一种肾动脉射频消融电极导管Renal artery radiofrequency ablation electrode catheter技术领域Technical field本发明涉及一种医用电极导管,尤其涉及一种肾动脉射频消融电极导管。The invention relates to a medical electrode catheter, in particular to a renal artery radiofrequency ablation electrode catheter.
背景技术Background technique顽固性高血压在临床上常见,致病因素较多,发病机制不明确,药物治疗的效果差,诊断和治疗手段不够成熟,成为高血压治疗的主要难题之一,且此病的患者常伴有其他心血管疾病的危险因素,如冠心病、糖尿病、心率衰竭、肾病、周围动脉疾病、中风、左心室肥厚等。在高血压的各类并发症中,以心、脑、肾的损害最为显著,例如世界卫生组织统计,50%的心血管疾病是由高血压引起的。目前因血压值升高,发生心脑血管事件导致死亡的人数每年全球约有710万,而我国40岁以上人群的死亡因素中,心脏病和脑血管病分别列为第一位和第三位,总死亡的第一危险因素是高血压。Refractory hypertension is common in clinical practice, with many pathogenic factors, unclear pathogenesis, poor drug treatment, and insufficient diagnosis and treatment. It has become one of the major problems in the treatment of hypertension, and patients with this disease often There are other risk factors for cardiovascular disease, such as coronary heart disease, diabetes, heart failure, kidney disease, peripheral arterial disease, stroke, left ventricular hypertrophy and so on. Among the various complications of hypertension, the damage of heart, brain and kidney is the most significant. For example, according to the World Health Organization, 50% of cardiovascular diseases are caused by high blood pressure. At present, due to the increase in blood pressure, the number of deaths from cardiovascular and cerebrovascular events is about 7.1 million worldwide. Among the death factors among people over 40 years old, heart disease and cerebrovascular disease are ranked first and third respectively. The first risk factor for total death is high blood pressure.
医学界一直认为,肾脏的交感神经兴奋和血压升高有密切关系。肾脏的交感神经过度兴奋时,肾脏血管收缩,减少肾脏的排泌,使水分和盐潴留在体内,同时促进肾脏分泌肾素,导致了血管中血压紧张素Ⅱ和醛固酮的增加,而后两种物质,正是血压升高的因素。The medical community has always believed that sympathetic excitation and elevated blood pressure in the kidney are closely related. When the sympathetic nerve of the kidney is over-excited, the renal vasoconstriction reduces the excretion of the kidney, leaving the water and salt in the body, and promotes the secretion of renin from the kidney, which leads to an increase in blood pressure in the blood pressure angiotensin II and aldosterone, and the latter two substances. It is the factor that raises blood pressure.
这种降压治疗新方法的理论基础是:肾脏的交感神经传入和传出纤维分布在肾动脉壁下方的浅表面部位,其活性与高血压的发生和维持密切相关,在肾动脉局部进行射频消融能损毁肾脏交感神经而不累及其他腹部、盆部或下肢的神经组织。因而这种去神经治疗高血压的方法安全性良好。并且在疗效方面,研究经过12个月的观察可知,治疗后1个月时,病人的血压明显降低,3个月时其血压进一步降低、1年时血压降低效果依然非常明显,同时亦未发现明显的神经再生。The theoretical basis of this new method of antihypertensive therapy is that the sympathetic afferent and efferent fibers of the kidney are distributed on the shallow surface of the renal artery wall, and its activity is closely related to the occurrence and maintenance of hypertension, and is performed locally in the renal artery. Radiofrequency ablation can damage the kidney sympathetic nerves without involving other abdomen, pelvic or lower limb nerve tissue. Therefore, this method of denervation for treating hypertension is safe. In terms of curative effect, after 12 months of observation, the blood pressure of the patient was significantly reduced at 1 month after treatment, and the blood pressure was further lowered at 3 months, and the blood pressure reduction effect was still very high at 1 year.Obviously, no significant nerve regeneration was found.
目前,该技术领域已有如下相关设备:如专利号为200920172984.6的中国专利,公开了一种螺旋状环肾动脉交感神经射频消融电极导管,其基本原理是,在导管端部固接一特定形状的消融电极,此类设备虽然可以对肾动脉进行消融,但存在消融电极的直径等尺寸固定,不能进行调节,无法保证消融电极跟肾动脉血管内壁紧密贴靠,而且不能进行实时的温度监控,无法精确控制消融温度,极容易使得消融程度不够或者消融过度,进而造成肾动脉血管穿孔等事故的问题。At present, the related art has the following related equipment: such as the Chinese patent No. 200920172984.6, discloses a spiral ring renal artery sympathetic radiofrequency ablation electrode catheter, the basic principle is that a specific shape is fixed at the end of the catheter. The ablation electrode, although the device can ablate the renal artery, but the diameter of the ablation electrode is fixed and cannot be adjusted, and the ablation electrode cannot be closely adhered to the inner wall of the renal artery, and real-time temperature monitoring cannot be performed. It is impossible to precisely control the ablation temperature, and it is very easy to make the degree of ablation insufficient or excessive ablation, which may cause an accident such as perforation of the renal artery.
