CN110584852A - 一种热穿刺支架置入器 - Google Patents
一种热穿刺支架置入器 Download PDFInfo
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Abstract
本发明提供一种热穿刺支架置入器,支架置入器具有近端和远端,前手柄远端设有外管,从近端向远端延伸,外管远端的外径小于或等于3.15mm,外管内设有绝缘中管,绝缘中管内设有导电部,绝缘中管和导电部从近端向远端延伸,导电部近端末端可与外部电源相连接,外管近端和所述绝缘中管之间设有助推管,助推管的远端与所述绝缘中管的近端相互连接,导电部的远端设有绝缘部,绝缘部上分布有导电头,导电头与导电部连接实现导电功能,同时导电部起到支撑支架作用支架压缩后位于导电部远端与外管之间的空间中。前手柄与外管近端相连接,沿助推管后撤前手柄,带动所述外管后撤释放支架。
Description
技术领域
本发明涉及一种医疗器械领域的热穿刺置入器,特别是涉及一种切割、注射功能为一体 的热穿刺支架置入器。
技术背景
消化道胆囊吻合术,就是在内镜下热置入器经胃壁或十二指肠壁穿刺进入到目标位置胆 囊内,将全覆膜双蘑菇头支架的远端放置在胆囊内,蘑菇头的近端放置在胃或十二指肠内, 以打通消化道和胆囊之间的通道,也就是重新造了一条消化道与胆囊之间的新路。再通过胃 镜和重新建成的通道,利用取石网篮将胆囊内的结石取出,从而实现内镜下保胆取石手术, 为不适宜手术的胆囊疾病病人提供了一种全新治疗问题,也能为胆囊功能良好的病人提供了 一种保留胆囊功能的治疗方法,提高患者远期生活质量。胃胰腺假性囊肿支架吻合手术,在 内镜下经胃穿刺进入患者胰腺假性囊肿内,放置一大口径全覆膜双蘑菇头支架,实现了胃与 胰腺假性囊肿的吻合,从而对胰腺假性囊肿内积液和坏死物进行充分引流。
十二指肠胆管吻合术,传统的ERCP手术,是通过ERCP内镜从十二指肠逆行将导丝等 器械插入十二指肠乳头到达胆总管,对胆总管进行取石活检治疗等。对于导丝难插入的病人, 通常要经皮穿刺或开展外科手术,可能降低患者生活质量或带来更大的创伤。
胃肠吻合术,受肿瘤侵犯,胃中食物进入肠道的通道被堵死后,呕吐不止的患者以往要 么接受开腹手术,建立胃肠新通道,要么只能靠静脉营养支持。而对于那些年纪偏大或者身 体状况已经不适合进行开腹手术患者来说,生存质量极低,也给家庭带来了沉重负担。胃肠 吻合术,就是在内镜下经胃穿刺进入到近端小肠内,放置一大口径全覆膜双蘑菇头支架,以 打通胃和小肠之间的通道,也就是重新造了一条胃与小肠之间的新路,从而解决十二指肠梗 阻给患者生活带来的影响。
以往这样的“旁路”建设需进行全麻开腹手术,创伤较大。而内镜下的微创手术创伤小, 手术时间短,痛苦小,恢复快,充分体现了内镜微创的优势。近年来,随着内镜技术以及各 种器械配件的不断发展和更新换代,内镜在消化系统各种疾病诊疗上发挥了愈来愈重要的作 用,特别是内镜下微创治疗手术的不断创新,为很多不能或不愿手术的胃肠道和胆胰疾病的 患者提供了新的微创治疗方法。目前以上四个传统手术,支架通常直径为φ10~φ16mm双蘑 菇头金属支架,配套的热置入器外径为φ3.5mm~φ3.6mm(10.5Fr~10.8Fr),传统的超声内镜 钳道φ3.7mm,因间隙过小,传统带电置入器在内镜钳道内来回运动很不自如,这是以上手 术开展困难的主要原因。同时超声内镜的外径φ14mm,比传统胃镜外径φ10mm大了4mm, 操作起来更不方便,能到达的地方也相对更少。
因此,为了实现通过胃镜开展胃胆吻合术,胃肠吻合术以及经人体自然腔道内镜手术 (NOTES)等,需要设计更小的带电置入器,通过胃镜钳道,简化支架释放步骤,以便更安 全更快捷的释放支架,本发明提供了一种全新的解决胆管梗阻的方式,同时节约了手术时间, 节约手术器械,降低手术难度,为更多医生开展此项手术提供了可能。
发明内容
本发明的热穿刺支架置入器,取消了传统的置入器内管和导电丝,由导电部件代替,既 起到支撑支架目的同时又具备传输高频电功能。可将现有的热穿刺置入器的外径由3.5mm~3.6mm(10.5Fr~10.8Fr)减小到3.15mm(9.5Fr),使热穿刺置入器能过通过传统的胃 镜钳道φ3.2mm,为医生做更前沿的消化道胆囊吻合术,十二指肠胆管吻合术,胃胰腺假性 囊肿支架吻合手术,胃肠吻合术以及NOTES手术等提供了可能。
