WO2014090077A1 - 经桡动脉介入超滑导丝 - Google Patents

经桡动脉介入超滑导丝 Download PDF

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Publication number
WO2014090077A1
WO2014090077A1 PCT/CN2013/087684 CN2013087684W WO2014090077A1 WO 2014090077 A1 WO2014090077 A1 WO 2014090077A1 CN 2013087684 W CN2013087684 W CN 2013087684W WO 2014090077 A1 WO2014090077 A1 WO 2014090077A1
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Prior art keywords
guidewire
wire
core wire
sheath
guide wire
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PCT/CN2013/087684
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English (en)
French (fr)
Inventor
窦克非
仪克晶
刘智勇
张久礼
吕冬
沈辉
郝升旗
Original Assignee
上海微创医疗器械（集团）有限公司
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Publication of WO2014090077A1 publication Critical patent/WO2014090077A1/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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • 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
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip

Definitions

  • the present invention relates to the field of single-use medical devices, and in particular to a coronary interventional diagnosis and treatment operation, in particular, for guiding and locating a catheter in a human body through a radial artery approach.
  • Ultra-smooth guide wire Background technique
  • Percutaneous coronary intervention refers to the diagnosis and treatment of transcatheter coronary artery stenosis and corresponding treatment.
  • the interventional pathway for coronary interventional and therapeutic procedures is mainly divided into the femoral artery and the radial artery.
  • Canadian doctor Campeau pioneered percutaneous transluminal angiography for coronary angiography.
  • Dutch physician Kiemenij reported the results of treatment with this route.
  • coronary interventional diagnosis and treatment coronary artery intervention through the radial artery has been widely used in the clinical diagnosis and treatment of coronary heart disease, with small damage, few local complications, before and after surgery.
  • contrast-guided guidewires are an important instrument for introducing contrast catheters into blood vessels and staying at designated locations.
  • the performance of the guide wire (such as the support of the guide wire, the flexibility of the guide wire, the pushing force of the guide wire, etc.) is an important factor in the smooth progress of the entire interventional procedure.
  • the most common angiographic guidewires on the market today have traditional stainless steel wire guide wires and super-slip guide wires (commonly known as loach guide wires).
  • the stainless steel wire-wound guide wire is in the form of a spiral spring wound core wire, and the head end has no variable diameter, large hardness, poor flexibility, and is difficult to pass a blood vessel with a large curvature.
  • the traditional guide wire has no variable diameter at the head end, and the diameter of the head end is large. The friction of the guide wire with the blood vessel wall during the intervention process is large, the pushing is difficult, and the blood vessel is easily caused.
  • Ultra-smooth guide wire has a good smoothness, which greatly reduces the pushing force of the guide wire and has a very high Strong ability to pass, has been recognized by more and more doctors.
  • the super-slip guide wire does not adopt or partially adopt the spring-wound design of the traditional guide wire, and the surface is covered with a polymer sheath and a hydrophilic coating. The surface is too smooth and the operator feels poor. High smoothness causes loss of tactile feedback, which is likely to cause vascular damage during interventional diagnosis and treatment. Lighter causes hemorrhagic complications such as local hematoma, and severe cases lead to compartment syndrome that endangers the life of the patient. According to statistics, there are currently 5% to 8% of the diagnosis and treatment of bleeding through the radial artery. The bleeding complications are directly or indirectly caused by super-sliding guide wire. The use of super-sliding guide wire increases the risk of surgery and creates unnecessary for the patient. pain.
  • the head end can be divided into a straight type ordinary super-sliding guide wire and a J-type elbow super-sliding guide wire.
  • the former has excellent pass performance, but its surface is too smooth and can easily cause vascular damage during the push process.
  • the latter increases the cushioning due to the bending of the head end, effectively reducing the damage to the blood vessels during the pushing process.
  • the J-shaped guide wire since the head end can not be straightened by pushing and pulling, it is inconvenient to re-enter the catheter, which increases the cumbersome degree of surgery.
