CN102107024B - 递送粉末至伤口的装置 - Google Patents

递送粉末至伤口的装置 Download PDF

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CN102107024B
CN102107024B CN2011100019964A CN201110001996A CN102107024B CN 102107024 B CN102107024 B CN 102107024B CN 2011100019964 A CN2011100019964 A CN 2011100019964A CN 201110001996 A CN201110001996 A CN 201110001996A CN 102107024 B CN102107024 B CN 102107024B
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J·J·卡波里克
M·J·考特
K·E·格林纳沃特
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Abstract

将含有生物可吸收透明质酸(“HA”)的干粉直接应用至患者伤口中的所需部位来减少粘连，而不需要首先形成水合凝胶。HA包括已经修饰的、交联的或与其他物质组合的透明质酸。重要的是控制粉末中的颗粒大小。粉末是基本上干的和可吹动的粉末。至少90％的粉末颗粒具有30μm至1mm的最大尺寸。

Description

递送粉末至伤口的装置
技术领域
本发明涉及防止粘连，特别是在手术伤口愈合过程中形成的粘连。 
背景 
不希望的组织疤痕形成有时可连接相邻的身体组织层或组织和内部器官，而其本不应该是连接的。这样的内部疤痕形成称为粘连，可在外科手术操作后的愈合过程中形成，阻止了那些组织和器官相对于它们邻近结构的正常运动。 
已经提出了多种防止粘连的组合物，如高分子量含羧基生物聚合物的水合凝胶，形成物理屏障以在愈合过程中将组织彼此分隔开来，使得邻近结构间不形成粘连。理想地，该屏障是生物可吸收的，使得在其不再需要后逐渐消除。 
概述 
我们已经发现含有透明质酸(“HA”)的干粉可以直接应用于患者伤口中的所需部位来减少粘连。应用这种粉末时，在体液和液体的存在下，干粉将水合形成凝胶，其作为粘连屏障。HA包括已经修饰的、交联的或与其他物质组合的透明质酸。重要的是控制粉末中的颗粒大小。 
总的来说，本发明一方面为含有生物可吸收HA的基本上干的可吹动的粉末。“干”意思是具有足够低的含水量以容许流动气流中颗粒的有效夹带，例如低于25％重量的水。“可吹动”意思是具有容许流动气体中夹带颗粒有效而可控方向的大小、含湿量和形状。至少90％的粉末颗粒具有5μm至1mm的最大尺寸。本发明这方面的优选实施方案中，粉末进一步包含羧甲基纤维素(CMC)，且可以将HA或CMC或两者修饰来降低所述粉末的溶解性或提高其抗粘连性或两者。修饰可以使得粉末包含HA或CMC或两者与碳二亚胺或二乙烯砜(divinylsulfone)的反应产物。优选，至少90％的粉末颗粒具有70μm至600μm的最大尺寸，特别是有待通过喷雾来应用粉末时。 
本发明的另一方面中，将含有生物可吸收HA、CMC或两者的粉末应用至期望减少粘连的伤口中的部位，其浓度足以减少伤口愈合时的粘连。优选，至少90％的粉末颗粒具有5μm至1mm的最大尺寸。 
