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WO2016019761A1 - 具有网管状支架结构的射频消融导管及其设备 - Google Patents

具有网管状支架结构的射频消融导管及其设备 Download PDF

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Publication number
WO2016019761A1
WO2016019761A1 PCT/CN2015/081584 CN2015081584W WO2016019761A1 WO 2016019761 A1 WO2016019761 A1 WO 2016019761A1 CN 2015081584 W CN2015081584 W CN 2015081584W WO 2016019761 A1 WO2016019761 A1 WO 2016019761A1
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
wire
tubular stent
tube
ablation catheter
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/CN2015/081584
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English (en)
French (fr)
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
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Golden Leaf Med Tec Co Ltd filed Critical Shanghai Golden Leaf Med Tec Co Ltd
Priority to US15/501,662 priority Critical patent/US20170224415A1/en
Priority to CN201590000028.3U priority patent/CN205586586U/zh
Publication of WO2016019761A1 publication Critical patent/WO2016019761A1/zh
Anticipated expiration legal-status Critical
Priority to US16/147,789 priority patent/US20190029754A1/en
Priority to US16/218,424 priority patent/US11883092B2/en
Priority to US16/574,039 priority patent/US12064167B2/en
Priority to US18/774,921 priority patent/US20240366300A1/en
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00059—Material properties
    • A61B2018/00071—Electrical conductivity
    • A61B2018/00083—Electrical conductivity low, i.e. electrically insulating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A61B2018/00821—Temperature measured by a thermocouple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the invention relates to a radio frequency ablation catheter, in particular to a radio frequency ablation catheter having a mesh tubular stent structure, and to a radio frequency ablation device comprising the radio frequency ablation catheter, belonging 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 human blood vessels varies from person to person. At the same time, the diameter of blood vessels in human body varies with the location of ablation. Most of the diameters of human blood vessels are between 2 and 12 mm, which is quite different.
  • the telescopic size of the electrode end of a single radiofrequency ablation catheter is usually fixed, and it is not suitable for the diameter of blood vessels of different human bodies, 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 catheters generally have poor adaptability to curved vessels.
  • Most radiofrequency ablation catheters do not adhere to the electrodes in the curved vessels. Therefore, if the new radiofrequency ablation catheter can simultaneously improve the coverage of the curved vessels. Sex, will greatly expand the application range of radiofrequency ablation, and at the same time improve the radiofrequency ablation effect, the promotion of radiofrequency ablation Has a positive effect.
  • the primary technical problem to be solved by the present invention is to provide a radiofrequency ablation catheter having a mesh tubular stent structure, which 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 radio frequency ablation catheter having a mesh tubular stent structure, comprising a mesh tubular stent disposed at a front end of the catheter, the mesh tubular stent comprising a mesh tube; and the two ends of the mesh tube are gathered to form a distal end of the tubular stent And at the proximal end, the intermediate section of the tubular tubular stent has a contracted state and an expanded state, and one or more electrodes are fixed to the wire of the intermediate section of the mesh tubular stent.
  • the mesh tube is shaped into an intermediate cylinder and contracted at both ends before assembly, and the shape is cylindrical after assembly.
  • the mesh tube is shaped into a cylindrical shape before assembly, and the assembled shape is a circular drum shape which is protruded in the middle and naturally contracts at both ends.
  • the radio frequency wire and the thermocouple wire which are disposed inside the electrode are further included;
  • the radio frequency wire, the thermocouple wire and the wire are respectively independent wires; or, a part of the wire has the function of the radio frequency wire; or the radio frequency wire and the thermocouple wire are made into The same wire.
  • the axial projections of the plurality of electrodes do not overlap in the axial direction of the mesh tubular support.
  • a plurality of the electrodes are arranged in a straight line or staggered in a plurality of straight lines on the developed surface of the mesh tube.
  • the first connecting tube and the second connecting tube are respectively disposed at two ends of the mesh tube;
  • the mesh tubular support further includes a central wire drawn on the central shaft, one end of the center wire is fixed to or passed through the first connecting pipe provided at the distal end of the mesh tubular support and is Restricted to the outside of the first connecting tube, the other end of the center wire is passed through the inside of the mesh tubular bracket and from the proximal end of the tubular tubular bracket a center of the second connecting tube is pierced; the center wire drawing axially pulls the mesh tubular bracket relative to the second connecting tube, and the center wire drawing may be opposite to the second connecting pipe The distal end of the mesh tubular stent slides.
  • the proximal end of the mesh tubular support is connected with a porous tube, and one end of the central wire is fixed at the distal end of the mesh tubular support or is limited to the outer side of the distal end of the mesh tubular support and Freely sliding relative to the distal end of the tubular stent, the other end of the central wire is passed through a central hole of the porous tube; the electrode is inserted through a thermocouple wire, a radio frequency wire and a wire, and two of the electrodes The ends are respectively fixed on the mesh tubular support, one end of the thermocouple wire and the radio frequency wire is fixed in the electrode, and the other end is connected to the external device through a corresponding hole on the porous tube.
  • the electrode is provided with an opening on the circumference thereof.
  • the mesh tube is woven from a single wire or a plurality of wires, or the mesh tube is processed from a metal material or a polymer material.
  • 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 with the mesh tubular stent structure provided by the invention adopts the mesh tubular stent to install the radio frequency electrode, and the mesh tubular stent has good flexibility, so that when the tubular tubular stent expands and is pulled in different blood vessels, All electrodes can be attached to the wall. Also, by arranging a plurality of electrodes provided on the tubular stent of the mesh, they do not overlap in the axial direction of the mesh tubular stent, so that excessive ablation is not caused.
  • the tubular stent of the mesh has better flexibility, and the coverage of blood vessels of different diameters is good, and at least the radiofrequency ablation requirement of the blood vessel of 4 to 12 mm can be satisfied. At the same time, the above-mentioned mesh tubular stent also has good coverage for curved blood vessels.
