CN101123929A - 用于微创脊椎面关节半关节置换术中的植入装置 - Google Patents

用于微创脊椎面关节半关节置换术中的植入装置 Download PDF

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CN101123929A
CN101123929A CNA2005800398145A CN200580039814A CN101123929A CN 101123929 A CN101123929 A CN 101123929A CN A2005800398145 A CNA2005800398145 A CN A2005800398145A CN 200580039814 A CN200580039814 A CN 200580039814A CN 101123929 A CN101123929 A CN 101123929A
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facet joint
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大卫·A.·彼德森
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    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4405—Joints for the spine, e.g. vertebrae, spinal discs for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

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Abstract

一种金属倒置L型植入物用于再造下面椎骨的上脊椎面表面，上脊椎面表面限于位于脊柱中的脊椎面关节，即枕骨－C1到L5－S1。该金属植入物在其外表面上是高度抛光的，在其内表面上是粗糙的。其被机械地卷曲在位置中，无需使用接合剂或椎弓根螺钉。当骨头生长在该植入物内部的粗糙、多孔表面上时，形成永久固定。该用于半关节成形术方法中的植入物在坏死的或患病的脊柱脊椎面关节中再造半个脊椎面关节表面来提供光滑、无痛的关节连接，无需大的手术或复原，对患者的风险非常小。

