WO2022000178A1 - 电极导管系统 - Google Patents

电极导管系统 Download PDF

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Publication number
WO2022000178A1
WO2022000178A1 PCT/CN2020/098897 CN2020098897W WO2022000178A1 WO 2022000178 A1 WO2022000178 A1 WO 2022000178A1 CN 2020098897 W CN2020098897 W CN 2020098897W WO 2022000178 A1 WO2022000178 A1 WO 2022000178A1
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WIPO (PCT)
Prior art keywords
electrode
catheter
catheter system
interventional catheter
electrode element
Prior art date
Application number
PCT/CN2020/098897
Other languages
English (en)
French (fr)
Inventor
丁毅寿
张喜博
张昱昕
钱俊
黄晶
蒲忠杰
Original Assignee
乐普（北京）医疗器械股份有限公司
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Publication date
Application filed by 乐普（北京）医疗器械股份有限公司 filed Critical 乐普（北京）医疗器械股份有限公司
Priority to EP20803731.7A priority Critical patent/EP3960106B1/en
Priority to ES20803731T priority patent/ES2947179T3/es
Priority to PCT/CN2020/098897 priority patent/WO2022000178A1/zh
Priority to US17/056,690 priority patent/US20210401454A1/en
Publication of WO2022000178A1 publication Critical patent/WO2022000178A1/zh

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Definitions

  • the present invention relates to the technical field of interventional therapy, in particular to an electrode catheter system.
  • radiofrequency ablation catheters provide a good idea for the treatment of refractory hypertension, and the safety and effectiveness of the treatment have been preliminarily verified, the patient's neurological activity needs to be screened. If it is not enough, this operation cannot be used for treatment, and after the operation in the prior art, it is difficult for the ultrasonic ablation catheter system to evaluate the surgical effect of denervation before and after the operation, and it is difficult to judge whether it needs to be repeated according to the patient's condition. Perform ablation.
  • the purpose of the present invention is to provide an electrode catheter system to solve the technical problem in the prior art that it is difficult to evaluate preoperative and postoperative surgical effects.
  • the technical solution adopted in the present invention is to provide an electrode catheter system, including an intervention catheter that can be inserted into one renal artery blood vessel, a pressure sensor that can be inserted into the arterial blood vessel; and a data processing module.
  • the interventional catheter is provided with electrode elements capable of releasing electrical signals toward the inner wall of the renal artery vessel; the pressure sensor is connected with the data processing module.
  • ECG detection module for monitoring heartbeat
  • the ECG monitoring module is connected with the data processing module.
  • the pressure sensor is placed in the renal artery on the other side.
  • the electrode element is made of elastic metal material, and the electrode element has a first state of being accommodated in the interventional catheter, and a second state of being attached to the inner wall of the renal artery vessel.
  • a control wire and a first guide wire cavity for accommodating the control wire are arranged in the interventional catheter, the electrode element is connected with the control wire, and the control wire moves in the first guide wire under the action of an external force.
  • a guide wire slides inside the lumen.
  • the electrode element is pre-shaped into an arc shape, and both ends of the electrode element are fixedly connected to the control wire.
  • the electrode element is pre-shaped into a spiral ring shape, and one end of the electrode element is fixedly connected with the control wire.
  • an ablation element is further provided on the interventional catheter, the ablation element is located at the distal end of the interventional catheter, and the electrode element is located at the proximal end of the ablation element.
  • the ablation element includes a balloon and an ultrasonic transducer arranged in the balloon, and the balloon is fixed to the distal end of the interventional catheter.
  • a second guide wire cavity and a guide wire are arranged in the interventional catheter, a transducer placement platform is arranged on the outer edge of the second guide wire cavity in the balloon, and the ultrasonic transducer is fixed on the outer edge of the balloon.
  • the transducer is placed on a table, and the ultrasonic transducer is connected to the wire.
  • a water inlet cavity and a water outlet cavity are also arranged in the interventional catheter, and both the water inlet cavity and the water outlet cavity are communicated with the balloon.
  • the proximal end of the interventional catheter is also provided with a handle, and the handle is provided with a control button for controlling the electrode element.
  • the electrode element By inserting an electrode element into the renal artery, the electrode element releases electrical signals toward the inner wall of the renal artery, and then a pressure sensor is inserted into other arteries except the renal artery on the side, and the blood pressure changes are monitored through the pressure sensor.
  • the data processing module processes the monitoring data of the pressure sensor and judges the blood pressure change, and judges the activity of the nerve by detecting the blood pressure signal of the human body, so as to screen out the patients with overactive sympathetic nerve. The surgical effect of the surgery was evaluated and a decision was made whether ultrasound ablation was needed again.
  • the heart rate of the human body is monitored by the ECG monitoring module, and the activity of the nerve is judged jointly by the change of the heart rate of the human body after the electrode element is energized and the blood pressure change, and the monitoring accuracy is higher.
