CN114712570A - 宫颈粘连防止装置 - Google Patents
宫颈粘连防止装置 Download PDFInfo
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- CN114712570A CN114712570A CN202011596747.XA CN202011596747A CN114712570A CN 114712570 A CN114712570 A CN 114712570A CN 202011596747 A CN202011596747 A CN 202011596747A CN 114712570 A CN114712570 A CN 114712570A
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Abstract
本发明涉及宫颈粘连防止装置,技术要旨在于,所述宫颈粘连防止装置包括:中空状排液管,插入于子宫颈管;支撑帽,连接于所述中空状排液管的一侧并搭挂在宫颈;固定支柱(Leg),连接于所述中空状排液管的另一侧,通过在子宫内展开来固定所述中空状排液管的位置。所述宫颈粘连防止装置的特征在于,所述排液管相对于所述子宫颈管的插入方向弯曲规定角度而形成。由此,本发明中插入于子宫颈管的排液管弯曲形成,从而具有可以根据患者身体的结构或尺寸进行定制以应用,进而能够稳定地固定于患处,以使能够重建为原来形状,促使恢复迅速的优点。
Description
技术领域
本发明涉及宫颈粘连防止装置,详细而言,涉及一种使插入于子宫颈管的排液管弯曲形成而能够根据患者身体的结构或尺寸进行定制以应用,从而能够稳定地固定于患处促使恢复迅速的宫颈粘连防止装置。
支持本发明的国家研究开发项目如下:
背景技术
女性生殖器官大致由卵巢、子宫及阴道构成,其中患病几率最高的部位是子宫。特别是,将子宫与阴道之间的通道整体称为子宫颈管,在相当于子宫与阴道之间的通路的部分中将从外部可见的部位常称为宫颈。宫颈被认为是子宫细部结构中患病几率最高的部位。
宫颈易患各种疾病,如性接触引起的直接病毒感染、损伤及多种刺激引起的宫颈异型增生、原位癌、浸润性宫颈癌等。
如果通过目视及组织活检发现宫颈疾病,则对宫颈实施圆锥状切除的的宫颈锥形切除术,从而能够利用显微镜放大观察在该部分发生的组织学变化,做出准确的诊断。
宫颈锥形切除术后,通常需要4~6周的恢复期,在诸如宫颈锥形切除术的宫颈手术后,会发生持续性出血或炎症,导致损伤的宫颈恢复迟缓,过度的炎症会诱发受损组织的不规律再生和再生组织的伤痕滋长及过度的组织再生。
另外,宫颈治愈后会发生宫颈内口狭窄及堵塞,引起不孕,且经血无法顺利排出,经血积于子宫,成为引起周期性腹痛及痛经的原因。
如上所述,如果发生诸如宫颈粘连、堵塞等术后并发症,则需利用尖锐器具实施疏通宫颈内口或加宽直径的手术。
即使实施这种疏通及加宽手术,由于宫颈粘连及堵塞是最初损伤的组织在再生过程中形成的,因而暂时的疏通无法成为根本的解决方法,即使在这种疏通及加宽手术后,也会持续发生狭窄及堵塞症状。
因此,需要频繁追加手术,这种追加手术给患者造成许多痛苦,特别是宫颈组织诱发比人体其他部位更高强度的疼痛,因此不仅给患者带来手术上的痛苦,还给患者带来不小的经济负担等诸多问题。
以往在宫颈锥形切除术后也只是等待自然恢复或为了手术部位的收尾及治疗而执行止血、消毒等。
作为对此的解决方法,在韩国授权专利公报第10-1435661号中介绍了一种宫颈术后恢复器具,由颈管软管和后帽构成,所述颈管软管插入于子宫颈管,所述后帽与所述颈管软管一体形成或连接,用于隔绝患处,以促使新皮肤生长为与原来颈部相同的形状。
在韩国授权专利公报第10-1851737号中介绍了一种宫颈粘连防止装置,包括:中空状排液管,插入于子宫颈管;支撑帽,连接于所述中空状排液管的一端部,并搭挂在子宫入口;至少一个固定支柱(Leg),连接于所述中空状排液管的另一端部,通过在子宫内展开来固定所述中空状排液管位置。
所述现有技术提供一种能够在宫颈手术后防止子宫粘连且手术简便容易并可将位置固定在子宫而稳定加装的宫颈粘连防止装置。
