CN1674834A - 可膨胀的经皮套管 - Google Patents
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Abstract
揭示了一种可膨胀的经皮套管(100),用于在处于一较小的第一横剖面积结构时插入身体,随后膨胀至一扩大的第二横剖面结构。由可拆卸的管状限制件(200)将该套管保持在较小的第一横剖面结构中。在一应用中,利用该套管引入在现场形成的矫形固定杆,例如用在脊骨固定手术过程中。
Description
技术领域
本发明涉及医学装置,更具体地涉及形成经皮通道的方法和装置。在一应用中,本发明涉及侵害程度最小的用于将矫形的固定件或稳定植入物插入身体(例如在现场成形的脊骨稳定杆)的手术。
背景技术
脊椎和相关联的连接部分受到引起疼痛和残疾的各种疾病和状态的折磨。在这些疾病和状态中有椎关节强硬、脊椎前移、脊椎不稳定、管狭窄yj变质、突出,或者椎间盘变质和突出。此外,脊椎和相关联的连接部分受到伤害,包括断裂和韧带扭伤以及包括椎板切除术在内的外科处理。
与这些疾病、状态、伤害和处理相关的疼痛和残疾是由于脊椎的全部或部分相对于脊椎柱的其余部分产生了移位。已研发了许多方法将已移位的脊椎或已移位脊椎的部分恢复到它们的正常位置并将它们固定在脊椎柱内。例如,用螺钉固定的切开复位是一种目前使用的方法。用销钉、螺钉、杆和板连接骨的两个或多个部分的外科手术过程要求切入在该骨周围的组织内并钻出穿过所要连接的骨部分钻一个或多个孔。由于骨尺寸、结构和负载要求方面的显著差异,在现有技术中已研制多种多样的骨固定装置。通常,目前标准的护理依赖于各种各样线、螺钉、杆、板和夹具在愈合或融合过程中稳定骨碎片。但是,这些方法存在许多缺点,例如不健全、高成本、病人住医较长时期和与切开操作相关的疼痛。
因此,需要有用于再定位和固定移位的脊椎或已移位脊椎的部分、并引起较少的疼痛和潜在的复杂问题的装置和方法。较佳地,该装置可通过侵害程度最小的手术来植入。
此外,多种多样的诊断的和治疗的过程包括将一装置通过天然的或人工产生的进入通道引入。为这目的研制的进入系统的总目的是使穿刺的横剖面积最小,同时使诊断的或治疗的仪器可用的空间为最大。其中,这些操作包括多种多样的腹腔镜诊断的和治疗的插入操作。因此,仍然需要允许一装置经皮地通过较小直径的组织区域、同时适合于引入较大直径的仪器进入技术。
发明内容
按照本发明的一方面提供了经皮进入套管。在一应用中,使用经皮的进出套管以便于插入在现场形成的矫形固定或稳定植入物(例如脊柱稳定杆)。
可以与在其远端设置有气囊的扩展导管相结合地使用经皮进入套管。经皮进入套管具有近段和可变直径的远段。可以将扩展导管设置在经皮进入套管内,以致气囊位于经皮进入套管的远段内。
由诸如穿孔的插入套管之类的可释放的限制件将经皮进入套管的远段限制在一较小的第一直径中。经皮进入套管的近段起皱、向内折叠并插入该插入套管的远段内。这使经皮进入套管处于较小的横剖面外形之中,便于它的插入。
如以包装地将经皮进入套管插入。插入之后可以沿着插入套管的穿孔撕去插入套管。为了便于此操作可以局部地使这气囊膨胀,膨胀经皮进入套管的远段,以便足以沿着它的穿孔撕开插入套管。在去除插入套管之后,可以全部地膨胀气囊,用于使经皮进入套管的远段扩张至它的最大的横剖面外形。然后,可以使气囊放气,以允许去除扩展导管,将经皮进入套管留在适当位置中。
在使用经皮进入套管以便于插入在现场形成的矫形的脊柱稳定植入物的一实施例中,可以有利地用上述方法首先将经皮进入套管插入通过相邻骨固定件的入口。这提供了光滑的通道,以便于在其远端装有可膨胀的矫形固定装置的另一扩展导管的通过。
经皮进入套管的其它应用包括要求穿过人工产生的或天然的身体的空腔进入身体的内部的多种多样的疹断的治疗的临床情况。
附图简述
图1是经皮进入套管的侧视图。
图2是插入套管的侧视图。
图3示出了在横剖面结构缩小并被插入在插入套管内的经皮进入套管。
图4是进入套管膨胀导管的侧视图。
图5是膨胀导管远端的放大图。
图6是膨胀导管近端的放大图。
图7示出了膨胀导管插入图3所示结构时的经皮进入套管组件。
图8是骨固定件的侧视图。
图9是图8的骨固定件围绕它的纵向轴线转动90°的侧视图。
图10是图9的骨固定件的纵向剖视图。
