CN101657171B - 椎间盘假体插入组件 - Google Patents

椎间盘假体插入组件 Download PDF

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Publication number
CN101657171B
CN101657171B CN2008800116710A CN200880011671A CN101657171B CN 101657171 B CN101657171 B CN 101657171B CN 2008800116710 A CN2008800116710 A CN 2008800116710A CN 200880011671 A CN200880011671 A CN 200880011671A CN 101657171 B CN101657171 B CN 101657171B
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China
Prior art keywords
prosthesis
adapter
prosthese
intervertebral disc
intervertebral
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Expired - Fee Related
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CN2008800116710A
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CN101657171A (zh
Inventor
A·乔代提斯
H·汀威尔
A·摩西尔
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LDR Medical SAS
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LDR Medical SAS
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    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0085—Identification means; Administration of patients
    • A61F2250/0086—Identification means; Administration of patients with bar code
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0085—Identification means; Administration of patients
    • A61F2250/0089—Identification means; Administration of patients coded with symbols, e.g. dots, numbers, letters, words
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Abstract

在各种实施例中，提供椎间盘假体(104)。假体(104)可以被装备有插入适配器(106)，诸如假体(104)的头部、支架或其他载体。插入适配器(106)可以被配置成固定假体(104)并且接合插入工具本体(130)。在各种实施例中，假体(104)和插入支架被提供在无菌包(102，202)内且假体(104)部件和插入支架被消毒和包装在一种或更多种的类型或层的无菌包装(103a，103b)内。在各种其他实施例中，假体(104)和插入工具(131)被提供在无菌包(102，202)内且假体(104)部件和插入工具(131)被消毒和包装在一种或更多种的类型或层的无菌包装(103a，103b)内。

Description

椎间盘假体插入组件
技术领域
本发明涉及假体领域，并且具体涉及用来代替天生椎间盘的椎间盘假体。
背景技术
健康的椎间盘是足够柔韧的以允许在邻近的椎骨之间或椎骨与另一个邻近的脊柱元件之间运动，所述脊柱元件诸如尾椎骨(脊柱的最下面部分，由4块尾椎融合而成)和骶骨(三角骨，即是形成骨盘的后部的骸骨元件，其由5块融合的椎骨形成)。该运动可以适应脊柱的弯曲。天生椎间盘组织的疾病或退化经常导致剧痛和可动性被降低。当天生椎间盘的退化或疾病发展成非手术治疗(诸如药物、注射、和/或物理治疗)无效的地步时则需要外科手术。
治疗退化或病态的椎间盘的常用方法包括移除天生的椎间盘组织并且融合邻近的椎骨。但是，融合消除了邻近椎骨之间的可动性，并且可能将应力和运动转移到融合点上面和/或下面的椎间盘。
椎间盘假体已经发展到减轻由椎间融合产生的问题。具体地，椎间盘假体的各种设计可以提供给邻近的椎骨相对正常范围的运动，从而沿着脊柱各个部分产生更正常的应力和运动分布。椎间盘假体通常被配置为恢复正常的椎间盘高度，并且能够减轻融合方法中通常存在的术后固定仪器的手术发病率和复杂性。
专利FR 2824261、FR 2846550、FR 2865629和专利申请FR2893838(对应于申请WO 02/089701、WO 04/041129、WO 2005/074839、WO 2007063398和美国专利申请Nos.10/476,565、10/533,846、11/051,710和11/362,253)，其每一个都被转让给本申请的受让人，并且其每一个实际上都通过参考合并于此，上述专利和专利申请公开了各种椎间盘假体结构。在许多这些结构中，假体可以具有支撑上椎骨的上板、支撑下椎骨的下板和移动核芯或移动核心，该移动核芯或移动核心在上板和下板之间提供一定程度的关节运动。
在手术植入过程之前，通常测量上椎骨和下椎骨的板以确定过程的生存力(viability)。下面的各种代表性方法中的椎间盘摘除，测量椎骨空间的深度和宽度，并且确定邻近椎骨的合适的垂直间隔和上下盘假体板和核芯的尺寸。
一般地，根据椎间盘假体的类型，椎骨假体板的深度和宽度及核芯的高度可以有多种选择。例如，目前的LDR Medical Mobi-C(tm)颈椎间盘假体可以被配置成具有4种板尺寸和3种核芯高度中的任何尺寸和高度，并且目前的LDR Medical Mobidisc(tm)腰椎间盘假体可以被配置成具有18种板尺寸和6种核芯高度中的任何尺寸和高度。此外，外科医生可能希望通过使用一个或更多个板来调整或矫正脊柱前凸和后凸，该一个或更多个板在板的脊椎接触面的法线所示的脊椎轴和板的核芯接触面所示的中轴或中性轴、法线轴之间具有角度偏差。因此，即使在单个生产线内，可以有许多单个盘假体元件的组合用来满足具体病人的需要。在各种椎间假体生产系统中，上板、下板和核芯被单独地提供给手术室的无菌区。一旦上板、下板和核芯的合适配置被确定，则医护人员通常必须从库存中取得合适的上板、下板和核芯。
假体的部件一般被组装为用以安装假体插入工具或装入假体插入工具，或直接装配有插入工具，在一些系统中，装配台或装配夹具用于组装假体部件和将组装的假体装入插入工具内。选择和组装过程可能费时费力，从而在手术过程期间可能导致延迟。在组装过程期间操作部件可能危害假体的无菌性，并且使用额外的操作装置，诸如装配台或装配夹具，可能需要进一步消毒过程，增加了过程的复杂性，并且弄乱了手术室。
在一些系统中，每种插入工具都被配置成使用单一尺寸或受限范围尺寸的各种假体部件的组合。通常，直到开始外科手术时，才能知道各种假体部件的所需尺寸和结构。因此，外科医生在确定各种假体部件的合适尺寸和结构后，在手术期间不得不选择合适的插入工具。因此，医护人员必须消毒和杀菌多种插入工具以在手术期间在手边可以有全面选择的插入工具。在手术期间，选择合适的工具和确认选择将增加外科手术的持续时间和复杂性。然而，在各种插入工具的设计中，插入工具本体的操作部件可以是相同的而不必考虑假体的结构，而仅仅工具的插入适配器(例如，已组装假体的头部、支架或其他载体)因不同的插入工具而不同。通常，各种插入适配器之间的差异由假体部件的尺寸和结构的差异单独地控制。
