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WO2023125866A1 - 消融封堵系统 - Google Patents

消融封堵系统 Download PDF

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Publication number
WO2023125866A1
WO2023125866A1 PCT/CN2022/143633 CN2022143633W WO2023125866A1 WO 2023125866 A1 WO2023125866 A1 WO 2023125866A1 CN 2022143633 W CN2022143633 W CN 2022143633W WO 2023125866 A1 WO2023125866 A1 WO 2023125866A1
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WO
WIPO (PCT)
Prior art keywords
ablation
electrode
support frame
insulating
coating
Prior art date
Application number
PCT/CN2022/143633
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English (en)
French (fr)
Inventor
程晓阳
王坤
尤岩
李建民
Original Assignee
杭州德诺电生理医疗科技有限公司
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Publication of WO2023125866A1 publication Critical patent/WO2023125866A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • 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
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—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

Definitions

  • the present application relates to the technical field of medical devices, in particular to an ablation and closure system.
  • Atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained arrhythmia, and with age, the incidence of atrial fibrillation continues to increase, reaching 10% in people over 75 years old.
  • the prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure. Due to its special shape and structure, the left atrial appendage is not only the most important site of atrial fibrillation thrombosis, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can benefit from active left atrial appendage electrical isolation).
  • One-stop treatment of "radiofrequency ablation + left atrial appendage closure” is one of the hot spots in the treatment of atrial fibrillation today.
  • many cases of atrial fibrillation have been successfully treated by using a one-stop treatment method combining catheter radiofrequency ablation and left atrial appendage closure.
  • the one-stop treatment method through the closure of the left atrial appendage, patients can still obtain good stroke prevention effects without taking anticoagulant drugs for life; combined with catheter radiofrequency ablation to restore and maintain sinus rhythm and improve patients with atrial fibrillation Symptoms can enable patients to obtain stable long-term therapeutic effects.
  • ablation methods are mainly: through pulmonary vein isolation (PVI) plus ablation of "atrial fibrillation focus" other than the pulmonary vein, without increasing left atrial appendage electrical isolation (unless the trigger focus from the left atrial appendage can cause persistent atrial fibrillation, atrial flutter or room rate).
  • PVI pulmonary vein isolation
  • ablation of "atrial fibrillation focus" other than the pulmonary vein without increasing left atrial appendage electrical isolation (unless the trigger focus from the left atrial appendage can cause persistent atrial fibrillation, atrial flutter or room rate).
  • the active catheters currently used to treat atrial fibrillation are all designed for pulmonary vein ablation. Due to the large differences in the size, depth, and location of the left atrial appendage in different patients, the existing pulmonary vein active catheters are obviously not suitable for Ablation of the left atrial appendage. Moreover, in order to perform ablation and occlusion of the left atrial appendage during the above-mentioned one-stop treatment process, it is necessary to introduce a movable catheter and the ablation and occlusion device of the left atrial appendage in an interventional manner. The key is to position the two devices successively on the left At the mouth of the atrial appendage, ablation and occlusion are performed separately.
  • the active catheter and the occlusion of the left atrial appendage are difficult to locate at the mouth of the left atrial appendage, the surgical procedure is complicated and time-consuming, which is not conducive to improving the "ablation + left atrial appendage occlusion" "The convenience of one-stop treatment and surgery.
  • the supporting frame of the existing ablation and occlusion device is directly electrically connected to the electrodes, which easily generates electric sparks and causes tissue damage.
  • the present application provides an ablation and occlusion system to solve the problem of the existing ablation and occlusion device, in which the supporting frame and the electrodes are directly electrically connected, and electric sparks are easily generated to cause tissue damage.
  • An embodiment of the present application provides an ablation and occlusion device, including:
  • the ablation and blocking device is connected to the distal end of the delivery device; the ablation and blocking device includes:
  • the electrode is arranged on the delivery device and/or the ablation and blocking device, and is located on the side of the covering membrane away from the supporting frame, and the electrode is connected to the supporting frame through the covering film Insulated, the electrode is used to ablate the tissue to be ablated.
  • the ablation and occlusion system includes a delivery device, an ablation and occlusion device, and electrodes.
  • the ablation and blocking device includes a support frame and a membrane. Based on the coating being arranged between the supporting frame and the electrode, so that the electrode is insulated from the supporting frame through the coating, so in the process of using the electrode to ablate the tissue to be ablated, the electric energy of the electrode will not be transmitted to the supporting frame, that is, it can Avoid the electrical coupling between the electrode and the support frame, which will lead to the conduction of the support frame, resulting in the expansion of the ablation area and shallow ablation depth, so as to ensure the safety, stability and ablation effect of the electrode ablation of the ablation and closure system.
  • the coating can also prevent the thrombus in the left atrial appendage from flowing out, so as to avoid problems such as cerebral embolism (stroke) and limb arterial embolism after the thrombus in the left atrial appendage falls off and flows to the whole body with blood.
  • stroke cerebral embolism
  • limb arterial embolism after the thrombus in the left atrial appendage falls off and flows to the whole body with blood.
  • Fig. 1 is a schematic structural diagram of an ablation and closure system provided in an embodiment of the present application.
  • FIG. 2 is a schematic structural diagram of a first embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • FIG. 3 is a schematic structural diagram of a second embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • FIG. 4A is a scanning electron microscope image of the covering film of the ablation and closure device in FIG. 2 and FIG. 3 .
  • FIG. 4B is a scanning electron micrograph of a conventional coating.
  • Fig. 5 is a schematic diagram of the supporting frame and electrode structure of the ablation and occlusion device in Fig. 2 .
  • FIG. 6 is a schematic structural view of the insulating coating provided on the support frame of the ablation and sealing device in FIG. 5 .
  • FIG. 7 is a schematic structural diagram of a third embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • FIG. 8A is a schematic structural diagram of a fourth embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • Fig. 8B is a structural schematic diagram of another angle of the ablation and occlusion device provided in Fig. 8A.
  • FIG. 9 is a top view of the ablation and closure device of the ablation and closure system in FIG. 2 .
  • FIG. 10 is a schematic structural diagram of a fifth embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • FIG. 11 is a schematic structural view of a sixth embodiment of the ablation and closure device of the ablation and closure system in FIG. 1 .
  • FIG. 12 is a schematic structural view of the supporting frame and electrodes of the ablation and closure device of the ablation and closure system in FIG. 11 .
  • Fig. 13 is a schematic structural diagram of a second embodiment of the ablation and closure system in Fig. 1 .
  • FIG. 14 is a schematic structural diagram of a partial structure of the ablation and closure system in FIG. 13 .
  • Fig. 15 is a partial structural schematic diagram of the third embodiment of the ablation and closure system in Fig. 1 .
  • the first pole 1010a The first pole 1010a
  • the first connection part 111 The first connection part 111
  • connection point 301
  • the first ablation piece 51 is the first ablation piece 51.
  • Control handle 202
  • the end of a medical device close to the operator is usually called the proximal end (ie, the operating end), and the end of the medical device away from the operator is called the distal end (ie, the insertion end).
  • the distal end refers to the end of the medical device that can be freely inserted into the animal or human body.
  • the proximal end refers to the end for user or machine operation or the end for connecting other devices.
  • the proximal end of a certain component in the LAA occlusion ablation device is the end of the component close to the left atrium
  • the distal end of a certain component is the end of the component close to the left atrial appendage
  • the mouth of the left atrial appendage refers to the position that enters the left atrial appendage from the left atrium.
  • the ablation and occlusion device provided in the embodiment of the present application is a left atrial appendage ablation and occlusion device, which is used to be implanted in the ostium of the left atrial appendage, and can perform electrical ablation on the left atrial appendage tissue, such as pulse ablation, radio frequency ablation or microwave ablation.
  • pulse ablation uses a high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field, so as to cause cell apoptosis to achieve non-thermal ablation of cells, so it is not affected by heat sink effect Influence.
  • IRE irreversible electroporation
  • the high-voltage pulse sequence produces less heat and does not need saline irrigation for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus.
  • the pulse ablation treatment time is short, the treatment time of applying a set of pulse sequences is less than 1 minute, and the whole ablation time is generally no more than 5 minutes.
  • different tissues have different response thresholds to pulsed electric fields, it is possible to ablate the myocardium without disturbing other adjacent tissues, thereby avoiding accidentally injuring tissues adjacent to the left atrial appendage.
  • Electrodes that release pulse energy can also collect intracardiac electrical signals. Before ablation, the collected intracardiac electrical signals are transmitted to the ECG synchronization instrument, so that the pulse output is synchronized in the absolute refractory period of myocardial contraction, so as not to interfere with the heart rate and reduce bursts. Cardiac arrhythmias; complete electrical isolation of tissue can also be judged by intracardiac signals after ablation procedures.
  • the ablation and occlusion system 1000 is a device that percutaneously intervenes in the human body to occlude defects in the occluded tissue and ablate the tissue to be ablated, so as to achieve the purpose of treating diseases (eg, atrial fibrillation, etc.).
  • the blocked tissue includes but not limited to left atrial appendage, foramen ovale, ductus arteriosus, atrial septum, interventricular septum, etc. It should be noted that in this application, the left atrial appendage is used as an example to illustrate the advantages of the ablation and closure system 1000 for treating the left atrial appendage. It can be understood that the blocking tissue may also be other tissues mentioned above.
  • FIG. 1 is a schematic structural diagram of an ablation and closure system 1000 provided in an embodiment of the present application.
  • the ablation and closure system 1000 includes an ablation and closure device 100 , a delivery device 200 and an electrode 300 .
  • the ablation and closure device 100 is connected to the distal end of the delivery device 200 .
  • the delivery device 200 is used to deliver the ablation and occlusion device 100 to the occluded tissue, such as the left atrial appendage.
  • the ablation and closure device 100 includes a support frame 101 and a membrane 102 .
  • the support frame 101 is made of conductive material.
  • the covering film 102 covers the support frame 101 .
  • the electrode 300 may be disposed on the ablation and closure device 100 .
  • the electrode 300 can also be disposed on the delivery device 200 .
  • the electrode 300 is located on the side of the coating 102 away from the support frame 101 .
  • the electrode 300 is insulated from the support frame 101 by the coating 102 .
  • the electrode 300 is used to ablate the tissue to be ablated.
  • the electric energy of the electrode 300 will not be transmitted to the support frame 101, that is, it can avoid the electrical coupling between the electrode 300 and the support frame 101, which will cause the support frame 101 to conduct electricity, and cause the ablation area to expand and The problem of shallow ablation depth; thus, the phenomenon of short circuit between the electrode 300 and the support frame 101 can be avoided, thereby ensuring the safety, stability and ablation effect of the ablation and blocking device 100 for ablation.
  • the covering film 102 can also prevent the thrombus in the left atrial appendage from flowing out, so as to avoid problems such as cerebral embolism (stroke) and limb arterial embolism caused by the thrombus in the left atrial appendage falling off and flowing to all parts of the body.
  • stroke cerebral embolism
  • limb arterial embolism caused by the thrombus in the left atrial appendage falling off and flowing to all parts of the body.
  • the delivery device 200 includes a sheath 201 for accommodating the ablation and occlusion device 100 and a control handle 202 fixed at the proximal end of the sheath 201 .
  • the control handle 202 is used to control the ablation and blocking device 100 to protrude from the distal end of the sheath tube 201 and release to the occluded tissue (left atrial appendage ostium); or to control the ablation and blocking device 100 to return to the sheath tube 201 Inside.
  • the control handle 202 is also used to control the advance, retreat and rotation of the sheath tube 201 in the blood vessel, and to control the ablation process of the electrode 300 .
  • FIG. 1 is only an example of the ablation and closure system 1000, and does not constitute a limitation to the ablation and closure system 1000, and the ablation and closure system 1000 may include more than those shown in FIG. 1 or Fewer components, or some components combined, or different components, for example, the ablation and closure system 1000 may also include a temperature sensor, a developing positioner, and the like.
  • the temperature sensor is used to detect the temperature of the target tissue during the ablation process to prevent the temperature from being too low or too high.
  • the electrode 300 can be used as an ablation electrode to realize ablation of the tissue area to be ablated.
  • the electrode 300 is externally connected with an energy generating device.
  • the energy generating device is used to provide ablation energy to the electrode 300 of the ablation and sealing device 100 during the ablation process, so that the electrode 300 transmits ablation energy to the tissue area to be ablated for ablation.
  • the energy generating device can output corresponding ablation energy according to the ablation parameters required by the tissue to be ablated in the tissue area to be ablated.
  • the ablation energy includes but not limited to at least one of radio frequency energy, microwave energy, pulse energy and the like.
  • the energy generating device is, for example, but not limited to one of a radio frequency generator, a microwave physiotherapy apparatus, a pulse generator or any combination thereof.
  • the electrode 300 can also be used as a mapping electrode to realize the mapping function.
  • the electrode 300 is connected to an external mapping device (not shown in the figure), and transmits the collected electrophysiological signals of the tissue region to be ablated to the external mapping device.
  • the electrode 300 is electrically connected to an external mapping device, and senses the physiological activity of the tissue to be ablated at the ablation site, thereby judging whether the ablation site has tissue to be ablated that needs to be ablated, thereby performing more targeted ablation of the tissue to be ablated , thereby improving the ablation effect, thereby improving the therapeutic effect of the operation, and providing a more accurate basis for the accurate positioning of the operation.
  • the number of electrodes 300 may include multiple, and multiple electrodes 300 are arranged at intervals, wherein some of the electrodes 300 are used to electrically connect the energy generating device to realize the ablation function, and some of the electrodes 300 are used to electrically connect to external mapping equipment , to realize the mapping function. In some other embodiments, the number of electrodes 300 may also include one.
  • each electrode 300 can be selectively used to perform an ablation function or a mapping function.
  • the electrode 300 is only used for ablation function or mapping function.
  • the ablation and blocking device 100 is a self-expanding stent.
  • the ablation and closure device 100 may be an elastic metal stent.
  • the ablation and closure device 100 is a nickel-titanium alloy stent.
  • the radial dimension of the ablation and occlusion device 100 is shrunk to a smaller state for delivery in the sheath tube 201; when the ablation and occlusion device 100 is delivered to the left atrial appendage ostium and released
  • the ablation and blocking device 100 can automatically expand to a predetermined shape and size to be supported on the inner wall of the left atrial appendage ostium, and the ablation and blocking device 100 can radially support the inner wall of the left atrial appendage, thereby being fixed on the left atrial appendage ostium.
  • the ablation and occlusion device 100 and the electrode 300 of the ablation and occlusion device 100 in FIGS. The state of the mouth of the left atrial appendage. After the ablation and occlusion device 100 is implanted in the ostium of the left atrial appendage, the ablation and occlusion device 100 is easily deformed because it conforms to different shapes of the left atrial appendage.
  • the covering film 102 is fixed on the support frame 101 .
  • the coating 102 can be formed by dipping, solution casting, spraying, tape casting, compression molding or injection molding, so that the porosity of the coating 102 is relatively small, thereby strengthening the coating. 102 insulation properties.
  • the molded coating 102 is fixed on the supporting frame 101 by suturing, hot pressing or bonding, so that the coating 102 can be attached to the outer surface of the supporting frame 101 to reduce the gap between the supporting frame 101 and the coating 102. Gaps are created at the junctions.
  • FIG. 2 is a schematic structural diagram of a first embodiment of the ablation and occlusion device 100 of the ablation and occlusion system 1000 in FIG. 1 .
  • the molded coating 102 is fixed on the support frame 101 by suturing.
  • a plurality of stitching points 103 arranged at intervals are formed at the joint between the edge of the covering film 102 and the support frame 101 .
  • the membrane 102 is sutured and connected to the support frame 101 at each suture point 103 by sutures.
  • suture points 103 there are multiple suture points 103, some of the suture points 103 are arranged on the proximal edge of the membrane 102, and some of the suture points 103 are located at other positions of the membrane 102, specifically on the far side of the electrode 300, and The far side of the anchor stab 13. In some embodiments, the suture points 103 are all disposed on the edge of the covering film 102 . In some embodiments, on the basis of FIG. 2 , the suture point 103 is also arranged at other positions of the membrane 102 to improve the connection strength between the membrane 102 and the support frame 101 .
  • the suture is sutured at least one turn along the circumferential direction of the support frame 101 .
  • the suture may be non-absorbable biocompatible suture such as but not limited to metal thread, cotton thread, polyester, polypropylene and the like.
  • Sutures can also be made of absorbable biocompatible sutures, such as but not limited to catgut, polyglycolide, multifilament non-biodegradable sutures, etc., so that the sutures will gradually degrade after being used for a certain period of time , which in turn helps to reduce the stimulation to the human body, thereby reducing the long-term complication rate of the long-term indwelling of the ablation and occlusion device 100 .
  • the suture thread can also be selected from winding fiber thread and the like.
  • the suture material includes, but is not limited to, at least one of polypropylene, polyethylene terephthalate, and polytetrafluoroethylene.
  • the material of the suture thread is polypropylene with good tensile strength and hardness.
  • the suture thread is a double-strand suture thread, so that the covering film 102 and the support frame 101 have better connection strength. In other embodiments, more strands of suture, or one strand of suture, can also be used as the suture.
  • FIG. 3 is a schematic structural diagram of a second embodiment of the ablation and occlusion device 100 a of the ablation and occlusion system 1000 in FIG. 1 .
  • the covering film 102 may be directly formed on the support frame 101 by dipping or spraying.
  • the covering film 102 of the present application is directly formed on the support frame 101 by dipping or spraying, so that the porosity of the covering film 102 is relatively small, thereby enhancing the insulation performance of the covering film 102, and the covering film 102 can be formed tightly on the
  • the outer surface of the supporting frame 101 is used to realize the seamless connection between the covering film 102 and the supporting frame 101 , so as to ensure good insulation between the electrode 300 and the supporting frame 101 .
  • FIG. 4A is a scanning electron microscope image of the coating 102 of the ablation and occlusion device 100a in FIG. 2 and FIG. 3, that is, FIG. 4A shows the embodiment of the present application
  • the scanning electron microscope image of the coating 102 that is, directly formed on the support frame 101 by dipping or spraying; or, by dipping, solution casting, spraying, tape casting, compression molding or injection molding.
  • FIG. 4B is the scanning electron micrograph of the existing film 102 produced by the electrospinning process. As shown in FIG.
  • the surface of the coating 102 has no defects, that is, the surface of the coating 102 is flat.
  • the scanning electron microscope image of Fig. 4A does not show that the coating 102 has obvious pores, which indicates that the porosity and pore size of the coating 102 made by the dipping process are small, and the coating 102 passes through to ensure that the coating 102 has better insulation. To avoid the problem of electrical conduction between the electrode 300 and the support frame 101 when the electrode 300 is in the energized state.
