CN104042366B - 矫形可扩张装置 - Google Patents

矫形可扩张装置 Download PDF

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Publication number
CN104042366B
CN104042366B CN201410145229.4A CN201410145229A CN104042366B CN 104042366 B CN104042366 B CN 104042366B CN 201410145229 A CN201410145229 A CN 201410145229A CN 104042366 B CN104042366 B CN 104042366B
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CN
China
Prior art keywords
linkage element
supporting plate
bone device
expansible
lower supporting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CN201410145229.4A
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English (en)
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CN104042366A (zh
Inventor
马克·M·莱维
依兰·伊莎
贾法尔·赫莱希尔
希蒙·斯佩克特
尼姆罗德·米勒
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Expanding Orthopedics Inc
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Expanding Orthopedics Inc
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Publication of CN104042366A publication Critical patent/CN104042366A/zh
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Expired - Fee Related legal-status Critical Current
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Classifications

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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Abstract

本发明提供一种矫形可扩张骨装置，包括绕铰链彼此枢转地连接的多个链接元件，其中每个链接元件具有上支撑板和下支撑板。扩张机构可操作地连接到链接元件，并能使上支撑板相对于下支撑板移动靠近或远离下支撑板。

Description

矫形可扩张装置
技术领域
本发明大体涉及医疗装置，并且更尤其涉及用于加固或支撑体内骨结构的可植入装置，例如但不限于用于稳定人体脊椎的椎间或椎内装置。
背景技术
植入装置例如椎间隔物、椎内或椎间融合装置和椎间盘置换装置已经被发展用于帮助脊椎的稳定和固定或功能性支撑。实例包括不同规格和结构的预组装的环、笼、箱、销和楔，诸如网格或板、可移动盘表面、凝胶或聚合物间隔物、弹性体和结构。然而，所有现有的装置具有一定的缺点，诸如难以构造、插入、体积大、在面积和／或高度上不充分的表面覆盖、多规格(库存)以及其它。
