CN100369637C - 医疗用薄膜 - Google Patents

医疗用薄膜 Download PDF

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CN100369637C
CN100369637C CNB2003801062594A CN200380106259A CN100369637C CN 100369637 C CN100369637 C CN 100369637C CN B2003801062594 A CNB2003801062594 A CN B2003801062594A CN 200380106259 A CN200380106259 A CN 200380106259A CN 100369637 C CN100369637 C CN 100369637C
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film
gelatin
reinforcing material
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medical
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CN1726056A (zh
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松田晶二郎
大谷齐
田中好
田所英记
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Gunze Medical Devices Shenzhen Ltd
Gunze Ltd
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/043—Proteins; Polypeptides; Degradation products thereof
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    • A—HUMAN NECESSITIES
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Abstract

本发明提供一种生物体适应性和生物体吸收性优良并且对缝合和粘结的强度也优良的医疗用薄膜。在明胶溶解液中配置生物体内分解吸收性高分子制的增强材料(12)，使上述增强材料(12)浸透在上述溶解液中，然后干燥上述明胶。由此在上述增强材料(12)内部的整个部分浸透的明胶后，凝胶化，形成明胶薄膜(11)，上述增强材料(12)和上述明胶薄膜(11)成为一体化的医疗用薄膜(1)。上述明胶薄膜(11)优选是交联过的明胶薄膜。

Description

医疗用薄膜
技术领域
本发明涉及医疗用薄膜，具体地讲，涉及生物体适应性、生物体吸收性和对缝合的强度优良、防止生物体组织彼此粘连的防粘连材料，和补充组织缺损部分的组织修复材料或者用于在体内移植片状组织的移植细胞培养用的片材。
背景技术
在心脏外科、整形外科、脑神经外科、腹部外科、产妇科等临床领域中，在各种外科手术后或者由于外伤，患病部位的生物体组织粘连(粘合)成为严重的问题。如果发生组织的粘连，例如会引起疼痛和功能障碍，在严重的情况下也需要进行另外用于剥离上述粘连的手术。并且，由于粘连，也产生所谓对于原来疾病的再次手术变得困难的问题。因此，目前为了防止生物体组织的粘连，开发了覆盖、保护可能会发生粘连的组织的防粘连材料，实际上再生氧化纤维素布和透明质酸和羧甲基纤维素混合膜等已经作为防粘连材料而被应用。
具体地讲，为了使上述防粘连材料起到上述防止粘连的功能，必需使上述防粘连材料在必要的期间内存在于可能会粘连的适用部位(患病部分)，作为上述适用部位组织间的屏障，然后最终分解并且被生物体吸收。即对于上述防粘连材料，要求生物体适应性、生物体吸收性等方面优良。
另外，即使上述生物体适应性等方面优良的防粘连材料，为了充分发挥这些功能，也必须牢牢地固定在上述适用部位，通常作为其固定化方法，可以使用通过缝合线缝合和通过粘结剂粘结等方法。
然而，上述目前的防粘连材料在例如生物体内、在必要的期间维持其形状的状态下发挥防粘连功能很困难的，并且，由于不具有能够经得住缝合和粘连等的强度，有时会破坏，操作和固定至适用部位也很困难。
例如近年来研究开发达到实用化的生物体适应性、生物体吸收性等方面优良的明胶薄膜制造的防粘连材料(例如参照特开平11-239610号公报和特开2000-37450号公报)，由于其自身粘结固定到适用部位的组织表面上的能力差，因此作为适用部位的固定，采用上述缝合和粘结的方法。但是，这种明胶薄膜如果适用于组织，则由于吸收上述组织的水分而变为含有水的水凝胶状态，因此存在所谓缝合固定困难的问题。
发明内容
因此，本发明的目的是提供例如生物体适应性、生物体吸收性优良并且对缝合和粘结的强度也优良的医疗用薄膜。
为了达到上述目的，本发明的医疗用薄膜是含有明胶薄膜的医疗用薄膜，还具有生物体分解吸收性高分子制的增强材料，上述增强材料配置在上述明胶薄膜的表面以及内部的至少之一的面方向的整个部分中，并且上述增强材料和明胶薄膜是被一体化的结构。还有在本发明中，上述明胶薄膜例如既可以是多孔质也可以是无孔的。
本发明的医疗用薄膜，通过在上述明胶薄膜的表面和内部，在其面方向的整个部分中配置上述生物体分解吸收性高分子制的增强材料并且上述两者一体化而赋予足够的强度，因此例如对适用部位的固定也变得容易，并且能够在必要的时间内保持其固定。因此在使用本发明的医疗用薄膜作为例如防粘连材料使用时，通过上述明胶薄膜形成的防粘连效果在适用部位上得到充分地发挥。并且，由于上述明胶薄膜的整体得到增强，因此可以切断成例如所需的形状和大小，对适用部位没有限制。另外，例如在适用部位上缝合固定医疗用薄膜后，需要再次将上述薄膜撕下，如上所述由于整体得到增强，也可以在上述薄膜的不同部分进行多次缝合。另外，上述增强材料是由在临床中实际使用的生物体适应性和生物体分解吸收性高分子制成，因此即使残存在生物体内也可以避免引起组织和异物的反应等。因而，本发明的医疗用薄膜例如作为防粘连材料在外科手术等临床领域中是非常有用的。
另外，本发明的医疗用薄膜并不局限于作为上述防粘连材料的使用，例如作为组织的修复材料、神经诱导管、移植细胞的培养用薄片、组织诱导再生膜等也是有用的。
