Left atrial appendage occlusion device

Abstract

The present invention provides a left atrial appendage occlusion device, which includes an occlusion member, an ablation member connected to the occlusion member, and a mapping member. The occlusion member is used to be fixed at the opening of the left atrial appendage, the ablation member is used to transmit ablation energy to ablate the target tissue area in the left atrial appendage, and the mapping member is used to receive electrophysiological signals to map the target tissue area. The left atrial appendage occlusion device can not only occlude the opening of the left atrial appendage, but also control the ablation member to ablate the target tissue area in the left atrial appendage, and the mapping member can map the electrical signals in the left atrial appendage to ensure that a complete ablation area of ​​at least one circle is formed near the opening of the left atrial appendage to achieve a complete electrical isolation treatment effect.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a left atrial appendage occlusion device for occluding and ablating the left atrial appendage. Background Art

[0002] Atrial fibrillation (AF) is the most common persistent cardiac arrhythmia. Its incidence increases with age, reaching 10% in people over 75. During AF, the atrial excitation rate reaches 300 to 600 beats per minute, and the heart rate is often rapid and irregular, sometimes reaching 100 to 160 beats per minute. This is not only much faster than a normal heartbeat, but also completely irregular, causing the atria to lose their effective contractile function. The prevalence of AF is also closely associated with coronary artery disease, hypertension, and heart failure.

[0003] The left atrial appendage (LAA), due to its special morphology and structure, is not only the most important site for atrial fibrillation (AF) thrombosis formation, but also one of the key areas for its occurrence and maintenance. Some AF patients can benefit from active LAA electrical isolation.

[0004] To prevent thrombi formed in the left atrial appendage from flowing out of the heart with blood due to atrial fibrillation and causing a stroke, a percutaneous left atrial appendage occlusion device uses a special occluder to occlude the left atrial appendage. It is a treatment method that has been developed in recent years and is less invasive, simple to operate, and less time-consuming. The basic structure of existing left atrial appendage occlusion devices is similar, that is, an expandable polymer membrane is wrapped around the outside of a self-expanding nickel-titanium memory alloy cage-like structure stent. The rod of the nickel-titanium alloy stent has an anchor hook (similar to the barb on a fishhook) that can help the device be fixed in the atrial appendage to prevent it from falling off. The polymer membrane can seal the atrial entrance of the left atrial appendage, isolating the left atrial appendage and the left atrial body, preventing blood flow from communicating. After the left atrial appendage occlusion device is inserted, the left atrial endothelial cells will crawl and grow on the surface of the polymer membrane, and after a period of time, new endothelium will be formed.

[0005] However, simple left atrial appendage occlusion can only prevent stroke but cannot improve the symptoms of atrial fibrillation. Summary of the Invention

[0006] The object of the present invention is to provide a left atrial appendage occlusion device, which can achieve occlusion, mapping and ablation of the inner wall of the left atrial appendage.

[0007] In order to solve the above technical problems, the present invention provides a left atrial appendage occlusion device, including an occluding member, an ablation member connected to the occluding member, and a mapping member, wherein the occluding member is used to be fixed at the opening of the left atrial appendage, the ablation member is used to transmit ablation energy to ablate the target tissue area in the left atrial appendage, and the mapping member is used to receive electrophysiological signals to map the target tissue area.

[0008] The left atrial appendage occlusion device provided by the present invention can not only occlude the opening of the left atrial appendage, but also control the ablation component to ablate the target tissue area in the left atrial appendage, and the mapping component can map the electrical signals in the left atrial appendage to ensure that a complete ablation area of ​​at least one circle is formed near the opening of the left atrial appendage, thereby achieving a complete electrical isolation treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0010] Figure 1 1 is a schematic structural diagram of a left atrial appendage occlusion device provided by a first embodiment of the present invention;

[0011] Figure 2 yes Figure 1 A schematic diagram of the structure of a portion of a multi-electrode catheter and a portion of a sheath of a left atrial appendage occlusion device;

[0012] Figure 3 yes Figure 1 A diagram showing the status of the left atrial appendage occlusion device used to map electrical signals in the left atrial appendage;

[0013] Figure 4 The diagram is a partial three-dimensional structural diagram of the flow-blocking membrane and the inner sheath tube of the sealing portion in one embodiment;

[0014] Figure 5 is a schematic structural diagram of a left atrial appendage occlusion device provided by a second embodiment of the present invention;

[0015] Figure 6 is a schematic structural diagram of a left atrial appendage occlusion device provided by a third embodiment of the present invention;

[0016] Figure 7 yes Figure 6 A schematic structural diagram of another embodiment of the sealing member;

[0017] Figure 8 yes Figure 6 A schematic diagram of a partial cross-sectional structure of a multi-electrode catheter and an inner sheath of a left atrial appendage occlusion device;

[0018] Figure 9 is a schematic structural diagram of a left atrial appendage occlusion device provided by a fourth embodiment of the present invention;

[0019] Figure 10 is a schematic structural diagram of a multi-electrode catheter provided by a fifth embodiment of the present invention;

[0020] Figure 11 is a schematic structural diagram of a multi-electrode catheter provided by a sixth embodiment of the present invention;

[0021] Figure 12 yes Figure 11 Bottom view of the multi-electrode catheter in FIG;

[0022] Figure 13 is a cross-sectional view of a sealing member of a left atrial appendage occlusion device provided in accordance with a seventh embodiment of the present invention;

[0023] Figure 14 yes Figure 13 A schematic diagram of the three-dimensional structure of the sealing rotating base and one of the closing pieces;

[0024] Figure 15 yes Figure 13 A schematic diagram of one state of the seal;

[0025] Figure 16 yes Figure 13 A schematic diagram of another state of the seal in FIG.

[0026] Figure 17 yes Figure 13 A cross-sectional view of the rotating shaft of the seal and the extension cylinder on the groove ring. DETAILED DESCRIPTION

[0027] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0028] In the description of this invention, the "proximal end" refers to the end closest to the operator during surgery, and the "distal end" refers to the end farther from the operator during surgery. Axial refers to the direction of the device's central axis, and radial refers to the direction perpendicular to the central axis. This definition is for convenience only and should not be construed as a limitation of the invention. "Connection between component A and component B" refers to direct contact and connection between component A and component B, or indirect connection between component A and component B through another component.

[0029] Please also refer to Figures 1 to 3The present invention provides a left atrial appendage occlusion device 100, comprising an occlusion member 20, an ablation member 30 connected to the occlusion member 20, and a mapping member 70. The occlusion member 20 is used to be fixed at the opening of the left atrial appendage; the ablation member 30 is connected to an external ablation energy source, and is used to transmit ablation energy to ablate the target tissue area in the left atrial appendage; the mapping member 70 is connected to an external mapping signal receiver, and is used to receive electrophysiological signals to map the target tissue area. In this embodiment, the ablation energy source is a high-frequency pulse source. The occlusion member 20 is disposed at the distal end of the left atrial appendage occlusion device 100. It is understandable that the left atrial appendage occlusion device 100 also includes a handle (not shown) disposed at the proximal end and an outer sheath (not shown) connected between the handle and the occlusion member 20. The handle is used to control the ablation member 30 and the mapping member 70 to cooperate with each other to achieve the effects of ablation and mapping.

