CN104144658B - 用于将生物材料引入到椎骨体的远距离椎间体装置及其使用方法 - Google Patents

用于将生物材料引入到椎骨体的远距离椎间体装置及其使用方法 Download PDF

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CN104144658B
CN104144658B CN201380012459.7A CN201380012459A CN104144658B CN 104144658 B CN104144658 B CN 104144658B CN 201380012459 A CN201380012459 A CN 201380012459A CN 104144658 B CN104144658 B CN 104144658B
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remote
anchoring element
biomaterial
body device
intervertebral
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CN104144658A (zh
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莱科斯劳.F.邱皮克
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LFC SPOLKA z oo
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LFC SPOLKA z oo
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Abstract

一种用于将生物材料引入椎骨体的远距离椎间体装置,为成形本体(1)的形式,其中成形本体包括用于设置在第一椎骨体的终板处的顶部侧(1a),用于设置在第二椎骨体的终板处的底部侧(1b),和形成在顶部侧(1a)和底部侧(1b)之间延伸的外周壁的侧壁(6),其中成形本体(1)设置有至少一个贯通通道(3,4)和至少一个锚定元件(8),所述贯通通道(3,4)具有在侧壁(6)中的从手术径路侧进入的入口孔(5),其特征在于,贯通通道(4)包括用于生物材料的内部贮存室(2),贯通通道(4)穿过锚定元件(8)到存在于锚定元件(8)中的至少一个出口开口(7),并且特征在于,存在用于分配生物材料(3)的分配机构(9)。在使用用于将生物材料引入到椎骨体的远距离椎间体装置的方法中,根据权利要求1到12中任一项所述的远距离椎间体装置在穿过终板的行为过程中,在椎骨体之间穿过至少一个椎骨体的终板,终板由远距离椎间体装置的锚定元件(8)穿孔或切割,并且生物材料(3)被使用分配机构(9)从远距离椎间体装置的贮存室(2)引入到至少一个椎骨体。

Description

用于将生物材料引入到椎骨体的远距离椎间体装置及其使用 方法
技术领域
本发明涉及用于将生物材料引入到椎骨体的远距离椎间体装置(Distanceinterbody device),其设计用于椎骨体的治疗或生物机械支撑。
背景技术
骨治疗系统和方法可从专利申请US2006/0106459得知。所提出的一种系统提供可变形结构,该可变形结构被使用套筒以压缩状态引入到受损的椎骨体的自由空间。该结构在使用材料(可以是固接合剂)将其填充之后扩展,填满受损椎骨的内部部分。该结构具有流通孔,流通孔使该结构沿受控方向扩展。当接合剂粘合时,椎骨体表现(act)像损坏之前一样。
