CN101035574B - 外科用丝网状植入物 - Google Patents
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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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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
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- A—HUMAN NECESSITIES
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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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
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- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
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- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
- C08L67/02—Polyesters derived from dicarboxylic acids and dihydroxy compounds
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- C—CHEMISTRY; METALLURGY
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- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
- C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F2250/0031—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
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- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
Abstract
外科假体,包括三维丝网,该丝网包括至少两种相互环绕或相互盘绕以界定至少两层的纱线,其中至少两层的其中一层基本上是非生物降解性的。粘连屏障与三维丝网的第二、基本上生物降解的层相互连接。
Description
技术领域
本发明涉及外科假体,尤其涉及用于修补体腔开口的外科假体。
背景
体腔内多余的开口,如切口疝,通常利用修补丝网,例如在PCT公开号WO01/43789和美国专利No.6,264,702中所描述的聚丙烯丝网或者包括可生物降解的粘连屏障层的聚丙烯丝网进行修补,以在壁开口处给体腔内表面加衬里。
概述
通常,在一方面,本发明公开了一种外科假体。该外科假体包括三维丝网,该丝网包括至少两种相互环扣或者相互缠绕的纱线从而界定出至少两层,其中所述至少两层中的一层基本上是非生物降解的,而所述至少两层中的另一层基本上是可生物降解的。将粘连屏障与三维丝网的第二、基本上可生物降解的层相互连接。
实施方案可包括下面特征中的一个或多个。三维丝网内的所述至少两种类型的纱线的其中一种是非生物降解性纱线。该非生物降解性纱线选自聚丙烯、聚对苯二甲酸乙二醇酯或其组合。该非生物降解性纱线具有大约0.001到大约0.010英寸的直径,并且优选为大约0.005英寸。
实施方案还可包括下面特征中的一个或多个。所述至少两种类型的纱线的其中一种是生物降解性纱线。该生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或其组合。该生物降解性纱线具有不超过大约120丹尼尔的直径。在某些实施方案中,该生物降解性纱线具有不超过大约100丹尼尔的直径。
在一些实施方案中,外科假体的三维丝网包括至少一种非生物降解的单丝纱线和至少一种生物降解的复丝纱线。在一些实施方案中,外科假体的三维丝网包括至少一种非生物降解的单丝纱线和至少两种生物降解的复丝纱线。
实施方案还可包括下面特征中的一个或多个。外科假体的粘连屏障包括聚合物水凝胶。该粘连屏障包括至少一种通过与碳二亚胺反应来改性的聚阴离子多糖。在一些实施方案中,该粘连屏障包括单独的交联的聚合物水凝胶或者包括和至少一种通过与碳二亚胺反应来改性的聚阴离子多糖相结合的交联的聚合物水凝胶。该交联的聚合物水凝胶包括一个或多个亲水嵌段、一个或多个生物降解性嵌段以及一个或多个交联性嵌段。该交联的聚合物水凝胶由包括可光聚合的用丙烯酸酯封端的聚乙二醇-碳酸亚丙酯/乳酸酯多嵌段聚合物的单体聚合而形成。通过与碳二亚胺反应来改性的聚阴离子多糖包括碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素。
实施方案还可包括下面特征中的一个或多个。该粘连屏障是薄膜、泡沫或者凝胶的形式。该粘连屏障具有每平方英尺大约5克总聚合物的密度。该外科假体具有小于约2%的湿含量。在一些实施方案中,该外科假体具有小于约1.2%的湿含量。
在另一方面,本发明公开了包括基本上由非生物降解性纱线构成的第一层、基本上由第一生物降解性纱线构成的第二层和嵌于第二层内的粘连屏障的外科假体。外科假体的第一和第二层用第二生物降解性纱线连接。第一层界定了该外科假体的第一外表面,而粘连屏障界定了该外科假体的第二外表面,其中第一外表面具有适于允许组织向内生长进入第一层的大孔结构,而该外科假体的第二外表面适于将邻近第二外表面的组织粘连的形成减到最小。
实施方案还可包括下面特征中的一个或多个。所述外科假体的第二外表面具有小孔结构,其具有大约10微米或者更小的孔尺寸。所述外科假体的第一外表面的大孔结构具有大约100微米或者更大的孔尺寸。
