CN1466438A - 实现内腔胃底折叠的方法和在该方法中使用的装置 - Google Patents
实现内腔胃底折叠的方法和在该方法中使用的装置 Download PDFInfo
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Abstract
公开了一种实现内腔胃底折叠的方法和装置。通过食道将一个装置插入病人胃内,该装置包括适于抓取食管连接部并将其拉入胃内的部件和适于向着食道移动一部分胃底的部件。该装置还能放置多个固定件以便将胃壁和食道壁可靠固定在一起。使用胶粘化合物稳定两壁的连接点。
Description
技术领域
本发明通常涉及将胃套叠在食道上的胃底折叠(fundoplicating)技术。本发明特别涉及以内腔的方式实现该胃底折叠的方法和用于将胃底可靠固定于食道的装置。
背景技术
胃底折叠是一种外科手术方法,通常用于治疗胃食管逆流(GER)情况,这是一种由胃食管连接部(GEJ)畸形和/或机能不良的下食道括约肌(LES)造成的疾病。一般与GER有关的一个症状是胃中的内容物回流或逆流到食管。胃底折叠方法用于操作食管组织或胃组织以便在GEJ形成阀而限制向食管的逆流。阀是这样形成的,即通过操作食管并将其套入胃内,接着绕食管末端卷绕胃底并使胃固定在该卷绕位置。
最普通的胃底折叠方法要求切开腹部和胸部,通过该切口实现腹部包绕和固定。由于该外科手术的侵染性高,在大多数病例中发生并发症和发病。此外,这些方法需要的时间长,经常要花费数小时,并在切口处留下伤疤。
其他最近研发的胃底折叠方法通过利用腹腔镜口或经皮肤的内窥镜胃造口手术而在某种程度上避免了大外科手术切口(见US5403326和US5088979,其内容被并入作为参考)。尽管这些方法比起那些造成大腹部和胸部切口的手术方法来有较小侵染性,但是它们还是有侵染性的,而且这样侵染性外科手术的费用高并且危险性大。例如,在这些手术方法中一般要进行全身麻醉,增加了这些手术方法的费用并且要冒着众所周知的危险。
除了由于现有胃底折叠方法的侵染性而带来的复杂性、危险性和高成本之外,这些方法还具有一些其它问题。其中一个问题就是胃底的展开,也称为胃底卷绕的滑移。这种滑移在使用现有的方法时经常发生,因为现有方法不能足够的固定带有皱襞的胃底。
发明内容
本发明目的在于提供一种用于内腔胃底折叠的方法,其中通常首先采用一个挠性内诊镜在胃食管连接部定位连接位点。接着将组织抓取器安置在内诊镜的末端,并连接到位于所述被定位的连接位点处的体组织上。接着将组织移置器安置在内疹镜末端并用于移置胃底,以便产生食道在胃腔内的套叠。然后将一个固定件递送器靠近第一需求的固定件递送位置定位,并用来在所述需求的固定件递送位置穿过构成套叠的组织放置第一固定件。第一固定件将第一部分胃底固定在食道上。然后固定件递送器用于在多个其它需求的固定件位置放置其它的固定件,由此围绕食道固定胃底。在一个实施例中,固定件递送器、组织抓取器和组织移置器可以结合在单个部件中。
最后,注射器安置在内诊镜的末端并用于将粘结剂注入形成套叠的组织。例如,粘结剂可以是纤维化固定剂或粘结剂。
在一个实施例中,本发明提供一种用于实现病人食道和胃的内腔胃底折叠的方法,包括步骤:通过将食道的被选择部分拉入胃内并通过向着食道移置胃底部而形成食道在胃内的套叠;放置固定件并使其穿过套叠,所述固定件使形成套叠的食道壁和胃壁保持彼此相邻近;以及在食道壁和胃壁之间注入粘结剂以便粘结套叠。
在另一个实施例中,本发明提供一种用于实现病人食道和胃的内腔胃底折叠的装置,包括:挠性管,具有适于通过食道插入胃内的末端;组织抓取器,设置在挠性管末端,适于抓取食道的被选择部;组织移置器,靠近组织抓取器设置,适于向着食道移动胃底部;砧部,可相对组织移置部枢轴转动,其中组织移置器和砧部以可释放的方式携带固定件的互补部,使得当胃底部向着食道移动时将所述互补部被连接起来。
附图说明
参照附图并通过以下详细说明可以更容易理解本发明,其中:
