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WO2014075415A1 - 多极同步肺动脉射频消融导管 - Google Patents

多极同步肺动脉射频消融导管 Download PDF

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Publication number
WO2014075415A1
WO2014075415A1 PCT/CN2013/073338 CN2013073338W WO2014075415A1 WO 2014075415 A1 WO2014075415 A1 WO 2014075415A1 CN 2013073338 W CN2013073338 W CN 2013073338W WO 2014075415 A1 WO2014075415 A1 WO 2014075415A1
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WIPO (PCT)
Prior art keywords
wire
annular ring
pulmonary artery
ablation catheter
control handle
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Ceased
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PCT/CN2013/073338
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English (en)
French (fr)
Inventor
陈绍良
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Individual
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Individual
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Priority to BR112014007594-8A priority Critical patent/BR112014007594B1/pt
Priority to EP13840133.6A priority patent/EP2910213B1/en
Priority to KR1020147009077A priority patent/KR101640329B1/ko
Priority to RU2014112769/14A priority patent/RU2587945C9/ru
Priority to JP2014546305A priority patent/JP6054415B2/ja
Publication of WO2014075415A1 publication Critical patent/WO2014075415A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00166—Multiple lumina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00797—Temperature measured by multiple temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details 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
    • A61B2218/002—Irrigation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0021—Neural system treatment
    • A61N2007/003—Destruction of nerve tissue
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/041—Controlled or regulated

Definitions

  • the invention relates to a medical device for treating pulmonary hypertension in pulmonary artery desympathetic nerve therapy, in particular to a multi-pole synchronous pulmonary artery radiofrequency ablation catheter.
  • Pulmonary hypertension is a difficult disease of cardiovascular, respiratory, connective tissue, and immune rheumatism.
  • the clinical treatment is limited and the curative effect is extremely poor.
  • the incidence of primary pulmonary hypertension is low, but the incidence of pulmonary interstitial fibrosis, connective tissue disease, portal hypertension, chronic pulmonary embolism and left heart system disease is more common, with a mortality rate of 30% within 5 years. Therefore, active prevention and treatment of pulmonary hypertension is of great significance.
  • the invention provides a multi-pole synchronous pulmonary artery radiofrequency ablation catheter for pulmonary artery desympathetic nerve treatment for pulmonary hypertension.
  • the catheter only performs radiofrequency heating on the adherent tissue without heating the blood, and adopts a cold physiological saline perfusion method.
  • the protection of the intima of the blood vessel has the advantages of simple operation, short operation time, and accurate and controllable ablation.
  • the multi-pole synchronous pulmonary artery ablation catheter comprises a control handle, a tube body and an annular ring, and the control handle is provided with an adjusting device;
  • the tube body is a hollow structure, a cavity is arranged therein, and a wire and a temperature sensing line are arranged in the cavity
  • the traction wire the end of the pipe body has flexibility, the flexible end is connected with the annular ring, the other end of the pipe body is connected with the control handle, one end of the traction wire is connected with the flexible end, and the other end is connected with the adjusting device on the control handle, through
  • the adjusting device controls the tension of the traction wire to realize the arc control of the flexible end;
  • the annular ring is provided with a shape memory wire, one end of the shape memory wire extends to the distal end of the annular ring, and the other end is fixed through the root of the annular ring
  • the annular ring is provided with electrode groups, each of which is connected to a wire and a temperature
  • the tube body is provided with an infusion tube, and the electrode is provided with a through hole.
  • the infusion tube is connected to the electrode through the inside of the annular ring, and the liquid to be delivered flows out through the through hole.
  • the electrode on the annular ring is made of platinum-rhodium alloy, gold, stainless steel or nickel alloy material, the number is 3-30, the electrode diameter is 1.3-2.0 mm, the length is 1.2-4 mm, and the edge spacing of adjacent electrodes is 0.5-10mm.
  • the flexible end of the tubular body defines a counterbore, and the outer diameter of the root of the annular ring cooperates with the inner diameter of the counterbore, and the root of the annular ring is inserted into the counterbore and fixed.
  • the flexible end of the tubular body is provided with a groove, and a connecting member is arranged in the groove, and one end of the connecting member is connected with the pulling wire, and the other end is connected with the shape memory wire.
  • the shape memory wire material in the annular ring is a shape memory alloy
  • the shape memory alloy is nickel titanium alloy, stainless steel or titanium
  • the diameter thereof is 0.25-0.5 mm
  • the annular ring diameter is 12-40 mm.
