CN101027016B - 软组织隔离件 - Google Patents

软组织隔离件 Download PDF

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Publication number
CN101027016B
CN101027016B CN2005800254558A CN200580025455A CN101027016B CN 101027016 B CN101027016 B CN 101027016B CN 2005800254558 A CN2005800254558 A CN 2005800254558A CN 200580025455 A CN200580025455 A CN 200580025455A CN 101027016 B CN101027016 B CN 101027016B
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China
Prior art keywords
separator
recess
bone
longitudinal axis
hole
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Expired - Fee Related
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CN2005800254558A
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English (en)
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CN101027016A (zh
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布赖恩·格里菲思
罗斯·J·海莫尔
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Synthes GmbH
HFSC Co
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HFSC Co
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Abstract

一种整形外科用组织隔离件(10)，其包括具有第一末端(16)和第二末端(18)、外表面(14)和纵轴线的本体部，所述末端(16、18)的至少一个被构造成与第一骨段接合，其中，本体部的至少一部分是弹性的，且所述外表面构造成可阻止组织粘连于其上。

Description

软组织隔离件
技术领域
本发明涉及采用移植物对组织或骨切除部位进行治疗的技术领域，采用移植物对病变、受损或有缺陷的骨和/或组织切除部位进行治疗的方法，将移植物与骨板组合的系统，包括移植物的工具箱以及移植物本身。更具体地，提供了软组织隔离件以作为弹性移植物而在切除部位的治疗过程中暂时地保持在切除空洞内。本发明尤其适用于涉及去除至少一部分骨和组织并随后对其进行治疗的过程，但本发明也可用于身体的其它适当部位。
背景技术
在各种修复术中所采用的移植物在许多领域中有广泛的应用。在某些情况下，病变、受损或有缺陷的骨和/或组织，如恶性肿瘤，都可能需要将产生病痛的组织和骨切除。当切除空洞较大时，可塞入移植物以填补组织或骨切除后留下的空间。一些情况下需要导入能无限期地保留在切除空洞中的永久性移植物。一般希望这种移植物具有足够的强度和生物相容性以与相邻的其它组织和骨共存并形成一体。用于代替骨的移植物通常是自体移植物、同种异体移植物或者例如钙磷酸盐或钙硫酸盐的陶瓷制品，或者是诸如不锈钢或钛金属的金属制品。
永久性移植物的预期优点也会导致一些缺陷。例如，虽然许多永久性移植物都由承载材料制成，但由这种材料制成的移植物可能对诸如放射治疗等过程不产生好的反应。金属移植物在放射治疗中起到“透镜”的作用，即有效地使放射波重调焦距和强化放射波而对准病人或外科医生身体上的较小部位。自体移植物则要求漫长的过程(例如采集、成形和培植)，因而时间紧促的情况则不能使用。
