WO2023138275A1 - 消融装置 - Google Patents

消融装置 Download PDF

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Publication number
WO2023138275A1
WO2023138275A1 PCT/CN2022/139652 CN2022139652W WO2023138275A1 WO 2023138275 A1 WO2023138275 A1 WO 2023138275A1 CN 2022139652 W CN2022139652 W CN 2022139652W WO 2023138275 A1 WO2023138275 A1 WO 2023138275A1
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electrodes
rod
rods
ablation device
ablation
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PCT/CN2022/139652
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English (en)
French (fr)
Inventor
刘成
王坤
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杭州德诺电生理医疗科技有限公司
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Publication of WO2023138275A1 publication Critical patent/WO2023138275A1/zh

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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
    • 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
    • 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
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using 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
    • A61B2018/00053—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
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • 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
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A61B2018/1861—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves with an instrument inserted into a body lumen or cavity, e.g. a catheter

Definitions

  • the invention relates to the technical field of medical devices, in particular to an ablation device.
  • Electrophysiological mapping plays a very important role in the field of electrophysiology. Electrophysiological mapping is used to record electrophysiological signals in the body, so as to find abnormal lesions and guide ablation. After ablation treatment is performed, the effect of treatment is verified through mapping.
  • mapping catheter Existing electrophysiological mapping is generally implemented by using a mapping catheter, and at the same time, an ablation catheter is used to complete the ablation treatment, which leads to the need to insert multiple devices into and remove from the patient's body during the operation.
  • a mapping catheter is used for electrophysiological mapping. Once the mapping is completed, the mapping catheter can be removed and an ablation catheter can be inserted in its position. After the ablation is completed, the mapping catheter can be inserted again for mapping to verify the effect of the ablation treatment.
  • two devices, the ablation catheter and the mapping catheter need to be guided separately during the operation, which will lead to many defects such as complicated operation steps, long operation time, and high cost.
  • an ablation device comprising: an outer tube; an ablation assembly, which is arranged at the distal end of the outer tube, including a radially contractible and expandable support frame and a plurality of electrodes arranged on the support frame; wherein, among the plurality of electrodes, there is at least one first electrode that can be used for mapping; a connector, which is arranged at the proximal end of the outer tube, and the connector includes a plurality of conductive terminals, and the connector is electrically connected to the plurality of electrodes through the plurality of conductive terminals.
  • the first terminal forms a one-to-one electrical connection with a corresponding one of the first electrodes, so that when the connector is connected to an external mapping device, the first electrode can be used for mapping through the first terminal.
  • the ablation device in the embodiment of the present invention can ablate the target ablation area through a radially expandable support frame and a plurality of electrodes arranged on the support frame; at the same time, these electrodes have a first electrode that forms a one-to-one connection with the first terminal on the connector, so that when the connector is connected to an external mapping device, the first electrode can also be used for electrophysiological mapping through the corresponding first terminal, so that the ablation device has the functions of both mapping and ablation, making the operation more convenient and improving the operation efficiency.
  • Fig. 1a is a schematic diagram of the ablation device according to the first embodiment of the present invention.
  • Figure 1b is a schematic diagram of the connector installed on the handle.
  • Fig. 1c is a schematic diagram of connecting the connector with an external ablation energy source or an external mapping device.
  • Fig. 1d is a schematic diagram of a reference electrode provided on the puller of the ablation device.
  • Fig. 1e is a schematic diagram of a reference electrode provided at the distal end of the support frame of the ablation device.
  • Fig. 2 is a schematic diagram of an ablation device according to a second embodiment of the present invention.
  • FIG. 3 is a top view of FIG. 2 .
  • Fig. 4 is a schematic diagram of the state of compressive deformation of the support frame in Fig. 2 along the axial direction.
  • Fig. 5 is a schematic diagram of an ablation device according to a third embodiment of the present invention.
  • Fig. 6 is a partial enlarged view of A in Fig. 5 .
  • FIG. 7 is a top view of FIG. 5 .
  • Fig. 8 is a schematic diagram of an ablation device according to a fourth embodiment of the present invention.
  • Fig. 9 is a schematic diagram of an ablation device according to a fifth embodiment of the present invention.
  • Fig. 10 is a schematic diagram of an ablation device according to a sixth embodiment of the present invention.
  • Fig. 11 is a schematic diagram of an ablation device according to a seventh embodiment of the present invention.
  • Fig. 12 is a schematic diagram of an ablation device according to an eighth embodiment of the present invention.
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • a feature defined as “first” or “second” may explicitly or implicitly include one or more of said features.
  • “plurality” means two or more, unless otherwise specifically defined.
  • An embodiment of the present invention provides an ablation device with a mapping function, which can be used for cardiac ablation. It can be transported to a specific location of the heart by means of percutaneous puncture, and then an external ablation energy source such as pulsed electric field, radio frequency, or microwave is used to ablate the pulmonary vein, left atrial appendage, or a combination of typical atrial flutter and trigger lesions (such as superior vena cava, coronary venous ostium) originating from non-pulmonary veins, etc., to achieve the effect of electrical isolation. It can be understood that cardiac ablation is a typical application of the ablation device, and the ablation device may also act on other body tissues under feasible conditions, which is not limited here.
  • an external ablation energy source such as pulsed electric field, radio frequency, or microwave is used to ablate the pulmonary vein, left atrial appendage, or a combination of typical atrial flutter and trigger lesions (such as superior vena cava, coronary venous ostium) originating from non-
  • the ablation device is equipped with electrodes for ablation, and the electrodes on it can be directly used for electrophysiological mapping before and after ablation, so that the ablation device has the functions of mapping and ablation at the same time, and the operation is more convenient, which is conducive to improving the success rate of the operation.
  • Proximal end and distal end In the field of interventional medical devices, the end close to the operator of a medical device implanted in the human or animal body is generally referred to as the "proximal end”, and the end far away from the operator is referred to as the “distal end”.
  • This article defines the "proximal end” and “distal end” of any part of the ablation device based on this principle.
  • “Axial” generally refers to the length direction of the medical device when it is transported
  • radial generally refers to the direction perpendicular to the “axial” of the medical device
  • circumumferential generally refers to the direction around the "axial”.
  • Insulation layer It is formed by insulating the surface of a component to insulate that part of the component. Specifically, the insulating layer is formed in the following ways: coating an insulating coating material at the position where insulation treatment is required.
  • the coating material includes but is not limited to Parylene coating, PTFE (Poly-tetra-fluoroethylene, polytetrafluoroethylene) coating, PI (Polyimide, polyimide) coating; thane, polyurethane), ETFE (Ethylene-tetra-fluoro-ethylene, ethylene-tetrafluoroethylene copolymer), PFA (Polyfluoroalkoxy, tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer), PTFE, PEEK (Poly-ether-ether-ketone, polyetheretherketone), silica gel; or, wear insulating sleeves at the positions that need to be insulated.
  • the materials of the insulating sleeves include but are not limited to F
  • Pulse ablation Using a high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field, to cause cell apoptosis to achieve non-thermal ablation of cells, so it is not affected by the heat sink effect.
  • the high-voltage pulse sequence produces less heat and does not need saline irrigation for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus.
  • the pulse ablation treatment time is short, the treatment time of applying a set of pulse sequences is less than 1 minute, and the whole ablation time is generally no more than 5 minutes.
  • the ablation device of this embodiment mainly includes an outer tube 1 , an ablation assembly 2 arranged at the distal end of the outer tube 1 , and a connector 3 arranged at the proximal end of the outer tube 1 .
  • the ablation device further includes a traction member 4 passing through the outer tube 1 and connected to the ablation assembly 2 .
  • the ablation device can be delivered to the inside of the heart through a delivery device, which generally includes a sheath, a handle, etc.
  • a delivery device which generally includes a sheath, a handle, etc.
  • the connector 3 of the ablation device may be arranged on the handle 100, as shown in FIG. 1b.
  • the outer tube 1 is a hollow tubular structure, the axis L of which extends along the direction of the distal end and the proximal end.
  • the outer tube 1 has a single axial lumen or central lumen (not shown in the figure) inside.
  • the outer tube 1 can also be configured to have multiple lumens, so as to accommodate pull wires, lead wires, sensor cables and any other wires, cables and/or tubes that may be required in specific applications through the multiple lumens.
  • the outer tube 1 can also have any suitable structure and can be made of any suitable material, for example, one structure includes an outer wall made of polyurethane or PEBAX (Polyether-block-amide, polyether block amide) and other polymer materials.
  • PEBAX Polyether-block-amide, polyether block amide
  • the outer tube 1 has certain flexibility and can be bent to adapt to the curved structure inside the heart.
  • the ablation assembly 2 includes a radially contractable and expandable support framework 21 and a plurality of electrodes 22 arranged on the support framework 21 .
  • the proximal end of the supporting frame 21 is connected to the distal end of the outer tube 1 , and the distal end of the supporting frame 21 is gathered toward the axis L of the outer tube 1 .
  • Fig. 1a illustrates the structure of the support frame 21 in an expanded state. At this time, the two ends of the support frame 21 are gathered and the middle part is expanded, and the outline of the support frame 21 is roughly in the shape of a basket.
  • the supporting frame 21 can also be in other configurations, such as spherical, egg-shaped, pumpkin-shaped, lantern-shaped, elliptical and so on.
  • the supporting frame 21 can shrink radially inwards relative to the axis L of the outer tube 1, that is, the middle part of the supporting frame 21 is also retracted in the direction of the axis L of the outer tube 1, and the supporting frame 21 will be straightened into a roughly linear state in a contracted state.
  • the axial length of the support skeleton 21 in the contracted state will be greater than its axial length in the expanded state.
  • the support frame 21 can be accommodated in the sheath so as to be conveniently delivered into the human body through the sheath.
  • the support frame 21 is released from the sheath, and then expands radially to the expanded state shown in FIG. 1 a .
  • the radial expansion of the support frame 21 may be self-expanded and stretched when it is stretched out of the sheath, or the support frame 21 is radially expanded under human intervention after being stretched out of the sheath.
  • the traction member 4 can be used to control the contraction and expansion of the support frame 21 , which will be described in detail below.
  • the support frame 21 can be cut from elastic metal pipes, or braided from elastic metal wires, or processed by partial weaving combined with local pipe cutting. The parts obtained by different processing methods can be welded or fixed to each other by connecting pieces.
  • the material of the pipe is metal or non-metal material, preferably memory metal material or nickel-titanium alloy material.
  • the supporting frame 21 can be formed by cutting and shaping a nickel-titanium alloy pipe.
  • the supporting frame 21 includes a plurality of bearing rods 211 arranged circumferentially around the axis L of the outer tube 1; the plurality of bearing rods 211 are surrounded to form a radially contractable and expandable structure.
  • six bearing rods 211 are arranged circumferentially around the axis L of the outer tube 1 , and the bearing rods 211 are evenly arranged along the circumferential direction.
  • the number of load bars 211 may be four, five, six, seven, eight, nine, ten, eleven, twelve or any other suitable number.
  • the bearing bars 211 may be evenly or non-uniformly spaced circumferentially.
  • each bearing rod 211 is connected to the distal end of the outer tube 1 , and the distal ends of the plurality of bearing rods 211 converge toward the axis L of the outer tube 1 .
  • the distal end of each bearing rod 211 is connected to the traction member 4 , and can make the support frame 21 shrink or expand under the control of the traction member 4 .
  • the traction member 4 is coaxially threaded inside the outer tube 1 , and the distal end of the traction member 4 protrudes from the distal end of the outer tube 1 toward the distal end and connects the distal ends of the bearing rods 211 .
  • the traction member 4 can move axially relative to the outer tube 1 , thereby driving the supporting frame 21 to expand or contract radially.
  • the proximal end of the traction member 4 can be connected with the handle 100, and the handle 100 pulls the traction member 4 to drive the traction member 4 to move in the axial direction.
  • the traction member 4 moves relative to the outer tube 1 from the distal end to the proximal end, the distal end of each bearing rod 211 moves to the proximal end along with the traction member 4, and the middle part of the bearing rod 211 will gradually expand radially outward, so that the outer diameter of the supporting frame 21 will increase, that is, expand outward.