附图说明
图1是表示一例本发明医疗用薄膜的平面图。
图2中的(A)和(B)是上述例子中的医疗用薄膜的剖面图。
图3是表示本发明医疗用薄膜的其它例子的剖面图。
图4是表示本发明医疗用薄膜的其它例子的剖面图。
图5是表示本发明医疗用薄膜的其它例子的透视图。
图6是表示本发明医疗用薄膜的其它例子的透视图。
图7是表示本发明医疗用薄膜的其它例子中使用的双系统编织物的示意图。
图8是表示在本发明的实施例中的医疗用薄膜的拉伸强度的图。
图9是表示本发明的实施例中的医疗用薄膜的穿丝张力的图。
图10是本发明的其它实施例中的各种增强材料的照片，(A)是双系统编织物的照片，(B)和(C)分别是经编针织物的照片。
图11是表示本发明的上述实施例中的切割复合物的图案的示意图。
图12是表示本发明的上述实施例中的切割复合物的图案的示意图。
图13是表示本发明的上述实施例中的切割复合物的图案的示意图。
具体实施方式
本发明的医疗用薄膜的形状没有特别地限制，除了片状外也可以是筒状。
在本发明的医疗用薄膜中，上述增强材料优选是织物体或者薄膜体，上述薄膜体既可以是例如多孔质薄膜，也可以是无孔质薄膜。
作为本发明的医疗用薄膜的形式，可列举出例如在明胶薄膜的至少之一的薄膜面上的整个部分层叠上述增强材料的层叠体。这时向上述明胶薄膜上配置上述增强材料的方法没有特别地限制，例如既可以通过粘结剂等使之一体化，也可以通过对上述增强材料的内部的至少一部分浸透明胶进行凝胶化，以使上述增强材料和上述明胶薄膜一体化。这样一来，只要在上述增强材料内部使明胶凝胶化，例如可以同时进行明胶薄膜的形成和一体化，并且，没有必要通过粘结剂等其它手段使得明胶薄膜和增强材料一体化，因此制造更加简便，并且可以牢固一体化。
并且，并不限于这样的形式，也可以是以下形式，例如在上述明胶薄膜的至少之一的薄膜面上，上述增强材料的一部分或者全部位于上述明胶薄膜内，通过对上述增强材料内部的一部分或者全部中浸透明胶进行凝胶化，而使得上述增强材料和上述明胶薄膜一体化。并且，也可以是以下形式，在明胶薄膜内部埋入上述增强材料的全部，通过在上述增强材料内部的全部中浸透明胶进行凝胶化，而使上述增强材料和明胶薄膜一体化。
在本发明的医疗用薄膜中，增强材料即上述织物体没有特别地限制，优选是无纺布、织物、编织物和编带，更优选是选自无纺布和织物的复合体、无纺布和编织物的复合体以及无纺布和编带的复合体中的至少一种。
上述织物和编织物的情况下，其丝的粗细没有特别地限制，例如在10～500d(11.1～555.6分特)的范围，优选在20～300d(22.2～333.3分特)的范围，特别优选为30～200d(33.3～222.2分特)。并且，作为丝的种类，可列举出例如复丝、单丝，其中优选的是复丝。
并且，在织物体例如是双系统(tiwn knit)编织布等上述编织物的情况下，其网眼单元(也称为“重复环”)的大小例如是纵向0.1mm～10mm、横向0.1mm～10mm，优选的是纵向0.3～8mm、横向0.3mm～8mm，更优选的是纵向0.5mm～6mm、横向0.5mm～6mm。还有所谓上述网眼单元，相当于例如在图7所示的双系统编织布的示意图中用矩形框架围成的部分。于是上述框架的长度相当于“单元的纵长”，上述框架的宽度相当于“单元的横长”。
在上述编织物为经编针织物的情况下，其网眼单元的大小例如是纵向0.1mm～10mm、横向0.1mm～10mm，优选的是纵向0.3～8mm、横向0.3mm～8mm，更优选的是纵向0.5mm～6mm、横向0.5mm～6mm。还有所谓经编针织物的网眼单元，相当于例如后述图10(B)、(C)照片中的菱形部分。于是上述菱形的纵向长度相当于“单元的纵长”，横向长度相当于“单元的横长”。并且，经编针织物的形式既可以是后述图10(B)中所示的“菱形孔网眼”，也可以是图10(C)中所示的“六角形孔网眼”。另外，有关菱形孔网眼和六角形孔网眼等代表的经编针织物的各种形式，公开在例如《针织物手册》(修订版，发行社：日本纤维研究所，发行日：昭和43年11月)中。
并且，作为上述无纺布，优选是通过例如熔喷法、针刺法、纺粘法、瞬时纺丝(flash spinning)法等方法制造的无纺布。
在本发明的医疗用薄膜中，上述增强材料优选经过热压处理。如果经过热压处理，则可以例如提高形成上述增强材料的纤维间的粘结性，并且，也可以抑制起毛。
并且，上述增强材料的性质和形状没有特别地限制，但是为了获得足够的强度，上述增强材料的单位面积重量优选在5～200g/m2的范围，其厚度优选在10～500μm的范围。
上述增强材料的穿丝张力优选在0.3～200N的范围内。该穿丝张力例如可以通过以下的方法求得。
(穿丝张力的测定方法)
准备试样(10mm×30mm)，固定上述试样的长度方向的两端使得两个夹具间距离变为20mm。首先，在距离上述试样拉伸方向中点的宽度方向端2mm处穿过带针的3-0尼龙丝(Nesco Suture、1/2圆形针)(商品名Nesco Suture；AZWELL公司制造)，在距离穿丝点50mm处固定丝的末端。然后固定上述试样，以100mm/min的速度拉伸丝的末端，通过测量装置(商品名Instron 4302：Instron公司制造)测定其最大张力(穿丝张力：单位N)。
在本发明的医疗用薄膜中，作为增强材料的上述薄膜体，没有特别地限制，例如可以使用通过加压法、浇铸(流延)法、挤压法等通常公知的方法所制造的薄膜体。并且，上述薄膜体的厚度，例如优选与上述织物体相同程度。并且，除了薄膜体之外也可以使用海绵体。
在本发明的医疗用薄膜中，上述生物体内分解吸收性高分子优选为选自聚乳酸、乳酸-己内酯共聚物以及聚乙二醇酸中的至少一个高分子，其中由于在形成增强材料时显示适度的分解吸收性，因此优选聚乳酸以及乳酸-己内酯共聚物。
在本发明的医疗用薄膜中，上述增强材料优选经过亲水化处理。这是由于通过使增强材料表面亲水化，上述增强材料容易与明胶水溶液或明胶薄膜亲和，因此和明胶薄膜的一体化也优良，增强材料很难从上述明胶薄膜上剥离。作为上述亲水化处理的方法，可列举出的是，例如等离子体处理、辉光放电处理、电晕放电处理、臭氧处理、表面接枝处理、涂覆处理、化学处理、紫外线照射处理等方法，其中优选等离子体处理。
在本发明的医疗用薄膜中，上述明胶薄膜优选是例如通过交联处理使经过所希望的时间后在生物体内分解的交联薄膜。这是由于在使用本发明的医疗用薄膜作为防粘连材料时，如上所述，必须在所需的时间内、存在于适用的部位并发挥防粘功能，并且经过上述期间后，为了避免组织和异物的反应，要求在生物体内被分解和吸收。还有明胶薄膜的交联度，其值相对越高，则表示在生物体内的分解越慢。