图11是骨固定件的另一实施例的侧剖视图。
图12-15示出了穿引一引导线通过植入在脊椎柱中的相邻脊椎内的骨固定件的入口的方法的实施例。
具体实施例
图1是经皮进入套管100的总图。它通常包括带有轴向内腔的细长管体,并被设计成提供到达在身体内的疹断的或治疗部位的经皮的进入通道。细长管体具有近段和远段110。如本领域的那些熟练人员参照本揭示内容会理解的那样,这两段的长度可以按照临床的需要而改变。远段110可以从一较小的第一横剖面外形膨胀到一较大的第二横剖面外形。远端110的较小的第一横剖面外形便于它插入经皮的治疗部位。在插入之后,使远段110膨胀到较大的第二横剖面外形,以为外科仪器到达经皮的治疗部位提供较大的通道。
在所示的实施例中,经皮进入套管100由带有内层104和外层106的双层共挤压的管102制成。内层104形成内腔108。内层104较外层106进一步向远端延伸,以致管102的远段110是单层的内层104。内层104可以由聚四氟乙烯制成,外层106可以由高密度聚乙烯制成。对于任何一层也可以使用例如尼龙、PEBAX或PEEK的其它适当的材料。
在这实施例中,远段110从较大的横剖面外形起皱、向内折叠并坍塌至较小的横剖面外形,以便于它的插入。如以下所述,在本发明的一应用中,将远段110插入穿过相邻的接骨螺钉或固定件。从而由这些相邻的接骨螺钉之间的距离确定它长度,通常在4-12厘米之间。管102的近端112向外扩张并装配在手柄114上。可以通过螺纹将远端帽116连接于手柄114,用于固定管102的近端112。此外,可以通过螺纹将近端帽118连接在手柄114上。管子102的整个长度取决于在插入和治疗部位之间的距离,对于脊椎的矫形固定外科手术大体在15-60厘米范围内。在所示的实施例中,该管子的长度约为20厘米,远段110占该长度的约一半。
图2是插入磁管200的总图。它较佳地由薄的、光滑且柔性的材料制成。插入套管200具有近段和远限制段210。该限制段210具有比插入套管200的近段小的横剖面外形。该限制段210适合于将经皮进入套管100的远段110限制在它的较小的横剖面外形中。通过将经皮进入套管100插入该插入套管200,使经皮进入套管100的远段110处在插入套管200的限制段210内,来实现该限制作用。
在所示的实施例中,插入套管200可以由聚四氟乙烯制造。插入套管200的近端202终止于拉接头204,该接头可以由有螺纹的路厄锁定件形成。插入套管200设置有靠近它的近端202的狭缝206。插入套管200在一第一变细位置208渐缩成限制段210,该限制段210再次渐缩地进入远侧末端212。如以上所述,限制段210将经皮进入套管100的远段110限制在其较小的横剖面外形中。因此,限制段210的长度大体与远段110的长度相同或比其稍长,通常在4-13厘米范围之内。
限制段210的直径较佳地小于所使用的接骨螺钉(如以下所述)的孔眼的直径。插入套管200可以穿孔或设置有从第一变细位置208至它的远侧末端212的撕裂线。在狭缝206和远侧末端212之间的距离通常大约等于或稍短于管子102的长度,这样大体在12-57厘米的范围内。在所示的实施例中,这距离约15厘米,插入套管200的总长度约24厘米。
图3示出了经皮进入套管100通过插入套管200的近端202附近的狭缝206插入该插入套管200。插入套管200的限制段210的直径小于管102的远段110的直径。远段110起皱和向内折叠,以缩小它的有效直径,并插入限制段210。如以上所述,限制段210将经皮进入套管100的远段110限制在它的较小剖面外形中。限制段210的长度与远段110的长度相同或稍长一些。这样被插入,远段110延伸到达就在插入套管200的远侧末端212附近的位置。
在某些实施例中,如果经皮进入套管100的远段110由可以从较小的第一横剖面外形拉伸至较大的第二横剖面外形的可拉伸的材料制造时,可以不需要插入套管200。在这些实施例中,远段110的外表面较佳地由光滑的材料制造,以便于经皮进入套管100插入治疗部位。
图4是扩展导管300。它在其远端设置有例如气囊310的膨胀部分。将扩展导管100插入经皮进入套管100的内腔108中,以致将气囊310设置在远段110内。在经皮的进套管100插入治疗部位之后,可以使气囊310膨胀,用于使远段110从它的较小的第一横剖面外形膨胀至它的较大的第二横剖面外形。
