CN215129380U

CN215129380U - Left auricle plugging device

Info

Publication number: CN215129380U
Application number: CN202022097048.2U
Authority: CN
Inventors: 王永胜; 尤岩; 刘成
Original assignee: Hangzhou Nori Medical Technology Co ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2020-09-22
Filing date: 2020-09-22
Publication date: 2021-12-14
Anticipated expiration: 2030-09-22

Abstract

The utility model provides a left auricle plugging device, it encapsulates stifled piece, connection the piece and the mark survey piece of melting of shutoff piece, the shutoff piece is used for fixing at left auricle opening part, it is used for transmitting to melt the energy with right target tissue area in the left auricle melts, mark survey piece is used for receiving electrophysiological signal with right target tissue area is surveyed. The left atrial appendage occlusion device can not only occlude the opening of the left atrial appendage, but also control the ablation piece to ablate the target tissue region in the left atrial appendage, and the mapping piece can map the electrical signal in the left atrial appendage to ensure that a complete at least one circle of ablation region is formed near the opening of the left atrial appendage to achieve a complete electrical isolation treatment effect.

Description

Left auricle plugging device

Technical Field

The utility model relates to an intervene medical instrument technical field, concretely relates to a left auricle plugging device for left auricle is ablated in shutoff.

Background

Atrial fibrillation (short for atrial fibrillation) is the most common persistent arrhythmia, and the incidence rate of atrial fibrillation is increased continuously with the increase of age, and the population over 75 years old can reach 10 percent. The exciting frequency of the atria during atrial fibrillation reaches 300-600 times per minute, the heartbeat frequency is often fast and irregular and sometimes reaches 100-160 times per minute, the heartbeat is much faster than that of a normal person and is absolutely irregular, and the atria lose effective contraction function. The incidence of atrial fibrillation is also closely related to coronary heart disease, hypertension, heart failure and other diseases.

Because the Left Atrial Appendage (LAA) has a special shape and structure, it is not only the most important site for thrombus formation in atrial fibrillation (atrial fibrillation), but also one of the key regions for its generation and maintenance, and some patients with atrial fibrillation can benefit from active electrical isolation of the left atrial appendage.

In order to prevent the left atrial appendage thrombus from causing stroke due to atrial fibrillation and blood flowing out of the heart, the percutaneous left atrial appendage occlusion device occludes the left atrial appendage by using a special occlusion device, and is a treatment method which is developed in recent years and has the advantages of small trauma, simplicity in operation and less time consumption. The basic structure of the existing left auricle plugging device is similar, namely, an expandable high molecular polymer film is coated outside a self-expansion nickel-titanium memory alloy cage-shaped structure support, and an anchor hook (similar to an agnail on a fishhook) is arranged on a rod of the nickel-titanium alloy support and can assist the device to be fixed in the auricle so as to avoid falling off. The high molecular polymer film can seal the entrance of the left auricle atrium, isolate the left auricle atrium and the left atrial body part, and prevent the blood flow from communicating. After the left atrial appendage occlusion device is placed, the endothelial cells of the left atrium can creep and grow on the surface of the high polymer film, and new endothelium is formed after a period of time.

However, the left atrial appendage occlusion alone can only serve to prevent stroke and cannot improve atrial fibrillation symptoms.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a left auricle plugging device, left auricle plugging device can realize shutoff, mark survey and melting to the left auricle inner wall.

In order to solve the technical problem, the utility model provides a left auricle plugging device, including shutoff piece, connection the piece and the mark survey piece of ablating of shutoff piece, the shutoff piece is used for fixing at left auricle opening part, it is used for transmitting and melts the energy with right to melt the target tissue region in the left auricle melts, mark survey piece is used for receiving electrophysiological signal with right the regional mark survey of target tissue.

Preferably, the ablating member and/or the mapping member are releasably attached to the occluding member.

Preferably, the multi-electrode catheter further comprises a multi-electrode catheter, wherein the blocking piece is a hollow structure, the multi-electrode catheter is detachably inserted into the blocking piece, the multi-electrode catheter comprises a distal end section at the distal end of the multi-electrode catheter, and the mapping piece is a plurality of mapping electrodes arranged on the distal end section of the multi-electrode catheter.

Preferably, the distal section of the multi-electrode catheter is configured to extend beyond the distal end of the occluding member such that the mapping electrode is in contact with the target tissue to receive electrophysiological signals.

Preferably, the ablation member is a plurality of ablation electrodes disposed on the distal end section, the plurality of ablation electrodes and the plurality of mapping electrodes are disposed at intervals at the distal end section, and the distal end section is configured to be received in the inner cavity of the occluding member or extend out of the distal end of the occluding member to deliver ablation energy to the target tissue region.

Preferably, the distal section of the multi-electrode catheter is pre-shaped into at least one annular structure.

Preferably, the distal section of the multi-electrode catheter is pre-shaped in a plurality of annular structures arranged in an axial direction, the diameter of the annular structures being smaller closer to the distal end.

Preferably, the multi-electrode catheter includes a plurality of carrier rods arranged in sequence in a circumferential direction, and distal ends and proximal ends of the plurality of carrier rods are respectively coupled together.

Preferably, the at least one carrier rod extends helically around the axial direction.

Preferably, on the multi-electrode catheter, the mapping electrode is disposed proximally relative to the ablation electrode.

Preferably, the multi-electrode catheter comprises a carrier member and a lead wire arranged on the carrier member, and the ablation electrode and the mapping electrode are electrically connected to an ablation energy source and a mapping signal receiver through the lead wire respectively.

Preferably, the ablating member is disposed on the occluding member.

Preferably, the blocking piece comprises an anchoring portion and a sealing portion connected to a proximal end of the anchoring portion, and the ablation electrode is arranged on the surface of the anchoring portion.

Preferably, the blocking piece comprises an anchoring portion and a sealing portion connected to the proximal end of the anchoring portion, at least one flow-blocking membrane is arranged in the sealing portion and/or the anchoring portion, and the distal end section of the multi-electrode catheter penetrates through the at least one flow-blocking membrane and is contained in the inner cavity of the sealing portion, the inner cavity of the anchoring portion or extends out of the distal end of the anchoring portion.

Preferably, the flow blocking film has elasticity, the flow blocking film comprises a plurality of sub-valves arranged around the perforation, a gap is arranged between every two adjacent sub-valves, and the perforation for the multi-electrode catheter to penetrate through is formed between the plurality of sub-valves; the plurality of petals are squeezed to deform to open the perforation as the multi-electrode catheter is passed through the perforation, and are repositioned to close the perforation after the multi-electrode catheter is withdrawn from the perforation.

Preferably, the block piece further comprises a sealing member disposed at one side of the flow blocking membrane, the sealing member being provided with a passage through which the multi-electrode catheter passes, the passage being closed after the multi-electrode catheter is withdrawn from the passage.

Preferably, the sealing member is made of a blood coagulation and flow resistance material having elasticity, and the passage is a slit.

Preferably, the passages of the seal are staggered with the perforations of the flow-blocking die.

Preferably, the seal is disposed in the interior cavity of the closure.

Preferably, a connector is arranged at the proximal end of the sealing part, a connecting hole for the multi-electrode catheter to pass through is axially arranged on the connector, and the sealing element is arranged in the connecting hole.

Preferably, the sealing element includes a slot ring connected to the connector, a rotating base rotatably disposed in the slot ring, a plurality of closing pieces slidably connected between the rotating base and the slot ring, and a rotating shaft connected to the rotating base, the channel is a through hole axially disposed between the slot ring and the rotating base and through which the multi-electrode catheter passes, the rotating shaft drives the rotating base to rotate relative to the slot ring, so that the closing pieces slide relative to the slot ring and the rotating base, and thus on a path of the through hole respectively formed by the slot ring and the rotating base, the closing pieces are respectively disposed and form a gap therebetween, the through holes respectively formed by the slot ring and the rotating base are communicated with each other, and the through hole is further opened; or the plurality of closing pieces are intensively arranged to form a barrier, and the through holes respectively formed by the clamping groove ring and the rotating base are mutually isolated through the plurality of closing pieces so as to close the through holes.

Preferably, the draw-in groove ring extends a plurality of extension strip to its inner chamber, and is a plurality of the closed piece is located a plurality of extend the strip with between the rotating base, rotating base is equipped with a plurality of guide chute, and one side sliding connection of each closed piece is in the guide chute that corresponds, and the opposite side that each closed piece is relative and the extension strip sliding connection that corresponds, rotating base for the draw-in groove ring rotates in order to drive a plurality of closed piece slides along the guide chute that corresponds and extends the strip.

