WO2016019760A1 - Cathéter d'ablation par radiofréquence ayant une structure de stent en forme de pétale et appareil associé - Google Patents

Cathéter d'ablation par radiofréquence ayant une structure de stent en forme de pétale et appareil associé Download PDF

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Publication number
WO2016019760A1
WO2016019760A1 PCT/CN2015/081583 CN2015081583W WO2016019760A1 WO 2016019760 A1 WO2016019760 A1 WO 2016019760A1 CN 2015081583 W CN2015081583 W CN 2015081583W WO 2016019760 A1 WO2016019760 A1 WO 2016019760A1
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Prior art keywords
stent
petal
wire
ablation catheter
radiofrequency ablation
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PCT/CN2015/081583
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English (en)
Chinese (zh)
Inventor
董永华
沈美君
吉亮
施政民
Original Assignee
上海魅丽纬叶医疗科技有限公司
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Priority to CN201590000029.8U priority Critical patent/CN205913392U/zh
Publication of WO2016019760A1 publication Critical patent/WO2016019760A1/fr

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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
    • 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

Definitions

  • the present invention relates to a radio frequency ablation catheter, and more particularly to a radio frequency ablation catheter having a lobed stent structure, and to a radio frequency ablation device including the radiofrequency ablation catheter described above, which belongs to the technical field of medical instruments.
  • radio frequency electrodes are key devices for contacting or approaching the body tissue being treated and for RF energy release.
  • the RF electrode is used to convert the RF signal into a temperature field and treat the human tissue through thermal effects. Whether the RF electrode is attached to the wall during the operation has a decisive effect on the therapeutic effect of radiofrequency ablation.
  • the radio frequency electrode is mounted on a bracket at the front end of the radiofrequency ablation catheter.
  • the stent is used to carry the radio frequency electrode, and the extension is attached before the radio frequency starts, and the radiofrequency is contracted and then withdrawn. Since the radiofrequency ablation procedure is performed directly in the blood vessels of the human body, the telescopic size of the stent is adapted to the diameter of the human blood vessel.
  • the diameter of the blood vessels in the human body varies with the location of the ablation. At the same time, the diameter of the blood vessels of the human body varies from person to person. The diameter of the blood vessels of the human body is about 2 to 10 mm, which is quite different.
  • the telescopic size of the electrode end of the radiofrequency ablation catheter is generally limited, and it is not suitable for the diameter of different human blood vessels, and the coverage of human blood vessels of different diameters is narrow. Therefore, when performing radiofrequency ablation procedures on different patients, it is usually necessary to replace the radiofrequency ablation catheters of different specifications and models for ablation. Even so, in some cases, there is a problem that the RF electrode cannot be attached at the same time during surgery, which affects the surgical effect.
  • the existing radiofrequency ablation catheter can be modified so that the stent with the RF electrode has a good expansion ratio, thereby enhancing its adaptability to the diameter of the blood vessel, it can cover the blood vessels of different diameters during the operation, and improve Coverage of the device.
  • the existing radiofrequency ablation catheters generally have poor adaptability to curved blood vessels, and most of the radiofrequency ablation catheters are unable to adhere to the electrodes in the curved blood vessels. Therefore, if the new radiofrequency ablation catheter can simultaneously improve the coverage of the curved blood vessels, it will greatly expand the application range of radiofrequency ablation, and at the same time improve the radiofrequency ablation effect, which has a positive effect on the promotion of radiofrequency ablation.
  • the primary technical problem to be solved by the present invention is to provide a radio frequency ablation catheter having a lobed stent structure.
  • the radiofrequency ablation catheter has good adaptability to different diameter blood vessels and curved blood vessels, and has wide coverage.
  • Another technical problem to be solved by the present invention is to provide a radio frequency ablation device including the above radio frequency ablation catheter.
