CN106714737A - 可阶梯式膨胀的椎骨间隙笼和用于其的植入仪器 - Google Patents

可阶梯式膨胀的椎骨间隙笼和用于其的植入仪器 Download PDF

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Publication number
CN106714737A
CN106714737A CN201480079831.0A CN201480079831A CN106714737A CN 106714737 A CN106714737 A CN 106714737A CN 201480079831 A CN201480079831 A CN 201480079831A CN 106714737 A CN106714737 A CN 106714737A
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implant
covering
implanting apparatus
vertebra
basic part
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CN201480079831.0A
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CN106714737B (zh
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K.德姆舍夫斯基
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Facet Link Inc
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Facet Link Inc
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    • A61F2002/4628Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
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    • A61F2/00Filters 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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    • A61F2/00Filters 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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    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/4688Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means
    • A61F2002/4696Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor having operating or control means optical

Abstract

用于联合两个相邻椎骨(9,9’)的椎骨间联合植入物,包括基础件(2)和覆盖件(3),其相应地构造用于贴靠到相邻椎骨(9,9’)的其中一个的面对的端板(92)处,其中,覆盖件(3)相对基础件(2)可调节高度,其中,在基础件(2)与覆盖件(3)之间设置有棘齿装置(4),其引起阶梯式的高度调节且相对回行确保所调整的高度。以此可实现取决于操纵次数的定义的膨胀。使得对膨胀状态的精确控制成为可能,也就是说以纯粹触觉的方式。另外提供了植入仪器,其实施成平行撑开件且具有作为撑开位移限制器或者共同起作用的力和位移测量装置的止挡。其可被如此更安全地植入,其中,带有其神经和韧带的脊柱的超载或受伤的风险被降低。

Description

可阶梯式膨胀的椎骨间隙笼和用于其的植入仪器
技术领域
本发明涉及一种带有用于贴靠在分别上部和下部的相邻椎体的端板处的底部件和覆盖件的可阶梯式膨胀的椎骨间隙笼以及一种用于其的植入仪器。
背景技术
由于劳损或病变在脊柱处产生椎间盘的退变。倘若带有适应症的保守治疗和/或物理治疗不起作用,时常表示要手术治疗。为此已知的是,将可移动或不可移动的植入物插入到带有退变的椎间盘的椎骨间隙中。该植入物承担退变的椎间盘的支承作用且就此而言又建立在相邻椎骨之间的可靠支撑。不可移动的植入物也被称为“笼”。
