CN104936555B - 可扩张的脊柱植入物系统和方法 - Google Patents
可扩张的脊柱植入物系统和方法 Download PDFInfo
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- CN104936555B CN104936555B CN201380070493.XA CN201380070493A CN104936555B CN 104936555 B CN104936555 B CN 104936555B CN 201380070493 A CN201380070493 A CN 201380070493A CN 104936555 B CN104936555 B CN 104936555B
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- component
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Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
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Abstract
脊柱植入物包括第一构件,其具有限定轴向腔体的壁。第二构件在第一端部和第二端部之间延伸并且限定纵向轴线。第二构件构造成用于与轴向腔体设置在一起并且相对于第一构件平移。第三构件具有能够与组织接合的外表面和内表面,该内表面设置成响应于外表面与组织的接合而动态地接合第一端部。公开了系统和方法。
Description
技术领域
本公开整体涉及用于治疗肌肉骨骼疾病的医疗装置,并且更特别地涉及一种包括可扩张脊柱植入物的外科系统和用于治疗脊柱的方法。
背景技术
诸如脊柱侧凸及其它曲度异常、驼背、退行性椎间盘疾病、椎间盘突出、骨质疏松、脊椎前移、狭窄、肿瘤和骨折的脊柱疾病可源自由损伤和老化造成的包括创伤、疾病以及退行性病症的因素。脊柱疾病通常导致包括疼痛、神经损伤和可动性的部分或完全丧失的症状。
诸如药物、康复训练和锻炼的非外科手术治疗可能是有效的,但是可能不会解除与这些疾病相关的症状。这些脊柱疾病的外科手术治疗包括融合术、固定、椎体次全切除术、椎间盘切除术、椎板切除术和可植入的假体。在诸如椎体次全切除术和椎间盘切除术的手术中,可以进行采用植入物来恢复椎骨的机械支撑功能的融合和固定治疗。本公开描述了对这些现有技术的改进。
发明内容
在一个实施例中,根据本公开的原理,提供了一种脊柱植入物。脊柱植入物包括第一构件,其具有限定轴向腔体的壁。第二构件在第一端部和第二端部之间延伸并且限定纵向轴线。第二构件构造成用于与轴向腔体设置在一起并且相对于第一构件平移。第三构件具有能够与组织接合的外表面和内表面,该内表面设置成响应于外表面与组织的接合而动态地接合第一端部。
附图说明
根据具体描述并结合以下附图,本公开将变得更为显而易见,在附图中:
图1是根据本公开的原理的外科系统的部件的一个实施例的透视图;
图2是图1所示系统的部件的透视图;
图3是图1所示系统的部件的透视图;
图4是图1所示系统的部件的剖开透视图;
图5是与椎骨设置在一起的图1所示系统的部件的透视图;
图6是与椎骨设置在一起的图1所示系统的部件的透视图;
图7是根据本公开的原理的外科系统的部件的一个实施例的透视图;
图8是图7所示系统的部件的透视图;
图9是图7所示系统的部件的剖开视图;以及
图10是根据本公开的原理的外科系统的部件的一个实施例的透视图。
具体实施方式
所公开的外科系统及相关使用方法的示例性实施例将结合用于治疗肌肉骨骼疾病的医疗装置进行讨论,更特别地,将结合包括可扩张的脊柱植入物的外科系统和用于治疗脊柱的方法进行讨论。
在一个实施例中,外科系统包括具有至少一个铰接端盖的植入物,所述至少一个铰接端盖调整以匹配该植入物接合的椎骨终板的角度。在一个实施例中,终板接合植入物,使得终板的相对取向选择性地确定端盖的取向(例如,所需角度)以与终板接合。该构型在端盖和椎骨之间提供接合,以有利于将椎骨的压缩负载分布在植入物上。在一个实施例中,铰接端盖适应身体的矢状面和/或冠状面中的轴向偏移,并且允许端盖恰当地座置在终板中。在一些实施例中,该构型抵抗和/或防止在端盖的角度与颅侧和尾侧的椎骨终板之间的角度之间的失配。在一些实施例中,该构型抵抗和/或防止在植入物上的点负载和最终的沉陷。
