WO2013056672A1 - 肾动脉射频消融导管 - Google Patents

肾动脉射频消融导管 Download PDF

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Publication number
WO2013056672A1
WO2013056672A1 PCT/CN2012/083207 CN2012083207W WO2013056672A1 WO 2013056672 A1 WO2013056672 A1 WO 2013056672A1 CN 2012083207 W CN2012083207 W CN 2012083207W WO 2013056672 A1 WO2013056672 A1 WO 2013056672A1
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WIPO (PCT)
Prior art keywords
catheter
section
segment
bendable
electrode
Prior art date
Application number
PCT/CN2012/083207
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English (en)
French (fr)
Inventor
郭俊敏
杨谦谦
朱福音
张国旺
高宾
梁波
孙毅勇
罗七一
Original Assignee
上海微创电生理医疗科技有限公司
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Publication of WO2013056672A1 publication Critical patent/WO2013056672A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation

Definitions

  • the present invention relates generally to medical catheters, and more particularly to a catheter that is simple, rapid, and safe for use in intravascular ablation of the renal artery. Background technique
  • Hypertension has the characteristics of high incidence, low awareness rate and high harm.
  • the "Guidelines for the Prevention and Treatment of Hypertension in China" pointed out that China has 10 million new hypertensive patients each year. In 2006, the number has reached 200 million, of which 20% are patients with refractory hypertension.
  • Refractory hypertension also known as refractory hypertension, refers to high blood pressure that cannot be effectively controlled after treatment with lifestyle improvements and three or more antihypertensive drugs, including a diuretic.
  • Experimental data have shown that hypertension is associated with high renal sympathetic excitability in patients. Blocking the renal sympathetic nerves not only reduces blood pressure, but also affects chronic organ-specific diseases caused by excessive sympathetic activation.
  • Blocking the renal sympathetic nerves also improves left ventricular hypertrophy and insulin resistance.
  • the latest animal and clinical follow-up 2 years of experimental data show that renal sympathetic radiofrequency ablation with percutaneous catheter can significantly and permanently reduce refractory hypertension.
  • the procedure uses RF energy to perform impedance heating on the sympathetic nerves in the renal artery, which can attenuate the sympathetic activity of the renal artery and even lose its conduction function.
  • This method can not only effectively treat refractory hypertension, but also has the advantages of minimally invasive and less complications.
  • This approach is seen as a breakthrough and opens up new avenues for the treatment of refractory hypertension.
  • Cisode CN201469401U proposes a spiral ring kidney movement
  • a sympathomimetic radiofrequency ablation lead catheter that forms a non-circular closed continuous contact ablation along the renal artery.
  • Chinese invention patent application CN201110095457.1 discloses an apparatus consisting of a sheath tube and an ablation catheter inserted into the sheath tube, wherein a series of small holes are formed in the distal end of the sheath tube, and the electrode segment of the last segment of the ablation catheter is extended during operation. The small hole of the sheath enters the renal artery for ablation.
  • International application WO2010129661 discloses a saline perfusion radiofrequency ablation catheter with a multi-segment ablation electrode.
  • International application WO2008061152 proposes a device for forming a discontinuous ablation scar along the circumference to avoid stenosis of the blood vessel.
  • International application WO2007121309 proposes a method of simultaneously removing sympathetic nerves in two renal arteries by placing a therapeutic instrument in each of the two renal arteries and forming an ablation circuit between the electrodes respectively fixed on the two instruments and discharging And realized.
  • International application WO2010078175 discloses an apparatus and method for entering the renal artery sympathetic nerve and thermally inducing the renal artery sympathetic nerve, the instrument adopting a multi-segment catheter structure, the first soft segment of the distal end is a bendable segment, and the second soft segment is It is equipped with heating parts.
  • the radiofrequency ablation catheter of the application is composed of multiple segments, two adjustable bending angles, and the catheter can be rotated in the longitudinal direction to obtain a plurality of ablation points to avoid narrowing of the blood vessels.
  • the structure of the catheter 12 is as shown in Fig.
  • the catheter that is simple, fast, and safe to operate and that is suitable for intravascular radiofrequency ablation of the renal artery.
