WO2024022152A1 - 消融系统 - Google Patents

消融系统 Download PDF

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Publication number
WO2024022152A1
WO2024022152A1 PCT/CN2023/107785 CN2023107785W WO2024022152A1 WO 2024022152 A1 WO2024022152 A1 WO 2024022152A1 CN 2023107785 W CN2023107785 W CN 2023107785W WO 2024022152 A1 WO2024022152 A1 WO 2024022152A1
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WO
WIPO (PCT)
Prior art keywords
conductive part
ablation
atrial appendage
left atrial
conductive
Prior art date
Application number
PCT/CN2023/107785
Other languages
English (en)
French (fr)
Inventor
李建民
王坤
尤岩
Original Assignee
杭州德诺电生理医疗科技有限公司
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
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Application filed by 杭州德诺电生理医疗科技有限公司 filed Critical 杭州德诺电生理医疗科技有限公司
Publication of WO2024022152A1 publication Critical patent/WO2024022152A1/zh

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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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613—Irreversible electroporation
    • 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
    • A61B2018/00964—Features of probes

Definitions

  • the present application belongs to the technical field of medical devices, and more specifically, relates to an ablation system.
  • Atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained arrhythmia. As age increases, the incidence of atrial fibrillation continues to increase, reaching 10% in people over 75 years old. During atrial fibrillation, the frequency of atrial activation reaches 300 to 600 beats/min. The heartbeat frequency is often fast and irregular, sometimes reaching 100 to 160 beats/min. Not only is the heartbeat much faster than that of normal people, but it is also absolutely irregular, and the atria are lost. Effective contraction function. Atrial fibrillation generally increases the risk of developing a number of potentially fatal complications, including thromboembolic stroke, dilated cardiomyopathy, and congestive heart failure.
  • Atrial fibrillation symptoms such as heart palpitations, chest pain, difficulty breathing, fatigue, and dizziness can also affect life. quality.
  • people with atrial fibrillation have a five-fold increase in incidence and a two-fold increase in mortality compared with normal people.
  • Tissue ablation is commonly used to treat a variety of cardiac arrhythmias, including atrial fibrillation.
  • an ablation catheter can be used to perform ablation to cause tissue degeneration and necrosis at the lesion, thereby blocking the conduction of abnormal electrical signals and achieving the goal of radical cure for atrial fibrillation.
  • Most of the existing ablation catheters are based on thermal ablation, such as radiofrequency ablation, laser ablation, microwave ablation, hot material ablation, etc.
  • ablation devices based on the principle of thermal ablation ablate tissues by generating heat.
  • the ablation electrode in the ablation device has high requirements for adhesion. If the ablation electrode adheres poorly to the wall, the ablation success rate is low.
  • the purpose of the embodiment of the present application is to provide an ablation system, including a support body and an ablation member, at least part of the ablation member is provided on the support body, the ablation member includes a first conductive part and a second conductive part, The first conductive part and the second conductive part are used to form a loop to transmit pulse ablation energy, and their polarities are opposite. The average current densities of the first conductive part and the second conductive part are not equal.
  • the average current density on the surface of the two conductive parts that form a circuit for transmitting pulse energy is close.
  • a method of increasing the overall ablation energy of the two conductive parts (such as increasing the pulse voltage) is generally used to increase the average current density of one of the conductive parts.
  • the beneficial effect of the ablation system provided by this application is that compared with the prior art, in the ablation system of this application, the average current density of the first conductive part and the second conductive part is not equal, and it can pass through the first conductive part and the second conductive part.
  • pulse ablation energy with different polarities is transmitted to the target tissue to achieve pulse ablation of the target tissue.
  • the ablation system of this application adopts pulse ablation, using pulsed electric fields to cause irreversible electrical breakdown of cell membranes (irreversible electroporation), causing cell apoptosis to achieve non-thermal effect ablation of cells. Therefore, it is not affected by the heat sink effect, and the pulse ablation treatment time is short.
  • the treatment time of applying a set of pulse sequences is less than 1 minute, and the entire ablation time generally does not exceed 5 minutes.
  • different tissues have different response thresholds to pulsed electric fields, it provides the possibility to ablate the myocardium without disturbing other adjacent tissues, thereby avoiding accidental injury to tissues adjacent to the pulmonary veins.
  • pulse ablation does not require heat conduction to ablate deep tissues.
  • the average current densities of the first conductive part and the second conductive part are not equal, that is, the average current densities on the surfaces of at least two different conductive parts constituting the loop are different, so that the first conductive part and the second conductive part Among the two conductive parts, the one with larger expected ablation depth and ablation range will have a larger average current density.
  • the The average current density of one of the two conductive parts constituting the loop is set to be relatively large, and the average circuit density of the other conductive part is set to be relatively small, so that the conductive part with the larger average current density obtains a relatively greater result.
  • Figure 1 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the first embodiment of the present application;
  • Figure 2 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the second embodiment of the present application;
  • Figure 3 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the third embodiment of the present application.
  • Figure 4 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the fourth embodiment of the present application.
  • Figure 5 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the fifth embodiment of the present application.
  • Figure 6A is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the sixth embodiment of the present application.
  • Figure 6B is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided with a coating according to the sixth embodiment of the present application;
  • Figure 7 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the seventh embodiment of the present application.
  • Figure 8 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the eighth embodiment of the present application.
  • Figure 9 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the ninth embodiment of the present application.
  • Figure 10 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the tenth embodiment of the present application.
  • Figure 11 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the eleventh embodiment of the present application.
  • Figure 12 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the twelfth embodiment of the present application.
  • Figure 13 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the thirteenth embodiment of the present application;
  • Figure 14 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the fourteenth embodiment of the present application;
  • Figure 15A is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the fifteenth embodiment of the present application;
  • Figure 15B is a schematic structural diagram of the left atrial appendage occlusion and ablation device in Figure 15A without showing the coating;
  • Figure 15C is a schematic structural diagram of a left atrial appendage occlusion and ablation device based on another modified embodiment of the fifteenth embodiment of the present application;
  • Figure 15D is a schematic structural diagram of the left atrial appendage occlusion and ablation device in Figure 15C without showing the coating;
  • Figure 16 is a schematic diagram of the ablation zone spacing distribution of the ablation member provided in the fifteenth embodiment
  • Figure 17 is a schematic diagram of the partially overlapping distribution of the ablation zone of the ablation member provided in the fifteenth embodiment
  • Figure 18 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the sixteenth embodiment of the present application.
  • Figure 19 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided by the seventeenth embodiment of the present application.
  • Figure 20 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the eighteenth embodiment of the present application.
  • Figure 21 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the nineteenth embodiment of the present application.
  • Figure 22 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided in the twentieth embodiment of the present application.
  • Figure 23A is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided in the twenty-first embodiment of the present application;
  • Figure 23B is a schematic structural diagram of the left atrial appendage occlusion and ablation device in Figure 23A without showing the coating;
  • Figure 24 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-second embodiment of the present application.
  • Figure 25 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided in the twenty-third embodiment of the present application.
  • Figure 26 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-fourth embodiment of the present application.
  • Figure 27 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-fifth embodiment of the present application.
  • Figure 28 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-sixth embodiment of the present application.
  • Figure 29A is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-seventh embodiment of the present application.
  • Figure 29B is a schematic structural diagram of a left atrial appendage occlusion and ablation device based on a modified implementation of the twenty-seventh embodiment of the present application;
  • Figure 29C is a schematic structural diagram of the left atrial appendage occlusion and ablation device in Figure 29B without showing the coating;
  • Figure 30 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-eighth embodiment of the present application.
  • Figure 31 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the twenty-ninth embodiment of the present application.
  • Figure 32 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided in the thirtieth embodiment of the present application.
  • Figure 33 is a schematic structural diagram of the left atrial appendage blocking and ablation device provided in the thirty-first embodiment of the present application.
  • Figure 34 is a schematic structural diagram of the left atrial appendage occlusion and ablation device provided by the thirty-second embodiment of the present application;
  • Figure 35 is a schematic structural diagram of an ablation system provided by the thirty-third embodiment of the present application.
  • Figure 36 is a schematic diagram of the principle structure of the ablation system shown in Figure 35;
  • Figure 37 is a schematic structural diagram of an ablation system provided by the thirty-fourth embodiment of the present application.
  • Figure 38 is a schematic structural diagram of an ablation system provided by the thirty-fifth embodiment of the present application.
  • Figure 39 is a schematic structural diagram of an ablation system provided by the thirty-sixth embodiment of the present application.
  • Figure 40 is a schematic structural diagram of an ablation system provided by the thirty-seventh embodiment of the present application.
  • Figure 41 is a schematic structural diagram of an ablation system provided by the thirty-eighth embodiment of the present application.
  • Figure 42 is a schematic structural diagram of an ablation system provided by the thirty-ninth embodiment of the present application.
  • Figure 43 is a schematic structural diagram of an ablation system provided by the fortieth embodiment of the present application.
  • Figure 44 is a schematic structural diagram of an ablation system provided by the forty-first embodiment of the present application.
  • Figure 45 is a schematic structural diagram of an ablation system provided by the forty-second embodiment of the present application.
  • Figure 46 is a schematic diagram of the principle structure of the ablation system shown in Figure 45;
  • Figure 47 is a schematic structural diagram of an ablation system provided by the forty-third embodiment of the present application.
  • Figure 48 is a schematic structural diagram of the ablation system provided by the forty-fourth embodiment of the present application.
  • Figure 49A is a schematic structural diagram of an ablation system provided by the forty-fifth embodiment of the present application.
  • Figure 49B is a schematic structural diagram of the anchoring portion in Figure 49A without showing the coating
  • Figure 49C is a schematic structural diagram of an ablation system provided based on a modified implementation of the forty-fifth embodiment
  • Figure 49D is a schematic structural diagram of an ablation system provided based on the modified implementation of Figure 49C;
  • Figure 49E is a schematic structural diagram of the anchoring portion in Figure 49D without coating
  • Figure 50 is a schematic structural diagram of an ablation system provided by the forty-sixth embodiment of the present application.
  • Figure 51 is a schematic structural diagram of the ablation system provided by the forty-seventh embodiment of the present application.
  • Figure 52 is a schematic structural diagram of the ablation system provided by the forty-eighth embodiment of the present application.
  • Figure 53 is a schematic structural diagram of the ablation system provided by the forty-ninth embodiment of the present application.
  • Figure 54 is a schematic structural diagram of an ablation system provided by the fiftieth embodiment of the present application.
  • Figure 55 is a schematic structural diagram of an ablation system provided by the fifty-first embodiment of the present application.
  • Figure 56 is a schematic structural diagram of an ablation system provided by the fifty-second embodiment of the present application.
  • Figure 57 is a schematic structural diagram of an ablation system provided by the fifty-third embodiment of the present application.
  • Figure 58 is a schematic structural diagram of the ablation system provided by the fifty-fourth embodiment of the present application.
  • Figure 59 is a schematic structural diagram of an ablation system provided by the fifty-fifth embodiment of the present application.
  • first and second are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Therefore, features defined as “first” and “second” may explicitly or implicitly include one or more of these features.
  • plurality means two or more than two, unless otherwise explicitly and specifically limited.
  • Orifice of the left atrial appendage The point where the left atrium enters the left atrial appendage.
  • Proximal end and distal end In the field of medical device technology, the end of a medical device implanted in the human body or animal body that is closer to the operator is generally called the proximal end, and the end that is farther from the operator is called the distal end. Define the proximal and distal ends of any component of a medical device based on this principle. Without violating the technical principles of the present application, the specific technical solutions in the following embodiments may be mutually applicable.
  • Proximal and distal sides Along the channel for transporting medical devices in the living body, the side of the medical device or its components implanted in the human body or animal body that faces the operator is called the proximal side, and the side away from the operator is called the proximal side. On the far side, as long as the technical principles of the present application are not violated, the specific technical solutions in the following embodiments may be mutually applicable.
  • Axial direction generally refers to the length direction of a medical device when being transported
  • radial direction generally refers to the direction perpendicular to the "axial direction” of the medical device. Based on this principle, the "axial direction” of the medical device is defined. “Axis” and “Radial” of any part.
  • Insulating treatment forming an insulating layer on the surface of a component to insulate that part of the component.
  • the insulation treatment method includes: setting up an insulating coating material at the location that needs to be insulated.
  • the coating material includes but is not limited to parylene coating, PTFE (Poly-tetra-fluoroethylene, polytetrafluoroethylene) coating. , PI (Polyimide, polyimide) coating; or, cover the location where insulation treatment is required.
  • Film materials include but are not limited to FEP (Fluorinated-ethylene-propylene, perfluorinated ethylene propylene copolymer), PU ( polyurethane, polyurethane), ETFE (ethylene-tetra-fluoro-ethylene, ethylene-tetrafluoroethylene copolymer), PFA (Polyfluoroalkoxy, tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer), PTFE, PEEK (poly-ether-ether-ketone, polyether ether ketone), silica gel. Or, wear an insulating sleeve at the location that needs to be insulated.
  • FEP Fluorinated-ethylene-propylene, perfluorinated ethylene propylene copolymer
  • PU polyurethane, polyurethane
  • ETFE ethylene-tetra-fluoro-ethylene, ethylene-tetrafluoroethylene copolymer
  • PFA Polyfluoroalk
  • the materials of the insulating sleeve include but are not limited to FEP, PU, ETFE, PFA, PTFE, PEEK, and silicone.
  • at least one of the above insulation treatment methods can be performed on the part that requires insulation treatment, or a combination of two or more of the same or different insulation treatment methods can be used.
  • the ablation system uses percutaneous puncture to deliver the ablation device to the target tissue through a delivery device, including but not limited to delivering it to a specific location in the heart for pulmonary veins, left atrial appendage, or combined with typical atrial flutter. , ablate triggering lesions that do not originate from the pulmonary veins (such as the superior vena cava, coronary sinus openings, etc.) to achieve the effect of electrical isolation. It can be understood that the ablated tissue area is not limited to the heart, but can also be located in other body tissues, which is not limited here.
  • the ablation system provided by the embodiments of the present application may be a left atrial appendage occlusion ablation system, or other devices used to seal and ablate tissue, or an ablation catheter that does not need to be implanted in the body and is only used to ablate target tissues. , that is, it can be an ablation system only used to ablate tissue.
  • the ablation system provided by the embodiment of the present application includes a support body, a transporter and an ablation component. The distal end of the conveyor is connected to the support body and is used to deliver the support body to the target tissue.
  • the ablation element is at least partially disposed on the support body.
  • the ablation element includes a first conductive part and a second conductive part.
  • the first conductive part and the second conductive part are both disposed on the support body.
  • one of the first conductive part and the second conductive part is provided on the support body.
  • the conductive part that is not provided on the support body may be provided on the conveyor, or relative to the support body and the conveyor. Independently provided, that is, the conductive part not provided on the support body is not provided on the transporter, such as an extracorporeal conductive part provided on the patient's body surface, such as a metal plate provided outside the body.
  • the first conductive part and the second conductive part are both electrically connected to the external pulse ablation source, and the first conductive part and the second conductive part are used to transmit pulse ablation energy with different polarities to the target tissue to achieve tissue ablation.
  • the support body includes a radially shrinkable and expandable skeleton or a balloon.
  • the skeleton can be made by weaving or cutting processes and form multiple meshes.
  • the balloon is filled with media to adjust the radial size.
  • the following description takes the skeleton structure as an example.
  • the support body can be provided with a coating on the surface of the skeleton to achieve functions such as blocking thrombus, insulating, and maintaining the mechanical stability of the support body.
  • the ablation system provided in this embodiment includes a left atrial appendage occlusion ablation device 100 and a delivery device.
  • the left atrial appendage occlusion and ablation device 100 is used to perform occlusion and electrical ablation on the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 100 includes a support body and a first conductive part provided on the support body.
  • the support body can be made by a weaving or cutting process and form a skeleton of multiple meshes.
  • the second conductive part is disposed on the support body of the left atrial appendage occlusion and ablation device 100, or is disposed on the conveyor, or the second conductive part is disposed independently of the support body and the conveyor, that is, the second conductive part is disposed between the support body and the conveyor.
  • the second conductive part is an extracorporeal conductive part used to be attached to the patient's body surface during the ablation process.
  • the first conductive part is electrically connected to the external pulse ablation instrument through the transmitter.
  • the target tissue is the left atrial appendage in myocardial tissue.
  • the support body includes a sealing part 110 and an anchoring part 120 that are connected to each other.
  • the sealing part 110 is used to seal the opening of the left atrial appendage
  • the anchoring part 120 is used to be fixed to the left atrial appendage tissue wall.
  • the sealing part 110 and the anchoring part 120 are both radially telescopic and expandable structures, and any part of the sealing part 110 and the anchoring part 120 can be manufactured using a weaving process or a cutting process.
  • the sealing part 110 is provided on the proximal side of the anchoring part 120.
  • the anchoring part is provided on the circumferential edge of the sealing part.
  • the sealing part 110 includes a first frame 111, the anchoring part includes a second frame 121, the first frame 111 and the second frame 121 are connected to each other; the sealing part 110 is provided with an ablation member for transmitting ablation energy, specifically an ablation member.
  • the first conductive part 150 in .
  • the left atrial appendage occlusion and ablation device 100 in this embodiment has a single disk structure, that is, the sealing part 110 and the anchoring part 120 in the left atrial appendage occlusion and ablation device 100 are located on the same disk surface, and the periphery of the sealing part 110 and the anchoring part 120 The skeleton toward the edge area is used to abut the left atrial appendage tissue.
  • the sealing portion 110 is disposed on the proximal side of the anchoring portion 120.
  • the proximal end surface of the sealing portion 110 is used for release at the left atrial appendage orifice, and the circumferential edge area of the first frame 111 is used to abut against the left atrial appendage orifice and the left atrial appendage lumen.
  • the tissue wall, especially the part with the largest radial dimension in the first frame 111 is used to abut against the tissue wall of the left atrial appendage lumen.
  • the left atrial appendage occlusion and ablation device 100 is provided with at least one layer of coating on the inside or outside of the device 100 to block the outflow of thrombus, that is, the support body includes at least one layer of coating provided on the outer area/or inner surface of the skeleton to block the left atrial appendage occlusion and ablation device 100 .
  • the thrombus inside the atrial appendage flows out into the left atrium.
  • the anchoring part 120 is used to be released into the inner cavity of the left atrial appendage, and the circumferential side wall of the second skeleton 121 in the anchoring part 120 is used to cause damage to the inner wall of the left atrial appendage.
  • the second frame includes a plurality of anchor spurs 129 provided on its surface.
  • the anchor spurs 129 are radially tilted relative to the frame in a circumferential direction, so that after the anchoring portion 120 is released, the anchor spurs 129 can be combined with the second frame.
  • the anchoring ability of the anchoring part 120 is improved.
  • the anchoring portion 120 has a distal opening structure, or the left atrial appendage occlusion and ablation device 100 has a cup-shaped structure.
  • the sealing part 110 is provided with a first conductive part 150 for transmitting ablation energy.
  • a first conductive part 150 for transmitting ablation energy.
  • at least part of the first conductive portion 150 can be used to collect tissue physiological signals.
  • the first conductive part 150 serves as the first conductive part 150. More specifically, the entire first skeleton 111 serves as the first conductive part 150.
  • the first conductive part 150 is used to transmit ablation energy. In some embodiments, the first conductive part 150 can also be used to collect tissue physiological signals, such as cardiac electrophysiological signals, to achieve signal mapping before and after ablation.
  • the tissue at the mouth of the left atrial appendage has a smooth and regular surface relative to the tissue in the inner cavity of the left atrial appendage, which facilitates the contact of the sealing part 110.
  • the entire first skeleton in the sealing part 110 serves as the first conductive part to ablate the tissue at the mouth of the left atrial appendage. It is beneficial to improve the wall-adhering performance of the first conductive part 150 and facilitate the ablation of the left atrial appendage oral tissue.
  • a portion of the first frame 111 serves as the first conductive portion 150 .
  • the first frame 111 includes an edge area and a central area. The central area is closer to the central axis of the sealing portion 110 than the edge area. The central axis passes through the central area. The largest radial dimension of the sealing portion 110 is located in the circumferential direction.
  • the first conductive part 150 is provided in the circumferential edge area of the sealing part 110 so that the first conductive part 150 can be in close contact with or close to the left atrial appendage tissue. Further, in some embodiments, the first conductive part 150 is provided in the area with the largest radial dimension on the first frame 111 .
  • the first conductive part 150 is provided in the edge area of the first frame 111, or further, the first conductive part 150 is provided in the area with the largest radial dimension on the first frame 111.
  • the first conductive part 150 is not provided on the first frame 111.
  • the central area of the skeleton 111 thereby reduces the area where the ablation energy is released, and concentrates the ablation energy at the position of the first conductive part 150 with a smaller discharge area, which is beneficial to increasing the ablation depth.
  • the sealing portion 110 is made of a conductive material, and can be made of a super-elastic metal material with good biocompatibility, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials.
  • the left atrial appendage occlusion and ablation device 100 has an integrated structure.
  • the left atrial appendage occlusion and ablation device 100 in Figure 1 is made of a nickel-titanium alloy tube laser cut. It can be understood that the left atrial appendage occlusion and ablation device 100 can also be made of other metal materials with good biocompatibility, or made of Made by processes other than cutting, such as weaving.
  • the surface of the second frame 121 in the anchoring part 120 is subjected to insulation treatment.
  • the sealing part 110 is provided with a first conductive part 150 for ablating tissue, that is, the left atrial appendage occlusion and ablation device 100 can use the first conductive part 150 to ablate tissue.
  • the left atrial appendage occlusion and ablation device 100 includes a first conductive connector 130 provided on the first frame 111 .
  • the first conductive connector 130 is used to electrically connect the first conductive part 150 to an external ablation energy source.
  • the external ablation signal source may be a pulse ablation instrument, and the pulse ablation instrument is used to output pulse ablation electrical energy for the left atrial appendage blocking ablation device 100 to perform an ablation operation.
  • Pulse ablation is used to use pulsed electric fields to cause irreversible electrical breakdown of cell membranes (irreversible electroporation), causing cell apoptosis to achieve non-thermal effect ablation of cells, so it is not affected by the heat sink effect.
  • 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. And because different tissues have different response thresholds to pulsed electric fields, it provides the possibility to ablate the myocardium without disturbing other adjacent tissues, thus avoiding accidental injury to tissues adjacent to the pulmonary veins. In addition, compared with other energies, pulse ablation does not require heat conduction to ablate deep tissues.
  • the first conductive connector 130 is disposed at the proximal end of the sealing portion 110 and is preferably made of conductive material to transmit electrical energy, such as stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials.
  • the proximal end of the first frame 111 is converged on the first conductive connector 130.
  • the first conductive connector 130 is also used to connect the conveyor.
  • the distal end of the conveyor is mechanically connected to the first conductive connector 130 and realizes the connection with the first conductive connector 130.
  • the first electrically conductive connector 130 is used to maintain an electrical connection between the proximal end of the delivery device and the external ablation energy source.
  • a second conductive part for use with the first conductive part 150 may be provided outside the left atrial appendage occlusion and ablation device 100.
  • the second conductive part is used for transmitting ablation energy.
  • the second conductive part is used for transmitting ablation energy.
  • At least part of the two conductive parts can be used to collect tissue physiological signals.
  • the first conductive part is electrically isolated from the second conductive part, and the first conductive part and the second conductive part may be used to transmit pulse ablation energy with different polarities to the left atrial appendage tissue to achieve tissue ablation.
  • the first conductive part and the second conductive part have different polarities.
  • the conductive part with one polarity is the first conductive part
  • the conductive part with the other polarity is the second conductive part.
  • a conductive part is arranged on the support body.
  • the second conductive part may be disposed on the conveyor, such as a catheter used to connect the first conductive connector 130 in the conveyor, or may be disposed on a movable component (such as an ablation catheter) in the conveyor.
  • the components can move relative to the left atrial appendage occlusion and ablation device 100, the movable component is used to be released from the distal end of the transporter, and the first conductive part 150 and the second conductive part are formed between the left atrial appendage group and the left atrial appendage group.
  • the second conductive portion may be released proximally, lumenally or distally of the left atrial appendage occlusion and ablation device 100 .
  • the second conductive part is disposed independently of the left atrial appendage occlusion and ablation device 100 and the delivery device, and the first conductive part 150 in the left atrial appendage occlusion and ablation device 100 is disposed independently of the left atrial appendage occlusion and ablation device 100 and the delivery device. It is used in conjunction with a second conductive part other than the device.
  • the second conductive part is a second conductive part attached to the patient's body surface during the ablation process.
  • the second conductive part may be connected to the external pulse ablation instrument through a transmitter or other cable.
  • the left atrial appendage occlusion and ablation device 100 is provided with a second conductive part in the anchoring part 120, and the second conductive part can It is part or all of the second frame of the anchoring part 120, and the first conductive part 150 and the second conductive part are insulatedly connected.
  • the first frame 111 serves as the first conductive part 150
  • at least part of the second frame 121 serves as the second conductive part.
  • the first frame 111 and the second frame 121 are insulated from each other.
  • the connection between the first frame 111 and the second frame 121 is made of insulating material, for example, insulating glue is used for bonding, insulating connectors are used for connection, or the third
  • the distal end of one frame 111 and/or the proximal end of the second frame 121 is made of insulating material.
  • the left atrial appendage occlusion and ablation device 100 is also provided with a second conductive connector, and the second conductive connector is used to electrically connect with the second conductive part, and the first conductive part Connector 130 is electrically isolated from the second conductive connector to transmit ablation electrical energy of different polarities.
  • the first conductive connection member 130 and the second conductive connection member are insulatingly connected, for example, an insulating material is used to be disposed between them.
  • a second wire may be used to achieve electrical connection between the second conductive connecting member and the second conductive part.
  • the second conductive part is electrically connected to the transporter through a second wire. After the ablation is completed, The second conductive wire is separated from the conveyor, or the second conductive wire is separated from the second conductive part, or the second conductive wire is cut off. It can be understood that the connection method between the second conductive part and the conveyor can be applied to the connection method between the first conductive part 150 and the conveyor, and will not be described again here.
  • the tissue of the left atrial appendage Compared with the tissue in the inner cavity of the left atrial appendage, the tissue of the left atrial appendage has a smooth surface and a regular shape, which facilitates the sealing part 110 to abut. Part or all of the first skeleton 111 in the sealing part 110 serves as the first conductive part 150, which is close to the left atrial appendage orifice. Ablating the tissue in the left atrial appendage is beneficial to improving the wall-adhesion performance of the first conductive part 150 and facilitates ablation of the tissue in the left atrial appendage mouth.
  • the first frame 111 includes a plurality of sealing rods 112. Each sealing rod 112 extends between the proximal end and the distal end. The proximal ends of the plurality of sealing rods 112 are combined with the first sealing rod 112.
  • a conductive connector 130 it can be understood that the proximal ends of the multiple sealing rods 112 are not limited to being combined with the first conductive connector 130, but can also be combined with other components.
  • a plurality of sealing rods 112 extend around the first conductive connector 130 in different directions, and the distal ends of the plurality of sealing rods 112 are spaced apart from each other, so that the first skeleton 111 forms a hollow structure with a mesh.
  • the second frame 121 extends from the ends of a plurality of spaced sealing rods 112 of the first frame 111 .
  • the second frame 121 includes one anchoring rod 122 and two anchoring rods 123 .
  • the first anchoring rod 122 is connected between the first sealing rod 112 and the second anchoring rod 123.
  • the far end of each sealing rod 112 is connected to two different anchoring rods 122, and the two anchors of the same sealing rod 112 are connected.
  • the extending directions of fixed rods 122 are different.
  • the middle sections of the two adjacent anchoring rods 122 connecting different sealing rods 112 are connected close to each other, and anchors 129 are provided at the mutually connected positions.
  • the distal ends of the two anchoring rods 122 connected to the same sealing rod 112 are connected to each other, and are connected to the proximal ends of the two anchoring rods 123.
  • the distal ends of the two anchoring rods 123 extend to the far end, and the adjacent anchors
  • the two anchoring rods 123 are spaced apart from each other, that is, the distal ends of the two anchoring rods 123 are not connected or brought together, thereby forming a structure in which the distal end of the anchoring part 120 is open, that is, the distal end of the second skeleton 121 and the left atrial appendage are blocked.
  • the distal end of the ablation device 100 has an open structure.
  • the multiple anchoring rods 122 form multiple meshes in the anchoring part 120, which facilitates improving the radial deformation capability of the anchoring part 120 and the friction between the anchoring part 120 and the tissue.
  • the anchor spur 129 extends from the proximal end to the distal end.
  • the fixed end of the anchor spur 129 is connected to the anchor rod 122.
  • the free end of the anchor spur 129 is tilted radially to all sides relative to the anchor rod 122 to facilitate connection with the left atrial appendage. The internal organization is held together.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 200, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 200 includes a sealing portion 210 disposed at the proximal end and a sealing portion 210 disposed at the proximal end.
  • the distal anchoring portion 220, the sealing portion 210 and the anchoring portion 220 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 200 and the left atrial appendage occlusion and ablation device 100 is that the second conductive part 260 is provided on the frame of the left atrial appendage occlusion and ablation device 200, and the second conductive part 260 is used to transmit ablation energy;
  • the conductive part 260 is provided on the anchoring part 220; the first conductive part 250 and the second conductive part 260 form electrical isolation, and the first conductive part 250 and the second conductive part 260 are used to transmit pulses of different polarities to the left atrial appendage. Dissolve energy.
  • At least part of the first conductive part 250 and/or the second conductive part 260 can be used to collect tissue physiological signals.
  • the second conductive part 260 is at least one electrode member additionally provided on the surface of the anchoring part 220 .
  • the second conductive part 260 is made of biophase Made of conductive materials with good capacitance, such as platinum, iridium, gold, silver and other medical metals that can be used for interventional treatments.
  • the number of electrode elements in the second conductive part 260 is one, and specifically the electrode element is a ring electrode.
  • the ring electrode is a strip-shaped or wire-shaped electrode, such as an electrode wire or an electrode sheet, extending circumferentially along the anchoring portion 220 and surrounding the anchoring portion 220 for at least one week.
  • the ring electrode is in a ring shape, such as a circular ring, an elliptical ring, or an irregular ring, so as to form a ring-shaped ablation zone.
  • the ring electrode is arranged in a plane perpendicular to the central axis of the left atrial appendage occlusion and ablation device 200 , that is, each part of the ring electrode is located at the same axial position on the left atrial appendage occlusion and ablation device 200 .
  • the annular electrode is disposed in a plane that is inclined relative to the central axis of the left atrial appendage occlusion and ablation device 200 .
  • the first conductive part 250 is disposed in the circumferential edge region of the proximal part of the support body
  • the second conductive part 260 is disposed in the circumferential edge region of the distal part of the support body
  • the second conductive part 260 is connected to the first conductive part 260 .
  • the conductive portions 250 work together to ablate tissue.
  • the entire surface of the second frame 221 needs to be insulated.
  • the parts of the second frame 221 that are not in contact with the second conductive part 260 are insulated, and the parts that are in contact with the second conductive part 260 are Some parts do not require insulation.
  • the part of the second frame 221 that is in contact with the second conductive part 260 is insulated, and the part that is not in contact with the second conductive part 260 does not need to be insulated, or is selectively insulated.
  • an ablation electric field for ablating the target tissue is generated between the two conductive parts.
  • the ablation zone of each conductive part is an area where the electric field intensity formed around the conductive part is greater than the threshold intensity of the target tissue, and the target tissue located in the ablation zone can be ablated.
  • the area where the electric field strength formed around the first conductive part 250 is greater than the threshold field strength of the target tissue is the first ablation zone
  • the area where the electric field strength formed around the second conductive part 260 is greater than the threshold field strength of the target tissue is the second ablation zone.
  • the left atrial appendage occlusion and ablation device 200 is used to ablate the left atrial appendage in the myocardial tissue.
  • the ablation electric field cannot ablate the left atrial appendage.
  • the auricle has no physiological effect.
  • the pulse breaks down the cell membrane to form nanoscale irreversible electroporation, destroying the homeostasis of the intracellular environment, resulting in necrosis or apoptosis of left atrial appendage cells.
  • tissue ablation needs to be completely transmural, that is, irreversible electroporation occurs on both the inner and outer walls of the tissue.
  • the pulsed ablation energy acts on the cell membrane of the target tissue, and the cells form irreversible electroporation pores, thus destroying the homeostasis of the internal and external environment of the cells, achieving an electrical isolation effect, and thus ensuring that the left atrial appendage and the left atrial appendage located on both sides of the target tissue are Electrophysiological signals cannot be transmitted between atria to achieve the purpose of treating atrial fibrillation.
  • High transmurality requires that the electric field strength covering the inner and outer walls of the left atrial appendage must be greater than the myocardial threshold field strength.
  • the wall thickness of the left atrial appendage is generally 3 mm.
  • the electric field intensity generated by the ablation element at a position 3 mm from its surface is greater than the myocardial threshold field intensity.
  • the intensity of the electric field generated is set to greater than 400V/cm, thereby ensuring that transmural ablation of left atrial appendage tissue in different patients can be achieved.
  • the electric field intensity covering the outer wall of the left atrial appendage is above 400V/cm
  • the electric field intensity formed on the surface of the ablation component is greater than the electric field intensity of the outer wall of the left atrial appendage, and is greater than the myocardial threshold of 400V/cm.
  • the intensity of the electric field acting on myocardial tissue cells is related to the pulse voltage range, the discharge area of the ablation component, and the distance between the conductive parts.
  • the pulse voltage range used by the ablation element is 500V to 4000V.
  • the discharge area of the conductive part 250 is 15mm2 ⁇ 4700mm2, and the discharge area of the second conductive part 260 is 15mm2 ⁇ 4700mm2.
  • the value range of the discharge area refers to the sum of the discharge areas of all electrode members of the conductive part.
  • the distance between the two closest points on the surface of the first conductive part 250 and the second conductive part 260 ranges from 1 mm to 45 mm.
  • the first conductive part 250 and the second conductive part 260 are both arranged on the frame of the left atrial appendage occlusion and ablation device 200.
  • the two conductive parts transmit impulse ablation electrical energy with different pulse polarities.
  • the first conductive part 250 and the second conductive part 260 They are arranged at different positions in the axial direction of the skeleton of the left atrial appendage occlusion and ablation device 200 at intervals, and the voltage range is 500V to 4000V. If the voltage is too low, the intensity of the electric field generated between the two conductive parts is too low, and the ablation zone is too small to ablate through the wall, and the ablation effect will not be achieved.
  • the insulation performance requirements of the left atrial appendage occlusion and ablation device 200 and the delivery device are relatively high, and it is difficult to meet the voltage withstand requirements with existing insulation processes and materials.
  • the voltage is too high, especially when the insulation performance of the left atrial appendage occlusion and ablation device 200 and the delivery device cannot meet the requirements, it is easy to cause electrical coupling between the ablation component and other components, resulting in sparks and tissue eschar. , and even cause harmful consequences to the human body such as cardiac perforation and pericardial effusion.
  • the two conductive parts may be in various forms such as point-like, rod-like, linear or sheet-like. No matter which form is adopted, the key role is the distance between the two conductive parts and the discharge area of each conductive part.
  • the distance between the two conductive parts directly affects the intensity of the electric field formed between the two electrodes.
  • the size of the discharge area of the conductive part can change the current density around the conductive part, further affecting the electric field effect.
  • the current is constant, if the discharge area of the ablation element is too large, the current density will be too small, the electric field intensity formed on the surface of the conductive part will be too low, the depth of the ablation zone will be shallow, and the electric field intensity at the outer wall of the left atrial appendage will be difficult to reach the myocardial threshold intensity. Transmural ablation is formed, and the ablation success rate is low. If the discharge area is too small and the current density is too high, the conductive part is easily electrically coupled with other components, generating sparks. The components in the left atrial appendage blocking ablation device 200 are easily melted or burned due to overheating, and the insulating material is damaged. Damage, and the adhesion of the conductive part to the wall cannot be guaranteed.
  • the pulse voltage is in the range of 500V to 4000V
  • the discharge area of the ablation component is in the range of 15mm2 to 4700mm2
  • the distance between the two conductive parts is in the range of 1mm to 45mm, which is beneficial to the electric field strength formed at the outer wall of the left atrial appendage being greater than the myocardium.
  • the threshold field strength for example, during the ablation process, the electric field intensity generated by the ablation element at a distance of 3 mm from its surface is greater than 400V/cm, which is conducive to the ablation zone covering the outer wall of the left atrial appendage, thereby forming transmural ablation of the left atrial appendage tissue.
  • the above parameters are applicable to various forms of the conductive part, such as formed on at least a part of the skeleton, or various forms of electrodes.
  • the first conductive part 250 and the second conductive part 260 are used to form a loop to transmit pulse ablation energy, and their polarities are opposite.
  • the average current density of the first conductive part 250 and the second conductive part 260 is not equal.
  • the average current density of the first conductive part 250 is greater than the average current density of the second conductive part 260 , or the average current density of the first conductive part 250 is less than the average current density of the second conductive part 260 , thereby facilitating the connection between the first conductive part 250 and
  • the second conductive portion 260 with the larger expected ablation depth and ablation range has a larger average current density.
  • the average current densities of the first conductive part 250 and the second conductive part 260 are not equal, that is, the surface average current densities of at least two different conductive parts constituting the circuit are different.
  • the one with the larger expected ablation depth and ablation range will have a larger average current density. According to the differences in different target tissues, the specific positions of different conductive parts, and the expected ablation depth and ablation range, the two conductive circuits that form the circuit can be combined.
  • the average current density of one conductive part in the part is set to be relatively large, and the average circuit density of the other conductive part is set to be relatively small, so that the conductive part with a larger average current density obtains a relatively larger ablation range, and the deeper ablation range is Ablation depth, thereby improving the ablation effect, achieving complete electrical isolation, and avoiding the formation of a loop.
  • the average surface current density of a pair of conductive parts used to transmit pulse ablation energy is the same, the size of the ablation range and the ablation depth are similar, wall adhesion conditions in different conductive parts Different locations in the target tissue have different depths, which results in some target tissues being able to achieve transmural ablation, while some target tissues are more difficult to ablate transmurally. Therefore, the ablation energy is increased to ensure that all target tissues can achieve transmural ablation. After the ablation strategy, the patient's body is greatly irritated.
  • first conductive part 250 and the second conductive part 260 are spaced apart in the axial direction, and the first conductive part 250 is disposed proximal to the second conductive part 260 . In other embodiments, the first conductive part 250 and the second conductive part 260 may be spaced apart in the circumferential direction.
  • left atrial appendage occlusion and ablation system 200 in addition to the first conductive part 250 and the second conductive part 260, there may also be Other conductive parts may be provided, that is, the specific number of conductive parts in the left atrial appendage occlusion and ablation system 200 is not limited.
  • the average current density on the surface of the second conductive part is greater than the average current density on the surface of the first conductive part.
  • the current density of the distal second conductive part is set to be larger, forming a larger ablation range and a deeper ablation depth, which is especially suitable for ablation of cardiac tissue, such as intracardiac Tissue ablation, such as intracardiac oral ablation (ablation of pulmonary veins, left atrial appendage and other tissues), or intracardiac focal ablation.
  • cardiac tissue such as intracardiac Tissue ablation, such as intracardiac oral ablation (ablation of pulmonary veins, left atrial appendage and other tissues), or intracardiac focal ablation.
  • both the first conductive part 250 and the second conductive part 260 are used to ablate the target tissue, that is, to form an ablation zone in the target tissue.
  • the second conductive part 260 is relative to the first conductive part 250.
  • the adhesion condition is poor.
  • Different conductive parts in the ablation system are used to close to different positions of the target tissue during the ablation process, and the conditions for different conductive parts to adhere to the tissue are different. Some conductive parts have better conditions for adhering to the tissue, such as being able to adhere to the target tissue. It is easier to form a larger ablation range and deeper ablation depth; some conductive parts have poor adhesion conditions. For example, due to the location of the conductive part, the location of the target tissue, and the differences in the structure of different patients, the ablation process The middle conductive part is suspended in the air and is far away from the target tissue, so it cannot ablate the target tissue or the ablation range and depth are small, and the ablation effect is very poor.
  • the expected ablation depth of the conductive part with relatively poor wall adhesion conditions is larger, thereby reducing or avoiding the impact of poor wall adhesion conditions on its ablation depth.
  • the average current density of the conductive part with relatively poor wall adhesion conditions is set to be relatively large, so that it can form a larger ablation range and deeper ablation depth, which is conducive to achieving complete electrical isolation, and the conductive parts with better wall adhesion conditions are
  • the average current density of the two conductive parts is relatively small, and a certain ablation depth can be guaranteed when the wall adhesion conditions are good, which is beneficial to ensuring the ablation depth of the two conductive parts and a better ablation effect.
  • the left atrial appendage occlusion and ablation device 200 is used to release and seal at the mouth of the left atrial appendage, the sealing part 210 is used to release and seal at the mouth of the left atrial appendage, and the anchoring part 220 is connected to the distal side of the sealing part 210 for release. And fixed on the inside of the left atrial appendage mouth, the second conductive part 260 is used to ablate the tissue inside the left atrial appendage mouth.
  • the tissue at the mouth of the left atrial appendage has a smooth surface and regular shape compared to the tissue on the inside of the mouth of the left atrial appendage.
  • the cardiac pectinate muscles that migrate into the sinus cavity of the left atrial appendage cause the complexity of the internal structure of the left atrial appendage.
  • the internal muscle bundles of the left atrial appendage are thick and mostly distributed like feathery palm leaves. This is especially obvious on the upper and lower surfaces of the left atrial appendage, while the remaining structures of the cavity wall between the left atrial appendage muscle bundles are extremely thin.
  • the anchoring part 220 is fixed to at least part of the pectinate muscle surface in contact with its peripheral edge, and the second conductive part 260 is provided on the peripheral edge of the anchoring part 220 for After ablation, the tissue inside the mouth of the left atrial appendage can be released and close to the pectinate muscle, but it is difficult to get close to the entire peripheral pectinate muscle surface and the tissue between the muscle bundles.
  • This is beneficial to improving the ablation depth and ablation range of the second conductive part 260 , and is beneficial to forming transmural ablation of the thick muscle bundles around the second conductive part 260 and the thin tissue between the muscle bundles.
  • the discharge area of the second conductive part 260 is smaller than the discharge area of the first conductive part 250, thereby increasing the average current density on the surface of the second conductive part 260 without changing the overall ablation energy of the two conductive parts.
  • the discharge area of the first conductive part 250 is 15mm2 ⁇ 4700mm2, and the discharge area of the second conductive part 260 is 15mm2 ⁇ 500mm2.
  • the surface area of the conductive part of the first conductive part 250 is relatively large, and the surface area of the conductive part of the second conductive part 260 is relatively small.
  • the first conductive part 250 can be implemented in a variety of ways, such as multiple discrete electrode members, arc electrodes, point electrodes, rod electrodes, There are various electrode forms such as electrodes extending at least one circle around the outer wall of the support, or the first conductive part 250 is a partial metal skeleton of the support body.
  • the support body can be made by a weaving process or a cutting process.
  • the area of the first conductive part 250 can facilitate ablation of the target tissue, and avoid the area of the first conductive part 250 being too small, the current density being too high, and the energy being excessively concentrated here to form an electric spark.