  • the outer diameter of the supporting skeleton 21 can be flexibly regulated, so that the support skeleton 21 can adapt to the blood vessels (such as pulmonary veins) or other body tissues of different diameter sizes, and can blend the target melting area under the conditions of any appropriate outer diameter size.
  • the ablation is performed under the circumstances of the largest degree, which improves the adaptability of supporting skeleton 21 to the anatomical form of the dislocation of different targets.
  • the traction member 4 can be a steel cable, a flexible polyimide (PI) tube, a fluorinated polyethylene (PDFE) tube, a stainless steel tube, or a tube made of other polymer materials.
  • PI flexible polyimide
  • PDFE fluorinated polyethylene
  • the traction member 4 has a certain structural strength, so as to buffer the external force received by the bearing rod 211 and effectively ensure the stability of the position of the bearing rod 211 .
  • the ablation device may not be provided with a traction member 4, and the support frame 21 expands radially in a self-expanding manner. At this time, the diameter of the support frame 21 is not adjustable, and can be applied to ablation targets of a fixed size area.
  • a plurality of electrodes 22 are respectively arranged on each supporting rod 211 of the supporting frame 21 . After the support frame 21 is radially expanded, each bearing rod 211 can fit the inner wall of the tissue inside the heart, and the electrodes 22 use the ablation energy to perform tissue ablation. It should be noted that the electrodes 22 are disposed on the supporting frame 21 , and during the radial expansion of the supporting frame 21 , the radial positions of the electrodes 22 may change along with the expansion of the supporting frame 21 .
  • a plurality of electrodes 22 are arranged at intervals along the axial direction on each bearing rod 211 .
  • the electrodes 22 correspond to each other in the axial direction, and are arranged at intervals around the axis L of the outer tube 1 in the circumferential direction.
  • one or more electrodes 22 may also be provided only on part of the bearing rod 211 .
  • each supporting rod 211 The position of the bearing rod 211 farthest from the axis L of the outer tube 1 in the radial direction is called the outermost end 2111.
  • the electrodes 22 in this embodiment are arranged between the distal end of the bearing rod 211 and the outermost end 2111, so as to ensure that the distance between the electrodes 22 is in a relatively suitable range to avoid arcing, and at the same time ensure that the electrodes 22 can better conform to the atrial tissue and maintain good adhesion.
  • One of the electrodes 22 is located at the outermost end 2111 .
  • the electrodes 22 may be ring-shaped electrodes, sheet-shaped electrodes, point-shaped electrodes, or spherical electrodes, etc., which are not specifically limited in this embodiment.
  • the electrode 22 can be made of platinum-iridium alloy, gold, other platinum alloys, stainless steel, nickel-titanium or any other biocompatible medical metal.
  • the inner wall of each electrode 22 is welded with a wire 5 with an insulating layer.
  • the carrying rod 211 includes a rod body and an insulating sleeve sleeved on the outside of the rod body.
  • the material of the insulating sleeve is PEBAX pipe or other polymer insulating materials, which ensures the insulation between the electrode 22 and the rod body.
  • the insulating sleeve can be one layer, two layers or multiple layers, which is not limited here.
  • the cross-sectional shape of the rod body can be ellipse, circle, rectangle, semicircle, drum or other shapes, which is not limited here.
  • the rod body is made of nickel-titanium wire, so that the rod body has excellent elastic properties and strength, so that it can be well attached to the target ablation area. It can be understood that the rod body can also be made of other materials, such as stainless steel or polymer materials.
  • the electrode 22 is set on the insulating sleeve of the bearing rod 211, which ensures the insulation between the electrode 22 and the rod body.
  • the wire 5 is placed between the rod body and the insulating sleeve, that is, the inner surface of each electrode 22 passes through a wire 5 from the surface of the insulating sleeve, and is connected to the connector 3 along the bearing rod 211 and the outer tube 1.
  • the electrode 22 and the wire 5 are connected by welding or other special processes.
  • the connector 3 generally includes an insulating housing 31 and a plurality of conductive terminals 32 disposed on the insulating housing 31 .
  • the connector 3 can be installed on the handle 100 through the insulating case 31 .
  • the arrangement of the plurality of conductive terminals 32 can be set according to the actual situation, and is not limited to the arrangement shown in FIG. 1a.
  • the structure of the conductive terminal 32 is not limited, and may be a solid needle terminal, pogo pin, etc.
  • the plurality of conductive terminals 32 are electrically connected to the plurality of electrodes 22 of the ablation assembly 2 through wires 5 , and the wires 5 and the conductive terminals 32 can be connected by welding.
  • the connector 3 can be selectively connected to an external ablation energy source 200 (as shown in FIG. 1c ) or an external mapping device 300 (as shown in FIG. 1c ).
  • the connector 3 is connected to the external ablation energy source 200, the ablation energy can be transmitted to the electrode 22 through the conductive terminal 32 and the wire 5, so that the electrode 22 can be used for ablation.
  • the electrodes 22 that meet the mapping requirements can transmit the collected electrophysiological signals to the outside through the wire 5 and the conductive terminal 32 .
  • FIG. 1 a does not show the complete connection relationship between the plurality of conductive terminals 32 and the plurality of electrodes 22 .
  • the conductive terminals 32 and the electrodes 22 may have different corresponding connection relationships. Examples are as follows:
  • the plurality of electrodes 22 of the ablation assembly 2 has at least one first electrode 22a, and the first electrode 22a can be used for mapping.
  • the first electrode 22a is used for ablation when ablation is required, and used for mapping before and after ablation.
  • Two first electrodes 22 a are exemplarily marked in FIG. 1 a , and these two first electrodes 22 a are respectively arranged on two carrying rods 211 .
  • the plurality of conductive terminals 32 of the connector 3 has two first terminals 32a, and each first terminal 32a forms a one-to-one electrical connection with a corresponding first electrode 22a, that is, one first terminal 32a is only connected to one first electrode 22a through a corresponding wire 5, and each first terminal 32a is not connected to other electrodes 22.
  • each first terminal 32a forms a one-to-one electrical connection with a corresponding first electrode 22a, that is, one first terminal 32a is only connected to one first electrode 22a through a corresponding wire 5, and each first terminal 32a is not connected to other electrodes 22.
  • the electrophysiological signal collected by each first electrode 22a is transmitted through the first terminal 32a, it can clearly and uniquely reflect the electrophysiological state at a specific position in the human body, that is, the position where the first electrode 22a is located. Therefore, accurate electrophysiological mapping can be performed, and the first electrode 22a can be used for mapping through the corresponding first terminal 32a.
  • the number and arrangement of the first electrodes 22a
  • the first electrode 22a and the first terminal 32a are electrically connected in a one-to-one manner, when the connector 3 is connected to the external ablation energy source 200 (as shown in FIG. 1c ), the first terminal 32a can also be individually controlled so that the corresponding first electrode 22a is energized or de-energized.
  • the area where the first electrode 22a is located can be locally ablated, without being limited to the entire target ablation area.
  • the ablation device can realize regional ablation. By subregional local ablation, damage to unintended ablated tissues can be avoided.
  • the ablation energy can be targeted to the tissue that needs to be ablated, increasing the utilization rate of the ablation energy, reducing the dissipation of the ablation energy in the blood, and reducing unnecessary bubbles generated by the electrolysis of the blood.
  • partition ablation it is not necessary to energize all the electrodes 22, the total current during ablation is reduced to reduce possible body stimulation, and the short circuit or arc caused by too many electrodes 22 can also be reduced to improve safety.
  • the first electrode 22a when the connector 3 is connected to the external ablation energy source 200, the first electrode 22a can be individually controlled to discharge through the first terminal 32a, so that the first electrode 22a that is controlled to discharge can transmit the ablation energy output by the external ablation energy source 200 to the area where it is located for local ablation.
  • the plurality of electrodes 22 of the ablation assembly 2 there are also a plurality of second electrodes 22b that are only used for ablation.
  • Two second electrodes 22 b are exemplarily marked in FIG. 1 a , and these two second electrodes 22 b are respectively arranged on two carrying rods 211 .
  • the plurality of conductive terminals 32 of the connector 3 has a second terminal 32b that is electrically connected to the two second electrodes 22b at the same time, that is, the two second electrodes 22b are connected to the second terminal 32b through their corresponding wires 5, so that during ablation, the two second electrodes 22b connected to the second terminal 32b will have the same polarity.
  • the number of the second electrodes 22b is not limited to two as shown in FIG. 1a, and there may be more, and the number of the second terminals 32b is less than or equal to the number of the second electrodes 22b.
  • a plurality of second electrodes 22b can be electrically connected to the same second terminal 32b according to the connection method in FIG. 1a, thereby reducing the number of second terminals 32b.
  • the second terminals 32b can be used to assign different polarities to the second electrodes 22b according to the requirements, which is beneficial to form different electric field distributions to meet different ablation requirements.
  • the second terminals 32b can actually be connected one-to-one with the second electrodes 22b. In this case, partitioned ablation can also be realized.
  • connection relationship between the electrode 22 and the conductive terminal 32 in conjunction with FIG. 1a is only a schematic illustration. In actual connection, according to the function of the electrode 22 , a reasonable connection relationship between the electrode 22 and the conductive terminal 32 can be formed, and the corresponding function of the electrode 22 can be realized through the conductive terminal 32 .
  • the connector 3 transmits the ablation energy of the connected external ablation energy source 200 to the electrode 22 through the conductive terminal 32, and the electrode 22 ablates the target ablation area.
  • all electrodes 22 including the first electrode 22a and the second electrode 22b can be used for ablation.
  • the voltage range of the pulse signal received by the electrode 22 is 500V-3000V, including all values and sub-ranges therebetween, and the pulse frequency is 500Hz-500kHz, including all values and sub-ranges therebetween.
  • the pulse energy can be a unipolar pulse high-voltage power supply or a bipolar high-voltage pulse power supply.
  • the bipolar high-voltage pulse signal waveform alternates positive and negative polarity pulses in each cycle.
  • the maximum voltage that the wire 5 bears is 3000V. All the electrodes 22 can be divided into one or more positive-negative electrode sets.
  • the plurality of electrodes 22 on each load bar 211 can be set to the same polarity, which is opposite to the polarity of the electrodes 22 on the adjacent load bar 211;
  • the polarities are opposite, and the polarities of the axially corresponding electrodes 22 on adjacent bearing rods 211 are the same.
  • the energy pulses received by electrodes 22 include monophasic pulses or biphasic pulses, and each electrode 22 can be configured with monophasic or biphasic pulses with different parameters such as voltage, pulse width, repetition frequency, duty cycle, and pulse number.
  • the connector 3 is connected to an external mapping device 300 .
  • the first electrode 22a collects the electrophysiological signal of the target ablation area, and then transmits it to the external mapping device 300 through the first terminal 32a.
  • this embodiment takes three electrodes 22 provided on each carrying rod 211 as an example, and the three electrodes 22 on each carrying rod 211 are referred to as No. 1 electrode 22, No. 2 electrode 22, and No. 3 electrode 22 from the distal end to the proximal end, wherein No. 3 electrode 22 is located at the outermost end 2111 of the carrying rod 211.
  • the first way at least two bearing rods 211 are respectively provided with a first electrode 22a.
  • any two of the first electrodes 22 a are used as a mapping electrode pair for mapping.
  • any electrode 22 on the carrying rod 211 can be used as the first electrode 22a, and the electrode 22 corresponding to the axial direction on different carrying rods 211 can be used as the first electrode 22a, that is, the first electrode 22 on the carrying rod 211 is used as the first electrode 22a, or the second electrode 22 on the carrying rod 211 is used as the first electrode 22a, or the third electrode 22 on the carrying rod 211 is used as the first electrode 22a.
  • the electrodes 22 on the two carrying rods 211 that do not correspond to the axial direction can also be used as the first electrodes 22a, for example, the No. 1 electrode 22 on one of the carrying rods 211 is used as the first electrode 22a, and the No. 3 electrode 22 on the other carrying rod 211 is used as the first electrode 22a.
  • one first electrode 22a is provided on all the carrying rods 211, which has more selectivity, and the large number of first electrodes 22a can also improve the collection range and efficiency of electrophysiological signals, so that the mapping can be more accurate.
