WO2017132935A1 - 一种多电极肾动脉射频消融导管 - Google Patents

一种多电极肾动脉射频消融导管 Download PDF

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Publication number
WO2017132935A1
WO2017132935A1 PCT/CN2016/073478 CN2016073478W WO2017132935A1 WO 2017132935 A1 WO2017132935 A1 WO 2017132935A1 CN 2016073478 W CN2016073478 W CN 2016073478W WO 2017132935 A1 WO2017132935 A1 WO 2017132935A1
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WO
WIPO (PCT)
Prior art keywords
renal artery
ablation catheter
electrode
artery ablation
carrier member
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/CN2016/073478
Other languages
English (en)
French (fr)
Inventor
汪立
秦杰
盛卫文
王震
朱平
王国辉
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 ANGIOCARE MEDICAL TECHNOLOGY Co Ltd
Terumo Corp
Original Assignee
SHANGHAI ANGIOCARE MEDICAL TECHNOLOGY Co Ltd
Terumo Corp
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 ANGIOCARE MEDICAL TECHNOLOGY Co Ltd, Terumo Corp filed Critical SHANGHAI ANGIOCARE MEDICAL TECHNOLOGY Co Ltd
Priority to PCT/CN2016/073478 priority Critical patent/WO2017132935A1/zh
Priority to CN201620395595.XU priority patent/CN205814415U/zh
Priority to CN201610290782.6A priority patent/CN107028651B/zh
Publication of WO2017132935A1 publication Critical patent/WO2017132935A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • 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 present invention relates to electrosurgery, and more particularly to a multi-electrode renal artery radiofrequency ablation catheter.
  • Refractory hypertension which is still difficult to control with 3 or more drugs (both already using a diuretic) (sBP ⁇ 160mmHg ), it is more common in clinical, its pathogenic factors are numerous, the pathogenesis is not clear, the drug treatment effect is very poor, and the diagnosis and treatment techniques are still not mature enough, which has become one of the major problems in the treatment of hypertension.
  • Radiofrequency ablation of the renal artery is an interventional technique that achieves denervation by delivering a lead through a blood vessel into a specific part of the renal artery, releasing radiofrequency currents and causing local coagulative necrosis of the renal artery.
  • the RF current damage range is small and does not cause harm to the body. Therefore, renal artery radiofrequency ablation has become an effective method for removing renal artery sympathetic nerves.
  • kidney-related diseases especially related diseases caused by excessive activation of renal sympathetic nerves.
  • congestive heart failure CHF
  • renin secretion increases renal vasoconstriction, causing a decrease in renal blood flow.
  • the kidney's response to heart failure can prolong the spiral decline in heart failure conditions.
  • the present invention provides a novel multi-electrode renal artery radiofrequency ablation catheter.
  • the technical problem to be solved by the present invention is to provide a catheter device for regulating renal nerves and treating related diseases with convenient operation, low production cost, and high efficiency.
  • the present invention provides a multi-electrode renal artery ablation catheter
  • An adjustment assembly for modulating a nerve and a delivery member for delivering the adjustment assembly to a location of the nerve;
  • the adjustment assembly includes a plurality of electrodes for delivering modulated energy to the nerve and a carrier member for carrying a plurality of the electrodes;
  • the carrier member has a first shape and a second shape, the adjustment assembly being adapted to move within a blood vessel; and in the second shape, at least one of the electrodes is adapted to adjust the The location at which energy is delivered to the nerve;
  • the multi-electrode renal artery ablation catheter further comprises a sheath; the sheath is sheathed to the delivery member, the sheath being slidable along the delivery member and sheathed or detached from the adjustment assembly;
  • the interior of the multi-electrode renal artery ablation catheter is provided with a guidewire channel extending throughout the multi-electrode renal artery ablation catheter for guiding a guidewire at the multi-electrode renal artery ablation
  • the interior of the catheter moves axially along the multi-electrode renal artery ablation catheter;
  • the multi-electrode renal artery ablation catheter is configured to enable the carrier member to be in the described manner by the separate action of the sheath or the guidewire or by the interaction of the sheath and the guidewire Switching between the first shape and the second shape.
  • the separate function of the sheath means that the carrier member is switched from the second shape to the first shape when the sheath tube slides along the conveying member and is sheathed to the adjustment assembly; The carrier member is switched from the first shape to the second shape when the sheath slides along the transport member and disengages from the adjustment assembly.
  • the guide wire channel has an opening at both the proximal end and the distal end.
  • the separate action of the guide wire means that when the guide wire is inserted into the guide wire passage from the opening of the distal end of the guide wire passage into the interior of the carrier member, The carrier member is switched from the second shape to the first shape; when the guide wire exits from the proximal end opening of the guidewire channel and is withdrawn from the interior of the carrier member, The carrier member is switched from the first shape to the second shape.
  • the interaction of the sheath tube and the guide wire means that the sheath tube slides along the delivery member and is sheathed to the adjustment assembly while the guide wire is from the guide wire channel
  • the load bearing member is switched from the second shape to the first shape when the distal end opening is inserted into the guide wire passage into the interior of the carrier member; when the guide wire is from the guide
  • the proximal end opening of the wire passage exits and pulls away from the carrier member while the sheath slides along the transport member and disengages from the adjustment assembly, the carrier member is switched from the first shape to The second shape.
  • the carrier member and the conveying member are both tubular, and the polymer layer and the NiTi are sequentially arranged from the inside to the outside in the radial direction of the tubular shape.
  • the polymer layer of the carrier member and the polymer layer of the conveying member have a diameter of 0.40 to 0.55 mm, and the thickness is 0.025 ⁇ 0.1 mm.
  • the polymer layer of the carrier member and the polymer layer of the transport member are integrated and formed of a polymer material.
  • the polymer material is PET, FEP, Pebax, PE or PTFE.
  • the surface of the NiTi tube of the bearing member has a cutting pattern, and the cutting pattern is laser-cut on the bearing member.
  • the projection of the spiral groove in a horizontal plane includes a plurality of linear grooves and a plurality of approximate linear grooves.
  • the plurality of linear grooves are located at a distal end of the bearing member, and the plurality of linear grooves comprise a plurality of first linear grooves and a plurality of second linear grooves.
  • each of the two adjacent first linear grooves has the same pitch, and the plurality of the first linear grooves are parallel to each other.
  • each of the two adjacent second linear grooves is the same, and the plurality of the second linear grooves are parallel to each other.
  • an angle between the first linear groove and the axial direction of the bearing member is 75° to 85°
  • the angle between the second linear groove and the axial direction of the bearing member is 65° ⁇ 75°
  • the angle between the approximate linear groove and the axial direction of the bearing member is 50° ⁇ 65°
  • the axial direction refers to a direction from the proximal end of the carrier member to the distal end of the carrier member when the carrier member is in the first shape.
  • the plurality of approximate linear grooves are located at a proximal end of the bearing member, and a distance between two adjacent linear grooves is gradually increased from a distal end to a proximal end of the bearing member.
  • a plurality of said approximate linear grooves are not parallel to each other.
  • the inner insulating layer of the bearing member and the inner insulating layer of the conveying member are both PET heat shrinkable tubes, and the thickness after heat shrinking is 0.012 ⁇ 0.05 mm.
  • the outer insulating layer of the bearing member is a TPU tube or a Pebax tube, and the diameter is 0.9 to 1.2 mm, and the thickness is 0.05 ⁇ 0.15mm.
  • the outer insulating layer of the conveying member is a PET or FEP heat-shrinkable tube, and the thickness after heat shrinking is 0.012 ⁇ 0.1 mm. .
  • the electrode is sleeved on the outside of the outer insulating layer of the carrier member and is reinforced by an adhesive.
  • the binder is a UV curable adhesive or an epoxy resin adhesive.
  • a plurality of said electrodes individually control the release of energy.
  • a plurality of said electrodes simultaneously control the release of energy.
  • each of the electrodes is connected to a wire for providing the electrode with the conditioning energy and monitoring the temperature and impedance at the time of ablation.
  • the wire is disposed between the outer insulating layer and the inner insulating layer of the carrier member and extends between the outer insulating layer and the inner insulating layer of the conveying member.
  • the wire passes through the outer insulating layer of the carrier member and the inner surface of the electrode is soldered or laser welded together.
  • the first shape of the load bearing member is straight or approximately straight.
  • the second shape of the carrier member is spiral or approximately spiral.
  • the spiral shape or the approximate spiral shape has a diameter of 4 to 12 mm and a pitch of 3 to 10 mm.
  • the carrier member is irritating and pre-processed to have the first shape.
  • the electrode has a circular cross section.
  • the number of the electrodes is 2-6, and when the carrier member is in the second shape, the distance between adjacent electrodes is 4 ⁇ 12 mm.
  • the electrode is made of platinum-rhodium alloy or gold.
  • the multi-electrode renal artery ablation catheter further includes a handle for gripping, the handle being coupled to a proximal end of the delivery member, the distal end of the handle being coupled to a proximal end of the delivery member.
  • control mechanism is provided in the handle, and the control mechanism is used to control the movement of the sheath.
  • control mechanism includes a tip, a tooth block and a gear, the end is located at a distal end of the handle and is connected to the sheath, and the tooth block is connected to the end, the gear and The tooth block is matched; rotating the gear enables the tooth block to push and pull the end, such that the tip pushes and pulls the sheath tube along the conveying member.
  • the carrier member and the conveying member are unitary.
  • the proximal end of the carrier member is coupled to the distal end of the delivery member.
  • the sheath has an inner diameter of 1.2 to 1.45 mm and an outer diameter of 1.3 to 1.55 mm.
  • the sheath tube includes an inner layer and an outer layer.