实施方案还可包括下面特征中的一个或多个。所述非生物降解性纱线选自聚丙烯、聚对苯二酸乙二醇酯或其组合。第一生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或其组合。第二生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或其组合。
实施方案还可包括下面特征中的一个或多个。所述粘连屏障包括交联水凝胶聚合物和至少一种通过与碳二亚胺反应来改性的聚阴离子多糖。该交联水凝胶聚合物包括一个或多个亲水嵌段、一个或多个生物降解性嵌段以及一个或多个交联性嵌段。在一些实施方案中,该交联水凝胶聚合物由包括可光聚合的用丙烯酸酯封端的聚乙二醇-碳酸亚丙酯/乳酸酯多嵌段聚合物的单体聚合而形成。通过与碳二亚胺反应来改性的聚阴离子多糖包括碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素。
通常,在另外的方面,本发明公开了制造外科假体的方法。该方法包括以下步骤:提供包括基本上由非生物降解性纱线构成的第一层和由生物降解性纱线构成的第二层的织物,提供包括大分子单体和引发剂的液体制剂,将所述织物放置在液体制剂中使得第二层与该液体制剂流体接触;并将该液体制剂暴露于光源。
实施方案还可包括下面特征中的一个或多个。所用的光源是具有大约1到大约100mW/cm2强度的LED阵列。在液体制剂中所用的引发剂是光敏引发剂,例如曙红Y。该液体制剂进一步包括生物高分子、促进剂和缓冲剂。该生物高分子包括至少一种通过与碳二亚胺反应来改性的聚阴离子多糖。该缓冲剂包括三乙醇胺和/或磷酸钾。该促进剂包括N-乙烯基己内酰胺。在一些实施方案中,该液体制剂包括1重量%的碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素,2.5重量%的用丙烯酸酯封端的聚乙二醇-碳酸亚丙酯/乳酸酯多嵌段聚合物,40ppm的曙红Y,4000ppm的N-乙烯基己内酰胺,0.54重量%的三乙醇胺,0.8重量%的磷酸钾。
在另一方面,本发明公开了制造外科假体的方法。该方法包括提供包括基本上由非生物降解性纱线构成的第一层和由生物降解性纱线构成的第二层的织物,提供包括第一聚合物体系、第二聚合物体系和光敏引发剂的液体制剂,将织物放置在液体制剂上使得第二层与该液体制剂流体接触,并且将该液体制剂暴露在光源下以激活光敏引发剂,从而引起液体制剂中至少一种聚合物体系的聚合作用。
实施方案可包括下面特征中的一个或多个。至少一种聚合物体系的聚合作用导致部分地嵌在织物的第二层中的屏障层的形成。第一聚合物体系包括碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素,第二聚合物体系包括用丙烯酸酯封端的聚乙二醇-碳酸亚丙酯/乳酸酯多嵌段聚合物。光敏引发剂包括曙红Y。所述液体制剂进一步包括促进剂和至少一种缓冲剂。在一些实施方案中,所述液体制剂包括促进剂,例如N-乙烯基己内酰胺,和两种缓冲剂,如三乙醇胺和磷酸钾。
实施方案还可包括下面特征中的一个或多个。用于激活光敏引发剂的光源是具有大约1到大约100mW/cm2强度的LED阵列。所形成的外科假体在对流烘箱中进行干燥。
通常,在另一方面,本发明公开了修补在围绕患者体腔的壁上的开口的方法。该方法包括提供外科假体,例如上面所描述的外科假体,并且将该外科假体固定在患者的壁开口上,使得粘连屏障面对要防止粘连到其上面的内脏或组织。
实施方案可具有下面优势中的一个或多个。所述外科假体可用于治疗患者体腔中的开口而产生最小的粘连或无粘连形成。由于粘连屏障结合在丝网内,在亲水的粘连屏障和疏水的聚丙烯丝网之间存在强机械连接作用。结果,减少了粘连屏障从丝网上剥离的可能。所述外科假体的另一优势是包含形成丝网的两层的相互环扣或相互缠绕的纱线。使用相互环扣或相互缠绕的纱线降低甚至消除了在形成外科假体时对粘合剂的依赖。
在这里使用的“非生物降解”意味着包含这样组分的物质,该组分当存在于体腔中时,不易被降解、吸性或者另外地分解。
在这里使用的“生物降解”意味着包含这样组分的物质,该组分在外科假体植入之后一段时间内,如在植入之后几周或几个月内可被降解和/或吸收。
在这里使用的“基本上”意味着所说明的是主要地但非完全地。当一层被说成基本上是非生物降解时,它是指主要由非生物降解材料组成的层,但是该层的很小的体积内非生物降解材料与生物降解材料相互缠绕。当一层被说成基本上是生物降解时,它是指主要由生物降解材料组成的层,但该层的很小的体积内生物降解材料与非生物降解材料相互缠绕。
在伴随的附图和下面的描述中说明了本发明的一个或多个实施方案的细节。从说明书和附图中以及从权利要求书中将明白本发明的其他特征和优点。
附图说明
图1A是外科假体一个实施方案的截面图。
图1B是图1A的外科假体第一表面的表面图。
图1C是图1A的外科假体第二表面的表面图。
图2A是用于构成外科假体的丝网的截面图。
图2B是图2A的丝网的非生物降解层的表面图。
图2C是图2A的丝网的生物降解层的表面图。
图3A是用于构成外科假体的丝网的另一实施方案的表面图。
图3B是图3A的丝网的截面图。
图4是修补之前体腔壁上开口的表面图。
图5是用图1A中所示的外科假体正确定位修补的图4所示的开口的表面图。
图6是图5中开口和外科假体的表面图,现在通过缝合将该开口闭合。
各个附图中相同的参考符号指代相同的元件。
详细描述
参看图1A-C,用于修补体腔内多余开口如腹部开口的外科假体10包括由三维丝网30所支撑的粘连屏障20。在图1A-C中显示了具有粘连屏障20的三维丝网30而图2A-C中显示了不具有粘连屏障20的三维丝网30,该丝网30由界定了至少两层(在此为两层)的生物降解性纱线32和非生物降解性纱线34所构成。特别参考图1B,所述至少两层中的一层即层33构成第一丝网表面35且基本上是非生物降解的。特别参考图1C,所述至少两层中的另一层即层37构成第二丝网表面39且基本上是生物降解的。层33和37由生物降解的结合纱线40连接在一起。粘连屏障20基本上防止在外科假体上形成粘连,其直接在生物降解层37上形成(例如:在其上聚合),因此使粘连屏障20与丝网30互相连接。
