CN101184457A - 植入用于髓核的水凝胶假体的方法和设备 - Google Patents
植入用于髓核的水凝胶假体的方法和设备 Download PDFInfo
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- CN101184457A CN101184457A CNA2006800182022A CN200680018202A CN101184457A CN 101184457 A CN101184457 A CN 101184457A CN A2006800182022 A CNA2006800182022 A CN A2006800182022A CN 200680018202 A CN200680018202 A CN 200680018202A CN 101184457 A CN101184457 A CN 101184457A
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Abstract
用于将伸长的水凝胶假体插入椎间盘的仪器(100)包括插入穿过椎间盘的纤维环以提供到椎间盘的核区域的通道的插管(200)、包装在适合于耦合到该插管的近端的管状容器(300)内的伸长的水凝胶假体以及适合于耦合到该管状容器的近端的流体压力源(400)。用于穿过髓核的插管的方便插入并为水凝胶假体穿过插管的完整和受控通道做准备的辅助仪器在插管的工具包中提供。用于确定要插入的假体的体积的定尺设备(700)包括能够穿过插管插入椎间盘的核区域并在其远端具有气球(704)的导管(702),这种气球能够用可测定电极的流体在椎间盘内膨胀,以确定要注入的水凝胶假体的量。
Description
相关申请的交叉引用
本发明主张于2005年3月29日递交的美国临时专利申请No.60/665,836的优先权,该临时专利申请的全部内容通过参考结合在本发明之中。
技术领域
本发明涉及用于替代或补充椎间盘的髓核的假体,尤其涉及用于将低模量脊髓植入物通过小门(small portal)注入椎间盘的设备。
背景技术
由椎间盘损伤或与年龄有关的退化所导致的慢性背痛通常是下背痛是许多患者所经历的状况。
目前治疗背痛的选择从保守的卧床休息到高度侵入的外科程序,包括脊髓融合和整个椎间盘替换。
人类的椎间盘包括两个主要结构,一种是外或周边腱结构,这种结构称为纤维环或环,另一种是位于纤维环内的通常在中心的区域中的内凝胶髓核。核的退化导致椎间盘的退化和功能的丧失。因此,用于缓解背痛的另一种外科选择是核的替代,而保持环的完整。核替代的目的在于缓解疼痛、恢复椎间盘的健康生理功能并避免环的其它磨损和退化。
由于髓核的凝胶特性,现已提出了利用水凝胶来替代自然髓核,而且也提出了用于这种替代的材料和方法。
水凝胶通常用固态且通常不溶解的亲水性聚合物形成,这种水凝胶在水合状态具有通常呈水膨胀的结构。现已提出设计水凝胶植入物,这些水凝胶植入物可具有类似于自然髓核的机械性能,而且也提出了将这些水凝胶假体植入椎间盘的中心区域中,即正如通常由髓核所占据的腔体中。因此,一直以来需要确定要植入的水凝胶假体的正确的量的方法,以恢复到可能的椎间盘的自然机械性能和行为的程度并将这种水凝胶假体插入。
发明内容
本发明是于2005年5月23日递交的美国专利申请No.11/134,309公开和主张的方面的进一步发展,该专利的全部内容通过参考结合在本发明之中。
根据本发明,椎间盘的髓核可通过将水凝胶注入到椎间盘的髓核区域中来补充或替代。根据本发明的用于伸长的水凝胶假体的插入的仪器包括插入穿过椎间盘的纤维环以提供到椎间盘的核区域的通道的插管、包装在适合于耦合到该插管的近端的管状容器内的伸长的水凝胶假体以及适合于耦合到该管状容器的近端的流体压力源。用于穿过髓核的插管的方便插入并为水凝胶假体穿过插管的完整和受控通道做准备的辅助仪器在插管的工具包中提供。本发明还包括能够穿过插管插入椎间盘的核区域并用可测定体积的流体膨胀以确定要注入椎间盘的髓核区域中的水凝胶假体的量的定尺气球和关联插管。要植入的水凝胶假体的量是在可能的程度上恢复椎间盘的自然机械性能所要求的量。可通过将水凝胶假体植入以填充在椎间盘中自然存在的或外科手术产生的任何腔体或补充椎间盘的自然组织来实现这种恢复,从而将椎间盘的髓核区域和纤维环重新增压。虽然在下面就填充髓核内的腔体对本发明的方法和设备在总体上进行了描述,但将会理解,本发明也适用于扩增如前面所述的那样需要这种扩增的所有情况的椎间盘。
