CN112040995B - 外科整形软组织用无张力钛金属经编织物 - Google Patents
外科整形软组织用无张力钛金属经编织物 Download PDFInfo
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Abstract
本发明涉及医学和医疗技术领域,并且旨在改善用于精细外科整形的薄解剖结构:眼睑、角膜等的网状植入物的技术性能。一种用于外科整形软组织的无张力钛金属经编织物是由被弯曲以形成互连的线圈的钛线制成的网状织物,其中所述钛线具有波状外形的表面。技术效果是材料的弹性降低和可塑性增加,使得可以将所述材料结合到薄解剖结构中而没有损伤的风险,同时改善结缔组织的形成,减少创口分泌物,缩短愈合时间,并降低并发症的发生率,从而使患者能够更快康复。
Description
技术领域
本发明涉及医学和医疗技术领域,旨在改善用于精细外科整形的薄解剖结构:眼睑、面部组织、腹股沟管腹环等的网状内假体的技术性能。
背景技术
从现有技术(RU 160627 U1,2016年3月27日公开)中已知这样一种方案,其记载了一种用于疝修补术的网状材料。用间断的U形缝合线或连续缝合线将带有生物活性涂层的钛丝网沿周边固定在边缘。如果需要将该网状物非常可靠地固定到组织上,可以沿着疝孔的边缘使用第二个周边缝合线。
这种方案(也即上述方案)的缺点是当固定网状内假体时,以各种方式制成的缝合线或钉书钉的形式使用额外的固定器。该方案不能快速建立内假体的牢固固定,并且不能确保内假体的整个表面均匀地固定在手术创口的组织上,同时这些线不具有高可塑性并且具有高断裂风险。
由现有技术(RU 121735 U1,2012年11月10日公开)已知这样一种方案,其记载了用于外科整形的钛金属经编织物。该金属经编织物用钛含量为至少80%的钛合金线制成,呈网状物形式,同时该网状物包含被弯曲以形成互连线圈的线。使用间断的U形缝合线或连续缝合线在边缘沿周边固定该网状物。如果需要将该网状物非常可靠地固定在组织上,则可以沿着疝口的边缘使用第二个周边缝合线。也可以用钛订书钉固定该网状物。
天然金属经编织物(尚未通过其他影响线粗的方法进行处理)的缺点是有弹簧性能(弹性),当材料变形以形成线圈时不可避免地会发生这种现象,其密度通常比纬编(filling-knit)材料更高。由于线圈的相互张力,网状物可以变形、扭曲、形成褶皱并对相邻的结构施加压力,导致其所缝合的身体组织拉伸。作为弹性的结果,可能出现在组织中形成溃疡、穿过精细结构的材料裂开 (cheese-wiring)、从缝合材料上撕裂网状物、使植入物起皱、使材料边缘卷曲以及在手术创口中难以扩张。同时,当将其放置在薄解剖结构(例如眼睑的粘膜下层、角膜等)中时,弹簧性能不允许使用该材料,这是由于可能会造成材料裂开或用钛网的单个线在粘膜上打孔的风险。目前现有的材料不能将天然金属经编织物快速适当地放置在具有粘膜且临近组织厚度小于1mm的薄解剖结构中,也不能将其整个表面均匀地固定到手术创口的组织上。
要求保护的发明使得能够基本上克服所指出的原型中固有的缺点。
发明内容
所提出的技术方案解决的技术问题是开发具有高可塑性和低弹性的金属经编织物,其可降低对薄解剖结构的损伤风险,并且能够将金属经编织物用于那些迄今为止还没有使用由金属经编织物制成植入物的领域(例如眼睑粘膜下层、角膜等的整形)。
技术效果是降低金属经编织物的弹性并提高其可塑性,从而可将所述织物合并到薄解剖结构中而没有损伤的风险,同时改善结缔组织的形成,减少创口分泌物,缩短愈合时间,并降低并发症的发生率,从而使得患者能够更快地康复,因此扩大了金属经编织物在那些钛的生物惰性和材料的高可塑性特别重要的领域中的应用范围。
由于用于外科手术整形软组织的无张力的钛金属经编织物是由被弯曲以形成互连的线圈的钛线制成的网状织物,其中钛线具有波状外形的表面 (contoured surface),因此实现了所述技术效果。
网状织物基于纬编编织或经编编织制成。
钛线的波状外形的表面使钛线具有变化的直径,所述直径的波动范围为0.0025mm。
在波状外形的钛线的表面涂上氧化膜。
氧化膜的厚度为1-3μm。
钛线由GRADE-5合金制成。
附图说明