  • the invention provides a catheter for sympathetic radiofrequency ablation through the renal artery adapted to different renal artery inner diameters, simple operation, safety and reliability.
  • the catheter includes: a control handle, a body section, a bendable section, and an electrode, wherein the pull wire extends through the interior of the catheter and is controlled by a control handle.
  • the catheter further comprises a straight section, the electrode is fixed to the end straight section; the pull wire is fixed at one end to the distal end of the end straight section, and the pull wire is arranged along the axis of the duct, the pull line is at the end straight section And on the different sides of the bendable section.
  • the bendable section can be bent in the range of 0-90 degrees. Since the pull wire extends on different sides in the end straight section and the bendable section, the axis of the end straight section to which the electrode is fixed is offset from the axis of the duct when the bendable section is not bent, thereby forming the duct as a whole "S" Bending.
  • the deviation distance of the distal straight segment is set to match the diameter of the renal artery to achieve electrode attachment to the distal segment.
  • the body section of the catheter of the present invention is made of a hard plastic or braided thermoplastic elastomer material having a tube outer diameter of from 1.5 mm to 2.8 mm and a wall thickness of from 0.1 to 1.0 m. By selecting the material, the proper outer diameter and wall thickness provide the catheter with the proper support and flexibility to allow the catheter to smoothly pass through the vessel and avoid damage to the vessel, while allowing the catheter to have a sufficiently large lumen.
  • a guide wire is also disposed inside the catheter for guiding the catheter into the blood vessel.
  • the bendable section of the present invention is made of a thermoplastic elastomer material that is softer than the material of the body section.
  • the outer diameter of the bendable section is the same as or slightly smaller than the diameter of the body section.
  • the effective length of the bendable section is preferably the same as the diameter of the renal artery when the curvature is 90 degrees. In this way, the axis of the end portion to which the electrode is fixed is offset from the axis of the catheter when the bendable portion is not bent, and the diameter of the renal artery is the same, thereby satisfying the requirement of electrode adherence tightness.
  • the average diameter of the male renal artery is 0.60 ⁇ 0.24cm on the left side and 0.67 ⁇ 0.26cm on the right side.
  • the female is: 0.42 ⁇ 0.24cm on the left side and 0.46 ⁇ 0.22cm on the right side. Therefore, the suitable length of the bendable section of the present invention is 3-20 mm.
  • the bendable section and the main section can be fixed together by means of heat splicing, glue bonding or the like.
  • the total length of the electrode-attached end segment of the present invention is 3-10 mm, including the length of the ablation electrode secured to its distal end.
  • the length of the ablation electrode is preferably l-4mm, suitable electrode
  • the diameter is from 1.5mm to 3mm.
  • the last straight section can also be fixed with two electrodes as needed, and the distance between the two electrodes is preferably from 1 to 5 mm.
  • the straight section can be made of the same material as the bendable section.
  • the two sections can have different hardnesses. It is also possible to use raw materials of different hardness to obtain end straight segments and bendable segments having different hardnesses by segmental extrusion. It is also possible to fix two different pipes through a joint of heat splicing, glue bonding or the like to form a bendable section and a straight section.
  • the pull wire is fixed at one end to the distal end of the end straight section, and along the axis of the catheter, the pull wire extends on different sides in the end straight section and the bendable section, respectively.
  • Extending the pull wire on different sides in the bendable section and the end straight section can be accomplished by utilizing a multi-lumen catheter or shrapnel.
  • a multi-lumen catheter along the axis of the catheter, the pull wire is located in the lumen of the different side in the end straight section and the bendable section, and a perforation is provided between the lumens to facilitate the extension of the cable from the bendable section to the end Straight paragraph.
  • the shrapnel is positioned along the axis of the conduit, and the pull wire extends from the bendable section into the final straight section through the perforations provided in the shrapnel.
  • the pull wires are on different sides in the bendable and straight sections.
  • the pull wire is fixed on the control handle at the other end, and is pushed forward by the push button on the control handle to stretch the pull wire, and then the bendable portion is subjected to an eccentric compressive force to generate a bend to realize bending of the bendable portion. Since the pulling wire extends on the other side in the straight straight section, the force has a transmission loss when the pulling wire extends from the bendable section through the perforation into the final straight section, and the lateral force of the straight straight section is small, so the straight straight section can be Keep the axial parallel and straight.