因此,本发明的特征在于提供一种用于伸长的水凝胶假体插入椎间盘的髓核区域中的仪器。出于这种水凝胶的光滑的边界层的原因,这种仪器使伸长的水凝胶假体能够像流体一样流动。
另一种特征在于提供一种用于测定椎间盘的髓核区域中的缺陷或腔体体积以确定要插入椎间盘的髓核区域中的假体体积的仪器。
从下面的对本发明进行的描述和相关的附图就会明白本发明的其它特征。
附图说明
图1示出了根据本发明的设备的全视图,这种设备包括插管、用于伸长的水凝胶假体的管状包装以及用于将流体压力加到假体以将假体注入到椎间盘中的增压注射器。
图2是根据本发明的插管的平面图。
图3是以在图2中示为3-3的方向截取的图2中的插管的端视图。
图4是以在图2中示为4-4截取的图2中的插管的正视截面图。
图5a是图2中的插管的透视图。
图5b示出了图2和图5a中插管的替代实施例的手柄的视图,其中,辅助通路的气孔设有流体耦合构件。
图6是在图5中由圆圈6指明的插管的远端顶端的细节。
图7是用于伸长的水凝胶假体的管状包装的全视图。
图8是与本发明的插管一起使用的钝定距线仪器的侧视图。
图9是以由图8中的9-9指明的方向截取的图8中的钝定距线的端视图。
图10是与本发明的插管一起使用的尖定距线仪器的侧视图。
图11是以由图10中的11-11指明的方向截取的图10中的钝定距线的手柄端的端视图。
图12是以由图10中的12-12指明的方向截取的图10中的钝定距线的尖端的端视图。
图13是本发明的替代实施例的示意性侧视图。
图14是图13中的本发明的替代实施例的插管的侧视图。
图15是图14中的插管的顶端区域的详细分解图。
图16是图13中的本发明的替代实施例的另一个插管的侧视图。
图17是图16中的插管的顶端区域的详细分解图。
图18是与示于图13中的实施例一起使用切割套管的侧视图。
图19是带有图14中的插管的用于操纵图16中的切割套管的设备的示意图。
图20是与图13中的替代实施例一起使用的用于伸长的水凝胶假体的管状包装的示意图。
图21是示于图13中的设备的实施例的示意图,这种设备结合位于插管的远端附近的内部压力变换器。
图22是示出了利用示于图13中的本发明的实施例将伸长的水凝胶假体注入椎间盘的髓核区域中的示意性透视图。
图23是用于测定椎间盘的髓核区域中的缺陷或腔体的体积的定尺气球设备的侧视图。
图24是图23中的定尺气球设备的顶端的细节。
图25是图23中的定尺气球设备的侧视图,且定尺气球在扩大的构造中。
图26是图23中的定尺气球设备的的远端区域的示意性侧视截面图,图中示出了定尺气球在坍缩或泄气构造中。
图27是图23中的定尺气球设备的的远端区域的示意性侧视截面图,图中示出了定尺气球在扩大或充气构造中。
具体实施方式
本发明包括用于将伸长的脊髓植入物通过小门植入到椎间盘中的方法和设备。根据本发明,提供用于确定由要注入的假体填充的腔体或缺陷的体积和用于调节注入体积以对应于所测定的体积的设备。
将参考附图对本发明进行描述。
图1示出了本发明的水凝胶注入设备100的实施例,设备100通常包括插管200、用于供应伸长的水凝胶假体的管状容器300和增压注射器400,管状容器300通常足够地透明以允许看到管状容器300中所容纳的假体并带有标记302,标记302用于确定要注入的假体的长度,这会在下面进行详细描述。
图2至图6详细地示出了插管200。在设备及其器件的描述中会参考使用设备的操作人员使用词语远端和近端,如将水凝胶假体植入椎间盘的髓核区域中的外科医生。
如图2所示,插管200包括主输送通路202、次通路208和手柄212,主输送通路202具有腔管204,腔管204带有锥形端206,次通路208沿着主输送通路202的侧面提供并具有腔管210,手柄212位于插管200的近端。手柄212包括开口214,开口214与辅助腔管210连通以提供通风功能。开口214还可设有用于连接到其它设备的耦合附件(如图5b所示)。手柄212还支撑流体联接器216,流体联接器216与输送腔管流体,以将输送插管连接到用于伸长的水凝胶假体的储存管300。
