CN1633263A - 一套治疗妇女尿失禁用的外科器械 - Google Patents

一套治疗妇女尿失禁用的外科器械 Download PDF

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CN1633263A
CN1633263A CNA02815116XA CN02815116A CN1633263A CN 1633263 A CN1633263 A CN 1633263A CN A02815116X A CNA02815116X A CN A02815116XA CN 02815116 A CN02815116 A CN 02815116A CN 1633263 A CN1633263 A CN 1633263A
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urethra
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CN100435753C (zh
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G·W·卡默
H·-J·赫普夫纳
S·兰格雷伯
B·卢斯科姆
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Johnson and Johnson Medical SAS
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Abstract

本发明描述一种用于治疗妇女压力性尿失禁的外科器械。该器械包括:一个第一弯曲针元件(10),该弯曲针元件(10)部分地由一个弯曲的轴确定,该弯曲轴具有一个远端及一个近端;一个植入妇女下腹部内以支撑尿道用的网状物(12);一个第二弯曲针元件(110),该弯曲针元件(110)具有一个近端及一个远端;一个耦合件(112),其用途为同时与第一针(10)的远端和第二针(110)的远端相连接。

Description

一套治疗妇女尿失禁用的 外科器械
交叉参照的相关专利申请
本发明为2000年3月9日提出申请的共待审理的美国专利申请序列号09/521,801的部分继续部分,该项专利申请要求享有1999年6月9日提出申请的美国临时专利申请序列号60/138,231的权利,这里并入该两项专利申请的全部内容以作参考。
技术领域
本发明总体上涉及一种用来治疗妇女尿失禁的外科器械及方法,本发明具体地涉及一种用来在尿道下方建立一个吊带的针及网状物的构造。
背景技术
有超过1100万例尿失禁的妇女,而且大多数失禁妇女所患的是压力性尿失禁(SUI)。患压力性尿失禁的妇女在诸如笑、咳嗽、打喷嚏、正常锻炼等普通的日常活动及运动时会不自觉地发生遗尿。
SUI可以是由于连接在阴道壁和骨盆肌肉及耻骨之间的组织或韧带的功能缺陷所造成。其原因通常包括骨盆肌肉的重复紧张、分娩、骨盆肌肉张力缺失、雌激素缺乏等,这种缺陷导致尿道的功能不正常。和其他类型的失禁不同,SUI不是膀胱的问题。
在正常情况下,尿道在强有力的骨盆底部肌肉及健康的连接组织的支承下能够维持紧密的密封性来阻止不自觉的遗尿。然而,当一个妇女患有最常见形式的SUI时,无力的肌肉及骨盆组织便不能合适地将尿道支承在正确位置上,结果,在作正常的运动时,当压力从膈膜作用到膀胱上时,尿道就不能保持密封而允许尿液漏出。由于SUI既是令人难堪的又是不可预见的,因此许多患有SUI的妇女都逃避积极的生活方式并且避开社交场合。
美国专利5,112,344中描述了一种用来治疗妇女失禁的方法和器具。这种用来将一种线状元件布入体内的外科器械包括一个在其一端有手柄的管状杆和可弯曲的针,该针可滑动地装入杆中,适合在一端接纳线状元件。治疗妇女失禁的方法包括:在阴道壁和前腹壁内的腹直肌鞘之间设置一个环绕尿道的环形的线状元件,从而使其穿过尿道的每一侧;拉紧该线状元件环以使阴道壁及尿道位于正确的相对于耻骨的空间位置上并允许在阴道壁及腹部耻骨联合的前壁之间发展瘢痕组织;以及拆除该线状元件。
