CN112603609B - 可扩张脊柱植入物系统 - Google Patents

可扩张脊柱植入物系统 Download PDF

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Publication number
CN112603609B
CN112603609B CN202011518021.4A CN202011518021A CN112603609B CN 112603609 B CN112603609 B CN 112603609B CN 202011518021 A CN202011518021 A CN 202011518021A CN 112603609 B CN112603609 B CN 112603609B
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China
Prior art keywords
implant
frame
distal
distal end
proximal
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CN202011518021.4A
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CN112603609A (zh
Inventor
A·J·库勒
A·J·麦尔肯特
K·E·米勒
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Warsaw Orthopedic Inc
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Warsaw Orthopedic Inc
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    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
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    • A61F2002/4625Special 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
    • A61F2002/4627Special 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 the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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    • A61F2220/0091Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

提供可扩张脊柱植入物,所述可扩张脊柱植入物具有框架,所述框架具有用于保留扩张插塞,使得在扩张之后骨生长促进材料可被引入到所述植入物的近端部分中的远端壁。公开各种植入物、系统和方法。

Description

可扩张脊柱植入物系统
本发明专利申请是是国际申请号为PCT/US2016/056869,国际申请日为2016年10月13日,进入中国国家阶段的申请号为201680060118.0,名称为“可扩张脊柱植入物系统和方法”的发明专利申请的分案申请。
技术领域
本公开大体上涉及用于治疗肌肉骨胳病症的医疗装置,并且更具体地说涉及一种包括用于植入可扩张脊柱植入物的可扩张脊柱植入物系统的手术系统和用于治疗脊柱的方法。
背景技术
脊柱病症(如椎间盘退行性疾病、椎间盘突出、骨质疏松、脊椎前移、狭窄症、脊柱侧凸和其它弯曲异常、脊柱后凸、肿瘤和骨折)可由包括以下的因素引起:受伤和衰老所导致的外伤、疾病和退行性病况。脊柱病症通常导致包括以下的症状:疼痛、神经损伤以及部分或完全丧失活动性。
如药物治疗、康复和锻炼等非手术治疗可能有效,但可能无法减轻与这些病症相关联的症状。这些脊柱病症的手术治疗包含融合、固定、矫正、椎间盘切除术、椎板切除术和可植入假体。作为这些手术治疗的一部分,脊柱构建物(例如骨骼紧固件、脊柱杆和椎体间装置)可用来为治疗区域提供稳定性。举例来说,在手术治疗期间,椎体间装置可被引入到邻近椎骨体之间的间隙(椎体间间隙)以恰当地隔开椎骨体并且为骨生长促进材料提供容座。
近年来,已经引入提供超出椎骨体的静态间隔的额外能力的椎体间装置。举例来说,一些装置具有扩张能力,使得植入物可在收缩状态下被引入到椎体间间隙,并且然后扩张以产生额外间隔并且,在一些情况下,通过仅在植入物的一个端部或部分上选择性地扩张来引入或恢复脊柱的弯曲。然而,许多现有可扩张椎体间设计利用可在植入物扩张之后阻止外科医生将骨生长促进材料引入到椎体间植入物中的内部机构。本公开试图解决在现有技术中的此缺点和其它缺点。
发明内容
在一个实施例中,提供可扩张脊柱植入物。植入物包括包含近端壁和远端壁的框架,其中近端壁限定近端孔洞,并且远端壁限定远端孔洞。植入物还包括可移动地安置在框架的远端孔洞中的插塞和与框架可操作地接合并且被配置成当插塞相对于框架在远端方向上移动时从框架向外扩张的端板。
在一个替代实施例中,提供包括可扩张脊柱植入物和插入仪器的系统。插入仪器包含套管式外轴以及可去除且可旋转地安置在套管式外轴内的驱动器轴。可扩张脊柱植入物包含具有近端壁和远端壁的框架,其中近端壁限定近端孔洞,并且远端壁限定远端孔洞。框架的近端壁被配置成接收套管式外轴的远端端部以便于操控可扩张脊柱植入物。可扩张脊柱植入物还包含安置在框架的远端孔洞中的可移动插塞,其中插塞包含接口,所述接口被配置成通过驱动器轴的远端端部可操作地接合以相对于框架移动插塞。可扩张脊柱植入物还包含与框架接合并且被配置成当插塞通过插入仪器的驱动器轴移动时相对于框架移动的端板。驱动器轴还被配置成可从插入仪器的套管式外轴去除,使得在插塞已经相对于框架向远端移动之后,骨生长促进材料可通过插入仪器的套管式外轴引入到框架中。在一些实施例中,公开各种其它植入物、系统和方法。
附图说明
本公开进一步通过伴随以下附图的具体说明告知,在附图中:
图1为根据本公开的原理的处于闭合配置的可扩张脊柱植入物系统的一个实施例的透视图;
图2为根据本公开的原理的处于打开配置的可扩张脊柱植入物系统的透视图一个实施例;
图3为根据本公开的原理的在图1中示出的组件的透视图,但是其中一个端板被去除以示出闭合的可扩张脊柱植入物系统的内部结构;
图3A为根据本公开的原理的端板组件的透视图;
图4为根据本公开的原理的在图1中示出的组件的透视图,但是其中一个端板被去除以示出打开的可扩张脊柱植入物系统的内部结构;
图5为根据本公开的原理的处于闭合配置的可扩张脊柱植入物系统的一个实施例的透视图;
图6为根据本公开的原理的处于打开配置的可扩张脊柱植入物系统的一个实施例的透视图;
图7为根据本公开的原理的在图5中示出的组件的透视图,但是其中一个端板被去除以示出闭合的可扩张脊柱植入物系统的内部结构;
