WO2019166017A1 - 左心耳封堵消融装置 - Google Patents

左心耳封堵消融装置 Download PDF

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Publication number
WO2019166017A1
WO2019166017A1 PCT/CN2019/076749 CN2019076749W WO2019166017A1 WO 2019166017 A1 WO2019166017 A1 WO 2019166017A1 CN 2019076749 W CN2019076749 W CN 2019076749W WO 2019166017 A1 WO2019166017 A1 WO 2019166017A1
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WIPO (PCT)
Prior art keywords
ablation
left atrial
atrial appendage
electrode
anchor
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PCT/CN2019/076749
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English (en)
French (fr)
Inventor
唐闽
张澍
王永胜
李建民
吴俊飞
丘家明
Original Assignee
诺芮医疗器械（上海）有限公司
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Priority claimed from CN201810176186.4A external-priority patent/CN110215254A/zh
Priority claimed from CN201810176184.5A external-priority patent/CN110215253A/zh
Application filed by 诺芮医疗器械（上海）有限公司 filed Critical 诺芮医疗器械（上海）有限公司
Publication of WO2019166017A1 publication Critical patent/WO2019166017A1/zh

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    • 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

Definitions

  • the invention belongs to the technical field of medical instruments, and particularly relates to a left atrial appendage ablation and ablation device, which uses a percutaneous puncture method to transport it to a position of a left atrial appendage of a heart through a delivery catheter, and can simultaneously block the left atrial appendage and Ablation.
  • Atrial fibrillation is the most common persistent arrhythmia. As you age, the incidence of atrial fibrillation increases, reaching 10% in people over 75 years of age. The prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure. Because of its special morphology and structure, the left atrial appendage is not only the most important part of thrombosis of atrial fibrillation, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can benefit from active left atrial electrocardiogram isolation.
  • Radiofrequency ablation is one of the hotspots of atrial fibrillation today.
  • radiofrequency ablation can improve atrioventricular node or completely ablate atrioventricular node into a pacemaker to control ventricular rate; linear ablation or ablation of pulmonary veins in the atrium (including point ablation, segmental ablation, and ablation) Ablation) to prevent recurrence of atrial fibrillation.
  • radiofrequency ablation is still the main surgical procedure for atrial fibrillation, the main purpose of this procedure is to improve the symptoms of palpitations, chest tightness and other symptoms, improve heart function, and some patients have radiofrequency ablation surgery due to thromboembolism. Success also requires lifelong anticoagulation to solve the problem of thromboembolism. Patients need to take oral anticoagulant drugs after ablation, which increases the financial burden of patients and also reduces the quality of life of patients.
  • the left atrial appendage can be blocked with a left atrial appendage occluder, which is a less invasive, simpler and less time-consuming treatment developed in recent years.
  • Today's left atrial appendage occlusion device is mainly made of an expandable polymer film on the outer bread of the self-expanding nickel-titanium memory alloy cage structure support, and the occluder is placed in the left atrial appendage for sealing.
  • the polymer film can seal the atrial entrance of the left atrial appendage, and isolate the left atrial appendage and the left atrium to prevent blood flow.
  • the left atrial endothelial cells crawl and grow on the surface of the polymer membrane, forming a new endothelium after a period of time.
  • simple left atrial appendage occlusion device can only play a role in stroke prevention, but it can not improve the symptoms of atrial fibrillation.
  • Atrial fibrillation treatment From the overall height of atrial fibrillation treatment, restoring sinus rhythm and stroke prevention are two parallel treatment strategies, and their importance is no different.
  • many successful treatments for atrial fibrillation have been made using the combined catheter radiofrequency ablation and left atrial appendage closure.
  • the left atrial appendage occlusion compared with a single oral anticoagulant or atrial fibrillation ablation, patients can still achieve good stroke prevention without taking lifelong anticoagulant drugs;
  • Ablation restores and maintains sinus rhythm and improves the symptoms of patients with atrial fibrillation, which can provide patients with stable long-term therapeutic effects.
  • the current ablation methods are mainly: ablation of the atrial fibrillation outside the pulmonary vein by pulmonary vein isolation (PVI).
  • the technical problem to be solved by the present invention is that the radio frequency ablation and the blocking are independently performed for the prior art, wherein the radio frequency ablation operation is difficult and takes a long time, and there may be a situation that cannot be completely isolated, and it is difficult to maintain the long-term therapeutic effect.
  • An improved left atrial appendage occlusion device is provided in conjunction with atrial fibrillation ablation and stroke prevention.
  • a left atrial appendage ablation device comprising a seal at the proximal end for closing the left atrial appendage, an anchor at the distal end for anchoring the device in the left atrial appendage, and a wall for the left atrial appendage
  • An ablation member for performing annular ablation; the ablation member includes an electrode and an annular skeleton for adhering to an inner wall to be ablated by the left atrial appendage, the electrode being electrically connected to the radio frequency source.
  • At least one ring electrode is disposed on the annular outer wall surface of the annular skeleton of the ablation member, and the electrode is electrically connected to the radio frequency source through the annular skeleton.
  • the sealing member is provided with a connecting end, and the connecting end is electrically connected to the electrode of the ablation member and the radio frequency source, respectively.
  • the connecting end is disposed at a center of a proximal end surface of the sealing member, and the connecting end is electrically connected to an electrode of the ablation member through a mesh skeleton of the sealing member;
  • the center of the seal is provided with a transition piece for the connection end to be electrically connected to the electrode of the ablation member.
  • the annular skeleton is not insulated at the portion in contact with the electrode, and the remaining portion is insulated at least on the outer surface of the anchor.
  • the electrode is directly electrically connected to a radio frequency source; at least a portion of the ablation member that is in contact with the electrode is insulated.
  • the sealing member is provided with a sealing surface that is in contact with the inner wall of the left atrial appendage.
  • the sealing member, the ablation member and the anchoring member are integrated;
  • sealing member and the ablation member are integrally formed, and the ablation member and the anchor member are connected by a connecting member;
  • sealing member and the ablation member are connected by a connecting member, and the ablation member and the anchoring member are integrally formed;
  • the sealing member is a sealing disk formed by a metal mesh skeleton
  • the sealing member is a sealing plug formed by the metal mesh skeleton
  • the seal is a sealing plug formed by the metal mesh skeleton, the sealing plug including a disk surface facing away from the ablation member, a disk bottom facing the ablation member, and connecting the disk surface and the disk The bottom of the waist.
  • the mesh skeleton is coated with an insulating coating at least on a sealing surface that is attached to the left atrial appendage;
  • the mesh skeleton is made of a wire or a metal rod, and at least the wire or metal rod at the sealing surface is sheathed with an insulating sleeve.
  • the annular outer wall surface of the annular skeleton is continuously or intermittently provided with a single-turn electrode or a multi-turn electrode, and the coil electrodes of the multi-turn electrode are parallel in the axial direction of the annular skeleton Arranged or staggered.
  • the electrode is a ring electrode that is independently looped around the annular skeleton
  • the electrode is formed by a plurality of single electrodes in a ring structure in which the plurality of single electrodes are continuously arranged or spaced apart in the circumferential direction of the annular skeleton.
  • the electrode and the annular skeleton are connected by stitching, welding, winding or steel sleeve.
  • the annular skeleton is at least one of a mesh structure, a rod structure or a frame structure made by weaving or cutting.
  • the anchoring member includes an anchoring body, and a plurality of anchor thorns are disposed at a side of the anchoring body at a time, and the anchor thorn extends toward the outer side of the proximal end.
  • the anchor is electrically conductive at least on the outer surface and electrically connected to the radio frequency source.
  • the anchor body is a cylindrical structure, at least one end of the distal end and the proximal end of the anchor body is closed; or the distal end of the anchor of the cylindrical structure and The proximal end is open.
  • the anchoring body is a folded structure, and the folding structure is extended outward from the center of the distal end of the ablation member, and is formed by gradually folding back.
  • the anchor is evenly arranged on the outer wall of the folded structure.
  • the folded structure is gathered toward the center after folding, forming a proximally closed or approximately closed anchoring body;
  • the folded structure does not converge toward the center after folding, forming an anchoring body with a proximal opening.
  • the metal mesh skeleton of the anchor body is coated with an insulating coating at least on an outer wall surface that is attached to the left atrial appendage;
  • an insulating film is disposed at least outside the outer wall surface of the metal mesh skeleton
  • the metal mesh skeleton is made of a wire or a metal rod, and the metal mesh skeleton is at least in the wire or the inner wall surface of the left atrial appendage
  • the metal rod is covered with an insulating sleeve.
  • At least one of the radial members is provided with a blocking member for closing the left atrial appendage.
  • the barrier member is at least one baffle film disposed at least radially inside the sealing member, and the baffle film is laterally disposed and fixed on the inner wall;
  • the barrier member is a laterally closed insulating film disposed at least at a proximal end and/or a distal end of the seal;
  • the barrier member is a laterally closed insulating film disposed at least at the distal end and/or the proximal end of the anchor.
  • the proximal end of the left atrial appendage ablation device is provided with a sealing member for sealing the passage between the left atrial appendage and the left atrium to prevent the left atrial appendage from entering the left atrium; the distal end is provided with an anchoring member, which can block the entire left atrial appendage.
  • the device is firmly fixed in the left atrial appendage; at the same time, an ablation member is disposed between the seal and the anchor near the entrance of the left atrial appendage or the entrance of the left atrial appendage, the electrode of the ablation member ablating the position of the inner wall near the entrance of the left atrial appendage, increasing The success rate of atrial fibrillation ablation; and because of the ablation through the electrodes, the electrodes are electrically connected to the RF power source, which can greatly improve the efficiency of ablation.
  • These three parts cooperate to achieve atrial fibrillation ablation and stroke prevention.
  • the implantation operation is simple and reliable, easy to use, and has no significant influence on the existing surgical methods and operation time.
  • FIG. 1 is a schematic structural view of a left atrial appendage ablation device of Embodiment 1;
  • Figure 2 is a plan view of Embodiment 1;
  • FIG. 3 is a schematic view showing the release of the left atrial appendage ablation device to the left atrial appendage of Embodiment 1;
  • FIG. 4 is a schematic structural view of another embodiment of the left atrial appendage plug ablation device of Embodiment 1;
  • FIG. 5 is a schematic structural view of another embodiment of a left atrial appendage plug ablation device of Embodiment 1;
  • FIG. 6 is a schematic structural view of another embodiment of the left atrial appendage plug ablation device of Embodiment 1;
  • FIG. 7 is a schematic structural view of another embodiment of a left atrial appendage ablation device of Embodiment 1;
  • FIG. 8 is a schematic structural view of a left atrial appendage ablation device of Embodiment 2;
  • FIG. 9 is a schematic structural view of another embodiment of a left atrial appendage plug ablation device of Embodiment 2;
  • FIG. 10 is a schematic structural view of a left atrial appendage ablation device of Embodiment 3;
  • Figure 11 is a schematic view showing the structure of the distal end of the anchoring member of the left atrial appendage ablation device of Example 3;
  • FIG. 12 is a schematic structural view of a left atrial appendage ablation device of Embodiment 4.
  • FIG. 13 is a schematic structural view of a left atrial appendage ablation device of Embodiment 5;
  • Figure 14 is a schematic view showing the structure of the distal end of the anchoring member of the left atrial appendage ablation device of Example 5;
  • FIG. 15A to FIG. 15B are schematic diagrams showing the release of the left atrial appendage ablation device to the left atrial appendage according to Embodiment 5;
  • FIG. 16 is a schematic structural view of a left atrial appendage ablation device of Embodiment 6;
  • FIG. 17 is a schematic structural view of another embodiment of a left atrial appendage ablation device of Embodiment 6;
  • FIG. 18 is a schematic structural view of a left atrial appendage ablation device of Embodiment 7;
  • FIG. 19 is a schematic structural view of another embodiment of a left atrial appendage ablation device of Embodiment 7;
  • FIG. 20 is a schematic structural view of another embodiment of a left atrial appendage ablation device of Embodiment 7;
  • FIG. 21 is a schematic structural view of an anchor of another embodiment of the left atrial appendage plug ablation device of Embodiment 7;
  • FIG. 22 is a schematic structural view of another embodiment of a left atrial appendage plug ablation device of Embodiment 7;
  • FIG. 23 is a schematic structural view of a left atrial appendage ablation device of Embodiment 8.
  • FIG. 24 is a schematic structural view of a left atrial appendage ablation device of Embodiment 9;
  • Figure 25 is a plan view of Embodiment 9;
  • Figure 26 is a schematic view showing the release of the left atrial appendage ablation device to the left atrial appendage of Example 9;
  • FIG. 27 is a schematic structural view of another embodiment of a left atrial appendage ablation device of Embodiment 9;
  • FIG. 28 is a schematic structural view of another embodiment of a left atrial appendage plug ablation device of Embodiment 9;
  • FIG. 29 is a schematic structural view of another embodiment of the left atrial appendage plug ablation device of Embodiment 9;
  • FIG. 30 is a schematic structural view of another embodiment of the left atrial appendage ablation device of Embodiment 9.
  • the distal end and the proximal end of the present invention are relative to the operator.
  • the end of the occlusion device closer to the operator is the proximal end, and the end remote from the operator is the distal end.
  • the axial direction of the device refers to the direction of the axis of the device, the radial direction is perpendicular to the central axis, and the circumferential direction is about the axis of the cylinder (simultaneously perpendicular to the axial and radial directions).
  • the left atrial appendage in the present application includes a portion connecting the left atrial appendage and the left atrium, in addition to the inside of the left atrial appendage.
  • a left atrial appendage ablation device includes a seal member 110 at the proximal end for closing the left atrial appendage, and an anchor member 130 at the distal end for anchoring the device in the left atrial appendage; Also included is an ablation device 120 for annular ablation of the inner wall of the left atrial appendage, wherein the ablation member 120 is provided with an electrode 122 and an annular skeleton 121 for abutting the inner wall of the left atrial appendage, the electrode 122 and the radio frequency source Electrically connected, the annular frame 121 is not insulated at the portion in contact with the electrode 122 throughout the apparatus, and the remainder is insulated at least on the outer surface of the anchor member 130.
  • the remaining portion includes the seal 110, a portion of the ablation member 120 that is not in contact with the electrode, and an anchor 130.
  • the function of the sealing member 110 is to block the left atrial body and the left atrial appendage to prevent the left atrial appendage from entering the left atrium.
  • the sealing member 110 is provided with a sealing surface that is insulative and insulated from the left atrial appendage or/and the left atrial appendage inner wall.
  • the anchor 130 can securely fix the entire left atrial appendage ablation device in the left atrial appendage; the ablation member 120 is disposed between the seal and the anchor and near the left atrial appendage or left atrial appendage after implantation At the entrance; ablation of the left atrial appendage entrance or nearby inner wall by the electrode 122 disposed thereon increases the healing success rate of atrial fibrillation ablation.
  • the sealing member 110, the ablation member 120 and the anchoring member 130 are integrally formed; the integral structure may be a structure directly fixed by welding or the like, or may be an integral structure formed by integral molding. .
  • the second embodiment the sealing member 110 and the ablation member 120 are integrally formed, and the ablation member 120 and the anchor member 130 are connected by the connecting member 30; likewise, the integral structure may be directly fixed by welding or the like.
  • the structure can also be an integral structure made in one piece.
  • the function of the connecting member 30 is to connect the ablation member 120 with the anchoring member 130. Therefore, the structure of the connecting member 30 is not limited, and may be any shape according to the structure of the ablation member 120 and the anchor member 130, for example, in ablation.
  • a plurality of axially disposed connecting rods, or connecting rods disposed in the axial center, or a metal mesh or the like are used between the member 120 and the anchor member 130.
  • the third embodiment the sealing member 110 and the ablation member 120 are connected by the connecting member 30, and the ablation member 120 and the anchoring member 130 are integrally formed; the connecting structure in the embodiment is the same as the second embodiment, This will not be repeated here.
  • the fourth embodiment the sealing member 110 and the ablation member 120, and the ablation member 120 and the anchor member 130 are respectively connected by a connecting member 30.
  • the structure of the connecting member 30 is the same as above, and details are not described herein again.
  • the device of the present invention is to be placed in the left atrial appendage, and the shape of the device is matched with the shape of the left atrial appendage, which is an axisymmetric structure, and the cross section in the radial direction is circular or approximately circular. Because the three parts are connected differently, the shape of the three is different, that is, when the ablation position is determined in the left atrial appendage, the other components are set according to the position of the ablation member 120, if the ablation member 120 and the sealing member 110 are The connecting member 30 is disposed to lengthen the distance between the two, and the sealing position of the sealing member 110 is at the left atrial appendage entrance.
  • the diameter of the sealing member 110 is larger than the diameter of the ablation member 120, and the ablation member 120 and the sealing member 110 are integrally formed, and the sealing member is The sealing position of 110 is in the left atrial appendage, and the diameter of the sealing member 110 is the same as or slightly larger than the diameter of the ablation member 120.
  • the anchoring body shape of the anchor 130 is such that the anchor stud disposed on the anchoring body 131 can be anchored into the left atrial appendage.