  • the insulation performance of the coating 102 is affected by the porosity and thickness of the coating 102, the thicker the coating 102, the better the insulation performance, but too thick a coating 102 will affect the ablation and blocking device 100. mechanical properties, and the degradation ability of the degradable coating 102 or increase the probability of some inflammations and chronic diseases in the body caused by the coating 102.
  • the porosity is less than 2.5%, and the thickness of the covering film 102 is 0.05mm-0.3mm.
  • the material of the coating 102 includes an insulating material, so as to avoid the electrical coupling between the electrode 300 and the support frame 101 when the electrode 300 is in the ablation state, so that the support frame 101 conducts electricity.
  • the covering film 102 is made of insulating material, so as to enhance the insulating performance of the covering film 102 as a whole.
  • the inner surface and/or the outer surface of the covering film 102 are both provided with an insulating coating.
  • the material of the coating 102 includes an insulating and degradable material, that is, the coating 102 is made of an insulating and degradable material, so as to ensure The insulation performance is good, and at the same time, it is beneficial to improve the biocompatibility of the ablation and closure device 100a.
  • the coating 102 will gradually degrade after being used for a certain period of time, and eventually become water and carbon dioxide that are easily absorbed and metabolized by the human body, thereby reducing the irritation to the human body, and further reducing the long-term indwelling of the ablation and blocking device 100a. long-term complication rate.
  • the insulating degradable materials include but are not limited to polylactic acid (polylactic acid, PLA), polycaprolactone (Polycaprolactone, PCL), or a copolymer or blend of several polymers.
  • the material of the covering film 102 may also include an insulating non-degradable material.
  • the non-degradable material has stable chemical properties, correspondingly, the structure is stable and not easily damaged, and the long-term mechanical properties, especially the mechanical properties, are relatively stable.
  • Insulating non-degradable materials include but are not limited to polyimide, polysulfone (Polysulfone, PSF), polysulfone resin (Polyethersulfone, PES), polyvinylpyrrolidone (Polyvinyl pyrrolidone, PVP), polymethyl methacrylate (Polymethyl methacrylate, PMMA), hydrogenated styrene-butadiene block copolymer (Styrene ethylene butylene styrene, SEBS), thermoplastic polyurethane elastomer (Thermoplastic polyurethanes, TPU), polyurethane (Polyurethane, PU), parylene, One of silicone rubber and other polymer materials or any combination of them.
  • FIG. 5 is a schematic structural view of the supporting frame 101 and the electrode 300 of the ablation and occlusion device 100a in FIG.
  • the covering film 102 is used to illustrate the structure of the supporting frame 101 and the electrode 300 and the relationship between the two. It should be noted that, for the structure and relative positional relationship of the supporting frame 101 and the electrode 300 shown in FIG. 3 , reference may be made to the corresponding description in FIG. 5 .
  • the support frame 101 is configured as a mesh structure.
  • the support frame 101 can be formed by weaving a braided wire with a shape memory effect to form a network structure; or, the support frame 101 can also be formed by cutting at least one of a rod-like structure, a tubular structure and a plate-like structure with a shape memory effect grid.
  • the material of the supporting frame 101 includes a biocompatible metal material, thereby enhancing the overall strength of the supporting frame 101 .
  • the material of the supporting frame 101 includes a non-degradable metal material.
  • the non-degradable metal material includes but not limited to at least one of stainless steel, tungsten alloy, cobalt-based alloy and nickel-titanium alloy. In some other embodiments, the material of the supporting frame 101 includes a degradable metal material.
  • the degradable metal material includes, but is not limited to, at least one of magnesium alloy, iron alloy or zinc alloy.
  • the material of the supporting frame 101 may also include or further include at least one of polymer materials, non-degradable non-metallic materials, degradable non-metallic materials or any combination thereof.
  • the ablation and occlusion device 100 is a left atrial appendage ablation and occlusion device.
  • the support frame 101 is configured as a double-layer network disk.
  • a double-layer network disk includes multiple mesh holes. The size and shape of the multiple mesh holes can be set according to actual needs, which are not specifically limited in this application.
  • the support frame 101 includes an anchoring portion 10 and a blocking portion 20 disposed at a proximal end of the anchoring portion 10 .
  • the anchoring part 10 is used for releasing inside the left atrial appendage and anchoring with the inner wall tissue of the left atrial appendage
  • the blocking part 20 is used for blocking the opening of the left atrial appendage to prevent the thrombus inside the left atrial appendage from flowing out.
  • Both the blocking part 20 and the anchoring part 10 can be provided with at least one choke film for blocking the outflow of thrombus inside the left atrial appendage. Outflow of thrombus inside the auricle causes stroke.
  • the anchoring part 10 and the blocking part 20 jointly form a multi-disc structure.
  • the anchoring part 10 and the blocking part 20 jointly form a double disc structure.
  • the anchoring part 10 forms an anchoring disc at the distal end of the supporting frame 101
  • the blocking part 20 forms a sealing disc at the proximal end of the supporting frame 101 .
  • the anchoring part 10 and the blocking part 20 together form a single disc structure.
  • FIG. 6 is a schematic structural view of the support frame 101 of the ablation and occlusion device 100 in FIG. 5 provided with an insulating coating 105 .
  • the support frame 101 includes a bearing section 104 .
  • the bearing section 104 is an axial section of the anchoring portion 10 .
  • the electrode 300 is arranged on the outer surface of the coating 102 away from the supporting frame 101; the electrode 300 is set corresponding to the bearing section 104, and the surface of the supporting framework 101 corresponding to the loading section 104 is provided with an insulating coating 105 or an insulating sleeve, so that the coating 102 and the insulating coating 105 or the insulating sleeve jointly play an insulating role, which not only improves the withstand voltage value of the supporting frame 101 , but also improves the reliability of the insulation between the supporting frame 101 and the electrode 300 .
  • the coating 102 when the coating 102 is damaged, the insulating coating 105 or insulating sleeve on the supporting frame 101 can still play the role of insulation between the supporting frame 101 and the electrode 300; When the insulating coating 105 or the insulating sleeve on the top is damaged, the coating 102 can still play the role of insulation between the supporting frame 101 and the electrode 300, thereby greatly improving the reliability and reliability of the insulation between the supporting frame 101 and the electrode 300. stability.
  • Both the anchoring part 10 and the blocking part 20 include a plurality of support rods 1010 , and the plurality of support rods 1010 together constitute a support frame 101 .
  • the bearing section 104 can be the entire area of the anchoring part 10, so as to facilitate the manufacturing process.
  • the anchoring part 10 can be made by a cutting process, and the surfaces of the cut support rods 1010 in the anchoring part 10 are all provided with an insulating coating and/or covered with insulating sleeves.
  • each supporting rod 1010 in the anchoring part 10 is composed of at least one braided wire combined into one strand, for example, each supporting rod 1010 includes a Braided wires, or each support rod 1010 includes a plurality of braided wires, the plurality of braided wires are combined into one strand, such as twisted into one strand, and an insulating sleeve is sheathed on the surface of the support rod 1010, and/or insulation is provided coating; or, the surface of each braided wire in each support rod 1010 of the anchoring part 10 is provided with an insulating coating, and/or passes through an insulating sleeve.
  • the carrying section 104 may be a partial area of the anchoring part 10 to save costs.
  • the bearing section 104 can also be arranged on the blocking part 20, such as being arranged on the proximal end of the blocking part 20; or, on the distal end of the blocking part 20; or, on the blocking part 20. or at least two of the proximal, middle, and distal parts of the blocking portion 20, thereby enhancing the electrode 300 provided on the anchoring portion 10 and the second electrode 300 that constitutes the blocking portion 20. Insulation performance between skeletons 21.
  • the covering film 102 covers the outside of the anchoring portion 10 .
  • the covering film 102 can partially or completely cover the outside of the anchoring part 10 to prevent thrombus in the left atrial appendage from entering the left atrium.
  • the covering film 102 is partially covered outside the anchoring part 10, and is located outside the distal end of the anchoring part 10, so as to prevent the thrombus from the left atrial appendage from flowing out of the anchoring part 10 along the direction of blood flow, and then Avoid thrombosis along with the blood flow to all parts of the body and cause cerebral embolism (stroke), limb arterial embolism and other problems.
  • the supporting frame 101 includes a first frame 11 and a second frame 21 .
  • the first skeleton 11 constitutes the anchoring portion 10 ; the second skeleton 21 constitutes the blocking portion 20 .
  • the covering film 102 covers the outside of the first framework 11 .
  • the coating 102 can also be used to constrain the hemispherical structure at the distal end of the first frame 11, making it difficult to deform to enhance structural stability, while increasing the direct contact area between the first frame 11 and the myocardial tissue, reducing the first
  • the material of the skeleton 11 has a certain protective effect on the stimulating effect on the myocardial tissue.
  • the electrode 300 is disposed on the ablation and closure device 100 .
  • the electrode 300 is disposed on the outer surface of the covering film 102 away from the support frame 101 , so as to realize the insulation arrangement of the electrode 300 and the support frame 101 .
  • the electrode 300 surrounds the membrane 102 at least once in the circumferential direction, thereby enhancing the ablation efficiency of the ablation and closure device 100 .
  • the electrode 300 is fixedly connected to the coating 102 .
  • the electrode 300 can be fixed on the covering film 102 by means of bonding, solution casting, sewing and the like.
  • the electrode 300 is fixedly connected to the covering film 102 and the supporting frame 101 .
  • the electrode 300 is sutured on the membrane 102 and the supporting frame 101 by sutures.
  • the sutures are made of insulating material, so as to further avoid electrical conduction between the electrodes 300 and the supporting frame 101 .
  • the suture material includes, but is not limited to at least one of polytetrafluoroethylene, polyglycolide, polyglycolide, polylactic acid, collagen, nylon suture, and polyester suture.
  • the suture is a suture made of polytetrafluoroethylene. The toughness of the suture is increased due to the high mechanical strength of the PTFE material.
  • the electrode 300 can be configured as a wire electrode or a sheet electrode. Specifically, when the electrode 300 is a wire electrode and the wire electrode is made into a wave structure, the wire electrode is fixedly connected to the covering film 102 at the crest and/or the valley of the wave structure.
  • the electrode 300 is formed with a plurality of connection points 301 at the peaks and troughs, and the electrode 300 is connected to the covering film 102 at the plurality of connection points 301 by bonding (or sewing, thermocompression), thereby avoiding the electrode 300 is displaced, thereby improving the ablation accuracy of the ablation and blocking device 100 .
  • the electrode 300 includes a link 302 connecting any two adjacent connection points 301 .
  • the electrode 300 is connected to the covering film 102 by bonding (or sewing, heat pressing) at multiple connection points 301 and multiple connecting rods 302, thereby further improving the stability of the connection between the electrode 300 and the covering film 102 sex and reliability.
  • the electrode 300 can also be configured as at least one of a point electrode, a columnar electrode, a cylindrical electrode, and a ring electrode.
  • the electrode 300 is configured as a wave structure, that is, the wire electrode is formed as a wave structure.
  • the electrode 300 is configured to be surrounded by a plurality of zigzag structures or a plurality of sinusoidal waveform structures, the electrode 300 includes a plurality of crests and a plurality of troughs, and the crests and troughs are arranged alternately in sequence.
  • the wave-shaped electrode 300 forms multiple turning points in its axial direction, wherein the turning point at the far end is defined as a peak, and the turning point at the proximal end is defined as a valley.
  • the material of the electrode 300 may be, but not limited to, one of platinum-iridium alloy, gold, nickel-titanium alloy, or stainless steel, or any combination thereof.
  • the electrode 300 is a wire electrode, and the wire electrode surrounds the anchoring part 10 in a circle.
  • the electrode 300 is a multi-turn wire electrode wound around the periphery of the support frame 101 , and the multi-turn wire electrodes are spaced apart from each other, and the electrode 300 can also be arranged on the blocking portion 20 .
  • the electrode 300 can be arranged in multiple turns around the periphery of the supporting frame 101 .
  • the wire electrode when the wire electrode is made into a wave structure, the wire electrode is in contact with the coating 102 and the first frame 11 at the crest and/or the valley of the wave structure.
  • the fixed connection improves the stability and reliability of the connection between the electrode 300 and the coating 102 and the first frame 11 .
  • the electrode 300 when the electrode 300 is configured as a point electrode, a columnar electrode or a cylindrical electrode, the point electrode, columnar electrode or cylindrical electrode and the first skeleton 11 can be staggered, and the covering film 102 The connection is fixed, so as to further improve the insulation performance between the electrode 300 and the supporting frame 101 .
  • the support frame 101 is provided with a plurality of anchor thorns 13 .
  • a plurality of anchor thorns 13 are arranged at intervals along the circumference of the outer surface of the support frame 101 .
  • a plurality of anchor thorns 13 are exposed relative to the coating 102 .
  • a plurality of anchor thorns 13 and the electrodes 300 are arranged in a staggered manner. Multiple anchors 13 are all disposed on the same side of the electrode 300 .
  • Surfaces of the plurality of anchor thorns 13 are all provided with an insulating coating. It can be understood that the insulating coating provided on the surface of the anchor thorns 13 is easily damaged.
  • the electrode 300 When the distance between the multiple anchor thorns 13 and the electrode 300 is relatively close, the electrode 300 is easily electrically coupled with the multiple anchor thorns 13, so that the multiple anchor thorns 13 are electrically coupled. Thorn 13 conducts electricity, especially the tip (ie free end or proximal end) of anchor thorn 13 is easy to discharge, and produces spark and eschar, even causes heart perforation to cause pericardial effusion.
  • a plurality of anchors 13 may be located on the proximal side and/or the distal side of the electrode 300 .
  • the plurality of anchors 13 can be arranged on other reasonable positions of the first frame 11, as long as the plurality of anchors 13 can penetrate into the inner wall of the left atrial appendage to enhance the anchoring performance of the ablation and closure device 100 without hindering the ablation and closure.
  • the electrodes 300 on the occlusion device 100 can ablate the inner wall of the left atrial appendage, which is not specifically limited in this application.
  • the plurality of anchor thorns 13 are integrally cut and formed with the first frame 11 , thereby improving the stability of the connection between the plurality of anchor thorns 13 and the first frame 11 and simplifying assembly.
  • the plurality of anchor thorns 13 can also be fixed on the first frame 11 by means of welding, bonding, mounting structure and the like.
  • a nickel-titanium metal wire or a nickel-titanium metal rod can be used as the anchor thorn 13 and fixed to the first skeleton 11 by means of a sleeve or welding.
  • the plurality of anchor thorns 13 are made of the same or different material as that of the first skeleton 11 .
  • a plurality of anchor thorns 13 are arranged on a plurality of straight rods in the middle of the first skeleton 11 .
  • a plurality of anchor stabs 13 extend toward the outside of the first frame 11 and toward the proximal end.
  • the number of multiple anchor thorns 13 is 5-15, which is not specifically limited here.
  • a receiving groove is opened on the first frame 11 at a position corresponding to each anchor thorn 13 .
  • Each anchor thorn 13 is movably received in the corresponding receiving groove.
  • each anchor 13 is accommodated in a corresponding receiving groove, thereby preventing the anchor 13 from scratching the occluded tissue;
  • Each anchor thorn 13 protrudes from the corresponding receiving groove, so that multiple anchor thorns 13 can penetrate into the inner wall of the left atrial appendage, thereby effectively preventing the ablation and occlusion device 100 from falling off.
  • a plurality of anchoring thorns 13 are disposed on the first frame 11 of the anchoring part 10 .
  • a plurality of anchor thorns 13 are arranged continuously or at intervals along the axial direction of the outer surface of the first skeleton 11 .
  • the plurality of support rods 1010 of the anchoring part 10 includes a plurality of first support rods 1010a and a plurality of second support rods 1010b.
  • Multiple first struts 1010a are disposed in the middle of the anchoring portion 10
  • multiple second struts 1010b are disposed on the distal and proximal sides of the anchoring portion 10 and the two ends of each first strut 1010a are connected The corresponding second strut 1010b.
  • Each anchor thorn 13 is disposed on the corresponding first pole 1010a.
  • the shape of the first strut 1010a may be but not limited to be a rod shape, and the shape of the second strut 1010b may be but not limited to be a V-shape, W-shape, Z-shape or S-shape.
  • Each first support rod 1010a can be connected to a plurality of second support rods 1010b, so as to improve the overall support strength and mechanical performance of the anchoring part 10 such as resilience.
  • one end of each first pole 1010a is connected with two second poles 1010b.
  • Each anchor thorn 13 is disposed on the outer surface of the corresponding first pole 1010a.
  • FIG. 7 is a schematic structural diagram of a third embodiment of the ablation and occlusion device 100c of the ablation and occlusion system 1000 in FIG. 1 .
  • the anchor barb 13 passes through the membrane 102 and is spaced apart from the electrode 300 .
  • the peaks and troughs of the plurality of anchor thorns 13 and the electrode 300 are staggered, so as to avoid a short circuit between the plurality of anchor thorns 13 and the electrode 300, and after the ablation and closure device 100c is implanted in the left atrial appendage, the plurality of anchor thorns 13
  • the inner wall of the left atrial appendage can be pierced to further anchor the ablation and occlusion device 100c, which can effectively prevent the ablation and occlusion device 100c from falling off.
  • a plurality of anchor thorns 13 are arranged on the proximal side of the electrode 300, and each anchor thorn 13 is arranged between two adjacent valleys of the electrode 300, thereby ensuring that a plurality of anchor thorns 13
  • the thorns 13 maintain an insulating distance from each part of the electrode 300 , thereby avoiding short circuits between the electrodes 30 , multiple anchor thorns 13 and the supporting frame 101 .
  • the proximal ends of the plurality of anchoring thorns 13 are approximately aligned with the troughs of the electrode 300, that is, the proximal ends of the plurality of anchoring thorns 13 are approximately at the same position as the troughs of the electrode 300. high.
  • the peaks of the plurality of anchoring thorns 13 are roughly aligned with the electrodes 300 , that is, the peaks of the electrodes 300 are directly opposite to the corresponding anchoring thorns 13 .
  • FIG. 8A is a schematic structural view of a fourth embodiment of the ablation and closure device 100 e of the ablation and closure system 1000 in FIG. 1 .
  • the amplitude of the electrode 300 can be reduced, that is, the range occupied by the electrode 300 in the axial direction is reduced, and the degree of fluctuation is more gentle, and/or the distance between the electrode 300 and the anchor barb 13 can be increased, so that in the An anchor thorn 13 may be provided at the position of each first strut 1010 a of the first frame 11 , so as to improve the anchoring performance of the anchoring part 10 .
  • the position where the electrode 300 is connected to the covering film 102 is staggered from the first frame 11 , that is, it is set corresponding to the mesh of the first frame 11 .
  • the electrode 300 is a wire electrode, and the wire electrode is made into a wave structure.