图8为根据本公开的原理的在图6中示出的组件的透视图,但是其中一个端板被去除以示出打开的可扩张脊柱植入物系统的内部结构;
图9为根据本公开的原理的包括与可扩张脊柱植入物接合的插入仪器的可扩张脊柱植入物系统的组件的透视图;
图10为图9中示出的组件的透视图,还示出驱动器轴延伸通过套管并且与插塞接合;
图11为在图9中示出的组件的透视图,还示出驱动器轴延伸通过套管并且与插塞接合以使端板相对于框架扩张;
图12为在图9中示出的组件的透视图,还示出驱动器轴被从套管去除;
图13为根据本公开的原理如用于PLIF手术程序中的可扩张脊柱植入物系统的一个实施例的俯视图;
图14为根据本公开的原理的如用于PLIF手术程序中的在图13中示出的组件的透视图;
图15为根据本公开的原理的如用于TLIF手术程序中的可扩张脊柱植入物系统的一个实施例的俯视图;
图16为根据本公开的原理的如用于TLIF手术程序中的在图15中示出的组件的透视图;
图17为根据本公开的原理的如用于TLIF手术程序中的在图15中示出的组件的透视图;和
图18为具有单个可移动端板并且其中框架可基本上与至少一个端板成一体的可扩张脊柱植入物系统的一个实施例的透视图。
具体实施方式
所公开的手术系统和相关使用方法的例示性实施例就用于肌肉骨胳病症的治疗的医疗装置方面,并且更具体地说就可包括可扩张脊柱植入物、插入仪器的可扩张手术植入物系统和/或用于治疗脊柱的方法进行论述。
在一些实施例中,本发明系统包括适合于成对或单个从正背侧插入(有时被称为PLIF程序)并且然后可在远端端部处扩张以便赋予和/或加强脊柱的脊柱前凸弯曲的可扩张脊柱植入物系统。在本文所示出的一些实施例中,可扩张脊柱植入物系统还可被配置成用于倾斜后侧程序和/或椎间孔腰椎椎体间融合(有时被称为TLIF程序)。另外,在各种实施例中所公开的框架可被配置成将脊柱植入物的可移动插塞放置在脊柱植入物内的大致远端位置,以便在已使用本文所描述的各种技术插入和/或扩张植入物之后清除在植入物内的近端体积用于填充骨生长促进材料。框架和其它各种脊柱植入物组件还可被配置成具有一个或多个侧壁和/或开口,以在插入和/或部署脊柱植入物之后将骨生长促进材料引导到椎间或椎体间间隙的选定区域。在一些实施例中,脊柱植入物系统还可具备渐缩远端尖端(如从上方或顶表面观察),使得植入物被成型用于从倾斜路径插入并且以跨椎间或椎体间间隙的对角线放置。
在一些实施例中,脊柱植入物系统还可用来通过在脊柱植入物植入并扩张的情况下以选定等级增大和/或恢复椎骨体之间的适当脊柱前凸角来恢复和/或赋予患者矢状平衡。在一些实施例中,可根据双侧PLIF途径采用一对这类脊柱植入物并使其扩张到不同高度以赋予和/或恢复脊柱前凸角以及使脊柱在冠状面中对齐(以便治疗例如脊柱侧凸弯曲)。在一些实施例中,可根据后侧TLIF途径采用单个这类脊柱植入物并使其扩张到不同高度以赋予和/或恢复脊柱前凸角以及使脊柱在冠状面中对齐(以便治疗例如脊柱侧凸弯曲)。在所描述的各种实施例中,脊柱植入物系统可用于治疗超出一级融合的脊柱病况的多种复杂脊柱程序。此外,在所附实施例中所描述的脊柱植入物系统还可用作具有一定可扩张高度的融合装置,用于使植入物适应特定椎体间椎间盘间隙,从而恢复邻近椎骨体之间的间隔并且促进邻近椎骨体之间的脊柱融合。
在一些实施例中,并且如上文所提及,本公开可用来治疗脊柱病症,例如椎间盘退行性疾病、椎间盘突出、骨质疏松、脊椎前移、狭窄症、脊柱侧凸和其它弯曲异常、脊柱后凸、肿瘤和骨折。在一些实施例中,本公开可用于其它骨和骨骼相关的应用,包括与诊断和疗法相关联的那些应用。在一些实施例中,所公开的脊柱植入物系统可替换地可用于对处于俯卧或仰卧位置的患者进行手术治疗,和/或对脊柱和在其它身体区域中采用各种手术途径,包括前部、背侧、背侧中线、正侧面、后侧倾斜和/或前侧倾斜途径。本公开可替代地还可用于治疗脊柱的腰椎、颈、胸、骶骨和骨盆区的程序。本公开的脊柱植入物系统还可用于动物、骨骼模型和其它非生命基物,例如用于培训、检验和演示。
通过参考结合形成本公开的一部分的附图图式进行的实施例的以下详细描述可更容易地理解本公开。应理解,本申请不限于本文描述和/或示出的具体装置、方法、条件或参数,并且本文中所使用的术语出于仅借助于实例描述特定实施例的目的而不旨在进行限制。在一些实施例中,除非上下文另外明确规定,否则如说明书中所使用且包括所附权利要求书,单数形式“一(a、an)”和“所述(the)”包括复数,并且参考特定值包括至少所述特定值。本文中范围可表述为“约”或“大致”一个特定值和/或到“约”或“大致”另一特定值。当表述这类范围时,另一个实施例包括从所述一个特定值和/或到所述另一个特定值。类似地,当使用前置词“约”将值表述为近似值时,应理解,所述特定值形成另一个实施例。还应理解,所有空间参考,例如水平、垂直、顶部、上部、下部、底部、左侧及右侧,只是出于说明目的,并且可在本公开的范围内变化。举例来说,参考“上部”和“下部”是相对的,并且仅用于相对于另一个的上下文中,且不必为“上方”和“下方”。
如说明书中所使用且包括所附权利要求书,疾病或病况的“治疗(treating)”或“治疗(treatment)”是指进行以下程序,所述程序可包括:向患者(正常人或其它人或者其它哺乳动物)施用一种或多种药物、生物制剂、移植骨(包括例如同种移植、自体移植、异种移植)或骨生长促进材料;采用可植入装置和/或采用治疗疾病的仪器,例如用于去除椎间盘凸出或突出部分和/或骨刺部分从而致力于缓解疾病或病况的病征或症状的微椎间盘切除仪器。缓解可能发生在疾病或病症的病征或症状出现之前以及出现之后。因此,治疗包括预防疾病或不希望的病况(例如,预防疾病发生于可能易患所述疾病但尚未被诊断已患上所述疾病的患者身上)。另外,治疗不需要完全缓解病征或症状,不需要治愈,并且具体地包括对患者仅有边际效应的程序。治疗可包括抑制疾病,例如遏制其发展,或缓解疾病,例如引起病退。举例来说,治疗可包括减轻急性或慢性炎症;缓解疼痛及减少和诱导新韧带、骨骼和其它组织的再生长;作为手术的辅助;和/或任何修复程序。并且,除非另外明确提及,否则如说明书中所使用且包括所附权利要求书,术语“组织”包括软组织、韧带、肌腱、软骨和/或骨骼。如本文中所使用的术语“骨生长促进材料”可包括但不限于:呈多种形式的移植骨(自体移植、同种移植、异种移植)和组合物(包含但不限于颗粒移植骨);骨诱导材料,如骨形态生成蛋白(BMP)(包括但不限于可购自美敦力公共有限公司(Medtronic plc)的)和替代的小分子骨诱导物质;骨传导性材料,如呈多种形式的脱矿骨基质(DBM)和组合物(袋装油灰、切片(包括但不限于可购自美敦力公共有限公司的/>产品系列));胶原海绵;骨油灰;基于陶瓷的空腔填料;陶瓷粉末;和/或适合于诱发、传导或促进现有骨结构的骨生长和/或骨融合的其它物质。这类骨生长促进材料(在本文的一些附图中表示为“BG”)可以多种固体、油灰、液体、胶体、溶液或适合于装填或放置到本文所描述的实施例的各种植入物10、20中或各种植入物10、20周围的其它制剂提供。
