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CN111867515A - 基于钛线和生物可吸收聚合物的自固定网状植入物 - Google Patents

基于钛线和生物可吸收聚合物的自固定网状植入物 Download PDF

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CN111867515A
CN111867515A CN201880091158.0A CN201880091158A CN111867515A CN 111867515 A CN111867515 A CN 111867515A CN 201880091158 A CN201880091158 A CN 201880091158A CN 111867515 A CN111867515 A CN 111867515A
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mesh
self
implant
fixating
titanium
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CN111867515B (zh
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A·A·卡赞采夫
A·A·尤苏波夫
A·I·阿列恒
V·A·扎瓦列夫
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Titanium Textiles AG
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Elastic Titanium Implants LLC
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Abstract

本发明涉及医学和医疗技术的领域，目的在于改善用于疝修补术的技术网状植入物。一种自固定网状植入物由两层组成，上层和下层，基于钛线的网状层在上侧，生物可吸收聚合物层在下侧，其中钛线表面制成凹凸状。技术效果包括提高手术领域中固定植入物的效率，提高可塑性并降低植入物线破损风险，使固定简单化并提高固定的强度，保证植入物整个表面均匀固定在手术伤口的组织上，缩短手术持续时间，并且，作为结果，减少了麻醉剂量和创口体积，从而降低并发症的发生率。