本发明这方面的优选实施方案中，以高于2mg/cm2的质量/面积来应用粉末。通常，伤口是外科手术伤口。例如，可以通过开放的切口将粉末直接应用至其中粘连可成为问题的外科手术区内的部位。可通过喷雾器来应用，或由具有粉末存储器和大小为当抖动抖落器(shaker)时释放粉末的孔口的抖落器施用。本发明还可用于防止通过对患者行腹腔镜检查操作而产生的手术伤口愈合过程中的粘连。在那种情况中，通过导管(穿刺套管)将粉末应用至伤口，该导管连通患者体外的第一部位和患者体内的第二部位。本发明因此提供了一种改进的方式来通过腹腔镜检查装置用粘连屏障包被干网状组织假体。一旦网状物于伤口中就位，就通过出口导管将粉末应用至网状物的表面。 
更总体而言，上述方法可用于包被已经置于伤口中的组织假体(例如，网状物)。例如，通过在原位包被假体的边缘来控制可围绕假体边缘形成的粘连。还可以包被假体中的钉子或缝线来减少那些部位的粘连。或者，可以将假体置于没有任何屏障层的伤口中，然后覆盖粉末。优选，在应用粉末前用水溶液浸透假体。 
根据本发明的一方面，在通过含有粉末的腔室的气流中夹带粉末。将所得到的夹带粉末的气流导向应用部位。可通过手动气泵或挤压球或通过医院手术室中的压缩气体源来提供气流。可以通过所置的将粉末从存储器携带至伤口中应用部位的管状导管将夹带的粉末提供至应用部位。导管可包括气流调节器，如置于导管中的涡旋叶轮(swirlinducer)来赋予气流以径向分量。 
优选在应用粉末之前冲洗伤口部位来提供液体用于将粉末水合成凝胶。 
本发明另一方面为用于将粉末(如上述的粉末)递送至伤口的装置。该装置包括连接进气导管和出气导管的粉末存储器。导管连接存储器以在通过进气导管进入和通过出气导管排出的气流中夹带粉末。可通过连接到进气导管的手动气泵或挤压球来提供气流，且泵或挤压球可以置于手柄内使得使用者可以一手把握装置，当握住时挤压泵或球并从出气导管递送粉末。或者，进气导管包括连到医院手术室气体供应的连接器。出口导管可包括涡旋叶轮，将径向分量添加至气流速度。该装置还可以包括置于存储器上游的阀门，来防止从存储器回流。存储器可以是可拆卸的，使得使用后可以用含有新粉末装料的存储器来替换用过的存储器。优选至少出口导管是疏水的以防止液体蓄积，例如，其用疏水材料包被或由疏水材料如疏水塑料制成。 
一实施方案中，粉末是HA或CMC，或两者。 
本发明再一方面为制造上述粉末的方法，通过提供含有HA的固体物质，磨碎含有HA的固体物质，并筛分含有HA的固体物质来选择特征在于至少90％的粉末颗粒具有5μm至1mm最大尺寸的材料。 
附图和以下的描述中列出了本发明的一个或多个实施方案的详细内容。本发明的其他特征、目的和优势将由说明书和附图以及权利要求显而易见。 
附图说明
图1是递送抗粘连粉末的手持式手枪握把喷雾器的一实施方案的侧视图。 
图2是递送抗粘连粉末的喷雾器的第二个实施方案的侧视图，其中使用带有喷雾阀门的加压罐。 
图3是图解视图，部分为截面，显示了粉末颗粒的夹带。 
图4是手持式手枪握把喷雾器的另一个实施方案的视图。 
图5是球形喷雾器的另一个实施方案的视图。 
图6是使用压缩气体源的喷雾器的图解视图，部分为截面。 
图7是球形喷雾器另一个实施方案的图解视图，部分为截面。 
图8是制造粉末方法的流程图。 
各附图中同样的参照符号表示同样的元件。 
详述 
粉末制剂
本发明的特征在于含有透明质酸(“HA”)的粉末，及其制造和用途。我们首先描述材料本身，然后我们描述粉末的形成。 
HA是天然存在的粘多糖，例如，发现于滑液，玻璃体液，血管壁和脐带以及其他结缔组织中。该多糖由交替的β-1-3葡糖苷酸键和β-1-4氨基葡糖苷键连接的交替的N-乙酰-D-葡糖胺和D-葡糖醛酸残基组成，使得重复单元是-(1→4)-β-D-GlcA-(1→3)-β-D-GlcNAc-。在水中，未修饰的透明质酸溶解形成高度粘性的液体。从天然来源分离的透明质酸的分子量通常落在5×104直至1×107道尔顿的范围内。 
