WO2014012282A1 - Controllable renal artery radio-frequency ablation electrode catheter - Google Patents

Controllable renal artery radio-frequency ablation electrode catheter Download PDF

Info

Publication number
WO2014012282A1
WO2014012282A1 PCT/CN2012/079947 CN2012079947W WO2014012282A1 WO 2014012282 A1 WO2014012282 A1 WO 2014012282A1 CN 2012079947 W CN2012079947 W CN 2012079947W WO 2014012282 A1 WO2014012282 A1 WO 2014012282A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
ablation
renal artery
catheter
monitoring
Prior art date
Application number
PCT/CN2012/079947
Other languages
French (fr)
Chinese (zh)
Inventor
吴书林
程晓曙
成正辉
韩永贵
郭怀球
Original Assignee
深圳市惠泰医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 深圳市惠泰医疗器械有限公司 filed Critical 深圳市惠泰医疗器械有限公司
Publication of WO2014012282A1 publication Critical patent/WO2014012282A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505Urinary tract
    • A61B2018/00511Kidney
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00839Bioelectrical parameters, e.g. ECG, EEG
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002Irrigation

Definitions

  • the present invention relates to an interventional medical device, and more particularly to a radiofrequency ablation electrode catheter for transdermal, vascular, and renal artery access to treat refractory hypertension.
  • Comparison of blood pressure patients demonstrates the safety and efficacy of percutaneous catheter ablation for the treatment of refractory hypertension, a method that demonstrates a significant advance in the conversion of physiology into specific therapeutic goals.
  • Esler It was reported that compared with the control group, the blood pressure of the patients in the test group had a significant decrease at 1 month, 3 months, and 6 months. Small sample test results indicate that it is effective for at least two years. The report also showed that the blood vessels were safe after radiofrequency ablation. Eighteen patients were evaluated for angiography within 14 to 30 days after radiofrequency ablation. No damage or abnormalities were found at the radiofrequency ablation site of the renal artery.
  • Renal sympathetic radiofrequency ablation is a spiral of ablation in the renal artery. On the one hand, it effectively blocks all sympathetic nerves, on the other hand, it reduces renal artery intimal damage and avoids renal artery stenosis.
  • no clear surgical end point has been established for renal artery ablation at home and abroad. Take the Medtronic Ardian as an example. The end point of the operation is that the ablation electrode temperature is above 50 °C and the impedance is reduced by more than 10%. However, this endpoint does not indicate that adequate ablation has been performed and that the termination of surgery is quite blind.
  • Another method of the prior art is to ablate arrhythmia ablation catheter to ablate the sympathetic nerves on the renal artery for the purpose of treating refractory hypertension.
  • the ablation catheter has a large diameter and is inconvenient to manipulate in the renal artery. And the ablation area is large, causing greater damage to the renal artery.
  • the object of the present invention is to provide a renal artery radiofrequency ablation controllable electrode catheter, and the technical problem to be solved is to effectively remove the sympathetic nerves on the renal artery wall and reduce the damage to the inner wall of the blood vessel.
  • the renal artery radiofrequency ablation controllable electrode catheter of the present invention is provided with a catheter tube body, the distal end of the catheter tube body is connected with an electrode, and the proximal end is connected with a manipulation handle, and the electrode is an ablation electrode and a monitoring electrode.
  • the ablation electrode and the monitoring electrode of the present invention are disposed at the distal end along the axis of the catheter tube body, and a gap is provided between the ablation electrode and the monitoring electrode.
  • the ablation electrode of the invention adopts a platinum-iridium alloy hollow rod or tube, the distal end portion has a circular arc shape, and the ablation electrode is provided with a cold saline perfusion hole.
  • the ablation electrode of the present invention has an outer diameter of 1 mm to 2.67 mm, a length of 1 mm to 4 mm, a cold saline perfusion hole of 1 to 20, a pore diameter of 0.1 mm to 0.4 mm, and is distributed on the distal end portion of the ablation electrode and the tube wall.
  • the monitoring electrode of the present invention is annular, having an outer diameter of 1 mm to 2.67 mm and a length of 0.4 mm to 1 mm.
  • the monitoring electrode of the present invention is provided with a temperature measuring element.
  • the temperature measuring element of the present invention is disposed in a groove in the axial direction inside the monitoring electrode ring.
  • the interval between the ablation electrode and the monitoring electrode of the present invention is 0.2 mm to 2 mm.
  • the ablation electrode of the invention has an outer diameter of 1.25 mm and a length of 1.6 mm, and has 9 cold saline perfusion holes on the ablation electrode, wherein three cold brine perfusion holes are evenly distributed at the end of the electrode, and six cold saline perfusion holes are uniformly distributed in the ablation.
  • the tube is in the middle of the tube wall;
  • the monitoring electrode has an outer diameter of 1.33 mm and a length of 0.6 mm;
  • the temperature measuring element is a thermocouple; and the interval is 0.5 mm.
  • the control handle of the present invention adjusts the distal end of the catheter catheter body to be bent or straightened at a distance of 6 mm to 75 mm and rotated to a position of 120° or 60°, 72°, 180° or 90°.
  • the electrode is provided with an ablation electrode and a monitoring electrode, the perfusion electrode has no perfusion hole, the monitoring electrode is annular, and the adjacent ablation electrode is separated, and the distance ablation electrode is monitored at a distance of 0.5-2.5 mm.
  • the temperature of the nerve tissue thereby monitoring the temperature of the ablation zone, each of which is equipped with a thermocouple or a thermistor, and monitors the temperature of the ablated sympathetic tissue during ablation to determine the clinical treatment requirements.
  • FIG. 1 is a schematic view showing the structure of a renal artery radiofrequency ablation controllable electrode catheter of the present invention.
  • Figure 2 is an axial cross-sectional view of the ablation electrode of the present invention.
  • Figure 3-1 is a schematic view showing the assembly of the ablation electrode and the saline tube, the wire and the thermocouple of the present invention.
  • Figure 3-2 is a left side view of Figure 3-1.
  • FIG. 4 is a schematic view showing the assembly of the ablation electrode and the monitor electrode of the present invention.
  • Figure 5 is a schematic illustration of an ablation zone of the present invention.
  • Figure 6 is a schematic view showing the structure of a catheter tube body of the present invention.
  • Figure 7-1 is a schematic view of the structure of the handle of the present invention.
  • Figure 7-2 is a right side view of the handle of the present invention.
  • Figure 7-3 is a left side view of the handle of the present invention.
  • Figure 7-4 is a schematic view of the handle of the handle of the present invention.
  • Figure 8 is a schematic illustration of a surgical example ablation line of the present invention.
  • the renal artery radiofrequency ablation controllable electrode catheter of the embodiment of the present invention is sequentially connected from the distal end to the proximal end by the ablation electrode 1, the monitoring electrode 2, the catheter tube body 3, and the manipulation handle 4.
  • a proximal end of the control handle 4 is extended with a wire extension line 7.
  • the proximal end of the wire extension wire 7 is electrically connected to the connector 8.
  • the proximal end of the control handle 4 is connected with a cold brine connection pipe 9, and the cold brine connection pipe 9 is connected to the proximal end connector 10. .
  • the proximal end of the manipulation handle 4 is a handle 5, and a middle portion of the handle 5 is provided with a hand lever 6 for adjusting the angle of bending and rotation of the distal end of the catheter tube 3.
  • a white depth marking scale 11 is provided on the proximal edge of the catheter tube 3 for observing the depth of control of the renal artery radiofrequency ablation of the controllable electrode into the radiofrequency ablation site.
  • the proximal end of the catheter tube 3 is coupled to the steering handle 4 to control the deflection of the distal portion of the catheter tube 3.
  • the inside of the catheter tube 3 has a passage through the ablation electrode for saline infusion, and the saline enters the catheter tube 3 from the proximal joint 10, and flows out from the cold saline perfusion hole 14 on the ablation electrode 1, and the ablation electrode 1 is fully performed. Cooling, increasing ablation power, effectively removing sympathetic nerves. It can also be used without perfusion of saline to interrupt the superficial ECG and transmit neurons.
  • the ablation electrode 1 adopts a platinum-iridium alloy hollow rod or tube 12, and the ablation electrode 1 has an outer diameter of 1 mm to 2.67 mm and a length of 1 mm to 4 mm.
  • the outer diameter of the embodiment is 1.25 mm and the length is 1.6 mm, and the distal end portion is Arc shape 13.
  • the ablation electrode 1 has 1-20 cold brine perfusion holes 14 with a pore diameter of 0.1 mm-0.4 mm.
  • nine are processed by a precision laser produced by Shenzhen Dazu Laser Co., Ltd., wherein three cold brine perfusion holes are uniformly distributed at the distal end of the ablation electrode 1, and six cold saline perfusion holes are evenly distributed in the middle of the ablation electrode. On the wall of the tube, the center of the hole is 1 mm from the distal end.
  • the proximal end of the ablation electrode 1 is provided with an annular monitoring electrode 2, and the monitoring electrode 2 is electrically connected to the temperature measuring element line 15.
  • the monitoring electrode 2 is provided with a temperature measuring element 16 which is disposed in the groove 17 in the axial direction of the monitoring electrode 2.
  • the monitoring electrode 2 has an outer diameter of 1 mm to 2.67 mm and a length of 0.4 mm to 1 mm for measuring temperature and measuring conduction sympathetic potential.
  • the outer diameter of the embodiment is 1.33 mm and the length is 0.6 mm
  • the temperature measuring element is a thermocouple.
  • a wire 18 for transmitting radio frequency energy is connected to the ablation electrode 1, and the distal end of the wire 18 is electrically connected to the ablation electrode 1.
  • the cold saline is connected to the distal end of the tube 9 to the ablation electrode 1.
  • the interval 19 between the monitoring electrode 2 and the ablation electrode 1 in the axial direction is 0.2 mm - 2 mm, which is 0.5 mm in this embodiment.
  • Radiofrequency ablation is achieved by an increase in the temperature of the sympathetic nerve tissue on the wall of the renal artery.
  • the temperature reaches 50 ° C, the nerve cells will be necrotic, so the temperature of the sympathetic nerve tissue reaches 50 ° C or above, which is a sign of effective ablation.
  • the temperature is radiated outwardly around the ablation electrode 1.
  • the ablation region is also radially expanded outward from the ablation electrode 1, and the tissue region having a temperature of 50 ° C or higher is For effective ablation zone. It is therefore possible to determine the size of the true ablation zone by monitoring the temperature of the tissue surrounding the ablation electrode 1 to determine whether to abort the radiofrequency ablation.
  • an annular monitoring electrode 2 having a length of 0.6 mm along the axis is provided at a proximal end position of 0.5 mm from the ablation electrode, and a thermocouple is mounted therein for monitoring the temperature of the sympathetic nerve tissue around the ablation electrode 1.
  • a thermocouple is mounted therein for monitoring the temperature of the sympathetic nerve tissue around the ablation electrode 1.
  • the catheter tube body 3 is 750 mm to 1500 mm long, and has an outer diameter of 1.33 mm to 2.67 mm and an inner diameter of 0.50 mm to 1.50 mm.
  • the catheter tube body of this embodiment has a length of 850 mm, an outer diameter of 1.67 mm, and an inner diameter of 1.50 mm.
  • the catheter tube body 3 is composed of a biocompatible polymer material, and the hardness of the catheter tube body from the proximal end to the distal end is gradually changed from soft to soft, and the prior art is the same as the prior art intervening tube material. The difference is that the proximal end of the catheter tube 3 of the present embodiment uses a stainless steel tube 20 to ensure that the torsional performance of the catheter is close to 1:1.
  • the middle portion of the duct body 3 is a composite tube of a Teflon tube 21 and a stainless steel mesh 22 to ensure flexibility of the catheter, and the distal end of the catheter tube 3 is made of a nylon elastomer 23.
  • the catheter proximal stainless steel tube 20 has a white depth marking scale 11 for precise control of the depth of the renal artery radiofrequency ablation controllable electrode into the radiofrequency ablation site.
  • the manipulation handle 4 is composed of a distal rotation knob 51 and a proximal handle 5 connected.
  • the rotating handle 51 is used for connecting the catheter tube body 3.
  • the rotating handle 51 is provided with a hand wrench 6 for rotating the catheter to an appropriate angle, and the front and rear lever 6 can adjust the bending of the distal end of the catheter tube body 6 mm-75 mm or Straighten out.
  • the handle 5 is used to fix the position after the rotation of the catheter.
  • the manipulation handle 4 can be rotated to three positions: 120° or 60°, 72°, 180° or 90°, respectively for 3 points in the circumferential direction or 6, 5, 2 or 4 RF ablation.
  • the handle 4 is bent or straightened, and the rotation can be made using the prior art structure.
  • the renal artery radiofrequency ablation instrument used is a dedicated ablation device connected to the renal artery radiofrequency ablation controllable electrode catheter of the present invention through a dedicated extension cable.
  • the technical specifications of the renal artery radiofrequency ablation device are as follows:
  • the default value of the renal artery radiofrequency ablation device is 8W, the adjustment accuracy is ⁇ 0.2W; the temperature default is 41°C. The adjustment accuracy is ⁇ 1 °C; the impedance cutoff limit is 400 ohms by default; the default value of the ablation time is 60 seconds, adjustable from 1-150 seconds.
  • the renal artery radiofrequency ablation device can display changes in impedance and record impedance reduction ratios.
  • the brine perfusion pump flow rate adjustment range is 5-50ml/min, the default value is 10ml/min, the low flow rate adjustment range is 1-5ml/min, and the default value is 2ml/min.
  • the surgical object select castrated adult boar, weight 45kg -60 kg, the smallest size of the renal artery is 3.5 mm in diameter and 15 mm in length. This surgery example selects 45 kg castrated adult boars.
  • the pigtail catheter Under X-ray, the pigtail catheter is delivered along the guidewire to the descending aorta near the renal artery. Inject nitroglycerin before angiography. The diameter and length of the renal artery are quantitatively assessed based on the injected contrast agent to determine the appropriate radiofrequency ablation point. The pigtail catheter is withdrawn, the guiding catheter is fed along the guide wire and the guiding catheter is delivered into the renal artery, and the guide wire is withdrawn.
  • the diameter of the renal artery is 3.5mm-4.5mm, and the curved catheter bent at the distal end of the catheter 6mm is selected;
  • the diameter of the renal artery is 4.5mm-6mm, and the curved catheter bent at the distal end of the catheter is selected at 9mm;
  • the diameter of the renal artery is greater than 6 mm, and a curved catheter bent at 12 mm distal to the catheter is selected.
  • the length of the renal artery is 15mm-19mm or more than 30mm, 120° or 60° is selected, and the handle handle is ablated at 3 or 6 o'clock;
  • the length of the renal artery is 25mm-29mm, 72° is selected, and the handle is ablated at 5 o'clock;
  • the length of the renal artery is 10mm-14mm or 20mm-24mm. Choose 180° or 90°, and the handle will be ablated at 2 or 4 o'clock.
  • the renal artery radiofrequency ablation controllable electrode catheter was connected with the renal artery radiofrequency ablation instrument and the saline perfusion pump, and the saline perfusion pump was started to perfuse at a high speed of 10 ml/min until the air in the catheter was completely discharged, and then the saline perfusion pump was adjusted to 2 ml. Low-speed perfusion of /min.
  • the site that meets the ablation conditions at the end, the site that meets the ablation conditions is the vessel diameter ⁇ 3.5 mm.
  • the femoral artery puncture is sutured and the surgical incision is also sutured.
  • Animals were euthanized by injection of a dose of ampoules or potassium chloride IV solution into the subject (boar).
  • the renal artery of the experimental animal was collected, and the renal artery was dissected along the length of the renal artery. The lesion was spiraled.
  • the cross section of the renal artery was cut into several pieces, which were in the kidney. A complete cylindrical burn with a circumference of 12 mm to 24 mm was seen on the inner wall of the artery.
  • the electrodes of the present invention are arranged in groups, each group comprising an ablation electrode and a monitoring electrode, and the distal end of the catheter tube body may be provided with more than one set of electrodes along the axis.
  • This embodiment is a group, an ablation electrode and a monitoring lead. There is no perfusion hole on the ablation electrode, and the monitoring electrode is annular. The temperature of the sympathetic nerve tissue at 0.5-2.5 mm from the ablation electrode is monitored by the interval ablation electrode to monitor the temperature of the ablation zone.
  • Each monitoring electrode is equipped with a temperature measuring element thermocouple or thermistor, and the temperature of the ablated sympathetic nerve tissue is monitored during the ablation process to determine the clinical treatment requirement value, and the ablation end point is determined to ensure effective ablation, and Reduces damage to the inner wall of blood vessels and protects blood vessels.
  • a catheter that overcomes the prior art can only measure the temperature of the ablation electrode, which is the temperature at the center of the ablation zone, rather than the temperature of the tissue at the edge of the ablation zone, and cannot detect the size of the ablation zone.
  • the monitoring electrode can also be connected with the electrophysiological instrument to monitor the conduction of the sympathetic nerve signal, compare the sympathetic nerve conduction waveform before and after the ablation, and assist in judging whether the surgical end point is completed.
  • the invention solves the problem that the prior art catheter has no end point in clinical operation.
  • radiofrequency ablation which is widely used in clinical arrhythmia
  • the structure of the present invention can also be used for cardiac radiofrequency ablation, monitoring the tissue temperature of the ablation zone. It completely interrupts the abnormal conduction of ECG, ensures effective ablation, and greatly reduces the recurrence rate.