内管302延伸至扩展导管300的整个长度。在内管302的内部形成引导线内腔304。扩展导管300可以沿着通过引导线内腔304延伸的引导线行进。内管302在它的外部同轴线地带有外管306。内管306在在近端终止在手柄308的远端内,在远端终止在气囊310的近端内。气囊310可以由聚对苯二甲酸乙二醇酯制成。手柄308可以设置有从它的远端延伸并在外管306的近段上的可选用的支持管312,以在插入期间提高扩展导管300的刚度。这支持管312可以用铝制成。
图5是扩展导管300的远端的放大图。内管302和引导线内腔304延伸通过气囊310的远端314。内管302在它的外表面上、靠近气囊310的远端314同轴线地装有标记环316。或者气囊310的远端314可以装有标记环316。标记环316较佳地由金、钛或另一射线不可透过的材料制成。在气囊310内可以设置附加的标记环,以帮助可视它的位置。在内管302和外管306之间的空间内形成的气囊膨胀内腔318与气囊310的内部连通。如以上所述,可以使气囊310膨胀,用于使经皮进入套管100的远段110从它的较小的第一横剖面外形膨胀至它的较大的第二横剖面外形。这样,气囊310的长度大体上等于远段110的长度或比其稍长。在所示的实施例中,气囊310的长度约为10厘米。
图6是扩展导管300的近端的放大图。内管302和引导线内腔304延伸通过手柄308的近端。在内管302和外管306之间的空间内形成的气囊膨胀内腔318通向手柄308内的孔320。止动件322在手柄308内支持内管302,并防止气囊膨胀内腔318与在手柄308的主支路内的空间324连通。这样仅有孔口320通过气囊膨胀内腔318与气囊的内部连通。可以将一泵连接于该孔口320,以膨胀气囊或使其放气。为了能够看见气囊的状态,可以用对比介质膨胀它。
图7示出了经皮进入套管组件150。经皮进入套管组件150包括经皮进入套管100、插入套管200和扩展导管300。通过将扩展导管300插入经皮进入套管100,并将经皮进入套管100例如通过狭缝206或其它靠近插入套管200的近端202设置的其它近端开口插入该插入套管200。使扩展导管300的气囊310放气、折叠并插入进入套管100的远段110。如以上所述,远段110起皱和向内折叠以缩小它的有效直径,并被插入该插入套管200的限制段210内。如以上所述,气囊310的长度大致与远段110和限制段210的长度相同或稍长一点。
图8-11示出了以上所述的骨固定件410的实施例。它设置有在它的近端(或顶端,如图所示)或其附近的至少一个连接部分422。利用这连接部分422,用于接合如以下所述的在现场形成的矫形的脊柱稳定植入物。连接部分422较佳地是入口422,用于实现更牢固的接合。在一实施例中,经皮进入套管100延伸通过两个或多个骨固定件410的入口422,以形成一通道,便于现场形成的矫形的脊柱稳定植入物插入。
现在以下将叙述带有两个骨固定件的实施例。经皮进入套管100延伸通过一第一骨固定件410的入口422,然后通过一第二骨固定件410的入口422。较佳地将第一骨固定件410植入第一骨内。可以将第二骨固定件410插入第二骨内。这些骨可以是相邻的椎体或椎骨,或者由一个或多个中间椎骨分开的第一和第二椎骨。以下进一步详细叙述临床手术。
图8-11的骨固定件410由例如钛或不锈钢的生物适应的材料制成。或者,可以由复合材料制造骨固定件410。还可以由适当的医学等级聚合物制造骨固定件410。在一实施例中,骨固定件410的长度在约40毫米和60毫米之间。较佳的为约50毫米。但是,它的实际长度取决于骨折的位置、病人的身体尺寸等。
骨固定件410包括具有近端414的近部412和具有远端418的远部416。近部412通常包括头部420和入口422。在较佳实施例中,头部420包括被构成与螺丝起子的末端相配合的近部424。头部420可以包括用于与螺丝起子配合的标准的或十字形(菲利普斯式)狭槽。许多槽结构也是合适的,例如六角的、Torx、矩形的、三角形的、曲线形的或任何其它合适形状。图11的骨固定件具有凸起的平台434,该平台具有多个基本平侧面,例如六角形平台,该平台被构造成与在螺丝起子的远端内相应的凹入部分配合。平台434可以为适合与螺丝起子相配合的许多形状。
