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WO2022135424A1 - Dispositif d'ablation d'appendice auriculaire gauche et procédé de commande - Google Patents

Dispositif d'ablation d'appendice auriculaire gauche et procédé de commande Download PDF

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Publication number
WO2022135424A1
WO2022135424A1 PCT/CN2021/140235 CN2021140235W WO2022135424A1 WO 2022135424 A1 WO2022135424 A1 WO 2022135424A1 CN 2021140235 W CN2021140235 W CN 2021140235W WO 2022135424 A1 WO2022135424 A1 WO 2022135424A1
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WIPO (PCT)
Prior art keywords
occluder
left atrial
atrial appendage
ablation
conductive
Prior art date
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Ceased
Application number
PCT/CN2021/140235
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English (en)
Chinese (zh)
Inventor
王永胜
尤岩
丘家明
陈杰
刘成
王坤
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Dinova EP Technology Co Ltd
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Hangzhou Dinova EP Technology Co Ltd
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Publication of WO2022135424A1 publication Critical patent/WO2022135424A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • 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
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12159—Solid plugs; being solid before insertion
    • 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
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG

Definitions

  • the invention relates to the field of medical devices, in particular to a left atrial appendage ablation device and a control method.
  • Atrial fibrillation is the most common sustained cardiac arrhythmia, and the incidence of atrial fibrillation increases with age. Some data show that the incidence of atrial fibrillation in people over the age of 75 can reach 10%. In addition, the prevalence of atrial fibrillation is also closely related to coronary heart disease, hypertension and heart failure.
  • the left atrial appendage is not only the most important part of atrial fibrillation thrombosis due to its special shape and structure, but also one of the key areas for its occurrence and maintenance. Some patients with atrial fibrillation can benefit from active left atrial appendage electrical isolation surgery. .
  • Radiofrequency ablation + left atrial appendage closure is one of the hot spots in the treatment of atrial fibrillation today.
  • many cases of successful treatment of atrial fibrillation have been achieved using the one-stop treatment method of combined catheter radiofrequency ablation and left atrial appendage occlusion.
  • the one-stop treatment method through left atrial appendage occlusion, patients can still obtain good stroke prevention effect without lifelong anticoagulant medication; combined with catheter radiofrequency ablation to restore and maintain sinus rhythm to improve atrial fibrillation The patient's symptoms can enable the patient to obtain a stable long-term treatment effect.
  • the present invention provides a left atrial appendage ablation device and a control method for the problem that the existing medical equipment involved in surgical treatment of the left atrial appendage is not conducive to realizing one-stop treatment of ablation function and blocking function.
  • the present invention provides a left atrial appendage ablation device, comprising:
  • An occluder for placing at the opening of the left atrial appendage is provided with a first conductive part, and the first conductive part is used to transmit the first ablation energy to the tissue;
  • a conveyor for delivering the occluder includes a bracket that can move relative to the occluder, the bracket is provided with a second conductive part, and the second conductive part is used for providing tissue to the tissue
  • a second ablation energy is transmitted and/or an intracardiac electrophysiological signal is acquired, the first ablation energy and the second ablation energy having opposite polarities.
  • the present invention also provides a control method applied to the above-mentioned left atrial appendage ablation device, the method comprising:
  • the occluder is delivered to the opening of the left atrial appendage by using the delivery device to be released to occlude the opening of the left atrial appendage, and the first conductive portion is located at a first preset position;
  • the stent is controlled to move proximally relative to the occluder until it is separated from the occluder and withdrawn from the body, and the occluder is indwelled in the body.
  • the proximal end of the occluder covers the opening of the left atrial appendage, while the distal end of the occluder is fixed in the lumen of the left atrial appendage, and the circumferential surfaces of the two Both are used to abut against the left atrial appendage tissue, thereby firmly sealing the opening of the left atrial appendage.
  • pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue by using the first conductive part on the occluder and the second conductive part on the stent, thereby realizing one-stop treatment of ablation function and occlusion function.
  • the left atrial appendage ablation device of the present invention integrates two functions of occlusion and ablation, so that when applied to left atrial appendage ablation and occlusion, it can reduce the difficulty of positioning at the mouth of the left atrial appendage, simplify the operation procedure, and help shorten the operation time. Improve the convenience of "ablation + left atrial appendage closure" one-stop treatment operation.
  • FIG. 1 is a schematic diagram of the principle structure of a left atrial appendage ablation device provided by the present invention
  • FIG. 2 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the first embodiment
  • FIG. 3 is a schematic three-dimensional structural diagram of the stent of the left atrial appendage ablation device provided by the present invention under the first embodiment
  • Fig. 5 is the perspective structural schematic diagram of the bracket under the first embodiment
  • FIG. 6 is a schematic three-dimensional structure diagram of the support under the second embodiment
  • FIG. 7 is a schematic three-dimensional structure diagram of a bracket under the third embodiment.
  • FIG. 8 is a schematic three-dimensional structure diagram of a bracket under the fourth embodiment.
  • FIG. 9 is a schematic view of the front structure of the bracket under the fifth embodiment.
  • Fig. 10 is a top-view structural schematic diagram of the bracket in Fig. 9;
  • FIG. 11 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the second embodiment
  • FIG. 12 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the third embodiment
  • FIG. 13 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the fourth embodiment
  • FIG. 14 is a flowchart of a control method of a left atrial appendage ablation device provided by the present invention.
  • FIG. 15 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the fifth embodiment
  • FIG. 16 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the sixth embodiment
  • FIG. 17 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the seventh embodiment
  • FIG. 18 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the eighth embodiment.
  • FIG. 19 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the ninth embodiment.
  • FIG. 20 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the tenth embodiment
  • Fig. 21A is a schematic front view of the structure of the stent under the sixth embodiment.
  • FIG. 21B is a schematic three-dimensional structure diagram of a stent under the sixth embodiment.
  • Figure 22 is a schematic front view of the structure of the bracket under the seventh embodiment
  • FIG. 23 is a schematic front view of the structure of the bracket under the eighth embodiment.
  • FIG. 24 is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the eleventh embodiment.
  • FIG. 1 is a schematic diagram of the principle structure of the left atrial appendage ablation device provided by the present invention
  • the rear half of the left atrial appendage ablation device 1 is eliminated.
  • the overall structure of the left atrial appendage ablation device 1 It can be understood that, the left atrial appendage ablation device in the following embodiments is processed with reference to this processing manner.
  • the left atrial appendage ablation device 1 includes an occluder 11 and a delivery device 12 for delivering the occluder 11 , wherein the occluder 11 is used to be inserted into the opening of the left atrial appendage to block the left atrial appendage.
  • the conveyor 12 includes a holder 121 that is movable relative to the occluder 11 .
  • the stent 121 is positioned and released outside the occluder 11 and can move inside the occluder 11 at least in the delivery state, and in some embodiments, the stent 121 can also be positioned and released from the occluder 11 internal.
  • the occluder 11 is provided with a first conductive portion 1111 for transmitting the first ablation energy to the tissue.
  • a second conductive portion 1211 is provided on the stent 121 for transmitting the second ablation energy to the tissue.
  • the first ablation energy and the second ablation energy have opposite polarities.
  • the first conductive portion 1111 and the second conductive portion 1211 are electrically connected to the corresponding external ablation signal source, and transmit energy for ablating the corresponding tissue of the left atrial appendage, thereby realizing tissue ablation.
