CN113116447A - Left auricle ablation plugging device - Google Patents

Abstract

The invention provides a left auricle ablation plugging device which comprises a supporting framework and an ablation piece arranged on the peripheral surface of the supporting framework, wherein a guide piece is arranged at the far end of the supporting framework, a connecting piece is arranged between the far end of the supporting framework and the guide piece, the connecting piece can swing relative to the axial lead of the supporting framework, the guide piece drives the connecting piece to bend until the ablation piece is attached to a proper position of the inner wall of the left auricle, the ablation piece is connected with an ablation energy source, and the ablation piece performs annular ablation on the inner wall of the left auricle.

Description

Left auricle ablation plugging device

Technical Field

The invention relates to the technical field of interventional medical instruments, and relates to a left atrial appendage ablation plugging device.

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.

The Left Atrial Appendage (LAA) is a small muscle pocket extending from the anterior lateral wall of the left atrium of the heart, and is not only the most prominent site for atrial fibrillation (atrial fibrillation) but also one of the critical areas for its occurrence and maintenance due to its special shape and structure. During a normal cardiac cycle, the left atrial appendage contracts with the left atrium to pump blood from the left atrial appendage, typically preventing blood from stagnating within the left atrial appendage. However, during cardiac cycles characterized by arrhythmias (e.g., atrial fibrillation), the left atrial appendage may not contract sufficiently, resulting in blood stagnation within the left atrial appendage. Stagnant blood within the left atrial appendage tends to clot and form a thrombus that falls out of the left atrial appendage and flows out of the heart blocking the vascular access that ultimately leads to embolic stroke and even death.

Some patients with atrial fibrillation benefit from active Left Atrial Appendage Isolation (LAAI). Such as atrial tachycardia, atrial flutter and atrial fibrillation. Energy is delivered from the ablation device to the endocardium and myocardial tissue. The delivered energy causes tissue scarring. The scar blocks the pulses emitted from within the tissue, thereby electrically disconnecting them or "isolating them from the heart. In some cases, the ablation procedure may thus provide for the restoration of a normal heart rhythm.

The position that present left atrial appendage occluder that has the function of melting can't melt the occluder according to the different forms of left atrial appendage, size adjustment left atrial appendage, consequently the position and the effect of difficult control ablation. In addition, abundant and thick pectinate muscles and small musculature are attached to the inner wall of the left auricle, and the anatomical morphology is complex, so that the stable plugging of the left auricle plugging device at the optimal position after release is difficult to guarantee by the existing left auricle ablation instrument.

Disclosure of Invention

The invention aims to provide a left atrial appendage ablation occlusion device stably released to a proper position, so as to ensure that the left atrial appendage ablation occlusion device is released to the optimal position in the left atrial appendage, so as to stably occlude an orifice of the left atrial appendage and enable ablation energy to form a complete at least one circle of ablation region on the inner wall of the left atrial appendage.

In order to solve the technical problem, the invention provides a left auricle ablation plugging device which comprises a supporting framework and an ablation piece arranged on the peripheral surface of the supporting framework, wherein a guide piece is arranged at the far end of the supporting framework, a connecting piece is arranged between the far end of the supporting framework and the guide piece, the connecting piece can swing relative to the axial lead of the supporting framework, the guide piece is inserted into the left auricle along the inner channel of the left auricle, the guide piece drives the connecting piece to bend until the ablation piece is attached to the proper position of the inner wall of the left auricle, the ablation piece is connected with an ablation energy source, and the ablation piece performs annular ablation on the inner wall of the left auricle.

The far end of the supporting framework of the left atrial appendage occlusion device is connected with a guide piece through a connecting piece, and the guide piece can swing relative to the axis of the supporting framework. Therefore, in the process of implanting the left auricle ablation plugging device into the inner cavity of the left auricle, the supporting framework can enter the inner cavity of the left auricle with irregular shape more smoothly under the guiding action of the guiding piece, so that the supporting framework can be stably released to the optimal position, the inner cavity of the left auricle can be stably plugged, and the implantation efficiency of the left auricle plugging device is improved.

