CN111743619A - 一种扩张切开装置 - Google Patents

一种扩张切开装置 Download PDF

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CN111743619A
CN111743619A CN202010781206.8A CN202010781206A CN111743619A CN 111743619 A CN111743619 A CN 111743619A CN 202010781206 A CN202010781206 A CN 202010781206A CN 111743619 A CN111743619 A CN 111743619A
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incision
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knife
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黄永辉
闫秀娥
常虹
张耀朋
王迎春
郑炜
刘文正
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Peking University Third Hospital Peking University Third Clinical Medical College
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Abstract

本发明公开了一种扩张切开装置，涉及手术工具，包括外壳体、扩张元件和切开组件，扩张元件设于外壳体一端，并与外壳体内部连通，扩张元件用于钻入并扩张胆胰管的狭窄段及消化道管腔之间的穿刺路径，外壳体的侧壁设有滑槽，滑槽连通外壳体内腔与外界，切开组件包括切开刀和滑柄，切开刀设于外壳体内，滑柄套设于外壳体外周，扩张元件的一端设有连通孔，连通孔连通扩张元件内腔与外界，滑柄能够带动切开刀在外壳体的延伸方向往复移动，并使切开刀通过连通孔伸出外壳体，该扩张切开装置能够顺利通过胆胰管的严重狭窄段，对严重狭窄段进行扩张，并能够用于扩张消化道管腔之间的穿刺路径。