  • first electrode 22a on each supporting rod 211 Taking one first electrode 22a on each supporting rod 211 as an example, during mapping, the first electrodes 22a on two adjacent supporting rods 211 form a mapping electrode pair for electrophysiological mapping, for example, two adjacent No. 3 electrodes 22 form a mapping electrode pair.
  • any two first electrodes 22 a may also be used as a mapping electrode pair, for example, any two No. 3 electrodes 22 may be used as the first electrodes 22 a to form a mapping electrode pair.
  • the No. 3 electrode 22 on each supporting bar 211 is the first electrode 22a.
  • the No. 3 electrode 22 is located at the position of the bearing rod 211 that is farthest from the axis L of the outer tube 1 in the radial direction, that is, the position where the support frame 21 has the largest radial dimension after expansion, therefore, after the support frame 21 expands, the No. 3 electrode 22 can be fully attached to the target ablation area, with good adhesion, and it is easier to map the potential.
  • the second way among the plurality of electrodes 22 on at least one carrying rod 211 , there are two first electrodes 22 a that are not adjacently arranged.
  • any pair of first electrodes 22a are used to form a mapping electrode pair for mapping.
  • two first electrodes 22a on the same carrying rod 211 are used as a mapping electrode pair, but in other embodiments, two first electrodes 22a arranged on different carrying rods 211 can also be used as a mapping electrode pair.
  • the first electrode 22a includes the No. 3 electrode 22 located at the outermost end 2111 of the bearing rod 211, which has the advantage of good adhesion.
  • the total number of first electrodes 22a is twelve, which can form six pairs of mapping electrodes.
  • the increase in the number can greatly improve the collection range and efficiency of electrophysiological signals, thereby making the mapping more accurate.
  • the third manner among the plurality of electrodes 22 on at least one carrying rod 211, there are two first electrodes 22a arranged adjacently.
  • any pair of first electrodes 22a are used to form a mapping electrode pair for mapping.
  • the two first electrodes 22a on the same carrying rod 211 are combined as a mapping electrode pair for mapping, but in other embodiments, two first electrodes 22a arranged on different carrying rods 211 can also be used as a mapping electrode pair.
  • the arrangement of electrodes 22 in this embodiment is that No. 1 electrode 22 and No. 2 electrode 22 on the carrying rod 211 are used as the first electrode 22a, or No. 2 electrode 22 and No. 3 electrode 22 on the carrying rod 211 are used as the first electrode 22a.
  • the No. 2 electrode 22 and the No. 3 electrode 22 are used as the first electrode 22a, wherein the first electrode 22a includes the No. 3 electrode 22 located at the outermost end 2111 of the bearing rod 211, which has the advantage of good adhesion.
  • two first electrodes 22a are arranged on all the bearing rods 211, and the total number of first electrodes 22a is twelve, which can form six pairs of mapping electrodes, increasing the number to improve the accuracy of mapping.
  • the distance between two adjacent first electrodes 22a is fixed in this way during the change of the radial dimension of the support frame 21, the far-field interference is also fixed and the electric field interference is small, and the mapping accuracy is higher.
  • all the three or more electrodes 22 on at least one carrying rod 211 are the first electrodes 22a.
  • any pair of first electrodes 22a are used to form a mapping electrode pair for mapping.
  • all the electrodes 22 on the carrying rod 211 are the first electrodes 22a, correspondingly, the ablation device will have eighteen first electrodes 22a, and the increase in the number can effectively improve the mapping accuracy.
  • mapping methods can be formed respectively by setting different first electrodes 22a.
  • Each first electrode 22a and a corresponding first terminal 32a in the connector 3 can form a one-to-one electrical connection with reference to the example of FIG.
  • the ablation device can also include reference electrodes 6, each of which is electrically connected to one of the conductive terminals 32 of the connector 3; the reference electrodes 6 can be located on the outer tube 1 or the puller 4, and the reference electrodes 6 and the first electrodes 22a can form a mapping electrode pair.
  • a reference electrode 6 may also be provided at the farthest end of the support frame 21 , and the reference electrode 6 and the first electrode 22 a on the carrying rod 211 form a mapping electrode pair.
  • a reference electrode can also be provided on the body surface, and a mapping electrode pair is formed by the reference electrode and a first electrode 22a on the ablation device.
  • the support frame 21 of the ablation assembly 2 is stored in the sheath tube in a contracted state. After the ablation assembly 2 is transported to a predetermined position in the human body through the sheath tube, the sheath tube is withdrawn, the support frame 21 is released, and the support frame 21 is attached to the target ablation area.
  • the connector 3 can be used to connect to an external mapping device, and the first electrode 22a is used for mapping through the first terminal 32a.
  • the connector 3 is switched and connected to an external ablation energy source, and the ablation energy is transmitted to the electrode 22 through the conductive terminal 32, and the electrode 22 performs pulse ablation or other energy forms of ablation on the target ablation area.
  • the connector 3 can be switched and connected to an external mapping device again, and the first electrode 22a is used for mapping again. It can be understood that, according to actual conditions, mapping and ablation can be performed alternately.
  • the degree of expansion of the supporting frame 21 can be adjusted by manipulating the traction member 4 so as to fit the human tissue better.
  • the bearing rod 211 in the support frame 21 extends in a helical shape from its proximal end to its distal end.
  • the spiral form of the bearing rod 211 can be obtained by heat setting after cutting, or by other feasible technical means.
  • the proximal end and the distal end of the carrying rod 211 are deflected by a preset angle ⁇ in the circumferential direction, preferably, the preset angle ⁇ ranges from 30 degrees to 70 degrees.
  • the helix angle (ie twist angle) of the bearing rod 211 at different positions may be different.
  • the carrier bar 211 has a middle position between its proximal and its remote end.
  • the spiral angle of the bearer 211 at the middle position is greater than the spiral angle of the bearer 211 at the spiral angle at its proximity or its remote end.
  • the partial rotation, and the load rod 21 is deflected from a large angle at a large angle at the axial extension at the axial extension at the middle position.
  • the helix angle of the bearing rod 211 gradually decreases from the middle position to the proximal end of the bearing rod 211 or the distal end of the bearing rod 211 .
  • middle position refers to the non-end position of the bearing rod 211 , and may not refer to a specific position.
  • the helix angles of the bearing rod 211 are distributed symmetrically on both sides of the midpoint.
  • the projection of the bearing rod 211 on a plane perpendicular to the axis L of the outer tube 1 is symmetrical.
  • the projected shape of the carrying rod 211 may also be an ellipse, an arc or other symmetrical geometric shapes.
  • a plurality of bearing rods 211 supporting the frame 21 are evenly distributed on the circumferential positions of the traction member 4 .
  • the projections of two adjacent bearing rods 211 on a plane perpendicular to the axis L of the outer tube 1 may partially overlap, or may not overlap at all.
  • the helical extension structure of the bearing rod 211 can have a longer fitting length with the target ablation area in the circumferential direction, so that the ablation assembly 2 has better compliance and closely adheres to the target ablation area.
  • Each bearing rod 211 is provided with a plurality of mutually spaced electrodes 22 along its axial direction.
  • the plurality of electrodes 22 correspond to each other in the axial direction and are arranged at intervals around the axis L of the outer tube 1 in the circumferential direction.
  • Each electrode 22 can be used as an ablation electrode, or can be used as a mapping electrode by forming a one-to-one electrical connection with the first terminal 32 a of the connector 3 .
  • the illustration of the connector 3 is omitted in the ablation devices shown in FIGS. 2 to 4 , and the first embodiment can be referred to for the connection method between the electrodes 22 and the connector 3 .
  • the electrodes 22 implement the ablation function and the mapping function reference may also be made to the first embodiment, which will not be repeated here.
  • the support frame 21 further includes a positioning frame 213, the proximal end of the positioning frame 213 is connected to the distal ends of a plurality of bearing rods 211, and the distal end of the positioning frame 213 is connected to the distal end of the traction member 4; when the supporting frame 21 is fully expanded, the radial dimension of the positioning frame 213 is smaller than the radial dimension of the frame surrounded by the plurality of bearing rods 211.
  • the positioning frame 213 and the plurality of bearing rods 211 can be formed by integrally cutting and shaping nickel-titanium tubes.
  • the radial dimension of the positioning frame 213 refers to the dimension of the positioning frame 213 along the axial direction of the vertical traction member 4 .
  • the positioning frame 213 can transmit the external force to another bearing rod 211 adjacent to the bearing rod 211 that is subjected to the external force, thereby pulling the adjacent bearing rod 211.
  • the bearing rods 211 have the ability to maintain their own structure and state, so that a reverse force is formed on the adjacent bearing rods 211 to buffer or counteract the force.
  • the adjacent bearing rods 211 generate a reaction force perpendicular to the axis or inclined to the axis against the bearing rods 211 subjected to the external force to resist the external force, so that the distance between adjacent bearing rods 211 can be kept, the position of the bearing rods 211 is kept stable, and the relative position of the electrodes 22 on the bearing rods 211 is effectively maintained. 22 are in contact with each other to short-circuit, effectively avoiding the breakdown damage to the tissue and reducing the occurrence of serious adverse complications.
  • the positioning frame 213 includes a plurality of main rods 2131 and a plurality of sub-rods 2132; a plurality of main rods 2131 are arranged along the circumferential direction of the traction member 4, and the distal end of each main rod 2131 is connected to the distal end of the traction member 4, and the proximal end of each main rod 2131 is connected to the distal ends of a plurality of sub-rods 2132; Different main rods 2131 are connected.
  • Different bearing rods 211 connected by the same main rod 2131 and multiple sub-rods 2132 can be connected to each other through corresponding main rods 2131 and corresponding sub-rods 2132 to disperse the stress on the respective bearing rods 211, for example, the stress on a single bearing rod 211 can be dispersed to other bearing rods 211 connected to the corresponding main rod 2131.
  • each main rod 2131 is connected to the distal ends of two sub-rods 2132, and the two sub-rods 2132 connected to the same main rod 2131 extend in directions away from each other, and the proximal ends of the two sub-rods 2132 connected to the same main rod 2131 are connected to the distal ends of two adjacent load-bearing rods 211.
  • the external force received by a single bearing rod 211 is transmitted to two adjacent bearing rods 211 through the branch rod 2132 .
  • the sub-rods 2132 pull the main rod 2131 from the axial and radial directions, so that the deformation of the main rod 2131 in the radial direction and the axial direction will not be too large, which is beneficial to the positioning frame 213 to maintain the basket shape, so that in the process of changing the radial size of the support frame 21, it can make
  • the ablation device maintains a better centering effect, and can be accurately aligned around the pulmonary vein ostium when the ablation device is used for circular ablation at the pulmonary vein ostium.
  • a plurality of sub-rods 2132 are connected end to end to form a wave-shaped ring structure surrounding the traction member 4 , the proximal end of each main rod 2131 is connected to the peak of the wave-shaped ring structure, and the distal end of each bearing rod 211 is connected to the wave-shaped trough of the wave-shaped ring structure. Therefore, the external force received by the bearing rod 211 can be transmitted through the corrugated ring structure formed by these sub-rods 2132 .
  • connection between the main rod 2131 and the sub-rod 2132 is bent toward a side away from the traction member 4
  • the connection between the load-carrying rod 211 and the sub-rod 2132 is bent toward a side close to the traction member 4 .
  • the far end of the bearing rod 211 is formed with a turned-up portion 2113
  • the turned-up portion 2113 is formed by bending the farthest end of the bearing rod 211 in a direction close to the axis of the traction member 4 and extending to the proximal end.
  • the turned-up portions 2113 of the plurality of bearing rods 211 are respectively connected to the distal ends of the traction member 4 , and the outline of the support frame 21 is roughly spherical or cage-like.
  • the advantage of the design of the supporting frame 21 in this embodiment is that, on the one hand, since the overall shape of the supporting frame 21 is spherical or cage-shaped, the arc or spherical structure on the surface of the spherical or cage-shaped supporting frame 21 is easy to ablate, and then the supporting frame 21 can be easily positioned at the target ablation area at any angle, so that the ablation device can be used for dotted line ablation or circular ablation.
  • the structural design of the turned-up portion 2113 enables the distal end of the traction member 4 to be located within the axial contour range of the bearing rod 211, which can avoid device damage to the atrial tissue due to the protrusion of the distal end of the traction member 4 and produce a tip, and better conform to the ablation area of the heart.