Abstract

A radio-frequency ablation electrode catheter used for treating refractory hypertension by entering a renal artery through skin and a vessel. The electrode catheter is provided with a catheter body (3). The distal end of the catheter body (3) is connected to an electrode, and the proximal end thereof is connected to a manipulation handle (4); an ablation electrode (1) and a monitoring electrode (2) are arranged on the distal end along the axis of the catheter body (3); a distance is provided between the ablation electrode (1) and the monitoring electrode (2); the ablation electrode (1) is provided thereon with a pour hole (14); and the monitoring electrode (2) monitors the temperature of the ablated sympathetic nerve tissue during an ablation process, judges whether a required value for clinical treatment has been reached, and can also obtain the conduction of a sympathetic nerve signal, and assist in judging whether the end of the operation has been reached by comparing the conduction waveforms of the sympathetic nerve before and after the ablation.

Description

肾动脉射频消融可控电极导管  Renal artery radiofrequency ablation controllable lead 肾动脉射频消融可控电极导管  Renal artery radiofrequency ablation controllable lead
技术领域Technical field
本发明涉及一种介入治疗的医疗器械,特别是一种用于经皮、血管、进入肾动脉治疗顽固性高血压的射频消融电极导管。The present invention relates to an interventional medical device, and more particularly to a radiofrequency ablation electrode catheter for transdermal, vascular, and renal artery access to treat refractory hypertension.
背景技术Background technique
全世界大概有近五分之一到三分之一的成人患有高血压,高血压每年导致750万人死亡,死亡率居全球首位。成人血压每增加20/10mmHg,则心血管疾病的死亡率增加一倍。尽管医务工作者加大了努力来更好的诊断和控制高血压,也仅仅只有一半接受治疗的患者实现了既定的血压指标。传统的药物控制治疗方案,病人的依从性、医师的惰性、药物的副作用和药物的无效性都是导致控制效果差的因素,现在欧洲不允许给糖尿病或eGFR <60的患者使用ACE 或ARB联合阿利吉仑治疗,也就是药物对顽固性高血压的治疗越来越力不从心,广大医患渴望出现新的治疗方法。Nearly one-fifth to one-third of adults in the world suffer from high blood pressure, and hypertension causes 7.5 million deaths each year, with the highest mortality rate in the world. For every 20/10 mmHg increase in adult blood pressure, the mortality rate of cardiovascular disease is doubled. Although medical workers have increased their efforts to better diagnose and control high blood pressure, only half of the patients receiving treatment have achieved established blood pressure indicators. Traditional drug-controlled treatment regimens, patient compliance, physician inertia, drug side effects, and drug ineffectiveness are all factors that contribute to poor control. Currently, diabetes or eGFR is not allowed in Europe. <60 patients treated with ACE or ARB in combination with aliskiren, that is, drugs are becoming more and more inadequate for the treatment of refractory hypertension, and the majority of doctors are eager to develop new treatments.
顽固性高血压在临床上较常见,致病因素众多,发病机制不明确,药物治疗效果很差。医学界一直认为,肾脏的交感神经兴奋和血压升高关系密切,肾交感神经早已被证实为高血压发生和维持的起因。近期报道的首先去肾交感神经射频消融导管系统(美敦力Ardian)进行的Symplicity HTN-2研究的结果,在该研究中,研究者利用Symplicity导管系统从肾动脉管腔内传输射频RF能量,消融动脉外膜的肾脏传入神经和传出神经,同时与只依靠药物治疗控制血压的患者进行对比,说明运用经皮导管消融术治疗顽固性高血压的安全性和有效性,这个方法表明了生理学知识转化为特定治疗目标的一个重大进步。据Esler 等报道,相比对照组,试验组患者的诊室血压在1个月、3个月、6个月有一个明显的降低。小样本试验结果表明至少在两年内是有效的。报告中也显示射频消融治疗后血管很安全,射频消融治疗后14~30天内对18例患者进行了血管造影评价,在肾动脉的射频消融点未发现损伤或异常。同样地,对Symplicity HTN-1 和Symplicity HTN-2研究中的124例患者进行6个月后影像检查未发现与射频消融相关的不良事件,而且他们当中的大部分都做了CT或MR血管造影或肾多普勒成像。射频消融治疗后无肾动脉病理学损伤,表明其与高功率射频消融心房和肺静脉治疗心律失常而引发血栓和狭窄有显著的区别。Refractory hypertension is more common in clinical practice, with many pathogenic factors, unclear pathogenesis, and poor drug treatment. The medical community has always believed that the sympathetic excitation of the kidney is closely related to the increase of blood pressure, and the renal sympathetic nerve has long been confirmed as the cause of the occurrence and maintenance of hypertension. Recently reported Symplicity to the renal sympathetic radiofrequency ablation catheter system (Medtronic Ardian) The results of the HTN-2 study, in which the researchers used the Symplicity catheter system to transmit RF RF energy from the renal artery lumen, ablate the renal afferent and efferent nerves of the adventitial membrane, and controlled with drug therapy alone. Comparison of blood pressure patients demonstrates the safety and efficacy of percutaneous catheter ablation for the treatment of refractory hypertension, a method that demonstrates a significant advance in the conversion of physiology into specific therapeutic goals. According to Esler It was reported that compared with the control group, the blood pressure of the patients in the test group had a significant decrease at 1 month, 3 months, and 6 months. Small sample test results indicate that it is effective for at least two years. The report also showed that the blood vessels were safe after radiofrequency ablation. Eighteen patients were evaluated for angiography within 14 to 30 days after radiofrequency ablation. No damage or abnormalities were found at the radiofrequency ablation site of the renal artery. Similarly, for Symplicity HTN-1 and Symplicity The 124 patients in the HTN-2 study did not find adverse events associated with radiofrequency ablation after 6 months of imaging, and most of them underwent CT or MR angiography or renal Doppler imaging. There was no renal artery pathological damage after radiofrequency ablation, indicating a significant difference between high-power radiofrequency ablation of atrial and pulmonary veins in the treatment of arrhythmias and thrombosis and stenosis.
肾交感神经射频消融(肾动脉消融)术是在肾动脉内消融一条螺旋线,一方面有效隔断全部交感神经,另一方面降低肾动脉内膜损伤,避免肾动脉狭窄。目前,国内外进行的肾动脉消融术均尚未建立明确的手术终点。以美敦力Ardian为例,其手术终点是消融电极温度达到50℃以上,阻抗降低10%以上。但此终点并不表明已进行了充分的消融,终止手术有相当大的盲目性。现有技术的另一种方法是采用治疗心律失常的消融导管来消融肾动脉上的交感神经,达到治疗顽固性高血压的目的,此种消融导管直径较粗大,在肾动脉血管内操纵不方便,而且消融面积较大,对肾动脉造成较大的损伤。 Renal sympathetic radiofrequency ablation (renal artery ablation) is a spiral of ablation in the renal artery. On the one hand, it effectively blocks all sympathetic nerves, on the other hand, it reduces renal artery intimal damage and avoids renal artery stenosis. At present, no clear surgical end point has been established for renal artery ablation at home and abroad. Take the Medtronic Ardian as an example. The end point of the operation is that the ablation electrode temperature is above 50 °C and the impedance is reduced by more than 10%. However, this endpoint does not indicate that adequate ablation has been performed and that the termination of surgery is quite blind. Another method of the prior art is to ablate arrhythmia ablation catheter to ablate the sympathetic nerves on the renal artery for the purpose of treating refractory hypertension. The ablation catheter has a large diameter and is inconvenient to manipulate in the renal artery. And the ablation area is large, causing greater damage to the renal artery.
发明内容Summary of the invention
本发明的目的是提供一种肾动脉射频消融可控电极导管,要解决的技术问题是有效去除肾动脉管壁上的交感神经,减少对血管内壁的损伤。The object of the present invention is to provide a renal artery radiofrequency ablation controllable electrode catheter, and the technical problem to be solved is to effectively remove the sympathetic nerves on the renal artery wall and reduce the damage to the inner wall of the blood vessel.
本发明的肾动脉射频消融可控电极导管,设有导管管体,导管管体的远端连接有电极,近端连接有操控手柄,所述电极为消融电极和监测电极。The renal artery radiofrequency ablation controllable electrode catheter of the present invention is provided with a catheter tube body, the distal end of the catheter tube body is connected with an electrode, and the proximal end is connected with a manipulation handle, and the electrode is an ablation electrode and a monitoring electrode.
本发明的消融电极和监测电极沿导管管体的轴线设置设置在远端,消融电极和监测电极之间设有间隔。The ablation electrode and the monitoring electrode of the present invention are disposed at the distal end along the axis of the catheter tube body, and a gap is provided between the ablation electrode and the monitoring electrode.
本发明的消融电极采用铂铱合金空心棒或管,远端端部为圆弧形状,消融电极上开有冷盐水灌注孔。The ablation electrode of the invention adopts a platinum-iridium alloy hollow rod or tube, the distal end portion has a circular arc shape, and the ablation electrode is provided with a cold saline perfusion hole.