  • the ablation range is too small, the ablation zone is reduced, and it is difficult to form a complete ablation zone when the number of conductive parts is limited; it also avoids that the area of the first conductive part is too large, causing the average current density of the first conductive part 250 If it is too low, the ablation range is too small and the ablation depth is too low.
  • the second conductive part 260 is within the above range to avoid the formation of electric sparks due to the area being too small and the current density being too high, and the energy being excessively concentrated here, resulting in the energy distribution of the first conductive part 250 being too small and being unable to penetrate the wall and ablate the zone. decrease.
  • Using the above range for the second conductive part 260 can significantly improve the ablation depth of the second conductive part and ensure the ablation depth and ablation range of the two conductive parts.
  • the discharge area of the first conductive part 250 is 15mm2 ⁇ 4700mm2
  • the discharge area of the second conductive part 260 is 15mm2 ⁇ 300mm2.
  • the distance between the first conductive part 250 and the second conductive part 260 can be further limited to 3 mm to 22 mm, that is, the shortest distance between the first conductive part 250 and the second conductive part 260 is 3 mm to 22 mm, that is, The distance between the closest points of the first conductive part 250 and the second conductive part 260 is 3 mm to 22 mm.
  • the ablation zones of the two conductive parts partially overlap, that is, the first ablation zone and the second ablation zone partially overlap. At least part of the two ablation zones have overlapping portions, so that the size of the ablation zone formed by superimposing the first ablation zone and the second ablation zone is larger.
  • the ablation energy of the two conductive parts is concentrated together, which can ablate the tissue in a relatively large section, which facilitates transmural ablation in the left atrial appendage tissue with uneven thickness and reduces the risk of invasiveness in the skeleton. Effect of release position deviation on ablation performance.
  • the first conductive part 250 and the second conductive part 260 are spaced apart in the axial direction of the skeleton, and the first ablation zone and the second ablation zone are formed at different positions in the axial direction of the ablation system.
  • the sealing part 210 and the anchoring part 220 may have a position in the circumference that is not close to the tissue.
  • the ablation zone at the left atrial appendage is smaller, and the possibility that the ablation zone corresponding to the conductive part will cover the outer wall of the left atrial appendage tissue will be reduced.
  • Ablation gaps are easily formed in the circumferential direction, that is, the probability that the ablation zone cannot form a complete annular ablation zone in the circumferential direction is greatly increased; when the first ablation zone and the second ablation zone at least partially overlap, the first ablation zone and the second ablation zone Partial overlap forms an ablation zone with a larger coverage area and a longer axial length. That is, the two ablation zones have overlapping parts.
  • the ablation zone with a larger coverage area can be covered by the partial overlap.
  • the outer wall of the left atrial appendage tissue reduces the probability that the ablation zone cannot form a complete annular ablation zone in the circumferential direction, and increases the axial length of the annular transmural ablation zone formed in the left atrial appendage, which facilitates the concentration of ablation energy for transmural ablation and improves ablation success. Rate.
  • the ablation zone becomes convex in the circumferential direction, so that transmural ablation can be performed at the overlapping position of the ablation zones.
  • first conductive part 250 and the second conductive part 260 are spaced apart in the circumferential direction of the frame, or the first conductive part 250 and the second conductive part 260 are spaced apart in any position relationship (such as the second conductive part When the second conductive part is provided on the support body and the second conductive part is provided on the conveyor, or the second conductive part is provided independently of the support body and the conveyor, and the directions of the first conductive part and the second conductive part are parallel to each other or not), If the first ablation zone and the second ablation zone partially overlap, it is convenient to form an ablation zone with a larger coverage area and to form a transmural annular ablation zone.
  • the partially overlapping first ablation zone and the second ablation zone form an ablation zone with a larger coverage area, which can cover the inner and outer walls of the left atrial appendage orifice.
  • the left atrial appendage occlusion ablation device 200 can increase the voltage range and reduce the distance between the two conductive parts. This way, the two ablation zones partially overlap, thereby achieving transmural ablation.
  • the natural state is a state in which the left atrial appendage occlusion and ablation device 200 is not subject to external force, that is, the left atrial appendage occlusion and ablation device 200 is not bound by the relevant components of the delivery device and the restraint effect of the tissue.
  • the proximal end of the second conductive part 260 is disposed distal to the distal end of the first conductive part 250 . That is, the distal end of the first conductive part 250 and the proximal end of the second conductive part 260 are staggered in the axial direction, thereby increasing the distance between the two conductive parts and preventing the two conductive parts from During the ablation process, the conditions for adhering to the target tissue wall are similar. When one of the conductive parts has poor conditions for adhering to the tissue wall (such as hanging in the air), the two conductive parts are set relatively close to each other in the axial direction, resulting in another problem. It may happen that one conductive part has poor adhesion to the tissue wall, thereby improving the adhesion conditions of the two conductive parts to ensure the ablation effect of the ablation element.
  • the distance between the two closest points on the surface of the first conductive part 250 and the second conductive part 260 ranges from 3 mm to 18 mm.
  • the shortest distance between the two conductive parts is 3 mm to 18 mm, it can ensure that the distance between the two conductive parts is large.
  • the adhesion conditions of the two conductive parts are different. One of the conductive parts adheres to the wall. In the case of poor conditions, the impact on the adhesion condition of the other conductive part to the wall is small. At the same time, it is ensured that the distance between the two conductive parts is not too large, ensuring the electric field strength and ablation effect formed by the ablation member.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 300, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 300 includes a sealing portion 310 disposed at the proximal end and a sealing portion 310 disposed at the proximal end.
  • the distal anchoring portion 320, the sealing portion 310 and the anchoring portion 320 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 300 provided in this embodiment and the left atrial appendage occlusion and ablation device 200 provided in the second embodiment is that in this embodiment, the second conductive part 360 is disposed near the second frame 321 Side portion; In the second embodiment, the second conductive portion 360 is provided at the distal portion of the second frame 321 .
  • the entire surface of the second frame 321 needs to be insulated.
  • the parts of the second frame 321 that are not in contact with the second conductive part 360 are insulated, and the parts that are in contact with the second conductive part 360 are insulated. Some parts do not require insulation.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 400, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 400 includes a sealing portion 410 disposed at the proximal end and a sealing portion 410 disposed at the proximal end.
  • the distal anchoring portion 420, the sealing portion 410 and the anchoring portion 420 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 400 provided in this embodiment and the left atrial appendage occlusion and ablation device 100 provided in the first embodiment is that the first conductive part 450 provided in the left atrial appendage occlusion and ablation device 400 includes spaced There are a plurality of electrode members on the surface of the sealing part 410, and each electrode member is a point-shaped electrode. Each point electrode is arranged on a different sealing rod. In other embodiments, the number of point electrodes on each sealing rod can be set as needed. For example, at least one sealing rod is not provided with a point. shaped electrodes, or multiple point-shaped electrodes on one seal and one rod.
  • Each point electrode is in the shape of points, such as granular electrodes surrounded by straight lines or curves.
  • the cross-section of each point-shaped electrode is circular, elliptical, annular, rectangular, trapezoidal, other polygonal or irregular.
  • multiple point electrodes in the first conductive part 450 are used to transmit the same ablation electric energy.
  • adjacent point electrodes are used to transmit ablation electric energy with different parameters, such as electrodes. sexually different ablation energy.
  • the ablation electric energy used to be transmitted by each point electrode is set according to needs, for example, multiple point electrodes are grouped, and the point electrodes in the same group are used to transmit ablation electric energy with the same parameters.
  • the first conductive part 450 is insulated from the first frame 411.
  • the surface of the first frame 411 is insulated, or the plurality of electrode members in the first conductive part 450 contacts the first frame 411.
  • One side surface is insulated.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 500, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 500 includes a sealing portion 510 disposed at the proximal end and a sealing portion 510 disposed at the proximal end.
  • the distal anchoring portion 520, the sealing portion 510 and the anchoring portion 520 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 500 provided in this embodiment and the left atrial appendage occlusion and ablation device 400 provided in the fourth embodiment is that the plurality of conductive parts 550 provided in the first conductive part 550 of the left atrial appendage occlusion and ablation device 500 Each electrode piece is a rod-shaped electrode.
  • each rod-shaped electrode is in the shape of a rod, or a long strip, and the two ends of the rod-shaped electrode extend between the proximal end and the distal end. In some embodiments, both ends of the rod-shaped electrode extend in the circumferential direction of the left atrial appendage occlusion and ablation device 500 . In some embodiments, the extension direction of the rod-shaped electrode is arranged obliquely relative to the axis of the left atrial appendage occlusion and ablation device 500 .
  • multiple rod-shaped electrodes in the first conductive part 550 are used to transmit the same ablation electric energy.
  • adjacent rod-shaped electrodes are used to transmit ablation electric energy with different parameters, such as electrodes. sexually different ablation energy.
  • the ablation electric energy used to be transmitted by each rod-shaped electrode is set according to needs, for example, multiple rod-shaped electrodes are grouped, and the rod-shaped electrodes in the same group are used to transmit the same ablation electric energy.
  • the first conductive part 550 and the first frame 511 are insulated.
  • the surface of the first frame 511 is insulated. processing, or the plurality of electrode pieces in the first conductive part 550 contact the surface of one side of the first frame 511 to insulate.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 600, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 600 includes a sealing portion 610 disposed at the proximal end and a sealing portion 610 disposed at the proximal end.
  • the distal anchoring portion 620, the sealing portion 610 and the anchoring portion 620 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 600 provided in this embodiment and the left atrial appendage occlusion and ablation device 500 provided in the fifth embodiment is that the plurality of conductive parts 650 provided in the first conductive part 650 of the left atrial appendage occlusion and ablation device 600 Each electrode piece is an arc electrode.
  • each arc electrode is in the shape of an arc and extends circumferentially along the left atrial appendage occlusion and ablation device 600.
  • the arc length occupied by the arc electrode is less than 360 degrees, and multiple arc electrodes are spaced apart from each other on the first frame. 611 on the circumferential surface.
  • multiple arc electrodes form a ring shape to facilitate the formation of a ring-shaped ablation zone.
  • the number of arc electrodes can be set as needed.
  • the circumferential angles occupied by different arc electrodes in the circumferential direction of the left atrial appendage occlusion and ablation device 600 do not overlap. In some embodiments, the circumferential angles occupied by different arc electrodes in the circumferential direction of the left atrial appendage occlusion and ablation device 600 at least partially overlap.
  • different arc electrodes are located at the same axial position of the left atrial appendage occlusion and ablation device 600 .
  • adjacent arc electrodes are located at different axial positions.
  • the plurality of arc electrodes in the first conductive part 650 are used to transmit the same ablation electric energy.
  • adjacent arc electrodes are used to transmit ablation electric energy with different parameters, such as electrodes. sexually different ablation energy.
  • the ablation electric energy used to be transmitted by each arc electrode is set according to needs, for example, multiple arc electrodes are grouped, and rod-shaped electrodes in the same group are used to transmit the same ablation electric energy.
  • the first conductive part 650 is insulated from the first frame 611.
  • the surface of the first frame 611 is insulated, or the plurality of electrode members in the first conductive part 650 contacts the first frame 611.
  • One side surface is insulated.
  • FIG. 6B is a schematic structural diagram of a coating 690 provided on the surface of the support body in the left atrial appendage occlusion and ablation device 600 shown in FIG. 6A.
  • the support body includes a coating 690 disposed on the outer surface of the skeleton, thereby preventing thrombus in the left atrial appendage from flowing into the left atrium through the mesh of the support body.
  • the sealing portion 610 disposed on the proximal side of the support body is used to seal the left atrial appendage.
  • the coating 690 at least covers the sealing portion 610. It can be understood that the distal end of the coating 690 can extend to the surface of the anchoring portion 620.
  • a coating 690 is provided on the surface of the support body to prevent the support body from directly contacting the tissue, thereby increasing the contact area between the support body and the tissue, thereby reducing the stimulation of the tissue by the support body's skeleton and metal materials, which is beneficial to reducing postoperative complications. incidence rate.
  • the coating 690 is also used to maintain the stability of the skeleton structure, avoid excessive deformation of the skeleton, and improve the stability of the anchoring after the support is implanted.
  • the distal end of the coating 690 does not extend to the position of the anchor spine, and the anchor spine can smoothly penetrate into the left atrial appendage wall.
  • the coating 690 covers the anchor spine, and the free end of the anchor spine The covering film can be pierced and exposed on the outer surface of the covering film 690, thereby facilitating anchoring of the support body.
  • a coating 690 is provided on at least one of the outer surface and the inner surface of the support body.
  • the coating 690 is disposed between the first conductive part 650 and the support body.
  • the first conductive part 650 and the support body are both made of conductive metal materials.
  • the coating 690 is also an insulating film, used to achieve insulation between the first conductive part 650 and the support body, and to avoid short circuit between the first conductive part 650 and the support body during the process of the first conductive part 650 releasing the ablation energy. , that is, the ablation energy released by the first conductive part 650 is transmitted to the support body.
  • At least one other insulation method can be used between the first conductive part 650 and the support body, such as plating an insulating coating on the surface of the frame, and the support body
  • the surface of the skeleton is covered with an insulating sleeve, the film is thickened, and at least part of the support body is made of insulating materials.
  • the insulation between the first conductive part 650 and the support may be achieved by other means than providing a coating as mentioned in this application.
  • the coating 690 provided in this embodiment can be applied to other embodiments to achieve at least one of the functions of blocking flow, insulating, maintaining structural stability, and reducing tissue irritation. , will not be described in detail here.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 700, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 700 includes a sealing portion 710 disposed at the proximal end and a sealing portion 710 disposed at the proximal end.
  • the distal anchoring portion 720, the sealing portion 710 and the anchoring portion 720 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 700 provided in this embodiment and the left atrial appendage occlusion and ablation device 600 provided in the sixth embodiment is that the first conductive part 750 of the left atrial appendage occlusion and ablation device 700 includes an electrode member.
  • the number is one, and the electrode form is a ring electrode. Please refer to the foregoing embodiments for the specific description of the ring electrode.
  • a second conductive part that cooperates with the first conductive part 750 may be provided in the left atrial appendage occlusion and ablation device 700 , or the second conductive part may be provided on the conveyor, or the second conductive part may be combined with the left atrial appendage occlusion and ablation device 700 Setting up independently of the conveyor is allowed, specifically Please refer to the first embodiment.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 800, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 800 includes a sealing portion 810 disposed at the proximal end and a sealing portion 810 disposed at the proximal end.
  • the distal anchoring portion 820, the sealing portion 810 and the anchoring portion 820 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 800 provided in this embodiment and the left atrial appendage occlusion and ablation device 700 provided in the seventh embodiment is that the distal end of the anchoring portion 820 of the left atrial appendage occlusion and ablation device 800 has a closed structure.
  • the second conductive part 860 is disposed on the frame of the left atrial appendage occlusion and ablation device 800, specifically disposed on the anchoring part 820.
  • the second conductive part 860 is an electrode member disposed on the surface of the anchoring part 820, and the electrode member is in the form of a circle. Ring electrode.
  • the distal end of the anchoring part 820 is closed, that is, the distal ends of the two anchor rods 823 are combined together to close the distal end of the anchoring part 820.
  • the distal end of the anchoring portion 820 is also provided with a connector for tightening the ends of the two anchoring rods 823 .
  • the specific position where the second conductive part 860 is disposed on the anchoring part 820 can be set as needed.
  • the electric field formed between the first conductive part 850 and the second conductive part 860 is used to ablate the left atrial appendage oral tissue.
  • This embodiment can use the flow blocking and insulation methods in the sixth embodiment.
  • a coating is used to block the flow, and to achieve insulation between the first conductive part 850 and the sealing part 810, and between the second conductive part 860 and the anchor. The insulation between the fixed parts 820 and other functions.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 900, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 900 includes a sealing portion 910 disposed at the proximal end and a sealing portion 910 disposed at the proximal end.
  • the distal anchoring portion 920, the sealing portion 910 and the anchoring portion 920 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 900 provided in this embodiment and the left atrial appendage occlusion and ablation device 800 provided in the eighth embodiment is that the first conductive part 950 and the first conductive part 950 provided on the frame of the left atrial appendage occlusion and ablation device 900
  • the two conductive parts 960 are in the form of dot electrodes. Please refer to the aforementioned embodiments for specific descriptions of the dot electrodes.
  • the second conductive part 960 is disposed close to the proximal end of the support body relative to the second conductive part 860 .
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1000, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1000 includes a sealing portion 1010 disposed at the proximal end and a sealing portion 1010 disposed at the proximal end.
  • the distal anchoring portion 1020, the sealing portion 1010 and the anchoring portion 1020 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1000 provided in this embodiment and the left atrial appendage occlusion and ablation device 800 provided in the eighth embodiment is that the first conductive part 1050 and the first conductive part 1050 provided in the left atrial appendage occlusion and ablation device 1000 are The two conductive parts 1060 are both disposed on the sealing part 1010 .
  • the first conductive part 1050 and the second conductive part 1060 are disposed at different axial positions, and the first conductive part 1050 is disposed on the far side of the second conductive part 1060.
  • the first conductive part 1050 and the second conductive part 1060 are both in the form of annular electrodes. Please refer to the aforementioned embodiments for specific descriptions of the annular electrodes.
  • the first conductive part 1050 is disposed in the edge area of the sealing part 1010, preferably, the first conductive part 1050 is disposed at the position with the largest radial dimension of the sealing part 1010.
  • the second conductive part 1060 can be disposed as needed. The proximal or distal side of the first conductive portion 1050 .
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1100, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1100 includes a sealing portion 1110 disposed at the proximal end and a sealing portion 1110 disposed at the proximal end.
  • the distal anchoring portion 1120, the sealing portion 1110 and the anchoring portion 1120 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1100 provided in this embodiment and the left atrial appendage occlusion and ablation device 1000 provided in the tenth embodiment is that the first conductive part 1150 provided on the frame of the left atrial appendage occlusion and ablation device 1100 and the The second conductive parts 1160 are all in the form of dot-shaped electrodes. Please refer to the foregoing embodiments for specific descriptions of the dot-shaped electrodes.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1200, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1200 includes a sealing portion 1210 disposed at the proximal end and a sealing portion 1210 disposed at the proximal end.
  • the distal anchoring portion 1220, the sealing portion 1210 and the anchoring portion 1220 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1200 provided in this embodiment and the left atrial appendage occlusion and ablation device 700 provided in the seventh embodiment is that the sealing part 1210 and the anchoring part 1220 in the left atrial appendage occlusion and ablation device 1200 are The structure is different from the seventh embodiment.
  • the left atrial appendage occlusion and ablation device 1200 is made using a knitting process.
  • the sealing portion 1210 is a portion of the left atrial appendage blocking ablation device 1200
  • the proximal part, the anchoring part 1220 is the distal part of the left atrial appendage occlusion and ablation device 1200.
  • the anchoring part 1220 includes a main body 1222 and a reinforcing ring 1223 that can be disposed at the distal end of the main body 1222.
  • the reinforcing ring 1223 is along the circumference of the main body. To set.
  • the reinforcing ring 1223 is fixed on the outer peripheral surface of the main body 1222, and the portion of the reinforcing ring 1223 close to the main body 1222 is connected to the main body 1222.
  • the portion of the reinforcing ring 1223 that is radially away from the main body 1222 protrudes in a radial direction away from the axis of the left atrial appendage blocking and ablation device 1200 , that is, the reinforcing ring 1223 is protruding from the periphery of the distal end of the main body 1222 .
  • the reinforcing ring 1223 is used to be released inside the left atrial appendage, contact and push against the left atrial appendage tissue, and improve the anchoring performance of the left atrial appendage blocking and ablation device 1200.
  • the reinforcing ring 1223 is a plurality of annular support rings connected to each other in the circumferential direction, and the plurality of annular support rings are arranged in a circle in the circumferential direction.
  • each annular support ring forms a complete ring shape.
  • each annular support ring is a curved structure and does not form a complete ring shape. The ends of adjacent annular support rings The connection is strengthened by circle 1223.
  • the sealing portion 1210 and the main body 1222 can be made of integral weaving.
  • the left atrial appendage blocking ablation device 1200 can be made of integral weaving.
  • the first conductive part 1250 is an electrode member disposed on the surface of the sealing part 1210.
  • the specific electrode form is a ring electrode.
  • the description of the ring electrode is as described in the previous embodiment.
  • the second conductive part 1260 is provided on the left atrial appendage occlusion and ablation device 1200.
  • the second conductive part 1260 is at least part of the second frame 1221.
  • the second conductive portion 1260 is at least part of the skeleton in the reinforcing ring 123 .
  • the first conductive part 1250 interacts with the second conductive part 1260 to facilitate forming an annular ablation zone at the mouth of the left atrial appendage.
  • the second conductive part 1260 please refer to the seventh and first embodiments.
  • the reinforcing ring 1223 is provided on the sealing part 1210 and protrudes in a circumferential circle of the sealing part 1210 for sealing the mouth of the left atrial appendage.
  • the first conductive part 1250 may be at least part of the skeleton in the reinforcing ring 1223, so as to facilitate the formation of an annular ablation zone at the mouth of the left atrial appendage.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1300, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1300 includes a sealing portion 1310 disposed at the proximal end and a sealing portion 1310 disposed at the proximal end.
  • the distal anchoring portion 1320, the sealing portion 1310 and the anchoring portion 1320 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1300 provided in this embodiment and the left atrial appendage occlusion and ablation device 1200 provided in the twelfth embodiment is that the second conductive part 1360 is an electrode member provided on the surface of the anchoring part 1320. More specifically, the electrode member is in the form of a ring electrode. For specific descriptions of the ring electrode, please refer to the foregoing embodiments.
  • the second conductive part 1360 is provided at the free end of the reinforcing ring 1323 .
  • the second conductive part 1360 is disposed at the position with the largest radial dimension of the reinforcing ring, so that the second conductive part 1360 contacts the tissue.
  • the middle portions of the plurality of annular support rings of the reinforcing ring 1323 are connected to form a channel.
  • the second conductive part 1360 is disposed in the channel formed by the reinforcing ring 1323 .
  • the left atrial appendage occlusion and ablation device 1300 includes a receiving portion 1330.
  • the accommodating part 1330 is arranged adjacent to the axis of the support body relative to the first conductive part 1350 and/or the second conductive part 1360.
  • the accommodating part 1330 is adjacent to the axis of the support body relative to the first conductive part 1350 and the second conductive part 1360.
  • the axis is arranged such that an accommodating space for accommodating left atrial appendage tissue is formed on the outside of the circumferential outer wall of the accommodating portion 1330 .
  • the shortest connection between any point on the first conductive part 1350 and any point on the second conductive part 1360 is a characteristic electric field line E.
  • the characteristic electric field line E is linear, starting from one of the first conductive part 1350 and the second conductive part 1360 , and ending at the other of the first conductive part 1350 and the second conductive part 1360 .
  • the electric field intensity distributed near the characteristic electric field line E is denser and larger than the electric field lines at other locations in the electric field. The electric field intensity at this location is more likely to be greater than the target tissue threshold field intensity. Therefore, the characteristic electric field line E passes through The tissue is easily ablated and the ablation effect is better.
  • the first conductive part 1350 and the second conductive part 1360 are provided on opposite sides of the accommodation space.
  • at least one characteristic electric field line E passes through the area outside the support body, that is, passes through the frame away from the
  • the area on one side of the axis is specifically the accommodation space formed outside the accommodation portion 1330 passing through the frame. This facilitates the characteristic electric field lines E to pass through the tissue located in the receiving space.
  • the main body 1322 between the first conductive part 1350 and the second conductive part 1360 is used to abut the radial dimension of the left atrial appendage tissue wall part from the proximal end to the distal end (from the sealing part to the anchor). (direction of the fixed portion) gradually decreases, and the second conductive portion 1360 is disposed at the position with the largest radial size of the reinforcing ring 1323, and the radial size of the second conductive portion 1360 is greater than the radial size of the first conductive portion 1350, or the second conductive portion 1360 is The radial size of the conductive part 1360 is similar to the radial size of the first conductive part 1350 .
  • the portion of the skeleton of the left atrial appendage blocking ablation device 1300 between the first conductive part 1350 and the second conductive part 1360 is the accommodating part 1330, and the outside of the outer wall of the accommodating part 1330 forms an accommodating space for accommodating left atrial appendage tissue.
  • the left atrial appendage blocking and ablation device 1300 is implanted into the left atrial appendage, and at least part of the outer wall of the receiving portion 1330 is used to abut against the left atrial appendage tissue.
  • the left atrial appendage occlusion and ablation device 1300 is made of braiding.
  • the receiving portion 1330 between the first conductive part 1350 and the second conductive part 1360 is arranged around the circumference of the left atrial appendage occlusion and ablation device 1300.
  • the first conductive part 1350 and the second conductive part 1360 are arranged circumferentially.
  • the two conductive parts 1360 are spaced apart in the axial direction, thereby facilitating the accommodation of a circle of tissue around the left atrial appendage into the accommodating part 1330.
  • the first conductive part 1350 and the second conductive part 1360 ablate the tissue in the accommodating part 1330.
  • the atrial appendage forms a continuous annular ablation zone.
  • the formation of the accommodating part 1330 is not limited to the skeleton structure of the left atrial appendage occlusion and ablation device provided in various embodiments of the present application. It may also be formed by having a direction between the carrier of the first conductive part and the second conductive part. Other structures of the left atrial appendage blocking ablation device are recessed in the axial direction, so that the carrier between the first conductive part and the second conductive part forms the above-mentioned accommodation space, that is, the accommodation part for accommodating the target tissue, which can be provided on the support body and the delivery device, or formed between the support body and the conveyor.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1400, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1400 includes a sealing portion 1410 disposed at the proximal end and a sealing portion 1410 disposed at the proximal end.
  • the distal anchoring portion 1420, the sealing portion 1410 and the anchoring portion 1420 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1400 provided in this embodiment and the left atrial appendage occlusion and ablation device 100 provided in the first embodiment is that the left atrial appendage occlusion and ablation device 1400 has a double-disc structure, and the sealing part 1410 is in the form of a disc. shape, the anchoring part 1420 is disk-shaped, and the sealing part 1410 and the anchoring part 1420 are insulated and connected through the connector 1491. At least part of the connecting member 1491 can be made of insulating material to achieve an insulating connection between the sealing portion 1410 and the anchoring portion 1420 .
  • the first skeleton 1411 in the sealing part 1410 is made by a weaving process. From the perspective of FIG. 14 , the distal end surface of the sealing part 1410 is tapered. It can be understood that the proximal end surface of the sealing part 1410 is flat. Shaped or tapered or other shapes.
  • the second frame 1421 in the anchoring part 1420 is obtained by laser cutting the pipe.
  • the second frame 1421 includes one anchoring rod 1422, two anchoring rods 1423, three anchoring rods 1424, and four anchoring rods 1425 that are connected in sequence.
  • the proximal end of the anchor rod 1422 is connected to the connector 1491, the anchor rod 1422 extends between the proximal end and the distal end, and the end of the anchor rod 1422 away from the connector 1491 is connected to the ends of the two anchor rods 1423.
  • one end of each two-anchor rod 1423 is connected to a corresponding one-anchor rod 1422, and the other ends of two adjacent two-anchor rods 1423 are connected together and connected to a corresponding three-anchor rod 1424.
  • the two anchor rods 1423 are connected end to end to form a zigzag structure.
  • the two anchoring rods 1423 are used to form the distal surface of the anchoring portion 1420, and the three anchoring rods 1424 extend between the proximal end and the distal end, are arranged on the periphery of the first anchoring rod 1422, and are used to abut against the inner wall of the left atrial appendage.
  • the proximal end of the anchoring three rods 1424 is connected to the anchoring four rods 1425.
  • One end of the anchoring four rods 1425 is connected to the anchoring three rods 1424.
  • the other end of the anchoring four rods 1425 is a free end, and the free end extends in the direction of the axis. and extend distally.
  • the first conductive part 1450 is provided in the sealing part 1410.
  • the first conductive part 1450 is at least part of the first frame 1411 in the sealing part 1410, such as the entire first frame 1411 or part of the first frame 1411.
  • the first conductive part 1450 is the circumferential edge area of the sealing part 1410 , and is at least disposed at the position with the largest radial dimension in the circumferential edge area of the sealing part 1410 .
  • the first conductive part 1450 is at least disposed on the sealing part 1410 .
  • the circumferential edge area of the portion 1410 faces the anchoring portion 1420, which is used to abut the mouth of the left atrial appendage.
  • the first conductive portion 1450 is disposed in a region of the circumferential edge region of the sealing portion 1410 facing the anchoring portion 1420, and at least a portion of the sealing portion 1410 facing away from the anchoring portion 1420 (at least a portion of the proximal end surface). area).
  • the anchoring part 1420 may use at least part of the second skeleton 1421 as the second conductive part 1460, and the pulsed ablation electric field formed between the first conductive part 1450 and the second conductive part 1460 is used to ablate tissue.
  • the electric field lines are directed from the first conductive part 1450 to the second conductive part 1460, or from the second conductive part 1460 to the first conductive part 1450.
  • the electric field lines there is a distance from the first conductive part 1450 Or the closer the second conductive part 1460 is, the denser the electric field lines are, the greater the intensity of the ablation electric field, and the easier it is to form a through-wall ablation zone.
  • the tissue at the mouth of the left atrial appendage is close to the first conductive part 1450, and the electric field lines are directed to the second conductive part 1460 provided on the anchoring part 1420, or from the second conductive part 1460 to the first conductive part 1450, therefore, most of the Some electric field lines will pass through the tissue at the mouth of the left atrial appendage.
  • the electric field lines at the mouth of the left atrial appendage are dense and the electric field intensity is high. It is easy to form a transmural ablation zone. An electric field with a field strength greater than the myocardial damage threshold passes through the left atrial appendage. The ablation success rate is higher for the oral tissue of the atrial appendage.
  • the shortest connection between any point on the first conductive part 1450 and any point on the second conductive part 1460 is a characteristic electric field line E between the first conductive part 1450 and the second conductive part 1460.
  • the electric field intensity in the area near the characteristic electric field line E is higher than that of other positions in the electric field, and is an area where the electric field energy is relatively concentrated.
  • FIG. 14 is a view of the skeleton in its natural state of expansion without external force, the radial size of the sealing portion 1410 is larger than the mouth of the left atrial appendage, so that the radial size of the surface of the sealing portion 1410 facing the anchoring portion 1420 is larger.
  • the edge area of the left atrial appendage is close to or facing the left atrium.
  • the left atrial appendage oral tissue is sandwiched between the sealing part 1410 and the anchoring part 1420.
  • the frame of the left atrial appendage occlusion and ablation device 1400 includes a receiving portion 1430 disposed between the first conductive portion 1450 and the second conductive portion 1460.
  • the receiving portion 1430 is specifically the first frame and the second conductive portion 1460.
  • the outer side of the outer wall of the accommodating portion 1430 forms an accommodating space for accommodating left atrial appendage tissue.
  • the left atrial appendage blocking and ablation device 1400 is implanted into the left atrial appendage, and at least part of the outer wall of the receiving portion 1430 is used to abut against the left atrial appendage tissue.
  • At least one part of the second conductive part 1460 is closer to the axis of the support body relative to the first conductive part 1450, so that the distal part (closer to the second conductive part 1360) of at least one characteristic electric field line E passing through the accommodation space part) is tilted in the direction close to the axis of the support body.
  • the conductive parts are all arranged on the periphery of the support body, which can reduce the difficulty of the characteristic electric field lines E passing through the tissue in the accommodation space and facilitate the passage of the characteristic electric field lines E passing through the accommodation space. More tissue to be ablated ensures ablation effect.
  • the radial size of the sealing portion 1410 is larger than the radial size of the anchoring portion 1420 , and the first conductive portion 1450 is disposed at a position with the largest radial size of the sealing portion 1410 . Therefore, the radial size of the first conductive portion 1450 The radial size is larger than the second conductive part 1460, so that more of the distal part of the characteristic electric field line E of the first conductive part 1450 is tilted toward the axis direction of the left atrial appendage occlusion and ablation device 1400, so that more of the characteristic electric field line E passes through the first conductive part.
  • the characteristic electric field lines of 1450 pass through the storage space and pass through the deep tissue of the left atrial appendage orifice, so that within a certain thickness range of the left atrial appendage orifice tissue, the electric field intensity formed is greater than the electric field threshold of the myocardium, so that at the left atrial appendage orifice, Transmural ablation occurs.
  • the radial size difference between the first conductive part 1450 and the second conductive part 1460 is between 3-15 mm.
  • the first conductive part 1450 and the second conductive part 1460 are used to be close to the target tissue.
  • the first conductive part can be ensured.
  • the distal side of at least part of the characteristic electric field lines between 1450 and the second conductive part 1460 is inclined toward the axial direction. The first conductive part 1450 and the second conductive part 1460 facilitate the penetration of the characteristic electric field lines during the process of effecting the opening-shaped tissue.
  • the first characteristic point is the point where the radial dimension of the first conductive part 1450 is the largest
  • the second characteristic point is the point where the radial dimension of the second conductive part 1460 is the largest
  • the characteristic plane is the point passing through the support. axis and the plane of the first feature point.
  • the angle between the projection of the shortest characteristic electric field line between the selected first characteristic point and at least one second characteristic point on the characteristic plane and the axis x of the support body is 0-70°.
  • the first characteristic point is a point where the radial dimension of the periphery of the first conductive part 1450 is the largest.
  • the first characteristic point may be any point among multiple points where the radial dimension of the periphery of the first conductive part 1450 is the largest.
  • Select The first characteristic point is a certain point where the radial dimension of the periphery of the first conductive part is the largest.
  • the selected first characteristic point is an annular line. It can be any point in the circular line.
  • the first feature point is located in the feature plane.
  • the second characteristic point is a point where the radial dimension of the periphery of the second conductive part 1460 is the largest.
  • the second characteristic point may be any point among multiple points where the radial dimension of the periphery of the second conductive part 1460 is the largest, In an embodiment where the maximum radial dimension of the periphery of the second conductive portion is in the shape of an annular line, the second characteristic point may be any point in the annular line.
  • the second feature point may be located within the feature plane or outside the feature plane.
  • the number of second characteristic points is at least one.
  • a characteristic electric field line can be obtained between the selected first characteristic point and each second characteristic point.
  • a characteristic electric field line can be obtained between the selected first characteristic point and a plurality of second characteristic points. Multiple characteristic electric field lines corresponding to the two characteristic points are obtained.
  • these characteristic electric field lines there is a characteristic electric field line with the shortest length passing through the selected first characteristic point.
  • this shortest characteristic electric field line passing through the selected first characteristic point is as shown in Figure 14 Characteristic electric field lines E.
  • the starting point of the characteristic electric field line E shown in Figure 14 is the second characteristic point, and the end point is the selected first characteristic point.
  • the shortest characteristic electric field E passing through the selected first characteristic point is the characteristic electric field line farthest from the axis x of the support body in the radial direction. That is, these characteristic electric field lines E are formed on the periphery of the left atrial appendage occlusion and ablation device 1400, relative to other Characteristic electric field lines are more likely to pass through the accommodation space outside the support body, representing the ability of the two conductive parts to radiate electric fields to the outside of the support body.
  • the electric field lines around it are relatively densely distributed and the ablation energy is relatively dense. More concentrated, it can be considered that the target tissue area corresponding to the characteristic electric field line with the shortest length passing through the first characteristic point has a better ablation effect and plays a major ablation role.
  • the shortest characteristic electric field line E passing through the selected first characteristic point is projected on the characteristic plane and has a certain tilt angle s with the axis x of the support body.
  • the characteristic electric field line E is tilted relative to the axis x, which facilitates the characteristic electric field line E to pass through more tissue to be ablated, which is beneficial to ensuring the success rate of ablation.
  • the feature plane passes through the axis x and the first feature point and the second feature point. In other embodiments, the second feature point may not be in the feature plane. Characteristic electric field lines need to be projected onto characteristic planes.
  • This inclination angle s represents the degree of shrinkage of the second conductive part 1460 relative to the radial dimension of the first conductive part 1450 when the distance between the first conductive part 1450 and the second conductive part 1460 is small.
  • the angle s is 0°-70°, which controls the angle from being too large, ensuring that the distance between the two conductive parts is not too large, and ensuring the intensity of the ablation electric field.
  • the first conductive part 1450 and the second conductive part The ablation effect of left atrial appendage tissue near 1460 is better, especially the tissue in contact with the first conductive part 1450 and the second conductive part.
  • the characteristic electric field lines pass through the surface of the left atrial appendage tissue or pass deep into the left atrial appendage tissue, a larger ablation thickness will be ensured and the ablation will be transmural. Since the thickness of the tissue at the mouth of the left atrial appendage is relatively uniform and the shape is regular, it is easy to ablate there and the difficulty of transmural penetration is low.
  • an electrode member is additionally provided on the second frame 1421 as the second conductive part 1460, or a second conductive part is provided outside the left atrial appendage occlusion and ablation device 1400, such as on the left atrial appendage occlusion and ablation device 1400.
  • the transporter of the atrial appendage occlusion and ablation device 1400 may be provided independently from the left atrial appendage occlusion and ablation device 1400 and the transporter.
  • the first conductive part 1450 is provided on the proximal part of the frame, and the second conductive part 1460 is provided on the distal side of the first conductive part 1450 .
  • the radial dimensions of the two conductive parts at the position of the skeleton can be set to be different or the same.
  • the radial size of the first conductive part 1450 is larger than the radial size of the second conductive part 1460 .
  • the first conductive part 1450 is provided in the circumferential edge area with the largest radial size on the first frame 1411 , such as a circular ring electrode is provided in the circumferential edge area with the largest radial size on the proximal side of the first frame 1411 , since the radial size of the first conductive part 1450 is set to be larger than the radial size of the second conductive part 1460, it is convenient for the characteristic electric field line E to pass through the oral tissue.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 1500, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1500 includes a sealing portion 1510 disposed at the proximal end. And an anchoring part 1520 is provided at the distal end, and the sealing part 1510 and the anchoring part 1520 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1500 provided in this embodiment and the left atrial appendage occlusion and ablation device 1400 provided in the fourteenth embodiment is that the second conductive part 1560 is provided in the left atrial appendage occlusion and ablation device 1500.
  • the conductive part 1560 is an electrode member provided on the surface of the anchoring part 1520.
  • the anchoring part 1520 includes a second frame 1521 and a covering film 1590 provided on the outer surface of the second frame 1521.
  • the anchoring part 1520 is provided with a covering film 1590 on its surface.
  • the second conductive part 1560 is provided on the covering film 1590 facing away from the second frame 1521. on one side of the surface.
  • the coating 1590 is used to achieve insulation between the anchoring portion 1520 and the second conductive portion 1560 . It can be understood that other insulation methods provided by other embodiments may be used between the second frame 1521 and the second conductive part 1560. For example, at least one of the second frame 1521 and the second conductive part 1560 is provided with an insulating coating or a sleeve. Insulating sleeves, etc. In some embodiments, at least two identical or different insulation methods are used between the anchoring part 1520 and the second conductive part 1560. For example, a base of the coating 1590 is provided between the second frame 1521 and the second conductive part 1560. On the surface of the second frame 1521 of the anchoring part 1520, an insulating coating or an insulating sleeve is provided on the surface of the second frame 1521 of the anchoring part 1520. On the surface of the second frame 1521 of the anchoring part 1520, an insulating coating or an insulating sleeve is provided. It can be understood that the coating 1590
  • the second conductive part 1560 may be provided as a wave electrode.
  • the wavy electrode extends in the circumferential direction and the axial direction to form a preset electrode pattern.
  • the wavy electrode extends in the circumferential direction of the left atrial appendage occlusion and ablation device 1500, it also alternates in the axial direction. Extend toward the proximal end or distal end, thereby extending in the circumferential direction along a wavy trajectory on the side wall of the anchoring portion 1520, thereby expanding the occupied space of the second conductive portion 1560 in the axial direction, increasing the ablation range, and It is convenient to load and release the left atrial appendage occlusion and ablation device 1500.
  • the first conductive part 1550 and the second conductive part 1560 meet the parameters provided in the previous embodiment.
  • the distance between the first conductive part 1550 and the second conductive part 1560 is 3 mm from their respective surfaces.
  • the electric field intensity generated at the position is greater than 400V/cm.
  • the ablation system is used to ablate cardiac tissue other than the left atrial appendage.
  • the thickness of the pulmonary vein is generally 2 mm, ensuring that during the ablation process, the electric field intensity generated by it at a position 2 mm away from the surface of the ablation component is greater than the myocardial threshold.
  • the field strength is, for example, greater than 400V/cm, thereby facilitating transmural ablation.
  • the pulse voltage range used by the ablation element (first conductive part 1550, second conductive part 1560) is 500V-4000V, and the discharge area of the first conductive part 1550 The range is 15mm2 ⁇ 4700mm2, and the discharge area of the second conductive part 1560 is 15mm2 ⁇ 4700mm2.
  • the discharge area of the second conductive part 1560 can refer to the 15 mm2 to 500 mm2 provided in the previous embodiment.
  • the value range of the discharge area refers to the sum of all discharge areas (electrode parts or skeleton) of the conductive part.
  • the distance between the two closest points on the surface of the first conductive part 1550 and the second conductive part 1560 ranges from 1 mm to 45 mm.
  • the distance between the first conductive part 1550 and the second conductive part 1560 may be further limited to 3 mm to 22 mm. Within this range, it is possible to facilitate the partial overlap of the ablation zones of the two conductive parts.
  • the distance between the two closest points on the surface of the two conductive parts ranges from 3mm to 18mm.
  • the second conductive part 1560 is a wavy electrode with crests and troughs.
  • the crest of the second conductive part 1560 is the apex of the second conductive part 1560 away from the sealing part 1510 .
  • the trough of the second conductive part 1560 is The second conductive portion 1560 is adjacent to the vertex of the sealing portion 1510 .
  • the crests and troughs of the second conductive part 1560 are arranged corresponding to the three anchoring rods 1524 of the anchoring part 1520.
  • the crests and troughs of the second conductive part 1560 can be fixedly arranged on the covering film 1590, or pass through the covering film 1590. , fixed to the anchoring three rods 1524, anchoring the three rods 1524 may be provided with connecting parts (such as through holes) for fixedly connecting the anchoring three rods 1524 .
  • the anchor thorns 1529 pass through the covering film 1590 and are exposed outside the covering film 1590 .
  • the anchor spurs 1529 are provided on the three anchoring rods 1524. Specifically, one anchor spur 1529 is provided on each of the three anchoring rods 1524.
  • the anchor spine 1529 is disposed on the proximal side of the second conductive part 1560. The radial size of the three anchoring rods 1524 at this position is larger, which is beneficial to ensuring the anchoring performance of the anchoring part 1520.
  • the radial dimensions of the locations where the anchor thorns 1529 are provided on the three anchoring rods 1524 are consistent with the second conductive portion 1560 , or the radial dimensions of the locations where the anchor thorns 1529 are provided on the three anchoring rods 1524 are The size is smaller than the radial size of the location where the second conductive portion 1560 is disposed on the three anchor rods 1524 .