发明内容
在本文中，本发明的一个目的是通过提出一种椎间盘假体输送和插入系统来克服现有技术的缺点，其中该椎间盘假体输送和插入系统便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间被直接使用。
通过椎间盘假体输送和插入系统可以实现本发明的目的，该系统包括：(a)可拆卸的插入工具本体；及(b)多个椎间盘假体插入组件，每一个在无菌包装中被杀菌和包装以形成无菌包，其每一个包括：(i)插入适配器，其具有联接器以用于可拆卸的插入工具本体，及(ii)椎间盘假体，其可释放地安装于所述插入适配器。
根据另一个具体特征，椎间盘假体具有尺寸和结构规格。
根据另一个具体特征，本系统进一步包括库存存储空间，其具有用于所选尺寸和结构规格的存储位置。
根据另一个具体特征，当相应无菌包被存储在库存存储空间时，每个无菌包均具有可观察的标识信息。
根据另一个具体特征，每个存储位置对应于所选的尺寸和结构规格中的一个。
根据另一个具体特征，每个椎间盘假体包括：-第一板，其具有从第一尺寸和结构规格组中选择的尺寸和结构；-第二板，其具有从第二尺寸和结构规格组中选择的尺寸和结构，及-核芯，其具有从第三尺寸和结构规格组中选择的尺寸和结构。
根据另一个具体特征，该第一尺寸和结构规格组与该第二尺寸和结构规格组相同。
根据另一个具体特征，该第一尺寸和结构规格组、该第二尺寸和结构规格组和该第三尺寸和结构规格组中的一个或更多个仅包含一个元件。
根据另一个具体特征，该系统进一步包括库存存储空间，其具有用于第一尺寸和结构规格、第二尺寸和结构规格以及第三尺寸和结构规格的所选组合的存储位置。
根据另一个具体特征，当相应初级无菌包被存储在库存存储空间时，每个初级无菌包均具有可观察的标识信息。
根据另一个具体特征，每个存储位置对应于第一尺寸和结构规格、第二尺寸和结构规格以及第三尺寸和结构规格的所选组合中的一个。
根据另一个具体特征，当位置是空的时每个存储位置均具有可观察信息，所述信息标识第一尺寸和结构规格、第二尺寸和结构规格以及第三尺寸和结构规格的所选组合中与此位置相对应的一个。
本发明的另一个目的是通过提出一种椎间盘假体插入组件来克服现有技术的缺点，其中该椎间盘假体插入组件便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间直接使用。
通过椎间盘假体插入组件可以实现此目的，该组件包括插入适配器和椎间盘假体，该插入适配器具有用于可拆卸的插入工具本体的联接器，该椎间盘假体通过插入适配器被可释放地保持。
根据另一个具体特征，插入适配器和椎间盘假体被设置在无菌包装内以形成无菌包。
根据另一个具体特征，插入适配器具有与椎间盘假体互补并且基本适合椎间盘假体的表面。
根据另一个具体特征，插入适配器具有至少一个固定器，所述至少一个固定器接合椎间盘假体的凹槽和/或柱。
根据另一个具体特征，固定器是一个掣子，并且凹槽设置在椎间盘假体的板的边缘上。
根据另一个具体特征，固定器是一个栓钉(dog)，并且凹槽沿着椎间盘假体的核芯设置。
根据另一个具体特征，栓钉具有一个通道，其基本与椎间盘假体板的柱的边缘匹配。
本发明的另一个目的是通过提出一种被包装的椎间盘假体插入组件来克服现有技术的缺点，该被包装的椎间盘假体插入组件便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间直接使用。
通过被包装的椎间盘假体插入组件可以实现此目的，该组件包括其内设置有无菌插入适配器的无菌包和无菌椎间盘假体部件，该无菌插入适配器具有联接器用于可拆卸的插入工具本体。
根据另一个具体特征，椎间盘假体的部件通过插入适配器被组装并且被保持。
本发明的另一个目的是通过提出一种椎间盘假体插入系统克服现有技术的缺点，其中该椎间盘假体插入系统便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间直接使用。
通过椎间盘假体插入系统可以实现此目的，该系统包括：-插入适配器，其具有联接器用于可拆卸插入工具本体；及-椎间盘假体，其可释放地安装在插入适配器。
根据另一个具体特征，插入适配器和椎间盘假体被设置在无菌包装中以形成无菌包。
根据另一个具体特征，插入工具本体包括插入致动器。
根据另一个具体特征，插入工具本体包括插入止挡件。
根据另一个具体特征，插入止挡锁是可调整的。
根据另一个具体特征，插入工具本体包括插入止挡锁。
本发明的另一个目的是通过提出一种椎间盘假体插入方法克服现有技术的缺点，其中该椎间盘假体便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间直接使用。
通过在邻近的脊柱元件之间插入椎间盘假体的方法可以实现此目的，该方法的步骤包括：-提供一种插入适配器和一种椎间盘假体；-将椎间盘假体安装到插入适配器以形成插入组件；-提供一种插入工具本体；-将插入组件安装到插入工具本体；在邻近的脊柱元件之间插入椎间盘假体；及-从插入组件拆除椎间盘假体。
根据另一个具体特征，该方法的步骤进一步包括从插入工具本体上拆除插入适配器并且丢弃插入适配器。
通过在邻近的脊柱元件之间插入椎间盘假体的方法也可以实现此目的，该方法的步骤包括：-提供插入适配器和椎间盘假体部件；组装椎间盘假体部件和插入适配器以形成插入组件；提供插入工具本体；-组装插入组件和插入工具本体；将椎间盘假体置于邻近的脊柱元件之间；及-从插入组件拆除椎间盘假体。
根据另一个具体特征，提供插入适配器和椎间盘假体部件的步骤包括：-在无菌包装中包装椎间盘假体部件和插入适配器以形成无菌包；然后-将无菌包传输到无菌区。
根据另一个具体特征，该方法的步骤进一步包括：-在无菌包装中包装插入组件以形成无菌包；然后-将无菌包传输到无菌区。
通过在无菌条件下将椎间盘假体插入组件输送到无菌区的方法也可以实现此目的，该方法的步骤包括：-提供无菌的椎间盘假体部件和无菌插入适配器，该无菌插入适配器具有联接器用于可拆除插入工具本体；-在无菌包装中包装椎间盘假体部件和插入适配器以形成初级无菌包；-将包含椎间盘假体和插入适配器的无菌包输送到无菌区；及-从无菌区内的无菌包拆除椎间盘假体和插入适配器。
根据另一个具体特征，该方法进一步包括：在包装步骤之前，组装椎间盘假体部件和插入适配器的步骤。
根据另一个具体特征，该方法的步骤进一步包括将初级无菌包包装成二级无菌包的步骤。
本发明的另一个目的是通过提出被包装的椎间盘假体插入组件来克服现有技术的缺点，该椎间盘假体插入组件易于使用并且可以被提供在托盘中，该托盘可以在手术过程期间直接使用。
通过被包装的椎间盘假体插入组件可以实现此目的，该被包装的椎间盘假体插入组件包括无菌包和无菌的椎间盘假体部件，其中无菌插入工具被设置在所述无菌包内。
根据另一个具体特征，椎间盘假体部件与无菌插入工具组装起来。
本发明的另一个目的是通过提出一种椎间盘假体插入系统来克服现有技术的缺点，其中该椎间盘假体插入系统便于使用并且可以被提供在托盘中，该托盘可以在手术过程期间被直接使用。
通过包括多个被包装的椎间盘假体插入组件的椎间盘假体输送和插入系统可以实现此目的，每个被包装的椎间盘假体插入组件均包括被包装在无菌包装内以形成初级无菌包的无菌插入工具和椎间盘假体的无菌部件。
根据另一个具体特征，每个椎间盘假体具有一个尺寸和结构规格。
根据另一个具体特征，系统进一步包括库存存储空间，其具有存储位置以用于所选多个尺寸和结构规格。
根据另一个具体特征，当各个初级无菌包被存储在库存存储空间时，每个初级无菌包均具有可观察的标识信息。
根据另一个具体特征，每个存储位置对应于所述所选多个尺寸和结构规格中的一个。