[0030] In this embodiment, the occluding member 20 is a hollow structure. Specifically, the occluding member 20 is cut and shaped from a nickel-titanium alloy tube. The occluding member 20 is in a "top hat" shape when fully released. The left atrial appendage occluding device 100 also includes a multi-electrode catheter 40 that is detachably connected to the occluding member 20. The multi-electrode catheter 40 includes a distal segment 42 located at its distal end. The ablation member 30 and the mapping member 70 are arranged on the distal segment 42 of the multi-electrode catheter 40. The distal segment 42 can be accommodated in the occluding member 20 or extend out of the distal end of the occluding member 20, that is, the distal segment 42 can extend from the distal end of the occluding member 20. At this time, the distal end of the occluding member 20 is closer to the handle than the distal segment 42, and the mapping member 70 on the distal segment 42 contacts the target tissue to receive electrophysiological signals.

[0031] The occluding member 20 of the left atrial appendage occluding device 100 of the present invention is used to be fixed at the opening of the left atrial appendage to occlude the opening of the left atrial appendage, the ablation member 30 is used to transmit ablation energy to ablate the target tissue area in the left atrial appendage, and the mapping member 70 is used to receive electrophysiological signals to map the target tissue area. Therefore, the left atrial appendage occluding device 100 can not only occlude the opening of the left atrial appendage, but also control the ablation member 30 to ablate the target tissue area in the left atrial appendage, and the mapping member 70 can map the electrical signals in the left atrial appendage to ensure that a complete ablation area of ​​at least one circle is formed near the opening of the left atrial appendage to achieve a complete electrical isolation treatment effect.

[0032] like Figure 1As shown, the occluding member 20 includes a self-expanding support frame. Specifically, the occluding member 20 may include an elastic metal support frame or an elastic non-metallic support frame. Optionally, the occluding member 20 also includes a barrier member provided on the support frame. In this embodiment, the occluding member 20 includes an elastic metal cutting stent. Preferably, the occluding member 20 is a stent cut from a nickel-titanium alloy tube. The outer sheath is hollow and tubular and is connected between the handle and the occluding member 20. When the left atrial appendage occluding device 100 delivers the occluding member 20 through the outer sheath, the diameter of the occluding member 20 can be contracted to a smaller state for delivery in the outer sheath; when the occluding member 20 extends from the distal end of the outer sheath and is released near the left atrial appendage opening, the occluding member 20 can automatically expand so that the outer wall of the occluding member 20 is completely in contact with the inner wall of the opening of the left atrial appendage.

[0033] In this embodiment, the plugging member 20 is a hollow structure after release within the body. In this embodiment, the plugging member 20 is cut from tubing. The plugging member 20 can also be woven from wire, or partially woven and partially cut from tubing. Different parts can be welded or secured to each other via connectors. The tubing is made of metal or non-metallic material, preferably a memory metal material such as nickel-titanium alloy. The overall shape of the plugging member 20 can also be cylindrical, disc-shaped, conical, or any other suitable shape, which is not limited here.

[0034] In this embodiment, the occluding member 20 includes an anchoring portion 22 and a sealing portion 24 connected to the proximal end of the anchoring portion 22. The anchoring portion 22 and the sealing portion 24 form an integral grid-like support framework cut from a single nickel-titanium alloy tube. In an alternative embodiment, the anchoring portion 22 and the sealing portion 24 are each cut from a single nickel-titanium alloy tube and connected by a connector. A multi-electrode catheter 40 is detachably connected to the proximal end of the sealing portion 24; the distal end 42 of the multi-electrode catheter 40 is accommodated within the lumen of the sealing portion 24, the lumen of the anchoring portion 22, or extends beyond the distal end of the anchoring portion 22; the distal end 42 is pre-shaped to form at least one annular structure, i.e., the distal end 42 forms at least one annular 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.

[0035] The distal end of the anchoring portion 22 is turned outward into a hemispherical shape. Specifically, the anchoring portion 22 includes a plurality of connecting rods 221 located in the middle of the anchoring portion 22 and arranged circumferentially, an anchoring frame 223 connected to the distal end of the connecting rod 221, and an inner folding frame 227 connected to the proximal end of the anchoring frame 223; the distal end of each connecting rod 221 is turned outward into an arc shape, and the proximal end of each connecting rod 221 is connected to the sealing portion 24.

[0036] The anchoring frame 223 is used to press against the inner wall of the left atrial appendage opening around its perimeter, thereby securing the entire occluding member 20 at the left atrial appendage opening and preventing it from loosening. The anchoring frame 223 is grid-like, forming a plurality of hexagonal meshes arranged circumferentially around the anchoring portion 22. It is understood that in alternative embodiments, the anchoring frame 223 may also form meshes of other shapes, such as square, diamond, strip, or other irregular shapes. Furthermore, the anchoring frame 223 includes a distal wave-shaped anchoring ring 2231 connected to the distal end of the connecting rod 221, a plurality of connecting strips 2233 connected to the trough of the distal wave-shaped anchoring ring 2231, and a proximal wave-shaped anchoring ring 2235 connected to the proximal end of the connecting strip 2233; that is, the crest of the distal wave-shaped anchoring ring 2231 is connected to the distal end of the corresponding connecting rod 221, the trough of the distal wave-shaped anchoring ring 2231 is connected to the distal end of the corresponding connecting strip 2233, the crest of the proximal wave-shaped anchoring ring 2235 is connected to the proximal end of the corresponding connecting strip 2233, and the trough of the proximal wave-shaped anchoring ring 2235 is connected to the inner folding frame 227. That is, the multiple hexagonal meshes 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 meshes are separated by the connecting strips 2233.

[0037] The inner folding frame 227 includes an inner folding rod 2271 bent from each trough of the proximal wave-shaped anchoring ring 2235 toward the inside of the anchoring frame 223, and the ends of each two adjacent inner folding rods 2271 away from the corresponding trough of the proximal wave-shaped anchoring ring 2235 are gathered together.

[0038] The outer surface of the anchoring portion 22 is provided with a plurality of barbs 2236, and the barbs 2236 are arranged in at least one circle along the circumference of the anchoring portion 22. Since the barbs 2236 are provided on the outer surface of the anchoring portion 22, when the occluding member 20 is implanted into the inner cavity of the left atrial appendage, the barbs 2236 can penetrate into the inner wall of the left atrial appendage, so that the entire occluding device 100 can fit tightly in the left atrial appendage without falling off, and at the same time facilitate the recovery of the multi-electrode catheter 40. Specifically, the barbs 2236 are provided on the outer wall of the connecting strip 2233, and these barbs 2236 are arranged in a circle along the circumference of the anchoring portion 22. Preferably, the number of barbs 2236 in at least one circle is between 8 and 16. In this embodiment, the outer wall of each connecting strip 2233 is provided with barbs 2236.

[0039] In other embodiments, the outer wall of the distal wave-shaped anchoring ring 2231 and / or the proximal wave-shaped anchoring ring 2235 is provided with at least one circle of barbs 2236; preferably, a barb 2236 extends outward from each wave valley and / or each wave peak of the distal wave-shaped anchoring ring 2231, and / or a barb 2236 extends outward from each wave valley and / or each wave peak of the proximal wave-shaped anchoring ring 2235.

[0040] When fully released, the sealing portion 24 presents a yurt-shaped mesh structure. The distal end of the sealing portion 24 extends to the inner cavity of the anchoring portion 22 and is connected to the proximal ends of several connecting rods 221. The proximal end of the sealing portion 24 is connected to a connector 240 after being aggregated at its middle. The connector 240 is provided with a through hole 242 along the axial direction for the multi-electrode catheter 40 to pass through.

[0041] In other embodiments, the occluding member 20 only needs to be hollow in the middle and have a channel 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.