  • the electrode element is made of elastic material, which can control the contraction or expansion of the control element outside the human body. Under normal conditions, it is stored inside the interventional catheter. After being placed inside the human body, it can elastically fit inside the blood vessel. The size of the blood vessel is controlled in a simple manner, and can be brought into the body by an interventional catheter, causing less damage to the human body.
  • An ablation element is set at the front end of the interventional catheter, which can combine ablation and detection. Only one interventional catheter is needed to achieve preoperative screening, ultrasonic ablation and postoperative detection, and it is also possible to detect unsuccessful denervation after surgery. Continuous ultrasound ablation is convenient to use and may cause less damage to the human body.
  • FIG. 1 is a schematic structural diagram of the electrode catheter system provided in Embodiment 1 of the present invention, wherein the electrode elements extend out of the interventional catheter;
  • FIG. 2 is a schematic structural diagram of the electrode catheter system provided in Embodiment 1 of the present invention, wherein the electrode elements are accommodated in the interventional catheter;
  • FIG. 3 is a schematic structural diagram of an interventional catheter adopted in Embodiment 1 of the present invention.
  • Fig. 4 is a partial enlarged cross-sectional view of part A in Fig. 3;
  • Fig. 5 is a sectional structural view along the direction B-B in Fig. 3;
  • FIG. 6 is a schematic structural diagram of an interventional catheter used in Embodiment 2 of the present invention.
  • Interventional catheter 2. Pressure sensor; 3. ECG monitor; 4. Handle; 5. Renal artery vessel; 11. Ablation element; 12. Electrode element; 13. First guide wire lumen; 14. Second guide silk cavity; 15, water inlet cavity; 16, water outlet cavity; 121, control wire; 111, balloon; 112, ultrasonic transducer; 41, control button.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • proximal end and distal end are the relative orientation, relative position and relative orientation of elements or actions relative to each other from the perspective of the physician using the medical device, although “proximal end” and “distal end” are “Distal” is not limiting, but “proximal” generally refers to the end of the medical device that is closest to the physician during normal operation, and “distal” generally refers to the end that first enters the patient.
  • the electrode catheter system includes an interventional catheter 1, a pressure sensor 2 and a data processing module (not shown), the interventional catheter 1 can be inserted into one renal artery vessel 5, and the distal end of the interventional catheter 1 is provided with an ablation element 11, The proximal side of the ablation element 11 is provided with an electrode element 12, the electrode element 12 can release electrical signals toward the inner wall of the renal artery vessel 5, and the pressure sensor 2 located in other arterial vessels 5 can detect the pressure in the vessel in real time, that is, The blood pressure is detected, and the detected pressure in the blood vessel is converted into blood pressure through the data processing module, so that the activity of the nerve can be judged by the blood pressure.
  • the data processing module can be a data processor of a conventional blood pressure instrument in the prior art, which can convert the value of the pressure sensor 2 placed inside the blood vessel into the blood pressure value of the human body, and the data processing module can directly determine whether the blood pressure exceeds a certain value.
  • a threshold is used to judge whether the activity of the nerve is too high, and the blood pressure change value can also be directly fed back to a screen.
  • the pressure sensor 2 is placed in any other blood vessel except the renal artery blood vessel 5 in which the interventional catheter is placed, so as to prevent the electrode signal of the electrode element 12 from interfering with the measurement.
  • the pressure sensor 2 is located in the renal artery on the other side, which is convenient for operation and more accurate in measurement results during surgery.
  • an ECG monitoring module 3 can be added, and the nerve activity can be judged in combination with the heart rate changes monitored by the ECG monitoring module 3 .
  • the ECG monitoring module 3 can be the ECG monitoring module 3 conventionally used in the prior art, the ECG monitoring module 3 is connected in communication with the data processing module, and the heart rate detected by the ECG monitoring module 3 can be received through the data processing module, The data processing module can directly judge whether the heart rate exceeds a certain threshold, so as to draw a conclusion whether the activity of the nerve is too high, or it can directly feed back the heart rate change value on a screen, and the operator can combine the change rules of heart rate and blood pressure. The conclusion of whether the activity of the nerve is too high is comprehensively obtained, which is not limited here.
  • the specific criterion for judging nerve activity is the prior art.
  • the activity of the nerve can be judged by detecting the blood pressure signal of the human body, and it can also be combined with information such as heart rate for auxiliary judgment, so as to screen out patients with overactive sympathetic nerves, which can also be used in surgery.
  • the surgical effect of denervation was evaluated before or after surgery, and a decision was made whether repeat ultrasound ablation was required.
  • the electrical signal is released by the electrode element 12 toward the renal artery vessel 5 on one side;
  • the heart rate is monitored by the ECG monitor 3, and the blood pressure change in the renal artery 5 on the other side is monitored by the pressure sensor 2, and the patient's neural activity is judged by judging whether the heart rate and blood pressure changes reach the threshold;
  • the patient's heart rate and blood pressure changes are lower than the thresholds, the patient's nerve activity is insufficient, and the hypertension caused by sympathetic nerve overexcitation is excluded, and other methods need to be treated;
  • the patient's nerve activity is strong, and the hypertension may be caused by the overexcitation of the sympathetic nerve, and the patient needs to be treated by ultrasound ablation.