用于骨质疏松修复的骨夯实装置可从专利申请US2005/0124989得知。该装置设置有具有四条细长臂的展开机构。展开机构被以紧凑状态通过插管引入在被治疗的骨中事先制备的孔中。在引入之后,展开机构展开,以增大骨中的腔体。接下来,接合剂通过插管引入到骨中。
柔性细长链植入物及支撑身体组织的方法从专利申请US 2007/0162132得知。该植入物具有链联接本体的形式,优选地具有由骨移植片制成的颗粒的形状。事先使用钻在骨中形成孔,或骨中的腔体被扩大,并且骨质疏松材料被从骨移出。使用插管将柔性细长链植入物引入到骨中的腔体内。植入物填满腔体,支撑椎骨终板,并且恢复适当的椎骨高度。
从专利申请WO2007/140315可知用于将实心颗粒结块和接合剂输送到骨内部以在骨内形成植入物的系统和方法。该系统包括输送插管,其被通过孔引入到内部骨中。插管在其端部上设置有柔性膜,该柔性膜被引入骨内。接下来,使用输送机构,通过插管将实心颗粒和接合剂排出到柔性膜中。该膜扩展并且填满内部骨,并且在结合接合剂之后,恢复骨的正常功能。
上述技术方案的缺点是:
-装置被通过在椎骨体的侧壁中做出另外的孔而直接引入骨中,这造成增加的侵入,
-装置仅用于修复单个椎骨体,不考虑同时治疗具有椎间盘的整个运动节段或椎骨体。
融合装置和融合方法可从专利申请WO2008/140551得知。该装置具有短套管的形式,通常在前表面上开槽,并且在其侧表面上设置有至少一个孔。接合剂通过侧表面中的孔输送,所述接合剂填满该装置的内部并且粘附到椎骨终板,使椎骨固定。
该技术方案的缺点是:
-该装置仅允许椎骨融合,而不可能使用填充材料填满椎骨,并且仅用于填充围绕移除的盘的椎间空间,
-该物质仅融合该装置与邻近的椎骨终板。
椎间体融合的装置和方法可从专利申请WO2005/071190得知。该装置包括成形来放置在两个椎骨之间的主体。该装置设置有与输送通道连接的注射和输送孔。在椎骨中做出至少一个孔之后,材料被注射,并且通过输送通道到达椎骨体,在融合之后使其固定。
发明内容
关于提到的本领域的状态,本发明的第一目的是提供有利的椎间植入物。第二目的是提供将椎间体植入的方法。
该第一目的通过根据权利要求1所述的椎间植入物实现,并且第二目的通过权利要求13中要求保护的方法实现。从属权利要求描述本发明的有利改进。
本发明优于上面提到的现有技术的技术方案的优点是在该装置中提供用于生物材料的分配器。
用于将生物材料引入到椎骨体的远距离椎间体装置没有上面提到的现有技术的技术方案的不便之处,在该远距离椎间体装置中,根据本发明,贯穿通道穿过锚定元件,锚定元件设置有出口孔。该装置设置有至少一个用于生物材料的分配器和引出(施用)生物材料的机构。
通常,至少一个锚定元件位于形成本体的顶部侧,和/或至少一个锚定元件位于成形本体的底部侧。
至少一个锚定元件可包括相对比彼此以锐角延伸的侧面,和侧面彼此相交处的边缘部,其中至少一个出口开口位于边缘部中。替代地或另外,至少一个出口开口可位于侧面中。
优选地,锚定元件滑出该装置。
优选地,锚定元件平行于该装置的纵向轴线或相对于该装置的纵向轴线以锐角设置。
锚定元件可包括切割刀,切割刀位于成形本体的顶部侧或底部侧邻接成形本体的外周壁处。如果切割刀在该装置运动以将锚定元件引入到骨组织中时是锚定元件的前导元件(leading element),则该切割刀利于锚定元件引入到骨组织中。
锚定元件可设置有突出部,该突出部伸出在出口开口上方。这样的突出部可有助于防止出口孔被骨组织阻塞。
优选地,引出(施用)机构是活塞机构,楔机构,或螺杆(蜗杆)机构。
在根据本发明的使用用于将生物材料引入椎骨体的远距离椎间体装置的方法中,在穿过终板的行为过程中,终板由该装置的锚定元件穿孔。生物材料被从远距离椎间体装置的分配器(料盒)使用引出(施用)机构引入到至少一个椎骨体。