  • the length of the turned-up portion 2113 can be set according to needs, and the shape of the distal end of the support frame 21 can be changed so as to adapt to different target ablation areas.
  • the turn-up portion 2113 can be clamped in the tubular structure of the traction member 4 .
  • Each bearing rod 211 is provided with a plurality of electrodes 22 spaced from each other along its axial direction, wherein at least one bearing rod 211 is provided with an electrode 22 at its most distal end, so that the electrode 22 is arranged at the most distal end of the supporting frame 21, so that the ablation device can perform focal ablation.
  • each carrying rod 211 is provided with an electrode 22, and preferably, the most distal electrode 22 of each carrying rod 211 and the electrode 22 adjacent to the most distal electrode 22 are set as the first electrode 22a, and the first electrode 22a can be used for both ablation and mapping.
  • each bearing rod 211 of the supporting frame 21 are connected to the outer circumference of the traction member 4, and the tangent line of the distal end of each bearing rod 211 is perpendicular to the axis of the traction member 4, so that the distal ends of a plurality of bearing rods 211 are combined to form an arc or circular structure.
  • a plurality of insertion holes 41 are provided on the outer periphery of the traction member 4 , and each insertion hole 41 is correspondingly inserted into a distal end of a bearing rod 211 , so that each bearing rod 211 is connected to each insertion hole 41 one-to-one.
  • the end of the bearing rod 211 connected with the traction member 4 is the farthest end of the bearing rod 211 , and the farthest end of the traction member 4 is smoothly or roundly connected with the farthest end of the bearing rod 211 .
  • the distal end of the ablation device also has no protruding tip, which avoids device damage to the atrial tissue and better conforms to the ablation area of the heart.
  • the traction member 4 includes a traction rod 43 and a connector 44 arranged at the distal end of the traction rod 43 , each bearing rod 211 is connected to the outer periphery of the connector 44 , the tangent line of the distal end of the bearing rod 211 is approximately perpendicular to the axis of the connector 44 , and the distal end of the connector 44 is approximately tangent to or forms a relatively smooth transition with the distal ends of a plurality of bearing rods 211 .
  • the distal end surface of the connecting head 44 and the distal end surface of the support frame 21 are roughly in the same sectional plane, and the outline of the support frame 21 can be roughly spherical or cage-shaped. Therefore, the overall abutment of the support frame 21 is relatively stable and can be ablated at any angle. It can be well adapted to the dotted line ablation of the atrial wall, mitral valve isthmus, and tricuspid valve isthmus, and can achieve the goal of overall rapid, efficient and quality ablation.
  • the connector 44 can be used as an ablation electrode or a mapping electrode and other electrodes with mapping and ablation performance, which fully improves the usability of the connector 44, thereby systematically enhancing the usability of the ablation device.
  • the connecting head 44 is used as an ablation electrode, since the distal end surface of the connecting head 44 and the distal ends of the multiple bearing rods 211 are approximately tangent or have a relatively rounded transition, the electrodes 22 provided at the distal ends of the connecting head 44 and the multiple bearing rods 211 can be placed on the same ablation spherical surface or ablation arc surface, thereby achieving the overall goal of rapid, efficient and quality ablation.
  • the connector 44 when used as an ablation electrode, it can perform ablation as a radiofrequency ablation function, or as a pulse ablation. The operator can adjust the targeted ablation strategy according to the different conditions of the patients, and can expand the ablation range of the lesion, so as to meet the ablation requirements of more indications.
  • the connector 44 When the connector 44 is used as a mapping electrode, the connector 44 can form a one-to-one connection with a conductive terminal 32 of the connector (not shown in the figure) through a wire alone, and the connector 44 can be well attached to the surface of the myocardium, which is conducive to improving the mapping accuracy.
  • the connecting head 44 can be used as a mapping electrode alone, and at the same time, the connecting head 44 can also form a mapping electrode pair together with the first electrode 22a on the carrying rod 211 .
  • the first embodiment may be referred to for the arrangement of the electrodes 22 on the bearing rod 211 and the specific manners for the electrodes 22 to realize the ablation function and the mapping function, and details are not repeated here.
  • the support frame 21 further includes a plurality of support rods 215 , and each support rod 215 is used to connect two adjacent bearing rods 211 .
  • One end of each supporting rod 215 is connected to one of the supporting rods 211 , and the other end is connected to another adjacent supporting rod 211 .
  • the support rod 215 extends obliquely, and its two ends have an interval along the axial direction of the outer tube 1 .
  • the adjacent bearing rods 211 can be restrained by the support rods 215, so that the distance between the adjacent bearing rods 211 can be maintained, the ablation device can be prevented from being offset when the bearing rods 211 are working, and the electrodes 22 on the adjacent bearing rods 211 can be prevented from contacting each other to cause a short circuit, thereby avoiding the generation of electric arcs.
  • the support rods 215 improve the uniformity of distribution of the bearing rods 211 in the circumferential direction, so that the overall support frame 21 is not easy to be twisted and deformed, and the accuracy and efficiency of ablation and mapping performed by the ablation device are improved.
  • a support rod 215 is arranged on both sides of the same load rod 211, and the support rods 215 on both sides of the load rod 211 are arranged to extend toward the far end or toward the proximal end to connect to another adjacent load rod 211, that is, the two support rods 215 arranged on both sides of the same load rod 211 extend away from each other.
