CN103079496A - 具有辐射透不过部件的修复体 - Google Patents
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Abstract
本发明涉及一种旨在于植入部位处植入的修复体(10),其包括:i)被称作基底织物(2)并且具有至少一个有孔表面(3)的至少一种织物;ii)和至少一个片(4),所述片设置有从其一个表面突出并且在所述基底织物的所述有孔表面上在特定位置处将所述片夹持地紧固至所述基底织物的所述有孔表面的至少一个倒刺(5),所述片包括至少一个辐射透不过部件。本发明还涉及包括织物和片的成套用具。
Description
技术领域
本发明涉及一种修复体,所述修复体基于织物并且包括对于外科医生的信息装置,所述信息装置被设计为便于在特定位置中植入修复体,和/或当修复体已被植入时,通过放射线透视,确定修复体的位置。
背景技术
许多修复体(例如,腹壁加固物或者尿失禁垫),采用生物相容织物片的形式,其可伴有或者不伴有附加的部件,例如,以膜的形式的涂层、加固部件、一套针等。这些修复体的织物片通常为对称的形状。用于加固壁(例如腹壁)的修复体尤其如此,通过暂时地或者确定地填充机能不全的组织,这些被广泛地用于外科领域并且被设计来治疗疝。取决于这些修复体必须适应的解剖结构,它们可为各种形状:矩形、圆形、椭圆形等。某些修复体完全地由生物可降解的纱制成,并且旨在于执行完它们的加固作用以后,直到细胞定殖形成和组织康复发生时消失。其他的修复体包括不能生物降解的纱并旨在永久保留在患者的身体中。
总之,为了安全原因,在植入时,这些修复体相对于周围的器官必须要以特定的和非常精确的方式定位。因此,为了向外科医生提供关于修复体的位置的指示的目的,尤其是当修复体已被植入时,有时需要向这些修复体提供标记或者信息装置。
因此,取决于植入部位的环境,例如,在存在内脏、软组织等时,在织物上的特定位置处向外科医生提供指示可能是重要的,从而他能够以特定的朝向定位织物片或者定位修复体的某个区域从而面向所述器官或者反之距所述器官尽可能远等。
为了能够识别植入的修复体的位置,使用修复体所设置有的辐射透不过部件从而能够在随后通过放射线透视来监测辐射透不过部件。根据本发明,术语“辐射透不过部件”应被理解为表示不能被X射线或者被电离辐射透过而是能够通过放射线照相或者通过放射线透视看到的不透明部件。
然而,提供具有辐射透不过部件的修复体不是止痛药(anodyne)。为了最大限度地使患者体内存在的辐射透不过物质最小化,外科医生可能期望能够确定他希望引入到修复体中的辐射透不过部件的量以及在修复体的什么位置处引入。例如,在即将植入前,外科医生具有用于容易地和快速地提供具有一个或多个辐射透不过部件的修复体的装置将是有利的。
因此,仍需要能够可靠地和快速地提供具有辐射透不过部件的修复体的织物,并且不破坏所述辐射透不过部件和修复体自身的有效性。
发明内容
本发明的目的是通过提供基于织物的修复体来满足这种需求,修复体具有容易安装到所述织物上的辐射透不过部件,并且辐射透不过部件对修复体的定位及其效果没有消极影响。
本发明的第一方案为旨在于植入部位处植入的修复体,其包括:i)被称作基底织物并且具有至少一个有孔表面的至少一种织物;ii)和至少一个片(patch),所述片设置有从其表面中的一个表面突出并且在所述基底织物的所述有孔表面上的特定位置处将所述片夹持地紧固到所述基底织物的所述有孔表面上的至少一个倒刺,所述片包括至少一个辐射透不过部件。
术语“织物”在本申请的上下文中应被理解为表示通过生物相容性的纱、纤维、单丝和/或多丝的布置或者组装得到的(例如,针织织物、编织织物、编结织物或者无纺织物)并具有两个相对的表面的任何织物。
