CN105769380A - 骨盆腔内膀胱底外支架和植入方法 - Google Patents

骨盆腔内膀胱底外支架和植入方法 Download PDF

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CN105769380A
CN105769380A CN201610365490.4A CN201610365490A CN105769380A CN 105769380 A CN105769380 A CN 105769380A CN 201610365490 A CN201610365490 A CN 201610365490A CN 105769380 A CN105769380 A CN 105769380A
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bladder
fundus
pelvic cavity
support arm
pubis
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CN105769380B (zh
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周建
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Liaoning Weng Ling Medical Technology Co Ltd
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Individual
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Priority to US16/304,088 priority patent/US10952835B2/en
Priority to PCT/CN2017/085812 priority patent/WO2017206783A1/zh
Priority to JP2019516043A priority patent/JP6689556B2/ja
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Abstract

本发明公开了一种骨盆腔内膀胱底外支架和植入方法，根据中医中气不足导致五脏六腑下坠的理论发明。骨盆腔内膀胱底外支架通过后端设置在膀胱外底部位和前端固定到骨盆耻骨梳部位抬升下坠体的方法消除膀胱以下骨盆腔内脏器相互挤压损伤出现的群病灶，恢复脏器功能，实现精准医疗，切实提高人类中老龄时期的生存质量和寿命。骨盆腔内膀胱底外支架结构内部设置有注射通道，输入孔端设置有螺口可连接到体外设备。骨盆腔内膀胱底外支架使用断层扫描三维立体建模技术生成完全符合特征个人骨盆耻骨梳和膀胱外底生理形状和腹腔空间形态的模型文件，并打印成医用材料质量的框架结构的骨盆腔内膀胱底外支架。术前采用虚拟现实技术模拟验证手术安全方案。

Description

骨盆腔内膀胱底外支架和植入方法
技术领域