永久性自体移植物和同种异体移植物对于化疗也是反应甚微。化学疗法旨在杀死癌细胞，因为它们通常比周围的健康细胞弱。然而，自体移植物和同种异体移植物在插入切除空洞中时其细胞则通常处于略微削弱的状态。所以，化学疗法具有摧毁自体移植物或同种异体移植物本身的副作用，从而削弱永久性移植物而使其作用降低。而且，如果病人在受影响部位的供血不足，自体移植物和同种异体移植物也不能发挥作用。
因而，可以采用暂时性移植物来填补因产生病痛的组织和骨切除后留下的切除空洞。最终可以使用永久性移植物(例如自体移植物和同种异体移植物)，但需要在安装它们之前结束诸如放射治疗或化疗的治疗。以此方式使用的暂时性移植物可协助外科医生在骨和/或组织起初切除时到引入和放置永久性移植物这一段时间内保持切除空洞的尺寸。如果空洞在化疗或放射治疗这段时间内未被填满，包围此位点的软组织即会侵入因骨和/或组织切除而留下的空洞，从而妨碍接下来安装永久性移植物。所以，暂时性移植物具有阻止这种软组织侵入的优点，同时在化疗或放疗时期内也可提供近似于病人原本解剖体组织构造的短期装饰性替换体。
发明内容
提供了一种整形外科组织隔离件，其包括具有第一末端和第二末端、外表面和纵轴线的本体部，至少一个所述末端被构造成与第一骨段接合，其中，至少一部分所述本体部是具有弹性的，所述外表面被构造成阻止组织粘连于其上。
所述本体部的弹性可以通过在该本体的至少一部分上设置至少一个凹口来实现。至少一个凹口具有的深度可以小于所述隔离件的横截面尺寸。所述至少一个凹口还可以具有长度，其中所述凹口的深度沿着该凹口的长度是变化的。所述本体部可以具有多个凹口，其中至少两个所述凹口具有不同的尺寸。所述本体部还可以具有多个凹口，其中该凹口沿着所述隔离件纵轴线基本上是等距隔开的。
所述隔离件的生物相容性材料也可以是无生物活动性的。该生物相容性材料还可以是超高分子量聚乙烯(UHMWPE)或聚醚醚酮(PEEK)。该生物相容性材料还可以阻止组织向内生长和/或粘连。
所述本体部还可以包括横截面大致呈椭圆形的外表面，或者制成为与被切除的骨的横截面形状相似。
所述隔离件的末端可以具有互不相同的形状。各个末端具有的形状可以基本与所接触的骨段相符。
所述隔离件的至少一部分可以用至少一种治疗性试剂包被。所述治疗性试剂可以是抗生素或杀菌剂。该治疗性试剂可以通过喷涂、浸沾、浸泡、灌输、或化学蒸发沉积或者这些方式的组合而得到应用。该治疗性试剂可选自IGF(胰岛素类生长因子)、TGF(转化生长因子)、FGB(纤维原细胞生长因子)、EGF(表皮生长因子)、BMP(骨形态发生蛋白)和PDGF(血小板衍生生长因子)。
所述隔离件具有孔，该孔的纵轴线与所述本体部的纵轴线基本平行或不平行。该孔可以占据所述隔离件的约90％的横截面积。该孔的厚度也可以大致小于所述末端的相应厚度。该隔离件还可以具有多个适于接纳至少一根缝合线的孔。
所述隔离件还可以包括外表面，和孔，该孔的内表面基本上与所述外表面的形状相符。
所述隔离件可以预成形为一预选择的形状。该预选择的形状可以构造成基本上与被切除的骨的至少一部分相似。该被切除的骨可以是人下颚部的一部分。
所述隔离件的本体部的至少一部分可以是钝化磨光或粗磨光的，以减少外科手术工作部位中的光滑表面。所述隔离件的至少一个末端还可以是粗磨光的，以加强该末端与相关骨段的接合。
本发明还公开了一种治疗切除空洞的方法，其包括以下步骤：(a)从身体部位去除第一量的组织，至少一部分所述组织是病变、受损或有缺陷的，从而留下空洞；(b)选择用于暂时置于所述空洞内的第一隔离件；(c)将所述第一隔离件置于所述空洞中；以及(d)在所述身体部位进行至少一种治疗。
所述方法还可以包括从所述身体部位切除骨。可以切除第二量的骨或组织。所述隔离件还可以在治疗后从所述空洞中移除。可以选择第二隔离件并安置以永久地导入到该空洞中。
所述隔离件的一部分可以在使用前被切除。该隔离件可在使用前弯曲以较好地与身体部位相符。该隔离件可以是具有弹性的，从而在插入时该隔离件的末端可对所述空洞的至少一部分施加作用力。