  • 10 electrodes are arranged on the annular ring, and the exposed portion of the electrode has a width of 0.75 mm and a pitch of 5 mm.
  • the flexible end of the tube body is made of medical polymer material and has a length of 30-80 mm.
  • connection is by a UV-curable adhesive.
  • the traction wire is made of stainless steel or nickel-titanium alloy, the outer part of the traction wire is sleeved with a spring coil, and the outer sleeve of the spring ring is sleeved with a spring sleeve, and the spring sleeve is made of polyimide material.
  • the invention adopts the above technical solution, so that the catheter only performs radio frequency heating on the adherent tissue without heating the blood, and has the advantages of simple operation, short operation time, accurate and controllable ablation.
  • the catheter tube body is preferably made of a polymer material, and since the polymer material is a poor conductor of heat, it is possible to better prevent heat transfer from the electrode heating to the flowing blood in contact with the catheter tube body, thereby more effectively avoiding Heating of the blood.
  • the bending of the flexible end can be controlled by operating the adjustment device. This allows the operator to control the handle with one hand and conveniently adjust the curvature of the flexible end so that the electrodes on the annular ring can be sufficiently adhered to the pulmonary artery to achieve ablation of the pulmonary artery wall.
  • the electrode During the process of generating radio frequency current, the electrode locally generates a higher temperature and the damage to the intima of the blood vessel is heavier. To this end, the present invention also employs a method of perfusion of cold saline to achieve local cooling.
  • the electrode When the electrode generates a current, the physiological saline is uniformly diffused through the through hole uniformly, so that the local temperature is lower than 60 ° C, thereby protecting the intima of the blood vessel.
  • Figure 1 is a schematic view of the structure of the present invention
  • Figure 2 is a partial enlarged view of a portion B of the present invention.
  • Figure 3 is a cross-sectional structural view of A-A' of the present invention.
  • FIG. 4 is a schematic view showing the structure of the outer surface of the electrode of the present invention.
  • the present invention provides a multi-polar synchronous pulmonary artery radiofrequency ablation catheter for intra-pulmonary artery desympathetic nerve, wherein the catheter body has a distal end and a proximal end, and a distal end of the catheter body is provided with a flexible end, and the proximal end of the catheter body is provided a control handle, the pull wire extends in the conduit body; the conduit body is preferably made of a polymer material, and since the polymer material is a poor conductor of heat, the heat transfer during heating of the electrode can be better avoided The flow of blood in contact with the catheter body is more effective in avoiding heating of the blood.
  • the flexible end includes a proximal end and a distal end, the distal end of which is provided with an annular ring, the flexible end being flexible with respect to the rest of the catheter body; the annular ring is provided with a plurality of electrodes, each of which is capable of For extracting nerve electrical signals, temperature and ablation, each of which is connected with a wire and a temperature sensing wire, and extends through the catheter body to the control handle to be electrically connected to the control handle; each electrode Temperature sensing lines are implanted underneath, and the temperature sensing lines are used to accurately monitor the temperature during ablation.
  • a shape memory wire is disposed within the annular ring, the distal end of the shape memory wire extending to the distal end of the annular ring, the proximal end of which is secured to the distal end of the flexible end.
  • the metal material is preferably a shape memory alloy
  • the shape memory alloy is preferably a material such as nickel titanium alloy, stainless steel, or titanium.
  • the shape memory wire in the annular ring has a diameter of 0.25-0.5 mm and the annular ring has a diameter of 12-40 mm.
  • the flexible end has a length of 30-80 mm and is made of a medical polymer material, such as fluorine, polyester, polyurethane, polyamide, polyimide, and the like.
  • the distal end of the flexible end is provided with a counterbore, and the proximal end of the annular ring segment is fixed in the counterbore, wherein the proximal end of the annular ring segment is a ground end.
  • a traction wire is embedded in the catheter tube body, and one end of the traction wire is fixed on the control handle, and the curved shape of the flexible end can be controlled by operating the control handle.
  • the one end of the pull wire can be fixed to an adjustment knob on the control handle, and the bending of the flexible end can be controlled by operating the one adjustment knob. This allows the operator to control the handle with one hand and conveniently adjust the curvature of the flexible end so that the electrodes on the annular ring can be sufficiently adhered to the pulmonary artery to achieve ablation of the pulmonary artery wall.