图1至4示出了本发明一个实施例的内腔胃底折叠方法;
图1是食道末端和上胃壁的横截面视图,其中通过食道将内诊镜插入胃腔内,组织抓取器连接到位于胃食管连接处的位置上;
图2是类似于图1的横截面视图,此外还示出了组织移置器和移置的胃底,从而形成食道进入胃腔的套叠;
图3是类似于图2的横截面视图,此外还示出了组织固定件器和穿过套叠放置的固定件;
图4是食道末端和上胃壁的横截面视图,其中通过食道将内诊镜插入到胃腔内,将两个固定件放置在所述套叠内,将注射器插入所述套叠内;
图5是食道进入胃腔的套叠的横截面视图,通过食道壁和胃壁插入一个下上管;
图6是类似于图5的横截面视图,其中展开了T固定件的末端;
图7是类似于图5的横截面视图,其中下管缩回身体组织内,T固定件的近端和末端均展开;
图8是每端具有T支撑部的T固定件的立体图;
图9是每端具有四个分叉支撑部的固定件的立体图;
图10是每端具有三个分叉支撑部的固定件的立体图;
图11是每端具有六个分叉支撑部的固定件的立体图,其中叉件呈弯曲形;
图12每端具有可膨胀支撑部的固定件的立体图;
图13a是靠近每端处具有可变形部的固定件的纵向视图,固定件处于未变形位置;
图13b是图13a所示固定件的纵向视图,靠近每端的可变形部处于变形位置;
图14是本发明另一实施例固定件的等角视图,包括具有刺钉件的部分和具有配合垫圈的另一部分;
图15a和15b分别是具有一个和两个上管的内诊镜两个实施例的横截面图;
图16a、16b、16c和16d是用于本发明另一实施例固定件展开器的侧视图;以及
图17a至17e是包括胃底折叠器的本发明不同实施例的操作步骤示意图。
具体实施方式
可以采用挠性内诊镜16实施本发明方法,该内诊镜最好装备有组织抓取器18(见图1)、组织移置器22(见图2)、固定件移动器24(见图3)和注射器28(见图4)。内诊镜最好具有可供各种各样器具穿过的一个或多个上鞘管。例如,内诊镜可以装备有穿过上鞘管腔的并能在内诊者控制下延伸到内诊镜末端的组织移置器。此外,内诊镜最好具有供固定件递送器穿过的第二上鞘,还具有在其末端操作的注射器。内诊者能够从内诊镜近端操作内诊镜,包括组织抓取器、组织移置器、固定件递送器和注射器。
在该过程中可以采用不同类型的内诊镜。如果必要的话,具有一个或多个管道的上管可以在内诊镜上向胃底折叠位置滑动,以便插入附加器具。例如,图15a示出了具有几个通道15的内诊镜16,通道15提供冲洗、抽吸、照明和视频反馈。该实施例内诊镜16包括一个工作通道A。为了便于插入附加器具,可以使用上管20,上管形成鞘(sheath),鞘限定了延伸到内诊镜16末端的附加工作通道E和F。同样地,图15b示出了具有两个工作通道A和B的内诊镜16’。在这种情况下,上管20’仅必须为一个附加工作通道F提供通路。在这里,“内诊装置”通常用于指示和内诊,并且在需要时,上管形成附加工作通道。
在一个实施例中,向病人的胃吹气以便进行手术。在该方法中,还采用静脉麻醉注射使病人镇静。
采用本发明方法首先将挠性内诊镜16插入病人嘴里,使其穿过食道10而进入胃里,如图1所示。接着通常使插入的内诊镜16定位在胃食管连接处的附连位点14。实施该方法的内诊者或者其它从业者能够通过内诊镜观察GEJ而定位在该目标位点。通过内诊镜定位目标点的方法已经公知和广泛使用。
组织抓取器18能够定位并结合于定位附连位点14,从而抓握住该组织,如图1所示。组织抓取器18穿过内诊镜16的腔并可由从业者从内诊镜16近端来操作。最好,从业者能够控制抓取器18的结合/脱开,以及控制抓取器18施加在被结合组织上的张力。通过伸出抓取器18或使抓取器18向着内诊镜16末端缩回而控制该张力。组织抓取器18结合或抓握组织的部分可以包括本领域中公知的钩子、夹子、抓取器、其组合物或类似物。
当已经抓住GEJ处的组织后,使用组织移置器22移置胃底12,从而有效地形成食道10在胃32中的套叠30,如图2所示。组织移置器22穿过围绕内诊镜16上管20的腔,并能被推动或旋转到远离内诊镜16末端的位置。移置器22最好包括位于硬缆或镍钛诺带末端的球形端。从业者可以例如通过推动或转动而使其移动到靠着胃底的位置来操作组织移置器22。