  • the crests and troughs of the corrugated structure are used to connect with the coating 102, and the crests and troughs of the corrugated structure are staggered from the first frame 11, so as to avoid the distance between the crests and troughs of the electrode 300 and the first frame 11 being too close , and after the crests and troughs of the electrode 300 are fixed (such as by bonding or suturing) on the coating 102, the risk of a short circuit between the crests and troughs of the electrode 300 and the support frame 101 will further increase the contact between the electrode 300 and the support. Insulation performance between skeletons 101.
  • a plurality of anchors 13 are disposed on the distal side of the electrode 300 . At least two anchoring thorns 13 are correspondingly arranged between two adjacent peaks of the electrode 300 , so that the anchoring performance of the anchoring part 10 can be further improved by increasing the number of anchoring thorns 13 . In this embodiment, two anchor thorns 13 are correspondingly arranged between two adjacent peaks of the electrode 300 . The free end of each anchor thorn 13 is spaced apart from the electrode 300, thereby avoiding the electrical coupling between the electrode 300 and multiple anchor thorns 13, causing the discharge of the tip of the anchor thorn 13 and generating sparks and eschar, and avoiding heart perforation and causing The phenomenon of pericardial effusion.
  • each anchor thorn 13 is arranged between two adjacent crests of the electrode 300, so as to ensure that multiple anchor thorns 13 maintain an insulating distance from various parts of the electrode 300, thereby preventing the electrode 30 from contacting multiple A short circuit occurs between the anchor thorn 13 and the supporting frame 101 .
  • the distal ends of the plurality of anchoring thorns 13 are approximately aligned with the positions of the peaks of the electrode 300, that is, the distal ends of the plurality of anchoring thorns 13 and the distal end of the electrode 300 are at the anchoring position.
  • the fixed part 10 is located approximately at the same height.
  • the plurality of anchor thorns 13 are roughly aligned with the troughs of the electrodes 300 , that is, the troughs of the electrodes 300 are directly opposite to the corresponding anchor thorns 13 .
  • the ablation and blocking device 100e also includes a wire 310 arranged on the support frame 101.
  • the wire 310 is made of a conductive material with better biocompatibility.
  • the wire 310 is electrically connected to the electrode 300, and the electrode 300 is used for Connect to an external pulse generator via wire 310.
  • the wire 310 and the electrode 300 are integrally structured, and in some implementations, the wire 310 and the electrode 300 are separate structures.
  • the wire 310 can be fixed on the outside of the coating 102 by suturing, bonding, hot pressing, etc., or can be fixed on the coating 102 and the first frame 101, for example, the wire 310 can be fixed on the coating 102 and the first frame 101 by suturing. , the suture thread passes through the membrane and winds the first frame 101 and the guide wire 310 .
  • the surface of the wire 310 is insulated. covered with insulating film.
  • the distal end of the insulating connector 40 has a conductive section, and the end of the wire 310 away from the electrode 300 is fixedly connected to the conductive section.
  • the conductive section is used for electrical connection of the delivery device, so that the electrode 300 passes through the wire 310 and the conductive section in sequence.
  • the delivery device is electrically connected to an external pulse generator.
  • the ablation and blocking device 100e further includes an ablation element 50 arranged on the supporting frame 101 for ablation of the tissue to be ablated.
  • the ablation and blocking device 100e is externally used
  • the pulse generator can transmit pulse energy with different polarities to the electrode 300 and the ablation element 50, so that the ablation and blocking device 100e performs bipolar ablation on the tissue.
  • a pulsed ablation electric field can be generated between the electrode 300 and the ablation element 50, and myocardial tissue within a certain range of electric field strength will be ablated by the pulse energy, thereby realizing irreversible electroporation.
  • the ablation element 50 and the plurality of anchors 13 are respectively disposed on both sides of the electrode 300 .
  • the insulating coating provided on the surface of the anchor thorns 13 is prone to damage. If multiple anchor thorns 13 are arranged between the ablation element 50 and the electrode 300, the pulse ablation generated between the electrode 300 and the ablation element 50 Under the action of the electric field, the tips of multiple anchor thorns 13 are prone to discharge, and sparks and eschars are generated, and even the heart is perforated to cause pericardial effusion.
  • multiple anchor thorns 13 are arranged on the distal side of the electrode 300, thereby reducing the problem that the tips of the multiple anchor thorns 13 are affected by the ablation electric field and causing tip discharge, thereby improving the ablation and occlusion device.
  • the ablation element 50 is disposed on the blocking portion 20 .
  • the ablation element 50 can be fixed on the second frame 21 independently of the second frame 21 of the blocking part 20, that is, it is a conductive element additionally provided on the second frame 21.
  • the ablation element 50 is insulated from the second frame 21 , so as to avoid a short circuit between the ablation element 50 and the electrode 300 .
  • the surface of the second frame 21 may be provided with an insulating coating or an insulating sleeve.
  • the ablation element 50 is arranged on the circumferential surface of the blocking part 20 so as to be as close as possible to the tissue of the mouth of the left atrial appendage, and the ablation element 50 forms at least one ring in the circumferential direction of the ablation blocking device 100e to protect the left atrial appendage.
  • a ring-shaped ablation zone is formed at the mouth.
  • the ablation element 50 serves as a part or the whole of the second frame 21 of the blocking portion 20 .
  • the ablation element 50 is used as a part of the second framework 21 of the blocking part 20, for example, the ablation element 50 is the edge part of the second framework 21 away from the anchoring part 10, so that the ablation element 50 can be attached to the ostium of the left atrial appendage. Tissues improve the success rate of ablation.
  • the part of the second frame 21 corresponding to the ablation element 50 is not insulated, and the rest of the second frame 21 except the ablation element 50 is insulated, so as to ensure the accuracy of ablation with the ablation element 50 .
  • the entirety of the second frame 21 can also serve as the ablation element 50 .
  • the external ablation energy source is a radio frequency signal source or a microwave physiotherapy apparatus
  • the second framework 21 can transmit a single radio frequency signal to the inner wall tissue of the left atrial appendage.
  • the ablation element 50 and the electrode 300 can be used to transmit different radio frequency energy or microwave energy respectively, or the ablation element 50 and the electrode 300 can respectively transmit any one of pulse energy, microwave energy or pulse energy.
  • the entire second skeleton 21 of the blocking portion 20 is used to transmit ablation energy for circular ablation, or to collect tissue physiological signals for mapping.
  • the blocking part 20 can completely block the entrance of the left atrial appendage, block the thrombus inside the left atrial appendage, and effectively prevent the thrombus from entering the left atrium.
  • the blocking part 20 can also ablate the inner wall tissue of the entrance of the left atrial appendage well, and has a good ablation effect.
  • the tissue at the mouth of the left atrial appendage is more regular than the internal tissue of the left atrial appendage, and the surface is smooth. Ablation of the mouth of the left atrial appendage is more conducive to the formation of a complete ablation zone at the mouth of the left atrial appendage. Electrically isolated from the left atrium.
  • the anchoring portion 10 and the blocking portion 20 are insulated from each other.
  • the supporting frame 101 further includes insulating connectors 40 .
  • the anchoring part 10 and the blocking part 20 are connected and electrically isolated by the insulating connector 40 to avoid a short circuit between the ablation part 50 and the electrode 300 .
  • the insulating connector 40 is disposed between the anchoring portion 10 and the blocking portion 20 to insulate the anchoring portion 10 from the blocking portion 20 .
  • the insulating connecting member 40 may be omitted, and an insulating section is provided at the connection between the anchoring part 10 and the blocking part 20 to realize the insulating performance between the two.
  • the first frame 11 is fixedly connected to the second frame 21 , so that the blocking part 20 and the anchoring part 10 are connected together. In this embodiment, the first frame 11 and the second frame 21 are fixedly connected together through an insulating connecting piece 40 .
  • the distal end of the first frame 11 gathers toward the center of the anchoring portion 10 and extends along the central axis of the ablation and occlusion device 100 to form a first connecting portion 111 .
  • the second skeleton 21 gathers at a side close to the anchoring portion 10 and extends along the central axis of the ablation and occlusion device 100 to form a second connecting portion 211 .
  • the first connecting part 111 and the second connecting part 211 are fixed on the insulating connector 40 , so as to realize the fixed connection between the anchoring part 10 and the blocking part 20 .
  • the insulating connector 40 is configured as an insulating bushing.
  • the insulating sleeve is disposed between the first connecting portion 111 and the second connecting portion 211 .
  • the anchoring part 10 is made of a tubular or plate-shaped material with shape memory effect through laser cutting, thereby improving the support of the anchoring part 10, and further improving the anchoring part 10 to anchor the ablation and occlusion device 100 to the left atrial appendage oral reliability.
  • the blocking part 20 is braided with braided wires having a shape memory effect, and the braided wires gather at the side close to the anchoring part 10 to be hinged into one strand and extend outwards to form the second connecting part 211, thereby facilitating sealing.
  • the blocking part 20 covers the mouth of the left atrial appendage to block and isolate the left atrium and the left atrial appendage, preventing thrombus in the left atrial appendage from entering the left atrium and preventing the blocking part 20 from damaging the left atrium.
  • at least part of the insulating connector 40 is made of insulating material, such as an insulating tube.
  • One end of the anchoring part 10 is connected to the far side of the insulating connector 40
  • the blocking part 20 is connected to the proximal side of the insulating connector 40 .
  • both the first connecting portion 111 and the second connecting portion 211 can be braided by using a plurality of braiding wires, and the outer surface of each braiding wire or the whole braided body of the first connecting portion 111 and the second connecting portion 211
  • the insulating coating is provided to further avoid the electrical connection between the anchoring part 10 and the blocking part 20, without improving the weaving method, and simplifying the processing technology.
  • first frame 11 and the second frame 21 can be fixedly connected directly by welding.
  • first skeleton 11 and the second skeleton 21 when both the first skeleton 11 and the second skeleton 21 are made by braiding and heat setting of metal wires, the first skeleton 11 and the second skeleton 21 can be braided integrally, or can be welded or welded separately after braiding. They are fixedly connected together by means of connecting pipes, etc.
  • the part of the second skeleton 21 of the blocking part 20 close to the anchoring part 10 is made by braiding, and the part of the second skeleton 21 of the blocking part 20 away from the anchoring part 10 is made by cutting .
  • the first skeleton 11 has a first through hole 110 extending in the axial direction
  • the second skeleton 21 also has a second through hole 210 extending in the axial direction
  • the insulating connector 40 has a third through hole extending in the axial direction.
  • Through hole 401 When the first frame 11 is fixedly connected to the second frame 21, the first through hole 110 of the first frame 11, the second through hole 210 of the second frame 21, and the third through hole 401 of the insulating connector 40 communicate correspondingly, thereby forming
  • the channel 1001 runs through the opposite ends of the ablation and blocking device 100 in the axial direction.
  • the ablation and blocking device 100 is detachably connected to the delivery device 200 , the channel 1001 communicates with the lumen of the sheath tube 201 .
  • the second frame 21 constituting the blocking portion 20 is disc-shaped, and in the perspective of the drawing shown in FIG. 5 , that is, the plane through which the axis of the support frame 101 passes is in the shape of a trapezoid.
  • the blocking portion 20 includes a proximal disk surface 23 , a distal disk surface 24 , and a waist portion 25 connected between the proximal disk surface 23 and the distal disk surface 24 .
  • the proximal disk surface 23 is disposed on the proximal side of the distal disk surface 24 , both of the proximal disk surface 23 and the distal disk surface 24 are substantially planar, and the radial dimension of the proximal disk surface 23 is larger than that of the distal disk surface 24 .
  • the waist 25 extends between the proximal end and the distal end in a cone shape, and the radial dimension of the proximal end of the waist 25 is smaller than the radial dimension of the distal end of the waist 25 .
  • the waist 25 is used to lean against the tissue of the mouth of the left atrial appendage.
  • the distal part of the second skeleton 21 that is, the portion facing the anchor portion 10 is insulated.
  • the second frame 21 includes an insulating section 27 and an ablation section 28 .
  • the ablation section 28 is disposed on a side of the insulation section 27 away from the first frame 11 .
  • the part of the second frame 21 located in the ablation section 28 is used as the ablation element 50, that is, the part of the second frame 21 located in the ablation section 28 is used to transmit ablation electric energy to the tissue, and its surface is conductive, and no insulation treatment is required .
  • the part other than the ablation section 28 is the insulating section 27, and the surface of the part of the second frame 21 located in the insulating section 27 is not used for tissue ablation and needs to be insulated.
  • the insulating section 27 can improve the insulation performance between the first skeleton 11 constituting the anchoring portion 10 and the second skeleton 21 constituting the blocking portion 20 , and on the other hand, the insulating portion 27 can reduce the size of the blocking portion 20
  • the proportion of the ablation element 50 is reduced, that is, the conductive area of the ablation element 50 is reduced, so that the concentrated ablation energy is convenient for ablation of the tissue, the ablation depth and ablation effect are guaranteed, and the conductive area of the ablation element 50 is too large, the ablation energy is dispersed, and the ablation depth is relatively small.
  • An annular ablation zone that is shallow and does not reach through the wall.
  • the ablation section 28 is a part arranged on the peripheral edge of the blocking part 20, and this part is used to abut against the tissue of the mouth of the left atrial appendage, so as to facilitate the ablation of the tissue of the mouth.
  • the ablation section 28 may be disposed at the waist 25 of the second frame 21 .
  • the ablation section 28 is disposed on the waist 25 and the proximal disc surface 23 of the second framework 21 .
  • the ablation section 28 is arranged on the proximal disk surface 23 of the second framework 21; or, the ablation section 28 is also arranged on a part of the distal disk surface 24, for example, on the side of the distal disk surface 24 near the waist 25. part.
  • the ablation section 28 is arranged on the proximal disc surface 23 and the waist 25 with relatively large radial dimensions of the second frame 21, which not only improves the ablation efficiency, but also increases the distance between the ablation section 28 and the electrode 300. distance, thereby improving the insulation performance between the two.
  • the insulating section 27 is arranged on the distal disk surface 24 of the second frame 21, especially the part of the distal disk surface 24 that is easy to contact the first frame 11, such as the axial projection of the first frame 11 in the second frame 21 overlapping parts.
  • the ablation section 28 is insulated from the first frame 11 through the insulating section 27 , thereby improving the insulation performance between the first frame 11 and the second frame 21 .
  • the second frame 21 is made of braided conductive metal wires.
  • the ablation section 28 is configured as a dense mesh braided structure made of braided wires, wherein the braided wires are metal wires.
  • Each support rod 1010 of the second skeleton 21 in the insulating section 27 is a strand of braided wires combined by a plurality of braided wires, for example, the braided wires are combined by braiding, bonding or fixing with other devices.
  • One bundle, and each strand of braided wire is insulated, which is more convenient than insulating each braided wire.
  • each braided wire in the insulating section 27 may not be insulated, but first combined into one strand, and then an insulating coating or an insulating sleeve is provided on the outer surface of the entire braided body.
  • each braided wire is provided with an insulating coating and then combined into a strand, and an insulating sleeve can be sheathed on the periphery of one strand of braided wire, thereby improving the strength of each of the second skeleton 21 in the insulating section 27. Insulation properties of support rod 1010 .
  • a plurality of braided wires in the insulating section 27 are braided (spliced) into one strand, wherein an insulating sleeve is sheathed on the periphery of each braided wire; Generally, an insulating sleeve is sheathed on the periphery of the whole braided body, so as to realize the insulation performance between the insulating section 27 , the ablation section 28 and the first framework 11 .
  • the ablation section 28 is correspondingly provided with an ablation element, and the part of the second framework 21 located in the ablation section 28 may be insulated or may not be insulated.
  • the manner of the insulation treatment can refer to the detailed description of the insulation treatment performed on the insulation section 27 above, which is not specifically limited here.
  • FIG. 9 is a top view of the ablation and occlusion device 100 in FIG. 2 .
  • the supporting frame 101 is used to be implanted into the opening of the left atrial appendage, and the covering film 102 covers the distal end of the supporting frame 101, and the covering film 102 provides a blood supply in the area other than the position corresponding to the electrode 300.
  • a plurality of micropores 33 pass through, so as to avoid the phenomenon of short circuit caused by electrical conduction between the electrode 300 and the support frame 101 at the micropores 33 .
  • each micropore 33 is less than 0.25mm, thereby restricting the thrombus in the left atrial appendage from flowing out from the ablation and blocking device 100, and making the blood in the left atrial appendage and the left atrium form a normal circulation, and avoiding the loss of the left atrial appendage thrombus Later, as the blood flows to all parts of the body, problems such as cerebral embolism (stroke) and limb arterial embolism are caused.
  • stroke cerebral embolism
  • limb arterial embolism limb arterial embolism
  • FIG. 10 is a schematic structural diagram of a fifth embodiment of the ablation and closure device 100f of the ablation and closure system 1000 in FIG. 1 .
  • the structure of the ablation and closure device 100f in the sixth embodiment is similar to that of the ablation and closure device 100e in FIG. 8A , except that the ablation and closure device 100f further includes an insulating film 106 .
  • the insulating film 106 covers the outer surface of the second frame 21 , thereby improving the insulation performance between the first frame 11 and the second frame 21 .
  • the ablation member 50 is disposed on the proximal side of the blocking portion 20 and is exposed relative to the insulating film 106 , so as to facilitate ablation of the tissue by contacting the tissue.
  • the ablation element 50 is configured in a ring shape to form a ring-shaped ablation zone at the mouth of the left atrial appendage to improve ablation efficiency.
  • the insulating film 106 is disposed on the distal side of the blocking portion 20, that is, the insulating film 106 is disposed on the side of the second frame 21 close to the anchoring portion 10, thereby enhancing the insulation between the anchoring portion 10 and the blocking portion 20 , preventing the first frame 11 from contacting the distal end of the second frame 21 and causing the short circuit between the ablation element 50 and the first frame 11 and the electrode 300, ensuring the safety and reliability of the ablation and sealing device 100f, and the insulating film 106 is used to seal the Part of the second framework 21 that is not used as the ablation element 50 in the blocking portion 20 is insulated on the surface, which reduces the proportion of the ablation element 50 in the blocking portion 20, that is, reduces the surface area of the ablation element 50, which is conducive to concentrating the ablation energy In a smaller ablation range, the ablation energy is concentrated, which ensures the ablation depth and ablation effect.
  • the insulating film 106 may also be disposed on the distal side and the proximal side of the blocking portion 20 .
  • the ablation element 50 can be arranged on the insulating film 106, and the ablation element 50 and the first frame 11 are spaced apart, so as to avoid the phenomenon of short circuit caused by the electrical conduction between the ablation element 50 and the first frame 11, and ensure The ablation effect of the ablation and occlusion device 100f.