  • a radiofrequency ablation catheter having a valvular stent structure comprising a valvular stent processed from the same hollow tubular material, the valvular stent comprising a plurality of stent wires distributed circularly about a central axis, and the stent wire One or two connecting tubes; wherein the length of each of the stent wires extends along the length of the hollow tube, and the two ends of the stent wire are respectively gathered to form the distal end and the proximal end of the petal stent One or more electrodes are respectively disposed in the middle portion of each of the stent wires, and the intermediate portion of the petal stent has a contracted state and an expanded state.
  • the middle portion of the pipe forms a plurality of separate support wires, and the two ends of the pipe respectively form two connecting pipes integral with the support wire; or, the middle portion of the pipe forms a separated plurality of wires A stent wire, one end of which forms a connecting tube integral with the stent wire, the other end of the tube forming a separate end of the stent wire.
  • the lobed stent further comprises a central wire drawing disposed at a central axis position, and one end of the center wire is fixed to the distal end of the valvular stent or penetrates the distal end of the valvular stent and is Restricted to the outside of the petal stent, the other end passes through the center of the petal stent and exits from the proximal end, and the central wire can axially pull the petal stent relative to the proximal end, so that It expands outwardly and the central wire can slide towards the distal end of the petal stent relative to the petal stent.
  • the stent wire of the petal stent is shaped into a middle cylinder and a cylindrical shape with both ends contracted; or the stent wire of the petal stent is shaped into a circular drum with a middle protrusion and a natural contraction at both ends. shape.
  • the electrode is provided with an opening on the circumference thereof.
  • the axial projection of the plurality of electrodes does not overlap in the axial direction of the lobed stent.
  • a plurality of the electrodes are on the circumferential surface of the lobed stent A straight line or staggered into a plurality of straight lines.
  • the lobed stent is provided with an anti-floating structure
  • the anti-floating structure is an anti-floating rib fixed on the plurality of stent wires.
  • the proximal end of the petal stent is connected with a porous tube, and one end of the central wire is fixed at the distal end of the petal stent or is limited to the outer side of the distal end of the petal stent and can be opposite to
  • the distal end of the petal stent is free to slide, and the other end passes through a central hole of the porous tube;
  • the electrode penetrates the stent wire, the thermocouple wire and the radio frequency wire, and the two ends of the electrode are respectively fixed at the On the valvular stent, one end of the thermocouple wire and the radio frequency wire is fixed in the electrode, and the other end is connected to an external device through a corresponding hole on the porous tube.
  • the radio frequency wire and the thermocouple wire are made into the same wire.
  • a radio frequency ablation device includes the above-described radio frequency ablation catheter, a control handle connected to the radio frequency ablation catheter, and a radio frequency ablation host.
  • the radiofrequency ablation catheter provided by the invention adopts a valvular stent processed from the same tube.
  • the valvular stent has good flexibility, and the arrangement of the electrodes can meet specific requirements after the expansion of the adherence, so that when the valvular stent is automatically expanded and pulled in blood vessels of different diameters, all the electrodes can be fully
  • the wall is attached and the plurality of electrodes do not overlap in the axial direction and do not cause excessive ablation.
  • the valvular stent has good flexibility, and has wide coverage of blood vessels of different diameters, and can at least meet the radiofrequency ablation requirements of blood vessels of 4 to 12 mm.
  • the above-mentioned valvular stent also has good coverage for curved blood vessels.
  • FIG. 1 is a schematic structural view of a petal stent provided by the present invention.
  • FIG. 2 is a schematic view showing a first arrangement of a plurality of electrodes in a valvular stent provided by the present invention
  • FIG. 3 is a schematic view showing a second arrangement of a plurality of electrodes in a valvular stent provided by the present invention
  • FIG. 4 is a schematic view showing a third arrangement of a plurality of electrodes in a valvular stent provided by the present invention.
  • FIG. 5 is a schematic structural view showing a plurality of electrodes disposed on the same stent wire in the lobed stent provided by the present invention
  • Figure 6 is a schematic view showing the first anti-falling structure of the petal stent provided by the present invention.
  • Figure 7 is a schematic view showing a second anti-falling structure in the petal stent provided by the present invention.
  • Figure 8 is a schematic view showing three structures of electrodes in the valve-shaped stent provided by the present invention.