  • the difference between the left atrial appendage occlusion and ablation device 1500C and the left atrial appendage occlusion and ablation device 1500 is mainly that the second conductive portion 1560C and the anchoring third
  • the relative position of the rod 1524C is different, and the relative position of the second conductive part 1560C and the anchor thorn 1529C is different.
  • the wave peaks and wave troughs of the second conductive part 1560C are staggered with the three anchoring rods 1524C, that is, the wave peak of the second conductive part 1560C is disposed between two adjacent three anchoring rods 1524C.
  • the trough of the second conductive part 1560C is also disposed between two adjacent three anchoring rods 1524C.
  • the second conductive part 1560C may be fixed to the covering film 1590C through its crest, trough, or part between the crest and the trough, or may be fixed to the three anchoring rods 1524C through the covering film 1590C.
  • the second conductive part 1560C is fixed to the coating 1590C at the peak and trough positions, thereby improving the insulation performance between the second conductive part 1560C and the anchoring part 1520C.
  • the second conductive part 1560C is disposed proximal to the anchor spine 1529C, and when an ablation electric field is formed between the first conductive part 1550C and the second conductive part 1560C, the anchor The electric field intensity at the position of the stab 1529C is small, which prevents the anchor stab 1529C from discharging into the tissue under the action of the ablation electric field, thereby improving the safety of the left atrial appendage blocking ablation device 1500C.
  • FIG. 16 is a schematic diagram of the electric field distributed at intervals in the ablation area of the ablation member provided by the fifteenth embodiment.
  • FIG. 17 is a schematic diagram of the electric field distributed partially overlapping in the ablation area of the ablation member provided by the fifteenth embodiment.
  • the area where the electric field intensity formed around the first conductive part 1550 is greater than the myocardial threshold intensity is the first ablation zone 1551
  • the area where the electric field intensity formed around the second conductive part 1560 is greater than the myocardial threshold intensity is the second ablation zone 1561 .
  • Figures 16 and 17 are both schematic diagrams of the distribution of the ablation zone when the corresponding electric field intensity is greater than or equal to 400V/cm under the condition that the pulse frequency range is 500Hz to 3MHz.
  • the ablation element in Figures 16 and 17 adopts the ablation element in the fifteenth embodiment corresponding to Figure 15A.
  • the ablation element includes a first conductive part 1550 and a second conductive part 1560.
  • the first conductive part 1550 is at least one part of the sealing part 1510.
  • Part of the skeleton, the second conductive part 1560 is a wavy electrode member provided on the anchoring part 1520. It can be seen from Figure 16 that the ablation zones between the two conductive parts do not intersect and overlap, but each form an equivalent curved surface.
  • the left atrial appendage occlusion and ablation device corresponding to Figure 16 blocks the mouth of the left atrial appendage for ablation, the ablation zones formed by the two conductive parts do not overlap.
  • the electric field intensity in the area between the two ablation zones is too low, which will cause this Complete electrical isolation is not possible.
  • the size of the first ablation zone 1551 is smaller than the size of the ablation zone formed after partial overlap of the two ablation zones shown in Figure 17 (the area defined by the outer outline of the dotted line in Figure 17), and the left atrial appendage is blocked and ablated.
  • the ablation zone formed by the sealing part and the anchoring part may not penetrate the wall due to the release angle and position of the sealing part or the anchoring part.
  • the sealing part may be deflected at a certain angle relative to the mouth, that is, the sealing part and the mouth of the left atrial appendage may not fit tightly together, and the first ablation zone 1551 may cover the tissue of the mouth of the left atrial appendage (inner wall). and the outer wall), it does not completely cover the outer wall of the mouth of the left atrial appendage, making it difficult to achieve transmural ablation at the mouth, and thus there is no good ablation effect.
  • the angle at which the anchoring part is released inside the left atrial appendage is too skewed, causing part of the second conductive part 1560 to be suspended and unable to fully adhere to the wall, resulting in poor ablation effect.
  • the ablation member is set up in such a way that the ablation zone partially overlaps as shown in Figure 17.
  • the axial size of the ablation zone is larger than the axial size of any single ablation zone. This makes it easier to concentrate the energy of the two ablation zones on one part. ablation to improve the ablation success rate of the area to be ablated.
  • the ablation zone partially overlaps and has a proximal part and a distal part in the axial direction. Even if the proximal part has poor adhesion, its outer edge cannot cover the outer wall of the left atrial appendage, and the distal part may cover the left atrial appendage. outer wall, thereby reducing the impact on the ablation effect due to the adhesion condition after the sealing part is released, and improving the success rate of ablation.
  • the first conductive part 1550 is provided on the sealing part 1510, and the ablation zone formed by partially overlapping the first ablation zone and the second ablation zone is distributed at the position of the left atrial appendage mouth and the inner wall of the left atrial appendage close to the mouth, so that Ablation is performed near the mouth of the left atrial appendage.
  • the left atrial appendage oral tissue has a smooth surface and regular shape.
  • the first conductive part 1550 is easier to adhere to the wall and has a relatively uniform thickness.
  • the second conductive part 1560 has a higher average current density than the first conductive part 1550. Larger, the ablation depth is larger, so both the first conductive part 1550 and the second conductive part 1560 can achieve better ablation effects near the mouth, and the ablation zone facilitates continuous transmural ablation near the mouth.
  • the wall thickness of the left atrial appendage is generally 3 mm, the distance between the boundary of the two overlapping ablation zones and the surface of the conductive part is large and exceeds the wall thickness of the left atrial appendage, so transmural ablation can be achieved.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 1600, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1600 includes a sealing portion 1610 disposed at the proximal end and a sealing portion 1610 disposed at the proximal end.
  • the distal anchoring portion 1620, the sealing portion 1610 and the anchoring portion 1620 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1600 provided in this embodiment and the left atrial appendage occlusion and ablation device 1500 provided in the fifteenth embodiment is that the first conductive part 1650 is an electrode member provided on the surface of the sealing part 1610.
  • the component is in the form of a ring electrode. Please refer to the aforementioned embodiments for the specific description of the ring electrode.
  • the sealing part 1610 may be provided with at least one coating, and the coating may be disposed on the outer surface or the inner cavity of the sealing part 1610. The coating may be disposed between the first conductive part 1650 and the first frame 1611.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 1700, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1700 includes a sealing portion 1710 disposed at the proximal end and a sealing portion 1710 disposed at the proximal end.
  • the distal anchoring portion 1720, the sealing portion 1710 and the anchoring portion 1720 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1700 provided in this embodiment and the left atrial appendage occlusion and ablation device 1400 provided in the fourteenth embodiment is that the first conductive part 1750 is provided on the surface of the first frame 1711 in the sealing part 1710 electrode parts.
  • the specific form of the electrode member is a plurality of dot-shaped electrodes arranged at intervals. Please refer to the aforementioned embodiments for description of the specific dot-shaped electrodes.
  • the second conductive part may be disposed on the second frame 1721 of the anchoring part 1720, or may not be disposed on the second frame 1721.
  • the second conductive part may be disposed on components other than the second frame 1721.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 1800, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1800 includes a sealing portion 1810 disposed at the proximal end and a sealing portion 1810 disposed at the proximal end.
  • the distal anchoring portion 1820, the sealing portion 1810 and the anchoring portion 1820 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1800 provided in this embodiment and the left atrial appendage occlusion and ablation device 1700 provided in the seventeenth embodiment is that the second conductive part 1860 is provided in the left atrial appendage occlusion and ablation device 1800, specifically:
  • the second skeleton 1821 and the second conductive part 1860 provided on the anchoring part 1820 are a plurality of spaced dot-shaped electrodes located on the surface of the anchoring part 1820.
  • dot-shaped electrodes please refer to the aforementioned embodiments.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 1900, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 1900 includes a sealing portion 1910 disposed at the proximal end and a sealing portion 1910 disposed at the proximal end.
  • the distal anchoring portion 1920, the sealing portion 1910 and the anchoring portion 1920 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 1900 provided in this embodiment and the left atrial appendage occlusion and ablation device 1800 provided in the eighteenth embodiment is that the second conductive part 1960 provided on the surface of the anchoring part 1920 is a wave electrode.
  • the structural form of the wavy electrode refers to the above-mentioned embodiment.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 2000, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2000 includes a sealing portion 2010 disposed at the proximal end and a sealing portion 2010 disposed at the proximal end.
  • the distal anchoring portion 2020, the sealing portion 2010 and the anchoring portion 2020 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2000 provided in this embodiment and the left atrial appendage occlusion and ablation device 1600 provided in the sixteenth embodiment is that the second conductive part 2060 is in the second frame 2021 of the anchoring part 2020 At least partially.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2100, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2100 includes a sealing portion 2110 disposed at the proximal end. And an anchoring part 2120 is provided at the distal end, and the sealing part 2110 and the anchoring part 2120 are connected to each other.
  • Figure 23B in this embodiment is a cross-sectional view of the left atrial appendage occlusion and ablation device 2100 along the axis direction.
  • the main difference between the left atrial appendage occlusion and ablation device 2100 provided in this embodiment and the left atrial appendage occlusion and ablation device 1500C provided in the fifteenth embodiment lies in the specific structures of the sealing part 2110 and the anchoring part 2120.
  • the cross section of the sealing part 2110 along the axis is trapezoidal, and the first frame 2111 includes a distal end facing toward the anchoring part 2120 and a distal end facing away from the anchoring part 2120 .
  • the proximal disk surface and the distal disk surface are roughly flat, and the waist is connected between the proximal disk surface and the distal disk surface, and the waist is cone-shaped.
  • the first conductive part 2150 is at least part of the first frame 2111.
  • the first conductive part 2150 is at least disposed in the edge area with a larger radial dimension of the sealing part 2110, such as the waist 2113.
  • it is disposed in
  • the sealing portion 2110 is the portion with the largest radial dimension in the circumferential direction.
  • the first conductive portion 2150 can also be disposed on the waist 2113 and the proximal disk surface (the part in the dotted frame in the figure). In some embodiments, the first conductive portion 2150 is disposed on the waist 2113, at least part of the proximal disk surface and at least part of the distal disk surface.
  • the part of the surface of the first frame 2111 that is not used as the first conductive part 2150 is insulated.
  • the insulation treatment method can be provided with a film, an insulating sleeve, an insulating coating, or made of insulating materials. at least one of the ways.
  • at least part of the distal surface of the sealing part 2110 is insulated to avoid mutual short circuit between the first conductive part 2150 and the anchoring part 2120 and to improve the insulation between the first conductive part 2150 and the second conductive part 2160 performance.
  • the connector 2130 at the proximal end of the sealing portion 2110 can be used to mechanically connect with the conveyor and achieve electrical connection, so that the first conductive portion 2150 is electrically connected to an external pulse signal source through the connector 2130.
  • the second conductive part 2160 is provided on the anchoring part 2120, and is specifically a wave electrode.
  • a coating 2190 is provided between the second frame 2121 and the second conductive part 2160.
  • the surface of the second frame 2121 may be plated with an insulating coating, or an insulating sleeve may be placed to achieve insulation.
  • at least two identical or different insulation methods are used for insulation between the second frame 2121 and the second conductive part 2160 .
  • a connector 2191 is connected between the sealing part 2110 and the anchoring part 2120.
  • the connector 2191 is at least partially made of insulating material to achieve insulation between the first conductive part 2150 and the second conductive part 2160. connect.
  • the connecting piece 2191 is at least partially made of conductive material and is used for electrical connection between the second conductive part 2160 and the conveyor.
  • the main difference between the anchoring part 2120 and the anchoring part 1520 is that the ends of two adjacent four-anchoring rods 2125 in the anchoring part 2120 that are far away from the three-anchoring rods 2124 are connected together to improve the stability of the anchoring part 2120.
  • the mechanical properties prevent the four anchor rods 2125 from being hooked to each other during the radial deformation process of the left atrial appendage occlusion and ablation device 2100, thereby improving the reliability of the left atrial appendage occlusion and ablation device 2100.
  • the mapping catheter can collect electrical signals at the target tissue. Physiological signals also have the function of releasing ablation energy to target tissues.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2200, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2200 includes a sealing portion 2210 disposed at the proximal end and a sealing portion 2210 disposed at the proximal end.
  • the distal anchoring portion 2220, the sealing portion 2210 and the anchoring portion 2220 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2200 provided in this embodiment and the left atrial appendage occlusion and ablation device 2100 provided in the twenty-first embodiment is that the first conductive part 2250 is provided in the sealing part 2110 with the largest radial size.
  • the electrode piece is in the form of a circular electrode.
  • the second conductive part 2260 is an electrode member disposed on the surface of the anchoring part 2220.
  • the specific form of the electrode member is a plurality of dot-shaped electrodes arranged at intervals. In this embodiment, two point electrodes are provided at intervals on each of the three anchoring rods 2224. In other embodiments, the number of point electrodes provided on each of the three anchoring rods 2224 can be set as needed. Some of the surfaces of the anchored three rods 2224 may not be provided with point electrodes. It can be understood that the left atrial appendage occlusion and ablation device 2200 can be provided with a coating as needed.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2300, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2300 includes a sealing portion 2310 disposed at the proximal end and a sealing portion 2310 disposed at the proximal end.
  • the distal anchoring portion 2320, the sealing portion 2310 and the anchoring portion 2320 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2300 provided in this embodiment and the left atrial appendage occlusion and ablation device 2100 provided in the twenty-first embodiment is that the specific structures of the sealing part 2310 and the anchoring part 2320 are different from those in the twenty-first embodiment. The implementation is different.
  • the sealing part 2310 and the anchoring part 2320 are both made by a weaving process.
  • the first frame 2311 in the sealing part 2310 has a double-layer disk structure, including a distal disk facing toward the anchoring part 2320 and a proximal disk facing away from the anchoring part 2320.
  • the proximal disk surface is approximately flat, the distal disk surface is partially spherical, and there is a gentle transition between the proximal disk surface and the distal disk surface.
  • the first conductive portion 2350 is at least part of the first frame 2311 and is disposed in an edge area with a larger radial dimension in the sealing portion 2310 .
  • the second frame 2321 in the anchoring part 2320 has a double-layer disk structure and is generally cylindrical.
  • the distal radial size of the side wall of the second frame 2321 is smaller than the proximal radial size.
  • the second conductive part 2360 is an electrode member provided on the anchoring part 2320, and the electrode member is in the form of a wave electrode.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2400, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2400 includes a sealing portion 2410 disposed at the proximal end and a sealing portion 2410 disposed at the proximal end.
  • the distal anchoring portion 2420, the sealing portion 2410 and the anchoring portion 2420 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2400 provided in this embodiment and the left atrial appendage occlusion and ablation device 2300 provided in the twenty-third embodiment is that the first conductive part 2450 is a first frame 2411 provided in the sealing part 2410
  • the electrode component on the surface is a specific electrode in the form of a ring electrode. Please refer to the above embodiment for description of the specific ring electrode.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2500, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2500 includes a sealing portion 2510 disposed at the proximal end and a sealing portion 2510 disposed at the proximal end.
  • the distal anchoring portion 2520, the sealing portion 2510 and the anchoring portion 2520 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2500 provided in this embodiment and the left atrial appendage occlusion and ablation device 2300 provided in the twenty-third embodiment is that the structure of the anchoring part 2520 and the structure of the second conductive part 2560 are different from those of the left atrial appendage occlusion and ablation device 2300 provided in the twenty-third embodiment. Twenty-three implementations are different.
  • the anchoring portion 2520 is manufactured by a cutting process.
  • the anchoring part 2520 has a double-layer disc structure, with the proximal end and the distal end closed.
  • the second frame 2521 includes one anchoring rod 2522, two anchoring rods 2523 and three anchoring rods 2524 connected in sequence from the distal end to the proximal end.
  • One anchoring rod 2522, two anchoring rods 2523 and three anchoring rods 2524 all extend between the proximal end and the distal end.
  • the proximal end of each anchoring rod 2522 is connected to two different anchoring two rods 2523.
  • the two anchoring rods 2523 of the same anchoring rod 2522 extend in different directions.
  • the adjacent anchoring rods 2522 connecting different anchoring rods 2522 The middle sections of the two anchor rods 2523 are connected close to each other.
  • the proximal ends of the two anchoring rods 2523 connected to the same anchoring rod 2522 are connected to each other, and the distal ends of the anchoring three rods 2524 are connected.
  • the proximal ends of multiple anchoring rods 2524 are combined together to form an anchor.
  • the fixed portion 120 has a closed structure at both ends.
  • the multiple anchoring rods 2523 form multiple meshes in the anchoring part 2520, which facilitates improving the radial deformation capability of the anchoring part 2520 and the friction between the anchoring part 2520 and the tissue.
  • the second conductive part 2560 is an electrode member disposed on the surface of the second frame 2521 in the anchoring part 2520.
  • the specific electrode is in the form of a ring electrode. Please refer to the above embodiment for description of the specific ring electrode.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2600, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2600 includes a sealing portion 2610 disposed at the proximal end and a sealing portion 2610 disposed at the proximal end.
  • the distal anchoring portion 2620, the sealing portion 2610 and the anchoring portion 2620 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2600 provided in this embodiment and the left atrial appendage occlusion and ablation device 2500 provided in the twenty-fifth embodiment is that the structure of the second conductive part 2660 is different from that in the twenty-fifth embodiment.
  • the second conductive part 2660 is an electrode piece disposed on the surface of the second frame 2621 in the anchoring part 2620.
  • the specific electrodes are in the form of a plurality of point electrodes spaced apart from each other on the surface of the second frame 2621. Specifically, Please refer to the above embodiment for description of the electrode. Twenty-seventh embodiment
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2700, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2700 includes a sealing portion 2710 disposed at the proximal end and a sealing portion 2710 disposed at the proximal end.
  • the distal anchoring portion 2720, the sealing portion 2710 and the anchoring portion 2720 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2700 provided in this embodiment and the left atrial appendage occlusion and ablation device 1500 provided in the fifteenth embodiment lies in the structure of the sealing part 2710 and the structure of the first conductive part 2750.
  • the implementation is different.
  • the first frame 2711 in the sealing part 2710 includes a plurality of sealing rods, and both ends of each sealing rod are disposed at the central axis of the sealing part 2710. Projected on a plane perpendicular to the central axis, that is, looking from the distal end to the proximal end, or from the proximal end to the distal end, each sealing rod forms a roughly annular support ring.
  • the The ring is fan-shaped.
  • the annular shape may be a circular annular shape, an elliptical annular shape, a partial annular shape, or other irregular annular shapes, etc.
  • Multiple support rings surrounded by multiple sealing rods are arranged in the circumferential direction to form the first frame 2711.
  • adjacent support rings overlap each other in the circumferential direction and are projected on a plane perpendicular to the central axis, that is, when viewed from the distal end to the proximal end, or from the proximal end to the distal end.
  • the central angles occupied by adjacent support rings overlap. In other embodiments, the central angles occupied by adjacent support rings do not overlap. In some embodiments, adjacent support rings are spaced apart from each other by central angles.
  • each sealing rod are in different axial positions, that is, the two ends of each sealing rod are staggered in the axial direction. In other embodiments, both ends of each sealing rod are at the same axial position.
  • the first conductive part 2750 is all or part of the first frame 2711 in the sealing part 2710. Specifically, the first conductive part 2750 is the part with a larger radial size in the first frame 2711, including the first part with the largest radial size. Skeleton 2711, in this embodiment, the part between the two dotted-line rings in Figure 29A is the periphery of the sealing part 2710, and the first conductive part 2750 is disposed between the two dotted-line rings in Figure 29A. In some embodiments, the first conductive portion 2750 is disposed at a position with the largest radial dimension in the first frame 2711 , that is, a circle of frame surrounding the circumferential edge of the first frame 2711 .
  • the second conductive part 2760 is a wave electrode provided on the surface of the anchoring part 2720.
  • the wave troughs and crests of the second conductive part 2760 are arranged corresponding to the three anchoring rods of the anchoring part 2720.
  • the second conductive part 2760 and the second skeleton of the anchoring part 2720 there is an insulation design between the second conductive part 2760 and the second skeleton of the anchoring part 2720.
  • a coating is provided between the second conductive part 2760 and the second skeleton of the anchoring part 2720.
  • the surface of the second skeleton may Plated with insulating coating, set with insulating sleeves, etc.
  • An anchor thorn 2729 is provided on the surface of the anchoring part 2720 , and the anchor thorn 2729 is provided proximal to the second conductive part 2760 .
  • the left atrial appendage occlusion and ablation device 2700B provided in Figures 29B to 29C is a modified embodiment based on the left atrial appendage occlusion and ablation device 2700 in Figure 29A.
  • a coating 2790B is provided between the second conductive part 2760B and the second frame of the anchoring part 2720B. It can be understood that the gap between the second conductive part 2760B and the second frame of the anchoring part 2720B is At least one of the following insulation designs may be used between the second conductive part 2760B and the second frame of the anchoring part 2720B.
  • the tube, or anchor 2720B may be made of an insulating material or the like.
  • the second conductive part 2760B is a wave electrode provided on the surface of the anchor part 2720B, and the wave troughs and crests of the second conductive part 2760B are consistent with the anchoring parts of the anchor part 2720B.
  • the rods 2724B are staggered, that is, the peaks and troughs of the second conductive portion 2760B are arranged between two adjacent three anchoring rods 2724B.
  • the second conductive part 2760B can be fixed to the covering film 2791 through the wave crest and the wave trough; in some embodiments, the second conductive part 2760B can be fixed to the covering film 2791B through the part between the wave crest and the wave trough, and can be further fixed to the anchor three Rod 2724B.
  • An anchor spur 2129B is provided on the surface of the anchoring part 2720B, and the anchor spur 2129B is disposed on the distal side of the second conductive part 2760B, thereby reducing the risk of discharge of the anchor spur 2129B during the ablation process.
  • at least one anchor thorn 2129B is provided on the outside of each of the three anchoring rods 2724B.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2800, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2800 includes a sealing portion 2810 disposed at the proximal end and a sealing portion 2810 disposed at the proximal end.
  • the distal anchoring portion 2820, the sealing portion 2810 and the anchoring portion 2820 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2800 provided in this embodiment and the left atrial appendage occlusion and ablation device 2700 provided in the twenty-seventh embodiment is that the structure of the first conductive part 2850 is different from that in the twenty-seventh embodiment.
  • the first conductive part 2850 is an electrode member disposed at the maximum circumferential and radial dimension of the sealing part 2810.
  • the electrode member is in the form of a ring electrode. Please refer to the aforementioned embodiments for specific descriptions of the ring electrode.
  • the ablation system of this embodiment includes a left atrial appendage occlusion and ablation device 2900, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 2900 includes a sealing portion 2910 disposed at the proximal end and a sealing portion 2910 disposed at the proximal end.
  • the distal anchoring portion 2920, the sealing portion 2910 and the anchoring portion 2920 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 2900 provided in this embodiment and the left atrial appendage occlusion and ablation device provided in the previous embodiment is that the anchoring part 2920 has a double-disc structure.
  • sealing part 2910 and the anchoring part 2920 may both be woven from braided wires.
  • the sealing portion 2910 is cylindrical or conical, and its radial size is larger than the left atrial appendage opening.
  • the first conductive part 2950 is a circular electrode and is disposed at the largest radial dimension of the sealing part 2910. In some embodiments, the first conductive part 2950 may also be disposed at other positions in the edge area.
  • the anchoring part 2920 includes a first anchoring part 2922 and a second anchoring part 2923 spaced apart in the axial direction.
  • the first anchoring part 2922 and the second anchoring part 2923 are both braided by braided wire and are cylindrical or tapered.
  • a connecting piece 2924 is provided between the first anchoring part 2922 and the second anchoring part 2923.
  • the connecting piece 2924 is flexible and/or elastic.
  • the second conductive part 2960 is an electrode member disposed at a larger radial dimension of the anchoring part 2922.
  • the specific electrode member is a ring electrode. Please refer to the aforementioned embodiments for the specific description of the ring electrode.
  • the second conductive part 2960 may be disposed at the second anchoring part 2923, or at a position with a larger radial dimension of the sealing part 2910, or at the connecting member 2924.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 3000, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 3000 includes a sealing portion 3010 disposed at the proximal end and a sealing portion 3010 disposed at the proximal end.
  • the distal anchoring portion 3020, the sealing portion 3010 and the anchoring portion 3020 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 3000 provided in this embodiment and the left atrial appendage occlusion and ablation device provided in the twenty-ninth embodiment lies in the structure of the first conductive part 3050 and the second conductive part 3060.
  • the first conductive part 3050 is at least part of the first skeleton in the sealing part 3010, preferably a part with a larger radial dimension. Preferably, the portion with the largest radial dimension is included.
  • the second conductive part 3060 is at least part of the skeleton of the anchoring part 3020 , preferably the part with a larger radial dimension of the anchoring part 3022 , preferably including the part with the largest radial dimension of the anchoring part 3022 .
  • the second conductive part 3060 may also be provided on the second anchoring part 3023, or on the sealing part 3010, or on the connecting piece 3024.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 3100, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 3100 includes a sealing portion 3110 disposed at the proximal end and a sealing portion 3110 disposed at the proximal end.
  • the distal anchoring portion 3120, the sealing portion 3110 and the anchoring portion 3120 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 3100 provided in this embodiment and the left atrial appendage occlusion and ablation device provided in the thirtieth embodiment lies in the structure of the sealing part 3110 and the anchoring part 3120, as well as the first conductive part 3150 and The structure of the second conductive part 3160.
  • the sealing part 3110 and the anchoring part 3120 may both be made by a weaving process.
  • the sealing part 3110 is in the shape of a double-layer mesh disk, and the diameter of the sealing part 3110 is larger than the diameter of the left atrial appendage orifice.
  • the anchoring part 3120 includes a first anchoring part 3122 and a second anchoring part 3123.
  • the first anchoring part 3122 and the second anchoring part 3123 may be in the shape of a single-layer network disk or a multi-layer network disk.
  • the first anchoring part 3122 is arranged on the anchoring surface. The near side of Part 23123.
  • a connecting piece 3124 and a connecting piece 3125 are connected between the sealing part 3110 and the anchoring part 3122.
  • the connecting piece 3124 and the connecting piece 3125 extend between the proximal end and the distal end.
  • the connecting piece 3124 is arranged along the axial direction of the left atrial appendage blocking ablation device 3100.
  • the connector 3124 may have a helical structure, and the connector 3124 is allowed to have a variable length, which enables the left atrial appendage occlusion and ablation device 3100 to be used for left atrial appendages with different shapes and sizes.
  • the connector 3124 is bendable, thereby allowing the LAA occlusion and ablation device 3100 to have different angles and directions, which also enables the LAA occlusion and ablation device 3100 to be used with LAA of different shapes and sizes.
  • Connector 3124 has a substantially constant or constant cross-section.
  • Connector 3125 includes a substantially inelastic or completely inelastic material such that connector 3125 prevents connector 3124 from extending beyond a predetermined length. Because the connector 3125 prevents the connector 3124 from extending beyond a predetermined length, the connector 3125 prevents the connector 3124 from overshooting during loading or removal of the LAA occlusion and ablation device 3100 into the LAA. Stretch. Two connecting parts 3125 or more connecting parts 3125 may be provided around the connecting part 3124.
  • the first conductive part 3150 is at least part of the first skeleton in the sealing part 3110, preferably a part with a larger radial dimension, preferably including a part with the largest radial dimension.
  • the second conductive part 3160 is at least part of the second skeleton in the two anchoring parts 3123, preferably the part with a larger radial dimension of the two anchoring parts 3123, and preferably includes the part with the largest radial dimension of the two anchoring parts 3123.
  • the second conductive part 3160 is at least part of the second skeleton in the anchoring part 3122, or is provided on the connecting piece 3124 and/or the connecting piece 3125.
  • the connector 3124 and the connector 3125 can be used as conductive connectors for transmitting electrical energy.
  • the ablation system of this embodiment is a left atrial appendage occlusion and ablation device 3200, which is used to seal and ablate the left atrial appendage.
  • the left atrial appendage occlusion and ablation device 3200 includes a sealing portion 3210 disposed at the proximal end and a sealing portion 3210 disposed at the proximal end.
  • the distal anchoring portion 3220, the sealing portion 3210 and the anchoring portion 3220 are connected to each other.
  • the main difference between the left atrial appendage occlusion and ablation device 3200 provided in this embodiment and the left atrial appendage occlusion and ablation device 3100 provided in the thirty-first embodiment lies in the structure of the second conductive part 3260.
  • the second conductive part 3260 is an electrode member provided on the surface of the anchoring part 3222, and the electrode member is in the form of a circular electrode.
  • the second conductive portion 3260 is preferably provided at a portion of the anchoring portion 3222 with a larger radial dimension, preferably at a portion with the largest radial dimension of the anchoring portion 3222 .
  • the second conductive part 3260 is an electrode member disposed on the surface of the two anchoring parts 3222 , and is preferably disposed on a portion with a larger radial dimension of the two anchoring parts 3223 .
  • FIG. 35 is a schematic structural diagram of the ablation system 3300 provided in the 33rd embodiment.
  • Figure 36 is a schematic structural diagram of the ablation system 3300 provided in the 33rd embodiment implanted at the left atrial appendage.
  • the ablation system 3300 includes a support body 3310 , a transporter 3320 and an ablation member 3330 .
  • the support body 3310 is used to be implanted into the target tissue, such as the opening of the left atrial appendage and other locations where ablation operations are required.
  • the transporter 3320 is used to transport the support 3310 to a target tissue, such as the opening of the left atrial appendage or other target tissue.
  • the target tissue includes but is not limited to myocardial tissue.
  • the ablation member 3330 is used to electrically ablate the target tissue wall. The tissue used by the ablation member 3330 to ablate may be at a different location from the tissue released by the support 3310 .
  • the support body 3310 adopts a single disk structure and is in the shape of a column as a whole.
  • the support body 3310 is a hollow grid structure made by weaving and/or cutting processes.
  • the support body 3310 includes a sealing portion 3311 and an anchoring portion 3312 that are connected. After the support body 3310 is released to the left atrial appendage 10, the sealing portion 3311 is located distal to the mouth of the left atrial appendage. An opening is formed on the distal side of anchor portion 3312.
  • An anchor thorn 3313 is provided on the outer wall of the anchoring part 3312, and the anchor thorn 3313 is used for anchoring on the inner wall of the left atrial appendage.
  • a plurality of anchor thorns 3313 are evenly arranged around the outer wall surface of the anchoring portion 3312, and different arrangement methods can be adopted according to the structure of the anchor thorns 3313.
  • the anchor thorn 3313 can be directly fixed on the anchoring portion 3312, specifically by welding.
  • the anchor thorn 3313 can also be fixedly connected to the anchoring portion 3312 through a steel sleeve.
  • the anchor thorn 3313 and the anchoring part 3312 may also have an integral structure, that is, the anchor thorn 3313 is directly extended from the anchoring part 3312.
  • the ablation member 3330 includes a first conductive part 3331 and a second conductive part 3332.
  • the first conductive part 3331 and the second conductive part 3332 are used to transmit pulse ablation energy with different polarities to the target tissue to achieve tissue ablation.
  • the first conductive part 3331 is disposed on the support body 3310.
  • the first conductive part 3331 is electrically connected to the external pulse ablation source through the conveyor 3320.
  • the second conductive part 3332 is disposed on the conveyor 3320.
  • the second conductive part 3332 can face each other. Move on the support body 3310 to release from the proximal end of the support body 3310.
  • the side wall of the support body 3310 is arc-shaped, and the position with the largest radial dimension of the support body 3310 is used to radially abut against the inner wall tissue of the left atrial appendage, resulting in better wall adhesion.
  • a first conductive part 3331 is provided at the position with the largest radial dimension of the support body 3310, which facilitates the first conductive part 3331 to adhere to the wall and ensures the ablation effect.
  • the largest radial dimension of the support body 3310 is between its proximal end and distal end, and is close to the proximal end.
  • the support body 3310 adopts a single disk structure, and the position with the largest radial dimension of the support body 3310 is located between the proximal end and the distal end of the support body 3310, it is convenient for the support body 3310 to be implanted and fixed in the inner cavity of the left atrial appendage.
  • the radial dimensions of the side walls at different axial positions of the support body are the same.
  • At least part of the first conductive part 3331 and/or the second conductive part 3332 can be used to collect tissue physiological signals, that is, the ablation member 3330 has ablation and mapping functions.
  • some components in the first conductive part 3331 may be used only for mapping and have no ablation effect.
  • some components in the first conductive part 3331 are used for mapping, and some components have an ablation function.
  • at least some components of the first conductive portion 3331 are used for both mapping and ablation.
  • some components in the second conductive part 3332 may be used only for mapping and have no ablation effect.
  • some components of the second conductive part 3332 are used for mapping, and some components have an ablation effect.
  • at least some components of the second conductive portion 3332 are used for both mapping and ablation.
  • Delivery 3320 includes an inner sheath 3321 and an ablation catheter 3323.
  • the inner sheath tube 3321 is connected to the support body 3310.
  • the transporter 3320 includes an outer sheath 3322 that is sleeved outside the inner sheath 3321.
  • the outer sheath 3322 and the inner sheath 3321 are relatively movable.
  • the distal end of the inner sheath 3321 is connected to the support 3310.
  • the ablation catheter 3323 The proximal end is connected to the distal end of the outer sheath 3322.
  • the ablation catheter 3323 can be recovered in the outer catheter (not shown) that is installed outside the outer sheath 3322.
  • Ablation catheter 3323 is used for release proximal to seal 3311.
  • the ablation catheter 3323 is provided with a second conductive part 3332. Specifically, the ablation catheter 3323 includes multiple support rods 3324 disposed on the distal side of the outer sheath. The multiple support rods 3324 are umbrella-shaped after being released at the proximal end of the support body 3310, forming an umbrella-shaped frame.
  • the ablation catheter 3323 includes a plurality of support rods 3324 arranged radially around its axis.
  • the proximal ends of the multiple support rods 3324 are combined with the distal end of the outer sheath 3322.
  • each support rod 3324 is in the shape of an arc protruding toward the support body 3310.
  • One end of each support rod 3324 away from its proximal end is a free end, and the free end is used to extend toward the proximal end.
  • the second conductive part 3332 is provided on the support rod 3324.
  • the second conductive part 3332 may be part or all of the support rod 3324 , or an electrode member provided on the support rod 3324 .
  • an electrode member is provided at the circumferential end of each support rod 3324.
  • the radial size of the second conductive part 3332 is larger and larger than the radial size of the first conductive part 3331, which facilitates the penetration of the characteristic electric field line E. Through oral tissues. It can be understood that the number of electrode members on the support rods 3324 can be adjusted as needed, and no electrode members may be provided on some support rods 3324.
  • the second conductive part 3332 is disposed in the circumferential edge area with a larger radial dimension of the ablation catheter, it is easier for the second conductive part 3332 to abut against the proximal tissue of the left atrial appendage mouth after release.
  • the position with the largest radial size of the support body 3310 is located between its proximal end and distal end. In this way, when the support body 3310 is implanted into the left atrial appendage, the sealing portion 3311 of the support body 3310 is used to implant into the distal side of the left atrial appendage mouth to support the support body 3310.
  • the sealing portion 3311 of the body 3310 will not cover the mouth of the left atrial appendage, thus preventing the support body 3310 and the umbrella-shaped frame from interfering with each other.
  • the radial size of the annular structure surrounding the second conductive part 3332 is larger than the radial size of the annular structure surrounding the first conductive part 3331, that is, the second Among the first conductive part 3331 and the second conductive part 3332, the radial dimension of the annular structure of the proximal conductive part is larger than the radial dimension of the annular structure of the distal conductive part, so that the characteristic electric field line E
  • the distal side is tilted toward the axis of the support body to facilitate at least one characteristic electric field line between the first conductive part 3331 and the second conductive part 3332 to pass through the left atrial appendage tissue outside the receiving part, ensuring the ablation effect.
  • the receiving portion is a portion where the support body 3310
  • first conductive part 3331 and the second conductive part 3332 can be various forms of electrodes provided on the support body 3310 or the support rod 3324, such as point electrodes, rod electrodes, arc electrodes, and ring electrodes. , at least one of wave electrodes.
  • First conductive part 3331 It may also be at least a part of the support body 3310.
  • the second conductive part 3332 may be at least a part of the support rod 3324.
  • the support body 3310 may be a hollow grid structure made of conductive metal material through weaving and/or cutting processes.
  • the first conductive part 3331 is at least a part of the support body 3310, or may be the entire support body 3310.
  • the support rod 3324 of the ablation catheter 3323 is made of conductive metal material through weaving and/or cutting processes; the second conductive portion 3332 is at least a part of the support rod 3324, or may be the entire support rod 3324.
  • the number of each of the first conductive parts 3331 and the second conductive parts 3332 may be multiple. As shown in Figure 33, a plurality of first conductive parts 3331 are provided on the support body 3310. The specific number is two, which are respectively provided at the sealing part 3311 and the anchoring part 3312. Preferably, the two first conductive parts 3331 are used for Pulse ablation energy of opposite polarity is transmitted and forms an ablation circuit. It can be understood that the plurality of first conductive parts 3331 may all be provided on the sealing part 3311 or all be provided on the anchoring part 3312. In an embodiment in which the first conductive part 3331 includes multiple electrodes, the multiple electrodes in the first conductive part 3331 may be spaced apart or in contact with each other.
  • the plurality of electrodes of the second conductive part 3332 may be spaced apart from each other or connected to each other.
  • the second conductive part 3332 includes multiple electrodes.
  • multiple second conductive parts 3332 may be provided, and each second conductive part 3332 includes at least one electrode or at least one section of a support rod. .
  • all of second conductive portion 3332 is used for mapping.
  • the ablation system 3300 provided in this application can achieve pulse ablation of target tissue through the cooperation of the first conductive part 3331 and the second conductive part 3332.
  • the following description takes the ablation system 3300 as a left atrial appendage blocking and ablation system as an example, which is used to block and ablate the left atrial appendage 10 .
  • the ablation system includes a left atrial appendage occlusion ablation device and a delivery device 3320.
  • the left atrial appendage occlusion and ablation device includes a support body 3310 and a first conductive portion 3331 in an ablation member 3330.
  • the support body 3310 is connected to the conveyor 3320, and the first conductive part 3331 is connected to the pulse ablation instrument through the conveyor 3320.
  • the first conductive portion 3331 is connected to the pulse ablation instrument via a cable through the conveyor 3320.
  • a coating is provided on the support body 3310, and the coating is used to block the thrombus in the left atrial appendage from flowing out to the left atrium.
  • the first conductive part 3331 and the second conductive part 3332 are both disposed on the support body 3310.
  • the two conductive parts are used to transmit ablation electrical energy with the same or different parameters, such as for transmitting ablation energy with different polarities. electrical energy.
  • the support body 3310 is provided with a first conductive part
  • the second conductive part is provided on the delivery device 3320, such as the ablation catheter of the delivery device 3320 provided on the proximal end of the support body 3310.
  • an ablation catheter provided with a second conductive portion is used for release distal to support body 3310.
  • the second conductive part is provided independently of the support body 3310 and the transporter 3320, and is used to adhere to the surface of the living body during the ablation process.
  • the first conductive part 3331 and the second conductive part 3332 meet the parameters provided in the previous embodiment.
  • the distance between the first conductive part 3331 and the second conductive part 3332 is 3 mm from their respective surfaces.
  • the electric field intensity generated at the position is greater than 400V/cm.
  • the ablation system 3300 is used to ablate cardiac tissue other than the left atrial appendage 10.
  • the thickness of the pulmonary vein is generally 2 mm, ensuring that during the ablation process, the intensity of the electric field generated by it is 2 mm from the surface of the ablation member 3330.
  • the field strength is greater than the myocardial threshold, such as greater than 400V/cm, thus facilitating transmural ablation.
  • the pulse voltage range used by the ablation element 3330 (the first conductive part and the second conductive part) is 500V to 4000V, and the discharge of the first conductive part 3331
  • the area is 15mm2 ⁇ 4700mm2, and the discharge area of the second conductive part 3332 is 15mm2 ⁇ 4700mm2.
  • the value range of the discharge area refers to the sum of all discharge areas (electrode elements or skeleton) of the conductive part.
  • the distance between the two closest points on the surface of the first conductive part 3331 and the second conductive part 3332 ranges from 1 mm to 45 mm.
  • the distance between the first conductive part 3331 and the second conductive part 3332 may be further limited to 3 mm to 22 mm. Within this range, it is possible to facilitate the partial overlap of the ablation zones of the two conductive parts.
  • the ablation system is used to ablate myocardial tissue.
  • the area where the electric field intensity formed around the first conductive part 3331 is greater than the myocardial threshold intensity is the first ablation zone.
  • the area where the electric field intensity formed around the second conductive part 3332 is greater than the myocardial threshold intensity is the third ablation area.
  • Ablation zone The size of the ablation zone is larger after the two ablation zones partially overlap in the axial direction.
  • the support body 3310 in Figure 35 is provided with two first conductive parts 3331. In some embodiments, one of them can be selected and used according to actual application requirements.
  • the ablation zone corresponds to an electric field distribution area with an electric field intensity greater than or equal to 400V/cm
  • the ablation zone is set around the surface of the conductive part, and the two ablation zones are in the axial direction
  • the axial size of the ablation zone formed by partial overlap is larger than that of any single ablation zone. This makes it easier to concentrate the energy of the two ablation zones to ablate one part and improve the ablation success rate of the area to be ablated.
  • the circumferential edge area of the sealing portion 3311 has a problem of poor adhesion in some locations, because the ablation member 3330 has a larger ablation hole in the axial direction. zone, it is easier to form a transmural ablation around the sealing portion 3311 than two separate ablation zones with smaller axial dimensions.
  • the ablation zone partially overlaps and has a proximal part and a distal part in the axial direction. Even if the proximal part has poor adhesion, its outer edge cannot cover the outer wall of the left atrial appendage, and the distal part may cover the left atrial appendage. outer wall, thereby reducing wall adhesion due to the release of the seal 3311
  • the influence of conditions on the ablation effect of the blocking ablation system 3300 improves the success rate of system ablation.
  • the first conductive part 3331 is provided in the sealing part 3311, and the ablation zone formed by partially overlapping the first ablation zone and the second ablation zone is distributed in the left atrial appendage orifice 11, so as to ablate the left atrial appendage orifice 11. .
  • the oral tissue of the left atrial appendage has a smooth surface and regular shape.
  • the first conductive part 3331 is relatively easy to adhere to the wall and has a relatively uniform thickness.
  • the ablation zone facilitates continuous transmural ablation in the oral area.
  • the wall thickness of the left atrial appendage is generally 3 mm, the distance between the boundary of the two overlapping ablation zones and the surface of the conductive part is large and exceeds the wall thickness of the left atrial appendage, so transmural ablation can be achieved.
  • the operating method of the ablation system 3300 in this embodiment includes the following steps:
  • Step A Use the transporter 3320 to transport the left atrial appendage occlusion and ablation device to the left atrial appendage opening and release it to seal the left atrial appendage opening. Specifically, after the left atrial appendage occlusion and ablation device is released to the left atrial appendage 10, the inner sheath 3321 remains connected to the occlusion ablation device and releases the second conductive part 3332 (ablation catheter 3323); wait until the second conductive part 3332 is close to the left atrial appendage 10.