美国专利US20130006238A1(Catheter with variable arcuate distal section)公开了一种远端螺旋或月牙形导管,其远端可控弯,同时圈径可调,主要通过内部定型丝将远端定型为螺旋或月牙形,通过手柄控制远端控弯以及调节圈径。其缺点在于远端多腔管内部需要添加很多组件,造成整个多腔的直径比较大,在进行肾动脉消融时可能会有由外径较大造成的术士繁琐等情况。US Patent No. US20030006238A1 (Catheter with variable arcuate distal section) discloses a distal spiral or crescent shaped catheter with a distally controllable bend and an adjustable diameter, which is shaped primarily as a spiral or crescent by internal shaping wires. Control the remote control bend and adjust the ring diameter through the handle. The disadvantage is that a lot of components need to be added inside the distal multi-lumen tube, resulting in a relatively large diameter of the entire multi-cavity, and there may be a cumbersome warlock caused by a large outer diameter when the renal artery is ablated.
公开号为CN 203029378 U,专利名称为《球囊电极肾动脉射频消融导管》的中国专利公开了一种球囊导管,将球囊与导管连接,利用球囊的扩张使得球囊上的电极与肾动脉壁贴靠,从而进行射频消融。其优点在于,该导管能够根据肾动脉血管尺寸不一致进行紧密贴靠;缺点在于在球囊扩张后,整个肾动脉血管被球囊封堵,血流受阻,存在一定的风险。Chinese Patent Publication No. CN 203029378 U, entitled "Carotid Electrode Radiofrequency Ablation Catheter for Balloon Electrodes" discloses a balloon catheter that connects the balloon to the catheter and utilizes the expansion of the balloon to cause the electrode on the balloon to The renal artery wall is placed against it for radiofrequency ablation. The advantage is that the catheter can be closely adhered according to the inconsistency of the renal artery blood vessel size; the disadvantage is that after the balloon is expanded, the entire renal artery blood vessel is blocked by the balloon, and the blood flow is blocked, which has certain risks.
公开号为CN 203059897 U,专利名称为《球囊轨道射频消融导管》的中国专利公开了一种轨道射频消融导管,将导管的螺旋段连接一个支撑杆,通过支撑杆的推缩来控制螺旋大小使得螺旋段上的电极与血管内壁进行贴靠,从而进行射频消融。其优点在于,该导管能够根据肾动脉血管尺寸不一致进行紧密贴靠;缺点在于支撑杆需具备一定的硬度,导管通过股动脉穿刺进入到肾动脉不顺畅,且支撑杆与螺旋近端连接处密封性不好,血液容易在此处形成血栓,存在一定的风险。Chinese Patent No. CN 203059897 U, entitled "Cellular Orbital Radio Frequency Ablation Catheter" discloses an orbital radio frequency ablation catheter that connects the helical section of the catheter to a support rod and controls the size of the helix by pushing and contracting the support rod. The electrode on the spiral segment is placed against the inner wall of the blood vessel for radio frequency ablation. The advantage is that the catheter can be closely abutted according to the inconsistent size of the renal artery; the disadvantage is that the support rod needs to have a certain hardness, the catheter is penetrated through the femoral artery into the renal artery, and the support rod and the proximal end of the spiral are sealed. Bad sex, bloodIt is easy to form a thrombus here, and there is a certain risk.
发明内容Summary of the invention
本发明所要解决的技术问题是提供一种肾动脉射频消融电极导管,可以对消融电极的角度和消融部位进行灵活调整,且结构简单,使用安全方便。The technical problem to be solved by the present invention is to provide a renal artery radiofrequency ablation electrode catheter, which can flexibly adjust the angle and ablation site of the ablation electrode, and has a simple structure and is safe and convenient to use.
本发明为解决上述技术问题而采用的技术方案是提供一种肾动脉射频消融电极导管,包括导管主体段、导管螺旋段和手把,所述导管主体段的一端与所述导管螺旋段相连,所述导管主体段的另一端与所述手把相连,所述手把上设置有调圈结构,所述调圈结构用于控制所述导管螺旋段在螺旋状和直行状之间切换,所述导管螺旋段上设置有电极。The technical solution adopted by the present invention to solve the above technical problem is to provide a renal artery radiofrequency ablation electrode catheter, comprising a catheter body segment, a catheter spiral segment and a handle, and one end of the catheter body segment is connected to the catheter spiral segment. The other end of the catheter body segment is connected to the handlebar, and the handlebar is provided with a ring-regulating structure for controlling the spiral section of the catheter to be switched between a spiral shape and a straight line shape. An electrode is disposed on the helical section of the catheter.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段内具有第一腔,所述第一腔内设置有支撑杆,所述支撑杆与所述调圈结构相连接,所述第一腔内侧或支撑杆上覆盖有一层爽滑涂层。The renal artery radiofrequency ablation electrode catheter, wherein the catheter has a first cavity in the spiral segment, a support rod is disposed in the first cavity, and the support rod is connected to the adjustment ring structure, the first The inner side of the cavity or the support rod is covered with a smooth coating.
