CN103764068B - 脐疝修复体 - Google Patents
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- 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
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- 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
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Abstract
本发明涉及一种脐疝修复体(200),包括:-由外围部边缘(1a)定界的至少一个柔性网格(1),-从所述网格的一个面延伸出的至少两个舌状物(5),以及-用于加强所述网格的至少一个构件,其特征在于所述加强构件具有框架(2)的形式,所述框架(2)被紧固至所述网格并且大致上采用所述网格的所述外围部边缘的形状,所述框架从所述外围部边缘缩回并且设置有两个铰接点(3a,3b),穿过所述两个铰接点的线也穿过所述网格的中心(1b)并因此形成用于将所述网格折叠成两部分的线M。
Description
技术领域
本发明提供一种例如用于修复疝的修复体,其包括网格和用于加强该网格的构件。
背景技术
人的腹壁由脂肪和通过腱膜互相连接的肌肉组成。在连续性方面的破坏可能发生在腱膜层,使得部分腹膜穿过并形成囊,包含脂肪或者肠的一部分,这公知为疝。疝或腹部破裂(发生在腔壁的外科手术伤痕上的疝)由皮肤表面上的突出表现出来,并且它们例如以它们的位置为特性被称为脐疝或腹股沟疝或腹部破裂。
为了修复疝,外科医生常常安装合成网格修复体,其替代或加强虚弱的解剖组织。
然而,修复体的疗效很大程度上依赖于修复体的适当的固定,并从而使得复发的风险最小化。特别是,在修复体被固定之前,其应当正确地覆盖在意图被加强的腹壁上。网格型修复体(即基于形成织物的线排列的)通常是柔性的,并且为了将它们引入到疝中,它们常常被折叠以减小它们的体积。因此,当它们被引入到植入部位上时,它们倾向于在腹壁上起皱。在这方面,将它们伸展开是最重要的但被证明可能是困难的,特别是在治疗脐疝的情形下,小于腹股沟疝的脐疝提供了用于由外科医生操作修复体的极小的工作空间和微弱的可见度。
例如,在脐疝的情形下,或者在治疗目的是用于修复套管针孔或治疗目的是预防性的时,待治疗的缺损的尺寸很小,例如直径为1cm至4cm,并且可以正视打开的手术部位而不加宽该缺损。然而,在这种类型的手术部位中,外科医生具有极小的工作空间和微弱的可见度。如果可能避免在修复体的外围处缝合的需要,在这种工作条件下的缝合是复杂的并且费力的,则因此优选地具有易于定位、伸展开和固定的修复体。
使修复体完全地抵靠腹壁伸展开的失败会导致限制腹膜囊的风险和在修复体与腹壁之间插入软器官的风险,这可能导致粘连、疼痛和肠阻塞的风险并且增加复发的可能性。因此外科医生需要确信修复体没有任何一部分保持折叠并且在修复体和腹壁之间没有肠的任一部分或内脏。此外,缝合线的不正确定位或修复体的不正确固定将引起修复体扭曲并产生张力的风险。
发明内容
从而特别是在脐疝的情形下,具有用于引入修复体的狭小的孔,可能有益的是具有一种修复体,其适于在第一结构中占用小体积,以便于经由该孔将其引入到腹腔之中并随后被展开,易于抵靠腹壁被伸展开并被挤压,使得外科医生确信修复体的最佳定位并且此外可以有效地固定该修复体而不在其外围处缝合,并且这样可以不管小尺寸疝的微弱的内部可见度。
能够得到可以被折叠起来的并随后被展开的多种修复体。
本发明关注适于被折叠起来的修复体,以减少在其被引入到小切口中时占用的体积并且在另一方面易于伸展开并固定,使得外科医生确信完全地伸展了该修复体并且该修复体可以被有效地固定在该修复体的中心与其外围之间的一定距离处而不需要在该修复体的外围处的缝合,并且这样可以不管小尺寸疝的微弱的内部可见度。
本发明的修复体有益于治疗腹壁的疝,特别是用于治疗小缺损处的脐疝。
本发明的第一个方案提供了一种修复体,包括:
-由外围部边缘定界的至少一个柔性网格,
-从所述网格的一个面延伸出的至少两个舌状物,以及
-用于加强所述网格的至少一个构件,其特征在于所述加强构件具有框架的形式,所述框架被紧固至所述网格并且大致上采用所述网格的所述外围部边缘的形状,所述框架从所述外围部边缘缩回并且设置有两个铰接点,穿过所述两个铰接点的线也穿过所述网格的中心,并因此形成用于将所述网格折叠成两部分的线。
所述加强构件或框架可以是刚性的或具有一些柔性。根据本发明,由于所述框架的所述两个铰接点的存在,不管所述框架的内在弹性性能是否存在,所述网格以及由此的所述修复体都可以被折叠成两部分。