优选地,由平行于远距离椎间体装置的纵向轴线设置的锚定元件、通过在椎骨体之间滑动该装置、切割至少一个椎骨体的终板而将椎骨终板穿孔,其中在远距离装置引入在椎骨体之间的过程中,其具有至少一个锚定元件的壁的每一个平行于由椎骨终板形成的表面。
优选地,椎骨终板通过锚定元件滑离远距离椎间体装置、切割至少一个椎骨体的终板被穿孔,其中在远距离椎间体装置引入在椎骨体之间的过程中,其具有锚定元件的壁的每一个平行于由椎骨终板形成的表面。
优选地,使用关于远距离椎间体装置的纵向轴线成锐角设置的锚定元件、通过围绕纵向轴线旋转该装置90°、切割至少一个终板而将椎骨终板穿孔,其中在远距离椎间体装置引入在椎骨体之间过程中,其具有至少一个锚定元件的壁的每一个垂直于由椎骨终板形成的表面。
根据本发明的技术方案的优点是:
提供具有材料分配器的装置,
可在引出机构返回到初始位置之后将分配器另外加料,而无需将该装置撤出椎间空间,
可治疗整个运动区段(motion segment),不仅是单个椎骨。
附图说明
将基于附图说明用于将生物材料引入椎骨主体的远距离椎间体装置及其使用方法,附图中
图1以剖视图示出具有两个关于装置的纵向轴线平行设置的锚定元件,并且引出机构为活塞机构,
图2以剖视图示出具有滑出本体之外的一个锚定元件和楔引出机构的装置,
图3以剖视图示出具有四个关于装置的纵向轴线成锐角设置的锚定元件,并且具有螺杆(蜗杆)引出机构的装置,
图4示出图1中所示的实施例的修改形式,
图5示出图2中所示的实施例的修改形式,
图6示出图3中所示的实施例的第一修改形式,并且
图7示出图3中所示的实施例的第二修改形式。
具体实施方式
用于将生物材料引入到椎骨体的远距离椎间体装置可被认为是成形本体1形式的椎间植入物。成形本体1包括用于放置在第一椎骨体的终板处的顶部侧1a,和用于放置在第二椎骨体的终板处的底部侧1b。外周壁或侧壁6延伸在顶部侧1a和底部侧1b之间,并且形成成形本体1的侧壁。
至少一个锚定元件8a位于顶部侧处,并且至少一个锚定元件8b位于底部侧处。但是,还可能两个或多个锚定元件8a,8b存在于顶部侧1a处和/或底部侧1b处。而且,还可设想的是,仅顶部侧和底壁侧中的一个配备有至少一个锚定元件,虽然优选在顶部侧1a处和底部侧1b处都具有锚定元件。
在成形本体1内部,具有生物材料贮存室。因此,成形本体1提供生物材料3的分配器2。生物材料3可以是例如生物相容PMMA聚合物形式的接合剂,其在注射期间是柔和/软的,并且在引入到椎骨体之后硬化。贯通通道4通过分配器2,该贯通通道4设置有生物材料3通过其被引入到椎骨体的、在侧壁6中的入口孔5和出口孔7。而且,贮存室由贯通通道的增大部分形成。贯通通道4穿过锚定元件8,并且出口孔7设置于锚定元件8中。
图1中所示的装置为本发明的第一实施例。该实施例设置有平行于装置的纵向轴线A设置的两个锚定元件8。每一个锚定元件8包括侧面8a和边缘部8b,侧面8a相对于彼此以锐角延伸,并且边缘部8b通过侧面8a相汇合形成。用于生物材料3的至少一个出口开口7位于边缘部8b中。但是,另外或可替代地,至少一个出口开口可存在于锚定元件8的侧面8a中,或甚至在两个侧面中。其中另外的出口开口7a存在于锚定元件的侧面8a中的第一实施例的修改形式显示在图4中。
生物材料3的引出机构9是活塞机构,该活塞机构包括压头(throng)10和活塞杆11。活塞11是中空的,并且配备有入口孔12,入口孔12通过柱塞13闭合。在装置引入在椎骨体之间之前,分配器2被使用生物材料3通过中空活塞杆11填充。接下来,该装置被插入在椎骨体之间,以使其具有锚定元件8的壁平行于椎骨终板的表面移动。在该装置引入椎骨体之间之后,其锚定元件8没入椎骨终板中深达在活塞杆11从分配器2移开之后,使用引出机构9引出的生物材料3移动通过椎骨体的出口孔7到椎骨体。
