CN102046112B - 导管输送装置 - Google Patents
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Abstract
一种用于自扩张支架的导管输送装置,包括:远侧导管部件,布置在支架上的远侧鞘,限定管的近侧导管轴;连接到远侧鞘的近侧鞘,其限定容纳导管轴的内腔;敞开远端,所述敞开远端适合于接纳与导管轴的远端并排的远侧导管部件的近端;以及围绕导管轴的套管,其具有远端,所述远端可伸缩地接纳远侧鞘的近端。
Description
技术领域
本发明涉及一种导管,所述导管是用于将被经腔输送到体内的支置位置的自扩张支架的输送装置。所述装置是“拉丝”式的并且被设计用于输送明显长度的覆膜支架,这代表比短裸支架更困难的输送任务。下面所述的装置属于“整体交换(over the wire)”类型。然而,本发明也可以应用于“快速交换”导管输送装置。18或35“thou”的导丝直径是常规的,并且预期用于本发明。带有在6mm到18mm的范围内的展开直径的覆膜支架是预期的。
背景技术
本申请人逐步开发了用于覆膜支架的输送装置。可以在WO2005/053574中找到一个例子。本发明将这样的构造发扬到覆膜支架的技术领域中,所述覆膜支架更长(可能达到120mm,甚至以上)并且因此在支架的部署期间,当相对于支架必须朝近侧牵拉围绕支架的鞘以从覆膜支架的远端开始逐渐将支架释放到待支置的体腔中时,对输送系统的强度要求更大。读者将会理解这样的导管输送装置的特征在于,在支架的逐渐部署期间两个端对端部件中的一个在端部张紧(该部件负责朝近侧牵拉鞘),而两个端对端部件中的另一个(防止支架随着朝近侧移动的鞘朝近侧被牵引的那个)端对端压缩。通常,用于自扩张支架的导管输送装置的设计者设法保持导管的通过直径最小,不言而喻这与受压缩的端对端部件在支架部署期间不弯折或折叠或以另外方式失去它的长度完整性的设计要求矛盾。为了在输送较长覆膜支架中的增强性能,本发明牺牲了通过直径的狭窄,对于较长覆膜支架来说,在支架的部署期间在导管输送装置中的端部应力很可能高于裸露而不是覆膜的较短支架。
具有“拉丝”的导管输送装置对于端对端应力较大的任务来说是有吸引力的,原因是丝线能够很好地承受端部张力,但是不太适于承受端部压缩应力。对于该任务来说更好的是管。因此,在同轴系统中,用管承受压缩应力并且其内的丝线承受拉伸应力的系统很可能比以相反方式布置的系统性能更好。然而,在支架所处的系统的远端,受到张力的是外部鞘,而受到压缩的是阻止支架朝近侧移动的内部导管元件。因此,在拉丝构造的导管输送系统的近端和远端之间的某处,需要有转换以将来自径向内拉丝的拉伸应力传送到围绕支架的径向外鞘。明显地,在传送区域与支架的远端之间的任何长度间隔需要足够强以在这样的支架部署期间保持它的纵向完整性,其中导管系统的直径较小部件需要在支架部署期间承受端部压缩应力。不言而喻,该部分的长度应当尽最大可能被减小。
拉丝系统中的传送区域的另一个问题是最小化导管系统在沿着它的长度的任何特定点的任何弯折倾向。明显地,在沿着导管轴的长度的某处包含传送区域,而同时避免沿着导管的长度的任何点有弯折增加的风险是有挑战的。
发明内容
根据本发明的导管输送装置在朝近侧牵引以释放支架的系统的部分的构造中具有新颖性。备选地,它们可以在支架部署期间固位支架防止朝近侧缩回的系统的部分中具有新颖性。优选地,在一起协同工作的系统的这些组成部分的两者中都有新颖性。对导管输送装置的构造的每一个贡献凭自身构成本发明,但是后拉部件的改进构造与在支架部署期间承受端对端压缩的部件的改进构造的组合可以产生协作效果,允许通过窄的曲折内腔部署相当长的覆膜支架假体。