[0042] The multi-electrode catheter 40 is in the shape of a long tube and is made of an elastic material. Its distal end section 42 is pre-shaped into a ring structure. That is, in its natural state, the distal end section 42 is in a ring shape. Under the action of an external force, the distal end section 42 can undergo elastic deformation. After the external force is removed, the distal end section 42 returns to the predetermined ring shape. Correspondingly, the left atrial appendage occlusion device 100 also includes a long tubular inner sheath 60 for accommodating the multi-electrode catheter 40. The multi-electrode catheter 40 is pre-installed in the inner sheath 60. In the delivery state, the distal end section 42 is placed in the inner sheath 60 in a straight line. The portion of the distal end section 42 released from the inner sheath 60 returns to the predetermined shape. After the distal end section 42 is completely released from the inner sheath 60, the distal end section 42 returns to the predetermined ring shape. Multi-electrode catheter 40 includes a tubular carrier member 41 made of an elastic insulating material. The main body of multi-electrode catheter 40 is carrier member 41, and the distal end of carrier member 41 is pre-shaped as distal segment 42. Carrier member 41 is provided with distal segment 42 at its distal end, which is pre-shaped into at least one ring.

[0043] like Figure 2 As shown, the ablation element 30 is a plurality of ablation electrodes disposed at the distal segment 42, and the mapping element 70 is a plurality of mapping electrodes disposed at the distal segment 42. The distal segment 42 is pre-shaped into a ring, which facilitates the ablation electrodes to form a ring-shaped pulsed electric field with uniform electric field strength, thereby electrically isolating tissue cells near the left atrial appendage orifice and forming a complete ring-shaped ablation area around the inner wall of the left atrial appendage.

[0044] Specifically, a number of ablation electrodes and a number of mapping electrodes are spaced apart from each other in the distal section 42, that is, each ablation electrode and mapping electrode is arranged on the outer surface of the distal section 42, and adjacent ablation electrodes, adjacent ablation electrodes and mapping electrodes, and adjacent mapping electrodes and mapping electrodes are spaced apart from each other, with gaps formed in the middle to insulate each other.

[0045] In this embodiment, the ablation electrodes and the mapping electrodes are arranged in an interlaced manner, that is, at least one mapping electrode is provided between two adjacent ablation electrodes, and at least one ablation electrode is provided between two adjacent mapping electrodes. In other embodiments, the ablation electrodes and the mapping electrodes are not limited to being interlaced. Preferably, the plurality of ablation electrodes on the distal segment 42 are evenly spaced along the axial direction of the distal segment 42, and the plurality of mapping electrodes are evenly spaced along the axial direction of the distal segment 42.

[0046] like Figure 2 As shown, the multi-electrode catheter 40 also includes a wire 43 provided on the carrier 41. The ablation electrode and the mapping electrode are electrically connected to the external ablation energy source and the mapping signal receiver respectively through the wire 43, that is, a part of the wire 43 is connected between the ablation electrode and the external ablation energy source. In this embodiment, different ablation electrodes are connected to different wires 43. In an alternative embodiment, a group of ablation electrodes can share a wire 43, that is, at least part of the ablation electrodes are connected to the same wire 43. Another part of the wire 43 is connected between the mapping electrode and the external mapping signal receiver. In this embodiment, different mapping electrodes are used to be connected to different wires 43. In an alternative embodiment, a group of mapping electrodes can share a wire 43, that is, at least part of the mapping electrodes are connected to the same wire 43. In other embodiments, the ablation electrodes on the distal segment 42 can be connected in series through a wire 43, and the mapping electrodes on the distal segment 42 can also be connected in series through a wire.

[0047] In this embodiment, the wire 43 is housed in the inner cavity of the carrier 41, and its two ends are respectively connected to the ablation electrode and the external ablation energy source, or the two ends of the wire 43 are respectively connected to the mapping electrode and the external mapping signal receiver. In an alternative embodiment, the wire 43 is embedded in the wall of the carrier 41 and extends axially, and connects the corresponding electrode and the external device. In an alternative embodiment, the wire 43 is provided on the outer surface of the carrier 41, extends along the surface of the carrier 41 and connects the corresponding electrode and the external device.

[0048] The distal segment 42 can pass through the flow-blocking membrane 50 and be housed in the inner cavity of the sealing portion 24, the inner cavity of the anchoring portion 22, or extend out of the distal end of the anchoring portion 22, so that the ablation component 50 and the mapping component 70 on the distal segment 42 are housed in the inner cavity of the occluding portion 20 or are exposed to the distal end of the occluding portion 20. When the multi-electrode catheter 40 is housed in the inner cavity of the sealing portion 24 or the inner cavity of the anchoring portion 22, the ablation component 50 can ablate the target tissue area in the left atrial appendage; when the multi-electrode catheter 40 extends out of the distal end of the anchoring portion 22, the mapping component 70 can contact the target tissue to receive electrophysiological signals. It is understandable that in a modified embodiment, the multi-electrode catheter 40 is used to extend out of the distal end of the anchoring portion 22 to ablate the target tissue area.

[0049] like Figure 1 As shown, in this embodiment, at least one barrier is provided in the sealing portion 24, and the barrier is used to prevent the thrombus in the left atrial appendage from entering the atrium.

[0050] The barrier may be a flow-blocking membrane or other element used to block thrombus. The barrier may not allow thrombus to pass through, but may allow a small amount of blood to pass through, or may not allow thrombus to pass through or blood to pass through. The barrier may have multiple openings, and by setting the porosity and / or pore size, the barrier may have a permeability function, that is, it allows blood flow to pass through while blocking thrombus. The surface of the barrier may also be plated or covered with an anticoagulant (such as heparin) or other compound, or the surface of the barrier may be treated to give it antithrombin properties.

[0051] For a barrier with openings, the pore size can range from 65 to 1000 microns. It is understood that the pore size can also be slightly larger than 1000 microns or slightly smaller than 65 microns, as long as it can prevent the passage of thrombus. For example, it can be 65 to 400 microns. The porosity of the barrier refers to the percentage of the open area to the total area of ​​the barrier. The porosity of the barrier is at least 20%, and can be any range from 25% to 60%, which can be set as needed. The barrier can be a two-dimensional sieve, a porous membrane, a woven or non-woven mesh, or a similar structure. The barrier can be a metal with the above-mentioned permeability function or a metal mesh with fine fibers, or it can be made of a biocompatible material, such as ePFTE (for example), polyester (for example), PTFE (for example), silicone, urethane, metal fiber, or other biocompatible polymers, which are not described here in detail.

[0052] In this embodiment, the barrier is a flow barrier 50, which is attached to the support frame of the occluding member 20 via sutures or heat pressing. The flow barrier 50 prevents thrombi within the left atrial appendage from entering the atrium and constrains the occluding member 20, preventing deformation and enhancing structural stability. The flow barrier 50 seals the opening of the left atrial appendage, specifically at the proximal end of the lumen of the sealing portion 24, providing ample space within the sealing portion 24 for the multi-electrode catheter 40 to escape. In alternative embodiments, the barrier is disposed within the lumen of the sealing portion 24 and the anchoring portion 22, or within the lumen of the anchoring portion 22. It is understood that a barrier may also be disposed on the outer surface of the sealing portion 24 and / or the anchoring portion 22, thereby reducing the direct contact area between the support frame and the left atrial appendage tissue, reducing the pressure exerted by the support frame on the left atrial appendage tissue, ensuring more uniform force on the left atrial appendage tissue, and providing a certain degree of protection for the tissue. In this embodiment, the flow barrier 50 also has perforations for the multi-electrode catheter 40 to pass through.