美国专利5,899,909公开了一种外科器械,该器械包括一个轴,该轴的一端具有手柄,另一端具有用来先后安装两个弯曲针形状元件(一次安装一个)的连接装置,该弯曲针形状元件的一端和待植入体内的网状物的一端相连。实施手术时,网状物的一端首先通过阴道从尿道的一侧进入体内,然后网状物的另一端通过阴道从尿道的另一侧进入体内,从而形成一个位于尿道和阴道壁之间的围绕尿道的环圈。该网状物延伸在耻骨的上方并穿过腹壁并被拉紧。网状物的两个端头从腹壁处切断而剩余的网状物则植入在体内。这种通过阴道进行的操作的典型产品为Gynecare franchise of Ethicon Inc.,a Johnson&Johnson Company,of Somerville,NJ,USA出售的TVT。在该操作中,两个5毫米的针使一个PROLENE网状物通过阴道并穿过腹部以形成一个围绕尿道中部的无张力的支承。这里并入美国专利5,899,909的全部内容以作参考。
一个治疗SUI的替代方法为悬带方法。在该方法中,首先将一个针或其他的缝合线回取器件通过腹壁插入到耻骨的上方。然后该针便被导向耻骨的后方并穿过围绕尿道的耻骨弓上的筋膜,并通过阴道前壁上的一个切口到达体外。此时,将缝合线连接到针上再拖回针,以使缝合线穿过腹腔。在腹腔中缝合线被固定在直肌上。
在这类操作中,为了防止刺破内部构造的技术包括腹腔镜方法,因此要在腹部制作一个切口用来插入一个视频观察器来观察针穿过腹腔的过程。对患者来说,这些附加的切口不是最佳的。另外,这个穿过腹部的针只能设计成用来截获缝合线而不能截获网状物,该缝合线则事先连接在网状物或所收集的筋膜上。这种针的直径范围通常为从约0.090英寸到约0.120英寸,所以针穿过筋膜时并不形成一个较大的通道,所形成的通道的大小仅够通过缝合线。缝合线并不具有PROLENE网状物那样的可伸长性,因而不能象TVT那样提供无张力的支承。此外,直接将网状物连接在针上也不是最佳的,因为要将网状物拖过针所造成的狭窄通道即便不是不可能也是非常困难的。
因此提供一种用来将网状物植入妇女体内以防止失禁的外科系统将是有益的,这种网状物既可以通过阴道植入也可以通过腹部植入。
本发明满足了这种需求,并克服了先前技术中的一些缺点。
发明内容
本发明克服了先前技术中的一些缺点并提供了用于治疗妇女压力性尿失禁的外科器械及方法。本发明所提供的外科器械的一端上包括一个手柄,其另一端上包括用来先后安装两个弯曲针形状元件(一次安装一个)的连接装置,每个弯曲针形状元件具有一个钝头,每个弯曲针形状元件的直径可以是不变的或是可变的。针的远端包括一个内部锁定的耦合装置,其用途为接纳一个导向针或是接纳一个网状物。
在一个实施例中,每个弯曲针的近端和待植入体内的网状物的独立的端头相连。一个构造上类似于Stamey针的导向针穿过腹部在耻骨后方,沿着尿道的一侧到达位于阴道前壁处的切口。当导向针通过阴道从体内露出后便将其连接到弯曲针的远端上。然后推回弯曲针,使其通过阴道及筋膜沿着导向针原先的路径前进。弯曲针及网状物的第一端头便通过耻骨的上方穿出腹壁。然后再次将导向针插入腹壁通过耻骨后方,沿着尿道的另一侧到达位于阴道前壁处的切口,并将其再次连接到第二弯曲针的远端上,然后推回第二弯曲针,使其通过阴道及筋膜沿着导向针产生的第二次路径前进。网状物的第二端头便通过耻骨的上方穿出腹壁。再从腹壁处将网状物的两个端头切断,网状物的其余部分则留在体内,并在阴道壁和尿道中部之间形成一个无张力的支承物。
在一个备选实施例中,弯曲针穿过腹部而到达耻骨后方,沿着尿道的一侧到达位于阴道前壁上的一个切口处。在弯曲针通过阴道露出体外后,将待植入体内的网状物的一端连接到该弯曲针的远端上。然后,将弯曲针通过阴道并透过筋膜沿着其原先的路径拖回。于是,弯曲针及网状物的第一端便通过耻骨上方并穿过腹壁而到达体外。然后将网状物的第一端从弯曲针上解脱下来,并将弯曲针再次刺入腹部并通过耻骨后方,沿着尿道的另一侧到达位于阴道前壁处的切口。再将网状物的第二端连接到该弯曲针上,然后将弯曲针通过阴道并透过筋膜沿着其第二次形成的路径拖回。于是,网状物的第二端便延伸在耻骨上方并穿过腹壁。再从腹壁处将网状物的两个端头切断,网状物的其余部分则留在体内,并在阴道壁和尿道中部之间形成一个无张力的支承。
本发明同样可以使用在如美国专利5,899,909所述的通过阴道的方法中。
