CN102892393B - 用于止血应用的增强的吸收性多层织物 - Google Patents

用于止血应用的增强的吸收性多层织物 Download PDF

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CN102892393B
CN102892393B CN201180024450.9A CN201180024450A CN102892393B CN 102892393 B CN102892393 B CN 102892393B CN 201180024450 A CN201180024450 A CN 201180024450A CN 102892393 B CN102892393 B CN 102892393B
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staple fibers
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CN102892393A (zh
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O.莫罗耶-奥拉比西
D.S.谢蒂
R.W.范霍尔滕
D.钟
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Johnson and Johnson Medical SAS
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Ethicon SAS
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    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
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Abstract

本发明涉及包括多层非织造物的合成织物，所述多层非织造物由聚乙交酯/聚丙交酯共聚物的短纤维制成，其中每一层均具有不同的密度。所述多层织物可用作增强的吸收性止血医疗装置。

Description

用于止血应用的增强的吸收性多层织物
技术领域
本发明涉及可用作如下构造的增强的吸收性多层止血器，所述构造作为医疗装置使用。
背景技术
在外科中，控制出血对于改善手术效果以及缩短在手术室中外科的持续时间为至关重要且关键的。多种止血材料包括氧化纤维素基材料已作为敷料用于多种外科中，包括神经外科、腹部外科、心血管外科、胸外科、头颈外科、盆腔外科、以及皮肤和皮下组织手术。
结合医疗过程来使用多层织物是被普遍认可的。例如，将多层织物用作通用垫、伤口敷料、外科网(包括疝修复网、防粘连网和组织增强网)、缺损封堵装置和止血器。
Lichtenstein等人的美国专利No.5,593,441描述了如下复合材料假体，所述复合材料假体优选具有允许组织向内生长的一片聚丙烯网，例如网。此参考文献公开到，可利用适于组织增强和缺损封堵的其它外科材料，包括吸收性网例如羟基乳酸聚合物910网。Lichtenstein等人的复合材料假体还具有粘连屏障，优选为一片硅氧烷弹性体。
Schilder等人的美国专利No.5,686,090描述了使用结合非吸收性膜或吸收性膜的绒头织物以防止邻近组织的误生长并减少粘连。Schilder等人大致公开到，可将聚丙烯、聚酯、羟基乳酸聚合物、聚对二氧环己酮或聚卡普隆25用作抓绒材料或膜材料。
Dhanaraj等人的已公布的美国专利申请2006/00084930描述了增强的吸收性多层织物，其可在尤其适用于组织工程应用的医疗装置中使用。基本内容包括首先准备用于植入的修复部位，随后将增强的吸收性多层织物设置在所述部位处。第一吸收性非织造物包含含有脂族聚酯聚合物、它们的共聚物或共混物的纤维；而第二吸收性机织物或针织物包含氧化再生纤维素纤维。
Broadnax等人的美国专利No.4,626,253描述了如下装置，所述装置涉及用于控制出血的外科止血器，并且更具体地讲涉及具有优异处理特性和止血特性的氧化纤维素的针织物。
Shetty等人的美国专利No.7,666,803描述了制备可用作止血器的增强的吸收性多层织物的方法。基本内容包括首先准备用于植入的修复部位，随后将增强的吸收性多层织物设置在所述部位处。第一吸收性非织造物包含含有脂族聚酯聚合物、它们的共聚物或共混物的纤维；而第二吸收性机织物或针织物包含氧化再生纤维素纤维。该方法还描述了可用于制备上述特定发明中的基质的适当密度和厚度。
