WO2013086700A1 - 设置软质包覆尖端的球囊扩张导管 - Google Patents

设置软质包覆尖端的球囊扩张导管 Download PDF

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Publication number
WO2013086700A1
WO2013086700A1 PCT/CN2011/083961 CN2011083961W WO2013086700A1 WO 2013086700 A1 WO2013086700 A1 WO 2013086700A1 CN 2011083961 W CN2011083961 W CN 2011083961W WO 2013086700 A1 WO2013086700 A1 WO 2013086700A1
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Prior art keywords
balloon
tip
catheter
soft
coating
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Application number
PCT/CN2011/083961
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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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Application filed by 东莞市迪凯精密管材有限公司 filed Critical 东莞市迪凯精密管材有限公司
Priority to US13/809,160 priority Critical patent/US9199068B2/en
Priority to PCT/CN2011/083961 priority patent/WO2013086700A1/zh
Priority to EP11868858.9A priority patent/EP2626102B1/en
Priority to CN201180042692.0A priority patent/CN104185491B/zh
Publication of WO2013086700A1 publication Critical patent/WO2013086700A1/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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008—Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081—Soft tip
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1093—Balloon catheters with special features or adapted for special applications having particular tip characteristics
    • 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
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated

Definitions

  • the present invention relates to the field of cardiac medical device technology, and more particularly to a balloon-expanding catheter provided with a soft coated tip. Background technique
  • a balloon dilatation catheter is also rapidly updated with the continuous advancement of technology.
  • the PTCA procedure generally includes transdermal
  • the punctured guide catheter is advanced within the femoral or cutaneous artery.
  • the distal end of the guiding catheter has been placed at the entrance of the coronary artery.
  • a balloon dilation catheter is passed through the guiding catheter.
  • the balloon dilatation catheter is typically used with a small diameter steerable guide wire that can be manipulated into the selected arterial branch to be treated, and then the balloon dilatation catheter in a collapsed state.
  • the guide wire with the anastomosis is pushed into the stenosis area, and finally the balloon 1 is inflated for the stenosis of the stenosis to achieve therapeutic purposes.
  • the catheter tip 3 in the existing PTCA balloon dilatation catheter currently on the market is generally directly welded with the inner tube 2 and the catheter tip 3 tube, and the structure of the balloon 1 extension 11 is welded and welded together at the junction ( As shown in Figure 1, due to the choice of materials, the current tip includes two types, one is a soft tip and the other is a hard tip.
  • the benefits of soft tip are softness and low trauma to blood vessels; the tip is attached to the guide wire, and it is flexible and effective to increase the flexibility of the catheter. It is currently the leading material.
  • the shortcomings are obvious during use.
  • the inner tube and the tip material are made of soft material. Even if the inside of the tube and the guide wire have a lubricating coating, the soft material has elasticity and has strong coating property.
  • the present invention is directed to the problem of presenting a dead guide wire at the tip of a current PTCA balloon expandable catheter and causing re-injury to the patient, and a balloon-expandable catheter provided with a soft-coated tip to solve the above problems.
  • a soft coated tip balloon dilatation catheter comprising a balloon, an inner tube, a ball
  • the end of the balloon extends toward the outer end of the end of the tube to form a tapered catheter tip having a soft tip coating over the balloon tip.
