CN110891520A - 骨增量件和由具有插入的(牙)植入物的骨增量件构成的套件 - Google Patents

骨增量件和由具有插入的(牙)植入物的骨增量件构成的套件 Download PDF

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CN110891520A
CN110891520A CN201880046010.5A CN201880046010A CN110891520A CN 110891520 A CN110891520 A CN 110891520A CN 201880046010 A CN201880046010 A CN 201880046010A CN 110891520 A CN110891520 A CN 110891520A
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bone
bone augmentation
implant
defect
mesh
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CN110891520B (zh
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马丁·吕克尔
哈拉尔德·埃西希
弗兰克·赖瑙尔
阿德姆·阿克苏
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Karl Leibinger Medizintechnik GmbH and Co KG
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Abstract

本发明涉及一种用于填充骨(3)中的缺陷(2)的骨增量件(1)，其具有基体(5)，所述基体适于无隙地被插入所述缺陷(2)，其中所述基体(5)具有由连接片(6)和空腔(7)构成的桁架状结构。本发明还涉及一种由这种骨增量件(1)构成的套件，所述骨增量件具有插入其中的植入物，如种植牙。本发明还涉及一种根据本发明类型的骨增量件(1)作为钻孔模板(18)的应用。

Description

骨增量件和由具有插入的(牙)植入物的骨增量件构成的套件
本发明涉及一种骨增量件，其用于填充如上颌骨或下颌骨之类的骨中的缺陷，如孔洞、缝隙或间隙，但所述骨增量件处于牙颌畸形应用领域之外。
现有技术中已经揭露了许多骨植入物，但迄今为止还未揭示作为骨增量件填充骨中的缺陷的骨植入物。通常将板件施加在骨外侧，以便将孔洞或缺陷固定在其位置上，然后将骨填充材料(如颗粒)放入所述缺陷中。但是，这种颗粒总是具有自身形状不稳定的缺点。必须费力地将单个颗粒成分移入所述缺陷中，并在此处压实，只有这样才能随时间逐渐加固。
但是，应该要更快地实现成功治疗并且实现对手术医生而言更好的可操作性。还应该提供确保手术良好成功的快速生长且成本低廉的骨植入物。
在承载牙的牙槽嵴区域中出现骨损失的情况下，例如在事故、良性或恶性肿瘤切除、炎症和其他适应症的框架下，通常建议重建骨性牙槽嵴(增量)并随后插入牙植入物。其中，常见措施是自体骨移植。为此，局部地(例如在下颌的面中部/未承载牙的部分中)，特别是从髂骨翼中移除骨。为避免随后在供体部位中出现移除缺损和发病率，越来越多地使用异质颗粒来对牙槽嵴进行增量。但是，这些颗粒形状不稳定且必须通过额外的膜来保护其免受结缔组织的非期望生长的影响。最近以来，开发了3D钛网，其解决了缺乏形状稳定性的缺点，但其必须在规划的牙植入之前完全被移除。
然而，自体骨移植具有以下缺点：供体部位中的移除发病率、针对缺损情况的复杂的轮廓化必要性以及骨的局部可用性中的限制。可惜异质颗粒形状不稳定并且需要膜，因为这些颗粒自身不具有膜特性，也无法进行集成的3D规划。遗憾的是，3D钛网是不可吸收的，也不具有膜特性，必须在植入前被移除。然而大量的干预措施恰好又是非期望的。
因此，本发明的目的是克服上述缺点。
本发明用以达成上述目的的解决方案在于，所述用于填充/装填缺陷的骨增量件配设有基体，所述基体适于尽可能无隙地被插入所述缺陷，其中所述实心的或大孔/微孔的基体具有由自身也可以采用实心或大孔/微孔构建方案的连接片/连铸坯构成的桁架状结构以及空腔，以便例如形状稳定，以及，所述基体包含可生物降解的金属材料和/或可吸收的聚合物或陶瓷材料或者由此制成。也就是说，初始形状稳定性会在插入所述骨增量件时有所帮助。
此外，通过所述由生物降解材料构成的桁架状结构，一方面骨材料长入所述植入物对快速的骨构建起到支持作用，另一方面，由于所述植入物分解并且因此仅骨材料留在体内，因而产生了几乎原始或天然的结构。由于在所述骨材料和所述植入物之间存在较大的表面接触，因而也通过所述晶格状结构加速外源材料的分解。
