CN101573079A - 硬组织锚固件和输送装置 - Google Patents

硬组织锚固件和输送装置 Download PDF

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CN101573079A
CN101573079A CNA2007800450389A CN200780045038A CN101573079A CN 101573079 A CN101573079 A CN 101573079A CN A2007800450389 A CNA2007800450389 A CN A2007800450389A CN 200780045038 A CN200780045038 A CN 200780045038A CN 101573079 A CN101573079 A CN 101573079A
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hard tissue
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A·G·伯达利斯
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Spinal Modulation LLC
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Abstract

本发明提供一种用于将医疗装置固定到特别是椎骨的例如骨或者骨结构的硬组织的装置、系统和方法。通过将这些装置直接锚固到硬组织周围，这些装置被更加靠近治疗源锚固。这提供了另外的稳定性并减少了装置在治疗部位的移位。同样，通过连接到硬组织而不是软组织，通常能够实现更牢固的连接。

Description

硬组织锚固件和输送装置
相关申请的交叉引用
本申请要求2006年12月6日提交的临时专利申请No.60/873549(律师卷号No.10088-708.101)的优先权，该申请出于所有目的通过引用结合在此。
以联邦资助研究和发展名义作出的发明权利的声明
不适用
对于由CD提交的“序列”列表或计算机程序列表附录的参考
不适用
背景技术
已经利用各种可植入医疗装置来治疗位于患者体内的骨或者骨结构附近的解剖部分。通常该装置通过将装置的部分缝合到软组织周围来锚固就位。该装置通常包括位于沿着装置的预定位置处专为这个目的设计的缝线孔。因此，该装置仅能缝合在这些位置处，限制了可用于缝合到其上的组织的区域和类型。通常，该位置远离治疗部位。锚固组织的这种距离和不稳定性会导致导线移位和脱离。
例如，常规的脊髓电刺激器(SCS)沿着脊柱定位来治疗疼痛。常规的SCS系统包括可植入导线和可植入电源或者可植入脉冲发生器IPG。利用荧光透视法，导线可植入到脊柱的硬膜外腔中并抵靠脊髓的硬脊膜层定位。导线从脊柱延伸到远程地植入的IPG。通常，导线被缝合到远离进入硬膜外腔的位置的软组织上。并且，导线移位和脱离是与SCS相关的常见问题。
因此，期望提供一种用于例如导线的可植入装置的更加稳定的锚固系统。该锚固系统应当在期望的位置处提供锚固而不是仅仅沿着被预定用于锚固的装置的位置处提供锚固。这种锚固还应当帮助阻止移位和脱离。这些目的的至少一些将通过本发明得到满足。
发明内容
本发明提供一种用于将医疗装置锚固到特别是椎骨的例如骨或者骨结构的硬组织上的装置、系统和方法。各种医疗装置被用于治疗位于患者体内的骨或者骨结构附近的解剖部分。本发明的装置和系统适于与很多这样的医疗装置以及用于特定治疗的专用装置一起使用。通过将这些装置直接锚固到硬组织周围，这些装置被更加靠近治疗源锚固。这提供了另外的稳定性并减少了装置在治疗部位的移位。同样，通过连接到硬组织而不是软组织，通常能够实现更牢固的连接。
在本发明的第一方面，提供一种用于将元件固定到硬组织的硬组织锚固件。在一些实施方式中，硬组织锚固件包括具有用于穿刺硬组织的形状的穿刺端，和具有孔的头部，其中，孔能够接收穿过它的元件，并且头部能够将元件固定到孔内。通常，元件包括导线，但可以使用导管或者其它装置。