  • Figure 9 is a schematic view showing the action of electrodes adhering to the valvular stent when the blood vessel is thin;
  • Fig. 10 is a schematic view showing the operation of the electrode in the petal stent when the blood vessel is thick.
  • the end near the operator is referred to as the proximal end
  • the end remote from the operator is referred to as the distal end.
  • the radiofrequency ablation catheter provided by the present invention comprises a petal stent 1 processed from the same hollow tubing, and the petal stent 1 expands in a blood vessel and has a shape similar to a lantern skeleton.
  • the petal stent 1 comprises a plurality of stent wires 2 distributed in a circular shape about a central axis, and one or two connecting tubes integral with the stent wires 2.
  • each of the stent wires 2 extends along the longitudinal direction of the hollow tubing, and both ends of all the stent wires 2 are respectively gathered to constitute the distal end and the proximal end of the petal stent 1,
  • One or more electrodes 4 are respectively disposed in the middle section of each of the stent wires 2 (see FIGS. 1 and 5).
  • the middle section of the valvular stent has two kinds of contracted state and expanded state, and the middle section of the stent wire 2 is
  • the ablation site can be expanded in the lumen of the ablation site.
  • the middle portion of the petal stent 1 When the petal stent 1 is expanded in the blood vessel, the middle portion of the petal stent 1 forms a horizontal section having a certain length (see the B region of FIG. 1) under the action of the blood vessel wall, and is disposed in the middle of the stent wire 2.
  • the electrode 4 on the segment is in good adhesion to the vessel wall.
  • one or more electrodes may be disposed on each stent wire.
  • the arrangement of the plurality of electrodes does not need to have a special shape, in order to ensure that the plurality of electrodes do not cause excessive ablation of the blood vessel wall, preferably, the arrangement pattern of the plurality of electrodes can be made.
  • the projection in the axial direction of the petal stent satisfies the requirement of no overlap.
  • FIG. 2 Two arrangement shapes of six electrodes on the circumferential surface development view of the lobed stent 1 are shown in Figs. 2 to 4, and in the embodiment shown in Figs. 2 to 4, each of the lobed stents 1 An electrode is fixed to the root stent wire.
  • the six stent wires 2 are sequentially labeled as #1 filament to #6 filament from top to bottom.
  • six electrodes are sequentially arranged from the upper left to the lower right in the B region on each of the stent wires, arranged in a straight line; in the two embodiments shown in FIGS. 3 and 4.
  • the six electrodes are staggered from the upper left to the lower right and arranged in two straight lines.
  • the six electrodes are arranged in a spiral shape on the outer circumferential surface of the petal stent, but this does not mean that a plurality of electrodes need to be regularly arranged on the outer circumferential surface of the petal stent, in other In an embodiment in which a specific structural diagram is given, the plurality of electrodes may also be randomly arranged on the developed view of the lobed support or arranged in other shapes. In the actual ablation procedure, it is only necessary to ablate the nearby nerve tissue according to the position of the individual electrodes.
  • two electrodes are fixed to each stent wire.
  • more than two electrodes may be disposed on each of the stent wires.
  • the plurality of electrodes are easily overlapped in the axial direction of the valvular stent (as shown in FIG. 5), and there may be a certain risk relative to a simple spiral setting or a uniform arrangement.
  • this does not mean that a plurality of electrodes cannot overlap on the projection and axial projection of the circumferential surface of the lobes.
  • the main emphasis is on the integrated structure of the stent wire and the connecting tube disposed at one end or one end thereof, and the number and arrangement of the electrodes fixed on the stent wire. There are no special requirements.
  • the two ends of the lobed stent 1 provided by the present invention may be completely closed, or may be closed at one end and open at one end.
  • the specific structure may be referred to FIG. 6 and FIG.
  • both ends of the lobed stent 1 are closed.
  • the middle portion of the pipe is processed to form a plurality of separate support wires 2, and the two ends of the pipe are not processed to form two connecting pipes 11 integral with the support wire 2.
  • one end of the lobed stent 1 is closed and the other end is open.