  • FIG. 1 is a schematic structural view of a mesh tubular stent in a first embodiment provided by the present invention
  • Figure 2a is a schematic view showing the structure of a cylindrical mesh tube having a cross section of 12 wires
  • Figure 2b is a schematic cross-sectional view of the cylindrical mesh tube of Figure 12a having a cross section of 12 filaments;
  • Figure 3a is a schematic view showing the structure of a cylindrical mesh tube having a cross section of 18 filaments
  • Figure 3b is a schematic cross-sectional view of the cylindrical mesh tube of Figure 18a having a cross-section of 18 filaments;
  • Figure 4 is a schematic view showing the axial projection of the six electrodes without overlapping in the axial direction of the tubular tubular support;
  • Figure 5 is a schematic view showing the circumferential projection of six electrodes uniformly distributed on the circumferential section of the tubular tubular support
  • Figure 6 is a schematic view showing the structure of six electrodes mounted on a mesh tube having 12 wires in cross section;
  • Figure 7 is a schematic view showing the structure of six electrodes mounted on a mesh tube having a cross section of 18 wires;
  • Figure 8 is a schematic view showing the structure of six electrodes mounted on a mesh tube having 24 wires in cross section;
  • Figure 9 is a schematic view showing the action of electrodes adhering to the mesh tubular stent when the blood vessel is thin;
  • Figure 10 is a schematic cross-sectional view of the tubular stent of Figure 9;
  • Figure 11 is a schematic view showing the action of electrode attachment in a mesh tubular stent when the blood vessel is thick;
  • Figure 12 is a schematic view showing the structure of the mesh tube after being shaped into a cylindrical shape in the second embodiment
  • Figure 13 is a schematic view showing the structure of the assembled circular drum-shaped tubular stent in the second embodiment
  • 14a, 14b, 14c, and 14d are respectively experimental results of the same mesh tubular stent after being expanded in a simulated blood vessel with a diameter of 4 mm, 6 mm, 8 mm, and 12 mm; wherein, the simulated blood vessel having a diameter of 6 mm in Fig. 14b With curvature;
  • 15a and 15b are respectively experimental results of the stent of the mesh tubular stent after being automatically expanded in the same coarser simulated blood vessel and after being pulled and attached.
  • 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 front end of the radiofrequency ablation catheter provided by the present invention has a mesh tubular support, and the mesh tubular support comprises a mesh tube 1.
  • the mesh tube 1 can be woven from a single wire or a plurality of wires.
  • the mesh tube 1 can also be processed from a polymer material or a metal material.
  • the mesh tube 1 can be made of a polymer material or a metal material by engraving, machining, powder metallurgy, injection molding, or 3D printing. Processing means are obtained.
  • the shape of the mesh tube 1 can be shaped or unshaped before assembly, and the shape of the mesh tube 1 can be deformed during the assembly process and the expansion process. After assembly, the two ends of the mesh tube 1 are respectively gathered to form a net.
  • the distal end and the proximal end of the tubular stent, and the connecting tubes 4 and 5 are respectively disposed at the two ends of the mesh tube 1; the intermediate portion of the mesh tubular stent has a contracted state and an expanded state, and the middle portion of the mesh tube 1 (see One or more electrodes 2 are fixed to the wire of the A region of Fig. 2, and the intermediate portion of the mesh tube 1 can be expanded in the lumen of the ablation site.
  • the braiding density and the stretchability of the stent are preferably controlled within 30 strands of the cross-section of the mesh tube 1.
  • the mesh tube 1 before assembling the tubular tubular bracket, the mesh tube 1 is first shaped into a middle cylinder, the ends are contracted, and the two are connected at an oblique angle, and the angle can be 10° to 90°. And perform a circular arc transition (see Fig. 2); thus, the overall shape of the tubular tubular support after assembly is cylindrical as shown in Fig. 1.
  • the mesh tube is shaped into a cylindrical shape (see FIG.
  • the overall shape of the mesh tubular support 10 exhibits a circular shape as shown in FIG. 13 with an intermediate protrusion and a natural contraction at both ends.
  • the mesh tube 1 is first shaped into an intermediate cylinder and the ends are contracted (see Fig. 2). Specifically, a transition region having a certain inclination angle is disposed between the intermediate cylindrical section (region A) and the contracted end section ( ⁇ B section), and preferably the inclination angle of the transitional region is between 10° and 90°.
  • the two ends of the transition region respectively pass through a circular arc transition with the cylindrical segment and the contracted segment, and the diameter of the contraction segment is equivalent to the diameter of the ablation catheter; when assembled, the contracted segments of the mesh tube 1 are respectively first and first The connecting tube 4 and the second connecting tube 5 are fixed such that the overall shape of the tubular tubular holder after assembly is cylindrical as shown in FIG.
  • 2a, 2b, 3a and 3b are schematic views showing the structure of a cylindrical mesh tube 1 comprising 12 wires and 18 wires, respectively.
  • a cylindrical mesh tube 1 comprising 12 wires and 18 wires, respectively.
  • the length of the mesh tubular stent ensures that a suitable number of electrodes can be arranged in the middle segment while ensuring sufficient flexibility in the 2 to 10 mm blood vessel, so that the length of the mesh tubular stent is shorter.
  • thermocouple wire 6 and an RF line 7 penetrating inside each electrode 2 are also included.
  • a single wire woven mesh tube 1 a single nickel-titanium wire, a stainless steel wire or other filamentous material (for example, a medical polymer material) can be independently woven into a bracket, and a thermocouple wire 6 and a radio frequency are disposed on the bracket.
  • the galvanic wire 6 can be a separate wire material, and the thermocouple wire 6 and the RF wire 7 are respectively entangled with the mesh tubular support, and the mesh wire, the RF wire 7, and the thermocouple wire 6 each perform their duties; or, the thermocouple wire 6 and the RF wire 7 can also be made into the same wire, so that the RF wire 7 and the thermocouple wire 6 are integrated, and then entangled with the mesh tubular support.
  • the mesh tube 1 When a plurality of wires are used to woven the mesh tube 1, the mesh tube 1 may be directly woven using a plurality of wires as described above, and the thermocouple wire 6 and the RF wire 7 may be disposed on the mesh tube 1;
  • the wire that is, the mesh for fixing the electrode 2 is replaced by the RF wire 7 (or the same wire including the RF wire 7 and the thermocouple wire 6), so that the partial wire has the RF line function, and the plurality of RF lines 7
  • the mesh tube 1 is formed by weaving together with the remaining plurality of wires.
  • thermocouple wires 6 may be respectively entangled with the RF wires 7, and the plurality of electrodes 2 are respectively fixed at The RF line 7 in the mesh tube 1 is on.
