CN107928842A - 植入式记忆勃起支架 - Google Patents
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Abstract
本发明涉及一种植入式记忆勃起支架，包括两片对应抱合阴茎的弧形支撑骨架，所述支撑骨架为丝状或条状的热效应记忆合金编织组成的片状网体；片状网体外部包覆有生物涂层，所述片状网体中对应任意一处记忆合金交会处的涂层厚度向交会点逐渐增大；本发明结构简单，手术操作难度小，植入成功率高；硅胶、记忆合金等材料生物相容性好，无毒副作用，风险极低，成本低廉。
Description
技术领域
本发明涉及一种医疗领域性辅助器械，具体涉及一种植入式记忆勃起支架。
背景技术
男性性功能障碍包括性欲减退、勃起功能障碍、性高潮和射精功能障碍、阴茎疲软功能障碍，其中勃起功能障碍是最常见的男性性功能障碍。勃起功能障碍(Erectiledysfunction,简称 ED)， ED是指在过去3月内阴茎不能勃起或阴茎勃起硬度不足于插入阴道，或阴茎勃起硬度维持时间不足于完成满意的性生活的病理现象。随着社会发展，男性生活压力日益增大，对生理健康影响较大，目前40岁以上男性，ED发病率高达46%左右。目前世界技术对ED治疗方法根据机理措施分为三种：以性知识教育心理治疗、口服药物、真空负压缩窄装置(VCD)为一线治疗方法，尿道药物治疗及阴茎海绵内药物注射(ICI)为二线治疗方法，阴茎假体植入则为三线治疗方法。
常用的ED一线、二线治疗方法如口服药物、阴茎海绵体注射疗法，真空负压装置疗法为非手术疗法，都是作为一次性人工诱发勃起而完成的方法，有效率低，具有不同程度的副作用，效果不佳。且对于器质性阳痿如外伤、盆腔手术伤及阴部神经、血管损伤丧失勃起功能者以及少数顽固性功能性ED患者经服药治疗无效无法达到治疗需求。为解决以上问题，医学界推出了第三线疗法——阴茎假体植入，假体植入疗法在国外很常见的植入方式为俗称三件套的人工勃起装置的植入手术疗法，如专利200480028569.3中提到的植入阴茎假体，机理为将患者阴茎两侧海绵体取出，植入两个圆管；然后将一个泵阀安放在阴囊当中，另有一个比较大的储液囊安置在盆腔当中，里面充满盐溶液。当需要进行性生活的时候用手挤压阴囊当中的泵将储液囊当中的盐溶液抽到阴茎当中的两个圆管当中，这样阴茎就会勃起；当结束性生活的时候同样可以使用阴囊当中的泵将盐溶液抽离圆管腔体返回储液囊，随着圆管内的液体排出，圆管收缩阴茎随之疲软回到自然状态。但这种植入式人工勃起装置风险较大，手术复杂，操作繁琐，植入人体后隔离组织正常连接，破坏了阴茎海绵体血液供应，对患者本身生理组织造成损伤。使用过程中有可能漏液，有感染风险，易脱落，可靠性很低，并且手术费用较高。
另如专利CN01127773及CN01127621.5中提到的外用型辅助装置，主要针对人群为勃而不坚的男性患者，该发明装置骨架的连接方式没有考虑到记忆材料自身收缩变形的局限性，仅仅靠记忆材料内部的形变很难达到使用要求。从医学角度来讲，勃起硬度不足于插入阴道的阴茎体本身硬度较低，表皮组织未能被海绵体充血膨大，该发明装置很难松紧适中的包覆于阴茎体上，导致该装置在性交过程中会发生与阴茎体表面产生反复性的相互运动，易损伤组织、增加不适感，更有甚者有脱落掉入阴道的情况发生。
发明内容
为了解决上述问题，提供一种满足性交需要、安全性能高、体验舒适、不易脱落的勃起辅助支架，本发明设计了一种新型植入式记忆勃起支架。
本发明的具体技术方案为：一种植入式记忆勃起支架，包括两片对应抱合阴茎的弧形支撑骨架，所述支撑骨架为丝状或者条状记忆合金编织组成的片状网体；片状网体外部包覆有涂层，所述片状网体中对应任意一处记忆合金交会处的涂层厚度向交会点逐渐增大。