Description

基于钛线和生物可吸收聚合物的自固定网状植入物
技术领域
本发明涉及医学和医疗技术的领域，目的在于改善用于疝修补术的技术网状植入物。
背景技术
现有技术中有已知的方案(RU 12i1735 U1，公开日2012年11月10)，其描述了用于重建性外科手术的网状植入物。该网状植入物具有钛含量至少80％的钛合金丝制成的丝网，其中丝网含有弯曲成彼此连接的环形的丝。丝网用中断的U-形缝线固定在边缘或沿着周界用连续缝线固定。如果需要将丝网最牢固的固定于组织上，那么可沿着疝口的边缘应用第二周界缝线。还可以用钛支架固定丝网。
该技术方案的缺点是当固定网状植入物时，以各种方式或原料制成的缝线形式来使用额外的固定架。该方案不能快速牢固固定植入物并将其整个表面均匀固定在外科伤口。
现有技术中有已知的方案(RU 160627 U1，公开日2016年3月27日)，其描述了用于疝修补术的网状材料。具有生物活性涂层由钛线制成的网状物用中断的U-形缝线固定在边缘或沿着周界用连续缝线固定。如果需要将网状物最牢固的固定于组织上，那么可沿着疝口的边缘应用第二周界缝线。
该技术方案以及上述技术方案的缺点是当固定网状植入物时，以各种方式或原料制成的缝线形式来使用额外的固定架。该方案不能快速牢固固定植入物并将其整个表面均匀固定在外科伤口；线不具备高可塑性并且有很高破损风险。
本发明能够基本上克服原型内在所述缺点。
发明内容
提出的技术方案解决的技术问题是研发手术领域中不需额外固定架(缝合材料、钉、锚和胶)可即刻固定的网状钛植入物。
技术效果包括提高手术领域中固定植入物的效率，使固定简单化并提高固定的强度，保证植入物整个表面均匀固定在手术伤口的组织上，提高可塑性并降低植入物线破损风险，缩短手术持续时间，并且，作为结果，减少了麻醉剂量和创口体积，从而降低并发症的发生率并且使患者快速康复。
技术效果得以实现，归因于如下事实：自固定网状植入物由两层组成，上层和下层，基于钛线的网状层在上侧，生物可吸收聚合物层在下侧，其中钛线表面制成凹凸状(relief)。
钛线采用5级合金制成。
钛线的表面凹凸以从0.00025mm开始波动的不均匀钛线直径制成。
凹凸钛线的表面涂覆有氧化膜。
钛线厚度是15-120μm。
钛网的表面密度是20-80g/m2。
网格尺寸是0.1-2mm。
下层采用选自聚乳酸的生物可吸收聚合物制成。
生物可吸收聚合物以直径是0.2-1mm的滴状物形式存在，位于整个下层表面。
生物可吸收聚合物的下层含有至少一种药物。
附图说明
图1.网状植入物；
图2.植入物横截面的示意图；
图3a.凹凸线制成的网状织物中交叉环系列的状态；
图3b.无凹凸的线制成的网状织物中交叉环系列的状态；
图4.编织的网状物的张力的零刚度图；
图5a.化学蚀刻之后线表面凹凸的实例；
图5b.离子处理之后线表面凹凸的实例；
图6a.处理之前有纵向尖锐缺陷的线的横截面；
图6b.处理之后有平滑的纵向缺陷的线的横截面。
具体实施方式
本发明的基础在于使用生物可吸收聚合物作为钛线制成的网状植入物的固定架。
自固定网状植入物1由两层2和3组成，其中基于钛线的网状物制成的层2在上侧，生物可吸收聚合物制成的层3在下侧。
上层2由纬编或经编网状物表示，它可由合金VT1-00、VT-1.00wa(1级)或VT6(5级)的钛线按线厚度15-120μm制成。网状物表面密度是20-80g/m2，网格尺寸0.1-2mm。使用的钛线提供了线的高生物惰性和可塑性，能够避免组织损伤。
钛线按凹凸表面制成。
能够在钛线表面实现凹凸的技术工艺是：功率超声处理、化学蚀刻、电化学抛光、离子处理，等。这些处理方法将钛线直径减小了初始直径的10-35％，同时减小了交叉环(inter loop)接触面积。结果是，获得了“伸缩效应”：环和线穿过环之间进入临近环的区域，显示于图3a。在未处理的线上没有观察到该效应(图3a)。在图3a和图3a中，箭头和直线表示了在一个环系列中环和线穿过环之间在环内相互穿透；图3a中的相互穿透更强。
伸缩效应和交叉环接触区域中阻力的减小是消除“弹簧”特性的主要原因。通过测量材料的机械性能证实了该事实。
因此，当拉伸编织的网状物时，有零刚性(zero rigidity)Z时期，其中Z aten是具有凹凸线的网状织物(张力编织金属织物)的零刚性，Z nat是具有无凹凸线的网状织(天然编织金属织物)的零刚性，即网状织物无阻力拉伸时图上的面积(图4)。将相同编织类型和线厚度的常规网状织物和处理的网状织物进行比较时，可以确定的是，凹凸线制成的处理的网状织物的零刚度区域比无凹凸的线制成的未处理的网状织物的区域大了20％或更多。
作为工艺流程的结果，凹凸出现在钛线表面：位置无规律的凹下和碰撞(图5a和5b)。
此外，对位于编织的网状织物结构中的线表面进行处理的过程中(例如，采用了电化学抛光)，拉拔线产生的纵向尖锐缺陷(图6a)得以平滑。加工之后缺陷平滑显示于图6b。平滑的纵向缺陷(这是内应力的集中区域)补偿了线本身的残余应力并且减小了网状织物破损的风险。
处理的结果还是钛线直径不均匀，长度从0.00025mm开始波动，这也提供了交叉环空隙的额外自由度。
为了进一步提高可塑性，厚度1至3μm、滑动摩擦系数低并且使环相对于彼此容易地滑动(这对材料的延展性有积极作用)的氧化膜可应用于凹凸钛线的表面。表面氧化膜减小了编织的环之间的摩擦和伴随的负面属性：当拉直材料时破损，等。通过将凹凸线制成的网状织物浸泡于充满了必要溶液的电镀槽中(电流恒定)一定时间来获得氧化膜。取决于时间和选择的电压，钛线表面得到厚度1-3μm的氧化膜。在这种情况下，线本身的厚度并不增加。
植入物1具有5-15cm宽及相同长度的椭圆形(图1)。
生物可吸收聚合物选自聚乳酸。通过将它们固定于网状环结构的下侧来将它们用作下(固定)层3(图2)。聚合物层可由直径0.2-1mm的滴状物组成。滴状物牢固固定，从三侧覆盖网状物环。滴状物层的总厚度不超过0.2-2mm。整个植入物的厚度范围是0.5-4mm。
可将药物包括在生物可吸收聚合物的结构中：抗生素、抗炎药，等。药物逐步释放，可具有延长的治疗效果，预防炎症和伤口感染的发生。
要求保护的发明能够：
-快速牢固固定植入物；
-保证植入物整个表面均匀固定在外科创伤的组织上；
-显著降低外科手术的持续时间，结果是，减少了麻醉剂量和创口体积，从而降低并发症的发生率；
-实现了暂时储存的药物从生物可吸收材料中逐步释放；
-从长期来看，保证了清除外科创伤处除钛线以外的异物。
网状织物的高度可塑性使弹簧特性最小化，降低了组织和粘膜之间生物力学排斥的可能性，并且能够将材料置于粘膜下而不会有损伤风险。网状植入物在外科伤口表面自由膨胀，易于呈现和保持给定形状，如有必要，可通过拉伸来模拟外科伤口的形状。
高孔隙率提高了生物体液向植入物的渗透率，加速了成纤维细胞和成骨细胞定殖过程，并改善了材料的生物整合。
由钛线制成表面凹凸的网状织物一旦与伤口表面接触，即可会浸透血液和伤口渗液，其展示了对伤口表面显著的附着能力，提供了暂时的自固定，使外科医生不必使用其它固定元件：缝合材料、针、微型螺钉等。对伤口表面的高附着能力使得钛网无张力地置于组织上，在植入物下方或覆盖植入物，防止如外科伤口裂开的频繁并发症。
同时，高孔隙度结构不会保留伤口渗液，排除了液体渗漏与随后感染的可能。
线表面的凹凸显著改善了其上纤维蛋白纤维的固定，从而有利于吸引成纤维细胞作为新形成的结缔组织的来源。
实施例1
通过开放手术在三个实验室动物(兔，4个月大)得到前腹壁外侧上腹疝的模型，并且安装了直径60μm的三根单丝线和0.2mm厚自固定层组成的3×3cm自固定网状植入物。腹膜后放置植入物，不使用缝合材料进行固定。在安装过程中，注意到了材料对外科创伤底部的高度附着性和即刻固定性。使用间断的缝线缝合皮肤。术后伤口按预期愈合。3个月后，动物退出实验。当研究形态学变化时：在网状植入物的整个表面发现了白色疤痕，没有检测到聚乳酸的痕迹。当进行显微镜检测时，有序的结缔组织纤维代表术后疤痕结构，没有无菌性炎症的迹象。
实施例2
在腹膜内戊巴比妥钠30mg/kg全身麻醉下，对鼠进行植入要求保护的植入物的干预。进行干预时，动物是6个月大。
通过解剖皮肤、肌肉和皮下脂肪组织直至腹膜来在实验动物的前腹壁上形成外科伤口。植入自固定植入物。缝合皮肤。使用葡萄球菌培养物109CFU/ml感染伤口。将所有动物分成三组，每组6只。
在第一组(对照)，聚丙烯线(外科手术中最常用)制成的网状物用于植入，并用聚丙烯线围绕外周缝合。在第二组，前三只植入了自固定植入物，钛线厚度15μm，钛线表面密度20g/m2，网格尺寸0.1mm，生物可吸收聚合物以直径0.2mm滴状形式，除钛网之外还含有35％(体积/体积)聚乳酸和3％万古霉素；后三只植入自固定植入物，钛线厚度120μm，钛线表面密度80g/m2，网格尺寸2mm，生物可吸收聚合物以直径1mm滴状形式，除钛网之外还含有35％(体积/体积)聚乳酸和3％万古霉素；在第三组中，前三只植入了自固定植入物，钛线厚度70μm，钛线表面密度40g/m2，网格尺寸0.7mm，生物可吸收聚合物以直径0.5mm滴状形式，除钛网之外还含有35％(体积/体积)聚乳酸和5％妥布霉素；后三只植入自固定植入物，钛线厚度100μm，钛线表面密度60g/m2，网格尺寸1.5mm，生物可吸收聚合物以直径0.8mm滴状形式，除钛网之外还含有35％(体积/体积)聚乳酸和5％妥布霉素。观察期持续7天。
在实例中，注意到自固定植入物可快速且容易地安装，这将外科手术持续时间缩短了大约15分钟。注意到，在第二组和第三组的动物中，局部出现炎症。安装之后，观察到，植入物整个表面牢固均匀的固定在手术伤口的组织，没有位移，观察到，植入物植入区域形成了强结缔组织，没有观察到毒性、过敏及其它副反应。在对照组中，观察到，外科伤口组织中的浸润性坏死变化、形成粘连、植入物固定不均匀，使用额外固定架的安装过程耗费了比第二组和第三组动物更多的时间。在研究晚期观察到了最显著的变化。在整个观察期间，研究组和对照组之间的差异都是可靠的。因此，使用要求保护的自固定植入物的效果是显著的。
要求保护的自固定网状植入物提高手术领域中固定的效率，提高可塑性并降低植入物线破损风险；它能够牢固且简单地固定，保证了其整个表面均匀固定在手术伤口的组织上，缩短了手术持续时间，作为结果，减少了麻醉剂量和创口体积，从而降低并发症的发生率。