  • a plurality of wire woven mesh tubes 1 a plurality of RF wires 7 and a plurality of wires may be respectively wound together as a braided wire, and a plurality of the above-mentioned braided wires are woven together with other wires to form a mesh.
  • Tube 1 that is to say, the tubular stent of the mesh is not limited to a structure in which a mesh tube is woven by a single wire, and other structural deformations are possible.
  • each wire (or RF wire) needs to be insulated, and the insulating layer can be directly formed on the mesh, or the electrode can be fixed on the mesh, and then the electrode is removed from the mesh. The rest is insulated.
  • One or more electrodes may be attached to each of the wires used to make the tubular stent, or no electrodes may be provided. For example, when 12 mesh wires are used to weave a mesh tube including 24 wires in a cross section, an electrode is respectively disposed on 6 of the mesh wires, and a mesh tubular stent having a higher strength can be prepared, and 6 electrodes are The distribution on the mesh tubular stent does not cause excessive ablation.
  • two mesh wires can be used to weave a mesh tube including six mesh wires in a cross section, and six electrodes can be respectively disposed on each mesh wire so as to be woven to be evenly distributed on the outer surface of the mesh tube.
  • FIG. 4 and FIG. 5 are schematic diagrams showing the structure of the mesh tubular support provided by the present invention, wherein the electrode is disposed on the mesh tube 1 as an example, and the following description is made by taking six electrodes on the cylindrical mesh tube 1 as an example. , only the number of wires in the cross section of the mesh tube is used as a parameter As mentioned, the number of specific braided wires is not considered.
  • the mesh tubular stent provided by the present invention six electrodes 2 are disposed on the circumferential surface of the intermediate section. As can be seen from FIG. 4, when the tubular tubular stent is expanded, the axial projection of the six electrodes 2 is in the tubular tubular stent. The axial directions do not overlap. As can be seen from Fig.
  • the arrangement pattern of the plurality of electrodes is arranged in a spiral shape on the circumferential surface of the mesh tubular support, this does not mean that the arrangement form of the plurality of electrodes needs to have a special shape, in order to secure a plurality of electrodes.
  • the wall is adhered and the ablation effect is ensured, and the plurality of electrodes do not overlap each other in the axial projection of the mesh tubular stent, so that when the tubular stent is expanded in the blood vessel, regardless of the diameter of the blood vessel, each electrode does not cause the blood vessel. Excessive ablation to avoid damage to blood vessels.
  • FIG. 6 is the first embodiment of the present invention.
  • the cross-section of the mesh tube 1 includes 12 wires, 18 wires, and 24 wires, respectively.
  • a circumferential surface is provided 6 A schematic of the electrodes.
  • the order of the six electrodes 2 on the developed view of the mesh tube 1 is sequentially labeled from the upper left to the lower right as the #1 electrode to the #6 electrode.
  • the six electrodes are staggered in a circular pattern of two straight lines on the circumferential development view of the mesh tube 1 including 12 filaments in cross section, as shown in Figs. 7 and 8.
  • the six electrodes are sequentially arranged from the upper left to the lower right in a circumferentially developed view of the mesh tube 1 including 18 wires and 24 wires in a cross section, and are respectively arranged in a straight line, thereby In the embodiment, the six electrodes are arranged in a spiral shape on the circumferential surface of the mesh tube.
  • the six electrodes are regularly arranged on the circumferential surface of the mesh tubular support, this does not mean that the plurality of electrodes must be regularly arranged on the circumferential surface of the mesh tubular support, and the other is not given.
  • the plurality of electrodes may also be arranged in an unordered manner on the circumferential surface development view of the mesh tube 1, and of course, the plurality of electrodes may be arranged in other shapes.
  • the electrodes are provided on the dome-shaped mesh tube is similar, and will not be described again in the second embodiment.
  • the two ends of the mesh tubular support provided by the present invention are respectively provided with a first connecting tube 4 and a second connecting tube 5 , and the first connecting tube 4 is disposed at the distal end of the mesh tubular bracket, and the second connecting tube 5 is placed at the proximal end of the tubular stent.
  • the center of the electrode 2 provided by the present invention may have a circular hole, and an opening may be provided on the circumference of the electrode 2.
  • the center of the electrode 2 is provided with a circular hole, the mesh can be woven after the electrode is fixed on the wire, and the internal space is large, and assembly is performed.
  • thermocouple wire 6 and the RF wire 7 It is relatively easy to fix the thermocouple wire 6 and the RF wire 7 inside thereof; and an opening is provided on the circumference of the electrode 2, so that the electrode 2 can be conveniently stuck on the assembled mesh tube 1, and then both ends of the electrode 2 are It is fixed on the wire to complete the setting of the electrode 2.
  • the direction in which the electrode 2 is disposed is consistent with the direction in which the wire extends. Therefore, it is generally not parallel to the main axis of the tubular tubular support, and is inclined at an angle to the main axis; the inclination angle of the electrode 2 during the contraction or expansion of the mesh tubular support The change will occur; when the web tubular support contracts, the tilt angle decreases, and as the web tubular support expands, the tilt angle increases and gradually approaches the vertical direction.
  • a central wire drawing 3 is also disposed in the mesh tubular stent.
  • one end of the center wire 3 is fixed in the first connecting tube 4 disposed at the distal end of the mesh tubular support, the other end passes through the inside of the mesh tubular support and then from the second end disposed at the proximal end of the mesh tubular support.
  • the connecting tube 5 is threaded out and the central wire 3 extends through the central opening of the perforated tube 8 connected to the proximal end of the mesh tubular stent to a control handle disposed at the end of the catheter.
  • the central wire drawing 3 can axially pull the mesh tubular support relative to the second connecting pipe 5 and the porous pipe 8 by an external force.
  • the center wire 3 can also be automatically slid, the length of the mesh tube 1 becomes long, and the outer diameter thereof becomes small.
  • the mesh tubular stent When the center wire drawing 3 is pulled backward from the outside of the catheter, the mesh tubular stent expands, the length of the mesh tube 1 becomes shorter, and the outer diameter thereof becomes larger, so that the plurality of electrodes can be attached to the blood vessel having a larger diameter;
  • the mesh tubular stent When the center wire 3 is pushed forward from the outside by external force, the mesh tubular stent can be contracted, so that the position of the tubular stent can be moved within the blood vessel or the mesh tubular stent can be withdrawn from the blood vessel, during which the movement can be Avoid damage to the vessel wall by the tubular stent.