  • the performance of the super-sliding guide wire still has obvious defects, and there is much room for improvement.
  • the main disadvantages are: 1) using a polymer sheath to improve the smoothness while reducing other properties of the product, mainly reducing the support of the guide wire And safety, affecting the operator's hand, increasing the risk of vascular injury; 2) J-bend ultra-slip guide wire can reduce the risk of vascular injury, but it is not convenient to re-enter the catheter, increasing the cumbersome degree of surgery. Summary of the invention
  • the present invention is directed to solving one or more of the problems mentioned above, and provides an ultraslip guidewire that has a good overall performance during transradial interventional diagnosis and treatment procedures and that can repeatedly enter a catheter.
  • a guide wire comprising: a core wire located in an inner layer of a guide wire; a wire wound around an intermediate layer of the guide wire and covering the entire core wire, wherein The proximal end of the core wire is connected to the proximal end of the wire, the distal end of the core wire is in a free state, and the sheath is located on the outer layer of the guide wire and covers most of the wire.
  • the guide wire further comprises a safety core wire between the core wire and the wire, the proximal end and the distal end of the safety core wire being respectively connected to the proximal end and the distal end of the wire.
  • the guide wire further comprises a coating applied to the surface of the sheath.
  • the distal end of the core filament tapers.
  • the wire is a coil spring wound wire.
  • the portion of the wire that is not covered by the sheath is located in a portion of the central portion of the guidewire, and the curvature of the distal end region of the guidewire can be manipulated by pushing and pulling the portion of the wire.
  • the portion of the wire that is not covered by the sheath is located in the proximal end region of the guidewire, and the curvature of the distal end region of the guidewire can be manipulated by pushing and pulling the portion of the wire.
  • the safety core wire is flat and is located on one side of the core wire.
  • the core wire is made of Nitinol, stainless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy.
  • the safety core wire is a stainless steel wire.
  • the sheath is a polymeric sheath.
  • the coating is Teflon, PVP, polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, polyaminophthalate, polystyrene, polycarbonate, Silicon tree coating, fluororesin coating or composite coating comprising any combination of the materials.
  • the proximal end of the core wire is welded to the proximal end of the wire.
  • the proximal and distal ends of the safety core are welded together with the proximal and distal ends of the wire, respectively.
  • a guidewire capable of repeatedly entering a catheter comprising:
  • the distal end region of the guide wire is bent to pass the curved passage
  • the invention solves the problems of poor support of the super-sliding guide wire during the transradial interventional diagnosis and treatment, poor haptic feedback, easy vascular damage, inability to easily and repeatedly enter the catheter, and comprehensively improved the angiography.
  • the comprehensive performance of the guide wire DRAWINGS
  • FIG. 1 is a schematic longitudinal cross-sectional view of a guide wire according to an embodiment of the present invention
  • FIG. 2 is a schematic view showing a process of straightening a distal end region of a guide wire from bending;
  • Figure 3 is a schematic view showing the process of straightening the distal end region after the guide wire is withdrawn
  • FIG. 4 is a schematic longitudinal cross-sectional view of a guide wire in accordance with another embodiment of the present invention. detailed description
  • FIG. 1 is a schematic longitudinal cross-sectional view of a guide wire in accordance with an embodiment of the present invention.
  • the guide wire mainly comprises a core wire 1, a wire 2 and a sheath 3. Each of these three sections will be described in detail below.
  • the core wire 1 is located in the inner layer of the guide wire and has a circular cross section or any other suitable shape.
  • the distal end of the core wire 1 is subjected to a variable diameter treatment, preferably tapered, so that the distal end of the guide wire has better flexibility, lowers the distal end hardness, and improves the push performance of the guide wire.
  • the core wire 1 can have good shape memory such as nickel-titanium alloy, stainless steel, Ti-Nb alloy, Ti-Ni-X alloy, Cu-Zn alloy, Cu-Zn-Ni alloy, Fe-Ni alloy or Fe-Mn alloy. The ability to make the material provides good support for the guide wire.
