CN113842201A - 一种带有冷冻功能的分体式外套管消融探针及方法 - Google Patents

一种带有冷冻功能的分体式外套管消融探针及方法 Download PDF

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CN113842201A
CN113842201A CN202010593103.9A CN202010593103A CN113842201A CN 113842201 A CN113842201 A CN 113842201A CN 202010593103 A CN202010593103 A CN 202010593103A CN 113842201 A CN113842201 A CN 113842201A
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split
probe
outer sleeve
ablation
ablation probe
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赵国江
岳宏雷
宋子豪
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Medinas Tianjin Technology Co ltd
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Tianjin Meidian Medical Technology Co ltd
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Priority to CN202010593103.9A priority Critical patent/CN113842201A/zh
Priority to US18/012,759 priority patent/US20230248410A1/en
Priority to PCT/CN2021/102524 priority patent/WO2021259379A1/zh
Priority to EP21829949.3A priority patent/EP4166105A4/en
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Abstract

本发明提供一种带有冷冻功能的分体式外套管消融探针及方法,包括内探针、外套管和手柄部分,所述内探针与所述外套管滑动连接,所述内探针的一端与所述手柄部分的一端固定,还包括拆分组件,所述拆分组件包括第一分体构件和第二分体构件,所述第一分体构件与所述第二分体构件可分离连接,所述第一分体构件与所述外套管固定,所述第二分体构件与所述手柄部分固定,所述外套管是绝热管。本发明具有的优点和积极效果是:外套管在内探针表面的滑动,可以改变内探针消融区域大小和分布;分体结构可以通过外套管形成体外与治疗靶区的通道,用于活检、给药和止血;分体结构可设计成不可复用结构,一次性使用提升消融探针的使用安全。

Description

一种带有冷冻功能的分体式外套管消融探针及方法
技术领域
本发明涉及一种消融探针,尤其是一种带有冷冻功能的分体式外套管消融探针。
背景技术
组织和肿瘤消融技术是近年来兴起的物理治疗方法,具有安全有效、微创和疗效确切的优点,广泛应用于多种组织和肿瘤的局部消融治疗。消融探针的设计和应用是该技术的核心之一,决定了其消融能力、微创性能、安全性和有效性。
在冷冻消融治疗进行前需要对消融靶区进行定位穿刺,有时也需要活检及对靶区注入药剂。一般需要采用辅助器具,比如扩张鞘,但扩张鞘增加手术成本、使用中不方便且会大幅度增大手术伤口,对于肿瘤消融手术有很多不良效果。消融探针往往需要一个隔热或绝缘结构,该结构一般设置在探针的内部,该内部设置的结构会使消融探针的直径增加,也阻碍冰球的形成,影响冷冻消融效果。
发明内容
