WO2013086698A1 - 具有抗扭结外管的球囊扩张导管 - Google Patents

具有抗扭结外管的球囊扩张导管 Download PDF

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Publication number
WO2013086698A1
WO2013086698A1 PCT/CN2011/083956 CN2011083956W WO2013086698A1 WO 2013086698 A1 WO2013086698 A1 WO 2013086698A1 CN 2011083956 W CN2011083956 W CN 2011083956W WO 2013086698 A1 WO2013086698 A1 WO 2013086698A1
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Prior art keywords
outer tube
balloon
dilatation catheter
balloon dilatation
guide wire
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Application number
PCT/CN2011/083956
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English (en)
French (fr)
Inventor
桂红
陈威
Original Assignee
东莞市迪凯精密管材有限公司
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Priority to PCT/CN2011/083956 priority Critical patent/WO2013086698A1/zh
Publication of WO2013086698A1 publication Critical patent/WO2013086698A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters

Definitions

  • the present invention relates to the field of cardiac medical device technology, and more particularly to a balloon dilatation catheter having an anti-kink outer tube. Background technique
  • the type of balloon dilatation catheter can be roughly divided into two types, one is RX type (rapid exchange type), and the other type is OTW type (coaxial type).
  • RX can quickly replace the balloon dilatation catheter without replacing the guide wire, which simplifies the surgical procedure and simplifies the operation.
  • the OTW type has to re-thread the guide wire or use the extended guide wire when replacing the balloon catheter. Better tracking and operability, and the doctor's operation requirements are relatively high, requiring two people to operate, generally very complex lesions, will use this system. Therefore, the RX type has become the current mainstream. As shown in Fig.
  • the balloon dilatation catheter is composed of a handle 1, a stainless steel hypotube 2, an outer tube 3, a balloon 4, and a balloon tip 5 in sequence, and the balloon is formed.
  • 4 is provided with an inner tube 6 connected to the outer tube 3 and the tip end, and a guide wire port 31 is arranged on the side wall of the outer tube 3.
  • the outer tube is made of a biocompatible high-grade material, in the polymer material conduit
  • the inner tube made of a special material is worn on the side, and the balloon catheter replacement during the operation can be easily realized.
  • a third is used for fixed repair Stent.
  • the exchange here means that only one guide wire can be used to complete the insertion of multiple balloon catheters.
  • the balloon catheter has a tip at the beginning of the operation. Since the outer tube portion composed of the polymer material has a small diameter, there is no guide wire support in the cavity of the outer tube during the operation, so the support force is weak, and the outer tube between the guide wire port and the hypotube often produces a kink. Phenomenon, the passage of the balloon dilatation catheter, the tracking, the poor penetration, affecting the smooth operation. Summary of the invention
  • the present invention is directed to a balloon dilatation catheter having an anti-kink outer tube which solves the above problems in view of the fact that the outer tube portion of the RX-type balloon dilatation catheter has a small supporting force and poor kink resistance.
  • a balloon dilatation catheter having an anti-kink outer tube, wherein the balloon dilatation catheter is sequentially connected by a handle, a stainless steel hypotube, an outer tube, a balloon, and a balloon tip, and the balloon is disposed in connection with the outer tube and the tip end.
  • the inner tube is provided with a guide wire opening on the side wall of the outer tube; the outer tube is provided with a reinforcing outer tube from the connecting end of the hypotube to the side of the guide wire.
  • transition tube between the outer tube and the balloon is thinner than the outer tube.
  • the wire is gradually reduced in diameter from the inlet direction of the hypotube guide wire.
