CN106994192B - 一种止流型导尿管 - Google Patents

一种止流型导尿管 Download PDF

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CN106994192B
CN106994192B CN201710346461.8A CN201710346461A CN106994192B CN 106994192 B CN106994192 B CN 106994192B CN 201710346461 A CN201710346461 A CN 201710346461A CN 106994192 B CN106994192 B CN 106994192B
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董东生
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Shandong Baixin Medical Products Co ltd
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JW ICU Medical Ltd
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Abstract

导尿为最常见的临床操作，当导尿管头部的尿液入口进入膀胱内，尿液因膀胱内的压力而缓缓从导尿管流出至弯盘等容器内，此时可判断导尿管置入成功，随即将引流尿袋接头插入导尿管尿液出口，成为一封闭系统。临床资料显示这种使尿液流出后再连接引流袋接头的方式存在极大感染风险。本发明提供了一种止流型导尿管，其尾部的将导尿管内腔对外封闭的阻止液体但不阻止气体通过的疏水止流膜片，可以在尿液不流出导尿管且不污染导尿管尿液出口的前提下，有效判断出导尿管是否置入成功，从而最大程度减轻和避免因导尿管与引流袋接头处的污染而导致的感染风险。

Description

一种止流型导尿管
技术领域
本发明涉及导尿管，特别涉及一种止流型导尿管，属医疗器械技术领域。
背景技术
导尿管为临床最为常见的医疗器械，从尿道置入人体后可将尿液从膀胱引流至体外；可一次尿液引流后取出，也可长期留置用于多次引流。
导尿管置入的操作通常是用一手按压尿道外口周边组织使其相对固定，撑开并暴露尿道外口，另一手直接或用镊子、止血钳等把持无菌导尿管，从尿道外口徐徐插入；当导尿管尿液入口进入膀胱内时，尿液因膀胱内的压力而缓缓从导尿管尿液出口流出至弯盘等容器内，此时可判断导尿管置入成功，随即将引流尿袋接头插入导尿管尿液出口，成为一封闭系统，然而这种使尿液流出后再连接引流袋接头的方式存在极大感染风险，文献指出：导尿管与引流袋接头连接处的污染是逆行性尿路感染常见原因，而此处的尿液污染则诱导和加大了这种风险。
现有导尿存在以下问题：
需将尿液引流出导尿管尿液出口，流至弯盘等容器后方才判断导尿管置入成功，随后再连接引流尿袋接头，尿液通常会污染二者的连接处，空气中或周围物体表面的微生物在这部分尿液中繁殖，再次拔插引流尿袋接头时极易引起导尿管腔内污染。
很多情况下将导尿管头部置于膀胱内，建立了引流通道，但并不急于引流尿液，如全身麻醉；有时还有更紧要的病情需处理，不应因必须连接引流袋的操作而耽搁。部分患者因膀胱逼尿肌无力或膀胱顺应性下降等原因还须进行膀胱训练，膀胱训练往往阻止持续开放引流而是使膀胱充盈到一定程度再排尿。
发明内容
本发明为了解决上述不足，提供了一种止流型导尿管。
本发明的目的是这样实现的：
一种止流型导尿管，包括具有内表面、外表面的实体材料构成的中空的主体管路，管路中空为导尿管内腔，包括使用时进入膀胱的头部，留置于体外的尾部及连接头部与尾部的中间部，头部设有尿液入口，尾部设有尿液出口；其特征在于，还包括设于导尿管尾部的将导尿管内腔对外封闭的阻止液体但不阻止气体通过的疏水止流膜片。
疏水止流膜片在额定压力及流量下阻止液体但不阻止气体通过。
患者排尿时的膀胱内压通常在10千帕之内，具体实施中可选用阻水压力10-20千帕左右的孔径0.1-10微米的由PTFE、PVDF、PES、PAN等聚合物制成的疏水止流膜即可。