上述参考文献均没有描述出或提出其中各个层具有不同密度的增强的吸收性多层非织造物。此外，上述参考文献均没有描述出或提出具有止血功能的这种非织造双层织物。
发明内容
本发明涉及包含非织造基质的合成织物，所述非织造基质具有由聚乙交酯/聚丙交酯共聚物的第一吸收性短纤维和聚乙交酯/聚丙交酯共聚物的第二吸收性短纤维构成的至少两层，其中第一吸收性织物被压制成约60mg/cc的密度，并且第二吸收性织物被压制成约120mg/cc的密度。第一吸收性织物和第二吸收性织物可由在组合物中比例为90摩尔/10摩尔的乙交酯/丙交酯的共聚物组成。第一吸收性织物和第二吸收性织物可包含具有约0.75至2.5英寸长度的短纤维并/或可来源于约1至4旦尼尔/纤丝。织物短纤维可为卷曲的。第一吸收性织物和第二吸收性片材可被针刺到彼此中以固定非织造物基质。
在一个实施例中，第一吸收性织物被压制成约0.5mm至约1.5mm，更优选约1mm的厚度。作为另外一种选择，第二吸收性织物可被压制成约0.75mm至3mm，更优选约1mm的厚度。在一个实施例中，合成织物尤其是双层基质，可用作医疗装置，例如止血装置。
具体实施方式
本发明为可用作增强的吸收性多层(优选双层)止血装置的合成织物，所述合成织物具有至少两个非织造层，每层基本上由得自聚乙交酯和聚丙交酯纤维的共聚物的短纤维共混物组成，并且每层具有不同的密度。在一个实施例中，止血装置基本上不含任何氧化多糖材料。尽管氧化多糖材料(例如氧化再生纤维素)已知可用作止血器，但是ORC的存在可不利于生物活性止血剂的稳定性，可在伤口附近通过降低此区域内的pH而降低生物活性剂的活性水平，并且通常在放置到伤口上之后降解较快。
用于制备本发明基质的一种方法开始于将聚(乙交酯-丙交酯)共聚物熔纺成PGLA共聚物纤维。可将基于PGLA共聚物纤维的多长丝纱线固结、卷曲并且切割成具有2.0英寸长度的短纤维。短纤维随后可被梳理成网以产生非织造棉絮并且被压制成约1.0mm的厚度和约60mg/cc的密度。可通过下述基本上相同的工序来产生第二非织造棉絮：熔纺、固结、卷曲、切割、梳理成网、以及压制成约1.0mm的厚度和约120mg/cc的密度。将如上述制备的具有60mg/cc的第一密度和120mg/cc的第二密度的两种非织造物材料精确地叠放到彼此之上并且通过在针刺设备中穿行2遍而牢固地附接。将多层织物在3个分立的异丙醇浴中进行修整和擦洗以移除纺丝油剂和任何机械油。将擦洗过的多层织物在70℃的烘箱中干燥30分钟，冷却并称重。随后针刺的多层非织造物基质便适于用作止血装置。
制备本文所述的织物的一种方法是通过下述过程进行的。可将具有约1至4旦尼尔/纤维尺寸的吸收性聚合物纤维固结成约80至120旦尼尔的多长丝纱线，然后固结成约800至1200旦尼尔的纱线，热卷曲并且随后切割成具有约0.75至2.5英寸长度的短纤维。可将短纤维喂入多辊干铺粗梳机一次或多次并且梳理成均匀的非织造棉絮，同时在15-24℃的室温下将湿度控制在约20-60％之间。例如，可利用具有由交替辊和剥离辊覆盖的主圆筒的单圆筒辊盖板梳理机来制备均匀的非织造棉絮，其中将棉絮通过落纱辊从圆筒的表面脱落并且沉积在采集辊上。可通过针刺或任何其它合适的方式例如压延来进一步地处理棉絮。此后，可通过各种技术例如针刺将第一吸收性非织造物附接到第二吸收性机织物或针织物。随后可将增强的吸收性织物通过在适当的溶剂中洗涤来进行擦洗并且在温和状况下干燥10-30分钟。
使用适于溶解任何纺丝油剂的溶剂来擦洗织物。溶剂包括但不限于异丙醇、己烷、乙酸乙酯和二氯甲烷。然后在提供足够干燥且同时最小化回缩的状况下干燥织物。
本文所述的多层非织造止血基质在被施用到需要止血的伤口时提供和维持有效止血。如本文所用，有效止血为在止血领域的技术人员公认的有效时间内控制和/或减轻轻度至中度出血的能力。有效止血的其它表征可由政府管理标准等来提供。轻度至中度出血的实例包括但不限于因脾切除、肝切除、钝性肝损伤和钝性脾损伤导致的出血。
上文所述的多层非织造止血基质可包含一种或多种止血剂。对于本专利申请而言，止血剂为如下试剂，所述试剂具有止血作用，更优选的是，减慢、阻止并最终停止其应用部位处的出血。用于在损伤部位处产生止血作用的一种方法为引入存在于凝血级联过程中的一种或多种因子，所述因子可与自然存在于身体内的另一种或其它因子反应。在一个实施例中例如凝血酶可用于产生止血作用，而在另一个实施例中，凝血酶和纤维蛋白原相结合使用以产生期望的止血作用。还可提供附加的组分例如钙，以进一步增强凝血酶和/或纤维蛋白原的止血作用。