在本申请的上下文中,术语“网格”指的是生物相容的线的布置,例如针织的、编织的或无纺织的材料,优选为透孔织物种类(即,具有促进细胞定殖(recolonization)的气孔)。这种网格可以是可生物吸收的、部分可生物吸收的或者不吸收的(permanent)。其足够柔性而能在修复体被引入至腹腔中时被折叠起来。所述网格可以由一层织物或由多层织物制造。这些网格对本领域技术人员而言是公知的。可用于本发明的所述网格可以以任何形状(矩形、正方形、圆形、椭圆形等等)提供,并随后被切割以匹配所述疝缺损的形状。例如,所述网格可以总体上具有圆盘形或椭圆形的形状:在这种情形下所述框架也具有圆形或椭圆形并且优选为环形的形式。可选地,所述网格可以具有整体上(globally)正方形或矩形的形状:在这种情形下所述框架也具有正方形或矩形的形状。所述框架从所述网格的所述外围部边缘缩回:从而,在采用所述网格的轮廓的形状的同时,所述框架具有的外部周界小于所述网格的所述外围部边缘的外部周界:换句话说,所述网格的所述外围部边缘延伸为以一定距离超出所述框架。例如,该距离可以大于或等于1mm。换句话说,所述框架和所述网格的所述外围部边缘是相似的几何形状但是所述框架示出的尺寸小于所述网格的所述外围部边缘的尺寸。
就像在下面的描述中将变得显而易见的一样,从所述网格的所述外围部边缘略微缩回的所述框架的形状及其位置使外科医生能够在植入所述修复体时,将修复体有效地固定到所述腹膜而不需要在所述网格的外围处缝合:外科医生能够将所述修复体仅沿所述框架的内部轮廓固定,所述内部轮廓限定了缝线的固定路线:这避免了外科医生不得不在所述网格的所述外围部边缘处将缝线施加到所述修复体,由于所述切口的尺寸小,因此所述外围部边缘是难以达到并且几乎难以看见的。本发明的所述修复体的所述框架的所述内部轮廓限定了固定路线或缝合路线,固定路线或缝合路线被定位在所述网格的中心与其外围部边缘之间的大约中间处,外科医生在其将所述修复体固定到所述腹壁时,可以沿固定路线或缝合路线来定位所述缝线。然而,将所述修复体完全地伸展开是由所述框架的存在来确保的,所述框架通过采用所述外围部边缘的轮廓形状,确保了展开所述修复体并将其挤压到所述腹壁上。
在本发明的一个实施例中,所述网格是针织物:由于形成它的缝线,针织物使其能够获得透孔面,透孔面在被植入后促进了细胞的定殖。所述针织物可以是二维针织物或三维针织物。
在本发明的上下文中,该表述“二维针织物”表示具有通过缝线联结在一起的两个相对面但是不具有给予针织物一定厚度的隔离物的针织物:例如,通过使用两个导针杆在经编机或拉舍尔针织机上针织线,可以获得这种针织物。在专利文献WO2009/071998中给出了适合本发明的二维针织物的示例。
在本申请中,该表述“三维针织物”表示具有通过给予针织物显著厚度的间隔物而联结在一起的两个相对面的针织物,所述间隔物由除形成所述针织物的所述两个面的线之外的连接线组成。例如,使用具有多个导针杆的双座拉舍尔针织机或者经编针织机,可以获得这种针织物。在专利文献WO99/05990、WO2009/031035和WO2009/071998中给出了针织适合本发明的三维针织物的示例。
在一个实施例中,所述框架从所述外围部边缘缩回并且所述框架为蜿蜒的形状,形成了波浪。例如,所述框架是平坦的带形,大致在所述网格的平面上形成波浪。就像在下文给出的描述中将变得显而易见的一样,所述框架的这种配置使得,当将所述修复体固定到所述生物组织时,能够在该操作期间在给定位置处执行在修复体中的缝合,而不使得所述修复体整体变形;在所述给定位置处由所述缝合造成的所述修复体的变形通过波浪的框架而被消除。因此,在固定所述修复体期间,所述框架并因此所述修复体的其余部分保持正确的定位,并且特别是保持抵靠所述腹壁被挤压。此外,所述框架优选地沿其截面具有一定刚性。
在一个实施例中,所述加强构件以可生物吸收的材料制造。从而所述加强构件实现了在定位和植入所述修复体期间使所述修复体变硬的任务并且一旦所述网格被周围细胞定殖,所述加强构件随后逐渐降解。
可以从例如聚乳酸(PLA)、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(PHA)、氧化纤维素、聚乙醇酸(PGA)以及这些材料的共聚物及其混合物中选择所述可生物吸收材料。
可选地,所述加强构件以从聚丙烯、诸如聚对苯二甲酸乙二醇酯的聚酯、聚酰胺、硅树脂、聚醚醚酮(PEEK)、聚芳基醚酮(PAEK)及其混合物中选择的非可生物吸收材料制造。
在另一个实施例中,所述加强构件由可生物吸收材料和非可生物吸收材料的组合来制造。
在一个实施例中,所述舌状物具有整体上矩形的形状并且在它们的端部中的一个端部处设置有将它们固定到所述网格的加宽部。就像从下文给出的描述中将变得显而易见一样,由于所述舌状物便于将所述修复体定位在所述待治疗的缺损的中心处并且将所述修复体固定到所述生物组织,所述舌状物对外科医生是有用的。
在本发明的一个实施例中,所述舌状物是织物舌状物。所述舌状物的织物可以与所述网格的织物相同或不同。所述舌状物可以由可生物吸收材料或者非可生物吸收材料制造。用于制造所述舌状物的适当的可生物吸收材料可以从用于所述加强构件的以上提及的可生物吸收材料中选择。
在本发明的一个实施例中,所述加宽部与所述舌状物的其余部分分离,所述加宽部以夹持织物(grippingtextile)制造并可因此被任意地附接到和/或脱离于所述舌状物的其余部分。在专利文件WO0181667中描述了制造夹持织物的示例。
例如,所述舌状物的所述加宽部可以被缝到所述网格上。所述加宽部使所述舌状物能够更好地固定到所述网格。在一个实施例中,所述舌状物的所述加宽部借助于所述加强构件被固定到所述网格。