  • the inner layer is made of PTFE and has a wall thickness of 0.015 to 0.5 mm.
  • the outer layer is Pebax or TPU, and the Pebax or TPU contains 20 wt% to 40 wt% BaSO 4 or 10 wt% to 30 wt% BiOCl.
  • the remainder of the outer layer has a braided mesh tube except for the portion of the outer layer that is 1 to 5 mm from the most distal end of the sheath.
  • the braided mesh tube includes a first braided wire segment, a second braided wire segment, and a third braided wire segment.
  • the braided wire of the first braided wire segment, the second braided wire segment and the third braided wire segment is a stainless steel wire or a NiTi wire.
  • the braided wires of the first braided wire segment, the second braided wire segment and the third braided wire segment are differently prepared such that the sheath tube is adjacent to the distal end of the handle 10-20 cm
  • the hardness of the portion is greater than the hardness of the other portions of the sheath.
  • the hardness of the distal end of the sheath has a transition from small to large, facilitating entry of the multi-electrode renal artery ablation catheter into a predetermined location of the renal artery.
  • the distal end of the carrier member is provided with a protective member for reducing or avoiding damage to the blood vessel wall.
  • the protective member is a soft head.
  • the soft head has an opening for the guide wire to be inserted into the carrier member, and the opening of the soft head is an opening at the distal end of the guide wire channel.
  • the protective member is made of rubber, silicone or a thermoplastic elastomer material.
  • the nerve is a renal sympathetic nerve located on a human renal artery, and the 'position close to the nerve' Refers to being located within the renal artery.
  • the regulation refers to the removal or reduction of activation of the nerve by damage or non-injury.
  • the energy is one or more of radio frequency, heat, cooling, electromagnetic energy, ultrasonic wave, microwave or light energy.
  • the blood vessel is a human renal artery.
  • phrase 'suitable for movement in a blood vessel' means that the adjustment assembly does not damage the vessel wall when the adjustment assembly moves within the blood vessel.
  • phrase 'suitable for moving in a blood vessel' means that the maximum dimension of the adjustment assembly in the radial direction of the blood vessel is not greater than the inner diameter of the blood vessel.
  • phrase 'suitable for moving in a blood vessel' means that the maximum dimension of the adjustment component in the radial direction of the blood vessel is not more than 3 mm. .
  • phrase 'suitable for moving in a blood vessel' means that it is easy to bend a segment through a blood vessel.
  • phrase 'suitable for transmitting the modulated energy to the renal nerve' refers to a position at which at least one electrode is in contact with the blood vessel wall when the regulating member is in a blood vessel.
  • the 'location suitable for transferring the modulated energy to the renal nerve' means that the maximum dimension of the adjustment component in the radial direction of the blood vessel is 4-12 mm. At least one of the electrodes is at the largest dimension.
  • the invention is provided with a guide wire channel, and the distal end of the bearing member, that is, the front end of the catheter has an opening, and the guide wire can enter the guide wire passage through the opening during use, which is convenient to operate and conforms to the doctor's usage habits.
  • the load bearing member can provide a sufficient radial support force in a second shape (spiral or approximately spiral) to better approximate the vessel wall.
  • the guide wire and the sheath can work together, that is, after the sheath is disposed, the guide wire can be accurately controlled to move within the guide wire channel, thereby enabling the spiral having a sufficiently large radial support force to be straightened. .
  • the inner wall of the bearing member and the transmission assembly are provided with a polymer layer, thereby avoiding NiTi having a cut pattern The tube will scratch the surface of the guide wire.
  • Each electrode is controlled separately, and the working state of any one electrode is not affected by other electrodes.
  • the medical staff can select one, some or all of the electrodes to release the adjustment energy according to actual needs.
  • the device for regulating nerve provided by the invention is convenient to operate, can simultaneously adjust multiple nerve sites or selectively adjust certain nerve sites, thereby improving work efficiency and further improving treatment accuracy, and In the case of certain electrode failures, the medical staff can flexibly select the working electrode, and greatly submit the handling ability of the unexpected failure of the device to ensure the normal operation of the operation, which has important clinical significance.
  • PTFE refers to polytetrafluoroethylene , ie Polytetrafluoroethylene ;
  • PE means polyethylene, ie Polyethylene
  • FEP refers to a fluorinated ethylene propylene copolymer, namely Fluorinated ethylene propylene
  • TPU refers to thermoplastic polyurethane elastomers, ie Thermoplastic polyurethanes
  • PET refers to polyethylene terephthalate , ie Polyethylene terephthalate ;
  • Pebax refers to ATO Chimie, France
  • the development of a polyether block phthalamide elastomer with a performance between synthetic rubber and thermoplastic polyurethane is known under the trade name Pebax.
  • the end of the device or component that is close to the user (or handle) or away from the nerve site that needs to be adjusted is referred to as the 'distal', and the device or component is remote from the user (or handle) or near.
  • One end of the nerve site that needs to be regulated is called the 'near end'.
  • Figure 1 is a schematic view showing the structure of human kidney and related tissues
  • Figure 2 is a schematic view showing the structure of a human renal artery
  • image 3 Is a schematic diagram of a component of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter provided by the present invention, which shows a first shape of the bearing member;
  • Figure 4 is Figure 3 A schematic view of another state of the illustrated multi-electrode renal artery radiofrequency ablation catheter showing the second shape of the load bearing member;
  • Figure 5 is a cross-sectional view of a carrier member of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention (dissected from the electrode);
  • FIG. 6 is a projection view of a cutting pattern of a load-bearing member of a specific embodiment of the multi-electrode renal artery radiofrequency ablation catheter of the present invention in a horizontal plane;
  • FIG. 7 is an exploded view of a handle of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention.
  • Figure 8 is a partial cross-sectional view of a sheath of a specific embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention.
  • FIG. 9 is a partial cross-sectional view of a sheath of another embodiment of a multi-electrode renal artery radiofrequency ablation catheter of the present invention.
  • Figure 1 Figure 4
  • a preferred embodiment of a multi-electrode renal artery radiofrequency ablation catheter and method of use thereof provided by the present invention is shown, for example, for modulating human renal nerves.
  • FIGs 1 to 2 show the related tissues and structures of human kidney.
  • human kidney-related tissue anatomically includes kidney K
  • kidney K is supplied with oxygen-containing blood through the renal artery RA.
  • the renal artery RA is connected to the heart via the aorta AA of the abdomen.
  • Deoxygenated blood flows from the kidney to the heart via the renal vein RV and the inferior vena cava IVC.
  • figure 2 A more detailed map of the kidney anatomy.
  • the renal anatomy also includes a renal nerve RN extending longitudinally along the axial direction L of the renal artery RA. Renal nerve RN Typically within the outer membrane of the artery.
  • the device is provided for modulating renal nerve RN located on the renal artery RA, said adjustment to remove or reduce renal nerves by injury or non-injury RN Activation.
  • renal nerve RN located on the renal artery RA
  • said adjustment to remove or reduce renal nerves by injury or non-injury RN Activation.
  • nerves at other sites eg, heart-related nerves
  • other modes of adjustment eg, further activation of the nerves is required
  • those skilled in the art can make according to the present invention. Adjustments that are reasonably expected and do not require creative labor.
  • Figures 3 and 4 show the components of a multi-electrode renal artery radiofrequency ablation catheter in this embodiment.
  • the catheter includes an adjustment assembly 100 for modulating the nerve and a delivery member 201 for delivering the adjustment assembly 100 to the nerve.
  • Adjustment component 100 An electrode 101 that delivers modulated energy to the renal nerves and a carrier member 102 for carrying the electrode 101 are included.
  • the carrier member 102 has a first shape (see Fig. 3) and a second shape (see figure) 4), in the first shape, the adjustment assembly 100 is adapted to move in the blood vessel; in the second shape, the at least one electrode 101 is in a position to transfer the modulated energy to the renal nerve.
  • the delivery member 201 is integral with the proximal end of the carrier member 102 coupled to the distal end of the delivery member 201.
  • the electrode 101 The way in which the modulated energy is delivered to the renal nerve site that needs to be modulated is: through the blood vessel into the human body, through the inner wall of the renal artery close to the nerve site. Therefore, the technical problem that needs to be solved is: to achieve the electrode 101 The nerve that acts against the inner wall of the blood vessel acts on the corresponding position, and the electrode 101 is required to easily move in the blood vessel without damaging the blood vessel wall.
  • the multi-electrode renal artery ablation catheter of the present embodiment further includes a sheath tube 301 and a guide wire passage 500 (see Fig. 5).
  • Sheath 301 The jacket is disposed on the conveying member 201.
  • the inner diameter of the sheath 301 is 1.2 to 1.45 mm, and the outer diameter is 1.3 to 1.55 mm.
  • the sheath 301 can be along the conveying member 201. Sliding and jacketing or disengaging the adjustment assembly 100.
  • the guidewire channel 500 is disposed inside the multi-electrode renal artery ablation catheter of the present embodiment and extends through the entire multi-electrode renal artery ablation catheter, i.e., on the carrier member 102.
  • the interior of the inner and delivery member 201 has a portion of the guidewire channel 500.
  • Guide wire channel 500 For axial movement of the guidewire within the multi-electrode renal artery ablation catheter along the multi-electrode renal artery ablation catheter.
  • the guide wire passage 500 has an opening at both the proximal end and the distal end (see Fig. 1).
  • Guide wire channel 500 The distal opening 106 is used to guide the guidewire into the interior of the multi-electrode renal artery ablation catheter, specifically into the interior of the carrier member 102, the guidewire channel 500
  • the proximal opening is used to guide the guidewire out of the multi-electrode renal artery ablation catheter.