Levy等的PCT／US2012／045495描述了作为可扩张笼在脊柱内使用的装置，所述装置用于脊柱融合并且用于椎骨内VCF(椎骨的压缩性骨折)修复。其它实施例作为椎间盘置换装置使用，允许移动的动态应用。装置包括通过导丝递送的MIS(微创手术)／插管(或非插管)装置，其具有用于控制高度的可扩张性能(以恢复盘间隙高度或椎体高度)。一些装置包括连接得像列车一样的单元，所述装置安装有递送系统，递送系统可被操纵用于定位或按次序地部署一个或更多个单元或用于整体部署该“列车”。所述列车型单元可以是闭式结构(例如闭环状的套筒或管)或开放结构。
发明内容
本发明的试图提供新型的用于加固或支撑体内的骨结构的可植入装置，例如但不限于椎内或椎间融合装置，如下面进一步详细描述的。装置包括在PCT／US2012／045495的装置中未发现的特征，并且能用于与那些装置类似的操作中。
在本发明的一个实施例中，装置能够仅穿过椎骨的一侧(或在盘间隙中)以微创的方式(但在两侧输送也是可行的)安装。材料包括但不限于：硬的或软的、非可吸收的、可吸收的、天然的或人造的、生物的、混合的、包括金属的聚合物、骨质物(同种移植物或其它)、PEEK(聚醚醚酮)、PEKK(聚醚酮酮)、PEK(聚醚酮)、细胞、组织培养产物、PET(聚对苯二甲酸乙二醇酯)、尼龙、涤纶(DACRON)、凯芙拉(KEVLAR)、PE(聚乙烯)、PTFE(聚四氟乙烯)、聚酯、记忆合金或聚合物、PMMA(聚(甲基丙烯酸甲酯))等或其组合。
在另一实施例中，当椎体的前壁和侧壁内发生前楔形压缩性骨折时，该结构能够通过一侧安装并保持打开，但定位在碎骨皮质壁附近，以重建失去的原始椎骨结构。取决于期望的应用，那些实施例中的任何实施例可包括附加的方法或附件，以进一步将所述装置连接到骨(不同于表面接触)，允许独立的静态或动态的功能。
本发明的装置在除脊柱外的骨骼的其它部分的骨中具有其它作用。例如，装置能够在不同骨位置中用作骨间隔物／填料，并且也能够在尝试融合或关节固定或用于骨重建时被引入在骨或关节间隙之间。如另一个实例，在动态应用中，装置能够用作MIS(微创手术)临时或明确的全关节置换装置、部分关节置换装置、关节间隔物或半月板置换装置。装置能够与骨移植物、生物骨接合剂、骨替代物、凝胶、聚合物、PMMA或其组合等一起使用，以增强到骨表面的附接。
在本发明的一个实施例中，可扩张骨装置位于两个椎骨之间，用作椎间盘的替代物，诸如在融合过程中。可扩张骨装置作为间隔物，间隔物在融合时增强融合构造稳定性并且促进前骨柱的连续性。装置被通过小入口引入(微创)，其减少外科手术的创伤并且最大限度地减少覆盖所有的规格和等级的需要库存。一旦定位，装置在高度上扩张以最优适配在盘间隙中。
可扩张骨装置包括两个或更多个链接元件，所述两个或更多个链接元件能够以直角的或稍具角度的排列插入，并且然后通过单独元件的被动、主动或自动控制而调整至骨骼外形(例如，盘间隙)。链接元件能够具有不同的规格(包括对称和不对称的元件组合)以适应不同的骨骼(例如，盘的不同规格)并且用于链接元件的较高或较低的扩张。本发明的装置可以可选地通过附加的螺钉固定到椎体(或体内其它结构)或为独立装置(例如，没有附加的椎弓根螺钉)。
链接件可以是：铰链；弹性或塑性变形的弯曲部分；带有对称或不对称臂的X形剪或链接件，；或元件之间的其它连接类型。元件的铰接程度提供元件在水平平面内的尺寸调整(包括扩张、收缩及弯曲或卷曲)。在实现期望的连接后，机械块或停止件被设置用于将已连接的构造锁定到位。
在本发明的一个实施例中，在装置中形成孔口或窗口，例如但不限于：在装置的顶板和底板中，在装置的侧壁及近侧末端和远侧末端中。骨移植物或骨替代材料能够在移植前通过那些窗口塞进装置内，骨移植物或骨替换材料最终与椎骨融合。如果采用导丝将装置初始地放置在盘间隙中，能够使用装置近侧末端和远侧末端处的窗口。