本发明公开了一种通过外科手术植入的骨盆腔内膀胱底外支架。用于改善内气不足时导致五脏六腑下坠引起的生理机能和功能下降，涉及人类老年性疾病，中医生理内气理论和医案，西医生理解剖学和外科支架植入技术，医用三维立体打印技术领域。公知中医生理理论中有“中气不足时会导致五脏六腑下坠”的论述，人生的中气不足多发于人50岁之后的老年阶段，是每个人都无法逾越的生命进程。“中气”是“内气”的中医生理学分类学定义之一，中焦之气，不只是指脾胃之气。内气的“气”古人写成：炁，与呼吸之气和五谷之氣相区别，表示“炁”这个生命层次的物质客观存在于人类生命中(以下文中均用“气”，代表炁字)，并作用于人类生命的全过程。内气之源称为元气，既先天之气；元气是某特征生命起源时大自然赋予的寿命燃料。元气的质与量是生命体存在的那一刻起就已经确定，随着年龄增长而耗尽，中气不足是元气耗尽前的一个量变阶段。为此古人有通过补益脾胃之气来充盈后天之气“重在茹素、少食、不冷食”的保中气之法，更有经典验方《补中益气方》调整中气不足。由于《补中益气方》所补之气是后天之气，不是先天之气。后天之气与先天之气存在本质上差异，所补后天之气只能相对阻止后天耗损之气不再蚕蚀先天之气，不能完全替代和补充先天之气的损耗。来源于药物的后天之气，在药物半衰期的规律作用下，人需要长期服用和递增药量才能让后天之气暂时够用。尽管如此，人类生命的中气必将耗尽是客观事实，终有不可救药的痛苦时段伴随余生。每个人当中气不足时会导致五脏六腑下坠，在骨盆腔和泌尿生殖隔的阻止下五脏六腑在腹膜内外发生相互挤压引起各器官组织和功能损伤，呈现非孤立状态的群病灶(见图1)。
本发明涉及到公知的西医生理解剖学，其理论中没有认识到“气”这个生命物质在人类生命中的客观存在。因此，把表象群病灶割裂开来定性，虽有老年综合征之定义，也只能对表象病灶按解剖学分门别类加以论治，把各脏器血循环不畅造成的血瘀归结为局部炎症，施于靶向药物导致定向脏器坏死，施于广谱药物时又导致副作用损伤，施于外科切除坏死组织症状后功能障碍无法避免，表明其科学性明显存在不足，基础理论存在错误，致使诊断治疗错误。
本发明涉及到公知的西医人体内支架外科手术植入技术和方法。由于在本发明之前西方医学界对腹腔中脏器下坠出现的群病灶没有正确地认知，所以外科支架植入技术中没有使用骨盆腔内膀胱底外支架植入的专门技术和方法。
本发明涉及到公知的医用断层扫描和三维立体数据重建技术和三维立体打印技术领域，使用公知的医用金属、陶瓷及塑料材料的打印技术来制造个性化的骨盆腔内膀胱底外支架。
背景技术
近现代中医学中对中气不足认识普遍停留在《内经》“人以水谷为本”的宗旨，以“人以胃气为本”的思想为基础，着力阐发“内伤脾胃，百病由生”的病机理论，倡导培补脾土、潜降阴火的治则思想，形成较为系统的脾胃内伤病的辨证论治理论体系，及李东垣《脾胃论》定义的中气是指脾胃之气阶段，并没有足够的认识到人类老年至衰亡的生理特征中内气衰弱之时必然导致产生中气不足阶段。
使用公知的中国古代经典验方《补中益气》按脉相加减方治疗方法，用后天之气补益先天之气的消耗，可改善和减缓五脏六腑下坠程度维持数年，延缓到达不可救药阶段。年龄增长最终必将发生先天之气的中气不足至中气衰弱导致无法逆转地五脏六腑下坠，令老年人生存质量严重下降到无助的痛苦时期。由于现代中医理论在内气的验证研究方面手段西化结论出现否认倾向，因此没有使用骨盆腔内膀胱底外支架植入减压的方法来复原膀胱位置，消除群病灶中泌尿系统障碍的解决方案。