在本发明的一个实施例中,所述两个舌状物被固定到所述折叠线的任一侧上,优选地被固定到关于该折叠线对称的两个位置。
在本发明的一个实施例中,所述网格具有圆盘形状,所述框架大致为圆环的形式,并且所述舌状物被固定在所述环上的两个在直径上相对的位置,所述两个位置与所述两个铰接点中的每一个均间隔90°。包括所述两个舌状物的所述网格的面可以设置有两个附加的舌状物,所述两个附加的舌状物在所述环的所述两个铰接点的位置处被固定到所述网格上。
在本发明的一个实施例中,所述舌状物的至少一部分的颜色与所述网格的颜色不同:例如,所述舌状物的加宽部的颜色可以与所述网格的颜色不同。事实上,考虑到由所述工作区域的尺寸小而提供的微弱的可见性,在所述舌状物的所述加宽部(或者整个舌状物)与所述网格之间的颜色差异是特别有利的:这种颜色差异允许限定了一线,所述线给外科医生指出在哪里完成用于将所述修复体固定到所述腹壁的缝合。
在实施例中,所述网格是圆盘形并且所述框架大致上为圆环的形式,所述修复体包括四个所述舌状物,所述舌状物的加宽部的颜色与所述网格的颜色不同,所述四个加宽部沿所述环的内部轮廓相对于所述折叠线M对称地分布,所述加宽部中的两个在所述折叠线M的一侧,所述加宽部中的另外两个在所述折叠线M的另一侧。
在实施例中,所有四个加宽部都呈现出织物的等腰三角形的形式,每个三角形经由其底部(base)被固定到所述网格,所有四个三角形都表现出在向心方向上的同样的伸长性能和抗张强度性能。
例如,每个等腰三角形借助于所述环经由该等腰三角形的底部被固定到所述网格,所述舌状物的所述矩形部附接至所述等腰三角形的顶角。由于织物的所述四个等腰三角形在向心方向上具有相同的机械性能,因此当外科医生在将所述修复体放置在适当的位置并且将其固定到所述腹壁时拉起所述四个舌状物的所述矩形部时,所述舌状物的所有加宽部都做出相似的反应并且由外科医生经由所述四个舌状物在整个修复体上施加的牵引是规则地分布的。因此适当地定位了所述修复体。此外,由于织物的所述四个等腰三角形具有与所述网格的颜色不同的颜色,因此外科医生容易识别像以上限定的那样的缝合线并且便于将所述修复体固定到所述腹壁的步骤。就像从下面的描述中将会显而易见的那样,制造呈现出织物的四个等腰三角形(四个等腰三角形具有同样的机械性能)形式的四个加宽部的修复体是简单并且容易的。
在本发明的一个实施例中,所述舌状物的自由端通过定心线接合在一起。就像从下面给出的描述中将变得显而易见的一样,这种配置使外科医生在植入所述修复体时能够使用定心线特别容易地并且有效地定位并固定所述修复体。
在本发明的一个实施例中,所述网格的与包含所述舌状物的面相反的面覆盖有非粘着的涂层。
这种涂层尤其能够避免有害的严重的手术后纤维粘着的形成。
在本发明的上下文中该表述“非粘着性”指的是非多孔的、光滑的、生物相容的涂层或材料,该涂层或材料不提供用于细胞定殖的空间并且优选地促进了腹膜的生成。
附图说明
从下文给出的说明书中以及从附图中,本发明将显得更加明确,在附图中:
图1表示了中央腹疝或腹部破裂的截面,
图2是在外科医生执行腹切口并且移除疝囊之后图1中的疝的简化图,
图3是用于本发明的修复体的网格的一个实施例的俯视图,
图4是用于本发明的修复体的加强构件的俯视图,
图5是本发明的修复体的舌状物的俯视图,
图6是本发明的修复体的网格和加强构件的俯视图,
图7A是本发明的修复体的网格、加强构件以及舌状物的俯视图,
图7B是在安装了第二舌状物时图7A的修复体的视图,
图8A是本发明的修复体的俯视图,
图8B是本发明的修复体的变形例的立体图,
图9是将来自图8B的修复体引入到疝缺损中的简化的截面图,
图10A是在将来自图8B的修复体在种植部位处展开后定位的简化的截面图,
图10B是来自图8B的修复体的固定的简化截面图,
图11是在外科医生刚要闭合腹切口之前、被固定到生物组织时的来自图8B的修复体的截面图,
图12是带有两个舌状物的本发明的修复体的实施例的俯视图,
图13是使用来自图12的舌状物的本发明的修复体的放置的简化的截面图,
图14-图17是示出用于制造本发明的修复体的方法的连续步骤的俯视图,其中该修复体包括具有同样的机械性能的四个织物加宽部。
具体实施方式
图1表示腹壁101的疝缺损100,疝缺损100的特征是破坏直肌103周围的腱膜102的连续性以及穿过腹膜104的通道形成了囊(疝囊105,其包含脂肪(网膜)或部分内脏106),并且囊随后挤压在脂肪组织107上并与皮肤108齐平。疝缺损100的一种治疗需承受在腹腔109中更换并保留内脏106。
图2示出了在外科医生在皮肤108、腹壁101以及腹膜104中制造切口并且减小了疝囊之后的来自图1的疝缺损100。在图2中未示出内脏:它们已经被推回腹腔109中。现在外科医生需在例如借助于缝合来闭合切口110之前,经由已做出的切口110将用于加强腹壁的修复体引入到腹腔109中。在脐疝的情形下,切口110的尺寸尤其小,例如1cm至4cm数量级的直径。
图3表示出可与来自图4的加强构件和诸如来自图5的舌状物一起使用的圆盘形状的网格1,以制造本发明的修复体。