本发明的消融电极外径1mm-2.67mm,长1mm-4mm,冷盐水灌注孔为1-20个,孔径为0.1mm-0.4mm,分布于消融电极的远端端部和管壁上。The ablation electrode of the present invention has an outer diameter of 1 mm to 2.67 mm, a length of 1 mm to 4 mm, a cold saline perfusion hole of 1 to 20, a pore diameter of 0.1 mm to 0.4 mm, and is distributed on the distal end portion of the ablation electrode and the tube wall.
本发明的监测电极为环状,外径1mm-2.67mm,长0.4mm-1mm。The monitoring electrode of the present invention is annular, having an outer diameter of 1 mm to 2.67 mm and a length of 0.4 mm to 1 mm.
本发明的监测电极内装有测温元件。The monitoring electrode of the present invention is provided with a temperature measuring element.
本发明的测温元件设置在监测电极环内沿轴向的凹槽内。The temperature measuring element of the present invention is disposed in a groove in the axial direction inside the monitoring electrode ring.
本发明消融电极和监测电极之间的间隔为0.2mm-2mm。The interval between the ablation electrode and the monitoring electrode of the present invention is 0.2 mm to 2 mm.
本发明的消融电极外径1.25mm,长1.6mm,消融电极上开有9个冷盐水灌注孔,其中3个冷盐水灌注孔均匀分布在电极端部,6个冷盐水灌注孔均匀分布在消融电极中部的管壁上;所述监测电极外径1.33mm,长0.6mm;所述测温元件是热电偶;所述间隔为0.5mm。The ablation electrode of the invention has an outer diameter of 1.25 mm and a length of 1.6 mm, and has 9 cold saline perfusion holes on the ablation electrode, wherein three cold brine perfusion holes are evenly distributed at the end of the electrode, and six cold saline perfusion holes are uniformly distributed in the ablation. The tube is in the middle of the tube wall; the monitoring electrode has an outer diameter of 1.33 mm and a length of 0.6 mm; the temperature measuring element is a thermocouple; and the interval is 0.5 mm.
本发明的操控手柄调节导管导管管体远端6mm-75mm处弯曲或伸直,旋转至120°或60°,72°,180°或90°位置。The control handle of the present invention adjusts the distal end of the catheter catheter body to be bent or straightened at a distance of 6 mm to 75 mm and rotated to a position of 120° or 60°, 72°, 180° or 90°.
本发明与现有技术相比,电极设置有一个消融电极和一个监测电极,消融电极上没有灌注孔,监测电极为环状,经间隔相邻消融电极,监测距离消融电极0.5-2.5mm处交感神经组织的温度,从而监测消融区域的温度,每个监测电极内部都装有测温元件热电偶或热敏电阻,在消融过程中监测被消融的交感神经组织的温度,以判断达到临床治疗要求值,确定消融终点,以确保有效消融,并减少对血管内壁的损伤,保护血管,还可通过监测电极获取交感神经信号的传导,对比消融前后交感神经传导波形,辅助判断手术终点是否完成。Compared with the prior art, the electrode is provided with an ablation electrode and a monitoring electrode, the perfusion electrode has no perfusion hole, the monitoring electrode is annular, and the adjacent ablation electrode is separated, and the distance ablation electrode is monitored at a distance of 0.5-2.5 mm. The temperature of the nerve tissue, thereby monitoring the temperature of the ablation zone, each of which is equipped with a thermocouple or a thermistor, and monitors the temperature of the ablated sympathetic tissue during ablation to determine the clinical treatment requirements. Value, determine the end point of ablation, to ensure effective ablation, and reduce damage to the inner wall of the blood vessel, protect the blood vessels, can also obtain the conduction of sympathetic nerve signals through the monitoring electrode, compare the sympathetic nerve conduction waveform before and after ablation, and help determine whether the surgical end point is completed.
附图说明DRAWINGS
图1是是本发明的肾动脉射频消融可控电极导管的结构示意图。1 is a schematic view showing the structure of a renal artery radiofrequency ablation controllable electrode catheter of the present invention.
图2本发明的消融电极轴向剖意图。Figure 2 is an axial cross-sectional view of the ablation electrode of the present invention.
图3-1是本发明消融电极与盐水管、导线和热电偶装配示意图。Figure 3-1 is a schematic view showing the assembly of the ablation electrode and the saline tube, the wire and the thermocouple of the present invention.
图3-2是图3-1的左视图。Figure 3-2 is a left side view of Figure 3-1.
图4是本发明的消融电极与监测电极装配示意图。4 is a schematic view showing the assembly of the ablation electrode and the monitor electrode of the present invention.
图5是本发明消融区域的示意图。Figure 5 is a schematic illustration of an ablation zone of the present invention.
图6是本发明的导管管体结构示意图。Figure 6 is a schematic view showing the structure of a catheter tube body of the present invention.
图7-1是本发明的手柄结构示意图。Figure 7-1 is a schematic view of the structure of the handle of the present invention.
图7-2是本发明的手柄右视图。Figure 7-2 is a right side view of the handle of the present invention.
图7-3是本发明的手柄左视图。Figure 7-3 is a left side view of the handle of the present invention.
图7-4是本发明的手柄手扳示意图。Figure 7-4 is a schematic view of the handle of the handle of the present invention.
图8是本发明的手术示例消融线示意图。Figure 8 is a schematic illustration of a surgical example ablation line of the present invention.
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详细说明。The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.
如图1所示,本发明实施例的肾动脉射频消融可控电极导管,从远端至近端,由消融电极1、监测电极2、导管管体3、操控手柄4顺序连接。操控手柄4近端伸出有导线延长线7,导线延长线7的近端与连接器8电连接,操控手柄4近端连接有冷盐水连接管9,冷盐水连接管9近端连接接头10。操控手柄4近端为托柄5,托柄5的中部设有手扳6,用于调节导管管体3远端弯曲和旋转的角度。导管管体3近端外缘设有白色的深度标记标尺11,用于观察控制肾动脉射频消融可控电极导管进入射频消融部位的深度。As shown in FIG. 1, the renal artery radiofrequency ablation controllable electrode catheter of the embodiment of the present invention is sequentially connected from the distal end to the proximal end by the ablation electrode 1, the monitoring electrode 2, the catheter tube body 3, and the manipulation handle 4. A proximal end of the control handle 4 is extended with a wire extension line 7. The proximal end of the wire extension wire 7 is electrically connected to the connector 8. The proximal end of the control handle 4 is connected with a cold brine connection pipe 9, and the cold brine connection pipe 9 is connected to the proximal end connector 10. . The proximal end of the manipulation handle 4 is a handle 5, and a middle portion of the handle 5 is provided with a hand lever 6 for adjusting the angle of bending and rotation of the distal end of the catheter tube 3. A white depth marking scale 11 is provided on the proximal edge of the catheter tube 3 for observing the depth of control of the renal artery radiofrequency ablation of the controllable electrode into the radiofrequency ablation site.
导管管体3近端连接操控手柄4,可以控制导管管体3远端部分的偏转。导管管体3内部有一贯通至消融电极的通道用于盐水灌注,盐水从近端的接头10进入导管管体3,从消融电极1上的冷盐水灌注孔14流出,对消融电极1进行充分的冷却,提高消融功率,有效去除交感神经。也可不用盐水灌注,用于打断比较浅表的心电,神经元传导。The proximal end of the catheter tube 3 is coupled to the steering handle 4 to control the deflection of the distal portion of the catheter tube 3. The inside of the catheter tube 3 has a passage through the ablation electrode for saline infusion, and the saline enters the catheter tube 3 from the proximal joint 10, and flows out from the cold saline perfusion hole 14 on the ablation electrode 1, and the ablation electrode 1 is fully performed. Cooling, increasing ablation power, effectively removing sympathetic nerves. It can also be used without perfusion of saline to interrupt the superficial ECG and transmit neurons.
如图2所示,消融电极1采用铂铱合金空心棒或管12,消融电极1外径1mm-2.67mm,长1mm-4mm,本实施例外径1.25mm,长1.6mm,远端端部为圆弧形状13。消融电极1上开有1-20个孔径为0.1mm-0.4mm的冷盐水灌注孔14, 本实施例为9个,采用深圳大族激光公司生产的精密激光器加工而成,其中3个冷盐水灌注孔均匀分布在消融电极1远端端部,6个冷盐水灌注孔均匀分布在消融电极中部的管壁上,孔心距离远端端部1mm。As shown in FIG. 2, the ablation electrode 1 adopts a platinum-iridium alloy hollow rod or tube 12, and the ablation electrode 1 has an outer diameter of 1 mm to 2.67 mm and a length of 1 mm to 4 mm. The outer diameter of the embodiment is 1.25 mm and the length is 1.6 mm, and the distal end portion is Arc shape 13. The ablation electrode 1 has 1-20 cold brine perfusion holes 14 with a pore diameter of 0.1 mm-0.4 mm. In this embodiment, nine are processed by a precision laser produced by Shenzhen Dazu Laser Co., Ltd., wherein three cold brine perfusion holes are uniformly distributed at the distal end of the ablation electrode 1, and six cold saline perfusion holes are evenly distributed in the middle of the ablation electrode. On the wall of the tube, the center of the hole is 1 mm from the distal end.
