CN113423442A - 引导骨再生装置及制造方法 - Google Patents
引导骨再生装置及制造方法 Download PDFInfo
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Abstract
本发明涉及一种用于口腔骨缺损重建的引导骨再生装置,所述装置由二氧化锆构成并且具有可以覆盖所述口腔骨缺损的形状。本发明还涉及本发明装置的一种制造方法,包括的步骤是:通过骨缺损牙颌成像技术获得3D成像,根据所得3D成像来构建本发明的装置。
Description
技术领域
本发明涉及一种用于口腔骨缺损重建的引导骨再生装置,以及这种装置的制造方法。
因此,本发明可应用于医学领域,特别是牙外科领域。
在下面的描述中,方括号([])中的标号是指本文末尾列出的参考文献列表。
背景技术
为了使骨损失造成的损坏和/或失去的组织再生,已有多种骨增量技术,例如对位移植、插入移植、扩张、牵引、窦移植或引导骨再生(GBR)。
GBR的目的是重建骨骼,以便能够置入和/或稳定牙种植体,或者为不可移动的假体重建牙槽嵴。一般地,在可以使用种植体或置入不可移动的假体之前,将膜体在骨骼和牙龈之间放置3到6个月。所使用的膜体形成物理屏障,一方面可以防止结缔组织和上皮软组织侵占骨缺损处,另一方面可以仅限具有成骨能力的细胞进入瘢痕空间。因此,这些膜体具有三重作用:防止细胞在覆盖粘膜处增殖,促进细胞从髓质空间迁移到位于该部位的凝块中,稳定骨移植物和凝块以及稳定生物材料填充物。
因此,使用了几类可吸收或不可吸收膜,例如由聚四氟乙烯(PTFE)或可吸收胶原制成的膜。不可吸收膜的特征主要是生物惰性、柔韧性、化学稳定性和不对称微孔性。但是,它们需要通过骨钉固定并且需要第二次手术来移除。
相反,可吸收膜具有骨再生后无需取出的优点,这避免了取出时可能发生的潜在组织刺激,如果该膜体在愈合阶段与周围组织连结的话。然而,可吸收膜的缺点是可能会干扰吸收/愈合和骨再生,并且需要膜支撑材料。
因此,确实需要克服这些缺陷的装置,特别是能够实现重建的最佳建模以及骨结构拟态和对称性的装置。
发明内容
发明人设计出了一种满足这些目的的装置。
实际上,本发明的装置可以增加竖直和水平方向的骨量,从而可以填充骨缺损,实现重建的最佳建模以及骨结构拟态和对称性。
因此,本发明的第一个目的涉及一种用于骨缺损重建的引导骨再生装置。它由二氧化锆(ZrO2)构成并且具有可以覆盖所述口腔骨缺损的形状。
有利地,本发明的装置具有三维形状,至少部分地,优选完全地覆盖骨缺损。因此,在骨重建之后,重建体积可以与由于受治骨损失的体积基本相同,甚至更大。
为了获得三维形状以覆盖需要治疗的骨缺损形状,可以针对需要重建的骨体积和/或骨量采用任何建模技术。可以是骨缺损牙颌成像技术,例如锥形束体积断层扫描(也称为Cone beam)。有利地,可以利用适于对需要再生的骨物质进行量化的软件,例如MIMICS或3-matic(该列举并非详尽无遗),对骨缺损进行数字化显示。
因此本发明的装置是根据建模形状制造的,以便通过本领域技术人员已知的任何适用技术来模拟3D设计,例如通过模制、机械加工或3D打印。可选地,参照图示,在构建本发明的装置之前,可以在3D成像时增加1mm厚的附加层,以有利地补偿在某些再生情况中可能发生的表面上皮形成。
有利地,本发明的装置具有适当的三维形状,使其可以覆盖全部或部分骨缺损,并且可以在必要时重建损失的全部骨体积。有利地,无论选择何种形状,该装置在其安装期间会在其壁体和残余骨之间留下中空空间,从而可以向本发明的装置内部导入生物材料。本领域技术人员可以采用任何能够实现该目的的形状。例如可以是选自贝壳形、刚性板、壳状和网状(也称为mesh)的形状。
如上所述,本发明的装置由二氧化锆(也称为锆石或氧化锆)构成。该装置中二氧化锆的含量可以例如在88%到96%之间,例如88%、或89%、或90%、或91%、或92%、或93%、或94%、或95%、或96%。有利地,可以存在至少一种通常存在于此类陶瓷中的其他成分,例如氧化钇、氧化铪和/或氧化铝。例如,氧化钇的含量最高可达4-6%,氧化铪的含量最高可达1-5%,氧化铝的含量最高可达0-1%。可以是例如市售组合物,如ZfxTM氧化锆(ZfxGmbH,德国)。有利地,二氧化锆因其已知的物理特性而用于本发明的装置,例如其耐碎耐裂、高度生物相容性、中性和极少诱发炎症。有利地,氧化锆构成细胞和组织屏障。此外,它有利地是不可骨整合的,并且易于取出。由于本发明装置的特征,移植物有利地得到稳定和压缩,并且呈现出几乎为零的吸收水平。