  • the main body of the sealing member 110 is a mesh skeleton 111.
  • the mesh skeleton 111 may be woven by wire or may be formed by cutting a metal tube to form a mesh frame structure.
  • the shape of the sealing member 110 may be a stepped shape formed by a combination of a disk shape, a cylindrical shape, a disk shape and a cylindrical shape.
  • the size and shape of the mesh in the mesh skeleton 111 are set according to actual needs, and the present invention is not limited.
  • the sealing member 110 is a sealing disk formed by the mesh skeleton 111 for sealing the left atrial appendage inlet, and the sealing disk is conformed to the shape of the left atrial appendage inlet; Wherein, the sealing member 110 is pressed against the entrance of the left atrial appendage, the diameter of the sealing member 110 is slightly larger than the inner diameter of the left atrial appendage, and the sealing member 110 adopts a disc-like structure having a short axial length, and the disc-shaped structure can directly press the inlet.
  • the sealing member 110 is a sealing plug formed by the mesh skeleton 111 for sealing the left atrial appendage neck, and the sealing plug conforms to the shape of the left atrial appendage neck;
  • the sealing member 110 is inserted into the left atrial appendage neck of the left atrial appendage, the diameter of the sealing member 110 is identical to the inner diameter of the left atrial appendage, and the sealing member 110 has a cylindrical structure.
  • a third embodiment of the seal 110 is a sealing plug formed by the mesh skeleton 111 for simultaneously sealing the left atrial appendage and the left atrial appendage, the sealing plug and the left atrial appendage
  • the shape of the neck and the left atrial appendage are consistent.
  • the proximal end of the sealing member 110 is in the shape of a disk, the telecentric end is cylindrical or the diameter is gradually reduced, and the diameter of the disk-shaped portion is larger than the diameter of the cylindrical or truncated portion.
  • the diameter of the disc-shaped portion of the sealing member 110 at the entrance of the left atrial appendage is slightly larger than the inner diameter of the left atrial appendage, and the diameter of the cylindrical or circular-shaped portion of the sealing member 110 inserted into the left atrial appendage is identical to the inner diameter of the left atrial appendage.
  • the main structure of the sealing member 110 is a mesh skeleton 111. Therefore, for better sealing, it is preferable that the sealing member 110 is provided with a blocking member, and the blocking member disposed on the sealing member 110 can be provided in two different ways: one is set in the sealing Inside the member 110, one is disposed at the proximal end or/and the telecentric end of the seal member 110.
  • a choke film can be used internally, and a choke film or/and an insulating film can be used at the near-center or/and the telecentric end.
  • the main function of the sealing member 110 is to seal. Since the ablation member 120 is released earlier than the sealing member 110, the ablation member 120 can be ablated after releasing the ablation member 120. After completion, the power supply is cut off and the sealing member 110 is released. Therefore, the sealing member 110 can be Not insulated.
  • the sealing member 110 When the sealing member 110 is released before ablation, it is preferable to perform an insulation treatment, and the following different embodiments may be adopted depending on the insulation method:
  • the first embodiment of the sealing member 110 is insulated: the mesh frame 111 of the sealing member 110 is coated with an insulating coating at least on the sealing surface that is attached to the left atrial appendage; the sealing surface refers to the wall surface of the sealing member 110 that is in contact with the atrial appendage. At least the sealing surface is coated with an insulating coating, which means that at least the outer peripheral wall surface of the sealing member 110 is coated with an insulating coating, and the insulating coating is formed by coating with an insulating material to form one or more layers on the mesh skeleton 111. Insulating material, the isolated mesh skeleton 111 is in conductive contact with the left atrial appendage.
  • a second embodiment in which the sealing member 110 is insulated an outer surface of the mesh frame 111 is provided with an insulating film at least at the sealing surface; the insulating film can be fixed outside the mesh frame 111 by stitching, hot pressing, spraying, dipping or the like.
  • the surface forms a sealing surface, or the inner and outer surfaces of the mesh skeleton 111 are simultaneously fixed with an insulating film, and the insulating film may be made of FEP, ETFE, PFA, PTFE, or silica gel material.
  • the mesh frame 111 is made of a wire or a metal rod, and at least the wire or metal rod at the sealing surface is sheathed with an insulating sleeve.
  • the insulating sleeve is made of FEP, ETFE, PFA, PTFE and other materials.
  • the mesh frame 1110 is insulated from the inner wall of the left atrial appendage by being worn outside the wire or metal rod.
  • the insulation of the sealing member 110 may also be a combination of the above two methods, for example, the first insulating coating combined with the second fixed insulating film; or the third through-insulating sleeve combined with the second fixed insulating film.
  • the proximal end of the seal 110 is provided with a connection end 113 detachably connected to the conveyor.
  • the connecting end 113 is disposed at the center of the proximal end face of the sealing member 110.
  • the connection end 113 is electrically coupled to the RF source through a delivery lead within the conveyor and transmits RF energy to the electrode 122 of the ablation member 120 through the conductive backbone of the occlusion device.
  • the ablation member 120 Since the ablation member 120 performs annular ablation on the inner wall of the left atrial appendage, the ablation member 120 includes an annular skeleton 121 and an electrode 122 that are attached to the inner wall of the left atrial appendage, and the annular skeleton 121 is a wire made of braided or cut. At least one of the mesh, the metal rod, and the metal mesh frame, that is, the annular skeleton 121 is annular, and may be formed by meshing the wires to form a grid shape that intersects each other, or may be a fence shape in which metal rods are arranged in parallel with each other. It may be a spiral or the like which is capable of radially contracting and stretching.
  • the electrode 122 on the ablation member 120 is disposed on the annular frame 121 in two ways.
  • the annular outer wall surface of the annular frame 121 is continuously provided with one electrode 122, and the electrode 122 is arranged in a single manner.
  • Circle electrode or multi-turn electrode is provided with a ring of electrodes 122 along a ring-shaped outer wall surface of the annular frame.
  • the multi-turn electrode is provided with at least two turns of the electrode 122 along a ring-shaped outer wall surface of the annular frame, and the adjacent two-turn electrodes 122 are arranged side by side or spaced apart in the axial direction of the annular frame.
  • the continuous arrangement of the electrodes 122 is also divided into two embodiments, one of which is an annular structure in which the electrodes 122 are continuously arranged in a circumferential direction of the annular skeleton by a plurality of single electrodes.
  • the other is that the electrode 122 is a ring electrode that is looped independently around the annular skeleton.
  • the annular outer wall surface of the annular skeleton is intermittently provided with a single-turn electrode or a multi-turn electrode, and the electrode 122 in the single-turn electrode or the multi-turn electrode is in a ring shape by a plurality of single electrodes.
  • the coil electrodes 122 of the multi-turn electrode are arranged in parallel or staggered in the axial direction of the annular skeleton.
  • the shape of the single electrode may be selected from the group consisting of a dot shape, a rod shape, a sheet shape, and the like, and the ring electrode is a discontinuous or uninterrupted annular structure, and the electrode 122 has an axial length of between 1 mm and 12 mm.
  • the electrode 122 and the annular skeleton 121 are connected by sewing, welding, winding or steel sleeve.
  • the anchoring member 130 includes an anchoring body 131, and a plurality of anchor thorns are disposed at a side of the anchoring body 131 at a side, and the anchor thorn extends toward the outer side of the proximal end.
  • a first embodiment of the anchor member 130 the anchoring body 131 is a cylindrical structure, and the anchor thorn is uniformly disposed on one outer circumference of the cylindrical structure. At least one of the distal end and the proximal end of the anchoring body 131 of the cylindrical structure is closed; or the distal end and the proximal end of the anchor 130 of the cylindrical structure are both open.
  • a second embodiment of the anchoring member 130 is: the anchoring body 131 is a folded structure, and the folding structure is extended from the center of the distal end of the ablation member 120 toward the outer side in the telecentric direction, and is gradually folded in reverse.
  • the anchor is evenly disposed on the outer wall of the folded structure.
  • the folded structure is gathered toward the center after folding, forming a proximally closed or approximately closed anchoring body 131; or the folded structure does not converge toward the center after folding, forming a proximally open anchoring body 131 .
  • the anchoring body 131 of the anchoring member 130 is coated with an insulating coating at least on the outer wall surface that is fitted to the left atrial appendage; or at least the anchoring body 131 is externally
  • An insulating film is disposed at the outer wall surface; or the anchoring body 131 is made of a wire or a metal rod, at least at the wire or metal rod that fits at or near the inner wall surface of the left atrial appendage
  • the insulating structure of the above embodiment is the same as the sealing member 110, and details are not described herein again.
  • the anchoring member 130 is provided with a plurality of anchors 133 for anchoring on the inner wall of the left atrial appendage.
  • the anchors 133 are disposed on the outer wall surface of the anchoring body 131, and are uniformly disposed along the outer wall surface of the anchoring body 131. According to different ways of setting anchor 133, there are several implementation methods:
  • the first embodiment of the anchor 133 is connected to the anchor 130: the anchor 133 can be directly fixed on the anchor body 131, and the fixing manner is welding or the like;
  • a second embodiment in which the anchor 133 is coupled to the anchor 130 the anchor 133 can also be fixedly coupled to the anchor 130 by a steel sleeve.
  • the anchor thorns 133 are arranged in a number of 6-9, the anchor 133 opening angle is between 30° and 60°, the direction is toward the proximal end, and the anchor 133 is between 0.5 and 4 mm in length.
  • the anchor 133 is electrically conductive and electrically connected to the radio frequency source, and the barb 133 can be electrically connected to the radio frequency source through the connecting end of the anchor 130, and the anchor 133 can be in contact with the left atrial appendage. Ablation.
  • the ablation member 120 and the anchor member 130 in addition to the at least one blocking membrane 112 for blocking the thrombus inside the sealing member 110, the ablation member 120 or
  • the blocking film 122 and the blocking film 132 are disposed in the anchoring member 130.
  • the periphery of the blocking film 1120, 122, 132 is fixed in the interior of the blocking film 1120, 122, 132 by a plurality of stitching points, and the blocking film 1120, 122, 132 can be PET or PTFE film.
  • the number and position of the choke films 112, 122, 132 are set to 1-5 depending on actual needs.
  • the sealing member 110 and the surface of the anchoring member 130 are treated with an insulating coating and a suture blocking film 112. First, the thrombus in the left atrial appendage can be blocked from entering the left atrium, and the ablation resistance of the acupuncture ablation device can be improved.
  • the entire left atrial appendage blocks the conductive contact surface area of the ablation device with blood and tissue, avoiding excessive energy loss at the blood or non-target tissue, thereby concentrating energy for tissue radiofrequency ablation at the corresponding target point of the ablation member 120, and Decreasing the damage of the ablation process to the tissue of the non-ablative region;
  • the ablation member 120 includes an annular skeleton 121 and an electrode 122 connected thereto, the structure is adapted to the structure of the left atrial appendage, and is closely attached to the targeted ablation region to realize the left atrial appendage
  • the inner wall of the inner part is densely ablated and multi-point ablation, which greatly improves the success rate of ablation and shortens the operation time.
  • the anchor 133 of the anchoring member 130 is made of a metal material, and is mainly used to strengthen the structure of the left atrial appendage ablation device in the left atrial appendage.
  • the internal position can also be used for ablation, and the electrode 122 of the ablation member 120 performs a dual ablation function.
  • the electrical connection of the electrode 122 on the ablation member 120 to the RF source includes two modes:
  • the first type of electrical connection is by providing a connection end 113 on the sealing member 110, the connection end 113 being electrically connected to the electrode 122 of the ablation member 120 and the radio frequency source, respectively.
  • the connecting end 113 is a tip end structure formed by the converging of the wires of the sealing member 110, and may be additionally fixed to the end surface structure of the sealing member 110.
  • the connecting end is disposed at the center of the proximal end of the sealing member 110, and the connecting end 113 is electrically connected to the electrode 122 of the ablation member 120 in two ways: one is that the connecting end 113 passes through the mesh skeleton 111 of the sealing member 110 and ablate The electrode 122 of the member 120 is electrically connected; the second is that the seal member 110 is provided with a transition piece at the center for electrically connecting the connection end to the electrode 122 of the ablation member 120.
  • the second electrical connection mode is that the electrode 122 is directly connected to the RF source, that is, the RF source and the electrode are directly connected by a wire, and the current is not transmitted through other parts of the ablation device; in order to concentrate the RF energy on the electrode 122
  • the face that conforms to the inner wall of the left atrial appendage is not conducted to the other portion of the ablation device by contact of the electrode 122 with the annular skeleton 121 of the ablation member, and the portion of the ablation member 120 that is in contact with at least the electrode 122 is insulated.
  • the electrode 122 is used in the ablation member 120 for ablating the inner wall of the left atrial appendage, and other portions of the ablation member 120 mainly serve as a support.
  • the ablation member 120 includes an annular frame 121 that supports the inner wall of the left atrial appendage for one week.
  • the annular outer wall surface of the annular frame 121 is provided with an electrode 122.
  • the connection mode of the electrode 122 is a direct connection.
  • the electrode 122 is directly connected to a radio frequency source.
  • the left atrial appendage ablation device is composed of three parts: a sealing member 110, an ablation member 120, and an anchor member 130.
  • the sealing member 110 is located in the proximal end region of the device, and further includes a mesh frame 111, one or more layers of the baffle film 112 and the connecting end 113; the blocking film 112 is fixed in the mesh frame 111 by stitching, and is blocked.
  • the flow film 112 may be selected from a PET or PTFE film; the connection end 113 is located at the center of the proximal end face, and a bolt head is preferably used, and a connection wire is connected through the connection end 113, and the transmission wire can transmit the RF source of the RF source through the connection end 113. Energy is delivered to the electrode 122 of the ablation device 120.
  • the sealing member 110 , the ablation member 120 and the anchoring member 130 are integrally formed, that is, the mesh skeleton 111 of the sealing member 110 , the annular skeleton 121 of the ablation member 120 , and
  • the anchoring body 131 of the anchoring member 130 is a unitary structure, and the sealing member 110, the ablation member 120 and the anchoring member 130 have the same diameter, and the integral device exhibits a round plug structure.
  • the wire is woven into a sealing member 110, and the ablation member 120 and the anchoring member 130 are integrally formed into three parts, and then formed.
  • the connecting end 113 disposed on the sealing member 110 is bundled with the metal frame at the proximal end surface.
  • the head end; the head 134 converges the distal end of the metal frame head end of the anchor member 130, as shown in FIG.
  • the braided wire of this embodiment may be a nickel titanium alloy, a cobalt chromium alloy, a stainless steel or other metal material having good biocompatibility.
  • the superelastic shape memory alloy nickel-titanium wire is preferred, and the manufacturing process thereof is the same as that of the conventional left atrial appendage occluder, and will not be described herein.
  • the integral structure of the sealing member 110, the ablation member 120 and the anchoring member 130 may also be a structure directly fixed together by welding or the like.
  • the sealing member 110 is a sealing plug formed by the mesh skeleton 111 for sealing the left atrial appendage neck, and the sealing plug is matched with the shape of the left atrial appendage neck; in this embodiment, the sealing member 110 is inserted into the left atrial appendage.
  • the diameter of the sealing member 110 coincides with the inner diameter of the left atrial appendage, and the sealing member 110 has a cylindrical structure, and the outer wall surface of the cylindrical structure is a sealing surface.
  • the sealing member 110 encloses the left atrial appendage through a baffle 112 disposed therein.
  • the periphery of the baffle film 112 is fixed inside the mesh skeleton 111 by a plurality of stitching points by a stitching method, and the choke film 112 may be a PET or PTFE film.
  • the ablation member 120 is located in an intermediate portion of the three, and the ablation member 120 includes an annular skeleton 121 that is attached to the inner wall of the left atrial appendage for a week.
  • the annular skeleton 121 is the main body of the ablation member 120.
  • the structure is formed by weaving a wire into a grid pattern that intersects each other.
  • the connecting electrode 122 is fixed on the annular frame 121.
  • the electrode 122 can be fixed on the annular frame 121 by stitching, welding, winding or steel sleeve, and the electrode 122 is connected to the connecting end 113 through the annular frame 121 to be electrically connected to the RF source. .
  • the electrode 122 selects a single-turn electrode
  • the single-turn electrode may select a ring structure formed by continuously arranging a plurality of single electrodes in the circumferential direction of the annular skeleton, or may be a ring that is independently looped around the annular skeleton.
  • Electrode this embodiment selects a ring electrode.
  • the axial length of the electrode 122 is between 1 and 12 mm, preferably 5 mm in this embodiment. As shown in FIG. 1, one or more layers of the flow blocking film 123 may also be disposed in the ablation member 120.
  • the anchoring member 130 is located at the distal end of the device, and includes an anchoring body 131, a blocking film 132, an anchor 133 and a head 134; the anchoring body 131 is a cylindrical structure.
  • the cylindrical structure that is, the diameter of the anchor 130 is substantially the same as the inner diameter of the left atrial appendage, and the contact between the outer wall surface of the anchor 130 and the inner wall of the left atrial appendage forms a frictional force, and the anchor 130 can be directly used for anchoring.