为了笼的植入已知不同的手术技术。传统的手术技术在于从腹部的进入,以便于如此避免在脊柱中的脊髓的损伤危险。然而,该优点以穿过患者腹腔或胸腔的极长的进入途径来换取。因为在此可能产生复杂性,所以建立了一种备选的即由背部的进入途径。该进入途径虽然提供了较短距离的优点,然而存在碰撞或损伤脊髓的危险。为了将该危险保持较小,通常以微创外科手术的途径实现该操作。此类由直接背部或者更多地由侧面的进入已知为PLIF手术技术(后腰椎骨间联合(posterior lumbar intervertebral fusion))或者TLIF(经椎间开口腰椎椎体间联合术(transforaminelle interkorporelle lumbareFusion)),在其中椎间盘被由后部或者旁边露出。由于在借助于微创手术的进入的情形中较小的横截面,在此笼的大小自然受到严重限制。
对于借助于PLIF或者TLIF技术的治疗而言已知非常小的笼。其所提供的优点是,即,其通过微创手术由于其小型性可被植入。然而,其小型性的固有缺点在于,支撑功能由于较小的尺寸被限制且时常是不充足的。笼的较大的实施方案虽然改善了支撑功能,然而这由于微创手术的限制是不切实际的。
发明内容
本发明目的在于将一种开头所提及的形式的笼改善成,使得在今后较小的、如其对于微创手术而言常见的那样的进入横截面的情形中然而可获得更好的支撑效果。
根据本发明的解决方案在于独立权利要求的特征。有利的改进方案是从属权利要求的对象。
在一种用于联合两个相邻椎骨的包括用于贴靠在上部和下部的相邻椎骨的端板处的基础件和覆盖件的椎骨间联合植入物的情形中,其中,覆盖件相对基础件可调节高度,根据本发明设置有在基础件与覆盖件之间的棘齿装置,其引起阶梯式的高度调节且相对回行确保所设置的高度。优选地,棘齿装置实施成,使基础件包括用于贴靠到下部椎骨处的底壁和由此上伸的竖壁,而覆盖件包括用于贴靠到上部椎骨处的盖壁和由此下伸的侧壁,其中,竖壁和侧壁是棘齿装置的部分。在此,棘齿装置适宜地具有多个在侧壁处的卡锁鼻部和在竖壁处的止动弹簧,或反之亦然。
本发明所基于的思想是,通过可调节高度的联合植入物将该植入物在紧凑状态中的植入的情形中通过微创入口被引入到椎骨间隙中,且其在该处在高度上膨胀。这通过操纵实施成棘齿装置的高度调节机构进行。以此可实现取决于操纵次数的定义的膨胀。对于外科医生而言因此使得关于膨胀状态的精确控制成为可能,也就是说以纯粹触觉的方式。因此本发明没有如其在膨胀状态的纯粹视觉的控制的情形中(必要时在伦琴控制的情形下)产生的那样的限制。
另外,利用该棘齿装置实现一次调整的膨胀状态的锁定。由于棘齿装置的形状配合,因此在非常高的负荷力的情形中也实现防止意外复位的保护。因此得出出色的稳定性,也就是说甚至紧接在手术之后,直至通过骨骼生长最后实现两个相邻椎体的完全联合。
有利地设置有双重棘齿装置,也就是说优选地在植入物的每个侧面处各有一个。这一方面在非中心出现的负荷的情形中也得出较可靠的支撑。另一方面,这样的双重棘齿装置使得调整两侧的不同高度成为可能,从而产生覆盖件相对基础件的定义的翻倾。因此可进行对在相应的椎骨间隙中在脊柱中的曲率的匹配。为此还可设置成,两个棘齿装置在高度上彼此偏移,也就是说优选通过其相应的卡锁鼻部的偏移。
优选地,两个竖壁在侧面地设置在底壁处,且底壁是有弹性的。这使得两个竖壁的灵活的可逆的撑开成为可能,从而使得膨胀运动被简化。同时,通过两个竖壁的精心规划的撑开可按期望实现用于覆盖件的复位可能性。这使得联合植入物的测试或者在过度膨胀的情形中的回置成为可能。在一备选的变体方案中,仅竖壁被有弹性地实施,而底壁是刚性的。因此避免底壁成拱形。
优选地,覆盖件由相比底部件缺乏弹性的材料制成。例如,覆盖件由钴铬合金构成,而基础件由更有弹性的钛合金构成。因此可实现更大的力承受能力,尤其在棘齿装置的卡锁鼻部处。
为了防止意外的过度膨胀,优选地设置有限制覆盖件的调节运动的捕获装置。适宜地,捕获装置由与凸肩突起部共同起作用的止动爪构成。因此以简单且有效的方式防止有害的过度膨胀。在一种备选的实施形式的情形中,捕获装置由在竖壁中的窗口和在侧面由侧壁伸出的接合到窗口中的横向销形成。优选地,横向销布置在侧壁处下部。因此,卡锁齿可在侧壁处不间断地经过,这改善了力传递。
为了使得精确调整成为可能,在双重棘齿装置的情形中卡锁鼻部在两个棘齿装置的其中一个处优选地实施成,使其具有为在两个棘齿装置的另一个处的卡锁鼻部的距离的整数倍的距离。例如,在其中一个棘齿装置处的距离如在另一个处的两倍那么大。因此,一方面可实现通过更大距离的快速调节。另一方面(且其在实际中是显著的优点)可在利用带有较小距离的棘齿装置的情形下实现更精确的调整,也就是说尤其鉴于在覆盖件与基础件之间的翻倾角度的调整。
用于卡锁鼻部彼此的距离的经验证的量是其抬高部(其通过在齿尖与齿根之间的距离来定义)的约1.5至3.0倍。