在将粘连屏障20施加到丝网30上以形成外科假体10之前,丝网30具有界于大约2.5和3.0毫米之间的未压缩的厚度,大约13到16g/ft2的面密度,并且包括可从第一丝网表面35和第二丝网表面39进入的大孔结构(例如,具有大约100微米或更大的孔尺寸)。在将粘连屏障20施加到丝网30上并进行空气干燥后,外科假体10具有界于大约0.45和0.9毫米之间的厚度,大约18到21g/ft2的面密度,并包括仅可从第一丝网表面35进入的大孔结构。就是说,粘连屏障20被施加到丝网30上,使得粘连屏障20延伸过第二丝网表面39并进入到丝网30的生物降解层37的大孔结构中,因此至少部分地填充了层37的大孔结构。在一些实施方案中,层37的大孔结构可用一小孔结构(例如,具有大约50微米或更小的孔尺寸,优选具有10微米或更小的孔尺寸)代替。
丝网
丝网30是包括生物降解性纱线32和非生物降解性纱线34的任何编织或针织结构。典型地,丝网中非生物降解性纱线与生物降解性纱线的比率在大约0.1到9的范围内。在某些实施方案中,非生物降解性纱线与生物降解性纱线的比率是1至2.33。丝网30具有在其一侧允许粘连屏障20缠绕和交错在生物降解层37内的结构,而在其相对侧具有为细胞的向内生长和修补提供强支持框架的结构。在一些实施方案中,例如图2A-C中所阐明的实施方案,丝网30包括已经相互缠绕和/或相互环扣以界定层33和37的生物降解和非生物降解性纱线。在某个实施方案中,例如图3A-B中所示的实施方案,丝网30’包括由非生物降解性纱线34构成的预制非生物降解丝网33’和由生物降解性纱线32构成的预制生物降解丝网37’,它们用生物降解的结合纱线40缝合在一起。
通常,丝网30中的非生物降解性纱线34可根据需要来选择。典型地,将非生物降解性纱线34选择为对使用外科假体10的患者具有生物相容性。另外,丝网30中所用的非生物降解性纱线34典型地具有介于大约1.0和2.0lbs之间的直拉伸强度,基于ASTM标准#D2256-95A的方法测量。在一些实施方案中,非生物降解性纱线34是具有大约0.001英寸到大约0.010英寸直径的单丝纱线。在某些实施方案中,非生物降解性纱线34具有大约0.005英寸的直径。非生物降解性纱线的例子包括聚丙烯和聚对苯二甲酸乙二醇酯。
丝网30中的生物降解性纱线32、40也可根据需要来选择。通常,将生物降解性纱线选择为与粘连屏障20相容。在一些实施方案中,该生物降解性纱线是亲水的。在某些实施方案中,丝网30中所用的生物降解性纱线32具有介于大约0.4和1.8lbs之间的直拉伸强度,基于ASTM标准#D2256-95A的方法测量。在一些实施方案中,生物降解性纱线是90丹尼尔或更小的复丝纱线。该复丝纱线可包括每个具有大约0.0006英寸厚度的10到50个单丝纤维。生物降解性纱线的例子包括聚乙醇酸(PGA)、聚乳酸(PLA)、聚二氧杂环己酮(PDO)、聚己内酯(PCL)、藻酸钙和其共聚物。
在一些实施方案中,非生物降解和/或生物降解性纱线可用滑润剂涂覆以有利于纱线的针织。用于非生物降解和生物降解性纱线的滑润剂的适当例子包括无毒的疏水蜡,例如脂肪酸醇的酯,或者亲水润滑剂,例如聚烷基二醇。一种对非生物降解性纱线产生特别好结果的特定纺丝助剂是Lurol PP-3772(Goulston Technologies,Inc.,Monroe,NC)。泊洛沙姆184、聚山梨醇酯20、月桂基硫酸钠、丙二醇甲醚和甲苯的纺丝助剂混合物对生物降解性纱线产生好的结果。
粘连屏障
粘连屏障20组合物可包含由生物再吸收材料制成的凝胶、泡沫体、薄膜或膜层。粘连屏障20可从选自透明质酸和其任何盐、羧甲基纤维素和其组合盐、氧化的再生纤维素、胶原、明胶、磷脂和下面所描述的第一和第二聚合物体系以及任何它们的交联或衍生形式中的一种或多种组合来制备。在一些实施方案中,屏障物由当接触到水性流体如盐水、磷酸盐缓冲液或者体液时能够形成水凝胶的材料制成。
在一个优选的实施方案中,粘连屏障2组合物包含至少两种聚合物体系的混合物。第一聚合物体系包括具有三维聚合物网络的、交联、可生物降解的多嵌段聚合物水凝胶。第二聚合物体系包含至少一种通过与碳二亚胺化合物反应来改性的聚阴离子多糖。
第一聚合物体系的交联的聚合物水凝胶包含在大分子单体的聚合过程中所形成的亲水嵌段、生物降解嵌段和交联嵌段。大分子单体是包含至少一个亲水嵌段、至少一个生物降解嵌段和至少一个可聚合基团的大分子。这些嵌段中的一个或多个在本质上可能是聚合物。至少一个生物降解嵌段包含基于碳酸酯或酯基的键,并且除了碳酸酯或酯基,大分子单体可含有其他可生物降解的键或基团。用于形成聚合物水凝胶的适当的大分子单体和制备它们的方法已经公开在美国专利No.6,083,524和美国专利No.5,410,016,其公开的内容通过引用结合于此。
适当的亲水聚合物嵌段包括在结合到大分子单体之前是水溶性的那些,如聚乙二醇、聚环氧乙烷、部分或完全水解的聚乙烯醇、聚乙烯基吡咯烷酮、聚(乙基噁唑啉)、环氧乙烷和环氧丙烷的嵌段共聚物(泊洛沙姆和meroxapols)、poloxamines、羧甲基纤维素、诸如羟乙基纤维素和甲基羟丙基纤维素之类的羟烷基化的纤维素、多肽、多核苷酸、诸如Ficoll聚蔗糖的多糖或碳水化合物、透明质酸、葡聚糖、硫酸肝素、硫酸软骨素、肝素或藻酸盐,和诸如明胶、胶原蛋白、白蛋白或卵白蛋白的蛋白质。优选的亲水聚合物嵌段源自聚乙二醇和聚环氧乙烷。
生物降解嵌段优选在体内条件下能够水解。生物降解嵌段可包括羟基酸的聚合物和低聚物、碳酸酯或其他产生无毒的或在体内作为正常代谢产物存在的物质的生物可降解聚合物。羟基酸优选的低聚物或聚合物是聚乙醇酸(也称为聚乙醇酸酯)、聚(DL-乳酸)和聚(L-乳酸)(也称为聚乳酸酯)。其他有用的物质包括聚(氨基酸)、聚(酐)、聚(原酸酯)和聚(磷酸酯)。聚内酯,如聚(ε-己内酯)、聚(δ-戊内酯)、聚(γ-丁内酯)和聚(β-羟基丁酸酯)也是有用的。优选的碳酸酯源自环状碳酸酯,其可与羟基结尾的聚合物反应而不释放水。适当的碳酸酯源自碳酸亚乙酯(1,3-二氧戊环-2-酮)、碳酸亚丙酯(4-甲基-1,3-二氧戊环-2-酮)、碳酸1,3-亚丙酯(1,3-二噁烷-2-酮)和碳酸亚丁酯(1,3-二氧杂环庚烷-2-酮)。
可聚合基团是能形成附加共价键导致大分子单体相互连结的活性官能团。可聚合基团具体地包括经自由基聚合能够聚合的基团以及经阳离子或异裂聚合能够聚合的基团。适当的基团包括但不限于烯属或炔属不饱和基团、异氰酸酯、环氧化物(环氧乙烷类)、巯基化物、琥珀酰亚胺类、马来酰亚胺类、胺、亚胺、酰胺、羧酸、磺酸和磷酸盐基团。烯属不饱和基团包括乙烯基团,如乙烯基醚、N-乙烯基酰胺、烯丙基、不饱和一元羧酸或它们的酯或酰胺,不饱和二元羧酸或它们的酯或酰胺,以及不饱和三元羧酸或它们的酯或酰胺。不饱和一元羧酸包括丙烯酸、甲基丙烯酸和巴豆酸或它们的酯或酰胺。不饱和二元羧酸包括顺丁烯二酸、反丁烯二酸、衣康酸、中康酸或柠康酸或它们的酯或酰胺。不饱和三元羧酸包括丙烯三甲酸或它们的酯或酰胺。可聚合基团还可以是这样的物质,如丙烯酰胺、N-异丙基丙烯酰胺、丙烯酸羟乙酯、甲基丙烯酸羟乙酯和类似的乙烯基及烯丙基化合物的衍生物。