  • the electrical signal is released by the electrode element 12 toward the renal artery vessel 5 on one side;
  • the heart rate is monitored by the ECG monitor 3, and the blood pressure change in the renal artery 5 on the other side is monitored by the pressure sensor 2, and the patient's neural activity is judged by judging whether the heart rate and blood pressure changes reach the threshold;
  • the patient's nerve activity has been reduced to the standard value, which proves that the operation has a good effect, and the treatment can be ended;
  • the above methods can be used to evaluate the surgical effect of denervation before or after surgery, and decide whether to perform ultrasonic ablation again.
  • the pressure sensor 2 can be a pressure sensor 2 in the prior art that can be placed in a human blood vessel to measure the intravascular pressure
  • the ECG monitor 3 can also be a conventional ECG monitoring device in the prior art.
  • the pressure sensor 2 and the ECG monitor 3 can be connected to a controller together, and the detected results can be processed and analyzed in a unified manner through the controller, and the detected values can also be displayed separately, and the operator can check the results according to the detection results.
  • the value of which is not uniquely limited here.
  • the electrode element 12 is made of elastic metal material, and the electrode element 12 can be driven by the control wire 121. It is stored in the interventional catheter 1 , or is attached to the inner wall of the renal artery vessel 5 under the driving of the control wire 121 .
  • the control wire 121 is arranged inside the interventional catheter 1, and the interventional catheter 1 is a multi-lumen catheter.
  • the interventional catheter 1 is provided with a first guide wire lumen 13 for accommodating the control wire 121.
  • the control wire 121 can be inserted in the first guide wire.
  • the wire cavity 13 slides.
  • the electrode element 12 may use other elastic and conductive materials, such as conductive foam, which is not limited here.
  • the handle 4 is located at the proximal end of the interventional catheter 1 , which is convenient for the operator to hold and control the interventional catheter 1 .
  • the handle 4 is provided with a control button 41.
  • the control button 41 can control the expansion and contraction of the control wire 121.
  • One end of the control wire 121 enters the renal artery vessel 5 through the first guide wire cavity 13, and the other end can be connected through the interventional catheter 1. to the external handle 4 , so that the control wire 121 can be controlled externally, and then the retraction and retraction of the electrode element 12 can be controlled.
  • the control button 41 can not only control the movement of the control wire 121 along the length direction of the interventional catheter 1 , but also control the rotation of the control wire 121 along the circumferential direction of the interventional catheter 1 .
  • the handle 4 may also be provided with other control buttons (not shown), such as a control button for controlling the power on and off of the electrode element 12 or the ablation element 11, and the control button can be connected with a wire , and control the on-off of the wire.
  • buttons such as a control button for controlling the power on and off of the electrode element 12 or the ablation element 11, and the control button can be connected with a wire , and control the on-off of the wire.
  • an electrode wire is generally used directly for the electrode element 12, and the electrode wire is pre-shaped into an arc shape or a circular shape, and both ends of the electrode wire are free ends, and the electrode wire is Both ends are directly fixed or integrally formed with the control wire 121, and the electrode wire can move along the length of the interventional catheter 1 under the driving of the control wire 121, so that the electrode wire can move in the interventional catheter 1 without entering the predetermined Before the position, the electrode element 12 is compressed and accommodated inside the interventional catheter 1 to avoid additional damage; after entering the predetermined position, the control wire 121 drives the electrode element 12 to move toward the distal end, and the electrode element 12 can be opened and closed.
  • the control wire 121 drives the electrode element 12 to move toward the proximal end, and the electrode element 12 can be retracted and accommodated inside the interventional catheter 1 again.
  • the electrode element 12 can also be pre-shaped into a square or a triangle, etc., which is not limited here.
  • the interventional catheter 1 is further provided with an ablation element 11
  • the ablation element 11 refers to a device that can perform ultrasonic ablation in an ablation operation.
  • the ablation element 11 is located at the distal end of the interventional catheter 1
  • the electrode element 12 is located at the proximal end of one side of the ablation element 11
  • both the electrode element 12 and the ablation element 11 are located inside the renal artery vessel 5 .
  • the ablation element 11 includes a balloon 111 and an ultrasonic transducer 112 arranged in the balloon 111.
  • the balloon 111 is sleeved on the interventional catheter 1 and fixed to the distal end of the interventional catheter 1.
  • the balloon 111 can be inflated after being injected with liquid or gas, and covers the outside of the ultrasonic transducer 112 , and protects the ultrasonic transducer 112 to prevent the ultrasonic transducer 112 from directly contacting the human body.
  • the ultrasonic transducer 112 can be a conventional ultrasonic transducer 112 capable of realizing ultrasonic ablation in the prior art, and one or more ultrasonic transducers 112 can be provided as required.
  • the interventional catheter 1 is a multi-lumen catheter.