网格1由生物相容的线通过针织的、编织的或无纺织的布置而制成。网格1可以是可生物吸收的、部分可生物吸收的或者不吸收的。网格通常是透孔织物,其包括了使组织融合更好的气孔。该网格1是足够柔性的,以便在修复体经由切口110被引入至腹腔109中时被折叠。然而,网格通常是不具有如下弹性的织物,所述弹性能够使网格被折叠起来后,自动恢复到它伸展开的结构。网格1可以由一个织物层或由多个织物层来制造。该织物可以是二维针织物或三维针织物。对于本领域技术人员而言,这种网格是公知的并且这里不更多地详细描述这种网格。网格可以以带的形式被供应,将带切割成待治疗的缺损的尺寸。在所表示的示例中,网格1具有适配于疝缺损100处的切口110的圆盘的形状并且由外围边缘1a定界。在其他实施例中,网格可以是椭圆形。可选地,网格可以是矩形或者正方形。
图4表示出本发明的修复体的加强构件,其适合于来自图3的网格1的形状:就像从图4和图6中显而易见的一样,加强构件具有框架2的形状,框架2大致采用网格1的外围部边缘1a的形状。从而框架2的整体形状是圆环形。框架2设置有两个铰接点3a和3b,在所示出的示例中,铰接点3a和铰接点3b在直径上相对。两个铰接点(3a,3b)使得例如当外科医生施力时,框架2能够被折叠,产生两个整体上同样的部分。优选地,铰接点(3a,3b)本身不具有任何弹性:从而,一旦被折叠成两部分,框架2可以仅通过外力的作用而打开,例如由外科医生施力。
从而框架2包含两个部分,即两个半圆2a和2b,它们通过两个铰接点(3a,3b)连接在一起。如图4所示,半圆2a和半圆2b的各端(2c;2d)是钝的或者圆形的以在植入修复体时防止损伤。在所示示例中,两个半圆2a和2b是对称的:如图6所示,两个铰接点(3a;3b)限定了穿过由框架定界的圆的中心,并且在框架2被固定到网格1时也穿过网格1的中心的中线M。从而即使网格1与框架2一起安装时,网格1可以被折叠成两部分:因此,就像在说明书的其余部分中将变得显而易见的一样,可以折叠修复体。类似地,考虑到框架2为两部分的结构和框架2及它的铰接点(3a,3b)不存在任何的弹性,修复体仅能够采用两种配置:要么是平坦且伸展开的配置,要么是折叠为两个部分的配置。稍后将解释,修复体仅能够采用两种配置的事实便于外科医生的工作,外科医生可以立即确定修复体是否处于其伸展开的配置中。
如图4和图6所示,框架2是从外围部边缘1a缩回的波浪形的环,框架2由波浪4组成。尤其是参考图6,网格的外围部边缘1a延伸为超出框架2的外部轮廓一定距离:例如,该距离可以大于或等于1mm。就像在下文给出的描述中将变得显而易见的一样,框架2的位置从外围部边缘1a略微缩回,这利于尤其在位于网格的中心与其边缘之间的大约中间的区域中,将修复体有效地固定到腹壁上。
框架2的波浪4可以是规则的或不规则的。尤其是,在所示的示例中,框架2是平坦的带形的材料,其在框架2的平面中形成波浪4,框架2的平面大致是修复体的平面。就像在本说明书的其余部分中将变得显而易见的一样,这种形状在框架2的平面上并从而在修复体的平面上给予框架2很大的柔性:因此能够在给定地点处缝合部分修复体,而不使修复体作为整体而摇摆或变形:在缝合位置处产生的变形通过遍布修复体的整个外围的框架2的波浪4而变得平滑。此外,框架2沿其截面表现出刚性,使得其既不在向外的方向上径向变形,也不在向内的方向上径向变形。
适合于制造本发明修复体的加强构件的材料可以是具有一些刚性从而满足以上公开的期望的任何生物相容材料。
框架2从而可以以任何生物相容的材料来制造,而不管该材料是否是可生物吸收或非生物可吸收的材料。在优选实施例中,框架2以可生物吸收材料制成。在本申请中,术语“可生物吸收的”指的是这样的特性:通过这种特性,在给定时间段(取决于该材料的化学性质,例如,该给定时间段可以从一天到数月不等)后,材料由生物组织吸收或降解并且在生物体内消失。
适合于制造本发明的修复体的加强构件的可生物吸收的材料包括聚乳酸(PLA)、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(PHA)、氧化纤维素、聚乙醇酸(PGA)以及这些材料的共聚物及其混合物。适合于制造本发明的修复体的加强构件的可生物吸收的材料包括可由柯惠(Covidien)公司以商标名提供的聚酯(乙交酯、二噁烷酮、三亚甲基碳酸酯)以及商业上可由柯惠公司以商标名提供的聚酯(乙交酯、己内酯、三亚甲基碳酸酯、丙交酯)。
适合于制造本发明的修复体的加强构件的非可生物吸收的材料包括聚丙烯、诸如聚对苯二甲酸乙二醇酯的聚酯、聚酰胺、硅树脂、聚醚醚酮(PEEK)、聚芳基醚酮(PAEK)及其混合物。
本发明的修复体的加强构件的每一部分均可以例如通过一种或更多种生物相容的热塑性材料或热固性材料的注塑成型来以一片的形式制造。框架2的铰接点(3a,3b)可以以与框架的其余部分相同的材料制造:这些铰接点(3a,3b)具有例如材料的非常薄的桥接件的形式,以使框架2能够折叠而不引起通过这些桥接件接合在一起的两个部分分离。
图5示出了适合于本发明的修复体的舌状物5。可以在本图中看到,舌状物5具有整体上的矩形部6和位于矩形部6的一端6a处的加宽部7,该端6a形成在矩形部6与加宽部7之间的联接。在该图中,加宽部7具有梯形的整体形状,其具有圆弧底部7a:如在图7A和图7B中可以看到的,每个舌状物5的加宽部7将会例如借助于框架2固定到网格1。可选地或另外,如图7A中所示,舌状物5的加宽部7可以沿接缝7b被缝到网格上。