[0053] The specific operation method of the left atrial appendage occlusion device 100 provided in this embodiment is as follows.

[0054] The multi-electrode catheter 40 is pre-installed in the inner sheath 60, and the inner sheath and the occluding component 20 are pre-installed in the outer sheath of the left atrial appendage occluding device 100 and transported together. The occluding component 20 is released at the opening position of the left atrial appendage. The multi-electrode catheter 40 is accommodated in the inner sheath 60 and is pushed forward together with the inner sheath 60. It passes through the through hole 242 of the connector 240 and the flow-blocking membrane 50 in the sealing part 24 in turn. The distal opening of the inner sheath 60 is located in the space between the flow-blocking membrane 50 and the distal end of the sealing part 24. The multi-electrode catheter 40 is released from the inner sheath 60 and restored to a ring shape in the sealing part 24. After the ablation component 30 is connected to an external ablation energy source, the ablation energy is transmitted to the tissue to ablate the target tissue area in the left atrial appendage; after the ablation is completed, the distal section 42 of the multi-electrode catheter 40 is withdrawn and retracted to In the inner sheath 60, the inner sheath 60 is pushed toward the distal end so that its distal end extends out of the distal end of the occluding member 20, and the distal segment 42 extends from the distal end of the inner sheath 60, so that the mapping member 70 contacts the target tissue on the inner wall of the left atrial appendage to collect electrophysiological signals in the target tissue area to achieve mapping; if it is judged that the ablation is incomplete based on the received electrophysiological signals and the electrical isolation effect is not achieved, the distal segment 42 needs to be placed in the inner cavity of the occluding member 20 to continue ablation, and then the distal segment 42 is extended out of the distal end of the occluding member 20 so that the electrical mapping member 70 collects electrophysiological signals in the target tissue area until the ablation is judged to be completed based on the received electrophysiological signals, and then the multi-electrode catheter 40 is retracted into the inner sheath 60, and the inner sheath 60 is withdrawn so that the inner sheath 60 passes through the flow-blocking membrane 50 and the through hole 242 and is separated from the proximal end of the occluding member 20.

[0055] In this embodiment, the ablation energy provided by the external ablation source is a high-voltage pulse energy source. Compared to other energy sources, this pulse ablation does not require heat conduction to ablate deep tissue. All tissue cells distributed above a certain electric field strength will undergo irreversible electroporation, which reduces the requirement for the distal end section 42 of the multi-electrode catheter 40 to be in close contact with the tissue during ablation. Therefore, even if the ablation element 30 does not completely adhere 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.

[0056] In other embodiments, the ablation energy source may be any one of radiofrequency energy source, microwave energy source, etc. The distal end section 42 of the multi-electrode catheter 40 is not limited to one annular deformation.

[0057] like Figure 4As shown, in one embodiment, the baffle membrane 50 is provided with a perforation 52 for the multi-electrode catheter 40 and the inner sheath tube 60 to pass through, and a petal structure design is adopted around the perforation 52. Specifically, the baffle membrane 50 is elastic, and the baffle membrane 50 includes a plurality of petal membranes 54 arranged around the perforation 52 and extending toward the perforation 52. A gap is provided between adjacent petal membranes 54, and a perforation 52 for the multi-electrode catheter 40 to pass through is formed between the plurality of petal membranes 54; when the multi-electrode catheter 40 passes through the perforation 52, the plurality of petal membranes 54 are squeezed and elastically deformed to open the perforation 52, thereby facilitating the insertion of the multi-electrode catheter 40 and the inner sheath tube 60; after the multi-electrode catheter 40 and the inner sheath tube 60 are withdrawn from the proximal end of the perforation 52, the plurality of petal membranes 54 are elastically reset and reclose the perforation 52 to block the thrombus or blood flow.

[0058] In other embodiments, the outer surface of the plugging member 20 is provided with at least one circumferential ring of developing dots or developing threads. Specifically, the outer surface of the anchor portion 22 and / or the sealing portion 24 is provided with a plurality of developing dots, which form at least one circumferential ring around the circumference of the plugging member 20. The developing dots are secured by inlaying, hot pressing, or other methods; the developing threads are secured by winding, inlaying, hot pressing, or other methods. The developing dots and developing threads can be made of materials such as gold, platinum, and tantalum.

[0059] See also Figure 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 ablation element in the second embodiment is disposed on the occlusion element 20. Preferably, the ablation element is disposed in at least one circle along the circumference of the outer wall of the occlusion element 20. The ablation element is disposed on the outer wall of the anchoring portion 22 and / or the sealing portion 24 of the occlusion element 20, and is disposed in at least one circle along the circumference. In this embodiment, the ablation element is disposed around the surface of the anchoring portion 22. The details are as follows:

[0060] The blocking piece 20 in the second embodiment is a conductive bare metal stent. The outer surface of the blocking piece 20 includes an insulating area and a conductive area. The surface of the insulating area is completely insulated, such as coated with an insulating coating. The surface of the conductive area is not insulated and can conduct electrical signals. The blocking piece 20 in the conductive area serves as an ablation piece 33, which is connected to an external ablation energy source through the connector 240 at the proximal end of the blocking piece 20. The ablation energy is transmitted to the ablation piece 33 through the blocking piece 20 to perform radiofrequency ablation on the left atrial appendage tissue attached to the ablation electrode 33, thereby forming a complete annular ablation on the inner wall of the left atrial appendage.

[0061] In this embodiment, the distal section 42 of the multi-electrode catheter 40 is released at the distal end of the occluding member 20, and the electrophysiological signals in the left atrial appendage are mapped by the mapping member 70 on the distal section 42. After the ablation is completed, the mapping member 70 is removed from the body along with the multi-electrode catheter 60, and the ablation member 33 and the occluding member 20 are retained in the body as an integrated structure, that is, the mapping member 70 is detachably connected to the occluding member 20. In a modified embodiment, the ablation member 30 is provided on the multi-electrode catheter, and the mapping member 70 is provided on the occluding member 20, and the ablation member 30 is detachably connected to the occluding member 20.

[0062] The blocking member 20 in this embodiment is made of conductive material, and part of the support frame of the blocking member 20 is directly used as an ablation member; preferably, a circle of ablation members 33 is set on the outer peripheral surface of the blocking member 20 where the radial dimension is the largest, that is, the entire blocking member 20 except for a part of the ablation member 33 is insulated, and the ablation member 33 is the part of the surface of the metal support frame that is not insulated, and at least one circle of the blocking member 20 is electrically exposed; in other embodiments, the outer peripheral surface and / or sealing member 22 of the anchoring portion 22 is electrically exposed. At least one circle of ablation elements 33 is disposed on the outer circumference of the sealing portion 24; specifically, at least one circle of ablation electrodes 33 is disposed on one of the outer circumference of the distal corrugated anchor ring 2231, the outer circumference of the plurality of connecting strips 2233, and the outer circumference of the proximal corrugated anchor ring 2235. That is, the outer surfaces of the distal corrugated anchor ring 2231, the outer surfaces of the plurality of connecting strips 2233, and the proximal corrugated anchor ring 2235, except for the ablation electrodes 33, are all insulated, or the outer surface of the sealing portion 24, except for the ablation electrodes 33, is all insulated. Insulating the outer surface of the sealing portion 20, except for the ablation electrodes 33, prevents the remaining outer surface from contacting blood and conducting electricity, thereby reducing impedance and preventing complete annular ablation of the inner wall of the left atrial appendage.

