CN105877870A - 治疗男性尿失禁的新型尿道夹 - Google Patents
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Abstract
本发明公开了一种治疗男性尿失禁的新型尿道夹,包括合拢固定组装使用的第一支夹和第二支夹;第一支夹包括第一塑胶弹片,第一表层软质海绵介质,第一手柄,设有中心孔槽的第一柱状空心连接件;第二支夹包括第二表层软质海绵介质,第二塑胶弹片,第二柱状空心连接件,弹性卡齿,第二手柄。本发明的尿道夹生产工艺简单,生产成本低廉;尿道夹装置和技术治疗男性尿失禁医疗成本低;无需人造材料植入人体;控尿效果确切,排尿操作简单;前期尿道改造手术创伤非常小,成功率高,操作简单;不影响阴茎感觉和海绵体勃起功能;不影响患者阴茎外观;患者容易接受该方法和装置。
Description
技术领域
本发明涉及医疗器械技术领域,具体地指是一种治疗男性尿失禁的新型尿道夹。
背景技术
男性尿失禁通常发生于人体外伤或者外科手术后,比如严重骨盆骨折合并尿道外括约肌损伤等,但是最为常见的男性尿失禁还是发生于外科手术后,比如经过尿道前列腺电切术,前列腺癌根治术,膀胱根治性切除术,尿道狭窄切开术,前列腺放疗,以及先天畸形尿道括约肌缺如等。
经过尿道前列腺电切术是治疗老年男性良性前列腺增生的标准手术,如果手术切除技术掌握或者控制不好,损伤尿道括约肌,可能发生真性尿失禁,表现为,尿液无法控制而自行从尿道流出。前列腺癌根治术也可能因为肿瘤侵犯范围过大或者切除范围过大而发生括约肌损伤而发生尿失禁。根治性膀胱切除的手术范围包括男性前列腺切除部分,如果肿瘤侵犯范围过大或者切除范围过大而发生括约肌损伤而发生尿失禁。
尿失禁给患者带来极大不便,患者不得不长期穿带纸尿裤和尿不湿,无法离开家门,对于患者的心理和生理产生极大影响,也是医疗纠纷和医患关系紧张的重要来源之一。对于年轻尿失禁患者几乎丧失工作的勇气,影响性生活甚至导致家庭破裂。
男性尿失禁是当今外科学界世界性难题,现有的手术方法和器械无法完全解决,并且医疗成本和并发症十分明显。严重骨盆骨折后合并尿道外括约肌损伤,以及各种涉及尿道括约肌结构的手术类型都有可能导致男性尿失禁。目前医学上现有男性尿失禁的治疗和康复方法,包括:①提肛运动训练,括约肌功能恢复;②男性人工尿道吊带置入;③使用阴茎夹完全夹闭整个阴茎远端;④人工尿道括约肌植入术;⑤膀胱粘膜重建括约肌和韧带悬吊手术;⑥膀胱颈硬化剂注射。
经典阴茎夹工作示意图(将整个阴茎完全夹闭)(图1);人工尿道括约肌植入术示意图(植入人体的装置复杂,手术操作复杂,成本高)(图2);这些方法或者器械都存在显著的缺陷,包括无法真正解决尿失禁而只能达到定程度的缓解,现有的解决男性尿失禁的手术步骤复杂并发症多,或者器械结构复杂,存留人体内容易发生感染和排斥等。
①提肛运动训练和盆底生物反馈神经电刺激:回顾性研究证实这些方法属于理疗康复训练范围,对于真性尿失禁无法从单纯的肌肉训练这种方法得到完全治愈;
②男性人工尿道吊带置入:将人工材料作为补片植入人体将男性尿道球部悬吊治疗括约肌损伤导致的尿失禁。这种方法对于严重的真性尿失禁无法实现有意识控尿,而且吊带植入的松紧程度可以导致完全无法控尿,或者尿液无法排出。异物材料的植入存在导致组织炎症溃烂和组织排斥反应的可能,潜在危险明显。