Preferably, the closing mechanism further comprises a rotating cable and a handle, the handle is connected with the rotating cable to control the rotating cable to rotate, and the distal end of the rotating cable is connected with the rotating shaft through threads; in the process that the rotating steel cable rotates along the first direction, the rotating steel cable and the rotating shaft are gradually screwed; when the rotating steel cable and the rotating shaft are in a screwed state, and the rotating steel cable drives the rotating shaft to rotate along a first direction, the plurality of closing pieces respectively slide along the corresponding guide sliding grooves and the corresponding extending strips to open the through holes; when the handle controls the rotating steel cable to rotate along the second direction, the rotating steel cable drives the rotating shaft to rotate along the second direction, and the plurality of closing pieces respectively slide along the corresponding guide sliding grooves and the corresponding extending strips to close the through holes; and under the state that the through holes are closed by the closing pieces, the rotating steel cable and the rotating shaft are gradually loosened in the process that the rotating steel cable rotates along the second direction.

Preferably, the multi-electrode lead-in device further comprises an inner sheath tube detachably connected to the blocking piece, the multi-electrode lead-in device is arranged in the inner cavity of the inner sheath tube in a penetrating mode, the far end of the multi-electrode lead-in device is connected to the far end of the inner sheath tube, the far end of the inner sheath tube penetrates through the at least one flow blocking film and is inserted into the sealing portion, the anchoring portion or extends out of the far end of the blocking piece, and the multi-electrode lead-in device extends out of the far end of the inner sheath tube and is surrounded into a ring shape.

Preferably, the distal end of the inner sheath is fixedly attached to the distal end of the multi-electrode catheter.

The utility model provides a left auricle plugging device not only can the shutoff opening of left auricle to it is right to control to melt the piece target tissue region in the left auricle, and mark the piece and can mark the left auricle internal electric signal in order to ensure to form the ablation region of complete at least round near the opening of left auricle, thereby reaches complete electric isolation treatment.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural view of a left atrial appendage occlusion device provided in a first embodiment of the present invention;

figure 2 is a schematic structural view of a portion of a multi-electrode catheter and a portion of a sheath of the left atrial appendage occlusion device of figure 1;

figure 3 is a state diagram of the use of the left atrial appendage occlusion device of figure 1 to map electrical signals within the left atrial appendage;

FIG. 4 is a partial perspective view of the flow-blocking membrane and the inner sheath of the sealing portion according to an embodiment;

fig. 5 is a schematic structural view of a left atrial appendage occlusion device provided by a second embodiment of the present invention;

fig. 6 is a schematic structural view of a left atrial appendage occlusion device provided by a third embodiment of the present invention;

FIG. 7 is a schematic structural view of another embodiment of the seal of FIG. 6;

FIG. 8 is a schematic partially cross-sectional structural view of the multi-electrode catheter and inner sheath of the left atrial appendage occlusion device of FIG. 6;

fig. 9 is a schematic structural view of a left atrial appendage occlusion device provided by a fourth embodiment of the present invention;

fig. 10 is a schematic structural view of a multi-electrode catheter according to a fifth embodiment of the present invention;

fig. 11 is a schematic structural view of a multi-electrode catheter according to a sixth embodiment of the present invention;

FIG. 12 is a bottom view of the multi-electrode catheter of FIG. 11;

figure 13 is a cross-sectional view of a sealing member of a left atrial appendage occlusion device according to a seventh embodiment of the present invention;

FIG. 14 is a perspective view of the seal rotating base of FIG. 13 with one of the closure tabs;

FIG. 15 is a schematic view of one of the states of the seal of FIG. 13;

FIG. 16 is a schematic view of another condition of the seal of FIG. 13;

FIG. 17 is a cross-sectional view of the rotary shaft and the extended cartridge on the snap ring of the seal of FIG. 13.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

In the description of the present invention, the term "proximal end" refers to the end near the operator during the operation, and the term "distal end" refers to the end away from the operator during the operation. The axial direction refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis, and this definition is only for the convenience of expression and can not be understood as the limitation of the present invention. The term "connection of component A to component B" means that component A is directly connected in contact with component B or component A is indirectly connected to component B through another component.

Referring to fig. 1 to 3, the present invention provides a left atrial appendage occlusion device 100, which includes an occlusion piece 20, an ablation piece 30 connected to the occlusion piece 20, and a mapping piece 70, wherein the occlusion piece 20 is configured to be fixed at an opening of a left atrial appendage; the ablating member 30 is connected to an external source of ablation energy, the ablating member 30 being adapted to deliver ablation energy to ablate a target tissue region in the left atrial appendage; the mapping member 70 is connected to an external mapping signal receiver, and the mapping member 70 is used for receiving electrophysiological signals to map the target tissue region. In this embodiment, the ablation energy source is a high frequency pulse source. The occluding member 20 is disposed at the distal end of the left atrial appendage occluding device 100. it is understood that the left atrial appendage occluding device 100 further comprises a handle (not shown) disposed at the proximal end for controlling the ablation member 30 and the mapping member 70 to cooperate with each other for ablation and mapping, and an outer sheath (not shown) connected between the handle and the occluding member 20.

In this embodiment, the blocking member 20 is a hollow structure, specifically, the blocking member 20 is formed by cutting and shaping a nickel-titanium alloy tube, and the blocking member 20 is in a top hat shape in a completely released state; the left atrial appendage occlusion device 100 further includes a multi-electrode catheter 40 releasably connected to the occlusion member 20, the multi-electrode catheter 40 including a distal section 42 at a distal end thereof, the ablating member 30 and the mapping member 70 being disposed on the distal section 42 of the multi-electrode catheter 40, the distal section 42 being receivable within the occlusion member 20 or extendable beyond the distal end of the occlusion member 20, i.e., the distal section 42 being capable of extending from the distal end of the occlusion member 20, wherein the distal end of the occlusion member 20 is closer to the handle than the distal section 42, and the mapping member 70 on the distal section 42 contacts the target tissue to receive the electrophysiological signals.

The utility model discloses left auricle plugging device 100's shutoff piece 20 is used for fixing at left auricle opening part to the opening of shutoff left auricle, it melts to melt piece 30 and is used for transmitting the target tissue region of melting energy in order to the left auricle, and mark piece 70 is used for receiving electrophysiological signal and marks the mark with regional mark to the target tissue. Thus, the left atrial appendage occlusion device 100 can not only occlude the opening of the left atrial appendage and control the ablation member 30 to ablate a target tissue region in the left atrial appendage, but the mapping member 70 can map the electrical signal in the left atrial appendage to ensure that a complete at least one turn of the ablation region is formed near the opening of the left atrial appendage to achieve a complete electrical isolation treatment.

As shown in fig. 1, the blocking member 20 comprises a self-expanding support skeleton, in particular, the blocking member 20 may comprise an elastic metal support skeleton or an elastic non-metal support skeleton, and optionally, the blocking member 20 further comprises a blocking member disposed on the support skeleton. In this embodiment, the blocking member 20 comprises a metal cutting stent with elasticity, and preferably, the blocking member 20 is a stent formed by cutting a nickel-titanium alloy tube. The outer sheath is connected between the handle and the blocking piece 20 in a hollow tubular shape, and when the left atrial appendage blocking device 100 delivers the blocking piece 20 through the outer sheath, the diameter of the blocking piece 20 can be contracted to a smaller state so as to be delivered in the outer sheath; when the occluding member 20 extends from the distal end of the outer sheath and is released near the opening of the left atrial appendage, the occluding member 20 may automatically expand such that the outer wall of the occluding member 20 is fully attached to the inner wall of the opening of the left atrial appendage.

In this embodiment, the blocking piece 20 is a hollow structure after being released in vivo, in this embodiment, the blocking piece 20 is formed by cutting a tube, the blocking piece 20 may also be formed by weaving wires, or may be processed by combining local weaving with local tube cutting, and different parts may be welded or fixed to each other by a connecting member. The material of the tubular product is metal or nonmetal material, preferably memory metal material, such as nickel-titanium alloy material. The overall shape of the block piece 20 may be any suitable shape such as a cylindrical shape, a disk shape, a tapered shape, etc., and is not limited herein.

In the present embodiment, the sealing member 20 includes an anchoring portion 22 and a sealing portion 24 connected to a proximal end of the anchoring portion 22, the anchoring portion 22 and the sealing portion 24 are an integral grid-shaped supporting skeleton cut from a single nitinol tube, and in a modified embodiment, the anchoring portion 22 and the sealing portion 24 are each cut from a single nitinol tube and connected by a connecting member. A multi-electrode catheter 40 detachably connected to the proximal end of the sealing portion 24; the distal section 42 of the multi-electrode catheter 40 is received within the lumen of the sealing portion 24, the lumen of the anchoring portion 22, or extends out of the distal end of the anchoring portion 22; the distal section 42 is pre-shaped in at least one annular structure, i.e., the distal section 42 forms at least one ring around the circumference of the occluding member 20. The radial dimension of the sealing portion 24 is greater than the radial dimension of the anchoring portion 22.