根据本发明的第一方面,提供了一种导管输送装置,其中套管围绕导管轴并且具有远端,所述远端可伸缩地接纳所述装置的远侧鞘的近端,拉丝固定到在套管的内腔内的远侧鞘的近端区域。
通常,套管近端固定到致动装置(也被称为“手动单元”)的接口。常规地,所述输送装置包括固位环,所述固位环将拉丝固位在远侧鞘的近端区域的径向外表面上,所述环靠近它的近端包围远侧鞘的径向外表面。通常,拉丝的远端区域被薄化并且被赋予圆柱表面的一部分的形状,具有的半径对应于靠近它的近端的远侧鞘的径向外圆柱表面的半径,由此拉丝的薄化端部区域可以与远侧鞘的径向外表面齐平或接近齐平放置,并且常规地通过通常是型锻环的固位环夹紧到所述外表面。
本领域的技术人员将能够预见将鞘扩展到拉丝中的其他方式。例如,鞘的材料本身可以朝近侧连续以形成拉丝。
在一个优选实施例中,远侧鞘具有在支架的位置的近侧的潜入管。发明人将装置的该部件称为“潜入”管是因为它“潜入”套管的敞开远端中并且在支架的部署期间在套管的内腔内朝近侧滑动。所述潜入管具有的外径略小于包围支架的远侧鞘的远侧部分的更远侧部分的外径。常规地,潜入管的远端固定地接纳在远侧鞘的远侧部分的敞开近端内部。对于作为整体的导管装置,向内渐缩的无损伤末端可以设在远侧鞘的远侧部分的近端。通常,在套管的内腔内部,拉丝将附连到相对接近潜入管的近端的潜入管的区域。
常规地,在支架输送系统中,无损伤末端设在延伸通过支架的内腔的轴向部件上,支架鞘终止于所述无损伤末端的近侧。这样的布置适合本发明并且可以提供它的实施例。
在本发明的另一个方面中,所述输送装置的内导管部件包括具有内腔的近侧鞘,所述内腔容纳所述输送装置的导管轴。它具有敞开远端,所述敞开远端接纳与导管轴的远端并排的远侧导管部件的近端。近侧鞘和远侧导管部件一起提供沿着所述输送装置的全部长度延伸的导丝内腔,由此使该输送系统成为“整体交换”类型中的一员。在一个优选实施例中,在管轴的一侧的导管的管的远端承载包围远侧导管部件的近端的传送环。我们将该环称为“传送”环是因为它在支架的部署期间标记在由导管轴的管构成的外同轴部件与在所述输送装置的远端、在朝近侧被牵拉以释放支架的远侧鞘内部的内同轴部件之间的端部压缩应力的传送。
读者将能够预见传送环的替换选择。取决于导管的管和远侧导管部件的构造材料,可以用诸如胶粘、熔焊、绑扎在一起或铜焊这样的技术以及形状配合和实现耐受轴向缩短的机械干涉的其他方式并排联接这两个部件。
如上所述,作为整体的导管系统必须阻止在端部压缩下纽结的任何趋势。过渡区域特别易于受到不希望的纽结的影响。所以在并排部件传送区域安装额外的夹板或套筒是值得的,从而增强在该区域中的抗纽结性。
在支架的部署中在朝近侧缩回围绕鞘期间阻止支架朝近侧移动的常规方式是提供“止动环”的形式,无论何时支架试图朝近侧移动,支架的近端都邻接所述止动环。通常,这样的布置不会对支架基体的任何部分施加不适当的压缩应力。然而,在支架可能易于受到过大端对端压缩应力影响的情况下,更好的布置是在支架的长度的更大部分上而不仅仅是支架圆柱的近端表面为支架圆柱提供防止朝近侧移动的支撑措施。由于本发明的导管输送装置特别适用于长覆膜支架,因此将远侧导管部件延续到支架支撑管中是有利的,所述支架支撑管在使用中位于支架的内腔中,并且在该内腔周围支撑支架,在朝近侧缩回围绕鞘期间防止相对于远侧导管部件朝近侧缩回。在一个优选实施例中,支架支撑管带有多个环形衬垫,所述环形衬垫与在支架支撑管的径向外部的支架的覆膜内腔表面机械干涉。
词语“衬垫”应当作广义理解。例如,压靠在假体或植入物、覆膜支架或裸支架的内腔表面上的简单径向螺旋突出可以用于预期目的。其他布置已经存在于公开专利文献中,并且当支架长度继续增加时变得更多。