  • the wire 2 is located in the intermediate layer of the guide wire and is preferably a coil spring wound wire.
  • the wire 2 covers the entire core wire 1, the proximal end of the core wire 1 is connected to the proximal end of the wire 2, and the distal end of the core wire 1 is in a free state, covered by the wire 2 but not connected together.
  • the proximal end of the core wire 1 is welded to the proximal end of the wire 2, although other material connections such as bonding, snap fit, etc., may be employed.
  • the sheath 3 is located on the outer layer of the guide wire and uniformly covers most of the wound wire 2. According to the embodiment shown in Fig. 1, except for a partial region in the middle of the guide wire, the other regions are uniformly covered by the sheath 3, that is, the portion of the wound wire 2 that is not covered by the sheath is located in the middle portion of the guide wire. In the sub-area, the curvature of the distal end region of the guide wire can be manipulated by pushing and pulling the partial wire. According to the map
  • the other regions are uniformly covered by the sheath 3, that is, the portion of the wound wire 2 that is not covered by the sheath is located in the proximal end region of the guide wire, by pushing and pulling
  • the partial wire wrap can manipulate the curvature of the distal end region of the guide wire.
  • the sheath 3 is preferably a polymeric sheath, although other suitable materials may be used.
  • the guide wire of the present invention covers the entire guide wire as compared with the conventional super-sliding guide wire, and the polymer sheath is not completely covered.
  • the wire guides the entire guide wire to improve the handling, support and torque transmission of the guide wire, and provides good tactile feedback for better hand feel.
  • the polymer sheath is not completely covered, i.e., the portion is wrapped around the wire, which allows the portion of the wire to be pulled by the push and pull to manipulate the curvature of the distal shaped region of the guidewire. It is clearly shown in Fig. 2 and Fig.
  • the guide wire may further include a safety core wire 5 which is located between the core wire 1 and the wire 2 and is completely covered by the wire 2.
  • the safety core wire 5 is flat and located on one side of the core wire 1, and the two ends of the safety core wire 5 are respectively connected to the proximal end and the distal end of the wire 2, preferably welded Together, it is of course also possible to use other materials such as bonding, snap fit and the like.
  • the safety core wire 5 is annularly located between the core wire 1 and the wire 2 around the core wire 1.
  • the safety core wire 5 provides double protection, avoids the breakage of the wire 2 and remains in the blood vessel, and also transmits the axial tensile force to adjust the curvature of the molded end portion of the guide wire.
  • the safety core wire 5 is preferably a stainless steel wire, although other suitable materials may be used.
  • the guide wire may also include a coating 4 applied to the surface of the sheath 3.
  • Coating 4 may be Teflon, PVP, polyethylene, polypropylene, polyvinyl chloride, polyester, polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicon Resin, fluororesin coating or composite coating comprising any combination of the materials. It is mentioned above that the guide wire according to the present invention can be repeatedly introduced into the catheter during use, which will be described next.
  • the distal end of the guide wire is introduced into the catheter and the guide wire is pushed; then, when necessary, the portion of the wire that is not covered by the sheath is pulled, so that the distal end region of the guide wire is bent to smoothly pass the curved passage;
  • the guidewire is withdrawn; then, by pushing the portion of the wrap that is not covered by the sheath, the distal end region of the guidewire is straightened, thereby facilitating re-entry of the distal end of the guidewire into the catheter.