  • FIG. 11 is a schematic structural view of the sixth embodiment of the ablation and occlusion device 100g of the ablation and occlusion system 1000 in FIG. 1 ;
  • FIG. 12 is the ablation and occlusion device in FIG. 11
  • the structure of the ablation and occlusion device 100g in the sixth embodiment is similar to that of the ablation and occlusion device 100e in the fourth embodiment, the difference is that the support frame 101 is configured as a single disc structure, which is in the shape of a plunger.
  • the profile of the supporting frame 101 may be a truncated cone whose diameter gradually decreases from the proximal end to the distal end.
  • the outline of the support frame 101 may also be disc-shaped, cylindrical, etc.
  • the profile of the supporting frame 101 is a truncated cone, and the maximum diameter is larger than the diameter of the opening of the left atrial appendage.
  • the peripheral surface of the supporting frame 101 is a conical surface.
  • the distal end of the support frame 101 enters the left atrial appendage, and the largest diameter of the support frame 101 is blocked on the side of the opening of the left atrial appendage adjacent to the left atrium, and the myocardial tissue at the mouth of the left atrial appendage Attached to the tapered surface around the circumference of the support frame 101 .
  • the support frame 101 includes a distal section 1011 and a proximal section 1012 spaced apart from the distal section 1011 .
  • the distal section 1011 is formed in the anchoring portion 10
  • the proximal section 1012 is formed in the blocking portion 20 .
  • the electrode 300 is set corresponding to the distal section 1011
  • the ablation element 50 is set corresponding to the proximal section 1012 .
  • the distal section 1011 is used as a bearing section or an insulating section, that is, the surface of the supporting frame 101 corresponding to the distal section 1011 is provided with an insulating coating or an insulating sleeve.
  • the proximal section 1012 is used as the ablation section, that is, the part of the support framework 101 corresponding to the proximal section 1012 is used as the ablation element 50, that is, the part of the second framework 21 located in the proximal section 1012 can conduct electricity and is used for Delivers ablation electrical energy to tissue.
  • the proximal section 1012 of the second frame 21 is additionally provided with an ablation element 50 independent of the second frame 21 .
  • the distal section 1011 is used as a load-bearing section, that is, the part of the first frame 11 located in the distal section 1011 is insulated. All parts are insulated, so as to ensure the insulation performance between the electrode 300 and the ablation element 50, thereby improving the safety and stability of the ablation and closure system 1000 in use.
  • the distal section 1011 and the proximal section 1012 may both function as load-bearing sections or insulating sections.
  • the support skeleton 101 further includes an insulating section 1013 between the distal section 1011 and the proximal section 1012 .
  • the insulating section 1013 is made of insulating material
  • the part of the first skeleton 11 located in the distal section 1011 is made of metal, and is connected with the skeleton in the insulating section 1013 by fusion
  • the second skeleton 21 located in the proximal section The part in 1012 is made of metal material, and is connected with the skeleton in the insulating section 1013 by fusion.
  • the part of the first frame 11 located in the distal section 1011 and the part of the second frame 21 located in the proximal section 1012 are integrally made of the same material.
  • the parts of the support frame 101 at the insulating section 1013 and the distal section 1011 are made of insulating materials, so that the surface of the distal section 1011 does not need to be insulated.
  • the covering film 102 covers the distal end of the first framework 11 .
  • the covering film 102 covers the entire outer surface of the anchoring portion 10 , and the blocking portion 20 is exposed relative to the covering film 102 .
  • the distal part of the second frame 21 constituting the blocking portion 20 is insulated, so as to enhance the insulation performance between the supporting frame 101 , the electrode 300 and the ablation element 50 .
  • the manner of the insulation treatment can refer to the detailed description of the above-mentioned insulation treatment of the ablation section, and no specific limitation is made here.
  • Fig. 13 is a schematic structural diagram of the second embodiment of the ablation and closure system 1000a in Fig. 1;
  • Fig. 14 is a partial structure of the ablation and closure system 1000a in Fig. 13 Schematic.
  • the structure of the ablation and closure system 1000 a in the second embodiment is similar to that of the ablation and closure system 1000 in the first embodiment, except that the electrode 300 is fixed on the delivery device 200 .
  • the delivery device 200 further includes an active catheter 60 .
  • a channel 1001 is provided axially on the support frame 101, and the movable catheter 60 is movably passed through the channel 1001.
  • the movable catheter 60 includes a catheter body 61, and the electrode 300a is arranged at the distal end of the catheter body 61.
  • the distal end of the movable catheter 60 is end for release on the distal side of the support frame 101.
  • the catheter body 61 is provided with a plurality of electrodes 300a arranged at intervals, so as to realize the ablation treatment of the tissue to be ablated.
  • the movable catheter 60 is in a tubular structure as a whole.
  • the electrode 300a is sealed and connected to the catheter body 61 to prevent blood or other body fluids from entering the catheter body 61 when the movable catheter 60 works in the human body, thereby ensuring the stability of the electrode 300a.
  • the connection between the electrode 300a and the catheter body 61 is fixed and sealed by glue.
  • the active catheter 60 includes a tubular catheter body 61 and a plurality of tubular or ring-shaped electrodes 300 a disposed on the catheter body 61 at intervals.
  • the tubular or annular electrode 300a is sheathed outside the catheter body 61, and the outer surface of the tubular or annular electrode 300a is in contact with the outer peripheral surface of the catheter body 61 to form a flat surface, thereby improving the smoothness of the movable catheter 60. sex.
  • the electrode 300a can also be in the shape of a point, a hemispherical structure, a blunt protrusion structure or a smooth protrusion structure, thereby increasing the contact surface between the electrode 300a and the target tissue area, thereby improving ablation effectiveness.
  • the material of the electrode 300a may include but not limited to at least one of high-conductivity materials such as platinum-iridium alloy, pure gold, and silver.
  • the proximal end of the catheter body 61 passes through the lumen of the sheath 201 and is connected to the control handle 202 .
  • the catheter body 61 includes an adjustable bend section 611 at the distal end of the catheter body 61 and a main body section 612 at the proximal end of the catheter body 61 .
  • the adjustable bend section 611 is fixedly connected to the distal end of the main body section 612 .
  • the hardness of the adjustable curved section 611 is less than or equal to that of the main body section 612, so that the main body section 612 can support the adjustable curved section 611, thereby facilitating the transportation of the catheter body 61 to the target tissue.
  • the catheter body 61 is made of a polymer material, and the polymer material includes but is not limited to polyamide (Polyamide, PA), polyether block amide (Polyether block amide, Pebax), nylon, thermoplastic polyurethane elastomer (Thermoplastic urethane, At least one of Tpu) and the like.
  • a plurality of electrodes 300a are disposed on the adjustable bend section 611 of the catheter body 61, so as to perform ablation on different ablated tissue regions.
  • the catheter body 61 further includes a transition section 613 connecting the adjustable bend section 611 and the main section 612 .
  • the main body section 612 , the adjustable bend section 611 and the transition section 613 are sequentially connected from the proximal end to the distal end of the catheter body 61 .
  • the adjustable bend section 611 and the main body section 612 are connected smoothly through a transition section 613 .
  • the sheath tube 201 includes an inner tube 2011 and an outer tube 2012 arranged coaxially, and the inner tube 2011 is passed through the lumen of the outer tube 2012 .
  • the movable catheter 60 is completely accommodated in the inner tube 2011 .
  • the adjustable bend section 611 of the catheter body 61 is configured as a ring structure.
  • the adjustable bend section 611 of the catheter body 61 extends radially outward from the distal end of the body section 612 .
  • the adjustable bend section 611 extends in a ring shape around the circumference of the main section 612 from the end of the transition section 613 away from the main section 612 .
  • a plurality of electrodes 300 a are arranged at intervals on the transition section 613 and the adjustable bending section 611 .
  • the adjustable bend section 611 wraps around the body section 612 in a helical shape as a whole. It can surround the body section 612 in a planar spiral structure, or gradually spiral around the body section 612 in a columnar or cylindrical shape. conical.
  • the shape of the adjustable curved section 611 is designed according to the ablation site of the tissue to be ablated, which is not specifically limited in this application.
  • adjacent electrodes 300a can transmit the same ablation electric energy; they can also transmit different ablation electric energy, for example, transmit pulse ablation electric energy with different polarities.
  • the plurality of electrodes 300a includes a plurality of positive electrodes 301a and a plurality of negative electrodes 302a.
  • the number of positive electrodes 301a and negative electrodes 302a each includes a plurality.
  • a plurality of positive electrodes 301a and a plurality of negative electrodes 302a are arranged alternately along the extending direction of the catheter body 61 and are spaced apart from each other, so that when the plurality of positive electrodes 301a and the plurality of negative electrodes 302a are discharged, a plurality of pulsed electric fields can be formed to form
  • the ring-shaped ablation area improves the effect and efficiency of ablation treatment on the target tissue area.
  • a plurality of positive electrodes 301a and a plurality of negative electrodes 302a may be alternately arranged in such a way that the electrodes with even numbers counted from the proximal end to the distal end along the extending direction of the catheter body 61 are positive electrodes 301a, and the electrodes with odd numbers are negative electrodes 301a. electrode 302a, or vice versa.
  • the energy generating device transmits ablation energy to multiple positive electrodes 301a and multiple negative electrodes 302a
  • the electrodes 300a that are discharged at the same time can be more evenly distributed along the extending direction of the catheter body 61, thereby facilitating simultaneous injection of ablation energy to the target tissue area.
  • the ablation energy is transmitted evenly in multiple places to improve the ablation effect.
  • the active catheter 60 can also be used to collect electrophysiological signals inside the left atrial appendage, and correspondingly, the electrodes 300a can be used for mapping.
  • the electrode 300a is electrically connected to an external mapping device, and senses the physiological activity of the tissue to be ablated at the ablation site, thereby judging whether the ablation site has tissue to be ablated that needs to be ablated, thereby performing more targeted ablation of the tissue to be ablated , thereby improving the ablation effect, thereby improving the therapeutic effect of the operation, and providing a more accurate basis for the accurate positioning of the operation.
  • some of the plurality of electrodes 300a are used for ablation, and some are used for mapping.
  • the plurality of electrodes 300a are only used to realize the mapping function, and are not used to realize the ablation function.
  • the adjustable bending section 611 is a pre-bending section, that is, the adjustable bending section 611 is flexible, and it is pre-shaped as a ring, which is annular in the natural state. In the delivery state, the adjustable bending section 611 It is in the shape of a straight rod under the constraints of the inner tube, and the adjustable curved section 611 returns to a ring shape after being released from the inner tube.
  • the adjustable curved section 611 is in the shape of a ring, which facilitates a plurality of electrodes 300 a in the adjustable curved section to abut against the inner wall of the left atrial appendage tissue, and facilitates ablation and mapping of the electrodes 300 a.
  • an adjusting member for adjusting the degree of curvature of the adjustable bending section 611 is disposed in the catheter body 61 .
  • the adjustment part can be pre-shaped, so that the adjustable curved section 611 follows the shape of the adjustment part after the distal end side of the support frame is released and deforms into a preset shape, such as but not limited to a ring shape, a U shape, a C shape wait.
  • a plurality of positive electrodes 301a and a plurality of negative electrodes 302a are arranged at equal intervals, so that the formed ablation electric field is relatively uniform, and the ablation depth is basically the same; Electrophysiological signals are collected from a circle of positions, which avoids the problem that local positions are not mapped.
  • the plurality of electrodes 300a are designed at equal intervals, which also balances the overall force of the catheter body 61 , thereby promoting the deformation of the distal end of the catheter body 61 following the preset shape corresponding to the adjustment member.
  • the supporting frame 101 can be configured as a split double disc structure, that is, the anchoring part 10 and the blocking part 20 are respectively configured to form a disc-shaped structure, and are connected by connectors; in some embodiments, the supporting frame 101 can be configured as shown in Figure 12 A single disk structure in an embodiment.
  • the electrode 300a provided on the catheter body 61 is insulated from the support frame 101 by the coating 102, so as to avoid the problem that the electrode 300 is electrically connected to the support frame 101 in the energized state, and the support frame 101 damages the tissue to be ablated.
  • the covering film 102 covers the distal end of the support frame 101 .
  • the covering film 102 covers the entire outer surface of the anchoring portion 10 .
  • the covering film 102 covers part of the outer surface of the anchoring part 10 .
  • a developing positioning member is provided on the catheter body 61 to further improve the positioning effect on the distal end of the catheter body 61 .
  • the material of the developing structure includes but not limited to at least one of tantalum alloy, platinum-iridium alloy, platinum-tungsten alloy, and gold.
  • the ablation and closure system 1000a further includes the ablation element 50 set on the support frame 101 and used for ablation of the tissue to be ablated as described in the above embodiments.
  • the ablation element 50 is in the form of a ring or surrounds a ring.
  • the ablation element 50 is disposed on the support frame 101 at a position not covered by the membrane 102 .
  • the ablation element 50 is disposed on the blocking portion 20 .
  • the ablation element 50 is disposed on at least one of the proximal disk surface 23 , the distal disk surface 24 and the waist portion 25 of the second skeleton 21 constituting the blocking portion 20 .
  • the ablation and closure system 1000a further includes an insulating coating covering the outer surface of the second skeleton 21, and the insulating coating is disposed on the distal side of the blocking part 20 close to the anchoring part 10 to strengthen the second frame. Insulation performance between the first frame 11 and the second frame 21 and the ablation element 50 .
  • the ablation element 50 is disposed on the support frame 101 at a position not covered by the insulating film. Specifically, the ablation element 50 is disposed on the peripheral edge of the second frame 21 and exposed relative to the insulating film 106 .
  • the ablation element 50 may be a conductive element additionally provided on the support frame 101 , or be a part of the support frame 101 .
  • the ablation element 50 is disposed on the outer side of the covering membrane 102 away from the support frame 101 .
  • the ablation element 50 is disposed on the anchoring portion 10 , and the coating 102 covers the outer surface of the first framework 11 constituting the anchoring portion 10 .
  • there are multiple ablation elements 50 which are respectively arranged on the anchoring part 10 and the blocking part 20 .
  • the surface of the support frame 101 corresponding to the ablation element 50 is subjected to insulation treatment.
  • insulation treatment please refer to the specific description of the foregoing embodiments, which will not be repeated here.
  • first frame 11 constituting the anchoring portion 10 and the second frame 21 constituting the blocking portion 20 are integrally formed to simplify the manufacturing process.
  • Electrodes 300 and the ablation element 50 may or may not work simultaneously. Both electrodes 300 and ablation element 50 can be used to ablate tissue or map electrophysiological signals.
  • the movable catheter 60 in the embodiment shown in FIGS. 13-14 can also be applied to the ablation and occlusion device 100 shown in FIG. 2 and the ablation and occlusion device 100g shown in FIG. 11 .
  • FIG. 15 is a schematic structural diagram of a third embodiment of the ablation and closure system 1000 b in FIG. 1 .
  • the ablation and closure device 100 includes a support frame 101 and a membrane 102
  • the delivery device 200 includes a movable catheter 60 .
  • the distal end of the movable catheter 60 is provided with an electrode 300a, and the electrode 300a is used for tissue ablation or electrophysiological signal mapping.
  • the distal end of the movable catheter 60 can pass through the channel formed by the supporting frame 101 and can protrude from the distal end of the supporting frame 101 to be close to the tissue.
  • the electrode 300a can be attached to the surface of the tissue.
  • the distal end of the active catheter 60 can move from the channel of the supporting frame 101 to the proximal end, and be withdrawn from the body.
  • the support frame 101 is made of metal material.
  • the coating 102 is arranged outside the support frame 101, that is, the coating 102 is sandwiched between the support frame 101 and the electrode 300a.
  • the ablation and blocking device 100 is provided with an ablation element 50 , and the ablation element 50 includes a first ablation element 51 and a second ablation element 52 .
  • the first ablation element 51 and the second ablation element 52 are arranged at intervals.
  • a pulse ablation electric field can be generated between the first ablation element 51 and the second ablation element 52, and the myocardial tissue within a certain range of electric field strength will be ablated by the pulse energy, thereby realizing irreversible electroporation, thereby improving the ablation of the ablation and blocking device 100e Effect.
  • the first ablation element 51 is disposed on the anchoring part 10 . Specifically, the first ablation element 51 is disposed on the side of the covering membrane 102 away from the first support frame 11 . Specifically, the first ablation element 51 is fixed on the outer side of the membrane 102, and is spaced apart from the electrode 300a.
  • the first ablation element 51 may be a conductive element fixedly arranged on the outer surface of the membrane 102 , such as a wire electrode. As described in the above embodiment, the wire electrode has a corrugated shape.
  • the first ablation element 51 can also be, but not limited to, point-shaped electrodes, sheet-shaped electrodes, and the like.
  • the first ablation element 51 and the electrode 300a are used to transmit the same or different ablation electric energy. It can be understood that, in this embodiment, the first ablation element 51 is in the form of a conductive element, that is, the first ablation element 51 and the electrode 300 a are both disposed on the side of the membrane 102 away from the support frame 101
  • the first ablation element 51 is a part of the supporting frame, such as part of the first frame and/or the second frame, and the first ablation element 51 is disposed at a position where the supporting frame 101 is not covered by the membrane 102 .
  • the second ablation element 52 is a conductive element disposed on the support frame 101 , such as disposed on the first frame and/or the second frame.
  • the second ablation element 52 is disposed on the blocking portion 20 . Specifically, the second ablation element 52 is disposed in the ablation section 28 of the second skeleton 21 .
  • the second ablation element 52 may be a part of the second frame 21 located in the ablation section 28 ; or, it may also be a conductive element independent of the second frame 21 .
  • the second ablation element 52 may also be disposed on the insulating section 27 and spaced apart from the first frame 11 and the first ablation element 51 .
  • the first ablation element, the second ablation element and the electrode 300a are used to transmit the same or different ablation electric energy.
  • the ablation and closure device 100 is only provided with the first ablation element 51 , and the first ablation element 51 is disposed on the side of the covering membrane 102 away from the support frame 101 .
  • the first ablation element 51 is disposed on the anchoring portion 10 and fixed on the outer surface of the membrane 102 .
  • the first ablation element 51 and the electrode 300a are spaced apart from each other.
  • the first ablation element 51 is a wire-shaped electrode fixedly arranged on the outer surface of the membrane 102 .
  • the wire-shaped electrode is in a corrugated shape.
  • the first ablation element 51 and the electrode 300a are used to transmit the same or different ablation electric energy.
  • the ablation and closure device 100 is only provided with the second ablation element 52 , and the second ablation element 52 is disposed in the ablation section 28 of the second frame 21 .
  • the first ablation element, the second ablation element and the electrode 300a can be used to transmit ablation electric energy and/or collect electrophysiological signals of tissues respectively.