远距离椎间体装置的第二实施例显示在图2中。与第一实施例类似,成形本体1包括用于放置在第一椎骨体的终板处的顶部侧1a,和用于放置在第二椎骨体的终板处的底部侧1b。外周壁或侧壁6延伸在顶部侧1a和底部侧1b之间,并且形成成形本体1的侧壁。
与第一实施例的远距离椎间体装置不同之处在于,在图2中所示的第二实施例的装置中,锚定元件8滑出,并且生物材料3的引出机构9为楔机构,该楔机构包括楔块14和驱动元件15,该驱动元件15能够在该装置内移动楔块14。该装置在其侧壁6中具有两个入口孔5,该入口孔5由柱塞13闭合。该装置被引入在椎骨体之间,以使具有锚定元件8的每一个壁沿椎骨终板移动。在将该装置引入在椎骨体之间之后,在本实施例中为螺杆形式的驱动元件15驱动楔块14,所述楔块14在本实施例中配备有与螺杆配合的螺纹。通过该构造,旋转螺杆使楔块朝向具有两个入口孔5的侧壁6移动。因此,楔块14造成,其壁16迫使锚定元件8滑出该装置。另外,将楔块14朝向具有两个入口孔5的侧壁6运动减小贮存室中的空间,并且因此将生物材料3推出出口孔,同时锚定元件8滑出成形本体1。因此,锚定元件8穿过椎骨终板,生物材料3被从分配器2通过出口孔7引入椎骨体。
虽然在本实施例中生物材料3被引入椎骨体,同时锚定元件8被运动出成形本体,但是还可能的是,具有将锚定元件8运动出成形本体1以及将生物材料3推出出口孔7的两种不同机构。如果存在用于将锚定元件8运动出成形本体1以及用于将生物材料3推出出口孔7的不同机构,则分配器可在锚定元件8已经被运动出成形本体1之后被填充。与此相反,当仅存在用于同时将楔块14运动出成形本体1并用于将生物材料3推出出口孔7的一种机构时,贮存室在楔块14被运动出成形本体1之前填充。
虽然在本实施例中仅具有一个锚定元件8,该锚定元件8被运动出成形本体1的顶部壁1a,但是可具有不止一个这样的锚定元件8。特别地,可具有可运动出成形本体1的顶部壁1a的一个锚定元件8和可运动出成形本体1的底部壁1b的另一个锚定元件8。特别地,还可具有可运动出成形本体1的顶部壁1a的不止一个锚定元件8和/或可运动出成形本体1的底部壁1b的不止一个锚定元件8。另外,不可运动的其他的锚定元件可存在于成形本体1的顶壁1a上和/或存在于成形本体1的底部壁1b上。具有可运动出成形本体1的顶部壁1a的两个锚定元件8并具有位于成形本体1的顶部壁1a上的另外的锚定元件8c,8d的修改的实施例显示在图5中。作为另外的锚定元件,在顶部壁1a上存在边缘部8c和尖头8d。请注意,成形本体还可包括可运动出底部壁的一个或多个锚定元件和/或位于底部壁上的另外的锚定元件8c,8d。
远距离椎间体装置的第三实施例显示在图3中。与第一实施例类似,成形本体1包括用于放置在第一椎骨体的终板处的顶部侧1a,和用于放置在第二椎骨体的终板处的底部侧1b。外周壁或侧壁6延伸在顶部侧1a和底部侧1b之间,并且形成成形本体1的侧壁。
图3所示的装置具有关于装置的纵向轴线A成约75°角设置的锚定元件8。这些锚定元件形成螺旋状结构的部分。生物材料3的引出机构9是螺杆/蜗杆机构,包括螺杆17和驱动辊18。入口孔5由旋钮13闭合。该装置在生物材料3处于分配器2中的情况下被引入在椎骨体之间,以使其具有锚定元件8的壁垂直于由椎骨终板形成的表面。在该装置被引入之后,其被围绕装置的纵向轴线A旋转约90°,这使锚定元件8没入锥形终板中。驱动辊18的旋转将生物材料3通过出口孔7传送到椎骨体。
为了支持椎骨终板切入骨组织中,每一个锚定元件8可包括切割刀8e,如图6中所示,图6以剖视图显示了图3中所示的实施例的修改形式。请注意,图6的截面垂直于图3的横截面延伸。这样的切割刀有利地位于成形本体1的顶部侧1a或底部侧1b与外周壁6邻接处。