如图8B所示,矩形部6的自由端6b可以被接合到其他舌状物5的自由端。在制造修复体期间或者在外科医生植入修复体时,可以接合这些舌状物的自由端6b。从而矩形部6的长度必须足够长以能够接合舌状物5:尽管如此,该长度不能过大以在植入修复体时不妨碍外科医生。矩形部6的长度优选为2cm到6cm并且更优选地为2cm到4cm。
在图5中示出的实施例中,舌状物5以一片的形式制造。与图14-图17有关的在下面描述的其他实施例中,加宽部和矩形部可以是在使用前组装的两个独立的部分。在这样的情形下,两个部分可以是不同的材料。
在下文中将描述,舌状物5可以以任何生物相容材料制造,所述生物相容材料给予了它在安装修复体期间由外科医生捡起该舌状物的所必须的柔性。舌状物5用于帮助外科医生相对于疝定位该修复体并随后将该修复体固定到腹壁。
例如,舌状物5是织物。该织物可以与形成网格1织物相同或不同。在加宽部和矩形部是两个起初为独立的部分的实施例中,加宽部例如可以由如专利文件WO0181667中描述的夹持织物组成并且矩形部可以由粘接至加宽部的透孔织物组成。
舌状物可以由可生物吸收的材料来实现,例如上文描述的用于加强构件的材料。
图8A示出了由来自图3的网格1、来自图4的框架2以及来自图5的四个舌状物所制成的本发明的修复体200。
在未示出的本发明的一个实施例中,本发明的修复体仅具有两个舌状物:在这样的情形下,两个舌状物例如借助于加强构件优选地被固定在折叠线M的任一侧上。
在图8A示出的实施例中,四个舌状物5围绕由框架2形成的环对称布置以互相平衡。特别地,舌状物5中的两个被固定到框架2的两个在直径上相对的位置8和8a,该两个位置均与铰接点3a和3b间隔90°。另外两个舌状物5被固定在两个铰接点3a和3b的位置处。每个舌状物5均通过其加宽部7被固定到网格1上,舌状物5的加宽部的圆弧部成对地邻接。此外,网格1的中心1b还设置有定心线13。在将修复体安装到植入部位上时,该定心线用于由外科医生抓取。定心线13足够长,使得在修复体200在患者体内的情况下,外科医生能够在患者身体的外部操纵该定心线。定心线13和如以上所述规则地分布的四个舌状物5的存在使外科医生能够在定位修复体时平衡在各个舌状物之间的张力并且能够相对于待闭合的缺损更好地对后面的修复体进行定心。
在修复体200的一个实施例中,在所示的示例中的加强构件(即框架2)直接焊接到网格1并且直接焊接到四个舌状物5的圆弧部7a。从而框架2稳固在网格1和舌状物5的加宽部7两者上。修复体200从而大致被包含在一个平面上,该平面包括网格1、框架2以及舌状物5的加宽部7。
在本发明的另一实施例中,如图8B所示,定心线13不是固定到网格1的中心,而是接合四个舌状物5的自由端。该定心线13随后可以由外科医生在植入修复体200之前放置。在该实施例中,定心线13可以穿过舌状物5或者简单地环绕这些舌状物5以将它们保持在一起而不穿过它们。
在图8B的实施例中,网格1的与包含舌状物5的面相反的面被非粘着性的涂层201覆盖。这种非粘着性的涂层尤其能够避免有害的严重的手术后纤维粘着的形成;一旦已经植入了修复体200,修复体200的被非粘着性的涂层201覆盖的面则面向腹腔109。
从可生物吸收的材料、非可生物吸收的材料及其混合物中选择非粘着性的涂层或材料。可以从聚四氟乙烯、聚乙二醇、聚硅氧烷、聚亚安酯及其混合物中选择非可生物吸收的非粘着的材料。
所述非粘着性的涂层或材料优选为可生物吸收的:可以从胶原质、氧化纤维素、聚丙烯酸酯、三亚甲基碳酸酯、己内酯、二噁烷酮、乙醇酸、乳酸、乙交酯、丙交酯、多糖(例如壳聚糖)、聚葡糖醛酸(polyglucuronicacid)、透明质酸、右旋糖苷及其混合物中选择适合于所述非粘着性涂层的可生物吸收的材料。
非粘着性的涂层能够至少在初始疤痕形成阶段期间保护修复体200的网格1,即,网格1不暴露于炎症细胞,炎症细胞例如是通常由手术激发的粒细胞、单核细胞、巨噬细胞或巨多核细胞。至少在初始疤痕形成阶段期间(该阶段的持续时间可以从大约5天到大约10天不等),仅仅非粘着性的涂层易受诸如蛋白质、酶、细胞因子或炎症细胞的不同因素影响。
如果非粘着性的涂层由非可再吸收材料组成,则其在植入前和植入之后并且整个植入修复体200期间保护了网格1。
此外,由于非粘着性的涂层,例如,保护了周围的脆弱组织(诸如中空的内脏)尤其免于形成有害的严重的手术后纤维粘着。
如果非粘着性的材料包括可生物吸收的材料,则优选地,选择在小于若干天中不被再吸收的可生物吸收的材料,以使非粘着性的涂层能够从手术后的这些天中实现保护肠和中空的器官的功能,直到修复体的细胞修复对这些脆弱器官进行保护。
由于加强构件的两个部分,即框架2由所示出的示例中的两个半圆2a和2b组成,半圆2a和半圆2b通过铰接点3a、3b连接在一起,在外科医生将本发明的修复体200沿折叠线M折叠之后,本发明的修复体200可以采用折叠后的配置。从而为了植入修复体200,外科医生将其折叠为两个部分使得其占用更小的体积,这便于外科医生将修复体引入到疝缺损100(见图2)中。
网格1和非粘着性的涂层201足够柔性的以在将修复体200引入到植入部位时遵循修复体200的连续变形。