图1a为具有波状外形的线的无张力金属经编织物中内线圈区域的状态。
图1b为具有非波状外形的线的天然金属经编织物中的内线圈区域的状态。
图2为拉伸针织网状物的零刚度图。
图3a为化学蚀刻后的线表面浮雕的示例。
图3b为离子处理后的线表面浮雕的示例。
图4a为处理前带有纵向尖锐缺陷的线横截面。
图4b为处理后带有平滑的纵向缺陷的线横截面。
具体实施方式
无张力金属经编织物为由被弯曲以形成互连线圈的钛线制成的网状织物,该织物用作内假体,旨在例如用于精细整形线上方具有层厚度小于1mm的软组织(上下眼睑、壁腹膜等)。无张力金属经编织物可制成进行植入其的操作所需的任何形状或尺寸。
网状织物由纬编(线直径为100-140μm)网状物或经编(线直径为20-70 μm)网状物表示。线可由VT1-00、VT-1.00wa(GRADE-1)或VT6(GRADE-5) 钛合金制成。所用钛线具有高生物惰性和线可塑性,且可避免损坏组织。所述钛线具有波状外形的表面。
能够获得具有钛线的波状外形的表面的无张力金属经编织物的工艺流程是:功率超声处理、化学蚀刻、电化学抛光、离子处理等。这些处理方法将已经存在于针织网状织物结构中的钛线的直径减小了初始直径的10-35%,同时减小了内线圈接触的面积,从而降低了金属经编织物的弹性并显著增加了塑性,形成了对创口表面具有高粘附力的多孔结构。结果,实现了“伸缩效应(telescopic effect)”:线圈和内线圈穿插浮动到相邻线圈的区域,如图1a所示。在未经处理的(天然的)金属经编织物(图1b)中未观察到该效应。在图1a和1b中,箭头和直线表示线圈和内线圈的穿插浮动到同一横列(wale)的线圈内,其中图1a中的穿插更多。
内线圈接触区域的伸缩效应和阻力降低是消除金属经编织物“弹簧”性能的主要因素。这一事实通过测量材料的机械性能得到了证实。
因此,当拉伸编织网时,存在零刚度Z的周期(图2),该周期在图上显示为网状织物被无阻力拉伸的区域,其中Z aten是具有波状外形的线(contoured thread)的无张力金属经编织物的零刚度,而Z nat是具有非波状外形的线的天然金属经编织物的零刚度。当比较具有同种针织类型和线粗的天然金属经编织物和无张力金属经编织物时,无张力金属经编织物的零刚度区域比天然材料的零刚度区域至少大20%。
作为工艺操作的结果,形成了钛线的波状外形的表面:无序分布的凹陷和凸起(图3a和3b)。
此外,在处理过程中,例如通过电化学抛光,在位于无张力网状织物的结构中的线的表面,使由线的拉伸引起的纵向尖锐的缺陷(图4a)变得平滑。处理后缺陷变平滑的情形如图4b所示。作为内部应力集中点的纵向缺陷被消除,因此额外的处理协调了线本身的残余应力,并降低了网状织物断裂的风险。
该处理也使钛线具有变化的直径,且沿钛线长度方向的波动范围为 0.00025mm,这也为线在内线圈间隙的移动提供了额外的自由。
为了进一步提高可塑性,可在无张力金属经编织物的表面施加1-3μm厚的氧化膜。众所周知,应用氧化钛使滑动摩擦系数降低了约3倍,并显著提高了无张力经编织物的响应性,以使线圈相对于彼此容易滑动,这积极地影响了材料的延展性。表面氧化膜减小了针织线圈之间的摩擦,还减少了伴随的负面性能:材料拉直时断裂等。
氧化膜通过将由波状外形的线制成的网状织物浸入充满所需溶液的电镀浴中,在恒定电流下持续一定时间而获得。取决于时间和所选电压,在钛线表面形成1-3μm厚的氧化膜。在这种情况下,线自身的粗度不会增加。
无张力金属经编织物的高可塑性使得弹簧性能最小化,降低了组织和粘膜之间的生物力学不相容的可能性,并能够将材料放置在粘膜下,而没有损伤的风险。由无张力金属经编织物获得的网状植入物在手术创口的表面上自由膨胀,易于呈现并保持给定的形状,并且如果需要,可以根据手术创口的形状通过拉伸进行建模。
高孔隙率还增加了生物流体进入植入物内部的渗透速度,加速了成纤维细胞和成骨细胞在植入物中的定植过程,并改善了材料的生物整合性。
与创口表面接触的无张力金属经编织物会立即被血液和创口分泌物浸渍,并表现出对创口表面的明显粘附力,以提供暂时的自固定效果并允许外科医生避免使用固定元件:缝合材料、引脚(pins)、微螺钉等。无张力金属经编织物对创口表面的高粘附力允许放置钛网,而不会在植入物下面或覆盖植入物上的组织上产生张力,从而避免了诸如手术创口开裂这样的常见并发症。
