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WO2016019760A1 - Radiofrequency ablation catheter having petal-shaped stent structure and apparatus thereof - Google Patents

Radiofrequency ablation catheter having petal-shaped stent structure and apparatus thereof 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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WIPO (PCT)
Prior art keywords
stent
petal
wire
ablation catheter
radiofrequency ablation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2015/081583
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French (fr)
Chinese (zh)
Inventor
董永华
沈美君
吉亮
施政民
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANGHAI GOLDEN LEAF MED TEC Co Ltd
Original Assignee
SHANGHAI GOLDEN LEAF MED TEC Co Ltd
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Application filed by SHANGHAI GOLDEN LEAF MED TEC Co Ltd filed Critical SHANGHAI GOLDEN LEAF MED TEC Co Ltd
Priority to CN201590000029.8U priority Critical patent/CN205913392U/en
Publication of WO2016019760A1 publication Critical patent/WO2016019760A1/en
Anticipated expiration legal-status Critical
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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

A radiofrequency ablation catheter having a petal-shaped stunt structure, comprising a petal-shaped stent (1) processed from a same hollow tube. The petal-shaped stent (1) comprises in a circular distribution around the central axis thereof multiple stent wires (2) and either one or two connecting tubes integrated with the stent wires (2). The lengthwise directions of the stent wires (2) extend in the lengthwise direction of the hollow tube. Both extremities of the stent wires (2) congregate to constitute a distal extremity and a proximal extremity of the petal-shaped stent (1). One or multiple electrodes (4) are provided respectively in the middle sections of the stent wires (2). The middle section of the petal-shaped stent (1) has a contracted state and an expanded state. The petal-shaped stent (1) in the radiofrequency ablation catheter is processed from a same tube, has improved extensibility, satisfies a specific requirement with the formation in which the multiple electrodes are arranged when expanded and attached to a wall, and provides great coverage for blood vessels of different thicknesses and curved blood vessels.

Description

具有瓣状支架结构的射频消融导管及其设备Radiofrequency ablation catheter with lobed stent structure and device thereof 技术领域Technical field

本发明涉及一种射频消融导管,尤其涉及一种具有瓣状支架结构的射频消融导管,同时还涉及包含上述射频消融导管的射频消融设备,属于医疗器械技术领域。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.

背景技术Background technique

在射频消融系统中,射频电极是用于接触或靠近被治疗的人体组织并进行射频能量释放的关键器件。射频电极用于将射频信号转化成温度场,通过热效应对人体组织进行治疗。在手术过程中,射频电极是否贴壁对射频消融手术的治疗效果具有决定性的作用。In radiofrequency ablation systems, 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.

在射频消融导管中,射频电极安装在射频消融导管前端的支架上,支架用于承载射频电极,并在射频开始之前扩展贴壁,射频结束后收缩后撤。由于射频消融手术是直接介入人体血管中进行的,所以支架的伸缩尺寸要适合人体血管的直径。In the radiofrequency ablation catheter, 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.

人体内血管直径因为消融部位的不同而不同,同时人体血管的直径还因人而异,人体血管直径大约在2~10mm之间,差别较大。现有技术中,射频消融导管的电极端的伸缩尺寸普遍是一定的,无法适应不同人体血管的直径尺寸,对不同直径的人体血管的覆盖面窄。因此,在对不同的病人进行射频消融手术时,通常需要更换不同规格、型号的射频消融导管进行消融。即便如此,在有些情况下,还会出现手术时,射频电极无法同时贴壁的问题,影响手术效果。因此,如果可以对现有的射频消融导管进行改进,使其安装射频电极的支架具有良好的伸缩率,从而增强其对血管直径的适应性,那么在手术时就可以覆盖不同直径的血管,改善设备的覆盖性。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. In the prior art, 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. Therefore, if 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.

此外,现有的射频消融导管对弯曲血管的适应性普遍较差,绝大部分的射频消融导管在弯曲血管内电极根本无法贴壁。因此,如果新的射频消融导管可以同时改善对弯曲血管的覆盖性,将极大地扩展射频消融术的应用范围,并同时提高射频消融效果,对射频消融术的推广具有积极的作用。 In addition, 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.