  • the center wire drawing 3 is pulled outward by applying a pulling force F2, and the length of the mesh tubular stent is reduced, and the mesh is reduced.
  • Tube 1 direction The outer bulge is in an expanded state; in the process, the electrode 2 moves toward the blood vessel wall, and gradually contacts the blood vessel wall to achieve adherence, and finally contacts the blood vessel wall well.
  • a porous tube 8 is further included, the porous tube 8 is connected to the proximal end of the mesh tubular stent (ie, to the second connecting tube 5); and one end of the central drawing 3 disposed inside the mesh tubular stent is fixed. At the distal end of the mesh tubular stent, the other end passes through the proximal end of the mesh tubular stent and the central bore of the porous tube 8, extending outside the catheter and connected to the control handle.
  • Each of the electrodes 2 is provided with a thermocouple wire 6, a radio frequency wire 7 and a wire, and two ends of the electrode 2 are respectively fixed on the wire of the mesh tube 1, and one end of the thermocouple wire 6 and the RF wire 7 is fixed to the electrode 2 The other end is connected to the external device through a corresponding hole in the porous tube 8. Since the mesh tubular stent has good coverage of blood vessels of different diameters, the same radiofrequency ablation catheter including the above-mentioned mesh tubular stent can be used for radiofrequency ablation of different patients, and the device coverage is good.
  • the mesh tubular stent provided by the invention has good adaptability to the curved blood vessel.
  • the whole body 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.
  • an effect diagram of adhering in a curved blood vessel is not given, but the adaptability of the mesh tubular stent provided by the present invention can be understood in conjunction with the effect diagram of the second embodiment.
  • the shape of the mesh tube and the form after assembly in this embodiment are different from those of the first embodiment.
  • the mesh tube of the tubular tubular bracket is first shaped into a cylindrical shape, and the two ends of the mesh tube are not pre-shrinked, so that when the first connecting tube and the second connecting tube are used, the two ends of the mesh tube are used.
  • the overall shape of the mesh tubular stent 10 assumes a circular shape which is intermediately protruded as shown in FIG. 13 and naturally contracted at both ends.
  • the plurality of electrodes 2 distributed in the middle portion of the mesh tubular stent 10 can be simultaneously attached to the wall by the blood vessel wall. Moreover, since the round-shaped mesh tube is continuously pressed by the blood vessel wall during the expansion process, the adhesion effect of the plurality of electrodes 2 is better.
  • the center wire drawing is also different from the first embodiment. As shown in FIG. 13, one end of the center wire is not fixed to the first connecting pipe, but is passed through the first connecting pipe and is RF. The head end of the ablation catheter is secured together so as to be constrained to the outside of the first connecting tube (ie, the distal end of the mesh tubular support); the other end of the central wire is passed through the interior of the mesh tubular support and is threaded from the center of the second connecting tube Out. Therefore, in this embodiment, the center wire drawing can axially pull the mesh tubular bracket relative to the second connecting pipe, and at the same time, the center wire drawing can Freely sliding toward the distal end of the mesh tubular support relative to the first connecting tube and the second connecting tube.
  • a central puncture needle 11 is further provided in the mesh tubular stent 10, and the central puncture needle 11 protrudes from the surface of the mesh tube when the mesh tubular stent 10 is expanded and attached.
  • a puncture injection is performed; when the mesh tubular stent 10 is contracted, the central puncture needle 11 is contracted inside the mesh tubular stent 10.
  • a similar puncture needle can also be provided in the first embodiment.
  • the configuration of the removal of the mesh tube before assembly and the arrangement of the center wire are different from those of the first embodiment, and the rest of the configuration is the same as that of the first embodiment.
  • the specific structure will not be described in detail here.
  • the flexibility of the mesh tubular stent provided in the second embodiment and the flexibility in the curved blood vessel will be described below only for a specific simulation experiment.
  • FIG. 14a, 14b, 14c, and 14d are respectively experimental results of the stent of the same radiofrequency ablation catheter extending from the sheath tube and extending in the simulated blood vessel with a diameter of 4 mm, 6 mm, 8 mm, and 12 mm;
  • the simulated blood vessel with curvature in Figure 14b It can be seen from Figs. 14a to 14d that the same mesh tubular stent can be well adhered in blood vessels of different diameters, and the adaptability is good, and therefore, the coverage of blood vessels of different diameters is good. Moreover, it can also be seen from Fig. 14b that the tubular stent of the mesh also has good adaptability to curved blood vessels at the same time. Therefore, in actual radiofrequency surgery, the radiofrequency ablation catheter does not have specific requirements for the shape of the vessel at the ablation site, eliminating the limitations of existing radiofrequency ablation catheters.
  • a plurality of electrodes disposed in the middle portion thereof ensure a good adherence during natural expansion, as shown in Fig. 14a.
  • the mesh tubular stent expands within a thicker blood vessel, typically, for example, after natural expansion within a 12 mm diameter vessel as shown in Figure 14d, the mesh tubular stent has an initial lateral diameter that is smaller than the diameter of the blood vessel. Most of the electrodes on the top cannot be attached.
  • the state diagram at this time can be seen in Figure 15a.
  • the mesh tube of the mesh tubular support can reach the attached state as shown in Figure 15b, thus ensuring multiple electrode stickers.
  • the wall is in good condition.
  • FIGS. 14a to 15b are the experimental effect diagrams obtained in the actual simulation experiment, in order to more truly reflect the flexibility of the mesh tubular stent of the radiofrequency ablation catheter provided by the present invention, and the bending of the blood vessel. Adaptability, the applicant provided the actual renderings when submitting the application, but did not make the corresponding line drawing, please ask the examiner to understand.
  • the mesh tubular stent provided by the first embodiment and the second embodiment described above is subjected to shaping treatment of the mesh tube before assembly.
  • the mesh tube is not subjected to a special shaping treatment before being assembled into a mesh tubular support.
  • 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 center wire in the tubular tubular bracket passes through the porous tube and is connected to the control handle, and the control handle can control the advancement, retreat and bending of the radiofrequency ablation catheter.
  • the radio frequency wire and the thermocouple wire in the tubular tubular bracket 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 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 adopts a mesh tube woven by monofilament or multifilament, and a plurality of arrangement forms on the circumferential surface of the mesh tube satisfy the expanded state.
