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CN110604873A - 用于心脏传导束起搏的磁导航引导可撕开鞘管 - Google Patents

用于心脏传导束起搏的磁导航引导可撕开鞘管 Download PDF

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CN110604873A
CN110604873A CN201910841634.2A CN201910841634A CN110604873A CN 110604873 A CN110604873 A CN 110604873A CN 201910841634 A CN201910841634 A CN 201910841634A CN 110604873 A CN110604873 A CN 110604873A
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electrode
sheath
semi
magnetic navigation
cardiac conduction
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张常莹
党时鹏
王如兴
李库林
刘晓宇
郑杰
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Wuxi Peoples Hospital
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Wuxi Peoples Hospital
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Priority to CN201910841634.2A priority Critical patent/CN110604873A/zh
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Priority to US17/008,644 priority patent/US11826523B2/en
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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    • A61M25/00—Catheters; Hollow probes
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
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Abstract

本发明涉及用于心脏传导束起搏的磁导航引导可撕开鞘管，包括鞘管本体和固定连接其后端的接头，鞘管本体包括前部柔软段和后部固定段，前部柔软段可任意弯曲；前部柔软段靠近头端的外表面上设有若干对半环形磁体，每对半环形磁体中的两个半环形磁体均对称设置并组成环形，两个半环形磁体之间留有间隙；前部柔软段头端设有三个周向均布设置的电极，三个电极能够任意两两组合，构成三个用于心腔内电位记录和定位的电极对；每个电极均连接有一根电极导线，鞘管本体靠近尾端的部位设有电极尾线接口，三根电极导线的另一端固定设置在电极尾线接口内。本发明利于心腔内电位记录和定位，并便于与心腔接触，稳定贴靠心内膜，确保起搏电极稳定旋出。