本发明要解决的问题是提出一种带有分体式外套管的消融探针,以解决内探针消融区域大小和分布无法调控,及需要用到多种器具才能完成对靶区的扩张、用药、穿刺活检和消融的问题。
为解决上述技术问题,本发明采用的技术方案是:一种带有冷冻功能的分体式外套管消融探针,包括内探针、外套管和手柄部分,所述内探针与所述外套管滑动连接,所述内探针的一端与所述手柄部分的一端固定,包括拆分组件,所述拆分组件包括第一分体构件和第二分体构件,所述第一分体构件与所述第二分体构件可分离连接,所述第一分体构件与所述外套管固定,所述第二分体构件与所述手柄部分固定;所述外套管是绝热管;所述内探针是不设有绝热结构的冷冻消融探针或电冷消融探针。
进一步的,所述内探针是冷冻消融探针或电冷消融探针。
进一步的,所述绝热管设有电绝缘层。
进一步的,所述外套管的远端设有至少一个电极,电极以外部分为绝缘结构。
进一步的,所述内探针的表面设有刻度。
进一步的,所述消融探针还包括外鞘,所述外鞘的一端与所述第一分体构件固定,所述外鞘上设有通槽,所述外鞘还包括滑钮,所述滑钮穿过所述通槽与所述外套管固定。
进一步的,所述外鞘上设有刻度和限位槽。
进一步的,所述第一分体构件和所述第二分体构件的可分离连接结构为可复用分离结构或。
进一步的,所述可复用分离结构为卡接结构、旋接结构或过盈配合结构。
进一步的,所述第一分体构件和所述第二分体构件的可分离连接结构为不可复用分离结构。
进一步的,所述不可复用分离结构为扭断式结构、压断式结构或拉断式结构。
一种利用带有冷冻功能的分体式外套管消融探针的消融方法,将消融探针置入靶区,将第一分体构件和第二分体构件分离并抽出内探针使外套管与靶区形成通道,向外套管内注入药剂或通过外套管进行穿刺活检,将内探针置入外套管并将第一分体构件和第二分体构件连接或将内探针置入外套管后调整内探针与外套管的相应位置以调整消融区,启动消融探针对靶区进行消融。
进一步的,完成消融后将分离第一分体构件和第二分体构件并抽离内探针,向外套管再次注入药剂。
本发明具有的优点和积极效果是:
(1)通过分体结构的可以通过外套管形成外界与靶区的通道,可以对靶区输入产生有益效果的药品。
(2)分体结构可设计成不可复用结构,一次性使用提升消融探针的使用安全。
(3)可配合多种消融方式的消融探针使用,适用性强。
(4)外套管的滑动,改变了覆盖内探针的绝热层的长短,从而该表冷冻区域的大小和长短,即实现可变冰球。
附图说明
图1是螺纹分接式外套管消融探针的剖面示意图
图2是旋扭断接式外套管消融探针的剖面示意图
图3是鲁尔分接式外套管消融探针的剖面示意图
图4是外鞘调控式外套管消融探针的剖面示意图
图5外鞘的表面结构结构示意图
图中:1-螺纹分接式外套管消融探针、101-第一内探针、102-第一外套管、103-第一分体构件、104-第二分体构件、105-第一手柄、2-旋扭断接式外套管消融探针、201-第二内探针、202-第二外套管、203-第三分体构件、204-第四分体构件、205-第二手柄、3-鲁尔分接式外套管消融探针、301-第三内探针、302-第三外管、303-第五分体构件、304-第六分体构件、305-第三手柄、4-外鞘调控式外套管消融探针、401-第四内探针、402-第四外套管、403-第七分体构件、404-第八分体构件、405-第四手柄、406-外鞘、407-滑块、408-通槽、409-限位槽、410-刻度标识
具体实施方式
本发明中所指的药剂包括止血剂、栓塞剂、化疗药、生物制剂等药剂,对止血、局部化疗和防止种植转移存在积极的效果。所指的“远端”和“近端”分别指内探针的尖端和靠近手柄的一端。所指的绝热管优选为真空套,气凝胶填充、电热膜和电阻丝也是可选绝热结构;所指的绝缘管中的绝缘指的是电绝缘,包括通过选用电绝缘材料的电绝缘方式或涂抹电绝缘涂层的绝缘结构。内探针选用冷冻消融探针或涉及冷冻消融的探针且设有绝热管套接在内探针的外表面,而一种优选的方案是将冷冻消融探针及带有冷冻功能的消融探针中的绝热结构拆除,即内探针为不带绝热结构的冷冻探针,仅靠本发明的绝热管即可进行隔热;同时,调整绝热外套管即可对内探针远端产生的冰球大小尺寸进行调控。当内探针为电冷消融探针的时候,绝热管还应该带有绝缘结构;同时,通过调控外套管可以调整电消融探针裸露的电极面积或电极数量从而调节电消融的范围;若需要通过绝热管进行电消融,外套管的远端带有至少一个电极,可通过外套管作为电极进行独立的电消融或将外套管与内探针之间做绝缘形成内探针与外套管多电极结构进行电消融,电极与直流电发生器和/或电脉冲发生器电连接。冷冻消融时,通过拆分分体构件可使外套管沿内探针表面作轴向相对运动,从而隔绝和调整内探针的消融范围。