在各种实施例中，提供椎间盘假体。假体可以具有插入适配器，诸如假体的头部、支架或其他载体。插入适配器可以被配置成固定假体并且接合插入工具本体。在各种实施例中，假体和插入支架被提供在无菌包内，且在一种或多于一种类型或一层或多于一层的无菌包装内消毒并包装假体部件和插入固定架。椎间盘假体插入组件、椎间盘假体插入系统、椎间盘输送和插入系统、将椎间盘假体插入脊柱的邻近元件之间的方法、将椎间盘假体插入脊柱的邻近元件之间的方法以及将椎间盘假体插入组件无菌地输送到无菌区的方法也都被公开。
附图说明
在阅读下面描述并且参考附图，本发明各个实施例和各个方面的其他特征和优点对本领域的技术人员将变得更清楚：图1描述包括假体插入组件的无菌包的实施例。图2描述假体插入组件的实施例。图3描述假体插入组件的实施例的细节。图4描述了插入工具本体的实施例。图5A和图5b描述插入工具本体和假体插入组件实施例的部件。图6A、图6B和图6C描述插入工具本体实施例的各个视图。图7描述假体插入组件和插入工具本体的支撑件的实施例。图8描述插入工具本体实施例的一部分和其部件。图9描述假体插入组件和插入工具本体的支撑件的实施例。图10描述假体插入组件和插入工具本体的支撑件的实施例。图11描述假体插入组件和插入工具本体的支撑件的实施例。图12描述可拆除工具的实施例。图13描述假体插入组件和可拆除工具的实施例。图14描述椎间盘假体、插入适配器和可拆除工具的实施例。图15描述库存存储空间和存储位置的实施例。图16描述存储位置和结构信息的实施例。图17描述包括假体插入组件的无菌包的实施例。图18A、图18B和图18C分别描述假体插入组件实施例的正视图、沿着图18A的剖面(18B-18B)的横截面图和沿着图18B的剖面(18C-18C)的横截面图。图19A和图19B分别描述被组装和被拆开的假体插入组件实施例的透视图。图20A、图20B和图20C分别描述假体插入组件实施例的正视图、沿着图20A的剖面(20B-20B)的横截面图和沿着图20B的剖面(20C-20C)的横截面图。图21A和图21B分别描述被拆开的假体插入组件实施例和插入适配器实施例的透视图。图22A、图22B和图22C根据各个实施例，分别描述椎间盘假体的第一板的正视图、椎间盘假体的第二板的侧视图和椎间盘假体的第二板的正视图。图23A、图23B和图23C分别描述假体插入组件实施例的正视图、沿着图23A的剖面(23B-23B)的横截面图和沿着图23B的剖面(23C-23C)的横截面图。图24A和图24B分别描述被组装和被拆开的假体插入组件实施例的透视图。图25A和图25B分别描述被组装和被拆开的假体插入组件实施例的透视图。图26A和图26B分别描述图25A中参考标记26A所指示的假体插入组件部分的细节的侧视图和沿着图26A的假体插入组件的剖面(26B-26B)的横截面图；图26C和图26D分别描述图25A中参考标记26C所指示的假体插入组件部分的细节的侧视图和沿着图26B的假体插入组件的剖面(26D-26D)的横截面图。
具体实施方式
在本发明的多个实施例中，假体插入组件被设置成在插入过程期间可能从不直接接触假体。此设置的具体优点是其限制或阻止在插入过程期间污染假体插入组件的危险。提供无菌包装或无菌假体插入组件的各种实施例以帮助将假体插入到邻近的椎骨之间，并且以便于外科医生可以使用组件将假体插入而不与假体有任何直接接触。图1描述被包装的椎间盘假体插入组件(101)的许多可能实施例中的一个。在此实施例中，无菌插入适配器(106)和椎间盘假体(104)的无菌部件可以被组装在一起以形成图2所示的无菌假体插入组件(100)，其被处理成在初级或内无菌包装(103a)和二级或外无菌包装(103b)内以形成无菌包(102)。椎间盘假体(104)的部件可以与插入适配器(106)组装并且被提供到手术室预先设置且以备使用的无菌区。应该理解形成无菌包(102，202)的初级(103a)和二级(103b)包装的结构是任意的并且本发明可以与其他包装结构一起使用，诸如仅包括一层、两层(如上述示例当认为初级包装和二级包装是层时)或多于两层的无菌包(102，202)，其中每层与其它层可能不同。下面解释的形成组件的各种元件可以以此种包装形式被包装，诸如被组装或未被组装，且优选至少所有假体部件被组装，例如被安装到适配器，例如通过插入工具被夹持。使用此种结构，无菌包被输送到无菌区以移植到病人体内，并且在插入过程期间假体部件将不被接触，从而限制被污染的风险。
图2描述插入组件(100)的多个潜在实施例中的一个。插入组件(100)的各个实施例可以包括椎间盘假体(104)和插入适配器(106)，该插入适配器保持假体(104)并且与可分开或可拆除的外科手术工具本体(130)连接在一起、或安装在其上、或与其连接或接合，例如如图4所图示说明，该外科手术工具本体在移植假体(104)中使用。假体(104)可以是此处描述的由LDR Medical制造的类型或是由本申请的申请人(或对应的美国申请受让的申请的受让人)提交的专利FR 2824261、FR 2846550、FR 2865629、FR 2869528、FR 2879436(分别对应于申请WO 02/089701、WO 04/041129、WO 2005/074839、WO 2005/104996和WO 2006/120505)，或申请FR 2891135和FR2893838(分别对应于申请WO 2007/034310和WO 2007/063398)中的类型。此类假体可以包括：例如至少第一板、第二板和相对至少一个板旋转移动和/或平移移动的核芯，该核芯与至少一个板配合，以便限制或阻止核芯相对至少一个板的运动。本发明还可以包括另一种类型的假体，例如现有技术已知的类型并且可能包括在下述组件中使用的各种所需设置。在图4的实施例中，夹子(126)，例如如图3中所图示说明，为假体(104)的部件提供额外的约束。
图3显示假体(104)和插入适配器(106)实施例的分解图。此实施例中的假体(104)包括：第一板，诸如上板(108)；第二板，诸如下板(109)；和移动核芯(110)。“上板”和“下板”的结构通常是可逆的，并且当然对于将板指定为“第一板”和“第二板”或指定为“上板”和“下板”是纯粹地随机的。优选上板和下板(108，109)是由铬、钴和钼制成，但是也可以使用其他合成物。在各种优选实施例中，核芯可以由超高分子量的聚乙烯制成，但是也可以使用其他合成物制成。钛和羟磷灰石等离子喷涂涂层可以可选地被应用于上板和下板(108，109)的椎骨接触表面以促进通过骨长入或其他形式的附连到至少部分融合邻近的椎骨。在各种实施例中的假体(104)可以包含其他特征。例如，第二板(109)可以被配置成具有核芯止挡器，例如图示说明的柱(124)，其限制核芯(110)的平移和旋转移动。在此种实施例中，止挡器(124)和凹槽(122)之间沿着核芯本体周边的接触可以被配置为限制核芯(110)的平移和旋转移动。板(108，109)可以可选地具有成角度边缘(115)，其被配置为补偿与插入适配器(106)的可选成角度接触表面(116)的接触，其优点将在下面进行更详细地描述。
假体(104)的其他可选特征可以促进假体的移植和移植后的稳定性。例如，在假体插入期间假体(104)遇到椎骨(150)表面的边缘中的一个或多于一个边缘可以呈斜面，例如上板(108)和下板(109)的边缘(112)可以是斜面从而可以减少插入假体(104)所需的努力。可替换实施例可以完全不包含此倾斜，或可以仅在围绕板(108，109)周边的几个重要位置处呈斜面。各个实施例也可以具有锚(114)，例如，锚可以包括凹痕或齿，所述凹痕或齿被设置在假体(104)的一个或多于一个边缘的区域中的板(108，109)的一个板上或两个板上，或者一个或多于一个锚可以在沿着板(108，109)的椎骨接触表面中的一个表面或两个表面的任意地方。锚(114)可以以如下方式被配置，即可以使假体(104)移植期间，当假体随后反向移动时，所需的力最小。在假体(104)被植入后，锚(114)优选以多种方式稳定假体(104)和相对椎骨(150)的反向移动。例如，锚(114)可以提供齿在假体(104)和椎骨(150)之间主要沿拆除方向的反向移动，从而在假体植入后和撤回插入适配器(106)期间帮助将假体(104)保持在合适位置。板(108，109)的表面还可以具有多孔生物相容性涂层，例如如上所述，其还允许附粘到骨组织并且与假体融合。一旦骨组织附粘到板(108，109)上并且围绕锚(114)生长，则在假体(104)的每一个板(108，109)和各自邻近的椎骨(150)之间可以形成强连接。在替换的实施例中，多孔生物相容性涂层可以被多孔生物活性涂层替换或补偿，多孔生物活性涂层可以刺激骨组织的形成，并且/或者多孔生物相容性涂层可以被防腐涂层替换或补偿，防腐涂层可以防止或抵制植入表面的感染。
