CN112843494B - 女性尿路梗阻β粒子治疗仪 - Google Patents
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Abstract
本发明涉及一种医疗器械，更确切的说是一种β粒子腔内治疗器械，专门用于治疗中老年女性的尿路梗阻疾病，称谓“女性尿路梗阻β粒子治疗仪”。该治疗仪由治疗头和控制器两大部件组成。其中治疗头含有导管(由上导管和下导管组成)，放射源，照射窗，滑动保护套(由保护套管、微动开关和滑块组成)以及手柄等零件。治疗头的导管内镶嵌有β放射源，可以在B超引导下通过尿道插入女性尿路梗阻或病变部位实施治疗。本发明的治疗仪具有操作简便，疗效显著，使用安全，移动灵活等优点。是一种无痛苦，无创伤，无副作用，患者易于接受的新疗法。
Description
技术领域：
本发明涉及一种医疗器械，更确切的说是一种β粒子腔内治疗器械，称谓“女性尿路梗阻β粒子治疗仪”。该治疗仪属于近距离治疗器械的范畴，专门用于治疗中老年女性的尿路梗阻疾病。
背景技术
女性尿路梗阻、尿失禁是中老年女性的常见病和多发病。
女性膀胱颈梗阻又称膀胱颈硬化症、Marion病或膀胱颈挛缩。因为中老年女性膀胱颈部增厚、硬化及松弛，导致患者排尿困难：尿频、尿急、尿失禁、尿潴留等现象。这类病的发病率与年龄成正比，若不及时诊治，晚期可导致上尿路扩张、肾积水、肾功能损害等。严重影响患者的生活质量。
2.1临床观察
临床观察表明，女性尿路梗阻发病年龄大多为30岁以上的女性患者，且多发生于已婚生育过的妇女。在女性排尿异常疾病中大约占2.7％--8.0％。患者主要出现进行性排尿困难：尿流变细、排尿费力、尿滴沥，膀胱剩余尿增多，尿频、尿急等。上述症状类似于男性前列腺增生症。梗阻严重时还会致排尿困难，甚至产生尿潴留，进而引起肾积水和充溢性尿失禁等。
2.2病因分析
女性膀胱颈梗阻的病因目前尚不十分清楚，一般认为有以下几种原因所致：
1.可能为炎症、非炎症或老化现象所致膀胱颈纤维组织增生、膀胱颈部肌肉肥厚或慢性炎症所致的硬化以及老年女性激素平衡失调导致的尿道周围腺体增生等。
2.膀胱颈部纤维组织增生，局部增厚弹性降低，膀胱颈部硬化及松弛。
3.因局部组织结构中发现有形成胶原蛋白的成纤维细胞而推测本病为结缔组织病。
4.先天性畸形，尤其是膀胱颈神经、肌肉结构不良或早期神经损害或阴道、尿道和膀胱颈手术后继发形成膀胱颈硬化等。
2.3治疗方法
公认公知的常规治疗方法有药物治疗，手术治疗和物理治疗。
1、药物疗法：长期口服α-受体阻滞药物，激素疗法。
2、膀胱颈部电切术：对保守治疗无效者可采用电切手术，优点是可以有效解除患者症状，但要求医生技术熟练、手术精准，因为电切术好坏会严重影响术后效果。另外，术后可能会出现出血、感染甚至狭窄等现象。
3、经闭孔尿道中段悬吊手术：尿失禁患者常常采用该手术治疗，但此类手术不仅难度大，有创伤，术后常常导致下腹部不适，产生牵拉性疼痛及腹股沟痛，甚或造成阴道损伤，或出现新发尿频、尿急、排尿困难，瘢痕组织增生。此外，术后也易并发感染，出血，膀胱颈狭窄，复发等并发症给患者带来痛苦和不便。
4、物理疗法：常规物理疗法包括热疗，针灸等。物理治疗可缓解症状，但复发率高，难以彻底治愈。
发明内容
本发明的女性尿路梗阻β粒子治疗仪是利用高能β粒子的电离效应，在B超引导下实施靶向治疗，经精确计算后给予适当的治疗剂量，使生理旺盛的微血管发生闭塞，促使膀胱颈部纤维细胞凋亡，进而使增生的纤维组织产生萎缩和其他退行性改变，达到治疗的目的。
本发明的β粒子治疗仪包括治疗器和控制器两大部件。其中治疗头含有导管(由上导管和下导管组成)，放射源，照射窗，滑动保护套(由保护套管、微动开关和滑块组成)以及手柄等零件。
本发明的β粒子治疗仪所用治疗头，导管外径为6mm，头部略呈圆锥状。治疗头总长度为200-240mm，活性区长度为20-30mm。Sr-90/Y-90(β)密封放射源镶嵌在上导管的活性区段，放射性活度控制在25-30mCi。治疗头从尿道口插入，可进行360度照射尿路梗阻或病变组织。
本发明的β粒子治疗仪选用不锈或Ti作导管材料，照射窗材料选用纯Ti，壁厚为0.5mm。
本发明的β粒子治疗仪，其保护套管的材料选用W-Ni合金；依靠滑块使保护套管能自由滑动，用于非治疗期间照射窗的保护和放射源的屏蔽。
本发明的β粒子治疗仪，控制器与治疗头上的微动开关相连接，以实施β粒子治疗所需吸收剂量的自动控制。