The far end of the anchoring part 22 is turned outwards to be hemispherical, specifically, the anchoring part 22 comprises a plurality of connecting rods 221 which are positioned in the middle of the anchoring part 22 and are arranged in a circle in the circumferential direction, an anchoring frame 223 connected to the far end of the connecting rods 221, and an inward-folded frame 227 connected to the near end of the anchoring frame 223; the distal end of each connecting rod 221 is turned outward in a circular arc shape, and the proximal end of each connecting rod 221 is connected to the seal portion 24.

The anchoring frame 223 is used for abutting against the inner wall at the opening of the left atrial appendage for a circle, so that the whole plugging piece 20 can be fixed at the opening of the left atrial appendage and is not easy to loosen. While anchor frame 223 is in the form of a grid and forms a plurality of hexagonal cells arranged circumferentially around anchor portion 22, it will be appreciated that anchor frame 223 may also form cells of other shapes, such as square, diamond, strip, or other irregular shapes, in alternative embodiments. Further, the anchor frame 223 includes distal wave-shaped anchor rings 2231 connected to distal ends of the connecting rods 221, several connecting bars 2233 connected to troughs of the distal wave-shaped anchor rings 2231, and proximal wave-shaped anchor rings 2235 connected to proximal ends of the connecting bars 2233; that is, the wave crests of the distal wave-shaped anchor rings 2231 are connected to the distal ends of the corresponding connecting rods 221, the wave troughs of the distal wave-shaped anchor rings 2231 are connected to the distal ends of the corresponding connecting bars 2233, the wave crests of the proximal wave-shaped anchor rings 2235 are connected to the proximal ends of the corresponding connecting bars 2233, and the wave troughs of the proximal wave-shaped anchor rings 2235 are connected to the inside folding frame 227. That is, a plurality of hexagonal mesh holes surrounded by the anchoring frame 223 are formed between the distal wave-shaped anchoring ring 2231 and the proximal wave-shaped anchoring ring 2235, and adjacent hexagonal mesh holes are spaced by the connecting bars 2233.

The invagination frame 227 includes invagination rods 2271 that are folded from each valley of the proximal wave-shaped anchoring ring 2235 toward the interior of the anchoring frame 223, with each adjacent two invagination rods 2271 being gathered together away from the ends of the corresponding valleys of the proximal wave-shaped anchoring ring 2235.

The outer surface of anchoring portion 22 is equipped with a plurality of barbs 2236, and a plurality of barbs 2236 set up at least one circle along anchoring portion 22's circumference. Because the outer surface of anchoring portion 22 sets up barb 2236, when the closure member 20 was implanted in the inner chamber of the left atrial appendage, barb 2236 can pierce the inner wall of the left atrial appendage so that the entire closure device 100 can be tightly fitted in the left atrial appendage without falling off, making things convenient for the recovery of multi-electrode catheter 40 simultaneously. Specifically, the barbs 2236 are provided on the outer wall of the connecting bar 2233, and these barbs 2236 are provided once in the circumferential direction of the anchoring portion 22. Preferably, the number of at least one loop of barbs 2236 is between 8 and 16. In this embodiment, each connecting bar 2233 has barbs 2236 on its outer wall.

In other embodiments, the outer wall of distal wave anchor ring 2231 and/or proximal wave anchor ring 2235 is provided with at least one ring of barbs 2236; preferably, a barb 2236 extends outwardly at each trough and/or each peak of the distal wave pattern anchoring ring 2231, and/or a barb 2236 extends outwardly at each trough and/or each peak of the proximal wave pattern anchoring ring 2235.

The sealing portion 24 is in a yurt-shaped net structure in a completely released state, a distal end of the sealing portion 24 extends to an inner cavity of the anchoring portion 22 and is connected to proximal ends of the plurality of connecting rods 221, the proximal ends of the sealing portion 24 are connected to a connector 240 after being converged at a middle portion thereof, and the connector 240 is provided with a through hole 242 through which the multi-electrode catheter 40 is inserted in an axial direction.

In other embodiments, the occluding member 20 need only be hollow in the middle and have a passage for the multi-electrode catheter 40 to pass through, so that the distal section 42 of the multi-electrode catheter 40 can pass through the middle of the occluding member 20 to reach the left atrial appendage for ablation.

The multi-electrode catheter 40 is in a long tubular shape and made of an elastic material, and the distal end section 42 thereof is pre-shaped into an annular structure, i.e. in a natural state, the distal end section 42 is in an annular shape, the distal end section 42 can be elastically deformed under the action of external force, and after the external force is removed, the distal end section 42 returns to the pre-shaped annular shape. Accordingly, the left atrial appendage occlusion device 100 further comprises an inner sheath 60 in the form of a long tube for receiving the multi-electrode catheter 40, the multi-electrode catheter 40 is pre-installed in the inner sheath 60, the distal segment 42 is linearly received in the inner sheath 60 in the delivery state, the released portion of the distal segment 42 from the inner sheath 60 returns to the pre-set shape, and the distal segment 42 returns to the pre-set annular shape after the distal segment 42 is completely released from the inner sheath 60. The multiple-electrode catheter 40 includes a carrier member 41 having a tubular shape made of an elastic insulating material, the main body of the multiple-electrode catheter 40 being the carrier member 41, and the distal end of the carrier member 41 being pre-shaped into a distal end section 42. The carrier member 41, the distal end of the carrier member 41 is provided with a distal end section 42, and the distal end section 42 is pre-shaped in at least one ring shape.

As shown in fig. 2, the ablating member 30 is a plurality of ablating electrodes disposed on the distal end section 42, and the mapping member 70 is a plurality of mapping electrodes disposed on the distal end section 42. The distal segment 42 is pre-shaped in a ring shape to facilitate the formation of a uniform strength annular pulsed electric field by the ablation electrode to electrically isolate tissue cells near the ostium of the left atrial appendage and form a complete circumferential annular ablation zone on the luminal peripheral wall of the left atrial appendage.

Specifically, a plurality of ablation electrodes and a plurality of mapping electrodes are arranged at intervals in the distal end section 42, that is, each ablation electrode and each mapping electrode are arranged on the outer surface of the distal end section 42, adjacent ablation electrodes and ablation electrodes, adjacent ablation electrodes and mapping electrodes, and adjacent mapping electrodes and mapping electrodes are arranged at intervals, and gaps are formed therebetween to insulate each other.

In this embodiment, the ablation electrodes and the mapping electrodes are staggered, that is, at least one mapping electrode is disposed between two adjacent ablation electrodes, and at least one ablation electrode is disposed between two adjacent mapping electrodes. In other embodiments, the ablation electrodes and the mapping electrodes are not limited to be staggered with respect to each other. Preferably, the plurality of distal end segments 42 have a uniform spacing of the plurality of distal end segments 42 in the axial direction, and the plurality of mapping electrodes are uniformly spaced in the axial direction of the distal end segments 42.

As shown in fig. 2, the multi-electrode lead 40 further includes a lead 43 provided to the carrier member 41. The ablation electrode and the mapping electrode are electrically connected to an external ablation energy source and a mapping signal receiver through wires 43, respectively, that is, a part of the wires 43 are connected between the ablation electrode and the external ablation energy source. In this embodiment, different ablation electrodes are connected to different conducting wires 43, and in a modified embodiment, one conducting wire 43 can be shared by one ablation electrode group, that is, at least some ablation electrodes are connected to the same conducting wire 43. Another portion of the lead wires 43 is connected between the mapping electrodes and an external mapping signal receiver, in this embodiment, different mapping electrodes are used to connect to different lead wires 43, and in a modified embodiment, one lead wire 43 may be shared by a set of mapping electrodes, i.e., at least some of the mapping electrodes are connected to the same lead wire 43. In other embodiments, the ablation electrodes on the distal section 42 may be connected in series by one wire 43, and the mapping electrodes on the distal section 42 may also be connected in series by one wire.

In this embodiment, the conducting wire 43 is accommodated in the inner cavity of the carrier 41, and two ends of the conducting wire 43 are respectively connected to the ablation electrode and the external ablation energy source, or two ends of the conducting wire 43 are respectively connected to the mapping electrode and the external mapping signal receiver. In a modified embodiment, the wires 43 are embedded in the wall of the support member 41 and extend in the axial direction, and connect the corresponding electrodes with external equipment. In the modified embodiment, the leads 43 are disposed on the outer surface of the carrier member 41, extend along the surface of the carrier member 41, and connect the corresponding electrodes with external devices.