  • the specific requirements of the electrodes allow the electrodes to adhere well when the tubular stent is expanded within blood vessels of different diameters.
  • the tubular stent of the mesh 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 tubular stent of the mesh also has a good coverage of the curved blood vessel at the same time. Capability. 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 nerve ablation procedures of different patients.
  • radio frequency ablation catheter and the device thereof having the mesh tubular 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

一种具有网管状支架结构的射频消融导管及其设备，包括设置在导管前端的网管状支架，网管状支架包括网状管（1）；网状管的两端聚拢构成网管状支架的远端和近端，网管状支架的中间段有收缩状态和扩展状态，网管状支架的中间段上固定有一个或一个以上的电极（2）。射频消融导管中的网管状支架的伸缩性较好，对不同粗细的血管以及弯曲的血管均具有良好的覆盖性。当网状支架在4～12mm粗细不同的血管内扩展时，所有电极（2）均能全部贴壁。同时，当网状支架在弯曲血管内扩展时，也能保证所有电极全部贴壁。

Description

具有网管状支架结构的射频消融导管及其设备 技术领域
本发明涉及一种射频消融导管，尤其涉及一种具有网管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。
背景技术
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。
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。
人体血管的直径因人而异，同时人体内血管直径因为消融部位的不同还具有差别，大部分人体血管直径大约在2～12mm之间，差别较大。现有技术中，单根射频消融导管的电极端的伸缩尺寸通常是固定的，无法适应不同人体的血管的直径尺寸，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，还是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，需要研发一种新的射频消融导管，具有特殊结构的支架，使其具有良好的伸缩率，对不同直径的血管的适应性强，在手术时可以应用于不同直径的血管，并保证多个电极的同时贴壁，从而改善设备的覆盖性。
此外，现有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。
发明内容
本发明所要解决的首要技术问题在于提供一种具有网管状支架结构的射频消融导管，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。
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。
为实现上述的发明目的，本发明采用下述技术方案：
一种具有网管状支架结构的射频消融导管，包括设置在导管前端的网管状支架，所述网管状支架包括网状管；所述网状管的两端聚拢构成所述网管状支架的远端和近端，所述网管状支架的中间段有收缩状态和扩展状态，所述网管状支架的中间段的丝上固定有一个或一个以上的电极。
其中较优地，所述网状管在组装前被定型为中间圆柱、两端收缩状，组装后形态呈圆柱形。
或者，所述网状管在组装前被定型为圆柱形，组装后形态呈中间突出、两端自然收缩的圆鼓形。
其中较优地，还包括穿设于所述电极内部的射频线和热电偶丝；
其中，所述射频线、所述热电偶丝和所述丝分别是独立的丝材；或者，部分丝同时具有所述射频线的功能；或者，所述射频线和所述热电偶丝制作成同一丝材。
其中较优地，多个所述电极的轴向投影在所述网管状支架的轴向上不重叠。
其中较优地，多个所述电极在所述网状管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。
其中较优地，在所述网状管的两端分别设置有第一连接管和第二连接管；
所述网管状支架还包括设置于中心轴上的中心拉丝，所述中心拉丝的一端与设置在所述网管状支架的远端的第一连接管固定或者穿出所述第一连接管并被限制在所述第一连接管的外侧，所述中心拉丝的另一端穿过所述网管状支架的内部并从设置在所述网管状支架近端的 第二连接管的中心穿出；所述中心拉丝可相对于所述第二连接管沿轴向拉动所述网管状支架，并且，所述中心拉丝可以相对于所述第二连接管向所述网管状支架的远端滑移。
其中较优地，所述网管状支架的近端连接有多孔管，所述中心拉丝的一端固定在所述网管状支架的远端或者被限制在所述网管状支架的远端的外侧并可相对于所述网管状支架的远端自由滑移，所述中心拉丝的另一端穿过所述多孔管的中心孔；所述电极内穿热电偶丝、射频线及丝，所述电极的两端分别固定在所述网管状支架上，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。
其中较优地，所述电极的圆周上设置有开口。
其中较优地，所述网状管由单根丝或多根丝编织而成，或者，所述网状管由金属材料或高分子材料加工而成。
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。
本发明提供的具有网管状支架结构的射频消融导管，采用网管状支架安装射频电极，由于网管状支架具有良好的伸缩性，使得当网管状支架在粗细不同的血管内扩展和被拉动后，多个电极均能全部贴壁。并且，通过对设置在网管状支架上的多个电极进行设置，使其在网管状支架的轴向上不重叠，从而不会造成过度消融。该网管状支架的伸缩性较好，对不同直径的血管的覆盖性较好，至少可以满足4～12mm血管的射频消融要求。同时，上述网管状支架对弯曲血管也具有较好的覆盖性。
附图说明
图1是本发明提供的第一实施例中的网管状支架的结构示意图；
图2a是截面为12根丝的圆柱形网状管的结构示意图；
图2b是图2a所示截面为12根丝的圆柱形网状管的截面示意图；
图3a是截面为18根丝的圆柱形网状管的结构示意图；
图3b是图3a所示截面为18根丝的圆柱形网状管的截面示意图；