[0063] The insulation treatment can be achieved by coating the outer surface of the support frame of the blocking member 20 with an insulating coating or inserting an insulating sleeve over the support frame. Furthermore, the insulating coating used is a parylene-based insulating coating, and the insulating sleeve can be a FEP, ETFE, PFA, or PTFE sleeve. Because the blocking member 20 is inherently conductive, it transmits ablation energy to the ablating member 33, further concentrating the energy on the tissue in contact with the ablating member 33.

[0064] In other embodiments, the ablation component 33 can be an ablation electrode arranged on the supporting frame of the sealing component 20, such as an electrode wire, an electrode sheet or a ring electrode. The ablation electrode is electrically connected to the ablation energy source through an external power connection line. In order to concentrate the ablation energy on the ablation electrode, the supporting frame is insulated at the position where it contacts the ablation electrode, such as coating with an insulating layer or wrapping with an insulating film or an insulating sleeve.

[0065] In other embodiments, the supporting skeleton of the blocking member 20 may also be a supporting frame made of non-conductive material, and the ablation member 33 is at least one continuous or discontinuous circle arranged circumferentially along the outer surface of the supporting skeleton; or the ablation member 33 is a plurality of point electrodes or strip electrodes, and the plurality of point electrodes or strip electrodes are arranged at least one circle circumferentially along the outer wall surface of the blocking member 20.

[0066] In other embodiments, the ablation electrode 33 is a continuous single or multiple coils of electrode wire arranged along the circumference of the support frame of the plugging member 20; the electrode wire is connected to the support frame by winding, welding, or pressing; and the outer surface of the support frame is insulated, and the insulation treatment method is to apply an insulating coating to the outer surface of the support frame, or to cover the support frame with an insulating sleeve, or to cover the support frame with an insulating film. 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 silicone; and the insulating film is at least one insulating film selected from FEP, ETFE, PFA, PTFE, and silicone. The insulating film is connected to the support frame of the plugging member 20 by sewing, hot pressing, spraying, or dipping.

[0067] In other embodiments, at least one circle of ablation electrodes 33 is disposed on each of the outer circumference of the distal corrugated anchor ring 2231, the outer circumference of the plurality of connecting strips 2233, and the outer circumference of the proximal corrugated anchor ring 2235. Alternatively, at least one circle of ablation elements 33 is disposed on each of the outer circumference of the distal corrugated anchor ring 2231, the outer circumference of the plurality of connecting strips 2233, and the outer circumference of the proximal corrugated anchor ring 2235.

[0068] In this embodiment, the ablation energy is a radio frequency signal, and the multiple ablation elements 33 are connected to the same radio frequency signal. In a modified embodiment, the ablation energy is a pulse or microwave, and the multiple ablation elements 33 can be flexibly arranged as needed.

[0069] See also Figure 6 The structure of the left atrial appendage occlusion device 100b provided in the third embodiment of the present invention is similar to that of the first embodiment, except that the support frame of the occlusion member 20a in the third embodiment is different from that of the occlusion member 20 in the first embodiment, and the occlusion member 20a further includes a sealing member 80, which is accommodated in the inner cavity of the occlusion member 20a. Furthermore, the sealing member 80 is disposed on one side of the flow-blocking membrane 50 and has a passage for the multi-electrode catheter 40 to pass through. After the multi-electrode catheter 40 is withdrawn from the passage of the sealing member 50, the passage of the sealing member 80 is closed. Specifically:

[0070] The occluding member 20a is a hollow structure, comprising an anchoring portion 22 and a sealing portion 24. The anchoring portion 22 is disposed at the distal end relative to the sealing portion 24. The anchoring portion 22 and the sealing portion 24 are an integral grid-like support skeleton woven from nickel-titanium alloy wires. When fully released, the occluding member 20a is a barrel-shaped structure, with the anchoring portion 22 having an opening toward the distal end. In an alternative embodiment, the anchoring portion 22 is woven toward the distal end to form a bottom, through which the multi-electrode catheter 40 extends from the distal end of the occluding member 20. In addition, a circle of barbs 2236 are provided on the outer circumference of the anchoring portion 22 to ensure that the occluding member 20a can be stably anchored in the inner cavity of the left atrial appendage.

[0071] The seal 80 is made of an elastic, blood-blocking material. The passageway of the seal 80 closes after the multi-electrode catheter 40 is withdrawn, preventing blood from passing through the barrier formed by the seal 80 and the flow-blocking membrane 50. Specifically, the seal 80 is used to seal the connection hole 242 of the connector 240 and the through-hole or gap in the flow-blocking membrane 50. Preferably, the seal 80 is positioned on one side of the flow-blocking membrane 50 within the lumen of the sealing portion 24. In this embodiment, the seal 80 and the flow-blocking membrane 50 are adjacent to each other. In alternative embodiments, the seal 80 and the flow-blocking membrane 50 are spaced apart.

[0072] In this embodiment, the seal 80 is a circular hemostatic sponge dispersed with a hemostatic agent. The hemostatic sponge is fixed at the proximal end of the inner cavity of the sealing part 24 and is provided with a channel for the multi-electrode catheter 40 to pass through, and the channel is a slit; the channel of the seal 80 and the perforations on the flow-blocking membrane 50 are arranged in an alternating manner, that is, the slits of the hemostatic sponge and the perforations of the flow-blocking membrane 50 are arranged in an alternating manner, thereby preventing blood flow or blood clots and other substances from flowing out of the left atrial appendage to the left atrium through the perforations of the flow-blocking membrane 50 and the slits of the seal 80.

[0073] It should be noted that the flow-blocking film 50 in this embodiment can be any form of the barrier element mentioned above.

[0074] The distal section of the multi-electrode catheter is pre-shaped into a plurality of annular structures arranged along the axial direction. The distal section 42 of the multi-electrode catheter 40 is pre-shaped into a plurality of annular structures arranged along the axial direction, and the diameter of the annular structure closer to the distal end is smaller. In this embodiment, the multi-electrode catheter 40 is pre-shaped into a two-ring annular structure, and the diameter of the annular structure at the distal end is smaller than the diameter of the annular structure at the proximal end; specifically, the multi-electrode catheter 40 includes a proximal ring 421 and a distal ring 423 that are wound; the diameter of the proximal ring 421 is larger than the diameter of the distal ring 423. When the multi-electrode catheter 40 enters the left atrial appendage for ablation, the proximal ring 421 and the distal ring 423 can be arranged in a spiral shape to achieve a better annular ablation effect.

[0075] The multi-electrode catheter 40 is provided with an ablation component 30 and a mapping component 70. The ablation component 30 is an ablation electrode mounted on the carrier component 41 of the multi-electrode catheter 40. The mapping component 70 is a mapping electrode mounted on the carrier component 41 of the multi-electrode catheter 40. Both the ablation electrode and the mapping electrode can be ring electrodes. The ablation electrode is used to transmit ablation energy, and the mapping electrode is used to detect electrical signals. The multi-electrode catheter 40 is provided with a plurality of ablation electrodes and a plurality of mapping electrodes along its length. In this embodiment, the ablation electrodes and the mapping electrodes are arranged in an alternating manner, or in layers, that is, the mapping component 70 is provided on the distal ring 423, and the ablation component 30 is provided on the proximal ring 421. In this embodiment, the ablation electrode rings and the mapping electrode rings are arranged in an alternating manner along the extension direction of the carrier component 41.

