技术领域technical field
本发明涉及一种动脉血管介入(造影或支架治疗)的插管及诱导技术，特别涉及一种用于肾脏动脉血管介入的插管及诱导装置。The invention relates to a catheterization and induction technology for arterial intervention (radiography or stent treatment), in particular to a catheterization and induction device for renal arterial intervention.
背景技术Background technique
随着物质生活水平的不断提高，生活方式的多样化，粥样性硬化血管病发病率越来越高，而血管狭窄引起的冠心病、肾病已经成为危及人类生命健康的主要疾病之一。粥样硬化性肾动脉狭窄的特点表现在：15％患者5年内可发展为完全闭塞；10-20﹪的患者5年内肾功能将逐渐恶化。因此，每年有5-15﹪的患者可发展为终末期肾脏病变，经透析治疗终末期肾脏病变3年死亡率高达50﹪。目前，心血管病的治疗技术已相当成熟，特别是用血管支架介入治疗技术挽救了无数冠心病患者的生命，取得了令人瞩目的疗效。而肾动脉狭窄的介入治疗目前只是从髂动脉、肱动脉插管来达到目的。但是，这两条动脉都分布在各自部位的深层，难穿刺、难止血，在介入过程中存在着一定的难度和风险，也对患者在治疗后康复时间上没有保证。同样，心脏动脉插管经过数十年的应用，也逐渐暴露出它的不足和弊端，如不同的狭窄位置要从不同的位置插管，遇见血管拐弯时要插的管子就很难进入，有可能造成再狭窄，并且，多途径插管也有许多不足，比如，胫骨动脉置鞘插管压迫止血较为困难，病人需要平躺时间过长，已出现局部血肿、假性动脉瘤、动静脉瘘及腹膜后血肿。尽管有闭合设备，但价格较为昂贵且对部分病人效果并不好。为了克服以上弊端，我们对几种动脉插管部位的特点进行了总结，依据人体血管分布特征，根据区域神经分布的多少，结合临床现状，提出一种以经桡动脉到肾动脉介入为主的插管及诱导装置。With the continuous improvement of material living standards and diversification of lifestyles, the incidence of atherosclerotic vascular disease is increasing, and coronary heart disease and kidney disease caused by vascular stenosis have become one of the main diseases that threaten human life and health. The characteristics of atherosclerotic renal artery stenosis are as follows: 15% of patients can develop into complete occlusion within 5 years; 10-20% of patients will gradually deteriorate their renal function within 5 years. Therefore, 5-15% of patients may develop end-stage renal disease every year, and the 3-year mortality rate of end-stage renal disease after dialysis treatment is as high as 50%. At present, the treatment technology of cardiovascular disease is quite mature, especially the interventional treatment technology of vascular stent has saved the lives of countless patients with coronary heart disease, and achieved remarkable curative effect. However, the interventional treatment of renal artery stenosis is currently achieved only through catheterization of the iliac artery and brachial artery. However, these two arteries are distributed in the deep layers of their respective parts, which are difficult to puncture and stop bleeding. There are certain difficulties and risks in the intervention process, and there is no guarantee for the patient's recovery time after treatment. Similarly, after decades of application of cardiac artery cannulation, its shortcomings and drawbacks have gradually been exposed. For example, different stenosis positions need to be intubated from different positions, and it is difficult to enter the tube to be inserted when the blood vessel turns. It may cause restenosis, and multi-channel intubation also has many disadvantages. For example, it is difficult to stop bleeding by sheathing and intubating the tibial artery, the patient needs to lie down for too long, local hematoma, pseudoaneurysm, arteriovenous fistula and Retroperitoneal hematoma. Although closure devices are available, they are expensive and do not work well for some patients. In order to overcome the above drawbacks, we summarized the characteristics of several arterial intubation sites, based on the distribution characteristics of human blood vessels, according to the distribution of regional nerves, and combined with the clinical situation, we proposed a method of intervention mainly through the radial artery to the renal artery. Intubation and induction devices.
发明内容Contents of the invention
本发明的目的是提供一种具有超弹性功能的肾动脉介入插管及诱导装置，以实现粥样硬化性肾动脉狭窄患者科学、安全、方便快捷的进行介入治疗，解决其疾病痛苦。The purpose of the present invention is to provide a renal artery interventional cannula and induction device with superelastic function, so as to realize scientific, safe, convenient and quick interventional treatment for patients with atherosclerotic renal artery stenosis, and relieve their pain.