在一个实施例中,外科系统包括植入物,其具有铰接端盖以用于可扩张的椎体置换植入物。在一个实施例中,端盖包括婚礼蛋糕构型。在一个实施例中,婚礼蛋糕具有在植入物的顶部和穹顶形端盖上的阶梯式外形。在一个实施例中,端盖包括锁环,其允许端盖选择性地和/或自动地安放在婚礼蛋糕阶梯中的一个或多个上,以适应相邻椎体。在一个实施例中,穹顶形端盖是可变形的,以用于与植入物的阶梯式外形接合,从而在椎骨终板之间提供植入物的锁定接合。例如,在由于例如脊柱的撑开力或自然的轴向负载导致的轴向压缩力下,阶梯式的婚礼蛋糕外形使穹顶形端盖变形和/或凹陷以将植入物锁定在最终构型。
在一个实施例中,端盖包括销和定位螺钉构型,其有利于两个不同的自由度,以允许端盖相对于植入物端部的关节运动。在一个实施例中,植入物包括第一自由度,其包括围绕由销和定位螺钉限定的轴线枢转。在一个实施例中,植入物包括第二自由度,其包括销和定位螺钉设定成诸如圆形、矩形或正方形的几何构型以及在植入物的外侧壁中的穹顶形凹陷或松配合以允许关节运动。在一个实施例中,关节运动可由穹顶形凹陷的尺寸限制。在一些实施例中,销和/或定位螺钉顶端可具有各种构型,例如,互补于对应于侧壁的凹陷的穹顶形弯曲,或者构造用于在侧壁的凹陷处的单点负载的倒圆顶端。在一个实施例中,定位螺钉构造成简化端盖在植入物的内芯上的组装并有利于定位螺钉的最终紧固以将端盖锁定在最终构型。
在一个实施例中,外科系统的部件中的一个或所有是与植入物一起使用的一次性的、金属箔消毒密封包装(peel-pack)的预包装无菌装置。外科系统的部件中的一个或所有可重复使用。外科系统可构造成具有多个定尺寸且经构造的部件的成套器械。
在一些实施例中,本公开用来治疗脊柱疾病,例如退行性椎间盘疾病、椎间盘突出、骨质疏松、脊椎前移、狭窄、脊柱侧凸和其它曲度异常、驼背、肿瘤及骨折。在一些实施例中,本公开可用于其它骨应用和骨相关应用,包括与诊断和治疗相关联的那些。在一些实施例中,所公开的外科系统和方法可替代地用于处于俯卧位或仰卧位的患者的外科手术治疗中,和/或采用包括前面、后面、后面中线、外侧、后外侧、和/或前外侧入路以及在其它的身体区域中的各种至脊柱的手术入路。本公开还可以替代地与用于治疗脊柱的腰椎、颈椎、胸椎、骶椎和骨盆区域的手术一起使用。本公开的系统和方法还可诸如在培训、测试和示范中用于动物、骨模型和其它无生命基质。
参照各实施例的以下详细描述并结合形成本公开的一部分的附图,可以更容易理解本公开。应当理解,本申请并不限于本文所述和/或所示的具体装置、方法、条件或参数,并且本文所用术语的目的仅在于以举例的方式描述特定实施例,而并非旨在进行限制。而且,如包括所附权利要求的说明书中所用,单数形式“一种”、“一个”和“该”包括复数,并且提及的具体特定数值至少包括该特定值,除非上下文另外清楚地指明。在本文中,范围可表示为从“约”或“大约”一个特定值和/或到“约”或“大约”另一个特定值。当表示这样的范围时,另一个实施例包括从一个特定值和/或至另一个特定值。类似地,当通过使用先行词“约”将值表示为近似值时,应当理解该特定值形成另一个实施例。还应当理解,所有空间参考,例如“水平”、“竖直”、“顶部”、“上部”、“下部”、“底部”、“左侧”和“右侧”仅为了进行示意性的说明,并且可以在本公开的范围内变化。例如,参考“上部”和“下部”是相对的并且仅在另一个的上下文中使用,并且不一定是“上方”和“下方”。
此外,如包括所附权利要求的说明书中所用,“治疗”疾病或病状是指执行程序,其可包括将一种或多种药物施用给患者(正常的或不正常的人或其他哺乳动物),采用可植入的装置,和/或采用治疗疾病的器械,例如用来移除鼓起部分或突出的椎间盘和/或骨刺的微创椎间盘切除术器械,以努力减轻疾病或病状的体征或症状。减轻可发生在疾病或病状的体征或症状出现之前以及它们出现之后。因此,“治疗”包括“预防”疾病或不期望的病症(例如,预防疾病在患者体内发生,该患者可能易患该疾病但在患病时还未被诊断出)。此外,“治疗”不需要完全减轻体征或症状,不需要治愈,并且具体地包括对患者仅具有少量效果的手术。治疗可包括抑制疾病(例如阻止其发展)或解除疾病(例如引起疾病的消退)。例如,治疗可包括:减少急性或慢性炎症;减轻疼痛并减缓和诱导新韧带、骨和其它组织的再生;作为手术中的辅助;和/或任何修复手术。另外,如包括所附权利要求的说明书中所用,术语“组织”包括软组织、韧带、肌腱、软骨和/或骨,除非另外具体指明。
以下的讨论包括对外科系统以及采用根据本公开的原理的外科系统的相关方法的描述。另外公开了备选实施例。现在将详细参考附图中示出的本公开的示例性实施例。现在转到图1至图6,示出了根据本公开的原理的诸如脊柱植入物系统10的外科系统的部件。