在本发明的一个实施例中，引导元件(即，第一个进入患者体内的导入位置的元件)的前端面具有锥形的或倒角的鼻，以便于装置插入到盘间隙或其它体腔中。装置的最后一个元件具有允许工具(例如，插入工具、扩张工具等)附接和通过的特征。
本发明提供不同的方法和结构，用于使互相连接的元件扩张。非限制性的实例包括：球囊或千斤顶(例如，螺旋千斤顶或剪形千斤顶)；具有一个或更多个啮合齿轮或小齿轮的传动装置；非对称的转动螺栓；弹性变形致动器(形状记忆合金、人造橡胶或具有适当高延伸比率的任何材料)；塑性变形致动器(作为可扩张器具)；楔元件；液压或气压元件；正时皮带；通过体温激活的自扩张元件(例如，由镍钛诺(NITINOL)制成)；或能够永久附接到元件或可移除的任何其它机构。
扩张能够是平行的，在装置的上部和下部之间产生高度一致的扩张。替代地，扩张能够是平行的，但是如果板被制造为不同厚度，则扩张后的最终形状能够在放置和扩张后在装置的前部和后部之间产生微小的角度，模拟某些椎间盘的自然角度(例如，L5-S1)。替代地，扩张能够是非平行和／或非对称的，例如仅通过在装置的单个点／区域扩张，通常为放置链接件的位置，从而产生相对前后面具有微小角度的扩张(如在L5-S1中)。非对称板和非对称扩张的组合也被该应用的范围覆盖。另一种可行的扩张是对称的在两个连接的链接物的枢轴处，链接物在它们的中央处连接(在它们之间产生X形)。
同样在脊柱盘的情况下，该结构能够通过盘间隙的一侧插入，并且上支撑板和下支撑板的任一个或两个可以包括附加的附接结构(例如但不限于：安装孔、凸耳或突片等，用于螺钉或其它紧固件)，以作为独立装置附接到椎骨的上部和下部，用于静态地融合或动态地允许期望的移动。
在本发明的一个实施例中，可扩张骨装置能够是可靠的(positive)自锁可扩张骨装置。例如，在扩张到需要的高度后，装置能够通过棘轮机构锁定到位。棘轮结构可以附接到元件壁，并且在期望的高度处产生可靠的锁定。棘轮结构提供高度上小增量，其容易被使用者控制。
在本发明的一个实施例中，可以通过将移动部件封闭使得它们在固定的凹形壳内平滑地滑动来避免机械卡死。另外地或替代地，一个或更多个引导件能够用来引导部件的移动并且防止卡死。如果棘轮和引导件一起使用，则引导件的内部自由端或某些其它工具能够用来释放棘轮，例如，通过向外或向内推动棘轮以便使棘轮脱离并允许装置塌陷到其初始位置，或通过与棘轮啮合的壁的弹性变形，由此从壁释放棘轮。如果采用棘轮，则可以将横梁加入到在装置内壁的自由端之间以避免装置中央的塌陷，塌陷将导致棘轮的脱离。
作为另一个实例，在扩张到需要的高度后，装置能够通过固定千斤顶或千斤顶和棘轮机构的组合锁定到位。千斤顶-棘轮扩张机构与对称或非对称扩张的组合在该应用的范围内。
附图说明
从结合附图的以下详细描述，将更充分地理解和领会本发明，其中：
图1A和1B是根据本发明的另一实施例构造和操作的在收缩取向上的可扩张骨装置的简图；
图1C和1D是在扩张取向上的可扩张骨装置简图(使用楔机构)；
图1E和1F是根据本发明的实施例构造和操作的使用另一楔机构的可扩张骨装置的简图和剖视图；
图2A和2B是根据本发明的另一实施例的用于扩张可扩张骨装置的另一机构(球囊)的简图；
图3是根据本发明的另一实施例的用于扩张可扩张骨装置的另一机构(千斤顶)的简图；
图4A和4B是根据本发明的另一实施例构造和操作的在收缩取向上的可扩张骨装置的简图；
图5A和5B分别是根据本发明的实施例构造和操作的使用万向接头机构的力传递机构的简图和分解图；
图5C是图5A和5B的链接元件在盘间隙中的简图；和
图6A，6B和6C是根据本发明的另一实施例构造和操作的使用蜗轮机构的力传递机构的简图。
具体实施方式
现参考图1A-1D，其图示了根据本发明的实施例构造和操作的在收缩取向上(图1A-1B)和扩张取向(图1C和1D)上的可扩张骨装置10。