卡锁鼻部有利地非对称地、优选呈锯齿状地构造。这如此地允许如下设计,即在膨胀的情形中由于有利的侧边角度仅需较小的力,而相对复位施加较高的保持力。当支承侧边的角度处在5至35º的范围中、优选处在大约10º的情形中时,是已证实为可行的。支承侧边被理解为支撑负荷且因此反作用于复位。锯齿形状优选地设计成,得出在45º至70º的范围中、优选大约60º的啮合角。在一种特别适宜的实施形式中,卡锁鼻部彼此鳞片状地重叠,其中,配合侧边优选同一方向地、然而相比支承侧边更平但地定向。
该设计方案使得在膨胀的情形中的操纵力与相对复位的保持力之间的力比例的特别有利的调整成为可能。当止动弹簧形状配合地接合到卡锁鼻部中时,该有利的调整还可被提高,其中,卡锁鼻部的形状优选如此地被协调于止动弹簧,即实现自锁。因此得出相对非期望的复位的最大的保护,其最终仅还通过材料相对断裂或剪切的负荷极限来确定。
为了最大化自锁,在卡锁鼻部和止动弹簧处彼此共同起作用的面不平行地而是彼此呈锐角地指向。在此,呈锐角的被理解为相应的面在至卡锁齿的底部的方向上彼此分离。利用该设计方案实现如下,即,在负荷的情形下止动弹簧被进一步拉动到卡锁齿之间。因此,止动弹簧由卡锁齿的非期望的跳出被可靠地避免。如此使保护作用最大化。
优选地,在覆盖件与基础件之间形成内部空腔。这使得骨材料(例如移植物或碎片)的引入成为可能,以便于如此有助于增强骨材料的向内生长。为了骨材料的引入且尤其还地有助于从两个相邻椎骨向内生长,优选在盖板和/或底壁处设置有至少一个与空腔相连接的缺口。
另外可设置有闭锁元件,其可被推入到空腔中。因此在植入和膨胀到期望的高度上之后可将覆盖件固定在其位置中。如此得出额外的保护作用。优选地设置有多个带有不同高度的闭锁元件,从而视联合植入物的膨胀而定可推入匹配的闭锁元件。优选地在闭锁元件处设置有至少一个附加缺口,其与在盖板和/或底壁处的缺口对齐。因此,在被推入的闭锁元件的情形中还可促进骨材料到空腔中的向内生长。进一步优选地,覆盖件和/或基础件在其端侧处可具有开口。因此一方面进一步促进向内生长,而另一方面在植入之后骨材料仍还可通过该端侧的开口被引入到空腔中。
有利地,覆盖件和/或基础件在其端侧处被倒圆,尤其在其棱角处。这使得根据本发明的联合植入物到椎骨间隙中的推入更为容易。
优选地,覆盖件的顶侧和/或基础件的底侧结构化地实施。这理解成,其具有有规律的抬高部和凹槽。纵向(即在由端面至端面的方向上)延伸的细沟槽/或横向(即由侧壁至侧壁)延伸的凹陷是优选的。这些沟槽具有至少0.2mm至最高1mm的距离,而这些凹陷具有至少2mm且优选不大于5mm的宽度。细沟槽如齿部一样起作用且将椎骨间联合植入物保持在其位置处。凹陷保护椎骨间联合植入物免于尤其在力加载的情形下的移出,如其在患者弯腰或鞠躬的情形中经常发生的那样。此外,其初始地保护椎骨间联合植入物免于滑出。有利地,顶侧和/或底侧设有由促进骨材料的向内生长的钛等离子喷涂构成的涂层。钛等离子喷涂优选成带有最高90μm颗粒的细颗粒状,从而使得其还不封闭如上述沟槽这样的精细结构。优选地,在此靠近边缘的区域朝向端侧是光滑的或仅设有沟槽,而未设有凹陷。因此,确保了用于皮质的椎骨边缘的较大的承载能力。
椎骨间联合植入物的总设计方案优选通常是呈盒状的。这在生产技术上是有利的且简化了植入物到椎骨间隙中的直线引入。然而还可期望的是,植入物非直线地而是宁可呈弧形地实现。为此,椎骨间联合植入物优选呈圆弧状弯曲地构造。这简化了尤其在由斜后部进入的情形中借助于所谓的TLIF方法(经椎间开口腰椎椎体间联合术)的植入。此外,椎骨间联合植入物可以如下方式呈楔形,即使得一个端壁低于另一个。优选地,楔角在大约3º至15º的范围中。因此可实现对脊柱的曲率、尤其对脊柱前凸的更好的匹配、。
可适宜的是,将已膨胀的椎骨间联合植入物回置到如其被调整用于植入的那样的紧凑尺寸。这可在对有功效性的体外测试之后或紧接于必要时以测试的方式实现的(过度)膨胀来实现。为了可再次回置椎骨间联合植入物设置有一种用于棘齿装置的触发装置。其可在简单的情况中借助于布置在竖壁和/或侧壁的自由端部处的用于侧向地起作用的撑开元件的容纳部实现。该撑开元件撑开竖壁,从而使得卡锁齿从止动弹簧的接合区域移出,且覆盖件可又相对于基础件被回置。在一优选的实施形式的情形中,容纳部实施成在竖壁的上端部处的孔,优选在止动爪的区域中。这使得一种特别简单的复位选择成为可能,即使当仅在椎骨间隙之外的状态中时。
作为撑开元件特别适用呈钳状的仪器,其利用其夹钳抓住到容纳部中。
本发明进一步延伸到用于置入或者操纵椎骨间联合植入物的植入仪器。在此,植入仪器被优选设计成,使其具有最高与椎骨间联合植入物的横截面一样大的横截面。由此确保,膨胀可在利用植入仪器的情形下通过与椎骨间联合植入物的原本的置入相同的较小的微创的进入途径实现。额外的第二进入途径因此不是必需的。因此不仅得出成本降低而且维护患者。
植入仪器可实施成带有两个扩展块的调整楔扩张器。在此,调整楔优选布置在扩展块处的前部区域中。通过移动调整楔可引起扩展块的膨胀,其又由内部作用到覆盖件或者基础件上且这些因此膨胀。