发明内容Summary of the invention

本发明所要解决的首要技术问题在于提供一种具有瓣状支架结构的射频消融导管。该射频消融导管对不同直径血管以及弯曲血管均具有良好的适应性,覆盖性较广。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.

本发明所要解决的另一技术问题在于提供一种包含上述射频消融导管的射频消融设备。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.

为实现上述的发明目的,本发明采用下述技术方案:In order to achieve the above object, the present invention adopts the following technical solutions:

一种具有瓣状支架结构的射频消融导管,包括由同一空心管材加工而成的瓣状支架,所述瓣状支架包括绕中心轴线按照圆形分布的多根支架丝,以及和所述支架丝一体的一个或者两个连接管;其中,每根支架丝的长度方向顺着所述空心管材的长度方向延伸,所述支架丝的两端分别聚拢构成所述瓣状支架的远端和近端,在每根所述支架丝的中间段内分别设置有一个或多个电极,所述瓣状支架的中间段有收缩状态和扩展状态。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.

其中较优地,所述管材的中部形成分离的多根支架丝,所述管材的两端分别形成两个与所述支架丝一体的连接管;或者,所述管材的中部形成分离的多根支架丝,所述管材的一端形成与所述支架丝一体的连接管,所述管材的另一端形成所述支架丝的分离的末端。Preferably, 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.

其中较优地,所述瓣状支架还包括设置于中心轴位置的中心拉丝,所述中心拉丝的一端与所述瓣状支架的远端固定或者穿出所述瓣状支架的远端并被限制在所述瓣状支架的外侧,另一端穿过所述瓣状支架的中心后从近端穿出,所述中心拉丝可相对于所述近端沿轴向拉动所述瓣状支架,使其向外扩展,并且,所述中心拉丝可以相对于所述瓣状支架向所述瓣状支架的远端滑移。Preferably, 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.

其中较优地,所述瓣状支架的支架丝被定型为中间圆柱、两端收缩状的圆柱形;或者,所述瓣状支架的支架丝被定型为中间突出、两端自然收缩的圆鼓形。Preferably, 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.

其中较优地,所述电极的圆周上设置有开口。Preferably, the electrode is provided with an opening on the circumference thereof.

其中较优地,多个电极的轴向投影在所述瓣状支架的轴向上不重叠。Preferably, the axial projection of the plurality of electrodes does not overlap in the axial direction of the lobed stent.

其中较优地,多个所述电极在所述瓣状支架的圆周面展开图上呈 一条直线排列或交错排列成多条直线。Preferably, 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.

其中较优地,所述瓣状支架设置有防倒伏结构,所述防倒伏结构是固定在多根支架丝上的防倒伏筋。Preferably, the lobed stent is provided with an anti-floating structure, and the anti-floating structure is an anti-floating rib fixed on the plurality of stent wires.

其中较优地,所述瓣状支架的近端连接有多孔管,中心拉丝的一端固定在所述瓣状支架的远端或者被限制在所述瓣状支架的远端的外侧并可相对于所述瓣状支架的远端自由滑移,另一端穿过多孔管的中心孔;所述电极内穿所述支架丝、热电偶丝和射频线,所述电极的两端分别固定在所述瓣状支架上,所述热电偶丝和所述射频线的一端固定在所述电极内,另一端穿过多孔管上的对应孔与外接设备连接。Preferably, 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.

其中较优地,所述射频线和所述热电偶丝制作成同一丝材。Preferably, the radio frequency wire and the thermocouple wire are made into the same wire.

一种射频消融设备,包括上述的射频消融导管、与所述射频消融导管连接的控制手柄和射频消融主机。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.

本发明提供的射频消融导管采用由同一管材加工而成的瓣状支架。该瓣状支架具有良好的伸缩性,并且电极的排列形态在扩展贴壁后可以满足特定的要求,使得当瓣状支架在不同直径的血管内自动扩展和被拉动时,多个电极均能全部贴壁,并且多个电极在轴向上不重叠,不会造成过度消融。该瓣状支架的伸缩性较好,对不同直径的血管的覆盖性较广,至少可以满足4~12mm血管的射频消融要求。同时,上述瓣状支架对弯曲血管也具有较好的覆盖性。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. At the same time, the above-mentioned valvular stent also has good coverage for curved blood vessels.