在插入所述隔离件前，可以将骨板与身体部位的相邻处连接。该隔离件可以固定地与所述骨板连接。
所述治疗方法可以包括化疗和/或放射治疗。
所述隔离件在插入之后可缝在相邻的骨或组织上。
本发明还公开了治疗切除的空洞的系统，其包括隔离件，该隔离件包括由生物相容性材料制成的本体部，所述本体部具有第一侧和第二侧以及中心纵轴线；其中，所述边侧的至少一侧是骨接合侧；其中，所述本体部的至少一部分可以通过外力弯曲；和至少一个骨板固定地与所述隔离件连接。
所述骨板可以用粘结剂与所述隔离件连接。该骨板可以用扣件与所述隔离件连接。因此，该隔离件可以具有至少一个容纳扣件的孔。
本发明还公开了一种工具箱，其包括：多个隔离件；至少一个骨板；其中，所述隔离件的至少一个被选择来暂时地置于切除的空洞中。该工具箱还包括至少一个扣件或至少一个工具。所述工具可以是对齐仪器或切割仪器。
所述隔离件的尺寸主要地可以根据所需填补的切除的空洞的尺寸而改变。在大部分情况下，该隔离件的形状可以选择成最好地复制在切除操作过程中被切除的组织和骨的尺寸和形状。
在外科手术过程中可以改变或者用其它方式定制所述隔离件以精确地配合各个病人的切除空洞。根据在外科手术之前对病人身体的至少一部分进行CT或MRI成像所采集的信息，还可制造预定形状的移植物以适应各个病人。
所述凹口可以具有各种构型和深度。在一个实施方案中，至少一个凹口具有的深度小于前侧和后侧之间的距离。在另一个实施方案中，至少一个凹口具有的深度等于前侧和后侧之间的距离。各个凹口的深度和对应容积至少部分地决定了所述隔离件在各个凹口的特定部位的弹性。而且，单个凹口的深度可以沿着凹口的纵轴线变化。例如可采用这种一种方案，当在靠近所述隔离件的中心使用较深的凹口时，在该隔离件的末端周围使用较浅的凹口。
单个隔离件中至少有两个凹口的尺寸可以不同。而且，在单个隔离件中的所有凹口可以具有与其上的其它凹口不同的尺寸和形状。可以设想凹口的任意组合或形式，以使外科医生可采用能够与切除空洞所需的物理特性最佳适合的隔离件。
在前侧的所述凹口可以是基本上平行的，且沿着所述隔离件的纵轴线大致等距间隔。然而，该凹口的深度、宽度和长度可以根据多个因素而变化，包括所述隔离件的尺寸和外科医生所需的弹性。
所述第一切除操作可包括去除组织或骨或两者。接下来的切除操作可以是必需的，以去除所需量的组织或骨或两者。任何接下来的切除操作可以在第一切除操作之后的任何时候进行。
在进行第一切除操作之前还可选择第一隔离件。这种方案可使外科医生在开始进行第一切除操作之前估计最终的空洞尺寸和形状。
所述第一隔离件也可以在治疗发生之后取出。此时，外科医生可以准备将永久性移植物安装到空洞中。或者，外科医生如果认为必要，可以进行另一次切除操作。
在所述第一隔离件取出后，可选择将要导入空洞内并随后置于该空洞内的第二隔离件。该第二隔离件可以是暂时的或永久的。
附图说明
本发明的大量特征都揭示在附图中，其中类似的附图标记在几幅图中表示类似的部件，且其中：
图1是本发明的所述隔离件的第一示例性实施方案的俯视图；
图2是图1的隔离件的侧视图；
图3是图1的隔离件的立体图，显示了该隔离件的至少一部分被治疗性试剂包被，还显示了大致呈椭圆形的末端；
图4是隔离件的第二实施方案的立体图，该隔离件具有延伸通过其纵轴线的孔；
图5A是所述隔离件的第三实施方案的侧视图，该隔离件具有预成形的弯曲；
图5B是图5A的隔离件的俯视图；
图6A是所述隔离件的第四实施方案的侧视图，该隔离件具有绕轴线B的预成形的弯曲；
图6B是图6A的隔离件的俯视图；
图7A是隔离件的第五实施方案的侧视图，该隔离件具有弯曲预成形的形状，具有与下颚骨的一部分相符的至少一个末端和成角度的相对末端；
图7B是图7A的隔离件的俯视图；
图8是具有切除空洞的下颚骨的立体图；
图9是图8的下颚骨的立体图，在其上已固定了图1的隔离件和骨板。
优选实施方案的详细描述