  • the hole is drilled at the distal end of the flexible end 3, and the depth of the counterbore can be set according to actual needs, preferably 2-8 mm deep.
  • the proximal end of the annular ring 4 is a milled end whose outer diameter matches the inner diameter of the counterbore. Inserting the ground section into the flexible end 3, which may be fixed by bonding, welding or other suitable means, preferably by means of UV-curing glue to bond it to the distal end of the flexible end 3; and excess glue A seal can be made between the distal end of the flexible end 3 and the proximal end of the annular ring tube 4.
  • FIG 1 is a schematic view showing the structure of a multipolar synchronous pulmonary artery radiofrequency ablation catheter.
  • the annular ring 4 is provided at the distal end of the flexible end 3.
  • the annular ring 4 is a ring structure. Its curved shape may be constituted by the shape memory wire support.
  • a plurality of electrodes 5 are also provided on the annular ring 4. Each electrode can be used to extract neural electrical signals, sense temperature, and perform ablation.
  • the number of electrodes may be 3-30, and a more suitable number is 5-20.
  • the electrodes are made of a metal material such as platinum rhodium alloy, gold, stainless steel or nickel alloy.
  • the electrode diameter is generally 1.3 to 2.0 mm, the length of the electrode is generally 1.2 to 4 mm, and the more suitable length is 2 to 3.5 mm.
  • the edge spacing of adjacent electrodes is preferably from 0.5 to 10 mm, and more preferably from 1-5 mm.
  • the pull wire 8 preferably made of stainless steel or nitinol, as shown in Figures 2 and 3, has its distal end extending through the hollow cavity 9 to the proximal end of the annular ring 4 and to the distal end of the flexible end 3, which is fixed
  • the method can be any suitable method in the prior art.
  • a groove is provided at the distal end of the flexible end 3, and a connecting member 11 is disposed in the groove.
  • One end of the connecting member 11 is connected with the pulling wire 8, and the other end is connected with the shape memory wire 12, and passes through the groove.
  • a glue such as a UV curable glue, is inserted into the distal end of the flexible end 3.
  • a length of the traction wire 8 in the flexible end 3 extends inside the catheter body 1, preferably with a spring ring 13 on the outside and a spring sleeve 14 on the outside.
  • the spring sleeve 14 can be made of any suitable material, preferably a polyimide material.
  • the proximal end of the traction wire 8 is fixed on the control handle 2, and the control handle 2 is provided with an adjusting device, and the curved shape of the flexible end is adjusted by the adjusting device.
  • the wire 6, as shown in Figures 2 and 3, extends through the wire lumen 10 into the wire lumen of the annular ring 4, the distal ends of which are each connected to the electrode 5.
  • the distal end of the wire 6 is fixed to the electrode 5 by welding, and the distal end of the temperature sensing wire 7 is buried under the electrode 5, and the distal end of the temperature sensing wire 7 is fixed to the electrode 5 by bonding, welding or other suitable means. on.
  • the temperature sensing line 7 extends into the conduit body 1 in the wire cavity 10 in the flexible end 3 and finally extends through the control handle 2 to be connected to the temperature control device.
  • the traction wire 8 is manipulated by the control handle 2 such that the flexible end 3 is deflected, and the annular ring 4 is sent to the pulmonary artery port so that the electrode 5 can be sufficiently attached to the pulmonary artery. Wall, at which point the electrode 5 can be ablated on the inner wall of the pulmonary artery.
  • the multi-pole discharge pulmonary artery radiofrequency ablation catheter provided by the invention can improve the ablation effect and safety by multi-electrode design; and can realize the purpose of electrical signal analysis and preferably simultaneous ablation of multiple electrodes. Effectively improve the target accuracy of ablation, timely judgment of ablation effect and save operation time.
  • the multi-pole synchronous pulmonary artery ablation catheter comprises a control handle 2, a tube body 1 and an annular ring 4, and the control handle 2 is provided with an adjusting device; the tube body 1 is a hollow structure, and a cavity is arranged therein, and the cavity body is provided.
  • the wire 6, the temperature sensing wire 7 and the pulling wire 8, the one end of the pipe body has flexibility, the flexible end 3 is connected with the annular ring 4, the other end of the pipe body is connected with the control handle 2, and one end of the pulling wire 8 is connected with the flexible end 3.