以下论述包括对根据本公开的原理的包括一个或多个脊柱植入物的手术系统、相关组件和采用所述手术系统的方法的描述。公开各种替代实施例并且每个实施例的单独组件可与其它实施例一起使用。详细参考本公开的例示性实施例,所述实施例在附图中说明。转向图1-12,说明手术系统(例如可扩张脊柱植入物10、20)和包括插入仪器30的相关联系统的组件。
可扩张脊柱植入物系统10、20、30的组件可由适合于医学应用的生物上可接受的材料制成,包括金属、合成聚合物、陶瓷和骨材料和/或其复合材料。举例来说,可扩张脊柱植入物系统(包括但不限于植入物10、植入物20、插入仪器30)的组件单独地或共同地可由以下材料制成:如不锈钢合金、市售纯钛、钛合金、等级5的钛、超弹钛合金、钴-铬合金、不锈钢合金、超弹金属合金(例如镍钛诺、超弹塑料金属,如GUM)、陶瓷和其复合材料如磷酸钙(例如SKELITETM)、热塑性塑料,如聚芳基醚酮(PAEK),包括聚醚醚酮(PEEK)、聚醚酮酮(PEKK)和聚醚酮(PEK)、碳-PEEK复合材料、PEEK-BaSO4聚合橡胶、聚对苯二甲酸亚乙酯(PET)、织物、硅氧烷、聚氨基甲酸酯、硅氧烷-聚氨基甲酸酯共聚物、聚合橡胶、聚烯烃橡胶、水凝胶、半硬质和硬质材料、弹性体、橡胶、热塑性弹性体、热固性弹性体、弹性复合材料、硬质聚合物,包括聚苯、聚酰胺、聚酰亚胺、聚醚酰亚胺、聚乙烯、环氧树脂、骨材料,包括自体移植、同种移植、异种移植或转殖基因皮层和/或皮质网状骨,和组织生长或分化因子、部分再吸收材料,例如金属和钙基陶瓷的复合材料、PEEK和钙基陶瓷的复合材料、PEEK与再吸收聚合物的复合材料、全部再吸收材料,例如钙基陶瓷,如磷酸钙、磷酸三钙(TCP)、羟基磷灰石(HA)-TCP、硫酸钙,或其它再吸收聚合物,如聚酰胺、聚乙交酯、聚酪氨酸碳酸酯、聚己内酯和其组合。
脊柱植入物系统10的各种组件可由包括以上材料的材料复合材料形成或构造而成,以实现各种所希望的特性,如强度、硬度、弹性、顺应性、生物机械学性能、耐久性和射线可透性或成像偏好。可扩张脊柱植入物系统10、20、30的组件单独地或共同地还可由如上述材料中的两种或更多种的组合的异构材料制成。可扩张脊柱植入物系统10、20、30的组件可单块形成、一体地连接或包括紧固元件和/或仪器,如本文所描述。举例来说,在一些实施例中,可扩张脊柱植入物系统10、20、30可包含可扩张脊柱植入物10、20,所述可扩张脊柱植入物10、20包含PEEK和/或钛结构,其中射线可透过标记(如钽销和/或长钉)选择性地放置在植入物中,从而当可扩张脊柱植入物10、20放置在脊柱中时为外科医生提供放置和/或尺寸信息。可扩张脊柱植入物系统10、20、30的组件可使用多种减材和增材制造技术形成,包括但不限于机械加工、碾磨、挤出、成型、3D打印、熔结、涂布、气相沉积和激光/电子束熔融。此外,可扩张脊柱植入物系统10、20、30的各种组件可用多种添加剂或涂层涂布或处理以提高生物相容性、骨生长促进或其它特征。举例来说,端板140、150、240、250可选择性地涂布有骨生长促进或骨向上生长促进表面处理物,可包括但不限于钛涂层(固态、多孔或纹理化)、羟基磷灰石涂层或钛板(固态、多孔或纹理化)。
可扩张脊柱植入物系统10、20、30可用于例如微创程序(包括经皮技术、迷你开放和开放手术技术)以在患者身体内的手术部位处(例如,脊柱的区段)递送并引入器械和/或一个或多个脊柱植入物。在一些实施例中,可扩张脊柱植入物系统10、20、30可用于手术程序,如本文所描述,和/或例如椎体切除术、椎间盘切除术、融合和/或采用脊柱植入物恢复椎骨的机械支撑功能的固定治疗。在一些实施例中,可扩张脊柱植入物系统10、20、30可用于手术途径,包括但不限于:背侧腰椎椎体间融合(PLIF)、倾斜腰椎椎体间融合、椎间孔腰椎椎体间融合(TLIF)、各种类型的前部融合程序和脊柱的任何部分(例如,骶骨、腰椎、胸和颈)中的任何融合程序。可扩张脊柱植入物系统10、20、30在PLIF和TLIF技术中的例示性使用大体上在图13-17中示出。
如大体上在图1-8中示出,示出可扩张脊柱植入物10、20的两个例示性实施例(在例示性图1-4中突出植入物10,而在例示性图5-8中突出植入物20)。参考图1-2,可扩张脊柱植入物10可包含框架100,所述框架100包含近端壁110和远端壁120。框架100可提供用于将扩张机构放置在植入物10远端的机构,使得在植入物10扩张时提供更靠近植入物的近端端部的充分空间(例如,如至少部分在框架100内),以便于骨生长促进材料的后装填。举例来说,框架100的近端壁110可限定近端孔洞111,所述近端孔洞111可适合于接收插入仪器30的至少一部分,骨生长促进材料可通过所述近端孔洞111引入到植入物10的近端部分中。此外,框架的远端壁120可限定适于接收插塞130的远端孔洞121(例如参见图2)。如本文进一步描述,插塞130可移动地安置在框架的远端孔洞121中。
可扩张脊柱植入物10可进一步包含第一端板140,所述第一端板140与框架100可操作地接合并且被配置成当插塞130在远端方向D(参见图3-4)上移动时从框架100向外扩张。此外,在一些实施例中,可扩张脊柱植入物10可包含相对的第一和第二端板140、150,如大体上在图1-2中示出。在可扩张脊柱植入物10的一些这类实施例中,第二端板150可与框架100可操作地接合并且被配置成当插塞130在远端方向D上移动时从框架100向外扩张。此外,如在图1中示出,第二端板150可绕框架100并且与第一端板140相对安置,其中第一端板140和第二端板150从植入物10的近端端部延伸到植入物10的远端端部(沿植入物10的长度L)并且至少部分包围框架100。类似结构还在图5-8的植入物20中示出,其中端板240、250协作以至少部分包围框架200(例如参见图5)。各种端板140、150、240、250在多个平面中可具备凸表面以符合邻近椎骨体端板(参见如在图14和16中示出的V1、V2)。应理解,各种端板140、150、240、250的表面还可由仅一个平面上的凸面构造成或不含任何凸面。此外,接触端板140、150、240、250的表面的椎骨体V1、V2可具备各种防迁移和/或骨融合特征,包括但不限于:脊、齿、孔和涂层(包括但不限于多孔钛涂层,如在可购自美敦力公共有限公司的卡帕斯通(Capstone)PTCTM插入物上提供的那些)。
图18示出仅包含第一端板140的可扩张脊柱植入物10的实施例,所述第一端板140与框架100可操作地接合并且被配置成当插塞130在远端方向D(参见图3-4)上移动时从框架100向外扩张。在图18的实施例中,第二端板150可与框架100一体地形成和/或相对于框架100不可移动,使得当插塞130向远端移动时,仅第一端板140(经由销154铰接到框架100)。在这类实施例中,远端头部分135可被修改以接合可移动第一端板140和静态第二端板150。举例来说,如大体上在图3A中示出,可移动第一或第二端板150(和/或互补端板140)可包含斜坡表面153,在植入物10扩张时,在所述斜坡表面153上可承载远端头部分135的斜坡表面136。斜坡136/153机构可与成对侧向杆137和轨道145系统(参见图18)协作以优化植入物10的打开和/或扩张。