可聚合基团优选位于大分子单体的一个或多个末端。或者,可聚合基团可以位于大分子单体内。至少一部分大分子单体每个分子可含有一个以上的活性基团,使得所形成的亲水聚合物可以被交联以形成凝胶。在本文中将每个分子具有两个或更多个可聚合基团的大分子单体称为交联剂。所需交联剂的最小比例将根据要形成的水凝胶的希望的性能和溶液中初始大分子单体的浓度而变动。大分子单体溶液中交联剂的比例可以高达溶液中所有大分子单体的大约100%。例如,大分子单体包括平均至少1.02个可聚合基团,并且更优选地,大分子单体备包括平均两个或更多个可聚合基团。Poloxamines是适于形成亲水嵌段的水溶性聚合物组分的一个例子,具有四个臂,因此可以被容易地改性以包括四个可聚合基团。
下面阐述优选的大分子单体的例子:
其中聚乙二醇重复单元是-(CH2-CH2-O)X-或(PEG)X,碳酸亚丙酯重复单元是-(C(O)-O-(CH2)3-O)W-或(TMC)w;乳酸残基是-(O-CH(CH3)-CO)y-或(L)y;丙烯酸酯残基是CH2=CH-CO-或A,并且q,w,w’,y,y’和x是整数。
A-(L)y-(TMC)W-[(PEG)X-(TMC)W’]q-(L)y’-A
A-(L)y-[(PEG)X-(TMC)W’]q-(L)y’-A
A-[(PEG)X-(TMC)W’]q-(L)y’-A]
大分子单体的聚合可通过光化学手段,通过象氧化还原作用(Fenton化学)的非光化学手段或通过热引发(过氧化物等)来引发。适当的光化学手段包括在光引发剂如UV或光线敏感的化合物如染料,优选曙红Y存在下将大分子单体溶液暴露在可见光或UV光线下。
大分子单体的聚合可在少量用作聚合反应促进剂的单体存在下进行。优选该单体占可聚合物质总含量的2%或更少,更优选占1%或更少,并且通常大约为4,000ppm。优选的促进剂是乙烯基己内酰胺。
在下面的讨论和实施例中,大分子单体可用xxkZnAm形式的编码标明,其中xxk表示骨架聚合物的以道尔顿为单位的分子量,所述骨架聚合物是聚乙二醇(“PEG”),除非另有说明,x代表一数字而k代表千的乘数;Z指明生物降解嵌段源自其的分子单元,并且可取L,G,D,C或T的一个或多个值,其中L用于表示乳酸,G用于表示乙醇酸,D用于表示二氧杂环己酮,C用于表示己内酯,T用于表示碳酸亚丙酯;n是无规分布在骨架聚合物每一端上的可降解基团的平均数;A用于表示丙烯酸酯而m为每个大分子单体分子的可聚合基团的数目。这样,如实施例部分中所用的20kTLA2是具有20×103Da聚乙二醇核的大分子单体,平均具有在乙二醇核的两端顺续延伸并在两端之间无规分布的碳酸亚丙酯残基(每个大分子单体有7或更多个,平均大约为12个残基)和乳酸残基(每个大分子单体有5或更少个残基),接着终结于2个丙烯酸酯基团。
第二聚合物体系包含至少一种由碳二亚胺改性的聚阴离子多糖。这些被改性的聚合物的制备方法已经描述在美国专利No.5,017,229和美国专利No.5,527,983中,其全部公开内容通过引用结合于此。
适当的聚阴离子多糖可选自以下物质中的一种或多种:透明质酸、羧甲基纤维素、羧甲基直链淀粉、羧甲基脱乙酰壳多糖、硫酸软骨素、硫酸皮肤素、肝素、硫酸肝素、藻酸和它们的任何盐,包括钠、钾、镁、钙、铵或其混合物。
通过与碳二亚胺反应改性聚阴离子多糖以构成N-酰基尿素衍生物并使它们不溶于水,然而,它们保留很强的亲水性,这样吸收水分以构成凝胶,其也被称为水凝胶。与碳二亚胺进行的反应条件在上述所引用的专利中进行了很好的描述。优选的碳二亚胺是那些展现出水溶性的,诸如1-(3-二甲氨基丙基)-3-乙基碳二亚胺(EDC)或者1-乙基-3-(3-二甲氨基丙基)-碳二亚胺甲碘化物(ETC)。
在与碳二亚胺反应后,所改性的聚阴离子多糖组分可以被干燥到少于约20%的湿含量,优选为大约9%并且以粉末的形式存储。
为了制备屏障组分,所改性的聚阴离子多糖合成物可单独在缓冲液中进行再水化以便在与第二聚合物体系的大分子单体溶液混合之前构成流体凝胶。屏障组合物还可通过在第二聚合物体系的大分子单体溶液的缓冲液中再水化经过改性的聚阴离子多糖组分来制备,从而构成包含两种聚合物体系的流体凝胶。接着将该流体凝胶浇注到具有所要形状的盘子中并暴露在聚合的条件下,诸如UV或可见光以构成本发明的屏障组合物。一旦流体凝胶中的大分子单体已经发生聚合,则屏障组合物形成已经改进了操作属性且能抵抗撕扯的含水的软橡胶状物质。通过选择合适的模子或通过挤出可将该屏障组合物聚合到象板状、盘状、管状或杆状的所需形状的物品。
为了包装可将该屏障组合物进一步干燥,接着在植入到患者(诸如人体或诸如非人类哺乳动物的动物)的身体之前进行再水化。优选地将该屏障组合物或成型的物品在对流炉中干燥至少于大约5%的湿含量,并且优选地少于大约2%以构成薄膜或膜层,或者在真空下冷冻干燥以构成泡沫体。可单独使用该屏障组合物来治疗或防止手术并发症(例如,防止粘连的形成)。
以流体的形式还可将该屏障组合物沉积在诸如织物(例如编织或无纺织物,诸如丝网、针织物、起绒织物和不光滑织物)的医疗装置的表面并且接着用任何已知的方法来干燥。在其中屏障组合物处于薄膜或泡沫体形式的实施方案中,该屏障组合物可通过任何已知的方法层压和/或缝合到织物上。在其中屏障组合物由包括大分子单体(例如,流体凝胶)的溶液所构成的实施方案中,通过将织物放置在流体凝胶中并开始聚合作用可将屏障组合物沉积到织物上。疏水织物将漂浮在流体凝胶的表面。不太疏水的织物,诸如具有极性基(例如酯、酰胺、酮和碳酸盐)的织物在一定程度上可穿透该表面进入流体凝胶使得织物存在下的大分子单体上官能团的聚合作用给织物提供更大的屏障组合物粘连。在本发明的复合多层织物中,其中一层比另一层具有更小的疏水性,当将织物更小疏水性的一侧放置在流体凝胶上时,在织物该侧上的纤维刺入流体凝胶中,而织物另一侧上的疏水纤维漂浮在流体凝胶上。一旦组合物进行聚合,聚合物网络的一部分俘获织物的更小疏水性纤维,在织物上提供增强的屏障粘连强度。
一旦应用到该装置或织物上,可对屏障组合物进行干燥用于长期存储和包装,接着在移植到患者身体内之前进行再水化。