脊柱植入物系统10的部件由适合医学应用的生物可接受材料制造,包括金属、合成聚合物、陶瓷和骨材料和/或它们的复合材料,具体取决于特定应用和/或医学从业人员的偏好。例如,脊柱植入物系统10的部件可单独地或共同地由诸如下列的材料制成:不锈钢合金;商业纯钛;钛合金;5级钛;超弹性钛合金;钴铬合金;不锈钢合金;超弹性金属合金(例如,镍钛诺、超弹塑性金属,例如由日本的Toyota Material Incorporated制造的);陶瓷及其复合材料,例如磷酸钙(例如由Biologix Inc.制造的SKELITETM);热塑性塑料,例如,包括聚醚醚酮(PEEK)、聚醚酮酮(PEKK)和聚醚酮(PEK)的聚芳醚酮(PAEK),碳-PEEK复合材料,PEEK-BaSO4聚合橡胶,聚对苯二甲酸乙二醇酯(PET);织物;硅树脂;聚氨酯;硅树脂-聚氨酯共聚物;聚合橡胶;聚烯烃橡胶;水凝胶;半刚性和刚性材料;弹性体;橡胶;热塑性弹性体;热固性弹性体;弹性体复合材料;刚性聚合物,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,包括自体移植物、同种异体移植物、异种移植物或转基因皮质和/或松质骨、和组织生长或分化因子;部分地可再吸收的材料,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和可再吸收聚合物的复合材料;完全地可再吸收的材料,例如,诸如磷酸钙、磷酸三钙(TCP)、羟基磷灰石(HA)-TCP、硫酸钙的钙基陶瓷或诸如聚酮(polyaetide)、聚乙交酯、聚酪氨酸磷酸酯、聚己内酯(polycaroplaetohe)的其它可再吸收的聚合物;以及它们的组合。脊柱植入物系统10的各种部件可具有包括以上材料的材料复合物以实现各种所需的特征,例如强度、刚度、弹性、柔顺性、生物力学性能、耐久性和射线可透性或成像偏好。脊柱植入物系统10的部件单独地或共同地还可由异质材料制造,例如两种或更多种以上所述材料的组合。脊柱植入物系统10的部件可以整体地形成、一体地连接或包括紧固元件和/或器械,如本文所述。
脊柱植入物系统10被用于例如微创手术,包括经皮技术、小切口和开放式外科技术,以在患者身体内的手术部位(例如,脊柱的节段)处递送和引入诸如椎体次全切除术植入物的器械和/或植入物。在一些实施例中,系统10可用于诸如椎体次全切除术和椎间盘切除术的外科手术,其包括采用根据本公开的原理的植入物的融合和/或固定处理,以恢复椎骨的机械支撑功能。
系统10包括植入物20,其具有诸如外部主体22的第一构件,外部主体22具有管形构型。主体22在第一端部24和第二端部26之间延伸并且限定纵向轴线A1。端部26限定基本上平的表面,该表面构造成接合椎骨组织。在一些实施例中,端部26可包括可以是粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的表面,使得它有利于与组织接合。在一些实施例中,椎骨组织可包括椎间组织、终板表面和/或皮质骨。
主体22包括壁,例如管形壁28。壁28包括内表面30,其限定在端部24、26之间延伸的轴向腔体32。在一些实施例中,壁28具有圆柱形横截面。在一些实施例中,壁28的横截面几何形状可具有各种构型,例如,圆形、卵圆形、长圆形、三角形、具有平面或弧形侧部的多边形、不规则的、均一的、不均一的、一致的、可变的、马蹄形、U形或四季豆形。在一些实施例中,表面30为平滑的或平坦的。在一些实施例中,表面30可以是粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的。
壁28限定外侧开口34。开口34构造成用于设置用来有利于主体22的扩张的器械I(图2)和第二构件,例如,如本文所述的植入物20的内部主体44。
表面30包括部分36,如图2所示,其限定邻近端部24设置的周向腔体38。部分36具有基本上平滑或平坦的表面构型,使得腔体38构造成用于设置植入物20的环形部40。环形部40在腔体38内能够可滑动地移动以相对于部分36旋转。在一些实施例中,部分36可以是粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的。
壁28限定开口42,开口42构造成接纳药剂,药剂可包括骨移植物(未示出)和/或其它材料,如本文所述,以用于在例如结合椎体次全切除术使用的固定或融合处理中采用。在一个实施例中,药剂可包括治疗性多核苷酸或多肽和骨生长促进材料,其可被装填或以其它方式设置在包括植入物20的系统10的部件的表面之上或周围。药剂也可包括生物相容性材料,例如:生物相容性金属和/或刚性聚合物,例如,钛元件、钛或钛组合物的金属粉末;无菌骨材料,例如,同种异体移植物或异种移植物材料;合成骨材料,例如,珊瑚和钙组合物,例如羟基磷灰石、磷酸钙和亚硫酸钙;生物活性剂,例如,涂布在植入物20的外部和/或例如通过混合在生物可吸收聚合物中而施加到其以用于逐渐释放的生物活性剂,随着聚合物在患者体内降解,该生物可吸收聚合物以适当的与时间有关的方式释放一种或多种生物活性剂。合适的生物活性剂包括例如骨形态发生蛋白(BMP)和细胞因子。