在本发明的医疗用薄膜中，上述明胶薄膜优选通过选自紫外线处理、热处理以及化学交联剂处理等手段中的至少一种方法进行交联。
在本发明的医疗用薄膜中，上述明胶薄膜优选在紫外线照射灯4～40W、照射时间0.1～100小时、照射距离5～100cm的条件下进行交联处理。并且，作为紫外线照射的条件，例如优选为紫外线强度0.05～50mW/cm2，紫外线累积光量1～100J/cm2，更优选的是紫外线强度0.5～10mW/cm2，紫外线累积光量5～100J/cm2。还有紫外线强度可以根据紫外线照射灯的“W”数和到被照射物(明胶薄膜)的距离来设定，紫外线累积光量用紫外线强度和照射时间的积表示，可以根据上述强度和时间来设定。还有紫外线处理，由于例如紫外线强度即紫外线照射灯功率、照射距离等各种条件的不同，交联程度不同，因此根据明胶薄膜所希望的分解时间，可以合适地确定上述条件。并且，紫外线照射也可以例如并列配置多个紫外线照射灯来进行。
在本发明的医疗用薄膜中，上述明胶薄膜在生物体内的存在时间优选在12小时～30天的范围内。在本发明中所谓“生物体内的存在时间”是指自从上述医疗用薄膜作为防粘连材料用于生物体内到在生物体内明胶薄膜被分解和吸收的时间(以下也称为“分解时间”)。另外，即使是相同的明胶薄膜，上述生物体内的存在时间也根据所适用的器官而不同，因此优选根据适用部位设定上述生物体内的存在时间。
在本发明的医疗用薄膜中，上述明胶薄膜的厚度从操作性等方面来看，优选在20～2000μm的范围内。
由于本发明的医疗用薄膜在生物体内适用，因此为了确保安全性，上述明胶中含有的内毒素浓度优选在超过0小于等于200EU/g，更优选在检测界限以下。还有内毒素的含量理想上是完全没有，即为0，但是由于实际上不是这样，因此其下限值定义为“超过0”。并且，本发明的医疗用薄膜优选不含有其它毒性物质，或者其含量不足法律或者医学上所容许的范围。
本发明中的明胶薄膜，如上所述由于适用部位不同，分解时间也不同，但是优选在12小时～90天内分解，更优选的是1～60天的范围，特别优选在2～30天的范围。分解时间如果在12小时或以上，可以充分地防止与组织的粘附，分解时间如果在90天或以下，特别是30天或以下，可以充分地防止粘附，并且在明胶薄膜的适用部位上不会发生防粘以外的反应(例如异物反应等)。该分解时间也可以根据后述的交联处理来设定。
上述明胶薄膜的厚度，例如可以根据适用部位和明胶薄膜所希望的分解时间等适当地确定，例如在20～2000μm的范围内，优选在30～500μm的范围内，更优选在50～300μm的范围内。上述明胶薄膜的厚度如果例如在20μm或以上，则形成强度更优良的薄膜，并且，厚度如果在2000μm或以下，则为柔软性优良并且操作容易的薄膜。
并且，在上述明胶薄膜中，通过以下方法测定的含水率例如为70～99％，优选为75～97.5％，更优选为80～95％。另外，上述含水率例如其值相对越低，则表示明胶薄膜在生物体内的分解越慢。并且，在明胶薄膜交联的情况下，上述含水率相对越低则表示其交联度越高、在生物体内的分解越慢。
上述含水率，例如首先在25℃的水中将上述薄膜浸渍12小时后，测定其湿润重量。接着使用真空干燥机使得该薄膜完全干燥，测定干燥后薄膜的干燥重量。然后将上述重量分别代入下式中，可以求得含水率。
含水率(％)＝100×[(湿润重量-干燥重量)/(湿润重量)]
作为明胶薄膜的原料，例如可以使用例如从牛、猪、马、鸡等哺乳类动物和鸟类等骨、腱、皮肤、鸡冠等中提取的明胶。这些明胶可以例如从上述动物中提取并调制，但是通常使用市场上出售的制品。上述提取方法没有特别地限制，可列举出的是例如目前公知的酸处理、碱处理等方法。
作为市场上出售的明胶，优选的是例如内毒素含量极少、安全性优良的碱处理明胶，具体地讲，可以例示的是Nippi公司制造的来自牛的碱处理明胶、来自猪的酸处理明胶、来自猪的碱处理明胶等。
并且，作为明胶薄膜的原料，除了明胶外，例如为了赋予薄膜柔软性，也可以使用甘油、聚乙二醇、透明质酸或者抗菌剂、抗炎症剂等添加物。
明胶薄膜可以通过例如浇铸法、挤压法等方法使得明胶薄膜化来制造，优选的是浇铸法。
通过上述浇铸法进行的薄膜化例如可以按照如下所示的方法进行。
首先将原料明胶溶解在加温状态的溶剂中。作为上述溶剂，可以使用例如蒸馏水、二甲亚砜(DMSO)等或者这些的混合液等，其中从操作性方面来看优选的是蒸馏水。明胶的添加比例，例如是每100mL溶剂为0.1～50g的范围，优选的是1～30g的范围，更优选的是3～20g的范围。溶解温度例如是10～80℃的范围，优选的是30～70℃的范围，更优选的是40～60℃的范围。并且，溶解时间，只要能够溶解上述明胶即没有特别地限制，例如为1分钟～100小时的范围，优选的是5分钟～50小时的范围，更优选的是10分钟～24小时的范围。
在含有上述明胶以外的添加物的情况下，其添加比例相对于1g明胶为例如1mg～20g的范围，优选的是5mg～10g的范围，更优选的是10mg～5g的范围。
通过将该明胶溶解液在培养皿中浇铸并且使之干燥，可以制造明胶薄膜。培养皿的大小没有特别地限制，可以根据所希望的薄膜长度、宽度和厚度等设定，并且，薄膜化后可以切割成所希望的大小使用。
上述明胶溶解液优选在例如每单位培养皿面积(cm2)为0.01～5mL的范围内流延，更优选是0.03～3mL的范围，特别优选是0.05～1mL的范围。
干燥条件可以通过自然干燥、加热干燥、减压干燥(真空干燥)、强制排气干燥、强制循环对流等进行。具体地讲，干燥温度例如是-40～90℃的范围，优选的是0～50℃的范围，更优选的是10～30℃的范围。并且，干燥时间例如是1～200小时的范围，优选的是3～100小时的范围，更优选的是5～48小时的范围。
上述一系列薄膜化工序，优选在例如干净的试验台上、干净的房间内无菌进行。这是因为防止由于操作中杂菌的繁殖而使得明胶薄膜污染。因此，所使用的制造器具，优选例如使用通过例如高压釜、EOG(环氧乙烷气体)、干热、电子线等灭菌处理的器具。并且，上述明胶溶解液也优选例如进行目前公知的过滤灭菌然后供给上述工序。
得到的明胶薄膜可以直接使用，但是如上所述由于可以将生物体内的分解时间设定为所希望的时间，因此优选再进行交联处理。