附图说明DRAWINGS

图1是本发明提供的瓣状支架的结构示意图;1 is a schematic structural view of a petal stent provided by the present invention;

图2是本发明提供的瓣状支架中,多电极第一种排布结构示意图;2 is a schematic view showing a first arrangement of a plurality of electrodes in a valvular stent provided by the present invention;

图3是本发明提供的瓣状支架中,多电极第二种排布结构示意图;3 is a schematic view showing a second arrangement of a plurality of electrodes in a valvular stent provided by the present invention;

图4是本发明提供的瓣状支架中,多电极第三种排布结构示意图;4 is a schematic view showing a third arrangement of a plurality of electrodes in a valvular stent provided by the present invention;

图5是本发明提供的瓣状支架中,在同一根支架丝上设置多个电极的结构示意图;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; FIG.

图6是本发明提供的瓣状支架中,第一种防倒伏结构的示意图;Figure 6 is a schematic view showing the first anti-falling structure of the petal stent provided by the present invention;

图7是本发明提供的瓣状支架中,第二种防倒伏结构的示意图;Figure 7 is a schematic view showing a second anti-falling structure in the petal stent provided by the present invention;

图8是本发明提供的瓣状支架中,电极的三种结构示意图;Figure 8 is a schematic view showing three structures of electrodes in the valve-shaped stent provided by the present invention;

图9是血管较细时,瓣状支架中电极贴壁的动作原理图;Figure 9 is a schematic view showing the action of electrodes adhering to the valvular stent when the blood vessel is thin;

图10是血管较粗时,瓣状支架中电极贴壁的动作原理图。 Fig. 10 is a schematic view showing the operation of the electrode in the petal stent when the blood vessel is thick.

具体实施方式detailed description

下面结合附图和具体实施例对本发明的技术内容进行详细具体的说明。为便于说明,以下将靠近操作者(远离消融部位)的一端称为近端,将远离操作者(靠近消融部位)的一端称为远端。The technical content of the present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. For convenience of explanation, the end near the operator (away from the ablation site) is referred to as the proximal end, and the end remote from the operator (near the ablation site) is referred to as the distal end.

如图1所示,本发明提供的射频消融导管包括由同一空心管材加工而成的瓣状支架1,瓣状支架1在血管内扩展后外形类似灯笼的骨架。瓣状支架1包括绕中心轴线按照圆形分布的多根支架丝2,以及和支架丝2一体的一个或者两个连接管。具体来说,在瓣状支架1中,每根支架丝2的长度方向沿着空心管材的长度方向延伸,所有支架丝2的两端分别聚拢构成瓣状支架1的远端和近端,在每根支架丝2的中间段内分别设置有一个或一个以上的电极4(参见图1和图5),瓣状支架的中间段有收缩状态和扩展状态两种,支架丝2的中间段在消融部位的管腔内可以扩展贴壁。当瓣状支架1在血管内扩展贴壁后,在血管壁的作用下,瓣状支架1的中部形成一个具有一定长度的水平段(参见图1的B区域),设置在支架丝2的中间段上的电极4与血管壁贴壁状态良好。As shown in FIG. 1 , 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. Specifically, in the petal stent 1, the length direction of 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. 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.

在本发明提供的瓣状支架1中,可以在每根支架丝上设置一个或一个以上的多个电极。虽然在该技术方案中,多个电极的排布形态并不需要具有特别的形状,但是为了保证多个电极不会对血管壁造成过度消融,较优地,可以使多个电极的排布形态在瓣状支架的轴向上的投影满足不重叠的要求。这样当瓣状支架在血管内扩展时,无论血管直径粗细,多个电极在轴向上不重叠,都不会造成对血管的过度消融,避免损毁血管。In the petal stent 1 provided by the present invention, one or more electrodes may be disposed on each stent wire. Although in this technical solution, 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. Thus, when the petal stent expands in the blood vessel, regardless of the diameter of the blood vessel, the plurality of electrodes do not overlap in the axial direction, and no excessive ablation of the blood vessel is caused, and the blood vessel is prevented from being damaged.

下面结合图2至图5对多个电极在支架丝2上的具体排布情况进行举例说明。The specific arrangement of the plurality of electrodes on the stent wire 2 will be exemplified below with reference to FIGS. 2 to 5.