用于水凝胶假体的储存管300包括通常是透明的管道302,管道302在任一端设有联结器304,这些联结器304用于连接到输送插管200并连接到增压注射器400或其它流体压力源,以从储存管推动假体插管输送插管并进入椎间盘中。管道302足够地透明或半透明或者设有透明或半透明区域如透明或半透明条带或透明或半透明窗口的地点,(未明确指明)以允许对已选量的假体进行测定并监测假体插入过程。优选管道302设有标记308,以像下面所描述的那样便于确定要插入的假体的长度。
增压注射器400通常是常规的注射器,这种类型的注射器设有圆筒402、柱塞404和联结器406。这些注射器通常配有在适当的外壳408中的压力变换器,这种外壳408带有测定压力指示器410。
现对设备100连同辅助仪器钝定距线500和尖定距线600的使用进行描述。
在以征候的常规评估和适当的身体检查为基础对进行外科手术的候选患者进行了适当的选择之后,患者做好进行外科手术的准备。通常采用后侧或后外侧方式。穿过皮肤制成进入切口。由于本发明的假体插入仪器的尺寸相对较小,所以这种进入切口可相对较小。因此,选择钝定距线500(图8)用于这个过程中的下一个步骤。钝定距线500具有轮轴502,确定轮轴502的尺寸以在输送插管200的输送通路202的输送腔管204中滑动配合。轮轴502具有呈锥形但相对较钝的端部504和通常是平坦的或非锥形端部506。下面将对钝定距线500的端部504和506的运行进行描述。在已制成进入切口之后,小心地使轮轴502的钝的锥形端部504穿过组织朝向将要插入假体的椎间盘前行。钝定距线500的前行和定位由适当的成像如荧光检查在进行程序时监测。在程序的这个阶段的带有相对钝的顶端504的钝定距线500的使用便于避免对位于外科手术的一般位置的脆弱的结构造成损害,包括神经、血管等。但钝定距线500的顶端504已到达纤维环的外壁时,就开始程序的下一个步骤。
由于钝定距线500的顶端504靠在纤维环的外壁上,所以将输送插管200配合在钝定距线500的轮轴502上并小心地使输送插管200穿过组织前行直到输送插管200的锥形顶端206到达纤维环的外壁。这样就将钝定距线500移去并开始程序的下一个步骤。
任何对尖定距线600(图10至12)进行选择以用于程序的下一个步骤。尖定距线600具有轮轴602和尖点606,轮轴602带有位于近端的手柄604,尖点606位于远端。构造轮轴602的直径以在输送通路202的输送腔管204中滑动配合。
由于输送插管200的输送腔管206靠在纤维环的外壁上,所以将尖定距线插入输送通路202的输送腔管204中并使尖定距线穿过纤维环前行而进入椎间盘的髓核区域。之后,在尖定距线上方使输送插管前行,直到尖定距线的远端206位于椎间盘的髓核区域中。该程序也通过适当的放射装置或其它监测装置进行。这样就将尖定距线600移去,并留下从身体的外部道髓核区域中的开放通路,以用于程序的其它步骤。
根据髓核的状况,外科医生可继续采取治疗髓核或临近的组织的任何适当的行动。因此,外科医生可继续直接将假体插入或继续进行腔体的外科准备以接收假体。适合于穿过小的开口切除组织的外科工具是常规工具,且任何这些工具如杯活检钳可用于切除组织以准备适当的腔体。在已准备好适当的腔体之后,优选确定由于植入的腔体的尺寸以预先选择伸长的水凝胶假体的正确量。确定体内的腔体的尺寸的方法是公知的,且任何这种方法可用于确定接收假体的腔体的体积。优选将定尺气球插入腔体中并用适当的流体优选液体使气球膨胀,直到将腔体填充,如由相对快速的上升压力、内部压力达到预先确定以指明腔体的满意填充的值和利用不透射线的流体的放射监测等所指明的增加的阻力所指明的那样。这样就确定并记录填充腔体所要求的流体体积,并且将气球缩小并退出。