但是,就所述现有技术而言,由于整体形状是固定的,不符合患者个人的身体结构及尺寸需求,所以无法重建或恢复为手术前的状态,或装置会随着身体活动而发生移动,因此作为用于术后治疗及恢复的器具存在不足之处。
发明内容
本发明为解决上述问题,其目的在于提供一种使插入于子宫颈管的排液管弯曲形成而能够稳定地固定于患处,从而促使恢复迅速的宫颈粘连防止装置。
为了达成所述目的,本发明的技术要旨在于,所述宫颈粘连防止装置包括:中空状排液管,插入于子宫颈管;支撑帽,连接于所述中空状排液管的一侧并搭挂在宫颈;固定支柱(Leg),连接于所述中空状排液管的另一侧,通过在子宫内展开来固定所述中空状排液管的位置。所述宫颈粘连防止装置的特征在于,所述排液管相对于所述子宫颈管的插入方向弯曲规定角度而形成。
另外,优选地,所述排液管形成为能够通过角度调节装置调节及固定所述角度。
另外,优选地,所述角度调节装置以设置在所述排液管内部的金属丝的形式体现。
另外,优选地,所述金属丝沿所述排液管的长度方向以直线状形成或沿着所述排液管的圆周以圆筒状或螺旋状形成。
另外,优选地,所述角度调节装置以所述排液管外周面呈皱褶部的方式体现。
另外,优选地,所述固定支柱形成有两个以上且能够在子宫内展开,优选地,所述固定支柱展开到最大时的所述固定支柱间的角度与宫颈的角度相比形成得大。
另外,优选地,所述固定支柱展开到最大时的角度与所述宫颈的角度的差为5°~10°以内。
另外,优选地,在所述支撑帽的上层层叠有敷料,或在所述支撑帽的表面涂覆有敷料。
本发明中,插入于子宫颈管的排液管弯曲形成,或能够调节并固定排液管的角度,从而具有可以根据患者身体的结构或尺寸进行定制以应用,进而能够稳定地固定于患处,以使能够重建为原来形状,促使恢复迅速的效果。
另外,固定支柱的角度相比宫颈的解剖学角度形成得大,所以能够根据患者的宫颈结构及尺寸展开,从而能够更稳定地固定于患处,促使恢复更迅速。
附图简要说明
图1是本发明一实施例的宫颈粘连防止装置的模式图。
图2是图1的沿D-D’截开的剖面图。
图3至图5是本发明多个实施例的宫颈粘连防止装置的模式图。
具体实施方式
在本发明的宫颈粘连防止装置中,插入于子宫颈管的排液管弯曲形成,或能够调节并固定排液管的角度,从而可以根据患者身体的结构或尺寸进行定制以应用,进而能够稳定地固定于患处,以使能够重建为原来形状,促使恢复迅速。
另外,固定支柱的角度相比宫颈的解剖学角度形成得大,所以能够根据患者的宫颈结构及尺寸展开,从而能够更稳定地固定于患处,促使恢复更迅速。
下面参照附图,对本发明进行详细说明。图1是本发明一实施例的宫颈粘连防止装置的模式图,图2是图1的沿D-D'截开的剖面图,图3至图5是关于本发明多个实施例的宫颈粘连防止装置的模式图。
如图所示,本发明的宫颈粘连防止装置包括:中空状排液管100,插入于子宫颈管;支撑帽200,连接于所述中空状排液管100的一侧并搭挂在宫颈;固定支柱(Leg)300,连接于所述中空状排液管100的另一侧,通过在子宫内展开来固定所述中空状排液管100的位置。所述宫颈粘连防止装置的特征在于,所述排液管100形成为相对于所述子宫颈管的插入方向弯曲规定角度。
由于本发明的宫颈粘连防止装置是在插入于体内的状态下在恢复期期间内一直佩戴,因而优选由对人体无害的材质制成,可以使用含硅胶、聚乙烯或它们中的一种以上的复合材料等。
例如,可以以多种方式实施,例如,所述中空状排液管100、支撑帽200及固定支柱300由硅胶材质一体成型;或者中空状排液管100由硅胶材质制成,支撑帽200由缝合丝材质制成,并彼此连接;或者中空状排液管100与支撑帽200均由缝合丝材质制成等。
就所述缝合丝材质而言,用于普通治疗手术过程中的切开部位的缝合,在患处治疗后去除缝合丝,或使用可吸收(Absorbable)材料,例如使用聚乳酸(Polylactic Acid)或聚二恶烷酮(Polydioxanone)、乳酸(Lactic Acid)与乙醇酸(Glycolic Acid)的共聚物等,手术后即使不将其去除,也能在体内吸收。