在一个实施例中，多层非织造止血基质将固体凝血酶和/或固体纤维蛋白原保持为粉末、颗粒形式而不存在间距且从其表面具有最小的粉末损耗，这部分地归因于添加止血剂的方式和基质的非织造特性。另外，由于不同的层密度，止血剂并非均匀地分散在整个基质中，使得较多的止血剂存在于相对低密度的非织造层中，所述相对低密度的非织造层被放置在损伤部位处。在用于将凝血酶和/或纤维蛋白原施用到基质的优选方法中，将包含一种或多种生物制剂的溶液分别冻干。然后利用超精细磨机、球磨机、或冷却的刀磨机将冻干的材料研磨成粉末。将粉末称重并且一起悬浮在其中不溶解蛋白质的载流体内。优选的载流体为全氟化烃，包括但不限于HFE-7000、HFE-7100、HFE-7300和PF-5060(可从3M公司(Minnesota)商购获得)。可使用其中不溶解蛋白质的任何其它载流体，例如醇类、酯类或其它有机流体。将悬浮液充分地混合并且通过常规方式例如湿法涂布、干法涂布、或静电喷涂、浸涂、涂抹、或喷洒而施用到吸收性非织造物，同时保持约15至24℃的室温以及约10至60％(优选不超过30％)的相对湿度。然后将多层非织造基质在环境室温下干燥并且包装在合适的防潮容器中。具有凝血酶和/或纤维蛋白原的止血敷料包含不超过25％的水分，优选不超过15％的水分，并且最优选不超过5％的水分。
凝血酶和/或纤维蛋白原可为动物源的、人体的、或可为重组的。敷料上的凝血酶活性可在约20至500IU/cm2，优选约20至200IU/cm2，并且最优选约50至200IU/cm2的范围内。敷料上的纤维蛋白原活性可在约2至15mg/cm2，优选约3至12mg/cm2，并且最优选约5至10mg/cm2的范围内。施用到非织造物的凝血酶和/或纤维蛋白原粉末的量优选为覆盖其表面的足够量，使得不存在可见的未覆盖区域。粉末可主要位于非织造物之上或者更优选地渗入非织造物中。
作为外科敷料，本文所述的止血基质可用作主伤口闭合装置例如动脉闭合装置、缝钉和缝线的辅助件，以密封气体、液体、或固体的潜在泄漏以及提供止血。本发明的基质因改善的拉伸强度而为尤其有利的，特别是相对于由一层或多层纤维素材料制成或包含一层或多层纤维素材料例如氧化再生纤维素的止血基质而言。例如，可利用该敷料以从组织密封气体或从器官和组织密封流体，所述流体包括但不限于胆汁、淋巴液、脑脊髓液、胃肠液、间隙液和尿液。
本文所述的止血器具有附加的医学应用并且可用于多种临床功能，所述临床功能包括但不限于基质/基底(即纤维蛋白原/凝血酶)涂布、组织强固和支持(即对于胃肠道或血管愈合)、组织拉近(即连接难以执行的愈合(即在张力状态下))、以及张力释放。在所有上述情况下，止血基质可附加地促进并且可能改善自然组织愈合过程。该敷料可在体内用于多种外科，包括但不限于心血管、外周血管、心胸、妇科、神经和普通外科。该止血器也可用于将医疗装置(例如，网、夹子和膜)附接至组织，将组织附接至组织，或将医疗装置附接至医疗装置。
实例1-PGLA的双层基质
将聚(乙交酯-丙交酯)共聚物(PGLA，90摩尔/10摩尔)熔纺成PGLA共聚物纤维。将得自PGLA共聚物纤维的多长丝纱线固结、卷曲、并且切割成具有2.0英寸长度的短纤维。短纤维被梳理成网以产生非织造棉絮，然后被压制成约1.0mm的厚度和约60mg/cc的密度。通过类似的工序来制备第二非织造棉絮，然后将其压制成约1.0mm的厚度和约120mg/cc的密度。然后将具有60mg/cc和120mg/cc的密度的两种非织造物针刺到彼此中，以固定非织造双层基质。
实例2在脾模型中实现止血的双层基质
通过在猪脾上制造15mm长且3mm深的切口来制备轻度到中度的出血模型。然后将如实例1所述的双层基质施用到外科部位并且填塞两分钟。在填塞两分钟之后的30秒内检查止血效果。如果在30秒内未观察到自流出血，则记录为止血时间。如果观察到自流出血，则再填塞30秒直至实现止血或者直至测试期达到十分钟(这被定义为止血失效)。从根据实例1制备的双层基质中切割出三个2.5×4.0厘米尺寸的测试样品，这三个测试样品均在5.62±0.76分钟内实现了止血(表1)。
表1.PGLA双层基质在脾模型中的止血
样品编号 1 2 3 平均值 SD
止血时间(分钟) 5.12 5.25 6.50 5.62 0.76
实例3
使用体外测试来表征根据实例1制备的双层基质的机械性能。将双层基质切割成条带(大约3/8英寸宽×2英寸长)。然后在干燥和润湿状况下利用英斯特朗拉伸测试仪来评估双层基质的拉伸强度。在润湿状况下，将条带放置在如下锥管中，所述锥管包含在37℃下pH为7.4的PBS缓冲液。然后在90分钟、4天、7天、11天和14天时测量条带的拉伸强度。双层基质的条带的拉伸强度的测量值示于表2中。
表2.双层基质在干燥和润湿状况下的拉伸强度

Claims (17)

1.一种合成织物，包含非织造基质，所述非织造基质具有由聚乙交酯/聚丙交酯共聚物的第一吸收性短纤维和聚乙交酯/聚丙交酯共聚物的第二吸收性短纤维构成的至少两层，其中所述第一吸收性短纤维的层被压制成60mg/cc的密度，并且所述第二吸收性短纤维的层被压制成120mg/cc的密度。