  • the interior of the interventional catheter 1 has multiple chambers, and the interior of the interventional catheter 1 has a first guide wire cavity 13, a second guide wire cavity 14, a water inlet cavity 15 and a water outlet cavity 16, wherein the first guide wire cavity 16.
  • 13 is used to pass through the control wire 121, and its length is extended from the handle 4 to the control wire 121;
  • the second guide wire cavity 14 is used for other operation guide wires to pass through, which generally runs through the entire interventional catheter 1, into the water cavity 15
  • Both the water inlet chamber 15 and the water outlet chamber 16 communicate with the balloon 111.
  • Cold water can pass through the water inlet chamber 15 and the water outlet chamber 16.
  • the proximal end of the water inlet chamber 15 is connected to a pressurized syringe containing cold water.
  • the distal end of the water inlet cavity 15 is connected with the balloon 111, and a plurality of water outlets are opened on the side wall of the distal part, and the water outlets are communicated with the balloon 111.
  • the inside of the balloon 111 is filled with cold water.
  • cold water can flow out from the water outlet cavity 16 to the outside of the human body, so that the cold water in the balloon 111 can be circulated, and when the ultrasonic ablation is completed, the cold water can be completely discharged from the water outlet cavity 16, which can effectively prevent the ultrasonic transducer 112 from being damaged.
  • the temperature is too high during use.
  • the interventional catheter 1 is also provided with a lead (not shown in the figure), which can provide electrical energy for the ultrasonic transducer 112 and the electrode element 12, and the lead can be directly located inside the interventional catheter 1, or can be accommodated in the second guide wire cavity 14 or other chamber interior.
  • a lead (not shown in the figure), which can provide electrical energy for the ultrasonic transducer 112 and the electrode element 12, and the lead can be directly located inside the interventional catheter 1, or can be accommodated in the second guide wire cavity 14 or other chamber interior.
  • the inner distal end of the balloon 111 only has a second guide wire cavity 14 , and the outer edge of the second guide wire cavity 14 is directly provided for the ultrasonic transducer 112 to be fixed.
  • the transducer placement table (not shown in the figure), the wire can be passed through the inside of the second guide wire cavity 14 and connected to the ultrasonic transducer 112 through the transducer placement table.
  • the transducer placement table can also be a conventional transducer placement table in the prior art.
  • the interventional catheter 1 When in use, the interventional catheter 1 is placed in the renal artery 5 of the patient, and the blood pressure changes and the heart rate in the renal artery 5 on the other side are monitored at the same time.
  • the control button controls the control wire 121 to move along the length direction of the interventional catheter 1
  • the control wire 121 drives the electrode element 12 to move towards the distal end
  • the electrode element 12 is released and expanded under the action of elasticity until the electrode element 12 abuts against the renal artery vessel.
  • control electrode element 12 releases electrical signals, and if the conditions for ultrasonic ablation are met, water is injected into the balloon 111 through the water inlet and water is returned through the water outlet to realize water circulation, and the ultrasonic transducer 112 starts to perform ultrasonic ablation.
  • the ultrasonic ablation work is completed, the ultrasonic transducer 112 is stopped, and water injection into the balloon 111 is stopped, and the water in the balloon 111 flows out from the water outlet; the control wire 121
  • the electrode element 12 is driven to move toward the proximal end, and the electrode element 12 is compressed under the action of the inner wall of the interventional catheter 1 , and uses its elastic energy to abut against the inner wall of the interventional catheter 1 .
  • the difference between this embodiment and Embodiment 1 is that the electrode element 12 is pre-shaped into a spiral ring, and one end of the electrode element 12 It is fixedly connected with the control wire 121 .
  • the electrode element 12 is still an electrode wire, which is pre-shaped into a spiral ring shape, and the electrode wire also has two free ends, one of which is directly fixedly connected with the control wire 121 or integrally formed, and the other free end is located at the control wire 121. remote.
  • the control wire 121 can move along the length of the interventional catheter 1 inside the first guidewire lumen 13, and can rotate around the circumference of the interventional catheter 1, so as to gradually release the electrode wire to the outside of the interventional catheter 1 and connect with the renal artery.
  • the inner wall of the blood vessel 1 is in contact with the inner wall of the renal artery vessel 1 .
  • the abutment surface and abutment range of the electrode wire and the inner wall of the renal artery vessel 1 are larger.
  • the shape of the electrode element 12 may also be a spiral ellipse, a spiral triangle, etc., which are not limited here.