③阴茎夹:其工作原理是通过类似橡胶弹性束带,将阴茎整体,包括尿都海绵体,阴茎海绵体,皮肤神经血管等完全捆扎实现封闭尿道阻止尿液溢出的作用。在排尿时松开约束带,让尿液流出。阴茎夹由于完全捆扎整个阴茎,包括阴茎的基本结构如血管,神经,筋膜等均长时间严重捆扎,仅仅再排尿的瞬间开放恢复血流和感觉。这个技术容易导致远端阴茎整体血液循环障碍,可能导致阴茎感觉麻木,阴茎勃起功能障碍,甚至可以导致夹闭的约束带的远端阴茎组织坏死,潜在危害巨大。长期夹闭整个阴茎还可以导致阴茎麻木,无法实现阴茎勃起,而完全失去性交能力;
④人工尿道括约肌植入术:人工尿道括约肌植入术被认为是治疗前列腺切除术后尿失禁的金标准。然而,即使是有经验的医生,仍然有超过35%的失败率。且该方法需要把整套装置通过手术方法植入人体,其手术过程复杂不易掌握和推广,医疗成本高,异物植入人体发生感染和排斥的机会很多;
⑤膀胱粘膜重建括约肌和韧带悬吊手术:手术效果差,控尿不理想,手术创伤范围很大;
⑥膀胱颈硬化剂注射:手术创伤确实不大,但是控尿效果差,硬化剂注入人体后局部炎症反应,组织坏死等副作用多。
发明内容
上述手术方式治疗男性尿失禁缺陷明显,无法十分有效地解决男性真性尿失禁疾病,或者手术步骤复杂,手术创伤很大,这些都限制了男性尿失禁患者的治疗效果,无法实现简单,有效地彻底解决男性尿失禁问题。本发明的目的先通过小手术改变男性尿道结构,在此基础上提供一种选择性夹闭尿道而实现可控排尿的治疗男性尿失禁的新型尿道夹。
为实现上述目的,本发明提供的治疗男性尿失禁的新型尿道夹,其特征在于:包括包括合拢固定组装使用的第一支夹和第二支夹;
所述第一支夹包括第一塑胶弹片,第一表层软质海绵介质,第一手柄,设有中心孔槽的第一柱状空心连接件;所述塑胶弹片与手柄一体成型呈Z形;所述塑胶弹片的内凹面与表层软质海绵介质连接,所述塑胶弹片与手柄连接部与柱状空心连接件连接;
所述第二支夹包括第二表层软质海绵介质,第二塑胶弹片,第二柱状空心连接件,弹性卡齿,第二手柄;所述第二塑胶弹片与第二手柄一体成型,所述第二塑胶弹片的外凸面与第二表层软质海绵介质连接,所述第二塑胶弹片与第二手柄的连接部与第二柱状空心连接件连接,所述第二柱状空心连接件的外壁设有多个与中心孔槽相配合的弹性卡齿。
作为优选方案,所述尿道夹采用高分子弹性聚乙烯材料,所述第一支夹和第二支夹均为一次成型浇模成型。
本发明使用之前先通过手术改造尿道结构:将男性阴茎根部切开皮肤,将该部位局部尿道海绵体从阴茎海绵体分离开,将阴茎表面皮肤皮瓣延伸并覆盖手术创面,在阴茎根部形成类似戴耳环穿耳洞的形态。通过特制的尿道夹简单夹拢和松开完全被皮肤覆盖的尿道海绵体,而实现随意控制尿液排出的目的。
本发明的优点在于:前期手术创伤非常小,成功率高,操作简单;不影响阴茎感觉和海绵体勃起功能,也无需人造材料植入人体。本发明能选择性夹闭尿道的控尿效果确切,排尿操作简单,也不影响阴茎外观,不影响阴茎海绵体勃起。具体优点如下:
①特制的尿道夹生产工艺简单,生产成本低廉;②尿道夹装置和技术治疗男性尿失禁医疗成本低;③无需人造材料植入人体;④控尿效果确切,排尿操作简单;⑤前期尿道改造手术创伤非常小,成功率高,操作简单;⑥不影响阴茎感觉和海绵体勃起功能;⑦不影响患者阴茎外观;⑧患者容易接受该方法和装置。