主体44具有管形构型,并且定向用于设置在轴向腔体32内。主体44相对于轴线A1以线性构型延伸。在一些实施例中,主体44可以以可选构型延伸,例如,弧形的、偏移的、交错的和/或成角度的部分,其可包括锐角、直角和钝角。
主体44在第一端部46和第二端部48之间延伸。主体44包括壁,例如管形壁50。在一些实施例中,壁50具有圆柱形横截面。在一些实施例中,壁50的横截面几何形状可具有各种构型,例如,圆形、卵圆形、长圆形、三角形、具有平面或弧形侧部的多边形、不规则的、均一的、不均一的、一致的、可变的、马蹄形、U形或四季豆形。在一些实施例中,壁50包括外表面52,其为平滑的或平坦的。在一些实施例中,外表面可以是粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的。主体44构造成用于与腔体32设置在一起,使得壁28、50与轴线A1同心。
外表面52的一部分包括端部46的增加的尺寸d,如图4所示。端部46包括沿尺寸d设置的多个阶梯54。阶梯54构造成用于与盖64接合,以提供盖64的选择性定位并且有利于盖相对于轴线A1的旋转。在一些实施例中,端部46包括一个或多个阶梯54。在一些实施例中,端部46和/或端部48可包括可以是平滑的、粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的表面,使得它有利于接合。阶梯54包括接合表面57,其接合下文讨论的止挡件76。接合表面57为止挡件76提供屏障和/或移动范围,从而防止盖64旋转超出所选取向。
壁50包括轴向开口,例如轴向狭槽56。狭槽56具有基本上矩形的构型,以有利于主体44相对于主体22的轴向平移。在一些实施例中,狭槽56可具有各种构型,例如,圆形、卵圆形、长圆形、三角形、具有平面或弧形侧部的多边形、不规则的、均一的或不均一的。狭槽56包括齿轮齿条58,其具有沿其设置的多个齿60。
外表面52的一部分包括具有多个齿63的螺旋齿轮62,齿63可与环形部40接合以有利于植入物20的扩张,如本文所述。齿63以螺旋构型间隔开并且相对于轴线A1设置成角取向,使得主体44能够以螺旋齿轮构型平移。在一些实施例中,植入物20的部件可以通过与不带有环形部构型的主体接合而平移,以使植入物20扩张。
植入物20包括第三构件,例如盖64。盖64包括外表面66和内表面68。表面66构造成用于与组织接合。表面66包括基本上平的表面70,其定向成横向于轴线A1。在一些实施例中,表面70可包括可以是粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的表面,使得它有利于与组织接合。在一些实施例中,表面70可包括开口,其对应于主体44的尺寸和横截面几何形状,以将诸如骨移植物的药剂递送至椎骨终板。
盖64限定第二轴线A2,其能够围绕且相对于轴线A1旋转,并且能够相对于轴线A1以多个角取向α移动,如图2所示。表面70能够随轴线A2在第一角取向和第二角取向之间相对于轴线A1移动。在一个实施例中,表面70和轴线A2能够移动通过基本上0至20度的角范围α。在一些实施例中,角范围α可包括在大约0至10度的范围内的角度α1。在一些实施例中,盖64可与端部46设置在一起,以用于在相对于轴线A1的取向上相对移动,例如,横向的、垂直的和/或其它角取向(例如,锐角或钝角)、同轴的,和/或可以是偏移的或交错的。在一些实施例中,盖64可以在相对于身体的备选平面中相对于端部46移动,例如,身体的竖直面、水平面、对角面、横断面、冠状面和/或矢状面。在一些实施例中,盖64可以在多个轴向构型中相对于端部46移动,使得盖64能够在位于圆锥构型中的多个平面中相对于轴线A1旋转至通过角度范围α和在角度范围α内的所选角度。
表面68包括基本上平的表面71、倾斜表面72和环形表面74。倾斜表面72围绕表面68周向设置。表面71、72、74构造成用于与端部46接合,以有利于盖64相对于轴线A1的旋转,如所描述那样,以响应于表面66与组织的接合而动态地接合端部46。
盖64包括止挡件76,其与内表面68设置在一起。止挡件76构造成限定盖64相对于主体44的至少一个可移动限制器和/或避免植入物20的部件在插入组织期间解体。在一个实施例中,可移动限制器包括多个限制器,每个限制器对应于盖64相对于主体44的多个取向之一。在表面71、72之间的相交部接触阶梯54,以限制盖64的回转。
