CN102361601B - 骶髂关节固着融合系统 - Google Patents

骶髂关节固着融合系统 Download PDF

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CN102361601B
CN102361601B CN 201180001537 CN201180001537A CN102361601B CN 102361601 B CN102361601 B CN 102361601B CN 201180001537 CN201180001537 CN 201180001537 CN 201180001537 A CN201180001537 A CN 201180001537A CN 102361601 B CN102361601 B CN 102361601B
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爱德华·杰佛瑞·唐纳
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Jcbd公司
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    • A61B17/17Guides or aligning means for drills, mills, pins or wires
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Abstract

本发明系关于一种骶髂关节固着融合系统,其提供一种固着且融合骶髂关节的方法及一种在置放于骶髂关节的关节区域内时有助于骶髂关节的稳定性及融合的骶髂关节植入物。

Description

骶髂关节固着融合系统

[0001] 本国际专利合作条约专利申请案主张2010年I月13日申请的美国临时专利申请案第61/335,947号的权利,该临时专利申请案特此以全文引用的方式并入本文中。

技术领域

[0002] 一般而言,本发明系关于一种骶髂关节固着融合系统,其提供一种固着且融合骶髂关节的方法及一种在置放于骶髂关节的关节间隙内时有助于骶髂关节的稳定性及融合的骶髂关节植入物。

背景技术

[0003] 骶髂关节为在骨盆的骶骨与髂骨之间的由韧带接合的关节。在人类中,骶骨支撑脊椎且又由每一侧上的髂骨支撑。骶髂关节为具有关节软骨及会产生两骨的连锁的不规则隆起及凹陷的滑动关节。

[0004] 与骶髂关节相关的疼痛可由骨盆的创伤性骨折脱位、退化性关节炎、骶髂关节炎(sacroiliitis)(骶髂关节的一种发炎或退化病状)、致密性髂骨炎(osteitis condensansilii)或骶髂关节的其它退化病状引起。当前,此等病状的最为提倡的外科疗法是骶髂关节融合。骶髂关节的融合可藉由若干不同现有方法达成,该等方法涵盖前路方法、后路方法及侧路方法,伴有或不伴有经皮螺钉或其它类型的植入物固着。然而,尽管此等方法的每一者在过去的数十年中皆已用于骶髂关节的固着及融合,但关于骶髂关节固着及融合的实质性问题仍未经解决。

[0005] 伴随用于固着且融合骶髂关节的某些现有方法(包括前路方法、后路方法或侧路方法)的一个显著问题可为外科医师必须在皮肤及组织中产生实质性切口以直接接近所涉及的骶髂关节。此等侵袭性方法允许骶髂关节由外科医师直接看见及触及。常称为「切开手术(open surgery)」的此等程序具有要求全身麻醉的相伴缺点且可由于由切开手术引起的广泛软组织损伤而涉及手术时间、住院期、疼痛及恢复时间增加。使用前路方法进行切开手术的一个危险可为对位于骶髂关节内侧约2公分处的L5神经根的损伤或对主要血管的损伤。另外,此等程序典型地涉及藉由置放一或多个螺钉或藉由置放一或多个经髂植入物(如由图1的非限制性实例所示)或藉由将植入物置放入SI椎弓根(pedicle)及髂骨中来固着骶髂关节(使骶髂关节的关节面相对于彼此不动)。经髂及SI椎弓根髂骨植入物的使用亦可涉及损伤腰骶神经血管组件的风险。因使用此等程序所致的腰骶神经血管组件损伤以及骶髂关节的延迟结合或不结合可能需要进行用以移除所有或部分植入物的翻修手术或关于此等并发症的重复手术。

[0006] 伴随利用侵袭性最小的小切开程序的现有程序的另一显著问题可为由于需要双平面荧光检查骶髂关节的关节面及广泛外科训练及经验,该等程序在技术上有难度。不管外科训练及经验的程度如何,始终常常发生对腰骶神经血管组件的损伤。另外,骶骨畸形可进一步导致植入物的不良置放,从而引起周围结构损伤。另外,此等程序常在骶髂关节未融合的情况下进行,此不移除退化关节面且藉此不处理可能引起骶髂关节持续或复发性疼痛的骶髂关节退化病状。

[0007] 伴随现有程序的另一显著问题可为利用多个不包括有螺纹表面的经髂狭长植入物。此方法需要在骨盆及邻近骶骨孔中产生经髂孔,其可具有相对较大尺寸且随后用仪器进行拉削,其可导致骨被挤入骨盆及神经孔(neuroforamen)中。

[0008] 产生经髂孔及随后对孔进行拉削需要导销,其可能会无意中进入骨盆或骶骨孔中,从而导致其它结构的损伤。另外,产生经髂孔、拉削、或置放狭长植入物可能导致腰骶神经血管组件损伤,如上所论述。另外,骶髂关节的关节部分可能无实际融合,此可能导致需要额外手术的持续或复发性疼痛。

[0009] 伴随现有程序的另一实质性问题可为置放如Stark的美国专利申请案第10/797,481号中的实例所述的后路关节外牵引融合植入物及骨移植物就移除关节面或预备皮质骨、植入物结构及固着骶髂关节而言可能不足够。方法可能不会移除骶髂关节的足够量的关节面或皮质面以减轻骶髂关节疼痛。对于充分固着或融合而言,所述植入物结构与骶髂关节的关节面或皮质骨的啮合可能不足或无效。用Stark申请案所述的植入物结构及方法不能充分稳定且融合骶髂关节可能导致不能减轻所治疗的骶髂关节病状。另外,如Stark所述的驱动骶骨与髂骨分开的方法可能导致骶髂关节的不良对准及增加的疼痛。

[0010] 本文所述的本发明髂融合系统处理与骶髂关节的固着及融合中使用的现有方法及装置相关联的问题。

发明内容

[0011] 因此,本发明的一广泛目标可为提供用于固着且融合骶髂关节的本发明骶髂关节植入物。该骶髂关节植入物的具体实例可提供狭长本体,其可进一步包括自该狭长本体的纵轴径向向外延伸一定距离,适于在骶髂关节的关节面之间进行非横向置放的至少I个径向部件或一对部件,且关于某些具体实例,其可进一步提供各自适于自该狭长本体的纵轴径向向外延伸一定距离进入骶骨或髂骨的骨中的第三径向部件及另外第四径向部件。

[0012] 本发明的另一广泛目标可为提供利用本发明髂植入物的用于固着且融合骶髂关节的本发明方法。本发明方法包含进行侵袭性最小之后路手术的步骤,该手术允许接近骶髂关节之后路态样以达成移除骶髂关节的关节面之间的可由上述髂植入物的具体实例置换的足够部分的关节软骨或组织。可移除骶髂关节的软骨下骨的一部分以在骶髂关节平面中提供植入物接收间隙(非经髂),其经组态以允许狭长部件、或具有在植入物接收间隙的相对表面之间的至少第一径向部件的狭长部件的干涉配合(interference fitting)。本发明方法可进一步包括提供具有一或多个切入骨(包括软骨下骨、皮质骨或疏松骨的一或多者)中的径向部件接收通道的植入物接收间隙,且藉此将一或多个径向部件定位在骶骨的骨或髂骨的骨中的步骤。本发明方法避免现有的经髂置放由杆(rod)接合的固着组件或SI椎弓根及髂内螺钉,同时提供骶髂关节的即刻固着。

[0013] 本发明的另一广泛目标可为提供一或多个骨向内生长孔隙组件,其在一或多个径向部件的相反表面之间或贯穿大体上线性的狭长本体连通,各组件具有允许骶骨及髂骨的骨生长入植入物中或贯穿植入物生长以有助于骶骨与髂骨融合及骶髂关节固着的组态。

[0014] 本发明的另一广泛目标可为提供沿植入物长度具有一定量的弯度的本发明固着融合植入物的特定具体实例,该弯度允许置放固着融合植入物的具有增加的表面积,保持或实质上保持在骶髂关节的关节部分内的具体实例。

[0015]当然,贯穿本说明书、图式、像片及申请专利范围的其它区域揭示了本发明的其它目标。

附图说明

[0016] 图1为骨盆区域及用于稳定骶髂关节的现有方法及器件的前视图;

[0017] 图2为骶髂关节植入物的特定具体实例的透视图;

[0018] 图3为骶髂关节植入物的特定具体实例的第一侧视图;

[0019]图4为骶髂关节植入物的特定具体实例的第一植入物端视图;

[0020]图5为骶髂关节植入物的特定具体实例的第二植入物端视图;

[0021]图6为图3中所示的骶髂关节的特定具体实例的关于纵轴旋转约90度的第二侧视图;

[0022] 图7为骶髂关节植入物的第二特定具体实例的透视图;

[0023]图8为具有涂布材料的固着融合植入物的另一特定具体实例的第一侧视图,该涂布材料有助于固着融合植入物与骨的骨整合;

[0024]图9为固着融合植入物的彼特定具体实例的如图8中所示的横截面8-8 ;

[0025] 图10为沿纵轴具有一定量的弯度的骶髂关节植入物的一具体实例的透视图;