  • the other end is connected with the adjusting device on the control handle, and the tensioning degree of the traction line is controlled by the adjusting device to realize the arc control of the flexible end; thus, the operator can control the handle with one hand, and conveniently adjust the curved shape of the flexible end.
  • the electrode on the annular ring can be sufficiently adhered to the pulmonary artery to achieve ablation of the inner wall of the pulmonary artery.
  • a shape memory wire 12 is disposed in the annular ring, one end of the shape memory wire extends to the distal end of the annular ring 4, and the other end is fixed to the flexible end 3 of the tubular body through the root of the annular ring, and the electrode ring is provided on the annular ring
  • Each electrode 5 is connected to a wire and a temperature sensing line 7, and both can be used to extract nerve electrical signals, sense temperature, and perform ablation.
  • the wire 6 and the temperature sensing wire 7 are electrically connected to the control handle 2 through the pipe body 1.
  • the control handle 2 can be externally connected to the temperature control device.
  • the electrode on the annular ring is made of platinum-rhodium alloy, gold, stainless steel or nickel alloy material, the number is 3-30, the electrode diameter is 1.3-2.0 mm, the length is 1.2-4 mm, and the edge spacing of adjacent electrodes is 0.5-10mm.
  • the flexible end of the tubular body defines a counterbore, and the outer diameter of the root of the annular ring cooperates with the inner diameter of the counterbore, and the root of the annular ring is inserted into the counterbore and fixed.
  • the flexible end 3 of the tubular body is provided with a groove, and a connecting member 11 is disposed in the groove.
  • One end of the connecting member is connected with the pulling wire 8 and the other end is connected with the shape memory wire 12.
  • the shape memory wire material in the annular ring is a shape memory alloy
  • the shape memory alloy is nickel titanium alloy, stainless steel or titanium
  • the diameter thereof is 0.25-0.5 mm
  • the annular ring diameter is 12-40 mm.
  • 10 electrodes are arranged on the annular ring, and the exposed portion of the electrode has a width of 0.75 mm and a pitch of 5 mm.
  • the flexible end of the tube body is made of medical polymer material and has a length of 30-80 mm, such as fluorine, polyester, polyurethane, polyamide, polyimide and the like.
  • connection is by a UV-curable adhesive.
  • the traction wire is made of stainless steel or nickel-titanium alloy, the outer part of the traction wire is sleeved with a spring ring 13, and the outer sleeve of the spring ring is sleeved with a spring sleeve 14, which is made of polyimide material.
  • the catheter tube body is provided with an infusion tube
  • the electrode is provided with a uniformly distributed set of through holes 15 having a diameter of 1 ⁇ m, and one end of the infusion tube is ring-shaped.
  • the inside of the ring is connected with the electrode, and the liquid is diffused and flows out through the through hole on the electrode, and the other end of the infusion tube is connected with the infusion system (optional advection pump).
  • the infusion system optionalal advection pump.
  • the infusion liquid can be physiological saline. Local cooling was achieved by cold physiological saline (4 ° C) perfusion.
  • the electrode generates a current, the physiological saline is uniformly diffused through the through hole uniformly, so that the local temperature is lower than 60 ° C, thereby protecting the intima of the blood vessel.