  • the middle portion of the tube is processed to form a plurality of separate stent wires 2, one end of which forms a connecting tube 13a integral with the stent wire 2, and the other end of the tube is processed to form separate ends 13b of the stent wire 2.
  • the ends of the stent wires 2 are gathered but not connected to each other, and it is convenient to penetrate and set the electrodes.
  • One end of the opening of the petal stent 1 can be used as a distal end or as a proximal end.
  • a connector is usually provided at one end of the opening of the petal stent 1 to be closed and then combined with other components (for example, the porous tube 7). ) to assemble.
  • the above-mentioned lobed stent 1 is processed from the same hollow tubular material, and of course, it can be processed by other profiles or bars to obtain a hollow tubular material.
  • the circular tube having the memory function can be processed by an engraving process, and then expanded and shaped to form a separate stent wire 2 in the middle of the tube, and a connecting tube integrally formed therewith at one or both ends of the stent wire 2.
  • the plurality of stent wires 2 have good mechanical properties and prevent their lodging deformation; and the stent wire 2 has good stretchability.
  • the adherence can be expanded in blood vessels of different diameters.
  • the petal stent 1 can be processed using a material such as a titanium alloy or a memory alloy, and the petal stent 1 can also be processed from a polymer material.
  • the stent wire 2 may be shaped after being formed, or may be directly assembled after being used for the styling process.
  • the stent wire 2 When the stent wire 2 is shaped, it can be shaped into a cylindrical shape with a cylindrical shape at both ends; it can also be shaped into a circular drum shape with a middle protrusion and a natural contraction at both ends.
  • the stent wire when it is expanded in the blood vessel, the stent wire can be deformed into a shape as shown in Fig. 1 under the action of the blood vessel wall, thereby ensuring that it is disposed on the middle portion of the stent wire.
  • the electrodes are well attached.
  • the present invention is further provided with an anti-floating structure on the petal stent 1, and the anti-falling structure has various kinds, specifically, the anti-floating structure is fixed on the plurality of stent wires 2.
  • the ribs are connected to each other by using the anti-overflow ribs.
  • a plurality of anti-floating ribs may be disposed on one of the lobes 1 .
  • the anti-floating structure may be an oblique anti-overturning rib 12 fixed on the plurality of support wires 2 as shown in FIG.
  • the anti-floating ribs enhance the structural strength of the lobed support to a certain extent, the length and inclination setting may also restrict the external expansion performance of the lobed support to a certain extent, that is, limit The maximum diameter of the blood vessel that can be accommodated by the valvular stent. Therefore, when designing the anti-floating rib, it is necessary to combine the covered blood vessel range and reasonably design the length and inclination of the anti-floating rib.
  • the present invention provides several electrodes 4 of different shapes.
  • the center of the electrode 4 may have a circular hole, and the electrode 4 may have an opening on the circumference thereof.
  • the center holes of the two electrodes on the left side are larger, and it is easier to fix the thermocouple wire 5 and the RF wire 6 inside the assembly while the center of the right electrode is assembled. There is no round hole, and its internal space is small, making it difficult to assemble.
  • the left electrode there is no opening on the circumference of the left electrode, which is only suitable for the assembly of the petal-shaped bracket 1 which is closed at one end and open at one end, and is not suitable for the petal-shaped bracket 1 which is closed at both ends and integrally formed; Since the electrodes are provided with openings on the circumference, it is more suitable for the assembly of the petal-shaped brackets 1 which are closed at both ends, and can also be used for the petal-shaped stents 1 which are closed at one end and open at one end.
  • thermocouple wire and the RF wire provided inside can be made to be fixed by the same wire.
  • a central wire drawing 3 is also provided at the central axis position of the petal stent 1.
  • one end of the center wire 3 is fixed in a connecting tube disposed at the distal end of the petal holder 1, and the other end is passed through the inside of the petal holder 1 from the proximal end of the petal holder 1, and the center is drawn.
  • the central opening through the perforated tube 7 connected to the proximal end of the petal stent 1 extends to a control handle disposed at the end of the catheter.