图2至图4中给出了6个电极在瓣状支架1的圆周面展开图上的三种排布形状,在图2至图4所示的实施例中,在瓣状支架1的每根支架丝上固定有一个电极。将6条支架丝2从上到下依次标记为#1丝至#6丝。在图2所示的实施例中,6个电极从左上到右下依次分布在每根支架丝上的B区内,排列成一条直线;在图3和图4所示的两个实施例中,6个电极从左上到右下交错排列,排列成2条直线。虽然 在上述三个实施例中,6个电极在瓣状支架的外圆周面上排列成螺旋形,但是这并不意味着多个电极需要在瓣状支架的外圆周面上规则排列,在其他未给出具体结构图的实施例中,多个电极还可以在瓣状支架的展开图上无序排列,或者排列成其他形状。在实际消融手术时,只需根据单个电极所处的位置对其附近的神经组织进行消融即可。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. In the embodiment shown in FIG. 2, 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. Although In the above three embodiments, 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.

此外,在图5所示的瓣状支架中,在每个支架丝上固定有两个电极。而在其他未图示的实施例中,在每个支架丝上还可以设置两个以上的多个电极。当在每个支架丝上设置多个电极时,多个电极在瓣状支架的轴向上很容易重叠(如图5所示),相对于简单的螺旋设置或者均布设置可能存在一定风险,但这并不意味着,多个电极不能在瓣状支架的圆周面的投影及轴向投影上发生重叠。也就是说,本发明所提供的瓣状支架中,主要着重于强调支架丝与设置在其两端或一端的连接管的一体设置结构,对在支架丝上固定的电极的数量和排布形态并不具有特殊要求。Further, in the petal stent shown in Fig. 5, two electrodes are fixed to each stent wire. In other embodiments not shown, more than two electrodes may be disposed on each of the stent wires. When a plurality of electrodes are 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. However, this does not mean that a plurality of electrodes cannot overlap on the projection and axial projection of the circumferential surface of the lobes. That is to say, in the lobed stent provided by the present invention, 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.

本发明提供的瓣状支架1的两端可以全部封闭,也可以一端封闭,一端开口,其具体结构可以参见图6和图7。在图6所示的结构中,瓣状支架1的两端封闭。管材的中部经过加工形成分离的多根支架丝2,管材的两端未经过加工分别形成两个与支架丝2一体的连接管11。而在图7所示的结构中,瓣状支架1的一端封闭,另一端开口。管材的中部经过加工形成分离的多根支架丝2,管材的一端形成与支架丝2一体的连接管13a,管材的另一端经过加工形成支架丝2的彼此分离的末端13b。在图7所示的结构中,支架丝2的末端聚拢但彼此互不相连,方便穿入并设置电极。瓣状支架1开口的一端可用作远端,也可作为近端,在组装瓣状支架时,通常在瓣状支架1开口的一端设置连接头进行封闭后再与其他部件(例如多孔管7)进行组装。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. In the structure shown in Fig. 6, 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. In the structure shown in Fig. 7, 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. In the structure shown in Fig. 7, 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. When assembling the petal stent, 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.

上述瓣状支架1由同一空心管材加工而成,当然也可以先由其他型材或棒材经过加工获得空心管材后,再加工而成。可以采用雕刻工艺对具有记忆功能的圆形管材进行加工,然后膨胀定形,从而在管材的中部形成分离的支架丝2,并在支架丝2的一端或两端形成与其一体的连接管。在这种一体成型的瓣状支架中,多根支架丝2具有良好的力学性能,防止其倒伏变形;并且,支架丝2具有良好的伸缩性, 可以在不同直径的血管内扩展贴壁。瓣状支架1可以使用钛合金、记忆合金等材料加工,瓣状支架1也可以由高分子材料加工而成。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. In the integrally formed valvular stent, 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.

在使用空心管材加工瓣状支架的过程中,支架丝2成型后可以进行定型处理,也可以不进行定型处理直接组装后使用。当支架丝2经过定型后,可以被定型为中间圆柱、两端收缩状的圆柱形;也可以被定型为中间突出、两端自然收缩的圆鼓形。无论是圆柱形还是圆鼓形的支架,当其在血管内扩展贴壁后,支架丝都可以在血管壁的作用下变形为如图1所示的形状,从而保证设置在支架丝中间段上的电极贴壁良好。In the process of processing the valvular stent by using the hollow tube, the stent wire 2 may be shaped after being formed, or may be directly assembled after being used for the styling process. 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. Whether it is a cylindrical or round-shaped stent, 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.