[0026]图11为图10中所示的固着融合植入物的特定具体实例的第一侧视图;

[0027]图12为图11中所示的固着融合植入物的特定具体实例的第一植入物端视图;

[0028]图13为图11中所示的固着融合植入物的特定具体实例的第二植入物端视图;

[0029]图14为图11中所示的固着融合植入物的特定具体实例的关于纵轴旋转约90度的第二侧视图;

[0030] 图15为以复数个可植入零件形式产生的图10中所示的骶髂关节植入物的具体实例的侧视图;

[0031]图16为贯穿骶髂关节的横截面图,其说明植入骶髂关节植入物的一具体实例的方法,步骤包括将针插入骶髂关节的关节平面中以注射放射照相染料以允许荧光观测骶髂

-U.-K-

夫.ρ ;

[0032]图17为贯穿骶髂关节的横截面图,其说明植入骶髂关节植入物的具体实例的方法,步骤包括将管状针以导线形式固定在骶髂关节内;

[0033]图18为贯穿骶髂关节的横截面图,其说明植入骶髂关节植入物的一具体实例的方法,步骤包括沿固定在骶髂关节中的针将管状探针的本体推进至在骶髂关节前部的固定位置;

[0034]图19为贯穿骶髂关节的横截面图,其说明植入骶髂关节植入物的一具体实例的方法,步骤包括沿固定在骶髂关节中的管状探针的本体推进组织扩张器以允许与骶骨及髂骨的表面相抵地置放套管来暴露骶髂关节;

[0035] 图20Α为骨盆区域的后视图,其展示内部已插入有套管对准夹具的套管相对于骶髂关节的固定置放;

[0036] 图20Β为具有十字丝(cross hair)的图20A中所示的套管夹具插入物的透视图;

[0037] 图20C为内部插入有套管对准夹具的图20B中所示的套管的透视图,该套管对准夹具具有可对准的十字丝;

[0038] 图21A为骨盆区域的后视图,其展示内部具有第一钻头夹的套管相对于骶髂关节的固定置放;

[0039] 图2IB为内部具有第一钻头夹的图2IA的套管的透视图;

[0040]图22为贯穿骶髂关节的横截面图,其说明植入固着融合植入物的一具体实例的方法,步骤包括用接收管状钻的第一钻头夹置换组织扩张器以产生实质上沿骶髂关节的关节平面的第一钻孔;

[0041]图23为贯穿骶髂关节的横截面图,其说明植入髂植入物的一具体实例的方法,步骤包括用第二钻头夹置换第一钻头夹,该第二钻头夹允许相对于第一钻孔产生各自实质上沿骶髂关节的关节平面的额外钻孔;

[0042]图24为贯穿骶髂关节的横截面图,其说明植入固着融合植入物的一具体实例的方法,步骤包括用髓针夹置换第二钻头夹(或视方法而定,第一钻头夹),该髓针夹接收可推进入骶髂关节中以产生植入物接收间隙的管状髓针;

[0043] 图25为骨盆区域的侧视图,其展示定位在骶髂关节的尾侧关节面(用断线显示)之间的骶髂关节植入物的一具体实例;

[0044]图26A提供骶髂关节的剖视图,其展示固着融合植入物的一特定具体实例在藉由图16-24中说明的方法产生的植入物接收间隙中的置放;

[0045] 图26B为图26A的一部分的放大视图,其展示固着融合植入物的一特定具体实例在藉由图16-24中说明的方法产生的植入物接收间隙中的置放;

[0046] 图26C为图26B中所示的横截面图26C-26C,其展示藉由图16-25中说明的方法产生的植入物接收间隙及植入其中的固着融合植入物的一特定具体实例的组态;

[0047] 图27提供骨盆的侧视图,其展示定位在骶髂关节的关节平面内的前侧关节面(用断线显示)之间的髂植入物的一具体实例;

[0048]图28A提供骶髂关节的剖视图,其展示固着融合植入物的一特定具体实例在藉由图16-24中说明的方法产生的植入物接收间隙中的置放;

[0049] 图28B为图26A的一部分的放大视图,其展示固着融合植入物的一特定具体实例在藉由图16-24中说明的方法产生的植入物接收间隙中的置放;

[0050] 图28C为图28B中所示的横截面图28C-28C,其展示藉由图16-24中说明的方法产生的植入物接收间隙及植入其中的固着融合植入物的一特定具体实例的组态;

[0051]图29提供骨盆的侧视图,其中固着融合植入物的一具体实例实质上定位在前侧关节面与尾侧关节面(用断线显示)之间且在有限程度上安置在骶髂关节的关节外;

[0052] 图30提供骨盆的侧视图,其中固着融合植入物的一具体实例定位于骶髂关节的关节平面内前侧关节面与尾侧关节面(用断线显示)之间;

[0053]图31为贯穿骶髂关节的横截面图,其说明可与植入的骶髂关节植入物附接的使狭长部件对准以穿过骶髂关节植入物的对准工具;

[0054]图32为贯穿骶髂关节的横截面图,其说明与植入的骶髂关节植入物的第一端接合的耦接组件;

[0055] 图33为骨盆区域的后视图,其展示与一对相应耦接组件接合的悬跨部件(spanning member),该等親接组件相应地与一对植入的骶髂关节植入物的第一端接合;

[0056]图34为骨盆区域的后视图,其展示与一对相应耦接组件接合的悬跨部件,该等耦接组件相应地与植入的骶髂关节植入物接合且直接与骶骨啮合。

具体实施方式

[0057] 一般而言,本发明系关于一种骶髂关节固着融合系统,其提供一种固着且融合骶髂关节的方法及一种在置放于骶髂关节的关节区域内时有助于骶髂关节的稳定性及融合的骶髂关节植入物。

[0058] 现在主要参考图1,其展示用于固着骶髂关节(I)的一种常用现有方法及器件。所示现有器件包含一或多个实质上线性的狭长部件(2),其可插入于相应尺寸的经髂骨孔

(3)中,其中第一部分延伸入骶骨⑷的骨中且第二部分延伸入髂骨(5)的骨中,藉此跨越骶髂关节(I)延伸。呈经髂骨置放的一或多个实质上线性的狭长部件(2)(其可组态成可进一步包括一定量的锥度或进一步包括螺旋螺纹(spiral thread)的与外表面親接的圆柱状杆以避免需要产生经髂骨孔)可相对于骶骨(4)呈固定关系地定位髂骨(5)。然而,此等实质上线性的狭长部件(2)的此经髂骨置放可具有上述缺点。另外,经髂骨孔(3)及狭长部件

(2)的现有置放可在由骶髂关节(I)的成对关节面(16)(亦通常称为「耳状面(auricularsurface)」)的边界界定的彼区域的外部,如以下进一步描述。

[0059] 现在主要参考图2-6,展示本发明骶髂关节植入物¢)的一具体实例,其可部分地包括具有纵轴(8)的狭长本体(7)。狭长本体(7)可具有尺寸足以避免在相对于骶骨(4)外科置放及固着髂骨(5)的正常力量下变形的组态。因此,尽管图2-6中所示的骶髂关节植入物¢)的具体实例可为大体上圆柱状或横截面为圆形;但本发明不如此受限制,且狭长本体(X)可具有与下文描述的方法一致的众多及变化的横截面组态中的任一者,诸如椭圆形、三角形、矩形、正方形、菱形或其类似组态。作为一非限制性实例,视应用而定,图2中所示的大体上圆柱状的狭长本体(7)可具有在约0.5公分(「cm」)至约Icm的范围内的直径及安置在第一植入物端(11)与第二端(12)之间的在约3cm与约6cm的范围内的长度。

[0060] 关于本发明的特定具体实例,狭长本体(7)可进一步包括定界在狭长本体(7)的第一植入物端(11)与第二植入物端(12)之间连通的轴向路径(10)的轴孔(9)。轴孔(9)允许在轴向路径(10)内置放导销(13)(或其它导引部件),可围绕该导销导引骶髂关节植入物(6)的具体实例以插入及置放在骶髂关节(I)中,如以下进一步描述。

[0061] 再次主要参考图2-6,骶髂关节植入物¢)的具体实例可进一步包括与狭长本体

(7)的外表面耦接的大体上沿纵轴(8)向外径向延伸的第一径向部件(14)。关于如图中所示的骶髂关节植入物¢)的某些具体实例,第一径向部件(14)可沿纵轴(8)在实质上狭长本体⑵的整个长度上延伸;然而,本发明不如此受限制,且本发明骶髂关节植入物(6)的具体实例可具有第一径向部件(14),其可部分地或以复数个不连续部分形式沿纵轴(8)或狭长本体(7)延伸。

[0062] 再次参考图2-6,骶髂关节植入物¢)的具体实例可进一步包括第二径向部件

(15) ο第一径向部件(14)及第二径向部件(15)的每一者可大体上以相反关系(围绕狭长本体⑵的纵轴⑶分开约180度)自狭长本体(7)径向向外延伸;然而,本发明不如此受限制,且第一径向部件(14)及第二径向部件(15)可围绕狭长本体(7)间隔较大或较小度数。可使第一径向部件(14)或第二径向部件(15)的每一者(或两者)的组态适于非横向定位在骶髂关节(I)的关节面(16)之间来以实质上不动、不动或固定关系安置骶骨(4)及髂骨(5)。如本文所用的术语「非横向(non-transversely)」意谓不布放或延伸跨越骶骨