  • the central wire drawing 3 can axially pull the petal-shaped stent 1 relative to the proximal end of the petal stent 1 and the porous tube 7 under external force to expand the petal stent.
  • the central wire drawing 3 can automatically slide; when the center wire drawing 3 is pulled backward from the outside, the petal stent 1 will further develop.
  • the diameter thereof becomes large, so that a plurality of electrodes can be attached in a blood vessel having a relatively large diameter.
  • the petal stent 1 when the center wire 3 is pushed forward from the outside using an external force, the petal stent 1 can be contracted so that the position of the petal stent 1 can be moved within the blood vessel or the petal stent 1 can be withdrawn from the blood vessel. During the movement, damage to the vessel wall by the valve holder 1 can be avoided.
  • the distal end of the central wire drawing may not be fixed to the connecting tube integrally formed with the valvular stent, but may be passed through the connecting tube at the distal end of the valvular stent and the head end of the radiofrequency ablation catheter. Secured together such that the distal end of the central wire is restrained to the outside of the distal end of the petal stent; the proximal end of the central wire is passed through the interior of the petal stent and exits the center of the proximal end of the petal stent.
  • the center wire can axially pull the valvular stent relative to the connecting tube to expand outwardly, and at the same time, the central wire can also be distal to the valvular stent relative to the connecting tube and the valvular stent. Free slip.
  • the center wire drawing 3 is pulled outward by applying a pulling force F2, the length of the valve stent 1 is reduced, and the stent wire 2 is bulged outwardly, and is in an expanded state; During the process, the electrode 4 moves toward the blood vessel wall and gradually adheres to the wall, which is in good contact with the blood vessel wall.
  • the valvular stent used in the radiofrequency ablation catheter provided by the present invention can be used not only for the stent which has been shaped before the assembly, but also for the stent which has not been shaped before the assembly.
  • the valvular stent cannot be naturally expanded. At this time, by pulling the central wire drawing, it is also possible to ensure the plurality of electrodes disposed on the intermediate segment at the same time.
  • the wall is attached, and after the valvular stent is expanded, the axial projections of the plurality of electrodes do not overlap in the axial direction of the lobed stent, and the circumferential projections of the plurality of electrodes are evenly distributed on the circumferential section of the lobed stent.
  • a porous tube 7 is further included, and the porous tube 7 is connected to the proximal end of the lobed stent; and one end of the central drawing 3 disposed inside the valvular stent is fixed. At the distal end of the petal stent, the other end passes through the proximal end of the petal stent and the central bore of the perforated tube 7, extending outside the catheter and connected to the control handle.
  • thermocouple wire 5 and an RF wire 6 are bored in each of the electrodes 4, and two ends of the electrode 4 are respectively fixed on the wire 2, and one end of the thermocouple wire 5 and the RF wire 6 is fixed in the electrode 4. The other end is connected to the external device through a corresponding hole in the porous tube 7. Since the valvular stent has good coverage of blood vessels of different diameters, the same radiofrequency ablation catheter including the above lobular stent can be used for radiofrequency ablation of different patients, and the device coverage is good.
  • a central puncture needle is further disposed.
  • the central puncture needle protrudes from the surface of the stent into the vascular wall when the valvular stent is expanded and attached, and performs puncture injection; when the valvular stent contracts, the center The puncture needle contracts into the interior of the petal stent.
  • the valvular stent provided by the invention has good adaptability to the curved blood vessel.
  • the whole can be bent to adapt to the shape of the blood vessel, and is disposed on the middle portion thereof.
  • Multiple electrodes can be attached to the wall at the same time.
  • the radiofrequency ablation catheter and the radiofrequency ablation device provided by the invention can be applied to nerve ablation of different parts, blood vessels or trachea of different diameters.
  • it is applied to renal artery ablation for the treatment of patients with refractory hypertension.
  • It is used in the treatment of diabetic patients with intra-abdominal artery ablation.
  • it is applied to the treatment of asthma patients with tracheal/bronchial vagal branch ablation, and for duodenal vagus nerve.
  • the radiofrequency ablation catheter provided by the present invention is not limited to the above enumerated applications in clinical treatment, and can also be used for nerve ablation in other parts.