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Abstract

一种经桡动脉介入超滑导丝，包括：核芯丝（1），其位于导丝的内层；绕丝（2），其位于导丝的中间层并且覆盖整个核芯丝（1）；以及护套（3），其位于导丝的外层并且覆盖绕丝（2）的大部分。其中，核芯丝（1）的近端与绕丝（2）的近端连接，核芯丝（1）的远端处于自由状态。该导丝解决了经桡动脉介入诊断和治疗手术过程中超滑导丝支撑性差，触觉反馈欠佳，容易导致血管损伤和无法便捷地反复进入导管等问题。

Description

经桡动脉介入超滑导丝 技术领域
本发明涉及一次性使用医疗器械领域， 具体地说， 涉及一种用于 冠状动脉介入诊断和治疗手术， 特别是经桡动脉入路时， 实现诊断和 治疗导管在人体内的引导和定位作用的超滑导丝。 背景技术
经皮冠状动脉介入是指经导管诊断冠状动脉狭窄程度并进行相 应处理的诊断和治疗方法。 目前， 冠状动永介入诊断和治疗手术的介 入路径主要分股动脉和桡动脉。 1989年， 加拿大医生 Campeau首创 经皮穿刺桡动脉进行冠状动脉造影， 1992年荷兰医生 Kiemenij报告 了采用此途径进行治疗的结果。 随着冠状动脉介入诊断和治疗手术在 全球范围的推广和普及， 经桡动脉进行冠状动脉介入已被广泛应用于 临床冠心病介入诊断和治疗， 并以其损伤小、 局部并发症少、 手术前 后对抗凝、 抗血小板药物限制小、 术后立即拔管及不必强制卧床 24 小时等更 "微创" 的优点而倍受患者和介入医生的青睐。 目前我国每 年通过桡动脉路径进行冠状动脉介入诊断和治疗手术已经超过 50万 例。
在经皮冠状动脉介入诊断和治疗手术中， 造影导丝是一种重要的 器械， 用于将造影导管导入血管内并停留在指定的位置。 导丝的各项 性能（如： 导丝的支持力、 导丝的柔顺性、 导丝的推送力等）是整个 介入手术顺利进行的重要因素。
目前市场上最常见的造影导丝有传统的不锈钢丝缠绕导丝和超 滑导丝（俗称泥鳅导丝） 。 不锈钢丝缠绕导丝采用螺旋弹簧缠绕芯丝 的形式， 其头端无变径、 硬度较大、 柔顺性差、 不易通过弯曲度较大 的血管。 此外， 传统导丝头端无变径， 还使得其头端直径较大， 导丝 在介入过程中与血管壁摩擦力较大、 推送困难、 易于引起血管痉挛。 超滑导丝因其具有良好的爽滑性， 大大减小了导丝的推送力并具有很 强的通过能力， 获得了越来越多医生的认可。 然而， 超滑导丝物理结 构上不采用或局部采用传统导丝的弹簧绕丝设计， 表面采用聚合物护 套加亲水涂层的结构进行全部覆盖， 其表面过于光滑， 操作者手感欠 佳， 高爽滑性造成了触觉反馈的丟失， 在介入诊断和治疗时容易引起 血管损伤。 轻者引起局部血肿等出血并发症， 重者导致骨筋膜室综合 症危及患者生命。 据统计， 目前有 5%~8%的经桡动脉诊断和治疗手 术出血并发症直接或间接由超滑导丝引起， 超滑导丝的使用增大了手 术风险， 为患者造成了不必要的痛苦。
目前， 市场上常见的超滑导丝中， 按头端形状可分为直型普通超 滑导丝和 J型弯头超滑导丝。 前者有着卓越的通过性能， 但其表面过 于光滑， 在推送的过程中容易导致血管损伤。 后者由于其头端弯曲， 增加了緩冲， 有效减少在推送过程中对血管的损伤。 但是 J型导丝在 使用后，由于不能通过推拉的方式使头端变直，不方便再次进入导管， 增加了手术的繁瑣程度。 综上所述， 目前超滑导丝的性能尚存在明显 缺陷， 具备很大的改进空间。