上述的肾动脉射频消融电极导管,其中,所述调圈结构包括调圈推钮;所述支撑杆的近端与所述调圈推扭固定连接;所述调圈结构还包括与所述调圈推扭连接的第一滑块,所述第一滑块设置在所述手把上的凹槽内且可沿着所述手把的轴向在所述凹槽内移动。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the ring-regulating structure comprises a ring-adjusting button; the proximal end of the supporting rod is fixedly connected with the adjusting ring; the adjusting ring structure further includes The first slider is coupled to the first slider, and the first slider is disposed in a recess in the handle and movable in the recess along an axial direction of the handle.
上述的肾动脉射频消融电极导管,其中,所述爽滑涂层采用具有爽滑且硬度较低的高分子材料制成。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the smooth coating is made of a polymer material having a smooth and low hardness.
上述的肾动脉射频消融电极导管,其中,所述爽滑涂层的材料为PTFE或PFA。The renal artery radiofrequency ablation electrode catheter described above, wherein the material of the smooth coating is PTFE or PFA.
上述的肾动脉射频消融电极导管,其中,所述支撑杆为具备一定硬度和形状记忆功能的金属棒。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the support rod is a metal rod having a certain hardness and shape memory function.
上述的肾动脉射频消融电极导管,其中,所述支撑杆的材质为不锈钢或镍钛合金。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the support rod is made of stainless steel or nickel titanium alloy.
上述的肾动脉射频消融电极导管,其中,所述支撑杆的直径为0.2-0.5mm。The renal artery radiofrequency ablation electrode catheter described above, wherein the support rod has a diameter of 0.2-0.5 mm.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段内具有第一腔,所述第一腔内设置有支撑杆,所述支撑杆与所述调圈结构相连接,所述支撑杆的远端末设置有过渡件,所述过渡件固定在支撑杆的远端末或游离在所述第一腔内。The renal artery radiofrequency ablation electrode catheter, wherein the catheter has a first cavity in the spiral segment, a support rod is disposed in the first cavity, and the support rod is connected to the adjustment ring structure, the support rod The distal end is provided with a transition piece that is fixed at the distal end of the support rod or freed within the first chamber.
上述的肾动脉射频消融电极导管,其中,所述过渡件为弹簧或者亲水爽滑涂层。The renal artery radiofrequency ablation electrode catheter described above, wherein the transition piece is a spring or a hydrophilic smooth coating.
上述的肾动脉射频消融电极导管,其中,所述过渡件为所述弹簧,所述弹簧的末端弹簧帽与所述支撑杆的远端末固定在一起。The renal artery radiofrequency ablation electrode catheter described above, wherein the transition piece is the spring, and an end spring cap of the spring is fixed to a distal end of the support rod.
上述的肾动脉射频消融电极导管,其中,所述弹簧的末端弹簧帽与支撑杆的经过磨细处理的远端末固定在一起。The renal artery radiofrequency ablation electrode catheter described above, wherein the end spring cap of the spring is fixed to the milled distal end of the support rod.
上述的肾动脉射频消融电极导管,其中,所述过渡件为所述亲水爽滑涂层,所述亲水爽滑涂层为具备爽滑性的胶水层。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the transition piece is the hydrophilic smooth coating layer, and the hydrophilic smooth coating layer is a water-repellent layer having a smoothness.
上述的肾动脉射频消融电极导管,其中,所述手把上还设置有控弯旋钮,所述控弯旋钮用于控制所述导管螺旋段的偏转角度。In the above-mentioned renal artery radiofrequency ablation electrode catheter, the handlebar is further provided with a bending knob for controlling the deflection angle of the catheter spiral segment.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段的材质为具有定型能力的高分子材料。The renal artery radiofrequency ablation electrode catheter, wherein the catheter spiral segment is made of a polymer material having a styling ability.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段中还设有镍钛定型丝,用于使得所述导管螺旋段具有螺旋状。The renal artery radiofrequency ablation electrode catheter, wherein the catheter spiral segment is further provided with a nickel-titanium shaped wire for making the catheter spiral segment have a spiral shape.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段还包括:第二腔,其内设置有盐水管;第三腔,其为导线腔,设置有与所述电极相连的导线;以及第四腔,其内设置有与所述控弯旋钮相连的控弯线。The renal artery radiofrequency ablation electrode catheter, wherein the catheter spiral segment further comprises: a second chamber in which a saline tube is disposed; and a third chamber, which is a lead lumen, provided with a wire connected to the electrode; The fourth cavity is provided with a bend line connected to the bend knob.
上述的肾动脉射频消融电极导管,其中,所述控弯线材质为镍钛丝、不锈钢丝或扁平的不锈钢片。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the bend line is made of nickel titanium wire, stainless steel wire or flat stainless steel piece.