附图说明
图1是经典阴茎夹工作示意图。
图2是人工尿道括约肌植入术示意图。
图3是正常人阴茎主要结构横截面图。(将阴茎腹侧朝上)(0.1:尿道腹侧皮肤和筋膜,0.2:尿道腔,0.3:尿道海绵体,0.4:阴茎海绵体)
图4是阴茎腹侧手术切口设计图。(1.1:阴茎腹侧表面皮肤,1.2:尿道海绵体旁间隙体表皮肤切口投射区,1.3:阴茎皮肤和筋膜下的海绵体)
图5是尿道海绵体与阴茎海绵体局部分离手术设计图。(局部横截面)(0.1:尿道腹侧皮肤和筋膜,2.2:切口皮肤游离后包绕转折,2.3:尿道海绵体和阴茎海绵体局部分离界面,0.4:阴茎海绵体)
图6是尿道海绵体与阴茎海绵体局部分离并皮肤化后手术图一(局部横截面)(0.1:尿道腹侧皮肤和筋膜,0.2:尿道腔,3.3:穿过尿道海绵体和阴茎海绵体分离间隙并包绕海绵体的皮肤,0.4:阴茎海绵体)
图7是尿道海绵体与阴茎海绵体局部分离并皮肤化后手术图二(大体观侧面)(4.1:耻骨联合皮肤,4.2:阴囊,4.3:尿道海绵体和阴茎海绵体分离间隙,3.4:穿过尿道海绵体和阴茎海绵体分离间隙并包绕覆盖海绵体的皮肤,4.5:阴茎腹侧皮肤,0.4:阴茎海绵体,4.7:尿道)
图8是本发明尿道夹的结构示意图一。
图9是本发明尿道夹的结构示意图二。
图10是本发明尿道夹工作图示截面图。(1:塑胶弹片,2:尿道夹柱状空心连接件,3:表层软质海绵介质,4:挤压关闭的尿道,0.4:阴茎海绵体)
具体实施方式
以下结合附图和具体实施例对本发明作进一步的详细描述。
图9-10中所示的治疗男性尿失禁的新型尿道夹,包括包括合拢固定组装使用的第一支夹1和第二支夹2;
第一支夹1包括第一塑胶弹片11,第一表层软质海绵介质12,第一手柄13,设有中心孔槽140的第一柱状空心连接件14;第一塑胶弹片11与手柄13一体成型呈Z形;第一塑胶弹片11的内凹面与表层软质海绵介质12连接,第一塑胶弹片11与手柄13连接部与柱状空心连接件14连接;
第二支夹2包括第二表层软质海绵介质21,第二塑胶弹片22,第二柱状空心连接件23,弹性卡齿24,第二手柄25;第二塑胶弹片22与第二手柄25一体成型,第二塑胶弹片22的外凸面与第二表层软质海绵介质21连接,第二塑胶弹片22与第二手柄25的连接部与第二柱状空心连接件23连接,第二柱状空心连接件23的外壁设有多个与中心孔槽140相配合的弹性卡齿24。尿道夹采用高分子弹性聚乙烯材料,第一支夹1和第二支夹2均为一次成型浇模成型。
外科手术步骤
1、消毒男性会阴部手术范围,并自尿道外口置入18F气囊尿管至膀胱;2、在阴茎根部腹侧靠近阴囊部位触及尿道海绵体和阴茎海绵体两侧的交界处,沿阴茎纵轴切开皮肤,切口约2到3厘米,分离皮下筋膜,显露尿道海绵体和阴茎海绵体;3、钝性分离尿道海绵体和阴茎海绵体间隙直至完全游离一段尿道海绵体;4、将腹侧皮肤包饶尿道海绵体缝合;5、将阴茎海绵体两侧皮肤向海绵体两侧游离,使得皮肤稍微松弛后,两侧皮肤切口在尿道海绵体和阴茎海绵体之间间隙缝合;6、观察皮肤血运良好后无菌凡士林纱布覆盖切口;7、留置尿管一周,等待皮肤切口完全癒合。(见附图)