  • the bending of the bendable section changes the distance of the end of the fixed electrode from the axis of the catheter when the bendable section is not bent, so that the whole conduit forms an "S"-shaped bend, thereby satisfying the difference in the electrodes.
  • the bendable section does not bend more than 90 degrees to avoid excessive bending.
  • a chute can be provided on the control handle to control the pull wire by the length of the chute to limit the bending of the curved section. It is also possible to control the cable with a knob or to set up a mechanical mechanism that controls the stroke of the cable. The manner in which the control handle controls the pull wire is well known in the art and is not part of the present invention.
  • the radiofrequency ablation catheter of the present invention is delivered into the renal artery through the guiding tube, and the flexibility of the radiofrequency ablation catheter itself conforms to the curved shape of the guiding tube.
  • the guide tube position is fixed and then the bendable section is controlled by the control handle of the radiofrequency ablation catheter. Under the guidance of X-ray, the bendability of the bendable section is made appropriate, so that the electrode on the end straight section is placed against the blood vessel wall of the renal artery, and then the discharge ablation operation can be started.
  • the catheter of the present invention provides the distal end portion of the catheter into a bendable section and a straight section, and by extending the cord on different sides within the two sections, an "S" bend of the distal end of the catheter can be achieved.
  • the catheter adapts to the attachment of the renal artery of different diameters by controlling the degree of bending of the bendable section.
  • the end straight portion to which the electrode is fixed may be parallel to the axial direction of the catheter main body portion, thereby facilitating the electrode to be completely attached to the wall.
  • the catheter of the present invention has a simple structure, is convenient to operate, is convenient for industrial manufacture, and is advantageous for further increasing functions such as saline perfusion.
  • Figure 1 is a schematic illustration of the overall structure of a prior art "S" curved renal artery radiofrequency ablation catheter.
  • FIG. 2 is a schematic view showing the overall structure of a renal artery radiofrequency ablation catheter according to the present invention.
  • 3A-B are schematic views of the "S"-shaped bending of the catheter according to the present invention, wherein Fig. 3A is a state in which the bendable section is not bent, and Fig. 3B is a state in which the bendable section is bent.
  • Fig. 4 is a schematic view showing several deviation distances of the end straight portion to which the electrode is fixed.
  • Figure 5A is a schematic illustration of a deviation distance suitable for a small diameter renal artery.
  • Fig. 5B is a schematic view of the deviation distance suitable for a large diameter renal artery.
  • Figure 6 is a schematic diagram of electrode position adjustment on the final straight section by rotating the control handle, where the solid line shows the current position of the electrode and the dashed line shows the adjusted electrode position. List of reference signs
  • FIG. 2 is a schematic view showing the overall structure of a catheter suitable for radiofrequency catheter ablation of the renal artery of the present invention.
  • the control handle 5 and its push button and chute arrangement, as well as the sheath 6 and sheath base 7 arrangements, are well known in the art and will not be described in detail herein.
  • the pull wire 10 extends in the bendable section 2 and the end straight section 3 on different sides offset from the axis of the conduit, respectively.
  • the pull wire 10 also extends through the catheter body section 1 and is secured to the control handle 5.
  • By pushing the push button on the control handle forward and applying a force F to the pull wire 10 the bending of the bendable section 2 can be achieved, thereby changing the end of the straight section 3 to which the electrode 4 is fixed, when the bendable section 2 is not bent.
  • the distance of the axis can meet the requirements of electrode attachment of renal artery in different diameters.
  • Figure 3A-B is a schematic view of the structure of the catheter "S"-shaped bending, wherein the bendable section 2 bends After the curve, the end straight section 3 can be parallel to the axis of the catheter when the bendable section 2 is not bent.
  • the pull wire is fixed to the distal end of the end straight section 3, such as the electrode 4.
  • the bendable section 2 and the end straight section 3 to which the electrode 4 is fixed may adopt an integrated double-tube tube pull-line isolation manner, wherein the pull-wire line extends in different lumens in the end straight section and the bendable section respectively, and the pull-wire passes through the setting tube
  • the perforations 12 between the cavities extend from the bendable section 2 into the end straight section 3.