作为优选地，所述记忆合金为镍钛合金；所述涂层为硅胶层或柔性高分子层或柔性生物材料层。
作为优选地，所述片状网体为对应阴茎外径的弧形网体；所述片状网体所对应的圆弧角度为90度左右，植入后对应抱合阴茎体；所述片状网体两端为沿其长度方向凸出的弧形侧沿。
更进一步地，记忆合金直径为0.5-1.5mm。记忆合金为波浪形丝状或者条状物。
将两片支撑骨架植入白膜与阴茎筋膜之间，片状网体前端到阴茎龟头，后端止于阴茎脚处，使两片状网体对应抱合在阴茎两侧。
记忆合金1常规状态下温度为T1，T1温度时记忆合金1为支撑阴茎保持自然状态的低温相形状；记忆合金1热源热敷后达到温度T2，T1温度时记忆合金1为支撑阴茎保持勃起状态的高温相形状，其中T1的温度值约为34-36°C，T2的温度值约为37°C。
有益技术效果：结构简单，以编织成弧形片状网体的记忆合金作为支撑骨架，片状网体表层包覆有硅胶，附着硅胶后支撑骨架仍旧保持网状孔隙结构，植入人体后，有助于组织生长融合，使片状网体与人体组织生长成一体，防止支架在阴茎内发生位移，帮助阴茎组织保持良好的弹性和刚性，使患者使用感受更接近真实的生理组织。
本发明结构简单，手术操作难度小，植入成功率高；硅胶、记忆合金等材料生物相容性好，无毒副作用，风险极低，成本低廉。
附图说明
图1为本装置结构简图；
图2为支撑骨架结构简图；
图3为记忆合金截面图；
图4为记忆合金交会处结构结构简图。
图中1为记忆合金、2为涂层。
具体实施方式
实施例一 一种植入式记忆勃起支架，参见图1-3：包括两片对应抱合阴茎的弧形支撑骨架，所述支撑骨架为丝状或者条状记忆合金1编织组成的片状网体；片状网体外部包覆有涂层2，所述片状网体中对应任意一处记忆合金1交会处的涂层2厚度向交会点逐渐增大。
将一组支撑骨架植入白膜与阴茎筋膜之间，与海绵体贴合，支架前端到阴茎龟头，后端止于阴茎脚处，使两片支架对应抱合在阴茎海绵体的两侧。
结构简单，以编织成弧形片状网体的记忆合金1作为支撑骨架，片状网体表层包覆有硅胶，附着硅胶后支撑骨架仍旧保持网状孔隙结构，植入人体后，有助于阴茎组织相容，使片状网体与人体组织生长成一体，收缩的时候带动海绵体一起收缩，使患者使用感受更接近真实的生理组织。
本发明利用阴茎在阴道内及在体外的温度差来控制支架的收缩，选取合适的记忆材料的高温相低温相变化区间。使用时只需要用热毛巾等热源热敷阴茎使阴茎温度升高到记忆合金1记忆的膨胀温度条件，支架就可以逐渐变化到记忆的高温相形状，此时阴茎通过支撑骨架膨大勃起；性交过程中，由于阴道内部温度较高，支撑骨架一直保持高温相形状，使阴茎一直处于高温勃起状态；性生活结束后，阴茎抽出阴道自然冷却至人体自然状态下阴茎的温度，记忆合金1恢复常温形态即低温相形状，阴茎逐渐收缩变小。
设置硅胶作为涂层2，附着在记忆合金1表面使其软硬度适中，极大程度的保证了本装置的舒适性。
所述片状网体中对应任意一处记忆合金1交会处的涂层2厚度向交会点逐渐增大。避免记忆合金1交会处的在支撑骨架随温度变化过程中对阴茎组织产生挤压，提高本产品的使用舒适度。
实施例二 本实施例与上述实施例基本相同，不同之处在于，所述记忆合金1为镍钛合金；所述涂层2为硅胶层或柔性高分子层或柔性生物材料层。该装置结构由记忆材料热弹性马氏体如镍钛合金作为骨架，镍钛合金记忆效应优良、性能稳定、生物相容性好。
实施例三 本实施例与上述实施例基本相同，不同之处在于，记忆合金1为波浪形丝状或者条状物，记忆合金1直径为0.5-1.5mm。有效增加本产品植入的稳定性，避免片状网体在阴茎内进行移动。