进一步的，疏水止流膜片外周密封连接有环形的固定壳体构成止流部件，固定壳体与导尿管尾部的导尿管内腔内表面密封连接。
为了更好的固定连接，导尿管尾部的导尿管内腔内表面局部向导尿管壁内环形凹陷适形容纳固定壳体并密封连接。
一种易于实现的方案是用疏水止流膜片将导尿管尾部与导尿管内腔连通的尿液出口封闭，疏水止流膜片外周边缘与导尿管尾部端面连接为一体。
为了便于观察，至少疏水止流膜片附近区域的导尿管壁为透明或目力可及的部分透明。
为了不急于连接引流袋，尿液出口的一段导尿管尾部被易于开启的密封部件封闭，尿液出口位于由易于开启的密封部件密封形成的无菌防护腔体内，可防护空气中及可能接触到的物体对尿液出口的污染。
所述易于开启的密封部件可以是柔性膜片构成的袋状，与导尿管尾部外表面密封连接形成防护腔体，也可以通过一与导尿管尾部外表面密封连接的过渡部件密封连接从而形成上述防护腔体，易于开启的密封部件边缘上可设有开启撕口；易于开启的密封部件还可以由硬质的可开合的两个零件构成，开启之前此两个零件密封连接。
形成防护腔体封闭尿液出口的易于开启的密封部件在使用前与导尿管的其他部分共同处于无菌包装内。
尿液出口的一段导尿管尾部被易于开启的密封部件封闭，封闭尿液出口的易于开启的密封部件本身为气体易于通过的材质。
尿液出口的一段导尿管尾部被易于开启的密封部件封闭，封闭尿液出口的易于开启的密封部件上设有至少一个通气膜片。
疏水止流膜片上加入干化学法尿液分析常用的变色反应物质。如尿常规检测中的pH值指示剂、检测尿液中葡萄糖的葡萄糖氧化酶、检测隐血或红细胞的血红蛋白类过氧化酶等。
进一步的，在邻近的导尿管外表面、防护腔体内、易于开启的密封部件上的任一部位设置可用于判定正常值的比色标记。
本发明的有益效果是：
封闭导尿管尿液出口的止流部件及附近透明管壁可在及时判断导尿成功的前提下避免尿液流出，省却了接纳尿液的容器也同时保证了导尿管尿液出口处的干燥清洁，避免了插入引流尿袋接头时的尿液污染。
封闭尿液出口的防护腔体可使导尿管尾部长时间暴露在空气中而不被污染。疏水止流膜片上加入的干化学法尿液分析常用的变色反应物质不仅方便观察且可第一时间获取如潜血、白细胞等尿液生物化学数据，有助于及时发现并处理相关病情。
附图说明
图1：现有临床判断导尿成功的方式示意图
图2：现有临床引流袋接头连接前的尿液出口状态示意图
图3：本发明在实施例1中止流部件结构示意图
图4：本发明在实施例1中止流部件止流效果示意图
图5：本发明在实施例1中导尿管与引流袋接头安全连接示意图
图6：本发明在实施例2中导尿管尾部设有透明视窗的示意图
图7：本发明在实施例3中疏水止流膜片位于导尿管尾部端面示意图
图8：本发明在实施例4中导尿管尾部尿液出口位于防护腔体内示意图
图9：本发明在实施例5中比色标记设于易于开启的密封部件上示意图
图10：本发明在实施例6中的结构剖面示意图
图11：本发明在实施例6中的示意图
图12：本发明在实施例7中的示意图
图中：10.导尿管内腔；11.导尿管内腔内表面；110.导尿管内表面的环形凹陷；12.导尿管外表面；13.导尿管头部；130.尿液入口；14.导尿管尾部；140.尿液出口；1410.透明视窗；1411.导尿管尾部端面；15.导尿管中间部；4.弯盘；4a.尿液出口流出的尿液；4b.导尿管尾部端面滞留的尿液；4c.被阻止流动的尿液；5.引流袋接头；51.引流袋接头顶端；6.止流部件；61.固定壳体；62.疏水止流膜片；63.开启撕口；64.过渡部件；65.密封部件；650.防护腔体；66.通气膜片；67.比色标记；68.包装膜片；69.包装膜片撕口；610.筒状固定壳体；611.筒状固定壳体间断外翻部分；612.筒状固定壳体内表面；613.筒状固定壳体连续外翻部分。
具体实施方式
实施例1：一种止流型导尿管，包括与现有导尿管相同的结构，如图1所示，具有内表面11、外表面12的实体材料构成的中空的主体管路，管路中空为导尿管内腔10，包括使用时进入膀胱的头部13，留置于体外的尾部14及连接头部13与尾部14的中间部15，头部13设有尿液入口130，尾部14设有尿液出口140；本发明与现有导尿管的区别是，如图3所示，还包括设于导尿管尾部14的将导尿管内腔10对外封闭的阻止液体但不阻止气体通过的疏水止流膜片62；疏水止流膜片62外周密封连接有环形的固定壳体61构成止流部件6，固定壳体61与导尿管尾部14的导尿管内腔10内表面11密封连接。