上述的肾动脉射频消融电极导管,其中,所述控弯线的一端连接到所述导管主体段与所述导管螺旋段的分界处,另一端连接到控弯旋钮的第二滑块上;所述控弯旋钮与第二滑块之间通过螺纹螺杆结构连接。The renal artery radiofrequency ablation electrode catheter, wherein one end of the bend line is connected to a boundary between the catheter body segment and the catheter spiral segment, and the other end is connected to a second slider of the bend knob; The control bend knob and the second slider are connected by a threaded screw structure.
上述的肾动脉射频消融电极导管,其中,所述手把端部还设置有鲁尔接头,所述鲁尔接头可连接灌注泵将冷盐水送入所述导管从所述盐水孔喷出。The renal artery radiofrequency ablation electrode catheter, wherein the handle end is further provided with a luer connector, and the luer connector can be connected to a perfusion pump to send cold saline into the catheter to be ejected from the saline hole.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段上设置有多个所述电极,每个所述电极上均匀排布多个所述盐水孔。The renal artery radiofrequency ablation electrode catheter, wherein a plurality of the electrodes are disposed on the helical section of the catheter, and a plurality of the saline wells are evenly arranged on each of the electrodes.
上述的肾动脉射频消融电极导管,其中,每个电极上的所述盐水孔的数量为8-16个,所述盐水孔的直径大小为0.08mm-0.16mm。The renal artery radiofrequency ablation electrode catheter described above, wherein the number of the saline wells on each electrode is 8-16, and the diameter of the saline well is 0.08 mm - 0.16 mm.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段的偏转角度为0-90度。The renal artery radiofrequency ablation electrode catheter described above, wherein the catheter spiral segment has a deflection angle of 0-90 degrees.
上述的肾动脉射频消融电极导管,其中,所述导管螺旋段的直径为5mm-10mm。The renal artery radiofrequency ablation electrode catheter described above, wherein the catheter spiral segment has a diameter of 5 mm to 10 mm.
上述的肾动脉射频消融电极导管,其中,所述导管主体段的材质为聚氨酯或Pebax。The above-mentioned renal artery radiofrequency ablation electrode catheter, wherein the catheter body segment is made of polyurethane or Pebax.
本发明对比现有技术有如下的有益效果:本发明提供的肾动脉射频消融电极导管,包括手把、导管主体段和导管螺旋段,所述导管螺旋段上设置有消融电极,手把上设置调圈推扭,所述调圈推扭可以控制导管螺旋段在螺旋状和直行状之间切换,便于导管在肾动脉血管内运动选择合适的消融部位;特别是在手把上控弯旋钮,可以控制导管螺旋段的偏转角度,从而使得调直的导管能够通过肾动脉口进入肾动脉,以及通过调节偏转角度避免进入肾动脉的分支。因此,本发明提供的肾动脉射频消融电极导管结构简单,便于手术过程中导管进入目标血管进行射频消融,通过在肾动脉轴向方向上,对投影径向一圈的肾动脉进行消融,达到整圈隔离神经传导,从而到达治疗顽固性高血压的目的。Compared with the prior art, the present invention has the following beneficial effects: the renal artery radiofrequency ablation electrode catheter provided by the present invention comprises a handle, a catheter main body segment and a catheter spiral segment, wherein the catheter spiral segment is provided with an ablation electrode, and the handle is arranged The twisting and twisting can control the spiral section of the catheter to switch between the spiral shape and the straight line shape, so that the catheter can move in the renal artery to select a suitable ablation site; in particular, the knob is controlled on the handlebar. The angle of deflection of the helical section of the catheter can be controlled such that the straightened catheter can enter the renal artery through the renal artery orifice and avoid branching into the renal artery by adjusting the angle of deflection. Therefore, the renal artery radiofrequency ablation electrode catheter provided by the invention has a simple structure, facilitates radiofrequency ablation of the catheter into the target blood vessel during the operation, and ablate the renal artery that projects a radial circle in the axial direction of the renal artery to achieve the whole Circle isolated nerve conduction,Thereby reaching the goal of treating refractory hypertension.