  • the tissue proximal to the mouth of the atrial appendage When the tissue proximal to the mouth of the atrial appendage is fixed, the position of the ablation catheter 3323 is fixed, and the pulse ablation source is turned on at the same time; under the action of pulse energy, at least one characteristic electric field line E formed by the first conductive part 3331 and the second conductive part 3332 passes through the mouth. tissue to facilitate transmural ablation in the mouth. Destroy the homeostasis of the internal and external environment of the cells, achieve electrical isolation, and ensure that electrophysiological signals cannot be transmitted between the left atrial appendage 10 and the left atrium 12 located on both sides of the ablated tissue, thereby achieving the purpose of treating atrial fibrillation. Release the connecting cable after ablation is complete.
  • Step B Withdraw the ablation catheter 3323 to complete the operation.
  • Step C The ablation catheter 3323 performs ablation alone. Specifically, under the guidance of DSA contrast imaging or ultrasound, the ablation catheter 3323 is positioned to the left atrial appendage orifice 11, the second conductive part 3332 is brought close to the tissue proximal to the left atrial appendage orifice, the position of the ablation catheter 3323 is fixed, and at the same time, the pulse ablation source is turned on. , the electrodes of the second conductive part 3332 are used to transmit pulse ablation energy with different polarities.
  • the plurality of electrodes of the second conductive part 3332 form a ring shape to facilitate the formation of a transmural annular ablation zone in the left atrial appendage 10, the left atrial appendage ostium 11 and the proximal side of the left atrial appendage ostium, the pulmonary veins and the atrium.
  • Step C can be performed before step A, and/or between step A and step B.
  • the release sequence of the ablation catheter 3323 and the occlusion ablation device can be adjusted as needed, and the release sequence of the two has no mutual restriction.
  • step C may be omitted.
  • Figure 37 is a schematic structural diagram of an ablation system 3400 according to the thirty-fourth embodiment of the present application.
  • the ablation system 3400 of this embodiment is similar to the ablation system 3300 of the thirty-third embodiment. Please refer to the above description of the thirty-third embodiment for the same parts, which will not be described again here.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 3423 includes an outer sheath 3422 and a plurality of support rods disposed at the distal end of the outer sheath 3422.
  • the first conductive portion 3431 is provided on the proximal outer peripheral wall of the support body 3410 .
  • the second conductive part 3432 is provided on the plurality of support rods.
  • the second conductive part 3432 may be a part of the plurality of support rods, may be all of the plurality of support rods, or may be an electrode member provided on the plurality of support rods.
  • Each of the plurality of support rods forms a support ring, and the plurality of support rings are arranged sequentially in the circumferential direction.
  • the projection of each support ring on a plane perpendicular to the axis of the support body is annular.
  • the annular shape is a sector.
  • the annular shape can be a circular annular shape, an elliptical annular shape, a partial annular shape, or Are other regular or irregular rings.
  • the projections of adjacent support rings on a plane perpendicular to the axis of the support body have overlapping portions. In other embodiments, the projections of adjacent support rings on the plane do not coincide, or the overlapping portion is smaller or larger.
  • the two ends of the support rod do not overlap in the axial direction, that is, they are staggered in the axial direction, thereby increasing the support performance of each support ring.
  • the two ends of the support ring are at the same position in the axial direction, and may be connected together, or may be spaced apart.
  • the edge part of the support ring can better adhere to the tissue wall to ensure the effect of ablation and mapping.
  • the support body 3410 adopts a single disk or multi-disk structure
  • the second conductive part 3432 is provided on the conveyor 3420.
  • the second conductive part 3432 is movable relative to the support body 3410.
  • the second conductive part 3432 is used to be released on the proximal side of the support body 3410.
  • the first conductive part 3431 is disposed adjacent to the proximal end of the support body 3410. The distance between the first conductive part 3431 and the second conductive part 3432 can be adjusted to be closer, so that the ablation catheter at the distal end of the conveyor 3420 and the first conductive part 3431 on the sealing part 3410 can cooperate effectively.
  • Figure 38 is a schematic structural diagram of an ablation system 3500 according to the thirty-fifth embodiment of the present application.
  • the ablation system 3500 of this embodiment is similar to the ablation system 200 of the thirty-fourth embodiment. Please refer to the above description of the thirty-fourth embodiment for the same parts, which will not be described again here.
  • the main difference between this embodiment and the thirty-fourth embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 3523 includes a network disk structure located at the distal end of the outer sheath 3522.
  • the network disk structure can be braided or cut. Made by cutting process.
  • the network disk structure is a double-layer network disk, that is, in the axis direction of the network disk structure (the up and down direction in the figure) the network disk structure includes two layers of woven mesh, and the two layers of woven mesh are connected to each other at the circumferential edge.
  • the network disk structure is a single-layer network disk, that is, the network disk structure only includes a single layer of woven mesh in the axial direction of the network disk structure (the up and down direction in the figure).
  • the second conductive part 3532 is provided on the woven mesh disk.
  • the first conductive portion 3531 is provided on the proximal outer peripheral wall of the support body 3510 .
  • the second conductive part 3532 can be part of the mesh disk structure, or the entire mesh disk structure, so that the entire braided mesh disk can serve as an electrode to transmit ablation energy to the tissue.
  • the second conductive part 3532 may be an electrode disposed on the mesh structure.
  • Figure 39 is a schematic structural diagram of an ablation system 3600 according to the thirty-sixth embodiment of the present application.
  • the ablation system 3600 of this embodiment is similar to the ablation system 3300 of the thirty-third embodiment in FIG. 35.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 3623 is an inner sheath 3621, and the distal end of the inner sheath 3621 is detachably connected to the support body 3610.
  • the inner sheath 3621 is in the shape of a rod or a tube, and the second conductive part 3632 is provided on the outer peripheral side wall of the inner sheath 3621.
  • the second conductive part 3632 may be an electrode or an exposed part of the conductive member in the inner sheath 3621.
  • the first conductive portion 3631 is provided on the proximal outer peripheral wall of the support body 3610 .
  • Figure 40 is a schematic structural diagram of an ablation system 3700 according to the thirty-seventh embodiment of the present application.
  • the ablation system 3700 of this embodiment is similar to the ablation system 100 of the thirty-third embodiment.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the ablation catheter is different.
  • the delivery device 3720 includes an outer sheath tube 3722 and an inner sheath tube 3721 passing through the inner cavity of the outer sheath tube 3722.
  • the ablation catheter 4023 in the delivery device 3720 is a spherical mesh provided at the distal end of the outer sheath tube 3722. structure.
  • the second conductive part 3732 is at least one wavy electrode disposed in the circumferential edge area of the spherical grid structure, so that the second conductive part 3732 is close to the tissue during the ablation process.
  • the spherical mesh structure can be made by weaving or cutting process, and the spherical mesh structure can expand and contract radially.
  • the spherical grid structure can be a regular or irregular spherical shape such as a sphere or an ellipsoid.
  • the first conductive portion 3731 is provided on the proximal outer peripheral wall of the support body 3710 .
  • the transporter 3720 adopts a double-layer sheath.
  • the inner sheath 3721 is inserted into the outer sheath 3722 and can be connected to the support body 3710 as a delivery catheter.
  • the distal end of the spherical grid structure is connected to the distal end of the inner sheath 3721.
  • the diameters of the spherical mesh structure and the second conductive portion 3732 can be adjusted through the inner and outer sheaths. Specifically, the adjustment can be made by fixing the inner sheath 3721, advancing the outer sheath 3722 distally, and/or pulling the inner sheath 3721.
  • the spherical mesh structure is compressed, thereby increasing the radial size of the second conductive portion 3732 and making its edge abut against the tissue outside the left atrial appendage mouth.
  • the axial length of the spherical grid structure is increased by adjusting the inner and outer sheaths until the spherical grid structure can be condensed for easy delivery.
  • the spherical grid structure can be a regular or irregular closed structure such as a sphere, an ellipsoid, or a column.
  • Figure 41 is a schematic structural diagram of an ablation system 3800 according to the thirty-eighth embodiment of the present application.
  • the ablation system 3800 of this embodiment is similar to the ablation system 3700 of the thirty-seventh embodiment. Please refer to the above description of the thirty-seventh embodiment for the same parts, which will not be described again here.
  • the main difference between this embodiment and the thirty-seventh embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 3823 is a balloon provided on the delivery device 3820 . After the interior of the balloon is filled with medium, it expands outside the mouth of the left atrial appendage. The filled balloon is disk-shaped. The second conductive part 3832 is provided on the peripheral edge of the filled balloon. After the ablation is completed, the balloon is recovered to in the conveyor. A first conductive portion 3831 is provided on the proximal circumferential outer surface of the support body 3810 .
  • Figure 42 is a schematic structural diagram of an ablation system 3900 according to the thirty-ninth embodiment of the present application.
  • the ablation system 3900 of this embodiment is similar to the ablation system 3300 of the thirty-third embodiment. Please refer to the above description of the thirty-third embodiment for the same parts, which will not be described again here.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the ablation catheter is different.
  • the delivery device 3920 includes an outer sheath 3921 and an ablation catheter 3923 disposed at the distal end of the outer sheath 3921.
  • the ablation catheter 3923 is annular, and the second conductive portion 3932 is provided on the ablation catheter 3923.
  • the ablation catheter 3923 is wound around the axis of the outer sheath 3921 to form a planar ring or a three-dimensional ring.
  • the ablation catheter 3923 is wound around the axis of the outer sheath 3921 at least once, and may be multiple times.
  • the second conductive part 3932 includes a plurality of parts spaced apart along the length direction of the ablation catheter 3923, such as sequentially spaced apart along the axial direction of the ablation catheter 3923.
  • the second conductive part 3932 may be part or all of the ablation catheter 3923, and may be arranged at intervals or continuously.
  • a first conductive portion 3931 is provided on the proximal circumferential outer surface of the support body 3910 .
  • Figure 43 is a schematic structural diagram of an ablation system 4000 according to the fortieth embodiment of the present application.
  • the ablation system 4000 of this embodiment is similar to the ablation system 3300 of the thirty-third embodiment provided in Figure 35.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the ablation catheter is different.
  • the delivery device 4020 includes an inner sheath 4021, an outer sheath 4022, and an ablation catheter 4023.
  • Ablation catheter 4023 includes a plurality of support rods 4024.
  • the inner sheath 4021 is inserted into the outer sheath 4022.
  • the distal ends of each support rod 4024 are combined together and connected to the distal end of the inner sheath tube 4021, and the proximal ends of each support rod 4024 are combined together and connected to the distal end of the outer sheath tube 4022.
  • the support rod 4024 is in a spiral shape to facilitate deformation during loading and release.
  • the radial size of the support rod 4024 is changed by pulling the inner sheath 4021 of the delivery device 4020 and/or pushing the outer sheath 4022 distally. That is, the support rod 4024 is compressed in the axial direction, and the size of the support rod 4024 is expanded in the radial direction.
  • the spiral support rod 4024 easily adapts to the tissue shape at the mouth, and adheres to the tissue after deformation, without causing great pressure on the tissue. force.
  • the second conductive part 4032 provided on the spiral support rod 4024 is used to ablate tissue.
  • a first conductive portion 4031 is provided on the circumferential outer surface of the support body 4010 close to the proximal end.
  • each support rod 4024 After the radial dimension of each support rod 4024 is compressed to a certain extent, the spiral support rods 4024 are easily stacked on each other in the axial direction, forming a structure for abutting the outer (proximal) tissue of the mouth, that is, forming a stable structure. Disk structure.
  • a plurality of electrode members in the second conductive portion 4032 are spaced on each support rod 4024.
  • the second conductive portion 4032 is provided at least in a region with a larger radial dimension when the support rod 4024 is in an axially compressed state, so as to facilitate ablation of tissue in the edge region outside the mouth.
  • each support rod 4024 can be recovered in the outer sheath 4022.
  • the support rod 4024 may also have no helix angle.
  • Figure 44 is a schematic structural diagram of an ablation system 4100 according to the forty-first embodiment of the present application.
  • the ablation system 4100 of this embodiment is similar to the ablation system 4000 of the fortieth embodiment. Please refer to the above description of the fortieth embodiment for the same parts, which will not be described again here.
  • the main difference between this embodiment and the fortieth embodiment is that the structure of the support body is different.
  • the support body 4110 has a single-disk columnar structure and can be made by weaving or cutting technology.
  • a first conductive part 4131 is provided on the proximal outer periphery of the support body 4110, and the first conductive part 4131 is a circular electrode.
  • the second conductive part 4132 is provided on the conveyor 4120, and the first conductive part 4131 and the second conductive part 4132 cooperate with each other to perform ablation.
  • Figure 45 is a schematic structural diagram of the ablation system 4200 according to the forty-second embodiment of the present application
  • Figure 46 is a schematic structural diagram of the principle of the ablation system performing ablation on left atrial appendage tissue.
  • the ablation system 4200 of this embodiment is similar to the ablation system 3300 of the thirty-third embodiment in FIG. 35.
  • the main difference between this embodiment and the thirty-third embodiment is that the structure of the support body and the arrangement of the conveyor are different.
  • the structure of the support body 4210 and the first conductive part 4231 of the ablation system 4200 provided in this embodiment is consistent with the support body and the first conductive part 2150 provided by the left atrial appendage occlusion and ablation device 2100 provided in Figures 23A and 23B.
  • the second conductive part 4232 is provided on the conveyor, and the second conductive part 4323 can move relative to the support body 4210 for release on the distal side of the support body 4210 .
  • the support body 4210 has a double disk structure.
  • the structure of the support body 4210 is similar to the structure shown in FIG. 21 and FIG. 22 .
  • the support body 4210 includes a sealing portion 4211 and an anchoring portion 4212, which are connected through a connecting piece 4217 to achieve electrical isolation.
  • a channel is formed along the axis direction. The distal end of the ablation catheter 4223 passes through the channel and can be released distal to the anchoring portion 4212.
  • the sealing portion 4211 is trapezoidal and includes a distal disk 4218 facing the anchoring portion 4212, a proximal disk 4219 facing away from the anchoring portion 4212, and a waist 4220 between the distal disk 4218 and the proximal disk 4219.
  • the proximal disk surface 4219 and the distal disk surface 4218 are generally planar, and the waist 4220 is connected between the proximal disk surface 4219 and the distal disk surface 4218, and the waist 4220 is cone-shaped.
  • the first conductive part 4231 is provided at least in an edge area with a larger radial dimension of the sealing part 4211, such as the waist part 4220.
  • the first conductive portion 4231 is provided at the portion of the sealing portion 4211 that has the largest radial dimension in the circumferential direction.
  • the first conductive part 4231 is provided on the waist 4220 and the proximal disk surface 4219 (the dotted line frame part in the figure), or is provided on the waist part 4220, the proximal disk surface 4219 and at least a part of the distal disk surface 4218 .
  • the first conductive part 4231 is part of the first frame in the sealing part 4211. The remaining surface of the sealing part 4211 that is not the first conductive part 4231 may be subjected to insulation treatment.
  • the sealing portion 4211 is consistent with the structure of the sealing portion 2110 in Figures 23A and 23B, and is consistent with the sealing structure provided in Figures 21 and 22.
  • the main difference between the seals is the grid form.
  • the mesh size of the proximal part and the distal part of the sealing part 4211 is different. Specifically, the meshes of the proximal part of the sealing part 4211 are smaller and more numerous, while the distal part of the sealing part 4211 has larger meshes and a smaller number.
  • the first skeleton of the small mesh in the sealing part 4211 is used as the first conductive part, and the surface of the first skeleton of the large mesh in the sealing part 4211 is insulated.
  • the small mesh part is formed by a dense mesh weaving process
  • the large mesh part is obtained by extending the multiple braided wires in the small mesh part into bundles, and the multiple braided wires in each bundle of braided wires are fixed to each other.
  • there may be friction between two bundles of braided wires. to facilitate insulation on the first skeleton in a large grid area.
  • the sealing part 4211 can also adopt other insulation methods, or add other insulation methods, such as providing an insulating sleeve, providing a coating, etc.
  • the structure of the anchoring part 4212 is the same as in FIG. 21 and FIG. 22 and is in a disk shape.
  • the anchoring part 4212 includes a plurality of anchoring rods, and the anchoring rods include a first anchoring rod 4213, a second anchoring rod 4214, a third anchoring rod 4215 and a fourth anchoring rod 4216 that are connected in sequence.
  • the proximal end of the anchor rod 4213 is connected to the insulating connector 4217, and the anchor rod 4213 extends between the proximal end and the distal end.
  • Two adjacent two anchoring rods 4214 are connected at one end away from the three anchoring rods 4215 and connected to the corresponding one anchoring rod 4213.
  • the three anchoring rods 4215 extend between the proximal end and the distal end and are located on the outer peripheral side of the anchoring portion 4212 for abutting against the inner wall of the left atrial appendage.
  • the proximal ends of the three anchoring rods 4215 are connected to the corresponding two anchoring two rods 4214.
  • the two anchoring rods 4214 are connected end to end in the circumferential direction to form a zigzag structure.
  • One end of the four anchoring rods 4216 away from the three anchoring rods 4215 extends in the axial direction and extends toward the distal end.
  • Connecting the ends of two adjacent four anchoring rods 4216 away from the three anchoring rods 4215 can improve the mechanical properties of the anchoring part 4212 and avoid the radial deformation of the adjacent four anchoring rods 4216 in the anchoring part 4212 In the process of hooking each other, the reliability of the support body 4210 is improved.
  • Two point-shaped electrodes are provided at intervals on each of the three anchoring rods 4215.
  • the structure of the ablation catheter 4223 is the same as that of the ablation catheter provided in Figure 35, using an umbrella-shaped frame body.
  • the ablation catheter 4223 includes a plurality of support rods 4224 arranged radially around its axis.
  • An electrode member is provided at the circumferential end of each support rod 4224, thus forming a second conductive portion 4232 at the circumferential end of the umbrella-shaped frame.
  • the difference between the ablation catheter 4223 in this embodiment and the ablation catheter in FIG. 35 is that the ablation catheter 4223 is used for release on the distal side of the support body 4210 .
  • the support body 4210 is transported to the left atrial appendage opening through the conveyor 4240, the waist 4220 of the sealing portion 4211 abuts against the left atrial appendage opening, and the first conductive portion 4231 on the waist 4220 abuts against the left atrial appendage opening. It leans against the tissue proximal to the left atrial appendage, and the anchoring three rods 4215 abut against the inner wall of the left atrial appendage.
  • the pulse ablation source is turned on, the characteristic electric field lines between the first conductive part 4231 and the second conductive part 4232 pass through the oral tissue, facilitating transmural ablation in the oral cavity.
  • the support body 4210 is released and the ablation catheter 4223 is withdrawn.
  • the distal end of the ablation catheter 4223 in this embodiment passes through the axial channel of the support body 4210 and can be released on the distal side of the anchoring portion 4212.
  • the support body adopts the structure provided in other embodiments.
  • the release position of the second conductive part on the conveyor can be adaptively changed according to the specific structure of the support body.
  • the anchoring part of the support body is cup-shaped.
  • the distal end is open, and the second conductive part can be released on the distal side of the support body.
  • the second conductive part can be released in the anchoring part, the distal end of the support body, or beyond the distal end of the support body.
  • Figure 47 is a schematic structural diagram of an ablation system 4300 according to the forty-third embodiment of the present application.
  • the ablation system 4300 of this embodiment is similar to the ablation system 4200 of the forty-second embodiment.
  • the support structure and the arrangement of the ablation catheter are the same.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the structure of the ablation catheter 4323 is the same as the structure of the ablation catheter of the thirty-fourth embodiment corresponding to Figure 37.
  • the second conductive part 4332 is provided on the support ring, and the structure of the support ring will not be described again.
  • the distal end of the ablation catheter 4323 of this embodiment passes through the axial channel of the support body 4310 and can be released on the distal side of the anchoring part 4312.
  • the ablation catheter of the thirty-fourth embodiment is released proximal to the sealing portion.
  • Figure 48 is a schematic structural diagram of an ablation system 4400 according to the forty-fourth embodiment of the present application.
  • the ablation system 4400 of this embodiment is similar to the ablation system 4200 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the structure of the ablation catheter 4423 is the same as the structure of the ablation catheter 3523 of the thirty-fifth embodiment corresponding to Figure 38.
  • the ablation catheter 4423 also adopts a mesh disk structure, and the second conductive part 4432 is provided on the mesh disk structure.
  • the first conductive part 4431 is provided on the sealing part 4411. What is different from the ablation system of the thirty-fifth embodiment is that the distal end of the ablation catheter 4423 of this embodiment passes through the axial channel of the support body 4410 and can be released on the distal side of the anchoring part 4412.
  • the ablation catheter of the thirty-fifth embodiment is released proximal to the sealing portion.
  • 49A and 49B are schematic structural diagrams of the ablation system 4500 according to the forty-fifth embodiment of the present application.
  • the surface of the anchoring part 4512 of the ablation system 4500 in this embodiment is provided with a coating 4590.
  • the coating 4590 is used to achieve flow blocking and insulation between the second conductive part 4532 and the anchoring part 4512.
  • the ablation system 4500 of this embodiment is similar to the ablation system 4000 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 4523 in the delivery state, is linearly received in the outer catheter of the delivery device. After the ablation catheter 4523 is released from the outer catheter distal to the anchoring portion 4512, the ablation catheter 4523 moves away from the support. One end of the body 4510 is bent and extended in a radially outward direction, and may be coiled into a ring shape (the shape of the ablation catheter 4823 in Figure 52). In some embodiments, the ablation catheter 4523 is also linear after being released from the outer catheter, and the second conductive portion 4532 is disposed on the side wall of the ablation catheter 4523. The first conductive part 4531 is provided on the sealing part 4511. The second conductive part 4532 may be an electrode or a part of the ablation catheter 4523 where the conductive part is exposed.
  • anchoring portion 4512 is provided with a third conductive portion for delivering pulsed ablation energy to tissue.
  • the third conductive part may be an electrode member provided on the surface of the anchoring part 4512 , or part of the second skeleton in the anchoring part 4512 .
  • At least one of the first conductive part 4531, the second conductive part 4532, and the third conductive part is used to release pulse ablation energy to tissue; in some embodiments, the first conductive part 4531, the second conductive part 4532, and the third conductive part All parts are used to release pulse ablation energy; in some embodiments, the first conductive part 4531 and the third conductive part are used to release pulse ablation energy, that is, the first conductive part 4531 and the third conductive part are used to transmit opposite polarities. pulse ablation energy and used to form an ablation circuit.
  • the second conductive part 4532 is used to collect electrophysiological signals of the target tissue; in some embodiments, at least one of the first conductive part 4531, the second conductive part 4532 and the third conductive part is used to perform ablation and mapping in a time-sharing manner. .
  • Figure 49C is a modified implementation based on the forty-fifth embodiment in Figure 49A.
  • the difference between the ablation system 4500C provided by this embodiment and the ablation system 4500 in the forty-fifth embodiment is that the anchoring portion A third conductive part 4533C is provided on the surface of 4512C, and the third conductive part 4533C is specifically a wave electrode.
  • the wave peaks and wave troughs of the third conductive part 4533C are arranged corresponding to the three anchoring rods in the anchoring part 4512C.
  • An anchor thorn 4519C is provided on the surface of the anchoring part 4512C.
  • the anchor thorn 4519C is disposed on the distal side of the third conductive part 4533C to prevent the anchor thorn 4519C from generating sparks during the simultaneous discharge of the first conductive part 4531C and the third conductive part 4533C for ablation.
  • the ablation system 4500D provided in Figure 49D and Figure 49D is a modified implementation based on the ablation system 4500C in Figure 49C.
  • the difference between the ablation system 4500D in this embodiment and the ablation system 4500C is that the third conductive part
  • the peaks and troughs of 4533D are staggered with the three anchoring rods 4513D of the anchoring part 4512D.
  • the third conductive part 4533D can be connected to the coating 4590D through the crests and troughs, thereby preventing the peaks and troughs of the third conductive part 4533D from being connected to the coating.
  • a perforation is formed at the position 4590D, and the third conductive part 4533D and the anchor part 4512 are short-circuited to each other through the perforation, thereby improving the insulation performance between the third conductive part 4533D and the anchor part 4512D.
  • Figure 50 is a schematic structural diagram of an ablation system 4600 according to the forty-sixth embodiment of the present application.
  • the ablation system 4600 of this embodiment is similar to the ablation system 4200 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the first conductive part 4631 is provided on the sealing part 4611.
  • the ablation catheter 4623 has a spherical mesh structure, and the second conductive portion 4632 is provided in the circumferential edge area of the spherical mesh structure.
  • the spherical mesh structure is the same as the spherical mesh structure of the thirty-seventh embodiment corresponding to Figure 40, and will not be described again here.
  • the difference from the ablation system of the thirty-seventh embodiment is that the distal end of the ablation catheter 4623 of this embodiment passes through the axial channel of the support body 4610 and can be released on the distal side of the anchoring part.
  • the ablation catheter of the thirty-seventh embodiment is released proximal to the sealing portion.
  • Figure 51 is a schematic structural diagram of an ablation system 4700 according to the forty-seventh embodiment of the present application.
  • the ablation system 4700 of this embodiment is similar to the ablation system 1000 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 4723 is a balloon, which is similar in structure to the ablation catheter provided in the thirty-eighth embodiment corresponding to FIG. 41 .
  • the balloon After the interior of the balloon is filled with medium, it expands outside the mouth of the left atrial appendage.
  • the balloon is in a disc shape after being filled, and the second conductive part 4732 is provided on the outer peripheral edge of the filled balloon.
  • the first conductive part 4731 is provided on the sealing part 4711.
  • the distal end of the ablation catheter 4723 in this embodiment passes through the axial channel of the support body 4710 and can be released on the distal side of the anchoring part 4712.
  • the ablation catheter of the thirty-eighth embodiment is released proximal to the sealing portion.
  • Figure 52 is a schematic structural diagram of an ablation system 4800 according to the forty-eighth embodiment of the present application.
  • the ablation system 4800 of this embodiment is similar to the ablation system 4200 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the ablation catheter is different.
  • the ablation catheter 4823 is a ring body, which is similar in structure to the ablation catheter provided in the thirty-ninth embodiment corresponding to FIG. 42 .
  • the second conductive part 4832 is provided on the ring body, and the first conductive part 4831 is provided on the sealing part 4811.
  • the second conductive part 4832 includes a plurality of parts spaced apart along the axial direction of the ring body, such as a plurality of electrode members spaced apart in sequence along the axial direction of the ring body.
  • the second conductive part 4832 may be part or all of the ring body, and may be provided at intervals or continuously.
  • the distal end of the ablation catheter 4823 in this embodiment passes through the axial channel of the support body 4810 and can be released on the distal side of the anchoring portion 4812.
  • the ablation catheter of the thirty-ninth embodiment is released proximal to the sealing portion.
  • Figure 53 is a schematic structural diagram of an ablation system 4900 according to the forty-ninth embodiment of the present application.
  • the ablation system 4900 of this embodiment is similar to the ablation system 4200 of the forty-second embodiment corresponding to Figure 45.
  • the main difference between this embodiment and the forty-second embodiment is that the structure of the support body and the arrangement of the first conductive part are different.
  • the support body 4910 has a double disk structure.
  • the second conductive part 4932 is provided on the conveyor.
  • the second conductive part 4932 can move relative to the support body 4910 and is used to be released on the distal side of the support body 4910 .
  • the first conductive portion 4931 is disposed adjacent to the proximal end of the support body 4910 .
  • the support body 4910 includes a sealing portion 4911 and an anchoring portion 4912, which are connected through a connecting piece 4913 to achieve an insulating connection.
  • the sealing portion 4911 adopts a disc-shaped structure with a short axial length.
  • the anchoring portion 4912 is cup-shaped and has an open distal end.
  • the anchoring portion 4912 may be made by braiding wire or by cutting tubing.
  • the distal end of the metal wire of the anchoring portion 4912 is converged radially inwardly at the connecting member 4913.
  • the first conductive portion 4931 is provided on the outer peripheral surface of the anchoring portion 4912 .
  • the first conductive part 4931 is a ring electrode.
  • the ablation catheter 4923 of this embodiment has the same structure as the ablation catheter 4223 of the 42nd embodiment.
  • the ablation catheter 4923 also adopts an umbrella-shaped frame.
  • the ablation catheter 4923 includes a plurality of support rods 4924 arranged radially around its axis. , an electrode member is provided at the circumferential end of each support rod 4924, so that the second conductive portion 4932 is formed at the circumferential end of the umbrella frame body. Since the distal side of the anchoring portion 4912 is open, the ablation catheter 4923 can be released inside the anchoring portion 4912 .
  • Figure 54 is a schematic structural diagram of an ablation system 5000 according to the fiftieth embodiment of the present application.
  • the structure of the ablation system of this embodiment is similar to the ablation system 4900 of the forty-ninth embodiment corresponding to Figure 53.
  • the main difference between this embodiment and the forty-ninth embodiment is that the structure of the ablation catheter is different.
  • the second conductive part 5032 is provided on the conveyor, and the second conductive part 5032 can move relative to the support body 5010 for release inside the support body 5010 .
  • the anchoring portion 5012 of the support body 5010 is cup-shaped and has an open distal end.
  • the second conductive portion 5032 can be released in the anchoring portion 5012 .
  • Ablation catheter 5023 is a balloon. After the interior of the balloon is filled with medium, it expands outside the mouth of the left atrial appendage, and the balloon takes a disk-like shape after filling.
  • the support body 5010 includes a sealing portion 5011 and an anchoring portion 5012 that are connected.
  • the first conductive part 5031 is a circular electrode fixed on the outer peripheral wall of the anchoring part 5012.
  • the second conductive part 5032 is provided on the outer peripheral edge of the inflated balloon, and the balloon is recovered into the outer sheath 5022 after the ablation is completed. Since the distal side of the anchoring part 5012 is open, the balloon can be released inside the anchoring part 5012.
  • the distal end of the anchoring portion 5012 is open, for example, the anchoring portion 5012 is cylindrical or cup-shaped, and the corresponding ablation catheter 5023 can be released inside the anchoring portion 5012.
  • the ablation catheter 5023 may be released inside the corresponding anchoring part 5012.
  • the second conductive part 5032 may enlarge the radial size and contact the tissue by passing through the mesh of the anchoring part 5012, or may ablate the left atrial appendage tissue by contacting the blood without undergoing deformation to enlarge the radial size.
  • Figure 55 is a schematic structural diagram of an ablation system 5100 according to the fifty-first embodiment of the present application.
  • the support body 5110 has a double-disk structure, and the first conductive part 5131 and the second conductive part 5132 are both disposed on the support body 5110.
  • the support body 5110 includes a sealing part 5111 and an anchoring part 5112.
  • the sealing part 5111 includes a first frame 5113 and the anchoring part 5112 includes a second frame 5117.
  • the second frame 5117 of the anchoring part 5112 is made of metal wire braiding, and the braided second frame 5117 has an inner and outer double layer. Specifically, the metal wire spreads and extends from the proximal end to the distal end of the anchoring portion 5112 to form the inner layer of the second skeleton 5117, and then is folded and wound back from the distal end to the proximal end, and braided to form the outer layer of the second skeleton 5117.
  • the second conductive part is disposed on the second frame 5117 of the anchoring part 5112.
  • the second conductive part is disposed on the second frame 5117.
  • the second electrode member serves as the second conductive portion 5132.
  • the surface of the remaining portion not connected to the second electrode member is insulated, that is, the anchor portion 5112 may be configured to insulate only the surface of the portion of the second frame 5117 that is not connected to the second electrode member.
  • the second conductive part 5132 adopts a ring electrode, that is, the second electrode member is a ring electrode, and the ring electrode is fixed on the circumferential outer wall surface of the anchoring part 5112.
  • the anchoring part 5112 is configured so that the entire surface of the second frame 5117 is insulated, and the ring electrode is an additional electrode.
  • surface insulation of the second frame 5117 can be achieved by providing a coating on the second frame 5117 .
  • the portion of the second frame 5117 that corresponds to the second electrode member is the portion where the second frame 5117 contacts the second electrode member.
  • the portion of the second frame 5117 that does not correspond to the second electrode member is the second frame 5117 The part that is not in contact with the second electrode member.
  • the second electrode member may also be configured as a structure that bends and extends along the circumferential direction, such as a zigzag shape, a wavy shape, etc.
  • the first frame 5113 is a metal wire braided structure.
  • the sealing part 5111 includes a disk surface 5114 facing away from the anchoring part 5112, a disk bottom 5115 facing the anchoring part 5112, and a waist part 5116 connected between the disk surface 5114 and the disk bottom 5115.
  • the diameter of the disk surface 5114 is larger than the diameter of the disk bottom 5115, and the diameter of the disk surface 5114 is slightly larger than the inner diameter of the left atrial appendage.
  • the diameter of the disc bottom 5115 is approximately consistent with the inner diameter of the left atrial appendage.
  • the first electrode member is disposed at the waist 5116 of the sealing portion 5111 as the first conductive portion 5131 so as to fit into the mouth of the left atrial appendage.
  • the first conductive part 5131 on the sealing part 5111 is part of the first frame 5113
  • the second conductive part 5132 on the anchoring part 5112 is a third conductive part disposed on the second frame.
  • Figure 56 is a schematic structural diagram of an ablation system 5200 according to the fifty-second embodiment of the present application.
  • the structure of the support body 5210 of the ablation system 5200 of this embodiment is similar to the structure of the support body 5110 of the fifty-first embodiment corresponding to Figure 55. Please refer to the above description of the fifty-first embodiment for the same parts, which will not be repeated here. Again. The main difference between this embodiment and the fifty-first embodiment is that the second conductive part is disposed in a different position.
  • first conductive parts 5231 are provided on the support body 5210 at intervals along the axis, and are respectively provided on the sealing part 5211 and the anchoring part 5212.
  • the first conductive part 5231 provided on the sealing part 5211 is at least part of the first frame
  • the first conductive part 5231 on the anchoring part 5212 is a ring electrode fixed on the outer wall surface.
  • the second conductive part 5232 is provided on the conveyor 5220.
  • the transporter 5220 includes an ablation catheter, and the second conductive portion 5232 is provided in the ablation catheter.
  • the ablation catheter has a network disk structure, which is similar to the ablation catheter provided in the thirty-fifth embodiment corresponding to FIG. 38 .
  • the second conductive part 5232 can be the entire mesh disk, so that the entire woven mesh disk can serve as an electrode to transmit ablation energy to the tissue.
  • the distal end of the delivery catheter in this embodiment passes through the axial channel of the support body 5210 and can be released on the distal side of the anchoring portion 5212.
  • the anchoring portion may be insulated.
  • an insulating coating is provided on the second frame of the anchoring part, or an insulating sleeve is provided, or the anchoring part is made of insulating material.
  • Figure 57 is a schematic structural diagram of an ablation system 5300 according to the fifty-third embodiment of the present application.
  • the ablation system 5300 in this embodiment is used to ablate the pulmonary veins, atrium, left atrial appendage in the heart, or the tissue to be ablated outside the heart.
  • the support body is a radially telescopic and expandable skeleton.
  • the ablation system 5300 includes a support body 5310 located at a distal end and a transporter 5320 located at a proximal end.
  • the support body 5310 is connected to the distal end of the transporter 5320, and is used to transport the support body 5310 along the delivery path to the vicinity of the tissue to be ablated, release it, and achieve tissue ablation.
  • the support body 5310 can adjust the radial size through the conveyor 5320, thereby achieving radial contraction and expansion.
  • the specific delivery device 5320 includes an outer sheath tube 5322 and an inner sheath tube 5321.
  • the inner sheath tube 5321 is inserted into the inner cavity of the outer sheath tube 5322.
  • the proximal end of the support body 5310 is connected to the distal end of the outer sheath tube 5322, and the distal end of the support body 5310 is connected to the distal end of the inner sheath tube 5321.
  • the outer sheath tube 5322 and the inner sheath tube 5321 of the delivery device 5320 can be adjusted.
  • the support body adopts the support body 5310 with a variable diameter structure, that is, when the support body 5310 expands, it forms a large diameter end and a small diameter end.
  • the maximum radial size of the large diameter end is larger than the maximum radial size of the small diameter end, and the large diameter end is close to The near end is set, and the small diameter end is set close to the far end.
  • the axial length of the large diameter end is greater than the axial length of the small diameter end.
  • the support body 5310 forms a receiving portion 5330 at the connection between the large diameter end and the small diameter end.
  • the receiving portion 5330 is arranged adjacent to the axis of the supporting body 5310 relative to the first conductive portion 5331 and/or the second conductive portion 5332.
  • the receiving portion 5330 is arranged adjacent to the axis of the support body 5310 relative to the first conductive part 5331 and the second conductive part 5332, that is, a recessed area is formed on the support body 5310, outside the outer wall of the accommodation part 5330
  • a receiving space is formed for accommodating the tissue to be ablated, which facilitates the characteristic electric field line E to pass through the tissue located in the receiving space.
  • At least one characteristic electric field line E passing through the accommodating space is inclined relative to the axis of the support body 5310, so that the accommodating portion 5330 of the support body 5310 is convenient for accommodating more tissue and can reduce the characteristic electric field line E passing through the accommodating space. Difficulty of organization.
  • the first conductive part 5331 is provided on the distal side of the large diameter end, and the second conductive part 5332 is provided on the proximal side of the small diameter end.
  • the radial dimension of the first conductive part 5331 is larger than the radial dimension of the second conductive part 5332 , that is, the radial dimension of the conductive part forming an annular structure located on the proximal side is greater than the radial dimension of the annular structure formed by the conductive part located on the distal side, so that at least one characteristic electric field line E passing through the accommodation space is inclined relative to the axis of the support body 5310 , to facilitate the passage of characteristic electric field lines through the tissue in the containment space.
  • the support body 5310 can also adopt other variable diameter structures, such as the maximum radial dimensions of the proximal end and the distal end are equal, a receiving portion is formed between the proximal end and the distal end, and the radial dimension of the first conductive portion 5331
  • the radial size is not equal to that of the second conductive portion 5332, so that at least one characteristic electric field line E passing through the accommodating space is also inclined relative to the axis of the support body 5310, which facilitates the characteristic electric field line to pass through the tissue in the accommodating space.
  • the accommodating part 5330 is arranged adjacent to the axis of the support 5310 relative to the first conductive part 5331 and the second conductive part 5332.
  • the characteristic electric field line E passes through the accommodating space.
  • the electric field lines passing through the accommodating space are relatively dense.
  • the electric field The greater the strength, the easier it is for the tissue located in the accommodation space to be ablated; the first conductive part 5331 and the second conductive part 5332 are provided on opposite sides of the accommodation space, and the radial size of the first conductive part 5331 is larger than that of the second conductive part 5332
  • at least one characteristic electric field line E passing through the accommodation space is inclined relative to the axis of the support body 5310 .
  • the support body 5310 includes a plurality of support rods 5311 spaced apart circumferentially along the axis of the support body 5310.
  • the number of support rods 5311 may be 4, 6, 8 or more.
  • the distal ends of each support rod 5311 are connected together, and the proximal ends are connected together.
  • Each support rod 5311 includes a first arc segment 5312, a second arc segment 5313, and a third arc segment 5314 connected in sequence.
  • both the first arc segment 5312 and the third arc segment 5314 are bent in a direction away from the central axis of the skeleton, and the second arc segment 5313 is bent in a direction close to the central axis of the skeleton, so that the support body 5310 is in the third position.
  • the receiving portion 5330 is formed at the second arc segment 5313; the radial size of the first arc segment 5312 is larger than the radial size of the third arc segment 5314, and the axial size of the first arc segment 5312 is larger than the third arc segment 5314.
  • axial size In other embodiments, the axial dimension of the first arcuate segment 5312 is no greater than the axial dimension of the third arcuate segment 5314.
  • the first conductive part 5331 is disposed at the connection between the first arc segment 5312 and the second arc segment 5313, and the second conductive part 5332 is disposed at the connection between the second arc segment 5313 and the third arc segment 5314. That is, the first conductive part 5331 is located on the proximal side of the accommodating part 5330, and the second conductive part 5332 is located on the distal side of the accommodating part 5330.
  • the radial size of the first conductive part 5331 is larger than the radial size of the second conductive part 5332.
  • the transporter 5320 transports the support body 5310 to the target area, the accommodating part 5330 is abutted against the pulmonary vein or the mouth of the left atrial appendage, and the characteristic electric field line E can pass through the tissue.
  • each support rod 5311 is covered with two annular electrodes at different positions in the axial direction, so that two rings of electrodes spaced around the axial direction are formed on the support body 5310.
  • the first conductive part 5313 includes A plurality of electrodes spaced in one circle, and the second conductive portion includes a plurality of electrodes spaced in another circle around the axial direction.
  • the conductive portions on both sides of the accommodation portion 5330 are spaced apart in the axial direction.
  • the extension direction of the receiving portion 5330 may also be between the circumferential direction and the axial direction, or may be irregular.
  • the conductive parts on both sides are provided on opposite sides of the accommodating part 5330, so that the characteristic electric field line E passes through the area outside the support body 5310, and then easily passes through the tissue during the ablation process, forming transmural ablation.
  • the support body 5310 can also be replaced by a balloon, such as a balloon made by cutting or weaving technology, and the balloon can contract and expand in the radial direction.
  • the balloon is filled with media, and the radial size of the balloon is adjusted by controlling the volume of the internal media.
  • Figure 58 is a schematic structural diagram of an ablation system 5400 according to the fifty-fourth embodiment of the present application.
  • the first conductive part 5431 and the second conductive part 5432 are both disposed on the support body 5410, that is, the first conductive part 5431 and the second conductive part 5432 are disposed on the support body 5410 at intervals along the axial direction.
  • the support body 5410 has a structure with a large proximal end and a small distal end, that is, the radial size of the proximal end of the support body 5410 is larger than the radial size of the distal end.
  • the frame is provided with a receiving portion between the first conductive portion 5431 and the second conductive portion 5432 . It can be understood that for supports with different shapes and structures, the receiving portion and the corresponding receiving space on the outside are different. In this embodiment, the receiving portion is formed between the sealing portion 5411 and the anchoring portion 5412 .
  • the first conductive part 5431 is provided on the proximal side of the support body 5410, specifically the sealing part 5411, and the second conductive part 5432 is located on the distal side of the first conductive part 5431, specifically the anchoring part 5412, both of which are located on the proximal side of the support body 5410.
  • the position of the support body 5410 has different radial dimensions, and the radial dimension of the first conductive part 5431 is larger than the radial dimension of the second conductive part 5432.
  • the characteristic electric field line E between the first conductive part 5431 and the second conductive part 5432 easily passes through the area outside the receiving part of the support body 5410, and the support body 5410 between the two conductive parts It is used to stick to the tissue and facilitate the characteristic electric field lines to pass through the tissue during the ablation process.
  • the support body 5410 includes a connecting sealing portion 5411 and an anchoring portion 5412, and the anchoring portion 5412 is provided with anchor thorns 5413.
  • the anchor 5413 When the anchor 5413 is removed, it can be used as an ablation catheter to perform ablation operations on areas such as the pulmonary veins and left atrial appendage.
  • the portion of the first conductive portion 5431 Subcomponents can be used only for mapping and have no ablation effect. In some embodiments, some components in the first conductive part 5431 are used for mapping, and some components have an ablation function. In some embodiments, at least some components of the first conductive portion 5431 are used for both mapping and ablation.