在椎间盘摘除(无论是完全或部分摘除)和牵引脊柱(诸如椎骨(150))的邻近元件后，假体移植手术过程可以包括测量椎间盘空间。这些测量可以用来确定被移植的上板(108)、下板(109)和移动核芯(110)的尺寸和结构。在各种实施例中，假体(104)通常可以被配置为协助矫正不同类型的脊柱变形，包括脊柱前凸和脊柱后凸。矫正脊柱前凸和脊柱后凸可以包括在后前方向的上板(108)和下板(109)之间施加一个角度，例如在0-15度之间的角度。上板(108)、下板(109)或核芯(110)可以被配置为协助施加一个角度，例如受让给本申请的受让人的专利FR 2824261中所讨论的。此角度可以被施加在上板和下板之间，因为核芯或核心具有施加角度的上表面和下表面(核芯的一个表面相对于另一个表面互相倾斜)或通过具有包括施加角度的上表面和下表面的至少一个板(至少一个板的一个表面相对于该板的另一个表面相互倾斜)。此外，板(108，109)和核芯(110)通常具有要被移植假体(104)的具体病人选择的尺寸和结构。通常，在实践中，直到开始手术过程，才知道假体(104)的尺寸和结构。因此，对于任何具体病人，医护人员需要在手边有分类的假体插入组件结构。
在各种实施例中，假体(104)的板(108，109)和核芯(110)可以通过插入适配器(106)固定或可拆卸地安装于插入适配器(106)。插入适配器(106)可以以多种方式配置，例如，诸如被组装的假体(104)的头部、支架或其他载体。插入适配器(106)可选地可以具有夹钳(121)，其通过抓住或箍缩假体上和下板的横向边来夹持假体。插入适配器(106)可以进一步包括一个或多于一个可选固定器，诸如安装栓钉(120)。栓钉(120)可以接合位于移动核芯(110)中的相应凹槽(122)并且接触或抓住位于下板(109)上的相应的一个柱(124)。栓钉(120)可以具有表面，其被配置为基本与凹槽(122)的面的间距和/或结构匹配。栓钉(120)中的一个或多于一个可以被装配有基本与相应柱(124)中的一个柱的边缘相匹配的通道，以便更加有效地抓紧下板(109)。此外，插入适配器(106)可以可选地具有其他保持、抓紧或固定装置，例如设置在夹钳(121)上的图示说明的掣子(123)，其可以接合补偿保持、抓紧或固定装置，诸如接收器、凹槽、凹痕等，例如沿着板(108)的相对横向边设置的凹槽(111)。例如，图22A描述凹槽(111)的示例，凹槽(111)使上板(108)能够通过插入适配器(106，在此图中未显示)被保持，例如因为掣子(123)；图22B描述下板(109)的柱(124)(轴、侧柱、立柱或支柱)的示例，其使此板能够被保持并且包括轴肩(12)以用于与插入适配器(106)的栓钉(120)配合，以便当由适配器(106)保持时，维持假体并且避免假体滑落，举例的详细类型稍后参考图18(A-C)。应该明白，当阅读本说明书时，支架和适配器的各种实施例可以被设计成具有或不具有用以保持假体的补偿夹(126)。
各种实施例中的插入适配器(106)还可以包括成角度的接触面(116)，其被配置成与假体板(108，109)的可选成角度边缘补偿接触。可选轴肩(118)可以被配置成与核芯(110)的周边补偿地接触。接触面(116)和轴肩(118)的结合高度可以优选基本等于被组装的假体(104)的板(108，109)之间的距离。从而各种实施例中的接触面(116)和轴肩(118)可以结合从而当假体组装到或安装到或附连到插入适配器(106)时，提供插入适配器(106)的、补偿并且基本适合假体的面。诸如此的成角度结构之间的补偿匹配可以帮助稳定假体(104)并且将其部件均匀地推进椎间盘空间内，在插入期间阻止不想要的假体(104)或其部件的旋转移动或平移移动。
各种实施例可以结合任意或所有上述讨论的结构，但是还可以具有其它附连和支撑机构。例如，一些实施例可以可选地具有其他安装点，诸如在上板(108)、下板(109)或上板和下板内的。其他替换实施例可以具有固定器，诸如销或夹，其适合不同假体部件的一个或多于一个的空穴或凹槽，或许多其他方法中的一种或多于一种方法，从而可以用来在需要时，抓紧目标并且可以方便地释放。
各种实施例中的插入适配器(106)可以具有致动器装置以用于释放椎间盘假体(104)。在各种实施例中，致动器可以被配置为弹簧加载臂、柄脚、杆或其他致动装置(164)，其可绕铰接装置铰接，诸如绕铰链销(172)。可替换地，插入适配器(106)可以具有臂、柄脚、杆或其他致动装置(164)可绕其铰接的整体铰链部分，例如包括弹性材料(诸如塑料或橡胶)或应力/应变释放特征(诸如细缝或空隙)。
在本发明的一些实施例中，插入适配器(106)可以包括一个本体，该本体被分割成至少两个部件(164)，其彼此互补并且组装以便保持至少部分假体(104)在适配器(106)的至少包括栓钉(120)或掣子(123)的一端。在一些实施例中，这些栓钉(120)或掣子(123)可以通过延长适配器本体的每个部件(164)的横向面的分支而形成。术语“栓钉”不应该被限制性地解释，因为装置可以由具有适于在其分支的一端保持假体的分支形成，详细描述如下。优选地，在这些实施例中，适配器(106)将沿着其纵轴线(即假体插入轴线)被分割，以便其本体的两个部件围绕并保持后者的横向面上的假体。因此，在这些实施例中，适配器(106)的致动装置(164)由本体的两个部件组装而成，例如由于销(165a)插入到通道(165e)或孔中，诸如，该孔例如是至少部分穿过插入适配器(106)的本体的每个部件(264)的钻孔。图18(A-C)、19(A和B)、20(A-C)、21(A和B)、23(A-C)和24(A和B)显示多个说明性而不是限制性的可能实施例的示例，图25(A和B)和26(A-D)显示无菌插入工具(131)的实施例的示例，尤其是适于插入适配器(106)的这些实施例的插入工具。在这些实施例中，通过抽出销(165a)并通过拆下形成致动装置(164)的插入适配器(106)本体的两个部件(164)来实现驱动插入适配器(106)从而释放假体(104)，下面将进行详细描述。插入适配器(106)的这些实施例也可以与假体(104)、最终与无菌插入工具(131)被预组装在无菌包中。
图18A显示具体保持假体(104)的插入适配器(106)的实施例，由于适配器的掣子(123)和假体(104)的上板(108)上的凹槽(111)之间的配合，形成将假体(104)锁定在适配器(106)上的机构。在图18(A-C)中所示的示例中，除了在末端装配有用于保持假体的栓钉和掣子外，适配器(106)的本体的两个部件(164)具有基本平行六面体形状。因此，在此示例中，沿着本体纵轴线被分割的本体的两个部件(164)围绕假体被组装并且通过基本平坦的表面配合。适配器(106)的本体的两个部件(164)装配有联接器(140)，其使适配器(106)能够被安装在插入工具(131，例如，图25A和图25B)上。应该注意，可以设计在适配器本体的两个部件中的仅仅一个上仅包括一个联接器的多种不同的实施方式。在所示的示例中，此联接器(140)包括柄，其用以与致动器(136，图25B)配合，诸如，例如杆，其具有螺纹孔(134)用以螺纹接合联接器(140)。应该注意联接器(140)的柄(螺纹杆)和插入工具(131)的致动器(136)的螺纹孔(134，图26B)的结构当然可以被互换或由用于连接(保持、固定)适配器(106)和插入工具(131)的其他装置代替。因此，例如，适配器的联接器可以包括螺纹孔(140)，该螺纹孔(140)与插入工具的致动器(136)的螺纹端(134)配合。