以下,将导电头的一端定义为远端,将置入器外接通电的一端定义为近端。
热穿刺支架置入器具有近端和远端,前手柄远端设有外管,外管从近端向远端延伸,所 述外管远端的外径小于或等于3.15mm,所述外管内设有绝缘中管,从近端向远端延伸,所述 绝缘中管内设有导电部,绝缘中管和导电部从近端向远端延伸,所述导电部近端末端可与外 部电源相连接;所述外管近端和所述绝缘中管之间设有助推管,所述助推管的远端与所述绝 缘中管的近端相互连接;绝缘部位于所述导电部的远端,导电部的远端设有绝缘部,绝缘部 上分布有导电头,导电头与导电部连接实现导电功能,支架压缩后位于导电部远端与外管之 间的空间中,前手柄与外管近端相连接,沿助推管后撤前手柄,带动所述外管后撤释放支架。 导电部既起到导电作用,同时起到支撑支架作用,与传统支架植入器比较,减少了内管和导 丝,同时可以导电,对组织进行切割,到达病灶位置后释放支架。
绝缘部和导电部之间具有一定的间隙,在置入器的远端末端具有导电头,导电头的一端 可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙,从而与导电部连接实现导 电功能,导电头的另一端覆于绝缘部的外表面。
优选地,导电部为空心导电部。
更优选地,导电部的近端末端与鲁尔接头相连通实现注液。
优选地,导电部为导电丝。
优选地,导电部为镍钛丝
优选地,导电部为金属材料。更优选地,导电部为不锈钢材料。
优选地,绝缘部的材质为陶瓷。
外管包括近端外管和远端外管,所述近端外管和远端外管采用锥度连接。助推管向近端 延伸与后手柄相连接,所述前手柄和后手柄之间设有定位部。在距离所述导电头一定距离的 导电部的外表面上,覆有阻力部。导电头由两根或四根导电丝构成,两根或四根导电丝均匀 分布在绝缘部外表面的槽内。导电头靠近外侧的另一端完全覆于绝缘部的外表面,用所述导 电头进行切割时,伤口切割面是圆形面。导电部的外表面可以覆有铆接管,所述导电头的一 端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙,通过所述铆接管与所述 导电部连接实现导电功能。
有益效果:
本发明热穿刺支架的外径小于现有技术中的支架置入器的外径,为很多不能或不愿手术 的胃肠道和胆胰疾病的患者提供了新的微创治疗方法。
本发明的热穿刺置入器能将直径φ10mm~φ16mm双蘑菇头镍钛丝编织金属支架装入其 中,通过传统胃镜钳道3.2mm进入胃,十二指肠等器官,置入器通电穿刺胃壁或肠壁,进入 小肠,胆囊,胰腺囊肿,胆总管等结构内,进行支架精确释放,可以将以上组织分别与胃壁 或肠壁吻合,实现引流,保胆,取石,开通旁路等功能。
附图说明
图1A是置入器剖面示意图
图1B是置入器剖面远端结构示意图
图2是置入器产品整体示意图
图3A是当导电部为空心导电部时图1B的B-B剖面示意图
图3B是当导电部为空心导电部时图1B的C-C剖面示意图
图4A是当导电部为导电丝时图1B的B-B剖面示意图
图4B是当导电部为导电丝时图1B的C-C剖面示意图
图5A是与图3A和3B对应的支架置入器的近端尾部结构剖面图
图5B是5A的局部放大图
图6是与图4A和4B对应的支架置入器的近端尾部结构剖面图
图7A-7D是不同类型的置入器远端示意图
图8A-8B是一体式的置入器远端示意图
图9A-9B是分体式的置入器远端示意图
图10A-10C是翻边式的置入器远端示意图
图11是安全卡扣示意图
图12是双蘑菇支架完全打开示意图
11、导电头,12、绝缘部,13、导电部,21、外管,211、近端外管,212、远端外管, 22、助推管,23、绝缘中管,24、安全卡扣,25、外管紧锁帽,26、安全锁,27、定位部, 28、阻力部,29、铆接管,30、前手柄,31、后手柄,32、导电座,33、导电插头,34、鲁 尔接头,40、远端组织,41、近端组织,42、双蘑菇头支架
