CN105662645B - 修复性的有孔编织物 - Google Patents

修复性的有孔编织物 Download PDF

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CN105662645B
CN105662645B CN201510890606.1A CN201510890606A CN105662645B CN 105662645 B CN105662645 B CN 105662645B CN 201510890606 A CN201510890606 A CN 201510890606A CN 105662645 B CN105662645 B CN 105662645B
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braided fabric
hole
prosthetic
sley bar
monofilament
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CN105662645A (zh
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朱莉·勒屈弗雷
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Sofradim Production SAS
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    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/10—Open-work fabrics
    • D04B21/12—Open-work fabrics characterised by thread material
    • 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
    • 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
    • A61F2/0059—Cosmetic or alloplastic implants
    • 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
    • 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
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B1/00—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B1/22—Weft knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes specially adapted for knitting goods of particular configuration
    • 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
    • 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
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/08—Hernia repair mesh

Abstract

本发明公开了一种修复性的有孔编织物。本发明涉及一种基于生物相容的聚合物材料的单丝的修复性的有孔编织物，依照ISO 11676标准，所遵循的用于在具有两个梳栉B1、B2的经编机上编织所述单丝的图案为如下：‑梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//‑梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//本发明进一步涉及一种生产这种编织物的方法并且涉及一种包括这种编织物的疝修复体。

Description

修复性的有孔编织物
技术领域
本发明涉及一种在体壁手术中有用的修复性的有孔编织物，该编织物具有轻量且大孔的结构，同时显现出良好的机械强度特性。
背景技术
