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WO2018228383A1 - Appareil d'occlusion et d'ablation d'appendice auriculaire gauche - Google Patents

Appareil d'occlusion et d'ablation d'appendice auriculaire gauche Download PDF

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Publication number
WO2018228383A1
WO2018228383A1 PCT/CN2018/090854 CN2018090854W WO2018228383A1 WO 2018228383 A1 WO2018228383 A1 WO 2018228383A1 CN 2018090854 W CN2018090854 W CN 2018090854W WO 2018228383 A1 WO2018228383 A1 WO 2018228383A1
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WO
WIPO (PCT)
Prior art keywords
ablation
atrial appendage
left atrial
anchor
sealing
Prior art date
Application number
PCT/CN2018/090854
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English (en)
Chinese (zh)
Inventor
唐闽
张澍
王永胜
李建民
吴俊飞
赵亦伟
Original Assignee
诺芮医疗器械（上海）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN201710510388.3A external-priority patent/CN109124755A/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 WO2018228383A1 publication Critical patent/WO2018228383A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or 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 interventional medical devices, and 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 blocks the left atrial appendage, and then passes through the device. Radiofrequency ablation of the left atrial appendage.
  • 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.
  • Left atrial appendage is not only the most important part of atrial fibrillation due to its special morphology and structure, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can be electrically isolated by active left atrial appendage (left). Atrial appendage isolation, LAAI) benefits.
  • Radiofrequency ablation is one of the hotspots of atrial fibrillation today.
  • radiofrequency ablation can improve atrioventricular node or completely ablate the atrioventricular node and place a pacemaker to control ventricular rate; atrial ablation or ablation of the pulmonary vein (including point ablation, segmental ablation and ring) 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.
  • a left atrial appendage ablation device is provided to cooperate with atrial fibrillation ablation and stroke prevention.
  • a left atrial appendage ablation device comprising a seal at a proximal end of the device for closing a left atrial appendage, and an anchor at a distal end of the device for anchoring the device in the left atrial appendage
  • the device further comprising an ablation member for annular ablation of the inner wall of the left atrial appendage, wherein the proximal end is after the device is placed in the left atrial appendage, the device being near an end of the left atrium, The distal end is after the device is placed in the left atrial appendage, the device being remote from one end of the left atrium.
  • the ablation member is provided with an electrically conductive ablation surface for conforming to the inner wall of the left atrial appendage, the ablation surface being electrically connected to the radio frequency source.
  • the seal and the anchor member are insulated from an outer wall surface adjacent to or conforming to the inner wall of the left atrial appendage.
  • the seal is provided with a cover that is insulative and insulated from the inner wall of the left atrial appendage.
  • the sealing member, the ablation member and the anchor member are integrally formed; or the sealing member and the ablation member are integrally formed, the ablation member and the anchor
  • the fixing member is connected by the first connecting member; or the sealing member is connected to the ablation member by a second connecting member, the ablation member and the anchoring member are integrally formed; or the sealing member and the ablation
  • the pieces are connected by the second connecting member, and the ablation member and the anchor are connected by the first connecting member.
  • the sealing member is a sealing disk formed by a metal mesh skeleton; or the sealing member is a sealing plug formed by the metal mesh skeleton; or the sealing member is the metal mesh skeleton
  • a sealing plug is formed that includes a disk surface facing away from the ablation member, a disk bottom facing the ablation member, and a waist portion connecting the disk surface and the disk bottom.
  • the sealing surface of the sealing member is coated with an insulating coating; or the sealing surface of the sealing member is provided with an insulating film; or the sealing surface of the sealing member is A wire or a metal rod is formed, and the sealing member is sheathed with an insulating sleeve at least on the wire or the metal rod forming the sealing surface.
  • the ablation member comprises a metal annular skeleton having an annular outer wall surface, the annular outer wall surface being in contact with the inner wall of the left atrial appendage, the metal annular skeleton being electrically connected to a radio frequency source, and
  • the annular outer wall surface is an electrically conductive ablation surface.
  • the anchor comprises an anchoring body of a metal skeleton.
  • the outer side of the anchoring body is circumferentially spaced apart from a plurality of anchors.
  • the anchor is at least electrically conductive to the outer surface.
  • the anchor is fixedly coupled to the anchor by a steel sleeve; or the anchor is integrally formed with the anchor; or the anchor is directly fixed to the anchor On the order.
  • the anchoring body is a cylindrical structure, at least one of a distal end and a proximal end of the anchoring body is closed; or the distal end and the proximal end are both open, wherein The proximal end of the anchoring body is placed after the device is placed in the left atrial appendage, the anchoring body is adjacent to one end of the left atrium, and the distal end of the anchoring body is the device into which the left atrial appendage is placed Thereafter, the anchoring body is remote from one end of the left atrium.
  • the anchoring body is a folded structure, and the folding structure is formed by a center of the distal end of the ablation member extending away from the center, and is formed by gradually folding back.
  • the distal end of the ablation member is after the device is placed in the left atrial appendage, and the ablation member is away from one end of the left atrium.
  • the folded structure is gathered toward the center after folding to form a proximally closed anchoring body of the anchoring body; the folded structure is turned to the center after folding Extending to form a cuff region, forming an anchoring body of the proximal opening of the anchoring body; or the folding structure does not converge toward the center after folding, forming an anchoring of the proximal opening of the anchoring body a body; wherein the proximal end of the anchoring body is after the device is placed in the left atrial appendage, the anchoring body being adjacent one end of the left atrium.
  • 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; or at least the outer wall surface outside the metal mesh skeleton Providing an insulating film; or the metal mesh skeleton is made of a metal wire or a metal rod, and the metal mesh skeleton is at least in contact with or close to the inner wall surface of the left atrial appendage
  • the wire or the metal rod is covered with an insulating sleeve.
  • a barrier that closes the left atrial appendage is provided at least in the axial direction of the seal.
  • the barrier member is at least one flow-blocking film disposed at least axially inside the sealing member, the flow-blocking film being laterally disposed and fixed to the inner wall of the left atrial appendage; or the barrier a transversely sealed insulating film disposed at least at a proximal end and/or a distal end of the seal, the proximal end of the seal being the seal after the left atrial appendage ablation device is placed in the left atrial appendage
  • the member is adjacent to one end of the left atrium, and the distal end of the seal is an end of the seal away from the left atrium after the left atrial appendage ablation device is placed in the left atrial appendage.