在一些实施方式中，头部包括连接到孔的通道，其中，该通道能够允许元件从头部的外部进入孔。在一些例子中，头部可调以闭合通道，例如通过头部的变形。可选的，头部的变形可以将元件固定到孔内。在一些实施方式中，头部还包括设置在孔内的索环。该索环可帮助将元件保持在孔内。
在一些实施方式中，穿刺端具有渐缩的、锥形的、刻痕的、倒刺的或者锯齿的形状。在这些例子中，硬组织锚固件是钉并被压入到硬组织中。在其它实施方式中，穿刺端具有带螺旋螺纹的柄身。在这些例子中，硬组织锚固件是螺钉并旋转到硬组织中。
在本发明的第二方面，提供一种用于将元件锚固到身体中的硬组织的方法。在一些实施方式中，该方法包括将硬组织锚固件朝硬组织推进，其中，锚固件包括穿刺端和具有孔的头部；将元件定位到孔内以及向头部施加压力以将穿刺端至少部分地驱动到硬组织中。
在一些实施方式中，施加压力包括向头部施加压力以将元件固定到孔内。可选地，施加压力包括使头部变形以借助摩擦将元件固定到孔内。
在一些例子中，该方法还包括将元件植入到身体中。该植入可发生在将元件定位到孔内的定位步骤之前。这允许用现有的植入系统来利用硬组织锚固件。
在另一些实施方式中，锚固件包括连接到孔的通道，所述方法还包括使元件的一部分通过通道到达孔。可选的是，施加压力包括使头部变形以至少部分地闭合通道。
为了输送本发明的硬组织锚固件，该方法可以包括将锚固件的头部安装到施放器的远端。在一些情况下，将硬组织锚固件朝硬组织推进包括将施放器的远端推进通过经皮进入开口。在这些例子中，施放器具有适用于该经皮输送的薄断面。
在一些实施方式中，向头部施加压力包括向施放器施加压力。可选地，向施放器施加压力包括通过施放器的力使头部变形以将元件借助摩擦固定到孔内。
在本发明的第三方面，提供一种用于输送硬组织锚固件的施放器。在一些实施方式中，施放器包括具有近端和远端的细长主体，其中，远端能够接收硬组织锚固件的头部，以及连接到细长主体的近端的手柄，使得施加到手柄的力能够转移到硬组织锚固件的头部。可选地，细长主体的形状用于通过经皮进入开口。
在一些实施方式中，施放器还包括用于将硬组织锚固件从细长主体的远端释放的释放钮。远端可以包括用于接收所述头部的凹陷，硬组织锚固件可以从该凹陷释放。
当硬组织锚固件包括骨钉时，力通常包括能够转移成硬组织锚固件的头部上的向下力的纵向力。当硬组织锚固件包括接骨螺钉时，力通常包括能够转移成硬组织锚固件的头部的旋转的旋转力。在这些例子中，远端包括能够与头部连接的可旋转构件，其中，旋转力使可旋转构件旋转。
附图说明
本发明的其它目的和优点通过以下结合附图的详细描述将变得更加清楚。
图1示出了本发明的与常规的SCS系统一起使用的硬组织锚固件；
图2示出了本发明的与导线一起使用的硬组织锚固件，其中，导线被植入到DRG附近以向其提供选择性刺激；
图3示出了本发明的骨钉的一种实施方式；
图4示出了骨钉的实施例，该骨钉具有一元件，在该元件植入之前该元件旋过其头部；
图5示出了具有沿着头部的顶部的通道的钉的侧视图；
图6示出了图5的钉的俯视图；
图7示出了一元件穿过骨钉的头部中的通道；
图8示出了由定位在骨钉的头部的臂中的硅管围绕的导线；
图9A-9B示出了具有扣眼的骨钉的一种实施方式；
图10示出了具有扣眼的钉，其中，扣眼的通道已经通过头部的卷曲闭合；
图11A、11B、11C、11D分别示出了本发明的骨钉的一种实施方式的正视图、侧视图、俯视图和仰视图；
图12示出了用于将骨钉输送到硬组织的一部分的施放器；
图13示出了具有用于接收骨钉的头部的凹陷的施放器的远端；
图14示出了在经由与扣眼的摩擦配合插入的过程中牢固地固定到施放器的骨钉；
图15A、15B、15C、15D、15E示出了具有能够定位到施放器的远端内的插入件的施放器的细长主体的各种视图；
图16示出了本发明的接骨螺钉的一种实施方式；
图17A、17B、17C、17D、17E示出了接骨螺钉的一种实施方式的各种视图；
图18A-18B示出了用于将接骨螺钉输送到硬组织的一部分的施放器。
具体实施方式