  • the distal end of the carrier member 102 is provided with a protective member 105 for reducing or avoiding damage to the vessel wall.
  • Protective member 105 One of the functions is to reduce or avoid damage to the blood vessel wall. When it touches the blood vessel wall, it is soft enough and can rebound quickly without causing loss to the blood vessel; protective member 105 Another function is to guide the entire catheter device. When encountering the bend of the blood vessel, it can bend according to the bending degree of the blood vessel, thereby guiding the entire catheter to smoothly pass through the bend of the blood vessel.
  • the protection component 105 is a soft head made of rubber, silicone or thermoplastic elastomer. The soft head has an opening for guiding the guide wire into the carrier member, which is the opening 106 of the distal end of the guidewire channel 500.
  • the carrier member 102 and the conveying member 201 are both tubular, and are polymer layers, NiTi, in order from the inside to the outside in the radial direction of the tubular shape. Tube, inner insulating layer and outer insulating layer.
  • Figure 5 shows a cross-sectional view of the carrier member 102, which is cut away from the electrode 101, as seen in Figure 5, along the carrier member 102.
  • the radial direction from the inside to the outside is a polymer layer 504, a NiTi tube 503, an inner insulating layer 501, and an outer insulating layer 502.
  • the polymer layer 504 of the carrier member 102 and the conveying member The polymer layer of 201 (not shown) is integrated and has a diameter of 0.40 to 0.55 mm and a thickness of 0.025 to 0.1 mm, both of which are formed of a polymer material, and the polymer material may be PET, FEP, Pebax, PE or PTFE.
  • the carrier member 102 is irritating and pre-processed to have a second shape for the carrier member 102 to be
  • the second shape has a sufficiently large radial supporting force
  • the surface of the NiTi tube 503 of the bearing member 102 is cut by laser cutting to form a cutting pattern.
  • the cutting pattern is a spiral groove
  • Fig. 6 A projected view of the cut pattern in the horizontal plane is shown, with the load bearing member 102 in the first shape.
  • the projection of the spiral groove in the horizontal plane comprises a plurality of linear grooves or a plurality of approximate linear grooves 603,
  • a plurality of linear grooves are located at the distal end of the carrier member 102, and the plurality of linear grooves include a plurality of first linear grooves 601 and a plurality of second linear grooves 602.
  • Two adjacent first linear grooves 601 The pitches are the same, and the plurality of first linear grooves 601 are parallel to each other; the spacing of each adjacent two second linear grooves 602 is the same, and the plurality of second linear grooves 602 are parallel to each other.
  • the inner insulating layer 501 of the carrier member 102 and the inner insulating layer (not shown) of the conveying member 201 are both PET.
  • the heat-shrinkable tube has a thickness of 0.012 to 0.05 mm after heat shrinkage.
  • the outer insulating layer 502 of the bearing member 102 is a TPU tube or a Pebax tube with a diameter of 0.9 to 1.2 mm. The thickness is 0.05 ⁇ 0.15mm.
  • the outer insulating layer (not shown) of the conveying member 201 is a PET or FEP heat-shrinkable tube, and the thickness after heat shrinking is 0.012 ⁇ 0.1 mm. .
  • the electrode 101 is annular and fits over the outer insulating layer 502 of the carrier member 102.
  • the outer surface When the carrier member 102 is in the second shape (inside the renal artery), the electrode 101 on the carrier member 102 It is in contact with the inner wall of the renal artery (near the renal nerve) so that adjustment work can be performed.
  • the outer surface is minimized and the damage to the vessel wall is minimized, and the electrode 101 can be bonded to the outer insulating layer 502 of the carrier member 102 using glue.
  • This type of glue can be UV Curing adhesive, epoxy resin or a mixture thereof has the biocompatibility for medical use and a certain adhesion to metal alloys and polymer materials.
  • an outer insulating layer 502 of the carrier member 102 A wire 505 for providing the electrode 101 with the adjustment energy and monitoring the temperature and impedance during the ablation is provided between the inner insulating layer 501 and the wire 505 at the conveying member 201. The outer insulating layer and the inner insulating layer extend, and the wires 505 in the carrier member 102 and the wires 505 in the conveying member 201 are integrated. Wire 505 passes through the outer insulation of carrier member 102 The inner surface of the 502 and the electrode 101 is welded by soldering or laser welding.
  • the outer insulating layer 502 of the carrier member 102 has an opening (not shown) at a position where the electrode 101 is attached.
  • a wire 505 connected to an energy generating device e.g., a radio frequency meter
  • the wire 505 is welded to the inner surface of the electrode 101 through the opening.
  • Each of the electrodes 101 operates independently and has a separate wire 505, respectively. Whether an electrode releases the adjustment energy is independent of other electrodes; only one or a part of the electrodes can transmit the adjustment energy, or all the electrodes can work at the same time to transmit the adjustment energy; the state of whether each electrode transmits the adjustment energy is independent of each other.
  • Elements for measuring temperature e.g., thermocouples
  • corresponding wires may also be disposed on the carrier member 102. The arrangement of the wires and thermocouples is conventional in the art and will not be described in detail herein.
  • the carrier member 102 The first shape is straight or nearly straight, and may also be elongated or fibrous or filiform.
  • the cross section of the strip is preferably circular or nearly circular, and the widest part of the cross section is smaller than the inside of the blood vessel. diameter.
  • the adjustment assembly 100 does not damage the vessel wall as it moves through the blood vessel.
  • the adjustment component 100 The maximum dimension in the radial direction of the renal artery is not more than 4 mm, preferably 1-2 mm.
  • the first shape may also allow for a certain bending or wavy bending, and the cross section may be other shapes as long as the surface is smooth and can be easily moved within the blood vessel without damaging the blood vessel wall. can.
  • the second shape of the carrier member 102 is entirely spiral or approximately spiral, and the bearing member 102 is radially in the blood vessel.
  • the widest point is larger than the first shape so that the loaded electrode 101 is brought close to or in contact with the vessel wall, thereby being close to the renal nerve.
  • the diameter of the spiral or approximate spiral of the bearing member 102 is set to 4 to 12 mm, and the pitch is 3 ⁇ 10 mm.
  • the diameter of the spiral or approximately spiral of the bearing member 102 can be set to 5 to 6 mm.
  • the diameter of the spiral or approximate spiral can be set to about 8 to 9 mm.
  • the second shape of the carrier member 102 can also be other shapes, such as a random shape having a smooth curvature, as long as the carrier member 102 When in the blood vessel, the electrode 101 is in a position to contact the blood vessel wall.
  • the multi-electrode renal artery radiofrequency ablation catheter of the present embodiment causes the carrier member 102 by the interaction of the sheath 301 and the guide wire.
  • Switching between the first shape and the second shape i.e., when the sheath 301 slides along the delivery member 201 and overlies the adjustment assembly 100, while guiding the guidewire from the distal end of the guidewire channel 500 106
  • the carrier member 102 is switched from the second shape to the first shape; when the guidewire is from the proximal end of the guidewire channel 500.
  • the carrier member 102 is worn out and withdrawn from the interior of the carrier member 102 while the sheath tube 301 slides along the delivery member 201 and disengages from the adjustment assembly 100. Switching from the first shape to the second shape.
  • the sheath 301 may be passed through. Or the separate action of the guide wire effects the switching of the carrier member 102 between the first shape and the second shape.
  • the separate function of the sheath 301 means that the sheath 301 slides along the conveying member 201 and is sheathed to the adjustment assembly. At 100 o'clock, the carrier member 102 is switched from the second shape to the first shape; when the sheath 301 slides along the transport member 201 and disengages from the adjustment assembly 100, the carrier member 102 Switching from the first shape to the second shape.
  • the separate action of the guidewire means that the guidewire enters the carrier member 102 as it is inserted into the guidewire channel 500 from the opening 106 from the distal end of the guidewire channel 500.
  • the carrier member 102 is switched from the second shape to the first shape; when the guide wire passes through the opening 107 at the proximal end of the guide wire passage 500 and is pulled away from the inside of the carrier member 102, the carrier member 102 switches from the first shape to the second shape.
  • the carrier member 102 From the first shape to the second shape, at this time, the electrode 101 on the carrier member 102 abuts against the inner wall of the blood vessel to act on the nerve at the corresponding position, releasing energy. Certain energy acts on the nerve site to regulate the nerve site (eg, reduce or eliminate activation of the sympathetic nerve);
  • Electrode 101 This can be achieved by transferring heat to the nerve site.
  • heat transfer heating mechanisms for neuromodulation may include thermal ablation and non-ablative thermal changes or damage, for example, the temperature of the target nerve fibers may be raised above a desired threshold to achieve non-ablative thermal changes, or more High temperatures to achieve thermal changes in ablation.
  • the target temperature can be around 37 ° C - 45 ° C (for the thermal temperature of non-thermal ablation), or the target temperature may be about 45 ° C or higher for the thermal change of ablation.
  • Electrode 101 can also accomplish this by delivering cooling to the nerve site. For example, reducing the temperature of the target nerve fiber to about 20 Below °C to achieve non-freezing thermal changes, or to lower the temperature of the target nerve fibers to below about 0 °C to achieve the thermal change of freezing.
  • Electrode 101 It can also be achieved by applying an energy field to the target nerve fibers.
  • the energy field may include: electromagnetic energy, radio frequency, ultrasonic waves (including high intensity focused ultrasound), microwave, light energy (including laser, infrared, and near infrared).
  • thermally induced neuromodulation can be achieved by delivering a pulsed or continuous thermal energy field to the target nerve fibers.