同时,高度多孔的结构不存留创口分泌物,消除了液体泄漏和随后感染的可能性。
线的波状外形的表面显著改善了纤维蛋白纤维在其上的固定,从而促进吸引成纤细胞作为新形成的结缔组织的来源。
要求保护的技术方案的主要优点是:
-在钛线上获得表面浮雕;
-通过减小成品网状纤维结构中的钛线的直径,减小了内线圈接触的面积,并因此出现了伸缩效应;
-获得直径变化的钛线,波动范围为0.0025mm;
-弹性降低,可塑性提高,形成对创口表面具有高粘附力的多孔结构;
-材料的零刚度指数增加。
该指标通过在张力大于16N/cm的情况下,从初始状态到出现弹性性能的网长度增加的百分比来衡量。同时,无张力金属经编织物具有零刚度指数,其比天然金属经编织物高20%以上(图2)。
实施例1
获取线直径为30μm、尺寸为3× 3mm的无张力金属经编织物制成的用于角膜移植术的内假体,用于三只实验动物(兔子,4月龄),并且使用标准外科技术植入。在植入手术中,注意到了材料的高可塑性,这使得易于将所述材料放置在角膜组织中。同时,模拟了上眼睑破裂伴结缔组织缺损,用相同的金属经编织物填充。主要目的是术后创口愈合。10天后,将这些动物从实验中撤出。当研究形态学变化时,在网状织物的整个表面上发现了白色疤痕;显微镜检查后,术后疤痕的结构表现为有序的结缔组织纤维,没有无菌性炎症的迹象。
实施例2
在腹腔注射30mg/kg戊巴比妥钠(Nembutal)而全身麻醉的大鼠内,手术干预植入所述要求保护的无张力钛金属经编织物。干预时,动物为6月龄。
通过将皮肤、肌肉和皮下脂肪组织解剖到腹膜,在实验动物的前腹壁上形成手术创口。将无张力钛金属经编织物后腹膜植入金属经编织物和腹膜之间的边界部位,其厚度不超过0.5mm。应用肌肉缝合线、皮下脂肪缝合线和皮肤缝合线。将所有动物分成两组,每组6只。
在第一组(对照组)中,使用具有非波状外形的线的天然金属经编织物制成的网状物进行植入。在第二组中,向个体植入具有波状外形的线的无张力钛金属经编织物,所述波状外形的线具有沿其长度变化的直径。观察15天。然后将实验动物从实验中撤出。
注意到无张力钛金属经编织物的安装快速简便,其将手术时间缩短了约15 min。值得注意的是,在第二组动物中,通过主要目的进行的缺损修复没有特殊的临床特征。在形态学检查期间,确定了无张力钛金属经编织物的整个表面与手术创口的组织的固定牢固均匀,且没有位移;植入物的每一侧都有坚固的结缔组织。未观察到毒性、过敏或其他不良反应。在第一组中,安装过程需要更多的时间,这是由于材料的边缘卷曲和扭曲。形态学检查显示张力区疤痕过多。注意到腹腔内有疤痕粘连。在一个病例中,观察到腹膜被弹性钛线穿孔,并形成由穿孔周围的焊接网膜组成的厚浸润(thick infiltrate)和粘连。动物的恢复时间比主要组中的长30%。在对照组的一个病例中,注意到了材料的位移,因此需要进行修正以将其移除。研究组和对照组之间的差异非常显著。因此,已经注意到使用所要求保护的无张力钛金属经编织物的有效性。
要求保护的无张力钛金属经编织物具有增加的可塑性和低弹性,使断线的风险最小化,其被牢固且容易地固定,使得与手术创口组织的整个表面均匀固定,缩短了手术持续时间,并且因此减少了麻醉和创伤的量,使得并发症发生率降低。
Claims (5)
1.一种用于外科整形软组织的无张力钛金属经编织物,其中所述织物是由被弯曲以形成互连的线圈的钛线制成的网状织物,其中所述钛线具有波状外形的表面,所述波状外形的表面使钛线具有变化的直径,所述钛线包括无序定位的凹陷和凸起,并且所述钛线由GRADE-1合金制成。
2.根据权利要求1所述的无张力钛金属经编织物,其中所述网状织物基于纬编编织或经编编织制成。
3.根据权利要求1所述的无张力钛金属经编织物,其中所述钛线的波状外形的表面使钛线具有变化的直径,其波动范围为0.0025mm。
4.根据权利要求1所述的无张力钛金属经编织物,其中在波状外形的钛线的表面施加氧化膜。
5.根据权利要求4所述的无张力钛金属经编织物,其中所述氧化膜的厚度为1-3μm。
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