优选地,对于调整楔的运动而言设置有牵引机构,其在扩展块之间被向后引导。此处,后部被理解为远离植入物向外至外科医生的方向上的导向。这对于外科医生而言使得由外部通过微创入口的舒适的操纵成为可能。牵引机构在扩展块之间的引导使得紧凑的结构成为可能。此外,这使得牵引机构免受机械损伤的良好的保护成为可能。牵引机构作为操纵芯轴的实施方案是有利的。其使得准确调节成为可能且此外允许通过在反方向上的扭转的可逆操纵。
在一种被证明有效的实施形式中,在操纵芯轴的前端部处布置有调整楔,且在后部的处在外面的端部处支承有调节轮。这使得由外部的舒适的可逆操纵成为可能。
原则上可足够的是,当通过外科医生的触觉反馈获得关于高度调节范围的表象。然而还可是有利的是,当植入仪器具有说明椎骨间联合植入物的所实现的高度调节的指示装置时。优选地,指示装置为此具有成比例于所实现的高度调节的图示。因此,对于外科医生而言使得已实现的膨胀的确定变得容易。
备选地,植入仪器还可设置成扭杆调节器。其包括导向件和可在其中摆动地引导的杠杆件,其中,在其处设置有两个用于基础件或覆盖件的容纳部。其适宜地设计成,基础件被保持在导向件的前端部处,而覆盖件被抗扭地保持在杠杆件处。为此适宜地在杠杆件的前端部处设置有螺旋连接,其接合到在覆盖件的端侧中的开口的相应的配合螺纹中。
杠杆件优选具有在其后端部处用于操纵的肘节。其支承在导向件中,该导向件为此构造成,使得杠杆件在径向上被可移动地支撑。这意味着,通过肘节在径向上的摆动使杠杆件相应地转动。
杠杆件优选具有另一轴向钻孔,固定芯轴被插入穿过该轴向钻孔。其用于覆盖件在杠杆件处的可容易解开的固定。被证明有效的是,在导向件处设置有带有用于肘节的凹口的钟状物。
在此凹口设计成,使其在径向上具有比相应于肘节厚度更大宽度。因此,肘节在径向上在钟状物中可移动且因此可被往复移动。该往复运动传递到被拧紧在前端部处的覆盖件上,其相应地翻倾且因此交替地在两个棘齿装置处使各一个卡锁齿进一步向上游动。以该方式引起高度调节。如果翻倾是期望的,此外可通过奇数次操纵过程调整翻倾。
另一备选的植入仪器实施成带有交叉杠杆的平行撑开件。交叉杠杆形成反向运动,由此撑开件在压向把柄的情形中撑开。该运动在作为不带有在其处须将把柄撑开的交叉杠杆的简单的钳的使用中更有利。此外,平行撑开件优选具有可调节的止挡装置。以其可确定之后不被超过的最高撑开。这尤其在带有困难的进入情况的植入的情形中是有利的,因为如此外科医生在撑开期间不再须手动控制所达到的位置。适宜地,转轮设有多个预定义的且做了记号的位置。因此,止挡装置被相应地调节。如此,期望的撑开程度可被容易地调整。
优选地,扩展块鉴于基础件或者覆盖件的保持不同地实施。优选地,仅在扩展块的其中一个处布置有用于形状配合的容纳的装置,也就是说优选地作为接合到在基础件中的缺口中的突起部。通过不同的设计方案,在如下意义中实现防止故障的编码,使得椎骨间联合植入物仅可以某一定向正确地被植入仪器容纳。由于错误地实现的容纳的故障因此被排除。
在另一实施形式中,植入仪器设有力测量装置,其与位移测量装置共同起作用成,使得其指示出在相应的操纵力的情形中所达到的撑开位移。因此建立操纵力与撑开位移之间的关系且指示给操作者。操作者可因此控制所施加的操纵力是否足以实现所期望的撑开。此外操作者可如此地测定哪些力对于确定的期望的撑开而言是必要的。如此以来,操作者获得脊柱的弹性或者刚性关于椎骨间隙通过撑开增大的量。其因此可当在确定的力的情形中面临太大的撑开时尽早识别出,且因此必要时避免神经和韧带的危险的损伤。同样地,其可辨认出,对于用于置入植入物的力求的撑开而言必要的操纵力有多大,且必要时当操纵力面临须达到太高的值时进行干预。带有其神经和韧带的脊柱的过载或者受伤因此以有效的方式被反作用。
适宜地,该仪器同样实施成平行撑开件,优选带有作为换向机构的交叉杠杆。因此可以简单的方式将操作者的(待)按压的手运动转换成扩展块的平行撑开的运动。
优选地实现经由作用到传递元件上的杠杆的实际操纵,该传递元件适宜地实施成力测量装置。因此可直接确定操纵力。通过使传递元件支撑在牵引机构的放置在后部(把柄方向)的端部处所确保的是,如此测得的力还恰是作用到牵引机构上且因此最后作用到扩展块上的力。
力测量装置的特别适宜的设计方案包括弹簧元件和指示用于弹簧行程的量的力刻度尺。因此以简单且稳健的方式实现在传统弹簧测力计的样式中的力测量。为了指示调节位移优选在牵引机构处设置有关联有位移刻度尺的标记。其如此示出以下两者,即所使用的操纵力和在此所达到的撑开行程。对于操作者而言,因此清晰地示出了对于撑开或者对于脊柱刚性的确定而言重要的力和位移的信息两者。
此外,本发明延伸到一种由椎骨间联合植入物和仪器构成的组件。
附图说明
接下来在参照附图的情况下根据有利的实施例详细阐述对本发明。其中:
图1:显示了用于在椎体处的经植入的状态中的椎骨间联合植入物的一实施例的视图;
图2:显示了根据图1中示出的实施形式的基础件和覆盖件的透视视图;
图3:显示了用于棘齿装置的作用的示意性图示;
图4:显示了根据图3的棘齿装置的齿的放大图示;
图5:显示了在实施例的一种变体方案的情形中的捕获装置的示例;
图6:显示了在锁定和解锁位置中的触发装置的图示;