可扩张骨装置10包括多个链接元件12，所述多个链接元件12中的每个链接元件包括上支撑板14A和下支撑板14B，在该实施例中，链接元件可通过中间楔机构16扩张，如下面进一步描述的。邻近的链接元件12通过铰链18彼此枢转地连接。
在一个实施例中，楔机构16包括任何合适规格和形状的块20，块20被布置为在斜面22上滑动，斜面22被形成在链接元件12中的一个链接元件中。块20连接到丝或其它细长元件24，该细长元件24卷绕铰链18并缠在齿轮传动28的轴26上。齿轮传动28能够通过适当的致动器(未显示)诸如齿轮马达旋转。通过齿轮传动28的适当旋转，细长元件24缠绕轴26并将块20拉到斜道22上。这导致上支撑板14A相对下支撑板14B升高，如图1C和1D所示。齿轮传动28在相反方向上的旋转使得上支撑板14A朝下支撑板14B降低。
链接元件12能够以直角或稍具角度的队列(alignment)插入，并且然后能够通过单独元件的主动或自动控制而被调整至骨骼外形(例如，盘间隙(。铰链18能够是棘轮以帮助保持链接元件12的角度取向。
在本发明的一个实施例中，在装置10中形成孔口或窗口30，例如但不限于：在上支撑板14A和下支撑板14B中，在装置的侧壁及近侧末端和远侧末端中。骨移植物或骨替换材料能够在植入前通过那些窗口塞进装置内，骨移植物或骨替换材料最终与椎骨融合。
在本发明的一个实施例中，该对链接元件12的近端面和远端面是锥形的、倒角的或倒圆角的，以便于装置插入进到盘间隙或其它体腔中。
在本发明的一个实施例中，可扩张骨装置10具有棘轮机构32，用于使装置可靠地自锁在期望的高度处。棘轮机构32包括爪板34，该爪板34与形成在装置10侧壁36上的齿34棘合(图1D)。棘轮机构32提供高度上的小增量，其容易地被使用者控制。横梁38(图1C)可以在侧壁36的内表面之间延伸，以加固结构并避免装置中央的塌陷，塌陷将导致棘轮的脱离。
现参考图1E和1F，其示出了使用另一个楔机构160的可扩张骨装置。楔机构160包括楔头162，楔头162在螺纹轴164的端上，螺纹轴164被螺纹地接纳在套管168的攻丝钻孔166内。楔头162被楔接在关节174的上枢转构件170和下枢转构件和172之间，上枢转构件170和下枢转构件和172分别枢转地连接到链接元件12。通过向枢转构件旋拧轴164，楔头162将枢转构件170和172彼此分离，这导致上支撑板14A和下支撑板14B在关节174处彼此之间距离更大。随着在关节174处的端比离开关节174的端的高，上支撑板14A和下支撑板14B因此倾斜。
现参考图2A和2B，其示出了根据本发明的另一实施例的用于扩张可扩张骨装置10的另一机构。在该实施例中，球囊40被放置在铰链18处，并且球囊40通过流体源42扩张(例如，加压的盐水或空气)。由于球囊40的扩张发生在铰链18处，所以棘轮机构32能够具有成角度的棘爪和棘齿，使得该扩张能够是非平行和／或非对称的，从而产生与前后面具有微小角度的扩张(如在L5-S1中)。如果需要，球囊40是能够被移除并且甚至被再插入的扩张装置的实例。
现参考图3，其示出了根据本发明的另一实施例的用于扩张可扩张骨装置10的另一机构。在该实施例中，千斤顶44被放置在铰链18处或在铰链18附近，并用于相对于下支撑板14B升高或降低上支撑板14A。千斤顶44可以是但不限于：机械千斤顶(例如，螺旋千斤顶、剪形千斤顶或其它)；或者液压或气压千斤顶；或者电动操作的千斤顶。
现参考图4A，其示出了根据本发明的实施例构造和操作的可扩张骨装置50。装置50具有铰链58，铰链58设有齿轮59，齿轮59可以棘轮咬合。装置50包括多个链接元件52，所述多个链接元件52中的每一个链接元件包括上支撑板54A和下支撑板54B，上支撑板54A和下支撑板54B可以通过楔机构或千斤顶或其它设备(未显示)扩张。链接元件52在设有齿轮59的铰链58处连接，齿轮59可以棘轮咬合。在装置中形成相对大的孔口56，例如但不限于，在装置的顶板和底板(上支撑板54A和下支撑板54B)，在装置的侧壁及近侧末端和远侧末端中。这样的大孔口能够具有额外的截面以形成壁的一部分。