  • the tip coating is applied to the end face of the catheter tip, and the outer edge of the end of the coating is rounded.
  • the wall of the end section of the inner tube is gradually thinned toward the tip end and forms a joint with no obvious step position with the outer end of the balloon end.
  • the wall of the catheter tip formed by the distal end of the balloon is gradually thinned, the outer wall of the coating layer is gradually thickened, and the wall thickness of the balloon end extension and the coating layer is uniform.
  • the binding position is smooth and smooth.
  • the material hardness of the end portion of the balloon is in the range of 55-90 Shore hardness; the hardness of the coating material ranges from 30 to 55 Shore hardness.
  • a balloon-expanding catheter with a soft-coated tip of the present invention a balloon-expanding catheter with a soft-coated tip
  • the balloon-expanding catheter including a balloon, an inner tube, and a balloon a tip end of the catheter extending toward the outer end of the inner tube to form a tapered lumen, and a tip coating on the tip of the catheter is coated with a softer material than the balloon material
  • the balloon material is generally made of a hard material, from the end of the balloon Extending to form the tip of the catheter, the inner cavity material is hard, so the higher hardness of the inner tip layer plus the inner hydrophilic coating can effectively reduce the locking of the guide wire, ensure smooth operation and reduce medical accidents
  • Covering the tip coating that is softer than the balloon material the damage to the vessel wall during tip contact with the vessel wall is minimized during surgery and does not cause re-injury to the patient's cardiovascular system.
  • FIG. 1 is a schematic view showing the structure of a prior art balloon dilatation catheter
  • Fig. 3 is a partially enlarged schematic view showing a portion A in Fig. 2. detailed description
  • a soft-coated tip balloon dilatation catheter comprising a balloon 1, an inner tube 2, a balloon tip 1 end of the catheter tube 3 extending toward the outer end of the end of the tube 2 to form a tapered lumen a tip coating 4 that is softer than the material of the balloon 1 is applied over the catheter tip 3; as a preferred embodiment, the material and coating of the balloon 1 are selected on the material.
  • the material of the layer is generally selected from the same material to facilitate the tightness and stability of the heat welding between them;
  • the material of the balloon 1 is generally selected from PA, PE, EVA or alloy materials with a hardness range of 55-90 Shore;
  • the hardness of the coating material ranges from PA to PA polyether alloy materials with a Shore hardness of 30 to 55.
  • the tip coating 4 is applied to the end face 31 of the catheter tip 3, and the outer edge of the end of the coating 4 is provided with a rounded corner 41.
  • the rounded corner 41 minimizes damage to the blood vessel during surgery.
  • the tube wall of the end section of the inner tube 2 is gradually thinned toward the tip end and forms a joint with no obvious step position with the end portion of the balloon 1 end.
  • the wall of the catheter tip 3 formed outwardly at the end of the balloon 1 is gradually thinned, the outer wall of the coating layer 4 is gradually thickened, and the tube end portion of the balloon 1 and the tube formed by the coating layer 4 are gradually thickened.
  • the wall thickness is uniform, forming a smooth and smooth composite tube wall for easy surgical operation.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (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)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种设置软质包覆尖端的球囊扩张导管，属于心脏医疗器械技术领域。上述球囊扩张导管包括有球囊（1）、内管（2），球囊（1）远端在内管（2）终端向外端延伸形成锥形内腔的导管尖端（3），在导管尖端（3）上披覆较球囊材料软的尖端包覆层（4）；球囊（1）材料一般选用材质较硬的材料，由球囊（1）远端延伸形成导管尖端（3），内腔材质较硬，因此硬度较高的尖端内层加上内层亲水涂层可以有效的减少导丝抱死现象，保证手术顺畅进行，减少医疗事故发生；外层披覆较球囊（1）材料软的尖端包覆层（4），在手术过程中，尖端在接触血管壁时对血管壁的损伤减少到最小，不会对患者的心血管造成再次损害。