如图3-1所示,消融电极1的近端设有环状的监测电极2,监测电极2与测温元件线15电连接。如图3-2所示,监测电极2内装有测温元件16,测温元件16设置在监测电极2环内沿轴向的凹槽17内。监测电极2外径1mm-2.67mm,长0.4mm-1mm,用于测量温度、测量传导交感神经电位。本实施例外径1.33mm,长0.6mm,测温元件是热电偶。As shown in FIG. 3-1, the proximal end of the ablation electrode 1 is provided with an annular monitoring electrode 2, and the monitoring electrode 2 is electrically connected to the temperature measuring element line 15. As shown in FIG. 3-2, the monitoring electrode 2 is provided with a temperature measuring element 16 which is disposed in the groove 17 in the axial direction of the monitoring electrode 2. The monitoring electrode 2 has an outer diameter of 1 mm to 2.67 mm and a length of 0.4 mm to 1 mm for measuring temperature and measuring conduction sympathetic potential. The outer diameter of the embodiment is 1.33 mm and the length is 0.6 mm, and the temperature measuring element is a thermocouple.
消融电极1内连接有输送射频能量的导线18,导线18的远端与消融电极1电连接。冷盐水连接管9的远端至消融电极1。A wire 18 for transmitting radio frequency energy is connected to the ablation electrode 1, and the distal end of the wire 18 is electrically connected to the ablation electrode 1. The cold saline is connected to the distal end of the tube 9 to the ablation electrode 1.
如图4所示,监测电极2与消融电极1沿轴向之间的间隔19为0.2mm-2mm, 本实施例为0.5mm。As shown in Fig. 4, the interval 19 between the monitoring electrode 2 and the ablation electrode 1 in the axial direction is 0.2 mm - 2 mm, which is 0.5 mm in this embodiment.
射频消融是通过肾动脉管壁上的交感神经组织温度的升高而实现的,当温度达到50℃时,神经细胞会坏死,因此交感神经组织温度达到50℃以上,是实现有效消融的标志。在射频消融的过程中,温度是以消融电极1为中心向外辐射,如图5所示,消融区域也是以消融电极1为中心向外呈辐射状扩展,温度达到50℃以上的组织区域即为有效消融区。因此可以通过监测消融电极1周围组织的温度来了解真实消融区域的大小,从而决定是否中止射频消融。Radiofrequency ablation is achieved by an increase in the temperature of the sympathetic nerve tissue on the wall of the renal artery. When the temperature reaches 50 ° C, the nerve cells will be necrotic, so the temperature of the sympathetic nerve tissue reaches 50 ° C or above, which is a sign of effective ablation. In the process of radiofrequency ablation, the temperature is radiated outwardly around the ablation electrode 1. As shown in Fig. 5, the ablation region is also radially expanded outward from the ablation electrode 1, and the tissue region having a temperature of 50 ° C or higher is For effective ablation zone. It is therefore possible to determine the size of the true ablation zone by monitoring the temperature of the tissue surrounding the ablation electrode 1 to determine whether to abort the radiofrequency ablation.
本实施例在距离消融电极0.5mm的近端位置设有沿轴线长0.6mm的环状的监测电极2,其内装有热电偶,用以监测消融电极1周围交感神经组织的温度。当监测电极2测得的温度达到50℃时,说明沿轴线方向距离消融电极近端1.1mm(监测电极与消融电极之间的间隔0.5mm+监测电极长度0.6mm=1.1mm)处的温度已经达到50℃,此时,有效的射频消融区域为:沿轴线的长度区域为3.8mm(消融电极长1.6mm+距离消融电极1.1mm×2=3.8mm),垂直轴线的区域为Φ3.45mm(消融电极直径1.25mm+1.1mm×2=Φ3.45mm),也就是说本实施例消融电极的每一消融点的有效消融区域为3.8mm×Φ3.45mm。结合术前患者的CT、MR血管造影或肾多普勒成像结果测量肾动脉的尺寸,可以决定手术中的消融点数,整个消融过程按每点的有效区域,在肾动脉内形成一条完整的消融线。In this embodiment, an annular monitoring electrode 2 having a length of 0.6 mm along the axis is provided at a proximal end position of 0.5 mm from the ablation electrode, and a thermocouple is mounted therein for monitoring the temperature of the sympathetic nerve tissue around the ablation electrode 1. When the temperature measured by the monitoring electrode 2 reaches 50 ° C, it indicates that the temperature at the proximal end of the ablation electrode is 1.1 mm (the interval between the monitoring electrode and the ablation electrode is 0.5 mm + the length of the monitoring electrode is 0.6 mm = 1.1 mm) has reached the axial direction. At 50 ° C, at this time, the effective radiofrequency ablation zone is: 3.8 mm along the length of the axis (1.6 mm for the ablation electrode + 1.1 mm × 2 = 3.8 mm for the ablation electrode), and the area of the vertical axis is Φ 3.45 mm (ablation electrode) The diameter of 1.25 mm + 1.1 mm × 2 = Φ 3.45 mm), that is, the effective ablation area of each ablation point of the ablation electrode of the present embodiment is 3.8 mm × Φ 3.45 mm. Combined with the CT, MR angiography or renal Doppler imaging results of preoperative patients, the size of the renal artery can be measured, and the number of ablation points in the operation can be determined. The entire ablation process forms a complete ablation in the renal artery according to the effective area of each point. line.
如图6所示,导管管体3长750mm-1500mm,外径1.33mm-2.67mm,内径0.50mm-1.50mm。本实施例导管管体长850mm,外径1.67mm,内径1.50mm。导管管体3与现有技术的介入管体材料一样,采用生物相容性好的高分子材料组成,构成的导管管体从近端到远端硬度由硬逐渐变化到软,与现有技术不同的是本实施例导管管体3的近端采用不锈钢管20,保证导管的扭转性能接近1:1。导管管体3的中间部分采用聚四氟乙烯管21与不锈钢丝网22的复合管,保证导管具有柔韧性,导管管体3的远端采用尼龙弹性体23。通过操作近端的操控手柄4,导管远端靠近监测电极2处6-75mm段可弯曲。导管近端不锈钢管20上带有白色的深度标记标尺11,用于精确控制肾动脉射频消融可控电极导管进入射频消融部位的深度。As shown in Fig. 6, the catheter tube body 3 is 750 mm to 1500 mm long, and has an outer diameter of 1.33 mm to 2.67 mm and an inner diameter of 0.50 mm to 1.50 mm. The catheter tube body of this embodiment has a length of 850 mm, an outer diameter of 1.67 mm, and an inner diameter of 1.50 mm. The catheter tube body 3 is composed of a biocompatible polymer material, and the hardness of the catheter tube body from the proximal end to the distal end is gradually changed from soft to soft, and the prior art is the same as the prior art intervening tube material. The difference is that the proximal end of the catheter tube 3 of the present embodiment uses a stainless steel tube 20 to ensure that the torsional performance of the catheter is close to 1:1. The middle portion of the duct body 3 is a composite tube of a Teflon tube 21 and a stainless steel mesh 22 to ensure flexibility of the catheter, and the distal end of the catheter tube 3 is made of a nylon elastomer 23. By operating the proximal handle 4, the distal end of the catheter is bendable 6-75 mm near the monitoring electrode 2. The catheter proximal stainless steel tube 20 has a white depth marking scale 11 for precise control of the depth of the renal artery radiofrequency ablation controllable electrode into the radiofrequency ablation site.
如图7-1、图7-2、图7-3和图7-4所示,操控手柄4由远端的旋转柄51和近端的托柄5两部分连接组成。旋转柄51用于连接导管管体3,旋转柄51上设有一手扳6,用于将导管旋转到适当的角度,前后扳动手扳6可调节导管管体3远端6mm-75mm处弯曲或伸直。托柄5用于固定导管旋转后的位置,本实施例操控手柄4可旋转至三个位置:120°或60°,72°,180°或90°,分别用于沿圆周方向进行3点或6点,5点,2点或4点射频消融。操控手柄4的弯曲或伸直,旋转可以采用现有技术的结构。As shown in FIG. 7-1, FIG. 7-2, FIG. 7-3 and FIG. 7-4, the manipulation handle 4 is composed of a distal rotation knob 51 and a proximal handle 5 connected. The rotating handle 51 is used for connecting the catheter tube body 3. The rotating handle 51 is provided with a hand wrench 6 for rotating the catheter to an appropriate angle, and the front and rear lever 6 can adjust the bending of the distal end of the catheter tube body 6 mm-75 mm or Straighten out. The handle 5 is used to fix the position after the rotation of the catheter. In this embodiment, the manipulation handle 4 can be rotated to three positions: 120° or 60°, 72°, 180° or 90°, respectively for 3 points in the circumferential direction or 6, 5, 2 or 4 RF ablation. The handle 4 is bent or straightened, and the rotation can be made using the prior art structure.
手术示例 Surgical example
1、肾动脉射频消融仪1, renal artery radiofrequency ablation instrument
采用的肾动脉射频消融仪为专用消融仪,通过一条专用延长电缆与本发明的肾动脉射频消融可控电极导管连接。肾动脉射频消融仪的技术规格如下:The renal artery radiofrequency ablation instrument used is a dedicated ablation device connected to the renal artery radiofrequency ablation controllable electrode catheter of the present invention through a dedicated extension cable. The technical specifications of the renal artery radiofrequency ablation device are as follows:
频率 450-575千赫;Frequency 450-575 kHz;
电压 0-220伏;Voltage 0-220 volts;
电流 0-2.0安;Current 0-2.0 amp;
功率 最大15瓦;Power up to 15 watts;
阻抗切断限上限:500欧姆,下限:30欧姆;Upper limit of impedance cutoff limit: 500 ohms, lower limit: 30 ohms;
肾动脉射频消融仪的功率默认值为8W,调节精度±0.2W;温度默认值为41°C ,调节精度±1°C;阻抗切断限默认值为400欧姆;消融时间默认值为60秒,1-150秒可调。肾动脉射频消融仪可显示阻抗的变化及记录阻抗降低比率。The default value of the renal artery radiofrequency ablation device is 8W, the adjustment accuracy is ±0.2W; the temperature default is 41°C. The adjustment accuracy is ±1 °C; the impedance cutoff limit is 400 ohms by default; the default value of the ablation time is 60 seconds, adjustable from 1-150 seconds. The renal artery radiofrequency ablation device can display changes in impedance and record impedance reduction ratios.
2、盐水灌注泵2, saline perfusion pump
采用的盐水灌注泵流速调整范围:5-50ml/min,默认值为:10ml/min,低流速调整范围:1-5ml/min,默认值为:2ml/min。The brine perfusion pump flow rate adjustment range is 5-50ml/min, the default value is 10ml/min, the low flow rate adjustment range is 1-5ml/min, and the default value is 2ml/min.