附图说明DRAWINGS图1(a)为本发明的导管螺旋段的结构示意图;图1(b)为本发明的导管螺旋段在肾动脉血管内释放示意图;1(a) is a schematic structural view of a catheter spiral segment of the present invention; and FIG. 1(b) is a schematic view showing the catheter spiral segment of the present invention in a renal artery intravascular release;
图2(a)为本发明实施例中的肾动脉射频消融电极导管的整体结构示意图;图2(b)为本发明的导管螺旋段的结构示意图;2(a) is a schematic view showing the overall structure of a renal artery radiofrequency ablation electrode catheter according to an embodiment of the present invention; and FIG. 2(b) is a schematic structural view of a catheter spiral segment of the present invention;
图3(a)为本发明实施例中的导管螺旋段处于螺旋状的示意图;图3(b)为本发明的导管螺旋段处于直行状的示意图;3(a) is a schematic view showing the spiral section of the catheter in a spiral shape in the embodiment of the present invention; and FIG. 3(b) is a schematic view showing the spiral section of the catheter in a straight line according to the present invention;
图4(a)为本发明实施例中的导管螺旋段的局部解剖示意图;图4(b)为图4(a)中沿A-A的剖面示意图;图4(c)为图4(a)中沿B-B的剖面示意图;4(a) is a partial anatomical view of a spiral section of a catheter in an embodiment of the present invention; FIG. 4(b) is a cross-sectional view along AA of FIG. 4(a); and FIG. 4(c) is a diagram of FIG. 4(a) A schematic view of the section along BB;
图5(a)为本发明实施例中的支撑杆和弹簧圈式过渡件的结构示意图;图5(b)为本发明的支撑杆和胶水式过渡件的结构示意图。FIG. 5( a ) is a structural schematic view of a support rod and a spring coil transition piece according to an embodiment of the present invention; and FIG. 5( b ) is a structural schematic view of the support rod and the glue type transition piece of the present invention.
图中:In the picture:
11-导管主体段 12-导管螺旋段 13-控弯旋钮11-catheter body section 12-catheter spiral section 13-bend knob
14-调圈推钮 15-手把 16-鲁尔接头14-adjustment push button 15-handle 16-Ruer connector
17-盐水孔 18-电极 21-盐水管17-salt hole 18-electrode 21-salt tube
22-多腔管 23-爽滑涂层 24-支撑杆22-multi-lumen tube 23-slip coating 24-support rod
25-控弯线 26-导线腔 27-过渡件25-controlled bending line 26-wire cavity 27-transition piece
28-导线28-wire
具体实施方式detailed description下面结合附图和实施例对本发明作进一步的描述。The invention will now be further described with reference to the drawings and embodiments.
图1(a)为本发明的导管螺旋段的结构示意图;图1(b)为本发明的导管螺旋段在肾动脉血管内释放示意图。Fig. 1(a) is a schematic view showing the structure of a catheter spiral segment of the present invention; and Fig. 1(b) is a schematic view showing the intravascular catheter release of a catheter spiral segment of the present invention in a renal artery.
请参见图1(a)和图1(b),治疗顽固性高血压优选对肾动脉进行整圈神经消融,传统的环形消融导管进行整圈消融时容易造成肾动脉血管狭窄,而本发明所公开的螺旋状导管,如图1(a)所示,通过在肾动脉轴向方向上,对投影径向一圈的肾动脉进行消融,如图1(b)所示,达到整圈隔离神经传导,从而到达治疗顽固性高血压的目的。Referring to FIG. 1(a) and FIG. 1(b), in the treatment of refractory hypertension, it is preferable to perform a full-circle nerve ablation of the renal artery, and the conventional annular ablation catheter is likely to cause renal artery vascular stenosis when performing a full circle ablation, and the present invention The disclosed helical catheter, as shown in Fig. 1(a), ablate the renal artery that projects a radial circle in the axial direction of the renal artery, as shown in Fig. 1(b), reaching the entire circle of isolated nerve Conduct to reach the goal of treating refractory hypertension.
图2(a)为本发明实施例中的肾动脉射频消融电极导管的整体结构示意图;图2(b)为本发明的导管螺旋段的结构示意图。2(a) is a schematic view showing the overall structure of a renal artery radiofrequency ablation electrode catheter according to an embodiment of the present invention; and FIG. 2(b) is a schematic structural view of a catheter spiral segment of the present invention.
请参见图2(a)和图2(b),本发明提供的肾动脉射频消融电极导管,包括导管主体段11、导管螺旋段12、手把15以及鲁尔接头16,导管主体段11的一端与导管螺旋段12相连,导管主体段11的另一端与手把15相连,手把15上设置有调圈推扭14和控弯旋钮13,调圈推扭14用于控制导管螺旋段12在如图3(a)所示的螺旋状和如图3(b)所示的直行状之间切换,控弯旋钮13用于控制导管螺旋段12的偏转角度θ,导管螺旋段12上设置有电极18。2(a) and 2(b), the present invention provides a renal artery radiofrequency ablation electrode catheter comprising acatheter body segment 11, acatheter spiral segment 12, ahandlebar 15 and aLuer connector 16, thecatheter body segment 11 One end is connected to thecatheter spiral section 12, and the other end of the cathetermain body section 11 is connected to thehandlebar 15. Thehandlebar 15 is provided with a ring-turningtwisting 14 and a bendingknob 13 for controlling thescrew section 12 of the catheter. Switching between the spiral shape as shown in Fig. 3 (a) and the straight line as shown in Fig. 3 (b), thecontrol knob 13 is used to control the deflection angle θ of thecatheter spiral section 12, which is disposed on thecatheter spiral section 12. There areelectrodes 18.