如图所示,所述中空状排液管100作为插入于子宫颈管的构件可呈内部形成有空间的具有通道的中空形状,所述通道能够使从子宫生成的分泌物向外部排出。另外,所述中空状排液管100可以在侧部具有一个以上用于排出所述分泌物的排液口110。
所述排液管100以规定长度形成,以便从宫颈插入于子宫颈管,使固定支柱300可以展开并搭挂在子宫内。
本发明的排液管100的特征在于,相对于所述子宫颈管的插入方向弯曲规定角度形成。这可以通过排液管成型时或宫颈粘连防止装置成型时,先将制品加热后再利用夹具弯曲规定角度来形成,或是将材料插入于具有与排液管弯曲角度对应形状的模具后通过注塑成型等方法,来提供具有弯曲形状的排液管。
本发明的排液管100与人体解剖学形状对应地弯曲规定角度而形成,特别是优选相对于所述子宫颈管的插入方向具有3~30°左右的角度A。
这种排液管100以在制造时就被弯曲成规定角度的状态提供,或者根据需要也可以形成为能够通过角度调节装置来实现角度调节及对已调节角度的固定。
所述角度调节装置作为能够使所述排液管100弯曲使用者所希望的角度的装置,可由柔软的材料制成且具有规定硬度,以便保持弯曲的状态。
为此,如图1所示,本发明一实施例的角度调节装置以设置在所述排液管100内部的金属丝120的形式体现。
所述金属丝120以在所述排液管100成型时通过嵌件注塑成型以被包裹在构成所述排液管100的材质的内部的方式形成。所述金属丝120可以由对人体无害的材质,例如不锈钢金属丝或Ti金属丝、Ti合金金属丝制成,或以具有双重硬度的方式形成,也就是将具有比构成所述排液管100外皮的树脂材料更高硬度的树脂材料作为内部的芯。
如图1及图2所示,根据本发明一实施例,在所述排液管100内部具有金属丝120,金属丝120能够根据患者的患处进行弯曲且具有特定硬度,所述特定硬度能够使规定角度A得以保持的同时被固定。
其中,所述金属丝120也可以延伸至后述支撑帽200,可以形成得能够对支撑帽200的角度进行调节及固定。
本发明中的金属丝120设置在所述排液管100内部,且可以沿所述排液管100的长度方向以直线状形成,或者也可以以沿着所述排液管100的圆周设置在排液管100内部的方式以圆筒状形成。另外,也可以以沿着排液管的圆周设置在排液管内部的方式以螺旋状形成。
这种本发明一实施例的角度调节装置赋予排液管100具有规定硬度,使得在能够更稳定地保持角度的同时,即使身体移动,折叠或凹陷的部分也达到最小,使得宫颈内口的形状能够被恒定保持,从而在没有伤痕的情况下,使组织再生既规律又整洁。
另外,作为本发明另一实施例,如图3所示,其特征在于,为了调节及固定所述排液管100的角度,所述排液管100外周面以皱褶部130的形式体现。所述皱褶部130可以形成在整个所述排液管100上,也可以形成在特定位置上。
根据需要,在形成有所述皱褶部的排液管内部还可以包括上述金属丝。
通过所述皱褶部130能够容易调节所述排液管100的角度,并能够固定该角度。所述皱褶部130的特征在于,皱褶高度为0.5~1.5mm,皱褶间距为0.1~1.0mm左右,以便组织再生时不对皱褶形状造成影响,并且皱褶部130的皱褶以规定间距细密形成,使得所述排液管100具有规定硬度,从而能够实现排液管100的弯曲及其角度的保持。
由此,使得医疗人员可以根据患者个人的宫颈及子宫颈管或子宫内部的形状,调节所述排液管100的角度,从而可以防止本发明的宫颈粘连防止装置脱离及移动,并且根据患者的身体结构稳定地固定于患处,从而能够重建为原来形状,促使恢复迅速。
而且,所述支撑帽200可以连接于所述中空状排液管100的一端部并搭挂在宫颈。此时,优选以所述中空状排液管100为中心轴进行连接。即,所述支撑帽200的中央部与所述中空状排液管100的一侧连接。
所述支撑帽200在表面具备至少一个以上的排液口210,可使患处恢复时发生的诸如炎症物质的异物质顺利排出到外部而帮助恢复。
就所述支撑帽200的排液口210而言,在所述支撑帽200为硅胶材质的情况下,在成型过程中一体形成一个或多个排液口210,在所述支撑帽200由缝合丝材质构成的情况下,可以以网状构成(编织)所述支撑帽200,从而自然地形成一个或多个排液口210。