  • the anchor body 131 of the anchor 130 is provided with a plurality of anchors 133 for anchoring on the inner wall of the left atrial appendage, and the anchors 133 are evenly arranged on the outer wall of the tubular structure, after the device is implanted, The anchor thorn penetrates into the inner wall of the left atrial appendage and anchors it with anchor thorn anchoring stability.
  • the distal end of the anchoring body 131 of the tubular structure is closed, and the proximal end is integrally connected with the ablation member 120.
  • At least one baffle film 132 is disposed in the anchor body 131, and the periphery of the baffle film 132 is fixed to the inside of the anchor body 131 by a suture method, such as a PET or PTFE film.
  • the anchor 133 and the anchor body 131 are a unitary structure or a fixed connection structure.
  • the anchor 133 is connected to the anchor body 131 by using a steel sleeve 135, and the position is at the distal end of the anchor 130, and the number is 6-
  • the anchor 133 opening angle is between 30° and 60°
  • the direction is toward the proximal end
  • the anchor 133 is between 0.5 and 4 mm in length
  • the head 134 is located at the center of the distal end surface of the anchor 130.
  • the anchoring area barb structure is mainly used to strengthen the structure of the entire left atrial appendage ablation device, and can also be used for ablation, and the electrode of the ablation member 120 achieves a double ablation function.
  • a further preferred embodiment is that the mesh skeleton 111 of the sealing member 110 is coated with an insulating coating at least on the sealing surface that is attached to the left atrial appendage, and the insulating coating is formed on the mesh skeleton 111 by coating with an insulating material.
  • One or more layers of insulating material, the insulating mesh skeleton 111 is in conductive contact with the left atrial appendage; the insulating of the sealing member 110 may also be applied to each of the wires or metal rods of the mesh skeleton 111 by using an insulating sleeve.
  • the sealing of the seal 110 is achieved by a baffle film 112 disposed inside thereof.
  • the periphery of the baffle film 112 is fixed to the inside of the mesh skeleton 111 by a stitching method, such as a PET or PTFE film.
  • a further preferred embodiment is that the anchoring body 131 of the anchoring member 130 is coated with an insulating coating on at least the sealing surface that is attached to the left atrial appendage, and the insulating coating is coated on the anchoring body 131 by means of an insulating material.
  • One or more layers of insulating material are formed, and the insulating anchoring body 131 is in contact with the left atrial appendage; the insulating of the anchoring member 130 may also be applied to each of the wires or metal rods of the anchoring body 131.
  • the outer surface of the occlusion device 100 except the electrode 122 of the ablation member 120 that is in contact with the inner wall surface of the auricle is insulated, thereby improving the ablation resistance of the entire left atrial appendage ablation device and reducing the entire left atrial appendage. Blocking the conductive contact surface area of the ablation device with blood and tissue, avoiding excessive energy loss at the blood or non-target tissue, thereby concentrating energy for tissue radiofrequency ablation at the target of the ablation zone, while reducing the ablation process Damage to tissue in non-ablation areas.
  • the electrode 122 of the ablation device 120 is an uninterrupted ring-shaped electrode, and the structure is adapted to the structure of the left atrial appendage, and is closely attached to the targeted ablation zone, and simultaneously achieves circumferential dense in-situ ablation of the left atrial appendage, which greatly improves The success rate of ablation shortens the operation time.
  • the connecting end 113 of the sealing member 110 can be connected to the conveying wire 2 by bolts, and the surface of the conveying wire 2 is insulated.
  • the insulating method is an insulating coating or an insulating sleeve with a polymer insulating material, and PTFE and FEP are preferred.
  • the ETFE or PFA cannula is received in a small diameter delivery sheath 3, then puncture through the femoral vein into the inferior vena cava, into the right atrium, and then through the interatrial septum into the left atrium 6.
  • the position of the left atrial appendage ablation device in the left atrial appendage 7 is positioned by contrast and ultrasound to ensure that the anchor 130 is released inside the left atrial appendage 7 after release, and the anchor puncture 133 is hooked into the left.
  • the inner wall of the auricle 7; the annular electrode 122 of the ablation member 120 is in close contact with the inner wall of the left atrial appendage 7 near the entrance, and the choke membrane in the sealing member 110 blocks the mouth of the left atrial appendage 7 to prevent blood flow from entering the left atrial appendage 7
  • the thrombus in the inner and left atrial appendages 7 flows into the left atrium 6 .
  • the tail end of the delivery wire 2 is connected to a radio frequency source---radio ablation generator, the radio frequency ablation parameter is adjusted, and the radiofrequency ablation energy is transmitted to the left atrial appendage through the delivery wire 2.
  • the connection end 113 of the ablation device 100 is blocked, and the connection end 113 receives the radio frequency ablation energy and transmits the ablation device 120 to the ablation device 120.
  • the ablation device 120 adopts a mesh weaving method, and the mesh is dense, so that the left side can be realized. The ablation of all targets in the circumferential direction of the inner wall of the opening of the auricle 7 is blocked.
  • the delivery lead 2 and the left atrial appendage ablation device 100 are released, and the left atrial appendage ablation device 100 remains in the left atrial appendage 7 to achieve long-term sealing performance.
  • the invention can realize the left atrial appendage plugging by using the structure of the left atrial appendage ablation device 100 in one operation, and realize the complete ablation of the left atrial appendage, thereby increasing the ablation success rate of the atrial fibrillation.
  • the electrode 122 of the ablation member 120 may be provided as a dot electrode.
  • the electrode 122 of the ablation member 120 may be provided as a rod electrode.
  • the electrode 122 of the ablation member 120 may be disposed as a ring-shaped annular electrode in a circumferential direction of the annular skeleton.
  • the electrode 122 of the ablation member 120 may be disposed as two or more annular electrodes, and the annular electrode may be continuous or intermittent. Or a combination of the two; the plurality of annular electrodes 122 may be arranged in parallel or staggered in the axial direction of the annular skeleton.
  • the left atrial appendage ablation device 100 of the present embodiment is also composed of three parts: a sealing member 110, an ablation member 120, and an anchor member 130.
  • the sealing member 110, the ablation member 120 and the anchoring member 130 are integrally formed.
  • the sealing member 110 is a sealing plug formed by the mesh skeleton 111 for sealing the left atrial appendage neck, and the sealing plug conforms to the shape of the left atrial appendage neck.
  • the anchoring body 131 is a cylindrical structure, and the distal end of the cylindrical structure is closed, and the proximal end is integrally connected with the ablation member 120.
  • the structure of the sealing member 110, the ablation member 120 and the anchoring member 130 of the present embodiment is the same as that of the embodiment 1.
  • the main difference is that at least the outer wall surface contacting the electrode 122 is provided outside the annular frame 121 to be the electrode.
  • the insulating film 101 is isolated from the ring skeleton 121. As shown in FIG. 8 , the insulating film 101 may be a spherical film, and the outer surface of the occlusion device 100 except the contact point of the annular frame 121 and the electrode 122 on the ablation member 120 is wholly or partially wrapped in insulation.
  • the spherical film means that the package is formed at least at the distal end face and the distal end portion.
  • the surface of the insulating film 101 of the present embodiment has a dense structure and is non-porous, and can achieve effective insulation.
  • the insulating film 101 can serve as an insulating barrier between the electrode 122 and the occlusion device, preventing the RF energy on the electrode 122 from being occluded to the occluder. The central direction is transmitted, so that the RF energy can be concentrated on the left atrial appendage wall, further preventing the loss of RF energy on the electrode 122 and improving the ablation efficiency.
  • the insulating film 101 is also disposed at the proximal end of the sealing member 110, the insulating film 101 is disposed as a barrier member to block the thrombus, and the blocking film in the sealing member 110 may or may not be disposed.
  • the insulating film 101 may be a toroidal film disposed between the annular frame 121 and the electrode 122 on the ablation member 120.
  • An insulating barrier between the electrode 122 and the occlusion device is formed.
  • the mesh skeleton 111 or/and the anchor body 131 may be coated with an insulating coating or interspersed with an insulating sleeve as in Embodiment 1.
  • the insulating film 101 may be fixed to the outer surface of the mesh structure 111, the annular frame 121 or the anchor body 131 by stitching, hot pressing, spraying, dipping, or the like, or the inner and outer surfaces of the mesh structure may be fixed at the same time.
  • the insulating film 101 may be made of an insulating material such as FEP, ETFE, PFA, PTFE, silica gel, or PEEK.
  • the position of the anchor 133 is relatively close to the proximal end of the anchor 130.
  • the electrode 122 in this embodiment may also be provided with a dot electrode, a rod electrode, a single or multiple turns of parallel or staggered, intermittent or continuous annular electrodes, or the above electrode 122, as shown in Embodiment 1. The combination.
  • the left atrial appendage ablation ablation device 100 of the third embodiment of the present invention is composed of three parts: a sealing member 110, an ablation member 120, and an anchor member 130.
  • the sealing member 110, the ablation member 120 and the anchoring member 130 are integrally formed.
  • the sealing member 110 is a sealing plug formed by the mesh skeleton 111 for sealing the left atrial appendage neck, and the sealing plug conforms to the shape of the left atrial appendage neck.
  • the anchoring body 131 is a cylindrical structure, the proximal end of the cylindrical structure is closed, the proximal end is integrally connected with the ablation member 120, and the distal end is open.
  • the basic structure is the same as in the first and second embodiments, and the insulation treatment method can be the same as in the first and second embodiments.
  • the anchor 133 and the anchor body 131 are integrally connected or fixedly connected, and the anchor 133 may be fixed to the anchor body 131 by the steel sleeve 135, or may be directly fixed to the anchor body 131.
  • the position and function of the connecting end 113 of the sealing member 110 are the same as those of the first embodiment, and the outer surface of the blocking device 100 except the contact point of the annular frame 121 and the electrode 122 on the ablation member 120 can be insulated.
  • the insulation treatment method and the form and arrangement of the electrodes 122 of the ablation member 120 can be the same as those of the embodiment 1 or 2.
  • the difference between the embodiment and the first embodiment and the second embodiment is that the distal end surface of the anchoring region of the left atrial appendage occluder ablation device 100 is an open structure, that is, the anchoring body 131 is cylindrical. Structure, the distal end of the anchor 130 is open without a head.
  • the electrode 122 in this embodiment may also be provided with a dot electrode or a rod electrode as shown in the embodiment 1.
  • the electrode is arranged in a single circle or in multiple rows in parallel or staggered, and may also be arranged as a ring electrode arranged intermittently or A continuous ring electrode can also be a combination of the above electrodes.
  • the left atrial appendage ablation device 100 of the fourth embodiment of the present invention is also composed of three parts: a sealing member 110, an ablation member 120, and an anchor member 130. Three-part integrated structure.
  • the seal, the ablation member 120 and the anchor member 130 are integrally formed.
  • the sealing member 110 is a sealing plug formed by the mesh skeleton 111 for sealing the left atrial appendage neck, and the sealing plug conforms to the shape of the left atrial appendage neck.
  • the anchor body is a frustum-like structure.
  • the sealing member 110, the ablation member 120 and the anchoring member 130 are all formed by laser cutting heat setting, wherein the sealing member 110 is located at the proximal end position, further comprising a grid skeleton 111 and a connecting end 113 formed by cutting; the position of the connecting end 113
  • the effect is the same as in the first embodiment.
  • the ablation member 120 is located in the middle region, and the ablation member 120 is provided with an electrode 122.
  • the electrode 122 is disposed in the same manner as the first embodiment;
  • the anchor member 130 is located at the distal end, and includes an anchor body 131 formed by cutting, and the anchor body 131 is externally disposed.
  • the anchor 133 is disposed on the wall surface, and the anchor 133 is integrated with the anchoring body 131.
  • the insulating treatment of the anchoring member 130 can be the same as that of the embodiment 1 or 2, and details are not described herein again.
  • the difference between the embodiment and the above embodiment 1-2 is that the distal end surface of the anchoring zone of the left atrial appendage occluder ablation device of the present embodiment has an open structure, that is, the anchoring body is a cylindrical structure.
  • the distal end of the anchor 130 is open without a head.
  • the outer surface of the left atrial appendage ablation device 100 can also be tapered or spherical. That is, the distal end of the anchor 130 is gradually inwardly contracted to form a distal opening having a diameter smaller than the diameter of the anchor 130.
  • the fifth left atrial appendage ablation device 100 of the present invention is composed of three parts: a sealing member 110, an ablation member 120 and an anchoring member 130.
  • the sealing member 110 and the ablation member 120 are connected by a connecting member 30, and the ablation member 120 and the anchoring member 130 are integrally formed. That is, the overall metal skeleton of the atrial appendage ablation device is a double disc structure, including a proximal disc and a telecentric disc.
  • the concentric disk and the telecentric disk are connected by a connecting member 30.
  • the proximal disc is heat-set by nickel-titanium wire braiding to form a sealing member 110; the telecentric disc includes an ablation member 120 and an anchoring member 130, and is also formed by nickel-titanium weaving.
  • the seal 110 is a sealing disk formed by the mesh skeleton 111 for sealing the left atrial appendage, and the sealing disk conforms to the shape of the left atrial appendage.
  • the sealing member 110 is pressed against the entrance of the left atrial appendage, the diameter of the sealing member 110 is slightly larger than the inner diameter of the left atrial appendage, and the sealing member 110 adopts a disc-shaped structure having a short axial length, and the disc-shaped structure can be directly pressed. Live in the entrance.
  • the main body of the sealing member 110 is a mesh skeleton 111.
  • One or more flow blocking films 112 are disposed in the mesh skeleton 111.
  • the end surface of the sealing member 110 is provided with a connecting end 113.
  • the blocking film 112 can be disposed in the sealing.
  • a polymer blocking film 112 is coated, and the blocking film 112 is preferably a PET or PTFE film.
  • the connecting end 113 is located at the center of the proximal disc surface of the proximal disc, such as a bolt head for connecting the conveying wire and receiving radio frequency ablation energy.
  • the ablation member 120 is located at the proximal end of the telecentric disk and is an annular mesh-shaped annular frame 121 having an axial length of 5 mm.
  • the surface of the annular frame 121 is fixed with an electrode 122.
  • an electrode 122 As shown in FIG.
  • a rod electrode, or a plurality of intermittent and/or uninterrupted ring electrodes provided in a plurality of turns may be provided.
  • part or all of the outer surface of the occlusion device 100 except the contact point of the annular skeleton 121 and the electrode 122 on the ablation member 120 is insulated. The insulation treatment can be combined with the embodiment.
  • the coating can be fixed on the grid skeleton 111 by coating, or can be an insulating sleeve, for example, an insulating sleeve made of FEP, ETFE, PFA, PTFE material.
  • an insulating sleeve made of FEP, ETFE, PFA, PTFE material.
  • the occlusion device 100 is completely wrapped by the spherical insulating film, that is, the outer surface of the sealing member 110 or the anchor member 130, or the inner and outer surfaces are simultaneously fixed with an insulating film, and the sealing member 110 is disposed.
  • the insulating film at the proximal end or/and the distal end, the insulating film disposed at the distal end of the anchor member 130 as a barrier member can function as a barrier to thrombus; or the insulating method combining the two methods of Embodiment 1 and Embodiment 2 .
  • the electrode 122 in this embodiment may also be provided with a dot electrode, a rod electrode, a single or multiple turns of parallel or staggered, intermittent or continuous annular electrodes, or the above electrodes, as shown in Embodiment 1. combination.
  • the anchor 130 is located at the distal end of the telecentric disk and includes an anchoring body 131, a baffle 132, an anchor 133 and a head 134.
  • the surface of the anchoring body 131 may not be insulated; the periphery of the blocking film 132 is fixed in the interior of the anchoring body 131 by sewing, such as a PET or PTFE film.
  • the anchor 133 is integrated or connected with the anchor body 131. In this embodiment, the anchor 133 is connected to the anchor body 131 by using a steel sleeve 135.
  • the anchor 133 is located at the distal end of the anchor 130, and the number is 6.
  • the anchor 133 is electrically conductive at least to the outer surface, and is electrically connected to the radio frequency source to ablate the anchor 133 and the left atrial appendage.
  • the anchor 133 is made of a conductive metal material, and the surface is not insulated.
  • the mesh skeleton 111 of the sealing member 110 and the annular skeleton 121 of the ablation member 120 are connected together by a connecting member 30, and may be joined together by welding or pressing.
  • the connecting member 30 has a columnar structure, and the connecting member 30 is disposed at the center of the end face of the proximal end of the ablation member 120 and the center of the end face of the distal end of the sealing member 110.
  • each part of the left atrial appendage ablation device of this embodiment is the same as that of the first embodiment.
  • the left atrial appendage ablation device 100 is released to the shape of the left atrial appendage 7 before the insulating steel cable is released, and the anchoring member 130 is anchored in the left atrial appendage 7, the ablation member 120 and the left
  • the mouth of the auricle 7 is closely attached; the seal 110 blocks the entrance of the left atrial appendage 7, preventing blood flow into the left atrial appendage 7 and the thrombus of the left atrial appendage 7 into the left atrium 6.