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 it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

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

figure 2 is an enlarged partial view of the left atrial appendage occlusion device of figure 1;

figure 3 is a schematic structural view of a left atrial appendage occlusion device provided in accordance with a second embodiment of the present invention;

figure 4 is an exploded schematic view of the left atrial appendage occlusion device of figure 3;

figure 5 is a schematic view of the left atrial appendage occlusion device of figure 3 in one of its states of use;

figure 6 is a schematic view of the left atrial appendage occlusion device of figure 3 in use;

figure 7 is a schematic structural view of a left atrial appendage occlusion device provided in accordance with a third embodiment of the present invention;

figure 8 is an enlarged partial view of the left atrial appendage occlusion device of figure 7;

figure 9 is a schematic view of a lead configuration of a left atrial appendage occlusion device provided in accordance with a fourth embodiment of the present invention;

FIG. 10 is a schematic structural diagram of a left atrial appendage occlusion device provided by a fifth embodiment of the invention

Figure 11 is a schematic structural view of the annular frame and the guide of a left atrial appendage occlusion device provided in accordance with a sixth embodiment of the present invention;

figure 12 is a schematic structural view of the ring frame and the guide of the left atrial appendage occlusion device of the seventh embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, the "proximal end" refers to the end relatively close to the operator during the operation, and the "distal end" refers to the end relatively far from the operator during the operation. Axial refers to the direction of the central axis of the device, and radial is the direction perpendicular to the central axis, and this definition is for convenience only and should not be construed as limiting the 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 and 2, the present invention provides a left atrial appendageablation occlusion device 100, which includes asupport frame 20, anablation element 40 disposed on an outer peripheral surface of thesupport frame 20, and aguide element 70 disposed at a distal end of thesupport frame 20, wherein a connectingelement 72 is disposed between the distal end of thesupport frame 20 and theguide element 70, the connectingelement 72 can swing relative to an axial line of thesupport frame 20, theguide element 70 is inserted into the left atrial appendage along an inner channel of the left atrial appendage, theguide element 70 drives the connectingelement 72 to bend until theablation element 40 is attached to an appropriate position of an inner wall of the left atrial appendage, so that theablation element 40 is completely attached to the inner wall of the left atrial appendage, theablation element 40 is connected with an ablation energy source, and theablation element 40 is used for performing annular ablation on the inner wall of the left. The ablatingmember 40 is an ablation electrode that surrounds at least one turn in the circumferential direction of thesupport frame 20.

In this embodiment, the supportingframework 20 is formed by cutting and shaping a nickel-titanium alloy tube, and the supportingframework 20 is a "water drop" or "Mongolian" metal cutting stent in a completely released state; theguide part 70 is a hollow diamond-like structure, the radial dimension of the diamond-like structure is not more than 10mm, so that the guide part can reach the bottom of the left auricle along the inner wall of the left auricle, and theguide part 70 has a deviation rectifying and guiding function; the connectingpiece 72 is the latch closure connecting portion of active connection tube structure, as shown in fig. 2, the connectingpiece 72 includes two rings of cutting fashioned latch closures circle, leaves the space ground to seal and detain together, has both guaranteed the stability that guidingpiece 70 is connected withsupport chassis 20 and has guaranteed the flexibility that guiding piece andsupport chassis 20 are connected for guidingpiece 70 has preceding, back, left and right, upper and lower diversified dislocation swing, increases the flexibility of direction function. In other embodiments, the connectingmember 72 can be a rotating shaft structure, a circular ring structure, a universal joint structure, a snap structure, a ball bearing structure, or the like.

The distal end of thesupport frame 20 of the left atrialappendage occlusion device 100 of the present invention is connected to theguide 70 by aswingable connection 72, so that theguide 70 can swing with respect to the axis of thesupport frame 20. Therefore, in the process of implanting the left atrial appendageablation occlusion device 100 into the inner cavity of the left atrial appendage, thesupport framework 20 can enter the inner channel of the left atrial appendage with an irregular shape more smoothly under the guiding action of the guidingelement 70, so that thesupport framework 20 can be stably released to an optimal position, thereby stably occluding and enabling theablation element 40 to be completely attached to the inner wall of the left atrial appendage, and improving the implantation efficiency of the left atrialappendage occlusion device 100.