骨固定件410的入口422可以延伸穿过头部420,它的直径通常在约4毫米和8毫米之间,较佳地约6毫米至约8毫米。入口422可以为任何合适的形状;但是,入口422较佳地是圆形的,以便于经皮的管子100以及现场形成的矫形的脊柱稳定植入件的插入。
骨固定件410的远部416通常包括螺纹426和尖锐末端428。骨固定件410还较佳地包括同轴线地从它的近端414通过骨固定件410的长度延伸到达它的远端418的中心内腔430,以及该内腔被构造成接纳引导线。骨固定件410还可以包括一个或多个穿孔432,如图11所示。这些穿孔432与骨固定件410的中心内腔430连通。这些孔432可以轴向对齐,如图所示,或者可以轴向交错。穿孔432允许骨头长入骨固定件410,将骨固定件410稳定在骨头内。此外,例如羟磷灰石制剂的骨基质材料可以注入中心内腔430和通过穿孔,以促进骨头在内部的生长。
随后的附图示出按照本发明的一方面的、使用经皮的出入套管100以便于插入现场形成的矫形脊柱稳定植入件的方法。在这实施例中,首先在两个或多个相邻的骨固定件之间形成平滑的通道,以便于在其远端装有可膨胀的矫形固定装置的另一扩展导管的通过。虽然仅参照两个椎骨来揭示和画出该方法,且其中一个椎骨是不稳定的、分离的或移位的,另一个椎骨不是不稳定的、分离的或移位的,但是该方法还可以同时应用于三个或多个椎骨。并且,该方法还可以利用L5与之固定L5的骶骨的向颅侧部分作为“椎骨”来稳定L5椎骨。如本领域的那些熟练人员参照这揭示内容会理解的那样,虽然该方法揭示和画出为应用在脊椎柱的左侧上,但是该方法还可以应用在脊椎柱的右侧上,或者较佳地应用在脊椎柱的两侧上。其它的应用包括稳定身体的其它骨头和骨架部分。
图12示出了穿过骨膜表面并进入椎骨500和502的前椎体或其它适当部分的两骨固定件410。如以上所述,诸如羟磷灰石制剂之类的骨基质材料可以注入骨固定件410的中心内腔430和穿过其穿孔(在这附图中不可见),以促进骨头在内部的生长。将两骨固定件410设置成它们的入口422基本上相互同轴线。
在荧光屏的帮助下,将空心针436经皮地插入并前进入骨固定件410的一个的入口422。空心针436的规格可以是16或18。如该领域的那些熟练人员参照该揭示内容会理解的那样,虽然示出空心针436接合在向颅侧椎骨502内的接骨螺钉410,但它可以首先接合在向尾侧椎骨500内的接骨螺钉410。图13是空心针436的远端的放大图。将半刚性引导线438引入穿过中空针436的内腔和在向颅侧椎骨502内的骨固定件410的入口422。中空针436较佳地具有Tuohy针尖,该针尖使引导线438被垂直于骨固定件410的中心内腔430、或者与骨固定件410的入口422的轴线同轴线地引出中空针436。或者,可以用倾斜尖端改进的Ross针或者如本领域的那些熟练人员参照本揭示内容会理解的另一合适的结构实现引导线438穿过骨固定件410的入口422的弯曲。
图14示出了按照本发明的一方面的、经皮地插入在两骨固定件410之间的可选用的引导线引导装置440。引导线引导装置440可以具有叉端,利用该叉端将引导线438引导通过在向尾侧椎骨500内的骨固定件410的入口422。在另一实施例中,可以将诸如圈套或钳子之类的引导线获取装置442经皮地在尾侧插入向尾侧椎骨500内的骨固定件410的入口422。在引导线438通过在向尾侧椎骨500内的骨固定件410的入口422之后,引导线获取装置442接合引导线438的远端,并在背侧拉它通过皮肤,以便固定引导线438的两端。
图15示出了在图12-14中的上述过程之后处于适合位置中的引导线438。
可以将引导线438插入经皮进入套管组件150的扩展导管300的引导线内腔304内。整个组件150可以在引导线438上运行,直至它的变细远部插入通过骨固定件410的入口422。因为在经皮进入套管组件150的外部上的插入套管200的光滑的、较小的轮廓外部,所以便于插入。如上所述,它可用聚四氟乙烯制成。