为了防止出口孔7在远距离椎间体装置插入过程中被骨组织阻塞,锚定元件可设置有突出部,所述突出部伸出在出口开口7上方。在图6中所示的实施例中,突出部由边缘部8b的突出部分8f形成,所述突出部分沿远距离椎间体装置植入在两个椎骨终板之间的过程中的旋转方向R在出口孔7之前。该突出部分8f在出口开口7的沿旋转方向R的后方的边缘部部分上方伸出距离d。通过该测量,通过旋转远距离椎间体装置在椎骨终板的骨组织中提供的切割深度大于出口开口7后面的边缘部部分的长度。因此,出口开口7后面的边缘部部分不延伸到切口的底部,因此出口开口不会由骨组织阻塞。相反,切口形成用于生物材料3的通道。上述突出部分8f可还存在于图1和4中所示的实施例的锚定元件8的边缘部8b中。
在图3中所示的实施例的又一修改形式或图6中所示的实施例的修改形式中,一个或多个另外的出口开口7可存在于锚定元件8的至少一个侧面8a中。这样的修改形式显示在图7中。
下面的条款是本发明的非详尽总结:
1、用于将生物材料引入到椎骨体的远距离椎间体装置,为成形本体的形式,该成形本体设置有至少一个贯通通道和至少一个锚定元件,该贯通通道具有从手术径路侧进入的、侧壁中的入口孔,该远距离椎间体装置的特征在于,
贯通通道(4)穿过锚定元件(8),锚定元件(8)设置有通孔(7);
设置有至少一个用于生物材料(3)的分配器(料盒)(2),和引出(施用)生物材料(3)的机构(9)。
2、根据条款1的远距离椎间体装置,其特征在于,锚定元件(8)滑出(可滑出)该装置。
3、根据条款1的远距离椎间体装置,其特征在于,锚定元件(8)平行于该装置的纵向轴线(A)设置。
4、根据条款1的远距离椎间体装置,其特征在于,锚定元件(8)相对于该装置的纵向轴线(A)成锐角设置。
5、根据条款1的远距离椎间体装置,其特征在于,引出(施用)机构(9)为活塞机构。
6、根据条款1的远距离椎间体装置,其特征在于,引出(施用)机构(9)为楔机构。
7、根据条款1的远距离椎间体装置,其特征在于,引出(施用)机构(9)为螺杆(蜗杆)机构。
8、一种使用用于将生物材料引入椎骨体的远距离椎间体装置的方法,其中远距离椎间体装置被引入在椎骨体之间,远距离椎间体装置设置有至少一个贯通通道;接下来,生物材料被穿过至少一个椎骨体的终板引入,
其中,
在穿过终板的行为过程中,终板被条款1-7中限定的装置的锚定元件(8)穿孔,并且生物材料(3)被使用引出(施用)机构(9)从远距离椎间体装置的分配器(料盒)(2)引入到至少一个椎骨体。
9、根据条款8的方法,
其中,
由平行于远距离椎间体装置的纵向轴线(A)设置的锚定元件(8)通过在椎骨体之间移动远距离椎间体装置、切割至少一个椎骨体的终板而将椎骨终板穿孔,其中在远距离椎间体装置引入在椎骨体之间的过程中,其具有锚定元件(8)的壁的每一个平行于由椎骨终板形成的表面。
10、根据条款8的方法,
其中,
椎骨终板通过将锚定元件(8)滑出远距离椎间体装置、切割至少一个椎骨体的终板而被穿孔,其中在远距离椎间体装置引入椎骨体之间过程中,其具有锚定元件(8)的壁的每一个平行于由椎骨终板形成的表面。
11、根据条款8的方法,
其中,
使用关于远距离椎间体装置的纵向轴线(A)成锐角设置的锚定元件(8),通过围绕纵向轴线(A)旋转该装置90°、切割至少一个椎骨体的终板而将椎骨终板穿孔,其中在远距离椎间体装置引入椎骨体之间过程中,其具有至少一个锚定元件(8)的壁的每一个垂直于由椎骨终板形成的表面。

Claims (13)