西医生理解剖学中公知的吴阶平《泌尿外科学》里有“新生儿的膀胱位置比成人高，尿道内口可达耻骨联合上缘水平，大部分位于腹腔内。即使处于排空状态膀胱顶部仍在耻骨联合上缘水平以上。随着年龄的增长，膀胱将逐渐降入骨盆内，青春期左右达成人的位置。……膀胱周围有盆筋膜及其形成的韧带对其起支持作用，维持膀胱在一正常水平。”的描述。只是找到了年龄增长膀胱位置产生下移的客观规律，并用筋膜及韧带松弛来解释这个规律的作用力，没有如古典中医学认识到膀胱位置产生下移的客观规律是人体内中气不足所致，更没有认识到随着年龄增长五脏六腑是同时下坠，只能针对泌尿系统论治，在切除前列腺之后仍不能恢复功能，还是要采用把导尿管插入尿道至膀胱的人工排尿方法，或者使用尿道内支架来替代自主功能，一步一步地破坏自主生态。在本发明之前西医学对腹腔中脏器下坠出现的群病灶没有正确地认知，所以外科支架植入技术中没有使用骨盆腔内膀胱底外支架植入的方法，没有使用复原膀胱位置来消除排泄系统障碍和弥补筋膜及韧带松弛的解决方案。
与本发明创造最接近的是泌尿系统医案中的尿道内支架植入技术，该技术和方法通过从尿道外口直接将金属支架植入尿道内，使其扩张前列腺和内外括约肌内部尿道实现人工协助排尿，不足之处是前列腺和内外括约肌功能丧失，异样感明显，易感染，不能消除腹腔中脏器下坠出现的群病灶，自主生态依然恶化的状况无法改善。尿道内支架植入技术不涉及腹腔手术技术和方法。本发明是通过植入骨盆腔内膀胱底外支架抬升膀胱，使内、外括约肌，前列腺和尿道不再承受挤压恢复原本的生理机能，并改善和恢复其他器官自主生态功能，有效地消除群病灶，纠正西医病理学中定义的老年综合征认识的错误。
公知的西医的体内支架植入技术已经比较成熟，但没有本发明的骨盆腔内膀胱底外支架和植入方法的相同和近似的专利技术。
公知的膀胱底尿道内植金属支架完全丧失了尿道的收缩关闭功能呈开放感染状态，其占位扩张力迫使男性的前列腺挤压直肠，女性则尿道直接挤压直肠，会造成粪便排泄困难和直肠脱垂。尿道内植金属支架只是起到人工扩张尿道释放尿液的作用。
公知的虚拟现实技术为本发明骨盆腔内膀胱底外支架和植入方法实现通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案的方法提供了基础理论和基础硬件。
发明内容
本发明的目的是提供一种骨盆腔内膀胱底外支架和植入方法，使腹腔内下坠的脏器实现复位，消除骨盆腔内脏器的挤压损伤，恢复各脏器的生理功能，切实提高人类中老龄时期的生存质量和寿命。
根据中医中气不足导致的五脏六腑下坠的理论，研究五脏在骨盆腔内发生相互挤压损伤出现群病灶的有效消除方法后发明骨盆腔内膀胱底外支架，通过后端设置在膀胱外底部位和前端固定到骨盆耻骨梳部位抬升下坠体的植入方法消除膀胱以下骨盆腔内脏器的挤压损伤，实现脏器功能恢复。骨盆腔内膀胱底外支架的制备使用公知的医用三维立体打印技术解决方案把腹部断层扫描数据转换成三维立体数据，通过三维立体建模软件修改骨盆腔内膀胱底外支架原型设计参数生成完全符合特征个人骨盆耻骨梳和膀胱外底生理形状和腹腔空间形态的骨盆腔内膀胱底外支架模型文件，并打印成医用材料质量的框架结构的个性化骨盆腔内膀胱底外支架实体。其特征为；骨盆腔内膀胱底外支架的整体结构由镜像结构相同的左右两片骨盆腔内膀胱底外支架和桥接器组装成型；镜像结构相同的左右两片骨盆腔内膀胱底外支架设置有耻骨梳上沿钩和螺钉孔，桥板和桥板耻骨联合缺口，桥接器固定孔，膀胱座和减压弧；桥板前端连接耻骨梳上沿钩，后端连接膀胱座，桥板设置成框架状曲面结构；前端设置有耻骨联合缺口，缺口外侧设置耻骨梳上沿钩，耻骨梳上沿钩曲面上设置有注射通道输入孔和螺钉孔；耻骨联合缺口处内侧设置有桥接器固定孔；膀胱座设置成符合膀胱颈结构的漏斗状，漏斗状的中心减压弧设置成避开膀胱括约肌形状，弧面上设置有注射通道输出孔；减压弧至耻骨梳上沿钩之间桥板断面中设置有注射通道，注射通道输入孔端设置有螺口，用于设置密封螺丝、电极或输送药物的体外连接器；桥接器设置成符合桥板曲面的门形长方体结构，长方体两端平面上分别设置一个具有防脱落结构的卡头。两卡头与两个桥接器固定孔配合连接固定左右两片骨盆腔内膀胱底外支架成整体。