  • the ablation signal source is used to provide ablation energy for the first conductive portion 1111 and the second conductive portion 1211, and the specific first ablation energy and the second ablation energy may be high-voltage pulse ablation energy with opposite polarities, or are radiofrequency ablation energies of opposite polarity.
  • the left atrial appendage ablation device 1 is in the overall structure of a rotating body, and the occluder 11 includes a sealing portion or a sealing disc 112 at the proximal end (ie, the lower end in the figure), and a sealing portion at the distal end (ie, the upper end in the figure) 112 .
  • Anchor or anchor disc 111 is attached to the occluder 11 at the proximal end (ie, the lower end in the figure), and a sealing portion at the distal end (ie, the upper end in the figure) 112 .
  • the sealing part or the sealing disc 112 is used to cover the opening of the left atrial appendage
  • the anchoring part or the anchoring disc 111 is used to be fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of both are used to abut against the left atrial appendage tissue on the left atrial appendage, thereby firmly blocking the opening of the left atrial appendage.
  • the sealing part or the sealing disc 112 of the occluder 11 forms a covering for the opening of the left atrial appendage
  • the anchoring part or the anchoring disc 111 It is fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of both are used to abut against the tissue of the left atrial appendage, thereby stably blocking the opening of the left atrial appendage.
  • pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue by using the first conductive portion 1111 on the occluder 11 and the second conductive portion 1211 on the stent 121, thereby realizing a combination of ablation function and occlusion function. standing therapy.
  • the left atrial appendage ablation device of the present invention integrates two functions of occlusion and ablation, so that when applied to left atrial appendage ablation and occlusion, it can reduce the difficulty of positioning at the mouth of the left atrial appendage, simplify the operation procedure, and help shorten the operation time. Improve the convenience of "ablation + left atrial appendage closure" one-stop treatment operation.
  • the pulse ablation uses a high-intensity pulsed electric field to cause irreversible electroporation of the cell membrane (i.e., Irreversible electroporation, IRE), thereby causing cell apoptosis, and then achieving non-thermal effect ablation of cells. Not affected by heat sink effects.
  • the high-voltage pulse sequence produces less heat and does not require saline flushing for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombosis.
  • the pulse ablation treatment time is short, the treatment time of applying a group of pulse sequences is less than one minute, and the whole ablation time is generally not more than five minutes. And because the response thresholds of different tissues to the pulsed electric field are different, it is possible to ablate the myocardium without disturbing other adjacent tissues, thereby avoiding accidental injury to the tissues adjacent to the left atrial appendage.
  • Electrodes that release pulse energy can also collect intracardiac electrical signals. Before ablation, the collected intracardiac electrical signals are transmitted to the ECG synchronizer, so that the pulse output is synchronized in the absolute refractory period of myocardial contraction, so as not to interfere with the heart rate and reduce sudden changes. Cardiac arrhythmia; after ablation is complete, the complete electrical isolation of the tissue can also be determined by intracardiac signals.
  • the stent 121 can move proximally and distally relative to the occluder 21 in the axial direction, so as to flexibly adjust the relative position between the first conductive portion 1111 and the second conductive portion 1211, and the ablation electric field region formed between the first conductive portion 1111 and the second conductive portion 1211 . Therefore, the position of the stent 21 can be adjusted according to the anatomical structure of the patient's left atrial appendage to set a better ablation area, so that a closed annular electrical isolation band is formed in the inner cavity of the left atrial appendage to improve the efficiency and success rate of ablation.
  • the stent 121 can also move toward the proximal end relative to the occluder 11 along the axial direction of the occluder 11 so as to be separated from the occluder 11 . That is, after the ablation is completed, the occluder 21 is placed in the left atrial appendage, and the handle in the delivery device controls the stent 121 and the second conductive portion 1211 to move proximally and withdraw from the body.
  • the stent 121 that is not used to block the left atrial appendage in the left atrial appendage ablation device 1 is withdrawn from the body, so that the structure of the medical device indwelling the body is relatively simple, and the safety for the patient is higher.
  • the bracket 121 can also move along a path inclined to the axis of the occluder 11 body, so as to adjust the position of the bracket 21 according to the anatomical structure of the left atrial appendage of the patient to set a better ablation area, A closed annular electrical isolation band is formed in the inner cavity of the left atrial appendage, and the efficiency and success rate of ablation are improved.
  • the left atrial appendage ablation device 2 includes an occluder 21 and a delivery device 22 .
  • the delivery device 22 includes a handle 223 and an outer sheath 222 connected to the handle 223.
  • the distal end of the outer sheath 222 is detachably connected to the proximal end of the occluder 21, and the operator controls the occlusion through the outer sheath 222. position of the device 21.
  • the outer sheath tube 22 is in the shape of a hollow tube, and is also used to provide a channel for the stent 221, as well as other catheters, guide wires, etc., which can move relative to the occluder 21 in the axial direction.
  • the occluder 21 includes an anchoring disc 211 and a sealing disc 212, wherein the sealing disc 212 is used to cover the opening of the left atrial appendage to form a occlusion of the opening of the left atrial appendage, and the anchoring disc 211 is used to be fixed to the left atrial appendage.
  • the occluder 21 is integrally fixed with the lumen tissue of the left atrial appendage.
  • the first conductive portion 2111 is disposed on the anchoring plate 211 .
  • the first conductive parts 2111 are arranged in the circumferential direction of the anchoring plate 211 and form a ring shape, which can be arranged in one circle or multiple circles, and the multiple circles of the first conductive parts 2111 can be connected to each other to The ablation power with the same parameters is delivered.
  • the multi-turn first conductive parts 2111 are multiple first conductive parts 2111 , that is, the number of the first conductive parts 2111 can be multiple, and different first conductive parts 2111 are used for the transmission parameters of the same or different Ablation electrical energy, such as ablation electrical energy of different polarities.
  • the form of the first conductive part 2111 is not limited to a ring shape, and can also be electrode parts of other shapes, such as point electrodes, rod electrodes, wave electrodes, partial ring electrodes, etc., or a part of the frame is used as the first conductive part.
  • Section 2111 One of the first conductive parts 2111 can be disposed on the sealing part, and the other conductive part 2111 can be disposed on the anchoring part. Between the first conductive parts 2111 for transmitting pulsed ablation electrical energy with different polarities, it is used to generate a pulsed ablation electric field. Myocardial tissue in the ablation electric field above the threshold electric field strength of myocardial cells can be electrically ablated, so as to realize the left atrial appendage electrical field. isolation.
  • the stent 221 may only be used for mapping, ie, acquiring electrophysiological signals in the target tissue region.
  • the first conductive portion 2111 may also be disposed on the sealing disk 212 .
  • the anchoring disk 211 and the sealing disk 212 are of separate structures, that is, a connecting member is provided between the sealing disk 212 and the anchoring disk 211 for connection.
  • the sealing disc 212 and the anchoring disc 211 are respectively laser-cut from metal pipes, and are integrated into one body by connecting pieces or welding or bonding. It can be understood that, in the modified embodiment, at least one of the sealing disc 212 and the anchoring disc 211 is made of woven wire. In one embodiment, the sealing disc 212 and the anchoring disc 211 are integrally cut or integrally woven. In some embodiments, at least a portion of the sealing disk 212 is made of an insulating material, and/or at least a portion of the anchoring disk 211 is made of an insulating material.
  • both the sealing disc 212 and the anchoring disc 211 have a multi-mesh frame body.
  • the multi-mesh frame body has more supports to enhance the overall structural strength.