壁加强修复体(如用于加强腹壁的修复体)在手术领域中广泛地使用。这些修复体旨在通过临时地或永久地填充组织缺损来治疗疝。这些修复体通常由生物相容的修复性织物制成，尤其是由修复性编织物制成，且这些修复体根据它们要适应的解剖结构可具有多种形状，如矩形、圆形或椭圆形。
为了减少植入到患者体内的异物，期望生产旨在被用作壁加强修复体的轻量编织物。另外，为了有助于外科医生在他将修复体放置在植入部位处的适当位置时的工作，进一步期望的是，修复性的编织物显现出良好的透明性。此外，壁加强修复体还应该促使好的组织向内生长。根据此观点，期望的是，用于壁加强修复体的编织物显现出多个孔，并且优选为大孔。
在壁加强修复体的制造中可用的轻量的有孔编织物已经存在。然而，它们有时显现出差的机械强度。其实，为了一旦被植入就顺应腹壁且与腹壁的运动一起弯曲，编织物通常为柔韧的且柔软的。编织物可通过将编织物缝合、吻合或钉合到周围的生物组织来保持在适当位置。具体地，现存的轻量的有孔编织物在它们缝合或钉合到周围的生物组织时可能显现出差的抗断裂性。
另外，使用固定至腹壁的修复性编织物的腹壁疝修补(abdominal wall herniarepair)的性能部分地取决于在编织物固定点处经受的剪切力。作为高的腹内压的结果，这些剪切力可为非常高的。
一旦编织物或修复体被植入且例如通过缝线而已经被固定在腹壁处，在编织物固定点处的太高的剪切力就可导致腹壁修补再发生和/或造成患者的疼痛。在固定点处的剪切力的分布对估定腹壁修补的安全性和有效性是重要的。
具体地，将期望提供一种由如下编织物制成的修复体：对于该编织物，在固定点处的剪切力的分布尽可能有规律且在固定点处的剪切力的值尽可能低，以便例如，在外科医生不是必须检查编织物的经纱或纬纱方向的具体位置的情况下将修复体导入植入部位处且植入修复体。将进一步期望提供由如下的编织物制成的修复体：对于所述编织物，减小脱离固定的风险和/或减小在固定点处的植入失败的风险。
另外，如果编织物太柔韧和柔软，则在患者的特定运动期间，例如当患者咳嗽或跳跃时，可能不能充分地抵抗腹内压。于是在这种情况下，编织物可能易于出现不期望的鼓起现象，且可能不能确保腹壁的足够加固性。
发明内容
因此存在对于如下的有孔修复编织物的需求：所述有孔修复编织物将能够具有轻量且大孔的结构，同时显现出良好的机械强度特性。
本发明的第一方案是一种基于生物相容的聚合物材料的单丝的修复性有孔编织物，依照ISO 11676标准，所遵循的用于在具有两个梳栉B1、B2的编织机上编织所述单丝的图案(pattern)为如下：
-梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
本发明的另一个方案是一种用于制造上述的修复性编织物的方法，包括依照ISO11676标准，在具有两个梳栉B1、B2的编织机上，依照如下的图案生产具有生物相容的聚合物材料的单丝的编织物的步骤：
-梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
梳栉B1和梳栉B2可以1满1空来穿线且可对称地运动。
编织机可为经编机或拉舍尔针织机。
本发明的编织物为有孔的。具体地，本发明的编织物包括开口或孔：具体地，这些开口或孔通过所遵循的用于编织依照本发明的编织物的单丝的图案来产生。本发明的编织物的孔隙率给予编织物透明性，从而允许外科医生在他将编织物或修复体放入适当位置时具有植入部位的良好可见度。
本发明的编织物为轻量的。本发明的编织物优选地显现出从大约40至大约70g/m2的范围的每单位面积的质量，优选为从大约40至大约50g/m2范围，并且更优选为大约44g/m2、45g/m2、46g/m2、47g/m2或48g/m2，依照ISO3801:1977《每单位长度的质量和每单位面积的质量的测定(Determination of mass per unit length and mass per unit area)》测量，1dm2内5个样本。这种低的每单位面积的质量允许仅仅将很少量的异物导入患者体内。
本发明的编织物由生物相容的聚合物材料的单丝制成。
生物相容的聚合物可为合成的或天然的。生物相容的聚合物可为生物可降解的、非生物可降解的或生物可降解的和非生物可降解的组合。如在此使用的术语“生物可降解的”限定成包含生物可吸收(bioabsorbable)的材料和生物可再吸收(bioresorbable)的材料两者。就生物可降解来说，意指的是，材料分解，或在身体条件下失去结构的整体性(例如，酶促降解或水解)或在身体中的生理条件下(物理地或化学地)分解，以便降解产物能够由身体排出或吸收。
生物相容的聚合物可从由生物可降解的聚合物、非生物可降解的聚合物、以及其合成物构成的群组中选择。