2.根据权利要求1所述的合成织物，其中所述第一吸收性短纤维的层和第二吸收性短纤维的层由在组合物中比例为90摩尔/10摩尔的乙交酯/丙交酯的共聚物组成。
3.根据权利要求1所述的合成织物，其中所述第一吸收性短纤维的层和第二吸收性短纤维的层由具有0.75-2.5英寸长度的短纤维构成。
4.根据权利要求3所述的合成织物，其中所述短纤维为卷曲的。
5.根据权利要求4所述的合成织物，其中所述第一吸收性短纤维的层被压制成0.5mm至1.5mm的厚度。
6.根据权利要求4所述的合成织物，其中所述第一吸收性短纤维的层被压制成1mm的厚度。
7.根据权利要求5所述的合成织物，其中所述第二吸收性短纤维的层被压制成0.75mm至3mm的厚度。
8.根据权利要求5所述的合成织物，其中所述第二吸收性短纤维的层被压制成1mm的厚度。
9.根据权利要求5所述的合成织物，其中第一吸收性短纤维的层和第二吸收性短纤维的层被针刺到彼此中。
10.根据权利要求9所述的合成织物，其中所述织物还包含至少一种止血剂。
11.根据权利要求10所述的合成织物，其中所述织物还包含纤维蛋白原和凝血酶作为止血剂。
12.根据权利要求11所述的合成织物，其中所述纤维蛋白原和凝血酶以冻干的粉末形式被设置在所述织物上。
13.根据权利要求12所述的合成织物，其中从所述第一吸收性短纤维的层的外表面到所述第二吸收性短纤维的层的外表面所测量，所述冻干的粉末为不均匀分散的。
14.权利要求13的合成织物在制备医疗装置中的用途。
15.根据权利要求14所述的用途，其中所述装置在被施用到需要止血的伤口时提供和维持有效止血。
16.根据权利要求14所述的用途，其中所述装置在1至10分钟的有效时间内控制和减轻轻度至中度出血。
17.根据权利要求1所述的合成织物，其中在英斯特朗拉伸测试仪中测量，3/8英寸宽至2英寸长的条带具有测得的下述拉伸强度（牛顿/厘米）：
a.  在干燥状况下为120；
b.  在润湿状况下90分钟为115；
c.  在润湿状况下4天为90；
d.  在润湿状况下7天为52；
e.  在润湿状况下11天为29；
f.  在润湿状况下14天为16。
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Families Citing this family (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2851095B1 (en) 2012-05-14 2021-07-14 Teijin Limited Sheet molding and hemostatic material
JP5927061B2 (ja) * 2012-06-22 2016-05-25 帝人株式会社 シート状止血材
CN104884694B (zh) * 2013-03-13 2018-09-11 麦瑞通医疗设备有限公司 连续沉积的纤维材料以及相关联的装置和方法
AT514063B1 (de) * 2013-03-26 2014-10-15 Bca Vertriebsgesellschaft M B H Absorptionsmaterial
US10363124B2 (en) 2014-09-18 2019-07-30 Humacyte, Inc. Methods and apparatuses for forming fibrous tubes
KR101878774B1 (ko) * 2015-04-15 2018-07-17 주식회사 삼양바이오팜 다기능성 지혈제 및 그 제조 방법
US10245034B2 (en) 2015-08-31 2019-04-02 Ethicon Llc Inducing tissue adhesions using surgical adjuncts and medicants
US10076329B2 (en) 2015-08-31 2018-09-18 Ethicon Llc Adjunct material to promote tissue growth in a colon
US10111661B2 (en) 2015-08-31 2018-10-30 Ethicon Llc Matrix metalloproteinase inhibiting adjuncts for surgical devices
US10194936B2 (en) 2015-08-31 2019-02-05 Ethicon Endo-Surgery, Llc Adjunct material for delivery to stomach tissue