当器械I旋转时,主体44在轴向方向上被驱动,并且主体44相对于主体22轴向平移。当齿轮56、62接合时,环形部40在腔体38内可滑动地旋转,以在有利于植入物20的扩张的构型中相对于部分36旋转。主体44相对于主体22轴向平移,并且环形部40与其一起设置在第一收缩或嵌套构型和第二扩张构型之间,使得外部主体22和内部主体44设置成接合相邻的椎骨软组织和骨表面,如将描述的,以恢复高度和代替移除的椎骨和/或椎间组织提供支撑。
在操作中,植入物10设置在如图1和5所示的第一构型,使得主体22和主体44设置成与纵向轴线A1的同心构型,并且设置成伸缩布置,以用于递送和植入到邻近手术部位。主体22、44同心地座置,使得内部主体44基本上全部以嵌套构型设置在外部主体22内并且盖64与端部24齐平。当盖64定位成与端部24齐平时,盖64被阻止旋转,以使得植入物20在插入椎骨之间时稳定。在第一取向中,器械I设置在开口34内并且在由图2中的箭头B所示的方向上旋转,使得器械I接合齿60,以用于主体44相对于主体22的轴向平移和环形部40相对于主体22、44的旋转。当器械I在由箭头B所示的方向上旋转时,器械I接合齿60以在由图2中的箭头C所示的轴向方向上驱动主体44,并且引起主体44相对于主体22的轴向平移以使植入物20扩张。在一个实施例中,器械I在由图2中的箭头BB所示的方向上旋转,使得器械I接合齿60以在由图2中的箭头D所示的轴向方向上驱动主体44,并且引起主体44相对于主体22的轴向平移以使植入物20从扩张构型收缩和/或塌缩,如由图2中的箭头D所示。
当器械I在由图2中的箭头B所示的方向上旋转时,主体44在由图2中的箭头C所示的方向上相对于主体22轴向平移,使得环形部40在腔体38内可滑动地旋转以有利于植入物20的扩张。主体44相对于主体22轴向平移到第二扩张取向,如图2和7所示,使得外部主体22和盖64设置在接合相邻的椎骨软组织和骨表面,如将描述的,以恢复高度和代替移除的椎骨和/或椎间组织提供支撑。
植入物20构造成用于沿轴线A1轴向扩张。在一个实施例中,植入物20可以在弓形构型下沿着曲线相对于轴线A1扩张。在一些实施例中,植入物20的全部或仅一部分可以弓形地扩张,例如主体22、44之一或全部可包括相对于纵向轴线A1的曲率。
在一个实施例中,植入物20以在椎骨之间所选量的间距和/或撑开下扩张至第二取向,使得盖64接合第一椎骨表面,并且端部26接合第二椎骨表面,以恢复椎骨间距并提供撑开和/或恢复机械支撑功能。在一个实施例中,如本文所讨论那样,植入物20被渐进地和/或逐渐地扩张以提供构造成适于包括椎骨的患者的生长的植入物。在一些实施例中,植入物20的高度也可以在一定时间段和/或若干手术内减小,以适应患者的各种条件。
在一个实施例中,植入物20构造成用于连续扩张,这包括由于构型和尺寸导致的递增扩张以及所得到的器械I和齿60的接合。在一些实施例中,递增扩张可包括特定线性尺寸的离散增量。在一些实施例中,线性尺寸的增量可包括大约0.1-1.0mm的范围。
如图6所示,当主体44扩张时,如上文所讨论那样,盖64接合椎骨V1。盖64动态地接合椎骨V1,使得当表面66接合椎骨V1时,盖64的轴线A2相对于且围绕轴线A1以角度α旋转,如图2所示。盖64的旋转允许表面66调整其角度,以适应椎骨V1的具体角度。当盖64旋转时,表面71和72围绕端部46平移,以适应表面66的角度变化。止挡件76提供一系列移动限制器,并且抵抗和/或防止盖64围绕轴线A1旋转超出盖64的移动的所选极限。在表面71、72之间的相交部接触阶梯54,以限制盖64的回转。止挡件76构造成接合表面57,以防止盖64旋转。
在一些实施例中,植入物20提供占有面积,其改善稳定性并降低沉陷到组织中的风险。在一些实施例中,植入物20提供在椎体之间的高度恢复、减压、矢状面和/或冠状面平衡的恢复和/或对沉陷到椎骨终板内的阻力。
参看图5和6,在组装、操作和使用中,类似于结合图1-4所述,包括植入物20的系统10被用于外科手术,例如腰椎椎体次全切除术,以用于处理包括椎骨V的患者的脊柱。系统10也可用于其它外科手术,例如,椎间盘切除术、椎板切除术、融合术、椎板切开术、椎板切除术、神经根回缩、椎间孔切开术、椎骨关节面切除术、减压术、脊髓核或椎间盘置换术以及骨移植物和可植入的假体修复术,包括用于植入物20的固连的板、杆和骨接合紧固件。