(4)与髂骨(5)之间的关节且特定言的不包括骶髂关节植入物的如上所述且展示于图1中的经髂骨置放。术语「关节面(articular surface)」包括在骶骨(4)及髂骨(5)的表面之间形成的两对L形表面,其具有如例如图25、27及29中所示的前侧部分(87)及尾侧部分

(86)(断线),且如本文所用,该术语不包括骶骨(4)或髂骨(5)的在关节面(16)的外部的结构或区域,诸如配对髂骨粗隆(iliac tuberosity)及骶骨窝(sacral fossa) ο

[0063] 第一径向部件(14)及第二径向部件(15)的每一者可各自提供分开一厚度(19Α)而安置且具有由顶部边缘(20)、一对侧边缘(21) (22)及底部边缘(23)定界的区域的一对相反面(17) (18)。侧边缘对的第一者(21)可如上所述与狭长本体(7)连接,从而使第二侧边缘(22)自狭长本体(7)的纵轴(8)向外一距离地定位。作为一非限制性实例,第一径向部件(14)及第二径向部件(15)的每一者可实质上呈矩形组态,其在侧边缘对的第一者

(21)与侧边缘对的第二者(22)之间的高度(28a)在约0.2cm与约Icm的范围内。可理解地,直径较小的狭长本体(7)可包括具有较大高度(28a)的第一径向部件(14)及第二径向部件(15)(或其它径向部件),且直径较大的狭长本体(7)可需要具有较小高度(28a)的第一径向部件(14)及第二径向部件(15)(或其它径向部件)。

[0064] 第一径向部件(14)及第二径向部件(15)的每一者的顶部边缘(20)可实质上与狭长本体(7)的第一植入物端(11)对准地终止。第一径向部件(14)及第二径向部件(15)的底部边缘(23)可实质上与狭长本体(7)的第二植入物端(12)对准地终止。关于某些具体实例,底部边缘(23)可进一步包括角式组件(24),其自狭长本体(7)向外向第一植入物端(11)倾斜一距离、在第二植入物端(12)处开始且接合侧边缘对的第二者(22)。角式组件(24)可具有相对于纵轴(8)的垂线的在约15度至约30度范围内的角度(25),如图2中所示;然而,本发明不如此受限制且角式组件(24)可为半径组件、锥形组件或使插入骶髂关节(I)中容易的其它组件。

[0065] 再次主要参考图2-6,骶髂关节植入物¢)的某些具体实例可进一步包括沿该狭长本体(7)的纵轴(8)延伸的适于延伸入髂骨(5)的皮质骨中的第三径向部件(26)。某些具体实例可进一步包括沿该狭长本体(7)的纵轴(8)延伸的适于延伸入该骶骨(4)的皮质骨中的第四径向部件(27)。可使第三径向部件(26)及第四径向部件(27)的某些具体实例适于分别延伸入骶骨(4)及髂骨(5)的骨中。

[0066] 关于图3中所示的骶髂关节植入物(6)的非限制性具体实例,第三径向部件(26)及第四径向部件(27)可大体上与狭长本体(7)的纵轴(8)成直线地连接。第三径向部件

(26)及第四径向部件(27)的每一者可实质上与第一径向部件(14)及第二径向部件(15)呈相反关系(分开约180度)及呈垂直关系(约90度)自狭长本体(7)向外径向延伸(亦参见图8及9C);然而,本发明不如此受限制,且第三径向部件(26)及第四径向部件(27)(若具体实例包括第四径向部件(27))可围绕狭长本体(7)相对于彼此及相对于第一径向部件(14)及第二径向部件(15)间隔较大或较小度数,视应用及与骶骨⑷或髂骨(5)的骨的所要的啮合量而定。

[0067] 第三径向部件(26)或第四径向部件(27)的每一者的组态可根据需要变化以提供足以促进实质性不动、不动的可与骶骨(4)及髂骨(5)的骨啮合的一定量的表面积,或在植入骶髂关节植入物(6)时相对于髂骨(5)固定骶骨(4)及进一步提供对骶髂关节植入物(6)在由骶髂关节(I)的肢接表面(16)定界的区域内的植入物位置处的旋转或其它不合需要移动的阻力。因此,骶髂关节植入物¢)的具有第三径向部件(26)及第四径向部件

(27)的具体实例可提供以分开一厚度(19b)安置的一对相反面(17) (18)且具有由顶部边缘(20)、一对侧边缘(21) (22)及底部边缘(23)以与以上关于第一径向部件(14)及第二径向部件(15)所述类似的组态定界的区域。侧边缘对的第一者(21)可如上所述与狭长本体(7)连接,从而使第二侧边缘(22)自狭长本体(7)的纵轴(8)向外一距离定位。作为一非限制性实例,第三径向部件(26)及第四径向部件(27)的每一者可具有实质上矩形组态,其在侧边缘对的第一者(21)与侧边缘对的第二者(22)之间的高度(28b)在约0.1cm与约0.4cm的范围内。第三径向部件(26)及第四径向部件(27)的每一者的顶部边缘(20)可实质上与狭长本体(7)的第一植入物端(11)对准地终止。第三径向部件(26)及第四径向部件(27)的底部边缘(23)可实质上与狭长本体(7)的第二植入物端(12)对准地终止。关于某些具体实例,第三径向部件(26)及第四径向部件(27)的底部边缘(23)可进一步包括角式组件(24),其使侧边缘对的第二者(22)向狭长本体(7)的第一植入物端(11)弯曲。角式组件(24)可具有相对于纵轴(8)的垂线的在约15度至约30度范围内的角度(25);然而,本发明不如此受限制且就本发明的某些具体实例而言,可能无角式组件(24)或角式组件的角度可大于或小于约15度至约30度的范围内的角度。另外,角式组件(24)可与图中所示类似或在特定骶髂关节植入物¢)的径向部件之间可不类似(视应用而定)。

[0068] 再次主要参考图2-6,且不限于前述,第三径向部件(26)及第四径向部件(27)可具有小于第一径向部件(14)及第二径向部件(15)的高度(28b)。尽管第三径向部件(26)及第四径向部件(27)的结构似乎与第一径向部件(14)及第二径向部件(15)类似,但功能可实质上不同。第一径向部件(14)及第二径向部件(15)具有一组态(高度、长度、厚度、表面积、及相对于狭长本体(7)的外表面的位置,如上所述),其能够或允许非横向置放在关节面(16)之间(且不跨越)或在如以下进一步描述用手术藉由移除骶髂关节(I)的一部分在由关节面(16)定界的区域内产生的植入物接收间隙(29)内,在置放于关节面(16)之间或植入物接收间隙(29)内时能够使骶髂关节(I)实质上不动或不动。

[0069] 相对比地,第三径向部件(26)及关于具有第四径向部件(27)的彼等具体实例可具有一组态(高度、长度、厚度、表面积、及在狭长本体(7)的外表面上的位置,如上所述),其能够在非横向定位骶髂关节植入物(6)于骶髂关节⑴的关节面(16)之间时被强制推动入骶骨(4)或髂骨(5)的皮质骨或疏松骨中一定深度或被置放在植入物接收间隙(29)的径向部件接收通道(74)内。第三径向部件(26)及第四径向部件(27)的高度可足以对抗植入的骶髂关节植入物(6)的旋转以允许疏松骨骨融合于髂植入物(6)或穿过与第一径向部件(14)及第二径向部件(15)类似的第三径向部件(26)或第四径向部件(27)或两者的孔隙。现在主要参考图2,自狭长本体(7)向外延伸的每一径向部件(14) (15) (26) (27)可终止于相对于径向部件的表面实质上垂直安置的径向部件隔条(98)。

[0070] 再次主要参考图2-6,骶髂关节植入物¢)的特定具体实例可进一步包括一或多个孔隙组件(31),其在第一径向部件(14)或第二径向部件(15)或两者的相反面(17) (18)之间连通。孔隙组件(31)的开口间隙的量可由可具有众多及变化的组态的孔隙周边(32)界定,该等组态的尺寸足以允许髂骨(5)或骶骨(4)(或两者)的表面邻近于骶髂关节植入物(6)的第一径向部件(14)或第二径向部件(15)(或两者)以向孔隙组件(31)中或穿过孔隙组件(31)生长一定距离或在孔隙组件(31)内融合或融合入置放在孔隙组件内的材料,该材料可包括:可骨整合、骨诱导性、骨传导性、成骨材料或生物活性剂、或其组合及排列。作为一非限制性实例,孔隙周边(32)可通常具有椭圆形组态,从而产生位于第一径向部件(14)或第二径向部件(15)(或两者)中(或视具体实例而定位于其它径向部件中)的椭圆形孔隙组件(31),其中椭圆形孔隙组件(31)的长度与第一径向部件(14)或第二径向部件(15)的长度对准且为径向部件的长度的约四分的一至约三分的二,且椭圆形孔隙组件(31)的宽度定位于第一径向部件(14)或第二径向部件(15)的侧面(21) (22)之间且为高度(28a)的约四分的一至约三分的二。另外,狭长本体(7)可进一步包括孔隙组件(31),其在径向部件(14) (15) (26) (27)之间在外表面之间连通。