作为交联的方法，例如可以采用UV(紫外线)照射、热处理、化学交联处理等交联方法。作为上述化学交联剂，可列举出的是例如醛类、环氧类、碳化二亚胺类、异氰酸酯类、鞣酸、铬等。作为上述醛类，可列举出的是例如甲醛、戊二醛、酸醛、乙二醛、马来酸二醛、琥珀酸二醛、邻苯二甲酸二醛、二醛淀粉、聚丙烯醛、聚甲基丙烯醛等。并且，作为环氧类，可列举出的是例如甘油二缩水甘油醚、山梨糖醇二缩水甘油醚、乙二醇二缩水甘油醚、聚乙二醇二缩水甘油醚、聚甘油聚缩水甘油醚等。作为碳化二亚胺类，可列举出的是水溶性碳化二亚胺(例如1-乙基-3-(3-二甲氨基丙基)碳化二亚胺、环己基-3-(2-吗啉乙基)碳化二亚胺等)、二环己基碳化二亚胺等。这些化学交联剂只要能够交联上述明胶，其种类就没有特别地限制，例如可以使用一种，也可以结合使用2种或更多种。
在上述交联处理方法中优选UV照射、热处理、UV照射和热处理的结合使用。如果进行UV照射或者热处理，可以很容易地获得在以下效果方面更优良的交联明胶薄膜，例如在体内在较短的时间内分解，没有残存低分子的毒性化学物质，并且，也难以引起制品的变形。
在通过上述UV照射进行交联的情况下，例如UV照射灯功率、照射时间、照射距离等条件，可以根据明胶薄膜所希望的分解时间适当地决定。UV照射灯功率例如在4～40W的范围内，优选为8～30W的范围，更优选在12～20W的范围。照射时间例如在0.1～100小时的范围内，优选为0.5～60小时的范围，更优选为1～50小时的范围。照射距离例如在1～100cm的范围内，优选为5～90cm的范围，更优选为10～80cm的范围。
具体地讲，例如优选的是，在UV照射灯功率为4～40W范围的情况下，照射时间为0.1～100小时，照射距离为1～100cm的范围，更优选的是，在UV照射灯功率在8～30W范围的情况下，照射时间为0.5～60小时，照射距离为5～90cm的范围，特别优选的是，在UV照射灯功率在12～20W范围的情况下，照射时间为1～50小时，照射距离为10～80cm的范围。还有也可以通过并列多个照射灯进行配置，在短时间内更均匀地处理。
特别是对于在UV照射灯功率为15W、照射时间为5～30小时、照射距离为30～70cm的条件下制作的交联明胶薄膜，在发明者们进行的实验中，被证明是，在分解性、安全性、强度等上是更优异的薄膜。具体地讲，例如在UV照射灯功率为15W、照射时间为20小时、照射距离为60cm的条件下交联的厚度为100μm的交联明胶薄膜，在缝合在老鼠腹腔内的情况下约1周、在缝合在狗的心膜的情况下约4周以内分解消失。由此可以说，根据各种适用部位而设定所希望的分解时间，象这样地在上述条件下制作的交联明胶薄膜，特别是对于临床的实用性非常优良。
另外，作为上述热处理的条件，优选的是例如在真空条件下、60～180℃下处理5分钟～72小时。
其次，由于本发明中的上述增强材料特别是在手术时或者使用时直至明胶薄膜被吸收为止这段期间，是以增强为目的的，因此如果上述明胶薄膜发挥其作用并被分解吸收，则上述增强材料本身也没有必要残留在体内，并且，为了避免残留在体内、并会引起适用部位的组织和无用的异物反应，也要求被吸收分解。因此使用上述这样的生物体内分解吸收性的高分子制作的织物体和薄膜体等。
另外，增强材料既可以是一层，也可以是二层或以上的层叠体。在为层叠体的情况下，既可以由1种织物体或薄膜体构成，也可以由例如2种或更多种的织物体或薄膜体构成。
如上所述的那样，只要上述增强材料不残留在生物体内，对上述增强材料就没有特别地限制，但是由于作为增强材料使用，希望其具有某一程度的强度和柔软性并且具有分解性。并且，优选的是在临床应用中是具有生物适应性以及异物反应和炎症少的材料。为此作为上述生物体分解吸收性高分子，可列举出的是上述聚乳酸、乳酸-己内酯共聚物、聚乙二醇酸、乳酸-乙二醇酸共聚物、乳酸-乙二醇共聚物、聚二噁烷酮、乙二醇酸-己内酯共聚物、乙二醇酸-三亚甲基碳酸酯共聚物、乙二醇酸-二噁烷酮-三亚甲基碳酸酯共聚物、胶原、壳多糖、脱乙酰壳多糖、血纤维蛋白等，优选的是聚乳酸、乳酸-己内酯共聚物、聚乙二醇酸、胶原。
作为上述织物体的形式，如上所述可列举出织物、无纺布、编织物、平编带等编带等。其中优选无纺布，因为其具有细纤维彼此高度缠结的结构，没有方向性，且更优异的厚度设定的容易性和柔软性。并且，特别优选双系统编织物等编织物和织物，因为它们在厚度设定的容易性、柔软性、强度、穿丝张力方面更优良。再者，编织物、织物、编带中的任何一个和无纺布的一体化物(复合体)，由于兼有两者的优点，因此特别优选。
当增强材料为上述织物体时，其穿丝张力优选在例如0.3～200N的范围内，更优选为0.4～150N的范围，特别优选在0.5～100N的范围内。还有该值可以通过上述方法求得。
并且，上述织物体的单位面积重量，例如为5～200g/m2的范围，优选在8～80g/m2的范围，更优选在10～60g/m2的范围。
上述织物体根据上述明胶薄膜的大小和所希望的强度适当地决定，其厚度例如在10～1000μm的范围内，优选为20～800μm的范围，更优选为30～600μm的范围。并且，在为上述层叠体的情况下，其厚度例如优选在10～1000μm的范围内，更优选为20～800μm的范围，特别优选为30～600μm的范围。还有增强材料为薄膜体也是同样的。
上述无纺布，可以通过目前公知的方法即熔喷法、针刺法、纺粘法、瞬时纺丝法等方法制造。其中由于不使用溶剂，纤维的直径更小，细纤维高度缠结，可以很容易地制作薄布，因此特别优选熔喷法。
上述熔喷法是，例如通过将熔融的原料由挤压机的压模、以高速度的气流吹到累积筛子(accumulatings creen)上，使之交织来制造自粘性微纤维的纤维网的制造方法。
在制造上述聚乳酸制或者聚乙二醇酸制的无纺布情况下，使用分别以丙交酯或者乙交酯为原料进行聚合的聚合物，在制造乳酸-己内酯共聚物制的无纺布情况下，使用混合并聚合丙交酯和己内酯的共聚物。这时丙交酯(A)和己内酯(B)的摩尔比(A∶B)是，例如A∶B＝85∶15～40∶60的范围，优选是82∶18～42∶58的范围，更优选的是80∶20～45∶55的范围。
通过上述方法制作的无纺布等织物体，也可以直接作为本发明医疗用薄膜中的增强材料使用，但是如上所述那样，为了抑制起毛等线头的产生以及更进一步提高纤维间的粘结性，优选再进行热压加工。
上述热压处理，例如既可以在形成无纺布的纤维网之后立即进行，也可以在真空干燥处理后进行。另外，该处理优选在上述无纺布等的增强材料的双面上进行。
在形成上述纤维网之后立即进行的情况下，其条件是例如温度为65～95℃的范围、压力为0.01～5Mpa的范围，优选的是温度为70～85℃的范围、压力为0.05～2Mpa的范围，更优选的是温度为75～80℃的范围、压力为0.1～1Mpa的范围。