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Abstract

一种电极导管系统，包括可介入至一侧肾动脉血管（5）内的介入导管（1）、可介入至动脉血管内的压力传感器（2），以及数据处理模块，介入导管（1）上设有可朝向肾动脉血管（5）内壁释放电信号的电极元件（12），数据处理模块与压力传感器（2）相连接。通过电极元件（12）朝向肾动脉血管（5）内壁释放电信号，然后再在另一侧肾动脉血管内通过压力传感器（2）监测血压变化，由数据处理模块对压力传感器（2）监测数据进行处理并判断血压变化，通过检测人体的血压等信号来判断神经的活跃度，从而筛选出交感神经过度活跃的病人，也可以在手术前或手术后对去神经术的手术效果进行评估，并决定是否需要再次进行超声消融。

Description

电极导管系统 技术领域
本发明涉及介入治疗的技术领域，具体涉及一种电极导管系统。
背景技术
高血压病的高发病率和流行率已经成为危害人类健康的主要问题之一，是全球人类最常见的慢性病。目前有关顽固性高血压的患病率尚无精确统计，但多项临床研究提示该类患者占高血压患者的20～30％，属于常见慢性病。交感神经过度兴奋一直被认为是高血压发病的基础环节。大量的动物实验已经证实了交感神经系统对血压的影响。临床研究也发现交感神经的兴奋程度与患者的血压水平呈正相关。其中，肾脏交感神经系统,特别最靠近肾动脉壁的肾交感传出和传入神经对于诱发和保持系统性高血压起着决定性作用。
经过多次临床研究表明：经皮导管肾脏交感神经射频消融术操作简单，并发症少，能使顽固性高血压患者血压显著而持续降低，是一种新颖、简单、有效的治疗顽固性高血压的方法。虽然基于射频消融导管治疗顽固性高血压提供了很好的思路，且治疗的安全性和有效性也已得到初步验证，但是需要对病人的神经活跃度进行筛选，若高血压发病的神经活跃度不够，则不可以采用该手术进行治疗，且现有技术中进行了手术后，超声消融导管系统难以对术前和术后对去神经术的手术效果进行评估，难以根据病人 情况判断是否需要再次进行消融。
发明内容
本发明的目的在于提供一种电极导管系统，以解决现有技术中难以对术前和术后的手术效果进行评估的技术问题。
为实现上述目的，本发明采用的技术方案是：提供一种电极导管系统，包括可介入至一侧肾动脉血管内的介入导管、可介入至动脉血管内的压力传感器；以及数据处理模块，所述介入导管上设有可朝向所述肾动脉血管内壁释放电信号的电极元件；所述压力传感器与所述数据处理模块相连接。
进一步地，还包括用于监测心跳的心电检测模块，所述心电监测模块与所述数据处理模块相连接。
进一步地，所述压力传感器置于另一侧肾动脉血管内。
进一步地，所述电极元件采用弹性金属材料，且所述电极元件具有收纳于所述介入导管内的第一状态，及与所述肾动脉血管的内壁相贴合的第二状态。
进一步地，所述介入导管内设有控制丝以及容纳所述控制丝的第一导丝腔，所述电极元件与所述控制丝连接，所述控制丝在在外力的作用下在所述第一导丝腔内滑动。
进一步地，所述电极元件预成型为弧形，且所述电极元件的两端均与所述控制丝固定连接。
进一步地，所述电极元件预成型为螺旋环形，且所述电极元件的一端与控制丝固定连接。
进一步地，所述介入导管上还设有消融元件，所述消融元件位于所述介入导管的远端，所述电极元件位于所述消融元件的近端。
进一步地，所述消融元件包括球囊和设于所述球囊内的超声换能器，所述球囊固定于所述介入导管的远端。
进一步地，所述介入导管内设有第二导丝腔和导线，所述第二导丝腔位于所述球囊内的外缘设有换能器放置台，所述超声换能器固定于所述换能器放置台上，所述超声换能器与所述导线相连接。
进一步地，所述介入导管内还设有入水腔和出水腔，所述入水腔和所述出水腔均与所述球囊相连通。
进一步地，所述介入导管的近端还设有手柄，所述手柄上设有控制所述电极元件的控制钮。
本发明提供的电极导管系统的有益效果在于：
1、通过在肾动脉血管内置入电极元件，电极元件朝向肾动脉血管内壁释放电信号，然后再在除了该侧肾动脉血管外的其他动脉血管内置入压力传感器，并通过压力传感器监测血压变化，由数据处理模块对压力传感器监测数据进行处理并判断血压变化，通过检测人体的血压信号来判断神经的活跃度，从而筛选出交感神经过度活跃的病人，也可以在手术前或手术后对去神经术的手术效果进行评估，并决定是否需要再次进行超声消融。
2、通过心电监测模块对人体的心率进行监测，通过人体在电极元件通电后的心率变化结合血压变化，共同对神经的活跃度进行判断，其监测准确率更高。
3、电极元件采用弹性材质制成，可以在人体外部控制控制元件的收缩 或张开，在常态下收纳于介入导管的内部的，置于人体内部后，能够弹性的贴合在血管的内部适应血管的大小，其控制方式简单，且可以由介入导管带入至体内，对人体造成的损伤较小。