Description

用于微创脊椎面关节半关节置换术中的植入装置
技术领域
本发明总体涉及一种用于微创脊柱手术中的装置。更具体地，涉及一种预制、预成型金属植入物，使用关节内视镜检查式入口或传统的开放手术方法植入，来实现脊椎面关节半关节置换，从而再造任一或所有48个从下枕骨-C1到L5-S1椎骨的上脊椎面。
背景技术
仅在美国，全部人口的约10％会在接下来的12个月中的某个时候遭受背痛。更多的人会在接下来的一年与背痛相约，其数量比患有除了普通感冒和流感的任何其它伤害或疾病还多。约三分之一的患者不会恢复，并且不得不带着顽固的致残的症状生活。该数量将逐年递增。
引起背痛，特别是顽固的致残的背痛的根本原因之一是位于脊柱中相邻椎骨后面的允许做脊柱运动的脊椎面关节，又叫小关节。
目前可用于患有脊椎面关节官能障碍的数百万人的手术方案为复杂的、侵入的高风险手术，需要用椎弓根螺钉固定，大量减少或去除天然关节，并且用例如美国专利6610091，6579319，6132464，6113637和美国专利申请2003/0028250中描述的修复设备代替。通常，该现有技术需要6个月到24个月长的恢复期，并且后果不确定。高风险等同于频繁起诉，这在该疾病或伤害的后果日益变坏时，推动了非手术症状处理的发展。
随着新的、更安全的、创口更小的外科方法和技术的出现，脊柱手术的发展现在超过任何其他整形外科部分的速度。其发展由巨大的需求进一步推动。需要对用于脊柱关节的装置做出改进。
发明内容
本发明提供一种用于微创脊柱手术中的预制、预成型的金属植入物。本发明将预成型金属覆层用于脊椎面关节，用于患病的、疼痛的、坏死的或变形的关节面的再造表面，相对于更大的修复植入物具有三个优点；即(1)使用薄的金属覆层允许用于微创插入，其更安全，创伤更小，并且恢复时间远短于修复手术方法；(2)该覆层不需要使用接合剂、椎弓根螺钉或其他固定方法，这些固定方法会随着时间使其固定变松；和(3)该植入物具有两个翅片或叶片，来提供侧部稳定性，并且具有两个齿，来提供临时固定，还具有粗糙或多孔的内表面，可适用于生长的骨头，提供永久性自然固定。该插入物还具有抛光的外表面，使关节光滑、自然、无痛地连接。
该插入物特别设计用于关节内视镜式入口中，用于独立的过程，但是也可用于传统的开放式手术中。该植入物提供独特的更牢固和更好的表面再造，并且可用于，但是不限于：(1)辅助脊椎通过器械的融合(instrumented vertebralfusion)，此时，直接插入位于与所使用的器械邻接的两个关节上方和下方的两个脊椎面关节中，由此消除由于施加到脊椎面关节上的附加应力产生的伴随的手术后脊椎面关节疼痛的风险，(2)用于直接在椎间盘替代物上方和下方的相邻脊椎面关节再造表面，通过消除由该椎间盘替代物施加到脊椎面关节上的附加应力产生的伴随的手术后脊椎面关节疼痛，和(3)作为患病的、疼痛的或坏死的脊椎面关节的独立处理。
本发明通过提供用于再造表面的植入物来将关节表面替代为小的骨上金属覆层来实现其再造表面的疼痛的、患病的或坏死的脊椎面关节的目的。该覆层由钴铬或其他生物适用金属或适用于关节半关节置换术的金属合金构成，其尺寸为用于脊柱各块椎骨的多个尺寸之一，同样地，尺寸制成用于脊柱中不同的脊椎面关节或关节组，并且使用简单方法连接到关节，而无需螺钉或接合剂。可使用关节内视镜式入口进入脊椎面关节，不需要开放手术、住院治疗和长恢复期。该方法也可用作对其他方法的辅助，例如传统开放手术中通过器械的融合和椎间盘替换。由于连接到骨的植入物的侧部是多孔的，骨在其上愈合，将其永久地固定在位。独特设计的一组叶片和齿提供到关节的临时固定，防止移动。卷曲系统使该植入物固定在位置中，将其牢固固定，直到骨头完全生长。与关节接触的侧部被高度抛光，提供光滑的、几乎无摩擦的表面，几乎不会出现磨损和撕裂。内部粗糙或多孔，来为生长的骨提供适应表面。
根据本发明的一个广义方面，提供一种独特的金属修复覆层。该金属覆层通常形状制成其再造的骨头表面的天然形状轮廓，并且在外表面高度抛光，来提供关节的无摩擦连接，并且内部粗糙或多孔，来提供表面促使天然骨生长到该覆层中，由此提供永久固定。在植入和骨头生长的中间时期，该覆层使用彼此相对的两个齿和一到两个位于植入物内表面上的侵入骨中防止侧向移动的叶片机械地弯曲在位置中。该覆层还通过该关节的上下侧面由于在其自然位置集在一起的自然压力固定在位置中。
插入该修复覆层的系统包括任意数量的器械，用来使用微创手术关节镜技术进入关节中，使关节和将放置的植入物做好准备，该器械包括导向探测器，用于确定正确的脊椎面关节角度；分离器，用来辅助椎骨分离，以更好地进入关节；骨凿，用于在骨中进行小的切割，来准备用于植入物的表面；手钻，用于使骨与植入物形状匹配；锤子，用于将植入物敲击在位置中；和卷曲机，用于在愈合前将植入物固定来防止移动；和植入物。仅作为示例，该导向探测器可包括平面刀片或锉刀，来去除任何骨刺或骨质增生，并且使脊椎面关节表面变平，为放置植入物做准备。
附图说明
通过参考附图阅读该说明书，本发明的很多优点将对本领域的技术人员显而易见，附图中相同的参考标记用于相同的部件，其中