  • the tail end of the conveying wire 2 is connected to the radio frequency ablation generator device, the radio frequency ablation parameter is adjusted, the radio frequency ablation energy is transmitted to the sealing end 113 of the left atrial appendage ablation device 100 through the steel cable, and the end 113 receives the radio frequency ablation energy transfer.
  • the ablation member 120 is applied to the electrode 122 to effect an ablation procedure.
  • the left atrial appendage ablation device 100 is released to the shape of the left atrial appendage 7 before the insulated steel cable is released, and the anchor member 130 is anchored.
  • the ablation member 120 is closely attached to the mouth of the left atrial appendage 7; and the sealing member 110 is still in the sheath tube 3, at which time the left atrial appendage ablation device 100 is in a partially released state, the anchoring member
  • the upper baffle can serve as a partial plugging effect.
  • the tail end of the conveying wire 2 is connected to the radio frequency ablation generator device, the radio frequency ablation parameter is adjusted, the radio frequency ablation energy is transmitted to the sealing end 113 of the left atrial appendage ablation device 100 through the steel cable, and the end 113 receives the radio frequency ablation energy transfer.
  • the ablation member 120 is applied to the electrode 122 to effect an ablation procedure.
  • the radiofrequency ablation generating device is turned off, and the sealing member 110 is completely released.
  • the completely released sealing member 110 blocks the entrance of the left atrial appendage 7 to prevent blood flow from entering the left atrial appendage 7 and the left atrial appendage 7 Flow into the left atrium 6. This embodiment eliminates the need to insulate the seal.
  • the left atrial appendage ablation device 100 of the present embodiment 6 includes a sealing member 110, an ablation member 120 and an anchor member 130.
  • the sealing member 110 and the ablation member 120 are integrally formed, and the ablation member 120 is connected with the anchoring member 130 through the connecting member 30;
  • the sealing member 110 is formed by the mesh skeleton 111 for connecting the left atrial appendage with The sealing plug of the left atrial appendage and the neck simultaneously sealed, the sealing plug conforming to the shape of the left atrial appendage and the left atrial appendage.
  • the sealing member 110 is a sealing disc pressed at the entrance of the left atrial appendage, the sealing member 110 has a diameter slightly larger than the inner diameter of the left atrial appendage, and the sealing member 110 adopts a disc-shaped structure with a short axial length, and the disc-shaped structure can directly press Left atrial appendage entrance.
  • the atrial appendage ablation device is a double disc structure, including a proximal disc and a telecentric disc.
  • the concentric disk and the telecentric disk are connected by a connecting member 30.
  • the proximal disc includes a sealing member 110 and an ablation member 120; the telecentric disc is an anchoring member 130; the proximal disc and the telecentric disc are both formed by heat-setting a nickel-titanium wire braid.
  • the sealing member 110 is integrally formed with the ablation member 120 to form a cork shape.
  • the diameter of the sealing member 110 is larger than the diameter of the ablation member 120.
  • the diameter of the ablation member 120 is gradually reduced from the proximal end to the distal end to form a truncated cone shape.
  • the sealing member 110 is located at the proximal end of the concentric disk, the main body of the sealing member is a mesh skeleton 111, and one or more flow blocking films 112 are disposed in the mesh skeleton 111, and the end surface of the sealing member 110 is provided with a connecting end.
  • the blocking film 112 may be disposed in the sealing member 110, or a polymer blocking film 112 may be coated on the outer surface of the sealing member 110.
  • the blocking film 112 is preferably a PET or PTFE film.
  • the connection end 113 is located at the center of the proximal end surface of the proximal disc 10, such as a bolt head for connecting the delivery wire and receiving radio frequency ablation energy.
  • the ablation member 120 is located at the distal end of the proximal disc, and includes an annular skeleton 121.
  • the surface of the annular skeleton 121 is fixed with an electrode 122.
  • the fixing manner can be the same as that of Embodiment 1.
  • the electrode 122 is a single
  • the uninterrupted ring-shaped electrode provided in the circle may be provided with the same spot electrode as in the first embodiment, a rod electrode, or a plurality of intermittent and/or uninterrupted ring electrodes provided.
  • the electrode 122 is electrically connected to the radio frequency source through the annular frame 121 and the connection end 113.
  • the occlusion device 100 is partially or completely insulated from the outer surface of the ablation member 120 except the contact point of the annular skeleton 121 and the electrode 122.
  • the insulation treatment can be the same as that in the embodiment 1.
  • the coating can be fixed on the grid frame by coating, or can be an insulating sleeve, such as an insulating sleeve made of FEP, ETFE, PFA, PTFE material;
  • the outer surface of the occlusion device 100 except the contact point of the annular skeleton 121 and the electrode 122 on the ablation member 120 is partially or entirely wrapped with an insulating film, and the coating film is annular.
  • the insulating film disposed at the proximal end of the proximal disc or/and the distal end, and the insulating film disposed at the distal end of the anchor member 130 as a barrier member can serve as a barrier to thrombus.
  • the ablation member 120 can be provided with one or more layers of choke inside.
  • Membrane 123 Membrane 123
  • one or more layers of the blocking film 132 may be disposed on the outer surface of the anchor 130, and the blocking film 132 will be anchored.
  • the part or the whole of the piece is wrapped in the baffle film, and the baffle film 132 may be selected from a spherical or annular semi-permeable membrane or an impermeable membrane; by sewing or gluing to the outer surface of the anchor 130, The baffle 132 can further block the thrombus and increase the contact area of the anchor with the inner wall of the left atrial appendage to avoid damage to the wall of the left atrial appendage by excessive local force.
  • the electrode 122 in this embodiment may also be provided with a dot electrode, a rod electrode, a single or multiple turns of parallel or staggered, intermittent or continuous annular electrodes, or the above electrodes, as shown in Embodiment 1. combination.
  • the anchor 130 is located at the distal end of the telecentric disk and includes an anchoring body 131, one or more layers of the baffle 132, an anchor 133 and a head 134.
  • the anchor body is a cylindrical structure. Both the distal end and the proximal end of the cylindrical structure are closed to form a cylindrical structure.
  • the left atrial appendage ablation device 100 of the present embodiment 7 includes a sealing member 110, an ablation member 120 and an anchor member 130.
  • the sealing member 110 and the ablation member 120 are integrally formed, and the ablation member 120 is connected with the anchoring member 130 through the connecting member 30; the sealing member 110 is formed by the mesh skeleton 111 for connecting the left atrial appendage with The sealing plug of the left atrial appendage and the neck simultaneously sealed, the sealing plug conforming to the shape of the left atrial appendage and the left atrial appendage.
  • a sealing disk can also be used, which is integral with the ablation member 120.
  • the structure of the sealing member 110 and the ablation member 120 is the same as that of Embodiment 6, and details are not described herein again.
  • the electrode 122 in this embodiment may also be provided with a dot electrode, a rod electrode, a single or multiple turns of parallel or staggered, intermittent or continuous annular electrodes, or the above electrodes, as shown in Embodiment 1. combination.
  • the anchoring body is a folded structure, and the folding structure is extended from the center of the distal end of the ablation member 120 toward the outer side in the telecentric direction, and is formed by gradually folding back. Uniformly set on the outer wall of the folded structure.
  • the specific structure is that the anchoring member 130 is a braided or laser-cut distal opening structure, and extends from the connecting member 30 at the distal end of the ablation member 120 to the telecentric direction to form an internal supporting segment, and then reversely folds to form an anchoring portion.
  • the folded structure gathers toward the center after folding to form a closed structure.
  • the folded structure does not converge toward the center after folding, forming an anchoring body with a proximal opening.
  • the proximal opening faces the ablation member 120, and the proximal end of the anchor member 130 is spaced from the ablation member 120.
  • the proximal opening can be divided into a semi-opening that contracts toward the center and a full-opening structure that does not contract toward the center.
  • the anchoring body may be selected from the mesh structure as shown in FIG. 18, or as shown in FIG. 20 to FIG.
  • the anchoring body 131 of the anchoring member 130 is a frame structure formed by a plurality of supporting rods, and supports
  • the rod may be a simple linear structure in which each root is independent of each other, or a complex structure formed by cross-linking each other.
  • one or more blocking films 132 may be disposed on the outer surface of the anchor 130, and the blocking film 132 may be disposed.
  • a portion or the entirety of the anchor is wrapped within a baffle 132, which may be selected from a spherical or annular semi-permeable membrane or an impermeable membrane; by suturing or gluing to the anchor 130
  • the outer surface, the baffle 132 can further block the thrombus and increase the contact area of the anchor with the inner wall of the left atrial appendage to avoid damage to the wall of the left atrial appendage by excessive local force.
  • the left atrial appendage ablation device 100 of the present embodiment includes a seal member 110, an ablation member 120, and an anchor member 130.
  • the skeleton structure of the left atrial appendage ablation device of the present embodiment has a three-disk structure, including a proximal disc, an intermediate disc, a telecentric disc and a connecting member 30 therebetween. That is, between the sealing member 110 and the ablation member 120, and between the ablation member 120 and the anchor member 130, respectively, through the connecting member 30.
  • the near-center disk is a sealing member 110, which is formed by heat-setting a nickel-titanium wire braid, and comprises a mesh frame 111, one or more layers of the choke film 112 and the connecting end 113; the arrangement of the choke film and the connecting end and the embodiment 1 the same.
  • the intermediate plate is an ablation member 120, which is formed by heat-setting a nickel-titanium wire, and includes an annular frame 121.
  • the surface of the annular frame 121 is fixed with an electrode 122.
  • the electrode 122 is disposed in a single turn.
  • the uninterrupted ring-shaped electrode the same spot electrode as in the first embodiment, a rod electrode, or a plurality of intermittent and/or uninterrupted ring electrodes may be provided.
  • the occlusion device 100 is partially or completely insulated from the outer surface of the ablation member 120 except the contact point of the annular skeleton 121 and the electrode 122.
  • the insulation treatment can be the same as that in the embodiment 1.
  • the coating can be fixed on the grid frame by means of insulating material coating, or it can be insulating sleeve, for example, insulating sleeve made of FEP, ETFE, PFA, PTFE material.
  • the outer surface of the occlusion device 100 except the contact point of the annular skeleton 121 and the electrode 122 on the ablation member 120 is partially or entirely wrapped with an insulating film, and the insulating film is Example 2 is the same.
  • the electrode 122 in this embodiment may also be provided with a dot electrode, a rod electrode, a single or multiple turns of parallel or staggered, intermittent or continuous annular electrodes, or the above electrodes, as shown in Embodiment 1. combination.
  • the telecentric disk is an anchoring member 130, which is woven by nickel-titanium wire or laser-cut by a tubular body, and comprises an anchoring body 130, one or more layers of the baffle film 132, an anchoring structure 133 and a head 134.
  • the anchor body 130 and the head 134 and the flow blocking film 132 are disposed in the same manner as in the seventh embodiment.
  • the anchor 133 is connected in the same manner as in the first embodiment, and is fixed to the wire by a steel sleeve 135.
  • one or more layers of the flow blocking film 132 may be disposed on the outer surface of the anchor 130, and the blocking film 132 may partially or entirely enclose the anchor.
  • the baffle film 132 may be selected from a spherical or annular semi-permeable membrane or an impermeable membrane; the gas barrier membrane 132 may be sewn or glued to the outer surface of the anchor 130. The thrombus is further blocked, and the contact area between the anchor and the inner wall of the left atrial appendage is increased to avoid damage to the wall of the left atrial appendage by excessive local force.
  • the left atrial appendage ablation device is constructed of three parts: a seal 110, an ablation member 120, and an anchor member 130.
  • the sealing member 110 is located in the proximal end region, and further includes a mesh structure 111, one or more layers of the flow blocking film 112 and the connecting end 113; the blocking film 112 is fixed in the mesh wire skeleton 111 by stitching.
  • the baffle film 112 may be selected from a PET or PTFE film; the proximal end of the seal 110 is provided with a connection end that is detachably coupled to the conveyor.
  • the connecting end 113 is located at the center of the end face of the proximal end, and the bolt head is preferred.
  • the sealing member 110, the ablation member 120 and the anchoring member 130 are integrally formed, that is, the mesh structure 111 of the sealing member 110, the annular skeleton 121 of the ablation member 120, and
  • the anchoring body 131 of the anchoring member 130 is a unitary structure, and the sealing member 110, the ablation member 120 and the anchoring member 130 have the same diameter, and the integral device exhibits a round plug structure.
  • the wire is woven into a sealing member 110, and the ablation member 120 and the anchoring member 130 are integrally formed into three parts, and then formed.
  • the connecting end 113 disposed on the sealing member 110 is bundled with the metal frame at the proximal end surface.
  • the head end; the head 134 converges the distal end of the metal frame head end of the anchor member 130, as shown in FIG.
  • the braided wire of this embodiment may be a nickel titanium alloy, a cobalt chromium alloy, a stainless steel or other metal material having good biocompatibility.
  • the superelastic shape memory alloy nickel-titanium wire is preferred, and the manufacturing process thereof is the same as that of the conventional left atrial appendage occluder, and will not be described herein.
  • the integral structure of the sealing member 110, the ablation member 120 and the anchoring member 130 may also be a structure directly fixed together by welding or the like.
  • the sealing member 110 is a sealing plug formed by the mesh structure 111 for sealing the left atrial appendage neck.
  • the sealing plug conforms to the shape of the left atrial appendage neck; in this embodiment, the sealing member 110 is inserted into the left atrial appendage.
  • the diameter of the sealing member 110 coincides with the inner diameter of the left atrial appendage, and the sealing member 110 has a cylindrical structure, and the outer wall surface of the cylindrical structure is a sealing surface.
  • the sealing member 110 encloses the left atrial appendage through a baffle 112 disposed therein.
  • the periphery of the baffle film 112 is fixed inside the mesh structure 111 by a plurality of stitching points by a stitching method, and the choke film 112 may be a PET or PTFE film.
  • the ablation member 120 is located at an intermediate portion of the three, and the ablation member 120 includes an annular skeleton 121 that is attached to the inner wall of the left atrial appendage for a week.
  • the annular skeleton 121 is the main body of the ablation member 120.
  • the structure is formed by weaving a wire into a grid pattern that intersects each other.
  • the connecting electrode 122 is fixed on the annular frame 121.
  • the electrode 122 can be fixed on the annular frame 121 by stitching or winding.
  • the electrode 122 fixed to the annular frame 121 is directly connected to the RF source, that is, the electrode 122 directly passes through the wire and The wire on the conveyor is connected to the RF source, and the RF energy does not need to pass through the metal frame of the occlusion device.
  • the annular electrode 122 has no space between each other, and can be connected to the RF source through at least one wire, the wire and the electrode.
  • 122 is fixedly connected by welding or steel sleeve.
  • a further preferred embodiment is to insulate at least the position where the electrode 122 is in contact with the annular skeleton 121 of the ablation member 120, at which time the radio frequency energy can be concentrated on the electrode 122 for ablation to achieve a better ablation effect.
  • the insulating treatment is performed by coating an outer surface of the metal ring skeleton 121 in contact with the electrode 122 with an insulating coating, or inserting an insulating sleeve over the annular frame 121, and the insulating sleeve is wrapped around the annular skeleton.
  • the outer surface of the 121, coating or sleeve material may be selected from the group consisting of FEP/ETFE/PFA.
  • the electrode 122 selects a single-turn electrode, and the single-turn electrode may select a ring structure formed by continuously arranging a plurality of single electrodes in the circumferential direction of the annular skeleton, or may be a ring that is independently looped around the annular skeleton. Electrode, this embodiment selects a ring electrode.
  • the electrode 122 has an axial length of between 1 and 12 mm, preferably 5 mm in this embodiment. As shown in FIG. 1, one or more layers of the flow blocking film 123 may also be disposed in the ablation member 120.
  • the anchor 130 is located at the distal end of the device, and includes an anchoring body 131, a blocking film 132, an anchor 133 and a head 134; the anchoring body 131 is a cylindrical structure.
  • the cylindrical structure that is, the diameter of the anchor 130 is substantially the same as the inner diameter of the left atrial appendage, and the contact between the outer wall surface of the anchor 130 and the inner wall of the left atrial appendage forms a frictional force, and the anchor 130 can be directly used for anchoring.
  • the anchor body 131 of the anchor 130 is provided with a plurality of anchors 133 for anchoring on the inner wall of the left atrial appendage, and the anchors 133 are evenly arranged on the outer wall of the tubular structure, after the device is implanted, The anchor thorn penetrates into the inner wall of the left atrial appendage and anchors it with anchor thorn anchoring stability.
  • the distal end of the anchoring body 131 of the tubular structure is closed, and the proximal end is integrally connected with the ablation member 120.
  • At least one flow blocking film 132 is disposed in the anchor body 131, and the periphery of the flow blocking film 132 is fixed to the inside of the anchor body 131 by sewing, such as a PET or PTFE film.
  • the anchor 133 and the anchor body 131 are a unitary structure or a fixed connection structure.