图7:显示了在拆卸和装配状态中的保护元件的透视图示以及截面图示;
图8:显示了用于植入仪器的夹头的透视图示;
图9:显示了在放松的和部分膨胀的状态中的根据图8的植入仪器的截面图示;
图10:显示了以植入仪器的截面的俯视图以及细节图示;
图11:显示了第二实施形式的透视视图;
图12:显示了用于根据第三实施形式的椎骨间隙联合疗法的两件式的植入仪器;
图13:显示了在部分装配和完全装配的状态中的第二植入仪器的图示;
图14:显示了用于椎骨间联合植入物的另一实施例的透视图示;
图15:显示了相对图14的截面视图;
图16:显示了相对图14的细节放大;
图17:显示了相对图14的一种变体方案的侧视图;
图18:显示了朝向植入仪器的第四种实施形式的俯视图;
图19:显示了相对图18的细节放大;
图20:显示了相对图18的进一步的细节放大;
图21:显示了朝向植入仪器的第五实施形式的俯视图;
图22:显示了相对图21的部分截面形式的细节视图;且
图23:显示了相对图21的进一步的细节视图。
具体实施方式
在其整体上以附图标记1标明的椎骨间联合植入物设置用于在两个直接相邻的椎体9,9’之间的椎骨间隙91中的植入。在生理上完好无损的脊柱的情形中,在椎骨之间在椎骨间隙中存在椎间盘90。其由于疾病或劳损可退变,从而使得其至少部分须被切除。尽管椎间盘材料的损失为了实现椎骨间隙91的足够支撑且因此防止脊柱的虚脱,椎骨间联合植入物1被置入到椎骨间隙91中。其支撑地起作用且因此使得两个相邻椎骨9,9’在通过骨骼生长的自然途径上的联合变得容易。
椎骨间联合植入物1包括基础件2,其被放置在下部相邻的椎骨9的上端板92上。此外其包括贴靠在上部的相邻椎骨9’的下端板93处的覆盖件3。为了一方面确保基础件2在下端板92处且另一方面覆盖件3在上部椎骨9’的下端板93处的可靠贴靠,所必要的是,在其高度上相应地调整椎骨间联合植入物1。其须被膨胀到直至基础件2和覆盖件3牢固地贴靠在相应的端板92,93处的程度。
为了在膨胀的意义中使得基础件2与覆盖件3的彼此移开成为可能,设置有棘齿装置4。其包括多个在覆盖件处的卡锁齿43,其与在基础件2处的止动弹簧42共同起作用。
为了一方面将根据本发明的椎骨间联合植入物1保持紧凑且如此可通过在微创手术的途径中准备好的入口来植入,然而另一方面为了可取消在椎骨间隙91中的足够大的支撑作用,根据本发明的椎骨间联合植入物1高度可调地来实施。为此,其具有基础件2和在其高度上相对于基础件2可移动地布置的覆盖件3。基础件2大致呈穴状地实施且包括充当到下部的相邻椎骨9的端板92处的贴靠面的底壁22,以及在两个侧向面处各一个垂直向上伸的竖壁21。因此,基础件2在横截面上整体呈U形。在竖壁21的上端部处布置有作为棘齿装置4的一部分的止动弹簧42。此外,在竖壁21的上端部处大约在中间布置有突起部52,其形成捕获装置5的一部分。在底壁22中成型有多个开口24,其将在侧壁21之间的呈穴状的造型的内部中的空腔10与在底壁22之下的空间相连接。
这促进骨头到椎骨间联合植入物1中的向内生长。
另外,用于根据本发明的椎骨间联合植入物1的示出的实施例包括覆盖件3。其具有通常呈盒状的造型,带有大致平坦的充当用于上部的相邻椎骨9’的下端板93的贴靠面的顶侧33。在侧向面处向下伸出地布置有各一个侧壁31。其在其向外指向的面处支承有多个卡锁齿43,其形成棘齿装置4的一部分且与在基础件2处的止动弹簧42共同起作用。在该示出的实施例的情形中,在一端侧处设置有端壁30。其是可选的且同样可取消。另外,在侧壁31处大约在中间成型有贴靠肩53。其由其尺寸选择成,使其与在基础件2处的突起部52共同起作用。在此,贴靠肩53的布置选择成,使得其在覆盖件3相对于基础件2的最大的伸展位置中贴靠到突起部52处。因此实现止挡限制。突起部52和贴靠肩53因此作为捕获装置5共同起作用。在顶侧33处成型有多个缺口34,以便于使得骨材料到覆盖件内部中的向内生长成为可能。
为了植入,覆盖件3被置入到呈穴状的基础件2的空腔10中。因此,植入物在最小膨胀的状态中,如其在图3a中在最上面三个相叠布置的图示中绘出的那样。在该状态中,植入物被插入到椎骨间隙91中,直至其大约到达在图1b中示出的位置。其然后可在下一步骤中被膨胀到直至其被调整到椎骨间隙91的高度上的程度。这以如下方式进行,即通过覆盖件3借助于植入仪器8被向上移动,其中,止动弹簧42依次以不同的卡锁齿43逐次地接合在覆盖件3的侧向面31处且如此确保所达到的膨胀位置。膨胀的该过程在图3a中的三个图示中绘出。
卡锁齿43呈锯齿状地成形。每个齿43具有两个侧边45,47。在此,较短的侧边45是承载负荷的侧边,其力传递地与止动弹簧42到达接合。该承载负荷的侧边45向下指向地成形且进而在与其它未承载负荷的定位侧边47相同的方向上定向。由此在在以侧面观察的方式的情况中得出卡锁齿43的一定程度上呈鳞片状的重叠。在图4中示出的实施例中角度α和β选择成,使得角度α为大约60°而角度β为8°。止动弹簧42的顶侧46以上述角度β倾斜。因此与承载负荷的侧边45的向下指向的定向一起在负荷力F的作用下得出向内指向的侧向力L,其将止动弹簧42拉入到齿部43中且其以此防止从卡锁齿43的非期望的跳出。因此以如下方式实现自锁,即负荷力F越大,则固定力L变得越大。