大体上参考图1-4,端板140、150可经由靠近或位于框架100的近端壁110上的铰链机构与框架100可操作地接合。举例来说,可提供接合限定在框架100中的对应销孔洞112的销154,使得端板与框架100可操作地接合和/或相对于框架100铰接,使得在插塞130相对于植入物10的框架100向远端D移动时,端板140、150可借助销154和销孔洞112的协作可相对于框架100扩张。类似铰链机构还相对于图7-8的实施例示出,所述铰链机构包含与销孔洞212接合以将框架200与端板240、250连接成处于铰接关系的销154。虽然多零件机械铰链在所描绘的实施例中的一些中示出,但是应理解,其它类型的铰链和/或连接机构也可用于将框架100与植入物的可扩张端板140、150可操作地接合。举例来说,在一些实施例中,可利用“活动铰链”,其中端板140、150至少部分在铰接点处与框架100一体地形成,但是具有允许端板140、150绕铰链连接件旋转的切口或挠曲点。综上所述,框架100和端板140、150可以多种不同的方式可操作地接合,包括但不限于:一体式连接、可分离连接、使用紧固件或粘合剂的机械固定连接、可释放连接(包括但不限于键槽和部分打开的铰链)和其它连接类型。在一些实施例中,框架100和端板140、150可使用增材制造技术一体地形成,如3D打印或熔结激光/电子束熔融、铸造、挤出或使用从一种或多种库存材料减材的制造技术以一体式形式进行的机加工。
在一些实施例中,可扩张脊柱植入物10的框架100进一步包含与近端壁110和远端壁120接合的至少一个侧壁102。如大体上在图3中示出,侧壁102或侧壁102、104可被配置成使近端壁110和远端壁120沿可扩张脊柱植入物10的纵向轴线(基本上平行于和/或几乎平行于长度L延伸)隔开。侧壁102、104还可被配置成在植入物10的近端部分中容纳骨生长促进材料,所述骨生长促进材料可经由近端孔洞111预装填或后装填到植入物10中。侧壁102、104可与近端壁110和远端壁120协作以产生四边框架100(其可限定侧孔洞,如在图3-4中示出)。在一些这类实施例中,框架可限定内部螺纹103,所述内部螺纹103被配置成当插塞130相对于框架100的远端壁120大体上定位在近端时与插塞130的外部带螺纹表面131协作。
框架100可尤其适用于以下一些实施例中:将插塞130相对于植入物10的总长度L放置在大致远端位置,使得植入物的远端部分(例如在基本上由框架100涵盖的体积内)可打开并且自由填充(或在已经将植入物放置在椎骨体之间的椎间盘间隙中(例如参见将植入物10放置在椎骨体V1与V2之间,在图14和16中示出)之后“后装填”有骨生长促进材料)。如本文关于图1、3、5和7所描述,植入物10、20可包含或限定沿其纵向轴线从其近端端部110延伸到其远端端部144的长度L。在一些这类实施例中,框架的远端壁120可安置在长度L的至少三分之一(1/3)(即在从近端端部110向远端隔开距离W的位置处,如大体上在图3和7中示出)。在其它实施例中,框架的远端壁120可安置在长度L的其它分数处(即在从近端端部110向远端隔开距离W的位置处,如大体上在图3和7中示出),包括但不限于至少1/10、1/8、1/5、1/4、2/5、3/4、7/8和9/10。在其它实施例中,框架的远端壁120可安置在从近端端部110向远端隔开距离W的位置处,如大体上在图3和7中示出,其中距离W在距离L的0到100%范围内,但是在一些情况下,距离W为距离L的至少0.25,以提供在植入物10的近端部分中的间隙用于当插塞130向远端移动时骨生长促进材料充分地后装填到至少部分由距离W限定的区域中。因此,植入物10的近端部分(如至少部分由框架100限定的内部体积)可基本上保持打开并且与框架100的近端孔洞111流体连通,使得在插塞130在远端方向D上移动之后(参见图3示出插塞处于初始位置,并且图4示出插塞向远端移动以展现框架100体积保持打开并且与近端孔洞111流体连通)可通过框架100的近端孔洞111放置骨生长促进材料。
在其它实施例中,如相对于图5-8中的植入物20示出,单个侧壁204可替换图1-4的双壁实施例以使框架100的远端壁120与框架的近端壁110隔开。在具有单个侧壁204的一些这类实施例中,框架200可基本上在植入物10的一侧上打开以允许经由框架200的打开侧后插入装填骨生长促进材料。框架200的“打开”或壁-少侧(其可大体上与侧壁204相对定位)也可用于引导和/或容纳可通过植入物20的框架200的近端孔洞211引入到植入物植入部位的骨生长促进材料。至于具有两个侧壁102、104的“闭合”实施例,单个侧壁204实施例也可限定内部螺纹203,所述内部螺纹203被配置成当插塞230相对于框架200的远端壁220大体上定位在近端时与插塞230的外部带螺纹表面231协作。
在各种实施例中,在可扩张脊柱植入物10、20中提供的插塞130、230可包含带螺纹外表面131(例如参见图1),并且远端孔洞121可包含与插塞130的带螺纹外表面131可操作地接合的互补带螺纹内表面。插塞的带螺纹外表面131可安置在插塞130的近端端部上,使得当插塞130相对于框架100的远端壁120旋转时,插塞130向远端D移动,如在图4中示出。在一些实施例中,如大体上在图4和8中示出,框架100可包含连接远端壁120和近端壁110的侧壁104,其中在侧壁104处包含侧壁带螺纹表面103,所述侧壁带螺纹表面103被配置成与插塞130的带螺纹外表面131可操作地接合(尤其当插塞仍相对于框架100定位在近端时)。侧壁带螺纹表面203的替代实施例也在图8中示出。此外,插塞130还可包含远端头部分135,所述远端头部分135被配置成在插塞130在远端方向D上移动的情况下,促使端板140远离框架100。远端头部分135在一些实施例中(如大体上在图1-4中示出)可配置有独立结构,所述独立结构具有可被配置成与端板140、150上的互补斜坡表面对接的斜坡表面136。举例来说,如在图3A中示出,端板150(和互补端板140)可包含斜坡表面153,在植入物10扩张时所述斜坡表面153上可承载远端头部分135的斜坡表面136。斜坡136/153机构可与侧向杆137和轨道155系统协作以便优化植入物10的打开和/或扩张。举例来说,斜坡136/153机构可提供前向扩张机构,在插塞130移动时,所述前向扩张机构随后由侧向杆137和轨道155系统辅助以扩张植入物。此外,侧向杆137和轨道155系统还可通过沿着由斜坡136/153机构提供的相对平滑的斜坡斜面朝向框架100向内拉动端板140、150而使植入物10的扩张是可逆的。此外,插塞130可包含独立连接元件132、133,使得插塞的远端头部分135可相对于框架100向远端移动而不旋转,而插塞130的近端部分(如限定带螺纹外表面131的所述部分)能够在框架100的远端壁120的远端孔洞121中自由旋转。
在其它实施例中,如大体上在图5-8中示出,插塞230可包括包含锥形圆柱体的远端头部分235。在一些这类实施例中,远端头部分235可被配置成在近端部分(例如限定外部带螺纹表面231)相对于框架100旋转以在远端方向D上驱动插塞230时与插塞230一起旋转和/或仅相对于框架100向远端D移动。根据一些这类实施例,远端头部分235可被配置成与限定在端板240、250的内表面上的轮廓承载表面253(在一些情况下包含斜坡和/或截头圆锥形凹表面)协作。