  • the anchor 133 is connected to the anchor body 131 by using a steel sleeve 135, and the position is at the distal end of the anchor 130, and the number is 6-
  • the anchor 133 opening angle is between 30° and 60°
  • the direction is toward the proximal end
  • the anchor 133 is between 0.5 and 4 mm in length
  • the head 134 is located at the center of the distal end surface of the anchor 130.
  • Anchoring area barb structure mainly used to strengthen the structure of the entire left atrial appendage ablation device
  • the occlusion device 100 adopts an insulating coating on the surface of the ablation ring skeleton 121 contacting the ablation electrode 122 or inserts an insulating sleeve on the wire of the ablation member of the annular skeleton 121, thereby improving the ablation impedance of the entire left atrial appendage ablation device. Decreasing the left atrial appendage to block the conductive contact surface area of the ablation device with blood and tissue, avoiding excessive energy loss at the blood or non-target tissue, thereby concentrating energy for tissue radiofrequency ablation at the target of the ablation zone, It can reduce the damage of the ablation process to the tissue in the non-ablation zone.
  • the ablation member electrode 122 is an uninterrupted ring-shaped electrode.
  • the structure is adapted to the left atrial appendage structure, and is closely attached to the targeted ablation zone, and simultaneously achieves a circumferentially dense annular ablation of the left atrial appendage, which greatly improves the ablation success. Rate, shorten the operation time.
  • the connecting end 113 of the sealing member 110 can be connected to the delivery catheter 2 by bolts, and can be collected into a small diameter delivery sheath tube 3, and then puncture through the femoral vein into the inferior vena cava 10 to enter the right atrium 9, and then The left atrium is accessed through atrial septum.
  • the position of the left atrial appendage ablation device in the left atrial appendage 7 is positioned by contrast and ultrasound to ensure that the anchor 130 is released inside the left atrial appendage 7 after release, and the anchor puncture 133 is hooked into the left.
  • the inner wall of the auricle 7; the ablation member 120 is in close contact with the inner wall of the left atrial appendage 7 near the entrance, and the choke membrane in the sealing member 110 blocks the mouth of the left atrial appendage 7 to prevent blood flow into the left atrial appendage 7 and the left atrial appendage 7
  • the internal thrombus flows into the left atrium 6 .
  • the tail end of the delivery wire 4 connected to the electrode 122 is connected to a radio frequency source---radio ablation generator, the radio frequency ablation parameter is adjusted, and the radiofrequency ablation is performed through the delivery wire 4.
  • the energy is transmitted to the left atrial appendage to block the electrode 122 of the ablation device 100.
  • the electrode 122 receives the radiofrequency ablation energy to achieve the ablation procedure.
  • the delivery wire 4 and the electrode 122 can be released.
  • the outer surface of the conveying wire 4 and the conveying pipe 2 is insulated, and the surface of the conveying pipe 2 and/or the conveying wire 4 is insulated.
  • the insulating method is an insulating coating or an insulating sleeve with a polymer insulating material, and PTFE is preferred.
  • PTFE is preferred.
  • FEP, ETFE, PFA or PEEK polyetheretherketone
  • the ablation member electrode 122 of the present embodiment uses an uninterrupted ring electrode, so that the ablation of all targets in the circumferential direction of the left atrial appendage can be achieved.
  • the delivery catheter 2 and the left atrial appendage ablation device 100 are released, and the left atrial appendage ablation device 100 remains in the left atrial appendage 7 to achieve long-term sealing performance.
  • the invention can utilize the structure of the left atrial appendage ablation device 100 in one operation to realize the left atrial appendage sealing and the high-efficiency complete ablation of the left atrial appendage, thereby restoring the sinus rhythm.
  • the electrode 122 of the ablation member 120 may be provided as a dot electrode.
  • the electrode 122 of the ablation member 120 may be provided as a rod electrode.
  • the electrode 122 of the ablation member 120 may be provided as a single-turn intermittent annular electrode in the circumferential direction of the annular skeleton.
  • the electrode 122 of the ablation member 120 may be disposed as two or more annular electrodes, and the annular electrode may be continuous or intermittent. Or a combination of the two; the plurality of annular electrodes 122 may be arranged in parallel or staggered in the axial direction of the annular skeleton.
  • the dispersed dot electrodes, the rod electrodes or the intermittent ring electrodes can be connected in series through a wire and then connected to the RF power source through the wire, or can be connected to the RF power source through a plurality of wires.

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Abstract

一种左心耳封堵消融装置（100），包括位于近端的用于封闭左心耳（7）的密封件（110）、位于远端的用于将装置（100）锚定在左心耳（7）中的锚定件（130）；装置（100）还包括用于对左心耳（7）内壁进行环状消融的消融件（120）；消融件（120）包括用于与左心耳（7）需消融的内壁贴合的电极（122）和环状骨架（121），电极（122）与射频源电连接。左心耳封堵消融装置（100）能够同时实现对左心耳（7）的封堵和消融、操作简单、使用方便、对手术方式和手术时间不产生较大影响。

Description

左心耳封堵消融装置 技术领域
本发明属于医疗器械技术领域，具体涉及一种左心耳封堵消融装置，该装置利用经皮穿刺的方式通过输送导管将其输送到心脏左心耳的位置，能够同时实现对左心耳的封堵和消融。
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。
经导管射频消融是当今房颤的治疗热点之一。针对药物难以控制的房颤，射频消融可以改良房室结或彻底消融房室结置入起搏器以控制心室率；心房内线性消融或消融肺静脉(包括点消融、节段性消融及环状消融)以预防房颤复发。
虽然射频消融术仍是目前针对房颤的主要术式，但是通过该手术恢复窦性心律，主要目的是改善心悸、胸闷等患者症状，改善心脏功能，部分患者由于血栓栓塞问题，即使射频消融手术成功也需要终身抗凝来解决血栓栓塞的问题，病患需要在消融术后服用口服抗凝药物，这样就增加了患者的经济负担，同时也降低了患者的生活质量。
为了预防心房颤动血栓栓塞，可以使用左心耳封堵器对左心耳进行封堵，这是近年来发展起来的一种创伤较小的操作简单、耗时较少的治疗方法。现今的左心耳封堵装置主要是在自膨胀镍钛记忆合金笼状结构支架的外面包被可扩张的高分子聚合物膜，将封堵器置入左心耳进行封堵。高分子聚合物膜可以封闭左心耳的心房入口，隔绝左心耳和左房体部，防止血流相通。封堵器置入后，左心房内皮细胞会在高分子聚合物膜表面爬行生长，一段时间后形成新的内皮。但是单纯左心耳封堵器置入仅能起到卒中预防的作用，却不能改善房颤 症状。
从房颤治疗的整体高度上来讲，恢复窦律和卒中预防是两个并行的治疗策略，其重要性不分伯仲。目前，采用联合导管射频消融和左心耳封堵的治疗方法，已经取得了很多成功治疗房颤的案例。联合治疗方法中，通过左心耳封堵术，相对于单一的口服抗凝药物或房颤消融，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”。采用这种消融方法，患者1年后的房颤复发率较高。并且采用这种常规的射频消融导管进行治疗，操作难度较大，用时也较长，且会出现不能完全隔离的情况，难以维持远期疗效。
发明内容
本发明要解决的技术问题在于，针对现有技术射频消融和封堵各自独立进行，其中射频消融操作难度较大、用时较长，且会出现不能完全隔离的情况、难以维持远期疗效的缺陷，提供一种配合实现房颤消融和卒中预防的改进的左心耳封堵装置。
本发明解决其技术问题所采用的技术方案是：
一种左心耳封堵消融装置，包括位于近端的用于封闭左心耳的密封件、位于远端的用于将装置锚定在左心耳中的锚定件；还包括用于对左心耳内壁进行环状消融的消融件；所述消融件包括用于与左心耳需消融的内壁贴合的电极和环状骨架，所述电极与射频源电连接。
所述左心耳封堵消融装置中，所述消融件的环状骨架的环形外壁面至少设置一圈电极，所述电极通过环状骨架与射频源电连接。
所述左心耳封堵消融装置中，所述密封件上设有连接端，所述连接端分别与消融件的电极和射频源电连接。
所述左心耳封堵消融装置中，所述连接端设置在密封件近端端面中心，所述连接端通过密封件的网格骨架与消融件的电极电连接；
或者所述密封件中心设有过渡连接件，用于连接端与消融件的电极电连接。
所述左心耳封堵消融装置中，所述环状骨架在与电极接触的部分不绝缘，其余部分至少在锚定件外表面绝缘。
或者所述左心耳封堵消融装置中，所述电极直接与射频源电连接；所述消融件上至少与电极接触的部分绝缘。
所述左心耳封堵消融装置中，所述密封件设有与所述左心耳内壁贴合的密封面。
所述左心耳封堵消融装置中，所述密封件、消融件与锚定件三者一体结构；
或者所述密封件与消融件二者一体结构，所述消融件与锚定件通过连接件连接；
或者所述密封件与消融件通过连接件连接，所述消融件与锚定件二者一体结构；
或者所述密封件与消融件之间、所述消融件与锚定件之间分别通过连接件连接。
所述左心耳封堵消融装置中，所述密封件为金属网格骨架形成的密封盘；
或者所述密封件为所述金属网格骨架形成的密封塞；
或者所述密封件为所述金属网格骨架形成的密封塞盘，所述密封塞盘包括背向所述消融件的盘面、朝向所述消融件的盘底以及连接所述盘面和所述盘底的腰部。
所述左心耳封堵消融装置中，所述网格骨架至少在与左心耳贴合的密封面涂覆有绝缘涂层；
或者所述网格骨架外至少在密封面处设有绝缘膜；
或者所述网格骨架由金属丝或金属杆制成，至少在密封面处的所述金属丝或金属杆穿套有绝缘套管。
所述左心耳封堵消融装置中，所述环状骨架的环形外壁面连续设置或间断设置有单圈电极或多圈电极，多圈电极中各圈电极之间在环状骨架轴向上平行排列或者交错排列。
所述左心耳封堵消融装置中，所述电极为独立围绕环状骨架成环的环电极；
或者所述电极由多个单电极在环状骨架周向上连续排布或间隔排布形成的环状结构。
所述左心耳封堵消融装置中，所述电极与环状骨架之间通过缝合、焊接、缠绕或者钢套的方式连接。
所述左心耳封堵消融装置中，所述环状骨架为编织或切割制成的网状结构、杆状结构或框架结构中的至少一种。
所述左心耳封堵消融装置中，所述锚定件包括锚定主体，所述锚定主体侧面一周间隔设置多个锚刺，所述锚刺朝向近心端外侧方向延伸。
所述左心耳封堵消融装置中，所述锚刺至少外表面导电，且与射频源电连接。
所述左心耳封堵消融装置中，所述锚定主体为圆筒状结构，所述锚定主体的远端和近端中至少一端封闭；或者圆筒状结构的锚定件的远端和近端都开口。
所述左心耳封堵消融装置中，所述锚定主体为翻折结构，所述翻折结构为由消融件远心端的中心向远端方向外侧延伸，并逐步反向翻折形成，所述锚刺在翻折结构外壁一圈均匀设置。
所述左心耳封堵消融装置中，所述翻折结构在翻折后向中心汇聚，形成近端封闭或近似封闭的锚定主体；
或者所述翻折结构在翻折后不向中心汇聚，形成近端开口的锚定主体。
所述左心耳封堵消融装置中，所述锚定主体的金属网格骨架至少在与所述左心耳贴合的外壁面涂覆有绝缘涂层；