本发明的导管主体段11的材质一般为聚氨酯材料,也可以为尼龙弹性体(Pebax),管径无特殊要求,根据所使用的肾动脉血管一般以不超过8F为宜,导管螺旋段12材质一般为Pebax,也可以为其他适宜的高分子材料,管径以不超过7F为宜,导管螺旋段12在没有外力的作用下呈螺旋状,其每一圈的直径优选在5mm-10mm之间,以适用于不同肾动脉血管直径。The material of thecatheter body segment 11 of the present invention is generally a polyurethane material or a nylon elastomer (Pebax), and the diameter of the catheter is not particularly required, and the diameter of the catheter is preferably not more than 8F depending on the renal artery used. Generally, it is Pebax, and it can also be other suitable polymer materials. The diameter of the pipe is preferably not more than 7F. Thespiral section 12 of the pipe is spiraled without external force, and the diameter of each ring is preferably between 5mm and 10mm. To suit the diameter of different renal arteries.
如图2(b)所示,导管螺旋段12上分布有带盐水孔17的凸台环电极18,当射频提供能量时,凸台环电极18能在肾动脉内壁中产生6-15W的功率,优选的功率为10W,从而使得肾动脉上的传导神经失活,达到治疗顽固性高血压的目的,与此同时,鲁尔接头16连接灌注泵将冷盐水送入导管从电极盐水孔17喷出,达到灌注消融电极的目的,从而更好地消融肾动脉内壁组织,盐水灌注流量一般在10ml/min-20ml/min,优选的为17ml/min。导管螺旋段12上排布多个电极18,一般为4-5个,每个电极18上均匀排布多个盐水孔17,一般为8-16个,盐水孔17直径大小为0.08mm-0.16mm。As shown in Fig. 2(b), aboss ring electrode 18 with asaline hole 17 is distributed on thecatheter spiral section 12. When the radio frequency provides energy, theboss ring electrode 18 can generate 6-15 W of power in the inner wall of the renal artery. The preferred power is 10W, so that the conduction nerve on the renal artery is inactivated for the purpose of treating refractory hypertension. At the same time, theLuer connector 16 is connected with a perfusion pump to send cold saline into the catheter and spray from theelectrode saline hole 17. The purpose of perfusion ablation electrode is achieved to better ablate the inner wall tissue of the renal artery, and the saline perfusion flow rate is generally 10 ml/min to 20 ml/min, preferably 17 ml/min. CatheterA plurality ofelectrodes 18 are arranged on thespiral section 12, generally 4-5, and a plurality ofsalt water holes 17 are uniformly arranged on eachelectrode 18, generally 8-16, and the diameter of thesalt water hole 17 is 0.08 mm-0.16 mm. .
图3(a)为本发明实施例中的导管螺旋段在螺旋状的示意图;图3(b)为本发明的导管螺旋段在直行状的示意图。需要说明的是,所述直行状是相对于螺旋状而言更趋近于直线状,但本发明并不要求所述直行状达到严格的直线状,只要所述直行状的导管螺旋段12能够在肾动脉中通行即可。Fig. 3(a) is a schematic view showing the spiral section of the catheter in a spiral shape in the embodiment of the present invention; and Fig. 3(b) is a schematic view showing the spiral section of the catheter of the present invention in a straight line shape. It should be noted that the straight line shape is closer to a linear shape than the spiral shape, but the present invention does not require the straight line shape to be strictly linear, as long as the straight line-shapedcatheter spiral section 12 can It can be used in the renal artery.
请参见图3(a)和图3(b),本发明的导管螺旋段12可以通过手把15上的调圈推扭14,使得导管螺旋段12在螺旋状和直行状之间切换,可进行伸缩,以便于导管在肾动脉血管内运动选择合适的消融部位;手把15上的控弯旋钮13可以调节导管螺旋段12在一定角度内(角度范围在0°-90°之间)发生偏转,例如图2(b)显示了导管螺旋段12从大致与导管主体段11的延伸方向重合的第一方向L1偏转了角度θ后到达第二方向L1的示意图。通过调圈推扭14和控弯旋钮13的控制,使得调直的导管能够通过肾动脉口进入肾动脉,以及通过调节偏转角度避免进入肾动脉的分支。Referring to FIG. 3(a) and FIG. 3(b), thecatheter spiral segment 12 of the present invention can be twisted and twisted 14 by the adjustment ring on thehandlebar 15, so that thecatheter spiral segment 12 is switched between a spiral shape and a straight line shape. Stretching is performed to facilitate the movement of the catheter within the renal artery to select a suitable ablation site; thebend knob 13 on thehandle 15 can adjust thehelical section 12 of the catheter to occur within a certain angle (ranging from 0° to 90°) The deflection, for example, Fig. 2(b) shows a schematic view of the catheterhelical section 12 reaching the second direction L1 after being deflected by an angle θ from a first direction L1 substantially coincident with the direction of extension of thecatheter body section 11. By adjusting theloop push 14 and controlling thebend knob 13, the straightened catheter can enter the renal artery through the renal artery orifice and avoid branching into the renal artery by adjusting the deflection angle.