在经皮进入套管组件150插入之后,拆去插入套管200。可以通过在拉接头204上拉动并沿着穿孔、折缝线或沿着它的限制段210设置的便于撕去的其它结构撕去插入套管200完成这工作。可以首先通过局部地膨胀扩展导管300的气囊310来促进这项工作。如以上所述,气囊310设置在经皮进入套管100的远段110内,该远段自身又设置在插入套管200的限制段210内。从而,膨胀气囊310使经皮进入套管100的远段110膨胀,沿着它的穿孔撕去插入套管200的限制段210。
在拆除了插入套管200之后,可以充分膨胀气囊310,将经皮进入套管的远段110膨胀到它的全部横剖面外形。然后可以使气囊310放气,以易于去除扩展导管300。如以上所述,通过连接于扩展导管300的孔口320的泵可以对气囊310充气和放气,较佳地泵送对比介质,以较好地告知气囊的状态。
这样将经皮进入套管100插入通过骨固定件410的入口422。通过骨固定件410的入口422形成该光滑的通道便于在它的远端带有可膨胀的矫形固定装置的另一扩展导管的通过。在于2002年5月31日递交的美国专利申请系列号10/161,554中揭示了在它的远端带有可膨胀的矫形固定装置的扩展导管以及相关联的固定件的的例子,该专利的全部揭示内容结合在此供参考。
虽然已参照某些较佳实施例叙述了本发明,但是对本领域的那些熟练人员来说,鉴于这里所揭示的内容,包括尺寸、结构和材料方面的变化的其它实施例将是很明显的。此外,与任何一个实施例相联系所讨论的所有特征能够易于适用于这里所述的其它实施例。在不同实施例中,对于类似特征所用的不同术语或标号并不意味着与可以明显地叙述的内容有所不同。因此,本发明的范围仅由所附权利要求书确定,以及不局限于本文所述的较佳实施例。
Claims (14)
1.一种经皮进入套管,它包括:细长的管状结构,所述细长的管状结构的至少一部分可以从一较小的第一横剖面外形膨胀到一较大的第二横剖面外形;和由该进入套管所携带的可释放的套管,用于将所述细长的管状结构的至少一部分限制在所述较小的第一横剖面外形中。
2.如权利要求1的经皮进入套管,其特征在于:与可膨胀的气囊组合,用于将所述部分从所述较小的第一横剖面外形膨胀至所述较大的第二横剖面外形。
3.如权利要求2的经皮进入套管,其特征在于:由气囊导管来载带气囊,该导管在经皮进入套管内可以轴向可动地定位。
4.一种经皮进入套管,它包括:细长的管状结构,所述细长的管状结构具有可从较小的第一横剖面外形膨胀至较大的第二横剖面外形的远段;和用于将所述细长的管状结构的所述远段限制在所述较小的第一横剖面外形中的可释放的限制件。
5.如权利要求4的经皮进入套管,其特征在于:可释放的限制件包括可撕去的套管。
6.一种提供经皮进入的方法,所述方法包括:
经皮地插入具有较小的第一横剖面外形的细长的管状结构;
从细长管状结构拆去管状的限制件;以及
将所述细长管状结构从所述较小的第一横剖面外形膨胀至较大的第二横剖面外形。
7.如权利要求6的方法,其特征在于:附加地包括膨胀气囊以将所述细长管状结构从所述较小的第一横剖面外形膨胀至所述较大的第二横剖面外形的步骤。
8.如权利要求6的方法,其特征在于:经皮插入步骤包括将细长管状结构经皮地插入通过在骨固定件内的孔。
9.如权利要求6的方法,其特征在于:经皮的插入步骤包括经皮地将细长管状结构插入通过连接于椎体的固定件内的孔。
10.如权利要求6的方法,其特征在于:还包括在管状结构处于较大的第二横剖面外形中时引导植入物穿过管状结构的步骤。
11.如权利要求10的方法,其特征在于:植入物包括在适当地方形成的矫形植入物。
12.如权利要求6的方法,其特征在于:经皮插入步骤包括经皮地将细长的管状结构插入穿过连接于一第一椎体的至少一第一骨固定件和连接于一第二椎体的一第二骨固定件的步骤。
13.如权利要求7的方法,其特征在于:利用定位在管状体内的气囊导管实现膨胀气囊的步骤。
14.如权利要求7的方法,其特征在于:还包括在膨胀步骤之后从管状结构去除气囊的步骤。
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2002
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2003
- 2003-07-01 WO PCT/US2003/020550 patent/WO2004004584A1/en active Application Filing