  • the sealing member is provided with a connecting end, and the connecting end is electrically connected to the ablation member and the radio frequency source, respectively.
  • the connecting end is disposed at a center of a proximal end of the seal, and the connecting end is electrically connected to the ablation member through a metal mesh skeleton of the seal, wherein the seal
  • the proximal end of the piece is the end of the sealing member close to the left atrium after the left atrial appendage ablation device is placed in the left atrial appendage; or the transition piece is provided at the center of the sealing member, the transition piece
  • the connecting end is electrically connected to the ablation member.
  • the transition piece and the second connector are the same connector.
  • the left atrial appendage ablation device is provided with a sealing member, an ablation member and an anchoring member in sequence, and the sealing member is used for sealing the left atrial appendage to prevent the left atrial appendage from entering the left atrium; the ablation member ablation of the left atrial appendage to increase the atrial fibrillation ablation.
  • the success rate of healing; the anchor can stabilize the entire left atrial appendage ablation device in the left atrial appendage.
  • 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;
  • Figure 3 is a bottom view of Embodiment 1;
  • Figure 4 is a schematic view showing the structure of the flow blocking film of the embodiment 1 sewn in the sealing member
  • Figure 5 is a schematic view showing the structure of adding a layer of a flow blocking film in the ablation zone of Example 1;
  • FIG. 6 is a schematic view showing the release of the left atrial appendage ablation device to the left atrial appendage of Embodiment 1;
  • FIG. 7 is a schematic structural view of a left atrial appendage ablation device of Embodiment 2;
  • FIG. 8 is a schematic structural view of a left atrial appendage ablation device of Embodiment 3;
  • FIG. 9 is a schematic structural view of a left atrial appendage ablation device of Embodiment 4.
  • FIG. 10 is a schematic structural view of the distal end of the anchor of the left atrial appendage ablation device of Embodiment 4;
  • FIG. 11 is a schematic structural view of a left atrial appendage ablation device of Embodiment 5;
  • FIG. 12 is a schematic structural view of a left atrial appendage ablation device of Embodiment 6;
  • FIG. 13 is a schematic structural view of a left atrial appendage ablation device of Embodiment 7;
  • FIG. 14 is a schematic structural view of a left atrial appendage ablation device of Embodiment 8.
  • Figure 15 is a schematic view showing the release of the left atrial appendage ablation device to the left atrial appendage of Example 8;
  • FIG. 16 is a schematic structural view of a left atrial appendage ablation device of Embodiment 9;
  • FIG. 17 is a schematic structural view of a left atrial appendage ablation device of Embodiment 10.
  • FIG. 18 is a schematic structural view of a left atrial appendage ablation device of Embodiment 12;
  • FIG. 19 is a schematic structural view of a left atrial appendage ablation device of Embodiment 13.
  • Azimuth definition After the left atrial appendage ablation device is placed in the left atrium, the proximal end of each component of the device refers to the end near the position of the left atrium, and the distal end is the end away from the position of the left atrium.
  • the axial direction of the device refers to the direction in which the axis of the device is located, and the radial direction is a direction perpendicular to the central axis.
  • 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 1100 for closing the left atrial appendage at the proximal end of the device, an ablation member 1200 for annular ablation of the left atrial appendage, for The device is anchored to the anchor 1300 in the left atrial appendage.
  • the seal 1100 is provided with a sealing surface that is insulative and insulated from the inner wall of the left atrial appendage.
  • the ablation member 1200 is provided with a conductive ablation surface for adhering to the inner wall of the left atrial appendage, and the ablation surface is electrically connected to the radio frequency source.
  • the seal 1100 and the anchor member 1300 are insulated from the outer wall surface adjacent to or conforming to the inner wall of the left atrial appendage.
  • a barrier that closes the left atrial appendage is provided at least in the axial direction of the seal 1100.
  • the function of the seal 1100 is to block the left atrium and the left atrial appendage to prevent the thrombus in the left atrial appendage from entering the left atrium.
  • the ablation member 1200 ablates the inner wall of the left atrial appendage to increase the healing success rate of atrial fibrillation ablation.
  • the anchor 1300 can secure the entire left atrial appendage ablation device in the left atrial appendage.
  • the sealing member 1100 , the ablation member 1200 and the anchoring member 1300 are integrally formed; the integrated structure may be by welding or the like.
  • the structure directly fixed together may also be a unitary structure integrally formed.
  • the sealing member 1100 and the ablation member 1200 are integrally formed, and the ablation member 1200 and the anchor member 1300 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 1200 with the anchoring member 1300. Therefore, the structure of the connecting member 30 is not limited, and may be any shape according to the structure of the ablation member 1200 and the anchoring member 1300, 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 1200 and the anchor 1300.
  • the sealing member 1100 and the ablation member 1200 are connected by the connecting member 30 , and the ablation member 1200 and the anchoring member 1300 are integrally formed; the connecting structure in the embodiment is the same as the second embodiment. This will not be repeated here.
  • the structure of the connector connecting the seal 1100 and the ablation member 1200 may also be different from the structure of the connector connecting the ablation member 1200 and the anchor 1300. This application does not limit the specific structure of the connector.
  • 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. Since the three parts are connected differently, the shapes of the three are 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 1200, if between the ablation member 1200 and the sealing member 1100.
  • the connector 30 is provided to lengthen the distance therebetween, and the sealing position of the sealing member 1100 is located at a portion connecting the left atrial appendage and the left atrium, as shown in FIG.
  • the diameter of the sealing member 1100 is larger than the diameter of the ablation member 1200. If the ablation member 1200 is integrally formed with the seal 1100 and the sealing position of the seal 1100 is within the left atrial appendage, as shown in Figures 1, 5, 7-9 or 11-13, the seal 1100 has the same diameter as the ablation member 1200. . If the ablation member 1200 is integrally formed with the seal 1100, and the sealing position of the seal 1100 is at a portion connecting the left atrial appendage and the left atrium, as shown in FIG. 16, FIG. 17, or FIG. 18, the diameter of the seal 1100 is larger than the diameter of the ablation member 1200. Likewise, since the anchor 1300 is used for anchoring within the left atrial appendage, the anchoring body shape of the anchor 1300 is such that the anchor sting disposed on the anchoring body can penetrate into the left atrial appendage for anchoring.