  • the coating is placed between the supporting frame and the electrode, so that the electrode is insulated from the supporting frame through the coating, so that during the ablation process of the tissue to be ablated with the electrode, the electric energy of the electrode will not be transmitted to the supporting frame, Therefore, it is possible to avoid the phenomenon of short circuit caused by direct electrical conduction between the electrode and the support frame, thereby ensuring the safety, stability and ablation effect of the electrode ablation of the ablation and closure system.
  • the coating can also prevent the thrombus in the left atrial appendage from flowing out, so as to avoid problems such as cerebral embolism (stroke) and limb arterial embolism caused by the thrombus in the left atrial appendage falling off and flowing to all parts of the body with blood.
  • the coating can be directly formed on the anchoring disc skeleton by dipping or coating to obtain a coating with relatively small porosity, thereby further enhancing the reliability and stability of the insulation between the supporting skeleton and the electrode .
  • the film is provided with a plurality of micropores for the passage of blood in the area other than the corresponding electrode position, so as to avoid the phenomenon of short circuit caused by electrical conduction between the electrodes and the supporting frame at the micropores.
  • the micropores can restrict the thrombus in the left atrial appendage from flowing out of the ablation and occlusion device, so that the blood in the left atrial appendage and the left atrium can form a normal circulation, and prevent the thrombus from the left atrial appendage from falling off as the blood flows to all parts of the body.
  • stroke cerebral embolism
  • limb arterial embolism and other problems.

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Abstract

消融封堵系统(1000、1000a、1000b)包括输送装置(200)、消融封堵装置(100、100a、100c、100e、100g、100h)及电极(300a)。电极(300a)与输送装置(200)的远端连接。消融封堵装置(100、100a、100c、100e、100g、100h)包括支撑骨架(101)和覆膜(102)。支撑骨架(101)由导电材料制成。覆膜(102)包覆于支撑骨架(101)外。电极(300a)设置于输送装置(200)和/或消融封堵装置(100、100a、100c、100e、100g、100h)上，且位于覆膜(102)背离支撑骨架(101)的一侧，电极(300a)通过覆膜(102)与支撑骨架(101)绝缘设置，电极(300a)用于对待消融组织进行消融，从而能够避免支撑骨架(101)与电极(300a)直接电导通而发生短路的现象，消融的安全性、稳定性以及消融效果。

Description

消融封堵系统
本申请要求于2021年12月31日提交中国专利局、申请号为202111665434.X、申请名称为“消融封堵系统”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
本申请涉及医疗器械技术领域，尤其涉及一种消融封堵系统。
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％。房颤患病率还与冠心病、高血压病和心力衰竭等疾病有密切关系。左心耳因其特殊形态及结构不仅为房颤血栓形成最主要的部位，也是其发生和维持的关键区域之一，部分房颤患者可经主动左心耳电隔离)获益。
“射频消融+左心耳封堵”一站式治疗是当今房颤的治疗热点之一。目前，采用联合导管射频消融和左心耳封堵的一站式治疗方法，已经取得了很多成功治疗房颤的案例。一站式治疗方法中，通过左心耳封堵术，患者在不需终身服用抗凝药物的情况下仍能获得良好的卒中预防效果；再结合导管射频消融恢复并维持窦律进而改善房颤患者症状，可使患者获得稳定的远期治疗效果。但是目前采用的消融方式主要是：通过肺静脉电隔离(PVI)加消融肺静脉以外的“房颤灶”，不增加左心耳电隔离(除非来自左心耳的触发灶能导致持续房颤、房扑或房速)。采用这种消融方法，患者1年后的房颤复发率较高。
有研究表明，对于长程持续性房颤患者，进行左心耳电隔离可以减少术后房颤复发，且不增加手术并发症。
然而，目前用于治疗房颤的活动导管都是针对肺静脉消融所设计，由于不同患者的左心耳开口大小、深浅，以及左心耳位置存在较大差异性，现有的肺静脉活动导管明显不适用于左心耳消融。并且，若要在上述一站式治疗的过程中对左心耳进行消融术和封堵术，需要以介入方式引入活动导管与左心耳消融封堵装置，关键是要将两个设备先后定位在左心耳口部位置，再分别实行消融与封堵，由于活动导管以及左心耳封堵在左心耳口部定位难度均较大，导致手术程序复杂，耗时长，不利于提高“消融+左心耳封堵”一站式治疗手术的便捷性。此外，现有的消融封堵装置的支撑骨架与电极直接电导通而容易产生电火花导致对组织的损伤。
发明内容
有鉴于此，本申请提供一种消融封堵系统，以解决现有的消融封堵装置的支撑骨架与电极直接电导通而容易产生电火花导致对组织的损伤问题。
本申请实施例提供一种消融封堵装置，包括：
输送装置；
消融封堵装置，所述消融封堵装置与所述输送装置的远端连接；所述消融封堵装置包括：
支撑骨架，所述支撑骨架由导电材料制成；以及
覆膜，所述覆膜包覆于所述支撑骨架外；以及
电极，所述电极设置于所述输送装置和/或所述消融封堵装置上，且位于所述覆膜背离所述支撑骨架的一侧，所述电极通过所述覆膜与所述支撑骨架绝缘设置，所述电极用于对待消融组织进行消融。
本申请实施例提供的消融封堵系统，包括输送装置、消融封堵装置及电极。消融封堵装置包括支撑骨架和覆膜。基于将覆膜设置于支撑骨架和电极之间，以使得电极通过覆膜与支撑骨架绝缘设置，因此在采用电极对待消融组织进行消融的过程中，电极的电能不会传输至支撑骨架，即能够避免电极与支撑骨架电性耦合，导致支撑骨架导电，而发生消融面积扩大，消融深度较浅的问题发生，进而确保消融封堵系统的电极消融的安全性、稳定性以及消融效果。此外，覆膜还能够阻止左心耳内的血栓流出，从而避免左心耳内的血栓脱落后随着血液流至全身各处而导致脑栓塞(脑卒中)、肢体动脉栓塞等问题。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，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它的附图。
图1是本申请实施例提供的消融封堵系统的结构示意图。
图2是图1中的消融封堵系统的消融封堵装置的第一实施方式的结构示意图。
图3是图1中的消融封堵系统的消融封堵装置的第二实施方式的结构示意图。
图4A是图2以及图3中的消融封堵装置的覆膜的扫描电镜图。
图4B是现有的覆膜的扫描电镜图。
图5是图2中的消融封堵装置的支撑骨架以及电极结构示意图。
图6是图5中的消融封堵装置的支撑骨架设置绝缘涂层的结构示意图。
图7是图1中的消融封堵系统的消融封堵装置的第三实施方式的结构示意图。
图8A是图1中的消融封堵系统的消融封堵装置的第四实施方式的结构示意图。
图8B是图8A提供的消融封堵装置的另一角度的结构示意图。
图9是图2中的消融封堵系统的消融封堵装置的俯视图。
图10是图1中的消融封堵系统的消融封堵装置的第五实施方式的结构示意图。
图11是图1中的消融封堵系统的消融封堵装置的第六实施方式的结构示意图。
图12是图11中的消融封堵系统的消融封堵装置的支撑骨架以及电极的结构示意图。
图13是图1中的消融封堵系统的第二实施方式的结构示意图。
图14是图13中的消融封堵系统的部分结构的结构示意图。
图15是图1中的消融封堵系统的第三实施方式的部分结构示意图。
主要元件符号说明
消融封堵系统                             1000、1000a、1000b
消融封堵装置                             100、100a、100c、100e、100g、100h
支撑骨架                                 101
第一支杆                                 1010a
第二支杆                                 1010b
远侧区段                                 1011
近侧区段                                 1012
绝缘区段                                 1013
锚定部                                   10
第一骨架                                 11
第一通孔                                 110
第一连接部                               111
收容槽                                   112
锚刺                                     13
封堵部                                   20
近端盘面                                 23
远端盘面                                 24
腰部                                     25
绝缘区段                                 27
消融区段                                 28
第二骨架                                 21
第二通孔                                 210
第二连接部                               211
覆膜                                     102
绝缘膜                                   106
微孔                                     33
缝合点                                   103
承载区段                                 104
绝缘涂层                                 105
绝缘连接件                               40
第三通孔                                 401
通道                                     1001
电极                                     300
连接点                                   301
连杆                                     302
消融件                                   50
第一消融件                               51
第二消融件                               52
输送装置                                 200
鞘管                                     201
内管                                     2011
外管                                     2012
控制手柄                                 202
活动导管                                 60
导管本体                                 61
可调弯段                                 611
主体段                                   612
过渡段                                   613
电极                                     300a
正电极                                   301a
负电极                                   302a
如下具体实施方式将结合上述附图进一步说明本申请。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本申请保护的范围。
首先需要说明的是，在介入医疗领域，通常将医疗器械靠近操作者的一端称作近端(也即操作端)，将医疗器械远离操作者的一端称作远端(也即插入端)。具体的，远端是指医疗器械可自由插入到动物或人体体内的一端。近端是指供用户或机器操作的一端或是用于连接其它器件的一端。换言之，该左心耳封堵消融装置植入左心耳处后，左心耳封堵消融装置中某部件的近端为该部件靠近左心房的一端，某部件的远端为该部件靠近左心耳的一端。左心耳口部是指从左心房进入左心耳的位置。
本申请实施例提供的消融封堵装置为左心耳消融封堵装置，用于植入至左心耳口部，并能够对左心耳组织进行电消融，比如脉冲消融、射频消融或微波消融。其中，脉冲消融利用高强度的脉冲电场使细胞膜发生不可逆电击穿，在医学领域称之为不可逆电穿孔(Irreversible electroporation，IRE)，使细胞凋亡从而实现非热效应消融细胞，所以不受热沉效应影响。高电压脉冲序列产热少，不需要生理盐水冲洗来冷却，可有效减少气爆、焦痂和血栓的发生。脉冲消融治疗时间短，施加一组脉冲序列的治疗时间不到1分钟，全程消融时间一般不超过5分钟。且由于不同组织对脉冲电场的反应阈值存在差异，为消融心肌而不干扰其他邻近组织提供了可能，从而可避免误伤左心耳邻近的组织。另外，相较于其他能量，脉冲消融不需要热传导来对深层组织消融，所有分布在一定电场强度之上的心肌细胞均会发生电穿孔，降低了消融时对导管贴靠压力的要求。因此即使消融器械在进入左心耳内后没有完全地贴合左心耳内壁，也不影响IRE消融效果。施放脉冲能量的电极也可以采集心内电信号，在消融前，采集心内心电信号传递至心电同步仪，使脉冲输出同步在心肌收缩的绝对不应期，从而不干扰心率，减少突发心律失常；在消融操作后，也可通过心内信号判断是否对组织完全电隔离。
可以理解，本申请的说明书和权利要求书及上述附图中的术语仅是为了描述特定实施例，并非要限制本申请。本申请的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别不同对象，而非用于描述特定顺序。除非上下文另有明确表述，否则单数形式“一”和“所述”也旨在包括复数形式。术语“包括”以及它们任何变形，意图在于覆盖不排他的包含。此外，本申请可以以多种不同的形式来实现，并不限于本实施例所描述的实施例。提供以下具体实施例的目的是便于对本申请公开内容更清楚透彻的理解，其中上、下、左、右、内、外等指示方位的字词仅是针对所示结构在对应附图中位置而言。
说明书后续描述为实施本申请的较佳实施例，然上述描述乃以说明本申请的一般原则为目的，并非用以限定本申请的范围。本申请的保护范围当视所附权利要求所界定者为准。
消融封堵系统1000是一种经皮介入人体并且对封堵组织中的缺损进行封堵及对待消融组织进行消融的设备，以达到治疗疾病(例如，心房颤动等)的目的。所述封堵组织包括但不局限于左心耳、卵圆孔、动脉导管、房间隔、室间隔等。需要说明的是，本申请中以封堵组织为左心耳为例，说明消融封堵系统1000 用于治疗左心耳的优势。可以理解的是，封堵组织还可以是上述提到的其它组织。
请参阅图1，图1所示为本申请实施例提供的消融封堵系统1000的结构示意图。消融封堵系统1000包括消融封堵装置100和输送装置200及电极300。消融封堵装置100与输送装置200的远端连接。输送装置200用于将消融封堵装置100输送至封堵组织处，例如左心耳。消融封堵装置100包括支撑骨架101和覆膜102。支撑骨架101由导电材料制成。覆膜102包覆于支撑骨架101外。在一些实施例中，电极300可以设置于消融封堵装置100上。在其它一些实施例中，电极300还可以设置于输送装置200上。电极300位于覆膜102背离支撑骨架101的一侧。电极300通过覆膜102与支撑骨架101绝缘设置。电极300用于对待消融组织进行消融。如此，在使用消融封堵装置100的过程中，电极300的电能不会传输至支撑骨架101，即能够避免电极300与支撑骨架101电性耦合，导致支撑骨架101导电，而发生消融面积扩大及消融深度较浅的问题；从而能够避免电极300与支撑骨架101之间发生短路的现象，进而确保消融封堵装置100消融的安全性、稳定性以及消融效果。此外，覆膜102还能够阻止左心耳内的血栓流出，从而避免左心耳内的血栓脱落后随着血液流至全身各处而导致脑栓塞(脑卒中)、肢体动脉栓塞等问题。