Description

一种扩张切开装置
技术领域
本发明涉及手术工具，具体是涉及一种扩张切开装置。
背景技术
内镜下逆行胰胆管造影术(ERCP)和超声内镜(EUS)是近年来发展最快，新技术出现最多的两项技术。目前胆胰系统的绝大多数良性疾病和部分恶性疾病均可以通过以上两项技术及其衍生技术达到诊断和治疗的目的，众多患者从中获益。
ERCP主要是通过十二指肠镜的治疗性钳道，插入针对不同疾病的不同附件，从而达到诊断和治疗的目的。但有部分疾病通过现有附件无法达到治疗目的，例如部分胆胰管狭窄性疾病，无论是胆胰管的良性还是恶性狭窄，均通过如下步骤进行诊断和治疗：(1)十二指肠镜进镜至乳头，通过钳道送入乳头切开刀和导丝，然后在导丝引导下选择性胆管和/或胰管插管；(2)在导丝成功进入胆管和胰管系统后，进行胆胰管内注射造影剂，明确狭窄部位和程度；(3)若怀疑胆管恶性狭窄则需要在狭窄段进行活检以取得病理学证据，胰管由于其特殊的生理结构，活检后易造成胰管损伤，出现急性胰腺炎等严重并发症，而且胰管的恶性狭窄通常从术前的影像学即可明确诊断，因此胰管一般不做活检；(4)若狭窄特别严重，直径小于4.4Fr(即乳头切开刀无法在导丝引导下通过狭窄段)，或者即使乳头切开刀能勉强通过狭窄段，但无法进行扩张以满足下一步支架置入的要求，则需要进一步对狭窄段进行扩张治疗。现有的扩张方式包括逐级扩张器(包括Sohendra逐级扩张探条和Sohendra支架回收器)和逐级扩张球囊。但在临床上有一部分病人由于狭窄非常严重，尤其是良性狭窄，通过以上两种方式均无法顺利通过狭窄段，更无法对狭窄段进行扩张，那么此部分病人后续只能选择手术，在一些有条件的医院进行EUS引导下的介入治疗。
EUS目前在临床上主要是三方面的作用：(1)通过超声影像诊断疾病；(2)通过EUS的钳道插入穿刺针对组织进行细针穿刺活检或抽吸，获取组织后从病理上诊断疾病；(3)通过EUS引导下进行一系列的介入治疗(主要包括：EUS引导下假性囊肿引流术，EUS引导下胆管引流术，EUS引导下胰管引流术，EUS引导下胆囊穿刺引流术，EUS引导下胃肠吻合术)。在EUS引导下的介入治疗中，需要以下步骤：(1)EUS选择适合的穿刺点；(2)EUS引导下将穿刺针经胃或经十二指肠穿刺入目标器官或病变(胆管，胰管，胆囊，假性囊肿或空肠)；(3)将导丝留置于目标器官或病变后，在导丝引导下应用Sohendra扩张器对穿刺通道进行扩张，或者单纯应用切开刀对穿刺路径进行通电切开，以便于进一步通过穿刺通道置入引流管或支架；(4)扩张穿刺通道后在X线和超声内镜引导下置入引流管和支架。上述第(3)步的实施对于后续能否成功治疗至关重要，但有些患者其穿刺路径上纤维瘢痕形成明显，从而使得扩张器无法顺利进入穿刺通道，并且在穿刺路径上有丰富的小血管，单纯应用切开装置则可能会出现无法挽救的大出血，无法达到安全扩张的目的。
发明内容
本发明的目的是提供一种扩张切开装置，以解决上述现有技术存在的问题，使得该扩张切开装置能够顺利通过胆胰管的严重狭窄段，对严重狭窄段进行扩张，并能够扩张消化道管腔之间的穿刺路径
为实现上述目的，本发明提供了如下方案：
本发明提供了一种扩张切开装置，包括外壳体、扩张元件和切开组件，所述扩张元件设于所述外壳体一端，并与所述外壳体内部连通，所述扩张元件用于钻入并扩张胆胰管的狭窄段及消化道管腔之间的穿刺路径，所述外壳体的侧壁设有滑槽，所述滑槽连通所述外壳体内腔与外界，所述切开组件包括切开刀和滑柄，所述切开刀设于所述外壳体内，所述滑柄套设于所述外壳体外周，所述扩张元件的一端设有连通孔，所述连通孔连通所述扩张元件内腔与外界，所述滑柄能够带动所述切开刀在所述外壳体的延伸方向往复移动，并使所述切开刀通过所述连通孔伸出所述外壳体。
优选地，所述外壳体为圆管体，所述扩张元件为圆锥形，且所述扩张元件的大端与所述外壳体固定连接，所述扩张元件外周设有螺纹。
优选地，所述扩张元件长度为2-3cm。
优选地，所述滑柄上设有电插头，所述电插头的一端用于与外部供电装置电连接，所述电插头的另一端与所述切开刀固定连接并用于对所述切开刀通电，所述切开刀为针形切开刀。
优选地，所述滑柄包括两个圆环和一个连接段，所述连接段套设于所述外壳体外周，两个所述圆环分别固定在所述连接段的两端，且两个所述圆环的排列方向与所述切开刀长度方向垂直。
优选地，所述外壳体上远离所述扩张元件的一端设有手柄，所述手柄为环状，用于操作者手持。
优选地，所述外壳体外周设有刻度，用于供操作者观察所述切开刀伸出所述连通孔的长度。
优选地，所述外壳体上靠近所述扩张元件的一端固定设有限位元件，所述限位元件套设于所述外壳体的外周，用于对所述滑柄限位，防止所述滑柄从所述扩张元件脱落或移位。
本发明相对于现有技术取得了以下技术效果：
本发明提供的扩张切开装置，包括外壳体、扩张元件和切开组件，扩张元件设于外壳体一端，并与外壳体内部连通，扩张元件用于钻入并扩张胆胰管的狭窄段及消化道管腔之间的穿刺路径，以便后序手术装置的导入，外壳体的侧壁设有滑槽，滑槽连通外壳体内腔与外界，切开组件包括切开刀和滑柄，切开刀设于外壳体内，从而在不需要切开时，将切开刀收纳于滑槽内，滑柄套设于外壳体外周，方便直接对滑柄进行施力，扩张元件的一端设有连通孔，连通孔连通扩张元件内腔与外界，并用于切开刀的伸入与伸出，滑柄能够带动切开刀在外壳体的延伸方向往复移动，并使切开刀通过连通孔伸出外壳体，普通狭窄直接通过扩张元件采用机械扩张，相对安全，当严重狭窄，无法通过扩张元件直接通过狭窄段并扩张时，通过将滑柄向靠近扩张元件的方向移动，带动切开刀向靠近连通孔的方向移动，直至切开刀的尖端通过连通孔伸出，控制切开刀对狭窄段进行微切开，切割完成后通过移动滑柄对切开刀收回，并通过扩张元件进行扩张，实现严重狭窄段或穿刺路径的扩张，并且，扩张元件内部能够通过导丝，使用导丝引导狭窄段的扩张与切开，安全可靠。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本发明提供的扩张切开装置位于扩张状态的主视图；