为达到以上目的，本发明是采取如下技术方案予以实现的：To achieve the above object, the present invention is achieved by taking the following technical solutions:
一种以经桡动脉至肾动脉介入为主的插管及诱导装置，包括一个长度大于1.2m的导管、一个长度略大于导管长度的导丝，导管后端设有一个三通分别连通药物支管、导管进口；其特征在于，所述导丝为一种金属记忆型镍钛合金丝，其从导管进口穿入导管中至导管出口穿出，导丝头部设有与导丝直径相等的半圆球；所述穿入导管中的导丝上等间隔设有多个凸起的结点，各结点间均设有一个阻挡栓，阻挡栓的后端设有由三个小枝杆组成三爪撑，该三爪撑构成材料为镍钛合金，室温时，三个小枝杆紧贴阻挡栓外壁与导丝轴向平行，使导丝可顺利穿入导管中；当导丝及导管进入血管后，在人体体温的加热作用下，三个小枝杆受热变形，其前部自由端张开，直至贴住导管内壁，这时，由于三爪撑的倒刺作用，阻挡栓在导管中被顺向固定，不能前行，导丝通过结点及阻挡栓，只能前后活动一小段距离h，h小于结点间距；由于三爪撑的顺刺作用，阻挡栓在导管中不能被逆向固定，当导丝需要后退时，通过结点及与导管分离的阻挡栓可单独全部退出。An intubation and induction device mainly for intervention from the radial artery to the renal artery, including a catheter with a length greater than 1.2m, a guide wire with a length slightly longer than the catheter, and a three-way connection to the drug branch at the rear end of the catheter , catheter inlet; it is characterized in that, described guide wire is a kind of metal memory type nickel-titanium alloy wire, and it penetrates in the catheter from catheter inlet to catheter outlet and passes out, and the guide wire head is provided with the semicircle that is equal to the diameter of guide wire ball; the guide wire penetrating into the catheter is provided with a plurality of protruding nodes at equal intervals, and a blocking plug is arranged between each node, and the rear end of the blocking plug is provided with three claws composed of three twigs. The three-claw support is made of nickel-titanium alloy. At room temperature, the three twigs are close to the outer wall of the blocking plug and parallel to the axial direction of the guide wire, so that the guide wire can smoothly penetrate into the catheter; when the guide wire and catheter enter the blood vessel , under the heating effect of human body temperature, the three twigs are heated and deformed, and the free ends of their front parts are opened until they stick to the inner wall of the catheter. Fixed, unable to move forward, the guide wire passes through the node and the blocking plug, and can only move forward and backward for a short distance h, h is smaller than the distance between the nodes; due to the puncturing effect of the three-claw support, the blocking plug cannot be fixed in reverse in the catheter, when When the guide wire needs to be retracted, the blocking plug passing through the node and separated from the catheter can all be withdrawn independently.
上述方案中，所述导丝末端设有一个可拆卸的旋转手柄，导管进口的外周设有360度刻度线。In the above solution, a detachable rotating handle is provided at the end of the guide wire, and a 360-degree scale line is provided on the outer periphery of the catheter inlet.
所述结点间距为20cm。所述导丝穿出导管出口的部分约15cm。所述导丝末端与加热器相连。The distance between the nodes is 20cm. The guidewire passes approximately 15 cm past the catheter exit portion. The end of the guide wire is connected with a heater.
本发明的优点是，在其介入过程中，采用超强弹性及奇特的形状记忆导丝可明显降低进入血管的难度，快速准确到达病灶点。导丝头部设有与导丝直径相等的半圆球，可保障导丝插入血管后不会对患者血管壁造成再损伤。The advantage of the present invention is that, during the intervention process, the use of a super-elastic and peculiar shape-memory guide wire can significantly reduce the difficulty of entering blood vessels, and quickly and accurately reach the lesion point. The head of the guide wire is equipped with a hemisphere equal to the diameter of the guide wire, which can ensure that the guide wire will not cause further damage to the patient's blood vessel wall after being inserted into the blood vessel.