申请人以前开发了用于自扩张支架的输送系统,其中远侧鞘和支架相对于导管轴自由同轴旋转。尽管这对于工程师来说也是可能的,但是本发明预见了也可以将支架支撑管固定到导管轴而不自由旋转,由此固定(通过支架)外鞘防止相对于导管轴旋转。通过这样的禁止旋转,不会有拉丝自身缠绕其他导管轴部件的风险。
位于支架的近端的近侧的远侧导管部件需要具有足够的纵向强度以当支架正被释放时耐受施加于其上的压缩应力。提高导管部件的纵向强度的已知方式是用螺旋线缠绕它。因此,在本发明的一个优选实施例中远侧导管部件的复合导管部分包括螺旋线,从而当复合导管部分受到端对端压缩时硬化复合导管部分。
读者将充分意识到获得足够高的压缩应力耐受性和足够的纵向强度的重要性。同样在该设计领域中,专利文献为读者提供了螺旋线缠绕的许多替换选择。具体地,例如带有横向于其长度方向的大量壁贯穿狭缝的不锈钢或PHYNOX(RTM)的金属管可以组合高挠性与高纵向强度。对于相关公开,参见WO2006/133960和EP-A-1656963。
在一个实施例(未显示)中,远侧导管部件的近端区域包括具有大量狭缝的长度部分,它们的长度方向横向于远侧导管部件的长度。这样的狭缝可以至少在远侧导管部件的近端区域中增加它的弯曲挠性。有益地,带狭缝的长度部分朝着支架的近端的位置朝远侧延伸。朝远侧延伸通常一直到支架的近端,但是可能不是自始至终,例如如果远侧导管部件在位于支架的近端的近侧的区域中具有从金属到聚合物的材料变化。
适宜地,所述输送装置包括带有内腔的连接管,所述内腔在它的远端接纳支架支撑管的近端,并且在它的敞开近端接纳复合导管部分的远端。粘合剂可以用于建立远侧导管部件的组合。在支架支撑管上的环形衬垫可以具有其他形式,实际上是能够阻挡支架朝近侧相对于远侧导管部件的相对轴向运动的任何合适的“浮凸”形式。
在上面提出了支架的内腔内的衬垫可以完全代替邻接支架的近端的“推”环。然而,邻接支架的近端的环也可以设在这里。在一个实施例中,它帮助衬垫。在另一个实施例中,它故意与假体的近端间隔开,并且仅仅在衬垫不知何故未能在假体的部署期间防止假体整个朝近侧移动的情况下邻接该近端。
附图说明
为了更好地理解本发明,并且为了更清楚地显示如何实现本发明,将在将通过例子参考附图,在附图中:
图1是根据本发明的导管输送装置的第一实施例的远端部分的纵向直径截面;
图2是部分分解以单独显示单个部件的图1的输送装置的示意性纵向直径截面;
图3是与图1和2中相同,但是显示处于它的组装形式的装置的纵向直径截面;以及
图4是通过复合导管部分的纵向直径截面。
具体实施方式
所示的输送系统10用于输送覆膜支架12,在图1中可以看到在具有无损伤渐缩远侧末端16的远侧鞘14内部被压缩的覆膜支架。支架是自扩张支架,它压在外鞘14的径向内圆柱表面上。支架支撑管18在径向压缩支架12内部,所述支架支撑管限定导丝内腔(在图1中不可见)并且在它的外圆柱表面上承载多个环形衬垫20。对于长度大于100mm的覆膜支架,我们建议靠近支架的近端有三个这样的衬垫,在支架的远端有一个,并且沿着支架的长度在中途有一个。对于更短的支架,沿着支架在中途的衬垫很可能不需要。衬垫由DYMAX材料制造并且每个可以沿着支架的轴具有在2mm到4mm的范围内的长度。取决于衬垫如何附连到支撑管18,有益的是在管的远端提供安全元件,即,某种形式的止动器,其将在支架的部署期间阻止任何环形衬垫意外地滑离支撑管的远端。
在图1中,支架支撑管18具有被接纳在短连接管22内的近端,所述短连接管也接纳基于聚酰亚胺管的复合导管部分24的远端,所述聚酰亚胺管在它的环形壁厚度内具有编织物增强,当朝近侧远离支架12牵拉远侧鞘14以从输送系统释放它时所述复合导管部分一定会承受纵向压缩应力。从鞘周围牵拉远侧鞘14的是远侧鞘的近端部分,我们称之为“潜入鞘”26,其具有的外径略小于远侧鞘14的内径并且其远端接纳在远侧鞘14的近端的内腔内部,在那里它由粘合剂固定。潜入鞘26有间隙地围绕复合导管部件。我们建议它由编织聚酰亚胺制成,壁厚为100μm。在可用较小直径导管轴输送的较大直径假体的情况下,可以是远侧鞘14的内径明显大于潜入鞘的远端的外径。在这样的情况下,在两个部件之间提供中间间隔套筒是有用的。
