰壳多糖质量(克)的至少20倍。
高分子量羧甲基脱乙酰壳多糖优选包括具有至少500kDa，更尤其至少600kDa和特别是700kDa或更高的分子量的羧甲基脱乙酰壳多糖。
在一个优选实施方案中，反应溶剂(毫升)的体积超过脱乙酰壳多糖质量(克)达多于20倍但小于70倍，更优选多于30倍但小于40倍。
在另一个优选实施方案中，氯乙酸钠的质量超过脱乙酰壳多糖的质量不多于2倍，更优选不多于1.2倍。
在一个优选实施方案中，反应溶剂的醇是异丙醇。
在又一个优选实施方案中，该反应在环境温度下进行至少8小时，更优选至少15小时，还更优选至少18小时。
在一个特别优选的实施方案中，反应溶剂的醇是异丙醇，氯乙酸钠的质量不超过脱乙酰壳多糖的2倍(更尤其不超过1.2倍)，且让该反应进行至少8小时。
当提供粉末或纤维形式的脱乙酰壳多糖用于反应时，该材料应该在整个反应持续期间充分暴露于浑浊的(turbid)反应溶剂。该过程能够通过技术人员已知的任何方式来促进，但能够简单地通过例如转动反应容器来实现。
当该反应结束时，对产品稳定性有害的反应副产物例如氯化钠或羟基乙酸钠应该尽可能最大程度除去。为此，将反应产物洗涤，优选在一个或多个步骤中，在包括至少60份醇(例如乙醇)和40份水(60∶40)的过量溶剂中。
多于以上的洗涤步骤是优选的，且在该情况下，第一洗涤步骤优选比后续步骤具有更高水含量，且水含量在每一洗涤步骤中逐渐降低。例如，适合的两步洗涤工序包括在包括至少60份乙醇和40份水(60∶40)的过量溶剂中的第一次洗涤和在包括至少90份乙醇和10份水(90∶10)的过量溶剂中的第二次洗涤。
因此，在一个优选实施方案中，该反应产物在多个洗涤阶段中洗涤，每一次使用过量的包括醇和水的溶剂，其中在每一个后续的阶段中，该溶剂包括更高比例的醇。优选地，该醇是乙醇。
必要的是，洗涤溶剂总是包括一些水，以避免产物的过度脱水，这能够导致脆性。
洗涤溶剂的组合物可以包括任何适当的醇如乙醇、异丙醇或甲醇。乙醇是优选的。
由洗涤和溶剂去除所获得的产物可以通过通常用于医疗设备灭菌的方法如γ辐射、电子束照射或环氧乙烷处理来灭菌。
在基于辐射的灭菌之前，洗涤的反应产物应该充分地不含溶剂。这可以通过本领域技术人员已知的任何干燥方法来实现。优选的干燥方法是在不超过40℃，更优选不超过30℃的温度下进行。优选地，溶剂去除通过将该材料放置在低于大气压下来实现。该压力优选低于500毫巴，更优选低于1000毫巴。当通过真空干燥来进行时，干燥方法的持续时间优选超过8小时，更优选超过12小时。
在洗涤和辐射灭菌之后的材料的重均分子量优选高于120kDa，更优选高于130kDa，在洗涤和环氧乙烷灭菌之后优选高于400kDa，更优选高于500kDa。重要的是，获得这些分子量以避免最终产物的机械完整性问题和暴露于流体时的溶解问题。
可以在最终灭菌之前，在以上方法的任何阶段中加入添加剂和辅助组分(co-component)。这些试剂可以是适合于局部或内科应用的任何试剂，例如镇痛剂、麻醉剂、抗微生物剂、抗癌药、烟碱或烟碱替代物或其他合成或天然来源的药物，包括肽、蛋白如生长因子或生长阻滞剂、酶(例如有利于组织清创的那些酶)、DNA或RNA片段。
当添加剂是抗微生物剂时，该添加剂例如可以是：银或银化合物，碘或碘化合物，基于季铵的抗微生物剂如聚六亚甲基双胍或氯己啶，抗生素如庆大霉素、万古霉素或基于肽的试剂。
当将银引入到配制剂中并且该配制剂是基于羧甲基脱乙酰壳多糖的时，添加优选通过在溶剂混合物中浸渍来实现，该溶剂混合物具有与在羧甲基化过程中施加的溶剂混合物类似的组成。