本发明中任何一种实施方式的外绝缘结构均可以是金属材质或非金属材质,优选的采用金属结构,金属结构具有导电性,在需要结合电消融的时候,无需像非金属结构一样直连电极,可以通过金属结构进行电传导;
为了更好的理解本发明,下面结合具体实施例和附图对本发明进行进一步的描述。然而,本领域技术人员将清楚,可以在没有这些特定细节的情况下实践本公开的实施例。此外,这里描述的本公开的特定实施例是作为示例提供的,并且不应该用于将本发明的范围限制于这些特定实施例。在其他情况下,没有详细描述或示出公知的材料,组件,过程,控制器组件,软件,电路,时序图和/或解剖结构,以避免不必要地模糊实施例。
实施例1:参照图1,图1是螺纹分接式外套管消融探针1,包括第一内探针101、第一外套管102、第一分体构件103、第二分体构件104和第一手柄105,第一内探针101可以是冷冻消融探针或电冷消融探针也可以是不设有绝热结构的冷冻消融探针或电冷消融探针,第一内探针101的表面设有刻度。第一外套管102与第一分体构件103同心同轴固定,第一外套管102连同第一分体构件103套接在第一内探针101上并且形成滑动连接,第一手柄105的一端和第二分体构件104的一端固定,第一分体构件103和第二分体构件104螺纹连接,通过该螺纹连接结构使第一分体构件103和第二分体构件104形成可以重复拆分连接结构,当第一分体构件103与第二分体构件104连接时,第一外套管102与第一内探针101不可滑动,应注意螺纹连接只是可以重复拆分连接结构的一种优选连接方式,常用的可以重复拆分连接结构例如:卡接结构、旋接结构(通过旋转连接或分离)或过盈配合结构均可应用于本发明,例如:参考图3,图3中第五分体构件303和第六分体构件304为鲁尔接头,鲁尔接头同样可以形成可以重复拆分连接结构。当第一分体构件103和第二分体构件104拆分时,第一内探针101、第二分体构件104和第一手柄105为一组装置,第一外套管102和第一分体构件103为一组装置相对前一组装置脱离。第一外套管102配合冷冻消融探针时选用绝热管(优选为真空绝热管),若通过第一外套管102进行电消融则选用远端带有电极的部分绝缘管,若通过第一内探针101进行电消融则选用带有电绝缘功能的绝热管作为第一外套管102,若第一内探针101为电冷结合消融的探针则第一外套管102可选用带有绝热和至少部分绝缘的第一外套管102。使用时,将螺纹分接式外套管消融探针1置入靶区,随后可以选择直接进行消融也可以根据需求将第一分体构件103和第二分体构件104拆分,抽出第一内探针101使得第一外套管102形成一个靶区与外界的通道,使用者可以以第一外套管102为引导通道向靶区输入药品,药品包括但不限于固体和流体类的止血剂、生物治疗药物或化学治疗药物,再将固定在第一手柄105的第一内探针101穿入带有第一分体构件103的第一外套管102并将第一分体构件103和第二分体构件104组合或通过调配第一外套管102遮蔽第一内探针101的面积以调控消融区,随后对靶区进行消融,消融完成后在取出螺纹分接式外套管消融探针1前或取出过程中,可以根据需求将第一分体构件103和第二分体构件104拆分,通过第一外套管102向靶区输入药品,药品包括但不限于固体和流体类的止血剂、生物治疗药物或化学治疗药物,用来止血、治疗或防止肿瘤的针道种植转移。