组织移置器22一旦处于靠着胃底12的位置,则受到进一步的推动和转动,从而压靠和重新定位胃底12。同时,组织抓取器18抓住附连位点14处的组织,施加与组织移置器22所施加力相反的一个力。这些反作用力的合成效果是使胃底12更靠近食道,形成更小的锐角His角,该角由标号34表示。胃底12的移置形成组织瓣30,有效地使食道10在胃32内套叠。在一个实施例中,组织瓣可以具有大约1至3cm的高度。
在优选实施例中,围绕套叠周围的几个位置处重复用组织抓取器18拉动组织和用组织移置器22移置胃底的步骤。例如,可以在围绕食管圆周的四至十二个等分位置完成该过程。
His角34的减小和套叠的形成降低了胃内容物逆流到食道10的程度。大体上在胃和食道之间形成一个阀。当在胃腔32内或特别是在胃底12内产生气体时,压力施加在食道10的包绕部,将其与胃隔离。此外,胃内容物由于胃肌的收缩和身体的移动而在胃腔12内来回移动。套叠30通过形成象屏障一样的阀来减轻GER,而胃内容物为了到达食道10则必须通过该阀。
接着将套叠的食道30固定在胃底12的壁上以便固定该设置。固定件递送器24用于将固定件26插入套叠30内,以便固定住胃和食道组织。由于多条神经和血管通常经过被固定的组织,因此从业者应该在插入固定件26之前使神经和血管定位,以便不伤害或切断这些神经和血管。特别是,从业者应该使沿着食道侧面延伸的迷走神经、大动脉和各种胃血管定位。本领域中已知有多很种对这样的解剖学特征进行定位的方法,包括超声、荧光镜透视和x射线。
一旦上述特征得到定位,则从业者将固定件26装入固定件递送器24内并插入固定件递送器24而使其穿过第二鞘管25,直到递送器24的操作端位于需求的固定件插入位点为止。接着使用递送器24将固定件放置在需求的位点,如图3所示。固定件26最好插入并穿过新形成组织瓣30顶端14上面1cm和2.5cm处的套叠,顶端14延伸到胃腔32内。还可以在沿着组织瓣长度的其他位置上将固定件26插入,最好具有大约1至3cm的长度。
固定件递送器24可以在食道和胃腔内旋转,以便围绕食道的整个周围插入固定件。最好,以大致30°的间隔插入固定件。例如,递送器24可以由最初的插入位点沿一个方向旋转,在距最初位点30°、60°、120°和180°的位置插入固定件。递送器24接着返回到最初插入位点并沿反方向旋转,再次以30°间隔插入固定件,直到套叠的整个周围得到固定为止。
最好,套叠应该延伸整个360度,即食道的整个周围。通过套叠形成的阀类似于“gerd标准”打开或腹腔镜检法过程,一种Nissen胃底折叠。然而,不可能用内腔方法实现整个360度。在那种情况下,可以实施围绕食道延伸270度的Toupet胃底折叠。因此通常不能在食道后侧的大致60度的弧上实施该内腔方法。可以在食道周围其余部分以30°间隔放置固定件。
图5示出了具有斜边的下管(hypotube)40,下管40已经插入并穿过固定件递送器24并进一步向前移动以便分别刺穿食道壁44和胃壁46。下管40可以为皮下注射针套管或其他类型细管,最好是不锈钢的。
本领域公知的T固定件42可以插入并穿过下管40,直到固定件42的末端在套叠的胃侧部上展开为止。下管40接着向着鞘24收缩,使得当下管40缩回时T固定件的展开末端结合胃壁46,如图6所示。如图7所示,下管40进一步缩入鞘24,直到通过由T固定件42末端施加的拉力将T固定件近端从下管40拔出为止。接着使T固定件42的近端坐靠在食道的内壁上,由此将胃壁和食道夹持在一起。T固定件的纵向中心部的长度决定了食道内壁和胃内壁之间的最大距离。