为了防止支架丝2在血管内部扩展之后发生倒伏,本发明在瓣状支架1上还设置有防倒伏结构,防倒伏结构有多种,具体来说是指固定在多根支架丝2上的防倒伏筋,通过使用防倒伏筋将多根支架丝2连接在一起,当瓣状支架1扩展时,可以保证支架丝2向外扩展不倒伏。在实际使用中,可以在一个瓣状支架1上设置多根防倒伏筋。防倒伏结构可以是如图6所示的固定在多根支架丝2上的斜型防倒伏筋12,也可以是如图7所示的固定在多根支架丝2上的V型防倒伏筋14。但是,需要说明的是,虽然防倒伏筋在一定程度上增强了瓣状支架的结构强度,但其长度和倾斜度设置也可能在一定程度上制约瓣状支架的对外扩展性能,也就是说限制瓣状支架所能适应的最大血管直径,因此,在设计防倒伏筋时,需要结合覆盖的血管范围,合理设计防倒伏筋的长度和倾斜度。In order to prevent the stent wire 2 from lodging after expanding inside the blood vessel, 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. When the lobes 1 are expanded, the stent wires 2 can be expanded outward without lodging. In actual use, 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. 6, or may be a V-shaped anti-floating rib fixed on the plurality of support wires 2 as shown in FIG. 14. However, it should be noted that although 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.

为了将电极4顺利地设置在支架丝2上,本发明提供了几种不同形状的电极4,例如电极4的中心可以开设圆孔,电极4的圆周上也可以设置开口。在图8给出的3种电极形状示例中,靠左侧的两个电极中心圆孔较大,在组装时比较容易将热电偶丝5和射频线6固定在其内部,而右侧电极中心未开设圆孔,其内部空间较小,较难组装。另一方面,左侧电极圆周上没有设置开口,仅适于一端封闭、一端开口的瓣状支架1的组装,不适于两端封闭且一体成型的瓣状支架1使用;而靠右侧的两个电极由于圆周上设置有开口,比较适于两端封闭的瓣状支架1的组装,同时也可以用于一端开口一端封闭的瓣状支架1。也就是说,当在一体成型的两端封闭的瓣状支架1上组装电极4时, 需要使用圆周上设置有开口的电极4,从而方便将电极4卡在支架丝2上,然后通过将电极4的两端固定在支架丝2上,完成电极4的设置。由于电极4的中心空间狭小,在实际组装时,设置在其内部的热电偶丝和射频线可以制作成同一丝材进行固定。In order to smoothly arrange the electrode 4 on the stent wire 2, the present invention provides several electrodes 4 of different shapes. For example, the center of the electrode 4 may have a circular hole, and the electrode 4 may have an opening on the circumference thereof. In the three electrode shape examples given in FIG. 8, 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. On the other hand, 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. That is, when the electrode 4 is assembled on the integrally formed flap-shaped stent 1 which is closed at both ends, It is necessary to use the electrode 4 provided with an opening on the circumference, thereby facilitating the chucking of the electrode 4 on the stent wire 2, and then fixing the electrode 4 by fixing the both ends of the electrode 4 to the stent wire 2. Since the center space of the electrode 4 is narrow, in actual assembly, the thermocouple wire and the RF wire provided inside can be made to be fixed by the same wire.