The distal segment 42 can be received through the flow barrier membrane 50 into the lumen of the sealing portion 24, the lumen of the anchoring portion 22, or extend beyond the distal end of the anchoring portion 22 such that the ablating member 50 and the mapping member 70 on the distal segment 42 are received into the lumen of the occluding member 20 or exposed out of the distal end of the occluding member 20. When the multi-electrode catheter 40 is received within the inner lumen of the sealing portion 24 or the inner lumen of the anchoring portion 22, the ablating member 50 facilitates ablation of a target tissue region in the left atrial appendage; when the multi-electrode catheter 40 extends out of the distal end of the anchoring portion 22, the mapping member 70 is brought into contact with the target tissue to receive electrophysiological signals. It will be appreciated that in a modified embodiment, the multi-electrode catheter 40 is adapted to extend beyond the distal end of the anchor portion 22 to ablate the target tissue region.

In this embodiment, as shown in fig. 1, at least one blocking member is disposed in the sealing portion 24, and the blocking member is used to prevent thrombus in the left atrial appendage from entering the atrium.

The barrier may be a flow-blocking membrane or other element for blocking thrombus. The barrier does not allow thrombus to pass through, but allows little or neither blood flow. The barrier may have a plurality of openings, which may be made permeable by the aperture ratio and/or the pore size, i.e. may block thrombus by blood flow. The surface of the barrier may also be plated or coated with an anticoagulant (e.g., heparin) or other compound, or the surface of the barrier may also be treated to impart antithrombin properties.

For a barrier with open pores, the pore size may range from 65 to 1000 microns, it being understood that the pore size may also be slightly larger than 1000 microns or slightly smaller than 65 microns, as long as it prevents the passage of thrombus, for example, it may be 65 to 400 microns specifically. The aperture ratio of the barrier means the percentage of the entire area of the barrier that is occupied by the aperture area, and the aperture ratio of the barrier is at least 20%, specifically, any one of 25% to 60%, and can be set as needed. The barrier may be a two-dimensional screen, a porous membrane, a woven or non-woven mesh, or similar structure. The barrier may be a metal with the above-mentioned infiltration function or a metal mesh with fine fibers, or may be made of a biocompatible material, such as ePFTE (for example), polyester (for example), PTFE (for example), silicone, urethane, metal fibers, or other biocompatible polymers, which will not be described in detail herein.

In this embodiment, the blocking member is a flow blocking membrane 50, the flow blocking membrane 50 is connected to the supporting framework of the block 20 by suture or hot pressing, and the flow blocking membrane 50 is used to prevent thrombus in the left atrial appendage from entering into the atrium, and restrain the block 20 to make it difficult to deform and enhance the structural stability. The flow-blocking membrane 50 is sealed at the opening of the left atrial appendage, specifically, is disposed at the proximal end of the inner cavity of the sealing portion 24, and provides a sufficient release space for the multi-electrode catheter 40 in the sealing portion 24. In the modified embodiment, the barrier is provided in the inner cavities of the seal portion 24 and the anchor portion 22, or in the inner cavity of the anchor portion 22. It can be understood that the outer surface of the sealing portion 24 and/or the anchoring portion 22 is further provided with a blocking member, so that the direct contact area between the supporting framework and the left atrial appendage tissue is reduced, the pressure of the supporting framework on the left atrial appendage tissue is reduced, the left atrial appendage tissue is stressed more uniformly, and a certain protection effect on the tissue is achieved. In the present embodiment, the flow blocking film 50 is also formed with a perforation through which the multi-electrode catheter 40 passes.

The specific operation method of the left atrial appendage occlusion device 100 provided in this embodiment is as follows.

The multi-electrode catheter 40 is pre-installed in the inner sheath tube 60, the inner sheath tube and the blocking piece 20 are pre-installed in the outer sheath tube of the left atrial appendage blocking device 100 and are conveyed together, the blocking piece 20 is released at the position of the opening of the left atrial appendage, the multi-electrode catheter 40 is accommodated in the inner sheath tube 60 and is pushed forward together with the inner sheath tube 60, the multi-electrode catheter 40 sequentially penetrates through the through hole 242 of the connector 240 and the through-flow resistance membrane 50 in the sealing part 24, the opening at the far end of the inner sheath tube 60 is positioned in the space between the through-flow resistance membrane 50 and the far end of the sealing part 24, the multi-electrode catheter 40 is released from the inner sheath tube 60, the multi-electrode catheter 40 is restored to be annular in the sealing part 24, and the ablation piece 30 is connected with an external ablation energy source and then transmits energy to tissues so as to ablate a target tissue region in the left atrial appendage; after ablation, withdrawing and retracting the distal end section 42 of the multi-electrode catheter 40 into the inner sheath tube 60, pushing the inner sheath tube 60 distally to make the distal end of the inner sheath tube 60 extend out of the distal end of the plugging piece 20, wherein the distal end section 42 extends out of the distal end of the inner sheath tube 60, so that the mapping piece 70 contacts the target tissue on the inner wall of the left atrial appendage to acquire electrophysiological signals in the target tissue region to realize mapping; if the ablation is not complete according to the received electrophysiological signals, the electrical isolation effect is not achieved, the distal end section 42 needs to be accommodated in the inner cavity of the blocking piece 20 to continue ablation, the distal end section 42 extends out of the distal end of the blocking piece 20 to enable the electrical mapping piece 70 to collect the electrophysiological signals in the target tissue region until the ablation is determined to be completed according to the received electrophysiological signals, the multi-electrode catheter 40 is retracted into the inner sheath tube 60, and the inner sheath tube 60 is retracted, so that the inner sheath tube 60 is separated from the proximal end of the blocking piece 20 from the blocking piece 20 after passing through the flow-resistant film 50 and the through hole 242.

In this embodiment, the ablation energy provided by the external ablation source is a high-voltage pulse energy, and compared with other energy, the pulse ablation does not require heat conduction to ablate deep tissues, and all tissue cells distributed above a certain electric field intensity are subjected to irreversible electroporation, thereby reducing the requirement that the distal section 42 of the multi-electrode catheter 40 is attached to the tissues during ablation. Therefore, even if the ablation member 30 does not completely conform to the inner wall of the left atrial appendage after entering the left atrial appendage, the ablation effect of the irreversible electroporation is not affected.

In other embodiments, the ablative energy source can be any of a radiofrequency energy source, a microwave energy source, or the like. The distal section 42 of the multi-electrode catheter 40 is not limited to a circular deformation.

As shown in fig. 4, in one embodiment, the flow blocking film 50 is provided with a perforation 52 for the multi-electrode catheter 40 and the inner sheath 60 to pass through, a split structure design is adopted around the perforation 52, specifically, the flow blocking film 50 has elasticity, the flow blocking film 50 comprises a plurality of split valves 54 arranged around the perforation 52 and extending towards the perforation 52, a gap is arranged between the adjacent split valves 54, and the perforation 52 for the multi-electrode catheter 40 to pass through is formed between the plurality of split valves 54; when the multi-electrode catheter 40 passes through the perforation 52, the plurality of sub-valves 54 are extruded and elastically deformed to open the perforation 52, so that the multi-electrode catheter 40 and the inner sheath tube 60 can be conveniently inserted; after the multi-electrode catheter 40 and the inner sheath 60 are withdrawn proximally from the puncture 52, the partial valves 54 are elastically restored to re-close the puncture 52 to block thrombus or blood flow.

In other embodiments, at least one circle of developing points or developing wires is circumferentially disposed on the outer surface of the sealing member 20, and specifically, several developing points are circumferentially disposed on the outer surface of the anchoring portion 22 and/or the sealing portion 24, and the several developing points form at least one circle along the circumferential direction of the sealing member 20. The developing points are fixed in modes of inlaying, hot pressing and the like; the developing wire is fixed by winding, inlaying, hot pressing and the like. The developing points and the developing wires can be made of materials such as gold, platinum, tantalum and the like.

Referring to fig. 5, the structure of the left atrial appendage occlusion device 100a provided in the second embodiment of the present invention is similar to that of the first embodiment, except that the ablating member of the second embodiment is disposed on the occlusion member 20, and preferably, the ablating member is disposed at least one turn along the circumferential direction of the outer wall of the occlusion member 20. The ablation member is disposed on the outer wall of the anchoring portion 22 and/or the sealing portion 24 of the blocking member 20 and is disposed at least one circle along the circumferential direction, in this embodiment, the ablation member is disposed on the surface of the anchoring portion 22 for one circle. The method comprises the following specific steps:

the blocking member 20 in the second embodiment is a conductive bare metal stent, the outer surface of the blocking member 20 includes an insulating region and a conductive region, the surface of the insulating region is completely insulated, for example, an insulating coating is coated, the surface of the conductive region is not insulated and can conduct an electrical signal, the blocking member 20 in the conductive region is used as an ablation member 33, the connector 240 at the proximal end of the blocking member 20 is connected with an external ablation energy source, the ablation energy is transmitted to the ablation member 33 through the blocking member 20, so as to perform radio frequency ablation on left atrial appendage tissue attached to the ablation electrode 33, and thus complete annular ablation is formed on the inner cavity peripheral wall of the left atrial appendage.