在第三个方面，该组合物能够用于提供将两个或更多个固体表面融合的方法，其中所述表面是包括如本文所述的自聚结材料(尤其是本发明的第一个方面的高分子量聚合物材料)的一个或多个物体的最初分离(尤其空间上分离的)但相邻的表面。该方法包括将所述表面浸渍在含水介质中并且因此使自聚结材料水合和膨胀的步骤。在一个实施方案中，所述表面是同一物体的最初空间上分离的表面。或者，所述表面是不同物体的最初空间上分离的表面。这些备选方案不是相互排斥的。所述表面可以是纤维例如织造织物或更尤其无纺织物纤维材料的表面。在此类材料中，所述表面可以具有空间隔开的部分和虽然分开但接触的部分。
由以上定义的组合物制造的且适合于该方法的物体需要适当设计，以便能够在水合时发生聚结。例如，分离的线性物体将不具有在水合时自聚结的机会。相反，一对分离但相邻的线性物体将具有在水合时溶胀和聚结的机会。在本文中，‘相邻’是指彼此位于大约10mm内。因此，适合的物体可以被定义为含有彼此在大约10mm范围内的至少部分在空间上分开的元件或表面。优选地，空间上分开的元件或表面彼此位于5mm内。更优选地，空间上分离的元件或表面彼此位于1mm之内。在一些情况下，例如基于纤维的材料，相邻表面的至少一部分可以接触。
满足以上说明的优选物理型式(format)是基于纤维的材料，例如织造织物材料和无纺织物材料。其他适合的型式包括针织物、开孔泡沫和层压件，包括波纹材料。更复杂的配置可以通过本领域技术人员已知的方法来制造，例如平版印刷术、显微机械加工和电纺丝。该组合物及其用途不限于高开放区域的型式，而是包括固体整料。基于纤维的材料是优选的，且基于纤维的无纺织物材料是特别优选的。
能使用的所述组合物不限于仅仅由自聚结材料组成的物体，而是包括复合材料，例如普通医疗设备型式与自聚结材料和表面涂层的复合材料，例如基于可植入的金属或生物材料的设备，包括软组织替代物和关节植入物。适合于局部和内部伤口处理的复合材料包括将基于聚氨酯的材料如泡沫、板材和薄膜与自聚结材料(如粉末形式或更尤其纤维形式)的结合的那些复合材料。
当设备(至少部分地)包括浸渍在流体中的组合物时，它们吸收流体，溶胀，并跨越接触点发生自聚结。用途不限于特定组合物或特定流体，但在优选形式中和对于优选终用途，该流体最有选是基于水的。例如，在基于羧甲基脱乙酰壳多糖的材料的情况下，该流体优选是基于水的。基于水的流体的实例包括水或水的溶液，例如盐水或生物来源的流体如全血、血浆、血清、唾液、伤口渗出物或骨髓抽吸物。
所述自聚结材料的新型材料性能可以在许多应用中利用，例如在不可逆的流体阀门系统和模塑材料中。
实施例
实施例1
自聚结羧甲基脱乙酰壳多糖纤维的产生
A)合成
紧邻在反应之前，将氯乙酸钠(1.75g)溶解在4％氢氧化钠水溶液(7ml)中。将该溶液添加到异丙醇(45ml)中，强烈振荡，产生浑浊的悬浮液。将该混合物添加到含有脱乙酰壳多糖纤维(1.50g)的容器内，将该容器密封，在大约60rpm下转动18小时。
B)洗涤步骤
B1)在步骤A之后，从现已透明的反应溶剂中取出纤维，转移到含有99∶1乙醇∶水(200ml)的容器内。在1小时内将该材料每隔15分钟搅和，此时间后，将该材料取出，通过在吸收性材料的数层之间施加手工压力来进行物理干燥。在粗略干燥之后，将该材料在环境温度下真空干燥过夜。
B2)在步骤A之后，从现已透明的反应溶剂中取出纤维，转移到含有60∶40乙醇∶水(200ml)的容器内。在1小时内将该材料每隔15分钟搅和，此时间后，将该材料取出，转移到含有90∶10乙醇∶水(200ml)的第二容器内。在1小时内将该材料每隔15分钟搅和，此时间后，将该材料取出，通过在吸收性材料的数层之间施加手工压力来进行物理干燥。在粗略干燥之后，将该材料在环境温度下真空干燥过夜。