US9937283B2 (en) 2015-08-31 2018-04-10 Ethicon Endo-Surgery, Llc Adjunct material to provide drug elution from vessels
US10285692B2 (en) 2015-08-31 2019-05-14 Ethicon Llc Adjuncts for surgical devices including agonists and antagonists
US10213520B2 (en) 2015-08-31 2019-02-26 Ethicon Llc Surgical adjuncts having medicants controllably releasable therefrom
US10086116B2 (en) 2015-08-31 2018-10-02 Ethicon Llc Adjunct material to provide controlled drug release
US10279086B2 (en) 2015-08-31 2019-05-07 Ethicon Llc Composite adjunct materials for delivering medicants
US10172973B2 (en) 2015-08-31 2019-01-08 Ethicon Llc Surgical adjuncts and medicants for promoting lung function
US10076324B2 (en) 2015-08-31 2018-09-18 Ethicon Llc Adjunct material to provide controlled drug elution
US10188390B2 (en) 2015-08-31 2019-01-29 Ethicon Llc Adjunct material to provide heterogeneous drug elution
US11020116B2 (en) 2015-08-31 2021-06-01 Ethicon Llc Surgical adjuncts with medicants affected by activators
US10349938B2 (en) 2015-08-31 2019-07-16 Ethicon Llc Surgical adjuncts with medicants affected by activator materials
US10499913B2 (en) 2015-08-31 2019-12-10 Ethicon Llc Tubular surgical constructs including adjunct material
US10188389B2 (en) 2015-08-31 2019-01-29 Ethicon Llc Adjunct material for delivery to colon tissue
US10463366B2 (en) 2015-08-31 2019-11-05 Ethicon Llc Adjunct materials for delivery to liver tissue
US10569071B2 (en) 2015-08-31 2020-02-25 Ethicon Llc Medicant eluting adjuncts and methods of using medicant eluting adjuncts
US10130738B2 (en) 2015-08-31 2018-11-20 Ethicon Llc Adjunct material to promote tissue growth
CA3004272C (en) 2015-11-06 2023-11-07 Ethicon, Inc. Compacted hemostatic cellulosic aggregates
EP3426207A1 (fr) * 2016-03-08 2019-01-16 Urgo Recherche Innovation et Développement Pansement se présentant sous la forme d'une bande autoadhérente
DK3325703T3 (da) 2016-08-02 2019-10-28 Fitesa Germany Gmbh System og fremgangsmåde til fremstilling af ikke-vævede polymælkesyrestoffer
CN107754005B (zh) 2016-08-15 2021-06-15 广州倍绣生物技术有限公司 止血组合物及其制造方法