参见图1-2，图中示出了在人体中使用的暂时性软组织隔离件的示例性非结构性立体隔离件10。具体地，该隔离件10可构造成置于，例如因受损或病变的骨部分被切除后所获得的切开的骨的两末端之间。如前所述，当对病人的切除部位进行治疗性处理(例如化疗、放疗)时可采用暂时性隔离件，因为这种处理会妨碍永久性隔离件，如同种异体移植物(如骨)再整合。该隔离件10可具有与被替换的骨和组织(以及永久性移植物)相似的物理特性(尺寸和形状)，以在接下来的治疗期中使病人看起来尽可能地与正常的一致。
因而，所述隔离件10可具有外表面14，第一骨接合末端16和第二骨接合末端18以及轴线A。该隔离件10的表面和末端可以是平的、弯曲的或呈任何适当的形状以使该隔离件具有所需的整体形状。该外表面14和末端16、18可以是粗糙的以提高该隔离件10在切除空洞70中的保持力。
所述隔离件10上的雕刻式切口12可使该隔离件能够弯曲、展开或收缩以紧密地与所填补的空洞配合。该隔离件10可沿其至少一条轴线弯曲、展开或收缩。在图1所示的实施方案中，该雕刻式切口12基本上相互平行并且沿着该隔离件10的纵轴线A大致等距隔开。该雕刻式切口12还定向成大致与纵轴线A垂直，因而该隔离件10可以展开或收缩。至少部分地取决于该隔离件10所需的弹性以其整体尺寸和形状，该雕刻式切口12的定位可以在宽度、长度和角度方向上有变化。该雕刻式切口12可具有三个尺寸：长度L、宽度W和深度D。根据该隔离件10所需的弹性和/或弹性方向及其整体尺寸和形状，各个尺寸可以改变。例如，该长度L可以在0.1毫米到30毫米内变化。该宽度W可以为约0.1毫米或更大。该深度D可以在0.1毫米到20毫米内变化。因此，尺寸L、W、D各自可以是相应隔离件尺寸的约0％至90％。该雕刻式切口12之间的距离Z也可以变化。在单个隔离件10中，该雕刻式切口12的所述尺寸在各个雕刻式切口12之间可以变化。另外，单个雕刻式切口12的尺寸还可以在单个雕刻式切口12中变化。例如，可以优选地沿着雕刻式切口12的长度L改变其深度D，以在所述隔离件10中心附近处形成较深的雕刻式切口12，而在该隔离件10边缘附近处形成较浅的雕刻式切口12。这种设置可以使该隔离件10沿其纵轴线A具有较大弹性而沿其边缘具有较小弹性。例如，当该隔离件10用于与下颚部的弯曲部分配合时，该隔离件的雕刻式切口12被构造成使该隔离件10在可与下颚部的弯曲配合的方向上弯曲，而在垂直方向上具有硬度。类似地，特定雕刻式切口的宽度W可以沿其长度L而改变，以在所需方向上提供额外的弹性。本领域中普通技术人员可以了解，本发明的隔离件10可以根据需要结合任何具有不同尺寸的雕刻式切口12的组合，而使该隔离件10具有所需的弹性以配合特定靶向的解剖结构切除空洞。
在一个实施方案中，所述隔离件10的大致横截面尺寸约为(20毫米×8毫米)至(30毫米×12毫米)。在图1-2所示实施方案中，所述雕刻式切口12延伸的深度D大约等于该隔离件10高度X的一半。在此实施方案中，所有雕刻式切口12的深度D还可以是一致的。然而，该雕刻式切口12的深度D也可小于距离X的一半。同样地，该雕刻式切口12的深度D也可以比距离X一半大。在另一实施方案中，该雕刻式切口12可以延伸完全通过该隔离件10的本体60，而形成从所述外表面14上的一点经过该本体60而从该外表面14另一点伸出的雕刻式切口12。如前所述，具有多种雕刻式切口12深度D选择可能是理想的，因为该雕刻式切口深度D对该隔离件10所具有的弹性度至少部分地具有贡献。
如图3所示，所述隔离件可具有至少两末端16、18，其各自为大致呈椭圆形。然而，该末端16、18也可以是任何所需的形状或尺寸，以使该隔离件10整体具有所需的形状。而且，该末端16、18可以具有彼此不同的形状。因此，该隔离件10的横截面形状和尺寸可沿纵轴线A改变，至少部分地作为该末端16、18的尺寸差异的函数而改变。为使该隔离件10与非规则形状的切除空洞70之间配合更精确，提供具有可变横截面形状的隔离件是理想的。
参见图4，所述隔离件10可具有其轴线C(未示出)基本与该隔离件10的纵轴线A位于同一直线上的孔30。与前述的实施方案相比，该孔30可使该隔离件10的弹性增强。该孔30还可使该隔离件10的重量减轻。当该隔离件10用固有地比非金属材料更硬和更重的金属制造时，这些特征是特别有利的。