  • the main body of the sealing member 1100 is a metal mesh skeleton 1110.
  • the metal mesh skeleton 1110 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 1100 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 metal mesh frame 1110 are set according to actual needs, and are not limited in the present invention.
  • the seal 1100 is a sealing disc formed by a metal mesh skeleton 1110, and the sealing disc is in conformity with a shape of a portion connecting the left atrial appendage and the left atrium; in this embodiment, the seal The member 1100 covers a portion connecting the left atrial appendage and the left atrium, the sealing member 1100 has a diameter slightly larger than the inner diameter of the left atrial appendage, and the sealing member 1100 adopts a disc-shaped structure having a short axial length, and the disc-shaped structure can directly press the connection. The left atrial appendage and the part of the left atrium.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug is consistent with the inner shape of the left atrial appendage.
  • the seal 1100 is inserted into the left atrial appendage, the diameter of the seal 1100 coincides with the inner diameter of the left atrial appendage, and the seal 1100 has a cylindrical configuration.
  • the seal 1100 is a sealed plug formed by a metal mesh skeleton 1110.
  • the sealing plug includes a disk surface facing away from the ablation member 1200, a disk bottom facing the ablation member 1200, and a waist portion connecting the disk surface to the disk bottom.
  • the disk surface of the sealing plug is in the shape of a disk
  • the bottom of the disk is in the shape of a cylinder or a truncated cone whose diameter is gradually reduced.
  • 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 covering the left atrial appendage and the left atrial portion is slightly larger than the inner diameter of the left atrial appendage, and the diameter of the cylindrical or truncated portion in the left atrial appendage is the same as the inner diameter of the left atrial appendage.
  • the main structure of the sealing member 1100 is a metal mesh skeleton 1110. Therefore, the blocking member 1100 is a radially disposed blocking member, and the blocking member disposed on the sealing member 1100 can be in two different ways: It is disposed inside the seal 1100, and is disposed at the proximal end and/or the distal end of the seal 1100.
  • a choke film can be used internally, and a baffle or/and an insulating film can be used at the proximal or/and distal end.
  • the seal 1100 functions as a seal which does not allow ablation, so the seal 1100, and in particular the portion of the seal 1100 that is attached to the left atrial appendage, is insulated.
  • the insulation treatment can improve the ablation impedance of the whole left atrial appendage ablation device, reduce the conductive contact surface area of the left atrial appendage ablation device and blood and tissue, and avoid excessive energy loss in the blood or non-target tissue, thereby concentrating
  • the energy is used for tissue ablation of the tissue at the target point of the ablation member 1200, while reducing damage to the tissue of the non-ablative region during the ablation process.
  • the following different implementations are available depending on the insulation method:
  • the first embodiment of the sealing member 1100 is insulated: the metal mesh frame 1110 of the sealing member 1100 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 sealing member 1100 that is attached to the left atrial appendage. Wall. At least the sealing surface is coated with an insulating coating, which means that at least the outer peripheral wall of the sealing member 1100 is coated with an insulating coating, and the insulating coating is formed by coating on the metal mesh skeleton 1110 by using an insulating material. The insulating material of the layer, the isolated metal mesh skeleton 1110 is in conductive contact with the left atrial appendage.
  • the second embodiment of the sealing member 1100 is insulated: the metal mesh frame 1110 is provided with an insulating film 2120 at least at the sealing surface; the insulating film 2120 can be fixed to the metal mesh frame 1110 by stitching, hot pressing, spraying, dipping or the like.
  • the outer surface forms a sealing surface, or the inner and outer surfaces of the metal mesh frame 1110 simultaneously fix the insulating film 2120.
  • the insulating film 2120 may be made of FEP, ETFE, PFA, PTFE or silica gel material.
  • the metal mesh skeleton 1110 is made of a wire or a metal rod, and an insulating sleeve is sheathed at least on the wire or metal rod forming the sealing surface.
  • the insulating sleeve is made of FEP, ETFE, PFA, PTFE and other materials.
  • the metal mesh frame 1110 is insulated from the inner wall of the left atrial appendage by being worn outside the wire or metal rod.
  • the ablation member 1200 since the ablation member 1200 performs annular ablation on the inner wall of the left atrial appendage, the ablation member 1200 includes a metal annular skeleton that is attached to the inner wall of the left atrial appendage, and the metal annular skeleton is electrically connected to the radio frequency source, and the annular outer wall surface of the metal annular skeleton is The electrically conductive ablation surface, the annular outer wall surface and the inner wall of the left atrial appendage.
  • the metal ring-shaped skeleton is annular, and may be a mesh shape in which the wires are woven, or a fence shape in which metal rods are arranged in parallel with each other, or a plurality of structures capable of radially contracting and stretching, such as a spiral shape. .
  • the anchor 1300 includes an anchoring body of the metal mesh skeleton 1110.
  • the outer side of the anchoring body is circumferentially spaced apart from the plurality of anchor thorns, and the anchor thorn extends toward the proximal outer side.
  • a first embodiment of the anchor 1300 is that the anchor body is a cylindrical structure, and the anchor is uniformly disposed circumferentially on the outer wall of the cylindrical structure. At least one of the distal end and the proximal end of the anchoring body of the cylindrical structure is closed; or the distal end and the proximal end of the anchoring member 1300 of the cylindrical structure are open.
  • a second embodiment of the anchoring member 1300 is: the anchoring body is a folded structure, and the folding structure is extended from the center of the distal end of the ablation member 1200 toward the center, and is gradually folded in reverse, and the anchor is turned over.
  • the outer wall of the folded structure is uniformly arranged in the circumferential direction.
  • the folded structure is gathered toward the center after folding to form a proximally closed or approximately closed anchoring body; or the folded structure extends to the center after folding to form a cuffing region, forming an anchoring body with a proximal opening; or folding The structure does not converge toward the center after folding, forming an anchoring body with a proximal opening.