  • the contact area with the inner wall of the left atrial appendage is also increased, which helps to improve the uniformity of the force applied by the occluder 21 to the inner wall of the left atrial appendage, so as to form a better occlusion effect.
  • the first conductive portion 2111 is disposed adjacent to the distal end of the occluder 21.
  • the frame body of the anchoring disc 211 includes a trunk rod 2112 radially outward from the center of the disc body.
  • the conductive parts 2111 are connected to the adjacent trunk rods 2112 .
  • the first conductive portion 2111 includes a plurality of inter-rod connecting rods 2113 that are connected to the main rod 2112 and are connected to each other, and the inter-rod connecting rods 2113 here are conductors. More specifically, the inter-rod connecting rods 2113 are straight rod bodies, and the inter-rod connecting rods 2113 connected to each other form a first zigzag wave, that is, a zigzag wave. The crest of the first zigzag wave is connected with the end of the trunk rod 2112 , and at the position of the wave trough, a connecting piece is also provided, and the connecting piece is an inter-frame connecting rod 2114 .
  • the anchoring plate 211 further includes a second zigzag wave that is mirror-symmetrical to the first zigzag wave, that is, a zigzag wave.
  • the second zigzag wave is arranged at the other end of the interframe connecting rod 2114 , and the crest of the second zigzag wave is connected to the interframe connecting rod 2114 .
  • the folded skeleton 2115 is also connected to the trough of the second zigzag wave in the direction of the axis of the disc body.
  • the folded skeleton 2115 provided can reduce the possibility of tissue damage caused by the anchoring disc 211 .
  • the inter-frame connecting rod 2114 can also be a straight rod body, and barbs can be provided on it.
  • the barbs are formed by cutting the inter-frame connecting rods 2114 , in which case the cutting barbs will form corresponding slots on the inter-frame connecting rods 2114 .
  • the frame body of the anchoring plate 211 is a conductive metal frame body.
  • insulation treatment can be performed at the corresponding position on the frame body to obtain a structure different from the corresponding first
  • an insulating coating or an insulating film is applied to the frame outside the area of the first conductive portion 2111 .
  • the first conductive portion 2111 and the anchoring plate 211 are integrally formed.
  • the first conductive part 2111 may also be an electrode member additionally disposed on the anchoring plate 211, and the electrode member may be a ring electrode, a rod-shaped electrode, a sheet-shaped electrode Electrodes, wire electrodes, point electrodes, etc., the material of the electrode member is conductive metal, and the material of the electrode member and the anchor disk 211 can be different, for example, the material of the electrode member can provide better conductive parameters to improve ablation performance .
  • the frame body of the anchoring disk 211 can also be an insulating frame body.
  • the first conductive portion 2111 can also be an insulating frame body.
  • a blocking membrane can be provided on the anchoring disc 211 and/or the sealing disc 212 to prevent the thrombus deep in the left atrial appendage from entering the left atrium, while in other embodiments, the blocking membrane The fluid membrane may further serve to prevent blood flow at the opening of the left atrial appendage.
  • the delivery device 22 includes a bracket 221 , an outer sheath tube 222 and a handle 223 .
  • the stent 221 can be connected to the inner sheath 224
  • the inner sheath 224 can be located in the outer sheath 222
  • the distal end of the outer sheath 222 is detachable from the proximal end of the occluder 21 connections, such as screw connections.
  • the outer sheath tube 222 is tubular and has a channel for inserting the stent 221 and the inner sheath tube 224 and moving relative to the occluder 21 therein.
  • the proximal end of the sealing disc 212 is electrically connected to the external ablation signal source 24 through a conductive member (not shown in the figure), and the conductive member may be a conductive wire or a conductive tube.
  • the conductive member is connected to an external ablation signal source through the outer sheath tube 222 and the handle 223 to provide the first ablation energy for the first conductive portion 2111 on the anchoring disc 211 .
  • the bracket 221 is an umbrella-shaped frame body arranged radially, and the second conductive portion 2211 is disposed on the umbrella-shaped frame body.
  • the occluder 21 includes a hollow channel 213 , and the hollow channel 213 passes through the sealing disc 212 and the anchoring disc 211 .
  • both the sealing disk 212 and the anchoring disk 211 are in the shape of a hollow mesh, and the hollow channel 213 may be a space surrounded by the sealing disk 212 and the anchoring disk 211 , and a space where the sealing disk 212 and the anchoring disk 211 communicate with each other. The combination.
  • the inner cavity of the outer sheath tube 222 is communicated with the hollow channel 213, and the inner sheath tube 224 and the bracket 221 accommodated in the inner sheath tube 224 are used to pass through the outer sheath tube 222 and the hollow channel 213 and enter the Inside the occluder 21 .
  • the stent 221 is used to be released from the inner sheath tube inside or at the distal end of the occluder 21 , and the first conductive portion 2111 is disposed adjacent to the distal end of the occluder 21 .
  • the bracket 221 is made of metal as a whole, and the corresponding positions of the bracket 221 are insulated to obtain an insulating portion that is different from the corresponding second conductive portion 2211 .
  • the frame body other than the area 2211 is insulated by coating an insulating coating or adhering an insulating film.
  • the second conductive portion 2211 and the bracket 221 are integrally formed.
  • the second conductive portion 211 and the bracket 211 made of conductive material are separate structures, that is, the second conductive portion 211 is an additional electrode member disposed on the bracket 211 .
  • the bracket 221 is an insulating frame. At this time, a corresponding second conductive portion 2211 is obtained by arranging a metal piece at a corresponding position of the bracket 221 as an electrode piece.
  • FIG. 3 is a schematic three-dimensional structure diagram of the bracket under the first embodiment
  • FIG. 4 is a top-view structure diagram of the bracket under the first embodiment
  • FIG. 5 is the bracket under the first embodiment.
  • the umbrella-shaped frame body of the bracket 221 includes a plurality of umbrella ribs 2212 radially arranged around its axis
  • the second conductive part includes bracket connecting rods 2213 connected to each other
  • two adjacent bracket connecting rods 2213 are connected in a V shape. structure, and the two sides of the open end of the V-shaped structure are respectively used to connect with the adjacent umbrella ribs 2212 .
  • the structure formed by the interconnected support connecting rods 2213 can also form a zigzag wave, that is, a zigzag wave, and the crest of the zigzag wave is connected to the end of the umbrella rib 2212, and the trough is connected to the umbrella.
  • the crimped portion 2214 is bent in the axial direction of the stent-like body, and the crimped portion 2214 can be used to prevent the end of the stent 221 from damaging the inner wall tissue of the left atrial appendage.
  • the structure of the curling portion 2214 may also be omitted from the bracket 221.
  • the structures shown in FIGS. 3 and 4 correspond to the stent structure in FIG. 2 .
  • the inner sheath tube 224 is a hollow tube body. During the delivery process, the stent 211 is completely accommodated in the inner sheath tube 224 . After the end reaches the predetermined position, the stent 221 protrudes from the distal end of the inner sheath tube 224 .
  • the inner sheath tube 224 is used to deliver the stent in the outer sheath tube 222 and the hollow channel 213 of the occluder 21 .
  • the distal end of the inner sheath tube 224 is used for positioning at the distal end of the channel of the occluder 21, and the stent 221 is used for releasing at the distal end of the occluder fixed to the mouth of the left atrial appendage.
  • the conveyor 22 may further include a pulling member 225 , and the pulling member 225 is accommodated in the hollow pipe 213 .