或者所述金属网格骨架外至少在所述外壁面处设有绝缘膜；
或者所述金属网格骨架由金属丝或金属杆制成，所述金属网格骨架中至少在与所述左心耳内壁面贴合或靠近所述左心耳内壁面的所述金属丝或所述金属杆上穿套有绝缘套管。
所述左心耳封堵消融装置中，在密封件、消融件和锚定件中，至少在其中一个的径向上设有封闭左心耳的阻隔件。
所述左心耳封堵消融装置中，所述阻隔件为至少在密封件内部径向设有的至少一个阻流膜，所述阻流膜横向设置并固定内壁上；
或者所述阻隔件为至少在密封件近端或/和远端设置的横向封闭的绝缘膜；
或者所述阻隔件为至少在锚定件远端或/和近端设置的横向封闭的绝缘膜。
本发明的左心耳封堵消融装置具有以下有益效果：
左心耳封堵消融装置的近端设置密封件，用于封堵左心耳与左心房之间通 道，避免左心耳内血栓进入左心房；远端设置锚定件，可将整个左心耳封堵消融装置稳固固定在左心耳中；同时在密封件和锚定件之间靠近左心耳入口处或者左心耳入口处设置消融件，所述消融件的电极对靠近左心耳入口的内壁位置进行消融，增加房颤消融的治愈成功率；并且由于通过电极进行消融，电极与射频电源电连接，能够大大提高消融的效率。这三部分配合实现房颤消融和卒中预防。在手术中，植入操作简单可靠、使用方便、对现有的手术方式和手术时间不产生较大影响。
附图说明
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1为实施例1左心耳封堵消融装置的结构示意图；
图2为实施例1俯视图；
图3为实施例1左心耳封堵消融装置释放到左心耳示意图；
图4为实施例1左心耳封堵消融装置另一种实施方式的结构示意图；
图5为实施例1左心耳封堵消融装置另一种实施方式的结构示意图；
图6为实施例1左心耳封堵消融装置另一种实施方式的结构示意图；
图7为实施例1左心耳封堵消融装置另一种实施方式的结构示意图；
图8为实施例2左心耳封堵消融装置的结构示意图；
图9为实施例2左心耳封堵消融装置另一种实施方式的结构示意图；
图10为实施例3左心耳封堵消融装置的结构示意图；
图11为实施例3左心耳封堵消融装置锚定件远心端的结构示意图；
图12为实施例4左心耳封堵消融装置的结构示意图；
图13为实施例5左心耳封堵消融装置的结构示意图；
图14为实施例5左心耳封堵消融装置锚定件远心端的结构示意图；
图15A至图15B为实施例5左心耳封堵消融装置释放到左心耳示意图；
图16为实施例6左心耳封堵消融装置的结构示意图；
图17为实施例6左心耳封堵消融装置另一种实施方式的结构示意图；
图18为实施例7左心耳封堵消融装置的结构示意图；
图19为实施例7左心耳封堵消融装置另一种实施方式的结构示意图；
图20为实施例7左心耳封堵消融装置另一种实施方式的结构示意图；
图21为实施例7左心耳封堵消融装置另一种实施方式的锚定件结构示意图；
图22为实施例7左心耳封堵消融装置另一种实施方式的结构示意图；
图23为实施例8左心耳封堵消融装置的结构示意图；
图24为实施例9左心耳封堵消融装置的结构示意图；
图25为实施例9俯视图；
图26为实施例9左心耳封堵消融装置释放到左心耳示意图；
图27为实施例9左心耳封堵消融装置另一种实施方式的结构示意图；
图28为实施例9左心耳封堵消融装置另一种实施方式的结构示意图；
图29为实施例9左心耳封堵消融装置另一种实施方式的结构示意图；
图30为实施例9左心耳封堵消融装置另一种实施方式的结构示意图。
具体实施方式
为了对本发明的技术特征、目的和效果有更加清楚的理解，现对照附图详细说明本发明的具体实施方式。
方位定义：本发明中的远端和近端是相对于操作者而言，封堵装置中距离操作者更近的一端为近端，远离操作者的一端为远端。该装置的轴向指该装置中轴线所在方向，径向为与中轴线垂直的方向，周向为绕圆柱体轴线方向(同时垂直于轴向和径向)。
应当说明的是，本申请中的左心耳除了包括左心耳内部外，还包括连接左心耳与左心房的部分。
如图1所示，一种左心耳封堵消融装置，包括位于近端的用于封闭左心耳的密封件110，位于远端的用于将装置锚定在左心耳中的锚定件130；还包括用于对左心耳内壁进行环状消融的消融件120，其中所述消融件120设有用于与左心耳需消融内壁贴合的电极122和环状骨架121，所述电极122与射频源电连接，整个装置中，所述环状骨架121在与电极122接触的部分不绝缘，其余部分至少在锚定件130外表面绝缘。此处，其余部分包括密封件110、消融件120中与电极不接触的部分、锚定件130。
密封件110的作用是阻塞分隔左房体和左心耳，避免左心耳内血栓进入左心房，所述密封件110设有与左心耳入口或/和左心耳内壁贴合且绝缘的密封面。锚定件130可将整个左心耳封堵消融装置稳固固定在左心耳中；所述消融件120设置在所述密封件与锚定件之间并在植入后靠近左心耳入口处或者左心耳入口处；通过其上设置的电极122对左心耳入口处或者附近的内壁进行消融，增加房颤消融的治愈成功率。
对于所述密封件110、消融件120与锚定件130三者的连接关系，可以有以下几种实施方式：
第一种实施方式：所述密封件110、消融件120与锚定件130三者一体结构；一体结构可以是通过焊接等方式直接固定在一起的结构，也可以是一体成型制成的整体结构。
第二种实施方式：所述密封件110与消融件120二者一体结构，所述消融件120与锚定件130通过连接件30连接；同样，一体结构可以是通过焊接等方式直接固定在一起的结构，也可以是一体成型制成的整体结构。连接件30的作用是将消融件120与锚定件130连接在一起，因此对连接件30的结构不作限定，可以是根据消融件120和锚定件130结构不同，采用任意形状，例如在消融件120与锚定件130之间采用多个轴向设置的连接杆、或在轴向中心设置的连接柱、或金属网等。
第三种实施方式：所述密封件110与消融件120通过连接件30连接，所述消融件120与锚定件130二者一体结构；本实施方式中的连接结构同第二实施方式，在此不再赘述。
第四种实施方式：所述密封件110与消融件120之间、消融件120与锚定件130之间分别通过连接件30连接。连接件30的结构同上，在此不再赘述。
本发明的装置要置入左心耳，则装置的形状与左心耳形状配合，为轴对称结构，且其径向各处的剖面为圆形或近似圆形。由于三部分连接方式不同，使得三者的形状也不同，即在左心耳中消融位置确定时，其他部件以消融件120的位置为准，进行设定，如果在消融件120与密封件110之间设置连接件30，加长二者之间的距离，则密封件110的密封位置在左心耳入口，密封件110的直径大于消融件120直径，而消融件120与密封件110一体结构，密封件110 的密封位置在左心耳中，密封件110直径与消融件120直径相同或者略大于消融件120直径。同样，由于锚定件130用于在左心耳中锚定，则锚定件130的锚定主体形状满足：设置在锚定主体131上的锚刺能刺入到左心耳中锚定。
密封件110的主体为网格骨架111，网格骨架111可以采用金属丝编织而成，也可以采用金属管切割后形成网格状框架结构。密封件110的形状可以是圆盘状、圆筒状、圆盘状与圆筒状的结合形成的阶梯形。网格骨架111中网孔的大小、形状根据实际需要设定，本发明不作限定。
对于密封件110对左心耳的密封，根据密封位置有以下几种实施方式：
密封件110的第一种实施方式：所述密封件110为网格骨架111形成的用于将左心耳入口处密封的密封盘，所述密封盘与左心耳入口处形状配合一致；该实施方式中，密封件110是压住左心耳入口处，密封件110直径稍大于左心耳的内径，并且密封件110采用轴向长度较短的圆盘状结构，圆盘状结构能直接压住入口。
密封件110的第二种实施方式：所述密封件110为网格骨架111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致；该实施方式中，密封件110是塞入左心耳的左心耳颈部中，密封件110直径与左心耳的内径一致，并且密封件110采用圆筒状结构。
密封件110的第三种实施方式：所述密封件110为网格骨架111形成的用于将左心耳入口处与左心耳颈部同时密封的密封塞盘，所述密封塞盘与左心耳入口处和左心耳颈部形状配合一致。该实施方式中，密封件110的近心端是圆盘状、远心端为圆柱状或直径逐渐变小的圆台状，圆盘状部分直径大于圆柱状或圆台状部分直径。其中压住左心耳入口处的密封件110圆盘状部分的直径稍大于左心耳的内径，塞入左心耳的密封件110圆柱状或圆台状部分直径与左心耳内径一致。
密封件110主体结构为网格骨架111，因此，为了更好密封，优选密封件110设置有阻隔件，设置在密封件110上的阻隔件可以有两种不同的方式：一种是设置在密封件110内部，一种是设置在密封件110近心端或/和远心端。设置在内部就可以采用阻流膜，设置在近心端或/和远心端可以采用阻流膜或/和绝缘膜。
密封件110的主要作用是密封，由于消融件120早于密封件110释放，因此，可以在释放消融件120后先进行消融，完成后，切断电源再释放密封件110，因此，密封件110可以不绝缘。
消融前释放密封件110时，优选进行绝缘处理，根据绝缘方式不同可以采用以下不同实施方式：
密封件110绝缘的第一种实施方式：密封件110的网格骨架111至少在与左心耳贴合的密封面涂覆有绝缘涂层；密封面指密封件110中与心耳贴合的壁面。至少在密封面涂覆有绝缘涂层，是指至少在密封件110外周壁面涂覆绝缘涂层，绝缘涂层是采用绝缘材料涂覆的方式在网格骨架111上形成一层或多层的绝缘材料，隔绝网格骨架111与左心耳接触导电。
密封件110绝缘的第二种实施方式：所述网格骨架111外至少在密封面处设有绝缘膜；绝缘膜可采用缝合、热压、喷涂、浸沾等方式固定在网格骨架111外表面形成密封面，或者网格骨架111内外表面同时固定绝缘膜，绝缘膜可以是FEP、ETFE、PFA、PTFE、硅胶材料制成。
密封件110绝缘的第三种实施方式：所述网格骨架111由金属丝或金属杆制成，至少在密封面处的所述金属丝或金属杆穿套有绝缘套管。绝缘套管采用FEP、ETFE、PFA、PTFE等材料制成的管状。穿装在金属丝或金属杆外，将网格骨架1110与左心耳内壁隔开绝缘。
所述密封件110的绝缘方式也可以采取以上两种方式的组合，例如第一种绝缘涂层结合第二种固定绝缘膜；或者第三种穿套绝缘套管结合第二种固定绝缘膜。
所述密封件110的近端设有与输送器可拆卸连接的连接端113。优选连接端113设置在密封件110的近端端面中心。连接端113通过输送器内的输送导线与射频源电连接，并通过封堵装置的导电的骨架将射频能量传递至消融件120的电极122上。
由于消融件120对左心耳内壁进行环状消融，所述消融件120包括与左心耳内壁贴合一周的环状骨架121和电极122，所述环状骨架121为编织或切割制成的金属丝网、金属杆、金属网架中的至少一种，即环状骨架121为环状，可以为金属丝编织形成相互交叉的网格状、也可以是金属杆相互平行设置形成 的栅栏状，还可以是螺旋状等多种能径向收缩和伸张的结构。
消融件120上的电极122在环状骨架121上的设置方式有两种：第一种实施方式是所述环状骨架121的环形外壁面一圈连续设置电极122，电极122排布方式为单圈电极或多圈电极。单圈电极是沿环状骨架的环形外壁面一圈设置一圈电极122。多圈电极是沿环状骨架的环形外壁面一圈设置至少两圈电极122，相邻两圈电极122之间在环状骨架轴向上并列排布或间隔排布。连续设置电极122也分为两种实施方式，一种是所述电极122由多个单电极在环状骨架周向上连续排布形成的环状结构。另一种是所述电极122为独立围绕环状骨架成环的环电极。
第二种实施方式是：所述环状骨架的环形外壁面一圈间断设置有单圈电极或多圈电极，单圈电极或多圈电极中的所述电极122由多个单电极在环状骨架周向上间隔排布形成的环状结构。多圈电极中各圈电极122之间在环状骨架轴向上平行排列或者交错排列。
所述电极122中，单电极的形状可选自点状、杆状、片状等，环电极为间断或不间断的环状结构，电极122轴向长度在1mm-12mm之间。所述电极122与环状骨架121之间通过缝合、焊接、缠绕或者钢套的方式连接。
所述锚定件130包括锚定主体131，所述锚定主体131侧面一周间隔设置多个锚刺，所述锚刺朝向近心端外侧方向延伸。
根据锚定件130不同的结构有以下几种实施方式：
锚定件130的第一种实施方式：所述锚定主体131为圆筒状结构，所述锚刺在圆筒状结构外壁一圈均匀设置。所述圆筒状结构的锚定主体131的远端和近端中至少一端封闭；或者圆筒状结构的锚定件130的远端和近端都开口。
锚定件130的第二种实施方式：所述锚定主体131为翻折结构，所述翻折结构为由消融件120远端的中心向远心方向外侧延伸，并逐步反向翻折形成，所述锚刺在翻折结构外壁一圈均匀设置。所述翻折结构在翻折后向中心汇聚，形成近端封闭或近似封闭的锚定主体131；或者所述翻折结构在翻折后不向中心汇聚，形成近端开口的锚定主体131。
同样由于锚定件130起到锚定作用，则锚定件130的所述锚定主体131至少在与左心耳贴合的外壁面涂覆有绝缘涂层；或者所述锚定主体131外至少在 外壁面处设有绝缘膜；或者所述锚定主体131由金属丝或金属杆制成，至少在与左心耳内壁面贴合处或靠近左心耳内壁面的所述金属丝或金属杆穿套有绝缘套管。上述实施方式的绝缘结构跟密封件110相同，在此不再赘述。
所述锚定件130上设有多个用于在左心耳内壁上锚定的锚刺133，锚刺133设置在锚定主体131的外壁面上，沿锚定主体131外壁面一周均匀设置多个，根据锚刺133设置方式不同，有以下几种实施方式：
锚刺133与锚定件130连接的第一种实施方式：锚刺133可以直接固定在锚定主体131上，固定的方式为焊接等；
锚刺133与锚定件130连接的第二种实施方式：所述锚刺133也可以通过钢套与锚定件130固定连接在一起。
锚刺133与锚定件130连接的第三种实施方式：所述锚刺133与锚定件130一体结构，即锚刺133由锚定件130直接延伸形成。
锚刺133设置数量为6-9个，锚刺133张开角度在30°～60°之间，方向朝向近心端，锚刺133长度为0.5～4mm之间。
为了强化消融，所述锚刺133导电，且与射频源电连接，倒刺133可通过锚定件130的连接端部与射频源电连接，所述锚刺133可对与左心耳接触位置进行消融。
为了进一步阻隔血栓，所述密封件110、消融件120和锚定件130中，除了在密封件110内部设有至少一个用于阻隔血栓的阻流膜112，也可以同时在消融件120或/和锚定件130中设置阻流膜122和阻流膜132，阻流膜1120、122、132周边采用缝合方式通过多个缝合点固定在它们的内部，阻流膜1120、122、132可为PET或PTFE覆膜。阻流膜112、122、132设置的数量和位置根据实际需要，可以在1-5个。
密封件110与锚定件130表面采用绝缘涂层加缝合阻流膜112处理，一是可以阻挡左心耳内血栓进入左心房，二是可提高整个左心耳封堵消融装置的消融阻抗，减小整个左心耳封堵消融装置与血液、组织的导电接触表面积，避免过多的能量散失在血液或非靶点组织处，从而集中能量用于消融件120对应靶点处的组织射频消融，同时可减小消融过程对非消融区域组织的损伤；消融件120包括环状骨架121和其上连接的电极122，该结构适应左心耳口部结构， 与靶向消融区域紧密贴附，实现左心耳口部内壁周向密集多点消融，大大提高消融成功率，缩短手术时间；同样锚定件130的锚刺133采用金属材料制成，主要用来加强稳固整个左心耳封堵消融装置结构在左心耳内的位置，也可以用于消融，和消融件120的电极122实现双重消融的功能。
消融件120上的电极122与射频源的电连接包括两种方式：
第一种电连接方式是通过在所述密封件110上设有连接端113，所述连接端113分别与消融件120的电极122和射频源电连接。连接端113是密封件110的金属丝汇聚形成的端头结构，也可以另外固定在密封件110端面上结构。所述连接端设置在密封件110近心端中心，连接端113与消融件120的电极122电连接方式有两种：一种是所述连接端113通过密封件110的网格骨架111与消融件120的电极122电连接；第二种是所述密封件110中心设有过渡连接件，用于连接端与消融件120的电极122电连接。
第二种电连接方式是所述电极122直接与射频源电连接，即射频源与电极之间直接通过导线连接，电流不会经过消融装置的其他部分传导；为了将射频能量能够集中在电极122与左心耳内壁贴合的面，而不会通过电极122与消融件的环状骨架121的接触而向封堵消融装置的其他部分传导，所述消融件120上至少与电极122接触的部分绝缘；电极122是消融件120中用于消融左心耳内壁的，消融件120其他部分主要起支撑作用。其中，所述消融件120包括与左心耳内壁贴合一周的起支撑作用的环状骨架121，所述环状骨架121的环形外壁面一圈设有电极122，电极122连接方式为直接连接方式：所述电极122直接连接射频源。
由于本发明的装置结构实施方式有多种，以下通过具体实施例进行详细说明：
实施例1：
如图1至图3所示，左心耳封堵消融装置由三部分构成：密封件110、消融件120和锚定件130。其中密封件110位于装置近端区域，进一步包含一网格骨架111、一层或多层阻流膜112及连接端113；所述阻流膜112采用缝合方式固定在网状骨架111内部，阻流膜112可选自PET或PTFE覆膜；连接端113位于近端端面中心，优先选用螺栓栓头，通过该连接端113连接一输送导 线，该输送导线可通过连接端113将射频源的射频能量传送到消融件120的电极122。
如图1至图2所示，本实施例中，密封件110、消融件120与锚定件130三者一体结构，即密封件110的网格骨架111、消融件120的环状骨架121以及锚定件130的锚定主体131为一体结构，密封件110、消融件120与锚定件130三部分直径相同，整体装置呈现圆塞状结构。本实施例整体采用金属丝编织成密封件110、消融件120与锚定件130一体结构的三部分，而后定型而成，密封件110上设置的连接端113收束于近端端面的金属骨架头端；封头134收束锚定件130的远端面金属骨架头端，如图1所示。
本实施例编织金属丝可为镍钛合金、钴铬合金、不锈钢或其他生物相容性良好的金属材料。优选超弹性形状记忆合金镍钛丝，其制作工艺与传统左心耳封堵器制作工艺相同，在此不再赘述。除了上述一体成型形成的一体结构，密封件110、消融件120与锚定件130三者一体结构还可以是通过焊接等方式直接固定在一起的结构。
所述密封件110为网格骨架111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致；该实施方式中，密封件110是塞入左心耳的左心耳颈部中，密封件110直径与左心耳的内径一致，并且密封件110采用筒状结构，筒状结构的外壁面为密封面。