  • the metal mesh skeleton 1110 of the anchor body of the anchor 1300 is coated with an insulating coating at least on the outer wall surface that is attached to the left atrial appendage; or the metal mesh skeleton 1110
  • the insulating film 2120 is provided at least at the outer wall surface; or the metal mesh frame 1110 is made of a metal wire or a metal rod, at least on a wire or a metal rod attached to the inner wall surface of the left atrial appendage or close to the inner wall surface of the left atrial appendage.
  • the insulating structure of the above embodiment is the same as the sealing member 1100, and details are not described herein again.
  • the anchoring member 1300 is provided with a plurality of anchor thorns 1330 for anchoring on the inner wall of the left atrial appendage.
  • the anchor thorns 1330 are disposed on the outer wall surface of the anchoring body 1310, and are uniformly disposed along the circumferential direction of the outer wall surface of the anchoring body 1310, according to
  • the anchor thorn 1330 is set in different ways, and has the following implementation modes:
  • the first embodiment of the anchor thorn 1330 is connected to the anchor 1300: the anchor thorn 1330 can be directly fixed on the anchoring body 1310 in a fixed manner by welding or the like;
  • a second embodiment in which the anchor 1330 is coupled to the anchor 1300 the anchor 1330 can also be fixedly coupled to the anchor 1300 by a steel sleeve.
  • a third embodiment in which the anchor 1330 is coupled to the anchor 1300 is that the anchor 1330 is integrally formed with the anchor 1300, that is, the anchor 1330 is formed by the anchor 1300 extending directly.
  • the anchor thorn 1330 is arranged in a number of 6-9, the anchor thorn 1330 opening angle is between 30° and 60°, the direction is toward the proximal end, and the anchor thorn 1330 is between 0.5 and 4 mm in length.
  • the anchor stud 1330 is at least electrically conductive to the outer surface and is electrically coupled to the radio frequency source to ablate the anchor puncture 1330 and the left atrial appendage contact location.
  • the ablation member 1200 and the anchor 1300 in addition to providing at least one baffle film 1120 for blocking thrombus inside the seal 1100, it is also possible to simultaneously ablate the member 1200 or/and the anchor.
  • the flow blocking film 1220 and the flow blocking film 1320 are disposed in the fixing member 1300, and the periphery of the blocking film 1120, 1220, 1320 is fixed in the interior thereof by a plurality of stitching points, and the blocking film 1120, 1220, 1320 may be PET or PTFE film.
  • the number and position of the baffles 1120, 1220, 1320 are set to 1-5 depending on actual needs.
  • the sealing member 1100 and the surface of the anchoring member 1300 are treated with an insulating coating and a suture blocking membrane 1120.
  • 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 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 1200, and
  • the ablation process is reduced to the damage of the tissue in the non-ablative region;
  • the ablation member 1200 is a bare dense annular mesh wire structure adapted to the left atrial appendage structure and closely attached to the targeted ablation region to realize the left atrial appendage
  • the inner wall is densely ablated and multi-point ablation, which greatly improves the success rate of ablation and shortens the operation time.
  • the same anchor 1300 of the anchor 1300 is made of metal material, which is mainly used to strengthen and stabilize the structure of the left atrial appendage ablation device in the left atrial appendage.
  • the position can also be used for ablation, and the ablation member 1200 achieves a dual ablation function.
  • connection end may be provided on the sealing member 1100, and the connection end is electrically connected to the ablation member 1200 and the RF source, respectively.
  • the connection end is a tip structure formed by the convergence of the wires of the sealing member 1100, and may be additionally fixed to the structure on the end surface of the sealing member 1100.
  • the connecting end is disposed at the center of the proximal end of the sealing member 1100, and the connecting end is electrically connected to the ablation member 1200 in three ways: the first type is that the connecting end is electrically connected to the ablation member 1200 through the metal mesh skeleton 1110 of the sealing member 1100;
  • the seal member 1100 is provided with a transition piece 30 at the center, the transition piece 30 electrically connects the connection end and the ablation member 1200; and the third type is the metal ring frame of the ablation member 1200 is directly electrically connected to the radio frequency source through the wire.
  • the left atrial appendage ablation device 1000 is constructed of three parts: a seal 1100, an ablation member 1200, and an anchor 1300.
  • the sealing member 1100 is located in the proximal end region, and further comprises a metal mesh frame 1110, one or more layers of the flow blocking film 1120 and the connecting end 1130; the connecting end 1130 is located at the center of the proximal end surface 1140, and the bolt head is preferably used.
  • the connector 1130 is coupled to a delivery lead that transmits radio frequency energy from the RF source to the ablation device 1200.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are integrally formed, that is, the metal mesh skeleton 1110 of the sealing member 1100, the metal annular skeleton 1210 of the ablation member 1200, and the anchoring member 1300 are anchored.
  • the main body 1310 is a unitary structure, and the sealing member 1100, the ablation member 1200 and the anchoring member 1300 have the same diameter, and the overall device exhibits a round plug structure.
  • the wire is woven into a sealing member 1100, and the ablation member 1200 and the anchoring member 1300 are integrally formed into three parts, and then formed.
  • the connecting end 1130 disposed on the sealing member 1100 is converged on the metal of the proximal end surface 1140.
  • the head end of the skeleton; the head 1340 converges the distal end face 1311 of the anchor 1300 to the metal skeleton head end, 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 1100, the ablation member 1200 and the anchoring member 1300 may also be a structure directly fixed together by welding or the like.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110.
  • the sealing plug is matched with the inner shape of the left atrial appendage; in this embodiment, the sealing member 1100 is inserted into the left atrial appendage, and the diameter of the sealing member 1100 is consistent with the inner diameter of the left atrial appendage.
  • the seal 1100 has a cylindrical structure.
  • the metal mesh skeleton 1110 of the sealing member 1100 of the present embodiment 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 metal mesh skeleton 1110 by coating with an insulating material.
  • One or more layers of insulating material, the insulating metal mesh skeleton 1110 is in contact with the left atrial appendage; the insulation of the sealing member 1100 can also be applied to each of the metal wires or metal rods of the metal mesh skeleton 1110.