  • the support rods 215 arranged on both sides of the same load rod 211 are asymmetrical with respect to the load rod 211, that is, the connection positions of the two support rods 215 arranged on both sides of the load rod 211 on the load rod 211 have an axial distance.
  • One ends of the two support rods 215 are connected to different positions of the same load rod 211 , and the other ends extend in directions away from each other.
  • This asymmetric structure is beneficial to improve the stability of the overall spherical shape of the support frame 21 , the controllability of the arc of the sphere, the stability of the entire sphere structure, and the difficulty of deformation of the sphere frame.
  • the position of the support rod 215 is not limited, and the support rod 215 can be arranged at the middle position of the bearing rod 211, or at the distal position of the bearing rod 211, or at the proximal position of the bearing rod 211.
  • the first embodiment may be referred to for the arrangement of the electrodes 22 on the bearing rod 211 and the specific manners for the electrodes 22 to realize the ablation function and the mapping function, and details are not repeated here.
  • the difference between this embodiment and the seventh embodiment is that, as shown in FIG. 12 , in this embodiment, the supporting rods 215 arranged on both sides of the same bearing rod 211 are arranged symmetrically with respect to the bearing rod 211 .
  • the supporting rods 215 disposed between two supporting rods 211 among the plurality of supporting rods 211 form a substantially continuous V-shaped or W-shaped ring structure.
  • the annular structure enables multiple supporting rods 215 to support and lean against each other, thereby constraining each supporting rod 211 in the axial and circumferential directions, improving the stability of the shape of the supporting frame 21, and thus improving the accuracy of ablation and mapping.
  • the first embodiment may be referred to for the arrangement of the electrodes 22 on the bearing rod 211 and the specific manners for the electrodes 22 to realize the ablation function and the mapping function, and details are not repeated here.

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Abstract

一种消融装置，包括：外管（1）；消融组件（2），其设于外管（1）的远端，包括沿径向可收缩和膨胀的支撑骨架（21）和设置在支撑骨架（21）上的多个电极（22）；其中，多个电极（22）中具有至少一个能够用于标测的第一电极（22a）；连接器（3），其设于外管（1）的近端，连接器（3）包括多个导电端子（32），连接器（3）通过多个导电端子（32）与多个电极（22）形成电连接，多个导电端子（32）中具有至少一个第一端子（32a），每一第一端子（32a）与对应的一个第一电极（22a）形成一对一电连接，以在连接器（3）连接至外部标测设备（300）时，第一电极（22a）通过第一端子（32a）能够用于标测。消融装置同时具备标测和消融的功能，可提高操作便捷性。

Description

消融装置
本申请要求提交中国国家知识产权局、申请号为202210077700.5(申请名称为“消融装置”)的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及医疗器械技术领域，特别涉及一种消融装置。
背景技术
电生理标测在电生理领域具有非常重要的作用，电生理标测用于记录体内的电生理信号，据此发现异常发生的病灶并指导消融，在执行消融治疗后再通过标测验证治疗的效果。
现有的电生理标测一般是利用标测导管来实现，同时利用消融导管完成消融治疗，这也就导致了在手术过程中需要将多个装置插入患者的身体中并从患者的身体中移除。例如，在手术过程中，使用标测导管来进行电生理标测，一旦完成标测，就可以移除标测导管，并在其位置插入消融导管，在消融结束后，再插入标测导管进行标测，以验证消融治疗的效果。然而，在手术过程中需要分别引导消融导管和标测导管两个装置，会导致手术操作步骤复杂，手术时间长、成本高等诸多缺陷。
发明内容
为了解决上述问题，本发明提供一种消融装置，包括：外管；消融组件，其设于所述外管的远端，包括沿径向可收缩和膨胀的支撑骨架和设置在所述支撑骨架上的多个电极；其中，多个所述电极中具有至少一个能够用于标测的第一电极；连接器，其设于所述外管的近端，所述连接器包括多个导电端子，所述连接器通过多个所述导电端子与多个所述电极形成电连接，多个所述导电端子中具有至少一个第一端子，每一所述第一端子与对应的一个所述第一电极形成一对一电连接，以在所述连接器连接至外部标测设备时，所述第一电极通过所述第一端子能够用于标测。
本发明实施例中的消融装置，通过可径向膨胀的支撑骨架以及设置在支撑骨架上的多个电极而可对目标消融区域进行消融；同时，这些电极中具有与连接器上的第一端子形成一对一连接的第一电极，从而在通过连接器连接外部标测设备时，通过对应的第一端子而使得第一电极还能够用于电生理标测，使得消融装置同时具备了标测和消融的功能，手术操作更加便捷，便于提高手术效率。
附图说明
图1a是本发明第一实施例的消融装置的示意图。
图1b是连接器安装在手柄上的示意图。
图1c是连接器与外部消融能量源或外部标测设备相连接的示意图。
图1d是消融装置的牵引件上设有参考电极的示意图。
图1e是消融装置的支撑骨架的远端设有参考电极的示意图。
图2是本发明第二实施例的消融装置的示意图。
图3是图2的俯视图。
图4是图2的支撑骨架沿轴向压缩变形的状态示意图。
图5是本发明第三实施例的消融装置的示意图。
图6是图5中A处局部放大图。
图7是图5的俯视图。
图8是本发明第四实施例的消融装置的示意图。
图9是本发明第五实施例的消融装置的示意图。
图10是本发明第六实施例的消融装置的示意图。
图11是本发明第七实施例的消融装置的示意图。
图12是本发明第八实施例的消融装置的示意图。
附图标记说明如下：
1、外管；
100、手柄；
200、外部消融能量源；
300、外部标测设备；
2、消融组件；21、支撑骨架；211、承载杆；2111、最外端；2113、反包部；213、定位框；2131、主杆；2132、分杆；215、支撑杆；22、电极；22a、第一电极；22b、第二电极；
3、连接器；31、绝缘壳体；32、导电端子；32a、第一端子；32b、第二端子；
4、牵引件；41、插孔；43、牵引杆；44、连接头；
5、导线；
6、参考电极。
具体实施方式
体现本发明特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本发明能够在不同的实施方式上具有各种的变化，其皆不脱离本发明的范围，且其中的说明及图示在本质上是当作说明之用，而非用以限制本发明。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个所述特征。在本申请的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
本发明实施例提供一种具有标测功能的消融装置，其可以用于心脏消融，通过采用经皮穿刺的方式可以输送到心脏特定的位置，再利用脉冲电场、射频或微波等外部消融能量源对肺静脉、左心耳，或者合并有典型心房扑动、非肺静脉起源的触发灶(如上腔静脉、冠脉静脉窦口)等进行消融，达到电隔离的效果。可以理解的是，心脏消融是消融装置的一种典型应用，而在可行的情况下，消融装置也可以作用于其他机体组织，在此不做限定。
其中，该消融装置上设有用于消融的电极，而在消融前后还可以直接利用其上的电极进行电生理标测，使得消融装置同时具备了标测和消融的功能，手术操作更加便捷，有利于提高手术的成功率。
为更好地理解本发明的方案，本文将通过多个实施例进行详细介绍。需要说明的是，在不冲突的情况下，本发明的各个实施例中的特征可以相互结合。
为便于表述，对本文中涉及的若干术语定义释义如下：
近端和远端：在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的靠近操作者的一端称为“近端”，将远离操作者的一端称为“远端”，本文中依据此原理定义消融装置中的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向，“径向”一般是指医疗器械的与其“轴向”垂直的方向，“周向”一般是指环绕“轴向”的方向，本文依据此原理定义消融装置的相关部件的“轴向”、“径向”和“周向”。该等定义，只是为了表述方便，并不构成对本申请的限制。如有例外情形，可以结合附图和本领域技术人员的通常理解做出合理的解释。
绝缘层：在某部件的表面进行绝缘处理而形成，用于使部件该部分绝缘。具体地，绝缘层形成的方式有：在需进行绝缘处理的位置涂覆绝缘涂层材料，涂层材料包括但不限于派瑞林涂层、PTFE(Poly-tetra-fluoroethylene，聚四氟乙烯)涂层、PI(Polyimide，聚酰亚胺)涂层；或者，在需进行绝缘处理的位置覆盖绝缘膜，膜材料包括但不限于FEP(Fluorinated-ethylene-propylene，全氟乙烯丙烯共聚物)、PU(polyurethane，聚氨基甲酸酯)、ETFE(Ethylene-tetra-fluoro-ethylene，乙烯-四氟乙烯共聚物)、PFA(Polyfluoroalkoxy，四氟乙烯—全氟烷氧基乙烯基醚共聚物)、PTFE、PEEK(Poly-ether-ether-ketone，聚醚醚酮)、硅胶；或者，在需进行绝缘处理的位置穿套绝缘套管，绝缘套管的材料包括但不限于FEP、PU、ETFE、PFA、PTFE、PEEK、硅胶。
脉冲消融：利用高强度的脉冲电场使细胞膜发生不可逆电击穿，在医学领域称之为不可逆电穿孔(Irreversible electroporation，IRE)，使细胞凋亡从而实现非热效应消融细胞，所以不受热沉效应影响。高电压脉冲序列产热少，不需要生理盐水冲洗来冷却，可有效减少气爆、焦痂和血栓的发生。脉冲消融治疗时间短，施加一组脉冲序列的治疗时间不到1分钟，全程消融时间一般不超过5分钟。且由于不同组织对脉冲电场的反应阈值存在差异，为消融心肌而不干扰其他临近组织提供了可能，从而可避免误伤临近的组织。另外，相较于其他能量，脉冲消融不需要热传导来对深层组织消融，所有分布在一定电场强度之上的心肌细胞均会发生电穿孔，降低了消融时对导管贴靠压力的要求。因此即使消融器械没有完全地贴合组织内壁，也不影响IRE消融效果。
第一实施例：
参阅1a，本实施例的消融装置主要包括外管1、设于外管1的远端的消融组件2，以及设于外管1的近端的连接器3。本实施例中，该消融装置还进一步地包括穿设在外管1内并连接消融组件2的牵引件4。该消融装置可以通过输送装置输送到心脏内部，输送装置大致上可以包含鞘管、手柄等，有关输送装置的具体构成可以参照本领域的相关技术。其中，该消融装置的连接器3可以是设置在手柄100上，如图1b所示。
请再次参阅图1a，外管1为中空的管状结构，其轴线L沿远端和近端的方向延伸。外管1内具有单个轴向管腔或中心管腔(图中未示出)。根据实际需要，外管1也可以构造为具有多个管腔，以通过多个管腔分别容纳拉线、引线、传感器电缆以及在特定应用中可能需要的任何其它电线、电缆和/或管等结构。