根据本发明的修复体的基底织物的至少一个表面是有孔的。术语“有孔表面”根据本发明应被理解为表示所述织物的所述表面包括对外开放的开口、洞、孔或者空穴。所述开口促进细胞向织物的渗透并因此在植入后形成修复体的细胞重新定殖。如将在以下的描述中变得显而易见的,根据本发明的修复体的基底织物的有孔表面中的开口具有这样的大小:通过它们的由构成织物的纱形成的壁使它们能够接收和保持根据本发明的修复体的一个片或多个片的一个倒刺或多个倒刺。
根据本发明的修复体可以以特别简单和快速的方式产生。具体地,为了包括辐射透不过部件,修复体的基底织物不必进行任何特别的处理。这足以提供具有一个或多个片的织物,所述片可以例如由包含至少一种辐射透不过的纱的夹持织物制备并且在特定位置夹持地紧固至基底织物,当将修复体植入患者时,通过拍摄修复体的放射线透视图像,可以向外科医生提供关于修复体位置的适当信息。
根据本发明的修复体,虽然设置有辐射透不过部件,但是没有失去基底织物的初始特性。尤其地,当所述片是由包含辐射透不过的纱的有孔夹持织物制成时,根据本发明的修复体的基底织物的有孔表面保持其良好的细胞重新定殖能力。
根据本发明的修复体可包括多个上述的片,它们被夹持地紧固在所述基底织物的有孔表面的特定位置处。
因此,对于长方形或正方形的基底织物,外科医生可以将片放置在织物各个角落从而在植入修复体时能够更容易地确定整个修复体的位置,例如,借助于在刚植入后产生的第一张手术后的放射线透视图像和然后例如在植入后几个月拍摄的一张或多张其他的放射线透视图像,不同放射线透视图像之间的比较可以使外科医生看到修复体是否移动或者修复体是否变形(例如通过基底织物的缩小或者收缩)。
根据本发明的修复体的基底织物可使其两个表面是有孔的。在这种情况下,一个或多个片可以夹持地紧固到织物的两个表面中的每一个表面,这种构造使得能够在植入后几星期或几个月通过放射线透视确定修复体的厚度,并因此例如确定其完整性的状态。
根据本发明的修复体的基底织物可为基于生物相容性的纱、丝或纤维的任何织物,例如编织、无纺、编结、针织织物或者后者的组合,只要其表面中的至少一个表面是有孔的。
根据本发明形成基底织物的纱、纤维或单丝和/或多丝可由任何生物相容性的材料制成,不论是否是可生物降解的材料。
术语“可生物降解的”或“可生物吸收的”在本申请的上下文中应被理解为表示这样的特征:取决于材料的化学性质,一种材料被生物组织吸收或降解并且在可以从例如几个小时到几个月的特定时间段后在体内消失。
因此,适合于本发明的基底织物的纱的可生物降解的材料可选自聚乳酸(PLA)、聚乙醇酸(PGA)、氧化纤维素、壳聚糖、聚磷腈、聚己酸内酯(PCL)、聚二噁烷酮(PDO)、三亚甲基碳酸酯(TMC)、聚乙烯醇(PVA)、聚羟基烷酯(PHAs)、聚酰胺、聚醚、其共聚物和其混合物。适合于本发明的基底织物的纱的不能生物降解的材料可选自聚对苯二甲酸乙二醇酯(PET)、聚酰胺、芳族聚酰胺、膨体聚四氟乙烯、聚氨酯、聚偏二氟乙烯(PVDF)、丁酯聚合物、PEEK(聚醚醚酮)、聚烯烃(例如聚乙烯或聚丙烯)、铜合金、银或者铂合金,医用级的钢例如医用级的不锈钢,及其组合。
在本发明的一个实施方式中,所述基底织物为针织物:由于构成针织物的网孔,针织物提供了尤其十分适合于根据本发明的修复体的有孔表面。所述针织物可为二维或三维的。
术语“二维针织物”在本申请的上下文中应被理解为表示具有通过网孔连接在一起的相对的两个表面但是没有给予它们一定厚度的间隔物的针织物,这种针织物例如可以通过使用两个导针杆在经编机或者拉舍尔针织机上针织纱来得到。针织适合于本发明的具有至少一个有孔表面的二维针织物的示例在专利文献WO2009/071998中给出。