根据上述心脏介入类超滑导丝的性能的现状， 主要存在的不足 是： 1 ) 使用聚合物护套来提高爽滑性的同时， 降低了产品的其他性 能， 主要是降低了导丝支撑性和安全性， 影响了操作者的手感， 增加 了血管损伤的风险； 2 ) J型弯头超滑导丝虽然能够减少血管损伤的风 险， 但是不方便再次进入导管， 增加了手术的繁瑣程度。 发明内容
本发明旨在解决上述提及的一个或多个问题， 提供一种能够在经 桡动脉介入诊断和治疗手术过程中具有良好综合性能且能反复进入 导管的超滑导丝。
根据本发明的一方面， 提供一种导丝， 包括： 核芯丝， 该核芯丝 位于导丝的内层； 绕丝， 该绕丝位于导丝的中间层并且覆盖整个核芯 丝， 其中， 核芯丝的近端与绕丝的近端连接， 核芯丝的远端处于自由 状态； 以及护套， 该护套位于导丝的外层并且覆盖绕丝的大部分。 优选地， 导丝还包括安全芯丝， 该安全芯丝位于核芯丝和绕丝之 间， 安全芯丝的近端和远端分别与绕丝的近端和远端连接。
优选地， 导丝还包括涂层， 该涂层涂于护套的表面上。
优选地， 核芯丝的远端逐渐变细。
优选地， 绕丝是螺旋弹簧绕丝。
优选地， 绕丝的未被护套覆盖的部分位于导丝中部的部分区域， 通过推拉该部分绕丝能够操控导丝远端区域的弯度。
优选地， 绕丝的未被护套覆盖的部分位于导丝的近端区域， 通过 推拉该部分绕丝能够操控导丝远端区域的弯度。
优选地， 安全芯丝为扁平状且位于核芯丝的一侧。
优选地， 核芯丝采用镍钛合金、 不锈钢、 Ti-Nb合金、 Ti-Ni-X合 金、 Cu-Zn合金、 Cu-Zn-Ni合金、 Fe-Ni合金或 Fe-Mn合金制造。
优选地， 安全芯丝为不锈钢丝。
优选地， 护套为聚合物护套。
优选地， 涂层为特氟龙、 PVP、 聚乙浠、 聚丙浠、 聚氯乙浠、 聚 酯、 聚酰胺、 聚酰亚胺、 聚氨基曱酸酯、 聚苯乙浠、 聚碳酸酯、 硅树 月旨、 氟树脂涂层或包括所述材料任意组合的复合材料涂层。
优选地， 核芯丝的近端与绕丝的近端焊接在一起。
优选地， 安全芯丝的近端和远端分别与绕丝的近端和远端焊接在 一起。
根据本发明的另一方面， 提供一种使用能够反复进入导管的导丝 的方法， 包括：
提供上述导丝；
使导丝的远端进入导管中并推送导丝；
在需要时， 通过拉动所述绕丝的未被护套覆盖的部分， 使得导丝 远端区域弯曲， 以通过弯曲通道；
在操作完成时， 抽出导丝；
通过推动所述绕丝的未被护套覆盖的部分，使得导丝远端区域变 直， 从而使得导丝的远端能够再次进入导管。 与现有技术相比， 本发明解决了经桡动脉介入诊断和治疗手术过 程中超滑导丝支撑性差、 触觉反馈欠佳、 容易导致血管损伤、 无法便 捷地反复进入导管等问题， 全面提高了造影导丝的综合性能。 附图说明
图 1是根据本发明的一种实施方式的导丝的纵截面示意图； 图 2是导丝的远端区域从弯曲变直的过程示意图；
图 3是导丝被抽出后其远端区域变直过程示意图； 以及
图 4是根据本发明的另一种实施方式的导丝的纵截面示意图。 具体实施方式
在本说明书中， 同样的附图标记用来表示同样的组成部分。
图 1是根据本发明的一种实施方式的导丝的纵截面示意图。 参照 图 1， 导丝主要包括核芯丝 1、 绕丝 2和护套 3。 下面将针对这三个部 分中的每一个进行详细说明。