导尿管尾部14的导尿管内腔10内表面11的局部向导尿管外表面12方向环形凹陷110，导尿管内表面11的环形凹陷110适形容纳固定壳体61并密封连接。
现有导尿管置入操作过程，如图1所示，将导尿管插入膀胱后，如果尿液4a从导尿管尾部14的尿液出口140流入弯盘4，则判断导尿成功；如图2所示，引流袋接头5需及时与导尿管对接，而由于开放式操作，尿液4b从尿液出口140流出时难以避免地会污染尿液出口140处的导尿管尾部端面1411，在其上滞留尿液4b，此滞留的尿液4b会使落在其中的空气中的微生物繁殖，再次插入引流袋接头5时则将微生物带入导尿管内腔10，逆行入侵膀胱导致感染。
如图4所示，本发明中距尿液出口140有一定安全距离的导尿管内腔10内的与导尿管内表面11密封连接的止流部件6阻止了尿液4c的流动。
如图5所示，当本发明连接引流袋接头5时，引流袋接头顶端51向止流部件6推进，所述安全距离是指当引流袋接头顶端51与导尿管内腔10内表面11已经密封接触时，尚未与止流部件6的疏水止流膜片62接触，这样的止流部件6与尿液出口140的距离为安全距离，继续推进引流袋接头5，其顶端51冲破止流部件6上的疏水止流膜片62，与导尿管内腔10连通，尿液流入引流袋。
实施例2：如图6所示，止流部件6附近区域的导尿管壁上设有透明视窗1410，便于观察是否有尿液到达，及时准确判断导尿是否成功。
实施例3：如图7所示，在导尿管尾部14与导尿管内腔10连通的尿液出口140被一疏水止流膜片62封闭，疏水止流膜片62外周边缘与导尿管尾部端面1411连接为一体。
实施例4：如图8所示，本发明的尿液出口140附近的一段导尿管尾部14被易于开启的密封部件65封闭，尿液出口140位于由易于开启的密封部件65密封形成的防护腔体650内。
所述易于开启的密封部件65可以是柔性膜片构成的袋状，与导尿管尾部14外表面12密封连接形成防护腔体650，也可以通过一与导尿管尾部14外表面12密封连接的过渡部件64密封连接从而形成上述防护腔体650，易于开启的密封部件65边缘上可设有开启撕口63；易于开启的密封部件65还可以由硬质的可开合的两个零件构成，开启之前此两个零件密封连接。
封闭尿液出口140的易于开启的密封部件65本身为气体易于通过的材质，如透气性好的纸质膜材或聚乙烯膜材等，也可在易于开启的密封部件65上设有至少一个通气膜片66，以防排气不畅而导致的尿液无法流到止流部件6位置，影响判断导尿是否成功。
实施例5：疏水止流膜片上加入干化学法尿液分析常用的变色反应物质，如尿常规检测中的pH值指示剂、检测尿液中葡萄糖的葡萄糖氧化酶、检测隐血或红细胞的血红蛋白类过氧化酶等，不仅方便观察且可第一时间获取如潜血、白细胞等尿液生物化学数据，有助于及时发现并及早辅助诊断、处理病情，如图9所示，相关正常值的比色标记67置于易于开启的密封部件65上。
进一步的，形成防护腔体650封闭尿液出口140的易于开启的密封部件65在使用前与导尿管的其他部分共同处于由包装膜片68密封而成的无菌包装内，包装膜片68上设有撕口69。
实施例6：如图10、图11所示，疏水止流膜片62连接筒状固定壳体610，筒状固定壳体610探入导尿管尿液出口140内一段距离，优先选用上述的安全距离，并与导尿管内腔10内表面11密封接触，使用时引流袋接头5与筒状固定壳体610的内表面612接触密封，本例中筒状固定壳体610的延伸部分在导尿管尿液出口140临近的导尿管外表面12间断外翻，包裹固定导尿管，为筒状固定壳体间断外翻部分611，利于手指把持，便于安装及取下。
实施例7：如图12所示，疏水止流膜片62连接筒状固定壳体610，本例中筒状固定壳体610的延伸部分在导尿管尿液出口140临近的导尿管外表面12连续外翻，包裹固定导尿管，为筒状固定壳体连续外翻部分613，进一步增强包裹固定效果，利于手指把持，便于安装及取下。