  • the sealing of the seal 1100 is achieved by a flow blocking film 1120 disposed inside thereof.
  • the periphery of the baffle film 1120 is fixed to the inside of the metal mesh frame 1110 by a stitching method, such as a PET or PTFE film.
  • the ablation member 1200 is located in the middle of the three regions, and the ablation member 1200 includes a metal annular skeleton 1210 that is attached to the inner wall of the left atrial appendage for a week.
  • the metal annular skeleton 1210 is a main structure of the ablation member 1200, and the wire is woven to form a grid intersecting each other.
  • the metal annular skeleton is electrically connected to the radio frequency source, and the annular outer wall surface of the metal annular skeleton is an electrically conductive ablation surface.
  • the axial length of the metal ring skeleton 1210 is between 1 and 12 mm, preferably 5 mm in this embodiment, and the surface of the metal ring skeleton 1210 is not insulated and is a bare metal structure.
  • the anchor 1300 is located at the distal end of the device and includes an anchoring body 1310, a baffle 1320, an anchor 1330, and a head 1340; the anchoring body 1310 is a cylindrical structure.
  • the anchor body 1310 of the anchor 1300 is provided with a plurality of anchor thorns 1330 for anchoring on the inner wall of the left atrial appendage 1300, and the anchor thorns 1330 are uniformly disposed circumferentially on the outer wall of the cylindrical structure.
  • the distal end of the anchoring body 1310 of the cylindrical structure is closed and the proximal end is integrated with the ablation member 1200.
  • the metal mesh skeleton 1110 of the anchoring body 1310 is coated with an insulating coating at least on the outer wall surface that is attached to the left atrial appendage; in this embodiment, the surface of the anchoring body 1310 is covered with an insulating coating, and the coating may be coated.
  • the method is fixed on the metal skeleton of the anchor body 1310, and an insulating sleeve such as a FEP/ETFE/PFA/PTFE sleeve can be used, and the insulating sleeve is set outside each metal wire or metal rod;
  • the membrane 1320 and the periphery of the baffle film 1320 are fixed to the inside of the anchor body 1310 by a suture, such as a PET or PTFE film.
  • the anchor thorn 1330 and the anchoring body 1310 are an integral structure or a fixed connection structure.
  • the anchor rib 1330 is connected to the anchoring body 1310 by using a steel sleeve 1350, and the position is at the distal end of the anchoring member 1300, and the number is 6-
  • the anchor thorn 1330 opening angle is between 30 ° ⁇ 60 °, the direction is toward the proximal end
  • the anchor thorn 1330 is between 0.5 ⁇ 4 mm in length
  • the head 1340 is located at the center of the distal end surface 1311 of the anchor 1300.
  • the periphery of the baffle film 1120 is fixed to the inside of the metal mesh frame 1110 by a plurality of stitching points 1121 by a stitching method, and the choke film 1120 may be a PET or PTFE film.
  • one or more layers of the flow blocking film 1220 may also be disposed in the ablation member 1200.
  • Fig. 6 shows the state in which the left atrial appendage ablation device 1000 is released in the left atrial appendage of the present embodiment.
  • the connecting end 1130 of the sealing member 1100 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 1300 is released inside the left atrial appendage 7 after release, and the anchor puncture 1330 is hooked into the left.
  • the inner wall of the auricle 7; the ablation member 1200 is closely attached to the inner wall of the left atrial appendage 7, and the obstruction membrane in the sealing member 1100 blocks the left atrial appendage 7 to prevent blood flow from entering the left atrial appendage 7 and the left atrial appendage 7 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 1130 of the ablation device 1000 is blocked, and the connection end 1130 receives the radiofrequency ablation energy and transmits the ablation device 1200 to the ablation device 1200.
  • the ablation device 1200 adopts a mesh weaving method, and the mesh is dense, so that the left side can be realized. Ablation of all targets in the circumferential direction of the inner wall of the auricle 7 is blocked.
  • the delivery lead 2 and the left atrial appendage ablation device 1000 are released, and the left atrial appendage ablation device 1000 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 1000 in one operation, and realize the complete ablation of the left atrial appendage, thereby increasing the ablation success rate of the atrial fibrillation.
  • the left atrial appendage ablation device 1000 of the present embodiment is also composed of three parts: a seal 1100, an ablation member 1200, and an anchor 1300.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are integrally formed.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the anchoring body 1310 has a cylindrical structure, the distal end of the cylindrical structure is closed, and the proximal end is integrally connected with the ablation member 1200.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 have the same structure as the first embodiment.
  • the main difference is that the sealing member 1100 is sealed with an insulating film 2120.
  • the insulating film 2120 can be stitched and heated.
  • the insulating film 2120 is fixed on the outer surface of the metal mesh frame 1110 or the inner and outer surfaces of the metal mesh frame 1110 by pressing, spraying, dipping, etc., and the insulating film 2120 may be an insulating film 2120 such as FEP, ETFE, PFA, PTFE or silica gel.
  • the surface of the anchoring body 1310 of the anchoring zone is also provided with an insulating film 2320 in the same manner as the sealing zone insulating film 2120.
  • the surface of the insulating film of the embodiment has a dense structure and is non-porous, and can achieve effective insulation.
  • the insulating film 2120 is also disposed at the proximal end of the sealing member 1100, and the insulating film 2120 is disposed as a barrier member to block the thrombus.
  • the blocking film in the sealing member 1100 may or may not be provided.
  • Embodiment 1 the difference from Embodiment 1 is that the position of the anchor 1330 is relatively close to the proximal end of the anchor 1300.
  • the left atrial appendage ablation ablation device 1000 of the embodiment 3 of the present invention is composed of three parts: a sealing member 1100, an ablation member 1200, and an anchor member 1300.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are integrally formed.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the anchoring body is a cylindrical structure, the distal end of the cylindrical structure is closed, and the proximal end is integrally connected with the ablation member 1200.
  • 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 ablation member 1200 is composed of a bare metal rod 1210, and the metal rods are arranged at intervals in the axial direction to form a ring shape, and the metal mesh frame of the sealing member 1100 is formed.