有利实施方式参阅从属权利要求并且下文将对这些有利实施方式进行详细说明。
因此，有利的是，多个连接片相交叉，所述连接片在所述交叉点上彼此相连，优选在此处以一体成型/采用同一材料的方式相连，如此使得这些连接片在所述交叉点上以形成整体式构件的方式连接在一起。
有利地，所述连接片形成晶格结构。其中，形成网目。在此情况下，所述网目应全部或大多具有(大致或精确)相同的面积。这样就能准确地对生长进行控制或者预测。在此情况下，所述具有构建性骨材料的晶格结构的杂生特别均衡，这就带来了手术的良好成功。
对制造而言有利的是，所述网目具有三角形形状，特别是等边或等腰三角形，或者所述网目具有矩形形状，特别是等边矩形/正方形。在此情况下，可以特别好地预定所述连接片/连铸坯的布置方案，从而有助于制造。
在这些连接片，例如所有连接片或大多数连接片在几何形状上和/或在所述材料特性方面采用相同方案时，可以特别有效地确定/设置初始形状稳定性。
其中，有利的是，所述连接片采用线性/直线或波状或曲线的构建方案。同样有利的是，分段地采用具有通向波状/曲线形状的上游和/或下游过渡部分的线性方案。同样证实有利地，在形成曲线形状时总是存在相同的曲率。其中在此情况下还应指出的是，通过长度来看逐渐增加的曲率或替代地逐渐减小的曲率可以是有利的。也可以想到将这些连接片绞合。
一个有利实施例的特征也在于，所述连接片和网目定义一个壁部，其以囊袋的方式构建。这样一来，在所述骨增量件/骨植入物上，例如在顶侧或底侧上，例如可以设有开口，以便容置填充物，如骨泥/骨碎片。
有利的是，所述基体具有10μm至700μm的孔洞/空穴。在孔隙率保持不变时，已证实平均延伸度为10μm至200μm的气泡是有效的。预设有所述囊袋，用于填装异质材料，如血液或骨碎片。
有利的是，所述连接片和网目在外侧被完全封闭或部分封闭的边缘包围。其中，所述边缘可以具有四周相同的厚度或者有所变化。边缘的存在简化了可操作性。最后，在植入物规划时，可以对植入物通道进行改性，例如在其壁部区域中，或者可以将所述植入物通道用作钻孔模板。在植入物规划时，也可以设置过矫正，即以某种方式设置，使得所述基体突出于所述缺陷，特别是在插入状态下，以便考虑到在愈合期间，与构建新的骨材料相比，更多的基体被分解。这一点达到了实现美观的解决方案的目的。这样就避免产生仅被皮肤覆盖但可以从外部视觉感知的凹点或凹部。
特别有利的是，这些连接片的厚度是两个交叉点之间的连接片的长度的四分之一到十分之一以及/或者这些连接片的横截面采用多边形或圆形或椭圆形的构建方案。特别是三角形、四边形和圆形的横截面已证实是有效的。就三角形横截面而言，等边三角形的形状已证实是特别有效的。
为特别好地确保对患者的最终护理，有利的是，在所述基体中设有至少一个(通孔/盲孔)植入物容置孔，用于容置植入物，如种植牙。这样就例如已经可以将种植牙安装在所述基体中，然后就可以在手术期间使用所述套件。当然，本发明还涉及将所述骨增量件插入所述骨中或将所述套件插入所述骨中/所述骨上。
有利的是，定义所述植入物容置孔的孔壁具有封闭/无孔的表面。因此，在此情况下，例如种植牙可以良好地保持在所述基体中。
在所述基体具有至少一个骨固定孔，即用于容置固定构件(如骨螺钉)的骨固定孔用来固定在骨上的情况下，则可以首先在所述骨增量件/所述骨植入物与骨之间实现良好的连接。随后的向内生长又增强了所述初始强度。
要指出的是，所述基体可以并且应该有利地由(单一)材料构成，所述材料例如是可生物降解的材料，如镁、镁合金、铁、铁合金、钡或锶，或者可吸收的聚合物、陶瓷材料或其复合材料，如PDLLA、PDLA、PLA、PGA、壳聚糖纤维/壳聚糖颗粒、HAP、CaCo3、α-/β-TCP、羟基磷灰石和/或双相磷酸钙(BCP)。当然也可以想到采用所述提及的材料的混合物。
最后，本发明还涉及所述由根据本发明类型的具有插入其中的植入物的骨增量件(如种植牙)构成的套件。本发明还涉及将所述根据本发明类型的骨增量件的连接作为钻孔模板。
本发明还涉及一种将根据本发明类型的骨增量件插入例如哺乳动物的骨骼，特别是人的骨骼上/中的医学方法。
换句话说，能够用异质材料(自身材料)实现形状稳定的附着和支撑。在此情况下，由于已经可以首先根据合适的牙植入物位置确定3D结构的形状和大小，因而能够实现合乎需要的处理方式。轮廓和容纳区域的改进得以实现。通过外轮廓的膜特性维持吸收保护。这一点避免了结缔组织的长入。避免了伤害解剖上的相邻结构，特别是相邻的牙齿、相邻的齿根以及特别重要的是下齿槽神经。这是因为可以在剩余骨部上使用预先规划的固定点，即在手术前精确地对手术进行周详计划。