图9-11示出了可以用于固定食道壁和胃壁的各种T固定件结构。传统的T固定件48每端具有简单的T杆。采用这种固定件,将胃组织和食道组织固定在后变形位置中的力由固定件每端的T杆承受,这些力作用在其所具有的较小面积上。可能通过胃壁或食道壁拉动该类型的T杆。因此,可能需要采用本发明的T固定件,它具有供固定组织的力分布的较大面积。图9示出了每端具有两个T杆支撑部的T固定件。另外,通过利用具有三个分叉、四个分叉或六个分叉的T固定件增大了供固定组织的力分布的面积(分别见图10、9和11)。
图12示出了本发明另一种可以用于固定胃组织和食道组织的固定件56。固定件56每端具有可膨胀球58的纵向中心部。可以以与上述T固定件相同的插入方式,使该固定件56插入并穿过胃组织和食道组织。一旦将固定件56固定住,则可以将空气、水或其他物质导入可膨胀端58,由此使可膨胀端58膨胀并固定胃组织和食道组织。可膨胀端可以为球形或盘形。
在一个实施例中,可以在固定件42末端形成球,如图12所示,并可在通过壁44、46插入时将其存放在下管40内。当下管40缩回时,可以由流过在下管40内形成的膨胀管的液体使球膨胀。在由下管40分离前,可以在固定件42近端进行类似过程而使球膨胀。可以采用公知设计结构的密封来保证两个球都膨胀。
图13-14还示出了本发明用于固定胃组织和食道组织的其他可供选择的固定件60。固定件60是末端和近端具有可变形部62、64的长形件,最好由聚丙烯或其他不会排斥的耐久性材料制成。
可变形部62、62最好具有网状结构,它是通过将固定件60端部向另一端挤压进行挠曲而沿径向张开的结构。如图5-7所示,以与上述关于T固定件插入方式相同的方式,将固定件60插入胃组织和食道组织。当近端和末端分别处于食道和胃内的要求位置时,端部张开。
在一个实施例中,形成固定件60,可以使其通常偏向变形位置,如图13b所示。这种类型的固定件60能够在装入下管40时保持小直径结构,在其释放时,由于自然偏移因此会使其张开。可变形部62和64受到压缩,以便使固定件插入并穿过递送器24以及穿过胃组织和食道组织。固定件60接着向前移动而穿过下管40,直到末端可变形部64伸出下管的末端40为止,从而恢复到其正常的沿径向展开的位置。接着可以收回下管40,使近端可变形部62张开到器正常的沿径向张开的位置。变形部62、64接着起支撑部作用而将胃组织和食道组织固定住。
此外,可以形成具有可变形部60的固定件60,使可变形部通常处于非变形位置,如图13a所示。以与上述正常变形实施例相同的方式将通常非变形的固定件插入并穿过胃组织和食道组织。接着必须操纵正常非变形固定件,使其在被放置到展开食道组织和胃组织的要求位置后处于图13b所示的变形位置。可以使用通过内诊镜的腔插入的卷边器来完成这样的操作。该装置象一个已知用于插入铆钉的机构。如本领域的技术人员所理解的那样,可以使用通过内诊镜腔插入并能压缩固定件60端部以便压弯可变形部的任何装置作为卷边器。
固定件60末端还可以具有有助于插入的针状点。这样的末端可以使固定件60直接插入并穿过胃组织和食道组织,而不需要下管40。
如图16所示,参照图5-7的上述下管40可以由展开固定件102的插入器100代替。如图16a所示,当插入器100处于穿过食道壁和胃壁44、46的位置时,拉动延伸内诊镜16长度的动作线104,使得末端展幅件106展开,如图16b所示。当收回插入器100时,如图16c所示,再次拉动动作线104,使得展开近端展幅件108,壁44、46被夹在展幅件106、108之间,如图16d所示。
在本发明的不同实施例中,可以采用两件型固定件包括刺钉件70和配合垫圈74,如图14所示。刺钉件70包括具有带刺连接件72的盘形部71。插入带刺连接件72而使其穿过配合垫圈74,使得通过垫圈74结合连接件72。两个部件70和74最好由弹性聚合物材料制成。
在本发明装置的另一种可供选择的实施例中,可以采用胃底折叠器120插入刺钉件70和配合垫圈74,如图17a至17e所示。图17a示出了挠性管121端部的胃底折叠器120,通过食道10将其插入病人的胃32内。还可以引入内诊镜16以便通过视觉监视该过程。一旦处于应有位置,胃底折叠器120则展开可枢轴转动的组织移置部124,如图17b所示,向着胃底12移动到适当定位。