图4是6个电极的轴向投影在网管状支架的轴向上无重叠分布的示意图；
图5是6个电极的周向投影在网管状支架的圆周截面上均匀分布的示意图；
图6是截面包含12根丝的网状管上安装6个电极的结构示意图；
图7是截面包含18根丝的网状管上安装6个电极的结构示意图；
图8是截面包含24根丝的网状管上安装6个电极的结构示意图；
图9是血管较细时，网管状支架中电极贴壁的动作原理图；
图10是图9所示网管状支架的截面示意图；
图11是血管较粗时，网管状支架中电极贴壁的动作原理图；
图12是第二实施例中，网状管被定型为圆柱形后的结构示意图；
图13是第二实施例中，组装后的圆鼓形网管状支架的结构示意图；
图14a、14b、14c、14d分别是同一个网管状支架在直径为4mm、6mm、8mm、12mm的模拟血管内扩展贴壁后的实验效果图；其中，图14b中的直径为6mm的模拟血管带弧度；
图15a、15b分别是网管状支架在同一较粗模拟血管内自动扩张和经过拉动贴壁后的实验效果图。
具体实施方式
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。
如图1所示，本发明提供的射频消融导管的前端具有网管状支架，网管状支架包括网状管1。网状管1可以由单根丝或多根丝编织而成。网状管1也可以由高分子材料或金属材料加工而成，具体来说，网状管1可以使用高分子材料或者金属材料通过雕刻、机加工、粉末冶金、注塑成型或3D打印等多种加工手段获得。网状管1的形状在组装之前可以定型也可以不定型，网状管1的形状在组装的过程以及扩展的过程中均可以发生变形，组装后，网状管1的两端分别聚拢构成网管状支架的远端和近端，并且，在网状管1聚拢的两端分别设置有连接管4和5；网管状支架的中间段有收缩状态和扩展状态，网状管1中间段(参见图2的A区域)的丝上固定有一个或一个以上的电极2，网状管1的中间段在消融部位的管腔内可以扩展贴壁。为了同时保证网管 状支架的编织密度和伸缩性，网状管1横截面内的丝的数量控制在30根之内为宜。
下面分别以先对网状管1进行定型处理后再组装的两个网管状支架为例，对本发明提供的射频消融导管的网管状支架的结构及其贴壁性进行介绍。其中，第一实施例中，在组装网管状支架前，先将网状管1定型为中间圆柱、两端收缩状，并且，两者之间有一倾斜角度连接，角度可为10°～90°，并进行圆弧过渡(参见图2)；这样在组装后网管状支架的整体形态呈现如1所示的圆柱形。第二实施例中，在组装网管状支架10前，将网状管定型为圆柱形(参见图12)，两端不进行收缩处理，这样在组装的过程中，两端使用连接件收缩后，网管状支架10的整体形态呈现如图13所示的中间突出、两端自然收缩的圆鼓形。下面分别对两个实施例进行详细介绍。
第一实施例
如图2a和图3a所示，第一实施例中，在组装网管状支架前，先将网状管1定型为中间圆柱、两端收缩状(参见图2)。具体来说，在中间圆柱段(区域A)和两端收缩段(ΦB段)之间设置有具有一定倾斜角度的过渡区域，较优地该过渡区域的倾斜角度在10°～90°之间，并且，该过渡区域的两端分别与圆柱段和收缩段通过圆弧过渡，收缩段的直径与消融导管的管径相当；组装时，将网状管1的两端收缩段分别与第一连接管4和第二连接管5固定，这样在组装后网管状支架的整体形态呈现如1所示的圆柱形。
图2a、图2b、图3a和图3b分别是圆柱形网状管1截面内包含12根丝和18根丝的结构示意图。从这两种结构的对比可以看出，当圆柱形网状管1横截面内丝的数量增加时，相邻节点之间丝的长度会适当减小。网管状支架的长度在保证可以在中间段内排列合适数量的电极同时保证其在2～10mm血管内具有足够的伸缩性的基础上，使网管状支架的长度较短为宜。
在该射频消融导管中，还包括穿设于每个电极2内部的热电偶丝6和射频线7。当使用单根丝编织网状管1时，可以使用单根镍钛丝、不锈钢丝或其他丝状材料(例如医用高分子材料)独立编织成支架，并在支架上设置热电偶丝6和射频线7，其中，网丝、射频线7和热 电偶丝6可以分别是独立的丝材，热电偶丝6和射频线7分别和网管状支架缠绕在一起，网丝、射频线7、热电偶丝6各司其职；或者，热电偶丝6和射频线7也可以制作成同一丝材，使射频线7和热电偶丝6一体化，然后和网管状支架缠绕在一起。
当使用多根丝编织网状管1时，可以如上所述，使用多根丝直接编织网状管1，并在网状管1上设置热电偶丝6和射频线7；也可以将其中部分丝(也即用于固定电极2的网丝)用射频线7(或者包括射频线7和热电偶丝6的同一丝材)替代，使部分丝具有射频线功能，并将多根射频线7和剩余的多根丝共同编织形成网状管1。当使用多根射频线7和多根丝共同编织网状管1时，在编织网状管1后，可以将热电偶丝6分别和射频线7缠绕在一起，并多个电极2分别固定在网状管1中的射频线7上。当然，在使用多根丝编织网状管1时，也可以将多根射频线7和多根丝分别缠绕在一起作为一根编织线，并将多根上述编织线与其他丝共同编织形成网状管1。也就是说，该网管状支架中，并不限于由单一丝材编织网状管这一种结构，还可以有其他的结构变形。
在实际制作网管状支架时，每根网丝(或射频线)需要做绝缘处理，可以直接对网丝制作绝缘层，也可以将电极固定在网丝上之后，再对网丝上除去电极的其余部分做绝缘处理。在用于制作网管状支架的每根丝上可以固定一个或多个电极，也可以不设置电极。例如使用12根网丝编织横截面内包括24根丝的网状管时，在其中6根网丝上分别设置一个电极，可以制成具有较高强度的网管状支架，并且，6个电极在网管状支架上的分布不会造成过度消融。又如，可以使用2根网丝编织横截面内包括6根网丝的网状管，在每根网丝上可以分别设置6个电极，从而可以编织成在网状管的外表面上均布12个电极的网管状支架。为了避免多电极对血管壁的过度消融，在设置有多个电极的网管状支架中，多个电极的投影在网管状支架的轴向上最好不重叠。
图4和图5是本发明提供的网管状支架，在网状管1上设置电极的结构示意图，在此以在圆柱形网状管1上设置6个电极为例进行说明，下面的描述中，仅以网状管横截面内的丝的数量作为参数进行描 述，并不考虑具体的编织丝的数目。在本发明提供的网管状支架中，在中间段的圆周面上设置有6个电极2，从图4可以看出，当网管状支架扩展时，6个电极2的轴向投影在网管状支架的轴向上不重叠，从图5可以看出，当网管状支架扩展时，6个电极2的周向投影均匀分布于网管状支架的圆周截面上。虽然在该技术方案中，多个电极的排布形态在网管状支架的圆周面上排列成螺旋形，但是这并不表示多个电极的排布形态需要具有特别的形状，为了保证多个电极的同时贴壁并保证消融效果，多个电极在网管状支架的轴向投影上互不重叠，这样当网管状支架在血管内扩展时，无论血管直径粗细，各个电极都不会造成对血管的过度消融，避免损毁血管。