  • the reinforcing outer tube is a wire braid outer tube.
  • the reinforcing outer tube is a fiber braid outer tube.
  • the reinforced outer tube is a staple fiber co-extruded reinforced outer tube.
  • the beneficial effects of the present invention are as follows: the balloon dilatation catheter of the present invention, the balloon dilatation catheter is sequentially connected by a handle, a hypotube, an outer tube, a balloon, and a balloon tip, and the balloon is provided with an outer tube and a tip.
  • a connecting inner tube a guide wire inlet is arranged on the side wall of the outer tube; a reinforcing outer tube is arranged on the wall layer of the outer tube from the connection end of the hypotube to the inlet of the guide wire; during the operation, the guide wire is from the tip
  • the outer tube is added due to the wall layer at the end of the hypotube connection to the outlet wire, the support force of the outer tube is enhanced, the torsion resistance is enhanced, and the guide wire and the hypotube are reduced.
  • the external tube kinking occurs, improving the passage, tracking and traversing of the balloon dilatation catheter to ensure smooth operation.
  • FIG. 1 is a schematic view showing the structure of a prior art balloon dilatation catheter
  • Figure 3 is a partial enlarged view of a portion A in Figure 2;
  • FIG. 4 is a schematic cross-sectional view showing a structure of a wire braided layer of the outer tube of the balloon dilatation catheter of the present invention
  • Fig. 5 is a schematic cross-sectional view showing the outer structure of the balloon dilatation catheter of the present invention as a fiber braid layer. detailed description
  • a balloon dilatation catheter having an anti-kink outer tube
  • the balloon dilatation catheter being sequentially connected by a handle 1, a stainless steel hypotube 2, an outer tube 3, a balloon 4, and a balloon tip 5, respectively, in the balloon 4 Set with outer tube 3 and tip
  • the end tube 6 is connected to the end, and the side wall of the outer tube 3 is provided with a guide wire opening 31; the wall layer of the outer tube 3 from the connecting end of the hypotube 2 to the inlet 31 of the guide wire is provided with a reinforcing outer tube 32.
  • the outer tube 3 and the balloon 4 are connected to the transition thin tube 7 which is thinner than the outer tube 3, so that the outer diameter from the outer tube 3 to the balloon 4 is gradually reduced, and the supporting force at the rear end of the pushing is increased, and the torsion is resistant. At the same time, it does not affect the ability of the front end to pass through the narrow lesion.
  • the steel wire 8 extending into the outer tube 3 is fixed at the junction of the hypotube 2 and the outer tube 3, and the steel wire 8 is welded and fixed.
  • the diameter of the wire 8 is gradually reduced from the inlet direction of the hypotube 2 guide wire.
  • the material for reinforcing the woven mesh 32 can be selected according to different materials.
  • a copper wire woven mesh (as shown in FIG. 4) or a fiber woven mesh can be selected (see FIG. 5).
  • the production process usually adopts: Three-layer precision coextrusion technology: The inner layer outer layer or the same layer polymer material such as PA intermediate layer adopts online weaving technology, and according to the idea of the invention, glass can also be added to the raw material. Short fibers, extruded into an outer tube 3 at one time. All three methods can enhance the effect to a large extent. However, the fiber woven is the best in the three ways, the wire woven co-extrusion is difficult, and the short-fiber disorder co-extrusion cannot be oriented enhanced.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种具有抗扭结外管的球囊扩张导管，由手柄（1）、海波管（2）、外管（3）、球囊（4）、球囊尖端（5）依次连接而成，球囊（4）内设置与外管（3）及球囊尖端（5）连接的内管（6），外管（3）的侧壁上设置有导丝入口（31）；所述外管（3）的由海波管（2）连接端到导丝入口（31）处的管壁层设置增强外管（32）。在手术过程中，球囊扩张导管沿导丝推进，并不时加以旋转以达到顺利推进及通过狭窄部位的目的。由于海波管（2）连接端到导丝入口（31）处的管壁设置定向增强，增强了这段外管的抗扭能力，以及辅助提高推进时的支撑力，减少露在导丝外的外管部分的扭结现象发生，有效的提升了球囊扩张导管的通过性、跟踪性、穿过性，保证了手术顺利进行。