  • the bendable section 2 and the end straight section 3 can also be in the form of the wire isolation of the stainless steel elastic piece 11, wherein the elastic piece 1 1 is positioned along the axis of the catheter, and the pull wire 10 extends from the bendable section 2 into the final through the through hole 12 provided on the elastic piece 11.
  • Fig. 4 is a schematic view showing the different distances of the catheter axis when the bendable section 2 is bent to different degrees, and the end straight section 3 to which the electrode 4 is fixed is offset from the bendable section 2 when it is not bent.
  • the deviation distance Ho is 0; the greater the degree of bending, the farther the deviation distance is, for example, when the degree of bending is as shown by the dotted line in Fig. 4, the deviation distance is 6111111, and when When the bendable section 2 is bent 90 degrees, it is farthest from the axis of the catheter.
  • the furthest distance is related to the length of the bendable section 2.
  • the farthest deviation distance 11 2 is 9 mm.
  • the length of the limit stroke chute on the control handle 5 is set to 15 mm to limit the bend of the bendable section to no more than 90 degrees to avoid excessive bending. 5A and FIG.
  • FIG. 5B are schematic diagrams showing that the electrode fixed to the distal segment can be adhered in the renal artery of different diameters after the bendable segment 2 is bent to different angles, wherein the bending degree shown in FIG. 5A is small and deviated.
  • the distance is 3 mm to accommodate the small diameter renal artery, while the curvature shown in Figure 5B is greater and the offset distance is 5 mm to accommodate the large diameter renal artery.
  • Fig. 6 is a schematic view showing the operation of changing the position of the straight end of the catheter.