然后,外科医生穿过插管将一定体积的水凝胶插入,该体积填充等于在前面的步骤中所测定的腔体的体积。虽然外科医生可直接将伸长的水凝胶假体注入,但优选通过下面的程序预先确定要注入的假体的量。将储存管300耦合到无菌场中的增压注射器400等。选择已预载足够的伸长的假体的储存管以在储存管中提供长于填充已准备的腔体所要求的假体的过长。这样就操作增压注射器以挤出过多的假体,并在储存管300中仅留下准确数量的要注入的假体。然后将储存管300的远端耦合到输送插管200的近端,并操作增压注射器400以将假体穿过输送插管200推出储存管300而进入在椎间盘的髓核区域中准备的腔体中。虽然在流体压力下可将伸长的假体的整个长度注入,但优选在要注入的假体的一些即最后的部分留在输送插管中时将注入中断。这样就再次选择钝定距线,并将平坦的或以其它方式并不设计用于解剖的端部506即与钝的解剖端部504相对的端部506插入输送插管200的输送腔管204中,并使端部506前行以将伸长的水凝胶假体的最后部分挤入腔体中,并且确保假体的终端位于腔体中并远离入口孔径,这样就减少后来的假体穿过植入孔径排出的可能性。
然后将插管200和钝定距线500抽出并将外科创口闭合。由于通过本发明的程序在纤维环中形成的插入孔径相对较小,所以外科医生可决定用于该孔径的然后闭合程序是不必要的。外科闭合程序的余下部分是常规的。
用于注入伸长的假体的仪器的替代实施例在图1 3至图22中示出。
图13示出了设备630,设备630包括输送插管632、切割套管(或外插管)636(在图18中示出)和压力发生器648,切割套管636在输送插管632上方与储存管644配合,储存管644适于容纳伸长的水凝胶假体642,压力发生器648可以是增压注射器,如用在前面所描述的本发明的实施例中的增压注射器。
输送插管632具有输送腔管633(用虚线示出),输送插管633在其远端由插塞顶端634闭合,插塞顶端634具有通常呈锥形的顶端,以插入插管椎间盘的纤维环。该输送插管具有侧向朝向的输送孔径650,输送孔径650位于输送插管的远端并通常非常接近于插塞顶端634。优选插塞顶端634设有轴柄635,轴柄635延伸到输送腔管633中且具有直的或弯曲的坡道,以有助于插管侧向孔径650输送假体。输送插管632的近端设有用于将近端耦合到储存管644的联结设备640。
在使用时,实施例630用于将伸长的水凝胶假体插入椎间盘的髓核区域中,以补充已退化的髓核或填充通过其它外科方式尤其是微创外科技术在椎间盘中产生的腔体。通过将容纳伸长的水凝胶假体642的已选储存管644的一端(远端)耦合到输送插管632的近端并接着就流体压力源耦合到储存管644的另一端(近端)来组装注入设备630。然后将切割套管636置于输送插管632上方。然后操作压力发生器648,以使水凝胶假体642从储存管644穿过输送腔管633前行,直到假体642的远端仅出现在侧向输送孔径650中。然后使切割套管636前行,直到切割套管636切割套管636覆盖并保护侧向输送孔径650,然后将输送插管632插入外科手术位置中并穿过纤维环,直到远端顶端634和侧向输送孔径650位于椎间盘的髓核区域中。该程序在通过放射成像等的控制之下进行。然后将该切割套管缩回以露出侧向输送孔径650,并且操作压力发生器648以将伸长的水凝胶假体642挤入椎间盘中的腔体内。当如通过测定从储存管644挤出的量或通过用放射(利用不同辐射的假体)观察植入的量所确定的水凝胶的适当的量已植入椎间盘中时,使切割套管636在侧向输送孔径650上方前行以用于伸长的假体642。然后通过常规程序取下输送插管632并闭合外科手术位置。输送插管632的替代实施例在图16和图17中示出,其中,插管662配有顶端664,顶端664的直径略大于插管662的直径。插管662具有侧向输送孔径670且顶端664设有坡道672,坡道672既可以是弯曲的,如图中所示,也可以是直的。在此实施例中,切割套管636不必具有尖的远端边缘,如在图18中所示出的那样,但可具有可修剪从输送孔径670伸出的水凝胶假体的略钝或方的边缘。图19示出了具有手柄680的设备,这些手柄680夹持输送插管632和切割套管636,以允许外科医生将切割套管636在输送插管632上方前行,以用于从输送孔径650伸出的水凝胶假体。图20示出了假体储存管644,假体储存管644具有标记645,以指明已从储存管644挤出的假体642的长度。图21示出了插管632的另一个替代实施例。在图21的实施例中,插管632设有用于在插入假体时确定椎间盘内压的压力变换器651。在使用插管的这个实施例时,在达到椎间盘内的预定压力时可中止植入。图22示意性地示出了伸长的水凝胶假体645插管纤维环656插入椎间盘的髓核区域中。