图6、图7、图8是本发明提供的第一实施例中，当网状管1的横截面内分别包括12根丝、18根丝和24根丝时，在其圆周面上设置6个电极的示意图。将6个电极2在网状管1展开图上的顺序从左上到右下依次标记为#1电极至#6电极。在图6所示的实施例中，6个电极在横截面中包括12根丝的网状管1的圆周面展开图上交错排列成2条直线组成的折线，在图7和图8所示的实施例中，6个电极从左上到右下依次分布在横截面中包括18根丝和24根丝的网状管1的圆周面展开图上，各自排列成一条直线，从而在上述三个实施例中，六个电极在网状管的圆周面上排列成螺旋形。虽然在本申请给出的附图中，6个电极在网管状支架的圆周面上规则排列，但是这并不意味着多个电极必须在网管状支架的圆周面上规则排列，在其他未给出具体结构图的实施例中，多个电极还可以在网状管1的圆周面展开图上无序排列，当然多个电极也可以排列成其他形状。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。在圆鼓形网状管上设置电极的情形与之类似，在第二实施例中对此不再赘述。
如图1所示，本发明提供的网管状支架聚拢的两端分别设置有第一连接管4和第二连接管5，第一连接管4设置在网管状支架的远端，第二连接管5设置在网管状支架的近端。为了将电极2顺利地设置在网状管1的丝上，本发明提供的电极2的中心可以开设圆孔，电极2的圆周上也可以设置开口。当电极2中心设置圆孔时，可以将电极固定在丝上之后再完成网状管的编织，并且，其内部空间较大，在组装 时比较容易将热电偶丝6和射频线7固定在其内部；而在电极2圆周上设置开口，可以方便地将电极2卡在组装好的网状管1上，然后将电极2的两端固定在丝上，完成电极2的设置。电极2的设置方向与丝的延伸方向保持一致，因此，一般不平行于网管状支架的主轴，而与主轴成一定角度倾斜设置；在网管状支架收缩或扩展的过程中，电极2的倾斜角度会发生变化；当网管状支架收缩时，倾斜角度减小，当网管状支架扩展时，倾斜角度增大，并逐渐向竖直方向靠近。
此外，为了控制网管状支架在血管内实现收缩或扩展，在网管状支架内还设置有中心拉丝3。在第一实施例中，中心拉丝3的一端固定在设置于网管状支架远端的第一连接管4内，另一端穿过网管状支架内部然后从设置于网管状支架的近端的第二连接管5内穿出，并且，该中心拉丝3穿过与网管状支架的近端连接的多孔管8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第二连接管5和多孔管8沿轴向拉动网管状支架。当网管状支架在血管内受到血管壁挤压发生收缩变形时，中心拉丝3也可以自动滑移，网状管1的长度变长，其外侧直径变小。当从导管外部向后拉动中心拉丝3时，网管状支架发生扩张，网状管1的长度变短，其外侧直径变大，从而使多个电极可以在直径较粗的血管内实现贴壁；当从外部使用外力向前推送中心拉丝3时，可以使网管状支架收缩，从而可以在血管内移动网管状支架的位置或者将网管状支架从血管内撤出体外，在该移动过程中，可以避免网管状支架对血管壁造成损伤。
下面结合图9、图10和图11对本发明提供的第一实施例中的网管状支架的伸缩性进行介绍。
当闭合的网管状支架从鞘管内伸出后会发生自然扩张，如图1所示，假定网管状支架自然扩张后的初始外侧直径为C mm。如图9和图10所示，当消融血管直径小于C mm时，网管状支架在自然扩张过程中受到血管壁的挤压，呈挤压状态，此时，网状管1的长度变长，其远端向血管内部移动，而各个电极2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C mm时，网管状支架在自然扩张后并未完全接触血管壁，如图11所示，通过施加拉力F2向外部拉动中心拉丝3，网管状支架长度缩小，网状管1向 外膨出，呈扩展状态；在该过程中，电极2向血管壁方向移动，并逐步与血管壁接触实现贴壁，最终与血管壁接触良好。
此外，在该射频消融导管中，还包括多孔管8，多孔管8与网管状支架的近端(即与第二连接管5)连接；在网管状支架的内部设置的中心拉丝3的一端固定在网管状支架的远端，另一端穿过网管状支架的近端和多孔管8的中心孔，延伸到导管外部，与控制手柄连接。在每个电极2内穿设有热电偶丝6、射频线7和丝，电极2的两端分别固定在网状管1的丝上，热电偶丝6和射频线7的一端固定在电极2内，另一端穿过多孔管8上的对应孔与外接设备连接。由于网管状支架对不同直径血管的覆盖性较好，包含上述网管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。
同时，本发明提供的网管状支架对弯曲血管也具有良好的适应性，当上述网管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。在该实施例中，未给出在弯曲血管内贴壁的效果图，但是结合第二实施例的效果图可以对本发明提供的网管状支架的适应性进行了解。
第二实施例
如图12和图13所示，该实施例中网状管的定型形态及组装后的形态与第一实施例不同。在组装前，先将网管状支架的网状管定型为圆柱形，并不对网状管的两端做预先收缩处理，这样当使用第一连接管和第二连接管对网状管的两端组装后，网管状支架10的整体形态呈现图13所示的中间突出、两端自然收缩的圆鼓形。当该网管状支架10在血管内扩展贴壁后，分布在网管状支架10中间段的多个电极2在血管壁的作用下可以同时贴壁。而且，由于圆鼓状的网状管在扩展过程中不断受到血管壁的挤压，所以多个电极2的贴壁效果更好。
在该实施例中，中心拉丝的设置方式也与第一实施例存在区别，如图13所示，中心拉丝的一端并未与第一连接管固定，而是穿出第一连接管后与射频消融导管的头端固定在一起，从而被限制在第一连接管(即网管状支架的远端)的外侧；中心拉丝的另一端穿过网管状支架的内部并从第二连接管的中心穿出。所以，在该实施例中，中心拉丝可相对于第二连接管沿轴向拉动网管状支架，同时，中心拉丝可以 相对于第一连接管和第二连接管向网管状支架的远端自由滑移。
此外，在第二实施例中，如图13所示，在网管状支架10中还设置有中心穿刺针11，中心穿刺针11在网管状支架10扩展贴壁时突出于网状管表面刺入血管壁内，实施穿刺注射；当在网管状支架10收缩时，中心穿刺针11收缩于网管状支架10的内部。当然，在第一实施例中也可以设置类似的穿刺针。
由于第二实施例中，除去网状管在组装前定型的形态以及中心拉丝的设置方式和第一实施例中的网状管形态存在区别之外，其余结构设置和第一实施例相同，因此，在此不再对其具体结构进行详述。下面仅对就具体的模拟实验对第二实施例提供的网管状支架在不同直径的血管内的伸缩性及其在弯曲血管内的伸缩性进行介绍。
图14a、14b、14c、14d分别是同一个射频消融导管的网管状支架从鞘管内伸出后，在直径为4mm、6mm、8mm、12mm的模拟血管内扩展贴壁后的实验效果图；其中，图14b中的模拟血管带弧度。从图14a至14d可以看出，同一个网管状支架在不同直径的血管内均可良好贴壁，适应性较好，因此，对不同直径的血管的覆盖性好。而且，从图14b中还可以看出，该网管状支架同时对弯曲血管也具有良好的适应性。因此，在实际的射频手术中，该射频消融导管对消融部位的血管形状不具有特定要求，消除了现有射频消融导管的局限性。