在一个实施方案中，所述孔30的尺寸和形状可与所述隔离件10的外边缘32的形状相近似，以使该隔离件10的厚度T大致保持一致。因而，该隔离件10的厚度T在约1.5毫米至5毫米的范围内。可以理解，恒定的厚度T并不是至关重要的，因此在该隔离件的长度方向上厚度T有变化是可以的。所以，该孔30可以是任何适于使该隔离件10具有所需弹性的尺寸形状。例如，外边缘32的形状可以是椭圆形，而内边缘34的形状可以是圆形、方形等。该孔30的横截面形状和尺寸也可以沿纵轴线A的长度方向上有变化。该孔30可包括至少一个通道以用于使某物件，如缝合线、缆线或其它支持件穿过该隔离件10的本体60的至少一个部分。或者，在单个隔离件10上可以提供多个孔30。
图5A-7B示出了具有不同预成形形状的所述隔离件10的多个视图。图5A的隔离件10大致呈凹形设计，可用于不规则的切除空洞70中，其中该空洞是由于将病变或受损的骨“雕刻”成水槽形状而形成的。单个雕刻式切口12的尺寸至少部分地可以根据雕刻式切口12相对于移位轴线的位置而变化。图5B是图5A的隔离件的俯视图。
图6A的隔离件10从一个侧面来看大致是拱形设计。这种特定的设计可以用于暂时替代人的下颚部50的前段。在此实施方案中，该隔离件10围绕轴线B发生移位。图6B是图6A的隔离件10的俯视图。
图7A的隔离件10从一个侧面来看是非规则的设计。此实施方案可以用来暂时替代人的下颚部50(见图8)中部的一部分，其中，切除空洞70的横向边界是非规则形状的骨壁54。在此实施方案中，第一侧16成形为大致与下颚部的非规则横截面形状相符，而第二侧具有角度。图7B是图7A的隔离件10的俯视图。一般地，该隔离件10可具有预成形形状以大致与该隔离件10的目标用途和/或定位相符。所述外表面14和末端16、18也可以各自预成形为与目标骨空洞70的骨末端更紧密配合。
为使所述隔离件10与切除空洞更加相符，外科医生也可以改变该隔离件10的形状或设计以适应病人的特定解剖结构。因而，外科医生可在使用前去除该隔离件10的至少一部分。例如，外科医生可切除该隔离件10的一末端或两末端16、18的至少一部分，或者去除该隔离件本体的一部分或多个部分。外科医生还可以切下隔离件上的定制雕刻式切口12，或者改变现有的雕刻式切口12以使它们更深或更长。该隔离件的形状可以采用多种标准外科工具，如圆头锉、往复式拉锯、钻器等来改变，这些工具都是外科医生在手术室中可以得到的。外科医生可以改变该隔离件10的形状，不论该隔离件10是否是预成形的。
参见图8，图中示出了包括牙齿52和切除空洞70的示例性病人下颚部50。图示的切除空洞70可以是由于去除病变或受损组织和/或骨的操作形成的，但是其它的操作(例如美容整形)也是在预期内的，例如在病人患有先天性畸形或骨缺损时。壁54可形成切除空洞70表面积的至少一部分。该壁54的形状和总表面积可以至少部分地取决于在切除操作中去除的组织和/或骨的尺寸和形状。该壁54表面的轮廓也是可以改变的。在切除空洞70任一侧的健康骨部分56A、56B可以保持完整。
参见图9，采用具有多个固定孔44的骨板40将所示的隔离件10固定地连接到下颚部50的切除空洞70中。在此实施方案中，该隔离件10置于切除空洞70中且骨板40固定地与该隔离件10和下颚部50连接(例如采用置于固定孔44中的骨钉)。该骨板40可用于将该隔离件10保持在切除空洞70中，因为该隔离件10本身不是承载部件。所以，如果没有诸如骨板的其它保持装置，该隔离件可能就不能有效地抵抗肌肉组织和软组织的原位作用力。该骨板40因而可以帮助防止该隔离件10受到在使用过程中作用于该隔离件10暴露部分上的外力(例如咀嚼或其它软组织作用力)而引起的运动或移位。这种移位可能是不需要的，因为其可使软组织和骨内生进所述切除空洞中。另外，该隔离件10的运动还会在切除空洞70内及周围引发感染。
所述骨板40可以以多种方式与所述隔离件10和壁56A、56B连接。图9示出了该骨板40，其通过容纳在该隔离件10的孔中的多个扣件42而固定地与该隔离件连接。扣件42的数量、尺寸和设置可以至少部分地根据该骨板40的尺寸和使隔离件10充分固定所必需的固定力来改变。然而，该骨板40可通过任何适当的方式连接到隔离件10上，包括螺钉、钉子、夹子、销、缝合线、粘结剂或其组合，但不仅限于此。该骨板40也可具有任何适当数量和构造的扣件孔，且可以是弹性的或可变形的以使外科医生可以使该骨板的末端成形为适应病人的解剖结构。该骨板40可用本领域中任何适当的材料制成，包括诸如钛或不锈钢的金属材料，或聚合物，再吸收聚合物等。