3、手术对象选取经阉割的成年公猪,重量45kg -60kg,肾动脉血管最小尺寸为直径3.5mm、长度15mm。本手术示例选取45kg阉割的成年公猪。3, the surgical object select castrated adult boar, weight 45kg -60 kg, the smallest size of the renal artery is 3.5 mm in diameter and 15 mm in length. This surgery example selects 45 kg castrated adult boars.
4、肾动脉消融手术4, renal artery ablation surgery
在X光透视下,将猪尾导管沿导丝送至降主动脉靠近肾动脉。血管造影前注射硝酸甘油。根据注射的造影剂定量评估肾动脉的直径和长度以确定适当的射频消融点。撤出猪尾导管,沿导丝送入导引导管并将导引导管送入到肾动脉内,撤出导丝。Under X-ray, the pigtail catheter is delivered along the guidewire to the descending aorta near the renal artery. Inject nitroglycerin before angiography. The diameter and length of the renal artery are quantitatively assessed based on the injected contrast agent to determine the appropriate radiofrequency ablation point. The pigtail catheter is withdrawn, the guiding catheter is fed along the guide wire and the guiding catheter is delivered into the renal artery, and the guide wire is withdrawn.
按肾动脉的大小和长度选择合适的肾动脉消融导管,选择原则为:Select the appropriate renal artery ablation catheter according to the size and length of the renal artery. The selection principle is:
肾动脉直径3.5mm-4.5mm,选择导管远端6mm处弯曲的弯导管; The diameter of the renal artery is 3.5mm-4.5mm, and the curved catheter bent at the distal end of the catheter 6mm is selected;
肾动脉直径4.5mm-6mm,选择导管远端9mm处弯曲的弯导管; The diameter of the renal artery is 4.5mm-6mm, and the curved catheter bent at the distal end of the catheter is selected at 9mm;
肾动脉直径大于6mm,选择导管远端12mm处弯曲的弯导管。The diameter of the renal artery is greater than 6 mm, and a curved catheter bent at 12 mm distal to the catheter is selected.
肾动脉长度15mm-19mm或超过30mm,选择120°或60°,操控手柄行3点或6点消融;The length of the renal artery is 15mm-19mm or more than 30mm, 120° or 60° is selected, and the handle handle is ablated at 3 or 6 o'clock;
肾动脉长度25mm-29mm,选择72°,操控手柄行5点消融; The length of the renal artery is 25mm-29mm, 72° is selected, and the handle is ablated at 5 o'clock;
肾动脉长度10mm-14mm或20mm-24mm,选择180°或90°,操控手柄行2点或4点消融。The length of the renal artery is 10mm-14mm or 20mm-24mm. Choose 180° or 90°, and the handle will be ablated at 2 or 4 o'clock.
将肾动脉射频消融可控电极导管与肾动脉射频消融仪和盐水灌注泵连接,启动盐水灌注泵以10ml/min速度高速灌注,直至将导管内的空气全部排出,再将盐水灌注泵调至2ml/min的低速灌注。保持低速灌注及肾动脉消融导管远端伸直状态,经导引导管腔内将肾动脉射频消融可控电极导管送入肾动脉内,在X光透视下将消融电极送入到肾动脉最远端符合消融条件的部位,符合消融条件的部位为血管直径≥3.5mm。扳动手扳调节导管管体远端弯曲使消融电极贴靠到肾动脉壁上,观察阻抗是否合适,启动肾动脉射频消融仪消融,设置消融参数为:功率8W,时间45S,盐水灌注泵流量10ml/min,消融电极温度41℃,监测电极设定温度50℃,观察并记录消融过程中功率、温度、阻抗的变化,交感神经组织温度(温度P)达到设定值立即切断肾动脉射频消融仪,调整导管管体位置,进行下一点消融。The renal artery radiofrequency ablation controllable electrode catheter was connected with the renal artery radiofrequency ablation instrument and the saline perfusion pump, and the saline perfusion pump was started to perfuse at a high speed of 10 ml/min until the air in the catheter was completely discharged, and then the saline perfusion pump was adjusted to 2 ml. Low-speed perfusion of /min. Maintaining the low-speed perfusion and the distal extremity of the renal artery ablation catheter, the radiofrequency catheter ablation of the renal artery into the renal artery through the guiding catheter lumen, and the ablation electrode is sent to the renal artery farthest under X-ray fluoroscopy The site that meets the ablation conditions at the end, the site that meets the ablation conditions is the vessel diameter ≥ 3.5 mm. Pull the hand to adjust the distal end of the catheter tube to bend the ablation electrode to the renal artery wall, observe whether the impedance is appropriate, start the renal artery radiofrequency ablation instrument ablation, set the ablation parameters: power 8W, time 45S, saline perfusion pump flow 10ml /min, ablation electrode temperature 41 ° C, monitoring electrode set temperature 50 ° C, observe and record changes in power, temperature, impedance during ablation, sympathetic nerve tissue temperature (temperature P) reaches the set value immediately cut off renal artery radiofrequency ablation Adjust the position of the catheter tube for the next ablation.
完成第一点消融后,调整导管管体位置,扳动手扳至回复位置调节导管管体远端伸直,将导管回撤一个3mm深度标记,操作者左手握住托柄,右手将旋转柄顺时针方向旋转一个角度,再扳动手扳调节导管前端弯曲使消融电极贴靠到肾动脉壁上,重复上述消融过程,进行第二点消融。重复以上过程直至完成整条肾动脉消融。After the first ablation is completed, adjust the position of the catheter tube, pull the hand to the return position to adjust the distal end of the catheter tube, and retract the catheter with a 3mm depth mark. The operator holds the handle with the left hand and the right hand rotates the handle. Rotate an angle in the hour hand direction, and then pull the hand to adjust the front end of the catheter to bend the ablation electrode against the renal artery wall, repeat the above ablation process, and perform the second ablation. Repeat the above procedure until the entire renal artery is ablated.
5、结果5, the results
手术结束后,缝合股动脉穿刺口,手术切口亦需缝合。对实验对象(公猪)注射过剂量安死液或氯化钾IV号溶液对动物实施安乐死。安乐死之后,收集实验动物的肾动脉,沿肾动脉长度方向剖开肾动脉后观察,可见到损伤为螺旋状,如图8所示,沿肾动脉的横截面切成若干片状,可在肾动脉内壁上见到周长为12mm-24mm的完整圆筒形烧伤。After the end of the operation, the femoral artery puncture is sutured and the surgical incision is also sutured. Animals were euthanized by injection of a dose of ampoules or potassium chloride IV solution into the subject (boar). After euthanasia, the renal artery of the experimental animal was collected, and the renal artery was dissected along the length of the renal artery. The lesion was spiraled. As shown in Fig. 8, the cross section of the renal artery was cut into several pieces, which were in the kidney. A complete cylindrical burn with a circumference of 12 mm to 24 mm was seen on the inner wall of the artery.
本发明的电极成组设置,每组包括有消融电极和监测电极,导管管体远端可沿轴线设置有1组以上的电极。本实施例为1组,一个消融电极和一个监测电极导管。消融电极上没有灌注孔,监测电极为环状,经间隔邻消融电极,监测距离消融电极0.5-2.5mm处交感神经组织的温度,从而监测消融区域的温度。每个监测电极内部都装有测温元件热电偶或热敏电阻,在消融过程中监测被消融的交感神经组织的温度,以判断达到临床治疗要求值,确定消融终点,以确保有效消融,并减少对血管内壁的损伤,保护了血管。克服了现有技术的导管仅能测量消融电极的温度,这个温度是消融区域中心的温度,而不是消融区边缘组织的温度,不能监测消融区域的大小的缺陷。监测电极还可与电生理仪器相连,监测交感神经信号的传导,对比消融前后交感神经传导波形,辅助判断手术终点是否完成,本发明解决了现有技术的导管临床手术无终点的问题。现有技术在临床上心律不齐广泛应用的射频消融术治疗后,存在20%左右的复发率,异常传导没有彻底打断,本发明的结构也可用于心脏射频消融术,监控消融区组织温度,彻底打断心电的异常传导,确保消融有效,大大降低复发率。The electrodes of the present invention are arranged in groups, each group comprising an ablation electrode and a monitoring electrode, and the distal end of the catheter tube body may be provided with more than one set of electrodes along the axis. This embodiment is a group, an ablation electrode and a monitoring lead. There is no perfusion hole on the ablation electrode, and the monitoring electrode is annular. The temperature of the sympathetic nerve tissue at 0.5-2.5 mm from the ablation electrode is monitored by the interval ablation electrode to monitor the temperature of the ablation zone. Each monitoring electrode is equipped with a temperature measuring element thermocouple or thermistor, and the temperature of the ablated sympathetic nerve tissue is monitored during the ablation process to determine the clinical treatment requirement value, and the ablation end point is determined to ensure effective ablation, and Reduces damage to the inner wall of blood vessels and protects blood vessels. A catheter that overcomes the prior art can only measure the temperature of the ablation electrode, which is the temperature at the center of the ablation zone, rather than the temperature of the tissue at the edge of the ablation zone, and cannot detect the size of the ablation zone. The monitoring electrode can also be connected with the electrophysiological instrument to monitor the conduction of the sympathetic nerve signal, compare the sympathetic nerve conduction waveform before and after the ablation, and assist in judging whether the surgical end point is completed. The invention solves the problem that the prior art catheter has no end point in clinical operation. In the prior art, after radiofrequency ablation, which is widely used in clinical arrhythmia, there is a recurrence rate of about 20%, and the abnormal conduction is not completely interrupted. The structure of the present invention can also be used for cardiac radiofrequency ablation, monitoring the tissue temperature of the ablation zone. It completely interrupts the abnormal conduction of ECG, ensures effective ablation, and greatly reduces the recurrence rate.