在本实施例中，输送装置200包括用于收容消融封堵装置100的鞘管201及固定于鞘管201近端的控制手柄202。控制手柄202用于控制消融封堵装置100从鞘管201的远端伸出，并且释放至封堵组织(左心耳口部)处；或者，用于控制消融封堵装置100回收至鞘管201内。控制手柄202还用于控制鞘管201在血管中前进、后撤以及旋转，以及控制电极300的消融过程。
本领技术人员应当理解的是，所述图1仅是消融封堵系统1000的示例，并不构成对消融封堵系统1000的限定，且消融封堵系统1000可以包括比图1所示更多或更少的部件，或者组合某些部件，或者不同的部件，例如消融封堵系统1000还可以包括温度传感器、显影定位件等。温度传感器用于检测目标组织在消融过程中的温度，以防止温度过低或过高。
在本实施例中，电极300可以作为消融电极，以实现对待消融组织区域进行消融。当电极300用于实现消融功能时，电极300外接能量发生装置。其中，能量发生装置用于在消融过程中向消融封堵装置100的电极300提供消融能量，以使得电极300向待消融组织区域传递消融能量进行消融。能量发生装置能够根据待消融组织区域的待消融组织所需的消融参数输出相应的消融能量。消融能量包括但不局限于射频能量、微波能量、脉冲能量等中的至少一种。能量发生装置，例如是，但不局限于射频发生器、微波理疗仪、脉冲发生器中的一者或它们之间的任意组合。
在一些实施例中，电极300还可以作为标测电极，以实现标测功能。当电极300用于实现标测功能时，电极300连接外部标测设备(图未示)，并将采集到的待消融组织区域的电生理信号传递至外部标测设备。具体地，电极300与外部标测设备电性连接，感测消融位点的待消融组织的生理活动，从而判断消融位点是否具有需要消融的待消融组织，从而更针对地对待消融组织进行消融，从而提高了消融效果，进而改善手术的治疗效果，以及对手术的准确定位提供更确切的依据。
在一些实施方式中，电极300的数量可以包括多个，多个电极300间隔设置，其中部分电极300用于电连接能量发生装置，以实现消融功能，部分电极300用于电连接外部标测设备，以实现标测功能。在其它一些实施例中，电极300的数量还可以包括一个。
在一些实施方式中，每个电极300可选择地用于实现消融功能或标测功能。
在一些实施方式中，电极300仅仅用于实现消融功能或标测功能。
消融封堵装置100为自膨胀式的支架。例如，消融封堵装置100可以是弹性的金属支架。在本实施例中，消融封堵装置100为镍钛合金支架。当消融封堵装置100通过输送装置200输送时，消融封堵装置100的径向尺寸收缩至较小状态以便于在鞘管201中输送；当消融封堵装置100输送至左心耳口部释放后，消融封堵装置100可自动膨胀至预定形状尺寸以支撑于左心耳口部的内壁上，消融封堵装置100对左心耳的内壁产生径向的支撑作用，从而固定于左心耳口部。
需要说明的是，图1至图15中消融封堵装置100的消融封堵装置100及电极300均呈自由扩张状态，即消融封堵装置100从鞘管201的远端释放后未植入至左心耳口部的状态。消融封堵装置100植入至左心耳口部之后，消融封堵装置100容易因为适形于不同形态的左心耳从而导致消融封堵装置100变形。
覆膜102固定于支撑骨架101上。在一些实施例中，覆膜102可以通过浸渍方式、溶液浇铸方式、喷涂方式、流延成型方式、模压成型方式或注塑成型方式，从而覆膜102的孔隙率相对较小，进而增强了覆膜102的绝缘性能。成型后的覆膜102通过缝合方式、热压方式或粘接方式固定于支撑骨架101上，从而覆膜102能够贴接于支撑骨架101的外表面，以减少在支撑骨架101与覆膜102之间的连接处产生缝隙。
请一并参阅图1和图2，图2是图1中的消融封堵系统1000的消融封堵装置100的第一实施方式的结构示意图。在本实施例中，成型后的覆膜102通过缝合方式固定于支撑骨架101上。具体地，覆膜102的边缘与支撑骨架101的连接处形成有间隔设置的多个缝合点103。覆膜102通过缝合线在每一个缝合点103处与支撑骨架101进行缝合连接。如图2所示，缝合点103设置有多个，部分缝合点103设置于覆膜102的近端边缘，部分缝合点103于覆膜102的其他位置，具体设置于电极300的远侧，以及锚刺13的远侧。 在一些实施方式中，缝合点103均设置于覆膜102的边缘。在一些实施方式中，缝合点103在图2基础上还设置于覆膜102的其他位置，提高覆膜102与支撑骨架101的连接强度。
缝合线沿支撑骨架101的周向缝合至少一圈。缝合线可选为非吸收生物相容性缝合线，例如但不局限于金属线、棉线、聚酯、聚丙烯等。缝合线也可以选用可吸收生物相容性缝合线，例如但不局限于羊肠线、聚乙交酯、多丝非生物可降解缝合线等，从而缝合线在使用到一定时间后会逐渐降解，进而有利于减小对人体的刺激，进而能够降低消融封堵装置100长期留置的远期并发症率。缝合线还可以选用缠绕纤维线等。在本实施例中，缝合线的材料包括，但不局限于聚丙烯、聚对苯二甲酸乙二醇酯、聚四氟乙烯中的至少一种。优选地，缝合线的材料选用有较好的抗拉强度和硬度的聚丙烯。缝合线采用的是双股缝合线，使覆膜102与支撑骨架101有更好的连接强度。在其它实施方式中，缝合线还可以采用更多股股缝合线，或者一股缝合线。
请一并参阅图1和图3，图3是图1中的消融封堵系统1000的消融封堵装置100a的第二实施方式的结构示意图。如图3所示，在其它一些实施例中，覆膜102可以通过浸渍方式或喷涂方式直接形成于支撑骨架101上。本申请的覆膜102通过浸渍方式或喷涂方式直接形成于支撑骨架101上，从而覆膜102的孔隙率相对较小，进而增强了覆膜102的绝缘性能，此外覆膜102能够紧密地形成于支撑骨架101的外表面上，以实现覆膜102与支撑骨架101之间的无缝连接，从而确保电极300与支撑骨架101之间具有良好的绝缘性。
请一并参阅图2、图3和图4A至图4B，图4A是图2以及图3中的消融封堵装置100a的覆膜102的扫描电镜图，即图4A所示为本申请实施例的覆膜102的扫描电镜图，即通过浸渍方式或喷涂方式直接形成于支撑骨架101上；或者，通过浸渍方式、溶液浇铸方式、喷涂方式、流延成型方式、模压成型方式或注塑成型方式而制得的覆膜102的扫描电镜图；图4B是现有的通过静电纺丝工艺制得的覆膜102的扫描电镜图。如图4A所示，在1万倍放大条件下，覆膜102的表面无缺陷，即覆膜102的表面平整。图4A的扫描电镜图看不到覆膜102具有明显孔，这表明通过浸渍工艺制得的覆膜102的孔隙率以及孔径较小，覆膜102通过从而确保覆膜102具有更好的绝缘性，避免电极300在通电状态下，电极300与支撑骨架101之间电导通的问题出现。如图4B所示，在1万倍放大条件下，现有的覆膜的表面可以看到明显的孔，这表明通过静电纺丝工艺制得的覆膜的孔隙率与孔径较大，从而电极与支撑骨架之间的绝缘性能较差，从而电极容易在孔隙较大的位置与支撑骨架电性耦合，使得支撑骨架导电产生火花，组织容易焦痂，甚至会造成心脏穿孔导致心包积液。需要说明的是，用于电镜扫描的本申请实施例制得的覆膜102与现有的静电纺丝工艺制得的覆膜的材料相同。
可以理解的是，覆膜102的绝缘性能受覆膜102的孔隙率及厚度影响，覆膜102的厚度越厚，绝缘性能越好，但是覆膜102的厚度过厚会影响消融封堵装置100的力学性能，以及可降解覆膜102的降解能力或增大覆膜102所造成体内的一些炎症、慢性病的概率，为了兼顾覆膜102的绝缘性能及降解能力或生物相容性，覆膜102的孔隙率小于2.5％，覆膜102的厚度为0.05mm-0.3mm。
覆膜102的材料包括绝缘材料，从而避免电极300在消融状态下，电极300与支撑骨架101电性耦合，使得支撑骨架101导电的问题出现。在一些实施例中，覆膜102由绝缘材料制成，从而强了覆膜102整体的绝缘性能。在其它一些实施例中，覆膜102的内侧面和/或外侧面均设置有绝缘涂层。
可选地，在一些实施例中，覆膜102的材料包括绝缘的可降解材料，即覆膜102由绝缘的可降解材料制成，从而在确保覆膜102与支撑骨架101及电极300之间的绝缘性能，同时有利于提高消融封堵装置100a的生物相容性。如此，覆膜102在使用到一定时间后会逐渐降解，并最终变成容易被人体吸收和代谢的水和二氧化碳，从而有利于减小对人体的刺激，进而能够降低消融封堵装置100a长期留置的远期并发症率。绝缘的可降解材料包括但不局限于聚乳酸(polylactic acid，PLA)、聚己内酯(Polycaprolactone，PCL)中的一种或者几种聚合物的共聚物或共混物。
在其它一些实施例中，覆膜102的材料还可以包括绝缘的不可降解材料，不可降解材料化学性能稳定，相应地结构稳定不容易破坏，长期机械性能特别是力学性能较为稳定。绝缘的不可降解材料包括但不局限于聚酰亚胺、聚砜(Polysulfone，PSF)、聚迷砜树酯(Polyethersulfone，PES)、聚乙烯吡咯烷酮(Polyvinyl pyrrolidone，PVP)、聚甲基丙烯酸甲酯(Polymethyl methacrylate，PMMA)、氢化苯乙烯-丁二烯嵌段共聚物(Styrene ethylene butylene styrene，SEBS)、热塑性聚氨酯弹性体(Thermoplastic polyurethanes，TPU)、聚氨酯(Polyurethane，PU)、聚对二甲苯、硅橡胶及其它高分子材料中的一种或它们之间的任意组合。
请一并参阅图2和图5，图5是图2中的消融封堵装置100a的支撑骨架101与电极300的结构示意图，即在图5中，省略了图2中消融封堵装置100中的覆膜102，以便说明支撑骨架101与电极300的结构以及两者之间的关系。需要说明的是，图3中所示的支撑骨架101以及电极300的结构以及相对位置关系可以参考图5中的相应说明。
支撑骨架101构造为网状结构。支撑骨架101可以由具有形状记忆效应的编织丝编织而形成网状结构；或者，支撑骨架101还可以由切割具有形状记忆效应的杆状结构、管状结构及板状结构中的至少一者而形 成网状结构。支撑骨架101的材料包括具有生物相容性的金属材料，从而增强了支撑骨架101的整体强度。支撑骨架101的材料包括不可降解金属材料。不可降解金属材料包括但不局限于不锈钢、钨合金、钴基合金和镍钛合金中的至少一种。在其它一些实施例中，支撑骨架101的材料包括可降解金属材料。可降解金属材料包括，但不局限于镁合金、铁合金或锌合金中的至少一种。在一些实施例中，支撑骨架101的材料还可以包括或进一步包括高分子聚合物材料、不可降解的非金属材料、可降解的非金属材料中的至少一者或它们之间的任意组合。
本实施例中，消融封堵装置100为左心耳消融封堵装置。支撑骨架101构造为双层网盘。双层网盘包括多个网孔。多个网孔的大小、形状可以根据实际需要设定，本申请不做具体限定。支撑骨架101包括锚定部10及设置于锚定部10近端的封堵部20。锚定部10用于释放在左心耳内部，与左心耳内壁组织相互锚定，封堵部20用于封堵在左心耳口部，避免左心耳内部的血栓流出。封堵部20与锚定部10均可以设置至少一用于阻挡左心耳内部血栓流出的阻流膜，在一些实施方式中，阻流膜用于阻挡左心耳口部形成血流，进而避免左心耳内部血栓流出引起脑卒中。如图5所示，锚定部10和封堵部20共同形成多盘式结构。在本实施例中，锚定部10和封堵部20共同形成双盘式结构。锚定部10在支撑骨架101的远端形成锚定盘，封堵部20在支撑骨架101的近端形成密封盘。在一些实施例中，锚定部10和封堵部20共同合围形成单盘式结构。
请一并参阅图2、图5和图6，图6是图5中的消融封堵装置100的支撑骨架101设置绝缘涂层105的结构示意图。可选地，支撑骨架101包括承载区段104。在本实施方式中，承载区段104为锚定部10轴向上的一段区域。电极300设置于覆膜102背离支撑骨架101的外侧面上；电极300对应承载区段104设置，支撑骨架101对应承载区段104的表面设置有绝缘涂层105或绝缘套管，以使得覆膜102和绝缘涂层105或绝缘套管共同起到绝缘作用，不仅提高了支撑骨架101的耐压值，并且提高了支撑骨架101与电极300之间绝缘的可靠性。如此，一方面，在覆膜102发生破损时，支撑骨架101上的绝缘涂层105或绝缘套管仍可以起到支撑骨架101与电极300之间绝缘的作用；另一方面，在支撑骨架101上的绝缘涂层105或绝缘套管发生破损时，覆膜102仍可以起到支撑骨架101与电极300之间绝缘的作用，从而大大提高了支撑骨架101与电极300之间绝缘的可靠性和稳定性。
锚定部10和封堵部20均包括多根支撑杆1010，多根支撑杆1010共同构成支撑骨架101。在一些实施例中，承载区段104可以是锚定部10的全部区域，从而方便加工工艺。具体地，锚定部10可以由切割工艺制成，锚定部10中的切割而成的多根支撑杆1010表面均设置绝缘涂层，及/或套设有绝缘套管。在其他实施方式中，锚定部10由编织丝编织而成，比如锚定部10中的每根支撑杆1010由至少一根编织丝结合为一股构成，比如每根支撑杆1010包括一根编织丝，或者每根支撑杆1010中包括多根编织丝，多根编织丝结合为一股，比如绞接为一股，并在支撑杆1010的表面套设绝缘套管，及/或设置绝缘涂层；或者，锚定部10的每根支撑杆1010中的每根编织丝的表面均设置有绝缘涂层，及/或穿套绝缘套管。在其它一些实施例中，承载区段104可以是锚定部10的部分区域，以节省成本。
在一些实施例中，承载区段104还可以设置于封堵部20，比如设置于封堵部20的近端部；或者，设置于封堵部20的远端部；或者，设置于封堵部20的中部；或者，设置于封堵部20的近端部、中部及远端部中的至少两者，从而提升了锚定部10上设置的电极300与构成封堵部20的第二骨架21之间的绝缘性能。
请再次参阅图2和图5，在本实施例中，覆膜102包覆于锚定部10外。覆膜102可以部分地或全部地包覆在锚定部10外，以阻挡左心耳内的血栓进入左心房。可选地，覆膜102部分地包覆在锚定部10外，且位于锚定部10的远端外，从而防止左心耳脱落的血栓顺着血流方向从锚定部10内流出，进而避免血栓随着血液流至全身各处而导致脑栓塞(脑卒中)、肢体动脉栓塞等问题。支撑骨架101包括第一骨架11和第二骨架21。第一骨架11构成锚定部10；第二骨架21构成封堵部20。覆膜102包覆于第一骨架11外。覆膜102还可以用于约束第一骨架11远端的半球状结构，使之不易变形以增强结构稳定性，同时增大了第一骨架11与心肌组织的直接接触面积，减小了第一骨架11的材料对心肌组织的刺激作用，起到一定的保护作用。
在本实施例中，电极300设置于消融封堵装置100上。具体地，电极300设置于覆膜102背离支撑骨架101的外侧面上，从而实现电极300与支撑骨架101的绝缘设置。可选地，电极300在覆膜102的周向上环绕至少一圈，从而增强了消融封堵装置100的消融效率。
在一些实施例中，电极300与覆膜102固定连接。具体地，电极300可以通过粘接方式、溶液浇铸方式、缝合等方式固定于覆膜102上。
在其它一些实施例中，电极300与覆膜102及支撑骨架101固定连接。具体地，电极300通过缝合线缝合于覆膜102及支撑骨架101上。缝线由绝缘材料制成，从而进一步避免电极300与支撑骨架101之间的电导通。缝合线的材料包括，但不局限于聚四氟乙烯、聚乙交酯、聚乙丙交酯、聚乳酸、胶原蛋白、尼龙缝合线、聚酯缝合线中的至少一种。优选地，缝合件为聚四氟乙烯制成的缝合线。由于聚四氟乙烯材料 的机械强度高，因此提升了缝合件的韧性。
请再次参阅图2，在本实施例中，电极300可以构造为丝状电极，或者是片状电极。具体地，当电极300为丝状电极，且所述丝状电极造为波形结构时，所述丝状电极在所述波形结构的波峰和/或所述波谷处与覆膜102固定连接。
具体地，电极300在波峰和波谷处形成有多个连接点301，电极300在多个连接点301处与覆膜102通过粘接方式(或者缝合、热压方式)连接在一起，从而避免电极300发生移位，进而提升了消融封堵装置100的消融的准确性。在一些实施例中，电极300包括连接任意相邻的两个连接点301的连杆302。电极300在多个连接点301及多个连杆302处与覆膜102通过粘接方式(或者缝合、热压方式)连接在一起，从而进一步提升了电极300与覆膜102之间连接的稳定性和可靠性。
在一些实施例中，电极300还可以构造为点状电极、柱状电极、筒状电极、环状电极中的至少一种。电极300构造为波形结构，即所述丝状电极造为波形结构。具体地，电极300构造为由多个Z字形结构或多个正弦波形结构合围形成，电极300包括多个波峰和多个波谷，且波峰与波谷依次交替排布设置。其中呈波形的电极300在其轴向的方向上形成多个转折点，其中远端的转折点定义为波峰，近端的转折点定义为波谷。电极300的材料可以是但不局限于铂铱合金、黄金、镍钛合金或者不锈钢等中的一种或它们之间的任意组合。
在图5所示的实施方式中，电极300为丝状电极，丝状电极围绕设置锚定部10一圈。在一些变化的实施方式中，电极300为绕设于支撑骨架101外围的多圈丝状电极，多圈丝状电极之间相互间隔，电极300还可以设置于封堵部20。在电极300为上述的点状电极、柱状电极、筒状电极、环状电极等形式的实施方式中，电极300可以在支撑骨架101的外围设置多圈。
可选地，在一些实施例中，当所述丝状电极造为波形结构时，所述丝状电极在所述波形结构的波峰和/或所述波谷处与覆膜102和第一骨架11固定连接，从而提升了电极300与覆膜102和第一骨架11之间连接的稳固性和可靠性。
在其它一些实施例中，当电极300构造为点状电极、柱状电极或筒状电极时，所述点状电极、柱状电极或筒状电极与第一骨架11可以错开设置，且与覆膜102固定连接，从而进一步提高电极300与支撑骨架101之间的绝缘性能。
请再次参阅图2和图5，支撑骨架101上设置有多个锚刺13。多个锚刺13沿支撑骨架101的外表面的周向间隔设置。多个锚刺13相对覆膜102外露。多个锚刺13与电极300错开设置。多个锚刺13均设置于电极300的同一侧。多个锚刺13的表面均设置有绝缘涂层。可以理解地，锚刺13的表面上设置的绝缘涂层容易破损，在多个锚刺13与电极300距离较近时，则电极300容易与多个锚刺13电性耦合，使得多个锚刺13导电，尤其是锚刺13的尖端(即自由端或近端)容易放电，并产生火花以及焦痂，甚至造成心脏穿孔导致心包积液。
多个锚刺13可以位于电极300的近端侧和/或远端侧。在其它实施例中，多个锚刺13可以设置于第一骨架11的其它合理位置，只要多个锚刺13能够刺入左心耳内壁以增强消融封堵装置100的锚定性并且不妨碍消融封堵装置100上的电极300对左心耳内壁进行消融即可，本申请不做具体限定。
本实施例中，多个锚刺13与第一骨架11一体切割成型，从而提升了多个锚刺13与第一骨架11之间连接的稳固性，且简化组装。在其它实施例中，多个锚刺13还可以通过焊接方式、粘接方式、安装结构等方式固定于第一骨架11上。例如，可将镍钛金属丝或者镍钛金属杆作为锚刺13，并且通过套筒或者焊接等方式固定于第一骨架11上。多个锚刺13与用与第一骨架11采用相同或者不同的材料形成。可选地，多个锚刺13设置于第一骨架11中部的多个直杆上。多个锚刺13朝第一骨架11的外侧且朝近端延伸。多个锚刺13的数量为5-15个，本此处不做具体限定。