在潜入鞘的内腔中的复合导管部件具有聚酰亚胺轴元件28,所述聚酰亚胺轴元件限定导丝内腔并且在它的外圆柱表面上胶粘承载细线30的螺旋绕组,所述螺旋绕组用于硬化管28防止弯曲,而不会有弯曲挠性的太大损失,尤其当管28受到端部压缩时。
在离开图1之前,读者应当注意不带有潜入鞘26的远侧鞘14可以在导管输送装置的制造期间充当预组件,支架支撑管18和支架12插入鞘14中以构成子组件。在制造的后期阶段,可以例如使用在200℃左右的PET收缩管通过围绕管18和支架支撑管18两者热缩聚酰亚胺连接管22将复合导管部分的管28连接到支架支撑管18。在这样的收缩之后,去除和丢弃PET管。其后,可以在有或没有中间间隔套筒的情况下将潜入鞘26引入远侧鞘14中并且用粘合剂与其固定。
现在转到附图的图2,我们看到输送装置的部件以“分解”形式布置,内和外同轴元件的部件刚好足够分开。因此,远侧鞘14和潜入鞘26的子组件被显示为从支架支撑管横向移位,但是与具有远端42的套管40同轴,所述远端接纳潜入鞘26的近端44。套管40的近端通过粘合剂固定到手动单元的应变消除接口46,所述手动单元将致动从输送装置部署支架。在支架的部署期间,远侧鞘14和潜入鞘26朝近侧移动,但是套管40不会,使得潜入鞘26的近端沿着套管40的内腔从敞开远端42朝近侧滑动。
我们暂时转到图3来完成远侧鞘的朝近侧运动的描述。图3显示了一对固位带50,所述固位带被型锻为围绕潜入鞘26的近端区域的环。这些环压在潜入鞘26的外圆柱表面上,在其位于型锻带50之下的远端具有展平部分54的拉丝52的远端压靠在潜入鞘26的表面上。使用激光焊接来将拉丝焊接到固位带50。从拉丝52的近端56的近侧施加的拉丝52中的张力牵拉潜入鞘,并且因此牵拉远侧鞘14远离支架12。
返回附图的图2,我们再次看到支架支撑管18、连接管22和复合导管部分24。我们也看到复合导管部分24的管28的近端60保持在围绕近端60型锻的传送环62内。该传送环被焊接到PHYNOX合金的导管轴管64,所述导管轴管限定形成拉丝52的通道的内腔。
近侧鞘66围绕嵌入的导管的管64,但是导管的管64远离近侧鞘66的旋转轴线。这使近侧鞘66的内腔的大部分横截面自由用于冲洗液和导丝。由近侧鞘66限定的导丝内腔延续到复合导管部分和支架支撑管的内腔中。鞘66的近端68设置在与承载套管40的近端相同的接口46中,使得在套管40与近侧鞘66之间没有相对端部运动。请注意在附图的图2和3中直径与长度的比率与实际没有关系,其中装置的总长度很可能将明显大于100cm,而预期通过直径小于3mm(7弗伦奇或8弗伦奇)。例如从图2可以看出至少当部署支架时潜入鞘26将邻接近侧鞘66。然而,参见图3,我们看到在潜入鞘26与近侧鞘66的远端之间有很显著的端对端间隙。图3中的图示对于近侧鞘66的长度是误导。实际上,它占据系统的全长的很大部分。远侧鞘14、潜入鞘26和在近侧远至传送环62的复合导管部分24的全长将远远小于导管系统的全长的50%。实际上,并且在植入物的部署之前,潜入鞘26的近端在远侧离近侧鞘66的远端有相当远的距离,如图3中所示,但是与图2的分解图给予的印象相反。
对于复合导管部分的更详细描述,参见下文,其描述了在附图的图4中显示的内容。