4、在介入导管的前端设置消融元件，能够将消融和检测相结合，仅需要介入一个介入导管既可以实现术前筛选、超声消融和术后检测，并且术后检测去神经术不成功还可以持续进行超声消融，使用方便且对人体可能造成的损伤较小。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明实施例1提供的电极导管系统的结构示意图，其中电极元件延伸出介入导管；
图2为本发明实施例1提供的电极导管系统的结构示意图，其中电极元件收纳于介入导管；
图3为本发明实施例1所采用的介入导管的结构示意图；
图4为图3中的A部分的局部放大剖视图；
图5为沿图3中B-B向的剖视结构图；
图6为本发明实施例2所采用的介入导管的结构示意图。
附图标记说明：
1、介入导管；2、压力传感器；3、心电监护器；4、手柄；5、肾动脉血管；11、消融元件；12、电极元件；13、第一导丝腔；14、第二导丝腔；15、入水腔；16、出水腔；121、控制丝；111、球囊；112、超声换能器；41、控制钮。
具体实施方式
下面将结合附图对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本 发明中的具体含义。
在本申请文件中，“近端”和“远端”是从使用该医疗器械的医生角度来看相对于彼此的元件或动作的相对方位、相对位置和相对方向，尽管“近端”和“远端”并非是限制性的，但是“近端”通常是指该医疗设备在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。
此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
实施例1
请一并参阅图1及图2，现对本发明提供的电极导管系统进行说明。所述电极导管系统，包括介入导管1、压力传感器2和数据处理模块(图未示)，介入导管1可以插入至一侧肾动脉血管5内，介入导管1的远端设置有消融元件11，消融元件11的近端一侧设置有电极元件12，电极元件12可以朝向肾动脉血管5的内壁释放电信号，位于其他动脉血管5内的压力传感器2可以实时的检测血管内的压力，即为检测血压，并通过数据处理模块将检测到的血管内的压力转化为血压，从而可以通过血压对神经的活跃度进行判断。
其中，数据处理模块可以为现有技术中常规的血压仪器的数据处理器，其可以将置于血管内部的压力传感器2的数值转化为人体的血压值，数据处理模块可以直接对血压是否超过某一阈值进行判断，从而得出神经的活跃度是否过高的结论，也可以直接将血压变化值反馈于一屏幕上，操作者结合血压变化规律综合得出神经的活跃度是否过高的结论，此处不作唯一 限定。
优选的，压力传感器2置于除了置有介入导管的肾动脉血管5外的其他任意血管内，从而避免电极元件12的电极信号对测量产生干扰。最优的，所述压力传感器2于另一侧肾动脉血管内，在进行手术时，能够方便操作，且测量结果更准确。
进一步的，为了进一步的加强神经活跃度检测的准确度，还可以增设心电监测模块3，结合心电监测模块3监测到的心率变化对神经的活跃度进行判断。其中，心电监测模块3可以为现有技术中常规采用的心电监测模块3，心电监测模块3与数据处理模块通信连接，通过数据处理模块可以接收心电监测模块3检测到的心率，数据处理模块可以直接对心率是否超过某一阈值进行判断，从而得出神经的活跃度是否过高的结论，也可以直接将心率变化值反馈于一屏幕上，操作者结合心率和血压的变化规律综合得出神经的活跃度是否过高的结论，此处不作唯一限定。
对于神经活跃度的具体判断标准为现有技术，通过检测人体的血压信号来判断神经的活跃度，还可以结合心率等信息进行辅助判断，从而筛选出交感神经过度活跃的病人，也可以在手术前或手术后对去神经术的手术效果进行评估，并决定是否需要再次进行超声消融。
对于神经标测在术前检测的操作步骤如下：
S1.由电极元件12朝向一侧的肾动脉血管5释放电信号；
S2.通过心电监护器3监测心率，并由压力传感器2监测另一侧肾动脉血管5内的血压变化，通过判断心率和血压变化是否到达阈值对患者的神经活跃度进行判断；
若该患者的心率和血压变化低于阈值，则该患者的神经活跃度不足，则排除由于交感神经过度兴奋导致的高血压，需要采取其他方式进行治疗；
若该患者的心率和血压变化到达阈值，则该患者的神经活跃度较强，则可能是由于交感神经过度兴奋导致的高血压，需要采取超声消融的方式对该患者进行治疗。
对于神经标测在术后检测患者的恢复情况的操作步骤如下：
S1.由电极元件12朝向一侧的肾动脉血管5释放电信号；
S2.通过心电监护器3监测心率，并由压力传感器2监测另一侧肾动脉血管5内的血压变化，通过判断心率和血压变化是否到达阈值对患者的神经活跃度进行判断；
若该患者的心率和血压变化低于阈值，则该患者的神经活跃度已经降低至标准值，证明手术完成效果较好，则可以结束治疗；
若该患者的心率和血压变化仍然到达阈值，则该患者的神经活跃度仍然较强，则判断去神经术的手术未完全达到效果，或者需要调整超声消融的部位，重复进行超声消融步骤，直至该患者的心率和血压变化低于阈值。