可以理解的是，外管1还可以任何合适的构造，并且可以由任何合适的材料制成，例如一种构造包括由聚氨酯或PEBAX(Polyether-block-amide，聚醚嵌段酰胺)等高分子材料制成的外壁。外管1具有一定的柔性，能够弯曲以适应心脏内部的弯曲结构。
消融组件2包括沿径向可收缩和膨胀的支撑骨架21和设置在支撑骨架21上的多个电极22。
支撑骨架21的近端连接外管1的远端，支撑骨架21的远端朝向外管1的轴线L方向收拢，其中本实施例中，支撑骨架21的远端收束在牵引件4的远端。图1a示意了支撑骨架21呈膨胀状态的结构，此时，支撑骨架21的两端收拢中部膨开，支撑骨架21的外形轮廓大致呈网篮形。支撑骨架21还可以是其他构造，例如球形，蛋形，南瓜形，灯笼形，椭圆形等。
在图1a所示意的结构基础上，支撑骨架21可以相对于外管1的轴线L沿径向向内收缩，也即支撑骨架21的中部也向外管1的轴线L方向收拢，支撑骨架21在收缩状态下将伸直为大致呈线形状态。支撑骨 架21在收缩状态下的轴向长度将大于其在膨胀状态下的轴向长度。
在收缩状态下，支撑骨架21可以收容于鞘管内，以方便地通过鞘管输送到人体内。而在通过鞘管达到目标消融部位时，支撑骨架21从鞘管中释放，再沿径向膨胀为图1a所示的膨胀状态。
支撑骨架21沿径向膨胀可以是在其伸出鞘管时自膨胀而撑开，或者支撑骨架21在伸出鞘管后，在人为的操控干预下径向膨胀。例如本实施例中可以利用牵引件4对支撑骨架21的收缩和膨胀进行控制，下文将具体介绍。
支撑骨架21可以采用弹性金属制成的管材切割制成，也可以采用弹性金属丝材编织而成，或者局部编织结合局部管材切割的方式加工，不同加工方式获得的部位可以焊接或通过连接件相互固定。管材的材料为金属或者非金属材料，优选记忆金属材料或镍钛合金材料。在本实施例中，支撑骨架21可由一根镍钛合金管材切割定型而成。
具体地，支撑骨架21包括绕外管1的轴线L周向排列的多个承载杆211；该多个承载杆211围合形成呈沿径向可收缩和膨胀的结构。本实施例中，承载杆211绕外管1的轴线L周向设置为六根，承载杆211沿周向均匀布置。在其他实施例中，承载杆211的数量可以是四、五、六、七、八、九、十、十一、十二或任何其它合适的数量。承载杆211可以均匀地或非均匀地周向间隔分布。
各个承载杆211的近端均与外管1的远端相连，多个承载杆211的远端向外管1的轴线L方向收拢。本实施例中，各个承载杆211的远端连接在牵引件4上，并可以在牵引件4的操控下使得支撑骨架21收缩或膨胀。
牵引件4同轴穿设于外管1内，牵引件4的远端朝向远端伸出外管1的远端并连接各个承载杆211的远端。牵引件4能够相对于外管1沿轴向移动，从而带动支撑骨架21沿径向膨胀或收缩。
牵引件4的近端可以与手柄100连接，手柄100牵拉牵引件4而带动牵引件4沿轴向移动。当牵引件4由远端向近端方向相对外管1移动时，各个承载杆211的远端随着牵引件4向近端移动，承载杆211的中部将沿径向向外逐渐撑开，从而支撑骨架21的外径将增大，也即向外膨胀。反之，当牵引件4由近端向远端方向相对外管1移动时，各个承载杆211的远端随着牵引件4向远端移动，承载杆211被拉直，承载杆211的中部沿径向往外管1的轴线L逐渐靠拢，从而支撑骨架21的外径将减小。由此，通过牵引件4可以灵活调节支撑骨架21的外径，使支撑骨架21能够适应不同直径大小的血管(例如肺静脉)或其它机体组织，并能够在任意适当外径尺寸的条件下对目标消融区域进行消融，而非支撑骨架21必须限定在轴向压缩程度最大(即径向膨胀程度最大)的情形下进行消融，这提高了支撑骨架21对不同目标消融区域解剖形态的适应性，方便了消融装置的操作，消融效果更好。
牵引件4可以为钢缆、柔性聚酰亚胺(PI)管，氟代聚乙烯(PDFE)管，不锈钢管，或者其他高分子材料制成的管件。在牵引件4为管状结构时，牵引件4具有一定的结构强度，从而能够起到缓冲承载杆211受到的外力，能够有效的保证承载杆211位置的稳定性。
在一些实施例中，消融装置也可以不设置牵引件4，支撑骨架21采用自膨胀的方式沿径向膨胀，此时，支撑骨架21的直径大小不可调，可以适用于固定大小区域的消融目标。
多个电极22分别设置在支撑骨架21的各个承载杆211上。在支撑骨架21径向膨胀后，各个承载杆211可以贴合心脏内部的组织内壁，电极22利用消融能量进行组织消融。需要说明的是，电极22设置于支撑骨架21上，支撑骨架21的径向膨胀的过程中，电极22随着支撑骨架21的膨胀而可能在径向的位置发生改变。
本实施例中，每一承载杆211上均沿轴向间隔设有多个电极22。在多个承载杆211中，电极22沿轴向一一对应，并环绕外管1的轴线L呈周向间隔布置。在其他实施例中，也可以是仅在部分的承载杆211上设置一个或多个电极22。
示例性地，本实施例的每一承载杆211上设有三个电极22，可以理解的是，电极22的数量也可以根 据实际情况合理设定。将承载杆211的沿径向最远离外管1的轴线L的位置称为最外端2111，本实施例的各个电极22布置在承载杆211的远端和最外端2111之间，从而可以保证电极22之间的距离在比较合适的范围而避免产生电弧，同时保证电极22能够较好地顺应心房组织并保持良好的贴壁性。其中一电极22位于最外端2111处。
电极22可以是环状电极，也可以是片状电极、点状电极或者球形电极等，本实施例不做具体限定。电极22可以采用铂铱合金、黄金、其他铂合金、不锈钢、镍钛或其他任何具有生物相容性的医用金属制成。
每个电极22的内壁焊接有一根具有绝缘层的导线5，承载杆211包括杆体以及套设于杆体外部的绝缘套管，绝缘套管的材料为PEBAX管或者其他高分子绝缘材料，保证了电极22与杆体之间的绝缘性。绝缘套管可以为一层、两层或者多层，在此不作限定。杆体的截面形状可以为椭圆形、圆形、矩形、半圆形、圆鼓或者其他形状，在此不做限定。本实施例中，杆体由镍钛丝制成，使得杆体具有优良的弹性性能及强度，以能够很好地与目标消融区域贴靠。可以理解，杆体也可以由其他材料制成，例如不锈钢或者高分子材料。
电极22套在承载杆211的绝缘套管上，保证了电极22与杆体之间的绝缘性，导线5安放在杆体与绝缘套管之间，即每一个电极22内表面通过一导线5从绝缘套管表面穿过，并顺着承载杆211和外管1连接到连接器3，电极22与导线5之间通过焊接或者其他特殊工艺连接。
连接器3大致包括绝缘壳体31和设置在绝缘壳体31上的多个导电端子32。通过绝缘壳体31可以将连接器3安装在手柄100上。多个导电端子32的排布方式可以依据实际情况设定，不限于采用图1a所示的排列方式。导电端子32的结构形式不限，可以是实心针状端子、pogo pin等。
该多个导电端子32通过导线5与消融组件2的多个电极22形成电连接，导线5与导电端子32可以焊接连接。通过这些导电端子32，连接器3可以选择性地连接至外部消融能量源200(如图1c所示)或外部标测设备300(如图1c所示)。在连接器3连接外部消融能量源200时，消融能量可以借由导电端子32和导线5传递至电极22，从而电极22可用于消融。在连接器3连接外部标测设备时，满足标测要求的电极22可以经导线5和导电端子32向外传送采集到的电生理信号。
图1a中未示出多个导电端子32与多个电极22之间的完整连接关系，依据电极22的不同功能，导电端子32与电极22可能具有不同的对应连接关系。举例说明如下：
消融组件2的多个电极22中具有至少一个第一电极22a，第一电极22a能够用于标测。该第一电极22a在需要消融时用于消融，而在消融前后用于标测。图1a中示例性地标出了两个第一电极22a，这两个第一电极22a分别设置在两个承载杆211上。与这两个第一电极22a相对应地，连接器3的多个导电端子32中具有两个第一端子32a，每一第一端子32a与对应的一个第一电极22a形成一对一电连接，即一个第一端子32a仅与一个第一电极22a通过对应的一导线5相连接，每一第一端子32a不会连接其他的电极22。在此条件下，每一第一电极22a所采集到的电生理信号经第一端子32a传递出来后，可以清楚唯一地反映出人体内特定位置处也即该第一电极22a所在位置处的电生理状态，因此可以准确地进行电生理标测，该第一电极22a即可通过对应的第一端子32a而能够用于标测。第一电极22a的数量及设置方式可以有多种，并不限于图1a中所标出的这两个。
此外，由于第一电极22a与第一端子32a是采用一对一电连接的方式，在连接器3连接外部消融能量源200(如图1c所示)时，还可以对第一端子32a进行单独控制以使对应的第一电极22a通电或断电，在第一电极22a通电时即可对该第一电极22a所在的区域进行局部消融，而无需限定为必须对整个目标消融区域进行消融。由此，该消融装置能够实现分区消融。通过分区域局部消融能够避免损伤到非预期消融的组织。消融能量可以针对性地作用到需要消融的组织，增加消融能量的利用率，减少消融能量在血液中的耗散，减少电解血液产生的不必要的气泡。在分区消融时，无需对所有电极22进行通电，减小消融时的 总电流而降低可能的机体刺激，还能降低因电极22过多导致的短路或电弧，提高安全性。
在本申请的一些实施方式中，在连接器3与外部消融能量源200连接时，第一电极22a能够通过第一端子32a进行单独控制以放电，进而使得被控制放电的第一电极22a能够向其所在的区域传递外部消融能量源200输出的消融能量以进行局部消融。
本实施例中，消融组件2的多个电极22中还具有仅用于消融的多个第二电极22b。图1a中示例性地标出了两个第二电极22b，这两个第二电极22b分别设置在两个承载杆211上。而连接器3的多个导电端子32中具有同时与这两个第二电极22b电连接的一个第二端子32b，即两个第二电极22b通过各自对应的导线5均连接到这一第二端子32b上，从而在消融时，该第二端子32b所连接的这两个第二电极22b将具有同样的极性。
第二电极22b的数量并不限于为图1a所示的两个，还可以具有更多，而第二端子32b的数量少于或等于第二电极22b的数量。其中，当第二端子32b的数量少于第二电极22b的数量时，既可以按照图1a的连接方式将多个第二电极22b电连接至同一第二端子32b，从而可以减少第二端子32b的数量。而当第二端子32b的数量等于第二电极22b的数量时，可以利用第二端子32b分别对各个第二电极22b按照需求赋予不同的极性，利于形成不同的电场分布以适应不同的消融需求，此时，第二端子32b实际上也可以与第二电极22b进行一对一连接，这种情况下也能实现分区消融。
需要说明的是，以上结合图1a对电极22与导电端子32的连接关系的介绍仅为原理性的示例说明。实际在进行连接时，可以依据电极22的功能，将电极22与导电端子32形成合理的连接关系，并且通过导电端子32来实现电极22的对应功能。
当电极22用于消融功能时，连接器3将所连接的外部消融能量源200的消融能量经导电端子32传递给电极22，由电极22对目标消融区域进行消融。本实施例中，包含第一电极22a和第二电极22b在内的所有电极22均可用于消融。
以外部消融能量源200为脉冲能量为例，电极22接收的脉冲信号的电压范围为500V～3000V，包括其间的所有值和子范围，脉冲频率为500Hz～500kHz，包括其间的所有值和子范围。脉冲能量可以为单极性脉冲高压电源，也可以为双极性高压脉冲电源，双极性高压脉冲信号波形在每个周期内，正负极性脉冲交替。导线5承受的最大电压3000V。全部电极22可被分为一个或者多个正极-负极集合，在一些实施例中，每个承载杆211上的多个电极22可以设置为同一极性，并与相邻的承载杆211上的电极22的极性相反；在另一些实施例中，每一承载杆211上相邻的两个电极22的极性相反，相邻承载杆211上的沿轴向对应的电极22的极性相反；或者，每根承载杆211上相邻电极22的极性相反，相邻承载杆211上的沿轴向对应的电极22的极性相同。电极22接收的能量脉冲包括单相脉冲或双相脉冲，并且各个电极22可以配置不同的电压、脉冲宽度、重复频率、占空比和脉冲个数等参数的单相或双相脉冲。
当电极22用于标测时，连接器3连接外部标测设备300。此时，仅第一电极22a用于标测，第一电极22a采集目标消融区域的电生理信号，再通过第一端子32a传递至外部标测设备300。
第一电极22a的设置以及选择第一电极22a进行标测的方式有多种，以下分别说明。为便于表述，本实施例以每个承载杆211上设置有三个电极22进行举例说明，并将每一承载杆211上的三个电极22从远端至近端依次称为1号电极22、2号电极22以及3号电极22，其中3号电极22位于承载杆211的最外端2111处。
第一种方式：至少两个承载杆211上分别设有一个第一电极22a。
该方式中，在连接器3连接外部标测设备时，将其中任意两个第一电极22a作为标测电极对以用于标测。
其中，承载杆211上的任一电极22均可作为第一电极22a，并且可以是将不同承载杆211上沿轴向对应的电极22作为第一电极22a，即均以承载杆211上的1号电极22作为第一电极22a，或者承载杆211 上的2号电极22作为第一电极22a，或者承载杆211上的3号电极22作为第一电极22a。另外，也可以是将两个承载杆211上轴向不对应的电极22作为第一电极22a，例如，其中一承载杆211上的1号电极22作为第一电极22a，而另一承载杆211上的3号电极22作为第一电极22a。
较佳地，所有的承载杆211上均设置一个第一电极22a，具有更多的可选择性，并且第一电极22a的数量多，还可以提高电生理信号的采集范围和效率，使得标测可以更加准确。
以每一承载杆211上均设置一个第一电极22a为例，在标测时，由相邻两个承载杆211上的第一电极22a组成标测电极对进行电生理标测，例如，由相邻两个3号电极22组成标测电极对。当然，也可以由任意两个第一电极22a作为标测电极对，例如，由任意两个3号电极22作为第一电极22a并组成标测电极对。
特别需要说明的是，较佳地，每一承载杆211上的3号电极22为第一电极22a。相比于1号电极22或者2号电极22作为第一电极22a，由于3号电极22位于承载杆211的沿径向最远离所述外管1的轴线L的位置，也即支撑骨架21膨胀后径向尺寸最大的位置处，因此，在支撑骨架21膨胀后，3号电极22能够与目标消融区域充分贴靠，贴靠性好，更容易标测到电位。
第二种方式：至少一承载杆211上的多个电极22中具有非相邻设置的两个第一电极22a。
该方式中，在连接器3连接外部标测设备时，以任意两两第一电极22a组成标测电极对以用于标测。其中较佳将同一承载杆211上的两个第一电极22a作为一个标测电极对，但在其他实施例中也可以将分列在不同承载杆211上的两个第一电极22a作为一个标测电极对。
相应于本实施例的电极22设置方式，即承载杆211上的1号电极22和3号电极22作为第一电极22a。其中，第一电极22a包含了位于承载杆211最外端2111处的3号电极22，具有贴靠性好的优点。