在实施例中，生物相容的聚合物材料从聚丙烯、如聚对苯二甲酸乙二醇酯的聚酯、聚酰胺、硅酮、聚醚醚酮(PEEK)、聚芳基醚酮(PAEK)、聚乳酸(PLA)、聚己酸内酯(PCL)、聚二恶烷酮(PDO)、三亚甲基碳酸酯(TMC)、聚乙烯醇(PVA)、聚羟基脂肪酸酯(PHA)、聚乙醇酸(PGA)、这些材料的共聚物、以及其混合物中来选择。
在实施例中，生物相容的聚合物材料为聚丙烯。
在实施例中，单丝具有从大约0.08mm至大约0.25mm的直径，优选从大约0.10mm至0.15mm，更优选为大约0.11mm、0.12mm或0.13mm。这种直径允许获得孔的良好尺寸且维持编织物的轻量结构，同时维持良好的机械特性。在实施例中，单丝具有大约0.12mm的直径。
在实施例中，编织物包括具有超过1mm的直径的多个孔。具体地，具有超过1mm直径的多个孔限定所述编织物的从大约35％至大约70％范围的、优选为大约55％的有效孔隙率。
就“有效孔隙率”来说，依照本申请，指的是如下的孔隙率：仅仅考虑具有超过1mm直径的孔，而排除具有小于或等于1mm直径的孔。就“具有超过1mm直径的孔”来说，意指在全部方向上具有大于1mm尺寸的孔。因此有效孔隙率相当于如上文限定的具有超过1mm直径的孔的总面积与研究的编织物的总面积之比。具有超过1mm直径的孔用轮廓投影仪(如来自ORAMA的300V投影仪)来测量。“有效孔隙率”和其测量方法描述在生物医学材料研究杂志B辑：应用生物材料(Journal of Biomedical Materials Research Part B：Appliedbiomaterials)，第176-183页，T.Mühl、M.U.Klinge和T.Goedderz的公开文献“描绘纺织品植入件的孔隙率的新的客观测量法(New objective measurements tocharacterize the porosity of textile implants)”中。
如上所述的有效孔隙率对于描绘编织物促进细胞定植的能力是有用的。的确，尤其期望具有超过1mm直径的孔用于在植入后组织向内生长。
本发明的编织物的编织图案限定具有超过1mm范围直径的多个孔。孔可具有大体六角形或圆形形状。
在实施例中，本发明的编织物包括具有超过2mm直径的多个孔。这种带有具有超过2mm直径的孔的编织物促进细胞定植且显示出良好的透明性，允许外科医生在他将编织物/修复体放置在植入部位处的适当位置时，具有周围组织的更好可见度。
在实施例中，本发明的编织物具有至少大约200N、优选大约237N的在经纱方向上的拉伸断裂强度。在实施例中，本发明的编织物具有至少大约170N、优选大约201N的在纬纱方向上的拉伸断裂强度。在实施例中，本发明的编织物具有至少大约400kPa、优选大约463kPa的顶破强度。在实施例中，本发明的编织物具有至少大约25N、优选大约30N的在经纱方向上的撕裂强度。在实施例中，本发明的编织物具有至少大约25N、优选大约37N的在纬纱方向上的撕裂强度。在实施例中，本发明的编织物具有至少大约35N、优选大约46N的在经纱方向上的缝合拔出强度(suture pull out strength)。在实施例中，本发明的编织物具有至少大约38N、优选大约42N的在纬纱方向上的缝合拔出强度。在实施例中，本发明的编织物具有至少大约42N/cm、优选大约47N/cm的拉伸强度。
上文的拉伸断裂强度(N)、顶破强度(kPa)、撕裂强度(N)、缝合拔出强度(N)以及拉伸强度(N/cm)依照如在下面的本申请的实例中所指出的方法来测量。
继编织和热定形后，编织物能够使用传统的已知技术来清洗、包装和消毒。本发明的编织物能够如包装中提供的那样使用或能够在一旦从该包装中取出就切成任意期望的大小。
本发明的编织物能够经由开放的或腹腔镜的方法而被植入在腹膜外部位，用于腹股沟疝或腹壁疝修补。至周围组织的固定能够通过吻合、传统的缝合或其他方式来实现。
本发明的修复性编织物显现出固定点处的剪切力的均匀分布。具体地，尽管设置有轻量结构，但是与现有技术的轻量编织物相比较，本发明的修复性编织物在固定点处显现出良好的抗破裂性。
例如，本发明的编织物可作为待被植入患者内用于疝修补的修复体而独自使用。
本发明的另一个方案是包括如上所述的编织物的疝修复体。
附图说明
本发明从以下描述以及从所附的附图中将会变得更清楚，其中：
图1是本发明的编织物的编织图案的示意图，
图2是通过图1的编织图案获得的本发明的编织物的正视图，
图3是用于测量在编织物的固定点处的剪切力分布的系统的示意构造的侧视图，
图4是图3的系统的一部分的放大的立体图。
