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CN117999049A - 骨修复器件和手术用套件 - Google Patents

骨修复器件和手术用套件 Download PDF

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Publication number
CN117999049A
CN117999049A CN202280064911.3A CN202280064911A CN117999049A CN 117999049 A CN117999049 A CN 117999049A CN 202280064911 A CN202280064911 A CN 202280064911A CN 117999049 A CN117999049 A CN 117999049A
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Prior art keywords
nonwoven fabric
stem cells
repair device
bone repair
implant
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藤田顺之
堀秀生
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Fujita Health University
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Fujita Health University
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Abstract

骨修复器件(1)包括：椎间笼(11)，在内部设置有能够从外部流入体液的空间；以及无纺布(12)，收纳于椎间笼(11)的空间，附着有干细胞或从干细胞分化的成骨细胞。干细胞可以是从植入有椎间笼(11)的患者采集的间充质干细胞。无纺布(12)的纤维直径可以是0.1μm～30μm的范围内。无纺布(12)的纤维密度可以是0.2g/m2～150g/m2的范围内。

Description

骨修复器件和手术用套件
技术领域
本发明涉及骨修复器件和手术用套件。
背景技术
为了治疗脊柱管狭窄症、脊椎滑脱症，广泛进行后方椎体间固定术。在后方椎体间固定术中，清除椎间盘，在清除了椎间盘的部位插入被称为椎间笼的植入物，使用螺钉及杆将相邻的椎体彼此固定，由此消除脊柱管的狭窄。为了在术后确保椎体间的稳定性，需要相邻的椎体与椎间笼牢固地愈合，对椎间笼实施了为此的研究。例如，在专利文献1中，公开了形成有收纳人体骨片的孔的椎间笼。
在先技术文献
专利文献1：日本特开2012-19919号公报。
发明内容
发明要解决的问题
在专利文献1的椎间笼中，在通过基于骨片的骨修复的作用而与相邻的椎体进行愈合之前，需要一定程度的治疗期间。因此，为了实现患者的早期的社会恢复，期望进一步缩短治疗期间。而且，这样的问题不限于相邻的椎体与椎间笼愈合的情况，也存在于在其他部位进行骨的修复的情况。
本发明是基于这样的背景而完成的，其目的在于提供一种促进骨的修复的骨修复器件和手术用套件。
解决问题的手段
为了实现上述目的，本发明的第一观点的骨修复器件包括：
植入物，在内部设置有能够从外部流入体液的空间；以及
无纺布，收纳于所述植入物的所述空间，附着有干细胞或从所述干细胞分化的成骨细胞。
所述干细胞可以是从植入有所述植入物的患者采集的间充质干细胞。
所述无纺布的纤维直径可以是0.1μm～30μm的范围内。
所述无纺布的纤维密度可以是0.2g/m2～150g/m2的范围内。
所述无纺布可以由至少包含聚乳酸、聚乙醇酸、丝心蛋白、聚-ε-己内酯、甲壳素和壳聚糖中任一个的材料形成。
所述骨修复器件还可以包括骨片，所述骨片与所述无纺布一起收纳在所述植入物的所述空间内。
所述植入物可以包括：
主体，在内部形成有所述空间；以及
贯通孔，设置于所述主体，从所述主体的表面朝向所述空间贯通，使体液流入所述空间内。
所述植入物可以是在椎间盘被清除的一对椎体之间插入的椎间笼为了实现上述目的，本发明的第二观点的手术用套件包括：
植入物，在内部设置有能够从外部流入体液的空间；以及
无纺布封装，能够收纳于所述植入物的所述空间，包含在附着有干细胞或从所述干细胞分化的成骨细胞的状态下被包装的无纺布。
发明效果
根据本发明，能够提供促进骨修复的骨修复器件和手术用套件。
附图说明
图1A是示出本发明的实施方式的骨修复器件的结构的俯视图。
图1B是示出本发明的实施方式的骨修复器件的结构的主视图。
图2A是示出脊椎的解剖学的结构的概略图。
图2B是示出将本发明的实施方式的骨修复器件埋设于一对椎体之间的情形的概略图。
图3是利用扫描型电子显微镜拍摄本发明的实施方式的无纺布的一个示例的图。
图4是示出使间充质干细胞附着于本发明的实施方式的无纺布的步骤的图。
具体实施方式