本发明的目的为提供一种外科器械,该器械用来将一种治疗SUI的网状物植入体内,该器械可以适用在通过阴道植入或通过腹部植入的操作中。
本发明的一个优点为能够适应根据优选的外科手术方法而决定的不同的医学特性。
下面通过结合附图的详细描述将能更清楚地了解本发明的这些特点及其他特点及优点,附图以举例的形式阐述本发明的原理。
附图说明
图1所示为本发明的一个实施例的针的侧视图。
图2a为两个针以及与这两个针相连的一个网状物的侧视图。
图2b到图2d为网状物及网状物和针之间的连接装置的几个备选实施例。
图3a所示为两个针和一个连接器的组装图。
图3b到图3d所示为图3a中的连接器的几个备选实施例。
图4a到图4j所示为根据本发明使用两个针及一个导向针以通过腹部的方法来治疗SUI的几个外科步骤。
图5a到图5d所示为将导向针连接到两个针上的几个备选实施例。
图6a到图6h所示为根据本发明的一个备选实施例使用一个针以通过腹部的方法来治疗SUI的几个外科步骤。
图7a到图7g所示是针和网状物之间的连接装置的几个备选实施例。
图8a到图8i所示为根据本发明使用两个针及两个导向针以通过腹部的方法来治疗SUI的几个外科手术步骤。
具体实施方式
在对本发明进行详细描述之前应当指出,下面的描述及附图所示的详细构造及各个零件的配置情况不是对本发明的限定,因为所示的本发明的实施例可以在其他的实施例,变型和修改中得以实现或并入其中,并且可以通过不同的途径来实施或执行。
本发明公开一种用来治疗SUI的器具和方法,将一个网状物或条带穿过骨盆组织并定位在尿道和阴道壁之间而形成一个支承吊带。该网状物提供了一个用于组织向内生长的结构装置,因而为尿道提供一个新生成的身体组织支承手段。当患者的下腹部诸如在咳嗽或喷嚏中受到压力时,该网状物对尿道提供了支承,使得尿道能够保持密封而可防止尿液的意外排出。
在图1及图2a所示的本发明的一个实施例中,该外科器械包括一个针形元件10,该元件10与一个网状物12相连。针形元件10弯成一定半径R的圆弧,以实施在此讨论的外科手术操作。针形元件10的远端以一个锥段14来终止,锥段14具有一个顶端16。备选的构形,诸如叶片形、箭头形或三角凿刀形的顶端也可以使用。优选的顶端16是一个半径约0.6毫米的钝头体。之所以优选为钝头体顶端是因为在下述的网状物植入方法中,这种顶端较少可能卡在骨上或刺破膀胱壁或血管壁组织。
针10的近端终止于一个连接段20,连接段20适于和一个如美国专利5,899,909所述的手柄21匹配并锁定在该手柄21上。
位于锥段14和连接段20之间的是一个弯曲轴段18,该弯曲轴段18包括一个远端17及一个近端19。轴段18的形状基本上是一个四分之一圆的弧段,这个形状和阴道与腹壁之间的耻骨的轮廓基本相吻合。为了下面还将详细讨论的植入方法,轴段18的弯曲半径R优选为约106毫米。轴段18的直径可以是恒定的,例如,约5毫米。备选的是,轴段18的直径可以是从远端17处的较小直径逐渐过渡到近端19处的较大直径。由于远端17处的应力最小,因此该处的最小直径可以小到0.5毫米。近端19处的最小直径为约4毫米。
针10最好是一个圆形截面的管子,并且用与人体相容的材料制造。优选的是,针10用AISI 303不锈钢制造。为了便于刺穿软组织,轴18的表面可以是光滑的,最好是经过抛光的。备选的是,针10的表面可以有一些粗糙表面。粗糙表面会使组织稍受创伤,从而在网状物12周围刺激成纤维细胞的活性。针10的表面还可以是暗色调或暗颜色的,以便于针10在膀胱镜下进行体内定位时具有高的可见度。
针10可以制成为一个连续的单体,或者备选的是,也可以将针10中的弯曲部分18与直线部分20分开制造,此时,两个零件可以用诸如螺纹或本领域技术人员公知的其他任何常规的连接手段来连接。