图5是在固定点处的剪切力矢量的分布轮廓。
图6是剪切力分布的图形轮廓。
具体实施方式
参考图1，示出表示本发明的编织物的编织图案的图，即依照ISO 11676标准的如下的图案：
-梳栉Bl：1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2：4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
本发明的编织物的总体图案重复尺寸为八个线圈横列(course)。图1仅仅描述了从梳栉B1起的一条丝线以及从梳栉B2起的一条丝线，以更好地示出丝线的运动。丝线在第九线圈横列处的进展与在第一线圈横列处相同。
参考图2，示出了通过如图1所表示的编织图案而获得的本发明的编织物1的照片。
图2的编织物1由直径0.12mm的聚丙烯的单丝获得。
本发明的编织物的编织图案生成直径比大约1.0mm大的孔。例如，图2的编织物1的主要孔2具有2.0×2.4mm的平均尺寸。孔的这种大尺寸对细胞定植非常有帮助，且给予编织物良好透明性从而允许在植入部位处的良好的可见度。
本发明的编织物显现出在固定点处的剪切力的均匀分布。在固定点处的剪切力的分布可借助用于估定在基于纺织品(textile-based)的植入件的固定点处的剪切力分布的这种系统来评估，如参考图3和图4所描述的轴对称的实验布置，这种系统允许显现出纺织品的如下性能：在不考虑结合特定的几何学的情况下，在固定点处分布剪切力。
现在参考图3和图4，系统10包含组织模型100、负荷模拟设备200以及分析系统300，该分析系统用于估定基于纺织品的植入件400在固定至组织模型100且受到由负荷模拟设备200施加的负荷时的特性。组织模型100包含基部110，该基部具有沿平面“P”延伸的上表面112，并且基部110具有闭合的外边缘114，外边缘114限定贯穿其的开口116。上表面112配置为模拟腹壁的内表面：其为平的且为水平的。穿过上表面112限定的开口116配置为模拟腹壁中的缺损且在此可称作“缺损”。开口116在基部110的高度“H”全程具有圆形形状和统一尺寸和大小。在图3的系统中，开口116为具有带有10mm圆角(fillet)的55mm半径的空圆。
上表面112由具有如下的摩擦系数的涂层112a覆盖：该摩擦系数模拟腹壁的内表面对基于纺织品的植入件400的摩擦系数。摩擦系数为大约0.3。
基部110包含下平面118，该下平面从上平面112以预定的高度“H1”降低，且绕上表面112延伸。
基部110还包含呈多个杆120形式的固定支撑件，该固定支撑件配置为在两个以上的固定点处将基于纺织品的植入件400固定至其上。多个杆120在彼此20mm的预定距离“D1”处且离从上表面112末端70mm的预定距离“D2”处附接至下表面118。杆120排列成以开口116为中心的简单的圆冠固定。每一个杆120包含固定至下表面118的第一端120a、细长主体120b以及第二端120c，其中所述细长主体从下表面118朝向上表面112延伸且限定60mm的长度“L”，所述第二端终止在由上表面112限定的平面“P”附近或上方。细长主体120b从下表面118垂直地延伸。杆120为具有2.5mm的等效半径、以及110Gpa的杨氏模量的螺杆M3。
杆120配置为：当基于纺织品的植入件400放置在组织模型100的上表面112上且在上表面112中的开口116上方时，杆120直接固定至基于纺织品的植入件400的一部分。在基于纺织品的植入件400中的固定点处张力最小。标记122附接至杆120的第二端120c，以便标记122布置在由上表面112限定的平面“P”附近或上方。每一个标记122是在10mm直径的黑色圆内5mm直径的白色圆的形式，且位于基于纺织品的植入件400上方8mm处。标记122提供杆120的位置的视觉指示。标记122从两个经纱末端起分布在基于纺织品的植入件400的一半上。
负荷模拟设备200定位在基部110的上表面112上方，且配置为模拟在围绕组织模型100的环境的负荷条件的变化，以便绕组织模型100产生负荷的变化。负荷在此可被称作“腹内压等同物”。如所示地，负荷模拟设备200为包含接触表面212的柱塞210，该接触表面为半球状(直径100mm)且在穿过上表面112限定的开口116之上居中。柱塞210配置为沿与上表面112的平面“P”垂直的方向移动且对基于纺织品的植入件400施加预定力(以下称作“柱塞力”)，以便植入件400接合限定在组织模型100的上表面112内的开口116。负荷模拟设备200能够对基于纺织品的植入件400施加准静态压力(低的柱塞210下降速度)，以模拟各种生理条件。例如，施加的柱塞力可为147N，即116mmHg，其对应于在患者处于站立的瓦尔萨尔瓦条件下时的腹内压。可选择地，施加的柱塞力可为304N，即240mmHg，其对应于在患者跳跃时的腹内压。