步骤一:前期的男性尿道手术改造方法说明
1、消毒男性会阴部手术范围,并自尿道外口置入18F气囊尿管至膀胱;2、在阴茎根部腹侧靠近阴囊部位触及尿道海绵体和阴茎海绵体两侧的交界处,沿阴茎纵轴切开皮肤,切口约2到3厘米,分离皮下筋膜,显露尿道海绵体和阴茎海绵体;3、钝性分离尿道海绵体和阴茎海绵体间隙直至完全游离一段尿道海绵体;4、将腹侧皮肤包饶尿道海绵体缝合;5、将阴茎海绵体两侧皮肤向海绵体两侧游离,使得皮肤稍微松弛后,两侧皮肤切口在尿道海绵体和阴茎海绵体之间间隙缝合;6、观察皮肤血运良好后无菌凡士林纱布覆盖切口;7、留置尿管一周,等待皮肤切口完全癒合。
步骤二:尿道夹制备:
采用计算机辅助设计的方法,或者3D打印的方法制备尿道夹,根据患者尿道尺寸设计不同大小的尿道夹。医用硅胶高分子材料,设计模具浇铸一次成型。
步骤三:尿道夹使用方法:
将尿道夹的第一支夹1和第二支夹2通过连接件扣紧;捏住两个手柄分开第一支夹1和第二支夹2部件的弹片部分;将第一支夹1或第二支夹2的弹片(第一塑胶弹片11和第二塑胶弹片22)从尿道孔插入,松开手柄即可压迫尿道控尿;调整第一支夹和第二支夹连接扣件的距离可以调整弹片压迫尿道的压力,实现在不同患者,不同尿道压力下的控尿。
本装置和技术能够彻底改变男性尿失禁的治疗现状,能够理想地解决男性尿失禁难题,是该领域地世界首创。
该装置疗效评价标准:文献报道尿失禁治愈的标准为不再需要使用尿垫或减少到每天使用1-2个尿垫。此外尿垫使用量、国际前列腺症状评分表(internationalprostatescoringsystem,IPSS)的生活质量评分及对尿道夹控尿效果的满意度(对效果感受分为非常满意、满意、一般、不满意及非常不满意)。
所述尿道夹采用对人体无毒害的高分子弹性聚乙烯材料,一次成型浇模成型。两个部件合拢固定组装使用。
Claims (2)
1.一种治疗男性尿失禁的新型尿道夹,其特征在于:包括包括合拢固定组装使用的第一支夹(1)和第二支夹(2);
所述第一支夹(1)包括第一塑胶弹片(11),第一表层软质海绵介质(12),第一手柄(13),设有中心孔槽(140)的第一柱状空心连接件(14);所述第一塑胶弹片(11)与手柄(13)一体成型呈Z形;所述第一塑胶弹片(11)的内凹面与表层软质海绵介质(12)连接,所述第一塑胶弹片(11)与手柄(13)连接部与柱状空心连接件(14)连接;
所述第二支夹(2)包括第二表层软质海绵介质(21),第二塑胶弹片(22),第二柱状空心连接件(23),弹性卡齿(24),第二手柄(25);所述第二塑胶弹片(22)与第二手柄(25)一体成型,所述第二塑胶弹片(22)的外凸面与第二表层软质海绵介质(21)连接,所述第二塑胶弹片(22)与第二手柄(25)的连接部与第二柱状空心连接件(23)连接,所述第二柱状空心连接件(23)的外壁设有多个与中心孔槽(140)相配合的弹性卡齿(24)。
2.根据权利要求1所述的治疗男性尿失禁的新型尿道夹,其特征在于:所述尿道夹采用高分子弹性聚乙烯材料,所述第一支夹(1)和第二支夹(2)均为一次成型浇模成型。
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