胃底折叠器120的夹紧部128用于夹紧附连位点14,如图17c所示,使得胃底折叠器120的下移将食道10的区域拉入胃32内。还可以使用长钉130来促进该过程。一旦食道打开到合适位置,则向着胃底折叠器120的砧部126枢轴转动组织移置部124,以便将胃底12推向着食道而形成套叠。
当组织移置部124到达砧部126时,如图17d所示,安装在组织移置部124上的固定件刺钉部70刺入胃壁46和食道壁44,并固定在安装于砧部126上的配合垫圈74上。该过程形成组织瓣132。如以上本发明其它的实施例所述,可以在围绕食道的不同圆周位置重复该过程,以便形成具有使胃32和食道10分离的需求形状的阀,如图17e所示。
最后,可以将粘结剂注入套叠的组织内,如图4所示,引起纤维化反应,该纤维化反应固定胃底折叠的胃组织和食道组织。例如鱼肝油酸钠(Sodiummorrhuate)是一种已知制剂,可以将其注入形成在胃组织和食道组织之间的组织折,以便产生将胃底永久性粘结于食道的纤维化反应。
可以使用几种化合物作为粘结剂。例如在胶粘化合物中,可以使用氰基丙烯酸盐粘合剂,肌肉粘结蛋白,转化生长因子Beta、醇溶谷蛋白凝胶体、凝胶-雷琐酚-甲醛胶和Hystoacryl。在致组织硬化物质化合物中,可以使用鱼肝油酸钠、十四烷基硫酸钠、乙醇胺油酸盐(酯)、aerosol-tale和消毒硫酸博来霉素。
当使用这样的粘结剂时,固定件仅需固定组织,直到由粘结剂引起的反应足以将组织固定住为止。使用的固定件可以由生物所能分解或吸收的材料制成,或可以将其去除。
Claims (22)
1、一种实现病人食道和胃的内腔胃底折叠的方法,包括:
通过将选择的食道部分拉入胃内并通过向着食道移置胃底部而形成食道在胃内的套叠;
放置固定件并使其穿过套叠,所述固定件保持形成套叠的食道壁和胃壁彼此相靠近;以及
在食道壁和胃壁之间注入粘结剂以便粘结套叠。
2、如权利要求1所述的方法,进一步包括在粘结套叠后去除固定件。
3、如权利要求1所述的方法,进一步包括预备步骤:
通过食道引入内诊镜并使其靠近胃食管连接部定位;
从内诊镜伸出适于抓取并拉动食道开口部的抓取器;以及
从内诊镜伸出适于移置胃底部的组织移置器。
4、如权利要求1所述的方法,进一步包括:
通过食道引入固定件递送器并使其在靠近套叠的需要固定的位置处进行定位;
从递送器递送固定件以便将食道壁与胃壁连接。
5、如权利要求4所述的方法,进一步包括:
从固定件递送器伸出下管而穿过构成套叠的食道壁和胃壁;
展开固定件的末端以防止固定件退回;
从套叠退回下管;以及
展开固定件的近端以保持食道壁接近胃壁。
6、如权利要求4所述的方法,进一步包括的选定次数的重复定位和递送步骤。
7、如权利要求6所述的方法,进一步包括在围绕套叠圆周上选定位置相继地安置递送器。
8、如权利要求5所述的方法,其中展开步骤进一步包括使设置在固定件末端和近端的球膨胀。
9、如权利要求5所述的方法,其中展开步骤进一步包括延伸设置在固定件末端和近端的可变形部。
10、如权利要求1所述的方法,其中注射步骤进一步包括注射至少胶粘剂和致组织硬化物质剂之一。
11、如权利要求1所述的方法,形成套叠和放置固定件的步骤进一步包括:
通过食道引入具有夹紧部和组织移置部的抓取器,并将其靠近胃食管连接部放置;
用夹紧部夹紧食道的开口部,并将开口部拉入胃内;
通过向抓取器的砧部枢轴转动组织移置部而向着食道移动胃底部,使得胃壁和食道壁处于砧部和转动的组织移置部之间;
驱动设置在组织移置部上的固定件刺钉部而使其穿过胃壁和食道壁;以及
将固定件的刺钉部固定于设置在砧部上的固定件配合垫圈部。
12、一种实现内腔胃底折叠的方法,包括步骤:
插入内诊镜,使其通过病人的食道进入病人的胃内;
插入抓取器,使其通过食道到达靠近胃食管连接处的位置;
插入组织移置器,使其通过食道插入靠近胃食管连接处的位置;
用抓取器抓取食道的选择部并将其移入胃内,以便形成食道壁;
用组织移置器向着食道壁移置胃底部,以便形成胃壁;