  • the pulling member 225 can also be a tubular structure, or a solid rod body, a steel cable, etc., which is used to control the movement of the stent 221 and is also used to connect the ablation signal source, which is the first part on the stent 221.
  • the two conductive parts 2211 provide the second ablation energy.
  • the distal end of the pulling member 225 is connected to the proximal end of the stent 221, and can move along the hollow channel 213 in the inner sheath tube 224 together with the stent 221, so as to pull the stent.
  • FIG. 6 is a schematic diagram of the three-dimensional structure of the bracket under the second embodiment
  • FIG. 7 is a schematic diagram of the three-dimensional structure of the bracket under the third embodiment
  • FIG. 8 is the bracket under the fourth embodiment.
  • FIG. 9 is a schematic diagram of the front structure of the bracket in the fifth embodiment
  • FIG. 10 is a schematic diagram of the top-view structure of the bracket in FIG. 9 .
  • the bracket 221 ′ includes a straight rod body, and the second conductive portion 2211 ′ is disposed at the end of the distal end of the bracket 221 ′, and is also a straight rod body.
  • the proximal end of the stent 221 ′′ is used to be accommodated in the inner sheath tube, and has an exposed portion extending out of the inner sheath tube, and the second conductive portion 2211 ′′ is disposed on the exposed portion.
  • the exposed portion of the stent 221 ′′ includes a plurality of helical rods, and each helical rod is coiled in the circumferential direction from the proximal end to the distal end, so that the stent 221 ′′ is a helical frame body.
  • a second conductive portion 2211 ′′ is provided in the middle of each helical rod body.
  • the stent 221′′ also includes two pulling members 2216 and 2217 sleeved with each other. The end is connected to the distal end of the above-mentioned multiple helical rod bodies, and the distal end of the other pulling member 2217 is connected to the proximal end of the above-mentioned multiple helical rod bodies.
  • the relative movement of the two pulling members in the axial direction can realize the diameter of the stent 221 ′′ change to size.
  • the stent 221′′ includes a ring body 2218 disposed at the distal end and a straight rod body 2219 disposed at the proximal end.
  • the straight rod body 2219 is used to be disposed in the inner sheath, and the second conductive portion 2211 ′ ⁇ set on the ring body.
  • the second conductive portion 2211′′ includes a plurality of parts that are spaced in sequence along the extending direction of the ring body (ie, the circumferential direction), for example, parts that are spaced sequentially along the extending direction of the ring body (ie, the circumferential direction). Multiple electrode pieces.
  • the axis of the ring body 2218 and the axis of the straight rod body 2219 are eccentrically arranged. It can be understood that the axis of the ring body 2218 may be coaxial with the rod axis of the straight rod body 2219 .
  • the stent can also be in the form of a mesh basket body, and the second conductive portion is disposed on the mesh basket body to transmit the second ablation energy to the tissue.
  • the bracket 221′′′′ includes a braided mesh disc set at the distal end and a straight rod body set at the proximal end. After the bracket 221′′′′ is released, the straight rod body is used to set the In the inner sheath, the second conductive portion 2211′′′′ is disposed on the braided mesh disc.
  • the stent 221 ′′′′ in this embodiment is a conductor, so the entire stent can be used as an electrode to transmit ablation energy to the tissue.
  • the bracket 221 provided by the present invention can be a conductor, and the second conductive portion 2211 is located in a predetermined conductive area of the bracket 221 (which can be set according to different requirements), wherein the surface of the predetermined conductive area is It is conductive and does not need to be insulated.
  • the area other than the preset conductive area is an insulated area.
  • the surface of the insulated area needs to be insulated.
  • the position of the conductive area is preset, or the insulating film is adhered to the position of the non-predetermined conductive area of the bracket.
  • the second conductive portion 2211 may further include an electrode member such as a metal member for connecting with an external power source.
  • the second conductive portion 2211 can not only transmit the second ablation energy to the tissue, but also collect electrophysiological signals in the target tissue area, so as to monitor in real time whether the inner wall of the left atrial appendage is completely ablated. In some embodiments, the second conductive portion 2211 can deliver a second ablation energy to the tissue, or collect electrophysiological signals in the target tissue region.
  • the occluder 21 includes a hollow channel, and the inner cavity of the outer sheath tube 222 communicates with the hollow channel.
  • the inner sheath tube 224 and the bracket 221 accommodated in the inner sheath tube 224 are used to pass through the outer sheath tube 224.
  • the sheath tube 222 and the hollow channel enter into the occluder 21 , and the stent 221 is used to be released from the inner sheath tube 224 at the inner or distal end of the occluder 21 .
  • FIG. 11 it is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the second embodiment. Similar to the first embodiment, the left atrial appendage ablation device 3 in this embodiment also includes an occluder 31 and a delivery device 32.
  • the delivery device 32 includes a handle 323 and an outer sheath 322 connected to the handle 323.
  • the sheath tube 322 is used to provide a channel for the stent 321 to move relative to the occluder 31 .
  • the occluder 31 has a one-piece braided structure, including a semi-closed mesh cage body. It can be understood that the semi-closed structure has a cavity that accommodates the stent 321 in an expanded state or a collapsed state, and The cavity is also provided with structural forms such as through holes for extending the inner sheath tube and the bracket 321 or open openings. Structures without corresponding openings or through holes are closed.
  • the semi-closed mesh cage body is a cylindrical body with a hollow surface, and a braided mesh formed of braided wires is provided on the side surface, the proximal end and the distal end.
  • the semi-closed mesh cage body has a cavity, and a through hole for extending the inner sheath tube is arranged at its distal end.
  • the stent 321 is located in the inner sheath in the retracted state.
  • the through hole is a channel in a steel sleeve at the distal end of the occluder 31 , and the steel sleeve is tubular and used to accommodate and fix the ends of a plurality of braided wires.
  • the through holes are mesh holes formed between braided wires.
  • the semi-closed mesh cage body includes an anchoring part 311 and a sealing part 312, wherein the sealing part 312 is used to cover the opening of the left atrial appendage to form a blockage of the opening of the left atrial appendage, and the anchoring part 311 is used for fixing In the lumen of the left atrial appendage, the occluder 31 is integrally fixed with the lumen of the left atrial appendage.
  • the first conductive portion 3111 is provided on the anchor portion 311 . It can be understood that, in other variant structures of this embodiment, the first conductive portion 3111 can also be provided on the sealing portion 312 .
  • the first conductive portion 3111 includes an electrode member 313 for connecting with an external power source.
  • the electrode member 313 is annularly wrapped around the peripheral surface of the anchoring portion 311, as shown in FIG. 11 .
  • the electrode member 313 is disposed at a position of the anchor portion 311 near the axial middle section of the occluder 31 , and the surfaces of the electrode member 313 are all used to transmit ablation energy to the tissue.
  • the electrode member 313 includes a ring-shaped carrier, and a plurality of ring electrodes arranged on the carrier at intervals, wherein the carrier is not used to transmit ablation energy to the tissue, and the ring electrodes are used to transmit ablation energy to the tissue.
  • the electrode member 313 is used for ablation to avoid short circuit between the electrode member 313 and the frame of the occluder 31 .
  • the first conductive part 3111 can also be other forms of electrode parts provided on the anchor part 311, and the electrode parts can be ring electrodes, rod electrodes, sheet electrodes, wire electrodes, point electrodes, etc.