- 2003-07-01 EP EP03763054A patent/EP1539007A4/en not_active Withdrawn
- 2003-07-01 EP EP10193167.3A patent/EP2305156B1/en not_active Expired - Lifetime
- 2003-07-01 JP JP2004519695A patent/JP4344317B2/ja not_active Expired - Fee Related
- 2003-07-01 KR KR1020057000092A patent/KR101028295B1/ko not_active IP Right Cessation
- 2003-07-01 CA CA002491493A patent/CA2491493A1/en not_active Abandoned
- 2003-07-01 AU AU2003251745A patent/AU2003251745B2/en not_active Ceased
- 2003-07-01 CN CNB038191644A patent/CN100518682C/zh not_active Expired - Lifetime
-
2005
- 2005-08-10 US US11/200,144 patent/US8034072B2/en not_active Expired - Fee Related
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2006
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108697438A (zh) * | 2016-01-21 | 2018-10-23 | 波士顿科学医学有限公司 | 医疗装置及其相关使用方法 |
CN110753566A (zh) * | 2017-06-13 | 2020-02-04 | 波士顿科学国际有限公司 | 具有可扩张能力的导引器 |
CN108578806A (zh) * | 2018-05-17 | 2018-09-28 | 上海军慧医疗管理有限公司 | 一种一次性经皮腹膜透析导管置管用穿刺装置 |
Also Published As
Publication number | Publication date |
---|---|
AU2003251745A1 (en) | 2004-01-23 |
KR20050123086A (ko) | 2005-12-29 |
EP2305156A2 (en) | 2011-04-06 |
US20040006344A1 (en) | 2004-01-08 |
US20060142795A1 (en) | 2006-06-29 |
EP1539007A4 (en) | 2008-09-10 |
JP4344317B2 (ja) | 2009-10-14 |
CA2491493A1 (en) | 2004-01-15 |
EP2305156A3 (en) | 2011-07-06 |
US7914555B2 (en) | 2011-03-29 |
EP2305156B1 (en) | 2016-09-28 |
KR101028295B1 (ko) | 2011-04-11 |
US7329268B2 (en) | 2008-02-12 |
JP2005532114A (ja) | 2005-10-27 |
AU2003251745B2 (en) | 2008-02-21 |
US20060036276A1 (en) | 2006-02-16 |
EP1539007A1 (en) | 2005-06-15 |
US8034072B2 (en) | 2011-10-11 |
CN100518682C (zh) | 2009-07-29 |
WO2004004584A1 (en) | 2004-01-15 |
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