  • some components in the second conductive part 5432 may be used only for mapping and have no ablation effect. In some embodiments, some components in the second conductive part 5432 are used for mapping, and some components have an ablation function. In some embodiments, at least some components of the second conductive portion 5432 are used for both mapping and ablation.
  • the support body 5410 includes a frame 5414.
  • the surface of the skeleton 5414 may be provided with barrier members (such as membranes) for blocking thrombus.
  • barrier members such as membranes
  • the number and location of the barrier members are not limited.
  • the barrier members are not shown in Figure 58 .
  • the frame 5414 includes a first frame 5415, a second frame 5416 and an insulating member 5417.
  • the first frame 5415 and the second frame 5416 are both made of conductive materials, and the first frame 5415 and the second frame 5416 are connected by an insulating member 5417.
  • the first skeleton 5415 and the second skeleton 5416 are respectively used to transmit ablation energy with different polarities to the target tissue area.
  • Both the first skeleton 5415 and the second skeleton 5416 can be made of metal materials or polymer materials with good biocompatibility.
  • the metal material can be made of nickel-titanium alloy, cobalt-chromium alloy, stainless steel and degradable metal materials, preferably super-elastic shape memory alloy nickel-titanium wire.
  • the insulating member 5417 is made of insulating material with good biocompatibility.
  • the first frame 5415 and the second frame 5416 are made by a weaving process.
  • one of the first frame 5415 and the second frame 5416 is formed by a weaving process, and the other one is formed by a cutting process.
  • the manufacturing process of the skeleton 5414 is as follows: using conductive pipes to cut the first skeleton 5415 and the second skeleton 5416 respectively, and the insulating member 5417 is connected to the first skeleton through one or more of fusion connection, plug connection and snap connection. Between 5415 and the second skeleton 5416.
  • the ablation member 5430 includes a first conductive part 5431 provided on the first frame 5415 and a second conductive part 5432 provided on the second frame 5416 .
  • the first conductive part 5431 is at least part of the first frame 5415
  • the second conductive part 5432 is at least part of the second frame 5416
  • the surface of the first frame 5415 other than the first conductive part 5431 is insulated.
  • the surface of the area other than the second conductive part 5432 on the second frame 5416 is insulated, that is, both the first frame 5415 and the second frame 5416 ablate the target tissue area through part of the support rod surface.
  • first frame 5415 and the second frame 5416 are both cut and formed with multiple meshes.
  • the insulating member 5417 is connected between the first frame 5415 and the second frame 5416 in the shape of a straight rod.
  • each support rod in the insulating member 5417 is in an arc shape, a zigzag shape, or an annular shape, or the insulating member 5417 occupies a larger size in the axial direction than in FIG. 58 .
  • the plurality of support rods in the insulating member 5417 are connected to each other to form a mesh, that is, the specific form of the insulating member 5417 is not limited.
  • at least one of the first skeleton 5415 and the second skeleton 5416 may be obtained by knitting.
  • the first conductive part 5431 and the second conductive part 5432 are both part of the frame 5414.
  • at least one of the first conductive part 5431 and the second conductive part 5432 is additionally provided on the frame.
  • the ablation electrode on 5414 (the first frame 5415 or the second frame 5416) can maintain an electrical connection with the corresponding frame, or be insulated from the frame and connected to an external ablation signal source through wires.
  • first frame 5415 and the second frame 5416 are spaced apart in the axial direction.
  • first frame 5415 and the second frame 5416 are spaced apart in the circumferential direction.
  • first frame 5415 is arranged within a first angle range in the circumferential direction of the support body 5410
  • the second frame 5416 is arranged on the support body.
  • the first frame 5415 and the second frame 5416 are connected through an insulating member 5417.
  • first frame 5415 and the second frame 5416 are spaced apart in the circumferential direction and the axial direction.
  • the sealing portion 5411 is used to cover the left atrial appendage opening, it is easier to cover the circumferential circle of the left atrial appendage opening. Therefore, the first conductive portion 5431 provided in the sealing portion 5411 is beneficial to forming a complete annular ablation area at the left atrial appendage mouth, improving ablation. Effect.
  • the first conductive part 5431 is provided in the circumferential edge area of the sealing part 5411.
  • the first conductive part 5431 can be disposed on at least one of the proximal edge, the edge of the middle section, and the distal edge of the sealing part 5411.
  • the first conductive part 5431 is preferably disposed on the sealing part 5411 to be close to the mouth of the left atrial appendage. Circle locale.
  • the circumferential edge area refers to the 20% area on the sealing portion 5411 that is the largest distance from the axis of the sealing portion 5411 . In some embodiments, the circumferential edge area refers to the 10% area on the sealing portion 5411 that is the largest distance from the axis of the sealing portion 5411 . In some embodiments, the circumferential edge area refers to the 5% area on the sealing portion 5411 that is the largest distance from the axis of the sealing portion 5411 . In some embodiments, the circumferential edge area refers to the 3% area on the sealing portion 5411 that is the largest distance from the axis of the sealing portion 5411 . It can be understood that the identification of specific edge areas can be set according to actual needs and is not limited here.
  • At least one of the first conductive part 5431 and the second conductive part 5432 is an ablation electrode. More ablation electrodes can be provided in the first conductive part 5431 and the second conductive part 5432, and different ablation electrodes are spaced apart from each other. There is no limit to the different ablation electrodes. self setting position.
  • FIG. 59 is a schematic structural diagram of an ablation system 5500 provided in the fifty-fifth embodiment of the present application.
  • the ablation system 5500 is specifically an ablation catheter, which can be used to ablate intracardiac tissue or tissue to be ablated outside the heart.
  • the ablation system 5500 includes a support body 5510 and a delivery device 5520.
  • the support body 5510 is connected to the distal end of the delivery device 5520.
  • the delivery device 5520 only shows the catheter portion connected to the support body 5510 in FIG. 59 .
  • the difference between the ablation system 5500 provided in this embodiment and the ablation system provided in FIG. 58 lies in the structure of the support body 5510, the first conductive part 5531 and the second conductive part 5532.
  • the support body 5510 provided in this embodiment is generally in the shape of a sphere, and the support body 5510 may be in the shape of a sphere, an ellipsoid, or a shape close to a sphere.
  • the support body 5510 includes a proximal part and a distal part, the proximal part is used to connect the conveyor 5520, and the distal part is arranged away from the conveyor 5520 relative to the proximal part.
  • the second conductive part 5532 is provided on the surface of the distal part of the support body 5510, and the first conductive part 5531 is provided on the surface of the proximal part of the support body 5510.
  • At least one of the first conductive part 5531 and the second conductive part 5532 can be implemented in the form of any one or more electrode members provided in other embodiments of the present application. It can be understood that the conductive part of the skeleton of the support body may also be used as at least one of the first conductive part 5531 and the second conductive part 5532.
  • the proximal portion of the support body 5510 is formed into a mesh structure through a weaving or cutting process, at least part of the mesh structure is made of conductive metal material, and at least part of the conductive mesh is used as the first conductive mesh. Department 5531.
  • the second conductive portion 5532 provided on the distal portion of the support body 5510 includes one or more electrode members, and the electrode members may be in the form of point electrodes, rod electrodes, arc electrodes, wave electrodes, etc.
  • the first conductive part 5531 and the second conductive part 5532 are used to form an ablation circuit and are used to transmit pulse signals with opposite polarities, and are insulated from each other.
  • the structure of the distal part of the support body 5510 is the same as the structure of the proximal part, and both have the same grid structure.
  • the proximal part of the support body 5510 is provided with a grid structure as shown in Figure 59
  • the distal part of the support body 5510 is provided with other forms of support structures, such as other grid structures with different densities and different grid shapes, or In the shape of a mesh basket.
  • the second conductive part 5532 and the support body 5510 are insulated from each other.
  • the proximal part and the distal part of the support body 5510 are insulated by parts connection.
  • the distal part of the support body 5510 is used to abut against the target tissue wall, and the second conductive part 5532 needs to abut against the target tissue wall and perform ablation.
  • the second conductive part 5532 is used to ablate the target tissue wall.
  • the adhesion condition of the second conductive part 5532 is better than that of the first conductive part 5531.
  • the expected ablation depth of the second conductive part 5532 is larger than that of the first conductive part 5531. Therefore, the discharge area of the second conductive part 5532 is smaller than that of the first conductive part 5531. , thereby achieving a greater average current density of the second conductive part 5532, thereby expanding the ablation range and ablation depth of the second conductive part 5532.
  • the first conductive part 5531 and the second conductive part 5532 in this embodiment can adopt the specific parameters in other aforementioned embodiments, which will not be described again here.
  • the specific form of the first conductive part and the second conductive part is to use a skeleton to conduct electricity, or additionally set point electrodes, rod electrodes, arc electrodes, ring electrodes, wave electrodes, etc.
  • first conductive part and the second conductive part can all use the electric field intensity, voltage, average current density, distance, area and other parameters provided by the embodiments of the present application, and both can use the first ablation zone and the second conductive part.
  • the support body can be provided with a receiving portion for accommodating tissue and is disposed between two conductive portions. At least one characteristic electric field line passes through the receiving space outside the receiving portion, and at least one characteristic electric field line passes through the receiving space.
  • the distal ends of the characteristic electric field lines are inclined toward the axis of the support body. Inclined toward the axis of the support means that at least one characteristic electric field line passing through the accommodation space is neither parallel nor perpendicular to the axis of the support.
  • at least one characteristic electric field line passing through the accommodation space is neither parallel nor perpendicular to the axis of the support.
  • the projection of a characteristic electric field line on the characteristic plane can form two angles with the axis of the support body. The sum of the two angles is 180 degrees, and the smaller angle is an acute angle.

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Abstract

本申请提供一种消融系统，所述消融系统包括支撑体以及消融件，至少部分所述消融件设置于所述支撑体，所述消融件包括第一导电部与第二导电部，所述第一导电部与所述第二导电部用于构成回路传输脉冲消融能量，且二者极性相反，所述第一导电部与所述第二导电部的平均电流密度不相等。

Description

消融系统
本申请要求于2022年07月28日提交中国专利局、申请号为202210900583.8、申请名称为“一种消融系统”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
本申请属于医疗器械技术领域，更具体地说，是涉及一种消融系统。
背景技术
心房颤动(简称房颤)是最常见的持续性心律失常，随着年龄的增长，房颤发生率不断增加，75岁以上人群可达10％。房颤时心房激动的频率达300～600次/分，心跳频率往往快而且不规则，有时候可达100～160次/分，不仅比正常人心跳快得多，而且绝对不整齐，心房失去有效的收缩功能。心房颤动通常增加了获得许多潜在致命并发症的风险，包括血栓栓塞性中风，扩张性心肌病和充血性心力衰竭，常见的房颤症状如心悸，胸痛，呼吸困难，疲劳和头晕也会影响生活质量。与正常人相比，患有房颤的人平均发病率增加了五倍，死亡率增加了两倍。
组织消融是通常用于治疗各种心律失常，其中包括心房颤动。为了治疗心律失常，可以利用消融导管进行消融使病灶处组织变性坏死，从而阻断异常电信号的传导，而达到根治房颤的目的。现有的消融导管大部分是基于热消融，如射频消融、激光消融、微波消融、热物质消融等。
然而，基于热消融原理的消融装置通过发热对组织进行消融，在消融的过程中对消融装置中消融电极贴壁性要求较高，在消融电极贴壁不良的情况下，消融成功率较低。
发明内容
本申请实施例的目的在于提供一种消融系统，包括支撑体以及消融件，至少部分所述消融件设置于所述支撑体，所述消融件包括第一导电部与第二导电部，所述第一导电部与所述第二导电部用于构成回路传输脉冲消融能量，且二者极性相反，所述第一导电部与所述第二导电部的平均电流密度不相等。
现有的消融系统中，用于传输脉冲能量的构成回路的两个导电部表面平均电流密度接近，当需要增大其中一个导电部平均电流密度，以增大该导电部的消融范围以及消融深度的情况下，一般会采用提高两个导电部整体消融能量的方式(比如提高脉冲电压的方式)以提高其中一导电部的平均电流密度。
然而，提高两个导电部整体消融能量的方式势必会引起两个导电部总电流升高，表面的平均电流密度同步升高，对患者机体刺激较大。
本申请提供的消融系统的有益效果在于：与现有技术相比，本申请消融系统，第一导电部与第二导电部的平均电流密度不相等，可以通过第一导电部，及第二导电部的相互配合，向目标组织传输极性不同的脉冲消融能量，对目标组织实现脉冲消融。
本申请消融系统采用脉冲消融的方式，利用脉冲电场使细胞膜发生不可逆电击穿(不可逆电穿孔)，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，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，从而可避免误伤肺静脉临近的组织。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目标组织细胞均会发生电穿孔，降低了消融时对消融件贴靠目标组织壁的贴靠压力的要求。因此即使消融器械在消融过程中没有完全地贴合目标组织壁，也不影响其消融效果。
本申请提供的消融系统中，第一导电部与第二导电部的平均电流密度不相等，即构成回路的至少两个不同导电部的表面平均电流密度不同，以便于在第一导电部与第二导电部中，预期消融深度与消融范围较大的，平均电流密度更大，进而可以根据消融系统的不同目标组织的差异，不同导电部设置的具体位置，以及预期消融深度与消融范围，将构成回路的两个导电部中的一个导电部的平均电流密度设置相对较大，另一个导电部的平均电路密度设置的相对较小，使得平均电流密度较大的导电部的获得相对较大的消融范围，较深的消融深度，从而改善消融效果，实现完整的电隔离，避免构成回路用于传输脉冲消融能量的一对导电部由于表面平均电流密度相同，消融范围大小以及消融深度相近，在不同导电部贴壁条件不同，目标组织中不同位置厚度也具有差异的情况下，导致部分目标组织能够实现消融透壁，部分目标组织的消融透壁难度较大，在采用提高整体消融能量以保证目标组织均能达到透壁消融的消融策略后，对患者机体刺 激较大的情况出现。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1为本申请第一实施方式提供的左心耳封堵消融装置的结构示意图；
图2为本申请第二实施方式提供的左心耳封堵消融装置的结构示意图；
图3为本申请第三实施方式提供的左心耳封堵消融装置的结构示意图；
图4为本申请第四实施方式提供的左心耳封堵消融装置的结构示意图；
图5为本申请第五实施方式提供的左心耳封堵消融装置的结构示意图；
图6A为本申请第六实施方式提供的左心耳封堵消融装置的结构示意图；
图6B为本申请第六实施方式提供的左心耳封堵消融装置设置覆膜的结构示意图；
图7为本申请第七实施方式提供的左心耳封堵消融装置的结构示意图；
图8为本申请第八实施方式提供的左心耳封堵消融装置的结构示意图；
图9为本申请第九实施方式提供的左心耳封堵消融装置的结构示意图；
图10为本申请第十实施方式提供的左心耳封堵消融装置的结构示意图；
图11为本申请第十一实施方式提供的左心耳封堵消融装置的结构示意图；
图12为本申请第十二实施方式提供的左心耳封堵消融装置的结构示意图；
图13为本申请第十三实施方式提供的左心耳封堵消融装置的结构示意图；
图14为本申请第十四实施方式提供的左心耳封堵消融装置的结构示意图；
图15A为本申请第十五实施方式提供的左心耳封堵消融装置的结构示意图；
图15B为图15A中的左心耳封堵消融装置的不显示覆膜的结构示意图；
图15C为基于本申请第十五实施方式的另一变更实施方式提供的左心耳封堵消融装置的结构示意图；
图15D为图15C中的左心耳封堵消融装置的不显示覆膜的结构示意图；
图16为第十五实施方式提供的消融件的消融区间隔分布示意图；
图17为第十五实施方式提供的消融件的消融区部分重叠分布示意图；
图18为本申请第十六实施方式提供的左心耳封堵消融装置的结构示意图；
图19为本申请第十七实施方式提供的左心耳封堵消融装置的结构示意图；
图20为本申请第十八实施方式提供的左心耳封堵消融装置的结构示意图；
图21为本申请第十九实施方式提供的左心耳封堵消融装置的结构示意图；
图22为本申请第二十实施方式提供的左心耳封堵消融装置的结构示意图；
图23A为本申请第二十一实施方式提供的左心耳封堵消融装置的结构示意图；
图23B为图23A中的左心耳封堵消融装置不显示覆膜后的结构示意图；
图24为本申请第二十二实施方式提供的左心耳封堵消融装置的结构示意图；
图25为本申请第二十三实施方式提供的左心耳封堵消融装置的结构示意图；
图26为本申请第二十四实施方式提供的左心耳封堵消融装置的结构示意图；
图27为本申请第二十五实施方式提供的左心耳封堵消融装置的结构示意图；
图28为本申请第二十六实施方式提供的左心耳封堵消融装置的结构示意图；
图29A为本申请第二十七实施方式提供的左心耳封堵消融装置的结构示意图；
图29B为基于本申请第二十七实施方式的变更实施方式提供的左心耳封堵消融装置的结构示意图；
图29C为图29B中的左心耳封堵消融装置不显示覆膜的结构示意图；
图30为本申请第二十八实施方式提供的左心耳封堵消融装置的结构示意图；
图31为本申请第二十九实施方式提供的左心耳封堵消融装置的结构示意图；
图32为本申请第三十实施方式提供的左心耳封堵消融装置的结构示意图；
图33为本申请第三十一实施方式提供的左心耳封堵消融装置的结构示意图；
图34为本申请第三十二实施方式提供的左心耳封堵消融装置的结构示意图；
图35为本申请第三十三实施方式提供的消融系统的结构示意图；
图36为图35所示消融系统的原理结构示意图；
图37为本申请第三十四实施方式提供的消融系统的结构示意图；
图38为本申请第三十五实施方式提供的消融系统的结构示意图；
图39为本申请第三十六实施方式提供的消融系统的结构示意图；
图40为本申请第三十七实施方式提供的消融系统的结构示意图；
图41为本申请第三十八实施方式提供的消融系统的结构示意图；
图42为本申请第三十九实施方式提供的消融系统的结构示意图；
图43为本申请第四十实施方式提供的消融系统的结构示意图；
图44为本申请第四十一实施方式提供的消融系统的结构示意图；
图45为本申请第四十二实施方式提供的消融系统的结构示意图；
图46为图45所示消融系统的原理结构示意图；
图47为本申请第四十三实施方式提供的消融系统的结构示意图；
图48为本申请第四十四实施方式提供的消融系统的结构示意图；
图49A为本申请第四十五实施方式提供的消融系统的结构示意图；
图49B为图49A中的锚定部不显示覆膜后的结构示意图；
图49C为基于第四十五实施方式的变更实施方式提供的消融系统的结构示意图；
图49D为基于图49C的变更实施方式提供的消融系统的结构示意图；
图49E为图49D中的锚定部不显示覆膜后的结构示意图；
图50为本申请第四十六实施方式提供的消融系统的结构示意图；
图51为本申请第四十七实施方式提供的消融系统的结构示意图；
图52为本申请第四十八实施方式提供的消融系统的结构示意图；
图53为本申请第四十九实施方式提供的消融系统的结构示意图；
图54为本申请第五十实施方式提供的消融系统的结构示意图；
图55为本申请第五十一实施方式提供的消融系统的结构示意图；
图56为本申请第五十二实施方式提供的消融系统的结构示意图；
图57为本申请第五十三实施方式提供的消融系统的结构示意图；
图58为本申请第五十四实施方式提供的消融系统的结构示意图；
图59为本申请第五十五实施方式提供的消融系统的结构示意图。
具体实施方式
为了使本申请所要解决的技术问题、技术方案及有益效果更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者间接在该另一个元件上。当一个元件被称为是“连接于”另一个元件，它可以是直接连接到另一个元件或间接连接至该另一个元件上。
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”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。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
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该特征。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。
定义释义：
左心耳口部：从左心房进入左心耳的位置。
近端和远端：在医疗器械技术领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为近端，将距离操作者较远的一端称为远端，并依据此原理定义医疗器械的任一部件的近端和远端。在不违背本申请技术原理的情况下，以下各个实施方式中的具体技术方案可以相互适用。
近侧和远侧：沿着生物体内输送医疗器械的通道，将植入人体或动物体内的医疗器械或其中部件的朝向操作者的一侧称为近侧，将远离操作者的一侧称为远侧在不违背本申请技术原理的情况下，以下各个实施方式中的具体技术方案可以相互适用。
轴向和径向：“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，并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。
绝缘处理：在某部件的表面形成绝缘层，从而使部件该部分绝缘。具体地，绝缘处理的方式有：在需进行绝缘处理的位置设置绝缘涂层材料，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覆膜，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。在一些实施方式中，可以在需要绝缘处理的部分进行上述至少一种绝缘处理的方案，也可以使用以上两种或者两种以上相同或者不同的绝缘处理方式的组合方案。
第一实施方式
本申请实施例提供的消融系统，采用经皮穿刺的方式，通过输送器将消融装置输送到目标组织，包括但不限于输送至心脏特定的位置对肺静脉，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、冠脉静脉窦口等位置)进行消融，达到电隔离的效果。可以理解，消融组织区域不限定位于心脏，也可以位于其他机体组织，在此不作限定。
本申请实施例提供的消融系统可以是左心耳封堵消融系统，也可以是其他用于封堵与消融组织的器械，或者是不用植入体内的消融导管，其仅用于对目标组织进行消融，即可以是只用于消融组织的消融系统。本申请实施例提供的消融系统包括支撑体、输送器及消融件。输送器的远端与支撑体连接，用于将支撑体输送至目标组织。
消融件至少部分设置于支撑体，消融件包括第一导电部和第二导电部，在一些实施方式中，第一导电部与第二导电部均设于支撑体上。在一些实施方式中，第一导电部与第二导电部中的一个设于支撑体上，相应地，未设置于支撑体上的导电部可以设置于输送器，或者相对于支撑体以及输送器独立设置，即未设置于支撑体的导电部并未设置于输送器，比如为设置于患者体表的体外导电部，比如设置于体外的金属板。
第一导电部与第二导电部均电连接外部脉冲消融源，第一导电部和第二导电部用于向目标组织传输极性不同的脉冲消融能量，以实现组织消融。
支撑体包括径向可收缩和扩张的骨架或者是球囊，骨架可通过编织或切割工艺制作并形成多个网孔，球囊内用于填充介质，以调节径向尺寸。以下以骨架结构为例进行说明。支撑体可以在骨架表面设置有覆膜，以达到阻挡血栓、绝缘、保持支撑体机械稳定性等功能。
请参阅图1，本实施方式提供的消融系统包括左心耳封堵消融装置100与输送器。左心耳封堵消融装置100用于对左心耳进行封堵以及电消融作用。左心耳封堵消融装置100包括支撑体以及设置于支撑体上的第一导电部。本实施方式中，支撑体可通过编织或切割工艺制作并形成多个网孔的骨架。第二导电部设置于左心耳封堵消融装置100的支撑体，或设置于输送器，或者第二导电部独立于支撑体以及输送器设置，即第二导电部设置于支撑体以及输送器之外，比如第二导电部为用于在消融过程中贴附于患者体表的体外导电部。在本实施方式中，第一导电部通过输送器电连接至外部脉冲消融仪。目标组织为心肌组织中的左心耳。
支撑体包括相互连接的密封部110以及锚定部120，密封部110用于封堵左心耳的开口，锚定部120用于固定于左心耳组织壁。密封部110以及锚定部120均为径向可伸缩的可膨胀结构，密封部110以及锚定部120中的任意一个部分可以采用编织工艺或切割工艺制造。本实施方式中，密封部110设于锚定部120的近侧，在一些实施方式中，锚定部设于密封部的周向边缘。
具体地，密封部110包括第一骨架111，锚定部包括第二骨架121，第一骨架111与第二骨架121相互连接；密封部110设置有用于传输消融能量的消融件，具体为消融件中的第一导电部150。
本实施方式中的左心耳封堵消融装置100为单盘结构，即左心耳封堵消融装置100中的密封部110与锚定部120位于同一盘面中，密封部110与锚定部120的周向边缘区域的骨架，用于贴靠左心耳组织。
密封部110设置于锚定部120的近侧，密封部110的近端面用于释放在左心耳口部，第一骨架111周向边缘区域用于贴靠左心耳口部以及左心耳内腔组织壁，特别是第一骨架111中径向尺寸最大的部分用于贴靠左心耳内腔组织壁。可选地，左心耳封堵消融装置100内侧或外侧设置有用于阻挡血栓流出的至少一层覆膜，即支撑体包括设置于骨架外表面积/或内表面的至少一层覆膜，以阻挡左心耳内部的血栓流出至左心房。锚定部120用于释放于左心耳内腔中，锚定部120中第二骨架121周向侧壁用于对左心耳内壁产生 径向支撑力并固定于左心耳内腔中。可选地，如图1所示，第二骨架包括其表面设置有若干锚刺129，锚刺129相对于骨架向周向辐射翘起，使得锚定部120释放后，锚刺129能够结合在左心耳内腔组织中，提高锚定部120的锚定能力。
如图1所示，锚定部120为远端开口结构，或称左心耳封堵消融装置100为杯状结构。
密封部110中设置有用于传输消融能量的第一导电部150。在一些实施方式中，第一导电部150的至少部分能够用于采集组织生理信号。
在本实施方式中，第一骨架111中的至少部分作为第一导电部150，更具体地，第一骨架111中的全部作为第一导电部150，第一导电部150用于传输消融能量，在一些实施方式中，第一导电部150还能用于采集组织生理信号，比如心脏电生理信号，从而实现消融前与消融后的信号标测。
左心耳口部组织相对于左心耳内腔组织，表面平滑形状规则，便于密封部110贴靠，密封部110中的全部第一骨架作为第一导电部，对左心耳口部的组织进行消融，有利于提高第一导电部150的贴壁性能，便于对左心耳口部组织进行消融。
在一些实施方式中，第一骨架111中的部分作为第一导电部150。具体地，第一骨架111包括边缘区域与中心区域，中心区域相较于边缘区域距离密封部110的中心轴线较近，中心轴线穿过中心区域，密封部110中径向尺寸最大部分位于周向边缘区域中，第一导电部150设置在密封部110的周向边缘区域，以便于第一导电部150能够与左心耳组织贴靠或者距离较近。进一步地，在一些实施方式中，第一骨架111上径向尺寸最大的区域设置有第一导电部150。
在第一骨架111的边缘区域中设置第一导电部150，或者进一步地在第一骨架111上径向尺寸最大的区域设置有第一导电部150，第一导电部150并未设置于第一骨架111的中心区域，从而将消融能量释放的面积减小，将消融能量集中在放电面积较小的第一导电部150的位置，有利于提高消融深度。
具体地，密封部110由导电材料制成，可以采用生物相容性较好的超弹性金属材料制成，比如不锈钢，镍钛合金，钴铬合金等材料。由于本实施方式中，左心耳封堵消融装置100为一体结构。图1中的左心耳封堵消融装置100采用镍钛合金管激光切割而成，可以理解的是，左心耳封堵消融装置100还可以采用生物相容性较好的其他金属材料制作，或者采用切割工艺以外的其他工艺制作而成，比如编织工艺制成。
本实施方式中，锚定部120中的第二骨架121表面进行绝缘处理，绝缘处理的具体方式请参考前文说明。在本实施方式中，密封部110设置有用于对组织进行消融的第一导电部150，即左心耳封堵消融装置100可以利用第一导电部150对组织进行消融。