此外,为了控制瓣状支架1在血管内实现收缩或扩展,在瓣状支架1的中心轴位置还设置有中心拉丝3。如图1所示,中心拉丝3的一端固定在设置于瓣状支架1远端的连接管内,另一端穿过瓣状支架1内部从瓣状支架1的近端穿出,并且,该中心拉丝穿过与瓣状支架1的近端连接的多孔管7的中心孔延伸到设置于导管末端的控制手柄上。中心拉丝3在外力作用下可以相对瓣状支架1的近端和多孔管7沿轴向拉动瓣状支架1,以使瓣状支架扩展变形。当经过定型的瓣状支架1在较细的血管内受到血管壁挤压发生收缩变形时,中心拉丝3可以自动滑移;当从外部向后拉动中心拉丝3时,瓣状支架1会发生进一步扩张,其直径变大,从而使多个电极可以在直径较粗的血管内实现贴壁。此外,当从外部使用外力向前推送中心拉丝3时,可以使瓣状支架1收缩,从而可以在血管内移动瓣状支架1的位置或者将瓣状支架1从血管内撤出体外,在该移动过程中,可以避免瓣状支架1对血管壁的损伤。Furthermore, in order to control the contraction or expansion of the petal stent 1 within the blood vessel, a central wire drawing 3 is also provided at the central axis position of the petal stent 1. As shown in FIG. 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. When the shaped petal stent 1 is contracted and deformed by the blood vessel wall in a thin blood vessel, 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. When expanded, the diameter thereof becomes large, so that a plurality of electrodes can be attached in a blood vessel having a relatively large diameter. Further, 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.

此外,在未图示的实施例中,中心拉丝的远端还可以不和瓣状支架一体成型的连接管固定,而是穿出瓣状支架远端的连接管后与射频消融导管的头端固定在一起,从而中心拉丝的远端被限制在瓣状支架的远端的外侧;中心拉丝的近端穿过瓣状支架的内部并从瓣状支架的近端的中心穿出。所以,在该实施例中,中心拉丝可相对于连接管沿轴向拉动瓣状支架,使其向外扩展,同时,中心拉丝也可以相对于连接管和瓣状支架向瓣状支架的远端自由滑移。In addition, in the embodiment not shown, 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. Therefore, in this embodiment, 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.

下面结合图1、图9和图10对经过定型的瓣状支架的伸缩性进行介绍。当闭合的瓣状支架从鞘管内伸出后会发生自然扩张,如图1所示,假定瓣状支架1自然扩张后的初始外侧直径为A mm。当消融血管直径小于A mm时,如图9所示,瓣状支架1在自动扩张的过程中受到血管壁的挤压,此时,各个电极4在血管壁的挤压力F作用下,实现完全贴壁,接触状态良好。而当消融血管直径大于等于A mm时,瓣状 支架在自然扩张后并未完全接触血管壁,如图10所示,通过施加拉力F2向外部拉动中心拉丝3,瓣状支架1长度缩小,支架丝2向外膨出,呈扩张状态;在该过程中,电极4向血管壁方向移动,并逐步实现贴壁,与血管壁接触良好。The flexibility of the shaped valvular stent will be described below with reference to Figs. 1, 9, and 10. When the closed petal stent protrudes from the sheath, natural expansion occurs, as shown in Fig. 1, assuming that the initial lateral diameter of the petal stent 1 after natural expansion is A mm. When the diameter of the ablation vessel is less than A mm, as shown in FIG. 9, the valvular stent 1 is squeezed by the vessel wall during the automatic expansion. At this time, the respective electrodes 4 are under the action of the squeezing force F of the vessel wall. Fully attached and in good contact. When the diameter of the ablation vessel is greater than or equal to A mm, the flap The stent does not completely contact the vessel wall after natural expansion. As shown in FIG. 10, 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.

本发明提供的射频消融导管中使用的瓣状支架,除可以使用上述在组装前经过定型处理的支架外,还可以使用在组装前未对支架丝做过定型处理的支架。对于该种未经过定型处理的瓣状支架,当射频消融导管从鞘管内伸出时,瓣状支架无法自然扩张,此时通过拉动中心拉丝,也可以确保设置在中间段上的多个电极同时贴壁,并且,在瓣状支架扩展贴壁后,多个电极的轴向投影在瓣状支架的轴向上不重叠,多个电极的周向投影均匀分布于瓣状支架的圆周截面上。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. For the unshaped valvular stent, when the radiofrequency ablation catheter protrudes from the sheath, 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.

此外,如图1所示,在本发明提供的射频消融导管中,还包括多孔管7,多孔管7与瓣状支架的近端连接;在瓣状支架的内部设置的中心拉丝3的一端固定在瓣状支架的远端,另一端穿过瓣状支架的近端和多孔管7的中心孔,延伸到导管外部,与控制手柄连接。在每个电极4内穿设有支架丝2、热电偶丝5和射频线6,电极4的两端分别固定在支架丝2上,热电偶丝5和射频线6的一端固定在电极4内,另一端穿过多孔管7上的对应孔与外接设备连接。由于瓣状支架对不同直径血管的覆盖性较好,包含上述瓣状支架的同一射频消融导管可以用于不同病人的射频消融,设备覆盖性较好。In addition, as shown in FIG. 1, in the radio frequency ablation catheter provided by the present invention, 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. A bracket wire 2, a 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.