在其他实施例中，联接器(140)可以包括位于致动器(136，图25B)一端的杆，该杆具有与包括轴肩的管道配合的平面(165d)。在其他实施例中，联接器(140)可以包括杆，其是螺纹的并且包括平面(165d)，以便适配器(106)和/或销(165a)(在此情况下，其是下面将要详细描述的保持联接器(140)的销(165a))都可以由包括与平面配合的轴肩的工具和由包括螺纹孔的工具操作。此外，可想到，其他实施例被设计成包括具有螺纹孔的联接器，在该联接器底面设置有轴肩，因此该联接器能够与致动器(136，图25B)的螺纹端(134)配合并且能够与包括杆的工具配合，该杆在其一端具有平面。图18B显示此实施例的横截面，该实施例具有邻接适配器(106)的成角度表面或边缘的假体的板(108，109)的成角度边缘(115)。在一些实施例中(未示出)，适配器(106)也可以包括轴肩或表面用以接触核芯(110)以将假体的各个元件(108，109，110)保持在椎骨之间适合插入的位置。具体地如图18C中所示，在此示例中，适配器(106)的本体的两个部件(164)的组装通过在水平面上从一侧到另一侧横向穿过适配器(106)的至少一个销(165a)来完成。在此示例中，销(165a)具有螺纹端(165c)，该螺纹端(165c)能够螺纹连接在转环(或任何其他用以组装的装置)的螺纹孔上。该销(165a)和转环(165b)的螺纹允许将适配器本体的两个部件(164)固定在一起，该适配器固定(保持，围绕)假体的元件，具体是由于栓钉(120)与假体的下板(109)的柱(124)配合并且最终使掣子(或栓钉)(123)与上述提到的凹槽(11)配合。在图18C所示的示例中，适配器(106)本体的两个部件(164)的组装通过从两个部件(164)中的一个突出并且插入另一个部件的孔(167b，图19b)内的杆(167a)来加固。然而，该组装的此加固(167a，167b)不是非常重要，一些实施例中仅包括销(165a)。具体地如图19B中所示，在一些实施例中，销(165a)可以包括与互补形状的外壳(165g)配合的止挡器(165f)，该止挡器(165f)被设置在适配器(106)本体的两个部件(164)中的一个上，以便在螺纹连接转环(165b)期间反抗于销(165a)的旋转。因此，适配器的组装可以通过将销(165a)插入贯通本体的两个部件(164)的孔(165e)内并且通过将转环(165b)的螺纹孔(165c)螺纹连接到销(165a)的螺纹端(165c)上而被简单地完成。应该注意，此处的术语“转环”被用来指定可以螺纹连接在螺纹杆上的元件，不过可以使用任何相似结构，例如图19B中所示的元件和其包括允许使用螺丝刀来螺纹连接的槽。此外，代替转环，直接置于两个部件(164)中的一个上的螺纹孔允许螺纹连接螺纹销(165a)而不需要其他结构。相似的，螺纹结构可以被互换或由其他任何固定销的装置代替。应该注意，在图19B所示的示例中，用来维持板的栓钉(123，120)具有轴肩，该轴肩形成支撑每个板的水平表面，以便维持假体而不需要对板的凹槽(111)和柱(124)施加太大的压力。
在一些实施例中，图20A中描述的示例，适配器(106)本体的两个部件(164)通过曲面配合在一起：一个部件具有包括凸面的部分(169a)，另一个部件具有包括凹面的部分(169b)，该凹面与凸面互补。因此，两个部件(164)中的第一部件形成接纳件(169b)，两个部件(164)中的第二部件形成插入件(169a)，插入件(169a)具有适合插入接纳件(169b)的部分。在图19a所示的示例中，适配器(106)是至少部分由管道(或通道)(165e)通过，诸如，例如在本体的两个部件的插入件(169a)和接纳件(169b)的水平面上形成的钻孔。因此，插入到这个管道(165e)中的销(165a)能够使适配器本体的两个部件(164)组装和维持在一起。在这些实施例中，管道(165e)和销(165a)沿着适配器(106)的纵轴线定向。具体地如图20B和图20C所示，销(165a)的至少一部分上的螺纹(165c)可以与管道(165e)中的螺纹配合。在此示例中，销还包括止挡器，例如，诸如轴环或套筒(143)用以限制螺纹连接的销。在一些实施例中，诸如图20A到图20C所示，本体的两个部件(164)的插入部分(169a)和接纳部分(169b)被设置成在至少与保持假体的端部相对的端部处、在两个部件之间保留空间(169c)。当销(165a)从管道(165e)中抽回时，由于其相应曲面间的互补，在与保持假体的端部相对的端部的水平面上，此空间能够使施加在两个部件(164)的横向表面上的压力导致两个部件中的一个相对另一个旋转，并且该空间能够以与夹子相似的方式释放假体。此外，管道(106e)可以包括放大的部分(16)，以便便于插入和抽回销。如图20(A-C)所示，销(165a)可以包括用于插入工具(131)的联接器(140)。在此示例中所示，联接器(140)包括平面(165d)以便用于配合包括互补轴肩的孔，即致动器(136，图25B)的一端。当然可以设计出其他结构的联接器(140)。例如，具体地如图21A所示，联接器(140)可以由螺柱或在至少部分上包括螺纹(135)的杆组成，销(165a)可以包括螺纹(165c)，该螺纹连接在适配器上的螺纹(165c)由止挡器(143)(诸如轴环)限制。在具体地有利的变化中，销(165a)的螺纹(165c)的螺距和联接器(140)的螺纹(135)的螺距可以被互换，以便当工具停止在轴环(143)上时，使得插入工具螺纹连接在联接器(140)上能够使非螺纹连接的销(165a)在不需要外科医生的情况下改变螺钉方向。图21B显示适配器本体的部件(164)的细节，具体地，显示用来保持假体(104)的下板(109)的栓钉(120)上的轴肩(120bis)。该轴肩被设置成有效地维持下板(109)的柱(124)，其也可以包括互补轴肩(12)，具体地如图22B所示。相似地，图21B显示包括轴肩或支撑表面的栓钉(123)，该栓钉用来维持上板(108)。
图23A、图23B和图23C显示被分割成两个互补部件(164)的插入适配器(106)的另一个实施例。在此类型的实施例中，部件中的第一部件包括至少一个插入部分(169a)，部件中的第二部件包括至少一个接纳部分(169b)，该接纳部分(169b)与第一部件的插入部分互补。在所示的示例中，具有基本方形截面或矩形截面的两个插入部分与具有互补形状的两个接纳部分配合。当领会公开的此实施例和上一个实施例时，应该理解，本发明允许插入部分和接纳部分的多个实施例并且其数目可以改变。图24A和图24通过分别比较这些实施例的组装视图和拆卸视图显示了组装和拆卸的插入适配器(106)。在此示例中，通过将本体的两个部件(164)联合在一起并且将销(165a)插入到管道(165e)中，可以完成该组装。类似地，通过抽回销并且将两个部件(164)分开可以完成该拆卸。
本领域的技术人员在领会本发明后，将意识到可以为插入适配器(106)设计许多其他结构配置用以抓住椎间盘假体(104)和当椎间盘假体被插入到椎间盘空间时，释放椎间盘假体(104)。此外，此处说明的各种实施例和示例可以合并在一起，除非此处另有说明或其不兼容。
假体插入组件(100)的一些实施例可选地可以具有夹子(126)，其可以环绕被组装的假体(104)并且将板(108，109)保持在核芯(110)上。在运输期间和/或将插入适配器(106)安装、附连或组装到插入工具本体(130)或将插入适配器(106)安装、附连或组装与插入工具本体(130)期间，阻挡装置，诸如夹子(126)，帮助(augment)插入适配器(106)维持被组装的假体(104)。可选地，夹子(126)可以具有一个或多于一个的用于移除的装置(移除装置)，以便当假体插入组件(100)被组装、被安装或附连到插入工具本体(130)时有助于移除夹子。这些用于移除的装置可以是诸如夹子(126)的上表面和下表面(分别)上的突舌(127，128)(tabs)，在下面将进一步讨论。