Claims (10)

  1. 一种肾动脉射频消融可控电极导管,设有导管管体(3),导管管体(3)的远端连接有电极,近端连接有操控手柄(4),其特征在于:所述电极为消融电极(1)和监测电极(2)。 A renal artery radiofrequency ablation controllable electrode catheter is provided with a catheter tube body (3), a distal end of the catheter tube body (3) is connected with an electrode, and a proximal end is connected with a manipulation handle (4), characterized in that the electrode It is the ablation electrode (1) and the monitoring electrode (2).
  2. 根据权利要求1所述的肾动脉射频消融可控电极导管,其特征在于:所述消融电极(1)和监测电极(2)沿导管管体(3)的轴线设置在远端,消融电极(1)和监测电极(2)之间设有间隔(19)。The renal artery radiofrequency ablation controllable electrode catheter according to claim 1, wherein the ablation electrode (1) and the monitoring electrode (2) are disposed at a distal end along the axis of the catheter tube (3), and the ablation electrode ( 1) A space (19) is provided between the monitoring electrode (2).
  3. 根据权利要求2所述的肾动脉射频消融可控电极导管,其特征在于:所述消融电极(1)采用铂铱合金空心棒或管(12),远端端部为圆弧形状(13),消融电极(1)上开有冷盐水灌注孔(14)。The renal artery radiofrequency ablation controllable electrode catheter according to claim 2, wherein the ablation electrode (1) is a platinum-iridium alloy hollow rod or tube (12), and the distal end portion has a circular arc shape (13) The ablation electrode (1) is provided with a cold saline perfusion hole (14).
  4. 根据权利要求3所述的肾动脉射频消融可控电极导管,其特征在于:所述消融电极(1)外径1mm-2.67mm,长1mm-4mm,冷盐水灌注孔(14)为1-20个,孔径为0.1mm-0.4mm,分布于消融电极(1)的远端端部和管壁上。The renal artery radiofrequency ablation controllable electrode catheter according to claim 3, wherein the ablation electrode (1) has an outer diameter of 1 mm to 2.67 mm, a length of 1 mm to 4 mm, and a cold saline perfusion hole (14) of 1 to 20 The aperture is from 0.1 mm to 0.4 mm and is distributed over the distal end of the ablation electrode (1) and the wall of the tube.
  5. 根据权利要求4所述的肾动脉射频消融可控电极导管,其特征在于:所述监测电极(2)为环状,外径1mm-2.67mm,长0.4mm-1mm。The renal artery radiofrequency ablation controllable electrode catheter according to claim 4, wherein the monitoring electrode (2) is annular, having an outer diameter of 1 mm to 2.67 mm and a length of 0.4 mm to 1 mm.
  6. 根据权利要求5所述的肾动脉射频消融可控电极导管,其特征在于:所述监测电极(2)内装有测温元件(16)。The renal artery radiofrequency ablation controllable electrode catheter according to claim 5, characterized in that the monitoring electrode (2) is provided with a temperature measuring element (16).
  7. 根据权利要求6所述的肾动脉射频消融可控电极导管,其特征在于:所述测温元件(16)设置在监测电极(2)环内沿轴向的凹槽(17)内。The renal artery radiofrequency ablation controllable electrode catheter according to claim 6, wherein the temperature measuring element (16) is disposed in the axial groove (17) in the ring of the monitoring electrode (2).
  8. 根据权利要求2所述的肾动脉射频消融可控电极导管,其特征在于:所述间隔(19)为0.2mm-2mm。The renal artery radiofrequency ablation controllable electrode catheter according to claim 2, wherein the interval (19) is 0.2 mm to 2 mm.
  9. 根据权利要求7所述的肾动脉射频消融可控电极导管,其特征在于:所述消融电极(1)外径1.25mm,长1.6mm,消融电极(1)上开有9个冷盐水灌注孔(14),其中3个冷盐水灌注孔均匀分布在电极端部,6个冷盐水灌注孔均匀分布在消融电极中部的管壁上;所述监测电极(2)外径1.33mm,长0.6mm;所述测温元件是热电偶;所述间隔(19)为0.5mm。The renal artery radiofrequency ablation controllable electrode catheter according to claim 7, wherein the ablation electrode (1) has an outer diameter of 1.25 mm and a length of 1.6 mm, and the ablation electrode (1) has nine cold saline perfusion holes. (14), wherein three cold brine perfusion holes are evenly distributed at the end of the electrode, and six cold brine perfusion holes are evenly distributed on the tube wall in the middle of the ablation electrode; the monitoring electrode (2) has an outer diameter of 1.33 mm and a length of 0.6 mm. The temperature measuring element is a thermocouple; the spacing (19) is 0.5 mm.
  10. 根据权利要求1所述的肾动脉射频消融可控电极导管,其特征在于:所述操控手柄(4)调节导管导管管体(3)远端6mm-75mm处弯曲或伸直,旋转至120°或60°,72°,180°或90°位置。The renal artery radiofrequency ablation controllable electrode catheter according to claim 1, wherein the manipulation handle (4) adjusts the distal end of the catheter catheter tube (3) to be bent or straightened at a distance of 6 mm to 75 mm, and is rotated to 120°. Or 60°, 72°, 180° or 90° position.
PCT/CN2012/079947 2012-07-18 2012-08-10 Controllable renal artery radio-frequency ablation electrode catheter WO2014012282A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201210249132.9 2012-07-18
CN201210249132.9A CN102743225B (en) 2012-07-18 2012-07-18 Radiofrequency ablation controlled electrode catheter for renal artery