核芯丝 1位于导丝的内层， 其横截面呈圆形或任何其它适当的形 状。 核芯丝 1的远端采用变径处理， 优选为逐渐变细， 这样可以使导 丝的远端具有更好的柔顺性、 降低远端硬度并提高导丝的推送性能。 核芯丝 1 可以采用镍钛合金、 不锈钢、 Ti-Nb合金、 Ti-Ni-X合金、 Cu-Zn合金、 Cu-Zn-Ni合金、 Fe-Ni合金或 Fe-Mn合金等具有良好形 状记忆能力的材料制成， 从而为导丝提供良好的支持力。
绕丝 2位于导丝的中间层， 并且优选为螺旋弹簧绕丝。 绕丝 2覆 盖整个核芯丝 1， 核芯丝 1的近端与绕丝 2的近端连接在一起， 而核 芯丝 1的远端处于自由状态，被绕丝 2包覆但不连接在一起。优选地， 核芯丝 1的近端与绕丝 2的近端焊接连接，当然也可以采用例如粘合、 卡扣配合等其它材料连接方式。
护套 3位于导丝的外层并且均匀地覆盖绕丝 2的大部分。根据图 1所示的实施方式， 除导丝中部的部分区域外， 其它区域由护套 3均 匀覆盖， 也就是说， 绕丝 2的未被护套覆盖的部分位于导丝中部的部 分区域， 通过推拉该部分绕丝能够操控导丝远端区域的弯度。 根据图
4所示的实施方式， 除导丝的近端区域外， 其它区域由护套 3均匀覆 盖， 也就是说， 绕丝 2的未被护套覆盖的部分位于导丝的近端区域， 通过推拉该部分绕丝能够操控导丝远端区域的弯度。 本领域技术人员 还应当理解， 绕丝 2的棵露部分可以根据医生的不同操作习惯进行选 择， 而不限于上述两种实施方式。 护套 3优选为聚合物护套， 当然也 可以采用其它适当的材料。
根据上述导丝的结构， 与传统超滑导丝相比， 本发明的导丝的绕 丝覆盖了整根导丝， 而聚合物护套没有完全覆盖。 绕丝覆盖整根导丝 用以提高导丝的操控性、 支撑性以及扭矩传递性能， 并能够提供良好 的触觉反馈使得手感更佳。 聚合物护套没有完全覆盖， 也就是说， 部 分绕丝棵露在外面， 这使得可以通过推拉拉动该部分绕丝来操控导丝 远端塑型区域的弯度。 图 2和图 3中清楚地显示了通过推拉拉动棵露 的绕丝部分来调整导丝远端塑型区域的弯曲程度， 方便导丝多次进入 导管， 这样就很好地解决了弯头超滑导丝远端不易被拉直， 增加手术 繁瑣程度的问题。
接下来继续参照图 1， 除了上面提及的三个部分外， 导丝还可以 包括安全芯丝 5， 其位于核芯丝 1和绕丝 2之间，被绕丝 2完全覆盖。 根据图 1所示的实施方式， 安全芯丝 5为扁平状且位于核芯丝 1的一 侧， 安全芯丝 5的两端分别与绕丝 2的近端和远端连接， 优选为焊接 在一起， 当然也可以采用粘合、卡扣配合等其它材料连接方式。此外， 本领域技术人员可以想到， 安全芯丝 5环绕核芯丝 1呈环形地位于核 芯丝 1和绕丝 2之间。 安全芯丝 5能够提供双重保护， 避免绕丝 2断 裂而遗留在血管中， 还能传导轴向拉伸力， 调整导丝头端塑型区域的 弯度。安全芯丝 5优选为不锈钢丝， 当然也可以采用其它适当的材料。
导丝还可以包括涂在护套 3的表面上的涂层 4。 涂层 4可以是特 氟龙、 PVP、 聚乙浠、 聚丙浠、 聚氯乙浠、 聚酯、 聚酰胺、 聚酰亚胺、 聚氨基曱酸酯、 聚苯乙浠、 聚碳酸酯、 硅树脂、 氟树脂涂层或包括所 述材料任意组合的复合材料涂层。 上面提到根据本发明的导丝在使用时能够反复进入导管，接下来 将对此进行说明。 首先，使导丝的远端进入导管中并推送导丝；接着， 在需要时， 通过拉动绕丝的未被护套覆盖的部分， 使得导丝远端区域 弯曲， 以顺利通过弯曲通道； 在操作完成时， 抽出导丝； 然后， 通过 推动绕丝的未被护套覆盖的部分， 使得导丝远端区域变直， 从而有利 于导丝的远端再次进入导管中。