植入前使用断层扫描装置采集特征个人腹腔数据；根据公知的吴阶平泌尿外科学中“新生儿的膀胱位置比成人高，尿道内口可达耻骨联合上缘水平，大部分位于腹腔内。即使处于排空状态膀胱顶部仍在耻骨联合上缘水平以上。随着年龄的增长，膀胱将逐渐降入骨盆内，青春期左右达成人的位置。”的描述，首先做人体站立体位腹腔断层扫描，获得脏器完全下坠时的三维空间位置数据；再做人体仰卧倒倾20～40度角体位腹腔断层扫描，获得模拟成人青春期前脏器未下坠时的三维空间位置数据，生成特征个人腹腔构造三维数据库，再转换成三维建模软件数据格式，创建该特征个人腹腔构造模型和修改原型设计参数后的骨盆腔内膀胱底外支架模型文件，通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案后，用医用三维立体打印机打印成型备用；手术操作人员需通过特征个人腹腔构造模型和修改原型设计参数后的膀胱外支架模型的打印件实习，获得验证地膀胱复位手术方案安全操作的全部数据。
骨盆腔内膀胱底外支架的植入位置在耻骨梳韧带下与耻骨梳上沿和耻骨梳外侧面，耻骨联合部位外侧，到膀胱外底和外括约肌之间。
植入方法为外科腹腔支架植入手术，在公知的腹腔手术方案做术前无菌处置完成后，把药液从注射通道输入孔注入，待输出孔无气体排出后，用专用螺丝密封输入孔螺口，保证术后药液随体温热胀时只能从注射通道输出孔渗出；再按术前验证地膀胱复位手术方案操作，对耻骨梳韧带与耻骨梳上沿进行无损伤组织剥离做出骨盆腔内膀胱底外支架的耻骨梳上沿钩可以植入的间隙，避开耻骨联合部位；
男性再对膀胱外底和外括约肌之间，膀胱外底后部与输精管壶腹之间进行无损伤组织剥离，做出骨盆腔内膀胱底外支架后端的膀胱座植入的间隙；
女性按公知医案摘除已经萎缩的子宫，缝合阴道内口和腹膜，使膀胱上部空间得到释放，再在膀胱外底后缘与阴道外壁连接处做无损剥离创建间隔，无法剥离者需要在此做阴道截断剥离保证膀胱座端能够植入和所需提升空间，再缝合阴道截断处开口；膀胱底前缘与耻骨、耻骨梳连接处做无损剥离时要避开阴蒂组织，保证左右两片骨盆腔内膀胱底外支架呈非接触状态连接固定时不压迫阴蒂组织；
分别将左右两片骨盆腔内膀胱底外支架沿耻骨梳上沿间隙插入，使耻骨梳上沿钩与左右耻骨梳上沿和外侧面完全吻合，使膀胱座与膀胱外底完全吻合并准确避开内括约肌；用医用电钻按耻骨梳上沿钩曲面设置的螺钉孔定位打孔，将医用螺钉把骨盆腔内膀胱底外支架固定到耻骨梳外侧面上，保证螺丝帽没有突起；再将打印成的桥接器两端的卡头分别按进桥板前端左右两个固定孔中，保证左右两片骨盆腔内膀胱底外支架之间呈非接触状态连接固定；
植入完成需按公知的腹腔手术方案做术后处置。
上述的减压弧至耻骨梳上沿钩之间桥板断面中设置有注射通道；当注射通道作为药物缓释体时可以储蓄部分药液，药液随体温热胀时自动从输出孔渗出，当注射通道内外压相等后自动停止渗出。
上述的注射通道输入孔端设置有螺口；当螺口处安装连接器后可从体外注入药物直达膀胱外底部位。
上述的注射通道输入孔设置有螺口；当螺口处安装体外连接器后能够作为施用物理方法的电极使用。
上述的通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案，具体方法是使用公知的虚拟现实技术，将多个VR虚拟三维眼睛和触感手术器具构建在虚拟手术台软件互动平台上，整合成手术模拟工程系统，手术操作人员通过手术模拟工程系统在虚拟现实环境内演习膀胱复位手术方案，直至得到最佳方法和效果。