实施例2
自聚结羧甲基脱乙酰壳多糖纤维的产生(规模扩大)
紧邻在反应之前，将氯乙酸钠(96.8g)溶于4％氢氧化钠水溶液(387ml)中。将该溶液添加到异丙醇(2490ml)中，强烈振荡，获得浑浊的悬浮液。将该混合物添加到含有脱乙酰壳多糖纤维(83.0g)的容器内，将容器密封，在大约60rpm下转动18小时。在该时间之后，从现已透明的反应溶剂中取出该纤维，转移到含有99∶1乙醇∶水(2000ml)的容器中。在1小时内将该材料每隔15分钟搅和，此时间后，将该材料取出，通过在吸收性材料的数层之间施加手工压力来进行物理干燥。在粗略干燥之后，将该材料在环境温度下真空干燥过夜。
实施例3
自聚结羧甲基脱乙酰壳多糖纤维的辐射灭菌
将由实施例1、步骤B2获得的材料包装在可透气的灭菌小袋内，并通过30-40kGy的γ射线灭菌。材料灭菌前和灭菌后的分子量通过凝胶渗透色谱法来测定。灭菌之前的分子量是大约Mw 700kDa；灭菌后的分子量为大约Mw 140kDa。该材料分子量的如此变化尽管是明显的，但是使得材料的物理性没有被灭菌所显著改变。
实施例4
自聚结羧甲基脱乙酰壳多糖纤维的环氧乙烷灭菌
将由实施例1、步骤B2获得的材料包装在可透气的灭菌小袋内，并通过环氧乙烷处理来灭菌。材料灭菌前和灭菌后的分子量通过凝胶渗透色谱法来测定。灭菌前的分子量为大约Mw 700kDa；灭菌后的分子量为大约Mw 575kDa。该材料分子量的如此变化使得该材料的物理性没有被灭菌所显著改变。
实施例5
自聚结羧甲基脱乙酰壳多糖纤维的吸水性
将实施例3(100mg)获得的材料在水(4ml)中浸渍1分钟，并取出。将过量液体排出，然后将水合的透明物质称重。计算出该材料吸收了其本身质量约25倍的水，没有显著溶解。
实施例6
自聚结羧甲基脱乙酰壳多糖纤维的血清吸收率
将实施例3(100mg)获得的材料在血清(4ml)中浸渍1分钟，并取出。将过量液体排出，然后将水合的透明物质称重。计算出该材料吸收了其本身质量约13倍的血清，没有显著溶解。
实施例7
羧甲基脱乙酰壳多糖纤维在水中的自聚结
将实施例3获得的材料(100mg)在水(4ml)中浸渍1分钟，并取出。将过量液体排出，然后将水合的透明物质静置4小时。在该时间之后，该材料的个体纤维已经自聚结，此时该材料有效地是均匀而有弹性的水凝胶，能够在负载下稳定地保持其物理几何结构(图2)。
实施例8
羧甲基脱乙酰壳多糖纤维在血清中的自聚结
将实施例3获得的材料(100mg)在血清(4ml)中浸渍1分钟，并取出。将过量液体排出，然后将水合的透明物质静置4小时。在该时间之后，该材料的个体纤维已经自聚结，该材料有效地是均匀而有弹性的水凝胶，能够在负载下稳定地保持其物理几何结构。
图2A-2C显示了伤口渗出物吸收到伤口接触元件14中的阶段。基本的配置与图1相同，然而，图2已经被简化。图2A示出了新安置在伤口10中且没有任何渗出物被吸收的清洁敷料；图2B示出了部分充有渗出物的伤口接触元件14；以及图2C示出了充满伤口渗出物的伤口接触元件14。然而，伤口接触元件材料14的性质使得没有液体被真空连接管28抽吸到伤口腔体24之外或者甚至没有抽吸到伤口接触元件14本身之外。
图3示出了第一稳定的物理几何结构在水合时转化为第二稳定的物理几何结构的范例，其中水合能够使第一稳定的物理几何结构的空间分开的元件自聚结(融合)。在例A中，自聚结包括单一元件的空间上分开的表面的融合；在例B中，表面是两个独立元件的相邻表面。
下述实施例是以图1和/或图2和/或图3中所示的装置配置的用途为基础。
实施例1