[0076] In other embodiments, a circle of ablation electrode ring is provided on the proximal ring 421 of the multi-electrode catheter 40, and a circle of mapping electrode ring is provided on the distal ring 423 of the multi-electrode catheter 40; or a circle of mapping electrode ring is provided on the proximal ring 421 of the multi-electrode catheter 40, and a circle of ablation electrode ring is provided on the distal ring 423 of the multi-electrode catheter 40.

[0077] like Figure 7 As shown, in one embodiment, a sealing member 80 is disposed in the connecting hole 242 of the connector 240. Specifically, a swellable coagulation-blocking material is affixed to the inner wall of the connecting hole 242 of the connector 240. The coagulation-blocking material is fixed in the inner cavity of the connector 240 and fills the inner cavity of the connector 240. A gap 82 is provided in the middle of the sealing member 80 for the axial insertion of the inner sheath 60. After the inner sheath 60 is withdrawn from the connecting hole 242 of the connector 240, the gap 82 of the coagulation-blocking material can be elastically closed to prevent blood, blood clots and other substances from flowing out of the left atrial appendage into the left atrium.

[0078] like Figure 8 As shown, in one embodiment, the left atrial appendage occlusion device 100b includes an inner sheath 60 that is detachably connected to the occluding member 20, a multi-electrode catheter 40 is inserted into the inner cavity of the inner sheath 60, and the distal end of the multi-electrode catheter 40 is connected 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 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 60 reaches the designated ablation position, the multi-electrode catheter 40 is pushed out to prevent the distal end of the multi-electrode catheter 40 from being entangled with the occluding member 20, other parts of the multi-electrode catheter 40, or the target tissue when released, thereby ensuring that the multi-electrode catheter 40 is smoothly unsheathed and deformed in an annular shape. The distal end of the multi-electrode catheter 40 is fixed to the inner sheath 60, so that the head end of the multi-electrode catheter 40 is restricted when it returns to an annular shape, and also promotes the precise release of the multi-electrode catheter 40 in the designated area.

[0079] See also Figure 9 The structure of the left atrial appendage occlusion device 100c provided in the fourth embodiment of the present invention is similar to that of the third embodiment, except that the sealing member 80 in the fourth embodiment occupies a greater volume of the inner cavity of the occluding member 20a than the sealing member 80 in the third embodiment. Specifically, the sealing member 80 is a swellable coagulation-blocking material disposed within the inner cavities of the sealing portion 24 and the anchoring portion 22. The sealing member 80 is used to seal the occluding member 20a after the multi-electrode catheter 40 is withdrawn. Specifically, the sealing member 80 is used to seal the connection hole 242 of the connector 240 and the perforation in the flow-blocking membrane 50. Preferably, the coagulation-blocking material fills the inner cavities of the sealing portion 24 and the anchoring portion 22. In this embodiment, the coagulation blocking material is a circular hemostatic sponge dispersed with a hemostatic agent and provided with a slit for the multi-electrode catheter 40 to pass through. The slits of the hemostatic sponge and the perforations of the blocking membrane 50 are arranged alternately. After the multi-electrode catheter 40 is withdrawn, the hemostatic sponge and the blocking membrane 50 are superimposed and cooperated to prevent blood, blood clots and other substances from flowing out of the left atrial appendage to the left atrium.

[0080] See also Figure 10 , Figure 10 FIG2 is a schematic diagram of the structure 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 catheter 40a according to the fifth embodiment of the present invention differs from that of the first embodiment. The multi-electrode catheter 40a according to the fifth embodiment includes a plurality of support rods 45 arranged sequentially in a circumferential direction. Specifically, the multi-electrode catheter 40a is a frame structure formed by a circumferential arrangement of the support rods 45. The distal and proximal ends of the plurality of support rods 45 are joined together to form a lantern shape.

[0081] Specifically, the distal ends of the multiple support rods 45 converge and connect to a distal block 47, while the proximal ends of the multiple support rods 45 converge and connect to a connecting block 46. The middle portion of each support rod 45 is curved and convex outward, and the distal block 47 and the connecting block 46 can be retracted into the lumen of the inner sheath 60. By adjusting the axial distance between the distal block 47 and the connecting block 46, the maximum diameter of the multiple support rods 45 of the multi-electrode catheter 40b is adjusted, thereby improving the adhesion 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 morphologies and sizes.

[0082] The ablation element 30 is an ablation electrode circumferentially arranged on at least one circle of the multiple support rods 45, and the mapping element 70 is a mapping electrode circumferentially arranged on at least one circle of the multiple support rods 45. The distal end surface of the distal block 47 is spherical to prevent the multi-electrode catheter 40a from damaging the left atrial appendage tissue.

[0083] Preferably, on the multi-electrode catheter 40a, the mapping electrodes are arranged adjacent to the distal end of the ablation electrodes, that is, each ablation electrode is arranged adjacent to the middle of the corresponding supporting rod 45, and each mapping electrode is arranged adjacent to the distal end of the supporting rod 45 adjacent to the ablation electrode.

[0084] The multiple support rods 45 of the multi-electrode catheter 40a are arranged in sequence in the circumferential direction. In this embodiment, the multiple support rods 45 are evenly arranged in the circumferential direction of the distal block 47; the multi-electrode catheter 40a has 3-8 support rods 45. In this embodiment, the multi-electrode catheter 40a has 6 support rods 45.

[0085] Please also refer to Figure 11 and Figure 12 The structure of the multi-electrode catheter 40b provided in the sixth embodiment of the present invention is similar to the structure of the multi-electrode catheter 40a in the fifth embodiment, except that each supporting rod 45 extends spirally around the axial direction, and the marking component 70 on the multi-electrode catheter 40b is adjacent to the distal end of the multi-electrode catheter 40b relative to the ablation component 30.

[0086] Specifically, the proximal and distal ends of each supporting rod 45 are deflected in the circumferential direction by a preset angle, preferably, the preset angle is between 30 degrees and 70 degrees. That is, the multi-electrode catheter 40b is a multi-rod helical structure in the radial direction, such as Figure 11 As shown. When the distance between the distal block 47 and the connecting block 46 is relatively close, the supporting rods 45 of the multi-electrode catheter 40b will be compressed and elastically deformed into a flat shape similar to petals, so that the ablation electrodes and the mapping electrodes are more evenly distributed circumferentially in the multi-electrode catheter 40b. By adjusting the axial distance between the distal block 47 and the connecting block 46, the maximum diameter of the multiple supporting rods 45 of the multi-electrode catheter 40b is adjusted, thereby improving the adhesion 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, as well as Figure 12 shown.

[0087] Please also refer to Figures 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 member of the left atrial appendage occlusion device in the seventh embodiment is a closing mechanism 90 provided on the sealing portion 24. The closing mechanism 90 axially covers the proximal end of the sealing portion to prevent the leakage of blood, thrombus, etc. in the left atrial appendage. Specifically:

[0088] 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 axially arranged between the slot ring 91 and the rotating base 93 for the multi-electrode catheter 40 and the inner sheath tube 60 to pass through.

[0089] In this embodiment, the proximal end of the retaining ring 91 is fixedly connected to the inner wall of the connector 240. The rotating shaft 95 rotates relative to the retaining ring 91, thereby driving the rotating base 93 to rotate relative to the retaining ring 91, causing the plurality of closing pieces 94 to slide relative to the retaining ring 91 and the rotating base 93, thereby opening or closing the through hole 951.