本发明的积极效果：
本发明的骨盆腔内膀胱底外支架和植入方法能够纠正老年性疾病领域现存的错误疾病认识和治疗方案，正确弘扬和发展中医理论和实践成果，减少因错误造成的社会医疗资源和资金浪费，并能够切实提高人类中老龄时期的生存质量和生活信心。
当人体的内气在药物无能为力已至中气匮乏时，或中老年人因排泄障碍导致生存质量严重下降到无助的痛苦时期，应使用本发明的骨盆腔内膀胱底外支架和植入方法消除群病灶，从实质上改善和提升中老年人生存质量。
本发明设计的骨盆腔内膀胱底外支架和植入方法能够将膀胱提升到耻骨上沿位置阻止腹腔内脏器下坠，恢复各脏器功能。
漏斗状的中心减压弧保证释放下坠重力对内、外括约肌的压力，使副交感神经恢复正常感知和信号传递功能，不再挤压男性的前列腺、尿道和直肠，女性的尿道和直肠，有效减轻或消除泌尿及相关联系统的群病灶，恢复排泄功能。
膀胱提升到耻骨上沿位置后横结肠和膈肌得到了新的支撑，被阻止了下坠进程，使心、肺功能得以恢复和稳定。
膀胱提升到耻骨上沿位置后新的支撑上部使横结肠恢复到原来的上后部位置，空肠和小肠随之回位，腹膜得以减压，疝气消除；有效减少对膀胱的挤压力，膀胱上部空间增加，使尿液储纳量逐渐恢复到原来水平。
膀胱提升到耻骨上沿位置后新的支撑上部使胰腺和肾脏消除重力引起的向下的力基本回位，形状和功能得到恢复，阵发性尿糖和阵发性尿毒症逐渐消失。
膀胱提升到耻骨上沿位置后新的支撑上部使胆囊和肝脏消除重力引起的向下的力基本回位，因肝脏下坠受到拉长的胆囊形状和功能得到恢复，未熟胆汁不再外溢，黄尿和尿毒症状消失，熟化的胆汁使消化能力恢复，体内偏酸导致皮肤湿痒的症状消失。
膀胱提升到耻骨上沿位置后使上部的脏器基本回位，膀胱顶部空间得到恢复，尿液充盈时的容量随之增加和恢复；膀胱内三角区空间恢复后，尿液回溯增加肾脏内压现象消失；膀胱座承担支撑膀胱的作用，中心减压弧释放的空间使膀胱内、外括约肌不再承受膀胱被挤压时的重量，逼尿感知能力和神经传导控制功能得以恢复，尿短，尿频，尿急症状消失；精囊和输精管被挤压力消除，性功能恢复。
膀胱提升到耻骨上沿位置后使下部的前列腺空间还原，形状恢复，血液循环得以畅通，瘀血积液很快被代谢干净，炎症和肥大症状消除，内部经过的尿道恢复通畅，尿潴留症状消除，尿便时不再额外使劲用力，疝气症状消除；尿道球腺和射精管功能恢复，射精疼痛型性功能障碍及其引起的烦躁症状消除。
膀胱提升到耻骨上沿位置后使下部的泌尿生殖隔等组织形状和弹性恢复，不再挤压内部经过的尿道和外部的直肠，大小便交替潴留和排泄，直肠脱出，内痔外翻症状消除。
骨盆腔内膀胱底外支架的框架结构优点：采用三维立体打印技术制造成本低，节省材料，坚固质轻，吻合精度高，透气性结构可防止接触部位体液滞留引起的感染和组织坏死。
骨盆腔内膀胱底外支架的框架结构内部的注射通道具有输送和存储药液的功能，输入孔螺口端安装连接器后可从体外注入药物直达膀胱外底部；当注射通道作为药物缓释体时，可以储蓄部分药液，药液随体温热胀时自动从输出孔排出给药。输入孔螺口端安装连接器后还能够作为施用物理方法的电极使用。
手术操作人员通过使用虚拟现实技术整合成的手术模拟工程系统实习验证膀胱复位手术方案，能够保证每一个手术的精准质量和安全性。
附图说明
图1是本发明的群病灶时间表示意图。
图2是本发明的骨盆腔内膀胱底外支架的总成立体结构示意图。
图3是本发明的骨盆腔内膀胱底外支架的总成俯视结构示意图。
图4是本发明的骨盆腔内膀胱底外支架的左片俯视结构示意图。