将图1的装置应用于体外腔体伤口。用外科手术刀在猪腿关节上切割出5cm直径、5cm深度的腔体伤口。伤口腔体区域中的肌肉组织注射有盐水以确保组织在试验持续期间充分水合。在伤口腔体中填充羧甲基脱乙酰壳多糖纤维的无纺织物球的两个伤口接触元件，并且伤口腔体和填充物用Smith & Nephew Medical Ltd制造的、具有中心5mm直径孔口20的粘合剂硅凝胶片CicaCare(商标)覆盖。将连接于螺纹真空软管的鲁尔锁(loc)紧接头插入到该孔口中，并连接于由Virtual Industries Inc.制造的电池驱动的真空源Pac-Vac(商标)。观测到伤口边缘的立即收缩，无纺织物球被压缩到与皮肤的表面平齐。该系统未扰动地在应有位置保持8小时，此时间后，没有流体从腔体填塞物中流出，而是已经收集在填塞物中。
实施例2
具有由Smith & Nephew Medical Ltd制造的Allevyn Adhesive(商标)伤口覆盖元件14的基于图1的装置的组合件。在Allevyn Adhesive的外层膜中使用活检穿孔器产生3mm直径孔口。在该孔口上粘结由Mini Valve International B.V.制造的硅酮弹性体圆顶miniValve(商标)，零件编号DO 072.004。由Virtual Industries Inc.制造的微型真空源PAC-VAC V3200(商标)通过真空管28连接于手工制作的硅酮橡胶杯30。
实施例3
如实施例2中的基于Allevyn Adhesive的装置的用途。用外科手术刀在猪腿关节上切割出5cm直径、5cm深度的腔体伤口。伤口腔体区域中的肌肉组织注射有盐水以确保组织在试验持续期间充分水合。在伤口腔体中填塞包括羧甲基脱乙酰壳多糖纤维的两个无纺织物球的伤口接触元件14，并且伤口腔体24和填充物用实施例2中所述的改良Allevyn Adhesive敷料覆盖。打开如实施例2中所述的真空源，将真空管杯放置在位于Allevyn Adhesive中心的圆顶阀门上。观测到Allevyn Adhesive敷料和伤口边缘的立即收缩，无纺织物球被向下压缩到与皮肤的表面平齐。该系统未扰动地在应有位置保持8小时，此时间后，没有流体从腔体填塞物中流出，而是已经收集在填塞物中。
实施例4
实施例2中所述的基于Allevyn Adhesive的装置的用途。用外科手术刀在猪腿关节上切割出5cm直径、5mm深度的浅伤口。伤口区域中的肌肉组织注射有盐水以确保组织在试验持续期间充分水合。伤口用作为伤口接触元件14的羧甲基脱乙酰壳多糖的无纺织物片覆盖，且伤口和无纺织物片用如实施例2中所述的改良Allevyn Adhesive敷料作为伤口覆盖元件18覆盖。打开如实施例2中所述的真空源，将真空管杯放置在位于Allevyn Adhesive中心的圆顶阀门上。观测到Allevyn Adhesive敷料的立即收缩。该系统未扰动地在应有位置保持8小时，此时间后，没有流体从伤口敷料中流出，而是已经收集在伤口敷料中。
在通篇说明书和权利要求中，词语“包括”和“含有”以及这些词语的变体例如“包含”和“具有”是指“包括、但不限于”，而不意欲(也没有)排除其他部分、添加剂、组分、整数或步骤。
在通篇说明书和权利要求中，单数涵盖复数，除非文中另有规定。尤其，在使用不定冠词时，该表述被理解为包括复数以及单数，除非文中另有规定。
与本发明的特定方面、实施方案或实施例结合来描述的特征、整数、特性、化合物、化学结构部分或基团被理解为施用于本文所述的任何其他方面、实施方案或实施例，除非与之不相适应。

Claims (25)