Description

设置软质包覆尖端的球囊扩张导管
技术领域
本发明涉及心脏医疗器械技术领域， 尤其是指设置软质包覆尖端的球囊扩张导 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， 该 PTCA程序一般 包括使经皮肤穿刺的导引导管在股动脉或肤动脉内推进已将该导引导管的远侧端部 放置在冠状动脉进口处， 把导引导管定位后， 将一个球囊扩张导管穿过导引导管进 入冠状动脉内， 该球囊扩张导管一般与一个小直径可操纵的导引钢丝一起使用， 该 导引钢丝可被操作而进入待治疗的所选择的动脉支脉， 然后縮坍状态的球囊扩张导 管与吻合的导引钢丝被推送进入狭窄区， 最后使球囊 1 冲胀以便狭窄动脉扩张， 以 达到治疗目的。
目前市场上现有的 PTCA球囊扩张导管中的导管尖端 3普遍采用内管 2与导管 尖端 3管直接焊接，在两者连接处由球囊 1延伸段 11覆盖并将其焊接一起的结构（如 图 1所示）， 由于材料的选用， 目前的尖端包括两类， 一类是软尖端， 一类是较硬尖 端。 软尖端的好处是柔软度好， 对血管的创伤小； 尖端对导丝的贴附好， 能灵活有 效的提高导管的灵活性， 是目前主要的尖端材料。 在使用过程中其缺点也很明显， 内管以及尖端的材料都选用了软材质， 即使导管内部以及导丝都有润滑涂层， 但是 软性材料存在弹性具有较强的包覆性， 容易在导管拐弯受力较大的情况下抱死导丝， 导丝不能自由转动， 常常导致手术无法正常进行； 采用较硬尖端的， 最大的缺点是 容易对血管组织造成损伤， 引发对患者的心血管的再次伤害。 发明内容
本发明在于针对目前 PTCA球囊扩展导管的尖端存在抱死导丝以及对患者造成 再次伤害的问题， 而提供解决以上问题的设置软质包覆尖端的球囊扩张导管。
为达到上述目的， 本发明采用如下技术方案：
设置软质包覆尖端的球囊扩张导管， 所述球囊扩张导管包括有球囊、 内管， 球 囊末端在内管终端向外端延伸形成锥形内腔的导管尖端， 在导管尖端上披覆较球囊 材料软的尖端包覆层。
其中所述尖端包覆层包覆到导管尖端的末端面， 包覆层末端的外沿设置圆角位。 其中所述内管终端段的管壁向尖端方向逐渐变薄并与球囊末端向外端延伸段形 成无明显台阶位结合。
其中所述球囊末端向外延伸形成的导管尖端的管壁逐渐变薄， 所述包覆层向外 的管壁逐渐增厚， 球囊末端延伸段与包覆层所构成的管壁厚度均匀， 结合位顺畅平 滑。
其中所述球囊末端延伸段的材料硬度范围为 55-90邵氏硬度；所述包覆层材料的 硬度范围为： 30~55邵氏硬度。
本发明的有益效果在于： 本发明的设置软质包覆尖端的球囊扩张导管， 设置软 质包覆尖端的球囊扩张导管， 所述球囊扩张导管包括有球囊、 内管， 球囊末端在内 管终端向外端延伸形成锥形内腔的导管尖端， 在导管尖端上披覆较球囊材料软的尖 端包覆层； 球囊材料一般选用材质较硬的材料， 由球囊末端延伸形成导管尖端， 内 腔材质较硬， 因此硬度较高的尖端内层加上内层亲水涂层可以有效的减少对导丝抱 死现象， 保证手术顺畅进行， 减少医疗事故发生； 外层披覆较球囊材料软的尖端包 覆层， 在手术过程中， 尖端在接触血管壁时对血管壁的损伤减少到最小， 不会对对 患者的心血管的造成再次伤害。 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。 具体实施方式
下面结合附图 2、 3本发明作进一步阐述：
设置软质包覆尖端的球囊扩张导管， 所述球囊扩张导管包括有球囊 1、 内管 2， 球囊 1末端在内管 2终端向外端延伸形成锥形内腔的导管尖端 3，在导管尖端 3上披 覆较球囊 1材料软的尖端包覆层 4; 作为较佳实施方式，在选材上球囊 1材料和披覆 层材料时一般选用同系材料， 便于他们之间热焊接的紧密性和稳定牢固性； 球囊 1 材料一般选用硬度范围为邵氏硬度 55-90的 PA、 PE、 EVA或者它们的合金材料； 披 覆层材料的硬度范围为邵氏硬度 30~55的 PA、 PA聚醚合金材料。
尖端包覆层 4包覆到导管尖端 3的末端面 31， 包覆层 4末端的外沿设置圆角位 41， 圆角位 41可以最大程度上减少手术过程中对血管造成的损伤。 在内管 2终端段 的管壁向尖端方向逐渐变薄并与球囊 1末端向外端延伸段形成无明显台阶位结合。
在球囊 1末端向外延伸形成的导管尖端 3的管壁逐渐变薄， 所述包覆层 4向外 的管壁逐渐增厚， 球囊 1末端延伸段与包覆层 4所构成的管壁厚度均匀， 形成结合 位顺畅平滑的复合管壁， 便于手术操作。