在一些实施例中，第一骨架11上对应每一个锚刺13的位置处开设有收容槽。每一个锚刺13可活动地收容于相应的收容槽内。具体地，在输送消融封堵装置100的过程中，每一个锚刺13收容于相应的收容槽内，从而避免锚刺13划伤封堵组织；在消融封堵装置100释放在待封堵组织区域时，每一个锚刺13从相应的收容槽内伸出，从而实现多个锚刺13能够刺入左心耳内壁，进而能够有效防止消融封堵装置100脱落。
在本实施例中，多个锚刺13设置在锚定部10的第一骨架11上。多个锚刺13沿第一骨架11外表面的轴向连续设置或者间隔设置。具体地，锚定部10的多根支撑杆1010包括多根第一支杆1010a和多根第二支杆1010b。多根第一支杆1010a设置于锚定部10的中部，多根第二支杆1010b设置于锚定部10的远端侧和近端侧，且每根第一支杆1010a的两端连接相应的第二支杆1010b。每个锚刺13设置于相应的第一支杆1010a上。第一支杆1010a的形状可以但不局限于呈杆状，第二支杆1010b的形状可以但不局限于呈V形、W形、Z形或S形。每一根第一支杆1010a可以连接多根第二支杆1010b，以提升了锚定部10的整体支撑强度以及回弹性等机械性能。在本实施例中，每一根第一支杆1010a的一端连接有两根第二支杆1010b。每一个锚刺13设置于相应的第一支杆1010a的外表面。
请一并参阅图2和图7，图7是图1中的消融封堵系统1000的消融封堵装置100c的第三实施方式的结构示意图。在一些实施例中，锚刺13穿出覆膜102，且与电极300间隔设置。可选地，多个锚刺13与电极300的波峰和波谷错开设置，从而避免多个锚刺13与电极300发生短路，且在消融封堵装置100c植入左心耳后，多个锚刺13能够刺入左心耳内壁以进一步锚定消融封堵装置100c，能够有效防止消融封堵装置100c脱落。
请参阅图7，在本实施例中，多个锚刺13设置于电极300的近端侧，且每一个锚刺13设置于电极300的相邻的两个波谷之间，从而保证多个锚刺13与电极300的各个部位保持一个绝缘距离，进而避免电极30与多个锚刺13及支撑骨架101之间发生短路。可选地，在锚定部10的轴向方向上，多个锚刺13的近端与电极300的波谷的位置大概对齐，即多个锚刺13的近端与电极300的波谷大致位于同一高度。在锚定部10的圆周方向上，多个锚刺13与电极300的波峰大概对齐，即电极300的波峰与相应的锚刺13正相对。
请一并参阅图2和图8A，图8A是图1中的消融封堵系统1000的消融封堵装置100e的第四实施方式的结构示意图。在一些实施方式中，可减小电极300的振幅，即电极300在轴向上占据的范围缩小，波动程度更为平缓，及/或增大电极300与锚刺13之间的距离，使得在第一骨架11的每根第一支杆1010a的位置上均可以设置一个锚刺13，从而改善锚定部10的锚定性能。
优选地，电极300与覆膜102连接的位置，与第一骨架11错开设置，即对应第一骨架11的网孔设置。在本实施例中，电极300为丝状电极，且所述丝状电极造为波形结构。所述波形结构的波峰和波谷用于和覆膜102连接，所述波形结构的波峰和波谷与第一骨架11错开设置，从而避免电极300的波峰与波谷与第一骨架11之间距离太近，而出现电极300的波峰与波谷固定设置(比如采用粘接或缝合等方式)于覆膜102上之后，电极300的波峰以及波谷与支撑骨架101发生短路的风险，进而进一步提高电极300与支撑骨架101之间的绝缘性能。
多个锚刺13设置于电极300的远端侧。电极300的相邻的两个波峰之间对应设置有至少两个锚刺13，如此通过增加锚刺13的数量，以进一步提升锚定部10的锚定性能。在本实施例中，电极300的相邻的两个波峰之间对应设置有两个锚刺13。每一个锚刺13的自由端与电极300间隔设置，从而避免电极300与多个锚刺13电性耦合而出现锚刺13的尖端放电并且产生火花以及焦痂的现象，且避免心脏穿孔而导致心包积液的现象。
在一些实施例中，每一个锚刺13设置于电极300的相邻的两个波峰之间，从而保证多个锚刺13与电极300的各个部位保持一个绝缘距离，进而避免电极30与多个锚刺13及支撑骨架101之间发生短路。可选地，在锚定部10的轴向方向上，多个锚刺13的远端与电极300的波峰的位置大概对齐，即多个锚刺13的远端与电极300的远端在锚定部10上大致位于同一高度。在锚定部10的圆周方向上，多个锚刺13与电极300的波谷大概对齐，即电极300的波谷与相应的锚刺13正相对。
如图8B所示，消融封堵装置100e还包括设置于支撑骨架101上的导线310，导线310采用生物相容性较佳的导电材料制成，导线310与电极300电连接，电极300用于通过导线310连接至外部脉冲发生器。在一些实施方式中，导线310与电极300为一体结构，在一些实施方式中，导线310与电极300为分体结构。导线310可以通过缝合、粘接、热压等方式固定于覆膜102外侧，也可以固定于覆膜102以及第一骨架101，比如导线310通过缝合工艺缝合固定于覆膜102以及第一骨架101，缝合线穿过覆膜缠绕第一骨架101以及导线310。为保证导线310不用于对组织进行消融，优选地，在导线310表面做绝缘处理，绝缘处理的方式包括但不限于以下方式，在导线310表面镀设绝缘涂层，套设绝缘套管，包覆绝缘膜。
优选地，绝缘连接件40的远端具有导电区段，导线310远离电极300的一端固定连接该导电区段，导电区段用于输送装置电连接，从而电极300依次通过导线310、导电区段、输送装置电连接至外部脉冲发生器。
如图8A所示，在一些实施例中，消融封堵装置100e还包括设置于支撑骨架101上的用于对所述待消融组织进行消融的消融件50，当消融封堵装置100e外接用于输出脉冲能量的脉冲发生器时，所述脉冲发生器能够向电极300与消融件50可以传输极性不同的脉冲能量，以便于消融封堵装置100e对组织进行双极性消融。此外，电极300与消融件50之间能够产生脉冲消融电场，位于一定电场强度范围内的心肌组织均会被脉冲能源消融，从而实现不可逆电穿孔。
可选地，消融件50与多个锚刺13分别设置于电极300的两侧。可以理解地，锚刺13的表面上设置的绝缘涂层容易发生破损，若将多个锚刺13设置在消融件50和电极300之间，在电极300与消融部件50之间产生的脉冲消融电场的作用下，多个锚刺13的尖端容易出现放电的现象，并产生火花以及焦痂，甚至造成心脏穿孔导致心包积液。因此，本申请实施例将多个锚刺13设置在电极300的远端侧，从而降低多个锚刺13的尖端受消融电场的影响而导致尖端放电的问题出现，进而提升了消融封堵装置100e消融的安全性、稳定性以及消融效果。
消融件50设置于封堵部20上。具体地，在一些实施例中，消融件50可以独立于封堵部20的第二骨 架21而固定于第二骨架21上，即为额外设置在第二骨架21上的导电件。可选地，消融件50与第二骨架21绝缘设置，从而避免消融件50与电极300相互短路。第二骨架21的表面可以设置有绝缘涂层或绝缘套管。可选地，消融件50在封堵部20的周向表面设置，以尽量贴近左心耳口部组织，并且消融件50在消融封堵装置100e的周向上围成至少一个环形，以对左心耳口部形成环形的消融带。
在一些实施例中，消融件50作为封堵部20的第二骨架21的一部分或全部。在本实施例中，消融件50作为封堵部20的第二骨架21的一部分，比如消融件50为第二骨架21远离锚定部10的边缘部分，便于消融件50贴靠左心耳口部组织提高消融成功率。第二骨架21对应消融件50的部分不作绝缘处理，第二骨架21除消融件50的其余部分绝缘处理，从而确保采用消融件50进行消融的精准性。
在一些实施例中，第二骨架21的全部也可以作为消融件50。在外部消融能量源为射频信号源、或微波理疗仪的情况下，第二骨架21可传输单一射频信号至左心耳内壁组织。可以理解的是，消融件50和电极300可以分别用于传输不同射频能量、或者微波能量，或者，消融件50和电极300分别对应传输脉冲能量、微波能量或脉冲能量的任意一种。具体地，封堵部20的整个第二骨架21用于传输消融能量，以进行环状消融，或用于采集组织生理信号，以进行标测。当锚定部10锚定在左心耳内时，封堵部20能够完全堵住左心耳入口处，封堵左心耳内部的血栓，有效地防止血栓进入左心房。同时封堵部20也能够很好地消融左心耳入口内壁组织，具有很好的消融效果。具体地，左心耳口部组织相对于左心耳内部组织更加规则，表面光滑，对左心耳口部消融，更有利于在口部形成完整的消融带，进而便于在左心耳口部彻底将左心耳与左心房电隔离。
请再次参看图2与图5，锚定部10与封堵部20相互绝缘。在一些实施例中，支撑骨架101还包括绝缘连接件40。锚定部10及封堵部20通过绝缘连接件40连接且电隔离，避免消融件50与电极300之间短路。绝缘连接件40设置于锚定部10及封堵部20之间，以使锚定部10与封堵部20绝缘。在一些实施例中，绝缘连接件40可以省略，锚定部10与封堵部20的连接处设置有绝缘区段，以实现两者之间的绝缘性能。第一骨架11与第二骨架21固定连接，以使得封堵部20与锚定部10连接于一体。在本实施例中，第一骨架11与第二骨架21通过绝缘连接件40固定连接在一起。
具体地，第一骨架11的远端朝锚定部10的中心聚集并沿消融封堵装置100的中轴线延伸而形成第一连接部111。第二骨架21在靠近锚定部10的一侧聚集并沿消融封堵装置100的中轴线延伸而形成第二连接部211。第一连接部111和第二连接部211固定于绝缘连接件40上，从而实现锚定部10与封堵部20之间的固定连接。
在本实施例中，绝缘连接件40构造为绝缘套管。绝缘套管设置于第一连接部111和第二连接部211之间。锚定部10由具有形状记忆效应的管状或板状材料通过激光切割而成，从而提升了锚定部10的支撑性，进而提升了锚定部10将消融封堵装置100锚定于左心耳口部的可靠性。封堵部20采用具有形状记忆效应的编织丝编织而成，且编织丝在靠近锚定部10的一侧聚集而铰接为一股并向外延伸而形成第二连接部211，从而便利于封堵部20覆盖于左心耳口部从而阻塞隔离左心房与左心耳，避免左心耳内的血栓进入左心房及避免封堵部20损伤左心房。其中，绝缘连接件40中的至少部分由绝缘材料制成，比如为绝缘管。锚定部10的一端连接于绝缘连接件40的远侧，封堵部20连接于绝缘连接件40的近侧。
可以理解地，第一连接部111和第二连接部211均可以采用多根编织丝编织而成，第一连接部111和第二连接部211的每根编织丝或整股编织体的外表面设置绝缘涂层，从而进一步避免锚定部10与封堵部20之间的电性连接，且无需改进编织方式，简化加工工艺。
在一些实施例中，第一骨架11与第二骨架21可以直接通过焊接的方式固定连接。在其它一些实施例中，第一骨架11与第二骨架21均采用金属丝编织热定型制成时，第一骨架11与第二骨架21可以一体编织而成，也可以分别编织后通过焊接或者通过连接管等方式固定连接在一起。在其它一些实施例中，封堵部20的第二骨架21靠近锚定部10的部分采用编织方式制成，封堵部20的第二骨架21远离锚定部10的部分采用切割方式制成。
需要说明的是，第一骨架11具有沿轴向延伸的第一通孔110，第二骨架21也具有沿轴向延伸的第二通孔210，绝缘连接件40具有沿轴向延伸的第三通孔401。当第一骨架11固定连接第二骨架21时，第一骨架11的第一通孔110、第二骨架21的第二通孔210及绝缘连接件40的第三通孔401对应连通，从而形成沿轴向贯通消融封堵装置100相对两端的通道1001。当消融封堵装置100与输送装置200可拆卸连接时，通道1001与鞘管201的管腔连通。
请再次参阅图5，构成封堵部20的第二骨架21呈盘状，并在图5所示的附图视角中，即在支撑骨架101轴线穿过的平面中呈现为梯形的形状。具体地，封堵部20包括近端盘面23、远端盘面24、以及连接在近端盘面23与远端盘面24之间的腰部25。近端盘面23设置于远端盘面24的近侧，近端盘面23与远端盘面24均呈大致平面状，近端盘面23的径向尺寸大于远端盘面24的径向尺寸。腰部25在近端与远端之间延伸呈锥筒状，腰部25近端的径向尺寸小于腰部25远端的径向尺寸。腰部25用于贴靠左心耳口部组织。
为提高电极300与消融件50之间的绝缘性能，避免构成锚定部10的第一骨架11与构成封堵部20的第二骨架21之间相互电导通，第二骨架21的远侧部分，即朝向锚定部10的部分进行了绝缘处理。具体地，第二骨架21包括绝缘区段27与消融区段28。其中，消融区段28设置于绝缘区段27远离第一骨架11的一侧。第二骨架21中位于消融区段28中的部分用于作为消融件50，即第二骨架21中位于消融区段28的部分用于向组织传输消融电能，其表面导电，不需要做绝缘处理。消融区段28以外的部分为绝缘区段27，第二骨架21中位于绝缘区段27的部分，其表面不用于对组织进行消融，需要做绝缘处理。绝缘区段27一方面能够提高构成锚定部10的第一骨架11与构成封堵部20的第二骨架21之间的绝缘性能，另一方面，绝缘区段27能够减小封堵部20中消融件50的比例，即减少消融件50的导电面积，从而便于集中消融能量对组织进行消融，保证了消融深度与消融效果，避免消融件50导电面积过大，消融能量分散，消融深度较浅而不能达到透壁的环形消融带。
进一步地，消融区段28为设置于封堵部20周向边缘的部分，该部分用于贴靠左心耳口部组织，便于对口部组织进行消融。在一些实施方式中，消融区段28可以设置于第二骨架21的腰部25。在另一些实施方式中，消融区段28设置于第二骨架21的腰部25以及近端盘面23。在其它一些实施方式中，消融区段28设置于第二骨架21的近端盘面23；或者，消融区段28还设置于远端盘面24的一部分，例如设置于远端盘面24靠近腰部25的部分。可选地，消融区段28设置于第二骨架21的径向尺寸相对较大的近端盘面23以及腰部25，不仅提升了消融效率，且增大了消融区段28与电极300之间的距离，从而提升了两者之间的绝缘性能。
绝缘区段27设置于第二骨架21的远端盘面24，特别是远端盘面24中容易接触第一骨架11的部分，比如在第二骨架21中与第一骨架11在轴向上的投影重叠的部分。消融区段28通过绝缘区段27与第一骨架11绝缘设置，从而提升了第一骨架11于第二骨架21之间的绝缘性能。
第二骨架21为导电金属丝编织制成，如图5所示，消融区段28构造为由编织丝编织而成的密网编织结构，其中，所述编织丝为金属丝。第二骨架21在绝缘区段27中的每根支撑杆1010为多根编织丝结合而成的一股编织丝，比如编织丝之间通过编织、粘接或利用其他器件进行固定的方式结合为一束，且每一股编织丝进行绝缘处理，如此相对于对每根编织丝进行绝缘处理更加方便。具体地，绝缘区段27中每根编织丝可以不做绝缘处理，先结合为一股，然后在整股编织体的外表面设置绝缘涂层或套设绝缘套管。在一些实施例中，每根编织丝设置绝缘涂层后再结合为一股，一股编织丝外围整体可套设绝缘套管，从而提升了第二骨架21在绝缘区段27中的每根支撑杆1010的绝缘性能。
在其他一些实施例中，绝缘区段27中多根编织丝编织(绞接)为一股，其中，每一根编织丝的外围套接有绝缘套管；或者，多根编织丝相互编织呈一股，整股编织体的外围套接有绝缘套管，从而实现绝缘区段27与消融区段28及第一骨架11之间的绝缘性能。
在一些实施例中，消融区段28对应设置有消融件，第二骨架21中位于消融区段28中的部分可以绝缘处理，或者，可以不绝缘处理。在这种实施例中，绝缘处理的方式可以参看上述绝缘区段27进行绝缘处理的详细描述，在此不做具体限定。
请一并参阅图2和图9，图9是图2中的消融封堵装置100的俯视图。在一些实施例中，支撑骨架101用于植入至左心耳的缺口处，覆膜102包覆于支撑骨架101的远端，覆膜102在对应电极300位置以外的区域上开设有供血流通过的多个微孔33，从而避免电极300与支撑骨架101之间在微孔33处电导通而出现短路的现象。每一个微孔33的尺寸小于0.25mm，从而限制所述左心耳内的血栓从消融封堵装置100内流出，并使得左心耳与左心房中的血液形成正常的循环，且避免左心耳血栓脱落后随着血液流至全身各处而导致脑栓塞(脑卒中)、肢体动脉栓塞等问题。
请一并参阅图1和图10，图10是图1中的消融封堵系统1000的消融封堵装置100f的第五实施方式的结构示意图。第六实施方式中的消融封堵装置100f的结构与图8A中的消融封堵装置100e的结构相似，不同之处在于，消融封堵装置100f还包括绝缘膜106。绝缘膜106包覆于第二骨架21的外表面，从而提高了第一骨架11与第二骨架21之间的绝缘性能。
具体地，消融件50设置封堵部20的近端侧，且相对绝缘膜106外露，便于接触组织对组织进行消融。消融件50构造为环状，以在左心耳口部形成环状消融带，提高消融效率。绝缘膜106设置于封堵部20的远端侧，即绝缘膜106设置于第二骨架21靠近锚定部10的一侧，从而增强了锚定部10与封堵部20之间的绝缘性，避免第一骨架11接触第二骨架21的远端而导致消融件50与第一骨架11以及电极300短路，保证了消融封堵装置100f的安全可靠性，并且，绝缘膜106用于将封堵部20中不作为消融件50的部分第二骨架21表面进行绝缘处理，减小了封堵部20中消融件50的比例，即减小了消融件50的表面积，有利于将消融能量集中在较小的消融范围内，消融能量集中，保证了消融深度与消融效果。在一些实施例中，绝缘膜106还可以设置于封堵部20的远端侧和近端侧。在一些实施例中，消融件50可以设置于绝缘膜106上，且消融件50与第一骨架11间隔设置，从而避免消融件50与第一骨架11电导通而出现短路的现象，且保证了消融封堵装置100f的消融效果。
请一并参阅图1和图11至图12，图11是图1中的消融封堵系统1000的消融封堵装置100g的第六实施方式的结构示意图；图12是图11中的消融封堵系统1000的消融封堵装置100g的支撑骨架101的结构示意图。第六实施方式中的消融封堵装置100g的结构与第四实施方式中的消融封堵装置100e的结构相似，不同之处在于，支撑骨架101构造为单盘结构，呈柱塞状。其中，支撑骨架101的轮廓可以为直径由近端向远端逐步减小的锥台状。支撑骨架101的轮廓还可以是圆盘状、圆筒状等。支撑骨架101的轮廓为锥台状，且最大直径大于左心耳开口的直径，支撑骨架101的周向表面为锥面。当消融封堵装置100g植入左心耳后，支撑骨架101的远端进入左心耳内，支撑骨架101的直径最大处封堵于左心耳开口邻近左心房的一侧，左心耳口部的心肌组织贴合于支撑骨架101围绕周向的锥面上。
支撑骨架101包括远侧区段1011和与远侧区段1011间隔设置的近侧区段1012。远侧区段1011形成于锚定部10内，近侧区段1012形成于封堵部20内。在本实施例中，电极300对应远侧区段1011设置，消融件50对应近侧区段1012设置。远侧区段1011作为承载区段或绝缘区段，即支撑骨架101对应远侧区段1011的表面设置有绝缘涂层或绝缘套管。近侧区段1012作为消融区段，即支撑骨架101对应近侧区段1012中的部分用于作为消融件50，即第二骨架21中位于近侧区段1012的部分可以导电，且用于向组织传输消融电能。在其他一些实施例中，第二骨架21中位于近侧区段1012额外设置有独立于第二骨架21的消融件50。
可选地，远端区段1011作为承载区段，即第一骨架11中位于远侧区段1011中的部分进行绝缘处理，相关地，第二骨架21中除位于近侧区段1012之外的部分均进行绝缘处理，从而保证电极300与消融件50之间的绝缘性能，进而提升了消融封堵系统1000使用的安全性和稳定性。在一些实施例中，远侧区段1011和近侧区段1012可以均作为承载区段或绝缘区段。