系统10被用于腰椎椎体次全切除术,包括外科关节固定术,例如,融合以固定关节,以用于治疗脊柱的受影响节段和身体内的相邻区域的适用病症或损伤。例如,椎骨V包括第一椎骨V1和第二椎骨V2。患病和/或受损的椎骨和椎间盘设置在椎骨V1和V2之间。在一些实施例中,系统10构造成用于插入椎间隙内以隔开关节表面、提供支撑和使椎骨V的稳定最大化。
在使用中,为了治疗椎骨V的受影响的节段,医学从业人员以任何适当的方式(诸如通过组织的切开和回缩)获得到包括椎骨V的手术部位的通路。在一些实施例中,系统10可用于任何现有的外科手术方法或技术中,包括开放式手术、小切口手术、微创手术和经皮外科植入,由此通过微切口或提供至该区域的受保护通路的套管接近椎骨。一旦获得到手术部位的通路,就进行椎体次全切除术以用于治疗脊柱疾病。椎骨V的患病和/或受损部分和患病和/或受损的椎间盘被移除,以形成椎间隙S。
准备器械(未示出)用来移除椎间盘组织、流体、相邻组织和/或骨,并且从椎骨V1的终板表面E1和/或椎骨V2的终板表面E2刮削和/或移除组织。植入物20设有至少一种药剂,类似于本文所述和以上所述那些,以促进新骨生长和融合,以处理椎骨V的受影响节段。
植入物10设置在第一取向,如图5所示和上文结合图1-4所述,使得主体22和主体44设置成与纵向轴线A1的同心构型,并且设置成伸缩布置,以用于递送和植入到邻近手术部位。主体22、44同心地座置,使得内部主体44基本上全部以嵌套构型设置在外部主体22内并且盖64与端部24齐平。
植入物20被利用包括驱动器的递送器械(未示出)经由受保护的通路递送至邻近椎骨V的手术部位,以用于关节固定术处理。根据特定外科应用的要求,驱动器将植入物20递送至在椎骨V1和椎骨V2之间经准备的椎间隙S。植入物20被操纵,使得端部26接合终板表面E2。端部26的抓握表面穿透并固定终板表面E2。植入物20与终板表面E2定位在第一取向。
在第一取向中,器械I设置在开口34内并且在由图2中的箭头B所示的方向上旋转,使得器械I接合齿60,以用于主体44相对于主体22的轴向平移和环形部40相对于主体22、44的旋转。当器械I在由箭头B所示的方向上旋转时,器械I接合齿60以在由图2中的箭头C所示的轴向方向上驱动主体44,并且引起主体44相对于主体22的轴向平移以将植入物20扩张到第二取向,如图6所示。这样,植入物20在椎间隙S内扩张并且盖64接合终板表面E1。表面66与终板表面E1固定在一起。在一个实施例中,器械I在由图2中的箭头BB所示的方向上旋转,使得器械I接合齿60以在由图2中的箭头D所示的轴向方向上驱动主体44,并且引起主体44相对于主体22的轴向平移以使植入物20从扩张构型收缩和/或塌缩。
盖64动态地接合椎骨V1,使得表面66接合椎骨V1,并且轴线A2围绕轴线A1以角度α旋转,如图2所示。盖64的旋转允许表面66选择性地调整其角度,以适应椎骨V1的具体角度。当盖64旋转时,表面71和72围绕端部46平移,以适应表面66的角度变化。在表面71、72之间的相交部接触阶梯54,以限制盖64的回转。止挡件76防止盖64围绕轴线A1旋转,如所描述那样。
植入物20接合并间隔开相对的终板表面E1、E2,并且固连在椎间隙S内,以稳定和固定与骨生长有关的椎骨V的部分,以用于椎骨V1、V2的融合和固定。植入物20与终板表面E1、E2的固定可通过由关节空间提供的阻力和/或与终板表面E1、E2的接合而便利化。可提供锁以防止主体44相对于主体22轴向平移,以将植入物20固定在所选的扩张和/或收缩取向,包括本文所述那些。
在一些实施例中,植入物20可以仅接合一个终板。在一些实施例中,可将本文所述药剂施加到手术部位的区域,以促进骨生长。包括植入物20的系统10的部件可作为预组装装置递送或植入或者可以就地组装。包括植入物20的系统10的部件可以完全或部分地就地修正、移除或置换。在一些实施例中,系统10的部件中的一个或全部可通过机械操纵和/或徒手技术递送到手术部位。
在一个实施例中,植入物20可包括紧固元件,其可包括锁定结构,该锁定结构构造成用于与椎骨V1、V2的固定,以固连关节表面并将互补的稳定和固定提供到椎骨区域。在一些实施例中,锁定结构可包括紧固元件,例如,杆、板、夹片、吊钩、粘合剂和/或凸缘。在一些实施例中,系统10可与螺钉一起使用以加强固定。在一些实施例中,系统10和任何螺钉及附件可以涂有类似于本文所述那些的药剂,以用于加强到处理区域的骨固定。系统10的部件可由诸如聚合物的射线可透材料制成。可包括无线电指示标以用于在X光、荧光镜透视检查、CT或其它成像技术下识别。
在一个实施例中,系统10包括多个植入物20。在一些实施例中,采用多个植入物20可优化椎间隙S可被间隔开的量,使得关节间距尺寸可被预选。多个植入物20可被定向成并列接合、间隔开和/或交错的。