远端头端部分135、235可以不同方式配置以提供导入或逐渐锥度,以便允许插塞130、230和端板140、150或240、250之间更容易相互作用。举例来说,如大体上在图3的部分拆分视图(其中去除第一端板140)中示出,远端头部分135包含适合于促使在端板140、150的内侧上的互补斜坡或波形表面153的斜坡136或楔(参见图3A,示出一个具有形成于其中的例示性斜坡153的端板150的分离视图),以便在插塞130沿植入物10的长度L向远端推进时逐渐移动端板140远离框架100。类似地,在图5-8中示出的实施例中,远端头部分235可为锥形以提供可被优化具有锥度的导入或截头圆锥形形状,所述锥度当促使端板240、250远离框架200时允许实现机械优点。举例来说,在图6中示出植入物20的所得打开配置。此外,应理解,多种斜坡和/或锥度配置可用于优化插塞130、230与端板140、150或240、250的相互作用。这类配置可包括但不限于:具有不同角度的连续斜坡或锥形截头圆锥形表面;通向较高角度连续斜坡或锥形截头圆锥形表面的小角度连续斜坡或锥形截头圆锥形表面(一旦已实现植入物10的初始扩张就提高机械优点),以及其它打开机构(如大体上在图2-4中示出的侧向杆137和轨道155系统,其可组合以辅助斜坡136(和153,参见图3A)使植入物20扩张)。
如在图2-4中示出,在可扩张脊柱植入物10的一些实施例中,远端头部分135可包含侧向杆137,所述侧向杆137从插塞130的远端头部分135延伸并且被配置成用于与限定在端板140、150中的对应通道145、155协作。通道可成角度或部分成角度以在插塞130沿植入物10的长度L向远端推进时提供额外的机构用于辅助植入物10的扩张。更具体地参考图2,第一端板140可限定至少一个侧向通道145,所述至少一个侧向通道145被配置成接收侧向杆137,使得当插塞130沿长度L在远端方向上移动时,远端头部分135的侧向杆137在侧向通道145中在第一方向上移动以使第一端板140从框架100向外扩张。杆131和通道145机构还可辅助使得植入物10扩张基本上可逆,使得当插塞130在近端方向上(即,朝向框架100的远端壁110)移动时,远端头部分135的侧向杆137在侧向通道145中在第二方向上移动以使第一端板140朝向框架100收缩(这可导致植入物10返回到大体上在图1中示出的闭合或未扩张配置)。插塞130的此可逆特征与带螺纹机构组合使植入物10能够通过基本上无限可调节的运动范围(仅通过插塞130的长度和由植入物10的端板限定的对应承载表面(例如参见图6的253)界定))逐渐扩张或收缩。
在一些实施例中,可扩张脊柱植入物系统10、20可被配置成可与插入仪器30一起操作和/或通过插入仪器30插入(例如大体上参见图17)。在一些这类实施例中,如在图9中示出,可扩张脊柱植入物10可包含框架100,所述框架100包含近端壁110和远端壁120。近端壁110可进一步限定近端孔洞111,并且远端壁110可进一步限定远端孔洞121。如本文所描述,近端孔洞111和远端孔洞121中的一个或两个可内部有螺纹以接收其它带螺纹组件。在一些实施例中,近端壁110可适于接收插入仪器30(或在一些情况下为插入仪器30的内部套管320,如在图9中示出)。
如本文所描述,可扩张脊柱植入物10还可包含可移动地安置在远端孔洞121中的插塞130,其中插塞130包含适于通过插入仪器30的至少一部分可操作地接合以移动插塞130的接口134。举例来说,在一些实施例中,插入仪器30可包含驱动器轴330,其中驱动器在所述驱动器轴330的远端端部(如内六角驱动器尖端)上。驱动器轴330的远端端部可与插塞130的接口134接合以使插塞在框架100的远端孔洞121中旋转,以便扩张植入物10。如本文所描述,植入物10的扩张可通过移动端板140、150实现,所述端板140、150通过框架100可操作地接合并且被配置成当插塞130通过插入仪器30(或其驱动器轴330)移动时相对于框架100移动。
如大体上在图17中示出,驱动器轴330可以共轴方式安置在插入仪器30的内部套管320内部。此外,驱动器轴330和内部套管320均可以共轴方式安置在插入仪器30的套管330内部。驱动器轴330、内部套管320和套管310中的每一个可进一步分别具备各种操控组件330'、320'和310',使得插入仪器30的各种组件可彼此独立操作和/或选择性操控以相对于植入物10进行各种功能(如本文进一步描述)。
如本文所描述和在图3和7的实施例中示出,框架100、200可进一步包含与框架100的近端壁110和远端壁120接合的至少一个侧壁104、204。侧壁104、204可被配置成使框架100的近端壁110和远端壁120沿植入物10、20的纵向轴线(平行于长度L延伸)隔开。在一些实施例中,如在图3中示出,框架100包含一对侧壁102、104,所述一对侧壁102、104侧向隔开并且与框架100的近端壁110和远端壁120接合以形成基本上闭合的区域,所述基本上闭合的区域适于接收和/或容纳可通过框架100的近端孔洞111放置的骨生长促进材料。在一些实施例中,插入仪器30的套管310或内部套管320可被配置成当植入物10处于扩张位置时(例如参见图2,其示出插塞130向远端向前移动并且离开由框架100限定的植入物10的近端区域)传送骨生长促进材料通过插入仪器30并且进入由框架100限定的区域中。
在一些实施例中,框架100可基本上借助侧壁“闭合”,如大体上在图9-12中示出。在其它实施例中,框架100可包含具有侧向孔洞的一对侧壁102、104,如大体上在图1-4中示出。在其它实施例中,如大体上在图5-8中示出,框架200可包含单侧或单个侧壁204,从而形成具有一个“打开”侧面的框架200。在如图8中示出的一些这类实施例中,框架200可适于至少部分容纳可通过框架200的近端孔洞211放置的骨生长促进材料BG和/或在框架200的近端壁210和远端壁220之间在侧向方向上引导在可扩张脊柱植入物20外的骨生长促进材料BG。
图9-12示出根据一个实施例的与插入仪器30一起使用以形成可扩张脊柱植入物系统的植入物10实施例的各种配置。如大体上在图9中示出,所述系统可包含插入仪器30,所述插入仪器30包含套管310(所述套管310可包括如本文所描述的内部套管320和外部套管310)和可移除且可旋转地安置在套管310内的驱动器轴330(参见图10和图17)。所述系统还可进一步包含被配置成使用多种机构与插入仪器30可操作地接合的可扩张脊柱植入物10。如本文所描述,植入物10包含框架100,所述框架100包含近端壁110和远端壁120,其中近端壁110限定近端孔洞111,并且远端壁120限定远端孔洞。近端壁110可被配置成接收套管310(或中间套管320)的远端端部用于操控可扩张脊柱植入物10。举例来说,如在图9中示出,套管310可包含叉尖311,所述叉尖311被配置成用于插入到由框架100的近端壁110限定的互补容座114中。在其它实施例中,叉尖311可与由端板140、150限定的接头或狭槽相互作用。叉尖311可与容座114相互作用以使得在植入物10与插入仪器的远端端部接合时外科医生能够有效操控植入物10。此外,在一些实施例中,内部套管320可包含带螺纹尖端321,所述带螺纹尖端321被配置成用于可操作地接合框架100的近端孔洞111的带螺纹内表面。在一些这类实施例中,在内部套管320旋转以接合框架100的近端孔洞111时,外部套管的叉尖311可充当有效反向转矩装置(防止植入物10相对于插入仪器30旋转)。图17示出相对于包括插入仪器的操控组件330'、320'和310'的植入物10的插入仪器30。举例来说,外部套管310的把手310'可用于即使在内部套管320的旋钮320'在外部套管310内旋转时稳定和/或操控植入物10,使得带螺纹尖端321可与框架100的近端孔洞111接合而不旋转植入物100。