[0090] The through hole 951 is open, which means that a plurality of closing pieces 94 are dispersedly arranged along the path of the through hole 951, and gaps are formed along the path of the through hole 951 between the plurality of closing pieces 94, so that the through holes 951 formed respectively by the groove ring 91 and the rotating base 93 are interconnected, facilitating the insertion of the multi-electrode catheter 40. The through hole 951 is closed, which means that a plurality of closing pieces 94 are concentratedly arranged along the path of the through hole 951 to form a barrier, so that the through holes 951 formed respectively by the groove ring 91 and the rotating base 93 are isolated from each other by the closing pieces 94 and are not interconnected to block blood flow. In this embodiment, the axes of the through holes 951 formed respectively by the groove ring 91 and the rotating base 93 coincide with each other. In other embodiments, the axes of the through holes 951 formed respectively by the groove ring 91 and the rotating base 93 are not limited to coincide with each other.

[0091] A plurality of closing pieces 94 are sandwiched between the retaining ring 91 and the rotating base 93 and are slidably connected to the retaining ring 91 and the rotating base 93. The retaining ring 91 has a plurality of extension strips 912 extending into its inner cavity. The rotating base 93 is provided with a plurality of guide grooves 932. One side of each closing piece 94 is slidably connected to a corresponding guide groove 932, and the other opposite side of each closing piece 94 is slidably connected to a corresponding extension strip 912. The rotating base 93 rotates relative to the retaining ring 91 to drive the plurality of closing pieces 94 to slide along the corresponding guide grooves 932 and extension strips 912, thereby opening or closing the through-hole 951.

[0092] In this embodiment, each extension bar 912 is provided with a guide groove 914 along its length. Each closing piece 94 is provided with a lever 942 slidably received within the corresponding guide groove 914 on the side facing the corresponding extension bar 912. The rotating base 93 rotates relative to the retaining ring 91 to drive the closing pieces 94 to slide along the corresponding guide groove 932 and the guide groove 914, thereby opening or closing the through-hole 951.

[0093] In other embodiments, each closing piece 94 is provided with a guide groove and a guide slide groove, and the extension bar 912 and the rotating base 93 are provided with a lever slidably accommodated in the corresponding guide groove or guide slide groove to realize the sliding connection between the closing piece 94 and the slot ring 91 and the rotating base 93.

[0094] like Figure 15 and Figure 16 As shown, in this embodiment, the rotating base 93 is provided with three guide grooves 932 around the through hole 951, and the three guide grooves 932 are connected end to end to form a triangle; the shift lever 942 is protruded at the guide groove 914 corresponding to each closing piece 94. Each closing piece 94 is pentagonal, and includes a sliding edge 943 corresponding to the guide groove 932, an extension edge 944 provided at opposite ends of the sliding edge 943, and two splicing edges 945 provided on the side of the two extension edges 944 away from the sliding edge 943; the closing piece 94 is provided with a guide bar (not shown) slidably accommodated in the guide groove 932 near the sliding edge 943. When the plurality of closing pieces 94 close the through hole 951, the two splicing edges 945 of each two adjacent closing pieces 94 fit together, as shown in FIG. Figure 15 When the plurality of closing pieces 94 open the through hole 951, the two adjacent closing pieces 94 of the two joint edges 945 are staggered to form a through hole 951 of the communication, such as Figure 16 In this embodiment, the rotating base 93 and the rotating shaft 95 are fixedly connected by welding or gluing.

[0095] Figure 16 and Figure 17 The direction of the arrow shown in the figure is the first direction, and the direction opposite to the first direction is the second direction. In specific use, the rotating shaft 95 drives the rotating base 93 to rotate in the first direction, so that each closing piece 94 slides along the corresponding guide groove 932 and the guide groove 914 and staggers with each other, so that the through hole formed by the staggered splicing edges 945 of these closing pieces 94 is connected to the through hole 951, so as to facilitate the insertion of the multi-electrode catheter. Figure 16 As shown; the rotating shaft 95 drives the rotating base 93 to rotate in the second direction, so that each closing piece 94 slides along the corresponding guide groove 932 and the guide groove 914 and gathers together, so that the corresponding splicing edges 945 of these closing pieces 94 fit together and close the through hole 951, so that the blood, thrombus, etc. in the left atrial appendage are omitted, as shown Figure 15 shown.

[0096] In this embodiment, the first direction is clockwise and the second direction is counterclockwise. In other embodiments, the first direction is counterclockwise and the second direction is clockwise.

[0097] like Figure 13 and Figure 17As shown, in this embodiment, the closing mechanism 90 further includes a rotating steel cable 97 and a handle (not shown) provided at the proximal end of the rotating steel cable 97. The handle is connected to the rotating steel cable 97 to control the rotation of the rotating steel cable 97. The distal end of the rotating steel cable 97 is connected to the rotating shaft 95 by a threaded connection. The proximal end of the groove ring 91 is provided with an extension tube 915 that surrounds the rotating shaft 95. A gap is provided between the rotating shaft 95 and the extension tube 915. The extension tube 915 is provided with at least one limiting groove 916 along its circumference. The rotating shaft 95 is provided with an elastic stopper 953 corresponding to the limiting groove 916. That is, the elastic stopper 953 can be slidably inserted into the limiting groove 916. The elastic stopper 953 is arranged at an angle. The limiting groove 916 is used to control the unidirectional rotation of the elastic stopper 953.

[0098] When the handle controls the rotating steel cable 97 to rotate in the first direction, the rotating steel cable 97 and the rotating shaft 95 are gradually tightened; when the rotating steel cable 97 and the rotating shaft 95 are tightened, when the rotating steel cable 97 drives the rotating shaft 95 to rotate in the first direction, several closing pieces 94 slide along the corresponding guide grooves 932 and extension strips 912 to open the through hole 951, and the elastic stop piece 953 moves and slides along the first direction; when the handle controls the rotating steel cable 97 to rotate in the second direction, the rotating steel cable 97 drives the rotating shaft 95 to rotate in the second direction, and several closing pieces 94 slide along the corresponding guide grooves 932 and extension strips 912 to close the through hole 951; when several closing pieces 94 close the through hole 951, when the rotating steel cable 97 rotates in the second direction, the threaded connection between the rotating steel cable 97 and the rotating shaft 95 gradually loosens.

[0099] In this embodiment, the outer wall of the rotating shaft 95 is uniformly provided with three elastic stoppers 953 along its circumference, and the outer wall of the extension tube 915 is provided with three limiting grooves 916 corresponding to the three elastic stoppers 953. When the rotating shaft 95 rotates in a first direction, the elastic stoppers 953 rotate without being stopped by the corresponding limiting grooves 916, thereby facilitating the movement of the closing pieces 94 away from each other and opening the through-hole 951. When the rotating shaft 95 rotates in a second direction, the elastic stoppers 953 rotate without being stopped by the corresponding limiting grooves 916. This ensures that the elastic stoppers 953 rotate at the same angle in the first and second directions, facilitating complete closure of the closing pieces 94 and avoiding the problem of blood flow channels between the closing pieces 94 not being fully closed due to different rotation angles of the elastic stoppers 953 in the first and second directions. After the closing pieces 94 converge to close the through-hole 951, continued rotation of the cable 97 in the second direction separates the cable 97 from the rotating shaft 95, facilitating its removal from the body.

[0100] The distal end of the rotating cable 97 is threadedly connected to the rotating shaft 95, and the thread release direction is consistent with the non-rotatable direction of the rotating shaft 95. When the passage between the closing pieces 94 is completely closed, the rotating cable 97 continues to rotate in the second direction to be untied from the thread of the rotating shaft 95, making it easier to withdraw from the body.