1.用于将局部负压治疗施加于伤口部位的装置，该装置包括：用于将伤口渗出流体保持在其中的伤口接触元件；在该伤口接触元件和伤口部位上方提供基本上气密密封的伤口覆盖元件；将伤口腔体连接于真空源的真空连接管；以及连接于所述真空连接管的远端的真空源。
2.根据权利要求1所述的装置，其中所述伤口接触元件在大气压至低于大气压200mmHg的压力下阻止液体越过自身转运。
3.根据权利要求2所述的装置，其中所述伤口接触元件材料在大气压至低于大气压250mmHg阻止液体越过自身转运。
4.根据前述权利要求的任一项所述的装置，其中通过位于所述伤口接触元件和所述真空连接管之间的液体接触触发的阀门的关闭来阻止液体转运出所述伤口腔体。
5.根据前述权利要求1-3的任一项所述的装置，其中通过能够在施加的负压下吸收但不传输液体的伤口接触元件来阻止液体转运。
6.根据权利要求5所述的装置，其中所述伤口接触元件是自聚结的材料。
7.根据权利要求6所述的装置，其中所述自聚结材料选自：羧甲基脱乙酰壳多糖；以及羧甲基脱乙酰壳多糖的衍生物。
8.根据权利要求4所述的装置，其中所述液体接触触发的阀门由位于限制孔口中的吸收性材料构造。
9.根据权利要求8所述的装置，其中所述吸收性材料能够在施加的负压下吸收但不传输流体。
10.根据权利要求1-9的任一项所述的装置，其中所述真空连接管与所述伤口腔体的连接通过所述伤口覆盖元件中的孔口来实现。
11.根据权利要求10所述的装置，其中所述伤口覆盖元件中的孔口具有压敏阀门。
12.根据权利要求11所述的装置，其中在存在5-200mmHg的表面与表面间的压差时，所述压敏阀门打开。
13.根据权利要求1-12的任一项所述的装置，其中所述真空连接管与所述伤口覆盖元件的连接通过非粘合手段实现。
14.根据权利要求13所述的装置，其中连接通过表面与表面间的压差来实现。
15.根据权利要求1所述的装置，其中所述伤口接触元件和所述伤口覆盖元件被结合在单一物理实体中。
16.根据权利要求1所述的装置，其中所述伤口接触元件、伤口覆盖元件和真空连接管结合成单一物理实体。
17.用于将局部负压治疗施加于伤口部位的装置，其基本上如以上对于所附说明书和附图所述。
18.用于将局部负压治疗施加于伤口部位的装置，所述装置包括：在伤口部位上方提供基本上气密密封的伤口覆盖元件；将所述伤口覆盖元件连接于真空源的真空连接管；连接于所述真空连接管的远端的真空源；所述伤口覆盖元件具有与之联合的阀门机构，该阀门机构仅仅允许流体从由所述伤口覆盖元件和伤口界定的伤口腔体中流出。
19.根据权利要求18所述的装置，其中所述阀门机构是自关闭的单向阀。
20.根据权利要求18或19所述的装置，其中所述阀门机构是在所述伤口覆盖元件中形成的孔口中。
21.根据权利要求18-21的任一项所述的装置，其中所述阀门机构是压敏阀门。
22.根据权利要求21所述的装置，其中当存在5-200mmHg的表面与表面间的压差时，所述压敏阀门打开。
23.根据权利要求19-22的任一项所述的装置，其中所述真空连接管与所述伤口覆盖元件的连接通过非粘合手段实现。
24.根据权利要求23所述的装置，其中所述连接通过表面与表面间的压差来实现。
25.根据权利要求24所述的装置，其中所述真空连接管能够与所述伤口覆盖元件反复连接和断开，而不对其造成损伤。
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AU2008327659A1 (en) 2009-05-28
US20180361039A1 (en) 2018-12-20
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