如图1所示，左心耳封堵消融装置100包括设置于第一骨架111的第一导电连接件130，第一导电连接件130用于电连接在第一导电部150与外部消融能量源之间，外部消融信号源可以为脉冲消融仪，脉冲消融仪用于输出脉冲消融电能，以供左心耳封堵消融装置100进行消融操作。
采用脉冲消融的方式，利用脉冲电场使细胞膜发生不可逆电击穿(不可逆电穿孔)，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。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，从而可避免误伤肺静脉临近的组织。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目标组织细胞均会发生电穿孔，降低了消融时对消融件贴靠目标组织壁的贴靠压力的要求。因此即使消融器械在消融过程中没有完全地贴合目标组织内壁，也不影响其消融效果。
第一导电连接件130设置于密封部110的近端，优选采用导电材料制成从而传输电能，比如可以采用不锈钢，镍钛合金，钴铬合金等材料。优选地，第一骨架111的近端收束于第一导电连接件130，第一导电连接件130还用于连接输送器，输送器的远端机械连接第一导电连接件130，并且实现与第一导电连接件130的电连接，输送器的近端用于与外部消融能量源之间保持电连接。
在一些实施方式中，可以在左心耳封堵消融装置100以外设置有用于与第一导电部150配合使用的第二导电部，第二导电部用于传输消融能量，在一些实施方式中，第二导电部至少部分能够用于采集组织生理信号。第一导电部与第二导电部电隔离，第一导电部和第二导电部可以用于向左心耳组织传输极性不同的脉冲消融能量，以实现组织消融。第一导电部和第二导电部两者的极性不同，在消融过程中呈一种极性的导电部为第一导电部，呈另一种极性的导电部为第二导电部，第一导电部设置在支撑体上。
该第二导电部可以设置于输送器上，如设于输送器中用于连接第一导电连接件130的导管上，也可以设置于输送器中的活动部件(比如消融导管)上，该活动部件可以相对于左心耳封堵消融装置100发生相对移动，活动部件用于从输送器的远端释放出来，第一导电部150与第二导电部之间形成用于对左心耳组 织进行消融的消融电场。第二导电部可以释放在左心耳封堵消融装置100的近侧，内腔或远侧。在一些实施方式中，第二导电部与左心耳封堵消融装置100和输送器独立设置，左心耳封堵消融装置100中的第一导电部150与设置于左心耳封堵消融装置100以及输送器以外的第二导电部配合使用，比如第二导电部为在消融过程中贴附于患者体表的第二导电部。第二导电部可以通过输送器或者是其他电缆连接至外部脉冲消融仪。
在一些实施方式中，在密封部110设置第一骨架111作为第一导电部150的基础上，左心耳封堵消融装置100在锚定部120设置有第二导电部，该第二导电部可以是锚定部120的部分或全部第二骨架，第一导电部150与第二导电部之间绝缘连接。
更具体地，在图1所示的单盘式左心耳封堵消融装置100中，第一骨架111中的至少部分作为第一导电部150，第二骨架121中的至少部分作为第二导电部，第一骨架111与第二骨架121之间绝缘连接，比如第一骨架111与第二骨架121的连接处采用绝缘材料连接，比如采用绝缘胶粘接连接，采用绝缘连接件进行连接，或者第一骨架111的远端及/或第二骨架121的近端采用绝缘材料制造。
在锚定部120设置有第二导电部的实施方式中，左心耳封堵消融装置100还设置有第二导电连接件，第二导电连接件用于与第二导电部电连接，第一导电连接件130与第二导电连接件电隔离，以传输极性不同的消融电能。具体地，第一导电连接件130与第二导电连接件之间绝缘连接，比如采用绝缘材料设置于两者之间。第二导电连接件与第二导电部之间可以采用第二导线实现电连接。
在锚定部120设置有第二导电部，但左心耳封堵消融装置100未设置第二导电连接件的实施方式中，第二导电部通过第二导线电连接至输送器，消融结束后，第二导线与输送器脱离，或者第二导线与第二导电部脱离，或者切断第二导线。可以理解的是，第二导电部与输送器的连接方式，可以适用于第一导电部150与输送器的连接方式中，在这里不做赘述。
左心耳口部组织相对于左心耳内腔中的组织，表面平滑形状规则，便于密封部110贴靠，密封部110中的部分或全部第一骨架111作为第一导电部150，对左心耳口部的组织进行消融，有利于提高第一导电部150的贴壁性能，便于对左心耳口部组织进行消融。
进一步地，请再次参阅图1，第一骨架111中包括多根密封一杆112，每根密封一杆112在近端与远端之间延伸，多根密封一杆112的近端结合在第一导电连接件130，可以理解的是，多根密封一杆112的近端不限于结合在第一导电连接件130，还可以结合于其他的部件。多根密封一杆112以第一导电连接件130为中心向四周朝向不同方向延伸，多根密封一杆112的远端相互间隔，使得第一骨架111形成具有网孔的镂空结构。
第二骨架121从第一骨架111的多个间隔的密封一杆112端部延伸而成，第二骨架121包括锚定一杆122以及锚定二杆123。锚定一杆122连接在密封一杆112与锚定二杆123之间，每根密封一杆112的远端连接两根不同的锚定一杆122，连接同一密封一杆112的两根锚定一杆122延伸方向不同，相邻的两根密封一杆112连接的4根锚定一杆122中，连接不同的密封一杆112的相邻的两根锚定一杆122的中间段之间相互靠拢连接，并在相互连接的位置设置有锚刺129。连接同一根密封一杆112的2根锚定一杆122的远端相互连接，并连接一锚定二杆123的近端，锚定二杆123的远端向远端延伸，相邻的锚定二杆123相互间隔设置，即各锚定二杆123的远端未连接或靠拢在一起，从而形成锚定部120远端开口的结构，即第二骨架121的远端及左心耳封堵消融装置100远端为开口的结构。
多根锚定一杆122在锚定部120形成了多个网孔，便于提高锚定部120的径向变形能力，以及与组织之间的摩擦力。
锚刺129从近端向远端延伸，锚刺129的固定端与锚定一杆122连接，锚刺129的自由端相对于锚定一杆122沿径向向四周翘起，便于与左心耳内部组织结合在一起。
第二实施方式
请参阅图2，本实施方式的消融系统包括左心耳封堵消融装置200，用于对左心耳进行封堵与消融，左心耳封堵消融装置200包括设置于近端的密封部210以及设置于远端的锚定部220，密封部210与锚定部220相互连接。
左心耳封堵消融装置200与左心耳封堵消融装置100的主要区别在于，第二导电部260设置于左心耳封堵消融装置200的骨架，第二导电部260用于传输消融能量；第二导电部260设于锚定部220上；第一导电部250与第二导电部260两者形成电隔离，第一导电部250和第二导电部260用于向左心耳传输极性不同的脉冲消融能量。第一导电部250及/或第二导电部260中的至少部分能够用于采集组织生理信号。
具体地，第二导电部260为额外设置于锚定部220表面的至少一个电极件。第二导电部260由生物相 容性较好的导电材料制成，比如铂、铱、金、银等可用于介入治疗的医用金属。
本实施方式中，第二导电部260中电极件的数量为一个，具体电极件为圆环电极。
圆环电极为条状或丝状电极，比如电极丝或者电极片，沿着锚定部220周向延伸，环绕锚定部220至少一周。圆环电极呈环状，比如呈圆环状，椭圆环状，或者不规则环状，以便形成环形的消融带。
如图2所示，圆环电极设置于垂直于左心耳封堵消融装置200中心轴线的平面内，即圆环电极的各个部分位于左心耳封堵消融装置200上相同的轴向位置上。在其他的实施方式中，圆环电极设置于相对于左心耳封堵消融装置200的中心轴线倾斜的平面内。
如图2所示，第一导电部250设置于支撑体近侧部分的周向边缘区域，第二导电部260设置于支撑体远侧部分的周向边缘区域，第二导电部260与第一导电部250共同作用以对组织进行消融。
在一些实施方式中，第二骨架221整体表面需要进行绝缘处理，在一些实施方式中，第二骨架221中未与第二导电部260接触的部分进行绝缘处理，与第二导电部260接触的部分不需要进行绝缘处理。在一些实施方式中，第二骨架221中与第二导电部260接触的部分进行绝缘处理，未与第二导电部260接触的部分不需要进行绝缘处理，或选择性的进行绝缘处理。
两个导电部用于传输极性不同的脉冲消融能量时，两个导电部之间产生用于对目标组织进行消融的消融电场。每个导电部的消融区为，该导电部周围形成的电场强度大于目标组织阈值强度的区域，位于该消融区中的目标组织能够被消融。具体地，第一导电部250周围形成的电场强度大于目标组织阈值场强的区域为第一消融区，第二导电部260周围形成的电场强度大于目标组织阈值场强的区域为第二消融区。
左心耳封堵消融装置200用于对心肌组织中的左心耳进行消融，当用于对左心耳进行脉冲消融的电场强度低于心肌组织阈值场强时，消融电场不能对左心耳进行消融，左心耳无生理效应。当用于对左心耳进行脉冲消融的电场强度高于心肌组织阈值消融场强时，脉冲击穿细胞膜形成纳米级不可逆电穿孔，破坏细胞内环境稳态，从而导致左心耳细胞坏死或凋亡。
左心耳要达到完全电隔离时，组织消融需要完全透壁，即组织的内壁与外壁均发生不可逆电穿孔。在此电场强度下，脉冲消融能量作用在目标组织的细胞膜上，细胞形成不可逆电穿孔的孔隙，从而破坏细胞内外环境稳态，达到电隔离效果，进而保证位于目标组织两侧的左心耳与左心房之间不能传递电生理信号，达到治疗房颤的目的。
高透壁性要求覆盖左心耳内壁与外壁的电场强度需大于心肌阈值场强。一般地，左心耳壁厚一般为3mm。在一些实施方式中，在消融过程中，消融件在距离其表面3mm的位置处，其产生的电场强度大于心肌阈值场强。在一些实施方式中，其产生的电场强度设置为大于400V/cm，从而保证对于不同患者的左心耳组织能够实现透壁消融。
距离消融件越近的位置电场线越密集，电场强度越大，组织越容易被消融。覆盖左心耳外壁的电场强度为400V/cm以上的情况下，消融件表面形成的电场强度大于左心耳外壁的电场强度，大于心肌阈值400V/cm。
而作用在心肌组织细胞上电场强度的高低，与脉冲电压范围、消融件的放电面积以及导电部之间距离的大小有关系。
在第一消融部设置于支撑体，第二消融部设置于支撑体或输送器实施方式中，消融件(第一导电部与第二导电部)采用的脉冲电压范围为500V～4000V，第一导电部250的放电面积为15mm2～4700mm2，第二导电部260的放电面积为15mm2～4700mm2。导电部具有多个电极件时，放电面积的取值范围是指该导电部所有电极件放电面积的总和。第一导电部250和第二导电部260表面距离最近的两点之间的距离的取值范围为1mm～45mm。
第一导电部250和第二导电部260都设置在左心耳封堵消融装置200的骨架上，两个导电部传输脉极性不同的冲消融电能，第一导电部250和第二导电部260间隔地设置在左心耳封堵消融装置200骨架轴向上的不同位置，电压范围为500V～4000V。若电压过低，两个导电部之间产生的电场强度过低，消融区过小，无法透壁消融，则会达不到消融效果。若电压过高，则对左心耳封堵消融装置200以及输送器的绝缘性能要求较高，对于现有的绝缘工艺以及材料，很难达到耐压值的需求。并且，电压过高，特别是在左心耳封堵消融装置200以及输送器的绝缘性能不能满足需求的情况下，容易造成消融件与其他部件之间相互电性耦合，产生电火花、组织焦痂，甚至造成心脏穿孔导致心包积液等对人体有害的结果。
两导电部具体可采用点状、杆状、线状或片状等多种形式。不论采用哪一种形式，其中发挥关键作用的是两导电部之间的距离，以及每个导电部的放电面积。
在两导电部之间的电压差不变的情况下，两导电部之间的距离大小直接影响两电极之间形成的电场强 度。导电部放电面积的大小能够改变导电部周围的电流密度，进一步影响电场效果。
在电流一定时，若消融件的放电面积过大，则电流密度过小，导电部表面形成的电场强度过低，消融区深度较浅，左心耳外壁位置的电场强度难以达到心肌阈值强度，难以形成消融透壁，消融成功率较低。若放电面积过小，电流密度过高，导电部容易与其他部件之间电耦合，产生电火花，左心耳封堵消融装置200中的部件容易因过热而被熔化或发生燃烧，绝缘材料遭到损坏，且导电部贴壁性不能保证。
脉冲电压在500V～4000V的范围内，消融件的放电面积在15mm2～4700mm2范围内，两个导电部间的距离取值范围在1mm～45mm，有利于在左心耳外壁处形成的电场强度大于心肌阈值场强，比如在消融过程中，消融件在距离其表面3mm处产生的电场强度大于400V/cm，有利于消融区能够覆盖到左心耳外壁，从而在左心耳组织处形成透壁消融。
上述参数适用于导电部的各种形式，比如形成于骨架的至少一部分，或者是各种形式的电极。
第一导电部250与第二导电部260用于构成回路传输脉冲消融能量，且二者极性相反，优选地，第一导电部250与第二导电部260的平均电流密度不相等。比如第一导电部250的平均电流密度大于第二导电部260的平均电流密度，或者第一导电部250的平均电流密度小于第二导电部260的平均电流密度，从而便于第一导电部250与第二导电部260中预期消融深度与消融范围较大的一个，平均电流密度更大。
消融系统中，第一导电部250与第二导电部260的平均电流密度不相等，即构成回路的至少两个不同导电部的表面平均电流密度不同，第一导电部与第二导电部中，预期消融深度与消融范围较大的一个，平均电流密度更大，进而可以根据不同的目标组织的差异，不同导电部设置的具体位置，以及预期消融深度与消融范围，将构成回路的两个导电部中的一个导电部的平均电流密度设置相对较大，另一个导电部的平均电路密度设置的相对较小，使得平均电流密度较大的导电部的获得相对较大的消融范围，较深的消融深度，从而改善消融效果，实现完整的电隔离，避免构成回路用于传输脉冲消融能量的一对导电部由于表面平均电流密度相同，消融范围大小以及消融深度相近，在不同导电部贴壁条件不同，目标组织中不同位置深度也具有差异的情况下，导致部分目标组织能够实现消融透壁，部分目标组织的消融透壁难度较大，在采用提高消融能量以保证目标组织均能达到透壁消融的消融策略后，对患者机体刺激较大的情况出现。
本实施方式中，第一导电部250与第二导电部260在轴向上间隔设置，第一导电部250设置于第二导电部260的近侧。在其他实施方式中，第一导电部250与第二导电部260可以在周向上间隔设置，左心耳封堵消融系统200中，除了第一导电部250与第二导电部260之外，还可以设置其他的导电部，即左心耳封堵消融系统200中的导电部的具体数量不做限定。
在消融过程中，所述第二导电部表面的平均电流密度大于所述第一导电部表面的平均电流密度。
将构成回路的两个导电部中的设置于远侧的第二导电部电流密度设置较大，形成较大的消融范围，较深的消融深度，特别适用于心脏组织的消融，比如对心内组织消融，比如心内的口部消融(肺静脉，左心耳等组织的消融)，或者是心内的局灶消融。
在左心耳封堵消融系统200中，第一导电部250与第二导电部260均用于对目标组织进行消融，即在目标组织形成消融区，第二导电部260相对于第一导电部250贴壁条件较差。
消融系统中的不同导电部用于在消融过程中靠近目标组织的不同位置，而不同导电部贴靠组织的条件不一，有的导电部贴靠组织条件较好，比如能够贴紧目标组织，则其比较容易形成较大的消融范围，较深的消融深度；有的导电部贴靠条件较差，比如由于导电部设置的位置、目标组织的位置，以及不同患者结构的差异，造成消融过程中导电部悬空，距离目标组织较远，无法对目标组织进行消融或者消融范围以及深度较小，消融效果很差。
贴壁条件相对较差的导电部的预期消融深度较大，从而减小或避免贴壁条件不好对其消融深度的影响。将贴壁条件相对较差的导电部平均电流密度设置相对较大，使其能够形成较大的消融范围，较深的消融深度，有利于实现完整的电隔离，将贴壁条件较好的导电部设置平均电流密度相对较小，在贴壁条件较好的情况下，也能保证一定的消融深度，有利于保证两个导电部的消融深度以及较好的消融效果。
左心耳封堵消融装置200用于释放并封堵在左心耳口部，密封部210用于释放并密封在左心耳口部位置，锚定部220连接于密封部210的远侧，用于释放并固定于左心耳口部内侧，第二导电部260用于对左心耳口部内侧组织进行消融。
研究发现，左心耳口部组织相对于左心耳口部内侧组织表面光滑，形状规则。移行于左心耳窦道腔内的心脏梳状肌造成了左心耳内部结构的复杂性。左心耳内部肌束粗大并多呈羽毛状棕榈叶样分布，这点在左心耳上部及下部表面尤其明显，而位于左心耳肌束间的腔壁其余结构极为纤薄。
锚定部220固定于其周缘接触的至少部分梳状肌表面，第二导电部260设置于锚定部220的周缘用于 对左心耳口部内侧的组织进行消融，能够被释放并贴近梳状肌，但是难以靠近周缘全部梳状肌表面以及肌束之间的组织，通过提高第二导电部260表面的平均电流密度，从而有利于提高第二导电部260的消融深度与消融范围，有利于在第二导电部260周围的粗大肌束以及肌束之间的纤薄组织形成透壁消融。
第二导电部260的放电面积小于第一导电部250的放电面积，从而在不改变两导电部整体消融能量的情况下，提高第二导电部260表面的平均电流密度。
优选地，第一导电部250的放电面积为15mm2～4700mm2，第二导电部260的放电面积为15mm2～500mm2。
第一导电部250的导电部分表面积相对较大，第二导电部260的导电部分表面积相对较小。第一导电部面250积在上述范围内的情况下，可以保证第一导电部250能够选择多种实现方式，比如，多个离散的电极件，圆弧电极，点状电极，杆状电极，环绕支撑体外壁至少一圈延伸的电极等多种电极形式，或者第一导电部250为支撑体部分金属骨架的方案，支撑体可以为编织工艺或切割工艺制成。另外，在该范围内，能够保证第一导电部250的面积能够便于对目标组织进行消融，避免第一导电部250面积过小，电流密度过大，且能量过度集中于此处，形成电火花，另外，消融范围过小，消融区减小，在导电部数量受到限制的情况下，难以形成完整的消融带；也避免了第一导电部面积过大，造成第一导电部250平均电流密度过低，消融范围过小，消融深度过低的情况出现。
第二导电部260在上述范围内，避免由于面积过小，电流密度过大，形成电火花，且能量过度集中于此处，导致第一导电部250能量分布过小，无法透壁，消融区减小。第二导电部260采用上述范围可以明显改善第二导电部的消融深度，并保证两导电部的消融深度与消融范围。在一些实施方式中，第一导电部250的放电面积为15mm2～4700mm2，第二导电部260的放电面积为15mm2～300mm2。优选地，第一导电部250和第二导电部260间的距离可进一步限定为3mm～22mm，即第一导电部250和第二导电部260之间的最近距离为3mm～22mm，也即，第一导电部250和第二导电部260相互最接近的点之间的间距为3mm～22mm。在此范围内，能够便于两个导电部的消融区部分重叠，即第一消融区与第二消融区部分重叠。两个消融区至少部分区域具有重合的部分，从而使得第一消融区与第二消融区叠加后形成的消融区的尺寸更大。消融区部分重叠时，两个导电部的消融能量集中在一起，能对一个相对较大区段中的组织进行消融，便于在厚度不均匀的左心耳组织中形成透壁消融，并降低在骨架释放位置偏差对消融效果的影响。
本实施方式中，第一导电部250与第二导电部260在骨架的轴向上间隔设置，第一消融区与所述第二消融区形成于消融系统轴向上的不同位置。左心耳封堵消融装置200释放至左心耳口部后，密封部210以及锚定部220周向一圈可能具有与组织贴靠不紧密的位置，若一导电部设置于该位置上，并且第一消融区与第二消融区不重叠，或者完全重叠的情况下，左心耳位置的消融区的区域范围较小，则导电部对应的消融区覆盖到左心耳组织外壁的可能性会降低，在周向上容易形成消融间隙，即消融区不能在周向形成完整环形消融带的概率大大提高；在第一消融区与第二消融区至少部分重叠的情况下，第一消融区与第二消融区部分重叠形成一个覆盖区域较大的轴向长度较长的消融区，即两个消融区具有重叠的部分，两个消融区连续，则可通过部分重叠后覆盖区域范围较大的消融区覆盖至左心耳组织外壁，减小消融区不能在周向形成完整环形消融带的概率，增大了在左心耳形成环形透壁消融带的轴向长度，便于集中消融能量进行透壁消融，提高消融成功率。当两个消融电场部分重叠后，消融区周向上为外凸的形式，以便于在消融区重叠的位置进行透壁消融。可以理解的是，在第一导电部250与第二导电部260在骨架周向上间隔设置的情况下，或者第一导电部250与第二导电部260以任意位置关系间隔(比如第二导电部设置于支撑体，第二导电部设置于输送器，或者第二导电部独立于支撑体以及输送器设置，第一导电部与第二导电部的方向相互平行或不平行)设置的情况下，若第一消融区与第二消融区部分重叠，都是便于形成覆盖区域范围更大的消融区，便于形成透壁的环形消融带。
优选地，鉴于左心耳口部厚度均匀形状规则，部分重叠后的第一消融区以及第二消融区形成的覆盖区域范围较大的消融区，能够覆盖左心耳口部内壁以及外壁位置。
在一些实施方式中，脉冲电压范围、消融件的放电面积以及导电部之间距离超出上述限定范围时，比如左心耳封堵消融装置200可通过增大电压范围、减小两个导电部距离的方式，使得两个消融区部分重叠，进而实现透壁消融。
自然状态，为左心耳封堵消融装置200不受外力下的状态，即左心耳封堵消融装置200并未受到输送器相关部件的束缚的以及组织的束缚作用。
如图2所示，在自然状态下，第二导电部260的近端设置于第一导电部250远端的远侧。即第一导电部250的远端与第二导电部260的近端在轴向上错开，从而增大两个导电部之间的距离，避免两个导电部 在进行消融的过程中，贴靠目标组织壁的条件相近，当其中一个导电部贴靠组织壁条件较差(比如悬空)，由于两个导电部轴向上设置位置彼此比较靠近，从而导致另外一个导电部贴靠组织壁条件也不佳的情况出现，进而改善了两个导电部的贴壁条件，保证消融件的消融效果。
优选地，第一导电部250与第二导电部260表面距离最近的两点之间的距离的取值范围为3mm～18mm。在两个导电部之间的最短距离为3mm～18mm的情况下，能够保证两个导电部之间的间隔较大，消融过程中两个导电部的贴壁条件具有差异，在其中一个贴壁条件不佳的情况下，对另外一个导电部贴壁条件的影响较小，同时保证了两导电部之间的距离不至于过大，保证了消融件的形成的电场强度与消融效果。
需要说明的是，本实施方式提供的各种技术方案在不矛盾的情况下可以适用于第一实施方式以及其他各个实施方式中，在此不做赘述。
第三实施方式
请参阅图3，本实施方式的消融系统包括左心耳封堵消融装置300，用于对左心耳进行封堵与消融，左心耳封堵消融装置300包括设置于近端的密封部310以及设置于远端的锚定部320，密封部310与锚定部320相互连接。
本实施方式中提供的左心耳封堵消融装置300与第二实施方式提供的左心耳封堵消融装置200的主要区别在于，本实施方式中，第二导电部360设置于第二骨架321的近侧部分；第二实施方式中，第二导电部360设置于第二骨架321的远侧部分。
在一些实施方式中，第二骨架321整体表面需要进行绝缘处理，在一些实施方式中，第二骨架321中未与第二导电部360接触的部分进行绝缘处理，与第二导电部360接触的部分不需要进行绝缘处理。
第四实施方式
请参阅图4，本实施方式的消融系统包括左心耳封堵消融装置400，用于对左心耳进行封堵与消融，左心耳封堵消融装置400包括设置于近端的密封部410以及设置于远端的锚定部420，密封部410与锚定部420相互连接。
本实施方式中提供的左心耳封堵消融装置400与第一实施方式提供的左心耳封堵消融装置100的主要区别在于，设置于左心耳封堵消融装置400的第一导电部450包括间隔设置在密封部410表面的多个电极件，每个电极件为点状电极。每个点状电极设置于不同的密封一杆上，在其他的实施方式中，每个密封一杆上的点状电极的数量可根据需要设置，比如，至少一个密封一杆上并未设置点状电极，或者一个密封一杆上设置多个点状电极。
每个点状电极，呈点状，比如直线或曲线围成的颗粒状电极。每个点状电极的截面呈圆形、椭圆形、环形、矩形、梯形、其他多边形或不规则形状。
在一些实施方式中，第一导电部450中的多个点状电极用于传输相同的消融电能，在一些实施方式中，相邻的点状电极为用于传输参数不同的消融电能，比如极性不同的消融电能。在一些实施方式中，每个点状电极用于传输的消融电能根据需要进行设置，比如对多个点状电极进行分组，同一组中的点状电极用于传输参数相同的消融电能。
在一些实施方式中，第一导电部450与第一骨架411之间绝缘，相应地，第一骨架411表面进行绝缘处理，或者第一导电部450中的多个电极件接触第一骨架411的一侧表面绝缘。
第五实施方式
请参阅图5，本实施方式的消融系统包括左心耳封堵消融装置500，用于对左心耳进行封堵与消融，左心耳封堵消融装置500包括设置于近端的密封部510以及设置于远端的锚定部520，密封部510与锚定部520相互连接。
本实施方式中提供的左心耳封堵消融装置500与第四实施方式提供的左心耳封堵消融装置400的主要区别在于，设置于左心耳封堵消融装置500的第一导电部550中的多个电极件均为杆状电极。
具体地，每个杆状电极均呈杆状，或者说长条状，杆状电极的两端在近端与远端之间延伸。在一些实施方式中，杆状电极的两端在左心耳封堵消融装置500的周向上延伸。在一些实施方式中，杆状电极的延伸方向相对于左心耳封堵消融装置500的轴线倾斜设置。
在一些实施方式中，第一导电部550中的多个杆状电极用于传输相同的消融电能，在一些实施方式中，相邻的杆状电极为用于传输参数不同的消融电能，比如极性不同的消融电能。在一些实施方式中，每个杆状电极用于传输的消融电能根据需要进行设置，比如对多个杆状电极进行分组，同一组中的杆状电极用于传输相同的消融电能。
在一些实施方式中，第一导电部550与第一骨架511之间绝缘，相应地，第一骨架511表面进行绝缘 处理，或者第一导电部550中的多个电极件接触第一骨架511的一侧表面绝缘。
第六实施方式
请参阅图6A，本实施方式的消融系统包括左心耳封堵消融装置600，用于对左心耳进行封堵与消融，左心耳封堵消融装置600包括设置于近端的密封部610以及设置于远端的锚定部620，密封部610与锚定部620相互连接。
本实施方式中提供的左心耳封堵消融装置600与第五实施方式提供的左心耳封堵消融装置500的主要区别在于，设置于左心耳封堵消融装置600的第一导电部650中的多个电极件均为圆弧电极。
具体地，每个圆弧电极呈一段圆弧的形状沿左心耳封堵消融装置600周向延伸，圆弧电极占据的弧长小于360度，多个圆弧电极相互间隔地设置在第一骨架611周向表面上。
如图6A所示，多个圆弧电极围成一环状，便于形成环形消融带。圆弧电极的数量可以根据需要进行设置。
不同圆弧电极在左心耳封堵消融装置600的周向上占据的圆周角不重叠。在一些实施方式中，不同圆弧电极在左心耳封堵消融装置600的周向上占据的圆周角至少部分重叠。
如图6A所示，不同圆弧电极位于左心耳封堵消融装置600的相同轴向位置上。在其他的一些实施方式中，相邻圆弧电极位于不同的轴向位置上。
在一些实施方式中，第一导电部650中的多个圆弧电极用于传输相同的消融电能，在一些实施方式中，相邻的圆弧电极为用于传输参数不同的消融电能，比如极性不同的消融电能。在一些实施方式中，每个圆弧电极用于传输的消融电能根据需要进行设置，比如对多个圆弧电极进行分组，同一组中的杆状电极用于传输相同的消融电能。
在一些实施方式中，第一导电部650与第一骨架611之间绝缘，相应地，第一骨架611表面进行绝缘处理，或者第一导电部650中的多个电极件接触第一骨架611的一侧表面绝缘。
请参阅图6B，图6B为图6A所示的左心耳封堵消融装置600中支撑体表面设置覆膜690的结构示意图。本实施方式中，支撑体包括设置于骨架外表面的覆膜690，从而避免左心耳内的血栓通过支撑体的网格流入左心房。设置于支撑体近侧的密封部610用于封堵左心耳，覆膜690至少覆盖密封部610，可以理解的是，覆膜690的远端可以延伸至锚定部620表面。支撑体表面设置覆膜690，用于避免支撑体直接接触组织，增大了支撑体与组织的接触面积，从而减小支撑体的骨架以及金属材料对组织的刺激，有利于降低术后并发症的发生率。覆膜690还用于保持骨架结构的稳定性，避免骨架过度形变，提高了支撑体植入后锚固的稳定性。如图6B所示，覆膜690的远端并未延伸至锚刺的位置，锚刺可以顺利刺入左心耳壁，在一些实施方式中，覆膜690覆盖到锚刺，锚刺的自由端可以刺穿覆膜而显露于覆膜690的外侧表面，从而利于支撑体锚定。
在变更实施方式中，支撑体的外侧表面与内侧表面中的至少一侧表面设置有覆膜690。
覆膜690设置于第一导电部650与支撑体之间，本实施方式中，第一导电部650与支撑体均由导电的金属材料制成。优选地，覆膜690也是绝缘膜，用于实现第一导电部650与支撑体之间的绝缘，避免第一导电部650释放消融能量的过程中，第一导电部650与支撑体之间短路，即第一导电部650释放的消融能量传输至支撑体。为提高第一导电部650与支撑体之间的绝缘性能，第一导电部650与支撑体之间还可以增加采用至少一种其他的绝缘方式，比如在骨架表面镀设绝缘涂层，支撑体骨架表面套设绝缘套管，加厚覆膜，至少部分支撑体采用绝缘材料制成等方案。
在变更实施方式中，第一导电部650与支撑体之间的绝缘可以采用设置覆膜以外的本申请提及的其他方式实现。在不违背本发明精神的情况下，本实施方式提供的覆膜690可以适用于其他实施方式中，以实现阻流、绝缘、保持结构稳定性、减小对组织刺激等作用中的至少一个作用，在此不做赘述。
第七实施方式
请参阅图7，本实施方式的消融系统包括左心耳封堵消融装置700，用于对左心耳进行封堵与消融，左心耳封堵消融装置700包括设置于近端的密封部710以及设置于远端的锚定部720，密封部710与锚定部720相互连接。
本实施方式中提供的左心耳封堵消融装置700与第六实施方式提供的左心耳封堵消融装置600的主要区别在于，左心耳封堵消融装置700的第一导电部750中包括电极件的数量为一个，电极形式为圆环电极，具体圆环电极的说明请参考前述实施方式。
可以在左心耳封堵消融装置700中设置与第一导电部750相互配合使用的第二导电部，或者将第二导电部设置在输送器，或者第二导电部与左心耳封堵消融装置700和输送器独立设置，都是被允许的，具体 请参阅第一实施方式。
第八实施方式
请参阅图8，本实施方式的消融系统包括左心耳封堵消融装置800，用于对左心耳进行封堵与消融，左心耳封堵消融装置800包括设置于近端的密封部810以及设置于远端的锚定部820，密封部810与锚定部820相互连接。
本实施方式中提供的左心耳封堵消融装置800与第七实施方式提供的左心耳封堵消融装置700的主要区别在于，左心耳封堵消融装置800的锚定部820远端为封闭结构，并且第二导电部860设置于左心耳封堵消融装置800的骨架上，具体设置于锚定部820，第二导电部860为设置于锚定部820表面的电极件，电极件的形式为圆环电极。
本实施方式中，锚定部820的远端是封闭的，即锚定二杆823的远端结合在一起，以封闭锚定部820的远端。在一些实施方式中，锚定部820的远端还设置有用于收束锚定二杆823端部的连接件。
具体第二导电部860设置于锚定部820上的具体位置可以根据需要进行设置。
第一导电部850与第二导电部860之间形成的电场用于对左心耳口部组织进行消融。具体第一导电部850与第二导电部860的圆环电极说明请参考前述实施方式。本实施方式可以采用第六实施方式中的阻流以及绝缘方式，比如，采用覆膜实现阻流，并实现第一导电部850与密封部810之间的绝缘，以及第二导电部860与锚定部820之间的绝缘等作用。
第九实施方式
请参阅图9，本实施方式的消融系统包括左心耳封堵消融装置900，用于对左心耳进行封堵与消融，左心耳封堵消融装置900包括设置于近端的密封部910以及设置于远端的锚定部920，密封部910与锚定部920相互连接。
本实施方式中提供的左心耳封堵消融装置900与第八实施方式提供的左心耳封堵消融装置800的主要区别在于，设置于左心耳封堵消融装置900骨架的第一导电部950与第二导电部960为点状电极的形式，具体点状电极的说明请参考前述实施方式。第二导电部960相对于第二导电部860靠近支撑体的近端设置。
第十实施方式
请参阅图10，本实施方式的消融系统包括左心耳封堵消融装置1000，用于对左心耳进行封堵与消融，左心耳封堵消融装置1000包括设置于近端的密封部1010以及设置于远端的锚定部1020，密封部1010与锚定部1020相互连接。
本实施方式中提供的左心耳封堵消融装置1000与第八实施方式提供的左心耳封堵消融装置800的主要区别在于，设置于左心耳封堵消融装置1000中的第一导电部1050与第二导电部1060均设置于密封部1010。
在密封部1010上，第一导电部1050与第二导电部1060设置的轴向位置不同，第一导电部1050设置于第二导电部1060的远侧。第一导电部1050与第二导电部1060均为圆环电极的形式，具体圆环电极的说明请参阅前述实施方式。
由于第一导电部1050设置在密封部1010的边缘区域，较佳地，密封部1010的径向尺寸最大的位置设置有第一导电部1050，相应地，第二导电部1060可以根据需要设置于第一导电部1050的近侧或远侧。
第十一实施方式
请参阅图11，本实施方式的消融系统包括左心耳封堵消融装置1100，用于对左心耳进行封堵与消融，左心耳封堵消融装置1100包括设置于近端的密封部1110以及设置于远端的锚定部1120，密封部1110与锚定部1120相互连接。
本实施方式中提供的左心耳封堵消融装置1100与第十实施方式提供的左心耳封堵消融装置1000的主要区别在于，设置于左心耳封堵消融装置1100骨架上的第一导电部1150与第二导电部1160的均为点状电极的形式，具体点状电极的说明请参考前述实施方式。
第十二实施方式
请参阅图12，本实施方式的消融系统包括左心耳封堵消融装置1200，用于对左心耳进行封堵与消融，左心耳封堵消融装置1200包括设置于近端的密封部1210以及设置于远端的锚定部1220，密封部1210与锚定部1220相互连接。
本实施方式中提供的左心耳封堵消融装置1200与第七实施方式提供的左心耳封堵消融装置700的主要区别在于，左心耳封堵消融装置1200中的密封部1210以及锚定部1220的结构与第七实施方式不同。
具体地，左心耳封堵消融装置1200采用编织工艺制成。密封部1210为左心耳封堵消融装置1200的 近端部分，锚定部1220为左心耳封堵消融装置1200中的远端部分，锚定部1220包括主体1222以及可设置于主体1222的远端的加强圈1223，加强圈1223沿着主体周向设置。
加强圈1223固定在主体1222的外周表面，加强圈1223靠近主体1222的部分与主体1222连接。加强圈1223中沿径向远离主体1222的部分，沿着径向向远离左心耳封堵消融装置1200轴线的方向凸伸，即加强圈1223凸设在主体1222远端的外围。加强圈1223用于释放在左心耳内部，接触并抵顶左心耳组织，提高左心耳封堵消融装置1200的锚定性能。
加强圈1223为沿周向相互连接的多个环形支撑圈，多个环形支撑圈在周向上排列一圈。在一些实施方式中，每个环形支撑圈围绕形成完整的环形，在一些实施方式中，每个环形支撑圈为曲线结构，并未围成一完整的环形，相邻的环形支撑圈的端部连接得到加强圈1223。
密封部1210与主体1222可以采用一体编织制成，在一些实施方式中，左心耳封堵消融装置1200采用一体编织而成。
本实施方式中，第一导电部1250为设置于密封部1210表面的电极件，具体电极形式为圆环电极，关于圆环电极的说明如前述实施方式中所述。
如图12所示，在一些实施方式中，第二导电部1260设置于左心耳封堵消融装置1200。比如，第二导电部1260为至少部分第二骨架1221。在一些实施方式中，第二导电部1260为加强圈123中的至少部分骨架。第一导电部1250与第二导电部1260相互作用，便于在左心耳口部形成环形消融带。具体第二导电部1260的其他设置方式请参考第七与第一实施方式。
在一些实施方式中，加强圈1223设置于密封部1210，凸设于密封部1210周向一圈，用于封堵在左心耳口部。在这种实施方式中，第一导电部1250可为加强圈1223中的至少部分骨架，使得便于在左心耳口部形成环形消融带。
第十三实施方式
请参阅图13，本实施方式的消融系统包括左心耳封堵消融装置1300，用于对左心耳进行封堵与消融，左心耳封堵消融装置1300包括设置于近端的密封部1310以及设置于远端的锚定部1320，密封部1310与锚定部1320相互连接。
本实施方式中提供的左心耳封堵消融装置1300与第十二实施方式提供的左心耳封堵消融装置1200的主要区别在于，第二导电部1360为设置于锚定部1320表面的电极件，更具体地，电极件为圆环电极的形式，具体圆环电极的说明，请参考前述实施方式。
加强圈1323的径向上的一端与主体1322连接，加强圈1323的径向上的另外一端是自由端，相对于主体沿着的径向向外侧凸伸。第二导电部1360设置于加强圈1323的自由端。在一些实施方式中，第二导电部1360设置于加强圈径向尺寸最大的位置，以便于第二导电部1360接触组织。加强圈1323的多个环形支撑圈的中部连通为一通道，在一些实施方式中，第二导电部1360穿设于加强圈1323形成的通道中。
左心耳封堵消融装置1300包括容纳部1330。容纳部1330相对于第一导电部1350及/或第二导电部1360邻近支撑体的轴线设置，本实施方式中，容纳部1330相对于第一导电部1350及第二导电部1360邻近支撑体的轴线设置，使得容纳部1330的周向外壁的外侧形成有用于容纳左心耳组织的容纳空间。
第一导电部1350上的任意一点与第二导电部1360上的任意一点之间最短的连线为一条特征电场线E。特征电场线E呈直线形，起始于第一导电部1350与第二导电部1360中的一个，终止于第一导电部1350与第二导电部1360中的另一个。特征电场线E附近分布的电场强度，相对于电场中其他位置的电场线更为密集，电场强度更大，该位置的电场强度更容易大于目标组织阈值场强，因此，特征电场线E穿过的组织容易被消融，消融效果较佳。
如图13所示，第一导电部1350和第二导电部1360设于容纳空间相对的两侧，在消融过程中，至少一条特征电场线E穿过支撑体外侧的区域，即穿过骨架远离其轴线一侧的区域，具体为穿过骨架的容纳部1330外侧形成的容纳空间。这样便于特征电场线E穿过位于容纳空间的组织。
具体地，如图13所示，第一导电部1350与第二导电部1360之间的主体1322用于贴靠左心耳组织壁部分的径向尺寸从近端至远端(由密封部向锚定部的方向)逐渐减小，而第二导电部1360设置在加强圈1323径向尺寸最大的位置，第二导电部1360的径向尺寸大于第一导电部1350的径向尺寸，或者第二导电部1360的径向尺寸与第一导电部1350的径向尺寸相近。这样左心耳封堵消融装置1300的骨架在第一导电部1350与第二导电部1360之间的部分为容纳部1330，容纳部1330外壁的外侧形成用于容纳左心耳组织的容纳空间。将左心耳封堵消融装置1300植入左心耳，容纳部1330的外壁至少部分用于贴靠左心耳组织。
左心耳封堵消融装置1300采用编织方式制成，第一导电部1350与第二导电部1360之间的容纳部1330沿左心耳封堵消融装置1300周向环绕设置，第一导电部1350和第二导电部1360在轴向上间隔设置，从而便于左心耳周向一圈组织容纳至容纳部1330中，第一导电部1350与第二导电部1360对容纳部1330中的组织进行消融，在左心耳形成连续的环形消融带。
可以理解地，容纳部1330的形成不限于采用本申请中多个实施方式提供的左心耳封堵消融装置的骨架结构，也可以是在第一导电部和第二导电部的载体之间具有向左心耳封堵消融装置轴线方向凹陷的其它结构，使得第一导电部与第二导电部之间的载体形成上述容纳空间，即该用于容纳目标组织的容纳部，可以设置于支撑体以及输送器，或者形成于支撑体与输送器之间。
第十四实施方式
请参阅图14，本实施方式的消融系统包括左心耳封堵消融装置1400，用于对左心耳进行封堵与消融，左心耳封堵消融装置1400包括设置于近端的密封部1410以及设置于远端的锚定部1420，密封部1410与锚定部1420相互连接。
本实施方式中提供的左心耳封堵消融装置1400与第一实施方式提供的左心耳封堵消融装置100的主要区别在于，左心耳封堵消融装置1400为双盘式结构，密封部1410呈盘状，锚定部1420呈盘状，密封部1410与锚定部1420之间通过连接件1491绝缘连接。连接件1491中的至少部分可以采用绝缘材料制成，使密封部1410与锚定部1420之间实现绝缘连接。
具体地，密封部1410中的第一骨架1411由编织工艺制成，从图14的角度看，密封部1410的远端面呈锥形，可以理解的是，密封部1410的近端面呈平面状或者呈锥形或是其他形状。
锚定部1420中的第二骨架1421由激光切割管材得到。第二骨架1421包括依次连接的锚定一杆1422，锚定二杆1423，锚定三杆1424，以及锚定四杆1425。
锚定一杆1422的近端连接连接件1491，锚定一杆1422在近端与远端之间延伸，锚定一杆1422远离连接件1491的一端连接两个锚定二杆1423的端部，每个锚定二杆1423的一端与一对应锚定一杆1422连接，相邻的两个锚定二杆1423的另一端连接在一起，并与对应一锚定三杆1424连接，相邻的锚定二杆1423首尾相接形成锯齿状结构。锚定二杆1423用于形成锚定部1420的远端面，锚定三杆1424在近端与远端之间延伸，设置于锚定一杆1422的外围，用于贴靠左心耳内壁。锚定三杆1424的近端连接锚定四杆1425，锚定四杆1425的一端与锚定三杆1424连接，锚定四杆1425的另一端为自由端，自由端向轴线的方向延伸，并向远端延伸。
第一导电部1450设置于密封部1410，第一导电部1450为密封部1410中的第一骨架1411中的至少部分骨架，比如全部第一骨架1411或者是部分第一骨架1411。图14中第一导电部1450为密封部1410中的周向边缘区域，至少设置于密封部1410中的周向边缘区域中径向尺寸最大的位置，另外，第一导电部1450至少设置于密封部1410周向边缘区域中朝向锚定部1420的区域，其用于贴靠左心耳口部的位置。在一些实施方式中，第一导电部1450设置于密封部1410周向边缘区域中朝向锚定部1420的区域，以及密封部1410背向锚定部1420的至少部分区域(近端面的至少部分区域)。
可选地，锚定部1420可以采用至少部分第二骨架1421作为第二导电部1460，第一导电部1450与第二导电部1460之间形成的脉冲消融电场用于消融组织。
在脉冲消融电场中，电场线是由第一导电部1450指向第二导电部1460的，或者由第二导电部1460指向第一导电部1450，沿着电场线的方向，距离第一导电部1450或第二导电部1460越近的位置，电场线越密集，消融电场强度越大，越容易形成透壁的消融带。
由于左心耳口部的组织贴靠第一导电部1450，并且电场线指向锚定部1420上设置的第二导电部1460，或者从第二导电部1460指向第一导电部1450，因此，绝大部分电场线会穿过左心耳口部的组织，左心耳口部的组织处的电场线较密集，电场强度较高，容易形成透壁消融带，具有大于心肌损伤阈值场强的电场穿过左心耳口部组织，消融成功率较高。
另一方面，第一导电部1450上的任意一点与第二导电部1460上任意一点之间最短的连线，为第一导电部1450与第二导电部1460之间的一条特征电场线E，特征电场线E附近的区域电场强度相对电场中的其他位置的强度较高，是电场能量较为集中的区域。
由于图14中为骨架在未受到外力而膨胀的自然状态下的视图，密封部1410的径向尺寸大于左心耳口部，便于密封部1410朝向锚定部1420一侧表面中径向尺寸较大的边缘区域，贴靠在左心耳口部位置中靠近或者是朝向左心房的一侧组织上。左心耳口部组织夹设在密封部1410与锚定部1420之间。
如图14所示，密封部1410的远端面呈锥形，且径向尺寸从近端至远端逐渐减小，第一导电部1450 为第一骨架1411的至少边缘部分，左心耳封堵消融装置1400的骨架包括设置在第一导电部1450与第二导电部1460之间的容纳部1430，容纳部1430具体为第一骨架与第二骨架相互朝向并贴近的部分。容纳部1430外壁的外侧形成用于容纳左心耳组织的容纳空间。将左心耳封堵消融装置1400植入左心耳，容纳部1430的外壁至少部分用于贴靠左心耳组织。
优选地，第二导电部1460中至少一个部分相对于第一导电部1450距离支撑体的轴线更近，使得穿过容纳空间的至少一条特征电场线E远侧部分(靠近第二导电部1360的部分)向靠近支撑体轴线的方向倾斜，导电部均设置于支撑体的周缘，能减小特征电场线E在容纳空间中穿过组织的难度，便于穿过容纳空间的特征电场线E穿过较多的待消融组织，保证消融效果。
本实施方式中，密封部1410的径向尺寸大于锚定部1420的径向尺寸，第一导电部1450设置在密封部1410径向尺寸最大的位置，因此，第一导电部1450的径向尺寸大于第二导电部1460的径向尺寸，便于更多经过第一导电部1450的特征电场线E的远侧部分向左心耳封堵消融装置1400的轴线方向倾斜，从而更多经过第一导电部1450的特征电场线穿过收纳空间，穿过左心耳口部的深处组织，便于在左心耳口部组织的一定厚度范围内，形成的电场强度大于心肌的电场阈值，从而在左心耳口部形成透壁消融。
自然状态下，第一导电部1450与第二导电部1460径向尺寸差值在3-15mm之间。第一导电部1450与第二导电部1460用于贴近目标组织，第一导电部1450与第二导电部1460之间的径向尺寸差值在上述范围内的情况下，能够保证第一导电部1450与第二导电部1460之间的至少部分特征电场线的远侧向轴线方向倾斜，第一导电部1450与第二导电部1460在对开口形组织进行效果的过程中，便于特征电场线穿过较多的待消融组织，保证消融效果，避免两导电部之间径向尺寸差距过大，导致两导电部之间的距离过远，电场强度降低太多的问题出现。
定义，第一特征点，为第一导电部1450周缘径向尺寸最大处的点；第二特征点，为第二导电部1460周缘径向尺寸最大处的点；特征平面，为经过支撑体的轴线以及第一特征点的平面。
自然状态下，选定的第一特征点与至少一第二特征点之间的特征电场线中长度最短的一个，在特征平面上的投影，与所述支撑体轴线x之间夹角之间的角度s为0-70°。
第一特征点为第一导电部1450的周缘的径向尺寸最大处的一点，第一特征点可以是第一导电部1450周缘的径向尺寸最大处的多个点中的任意一点，选定的第一特征点为第一导电部的周缘的径向尺寸最大处的确定的一点，在第一导电部周缘径向尺寸最大处呈环形线状的实施方式中，选定的第一特征点可以是该环形线状中的任意一个点。第一特征点位于特征平面内。
第二特征点为所述第二导电部1460的周缘的径向尺寸最大处的一点，第二特征点可以是第二导电部1460周缘的径向尺寸最大处的多个点中的任意一点，在第二导电部周缘径向尺寸最大处呈环形线状的实施方式中，第二特征点可以是该环形线状中的任意一个点。第二特征点可以位于特征平面内或者特征平面外。
第二特征点的数量为至少一个，选定第一特征点与每个第二特征点之间的能够得到一条特征电场线，选定的第一特征点与多个第二特征点之间能够得到与二特征点一一对应的多条特征电场线。在这些特征电场线中，存在一个长度最短的经过选定的第一特征点的特征电场线，比如，这条最短的经过选定的第一特征点的特征电场线为图14中所示的特征电场线E。图14中所示的特征电场线E的起点为第二特征点，终点为选定的第一特征点。经过选定的第一特征点的最短的特征电场E是径向上距离支撑体轴线x最远的特征电场线，即这些特征电场线E形成于左心耳封堵消融装置1400的周缘，相对于其他特征电场线，更容易穿过支撑体外侧的容纳空间，代表了两个导电部向支撑体之外辐射电场的能力。