术语“三维针织物”根据本申请应被理解为表示具有通过给予针织物显著厚度的间隔物连接在一起的两个相对的表面的针织物,除了形成针织物的两个表面的纱以外,所述间隔物自身可由另外的连接纱形成。这种针织物可以例如使用几个导针杆在双座经编机或者拉舍尔针织机上得到。针织适合本发明的具有至少一个有孔表面的三维针织物的示例在专利文献WO99/05990、WO2009/031035和WO2009/071998中给出。
本发明基底织物可为多孔的织物或针织物,即,具有洞、孔或者空穴的织物或针织物,不仅在其表面上而且在其厚度内,这些洞、孔或者空穴能够构成出现在织物的任一侧的槽。这种多孔织物能使组织更好地结合,能够使细胞接近形成例如腹壁加强物的织物的内部。
例如,在基底织物的厚度内,基底织物的式样可以决定多个横向的洞或槽,几乎互相平行,在其两个相应的有孔表面上出现在所述织物的任一侧,例如给予织物“蜂窝”的结构。
根据本发明的修复体的一个片或多个片可由任何生物相容性的材料制成并且包括至少一个辐射透不过部件。
所述辐射透不过部件可由任何生物相容性的辐射透不过材料制成。尤其适合于本发明的辐射透不过材料的示例为金、钯、钽、铬、银、氧化锆、钨、铂、硫酸钡(BaSO4)、氧化铋(Bi2O3)、碘和衍生的产物、钆、铝硅酸盐、生物相容性的磷质石灰陶瓷(例如羟磷灰石或者磷酸三钙)、及其混合物。
根据本发明的修复体的一个片或多个片可具有可想象的任何形状,例如,几何形状(例如椭圆形、圆形或矩形),或者图形形状,例如箭头形、符号形,一般来说,为了最大限度地使患者体内存在的异物最小化,所述片可具有适合于辐射透不过部件的必要剂量的大小从而使辐射透不过部件能够被放射性透视检测到,所述剂量保持远在辐射透不过部件的毒性阈值剂量之下。因此,根据放射线照相所需的射线不透性调整辐射透不过部件的量。
根据本发明的修复体的一个片或多个片设置有至少一个,优选几个,从它们的一个表面突出的倒刺。这些倒刺可以以基本垂直于所述表面的平面从所述表面突出或者可选地沿着向所述表面的平面倾斜的一个或多个平面突出。由于受到施加到从片上到基底织物上的压力的影响,通过渗透进入开口并且在形成有孔表面或者根据本发明的修复体的基底织物的表面的开口的纱中相互作用,这些倒刺旨在用作紧固装置。有利地,如果需要,在制备根据本发明的修复体的时候,通过拉动所述片,还可以将这些倒刺取出,然后可以重新定位在基底织物的有孔表面的其他位置上。
因此,如果暂时需要,可以将片夹持地紧固到根据本发明的修复体的基底织物上。因此,在一个实施方式中,一个倒刺或多个倒刺以能够重新定位的方式将一个片或者多个片夹持地紧固到基底织物的有孔表面。
可选地,通过在所述片和基底织物之间加入一点粘合剂或者缝合线,可以确切地将一个或者多个片固定至基底织物的有孔表面。
所述倒刺由生物相容性材料制成,其可与形成片体的材料相同或不同。在本发明的一个实施方式中,所述倒刺由辐射透不过的材料制成并且构成所述片的辐射透不过部件。
根据本发明的修复体的片可以通过生物相容性的热塑性塑料的注塑成模来制备。
在一个优选的实施方式中,根据本发明的修复体的片由夹持织物制成。
在本申请中,术语“夹持织物”应被理解为表示这样的织物:在其至少一个表面上,具有以规则或随机的方式布置的多个钩或倒刺,它们基本上垂直于所述表面突出并且能够穿透其被应用到的有孔织物的表面或厚度。已知的夹持织物的一个示例为体系的夹持部。因此,根据本发明的片的倒刺可由纱形成,例如,热塑性塑料单丝纱,直接来自于形成片的纱的布置。这种织物和倒刺及其制备方法例如记载在专利申请WO01/81667、DE19832634或者专利US6596002和US5254133中。
可选地,所述夹持织物的倒刺可为由任何生物相容性材料制成的任何钩,紧固到形成所述织物的纱的布置中,不论这些钩在制备所述纱的布置(编结、针织、编织等)的过程中被引入到所述织物中还是在以后附着到所述织物上。