实施例2:参考图2,图2是旋扭断接式外套管消融探针2,包括第二内探针201、第二外套管202、第三分体构件203、第四分体构件204和第二手柄205,第二内探针201可以是冷冻消融探针或电冷消融探针也可以是不设有绝热结构的冷冻消融探针或电冷消融探针,第二外套管202与第三分体构件203同心同轴固定,第二外套管202连同第三分体构件203套接在第二内探针201上并且形成滑动连接,第二手柄205的一端和第四分体构件204的一端固定,第三分体构件203和第四分体构件204采用不可重复连接结构,第三分体构件203和第四分体构件204拆分后不可复原,不可重复连接结构包括但不限于扭断式结构、压断式结构或拉断式结构,当第三分体构件203与第四分体构件204连接时,第二外套管202与第二内探针201不可滑动。当第三分体构件203和第四分体构件204拆分时,第二内探针201、第四分体构件204和第二手柄205为一组装置,第二外套管202和第三分体构件203为一组装置相对前一组装置脱离且损毁第三分体构件使装置无法再次连接。第二外套管202配合冷冻消融探针选用绝热管(优选为真空绝热管),若通过第二外套管202进行电消融则选用远端带有电极的部分绝缘管,若通过第二内探针201进行电消融则选用带有电绝缘功能的绝热管作为第二外套管202,若第二内探针201为电冷结合消融的探针则第二外套管202可选用带有绝热和至少部分绝缘的第二外套管202。使用时,将旋扭断接式外套管消融探针2置入靶区,通过调配第二外套管202遮蔽第二内探针201的面积以调控消融区或直接对靶区进行消融,消融完成后在取出旋扭断接式外套管消融探针2前或取出过程中,可以根据需求将第三分体构件203和第四分体构件204拆分,通过第二外套管202向靶区输入药品,药品包括但不限于固体和流体类的止血剂、生物治疗药物或化学治疗药物,用来止血、治疗或防止肿瘤的针道种植转移。
实施例3:参考图4,图4是外鞘调控式外套管消融探针4,包括第四内探针401、第四外套管402、第七分体构件403、第八分体构件404、第四手柄405、外鞘406、滑块407、通槽408、限位槽409和刻度标识410,第四内探针401可以是冷冻消融探针或电冷消融探针也可以是不设有绝热结构的冷冻消融探针或电冷消融探针。第四外套管402与第七分体构件403同心同轴固定,第四外套管402连同第七分体构件403套接在第四内探针401上并且形成滑动连接,第四手柄405的一端和第八分体构件404的一端固定,第七分体构件403和第八分体构件404可以选择通过重复拆分连接结构连接,常用的可以重复拆分连接结构例如:卡接结构、旋接结构(通过旋转连接或分离)或过盈配合结构均可应用于本发明,也可以选择通过不可重复连接结构连接,不可重复连接结构包括但不限于扭断式结构、压断式结构或拉断式结构,当第七分体构件403与第八分体构件404连接时,第四外套管402与第四内探针401不可滑动,当第七分体构件403和第八分体构件404拆分时,第四内探针401、第八分体构件404和第四手柄405为一组装置,第四外套管402、第七分体构件403、外鞘406、滑块407和限位槽409为一组装置相对前一组装置脱离。外鞘406与第七分体构件403固定连接并且非固定的套接在第四外套管402上,外鞘406上设有通槽408,通过通槽408可以使滑块407穿过外鞘406与第四外套管402固定,推动滑块407在通槽408滑动的同时第四外套管402协同滑动,同时滑块407向左右扳动时可以使第四外套管402相对第四外套管402的轴心旋转,限位槽409可以在第四外套管402调整到需要位置时卡住左右扳动滑块407达到限位效果,限位方式不仅限于扳动滑块,其他的常用限位方式也是可选用的方式。外鞘406上设有刻度标识410用来标记第四外套管402相对滑动的距离。第四外套管402配合冷冻消融探针选用绝热管(优选为真空绝热管)作为第四外套管402,若通过第四外套管402进行电消融则选用远端带有电极的部分绝缘管,若通过第四内探针401进行电消融则选用带有电绝缘功能的绝热管作为第四外套管402,若第四内探针401为电冷结合消融的探针则第四外套管402可选用带有绝热和至少部分绝缘的第四外套管402。使用时,将外鞘调控式外套管消融探针4置入靶区,随后可以选择直接进行消融也可以根据需求将第七分体构件403和第八分体构件404拆分,抽出第四内探针401使得第四外套管402形成一个靶区与外界的通道,使用者可以以第四外套管102为引导通道向靶区输入药品,药品包括但不限于固体和流体类的止血剂、生物治疗药物或化学治疗药物,再将固定在第四手柄405的第四内探针401穿入带有第七分体构件403的第四套管402并将第四分体构件403和第八分体构件404组合,随后对靶区进行消融,消融完成后在取出外鞘调控式外套管消融探针4前或取出过程中,可以根据需求将第七分体构件403和第八分体构件404拆分,通过第四外套管402向靶区输入药品,药品包括但不限于固体和流体类的止血剂、生物治疗药物或化学治疗药物,用来止血、治疗或防止肿瘤的针道种植转移。