本发明提供用于将医疗装置锚固到特别是椎骨的例如骨或者骨结构的硬组织的装置、系统和方法。各种医疗装置被用于治疗位于患者体内的骨或者骨结构附近的解剖部分。例如，脊髓电刺激器(SCS)沿着脊柱定位以治疗疼痛。图1示出了包括可植入导线100和可植入电源或者可植入脉冲发生器IPG的常规SCS系统。利用荧光透视检查，导线100被植入到脊柱S的硬膜外腔E中并抵靠脊髓的硬脊膜层定位。导线100可借助硬膜外针(用于经皮导线)穿过皮肤植入，或者通过微型椎板切开术(用于浆式导线)直接地和外科地植入。不论哪种情况，导线100都从脊柱S延伸到远程植入的IPG。通常，导线100缝合到远离进入硬膜外腔E的位置处的软组织上。这种缝合常常不足以满足植入的导线100，因此导致移位或者脱离。图1示出了本发明的与常规的SCS系统结合使用的硬组织锚固件600以锚固植入的导线100。如图所示，锚固件600可用于将导线100连接到硬组织，例如在进入硬膜外腔E的位置附近的椎骨V上。这通过固定到更硬的组织提供了更加可靠的锚固并减小了导线的远侧部分和锚固部位之间的距离。这有利于减少导线100的移位和脱离。
另外，本发明的装置、系统和方法可以用于锚固其它类型的医疗装置，特别是用于选择性地刺激尤其是背根或者背根节(DRG)的脊髓解剖结构的各种其它类型的导线。图2示出了植入到DRG附近以向其提供选择性刺激的导线150。2007年12月6日提交的题为“Grouped Leads For Spinal Stimulation”的美国专利申请No.11/952049(律师卷号No.10088-706.201/客户卷号No.SM-00610US)和2007年12月6日提交的题为“Grouped Leads ForPosterior Access Of Directed Spinal Stimulation”的美国专利申请No.11/952053(律师卷号No.10088-707.201/客户卷号No.SM-00710US)中提供了这种导线的实施例，这两个申请都通过引用结合在此。如图所示，本发明的硬组织锚固件600可以用于将导线150锚固到RDG附近的椎骨V的部分上。这使导线150靠近刺激部位锚固并减少了导线150的移位或脱离。
本发明的硬组织锚固件600包括骨钉和接骨螺钉。图3示出了本发明的骨钉601的一种实施方式。骨钉601可以用于将诸如导线或者导管等元件锚固到骨或者骨结构，例如想要应用的部位附近。在该实施方式中，骨钉601具有头部602和与头部602相对的穿刺端604。穿刺端604可以具有所示的适于穿刺骨B的减缩的、锥形的、刻痕的、倒刺的、锯齿的或者其它形状的端部。头部602包括孔607，在元件152植入之前其可以穿过孔607，如图4所示。骨钉601被沿着元件152推进到期望的锚固位置。然后向头部602施加力以将穿刺端604推进到骨B中，由此将元件152在该位置处固定到骨B。这可以在元件150的植入过程中实现。
骨钉601的其它实施方式特别适于在不太期望向元件150上的锚固件预加载时将元件150锚固到锚固位置。在元件150已经被植入或者不可能在元件150上方推进锚固件，例如将锚固件从元件150的一端到锚固位置时就如此。在这些实施方式的一些中，骨钉601的头部602包括连接到孔607的通道608。图5示出了具有沿着头部602的顶部的该通道608的钉601的一种实施方式的侧视图，且图6示出了这种钉601的俯视图。钉601可以通过头部602中的通道608滑动到元件150上，从而元件150通过孔607，如图7所示。由此，钉601可以被定位到沿着元件150的任何位置处。通道608然后可以通过头部602的变形来闭合。头部602的进一步变形使头部602环绕到元件150上，从而阻止相对运动。
图8示出了由定位在骨钉601的头部602的臂614中的硅管612包围的导线610。头部602(至少一个臂614)的变形或者卷曲相对于头部602保持硅管612，且其进一步卷曲相对于硅管612保持导线610。因此，各种程度的变形可用于提供不同的期望结果。
在一些实施方式中，钉601包括索环606，如图9A-9B所示。索环606包括与头部602的通道608对准的通道。因此，元件150可以通过头部602的通道608和索环606的对准通道。索环606帮助向元件150施加摩擦并保护元件150免受可能的损害。头部602的变形和卷曲进一步向元件150施加摩擦，例如将元件150固定到索环606内。图10示出了具有索环606的钉601，其中，索环606的通道已经通过头部602的卷曲闭合。这示出了孔的尺寸的减小并因此增加了与元件150的摩擦。