穿入导管中的导丝上采用三爪撑、结点以及阻挡栓的组合结构，可使导丝在冷态顺利穿入导管中；当进入血管后，由于体温加热作用使三爪撑张开，可保证导丝在前行时与导管同行。当导丝需要后退时，由于三爪撑的顺刺作用，阻挡栓在导管中不能被逆向固定，故导丝通过结点及与导管分离的阻挡栓可单独全部退出，从而可保证导丝进入血管时具有更高的示踪性和灵活性。The guide wire that penetrates into the catheter adopts a combined structure of three claws, nodes and blocking plugs, so that the guide wire can smoothly penetrate into the catheter in a cold state; when it enters the blood vessel, the three claws are opened due to the heating effect of body temperature , which can ensure that the guide wire goes with the catheter when it moves forward. When the guide wire needs to go back, due to the puncture function of the three-claw support, the blocking plug cannot be reversely fixed in the catheter, so the guide wire passes through the node and the blocking plug separated from the catheter can all be withdrawn independently, thus ensuring the guide wire to enter Higher traceability and flexibility in blood vessels.
附图说明Description of drawings
以下结合附图及具体实施方式对本发明作进一步的详细描述。The present invention will be described in further detail below in conjunction with the accompanying drawings and specific embodiments.
图1是本发明装置的结构示意图。Fig. 1 is a structural schematic diagram of the device of the present invention.
图2是图1中Z部放大图(导管内导丝的结构)。其中：b图是a图的A-A向剖视图。Fig. 2 is an enlarged view of part Z in Fig. 1 (the structure of the guide wire in the catheter). Wherein: Figure b is an A-A sectional view of Figure a.
图1、图2中，1、导丝；2、导管进口；3、旋转手柄；4、药物支管；5、三通；6、导管；7、导管出口；8、阻挡栓；9、三爪撑；10结点。In Fig. 1 and Fig. 2, 1. Guide wire; 2. Catheter inlet; 3. Rotary handle; 4. Drug branch; 5. Tee; 6. Catheter; 7. Catheter outlet; brace; 10 knots.
具体实施方式detailed description
参考图1，一种以经桡动脉至肾动脉介入为主的插管及诱导装置，包括一个长度为1.2-1.6m的导管6、一条金属记忆型导丝1，导管后端有一个三通5分别连通药物支管4、导管进口2；导管进口的外周设有360度刻度线。导丝从导管进口2穿入导管中至导管出口7穿出，穿出部分约15cm，导丝头部设有与导丝直径相等的半圆球；其作用是减少导丝插入血管后对患者血管壁造成的再损伤。导管2采用已商业化的现有动脉插管(如现有常用技术中的聚氨酯树脂表面腹膜亲水性聚合物导管)；导丝1采用镍钛(TiNi)合金制成，如型号为Q/XB1516、Q/XB1520的TiNi-01合金丝，其相变温度范围为20度-40度就特别适合。与以往的钢丝不同，TiNi合金是一种记忆功能材料，除具有强度高、耐磨、耐蚀、耐腐蚀、无磁、生物相容性好等特点外，还具有超强弹性(抗拉强度为850MPa,屈服强度为195-690MPa,延伸率可达到25-50％)及形状记忆性能。因此，在其介入过程中，可明显降低进入血管的难度，快速准确到达病灶点。Referring to Fig. 1, an intubation and induction device for intervening from the radial artery to the renal artery mainly includes a catheter 6 with a length of 1.2-1.6 m, a metal memory guide wire 1, and a tee at the rear end of the catheter 5 are respectively connected to the drug branch pipe 4 and the catheter inlet 2; the outer circumference of the catheter inlet is provided with a 360-degree scale line. The guide wire is inserted into the catheter from the catheter inlet 2 to the catheter outlet 7. The part that passes through is about 15 cm. The head of the guide wire is provided with a hemisphere equal to the diameter of the guide wire; its function is to reduce the impact on the patient's blood vessel after the guide wire is inserted re-injury to the wall. Catheter 2 adopts commercialized existing arterial cannula (such as polyurethane resin surface peritoneal hydrophilic polymer catheter in the existing common technology); guide wire 1 is made of nickel-titanium (TiNi) alloy, such as model Q/ The TiNi-01 alloy wire of XB1516 and Q/XB1520 is especially suitable for the phase transition temperature range of 20°C to 40°C. Different from the previous steel wires, TiNi alloy is a kind of memory functional material. In addition to the characteristics of high strength, wear resistance, corrosion resistance, corrosion resistance, non-magnetism, and good biocompatibility, it also has super elasticity (tensile strength It is 850MPa, yield strength is 195-690MPa, elongation can reach 25-50%) and shape memory performance. Therefore, during the intervention process, the difficulty of entering blood vessels can be significantly reduced, and the focus point can be reached quickly and accurately.