通常,粘连屏障可处于薄膜、泡沫体或凝胶的形式。在一些实施方案中,该粘连屏障具有小于每平方英尺大约20克总聚合物的密度。在一些实施方案中,该粘连屏障具有每平方英尺大约4克到大约6克总聚合物的密度。在某些实施方案中,该粘连屏障具有每平方英尺大约5克总聚合物的密度。
参考图4-6,外科假体10可用于修补暴露脏器面122(例如,肠、网膜)的患者体腔120的壁110上的开口100。为了修补开口100,医学专业人员将外科假体10穿过开口100插入到体腔120中。定位外科假体10使得层37面向脏器面122而层33面向壁110并覆盖开口100。一旦定位外科假体10,医学专业人员用缝线130缝合开口100。
随着时间的推移,丝网30的粘连屏障20(例如,大约3到28天)和层37(例如,大约60到90天)被身体吸收,留下层33与脏器面122接触。然而,到粘连屏障20已经被吸收时,开口100已经愈合到在脏器与外科假体10之间形成粘连的几率达很小的程度(例如,新的腹膜面已经在开口100上形成)。另外,层37,其由生物降解性纱线32构成,提供第二防御防止粘连发生。如上所述,层37经大约60到90天的期间被身体吸收。结果,当层37被吸收时,将解除由于粘连屏障20故障或者粘连屏障20被吸收后而形成的任何粘连。
当粘连屏障20和层37都被患者的身体所吸收的时候,外科假体10的层33变成结合到壁110中。基本上由非生物降解性纱线34做成的层33提供强健的大孔结构,允许组织向内生长(例如,层33具有100微米或者更大的孔尺寸)以修补开口100。
通常,利用任何所需的方法可制备外科假体10。在某些实施例中,外科假体10制备如下。第一,利用生物降解性纱线32和非生物降解性纱线34产生三维丝网30。将该纱线32、34穿引到工业针织机器上,诸如双针床针织机。利用任何针织式样将纱线32和34针织在一起产生具有生物降解层(例如,层37)和非生物降解层(例如,层33)的三维大孔结构。在某些实施例中,通过将非生物降解性纱线、第一生物降解性纱线和第二生物降解性纱线针织在一起构成丝网30,其中非生物降解性纱线和第一生物降解性纱线分别构成层33和37而第二生物降解性纱线将层33和37结合在一起。为了将粘连屏障20应用到丝网30上,将包括光敏引发剂和粘连屏障前体组分的液体制剂加入到玻璃托盘中。接着以生物吸收侧(层37)面向托盘底部的方式(例如生物吸收层与液体制剂液体接触)将丝网30放入托盘中。通过将托盘暴露在激活光敏引发剂的光源(例如,具有波长大约450nm到大约550nm且强度大约1mW/cm2到大约100mW/cm2的光源)中来光化聚合液体制剂。作为光引发的结果,在托盘内围绕至少一部分层37构成水凝胶。接着干燥该水凝胶使得所得的丝网/水凝胶具有小于大约2%(例如,小于大约1.2%,诸如大约0.8%)的湿含量。接着对该丝网/干燥的水凝胶进行消毒以构成外科假体10。
人们相信由于至少三个原因在光化聚合作用期间层33的多孔结构内没有形成水凝胶。第一,控制加到玻璃托盘中的液体制剂的量以产生厚度等于或者小于层37厚度的水凝胶。例如,在托盘的每平方英寸中加入包括光敏引发剂和粘连屏障前体组分的近似一毫升的溶液。接着,将带具有大约2.5毫米未压缩厚度的生物降解层的14.5g/ft2面密度的丝网加入到托盘中。第二,由于在非生物降解性纱线34(例如,疏水的)和亲水前体组分之间存在不相容性,因此液体制剂倾向于不通过毛细作用进入层33的孔结构中。结果,当液体制剂进行聚合时,它仅在层37的周围构成水凝胶。第三,当聚合的水凝胶(其主要是水)进行气体干燥时,它在厚度上大幅地减少。结果,粘连屏障仅在层37的周围。
下面的实施例是说明性的并非意旨限定性的。
实施例1
为了制造三维丝网,将两个5密耳聚丙烯单丝纤维(ShakespeareMonofilament and Specialty Polymers,Columbia,SC)、一个45丹尼尔聚乙醇酸复丝纤维(Teleflex Medical,Coventry,CT)和一个90丹尼尔聚乙醇酸复丝纤维(Teleflex Medical,Coventry,CT)穿引到双针针织机床上(Karl Mayer Text imaschinenfabrikGmbH,Oberlshausen,Germany)。参考图2A-C,利用下面所给的条状图形通过Secant Medical,Perkasie,PA共同针织该纤维以产生丝网,该丝网具有在前面基本上由聚(乙醇)酸构成的层(图2C)、在后面基本上由聚丙烯构成的层(图2B)以及将两层连接起来的聚乙醇酸结合纤维(图2A)。
表1:丝网条状图形
条 | 纤维 | 方式 |
1 | 完全穿引的5密耳聚丙烯单丝纤维 | 1/0,1/2,2/3,2/1 |
2 | 完全穿引的5密耳聚丙烯单丝纤 | 2/3,2/1,1/0,1/2 |
3 | 半设定穿引的45丹尼尔聚乙醇酸复丝纤维 | 1/0,1/2 |
4 | 半设定穿引的90丹尼尔聚乙醇酸复丝纤维 | 1/0,2/3 |
在制作之后,将三维丝网在洗涤系统中清洗并在150℃下于热设定框架中退火以稳定三维丝网结构。所得到的三维丝网具有平均每英寸18个条纹,每英寸28层(course),0.0319英寸的厚度,每平方码4.60盎司的面密度,利用基于ASTM标准#D3787-89的方法测定的762±77牛顿的爆裂力度,利用基于ASTM标准#D5587-96的方法测定的在平行于机械方向上的127±21牛顿和垂直于机械方向上203±15牛顿的撕裂传播强度、在距丝网边缘五毫米利用20计量针的拉力所测定的在平行于机械方向上的60±12牛顿和垂直于机械方向上的80±9的缝合保持力度。
实施例2
包括粘连屏障20的前体的液体制剂制作如下。首先如美国专利No.5,017,229和5,527,893中所描述的制备1克经改性和照射的透明质酸/羧甲基纤维素(HA/CMC)粉末,在高剪切力下将其与86克去离子水混合以构成悬浮液。接着,将2.5克基于用丙烯酸酯(20kTLA2)和美国专利No.6,177,095中的描述进行封端的聚乙二醇-碳酸亚丙酯/乳酸酯多嵌段聚合物的光聚合化合物粉末混合到该悬浮液中。接着,将40ppm的曙红Y,光敏引发剂,4000ppm的N-乙烯基己内酰胺,促进剂,0.54克的三乙醇胺,缓冲剂和电子转移组分,以及0.8克的磷酸钾,第二缓冲剂,混合到该悬浮液中,为了完成该液体制剂,加入附加的去离子水以使最终体积达100克。
实施例3