As shown in fig. 1, thesupport frame 20 is a self-expanding device, and thesupport frame 20 may be a resilient metal support frame or a resilient non-metal support frame. When the left atrialappendage occlusion device 100 is delivered through a sheath, the diameter of thesupport scaffold 20 may be contracted to a smaller state for delivery within the sheath; when the left atrialappendage occlusion device 100 is released in the heart, theguide member 70 guides thesupport frame 20 to smoothly enter the proper position in the inner cavity of the left atrial appendage, and thesupport frame 20 can be automatically expanded and theablation member 40 on the outer wall of thesupport frame 20 can be completely attached to the inner wall of the opening of the left atrial appendage by adjusting the radial dimension of the support frame.

The supportingframework 20 can also be woven by silk material, or processed by combining local weaving with local tube cutting, and different parts can be welded or fixed with each other through connecting pieces. The tube is made of metal or nonmetal materials, the metal materials are preferably memory metal materials, and are preferably nickel-titanium alloy materials. The overall shape of thesupport frame 20 may be any suitable shape such as a straight cylinder, a disk, a cone, etc., and is not limited herein. The supportingskeleton 20 is provided with at least one blocking member for blocking blood flow, and preferably, the blocking member is aflow blocking film 50. The flow-blockingmembrane 50 may be disposed at the distal end and/or the proximal end of thesupport frame 20; or the flow-blockingmembrane 50 may be disposed in the lumen of thesupport frame 20. The flow-blockingmembrane 50 is attached to thesupport frame 20 by sewing or heat-pressing. Theflow blocking film 50 is a PET film or a PTFE film. In this embodiment, the flow-blockingmembrane 50 is disposed at the proximal end of the supportingframework 20, and the flow-blockingmembrane 50 is sealed at the opening of the left atrial appendage to prevent blood from flowing into the inner cavity of the left atrial appendage.

In this embodiment, in a state where the supportingframe 20 is completely released, the supportingframe 20 includes acylindrical sealing portion 23, ananchoring portion 25 disposed at a distal end of thesealing portion 23, and afurling portion 26 disposed at a proximal end of the sealingportion 23, the connectingmember 72 and the guidingmember 70 are disposed at a distal end of theanchoring portion 25, and theouter cable connector 24 is disposed at a proximal end of thefurling portion 26. Theouter cable connector 24 is used for detachably connecting with an outer cable pipe of theconveying support framework 20. The sealingportion 23 is located at the maximum radial dimension of the supportingframe 20, i.e., the radial dimension of thesealing portion 23 is greater than the radial dimension of theanchoring portion 25 and the radial dimension of theconverging portion 26, and the ablatingmember 40 is disposed on the sealingportion 23. When the supportingframework 20 is implanted into the inner cavity of the left atrial appendage, the sealingpart 23 is supported on the inner wall of the left atrial appendage, and theablation part 40 is attached to the inner surface of the left atrial appendage. Thesealing part 23 is formed by a plurality of prismatic frames which surround a circle along the circumference of the supportingframework 20, the near end of theanchoring part 25 is connected with the far end of thesealing part 23, and the far end of theanchoring part 25 is obliquely converged towards the middle part and the far end and then is fixedly connected with the innersteel cable connector 22; the far end of thefurled part 26 is connected to the near end of thesealing part 23, and the near end of thefurled part 26 is inclined towards the middle part and the near end and then fixedly connected to theouter cable connector 24.

The anchoringportion 25, the gatheringportion 26, and the sealingportion 23 constitute a metal-woven or cut net-like structure, a rod-like structure, or a frame structure. Specifically, as shown in fig. 1, the sealingportion 23 is formed by a corrugated annular structure and a plurality of connectingstrips 230, the corrugated annular structure is circumferentially arranged and is connected to two circles of gaps, the corrugated annular structure is axially spaced, and the connectingstrips 230 are respectively connected to the wave troughs and the corresponding wave crests of the corrugated annular structure. The proximal end of the anchoringportion 25 is connected to the crest of the distal wavy annular structure, and the distal end of thefurling portion 26 is connected to the trough of the proximal wavy annular structure. In this embodiment, each ring of the wave-shaped ring structure is formed by sequentially arranging and connecting a plurality of V-shaped supporting rods end to end, each wave-shaped ring structure includes awave crest 231, awave trough 233 andwave rods 235, thewave rods 235 adjacent in the circumferential direction are connected at the far end to form thewave crest 231, and thewave rods 235 adjacent in the circumferential direction are connected at the near end to form thewave trough 233. The proximal end of the anchoringportion 25 is connected to thecrest 231 of the distal wavy annular structure, and the distal end of the convergingportion 26 is connected to thetrough 233 of the proximal wavy annular structure. In this embodiment, the ablatingmember 40 is disposed on the outer wall of the proximal undulating annular structure.