经过选定的第一特征点的长度最短的一条/多条特征电场线E，相对于其他经过选定的第一特征点的特征电场线E，其周围电场线分布相对更密集，消融能量相对更集中，可以认为经过第一特征点的长度最短的特征电场线对应的目标组织区域的消融效果较佳，起到主要的消融作用。
经过选定的第一特征点的最短的特征电场线E投影在特征平面上，与支撑体轴线x之间具有一定的倾斜的角度s。特征电场线E相对于轴线x倾斜，便于特征电场线E穿过较多的待消融组织，有利于保证消融成功率。在本实施方式中，特征平面经过轴线x以及第一特征点与第二特征点，在其他实施方式中，第二特征点可能不在特征平面中，该经过选定的第一特征点的最短的特征电场线需要向特征平面投影。这个倾斜的角度s，代表了第一导电部1450与第二导电部1460在两者间距较小的情况下，第二导电部1460相对于第一导电部1450的径向尺寸的收缩程度，优选地，该角度s为0°-70°，其控制了该角度不至于过大，保证了两导电部之间的距离不至于过大，保证了消融电场强度。
在图1所示的第一实施方式中，若第二导电部1460设置于密封部110的远侧，比如设置在锚定部1420、或者设置于输送器、或者与左心耳封堵消融装置100和输送器独立设置，第一导电部1450与第二导电部 1460附近的左心耳组织的消融效果较佳，特别是接触第一导电部1450与第二导电部的组织。在特征电场线穿过左心耳组织表面，或者穿过左心耳组织深处的位置的情况下，均会保证较大的消融厚度，能够保证消融透壁。由于左心耳口部组织厚度相对较为均匀，形状规则，便于在该处消融，透壁的难度较低。
以上技术方案可以应用于其他实施方式中，在其他的实施方式中不做赘述。
如图14所示，在一些实施方式中，在第二骨架1421上额外设置电极件作为第二导电部1460，或者，在左心耳封堵消融装置1400以外设置第二导电部，比如设置于左心耳封堵消融装置1400的输送器，或者与左心耳封堵消融装置1400和输送器独立设置。
如图14所示，第一导电部1450设于骨架的近侧部分，第二导电部1460设于第一导电部1450的远侧。两导电部在骨架的位置其径向尺寸可设置为不同或者相同。优选地，如图14所示，第一导电部1450的径向尺寸大于第二导电部1460的径向尺寸。在一些实施方式中，在第一骨架1411上径向尺寸最大的周向边缘区域设置有第一导电部1450，如在第一骨架1411近侧径向尺寸最大的周向边缘区域设置圆环电极，由于第一导电部1450的径向尺寸设置为大于第二导电部1460的径向尺寸，便于特征电场线E穿过口部组织。
第十五实施方式
请参阅图15A与图15B，本实施方式的消融系统包括左心耳封堵消融装置1500，用于对左心耳进行封堵与消融，左心耳封堵消融装置1500包括设置于近端的密封部1510以及设置于远端的锚定部1520，密封部1510与锚定部1520相互连接。
本实施方式中提供的左心耳封堵消融装置1500与第十四实施方式提供的左心耳封堵消融装置1400的主要区别在于，第二导电部1560设置于左心耳封堵消融装置1500，第二导电部1560为设置在锚定部1520表面的电极件。锚定部1520包括第二骨架1521以及设置于第二骨架1521外表面的覆膜1590，锚定部1520表面设置有覆膜1590，第二导电部1560设置于覆膜1590背离第二骨架1521的一侧表面上。该覆膜1590用于实现锚定部1520与第二导电部1560之间的绝缘。可以理解的是，第二骨架1521与第二导电部1560之间可以采用其他实施方式提供的其他绝缘方式，比如第二骨架1521与第二导电部1560中的至少一个设置绝缘涂层、套设绝缘套管等。在一些实施方式中，锚定部1520与第二导电部1560之间采用至少两种相同或不同的绝缘方式，比如在第二骨架1521与第二导电部1560之间设置有覆膜1590的基础上，锚定部1520的第二骨架1521表面设置有绝缘涂层，或者设置有绝缘套管。可以理解的是，覆膜1590还具有阻流的作用。
第二导电部1560可以设置为波浪电极。
具体的，波浪电极在周向以及轴向上延伸，形成预设的电极图案，比如图15A所示，波浪电极在左心耳封堵消融装置1500周向上延伸的同时，还在轴向上交替地向近端或远端延伸，从而在锚定部1520的侧壁上沿波浪形轨迹在周向上延伸，从而扩展了第二导电部1560在轴向上的占用空间，增大了消融范围，并且便于左心耳封堵消融装置1500的装载与释放。
在本实施方式中，第一导电部1550、第二导电部1560满足前述实施方式中提供的参数，比如在消融过程中，在距离第一导电部1550以及第二导电部1560在距离各自表面3mm的位置产生的电场强度大于400V/cm。在一些实施方式中，消融系统用于对于左心耳以外的心脏组织进行消融，比如肺静脉厚度一般为2mm，保证在消融过程中，距离消融件表面2mm的位置处，其产生的电场强度大于心肌阈值场强，比如大于400V/cm，从而便于实现透壁消融。
在消融件设置于支撑体及/或输送器的实施方式中，消融件(第一导电部1550、第二导电部1560)采用的脉冲电压范围为500V～4000V，第一导电部1550的放电面积为15mm2～4700mm2，第二导电部1560的放电面积为15mm2～4700mm2。在第二导电部1560表面的平均电流密度大于第一导电部1550的情况下，第二导电部1560的放电面积可以参考前述实施方式中提供的15mm2～500mm2，导电部具有多个电极件时，放电面积的取值范围是指该导电部所有放电面积(电极件或骨架)的总和。第一导电部1550和第二导电部1560表面距离最近的两点之间的距离的取值范围为1mm～45mm。优选地，第一导电部1550和第二导电部1560间的距离可进一步限定为3mm～22mm。在此范围内，能够便于两个导电部的消融区部分重叠。为避免两导电部之间贴壁条件相近，即要保证两导电部之间具有一定的间隔距离，两导电部表面距离最近的两点之间的距离的取值范围为3mm～18mm。
如图15B所示，第二导电部1560为波浪形电极，具有波峰与波谷，其中第二导电部1560的波峰为第二导电部1560远离密封部1510的顶点，第二导电部1560的波谷为第二导电部1560邻近密封部1510的顶点。本实施方式中，第二导电部1560的波峰与波谷对应锚定部1520的锚定三杆1524设置，第二导电部1560的波峰与波谷可以固定设置于覆膜1590，或者穿过覆膜1590，固定于锚定三杆1524，锚定三杆 1524可设置有用于固定连接锚定三杆1524的连接部(比如通孔)。
本实施方式中，锚刺1529穿过覆膜1590显露于覆膜1590外侧。锚刺1529设置于锚定三杆1524，具体每个锚定三杆1524上设置有一个锚刺1529。锚刺1529设置于第二导电部1560的近侧，该位置处的锚定三杆1524的径向尺寸较大，有利于保证锚定部1520的锚定性能。可以理解的是，在一些实施方式中，锚定三杆1524上设置锚刺1529与第二导电部1560的部位径向尺寸一致，或者，锚定三杆1524上设置锚刺1529部位的径向尺寸，相对于锚定三杆1524上设置第二导电部1560部位的径向尺寸较小。
请参阅图15C与图15D，在基于第十五实施方式的变更实施方式中，左心耳封堵消融装置1500C与左心耳封堵消融装置1500的区别主要在于，第二导电部1560C与锚定三杆1524C的相对位置不同，第二导电部1560C与锚刺1529C的相对位置不同。
具体地，在本实施方式中，第二导电部1560C的波峰以及波谷与锚定三杆1524C错开设置，即第二导电部1560C的波峰设置在相邻的两个锚定三杆1524C之间，第二导电部1560C的波谷也设置在相邻的两个锚定三杆1524C之间。第二导电部1560C可以通过其波峰、波谷、波峰与波谷之间的部分，固定于覆膜1590C，或者穿过覆膜1590C固定于锚定三杆1524C。较佳地，第二导电部1560C在波峰、波谷的位置固定于覆膜1590C，从而提高第二导电部1560C与锚定部1520C之间的绝缘性能。
如图15C与图15D所示，在本实施方式中，第二导电部1560C设置于锚刺1529C的近侧，进而在第一导电部1550C与第二导电部1560C之间形成消融电场时，锚刺1529C位置处的电场强度较小，避免锚刺1529C在消融电场的作用下向组织放电，提高左心耳封堵消融装置1500C的安全性。
下面以第十五实施方式中的消融件为例说明本申请中较佳实施方式中消融件对应的消融区分布情况。图16为十五实施方式提供的消融件的消融区间隔分布的电场示意图，图17为十五实施方式提供的消融件的消融区部分重叠分布的电场示意图。图16中第一导电部1550周围形成的电场强度大于心肌阈值强度的区域为第一消融区1551，第二导电部1560周围形成的电场强度大于心肌阈值强度的区域为第二消融区1561。图16与图17均为在脉冲频率范围为500Hz～3MHz的条件下，消融区对应电场强度大于等于400V/cm时的分布示意图。图16与图17中的消融件采用图15A对应的第十五实施方式中的消融件，消融件包括第一导电部1550与第二导电部1560，第一导电部1550为密封部1510的至少部分骨架，第二导电部1560为设置于锚定部1520的波浪形电极件。从图16中可以看出，两导电部间的消融区不相交叠加，而是各自形成一个等值曲面。图16对应的左心耳封堵消融装置封堵在左心耳口部进行消融时，两导电部形成的消融区并未重叠，两个消融区中间间隔的区域处其电场强度过低，会导致该处不能进行完全电隔离。在轴向上，第一消融区1551的尺寸相对于图17所示的两个消融区部分重叠后形成消融区(图17中虚线外部轮廓限定的区域)的尺寸较小，左心耳封堵消融装置植入左心耳口部位置时，由于密封部或锚定部释放角度与位置的原因，容易导致密封部与锚定部形成的消融区无法透壁。比如密封部相对于口部可能会有一定角度的偏斜，即密封部与左心耳口部一圈存在贴合不严密的位置，第一消融区1551可能覆盖到左心耳口部组织中(内壁与外壁之间)，并未完全覆盖到左心耳口部外壁，难以达到口部位置的透壁消融，进而没有良好的消融效果。或者锚定部释放于左心耳内部的角度过于偏斜，导致第二导电部1560的部分悬空，不能完全贴壁，消融效果较差。
采用图17所示的消融区部分重叠的方式设置消融件，消融区在轴向上的尺寸大于单独任意一个消融区的轴向尺寸，这样便于将两个消融区的能量集中起来对一个部位进行消融，提高待消融区域的消融成功率。也就是说，即使在装置植入至左心耳口部后，即使密封部1510或者锚定部1520的周向边缘区域存在部分位置贴靠性不佳的问题，由于消融件在轴向上具有尺寸较大的消融区，相对于两个分离的轴向尺寸较小的消融区，更容易在密封部1510的周围形成透壁消融。
采用消融区部分重叠的方式，在轴向上具有近端部分与远端部分，即使近端部分由于贴壁性不佳，其外缘难以覆盖到左心耳外壁，远端部分可能覆盖到左心耳外壁，从而降低由于密封部释放后的贴壁条件对消融效果的影响，提高消融的成功率。
在本实施方式中，第一导电部1550设置于密封部1510，第一消融区与第二消融区部分重叠后形成的消融区分布于左心耳口部位置以及靠近口部的左心耳内壁，以便对左心耳口部附近进行消融。左心耳口部组织相对于左心耳内部组织，表面平滑，形状规则，第一导电部1550比较容易贴壁，厚度相对均匀，第二导电部1560相较于第一导电部1550的平均电流密度较大，消融深度较大，从而第一导电部1550与第二导电部1560在口部附近均能得到较好的消融效果，消融区便于在口部附近形成连续的透壁消融。
由于左心耳壁厚一般在3mm，重叠的两个消融区的边界与导电部表面之间的距离较大，超过左心耳壁厚，因此可以实现透壁消融。
第十六实施方式
请参阅图18，本实施方式的消融系统为左心耳封堵消融装置1600，用于对左心耳进行封堵与消融，左心耳封堵消融装置1600包括设置于近端的密封部1610以及设置于远端的锚定部1620，密封部1610与锚定部1620相互连接。
本实施方式中提供的左心耳封堵消融装置1600与第十五实施方式提供的左心耳封堵消融装置1500的主要区别在于，第一导电部1650为设置于密封部1610表面的电极件，电极件的形式圆环电极，具体圆环电极的说明请参考前述实施方式。密封部1610可以设置有至少一覆膜，覆膜可以设置于密封部1610的外表面或内腔中。覆膜可以设置在第一导电部1650与第一骨架1611之间。
第十七实施方式
请参阅图19，本实施方式的消融系统为左心耳封堵消融装置1700，用于对左心耳进行封堵与消融，左心耳封堵消融装置1700包括设置于近端的密封部1710以及设置于远端的锚定部1720，密封部1710与锚定部1720相互连接。
本实施方式中提供的左心耳封堵消融装置1700与第十四实施方式提供的左心耳封堵消融装置1400的主要区别在于，第一导电部1750为设置于密封部1710中第一骨架1711表面的电极件。电极件的具体形式为多个间隔设置的点状电极，具体点状电极的说明请参考前述实施方式。第二导电部可以设置于锚定部1720的第二骨架1721，或者并未设置于第二骨架1721，第二导电部可以设置于第二骨架1721以外的部件上。
第十八实施方式
请参阅图20，本实施方式的消融系统为左心耳封堵消融装置1800，用于对左心耳进行封堵与消融，左心耳封堵消融装置1800包括设置于近端的密封部1810以及设置于远端的锚定部1820，密封部1810与锚定部1820相互连接。
本实施方式中提供的左心耳封堵消融装置1800与第十七实施方式提供的左心耳封堵消融装置1700的主要区别在于，第二导电部1860设置于左心耳封堵消融装置1800，具体是设置于锚定部1820的第二骨架1821，第二导电部1860是位于锚定部1820表面上的多个间隔设置的点状电极，具体点状电极的说明请参考前述实施方式。
第十九实施方式
请参阅图21，本实施方式的消融系统为左心耳封堵消融装置1900，用于对左心耳进行封堵与消融，左心耳封堵消融装置1900包括设置于近端的密封部1910以及设置于远端的锚定部1920，密封部1910与锚定部1920相互连接。
本实施方式中提供的左心耳封堵消融装置1900与第十八实施方式提供的左心耳封堵消融装置1800的主要区别在于，锚定部1920表面设置的第二导电部1960为波浪电极，具体波浪形电极的结构形式参考上述实施方式。
第二十实施方式
请参阅图22，本实施方式的消融系统为左心耳封堵消融装置2000，用于对左心耳进行封堵与消融，左心耳封堵消融装置2000包括设置于近端的密封部2010以及设置于远端的锚定部2020，密封部2010与锚定部2020相互连接。
本实施方式中提供的左心耳封堵消融装置2000与第十六实施方式提供的左心耳封堵消融装置1600的主要区别在于，第二导电部2060为锚定部2020中第二骨架2021中的至少部分。
第二十一实施方式
请参阅图23A与图23B，本实施方式的消融系统包括左心耳封堵消融装置2100，用于对左心耳进行封堵与消融，左心耳封堵消融装置2100包括设置于近端的密封部2110以及设置于远端的锚定部2120，密封部2110与锚定部2120相互连接。本实施方式中的附图23B为左心耳封堵消融装置2100沿着轴线方向的截面图。
本实施方式中提供的左心耳封堵消融装置2100与第十五实施方式提供的左心耳封堵消融装置1500C的主要区别在于密封部2110与锚定部2120的具体结构。
具体地，本实施方式中，从图23A和图23B中的角度看，密封部2110沿轴线的截面呈梯形，第一骨架2111包括朝向锚定部2120的远端盘面，背离锚定部2120的近端盘面，以及连接在远端盘面与近端盘面之间的腰部2113。近端盘面与远端盘面大概呈平面状，腰部连接在近端盘面与远端盘面之间，腰部呈锥筒状。
第一导电部2150在本实施方式中为至少部分第一骨架2111，第一导电部2150至少设置密封部2110的径向尺寸较大的边缘区域中，比如在腰部2113，较佳的，设置于密封部2110周向上径向尺寸最大的部分。如图23A和图23B所示，还可将第一导电部2150设置于腰部2113以及近端盘面(图中虚线框中的部分)。在一些实施方式中，第一导电部2150设置于腰部2113，至少部分近端盘面以及至少部分远端盘面。第一骨架2111中不用于作为第一导电部2150的部分表面做绝缘处理，该绝缘处理的方式，可以采用设置覆膜，套设绝缘套管，镀设绝缘涂层，采用绝缘材料制作等方式中的至少一种方式。优选地，密封部2110的远端盘面的至少部分进行绝缘处理，从而避免第一导电部2150与锚定部2120之间相互短路，提高第一导电部2150与第二导电部2160之间的绝缘性能。
密封部2110近端的连接件2130可以用于与输送器机械连接并实现导电连接，从而实现第一导电部部2150通过连接件2130电连接至外部脉冲信号源。
第二导电部2160设置于锚定部2120，具体为波浪电极。第二骨架2121与第二导电部2160之间设置有覆膜2190，在变更实施方式中，第二骨架2121表面可以镀设绝缘涂层，或者套设绝缘套管以实现绝缘。在一些实施方式中，第二骨架2121与第二导电部2160之间采用至少两种相同或不同的绝缘方式进行绝缘。
密封部2110与锚定部2120之间连接有连接件2191，在一些实施方式中，连接件2191至少部分采用绝缘材料制成用于实现第一导电部2150与第二导电部2160之间的绝缘连接。优选地，连接件2191至少部分采用导电材料制成，用于电连接在第二导电部2160与输送器之间。
锚定部2120与锚定部1520之间的区别主要在于，锚定部2120中相邻的两个锚定四杆2125的远离锚定三杆2124的一端连接在一起，提高锚定部2120的力学性能，避免左心耳封堵消融装置2100在径向形变的过程锚定四杆2125相互钩挂，提高左心耳封堵消融装置2100的可靠性。
在利用本实施方式中提供的左心耳封堵消融装置2100进行消融的过程中，可以与标测导管配合使用，可以理解的是，在一些实施方式中，标测导管能够采集目标组织处的电生理信号，还具有向目标组织释放消融能量的作用。
第二十二实施方式
请参阅图24，本实施方式的消融系统包括左心耳封堵消融装置2200，用于对左心耳进行封堵与消融，左心耳封堵消融装置2200包括设置于近端的密封部2210以及设置于远端的锚定部2220，密封部2210与锚定部2220相互连接。
本实施方式中提供的左心耳封堵消融装置2200与第二十一实施方式提供的左心耳封堵消融装置2100的主要区别在于，第一导电部2250为设置在密封部2110的径向尺寸最大处的电极件，电极件的形式为圆环电极。第二导电部2260为设置于锚定部2220表面的电极件，电极件的具体形式为多个相互间隔设置的点状电极。在本实施方式中，每根锚定三杆2224上间隔设置有2个点状电极，在其他的一些实施方式中，每根锚定三杆2224上设置点状电极的数量可以根据需要设置，其中一些锚定三杆2224的表面可以不设置点状电极。可以理解的是，左心耳封堵消融装置2200可以根据需要设置覆膜。
第二十三实施方式
请参阅图25，本实施方式的消融系统包括左心耳封堵消融装置2300，用于对左心耳进行封堵与消融，左心耳封堵消融装置2300包括设置于近端的密封部2310以及设置于远端的锚定部2320，密封部2310与锚定部2320相互连接。
本实施方式中提供的左心耳封堵消融装置2300与第二十一实施方式提供的左心耳封堵消融装置2100的主要区别在于，密封部2310以及锚定部2320的具体结构与第二十一实施方式不同。
具体地，本实施方式中，密封部2310以及锚定部2320均由编织工艺制成。
密封部2310中的第一骨架2311为双层盘面结构，包括朝向锚定部2320的远端盘面，以及背离锚定部2320的近端盘面。近端盘面大概呈平面状，远端盘面呈部分球面状，近端盘面与远端盘面之间平缓过渡连接。第一导电部2350为第一骨架2311中的至少部分，设置于密封部2310中的径向尺寸较大的边缘区域中。
锚定部2320中第二骨架2321呈双层盘面结构，大概呈筒状，第二骨架2321侧壁的远侧径向尺寸小于近侧径向尺寸。第二导电部2360为设置于锚定部2320的电极件，电极件的形式为波浪电极。
第二十四实施方式
请参阅图26，本实施方式的消融系统包括左心耳封堵消融装置2400，用于对左心耳进行封堵与消融，左心耳封堵消融装置2400包括设置于近端的密封部2410以及设置于远端的锚定部2420，密封部2410与锚定部2420相互连接。
本实施方式中提供的左心耳封堵消融装置2400与第二十三实施方式提供的左心耳封堵消融装置2300的主要区别在于，第一导电部2450为设置于密封部2410中第一骨架2411表面的电极件，具体电极的形式为圆环电极，具体圆环电极的说明请参考上述实施方式。
第二十五实施方式
请参阅图27，本实施方式的消融系统包括左心耳封堵消融装置2500，用于对左心耳进行封堵与消融，左心耳封堵消融装置2500包括设置于近端的密封部2510以及设置于远端的锚定部2520，密封部2510与锚定部2520相互连接。
本实施方式中提供的左心耳封堵消融装置2500与第二十三实施方式提供的左心耳封堵消融装置2300的主要区别在于，锚定部2520的结构以及第二导电部2560的结构与第二十三实施方式不同。
具体地，锚定部2520为切割工艺制造。锚定部2520为双层盘结构，近端与远端封闭。第二骨架2521包括从远端至近端依次连接的锚定一杆2522，锚定二杆2523以及锚定三杆2524。
锚定一杆2522，锚定二杆2523以及锚定三杆2524均在近端与远端之间延伸，每根锚定一杆2522的近端连接两根不同的锚定二杆2523，连接同一锚定一杆2522的两根锚定二杆2523延伸方向不同，相邻的两根锚定一杆2522连接的4根锚定二杆2523中，连接不同的锚定一杆2522的相邻的两根锚定二杆2523的中间段之间相互靠拢连接。连接同一根锚定一杆2522的2根锚定二杆2523的近端相互连接，并连接锚定三杆2524的远端，多根锚定三杆2524的近端结合在一起，从而形成锚定部120两端封闭结构。
多根锚定二杆2523在锚定部2520形成了多个网孔，便于提高锚定部2520的径向变形能力，以及与组织之间的摩擦力。
第二导电部2560为设置于锚定部2520中第二骨架2521表面的电极件，具体电极的形式为圆环电极，具体圆环电极的说明请参考上述实施方式。
第二十六实施方式
请参阅图28，本实施方式的消融系统包括左心耳封堵消融装置2600，用于对左心耳进行封堵与消融，左心耳封堵消融装置2600包括设置于近端的密封部2610以及设置于远端的锚定部2620，密封部2610与锚定部2620相互连接。
本实施方式中提供的左心耳封堵消融装置2600与第二十五实施方式提供的左心耳封堵消融装置2500的主要区别在于，第二导电部2660的结构与第二十五实施方式不同。
本实施方式中，第二导电部2660为设置于锚定部2620中第二骨架2621表面的电极件，具体电极的形式为相互间隔设置于第二骨架2621表面的多个点状电极，具体点状电极的说明请参考上述实施方式。第二十七实施方式
请参阅图29A，本实施方式的消融系统包括左心耳封堵消融装置2700，用于对左心耳进行封堵与消融，左心耳封堵消融装置2700包括设置于近端的密封部2710以及设置于远端的锚定部2720，密封部2710与锚定部2720相互连接。
本实施方式中提供的左心耳封堵消融装置2700与第十五实施方式提供的左心耳封堵消融装置1500的主要区别在于，密封部2710的结构与以及第一导电部2750的结构第十五实施方式不同。
具体地，密封部2710中的第一骨架2711中包括多根密封一杆，每根密封一杆的两端均设置于密封部2710的中心轴线处。在垂直于中心轴线的平面上投影，即从远端向近端的方向看，或者从近端向远端的方向看，每根密封一杆围成大概环形的支撑环，本实施方式中该环形为扇形。在其他实施方式中，该环形可以为圆环形，椭圆环形，部分环形，或其他不规则环形等。多根密封一杆围成的多个支撑环在周向上排布得到第一骨架2711。
如图29A所示，相邻的支撑环在周向上相互搭接，在垂直于中心轴线的平面上投影，即从远端向近端的方向看，或者从近端向远端的方向看，相邻支撑环占据的圆心角有重叠的部分。在其他的实施方式中，相邻支撑环占据的圆心角不重叠，在一些实施方式中，相邻的支撑环之间还间隔圆心角设置。
如图29A所示，每根密封一杆的两端所在的轴向上的位置不同，即每根密封一杆的两端在轴向上错开。在其他实施方式中，每根密封一杆的两端所在的轴向上的位置相同。
第一导电部2750为密封部2710中第一骨架2711中的全部或部分骨架，具体第一导电部2750为第一骨架2711中径向尺寸较大的部分，包括径向尺寸最大位置的第一骨架2711，本实施方式中，图29A中两个虚线环之间的部分为密封部2710的周缘，第一导电部2750设置于图29A中两个虚线环之间。在一些实施方式中，第一导电部2750设置于第一骨架2711中径向尺寸最大的位置，即环绕在第一骨架2711周向边缘的一圈骨架。
第二导电部2760为设置于锚定部2720表面的波浪电极，第二导电部2760的波谷与波峰均对应锚定部2720的锚定三杆设置。
优选地，第二导电部2760与锚定部2720的第二骨架之间具有绝缘设计，比如第二导电部2760与锚定部2720的第二骨架之间设置有覆膜，第二骨架表面可以镀设有绝缘涂层，套设绝缘套管等。
锚定部2720表面设置有锚刺2729，锚刺2729设置于第二导电部2760近侧。
请参阅图29B至图29C，图29B至图29C中提供的左心耳封堵消融装置2700B为基于图29A中左心耳封堵消融装置2700的变更实施方式。左心耳封堵消融装置2700B中第二导电部2760B与锚定部2720B的第二骨架之间设置有覆膜2790B，可以理解的是，第二导电部2760B与锚定部2720B的第二骨架之间可以采用以下绝缘设计的至少一种，比如第二导电部2760B与锚定部2720B的第二骨架之间设置有覆膜2790B，第二骨架表面可以镀设有绝缘涂层、套设绝缘套管，或者锚定部2720B可以由绝缘材料制成等。
本实施方式与第二十七实施方式的区别在于，第二导电部2760B为设置于锚定部2720B表面的波浪电极，第二导电部2760B的波谷与波峰均与锚定部2720B的锚定三杆2724B错开设置，即第二导电部2760B的波峰与波谷均设置于相邻两个锚定三杆2724B之间的位置。第二导电部2760B可以通过波峰，波谷固定于覆膜2791；在一些实施方式中，第二导电部2760B可以通过波峰与波谷之间的部分固定于覆膜2791B，并可以进一步固定于锚定三杆2724B。
锚定部2720B表面设置有锚刺2129B，锚刺2129B设置于第二导电部2760B的远侧，从而有利于降低消融过程中锚刺2129B放电的风险。具体地，每根锚定三杆2724B外侧设置有至少一个锚刺2129B。
第二十八实施方式
请参阅图30，本实施方式的消融系统包括左心耳封堵消融装置2800，用于对左心耳进行封堵与消融，左心耳封堵消融装置2800包括设置于近端的密封部2810以及设置于远端的锚定部2820，密封部2810与锚定部2820相互连接。
本实施方式中提供的左心耳封堵消融装置2800与第二十七实施方式提供的左心耳封堵消融装置2700的主要区别在于，第一导电部2850的结构与第二十七实施方式不同。
本实施方式中，第一导电部2850为设置于密封部2810周向径向尺寸最大位置的电极件，电极件的形式为圆环电极，具体圆环电极的说明请见前述实施方式。
第二十九实施方式
请参阅图31，本实施方式的消融系统包括左心耳封堵消融装置2900，用于对左心耳进行封堵与消融，左心耳封堵消融装置2900包括设置于近端的密封部2910以及设置于远端的锚定部2920，密封部2910与锚定部2920相互连接。
本实施方式中提供的左心耳封堵消融装置2900与前述实施方式提供的左心耳封堵消融装置的主要区别在于，锚定部2920为双盘式结构。
具体地，密封部2910以及锚定部2920可以均由编织丝编织而成。
密封部2910呈圆柱形或锥形，径向尺寸大于左心耳开口。如图所示，第一导电部2950为圆环电极，设置在密封部2910径向尺寸最大处，还一些实施方式中，第一导电部2950还可设置边缘区域中的其他位置。
锚定部2920包括在轴向上间隔设置的锚定一部2922与锚定二部2923，锚定一部2922与锚定二部2923均由编织丝编织而成，呈圆柱形或锥形。锚定一部2922与锚定二部2923之间设置有连接件2924，在一些实施方式中，连接件2924具有柔性，及/或具有弹性。
第二导电部2960为设置于锚定一部2922径向尺寸较大处的电极件，具体电极件为圆环电极，具体圆环电极说明请参考前述实施方式。
在一些实施方式中，第二导电部2960可以设置于锚定二部2923，或者密封部2910的径向尺寸较大的位置，或者设置于连接件2924。
第三十实施方式
请参阅图32，本实施方式的消融系统为左心耳封堵消融装置3000，用于对左心耳进行封堵与消融，左心耳封堵消融装置3000包括设置于近端的密封部3010以及设置于远端的锚定部3020，密封部3010与锚定部3020相互连接。
本实施方式中提供的左心耳封堵消融装置3000与第二十九实施方式提供的左心耳封堵消融装置的主要区别在于，第一导电部3050以及第二导电部3060的结构。
本实施方式中，第一导电部3050为密封部3010中的至少部分第一骨架，优选为径向尺寸较大的部分， 优选地，包括径向尺寸最大的部分。
第二导电部3060为锚定部3020中的至少部分骨架，优选为锚定一部3022径向尺寸较大的部分，优选地，包括锚定一部3022径向尺寸最大的部分。第二导电部3060还可以设置于锚定二部3023，或者设置于密封部3010，或者设置于连接件3024。
第三十一实施方式
请参阅图33，本实施方式的消融系统为左心耳封堵消融装置3100，用于对左心耳进行封堵与消融，左心耳封堵消融装置3100包括设置于近端的密封部3110以及设置于远端的锚定部3120，密封部3110与锚定部3120相互连接。
本实施方式中提供的左心耳封堵消融装置3100与第三十实施方式提供的左心耳封堵消融装置的主要区别在于，密封部3110与锚定部3120的结构，以及第一导电部3150以及第二导电部3160的结构。
密封部3110与锚定部3120可以均由编织工艺制成。密封部3110为双层网盘状，密封部3110的直径大于左心耳口部的直径。
锚定部3120包括锚定一部3122以及锚定二部3123，锚定一部3122以及锚定二部3123可以为单层网盘或多层网盘状，锚定一部3122设置于锚定二部3123的近侧。
密封部3110与锚定一部3122之间连接有连接件3124与连接件3125。连接件3124与连接件3125在近端与远端之间延伸，连接件3124沿左心耳封堵消融装置3100的轴向设置，连接件3125的数量至少为一个，在周向上围绕连接件3124设置。
连接件3124可以为螺旋结构，连接件3124允许具有可变的长度，这使左心耳封堵消融装置3100能够用于具有不同形状以及不同尺寸的左心耳。连接件3124可弯曲，因此允许左心耳封堵消融装置3100具有不同角度以及不同方向，这也使左心耳封堵消融装置3100能够用于具有不同形状以及不同尺寸的左心耳。连接件3124具有基本上不变的或不变的横截面。
连接件3125包括基本上非弹性或完全非弹性的材料，使得连接件3125防止连接件3124延长超过预定长度。由于连接件3125防止连接件3124延长超过预定长度，因此连接件3125防止连接件3124在将左心耳封堵消融装置3100载入左心耳中或在左心耳中取出左心耳封堵消融装置3100期间过度拉伸。连接件3124周围可以设置两个连接件3125或更多个连接件3125。
第一导电部3150为密封部3110中的至少部分第一骨架，优选为径向尺寸较大的部分，优选地，包括径向尺寸最大的部分。
第二导电部3160为锚定二部3123中的至少部分第二骨架，优选为锚定二部3123径向尺寸较大的部分，优选地，包括锚定二部3123径向尺寸最大的部分。
在一些实施方式中，第二导电部3160为锚定一部3122中的至少部分第二骨架，或者设置于连接件3124及/或连接件3125。
连接件3124与连接件3125可以作为导电连接件用于传输电能。
第三十二实施方式
请参阅图34，本实施方式的消融系统为左心耳封堵消融装置3200，用于对左心耳进行封堵与消融，左心耳封堵消融装置3200包括设置于近端的密封部3210以及设置于远端的锚定部3220，密封部3210与锚定部3220相互连接。
本实施方式中提供的左心耳封堵消融装置3200与第三十一实施方式提供的左心耳封堵消融装置3100的主要区别在于，第二导电部3260的结构。
本实施方式中，第二导电部3260为锚定一部3222表面设置的电极件，电极件的形式为圆环电极。第二导电部3260优选设置于锚定一部3222径向尺寸较大的部分，优选地，设置于锚定一部3222径向尺寸最大的部分。在一些实施方式中，第二导电部3260为锚定二部3222表面设置的电极件，优选设置于锚定二部3223径向尺寸较大的部分。
第三十三实施方式
图35为第三十三实施方式提供的消融系统3300的结构示意图，图36为第三十三实施方式提供的消融系统3300植入至左心耳位置的结构示意图。结合参阅图35、图36，消融系统3300包括支撑体3310、输送器3320和消融件3330。支撑体3310用于植入至目标组织，如左心耳开口处等需要进行消融操作的位置。输送器3320用于将支撑体3310输送至目标组织，如左心耳开口处或其它目标组织，目标组织包括但不限于是心肌组织。消融件3330用于对目标组织壁进行电消融。消融件3330用于消融的组织可以与支撑体3310释放的组织位置不同。
支撑体3310采用单盘式结构，整体呈柱状。支撑体3310为通过编织和/或切割工艺制成的镂空网格结构。支撑体3310包括相连接的密封部3311和锚定部3312。支撑体3310释放至左心耳10后，密封部3311位于左心耳口部远侧。锚定部3312的远侧形成开口。
锚定部3312的外壁面上设有锚刺3313，锚刺3313用于在左心耳内壁上锚定。锚刺3313沿锚定部3312外壁面一周均匀设置多个，根据锚刺3313的结构可采用不同的设置方式。锚刺3313可以直接固定在锚定部3312上，具体可采用焊接的方式固定。锚刺3313也可以通过钢套与锚定部3312固定连接在一起。锚刺3313与锚定部3312也可以为一体结构，即锚刺3313由锚定部3312直接延伸形成。
消融件3330包括第一导电部3331和第二导电部3332。第一导电部3331和第二导电部3332用于向目标组织传输极性不同的脉冲消融能量，以实现组织消融。本实施例中，第一导电部3331设置于支撑体3310，第一导电部3331通过输送器3320电连接外部脉冲消融源，第二导电部3332设置于输送器3320，第二导电部3332能够相对于支撑体3310移动，用于释放于支撑体3310的近端。具体地，支撑体3310的侧壁呈弧形，支撑体3310径向尺寸最大的位置用于在径向上抵顶在左心耳内壁组织上，贴壁性较佳。在支撑体3310径向尺寸最大的位置设置有一第一导电部3331，这样便于第一导电部3331贴壁，保证消融效果。支撑体3310径向尺寸最大的位置位于其近端与远端之间，且靠近近端的位置，支撑体3310植入至左心耳10后，第一导电部3331位于左心耳10内部。由于支撑体3310采用单盘结构，且支撑体3310径向尺寸最大的位置位于支撑体3310的近端与远端之间，便于支撑体3310植入并固定于左心耳内腔。在变更实施方式中，所述支撑体不同轴向位置上的侧壁的径向尺寸相同。
在一些实施例中，第一导电部3331及/或第二导电部3332中的至少部分能够用于采集组织生理信号，即消融件3330具有消融和标测功能。在一些实施方式中，第一导电部3331中的部分组件可以仅用于标测，不具有消融作用。在一些实施方式中，第一导电部3331中的部分组件用于标测，部分组件具有消融作用。在一些实施方式中，第一导电部3331的至少部分组件分时用于标测以及消融作用。在一些实施方式中，第二导电部3332中的部分组件可以仅用于标测，不具有消融作用。在一些实施方式中，第二导电部3332的部分组件用于标测，部分组件具有消融作用。在一些实施方式中，第二导电部3332的至少部分组件分时用于标测以及消融作用。
输送器3320包括内鞘管3321和消融导管3323。内鞘管3321与支撑体3310连接。输送器3320包括套接于内鞘管3321外的外鞘管3322，外鞘管3322与内鞘管3321之间可相对移动，内鞘管3321的远端与支撑体3310连接，消融导管3323的近端连接于外鞘管3322的远端。完成消融后，消融导管3323可回收于套装于外鞘管3322外的外导管(图未示)中。消融导管3323用于释放在密封部3311近侧。消融导管3323上设置有第二导电部3332。具体地，消融导管3323包括设置于外鞘管远侧的多根支撑杆3324，多根支撑杆3324在支撑体3310近端释放后呈伞状，构成伞状架体。
具体地，消融导管3323包括多根围绕其轴线向四周辐射状设置的支撑杆3324，多根支撑杆3324的近端结合在外鞘管3322的远端，支撑杆3324被释放后，每根支撑杆3324呈向支撑体3310方向凸出的弧线形。每根支撑杆3324远离其近端的一端为自由端，该自由端用于向近端延伸。第二导电部3332设置于支撑杆3324上。
第二导电部3332可以为支撑杆3324的一部分或全部，或者是设置于支撑杆3324上的电极件。本实施例中，每个支撑杆3324周向的末端均设置有电极件，第二导电部3332的径向尺寸较大，且大于第一导电部3331的径向尺寸，便于特征电场线E穿过口部组织。可以理解地，支撑杆3324上的电极件的数量可以根据需要进行调整，也可以在一些支撑杆3324上不设置电极件。
由于第二导电部3332设置在消融导管径向尺寸较大的周向边缘区域，从而便于第二导电部3332容易在释放后贴靠至左心耳口部的近侧组织。支撑体3310径向尺寸最大的位置位于其近端与远端之间，这样将支撑体3310植入左心耳时，支撑体3310的密封部3311用于植入至左心耳口部远侧，支撑体3310的密封部3311不会遮盖左心耳口部，避免支撑体3310与伞状架体相互干涉。在自然状态下(未受到外力作用)，或者是在消融过程中，第二导电部3332的围成环形结构的径向尺寸大于第一导电部3331的围成环形结构的径向尺寸，即第一导电部3331与第二导电部3332中，位于近侧的导电部的围成环形结构的径向尺寸大于位于远侧的导电部的围成环形结构的径向尺寸，使得特征电场线E的远侧向支撑体轴线的方向倾斜，方便第一导电部3331与第二导电部3332之间的至少一条特征电场线穿过容纳部外侧的左心耳组织，保证消融效果。本实施方式中，容纳部是支撑体3310与支撑杆3324相互朝向并靠近的部分。
可以理解地，第一导电部3331与第二导电部3332可以是设置于支撑体3310或者支撑杆3324上的各种形式的电极，如点状电极、杆状电极、圆弧电极、圆环电极、波浪电极中的至少一种。第一导电部3331 也可以是支撑体3310的至少一部分，第二导电部3332可以为支撑杆3324的至少一部分，比如支撑体3310为导电金属材料通过编织以及/或者切割工艺制成的镂空网格结构。第一导电部3331为支撑体3310的至少一部分，也可以为支撑体3310的全部。在一些实施方式中，消融导管3323的支撑杆3324由导电金属材料通过编织以及/或者切割工艺制成；第二导电部3332为支撑杆3324的至少一部分，也可以为支撑杆3324的全部。
第一导电部3331与第二导电部3332的数量均可以为多个。如图33所示，支撑体3310上设置有多个第一导电部3331，具体数量为两个，分别设置于密封部3311和锚定部3312，优选地，两个第一导电部3331用于传输极性相反的脉冲消融能量，并构成消融回路。可以理解的是，多个第一导电部3331可以均设置于密封部3311或均设置于锚定部3312。第一导电部3331中包括多个电极的实施方式中，第一导电部3331中的多个电极之间可以间隔设置或互相接触。第二导电部3332的多个电极之间可以相互间隔设置或者相互连接。在本实施方式中，第二导电部3332中包括多个电极，在其他实施方式中，可以设置多个第二导电部3332，每个第二导电部3332中包括至少一电极或至少一段支撑杆。在一些实施方式中，全部的第二导电部3332用于标测。
本申请提供的消融系统3300，与现有技术相比，可通过第一导电部3331，与第二导电部3332相互配合，实现对目标组织脉冲消融。
以下以消融系统3300为左心耳封堵消融系统为例进行说明，即用于对左心耳10进行封堵与消融。
消融系统包括左心耳封堵消融装置以及输送器3320。左心耳封堵消融装置包括支撑体3310，以及消融件3330中的第一导电部3331。支撑体3310连接至输送器3320，第一导电部3331通过输送器3320连接脉冲消融仪。在一些实施方式中，第一导电部3331通过输送器3320经线缆连接至脉冲消融仪。在一些实施方式中，支撑体3310上的设置有覆膜，覆膜用于阻挡左心耳中的血栓流出至左心房。
在一些实施方式中，第一导电部3331和第二导电部3332均设置在支撑体3310上，该两个导电部用于传输参数相同或不同的消融电能，比如用于传输极性不同的消融电能。在本实施方式中，支撑体3310设置有第一导电部，第二导电部设置于输送器3320，比如设置于支撑体3310近端的输送器3320的消融导管。在其他实施方式中，设置有第二导电部的消融导管用于在支撑体3310的远侧释放。在一些实施方式中，第二导电部独立于支撑体3310、输送器3320设置，用于在消融过程中贴附于生物体表面。
在本实施方式中，第一导电部3331、第二导电部3332满足前述实施方式中提供的参数，比如在消融过程中，在距离第一导电部3331以及第二导电部3332在距离各自表面3mm的位置产生的电场强度大于400V/cm。在一些实施方式中，消融系统3300用于对于左心耳10以外的心脏组织进行消融，比如肺静脉厚度一般为2mm，保证在消融过程中，距离消融件3330表面2mm的位置处，其产生的电场强度大于心肌阈值场强，比如大于400V/cm，从而便于实现透壁消融。
在消融件3330设置于支撑体3310及/或输送器的实施方式中，消融件3330(第一导电部、第二导电部)采用的脉冲电压范围为500V～4000V，第一导电部3331的放电面积为15mm2～4700mm2，第二导电部3332的放电面积为15mm2～4700mm2。导电部具有多个电极件时，放电面积的取值范围是指该导电部所有放电面积(电极件或骨架)的总和。第一导电部3331和第二导电部3332表面距离最近的两点之间的距离的取值范围为1mm～45mm。优选地，第一导电部3331和第二导电部3332间的距离可进一步限定为3mm～22mm。在此范围内，能够便于两个导电部的消融区部分重叠。消融系统用于对心肌组织进行消融，第一导电部3331周围形成的电场强度大于心肌阈值强度的区域为第一消融区，第二导电部3332周围形成的电场强度大于心肌阈值强度的区域为第二消融区。在轴向上两个消融区部分重叠后形成消融区的尺寸较大。
图35中的支撑体3310上设有两个第一导电部3331，在一些实施方式中，可根据实际应用需求择其一使用。
在频率范围为500Hz～3MHz，电压范围为500V～4000V的条件下，消融区对应电场强度大于等于400V/cm的电场分布区域时，消融区围绕导电部表面设置，两个消融区在轴向上部分重叠形成的消融区，在轴向上的尺寸大于单独任意一个消融区的轴向尺寸，这样便于将两个消融区的能量集中起来对一个部位进行消融，提高待消融区域的消融成功率。也就是说，即使在装置植入至左心耳口部11后，密封部3311的周向边缘区域存在部分位置贴靠性不佳的问题，由于消融件3330在轴向上具有尺寸较大的消融区，相对于两个分离的轴向尺寸较小的消融区，更容易在密封部3311的周围形成透壁消融。
采用消融区部分重叠的方式，在轴向上具有近端部分与远端部分，即使近端部分由于贴壁性不佳，其外缘难以覆盖到左心耳外壁，远端部分可能覆盖到左心耳外壁，从而降低由于密封部3311释放后的贴壁 条件对封堵消融系统3300的消融效果的影响，提高系统消融的成功率。
在本实施方式中，第一导电部3331设置于密封部3311，第一消融区与第二消融区部分重叠后形成的消融区分布于左心耳口部11，以便对左心耳口部11进行消融。左心耳口部组织相对于左心耳内部组织，表面平滑，形状规则，第一导电部3331比较容易贴壁，厚度相对均匀，消融区便于在口部形成连续的透壁消融。
由于左心耳壁厚一般在3mm，重叠的两个消融区的边界与导电部表面之间的距离较大，超过左心耳壁厚，因此可以实现透壁消融。
结合参阅图35、图36，本实施例的消融系统3300的操作方法包括以下步骤：
步骤A：利用输送器3320将左心耳封堵消融装置输送左心耳开口处进行释放以对左心耳开口封堵。具体地，将左心耳封堵消融装置释放到左心耳10之后，内鞘管3321保持与封堵消融装置连接，释放出第二导电部3332(消融导管3323)；待第二导电部3332贴近左心耳口部近侧组织时，固定消融导管3323的位置，同时开启脉冲消融源；第一导电部3331与第二导电部3332在脉冲能源作用下，形成的至少一条特征电场线E穿过口部组织，便于在口部进行透壁消融。破坏细胞内外环境稳态，达到电隔离效果，保证位于消融组织两侧的左心耳10与左心房12之间不能传递电生理信号，达到治疗房颤的目的。消融完成后释放连接钢缆。
步骤B：撤回消融导管3323，完成手术。
步骤C：消融导管3323单独进行消融作用。具体地，在DSA造影或者超声引导下，将消融导管3323定位到左心耳口部11，将第二导电部3332贴近左心耳口部近侧组织，固定消融导管3323的位置，同时脉冲消融源开启，第二导电部3332的电极间用于传输极性不同的脉冲消融能量。第二导电部3332的多个电极围成环形，便于在左心耳10内，左心耳口部11以及左心耳口部近侧、肺静脉以及心房中形成透壁的环形消融带。
步骤C可以在步骤A之前，和/或在步骤A与步骤B之间实施，可以根据需要对消融导管3323与封堵消融装置的释放顺序进行调整，二者的释放顺序没有相互制约关系。在一些实施方式中，步骤C可省略。
第三十四实施方式
图37为本申请第三十四实施方式的消融系统3400的结构示意图。
本实施例的消融系统3400与第三十三实施方式的消融系统3300相似，相同部分请参考上述关于第三十三实施例的描述，在此不再赘述。本实施例相较于第三十三实施例的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管3423包括外鞘管3422以及设置于外鞘管3422远端的多根支撑杆。第一导电部3431设于支撑体3410近侧的外周壁上。第二导电部3432设于多根支撑杆上，第二导电部3432可以为多根支撑杆的一部分，也可以是多根支撑杆的全部或者是设置在多根支撑杆上的电极件。
多根支撑杆中的每个支撑杆围成一个支撑环，多个支撑环在周向上依次设置。每个支撑环在垂直于支撑体轴线的平面上的投影呈环形，在本实施方式中，该环形为扇形，在其他实施方式中，该环形可以为圆环形，椭圆环形，部分环形，或者是其他规则或不规则的环形。相邻的支撑环在在垂直于支撑体轴线的平面上的投影具有重叠的部分。在其他实施方式中，相邻支撑环在该平面上的投影不重合，或者重合的部分更小，或者更大。
支撑杆的两端在轴向上的位置不重合，即在轴向上错开，从而增大每个支撑环的支撑性能。在一些实施方式中，支撑环的两端在轴向上的位置相同，可以连接在一起，或者是间隔设置。
支撑环的边缘部分能够较佳的贴靠组织壁，保证消融与标测的效果。
在一些实施例中，支撑体3410采用单盘或多盘结构，第二导电部3432设置于输送器3420。第二导电部3432能够相对于支撑体3410移动，第二导电部3432用于释放于支撑体3410的近侧，第一导电部3431邻近设置于支撑体3410的近端。第一导电部3431与第二导电部3432之间的距离可调节的较近，使得输送器3420远端的消融导管与密封部3410上的第一导电部3431配合效果好。
第三十五实施方式
图38为本申请第三十五实施方式的消融系统3500的结构示意图。