在图2a到图2d中,网状物12包括任何组织相容的合成材料或任何天然材料,该天然材料包括但不限于:自体的、同种异体的、异种的、组织工程基质材料或这些材料的组合物。一种典型的合成材料为Ethicon,Inc.,Somerville,New Jersey,USA制造的PROLENE聚丙烯网状物,该网状物的厚度为0.7毫米,网眼的开口为约1毫米。这种材料被美国食品及药物管理局核准用于植入人体内。网状物12的另一个实施例为合成材料11和天然材料13的组合物,其中一片天然材料13位于两片合成材料11的中央如图2b及图2c所示。网状物12的另一个实施例包括一种合成材料11和天然材料13的组合物,其中天然材料基本上位于合成材料11的中央部位之上,或是并入在合成材料11的中央部位之中。这种构造的网状物的一个优点是:由于天然材料13设置在网状物12的中央部位,当植入到体内后天然材料13定位在尿道下,消除尿道和网状物的交界面上可能的糜烂组织。天然材料13可以用缝合、生物相容胶、细胞培养技术或其他公知的手段连接到合成材料11上。
网状物12可以采用任何常规的适于达到本发明预期目的的形状。网状物12的典型宽度为约1厘米,其长度取决于经受手术的妇女的身体尺寸。网状物12可以是单层的或是双层的。网状物12一般采用平面构造,或可采用管形构造(见图2d)以获得附加的支承强度并提供更多的表面积来让组织纤维贴附。另外,网状物12可以由不同类型的材料诸如生物可吸收材料和非生物可吸收材料构成。网状物12上还可以包覆有抗微生物添加剂来防止或减少感染。网状物12上还可以设有一层光滑的包覆层,例如一种生物可吸收的水凝胶,以便于网状物穿过组织,如下所述。优选的是,网状物12如美国专利5,899,909所述那样包覆了一层可揭去的塑料外层。网状物12还可以用射线不可透过的材料和/或和体内组织可明显区分的颜色的材料制造,以允许今后诊断的显影。
在一个实施例中,网状物12用捆绑、粘结、或其他适用的连接手段连接到针的连接段20上。优选的是,网状物12用一种生物相容的热缩管固定到针的连接段20上,如图2a所示。
图3a所示为用于连接导向针110及耦合件112的针10的情况。导向针110可以设计成具有和针10相近的弯曲半径R。优选的是,导向针110具有较小的直径,约2毫米。然而,导向针110也可以具有和针10相同的直径。耦合件112的作用是作为一个中介元件用来将导向针110连接到针10上。耦合件112的形状基本上是椭圆形,有一个用来接纳远端17的第一开孔114和一个用来接纳导向针110的远端的第二开孔116。优选的是,开孔116及114设计成以压力配合来与分别与导向针110及针10相连接。备选的是,开孔114及116中可以包括一种生物相容胶或高摩擦材料,以便增强耦合件112和两个针10/110之间的连接。耦合件10可以用任何生物相容的金属(诸如不锈钢)、聚氨酯、硅树脂、橡胶或其他的相似材料来制造。
图3b到图3d所示为一个备选的连接装置,该连接装置用一种诸如Tygon的高摩擦管170制成。图3b中的管子的外径恒定但其内径是变化的,其内径较大的一端用来接纳针10,而内径较小的一端用来接纳导向针110。图3c所示的管172的内径和外径都是变化的。当将针放入管内时,逐渐缩小的内径压在相应针的远端周围,高摩擦系数便使针牢固地固定住。图3d所示为针在管172内的情况。优选的是,管170及172逐渐变细以消除突然变化的表面。在针被拖过腹腔时,这种突然变化的表面会额外地增加拖力。
图4a到图4j所示为使用两个针通过腹部植入网状物12的外科手术方法。图中展示了妇女下腹部的相关部位的构造,图中阴道为50、子宫为52、尿道为54、耻骨为56、存尿的膀胱为58、腹壁为60。导向针110刺破位于耻骨56前方的腹壁60,循着耻骨56的轮廓到达尿道54的一侧,并通过事先制作在阴道50前壁上的切口露出体外,如图4a所示。再将耦合件112连接到露出体外的导向针110的远端上及针10a上,如图4b所示。图中网状物12的一端连接在针10a的近端上。然后,外科医生使导向针110后退通过腹部,并使针10a通过阴道切口依循导向针110造成的相同路径前进,如图4c所示。针10a穿过阴道壁并通过尿道54一侧的软组织,然后如图4d所示那样通过耻骨56后方附近,再穿过脂肪、肌肉、筋膜各层,然后在耻骨56上方处穿出腹壁60。然后,外科医生从针10a上卸下手柄21,并从腹壁60处将针10a拖出体外,如图4e所示。
外科医生从针10a上卸下导向针110,并重复同样操作使导向针110通过尿道54的相对侧并用针10b将网状物12植入到阴道壁和尿道中部处,如图4f到图4j所示。从而完成网状物的植入操作。