  • a more preferred energy mode is a pulsed RF electric field or other types of pulsed thermal energy. Pulsed RF electric fields or other types of pulsed thermal energy can contribute to greater heat levels, longer total duration, and / or better controlled intravascular renal neuromodulation therapy.
  • the electrode 101 Need to generate this energy (such as a radio frequency meter) or to make an electrode 101
  • the device that generates the energy itself is electrically connected.
  • the number of the electrodes 101 is four. Adjacent electrodes when the carrier member 102 is in the second shape (helical) 101 The distance D in the axial direction of the blood vessel is 4 ⁇ 12 mm. In general, when performing renal nerve ablation surgery, 3-8 of the renal nerves One site is ablated. Therefore, when working with the apparatus of this embodiment, the positioning of the primary adjustment assembly 100 (contacting the electrode 101 to the inner wall of the blood vessel) can be completed. Ablation of the sites, and the entire ablation procedure requires only two adjustments to the positioning of the assembly 100. As a variation of this embodiment, the number of electrodes 101 can also be set to 2 ⁇ 6.
  • Electrode 101 The material may be a metal or metal alloy that is more biocompatible or relatively stable, such as a platinum group metal (such as a platinum rhodium alloy).
  • the guide wire of this embodiment is a wire made of a NiTi alloy.
  • the multi-electrode renal artery radiofrequency ablation catheter of the present embodiment further includes a handle 401 for gripping, a distal end of the handle 401 and a delivery member The proximal connection of 201 (see Figure 3).
  • the wire 505 is connected to the handle 401 after extending within the carrier member 102 and the conveying member 201.
  • Handle 401 The connecting cable to the external energy generator is provided as a separate unit or a separate two parts connected by a switching port.
  • the movement of the sheath 301 of the present embodiment is controlled by a control mechanism 7 provided in the handle 401, see 3 and FIG. 7, the control mechanism 7 includes a tip 701, a tooth block 702 and a gear 703.
  • the end 701 is located at the distal end of the handle 401 and is coupled to the sheath 301.
  • the tooth block 702 Connected to the end 701, the gear 703 is matched with the tooth block 702; the rotating gear 703 enables the tooth block 702 to push and pull the end 701 so that the end 701 pushes and pulls the sheath 301 Move along the conveying member 201.
  • the material of the sheath 301 is a polymer material such as Pebax or TPU, which is slightly harder than the material of the bearing member 102 and has a hardness of 50A-50D.
  • the sheath 301 includes an inner layer 302 and an outer layer 303.
  • the inner layer 302 is made of PTFE, has a wall thickness of 0.015-0.5 mm, and has a small coefficient of friction.
  • the outer layer 303 is made of Pebax or TPU and may contain 20 wt% to 40 wt% BaSO 4 or 10 wt% to 30 wt% BiOCl.
  • the remainder of the outer layer has a braided mesh tube, except for the outer layer 1 to 5 mm from the farthest end of the sheath 301, as shown in Fig. 9.
  • the braided mesh tube includes a first braided wire segment 313, a second braided wire segment 323, and a third braided wire segment 333; a first braided wire segment 313, a second braided wire segment 323, and a third braided wire segment 333
  • the braided wire is a stainless steel wire or a Ni-Ti wire.
  • first braided wire segment 313, a second braided wire segment 323 and a third braided wire segment 333 Different hardnesses can be achieved by the same weaving method and the different hardness of Pebax in the outer layer in which they are located, or by the same Pebax hardness and different weaving methods.
  • the braided wires of the first braided wire segment 313, the second braided wire segment 323 and the third braided wire segment 333 are made in a different manner, so that the sheath 301 is close to the distal end of the 401 handle 10-20 cm.
  • the hardness of the portion is greater than the hardness of the other portions of the sheath 301.
  • the hardness of the distal end of the sheath 301 has a transition from small to large, facilitating the multi-electrode renal artery ablation catheter of the present embodiment to enter a predetermined position of the renal artery.

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Abstract