导丝末端还可选择与加热器相连，这样可通过加热变形进一步增加导丝的记忆及弹性，以适应介入复杂途径血路的需要(如血管拐弯等)。The end of the guide wire can also be optionally connected to a heater, which can further increase the memory and elasticity of the guide wire through heating and deformation, so as to meet the needs of intervening in complex blood routes (such as blood vessel bends, etc.).
导丝末端设有一个可拆卸的旋转手柄3，用时该旋转手柄与导丝末端对接为一体，不用时可卸下分别保存。该旋转手柄的功能是，当导丝插入血管后，配合导管进口外周的刻度线，便于导丝进入血管狭窄处时能准确微调导丝的径向角度，并直观显示导丝旋转角度，缩短介入治疗时间。The end of the guide wire is provided with a detachable rotary handle 3, which is integrated with the end of the guide wire when in use, and can be removed and stored separately when not in use. The function of the rotating handle is that when the guide wire is inserted into the blood vessel, it cooperates with the scale line on the outer periphery of the catheter inlet, so that the radial angle of the guide wire can be accurately fine-tuned when the guide wire enters the stenosis of the blood vessel, and the rotation angle of the guide wire can be displayed intuitively, shortening the intervention time. Treatment time.
参考图2，穿入导管中的导丝上每间隔20cm设有一个凸起的结点10，各结点间均设有一个阻挡栓8，阻挡栓8的后端设有可张开的三爪撑9。该三爪撑9由三个小枝杆组成，它们张开时，三个小枝杆径向之间夹角均为120°(图2b)。三爪撑构成材料为与导丝同类的TiNi合金，其冷态(室温)时，三个小枝杆紧贴阻挡栓外壁与导丝轴向平行，使导丝可顺利穿入导管中。当导丝及导管进入动脉血管后，在人体体温(37℃)的加热作用下，三个小枝杆受热变形，其前部自由端张开，直至贴住导管内壁，这时，由于三爪撑的倒刺作用，阻挡栓在导管中被顺向固定，不能前行，导丝通过结点及阻挡栓8，只能前后活动一小段距离h(h＜20cm)，这样可保证导丝在前行时与导管同行。当导丝需要后退时，由于三爪撑的顺刺作用，阻挡栓在导管中不能被逆向固定，故导丝通过结点及与导管分离的阻挡栓8可单独全部退出，从而可保证导丝进入血管时具有更高的示踪性和灵活性。Referring to Fig. 2, a raised node 10 is arranged at intervals of 20 cm on the guide wire inserted into the catheter, and a blocking plug 8 is arranged between each node, and the rear end of the blocking plug 8 is provided with three expandable Claw support9. The three-claw support 9 is composed of three twigs, and when they are opened, the radial angles between the three twigs are all 120° (Fig. 2b). The three-claw brace is made of the same TiNi alloy as the guide wire. When it is cold (at room temperature), the three twigs are close to the outer wall of the blocking plug and parallel to the guide wire axis, so that the guide wire can be smoothly inserted into the catheter. After the guide wire and catheter enter the arterial vessel, under the heating effect of human body temperature (37°C), the three twigs are heated and deformed, and the free ends of their front parts are opened until they stick to the inner wall of the catheter. The barb effect, the blocking plug is fixed forward in the catheter and cannot move forward. The guide wire can only move forward and backward for a small distance h (h<20cm) through the node and the blocking plug 8, so that the guide wire can be guaranteed to move forward and backward. Travel with the catheter. When the guide wire needs to be moved back, due to the stabbing effect of the three-claw support, the blocking plug cannot be reversely fixed in the catheter, so the guide wire passes through the node and the blocking plug 8 that is separated from the catheter can all be withdrawn independently, thereby ensuring that the guide wire It has higher traceability and flexibility when entering blood vessels.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510151895.3ACN104771824B (en) | 2015-04-01 | 2015-04-01 | Intubation and induction devices based on intervention from the radial artery to the renal artery |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510151895.3ACN104771824B (en) | 2015-04-01 | 2015-04-01 | Intubation and induction devices based on intervention from the radial artery to the renal artery |
| Publication Number | Publication Date |
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| CN104771824A CN104771824A (en) | 2015-07-15 |
| CN104771824Btrue CN104771824B (en) | 2017-08-04 |
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| CN201510151895.3AExpired - Fee RelatedCN104771824B (en) | 2015-04-01 | 2015-04-01 | Intubation and induction devices based on intervention from the radial artery to the renal artery |
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