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Abstract

一种多极同步肺动脉射频消融导管，包括：控制手柄（2）、管身（1）和环形圈（4）。所述控制手柄（2）上设有调节装置。所述管身（1）为中空结构，其内设腔体（9，10），腔体（9，10）内设有导线（6）、温度感应线（7）和牵引线（8）。管身（1）的一端具有柔性，该柔性端（3）与环形圈（4）连接，管身（1）的另一端与控制手柄（2）连接。牵引线（8）的一端与柔性端（3）连接，另一端与控制手柄（2）上的调节装置连接。通过调节装置控制牵引线（8）的张紧程度，实现对柔性端（3）的弧度控制。环形圈（4）内设有形状记忆丝（12），该形状记忆丝（12）的一端延伸至环形圈（4）的末梢，另一端穿过环形圈（4）的根部固定于管身（1）的柔性端（3）。环形圈（4）上设有电极组，每个电极（5）均与导线（6）和温度感应线（7）连接，导线（6）和温度感应线（7）与控制手柄（2）电连接。在管身（1）腔体内设有输液管，通过灌注冷生理盐水，可以保护血管内膜。该导管具有操作简单，手术时间短，消融操作准确可控的优点。

Description

多极同步肺动脉射频消融导管 技术领域
本发明涉及一种用于肺动脉内去交感神经化治疗肺动脉高压的医疗器械，具体涉及一种多极同步肺动脉射频消融导管。
背景技术
肺动脉高压是心血管、呼吸、结缔组织、免疫风湿系统的疑难疾病，临床治疗手段有限、疗效极差。原发性肺动脉高压发病率低，但是继发于肺间质纤维化、结缔组织疾病、门静脉高压、慢性肺动脉栓塞及左心系统疾病的发病率较为常见，5年内的死亡率达到30%。因此，积极防治肺动脉高压具有十分重要的意义。
近年来依据对肺动脉高压发病机制的研究，新的靶向药物不断出现，但这些药物都存在着严重的局限性，包括副作用较多、剂型不合适、价格昂贵及疗效不可靠等，无法在临床治疗中得到广泛应用。实验数据证明肺动脉高压与肺动脉内交感神经兴奋性增高及压力感受器异常活跃有关，阻断肺动脉内交感神经或永久性破坏压力感受器的结构及其功能能够使肺动脉压下降，将成为治疗肺动脉高压的突破性技术。但该新兴技术还缺乏专业的手术器械，特别是专用的肺动脉射频消融导管来保障。
 技术问题
本发明提供一种多极同步肺动脉射频消融导管，用于肺动脉内去交感神经化治疗肺动脉高压，该导管仅对贴壁组织进行射频加热而不对血液进行加热，同时采用冷生理盐水灌注的方法，保护血管内膜，具有操作简单、手术时间短、消融准确可控等优点。
技术解决方案
多极同步肺动脉射频消融导管，包括控制手柄、管身和环形圈，所述控制手柄上设有调节装置；所述管身为中空结构，内设腔体，腔体内设有导线、温度感应线和牵引线，管身的一端具有柔性，该柔性端与环形圈连接，管身的另一端与控制手柄连接，牵引线的一端与柔性端连接，另一端与控制手柄上的调节装置连接，通过调节装置控制牵引线的张紧程度，实现对柔性端的弧度控制；所述环形圈内设有形状记忆丝，该形状记忆丝的一端延伸至环形圈的末梢，另一端穿过环形圈的根部固定于管身的柔性端，环形圈上设有电极组，每个电极均与导线和温度感应线连接，所述导线和温度感应线穿过管身与控制手柄电连接。
所述管身腔体内设有输液管，电极上设有通孔，所述输液管经环形圈内部与电极连接，所输液体经通孔流出。
所述环形圈上的电极采用铂铱合金、黄金、不锈钢或镍合金材料制成，数量为3-30个，电极直径为1.3～2.0mm，长度为1.2-4mm，相邻电极的边缘间距为0.5-10mm。
所述管身的柔性端开设沉孔，所述环形圈的根部外径与所述沉孔的内径相配合，将环形圈根部插入沉孔中并固定。
所述管身的柔性端设置凹槽，凹槽内设有连接件，所述连接件的一端与牵引线连接，另一端与形状记忆丝连接。
所述在所述环形圈内的形状记忆丝材料为形状记忆合金，所述形状记忆合金为镍钛合金、不锈钢或钛，其直径为0.25-0.5mm，所述的环形圈直径12-40mm。环形圈上优选设置10个电极，电极裸露部位宽度0.75mm，间距5mm。
所述管身柔性端采用医用高分子材料制成，长度为30-80mm。
所述连接方式为通过紫外线固化胶连接。
所述管身柔性端与环形圈之间的连接处密封。
所述牵引线由不锈钢或镍钛合金制成，牵引线外部套有弹簧圈，弹簧圈外部套有弹簧套管，弹簧套管由聚酰亚胺材料制成。
 有益效果