实施例四 本实施例与上述实施例基本相同，不同之处在于，所述片状网体为对应阴茎外径的弧形网体；所述片状网体所对应的圆弧角度为90度；所述片状网体两端为沿其长度方向凸出的弧形侧沿。
片状网体直径及长度分为大、中、小三个型号以适用于不同人体阴茎尺寸。设置片状网体所对应角度为90度，通过两片片状网体抱合阴茎，在不影响本产品勃起辅助的同时，尽可能减少植入体大小，减少人体创伤，提高患者体验舒适度。
记忆合金1利用阴茎在体外温度T1低的自然状态为低温相形状，利用热源热敷后达到温度T2，支架伸展带动阴茎勃起以及性交过程中的持续勃起的状态为高温相形状，其中T1的温度值约为34-36°C，T2的温度值约为37°C。
Claims (9)
1.一种植入式记忆勃起支架，包括两片对应抱合阴茎的弧形支撑骨架，其特征是：所述支撑骨架为丝状或者条状热效应记忆合金（1）编织组成的片状网体；片状网体外部包覆有涂层（2），所述片状网体中对应任意一处记忆合金（1）交会处的涂层（2）厚度向交会点逐渐增大。
2.根据权利要求1所述的植入式记忆勃起支架，其特征是：所述记忆合金（1）为镍钛合金。
3.根据权利要求1所述的植入式记忆勃起支架，其特征是：所述涂层（2）为硅胶层或柔性高分子层或柔性生物材料层。
4.根据权利要求1所述的植入式记忆勃起支架，其特征是：所述片状网体为对应阴茎外径的弧形网体。
5.根据权利要求4所述的植入式记忆勃起支架，其特征是：所述片状网体所对应的圆弧角度为90度。
6.根据权利要求5所述的植入式记忆勃起支架，其特征是：所述片状网体两端为沿其长度方向凸出的弧形侧沿。
7.根据权利要求1-6任意一项所述的植入式记忆勃起支架，其特征是：记忆合金（1）为波浪形丝状或者条状物。
8.根据权利要求7所述的植入式记忆勃起支架，其特征是：记忆合金（1）直径为0.5-1.5mm。
9.根据权利要求8所述的植入式记忆勃起支架，其特征是：记忆合金（1）常规状态下温度为T1，T1温度时记忆合金（1）为支撑阴茎保持自然状态的低温相形状；记忆合金（1）热源热敷后达到温度T2，T1温度时记忆合金（1）为支撑阴茎保持勃起状态的高温相形状，其中T1的温度值约为34-36°C，T2的温度值约为37°C。
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| CN1328809A (zh) * | 2001-07-13 | 2002-01-02 | 周星 | 柔而刚性辅助器 |
| US20130131443A1 (en) * | 2011-11-21 | 2013-05-23 | Northwestern University | Penile prosthesis |
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| CN1328809A (zh) * | 2001-07-13 | 2002-01-02 | 周星 | 柔而刚性辅助器 |
| US20130131443A1 (en) * | 2011-11-21 | 2013-05-23 | Northwestern University | Penile prosthesis |
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| CN113648126A (zh) * | 2021-08-17 | 2021-11-16 | 上海交通大学医学院附属第九人民医院 | 一种温敏支架 |
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