在一些优选实施例中，椎间盘假体(104)和插入适配器(106)的部件可以使用伽玛射线被消毒。消毒后，部件可以被包装在初级无菌包装(103a)内以形成无菌包(102)，尽管包装拆卸的椎间盘假体(104)和插入适配器(106)的部件在本发明范围内，但是优选包装组装为插入组件(100)的椎间盘假体(104)和插入适配器(106)的部件。在各种优选实施例中，被包装在初级无菌包装(103a)内的椎间盘假体(104)和插入适配器(106)的部件，无论是组装的还是拆卸的，其可以进一步被包装在盒子或其他容器内并且被封闭在二级无菌包装(103b)内以形成无菌包(102)。无菌包装(103a，103b)可以包括泡沫包装、泡罩包装、收缩包装或其他已知的适于保持无菌医疗植入的包装结构。在一些实施例中，无菌包装(103a，103b)可以优选具有吸氧包，例如用来减少潜在的聚乙烯核芯(110)或其他部件的氧化降解。在优选实施例中，无菌包(102)可以优选被制成易于直接或通过分配器输送或运输到手术室的无菌区。
插入装置(100)的无菌包(102)优选具有标识信息。例如，各种实施例可选地具有带有标识信息(180)的包装标签(198)。标识信息可以包括插入装置(100)或其部件的保质期(use-before-date)、批号和参考号或序列号、无菌控制标签以及/或者板(108，109)和核芯(110)的尺寸和结构信息。优选地，包装标签允许通过在具体病人中的最后植入和服务从初始制造完全追溯到插入组件(100)。在一些实施例中，无菌包(102，202)可以包括至少一个透明壁(107)，该透明壁(107)使得能够从包(102，202)外面看到插入组件(100，101，105)。
此处描述的各种实施例为医护人员提供分类或其他库存的预消毒的、预配置的及预组装的插入组件(100)。可选地，包装的椎间盘假体插入组件可以装备有被拆卸的椎间盘假体(104)及预配置的插入适配器(106)，在其组装后，该预配置的插入适配器(106)可以用于椎间盘假体(104)。在此类实施例中，椎间盘假体(104)的部件一般将插入适配器(106)组装在无菌区内以形成插入组件(100)。
在各种实施例的手术过程期间，外科医生确定合适尺寸和结构的假体(104)。例如，椎间盘空间的测量可以用在此确定中。优选地，手术队可以在手术室无菌区从假体插入组件(100)的库存中获得合适的假体插入组件(100)。
在各种公开的实施例中，诸如图4中所示，无论提供组装的椎间盘假体(104)还是拆卸的椎间盘假体(104)，假体插入组件(100)均可以被配置成用于可拆卸的或可拆除的工具本体(130)，该工具本体(130)在手术过程期间可以用来将假体(104)植入到椎间盘空间。假体插入组件(100)和插入工具本体(130)可以优选地被设置或组装成，例如通过将假体插入组件(100)附连或安装到插入工具本体(130)上，而在手术室的无菌区内使用。
在从无菌包(102)拆除后，插入组件(100)和可拆卸或可拆除的插入工具本体(130)被组装。对于图5A和图5B 中所示的实施例，假体插入组件(100)可以支撑件(132)并排，诸如例如所图示说明的外壳，该支撑件(132)被设置成在植入过程期间接收和支撑假体插入组件(100)。优选地，插入工具本体(130)可以适于用于全部的可得到的各种尺寸和结构的椎间盘假体(104)或至少许多种类的可得到的各种尺寸和结构的椎间盘假体(104)。在椎间盘假体输送和插入系统的一些实施例中，各种假体(104)的高度可以差别很大。支撑件(132)可选地可以被装配有一个或多于一个固定器，例如图示说明的凸榫(133)，以将假体部件固定于组件中。配置此类固定器的其他实施例可以使用诸如夹子、掣子、弹簧或其他偏压部件的结构。诸如凸榫(133)的固定器可以帮助使各种尺寸和结构的假体相对于支撑件(132)居中并且支撑各种尺寸和结构的假体。
在领会本发明后，本领域的技术人员将易于意识到安装、连接、组装、附连或其他接合假体插入组件(100)和插入工具本体(130)的多种可替换装置。例如，插入工具本体(130)可以装备有致动器(136)，诸如杆、轴、线缆或其他传输或控制结构，例如图6A、图6B和图6C中说图示说明的。各种实施例中的致动器(136)可以具有接合装置，例如图示说明的杆(136)的螺纹端(134)，以接合或连接插入适配器(106)的联接器(140)，例如图3中所示的螺纹孔。一旦接合，在移植过程期间，杆(136)可以保持并且推动插入适配器(106)。
假体插入组件(100)可选地可以通过使得螺纹端(134)和螺纹孔(140)接合而被附连或安装到插入工具本体(130)。插入组件(100)可以通过手动地至少部分地被设置在支撑件(132)内，至少达到插入组件(100)接合螺纹端(134)位置的点。插入组件(100)可以进一步通过手动地被完全设置在支撑件(132)内，使螺纹端(100)凹进插入工具本体(130)的构件(138)内。在这一点上，螺纹端(134)可以在螺纹孔内旋转直到完成与螺纹的适当接合并且假体插入组件(100)被牢固地固定在支撑件(132)内。可选地，当与螺纹孔(140)初始接合时，螺纹端(134)可以在螺纹孔(140)内旋转直到假体插入组件(100)被完全拖进支撑件(132)内并且固定在支撑件(132)内。不考虑假体插入组件(100)是如何被设置在支撑件(132)内的，夹子(126)的相应上表面和下表面(分别)上的突舌(127，128)可以被配置成，在插入组件(100)位于插入组件(100)之前，分别接触支撑件(132)的前缘(152)，导致当插入组件(100)被进一步移入支撑件(132)内时夹子(126)从假体(104)拆除，例如如图5中所示。
图25A显示维持插入适配器(106)的插入工具(131)的一些实施例的示例的透视图，该插入适配器(106)的本体被分割成两个部件(164)，例如诸如图18-24中的一个所示，围绕(保持)假体(104)。由假体(104)形成的组件根据本发明的一些实施例可以形成插入组件，其中假体(104)由适配器(106)保持，适配器(106)由插入工具(131)保持。对应于图25和图26的插入工具(131)的实施例(其尤其适于图18-24的适配器(106)的实施例)中，致动装置(136)可以包括一个或多个杆，该一个或多个杆的一端包括联接器(134)(诸如例如螺纹孔)，该联接器(134)与适配器的联接器(140)(诸如此示例中的至少一个螺纹杆)配合以保持假体，该一个或多个杆的另一端由外科医生操控，例如由于诸如旋钮的控制装置(142)从而能够使致动装置(136)螺纹连接在适配器的联接器上。在所示的实施例中，一个(或多个)致动装置(136)被设置在插入工具本体(130)内，该插入工具包括可以被操控的构件(138)，诸如致动器(136)可以在其上自由旋转和平移的电枢或刚性壳，从而驱动旋钮(142)会允许将适配器(106)固定在插入工具(131)上(相互地)。插入工具(131)还包括支撑件(132)，该支撑件(132)包括外壳和边缘(152)，该外壳的形状和尺寸被设置成接收插入适配器(106)，该边缘(152)形成止挡器，该止挡器被放置为接触至少一块椎骨。应该注意，在这些实施例中，工具的支撑件(132)并非是不可或缺的，并且边缘(152)有用于指示假体相对椎骨边缘的位置。因此，在一些实施例中，支撑件(132)可以是不围绕适配器的类型或甚至可以不存在，然后插入工具(131)最终包括延长了构件(138)的止挡器，从而形成边缘(152)，该边缘(152)用来接触椎骨的边缘。如图25B所示，在一些实施例中，插入工具(131)的支撑件(132)在其至少一个横向表面上包括至少一个凹槽(110)，其留出了自由进入插入适配器(106)的至少横向表面的通路。因此，具体地如图26B所示，这些凹槽(110)能够使得诸如例如图18A所示类型的适配器(106)的销(165a)和/或转环(165b)通过，以便一旦适配器被插入工具维持并且在假体(104)插入椎骨之间之前，销可以被抽回。因此，一旦假体被插入椎骨之间，当插入工具(131)从适配器断开，适配器(106)可以容易地被拆卸，同时在此阶段非螺纹连接的销是令人生厌的。在其他实施例中，这些凹槽是不必要的，因为销(165a)沿着适配器(106)的纵轴线定向，并且可以在假体(104)插入到椎骨之间之后被抽回。例如，在具有销(165a)的实施例中，该销(165a)通过相对于致动装置(136)所螺纹连接的螺纹(135)逆反的螺纹(165c)而螺纹连接在适配器器(106)内，螺纹连接致动装置通过适配器而抽回销并且便于释放假体。在一些实施例中，插入工具(131)还包括安装在致动器(136)的一端上的盖(199)，该致动器(136)包括控制装置(142)(或旋钮)，以便使外科医生能够推动组件(105)并且最终抓住它(例如通过工具)以将假体插入到椎骨之间。如图26C和图26D所示，该盖(199)可以包括球或螺丝钉(151)，该球或螺丝钉(151)能够使其固定在致动器(136)的一端上。在后面将解释其他实施例，在与图25和图26所示的实施例相似的实施例中，插入工具(131)可以包括：至少一个可调止挡器(144)用以控制假体(104)在椎间盘空间内的插入；和/或刻度尺用以指示假体(104)和/或适配器(106)相对于插入工具(131)和/或椎骨的位置，例如由于止挡器(152)。