密封件110封闭左心耳通过设置在其内部的阻流膜112实现。阻流膜112周边采用缝合方式通过多个缝合点固定在网格骨架111内部，阻流膜112可为PET或PTFE覆膜。
如图1至图2所示，消融件120位于三者的中间区域，所述消融件120包括与左心耳内壁贴合一周的环状骨架121，该环状骨架121为消融件120的主体支撑结构，为金属丝编织形成相互交叉的网格状。环状骨架121上固定连接电极122，所述电极122可通过缝合、焊接、缠绕或者钢套固定在环状骨架121上，电极122通过环状骨架121连接连接端113，从而与射频源电连接。
本实施例中，电极122选择单圈电极，而单圈电极可以选择由多个单电极在环状骨架周向上连续排布形成的环状结构，还可以为独立围绕环状骨架成环的环电极，本实施例选择环电极。
电极122的轴向长度在1-12mm之间，本实施例优选5mm。如图1所示，消融件120内也可设置一层或多层阻流膜123。
如图1至图2所示，锚定件130位于装置的远端，包含一锚定主体131、阻流膜132、锚刺133以及封头134；所述锚定主体131为筒状结构，优选为圆筒状结构，即锚定件130直径与左心耳内径基本相同，锚定件130外壁面与左心耳内壁之间接触形成摩擦力，锚定件130可以直接用于锚定。
优选在锚定件130的锚定主体131上设有多个用于在左心耳内壁上锚定的锚刺133，所述锚刺133在筒状结构外壁一圈均匀设置，装置植入后，锚刺刺入左心耳内壁锚定，采用锚刺锚定稳定性更好。所述筒状结构的锚定主体131的远端封闭、近端与消融件120连成一体。
如图1所示，在锚定主体131内设置有至少一个阻流膜132，阻流膜132周边采用缝合方式固定在锚定主体131内部，例如PET或PTFE覆膜。
锚刺133与锚定主体131为一体结构或固定连接结构，本实施例采用钢套135将锚刺133与锚定主体131连接在一起，位置处于锚定件130的远端，数量为6-9个，锚刺133张开角度在30°～60°之间，方向朝向近端，锚刺133长度为0.5～4mm之间，封头134位于锚定件130的远端面中心。锚定区倒刺结构，主要用来加强稳固整个左心耳封堵消融装置结构，也可以用于消融，和消融件120的电极实现双重消融的功能。
进一步优选的实施方式是将密封件110的网格骨架111至少在与左心耳贴合的密封面涂覆有绝缘涂层，绝缘涂层是采用绝缘材料涂覆的方式在网格骨架111上形成一层或多层的绝缘材料，隔绝网格骨架111与左心耳接触导电；密封件110的绝缘也可采用绝缘套管套装到网格骨架111的每根金属丝或金属杆上。密封件110的密封通过设置在其内部的阻流膜112实现。阻流膜112周边采用缝合方式固定在网格骨架111内部，例如PET或PTFE覆膜。
进一步优选的实施方式是将锚定件130的锚定主体131至少在与左心耳贴合的密封面涂覆有绝缘涂层，绝缘涂层是采用绝缘材料涂覆的方式在锚定主体131上形成一层或多层的绝缘材料，隔绝锚定主体131与左心耳接触导电；锚定件130的绝缘也可采用绝缘套管套装到锚定主体131的每根金属丝或金属杆上。
本实施例中，在封堵装置100除消融件120的电极122以外的与心耳内壁面接触的外表面都进行绝缘处理，可提高整个左心耳封堵消融装置的消融阻抗，减小整个左心耳封堵消融装置与血液、组织的导电接触表面积，避免过多的能量散失在血液或非靶点组织处，从而集中能量用于消融区靶点处的组织射频消融，同时可减小消融过程对非消融区组织的损伤。消融件120的电极122为不间断的环状电极，该结构适应左心耳口部结构，与靶向消融区实现紧密的贴附，同时实现左心耳口部内壁周向密集环状消融，大大提高消融成功率，缩短手术时间。
如图3所示为本实施例左心耳封堵消融装置100释放在左心耳内的状态。手术过程中，密封件110上的连接端113可通过螺栓方式连接输送导线2，输送导线2表面绝缘，绝缘方式采用绝缘涂层或套有一高分子绝缘材料的绝缘套管，优先选用PTFE、FEP、ETFE或PFA套管，收入一直径较小的输送鞘管3中，然后通过股静脉穿刺进入下腔静脉，进入右心房，再通过房间隔穿刺进入左心房6。左心耳封堵消融装置100释放时，通过造影和超声手段定位左心耳封堵消融装置在左心耳7内的位置，保证释放后锚定件130释放在左心耳7内部，锚刺133钩入左心耳7内壁；消融件120的环状电极122与左心耳7靠近入口处的内壁紧密贴合，密封件110中的阻流膜将左心耳7口部封堵住，阻止血流进入左心耳7内及左心耳7内血栓流入左心房6。左心耳封堵消融装置100释放在左心耳7内后，将输送导线2的尾端连接射频源---射频消融发生器，调整射频消融参数，通过输送导线2将射频消融能量传递给左心耳封堵消融装置100的连接端113，连接端113接收射频消融能量传递给消融件120，从而实现消融手术，因本实施例消融件120采用网格编织方式，网格比较密集，从而可以实现左心耳7开口部内壁周向所有靶点的消融阻断。消融手术结束后，将输送导线2与左心耳封堵消融装置100解脱，左心耳封堵消融装置100留在左心耳7内实现长期的封堵性能。本发明可在一个手术中利用左心耳封堵消融装置100自身结构实现左心耳封堵，并实现左心耳口部完全消融阻断，从而增加房颤的消融成功率。
如图4所示，在实施例1的另一种实施方式中，消融件120的电极122可设置为点状电极。
如图5所示，在实施例1的另一种实施方式中，消融件120的电极122可设置为杆状电极。
如图6所示，在实施例1的另一种实施方式中，消融件120的电极122可设置为在环状骨架周向上的单圈间断的环状电极。
如图7所示，在实施例1的另一种实施方式中，消融件120的电极122可设置为两圈或两圈以上的环状电极，所述环状电极可以是连续的，或者间断的，或者两者的组合；所述多圈环状电极122在环状骨架轴向上可平行设置或者交错排列。
实施例2：
如图8至图9所示，本实施例的左心耳封堵消融装置100也由三部分构成：密封件110、消融件120和锚定件130。所述密封件110、消融件120与锚定件130三者一体结构。所述密封件110为网格骨架111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致。所述锚定主体131为圆筒状结构，所述圆筒状结构的远端封闭、近端与消融件120连成一体。
本实施例密封件110、消融件120和锚定件130结构同实施例1，其主要区别是：至少在所述环状骨架121外在与电极122接触的外壁面处设有将所述电极122与环形骨架121隔绝的绝缘膜101。如图8所示，所述绝缘膜101可为球面形覆膜，将所述封堵装置100除消融件120上环状骨架121与电极122的接触点外的外表面全部或者部分包裹在绝缘膜101内，此处全部指除与电极接触部分，其余结构的全部；球面形覆膜指至少在远端端面和远端部分形成包裹。本实施例绝缘覆膜101表面为致密结构，无孔，可实现有效绝缘，所述绝缘膜101可以作为电极122与封堵装置之间的绝缘屏障，防止电极122上的射频能量向封堵器的中心方向传递，从而射频能量能够集中在左心耳壁上，进一步防止电极122上的射频能量流失，提高消融效率。当绝缘膜101也同时设置在密封件110近端，此处设置绝缘膜101作为阻隔件，起到阻隔血栓的作用，同时，密封件110中的阻流膜可以设置也可以不设置。
在实施例2的另一种实施方式中，如图9所示，所述绝缘膜101可为环面形覆膜，设置在所述消融件120上的环状骨架121与电极122之间，形成电极 122与封堵装置之间的绝缘屏障。所述的在网格骨架111或/和锚定主体131可以采用如实施例1上涂覆绝缘涂层或者穿插绝缘套管。
在本实施例中，绝缘膜101可采用缝合、热压、喷涂、浸沾等方式固定在网格结构111、环状骨架121或锚定主体131外表面或者所述网格结构内外表面同时固定绝缘膜101，所述绝缘膜101可以是FEP、ETFE、PFA、PTFE、硅胶、PEEK等绝缘材料制成。
另外与实施例1区别：如图9所示，锚刺133的位置比较靠近锚定件130的近端。
本实施例中的电极122也可如实施例1所示，设置点状电极，杆状电极，单圈或多圈平行排列或交错排列的，间断的或者连续的环状电极，或者以上电极122的组合。
实施例3：
如图10至图11所示，本发明实施例3的左心耳封堵消融装置100由三部分构成：密封件110、消融件120和锚定件130。所述密封件110、消融件120与锚定件130三者一体结构。所述密封件110为网格骨架111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致。所述锚定主体131为圆筒状结构，所述圆筒状结构的近端封闭、近端与消融件120连成一体，远端开口。基本结构同实施例1、2，绝缘处理方式可与实施例1、2相同。
锚刺133与锚定主体131为一体结构或固定连接在一起，可以通过钢套135将锚刺133固定在锚定主体131上，也可以直接固定在锚定主体131上。密封件110的连接端113位置和作用与实施例1相同，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点外的外表面均可做绝缘处理，所述绝缘处理方式及消融件120的电极122形式及设置方式可与实施例1或2相同。
如图11所示，本实施例与实施例1、2的区别为：本实施例左心耳封堵器消融装置100其锚定区远端面为开口结构，即锚定主体131为圆筒状结构，锚定件130的远端开口，无封头。
本实施例中的电极122也可如实施例1所示，设置点状电极、杆状电极， 电极单圈排布或多圈平行排列或交错排列，还可以设置为间断排布的环电极或者连续的环电极，还可以是以上电极的组合。
其余结构同实施例1、2。在此不再赘述。
实施例4：
如图12所示，本发明实施例4左心耳封堵消融装置100也同样由三部分构成：密封件110、消融件120和锚定件130。三部分一体结构。所述密封件、消融件120与锚定件130三者一体结构。所述密封件110为网格骨架111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致。所述锚定主体为锥台状结构。
密封件110、消融件120和锚定件130均采用激光切割热定型的方式制成，其中密封件110位于近端位置，进一步包含切割形成的网格骨架111和连接端113；连接端113位置和作用与实施例1相同。消融件120位于中间区域，消融件120上设置有电极122，所述电极122的设置与实施例1相同；锚定件130位于远端，包括切割形成的锚定主体131，锚定主体131外壁面上设置锚刺133，锚刺133与锚定主体131为一体结构，所述锚定件130的绝缘处理方式可与实施例1或2相同，在此不再赘述。
如图12所示，本实施例与上述实施例1-2的区别为：本实施例左心耳封堵器消融装置其锚定区远端面为开口结构，即锚定主体为圆筒状结构，锚定件130的远端开口，无封头。且左心耳封堵器消融装置100外表面也可以是带锥度的或球面型。即锚定件130的远端逐步向内收缩，形成远端开口直径小于锚定件130直径。
实施例5：
如图13至图14所示，本发明实施例五左心耳封堵消融装置100由三部分构成：密封件110、消融件120和锚定件130。所述密封件110与消融件120通过连接件30连接，所述消融件120与锚定件130二者一体结构。即所述心耳封堵消融装置整体金属骨架为双盘结构，包括近心盘和远心盘。近心盘、远心盘之间通过连接件30连接。其中近心盘采用镍钛丝编织热定型而成，形成 密封件110；远心盘包括消融件120与锚定件130，同样采用镍钛编织定型而成。
所述密封件110为网格骨架111形成的用于将左心耳入口处密封的密封盘，所述密封盘与左心耳入口处形状配合一致。该实施方式中，密封件110是压住左心耳入口处，密封件110直径稍大于左心耳的内径，并且密封件110采用轴向长度较短的圆盘状结构，圆盘状结构能直接压住入口。
密封件110的主体为网格骨架111，在网格骨架111内设置一层或多层阻流膜112，密封件110的端面上设有连接端113；所述阻流膜112可设置在密封件110内，或在密封件110外表面覆一层高分子的阻流膜112，阻流膜112优先选用PET或PTFE膜。连接端113位于近心盘近端盘面中心，例如螺栓栓头，用于连接输送导线及接收射频消融能量。
消融件120位于远心盘近端，为一圆环网状的环状骨架121，轴向长度为5mm，所述环状骨架121表面固定有电极122，如图13所示，所述电极122为单圈设置的不间断的环状电极，也可设置与实施例1相同的点状电极，杆状电极，或者多圈设置的间断和/或不间断的环状电极。在优选的实施方式中，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点之外的外表面部分或者全部进行绝缘处理，所述绝缘处理方式可与实施例1相同，采用涂层技术或者穿插绝缘套管，该涂层可采用涂覆的方式固定在网格骨架111上，也可为绝缘套管，例如采用FEP、ETFE、PFA、PTFE材料的绝缘套管；或者采用与实施例2相同的方式，采用球面形绝缘膜完全包裹封堵装置100时，即在密封件110或锚定件130外表面，或者内外表面同时固定绝缘膜，设置密封件110近端或/和远端的绝缘膜、设置在锚定件130远端的绝缘膜作为阻隔件可以起到阻隔血栓的作用；或者采用实施例1与实施例2的两种方式结合的绝缘方式。
本实施例中的电极122也可如实施例1所示，设置点状电极，杆状电极，单圈或多圈平行排列或交错排列的，间断的或者连续的环状电极，或者以上电极的组合。
锚定件130位于远心盘远端，包含一锚定主体131、阻流膜132、锚刺133及封头134。所述锚定主体131表面可不做绝缘处理；阻流膜132周边采用缝 合方式固定在锚定主体131内部，例如PET或PTFE覆膜。锚刺133与锚定主体131为一体或连接结构，本实施例采用钢套135将锚刺133与锚定主体131连接在一起，锚刺133位置处于锚定件130的远端，数量为6-9个，锚刺张开角度在30°～60°之间，方向朝向近端，锚刺长度为0.5～4mm之间，封头134位于远端的端面中心。所述锚刺133至少外表面导电，且与射频源电连接来对所述锚刺133与左心耳接触位置进行消融，本实施例中锚刺133为导电的金属材料制成，表面无绝缘。
密封件110的网格骨架111与消融件120的环状骨架121是通过连接件30连接在一起的，可以采用焊接或压紧的方式连接在一起。连接件30采用柱状结构，连接件30设置在消融件120近端的端面中心与密封件110远端的端面中心。
本实施例左心耳封堵消融装置各部分的绝缘与导电设计目的与实施例1相同。如图15A所示，本实施例左心耳封堵消融装置100手术过程中释放到左心耳7内绝缘钢缆解脱前的形态，锚定件130锚定在左心耳7内，消融件120与左心耳7的口部紧密贴附；密封件110将左心耳7的入口处封堵住，阻止血流进入左心耳7内及左心耳7内血栓流入左心房6。然后将输送导线2尾端连接射频消融发生器设备，调整射频消融参数，通过钢缆将射频消融能量传递给左心耳封堵消融装置100的密封件端头113，端头113接收射频消融能量传递给消融件120的电极122上，从而实现消融手术。
在本实施例的另一种实施方式中，如图15B所示，本实施例左心耳封堵消融装置100手术过程中释放到左心耳7内绝缘钢缆解脱前的形态，锚定件130锚定在左心耳7内，消融件120与左心耳7的口部紧密贴附；而密封件110仍在鞘管3中，此时左心耳封堵消融装置100处于部分释放的状态，锚定件上的阻流膜可以起到部分封堵作用。然后将输送导线2尾端连接射频消融发生器设备，调整射频消融参数，通过钢缆将射频消融能量传递给左心耳封堵消融装置100的密封件端头113，端头113接收射频消融能量传递给消融件120的电极122上，从而实现消融手术。消融完成后，关闭射频消融发生设备，再将密封件110完全释放出来，完全释放的密封件110将左心耳7的入口处封堵住，阻止血流进入左心耳7内及左心耳7内血栓流入左心房6。这种实施方式无需 对密封件进行绝缘处理。
实施例6：
如图16所示，本实施例6左心耳封堵消融装置100包括密封件110、消融件120和锚定件130三部分。所述密封件110与消融件120二者一体结构，所述消融件120与锚定件130通过连接件30连接；所述密封件110为网格骨架111形成的用于将左心耳入口处与左心耳颈部同时密封的密封塞盘，所述密封塞盘与左心耳入口处和左心耳颈部形状配合一致。或者密封件110是压住左心耳入口处的密封盘，密封件110直径稍大于左心耳的内径，并且密封件110采用轴向长度较短的圆盘状结构，圆盘状结构能直接压住左心耳入口。
具体讲，所述心耳封堵消融装置为双盘结构，包括近心盘和远心盘。近心盘、远心盘之间通过连接件30连接。其中近心盘包括密封件110与消融件120；远心盘为锚定件130；所述近心盘和远心盘均采用镍钛丝编织热定型而成。
密封件110与与消融件120一体结构形成一个瓶塞状，密封件110的直径大于消融件120直径，消融件120直径由近端向远端逐步减小，形成锥台状。
所述密封件110位于近心盘的近端，密封件的主体为网格骨架111，在网格骨架111内设置一层或多层阻流膜112，密封件110的端面上设有连接端113；所述阻流膜112可设置在密封件110内，或在密封件110外表面覆一层高分子的阻流膜112，阻流膜112优先选用PET或PTFE膜。连接端113位于近心盘10近端盘面中心，例如螺栓栓头，用于连接输送导线及接收射频消融能量。
消融件120位于近心盘的远端，包括环状骨架121，所述环状骨架121表面固定有电极122，固定方式可与实施例1相同，如图16所示，所述电极122为单圈设置的不间断的环状电极，也可设置与实施例1相同的点状电极，杆状电极，或者多圈设置的间断和/或不间断的环状电极。所述电极122通过环状骨架121、连接端113与射频源电连接。
在优选的实施方式中，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点外的外表面部分或者全部进行绝缘处理，所述绝缘处理方式可与实施例1相同，采用涂层技术或者穿插绝缘套管，该涂层可采用涂覆的方式固定在网格骨架上，也可为绝缘套管，例如采用FEP、ETFE、PFA、PTFE 材料的绝缘套管；或者采用与实施例2相同的方式，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点外的外表面部分或者全部包裹绝缘膜，所述覆膜为环状覆膜，或者将整个封堵装置的部分或全部均包裹在球面形绝缘膜中，当采用球面形绝缘膜完全包裹近端盘时，即在近端盘外表面，或者内外表面同时固定绝缘膜，设置近端盘近端或/和远端的绝缘膜、设置在锚定件130远端的绝缘膜作为阻隔件可以起到阻隔血栓的作消融件120内部可设有一层或多层阻流膜123。