  • the renal artery radiofrequency ablation catheter provided by the invention can be adapted to different renal artery diameters, and the distal segment of the fixed electrode is rotated around the catheter body segment under the support of the guiding tube, so the operation is more stable and the blood vessel can be avoided. damage.
  • the present invention is not limited to the specific contents described in the above specific embodiments.
  • the radiofrequency ablation catheter provided by the invention can be applied not only to renal artery ablation for treating hypertension, but also to other intravascular radiofrequency ablation procedures.

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Abstract

一种适合于肾动脉等血管内射频消融的导管，从近端到远端，所述导管包括：控制手柄（5）、主体段（1）、可弯段（2）和电极（4），其中拉线（10）延伸穿过导管内部并由控制手柄（5）控制。所述导管还包括末直段（3），电极（4）固定于末直段（3）；拉线在一端固定于末直段（3）的远端，且拉线（10）被布置成，沿所述导管的轴线，拉线（10）在末直段（3）和可弯段（2）中在不同侧延伸。所述导管能够适应不同的肾动脉内径，加强电极的贴壁效果，采用所述导管对肾动脉进行交感神经射频消融操作简单、安全可靠。

Description

肾动脉射频消融导管 技术领域
本发明总的涉及医疗导管， 更具体涉及一种操作简单、 快速和安 全的适合于肾动脉等血管内消融的导管。 背景技术
高血压具有发病例高、 知晓率低、 危害大的特点。 《中国高血压 防治指南》 （2009年基层版）指出中国每年新增高血压患者 1000万人， 2006年人数已达 2亿， 其中顽固性高血压患者占 20%。 顽固性高血压又称难治性高血压， 是指在采用生活方式改良和 3 种或 3 种以上的降压药物 （包括一种利尿剂） 治疗后仍不能有效控制 的高血压。 实验数据已证明高血压与患者的肾交感神经兴奋性偏高有 关。 阻断肾交感神经不但能够使血压下降， 并且还能够对交感神经过 度激活造成的慢性器官特异性疾病产生影响。 阻断肾交感神经还能改 善左心室肥厚和胰岛素抵抗。 最新的动物及临床随访 2年的实验数据表明采用经皮导管的肾交 感神经射频消融手术可以显著且持久地降低顽固性高血压。 该手术利 用射频能量对肾动脉部位的交感神经进行阻抗式加热， 可减弱肾动脉 部位的交感神经的活性甚至使之丧失传导功能。 这一方法不仅可以有 效治疗顽固性高血压， 而且具有微创、 并发症少等优点。 这种方法被 视为突破性进展， 为治疗顽固性高血压开辟了新的路径。 但是， 目前 尚缺乏专业的手术器械， 特别是专用的射频消融导管来实施这一技术。 用于肾动脉交感神经的射频加热式器械在相关文献中或专利中已 有报道。 中国实用新型专利 CN201469401U提出了一种螺旋型环肾动 脉交感神经射频消融电极导管， 其可沿肾动脉形成非环状封闭的连续 接触消融。 中国发明专利申请 CN201110095457.1公开了由鞘管和装入 鞘管内的消融导管构成的器械， 其中在鞘管的末段开有一系列小孔， 手术时使消融导管的末段的电极段伸出鞘管的小孔进入肾动脉， 以进 行消融。 国际申请 WO2010129661 公开了具有多段消融电极的盐水灌 注射频消融导管。 国际申请 WO2008061152提出一种沿圆周形成不连 续消融疤痕的器械， 以避免血管狭窄。 国际申请 WO2007121309提出 一种在两个肾动脉中同时去交感神经的方法， 这通过在两个肾动脉内 分别放入治疗器械并在分别固定在两个器械上的电极之间构成消融回 路并放电而实现。 