[0071] 再次主要参考图2-7,骶髂关节植入物¢)的具体实例可进一步包括与狭长本体

(7)的第一植入物端(11)耦接的抗迀移组件(33)。抗迀移组件(33)可采用狭长本体(7)的第一端的增大末端部分的形式(如图2-6中所示),一或多个径向部件的高度(28)增加(诸如如图7中所示向外张口)邻近狭长本体(7)的第一植入物端(11)。作为一非限制性实例,抗迀移组件(33)可采用具有大体上圆形组态的端帽(34)的形式,其中中心实质上与狭长部件(7)的纵轴(8)对准且径向向外延伸一足够距离以防止在植入物接收间隙(29)中进行植入之后,骶髂关节植入物¢)的第二植入物端(12)前进而进一步进入骶髂关节(I)中。尽管所示端帽(34)大体上为圆形组态,但端帽(34)可具有界定适用于固定骶髂关节植入物(6)相对于骶髂关节(I)的位置的椭圆形、正方形、矩形或其它组态的端帽周边

(35) ο另外,抗迀移组件(33)可具有足以进一步包括一或多个孔(36)的尺寸,该等孔在抗迀移组件(33)的相反表面(37) (38)之间连通且经定尺寸以接收可经驱动或旋转以使机械扣件的一部分与骶骨(4)或髂骨(5)啮合的机械扣件(39)(诸如有螺纹部件、有缺口部件、锁定部件或其类似物)。现在主要参考图2,抗迀移组件(33)亦可采用在一部分或全部外表面上的锥形组件的形式,该等锥形组件自表面向外渐尖,从而允许插入骶髂关节植入物(6)的具体实例但对抗反向行进。现在主要参考图7,抗迀移组件(33)可采用骶髂关节植入物

(6)的锥形末端(33/99)的形式,该锥形末端阻止骶髂关节植入物(6)的正向或反向行进。

[0072] 上述狭长本体(7)以及骶髂关节植入物(6)的其它组件可自复数件或呈单一件形式的尺寸适合粒子、薄片或其它结构形式的生物兼容材料或生物兼容及可生物降解材料的组合、或经适合黏合或成形或模制以提供根据本发明的组态的可成形或可模制材料制造或形成。

[0073] 现在主要参考图8及9,骶髂关节植入物¢)的具体实例可进一步包括耦接、产生或整合于骶髂关节植入物¢)的所有或一部分外表面的涂层(40)。涂层(40)可为可与骶髂关节植入物(6)耦接的能够与髂骨(5)及骶骨(4)的骨进行生物兼容骨整合的任何组成物,诸如纯氧化铝、二氧化钛、羟基磷灰石、三磷酸钙或其类似物。作为一非限制性实例,涂层(40)可藉由用电浆炬、电浆调变器或电浆枪进行电浆喷射来涂覆。或者,涂层(40)可藉由喷砂、珠粒喷击、模制或其类似操作产生骶髂关节植入物¢)的表面粗糙度、孔隙率或不规则性来达成。涂层(40)可具有在约40μπι与约ΙΟΟμπι的范围内的厚度。此外,骶髂关节植入物(6)的具体实例可组态成具有贯穿的互连孔的材料,诸如可购自Zi_er (P.0.Box708,1800 West Center Street, Warsaw, Indiana46581-0708)的 TRABECULAR METAL ;或金属发泡体,诸如可购自 Nat1nal Research Council Canada(1200 Montreal Road, Bldg.M-58,Ottawa, Ontar1, Canada)的钛发泡体;或经完全工程改造的多孔钛结构,诸如可购自 Tecomet(115 Eames Street, Wilmington, MA 01887)的 TRABECULITE。

[0074] 再次主要参考图2及图3-6,本发明的具体实例可进一步包括一或多种生物活性剂(41),其可直接施用于骶髂关节植入物(6)的外表面或可与可施用于骶髂关节植入物

(6)的外表面或另外组成骶髂关节植入物的一部分的生物相容材料或生物相容可生物降解材料或生物兼容可骨整合材料(共同用数字指针(100)表示)混合。关于固着融合植入物

(6)的特定具体实例,生物活性剂(41)可与一定量的生物兼容可生物降解材料或可骨整合材料(100)混合且定位于一或多个孔隙组件(31)内。

[0075]出于本发明的目的的「生物兼容」意谓任何材料执行本发明的具体实例的预定功能而不引发对接受者的任何非所要局部或全身性影响的能力,且可包括非可生物降解材料,诸如:陶瓷、金属或钢(诸如钛合金)或硬质聚合材料或硬质层压材料或复合物(其包括分散在硬质层压材料内的尺寸适合的金属粒子或钢粒子)、经适合黏合或成形以提供组态的生物兼容材料的适合大小的粒子、聚胺基甲酸酯、聚异丁烯、乙烯-α-烯烃共聚物、丙烯酸聚合物及共聚物、乙烯基卤化物聚合物及共聚物、聚乙烯酯、聚氯亚乙烯、聚丙烯腈、聚乙烯酮、聚乙烯芳族化合物(诸如聚苯乙烯)、乙烯系单体与烯烃的共聚物(诸如乙烯-甲基丙烯酸甲酯共聚物)、丙烯腈-苯乙烯共聚物、ABS树脂、乙烯-乙酸乙烯酯共聚物、聚酰胺(诸如耐纶66(Nylon 66)及聚己内酯)、醇酸树脂、聚碳酸酯、聚氧化乙烯、聚酰亚胺、聚醋、环氧树脂、嫘萦-三乙酸醋、塞璐芬(cellophane)、聚醚醚酮(PEEK)、聚醚酮酮(PEKK)、可购自 Istituto di Scienza e Tecnologia dei Mareriali Ceramici (Faenza, Italy)的来自木料的骨(bone-from-wood)、或其类似物;或可生物降解材料,如本文所述。

[0076] 出于本发明的目的的「可生物降解」意谓任何生物兼容材料在骶髂关节的生理环境内藉由一或多个物理、化学或细胞过程以符合以可藉由选择聚合物或聚合物的混合物(亦称为聚合材料)控制的治疗含量提供骶髂关节病状的治疗的速率分解的能力,包括(但不限于):聚乳酸交酯聚合物(PLA)、乳酸与乙醇酸的共聚物(PLGA)、聚乳酸-聚氧化乙烯共聚物、聚(ε -己内酯-共-L-乳酸)(PCL-LA)、甘胺酸/PLA共聚物、涉及聚氧化乙烯(PEO)的PLA共聚物、乙酰化聚乙烯醇(PVA)/聚己内酯共聚物、羟基丁酸酯-羟基戊酸酯共聚物、聚酯(诸如(但不限于)天冬胺酸及不同脂族二醇)、聚(酒石酸烷二酯)及其与聚胺基甲酸酯的共聚物、具有各种酯内含物及具有化学或酶促可降解键的聚麸胺酸酯、其它可生物降解非肽聚酰胺、胺基酸聚合物、聚酸酐药物载体(诸如(但不限于)聚(癸二酸)(PSA)、脂族-芳族均聚物及聚(酸酐-共-酰亚胺)、藉由基质或侧位传递系统的聚(磷酸酯)、聚(磷氮烯)、聚(亚胺基碳酸酯)、交联聚(原酸酯)、羟基化聚酯-胺基甲酸酯、或其类似物。