Description

用于心脏传导束起搏的磁导航引导可撕开鞘管
技术领域
本发明涉及一种用于心脏传导束起搏的磁导航引导可撕开鞘管，属于心脏起搏电生理技术领域。
背景技术
人工心脏起搏在临床应用已有60余年的历史，随着生物工程技术的迅速发展，各种新的心脏起搏技术不断推出。传统的心脏起搏技术是将起搏电极安放在心脏肌壁表面，通过简单的电刺激来使心脏恢复跳动。而新的心脏起搏技术将起搏电极置于心脏壁内的心脏传导束上，通过起搏心脏传导束来实现人工起搏，这样的人工心脏起搏方式更加接近生理性起搏，能够减少心衰发生或改善心功能。
目前心脏传导束起搏存在的难点主要有以下几点：1、心脏传导束无法直视；2、电解剖不完全等于组织解剖；3、心脏传导束周围毗邻组织多样；4、心脏不停跳动；5心脏解剖变异、结构发生变化等；6、术者的习惯、技巧、感觉等方面参差不齐。以上的这些难点导致心脏传导束起搏存在成功率较低、学习曲线长、手术时间长等问题。
通过研究发现，心脏传导束起搏存在上述问题的主要原因之一是现有的用于植入起搏电极的鞘管不够先进，预塑形鞘管及可调弯鞘管虽然可以提供不同的支撑，但调整范围有限，精确度不高，在旋入起搏电极过程中，角度、深度不便控制，旋入太深会有心肌穿孔的风险，旋入角度也往往难以到达预定区域。存在心脏扩大、解剖变异的情况时，在常规解剖区域内会找不到电位。
发明内容
本发明的目的在于克服现有技术中存在的不足，提供一种结构巧妙，设计合理，使用方便的用于心脏传导束起搏的磁导航引导可撕开鞘管。
按照本发明提供技术方案：用于心脏传导束起搏的磁导航引导可撕开鞘管，包括鞘管本体和固定连接其后端的接头，所述接头内有单向止漏阀，所述鞘管本体内部中空；其特征在于：所述鞘管本体包括一体设置的前部柔软段和后部固定段，所述前部柔软段可任意弯曲；所述前部柔软段靠近头端的外表面上设有若干对半环形磁体，每对半环形磁体中的两个半环形磁体均对称设置并组成环形，两个半环形磁体之间留有供切开刀通过的间隙；所述前部柔软段的头端还设有三个周向均布设置的电极，三个所述电极能够任意两两组合，构成三个电极对，三个电极对可记录心脏局部的三个双极电位，用于心腔内电位记录和定位；每个电极均连接有一根电极导线，所述电极导线沿着鞘管本体的长度方向埋设在鞘管本体壁内，鞘管本体靠近尾端的部位设有电极尾线接口，三根电极导线的另一端固定设置在电极尾线接口内。
作为本发明的进一步改进，所述前部柔软段的长度为6～8cm，内径大于等于1.88mm。
作为本发明的进一步改进，所述后部固定段的长度为35～45cm，内径大于等于1.88mm。
作为本发明的进一步改进，所述鞘管本体外壁上设有切开引导线，所述接头尾端设有与切开引导线后端对应的切开导口，所述切开引导线前端从两个半环形磁体之间的间隙通过。
作为本发明的进一步改进，所述接头侧壁上还连接有进液管，所述进液管后端为进液口，进液管前端与接头内部相通。
作为本发明的进一步改进，所述半环形磁体的数量为2～4对。
作为本发明的进一步改进，若干对半环形磁体在前部柔软段外表面上等间距均布设置。
作为本发明的进一步改进，所述前部柔软段的材质为生物相容性的高分子材料，所述电极的材质为生物相容性的惰性金属材料。
作为本发明的进一步改进，所述电极的表面优选设置为光滑圆润的弧形。
本发明与现有技术相比，具有如下优点：
1)、本发明结构巧妙，设计合理，通过在前部柔软段上设置若干对半环形磁体，使得前部柔软段在外界磁场环境【磁导航系统】中可任意弯曲，调整方向及角度，方便寻找传导系统电位，并便于与心腔接触，稳定贴靠心内膜，确保起搏电极稳定旋出；前部柔软段头端设有三个电极，三个所述电极能够任意两两组合，构成三个电极对，三个电极对可记录心脏局部的三个双极电位，用于心腔内电位记录和定位。
2)、本发明可通过进液管的进液口注射造影剂，便于造影以显示心内膜。
3)、本发明设置了切开引导线，切开引导线前端从两个半环形磁体之间的间隙通过，这样常规的切开刀可准确切开鞘管本体，且不会受半环形磁体阻隔，方便取出鞘管。
附图说明
图1为本发明实施例的整体结构示意图。
图2为图1中的A-A面剖视放大示意图。
图3为图1中的B部放大示意图。
图4为图1中的C部放大示意图。
附图标记说明：1-鞘管本体、1a-前部柔软段、1b-后部固定段、2-接头、3-半环形磁体、4-间隙、5-电极、6-电极导线、7-电极尾线接口、8-进液管、8a-进液口、9-切开引导线、10-切开导口。
具体实施方式
下面结合具体附图和实施例对本发明作进一步说明。
如图1～图4所示，实施例公开了一种用于心脏传导束起搏的磁导航引导可撕开鞘管，包括鞘管本体1和固定连接其后端的接头2，所述接头2内有单向止漏阀，所述鞘管本体1内部中空，鞘管本体1包括一体设置的前部柔软段1a和后部固定段1b，所述前部柔软段1a可任意弯曲；所述前部柔软段1a靠近头端的外表面上设有若干对半环形磁体3，每对半环形磁体3中的两个半环形磁体3均对称设置并组成环形，两个半环形磁体3之间留有供切开刀通过的间隙4；所述前部柔软段1a的头端还设有三个周向均布设置的电极5，每个电极5均连接有一根电极导线6，所述电极导线6沿着鞘管本体1的长度方向埋设在鞘管本体1壁内，鞘管本体1靠近尾端的部位设有电极尾线接口7，三根电极导线6的另一端固定设置在电极尾线接口7内。
具体使用时，先按常规方式植入鞘管，由于鞘管的前部柔软段1a设有若干对半环形磁体3，这样前部柔软段1a在外界磁场环境【磁导航系统】中可任意弯曲，通过磁导航调整其方向及角度，便于寻找心脏传导系统电位，并利于与心腔接触，稳定贴靠心内膜，确保起搏电极稳定旋出；精确度提高也可有效避免心肌穿孔，减少手术时间，降低手术风险，提高手术成功率；而三个所述电极5能够任意两两组合，构成三个电极对，三个电极对可记录心脏局部的三个双极电位，用于心腔内电位记录和定位。
如图1所示，本实施例中，所述接头2侧壁上还连接有进液管8，所述进液管8后端为进液口8a，进液管8前端与接头2内部相通。如此设置，通过进液口8a可注入造影剂，便于造影显示心内膜，方便操作。
如图1所示，本实施例中，所述前部柔软段1a外表面上设置有两对半环形磁体3，在实际生产中可以设置2～4对半环形磁体3，且若干对半环形磁体3在前部柔软段1a外表面上呈等间距均布设置。如此设置，可以保证前部柔软段1a在磁导航下具有足够灵活的弯曲度。
本发明中，所述鞘管本体1的长度可灵活设置，一般来说，所述前部柔软段1a的长度为6～8cm，所述后部固定段1b的长度为35～45cm，前部柔软段1a和后部固定段1b的内径均大于等于1.88mm。如此设置，前部柔软段1a有足够的长度做弯曲运动，基本就可以满足所有的临床需求。
如图1所示，本实施例中，所述鞘管本体1外壁上设有切开引导线9，所述接头2尾端设有与切开引导线9后端对应的切开导口10，所述切开引导线9前端从两个半环形磁体3之间的间隙4通过。如此设置，采用常规的切开刀即可准确切开鞘管本体1，且不会受半环形磁体3阻隔，方便取出鞘管。
本发明中，所述前部柔软段1a的材质优选为生物相容性的高分子材料，如聚醚前端酰胺、聚氨酯或尼龙材料。所述电极5的材质优选为生物相容性的惰性金属材料，如铂铱合金。所述半环形磁体3采用剩磁较大的永磁材料制成，如钕铁硼材料、铁氧体材料。所述半环形磁体3和电极5均可采用医用胶水固定粘结在前部柔软段1a上，医用胶水可选用4011、4014、3011等。
本发明中，所述电极5的表面优选设置为光滑圆润的弧形。如此设置，不会对心腔造成划伤，从而达到保护作用。
以上所描述的仅为本发明的较佳实施例，上述具体实施例不是对本发明的限制。在本发明的技术思想范畴内，可以出现各种变形及修改，凡本领域的普通技术人员根据以上描述所做的润饰、修改或等同替换，均属于本发明所保护的范围。