为了防止在膨胀的情形中使覆盖件太远地向上移动且进而止动弹簧42从卡锁齿43的区域落出,备选地设置有一种如在图5中示出的那样的捕获装置5’。其包括在每个止动弹簧42处、更切确地说在其中间处的突起部52’。在覆盖件3处,在卡锁齿43之下布置有向下指向的弓形部53’,其尺寸选择成,使得其包围突起部52’。如果达到最大的膨胀,则弓形部53’接合到突起部52’之下且防止进一步的膨胀运动。
膨胀运动为了高度调节一般在棘齿装置4的两侧上均匀地实现,如也在图3a中画出的那样。然而还可期望的是,为了调整确定的翻倾角度非均匀地实现调节。按照是否在其中一侧上多次实现以一个或两个卡锁齿43的调节,期望的翻倾角度可被定义地调整。为此,外科医生仅需要计算“卡搭声”的次数,也就是说在棘齿装置4中通过将止动弹簧42接合到不同的卡锁齿43中的卡锁过程的次数。为了翻倾的更精确的调整,还可设置有更精确地阶梯化的齿43’,如此多的齿43’相比齿43以相应地一半的量来加倍。适宜地,两个棘齿装置中的仅一个设有更精细的齿,如在图5中示出的那样。可选地,齿43,43’的起点在两个棘齿装置之间彼此偏移。
如下可能是必要的,即,将覆盖件3从其经膨胀的位置中又回置到较少膨胀或完全不再膨胀的位置中,如其被用于植入的那样。为此适宜地设置有回置装置6。其包括带有呈钳状的夹钳61的仪器,其以相应的夹尖62在其正面处接合到在竖壁21的顶侧处的为了该目的所设置的容纳孔60中。通过夹钳61以呈钳状的运动的撑开,两个相对的竖壁21被彼此移开,由此止动弹簧42在相应的竖壁21处不再处在与在覆盖件3处的卡锁齿43的接合中。因此,棘齿装置41被释放。覆盖件3可自由地被向下移动且以该方式被回置。优选地,基础件2的材料为了该目的选择成,使得其可弹性地变形,尤其底壁22。这在图6中示出。
为了在完成膨胀之后获得用于所达到的高度调整的额外的确保,可设置有特殊的闭锁元件70。其优选如此地成形,即,其可被适配地推入到在覆盖件3与基础件2之间的在膨胀的情形中增大的空腔10中。显然,在此须视膨胀状态而定使用不同的闭锁元件70。闭锁元件70优选具有中央的缺口74,其与在覆盖件3处的缺口34或者在基础件2处的缺口24对齐。因此,空腔10可进一步容易达到且可接近用于骨材料的向内生长。闭锁元件70在经推入的状态中相对回到基础件2中的回行确保覆盖件3,如其在图7b中示出的那样。
为了借助于膨胀的高度调整设置有植入仪器。其实施成带有两个扩展块81的调整楔扩张器8。其在其前端部处设有容纳部84,其形状配合地接合到缺口34中。在前端部处,扩展块81被呈V形地切割,其中,在该切口中置入呈楔状成形的调整楔82。调整楔82与沿着植入仪器8的纵轴线在其整个长度上延伸(参见图10)的牵引机构80相连接。其以其在调整楔82处的前端部开始且在手轮88中的植入仪器8的后端部处结束,在该手轮中其经由芯轴螺纹89被支承。通过扭转手轮88,借助于芯轴螺纹89向后移动牵引机构80,由此调整楔82沉入到在两个扩展块81之间的呈V形的凹槽中。扩展块81由此被彼此驱散开(参见图9,用于未膨胀的起始状态的上部图示和用于膨胀状态的下部图示)。视芯轴螺纹89的斜度而定,外科医生可通过手轮88的确定次数的转动获得期望的撑开效果,由此覆盖件3关于基础件2高度适宜地被调节。为了所达到的膨胀状态的额外的控制设置有指示装置85。其包括布置在扩展块81处的刻度86以及布置在牵引机构80处的指示针87。指示针87与牵引机构一起在撑开过程的情形中被向后拉动,由此其相对于刻度尺86的位置可被改变且因此所达到的膨胀状态可被读取。
用于椎骨间联合植入物1’的第二个备选的实施例在图11中示出。其大致与根据图1的相同地构建,然而区别在于,其不呈盒状直线地而是大致呈圆弧状弯曲地实施。对于构造和工作原理相应地适用上述说明。
在另一尤其适合用于横向植入(如其在图1a中通过虚线在椎间盘90的区域中显示的那样)的实施形式的情形中,设置有椎骨间植入物的另一种实施形式。其在其端侧30的区域中具有一开口,在该开口中植入可拧入仪器的一部分(参见在图2a中虚线示出的开口38)。为此所设置的植入仪器7在图12和13中示出。操纵仪器包括杠杆件71以及导向件73。此外设置有螺纹杆72,其被置入到沿着杠杆件71的纵轴线布置的轴向钻孔75’中。杠杆件71在其后端部处具有相对于侧面径向突出的肘节75。在其前端部处,杠杆件71具有夹颚71’,其构造用于抓住基础件2的底壁22。导向件73在其前端部处具有第二夹颚73’,其以相应的方式构造用于抓住覆盖件3的盖壁33。在后端部处,导向件73具有导向钟状物77,其向前单侧敞开且在其后面封闭的端部处具有中央手柄78。在其前面的包围钟状物的敞开的端部的边缘处,其具有凹口79。凹口79如测量成,使得其在径向上看具有比杠杆件71的肘节75更大的宽度。