1.一种用于将生物材料引入到椎骨体的远距离椎间体装置,为成形本体(1)的形式,其中成形本体包括用于设置在第一椎骨体的终板处的顶部侧(1a)、用于设置在第二椎骨体的终板处的底部侧(1b)、和形成在顶部侧(1a)和底部侧(1b)之间延伸的外周壁的侧壁(6),其中成形本体(1)设置有至少一个贯通通道(3,4)和至少一个锚定元件(8),所述贯通通道(3,4)具有从手术径路侧进入的侧壁(6)中的入口孔(5),
贯通通道(4)穿过锚定元件(8)到存在于锚定元件(8)中的至少一个出口开口(7),
其特征在于,
贯通通道(4)包括填充了生物材料的内部贮存室,和
分配机构(2),位于贮存室中,以作用于贮存室中的生物材料,以用于分配生物材料;
远距离椎间体装置包括引出机构(9),其允许施用生物材料。
2.根据权利要求1所述的远距离椎间体装置,其中至少一个锚定元件位于成形本体(1)的顶部侧(1a)处,且/或至少一个锚定元件(8)位于成形本体(1)的底部侧(1a)处。
3.根据权利要求1或2所述的远距离椎间体装置,其特征在于,至少一个锚定元件(8)包括相对于彼此以锐角延伸的侧面(8a)、和侧面(8a)彼此相交处的边缘部(8b),并且至少一个出口开口(7)位于边缘部(8b)中。
4.根据权利要求1或2所述的远距离椎间体装置,其特征在于,至少一个锚定元件(8)包括相对于彼此以锐角延伸的侧面(8a)、和侧面(8a)彼此相交的位置处的边缘部(8b),并且至少一个出口开口(7)位于侧面(8a)中。
5.根据权利要求1或2所述的远距离椎间体装置,其特征在于,至少一个锚定元件(8)在成形本体(1)中布置为其可滑出成形本体(1)。
6.根据权利要求1或2所述的远距离椎间体装置,其特征在于,锚定元件(8)平行于该装置的纵向轴线(A)设置。
7.根据权利要求1或2所述的远距离椎间体装置,其特征在于,锚定元件(8)相对于该装置的纵向轴线(A)以锐角设置。
8.根据权利要求1或2所述的远距离椎间体装置,其特征在于,锚定元件(8)在成形本体(1)的顶部侧(1a)或底部侧(1b)邻接成形本体(1)的外周壁的位置处包括切割刀(8e)。
9.根据权利要求1或2所述的远距离椎间体装置,其特征在于,引出机构(9)为活塞机构。
10.根据权利要求1或2所述的远距离椎间体装置,其特征在于,引出机构(9)是楔机构。
11.根据权利要求1或2所述的远距离椎间体装置,其特征在于,引出机构(9)是螺杆机构。
12.根据权利要求1或2所述的远距离椎间体装置,其特征在于,锚定元件(8)设置有突出部(8f),该突出部(8f)伸出在出口开口(7)上方。
13.一种用于将生物材料引入到椎骨体的远距离椎间体装置,其为成形本体的形式,设置有至少一个贯通通道和至少一个锚定元件,所述贯通通道具有从手术径路侧进入的、侧壁中的入口孔,贯通通道(4)穿过锚定元件(8),锚定元件(8)设置有通孔(7),其特征在于,
贯通通道(4)包括填充了生物材料的内部贮存室,和
远距离椎间体装置包括分配机构(2),位于贮存室中,以作用于贮存室中的生物材料,以用于分配生物材料;
包括远距离椎间体装置包括引出机构(9),其允许施用生物材料。
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EP2822511A1 (en) 2015-01-14
PL398316A1 (pl) 2013-09-16
WO2013133729A1 (en) 2013-09-12
US10299936B2 (en) 2019-05-28
PL219189B1 (pl) 2015-03-31
CN104144658A (zh) 2014-11-12
US20150066031A1 (en) 2015-03-05
EP2822511B1 (en) 2019-05-01

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