图4(a)为本发明实施例中的导管螺旋段的局部解剖示意图;图4(b)为图4(a)中沿A-A的剖面示意图;图4(c)为图4(a)中沿B-B的剖面示意图。下文中所述“远端”或“末”均指远离手把15的一端。4(a) is a partial anatomical view of a spiral section of a catheter in an embodiment of the present invention; FIG. 4(b) is a cross-sectional view along AA of FIG. 4(a); and FIG. 4(c) is a diagram of FIG. 4(a) A schematic view of the section along BB. The term "distal" or "end" as used hereinafter refers to the end that is remote from thehandlebar 15.
请参见图4(a)至图4(c),本发明的导管螺旋段12材质一般为尼龙弹性体(Pebax)或其他高分子,该种材料在热处理之后具有一定的定型能力,故导管螺旋段12定型可依靠NITI定型丝或者该高分子材质本身进行定型,如使用本身材质进行定型,可以简化导管内部结构。本发明中的导管螺旋段12设计成多腔管22,多腔管22一般在4腔及以上,其中第一腔设置有与调圈推扭14相连的支撑杆24,实现导管螺旋段12在螺旋状和直行状之间切换,其中第一腔内侧经过特殊处理,叠加有一层爽滑涂层23,如聚四氟乙烯(PTFE)、全氟烷氧基树脂(PFA)等之类具有爽滑硬度较低的高分子材料,用于减少将导管螺旋段12推直的摩擦阻力以及避免可能造成的破腔等情况发生。Referring to FIG. 4( a ) to FIG. 4( c ), thecatheter spiral segment 12 of the present invention is generally made of a nylon elastomer (Pebax) or other polymer, and the material has a certain shaping ability after heat treatment, so thecatheter spiral Section 12 can be shaped by NITI shaped wire or the polymer material itself. If it is shaped by its own material, it can simplify the internal structure of the pipe. Thecatheter spiral segment 12 of the present invention is designed as amulti-lumen tube 22, and themulti-lumen tube 22 is generally in four chambers or more, wherein the first chamber is provided with asupport rod 24 connected to thecoil pusher 14 to realize thecatheter spiral segment 12 Switching between spiral and straight, wherein the inside of the first cavity is specially treated, superimposed with asmooth coating 23, such as polytetrafluoroethylene (PTFE), perfluoroalkoxy resin (PFA), etc. Low slip hardness polymerThe material is used to reduce the frictional resistance of pushing theconduit section 12 straight and to avoid possible breakage of the cavity.
较佳地,支撑杆24的远端末位置设置有过渡件27,过渡件27固定在支撑杆24的远端末或游离在带爽滑涂层23的第一腔内,支撑杆24的近端与调圈推扭14固定连接;调圈推扭14连接有第一滑块,第一滑块设置在手把15上的凹槽内且可沿着手把15的轴向在所述凹槽内移动,从而实现推动调圈推扭14带动具有过渡件27的支撑杆24在第一腔内沿轴向移动。由于支撑杆24的硬度足够支撑导管螺旋段12,当带有过渡件27的支撑杆24被推送到导管螺旋段12末的位置,整个导管螺旋段12可依从支撑杆24的支撑呈直行状,而当具有过渡件27的支撑杆24整个回撤出螺旋段,由于导管螺旋段12本身的定型能力,其会恢复到原来的螺旋形状。Preferably, the distal end position of thesupport rod 24 is provided with atransition piece 27 which is fixed at the distal end of thesupport rod 24 or free in the first chamber with thesmooth coating 23, the proximal end of thesupport rod 24 and Thering push pin 14 is fixedly connected; thering push pin 14 is connected with a first slider, and the first slider is disposed in the groove on thehandle 15 and can move in the groove along the axial direction of thehandle 15 Therefore, thepush ring 14 is driven to drive thesupport rod 24 having thetransition piece 27 to move axially in the first cavity. Since the stiffness of thesupport rod 24 is sufficient to support thecatheter spiral section 12, when thesupport rod 24 with thetransition piece 27 is pushed to the end of thecatheter spiral section 12, the entirecatheter spiral section 12 can follow the support of thesupport rod 24 in a straight line. When thesupport rod 24 having thetransition piece 27 is entirely withdrawn from the spiral section, it will return to the original spiral shape due to the shaping ability of thecatheter spiral section 12 itself.