一种多电极肾动脉消融导管，包括用于调节神经的调节组件（100）、用于将调节组件（100）输送到神经的位置的输送部件（201）、鞘管（301）。调节组件（100）包括用于将调节能量传递到神经的多个电极（101）和用于承载多个电极（101）的承载部件（102）；承载部件（102）具有第一形状和第二形状，在第一形状下，调节组件（100）适于在血管中移动；在第二形状下，至少一个电极（101）处于适合将调节能量传递到神经的位置。鞘管（301）外套于输送部件（201），能够沿输送部件（201）滑动并外套于或脱离调节组件（100）。多电极肾动脉消融导管的内部设置有导丝通道（500），且该导丝通道（500）贯穿整个多电极肾动脉消融导管。通过鞘管（301）或导引导丝的单独作用或通过鞘管（301）和导引导丝的共同作用能够使承载部件（102）在第一形状和第二形状之间切换。

Description

一种多电极肾动脉射频消融导管
技术领域
本发明涉及电外科，尤其涉及一种多电极肾动脉射频消融导管。
背景技术
顽固性高血压，即使用 3 种或以上药物（都已经使用一个利尿剂）仍然难以控制的高血压（ sBP≥160mmHg ），在临床上较常见，其致病因素众多，发病机制不明确，药物治疗效果很差，诊断和治疗技术仍不够成熟，成为高血压治疗的重大难题之一。
最新的动物及临床实验数据证明对肾神经的调节（例如去交感神经）可以显著持久地减低顽固性高血压，例如最近发展出的肾动脉射频消融术。肾动脉射频消融术是一种通过将电极导管经血管送入肾动脉内特定部位，释放射频电流导致肾动脉交感神经局部凝固性坏死，达到去神经的介入性技术。射频电流损伤范围小，不会造成机体危害，因此肾动脉射频消融术已经成为一种有效的去除肾动脉交感神经的方法。
另外，对肾神经的调节被证明对多种与肾脏相关的疾病有一定效果，特别是肾交感神经过度活化导致的相关疾病。例如，充血性心力衰竭（ CHF ）可以导致异常高的肾交感神经活化，从而导致从身体除去的水和钠的减少，并增加肾素的分泌。增加的肾素分泌导致肾血管收缩，引起肾血流量的降低。从而，肾对于心力衰竭的反应可以使心力衰竭病症的螺旋下降延长。
尽管相关文献或专利中有报道用于调节肾动脉交感神经的相关器械，但目前现有的器械具有操作不便、制作成本高或效率低下等缺陷，比如电极承载部件不能提供足够大的支撑力、电极承载部件切割部位摩擦力较大等。
因此，本发明提供一种新型的多电极肾动脉射频消融导管。
发明内容
有鉴于现有技术的上述缺陷，本发明所要解决的技术问题是提供一种操作便利、制作成本低、效率高的用于调节肾神经而治疗相关疾病的导管装置。
为实现上述目的，本发明提供了一种多电极肾动脉消融导管，
包括用于调节神经的调节组件和用于将所述调节组件输送到所述神经的位置的输送部件；
所述调节组件包括用于将调节能量传递到所述神经的多个电极和用于承载多个所述电极的承载部件；
所述承载部件具有第一形状和第二形状，在所述第一形状下，所述调节组件适于在血管中移动；在所述第二形状下，至少一个所述电极处于适合将所述调节能量传递到所述神经的位置；
其特征在于，所述多电极肾动脉消融导管还包括鞘管；所述鞘管外套于所述输送部件，所述鞘管能够沿所述输送部件滑动并外套于或脱离所述调节组件；
所述多电极肾动脉消融导管的内部设置有导丝通道，所述导丝通道贯穿整个所述多电极肾动脉消融导管，所述导丝通道用于导引导丝在所述多电极肾动脉消融导管的内部沿所述多电极肾动脉消融导管的轴向移动；
所述多电极肾动脉消融导管被配置为：通过所述鞘管或所述导引导丝的单独作用或通过所述鞘管和所述导引导丝的共同作用能够使所述承载部件在所述第一形状和所述第二形状之间切换。
进一步地，所述鞘管的单独作用是指当所述鞘管沿所述输送部件滑动并外套于所述调节组件时，所述承载部件由所述第二形状切换为所述第一形状；当所述鞘管沿所述输送部件滑动并脱离所述调节组件时，所述承载部件由所述第一形状切换为所述第二形状。
进一步地，所述导丝通道的近端和远端均具有开口。
进一步地，所述导引导丝的单独作用是指当所述导引导丝从所述导丝通道的所述远端的开口插入所述导丝通道而进入所述承载部件的内部时，所述承载部件由所述第二形状切换为所述第一形状；当所述导引导丝从所述导丝通道的所述近端的开口穿出并抽离所述承载部件的内部时，所述承载部件由所述第一形状切换为所述第二形状。
进一步地，所述鞘管和所述导引导丝的共同作用是指当所述鞘管沿所述输送部件滑动并外套于所述调节组件，同时所述导引导丝从所述导丝通道的所述远端的开口插入所述导丝通道而进入所述承载部件的内部时，所述承载部件由所述第二形状切换为所述第一形状；当所述导引导丝从所述导丝通道的所述近端的开口穿出并抽离所述承载部件，同时所述鞘管沿所述输送部件滑动并脱离所述调节组件时，所述承载部件由所述第一形状切换为所述第二形状。
进一步地，所述承载部件与所述输送部件均为管状，且沿所述管状的径向由内向外依次为高分子层、 NiTi 管、内绝缘层和外绝缘层。
进一步地，所述承载部件的高分子层和所述输送部件的高分子层的直径均为 0.40~0.55 mm ，厚度均为 0.025~0.1 mm 。
进一步地，所述承载部件的高分子层和所述输送部件的高分子层为一体的，由高分子材料形成。
进一步地，所述高分子材料为 PET 、 FEP 、 Pebax 、 PE 或 PTFE 。
进一步地，所述承载部件的 NiTi 管的表面具有切割花纹，所述切割花纹为通过激光切割在所述承载部件的 NiTi 管的表面形成的螺旋线槽。
进一步地，当所述承载部件处于所述第一形状时，所述螺旋线槽在水平面的投影包括多个直线槽和多个近似直线槽。
进一步地，所述多个直线槽位于所述承载部件的远端，所述多个直线槽包括多个第一直线槽和多个第二直线槽。
进一步地，每相邻两个所述第一直线槽的间距相同，多个所述第一直线槽之间互相平行。
进一步地，每相邻两个所述第二直线槽的间距相同，多个所述第二直线槽彼此之间互相平行。
进一步地，所述第一直线槽与所述承载部件的轴向的夹角为 75°~85° ，所述第二直线槽与所述承载部件的轴向的夹角为 65°~75° ，所述近似直线槽与所述承载部件的轴向的夹角为 50°~65° ，所述轴向是指当所述承载部件处于所述第一形状时，从所述承载部件的近端指向所述承载部件的远端的方向。
进一步地，所述多个近似直线槽位于所述承载部件的近端，从所述承载部件的远端至近端，相邻两个所述近似直线槽之间的间距是逐渐增大的，多个所述近似直线槽彼此之间互不平行。
进一步地，所述承载部件的内绝缘层和所述输送部件的内绝缘层均为 PET 热缩管，热缩后的厚度为 0.012~0.05 mm 。
进一步地，所述承载部件的外绝缘层为 TPU 管或 Pebax 管，直径为 0.9~1.2mm ，厚度为 0.05~0.15mm 。
进一步地，所述输送部件的外绝缘层为 PET 或 FEP 热缩管，热缩后 的厚度 0.012~0.1 mm 。
进一步地，所述电极套合于所述承载部件的外层绝缘层的外部，并通过粘结剂加强固定。
进一步地，所述粘结剂为 UV 固化胶或环氧树脂胶。
进一步地，多个所述电极单独控制释放能量。
进一步地，多个所述电极同时控制释放能量。
进一步地，每个所述电极的内表面与导线相连，所述导线用于为所述电极提供所述调节能量和监控消融时的温度和阻抗。
进一步地，所述导线设置于所述承载部件的外绝缘层和内绝缘层之间，并在所述输送部件的外绝缘层和内绝缘层之间延伸。
进一步地，所述导线穿过所述承载部件的外绝缘层与所述电极的内表面通过锡焊或激光焊接在一起。
进一步地，所述承载部件的所述第一形状为直的或近似直的。
进一步地，所述承载部件的所述第二形状为螺旋形或近似螺旋形。
进一步地，所述螺旋形或所述近似螺旋形的直径为 4~12 mm 、螺距为 3~10mm 。
进一步地，所述承载部件为扰性的，且被预处理为具有所述第一形状。
进一步地，所述电极的横截面为环形。
进一步地，所述电极的数目为 2~6 个，当所述承载部件处于所述第二形状时，相邻的所述电极之间的距离为 4~12 mm 。
进一步地，所述电极采用铂铱合金材质或黄金材质。
进一步地，所述多电极肾动脉消融导管还包括用于握持的手柄，所述手柄与所述输送部件的近端连接，所述手柄的远端与所述输送部件的近端连接。
进一步地，所述手柄内设置有控制机构，所述控制机构用于控制所述鞘管的移动。
进一步地，所述控制机构包括端头、齿块和齿轮，所述端头位于所述手柄的远端并与所述鞘管连接，所述齿块与所述端头连接，所述齿轮与所述齿块匹配；转动所述齿轮能够使所述齿块推拉所述端头，从而所述端头推拉所述鞘管沿所述输送部件移动。
进一步地，所述承载部件和所述输送部件是一体的。
进一步地，所述承载部件的近端与所述输送部件的远端相连。
进一步地，所述鞘管的内径为 1.2~1.45 mm ，外径为 1.3~1.55 mm 。
进一步地，所述鞘管包括内层和外层。
进一步地，所述内层的材质为 PTFE ，壁厚为 0.015~0.5 mm 。
进一步地，所述外层为 Pebax 或 TPU ，所述 Pebax 或 TPU 中含有 20 wt% ~ 40wt%BaSO4 或 10 wt% ~30 wt% 的 BiOCl 。
进一步地，除所述外层距离所述鞘管的最远端 1~5 mm 的部分外，所述外层的其余部分具有编织网管。
进一步地，所述编织网管包括第一编织丝段、第二编织丝段和第三编织丝段。
进一步地，所述第一编织丝段、所述第二编织丝段和所述第三编织丝段的编制丝为不锈钢丝或 NiTi 丝。
进一步地，所述第一编织丝段、所述第二编织丝段和所述第三编织丝段的编织丝的编制方式不同，使所述鞘管靠近所述手柄的远端 10~20 cm 的部分的硬度大于所述鞘管的其它部分的硬度。
进一步地，所述鞘管的远端的硬度具有从小到大的过渡，便于所述多电极肾动脉消融导管进入肾动脉预定位置。
进一步地，所述承载部件的远端设置有用于减少或避免血管壁损伤的保护部件。
进一步地，所述保护部件为软头。
进一步地，所述软头具有用于所述导引导丝插入所述承载部件的开口，所述软头的开口为所述导丝通道远端的开口。
进一步地，所述保护部件由橡胶、硅胶或热塑性弹性体材料制成。
进一步地，所述的神经为位于人肾动脉上的肾交感神经，所述的 ' 靠近所述神经的位置 ' 指的是位于所述肾动脉内。
进一步地，所述调节是指通过损伤或非损伤的方式除去或降低所述神经的活化。
进一步地，所述的能量为射频、热量、冷却、电磁能、超声波、微波或光能中一种或几种。
进一步地，所述的血管为人肾动脉。
进一步地，所述的'适合在血管中移动'指的是当所述调节组件在血管中移动时，所述调节组件不损伤血管壁。
进一步地，所述的'适合在血管中移动'指的是所述调节组件在所述血管的径向上的最大尺寸不大于所述血管的内径。
进一步地，所述的'适合在血管中移动'指的是所述调节组件在所述血管的径向上的最大尺寸不大于 3mm 。
进一步地，所述的'适合在血管中移动'是指易于通过血管弯曲段。
进一步地，所述的'适合将所述调节能量传递到所述肾神经的位置'指的是当所述调节部件在血管中时，至少一个电极处于接触血管壁的位置。
进一步地，所述的'适合将所述调节能量传递到所述肾神经的位置'指的是所述调节组件在所述血管的径向上的最大尺寸为 4-12mm ，至少一个电极处于最大尺寸处。
与现有的导管装置相比，本发明的多电极肾动脉射频消融导管具有以下优点：