在优选的实施方式中,所述倒刺来自于用于针织所述夹持织物的纱。例如,如在WO01/81667中记载的,所述夹持织物一般可包括单丝的圈,在所述圈的外面最初形成小的环,在部分熔化最初形成环的热塑性塑料之后,各个环产生垂直于所述圈突出的两个倒刺。
因此,形成根据本发明的修复体的片的夹持织物可包括它的一些由辐射透不过的材料形成的组成纱。这些纱可为形成夹持织物的倒刺的纱或者形成夹持织物体的纱,或者为两者的组合。在该实施方式中,所述辐射透不过部件是由形成夹持织物的一种纱或多种纱构成。
优选地,限定倒刺的长度从而穿透并且钩住基底织物的有孔表面,优选地以有限的方式,也就是说如果可能没有从基底织物的一侧穿过到另一侧。
就在执行植入操作之前,设置有辐射透不过部件的根据本发明的修复体因此可以由外科医生自己在手术部位上很容易地制备。
例如,外科医生足以使包括辐射透不过部件的片借助于它们的倒刺将基底织物夹持在所需的位置处;而且,如果在第一次紧固这些片时出现差错,当这些片已被夹持地紧固时,外科医生还可以容易地除去它们并然后将它们紧固到更合适的位置。
在优选的实施方式中,如上所述,使用的夹持织物自身是有孔的和/或多孔的。因此,一旦所述片被夹持地紧固至基底织物的有孔表面,它丝毫不会阻塞基底织物的有孔表面中的开口,从而保持其良好的细胞重新定殖能力。例如,所述片的织物结构包括或者限定,在其两个表面上,具有倒刺,具有例如0.4mm和5mm之间的直径的开放孔。在一个实施方式中,所述片可以在其两个表面上设置有倒刺。
在本发明的一个实施方式中,所述片由在WO01/81667中描述的夹持织物制成并且包括由辐射透不过的材料制成的至少一种它的组成纱。尤其适合于制备根据本发明的修复体的片的由辐射透不过的材料制成的纱的示例为例如在文献US7465489中描述的那些纱。
例如,各倒刺可具有1mm和2mm之间的长度并且所述倒刺的密度可在每平方厘米30个倒刺至50个倒刺的范围内:这种密度能够使所述片可以被夹持地紧固至基底织物和/或如果需要可以容易地从此除去从而重新定位。
可选地或组合地,所述辐射透不过部件可以采取由沉积在所述片的至少一个表面上的辐射透不过材料制成的涂层的形式。例如,不论其是否是由夹持织物制成,通过上述的辐射透不过的化合物(尤其选自金、钯、钽、铬、银、氧化锆及其混合物中的那些)的化学气相沉积(CVD)或者可能的等离子体增强的化学气相沉积(PECVD)形成的辐射透不过的涂层,来涂覆所述片的至少一个表面。
在一个实施方式中,所述辐射透不过部件为由辐射透不过材料(例如金)制成的涂层的形式,通过等离子体增强的化学气相沉积而沉积在所述片的各表面。
在另一实施方式中,所述辐射透不过部件可被包含在基质(例如,聚丙烯基质)中,形成与所述片的一个表面结合的膜。
当这种夹持织物以片的形式被应用(倒刺在前面)在基底织物的有孔表面上时,所述倒刺接合网眼并且在基底织物的纱之间,并且将所述片锁定到基底织物的有孔表面上。这种锁定效果,甚至在液体介质中也是有效的,足以将所述片固定到基底织物上,如果需要,仍可以使所述片松开从而调节其相对于基底织物的位置。
本发明的另一方面为成套用具,其包括:
-如上所定义的被称作基底织物并且具有至少一个有孔表面的至少一种织物,被设计为在植入部位被植入;和
-至少一个片,所述片设置有从其一个表面突出的至少一个倒刺并且包括至少一个辐射透不过部件,一个倒刺或多个倒刺被设计为在所述基底织物的有孔表面上在特定位置处将所述片夹持地紧固至所述基底织物的有孔表面。根据本发明的所述成套用具的片可为如上所述。根据本发明的成套用具可包括多个上述的片。
附图说明
根据以下的描述和附图,本发明的优点将变得更加显而易见,在附图中:
图1为根据本发明的成套用具的俯视图;
图2为根据本发明的修复体的片的剖视图;和