将实施例1中所述的丝网与实施例2中所述的粘连屏障结合起来以构成具有一个表面用于组织的向内生长和一个表面带抗粘连性的用于软组织修补的外科假体。
为了将粘连屏障连接到丝网上,将实施例2中所描述的液体制剂在每平方英尺5克总聚合物的浇注密度下浇注到玻璃盘上。以聚乙醇酸层面向玻璃盘的方式将丝网放置在液体制剂中。在大约4mW/cm2的强度下用来自LED阵列的可见光(450-550nm)照射该区域120秒。将该光聚合组分在对流炉中50℃下干燥4小时。将干燥的组分从玻璃盘中剥落,切割成各种尺寸、包装并用环氧乙烷消毒。
实施例4
将实施例3中制备的外科假体在具有擦伤肠道的兔子疝气修补模型中进行评估。
20只性成熟的雌性新西兰白兔每只在手术时重量在3kg到5kg之间,将其麻醉并使其受到5cm乘7cm完全厚度的腹部肌肉切除和盲肠擦伤手术处理。每只兔子接受5cm乘7cm聚丙烯丝网或者实施例3中所制备的外科假体。使所有兔子都能够从该手术处理中痊愈。
手术后的28天,对这些兔子实施安乐死并评估物质的全部性能,包括粘连的形成和组织的向内生长。评估粘连形成并对由粘连造成的区域覆盖进行视觉打分。在视觉检查期间使用下面的指标:0=没有粘连,1=25%或更少的由粘连覆盖的缺损,2=26%到50%的由粘连覆盖的缺损,3=51%到75%的由粘连覆盖的缺损,4=大于75%的由粘连覆盖的缺损。
除了视觉检查,使用图形分析来计算缺损的总表面区域和由粘连覆盖的表面区域。也进行了收集和分析机械测试和SEM采样。该结果描述在下面的表2和3中。
表2:具有擦伤肠道的兔子疝气修补粘连降低功效的结果
组N=10 | 粘连的平均程度 | 具有粘连的缺损% | 不带粘连的动物% | 不带致密的肠粘连% |
聚丙烯丝网 | 2.9±0.3 | 47.3±6.3 | 0 | 0 |
如实施例3中所制备的外科假体 | 1.3±0.2* | 14.3±5.0* | 0 | 60** |
*p<0.05Tukey Kramer HSD分析
**p<0.05Chi-Square分析
表3:具有擦伤肠道的兔子疝气修补组织结合结果
组 | 最大负载(N)±SEM |
聚丙烯丝网 | 33.7±1.2 |
如实施例3中所制备的外科假体 | 29.7±1.3 |
^P<0.05Tukey Kramer HSD分析
表2中的结果指出了实施例3中所描述的外科假体在防止体内致密肠粘连中表现非常好。另外,实施例3中所描述的外科假体具有如表3中所示杰出的组织结合力度。
实施例5
通过将实施例1中所描述丝网的生物吸收性聚乙醇酸一侧放置到具有56.7平方厘米面积的聚苯乙烯碟子中的10到12ml液体制剂内来制备外科假体。对于液体制剂,在90克水中的2克碳二亚胺改性的HA/CMC粉末与100克去离子水中的5%的20kTLA2大分子单体混合。加入由去离子水中的40ppm的曙红Y、4000ppm的N-乙烯基己内酰胺、1.08克的三乙醇胺和1.6克的磷酸钾所组成的另外的溶液使最终体积达到200克。
接着在大约4mW/cm2的强度下用LED阵列(450-550nm)经过45秒将液体制剂光聚合成水凝胶。在从聚苯乙烯碟子剥离之前,将具有水凝胶的丝网在接近-30℃和200毫乇下进行冷冻干燥。所得到的外科假体在蒸汽渗透袋内的特氟纶涂层板与双包装之间在5,000lbs力下压缩10秒。使用前通过将该外科假体暴露在环氧乙烷中进行消毒。
利用实施例4中所述的处理,将该实施例中所述的5cm乘7cm的聚丙烯丝网或者外科假体植入到具有擦伤肠道的兔子疝气修补模型的10只兔子中达14天和10只不同的兔子中达28天。结果显示在下面表4中。
表4:具有擦伤肠道的兔子疝气修补粘连降低功效的结果
组:14天 | 粘连的平均程度 | 具有粘连的缺损% | 不带粘连的动物% | 不带致密的肠粘连% |
聚丙烯丝网 | 3.0±0.6 | 65±11 | 0 | 0 |
如实施例5中所制备的外科假体 | 1.0±0.3* | 16±8* | 20 | 40 |
组:28天 | 粘连的平均程度 | 具有粘连的缺损% | 不带粘连的动物% | 不带致密的肠粘连% |
聚丙烯丝网 | 2.4±0.3 | 42±13 | 0 | 0 |
如实施例5中所制备的外科假体 | 1.0±0.1* | 12±3* | 10 | 20 |
*p<0.05Tukey Kramer HSD分析
粘连降低功效的结果显示了该实施例中所述的外科假体在防止体内的粘连中表现很好。
实施例6
制备2.5%20kTLA2、40ppm曙红Y、4000ppmN-乙烯基己内酰胺、0.54%三乙醇胺、0.8%磷酸钾和1%碳二亚胺改性的HA/CMc的液体制剂并将32ml的该液体制剂浇注到32平方英寸的玻璃盘中。以生物降解性聚乙醇酸一侧向下将实施例1中的丝网放置到液体制剂中。通过将液体制剂暴露在具有大约4mW/cm2强度的发射可见光的二极管阵列四分钟使该液体制剂进行光聚合。在将玻璃盘去除之前,让所得的用水凝胶加固的丝网在50℃下风干四小时。接着将被加固的丝网在100℃下脱水七小时以构成外科假体。
实施例7
测试实施例6的外科假体的手术操作性。使用成年家猪的盆腹腔来模拟该外科假体的腹腔镜临床应用。
将外科假体插入到成年家猪盆腹腔中的外科大夫能够区分湿的修正一侧和干燥的外科假体。在插入之前,外科大夫在外科假体的每一端系上留置缝线。接着在通过12毫米的套管针将修复物传送之前,外科大夫将外科假体在盐水中进行水合几秒钟。将一部分留置缝线穿过腹壁并进行固定。利用螺旋钛钉将该外科假体钉在侧壁上。在放置期间该外科假体的适度操作不会引起分层。大体说来,外科大夫对外科假体的操作、放置和耐久性是满意的。
实施例8
通过将具有大约7mg/cm2质量/面积与大约1毫米厚度的聚乙醇酸(PGA)无纺毡合织物与具有9.4mg/cm2质量/面积并且由6密耳的聚丙烯纤维制成的(经编)单梳栉经缎针织聚丙烯丝网缝合在一起构成用于外科假体的丝网。PGA无纺毡合织物从Scaffix International(Dover,MA)处获得并且(经编)单梳栉经缎针织聚丙烯丝网从GenzymeBiosurgery(Fall River,MA)处获得。
利用标准缝纫机中的尺寸是6-0的Bondek聚乙醇酸缝线(由Genzyme Biosurgery,Coventry,CT,现为Teleflex Medical,Coventry,CT提供)将无纺毡合织物缝合到聚丙烯丝网上。当缝合在一起时丝网的质量/面积为16到17mg/cm2。