[0101] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A left atrial appendage occlusion device, characterized in that: The device comprises a multi-electrode catheter, an occluding member, an ablation member connected to the occluding member, and a mapping member, wherein the occluding member is used to be fixed at the opening of the left atrial appendage, the ablation member is used to transmit ablation energy to ablate a target tissue area in the left atrial appendage, and the mapping member is used to receive electrophysiological signals to map the target tissue area; The blocking member includes a sealing member, wherein the sealing member is provided with a channel for the multi-electrode catheter to pass through, and the channel is closed after the multi-electrode catheter is withdrawn from the channel; The sealing member includes a slot ring, a rotating base rotatably arranged 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 arranged 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, so that the plurality of closing pieces slide relative to the slot ring and the rotating base, thereby on the path of the through holes respectively formed by the slot ring and the rotating base, The plurality of closing pieces are dispersedly arranged with gaps formed therebetween, and the through holes respectively formed in the clamping ring and the rotating base are communicated with each other, thereby opening the through holes; or The plurality of closing pieces are centrally arranged to form a barrier, and the through holes respectively formed by the clamping ring and the rotating base are isolated from each other by the plurality of closing pieces, thereby closing the through holes.

2. The left atrial appendage occlusion device according to claim 1, characterized in that: The ablation component and / or the mapping component are detachably connected to the occluding component.

3. The left atrial appendage occlusion device according to claim 2, characterized in that: The blocking member is a hollow structure, the multi-electrode catheter is detachably inserted into the blocking member, the multi-electrode catheter includes a distal section at its distal end, and the mapping member is a plurality of mapping electrodes provided at the distal section of the multi-electrode catheter.

4. The left atrial appendage occlusion device according to claim 3, characterized in that: The distal end section of the multi-electrode catheter is used to extend out of the distal end of the occluding member so that the mapping electrodes contact the target tissue to receive electrophysiological signals.

5. The left atrial appendage occlusion device according to claim 3, characterized in that: The ablation component is a plurality of ablation electrodes arranged at the distal section, wherein the ablation electrodes and the mapping electrodes are spaced apart from each other at the distal section. The distal section is used to be accommodated in the inner cavity of the occluding component or to extend out of the distal end of the occluding component to transmit ablation energy to the target tissue area.

6. The left atrial appendage occlusion device according to claim 5, characterized in that: The distal section of the multi-electrode catheter is pre-shaped into at least one annular structure.

7. The left atrial appendage occlusion device according to claim 6, characterized in that: The distal end section of the multi-electrode catheter is pre-shaped into a plurality of annular structures arranged along the axial direction, and the diameter of the annular structure closer to the distal end is smaller.

8. The left atrial appendage occlusion device according to claim 5, characterized in that: The multi-electrode catheter includes a plurality of supporting rods sequentially arranged in a circumferential direction, and the distal ends and proximal ends of the plurality of supporting rods are respectively combined together.

9. The left atrial appendage occlusion device according to claim 8, characterized in that: At least one supporting rod extends helically around the axial direction.

10. The left atrial appendage occlusion device according to claim 5, characterized in that: On the multi-electrode catheter, the mapping electrode is disposed proximal to the distal end relative to the ablation electrode.

11. The left atrial appendage occlusion device according to claim 5, characterized in that: The multi-electrode catheter includes a carrier and a wire provided on the carrier. The ablation electrode and the mapping electrode are electrically connected to an ablation energy source and a mapping signal receiver respectively through the wire.

12. The left atrial appendage occlusion device according to claim 3, characterized in that: The ablation component is arranged on the blocking component.

13. The left atrial appendage occlusion device according to claim 12, characterized in that: The blocking member includes an anchoring portion and a sealing portion connected to the proximal end of the anchoring portion, and the ablation member is arranged on the surface of the anchoring portion.

14. The left atrial appendage occlusion device according to any one of claims 3 to 12, characterized in that: The blocking member includes an anchoring portion and a sealing portion connected to the proximal end of the anchoring portion. At least one flow-blocking membrane is provided in the sealing portion and / or the anchoring portion. The distal section of the multi-electrode catheter passes through the at least one flow-blocking membrane and is accommodated 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.

15. The left atrial appendage occlusion device according to claim 14, characterized in that: The flow-blocking membrane is elastic and includes a plurality of valve membranes arranged around the perforation, with gaps provided between adjacent valve membranes, and a perforation for the multi-electrode catheter to pass through formed between the valve membranes; when the multi-electrode catheter passes through the perforation, the plurality of valve membranes are squeezed and deformed to open the perforation, and after the multi-electrode catheter is withdrawn from the perforation, the plurality of valve membranes are reset to close the perforation.

16. The left atrial appendage occlusion device according to claim 14, characterized in that: The sealing member is arranged at the sealing portion and at one side of the flow-blocking membrane.

17. The left atrial appendage occlusion device according to claim 16, characterized in that: A connector is provided at the proximal end of the sealing portion. The connector is provided with a connecting hole along the axial direction for the multi-electrode catheter to pass through. The sealing member is arranged in the connecting hole.

18. The left atrial appendage occlusion device according to claim 17, characterized in that: The proximal end of the sealing portion is connected to a connector after being converged at the middle thereof, and the groove ring is connected to the connector.

19. The left atrial appendage occlusion device according to claim 18, characterized in that: The slot ring extends a plurality of extension strips toward its inner cavity, and the plurality of closing pieces are arranged between the plurality of extension strips and the rotating base. The rotating base is provided with a plurality of guide grooves, one side of each closing piece is slidably connected to the corresponding guide groove, and the other side opposite to each closing piece is slidably connected to the corresponding extension strip. The rotating base rotates relative to the slot ring to drive the plurality of closing pieces to slide along the corresponding guide grooves and extension strips.

20. The left atrial appendage occlusion device according to claim 19, characterized in that: The sealing member further includes a rotating steel cable and a handle, wherein the handle is connected to the rotating steel cable to control the rotation of the rotating steel cable, and a distal end of the rotating steel cable is connected to the rotating shaft via a thread; During the process of the rotating steel cable rotating in the first direction, the rotating steel cable and the rotating shaft are gradually tightened; when the rotating steel cable and the rotating shaft are tightened, the rotating steel cable drives the rotating shaft to rotate in the first direction, and the plurality of closing pieces slide along the corresponding guide grooves and extension strips to open the through hole; When the handle controls the rotating steel cable to rotate in the second direction, the rotating steel cable drives the rotating shaft to rotate in the second direction, and a plurality of closing pieces slide along the corresponding guide grooves and extension strips to close the through hole; when the through hole is closed by a plurality of closing pieces, the rotating steel cable and the rotating shaft gradually loosen during the rotation of the rotating steel cable in the second direction.

21. The left atrial appendage occlusion device according to claim 14, wherein: It also includes an inner sheath tube that is detachably connected to the occluding member, the multi-electrode catheter is inserted into the inner cavity of the inner sheath tube, the distal end of the multi-electrode catheter is connected to the distal end of the inner sheath tube, the distal end of the inner sheath tube passes through the at least one flow-blocking membrane and is inserted into the interior of the sealing part, the interior of the anchoring part or extends from the distal end of the occluding member, and the multi-electrode catheter extends from the distal end of the inner sheath tube and forms a ring.

22. The left atrial appendage occlusion device according to claim 21, characterized in that: The distal end of the inner sheath is fixedly connected to the distal end of the multi-electrode catheter.

Images