我们使用术语HA来包括如上所述的透明质酸及其任意的透明质酸盐，包括例如透明质酸钠(钠盐)，透明质酸钾，透明质酸镁和透明质酸钙。我们还意在包括经化学修饰(“衍生”)形式的HA。特别地，我们优选Genzyme’s 
Figure BDA0000042613080000041
和 
Figure BDA0000042613080000042
产品中所用的HA/CMC材料。合适材料的概括公开内容可以在US 6,235,726，US6,030,958和5,760,200中找到，其中每篇在此引入作为参考。“HA”意思是含有透明质酸的物质，包括已经修饰的、交联的或与其他物质组合的透明质酸。 
关于衍生化HA的更多背景，Danishefsky等，1971，CarbohydrateRes.，Vol.16，p199-205，描述了通过将粘多糖的羧基转化成取代的酰胺来修饰粘多糖，这是通过在水溶液中在1-乙基-3-(3-二甲基氨基丙基)碳二亚胺氢氯化物(“EDC”)的存在下将粘多糖与氨基酸酯反应。他们将甘氨酸甲酯与多种多糖包括HA反应。所得到的产物是水溶性的；即，它们快速分散于水中或含水环境中，如身体组织之间遇到 的含水环境。 
使HA组合物水溶性较低的提议包括将HA交联。R.V.Sparer等，1983，第6章，p107-119(T.J.Roseman等，Controlled ReleaseDelivery Systems，Marcel Dekker，Inc.，New York)描述了通过酰胺键将半胱氨酸残基连接至HA来修饰HA，然后通过连接的半胱氨酸残基之间形成二硫键来使半胱氨酸修饰的HA交联。半胱氨酸修饰的HA本身是水溶性的，只有在通过氧化交联成二硫化物形式时才变成水不溶性的。 
De Belder等，PCT公开号No.WO 86/00912，描述了可缓慢降解的凝胶，用于防止外科手术后的组织粘连，其通过将含羧基多糖与双-或多官能环氧化物交联来制备。已经提出用于制备具有降低水溶解度的交联HA凝胶的其他反应性双-或多官能试剂包括：50℃碱性介质中的1，2，3，4-双环氧丁烷(T.C.Laurent等，1964，Acta Chem.Scand.，vol.18，p274)；碱性介质中的二乙烯砜(E.A.Balasz等，U.S.专利No.4,582,865(1986)；和多种其他的试剂，包括甲醛，二羟甲基脲，二羟甲基亚乙基脲，环氧乙烷，聚氮丙啶，和聚异氰酸酯(E.A.Balasz等，U.K.专利申请No.8420560(1984))。T.Malson等，1986，PCT公开号No.WO 86/00079，描述了制备用作玻璃体液替代物的HA交联凝胶，通过将HA与双-或多官能交联试剂如双-或多官能环氧化物反应来制备。T.Malson等，1986，EPO 0193510，描述了通过真空干燥或压缩交联的HA凝胶来制备成型的物品。 
上述参考文献总地公开了怎样获得适于水合产生凝胶的颗粒形式的材料。通常，为了生产适于根据本发明应用的粉末，将从化学加工获得的原料如上述各参考文献中所述进行沉淀，干燥，并使用标准研磨技术研磨来消除结块并减小颗粒大小。 
通过筛分经研磨过的颗粒来实现对颗粒大小的控制。将粉末放置于具有不同大小筛孔的一系列筛子中。然后用手或机器摇动筛子直至粉末截留在筛网上或允许通过。可收集不同范围的颗粒大小。通过称重所有筛过的部分或通过颗粒分选设备如激光衍射粒度分级器来测量 颗粒大小的分布。 
可以通过筛分或颗粒分选设备如激光衍射粒度分级器来获得粉末颗粒最大尺寸的分布。 