较佳地，所有承载杆211上均具有两个第一电极22a，从而本方式中，第一电极22a的总数量为十二个，可以组成六对标测电极对，数量增多可以大大提高电生理信号的采集范围和效率，进而使得标测可以更加准确，当整个支撑骨架21贴靠于目标消融区域时，可以采集到多个方向的心电传导信号，使采集到的电位信号更加准确，避免遗漏与记录方向垂直的电位传导。
第三种方式：至少一承载杆211上的多个电极22中具有相邻设置的两个第一电极22a。
该方式中，在连接器3连接外部标测设备时，以任意两两第一电极22a组成标测电极对以用于标测。其中较佳地，将同一承载杆211上的两个第一电极22a并作为标测电极对以用于标测，但在其他实施例中也可以将分列在不同承载杆211上的两个第一电极22a作为标测电极对。
相应地，本实施例的电极22设置方式即为承载杆211上的1号电极22和2号电极22作为第一电极22a，或者承载杆211上的2号电极22和3号电极22作为第一电极22a。
较佳地，以2号电极22和3号电极22作为第一电极22a，其中，第一电极22a包含了位于承载杆211最外端2111处的3号电极22，具有贴靠性好的优点。
该方式中较佳地，也是所有承载杆211上均设置两个第一电极22a，第一电极22a的总数量为十二个，可以组成六对标测电极对，数量增多以提高标测准确性。另一方面，由于在支撑骨架21径向尺寸变化过程中，本方式中相邻两个第一电极22a之间距离固定较小，远场干扰也固定较小，电场干扰小，标测精度更高。
第四种方式：至少一承载杆211上的三个以上的电极22全部为第一电极22a。
该方式中，在连接器3连接外部标测设备时，以任意两两第一电极22a组成标测电极对以用于标测。
本实施例中，较佳地，所有承载杆211上的电极22均为第一电极22a，相应地，消融装置将具有十八个第一电极22a，通过数量的增多可以有效提高标测准确性。
上述所列出的几种方式中，通过设置不同的第一电极22a而可以分别形成不同的标测方式，每一第一电极22a与连接器3中对应的一第一端子32a可以参照图1a的示例分别形成一对一电连接，在此省略各 种方式下有关具体连接的示意图。
除了上述列出的几种方式外，在其他实施例中，如图1d中，消融装置还可以包括参考电极6，每一参考电极6与连接器3的其中一个导电端子32形成一对一电连接；参考电极6可以位于外管1或牵引件4上，参考电极6与第一电极22a能够组成标测电极对。在一些实施例中，如图1e，还可以在支撑骨架21的最远端设置参考电极6，由参考电极6与承载杆211上的第一电极22a组成标测电极对。在有些情况下，还可以在体表设置参考电极，由参考电极与消融装置上的一个第一电极22a组成标测电极对。
本实施例的该消融装置在使用时，消融组件2的支撑骨架21以收缩状态收容在鞘管中，通过鞘管将消融组件2输送到人体预定位置后，撤回鞘管，支撑骨架21释放，支撑骨架21贴靠到目标消融区域，此时可以利用连接器3连接外部标测设备，第一电极22a通过第一端子32a进行标测。标测完成后，连接器3切换连接至外部消融能量源，通过导电端子32将消融能量传递给电极22，由电极22对目标消融区域进行脉冲消融或其他能量形式的消融。在消融后，连接器3可以再切换连接至外部标测设备，再次利用第一电极22a进行标测。可以理解的是，根据实际情况，标测和消融可以交替进行。
另外，对于本实施例中具有牵引件4的结构而言，可以通过操控牵引件4调整支撑骨架21的膨胀程度，以便更好地贴合人体组织。
第二实施例：
本实施例的消融装置与第一实施例的区别在于：参阅图2至图4，本实施例中，支撑骨架21中的承载杆211由其近端向其远端呈螺旋状延伸。
承载杆211的该螺旋形式可以是通过切割后热定型得到，也可以是通过其他可行的技术手段得到。
承载杆211的近端与远端在周向上偏转预设角度α，优选地，该预设角度α范围在30度至70度之间。
承载杆211在不同的位置处的螺旋角(即扭曲角度)可以不同。具体地，承载杆211具有位于其近端和其远端之间的一中间位置，承载杆211在中间位置处的螺旋角大于承载杆211在其近端处的螺旋角或其远端处的螺旋角，即，承载杆211在其近端处和其远端处在沿着轴向延伸的同时以较小角度往周向偏转或者不朝周向偏转，而承载杆211在中间位置处则在沿轴向延伸的同时以较大角度往周向偏转。较佳地，承载杆211的螺旋角从中间位置处向承载杆211的近端处或承载杆211的远端处逐渐减小。
需要说明的是，中间位置是指承载杆211的非端部位置，可以并不特指某一具体位置。
在其中一种优选的实施方式中，承载杆211在各处的螺旋角在中点两侧位置对称分布，参照图3的视图方向，承载杆211在垂直于外管1的轴线L的一平面上的投影呈对称形状，如图3中所示，承载杆211的投影形状大致为具有夹角α的两段直线段和连接在这两段直线段之间的一段圆弧。在其他未示出的实施例中，承载杆211的投影形状还可以是呈椭圆、圆弧或其他呈对称的几何形状。
支撑骨架21的多个承载杆211均匀分布在牵引件4的周向位置。相邻的两个承载杆211在垂直于外管1的轴线L的平面的投影可以有部分重叠，也可以完全不重叠。
本实施例中，承载杆211的这种螺旋状延伸结构可以在周向上与目标消融区域具有更长的贴合长度，从而使得消融组件2有更好的顺应性，紧密贴靠目标消融区域。
每一承载杆211沿其轴向设置有相互间隔的多个电极22，在多个承载杆211中，多个电极22沿轴向一一对应，并环绕外管1的轴线L呈周向间隔布置。
各个电极22可以作为消融电极使用，也可以是通过与连接器3的第一端子32a形成一对一电连接从而能够作为标测电极使用。图2至图4所示的消融装置中省略了连接器3的示意，有关电极22与连接器3的连接方式可以参照第一实施例。另外，关于电极22实现消融功能和标测功能的具体方式也可以参照第一实施例，在此不再赘述。
第三实施例：
本实施例的消融装置与第二实施例的区别在于：参阅图5至图7，本实施例中，支撑骨架21还包括定位框213，定位框213的近端连接多个承载杆211的远端，定位框213的远端连接牵引件4的远端；在支撑骨架21完全膨胀的状态下，定位框213的径向尺寸小于多个承载杆211所围成的框体的径向尺寸。定位框213和多个承载杆211可以利用镍钛管一体切割定型而成。定位框213的径向尺寸是指定位框213在沿垂直牵引件4的轴向方向的尺寸。
在该支撑骨架21中，当承载杆211受到垂直于自身轴线，或倾斜于自身轴线的外力时，定位框213可以将外力传递至与受外力作用的承载杆211相邻的另一承载杆211上，从而对相邻承载杆211牵拉。承载杆211具有保持自身结构和状态的性能，从而在相邻承载杆211上形成反向的作用力以缓冲力或抵消力，相邻承载杆211对受到外力作用的承载杆211产生垂直于轴线或者倾斜于轴线的反作用力，与外力对抗，从而可以使得相邻的承载杆211之间保持间距，保持承载杆211位置的稳定，有效保持承载杆211上的电极22的相对位置的稳定性，防止消融装置在工作时电极22相互接触而短路，有效地避免造成对组织的击穿伤害，减少严重不良并发症的发生。
定位框213包括多个主杆2131和多个分杆2132；多个主杆2131沿牵引件4的周向排布，每一主杆2131的远端连接牵引件4的远端，每一主杆2131的近端连接多个分杆2132的远端；每一承载杆211的远端连接对应的多个分杆2132的近端，且连接同一承载杆211的多个分杆2132的远端连接不同的主杆2131。通过同一个主杆2131和多个分杆2132连接的不同的承载杆211，能够通过对应主杆2131和对应分杆2132相互连接，分散各自承载杆211上的应力，例如，单个承载杆211上的应力，能够分散至对应主杆2131连接的其它承载杆211上。
连接同一主杆2131的多个分杆2132之间具有夹角，以便于能够分别连接多个承载杆211上或其他分杆2132上。
本实施例中较佳地，每一主杆2131的近端连接两个分杆2132的远端，且连接同一主杆2131的两个分杆2132沿相互背离的方向延伸，连接同一主杆2131的两个分杆2132的近端连接相邻的两个承载杆211的远端。相应地，单个承载杆211受到的外力，通过分杆2132传递至相邻的两个承载杆211上。同时，当调整牵引件4与外管1之间的相对位置以带动支撑骨架21收缩或膨胀时，由于相邻两根主杆2131之间通过结合在一起的两根分杆2132进行约束，分杆2132从轴向以及径向上对主杆2131进行牵拉，从而主杆2131在径向上以及轴向上的形变不会太大，有利于定位框213保持网篮状，从而在改变支撑骨架21径向尺寸的过程中，可以使得该消融装置保持较佳的对中效果，当该消融装置用于在肺静脉口部进行环形消融时可以准确地对准肺静脉口部周围。
本实施例中，多个分杆2132首尾相连围合成环绕牵引件4的波形环状结构，每一主杆2131的近端连接波形环状结构的波峰，每一承载杆211的远端连接波形环状结构的波谷。从而承载杆211所受到的外力可以通过这些分杆2132围合成的波形环状结构进行传递。
较佳地，主杆2131与分杆2132的相接处朝远离牵引件4的一侧弯曲，承载杆211与分杆2132的连接处朝靠近牵引件4的一侧弯曲。
本实施例中关于电极22的设置以及通过电极22实现消融功能和标测功能的具体方式可以参照第一实施例，在此不再赘述。
第四实施例：
本实施例与第一实施例的区别在于：如图8所示，本实施例中，承载杆211的远端形成有反包部2113，反包部2113由承载杆211的最远端向靠近牵引件4的轴线的方向弯折并向近端延伸形成，反包部2113连接牵引件4的远端，承载杆211的最远端在往远端的方向上超出牵引件4的远端。多个承载杆211的反包部2113分别连接牵引件4的远端，支撑骨架21的外形轮廓大致呈球状或笼状结构。
由于二尖瓣峡部、三尖瓣峡部、左房顶部的特殊结构和解剖特点的不同，加之心脏环境的生理活动的 影响，使得对这些部位的消融处理对稳定贴靠消融提出了更高的要求。本实施例支撑骨架21的设计的好处在于，一方面，由于支撑骨架21整体外形呈球状或者笼状，球状或笼状结构的支撑骨架21表面的弧形或球形结构易于贴靠消融，进而可以轻松地将支撑骨架21以任意角度贴合定位在目标消融区域，使得消融装置可以用于进行打点划线消融或环形消融，例如在左房顶部、二尖瓣峡部、三尖瓣峡部进行打点划线消融，或者在肺静脉口部进行环形消融；另一方面，反包部2113的结构设计使得牵引件4的远端位于承载杆211的轴向轮廓范围内，可以避免因牵引件4的远端突出产生尖端而对心房组织造成器械损伤，更好顺应心脏消融区域。
反包部2113的长度可以根据需要设置，进而可以改变支撑骨架21的远端的形态，以便于适应不同的目标消融区域。对于牵引件4呈管状结构时，反包部2113可以夹设在牵引件4的管状结构内。
每一承载杆211沿其轴向设置有相互间隔的多个电极22，其中至少一个承载杆211上在其最远端设置有电极22，以使得支撑骨架21的最远端布置有电极22，使得消融装置能够进行局灶消融。
优选地，每一承载杆211的最远端均设置有电极22，并且较佳地，将每一承载杆211的最远端的电极22以及与最远端电极22相邻的电极22设置为第一电极22a，第一电极22a既能用于消融，还能用于标测。
关于通过电极22实现消融功能和标测功能的具体方式还可以参照第一实施例，在此不再赘述。
第五实施例：
本实施例与第一实施例的区别在于：如图9所示，本实施例中，支撑骨架21的各个承载杆211的远端与牵引件4的外周相连接，各个承载杆211的远端的切线与牵引件4的轴线垂直，从而多个承载杆211的远端结合在一起形成具有弧形或圆形结构的形式。
具体地，牵引件4的外周设有多个插孔41，每一插孔41对应地供一承载杆211的远端插接，使得各承载杆211与各插孔41一对一连接。承载杆211与牵引件4相接的端部为承载杆211的最远端，牵引件4的最远端与承载杆211的最远端平滑或者圆滑相接。
该结构中，消融装置的远端同样没有突出的尖端，避免对心房组织造成器械损伤，更好顺应心脏消融区域。
本实施例中关于电极22的设置以及通过电极22实现消融功能和标测功能的具体方式可以参照第一实施例，在此不再赘述。
第六实施例：
本实施例与第五实施例的区别在于：如图10所示，牵引件4包括牵引杆43和设置在牵引杆43远端的连接头44，各个承载杆211连接在连接头44的外周，承载杆211的远端的切线与连接头44的轴线大致垂直，连接头44的远端与多个承载杆211的远端近似地相切或者形成较为圆滑的过渡。
连接头44的远端面与支撑骨架21的远端面大致处于同一切面上，支撑骨架21的外形轮廓能够大致呈球状或笼状，因此，支撑骨架21整体贴靠比较稳定且任意角度都可以消融，可以很好地适应于心房壁、二尖瓣峡部、三尖瓣峡部的打点划线消融，能够达到整体快速高效有质量的消融的目标。
连接头44可以作为消融电极或者标测电极等有标测和消融的性能的电极使用，充分提高连接头44的使用性能，从而系统地增强消融装置的使用性能。在连接头44作为消融电极时，由于连接头44的远端面和多个承载杆211的远端近似相切或者较为圆润的过渡，因此可以使得连接头44和多根承载杆211的远端部分设置的电极22处于同一个消融球面或者消融弧面，从而能够达到整体快速高效有质量的消融的目标。另外当连接头44作为消融电极时，既可以作为射频消融功能来消融，也可以作为脉冲消融来消融。术者可以根据患者不同的情况做出针对性的消融策略加以调整，可以扩大病灶位置的消融范围，从而满足更多的适应症的消融要求。当连接头44作为标测电极时，连接头44可以单独通过导线与连接器(图中未示出)的一个导电端子32形成一对一连接，连接头44可以很好地贴靠心肌表面，有利于提高标测精度。连接头44可以单独作为标测电极，同时，连接头44也可以和承载杆211上的第一电极22a一起组成标测 电极对。
本实施例中，对于电极22在承载杆211上的设置方式，以及电极22实现消融功能和标测功能的具体方式可以参照第一实施例，在此不赘述。
第七实施例：
本实施例与第六实施例的区别在于：如图11所示，本实施例中，支撑骨架21还包括多个支撑杆215，每一支撑杆215用于连接相邻的两个承载杆211。每一支撑杆215的一端连接其中一承载杆211，另一端连接相邻的另一承载杆211。支撑杆215倾斜延伸，其两端在沿外管1的轴向上具有间隔。
通过支撑杆215可以对相邻的承载杆211进行约束，从而可以使得相邻的承载杆211之间保持间距，防止消融装置在工作时发生承载杆211偏移，避免相邻的承载杆211上的电极22相互接触而短路，从而避免产生电弧。
同时，支撑杆215提高了承载杆211在周向上分布的均匀性，使得支撑骨架21整体不易于扭曲变形，提高了消融装置进行消融和标测的精准度及效率。
本实施例中，同一承载杆211的两侧分别设置有一个支撑杆215，分列承载杆211两侧的支撑杆215均朝向远端或均朝向近端延伸至连接相邻的另一承载杆211，即分列同一承载杆211两侧的两个支撑杆215是相互背离地延伸。