另一方面，在后一种情况下，首先例如在以下条件下进行上述真空热干燥处理。干燥温度在例如40～135℃的范围内，优选在50～125℃的范围内，更优选在60～115℃的范围内。并且，干燥时间在例如1～70小时的范围内，优选在5～50小时的范围内，更优选在10～30小时的范围内。
接着优选在以下条件下进行热压处理。处理条件是例如温度为80～110℃的范围、压力为0.01～5Mpa的范围，优选的是温度为85～105℃的范围、压力为0.05～2Mpa的范围，更优选的是温度为90～100℃的范围、压力为0.1～1Mpa的范围。上述加热温度如果在80℃或以上，能够充分地消除起毛，并且，如果在110℃或以下，可以保持优良的柔软性。
并且，如上所述那样，在增强材料是由例如2个或更多个织物体组成的二层或以上的层叠体的情况下，可以重合织物体之后进行热压处理而使之一体化。
并且，为了提高与明胶薄膜的粘结性，增强材料优选进行亲水化处理。作为亲水化处理，可列举出，如上所述的等离子体处理和辉光放电处理、电晕放电处理、臭氧处理、表面接枝处理、涂覆处理、化学处理、紫外线照射处理等，特别优选等离子体处理。
等离子体处理的条件没有特别地限制，优选的是例如在压力为1.33～1330Pa的氧气氛围中、温度为0～100℃的范围、功率为5～200W的范围，更优选的是在5～500Pa的氧气氛围中、温度为10～50℃的范围、功率为10～100W的范围。并且，处理时间可以在例如1秒钟～1000秒钟的范围内进行，优选为3秒钟～600秒钟的范围。
该等离子体处理，除了上述氧气以外，也可以使用例如空气、氮气、氩气、氦气、氨气、一氧化碳、水蒸气。
本发明的医疗用薄膜的整体形状和整体大小没有特别地限制，例如可以根据适用的部位适当地决定。例如整体长度为0.5～50cm的范围，整体宽度0.3～20cm、整体厚度20～2000μm。并且，优选的是整体长度为0.7～30cm的范围，整体宽度0.4～15cm、整体厚度30～500μm，更优选的是整体长度为1～20cm的范围，整体宽度0.5～10cm、整体厚度50～200μm。
上述增强材料的大小，例如根据适用部位和明胶薄膜的大小适当地决定。并且，其厚度优选在10～1000μm的范围，更优选在20～800μm的范围，特别优选在30～600μm的范围。
上述医疗用薄膜，如上所述，由于含有增强材料，其穿丝张力优选在例如0.20～200N的范围，更优选在0.25～150N的范围，特别优选在0.30～100N的范围。
作为在上述交联明胶薄膜上配置上述增强材料的方法，可列举出的是例如以下所示的4种方法。
在第1方法中，首先将上述明胶溶解液在上述培养皿中浇铸，使得增强材料浸渍在其中，上述明胶溶解液渗入到上述增强材料的内部。这时，为了使得明胶溶液充分渗入到上述内部，优选对增强材料进行亲水化处理或者脱气处理上述明胶溶液。然后与上述同样使得上述明胶凝胶化并且干燥。由此在形成明胶薄膜的同时，在增强材料内部的明胶也凝胶化，从而可以制作增强材料和明胶薄膜一体化的医疗用薄膜。具体地讲，例如如图1的剖面图所示，在增强材料12内部，明胶11发生凝胶化形成明胶薄膜，成为上述增强材料和上述明胶薄膜一体化的单层体形式。还有为了显示上述增强材料12内部中的凝胶化的明胶的存在，图1中的圆点示意地表示明胶，在后述图2～图4中也一样。
另外，作为通过第1方法制造的医疗用薄膜，也可以是例如图2(A)、(B)的剖面图中所示的形式。
例如图2(A)中所示的医疗用薄膜是，在明胶薄膜21的内部含有增强材料22，通过使上述增强材料22的全部浸透明胶进行凝胶化，从而使得上述增强材料22和明胶薄膜21成为一体化的形式。在使用这种形式的医疗用薄膜2的情况下，例如通过调整上述明胶溶液的量和明胶浓度，可以形成比增强材料22还厚的明胶薄膜21(医疗用薄膜2的厚度)。另外，例如在干燥状态下，明胶薄膜的厚度也比增强材料的厚度要薄，优选通过在使用时上述明胶薄膜吸收水分而成为含水状态，从而成为比上述增强材料厚的明胶薄膜。
并且，例如图2(B)中所示的医疗用薄膜是在明胶薄膜21的内部埋入全部增强材料22，通过使得上述增强材料22的全部浸透明胶进行凝胶化，从而使得上述两者成为一体化的形式。这种形式的医疗用薄膜，可以通过例如在明胶溶液固化前浸渍增强材料，再将同样的明胶溶液从上述增强材料的上面供给，使得上述明胶溶液完全固化来制造。这样地，如果在明胶薄膜的内部埋入增强材料，医疗用薄膜的双面仅仅用明胶薄膜形成，因此例如可以使得适用部位的整个表面仅仅与医疗用薄膜中的明胶薄膜接触。
对于第2个方法，首先将上述明胶溶解液在上述培养皿中浇铸，上述明胶开始凝胶化。然后，在明胶完全凝胶化之前，将增强材料放在凝胶化前的明胶上，再完全凝胶化并使之干燥。如果这样的话，上述明胶溶解液部分浸透到上述增强材料内部，因此在形成明胶薄膜的同时，在增强材料的内部也发生明胶凝胶化。由此如图3的剖面图中所示，可以制作医疗用薄膜3，其是由上述增强材料32和明胶薄膜31通过上述增强材料32内的明胶一体化而成的。另外，对这种方法没有特别地限制，例如通过将增强材料放入容器中，从上面供给明胶溶液等，同样也可以制造上述图3中所示形式的医疗用薄膜。
按照该方法，由于例如在增强材料内部充分浸透了上述明胶溶解液，因此不需要进行上述脱气处理等，可以比上述第1个方法更简便地进行一体化。
对于第3个方法，是例如将与上述第2个方法同样形成的增强材料和明胶薄膜的复合体再浸渍在明胶溶解液中，以使上述增强材料处于面对所述明胶溶解液，然后再干燥的方法。由此如图4中所示，可以获得上述增强材料42埋入在明胶薄膜41、43内的结构的医疗用薄膜4。然后，将形成明胶薄膜41时的明胶溶解液和形成明胶薄膜43时的明胶溶解液浸透在上述增强材料42中，在增强材料42内部明胶变为固化的状态。还有在同一图中，明胶薄膜41和43通过第2次凝胶化，通过增强材料42内部的明胶而被一体化。根据在这种结构的医疗用薄膜，例如增强材料没有暴露在其表面上，因此可以使得明胶薄膜与适用部位的整个表面接触。
对于第4个方法，预先在对置的两个玻璃板之间保持着所希望形状的无纺布，以使它们具有所希望的厚度，在上述玻璃板间浇铸上述明胶溶解液，将其冷却凝胶化后再干燥的方法。该情况下，明胶溶解液也部分浸透到上述增强材料中，然后凝胶化，因此可以获得增强材料和明胶薄膜一体化的医疗用薄膜，与通过上述第3个方法得到的医疗用薄膜一样，由于增强材料没有暴露在其表面上，因此例如可以使得明胶薄膜与适用部位的整个表面接触。并且，按照该方法，可以使得医疗用薄膜的厚度更加均匀。