图2是图1中扩张切开装置的仰视图；
图3是本发明提供的扩张切开装置位于切开状态的主视图；
图4是图3中扩张切开装置的仰视图；
图中：1-外壳体，11-滑槽，2-扩张元件，31-圆环，32-连接段，4-电插头，5-切开刀，6-限位元件，7-手柄。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的目的是提供一种扩张切开装置，以解决现有用于扩张的附件无法通过胆胰管的严重狭窄段，更无法对严重狭窄段和消化道管腔穿刺路径进行扩张的技术问题。
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图和具体实施方式对本发明作进一步详细的说明。
如图1-图4所示，本发明提供一种扩张切开装置，包括外壳体1、扩张元件2和切开组件，扩张元件2设于外壳体1一端，并与外壳体1内部连通，扩张元件2用于钻入并扩张胆胰管的狭窄段，或者是消化道管腔之间的穿刺路径，以便后序手术装置的导入，外壳体1的侧壁设有滑槽11，滑槽11连通外壳体1内腔与外界，切开组件包括切开刀5和滑柄，切开刀5设于外壳体1内，从而在不需要切开时，将切开刀5收纳于滑槽11内，滑柄套设于外壳体1外周，方便直接对滑柄进行施力，扩张元件2的一端设有连通孔，连通孔连通扩张元件2内腔与外界，并用于切开刀5的伸入与伸出，滑柄能够带动切开刀5在外壳体1的延伸方向往复移动，并使切开刀5通过连通孔伸出外壳体1，普通狭窄直接通过扩张元件2采用机械扩张，相对安全，机械扩张时该扩张切开装置位于扩张状态(图1-图2)，当严重狭窄，无法通过扩张元件2直接通过狭窄段并扩张时，通过将滑柄向靠近扩张元件2的方向移动，带动切开刀5向靠近连通孔的方向移动，直至切开刀5的尖端通过连通孔伸出，此时该扩张切开装置位于切开状态(图3-图4)，控制切开刀5对狭窄段进行微切开，切割完成后通过移动滑柄对切开刀5收回，并通过扩张元件2进行扩张，实现严重狭窄段或穿刺路径的扩张，并且，扩张元件内部能够通过导丝，使用导丝引导狭窄段的扩张与切开，安全可靠。
具体地，外壳体1为圆管体，扩张元件2为圆锥形，且扩张元件2的大端与外壳体1固定连接，能够使得扩张元件2的尖端先通过狭窄段(或穿刺路径)，逐级扩张，保护患者，扩张元件2外周设有螺纹，在实际扩张过程中，通过旋转外壳体1，带动扩张元件2螺旋式钻入扩张，减小扩张阻力。
扩张元件2长度为2-3cm，扩张元件与外壳体连接处的直径为7Fr或8.5Fr，且扩张元件在与外壳体连接处外周设有一道不透X线涂层标记，宽度为2mm，扩张状态下，该扩张切开装置的长度为200cm，但上述尺寸只是一具体实施例，在实际生产过程中，本发明提供的扩张切开装置的尺寸均不限于上述限定，本领域技术人员可根据实际扩张需要对各个尺寸作适应性更改。
滑柄上设有电插头4，电插头4的一端用于与外部供电装置电连接，电插头4的另一端与切开刀5固定连接并用于对切开刀5通电，当切开刀5移动到位，可通过电插头4外接外部供电装置实现电路的连通，采用高频电流切割，安全可靠，切开刀5为针形切开刀5，能够实现微切开，减少对患者的损伤。
滑柄包括两个圆环31和一个连接段32，连接段32套设于外壳体1外周，能够沿外壳体1的外周往复滑动，两个圆环31分别固定在连接段32的两端，且两个圆环31的排列方向与切开刀5长度方向垂直，便于操作者手持，使用时直接通过手指穿过圆环31进行施力即可，方便握持。
外壳体1上远离扩张元件2的一端设有手柄7，手柄7为环状，用于操作者手持，在对扩张元件2进行螺旋式钻入时，直接通过手指作用于手柄7，通过手柄7带动外壳体1旋转，进而带动扩张元件2旋转即可，方便操作，更优的，手柄上设有导丝孔，导丝孔能够连通手柄内部、外壳体内腔和扩张元件内部，使得导丝能够顺利通过该扩张切开装置。
外壳体1外周设有刻度，用于供操作者观察切开刀5伸出连通孔的长度，当滑柄带动切开刀5移动时，滑柄移动至任意位置均能对应指向一刻度值，保证切开刀5的任意伸出长度均可读，且保证准确性，从而根据滑柄所在位置的刻度，换算出切开刀5伸出连通孔的长度，能够有效控制出针长度，安全可靠，更优的，外壳体上的刻度也可直接与切开刀8伸出长度对应，即滑柄所在位置的刻度即切开刀9伸出长度，读数更加直观方便。
外壳体1上靠近扩张元件2的一端固定设有限位元件6，限位元件6套设于外壳体1的外周，用于对滑柄限位，防止滑柄从扩张元件2脱落或移位，同时还能够判断出针到位，避免人为控制下针形刀出针长度的不稳定。
本说明书中应用了具体个例对本发明的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本发明的方法及其核心思想；同时，对于本领域的一般技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处。综上所述，本说明书内容不应理解为对本发明的限制。