  • the material of the electrode member and the anchor portion 311 of the occluder 31 is conductive metal, and the material of the electrode member and the anchor portion 311 can be different, for example, the material of the electrode member can provide better conductivity parameters to improve the ablation performance.
  • the occluder 31 is provided with a plurality of first conductive parts 3111 arranged at intervals, in a preferred embodiment, the axial positions occupied by different first conductive parts 3111 are different, Optionally, different first conductive parts 3111 are used to transmit ablation power with different parameters, such as ablation power with different polarities.
  • the frame body of the occluder is electrically conductive, and the other first conductive parts 3111 in the plurality of first conductive parts 3111 can be in the form of electrode pieces disposed on the occluder. It can be understood that the first conductive portion 3111 may be disposed on the sealing portion 312 . .
  • a hollow pipe is provided at the central axis of the semi-closed mesh cage body of the occluder 31, and the bracket 321 and the inner sheath tube can protrude from the semi-closed mesh cage body through the hollow pipe. outside.
  • the left atrial appendage ablation device 3 uses the sealing portion 312 of the occluder 31 to cover the opening of the left atrial appendage, the anchoring portion 311 is fixed in the inner cavity of the left atrial appendage, and the circumferential surfaces of the two are used to abut the opening of the left atrial appendage. It is pressed against the left atrial appendage tissue, thereby firmly blocking the opening of the left atrial appendage.
  • pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue by using the first conductive portion 3111 on the occluder 31 and the second conductive portion 3211 on the stent 321, thereby realizing a combination of ablation function and occlusion function.
  • the risk of generating instrument thrombus in the conductive area of the left atrial appendage ablation device can also be reduced, and the electrode can be prevented from penetrating from the skeleton.
  • the phenomenon of upper separation occurs, which improves the reliability of the application.
  • FIG. 12 it is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the third embodiment. Similar to the second embodiment, the left atrial appendage ablation device 4 also includes an occluder 41 and a delivery device 42.
  • the delivery device 42 includes a handle 423 and an outer sheath 422 connected to the handle 423. It is used to provide a channel that can move relative to the occluder 41 for the bracket 421 .
  • the same parts please refer to the descriptions of the second embodiment and the related parts of the first embodiment, which will not be repeated here.
  • the occluder 41 is an integral structure, including a closed mesh cage body, and has a cavity structure, and the bracket 421 is arranged in the cavity structure, that is, the inside of the occluder.
  • the occluder 41 also includes an anchoring part 411 and a sealing part 412.
  • the first conductive part 4111 is located at the distal end of the closed mesh cage body, and is specifically arranged on the anchoring part 411.
  • 411 may include a pole piece 413 for connection with an external power source.
  • the bracket 421 is used to be positioned inside the closed mesh cage body, so the second conductive portion 4211 is used to be released in the closed mesh cage body, and is connected with the second conductive part 4211 located outside the closed mesh cage body.
  • a conductive part 4111 transmits ablation energy to the tissue to achieve ablation of the tissue.
  • the stent 421 is released in the occluder 41 at a position close to its proximal end, that is, a position corresponding to the sealing portion 412 . It can be understood that, in other embodiments, the stent 421 is released in the occluder 41 at a position close to its distal end, that is, the position corresponding to the anchoring portion 411 .
  • FIG. 13 it is a schematic structural diagram of the left atrial appendage ablation device provided by the present invention under the fourth embodiment. Similar to the third embodiment, the left atrial appendage ablation device 5 also includes an occluder 51 and a delivery device 52.
  • the delivery device 52 includes a handle 523 and an outer sheath 522 connected to the handle 523. It is used to provide a channel for the bracket 521 that can move relative to the occluder 51 .
  • the same parts please refer to the related descriptions of the third embodiment and the foregoing embodiments, which will not be repeated here.
  • the occluder 51 has a one-piece braided structure, including a semi-closed mesh cage body, an opening 514 is provided at the distal end of the occluder 51, and the stent 521 is in a contracted state. Or in the unfolded state, it can protrude from the opening 514 at the distal end of the semi-closed mesh cage body. It can be understood that the same mesh cage effect can be achieved by the integral structure obtained by cutting the pipe material or the integral structure obtained by weaving the wire material.
  • the occluder 51 includes an anchoring part 511 and a sealing part 512 , and the stent 521 is in a deployed state and is disposed inside the semi-closed mesh cage body, close to the distal end of the occluder 51 , namely Corresponding to the position of the anchor portion 511 .
  • the second conductive portion 5211 is located at the distal end of the semi-closed mesh cage body, and the first conductive portion 5111 of the occluder 51 includes an electrode member 513 for connecting with an external power source.
  • the occluder is a frame structure:
  • the first conductive part is used to transmit the first ablation energy to the tissue to realize the ablation function of the tissue, and it can obtain an uninsulated preset conductive area by insulating the corresponding part of the metal frame of the occluder. It can also be made by arranging ring electrodes, rod electrodes, sheet electrodes, wire electrodes, and point electrodes in the corresponding parts of the frame structure of the occluder.
  • the connection with the frame body structure of the occluder can also be realized by a connecting piece to the frame body structure of the occluder, or it can be intertwined and fixed with the frame body structure.
  • the conductive portions of the first conductive portion can be arranged in a continuous arrangement or arranged at preset intervals.
  • the second conductive part is used to transmit the second ablation energy to the tissue to realize the ablation function of the tissue. Similar to the first conductive part, the second conductive part can also be used to perform the ablation on the corresponding part of the specific metal structure. Insulation treatment is made to obtain an uninsulated preset conductive area, and it can also be made by arranging point electrodes, electrode wires, electrode sheets, electrode rings and electrode rods on the corresponding parts of the bracket. It can be bonded to the bracket structure, or can be connected to the frame structure of the occluder through a connecting piece, or can be intertwined and fixed with the frame structure.
  • each part of the second conductive part can be arranged in a continuous arrangement or arranged at preset intervals.
  • At least one of the first conductive parts and the second conductive parts is a preset conductive area obtained by insulating the metal main body (the whole of the occluder is made of metal material, and the whole of the bracket is made of metal material).
  • the first conductive part is integrated with the occluder and/or the second conductive part is integrated with the stent, the risk of instrument thrombus being generated in the conductive area on the left atrial appendage ablation device can also be reduced, and the electrode can be prevented from being removed from the skeleton. The phenomenon of separation occurs, which improves the reliability of the application.
  • the projections of the first conductive portion and the second conductive portion on the axis of the occluder are at least not completely coincident, and preferably, the projections of the first conductive portion and the second conductive portion on the axis of the occluder are different from each other Coincidence, that is, staggered arrangement, is beneficial to reduce the probability of a short circuit caused by contact between the first conductive portion and the second conductive portion.
  • the left atrial appendage ablation device provided by the present invention may further include a delivery sheath (not shown in the figure), in the delivery state: the occluder is in a radially compressed state and accommodated in the delivery sheath, and when it reaches the first preset position Afterwards, the occluder is released from the delivery sheath.
  • the occluder is expanded and fixed at the opening of the left atrial appendage, and the circumferential direction of the anchoring portion/anchoring disc and the inner cavity tissue of the left atrial appendage are mutually abutted, so that the first conductive portion can be in direct contact with the tissue of the left atrial appendage.
  • the stent is accommodated in the inner sheath tube in the delivery state, and enters the occluder with the inner sheath tube or extends from the distal end of the occluder until the distal end of the inner sheath tube reaches the corresponding position. Thereafter, the inner sheath tube and the pulling member are controlled to guide the stent to be released from the distal end of the inner sheath tube to a second preset position, that is, release at the distal end or inside of the occluder.