[0077] 出于本发明的目的的「生物活性剂」意谓种类或量可变化以提供有效介导骨、软骨、腱的形成或愈合,或降低、抑制或防止在骶髂关节(I)内置放固着融合植入物的一具体实例之后出现骶髂关节病状的症状(诸如感染或疼痛)的治疗含量的彼等药剂或药剂混合物,且可不加限制地包括影响骨生长的药剂、去矿化骨基质、干细胞、同种异体移植物、自体移植物、异种移植物、成骨蛋白(无论天然存在、合成或重组)、生长因子、细胞激素、骨形态发生蛋白2、骨形态发生蛋白7、止痛剂、麻醉剂、消炎剂、抗细菌剂、抗病毒剂、抗真(naproXerors^^u^^^H(lid〇cainer>hss(cannabinoidr^料麵逢(酿哲顧虜獅»(ampho teri c in)r^iil^Kialbn>#(酿哲 N* 渐到彦 Zi 爆薛(anecortaveacetate)) Λ^+5»(retinoid)(酿哲彦HfL^s'TI (tsarotene)r^MM0 誇逢(酿哲 211 Zi 驛itsms;sl H (21-acet〇xypregnenol〇ne) y¾*^¾(alclometasone) y¾¾'¾!¾ (algestoner^a渐 _ (旨。i§niQ-0r^«^^(beclomethasonersfe^^¾(betamethasone) >身薛渐_ (budesonide) - 00 ^¾(ChlOrOPredniSOne) Λ«φ彦Mt(ClObetaSOl) Λρϊφ#,¾(ClObetaSOne) Λ«^ft^(ClOCOrtOlOne) >«錄^到音(cloprednolr^Mif (corticoster§er^stI>>(c〇rtis§er^sl^®(cortivazolr薛>fr^T#egfpsacort) N 薛渐_ (hgg§lQ-g) y 张游沐疼(desoximetasone) y 薛»沐¾(dexamethasone) y ΗΜϋ^(dif lorasone) y HM绅(dif lucortolone) y^n®mcv(^i^psdnate) y^姻务爆(enoxolone) yMiL^# S 仁 sacort) y 0(flucloronide) y¾*^¾(f lumethasone) y 猶/¾ 識疼(f lunisolide) y*¾¾;¾¾^(f luocinolone acetoniderMa渐 _ (f luocin〇nider»o*TMmcv(f^〇8rtin butylrM^T 绅(f lu〇c〇rt〇l〇ne) y 騎沐^(f lu〇r〇meth〇l〇ne) yMnth^ziMfe(f luperoloneacetater»錄^n沛 ZiMfe(f luprednidene acetater»錄/¾¾ (f luprednisoloner騎興識¾(f lurandrenol ideralM»瞒^¾(fluticasone prop1naterfn減到彦(formocortalr^a渐 _ (halcinonider«{n^^MtalMfe(halobetasol prop1nater¾^¾(halometasone) y 现錄^^21 爆薛(halopredone acetate) y 興^彦蹈雕(hydrocortamater興兩¾!¾ (hydrocortisoner»^'^®(loteprednol etabonaterJp0 ^ |画(mazipredone) y ,¾¾¾(medrysone) Z.錄^0 (meprednisone) y ,錄^n^(methylprednisolone) yM^^)ss.Mfe(mometasone furoate) Λ^ί^^¾(ParamethaSOne)^^^n^®mcv(PSdniCarbate) ym^BM (prednisolone) '^¾;¾ 251 HzitM薄SI ZiMi^^^n^s爆蜜(prednisolone sodium phosphater錄¾¾(prednisoner(prednivalr錄 ZSizl 沛(psdnylidener^#Mt^ (rimexol§er_^s¾(tixocortolrs^a^(triamcinoloners^^ri(triamcinolone acetonider讲苗^渐_ (triamcinolone benetoniderps^^ri(triamcinolone hexacetonide)r§?_掛部|^]麵-8凿諸證^^袖矣雜®凿諸 SM(酿哲到瑟gNuvasive^^(7475 Lusk

13Blvd.,San Diego, CA 92121 USA)的OSTEOCEL PLUS)、及任何其衍生物(以单独或以其组合形式)。

[0078] 关于本发明固着融合植入物(6)的特定具体实例,生物活性剂(41)可贯穿生物相容或生物相容可生物降解材料(或生物兼容材料的混合物或生物兼容可生物降解可生物降解材料的混合物)分散,此系藉由将生物活性剂(41)混合入熔融的生物兼容或生物可降解聚合物中且接着藉由冷却使所得材料凝固,从而使生物活性剂(41)实质上均一地分散于每一处来达成。可生物降解材料或生物兼容材料或其混合物可经选择以具有低于生物活性剂(41)变为反应性或降解的温度的熔点。或者,可藉由溶剂浇铸而使生物活性剂(41)分散在生物相容或可生物降解材料中每一处,在溶剂浇铸中,生物相容或可生物降解材料溶解于溶剂中,且生物活性剂(41)溶解或分散于溶液中。接着蒸发溶剂,从而使生物活性剂(41)留在生物相容或可生物降解材料的基质中。溶剂浇铸需要生物兼容或可生物降解材料可溶于有机溶剂中。或者,固着融合植入物(6)可置放于溶解有一定浓度的生物活性剂(41)的溶剂中且其中位于孔隙组件中或施用于外表面的固着融合植入物(6)或生物相容或生物相容可生物降解材料会膨胀。固着融合植入物(6)或其部分的膨胀会吸引一定量的生物活性剂(41)。可接着蒸发溶剂,从而使生物活性剂(41)留在生物相容或生物相容可生物降解材料内。关于使生物活性剂(41)贯穿固着融合植入物¢)的或与固着融合植入物耦接的生物相容或可生物降解生物兼容材料分散的每一方法,治疗含量的生物活性剂

(41)可包括在生物相容可生物降解材料中以向骶髂关节(I)提供治疗有效含量的生物活性剂以治疗特定骶髂关节病状。

[0079] 其它非活性剂(42)可出于多种目的包括在生物相容可生物降解材料中。举例而言,可采用缓冲剂及防腐剂。可使用的防腐剂包括(但不限于)亚硫酸氢钠、硫酸氢钠、硫代硫酸钠、氯化苯甲烃铵、氯丁醇、硫柳汞、乙酸苯汞、硝酸苯汞、对羟基苯甲酸甲酯、聚乙烯醇及苯基乙醇。可采用的缓冲剂的实例包括(但不限于)如由FDA或美国或外国的其它适当机构针对所要投药途径所核准的碳酸钠、硼酸钠、磷酸钠、乙酸钠、碳酸氢钠及其类似物。诸如氯化钠及氯化钾的电解质亦可包括在调配物中。

[0080] 作为一非限制性实例,具有含用于治疗骶髂关节⑴的生物活性剂(41)的生物兼容可生物降解部分的固着融合植入物¢)的具体实例可藉由将生物活性剂(41)分散于如上所述的生物兼容可生物降解材料中以提供在治疗含量下的生物活性剂(41)释放特性来制备。如下所述在骶髂关节⑴中植入固着融合植入物(6)时,固着融合植入物(6)的生物兼容可生物降解部分可实质上连续释放生物活性剂(41)以在约I毫克至约4毫克的治疗含量下提供局部量的骨形态发生蛋白2以有助于骨再生长。应了解提供传递一定量的骨形态发生蛋白2以有助于骨再生长的固着融合植入物(6)的一具体实例的此特定实例不意欲具有限制性,且固着融合植入物¢)的具体实例可用于传递呈个别或组合形式的众多及变化的活性剂(41)以在植入固着融合植入物(6)的具体实例之后治疗骶髂关节⑴的广泛范围的病状。

[0081] 现在主要参考图10-15及30,本发明的特定具体实例可进一步在固着融合植入物

(6)的第一植入物端(11)与第二植入物端(12)之间包括一定量的弯度(43)。弯度(43)的量可在固着融合植入物¢)的具体实例与具体实例之间变化,视在实质上线性狭长本体

(7)之间的应用而定,该狭长本体系如上所述以包括一定量的弯度(43),其界定有助于在骶髂关节(I)的关节面(16)之间的前侧部分(87)及尾侧部分(86)中或在相应植入物接收间隙(29)中进行置放的半径。作为一非限制性具体实例,半径可在约2cm及约6cm的范围内。

[0082] 现在主要参考图15,具有一定量的弯度的本发明的某些具体实例可以复数个植入物区段(101) (102) (103)提供,该等区段可藉由下述方法个别地植入如图25、27或29中所示的关节区域(44)内。

[0083] 另外,骶髂关节植入物(6)的具体实例可经组态以收容骨生长刺激器(105)。适用的可植入生长刺激器可直接啮合电池组的阳极及在骶髂关节植入物¢)内或极邻近骶髂关节植入物处植入的单一或双重钛阴极导线。阴极导线可向宿主骨、骨移植物或器件的部分中安置一定距离,较佳使阴极端接触活骨及/或锚定入活骨中。本发明的具体实例可包括具有隔热材料(诸如PEEK)以防止阴极-金属接触,同时允许阴极-骨接触的金属植入物。电池组可置放于筋膜外皮下袋中以达成可移除的置放。适合生长刺激器可购自B1metTraumalOO Interpace Pkwy#l(Parsippany, NJ 07054-1149)。

[0084] 可理解地,无论单独或呈接合关系、无论为相同或不同具体实例的复数个本发明骶髂关节植入物(6)可与本文关于固着且融合骶髂关节(I)所述的现有或本发明植入方法一起加以利用。作为一实例,复数个狭长本体(7)可以固定、实质上固定或可移动关系接合以提供骶髂关节植入物(6)的一具体实例。

[0085] 现在主要参考图16-24,其为接近骶髂关节(I)的肢接表面(16)之间的关节区域

(44)且在骶髂关节(I)的关节区域(44)内的肢接表面(16)之间非横向置放骶髂关节植入物(6)以藉由骶髂关节(I)的肢接表面(16)对骶髂关节植入物¢)的相应啮合来以实质上不动关系安置骶骨(4)及髂骨(5)的一非限制性方法。所述方法的特定实例足以使一般技术者能够利用骶髂关节植入物¢)的具体实例且不意欲关于步骤顺序,或使用所有或任何步骤或将一或多个步骤组合成为单一步骤,或进行作为子步骤的任一步骤、或其它类似等效或现有步骤以将骶髂关节植入物的具体实例植入骶髂关节(I)内而具有限制性。