图11A、11B、11C、11D分别给出了本发明的骨钉601的一种实施方式的正视图、侧视图、俯视图和仰视图。在该实施方式中，钉601具有带有直径为0.040英寸的孔607的直径为0.060英寸的头部602。此外，头部602具有0.008英寸的通道608。该实施方式还包括具有锯齿的穿刺端604，其从0.045英寸宽的第一锯齿渐缩到0.035英寸宽的第二锯齿再到一点。穿刺端604距离孔607的中心的长度为0.105英寸。因此，本发明的骨钉601通常具有较小的尺寸以允许定位在受限并难以到达解剖区域的位置。将会认识到，这些尺寸是示例性的，并且并不意在限制本发明的范围。
头部602和穿刺端604通常由相同的材料形成，并可包括任何生物相容性材料和/或可生物吸收材料，包括但不限于钴铬、钴铬合金、钛、钛合金、不锈钢、可再吸收PGA或PLA，和PEEK。
索环606可由包括但不限于硅或者聚安酯的任何软性的生物相容性和/或可生物吸收材料构成。索环606可以组装或者模制到钉606上。
本发明的骨钉601由机械力、例如敲击或者挤压驱动到骨B的部分中。参照图12，提供施放器620用于将骨钉601输送到骨B的部分。施放器620被设计成使得钉601可通过经皮进入开口输送并借助荧光透视或者其它影像技术定位到锚固位置处。通常，施放器620包括细长主体300，该细长主体300具有薄断面以有助于接近身体内的多个目标位置。细长主体300具有近端302和远端304，其中，远端304被构造成接收硬组织锚固件600。在大部分实施方式中，施放器620还包括连接到细长主体300的近端302上的手柄306。
图13示出了具有用于接收骨钉601的头部602的凹陷624的施放器620的远端304的一种实施方式。在一些实施方式中，骨钉601在借助与索环606的摩擦配合插入的过程中被可靠地固定到施放器620上，如图14所示。通过由施放器620在钉601上施加向下的或者纵向的力，钉601借助穿刺端604被穿刺和锚固到骨B中。因此，施加到手柄306的力能够转移到硬组织锚固件600的头部620并将锚固件600驱动到硬组织中。在一些实施方式中，该力然后还使头部602环绕到通过孔607的元件上。钉601然后可以从施放器620释放，例如用释放钮626。钉601被留下，同时元件穿过孔607。
在一些实施方式中，远端304由插入细长主体300中的插入件构成。图15A-15E示出了具有插入件301的细长主体300的多个视图。通常形成或者加工插入件301使得插入件301和细长主体300一起如期望地接收骨钉601。图15A示出了具有用于接收骨钉601的凹陷624的插入件301的侧视图。这里，凹陷624的深度为0.050英寸且宽度为0.060英寸。图15B示出了长0.105英寸、宽0.28英寸的细长主体300的一种实施方式。图15C示出了显示凹陷624的插入件301的仰视图。插入件301被插入到细长主体300中的狭槽303中，如图15D所示。在该实施方式中，狭槽303深0.105英寸宽0.028英寸。图15E示出了具有凹口305的细长主体300的侧视图。当骨钉601被插入到远端304中，如图14中所示时，骨钉601的孔607露出以允许元件通过。再参照图15E，在该实施方式中，凹口305的宽度为0.033英寸。可以认识到，此处记录的尺寸是示例性的。
此处描述安装本发明的骨钉601的示例方法。在一种实施方式中，本发明的骨钉601安装到上述的施放器620中。当钉601保持在施放器620中时，诸如导线610的元件穿过钉601的孔607。钉601被插入到经皮进入部位，借助荧光透视或者其它影像方法定位目标骨或者骨结构。出于预设的治疗目的，根据需要定位导线610。然后将骨钉601敲击就位，使得穿刺端604足以穿刺目标骨或者骨结构并且头部环绕导线。然后移去施放器620。
因此，本发明的骨钉601可以用于固定各种装置而不使用缝线。此外，这种固定或者锚固可以在经皮手术中实现，而不需要大的手术暴露。并且，特别是将钉插入到骨中的过程中固定导线的可变形头部的使用，这种固定或者锚固能够容易地实现而不需要过度的操作。同样，该动作由施放器的使用来辅助，施放器能够在将钉插入到骨中时保持钉并使头部变形。