本领域技术人员显然清楚， 可对所公开的实施方式作出各种修改 和变型而不脱离本发明的范围。基于本说明书和对本文所公开内容的 实践， 本领域技术人员还可以想到其它实施方式。 本说明书和示例应 被看作仅仅是示例性的， 而本发明的真正范围由所附权利要求及其等 同物指明。

Claims

权利要求书
1. 一种导丝， 包括：
核芯丝， 所述核芯丝位于导丝的内层；
绕丝， 所述绕丝位于导丝的中间层并且覆盖整个核芯丝， 其中， 所述核芯丝的近端与绕丝的近端连接， 所述核芯丝的远端处于自由状 态； 以及
护套， 所述护套位于导丝的外层并且覆盖所述绕丝的大部分。
2. 根据权利要求 1所述的导丝， 还包括安全芯丝， 所述安全芯丝 位于所述核芯丝和绕丝之间， 所述安全芯丝的近端和远端分别与所述 绕丝的近端和远端连接。
3. 根据权利要求 1或 2所述的导丝，还包括涂层， 所述涂层涂于 所述护套的表面上。
4. 根据权利要求 1所述的导丝， 其中， 所述核芯丝的远端逐渐变 细。
5. 根据权利要求 1所述的导丝，其中，所述绕丝是螺旋弹簧绕丝。
6. 根据权利要求 1所述的导丝， 其中， 所述绕丝的未被护套覆盖 的部分位于导丝中部的部分区域， 通过推拉该部分绕丝能够操控导丝 远端区域的弯度。
7. 根据权利要求 1所述的导丝， 其中， 所述绕丝的未被护套覆盖 的部分位于导丝的近端区域， 通过推拉该部分绕丝能够操控导丝远端 区域的弯度。
8. 根据权利要求 2所述的导丝， 其中， 所述安全芯丝为扁平状且 位于核芯丝的一侧。
9. 根据权利要求 1所述的导丝，其中，所述核芯丝采用镍钛合金、 不锈钢、 Ti-Nb合金、 Ti-Ni-X合金、 Cu-Zn合金、 Cu-Zn-Ni合金、 Fe-Ni合金或 Fe-Mn合金制造。
10. 根据权利要求 2所述的导丝， 其中， 所述安全芯丝为不锈钢
11. 根据权利要求 1所述的导丝， 其中， 所述护套为聚合物护套。
12. 根据权利要求 3所述的导丝，其中，所述涂层为特氟龙、 PVP、 聚乙浠、 聚丙浠、 聚氯乙浠、 聚酯、 聚酰胺、 聚酰亚胺、 聚氨基曱酸 酉 、 聚苯乙浠、 聚碳酸酯、 硅树脂、 氟树脂涂层或包括所述材料任意 组合的复合材料涂层。
13. 根据权利要求 1所述的导丝， 其中， 所述核芯丝的近端与绕 丝的近端焊接在一起。
14. 根据权利要求 2所述的导丝， 其中， 所述安全芯丝的近端和 远端分别与所述绕丝的近端和远端焊接在一起。
15. 一种使用能够反复进入导管的导丝的方法， 包括：
提供根据独立权利要求 1所述的导丝；
使导丝的远端进入导管中并推送导丝；
在需要时， 通过拉动所述绕丝的未被护套覆盖的部分， 使得导丝 远端区域弯曲， 以通过弯曲通道；
在操作完成时， 抽出导丝；
通过推动所述绕丝的未被护套覆盖的部分，使得导丝远端区域变 直， 从而使得导丝的远端能够再次进入导管。
PCT/CN2013/087684 2012-12-14 2013-11-22 经桡动脉介入超滑导丝 WO2014090077A1 (zh)

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