图14至图17描述了用于制造本发明的修复体210的实施例的方法的各个步骤,本发明的修复体210由图3的网格1、图4的框架2以及与舌状物的矩形部独立制成的四个加宽部207制成。为了清晰性目的,在图14-图17上未示出舌状物的矩形部:这些矩形部类似于图5的舌状物5的矩形部6,并且可以要么与加宽部217成一体,要么通过诸如缝合、焊接、胶接的任何固定方式或借助于夹持织物而附接到所述加宽部217。
在下面的描述中将呈现,修复体210的四个加宽部217沿由框架2形成的环的内部轮廓对称布置,并且它们都具有相同的机械性能。
下面将参考图14-图17来描述这一实施例的制造过程。
参考图14,图14示出了用于形成修复体210(见图17)的舌状物的加宽部217的织物20。在所示的示例中,织物20具有正方形的形状,正方形的一侧长度大于预期产生的修复体210的较大的直径。该织物20可以与形成网格1的织物相同或不同。如图14所示,织物20例如在针织机上制造并且具有经向Wa和纬向We。织物20可以沿其经向Wa和沿其纬向We而具有诸如伸长率和抗张强度的不同的机械性能。
优选地,织物20的颜色与网格1的颜色不同。
为了进行四个加宽部217的制造,在织物20上完成具有十字架形状的切割口21,十字架带有两个垂直分支(22、23),如图15所示,十字架的一个分支22平行于经向Wa并且十字架的另一个分支23平行于纬向We。十字架的分支可以是等长或不等长的。在图15上示出的示例中,平行于经向Wa的分支22的长度小于平行于纬向的分支23的长度。此外,在这个示例中并且从图16中将看出,平行于经向Wa的分支22的长度小于框架2的内周界的直径,而平行于纬向We的分支23的长度大于框架2的外周界的直径。
在进一步的步骤中,将织物20铺设在例如与织物20有相似正方形形状和尺寸的一片网格1上,并且图4的框架2随后被焊接到网格1和织物20两者上。
如图16所示,框架2焊接到网格1和织物20上,使得切割口21的较大的分支23被放置在由框架2(见图4)限定的折叠线M上并且使得切割口21的较大的分支23延伸为超过框架2的铰接点(3a、3b),而切割口21的较小的分支22未达到框架2。这一实施例使得框架2的效率更佳,在该框架2被焊接在网格1和织物20两者上时,所述框架2不会被切割口的分支22产生的残余细丝所损伤。
一旦焊接了框架2,如图17所示,就可以通过将网格1和织物20过多超过框架2的外围部边界的部分切割掉,来制造该圆盘形修复体210。从该图中可以看到,框架2与十字架形状的切割口21一起形成了四个等腰三角形24,四个等腰三角形24通过它们的相应底部24a或多或少被固定到框架2并且四个等腰三角形24在它们的顶角24b处是自由的。织物20的这四个等腰三角形24形成了修复体210的舌状物(未示出)的加宽部217。
就像以上提及的那样,可随后借助于诸如缝合、焊接、胶接的任何固定方式或者借助于夹持织物,将图5的舌状物5的诸如矩形部6的矩形部,依照从每个三角形24的顶角24b绘制的高度24c所限定的方向,附接到每个三角形24的自由顶角24b。
由于该特定的十字架形状的切割口21,其具有平行于经向Wa的一个分支和平行于纬向We的另一个分支,因此,不管事实上织物20在其在经向Wa上的初始伸长性能和抗张强度性能与其在纬向We上的初始伸长性能和抗张强度性能是否相同,在与该圆盘形修复体210的向心方向对应的其高度24c的方向上,织物20的所有四个等腰三角形24都是相同的并且它们均示出相同的机械性能(诸如伸长率和抗张强度)。
事实上,由于在焊接步骤期间切割口21相对于框架2的位置,每个三角形24的高度方向或向心方向形成为相对于该初始的织物20的纬方向和经方向均成45°角。
因此,在与每个三角形24的高度24c方向相对应的方向上,换句话说,在与当外科医生将修复体放置在适当的位置并且将其固定到腹壁时与外科医生所施加的牵引的方向相对应的舌状物(未示出)的矩形部的方向上,所有四个加宽部217示出了相同的机械性能,特别是伸长性能和抗张强度性能。
因此,在外科医生将修复体210放置在适当的位置并且将其固定到腹壁上时拉起四个舌状物的矩形部时,舌状物的所有加宽部217都做出相似的反应并且由外科医生经由四个舌状物在整个修复体上施加的牵引是均等地分布的。因此适当地定位了修复体210。此外,由于织物20的四个等腰三角形24具有与网格1的颜色不同的颜色,因此外科医生容易识别像以上限定的那样的缝合线。从而便于将修复体210固定到腹壁的步骤。
以上描述的制造修复体210的方法是非常简单的,并且允许了从单片织物20开始,用于制造四个加宽部217。
可选地,可以通过初始地准备织物20的四个独立的三角形24并经由框架2将每个三角形24焊接到网格1来制造修复体210,或者可选地,通过准备两片半圆盘的织物20,完成在每个半圆上的垂直切割并且经由框架2将这两个切割的半圆焊接到网格上。
类似于图1-图13的修复体200,图17的修复体210可以设置有定心线13并且可以在网格1的与包含加宽部217的面的相反的面上用非粘着性涂层201进行涂覆。
接下来参考图9至图11来描述本发明修复体(例如来自图8B的修复体200)的安装。尽管未描述,可以以在下文中用于图8B的修复体的方式相同的方式来完成图17的修复体210的安装。