插入抓取器,使其穿过食道而到达靠近胃食管连接部的位置;以及
从抓取器展开固定件,以便将食道壁连接于胃壁上。
13、如权利要求12所述的方法,进一步包括在食道壁和胃壁之间注入粘结剂和致组织硬化物质剂。
14、如权利要求12所述的方法,进一步包括在内诊镜上插入上管,形成供至少抓取器、组织移置器和固定器之一插入的通道。
15、如权利要求12所述的方法,进一步包括通过有选择地进行旋转而旋转固定器,和重复所述展开步骤。
16、如权利要求15所述的方法,其中旋转步骤包括旋转抓取器大约30度。
17、如权利要求12所述的方法,进一步包括在将胃壁粘结于食道壁后去除固定件。
18、一种完成患者食管和胃的内腔胃底折叠的装置,包括:
挠性管,具有适于通过食道插入胃内的末端;
组织抓取器,设置在挠性管末端,适于抓取食道的被选择部分;
组织移置器,靠近组织抓取器设置,适于向着食道移动胃底部;
砧部,可关于组织移置部枢轴转动,其中组织移置器和砧部以可释放的方式携带固定件的互补部,使得当胃底部向着食道移动时将所述互补部连接。
19、如权利要求18所述的装置,进一步包括适于移动食道的被选择部分的挠性管刺钉部。
20、如权利要求18所述的装置,其中组织抓取器包括一对可独立于组织移置器操作的爪。
21、如权利要求18所述的装置,其中固定件包括刺钉部和配合垫圈部。
22、如权利要求18所述的装置,其中组织移置部和砧部的枢轴转动将食道的被选择部分和被移动的胃底部放置在组织移置器和砧部之间。
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CN103800042B (zh) * | 2008-03-18 | 2016-03-02 | 波士顿科学西美德公司 | 内窥镜钉合装置和方法 |
CN110384569A (zh) * | 2019-07-24 | 2019-10-29 | 苏州大学附属第一医院 | 一种可复性胆管梗阻大鼠模型的制备方法 |
WO2023179576A1 (zh) * | 2022-03-21 | 2023-09-28 | 南微医学科技股份有限公司 | 锚定装置和锚定器械 |
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JP2004528857A (ja) | 2004-09-24 |
CN1303942C (zh) | 2007-03-14 |
AU2001291185B2 (en) | 2006-06-22 |
WO2002028289A1 (en) | 2002-04-11 |
US20040158264A1 (en) | 2004-08-12 |
EP1322232B1 (en) | 2008-04-02 |
US7074229B2 (en) | 2006-07-11 |
AU9118501A (en) | 2002-04-15 |
US20060241662A1 (en) | 2006-10-26 |
DE60133474D1 (de) | 2008-05-15 |
WO2002028289A9 (en) | 2003-11-13 |
CA2423874A1 (en) | 2002-04-11 |
IL154934A (en) | 2009-06-15 |
ZA200302116B (en) | 2005-01-17 |
DE60133474T2 (de) | 2008-11-27 |
US6736828B1 (en) | 2004-05-18 |
CA2423874C (en) | 2009-10-13 |
JP4805527B2 (ja) | 2011-11-02 |
EP1322232A1 (en) | 2003-07-02 |
IL154934A0 (en) | 2003-10-31 |
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