  • each of the two braided wires are joined together to form a metal rod 3210, and the metal rod 1210 has an axial length of 1-12 mm, preferably 5 mm in this example; then the metal rods 1210 are separated by two braided wires to form an anchor region mesh.
  • Metal skeleton 1310. The rest of the structure is the same as in Embodiments 1 and 2. I will not repeat them here.
  • the left atrial appendage ablation device 1000 of the fourth embodiment of the present invention is also composed of three parts: a sealing member 1100, an ablation member 1200, and an anchor member 1300. Three-part integrated structure.
  • the sealing member, the ablation member 1200 and the anchor member 1300 are integrally formed.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the anchor body is a cylindrical structure.
  • the anchor 1330 and the anchor body 1310 are integrally connected or fixedly connected, and the anchor 1330 can be fixed to the anchor body 1310 by the steel sleeve 1350, or directly fixed to the anchor body 1310.
  • the position and effect of the joint end 1130 of the seal 1100 are the same as in the first embodiment, and the metal mesh skeleton 1110 of the seal 1100 and the anchor body 1310 of the anchor 1300 can be insulated in the same manner as in the embodiment 1-3.
  • the difference between the embodiment and the embodiment 1-3 is that the distal abutment surface 1311 of the left atrial appendage occluder ablation device 1000 is an open structure, that is, the anchor body is a circle.
  • the cylindrical structure, the distal end of the anchor 1300 is open, without a head.
  • the fifth left atrial appendage ablation device 1000 of the present invention is composed of three parts: a sealing member 1100, an ablation member 1200, and an anchor member 1300.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are integrally formed.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the structure is the same as in Example 1-2. I will not repeat them here.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are all formed by laser cutting heat setting, and the wave structure thereof may be the same or different; the sealing member 1100, the ablation member 1200 of the left atrial appendage occlusion ablation device of the present invention and The outer surface of the anchor 1300 can also be tapered or spherical.
  • the left atrial appendage ablation device 1000 of the embodiment of the present invention is composed of three parts: a sealing member 1100, an ablation member 1200 and an anchor member 1300, a sealing member 1100, an ablation member 1200 and an anchor member 1300.
  • a sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the anchor body is a cylindrical structure.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are all formed by laser cutting heat setting, and the waveform structures thereof may be the same or different.
  • the ablation member 1200 is located in the middle portion, and is circumferentially arranged by the bare metal rod 1210 to form a ring shape, which is electrically conductive.
  • the rest of the structure is the same as in Example 1-2. I will not repeat them here.
  • the left atrial appendage ablation device 1000 of the present invention is composed of three parts: a seal 1100, an ablation member 1200, and an anchor 1300.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are integrally formed.
  • the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, and the sealing plug conforms to the inner shape of the left atrial appendage.
  • the sealing member 1100, the ablation member 1200 and the anchoring member 1300 are all formed by laser cutting heat setting, wherein the sealing member 1100 is located at a proximal end position, further comprising a metal mesh skeleton 1110 and a connecting end 1130 formed by cutting; the connecting end 1130
  • the position and effect are the same as in the first embodiment.
  • the ablation member 1200 is located in the middle portion, and is composed of a bare metal ring-shaped bone 1210, and is electrically conductive;
  • the anchoring member 1300 is located at the distal end, and includes an anchoring body 1310 formed by cutting, and an anchor thorn 1330 is disposed on the outer wall surface of the anchoring body, and the anchor thorn is provided.
  • 1330 and the anchor body 1310 are of a unitary structure, and the sealing treatment of the seal 1100 and the anchor 1300 can be the same as that of the embodiment 1 or 2.
  • the difference between the embodiment and the above embodiment is that the distal abutment surface 1311 of the left atrial appendage occluder ablation device 1000 is an open structure, that is, the anchor body is a cylindrical structure.
  • the distal end of the anchor 1300 is open without a head.
  • the outer surface of the left atrial appendage ablation device 1000 can also be tapered or spherical. That is, the distal end of the anchor 1300 is gradually inwardly contracted to form a distal opening having a diameter smaller than the diameter of the anchor 1300.
  • the left atrial appendage ablation device 1000 of the present embodiment 8 includes a seal 1100, an ablation member 1200, and an anchor 1300.
  • the seal 1100 is coupled to the ablation member 1200 by a connector 30, and the ablation member 1200 and the anchor member 1300 are integrally formed. That is, the left atrial appendage plugging ablation device
  • the overall metal skeleton is a double disc structure, including a near disc and a far disc. The near disc and the far disc are connected by a connecting member 30.
  • the near disc is formed by heat-setting a nickel-titanium wire braid to form a sealing member 1100; the distal disc includes an ablation member 1200 and an anchoring member 1300, and is also formed by nickel-titanium weaving.
  • the sealing member 1100 is a sealing disk formed by the metal mesh skeleton 1110, and the sealing disk is matched with the shape of the portion connecting the left atrial appendage and the left atrium.
  • the sealing member 1100 covers a portion connecting the left atrial appendage and the left atrium, the sealing member 1100 has a diameter slightly larger than the inner diameter of the left atrial appendage, and the sealing member 1100 adopts a disc-shaped structure having a short axial length, a disk shape. The structure can directly cover the part connecting the left atrial appendage and the left atrium.
  • the main body of the sealing member 1100 is a metal mesh skeleton 1110.
  • One or more layers of the flow blocking film 1120 are disposed in the metal mesh frame 1110.
  • the end surface of the sealing member 1100 is provided with a connecting end 1130.
  • the surface of the metal mesh frame 1110 is insulated.
  • the coating technique is applied to the first embodiment.
  • the coating may be applied to the metal mesh frame 1110 by coating, or may be an insulating sleeve, for example, FEP, ETFE, PFA, or PTFE. Insulating sleeve; at the same time, a polymer blocking film is coated on the inner surface or the outer surface of the sealing member 1100, preferably a PET or PTFE film.
  • the connection end 1130 is located at the center of the proximal end 10, such as a bolt head, for connecting the delivery wires and receiving radio frequency ablation energy.
  • the ablation member 1200 is located at the proximal end of the far disk and is an annular mesh metal skeleton 1210 having an axial length of 5 mm.