图5是本发明的骨盆腔内膀胱底外支架的注射通道输入孔内螺口局部结构示意图。
图6是本发明的骨盆腔内膀胱底外支架的桥接器结构示意图。
具体实施方式
见图1，根据群病灶时间表所示，一般情况下人到50岁时脏器下坠就已经造成多个脏器功能下降，开始影响生存质量。剖腹产出生的人和年轻时做过腹腔手术的人出现脏器下坠的时间和程度要早于群病灶时间表所示时间，开始影响生存质量的时间多在50岁之前；坚持各种良好的体育、健身运动的人会在50岁之后开始影响生存质量；女性一般晚于男性。在知道脏器下坠时开始服用《补中益气》丸剂一般可以缓解下坠速度和程度，有效性与服用时初始年龄和体质及服用方法和剂量有关，可以维持延缓3到5年时间不等。公知的西医外科腹腔手术安全年龄段一般在60岁之前，建议在50岁左右时施用本发明骨盆腔内膀胱底外支架和植入方法，可以避免其后时间段内发生的痛苦。
当人体出现中气不足导致腹腔脏器下坠，在骨盆腔内发生相互挤压损伤出现群病灶时需要使用骨盆腔内膀胱底外支架和植入方法来消除。根据公知的吴阶平泌尿外科学中“新生儿的膀胱位置比成人高，尿道内口可达耻骨联合上缘水平，大部分位于腹腔内。即使处于排空状态膀胱顶部仍在耻骨联合上缘水平以上。随着年龄的增长，膀胱将逐渐降入骨盆内，青春期左右达成人的位置。”的描述，在植入前使用断层扫描装置采集特征个人腹腔数据。首先做人体站立体位腹腔断层扫描，获得脏器完全下坠时的三维空间位置数据；再做人体仰卧倒倾20～40度角体位腹腔断层扫描，获得模拟成人青春期前脏器未下坠时的三维空间位置数据，生成特征个人腹腔构造三维数据库，再转换成三维建模软件数据格式，创建该特征个人腹腔构造模型和修改原型设计参数后的骨盆腔内膀胱底外支架模型文件，通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案；方法是使用公知的虚拟现实技术，将多个VR虚拟三维眼睛和触感手术器具构建在虚拟手术台软件互动平台上，整合成手术模拟工程系统，手术操作人员通过手术模拟工程系统在虚拟现实环境内演习膀胱复位手术方案，直至得到最佳方法和效果。获得验证地膀胱复位手术方案全部的安全操作数据后，选择医用纳米金属陶瓷材料和制备工艺，采用医用级三维立体打印机打印出框架结构的骨盆腔内膀胱底外支架。
见图2、3、4、5、6，骨盆腔内膀胱底外支架的整体结构1，由镜像结构相同的左右两片1-L骨盆腔内膀胱底外支架和桥接器6组成；骨盆腔内膀胱底外支架结构中设置有耻骨梳上沿钩9和螺钉孔10，桥板和桥板耻骨联合缺口7，桥接器固定孔8，膀胱座2和减压弧3；耻骨梳上沿钩连接在桥板前端，桥板后端连接膀胱座；耻骨梳上沿钩设置在桥板耻骨联合缺口外侧，耻骨梳上沿钩表面设置有注射通道输入孔5和螺口5-2；桥板7设置成网状曲面结构，前端设置有耻骨联合缺口，耻骨联合缺口处设置有桥接器固定孔8，后端设置有膀胱座2，膀胱座设置成符合膀胱颈结构的漏斗状，漏斗状的中心减压弧3设置成避开膀胱括约肌形状，弧线上设置有注射通道输出孔4；桥板断面中设置有注射通道连接输入孔5和输出孔4。
见图3，设置在耻骨梳上沿钩表面的注射通道输入孔内喉管5-1为注射通道一部分，直径相同，喉管外连接有螺口5-2，用于设置电极或输送药物的体连接器。
见图4，桥接器6设置成符合桥板网状曲面结构的门形6-1结构，使用与耻骨联合韧带弹性、强度相同的尼龙塑料打印成型。门形结构上方的长方体两端平面上分别设置一个具有防脱落结构的卡头6-2。两卡头与两个桥接器固定孔配合固定连接成整体，保证骨盆腔内膀胱底外支架左右两片对称边之间具有固定间隙。