以下，参照附图详细说明本发明的实施方式的骨修复器件和手术用套件。在各附图中，对相同或同等的部分标注相同的符号。
骨修复器件是埋设于骨缺损部并承受来自骨缺损部的载荷的同时促进骨缺损部中的骨的修复的器具。以下，以将骨修复器件埋设于在后方椎体间固定术中椎间盘被清除的缺损部的情况为例进行说明，但骨修复器件能够根据骨缺损部的形态以各种形状、大小形成。
骨缺损部是在体内的骨、软骨中产生的缺损，例如不仅包含人为地去除了骨、软骨的部位，还包含因骨折部位、软骨的损伤部位、其他骨的疾病而产生的缺损部位。另外，在骨的修复中，不仅包括使原本存在于骨缺损部的骨组织、功能复原，还包括将骨缺损部的全部或一部分用人工物替换、或使本来存在于骨缺损部的功能的一部分恢复的情况。
图1A及图1B分别是示出本发明的实施方式的骨修复器件1的结构的俯视图、主视图。骨修复器件1包括：椎间笼11，其插入到通过后方椎体间固定术摘除椎间盘的相邻的椎体间；以及无纺布12，其收纳于椎间笼11内，附着有间充质干细胞或从间充质干细胞分化的成骨细胞。
椎间笼11是埋设于体内的植入物的一个示例，是安装于相邻的两个椎骨的椎体之间，接收来自椎体的载荷的轿厢状的器具。椎间笼11由具有生物体相容性的材料、例如钛或钛合金之类的金属材料形成。椎间笼11例如通过对块状的实心材料实施加工而形成，具有即使在相邻的椎体之间受到载荷也不变形的程度的刚性。另外，也可以在椎间笼11的上面部和下面部形成例如由槽或突起构成的防滑部，以使椎间笼11不会从椎体间滑落。
椎间笼11包括：收纳孔11a，其在上面部以及下面部开口，收纳无纺布12；以及多个细孔11b，其从侧面部朝向收纳孔11a延伸。收纳孔11a是收纳无纺布12的空间的一个示例，例如在俯视时形成为椭圆形或长圆形。细孔11b是贯通孔的一个示例，以将包含细胞、营养素的体液均匀地供给到收纳于收纳孔11a的无纺布12的方式，在侧面部隔开间隔地设置有多个。在图1B的背面侧，也与表面侧同样地设置有多个细孔11b。
椎间笼11的前端部具备带有圆角的形状以将其推入相邻的椎体间。另一方面，在椎间笼11的基端部形成有能够安装长条的安装夹具的安装槽11c。手术者操作安装夹具，将椎间笼11压入图2A所示的去除了椎间盘的相邻的椎体间的间隙，由此，如图2B所示，骨修复器件1的椎间笼11埋设于相邻的椎体间。
图3是利用扫描型电子显微镜拍摄实施方式的无纺布12的一个示例的图。无纺布12是将细径的纤维不编织而缠绕的片，能够使间充质干细胞附着于各纤维。无纺布12能够任意地变形，因此适合收纳于椎间笼11的内部。
在无纺布12中，调整其纤维直径和纤维密度，以使得间充质干细胞附着于一个一个的纤维，并且细胞悬液、体液流入纤维之间的空间。为了使细胞附着于纤维，使无纺布12的纤维直径变细即可。另一方面，若使无纺布12的纤维直径过细，则强度变弱，若纤维密度过大，则细胞堵塞，其处理有可能变得困难。若考虑间充质干细胞的附着性及无纺布12的制造的容易性，则无纺布12的纤维直径优选为0.1μm～30μm的范围内，更进一步优选为0.1μm～3μm的范围内。另外，无纺布12的纤维密度为0.2g/m2～150g/m2的范围内。
无纺布12由生物体吸收性材料、例如聚乳酸、聚乙醇酸、聚乙二醇、丝心蛋白、聚-ε-己内酯、甲壳素、壳聚糖、聚乳酸和聚乙醇酸的共聚物、聚乳酸和聚乙二醇的共聚物、或者它们的2个以上的组合形成。从促进间充质干细胞中的生长因子的产生的观点出发，无纺布12优选由聚乳酸、丝心蛋白、聚ε己内酯、甲壳素或壳聚糖形成。
间充质干细胞是具有向属于间充质的细胞的分化能力的成体干细胞。作为附着于无纺布12的间充质干细胞，选择通过产生成骨细胞的生长因子而促进骨缺损部中的成骨细胞的生长、或能够分化而得到成骨细胞的干细胞。附着于无纺布12的间充质干细胞只要满足上述条件，则可以为源自脂肪、源自骨膜、源自滑膜、源自海绵骨、源自骨髓、源自羊膜、源自脐带血、源自胎盘的任一种。另外，也可以使多种间充质干细胞一起附着于无纺布12。
附着于无纺布12的间充质干细胞可以在体外培养从患者采集的干细胞。为了在体外培养间充质干细胞，例如可以使用包含胎牛血清(Fetal Bovine Serum：FBS)或人血清、优选来自患者的人血清的培养基或无血清培养基。在培养基中培养的间充质干细胞可以直接附着于无纺布12，也可以使间充质干细胞分化而表达成骨细胞后附着于无纺布12。为了表达成骨细胞，例如在间充质干细胞的培养基中添加分化诱导因子即可。
为了使间充质干细胞附着于无纺布12，只要使包含间充质干细胞的细胞混浊液在一段时间内与无纺布接触即可。以下，参照图4，对使间充质干细胞附着于无纺布的具体的步骤进行说明。
首先，在构成过滤装置的一对支架之间安装无纺布12。各支架构成为能够使细胞混浊液流出或流入。通过用一对支架夹持无纺布12，在使细胞悬浮液从一个支架朝向另一个支架流动时，细胞混浊液与无纺布12接触。另外，一对支架夹持的无纺布12也可以是多片。
接着，使含有间充质干细胞的细胞混浊液从上方缓慢地滴加，用无纺布12对细胞混浊液进行过滤。于是，间充质干细胞逐渐附着于无纺布12的纤维。严密的机理尚不明确，但若将含有间充质干细胞的细胞混浊液花费时间过滤至无纺布12，则附着于无纺布12的间充质干细胞活化。