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发 明进行进一步详细说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于 限定本发明。
以下,将导电头的一端定义为远端,将支架置入器外接通电的一端定义为近端。
如图1A、1B和图2所示,本发明的支架置入器具有近端和远端,支架置入器包括外管 21,助推管22,绝缘中管23,外管紧锁帽25,安全锁26,定位部27,阻力部28,前手柄 30,后手柄31,导电座32,导电插头33,鲁尔接头34,导电头11,绝缘部12,导电部13。
外管21包括近端外管211和远端外管212,近端大外管211设置在前手柄30远端,可通过外管紧锁帽25与前手柄30固定,前手柄30近端设有安全锁26,安全锁26具有螺纹, 可与前手柄30近端螺纹匹配安装。外管21内设有绝缘中管23和支架,支架近端与绝缘中管 23的远端相互抵接,支架远端与绝缘部12靠近,留有一定的间隙,近端外管211与远端外 管212采用锥度连接,近端外管211和绝缘中管23之间设有助推管22,助推管22可以为不 锈钢材料,助推管22的远端与绝缘中管23的近端相互连接,近端外管211和远端外管212 的锥度设计,使得进入病灶部位的远端外管212的尺寸小于或等于3.15mm,而近端外管211 和绝缘中管23之间设有助推管22,从而提供释放支架所需的力。绝缘中管23可以由特殊高 分子材料聚醚醚酮制成,具有高性能的电绝缘型,可以将导电部13的高频电与助推管22绝 缘隔离,使操作者完全避免触电风险。助推管22向近端延伸与后手柄31相连接,在后手柄 31的近端设有导电座32,导电座32内具有导电插头33,导电插头33可以通过导电部13与 导电头11相连通,从而实现通电。
在前手柄30和后手柄31之间还可以设有定位部27,定位部27可以设计成安全卡扣24 的结构,如图11所示,定位部27为安全卡扣24结构,释放支架时,先旋松安全锁26,将 前手柄30向近端后撤,碰到安全卡扣24,支架远端在远端组织40内释放,回撤支架置入器, 将支架提拉靠近近端组织内,取下安全卡扣24,继续向近端后撤前手柄30,在近端组织41 内继续释放支架,从而实现支架将远端组织40和近端组织41吻合连接。
在距离导电头11一定距离的导电部13的外表面上,可覆有阻力部28,阻力部28在支 架释放时,可以给支架一定的阻力,使得支架不容易滑落到病灶外部。
支架置入器的远端还包括导电头11,绝缘部12,导电部13。当导电插头33外接高频电 源后,高频电源通过导电部13传送到导电头11处,使得支架置入器具有电切功能,对人体 组织进行高频切割。导电部13可以为任意种类的医用金属材料,比如镍钛材料或者不锈钢材 料;导电部13设于绝缘中管23内,从远端延伸到近端,通过后手柄31与导电插头33相连 接,可以根据实际需求设计导电部13的外径尺寸,本发明可以通过导电部13的设计将现有 的热穿刺支架置入器的置入部分的外径由3.5mm~3.6mm(10.5Fr~10.8Fr)减小到3.2mm(9Fr) 以下,优选地可以减小到3.15mm(9.5Fr)。另外,导电部13可以为空心导电部,从而实现 注液显影功能,导电部13也可以设计成导电丝。当导电部13设计成空心导电部时,图1B 的B-B位置处的剖视图如图3A所示,显示了导电部13,绝缘中管23和远端外管212的位置 关系,图1B的C-C位置处的剖视图如图3B所示,显示了导电部13,绝缘中管23和近端外 管212的位置关系;图5A是与图3A和3B对应的支架置入器的近端尾部结构剖面图,图5B是对于5A的局部放大图,导电座32内具有导电插头33,导电插头33可以通过导电部13与 导电头11相连通,从而实现通电;导电部13的近端与鲁尔接头34相连通,医生可以通过标 准注液器连接鲁尔接头34,并可以向空心管腔内注液或造影剂,液体造影剂通过导电部13 的管腔,到达置入器的远端导电头11处,进而注入病人病灶位置,造影剂在X射线下显影, 为医生标明病灶目标位置,医生可为下一步支架释放做好准备。