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、 设置软质包覆尖端的球囊扩张导管， 所述球囊扩张导管包括有球囊 (1)、 内管 (2),其特征在于，球囊 (1)末端在内管 (2)终端向外端延伸形成锥形内腔的导管尖端 (3)， 在导管尖端 (3)上披覆较球囊 (1)材料软的尖端包覆层 (4)。
2、 根据权利要求 1所述的设置软质包覆尖端的球囊扩张导管， 其特征在于， 所 述尖端包覆层 (4)包覆到导管尖端 (3)的末端面 (31)， 包覆层 (4)末端的外沿设置圆角位 (41)。
3、 根据权利要求 1所述的设置软质包覆尖端的球囊扩张导管， 其特征在于， 所 述内管 (2)终端段的管壁向尖端方向逐渐变薄， 并与球囊 (1)末端向外端延伸段形成无 明显台阶位结合。
4、 根据权利要求 1所述的设置软质包覆尖端的球囊扩张导管， 其特征在于， 所 述球囊 (1)末端向外延伸形成的导管尖端 (3)的管壁逐渐变薄， 所述包覆层 (4)向外的管 壁逐渐增厚， 球囊 (1)末端延伸段与包覆层 (4)所构成的管壁厚度均匀， 结合位顺畅平 滑。
5、 根据权利要求 1所述的设置软质包覆尖端的球囊扩张导管， 其特征在于， 所 述球囊 (1)末端延伸段的材料硬度范围为 55-90邵氏硬度； 所述包覆层 (4)材料的硬度 范围为： 30~55邵氏硬度。
PCT/CN2011/083961 2011-12-14 2011-12-14 设置软质包覆尖端的球囊扩张导管 WO2013086700A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US13/809,160 US9199068B2 (en) 2011-12-14 2011-12-14 Balloon dilatation catheter provided with soft coating
PCT/CN2011/083961 WO2013086700A1 (zh) 2011-12-14 2011-12-14 设置软质包覆尖端的球囊扩张导管
EP11868858.9A EP2626102B1 (en) 2011-12-14 2011-12-14 Balloon dilatation catheter provided with soft cladding tip
CN201180042692.0A CN104185491B (zh) 2011-12-14 2011-12-14 设置软质包覆尖端的球囊扩张导管

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2011/083961 WO2013086700A1 (zh) 2011-12-14 2011-12-14 设置软质包覆尖端的球囊扩张导管

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US (1) US9199068B2 (zh)
EP (1) EP2626102B1 (zh)
CN (1) CN104185491B (zh)
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Publication number Priority date Publication date Assignee Title
CN106994203A (zh) * 2016-01-22 2017-08-01 上海微创医疗器械（集团）有限公司 导引导管及其制备方法
GB2565843B (en) * 2017-08-25 2019-09-25 Strait Access Tech Holdings Pty Ltd Invaginating device
CN111467649B (zh) * 2020-05-27 2022-03-29 深圳北芯生命科技股份有限公司 微导管
CN115414574B (zh) * 2022-08-17 2023-04-07 广东博迈医疗科技股份有限公司 一种导管尖端、球囊导管及血管介入装置

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US20130158590A1 (en) 2013-06-20
EP2626102B1 (en) 2017-08-16
CN104185491B (zh) 2016-08-10
EP2626102A4 (en) 2014-02-19
US9199068B2 (en) 2015-12-01
CN104185491A (zh) 2014-12-03
EP2626102A1 (en) 2013-08-14

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