使用并介绍了由骨替代材料(如HA、α-TCP、β-TCP、BCP、镁或镁钙锌合金)制成的实心的和/或多孔的、几何形状复杂且患者特定地制成的个体植入物。能够由骨替代材料(如HA、α-TCP、β-TCP、BCP、镁和MgCaZn)短时间制造多孔的、几何形状复杂且患者特定的个体植入装置。可以通过增加热量来实现所制成的植入物的强度增大。因此，由骨材料制造实心的和/或多孔的、几何形状复杂且患者特定地制成的个体植入物作为用于骨再生的可吸收的骨空腔填充物结构。由骨替代材料短时间/短期制造所述多孔的、几何形状复杂且患者特定的个体植入物是可行的。所述植入物可以由一种或多种材料，例如两种材料构成。
所有材料都可以以粉末形式、颗粒形式和液体至粘稠的形式使用，其中不同量和成分的材料可以彼此相互混合。
最后，要指出的是，所述骨增量件在外侧可以特别是以远侧突出的方式设有突出部、耳部、扩展部、舌片或板扩展区段，以便与邻接的骨材料重叠。在这些突出部中也可以设有孔洞，用以容置骨螺钉。在此情况下，可以实现所述骨增量件在骨上的无板连接。
下面结合附图对本发明进行详细说明。其中：
图1示出了具有设置在基体中的环绕式边缘的骨增量件的侧视图，在所述边缘的大量等距地相对彼此布置的连接片内部构建晶格结构，
图2示出了图1所示骨增量件的朝向骨的一侧的透视图，所示骨增量件具有用于装填位于植入物底侧上的骨泥/骨碎片的囊袋和位于上方的开口，
图3示出了所述增量件的无环绕式边缘的晶格结构，
图4示出了类似于图3的晶格结构，但具有环绕式边缘，
图5示出了如图2所示的囊袋的示意性结构，
图6示出了用作钻孔模板的骨增量件，以及
图7示出了借助所述骨增量件的预设的过矫正，及
图8示出了图1和2所示骨增量件在患者下颌中的使用状态。
这些附图本质上仅是示意性的。相同的元件采用相同的附图标记。各个实施例的特征可以彼此互换。
在本发明中，图1示出根据本发明的骨增量件1。所述骨增量件为骨植入物。其特别是适于在下颌中使用的骨植入物。稍作适应也可以将所述骨植入物用于上颌区域中。
借助图8已说明，所述骨增量件1填充骨3中的缺陷2。这个骨增量件1无缝/无隙地被插入所述缺陷2，所述缺陷2可以以盲孔或通孔的方式构建。在上述情况下，所述骨增量件1与骨头3的表面齐平。所述骨增量件1适于连续过渡到骨3中，也就是说，适于将这个骨增量件的表面和骨3的表面贴靠在内侧和外侧上。但是，如图7所示，也可以设有(在一个或两个面上)一个小的突起，其用附图标记4表示。
回到图1可以看出，所述骨增量件1具有由多个彼此交叉的连接片6构成的基体5。这些连接片6也可以被称为连铸坯。在这些连接片6之间有大量的空腔7，其定义网目8。
这些连接片6以桁架例如直角的方式相交叉，以便产生晶格结构。
如图2的替代性实施例所示，这些网目8并不一定是矩形的，也可以采用三角形构建方案。除这些连接片6和由它们所构成的网目8之外，所述基体5还具有封闭的边缘9。在上述情况下，该边缘9的厚度是连接片6的五倍以上。有利的是，所述边缘9的厚度是连接片6的11倍(+/-10至20％)。
在图1和2中，示例性地参考了交叉点10。
这些连接片6和由其所构成的网目8(如果存在所述边缘时，包括所述边缘9)定义一个壁部11或多个壁部11，囊袋12借助所述壁部11而构建。
值得注意的是，设有两个植入物容置孔13。此外，还具有骨固定孔14。在将另一植入物(例如种植牙)插入所述植入物容置孔13中并固定在骨3和/或所述基体5上时，可以在所述骨固定孔14中插入固定构件，如螺钉、夹板或螺栓，所述固定构件将基体5固定在骨3上。所述骨固定孔14可以至少部分地布置在所述植入物容置孔13内部或者甚至完全布置在所述植入物容置孔13内部。当然，也可以将这个骨固定孔布置在所述植入物容置孔外部。特别优选地，骨固定孔14部分地穿透定义植入物容置孔13的孔壁15。
图3和4示出了基体5的不同连接片布置方案，其中一次存在边缘9(参见图4)，一次缺少所述边缘9(图3)。
图5示出了具有基体5的骨增量件1，所述基体5以囊袋12的方式构建。其中，骨碎片或骨泥16被填入所述囊袋12。在此也可以添加血液制品。
图3示出插入骨3的缺陷2的骨增量件1。在此情况下可以看到，所述植入物容置孔13用于钻头17的强制方向预设，如此使得所述骨增量件1作为钻孔模板18起作用。进一步导入骨中的凹陷19用于供未绘示的种植牙穿过。
图7在横截面中示出了作为骨3的示例的下颌骨并且部分地在剖面中再现了所使用的根据本发明的骨增量件1。其中，存在突起4。该突起4与所述骨增量件1的余下部分一样在愈合过程中被患者身体分解，其中在愈合后，仅在也可以被定义为剩余区域20的剖面所示区域中设有骨自身材料，从而实现美观的结果。
附图标记列表
1 骨增量件
2 缺陷
3 骨
4 突起
5 基体
6 连接片
7 空腔
8 网目
9 边缘
10 交叉点
11 壁部
12 囊袋
13 植入物容置孔
14 骨固定孔
15 孔壁
16 骨泥/骨碎片
17 钻头
18 钻孔模板
19 凹陷
20 剩余区域