而且，虽然所述隔离件10在此描述为适用于采用骨板40而固定到相邻的骨段上，但也可以使用其它固定技术。例如，可以直接将骨螺钉拧过该隔离件而进入相邻的骨段。在这些情况下，该隔离件可具有预成形的骨螺钉孔。或者，该隔离件可具有一个或多个构造成与所述骨末端的外表面接合的一体成形或预成形翼片。这些翼片可具有预成形骨螺钉孔以将该隔离件固定到相邻的骨上。另外，该隔离件10可具有一个或多个适于接纳缝合线的孔以使外科医生将该隔离件10缝合到周围的骨和组织上。这些孔可以是任何合适的形状和构造，且可相对于该隔离件10的纵轴线成角度以便易于将缝合线材料穿过该隔离件。
所述隔离件10的至少一部分可用治疗性试剂20包被，这有助于防止在该隔离件10插入切除空洞70之后在所述部位引发感染。该治疗性试剂20可以是适于防止切除空洞70内的感染的任何合适试剂，包括抗生素和杀菌剂。在涉及隔离件的操作中有用的治疗性试剂的非限制性例子包括但不限于：骨生长诱导催化剂，如骨形态形成蛋白、生长素、肽聚糖等；抗病毒药；抗生素；化疗药；生长因子；内皮生长因子；胰岛素生长因子等；或其组合。另外，该隔离件10可以用多种治疗性试剂20包被。该治疗性试剂20可以通过任何合适的方法应用到该隔离件10上，该方法包括但不限于：喷涂、灌输、浸泡、浸沾或化学蒸发沉积(CVD)。在一个实施方案中，该治疗性试剂20可以通过将所述隔离件10浸泡或浸沾在溶解的再吸收材料，如含有所需浓度的治疗性试剂20的聚乳酸中而应用到该隔离件10上。在由Schmidmaier等人于2001年3月9日提交的名称为“生物学活性移植物”的美国非临时专利申请09/801,752中，对这些将治疗性试剂应用到移植物上的一种方式作了讨论。该篇文献所有内容引用于此作为参考。
结合图9所示的系统，进一步说明使用本发明的隔离件10的示例性方法。在确定了解剖结构(在此是下颚部50)的病变或受损部分之后，外科医生可去除受影响的组织，以及所有侧边上的少部分健康组织，这样产生切除空洞70。然后外科医生选择置于该切除空洞70内的隔离件10。在一个实施方案中，该隔离件10可以用至少一种治疗性试剂20包被。可以在选择或放置隔离件10之前使用该治疗性试剂20。在将该隔离件10插入到切除空洞70之前，外科医生可以压缩、展开或以其它方式改变该隔离件10的形状(例如，去除该隔离件的至少一部分)以使其与该切除空洞70紧密配合。然后将该隔离件10插入到切除空洞70中。可选择长度略大于切除空洞70的隔离件10，这样当该隔离件10插入到所述空洞中时，小的末端作用力通过所述壁54而作用到末端16、18上，因而可以将该隔离件10临时地保持在该切除空洞70中。因此，该隔离件10的末端16、18可定位成沿下颚部50的长至少部分地抵靠在切除空洞70的壁54上。该末端16、18可以与骨或组织接合。在放置过程中，该隔离件10的雕刻式切口12可提供弹性以使该隔离件10展开或压缩而填补切除空洞70。一旦将该隔离件置于切除空洞70中，可以将至少一个骨板40固定地与该隔离件10以及周围的骨或组织连接。或者，可以在该隔离件10放置到切除空洞70中之前将骨板40应用到该隔离件10上。外科医生还可以通过反复地将该隔离件10插入切除空洞70和从中取出而对该隔离件10在切除空洞70内进行“试配”，根据需要每次再成形(切削)该隔离件10以获得理想的配合。一旦获得理想的隔离件形状，可以将该隔离件10和骨板40固定到骨末端56A、56B上。可以注意到，虽然所公开的隔离件10是与骨板40组合在一起的，但是该隔离件10也可以采用如前所述的任何合适的方法来固定到骨末端56A、56B上。类似地，在不采用任何其它的固定方式的情况下该隔离件10也可使用。
在此阶段，即在外科手术部位被封闭之前，还可以对所述隔离件10、骨板40、和/或切除空洞70应用额外剂量的治疗性试剂20。这是优选的，因为在该隔离件10的制备和将其安置于切除空洞中和/或将该隔离件10与骨板40连接的过程中会损失一些治疗性试剂20。