US11413335B2 (en) 2018-02-13 2022-08-16 Guangzhou Bioseal Biotech Co. Ltd Hemostatic compositions and methods of making thereof
US11441251B2 (en) 2016-08-16 2022-09-13 Fitesa Germany Gmbh Nonwoven fabrics comprising polylactic acid having improved strength and toughness
US11254061B2 (en) 2017-01-06 2022-02-22 Ethicon, Inc. Scaffolds for implanting absorbable hemostats in field conditions

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0647734A1 (en) * 1993-10-06 1995-04-12 United States Surgical Corporation Absorbable non-woven fabric
CN101137402A (zh) * 2004-10-20 2008-03-05 伊西康公司 供医疗装置用的加固可吸收多层织物及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4626253A (en) 1984-10-05 1986-12-02 Johnson & Johnson Products, Inc. Surgical hemostat comprising oxidized cellulose
WO1993017635A1 (en) 1992-03-04 1993-09-16 C.R. Bard, Inc. Composite prosthesis and method for limiting the incidence of postoperative adhesions
CA2114282A1 (en) 1993-01-28 1994-07-29 Lothar Schilder Multi-layered implant
US20070225631A1 (en) 2002-10-04 2007-09-27 Bowlin Gary L Sealants for Skin and Other Tissues
AU2004206150B2 (en) * 2003-01-20 2009-10-29 Km Biologics Co., Ltd. Hemostatic materials
RU2005134239A (ru) * 2003-04-04 2006-05-10 Тиссьюмед Лимитед (Gb) Составы тканевых клеев
US7818350B2 (en) * 2005-02-28 2010-10-19 Yahoo! Inc. System and method for creating a collaborative playlist
WO2007117237A1 (en) * 2006-04-10 2007-10-18 Ethicon, Inc. A reinforced absorbable multilayered hemostatic wound dressing and method of making
US20080200890A1 (en) 2006-12-11 2008-08-21 3M Innovative Properties Company Antimicrobial disposable absorbent articles
JP2010069031A (ja) * 2008-09-19 2010-04-02 Chemo Sero Therapeut Res Inst シート状フィブリン糊接着剤

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0647734A1 (en) * 1993-10-06 1995-04-12 United States Surgical Corporation Absorbable non-woven fabric
CN101137402A (zh) * 2004-10-20 2008-03-05 伊西康公司 供医疗装置用的加固可吸收多层织物及其制备方法

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