（ 1 ）本发明设置有导丝通道，且承载部件的远端即导管前端具有开口，使用时导引导丝能够通过该开口进入导丝通道，操作便利，符合医生的使用习惯。
（ 2 ）通过设计独特的切割花纹，并包覆绝缘层，使承载部件处于第二形状（螺旋形或近似螺旋形）时能够提供足够大的径向支撑力，从而更好地贴近血管壁。
（ 3 ）使用过程中，导引导丝和鞘管能够共同作用，即设置鞘管后，能够精确地控制导引导丝在导丝通道内移动，从而能够使具有足够大的径向支撑力的螺旋变直。
（ 4 ）承载部件和传输组件的内壁均设置有高分子层，从而可以避免具有切割花纹的 NiTi 管会刮掉导引导丝表面涂层的问题。
（ 5 ） 每个电极单独控制，任何一个电极的工作状态都不受其他电极的影响，医务人员可以根据实际需要，选择一个、部分或全部电极释放调节能量。本发明所提供的用于调节神经的装置操作便利，能够同时对多个神经位点进行调节或者对某些神经位点进行选择性调节，从而提高工作效率，并进一步提高治疗的准确度，并且在某些电极故障的情况下，医务人员可以灵活的选择工作电极，大大提交了设备意外故障的处理能力，保障手术的正常进行，具有重要的临床意义。
本发明中，用到的缩写：
PTFE 指聚四氟乙烯 , 即 Polytetrafluoroethylene ；
PE 是指聚乙烯，即 Polyethylene ；
FEP 指氟化乙烯丙烯共聚物，即 Fluorinated ethylene propylene ；
TPU 指热塑性聚氨酯弹性体，即 Thermoplastic polyurethanes ；
PET 指 聚对苯二甲酸乙二醇酯 ，即 Polyethylene terephthalate ；
Pebax 指 法国阿托化学公司 (ATO Chimie) 发展的性能介于合成橡胶和热塑性聚氨醋之间的聚醚嵌段酞胺弹性体，其牌号称为 Pebax 。
为了便于说明，本发明中将装置或部件的靠近使用者（或手柄）或远离需要调节的神经位点的一端称为'远端'，将装置或部件的远离使用者（或手柄）或靠近需要调节的神经位点的一端称为'近端'。
以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明，以充分地了解本发明的目的、特征和效果。
附图说明
图 1 是人肾及相关组织的结构示意图；
图 2 是人肾动脉的结构示意图；
图 3 是本发明提供的多电极肾动脉射频消融导管的一种具体实施方式的组成部分示意图，该图示出了承载部件的第一形状；
图 4 是图 3 所示的多电极肾动脉射频消融导管的另一种状态的示意图，该图示出了承载部件的第二形状；
图 5 为本发明的多电极肾动脉射频消融导管的一种具体实施方式的承载部件的截面图（从电极处剖开）；
图 6 是本发明的多电极肾动脉射频消融导管的一种具体实施方式的承载部件的切割花纹在水平面的投影图；
图 7 是本发明的多电极肾动脉射频消融导管的一种具体实施方式的手柄的分解图；
图 8 是本发明的多电极肾动脉射频消融导管的一种具体实施方式的鞘管的局部剖面图；
图 9 是本发明的多电极肾动脉射频消融导管的另一种具体实施方式的鞘管的局部剖面图。
具体实施方式
图 1~ 图 4 示出了本发明所提供的多电极肾动脉射频消融导管及其使用方法的一种优选的具体实施方式，该具体实施方式以用于调节人肾神经为例。
图 1~ 图 2 示出了 人肾的相关组织和结构。如图 1 所示，人肾相关组织在解剖学上包括肾 K ，肾 K 通过肾动脉 RA 被供给含氧的血液。肾动脉 RA 经由腹部的主动脉 AA 连接到心脏。脱氧的血液经由肾静脉 RV 和下腔静脉 IVC 从肾流到心脏。图 2 更详细地图解肾解剖学的一部分。更具体而言，肾解剖学也包括沿着肾动脉 RA 的轴向 L 纵向延伸的肾神经 RN 。肾神经 RN 一般在所述动脉的外膜内。在该具体实施方式中，所提供的装置用于调节位于肾动脉 RA 上的肾神经 RN ，所述的调节是指通过损伤或非损伤的方式除去或降低肾神经 RN 的活化。作为该具体实施方式的变化，如果需要调节其它部位的神经（例如，心脏相关神经），或者需要其它的调节方式（例如，需要更进一步提高神经的活化），本领域技术人员可以根据本发明做出可合理预期的、不需要付诸创造性劳动的调整。
图 3 和图 4 示出了该具体实施方式中的多电极肾动脉射频消融导管的组成部分。如图 3~ 图 4 所示，该导管包括用于调节神经的 调节组件 100 以及将调节组件 100 输送到神经的位置的输送部件 201 。调节组件 100 包括将调节能量传递到肾神经的电极 101 以及用于承载电极 101 的承载部件 102 。 承载部件 102 具有第一形状（参见图 3 ）和第二形状（参见图 4 ），在第一形状下，调节组件 100 用于在血管中移动；在第二形状下，至少一个电极 101 处于将调节能量传递到肾神经的位置 。本实施例中，承载部件 102 和输送部件 201 是一体的，承载部件 102 的近端与输送部件 201 的远端相连。
本实施例中，电极 101 传递调节能量给需要调节的肾神经位点的方式为：经由血管进入人体，通过肾动脉内壁靠近神经位点。因此需要解决的技术问题是：既要实现电极 101 能够紧贴血管内壁作用于相应位置的神经，又需要电极 101 在血管中方便地移动，不损伤血管壁。
本实施例的多电极肾动脉消融导管还包括 鞘管 301 和导丝通道 500 （参见图 5 ）。鞘管 301 外套于输送部件 201 ， 鞘管 301 的内径为 1.2~1.45 mm ，外径为 1.3~1.55 mm ， 鞘管 301 能够沿输送部件 201 滑动并外套于或脱离所述调节组件 100 。导丝通道 500 设置在本实施例的多电极肾动脉消融导管的内部，并贯穿整个多电极肾动脉消融导管，即在承载部件 102 的内部和输送部件 201 的内部具有导丝通道 500 的一部分。 导丝通道 500 用于导引导丝在多电极肾动脉消融导管的内部沿多电极肾动脉消融导管的轴向移动。导丝通道 500 的近端和远端均具有开口（参见图 1 ）。导丝通道 500 的远端的开口 106 用于导引导丝穿入多电极肾动脉消融导管的内部，确切地说是穿入承载部件 102 的内部，导丝通道 500 的近端的开口用于导引导丝从多电极肾动脉消融导管穿出。
承载部件 102 的远端设置有用于减少或避免血管壁损伤的保护部件 105 。保护部件 105 的一个作用是减少或避免血管壁损伤，碰触到血管壁时，因为自身足够柔软且能够迅速回弹，不会对血管造成损失；保护部件 105 的另一个作用是对整个导管装置起到导向作用，当遇到血管的弯折处时，自身能够根据血管的弯折度弯曲，从而引导整个导管顺利通过血管的弯折处。本实施例中，保护部件 105 为软头，由橡胶、硅胶或热塑性弹性体材料制成。该软头具有用于导引导丝插入承载部件的开口，该开口即为导丝通道 500 的远端的开口 106 。
承载部件 102 与输送部件 201 均为管状，且沿该管状的径向由内向外依次为高分子层、 NiTi 管、内绝缘层和外绝缘层。图 5 示出了 承载部件 102 的剖面图，该剖面图为从电极 101 处剖开，从图 5 中看出，沿承载部件 102 的径向由内向外依次为 高分子层 504 、 NiTi 管 503 、内绝缘层 501 和外绝缘层 502 。 承载部件 102 的高分子层 504 和输送部件 201 的高分子层（未示出）是一体的，且 直径均为 0.40~0.55 mm ，厚度均为 0.025~0.1 mm ， 均由高分子材料形成，高分子材料可以为 PET 、 FEP 、 Pebax 、 PE 或 PTFE 。
承载部件 102 为扰性的，且被预处理为具有第二形状，为了使承载部件 102 处于第二形状时具有足够大的径向支撑力，承载部件 102 的 NiTi 管 503 的表面通过 激光 切割在形成切割花纹，本实施例中该切割花纹为螺旋线槽，图 6 示出了该切割花纹在水平面的投影图，图中为承载部件 102 处于第一形状时。该螺旋线槽在水平面的投影包括多个直线槽或多个近似直线槽 603 ， 多个直线槽位于承载部件 102 的远端，多个直线槽包括多个第一直线槽 601 和多个第二直线槽 602 。每相邻两个第一直线槽 601 的间距相同，多个第一直线槽 601 之间互相平行；每相邻两个第二直线槽 602 的间距相同，多个第二直线槽 602 彼此之间互相平行。多个近似直线槽 603 位于承载部件 102 的近端，从承载部件 102 的远端至近端，相邻两个近似直线槽 603 之间的间距是逐渐增大的，多个近似直线槽 603 彼此之间互不平行。第一直线槽 601 与承载部件 102 的轴向的夹角为 75°~85° ，第二直线槽 602 与承载部件 102 的轴向的夹角为 65°~75° ，近似直线槽 603 与承载部件 102 的轴向的夹角为 50°~65° ，此处的轴向是指当承载部件 102 处于第一形状时，从承载部件 102 的近端指向承载部件 102 的远端的方向。
本实施例中，承载部件 102 的内绝缘层 501 和输送部件 201 的内绝缘层（未示出）均为 PET 热缩管， 热缩后的厚度为 0.012~0.05 mm 。 承载部件 102 的外绝缘层 502 为 TPU 管或 Pebax 管，直径为 0.9~1.2mm ，厚度为 0.05~0.15mm 。 ，输送部件 201 的外绝缘层（未示出）为 PET 或 FEP 热缩管 ，热缩后 的厚度 0.012~0.1 mm 。
本实施例中，电极 101 为环状，并套合在承载部件 102 的外绝缘层 502 的外表面。这样，当承载部件 102 处于第二形状（在肾动脉内）时，承载部件 102 上的电极 101 处于接触肾动脉内壁的位置（靠近肾神经），这样便可以进行调节工作。为了使电极 101 牢固地安装在承载部件 102 的外绝缘层 502 的外表面，并尽量减少对血管壁的损伤，可以使用胶水将电极 101 粘结于承载部件 102 的外绝缘层 502 上。这类胶水可选用 UV 固化胶、环氧树脂胶或其混合物，既具有能达到医疗用途的生物相容性，又对金属合金和高分子材料都有一定的粘结力。另外，在承载部件 102 的外绝缘层 502 和内绝缘层 501 之间设置有 用于为电极 101 提供调节能量和监控消融时的温度和阻抗的 导线 505 ，导线 505 在输送部件 201 的外绝缘层和内绝缘层中延伸，承载部件 102 中的导线 505 和输送部件 201 中的导线 505 是一体的。导线 505 穿过承载部件 102 的外绝缘层 502 与电极 101 的内表面 通过锡焊或激光 焊接在一起。承载部件 102 的外绝缘层 502 在电极 101 附着的位置有开口 ( 图中未示出 ) ， 连接到能量产生设备（例如射频仪）的导线 505 穿过该开口与电极 101 的内表面焊接在一起。通过将导线 505 设置在外绝缘层 502 内可以避免为了绝缘而必须将导线设置在输送部件的外表面而引起输送部件的外表面凹凸不平的技术弊端，从而避免了因为输送部件的外表面凹凸不平引起的诸多问题。当具有多个电极 101 时，需要设置多根分别将多个电极 101 连接到能量产生设备的导线 505 。每一个电极 101 独立工作，分别具有单独的导线 505 。 一个电极是否释放调节能量，与其他电极无关；可以仅有一个或部分电极传递调节能量，也可以所有电极同时工作，传递调节能量；每个电极是否传递调节能量的状态是彼此独立的。 承载部件 102 上还可以设置用于测量温度的元件（例如，热电偶）以及相应的导线，导线及热电偶的布置为本领域的常规设置，这里不再详述。