如图6A、图6B和图6C中所示，对于一些实施例，致动器(136)可以通过构件(138)，例如其可以被配置为图示所明的框架或轴。致动器(136)可以在与支撑件(132)相对的插入工具本体(130)的一端上装配有控制器，诸如旋钮(142)或杠杆、按钮或其他控制结构。在各种实施例中，控制器(142)可以控制插入适配器(106)和假体(104)从支撑件(132)输送到椎间盘空间以及在此输送后从插入工具本体(130)释放插入适配器(106)，但是可以为每个功能提供单独控制，并且可选地可以为其他功能提供单独控制。对于各种实施例中的假体(104)的插入，杆(136)可以朝向支撑件(132)(插入方向)在插入工具本体(130)的构件(138)内滑动，因此将插入组件(100)移入到椎间盘空间内。随着插入组件(100)被移入到椎间盘空间内，杆(136)的螺纹端(134)可以从插入适配器(106)的联接器上分离并且插入工具本体(130)被移离。
插入工具本体(130)的各种实施例可以优选被配置有可调的插入止挡器以控制椎间盘假体(104)在椎间盘空间内的插入距离。图6A、图6B和图6C描述一种示例性的可调止挡器结构。在图6A中，假体插入组件(100)被完全设置在支撑件(132)内并且由支撑件(132)牢固地固定，且该支撑件(132)具有与螺纹孔(140)基本或完全接合的螺纹端(134)。刻度尺(147)可以被设置在平面凹槽上，该平面凹槽被设置在与控制旋钮(142)一体成形或附连在控制旋钮(142)上的轴或螺柱(141)上。刻度尺(147)可以被标刻成合适的长度单位并且可以包括零刻度(148)。插入适配器(106)的柄脚(164)和螺纹孔(140)可以被成尺寸和配置成容纳螺纹孔(140)内的螺纹端(134)在图6A所示的位置进一步旋转。旋钮(142)可以以手柄(139)调整以将零刻度(148)设置在合适的指示位上，诸如手柄(139)的末端或其他形式的参照物，例如如图6B中图示说明的，其指出在支撑件(132)的完全安装位置上的旋钮(142)、轴或螺柱(141)、杆(136)和假体插入组件(100)。
对于各种实施例，当零刻度(148)被设置在如下指示位上，即假体插入组件(100)位于支撑件(132)的完全安装位置上时，例如如图6B中所描述的，则刻度尺(147)将指出由于杆(136)在插入工具本体(130)的构件(138)内的运动而导致的假体插入组件(100)从支撑件(132)延伸出的距离。在插入椎间盘假体(104)期间，支撑件(132)的前缘(152)可以被牢固地保持在各自的椎骨(150)上，该椎骨(150)限定接收假体(104)的椎间盘空间，例如如图8和图10中所示。此外，刻度尺(147)可以用来指示假体(104)插入到椎间盘空间内的距离。
各种实施例可以使用可调止挡器，例如沿着轴或螺柱(141)的螺纹(137)可调的螺纹螺母(144)。可调止挡器(144)可以用来控制假体(104)插入到椎间盘空间内的距离。例如，在各种实施例中，当可调止挡器(144)邻接手柄(139)的末端时，沿插入方向滑动的杆(136)将被停止。止挡锁可以用来维持止挡器(144)的设定，例如通过使用图示说明的锁紧螺母(146)，或通过其他已知的锁定结构。优选地，止挡器(144)根据椎间盘空间的尺寸是可调整的，一般在本发明的其他地方所讨论的手术过程的插入阶段之前测量分析该尺寸。图6C描述通过邻接手柄(139)的止挡器(144)所控制的从支撑件(132)伸出一定距离的插入组件(100)。
图7图示说明手术过程实施例的插入阶段开始。插入工具(130)和假体插入组件(100)可以根据上述讨论被配置和调整。插入工具(130)和插入组件(100)可以位于理想的假体插入轴线上并且位于使支撑件(132)的前缘(152)接触各自的椎骨(150)的位置，其中所述椎骨(150)限定接收假体(104)的椎间盘空间。在各种实施例中，外科医生可以通过使用软锤或用手按压或打击旋钮而向旋钮(142)施加压力。如图8所示，直到止挡器(144)邻接手柄(139)的末端，才停止施加压力。当止挡器(144)邻接手柄(139)的末端时，杆(136)的末端(134)将插入适配器(106)推进到假体(104)适当地位于椎骨(150)之间的椎间盘空间的位置处。图9和图10提供了此阶段的最后位置的代表性说明。
对于不同实施例，通过逆时针旋转旋钮(142)直到螺纹端(134)从螺纹孔(140)释放，插入工具本体(130)可以从插入组件(100)拆除或拆卸。图11显示当插入工具本体正在被抽回时的插入工具本体(130)，仅将插入组件(100)留在椎骨(150)之间的开口内。例如如图12所示，拆卸工具(160)可以用来将插入适配器(106)从假体104上分离，且将假体(104)留在处于被移植到椎间盘空间内的状态。图13显示接近插入适配器(106)的拆卸工具(160)。拆卸工具(160)的工具端(162)可以沿着插入适配器(106)的柄脚(164)以下面方式设置：销(166)进入设置在柄脚(164)内的槽(168)。其他实施例可以包括位于每个柄脚(164)中的一个单个孔、多个更小的孔或槽、或许多用于拆卸工具(160)的其他装置中的任何一个，以便附连、连接或抓住插入适配器(106)的柄脚(164)。通过挤压拆卸工具(160)的手柄(170)来驱动拆卸工具(160)可以使得插入适配器(106)的柄脚(164)围绕铰链销(172)枢转，使夹钳(121)释放板并且安装栓钉(120)以释放其抓紧的柱(124)和从凹槽(122)脱离。在插入适配器(106)的可替换实施例中，插入适配器(106)包括柄脚(164)铰接于其上的弹性部分，在该实施例中挤压柄脚(164)将使弹性本体弯曲、柄脚(164)铰接、夹钳(121)释放板并且安装栓钉(120)释放其抓紧的柱(124)并从凹槽(122)脱离。一旦插入适配器(106)释放假体(104)，则插入适配器(106)可以被移除，例如如图14所示，且将假体(104)留在两块椎骨(150)之间的椎间盘空间中的合适位置。
还可以提供椎间盘假体输送和插入系统的各种实施例。在优选的实施例中，无菌包(102)库存可以被维持在专用的库存存储空间内，例如图15所示的货架(190)。各种实施例可以具有假体，其中每一个假体均具有第一板、第二板和核芯，其中第一板具有从第一尺寸和结构规格组中选择的尺寸和结构，第二板具有从第二尺寸和结构规格组中选择的尺寸和结构，核芯具有从第三尺寸和结构规格组中选择的尺寸和结构。第一板、第二板和/或核芯结构可选地可以特定用以脊柱前凸或脊柱后凸矫正。在各种实施例中，尺寸和结构规格组中的任何一个可以仅包含一个元件，在此情况下，具体的部件可以仅被提供一种尺寸和结构。