Claims (9)

1.一种止流型导尿管，包括具有内表面(11)、外表面(12)的实体材料构成的中空的主体管路，管路中空为导尿管内腔(10)，包括使用时进入膀胱的头部(13)，留置于体外的尾部(14)及连接头部(13)与尾部(14)的中间部(15)，头部设有尿液入口(130)，尾部设有尿液出口(140)；其特征在于，还包括设于导尿管尾部(14)的将导尿管内腔(10)对外封闭的阻止液体但不阻止气体通过的疏水止流膜片(62)；
所述疏水止流膜片设置于距所述尿液出口(140)有一定安全距离处；
所述安全距离是指当引流袋接头顶端(51)与所述内表面(11)已经密封接触时，尚未与所述疏水止流膜片(62)接触，这样的所述疏水止流膜片(62)与所述尿液出口(140)的距离为安全距离；
所述疏水止流膜片的阻水压力大于患者排尿时的膀胱内压；
至少疏水止流膜片(62)附近区域的导尿管壁为透明或目力可及的部分透明。
2.根据权利要求1所述的一种止流型导尿管，其特征在于，疏水止流膜片(62)外周密封连接有环形的固定壳体(61)构成止流部件(6)，固定壳体(61)与导尿管尾部(14)的导尿管内腔(10)内表面(11)密封连接。
3.根据权利要求1所述的一种止流型导尿管，其特征在于，疏水止流膜片(62)外周密封连接有环形的固定壳体(61)，导尿管尾部(14)的导尿管内腔(10)内表面(11)局部向导尿管外表面(12)方向环形凹陷(110)适形容纳固定壳体(61)并密封连接。
4.根据权利要求1所述的一种止流型导尿管，其特征在于，在导尿管尾部(14)与导尿管内腔(10)连通的尿液出口(140)被一疏水止流膜片(62)封闭，疏水止流膜片(62)外周边缘与导尿管尾部端面(1411)连接为一体。
5.根据权利要求1所述的一种止流型导尿管，其特征在于，尿液出口(140)的一段导尿管尾部(14)被易于开启的密封部件(65)封闭，尿液出口(140)位于由易于开启的密封部件(65)密封形成的防护腔体(650)内。
6.根据权利要求1、5任一项所述的一种止流型导尿管，其特征在于，尿液出口(140)的一段导尿管尾部(14)被易于开启的密封部件(65)封闭，封闭尿液出口(140)的易于开启的密封部件(65)本身为气体易于通过的材质。
7.根据权利要求1、5任一项所述的一种止流型导尿管，其特征在于，尿液出口(140)的一段导尿管尾部(14)被易于开启的密封部件(65)封闭，封闭尿液出口(140)的易于开启的密封部件(65)上设有至少一个通气膜片(66)。
8.根据权利要求1-5任一项所述的一种止流型导尿管，其特征在于，疏水止流膜片(62)上加入干化学法尿液分析常用的变色反应物质。
9.根据权利要求8所述的一种止流型导尿管，其特征在于，疏水止流膜片上加入干化学法尿液分析常用的变色反应物质，还包括设置在邻近的导尿管外表面(12)、防护腔体(650)内、易于开启的密封部件(65)上的任一部位的用于判定正常值的比色标记(67)。
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