图3为根据本发明的修复体的俯视图。
具体实施方式
有益地参考图1,根据本发明的成套用具总体通过附图标记1表示。成套用具1包括以总体上为矩形的织物片2的形式的基底织物。织物片2可具有4cm2至1600cm2范围的面积并且可以有利地用于修复腹壁疝。织物片2具有两个表面,在图中可以看到其有孔表面3。
可以使用以下方法来得到具有至少一个有孔表面的这种织物:根据ISO11676,使用下列方案,使用聚对苯二甲酸乙二醇酯(PET)多丝纱(50分特(dtex);22丝)按照一个满/一个空的方式穿线,使用6个导针杆,在22隔距拉舍尔针织机上生产三维针织物。
杆1:1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1/1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2//
杆2:1.2.2.2/3.2.2.2/1.2.2.2/3.2.2.2/1.2.1.1/1.0.1.1/1.2.1.1/1.0.1.1//
杆3:0.1.0.1/0.0.0.0//
杆4:0.1.0.1/0.0.0.0//
杆5:1.1.0.1/1.1.2.1/1.1.0.1/1.1.2.1/2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1//
杆6:2.2.2.3/2.2.2.1/2.2.2.3/2.2.2.1/1.1.0.1/1.1.2.1/1.1.01/1.1.2.1//
杆1和杆2形成织物的一个表面,杆5和杆6形成织物的相对表面,以及杆3和杆4形成将两个表面连接在一起的间隔物。
这种构造导致在其两个表面上具有尺寸为大约2.5mm×1.7mm的开口的三维针织物。
图1还显示了各自采取圆盘的总体形状的四个片4。如图2所示,这些片中的每一个设置有垂直于它们的表面中的一个表面突出的倒刺5,图2为片4的剖视图。
在这个示例中,片4是由按照下列方式得到的夹持织物制成:使用3个导针杆在24隔距纬编机上生产的针织物。根据ISO11676,根据以下方案,
旨在形成夹持织物体的杆1和杆2,使用0.09mm直径的聚对苯二甲酸乙二醇酯(PET)单丝纱按照一个满/一个空的方式穿线:
杆1:1.0/0.1//
杆2:4.5/1.0//
根据ISO11676,根据以下方案,旨在形成产生倒刺的单丝的圈的杆3,使用0.15mm直径的聚乳酸(PLA)单丝纱按照一个满/三个空的方式穿线:
杆3:3.4/0.0/2.1/5.5//
根据在WO01/81667中描述的方法,然后通过熔化由杆3产生的圈的环制备所述倒刺。
然后通过等离子体增强的化学气相沉积(PECVD)用金涂覆夹持织物的两个表面。
接下来,将得到的经涂覆的夹持织物切成四片:取决于放射照相所需的射线不透性,这些片可具有例如从0.5cm2至6cm2范围的面积。
图3显示了由图1的成套用具1产生的根据本发明的修复体10。为了产生修复体10,具有指向于基底织物片2的有孔表面3的倒刺5的四个片4,被简单地应用在其上并在其上施加压力。四个片4被应用到基底织物的有孔表面3上的特定位置处,即各在基底织物2的一个角,一旦所述修复体被植入,使得外科医生通过放射线透视能够容易地确定修复体的位置。在植入后的几星期或几个月,可由此检查修复体10在患者体内的位置。
由此以简单和特别快速的方式产生了修复体10。其尤其可以容易地由外科医生自己刚好在植入前产生。
在一个未图示的实施方式中,所述四个片可各包括由限定特定形状(例如,圆形、十字形和三角形等)的辐射透不过材料制成的纱,以使外科医生可以准确地确定修复体的哪个角被放在哪个位置。
Claims (11)