为了装配,螺纹杆72被插入穿过杠杆件71的轴向钻孔75’且以在其前端部处的螺纹72’固定到在覆盖件3的端侧30处的开口38的螺纹中。为了拧紧使用在螺纹杆72的后端部处的滚花头76。带有被固定在其处的覆盖件3的杠杆件71然后被放置到导向件73处,也就是说如此,即其以其肘节75接合到凹口79中。在其前端部处基础件2被插到操纵件73上。因此,植入物被插到在其装配位置中的仪器7上,也就是说不被膨胀。
膨胀以如下方式实现,即覆盖件3相对于基础件2逐渐地歪斜,从而总是在一侧上止动弹簧42进一步跳跃卡锁齿43。该相互的歪斜以如下方式实现,即肘节75在凹口79中由径向端部位置被往复摆动到另一径向端部位置中,在图13c中通过双箭头示出。由此,覆盖件3逐渐被翻倾且在此同时被膨胀。对于进一步的说明而言相应地适用上述说明。
用于椎骨间联合植入物的另一备选的实施形式在图14至17中示出。其基于在图2中示出的实施形式,且类似的部件设有相同的附图标记,从而就此而言取消阐述。该实施形式具有一种备选的捕获装置5’。其包括横向销52’,该横向销向外突出地布置在侧壁31处下部(也参见图16中的细节图示)。横向销52’接合到呈窗口状的在竖壁21中成型的切口53’中。通过其在垂直方向上拉伸的形状,其允许覆盖件2的高度调节,也就是说直至最后横向销52’抵靠到呈窗口状的切口53’的上端部处的程度。因此防止进一步的运动。横向销52’在侧壁31处下部的安装具有的优点是,在侧壁处的齿43可不间断地运转。其因此相比中断的在图5中示出的备选的实施方案更有刚性且更有力。
此外,在图14中示出的实施形式设有一种结构。其在其顶侧33处如也在其底侧22处那样具有凹陷29,其在横向上由一侧延伸至另一侧。其例如约2mm宽且用于将椎骨间联合植入物更好地锚固在椎骨9的端板92,93处。顶侧33和底侧22的之后在前部或者后部区域中达到平放的靠近边缘的区域保持无凹陷29,以便于不损伤在该区域中的承载能力。在纵向上构造有多个细沟槽28,其由一端侧延伸至另一个。其具有大约1mm的距离且同样用于更好的锚固。另外,顶侧33如同底侧22那样设有由钛等离子喷涂27构成的涂层。其是细颗粒状的且因此不阻塞沟槽28。该涂层促进骨材料的增长和向内生长。应注意,结构化或者涂层不仅限制于该实施形式,而且也能够在在其余实施形式中设置。
如由图17可辨认出的那样,椎骨间联合植入物可具有带有楔角γ的楔形。其因此更好地适合用于在这样的布置在脊柱的更强烈地弯曲的区段中的椎骨之间的植入。应注意,楔形不仅限制于该实施形式,而且也能够在其余实施形式的情形中设置。
用于植入仪器8’的另一实施形式在图18至20中示出。其以其前部的构造用于容纳椎骨间联合植入物的区域在很大程度上与在图10中示出的仪器一致。类似的部件携带有相同的附图标记,从而就此而言取消阐述。仪器8’实施成平行撑开件。其如钳子那样被操纵,其中,扩展块81’’,81’’’呈直线地被彼此移开。作为特殊性,仪器8’一方面具有交叉杠杆89’,以其形成反向运动。其以如下方式起作用,即,在压合在后部的把手区域中的仪器9’的情形中在前部区域中的扩展块81’’,81’’’彼此移开。这显著简化了手操作。此外,为了撑开设置有带有调整楔82的机构,如同也在图9和10中示出的仪器中那样。
另一方面,植入仪器8’具有止挡装置87’。其限制调整楔82’的调节距离且进而限制撑开行程。为此,在仪器8’的后端部处设置有转动轮88’,其可被调整到预先确定的位置中。视位置而定,其形成用于牵引机构80的或多或少远地前伸的经由拉出杠杆80’被操纵的止挡87’。外科医生在置入植入物之后为了撑开仅需要操纵拉出杠杆80’,更切确地说到如下程度,即直至牵引机构80以其后端部贴靠在可经由转动轮88’调整的止挡87处。因此,植入物以期望的方式被膨胀。在转动轮处布置有标记86’,其指示了相应可调整的膨胀位置。通过将手轮88’调整到期望的膨胀位置上来自动确保,植入仪器8’在达到该位置的情形中停止。过度膨胀的危险和由此所产生的对于患者的风险因此被排除。
上述植入仪器的一种变体方案在图21至23中示出。对于根据图18的仪器的类似部件携带有相同的附图标记,从而就此而言可取消阐述。仪器8’’具有壳体99,在其处布置有手柄和用于支承拉出杠杆80’的悬臂。此外设置有力测量装置94和位移测量装置95。力测量装置94包括外套96和圆筒弹簧98。圆筒弹簧98以其一端贴靠在外套96的后边缘96’处且以其另一端支撑在布置在牵引机构80的向后的端部处的盘80’’处。在外套上布置有刻度尺94’,其以壳体99的前端部作为参考指示经由拉出杠杆80’所施加的力。此外,在扩展块81’’的其中一个处设置有深度刻度尺85’,以便于确定扩展块的推入深度。
对于位移测量装置95而言构造有在壳体99的检视孔99’处的位移刻度尺97。其与在牵引机构80的周缘处的标记95’一起起作用且如此直接允许所达到的路程的读出。位移刻度尺97测量成,使得其不指示牵引机构80的行程,而是指示扩展块81’’,81’’’的膨胀路径。