  • the difference from the metal mesh skeleton 1110 of the sealing member 1100 is that the surface thereof has no insulating coating or insulating sleeve. Exposed metal structure that conducts electricity.
  • the anchor 1300 is located at the distal end of the distal disc and includes an anchoring body 1310, a baffle film 1320, an anchor thorn 1330, and a head 1340.
  • the surface of the anchoring body 1310 is provided with an insulating coating.
  • the coating may be fixed on the metal skeleton of the anchoring body 1310 by coating, and an insulating sleeve may also be used; the periphery of the blocking film 1320 is fixed to the anchoring body by stitching.
  • Inside the 1310 such as PET or PTFE film.
  • the anchor thorn 1330 and the anchoring body 1310 are integrated or connected.
  • the anchor rib 1330 is connected with the anchoring body 1310 by using a steel sleeve 1350.
  • the anchor thorn 1330 is located at the distal end of the anchor 1300, and the number is 6. -9, the anchoring angle is between 30° and 60°, the direction is toward the proximal end, the anchoring length is between 0.5 and 4 mm, and the head 1340 is located at the center of the distal end surface 1311.
  • the anchor thorn 1330 is electrically conductive at least on the outer surface and electrically connected to the radio frequency source to ablate the anchor thorn 1330 and the left atrial appendage contact position.
  • the anchor thorn 1330 is made of a conductive metal material, and the surface is not insulated.
  • the sealing member 1100 or the anchoring member 1300 of the left atrial appendage ablation device of the present embodiment can also adopt the insulation treatment method described in Embodiment 2, that is, the outer surface of the sealing member 1100 or the anchoring member 1300, or the inner and outer surfaces are simultaneously fixed and insulated.
  • the membrane, the insulating film disposed at the proximal end or/and the distal end of the sealing member 1100, and the insulating film disposed at the distal end of the anchoring member 1300 as a barrier member can function to block the thrombus.
  • the metal mesh skeleton 1110 of the sealing member 1100 and the metal annular frame 1210 of the ablation member 1200 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 1200 and the center of the end face of the distal end of the sealing member 1100.
  • the metal skeleton of the ablation zone of the left atrial appendage ablation device of this embodiment can also be similar to that of the embodiment 3, and is provided as a metal rod structure.
  • each part of the left atrial appendage ablation device of this embodiment is the same as that of the first embodiment.
  • the disc-shaped structure sealing member 1100 can directly cover the portion connecting the left atrial appendage and the left atrium, improving the sealing effect and reducing the residual shunt. As shown in FIG.
  • the left atrial appendage ablation device 1000 is released to the shape of the left atrial appendage 7 before the insulated steel cable is released, and the anchoring member 1300 is anchored in the left atrial appendage 7, the ablation member 1200 and the left The auricle 7 is closely attached; the seal 1100 blocks the left atrial appendage 7 to prevent blood flow into the left atrial appendage 7 and 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 1130 of the left atrial appendage ablation device 1000 through the steel cable, and the terminal 1130 receives the radio frequency ablation energy transfer. Give the ablation zone to achieve ablation surgery.
  • the left atrial appendage ablation device 1000 of the present embodiment includes a seal 1100, an ablation member 1200, and an anchor 1300.
  • the sealing member 1100 and the ablation member 1200 are integrally formed, the ablation member 1200 and the anchoring member 1300 are connected by the connecting member 30; the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110, or the sealing member 1100 is a metal mesh skeleton. Sealing disk formed by 1110. The sealing member is pressed against the portion connecting the left atrial appendage and the left atrium.
  • the sealing member 1100 has a diameter slightly larger than the inner diameter of the left atrial appendage, and the sealing member 1100 adopts a disc-shaped structure having a short axial length, and the disc-shaped structure can directly press the connection.
  • the left atrial appendage ablation device is a double disc structure, including a near disc and a far disc.
  • the near disc and the far disc are connected by a connecting member 30.
  • the near disc includes a sealing member 1100 and an ablation member 1200; the distal disc is an anchor member 1300; and the near disc and the far disc are both formed by heat-setting a nickel-titanium wire braid.
  • the sealing member 1100 is integrally formed with the ablation member 1200 to form a cork shape.
  • the diameter of the sealing member 1100 is larger than the diameter of the ablation member 1200.
  • the diameter of the ablation member 1200 is gradually reduced from the proximal end to the distal end to form a truncated cone shape.
  • the ablation member 1200 is located at the distal end of the near disk, and includes a metal annular frame 1210.
  • the metal amalgam frame 1110 of the sealing member 1100 is different from the metal mesh frame 1110 of the sealing member 1100 in that it has no insulating coating or insulating sleeve on the surface, and is a bare metal structure and is electrically conductive.
  • One or more layers of the flow blocking film 1220 may be disposed inside the ablation member 1200.
  • the anchor 1300 is located at the distal end of the distal disc and includes an anchoring body 1310, one or more layers of the baffle 1320, an anchor 1330, and a head 1340.
  • 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 1000 of the present embodiment includes a sealing member 1100, an ablation member 1200, and an anchor member 1300.
  • the sealing member 1100 and the ablation member 1200 are integrally formed, and the ablation member 1200 and the anchor member 1300 are connected by a connecting member 30; the sealing member 1100 is a sealing plug formed by the metal mesh skeleton 1110.
  • the seal may also be a sealing disk that is integral with the ablation member 1200.
  • the structure of the sealing member 1100 and the ablation member 1200 is the same as that of Embodiment 9, and details are not described herein again.
  • the ablation member 1200 is located at the distal end of the near disc, and includes a metal annular skeleton 1210.
  • the metal annular skeleton 1210 is a bare metal structure and is electrically conductive.
  • One or more layers of the flow blocking film 1220 may be disposed inside the ablation member 1200.
  • the anchoring body is a folded structure, and the folding structure is formed by extending from the center of the distal end of the ablation member 1200 away from the center, and is gradually folded in reverse.
  • the anchor thorn is evenly arranged in the circumferential direction of the outer wall of the folded structure.