通过上述方法既可以在手术前或手术后对去神经术的手术效果进行评估，并决定是否需要再次进行超声消融。其中，压力传感器2可以采用现有技术中可以置于人体血管内测量血管内压力的压力传感器2，心电监护器3也可以为现有技术中常规的心电监护设备。其中，压力传感器2与心电监护器3可以共同与一控制器相连接，通过控制器对检测到的结果进行统一处理和分析，也可以分别的显示出检测的数值，并由操作者根据检测的数值进行判断，此处不作唯一限定。
进一步地，请一并参阅图3至图5，作为本发明提供的电极导管系统的一种具体实施方式，所述电极元件12采用弹性金属材料，所述电极元件12可以在控制丝121的带动下收纳于所述介入导管1内，或者在控制丝121的带动下与所述肾动脉血管5的内壁相贴合。其中控制丝121设置在介入导管1的内部，且介入导管1为多腔导管，介入导管1内部设置有用于容纳所述控制丝121的第一导丝腔13，控制丝121可以在第一导丝腔13内滑动。当然，根据实际情况和具体需求，在本发明的其他实施例中，电极元件12可以采用其他具有弹性的可以导电的材料，例如导电泡棉等，此处不作唯一限定。
其中，手柄4位于介入导管1的近端，能够方便操作者拿持，并对介入导管1进行控制。手柄4上设置有控制钮41，控制钮41可以对控制丝121的伸缩进行控制，控制丝121的一端经第一导丝腔13进入至肾动脉血管5内，另一端可以经介入导管1连接至外部的手柄4，从而在外部既可以对控制丝121进行控制，继而控制电极元件12的收放。其中，控制钮41不仅可以控制控制丝121沿着介入导管1的长度方向移动，还可以控制控制丝121沿着介入导管1的周向转动。
为了方便操作者的使用方便，手柄4上还可以设置有其他的控制按钮(图未示)，例如控制电极元件12或消融元件11的通断电的控制按钮，该控制按钮可以与导线相连接，并控制导线的通断电。
作为本发明提供的电极导管系统的一种具体实施方式，对于电极元件12一般直接采用电极丝，且电极丝预成型为弧形或圆环形，电极丝的两端为自由端，电极丝的两端均与控制丝121直接固定连接或者一体成型，电 极丝可以在控制丝121的带动下沿着介入导管1的长度方向移动，使得电极丝可以在介入导管1内移动，在未进入至预定位置前将电极元件12压缩并收纳于介入导管1的内部，避免造成额外的损伤；在进入至预定位置后控制丝121带动电极元件12朝向远端移动，此时电极元件12则可以张开并逐渐与血管内壁相抵接；在操作完成后，控制丝121带动电极元件12朝向近端移动，此时电极元件12可以重新收缩收纳于介入导管1内部。当然，根据实际情况和具体需求，在本实用新型的其他实施例中，电极元件12还可以预成型为方形或三角形等，此处不作唯一限定。
进一步地，请参阅图4，作为本发明提供的电极导管系统的一种具体实施方式，所述介入导管1上还设有消融元件11，消融元件11是指可以在消融手术中进行超声消融的元件，所述消融元件11位于所述介入导管1的远端，所述电极元件12位于所述消融元件11的一侧的近端，电极元件12和消融元件11均位于肾动脉血管5的内部。
其中，消融元件11包括球囊111和设于所述球囊111内的超声换能器112，所述球囊111套设于介入导管1上，且固定于所述介入导管1的远端，球囊111可以在注入液体或气体后膨胀，并包覆于超声换能器112的外部，并对超声换能器112进行保护，避免超声换能器112直接与人体接触。超声换能器112可以采用现有技术中的常规的能够实现超声消融的超声换能器112，超声换能器112可以根据需要设置一个或多个。
介入导管1为多腔导管，介入导管1的内部具有多个腔室，其内部具有第一导丝腔13、第二导丝腔14、入水腔15和出水腔16，其中第一导丝腔13用于供控制丝121穿过，其长度为由手柄4延伸至控制丝121；第二 导丝腔14用于供其他操作导引导丝穿过，其一般贯通整个介入导管1，入水腔15和出水腔16均与所述球囊111相连通，入水腔15和出水腔16内可以供冷水通过，入水腔15的近端端部与加压注射器连接，加压注射器装有冷水。入水腔15的远端端部均与球囊111相连通，且在远端部分的侧壁开设多个出水口，出水口与球囊111连通，当需要进行超声消融时球囊111内部充满冷水，同时冷水可以从出水腔16流出至人体外部，使得球囊111内的冷水可以实现循环，且在完成超声消融时，冷水可以全部从出水腔16排出，能够有效地避免超声换能器112在使用时温度过高。
其中，介入导管1内还设置有导线(图未示)，导线可以为超声换能器112和电极元件12提供电能，导线可以直接位于介入导管1的内部，也可以收容于第二导丝腔14或其他腔室内部。
优选的，为了方便导线为超声换能器112提供电能，球囊111的内部远端仅具有第二导丝腔14，在第二导丝腔14的外缘直接设置供超声换能器112固定的换能器放置台(图未示)，导线可以穿设于第二导丝腔14的内部并经过换能器放置台与超声换能器112相连接。其中，换能器放置台也可以采用现有技术中常规的换能器放置台。