In this embodiment, the distal section 42 of the release multi-electrode catheter 40 is distal to the occluding device 20, and electrophysiological signals within the left atrial appendage are mapped by the mapping device 70 on the distal section 42. After the ablation is finished, the mapping component 70 is removed from the body along with the multi-electrode catheter 60, and the ablation component 33 and the plugging component 20 are left in the body as an integral structure, i.e. the mapping component 70 is detachably connected to the plugging component 20. In a modified embodiment, the ablation member 30 is disposed on the multi-electrode catheter, the mapping member 70 is disposed on the occluding member 20, and the ablation member 30 is releasably attached to the occluding member 20.

The plugging member 20 in this embodiment is made of a conductive material, and a part of the supporting framework of the plugging member 20 is directly used as an ablation member; preferably, a circle of ablation pieces 33 is arranged on the outer peripheral surface of the blocking piece 20 at the position with the largest radial dimension, namely, insulation treatment is carried out on the other parts of the whole blocking piece 20 except for the partial area of the ablation pieces 33, the ablation pieces 33 are the parts of the surface of the metal supporting framework which are not subjected to insulation treatment, and at least one circle of electrical exposed areas of the blocking piece 20 are electrically exposed; in other embodiments, the outer circumferential surface of the anchoring portion 22 and/or the outer circumferential surface of the sealing portion 24 is provided with at least one ring of ablating members 33; specifically, at least one circle of ablation electrodes 33 is disposed on one of the outer peripheral surface of the distal wave-shaped anchoring ring 2231, the outer peripheral surfaces of the connecting bars 2233, and the outer peripheral surface of the proximal wave-shaped anchoring ring 2235, that is, the outer surface of the distal wave-shaped anchoring ring 2231, the outer surfaces of the connecting bars 2233, and the surface of the proximal wave-shaped anchoring ring 2235 are insulated except for the ablation electrodes 33, or the outer surface of the sealing portion 24 is insulated except for the ablation electrodes 33. The insulation treatment of the outer surface of the blocking piece 20 except the ablation electrode 33 can prevent the rest of the outer surface from contacting blood for conduction, reduce impedance and cause that complete annular ablation on the inner wall of the left atrial appendage cannot be finished.

The insulation treatment may be plating an insulation coating on the outer surface of the support frame of the plugging member 20 or sleeving an insulation sleeve on the support frame. Further, the insulating coating is a parylene insulating coating, and the insulating sleeve can be FEP or ETFE or PFA or PTFE sleeve. Because the occluding member 20 is itself electrically conductive, the delivery of ablative energy to the ablating member 33 is energized, further concentrating the energy on the tissue adjacent to the ablating member 33.

In other embodiments, the ablation member 33 may be an ablation electrode, such as a wire electrode, an electrode sheet or a ring electrode, disposed on the supporting framework of the occlusion member 20, the ablation electrode is electrically connected to the ablation energy source through an external power connection line, and the supporting framework is insulated at a position in contact with the ablation electrode, such as coated with an insulating layer or wrapped with an insulating film or an insulating sleeve, in order to concentrate the ablation energy on the ablation electrode.

In other embodiments, the supporting framework of the occlusion element 20 may also be made of a supporting frame made of non-conductive material, and the ablation element 33 is at least one continuous or discontinuous circle circumferentially arranged along the outer surface of the supporting framework; or the ablation part 33 is a plurality of point-like electrodes or strip-like electrodes, and the plurality of point-like electrodes or strip-like electrodes are arranged at least one circle along the circumferential direction of the outer wall surface of the occlusion part 20.

In other embodiments, the ablation electrode 33 is a continuous single or multiple turns of wire electrode circumferentially disposed along the support frame of the occluding member 20; the electrode wire is connected to the supporting framework through winding, welding or pressing; and the outer surface of the supporting framework is subjected to insulation treatment in a mode that an insulation coating is coated on the outer surface of the supporting framework, or an insulation sleeve is sleeved on the supporting framework, or an insulation film is coated on the supporting framework. The insulating coating is at least one insulating material selected from FEP, ETFE, PFA and PTFE; the insulating sleeve is at least one insulating tube selected from FEP, ETFE, PFA, PTFE and silica gel; the insulating film is at least one insulating film selected from FEP, ETFE, PFA, PTFE and silicone rubber. The insulating coating is connected with the supporting framework of the plugging piece 20 in a sewing, hot pressing, spraying or dipping mode.

In other embodiments, at least one ring of ablation electrodes 33 is disposed on two of the outer peripheral surface of the distal wave-shaped anchoring ring 2231, the outer peripheral surfaces of the connecting bars 2233, and the outer peripheral surface of the proximal wave-shaped anchoring ring 2235. Alternatively, at least one ring of ablating members 33 is disposed on the outer peripheral surface of the distal wave-shaped anchoring ring 2231, the outer peripheral surfaces of the plurality of connecting rods 2233, and the outer peripheral surface of the proximal wave-shaped anchoring ring 2235.

In this embodiment, the ablation energy source is a radio frequency signal, and the radio frequency signals connected to the plurality of ablation elements 33 are the same, and in the modified embodiment, the ablation energy source is a pulse or a microwave, and the plurality of ablation elements 33 can be flexibly set as needed.

Referring to fig. 6, a left atrial appendage occlusion device 100b according to a third embodiment of the present invention has a structure similar to that of the first embodiment, except that a supporting framework of an occlusion element 20a in the third embodiment is different from that of the occlusion element 20 in the first embodiment, and the occlusion element 20a further includes a sealing element 80, the sealing element 80 is accommodated in an inner cavity of the occlusion element 20a, further, the sealing element 80 is disposed on one side of the current-blocking membrane 50, the sealing element 80 is provided with a channel for the multi-electrode catheter 40 to pass through, and after the multi-electrode catheter 40 is withdrawn from the channel of the sealing element 50, the channel of the sealing element 80 is closed. Specifically, the method comprises the following steps:

the blocking piece 20a is of a hollow structure, the blocking piece 20a comprises an anchoring part 22 and a sealing part 24, the anchoring part 22 is arranged at the far end relative to the sealing degree 24, and the anchoring part 22 and the sealing part 24 are integrated latticed supporting frameworks woven by nickel-titanium alloy metal wires; the occluding member 20a has a barrel-like configuration in a fully released state, and the anchoring portion 22 is provided with an opening toward the distal end. In a modified embodiment, the anchoring portion 22 is braided toward the distal end to form a base through which the multi-electrode catheter 40 protrudes from the distal end of the occluding member 20. In addition, the peripheral surface of the anchoring portion 22 is provided with a circumferential barb 2236 to ensure that the blocking member 20a is stably anchored to the inner cavity of the left atrial appendage.

The sealing member 80 is made of a blood-clotting and flow-blocking material having elasticity, and the passage of the sealing member 80 is closed after the multi-electrode catheter 40 is withdrawn, and blood cannot pass through the barrier formed by the sealing member 80 and the flow-blocking membrane 50. That is, the sealing member 80 is used to close the connection hole 242 of the connection head 240 and the through hole or the slit of the flow blocking film 50. Preferably, the sealing member 80 is disposed on the choke membrane 50 side of the inner cavity of the sealing portion 24, in the present embodiment, the sealing member 80 and the choke membrane 50 are adjacent to each other, and in the modified embodiment, the sealing member 80 and the choke membrane 50 are disposed at a distance.

In this embodiment, the sealing member 80 is a circular hemostatic sponge with hemostatic agent dispersed therein, the hemostatic sponge is fixed at the proximal end of the inner cavity of the sealing portion 24 and has a passage for the multi-electrode catheter 40 to pass through, and the passage is a slit; the passage of the sealing element 80 is staggered with the perforation of the flow blocking film 50, i.e. the gap of the hemostatic sponge is staggered with the perforation of the flow blocking film 50, so as to prevent the blood flow or blood clots and other substances from flowing out of the left atrial appendage to the left atrium through the perforation of the flow blocking film 50 and the gap of the sealing element 80.

The flow blocking film 50 in the present embodiment may be any type of barrier described above.