在一些实施方式中，支撑骨架101还包括位于远侧区段1011和近侧区段1012之间的绝缘区段1013。绝缘区段1013由绝缘材料制成，第一骨架11中位于远侧区段1011中的部分为金属材质，与绝缘区段1013中的骨架采用熔融连接，第二骨架21中位于近侧区段1012中的部分为金属材质，与绝缘区段1013中的骨架采用熔融连接。在一些实施方式中，第一骨架11中位于远侧区段1011中的部分及第二骨架21中位于近侧区段1012中的部分为同一材料一体制成。在一些实施方式中，支撑骨架101位于绝缘区段1013与远侧区段1011的部分均由绝缘材料制成，从而远侧区段1011表面不需要做绝缘处理。
在本实施例中，覆膜102包覆于第一骨架11的远端。在本实施例中，覆膜102包覆锚定部10的整个外表面，封堵部20相对覆膜102外露。构成封堵部20的第二骨架21的远端部分绝缘处理，从而增强支撑骨架101与电极300及消融件50之间的绝缘性能。在这种实施例中，绝缘处理的方式可以参看上述消融区段进行绝缘处理的详细描述，在此不做具体限定。
请一并参阅图1和图13至图14，图13是图1中的消融封堵系统1000a的第二实施方式的结构示意图；图14是图13中的消融封堵系统1000a的部分结构的结构示意图。第二实施方式中的消融封堵系统1000a的结构与第一实施方式中的消融封堵系统1000的结构相似，不同之处在于，电极300固定于输送装置200上。
在本实施例中，输送装置200还包括活动导管60。支撑骨架101上沿轴向贯穿设置有通道1001，活动导管60活动地穿设于所述通道1001，活动导管60包括导管本体61，电极300a设置于导管本体61的远端，活动导管60的远端用于在支撑骨架101的远端侧释放。导管本体61上设置有多个间隔设置的电极300a，从而实现了对待消融组织的消融治疗。
活动导管60整体呈管状结构。电极300a密封连接于导管本体61上，以避免活动导管60在人体中工作时，血液或其它体液进入导管本体61的内部，进而确保电极300a工作的稳定性。电极300a与导管本体61之间的连接处采用胶粘方式固定并密闭。具体地，在本实施例中，活动导管60包括管状的导管本体61和多个间隔地设置在导管本体61上的管状或环状的电极300a。管状或环状的电极300a套设在导管本体61外，且管状或环状的电极300a的外表面与导管本体61的外周面相接而形成平整的表面，从而提高了活动导管60输送的顺畅性。在一些实施例中，在一些实施例中，电极300a还可以为点状、半球形结构、钝突起结构或平滑突起结构，从而增大电极300a与目标组织区域接触的接触面，进而提高了消融有效性。为了降低放电的能量损耗，电极300a的材料可以包括但不局限于铂铱合金、纯金、银等高导电性材料中的至少一种。
导管本体61的近端穿过鞘管201的内腔并且连接于控制手柄202。在一些实施例中，导管本体61包括位于导管本体61远端的可调弯段611和位于导管本体61近端的主体段612。可调弯段611固定连接于主体段612的远端。可调弯段611的硬度小于或等于主体段612的硬度，从而主体段612可以对可调弯段611起到支撑的作用，进而方便导管本体61运输至目标组织。导管本体61由高分子材料制成，高分子材料包括但不局限于聚酰胺(Polyamide，PA)、聚醚嵌段聚酰胺(Polyether block amide，Pebax)、尼龙、热塑性聚氨酯弹性体(Thermoplastic urethane，Tpu)等中的至少一种。多个电极300a设置于导管本体61的可调弯段611，从而能够对不同的消融组织区域进行消融。
其中，导管本体61还包括连接可调弯段611和主体段612的过渡段613。主体段612、可调弯段611及过渡段613由导管本体61的近端至远端依次连接。可调弯段611和主体段612通过过渡段613平滑过渡连接。
鞘管201包括同轴设置的内管2011和外管2012，内管2011穿设在外管2012的管腔中。在输送状态下，活动导管60全部收容在内管2011中。通过控制手柄202沿着通道1001推送内管2011，使得内管2011的远端从支撑骨架101的远端伸出，然后从内管2011的远端将活动导管60的可调弯段611释放出来，可对可调弯段611进行调弯处理，使得可调弯段611弯曲为适用的形状，比如图13-图14所示的环形。
在活动导管60的远端在支撑骨架101的远端侧释放时，导管本体61的可调弯段611构造为环形结构。换句话说，导管本体61的可调弯段611由主体段612的远端沿径向向外延伸。可调弯段611由过渡段613远离主体段612的端部环绕主体段612的周向呈环状延伸。多个电极300a间隔地布置在过渡段613和可调弯段611上。
在一些实施例中，可调弯段611整体环绕主体段612的周向呈螺旋状环绕，其可以环绕主体段612呈平面螺旋结构，也可以沿主体段612的轴向逐渐螺旋环绕呈柱状或锥状。可调弯段611的外形根据待消融组织的消融位点来设计，本申请不作具体限定。在一些实施例中，多个电极300a中，相邻的电极300a可以传输相同的消融电能；也可以传输不同的消融电能，如传输极性不同的脉冲消融电能。具体地，多个电极300a包括多个正电极301a和多个负电极302a。正电极301a和负电极302a的数量均包括多个。多个正电极301a和多个负电极302a沿导管本体61的延伸方向交替排布设置，且彼此间隔设置，从而多个正电极301a和多个负电极302a放电时可形成多个脉冲电场以形成环形消融区域，进而提升了对目标组织区域消融治疗效果和效率。多个正电极301a和多个负电极302a的交替排布方式可以是沿导管本体61延伸方向从其近端向远端计数的偶数位数的电极为正电极301a，奇数位数的电极为负电极302a，或者反之亦可。如此，当能量发生装置向多个正电极301a和多个负电极302a传递消融能量时，同一时间放电的电极300a能够沿导管本体61的延伸方向更均匀地分布，从而有利于同时向目标组织区域的多处均匀地传递消融能量，以提升消融效果。
在另一些实施例中，活动导管60还可以用于采集左心耳内部的电生理信号，相应地，电极300a可以用于标测。具体地，电极300a与外部标测设备电性连接，感测消融位点的待消融组织的生理活动，从而判断消融位点是否具有需要消融的待消融组织，从而更针对地对待消融组织进行消融，从而提高了消融效果，进而改善手术的治疗效果，以及对手术的准确定位提供更确切的依据。
在一些实施方式中，多个电极300a中的部分用于实现消融作用，部分用于实现标测功能。
在一些实施方式中，多个电极300a仅用于实现标测功能，不用于实现消融功能。
在一些实施方式中，可调弯段611为预弯段，即可调弯段611具有柔性，其被预定型为环形，在自然状态下呈环状，在输送状态下，可调弯段611在内管的束缚下呈直杆状，可调弯段611从内管释放出来后恢复为环状。可调弯段611呈环状，便于可调弯段中的多个电极300a贴靠左心耳组织内壁，便于电极300a进行消融与标测。
在一些实施例中，导管本体61内设置有用于调节可调弯段611的弯曲度的调节件。可选地，调节件可以预定型，以使得可调弯段611在支撑骨架的远端侧释放后跟随调节件的形状而形变为预设形状，例如但不局限于环形、U形、C形等。
优选地，多个正电极301a和多个负电极302a等间距排布设置，从而使得形成的消融电场比较均匀，消融深度基本一致；电极300a标测电信号时，便于对左心耳内腔中周向一圈的位置进行采集电生理信号，避免了局部位置未被标测的问题发生。多个电极300a等间距设计，还平衡了导管本体61的整体受力，进而促进导管本体61的远端跟随调节件对应的预设形状发生形变。
支撑骨架101可以构造为分体双盘结构，即锚定部10和封堵部20分别构造形成一盘状结构，并通过连接件连接；在一些实施方式中，支撑骨架101可以构造为图12实施方式中的单盘结构。
导管本体61上设置的电极300a通过覆膜102与支撑骨架101绝缘设置，从而避免电极300在通电状态下与支撑骨架101电导通，而出现支撑骨架101损伤待消融组织的问题。具体地，覆膜102包覆于支撑骨架101的远端。在本实施例中，覆膜102包覆锚定部10的整个外侧面。在一些实施例中，覆膜102包覆锚定部10的部分外侧面。
在一些实施例中，导管本体61上设置有显影定位件，以进一步提高对导管本体61远端部的定位效果。其中，显影结构的材料包括但不限于钽合金、铂铱合金、铂钨合金、黄金中的至少一种。
在一些实施例中，消融封堵系统1000a还包括上述实施方式所述的，设置于支撑骨架101上的用于对待消融组织进行消融的消融件50。在本实施例中，消融件50呈环形或者围成环形。消融件50设置于支撑骨架101上未被覆膜102盖的位置。具体地，消融件50设置于封堵部20上。可选地，消融件50设置于构成封堵部20的第二骨架21的近端盘面23、远端盘面24和腰部25中的至少一个位置上。
在一些实施例中，消融封堵系统1000a还包括包覆于第二骨架21的外表面的绝缘覆膜，绝缘覆膜设 置于封堵部20靠近锚定部10的远端侧，以增强第一骨架11与第二骨架21及消融件50之间的绝缘性能。消融件50设置于支撑骨架101上未被绝缘膜覆盖的位置。具体地，消融件50设置于第二骨架21的周向边缘上，且相对绝缘膜106外露。消融件50可以为额外设置于支撑骨架101上的导电件，或者是支撑骨架101的一部分。
在另一些实施例中，消融件50设置于覆膜102背离支撑骨架101的外侧面上。在这种实施例中，消融件50设置于锚定部10上，覆膜102包覆于构成锚定部10的第一骨架11的外侧面。
在其它一些实施例中，消融件50有多个，分别设置于锚定部10和封堵部20上。为了增强支撑骨架101与电极300之间的绝缘性，消融件50对应的支撑骨架101表面做绝缘处理，绝缘处理的方式具体参看前述实施例的具体描述，此处不再赘述。
在本实施例中，构成锚定部10的第一骨架11与构成封堵部20的第二骨架21一体成型，以简化制作工艺。
需要说明的是，电极300和消融件50可以同时工作，也可以不同时工作。电极300和消融件50均可以用于消融组织或标测电生理信号。
可以理解的是，图13-图14所示的实施方式中的活动导管60，也可以应用于图2所示的消融封堵装置100中，以及图11所示的消融封堵装置100g中。
下面以活动导管60应用于图2所示的消融封堵装置100中为例进行说明。
请参阅图15，图15是图1中的消融封堵系统1000b的第三实施方式的结构示意图。消融封堵装置100包括支撑骨架101与覆膜102，输送装置200包括活动导管60，活动导管60的远端设置有电极300a，电极300a用于对组织进行消融或者进行电生理信号标测。活动导管60的远端能够穿设于支撑骨架101形成的通道中，并且能够从支撑骨架101的远端伸出以用于与贴近组织，较佳地，电极300a能够贴靠在组织表面。消融或标测结束后，活动导管60的远端能够从支撑骨架101的通道中向近端移动，撤出体外。
支撑骨架101由金属材料制成，为避免电极300a与支撑骨架101相互电性耦合，覆膜102设置于支撑骨架101的外侧，即覆膜102夹设在支撑骨架101与电极300a之间的。
在本实施方式中，消融封堵装置100设置有消融件50，消融件50包括第一消融件51与第二消融件52。第一消融件51与第二消融件52间隔设置。第一消融件51与第二消融件52之间能够产生脉冲消融电场，位于一定电场强度范围内的心肌组织均会被脉冲能源消融，从而实现不可逆电穿孔，进而提高消融封堵装置100e的消融效果。
其中，第一消融件51设置于锚定部10。具体地，第一消融件51设置于覆膜102背离第一支撑骨架11的一侧。具体地，第一消融件51固定在覆膜102的外侧，并与电极300a相互间隔设置。第一消融件51可为固定设置于覆膜102外表面的导电件，比如丝状电极，如上述实施方式所述，丝状电极呈波状。第一消融件51还可以但不局限于点状电极、片状电极等。第一消融件51与电极300a用于传输相同的或不同的消融电能。可以理解的是，本实施方式中，第一消融件51为导电件的形式，即第一消融件51与电极300a均设置于覆膜102背离支撑骨架101的一侧。
在一些实施方式中，第一消融件51为部分支撑骨架，比如部分第一骨架及/或第二骨架，第一消融件51设置于支撑骨架101未被覆膜102覆盖的位置。在一些实施方式中，第二消融件52为设置于支撑骨架101上的导电件，比如设置于第一骨架及/或第二骨架。
第二消融件52设置于封堵部20。具体地，第二消融件52设置于第二骨架21的消融区段28中。第二消融件52可以为第二骨架21中位于消融区段28中的部分；或者，还可以为独立于第二骨架21之外的导电件。在一些实施例中，第二消融件52还可以设置在绝缘区段27上，且与第一骨架11及第一消融件51均间隔设置。
第一消融件、第二消融件与电极300a用于传输相同的或不同的消融电能。
在一些实施方式中，消融封堵装置100仅设置有第一消融件51，第一消融件51设置于覆膜102背离支撑骨架101的一侧。具体地，第一消融件51设置于锚定部10，且固定在覆膜102的外表面。第一消融件51与电极300a相互间隔设置。比如第一消融件51为固定设置于覆膜102外表面的丝状电极，如上述实施方式所述，丝状电极呈波状。第一消融件51与电极300a用于传输相同的或不同的消融电能。在一些实施方式中，消融封堵装置100仅设置有第二消融件52，第二消融件52设置于第二骨架21的消融区段28中。第一消融件、第二消融件与电极300a可以分别用于传输消融电能及/或采集组织的电生理信号。
需要说明的是，以上实施方式中的各种具体技术方案，在不矛盾的情况下可以相互适用。
本申请实施例提供的消融封堵系统，具有以下至少一种有益效果：
1、基于将覆膜设置于支撑骨架和电极之间，以使得电极通过覆膜与支撑骨架绝缘设置，因此在采用电极对待消融组织进行消融的过程中，电极的电能不会传输至支撑骨架，从而能够避免电极与支撑骨架直接电导通而发生短路的现象，进而确保消融封堵系统的电极消融的安全性、稳定性以及消融效果。此外，覆膜还能够组织左心耳内的血栓流出，从而避免左心耳血栓脱落后随着血液流至全身各处而导致脑栓塞 (脑卒中)、肢体动脉栓塞等问题。
2、覆膜可以直接通过浸渍或涂覆的方式直接形成在锚定盘骨架上，以制得孔隙率相对较小的覆膜，从而进一步增强支撑骨架与电极之间绝缘的可靠性和稳定性。
3、覆膜在对应电极位置以外的区域上开设有供血流通过的多个微孔，从而避免电极与支撑骨架之间在微孔处电导通而出现短路的现象。此外，微孔能够限制左心耳内的血栓从消融封堵装置内流出，从而使得左心耳与左心房中的血液形成正常的循环，且避免左心耳血栓脱落后随着血液流至全身各处而导致脑栓塞(脑卒中)、肢体动脉栓塞等问题。
以上对本申请实施例进行了详细介绍，本文中应用了具体个例对本申请的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领域的一般技术人员，依据本申请的思想，在具体实施方式及应用范围上均会有改变之处，综上上述，本说明书内容不应理解为对本申请的限制。

Claims (19)

  1. 一种消融封堵系统，其特征在于，包括：
    输送装置；
    消融封堵装置，所述消融封堵装置与所述输送装置的远端连接；所述消融封堵装置包括：
    支撑骨架，所述支撑骨架由导电材料制成；以及
    覆膜，所述覆膜包覆于所述支撑骨架外；以及
    电极，所述电极设置于所述输送装置和/或所述消融封堵装置上，且位于所述覆膜背离所述支撑骨架的一侧，所述电极通过所述覆膜与所述支撑骨架绝缘设置，所述电极用于对待消融组织进行消融。
  2. 如权利要求1所述的消融封堵系统，其特征在于，
    所述覆膜通过浸渍方式或喷涂方式直接形成于所述支撑骨架上；或者，
    所述覆膜通过浸渍方式、溶液浇铸方式、喷涂方式、流延成型方式、模压成型方式或注塑成型方式，成型后的覆膜通过缝合方式、热压方式或粘接方式固定于所述支撑骨架上。
  3. 如权利要求2所述的消融封堵系统，其特征在于，所述覆膜的孔隙率小于2.5％，所述覆膜的厚度为0.05mm-0.3mm。
  4. 如权利要求1所述的消融封堵系统，其特征在于，所述覆膜由绝缘材料制成；或者，所述覆膜的内侧面和/或外侧面均设置有绝缘涂层。
  5. 如权利要求4所述的消融封堵系统，其特征在于，所述覆膜的材料包括绝缘材料，所述绝缘材料包括聚酰亚胺、聚砜、聚迷砜树酯、聚乙烯吡咯烷酮、聚甲基丙烯酸甲酯、氢化苯乙烯-丁二烯嵌段共聚物、热塑性聚氨酯弹性体、聚氨酯、聚对二甲苯和硅橡胶中的至少一种。
  6. 如权利要求4所述的消融封堵系统，其特征在于，所述覆膜的材料包括绝缘的可降解材料，所述绝缘的可降解材料为聚乳酸、聚己内酯中的一种或者几种聚合物的共聚物或共混物。
  7. 如权利要求1所述的消融封堵系统，其特征在于，所述电极设置于所述覆膜背离所述支撑骨架的外侧面上。
  8. 如权利要求7所述的消融封堵系统，其特征在于，所述电极与所述覆膜及所述支撑骨架固定连接；或者，所述电极与所述覆膜固定连接。
  9. 如权利要求1所述的消融封堵系统，其特征在于，所述输送装置包括活动导管，所述支撑骨架上沿轴向贯穿设置有通道，所述活动导管活动地穿设于所述通道，所述活动导管包括导管本体，所述电极设置于所述导管本体远端，所述活动导管的远端用于在所述支撑骨架的远端侧释放。
  10. 如权利要求1-9任意一项所述的消融封堵系统，其特征在于，所述支撑骨架包括承载区段，所述电极对应所述承载区段设置，所述支撑骨架对应所述承载区段的表面设置有绝缘涂层或绝缘套管。
  11. 如权利要求1-9任意一项所述的消融封堵系统，其特征在于，所述消融封堵系统包括设置于所述支撑骨架上的用于对待消融组织进行消融的消融件，所述消融件与所述电极间隔设置；所述消融件设置于所述覆膜背离所述支撑骨架的外侧面上；或者，设置于所述支撑骨架上未被所述覆膜覆盖的位置。
  12. 如权利要求1-9任意一项所述的消融封堵系统，其特征在于，所述支撑骨架上设置有多个锚刺，所述多个锚刺沿所述支撑骨架的外表面的周向间隔设置，所述多个锚刺相对所述覆膜外露，所述多个锚刺与所述电极错开设置。
  13. 如权利要求12所述的消融封堵系统，其特征在于，所述多个锚刺均设置在所述电极的同一侧。
  14. 如权利要求11所述的消融封堵系统，其特征在于，所述支撑骨架上设置有多个锚刺，所述多个锚刺沿所述支撑骨架的外表面的周向间隔设置，所述多个锚刺相对所述覆膜外露，所述消融件与所述多个锚刺分别设置于所述电极的两侧。
  15. 如权利要求11所述的消融封堵系统，其特征在于，所述消融件为部分所述支撑骨架，或者为额外设置于所述支撑骨架上的导电件。
  16. 如权利要求11所述的消融封堵系统，其特征在于，所述支撑骨架包括锚定部以及设置于所述锚定部近端的封堵部，所述电极设置于所述锚定部，所述消融件设置于所述封堵部。
  17. 如权利要求16所述的消融封堵系统，其特征在于，所述锚定部与所述封堵部相互绝缘。
  18. 如权利要求17所述的消融封堵系统，其特征在于，所述支撑骨架包括绝缘连接件，所述锚定部及所述封堵部通过所述绝缘连接件连接且电隔离。
  19. 如权利要求1-11任意一项所述的消融封堵系统，其特征在于，所述消融封堵装置为左心耳消融封堵装置，所述支撑骨架用于植入至左心耳的缺口处，所述覆膜包覆于所述支撑骨架的远端，所述覆膜在对应所述电极位置以外的区域上开设有供血流通过的多个微孔，每一个所述微孔的尺寸小于0.25mm。
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