图23至图27示出了用于确定腔体的尺寸的优选设备700,这种腔体具有在椎间盘的髓核区域中的可填充体积,以确定要注入的假体的体积。定尺设备700包括膨胀导管702,膨胀导管702具有位于其近端的流体联结器706,且定尺设备700还具有在其远端上的非常一致的气球704。在所示出的实施例中,气球704包围导管的端部,这个端部具有直径减小的远端区域708,以允许气球坍缩到不大于导管702的更近端部分的直径。优选将整个导管和气球组件的尺寸确定为插管设备100的输送插管202的输送腔管204配合。位于导管的近端的流体联结器706适合于附到流体源以使气球704膨胀。优选导管702的远端延伸穿过气球704,且气球704在邻近于导管702的顶端的位置和在直径减小的区域708内的略近位置固定到导管702的直径减小的区域708。用于膨胀定尺气球704的流体穿过导管702的直径减小的区域708中的孔进入和离开气球。不透辐射的标志710位于导管702上,如图24所示,以允许通过放射观察控制将定尺气球704精确地定位于椎间盘中。由于在插入之前将定尺气球704定位于导管702上,所以定尺气球704处于如图26所示的坍缩状态。图27示出了处于完全膨胀或完全增大状态的定尺气球704,其中已将足够的膨胀流体、液体或气体引入,以将气球704膨胀到一种状态,在这种状态中,已将坍缩状态的所有褶皱去除,而且气球704的进一步增大要求气球704的边界曲面或膜的弹性伸长。虽然可将气球进一步增大而超过其完全膨胀状态,但根据本发明,优选选择气球704的尺寸,以使气球704在椎间盘中的腔体内膨胀时在用于确定椎间盘中的腔体等的尺寸的压力下从不达到其完全膨胀状态。因此,在本发明的定尺程序的一个实施例中,将气球膨胀到预定压力,这种压力表明将椎间盘内腔体基本上填充。这种预定压力可在约5至约50磅每平方英寸(psi)的范围内变化,优选从约15psi至约45psi的范围内变化,或者从约25psi至约40psi的范围内变化,或者从约30psi至约40psi的范围内变化。用于估计要注入假体的适当体积的有用压力约为35psi。或者或同时,可用不透辐射的流体来膨胀气球,且可对气球的填充进行射线照相监测,以确定腔体填充的完成。气球必须非常一致,即气球必须经历每个单位的压力变化的相对较大的体积变化。因此,用非常薄的强力柔性合成树脂膜来制成气球。优选的这种材料是聚氨酯,且优选用聚氨酯薄膜制成气球。为了实现定尺气球704的最大一致性,选择气球并安装到具有内部体积的定尺设备700,以使气球像前面所描述的那样不会在椎间盘内膨胀到一种压力时到达其完全膨胀状态,这种压力表明假体的适当体积,这种适当的体积用于在可能的程度上恢复椎间盘的自然机械性能。具有足够的一致性以穿过小的输送导管安装并保形膨胀到椎间盘内腔体等的气球通常应为在位于适当的气球膨胀导管的远端并在以约12mm分开的通常呈平面形的平行板之间延伸时会在以约3psi的内部压力膨胀时到达其完全膨胀状态。预想具有这种一致性的气球在椎间盘内膨胀以填充任何腔体等,气球在椎间盘内达到一种程度,这种程度精确地表明要插入的假体的治疗体积。
在前面就某些实施例对本发明进行了描述之后,本领域中熟练的技术人员就会明白,可进行多种变化和替代,而并不背离本发明的精神或实质性特征。接合这些变化的所有实施例旨在包括在本发明之中。因此,认为目前所公开的内容是示例性的而不是限制性的,本发明的范围由所附的权利要求书指明,且在等同的描述的意义和范围之内的所有变化旨在包括在本发明的范围之中。
Claims (20)
1.一种用于将水凝胶假体插入椎间盘中的仪器,所述仪器包括:
假体输送插管,所述假体输送插管具有适合于插入穿过所述椎间盘的纤维环的远端、近端和在所述近端与所述远端之间延伸的输送腔管;
储存管,所述储存管具有适合于耦合到所述假体输送插管的近端的远端以及近端,所述储存管容纳伸长的水凝胶假体;
流体联结器,所述流体联结器适合于将所述储存管的所述远端耦合到所述假体输送插管的所述近端;
流体压力源,所述流体压力源适合于耦合到所述储存管的所述近端;