在操作中,将输送装置(它的远端区域看上去像它在图1中所表示的)经腔引入体内,并且如本身已知的那样推进,直到远端在体内的位置是想要支置的地方。在该点,当支架将被部署时,致动手动单元以从拉丝的近端56将拉伸应力施加于拉丝52。该拉伸应力传到远侧鞘14,所述远侧鞘随着潜入鞘26滑动到套管40中朝近侧移动。支架12将倾向于随着外鞘14朝近侧被带动,除非通过支架支撑管18的衬垫20与覆膜支架的内表面相互作用来防止它这样做。支架支撑管18随着外鞘14朝近侧移动的任何趋势由压缩应力抵抗,所述压缩应力沿路从致动单元沿着导管的管64,通过传送环62并沿着复合导管部分24,一直到与连接环22内部的支架支撑管18的端对端邻接部,并且因此一直到衬垫20和支架而生成。
在成功部署支架之后,回缩和去除输送装置是相对简单的。导管系统的圆柱外表面是通常平滑的,而且很可能涂覆有润滑涂层。在系统的缩回期间,系统的无损伤远侧末端16伸展以朝近侧通过覆膜支架,但是仍然残留向内渐缩。在支架内部,从远端之外到支架内腔的近侧,没有必须通过支架的内腔的庞大末端结构。相反地,必须朝近侧滑到支架内腔之外的唯一结构是支架支撑管18,这表示在支架的内部绊住的趋势很小。
现在转到附图的图4,我们发现以更大的比例显示复合导管部分24使得可以更清楚地看到它的结构细节。部分24基于聚酰亚胺管28,所述聚酰亚胺管在它的环形壁厚度内包括扁平丝的编织物。环形壁厚度为0.075mm并且外径为1.16mm。内径为1.01mm并且扁平编织丝具有厚度为0.013mm并且宽度为0.076mm的矩形横截面。编织物基于SS304W钢材料,以100PPI(每英寸交点)编织。在编织物中一共有16个丝带。
现在转到在聚酰亚胺管28的外圆柱表面上的多股线的螺旋绕组,这用腈基丙烯酸酯胶水胶粘到管,在缠绕之后,螺旋线圈的外径为1.5mm(公差为0.02mm)。在安装到管28上之后,将螺旋线圈研磨到1.4mm的最终外径。从附图4明显看出,螺旋线圈并不覆盖复合导管部件的整个轴向长度。在近侧,它未到达传送环62。在远侧,它离管28的远端有50mm,远未到达连接管28,并且在附图1中可以看到,远未到达位于覆膜支架12的径向外部的鞘14的近端。
本领域的技术人员将显而易见附图中所示的输送装置的结构变化。材料选择是输送系统设计者的日常事务的一部分,可靠地连接输送系统的单个部件的方法的选择同样如此。支架输送系统的许多单个特征本身是已知的,但是在支架输送装置中使用的大量常规特征可以组合和匹配,以满足待执行的输送任务的特定要求。需要考虑的设计因素的数量几乎是无限的。因此,将允许输送比迄今为止更长、比迄今为止具有更大径向支置力、超过迄今为止可用的任何输送系统的能力的覆膜支架的单个部件的协作组合放在一起,对本领域做出了有价值的和重要的贡献。
工业实用性
公开了一种导管输送装置,其具有特定构造,所述特定构造能够将具有比迄今为止可能的更大长度和更高支置力的覆膜自扩张支架输送通过具有窄直径的曲折体腔。
Claims (10)
1.一种用于自扩张支架(12)的导管输送装置(10),所述导管输送装置设置有远侧导管部件(18,24)和远侧鞘(14,26),所述远侧鞘通过相对于所述远侧导管部件和所述支架朝近侧移动来释放支架,并且所述导管输送装置包括近侧导管轴,所述近侧导管轴具有导管轴管(64)和在所述导管轴管的内腔内的拉丝(52),所述拉丝附连(50)到所述远侧鞘,由此相对于所述导管轴管朝近侧牵拉所述拉丝使得朝近侧牵拉所述远侧鞘,从而从所述支架的远端开始逐渐释放所述支架,所述导管轴管附连(62)到所述远侧导管部件(24)的近端区域(62)并且当朝近侧牵拉远侧鞘时用于通过端部压缩阻力来阻止所述支架朝近侧移动,并且
其特征在于,
所述导管输送装置包括套管(40),该套管围绕导管轴管并且具有远端,该套管的远端可伸缩地接纳所述远侧鞘的近端,所述拉丝固定到在所述套管的内腔内的所述远侧鞘的近端区域。
2.如权利要求1所述的导管输送装置,其中,所述套管的近端被固定到一致动装置的接口(46)。