所述支撑帽200呈以所述中空状排液管100为中心轴向四周扩展规定长度的形状,可以为圆形、多边形、星形或辐射状,以彼此分离的形状构成,但并非限定于此,只要是能够搭挂在宫颈的形状即可。
另外,所述支撑帽200可以是整体剖面为平缓的山形状或四边形状、椭圆形状等,只要是与患者原来子宫接近的形状,任何形状都可以,因此不限制其形状为某一形状。优选地,所述支撑帽200以越远离所述中空状排液管100则厚度越小的方式倾斜,以圆形形状形成,以便顺利地进行排液。
所述支撑帽200可以在上部面(宫颈接触面)形成有凸起或凹凸,以防止紧贴于宫颈。
另外,如上所述,在支撑帽200内部也可以包括像所述金属丝120一样高硬度的材质,以便容易调节及固定所述支撑帽200的角度。由此,能够根据子宫颈管及宫颈的斜率,调节所述排液管100与所述支撑帽200所构成的角度,使得可以根据患处的结构及尺寸来进行调节和使用。
而且,所述固定支柱300连接于所述中空状排液管100的另一端部,并能够在子宫内展开,用于固定所述中空状排液管100的位置,而且可以设置有一个以上。因此,优选所述固定支柱300采用柔软材料。
所述固定支柱300从所述中空状排液管100向多个方向长长地延伸形成,在中间部包括分别向左右方向延伸形成的翼部,从而确保可固定在子宫内的面积变得更宽广。
另外,在固定支柱300的末端部形成有固定用凸起310,使得在子宫内实现良好的固定。
其中,在所述中空状排液管100的一端部外径与所述支撑帽200连接的位置形成有插入孔,使得导管(图上未示出)可以沿着所述中空状排液管100的外径部插入,从而使所述固定支柱300能够展开(去除导管时),或在导管内容纳有所述固定支柱300及排液管100的状态下使导管通过子宫颈管插入。
即,将本发明的宫颈粘连防止装置加装于患处时,在所述导管内部容纳有所述中空状排液管100及固定支柱300的状态下,将导管插入于宫颈与子宫颈管内部,之后去除所述导管,从而使所述固定支柱300在子宫内展开,固定所述中空状排液管100的位置。
此时,所述固定支柱300形成有两个以上且能够在子宫内展开,从而稳定地固定于子宫内壁(宫颈侧)。
另外,所述固定支柱300如图4所示,所述固定支柱300展开到最大时的角度与宫颈的角度,即,子宫内壁侧的宫颈侧角度相比形成得大,所以能够根据患者的宫颈结构或尺寸而张开,从而能够使本发明的宫颈粘连防止装置发生移动或脱离的情况达到最少,进而促使恢复迅速。
此时,在所述固定支柱300形成在以所述中空状排液管100为中心的两侧即构成一对的情况下,优选地,当所述固定支柱300展开到最大时,所述固定支柱300间的角度B呈180~250°。
即,所述固定支柱300的角度以大于宫颈的解剖学角度的方式形成,使得固定支柱300能够根据患者宫颈的结构及尺寸适合地展开,从而在宫颈及子宫颈管手术时,能够稳定地固定于子宫内壁(宫颈侧),进而防止宫颈粘连防止装置移动或脱离。
另外,优选地,所述固定支柱300展开到最大时的角度与所述宫颈的角度的差在5°~10°以内。如果角度差过小,则稳定地固定于子宫内壁侧的力过弱,如果角度差过大,则过度按压子宫内壁侧,因而上述范围最适合。
另一方面,如图5所示,在所述支撑帽200的上层可层叠有敷料400,或在所述支撑帽200表面涂覆形成有敷料400。所述支撑帽200以能够搭挂在宫颈的方式构成,所述敷料400形成在宫颈表面与所述支撑帽200之间,起到吸收术后从患处渗出的血液或渗出物或者辅助患处组织快速再生的作用。
因此,所述敷料400基本上由生物相容性卓越的材料形成,可以包含发挥止血作用并具有防止宫颈组织粘连、促进组织再生功能的功能性成分。
为了止血,所述敷料400可以只由基于纤维的无纺布构成,为了利用壳聚糖的有效功能,也可以只由基于壳聚糖的无纺布构成。此时,只应用壳聚糖时,在凝胶化的同时材料变软,会难以维持强度及形状,因而可以在壳聚糖中混合纤维素(棉、绢或麻)、再生纤维素(人造纤维或人造丝)、海藻酸及酪蛋白而制作。
另外,所述敷料400可以混合止血材料而以无纺布形式提供,或以在表面形成有由止血材料制成的单层或多层涂层的无纺布形式提供。