  • the ablation source is a pulsed ablation signal
  • the adherence of the second conductive part to the left atrial appendage tissue is not high, and the effect of irreversible electroporation ablation is not affected, so the setting position after release is relatively flexible, but preferably
  • the situation is that the second conductive portion on the bracket is staggered from the first conductive portion to avoid short circuit.
  • the first conductive part and the second conductive part are controlled to transmit ablation energy with opposite polarities to the tissue through the handle, so as to realize the ablation of the inner cavity of the left atrial appendage.
  • the handle controls the retractor to drive the stent back into the inner sheath, the inner sheath and the stent are withdrawn from the hollow channel and the outer sheath, and then the distal end of the outer sheath is separated from the proximal end of the occluder.
  • the handle drives the outer sheath tube and the stent to withdraw from the body.
  • FIG. 14 it is a flowchart of a control method of a left atrial appendage ablation device provided by the present invention, which is applied to the above-mentioned left atrial appendage ablation device, and the control method may include the following processes:
  • S101 Use a delivery device to deliver the occluder to the opening of the left atrial appendage and release it to block the opening of the left atrial appendage, and the first conductive portion is located at a first preset position.
  • the delivery device may specifically include the above-mentioned handle, outer sheath, inner sheath and support.
  • the occluder When the occluder is in a retracted state, the occluder is contained in an additional delivery sheath, and the outer sheath is connected to the outer sheath.
  • the proximal end of the occluder is connected and released after the first conductive portion is delivered to the first preset position, so as to expand to a size matching the opening of the left atrial appendage and occlude it.
  • the inner sheath located inside the outer sheath and the stent in the inner sheath move relative to the occluder, and are released at the corresponding position by the distal end of the inner sheath, so that the stent is in the second preset position location.
  • the first preset position may be the same as or different from the second preset position, wherein when they are the same, the projections of the two on the axis of the occluder are at least partially offset.
  • the stent is disposed in the inner sheath when it is in a retracted state, and is released after being delivered to the second preset position.
  • S103 Use the first conductive portion and the second conductive portion to transmit energy to the tissue region for ablation.
  • the ablation signal source is used to respectively provide ablation energy with opposite polarities to the first conductive part and the second conductive part, and transmit the ablation energy to the tissue through them for ablation.
  • the ablation situation can be monitored in real time, and when the monitoring shows that the ablation is completed, the stent is controlled to be retracted and retracted into the inner sheath. Afterwards, the inner sheath tube and the stent in the inner sheath tube move towards the proximal end relative to the occluder to separate from the occluder, thereby achieving relatively complete control of the left atrial appendage ablation treatment.
  • FIG. 15 is a schematic structural diagram of the left atrial appendage ablation device 6 according to the fifth embodiment. Similar to the left atrial appendage ablation device 5 in FIG. 13 , the left atrial appendage ablation device 6 of the present embodiment includes an occluder 61 and a delivery device.
  • the delivery device includes a handle and an outer sheath tube connected to the handle. The tube is used to provide a passage for the stent 621 to move relative to the occluder 61 .
  • the left atrial appendage ablation device 6 and the left atrial appendage ablation device 5 in FIG. 13 please refer to the relevant description of the part in FIG. 13 , which will not be repeated here.
  • the main difference between the left atrial appendage ablation device 6 and the left atrial appendage ablation device 5 in FIG. 13 is that the left atrial appendage ablation device 6 is a double-disc structure, and the relative positions of the first conductive portion 6111 and the second conductive portion 6211 are different from those in FIG. 13 . .
  • the left atrial appendage ablation device 6 includes a sealing part 612 and an anchoring part 611 , and a connecting piece 615 connected between the sealing part 612 and the anchoring part 611 .
  • the sealing portion 612 is in the shape of a disc, specifically a double-layer mesh disc shape, that is, it includes a distal frame body facing the anchoring portion 611 and a proximal frame body away from the anchoring portion 611 , and the distal frame body and the proximal frame body are sealed. The circumferential edges of the portion 612 meet.
  • the proximal frame body is roughly planar
  • the distal frame body is roughly planar
  • an inner cavity is formed between the proximal frame body and the distal frame body, and a flow blocking film can be arranged in the inner cavity as required.
  • the proximal frame body fits with the distal frame body.
  • a flow blocking film may be provided on the outer surface of the sealing portion 612 as required.
  • the sealing portion 612 is a single-layer mesh disk, that is, only one layer of frame body is included in the axial direction.
  • the anchoring portion 611 is in the shape of a disc, and further, the anchoring portion 611 is a semi-closed mesh cage body, that is, the anchoring portion 611 is a unilaterally closed structure, the proximal end thereof is connected with the connecting piece 615, and the distal end thereof is open In the form of , that is, the distal end is provided with an opening for the stent 621 to protrude from the semi-closed mesh cage body in the retracted state or the unfolded state. As shown in FIG.
  • the stent 621 is released at the proximal side (the side close to the sealing part 612 ) in the lumen of the anchoring part 611 , the stent 621 may not protrude from the distal end of the anchoring part 611 during use,
  • the second conductive portion 6211 provided on the bracket 621 is provided at the proximal end of the first conductive portion 6111 .
  • the stent 621 is used to protrude from the distal opening of the anchoring portion 621 , so that the second conductive portion 6211 is located at the distal end of the first conductive portion 6111 .
  • the first conductive portion 6111 is disposed on the sealing portion 612 .
  • Both the sealing part 612 and the anchoring part 611 in the occluder 61 provided in this embodiment are made by a weaving process.
  • at least part of the sealing part 612 can be made by a cutting process.
  • at least part of the anchoring portion 611 may be formed by a cutting process.
  • FIG. 16 is a schematic structural diagram of the left atrial appendage ablation device 7 according to the sixth embodiment.
  • the left atrial appendage ablation device 7 includes an occluder 71 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, and the outer sheath is used to provide the stent 721 with a relative The channel through which the occluder 71 moves.
  • the left atrial appendage ablation device 7 and the left atrial appendage ablation device 6 please refer to the relevant description of the left atrial appendage ablation device 6 , which will not be repeated here.
  • the main difference between the left atrial appendage ablation device 7 and the left atrial appendage ablation device 6 is that the structures of the sealing portion 712 and the anchoring portion 711 are different, and the specific structure of the stent 721 is the form shown in FIG. 8 .
  • the sealing portion 621 is in the shape of a double-layer mesh disk, the distal frame of the sealing portion 621 is arc-shaped, and the proximal frame of the sealing portion 621 is approximately flat.
  • the space occupied by the sealing portion 712 in the axial direction is compared with that of the sealing portion 612. Larger, it is convenient to improve the conformability of the sealing part 712, and it is convenient for the edge of the sealing part 712 to stick to the wall, so as to improve the sealing performance.
  • the anchoring portion 711 is a closed structure at both ends, and the bracket 721 is used to be released inside the anchoring portion 711 . Please refer to the related description of FIG. 8 for the specific structure of the bracket 721 .
  • FIG. 17 is a schematic structural diagram of the left atrial appendage ablation device 8 according to the seventh embodiment. Similar to the left atrial appendage ablation device 7, the left atrial appendage ablation device 8 includes an occluder 81 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, and the outer sheath is used to provide the stent 821 with a relative The channel through which the occluder 81 moves. The same parts of the left atrial appendage ablation device 8 and the left atrial appendage ablation device 7 are not repeated here.