我们一般优选颗粒大小的范围为70μm至600μm，尽管我们已经测试了该范围外的颗粒，它们可以在一些情况中有效，特别是从抖落器或相对短的喷雾管直接应用至开放手术区时。如果颗粒太小，例如小于60μm，则它们具有形成“云状物”的趋势，而不是在可有效喷雾的可控气流中夹带。云状物扩散而不是流动，难以控制它在伤口例如腹部中的位置。另一方面，如果颗粒太大，它们将不能在气流中有效夹带。我们优选保持最大的颗粒尺寸小于1mm，且对于喷雾优选小于600μm。理想地，大部分颗粒为约35μm至425μm的大小。可以用作参考的一种具体的颗粒大小分布是：少于约15％的颗粒为＞425μm；约30％具有小于约425μm的颗粒大小；和约10％具有小于38μm的颗粒大小。对于涉及将颗粒通过相对窄的导管喷雾的应用，例如，在腹腔镜检查应用中，阻塞可能是个问题。如果导管含有气流控制结构如涡旋叶轮，这尤其如此。对于这些应用，可以施加更严格的制造控制。避免太大而使得它们形成不容易在伤口部位上形成均匀涂层的粒子(例如，超过1mm的尺寸)的颗粒也是理想的。 
例如，不作为限制，图8的程序可以用于生产、包装并灭菌粉末。将HA-CMC粉末过筛来保留大小为425微米至约100微米的筛子之间的粉末。例如，在机械摇床上混合筛过的200g等份试样直至获得458g总的筛过的HA-CMC。使用机械摇动装置来摇动粉末。收集所需颗粒大小范围的粉末并混合在一起来提供在粉末的物理特性方面更均匀的粉末。可以在所示的筛分后直接进行该混合步骤或可以将该步骤移至就在填充操作前进行。一旦混合，将粉末分配至透湿袋(例如，聚乙烯)中，该袋子保留粉末但使粉末在随后的(DHT)步骤过程中释放水分。设计该脱湿热处理(DHT)步骤在100℃±5℃加热粉末最少6小时。DHT步骤后，将粉末在控制温度和湿度的区域中平衡。选择该平衡步骤的长度来提供对于水分的稳定状态条件，使得在填充操作过程中最 小(＜1％)的重量改变。例如，与环境湿度(例如，40％的相对湿度)的平衡持续32小时。将HA-CMC粉末分配至用于填充本文别处所述装置的小瓶中，例如，具有0.5，1.0和2.0克的额定填充量。加入额外的粉末来补偿粉末的含水量、填充容限和不能分配所有粉末的情况。然后将小瓶包装入提供防潮层和无菌层以及材料的容器中，随后将其包装来大批灭菌。将产品以25-40千戈瑞进行γ照射，并执行合适的质量控制。 
应用粉末的方法和装置
应用粉末的最直接的方法是从具有一定大小开口的抖落器释放粉末。当外科医生可获得相对开放的手术区时，该方法是合适的。其可以用于在这样的伤口中植入网状假体之前包被下面的内脏。 
或者，在朝向期望防止粘连的伤口位置的气流中夹带粉末。图1-7显示了可以用于该目的的多种喷雾装置。图1中，手握喷雾器10包括置于把手13中的挤压球12。挤压球具有进气阀14和连接至粉末存储器16的导管15。防止回流的阀门17，例如瓣阀，防止粉末吸入挤压球中。粉末20位于存储器16的底部。当挤压挤压球12时，空气通过导管15经阀门17流入存储器16中。空气流过粉末，将其夹带在经由导管22排出的气流中。存储器16内导管22的开端位于存储器的顶端，远离粉末和导管15的末端。置于导管22中的螺旋扩散器24将径向分量赋予气流，使得气流和夹带的粉末离开导管22时在伤口部位散开。 
图2-7中显示了备选的递送方法。图2显示了标准气溶胶罐30，包括压缩气体源(例如，CO2罐)和含有要在来自罐的气流中夹带的粉末的内部存储器(未显示)。通过启动阀门31来释放压力，其通过出口导管29释放压缩气流中夹带的粉末。 
图3显示了备选的粉末存储器构造，其中通过导管32提供进气流，该导管通过塞子/盖35中的孔进入存储器34的顶部并延伸至底部。带有夹带粉末的气流通过存储器顶部的第二个导管36出来。可以通过如图6中所示的压缩气体罐39或通过如图7中所示的挤压球41将气流 提供至这样的存储器中。 