本发明由于采用了以上技术方案，使得该导管仅对贴壁组织进行射频加热而不对血液进行加热，具有操作简单、手术时间短、消融准确可控等优点。导管管身优选由高分子材料制成，由于高分子材料是热量的不良导体，从而能够更好地避免电极加热时的热量传递到与所述导管管身接触的流动血液，从而更有效地避免对血液的加热。此外，通过操作调节装置，能够控制所述柔性端的弯形。这样可以让手术者一只手控制手柄，方便地调整所述柔性端的弯形，使得所述环形圈上的电极可以与肺动脉充分贴壁，实现肺动脉内壁消融。电极产生射频电流的过程中，局部产生较高的温度，对血管内膜的损伤程度较重。为此，本发明还采用冷生理盐水灌注的方法，实现局部降温。当电极产生电流时，生理盐水自动通过通孔均匀地扩散出来，使得局部温度低于60℃，从而保护血管内膜。
 附图说明
图1为本发明的结构示意图；
图2为本发明B部的局部放大图；
图3为本发明A-A’的剖视结构示意图；
图4为本发明电极外表面结构示意图。
图中：1-管身；2-控制手柄；3-柔性端；4-环形圈；5-电极；6-导线；7-温度感应线；8-牵引线；9-空心腔；10-导线腔；11-连接件；12-形状记忆丝；13-弹簧圈；14-弹簧套管；15-通孔。
 本发明的实施方式
以下实施例进一步说明本发明的内容，但不应理解为对本发明的限制。在不背离本发明精神和实质的情况下，对本发明方法、步骤或条件所作的修改和替换，均属于本发明的范围。
若未特别指明，实施例中所用的技术手段为本领域技术人员所熟知的常规手段。
实施例1：
下面通过实施列，并结合附图1～3，对本发明的技术方案作进一步详细的说明。
本发明提供一种用于肺动脉内去交感神经的多极同步肺动脉射频消融导管，其中所述导管管身具有远端和近端，导管管身远端设有柔性端，导管管身近端设有控制手柄，牵引线在所述导管管身内延伸；导管管身优选由高分子材料制成，由于高分子材料是热量的不良导体，从而能够更好地避免电极加热时的热量传递到与所述导管管身接触的流动血液，从而更有效地避免对血液的加热。柔性端包括近端和远端，其远端设有环形圈，所述柔性端相对于所述导管管身的其余部分而言具有柔性；环形圈上设有多个电极，每个电极均能够用于提取神经电信号、温度和消融，每个电极下均连有导线和温度感应线，并经过所述导管管身延伸到所述控制手柄，从而与所述控制手柄电连接；每个电极下均埋植有温度传感线，所述温度传感线用于对消融过程中的温度进行精确监控。环形圈内设有形状记忆丝，所述形状记忆丝的远端延伸至所述环形圈的远端，其近端固定于所述柔性端的远端。在所述环形圈的形状记忆丝，所述金属材料优选为形状记忆合金，所述形状记忆合金优选为：镍钛合金、不锈钢、钛等材料。在所述环形圈中的形状记忆丝，其直径0.25-0.5mm，所述的环形圈直径12-40mm。所述柔性端的长度30-80mm，采用医用高分子材料制作，例如：氟类、聚酯类、聚氨酯、聚酰胺、聚酰亚胺等材料。所述柔性端的远端设有沉孔，所述环形圈段的近端固定于所述沉孔内，其中，环形圈段的近端为磨细端。所述导管管身内埋置牵引线，所述牵引线的一端固定在所述控制手柄上，通过操作所述控制手柄，能够控制所述柔性端的弯形。例如，可以将所述牵引线的所述一端固定在所述控制手柄上的一个调节钮上，通过操作所述一个调节钮，能够控制所述柔性端的弯形。这样可以让手术者一只手控制手柄，方便地调整所述柔性端的弯形，使得所述环形圈上的电极可以与肺动脉充分贴壁，实现肺动脉内壁消融。
进一步说，在柔性端3的远端打沉孔，所述沉孔的深度可以根据实际需要进行设定，优选为2-8mm深。所述环形圈4的近端为磨细端，其外径与所述沉孔的内径相配合。将所述磨细段插入柔性端3中，其可以通过粘结、焊接或其它合适的方式进行固定，优选的，通过紫外线固化胶将其与柔性端3远端粘结固定；并且多余的胶可以将所述柔性端3的远端与所述环形圈管4的近端之间进行密封。
图1所示的是多极同步肺动脉射频消融导管的结构示意图。所述环形圈4设于所述柔性端3的远端。所述环形圈4为环状结构。其弯形可由所述形状记忆丝支撑构成。在所述环形圈4上还设有多个电极5。每个电极均能够用于提取神经电信号、感知温度和实行消融。电极数量可以是3-30个，更适宜的数量为5-20个。电极采用铂铱合金、黄金、不锈钢或镍合金等金属材料制成。电极直径一般在1.3～2.0mm，电极的长度一般在1.2-4mm，更适宜的长度为2-3.5mm。相邻电极的边缘间距以0.5-10mm为宜，更适宜的间距为1-5mm。
牵引线8，优选由不锈钢或镍钛合金制成，如图2和图3所示，其远端通过空心腔9延伸至环形圈4近端，并固定到柔性端3远端上，其固定方式可以采用现有技术中任何合适的方法。优选的，在柔性端3的远端设置凹槽，凹槽内设有连接件11，所述连接件11的一端与牵引线8连接，另一端与形状记忆丝12连接，并通过向凹槽内注入胶水，如紫外固化胶将连接件固定于所述柔性端3的远端。在柔性端3内延伸一段牵引线8，在所述导管管身1内延伸一段牵引线8，优选的，其外部套有弹簧圈13，其外部套有弹簧套管14。所述弹簧套管14可由任何合适的材料制成，优选由聚酰亚胺材料制成。