分析系统300包含数字图像采集和处理部件310，该数字图像采集和处理部件包含用于记录标记122在3D坐标系中的位置的两个摄影机312、以及数字图像相关软件314，即，来自公司Correlated Solutions的Vic 3DTM，其用于计算因为响应于由负荷模拟设备200对基于纺织品的植入件400所施加的负荷而导致的杆120的弯曲所引起的每个标记122的位移矢量。分析系统300记录柱塞位移210。分析系统300还包含数学软件部件320，该数学软件部件被用来使用标记122的在平面“P”中的位移矢量分量、以及应用到杆120的连续介质力学理论，来计算存在有标记122的每个固定点处的剪切力矢量。因而，每一剪切力矢量为“腹内压等同物”的函数。数学软件部件320可包含任意的数值软件包，如来自公司Matchworks的
对基于纺织品的植入件400的通过开口116而鼓起的指示可通过估定穿过开口116的柱塞穿透度来给予。
在示范性使用方法中，如修复性编织物的基于纺织品的植入件400放置在组织模型100的基部110的上表面112上，以便植入件400沿由上表面112限定的平面“P”伸展。植入件400绕上表面112中的开口116居中放置，且如应该由本领域的技术人员所理解地，植入件400的纤维的方位相对于上表面112被控制。然后基于纺织品的植入件400直接固定至多个固定杆120。多个标记122然后贴到固定杆120的一部分，以便标记122在植入件400的经纱两末端之间延伸。
在植入件400固定至组织模型100的情况下，分析系统300起动，以便摄影机312捕捉标记122在3D坐标系中的位置。由于由负荷模拟设备200施加至植入件400的力传递至在固定点处的杆120从而导致杆120弯曲，因此经由摄影机312对标记122的位置/位置变化的采集与负荷模拟设备200的起动同步。因而，杆120的任何移动都导致标记122的移动，如上所述，标记122的移动由摄影机312记录且用于测定每一个固定点处的剪切力矢量。
如将从下面的实例变得明显的，图3和图4的系统允许评估修复性编织物的关于在固定点处的剪切力的分布、在固定点处的鼓起现象以及破裂的特性。
本发明的编织物的优点将在下面的实例中更清楚地显现。
实例：
现有技术的两个轻量的编织物(编织物A和编织物B)以及本发明的编织物(编织物C)已经如下文描述地生成。
编织物A：编织物A为如WO2011/042811中描述的现有技术的编织物，即通过依照ISO 11676标准，依照下面的图案，在具有两个梳栉B1、B2的经编机上编织0.08mm直径的聚对苯二甲酸乙二醇酯的单丝来获得：
-梳栉Bl:1.0/1.2/1.0/2.3/2.1/2.3/4.5/4.3/4.5/3.2/3.4/3.2//
-梳栉B2:4.5/4.3/4.5/3.2/3.4/3.2/1.0/1.2/1.0/2.3/2.1/2.3//
梳栉B1和梳栉B2以1满1空来穿线且对称性地运动。
编织物B：编织物B是如US6,408,656中描述的现有技术的编织物，即，通过依照ISO11676标准，依照下面的图案，在具有两个梳栉B1、B2的经编机上编织0.10mm直径的聚丙烯的单丝来获得：
-梳栉Bl:5.4/4.3/2.1/0.1/1.2/3.4//
-梳栉B2:0.1/1.2/3.4/5.4/4.3/2.1//
梳栉B1和梳栉B2以1满1空来穿线且对称地运动。
编织物C：是通过依照ISO 11676标准，遵循下述的图案，在具有两个梳栉B1、B2的经编机上编织0.12mm直径的聚丙烯的单丝来获得的具有图1编织图案的本发明的编织物：
-梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//
梳栉B1和梳栉B2以1满1空来穿线且对称地运动。
编织物A、B、C的下面的特性已经测定为如下：
-每单位面积的质量(g/m2)：依照ISO 3801:1977《每单位长度的质量和每单位面积的质量的测定》测量，1dm2内5个样本，
-孔尺寸(宽×高)(mm)：编织物最大孔通过轮廓投影仪(如来自ORAMA的300V投影仪)对10个单独的样本作出一次测量来测量，
-顶破强度(kPa)：依照ISO 13938-2:1999“纺织品-纺织品的顶破特性-用于测定顶破强度和顶破变形的气动法(Textiles-Bursting properties of textiles-Pneumaticmethod for determining the bursting strength and bursting deformation)”测量，5个样本，