本实施例中，分列同一承载杆211两侧的支撑杆215关于承载杆211是不对称的，也即分列在承载杆211的两侧的两个支撑杆215在承载杆211上的连接位置具有轴向间隔。两个支撑杆215的一端连接在同一承载杆211的不同位置处，另一端沿相互背离的方向延伸。这种不对称结构有利于提高支撑骨架21整体球形的稳定贴靠性、球体弧形的可调控性、整个球体结构的稳定性以及球体骨架不容易产生变形。
可以理解，对支撑杆215的位置不做限定，支撑杆215可以设置在承载杆211的中间位置部分，也可以在承载杆211的远端位置部分，还可以设置在承载杆211的近端位置部分。
本实施例中，对于电极22在承载杆211上的设置方式，以及电极22实现消融功能和标测功能的具体方式可以参照第一实施例，在此不赘述。
第八实施例：
本实施例与第七实施例的区别在于：如图12所示，本实施例中，分列在同一承载杆211的两侧的支撑杆215相对于承载杆211呈对称设置。
该结构中，从支撑骨架21的整个外周来看，多个承载杆211中两两承载杆211之间设置的支撑杆215形成大致上连续的V字形或W字形的环状结构。该环状结构使多个支撑杆215之间能够相互支撑、抵靠，进而对各个承载杆211进行轴向和周向上的约束，提高支撑骨架21形状的稳定性，从而有利于提高消融和标测的准确性。
本实施例中，对于电极22在承载杆211上的设置方式，以及电极22实现消融功能和标测功能的具体方式可以参照第一实施例，在此不赘述。
虽已参照几个典型实施方式描述了本发明，但应理解，所用的术语是说明和示例性、而非限制性的术语。由于本发明能够以多种形式具体实施而不脱离发明的精神或实质，所以应理解，上述实施方式不限于任何前述细节，而应在随附权利要求所限定的精神和范围内广泛地解释，因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。

Claims (37)

  1. 一种消融装置，其特征在于，包括：
    外管；
    消融组件，其设于所述外管的远端，包括沿径向可收缩和膨胀的支撑骨架和设置在所述支撑骨架上的多个电极；其中，多个所述电极中具有至少一个能够用于标测的第一电极；
    连接器，其设于所述外管的近端，所述连接器包括多个导电端子，所述连接器通过多个所述导电端子与多个所述电极形成电连接，多个所述导电端子中具有至少一个第一端子，每一所述第一端子与对应的一个所述第一电极形成一对一电连接，以在所述连接器连接至外部标测设备时，所述第一电极通过所述第一端子能够用于标测。
  2. 根据权利要求1所述的消融装置，其特征在于，所述支撑骨架包括绕所述外管的轴线周向排列的多个承载杆，多个所述承载杆的近端与所述外管的远端相连，多个所述承载杆的远端向所述外管的轴线方向收拢；至少部分的所述承载杆上设置有所述电极。
  3. 根据权利要求2所述的消融装置，其特征在于，至少两个所述承载杆上分别设有一个所述第一电极；在所述连接器连接所述外部标测设备时，其中任意两个所述第一电极作为标测电极对以用于标测。
  4. 根据权利要求3所述的消融装置，其特征在于，每一所述承载杆上均设有一个所述第一电极。
  5. 根据权利要求4所述的消融装置，其特征在于，多个所述承载杆上的所述第一电极沿轴向对应，并环绕所述外管的轴线呈周向间隔布置。
  6. 根据权利要求5所述的消融装置，其特征在于，所述第一电极位于所述承载杆上沿径向最远离所述外管的轴线的位置。
  7. 根据权利要求6所述的消融装置，其特征在于，在所述连接器连接所述外部标测设备时，相邻的两个所述承载杆上的所述第一电极作为标测电极对以用于标测。
  8. 根据权利要求2所述的消融装置，其特征在于，其中至少一所述承载杆上沿轴向间隔设有三个以上的所述电极，且该三个以上的所述电极中具有至少两个所述第一电极；在所述连接器连接所述外部标测设备时，其中任意两个所述第一电极作为标测电极对以用于标测。
  9. 根据权利要求8所述的消融装置，其特征在于，其中一所述第一电极位于所述承载杆上最远离所述外管的轴线的位置。
  10. 根据权利要求9所述的消融装置，其特征在于，在所述连接器连接所述外部标测设备时，同一所述承载杆上相邻设置或者非相邻设置的两个所述第一电极作为标测电极对以用于标测。
  11. 根据权利要求8所述的消融装置，其特征在于，至少一所述承载杆上的该三个以上的所述电极全部为所述第一电极。
  12. 根据权利要求8所述的消融装置，其特征在于，多个所述承载杆上各自沿其延伸方向间隔设有三个以上的所述电极；在多个所述承载杆中，所述电极沿轴向一一对应，并环绕所述外管的轴线呈周向间隔布置。
  13. 根据权利要求12所述的消融装置，其特征在于，该三个以上的所述电极中具有两个相邻的所述第一电极，其中一所述第一电极位于所述承载杆上最远离所述外管的轴线的位置；在所述连接器连接所述外部标测设备时，同一所述承载杆上两个相邻的所述第一电极作为标测电极对以用于标测。
  14. 根据权利要求1-13任一项所述的消融装置，其特征在于，多个所述电极中具有仅用于消融的多个第二电极，所述多个导电端子中具有与多个所述第二电极电连接的至少一个第二端子，所述第二端子的数量少于或等于所述第二电极的数量。
  15. 根据权利要求2-13任一项所述的消融装置，其特征在于，所述承载杆具有沿径向最远离所述外 管的轴线的最外端，所述电极布置在所述承载杆的远端和所述最外端之间。
  16. 根据权利要求2-13任一项所述的消融装置，其特征在于，所述消融装置包括牵引件；所述牵引件穿设在所述外管内，所述牵引件的远端连接所述多个承载杆的远端，所述牵引件能够相对于所述外管沿轴向移动以带动所述支撑骨架沿径向收缩或沿径向膨胀。
  17. 根据权利要求16所述的消融装置，其特征在于，所述消融装置还包括参考电极，每一所述参考电极与所述连接器的其中一个所述导电端子形成一对一电连接；所述参考电极位于所述外管或所述牵引件上或位于所述支撑骨架的最远端，所述参考电极与所述第一电极能够组成标测电极对。
  18. 根据权利要求16所述的消融装置，其特征在于，所述承载杆由其近端向其远端呈螺旋状延伸，所述承载杆的远端相对于所述承载杆的近端在沿所述外管的周向上具有周向偏转角度。
  19. 根据权利要求18所述的消融装置，其特征在于，所述承载杆具有位于其近端和其远端之间的一中间位置，所述承载杆在所述中间位置处的螺旋角大于所述承载杆在其近端处或其远端处的螺旋角。
  20. 根据权利要求19所述的消融装置，其特征在于，所述承载杆的螺旋角从所述中间位置处向所述承载杆的近端处或所述承载杆的远端处逐渐减小。
  21. 根据权利要求20所述的消融装置，其特征在于，所述承载杆在垂直于所述外管的轴线的一平面上的投影呈对称形状。
  22. 根据权利要求18所述的消融装置，其特征在于，所述支撑骨架还包括定位框；所述定位框的近端连接多个所述承载杆的远端，所述定位框的远端连接所述牵引件的远端；在所述支撑骨架完全膨胀的状态下，所述定位框的径向尺寸小于多个所述承载杆所围成的框体的径向尺寸。
  23. 根据权利要求22所述的消融装置，其特征在于，所述定位框包括多个主杆和多个分杆；多个所述主杆沿所述牵引件的周向排布，每一所述主杆的远端连接所述牵引件的远端，每一所述主杆的近端连接多个所述分杆的远端；每一所述承载杆的远端连接对应的多个所述分杆的近端，且连接同一所述承载杆的多个所述分杆的远端连接不同的主杆。
  24. 根据权利要求23所述的消融装置，其特征在于，连接同一所述主杆的多个所述分杆之间具有夹角。
  25. 根据权利要求24所述的消融装置，其特征在于，每一所述主杆的近端连接两个所述分杆的远端，且连接同一所述主杆的两个所述分杆沿相互背离的方向延伸，连接同一所述主杆的两个所述分杆的近端连接相邻的两个所述承载杆的远端。
  26. 根据权利要求23所述的消融装置，其特征在于，多个所述分杆首尾相连围合成环绕所述牵引件的波形环状结构，每一所述主杆的近端连接所述波形环状结构的波峰，每一所述承载杆的远端连接所述波形环状结构的波谷。
  27. 根据权利要求23所述的消融装置，其特征在于，所述主杆与所述分杆的相接处朝远离所述牵引件的一侧弯曲，所述承载杆与所述分杆的连接处朝靠近所述牵引件的一侧弯曲。
  28. 根据权利要求16所述的消融装置，其特征在于，所述承载杆的远端形成有反包部，所述反包部由所述承载杆的最远端向靠近所述牵引件的轴线的方向弯折并向近端延伸形成，所述反包部连接所述牵引件的远端，所述承载杆的最远端在往远端的方向上超出所述牵引件的远端。
  29. 根据权利要求27所述的消融装置，其特征在于，所述承载杆的最远端布置有所述第一电极。
  30. 根据权利要求16所述的消融装置，其特征在于，所述承载杆的远端与所述牵引件的外周相连接，所述承载杆的远端的切线与所述牵引件的轴线垂直。
  31. 根据权利要求30所述的消融装置，其特征在于，所述牵引件的外周设有多个插孔，每一所述承载杆的远端对应插接在一所述插孔中。
  32. 根据权利要求31所述的消融装置，其特征在于，所述牵引件包括牵引杆和设置在所述牵引杆远 端的连接头，所述承载杆连接在所述连接头的外周，所述连接头能够用于消融和标测。
  33. 根据权利要求28所述的消融装置，其特征在于，所述支撑骨架还包括多个支撑杆；每一所述支撑杆的一端连接其中一所述承载杆，另一端连接相邻的另一所述承载杆。
  34. 根据权利要求33所述的消融装置，其特征在于，所述支撑杆的两端在沿所述外管的轴向上具有间隔，同一所述承载杆的两侧分别设置有至少一个所述支撑杆，分列所述承载杆两侧的所述支撑杆均朝向远端或均朝向近端延伸至连接相邻的另一所述承载杆。
  35. 根据权利要求34所述的消融装置，其特征在于，分列在同一所述承载杆的两侧的所述支撑杆相对于所述承载杆呈对称设置。
  36. 根据权利要求34所述的消融装置，其特征在于，分列在所述承载杆的两侧的各个所述支撑杆在所述承载杆上的连接位置具有轴向间隔。
  37. 根据权利要求1所述的消融装置，其特征在于，在所述连接器与外部消融能量源连接时，所述第一电极能够通过所述第一端子进行单独控制以放电，进而使得被控制放电的所述第一电极能够向其所在的区域传递所述外部消融能量源输出的消融能量以进行局部消融。
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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022214870A1 (en) 2021-04-07 2022-10-13 Btl Medical Technologies S.R.O. Pulsed field ablation device and method
IL309432A (en) 2021-07-06 2024-02-01 Btl Medical Dev A S Apparatus and method for ablation (burning) by electric pulse field
CN114404035A (zh) * 2022-01-21 2022-04-29 杭州德诺电生理医疗科技有限公司 消融装置
CN115844521B (zh) * 2023-02-15 2023-05-09 四川锦江电子医疗器械科技股份有限公司 具有可变形态的电极导管

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040019349A1 (en) * 2002-07-23 2004-01-29 Fuimaono Kristine B. Ablation catheter having stabilizing array
CN213525440U (zh) * 2020-06-29 2021-06-25 杭州诺茂医疗科技有限公司 消融导管
CN113440243A (zh) * 2020-06-28 2021-09-28 杭州诺茂医疗科技有限公司 消融装置及消融系统
CN113939241A (zh) * 2019-05-07 2022-01-14 Crc Ep公司 带有多个环段的标测和消融导管
CN114404035A (zh) * 2022-01-21 2022-04-29 杭州德诺电生理医疗科技有限公司 消融装置

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6246899B1 (en) * 1997-10-20 2001-06-12 Irvine Biomedical, Inc. Ultrasound locating system having ablation capabilities
CN202426651U (zh) * 2012-01-19 2012-09-12 洪浪 冠状静脉标测导管
JP6592526B2 (ja) * 2015-05-11 2019-10-16 セント・ジュード・メディカル，カーディオロジー・ディヴィジョン，インコーポレイテッド 高密度マッピングおよびアブレーションカテーテル
AU2016259312A1 (en) * 2015-12-09 2017-06-29 Biosense Webster (Israel) Ltd. Dual node multiray electrode catheter
AU2021253769A1 (en) * 2020-04-09 2022-11-10 Neurent Medical Limited Systems and methods for identifying and characterizing tissue and providing targeted treatment thereof
CN215384579U (zh) * 2021-07-12 2022-01-04 心航路医学科技(广州)有限公司 一种网篮形消融导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040019349A1 (en) * 2002-07-23 2004-01-29 Fuimaono Kristine B. Ablation catheter having stabilizing array
CN113939241A (zh) * 2019-05-07 2022-01-14 Crc Ep公司 带有多个环段的标测和消融导管
CN113440243A (zh) * 2020-06-28 2021-09-28 杭州诺茂医疗科技有限公司 消融装置及消融系统
CN213525440U (zh) * 2020-06-29 2021-06-25 杭州诺茂医疗科技有限公司 消融导管
CN114404035A (zh) * 2022-01-21 2022-04-29 杭州德诺电生理医疗科技有限公司 消融装置

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