本实施例中， 承载部件 102 的第一形状为直的或近似直的，也可以是细长状或纤维状或丝状，该条形的横截面优选为圆形或近似圆形，横截面的最宽处小于血管的内直径。这样，在第一形状下，当调节组件 100 在血管中移动时，调节组件 100 不会损伤血管壁。当需要对肾动脉上的神经进行调节时，由于人肾动脉的内直径一般为 4-7 mm ，因此，调节组件 100 在肾动脉的径向上的最大尺寸不大于 4 mm ，最好设置为 1-2 mm ，既可以满足在血管内方便移动，又具有足够的刚性并且便于制作，并可以减小患者的伤口的尺寸。作为该具体实施方式的变化，第一形状也可以允许一定的弯曲或者波浪形的弯曲，其横截面也可以为其它形状，只要其表面光滑，能够方便地在血管内移动而不损伤血管壁即可。
本实施例中，承载部件 102 的第二形状整体为螺旋形或近似螺旋形，在血管的径向上，承载部件 102 的最宽处比第一形状大，这样可以使承载的电极 101 靠近或接触血管壁，从而靠近肾神经。
考虑到血管具有一定的弹性，承载部件 102 的螺旋形或近似螺旋形的直径设置为 4~12mm 、螺距为 3~10 mm 。针对肾动脉内径较小的个体，例如内径为 4mm 左右，可以将承载部件 102 的螺旋形或近似螺旋形的直径设置为 5~6mm 左右；针对肾动脉内径较大的个体，例如内径为 7mm 左右，可以将螺旋形或近似螺旋形的直径设置为 8~9mm 左右。
承载部件 102 的第二形状也可以为其它形状，例如具有圆滑的弯曲的无规则形状，只要是当该承载部件 102 在血管中时，电极 101 处于接触血管壁的位置即可。
本实施例的多电极肾动脉射频消融导管 通过鞘管 301 和导引导丝的共同作用使承载部件 102 在第一形状和第二形状之间切换，即当鞘管 301 沿输送部件 201 滑动并外套于调节组件 100 ，同时导引导丝从导丝通道 500 的远端的开口 106 插入导丝通道 500 而进入承载部件 102 的内部时，承载部件 102 由第二形状切换为第一形状；当导引导丝从导丝通道 500 的近端的开口 107 穿出并抽离承载部件 102 的内部，同时鞘管 301 沿输送部件 201 滑动并脱离所述调节组件 100 时，承载部件 102 由第一形状切换为第二形状。
在其它实施例中，对于承载部件 102 的径向支撑力较小的情况，可以通过鞘管 301 或导引导丝的单独作用实现承载部件 102 在第一形状和第二形状之间的切换。鞘管 301 的单独作用是指当鞘管 301 沿输送部件 201 滑动并外套于调节组件 100 时，承载部件 102 由第二形状切换为第一形状；当鞘管 301 沿输送部件 201 滑动并脱离调节组件 100 时，承载部件 102 由第一形状切换为所述第二形状。导引导丝的单独作用是指当导引导丝从从导丝通道 500 的远端的开口 106 插入导丝通道 500 而进入承载部件 102 的的内部时，承载部件 102 由第二形状切换为第一形状；当导引导丝从导丝通道 500 的近端的开口 107 穿出并抽离承载部件 102 的内部时，承载部件 102 由第一形状切换为第二形状。
本实施例中多电极肾动脉射频消融导管的工作过程如下：
（ 1 ） 先将导引导丝导入人体预定部位，即人肾动脉上的肾交感神经处；
（ 2 ）将鞘管 301 外套于调节组件 100 ，然后将导引导丝从第一孔插入承载部件 102 并从第二孔穿出，使得承载部件 102 由预成形的第二形状变成第一形状，便于在血管中移动；
（ 3 ）移动多电极肾动脉射频消融导管到人体肾动脉上的肾交感神经处；
（ 4 ）将导引导丝抽离承载部件 102 ，并将鞘管 301 脱离调节组件 100 ，承载部件 102 由第一形状变成第二形状，此时，承载部件 102 上的电极 101 紧贴血管内壁作用于相应位置的神经，释放能量 一定的能量并作用于该神经位点，从而起到调节该神经位点（例如，降低或消除交感神经的活化）的作用；
（ 5 ） 将鞘管 301 外套于调节组件 100 ，然后将导引导丝推入承载部件 102 ，承载部件 102 再次由第二形状变为第一形状；
（ 6 ）将多电极肾动脉射频消融导管移出人体。
电极 101 可以通过将热量传递到该神经位点而实现该目的。例如，用于神经调节的传热加热机制可以包括热消融和非消融的热变或损伤，例如，可以将靶神经纤维的温度升高超过所需阈值以实现非消融的热变，或超过更高的温度以实现消融的热变。例如，靶温度可以在大约 37 ℃ -45 ℃（用于非热消融的热变温度），或者，所述靶温度可以在大约 45 ℃或更高，以用于消融的热变。
电极 101 也可以通过将冷却传递到该神经位点而实现该目的。例如，将靶神经纤维的温度降低到约 20 ℃以下以实现非冷冻的热变，或者将靶神经纤维的温度降低到约 0 ℃以下以实现冷冻的热变。
电极 101 也可以通过将能量场施加到靶神经纤维来实现。该能量场可以包括：电磁能、射频、超声波（包括高强度聚焦超声波）、微波、光能（包括激光、红外线和近红外线）等。例如，热诱导的神经调节可以通过将脉冲的或连续的热能场递送到靶神经纤维而实现。其中，一种比较优选的能量方式是脉冲射频电场或其它类型的脉冲热能。脉冲射频电场或其它类型的脉冲热能可以促成更大的热量级别、更长的总持续时间和 / 或更好的受控的血管内肾神经调节治疗。
无论通过何种能量方式实现调节神经的目的，当使用者使用本发明所提供的导管进行工作时，电极 101 需要与产生该能量（例如射频仪）或使电极 101 本身产生该能量的设备进行电连接。这些设备以及电极与这些设备的连接为本领域技术人员所熟知的现有技术（例如，在本发明装置中设置用于连接这些设备的接口，使用时可实现即插即用），这里不再详细叙述。
本实施例中，电极 101 的数目为 4 个。当 承载部件 102 处于第二形状（螺旋状）时，相邻的电极 101 在血管的轴向上的距离 D 为 4~12 mm 比较适宜。一般说来，进行肾神经消融手术时，对肾神经的 3-8 个位点进行消融。因此，利用该具体实施方式中的装置进行工作时，一次调节组件 100 的定位（使电极 101 接触血管内壁）可完成 4 个位点的消融，而完成整个消融手术只需要进行两次调节组件 100 的定位即可。作为该具体实施方式的变化，电极 101 的数目也可以设置为 2~6 个，但如果数目较多，会增加整个装置的制作成本；如果数目较少，可降低消融手术的工作效率。电极 101 的材料可采用生物相容性较好或比较稳定的金属或金属合金，例如铂族金属（如铂铱合金）。
本实施例的导引导丝为金属丝，由 NiTi 合金制成。
本实施例的多电极肾动脉射频消融导管还包括用于握持的手柄 401 ，该手柄 401 的远端与输送部件 201 的近端连接（参见图 3 ）。导线 505 在承载部件 102 和输送部件 201 内延伸后与手柄 401 连接。 手柄 401 与外部能量发生器的连接电缆设置为一体或通过转换端口连接的独立的两部分。 本实施例的 鞘管 301 的移动由设置在手柄 401 内的控制机构 7 控制，参见图 3 和图 7 ， 控制机构 7 包括端头 701 、齿块 702 和齿轮 703 ，端头 701 位于手柄 401 的远端并与鞘管 301 连接，齿块 702 与端头 701 连接，齿轮 703 与齿块 702 匹配；转动齿轮 703 能够使齿块 702 推拉端头 701 ，从而端头 701 推拉鞘管 301 沿输送部件 201 移动。
鞘管 301 的材质为高分子材料，如 Pebax 或 TPU ， 比承载部件 102 的材质稍硬， 硬度为 50A-50D 。鞘管 301 包括内层 302 和外层 303 ，如图 8 所示，内层 302 的材质为 PTFE ，壁厚为 0.015-0.5mm ，摩擦系数较小，当鞘管 301 相对于承载部件 102 相对滑动时主要起到顺滑作用。外层 303 的材质为 Pebax 或 TPU ，可以含有 20 wt% ~ 40wt%BaSO4 或 10 wt% ~30 wt% 的 BiOCl 。
除外层距离鞘管 301 的最远端 1~5 mm 的部分外，外层的其余部分具有编织网管， 如图 9 所示，编织网管包括第一编织丝段 313 、第二编织丝段 323 和第三编织丝段 333 ；第一编织丝段 313 、第二编织丝段 323 和第三编织丝段 333 的编织丝为不锈钢丝或 Ni-Ti 丝。第一编织丝段 313 、第二编织丝段 323 和第三编织丝段 333 不同的硬度可以通过相同的编织方式和各自所在的所述外层中的 Pebax 的不同硬度来实现，也可以通过相同的 Pebax 硬度和不同的编织方式来实现。本实施例中， 第一编织丝段 313 、第二编织丝段 323 和第三编织丝段 333 的编织丝的编制方式不同，使鞘管 301 靠近 401 手柄的远端 10~20 cm 的部分的硬度大于鞘管 301 的其它部分的硬度。 鞘管 301 的远端的硬度具有从小到大的过渡，便于本实施例的多电极肾动脉消融导管进入肾动脉预定位置。
以上详细描述了本 发明 的较佳具体实施例。应当理解，本领域的普通技术人员无需创造性劳动就可以根据本 发明 的构思作出诸多修改和变化。因此，凡本技术领域中技术人员依本 发明 的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案，皆应在由权利要求书所确定的保护范围内。

Claims (51)

  1. 一种多电极肾动脉消融导管，包括用于调节神经的调节组件和用于将所述调节组件输送到所述神经的位置的输送部件；
    所述调节组件包括用于将调节能量传递到所述神经的多个电极和用于承载多个所述电极的承载部件；
    所述承载部件具有第一形状和第二形状，在所述第一形状下，所述调节组件适于在血管中移动；在所述第二形状下，至少一个所述电极处于适合将所述调节能量传递到所述神经的位置；
    其特征在于，所述多电极肾动脉消融导管还包括鞘管；所述鞘管外套于所述输送部件，所述鞘管能够沿所述输送部件滑动并外套于或脱离所述调节组件；
    所述多电极肾动脉消融导管的内部设置有导丝通道，所述导丝通道贯穿整个所述多电极肾动脉消融导管，所述导丝通道用于导引导丝在所述多电极肾动脉消融导管的内部沿所述多电极肾动脉消融导管的轴向移动；