在一些实施例中,借助于系统10,使用显微外科和图像引导技术可用于接近、观察和修复脊柱退化或损伤。在完成手术后,移除系统10、外科器械和组件的未植入部件,并且闭合切口。
在一个实施例中,如图7-9所示,系统10包括植入物20,类似于上文结合图1-6所描述那样,植入物20具有上述外部主体22和内部主体144。主体144具有管形构型,并且定向用于设置在轴向腔体32内。主体144相对于轴线A1以线性构型延伸。主体144在第一端部146和第二端部148之间延伸。主体144包括壁,例如管形壁150。主体144构造成用于与腔体32设置在一起,使得壁28、150与轴线A1同心。
在端部146处的外表面152的一部分限定至少一个腔体154。腔体154构造成用于盖164的可移动设置,如下文所讨论的。腔体154有利于盖164和端部146的动态接合。在一个实施例中,植入物20包括两个腔体154、155。腔体154、155各自包括基本上球形的表面180、181,并且表面182、183和184、185各自横向于轴线A1。在一些实施例中,表面180、181、182、183、184、185可包括可以是平滑的、粗糙的、纹理化的、多孔的、半多孔的、带浅凹的和/或抛光的表面,使得它有利于接合。表面180、181、182、183、184、185构造成为止挡件限制器以限制盖164的移动。
壁150包括轴向狭槽156。狭槽156具有基本上矩形的构型,以有利于主体144相对于主体22的轴向平移。狭槽156包括齿轮齿条158,其具有沿其设置的多个齿160。
外表面152的一部分包括具有多个齿163的螺旋齿轮162,齿163可与环形部40接合以有利于植入物20的扩张,如本文所述。齿163以螺旋构型间隔开并且相对于轴线A1设置成角取向,使得主体144能够以螺旋齿轮构型平移。
植入物20包括第三构件,例如盖164。盖164包括外表面166和内表面168。表面166构造成用于与组织接合。表面166包括基本上平的表面170,其定向成横向于轴线A1。盖164包括柱186,其设置在盖164的一侧上。柱186延伸进入腔体154并且与腔体154可移动地设置在一起。盖164包括在表面166和168之间延伸的开口188。开口188构造成接纳可移动的柱190。柱190包括旋钮部分192和杆部分194。杆部分194构造成用于可移动地设置在腔体155中。柱186和190有利于盖164在由图9中的箭头E所示的方向上的旋转移动。腔体154、155有利于盖164在由图9中的箭头F所示的方向上的旋转。
盖164限定轴线A3,其能够相对于轴线A1以多个轴向角取向β移动,如图7所示。表面170能够相对于轴线A1移动,其中轴线A2在第一角取向和第二角取向之间。在一个实施例中,角范围β为基本上0至20度。在一些实施例中,角度β1可包括大约0至10度的范围。在一些实施例中,盖164可与端部146设置在一起,以用于在相对于轴线A1的取向上相对移动,例如,横向的、垂直的和/或其它角取向(例如,锐角或钝角)、同轴的,和/或可以是偏移的或交错的。在一些实施例中,盖164可以在相对于身体的备选平面中相对于端部146移动,例如,身体的竖直面、水平面、对角面、横断面、冠状面和/或矢状面。在一些实施例中,盖164可以在多个轴向构型中相对于端部46移动,使得盖164能够在位于圆锥构型中的多个平面中相对于轴线A1旋转至通过角度范围α和在角度范围α内的所选角度。
表面168包括基本上平的表面169和环形表面174。表面169、174构造成用于与端部146接合,以有利于盖164相对于轴线A1的旋转,以响应于外表面166与组织的接合而动态地接合端部146。
盖164的移动由腔体154、155的表面180、181、182、183、184、185限制。当盖164旋转时,柱186沿着表面180平移,直到其接触表面182或184中任一者。当柱186接触任一表面182、184时,其防止盖164的进一步旋转。当盖164旋转时,柱194沿着表面181平移,直到其接触表面183或185中任一者。当柱194接触任一表面183、185时,其抵抗和/或防止盖164的旋转。
盖164动态地接合椎骨,使得当表面166接合椎骨时,轴线A3相对于轴线A1成角度β旋转,如图7所示。盖164的旋转允许表面166选择性地调整其角度,以适应椎骨的具体角度。当盖164旋转时,表面169和174围绕端部146平移,以适应表面166的角度变化。腔体154、155抵抗和/或防止盖164围绕轴线A4旋转,以提供对盖164的移动的限制。