Description

具有抗扭结外管的球囊扩张导管
技术领域
本发明涉及心脏医疗器械技术领域， 尤其是指具有抗扭结外管的球囊扩张导管。 背景技术
在医学领域中， 经皮冠状动脉腔内成形术已逐步走向成熟， 作为该术的重要器 械装置一球囊扩张导管也随着技术的不断进步而快速更新换代。
目前球囊扩张导管 （PTCA) 类型大体可以分成两类， 一类是 RX型 （快速交换 型）， 一类是 OTW型 （同轴型）。 RX可以快速更换球囊扩张导管而不更换导丝的的 优势， 从而简化手术过程， 简化手术难度； OTW型则更换球囊导管的时候要重新穿 导丝或者使用延长导丝， 它的优势有更好地跟踪性与操作性， 同时对医生的操作要 求也比较高， 需要两个人操作， 一般非常复杂的病变， 才会选用这个系统。 因而 RX 型成了目前的主流， 如图 1所示， 球囊扩张导管依次由手柄 1、 不锈钢海波管 2、 外 管 3、 球囊 4、 球囊尖端 5依次连接而成组成， 球囊 4内设置与外管 3及尖端连接的 内管 6， 外管 3的侧壁上设置导丝口 31， 一般情况下， 外管由生物兼容性好的高分 材料制造， 在高分子材料导管侧面穿出一个特殊材料制作的内管， 同时可以简便的 实现手术过程中的球囊导管更换。 （快速交换是： 一个完整的 PTCA手术最少会用到 两个球囊扩张导管， 第一个是扩张病变， 第二个是输送支架。 有的时候还会用第三 个， 用来的固定修复支架。 这里的交换是指可以只用一根导丝去完成多条球囊导管 的插入。） 这样的结构虽然给手术带来很好便利性， 在手术过程中， 球囊导管有尖端 开始， 由于高分子材料构成的外管部分在直径很小， 在手术时这部分外管的腔内没 有导丝支撑， 因此其支撑力弱， 常常在导丝口与海波管间的外管产生扭结现象， 导 致球囊扩张导管的通过性、 跟踪性、 穿过性变差， 影响手术顺利进行。 发明内容
本发明在于针对目前 RX型球囊扩张导管外管部分支撑力小， 抗扭结性差的问 题， 而提供解决以上问题的具有抗扭结外管的球囊扩张导管。
为达到上述目的， 本发明采用如下技术方案： 具有抗扭结外管的球囊扩张导管， 所述球囊扩张导管依次由手柄、 不锈钢海波 管、 外管、 球囊、 球囊尖端依次连接而成， 球囊内设置与外管及尖端连接的内管， 外管的侧壁上设置导丝口； 所述外管的由海波管连接端到导丝口处的管壁层设置增 强外管。
其中所述外管和球囊间连接比外管细的过渡细管。
其中所述海波管与外管连接处固定延伸至外管内的钢丝
其中所述钢丝由海波管向导丝进口方向直径逐渐减小。
其中所述增强外管为金属丝编织层外管。
其中所述增强外管为纤维编织层外管。
其中所述增强外管为短纤共挤增强外管。
本发明的有益效果在于： 本发明的球囊扩张导管， 球囊扩张导管依次由手柄、 海波管、 外管、 球囊、 球囊尖端依次连接而成， 球囊内设置与外管及尖端连接的内 管， 外管的侧壁上设置导丝入口； 所述外管的由海波管连接端到导丝入口处的管壁 层设置增强外管； 在手术过程中， 导丝从尖端进入后推进、 旋转行进时， 由于海波 管连接端到导出丝口处的管壁层设置加增强外管， 增强这段外管的支撑力， 增强抗 扭能力， 减少导丝口与海波管间的外管扭结现象发生， 提升球囊扩张导管的通过性、 跟踪性、 穿过性， 保证手术顺利进行。 附图说明
图 1为现有技术球囊扩张导管结构示意图；
图 2为本发明结构示意图；
图 3为图 2中 A处局部放大示意图；
图 4为本发明球囊扩张导管外管为金属丝编织层剖面结构示意图；
图 5为本发明球囊扩张导管外管为纤维编织层剖面结构示意图。 具体实施方式
下面结合附图 2-5对本发明作进一步阐述：
设置具有抗扭结外管的球囊扩张导管，所述球囊扩张导管依次由手柄 1、不锈钢 海波管 2、 外管 3、 球囊 4、 球囊尖端 5依次连接而成， 球囊 4内设置与外管 3及尖 端连接的内管 6， 外管 3的侧壁上设置导丝口 31 ; 所述外管 3的由海波管 2连接端 到导丝入口 31处的管壁层设置增强外管 32。
外管 3和球囊 4间连接比外管 3细的过渡细管 7，使从外管 3向球囊 4方向外径 以逐渐变小的设计， 增加推进时后端的支撑力， 抗扭的同时又不影响前端通过狭窄 病变部分的能力。
为了进一步增强导丝入口 31与海波管 2间的外管 3的强度和抗扭能力， 在海波 管 2与外管 3连接处固定延伸至外管 3内的钢丝 8，钢丝 8焊接固定在海波管 2与外 管 3的连接处。 为方便对导丝造成干扰， 以增加通过性能， 钢丝 8由海波管 2向导 丝进口方向直径逐渐减小。
作为本领域技术人员， 对于加强编织网 32的选材可以根据选择不同的材料， 作 为较佳方式增强外管 32可以选择铜丝编织网 （如图 4所示）、或纤维编织网 （如图 5 所示）， 生产工艺通常采用： 三层精密共挤技术： 内层外层同种或者同系高分子材料 比如 PA中间层采用在线编网技术， 另外根据本发明思想， 也可在原料中加入玻璃短 纤维， 一次性挤出成型成外管 3。 三种方式均能到大预期加强效果， 但是， 三种方式 比较而言纤维编织为最佳， 金属丝编织共挤困难， 短纤维无序共挤不能定向增强。
以上所述实施例， 只是本发明的较佳实例， 并非来限制本发明实施范围， 故凡 依本发明申请专利范围所述的构造、 特征及原理所做的等效变化或修饰， 均应包括 于本发明专利申请范围内。