The distal section of the multi-electrode catheter is pre-shaped into a plurality of annular structures arranged in an axial direction. The distal section 42 of the multi-electrode catheter 40 is pre-shaped in a plurality of annular structures arranged in an axial direction, with the diameters of the annular structures being smaller closer to the distal end. In this embodiment, the multi-electrode catheter 40 is pre-shaped in a two-turn ring configuration, with the diameter of the distal ring configuration being smaller than the diameter of the proximal ring configuration; specifically, the multi-electrode catheter 40 includes a proximal loop 421 and a distal loop 423; the proximal ring 421 has a larger diameter than the distal ring 423. When the multi-electrode catheter 40 enters the left atrial appendage for ablation, the proximal end ring 421 and the distal end ring 423 can be arranged in a spiral shape, so that a better annular ablation effect is achieved.

The multi-electrode catheter 40 is provided with an ablation part 30 and a mapping part 70, the ablation part 30 is an ablation electrode sleeved on the carrier part 41 of the multi-electrode catheter 40, the mapping part 70 is a mapping electrode sleeved on the carrier part 41 of the multi-electrode catheter 40, both the ablation electrode and the mapping electrode can be ring electrodes, the ablation electrode is used for transmitting ablation energy, and the mapping electrode is used for detecting electrical signals. The multi-electrode catheter 40 is provided with a plurality of ablation electrodes and a plurality of mapping electrodes along the length direction thereof, in this embodiment, the ablation electrodes and the mapping electrodes are arranged in an interlaced manner, or may be arranged in a layered manner, that is, the mapping component 70 is disposed on the distal end ring 423, and the ablation component 30 is disposed on the proximal end ring 421. In this embodiment, the ablation electrode rings and the mapping electrode rings are alternately staggered along the extending direction of the carrier 41.

In other embodiments, a ring of ablation electrodes is provided on the proximal ring 421 of the multi-electrode catheter 40, and a ring of mapping electrodes is provided on the distal ring 423 of the multi-electrode catheter 40; alternatively, a ring of mapping electrodes is provided on the proximal ring 421 of the multi-electrode catheter 40 and a ring of ablating electrodes is provided on the distal ring 423 of the multi-electrode catheter 40.

As shown in fig. 7, in one embodiment, the sealing member 80 is disposed in the connection hole 242 of the connection head 240. Specifically, the inner wall subsides of connecting hole 242 of connector 240 are equipped with the blood coagulation choked flow material that can swell, the blood coagulation choked flow material is fixed in the connector 240 inner chamber to be full of the inner chamber of connector 240, the centre of sealing member 80 is equipped with gap 82 and supplies interior sheath pipe 60 axial to alternate, and interior sheath pipe 60 is withdrawn from behind the connecting hole 242 of connector 240, but the gap 82 elasticity closure of blood coagulation choked flow material to prevent that substances such as blood stream, clot from flowing to the left atrium from the left atrial appendage.

In one embodiment, as shown in figure 8, the left atrial appendage occlusion device 100b includes an inner sheath 60 releasably coupled to the occlusion member 20, a multi-electrode catheter 40 disposed within the inner lumen of the inner sheath 60, and a distal end of the multi-electrode catheter 40 coupled to the distal end of the inner sheath 60. Specifically, the distal end of the multi-electrode catheter 40 is fixed to the distal end of the inner sheath 60 by means of bonding or welding. In this embodiment, the distal end of the multi-electrode catheter 40 is welded to the distal outer surface of the head of the inner sheath 60. When the inner sheath tube 60 reaches the ablation designated position, the multi-electrode catheter 40 is pushed out, so that the far end is prevented from being wound on the plugging piece 20 and other parts of the multi-electrode catheter 40 or target tissues when the multi-electrode catheter 40 is released, and the smooth sheathing of the multi-electrode catheter 40 is ensured to be annularly deformed. The distal end of the multi-electrode catheter 40 is fixed to the inner sheath tube 60, so that the tip end of the multi-electrode catheter 40 is restricted when it is restored to a ring shape, and accurate release of the multi-electrode catheter 40 at a designated area is also facilitated.

Referring to fig. 9, a left atrial appendage occlusion device 100c according to a fourth embodiment of the present invention is similar in structure to the third embodiment, except that the sealing element 80 of the fourth embodiment occupies a larger volume of the inner cavity of the occlusion piece 20a than the sealing element 80 of the third embodiment. Specifically, the method comprises the following steps: the sealing member 80 is a swellable blood-clotting and flow-blocking material disposed in the inner cavities of the sealing portion 24 and the anchoring portion 22, and the sealing member 80 is used to close the blocking member 20a after the multi-electrode catheter 40 is withdrawn, i.e., the sealing member 80 is used to close the connection hole 242 of the connection head 240 and the perforation in the flow-blocking membrane 50. Preferably, the clot-resistant material fills the lumens of the sealing portion 24 and the anchoring portion 22. In this embodiment, the blood coagulation and flow blocking material is a circular hemostatic sponge dispersed with hemostatic agent, and has a gap for the multi-electrode catheter 40 to pass through, the gap of the hemostatic sponge and the perforation of the flow blocking membrane 50 are arranged in a staggered manner, and after the multi-electrode catheter 40 is withdrawn, the hemostatic sponge and the flow blocking membrane 50 are in superposition fit, so as to prevent substances such as blood flow and blood clots from flowing out of the left atrial appendage to the left atrium.

Referring to fig. 10, fig. 10 is a schematic structural view of a multi-electrode catheter 40a of a left atrial appendage occlusion device according to a fifth embodiment of the present invention. The structure of the multi-electrode conduit 40a provided in the fifth embodiment of the present invention is different from that of the first embodiment, and the multi-electrode conduit 40a in the fifth embodiment includes a plurality of carrier bars 45 arranged sequentially in the circumferential direction, that is, the multi-electrode conduit 40a is a frame structure formed by surrounding the plurality of carrier bars 45 in the circumferential direction; the distal ends and the proximal ends of the plurality of support rods 45 are respectively combined together to form a lantern shape.

Specifically, the distal ends of the plurality of carrier rods 45 are connected to the distal end block 47 in a converging manner, the proximal ends of the plurality of carrier rods 45 are connected to a connecting block 46 in a converging manner, the middle portion of each carrier rod 45 is outwardly bent and protruded, and the distal end block 47 and the connecting block 46 can be retracted into the lumen of the inner sheath tube 60. By adjusting the axial distance between the distal block 47 and the connection block 46, the maximum diameter surrounded by the plurality of carrier bars 45 of the multi-electrode catheter 40b is adjusted, and the adherence of the multi-electrode catheter 40b to the inner wall of the left atrial appendage is improved, so that the multi-electrode catheter is suitable for left atrial appendage tissues with different morphological structures and different sizes.

The ablation member 30 is an ablation electrode circumferentially disposed on the plurality of support rods 45 in at least one turn, and the mapping member 70 is a mapping electrode circumferentially disposed on the plurality of support rods 45 in at least one turn. The distal surface of the distal block 47 is spherical to prevent the multi-electrode catheter 40a from damaging the left atrial appendage tissue.

Preferably, on the multi-electrode catheter 40a, the mapping electrodes are disposed proximally distally relative to the ablation electrodes, i.e., each ablation electrode is disposed proximally to the middle of the corresponding carrier rod 45, and each mapping electrode is disposed distally relative to the ablation electrode proximal carrier rod 45.

The plurality of carrier bars 45 of the multi-electrode catheter 40a are arranged in sequence in the circumferential direction, and in this embodiment, the plurality of carrier bars 45 are uniformly arranged in the circumferential direction of the distal end block 47; the multi-electrode catheter 40a has 3 to 8 carrier rods 45, and in the present embodiment, the multi-electrode catheter 40a has 6 carrier rods 45.

Referring to fig. 11 and 12 together, a multi-electrode catheter 40b according to a sixth embodiment of the present invention is similar to the multi-electrode catheter 40a of the fifth embodiment, except that each of the support rods 45 extends helically around the axial direction, and the mapping element 70 on the multi-electrode catheter 40b is adjacent to the distal end of the multi-electrode catheter 40b relative to the ablating element 30.

Specifically, the method comprises the following steps: the proximal and distal ends of each carrier rod 45 are circumferentially offset by a predetermined angle, preferably between 30 and 70 degrees. That is, the multi-electrode catheter 40b has a multi-rod helical structure in the radial direction, as shown in fig. 11. With the closer distance between the distal block 47 and the connection block 46, the support rod 45 of the multi-electrode catheter 40b is pressed to elastically deform into a flat shape like a petal, so that the ablation electrodes and the mapping electrodes are more uniformly distributed in the circumferential direction of the multi-electrode catheter 40 b. By adjusting the axial distance between the distal block 47 and the connection block 46, the maximum diameter enclosed by the plurality of support rods 45 of the multi-electrode catheter 40b is adjusted, which improves the adherence of the multi-electrode catheter 40b to the inner wall of the left atrial appendage, making it suitable for left atrial appendage tissues of different morphological structures and different sizes, and as shown in fig. 12.