当导电部13设计成导电丝时,导电丝可以根据需求采用不同的尺寸。图1B的B-B位置 处的剖视图如图4A所示,显示了导电部13,绝缘中管23和远端外管212的位置关系,图1B的的C-C位置处的剖视图如图4B所示,显示了导电部13,绝缘中管23和近端外管212 的位置关系;图6是与图4A和4B对应的支架置入器的近端尾部结构剖面图,导电座32内 具有导电插头33,导电插头33可以通过导电部13与导电头11相连通,从而实现通电。
绝缘部12位于导电部13的远端,绝缘部12和导电部13之间具有一定的间隙,导电头 11的一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙,从而与导电部13 连接实现导电功能,导电头11的另一端覆于绝缘部12的外表面。高频电通过导电部13传输 到支架置入器的远端导电头11处,使支架置入器具有电切割功能,可以对人体组织进行高频 切割及穿刺,绝缘部12可以采用陶瓷等材料制成,可以防止组织黏粘,使切割更方便的进行。
本发明导电部13取代了传统支架置入器的内管和导电丝,具有导电功能,将原来内管外 径φ1.1mm和导电丝外径φ0.3mm,替换成直径小于φ0.4mm的导电部13,总直径减小了φ 1mm的空间(减小了3Fr的空间),使常规覆膜胃肠支架(10mm~16mm)可以装入,并且由 原来传统的热置入器外径φ3.5mm~φ3.6mm(10.5Fr~10.8Fr)减小到3.15mm(9.5Fr),使电 置入器能够顺利通过φ3.2mm胃镜钳道。
本发明的支架置入器远端的导电头11,绝缘部12和导电部13的结构可以如图7A-7D所 示,导电头11可以由两根或四根导电丝构成,其一端可以从远端向近端延伸进入绝缘部12 和导电部13之间的间隙,从而与导电部13连接实现导电功能,导电头11的另一端覆于绝缘 部12的外表面。导电头11还可以在远端以两根或者四根导电丝均匀分布在绝缘部12外表面 的槽内,实现导电切割功能。在绝缘部12的外表面槽内相邻导电丝间隔角度相同,在绝缘部 12的外表面上呈放射状的径向分布。
如图8A-8B所示,导电头11的一端可以从远端向近端延伸进入绝缘部12和导电部13 之间的间隙,从而与导电部13连接实现导电功能,导电头11的另一端完全覆于绝缘部12的 外表面。此时用导电头11进行切割时,切割面是圆形面,而不是一个直型切口,在利用止血 夹止血时更易止血,有利于伤口愈合。
如图9A-9B所示,导电部13的外表面可以覆有铆接管29,导电头11的一端可以从远端向近端延伸进入绝缘部12和导电部13之间的间隙,通过铆接管29与导电部13连接实现导电功能,铆接管29可采用不锈钢材质,能够将导电部13和绝缘部12连接。如图9A所示, 导电头11的另一端可以完全覆于绝缘部12的外表面,此时用导电头11进行切割时,切割面 是圆形面,而不是直型切口,有利于伤口愈合。
如图10A-10C所示,导电头11的另一端还可以一根导电丝的形式分布在绝缘部12表 面的槽内,并在支架置入器的远端末端绕圈,形成一字斜面导电切口,此时切割组织时,利 用的是绕圈的导电丝和分布在槽内的导电丝。若没有铆接管29,一端的导电头11和导电部 13直接相连,另一端导电头11在绝缘部12外周分布,也可实现导电功能。
本发明的支架植入器在使用时,在导电插头33外接高频电源后,高频电源通过导电部 13传送到导电头11处,使得支架置入器具有电切功能,可以对病变的远端组织40进行切割, 若是导电部13为空心导电部,外接鲁尔接头,使得支架置入器具有注液功能。
如图12所示,通过热穿刺支架置入器释放双蘑菇头支架42,当双蘑菇头支架42打开 后,一端在远端组织40内,另一端在近端组织41内。
上所述仅是本申请的优选实施方式,使本领域技术人员能够理解或实现本申请的发明。 对于这些实施例的多种修改及组合对于本领域的技术人员来说将是显而易见的,本文中所定 义的一般原理可以在不脱离本申请的精神或范围的情况下,在其他实施例中实现。因此,本 申请将不会被限制在本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相 一致的最宽的范围。
Claims (15)