另外,所述敷料400可以由天然生物相容性材料或合成生物相容性材料制成,可以单独使用所述材料,或为了支撑所述材料而可以混合使用上述纤维素(棉、绢或麻)、再生纤维素(人造纤维或人造丝)、海藻酸及酪蛋白等。
本发明的敷料400形成在所述支撑帽200上,其特征在于,由与所述中空状排液管100底部结合的结合孔和以上面侧朝向所述宫颈的方式形成的本体构成。
即,所述敷料400以将所述中空状排液管100置于中心部的方式结合在所述支撑帽200上,因此需在中心部形成有用于与所述中空状排液管100结合的结合孔。所述结合孔只要以能够容纳所述中空状排液管100程度的大小形成即可,其形状对应于所述支撑帽200的形状,可以形成为圆形或多边形。
另外,所述敷料400的本体形成为以所述结合孔为中心的圆形或多边形,所述敷料400位于所述支撑帽200上且面向宫颈,而且以具有与所述支撑帽200相似的大小和形状的方式形成。所述敷料400的形状根据患处的应用环境来变形而形成。
其中,特征在于,所述敷料400在吸收血液或渗出物后,竖直剖面呈三角形或上侧宽度比下侧宽度窄的多边形形状。这是为了使诸如宫颈这样形状的患处能够被更好地实施止血管理等。
即,本发明的敷料400以吸收后的形状为基准,通过成型模具制得,且被冷冻干燥后提供。压缩所提供的敷料400的上部,制造成吸收前的形状,如果吸收血液或渗出物而发生膨胀,则变为吸收后的形状。即,变回压缩前的已冷冻干燥的初始形状。
如上所述,所述敷料400既可以被冷冻干燥压缩后以物理方式结合于所述中空状排液管100而层叠于所述支撑帽200的上层,也可以涂覆形成在所述支撑帽200表面。即,可以将所述支撑帽200含浸于含有敷料400的溶液中,或以静电纺丝等方法在宫颈粘连防止装置上形成所述敷料400。
作为本发明一实施例,在宫颈粘连防止装置中包含敷料,以使在宫颈手术即锥形切除术后容易管理患处的出血及渗出物,而且还也可以添加功能性成分,进一步具有快速止血管理、防止粘连、组织再生等功能。
如上所述,本发明的宫颈粘连防止装置能够调节并固定插入于子宫颈管的排液管的角度,从而可以根据患者身体的结构或尺寸进行定制以应用,进而能够稳定地固定于患处,以使能够重建为原来形状,促进恢复迅速。
另外,固定支柱的角度相比宫颈的解剖学角度形成得大,所以能够根据患者的宫颈结构及尺寸而展开,从而能够更稳定地固定于患处,促使恢复更迅速。
Claims (11)
1.一种宫颈粘连防止装置,包括:
中空状排液管,插入于子宫颈管,
支撑帽,连接于所述中空状排液管的一侧并搭挂在宫颈,
固定支柱,连接于所述中空状排液管的另一侧,通过在子宫内展开来固定所述中空状排液管的位置;
所述宫颈粘连防止装置的特征在于,
所述排液管相对于所述子宫颈管的插入方向弯曲规定角度而形成。
2.根据权利要求1所述的宫颈粘连防止装置,其特征在于,
所述排液管形成为能够通过角度调节装置调节及固定所述角度。
3.根据权利要求1所述的宫颈粘连防止装置,其特征在于,
所述角度调节装置以设置在所述排液管内部的金属丝的形式体现。
4.根据权利要求3所述的宫颈粘连防止装置,其特征在于,
所述金属丝沿所述排液管的长度方向以直线状形成。
5.根据权利要求3所述的宫颈粘连防止装置,其特征在于,
所述金属丝沿着所述排液管的圆周以圆筒状形成。
6.根据权利要求3所述的宫颈粘连防止装置,其特征在于,
所述金属丝沿着所述排液管的圆周以螺旋状形成。
7.根据权利要求1所述的宫颈粘连防止装置,其特征在于,
所述角度调节装置以所述排液管外周面呈皱褶部的方式体现。
8.根据权利要求1所述的宫颈粘连防止装置,其特征在于,
所述固定支柱形成有两个以上且能够在子宫内展开。
9.根据权利要求8所述的宫颈粘连防止装置,其特征在于,
所述固定支柱展开到最大时的所述固定支柱间的角度与宫颈的角度相比形成得大。
10.根据权利要求9所述的宫颈粘连防止装置,其特征在于,
所述固定支柱展开到最大时的角度与所述宫颈的角度的差为5°~10°以内。
11.根据权利要求1所述的宫颈粘连防止装置,其特征在于
在所述支撑帽的上层层叠有敷料,或在所述支撑帽的表面涂覆有敷料。
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