然后，外科医生可着手治疗外科手术部位。这种治疗的例子包括但不限于：放射治疗、化疗、等压治疗(isobaric treatments)等。
在操作后期间，还可以简单地使用所述隔离件以减少肿胀和促进全面愈合。
在治疗完成之后，外科医生接着可再进入外科手术部位并取出所述隔离件10和骨板40。然后，可以将永久性移植物，如用自体移植物、同种异体移植物、金属、陶瓷、聚合物或其它适当材料制成的永久性移植物插入到切除空洞70中。
所述隔离件10除了上述用于下颚部之外，该隔离件10还可用于身体的其它部位。一种是用于臀部。具体地，该隔离件10可以用作移植物以用于从髋骨嵴取出移植体而形成的切除空洞70中。这种移植体通常用于脊椎融合术或其它骨移植操作中。可以使用本发明的隔离件10的其它区域是颅面区域的任何骨，包括颊骨。
所述隔离件10可由生物相容性材料，例如超高分子量的聚乙烯(UHMWPE)制成。然而，该隔离件10可以不用生物相容性材料制成。除了UHMW PE之外，用于本发明的其它可接受的生物相容性材料包括但不限于：钛合金、不锈钢、钴铬合金以及PEEK。所选择的生物相容性材料应使所述隔离件10能够与切除空洞70(如图8所示)的相对骨末端相符或可与之相符，并且应当能够保持空洞在进行诸如放射或化疗治疗操作的时期内不受软组织侵入。更具体地，当置于切除空洞70内时，该生物相容性材料应当可阻止组织和骨向内生长或粘连。因而，该隔离件10应当构造成容易地从该切除空洞70中取出，从而可以在放疗或化疗操作完成时容易地安装永久性移植物。
所述隔离件10的外表面14和末端16、18也可是钝化的，这有助于防止操作过程中所使用的内诊镜光源的炫目或反射。
虽然参照特定的实施方案对本发明作了图示和描述，但是可以理解，在不偏离本发明的精神和范围的情况下，可以对所述的具体实施方案在实践中所使用的及特别适于具体环境和操作需要的形式、结构、设置、比例、材料和组分进行各种添加、替代或修饰或其它形式的改变。因此，可以理解，本说明书所公开的这些实施方案仅起到说明本发明原理的作用。本领域的普通技术人员采用本发明的原理可作出多种其它的变化，这些变化都落入本发明精神和范围内。

Claims (34)

1.一种整形外科用组织隔离件，其包括：
本体部，其包括，
前侧、后侧、第一末端、和第二末端，所述第一和第二末端中至少一个被构造成与骨段接合；
外表面和中心纵轴线，其中所述中心纵轴线从第一末端延伸至第二末端，所述外表面被构造成阻止组织粘连于其上；
至少一个凹口，其从前侧延伸进入本体部；
至少一个凹口，其从后侧延伸进入本体部；
其中所述从前侧延伸进入本体部的凹口与从后侧延伸进入本体部的凹口沿着中心纵轴线从本体部的第一末端向第二末端交替地排列，且所述凹口具有的深度小于或等于前侧和后侧之间的距离；并且，所述凹口构造成至少一部分所述本体部是具有弹性的。
2.如权利要求1所述的隔离件，其特征在于，所述隔离件具有高度并且每一凹口均具有深度，所述每一凹口的深度大于所述隔离件高度的一半。
3.如权利要求1所述的隔离件，其特征在于，所述每一凹口具有长度，以及具有沿着从外表面至中心轴线的方向延伸的深度，其中该凹口的深度沿着其长度变化。
4.如权利要求1所述的隔离件，其特征在于，其中至少两个所述凹口具有不同的尺寸。
5.如权利要求1所述的隔离件，其特征在于，所述凹口基本上是平行的。
6.如权利要求1所述的隔离件，其特征在于，所述凹口沿着纵轴线基本上等距隔开。
7.如权利要求1所述的隔离件，其特征在于，由生物相容性材料制成，其中所述生物相容性材料为无生物活性的材料。
8.如权利要求7所述的隔离件，其特征在于，所述生物相容性材料是超高分子量聚乙烯。
9.如权利要求7所述的隔离件，其特征在于，所述生物相容性材料能够阻止组织向内生长和/或粘连。
10.如权利要求1所述的隔离件，其特征在于，所述本体部还包括横截面大致呈椭圆形的外表面。
11.如权利要求1所述的隔离件，其特征在于，所述第一末端和第二末端具有互不相同的形状。
12.如权利要求1所述的隔离件，其特征在于，第一末端和第二末端分别具有的形状基本与所接触的骨段相符。