在本发明提供的瓣状支架中还设置有中心穿刺针,中心穿刺针在瓣状支架扩展贴壁时突出于支架表面刺入血管壁内,实施穿刺注射;当在瓣状支架收缩时,中心穿刺针收缩于瓣状支架的内部。In the lobed stent provided by the present invention, 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.

同时,本发明提供的瓣状支架对弯曲血管也具有良好的适应性,当上述瓣状支架在弯曲血管内扩展贴壁后,其整体可以弯曲适应血管的形状,而且设置在其中间段上的多个电极可以同时贴壁。At the same time, the valvular stent provided by the invention has good adaptability to the curved blood vessel. When the valvular stent is expanded and attached in 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.

在实际临床治疗中,本发明所提供的射频消融导管及射频消融设备可以应用于不同部位、多种不同直径血管或气管的神经消融。例如,应用于肾动脉内神经消融治疗顽固性高血压患者,应用于腹腔动脉内神经消融治疗糖尿病患者,又如,应用于气管/支气管迷走神经分支消融治疗哮喘患者,以及应用于十二指肠迷走神经分支消融治疗十二指 肠溃疡患者;此外,还可以用于肾盂内、肺动脉内等其他血管或气管内的神经消融。需要说明的是,本发明所提供的射频消融导管在临床治疗中并不限于上述列举的应用,还可用于其他部位的神经消融。In actual clinical treatment, 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. For example, 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. For example, it is applied to the treatment of asthma patients with tracheal/bronchial vagal branch ablation, and for duodenal vagus nerve. Branch ablation treatment of twelve fingers Intestinal ulcer patients; in addition, it can also be used for nerve ablation in other blood vessels or trachea, such as the renal pelvis and pulmonary artery. It should be noted that 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.

上面对本发明提供的射频消融导管进行了介绍,本发明同时提供了包括上述射频消融导管的射频消融设备。该射频消融设备除去包括上述射频消融导管外,还包括与上述射频消融导管连接的控制手柄和射频消融主机。其中,瓣状支架中的中心拉丝穿过多孔管后连接到控制手柄上,通过控制手柄可以控制射频消融导管的前进、后退及弯曲。瓣状支架中的射频线、热电偶丝分别通过多孔管连接到射频消融主机中的对应电路中,从而实现射频消融主机对多个电极的射频控制和温度监测。由于控制手柄的设置和射频消融主机的设置可以参见本申请人以前申请并已公开的专利,在此不再对其具体结构进行详细描述。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.

综上所述,本发明提供的射频消融导管,由于其采用的瓣状支架由一根管材加工而成,在具有伸缩性的同时保证了强度,因而不易倒伏,并且其支架丝上设置的多个电极的排列形态在扩展贴壁时满足特定的要求,使得当瓣状支架在不同直径的血管内扩展时,多个电极均能全部贴壁,并且多个电极在瓣状支架的轴向上不重叠。该瓣状支架的伸缩性较好,对不同直径的血管的覆盖性较广,至少可以满足4~12mm血管的射频消融要求。而且,该瓣状支架同时对弯曲血管也具有良好的覆盖性。所以,本发明提供的射频消融导管和包括上述射频消融导管的射频消融设备对不同患者的射频手术具有广泛的覆盖性。In summary, 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. Moreover, 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.

以上对本发明所提供的具有瓣状支架结构的射频消融导管及其设备进行了详细的说明。对本领域的一般技术人员而言,在不背离本发明实质精神的前提下对它所做的任何显而易见的改动,都将构成对本发明专利权的侵犯,将承担相应的法律责任。 The 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.