如本文所描述,植入物10可被配置成用于借助可移动地安置在框架100的远端孔洞120中的插塞130扩张。在一些实施例中,插塞包含带螺纹外表面131,所述带螺纹外表面131被配置成与远端孔洞120的互补内部带螺纹表面接合。在一些实施例中,如在图9中示出,插塞130可包含接口134,所述接口134被配置成通过驱动器轴330的远端端部可操作地接合以相对于框架移动插塞130(例如通过带螺纹旋转)。驱动器轴330可以共轴方式放置在套管310和/或内部套管310内并且可使用驱动器轴330的驱动器近端端部330'在其中旋转。驱动器近端端部330'可包含刻面化或琢面化表面,所述刻面化或琢面化表面被配置成用于与快速释放把手(未示出)或电动驱动器(未示出)接合以旋转驱动器轴330。此外,插塞接口134可包含驱动容座,所述驱动容座被配置成与驱动器轴的远端端部协作。在驱动器轴330和插塞接口134之间的驱动连接可包含多种驱动接口,包括但不限于:多叶驱动器;内六角驱动器;十字形或菲利浦式头驱动器;笔直或“平头”驱动器;正方形或其它多边形驱动器;和/或其组合。
如本文所描述,当插塞130通过插入仪器30移动时,由驱动器轴310促进的插塞130在套管310内(并且在一些情况下在内部套管320内)的移动可进一步致使与植入物10的框架100可操作地接合的端板140、150相对于框架100移动。因此,插入仪器30(或驱动器轴330和驱动器近端端部330')可用于相对于框架100扩张端板140、150以便选择性地扩张植入物10和/或赋予邻近椎骨体V1、V2脊柱前凸移动,如在大体上图14和16中示出。可调节驱动器轴330的长度以适应框架100的远端壁120相对于植入物10的长度L的远端放置。举例来说,驱动器轴330可具备基本上超过套管310和/或内部套管320的长度的长度,使得驱动器近端端部330'保持可接入并且与把手或电动驱动器接合,甚至当植入物处于完全扩张状态时(参见图14和16)当驱动器轴330保持与植入物10的插塞130接合时也同样如此。此特征在以下情况下可能是重要的:外科医生希望使植入物10的扩张反向,如本文关于特定植入物10实施例的杆131和通道145机构进一步描述。
根据各种实施例,驱动器轴330还可被配置成可从套管310(和/或内部套管(如果采用的话))去除,使得在植入物10的插塞130已经相对于框架100向远端移动之后,骨生长促进材料BG可通过套管310(和/或通过同心内部套管320,当使用时)引入到可扩张脊柱植入物10的框架100中。骨生长促进材料BG可使用驱动器轴330或设定大小用于通过套管310和/或内部套管310可滑动插入的其它填塞器和/或杆(未示出)通过套管310或内部套管310而填塞或推动。漏斗(未示出)或其它附接件也可插入到套管310或内部套管320的近端端部中(如在接近内部套管320的近端端部或旋钮320'的点处,如在图17中示出)以促进骨生长促进材料BG引入到套管310和/或内部套管320中。
图9-12描绘在一个实施例中使用植入物系统的例示性程序步骤。举例来说,图9示出使用套管310的叉尖311和内部套管320的远端端部321附接到插入装置30的未扩张的植入物10。示出插塞130与框架的远端壁120的远端孔洞接合并且插塞接口134可见。在图10中,示出驱动器轴330延伸通过套管310和内部套管320并且与插塞接口134接合。参考图17,驱动器近端端部330'可在此步骤中旋转以向前驱动插塞130以使端板140、150相对于框架100扩张。图11示出驱动器轴330与插塞130的相互作用和插塞130相对于框架100的远端壁120的远端移动以使端板140、150相对于植入物10的框架100扩张的结果。图12示出插入装置30仍与植入物10接合,但是其中驱动器轴330从套管310和内部套管320去除,使套管打开用于通过插入仪器30引入骨生长促进材料BG并且引入到大体上由框架100的现在打开的内部限定的植入物10的近端部分中。
参考例示性图13-16,脊柱植入物系统10、30可用于手术关节融合术程序,例如用于治疗脊柱和体内相邻区域(例如在椎骨V1和椎骨V2之间的椎间盘间隙)的受感染区段的适用病况或受伤的椎体间融合。在一些实施例中,脊柱植入物系统10、30可包括椎间植入物,所述椎间植入物可插入有椎间盘间隙以间隔开关节接合表面、提供支撑并最大化椎骨V1、V2的稳定。在一些实施例中,脊柱植入物系统10、30可用于一个或多个椎骨。
医疗人员能够如通过切开和收缩组织而进入手术部位(包括椎骨V1、V2)。脊柱植入物系统10、30可用于任何现有手术方法或技术中,包括开放手术、迷你开放手术、微创手术和经皮手术植入,由此通过迷你切割、缩回器或为区域提供保护通道的套管或套筒进入椎骨V1、V2。在一个实施例中,脊柱植入物系统10、30的组件递送通过手术路径到达手术部位、沿手术途径进入在椎骨V1、V2之间的椎间盘间隙中。可使用各种手术途径和路径。图13示出使用脊柱植入物系统10、30的典型背侧腰椎椎体间融合(PLIF)途径的实例,其中可递送一对植入物10并使其扩张以赋予或恢复脊柱前凸弯曲(大体上参见图14),并且然后在从插入仪器30移除驱动器轴330之后后填充有骨生长促进材料BG。如在图15中示出,如椎间孔腰椎椎体间融合(TLIF)途径的单侧途径还可用于相对于椎骨V1、V2将植入物置于基本上倾斜位置。在这类程序中,端板140、150的远端端部144可被成型,使得植入物10配合在由椎骨体V2的范围限定的椎间间隙中,如在图15中示出。此外,在倾斜放置应用中,植入物10端板140、150还可具备互补倾斜接触表面,所述互补倾斜接触表面被成型以在植入物10扩张时更好地赋予和/或恢复脊柱前凸弯曲,如大体上在图16中示出。此外,植入物的端板140、150可具备多种脊、齿、涂层或适合于与邻近椎骨V1、V2相互作用和/或相对于邻近椎骨V1、V2紧固的其它表面处理物。
如本领域的技术人员应了解,可采用准备仪器(未示出)来移除椎间盘组织、流体、邻近组织和/或骨,并且从椎骨V1的端板表面和/或椎骨V2的端板表面擦除和/或移除组织以为利用系统10、30的程序做准备。在一些实施例中,在使用可估计系统10、30的大小和配置的试验仪器(未示出)进行试验之后,选择植入物10的大小(例如,如在图17中示出)。在一些实施例中,这类试验可能大小固定和/或可配备有类似于本文所描述的各种植入物10、20实施例的扩张机构。在一些实施例中,可通过透视而观测到植入物10并且在引入到椎间盘间隙中之前定向。此外,插入仪器30和植入物10可配备有基准标记以使得能够在程序之前和/或期间使用图像引导手术导航。