本发明的β粒子治疗仪在临床治疗时可借助”B超”引导治疗头的照射窗(活性区段)插入尿道病变部位，以实施精准治疗。
本发明的β粒子治疗仪由于利用90Sr的子体90Y放射的高能β粒子(在组织内的最大射程为11mm)，轫致辐射的剂量份额较低(＜2％)，在治疗剂量范围不会对深度组织和临近脏器造成辐射损伤，可确保治疗的安全性。
本发明的女性尿路梗阻β粒子治疗仪具有操作简便，疗效显著，安全可靠，移动灵活等优点。是一种无痛苦，无创伤，无副作用，易于为患者接受的新疗法。
附图说明
图1为女性尿路梗阻β粒子治疗仪的治疗头结构图。
其中1.上导管，2.照射窗，3.放射源，4.保护套管，5.下导管，6.微动开关，7.滑块，8.手柄。
具体实施方案
本发明的女性尿路梗阻β粒子治疗仪，治疗头的外形设计呈笔型。试验中所用治疗头的导管外径为6mm，头部略呈圆锥状。治疗头总长度为220--240mm，活性区长度为20-30mm。Sr-90/Y-90(β)密封放射源镶嵌在上导管的活性区段，放射性活度控制在25-30mCi。治疗头外部含有保护套管和手柄。
所用控制器，其面板上设置有液晶显示屏，并有″预置″，″治疗″、和″检测“等功能按钮，可事先快速设定达到所需吸收剂量的照射时间。
在具体实施照射治疗时，患者可取截石位，常规消毒外阴，铺孔巾，尿道粘膜浸润麻醉后，注入5ml灭菌石蜡。然后从屏蔽铅罐中取出治疗头，经消毒后，在B超经腹部引导下缓缓插入患者尿道，将上导管的活性区段准确定位于尿道部，此时滑动保护套由原位徐徐后退(照射时治疗头可固定在支架上)。一旦治疗头定位，立即触动保护套管上的微动开关，控制器里“治疗“指示灯即发出闪烁，示意照射开始，液晶显示屏不断呈现倒计时状态。当液晶显示“0”秒时，控制器会发出声，光报警，示意照射结束。将治疗头从患者尿道口取出后，可放入冲水器内用水冲洗一下，凉干后放回屏蔽铅罐中备用。
在治疗时，总的表面吸收剂量控制在40-50Gy，可一次性给足或分2-3次给予表面吸收剂量(根据患者病情确定)。初步临床观察表明，该法获得了明显的的治疗效果。
本发明的治疗仪适用范围为：1、女性膀胱颈增生；2、膀胱颈部硬化；3、膀胱颈部梗阻导致的类似前列腺增生症状：尿频，尿急，尿失禁，排尿困难，对反复尿路感染均有疗效。
Claims (3)
1.一种女性尿路梗阻β粒子治疗仪，其特征在于，所述治疗仪包括治疗头和控制器，所述治疗头包括导管、90Sr/90Yβ密封放射源、照射窗和滑动保护套，所述导管由上导管和下导管组成，所述导管外径为6mm，所述治疗头的总长度仅为200-240mm，所述治疗头的活性区长度为20-30mm，90Sr/90Yβ密封放射源镶嵌在所述上导管的活性区，放射性活度控制在25-30mCi，照射的立体角为360度；所述照射窗的材料为纯Ti，所述照射窗的壁厚为0.5mm；所述滑动保护套包括保护套管和滑块，所述保护套管的材料为W-Ni合金；所述保护套管依靠滑块滑动，用于在非治疗期间对照射窗进行保护和屏蔽放射源；所述控制器用于设定达到吸收剂量的照射时间；在治疗时借助B超引导，将所述上导管的活性区定位于尿道。
2.如权利要求1所述女性尿路梗阻β粒子治疗仪，其特征在于，所述治疗头的头部呈圆锥状。
3.如权利要求1所述女性尿路梗阻β粒子治疗仪，其特征在于，所述控制器的面板上包括液晶显示屏。
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1104923A (zh) * | 1994-11-02 | 1995-07-12 | 中国原子能科学研究院 | 经尿道治疗前列腺增生的β治疗器 |
| CN1130093A (zh) * | 1995-03-01 | 1996-09-04 | 中国原子能科学研究院 | 球囊型前列腺增生β射线治疗器 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1104923A (zh) * | 1994-11-02 | 1995-07-12 | 中国原子能科学研究院 | 经尿道治疗前列腺增生的β治疗器 |
| CN1130093A (zh) * | 1995-03-01 | 1996-09-04 | 中国原子能科学研究院 | 球囊型前列腺增生β射线治疗器 |
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