  • the main difference between the left atrial appendage ablation device 8 and the left atrial appendage ablation device 7 is that the structures of the sealing portion 812 and the anchoring portion 811 are different, and the specific structure of the stent 821 is the form shown in FIG. 3 .
  • the sealing portion 812 is made of a braiding process, and includes a proximal frame body, a distal frame body, and a connecting portion connected between the proximal frame body and the distal frame body.
  • the proximal frame body is substantially flat
  • the distal frame body is substantially flat, and is disposed on the circumferential edge of the sealing portion 812 and is in the shape of a cone.
  • the anchoring portion 811 is made by a cutting process, and includes a main rod, a strut, an anchor rod and a bending rod which are connected in sequence.
  • the plurality of main rods, the plurality of anchor rods, and the plurality of bending rods all extend between the proximal end and the distal end.
  • One end of each main rod is connected to the connecting piece 815, the other end of each main rod is connected to two adjacent struts, and the distal ends of the two adjacent struts of the same main rod are connected, and extend in different directions.
  • the ends of the adjacent struts are connected in sequence in a zigzag shape, and a plurality of struts are connected in the circumferential direction to form a ring.
  • the other ends of the two adjacent struts that connect different main rods are connected to the distal end of the same anchor rod.
  • the anchor rod is relatively far from the main rod from the axis of the anchoring part 811, that is, the anchor rod is arranged on the main rod.
  • the periphery of the rod is used for contacting and fixing to the inner wall of the left atrial appendage.
  • the proximal end of each anchoring rod is connected to a bending rod.
  • the proximal end of the bending rod is set in the space enclosed by the main rod and the anchoring rod, and extends in the direction of the axis of the anchoring portion 811.
  • the end is bent toward the inside of the anchoring portion 811 , so as to reduce the possibility of damage to the tissue caused by the end of the anchoring portion 811 .
  • the distal ends of two adjacent bending rods are connected together, which improves the structural reliability of the anchoring portion 811 and prevents adjacent bending rods from being spliced together.
  • the present application does not limit the manufacturing process of the sealing portion 812 and the anchoring portion 811, and at least part of the two can be made by a weaving process or a cutting process.
  • the first conductive portion may be disposed on the sealing portion 812 or the anchoring portion 811 , and the first conductive portion may be a part of the frame body without insulation treatment, or may be an electrode member disposed on the occluder.
  • the bracket 821 adopts the form shown in FIG. 3 , for details, please refer to the foregoing description.
  • the release position of the specific bracket 821 can be adjusted as required, for example, it is released inside the sealing portion 812 .
  • the occluder 81 may be provided with a plurality of first conductive parts 8111 arranged at intervals.
  • different first conductive parts 8111 occupy different axial positions. part, and a first conductive part 8111 is arranged on the anchor part.
  • different first conductive parts 8111 are used to transmit ablation power with different parameters, such as ablation power with different polarities, in particular, such as pulse ablation power with different polarities, for transmitting pulse ablation power with different polarities.
  • the first conductive parts 8111 are used to generate a pulsed ablation electric field, which is used to ablate the tissue, and the left atrial appendage tissue in the electric field above the electric field strength of the cardiomyocyte ablation threshold can be ablated, so as to realize the electric field of the left atrial appendage. isolation.
  • Different first conductive parts 8111 may have different forms, and may be in the form of frame body conduction or additional electrode components.
  • one of the first conductive parts 8111 conducts electricity for the frame of the occluder
  • the other first conductive parts 8111 in the plurality of first conductive parts 8111 can be in the form of an electrode element disposed on the occluder, such as in
  • the first conductive portion of the sealing portion is a frame body in the sealing portion
  • the other first conductive portion 8111 of the anchoring portion is an electrode member disposed on the anchoring portion, and the form of the electrode member is not limited.
  • the first conductive portion 8111 may be provided on the sealing portion 312 or the anchoring portion, or at least one first conductive portion 8111 may be provided on the sealing portion, and at least one first conductive portion 8111 may be provided on the anchoring portion. department.
  • the stent may only be used for mapping, that is, to collect electrophysiological signals in the target tissue (intracardiac, or left atrial appendage).
  • FIG. 18 is a schematic structural diagram of the left atrial appendage ablation device 9 according to the eighth embodiment of the present invention. Similar to the left atrial appendage ablation device 8, the left atrial appendage ablation device 9 includes an occluder 91 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, and the outer sheath is used to provide the stent 921 with a relative The channel through which the occluder 91 moves. The same parts of the left atrial appendage ablation device 9 and the left atrial appendage ablation device 8 are not repeated here.
  • the main difference between the left atrial appendage ablation device 9 and the left atrial appendage ablation device 8 is that the structures of the sealing portion 812 and the anchoring portion 811 are different, and the specific structure of the stent 921 is the form shown in FIG. 8 .
  • the sealing portion 912 is made of a braiding process, and includes a proximal frame body and a distal frame body, and a waist portion connected between the proximal frame body and the distal frame body.
  • the proximal frame is approximately flat
  • the distal frame is approximately flat
  • the waist is approximately straight.
  • the anchoring portion 911 is made by a weaving process, and includes an inner frame body, an outer frame body and a bending frame body which are connected in sequence.
  • the inner frame body, the distal frame body and the bending frame body all extend between the proximal end and the distal end.
  • the proximal end of the inner frame body is connected to the connector 915, the distal end of the inner frame body expands radially into a horn shape, and a horn opening is formed at the distal end, the outer frame body is arranged on the periphery of the inner frame body, and the distal end of the inner frame body is The distal end of the outer frame body is connected, the proximal end of the outer frame body is connected to the proximal end of the bending frame body, the bending frame body is arranged in the space enclosed by the inner frame body and the outer frame body, and the distal end of the bending frame body
  • the axial direction of the anchoring portion 912 is extended to prevent the end of the anchoring portion 911 from damaging the tissue.
  • the first conductive portion 9111 is disposed on the sealing portion 912 and is in the form of an electrode member. It is understood that at least part of the frame on the sealing portion 912 can be used as the first conductive portion 9111 .
  • the stent 921 takes the form in FIG. 8 for release distal to the distal end of the anchor portion 911 , and in some embodiments, the stent 921 for release in the seal portion 912 .
  • FIG. 19 is a schematic structural diagram of the left atrial appendage ablation device 10 according to the ninth embodiment. Similar to the left atrial appendage ablation device 8, the left atrial appendage ablation device 10 includes an occluder 101 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, and the outer sheath is used to provide the stent 1021. The channel through which the occluder 101 moves. The same parts of the left atrial appendage ablation device 10 and the left atrial appendage ablation device 8 are not repeated here.
  • the main difference between the left atrial appendage ablation device 10 and the left atrial appendage ablation device 8 is that the structures of the sealing portion 1012 and the anchoring portion 1011 are different, and the specific structure of the stent 1021 is the form shown in FIG. 9 .
  • the sealing portion 1012 is made by weaving process, and includes a proximal disk surface and a distal disk surface.
  • the distal disk surface is tapered as can be seen from the figure, and the proximal disk surface can be tapered or roughly flat.
  • the difference between the anchoring part 1011 and the anchoring part 811 is that the distal ends of the adjacent bending rods in the anchoring part 1011 are spaced apart from each other and are not connected together.
  • the stent 1021 is used for release distal to the distal end of the anchor portion 1011 , and in some embodiments, the stent 1021 is used for release at the seal portion 1012 .