在一个实施例中,如图10所示,系统10包括植入物20,类似于上述系统和方法,包括内部主体244。主体244在第一端部246和第二端部248之间延伸。主体244包括盖264。盖264包括止挡件276,类似于上述止挡件76。在端部246处的外表面252的一部分限定至少一个腔体254。腔体254构造成用于盖264的可移动设置,如上文所讨论的。腔体254有利于盖264和端部246的动态接合。类似于上述盖64,盖264为铰接端盖,其调整以匹配椎骨终板的取向,并且选择性地确定盖264的取向(例如,所需角度),以用于与椎骨终板接合。该构型有利于椎骨的压缩负载的分布,并可适应身体的矢状面和/或冠状面中的轴向偏移,类似于本文所述那样。盖264包括柱286,类似于柱186,其设置在盖264的至少一侧上。柱286延伸进入腔体154并且与腔体154可移动地一起设置,以有利于和限制盖264的移动,如上文所讨论那样。该构型有利于两个不同的自由度,以允许盖264相对于端部246的关节运动。
应当理解,可对本文所公开的实施例做各种修改。因此,以上描述不应理解为限制性的,而仅理解为各种实施例的例示。本领域的技术人员将设想在所附的权利要求书的范围和精神内的其它修改。
Claims (16)
1.一种脊柱植入物,包括:
第一构件,所述第一构件包括限定轴向腔体的壁;
第二构件,所述第二构件在第一端部和第二端部之间延伸并限定纵向轴线,所述第二构件构造成用于与所述轴向腔体一起设置并相对于所述第一构件平移;以及
第三构件,所述第三构件包括能够与组织接合的外表面和内表面,所述内表面设置成响应于所述外表面与所述组织的接合而动态地接合所述第一端部,
其中,所述第一端部包括限定至少一个腔体的外表面,所述至少一个腔体构造成用于所述第三构件的一部分的可移动设置以有利于动态接合。
2.根据权利要求1所述的脊柱植入物,其特征在于,所述第三构件限定第一轴线,所述第一轴线能够在多个轴向取向上相对于所述纵向轴线移动。
3.根据权利要求1所述的脊柱植入物,其特征在于,所述外表面包括基本上平的表面,所述基本上平的表面定向成横向于所述纵向轴线并且能够相对于所述组织的取向移动。
4.根据权利要求3所述的脊柱植入物,其特征在于,所述平表面能够相对于所述纵向轴线在基本上0至20度的角范围内移动。
5.根据权利要求1所述的脊柱植入物,其特征在于,所述外表面包括基本上平的表面,所述基本上平的表面能够相对于所述纵向轴线在第一角取向和第二角取向之间移动。
6.根据权利要求4所述的脊柱植入物,其特征在于,所述第二角取向设置在相对于所述第一角取向基本上10度处。
7.根据权利要求1所述的脊柱植入物,其特征在于,所述第三构件包括止挡件,所述止挡件限定所述第三构件相对于所述第二构件的至少一个可移动的限制器。
8.根据权利要求7所述的脊柱植入物,其特征在于,所述至少一个可移动的限制器包括多个限制器,每个限制器对应于所述第三构件相对于所述第二构件的多个取向之一。
9.根据权利要求1所述的脊柱植入物,其特征在于,所述内表面限定构造用于设置环形部的周向凹槽,所述环形部限定所述第三构件相对于所述第二构件的至少一个可移动的限制器。
10.根据权利要求1所述的脊柱植入物,其特征在于,所述内表面包括周向围绕其设置的倾斜表面,所述倾斜表面能够与所述第一端部接合以有利于所述第三构件相对于所述纵向轴线的旋转。
11.根据权利要求1所述的脊柱植入物,其特征在于,所述内表面包括基本上平的表面、周向围绕其设置的倾斜表面和环形表面,所述内表面的所述表面能够与所述第一端部接合以有利于所述第三构件相对于所述纵向轴线的旋转。
12.根据权利要求1所述的脊柱植入物,其特征在于,所述第一端部包括限定所述第一端部的增加的尺寸的外表面,所述增加的尺寸能够与所述内表面接合以有利于所述第三构件相对于所述纵向轴线的旋转。
13.根据权利要求1所述的脊柱植入物,其特征在于,所述第一端部包括限定至少一个阶梯的外表面,所述至少一个阶梯能够与所述内表面接合以有利于所述第三构件相对于所述纵向轴线的旋转。
14.根据权利要求1所述的脊柱植入物,其特征在于,所述第一端部包括限定多个阶梯的外表面,所述多个阶梯限定所述第一端部的增加的尺寸,所述阶梯能够与所述内表面接合以有利于所述第三构件相对于所述纵向轴线的旋转。
15.根据权利要求1所述的脊柱植入物,其特征在于,所述至少一个腔体的表面限定所述第三构件相对于所述第二构件的至少一个可移动的限制器。
16.根据权利要求1所述的脊柱植入物,其特征在于,所述第一端部包括限定外侧开口的外表面,并且所述第三构件包括能够相对于所述第三构件旋转的外侧柱,所述柱设置用于在所述开口内平移以有利于动态接合。
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