牵引线8近端固定在控制手柄2上，控制手柄2上设有调节装置，通过调节装置调整柔性端的弯形。
导线6，如图2、3所示，通过导线腔10延伸至环形圈4的导线腔内，所述导线6的远端分别与电极5连接。导线6远端通过焊接固定在电极5上，温度感应线7远端埋藏于电极5下，所述温度感应线7的远端通过粘结、焊接或其它合适的方式固定在所述的电极5上。温度感应线7在柔性端3内的导线腔10中延伸至导管管身1内，最后通过所述控制手柄2延伸出来，与温控装置连接。
所述导管在使用过程中，通过控制手柄2，操纵所述牵引线8，使得所述柔性端3发生偏转，将所述环形圈4送至肺动脉口，使得所述电极5可以与肺动脉充分贴壁，此时所述电极5可以在肺动脉内壁上进行消融。
本发明提供的多极放电肺动脉射频消融导管，多电极设计可以提高消融效果和安全性；可以实现电信号分析和优选地进行多个电极同时消融的目的。有效提高消融的目标准确性、消融效果的及时判断性并节约手术时间。
实施例2
多极同步肺动脉射频消融导管，包括控制手柄2、管身1和环形圈4，所述控制手柄2上设有调节装置；所述管身1为中空结构，内设腔体，腔体内设有导线6、温度感应线7和牵引线8，管身的一端具有柔性，该柔性端3与环形圈4连接，管身的另一端与控制手柄2连接，牵引线8的一端与柔性端3连接，另一端与控制手柄上的调节装置连接，通过调节装置控制牵引线的张紧程度，实现对柔性端的弧度控制；这样可以让手术者一只手控制手柄，方便地调整所述柔性端的弯形，使得所述环形圈上的电极可以与肺动脉充分贴壁，实现肺动脉内壁消融。所述环形圈内设有形状记忆丝12，该形状记忆丝的一端延伸至环形圈4的末梢，另一端穿过环形圈的根部固定于管身的柔性端3，环形圈上设有电极组，每个电极5均与导线和温度感应线7连接，且均能够用于提取神经电信号、感知温度和实行消融。所述导线6和温度感应线7穿过管身1与控制手柄2电连接。控制手柄2可外接温控装置。
所述环形圈上的电极采用铂铱合金、黄金、不锈钢或镍合金材料制成，数量为3-30个，电极直径为1.3～2.0mm，长度为1.2-4mm，相邻电极的边缘间距为0.5-10mm。
所述管身的柔性端开设沉孔，所述环形圈的根部外径与所述沉孔的内径相配合，将环形圈根部插入沉孔中并固定。
所述管身的柔性端3设置凹槽，凹槽内设有连接件11，所述连接件的一端与牵引线8连接，另一端与形状记忆丝12连接。
所述在所述环形圈内的形状记忆丝材料为形状记忆合金，所述形状记忆合金为镍钛合金、不锈钢或钛，其直径为0.25-0.5mm，所述的环形圈直径12-40mm。环形圈上优选设置10个电极，电极裸露部位宽度0.75mm，间距5mm。
所述管身柔性端采用医用高分子材料制成，长度为30-80mm，例如：氟类、聚酯类、聚氨酯、聚酰胺、聚酰亚胺等材料。
所述连接方式为通过紫外线固化胶连接。
所述管身柔性端与环形圈之间的连接处密封。
所述牵引线由不锈钢或镍钛合金制成，牵引线外部套有弹簧圈13，弹簧圈外部套有弹簧套管14，弹簧套管由聚酰亚胺材料制成。
实施例3
与实施例1和实施例2的主体结构类似，区别在于，所述导管管身内设有输液管，电极上设有均匀分布的一组通孔15，孔径为1μm，所述输液管一端经环形圈内部与电极连接，所输液体经电极上的通孔扩散流出，输液管另一端与输液系统（可选用平流泵）连接，当电极产生电流时，液体自动通过通孔均匀地扩散出来，所输液体可以是生理盐水。采用冷生理盐水（4℃）灌注的方法，实现局部降温。当电极产生电流时，生理盐水自动通过通孔均匀地扩散出来，使得局部温度低于60℃，从而保护血管内膜。

Claims (10)

  1. 多极同步肺动脉射频消融导管，其特征在于包括控制手柄（2）、管身（1）和环形圈（4），所述控制手柄（2）上设有调节装置；所述管身（1）为中空结构，内设腔体，腔体内设有导线（6）、温度感应线（7）和牵引线（8），管身的一端具有柔性，该柔性端（3）与环形圈（4）连接，管身的另一端与控制手柄（2）连接，牵引线（8）的一端与柔性端（3）连接，另一端与控制手柄上的调节装置连接，通过调节装置控制牵引线的张紧程度，实现对柔性端的弧度控制；所述环形圈内设有形状记忆丝（12），该形状记忆丝的一端延伸至环形圈（4）的末梢，另一端穿过环形圈的根部固定于管身的柔性端（3），环形圈上设有电极组，每个电极（5）均与导线和温度感应线（7）连接，所述导线（6）和温度感应线（7）穿过管身（1）与控制手柄（2）电连接。