    所述多电极肾动脉消融导管被配置为：通过所述鞘管或所述导引导丝的单独作用或通过所述鞘管和所述导引导丝的共同作用能够使所述承载部件在所述第一形状和所述第二形状之间切换。
  2. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述鞘管的单独作用是指当所述鞘管沿所述输送部件滑动并外套于所述调节组件时，所述承载部件由所述第二形状切换为所述第一形状；当所述鞘管沿所述输送部件滑动并脱离所述调节组件时，所述承载部件由所述第一形状切换为所述第二形状。
  3. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述导丝通道的近端和远端均具有开口。
  4. 如权利要求3所述的多电极肾动脉消融导管，其特征在于，所述导引导丝的单独作用是指当所述导引导丝从所述导丝通道的所述远端的开口插入所述导丝通道而进入所述承载部件的内部时，所述承载部件由所述第二形状切换为所述第一形状；当所述导引导丝从所述导丝通道的所述近端的开口穿出并抽离所述承载部件的内部时，所述承载部件由所述第一形状切换为所述第二形状。
  5. 如权利要求3所述的多电极肾动脉消融导管，其特征在于，所述鞘管和所述导引导丝的共同作用是指当所述鞘管沿所述输送部件滑动并外套于所述调节组件，同时所述导引导丝从所述导丝通道的所述远端的开口插入所述导丝通道而进入所述承载部件的内部时，所述承载部件由所述第二形状切换为所述第一形状；当所述导引导丝从所述导丝通道的所述近端的开口穿出并抽离所述承载部件，同时所述鞘管沿所述输送部件滑动并脱离所述调节组件时，所述承载部件由所述第一形状切换为所述第二形状。
  6. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件与所述输送部件均为管状，且沿所述管状的径向由内向外依次为高分子层、NiTi管、内绝缘层和外绝缘层。
  7. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述承载部件的高分子层和所述输送部件的高分子层的直径均为0.40~0.55mm，厚度均为0.025~0.1 mm。
  8. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述承载部件的高分子层和所述输送部件的高分子层为一体的，由高分子材料形成。
  9. 如权利要求8所述的多电极肾动脉消融导管，其特征在于，所述高分子材料为PET、FEP、Pebax、PE或PTFE。
  10. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述承载部件的NiTi管的表面具有切割花纹，所述切割花纹为通过激光切割在所述承载部件的NiTi管的表面形成的螺旋线槽。
  11. 如权利要求10所述的多电极肾动脉消融导管，其特征在于，当所述承载部件处于所述第一形状时，所述螺旋线槽在水平面的投影包括多个直线槽和多个近似直线槽。
  12. 如权利要求11所述的多电极肾动脉消融导管，其特征在于，所述多个直线槽位于所述承载部件的远端，所述多个直线槽包括多个第一直线槽和多个第二直线槽。
  13. 如权利要求12所述的多电极肾动脉消融导管，其特征在于，每相邻两个所述第一直线槽的间距相同，多个所述第一直线槽之间互相平行。
  14. 如权利要求12所述的多电极肾动脉消融导管，其特征在于，每相邻两个所述第二直线槽的间距相同，多个所述第二直线槽彼此之间互相平行。
  15. 如权利要求12所述的多电极肾动脉消融导管，其特征在于，所述第一直线槽与所述承载部件的轴向的夹角为75°~85°，所述第二直线槽与所述承载部件的轴向的夹角为65°~75°，所述近似直线槽与所述承载部件的轴向的夹角为50°~65°，所述轴向是指当所述承载部件处于所述第一形状时，从所述承载部件的近端指向所述承载部件的远端的方向。
  16. 如权利要求11所述的多电极肾动脉消融导管，其特征在于，所述多个近似直线槽位于所述承载部件的近端，从所述承载部件的远端至近端，相邻两个所述近似直线槽之间的间距是逐渐增大的，多个所述近似直线槽彼此之间互不平行。
  17. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述承载部件的内绝缘层和所述输送部件的内绝缘层均为PET热缩管，热缩后的厚度为0.012~0.05 mm。
  18. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述承载部件的外绝缘层为TPU管或Pebax管，直径为0.9~1.2mm，厚度为0.05~0.15mm。
  19. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述输送部件的外绝缘层为PET或FEP热缩管，热缩后的厚度0.012~0.1mm。
  20. 如权利要求6所述的多电极肾动脉消融导管，其特征在于，所述电极套合于所述承载部件的外层绝缘层的外部，并通过粘结剂加强固定。
  21. 如权利要求20所述的多电极肾动脉消融导管，其特征在于，所述粘结剂为UV固化胶或环氧树脂胶。
  22. 如权利要求20所述的多电极肾动脉消融导管，其特征在于，多个所述电极单独控制释放能量。
  23. 如权利要求20所述的多电极肾动脉消融导管，其特征在于，多个所述电极同时控制释放能量。
  24. 如权利要求22或23所述的多电极肾动脉消融导管，其特征在于，每个所述电极的内表面与导线相连，所述导线用于为所述电极提供所述调节能量和监控消融时的温度和阻抗。
  25. 如权利要求24所述的多电极肾动脉消融导管，其特征在于，所述导线设置于所述承载部件的外绝缘层和内绝缘层之间，并在所述输送部件的外绝缘层和内绝缘层之间延伸。
  26. 如权利要求25所述的多电极肾动脉消融导管，其特征在于，所述导线穿过所述承载部件的外绝缘层与所述电极的内表面通过锡焊或激光焊接在一起。
  27. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件的所述第一形状为直的或近似直的。
  28. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件的所述第二形状为螺旋形或近似螺旋形。
  29. 如权利要求25所述的多电极肾动脉消融导管，其特征在于，所述螺旋形或所述近似螺旋形的直径为4~12 mm、螺距为3~10 mm。
  30. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件为扰性的，且被预处理为具有所述第二形状。
  31. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述电极的横截面为环形。
  32. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述电极的数目为2~6个，当所述承载部件处于所述第一形状时，相邻的所述电极之间的距离为4~12 mm。
  33. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述电极采用铂铱合金或黄金材质。
  34. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述多电极肾动脉消融导管还包括用于握持的手柄，所述手柄的远端与所述输送部件的近端连接。
  35. 如权利要求34所述的多电极肾动脉消融导管，其特征在于，所述手柄内设置有控制机构，所述控制机构用于控制所述鞘管的移动。
  36. 如权利要求35所述的多电极肾动脉消融导管，其特征在于，所述控制机构包括端头、齿块和齿轮，所述端头位于所述手柄的远端并与所述鞘管连接，所述齿块与所述端头连接，所述齿轮与所述齿块匹配；转动所述齿轮能够使所述齿块推拉所述端头，从而所述端头推拉所述鞘管沿所述输送部件移动。
  37. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件和所述输送部件是一体的。
  38. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件的近端与所述输送部件的远端相连。
  39. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述鞘管的内径为1.2~1.45 mm，外径为1.3~1.55 mm。
  40. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述鞘管包括内层和外层。
  41. 如权利要求40所述的多电极肾动脉消融导管，其特征在于，所述内层的材质为PTFE，厚度为0.015~0.5 mm。
  42. 如权利要求40所述的多电极肾动脉消融导管，其特征在于，所述外层为Pebax或TPU，所述Pebax或TPU中含有20 wt% ~ 40wt%BaSO4或10 wt% ~30 wt%的BiOCl。
  43. 如权利要求40所述的多电极肾动脉消融导管，其特征在于，除所述外层距离所述鞘管的最远端1~5 mm的部分外，所述外层的其余部分具有编织网管。
  44. 如权利要求43所述的多电极肾动脉消融导管，其特征在于，所述编织网管包括第一编织丝段、第二编织丝段和第三编织丝段。
  45. 如权利要求44所述的多电极肾动脉消融导管，其特征在于，所述第一编织丝段、所述第二编织丝段和所述第三编织丝段的编织丝为不锈钢丝或NiTi丝。
  46. 如权利要求44所述的多电极肾动脉消融导管，其特征在于，所述第一编织丝段、所述第二编织丝段和所述第三编织丝段的编织丝的编制方式不同，使所述鞘管靠近所述手柄的远端10~20 cm的部分的硬度大于所述鞘管的其它部分的硬度。
  47. 如权利要求43所述的多电极肾动脉消融导管，其特征在于，所述鞘管的远端的硬度具有从小到大的过渡，便于所述多电极肾动脉消融导管进入肾动脉预定位置。
  48. 如权利要求1所述的多电极肾动脉消融导管，其特征在于，所述承载部件的远端设置有用于减少或避免血管壁损伤的保护部件。
  49. 如权利要求48所述的多电极肾动脉消融导管，其特征在于，所述保护部件为软头。
  50. 如权利要求49所述的多电极肾动脉消融导管，其特征在于，所述软头具有用于所述导引导丝插入所述承载部件的开口，所述软头的开口为所述导丝通道远端的开口。
  51. 如权利要求48所述的多电极肾动脉消融导管，其特征在于，所述保护部件由橡胶、硅胶或热塑性弹性体材料制成。
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