在参考图2描述的制造切口110之后,外科医生抓取来自图8B的修复体200,该修复体200在与包含舌状物5的网格1的面相反的面上覆盖有非粘着性的涂层201,并且外科医生用他的手指对修复体200施力以将其沿折叠线M折叠。由于两个铰接点3a和3b的存在,该操作没有难度并且完全不依赖框架2的本身有无弹性。在所示实施例中,修复体200是圆盘,沿它的其中一条直径而被折叠,产生两个同样的部分。在这种折叠后的配置中,修复体200占用小体积并且在外科医生握住患者体外的定心线13的同时,如图9所示,他可以容易地将修复体200引入到腹腔109中。为了清楚,在图9-图11中未表示出外科医生的手指。
一旦修复体200处于腹腔109中,外科医生就释放在修复体上的压力。是外科医生用手将修复体200展开为完全拉紧的并且伸展开的配置。从而,修复体200能够仅采用两种位置,即折叠为两部分或伸展开,外科医生确信从打开修复体200的一刻起,修复体完全伸展开。
在接下来的步骤中,如图10A所示,外科医生使用定心线13以不仅使修复体200相对于切口110定心,还将抵靠腹壁(101,104)挤压修复体200。为此,外科医生将定心线13拉向患者身体外部。从而完全地伸展修复体200并且处在舌状物5的加宽部7与腹壁(101,104)之间的内脏没有任何风险。
一旦相对于疝缺损正确地定位了修复体200,如图10B所示,外科医生就抽回定心线13,由此释放了舌状物5的自由端6b。
由此,外科医生提起疝的边缘的部分,并因此揭开在修复体200附近的中心区域12,中心区域12总体上由舌状物5的加宽部7定界,外科医生可以容易地看到该区域并且外科医生能够容易地在该区域中工作。在一个实施例中,为了便于外科医生看到中心工作区域12,舌状物5的加宽部7或者整个舌状物5可以与网格1的颜色不同。事实上,舌状物5的加宽部7(或者整个舌状物5)与网格1之间的颜色差异限定了线,该线向外科医生指出完成用于将修复体200固定到腹壁的缝线的地方。该固定路线、或缝合路线整体上与框架2的内部轮廓相对应。
在接下来的步骤中,如图10B所示,外科医生通过使用针9和缝合线10继续将修复体200固定到生物组织以将每个舌状物5的加宽部7缝合到中心工作区域12内的腹壁101、104。在该步骤期间,显著地由于框架2的波浪4的存在,消除了由外科医生在缝合修复体200的过程中引起的修复体200的区域中的变形,因此整个修复体200保持完全伸展开并且完全挤压在腹壁104上。外科医生可以执行用于四个舌状物5的每个加宽部7的一个或更多个缝线(见图11)。
可以从图11中看到,本发明的修复体200的结构使外科医生能够将缝线11放置在位于网格1的中心与其外围部边缘1a之间的区域中;特别是该区域位于框架2的内部轮廓层:从而外科医生不需要在网格1的外围部边缘执行缝线,由于切口110的小尺寸,网格1的外围部边缘很难看到。然而由于框架2的存在,因此网格1保持完全地沿着该围部边缘1a抵靠腹壁104被挤压。尽管如此,由于本发明的修复体200的结构,缝线11有利地处在与缺损有一定距离处,特别是在网格的中心1b(这是疝缺损的位置)和网格的外围部边缘1a之间的大约中间的区域中,在生物组织通常比缺损的边缘处更健康且较不脆弱的地方。缝线11可以例如是U形的,即,通过两端处均设置有针的线获得的。
一旦外科医生在所有加宽部7上执行了必要的缝线11,如图11所示,大致在每个舌状物5的加宽部7与其矩形部6之间的联接6a处切割该舌状物5,以在植入部位处仅保留加宽部7。该图示出了缝线11,缝线11将舌状物5的加宽部7固定到腹壁104。如在图11中可以看到,修复体200因此抵靠腹壁(101,104)完全展开、伸展开并且挤压,而没有在修复体200与腹壁(101,104)之间限制内脏的风险。
外科医生随后仅需要以常规用于小尺寸疝的方式,即,通过缝线,闭合切口110。在该手术期间,由于预先已经有利地切断并移除了舌状物5的矩形部6,因此舌状物5的矩形部6不会妨碍外科医生。
图12示出本发明的修复体的舌状物的实施例的变型例。如图12所示,可以从针织物14的单个矩形片制造两个相反的舌状物5,其中针织物14在其两个端处设置有两个加宽部7。部件14通过如以上说明的用于图1-图11的实施例的加宽部7而被固定到网格1。如果要求最终的修复体设置有四个舌状物,则将垂直于第一片的第二片针织物14固定到网格1。定心线可以穿过两个针织部件14的中心。一旦在植入部位处正确地定位了该修复体,如示出了仅一个针织部件14的图13所示,则外科医生仅需要在每个针织部件14的中心处切割每个针织部件14,从而获得两个相反的舌状物:外科医生可以随后继续固定如图10B和图11所示的修复体。
本发明的修复体的安装特别简单,尽管植入部位的尺寸有限,但是外科医生能够容易地打开舒适的工作区域。本发明的修复体的安装同样特别可靠,避免了限制内脏的所有风险。本发明的修复体特别适合于治疗在所制造的腹切口是小尺寸处的脐疝。本发明的修复体适合于采用这样的配置,该配置中修复体占用特别小的体积以便利于经由小切口将其引入到腹腔中,而不必需使用任何专用辅助设备。由于修复体的特别的结构,本发明的修复体可以有效地伸展开并且挤压在腹部上,同样也不必需使用专用工具以帮助其伸展并且没有任何使修复体反转的风险。从而本发明的修复体能够有效地、简单地并且快速地治疗疝,特别是脐疝,使得复发风险最小化。