另外，如果间充质干细胞附着于无纺布12，则能够期待从间充质干细胞产生具有骨组织的修复作用的生长因子，因此不一定需要通过图4所示的步骤使间充质干细胞活化。
以下，对实施方式的骨修复器件1的制造方法进行说明。首先，获得附着有间充质干细胞的无纺布12。为了获得附着有间充质干细胞的无纺布12，例如可以事先培养从患者或患者以外的人体采集的间充质干细胞，使其附着于无纺布12。无纺布12可以在附着间充质干细胞前后的任一时刻切断成适于椎间笼11的尺寸。
附着有间充质干细胞的无纺布12可以直接收纳于椎间笼11的内部，也可以作为由包装材料包装的无纺布封装而保管。包含在附着有干细胞的状态下包装的无纺布12的无纺布封装也可以与椎间笼11一起作为手术用套件而提供给手术者。
接着，将附着有间充质干细胞的无纺布12收纳在椎间笼11内。例如，用镊子把持无纺布12，以在椎间笼11内不产生无纺布12的偏移的方式压入椎间笼11内即可。此外，收纳有无纺布12的椎间笼11可以直接植入相邻的椎体间，也可以在包装收纳有无纺布12的椎间笼11之后保管至手术。
以上是骨修复器件1的制造方法的流程。
以下，对手术者使用实施方式的骨修复器件1执行的后方椎体间固定术的步骤进行说明。首先，手术者切开对象部位的皮肤，从切开部将脊椎后方组织的两侧展开，如图2A所示，将螺钉分别插入到沿上下方向上排列配置的多个椎弓根。接着，实施解除对脊椎神经的压迫的减压。接着，从一侧或两侧去除椎间盘，取而代之，如图2B所示，埋设一个或两个骨修复器件1。接着，将沿上下方向配置的杆固定于被插入到多个椎弓根的多个螺钉，从背侧固定脊椎。接着，缝合皮肤而闭合切开部。
以上是后方椎体间固定术的一系列的步骤。
在通过后方椎体间固定术埋设于相邻的椎体间的骨修复器件1中，由于在椎间笼11的收纳孔11a中收纳有无纺布12，因此通过附着于无纺布12的间充质干细胞或成骨细胞的作用，以无纺布12为立足点而促进成骨细胞的增殖、生长。其结果，与未收纳无纺布12的椎间笼相比，能够将相邻的椎体彼此早期地固定，能够实现脊椎的早期的修复。
如以上说明的那样，实施方式的骨修复器件1包括：椎间笼11，其在内部设置有能够从外部流入体液的空间；以及无纺布12，其收纳于椎间笼11的空间，附着有间充质干细胞或从间充质干细胞分化的成骨细胞。因此，能够实现骨缺损部的早期的修复。
本发明不限于上述实施方式，还能够进行以下所述的变形。
(变形例)
在上述实施方式中，椎间笼11具备收纳孔11a及细孔11b，但本发明不限于此。椎间笼11只要在内部设置有能够从外部流入体液的空间，则可以是任何形状。
在上述实施方式中，椎间笼11由金属材料形成，但本发明不限于此。例如，可以是聚醚醚酮(Poly Ether Ether Ketone：PEEK)之类的树脂材料，也可以是纤维增强塑料、陶瓷、人工骨。
在上述实施方式中，为了促进骨修复而使间充质干细胞附着于无纺布12，但本发明不限于此。附着于无纺布12的干细胞例如可以是胚胎干(Embryonic Stem：ES)细胞、诱导性多功能干(induced Pluripotent Stem：iPS)细胞。
在上述实施方式中，将附着有间充质细胞的无纺布12直接收纳在椎间笼11内，但本发明不限于此。例如，也可以在附着有间充质细胞的无纺布12中加入凝胶化剂来使用。作为胶凝剂，例如使用胶原、明胶、细胞外基质混合物、纤维蛋白、多糖类、软骨素即可。作为细胞外基质混合物，例如使用康宁公司制的Matrigel(注册商标)即可，作为多糖类，例如使用琼脂糖即可。
在上述实施方式中，在椎间笼11的内部收纳了附着有间充质干细胞的无纺布12，但本发明不限于此。例如，除了无纺布12之外，也可以一起收纳从人体采集的骨片。骨片是将从人体采集的骨粉碎而成的，优选将从患者自身采集的骨(局部骨或髂骨)粉碎而成。骨片的形状、尺寸是考虑椎间笼11的形状、尺寸、椎间笼11的埋设部位而设定的。为了避免骨片在体内分散，也可以将骨片用无纺布12包裹并收纳在椎间笼11的内部。另外，也可以在将无纺布12收纳于椎间笼11的内部之前或收纳后的时间点，使无纺布12保持促进骨修复或抑制免疫反应的药剂。
在上述实施方式中，以在相邻的椎体间的缺损部埋设椎间笼11的情况为例进行了说明，但本发明不限于此。植入物不限于椎间笼11，只要在内部设置有能够从外部流入体液的空间，则也可以是能够应用于其他部位的植入物。例如，为了在长管骨的切骨术中将骨与骨接合，也可以在骨与骨之间埋设将附着有间充质干细胞的无纺布收纳于内部的植入物。
上述实施方式是例示，本发明并不限定于这些，在不脱离权利要求书所记载的发明的主旨的范围内能够进行各种实施方式。实施方式、变形例中记载的构成要素能够自由地组合。另外，与权利要求书中记载的发明同等的发明也包含在本发明中。
本申请基于2021年9月27日申请的日本专利申请2021-156438号，包括其说明书、权利要求书、附图和摘要。上述日本专利申请中公开的全部内容作为参照包含在本说明书中。
工业应用性
本发明的骨修复器件和手术用套件对促进骨的修复是有用的。
符号说明
1：骨修复器件；
11：椎间笼；
11a：收纳孔；
11b：细孔；
11c：安装槽；
12：无纺布。