流体联结器,所述流体联结器适合于将所述储存管的所述近端耦合到所述流体压力源;以及
压力指示器,所述压力指示器适合于指明所述输送腔管、所述储存管或所述流体压力源内的压力。
2.如权利要求1所述的仪器,其特征在于:所述假体输送插管具有辅助腔管,所述辅助腔管通常从所述近端延伸到所述远端。
3.如权利要求1所述的仪器,其特征在于:所述流体压力源是增压注射器。
4.一种用于将水凝胶假体插入椎间盘中的仪器工具包,所述仪器工具包包括:
假体输送插管,所述假体输送插管具有适合于插入穿过所述椎间盘的纤维环的远端、设有适合于传送所述水凝胶假体的流体联结器的近端和在所述近端与所述远端之间延伸的输送腔管;
第一定距线,确定所述第一定距线的尺寸以具有在所述假体插管的所述输送腔管内的滑动配合并具有第一端部,所述第一端部适合于穿过包围所述椎间盘的组织插入;以及
第二定距线,确定所述第二定距线的尺寸以穿过所述假体插管的所述输送腔管并具有远端,所述远端适合于刺穿所述椎间盘的纤维环。
5.一种用于将水凝胶假体插入椎间盘中的方法,所述方法包括以下步骤:
a)使第一定距线前行穿过包围所述椎间盘的组织,直到所述第一定距线的端部部分接触所述椎间盘的纤维环的外壁;
b)在所述第一定距线的上方使假体插管前行,所述假体插管具有适合于插入穿过所述椎间盘的纤维环的远端、近端和在所述近端与所述远端之间延伸的输送腔管,确定所述输送腔管的尺寸以在所述第一定距线的上方滑动,使所述假体插管前行,直到所述假体插管的所述远端接触所述纤维环的外壁;
c)将所述第一定距线从所述输送腔管卸去;
d)使第二定距线穿过所述输送腔管前行,确定所述第二定距线的尺寸以穿过所述假体插管的所述输送腔管并具有远端,所述远端适合于刺穿所述椎间盘的纤维环,直到所述远端已刺穿所述纤维环并延伸到所述椎间盘的髓核区域中;
e)在所述第二定距线的上方使所述假体插管前行,直到所述假体插管的所述远端延伸到所述椎间盘的髓核区域中;
f)将所述第二定距线从所述输送腔管卸去,从而留下到所述椎间盘的髓核区域中的开放通路;
g)或者穿过所述开放通路将所述髓核组织从所述髓核移去;
h)将储存管的远端耦合到所述假体插管的所述近端,所述储存管容纳伸长的水凝胶假体;
i)将所述储存管的近端耦合到所述流体压力源的源;
j)将所述流体压力加到所述储存管的所述近端,从而推动所述水凝胶假体穿过所述假体输送插管的所述输送腔管并进入所述髓核区域;
k)将所述假体输送插管从所述椎间盘卸去。
6.如权利要求5所述的方法,其特征在于:在步骤h)之前,确定由所述水凝胶假体填充的所述椎间盘内的体积。
7.如权利要求6所述的方法,其特征在于:通过以下步骤确定所述体积:将可膨胀气球插入穿过所述假体输送插管的所述输送腔管;用流体将所述气球膨胀到预定压力;以及确定膨胀所述气球到所述预定压力所要求的所述流体的体积。
8.一种用于确定由水凝胶假体填充的椎间盘内的体积的仪器,所述仪器包括:
膨胀导管,确定所述膨胀导管的至少第一部分的尺寸以插入穿过假体插管的输送腔管,所述膨胀导管具有远端和近端,所述远端和近端适合于耦合到增压流体源;以及
可膨胀气球,所述可膨胀气球固定到所述膨胀导管的所述远端并适合于由所述增压流体源膨胀,
其中:所述可膨胀气球展示出一致性,在用增压后的流体膨胀所述气球时,所述一致性足以基本上保形填充所述椎间盘内的可填充区域。
9.如权利要求8所述的仪器,其特征在于:还包括增压流体源,所述增压流体源能够确定所述增压流体的压力和供应以膨胀所述气球的所述增压流体的体积。
10.如权利要求8所述的仪器,其特征在于:邻近于所述远端的所述膨胀导管的第二部分的直径小于所述第一部分。
11.如权利要求10所述的仪器,其特征在于:所述气球固定到所述膨胀导管的所述第二部分。
12.如权利要求8所述的仪器,其特征在于:还包括至少一个不透辐射的标志,所述至少一个不透辐射的标志位于所述膨胀导管的所述远端附近。
13.如权利要求8所述的仪器,其特征在于:确定所述气球的尺寸,以在用所述增压流体在所述可填充区域中填充时,所述气球并不达到其完全膨胀状态。
14.一种确定椎间盘内的可填充区域的体积的方法,所述方法包括以下步骤:
将处于坍缩状态的气球插入所述可填充区域,