图4显示了备选的挤压球49/手柄51装置40，其中存储器42的安置使得其可以插入和取下而不需要翻转该装置。进气导管44延伸至粉末中，而粉末在气流通过导管46排出时夹带在气流中。 
图5显示了整体挤压球60/粉末存储器62，其中通过挤压球将气流夹带的粉末压迫至递送导管。粉末存储器50可拆卸地插入挤压球52背部的凹处中。挤压球52迫使空气通过孔口54，且粉末夹带在通过连通递送导管58的导管56出来的气流中。 
有利地，外科医生只需要一只手来握住把手并挤压球。 
喷雾粉末的涂层应具有高于2mg/cm2的密度。优选涂层密度应为至少2.5mg/cm2，或甚至更高，例如，5mg/cm2。如果涂层太厚，其可能遮蔽手术区并导致其他并发症。如果涂层太薄，则可能不那么有效。 
已经描述了本发明的多个实施方案。尽管如此，应当理解的是可以进行多种改变而不偏离本发明的精神和范围。例如，Richard WolfGmbH，Postfach 1164 75434 Knittlingen Germany出售一种商用喷雾装置。因此，其它实施方案在以下权利要求的范围之内。 
申请人注意到在此所公开的喷雾装置的一些未要求保护的方面可能已由他人做出贡献，如上述发明名称为粉末递送装置的申请的发明人。 

Claims (16)

1.递送粉末至伤口的装置，所述装置包括连接进气导管和出气导管的粉末存储器，所述导管连接所述存储器以在通过所述进气导管进入并通过所述出气导管排出的气流中夹带粉末，所述存储器包含含有生物可吸收HA的且具有低于25%重量的水的可吹动的粉末，所述粉末的特征在于至少90%的粉末颗粒具有的最大尺寸不小于5μm且不大于1mm。
2.权利要求1的装置，其中所述进气导管连接挤压球。
3.权利要求2的装置，包括手柄，所述挤压球置于所述手柄内，从而允许使用者一手握住装置，当握住时挤压球并从出气导管递送粉末。
4.权利要求1的装置，其中所述进气导管包括连接至医院手术室气体供应的连接器。
5.权利要求1的装置，其中出气导管包括涡旋叶轮，将径向分量加至气流速度。
6.权利要求1的装置，其中所述存储器是可拆卸的，使得使用后能够用含有新粉末装料的存储器来替换用过的存储器。
7.权利要求1的装置，其中至少出气导管是疏水的。
8.权利要求7的装置，其中出气导管用疏水材料包被。
9.权利要求7的装置，其中出气导管由疏水材料制得。
10.权利要求8或权利要求9的装置，其中疏水材料是疏水塑料。
11.含有待引入期望减少粘连的伤口部位中的具有低于25%重量的水的可吹动粉末的装置，所述粉末的特征在于至少90%的粉末颗粒具有的最大尺寸不小于5μm且不大于1mm，所述粉末包含HA或CMC或两者，所述装置进一步包括存储器来盛装所述粉末和出口孔来将粉末应用至所述部位。
12.权利要求11的装置，其中所述粉末进一步包含CMC。
13.权利要求11的装置，其中修饰所述HA或CMC或两者以降低所述粉末的溶解性或提高其抗粘连性或两者。
14.权利要求11的装置，其中所述粉末包含HA或CMC或两者与碳二亚胺的反应产物。
15.权利要求11的装置，其中所述粉末包含HA与二乙烯砜或二环氧化物的反应产物。
16.权利要求11的装置，其中所述粉末的特征在于至少90%的粉末颗粒具有的最大尺寸不小于70μm且不大于600μm。
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EP1742692A4 (en) 2012-06-27
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US20100121261A1 (en) 2010-05-13
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