图16示出了本发明的接骨螺钉650的一种实施方式。接骨螺钉650也可用于将诸如导线或者导管等元件锚固到期望应用的部位附近的骨或者骨结构。接骨螺钉650具有头部652和与头部652相对的穿刺端654。通常，穿刺端654具有渐缩的柄身，该柄身带有适于回转或者扭曲到骨中的螺旋螺纹。在一些实施方式中，螺纹尤其适用于穿刺皮质骨。与被设计用于穿刺松质骨的螺纹形式相比，皮质骨的螺纹形式通常具有更加精细的节距(每英寸具有更多螺纹)并且更浅。在一些实施方式中，螺旋螺纹具有0.020-0.200英寸、更特别是0.029英寸的节距。通常，穿刺端654是自攻式的并且不需要使用骨丝攻来将接骨螺钉650植入到硬组织中。在一些实施方式中，穿刺端654具有锐角的前端角以辅助自攻，例如60度的前端角。在一些实施方式中，附加楔形物以进一步辅助自攻，例如30度的楔形物。
头部652包括孔657，在元件152以类似于图4的骨钉601的方式植入之前，元件152可以螺旋通过孔657。或者，螺钉650能够通过以类似于图7的骨钉601的方式连接到孔657的头部652中的通道658滑动到元件152的部分上。可选的，接骨螺钉650可包括索环，其具有类似于之前关于骨钉601描述的索环606的特征。
图17A-17E给出了本发明的接骨螺钉650的一种实施方式的各种视图。图17A示出了与图16的接骨螺钉类似的接骨螺钉650的立体图。但在该实施方式中，穿刺端654具有更适于穿刺松质骨的螺纹。图17B示出了图17A的接骨螺钉650的侧视图。在该实施方式中，头部652具有大约0.14英寸的直径，并具有直径为大约0.06英寸的孔657。同样，头部652具有0.03英寸的通道658。穿刺端654距离孔657的中心的长度为0.38英寸，且其直径为大约0.10英寸(如图17E的俯视图中所示)。参照图17C及图17D所示的剖视图，穿刺端654具有带有0.075英寸节距的螺旋螺纹的柄身。因此，本发明的接骨螺钉650通常具有较小的尺寸以允许定位在受限的并且很难到达的解剖区域的位置处。可以认识到，这些尺寸是示例性的并不意在限制本发明的范围。
接骨螺钉650的头部652和穿刺端654通常由相同的材料形成，并可包括任何生物相容性材料和/或可生物吸收材料，包括但不限于钴铬、钴铬合金、钛、钛合金、不锈钢、可再吸收PGA或PLA，和PEEK。
本发明的接骨螺钉650通过旋转力被驱动到例如骨B的一部分的硬组织中。参照图18A-18B，提供施放器660用于将接骨螺钉650输送到骨B的一部分。施放器650被设计成与骨钉施放器620类似，也具有薄断面使得螺钉650能够通过经皮进入开口输送并借助荧光透视或者其它影像技术定位到锚固位置。再次，施放器660通常包括具有近端672和远端662的细长主体670，其中，远端662被构造成接收硬组织锚固件600。在大部分实施方式中，施放器660还包括连接到细长主体670的近端672的手柄。
图18A示出了具有用于接收接骨螺钉650的头部652的凹陷664的施放器660的远端662的一种实施方式。施放器660包括能够与接骨螺钉650连接的可旋转构件661。图18B示出了借助例如与索环的摩擦可靠地固定到可旋转构件661上的接骨螺钉650。螺钉650通过旋转构件661借助穿刺端654的旋转被穿刺并锚固到骨B中。当需要使头部652变形或者卷曲时，可向手柄施加力，并且该力可转移到头部652上，使头部652卷曲到通过孔657的元件上。螺钉650然后可例如利用释放钮从施放器660释放。
扭曲式或者螺钉式穿刺的一个挑战在于孔657的定向取决于螺钉650如何旋入。同样，由于其定向，在输送之后将导线放置到孔657中可能是困难的。这些挑战通过本发明的接骨螺钉650得以克服。接骨螺钉650可以首先在期望的位置处螺旋就位，然后再使例如导线的元件加载通过头部652中的通道。然后将导线推进到期望的位置处用于治疗应用并通过头部652的卷曲固定就位。
尽管出于清楚理解的目的，已经通过说明和实施例对前面的发明进行了详细的描述，但很明显的是，可以使用各种替代方案、修改和等同物，并且上面的描述不应当被用来限制本发明的范围。

Claims (27)

1.一种用于将元件固定到硬组织的硬组织锚固件，包括：
穿刺端，其具有用于穿刺所述硬组织的形状；和