有利地,本发明的装置可以包含至少一个用于稳定该装置的贯穿孔,每个贯穿孔用于容纳接骨螺钉。因此,在该装置的前庭壁上形成的一个或多个贯穿孔。贯穿孔的数量可以根据该领域应用的常规标准来确定,例如根据骨缺损的大小。因此贯穿孔的数量可以在1到4个之间,甚至1到20个,甚至更多,这取决于需求以及需要重建的体积。
有利地,该装置的全部或部分壁体上还可以包含微贯穿孔。微贯穿孔可以均匀地或不规则地分布在所述壁体上。微贯穿孔的直径可以在1μm到1mm之间,优选地不包括1mm,例如2μm到800μm,或5μm到500μm,或10μm到300μm。壁体上的微贯穿孔密度可以是每平方厘米1到100个微贯穿孔,例如在20到90个,或者30到80个。这些孔通常是圆形的,但也可以是与其功能相容的任何其他形状,例如方形、椭圆形或矩形。有利地,微贯穿孔可以在组织再生期间改善血管生成。事实上,新生血管除了经过需要增量的天然骨或天然骨嵴进入生物材料以外,微贯穿孔还可以使新生血管从软组织进入生物材料。微贯穿孔还可以改善软组织对氧化锆板的附着力,从而避免缝合区域的张力并减少装置的初始和后期暴露。微贯穿孔可以通过本领域技术人员已知的任何方法或工具形成,例如通过细钻或激光。
有利地,本发明的装置可以包含至少一个设置在其壁体中的窗口,尤其用于插入生物材料并使其凝结。生物材料一旦插入到骨和本发明装置的壁体之间,即需要重建的空间中,将可以产生骨诱导并因此使预期骨骼重建。在这种情况下可以使用适于骨重建的任何类型生物材料,如选自同种、异种、自体和合成骨替代物的各种类型的骨替代物,该列举并非详尽无遗。窗口的尺寸、形状和数量可由本领域技术人员进行选择,尤其是根据本发明装置的尺寸以及需要治疗的骨缺损的性质。例如,窗口可以是方形、圆形、椭圆形或矩形的。例如,它可以刻在高1到20mm、宽1到30mm或更大的矩形内。窗口可以通过本领域技术人员已知的任何合适的技术来设计,例如通过3D设计器。窗口数量可以在1到5之间,例如可以是1、2、3、4或5。然而,本领域技术人员可以根据需要调整窗口的数量。一个或多个窗口可以通过固定装置进行固定,例如接骨螺钉、线、齿轮甚至嵌合槽。有利地,窗口的功能是可以使装置形成的腔室或空间被生物材料所填充,以及在形成和固定窗口时使生物材料压实。
该装置可以具有与其功能相适应的厚度,也就是说,可以在骨重建所需的时间内保护生物材料。因此,本领域技术人员可以根据情况方便地确定合适的厚度。例如,本发明装置的厚度可以在0.1mm到2.5mm之间,例如大约为0.1mm、或0.2mm、或0.3mm、或0.4mm、或0.5mm、或0.6mm、或0.7mm、或0.8mm、或0.9mm、或1.0mm、或1.1mm、或1.2mm、或1.3mm、或1.4mm、或1.5mm、或1.6mm、或1.7mm、或1.8mm、或1.9mm、或2.0mm、或2.1mm、或2.2mm、或2.3mm、或2.4mm、或2.5mm。
有利地,一旦达到骨重建所需的暴露时间,本发明的装置易于取出。事实上,由于该装置从外部覆盖了需要重建的体积,因此只需取下骨螺钉就足以将其拆除。
有利地,本发明的装置还可以可任选地包含位于牙槽嵴处的贯穿孔,以便可以在引导骨再生外科手术步骤中插入牙种植物。
本发明的另一个目的涉及一种如上定义的本发明装置的制造方法。所实施的方法尤其可以包括的步骤是:通过牙颌成像技术,例如通过锥形束体积断层扫描(也称为Conebeam)获得骨缺损的3D成像,根据此3D成像来构建所述装置。
有利地,并且如上所述,骨缺损3D成像可以利用适于对需要再生的骨物质进行量化的软件进行数字化显示。
可选地,数字显示可以获得图示,从而根据该图示来制造本发明的装置,以覆盖骨缺损3D成像。可选地,可以增加1mm厚的附加层,以增加需要覆盖的体积并获得较大的重建体积,并且补偿表面上皮的形成。
本发明的另一个目的涉及一种骨再生方法,包括以下步骤:
-将根据本发明的装置放置在患者骨缺损处,
-将生物材料导入到该装置中,
-将该装置放置足够时间,以使生物材料凝结,
-取出本发明的装置。
通过下面的作为示例给出的实施例,并结合附图,本领域技术人员将更好地理解其他优点。