植入方法为外科腹腔支架植入手术，在公知的腹腔手术方案做术前无菌处置完成后，把药液从注射通道输入孔注入，待输出孔无气体排出后，用专用螺丝密封输入孔螺口，保证术后药液随体温热胀时只能从注射通道输出孔渗出；再按术前验证地膀胱复位手术方案操作，对耻骨梳韧带与耻骨梳上沿进行无损伤组织剥离做出骨盆腔内膀胱底外支架的耻骨梳上沿钩可以植入的间隙，避开耻骨联合部位；
男性再对膀胱外底和外括约肌之间，膀胱外底后部与输精管壶腹之间进行无损伤组织剥离，做出骨盆腔内膀胱底外支架后端的膀胱座植入的间隙；
女性按公知医案摘除已经萎缩的子宫，缝合阴道内口和腹膜，使膀胱上部空间得到释放，再在膀胱外底后缘与阴道外壁连接处做无损剥离创建间隔，无法剥离者需要在此做阴道截断剥离保证膀胱座端能够植入和所需提升空间，再缝合阴道截断处开口；膀胱底前缘与耻骨、耻骨梳连接处做无损剥离时要避开阴蒂组织，保证有左右两片骨盆腔内膀胱底外支架呈非接触状态连接固定时不压迫阴蒂组织的空间；
再分别将左右两片骨盆腔内膀胱底外支架沿耻骨梳上沿间隙插入，使耻骨梳上沿钩与左右耻骨梳上沿和外侧面完全吻合，使膀胱座与膀胱外底完全吻合；用医用电钻按耻骨梳上沿钩曲面设置的螺钉孔定位打孔，将医用沉头螺钉把骨盆腔内膀胱底外支架固定到耻骨梳外侧面上，保证螺丝帽不能有突起；再将打印成型的桥接器两端的卡头分别按进桥板前端左右两个固定孔中，保证左右两片骨盆腔内膀胱底外支架之间呈非接触状态连接固定；
植入完成再按公知的腹腔手术方案做术后处置。
注射通道输入孔螺口处安装连接器后可从体外注入药物直达膀胱外底部；当注射通道作为药物缓释体时可以储蓄部分药液，药物注入完毕密封连接器，保证药液随体温热胀时只能从输出孔渗出，当注射通道内外压相等后自动停止渗出。
注射通道输入孔螺口处安装连接器后能够作为施用物理方法的电极使用。

Claims (3)

1.本发明的目的是提供一种骨盆腔内膀胱底外支架和植入方法；骨盆腔内膀胱底外支架的整体结构由镜像结构相同的左右两片骨盆腔内膀胱底外支架和桥接器组装成型；镜像结构相同的左右两片骨盆腔内膀胱底外支架设置有耻骨梳上沿钩和螺钉孔，桥板和桥板耻骨联合缺口，桥接器固定孔，膀胱座和减压弧；桥板前端连接耻骨梳上沿钩，后端连接膀胱座，桥板设置成框架状曲面结构；前端设置有耻骨联合缺口，缺口外侧设置耻骨梳上沿钩，耻骨梳上沿钩曲面上设置有注射通道输入孔和螺钉孔；耻骨联合缺口处内侧设置有桥接器固定孔；膀胱座设置成符合膀胱颈结构的漏斗状，漏斗状的中心减压弧设置成避开膀胱括约肌形状，弧面上设置有注射通道输出孔；减压弧至耻骨梳上沿钩之间桥板断面中设置有注射通道，注射通道输入孔端设置有螺口，用于设置密封螺丝、电极或输送药物的体外连接器；桥接器设置成符合桥板曲面的门形长方体结构，长方体两端平面上分别设置一个具有防脱落结构的卡头；两卡头与两个桥接器固定孔配合连接固定左右两片骨盆腔内膀胱底外支架成整体；
植入前使用断层扫描装置采集特征个人腹腔数据；根据公知的吴阶平泌尿外科学中“新生儿的膀胱位置比成人高，尿道内口可达耻骨联合上缘水平，大部分位于腹腔内；即使处于排空状态膀胱顶部仍在耻骨联合上缘水平以上；随着年龄的增长，膀胱将逐渐降入骨盆内，青春期左右达成人的位置；”的描述，首先做人体站立体位腹腔断层扫描，获得脏器完全下坠时的三维空间位置数据；再做人体仰卧倒倾20～40度角体位腹腔断层扫描，获得模拟成人青春期前脏器未下坠时的三维空间位置数据，生成特征个人腹腔构造三维数据库，再转换成三维建模软件数据格式，创建该特征个人腹腔构造模型和修改原型设计参数后的骨盆腔内膀胱底外支架模型文件，通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案后，用医用三维立体打印机打印成型备用；手术操作人员需通过特征个人腹腔构造模型和修改原型设计参数后的膀胱外支架模型的打印件实习，获得验证地膀胱复位手术方案安全操作的全部数据；