为了构成外科假体,PGA无纺毡合一侧向下将丝网放置在具有56.7cm2面积的聚苯乙烯碟内的20kTLA2、40ppm曙红Y、4000ppmN-乙烯基己内酰胺、0.54%三乙醇胺、0.8%磷酸钾的10ml、2.5%的液体制剂中。用来自氙光源的五个40秒循环将该液体制剂光聚合成水凝胶。具有水凝胶的丝网在-30℃和200毫乇下进行冷冻干燥。得到了一个结合很好的、弹性干燥样品。通过暴露在环氧乙烷中对外科假体进行消毒。在初始水合之后,该外科假体具有良好的湿操作耐久性。
实施例9
利用实施例8中所述的处理构成用于外科假体的丝网。将无纺毡合织物侧向下放置在具有12克悬浮液的56.7cm2聚苯乙烯碟中,该悬浮液包括从Genzyme公司(Framingham,MA)获得的2.3%的碳二亚胺改性的HA/CMC和0.073ml的丙三醇,增塑剂。包括悬浮液和丝网的碟子放置一夜风干。
得到了高质量复合样品,所有组分稳固连接,具有21.7mg/cm2的质量/面积比率。利用扫描电子显微镜(SEM),观察到增塑的HA/CMC膜层嵌入在丝网的无纺毡合织物一侧的纤维中。一些空隙在粘连屏障内是很明显的,这可能归因于气泡。
在对流炉中将样品在100℃加热达7个小时以去除残留的水分。一进行水合作用,HA/CMC的亲水、光滑层在外科假体的一个表面上在视觉上是很明显的。在初始水合之后以及在室温下浸泡在水中24小时之后,该外科假体具有良好的湿操作性。含水的样品在拇指和食指之间可进行强有力的摩擦而不会分层并且用手不能将其剥离。
实施例10
利用实施例8中所述的处理构成用于外科假体的丝网。将无纺毡合织物侧向下放置在具有由20kTLA2、40ppm曙红Y、4000ppmN-乙烯基己内酰胺、0.54%三乙醇胺、0.8%磷酸钾和5%透明质酸组成的5ml、5%溶液的56.7cm2聚苯乙烯碟子中。接着用来自从GenzymeBiosurgery(Lexington,MA)获得的氙光源的四个40秒循环将该溶液光聚合成水凝胶。
该外科假体具有良好的湿操作耐久性并可直接使用或冷冻干燥以便以后使用。
实施例11
通过将polyglactin 910一种从Ethicon(New Brunswick,NJ)获得的聚乙醇酸和聚乳酸纤维的共聚物构成的Vicryl针织丝网,缝合到由6密耳的聚丙烯纤维制成且能从Genzyme Biosurgery(Fall River,MA)处获得的具有9.4mg/cm2质量面积的(经编)单梳栉经缎针织聚丙烯丝网上以构成用于外科假体的丝网。
利用标准缝纫机中的尺寸6-0的Bondek聚乙醇酸缝线(由GenzymeBiosurgery,Coventry,CT,现为Teleflex Medical,Coventry,CT提供)将Vicryl针织丝网缝合到聚丙烯丝网上。当缝合在一起时丝网的质量/面积为约15mg/cm2。
为了构成外科假体,Vicryl表面向下将丝网放置在具有56.7cm3面积的聚苯乙烯碟内的由20kTLA2、40ppm曙红Y、4000ppmN-乙烯基己内酰胺、0.54%三乙醇胺和0.8%磷酸钾组成的5ml、5%的溶液中。接着用来自氙光源的四个40秒循环将该溶液光聚合成水凝胶。该外科假体在-30℃和200毫乇下进行冷冻干燥。得到了一个结合很好的、弹性干燥的外科假体。在初始水合之后,该外科假体具有良好的湿操作耐久性。
就像明确地、单个指出每个单个出版物或专利作为参考全部结合于此一样,本申请中所涉及的所有出版物、申请和专利作为同样程度的参考结合于此。
在此所公开的所有特征可以任何组合进行结合。所公开的每个特征可用用于同样、等同或近似目的的可选特征进行替代。这样,除非清楚地说明,否则所公开的每个特征仅是等同或近似特征的一般系列的一个实施例。
其他实施方案在下面权利要求的范围内。
Claims (49)
1.外科假体,其包含:
包含至少两种相互环绕或相互缠绕的纱线以界定出至少两层的三维丝网,其中至少两层的其中一层基本上是非生物降解的而至少两层的另一层基本上是生物降解的;并且
与三维丝网的第二、基本上是生物降解的层相互连接的粘连屏障。
2.如权利要求1的外科假体,其中至少两种纱线的其中一种是非生物降解性纱线。
3.如权利要求2的外科假体,其中该非生物降解性纱线选自聚丙烯、聚对苯二甲酸乙二醇酯或其组合。
4.如权利要求2的外科假体,其中该非生物降解性纱线具有0.005英寸的直径。
5.如权利要求1的外科假体,其中至少两种纱线的其中一种是生物降解性纱线。
6.如权利要求5的外科假体,其中该生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或组合。
7.如权利要求5的外科假体,其中该生物降解性纱线具有不大于90丹尼尔的直径。
8.如权利要求1的外科假体,其中三维丝网包括至少一非生物降解性单丝纱线和至少一种生物降解性复丝纱线。
9.如权利要求1的外科假体,其中该粘连屏障包含交联的聚合物水凝胶。
10.如权利要求1的外科假体,其中该粘连屏障包含至少一种通过与碳二亚胺反应而被改性的聚阴离子多糖。
11.如权利要求1的外科假体,其中该粘连屏障包含交联的聚合物水凝胶和至少一种通过与碳二亚胺反应而被改性的聚阴离子多糖。
12.如权利要求11的外科假体,其中交联的聚合物水凝胶包含一种或多种亲水嵌段、一种或多种生物降解性嵌段以及一种或多种交联性嵌段。
13.如权利要求11的外科假体,其中交联的聚合物水凝胶通过包含可光聚合的用丙烯酸酯封端的多嵌段聚合物的单体的光聚合作用形成,所述多嵌段聚合物包括聚乙二醇、碳酸亚丙酯和乳酸酯。
14.如权利要求11的外科假体,其中至少一种通过与碳二亚胺反应来改性的聚阴离子多糖包含碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素。
15.如权利要求1的外科假体,其中粘连屏障处于薄膜或泡沫材料的形式。
16.如权利要求1的外科假体,其中粘连屏障处于凝胶的形式。
17.如权利要求1的外科假体,其中该外科假体具有少于2%的湿含量。
18.如权利要求1的外科假体,其中该外科假体具有少于1.2%的湿含量。
19.如权利要求1的外科假体,其中粘连屏障具有每平方英尺5克总聚合物的密度。
20.外科假体,其包含:
包含至少两种相互环绕或相互缠绕的纱线以界定出至少两层的三维丝网,
基本上由非生物降解性纱线构成的第一层,第一层界定了该外科假体的第一外表面;
基本上由第一生物降解性纱线构成的第二层,第二层用第二生物降解性纱线连接于第一层;和
嵌入第二层内的粘连屏障,该粘连屏障界定了该外科假体的第二外表面;