[0086] 现在主要参考图16,方法的一具体实例可包括使在镇静状态下的患者伏卧在半透明手术台(或其它适合表面)上的步骤。骶髂关节(I)可经局部麻醉以允许在荧光检查指导下将射线照相对比剂(46)(作为一非限制性实例,Isoview 300射线照相对比剂)注射入骶髂关节⑴之下路态样中以描绘骶髂关节⑴的关节面(16)的轮廓。在骶髂关节(I)内注射射线照相对比剂(46)可利用具有可在骶髂关节(I)的肢接表面(16)之间前进的第一管状部件端(48)且具有以可移除方式与套节(50)耦接的第二管状部件端(49)的管状部件(47)(诸如注射针)达成。套节(50)可经组态以按可移除方式与注射筒(51)(或欲含有且传递一定量的射线照相对比剂(46)的其它器件)耦接。在注射筒(51)的实例中,注射筒(51)可具有能够接收足以描绘骶髂关节(I)的侧关节面(16)的轮廓的一定量的射线照相对比剂(46)的内容积。柱塞(52)可以滑动方式接收于筒(51)内以穿过管状部件

(47)将射线照相对比剂(46)传递入骶髂关节(I)中。管状部件(47)可具有在约第16型号及约第20型号的范围内的型号且可进一步在外表面上以增加方式标记以允许确定第一针端(48)已在骶髂关节⑴内前进的深度。当第一针端(48)前进入骶髂关节⑴中时,放射照相染料(46)可自注射筒(51)内传递入骶髂关节⑴中以允许观测骶髂关节⑴及在骶髂关节(I)内定位管状针(47)。

[0087] 现在主要参考图17,一旦第一管状部件端(48)已经充分推进入骶髂关节(I)中且骶髂关节(I)的关节面(16)已经充分观测,就可自管状部件(47)移除套节(50),从而使管状部件(47)固定在骶髂关节(I)内以作为随后用于在骶髂关节(I)的肢接表面(16)之间非横向定位或置放骶髂关节植入物(6)或移除由关节面(16)界定的区域内的骶髂关节(I)的一部分以产生植入物接收间隙(29)的工具的初始导件。或者,一或多个导销(13)可沿管状部件(47)的实质上相同路径插入以达成骶髂关节(I)内的固定啮合且在随后步骤中用作导件。

[0088] 现在主要参考图18,可在骶髂关节(I)之后上路(或关于某些具体实例为下路)态样处的皮肤中产生小切口,其沿骶髂关节(I)的线在管状部件(47)的近端及远程延伸以提供接近骶髂关节(I)的肢接表面(16)之间的关节间间隙的孔道。管状探针(53)可与自骶髂关节(I)向外延伸的管状部件(47)(或导销(13))滑动啮合(尽管骶髂关节在图中出于说明目的可展示为实质上线性,但应了解骶髂关节的通常不规则特征未被移除)。管状探针(53)可具有大体上圆柱状的探针本体(54),其终止于在推进入骶髂关节(I)中的末端处的匙状尖端(55)。可移除管状探针柄(56)与探针本体(54)的相反端耦接。匙状尖端(55)可沿管状针(47)(或导线(13))经引导入骶髂关节(I)之后部中且在侧部荧光观测下经推进至骶髂关节(I)的前部。管状探针柄(56)可接着经移除,从而提供穿过在皮肤中产生的切口自骶髂关节⑴向外延伸的大体上圆柱状的探针本体(54)。

[0089] 现在主要参考图19,自切口至骶髂关节(I)的孔道可藉由将套管(57)插入切口中产生。具有平端(59)的软组织扩张器(58)或复数个尺寸递增的软组织扩张器可经探针本体(54)推进直至软组织扩张器(58)的平端(59)及相应套管端(45)接触骶髂关节(I)之后路态样。可自套管(57)内移除软组织扩张器(58)。套管(57)的外表面可与周围组织充分啮合以避免使组织位于套管(57)的中空内部。套管(57)的一非限制性具体实例提供具有实质上平行的相反侧壁的管状体,该等侧壁在复数个不同夹具可插入其中的两端(菱形)处以一半径终止。

[0090] 现在主要参考图20A-20C,套管对准夹具(60)可经探针本体(54)(或导销(13))推进且经接收在套管(57)内。实质上,相同十字丝¢3) (64)可安置在上夹具表面¢5)及下夹具表面¢6)上。十字丝¢3) ¢4)在X射线下与骶髂关节(I)的对准可证实套管(57)具有相对于骶髂关节(I)的成对关节面(16)的适当定向。可接着藉由将扣件穿过套管(57)置放入骶骨(4)或髂骨(5)中来使与成对关节面(16)呈适当定向的套管(57)与骶髂关节呈固定关系地安置。

[0091] 现在参考图21A及21B,第一钻头夹(67)可经探针本体(54)(或导销(13))推进且接收在套管(57)内。自骶髂关节(I)向外延伸的探针本体(54)(或导销(13))穿过第一钻头夹(67)的钻导孔(68)(或复数个导销(13)可穿过相应复数个导销孔(69)延伸)。钻导孔(68)可采用如图中所示的圆形孔、槽、或限制钻头(62)在钻头夹(60)内的移动且为钻头(62)提供相对于骶髂关节(I)的引导的其它组态的形式。

[0092] 现在参考图22,管状钻头(70)可经探针本体(54)及在第一钻头夹(67)的钻导孔

(68)内推进。在荧光检查引导下,管状钻头(70)可推进入骶髂关节(I)的肢接表面(16)之间的关节间区域(44)中以产生至经确定深度的第一孔(71)(用断线展示)。关于方法的某些具体实例,可移除来自骶髂关节(I)的关节面(16)之间的一定量的关节软骨或其它组织,该等关节面应足以允许植入骶髂关节植入物¢)的具体实例以置换移除的关节软骨或组织。因为方法移除骶髂关节(I)的关节面(16)之间的退化关节软骨或组织,所以骶髂关节(I)的关节面(16)可保持完整或实质上完整,从而允许在骶髂关节(I)的关节面(16)之间非横向定位骶髂关节植入物出)。可理解地,其它仪器可单独或与管状钻头¢2)组合利用来移除关节面(16)之间的关节软骨或组织,该等仪器诸如:起钉錾、圆头锉(bur)、孔锯、刮匙、激光器(诸如C02、钕/YAG (钇-铝-石榴石)、氩气及红宝石)、采用电磁能的电手术设备(切割电极可为精细显微针、柳叶刀、小刀、导线或带环、铉圈套器(snare)、通电手术刀(energized scalpel)或其类似物),其中传输的能量可为单极或双极的且以例如在约300kHz与约100kHz的范围内的高频电流操作,无论以「峰值因子(crest factor)」可恒定在每正弦波形约1.4且电压峰值为约300V以允许实现「纯」截割效应,同时具有可能的最小凝聚效应的纯正弦电流波形形式,或以峰值因子在1.5与8之间变化(其中递减峰值因子会提供较小凝聚效应)的调幅电流波形形式。可设置电手术波形以促进两种类型的组织效应,即凝聚(细胞内温度上升,接着该等细胞脱水且收缩)或切割(细胞水的加热快速发生以致细胞破裂)。凝聚的细胞与切割的细胞的比例可变化,从而产生「掺合」或「混合」效应。另外,完全整流电流、或部分整流电流、或产生较大量或侧向热量的闪耀电流可用于发现关节的关节面且帮助将探针或导线推进入肢接表面之间的位置中。此等电流可有效降解软骨且允许推进入关节中而不明显地穿透到软骨外很多。

[0093] 现在参考图23,关于本发明的某些具体实例,可自套管(57)内移除第一钻头夹

(67)且第二钻头夹(72)可经探针本体(54)推进且经接收在套管(57)内;然而,本发明不限于任何特定数目的钻头夹且关于方法的某些具体实例,第一钻头夹(67)可包括所有所需钻导孔(68)(或槽或钻导子的其它组态)且关于方法的其它具体实例,可以连续顺序利用复数个钻头夹以提供所有钻导孔(68)。关于由图展示的本发明的特定具体实例,第一钻头夹(67)可提供一或多个额外钻导孔(68),其相对于第一孔(71)引导具有相同或不同组态的第二或更多管状钻¢2)插入骶髂关节(I)内且推进入骶髂关节(I)中以在骶髂关节(I)内产生第二孔(73)(通常用断线以71/73显示)或以预定样式间隔开的复数个孔以允许自骶髂关节(I)的关节间间隙移除足够关节软骨(16)或其它组织以用于在由骶髂关节

(I)的成对关节面(16)界定且在其之间的区域内置放骶髂关节植入物(6)的具体实例。关于本发明的某些方法,可以连续顺序利用第一钻头夹(67)或第二钻头夹(72)或复数个钻头夹来移除骶髂关节(I)的一部分以产生植入物接收间隙(29)。就方法的此等具体实例而言,可自骶髂关节(I)的关节面(16)之间移除足以允许置放骶髂关节植入物(6)的某些具体实例的关节软骨或其它组织及足够软骨下骨,且一或多个径向部件接收通道(74)可切入该骶髂关节(I)的至少I个足以接收髂植入物(6)的其它具体实例的关节面(16)中。一或多个径向部件接收通道(74)可切入骶骨(4)或髂骨(5)的软骨下皮质骨或疏松骨中一定深度。