因此,不仅过度膨胀的危险而且过量的力引入和由此产生的对于患者的风险被有效地克服。

Claims (15)

1.一种用于联合两个相邻椎骨(9,9’)的椎骨间联合植入物,包括基础件(2)和覆盖件(3),其相应地构造用于贴靠到所述相邻椎骨(9,9’)的其中一个所面对的端板(92)处,其中,所述覆盖件(3)相对所述基础件(2)能调节高度,其特征在于,在基础件(2)与覆盖件(3)之间设置有棘齿装置(4),其引起阶梯式的高度调节且相对回行确保所调整的高度。
2.根据权利要求1所述的椎骨间联合植入物,其特征在于,所述基础件(2)包括用于贴靠到所述相邻椎骨的其中一个(9)处的底壁(22)和由此上伸的竖壁(21),且所述覆盖件(3)包括用于贴靠到所述相邻椎骨的另一个(9’)处的盖壁(33)和由此下伸的侧壁(31),其中,所述竖壁(21)和所述侧壁(31)是所述棘齿装置(4)的部分,其中,优选地所述棘齿装置(4)是多件式的,且具有多个在其部分的一个(31)处的卡锁鼻部(43)和在其部分的另一个(21)处的止动弹簧(42),其中,优选地设置有两个棘齿装置(4),其中,所述卡锁鼻部(43)在所述两个棘齿装置(4)的其中一个处具有在所述两个棘齿装置(4)的另一个处的卡锁鼻部(43)的距离的整数倍的、优选两倍的距离。
3.根据权利要求1至2中任一项所述的椎骨间联合植入物,其特征在于,所述棘齿装置(4)的承载侧边(45)的角度β处在5至35º的范围中、优选大约10º,其中,进一步优选地所述卡锁鼻部(43)彼此鳞片状地重叠,其中,配合侧边(47)优选同向地、然而比所述承载侧边(43)更平整地定向。
4.根据前述权利要求中任一项所述的椎骨间联合植入物,其特征在于,设置有捕获装置(5),其限制所述覆盖件(3)的调节运动,其中,优选地所述捕获装置(5)由与凸肩突起部(53)共同起作用的止动爪(52)形成,和/或由在所述覆盖件(2)处的横向销形成,所述横向销接合到在所述基础件(3)处的呈窗状的切口中。
5.用于根据前述权利要求中任一项所述的能膨胀的椎骨间联合植入物的植入仪器,其特征在于,所述植入仪器(7,8)具有最高与所述椎骨间联合植入物(1)的一样大的横截面。
6.根据权利要求5所述的植入仪器,其特征在于,其实施成带有两个扩展块(81,81’)的调整楔扩张器(8),其中,调整楔(82)优选布置在所述扩展块(81,81’)的前部区域中,其中,优选设置有用于所述调整楔(82)的牵引机构(80)、尤其操纵芯轴(89),其在所述扩展块(81,81’)之间被向后引导。
7.根据权利要求5至6中任一项所述的植入仪器,其特征在于,所述植入仪器(8)具有指示装置(85),其优选成比例地说明所述椎骨间联合植入物(1)的所实现的高度调节。
8.根据权利要求5至7中任一项所述的植入仪器,其特征在于,其实施成平行撑开件、优选地带有作为反向运动的交叉杠杆(89’)。
9.根据权利要求8所述的植入仪器,其特征在于,所述牵引机构(80)由拉出杠杆(80’)操纵,对此优选设置有在预先确定的位置中能调整的止挡装置(87’)。
10.根据权利要求8或9所述的植入仪器,其特征在于,仅在所述扩展块的其中一个处设置有用于所述基础件和/或覆盖件(2,3)的形状配合的保持的装置,优选地作为仅接合到在所述基础件(2)中的缺口中的突起部(84)。
11.根据权利要求5至10中任一项所述的植入仪器,其特征在于,其设有力测量装置,其与位移测量装置共同作用成,使得其指示出在相应的操纵力的情况中所达到的撑开位移。
12.根据权利要求11所述的植入仪器,其特征在于,其实施成平行撑开件、优选带有作为反向运动的交叉杠杆。
13.根据权利要求11或12所述的植入仪器,其特征在于,其具有作用到支撑在所述牵引机构的后端部处的传递元件上的操纵杆,其中,所述传递元件优选包括所述力测量装置。
14.根据权利要求13所述的植入仪器,其特征在于,所述力测量装置实施成弹簧元件,且优选地力刻度尺布置在所述传递元件处且进一步优选地在所述牵引机构处布置有位移刻度尺。
15.一种由根据权利要求1至4中任一项所述的椎骨间联合植入物与根据权利要求5至14中任一项所述的植入仪器构成的组件。
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AU2014397165A1 (en) 2017-01-05
US20170112632A1 (en) 2017-04-27
EP3154478A1 (de) 2017-04-19
WO2015188887A1 (de) 2015-12-17
US10010429B2 (en) 2018-07-03
RU2017100330A (ru) 2018-07-10
RU2017100330A3 (zh) 2018-07-10

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