附图说明
图1示出了用3D成像呈现的骨体积重建。A:需要重建的体积的正视图。B:需要重建的体积的俯视图。C:需要重建的体积的仰视图。
-图2示出了清洁及通过镜面效应确定填充体积后,需要重建的骨体积的视图。A:需要重建的体积的正视图。B:需要重建的体积的俯视图。C:需要重建的体积的仰视图。
-图3示出了厚度0.8mm的壳体的视图,在需要填充的体积上方有1mm的偏移。A:需要重建的体积的正视图。B:需要重建的体积的俯视图。C:需要重建的体积的正视图。
-图4示出了覆盖需要重建的骨体积的壳体的剖视图。
-图5示出了壳体的正视图,包括高6mm,宽5.5mm的窗口和两个直径1.4mm的固定孔。
具体实施方式
实施例1:贝壳形引导骨再生装置的制备
通过锥形束体积断层扫描(Cone beam)对需要重建的骨量体积进行建模。
利用可以量化需要再生的骨物质的MIMICS/3-matic软件,对骨缺损重建的3D成像可以进行数字化显示。
利用该图示,在3D成像时增加1mm厚的“可选”附加层,然后设计0.6到1.8mm厚的贝壳形,以覆盖所述3D设计。
设计贯穿孔,以便利用接骨螺钉来稳定将来的氧化锆贝壳形。
贝壳形图示经过验证后,通过3D打印机在氧化锆上打印该贝壳形。
实施例2:引导骨再生装置的实施示例
术前向患者开具处方药:阿莫西林克拉维酸(每日2g)、泼尼松龙(每日60mg)。
手术后开具对乙酰氨基酚/可待因和漱口水(0.12chlorexidine)。
放置网状/壳状氧化锆。经由现有外壳上的孔进行穿孔。将两个接骨螺钉部分拧入,然后将同种异体生物材料置于壳体下方。拧紧螺钉以确保生物材料的稳定性。实施无张力的边对边缝合。
Claims (11)
1.一种用于口腔骨缺损重建的引导骨再生装置,所述装置由二氧化锆构成并且具有可以覆盖所述口腔骨缺损的形状。
2.根据权利要求1所述的装置,其特征在于,所述装置还包含至少一种选自氧化钇、氧化铪和氧化铝的其他成分。
3.根据权利要求1或2中任一项所述的装置,其特征在于,所述装置具有选自贝壳形、平板和网状的形状。
4.根据上述权利要求中任一项所述的装置,包含至少一个用于稳定所述装置的贯穿孔,所述贯穿孔用于容纳接骨螺钉。
5.根据上述权利要求中任一项所述的装置,在其全部或部分壁体上包含微贯穿孔。
6.根据上述权利要求中任一项所述的装置,包括至少一个窗口。
7.根据上述权利要求中任一项所述的装置,厚度在0.6mm到1.8mm之间。
8.一种制造如权利要求1至7中任一项所述的装置的方法,包括的步骤是:通过骨缺损牙颌成像技术获得3D成像,根据所得3D成像来构建所述装置。
9.根据权利要求8所述的方法,其中所述骨缺损的所述3D成像利用适于对需要再生的骨物质进行量化的软件进行数字化显示。
10.根据权利要求8或9中任一项所述的方法,其中所述医学影像技术是锥形束体积断层扫描技术(Cone beam)。
11.根据权利要求8至10中任一项所述的方法,其中所述数字显示可以获得上面增加了1mm厚的可选附加层的图示。
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KR102397547B1 (ko) | 2022-05-13 |
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CY1124382T1 (el) | 2022-07-22 |
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MA53775A1 (fr) | 2022-07-29 |
PT3669902T (pt) | 2021-07-30 |
US11951230B2 (en) | 2024-04-09 |
BR112021012043B1 (pt) | 2022-03-22 |
US20220040372A1 (en) | 2022-02-10 |
CA3124169A1 (fr) | 2020-06-25 |
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MA53775B1 (fr) | 2023-03-31 |
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