以上这样的方法，利用明胶溶解液浸透到增强材料中，由于明胶在上述增强材料内部的全部或者部分也发生了明胶的凝胶化，因此可以充分地进行明胶薄膜和增强材料的一体化，由此得到的医疗用薄膜，例如在使用时增强材料没有剥离，并且对医疗用薄膜的缝合等可以保持优良的强度。此外，对于上述一体化，并不局限于上述方法，例如也可以通过粘结剂等进行。并且，在上述一体化之后，还可以再进行上述交联处理。
并且，对于本发明的医疗用薄膜，可以直接以片状的形式使用如上所述在明胶薄膜上配置上述增强材料的薄膜，例如也可以是预先为筒状的形式(以下称为“筒状医疗用薄膜”)。
这种筒状医疗用薄膜，可以作为例如腱、神经、卵管等的防粘连材料或者神经的诱导管使用。具体地讲，例如在将切断的神经两末端嵌入到上述筒状医疗用薄膜的筒内的状态下，缝合神经和上述筒状医疗用薄膜。
上述筒状医疗用薄膜，是例如如图5透视图中所示，在筒状的增强材料52的外周配置有明胶薄膜51的结构。其大小没有特别地限制，例如可以根据适用的部位适当地决定。例如整体长度为0.3～30cm的范围，内部直径为1mm～1cm的范围，明胶薄膜和增强材料的厚度与上述一样。
这种筒状医疗用薄膜，例如可以按照以下方法制作。首先准备长方形的明胶薄膜，在其一方的整个表面上配置增强材料形成层叠体。然后将其卷成筒状，使上述层叠体的宽度方向的端部重叠，用粘结剂粘结或者用生物体吸收性缝线缝合，可以得到筒状医疗用薄膜。还有在本发明的医疗用薄膜中，增强材料可以配置在筒状的明胶薄膜的内表面和外表面的任何一处，但是考虑到明胶薄膜发挥防粘效果，在筒的内部插入切断的神经等以及防止与外部的粘结，优选的是如图5中所示，在增强材料52的外周配置明胶薄膜51。并且，虽然未图示，但是也优选的是，例如如上述图2(B)和图4中所示，在明胶薄膜内部埋入增强材料的薄膜，与上述图5同样成为筒状形式的医疗用薄膜。只要是这种医疗用薄膜，由于表面全部是明胶薄膜，因此可以使得明胶与适用部位的整个表面接触。
上述筒状医疗用薄膜并不局限于上述制作方法，例如也可以将明胶薄膜卷成筒状，通过粘结剂和上述明胶的凝胶化等粘结并形成筒状体，然后在其一方的整个表面上配置增强材料。并且，也可以通过将明胶和增强材料放置在筒状压模中，使得明胶凝胶化，接着干燥而得。
并且，上述片状医疗用薄膜在使用时也可以作为筒状体使用。例如如图6的透视图所示，将在明胶薄膜61一方的整个表面上配置增强材料62的医疗用薄膜卷筒，在缝合切断的腱等之后将其卷入使其覆盖在上述缝合部位，在重叠的部分缝合，从而可以作为筒状体使用。
实施例
(实施例1)
织物体的制造
使用乳酸-己内酯共聚物复丝(粗细：42分特(dtex))，制造网眼大小在纵方向和横方向上均为3.5mm的双系统编织物(厚度200μm)和网眼大小在纵方向和横方向上均为1.5mm的双系统编织物(厚度200μm)。Dtex(分特：1分特＝1.111×旦)是粗细的国际单位。如上所述，图7中表示双系统编织物的织物组织的示意图。将该双系统编织物夹在2个玻璃板间，在120℃下真空加热处理3小时。接着对加热处理后的双环织物体，在室温、氧气67Pa(0.5托)、50W、30秒的条件下进行等离子体处理。
与明胶薄膜的一体化
将上述得到的各种织物体切成长度方向9cm、宽度方向7cm的长方形。
接着将切好的上述织物体(网眼：纵3.5mm×横3.5mm)放入培养皿(大小14cm×10cm)中，浇铸溶解在蒸馏水中的明胶含量为10重量％的明胶溶解液，使上述织物体浸渍在上述明胶溶液中。然后将它们直接风干，得到上述织物体和明胶薄膜一体化的复合体。这时通过将浇铸的明胶溶液的量改变为15ml、25ml、35ml，制作总厚度不同的三种复合体。另外，这三种复合体中不含有构成织物体网眼的丝的部分(网眼环的空隙部分)的厚度分别为90μm、150μm和210μm。并且，使用织物体(网眼：纵方向1.5mm×横1.5mm)同样制作复合体(明胶溶液35ml)。上述各个复合体的双面通过杀菌灯(东芝公司制造、GL-15、波长254nm、紫外线照射灯功率15W、照射距离45cm)，每个照射10小时紫外线进行交联处理。由此可以调制增强材料埋入在明胶薄膜内的复合体。另外，随着多使用的明胶溶液量的增多，复合体的厚度也变厚。
对于得到的各个实施例的各种复合体(医疗用薄膜)，通过以下方法测定拉伸张力和穿丝张力。另外，作为比较例1，除了不含有织物体以外，与上述同样使明胶溶液干燥并交联，制作上述三种厚度的薄膜，同样地进行测定。
拉伸强度的测定方法
将上述复合体在25℃的生理盐水中浸渍40分钟后，切成10mm×30mm的大小作为试样。还有针对各复合体调制以下两种试样：沿着上述织物体网眼的纵方向切成长度为30mm、沿着横方向切成长度为10mm的试样(试样A)，和沿着上述纵方向切成长度为10mm、沿着横方向切成长度为30mm的试样(试样B)。然后固定上述各试样长度方向的两端，以使2个夹头(chuck)间距离为10mm。然后将这些试样以100mm/min的速度拉伸，通过测定装置(商品名Instron 4302：Instron公司制造)测定上述试样破裂时的张力。并且，对于1种试样进行5次测定，求其平均值，并基于以下评价基准进行评价。在下述评价中，如果是评价A和B，则可以充分地实际应用。这些结果显示在图8和下述表1中。在上述图8中，所谓显示样品大小的“纵”是指沿着上述织物体网眼的纵方向的长度，所谓“横”是指沿着上述网眼的横方向的长度。
A：即使加上2N或以上的张力，增强材料也不破裂。
B：即使加上1N的张力，增强材料也不破裂。
C：加上1N或以下的张力，增强材料即破裂。
穿丝张力的测定方法
与上述拉伸张力的测定方法同样地调制试样。然后固定上述各试样长度方向的两端以使2个夹头间距离为20mm。接着，在距离上述试样拉伸方向中点的宽度方向端2mm处，穿过带针的3-0尼龙丝(NescoSuture、1/2圆形针)(商品名Nesco Suture；AZWELL公司制造)，在距离穿丝点50mm(相对试样厚度方向垂直的方向)处固定丝的末端。然后，固定上述试样，并以100mm/min的速度拉伸丝的末端，通过测量装置(商品名Instron 4302：Instron公司制造)测定其最大断裂强度(穿丝张力)。还有对于1种试样进行5次测定，求其平均值并且基于以下评价基准进行评价。在下述评价中，只要是评价A～C，则能充分地实际应用。这些结果显示在图9和下述表1中。在图9中，所谓显示样品大小的“纵”是指沿着上述织物体网眼的纵方向的长度，所谓“横”是指沿着上述网眼的横方向的长度。