Claims (10)

1.一种用于填充骨(3)中的缺陷(2)的骨增量件(1)，其具有基体(5)，所述基体(5)适于无隙地被插入所述缺陷(2)，其特征在于，所述基体(5)具有由连接片(6)和空腔(7)构成的桁架状结构并且包含可生物降解的金属材料和/或可吸收的聚合物或陶瓷材料或者由此制成。
2.根据权利要求1所述的骨增量件(1)，其特征在于，多个连接片(6)相交叉并且在所述交叉点(10)上彼此相连。
3.根据权利要求1或2所述的骨增量件(1)，其特征在于，所述连接片(6)形成晶格结构，在所述晶格结构中，所述网目(8)中的大多数具有相同面积。
4.根据权利要求3所述的骨增量件(1)，其特征在于，所述网目(8)具有三角形或矩形形状。
5.根据权利要求1至4中任一项所述的骨增量件(1)，其特征在于，所述连接片(6)在其几何形状和/或所述材料特性方面采用相同方案。
6.根据权利要求1至5中任一项所述的骨增量件(1)，其特征在于，所述连接片(6)采用线性/直线或波状或曲线的构建方案。
7.根据权利要求1至6中任一项所述的骨增量件(1)，其特征在于，所述连接片(6)和网目(8)定义一个壁部(11)，其以囊袋(12)的方式构建。
8.根据权利要求1至7中任一项所述的骨增量件(1)，其特征在于，所述连接片(6)和网目(8)在外侧被边缘(9)包围。
9.一种由根据上述权利要求中任一项所述的具有插入其中的植入物的骨增量件(1)构成的套件。
10.一种将根据上述权利要求中任一项所述的骨增量件(1)作为钻孔模板(18)的应用。
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WO2019011915A1 (de) 2019-01-17
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AU2018299930A1 (en) 2020-01-30
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ES2894755T3 (es) 2022-02-15
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