上支撑板54A和下支撑板54B可形成有凹形切口57，以便在扩张时板沿切口57弯曲，从而提供非对称的弯曲或扩张。这能够设计以满足特别应用的需要。
现参考图4B，其示出了根据本发明的实施例构造和操作的可扩张骨装置60。装置60与装置50类似，同样的附图标记代表同样的元件。装置60与装置50不同的是，装置60具有形成在一个或更多个上支撑板54A和下支撑板54B中的弯曲沟槽62，而不是切口。沟槽62能够提供非对称的弯曲或扩张。
本发明提供了用于将扩张力或转动力传送到单独元件的力传递机构的不同实施例。
现参考图5A和5B，其示出了根据本发明的实施例构造和操作的力传递机构70。力传递机构70能够与同本发明的任何楔或千斤顶扩张机构结合使用。
力传递机构70包括经过链接元件71的扭转轴72。每个链接元件71具有上板71A和下板71B。邻近的扭转轴72由万向接头机构74(也被称为万向节)连接。扭转轴72被轴颈固定在轴承支座76中。图5C示出了在盘间隙中的链接元件71。
现参考图6A、6B和6C，其示出了根据本发明的另一实施例构造和操作的力传递机构80。力传递机构80能够与同本发明的任何楔或千斤顶扩张机构结合使用。
力传递机构80包括通过链接元件81的扭转轴82。每个链接元件81具有上板81A和下板81B。邻近的扭转轴82由啮合蜗轮机构84连接。这样的扭转轴能够是可移除的。
其它的力传递机构或元件包括但不限于：链条、线缆、柔性轴、弹簧，正时皮带、带和丝、激光切割管及其它。
本发明的范围包括之前描述的特征的组合和子组合两种，也包括所述特征的变型和变体，对于本领域普通技术人员而言，在阅读上面的描述之后所述变型和变体在会出现，并且所述变型和变体在不在现有技术中。

Claims (11)

1.一种可扩张骨装置，包括：
绕铰链彼此枢转地连接的多个链接元件，所述链接元件中的每个链接元件包括上支撑板和下支撑板；和
可操作地连接到所述链接元件的扩张机构，所述扩张机构使所述上支撑板相对于所述下支撑板移动靠近或远离所述下支撑板，并且其中所述上支撑板和所述下支撑板包括弯曲结构，从而所述上支撑板相对于所述下支撑板非平行和/或非对称地移动，并且其中所述扩张机构包括楔机构。
2.根据权利要求1所述的可扩张骨装置，其中在所述链接元件的所述上支撑板和所述下支撑板、侧壁以及近侧末端和远侧末端中形成孔口。
3.根据权利要求1所述的可扩张骨装置，进一步包括：
棘轮机构，所述棘轮机构包括爪板，所述爪板与形成于所述链接元件的侧壁上的齿棘合。
4.根据权利要求1-3中任一项所述的可扩张骨装置，其中所述链接元件的近端面和远端面是锥形的、倒角的或倒圆角的。
5.根据权利要求3所述的可扩张骨装置，其中横梁在所述链接元件的侧壁的内表面之间延伸。
6.根据权利要求1-3、5中任一项所述的可扩张骨装置，进一步包括力传递机构，所述力传递机构用于将扩张力或转动力传送到所述链接元件。
7.根据权利要求6所述的可扩张骨装置，其中所述力传递机构包括扭转轴，所述扭转轴穿过所述链接元件，并且所述扭转轴由万向接头机构连接。
8.根据权利要求6所述的可扩张骨装置，其中所述力传递机构包括扭转轴，所述扭转轴穿过所述链接元件，并且所述扭转轴由蜗轮机构连接。
9.根据权利要求1所述的可扩张骨装置，其中所述楔机构包括在螺纹轴的端部上的楔头，所述楔头被楔接在关节的上枢转构件和下枢转构件之间，所述关节连接所述链接元件。
10.根据权利要求1所述的可扩张骨装置，其中所述上支撑板也适于相对于所述下支撑板平行地移动。
11.根据权利要求1所述的可扩张骨装置，其中所述上支撑板和所述下支撑板中的至少一个支撑板包括附加附接结构，所述附加附接结构作为独立装置用于附接。
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