其中该外科假体的第一外表面具有适于允许组织向内生长进入第一层的大孔结构,该外科假体的第二外表面适于使邻近第二外表面的组织粘连形成减到最小。
21.如权利要求20的外科假体,其中该外科假体的第二外表面是多微孔的。
22.如权利要求20的外科假体,其中大孔结构具有100微米或更大的孔尺寸。
23.如权利要求20的外科假体,其中非生物降解性纱线选自聚丙烯、聚对苯二甲酸乙二醇酯或其组合。
24.如权利要求20的外科假体,其中第一生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或其组合。
25.如权利要求20的外科假体,其中第二生物降解性纱线选自聚乙醇酸、聚乳酸、聚二氧杂环己酮、聚己内酯、藻酸钙或其组合。
26.如权利要求20的外科假体,其中该屏障包含交联的聚合物水凝胶和至少一种通过与碳二亚胺反应来改性的聚阴离子多糖。
27.如权利要求26的外科假体,其中交联的聚合物水凝胶包含一种或多种亲水嵌段、一种或多种生物降解性嵌段以及一种或多种交联性嵌段。
28.如权利要求26的外科假体,其中交联的聚合物水凝胶通过包含可光聚合的用丙烯酸酯封端的多嵌段聚合物的单体的聚合作用形成,所述多嵌段聚合物包括聚乙二醇、碳酸亚丙酯和乳酸酯。
29.如权利要求26的外科假体,其中至少一种通过与碳二亚胺反应来改性的聚阴离子多糖包含碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素。
30.制作权利要求1-29中任一项所述的外科假体的方法,该方法包含步骤:
提供织物,该织物包含基本上由非生物降解性纱线构成的第一层和由生物降解性纱线构成的第二层;
提供包含大分子单体和引发剂的液体制剂;
将该织物放置在液体制剂中使得第二层与该液体制剂流体接触;以及
将该液体制剂暴露于光源从而创造出所述的与三维丝网的第二、基本上是生物降解的层相互连接的粘连屏障。
31.如权利要求30的方法,其中该引发剂是光敏引发剂。
32.如权利要求31的方法,其中该光敏引发剂包含曙红Y。
33.如权利要求30的方法,其中该液体制剂进一步包含生物高分子、促进剂和缓冲剂。
34.如权利要求33的方法,其中该生物高分子包含至少一种通过与碳二亚胺反应而改性的聚阴离子多糖。
35.如权利要求33的方法,其中该缓冲剂包含三乙醇胺。
36.如权利要求33的方法,其中该缓冲剂包含磷酸钾。
37.如权利要求33的方法,其中该促进剂包含N-乙烯基己内酰胺。
38.如权利要求30的方法,其中液体制剂包含1重量百分比的碳二亚胺改性的透明质酸和羧甲基纤维素,2.5重量百分比的用丙烯酸酯封端的多嵌段聚合物,40ppm的曙红Y,4000ppmN-乙烯基己内酰胺,0.54重量百分比的三乙醇胺,0.8重量百分比的磷酸钾,所述多嵌段聚合物包括聚乙二醇、碳酸亚丙酯和乳酸酯。
39.如权利要求30的方法,其中光源是具有1到100mW/cm2强度的LED阵列。
40.制作权利要求1-29中任一项所述的外科假体的方法,该方法包含步骤:
提供织物,该织物包含基本上由非生物降解性纱线构成的第一层和由生物降解性纱线构成的第二层;
提供包含第一聚合物体系、第二聚合物体系和光敏引发剂的液体制剂;
将该织物放置在液体制剂上使得第二层与该液体制剂流体接触;以及
将该液体制剂暴露于光源以激活光敏引发剂从而引起液体制剂中至少一种聚合物体系的聚合作用,从而创造出所述的与三维丝网的第二、基本上是生物降解的层相互连接的粘连屏障。
41.如权利要求40的方法,其中至少一种聚合物体系的聚合作用导致部分嵌入该织物的第二层中的屏障层的形成。
42.如权利要求41的方法,其中第一聚合物体系包含碳二亚胺改性的透明质酸和碳二亚胺改性的羧甲基纤维素,第二聚合物体系包含用丙烯酸酯封端的多嵌段聚合物,所述多嵌段聚合物包括聚乙二醇、碳酸亚丙酯和乳酸酯。
43.如权利要求42的方法,其中该光敏引发剂包含曙红Y。
44.如权利要求43的方法,其中该液体制剂进一步包含促进剂和至少一种缓冲剂。
45.如权利要求44的方法,其中该液体制剂进一步包含第一缓冲剂和第二缓冲剂。
46.如权利要求45的方法,其中促进剂包含N-乙烯基己内酰胺,第一缓冲剂包含三乙醇胺,第二缓冲剂包含磷酸钾。
47.如权利要求40的方法,其中光源是具有1到100mW/cm2强度的LED阵列。
48.如权利要求41的方法,进一步包含步骤:
在对流炉中干燥织物和屏障层。
49.如权利要求1的外科假体,制造所述外科假体是为了通过下述方法修补围绕患者体腔的壁上的开口:
将该外科假体固定在患者的壁开口上使得粘连屏障面对打算防止粘连发生的内脏或组织。
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EP1744796A1 (en) | 2007-01-24 |
AU2005237985A1 (en) | 2005-11-10 |
AU2011200200A1 (en) | 2011-02-10 |
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JP2007533405A (ja) | 2007-11-22 |
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WO2005105172A1 (en) | 2005-11-10 |
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CN101035574A (zh) | 2007-09-12 |
CA2563347A1 (en) | 2005-11-10 |
BRPI0510042A (pt) | 2007-10-16 |
US20130045327A1 (en) | 2013-02-21 |
EP1744796B1 (en) | 2015-03-18 |
CA2563347C (en) | 2014-01-14 |
US8460695B2 (en) | 2013-06-11 |
BRPI0510042B8 (pt) | 2021-06-22 |
AU2005237985B2 (en) | 2010-10-21 |
AU2011200200B2 (en) | 2011-12-22 |
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