在如大体上在图13和15中示出的一些实施例中,植入物10提供改进稳定性并降低下沉到组织中的风险的占据面积。在如大体上在图14和16中示出的一些实施例中,植入物10提供在椎骨体之间的角度纠正、高度恢复、减压、矢状和/或冠状平衡的恢复和/或下沉到椎骨端板中的阻力。在一些实施例中,植入物10接合并且隔开椎骨V1、V2的相对端板表面,并且紧固在椎骨间隙内以稳定并固定椎骨V1、V2的部分,与用于融合并固定椎骨椎V1、V2的骨生长结合。
包括植入物10的脊柱植入物系统10、30的组件可递送或植入作为预组装装置或者可现场组装。包括植入物10的脊柱植入物系统10、30的组件可现场扩张、收缩、完全或部分修正、去除或替换。在一些实施例中,脊柱植入物系统10、30的组件中的一个或全部可经由机械操控和/或徒手技术递送到手术部位。
在一个实施例中,脊柱植入物系统10、30包括多个植入物10(针对一个实例,参见图13)。在一些实施例中,采用多个植入物10可优化在椎骨V1、V2之间的角度纠正和/或高度恢复。多个植入物10可定向成并排接合、间隔开和/或错开。
在一些实施例中,脊柱植入物系统10、30包括试剂,包括但不限于本文所描述的骨生长促进材料BG,所述试剂可安置、包装、涂布或层压在脊柱植入物系统10、30的组件和/或表面内、其上或其周围。在一些实施例中,试剂可包括骨生长促进材料以增强植入物10与骨结构的固定。在一些实施例中,所述试剂可包括用于释放(包括缓释)的一种或多种治疗剂和/或药剂,以治疗(例如)疼痛、炎症和退化。
在一个实施例中,植入物10、20可包括紧固元件,所述紧固元件可包括锁定结构,所述锁定结构被配置成用于与椎骨V1、V2固定以紧固接合表面并且向椎骨区域提供互补稳定性和不移动性。在一些实施例中,锁定结构可包括紧固元件,例如杆、板、夹具、钩、粘合剂和/或凸缘。在一些实施例中,脊柱植入物系统10、30的组件可与螺钉一起使用以增强固定。脊柱植入物系统10的组件可由如聚合物的射线可透过材料制成。可包括不透射线标记用于x射线、荧光检查、CT或其它成像技术的识别。
在一些实施例中,可采用显微手术、微创和图像引导技术的使用来借助脊柱植入物系统10、30进入、查看并修复脊柱恶化或损伤。一旦完成程序,就可去除脊柱植入物系统10、30的非植入组件、手术仪器和组合件(如插入仪器30)并且闭合切口。在一些实施例中,所公开的各种仪器(如大体上在本文的图9和相关附图中公开的插入仪器)可具备基准标记或适合与手术导航系统(包括但不限于可购自美敦力公共有限公司的导航系统)一起使用的其它元件,使得外科医生可实时和/或几乎实时地查看植入物10、20相对于患者的身体结构的投射轨迹或插入路径。
应理解,可扩张脊柱插入物10、20的各种独立组件、本文所描述的系统和插入仪器30可根据各种实施例以不同方式组合。作为非限制性实例,关于植入物20在图5-8中示出的凹槽114也可添加到在图1-4中示出的植入物10的近端端部。作为另外的非限制性实例,关于植入物20的端板240、250在图5-8中示出的双孔洞241a、241b、251a、251b也可添加到在图1-4中示出的植入物10的端板140、150。
应理解,可对本文所公开的实施例作出各种修改。因此,上文的描述不应解释为限制性的,而仅仅是作为各种实施例的例证。本领域的技术人员将设想在此文档中的权利要求书的范围和精神内的其它修改。

Claims (20)

1.一种可扩张脊柱植入物,所述可扩张脊柱植入物配置成在椎间盘空间中在收缩位置和扩张位置之间展开,所述椎间盘空间在上下椎骨之间,所述可扩张脊柱植入物包括:
近端、相对的远端、在所述近端和所述远端之间的长度、以及延伸穿过所述近端和所述远端的中间纵向轴线;
框架,所述框架具有框架近端、相对的框架远端、以及设置在所述框架远端处的远端孔洞;
插塞,所述插塞可移动地安置在所述远端孔洞中,且配置成用于从所述植入物的所述近端和所述远端中间的位置朝所述植入物的所述远端运动,所述插塞包括头部分,所述头部分包括至少一个第一侧向杆部分和至少一个第二侧向杆部分;
第一端板,所述第一端板与所述框架枢转地接合并且被配置成随着所述插塞在远端方向上移动而从所述框架向外枢转,所述第一端板包括上表面、第一端板近端、第一端板远端、以及至少一个第一细长且倾斜的通道,所述第一细长且倾斜的通道形成在所述第一端板中,且从第一位置延伸到第二位置,且配置成接纳所述至少一个第一侧向杆部分,所述第一位置定位在离开所述上表面第一距离处,并处于所述植入物的所述近端和所述远端之间的大致中点处,所述第二位置定位在离开所述上表面大于所述第一距离的第二距离处,并处于所述中点和所述植入物的所述远端之间的大致半途处;以及
第二端板,所述第二端板与所述框架枢转地接合并且被配置成随着所述插塞在所述远端方向上移动而从所述框架向外枢转,所述第二端板包括下表面、第二端板近端、第二端板远端、以及至少一个第二细长且倾斜的通道,所述第二细长且倾斜的通道形成在所述第二端板中,且从第三位置延伸到第四位置,且配置成接纳所述至少一个第二侧向杆部分,所述第三位置定位在离开所述下表面第三距离处,并处于所述植入物的所述近端和所述远端之间的大致所述中点处,所述第四位置定位在离开所述下表面大于所述第三距离的第四距离处,并处于所述中点和所述植入物的所述远端之间的大致半途处;
其中,所述至少一个第一细长且倾斜的通道具有位于第一平面中的纵向轴线,所述第一平面横向于所述植入物的所述中间纵向轴线,所述至少一个第一侧向杆部分位于所述至少一个第一细长且倾斜的通道中并与所述第一端板的在所述至少一个第一细长且倾斜的通道周围的部分直接接合,所述至少一个第二细长且倾斜的通道具有位于第二平面中的纵向轴线,所述第二平面横向于所述植入物的所述中间纵向轴线,且所述至少一个第二侧向杆部分位于所述至少一个第二细长且倾斜的通道,并且与所述第二端板的在所述至少一个第二细长且倾斜的通道周围的部分直接接合,并且所述插塞的运动朝向所述植入物的所述远端;以及
其中,所述至少一个第一侧向杆部分在所述至少一个第一细长且倾斜的通道中的相互作用引起所述第一端板远离所述框架而枢转,而所述至少一个第二侧向杆部分在所述至少一个第二细长且倾斜的通道中的相互作用引起所述第二端板远离所述框架而枢转,从而使所述植入物从所述收缩位置运动到所述扩张位置。
2.根据权利要求1所述的可扩张脊柱植入物,其特征在于,所述框架包括近端壁、远端壁和侧壁,所述侧壁配置成沿着所述可扩张脊柱植入物的所述中间纵向轴线将所述近端壁和所述远端壁间隔开。
3.根据权利要求2所述的可扩张脊柱植入物,其特征在于,所述近端壁限定近端孔洞,并且所述框架的所述远端壁远离所述植入物的所述近端安置在所述长度的至少三分之一处,使得所述植入物的近端部分保持打开并且与所述框架的所述近端孔洞流体连通,使得可通过所述框架的所述近端孔洞放置骨生长促进材料。
4.根据权利要求2所述的可扩张脊柱植入物,其特征在于,所述第一端板包括从所述上表面延伸到第一内表面的第一孔洞,所述第二端板包括从所述下表面延伸到第二内表面的第二孔洞,所述第一孔洞和所述第二孔洞有助于骨穿过所述可扩张脊柱植入物而长入。