图8a到图8i所示为一个备选的优选实施例。将第一导向针110a刺破位于耻骨56前方的腹壁60,循着耻骨56的轮廓到达尿道54的一侧,并通过事先制作在阴道50前壁上的切口而露出体外;将第二导向针110b象第一导向针110a那样刺破位于耻骨56前方的腹壁60,循着耻骨56的轮廓到达尿道54的对侧,并通过事先制作在阴道50前壁上的切口而露出体外,如图8a所示。这时,外科医生可以通过一个膀胱镜来确认膀胱58的完整性。然后,将两个耦合件112a,b分别连接到两个针10a,b的远端上。然后将其近端上连有网状物12的一个端头的针10a通过耦合件112a连到导向针110a上,如图8b所示。然后,外科医生使导向针110a后退通过腹部,并使针10a通过阴道切口依循导向针110a形成的相同路径前进。针穿过阴道壁并通过尿道54一侧的软组织,然后通过耻骨56后方附近,再穿过脂肪、肌肉、筋膜各层,然后在耻骨56上方穿出腹壁60,如图8c到图8d所示。然后,外科医生从针10a上卸下手柄21,并从腹壁60处将针10a拖出体外,如图8e所示。
外科医生重复同样操作,不同的只是退出导向针110b并驱使针10b通过尿道54的相对侧将网状物12植入到阴道壁和尿道中部处,如图8f到图8i所示。从而完成网状物的植入。
图5a到图5d所示的备选实施例用于将针10连接到导向针110上,并如上所述那样通过腹部来植入一个网状物12。在图5a及图5b中,针10的远端改为包括一个开孔118,该开孔118可以压接式连接导向针110的远端。备选的是,开孔118可以包括诸如胶或高摩擦材料等其他的连接手段。
图5c中,针10的远端改为包括一个开孔120及一个锁销122。导向针110改为包括一个L形沟槽124。导向针110的远端插入到开孔120中,而沟槽124与锁销122相啮合并且扭转1/4圈后锁定在那里。图5d所示为一个导向针110中的一个开孔126,该开孔126用来接受针10远端上的一个突出元件128,该突出元件128以压接入开孔126。
图3所示的实施例的一个优点为针10既可以用于通过腹部植入的操作又可以用于通过阴道植入的操作。在这一方法中,一个包括连接在一个网状物12上的两个针10、至少一个耦合件、以及至少一个导向针的成套器械可满足多个外科专家的使用要求。例如,一位妇科专家可能喜欢采用通过阴道植入的方法而可以不用该成套器械中的耦合件及导向针,而一位泌尿科专家则可能喜欢采用通过腹部植入的方法而可以利用该成套器械中的一个或多个耦合件及导向针。
图6a到图6h所示为本发明的一个备选实施例,该实施例用针10刺透腹壁60并和网状物12相连接。在该实施例中,网状物12改成包括一个用来和针10的远端相连的连接装置。该连接装置优选为采用可拆开的连接方式,所以当网状物的端头拖出腹壁后便可和针脱开连接,这时该针便可再次用来回拖网状物的另一端。该实施例允许只使用一枚针来完成植入操作。该实施例还允许使用至少部分地带有天然材料的网状物。带有天然材料的网状物不适用于网状物预先固定在针上的实施例,因为天然材料在较长的库存期内不能够存活。
将远端上带有耦合装置的针10刺入耻骨56前方的腹壁60,如图6a所示,再循着耻骨56的轮廓到达尿道54的一侧,并通过事先制作在阴道50前壁上的切口而露出体外,如图6b所示。通过耦合装置将网状物12的第一端连接到针10的远端上。然后,外科医生使针10后退并依循其原先形成的相同路径通过盆腔,网状物12也同时跟随着针前进,如图4c所示。针10及网状物12穿过阴道并通过尿道54一侧的软组织。然后针及网状物如图4f所示那样通过耻骨56后方附近,并通过脂肪、肌肉及筋膜层,再穿过耻骨56上方的腹壁60而穿出体外。
从网状物的第一端上拆下针10。外科医生重复进行相同的操作,不同的只是这一次针10从尿道54的相对侧通过,如图6d到图6h所示,以将网状物12植入到阴道壁和尿道中部处。
图7a到图7g所示为针10和网状物12之间的连接装置的几个备选实施例。图7a及图7b展示的耦合件130包括一个近端132及一个远端134,近端132用来接纳网状物12,远端134用来接纳针10的远端17。针10的远端17包括一个用来与耦合件130可拆地连接的连接槽120。耦合件130还包括两个弹簧片136、138,这两个弹簧片上分别带有用来与连接槽120接合的指状物140、142。网状物12优选为用生物相容胶或其他适用的机械固定装置连接在远端132上。外科医生可以通过按压弹簧片136、138来迫使指状物140、142抬起,这使得针10的远端17可以滑进或滑出耦合件130,从而简单地将针10接到耦合件130上或从耦合件130上拆下。指状物140、142与连接槽120的啮合使得针10牢固地连接在耦合件130之中。