Claims (8)

1.一种扩张切开装置，其特征在于：包括外壳体、扩张元件和切开组件，所述扩张元件设于所述外壳体一端，并与所述外壳体内部连通，所述扩张元件用于钻入并扩张胆胰管的狭窄段及消化道管腔之间的穿刺路径，所述外壳体的侧壁设有滑槽，所述滑槽连通所述外壳体内腔与外界，所述切开组件包括切开刀和滑柄，所述切开刀设于所述外壳体内，所述滑柄套设于所述外壳体外周，所述扩张元件的一端设有连通孔，所述连通孔连通所述扩张元件内腔与外界，所述滑柄能够带动所述切开刀在所述外壳体的延伸方向往复移动，并使所述切开刀通过所述连通孔伸出所述外壳体。
2.根据权利要求1所述的扩张切开装置，其特征在于：所述外壳体为圆管体，所述扩张元件为圆锥形，且所述扩张元件的大端与所述外壳体固定连接，所述扩张元件外周设有螺纹。
3.根据权利要求2所述的扩张切开装置，其特征在于：所述扩张元件长度为2-3cm。
4.根据权利要求1所述的扩张切开装置，其特征在于：所述滑柄上设有电插头，所述电插头的一端用于与外部供电装置电连接，所述电插头的另一端与所述切开刀固定连接并用于对所述切开刀通电，所述切开刀为针形切开刀。
5.根据权利要求1所述的扩张切开装置，其特征在于：所述滑柄包括两个圆环和一个连接段，所述连接段套设于所述外壳体外周，两个所述圆环分别固定在所述连接段的两端，且两个所述圆环的排列方向与所述切开刀长度方向垂直。
6.根据权利要求1所述的扩张切开装置，其特征在于：所述外壳体上远离所述扩张元件的一端设有手柄，所述手柄为环状，用于操作者手持。
7.根据权利要求1所述的扩张切开装置，其特征在于：所述外壳体外周设有刻度，用于供操作者观察所述切开刀伸出所述连通孔的长度。
8.根据权利要求1所述的扩张切开装置，其特征在于：所述外壳体上靠近所述扩张元件的一端固定设有限位元件，所述限位元件套设于所述外壳体的外周，用于对所述滑柄限位，防止所述滑柄从所述扩张元件脱落或移位。
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