[0094] 现在主要参考图24,在随后步骤中,可自套管(57)内移除连续呈现的钻头夹(67)

(72)中的最后一个且髓针夹(75)可经探针本体(54)推进以定位在套管(57)内。髓针夹(75)可包括髓针导孔(76),其接收经探针本体(54)推进的管状髓针(78)的第一髓针端(77)。第一髓针端(77)可具有可推进入骶髂关节(I)中的组态。关于方法的某些具体实例,可使第一髓针端(77)适于自骶髂关节(I)的关节区域(44)内的关节面(16)之间移除一定量的关节软骨及其它组织以非横向置放具有狭长本体(7),或具有狭长本体(7)及第一径向部件(14),或具有在骶髂关节(I)的关节面(16)之间具有第一及第二径向部件(14) (15)的狭长本体(7)的骶髂关节植入物(6)。关于方法的其它具体实例,管状髓针

(78)可移除足够的一部分骶髂关节(I)以产生植入物接收间隙(29)来接收骶髂关节植入物(6)的具有狭长本体(7)、狭长本体(7)及至少I个适于在关节面(16)之间非横向置放的径向部件(14)或至少I个适于延伸入骶骨(4)或髂骨(5)的骨中的径向部件(26)的具体实例。作为一非限制性实例,图24展示髓针(78),其经组态以移除骶髂关节(I)的一部分来产生植入物接收间隙(29)以接收骶髂关节植入物(6)的具体实例,该等具体实例具有狭长本体(7)(第一径向部件(14)及第二径向部件(15)以适于定位在骶髂关节(I)的关节面(16)之间的实质上相反关系沿狭长本体(7)的纵轴(8)向其延伸)且进一步具有以适于相应延伸入骶骨(4)及髂骨(5)的骨中的实质上相反关系沿狭长部件(7)的纵轴(8)延伸的第三径向部件(26)及第四径向部件(27)。

[0095] 现在主要参考图25及26A、26B及26C,植入物接收间隙(29)及骶髂关节植入物(6)可经组态而具有相关尺寸关系,以使得在植入物接收间隙(29)内置放骶髂关节植入物

(6)会以实质上不动关系安置骶骨(4)及髂骨(5)且实质上避免骶骨(4)及髂骨(5)的位置关系自正常状态改变,或避免将骶骨(4)与髂骨(5)驱动到一起或分开而偏离或实质上偏离正常位置关系。选择骶髂关节植入物(6)及植入物接收间隙(29)的组态的意图是使骶骨(4)相对于髂骨(5)不动同时维持骶髂关节(I)呈实质上正常或实质上正常位置关系,或使骶髂关节(I)返回至实质上正常位置关系以矫正骶髂关节(I)的退化病状。

[0096] 作为一非限制性实例,植入物接收间隙(29)的组态允许骶髂关节植入物(6)的具体实例非横向置放于骶髂关节(I)的关节面(16)的尾侧部分(86)之间。尽管骶髂关节植入物(6)的某些具体实例可能仅提供定位于经相应组态的植入物接收间隙(29)内以啮合髂骨(5)的骨的至少一部分的狭长本体(7);但本发明不如此受限制,且可进一步包括至少第一径向部件或第一及第二径向部件,第一径向部件(14)的至少一部分外表面啮合骶骨

(4)及髂骨(5)的骨(73)的一部分。关于骶髂关节植入物¢)的具有第三径向部件(26)及第四径向部件(27)的彼等具体实例,植入物接收间隙(29)可进一步包括另一径向部件接收通道(74),其相应地允许第三及第四径向部件(26) (27)延伸入骶骨(4)或髂骨(5)的骨(无论软骨下骨、皮质骨、疏松骨或其类似骨)中,或骶髂关节植入物(6)压入无径向部件接收通道(74)的植入物接收间隙(29)中可强制推动径向部件(26) (27)进入骶骨(4)及髂骨(5)的骨中。机械扣件(39)(诸如有花纹部件)可穿过孔(36)插入于抗迀移组件

(33)中及进入骶骨⑷及髂骨(5)中以固定固着融合植入物(6)在植入物接收间隙(29)内的位置。

[0097] 现在参考图27及28A、28B及28C,作为第二非限制性实例,植入物接收间隙(29)的组态允许藉由与以上关于切开及产生到达骶髂关节(I)之上路关节部分的孔道所述类似的程序或步骤将骶髂关节植入物¢)的具体实例非横向置放在骶髂关节(I)的关节面

(16)的前侧部分(86)之间。

[0098] 现在参考图29及30,植入物接收间隙(29)的组态允许藉由与以上关于切开及产生到达骶髂关节(I)之下路关节部分的孔道所述类似的程序或步骤将骶髂关节植入物(6)的具体实例非横向置放在骶髂关节(I)的关节面(16)的前侧部分(87)与尾侧部分(86)之间。

[0099] 现在主要参考图31,其展示骶髂关节植入物(6)的一具体实例,该具体实例具有适于与对准工具(79)的一部分固定配合的轴孔(9)的一部分。对准工具(79)可具有固定或以可调方式固定的组态,其使管状对准导件(80)与穿过骶髂关节植入物¢)的孔(36)中的一者对准。插入工具(81)可与管状对准导件(80)滑动啮合。狭长部件(85)可以可移除方式与邻近骶髂关节植入物¢)中的孔(36)的第一插入工具端(82)固定附接。第二插入工具端(83)可被强制推进于管状对准导件(80)中以推进狭长部件(81)穿过孔(36),以相对于与骶髂关节植入物(6)相应啮合的该等关节面(16)呈横向关系地安置狭长部件

(81) ο作为一非限制性实例,狭长部件(81)可具有与外表面耦接的螺旋螺纹(84)且藉由旋转插入工具(81)的第二端(83),狭长部件(85)可被相对于与骶髂关节植入物(6)相应啮合的该等关节面(16)呈横向关系地牵引穿过骶髂关节植入物(I)的孔(36)。藉由进一步操作狭长部件(85),可与骶髂关节植入物¢)的外表面相抵地牵引骶髂关节(I)的关节面(16)ο

[0100] 现在主要参考图32,本发明的具体实例可进一步包含与骶髂关节植入物¢)的第一端(11)连接的耦接组件(87)。作为一非限制性实例,耦接组件(87)可藉由螺纹啮合扣件部分(88)而相对于骶髂关节植入物(6)的第一端(11)以固定关系安置;然而,本发明不如此受限制且扣件部分(88)可藉由诸如熔接、旋转熔接、黏着或其类似方法的任何方法与骶髂关节植入物(6)的第一端(11)连接。耦接组件(87)可进一步提供经组态以与悬跨部件(90)的众多及广泛多种横截面几何结构接合的耦接部分(89)。作为一非限制性实例,耦接部分(89)可组态成与扣件部分(88)枢接的圆柱状杯(91)。螺旋螺纹可与圆柱状杯

(91)的内表面耦接以可旋转地接收螺旋螺纹化本体(92)。圆柱状杯(91)的侧壁(93)可包括可接收悬跨部件(90)的一部分的穿通组件(94)。可藉由螺旋螺纹化本体(92)的旋转啮合而使悬跨部件(90)的接收于穿通组件(94)内的一部分与圆柱状杯(91)呈固定关系地置放。

[0101] 现在主要参考图33,作为另一非限制性实例,一对骶髂关节⑴中的每一者可接收各自具有与第一端(11)耦接的耦接组件(87)之上述骶髂关节植入物(6)的一具体实例。耦接组件(87)的每一者可接收悬跨部件(90)的相反端(95)。另外,与骶髂关节植入物(6)呈固定关系的悬跨部件(90)可与复数个额外悬跨部件(96)连接,作为一非限制性实例,该等额外悬跨部件可与脊柱(97)呈位置关系而置放以允许支撑可锚定在脊椎之间的额外植入物。

[0102] 现在主要参考图34,作为另一非限制性实例,第一耦接组件(87)可与如上所述的骶髂关节植入物(6)的一具体实例的第一端(11)接合且第二耦接组件(87)的扣件部分

(88)可直接安置入骶骨(4)或髂骨(5)或两者的骨中。呈平板形式的悬跨组件(90)的相反端(95)可为或可提供耦接组件(87)的扣件部分(88)可穿过的孔隙(96)。耦接部分(89)的外表面的相应部分与悬跨部件(90)可啮合以固定悬跨部件(90)的位置,从而允许藉由复数个固着组件将腰脊椎与经稳定骨盆耦接以进一步增加稳定性。