通过将一定数量的增压后的流体引入所述气球直到所述气球内的压力达到预定压力来膨胀所述可填充区域中的所述气球,以及
测定所述增压后的流体的所述数量。
15.如权利要求14所述的方法,其特征在于:所述预定压力在从约5psi至约50psi的范围内。
16.如权利要求14所述的方法,其特征在于:所述预定压力在从约15psi至约45psi的范围内。
17.如权利要求14所述的方法,其特征在于:所述预定压力在从约20psi至约40psi的范围内。
18.如权利要求14所述的方法,其特征在于:所述预定压力在从约30psi至约40psi的范围内。
19.如权利要求14所述的方法,其特征在于:所述预定压力约为35psi。
20.如权利要求14所述的方法,其特征在于:确定所述气球的尺寸,使得在所述气球在所述可填充区域中膨胀时从不达到完全膨胀状态。
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- 2006-03-29 WO PCT/US2006/011454 patent/WO2006105190A2/en active Application Filing
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- 2006-03-29 CN CNA2006800182022A patent/CN101184457A/zh active Pending
- 2006-03-29 BR BRPI0609542-9A patent/BRPI0609542A2/pt not_active Application Discontinuation
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- 2006-03-29 US US11/391,245 patent/US7850730B2/en active Active
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- 2006-03-29 KR KR1020077023393A patent/KR20080002824A/ko not_active Application Discontinuation
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2010
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN111513890A (zh) * | 2020-04-24 | 2020-08-11 | 库诺夫斯私人有限公司 | 一种植入椎间盘纤维环的髓核假体装置及其制造方法和填充装置 |
CN111513890B (zh) * | 2020-04-24 | 2023-10-10 | 库诺夫斯私人有限公司 | 一种植入椎间盘纤维环的髓核假体装置及其制造方法和填充装置 |
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US8475532B2 (en) | 2013-07-02 |
US20110276140A1 (en) | 2011-11-10 |
JP2008534147A (ja) | 2008-08-28 |
EP1865892A2 (en) | 2007-12-19 |
WO2006105190A2 (en) | 2006-10-05 |
WO2006105190A3 (en) | 2007-05-24 |
CA2602858A1 (en) | 2006-10-05 |
KR20080002824A (ko) | 2008-01-04 |
BRPI0609542A2 (pt) | 2011-10-18 |
US20060276802A1 (en) | 2006-12-07 |
US7850730B2 (en) | 2010-12-14 |
AU2006230265A1 (en) | 2006-10-05 |
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