Claims

权利要求书
1、 具有抗扭结外管的球囊扩张导管， 所述球囊扩张导管依次由手柄 (1)、 海波管 (2)、 外管 (3)、 球囊 (4)、 球囊尖端 (5)依次连接而成， 球囊 (4)内设置与外管 (3)及尖端 连接的内管 (6)， 外管 (3)的侧壁上设置导丝口 (31); 其特征在于， 所述外管 (3)的由海 波管 (2)连接端到导丝入口处的管壁层设置增强外管 （32)。
2、 根据权利要求 1所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 外管 (3)和球囊 (4)间连接比外管 (3)细的过渡细管 (7)。
3、 根据权利要求 1所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 海波管 (2)与外管 (3)连接处固定延伸至外管 (3)内的钢丝 (8)。
4、 根据权利要求 3所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 钢丝 (8)由海波管 (2)向导丝进口方向直径逐渐减小。
5、 根据权利要求 1所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 增强外管为金属丝编织层外管。
6、 根据权利要求 1所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 增强外管为纤维编织层外管。
7、 根据权利要求 1所述的具有抗扭结外管的球囊扩张导管， 其特征在于， 所述 增强外管为短纤共挤增强外管。
PCT/CN2011/083956 2011-12-14 2011-12-14 具有抗扭结外管的球囊扩张导管 WO2013086698A1 (zh)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113727750A (zh) * 2019-02-22 2021-11-30 优敦力公司 用于体腔的药物涂布的球囊导管
US12102737B2 (en) 2015-04-24 2024-10-01 Urotronic, Inc. Drug coated balloon catheters for nonvascular strictures
US12115286B2 (en) 2012-10-26 2024-10-15 Urotronic, Inc. Drug-coated balloon catheters for body lumens

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US5879324A (en) * 1997-03-06 1999-03-09 Von Hoffmann; Gerard Low profile catheter shaft
CN1665560A (zh) * 2002-07-03 2005-09-07 奥勃斯医学技术股份有限公司 球囊导管
CN2880013Y (zh) * 2005-12-12 2007-03-21 北京乐普医疗器械有限公司 分叉血管支架的输送器械
CN201370879Y (zh) * 2009-02-25 2009-12-30 赛诺医疗科学技术有限公司 冠状动脉球囊扩张导管
CN102139136A (zh) * 2011-03-11 2011-08-03 微创医疗器械(上海)有限公司 一种球囊扩张导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5879324A (en) * 1997-03-06 1999-03-09 Von Hoffmann; Gerard Low profile catheter shaft
CN1665560A (zh) * 2002-07-03 2005-09-07 奥勃斯医学技术股份有限公司 球囊导管
CN2880013Y (zh) * 2005-12-12 2007-03-21 北京乐普医疗器械有限公司 分叉血管支架的输送器械
CN201370879Y (zh) * 2009-02-25 2009-12-30 赛诺医疗科学技术有限公司 冠状动脉球囊扩张导管
CN102139136A (zh) * 2011-03-11 2011-08-03 微创医疗器械(上海)有限公司 一种球囊扩张导管

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12115286B2 (en) 2012-10-26 2024-10-15 Urotronic, Inc. Drug-coated balloon catheters for body lumens
US12102737B2 (en) 2015-04-24 2024-10-01 Urotronic, Inc. Drug coated balloon catheters for nonvascular strictures
CN113727750A (zh) * 2019-02-22 2021-11-30 优敦力公司 用于体腔的药物涂布的球囊导管

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