Claims (9)

1.一种骨修复器件，包括：
植入物，在内部设置有能够从外部流入体液的空间；以及
无纺布，收纳于所述植入物的所述空间，附着有干细胞或从所述干细胞分化的成骨细胞。
2.根据权利要求1所述的骨修复器件，其中，
所述干细胞是从植入有所述植入物的患者采集的间充质干细胞。
3.根据权利要求1或2所述的骨修复器件，其中，
所述无纺布的纤维直径为0.1μm～30μm的范围内。
4.根据权利要求1至3中任一项所述的骨修复器件，其中，
所述无纺布的纤维密度为0.2g/m2～150g/m2的范围内。
5.根据权利要求1至4中任一项所述的骨修复器件，其中，
所述无纺布由至少包含聚乳酸、聚乙醇酸、丝心蛋白、聚-ε-己内酯、甲壳素和壳聚糖中任一个的材料形成。
6.根据权利要求1至5中任一项所述的骨修复器件，其中，
所述骨修复器件还包括骨片，所述骨片与所述无纺布一起收纳在所述植入物的所述空间内。
7.根据权利要求1至6中任一项所述的骨修复器件，其中，
所述植入物包括：
主体，在内部形成有所述空间；以及
贯通孔，设置于所述主体，从所述主体的表面朝向所述空间贯通，使体液流入所述空间内。
8.根据权利要求1至7中任一项所述的骨修复器件，其中，
所述植入物是在椎间盘被清除的一对椎体之间插入的椎间笼。
9.一种手术用套件，包括：
植入物，在内部设置有能够从外部流入体液的空间；以及
无纺布封装，能够收纳于所述植入物的所述空间，包含在附着有干细胞或从所述干细胞分化的成骨细胞的状态下被包装的无纺布。
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