本实施例的消融系统3500与第三十四实施方式的消融系统200相似，相同部分请参考上述关于第三十四实施方式的描述，在此不再赘述。本实施例相较于第三十四实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管3523为包括设于外鞘管3522远端的网盘结构，该网盘结构可采用编织或者切 割工艺制成。如图38所示，网盘结构为双层网盘，即在网盘结构的轴线方向(图中上下方向)上网盘结构包括两层编织网，两层编织网在周向边缘相互连接。在其他一些实施方式中，网盘结构为单层网盘，即在网盘结构的轴线方向(图中上下方向)上网盘结构仅仅包括单层编织网。
第二导电部3532设置在编织网盘上。第一导电部3531设于支撑体3510近侧的外周壁上。第二导电部3532可以是网盘结构的部分，或者是网盘结构的全部，这样整个编织网盘可以作为一电极向组织传输消融能量。在一些实施方式中，第二导电部3532可以是设置于网盘结构的电极。
第三十六实施方式
图39为本申请第三十六实施方式的消融系统3600的结构示意图。
本实施例的消融系统3600与图35中的第三十三实施方式的消融系统3300相似，相同部分请参考上述关于第三十三实施方式的描述，在此不再赘述。本实施例相较于第三十三实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管3623为内鞘管3621，内鞘管3621的远端与支撑体3610可拆卸连接。内鞘管3621呈杆状或管状，第二导电部3632设置在内鞘管3621的外周侧壁上。第二导电部3632可以是电极或者是内鞘管3621中导电件裸露的一部分。第一导电部3631设于支撑体3610近侧的外周壁上。
第三十七实施方式
图40为本申请第三十七实施方式的消融系统3700的结构示意图。
本实施例的消融系统3700与第三十三实施方式的消融系统100相似，相同部分请参考上述关于第三十三实施方式的描述，在此不再赘述。本实施例相较于第三十三实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，输送器3720包括外鞘管3722以及穿设于外鞘管3722内腔的内鞘管3721，输送器3720中的消融导管4023为设置于外鞘管3722远端的球形网格结构。第二导电部3732为设置于球形网格结构的周向边缘区域至少一波浪电极，以便于在消融过程中第二导电部3732贴紧组织。球形网格结构可以采用编织或切割工艺制成，球形网格结构可径向伸缩和膨胀。未受到外力作用的自然状态下，球形网格结构可以为圆球、椭球等规则或不规则的球形。第一导电部3731设于支撑体3710近侧的外周壁上。
输送器3720采用双层鞘管，内鞘管3721穿设于外鞘管3722中，并可以作为输送导管与支撑体3710连接。球形网格结构的远端与内鞘管3721的远端连接。当球形网格结构执行消融功能之前，可通过内外鞘管调节球形网格结构以及第二导电部3732的直径。具体可通过固定内鞘管3721，向远端推进外鞘管3722，和/或牵拉内鞘管3721的方式进行调节。球形网格结构被压缩，从而增大第二导电部3732的径向尺寸，并使其边缘贴靠在左心耳口部外侧组织。消融结束后，通过内外鞘管的调节增大球形网格结构的轴向长度，直至球形网格结构能够收束以便于输送。
可以理解地，未受到外力作用的自然状态下，球形网格结构可以为圆球、椭球、柱状等规则或不规则的封闭结构。
第三十八实施方式
图41为本申请第三十八实施方式的消融系统3800的结构示意图。
本实施例的消融系统3800与第三十七实施方式的消融系统3700相似，相同部分请参考上述关于第三十七实施方式的描述，在此不再赘述。本实施例相较于第三十七实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管3823为设于输送器3820上的球囊。球囊内部填充介质后，在左心耳口部外侧膨胀开，球囊充盈后的形态为盘状，第二导电部3832设置在充盈后的球囊的外周边缘，消融完成后将球囊回收至输送器中。支撑体3810靠近近侧的周向外侧面上设置第一导电部3831。
第三十九实施方式
图42为本申请第三十九实施方式的消融系统3900的结构示意图。
本实施例的消融系统3900与第三十三实施方式的消融系统3300相似，相同部分请参考上述关于第三十三实施方式的描述，在此不再赘述。本实施例相较于第三十三实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，输送器3920包括外鞘管3921以及设置在外鞘管3921远端的消融导管3923，自然状态下，消融导管3923呈环形，第二导电部3932设于消融导管3923上。消融导管3923围绕外鞘管3921的轴线方向盘绕呈平面环形或立体环形，消融导管3923外绕外鞘管3921轴线环绕至少一圈，可以为多圈。第二导电部3932包括多个沿消融导管3923长度方向间隔设置的部分，比如沿消融导管3923轴向依次间 隔设置的多个电极件。第二导电部3932可以是消融导管3923的一部分或者全部，可以间隔设置的，也可以是连续设置的。支撑体3910靠近近侧的周向外侧面上设置第一导电部3931。
第四十实施方式
图43为本申请第四十实施方式的消融系统4000的结构示意图。
本实施例的消融系统4000与图35提供的第三十三实施方式的消融系统3300相似，相同部分请参考上述关于第三十三实施方式的描述，在此不再赘述。本实施例相较于第三十三实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，输送器4020包括内鞘管4021、外鞘管4022以及消融导管4023。消融导管4023包括多根支撑杆4024。内鞘管4021穿设于外鞘管4022中。各支撑杆4024的远端结合在一起，且连接在内鞘管4021远端，各支撑杆4024的近端结合在一起，连接于外鞘管4022远端。支撑杆4024呈螺旋状，便于装载与释放时的形变。并且消融过程中，通过牵拉输送器4020的内鞘管4021，及/或向远端推送外鞘管4022，改变支撑杆4024的径向尺寸。即在轴向上压缩支撑杆4024，支撑杆4024径向上尺寸扩大，螺旋形的支撑杆4024在口部容易适应组织形态，在发生形变后贴靠组织，并不会对组织产生较大的压迫力。螺旋形的支撑杆4024上设置的第二导电部4032用于对组织进行消融。支撑体4010靠近近端的周向外侧面上设置第一导电部4031。
各支撑杆4024在径向尺寸压缩到一定程度后，螺旋形的支撑杆4024之间在轴向上容易相互层叠，形成用于贴靠口部外侧(近侧)组织的结构，即形成稳定的盘面结构。每根支撑杆4024上间隔设置有第二导电部4032中的多个电极件。优选地，第二导电部4032至少设置在支撑杆4024处于轴向尺寸压缩状态下，径向尺寸较大的区域中，以便于在口部外侧的边缘区域对组织进行消融。完成消融后，各支撑杆4024可回收于外鞘管4022中。在一些实施方式中，支撑杆4024也可以没有螺旋角度。
第四十一实施方式
图44为本申请第四十一实施方式的消融系统4100的结构示意图。
本实施例的消融系统4100与第四十实施方式的消融系统4000相似，相同部分请参考上述关于第四十实施方式的描述，在此不再赘述。本实施例相较于第四十实施方式的主要不同在于：支撑体的结构不一样。
本实施例中，支撑体4110呈单盘柱状结构，可以采用编织或切割工艺制成。支撑体4110近侧的外周设有第一导电部4131，第一导电部4131为圆环电极。第二导电部4132设在输送器4120上，第一导电部4131与第二导电部4132相互配合进行消融。
第四十二实施方式
图45为本申请第四十二实施方式的消融系统4200的结构示意图，图46为消融系统对左心耳组织进行消融作用的原理结构示意图。
本实施例的消融系统4200与图35中第三十三实施方式的消融系统3300相似，相同部分请参考上述关于第三十三实施方式的描述，在此不再赘述。本实施例相较于第三十三实施方式的主要不同在于：支撑体的结构及输送器的设置方式不一样。
本实施方式中提供的消融系统4200的支撑体4210以及第一导电部4231结构，与图23A以及图23B提供的左心耳封堵消融装置2100提供的支撑体以及第一导电部2150一致。
结合参考图45、图46，本实施例中，第二导电部4232设置于输送器，第二导电部4323能够相对于支撑体4210移动，用于释放于支撑体4210的远端侧。支撑体4210为双盘结构。支撑体4210结构与图21以及图22所示结构相似。支撑体4210包括密封部4211和锚定部4212，两者通过连接件4217连接并实现电隔离。支撑体4210内围成的空间中，沿轴线方向形成有通道。消融导管4223远端穿过该通道，并且能释放于锚定部4212的远侧。
密封部4211呈梯形，包括朝向锚定部4212的远端盘面4218、背离锚定部4212的近端盘面4219，以及在远端盘面4218与近端盘面4219之间的腰部4220。近端盘面4219与远端盘面4218大致呈平面状，腰部4220连接在近端盘面4219与远端盘面4218之间，腰部4220呈锥筒状。
第一导电部4231至少设置在密封部4211径向尺寸较大的边缘区域中，比如设置在腰部4220。优选地，第一导电部4231设置于密封部4211周向上径向尺寸最大的部分。本实施方式中，如图45所示，第一导电部4231设置在腰部4220以及近端盘面4219(图中虚线框部分)，或者设置于腰部4220、近端盘面4219以及至少一部分远端盘面4218。第一导电部4231为密封部4211中的部分第一骨架。密封部4211中不作为第一导电部4231的其余部分的表面可做绝缘处理。
具体地，密封部4211与图23A以及图23B中密封部2110的结构一致，与图21以及图22中提供的密 封部的主要区别在于，网格形式。密封部4211的近侧部分与远侧部分的网格大小不同，具体密封部4211的近侧部分的网格较小，数量多，密封部4211的远侧部分的网格较大，数量少。密封部4211中的小网格的第一骨架用于作为第一导电部，密封部4211中的大网格的第一骨架表面做绝缘处理。具体地，小网格部分采用密网编织的工艺形成，大网格部分为小网格部分中的多股编织丝呈束延伸得到，每束编织丝中的多股编织丝之间相互固定。大网格部分中的第一骨架相互之间不存在能够相互摩擦的交叉点，或者相对于小网格区域能够相互摩擦的交叉点密度较低，比如两束编织丝之间可能会出现相互摩擦，便于在大网格区域中的第一骨架上进行绝缘处理。可以理解的是，密封部4211还可以采用其他的绝缘方式，或增设其他的绝缘方式，比如设绝缘套管，设置覆膜等方式。
锚定部4212结构与图21以及图22中相同呈盘状。锚定部4212包括多根锚定杆，锚定杆包括依次连接的锚定一杆4213、锚定二杆4214、锚定三杆4215以及锚定四杆4216。锚定一杆4213的近端与绝缘连接件4217连接，锚定一杆4213在近端与远端之间延伸。相邻的两个锚定二杆4214远离锚定三杆4215的一端相连接，并与对应的锚定一杆4213连接。锚定三杆4215在近端与远端之间延伸，且位于锚定部4212的外周侧，用于贴靠左心耳内壁。锚定三杆4215的近端连接对应的两个锚定二杆4214。锚定二杆4214在周向上首尾相接形成锯齿状结构。锚定四杆4216远离锚定三杆4215的一端向轴线方向延伸，并且向远端延伸。相邻的两个锚定四杆4216的远离锚定三杆4215的一端连接在一起，能提高锚定部4212的力学性能，避免相邻的锚定四杆4216在锚定部4212径向形变的过程中相互钩挂，提高支撑体4210的可靠性。每个锚定三杆4215上间隔设置有两个点状电极。
消融导管4223的结构与图35中提供的消融导管，同样采用伞状架体。消融导管4223包括多根围绕其轴线向四周辐射状设置的支撑杆4224，每个支撑杆4224周向的末端均设置电极件，这样在伞状架体周向末端形成第二导电部4232。
本实施方式中的消融导管4223与图35中的消融导管的区别在于，消融导管4223用于释放在支撑体4210的远侧。
具体地，结合参阅图45、图46，通过输送器4240将支撑体4210输送至左心耳开口处，密封部4211的腰部4220贴靠在左心耳开口处，腰部4220上的第一导电部4231贴靠在左心耳近侧组织，锚定三杆4215贴靠左心耳内壁。开启脉冲消融源，第一导电部4231和第二导电部4232之间的特征电场线穿过口部组织，便于在口部进行透壁消融。完成消融后释放支撑体4210，撤回消融导管4223。本实施例的消融导管4223远端穿过支撑体4210轴向的通道，并且能释放于锚定部4212的远侧。
在其他实施例中，支撑体采用其他实施方式提供的结构，输送器上的第二导电部的释放位置，可以根据支撑体的具体结构适应性地改变，如支撑体的锚定部呈杯状，且远端开口，第二导电部可释放于支撑体的远端侧，具体第二导电部可释放于锚定部内、支撑体的远端或超过支撑体的远端。
第四十三实施方式
图47为本申请第四十三实施方式的消融系统4300的结构示意图。
本实施例的消融系统4300与第四十二实施方式的消融系统4200相似，两者支撑体结构以及消融导管的设置方式相同，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管4323的结构与图37对应的第三十四实施例的消融导管的结构相同，第二导电部4332设于支撑环上，其支撑环的结构不再赘述。与第三十四实施例消融系统200不同的是：本实施例的消融导管4323远端穿过支撑体4310轴向的通道，并且能释放于锚定部4312的远侧。第三十四实施例的消融导管释放于密封部的近侧。
第四十四实施方式
图48为本申请第四十四实施方式的消融系统4400的结构示意图。
本实施例的消融系统4400与图45对应的第四十二实施方式的消融系统4200相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管4423的结构与图38对应的第三十五实施方式的消融导管3523的结构相同，消融导管4423同样采用网盘结构，第二导电部4432设置在网盘结构上。第一导电部4431设置在密封部4411上。与第三十五实施方式消融系统不同的是：本实施例的消融导管4423远端穿过支撑体4410轴向的通道，并且能释放于锚定部4412的远侧。第三十五实施方式的消融导管释放于密封部的近侧。
第四十五实施方式
图49A与图49B为本申请第四十五实施方式的消融系统4500的结构示意图。
本实施例的消融系统4500的锚定部4512表面设置有覆膜4590，覆膜4590用于实现阻流作用，以及第二导电部4532与锚定部4512之间的绝缘作用。
本实施例的消融系统4500与图45对应的第四十二实施方式的消融系统4000相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，在输送状态下，消融导管4523呈直线状收容于输送器的外层导管中，消融导管4523在锚定部4512远侧从外层导管中释放出来后，消融导管4523远离支撑体4510的一端沿径向向外的方向弯曲延伸，可盘绕呈环形(图52中消融导管4823的形状)。在一些实施方式中，消融导管4523从外层导管中释放出来后也呈直线状，第二导电部4532设置在消融导管4523的侧壁上。第一导电部4531设置在密封部4511上。第二导电部4532可以是电极或者是消融导管4523中导电件裸露的一部分。
在一些实施方式中，锚定部4512设置有第三导电部，用于向组织释放脉冲消融能量。在图49A至图49B中，第三导电部可以是设置于锚定部4512表面的电极件，或者是锚定部4512中的部分第二骨架。
第一导电部4531、第二导电部4532以及第三导电部中的至少一个用于对组织释放脉冲消融能量；在一些实施方式中，第一导电部4531、第二导电部4532以及第三导电部全部均用于释放脉冲消融能量；在一些实施方式中，第一导电部4531与第三导电部用于释放脉冲消融能量，即第一导电部4531与第三导电部用于传输极性相反的脉冲消融能量，并用于构成消融回路。第二导电部4532用于采集目标组织的电生理信号；在一些实施方式中，第一导电部4531、第二导电部4532以及第三导电部中的至少一个用于分时进行消融与标测。
请参阅图49C，图49C为基于图49A中第四十五实施方式的变更实施方式，本实施方式提供的消融系统4500C与第四十五实施方式中的消融系统4500的区别在于，锚定部4512C表面设置有第三导电部4533C，第三导电部4533C具体为波浪电极。第三导电部4533C的波峰与波谷对应锚定部4512C中的锚定三杆设置。
锚定部4512C表面设置有锚刺4519C，锚刺4519C设置于第三导电部4533C远侧，避免第一导电部4531C与第三导电部4533C同时放电进行消融的过程中锚刺4519C产生火花。
请参阅图49D与图49E，图49D与图49D提供的消融系统4500D为基于图49C中的消融系统4500C的变更实施方式，本实施方式消融系统4500D与消融系统4500C的区别在于，第三导电部4533D的波峰与波谷与锚定部4512D的锚定三杆4513D错开设置，第三导电部4533D可以通过波峰与波谷连接至覆膜4590D，从而避免第三导电部4533D的波峰与波谷连接于覆膜4590D的位置形成穿孔，第三导电部4533D与锚定部4512通过该穿孔相互短路，从而提高第三导电部4533D与锚定部4512D之间的绝缘性能。
第四十六实施方式
图50为本申请第四十六实施方式的消融系统4600的结构示意图。
本实施例的消融系统4600与图45对应的第四十二实施方式的消融系统4200相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，第一导电部4631设置在密封部4611上。消融导管4623为球形网格结构，第二导电部4632设置于球形网格结构的周向边缘区域。球形网格结构与图40对应的第三十七实施方式的球形网格结构相同，在此不再赘述。与第三十七实施方式消融系统不同的是：本实施例的消融导管4623远端穿过支撑体4610轴向的通道，并且能释放于锚定部的远侧。第三十七实施方式的消融导管释放于密封部的近侧。
第四十七实施方式
图51为本申请第四十七实施例的消融系统4700的结构示意图。
本实施例的消融系统4700与图45对应的第四十二实施方式的消融系统1000相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管4723为球囊，与图41对应的第三十八实施方式提供的消融导管结构相似。球囊内部填充介质后，在左心耳口部外侧膨胀开。球囊充盈后的形态为盘状，第二导电部4732设置在充盈后的球囊的外周边缘，消融完成后将球囊回收至外鞘管中。第一导电部4731设置在密封部4711上。本实施例的消融导管4723远端穿过支撑体4710轴向的通道，并且能释放于锚定部4712的远侧。第三十八实施方式的消融导管释放于密封部的近侧。
第四十八实施方式
图52为本申请第四十八实施方式的消融系统4800的结构示意图。
本实施例的消融系统4800与图45对应的第四十二实施方式的消融系统4200相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，消融导管4823为环体，与图42对应的第三十九实施方式提供的消融导管结构相似。第二导电部4832设于环体上，第一导电部4831设于密封部4811上。第二导电部4832包括多个沿环体轴向间隔设置的部分，比如沿环体轴向依次间隔设置的多个电极件。第二导电部4832可以是环体的一部分或者全部，可以间隔设置的，也可以是连续设置的。本实施例的消融导管4823远端穿过支撑体4810轴向的通道，并且能释放于锚定部4812的远侧。第三十九实施方式的消融导管释放于密封部的近侧。
第四十九实施方式
图53为本申请第四十九实施方式的消融系统4900的结构示意图。
本实施例的消融系统4900与图45对应的第四十二实施方式的消融系统4200相似，相同部分请参考上述关于第四十二实施方式的描述，在此不再赘述。本实施例相较于第四十二实施方式的主要不同在于：支撑体的结构及第一导电部的设置方式不一样。
本实施例中，支撑体4910为双盘结构。第二导电部4932设置于输送器，第二导电部4932能够相对于支撑体4910移动，用于释放于支撑体4910的远端侧。第一导电部4931邻近设置于支撑体4910的近端。支撑体4910包括密封部4911和锚定部4912，两者通过连接件4913连接并实现绝缘连接。密封部4911采用轴向长度较短的圆盘状结构。锚定部4912呈杯状，其远端开口。锚定部4912可采用金属丝编织制成，或者通过切割管材制成。锚定部4912的金属丝的远端沿径向向内收束于连接件4913处。第一导电部4931设置于锚定部4912外周侧的表面。第一导电部4931为圆环电极。
本实施例的消融导管4923与第四十二实施方式的消融导管4223的结构相同，消融导管4923同样采用伞状架体，消融导管4923包括多根围绕其轴线向四周辐射状设置的支撑杆4924，每个支撑杆4924周向的末端均设置电极件，这样在伞状架体周向末端形成第二导电部4932。由于锚定部4912远侧呈敞口状，消融导管4923可以释放于锚定部4912的内部。
第五十实施方式
图54为本申请第五十实施方式的消融系统5000的结构示意图。
本实施例的消融系统的结构与图53对应的第四十九实施方式的消融系统4900相似，相同部分请参考上述关于第四十九七实施方式的描述，在此不再赘述。本实施例相较于第四十九实施方式的主要不同在于：消融导管的结构不一样。
本实施例中，第二导电部5032设置于输送器，第二导电部5032能够相对于支撑体5010移动，用于释放于支撑体5010内部。支撑体5010的锚定部5012呈杯状，且远端开口，第二导电部5032可释放于锚定部5012内。消融导管5023为球囊。球囊内部填充介质后，在左心耳口部外侧膨胀开，球囊充盈后的形态为盘状。支撑体5010包括相连接的密封部5011和锚定部5012。第一导电部5031为固定于锚定部5012外周壁上的圆形电极。第二导电部5032设置在充盈后的球囊的外周边缘，消融完成后将球囊回收至外鞘管5022中。由于锚定部5012远侧呈敞口状，球囊能释放于锚定部5012的内部。
可以理解的是，对于结构不同的支撑体5010，其锚定部5012远端开口的情况，比如锚定部5012呈柱状、杯状，对应的消融导管5023可以释放于锚定部5012的内部。在第四十九实施方式和第五十实施方式中，其消融导管5023可以释放于对应的锚定部5012的内部。第二导电部5032可以扩大径向尺寸，通过穿过锚定部5012的网格接触组织，或者不需要进行扩大径向尺寸的形变，通过接触血液对左心耳组织进行消融。
第五十一实施方式
图55为本申请第五十一实施方式的消融系统5100的结构示意图。
本实施例中，支撑体5110为双盘结构，第一导电部5131和第二导电部5132均设置在支撑体5110上。
支撑体5110包括密封部5111和锚定部5112，密封部5111包括第一骨架5113，锚定部5112包括第二骨架5117。锚定部5112的第二骨架5117采用金属丝编织制成，且编织成的第二骨架5117为内外双层。具体地，金属丝沿锚定部5112的近端向远端扩散延伸，形成第二骨架5117的内层，然后从远端向近端翻折绕回，编织形成第二骨架5117的外层。
第二导电部设置于锚定部5112的第二骨架5117，本实施方式中，第二导电部为设置于第二骨架5117 上的第二电极件，第二电极件作为第二导电部5132。第二骨架5117中，未与第二电极件连接的其余部分的表面绝缘，即锚定部5112可以设置为仅第二骨架5117中未与第二电极件对应的部分的表面绝缘。
优选地，第二导电部5132采用圆环电极，即第二电极件为圆环电极，圆环电极固定在锚定部5112周向外壁面上。锚定部5112设置为第二骨架5117整体的表面均绝缘，圆环电极为额外设置的电极。具体可通过在第二骨架5117上设置覆膜实现第二骨架5117的表面绝缘。第二骨架5117中与第二电极件对应的部分为第二骨架5117与第二电极件接触的部分，相应地，第二骨架5117中未与第二电极件对应的部分即为第二骨架5117中未与第二电极件接触的部分。可以理解的，在其他一些实施例中，第二电极件也可以设置为沿周向弯折延伸的结构，例如锯齿状、波浪形等。
具体地，第一骨架5113为金属丝编织成型的结构。密封部5111包括背向锚定部5112的盘面5114、朝向锚定部5112的盘底5115以及连接在盘面5114与盘底5115之间的腰部5116。其中，盘面5114的直径大于盘底5115的直径，且盘面5114的直径略大于左心耳的内径。支撑体5110植入左心耳后，盘面5114压住左心耳开口处，盘底5115塞入左心耳内。盘底5115的直径与左心耳内径大致一致。第一电极件设置在密封部5111的腰部5116处，作为第一导电部5131，从而与左心耳口部贴合。
同时，本实施例示出的支撑体5110中，密封部5111上的第一导电部5131为第一骨架5113的一部分，锚定部5112上的第二导电部5132为设置在第二骨架上的第二电极件。可以理解的，也可以根据需求采用具体选择骨架或者额外设置电极件的方式。
第五十二实施方式
图56为本申请第五十二实施方式的消融系统5200的结构示意图。
本实施例的消融系统5200的支撑体5210的结构与图55对应的第五十一实施方式的支撑体5110的结构相似，相同部分请参考上述关于第五十一实施方式的描述，在此不再赘述。本实施例相较于第五十一实施方式的主要不同在于：第二导电部设置的位置不一样。
本实施例中，支撑体5210上沿轴线间隔地设置两个第一导电部5231，分别设置在密封部5211和锚定部5212上。密封部5211上设置的第一导电部5231为至少部分第一骨架，锚定部5212上的第一导电部5231为固定在外壁面的圆环电极。第二导电部5232设置在输送器5220上。
输送器5220包括消融导管，第二导电部5232为设于消融导管，本实施方式中，消融导管呈网盘结构，与图38对应的第三十五实施方式提供的消融导管结构相似。优选地，第二导电部5232可以是网盘的全部，这样整个编织网盘可以作为一电极向组织传输消融能量。本实施例的输送导管远端穿过支撑体5210轴向的通道，并且能释放于锚定部5212的远侧。
在一些实施例中，可以对锚定部做绝缘处理。比如，在锚定部的第二骨架上设置绝缘涂层，或者设置绝缘套管，或者锚定部由绝缘材料制成。通过对锚定部做绝缘处理，可避免锚定部5212与第二导电部5232相互接触导电，避免导致第二导电部5232放电面积增大的问题出现，提高了系统的稳定性，提升消融成功率。
第五十三实施方式
图57为本申请第五十三实施方式的消融系统5300的结构示意图。
本实施例的消融系统5300是用于对心脏中的肺静脉、心房、左心耳，或者心脏以外待消融组织进行消融。支撑体为径向可伸缩和扩张的骨架。消融系统5300包括设于远端的支撑体5310和设于近端的输送器5320。支撑体5310连接于输送器5320的远端，用于沿着输送路径将支撑体5310输送至待消融组织的附近，进行释放，并实现组织消融。支撑体5310能够通过输送器5320调节径向尺寸，进而实现径向的收缩和扩张。具体输送器5320包括外鞘管5322和内鞘管5321，内鞘管5321穿设于外鞘管5322的内腔中。支撑体5310的近端连接于外鞘管5322的远端，支撑体5310的远端连接于内鞘管5321的远端，可通过对输送器5320的外鞘管5322和内鞘管5321进行调节，使两者相对移动，来实现支撑体5310径向尺寸的调节，如向近侧牵拉内鞘管5321及/或向远侧推送外鞘管5322，使外鞘管5322和内鞘管5321之间发生相对移动。
本实施例中，支撑体采用具有变径结构的支撑体5310，即支撑体5310扩张时形成大径端和小径端，大径端的最大径向尺寸大于小径端的最大径向尺寸，大径端靠近近端设置，小径端靠近远端设置。大径端的轴向长度大于小径端的轴向长度。
支撑体5310在大径端与小径端的连接处形成容纳部5330，容纳部5330相对于第一导电部5331及/或第二导电部5332邻近支撑体5310的轴线设置，本实施方式中，容纳部5330相对于第一导电部5331及第二导电部5332邻近支撑体5310的轴线设置，即在支撑体5310上形成凹陷区域，容纳部5330外壁的外侧 形成用于容纳待消融组织的容纳空间，这样便于特征电场线E穿过位于容纳空间的组织。优选地，穿过容纳空间的至少一条特征电场线E相对于支撑体5310轴线倾斜，这样支撑体5310的容纳部5330便于容纳更多的组织，能减小特征电场线E在容纳空间中穿过组织的难度。在本实施方式中，第一导电部5331设于大径端的远侧，第二导电部5332设于小径端的近侧，第一导电部5331的径向尺寸大于第二导电部5332的径向尺寸，即位于近侧的导电部形成环形结构的径向尺寸大于位于远侧的导电部形成环形结构的径向尺寸，这样穿过容纳空间的至少一条特征电场线E相对于支撑体5310的轴线倾斜，便于特征电场线穿过容纳空间中的组织。
可以理解地，支撑体5310也可以采用其它的变径结构，如近端和远端的径向最大尺寸相等，近端和远端之间形成有容纳部，第一导电部5331的径向尺寸与第二导电部5332的径向尺寸不相等，这样穿过容纳空间的至少一条特征电场线E也相对于支撑体5310的轴线倾斜，便于特征电场线穿过容纳空间中的组织。
如图57所示，容纳部5330相对于第一导电部5331及第二导电部5332邻近支撑体5310的轴线设置，特征电场线E穿过容纳空间，穿过容纳空间的电场线较为密集，电场强度越大，位于容纳空间的组织更容易被消融；第一导电部5331和第二导电部5332设于容纳空间相对的两侧，第一导电部5331的径向尺寸大于第二导电部5332的径向尺寸，穿过容纳空间的至少一条特征电场线E相对于支撑体5310的轴线倾斜。
具体地，支撑体5310包括沿支撑体5310轴线周向间隔设置的多根支撑杆5311，支撑杆5311的数量具体可以是4根、6根、8根或更多。各支撑杆5311的远端相接在一起，近端相接在一起。每根支撑杆5311包括依次连接第一弧形段5312、第二弧形段5313和第三弧形段5314。支撑体5310扩张时，第一弧形段5312和第三弧形段5314均朝远离骨架中心轴线的方向弯曲，第二弧形5313段朝靠近骨架中心轴线的方向弯曲，使得支撑体5310在第二弧形段5313处形成容纳部5330；第一弧形段5312的径向尺寸大于第三弧形段5314的径向尺寸，第一弧形段5312的轴向尺寸大于第三弧形段5314的轴向尺寸。在其他实施方式中，第一弧形段5312的轴向尺寸不大于第三弧形段5314的轴向尺寸。
第一导电部5331设置于第一弧形段5312与第二弧形段5313的连接处，第二导电部5332设置于第二弧形段5313与第三弧形段5314的连接处。即第一导电部5331位于容纳部5330的近侧，第二导电部5332位于容纳部5330的远侧。支撑体5310扩张时，第一导电部5331的径向尺寸大于第二导电部5332的径向尺寸。输送器5320将支撑体5310输送至目标区域，容纳部5330贴靠在肺静脉或者左心耳口部，特征电场线E可穿过组织。
如图57所示，每个支撑杆5311在轴向上的不同位置套有两个环状电极，这样在支撑体5310上形成围绕轴向两圈间隔的电极，第一导电部5313包括围绕轴向一圈间隔的多个电极，第二导电部包括围绕轴向的另一圈间隔的多个电极。
在本实施方式中，容纳部5330两侧的导电部在轴向上间隔设置。容纳部5330延伸方向也可以介于周向和轴向之间，或者是不规则的。两侧的导电部设置在容纳部5330相对的两侧，从而使得特征电场线E穿过支撑体5310外部的区域，进而在消融过程中容易穿过组织，形成透壁消融。
在其它一些实施例中，支撑体5310也可以替换为球囊，如采用切割或编织工艺制成的球囊，球囊在径向上可收缩和扩张。球囊中填充有介质，通过控制对内部介质的体积来调节球囊的径向尺寸。
第五十四实施方式
图58为本申请第五十四实施方式的消融系统5400的结构示意图。
本实施例中，第一导电部5431和第二导电部5432均设置在支撑体5410上，即第一导电部5431和第二导电部5432沿轴向间隔地设置在支撑体5410上。支撑体5410呈近端大、远端小的结构，即支撑体5410近端的径向尺寸大于远端的径向尺寸。骨架在第一导电部5431和第二导电部5432之间的位置设置有容纳部。可以理解地，对于不同形状和结构的支撑体，其形成的容纳部及外侧对应的容纳空间不同，在本实施例中，密封部5411与锚定部5412之间形成的容纳部。
具体地，第一导电部5431设于支撑体5410的近侧，具体设置于密封部5411，第二导电部5432位于第一导电部5431的远侧，具体设置于锚定部5412，两者在支撑体5410的位置其径向尺寸不同，第一导电部5431的径向尺寸大于第二导电部5432的径向尺寸。支撑体5410输送至左心耳开口时，第一导电部5431与第二导电部5432之间的特征电场线E容易穿过支撑体5410中容纳部外侧的区域，两导电部之间的支撑体5410用于贴靠组织，消融过程中便于特征电场线穿过组织。
支撑体5410包括相接的密封部5411和锚定部5412，锚定部5412上设有锚刺5413。当去掉锚刺5413后，可以作为消融导管对肺静脉以及左心耳等区域进行消融操作。可以理解地，第一导电部5431中的部 分组件可以仅用于标测，不具有消融作用。在一些实施方式中，第一导电部5431中的部分组件用于标测，部分组件具有消融作用。在一些实施方式中，第一导电部5431的至少部分组件分时用于标测以及消融作用。可以理解地，第二导电部5432中的部分组件可以仅用于标测，不具有消融作用。在一些实施方式中，第二导电部5432中的部分组件用于标测，部分组件具有消融作用。在一些实施方式中，第二导电部5432的至少部分组件分时用于标测以及消融作用。
具体地，支撑体5410包括骨架5414。骨架5414表面可以设置用于阻挡血栓的阻隔件(比如覆膜)，阻隔件的数量以及设置位置不做限定，为清楚起见，图58中并未示出阻隔件。骨架5414包括第一骨架5415、第二骨架5416以及绝缘件5417。第一骨架5415与第二骨架5416均由导电材料制成，第一骨架5415与第二骨架5416之间通过绝缘件5417连接。第一骨架5415与第二骨架5416分别用于向目标组织区域传输极性不同的消融能量。
第一骨架5415与第二骨架5416均可采用生物相容性较好的金属材料或高分子聚合物材料制成。金属材料可以采用镍钛合金、钴铬合金、不锈钢以及可降解金属材料，优选超弹性形状记忆合金镍钛丝制成。绝缘件5417采用生物相容性较好的绝缘材料制成。在一些实施方式中，第一骨架5415与第二骨架5416由编织工艺制成。在一些实施方式中，第一骨架5415与第二骨架5416其中之一采用编织工艺制成，其中之另一采用切割工艺形成。
骨架5414的制作过程为：分别利用导电管材切割制作第一骨架5415与第二骨架5416，绝缘件5417通过熔融连接、插接连接及卡接连接中的一种或多种方式连接在第一骨架5415与第二骨架5416之间。
如图58所示，第一骨架5415与第二骨架5416在轴向上分隔设置，绝缘件5417围绕支撑体5410的轴线围成环形的绝缘区域。消融件5430包括设置于第一骨架5415的第一导电部5431以及设置于第二骨架5416的第二导电部5432。本实施方式中，第一导电部5431为第一骨架5415的至少一部分，第二导电部5432为第二骨架5416的至少一部分，第一骨架5415上第一导电部5431以外的区域表面做绝缘处理，第二骨架5416上第二导电部5432以外的区域表面做绝缘处理，即第一骨架5415与第二骨架5416均通过部分支撑杆表面对目标组织区域进行消融。
在本实施方式中，第一骨架5415与第二骨架5416均为切割制成，形成有多个网孔，绝缘件5417连接在第一骨架5415与第二骨架5416之间呈直杆状。在变更实施方式中，绝缘件5417中的每个支撑杆呈弧线形、折线形、环形，或者绝缘件5417在轴向上占据的尺寸较图58较大。绝缘件5417中的多根支撑杆相互连接形成网孔，即不限定绝缘件5417的具体形式。在变更实施方式中，第一骨架5415与第二骨架5416中的至少一个可以通过编织获得。
在本实施方式中，第一导电部5431与第二导电部5432均为骨架5414的一部分，在变更实施方式中，第一导电部5431与第二导电部5432中的至少一个是额外设置于骨架5414(第一骨架5415或第二骨架5416)上的消融电极，消融电极与对应骨架之间可以保持电连接，或者是与骨架绝缘通过导线连接至外部消融信号源。
如图58所示，第一骨架5415与第二骨架5416之间在轴向上间隔。在变更实施方式中，第一骨架5415与第二骨架5416之间在周向上间隔设置，比如第一骨架5415设置于支撑体5410周向上的第一角度范围内，第二骨架5416设置于支撑体5410周向上的第二角度范围内，第一骨架5415与第二骨架5416之间通过绝缘件5417连接。
在变更实施方式中，第一骨架5415与第二骨架5416之间在周向以及轴向上间隔。
由于密封部5411用于覆盖左心耳开口，更容易覆盖左心耳开口处周向一圈，因此第一导电部5431设置于密封部5411有利于在左心耳口部形成完整的环形消融区域，提高消融效果。优选地，第一导电部5431设置于密封部5411的周向边缘区域。第一导电部5431可设置在密封部5411的近侧边缘，中间段的边缘，以及远侧边缘中的至少一个，第一导电部5431优选设置在密封部5411上能够贴靠左心耳口部一圈的区域设置。在密封部5411上的各个位置，与密封部5411轴线之间的距离是一定的。在一些实施方式中，周向边缘区域是指密封部5411上，与密封部5411轴线的距离最大的20％的区域。在一些实施方式中，周向边缘区域是指密封部5411上，与密封部5411轴线的距离最大的10％的区域。在一些实施方式中，周向边缘区域是指密封部5411上，与密封部5411轴线的距离最大的5％的区域。在一些实施方式中，周向边缘区域是指密封部5411上，与密封部5411轴线的距离最大的3％的区域。可以理解的是，具体边缘区域的认定，可以根据实际需要进行设定，在这里不做限定。
在变更实施方式中，第一导电部5431与第二导电部5432中的至少一个为消融电极。第一导电部5431与第二导电部5432中，可设置更多的消融电极，不同的消融电极之间间隔设置，不限定不同消融电极各 自的设置位置。
请参阅图59，图59为本申请第五十五实施方式提供的消融系统5500的结构示意图。消融系统5500为具体为消融导管，可以用于对心内组织或心脏以外待消融组织进行消融。消融系统5500包括支撑体5510和输送器5520，支撑体5510连接于输送器5520的远端，输送器5520在图59中仅示出了连接支撑体5510的导管部分。
基于本实施方式中提供的消融系统5500与图58提供的消融系统的区别在于，支撑体5510，第一导电部5531以及第二导电部5532的结构。
具体地，本实施方式提供的支撑体5510大致呈球体，支撑体5510可以呈球形、椭球形或接近于球形的形状。支撑体5510包括近侧部分与远侧部分，其近侧部分用于连接输送器5520，远侧部分相对于近侧部分远离输送器5520设置。支撑体5510的远侧部分表面设置有第二导电部5532，支撑体5510的近侧部分表面设置有第一导电部5531。
第一导电部5531与第二导电部5532中的至少一个可以采用本申请其他实施方式提供的任意一种或几种电极件的形式实现。可以理解的是，也可以采用支撑体的骨架的导电部分作为第一导电部5531与第二导电部5532中的至少一个。
在一些实施方式中，支撑体5510的近侧部分通过编织或切割工艺形成网格结构，该网格结构中的至少部分采用导电金属材料制成，其中至少部分导电网格用于作为第一导电部5531。
在一些实施方式中，支撑体5510的远侧部分设置的第二导电部5532包括一个或多个电极件，电极件可以选择点状电极、杆状电极、圆弧电极、波浪电极等形式。
第一导电部5531与第二导电部5532用于构成消融回路，用于传输极性相反的脉冲信号，两者之间相互绝缘。支撑体5510远侧部分的结构与近侧部分的结构相同，均为相同的网格结构。或者，支撑体5510在近侧部分设置有图59所示的网格结构，支撑体5510的远侧部分设置有其他形式的支撑结构，比如密度不同、网格形状不同的其他网格结构，或者呈网篮形。
在一些实施方式中，第二导电部5532与支撑体5510之间相互绝缘，具体绝缘方式请参考前述实施方式；在一些实施方式中，支撑体5510的近侧部分与远侧部分之间通过绝缘件连接。
在采用本实施方式提供的消融系统5500进行消融的过程中，支撑体5510的远侧部分用于贴靠目标组织壁，需要利用第二导电部5532贴靠目标组织壁并进行消融，第二导电部5532的贴壁条件优于第一导电部5531，第二导电部5532相较于第一导电部5531的预期消融深度较大，因此设置第二导电部5532的放电面积小于第一导电部5531，从而实现第二导电部5532平均电流密度更大，从而扩展第二导电部5532的消融范围与消融深度。
本实施方式中的第一导电部5531与第二导电部5532可以采用前述其他实施方式中的具体参数，在这里不做赘述。
需要说明的是，以上实施例中的具体技术方案在不违背本发明技术原理的情况下可以相互适用。比如，在以上实施方式的基础上，将第一导电部与第二导电部的具体形式在利用骨架导电、或额外设置点状电极、杆状电极、圆弧电极、圆环电极、波浪电极等形式之间的变换，或者将第二导电部的具体设置位置更换为密封部，锚定部，连接件，输送器，或支撑体以及输送器以外的位置，或者在支撑体上设置更多个上述的第一导电部与第二导电部，或者将以上实施方式中的密封部、锚定部、消融导管相互组合以得到新的消融系统，都属于本申请的发明内容。以上各个实施方式中第一导电部与第二导电部，均可以采用本申请实施方式提供的电场强度、电压、平均电流密度、距离、面积等参数，并且均可以采用第一消融区与第二消融区部分重叠的技术方案。以上各个实施方式中支撑体均可以设置用于容纳组织的并设置于两个导电部之间的容纳部，至少一条特征电场线穿过容纳部外侧的容纳空间，以及穿过容纳空间的至少一条特征电场线的远端朝向支撑体轴线倾斜。朝向支撑体轴线倾斜，是指该穿过容纳空间的至少一条特征电场线与支撑体轴线之间既不平行也不垂直，在如上述实施方式对应附图所示，该穿过容纳空间的至少一条特征电场线在特征平面上的投影，与支撑体轴线之间能够形成两个夹角，两个夹角度数相加为180度，其中较小的一个夹角为锐角。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请的保护范围之内。

Claims (20)

  1. 一种消融系统，其特征在于，所述消融系统包括支撑体以及消融件，至少部分所述消融件设置于所述支撑体，所述消融件包括第一导电部与第二导电部，所述第一导电部与所述第二导电部用于构成回路传输脉冲消融能量，且二者极性相反，所述第一导电部与所述第二导电部的平均电流密度不相等。
  2. 如权利要求1所述的消融系统，其特征在于，在自然状态下，所述第一导电部与所述第二导电部在轴向上间隔，所述第一导电部设置于所述第二导电部的近侧，在消融过程中，所述第二导电部表面的平均电流密度大于所述第一导电部表面的平均电流密度。
  3. 如权利要求2所述的消融系统，其特征在于，所述第一导电部与所述第二导电部均用于对目标组织进行消融，所述第一导电部的贴壁条件优于所述第二导电部。
  4. 如权利要求2所述的消融系统，其特征在于，所述第二导电部的放电面积小于所述第一导电部的放电面积。
  5. 如权利要求4所述的消融系统，其特征在于，所述第一导电部的放电面积为15mm2～4700mm2，所述第二导电部的放电面积为15mm2～500mm2。
  6. 如权利要求5所述的消融系统，其特征在于，所述支撑体包括金属材质的骨架，所述第一导电部与所述第二导电部设置于所述支撑体，所述第一导电部为至少部分所述金属材质的骨架，所述第二导电部为设置于所述支撑体上的至少一电极件。
  7. 如权利要求6所述的消融系统，其特征在于，所述电极件为杆状电极、点状电极、圆弧电极、绕环所述支撑体外周延伸至少一圈的条状或丝状电极。
  8. 如权利要求4所述的消融系统，其特征在于，自然状态下，所述第二导电部的近端设置于所述第一导电部远端的远侧。
  9. 如权利要求1-8任意一项所述的消融系统，其特征在于，所述第一导电部的消融区为，所述第一导电部周围形成的电场强度大于目标组织阈值强度的区域；所述第二导电部的消融区为，所述第二导电部周围形成的电场强度大于目标组织阈值强度的区域；所述第一导电部的消融区与所述第二导电部的消融区部分重叠。
  10. 如权利要求9所述的消融系统，其特征在于，所述第一导电部和所述第二导电部间的距离为3mm～22mm。
  11. 如权利要求10所述的消融系统，其特征在于，所述第一导电部与所述第二导电部表面距离最近的两点之间的距离的取值范围为3mm～18mm。
  12. 如权利要求8所述的消融系统，其特征在于：连接所述第一导电部上的任意一点，与所述第二导电部上任意一点之间的直线，为一条特征电场线，至少一条所述特征电场线穿过所述支撑体外壁外侧的区域。
  13. 如权利要求12所述的消融系统，其特征在于，所述第一导电部与所述第二导电部设置于所述支撑体，所述支撑体包括容纳部，在径向上，所述容纳部相对于所述第一导电部及/或所述第二导电部邻近所述支撑体的轴线设置，所述容纳部周向外壁的外侧形成有用于容纳待消融组织的容纳空间，所述容纳部的外壁至少部分用于贴靠待消融组织，所述容纳部沿所述支撑体周向延伸，所述第一导电部和所述第二导电部设于所述容纳空间相对的两侧，在消融过程中，至少一条所述特征电场线穿过所述容纳空间。
  14. 如权利要求13所述的消融系统，其特征在于，所述第一导电部的径向尺寸大于第二导电部的径向尺寸。
  15. 如权利要求14所述的消融系统，其特征在于，自然状态下，选定的第一特征点与至少一第二特征点之间的特征电场线中长度最短的一个，在特征平面上的投影，与所述支撑体轴线之间夹角之间的角度为0°-70°，
    所述第一特征点，为所述第一导电部周缘径向尺寸最大处的点；
    所述第二特征点，为所述第二导电部周缘径向尺寸最大处的点；
    所述特征平面，为经过所述支撑体的轴线以及所述第一特征点的平面。
  16. 如权利要求1-5、8、12-15任意一项所述的消融系统，其特征在于，所述消融系统用于对左心耳实现封堵与消融，所述第一导电部设置于所述支撑体近侧部分的周向边缘区域，所述第二导电部设置于所述支撑体远侧部分的周向边缘区域。
  17. 如权利要求1-5、8、12-15任意一项所述的消融系统，其特征在于，所述消融系统用于对左心耳实现封堵与消融，所述支撑体包括相互连接的密封部和锚定部，所述密封部设置于所述锚定部的近侧，所述第一导电部设置于所述密封部的周向边缘区域，所述第二导电部设置于所述锚定部的周向边缘区域，所述第一导电部用于对左心耳口部组织进行消融，所述第二导电部用于对左心耳口部内侧组织进行消融，所述密封部与锚定部通过连接件进行绝缘连接。
  18. 如权利要求17所述的消融系统，其特征在于，所述锚定部包括第二骨架以及设置于所述第二骨架外表面的覆膜，所述第二骨架表面镀设有绝缘涂层，所述第二导电部设置于所述覆膜背离所述第二骨架的一侧表面上。
  19. 如权利要求1-5、8、12-15任意一项所述的消融系统，其特征在于，所述消融系统包括用于输送所述支撑体的输送器，所述输送器的远端与所述支撑体连接所述第一导电部设于所述支撑体上；
    所述第二导电部设于所述输送器，所述第二导电部能够相对于所述支撑体移动，用于释放于所述支撑体的近端侧或远端侧；或者
  20. 如权利要求1-19任意一项所述的消融系统，其特征在于：所述第一导电部及/或所述第二导电部中的至少部分能够用于采集组织生理信号。
    所述第二导电部相对于所述支撑体和所述输送器独立设置。
PCT/CN2023/107785 2022-07-28 2023-07-17 消融系统 WO2024022152A1 (zh)

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