第二腔设置了盐水管21,用于灌注盐水;第三腔为导线腔26,设置有用于连接消融电极18所需的导线28,包括RF和TC线,第四腔内设置有与控弯旋钮13相连的控弯线25,控弯旋钮13与控弯线25配合控制导管螺旋段12的偏转角度θ;控弯线25材质可以为Niti丝、不锈钢丝或扁平的不锈钢片,控弯线25的一端连接到导管主体段11与导管螺旋段12分界处,另一端连接到控弯旋钮13的第二滑块(图未示)上;控弯旋钮13与第二滑块之间通过螺纹螺杆结构连接,从而旋转控弯旋钮13使得第二滑块沿手把15的轴向移动,带动控弯线25,实现导管螺旋段12在0°-90°之间控弯偏转。The second chamber is provided with asaline tube 21 for infusing saline; the third chamber is alead chamber 26 provided with awire 28 for connecting theablation electrode 18, including RF and TC lines, and a fourth chamber is provided with a bend Thebending line 25 connected to theknob 13 and the bendingknob 13 and thebending line 25 cooperate to control the deflection angle θ of thescrew section 12 of the catheter; the material of thebending line 25 can be Niti wire, stainless steel wire or flat stainless steel piece, and the bending line is controlled. One end of 25 is connected to the boundary between theconduit body segment 11 and theconduit spiral section 12, and the other end is connected to the second slider (not shown) of thecurved knob 13; the threadedknob 13 and the second slider are threaded. The screw structure is connected, so that therotation knob 13 is rotated to move the second slider along the axial direction of thehandlebar 15, and thebending line 25 is driven to realize the deflection of thecatheter spiral section 12 between 0° and 90°.
图5(a)为本发明实施例中的支撑杆和弹簧圈式过渡件的结构示意图;图5(b)为本发明的支撑杆和胶水式过渡件的结构示意图。FIG. 5( a ) is a structural schematic view of a support rod and a spring coil transition piece according to an embodiment of the present invention; and FIG. 5( b ) is a structural schematic view of the support rod and the glue type transition piece of the present invention.
请参见图5(a)和图5(b),其显示了第一腔中用于调节螺旋圈所需的支撑杆24以及过渡件27,其中支撑杆24为具备一定硬度并具备一定形状记忆功能的金属棒,如不锈钢材质以及NITI丝等,其直径在0.20-0.5mm之间,优选的为0.35mm,过渡件27为弹簧圈,如图5(a)所示,其可通过焊接的方式连接在支撑杆24上,弹簧圈的末端弹簧帽与磨细的支撑杆24远端末焊接在一起,以避免支撑杆24在推送的过程中戳出弹簧圈,为了进一步加强减小摩擦阻力的效果,支撑杆24外层还可以涂覆有一层亲水爽滑涂层。Referring to FIG. 5(a) and FIG. 5(b), thesupport rod 24 and thetransition piece 27 required for adjusting the spiral ring in the first cavity are shown, wherein thesupport rod 24 has a certain hardness and has a certain shape memory. Functional metal rods, such as stainless steel and NITI wire, have diameters between 0.20 and 0.5 mm.Preferably, thetransition piece 27 is a spring ring, as shown in Fig. 5(a), which can be welded to thesupport rod 24, and the end spring cap of the spring ring and the distal end of theground support rod 24 They are welded together to prevent thesupport rod 24 from punctuating the coil during the pushing process. To further enhance the effect of reducing the frictional resistance, the outer layer of thesupport rod 24 may also be coated with a hydrophilic smooth coating.
过渡件27的另一实施例如图5(b)所示,其材质为环氧树脂等晾干后具备一定爽滑性的胶水层,其可以仅覆盖于支撑杆24远端末,也可以覆盖于整个支撑杆24上。Another embodiment of thetransition piece 27 is, as shown in FIG. 5(b), which is made of an epoxy resin or the like, which has a certain smoothness after drying, and may cover only the distal end of thesupport rod 24 or may be covered. Theentire support rod 24 is on.
由于第四腔在设计时候本身附带有一层爽滑涂层23,故此设计可以减少将螺旋段推直的摩擦阻力以及可能造成的破腔等情况发生。Since the fourth chamber is designed with asmooth coating 23 attached thereto, the design can reduce the frictional resistance of the spiral section and the possible breakage of the cavity.
综上,本发明提供的肾动脉射频消融电极导管,通过手把15控制导管远端消融段即导管螺旋段12在螺旋状和直行状切换,并同时通过手把15控制整个导管螺旋段12在0°-90°之间偏转,达到易于手术过程中导管进入目标血管进行射频消融的目的,从而简化肾动脉射频手术,以及简化螺旋多腔管内部组件。In summary, the present invention provides a renal artery radiofrequency ablation electrode catheter, which is controlled by ahandle 15 to control the distal ablation section of the catheter, that is, thecatheter spiral section 12 is switched in a spiral shape and a straight line shape, and simultaneously controls the entirecatheter spiral section 12 through thehandle 15 Deflection between 0° and 90° achieves the goal of facilitating radiofrequency ablation of the catheter into the target vessel during surgery, thereby simplifying renal artery RF surgery and simplifying the internal components of the spiral multi-lumen tube.
虽然本发明已以较佳实施例揭示如上,然其并非用以限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,当可作些许的修改和完善,因此本发明的保护范围当以权利要求书所界定的为准。While the present invention has been described in its preferred embodiments, the present invention is not intended to be limited thereto, and the present invention may be modified and improved without departing from the spirit and scope of the invention. The scope of protection is defined by the terms of the claims.