以上对本发明的实施例进行了详细说明,但所述内容仅为本发明的较佳实施例,不能被认为用于限定本发明的实施范围。凡依本发明范围所作的均等变化与改进等,均应仍归属于本专利涵盖范围之内。

Claims (13)

1.一种带有冷冻功能的分体式外套管消融探针,包括内探针、外套管和手柄部分,所述内探针与所述外套管滑动连接,所述内探针的一端与所述手柄部分的一端固定,其特征在于:包括拆分组件,所述拆分组件包括第一分体构件和第二分体构件,所述第一分体构件与所述第二分体构件可分离连接,所述第一分体构件与所述外套管固定,所述第二分体构件与所述手柄部分固定;所述外套管是绝热管;所述内探针是不设有绝热结构的冷冻消融探针或电冷消融探针。
2.根据权利要求1所述的分体式外套管消融探针,其特征在于:所述内探针是冷冻消融探针或电冷消融探针。
3.根据权利要求1或2所述的分体式外套管消融探针,其特征在于:所述绝热管设有电绝缘层。
4.根据权利要求1或2所述的分体式外套管消融探针,其特征在于:所述外套管的远端设有至少一个电极,电极以外部分为绝缘结构。
5.根据权利要求1所述的分体式外套管消融探针,其特征在于:所述内探针的表面设有刻度。
6.根据权利要求1所述的分体式外套管消融探针,其特征在于:所述消融探针还包括外鞘,所述外鞘的一端与所述第一分体构件固定,所述外鞘上设有通槽,所述外鞘还包括滑钮,所述滑钮穿过所述通槽与所述外套管固定。
7.根据权利要求6所述的分体式外套管消融探针,其特征在于:所述外鞘上设有刻度和限位槽。
8.根据权利要求1所述的分体式外套管消融探针,其特征在于:所述第一分体构件和所述第二分体构件的可分离连接结构为可复用分离结构。
9.根据权利要求8所述的分体式外套管消融探针,其特征在于:所述可复用分离结构为卡接结构、旋接结构或过盈配合结构。
10.根据权利要求1所述的分体式外套管消融探针,其特征在于:所述第一分体构件和所述第二分体构件的可分离连接结构为不可复用分离结构。
11.根据权利要求10所述的分体式外套管消融探针,其特征在于:所述不可复用分离结构为扭断式结构、压断式结构或拉断式结构。
12.一种如权利要求1所述带有冷冻功能的分体式外套管消融探针的消融方法,其特征在于:将消融探针置入靶区,将第一分体构件和第二分体构件分离并抽出内探针使外套管与靶区形成通道,向外套管内注入药剂或通过外套管进行穿刺活检,将内探针置入外套管并将第一分体构件和第二分体构件连接或将内探针置入外套管后调整内探针与外套管的相应位置以调整消融区,启动消融探针对靶区进行消融。
13.根据权利要求12所述的消融方法,其特征在于:完成消融后将分离第一分体构件和第二分体构件并抽离内探针,向外套管再次注入药剂。
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CN109833091A (zh) * 2017-11-28 2019-06-04 杭州诺诚医疗器械有限公司 消融针组件及消融系统
CN210354888U (zh) * 2019-03-12 2020-04-21 海杰亚(北京)医疗器械有限公司 一种冷冻消融针
CN111012474A (zh) * 2019-09-17 2020-04-17 日照天一生物医疗科技有限公司 一种冷冻消融针及其消融系统
CN212879548U (zh) * 2020-06-26 2021-04-06 天津美电医疗科技有限公司 一种带有冷冻功能的分体式外套管消融探针

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