  • FIG. 20 is a schematic structural diagram of the left atrial appendage ablation device 20 according to the tenth embodiment of the present invention. Similar to the left atrial appendage ablation device 5, the left atrial appendage ablation device 20 includes an occluder 201 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, the outer sheath is used to provide the stent 2021. The channel through which the occluder 201 moves. The same parts of the left atrial appendage ablation device 20 and the left atrial appendage ablation device 5 are not repeated here.
  • the main difference between the left atrial appendage ablation device 20 and the left atrial appendage ablation device 5 is that the occluder 201 is made by a cutting process to form a large mesh structure, and the specific structure of the stent 2021 is the form shown in FIG. 6 .
  • the occluder 201 includes a plurality of support rods extending in the axial direction, and the support rods are connected to each other to obtain a large mesh structure.
  • the first conductive portion is disposed on the occluder 201, and specifically may be the entire frame body of the occluder 201, or a part of the frame body surface of the occluder 201 is conductive as the first conductive portion to ablate the tissue, and the first conductive portion is used to ablate the tissue.
  • a conductive part may also be an electrode member disposed on the occluder 201 .
  • the stent 2021 is in the shape of a straight rod, and some pre-bending angles can be set, that is, after the stent 2021 is released from the inner sheath, a certain angle is formed on the stent 2021, so that the distal end of the stent 2021 is at a distance from the inner sheath tube.
  • the occluder 201 is close to the tissue, or is closer to the tissue.
  • the stent 2021 is a bendable catheter, and the stent 2021 can be adjusted to bend as required, so that the stent 2021 can be ablated or mapped at the target position (such as a position close to the wall, or a position relatively close to the tissue wall) (collecting intracardiac electrical signals). physiological signals).
  • FIGS. 21A and 21B are schematic front views of the support 221a in the sixth embodiment.
  • the bracket 221a includes a plurality of fan-shaped rings arranged in sequence in the circumferential direction, and the projection of each ring-shaped ring on a plane perpendicular to its axis is a fan-shaped.
  • the projections have overlapping portions, and in other embodiments, the projections of adjacent sector rings on the plane do not overlap, or the overlapping portions are smaller or larger.
  • the positions of the two ends of the fan-shaped rings in the axial direction are not coincident, that is, they are staggered in the axial direction, thereby increasing the support performance of each fan-shaped ring.
  • the two ends of the sector ring are at the same position in the axial direction, and can be connected together or arranged at intervals.
  • the edge part of the fan-shaped ring can better abut against the tissue wall to ensure the effect of ablation and mapping.
  • the above-mentioned second conductive portion disposed on the support 221a may be at least a part of the support 221a, or the whole, or an electrode member disposed on the support 221a.
  • FIG. 22 is a schematic front view of the bracket 221b in the seventh embodiment.
  • the stent 221b is spherical, and its manufacturing process is not limited, and it can be obtained by weaving or cutting.
  • the distal end of the stent 221b can move toward the proximal end of the stent 221b under the control of the conveyor, for example, under the pulling action of the pulling member of the conveyor, so as to obtain a relatively large radial dimension.
  • the structure is convenient for the bracket 221b to stick to the wall.
  • the above-mentioned second conductive portion disposed on the support 221b may be at least a part of the support 221b, or the whole, or an electrode member disposed on the support 221b.
  • FIG. 23 is a schematic front view of the bracket 221c in the eighth embodiment.
  • the bracket 221c is similar to the bracket 221 in FIG. 3 and is an umbrella-shaped frame body, the difference is that the bracket 221c only includes a plurality of ribs 2212 radially arranged around its axis.
  • the second conductive portion is disposed on the plurality of ribs 2212, which may be at least part of the ribs 2212, or some electrode elements disposed on the ribs.
  • FIG. 24 is a schematic structural diagram of the left atrial appendage ablation device 21 according to the eleventh embodiment of the present invention. Similar to the left atrial appendage ablation device 8, the left atrial appendage ablation device 21 includes an occluder 201 and a delivery device, the delivery device includes a handle and an outer sheath connected to the handle, the outer sheath is used to provide the stent 2121 with a relative The channel through which the occluder 201 moves. The same parts of the left atrial appendage ablation device 21 and the left atrial appendage ablation device 8 are not repeated here.
  • the main difference between the left atrial appendage ablation device 21 and the left atrial appendage ablation device 8 is that the stent 2121 is in the form of a ring in FIG. 8 .
  • the bracket 2121 is in the form of a ring, which is convenient for its peripheral edge to stick to the wall for signal mapping. It can be understood that the stent 2121 may not have the function of ablation. In some embodiments, the stent 2121 may have functions of ablation and mapping.
  • the left atrial appendage ablation device in each of the above embodiments can use this control method to control the left atrial appendage ablation process, so that the left atrial appendage ablation device can stably block the opening of the left atrial appendage.
  • pulse ablation or radiofrequency ablation is performed on the left atrial appendage tissue by using the first conductive part on the occluder and the second conductive part of the stent, thereby realizing one-stop treatment of ablation function and occlusion function.
  • control method of the left atrial appendage ablation device can be mainly run as a program in a computer, and the computer can include: a processor, a memory, and a computer stored in the memory and running on the processor. procedures, such as control procedures for left atrial appendage ablation devices.
  • the processor executes the computer program, each step in the above control method is implemented, for example, steps S101 to S104 shown in FIG. 14 .
  • the processor executes the computer program, the functions of each module in the foregoing apparatus embodiment are implemented.

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Abstract

L'invention concerne un dispositif d'ablation d'appendice auriculaire gauche et un procédé de commande. Le dispositif d'ablation d'appendice auriculaire gauche comprend : un dispositif d'occlusion (11, 21, 31, 41, 51, 61, 71, 81, 91, 101, 201) conçu pour être placé au niveau d'une ouverture d'un appendice auriculaire gauche, une première partie conductrice (1111, 2111, 3111, 4111, 5111, 6111, 8111, 9111) se situant sur le dispositif d'occlusion pour transmettre une première énergie d'ablation vers des tissus ; et un élément d'acheminement (12, 22, 32, 42, 52, 62) conçu pour acheminer le dispositif d'occlusion (11, 21, 31, 41, 51, 61, 71, 81, 91, 101, 201) et comprenant une endoprothèse (121, 221, 321, 421, 521, 621, 721, 821, 921, 1021, 2021) capable de se déplacer relativement par rapport au dispositif d'occlusion (11, 21, 31, 41, 51, 61, 71, 81, 91, 101, 201), une seconde partie conductrice (1211, 2211, 3211, 4211, 5211, 6211) se situant sur l'endoprothèse (121, 221, 321, 421 521, 621 721, 821, 921, 1021, 2021) pour transmettre une seconde énergie d'ablation vers des tissus et/ou acquérir un signal électrophysiologique intracardiaque, la polarité de la première énergie d'ablation étant opposée à celle de la seconde énergie d'ablation. Au moyen de ce dispositif d'ablation d'appendice auriculaire gauche, on peut mettre en oeuvre à la fois un traitement d'ablation et des fonctions d'occlusion.
PCT/CN2021/140235 2020-12-21 2021-12-21 Dispositif d'ablation d'appendice auriculaire gauche et procédé de commande Ceased WO2022135424A1 (fr)

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CN115054362A (zh) * 2022-07-28 2022-09-16 杭州德诺电生理医疗科技有限公司 一种消融系统

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