但是， 上述现有器械与最终的使用要求还有明显的 距离。 国际申请 WO2010078175公开了进入肾动脉交感神经并对肾动脉 交感神经进行热诱导处理的器械和方法， 该器械采用多段式导管结构， 远端的第一软段为可弯段， 第二软段则装有加热部件。 该申请的射频 消融导管分多段构成， 两处可调弯曲角度， 并且导管可沿纵向进行旋 转以获得多个消融点， 避免血管狭窄。 该导管 12的结构如图 1所示， 其中 16为导管轴， 18为导管的近端部， 20为导管的远端部， 24为加 热元件 （电极） ， 200为手柄组件， 230为旋转器， 260为致动器， 30 为力传动段， 长度为 L1 , 32、 34和 44分别为第一、 第二和第三弯曲 区， 长度分别为 L2、 L3和 L4。 在该申请中， 通过回拉各控制线， 向 各弯曲区施加压缩和弯曲力， 从而使可弯软段弯曲， 由此使加热元件 24朝向肾动脉的内壁移动。 但是， 该申请的导管的操作和结构都比较 复杂。 而且， 该申请的导管不能很好地适应不同直径的肾动脉内壁， 从而使电极无法在不同直径的肾动脉中实现贴壁。 发明内容
有鉴于此， 本发明的目的在于提供一种操作和结构简单、 快速和 安全的适合于肾动脉等血管内射频消融的导管。 本发明提供了一种适应不同肾动脉内径、 操作简单、 安全可靠的 经肾动脉进行交感神经射频消融的导管。 从近端到远端， 所述导管包 括： 控制手柄、 主体段、 可弯段和电极， 其中拉线延伸穿过导管内部 并由控制手柄控制。 其特征在于， 所述导管还包括末直段， 电极固定 于末直段； 拉线在一端固定于末直段的远端， 且拉线被布置成， 沿所 述导管的轴线， 拉线在末直段和可弯段中在不同侧延伸。 通过操作控 制手柄控制拉线， 可使可弯段在 0-90度范围内弯曲。 由于拉线在末直 段和可弯段中在不同侧延伸， 因而使固定有电极的末直段的轴线偏离 导管在可弯段未弯曲时的轴线一定距离， 由此使导管整体形成 " S "形 弯曲。 末直段的偏离距离设置成与肾动脉的直径相匹配， 以实现固定 于末直段的电极贴壁。 本发明的导管的主体段由硬塑料或编织丝加强的热塑性弹性体材 料制成， 导管外径为 1.5mm-2.8mm， 壁厚为 0.1-1.0m。 通过选择材料， 适宜的外径和壁厚可以为导管提供合适的支撑力、 柔顺性， 能够使导 管顺利穿过血管并避免对血管损伤， 同时可以使导管具有足够大的内 腔。 导管内部还布置有导丝， 用于引导导管进入血管内。 本发明的可弯段由比主体段材质软的热塑性弹性体材料制成。 可 弯段的外径尺寸与主体段的管径相同或略小。 可弯段的有效长度以弯 曲 90度时的曲率半径与肾动脉的直径相同为宜。 以此方式， 使固定有 电极的末直段的轴线偏离导管在可弯段未弯曲时的轴线的距离与肾动 脉的直径相同， 从而满足电极贴壁紧密性的要求。 据统计男性肾动脉 的平均管径为： 左侧 0.60±0.24cm， 右侧 0.67±0.26cm; 女性的为： 左 侧 0.42±0.24cm， 右侧 0.46±0.22cm。 因此， 本发明的可弯段的适宜长 度为 3-20mm。 可弯段和主体段之间可以采用热悍接、 胶水粘结等连接 方式固定在一起。 本发明的固定有电极的末直段的总长度为 3-10mm，包括固定于其 远端的消融电极的长度。 消融电极的长度以 l-4mm为宜， 适当的电极 直径尺寸为 1.5mm-3mm。 末直段根据需要也可以固定有 2个电极， 两 个电极之间的距离以 l-5mm为宜。 末直段可以由与可弯段相同的材料 制成。 通过对末直段和可弯段采用不同温度的热处理， 可以使两段具 有不同的硬度。 也可以采用不同硬度的原材料， 通过分段挤出得到具 有不同硬度的末直段和可弯段。 还可以将两段不同的管材通过热悍接、 胶水粘结等连接方式固定在一起来形成可弯段和末直段。 根据本发明， 拉线在一端固定于末直段的远端， 并且沿导管的轴 线， 拉线在末直段和可弯段中分别在不同侧延伸。 使拉线在可弯段和 末直段中在不同侧延伸可以通过利用多腔导管或弹片的隔离方式。 在 采用多腔导管的情情形中， 沿导管的轴线， 拉线在末直段和可弯段中 位于不同侧的管腔内， 管腔之间设有穿孔， 便于拉线从可弯段延伸进 入末直段。 在采用弹片的情形中， 弹片沿导管的轴线定位， 拉线通过 设置于弹片上的穿孔从可弯段延伸进入末直段。 也可以采用其它不同 的隔离方式使拉线在可弯段和末直段中位于不同侧。 