当采用绝缘涂层或者绝缘套管的绝缘方式时，如图17所示，还可以在锚定件130的外表面设置一层或多层阻流膜132，所述阻流膜132将锚定件的部分或者整体包裹在阻流膜内，所述阻流膜132可选自球面形或者环形半渗透膜或者不渗透膜；通过缝合或者胶粘于所述锚定件130的外表面，所述阻流膜132可进一步阻挡血栓，并且增大锚定件与左心耳内壁的接触面积，避免局部受力过大造成对左心耳腔壁的损伤。
本实施例中的电极122也可如实施例1所示，设置点状电极、杆状电极，单圈或多圈平行排列或交错排列的，间断的或者连续的环状电极，或者以上电极的组合。
锚定件130位于远心盘的远端，包含锚定主体131、一层或多层阻流膜132、锚刺133及封头134。所述锚定主体为圆筒状结构。所述圆筒状结构的远端和近端中两端都封闭，形成圆柱状结构。
其余结构同前述实施例，在此不再赘述。
实施例7：
如图18至图19所示，本实施例7左心耳封堵消融装置100包括密封件110、消融件120和锚定件130三部分。所述密封件110与消融件120二者一体结构，所述消融件120与锚定件130通过连接件30连接；所述密封件110为网格骨架111形成的用于将左心耳入口处与左心耳颈部同时密封的密封塞盘，所述密封塞盘与左心耳入口处和左心耳颈部形状配合一致。也可采用密封盘，密封盘与消融件120一体结构。密封件110与消融件120的结构同实施例6，在此不再赘述。本实施例中的电极122也可如实施例1所示，设置点状电 极，杆状电极，单圈或多圈平行排列或交错排列的，间断的或者连续的环状电极，或者以上电极的组合。
与实施例6的区别：所述锚定主体为翻折结构，所述翻折结构为由消融件120远端的中心向远心方向外侧延伸，并逐步反向翻折形成，所述锚刺在翻折结构外壁一圈均匀设置。具体结构为：锚定件130为编织成型或者激光切割的远端开口结构，由消融件120远端中心的连接件30处向远心方向延伸形成内部支撑段，然后反向翻折形成锚定件130。所述翻折结构在翻折后向中心汇聚，形成封闭结构。
在另外的实施例中，还可以是所述翻折结构在翻折后不向中心汇聚，形成近端开口的锚定主体。近端开口朝向消融件120，锚定件130的近端跟消融件120留有间距。近端开口可以分为向中心收缩的半开口、不向中心收缩的全开口结构。所述锚定主体可选自如图18所示的网状结构，也可以如图20至图22所示，所述锚定件130的锚定主体131为多根支撑杆形成的框架结构，支撑杆既可以是每根之间相互独立的简单线性结构，也可以是相互交联形成的复杂结构。
如图19和图22所示，当采用绝缘涂层或者绝缘套管的绝缘方式时，还可以在锚定件130的外表面设置一层或多层阻流膜132，所述阻流膜132将锚定件的部分或者整体包裹在阻流膜132内，所述阻流膜132可选自球面形或者环形半渗透膜或者不渗透膜；通过缝合或者胶粘于所述锚定件130的外表面，所述阻流膜132可进一步阻挡血栓，并且增大锚定件与左心耳内壁的接触面积，避免局部受力过大造成对左心耳腔壁的损伤。
其余结构同实施例1-6。在此不再赘述。
实施例8：
如图23所示，与前述实施例不同之处在于，本实施例左心耳封堵消融装置100包括密封件110、消融件120和锚定件130三部分。但如本图所示，本实施例左心耳封堵消融装置骨架结构为三盘结构，包括近心盘、中间盘、远心盘及它们之间的连接件30。即所述密封件110与消融件120之间、消融件120与锚定件130之间分别通过连接件30连接。
其中近心盘为密封件110，采用镍钛丝编织热定型而成，包括网格骨架111、一层或多层阻流膜112及连接端113；阻流膜和连接端的设置与实施例1相同。
中间盘为消融件120，采用镍钛丝编织热定型而成，包括环状骨架121，所述环状骨架121表面固定有电极122，如图23所示，所述电极122为单圈设置的不间断的环状电极，也可设置与实施例1相同的点状电极，杆状电极，或者多圈设置的间断和/或不间断的环状电极。在优选的实施方式中，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点外的外表面部分或者全部进行绝缘处理，所述绝缘处理方式可与实施例1相同，采用涂层技术或者穿插绝缘套管，该涂层可采用绝缘材料涂覆的方式固定在网格骨架上，也可为绝缘套管，例如采用FEP、ETFE、PFA、PTFE材料的绝缘套管；或者采用与实施例2相同的方式，所述封堵装置100上除消融件120上环状骨架121与电极122的接触点外的外表面部分或者全部包裹绝缘膜，所述绝缘膜与实施例2相同。
本实施例中的电极122也可如实施例1所示，设置点状电极，杆状电极，单圈或多圈平行排列或交错排列的，间断的或者连续的环状电极，或者以上电极的组合。
远心盘为锚定件130，采用镍钛丝编织而成或者管状体激光切割而成，包含一锚定主体130、一层或多层阻流膜132、锚刺结构133及封头134。所述锚定主体130以及封头134以及阻流膜132的设置与实施例7相同。锚刺133与实施例1的连接方式相同，通过钢套135固定在金属丝上。当采用绝缘涂层或者绝缘套管的绝缘方式时，还可以在锚定件130的外表面设置一层或多层阻流膜132，所述阻流膜132将锚定件的部分或者整体包裹在阻流膜内，所述阻流膜132可选自球面形或者环形半渗透膜或者不渗透膜；通过缝合或者胶粘于所述锚定件130的外表面，所述阻流膜132可进一步阻挡血栓，并且增大锚定件与左心耳内壁的接触面积，避免局部受力过大造成对左心耳腔壁的损伤。
实施例9：
如图24至图26所示，左心耳封堵消融装置由三部分构成：密封件110、消融件120和锚定件130。其中密封件110位于近端区域，进一步包含一网格 结构111、一层或多层阻流膜112及连接端113；所述阻流膜112采用缝合方式固定在网状金属丝骨架111内部，阻流膜112可选自PET或PTFE覆膜；所述密封件110的近端设有与输送器可拆卸连接的连接端。连接端113位于近端的端面中心，优先选用螺栓栓头。
如图24至图25所示，本实施例中，密封件110、消融件120与锚定件130三者一体结构，即密封件110的网格结构111、消融件120的环状骨架121以及锚定件130的锚定主体131为一体结构，密封件110、消融件120与锚定件130三部分直径相同，整体装置呈现圆塞状结构。本实施例整体采用金属丝编织成密封件110、消融件120与锚定件130一体结构的三部分，而后定型而成，密封件110上设置的连接端113收束于近端端面的金属骨架头端；封头134收束锚定件130的远端面金属骨架头端，如图1所示。本实施例编织金属丝可为镍钛合金、钴铬合金、不锈钢或其他生物相容性良好的金属材料。优选超弹性形状记忆合金镍钛丝，其制作工艺与传统左心耳封堵器制作工艺相同，在此不再赘述。除了上述一体成型形成的一体结构，密封件110、消融件120与锚定件130三者一体结构还可以是通过焊接等方式直接固定在一起的结构。
所述密封件110为网格结构111形成的用于将左心耳颈部密封的密封塞，所述密封塞与左心耳颈部形状配合一致；该实施方式中，密封件110是塞入左心耳的左心耳颈部中，密封件110直径与左心耳的内径一致，并且密封件110采用筒状结构，筒状结构的外壁面为密封面。
密封件110封闭左心耳通过设置在其内部的阻流膜112实现。阻流膜112周边采用缝合方式通过多个缝合点固定在网格结构111内部，阻流膜112可为PET或PTFE覆膜。
如图24至图25所示，消融件120位于三者的中间区域，所述消融件120包括与左心耳内壁贴合一周的环状骨架121，该环状骨架121为消融件120的主体支撑结构，为金属丝编织形成相互交叉的网格状。环状骨架121上固定连接电极122，所述电极122可通过缝合或者缠绕固定在在环状骨架121上，固定在环状骨架121的电极122直接与射频源连接，即将电极122直接通过导线与输送器上导线连接射频源，射频能量无需经过封堵装置的金属骨架，在本实施例中，环状的电极122之间无间隔，可通过至少一根导线与射频源相连接， 导线与电极122之间通过焊接或者钢套固定连接。进一步优选的实施方式是至少将电极122与消融件120的环状骨架121接触的位置进行绝缘处理，此时能够将射频能量集中在用于消融的电极122上，达到更好的消融效果。所述绝缘处理的方式为在与电极122接触的金属环状骨架121外表面涂覆绝缘涂层，或者在所述环状骨架121上穿插绝缘套管，绝缘套管包裹在所述环状骨架121的外表面，涂层或套管材料可选自FEP/ETFE/PFA。本实施例中，电极122选择单圈电极，而单圈电极可以选择由多个单电极在环状骨架周向上连续排布形成的环状结构，还可以为独立围绕环状骨架成环的环电极，本实施例选择环电极。
电极122为的轴向长度在1-12mm之间，本实施例优选5mm。如图1所示，消融件120内也可设置一层或多层阻流膜123。
如图24至图25所示，锚定件130位于装置的远端，包含一锚定主体131、阻流膜132、锚刺133以及封头134；所述锚定主体131为筒状结构，优选为圆筒状结构，即锚定件130直径与左心耳内径基本相同，锚定件130外壁面与左心耳内壁之间接触形成摩擦力，锚定件130可以直接用于锚定。
优选在锚定件130的锚定主体131上设有多个用于在左心耳内壁上锚定的锚刺133，所述锚刺133在筒状结构外壁一圈均匀设置，装置植入后，锚刺刺入左心耳内壁锚定，采用锚刺锚定稳定性更好。所述筒状结构的锚定主体131的远端封闭、近端与消融件120连成一体。
如图24所示，在锚定主体131内设置有至少一个阻流膜132，阻流膜132周边采用缝合方式固定在锚定主体131内部，例如PET或PTFE覆膜。
锚刺133与锚定主体131为一体结构或固定连接结构，本实施例采用钢套135将锚刺133与锚定主体131连接在一起，位置处于锚定件130的远端，数量为6-9个，锚刺133张开角度在30°～60°之间，方向朝向近端，锚刺133长度为0.5～4mm之间，封头134位于锚定件130的远端面中心。锚定区倒刺结构，主要用来加强稳固整个左心耳封堵消融装置结构
封堵装置100在消融件环形骨架121与消融的电极122接触的表面采用绝缘涂层或者在环形骨架121消融件的金属丝上穿插绝缘套管，可提高整个左心耳封堵消融装置的消融阻抗，减小左心耳封堵消融装置整个与血液、组织的导 电接触表面积，避免过多的能量散失在血液或非靶点组织处，从而集中能量用于消融区靶点处的组织射频消融，同时可减小消融过程对非消融区组织的损伤。消融件电极122为不间断的环状电极，该结构适应左心耳口部结构，与靶向消融区实现紧密的贴附，同时实现左心耳口部内壁周向密集环状消融，大大提高消融成功率，缩短手术时间。
如图26所示为本实施例左心耳封堵消融装置100释放在左心耳内的状态。手术过程中，密封件110上的连接端113可通过螺栓方式连接输送导管2，收入一直径较小的输送鞘管3中，然后通过股静脉穿刺进入下腔静脉10，进入右心房9，再通过房间隔穿刺进入左心房6。左心耳封堵消融装置100释放时，通过造影和超声手段定位左心耳封堵消融装置在左心耳7内的位置，保证释放后锚定件130释放在左心耳7内部，锚刺133钩入左心耳7内壁；消融件120与左心耳7靠近入口处的内壁紧密贴合，密封件110中的阻流膜将左心耳7口部封堵住，阻止血流进入左心耳7内及左心耳7内血栓流入左心房6。左心耳封堵消融装置100释放在左心耳7内后，将与电极122连接的输送导线4的尾端连接射频源---射频消融发生器，调整射频消融参数，通过输送导线4将射频消融能量传递给左心耳封堵消融装置100的电极122，电极122接收射频消融能量，从而实现消融手术，消融结束后，可将输送导线4与电极122解脱。输送导线4与输送导管2两者外表面之间是绝缘的，输送导管2和/或输送导线4表面绝缘，绝缘方式采用绝缘涂层或套有一高分子绝缘材料的绝缘套管，优先选用PTFE、FEP、ETFE、PFA或PEEK(聚醚醚酮)套管，因本实施例消融件电极122采用不间断的环电极，从而可以实现左心耳口部内壁周向所有靶点的消融阻断，消融手术结束后，将输送导管2与左心耳封堵消融装置100解脱，左心耳封堵消融装置100留在左心耳7内实现长期的封堵性能。本发明可在一个手术中利用左心耳封堵消融装置100自身结构先后实现左心耳封堵与高效的实现左心耳口部完全消融阻断，从而恢复窦性心律。
如图27所示，在实施例9的另一种实施方式中，消融件120的电极122可设置为点状电极。
如图28所示，在实施例9的另一种实施方式中，消融件120的电极122可设置为杆状电极。
如图29所示，在实施例9的另一种实施方式中，消融件120的电极122可设置为在环状骨架周向上的单圈间断的环状电极。
如图30所示，在实施例9的另一种实施方式中，消融件120的电极122可设置为两圈或两圈以上的环状电极，所述环状电极可以是连续的，或者间断的，或者两者的组合；所述多圈环状电极122在环状骨架轴向上可平行设置或者交错排列。
分散的点状电极，杆状电极或者间断的环状电极可通过一根导线串联后再通过输送导线与射频电源连接，或者通过多根导线与射频电源连接。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。

Claims (22)

  1. 一种左心耳封堵消融装置，包括位于近端的用于封闭左心耳的密封件、位于远端的用于将装置锚定在左心耳中的锚定件；其特征在于，装置还包括用于对左心耳内壁进行消融的消融件；
    所述消融件包括用于与左心耳内壁贴合的电极和环状骨架，所述电极与射频源电连接。
  2. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述消融件的环状骨架的环形外壁面至少设置一圈电极，所述电极通过环状骨架与射频源电连接。
  3. 根据权利要求2所述的左心耳封堵消融装置，其特征在于，所述密封件上设有连接端，所述连接端分别与消融件的电极和射频源电连接。
  4. 根据权利要求3所述的左心耳封堵消融装置，其特征在于，所述连接端设置在密封件近端端面中心，所述连接端通过密封件的网格骨架与消融件的电极电连接；
    或者所述密封件中心设有过渡连接件，用于连接端与消融件的电极电连接。
  5. 根据权利要求1-4中任意一项所述的左心耳封堵消融装置，其特征在于，所述环状骨架在与电极接触的部分不绝缘，其余部分至少在锚定件外表面绝缘。
  6. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述电极直接与射频源电连接；所述消融件上至少与电极接触的部分绝缘。
  7. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述密封件设有与所述左心耳内壁贴合的密封面。
  8. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述密封件、消融件与锚定件三者一体结构；
    或者所述密封件与消融件二者一体结构，所述消融件与锚定件通过连接件连接；
    或者所述密封件与消融件通过连接件连接，所述消融件与锚定件二者一体结构；
    或者所述密封件与消融件之间、所述消融件与锚定件之间分别通过连接件连接。
  9. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述密封件为金属网格骨架形成的密封盘；
    或者所述密封件为所述金属网格骨架形成的密封塞；
    或者所述密封件为所述金属网格骨架形成的密封塞盘，所述密封塞盘包括背向所述消融件的盘面、朝向所述消融件的盘底以及连接所述盘面和所述盘底的腰部。
  10. 根据权利要求4所述的左心耳封堵消融装置，其特征在于，所述网格骨架至少在与左心耳贴合的密封面涂覆有绝缘涂层；
    或者所述网格骨架外至少在密封面处设有绝缘膜；
    或者所述网格骨架由金属丝或金属杆制成，至少在密封面处的所述金属丝或金属杆穿套有绝缘套管。
  11. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述环状骨架的环形外壁面连续设置或间断设置有单圈电极或多圈电极，多圈电极中各圈电极之间在环状骨架轴向上平行排列或者交错排列。
  12. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述电极为独立围绕环状骨架成环的环电极；
    或者所述电极由多个单电极在环状骨架周向上连续排布或间隔排布形成的环状结构。
  13. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述电极与环状骨架之间通过缝合、焊接、缠绕或者钢套的方式连接。
  14. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述环状骨架为编织或切割制成的网状结构、杆状结构或框架结构中的至少一种。
  15. 根据权利要求1所述的左心耳封堵消融装置，其特征在于，所述锚定件包括锚定主体，所述锚定主体侧面一周间隔设置多个锚刺，所述锚刺朝向近心端外侧方向延伸。
  16. 根据权利要求15所述的左心耳封堵消融装置，其特征在于，所述锚刺至少外表面导电，且与射频源电连接。
  17. 根据权利要求15所述的左心耳封堵消融装置，其特征在于，所述锚定主体为圆筒状结构，所述锚定主体的远端和近端中至少一端封闭；或者圆筒状结构的锚定件的远端和近端都开口。
  18. 根据权利要求15所述的左心耳封堵消融装置，其特征在于，所述锚定主体为翻折结构，所述翻折结构为由消融件远心端的中心向远端方向外侧延伸，并逐步反向翻折形成，所述锚刺在翻折结构外壁一圈均匀设置。
  19. 根据权利要求18所述的左心耳封堵消融装置，其特征在于，所述翻折结构在翻折后向中心汇聚，形成近端封闭或近似封闭的锚定主体；
    或者所述翻折结构在翻折后不向中心汇聚，形成近端开口的锚定主体。
  20. 根据权利要求15所述的左心耳封堵消融装置，其特征在于，所述锚定主体的金属网格骨架至少在与所述左心耳贴合的外壁面涂覆有绝缘涂层；
    或者所述金属网格骨架外至少在所述外壁面处设有绝缘膜；
    或者所述金属网格骨架由金属丝或金属杆制成，所述金属网格骨架中至少在与所述左心耳内壁面贴合或靠近所述左心耳内壁面的所述金属丝或所述金属杆上穿套有绝缘套管。
  21. 根根据权利要求1所述的左心耳封堵消融装置，其特征在于，在密封件、消融件和锚定件中，至少在其中一个的径向上设有封闭左心耳的阻隔件。
  22. 据权利要求21所述的左心耳封堵消融装置，其特征在于，所述阻隔件为至少在密封件内部径向设有的至少一个阻流膜，所述阻流膜横向 设置并固定内壁上；
    或者所述阻隔件为至少在密封件近端或/和远端设置的横向封闭的绝缘膜；
    或者所述阻隔件为至少在锚定件远端或/和近端设置的横向封闭的绝缘膜。
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