Claims (9)

1.用于心脏传导束起搏的磁导航引导可撕开鞘管，包括鞘管本体(1)和固定连接其后端的接头(2)，所述接头(2)内有单向止漏阀，所述鞘管本体(1)内部中空；其特征在于：所述鞘管本体(1)包括一体设置的前部柔软段(1a)和后部固定段(1b)，所述前部柔软段(1a)可任意弯曲；所述前部柔软段(1a)靠近头端的外表面上设有若干对半环形磁体(3)，每对半环形磁体(3)中的两个半环形磁体(3)均对称设置并组成环形，两个半环形磁体(3)之间留有供切开刀通过的间隙(4)；所述前部柔软段(1a)的头端还设有三个周向均布设置的电极(5)，三个所述电极(5)能够任意两两组合，构成三个电极对，三个电极对可记录心脏局部的三个双极电位，用于心腔内电位记录和定位；每个电极(5)均连接有一根电极导线(6)，所述电极导线(6)沿着鞘管本体(1)的长度方向埋设在鞘管本体(1)壁内，鞘管本体(1)靠近尾端的部位设有电极尾线接口(7)，三根电极导线(6)的另一端固定设置在电极尾线接口(7)内。
2.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述前部柔软段(1a)的长度为6～8cm，内径大于等于1.88mm。
3.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述后部固定段(1b)的长度为35～45cm，内径大于等于1.88mm。
4.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述鞘管本体(1)外壁上设有切开引导线(9)，所述接头(2)尾端设有与切开引导线(9)后端对应的切开导口(10)，所述切开引导线(9)前端从两个半环形磁体(3)之间的间隙(4)通过。
5.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述接头(2)侧壁上还连接有进液管(8)，所述进液管(8)后端为进液口(8a)，进液管(8)前端与接头(2)内部相通。
6.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述半环形磁体(3)的数量为2～4对。
7.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：若干对半环形磁体(3)在前部柔软段(1a)外表面上等间距均布设置。
8.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述前部柔软段(1a)的材质为生物相容性的高分子材料，所述电极(5)的材质为生物相容性的惰性金属材料。
9.如权利要求1所述的用于心脏传导束起搏的磁导航引导可撕开鞘管，其特征在于：所述电极(5)的表面优选设置为光滑圆润的弧形。
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