Claims (10)

1.一种自固定网状植入物，由上层和下层两层组成，基于钛线的网状层在上侧，生物可吸收聚合物层在下侧，其中钛线表面制成凹凸状。
2.根据权利要求1所述的自固定网状植入物，其中所述钛线由5级合金制成。
3.根据权利要求1所述的自固定网状植入物，其中所述钛线的表面凹凸以从0.00025mm开始波动的不均匀钛线直径制成。
4.根据权利要求1所述的自固定网状植入物，其中凹凸钛线的表面涂覆有氧化膜。
5.根据权利要求1所述的自固定网状植入物，其中所述钛线厚度是15-120μm。
6.根据权利要求1所述的自固定网状植入物，其中钛网的表面密度是20-80g/m2。
7.根据权利要求1所述的自固定网状植入物，其中网格尺寸是0.1-2mm。
8.根据权利要求1所述的自固定网状植入物，其中所述下层采用选自聚乳酸的生物可吸收聚合物制成。
9.根据权利要求1所述的自固定网状植入物，其中所述生物可吸收聚合物以直径是0.2-1mm的滴状物形式存在，位于整个下层表面。
10.根据权利要求1所述的自固定网状植入物，其中生物可吸收聚合物的下层含有至少一种药物。
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CN117883214A (zh) 2024-04-16
WO2019151886A1 (ru) 2019-08-08
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