图1显示了植入物的右侧俯视立体图；
图2显示了植入物的左侧仰视立体图；
图3显示了沿图1中3-3线的剖视图；
图4显示了用于准备容纳该植入物的脊椎面关节的工具；
图5显示了插入脊椎面关节中的工具；
图6显示了将要安装到脊椎面关节中的插入物；
图7显示了嵌入在脊椎面关节中的插入物；
图8显示了沿图7中8-8线的剖视图。
具体实施方式
参考图1，本发明的修复植入物10具有高度抛光的凹入外背部12和顶部14上高度抛光的凸面。该高度抛光的表面为钴-铬合金、钛合金或能够形成光滑的高度抛光表面的其他生物适用材料。参考图2，内凸面为粗糙表面18，来促进新骨的生长和附着。固定到内表面16的叶片20和22侵入骨头来促进固定。植入物10顶部的下表面24凹入来在骨头上形成紧配合，如图7和8中所示。齿26和28用于嵌入相邻的骨中，来防止植入物10移动。
在将植入物嵌入脊椎面关节32中之前，使用准备工具30来将该关节32轻微分离。工具端部34插入该关节32中，来提供足够的用于将植入物10插入关节32中的空间，如图7和8中所示。
该修复植入物10的使用与现有技术相比具有两个优点：
(1)其创口小，风险低，速度快(在门诊部每个关节约20分钟，与住院3小时及随后三天仍需住院相比较)，并且具有短的几周的恢复期(与6到24个月相比较)；和
(2)其具有高成功率，不排除其他外科手术，并且没有限制，是永久的。
本发明的目的是克服或至少改进现有技术的缺点，通过以下步骤实现：
逆转与本发明相对的现有方法的风险/收益率；
独立的微创方法，与主要开放的手术相比较；
用作对长融合和椎间盘更换手术相关的主要开放手术的辅助，来加强相邻的脊椎面关节；
门诊手术与住院手术相比较(约20分钟每关节与数小时相比较)；
减少发病率；
减少失血；
缩短在关节镜下的时间；
降低风险；
恢复期显著缩短；
疤痕微小，减少了不成功的背部综合症的风险，并且改善了修复手术的后果；
通过显著降低手术室时间及软组织破坏，降低了手术后感染的风险；
延长了长椎骨融合及椎间盘更换的功能寿命；
不排除其他外科或非侵入治疗选择；和
通过利用已经认可的由关节镜技术和再造表面植入物促进的方法，显示出高的成功率。
可以预料的是，该方法、器械和植入物的实用性将增加所进行的手术的数量，因为其为引起关节疼痛的主要原因提供第一安全的门诊方案。发明人也期望接受该方法的几乎所有的患者在手术当天就能够行走，并且在几周内就能够完全恢复功能。现有技术的手术方案需要住院约三天，并且六到二十四个月的恢复期。
除了明显的绝对的临床结果，对伤残、工人赔偿金和医疗保险的金融显著的有利的影响也是相当大的。
脊柱的脊椎面植入物单元根据每个关节进行了计算。每个患者每块脊椎具有两个关节，腰椎中具有六块椎骨(T12-L1到L5-S1)，或者12个腰椎关节、14个颈椎关节和28个胸椎关节。每一次手术可能涉及多个关节，平均概率为每个患者4个。
本发明通过提供一种以小的骨上金属覆层代替关节表面的再造表面植入物实现本发明减少、防止或消除脊柱面关节疼痛的目的。该覆层由钴铬构成，其为之前已经由FDA认可的用于其他半关节置换术的材料，或由其他可安全使用的金属结构构成，该覆层尺寸制成用于脊柱的各块椎骨的多个尺寸之一，类似地尺寸可制成用于不同的关节，并且使用简单方法固定到关节，无需螺钉、接合剂及传统设计的器械的辅助。该关节使用关节镜式入口进入，不需要开放手术、住院治疗和长的恢复期(除非该方法用于辅助其他方法，例如传统开放手术中的通过器械融合和椎间盘更换)。因为固定到骨头的该侧部为多孔的，骨头在其上愈合，将其永久地固定在位置中。独特设计的叶片和齿用于关节，并且独特的卷曲系统使植入物固定在位置中，使其牢固的固定，直到骨头生长完成。与关节接触的侧部被高度抛光，提供光滑的、几乎无摩擦的表面，几乎不会出现磨损和撕裂。再造表面植入物为脊柱的面关节的牢固固定的多孔半关节形成术。
金属覆层通常形状制成其再造表面的骨头的天然形状，并且外表面高度抛光，来提供关节的无摩擦连接，并且内表面上粗糙和多孔，来提供表面，促使天然骨头生长入覆层中，由此提供永久固定。在植入和固体生长的中间时期，该覆层通过使用两个侵入骨头来防止移动的彼此相对的齿机械地卷入位置中。该覆层还通过关节的上下部由于在其自然位置集一起的自然压力进一步固定在位置中。
该系统包括任意数量的器械30，为使用微创外科关节置换技术进入关节，来使关节32和将要放置的植入物10做好准备，该器械30包括导向探测器，用于确定正确的脊椎面关节角度；分离器，用来辅助椎骨分离，以更好地进入关节；骨凿，用于在骨中进行小的切割，来准备用于植入物的表面；手钻，用于使骨与植入物形状匹配；锤子，用于将植入物敲击在位置中；和卷曲机，用于在愈合前将植入物固定来防止移动；和植入物。仅作为示例，该导向探测器可包括平面刀片或锉刀，来去除任何骨刺或骨质增生，并且使脊椎面关节表面变平，为放置植入物做准备。
等同部件可用于代替本发明的植入物部件，来以基本相同的方式提供基本相同的功能，获得基本相同的效果。