1.一种热穿刺支架置入器,其特征在于,所述热穿刺支架置入器具有近端和远端,前手柄远端设有外管,所述外管从近端向远端延伸,所述外管远端的外径小于或等于3.15mm,所述外管内设有绝缘中管,所述绝缘中管从近端向远端延伸,绝缘中管内设有导电部,所述导电部从近端向远端延伸,所述导电部近端末端可与外部电源相连接;所述外管近端和所述绝缘中管之间设有助推管,所述助推管的远端与绝缘中管的近端相互连接;所述绝缘部位于所述导电部的远端,所述导电部的远端设有绝缘部,绝缘部上分布有导电头,所述导电头与导电部连接实现导电功能,导电部同时起到支撑支架作用,支架压缩后位于导电部远端与外管之间的空间中,前手柄与外管近端相连接,沿助推管后撤前手柄,带动所述外管后撤释放支架。
2.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述绝缘部和所述导电部之间具有一定的间隙,在置入器的远端末端具有导电头,所述导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙,从而与导电部连接实现导电功能,所述导电头的另一端覆于绝缘部的外表面。
3.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电部为空心管状导电部。
4.根据权利要求3所述的热穿刺支架置入器,其特征在于,所述导电部的近端末端与鲁尔接头相连通实现注液。
5.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电部为导电丝。
6.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电部为镍钛丝。
7.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电部为金属材料。
8.根据权利要求7所述的热穿刺支架置入器,其特征在于,所述导电部为不锈钢材料。
9.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述外管包括近端外管和远端外管,所述近端外管和远端外管采用锥度连接。
10.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述助推管向近端延伸与后手柄相连接,所述前手柄和后手柄之间设有定位部。
11.根据权利要求1所述的热穿刺支架置入器,其特征在于,在距离所述导电头一定距离的导电部的外表面上,覆有阻力部。
12.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电头由两根或四根导电丝构成,两根或四根导电丝均匀分布在绝缘部外表面的槽内。
13.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电头靠近外侧的另一端完全覆于绝缘部的外表面,用所述导电头进行切割时,伤口切割面是圆形面。
14.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述导电部的外表面可以覆有铆接管,所述导电头的一端可以从远端向近端延伸进入所述绝缘部和所述导电部之间的间隙,通过所述铆接管与所述导电部连接实现导电功能。
15.根据权利要求1所述的热穿刺支架置入器,其特征在于,所述绝缘部的材质为陶瓷。
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PCT/CN2018/099489 WO2019237481A1 (zh) | 2018-06-13 | 2018-08-09 | 一种热穿刺支架置入器 |
EP18922575.8A EP3808316A4 (en) | 2018-06-13 | 2018-08-09 | HOT PERFORATION ENDOPROTHESIS IMPLANTATION DEVICE |
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US20210100668A1 (en) | 2021-04-08 |
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