5.根据权利要求4所述的可扩张脊柱植入物,其特征在于,在所述框架的所述近端壁、所述远端壁和所述侧壁之间限定有腔体,且所述腔体与所述第一端板的所述第一孔洞和所述第二端板的所述第二孔洞流体连通。
6.根据权利要求1所述的可扩张脊柱植入物,其特征在于,所述插塞包括外部带螺纹表面,且其中所述远端孔洞包括内部带螺纹表面,所述内部带螺纹表面与所述插塞的所述外部带螺纹表面可操作地配合。
7.根据权利要求1所述的可扩张脊柱植入物,其特征在于,所述头部分配置成,在所述插塞沿远端方向移动时接触并推动所述第一端板和所述第二端板远离所述框架地枢转。
8.根据权利要求4所述的可扩张脊柱植入物,其特征在于,所述头部分为楔形,带有上表面和下表面,所述上表面配置成与所述第一端板的内表面相接触,所述下表面配置成与所述第二端板的内表面接触。
9.根据权利要求1所述的可扩张脊柱植入物,其特征在于,所述第一端板包括邻近所述第一端板远端的第一端部分,所述第二端板包括邻近所述第二端板远端的第二端部分,所述第一端部分从所述上表面到所述第一端板远端渐缩,以形成第一楔形,所述第二端部分从所述下表面到所述第二端板远端渐缩,以形成第二楔形。
10.一种可扩张脊柱植入物,所述可扩张脊柱植入物配置成在椎间盘空间中在收缩位置和扩张位置之间展开,所述椎间盘空间在上下椎骨之间,所述可扩张脊柱植入物包括:
近端、相对的远端、在所述近端和所述远端之间的长度、以及延伸穿过所述近端和所述远端的中间纵向轴线;
框架,所述框架具有框架近端、相对的框架远端、以及设置在所述框架远端处的远端孔洞;
插塞,所述插塞可移动地安置在所述远端孔洞中,且配置成用于从所述植入物的所述近端和所述远端中间的位置朝所述植入物的所述远端运动,所述插塞包括头部分,所述头部分包括至少一个第一侧向杆部分;以及
端板,所述端板与所述框架枢转地接合并且被配置成随着所述插塞通过插入仪器在远端方向上的移动而相对于所述框架移动,所述端板包括外表面、端板近端、端板远端、以及至少一个第一细长且倾斜的通道,所述第一细长且倾斜的通道形成在所述端板中,从第一位置延伸到第二位置,且配置成接纳所述至少一个第一侧向杆部分,所述第一位置定位在离开所述外表面第一距离处,并处于所述植入物的所述近端和所述远端之间的大致中点处,所述第二位置定位在离开所述外表面大于所述第一距离的第二距离处,并处于所述中点和所述植入物的所述远端之间的大致半途处;
其中,所述至少一个第一细长且倾斜的通道具有位于第一平面中的纵向轴线,所述第一平面横向于所述植入物的所述中间纵向轴线,所述至少一个第一侧向杆部分位于所述至少一个第一细长且倾斜的通道中,并与所述端板的在所述至少一个第一细长且倾斜的通道周围的部分直接接合;以及
其中,所述插塞朝向所述植入物的所述远端的运动以及所述至少一个第一侧向杆部分在所述至少一个第一细长且倾斜的通道中的对应相互作用引起所述端板远离所述框架的运动,以使所述植入物从所述收缩位置运动到所述扩张位置。
11.根据权利要求10所述的可扩张脊柱植入物,其特征在于,所述框架包括近端壁、远端壁和侧壁,所述侧壁配置成沿着所述可扩张脊柱植入物的所述中间纵向轴线将所述近端壁和所述远端壁间隔开。
12.根据权利要求11所述的可扩张脊柱植入物,其特征在于,所述近端壁限定近端孔洞,并且所述框架的所述远端壁远离所述植入物的所述近端安置在所述长度的至少三分之一处,使得所述植入物的近端部分保持打开并且与所述框架的所述近端孔洞流体连通,使得可通过所述框架的所述近端孔洞放置骨生长促进材料。
13.根据权利要求11所述的可扩张脊柱植入物,其特征在于,所述端板包括从所述外表面延伸到内表面的孔洞,所述孔洞有助于骨穿过所述可扩张脊柱植入物而长入。
14.根据权利要求13所述的可扩张脊柱植入物,其特征在于,在所述框架的所述近端壁、所述远端壁和所述侧壁之间限定有腔体,且所述腔体与所述端板的所述孔洞流体连通。
15.根据权利要求10所述的可扩张脊柱植入物,其特征在于,还包括第二端板,所述第二端板与所述框架枢转地接合,并且配置成当所述插塞朝远端方向运动时相对于所述框架运动。
16.根据权利要求10所述的可扩张脊柱植入物,其特征在于,所述插塞包括外部带螺纹表面,且其中所述远端孔洞包括内部带螺纹表面,所述内部带螺纹表面与所述插塞的所述外部带螺纹表面可操作地配合。
17.根据权利要求10所述的可扩张脊柱植入物,其特征在于,所述头部分配置成,在所述插塞沿远端方向移动时接触并推动所述端板远离所述框架地枢转。
18.根据权利要求17所述的可扩张脊柱植入物,其特征在于,所述头部分为楔形,带有配置成与所述端板的内表面接触的外表面。
19.根据权利要求10所述的可扩张脊柱植入物,其特征在于,所述端板包括邻近所述端板远端的第一端部分,所述第一端部分从所述外表面向所述端板远端渐缩,以形成楔形。
20.一种可扩展的脊柱植入物系统,所述植入物系统包括:
插入仪器,所述插入仪器包括套管和驱动器轴;
可扩张脊柱植入物,所述可扩张脊柱植入物配置成在椎间盘空间中在收缩位置和扩张位置之间展开,所述椎间盘空间在上下椎骨之间,所述可扩张脊柱植入物包括:
近端、相对的远端、在所述近端和所述远端之间的长度、以及延伸穿过所述近端和所述远端的中间纵向轴线;
框架,所述框架具有框架近端、相对的框架远端、以及设置在所述框架远端处的远端孔洞;
插塞,所述插塞可移动地安置在所述远端孔洞中,且配置成用于从所述植入物的所述近端和所述远端中间的位置朝所述植入物的所述远端运动,所述插塞包括头部分,所述头部分包括至少一个第一侧向杆部分,且所述插塞包括接口,所述接口配置成由所述驱动器轴的远端可操作地接合以使所述插塞相对于所述框架运动;以及
端板,所述端板与所述框架枢转地接合并且被配置成随着所述插塞通过插入仪器在远端方向上的移动而相对于所述框架移动,所述端板包括外表面、端板近端、端板远端、以及至少一个第一细长且倾斜的通道,所述第一细长且倾斜的通道形成在所述端板中,从第一位置延伸到第二位置,且配置成接纳所述至少一个第一侧向杆部分,所述第一位置定位在离开所述外表面第一距离处,并处于所述植入物的所述近端和所述远端之间的大致中点处,所述第二位置定位在离开所述外表面大于所述第一距离的第二距离处,并处于所述中点和所述植入物的所述远端之间的大致半途处;
其中,所述至少一个第一细长且倾斜的通道具有位于第一平面中的纵向轴线,所述第一平面横向于所述植入物的所述中间纵向轴线,所述至少一个第一侧向杆部分位于所述至少一个第一细长且倾斜的通道中,并与所述端板的在所述至少一个第一细长且倾斜的通道周围的部分直接接合;
其中,所述插塞朝向所述植入物的所述远端的运动以及所述至少一个第一侧向杆部分在所述至少一个第一细长且倾斜的通道中的对应相互作用引起所述端板远离所述框架的运动,以使所述植入物从所述收缩位置运动到所述扩张位置;以及
其中,所述驱动器轴配置成能够从所述套管拆下,从而在所述插塞已经相对于所述框架向远侧运动时,能够通过所述套管将骨生长促进材料放到所述可扩张脊柱植入物的所述框架中。
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