3.如权利要求1或2所述的导管输送装置,包括将所述拉丝固位在所述远侧鞘(26)的近端区域的径向外表面上的环(50),所述环包围所述远侧鞘的所述径向外表面。
4.如权利要求1所述的导管输送装置,其中,所述拉丝的远端区域(54)被薄化并且被赋予圆柱表面的一部分的形状,具有的半径对应于远侧鞘的外圆柱表面的半径,由此被薄化的远端区域能够与所述远侧鞘的径向外表面齐平或接近齐平放置。
5.如权利要求1所述的导管输送装置,其中,所述远侧鞘具有潜入管(26)和用于包围覆膜支架的远侧部分(14),所述远侧部分具有敞开近端,所述潜入管的远端被固定地接纳在所述敞开近端中,所述潜入管具有近端区域,所述潜入管的近端区域可伸缩地被接纳在所述套管(40)的内腔的敞开远端中。
6.如权利要求1所述的导管输送装置,其中,所述远侧鞘的远端(16)在使用中将被布置在所述支架的远侧,所述远侧鞘的远端向内径向渐缩以提供所述装置的无损伤末端。
7.一种用于自扩张支架(12)的导管输送装置(10),所述导管输送装置设置有远侧导管部件(18,24)和远侧鞘(14,26),所述远侧鞘通过相对于所述远侧导管部件和所述支架朝近侧移动来释放所述支架,并且所述导管输送装置包括近侧导管轴(64),所述近侧导管轴具有导管轴管(64)和在所述导管轴管的内腔内的拉丝(52),所述拉丝附连(50)到所述远侧鞘,由此相对于所述导管轴管朝近侧牵拉所述拉丝使得朝近侧牵拉所述远侧鞘,从而从所述支架的远端开始逐渐释放所述支架,所述导管轴管附连(62)到所述远侧导管部件的近端区域(60)并且当朝近侧牵拉远侧鞘时用于阻止所述支架朝近侧移动,并且
其特征在于,
所述导管输送装置包括:
内部部件,该内部部件包括具有内腔的近侧鞘(66),所述近侧鞘的内腔容纳所述导管轴管(64)并且具有敞开远端,所述敞开远端接纳与所述导管轴的远端并排的所述远侧导管部件(24)的近端,以限定连续导丝内腔(66,24),所述导丝内腔沿着组合长度延伸,该组合长度包括近侧鞘(66)的内腔的长度以及沿所述远侧导管部件(24,22,18)的长度延伸的内腔的长度;以及
套管(40),该套管围绕所述导管轴并且具有远端(42),该套管的远端可伸缩地接纳所述远侧鞘(26)的近端,所述拉丝固定(50)到所述远侧鞘的近端区域。
8.如权利要求7所述的导管输送装置,其中,所述近侧导管轴的导管轴管和所述远侧导管部件的近端区域均基本或完全由金属组成。
9.如权利要求7所述的导管输送装置,其中,所述远侧导管部件的近端区域包括具有多个狭缝的长度部分,所述狭缝的长度方向横向于所述远侧导管部件的长度,由此增加所述远侧导管部件的所述近端区域的弯曲挠性。
10.如权利要求9所述的导管输送装置,其中,所述长度部分朝远侧延伸通过到所述支架的近端的位置的距离的至少大部分。
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WO2009149927A1 (en) | 2009-12-17 |
EP2293744B1 (en) | 2016-12-21 |
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CA2721902C (en) | 2017-07-25 |
CA2970877C (en) | 2019-09-10 |
US20210393423A1 (en) | 2021-12-23 |
BRPI0915103A2 (pt) | 2016-02-10 |
CA2970877A1 (en) | 2009-12-17 |
CA3050184A1 (en) | 2009-12-17 |
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