优选地，通过板尺寸、核芯高度以及脊柱前凸/脊柱后凸矫正角(若有的话)可以管理库存，不过假体(104)的其他特征可以用于管理方案。例如，每个货架(190)可以包含各种尺寸的插入组件(100)，每种尺寸都具有一个具体的脊柱前凸/脊柱后凸矫正角，且其通过包装假体(104)的板尺寸成排地在各自货架(190)上管理无菌包(102)，通过包装假体(104)的核芯高度成列地在各自货架(190)上管理无菌包(102)。可选地，使用第一尺寸和结构规格组、第二尺寸和结构规格组和/或第三尺寸和结构规格组的任何组合的任意管理方案都可以被使用。优选地，每个存储位置(194)对应于一个所选的第一尺寸和结构规格、第二尺寸和结构规格和/或第三尺寸和结构规格的组合。
如上所述，在各种实施例中，插入组件(100)的无菌包(102)优选具有标识信息。例如，各种实施例可选地具有带有标识信息(180)的包装标签(198，图16)。设置在无菌包(102)上的标签(180)优选指示被封装的假体的板尺寸、核芯高度和脊柱前凸/脊柱后凸矫正角(若有的话)，以及指示出指定的无菌包(102)的库存单位(SKU)和上述讨论的其他信息，所有这些信息或一些这些信息优选可以被编码成可扫描的编码，该可扫描的编码被包括在包装的标签或其他部件上，例如芯片或应答器上。其他信息(180)可以可选地被提供，例如另外的后勤管理信息，诸如检验数据、记录点、生产周期等，或与手术技术和设备相关的信息。编码可以用条形码或光码、磁条、射频识别或其他已知的技术实现。当插入组件(100)被存在货架上时，无菌包(102)上的标识信息(180)优选是可读的。
无菌包(102)存储位置，例如货架(190)的箱柜(194)，对于被存储在箱柜(194)内的无菌包(102)，可选地，每个可以包含具有标识信息的标签，例如如图19中所描述的。当然，可以使用提供与被存储在箱柜(194)内的无菌包(102)相关的信息的其他装置，例如磁条、射频识别或其他已知技术。优选地，当各个箱柜(194)是空的时，每个箱柜标签(194)或其他形式的标识信息可以是可读的。因此，通过提供用以根据定期观测的空货架空间重新排列的足够信息可以简化库存，并且通过货架的管理方案可以简化外科手术期间矫正组件(100)的获得。库存和插入组件(100)的获得可以进一步通过在手术室的无菌区内提供标签或其它信息扫描设备被进一步加强，其将提供另一层次的无菌包(102)排列和获得的检验。
在领会本发明后，本领域的技术人员将意识到其他有利的后勤管理技术可以被用于此处公开的椎间盘假体输送和插入系统和方法。
上面描述了包括一个无菌插入适配器(106)和n个椎间盘假体(104)的无菌部件的被包装的椎间盘假体插入组件(101)的实施例的各个特征。在领会本发明后，本领域的技术人员将意识到相似的特征可以被提供在包括一个无菌插入工具(131)和一个椎间盘假体(104)的无菌部件的被包装的椎间盘假体插入组件(105)的实施例中。例如，如图17所示，无菌插入工具(131)和无菌椎间盘假体(104)可以被组装在一起并且被设置在初级或内部无菌包装(103a)内以及二级或外部无菌包装(103b)内以形成无菌包(202)。在此实施例中，椎间盘假体(104)的部件可以与无菌插入工具(131)组装并且被提供到预先配置的手术室的无菌区以准备使用。无菌插入工具(131)可选地可以具有插入工具本体(130)和可拆卸的插入适配器(106)，其可以被包装、组装或拆卸。可替换地，无菌插入工具(131)可以具有与插入工具本体(130)一体成形的插入适配器(106)，或无菌插入工具(131)可以具有其他结构，该其他结构被设计为保持椎间盘假体(104)和/或将椎间盘假体(104)输送到椎间盘空间。上述讨论的插入适配器(106)和/或插入工具本体(130)的各个特征，和/或前面的各种部件和上述讨论的其他部件，可选地可以被包括用于被包装的椎间盘假体插入组件(105)。上述讨论的椎间盘假体输送和插入系统的各个特征，以及其他系统的特征，可选地也可以与包括一个无菌插入工具(131)和一个椎间盘假体(104)的无菌部件的被包装的椎间盘假体插入组件(105)一起使用。
在领会本发明之后，本领域的技术人员将意识到各种方法、过程的步骤和此处公开的其他技术不需要以任何具体顺序执行，除非另有说明或逻辑需要以满足所述的先行条件。此外，在领会本发明后，本领域的技术人员将意识到本发明可以被以多个不同形式实施，并且在不偏离本发明的思想和范围的情况下，可以进行各种变化、代替和替换。所述的实施例仅仅是说明性的而非限制性的，并且本发明的范围仅有所附权利要求限定。

Claims (15)

1.一种椎间盘假体插入组件，其包括插入适配器(106)和椎间盘假体(104)，所述插入适配器(106)具有用于可拆卸的插入工具本体(130)的联接器(140)，所述椎间盘假体(104)通过所述插入适配器(106)被可释放地保持，所述椎间盘假体插入组件的特征在于：所述插入适配器(106)被分成至少两个部件(164)，所述至少两个部件(164)围绕所述假体的至少一部分被可释放地固定，所述插入适配器(106)的所述两个部件(164)形成用于释放所述假体(104)的致动装置。
2.根据权利要求1所述的椎间盘假体插入组件，其特征在于：围绕所述假体的至少一部分被可释放地固定的所述两个部件(164)被设置成通过使一个相对于另一个枢转来释放所述椎间盘假体(104)。
3.根据权利要求1所述的椎间盘假体插入组件，其特征在于：所述插入适配器(106)和所述椎间盘假体(104)被设置在无菌包装(103a，103b)内以形成无菌包(102，202)。
4.根据权利要求1所述的椎间盘假体插入组件，其特征在于：所述插入适配器(106)具有一个表面(116)，所述表面(116)与所述椎间盘假体(104)互补并且基本适合所述椎间盘假体(104)。
5.根据权利要求1所述的椎间盘假体插入组件，其特征在于：所述插入适配器(106)具有至少一个固定器，所述至少一个固定器接合所述椎间盘假体(104)的凹槽(111，122)和/或柱(124)。
6.根据权利要求5所述的椎间盘假体插入组件，其特征在于：所述固定器是掣子(123)，并且所述凹槽(111)被设置在所述椎间盘假体(104)的板(108，109)的边缘(112)上。
7.根据权利要求5和6中的任一项权利要求所述的椎间盘假体插入组件，其特征在于：所述固定器是栓钉(120)，并且所述凹槽(122)沿着所述椎间盘假体(104)的核芯(110)设置。
8.根据权利要求7所述的椎间盘假体插入组件，其特征在于：所述栓钉(120)具有通道，所述通道基本与所述椎间盘假体(104)的板(108，109)的柱(124)的边缘(112)匹配。
9.根据权利要求1所述的椎间盘假体插入组件，其特征在于：其包括插入工具(131)。
10.根据权利要求9所述的椎间盘假体插入组件，其特征在于：所述插入工具(131)包括可释放地安装在所述联接器(140)上的可拆除的插入工具本体(130)。
11.根据权利要求10所述的椎间盘假体插入组件，其特征在于：所述插入工具本体(130)包括插入致动器(136)。
12.根据权利要求10和11中的任一项权利要求所述的椎间盘假体插入组件，其特征在于：所述插入工具本体(130)包括插入止挡器(144)。
13.根据权利要求10所述的椎间盘假体插入组件，其特征在于：所述插入工具本体(130)包括插入止挡锁(146)。
14.根据权利要求13所述的椎间盘假体插入组件，其特征在于：所述插入止挡锁(146)是可调整的。
15.根据权利要求1所述的椎间盘假体插入组件，其特征在于：所述椎间盘假体包括第一板(108)、第二板(109)和核芯(110)。
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AU2008215916A1 (en) 2008-08-21
BRPI0808134A2 (pt) 2014-06-17
RU2009130810A (ru) 2011-03-27
US10188528B2 (en) 2019-01-29
CA2677598C (en) 2015-01-13
KR20090110361A (ko) 2009-10-21
CA2677598A1 (en) 2008-08-21

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