Claims (17)

1.一种用于微创脊椎面关节半关节置换术中的修复植入物，所述植入物包括：
倒置的L型金属主体，具有凸出顶部，在后边缘与凹入的向下延伸部分一体形成，所述顶部和向下延伸部分具有高度抛光的与骨头生物相容的材料的外表面；
凹入的下表面，在顶部下方，  和凸出的内粗糙表面，在向下延伸部分上；和
至少一个叶片，与凸出内粗糙表面一体化形成，和一对齿，从凸出顶部前边缘延伸。
2.根据权利要求1所述的修复植入物，其中，所述高度抛光外表面为钴-铬合金。
3.根据权利要求1所述的修复植入物，其中，所述高度抛光的外表面为钛合金。
4.根据权利要求1所述的修复植入物，其中，所述凸出的内粗糙表面为多孔的，并且与骨头相容。
5.根据权利要求1所述的修复植入物，其中，具有两个与凸出内粗糙表面一体化形成的叶片。
6.一种安装在脊椎面关节中的修复植入物，所述植入物包括：
倒置的L型金属主体，具有凸出顶部，在后边缘处与凹入的向下延伸部分一体形成，所述顶部和向下延伸部分具有高度抛光的与骨头生物相容的材料的外表面；
凹入的下表面，在顶部下方，  和凸出的内粗糙表面，在向下延伸部分上；和
至少一个叶片，与凸出内粗糙表面一体化形成，和一对齿，从所述凸出顶部前边缘延伸。
7.根据权利要求6的安装在脊椎面关节中的修复植入物，其中，所述高度抛光的外表面与所述脊椎面关节中相对定位的骨头并置。
8.根据权利要求7的安装在脊椎面关节中的修复植入物，其中，所述高度抛光的外表面为钴-铬合金。
9.根据权利要求7的安装在脊椎面关节中的修复植入物，其中，所述高度抛光的外表面为钛合金。
10.根据权利要求6的安装在脊椎面关节中的修复植入物，其中，所述粗糙表面与并置的骨头的形状相符。
11.根据权利要求10的安装在脊椎面关节中的修复植入物，其中，具有两个与凸出内粗糙表面一体化形成的叶片，所述叶片切入并置的骨头内。
12.根据权利要求6的安装在脊椎面关节中的修复植入物，其中所述一对齿向下延伸到骨头中。
13.一种在脊椎面关节中安装修复植入物的系统，使用一种工具，将所述脊椎面关节分开足够大来使所述植入物进入，所述植入物包括：
倒置的L型金属主体，具有凸出顶部，在后边缘处与凹入的向下延伸部分一体形成，顶部和向下延伸部分具有高度抛光的与骨头生物相容的材料的外表面；
凹入的下表面，在顶部下方，  和凸出的内粗糙表面，在向下延伸部分上；和
至少一个叶片，与凸出内粗糙表面一体化形成，和一对齿，从凸出顶部前边缘延伸。
14.根据权利要求13所述的系统，其中所述植入物具有高度抛光的钴-铬合金外表面。
15.根据权利要求13所述的系统，其中所述植入物具有高度抛光的钛合金外表面。
16.根据权利要求13所述的系统，其中所述植入物具有两个与凸出内粗糙表面一体化形成的叶片。
17.根据权利要求13所述的系统，其中所述植入物凸出内粗糙表面为多孔的，并且与骨头相容。
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US20060111780A1 (en) 2006-05-25
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US20090182377A1 (en) 2009-07-16
US20060111781A1 (en) 2006-05-25

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