-拉伸强度(N/cm)用牵引测试仪(如Hounsfield model H5KS(Hounsfield,雷德希尔，英国))通过柱塞测试来测量，滑块(crosshead)速度：50mm/min，5个样本：顶破压力能够使用被夹在外边框处的、具有Rm＝56.4mm的半径以及具有100cm2的测试面积的圆形网状件样本(改进的DIN 54307替代标准)来测定。然后，网状件通过速度v＝50mm/min的、半径RS＝50mm的球状冲头来加载，直到破裂出现为止。基于测量力和作为结果的伸展，能够计算拉伸强度(N/cm)；
-在经纱方向和纬纱方向上的撕裂强度(N)：依照ISO 4674:1977“橡胶或塑料涂层织物-撕裂强度的测定(Textiles covered with rubber or plastic-Determination ofthe tear strength)”方法A2来测量，5个样本，宽度：75mm，撕裂长度≤145mm，滑块速度：100mm/min，
-厚度：依照ISO 9073-2:1997“纺织品-非织造布试验方法-第2部分：厚度的测定(Textiles-test methods for nonwovens-Part 2:Determination of thickness)”来测量，10个样本，100×50mm，
-在断裂处的拉伸断裂强度和伸长率：依照ISO 13934-1:2013“纺织品-织物的拉伸特性-第1部分：用带样法测定最大受力和最大受力时的伸长率(Textiles-Tensileproperties of fabrics-Part 1:Determination of maximum force and elongation atmaximum force using the strip method)”来测量，5个样本，宽度：50mm，长度：在钳夹之间的200mm，滑块速度：100mm/min，预加载：0.5N，使用如Hounsfield model H5KS(Hounsfield，雷德希尔，英国)的牵引测试仪；
-有效孔隙率：具有超过1mm的直径的孔通过轮廓投影仪(如来自ORAMA的300V投影仪)来测量，1个100×50mm的样本；
-在经纱方向和纬纱方向上的缝合拔出强度依照NF S94-801:2007“由阴道路径导入的用于应力尿失禁和/或盆腔内器官的脱垂的治疗的增强植入件-临床前期试验和临床试验”-§5.3.3来测量，5个50×100mm的样本，USP 2缝合纱线，滑块速度：100mm/min，使用牵引测试仪(如Hounsfield model H5KS(Hounsfield，雷德希尔，英国))。
结果收集在以下表格中：
表I：机械特性
表II：每单位面积的质量和孔隙率
编织物A 编织物B 编织物C
每单位面积的质量(g/cm<sup>2</sup>) 45 36 46
厚度(mm) 0.4 0.4 0.6
孔尺寸(mm)(宽x高) 1.5x1.5 1.6x1.4 2.0x2.4
有效孔隙率(％) 53 35 55
参考上文的表I，本发明的编织物(编织物C)与现有技术的编织物(编织物A和编织物B)相比较显现出改善的机械特性。具体地，本发明的编织物显现出在经纱方向和纬纱方向上比编织物A和编织物B高的拉伸断裂强度。本发明的编织物显现出比编织物A和编织物B高的顶破强度。本发明的编织物显现出在经纱方向和纬纱方向上比编织物A和编织物B高的撕裂强度。
与现有技术的编织物(编织物A和编织物B)相比较，本发明的编织物(编织物C)显现出在经纱方向和纬纱方向上的改善的缝合拔出强度。本发明的编织物显现出在经纱方向和纬纱方向上比编织物A和编织物B高的拉伸强度。
参考上文的表II，与编织物A和编织物B相比较，本发明的编织物还显现出改善的有效孔隙率。
另外，图3和图4所描述的系统已经被用来估定在各种模拟的生理条件下的编织物A、B、C的以下特性。为了进行这些测量，图3和图4的基于纺织品的植入件400由待被评估的编织物A、B、C中任一个的编织物样本取代。
已经评估了以下特性：
1°)在编织物的固定点处的剪切力分布轮廓：对于每一个柱塞力，即分别为147N、304N，使用应用到杆的机械的连续介质力学理论，如上述的标记位移从初始固定位置转换成在存在有标记的每一个固定位置处的剪切力，其中，所述机械的连续介质力学理论在来自公司Matchworks的软件中实施。记录剪切力矢量。记录最大和最小矢量标准值(norm value)。在固定点处的剪切力的平均分布可在图5的形式下获得。