在本发明中， 拉线在另一端固定在控制手柄上， 通过控制手柄上 的推钮向前推， 拉伸拉线， 继而使可弯段受到偏心的压缩力， 产生弯 曲， 实现可弯段弯曲。 而由于拉线在末直段中在另一侧延伸， 使力在 拉线从可弯曲段经穿孔延伸进入末直段时有传递损失， 末直段的侧向 受力较小， 所以末直段可以保持轴向平行伸直状态。 按照上述方案， 可弯段的弯曲改变了固定有电极的末直段偏离导管在可弯段未弯曲时 的轴线的距离， 从而使导管整体形成 " S "形弯曲， 由此可满足电极在 不同直径的肾动脉血管内贴壁的要求。可弯段的弯曲程度不超过 90度， 以避免弯曲过度。 可以在控制手柄上设置滑槽， 通过滑槽的长度来控 制拉线， 以限制弯曲段的弯曲程度。 也可以采用旋钮方式控制拉线或 可以设置控制拉线行程的机械机构。 控制手柄控制拉线的方式是本领 域公知的， 其不作为本发明的一部分。 手术时， 选择适合于肾动脉的导引管， 并将导引管的远端开口置 于肾动脉开口处。 然后， 将本发明的射频消融导管通过导引管送至肾 动脉内， 射频消融导管自身的柔顺性会使其顺应导引管的弯形。 固定 导引管位置，然后通过射频消融导管的控制手柄控制可弯段弯曲。在 X 光指导下使可弯段的弯曲程度合适， 由此使末直段上的电极贴靠在肾 动脉血管壁上， 然后即可开始放电消融操作。 保持导引管位置固定， 旋转控制手柄， 然后即可使末直段上的电极在血管内围绕导管主体段 转动。 也可以推进导管或将导管往回撤， 以改变消融电极的位置。 导 引管为本领域公知的介入手术器械， 其不作为本发明的一部分。 根据本发明， 还可以在主体段和可弯段之间增加第二可弯段， 该 第二可弯段用以满足以下需要： 在未使用长导引管而是使用短鞘管时， 能使导管从主动脉弓弯曲进入到肾动脉内。 第二可弯段的长度以
20-60mm为宜。 通过独立的拉线来控制第二可弯段的弯曲。 本发明的导管将导管的远端部分成可弯段和末直段， 通过使拉线 在两段内在不同侧延伸， 能够实现导管的远端部的 " S "形弯曲。 以此 方式， 通过控制可弯段的弯曲程度实现了导管适应不同直径的肾动脉 内的贴壁。 而且， 固定有电极的末直段可以和导管主体段的轴线方向 平行， 从而有利于电极完整地贴壁。 本发明导管的结构简单、 操作方便， 便于产业化制造， 并且有利 于进一步增加盐水灌注等功能。 附图说明
图 1具有现有技术的 " S "弯形的肾动脉射频消融导管的整体结构 示意图。
图 2是根据本发明的肾动脉射频消融导管的整体结构示意图。 图 3A-B是根据本发明的导管实现 " S " 形弯曲的示意图， 其中图 3A是可弯段未弯曲时的状态， 图 3B是可弯段弯曲时的状态。
图 4是固定有电极的末直段的几个偏离距离的示意图。 图 5A是偏离距离适合于小直径肾动脉的示意图。
图 5B是偏离距离适合于大直径肾动脉的示意图。
图 6 是通过转动控制手柄实现末直段上的电极位置调整的示意 图， 其中实线显示的是电极目前的位置， 虚线显示的是调整后的电极 位置。 附图标记列表
1 导管主体段； 2 可弯段； 3末直段； 4消融电极； 5 控制手柄； 6 鞘管； 7 鞘管座； 8 肾动脉； 9肾； 10 拉线； 11 弹片； 12 穿孔。 具体实施方式
下面结合附图对本发明的具体实施方式进行详细说明。 为了便于描述， 这里使用了术语 "远端" 和 "近端" ， 离操作端 (即控制手柄 5 ) 近的一端为近端， 远离操作端的一端为远端。 图 2所示为本发明的适合于肾动脉射频消融的导管整体结构示意 图。 1为导管的主体段，其长度 90cm; 2为导管的可弯段，长度为 12mm; 3为固定有电极 4的末直段，总长度为 7mm;末直段固定有一个电极 4; 导管主体段 1 固定在控制手柄 5上， 控制手柄 5上设有推钮和滑槽， 推钮可在滑槽内滑动； 6、 7分别为鞘管和鞘管座， 导管通过鞘管 6引 入肾动脉 8内， 靠近肾 9。 控制手柄 5及其推钮和滑槽布置以及鞘管 6 和鞘管座 7布置都是本领域公知的技术， 在此不再详述。 拉线 10在可 弯段 2和末直段 3中分别在偏离导管的轴线的不同侧上延伸。 拉线 10 还延伸通过导管主体段 1 并固定在控制手柄 5上。 通过将控制手柄上 的推钮向前推， 向拉线 10施加力 F, 即可实现可弯段 2的弯曲， 进而 改变固定有电极 4的末直段 3偏离导管在可弯段 2未弯曲时的轴线的 距离， 即可满足不同直径肾动脉血管内电极贴壁的要求。 