13.如权利要求1所述的隔离件，其特征在于，所述隔离件的至少一部分用至少一种治疗性试剂包被。
14.如权利要求13所述的隔离件，其特征在于，所述治疗性试剂是抗生素。
15.如权利要求13所述的隔离件，其特征在于，所述治疗性试剂是杀
菌剂。
16.如权利要求13所述的隔离件，其特征在于，至少一种治疗性试剂是通过喷涂、浸沾、浸泡、灌输、或化学蒸发沉积或者这些方式的组合而应用的。
17.如权利要求13所述的隔离件，其特征在于，所述至少一种治疗性试剂至少部分地选自胰岛素类生长因子、转化生长因子、纤维原细胞生长因子、表皮生长因子、骨形态发生蛋白和血小板衍生生长因子。
18.如权利要求1所述的隔离件，其特征在于，进一步包括具有纵轴线的孔，该孔设置为使孔的纵轴线与所述隔离件的本体的纵轴线是基本平行。
19.如权利要求18所述的隔离件，其特征在于，所述孔占据所述隔离件的90％的横截面积。
20.如权利要求18所述的隔离件，其特征在于，所述隔离件的各个末端具有截面尺寸，其中所述孔沿着所述隔离件的纵轴线的长具有直径，且其中该直径小于所述各个末端的所述截面尺寸。
21.如权利要求18所述的隔离件，其特征在于，所述孔具有的内表面基本上与该隔离件的外表面的形状相符。
22.如权利要求1所述的隔离件，其特征在于，所述隔离件预成形为预选择的形状。
23.如权利要求22所述的隔离件，其特征在于，所述预选择的形状被构造成基本上与被切除的骨的至少一部分相似。
24.如权利要求23所述的隔离件，其特征在于，所述被切除的骨是人下颚部的一部分。
25.如权利要求24所述的隔离件，其特征在于，所述被切除的骨是人下巴的一部分。
26.如权利要求1所述的隔离件，其特征在于，所述本体部的至少一部分是钝化磨光的，以减少外科手术工作部位中的光滑表面。
27.如权利要求1所述的隔离件，其特征在于，所述本体部的至少一部分是粗磨光的，以减少外科手术工作部位中的光滑表面。
28.如权利要求1所述的隔离件，其特征在于，至少一个所述末端是粗磨光的，以加强该末端与相关骨段的接合。
29.如权利要求1所述的隔离件，其特征在于，进一步包括具有纵轴线的孔，该孔设置为使孔的纵轴线与所述隔离件的本体的纵轴线是不平行。
30.一种用于治疗切除空洞的工具箱，其包括：
多个权利要求1所述的组织隔离件；
至少一个骨板；
其中，至少一个隔离件被选择来暂时地置于切除空洞中。
31.如权利要求30所述的工具箱，其特征在于，还包括至少一个扣件。
32.如权利要求30所述的工具箱，其特征在于，还包括至少一个工具。
33.如权利要求32所述的工具箱，其特征在于，至少一个工具是对齐仪器。
34.如权利要求32所述的工具箱，其特征在于，至少一个工具是切割仪器。
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EP1755496A4 (en) 2009-08-05
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CA2568941C (en) 2014-04-01
CA2568941A1 (en) 2005-12-15
AU2005249556A1 (en) 2005-12-15
KR20070028511A (ko) 2007-03-12
ZA200700095B (en) 2008-05-28
US7887587B2 (en) 2011-02-15
CN101027016A (zh) 2007-08-29
US20050273165A1 (en) 2005-12-08
WO2005117760A3 (en) 2006-09-14
EP1755496A2 (en) 2007-02-28
US8945220B2 (en) 2015-02-03
BRPI0511813A (pt) 2008-01-29
US20110098760A1 (en) 2011-04-28
KR101166181B1 (ko) 2012-07-18

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