  • the specific structure is that the anchor 1300 is a laser-cut distal opening structure, and the connecting portion 30 at the distal end of the ablation member 1200 extends away from the center to form an inner supporting segment, and then reversely folds to form an anchor. 1300.
  • 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 1200, and the proximal end of the anchor 1300 is spaced from the diameter of the ablation member 1200.
  • 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 of the folded structure is a single layer structure when compressed in the sheath tube, which can reduce the diameter of the sheath tube.
  • the left atrial appendage ablation device 1100 of the present embodiment 11 includes a seal 1100, an ablation member 1200, and an anchor 1300.
  • the main structure of the embodiment is the same as that of the embodiment 10, and details are not described herein again.
  • the overall metal skeleton of the left atrial appendage ablation device is a double disc structure, including a proximal disc, a distal disc, and a connecting member 30 therebetween.
  • the near disc is a seal 1100; the distal disc includes an ablation member 1200 and an anchor 1300.
  • the sealing member 1100 is located at the proximal end, and further comprises a metal mesh frame 1110, one or more layers of the flow blocking film 1120 and the connecting end 1130; the metal mesh frame 1110 is surface-insulated, and the embodiment is coated with the first embodiment. Technology will not be described here.
  • the embodiment has the same structural shape as that of the embodiment 10.
  • the difference from the embodiment 10 is that the ablation member 1200 is a laser-cut metal ring skeleton 1210, and the metal ring skeleton 1210 is a bare metal structure and is electrically conductive.
  • the left atrial appendage ablation device 1000 of the present embodiment includes a seal 1100, an ablation member 1200, and an anchor 1300.
  • the basic structure is the same as that of the embodiment 10.
  • the anchoring member 1300 is a folded structure that is convergently closed to the center after folding, forming a proximally closed or approximately closed anchoring body; the anchoring member 1300 is entirely woven by a braided wire to form a mesh. Structure.
  • the left atrial appendage ablation device 1000 of the present embodiment includes a seal member 1100, an ablation member 1200, and an anchor member 1300.
  • the skeleton structure of the left atrial appendage ablation device of the present embodiment has a three-disc structure including a proximal disc, an intermediate disc, a distal disc and a connecting member 30 therebetween. That is, between the sealing member 1100 and the ablation member 1200, and between the ablation member 1200 and the anchor member 1300 are respectively connected by the connecting member 30.
  • the near disk is a sealing member 1100, which is formed by using nickel-titanium wire braiding heat setting, and includes a metal mesh skeleton 1110, one or more layers of the flow-blocking film 1120 and a connecting end 1130; and a metal mesh skeleton 1110 surface insulating treatment method and The position of the connection end is as shown in Embodiment 1 or Embodiment 2.
  • the intermediate disk is an ablation member 1200, which is formed by heat-setting a nickel-titanium wire braid, and includes a metal ring skeleton 1210.
  • the metal ring-shaped frame 1210 is a bare metal structure and is electrically conductive.
  • the distal disc is an anchoring member 1300, which is woven from nickel-titanium wire and comprises an anchoring body 1300, one or more layers of a flow-blocking membrane 1320, an anchoring structure 1330 and a head 1340.
  • the arrangement of the anchor body 1300 and the head 1340 and the flow blocking film 1320 is the same as that of the eighth embodiment.
  • the anchor 1330 is connected in the same manner as in the first embodiment, and is fixed to the wire by a steel sleeve 1350.
  • the metal mesh skeleton 1110 of the near-disk seal 1100 and the metal ring skeleton 1210 of the intermediate disk ablation member 1200 and the metal ring skeleton 1210 of the ablation member of the intermediate disk and the anchor body 1310 of the remote disk anchor are connected by the connector 30. Together, they can be joined together by welding or pressing.
  • the connectors 30 are all columnar structures disposed at the center of the seal 1100, the ablation member 1200, and the anchor 1300, respectively.

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Abstract

La présente invention concerne un appareil d'occlusion et d'ablation d'appendice auriculaire gauche, comprenant un joint d'étanchéité (1100) situé à l'extrémité proximale de l'appareil et utilisé pour fermer l'appendice auriculaire gauche, et un ancrage (1300) situé à l'extrémité distale de l'appareil et utilisé pour ancrer l'appareil dans l'appendice auriculaire gauche. L'appareil comprend en outre un élément d'ablation (1200) utilisé pour l'ablation annulaire de la paroi interne de l'appendice auriculaire gauche. L'appareil d'occlusion et d'ablation de l'appendice auriculaire gauche peut réaliser l'ablation de la fibrillation auriculaire et la prévention des accidents vasculaires cérébraux.
PCT/CN2018/090854 2017-06-16 2018-06-12 Appareil d'occlusion et d'ablation d'appendice auriculaire gauche WO2018228383A1 (fr)

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CN201720707136.5 2017-06-16
CN201710510388.3A CN109124755A (zh) 2017-06-16 2017-06-28 左心耳封堵消融装置
CN201710510388.3 2017-06-28

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WO2022076258A1 (fr) * 2020-10-05 2022-04-14 Fishel Robert S Mécanisme et dispositif d'occlusion de l'appendice auriculaire gauche avec isolation électrique
US11357512B2 (en) 2017-05-12 2022-06-14 Robert Fishel Mechanism and device for left atrial appendage occlusion with electrical isolation

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WO2016202708A1 (fr) * 2015-06-19 2016-12-22 Koninklijke Philips N.V. Dispositif médical implantable et système de chauffage de tissu
CN106175867A (zh) * 2016-08-30 2016-12-07 上海心玮医疗科技有限公司 一种左心耳封堵器及其制备方法
CN106466196A (zh) * 2016-09-22 2017-03-01 杭州诺茂医疗科技有限公司 一种分体式左心耳封堵器

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11357512B2 (en) 2017-05-12 2022-06-14 Robert Fishel Mechanism and device for left atrial appendage occlusion with electrical isolation
WO2022076258A1 (fr) * 2020-10-05 2022-04-14 Fishel Robert S Mécanisme et dispositif d'occlusion de l'appendice auriculaire gauche avec isolation électrique
GB2614204A (en) * 2020-10-05 2023-06-28 S Fishel Robert Mechanism and device for left atrial appendage occlusion with electrical isolation

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