  • the radiofrequency ablation catheter provided by the present invention has been described above, and the present invention also provides a radiofrequency ablation device including the radiofrequency ablation catheter described above.
  • the radiofrequency ablation device includes a control handle and a radio frequency ablation host connected to the radio frequency ablation catheter, in addition to the radio frequency ablation catheter.
  • the central wire in the valvular stent is connected to the control handle through the porous tube, and the advancement, retreat and bending of the radiofrequency ablation catheter can be controlled by the control handle.
  • the RF wires and thermocouple wires in the lobed stent are respectively connected to corresponding circuits in the radio frequency ablation host through the porous tube, thereby realizing radio frequency control and temperature monitoring of the plurality of electrodes by the radio frequency ablation host. Since the setting of the control handle and the setting of the radio frequency ablation host can be referred to the patents previously filed and disclosed by the present applicant, the detailed structure will not be described in detail herein.
  • the radiofrequency ablation catheter provided by the present invention is processed by a tube material because of the lobed stent used, which has the flexibility to ensure the strength, so that it is not easy to fall, and the stent wire is arranged on the wire.
  • the arrangement of the electrodes satisfies the specific requirements when expanding the adherence, so that when the petal stent expands in the blood vessels of different diameters, the plurality of electrodes can all be attached, and the plurality of electrodes are in the axial direction of the petal stent. Do not overlap.
  • the valvular stent has good flexibility, and has wide coverage of blood vessels of different diameters, and can at least meet the radiofrequency ablation requirements of blood vessels of 4 to 12 mm.
  • the petal stent also has good coverage for the curved blood vessel at the same time. Therefore, the radiofrequency ablation catheter provided by the present invention and the radiofrequency ablation device including the radiofrequency ablation catheter described above have extensive coverage for radiofrequency surgery of different patients.
  • radio frequency ablation catheter and the device thereof having the lobed stent structure provided by the present invention are described in detail above. Any obvious changes made to the present invention without departing from the spirit of the invention will constitute an infringement of the patent right of the present invention and will bear corresponding legal liabilities.

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Abstract

La présente invention concerne un cathéter d'ablation par radiofréquence ayant une structure de stent en forme de pétale, comprenant un stent en forme de pétale (1) produit à partir d'un même tube creux. Le stent en forme de pétale (1) comprend, selon une distribution circulaire autour de l'axe central de celui-ci, de multiples fils d'endoprothèse (2) et un ou deux tubes de raccordement intégrés avec les fils de stent (2). Les directions longitudinales des fils de stent (2) s'étendent dans le sens de la longueur du tube creux. Les deux extrémités des fils de stent (2) se rassemblent pour constituer une extrémité distale et une extrémité proximale du stent en forme de pétale (1). Une ou plusieurs électrodes (4) sont prévues respectivement dans les sections intermédiaires des fils de stent (2). La section intermédiaire du stent en forme de pétale (1) a un état contracté et un état déployé. Le stent en forme de pétale (1) dans le cathéter d'ablation par radiofréquence est produit à partir d'un même tube, a une extensibilité améliorée, satisfait à une exigence spécifique avec la formation dans laquelle les multiples électrodes sont agencées lorsqu'il est déployé et fixé à une paroi, et permet une grande couverture des vaisseaux sanguins de différentes épaisseurs et des vaisseaux sanguins incurvés.
PCT/CN2015/081583 2014-08-05 2015-06-16 Cathéter d'ablation par radiofréquence ayant une structure de stent en forme de pétale et appareil associé WO2016019760A1 (fr)

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Application Number Priority Date Filing Date Title
CN201590000029.8U CN205913392U (zh) 2014-08-05 2015-06-16 具有瓣状支架结构的射频消融导管及其设备

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CN201410381420.9 2014-08-05
CN201410381420 2014-08-05
CN201410554495.2A CN104257427A (zh) 2014-08-05 2014-10-17 具有瓣状支架结构的射频消融导管及其设备
CN201410554495.2 2014-10-17

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