1.一种旨在于植入部位处被植入的修复体(10),其包括:i)被称作基底织物(2)并且具有至少一个有孔表面(3)的至少一种织物;ii)和至少一个片(4),所述片设置有从其一个表面突出并且在所述基底织物的所述有孔表面上的特定位置处将所述片夹持地紧固至所述基底织物的所述有孔表面的至少一个倒刺(5),所述片包括至少一个辐射透不过部件。
2.根据前述权利要求所述的修复体(10),其特征在于,所述修复体包括各包括至少一个辐射透不过部件的多个片(4),所述片被夹持地紧固至所述基底织物的所述有孔表面上的特定位置。
3.根据权利要求1或2所述的修复体(10),其特征在于,所述基底织物具有两个有孔表面,一个片或多个片被夹持地紧固至所述两个有孔表面中的每个有孔表面。
4.根据前述任一项权利要求所述的修复体(10),其特征在于,所述基底织物为针织物。
5.根据前述任一项权利要求所述的修复体(10),其特征在于,所述倒刺是由辐射透不过材料制成并构成所述片的所述辐射透不过部件。
6.根据前述任一项权利要求所述的修复体(10),其特征在于,所述一个片或多个片是由夹持织物制成。
7.根据权利要求6所述的修复体(10),其特征在于,所述辐射透不过部件是由形成夹持织物的一种或多种辐射透不过的纱组成。
8.根据权利要求6或7所述的修复体(10),其特征在于,所述夹持织物是有孔的。
9.根据前述任一项权利要求所述的修复体(10),其特征在于,所述辐射透不过部件为涂层的形式,所述涂层是由沉积在所述片的至少一个表面上的辐射透不过材料制成。
10.根据前述任一项权利要求所述的修复体(10),其特征在于,所述辐射透不过部件为涂层的形式,所述涂层是通过等离子体增强的化学气相沉积而沉积在所述片的各表面上的辐射透不过材料制成。
11.一种成套用具(1),其包括:
根据权利要求1-7中任一项所定义的被称作基底织物(2)并且具有至少一个有孔表面(3)的至少一种织物,被设计为在植入部位处被植入;和
至少一个片(4),所述片设置有从其一个表面突出并且包括至少一个辐射透不过部件的至少一个倒刺(5),一个或多个所述倒刺被设计为在所述基底织物的所述有孔表面上的特定位置处将所述片夹持地紧固至所述基底织物的所述有孔表面。
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Also Published As
Publication number | Publication date |
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JP5896538B2 (ja) | 2016-03-30 |
CA2805497C (en) | 2018-08-07 |
EP2593037A1 (en) | 2013-05-22 |
AU2011278230B2 (en) | 2015-08-27 |
JP2013535245A (ja) | 2013-09-12 |
CA2805497A1 (en) | 2012-01-19 |
AU2011278230A1 (en) | 2013-01-31 |
CN103079496B (zh) | 2016-01-20 |
FR2962646A1 (fr) | 2012-01-20 |
US10076395B2 (en) | 2018-09-18 |
US20130158572A1 (en) | 2013-06-20 |
WO2012007579A1 (en) | 2012-01-19 |
EP2593037B1 (en) | 2014-03-26 |
FR2962646B1 (fr) | 2012-06-22 |
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