WO2014012282A1 - Cathéter à électrode d'ablation par radiofréquence d'artère rénale pouvant être commandé - Google Patents

Cathéter à électrode d'ablation par radiofréquence d'artère rénale pouvant être commandé Download PDF

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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
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Prior art keywords
electrode
ablation
renal artery
catheter
controllable
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Ceased
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PCT/CN2012/079947
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English (en)
Chinese (zh)
Inventor
吴书林
程晓曙
成正辉
韩永贵
郭怀球
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APT MEDICAL Inc
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APT MEDICAL Inc
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    • 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.

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PCT/CN2012/079947 2012-07-18 2012-08-10 Cathéter à électrode d'ablation par radiofréquence d'artère rénale pouvant être commandé Ceased WO2014012282A1 (fr)

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CN201210249132.9A CN102743225B (zh) 2012-07-18 2012-07-18 肾动脉射频消融可控电极导管
CN201210249132.9 2012-07-18

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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
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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
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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
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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 (zh) * 2020-03-24 2020-07-14 苏州朗开医疗技术有限公司 一种肺癌治疗射频消融电极导管
US10736690B2 (en) 2014-04-24 2020-08-11 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters and associated systems and methods
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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
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US11432870B2 (en) 2016-10-04 2022-09-06 Avent, Inc. Cooled RF probes
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CN115813533A (zh) * 2022-11-21 2023-03-21 成都百瑞恒通医疗科技有限公司 射频消融导管及射频消融装置
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