具有孔的头部，其中，所述孔能够接收穿过它的所述元件，并且所述头部能够将所述元件固定到所述孔内。
2.如权利要求1所述的硬组织锚固件，其中，所述元件包括导线。
3.如权利要求1所述的硬组织锚固件，其中，所述头部包括连接到所述孔的通道，所述通道能够允许所述元件从所述头部的外部进入所述孔。
4.如权利要求3所述的硬组织锚固件，其中，所述头部可调以闭合所述通道。
5.如权利要求4所述的硬组织锚固件，其中，所述头部能够通过头部的变形调节。
6.如权利要求5所述的硬组织锚固件，其中，所述头部的变形将所述元件固定到所述孔内。
7.如权利要求1所述的硬组织锚固件，其中，所述头部还包括设置在所述孔内的索环。
8.如权利要求1所述的硬组织锚固件，其中，所述穿刺端具有渐缩的、锥形的、刻痕的、倒刺的或者锯齿的形状。
9.如权利要求1所述的硬组织锚固件，其中，所述穿刺端具有带螺旋螺纹的柄身。
10.一种用于将元件锚固到身体中的硬组织的方法，该方法包括：
将硬组织锚固件朝所述硬组织推进，其中，所述锚固件包括穿刺端和具有孔的头部；
将所述元件定位到所述孔内；和
向所述头部施加压力以将所述穿刺端至少部分地驱动到所述硬组织中。
11.如权利要求10所述的方法，其中，施加压力包括向所述头部施加压力以将所述元件固定到所述孔内。
12.如权利要求11所述的方法，其中，施加压力包括使所述头部变形以借助摩擦将所述元件固定到所述孔内。
13.如权利要求10所述的方法，还包括将所述元件植入到身体中。
14.如权利要求13所述的方法，其中，所述定位的步骤发生在所述植入步骤之后。
15.如权利要求10所述的方法，其中，所述锚固件包括连接到所述孔的通道，所述方法还包括使所述元件的一部分通过所述通道到达所述孔。
16.如权利要求15所述的方法，其中，施加压力包括使所述头部变形以至少部分地闭合所述通道。
17.如权利要求10所述的方法，还包括将所述锚固件的头部安装到施放器的远端。
18.如权利要求17所述的方法，其中，将所述硬组织锚固件朝硬组织推进包括将所述施放器的远端推进通过经皮进入开口。
19.如权利要求17所述的方法，其中，向所述头部施加压力包括向所述施放器施加压力。
20.如权利要求17所述的方法，其中，向所述施放器施加压力包括通过施放器的力使所述头部变形以借助摩擦将所述元件固定到所述孔内。
21.一种用于输送硬组织锚固件的施放器，该施放器包括：
具有近端和远端的细长主体，其中，所述远端能够接收所述硬组织锚固件的头部；和
连接到所述细长主体的所述近端的手柄，使得施加到所述手柄的力能够转移到所述硬组织锚固件的头部。
22.如权利要求21所述的施放器，其中，所述细长主体具有能够通过经皮进入开口的形状。
23.如权利要求21所述的施放器，还包括用于将所述硬组织锚固件从所述细长主体的远端释放的释放钮。
24.如权利要求21所述的施放器，其中，所述远端包括用于接收所述头部的凹陷。
25.如权利要求21所述的施放器，其中，所述力包括纵向力，该纵向力能够转移成硬组织锚固件的头部上的向下力。
26.如权利要求21所述的硬组织锚固件，其中，所述力包括旋转力，该旋转力能够转移成硬组织锚固件的头部的旋转。
27.如权利要求21所述的硬组织锚固件，其中，所述远端包括能够与所述头部连接的可旋转构件，其中，旋转力使所述可旋转构件旋转。
CNA2007800450389A 2006-12-06 2007-12-06 硬组织锚固件和输送装置 Pending CN101573079A (zh)

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US20130345783A1 (en) 2013-12-26
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US20080183221A1 (en) 2008-07-31
US20150343206A1 (en) 2015-12-03
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US8518092B2 (en) 2013-08-27
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