Claims (11)

一种具有瓣状支架结构的射频消融导管,其特征在于包括由同一空心管材加工而成的瓣状支架,所述瓣状支架包括绕中心轴线按照圆形分布的多根支架丝以及和所述支架丝连为一体的连接管;其中,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 in a circular shape about a central axis, and a connecting tube in which the stent wire is connected; wherein 在每根所述支架丝的中间段内分别设置有一个或多个电极,所述瓣状支架的中间段有收缩状态和扩展状态。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. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 所述管材的中部形成分离的多根支架丝,所述管材的两端分别形成两个与所述支架丝一体的连接管;a middle portion of the tube forms a plurality of separate stent wires, and two ends of the tube respectively form two connecting tubes integral with the stent wire; 或者,所述管材的中部形成分离的多根支架丝,所述管材的一端形成与所述支架丝一体的连接管,所述管材的另一端形成所述支架丝的分离的末端。Alternatively, the middle portion of the tubing forms a plurality of separate stent wires, one end of which forms a connecting tube integral with the stent filament, the other end of which forms a separate end of the stent filament. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 所述瓣状支架还包括设置于中心轴位置的中心拉丝,所述中心拉丝的一端与所述瓣状支架的远端固定或者穿出所述瓣状支架的远端并被限制在所述瓣状支架的外侧,另一端穿过所述瓣状支架的中心后从近端穿出,所述中心拉丝可相对于所述近端沿轴向拉动所述瓣状支架,使其向外扩展,并且,所述中心拉丝可以相对于所述瓣状支架向所述瓣状支架的远端滑移。The petal stent further includes a central wire drawing disposed at a central axis position, one end of the center wire being fixed to the distal end of the petal stent or penetrating the distal end of the petal stent and being constrained to the valve The outer side of the stent is passed through the center of the petal stent and then exits from the proximal end, and the central wire can axially pull the petal stent relative to the proximal end to expand outwardly. Also, the center wire can be slid toward the distal end of the petal stent relative to the lobed stent. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 所述瓣状支架的支架丝为中间圆柱、两端收缩状的圆柱形;The stent wire of the valvular stent is a cylindrical shape with a cylindrical shape at both ends; 或者,所述瓣状支架的支架丝为中间突出、两端自然收缩的圆鼓形。Alternatively, the stent wire of the petal stent is a dome shape with a middle protrusion and a natural contraction at both ends. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 所述电极的圆周上设置有开口。An opening is provided on the circumference of the electrode. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 多个电极的轴向投影在所述瓣状支架的轴向上不重叠。The axial projection of the plurality of electrodes does not overlap in the axial direction of the lobed stent. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 所述瓣状支架设置有防倒伏结构,所述防倒伏结构是固定在多根支架丝上的防倒伏筋。 The lobed stent is provided with an anti-floating structure, and the anti-floating structure is an anti-floating rib fixed on a plurality of stent wires. 如权利要求1所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 wherein: 每根支架丝的长度方向顺着所述空心管材的长度方向延伸,所述支架丝的两端分别聚拢构成所述瓣状支架的远端和近端。The length of each of the stent wires extends along the length of the hollow tubing, and the two ends of the stent filament are respectively gathered to form the distal end and the proximal end of the petal stent. 如权利要求1或8所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 1 or 8, wherein: 所述瓣状支架的近端连接有多孔管,中心拉丝的一端固定在所述瓣状支架的远端或者被限制在所述瓣状支架的远端的外侧并可相对于所述瓣状支架的远端自由滑移,另一端穿过多孔管的中心孔;所述电极内穿所述支架丝、热电偶丝和射频线,所述电极的两端分别固定在所述瓣状支架上,所述热电偶丝和所述射频线的一端固定在所述电极内,另一端穿过多孔管上的对应孔与外接设备连接。a proximal end of the valvular stent is coupled to a porous tube, one end of the central wire is secured to the distal end of the valvular stent or is constrained to the outside of the distal end of the valvular stent and is relative to the valvular stent The distal end is free to slip, and the other end passes through the 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 on the valve holder, 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. 如权利要求9所述的射频消融导管,其特征在于:The radiofrequency ablation catheter of claim 9 wherein: 所述射频线和所述热电偶丝制作成同一丝材。The radio frequency wire and the thermocouple wire are made into the same wire. 一种射频消融设备,其特征在于包括权利要求1~10中任意一项所述的射频消融导管、与所述射频消融导管连接的控制手柄和射频消融主机。 A radio frequency ablation device comprising the radiofrequency ablation catheter of any one of claims 1 to 10, a control handle coupled to the radio frequency ablation catheter, and a radio frequency ablation host.
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