当网管状支架在较细的血管内扩展时，在自然扩张的过程中，设置在其中间段的多个电极即可确保贴壁良好，如图14a所示。当网管状支架在较粗的血管内扩展时，典型地，例如在图14d所示的直径为12mm的血管内自然扩张后，由于网管状支架的初始外侧直径小于血管的直径，其网状管上的大多数电极均无法贴壁，此时的状态图可参见图15a；通过拉动中心拉丝，网管状支架的网状管可以达到如图15b所示的贴壁状态，从而确保多个电极贴壁状态良好。
在此说明，由于图14a至图15b均是实际模拟实验中所获得的实验效果图，为了更真实地反映本发明所提供的射频消融导管的网管状支架的伸缩性，以及其对弯曲血管的适应性，申请人在提交申请时提供了实际的效果图，而未对其制作对应的线条图，恳请审查员理解。
第三实施例
上述第一实施例和第二实施例提供的网管状支架，在组装之前，均对网状管进行了定型处理。在本发明提供的第三实施例中，网状管在组装成网管状支架前并未做专门的定型处理。当射频消融导管从鞘管内伸出时，网管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的多个电极同时贴壁，并且，在网管状支架扩展贴壁后，多个电极的轴向投影在网管状支架的轴向上不重叠，多个电极的周向投影均匀分布于网管状支架的圆周截面上。
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，网管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。网管状支架中的射频线、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。
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。
综上所述，本发明提供的射频消融导管，由于其采用具有单丝或多丝编织而成的网状管，并且其网状管的圆周面上设置有多个排列形态在扩展状态下满足特定要求的电极，使得当网管状支架在不同直径的血管内扩展时，多个电极均能贴壁良好。该网管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，该网管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神经消融手术具有广泛的覆盖性。
以上对本发明所提供的具有网管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。

Claims (11)

  1. 一种具有网管状支架结构的射频消融导管，其特征在于包括设置在导管前端的网管状支架，所述网管状支架包括网状管；所述网状管的两端聚拢构成所述网管状支架的远端和近端，所述网管状支架的中间段有收缩状态和扩展状态，所述网管状支架的中间段的丝上固定有一个或一个以上的电极。
  2. 如权利要求1所述的射频消融导管，其特征在于：
    所述网状管在组装前被定型为中间圆柱、两端收缩状，组装后呈圆柱形。
  3. 如权利要求1所述的射频消融导管，其特征在于：
    所述网状管在组装前为圆柱形，组装后呈中间突出、两端自然收缩的圆鼓形。
  4. 如权利要求1所述的射频消融导管，其特征在于还包括穿设于所述电极内部的射频线和热电偶丝；
    其中，所述射频线、所述热电偶丝和所述丝分别是独立的丝材；或者，部分丝同时具有所述射频线的功能；或者，所述射频线和所述热电偶丝制作成同一丝材。
  5. 如权利要求1所述的射频消融导管，其特征在于：
    多个所述电极的轴向投影在所述网管状支架的轴向上不重叠。
  6. 如权利要求1所述的射频消融导管，其特征在于：
    多个所述电极在所述网状管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。
  7. 如权利要求1所述的射频消融导管，其特征在于：
    在所述网状管的两端分别设置有第一连接管和第二连接管；
    所述网管状支架还包括设置于中心轴上的中心拉丝，所述中心拉丝的一端与设置在所述网管状支架的远端的第一连接管固定或者穿出所述第一连接管并被限制在所述第一连接管的外侧，所述中心拉丝的另一端穿过所述网管状支架的内部并从设置在所述网管状支架近端的第二连接管的中心穿出；所述中心拉丝可相对于所述第二连接管沿轴向拉动所述网管状支架，并且，所述中心拉丝可以相对于所述第二连 接管向所述网管状支架的远端滑移。
  8. 如权利要求7所述的射频消融导管，其特征在于：
    所述网管状支架的近端连接有多孔管，所述中心拉丝的一端固定在所述网管状支架的远端或者被限制在所述网管状支架的远端的外侧并可相对于所述网管状支架的远端自由滑移，所述中心拉丝的另一端穿过所述多孔管的中心孔；所述电极内穿热电偶丝、射频线及丝，所述电极的两端分别固定在所述网管状支架上，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。
  9. 如权利要求1所述的射频消融导管，其特征在于：
    所述电极的圆周上设置有开口。
  10. 如权利要求1所述的射频消融导管，其特征在于：
    所述网状管由单根丝或多根丝编织而成，或者，所述网状管由金属材料或高分子材料加工而成。
  11. 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。
PCT/CN2015/081584 2014-08-05 2015-06-16 具有网管状支架结构的射频消融导管及其设备 Ceased WO2016019761A1 (zh)

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US16/147,789 US20190029754A1 (en) 2014-08-05 2018-09-30 Catheter apparatus having stabilized interstices, system thereof and methods thereof
US16/218,424 US11883092B2 (en) 2014-08-05 2018-12-12 Radiofrequency ablation catheter apparatus with meshed carrier having stabilized shape, system thereof and methods thereof
US16/574,039 US12064167B2 (en) 2014-08-05 2019-09-17 Method of treating or alleviating erectile dysfunction
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