CN112439121A - 一种非顺应性pta球囊扩张导管 - Google Patents

一种非顺应性pta球囊扩张导管 Download PDF

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CN112439121A
CN112439121A CN201910794762.6A CN201910794762A CN112439121A CN 112439121 A CN112439121 A CN 112439121A CN 201910794762 A CN201910794762 A CN 201910794762A CN 112439121 A CN112439121 A CN 112439121A
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catheter
cavity
balloon
tube
pta
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李京龙
赵丽晓
张昱昕
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Lepu Medical Technology Beijing Co Ltd
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Lepu Medical Technology Beijing Co Ltd
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    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0071—Multiple separate lumens
    • 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
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • 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
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • 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
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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

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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)
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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

本发明公开一种非顺应性PTA球囊扩张导管，包括球囊、外管、内管、管座、标记环和尖端。非顺应性PTA球囊扩张导管为经皮腔内周边血管成型术用血管内导管，结构为同轴型(OTW)球囊扩张导管。OTW型导管的推送力和通过性较好，无需指引导管提供支持。管座与外管双腔结构的两个通道相连，一个是导丝腔，即导丝进入导管内腔(中心腔)的通道，另一个是充盈腔，用于输送造影剂与生理盐水混合液体进而扩张导管远端的球囊的通道。内管上附有标记环，借助X射线显影，进而准确扩张靶病变部位。锥状的尖端有利于通过堵塞狭窄的病变区域，减少导管对血管的损伤。双层球囊的结构设计能保证球囊高耐压性的同时，具有较高的柔顺性和通过性。

Description

一种非顺应性PTA球囊扩张导管
技术领域
本发明涉及一种非顺应性PTA球囊扩张导管，是一种血管内介入器械，通过加压球囊，扩张狭窄病变，改善血流通量。
技术背景
经皮腔内血管成形术(PTA)是指采用经皮穿刺技术将球囊扩张导管插入血管狭窄部位，在医学成像设备引导和监控下加压球囊，通过机械扩张，使血管内粥样斑块或血栓发生变形、撕裂、挤碎、血管本身扩张等，从而改变血管形态，实现血运重建。
外周血管病变，特别是血液透析患者的动静脉瘘狭窄，由于患者反复穿刺造成血管内膜过度增生，狭窄部位斑块致密坚硬，需要使用耐高压的非顺应性PTA球囊导管进行扩张。
非顺应性PTA球囊扩张导管为经皮腔内周边血管成型术用血管内导管，结构为同轴型(OTW)球囊扩张导管。OTW型导管的推送力较好，无需指引导管提供支持。通常采用非顺应性的囊体材质和增加球囊壁厚的手段使球囊耐压性能提高，但往往会导致球囊的柔顺性和通过性变差。
发明内容
本发明的目的在于克服现有产品的不足，提供一种兼顾耐压性和柔顺性的非顺应性PTA球囊扩张导管。
为实现上述目的，本发明所采用以下的技术方案：
本发明中的非顺应性PTA球囊扩张导管，包括球囊、外管、内管、管座、标记环和尖端。外管为双腔结构，分别与管座的双腔连通，作为导丝通过的导丝腔和液体充盈的充盈腔。球囊内的内管作为导丝通过的导丝腔。内管上附有显影定位的标记环。球囊外的尖端呈圆锥状，有利于通过堵塞狭窄的病变区域，并减少导管对血管的损伤。球囊为双层结构，外层为无定型态的尼龙，内层为半结晶态的PEBAX，这种结构保证球囊高耐压性的同时，使球囊具有很好的柔顺性和通过性。
本发明中的外管为共挤出的双腔结构或嵌套的双腔结构。
本发明中的内管上附有标记环，标记环为铂、铱、金等金属或合金。
本发明中的尖端呈光滑的圆锥状。
球囊为双层结构，外层为邵氏硬度＞77D的无定型态的尼龙，如PA11，PA12等，内层半结晶态，邵氏硬度＜73D,如PEBAX 72D/70D/63D/55D。
本发明的有益效果如下：双层球囊的结构特点克服了球囊柔顺性和通过性差的问题。球囊的材料设计兼顾了强度、柔顺性和顺应性等。外层为无定型态(玻璃化转变温度Tg)，内层为半结晶态(熔点Tm)，Tg＜Tm，球囊在吹塑过程中，外层发生热力学松弛，降低了内层径向撕裂的程度，保证了球囊的耐压性。同时，低壁厚的设计保证了较好的柔顺性和通过性。
附图说明
图1为本发明的结构示意图
图2位图1的A部位的局部剖视放大图
图3位图1的B部位的局部剖视放大图
具体实施方式
实施例1：如图1所示，本发明中的非顺应性PTA球囊扩张导管，包括球囊、外管、内管、管座、标记环和尖端。外管为共挤出的双腔管，分别与管座的双腔连通，作为导丝通过的导丝腔和液体充盈的充盈腔。球囊内的内管作为导丝通过的导丝腔。内管附着的标记环为铂铱合金(铂：铱＝9:1)。球囊外的尖端呈圆锥状。球囊为双层结构，外层为Grilamid TR55，内层为PEBAX 70D。
实施例2：如图1所示，本发明中的非顺应性PTA球囊扩张导管，包括球囊、外管、内管、管座、标记环和尖端。外管为嵌套的双腔管，分别与管座的双腔连通，作为导丝通过的导丝腔和液体充盈的充盈腔。球囊内的内管作为导丝通过的导丝腔。内管附着的标记环为金。球囊外的尖端呈圆锥状。球囊为双层结构，外层为PA12，内层为PEBAX 72D。
本发明不局限与上述实施方式，任何人在本发明的启示下可得出其他各种形式的产品，但不论在其形状或结构上作任何变化，凡是具有与本申请相同或者相近的技术方案，均落在本发明的保护范围之内。