图7c到图7e所示为一个耦合机械装置150,该耦合机械装置150功能上和保险销相似。弹簧臂152与针10的远端17上的小孔154相连接。
图7f和图7g所示为一个连在网状物12上的环形耦合机械装置160,环的用途为和连接槽120相啮合。
正如本专业的技术人员所知,还存在许多可以用来将网状物可拆地连接到针上的连接装置。
由于整个操作可以在局部麻醉的情况下实施,在网状物12到位后患者能够向外科医生提供反馈信号。通常,膀胱58内要通过导尿管充满诸如水等流体并要求患者进行咳嗽,外科医生能够据此判断尿道的工作情况。如果需要,外科医生可以通过调整位于腹壁60外侧的网状物12的两端来调节其位置,如图4h及图5h所示。调好以后,剪除位于腹壁外的多余的网状物,并将网状物的端头固定在腹内并封闭腹部。同样,封闭阴道壁上的切口,借助于组织片将网状物密封在尿道54和阴道壁50之间。
网状物12留在体内并连接在腹壁上形成一个人造的吊带,该吊带给尿道提供支承,该支承是尿道为了恢复患者对尿的节制所需要的。
显然,尽管上面已经对本发明的许多具体形式作了图示和叙述,在不违背本发明的精神和不越出本发明的范围的情况下仍可对这些实施例作出许多修改。因此这里指出,以上内容不对本发明的范围构成限制。本发明的范围将由所附的权利要求书来限定。

Claims (2)

1.一种用于治疗妇女压力性尿失禁的外科器械,该器械包括:
(a)一网状物,该网状物用于植入妇女的下腹部以对尿道提供支承;
(b)一第一弯曲针元件,该弯曲针元件部分地由一个弯曲轴限定,该弯曲轴具有一个远端及一个近端,该近端上具有用来连接网状物的装置;
(c)一第二弯曲针元件,该弯曲针元件具有一个近端及一个远端;以及
(d)用于同时连接所述第一针的远端和所述第二针的远端的耦合装置。
2.一种用于治疗妇女压力性尿失禁的外科器械,该器械包括:
(a)一网状物,该网状物用于植入妇女的下腹部以对尿道提供支承,该网状物的每个端头上包括一第一耦合装置;以及
(b)一个弯曲针元件,该弯曲针元件部分地由一个弯曲轴限定,该弯曲轴具有一个远端及一个近端,该远端上具有用来连接所述第一耦合装置的第二耦合装置。
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PT1399088E (pt) 2008-07-08
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CN101099686A (zh) 2008-01-09
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US7121997B2 (en) 2006-10-17
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JP4242271B2 (ja) 2009-03-25
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DE60226866D1 (de) 2008-07-10
CA2449474A1 (en) 2002-12-12
CN100435753C (zh) 2008-11-26
US20030023138A1 (en) 2003-01-30
DK1399088T3 (da) 2008-08-18
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ATE396665T1 (de) 2008-06-15
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US6908425B2 (en) 2005-06-21
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