Claims (17)
1.修复体(200;210),包括:
-至少一个柔性网格(1),其由外围部边缘(1a)定界,
-至少两个柔性舌状物(5),其从所述网格的一个面延伸出,以及
-至少一个加强构件,其用于加强所述网格,其特征在于,所述加强构件具有框架(2)的形式,所述框架(2)被紧固至所述网格并且大致上采用所述网格的所述外围部边缘的形状,所述框架从所述外围部边缘缩回并且设置有两个铰接点(3a,3b),穿过所述两个铰接点的线也穿过所述网格的中心(1b),并因此形成用于仅通过外力的作用将所述网格折叠成两部分和伸展开的折叠线M。
2.根据权利要求1所述的修复体(200;210),其特征在于,从所述外围部边缘缩回的所述框架(2)是形成波浪(4)的蜿蜒的形状。
3.根据权利要求2所述的修复体(200;210),其特征在于,所述框架(2)具有大致在所述网格的平面上形成波浪(4)的平坦的带的形式。
4.根据权利要求1至3中任一所述的修复体(200;210),其特征在于,所述加强构件由可生物吸收的材料制造。
5.根据权利要求1至3中任一所述的修复体(200;210),其特征在于,所述舌状物(5)具有整体上矩形的形状并且在它们的端部中的一个端部处设置有加宽部(7;217),所述舌状物(5)借助于所述加宽部(7;217)被固定到所述网格。
6.根据权利要求1至3中任一所述的修复体(200),其特征在于,所述舌状物(5)是织物。
7.根据权利要求5所述的修复体(200),其特征在于,所述加宽部(7)与所述舌状物(5)的其余部分分离,所述加宽部(7)由夹持织物制造,使得所述加宽部(7)能够被任意地紧固到和/或脱离于所述舌状物(5)的其余部分。
8.根据权利要求1至3中任一所述的修复体(200),其特征在于,所述两个舌状物(5)被固定到所述折叠线M的任一侧上。
9.根据权利要求8所述的修复体(200),其特征在于,所述两个舌状物(5)被固定到所述折叠线M的任一侧上关于所述折叠线对称的两个位置。
10.根据权利要求1至3中任一所述的修复体(200),其特征在于,所述网格是圆盘形,所述框架大致上为圆环(2)的形式,所述舌状物(5)在所述环(2)的两个在直径上相对的位置(8,8a)被固定,所述两个位置与所述两个铰接点(3a,3b)中的每一个均间隔90°。
11.根据权利要求10所述的修复体(200),其特征在于,包括所述两个舌状物(5)的所述网格的面具有两个附加的舌状物(5),所述两个附加的舌状物(5)在所述环(2)的所述两个铰接点(3a,3b)的位置处被固定到所述网格上。
12.根据权利要求1至3中任一所述的修复体(200),其特征在于,所述网格的与包含所述舌状物(5)的面相反的面覆盖有非粘着性的涂层(201)。
13.根据权利要求1至3中任一所述的修复体(200),其特征在于,所述舌状物(5)的自由端(6b)通过定心线(13)接合在一起。
14.根据权利要求1至3中任一所述的修复体(200;210),其特征在于,所述舌状物(5)的至少一部分的颜色与所述网格(1)的颜色不同。
15.根据权利要求5所述的修复体(200;210),其特征在于,所述舌状物(5)的加宽部(7;217)的颜色与所述网格(1)的颜色不同。
16.根据权利要求15所述的修复体(210),其中所述网格(1)是圆盘形并且所述框架大致上为圆环(2)的形式,所述修复体包括四个所述舌状物,所述舌状物的加宽部(217)的颜色与所述网格的颜色不同,所述四个加宽部沿所述环的内部轮廓相对于所述折叠线M对称地分布,所述加宽部中的两个在所述折叠线M的一侧上,所述加宽部中的另外两个在所述折叠线M的另一侧上。
17.根据权利要求16所述的修复体(210),其中所有四个加宽部都呈现出织物的等腰三角形(24)的形式,每个三角形经由其底部被固定到所述网格,所有四个三角形都表现出在向心方向上的同样的伸长性能和抗张强度性能。
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US20140194926A1 (en) | 2014-07-10 |
CA2841339A1 (en) | 2013-01-17 |
FR2977790B1 (fr) | 2013-07-19 |
CN103764068A (zh) | 2014-04-30 |
EP2731547A1 (en) | 2014-05-21 |
US9622843B2 (en) | 2017-04-18 |
WO2013007534A1 (en) | 2013-01-17 |
AU2012283292B2 (en) | 2016-08-11 |
JP2014523325A (ja) | 2014-09-11 |
JP6049218B2 (ja) | 2016-12-21 |
EP2731547B1 (en) | 2015-07-08 |
AU2012283292A1 (en) | 2014-01-16 |
CA2841339C (en) | 2019-02-12 |
FR2977790A1 (fr) | 2013-01-18 |
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