Publications (1)

Publication Number Publication Date
WO2014012282A1 true WO2014012282A1 (en) 2014-01-23

Family

ID=47023974

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2012/079947 WO2014012282A1 (en) 2012-07-18 2012-08-10 Controllable renal artery radio-frequency ablation electrode catheter

Country Status (2)

Country Link
CN (1) CN102743225B (en)
WO (1) WO2014012282A1 (en)

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8998894B2 (en) 2010-10-25 2015-04-07 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses having multi-electrode arrays for renal neuromodulation and associated systems and methods
US9066720B2 (en) 2010-10-25 2015-06-30 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US9084610B2 (en) 2010-10-21 2015-07-21 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses, systems, and methods for renal neuromodulation
US9125661B2 (en) 2002-04-08 2015-09-08 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US9131978B2 (en) 2002-04-08 2015-09-15 Medtronic Ardian Luxembourg S.A.R.L. Methods for bilateral renal neuromodulation
US9326816B2 (en) 2013-08-30 2016-05-03 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation systems having nerve monitoring assemblies and associated devices, systems, and methods
US9327123B2 (en) 2011-11-07 2016-05-03 Medtronic Ardian Luxembourg S.A.R.L. Endovascular nerve monitoring devices and associated systems and methods
US9339332B2 (en) 2013-08-30 2016-05-17 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods
US9345538B2 (en) 2005-07-22 2016-05-24 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for neuromodulation for treatment of disorders associated with nerve conduction
US9510777B2 (en) 2012-03-08 2016-12-06 Medtronic Ardian Luxembourg S.A.R.L. Monitoring of neuromodulation using biomarkers
US10166069B2 (en) 2014-01-27 2019-01-01 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters having jacketed neuromodulation elements and related devices, systems, and methods
US10188829B2 (en) 2012-10-22 2019-01-29 Medtronic Ardian Luxembourg S.A.R.L. Catheters with enhanced flexibility and associated devices, systems, and methods
US10231784B2 (en) 2016-10-28 2019-03-19 Medtronic Ardian Luxembourg S.A.R.L. Methods and systems for optimizing perivascular neuromodulation therapy using computational fluid dynamics
US10368775B2 (en) 2014-10-01 2019-08-06 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for evaluating neuromodulation therapy via hemodynamic responses
US10537385B2 (en) 2008-12-31 2020-01-21 Medtronic Ardian Luxembourg S.A.R.L. Intravascular, thermally-induced renal neuromodulation for treatment of polycystic ovary syndrome or infertility
US10543037B2 (en) 2013-03-15 2020-01-28 Medtronic Ardian Luxembourg S.A.R.L. Controlled neuromodulation systems and methods of use
US10548663B2 (en) 2013-05-18 2020-02-04 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters with shafts for enhanced flexibility and control and associated devices, systems, and methods
US10610292B2 (en) 2014-04-25 2020-04-07 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems, and methods for monitoring and/or controlling deployment of a neuromodulation element within a body lumen and related technology
US10667736B2 (en) 2014-12-17 2020-06-02 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for assessing sympathetic nervous system tone for neuromodulation therapy
CN111407397A (en) * 2020-03-24 2020-07-14 苏州朗开医疗技术有限公司 Lung cancer treatment radio frequency ablation electrode catheter
US10736690B2 (en) 2014-04-24 2020-08-11 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters and associated systems and methods
CN111904589A (en) * 2020-07-08 2020-11-10 上海恩逖医疗科技有限公司 Outside confession liquid radio frequency plasma scalpel head and scalpel thereof
US11154712B2 (en) 2014-08-28 2021-10-26 Medtronic Ardian Luxembourg S.A.R.L. Methods for assessing efficacy of renal neuromodulation and associated systems and devices
CN113616318A (en) * 2021-09-06 2021-11-09 上海康德莱医疗器械股份有限公司 Renal sympathetic nerve ablation system and method
US11432870B2 (en) 2016-10-04 2022-09-06 Avent, Inc. Cooled RF probes
CN115414108A (en) * 2022-08-12 2022-12-02 洲瓴(上海)医疗器械有限公司 Linear type pulse ablation device
US11633120B2 (en) 2018-09-04 2023-04-25 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for assessing efficacy of renal neuromodulation therapy

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8774913B2 (en) 2002-04-08 2014-07-08 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for intravasculary-induced neuromodulation
CN103027750B (en) * 2012-11-23 2015-02-11 刘宗军 Electrical ablation balloon radiofrequency catheter in percutaneous renal artery
KR101459941B1 (en) * 2013-08-23 2014-11-07 고려대학교 산학협력단 Multi-electrode catheter for mapping and ablating lesion parts
CN103654948B (en) * 2013-11-12 2016-08-17 上海慧达医疗器械有限公司 A kind of two pole band Pressure wire radio frequency ablation catheter for renal arteries
US11478298B2 (en) 2018-01-24 2022-10-25 Medtronic Ardian Luxembourg S.A.R.L. Controlled irrigation for neuromodulation systems and associated methods
CN112638301A (en) * 2018-08-13 2021-04-09 悉尼大学 Catheter ablation device with impedance monitoring
CN113040897B (en) * 2019-12-26 2022-07-26 上海微创电生理医疗科技股份有限公司 Medical intervention formula pipe
CN115463308A (en) * 2022-09-15 2022-12-13 上海微创医疗器械(集团)有限公司 Medical intervention catheter
CN115337094B (en) * 2022-10-20 2023-01-31 北京晨息医疗科技有限公司 Retronasal nerve ablation device and retronasal nerve ablation device thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5545161A (en) * 1992-12-01 1996-08-13 Cardiac Pathways Corporation Catheter for RF ablation having cooled electrode with electrically insulated sleeve
US20080097425A1 (en) * 2005-03-24 2008-04-24 Csaba Truckai Electrosurgical ablation apparatus and method
WO2009155526A2 (en) * 2008-06-20 2009-12-23 Angiodynamics, Inc. Device and method for the ablation of fibrin sheath formation on a venous catheter
CN101647725A (en) * 2009-08-21 2010-02-17 成正辉 Rapid linear radio-frequency ablation electrode
CN102274074A (en) * 2011-05-03 2011-12-14 上海微创电生理医疗科技有限公司 Multi-electrode open-type radio frequency ablation catheter
WO2012058434A1 (en) * 2010-10-27 2012-05-03 Boston Scientific Scimed, Inc. Rf renal denervation catheter with multiple independent electrodes