A：即使加上2N或以上的张力，增强材料也不破裂。并且，增强材料也不会从明胶中露出。
B：即使加上1N～2N的张力，也不会发生增强材料的破裂和露出。
C：即使加上0.4N～1N的张力，也不会发生增强材料的破裂和露出。
D：加上0.4N或以下的张力，增强材料破裂或者增强材料从明胶中露出。
  织物体的网眼大小(纵(mm)×横(mm))   明胶溶液量(ml)   样品的大小(纵(mm)×横(mm))   拉伸强度   穿丝张力
  (N)   评价   (N)   评价
 实施例1   试样A试样A试样A试样A试样B试样B试样B试样B   3.5×3.53.5×3.53.5×3.51.5×1.53.5×3.53.5×3.53.5×3.51.5×1.5   1525353515253535   30×1030×1030×1030×1010×3010×3010×3010×30   3.1634.6156.4675.0781.6991.5841.6992.568   AAAABBBA   1.9262.2152.1102.0730.57330.95750.95261.267   BAAACCCB
 比较例1   ---   152535   30×1030×1030×10   0.41550.36360.9947   CCC   0.20480.23720.3793   DDD
由图8、图9和上述表1中所示，可以看出上述增强材料和明胶薄膜一体化的复合体(医疗用薄膜)，与比较例的明胶薄膜相比，拉伸强度和穿丝张力极高，由此表明通过上述增强材料使得复合体被充分增强。另外，通过减小增强材料网眼的大小，可以减少复合体在纵方向和横方向上的断裂强度的差异。因此可以说不用考虑增强材料的方向来使用是有用的。并且，通过改变明胶溶液的量使明胶薄膜的厚度变厚，可以进一步提高强度。
(实施例2)
作为织物体，使用如下所示的双系统编织物、经编针织物制成复合体薄膜，确定其强度。另外，所使用的乳酸-己内酯共聚物复丝是通过使用丙交酯(乳酸的二聚物)和己内酯的组成比(摩尔比)为75∶25的乳酸-己内酯共聚物，按照公知的方法(参照例如特开平08-317968号公报)调制而成。
增强材料
(双系统编织物2-1)
使用乳酸-己内酯共聚物复丝(粗细：75分特(dtex))，制作网眼大小为纵方向2.7mm、横方向3.1mm的双系统编织物。该双系统编织物2-1的编织组织的照片如图10(A)中所示(25倍放大照片)。
(双系统编织物2-2)
使用乳酸-己内酯共聚物复丝(粗细：67分特(dtex))，制作网眼大小为纵方向2.7mm、横方向3.1mm的双系统编织物。并且双系统编织物2-2的编织组织与上述图10(A)一样。
(经编针织物2-3)
使用乳酸-己内酯共聚物复丝(粗细：33分特(dtex))，制作网眼大小为纵方向4.2mm、横方向3.9mm的经编针织物(菱形孔网)。该经编针织物2-3的编织组织的照片如图10(B)中所示(25倍放大照片)。
(经编针织物2-4)
使用与经编针织物2-3同样的复丝，制作网眼大小为纵方向5.1mm、横方向2.7mm的经编针织物(六边形孔网)。该经编针织物2-3的编织组织的照片如图10(C)中所示(25倍放大照片)。
和明胶薄膜的一体化
在这样制作的增强材料样品(上述双系统编织物2-1、2-2、经编针织物2-3、2-4)中，与实施例1同样地进行真空加热处理和等离子体处理。然后将这些样品分别放入培养皿(大小13.6cm×9.6cm)内后，浇铸溶解在蒸馏水中的明胶含量为5重量％的50ml明胶溶解液，使得上述增强材料样品浸渍在上述明胶溶液中。然后将这些直接风干，得到上述增强材料样品和明胶薄膜一体化的复合体。这时得到的复合体中，不含有构成上述增强材料样品的网眼的丝的部分(网眼环的空隙部分)的厚度约为160μm。对于得到的上述各个复合体的的双面，通过杀菌灯(东芝公司制造、GL-15、波长254nm、紫外线照射灯功率15W、照射距离45cm)，每个照射10小时紫外线进行交联处理。由此可以调制增强材料埋入在明胶薄膜内的复合体。
接着将调制好的各个复合体切成长度3cm×宽度1cm大小，作为复合体样品。使用了经编针织物的复合体的切割方向如图11中所示，使用了经编针织物的复合体的切割方向如图12、图13的示意图所示。在图11中，用圆围成的部分是表示双系统编织物的编织组织结构的放大示意图。另外，图11～图13仅仅用来图示相对于网眼如果在方向上进行切割，切割部分的大小和网眼的大小、网眼数等并不局限于此，并且，省略了编织图案的详细描述。在图11中，切割部分91称为水平型样品，切割部分92称为垂直型样品，在图12中，切割部分93称为水平型样品，切割部分94称为垂直型样品，在图13中，切割部分95称为第1斜型样品，切割部分96称为第2斜型样品。
针对切好的各个复合体样品(医疗用薄膜)，测定拉伸强度和穿丝张力。作为这些测定时的条件，除了使用25℃的10mM磷酸缓冲液(PBS(磷酸盐的缓冲盐水)：pH7.4)代替生理盐水作为浸渍复合体的溶液，在穿丝张力的测定中使用带针的5-0尼龙丝(商品名Nesco Suture、1/2圆形针；AZWELL公司制造)代替带针的3-0尼龙丝以外，与上述实施例1同样。还有在穿丝张力的测定方法中，在距离试样拉伸方向中点的宽度方向2mm的部位，通过上述尼龙丝使之穿在形成增强材料的丝上。这时对于图11中所示的双系统编织物的水平型样品91和垂直型样品92，在宽度方向的两端测定穿丝张力。各个样品中的丝的拉伸方向如图11～图13的各个箭头所示，具体地讲，如图11中所示，双系统编织物的水平型样品91按照箭头91a、91b的方向，垂直型样品92按照箭头92a、92b的方向拉伸穿丝，如图12中所示，经编针织物的水平型样品93按照箭头93a的方向，垂直型样品94按照箭头94a的方向拉伸穿丝，如图13中所示，经编针织物的第1斜型样品95按照箭头95a的方向，第2斜型样品96按照箭头96a的方向拉伸穿丝。
并且，作为参考例，使用心膜片即厚度为0.1mm的商品名Core-TexEPTFE膜片II(心膜片)(Core-Tex公司制造)，同样进行试验。这些结果如下述表2中所示。还有在表2中，所谓穿丝张力一列中的“箭头”表示图11～图13中所示各个样品中丝的拉伸方向。
增强材料种类 复合体样品   拉伸强度   箭头   穿丝张力