骨盆腔内膀胱底外支架的植入位置在耻骨梳韧带下与耻骨梳上沿和耻骨梳外侧面，耻骨联合部位外侧，到膀胱外底和外括约肌之间；
植入方法为外科腹腔支架植入手术，在公知的腹腔手术方案做术前无菌处置完成后，把药液从注射通道输入孔注入，待输出孔无气体排出后，用专用螺丝密封输入孔螺口，保证术后药液随体温热胀时只能从注射通道输出孔渗出；再按术前验证地膀胱复位手术方案操作，对耻骨梳韧带与耻骨梳上沿进行无损伤组织剥离做出骨盆腔内膀胱底外支架的耻骨梳上沿钩可以植入的间隙，避开耻骨联合部位；
男性再对膀胱外底和外括约肌之间，膀胱外底后部与输精管壶腹之间进行无损伤组织剥离，做出骨盆腔内膀胱底外支架后端的膀胱座植入的间隙；
女性按公知医案摘除已经萎缩的子宫，缝合阴道内口和腹膜，使膀胱上部空间得到释放，再在膀胱外底后缘与阴道外壁连接处做无损剥离创建间隔，无法剥离者需要在此做阴道截断剥离保证膀胱座端能够植入和所需提升空间，再缝合阴道截断处开口；膀胱底前缘与耻骨、耻骨梳连接处做无损剥离时要避开阴蒂组织，保证左右两片骨盆腔内膀胱底外支架呈非接触状态连接固定时不压迫阴蒂组织；
分别将左右两片骨盆腔内膀胱底外支架沿耻骨梳上沿间隙插入，使耻骨梳上沿钩与左右耻骨梳上沿和外侧面完全吻合，使膀胱座与膀胱外底完全吻合并准确避开内括约肌；用医用电钻按耻骨梳上沿钩曲面设置的螺钉孔定位打孔，将医用螺钉把骨盆腔内膀胱底外支架固定到耻骨梳外侧面上，保证螺丝帽没有突起；再将打印成的桥接器两端的卡头分别按进桥板前端左右两个固定孔中，保证左右两片骨盆腔内膀胱底外支架之间呈非接触状态连接固定；
植入完成需按公知的腹腔手术方案做术后处置；
上述的减压弧至耻骨梳上沿钩之间桥板断面中设置有注射通道；当注射通道作为药物缓释体时可以储蓄部分药液，药液随体温热胀时自动从输出孔渗出，当注射通道内外压相等后自动停止渗出；
上述的注射通道输入孔端设置有螺口；当螺口处安装连接器后可从体外注入药物直达膀胱外底部位；
上述的注射通道输入孔设置有螺口；当螺口处安装体外连接器后能够作为施用物理方法的电极使用；
上述的通过特征个人腹腔构造三维数据虚拟骨盆环境模拟验证膀胱复位手术方案，具体方法是使用公知的虚拟现实技术，将多个VR虚拟三维眼睛和触感手术器具构建在虚拟手术台软件互动平台上，整合成手术模拟工程系统，手术操作人员通过手术模拟工程系统在虚拟现实环境内演习膀胱复位手术方案，直至得到最佳方法和效果。
2.根据权利要求1所述的骨盆腔内膀胱底外支架和植入方法，其特征是：上述的减压弧至耻骨梳上沿钩之间桥板断面中设置有注射通道；当注射通道作为药物缓释体时可以储蓄部分药液，药液随体温热胀时自动从输出孔渗出，当注射通道内外压相等后自动停止渗出。
3.根据权利要求1所述的骨盆腔内膀胱底外支架和植入方法，其特征是：上述的注射通道输入孔端设置有螺口；当螺口处安装连接器后可从体外注入药物直达膀胱外底部位；当螺口处安装体外连接器后能够作为施用物理方法的电极使用。
CN201610365490.4A 2016-05-30 2016-05-30 骨盆腔内膀胱底外支架和植入方法 Active CN105769380B (zh)

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