在使用时，将介入导管1置入患者的肾动脉血管5内，并同时监测另一侧肾动脉血管5内的血压变化和监测心率，介入导管1置于肾动脉血管5内的特定位置后，控制按钮控制控制丝121沿着介入导管1的长度方向运动，控制丝121带动电极元件12朝向远端运动，电极元件12在弹性的作用下释放扩大，直至电极元件12贴靠在肾动脉血管5的内壁上；控制电极元件12释放电信号，若满足超声消融的条件，则通过入水口朝向球囊111 内注水并通过出水口回水实现水循环，超声换能器112开始进行超声消融工作。
若检测该患者的神经活跃度已经降低至标准值时，则完成超声消融工作，停止超声换能器112并停止朝向球囊111内注水，球囊111内的水从出水口流出；控制丝121带动电极元件12朝向近端运动，电极元件12在介入导管1内壁的作用下压缩，并利用其弹性能贴靠在介入导管1的内壁上。
实施例2
参阅图6，作为本发明提供的电极导管系统的另一种具体实施方式，本实施例与实施例1的区别在于：所述电极元件12预成型为螺旋环形，且所述电极元件12的一端与控制丝121固定连接。电极元件12仍为电极丝，其预成型为螺旋的环形，该电极丝也具有两个自由端，其中一个自由端直接与控制丝121固定连接或一体成型，另一个自由端位于控制丝121的远端。控制丝121可以在第一导丝腔13的内部沿着介入导管1的长度方向移动，并且可以环绕介入导管1的周向转动，从而逐渐将电极丝释放纸介入导管1的外部并与肾动脉血管1的内壁相抵接，此时电极丝与肾动脉血管1的内壁的抵接面和抵接范围更大，电极元件12在朝向肾动脉血管5释放电信号时，刺激位置更广。当然，根据实际情况和具体需求，在本实用新型的其他实施例中，电极元件12的形状还可以为螺旋的椭圆形、螺旋的三角形等，此处不作唯一限定。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方 式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。

Claims (12)

  1. 电极导管系统，其特征在于，包括：
    介入导管(1)，所述介入导管(1)上设有可朝向肾动脉血管(5)内壁释放电信号的电极元件(12)；
    可介入至动脉血管内的压力传感器(2)；以及
    数据处理模块，所述压力传感器(2)与所述数据处理模块相连接。
  2. 如权利要求1所述的电极导管系统，其特征在于：还包括用于监测心跳的心电监测模块(3)，所述心电监测模块(3)与所述数据处理模块相连接。
  3. 如权利要求1所述的电极导管系统，其特征在于：所述压力传感器(2)置于另一侧肾动脉血管内。
  4. 如权利要求1所述的电极导管系统，其特征在于：所述电极元件(12)采用弹性金属材料，且所述电极元件(12)具有收纳于所述介入导管(1)内的第一状态，及与所述肾动脉血管(5)的内壁相贴合的第二状态。
  5. 如权利要求4所述的电极导管系统，其特征在于：所述介入导管(1)内设有控制丝(121)以及容纳所述控制丝(121)的第一导丝腔(13)，所述电极元件(12)与所述控制丝(121)连接，所述控制丝(121)在外力的作用下在所述第一导丝腔(13)内滑动。
  6. 如权利要求5所述的电极导管系统，其特征在于：所述电极元件(12)预成型为弧形，且所述电极元件(12)的两端均与所述控制丝(121)固定连接。
  7. 如权利要求5所述的电极导管系统，其特征在于：所述电极元件(12) 预成型为螺旋环形，且所述电极元件(12)的一端与控制丝(121)固定连接。
  8. 如权利要求1至7任一项所述的电极导管系统，其特征在于：所述介入导管(1)上还设有消融元件(11)，所述消融元件(11)位于所述介入导管(1)的远端，所述电极元件(12)位于所述消融元件(11)的近端。
  9. 如权利要求8所述的电极导管系统，其特征在于：所述消融元件(11)包括球囊(111)和设于所述球囊(111)内的超声换能器(112)，所述球囊(111)固定于所述介入导管(1)的远端。
  10. 如权利要求9所述的电极导管系统，其特征在于：所述介入导管(1)内设有第二导丝腔(14)和导线，所述第二导丝腔(14)位于所述球囊(111)内的外缘设有换能器放置台，所述超声换能器(112)固定于所述换能器放置台上，所述超声换能器(112)与所述导线相连接。
  11. 如权利要求9所述的电极导管系统，其特征在于：所述介入导管(1)内还设有入水腔(15)和出水腔(16)，所述入水腔(15)和所述出水腔(16)均与所述球囊(111)相连通。
  12. 如权利要求1至7任一项所述的电极导管系统，其特征在于：所述介入导管(1)的近端还设有手柄(4)，所述手柄(4)上设有控制所述电极元件(12)的控制钮(41)。
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