Claims (5)

1.一种非顺应性PTA球囊扩张导管，其特征在于，包括球囊(1)、外管(2)、内管(3)、管座(4)和标记环(5)和尖端(6)。外管(2)为双腔结构，分别与管座(4)的双腔连通，作为导丝通过的导丝腔(7)和液体充盈的充盈腔(8)。球囊内的内管(3)作为导丝通过的导丝腔(7)。内管(7)上附有显影定位的标记环(5)。球囊外的尖端(6)呈圆锥状，有利于通过堵塞狭窄的病变区域，并减少导管对血管的损伤。球囊(1)为双层结构，外层为无定型态的尼龙，内层为半结晶态的PEBAX，这种结构保证球囊高耐压性的同时，使球囊具有很好的柔顺性和通过性。
2.根据权利要求1中所述的一种非顺应性PTA球囊扩张导管，其特征在于，外管为共挤出的双腔结构(图2.a)或嵌套的双腔结构(图2.b)。
3.根据权利要求1中所述的一种非顺应性PTA球囊扩张导管，其特征在于，内管上附有标记环，标记环为铂、铱、金等金属或合金。
4.根据权利要求1中所述的一种非顺应性PTA球囊扩张导管，其特征在于，尖端呈光滑的圆锥状。
5.根据权利要求1中所述的一种非顺应性PTA球囊扩张导管，其特征在于，球囊为双层结构，外层为邵氏硬度＞77D的无定型态的尼龙，如PA11，PA12等，内层半结晶态，邵氏硬度＜73D,如PEBAX 72D/70D/63D/55D。
CN201910794762.6A 2019-08-27 2019-08-27 一种非顺应性pta球囊扩张导管 Pending CN112439121A (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114939224A (zh) * 2022-06-02 2022-08-26 上海畅德医疗科技有限公司 一种高压药物球囊扩张导管及其制备方法和应用

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201182828Y (zh) * 2008-04-21 2009-01-21 乐普（北京）医疗器械股份有限公司 一种用于扩张管腔的球囊扩张导管
CN102186509A (zh) * 2008-09-03 2011-09-14 波士顿科学国际有限公司 多层医用球囊
CN103282075A (zh) * 2010-09-17 2013-09-04 雅培心血管系统有限公司 长度和直径可调整的球囊导管
CN104955515A (zh) * 2012-11-19 2015-09-30 雅培心血管系统有限公司 用于导管的多层球囊
CN106390268A (zh) * 2016-10-21 2017-02-15 复旦大学附属中山医院 一种可扩张可灌注的球囊导管
CN107802944A (zh) * 2017-06-01 2018-03-16 刘逸 一种定向挤压球囊扩张导管

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201182828Y (zh) * 2008-04-21 2009-01-21 乐普（北京）医疗器械股份有限公司 一种用于扩张管腔的球囊扩张导管
CN102186509A (zh) * 2008-09-03 2011-09-14 波士顿科学国际有限公司 多层医用球囊
CN103282075A (zh) * 2010-09-17 2013-09-04 雅培心血管系统有限公司 长度和直径可调整的球囊导管
CN104955515A (zh) * 2012-11-19 2015-09-30 雅培心血管系统有限公司 用于导管的多层球囊
CN106390268A (zh) * 2016-10-21 2017-02-15 复旦大学附属中山医院 一种可扩张可灌注的球囊导管
CN107802944A (zh) * 2017-06-01 2018-03-16 刘逸 一种定向挤压球囊扩张导管

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114939224A (zh) * 2022-06-02 2022-08-26 上海畅德医疗科技有限公司 一种高压药物球囊扩张导管及其制备方法和应用

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Application publication date: 20210305