[0103] 方法可进一步采用手术中神经生理监测以降低患者神经系统(特定言的周边神经)的医原性损伤的风险,或向外科医师提供功能指导。

[0104] 实施例1

[0105] 在直接观测下及在辅助侧部荧光检查下,将具有实质上如图3-6所示及如上所述的组态的本发明骶髂关节植入物的一具体实例插入患者中。进行该程序以达成评估在实际付诸实施中在实质上如图25中所示的骶髂关节的关节面的下路部分或尾侧部分之间安全植入本发明骶髂关节植入物的能力的目的,以确认将骶髂关节植入物植入实质上如上所述经组态的植入物接收间隙中会起到使骶髂关节不动的作用。植入骶髂关节的下路(尾侧)部分中的如上所述的骶髂关节植入物证明会即刻使骶髂关节不动。

[0106] 如可由前述所容易了解,本发明的基本概念可以多种方式来体现。本发明涉及包括骶髂关节植入物的骶髂关节融合系统及植入骶髂关节植入物的方法(包括提供骶髂关节的固着及融合的最佳模式)的众多及变化的具体实例。

[0107]因而,由本说明书揭示或伴随本申请案的图或表中所示的本发明的特定具体实例或组件不意欲具有限制性,而意欲例示由本发明一般性涵盖的众多及变化的具体实例或关于其任何特定组件的所涵盖的等效物。此外,本发明的单一具体实例或组件的特定描述可能不明确描述所有可能的具体实例或组件;许多替代物系由本说明书及图隐含地揭示。

[0108] 应了解装置的各组件或方法的各步骤可由装置术语或方法术语描述。当需要使本发明所享有权利的隐含广泛覆盖范围明确时,此等术语可经替换。仅举例而言,应了解方法的所有步骤皆可揭示为动作、进行彼动作的手段、或引起彼动作的组件。类似地,装置的各组件皆可揭示为实体组件或彼实体组件所促成的动作。仅举例而言,揭示「一植入物」应理解成涵盖揭示「植入」的动作一无论是否明确论述一,且反的,若实际上揭示了「植入」的动作,则该种揭示应理解成涵盖揭示「一植入物」及甚至「植入部件的手段」。各组件或步骤的此等替代性术语应理解成明确包括在本说明书中。

[0109] 此外,关于所用的各术语,应了解除非其在本申请案中的利用与此等解释不一致,否则普通辞典定义应理解成包括在对如Random House Webster ' s UnabridgedDict1nary,第二版中所含的各术语的描述中,各定义特此以引用的方式并入本文中。

[0110] 出于本发明的目的,范围在本文中可表述为自「约」一特定值至「约」另一特定值。当表述该种范围时,另一具体实例包括自一特定值至另一特定值。类似地,当藉由使用先行词「约」以近似值形式表述值时,应了解特定值形成另一具体实例。应进一步了解每一范围的端点相对于另一端点及独立于另一端点均有效。此外,术语「约」意谓关于任何数值的在彼数值附近至多10%的偏差。

[0111] 此外,出于本发明的目的,术语「一」实体系指一或多个彼实体;举例而言,「一部件」或「一狭长部件」系指一或多个部件或至少I个部件。因而,术语「一」、「一或多个」及「至少I个」在本文中可互换使用。

[0112] 因此,应了解申请人主张至少:i)如本文中揭示及描述的骶髂关节植入物,ii)揭示及描述的相关方法,iii)此等器件及方法的每一者的类似、等效及甚至隐含变化形式,iv)达成所展示、揭示或描述的功能的每一者的彼等替代性具体实例,V)达成展示为对于达成揭示及描述的彼功能而言为隐含性的功能的每一者的彼等替代性设计及方法,vi)展示为单独及独立发明物的各特征、组件及步骤,vii)由揭示的各种系统或组件增强的应用,viii)由此等系统或组件产生的所得产品,ix)实质上如上文所述及参考任何随附实例的方法及装置,X)先前揭示的组件的每一者的各种组合及排列。

[0113] 本专利申请案的先前技术章节提供对本发明所属的努力领域的陈述。此章节亦可并入有或含有某些美国专利、专利申请案、公开案的释义;或所主张发明的适用于关联关于本发明所属技术状态的信息、问题或关切事件的标的物。不意欲将本文中引用或并入有的任何美国专利、专利申请案、公开案、陈述或其它信息解释为、理解为或视为欲承认为关于本发明的先前技术。

[0114] 本说明书中阐述的申请专利范围(若存在)特此以引用的方式并入作为本发明说明书的一部分,且申请人明确保留使用此等申请专利范围的此并入内容的所有或一部分作为支持任何或所有申请专利范围请求项或其任何要素或组件的额外描述的权利,且申请人进一步明确保留必要时将此等申请专利范围请求项或其任何要素或组分的并入内容的任何部分或全部自本说明书移动入申请专利范围中或反的亦然以界定本申请案或任何随后申请案或其接续案、分割案或部分接续申请案所寻求保护的标的物,或以符合任何国家或条约的专利法律、规则或法规的权利,且以引用的方式并入的此内容在本申请案(包括其任何随后接续案、分割案或部分接续申请案)的整个待审期或随后任何再颁予或延长期间将继续存在。

[0115] 本说明书中阐述的申请专利范围(若存在)进一步意欲描述有限数目的本发明较佳具体实例的边界及界限且不应解释为本发明的最广泛具体实例或可能主张的本发明的具体实例的完全清单。申请人不放弃基于以上阐述的本说明书产生其它申请专利范围作为任何接续案、分割案、或部分接续案或类似申请案的一部分的任何权利。

Claims (14)

1.一种骶髂关节植入物,其特征在于包含: 具有一定长度的安置在一第一端与一第二端之间的狭长本体,该狭长本体适于在该骶髂关节的关节面之间非横向定位以按实质上不动关系安置该骶骨及该髂骨; 沿该狭长本体的纵轴延伸、适于非横向定位在该骶髂关节的关节面之间的一第一径向部件; 沿该狭长本体的纵轴延伸、以与该第一径向部件呈实质上相对关系安置、适于非横向定位在该骶髂关节的所述关节面之间的一第二径向部件,每一所述第一径向部件及第二径向部件具有以实质上平行关系分开一厚度而安置、适于仅在由所述关节面界定的一区域内充分啮合该骶骨及该髂骨以按实质上不动关系安置该骶骨及该髂骨的一对相反面; 沿该狭长本体的纵轴延伸、适于延伸入该髂骨的骨中的一第三径向部件; 沿该狭长本体的纵轴延伸、适于延伸入该骶骨的骨中的一第四径向部件; 在该狭长本体的该第一端与一第二端之间连通的一轴孔;及 穿过该狭长本体的经定尺寸以允许一狭长部件按相对于所述关节面的横向关系穿过的一或多个孔道。
2.如权利要求1所述的骶髂关节植入物,其特征在于,该骶髂关节植入物具有适于置换由所述关节面界定的该区域内的该骶髂关节的一经移除部分的一组态。
3.如权利要求1所述的骶髂关节植入物,其特征在于,该骶髂关节植入物具有可接收在切入该骶髂关节中的植入物接收间隙内的一组态,其使该骶髂关节植入物实质上非横向定位在由该骶髂关节的所述关节面界定的该区域之间及该区域内。
4.如权利要求3所述的骶髂关节植入物,其特征在于,在该植入物接收间隙内的该骶髂关节植入物具有实质上避免实质性改变该骶骨与该髂骨的位置关系的一组态。
5.如权利要求3所述的骶髂关节植入物,其特征在于,在该植入物接收间隙内的该骶髂关节植入物具有实质上避免驱动该骶骨与该髂骨分开的一组态。
6.如权利要求3所述的骶髂关节植入物,其特征在于,在该植入物接收间隙内的该骶髂关节植入物具有使该骶骨及该髂骨返回至一正常位置关系以矫正该骶髂关节的一退化病状的一组态。
7.如权利要求1所述的骶髂关节植入物,其特征在于,该狭长部件具有尺寸足以避免在以实质上不动关系安置该骶骨及该髂骨时的变形的一组态。
8.如权利要求1所述的骶髂关节植入物,其特征在于,该狭长部件具有在该第一端与该第二端之间、适于仅在由该骶髂关节的所述关节面界定的该区域内啮合该骶骨及该髂骨的一组态。
9.如权利要求8所述的骶髂关节植入物,其特征在于,该狭长部件可具有选自由以下组成的群的一横截面组态:圆形、椭圆形、三角形、正方形及矩形。
10.如权利要求9所述的骶髂关节植入物,其特征在于,该狭长部件具有一大体上圆柱状外表面。
11.如权利要求1所述的骶髂关节植入物,其特征在于,进一步包含在所述第一径向部件或第二径向部件的相反面之间连通或横向穿过该狭长本体的一或多个孔隙组件。
12.如权利要求11所述的骶髂关节植入物,其特征在于,进一步包含与该骶髂关节植入物的一外表面的至少一部分耦接、能够与该髂骨或该骶骨的骨进行生物兼容骨整合的一涂层。
13.如权利要求12所述的骶髂关节植入物,其特征在于,进一步包含与定位于所述孔隙组件中之一或多者内的与一定量的生物兼容可生物降解或可骨整合材料混合的会促进骨生长的一或多种生物活性剂。
14.如权利要求1所述的骶髂关节植入物,其特征在于,该骶髂关节植入物的该第二端具有与一植入物插入工具配合的一组态。
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