Referring to fig. 13 to 17, the structure of the left atrial appendage occlusion device provided in the seventh embodiment of the present invention is similar to that of the first embodiment, except that the sealing element of the left atrial appendage occlusion device in the seventh embodiment is a closing mechanism 90 disposed on the sealing portion 24, and the closing mechanism 90 axially covers the proximal end of the sealing portion to prevent blood, thrombus, etc. in the left atrial appendage from being left. Specifically, the method comprises the following steps:

the closing mechanism 90 in the seventh embodiment includes a slot ring 91 connected to the connector 240, a rotating base 93 rotatably disposed in the slot ring 91, a plurality of closing pieces 94 slidably connected between the rotating base 93 and the slot ring 91, and a rotating shaft 95 connected to the rotating base 93; the closing mechanism 90 is provided with a channel, which is a through hole 951 for the multi-electrode catheter 40 and the inner sheath catheter 60 to pass through, and the channel is formed by the clamping groove ring 91 and the rotating base 93 along the axial direction.

In this embodiment, the proximal end of the snap ring 91 is fixedly connected to the inner cavity wall of the connector 240. The rotation shaft 95 rotates relative to the slot-locking ring 91 to drive the rotation base 93 to rotate relative to the slot-locking ring 91, so that the plurality of closing pieces 94 slide relative to the slot-locking ring 91 and the rotation base 93 to open or close the through hole 951.

The through holes 951 are opened, that is, the plurality of closing pieces 94 are dispersedly arranged on the path of the through holes 951, and gaps are formed on the path of the through holes 951 among the plurality of closing pieces 94, so that the through holes 951 formed by the clamping groove ring 91 and the rotating base 93 are communicated with each other, and the insertion of the multi-electrode catheter 40 is facilitated. The through holes 951 are closed, that is, a plurality of closing pieces 94 are intensively arranged on the path of the through holes 951 to form a barrier, so that the through holes 951 formed by the snap ring 91 and the rotating base 93 are isolated from each other by the closing pieces 94 and are not communicated with each other to block blood flow. In this embodiment, the axes of the through holes 951 formed in the notch ring 91 and the rotary base 93 are coincident with each other. In other embodiments, the axes of the through holes 951 formed in the slot ring 91 and the rotating base 93 are not limited to be coincident.

The plurality of closing pieces 94 are sandwiched between the slot-locking ring 91 and the rotating base 93, and are slidably connected to the slot-locking ring 91 and the rotating base 93. The slot-locking ring 91 extends a plurality of extending bars 912 to the inner cavity thereof, the rotating base 93 is provided with a plurality of guiding slots 932, one side of each closing piece 94 is slidably connected to the corresponding guiding slot 932, the other side of each closing piece 94 is slidably connected with the corresponding extending bar 912, and the rotating base 93 rotates relative to the slot-locking ring 91 to drive the plurality of closing pieces 94 to slide along the corresponding guiding slots 932 and extending bars 912, so that the plurality of closing pieces 94 open or close the through holes 951.

In this embodiment, each extension 912 has a channel 914 along its length. The side of each of the closing pieces 94 facing the corresponding extending strip 912 is provided with a driving lever 942 slidably received in the corresponding guide slot 914, and the rotating base 93 rotates relative to the slot-locking ring 91 to drive the closing pieces 94 to slide along the corresponding guide slots 932 and the guide slots 914, so that the closing pieces 94 open or close the through holes 951.

In other embodiments, each of the closing pieces 94 is provided with a guide slot and a guide slot, and the extending bar 912 and the rotating base 93 are provided with a shift lever slidably received in the corresponding guide slot or guide slot, so as to realize the sliding connection between the closing piece 94 and the slot-locking ring 91 as well as the rotating base 93.

As shown in fig. 15 and 16, in the present embodiment, three guide sliding grooves 932 are formed around the through hole 951 of the rotating base 93, and the three guide sliding grooves 932 are connected end to form a triangle; the driving lever 942 is protruded from each of the closing pieces 94 corresponding to the guiding groove 914. Each closing piece 94 is pentagonal and comprises a sliding edge 943 corresponding to the sliding guide groove 932, extending edges 944 arranged at two opposite ends of the sliding edge 943, and two split edges 945 arranged at one side of the two extending edges 944 far away from the sliding edge 943; a sliding guide bar (not shown) slidably received in the sliding guide groove 932 is disposed at the position of the closing sheet 94 adjacent to the sliding edge 943, and when the plurality of closing sheets 94 close the through hole 951, two splicing edges 945 of each two adjacent closing sheets 94 are attached to each other, as shown in fig. 15; when the plurality of closing pieces 94 open the through hole 951, the two split sides 945 of each adjacent two closing pieces 94 are staggered to define a through hole communicating the through hole 951, as shown in fig. 16. In this embodiment, the rotating base 93 and the rotating shaft 95 are fixedly connected by welding or adhesive bonding.

The direction of the arrows shown in fig. 16 and 17 is a first direction, and the direction opposite to the first direction is a second direction. When the multi-electrode catheter is used specifically, the rotating shaft 95 drives the rotating base 93 to rotate along the first direction, so that each closing sheet 94 slides along the corresponding guide chute 932 and the corresponding guide groove 914 to be staggered, and the through holes formed by the staggered split edges 945 of the closing sheets 94 are communicated with the through holes 951, so that the multi-electrode catheter can be conveniently inserted, as shown in fig. 16; the rotating shaft 95 drives the rotating base 93 to rotate along the second direction, so that each of the closing pieces 94 slides along the corresponding sliding guide channel 932 and the corresponding guiding groove 914 to gather together, and the corresponding splicing edges 945 of the closing pieces 94 are attached to close the through hole 951, so that blood, thrombus and the like in the left atrial appendage are left out, as shown in fig. 15.

In the present embodiment, the first direction is a clockwise direction, and the second direction is a counterclockwise direction. In other embodiments, the first direction is counterclockwise and the second direction is clockwise.

As shown in fig. 13 and 17, in the present embodiment, the closing mechanism 90 further includes a rotation cable 97 and a handle (not shown) disposed at a proximal end of the rotation cable 97, and the handle is connected to the rotation cable 97 to control the rotation of the rotation cable 97. The far end of the rotating steel cable 97 is connected with the rotating shaft 95 through threads, the near end of the clamping groove ring 91 is provided with an extending cylinder 915 surrounding the rotating shaft 95, a gap is arranged between the rotating shaft 95 and the extending cylinder 915, the extending cylinder 915 is provided with at least one limiting groove 916 along the circumferential direction of the extending cylinder 915, the rotating shaft 95 is provided with an elastic stopping sheet 953 corresponding to the limiting groove 916, namely, the elastic stopping sheet 953 can be inserted into the limiting groove 916 in a sliding mode, the elastic stopping sheet 953 is obliquely arranged, and the limiting groove 916 is used for controlling the elastic stopping sheet 953 to rotate in one direction.

In the process that the handle controls the rotating cable 97 to rotate along the first direction, the rotating cable 97 is gradually screwed with the rotating shaft 95; in the state that the rotating cable 97 is screwed with the rotating shaft 95, when the rotating cable 97 drives the rotating shaft 95 to rotate along the first direction, the plurality of closing pieces 94 respectively slide along the corresponding guide chute 932 and the corresponding extending strip 912 to open the through hole 951, and the elastic stopping piece 953 slides along the first direction; in the process that the handle controls the rotating steel cable 97 to rotate along the second direction, the rotating steel cable 97 drives the rotating shaft 95 to rotate along the second direction, and the plurality of closing pieces 94 respectively slide along the corresponding guide sliding grooves 932 and the corresponding extending strips 912 to close the through hole 951; in a state where the plurality of closing pieces 94 close the through hole 951, the screw thread connection between the rotating wire rope 97 and the rotating shaft 95 is gradually loosened in the process that the rotating wire rope 97 is rotated in the second direction.

In this embodiment, the outer wall of the rotating shaft 95 is uniformly provided with three elastic stopping pieces 953 along the circumferential direction thereof, the outer wall of the extending cylinder 915 is provided with three limiting grooves 916 corresponding to the three elastic stopping pieces 953, and the rotating shaft 95 rotates along the first direction to drive the elastic stopping pieces 953 to rotate without stopping with the corresponding limiting grooves 916, so as to conveniently drive the closing pieces 94 to move away from each other to open the through hole 951; the rotation axis 95 rotates along the second direction and drives elasticity end separation blade 953 and rotate and can with the spacing groove 916 backstop that corresponds, guaranteed that elasticity end separation blade 953 is the same along first direction and second direction pivoted angle, be favorable to realizing the complete closure between the closure piece 94, avoided because elasticity end separation blade 953 is different along first direction and second direction pivoted angle, the unable complete closed problem of blood flow passageway appears of existence between the closure piece 94 that leads to. When the closing pieces 94 are gathered to close the through hole 951, the rotating wire rope 97 is rotated continuously along the second direction to separate the rotating wire rope 97 from the rotating shaft 95, so that the rotating wire rope 97 is convenient to withdraw from the body.