图 3A-B为实现导管 " S " 形弯曲的结构示意图， 其中可弯段 2弯 曲后， 末直段 3 能够与导管在可弯段 2未弯曲时的轴线保持平行。 拉 线固定在末直段 3 的远端， 例如电极 4上。 可弯段 2和固定有电极 4 的末直段 3 可采用一体的双腔管的拉线隔离方式， 其中拉线在末直段 和可弯段中分别在不同管腔内延伸， 拉线通过在设置管腔之间的穿孔 12从可弯段 2延伸进入末直段 3。 可弯段 2和末直段 3也可采用不锈 钢弹片 11 的拉线隔离方式， 其中弹片 1 1沿导管的轴线定位， 拉线 10 通过设置于弹片 11上的穿孔 12从可弯段 2延伸进入末直段 3。 图 4所示为可弯段 2弯曲至不同程度时， 固定有电极 4的末直段 3偏离可弯段 2未弯曲时的导管轴线不同距离的示意图。 初始状态时， 即可弯段 2未弯曲时， 偏离距离 Ho为 0; 弯曲程度越大， 偏离距离越 远， 例如弯曲程度为图 4中虚线所示程度时， 偏离距离 为 6111111， 而 当使可弯段 2弯曲 90度时， 偏离导管的轴线最远。 最远距离与可弯段 2的长度有关。 在本例中， 最远偏离距离 112为 9mm。 在本例中， 控制 手柄 5上的限行程滑槽的长度被设置为 15mm，以限制可弯段的弯曲程 度不超过 90度， 以避免弯曲过度。 图 5A和图 5B 分别为可弯段 2弯曲至不同角度后使固定于末直段 的电极能在不同直径的肾动脉内实现贴壁的示意图，其中图 5A所示的 弯曲程度较小， 偏离距离为 3mm， 以适应小直径的肾动脉， 而图 5B 所示的弯曲程度较大， 偏离距离为 5mm， 以适应大直径的肾动脉。 图 6为改变导管末直段位置的操作示意图。 固定导引管 （鞘管） 位置， 沿方向 A旋转控制手柄， 使导管整体沿方向 B转动， 实现末直 段 3上的电极 4在肾动脉内沿方向 C旋转， 从而实现电极位置的调整。 本发明提供的肾动脉射频消融导管可以适合于不同的肾动脉直 径， 并且固定有电极的末直段在导引管的支撑下围绕导管主体段进行 旋转， 因此操作更稳定， 可以避免对血管的损伤。 本发明不局限于上述具体实施方式中所描述的具体内容。 本发明 所提供的射频消融导管不仅可应用于肾动脉消融治疗高血压， 也适合 于其他血管内的射频消融手术。

Claims

权 利 要 求 书
1. 一种适合于在包括肾动脉的血管内射频消融的导管， 从近端到 远端， 所述导管包括： 控制手柄 （5) 、 主体段 （1) 、 可弯段 （2) 和 电极 （4) ， 其中拉线 （10) 延伸穿过导管内部并由控制手柄 （5) 控 制， 其特征在于， 所述导管还包括末直段 （3) ， 电极 （4) 固定于末 直段 （3) ； 拉线在一端固定于末直段 （3) 的远端， 且拉线 （10) 被 布置成， 沿所述导管的轴线， 拉线 （10) 在末直段 （3) 和可弯段 （2) 中在不同侧延伸。
2. 如权利要求 1所述的导管，其特征在于，所述导管为多腔导管， 沿导管的轴线， 拉线 （10) 在末直段 （3) 和可弯段 （2) 中位于不同 侧的管腔内， 管腔之间设有穿孔 （12) ， 以便于拉线 （10) 从可弯段
(2) 延伸进入末直段 （3) 。
3. 如权利要求 1所述的导管， 其特征在于， 所述导管还包括沿导 管的轴线定位的弹片 （11) ， 拉线 （10) 通过设置于弹片 （11) 上的 穿孔 （12) 从可弯段 （2) 延伸进入末直段 （3) 。
4. 如权利要求 1-3中任一项所述的导管，其特征在于，可弯段（2) 的长度为 3-20mm; 末直段 （3) 的长度为 3-10mm， 包括固定于其远端 的电极 （4) 的长度， 电极 （4) 的长度为 l-4mm， 电极直径尺寸为 1.
5 mm- 3 mm 5. 如权利要求 1-3中任一项所述的导管，其特征在于，可弯段（2) 由比主体段材质软的热塑性弹性体材料制成； 末直段 （3) 由与可弯段 (2) 相同或不同的热塑性弹性体材料制成， 或末直段 （3) 的硬度与 可弯段 （2) 相同或不同。
6. 如权利要求 1-3中任一项所述的导管，其特征在于，可弯段（2) 的弯曲程度被控制在 0-90度。
7. 如权利要求 1-3中任一项所述的导管， 其特征在于， 所述导管 在主体段 （1 ) 和可弯段 （2 ) 之间还包括另外的可弯段， 其长度为 20-60mm, 通过另外的拉线控制其弯曲程度。
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