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5545161A (en) * 1992-12-01 1996-08-13 Cardiac Pathways Corporation Catheter for RF ablation having cooled electrode with electrically insulated sleeve
US20080097425A1 (en) * 2005-03-24 2008-04-24 Csaba Truckai Electrosurgical ablation apparatus and method
WO2009155526A2 (en) * 2008-06-20 2009-12-23 Angiodynamics, Inc. Device and method for the ablation of fibrin sheath formation on a venous catheter
CN101647725A (en) * 2009-08-21 2010-02-17 成正辉 Rapid linear radio-frequency ablation electrode
WO2012058434A1 (en) * 2010-10-27 2012-05-03 Boston Scientific Scimed, Inc. Rf renal denervation catheter with multiple independent electrodes
CN102274074A (en) * 2011-05-03 2011-12-14 上海微创电生理医疗科技有限公司 Multi-electrode open-type radio frequency ablation catheter

Cited By (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9675413B2 (en) 2002-04-08 2017-06-13 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US10245429B2 (en) 2002-04-08 2019-04-02 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US9125661B2 (en) 2002-04-08 2015-09-08 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US9131978B2 (en) 2002-04-08 2015-09-15 Medtronic Ardian Luxembourg S.A.R.L. Methods for bilateral renal neuromodulation
US9289255B2 (en) 2002-04-08 2016-03-22 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US11033328B2 (en) 2002-04-08 2021-06-15 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for renal neuromodulation
US9345538B2 (en) 2005-07-22 2016-05-24 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for neuromodulation for treatment of disorders associated with nerve conduction
US10561460B2 (en) 2008-12-31 2020-02-18 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation systems and methods for treatment of sexual dysfunction
US10537385B2 (en) 2008-12-31 2020-01-21 Medtronic Ardian Luxembourg S.A.R.L. Intravascular, thermally-induced renal neuromodulation for treatment of polycystic ovary syndrome or infertility
US9084610B2 (en) 2010-10-21 2015-07-21 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses, systems, and methods for renal neuromodulation
US9636173B2 (en) 2010-10-21 2017-05-02 Medtronic Ardian Luxembourg S.A.R.L. Methods for renal neuromodulation
US9855097B2 (en) 2010-10-21 2018-01-02 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses, systems, and methods for renal neuromodulation
US10342612B2 (en) 2010-10-21 2019-07-09 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses, systems, and methods for renal neuromodulation
US11006999B2 (en) 2010-10-25 2021-05-18 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US9345530B2 (en) 2010-10-25 2016-05-24 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US8998894B2 (en) 2010-10-25 2015-04-07 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses having multi-electrode arrays for renal neuromodulation and associated systems and methods
US9066720B2 (en) 2010-10-25 2015-06-30 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US9750560B2 (en) 2010-10-25 2017-09-05 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems and methods for evaluation and feedback of neuromodulation treatment
US9327123B2 (en) 2011-11-07 2016-05-03 Medtronic Ardian Luxembourg S.A.R.L. Endovascular nerve monitoring devices and associated systems and methods
US9510777B2 (en) 2012-03-08 2016-12-06 Medtronic Ardian Luxembourg S.A.R.L. Monitoring of neuromodulation using biomarkers
US10729365B2 (en) 2012-03-08 2020-08-04 Medtronic Ardian Luxembourg S.A.R.L. Biomarker sampling in the context of neuromodulation devices, systems, and methods
US11338140B2 (en) 2012-03-08 2022-05-24 Medtronic Ardian Luxembourg S.A.R.L. Monitoring of neuromodulation using biomarkers
US10368791B2 (en) 2012-03-08 2019-08-06 Medtronic Adrian Luxembourg S.a.r.l. Devices and associated methods for monitoring of neuromodulation using biomarkers
US9597018B2 (en) 2012-03-08 2017-03-21 Medtronic Ardian Luxembourg S.A.R.L. Biomarker sampling in the context of neuromodulation devices, systems, and methods
US10188829B2 (en) 2012-10-22 2019-01-29 Medtronic Ardian Luxembourg S.A.R.L. Catheters with enhanced flexibility and associated devices, systems, and methods
US11147948B2 (en) 2012-10-22 2021-10-19 Medtronic Ardian Luxembourg S.A.R.L. Catheters with enhanced flexibility and associated devices, systems, and methods
US10543037B2 (en) 2013-03-15 2020-01-28 Medtronic Ardian Luxembourg S.A.R.L. Controlled neuromodulation systems and methods of use
US10548663B2 (en) 2013-05-18 2020-02-04 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters with shafts for enhanced flexibility and control and associated devices, systems, and methods
US9931047B2 (en) 2013-08-30 2018-04-03 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods
US9339332B2 (en) 2013-08-30 2016-05-17 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters with nerve monitoring features for transmitting digital neural signals and associated systems and methods
US9326816B2 (en) 2013-08-30 2016-05-03 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation systems having nerve monitoring assemblies and associated devices, systems, and methods
US10292610B2 (en) 2013-08-30 2019-05-21 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation systems having nerve monitoring assemblies and associated devices, systems, and methods
US11154353B2 (en) 2014-01-27 2021-10-26 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters having jacketed neuromodulation elements and related devices, systems, and methods
US10166069B2 (en) 2014-01-27 2019-01-01 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters having jacketed neuromodulation elements and related devices, systems, and methods
US10736690B2 (en) 2014-04-24 2020-08-11 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters and associated systems and methods
US11464563B2 (en) 2014-04-24 2022-10-11 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters and associated systems and methods
US10610292B2 (en) 2014-04-25 2020-04-07 Medtronic Ardian Luxembourg S.A.R.L. Devices, systems, and methods for monitoring and/or controlling deployment of a neuromodulation element within a body lumen and related technology
US11154712B2 (en) 2014-08-28 2021-10-26 Medtronic Ardian Luxembourg S.A.R.L. Methods for assessing efficacy of renal neuromodulation and associated systems and devices
US11311205B2 (en) 2014-10-01 2022-04-26 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for evaluating neuromodulation therapy via hemodynamic responses
US10368775B2 (en) 2014-10-01 2019-08-06 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for evaluating neuromodulation therapy via hemodynamic responses
US10667736B2 (en) 2014-12-17 2020-06-02 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for assessing sympathetic nervous system tone for neuromodulation therapy
US11432870B2 (en) 2016-10-04 2022-09-06 Avent, Inc. Cooled RF probes
US10231784B2 (en) 2016-10-28 2019-03-19 Medtronic Ardian Luxembourg S.A.R.L. Methods and systems for optimizing perivascular neuromodulation therapy using computational fluid dynamics
US11311340B2 (en) 2016-10-28 2022-04-26 Medtronic Ardian Luxembourg S.A.R.L. Methods and systems for optimizing perivascular neuromodulation therapy using computational fluid dynamics
US11633120B2 (en) 2018-09-04 2023-04-25 Medtronic Ardian Luxembourg S.A.R.L. Systems and methods for assessing efficacy of renal neuromodulation therapy
CN111407397A (en) * 2020-03-24 2020-07-14 苏州朗开医疗技术有限公司 Lung cancer treatment radio frequency ablation electrode catheter
CN111904589A (en) * 2020-07-08 2020-11-10 上海恩逖医疗科技有限公司 Outside confession liquid radio frequency plasma scalpel head and scalpel thereof
CN113616318A (en) * 2021-09-06 2021-11-09 上海康德莱医疗器械股份有限公司 Renal sympathetic nerve ablation system and method
CN113616318B (en) * 2021-09-06 2022-05-20 上海康德莱医疗器械股份有限公司 Renal sympathetic nerve ablation system and method
CN115414108A (en) * 2022-08-12 2022-12-02 洲瓴(上海)医疗器械有限公司 Linear type pulse ablation device

Also Published As

Publication number Publication date
CN102743225A (en) 2012-10-24
CN102743225B (en) 2014-04-02

Similar Documents

Publication Publication Date Title
WO2014012282A1 (en) Controllable renal artery radio-frequency ablation electrode catheter
CN202386778U (en) Radio-frequency melting device
CA2846395C (en) System and method for locating and identifying functional nerves innervating wall of arteries and catheters for same
WO2014075415A1 (en) Multi-pole synchronous radiofrequency ablation catheter for pulmonary artery
CN202069688U (en) Radio frequency ablation electrode capable of treating resistant hypertension
WO2022199159A1 (en) Electrode device, ablation catheter, and ablation system
US20130116688A1 (en) Ablation catheter
CN202776541U (en) Controllable renal artery radiofrequency ablation electrode conduit
JP2008502427A (en) Ablation catheter and method of use
CA2799462A1 (en) Catheter with reversible adhesiveness, for stabilization during transcatheter ablation by means of radio frequency
US10413212B2 (en) Methods and systems for enhanced mapping of tissue
CN102688090A (en) Bidirectionally controllable saline-perfusion renal artery radiofrequency ablation catheter
CN103536352A (en) Balloon expanding renal artery sympathetic nerve ablation catheter
CN107374725B (en) Multipole ablation device
US20230172650A1 (en) Pulsed electric field waveform manipulation and use
CN106618727A (en) Vascular radio-frequency ablation electrode catheter provided with claw-shaped catheter branches
CN103300917A (en) Percutaneous coronary intervention radio frequency ablation electrode catheter
JPH08510154A (en) Catheter for various site tissue therapies
JP2003502105A (en) Submucosal high frequency tonsillectomy device
CN105615990A (en) Electrophysiology catheter
Heradien et al. First reported cases: renal denervation with secondgeneration multi-electrode catheter via brachial and radial access: case report
CN202589653U (en) Double-direction controllable saline infusion type renal artery radiofrequency ablation catheter
CN206896404U (en) A kind of blood vessel frequency ablation electrode catheter with claw-like brasnch conduct
CN111035447A (en) Radio frequency ablation device
CN117679149A (en) Telescopic spiral renal artery sympathetic nerve multipolar perfusion ablation catheter

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12881255

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 12881255

Country of ref document: EP

Kind code of ref document: A1