  2. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述管身腔体内设有输液管，电极上设有通孔（15），所述输液管经环形圈内部与电极连接，所输液体经通孔流出。
  3. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述环形圈上的电极采用铂铱合金、黄金、不锈钢或镍合金材料制成，数量为3-30个，电极直径为1.3～2.0mm，长度为1.2-4mm，相邻电极的边缘间距为0.5-10mm。
  4. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述管身的柔性端开设沉孔，所述环形圈的根部外径与所述沉孔的内径相配合，将环形圈根部插入沉孔中并固定。
  5. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述管身的柔性端（3）设置凹槽，凹槽内设有连接件（11），所述连接件的一端与牵引线（8）连接，另一端与形状记忆丝（12）连接。
  6. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述环形圈内的形状记忆丝材料为形状记忆合金，所述形状记忆合金为镍钛合金、不锈钢或钛，其直径为0.25-0.5mm，所述的环形圈直径12-40mm。
  7. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述管身柔性端采用医用高分子材料制成，长度为30-80mm。
  8. 根据权利要求1~7任一所述的多极同步肺动脉射频消融导管，其特征在于所述连接方式为通过紫外线固化胶连接。
  9. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述管身柔性端与环形圈之间的连接处密封。
  10. 根据权利要求1所述的多极同步肺动脉射频消融导管，其特征在于所述牵引线由不锈钢或镍钛合金制成，牵引线外部套有弹簧圈（13），弹簧圈外部套有弹簧套管（14），弹簧套管由聚酰亚胺材料制成。
PCT/CN2013/073338 2012-11-13 2013-03-28 多极同步肺动脉射频消融导管 Ceased WO2014075415A1 (zh)

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BR112014007594-8A BR112014007594B1 (pt) 2012-11-13 2013-03-28 Cateter síngrono multipolar para ablação por radiofrequência da artéria pulmonar
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RU2014112769A (ru) 2016-02-27
US20150057599A1 (en) 2015-02-26
EP2910213A1 (en) 2015-08-26
KR20140088087A (ko) 2014-07-09
EP2910213B1 (en) 2019-03-20
RU2587945C9 (ru) 2016-09-27
CN103142304A (zh) 2013-06-12
US20140180277A1 (en) 2014-06-26
CN103142304B (zh) 2015-12-02
JP6054415B2 (ja) 2016-12-27
US20160338774A1 (en) 2016-11-24
BR112014007594B1 (pt) 2022-03-22
CN102908191A (zh) 2013-02-06
KR101640329B1 (ko) 2016-07-15
JP2015502823A (ja) 2015-01-29
RU2587945C2 (ru) 2016-06-27
BR112014007594A2 (pt) 2017-04-25
EP2910213A4 (en) 2015-12-16

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