The distal end of the rotary cable 97 is screwed to the rotary shaft 95, and the direction of unscrewing coincides with the direction in which the rotary shaft 95 cannot rotate. After the passage between the closure pieces 94 is completely closed, the rotating cable 97 continues to rotate in the second direction to unthread the threads of the rotating shaft 95, facilitating the withdrawal from the body.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims

1. A left atrial appendage occlusion device comprises an occlusion piece, an ablation piece and a mapping piece, wherein the ablation piece is connected with the occlusion piece and is used for being fixed at an opening of a left atrial appendage, the ablation piece is used for transmitting ablation energy to ablate a target tissue region in the left atrial appendage, and the mapping piece is used for receiving electrophysiological signals to map the target tissue region.

2. A left atrial appendage occlusion device as in claim 1, wherein the ablating member and/or the mapping member are releasably attached to the occluding member.

3. The left atrial appendage occlusion device of claim 2, further comprising a multi-electrode catheter, the occlusion being a hollow structure, the multi-electrode catheter being releasably insertable through the occlusion, the multi-electrode catheter including a distal segment at a distal end thereof, the mapping element being a plurality of mapping electrodes disposed at the distal segment of the multi-electrode catheter.

4. A left atrial appendage occlusion device as in claim 3, wherein a distal segment of the multi-electrode catheter is configured to extend beyond a distal end of the occlusion piece such that the mapping electrodes are in contact with target tissue to receive electrophysiological signals.

5. The left atrial appendage occlusion device of claim 3, wherein the ablation member is a plurality of ablation electrodes disposed on the distal section, the plurality of ablation electrodes and the plurality of mapping electrodes being spaced apart from one another at the distal section, the distal section being configured for receipt within a lumen of the occlusion member or extending beyond a distal end of the occlusion member to deliver ablation energy to a target tissue region.

6. The left atrial appendage occlusion device of claim 5, wherein the distal section of the multi-electrode catheter is pre-shaped into at least one annular configuration.

7. The left atrial appendage occlusion device of claim 6, wherein the distal section of the multi-electrode catheter is pre-shaped with a plurality of annular structures arranged in an axial direction, the diameter of the annular structures being smaller closer to the distal end.

8. The left atrial appendage occlusion device of claim 5, wherein the multi-electrode catheter comprises a plurality of carrier rods arranged in a circumferential sequence, wherein distal and proximal ends of the plurality of carrier rods are joined together, respectively.

9. The left atrial appendage occlusion device of claim 8, wherein the at least one load bearing rod extends helically about the axial direction.

10. The left atrial appendage occlusion device of claim 5, wherein the mapping electrode is disposed proximally and distally relative to the ablation electrode on the multi-electrode catheter.

11. The left atrial appendage occlusion device of claim 5, wherein the multi-electrode catheter comprises a carrier member and a lead wire disposed on the carrier member, and wherein the ablation electrode and the mapping electrode are electrically connected to an ablation energy source and a mapping signal receiver, respectively, via the lead wire.

12. A left atrial appendage occlusion device as in claim 5, wherein the ablating member is disposed on the occlusion member.

13. A left atrial appendage occlusion device as in claim 12, wherein the occlusion piece comprises an anchoring portion and a sealing portion connected proximal to the anchoring portion, the ablation electrode being disposed on a surface of the anchoring portion.

14. A left atrial appendage occlusion device as in any of claims 3-12, wherein the occlusion element comprises an anchoring portion and a sealing portion coupled to a proximal end of the anchoring portion, wherein at least one fluid-resistant membrane is disposed in the sealing portion and/or the anchoring portion, and wherein the distal segment of the multi-electrode catheter is received within the lumen of the sealing portion, the lumen of the anchoring portion, or extends beyond the distal end of the anchoring portion after passing through the at least one fluid-resistant membrane.

15. The left atrial appendage occlusion device of claim 14, wherein the flow blocking membrane has elasticity, the flow blocking membrane comprises a plurality of sub-valves disposed around the perforations, gaps are disposed between adjacent sub-valves, and the perforations are formed between the sub-valves for the insertion of the multi-electrode catheter; the plurality of petals are squeezed to deform to open the perforation as the multi-electrode catheter is passed through the perforation, and are repositioned to close the perforation after the multi-electrode catheter is withdrawn from the perforation.

16. The left atrial appendage occlusion device of claim 14, wherein the occlusion further comprises a seal disposed on one side of the flow-blocking membrane, the seal having a channel through which the multi-electrode catheter passes, the channel closing upon withdrawal of the multi-electrode catheter from the channel.

17. The left atrial appendage closure device of claim 16, wherein the seal is made of a resilient, blood clotting and flow blocking material and the channel is a slit.

18. A left atrial appendage occlusion device as in claim 16, wherein the channels of the seal are staggered with the perforations of the flow-blocking membrane.

19. The left atrial appendage occlusion device of claim 16, wherein the sealing member is disposed within an interior lumen of the occlusion member.

20. The left atrial appendage occlusion device of claim 16, wherein a proximal end of the sealing portion is provided with a connector having a connection aperture therethrough in an axial direction, the sealing member being disposed in the connection aperture.

21. The left atrial appendage occlusion device of claim 20, wherein the sealing element is a closure mechanism disposed on the sealing portion, the closure mechanism comprises a slot ring coupled to the connector, a rotating base rotatably disposed within the slot ring, a plurality of closure tabs slidably coupled between the rotating base and the slot ring, and a rotating shaft coupled to the rotating base, the channel is a through hole axially disposed between the slot ring and the rotating base for the multi-electrode catheter to pass through, the rotating shaft drives the rotating base to rotate relative to the slot ring, such that the plurality of closure tabs slide relative to the slot ring and the rotating base, and thus are in a path of the through hole formed by the slot ring and the rotating base,

the plurality of closing pieces are distributed and form gaps among the closing pieces, and the clamping groove rings are communicated with through holes respectively formed by the rotating base so as to open the through holes; or

The plurality of closing pieces are arranged in a concentrated mode to form a barrier, and the through holes formed by the clamping groove ring and the rotating base are isolated from each other through the plurality of closing pieces so as to close the through holes.

22. The left atrial appendage occlusion device of claim 21, wherein the slot ring extends a plurality of extension bars into an inner cavity thereof, the plurality of closure tabs are disposed between the plurality of extension bars and the rotating base, the rotating base is provided with a plurality of guide slots, one side of each closure tab is slidably connected to the corresponding guide slot, the opposite side of each closure tab is slidably connected to the corresponding extension bar, and the rotating base rotates relative to the slot ring to drive the plurality of closure tabs to slide along the corresponding guide slots and the corresponding extension bars.

23. The left atrial appendage occlusion device of claim 22, wherein the closure mechanism further comprises a rotation cable and a handle connected to the rotation cable for controlling rotation of the rotation cable, a distal end of the rotation cable being in threaded connection with the rotation shaft;

in the process that the rotating steel cable rotates along the first direction, the rotating steel cable and the rotating shaft are gradually screwed; when the rotating steel cable and the rotating shaft are in a screwed state, and the rotating steel cable drives the rotating shaft to rotate along a first direction, the plurality of closing pieces respectively slide along the corresponding guide sliding grooves and the corresponding extending strips to open the through holes;

when the handle controls the rotating steel cable to rotate along the second direction, the rotating steel cable drives the rotating shaft to rotate along the second direction, and the plurality of closing pieces respectively slide along the corresponding guide sliding grooves and the corresponding extending strips to close the through holes; and under the state that the through holes are closed by the closing pieces, the rotating steel cable and the rotating shaft are gradually loosened in the process that the rotating steel cable rotates along the second direction.

24. The left atrial appendage occlusion device of claim 14, further comprising an inner sheath releasably coupled to the occlusion, the multi-electrode catheter disposed through a lumen of the inner sheath, a distal end of the multi-electrode catheter coupled to a distal end of the inner sheath, the distal end of the inner sheath passing through the at least one flow-blocking membrane and being insertable within the sealing portion, the anchoring portion, or the occlusion, the multi-electrode catheter extending from the distal end of the inner sheath and defining an annulus.

25. The left atrial appendage occlusion device of claim 24, wherein a distal end of the inner sheath is fixedly coupled to a distal end of the multi-electrode catheter.