剪切力分布可通过图6来图示化。
平均力最小-最大(N)由如下来测定：在上文的轮廓的实例上，在147N柱塞力下的平均力最小-最大(N)是3.8-8，而在304N柱塞力下的平均力最小-最大(N)是7.1-13.5。
对于编织物，当平均力最小-最大的值的范围低时，编织物的故障的风险降低。编织物和因此腹壁修补将更有效。
另外，剪切力的轮廓越接近半圆或半椭圆，剪切力分布得越有规律。在特定方向上的拉紧的风险因此降低。另外，在全部方向上，力为相似值，因此，可以在不是必须对编织物的经纱或纬纱方向的特定位置检查的情况下，植入该编织物。编织物或由编织物制成的修复体对于患者也会更舒适。
2°)鼓起指示：对应于如图3和图4所描述的柱塞210的穿过的以mm表示的距离，所述距离为从其接触表面212与样本编织物相切的初始位置到在施加柱塞力之后获得的最终位置。
太高的鼓起指示(像例如在304N柱塞力时超过50mm或例如在147N柱塞力时超过45mm)可意指编织物/修复体可能对于确保其腹壁的加固功能来说过于柔软，和/或可意指可能产生不舒适感和/或审美干扰。
3°)在固定处的编织物的破裂：记录在固定点处的破裂的数量。
结果被收集在如下的表格中：
表III：剪切力的估定
如从上文的表格中显而易见的，本发明的编织物(编织物C)显现出非常接近于半圆的有规律的外形轮廓。剪切力因此有规律地分布。因此可以在外科医生不是必须对编织物的经纱或纬纱方向的特定定位进行预先检查的情况下，将本发明的编织物在植入部位处导入且植入。
另外，对于本发明的编织物，在固定点处的破裂的数量为0，而对于现有技术的编织物(编织物A和编织物B)，在固定点处的破裂的数量为2。因此一旦缝合或钉合到周围的生物组织，本发明的编织物比现有技术的编织物更可靠。
关于鼓起指示，本发明的编织物(编织物C)显现出在两个柱塞力时比现有技术的编织物更好的鼓起指示。本发明的编织物将因此确保其腹壁的加固功能，且在如跳跃或咳嗽的生理条件下将比现有技术的编织物更有效。

Claims (14)

1.一种基于生物相容的聚合物材料的单丝的修复性的有孔编织物，依照ISO 11676标准，所遵循的用于在具有两个梳栉B1、B2的编织机上编织所述单丝的图案为如下：
-梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//。
2.根据权利要求1所述的修复性的有孔编织物，其中所述生物相容的聚合物材料从聚丙烯、聚酯、聚酰胺、硅酮、聚醚醚酮(PEEK)、聚芳基醚酮(PAEK)、聚乳酸(PLA)、聚己酸内酯(PCL)、聚二恶烷酮(PDO)、三亚甲基碳酸酯(TMC)、聚乙烯醇(PVA)、聚羟基脂肪酸酯(PHA)、聚乙醇酸(PGA)、这些材料的共聚物、以及这些材料的混合物中来选择。
3.根据权利要求2所述的修复性的有孔编织物，其中所述聚酯为聚对苯二甲酸乙二醇酯。
4.根据权利要求1或2所述的修复性的有孔编织物，其中所述生物相容的聚合物材料为聚丙烯。
5.根据权利要求1或2所述的修复性的有孔编织物，其中所述单丝具有从大约0.08mm至大约0.25mm。
6.根据权利要求5所述的修复性的有孔编织物，其中所述单丝具有从大约0.10mm至大约0.15mm的直径。
7.根据权利要求1或2所述的修复性的有孔编织物，其中所述单丝具有大约0.12mm的直径。
8.根据权利要求1或2所述的修复性的有孔编织物，其中所述编织物包括具有超过1mm的直径的多个孔。
9.根据权利要求1或2所述的修复性的有孔编织物，其中所述编织物包括具有超过2mm的直径的多个孔。
10.根据权利要求8所述的修复性的有孔编织物，其中所述多个孔限定所述编织物的从大约35％至大约70％范围的有效孔隙率。
11.根据权利要求10所述的修复性的有孔编织物，其中所述多个孔限定所述编织物的大约55％的有效孔隙率。
12.一种用于制造权利要求1所述的修复性的有孔编织物的方法，包括依照ISO 11676标准，在具有两个梳栉B1、B2的编织机上依照如下的图案通过具有生物相容的聚合物材料的单丝生产编织物的步骤：
-梳栉Bl:1.2/4.5/4.3/4.5/4.3/1.0/1.2/1.0//
-梳栉B2:4.3/1.0/1.2/1.0/1.2/4.5/4.3/4.5//。
13.根据权利要求12所述的方法，其中梳栉B1和梳栉B2以1满1空来穿线且对称地运动。
14.一种疝修复体，其包括根据权利要求1至11中任一项所述的编织物或根据权利要求13所述的方法获得的编织物。
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