  (N)   评价   (N)   评价
实施例2 双系统编织物2-1 水平型垂直型 4.913.45 AA   91a91b92a92b   0.981.851.793.47   CBBA
双系统编织物2-2 水平型垂直型 5.792.16 AA   91a91b92a92b   0.621.862.322.59   CBAA
  经编织物2-3   水平型垂直型第1斜型第2斜型   7.622.256.676.35   AAAA   93a94a95a96a   2.132.763.841.84   AAAB
  经编织物2-4   水平型垂直型第1斜型第2斜型   9.351.956.617.05   ABAA   93a94a95a96a   2.433.293.782.46   AAAA
 参考例1   -   水平型垂直型   22.8223.87   AA   3.263.52   AA
如表2中所示，在使用双系统编织物和经编针织物作为增强材料的情况下，复合物显示足够的强度，特别是在使用经编针织物作为增强材料的情况下，经编针织物的丝不会解开并且显示极其优良的穿丝张力和拉伸强度。其中经编针织物2-4(六边形网)在编织物组织中的交叉部分中的丝的缠绕较多，因此与其它增强材料相比，即使在任何方向上穿丝，也显示优良的穿丝张力。并且，虽然双系统编织物2-1、经编针织物2-3和经编针织物2-4各自具有方向性，但是根据穿丝的那些可以得到比参考例更优良的穿丝张力，特别是经编针织物2-3、2-4的各个样品94显示极其优良的穿丝张力。另外，实施例2中的各个复合体与表1中的比较例1相比，也显示极其优良的拉伸强度和穿丝张力。由以上结果可以看出，通过使得增强材料和明胶薄膜一体化，可以显示优良的强度，特别是在使用经编针织物作为增强材料的情况下，由于显示极其优良的强度，因此作为医疗用薄膜是有用的。
如上所述，本发明的医疗用薄膜可以可靠地固定在生物体内预定的位置上，例如可以有效地防止一般组织的粘结。并且，通过将其形状制成圆筒状，作为例如腱、神经、卵管等的防粘连材料、神经的诱导管等也是有用的。并且在完成防粘等功能之后，由于在生物体内被分解吸收，因此在安全性方面也没有问题。

Claims (27)

1.一种含有明胶薄膜的医疗用薄膜，其进一步具有生物体分解吸收性高分子制的增强材料，所述增强材料配置于所述明胶薄膜的表面以及内部的至少之一的面方向的整个部分，并且所述两者被一体化，在所述明胶薄膜的至少之一的薄膜表面上，所述增强材料的一部分或者全部位于所述明胶薄膜内，通过在所述增强材料内部的一部分或者全部中浸透明胶而凝胶化，使所述增强材料和所述明胶薄膜一体化。
2.一种含有明胶薄膜的医疗用薄膜，其进一步具有生物体分解吸收性高分子制的增强材料，所述增强材料配置于所述明胶薄膜的表面以及内部的至少之一的面方向的整个部分，并且所述两者被一体化，所述增强材料的全部被埋入到所述明胶薄膜内部，通过在所述增强材料内部的全部中浸透明胶而凝胶化，使得所述增强材料和所述明胶薄膜一体化。
3.根据权利要求1或2所记载的医疗用薄膜，在整个所述明胶薄膜的至少之一的薄膜表面上层叠有所述增强材料。
4.根据权利要求1或2所记载的医疗用薄膜，其形状是片状或者圆筒状。
5.根据权利要求1或2所记载的医疗用薄膜，其中增强材料是选自织物体、薄膜体和海绵体中的至少一种。
6.根据权利要求5所记载的医疗用薄膜，其中织物体是选自无纺布、织物、编织物和编带中的至少一种。
7.根据权利要求5所记载的医疗用薄膜，其中织物体是选自无纺布和织物的复合体、无纺布和编织物的复合体以及无纺布和编带的复合体中的至少一种。
8.根据权利要求6所记载的医疗用薄膜，其中织物体是通过选自熔喷法、针刺法、纺粘法和瞬时纺丝法中的至少一种方法制造的无纺布。
9.根据权利要求6所记载的医疗用薄膜，其中织物体是编织物、经编针织物和双系统编织物中的至少一种。
10.根据权利要求1或2所记载的医疗用薄膜，其中增强材料经过热压处理的。
11.根据权利要求1或2所记载的医疗用薄膜，其中增强材料的单位面积重量在3～200g/m2的范围内。
12.根据权利要求1或2所记载的医疗用薄膜，其中增强材料的厚度在10～1000μm的范围内。
13.根据权利要求1或2所记载的医疗用薄膜，其中增强材料的穿丝张力在0.3～200N的范围内。
14.根据权利要求1或2所记载的医疗用薄膜，其中生物体内分解吸收性高分子为选自聚乳酸、乳酸-己内酯共聚物以及聚乙二醇酸中的至少一种。
15.根据权利要求14所记载的医疗用薄膜，其中乳酸-己内酯共聚物中的丙交酯(A)和己内酯(B)的摩尔比在A∶B＝85∶15～40∶60的范围。
16.根据权利要求1或2所记载的医疗用薄膜，其中增强材料经过亲水化处理。
17.根据权利要求16所记载的医疗用薄膜，其中亲水化处理的方法是选自等离子体处理、辉光放电处理、电晕放电处理、臭氧处理、表面接枝处理、涂覆处理、化学处理和紫外线照射处理中的至少一种。
18.根据权利要求1或2所记载的医疗用薄膜，其中明胶薄膜是交联过的明胶薄膜。
19.根据权利要求18所记载的医疗用薄膜，其中明胶薄膜是通过选自紫外线处理、热处理以及化学交联剂处理中的至少一种处理方法进行交联。
20.根据权利要求19所记载的医疗用薄膜，其中明胶薄膜经过紫外线处理和热处理。
21.根据权利要求19或20所记载的医疗用薄膜，其中明胶薄膜在紫外线照射灯功率4～40W、照射时间0.1～100小时、照射距离5～100cm的条件下通过紫外线处理进行交联处理。
22.根据权利要求19或20所记载的医疗用薄膜，其中明胶薄膜在紫外线强度0.05～50mW/cm2，紫外线累积光量1～100J/cm2的条件下通过紫外线处理进行交联处理。
23.根据权利要求19或20所记载的医疗用薄膜，其中明胶薄膜在真空、60～180℃、5分钟～72小时的条件下通过热处理进行交联处理。
24.根据权利要求1～20任一项所记载的医疗用薄膜，其中明胶薄膜在生物体内的存在时间在12小时～90天的范围内。
25.根据权利要求1～20任一项所记载的医疗用薄膜，其中明胶薄膜的厚度在20～2000μm的范围内。
26.根据权利要求1～20任一项所记载的医疗用薄膜，其中明胶所含有的内毒素浓度在200EU/g或以下。
27.根据权利要求1～20任一项所记载的医疗用薄膜，其作为防粘连材料。
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