At least one circle of anchoringthorns 252 are arranged on the outer surface of the supportingframework 20 along the circumferential direction, and the anchoringthorns 252 are adjacent to theablation piece 40 and are turned outwards; preferably, the number of at least one ring of anchoringstuds 252 is between 8 and 16. Specifically, a ring ofanchors 252 is circumferentially disposed between the sealingportion 23 and the anchoringportion 25 of thesupport frame 20, eachanchor 252 being a hook open toward the proximal end. The outer wall of the supportingframework 20 is provided with the anchoringthorn 252, when the supportingframework 20 is implanted into the inner cavity of the left atrial appendage, the anchoringthorn 252 can penetrate into the inner wall of the left atrial appendage, so that the whole pluggingdevice 100 is anchored in the left atrial appendage without falling off, and meanwhile, theconveyor 60 is convenient to recover.

The outer surface of the supportingframework 20 is provided with at least one circle of developing points or developing wires along the circumferential direction, in this embodiment, a plurality of developingpoints 232 are arranged on the sealingportion 23 adjacent to theablation piece 40, the developingpoints 232 surround the sealingportion 23 into a circle along the circumferential direction, and the developingpoints 232 are fixed in a manner of embedding and hot pressing. Specifically, one of each two adjacent connectingstrips 230 is provided with avisualization point 232 adjacent to one end of the ablatingmember 40. Preferably, the number of the plurality ofdevelopment sites 232 is between 8-16.

In other embodiments, one of thewave crest 231, thewave trough 233 and thewave rod 235 of each wave-shaped ring structure is provided with a circle of developing points on the sealingportion 23; or two of thewave crest 231, thewave trough 233 and thewave rod 235 are provided with developing points so as to enclose two circles of spaced developing points on the sealingpart 23; or thewave crest 231, thewave trough 233 and thewave rod 235 are all provided with developing points so as to enclose three circles of spaced developing points on the sealingpart 23, thereby facilitating the positioning of the sealingpart 23 in the inner cavity of the left atrial appendage. The developing point can be made of gold, platinum, tantalum and other materials.

In other embodiments, at least one circle of flexible developing wire is disposed on the sealingportion 23, and the developing wire is fixed by winding, embedding, and hot pressing.

In this embodiment, the ablation energy source is a radio frequency ablation source and the ablatingmember 40 is configured as an ablation electrode. Specifically, the supportingframework 20 is made of a conductive material, and a part of the supportingframework 20 can be directly used as the ablatingpart 40, and preferably, one circle of the outer peripheral surface of the supportingframework 20 where the radial dimension is largest is set as the ablatingpart 40. Theablation part 40 is a part of the surface of themetal supporting framework 20 which is not subjected to insulation treatment, namely at least one circle of the outer peripheral surface of the sealingpart 23 is an electrical exposed area; preferably, the outer peripheral surface of the wavy annular structure at the proximal end of the sealingportion 23 is provided as an ablation electrode, i.e., the surface of the supportingframe 20 is insulated except for the outer peripheral surface of the wavy annular structure at the proximal end. Only the metal on the outer peripheral surface of the wave-shaped annular structure at the near end is exposed, so that a circle of continuous wave-shaped ablation electrode can be formed. The outer surface of the supportingframework 20 except the outer peripheral surface of the near-end wave-shaped annular structure is insulated to prevent the other outer surfaces from contacting blood and conducting electricity, so that impedance is reduced, and complete annular ablation on the inner wall of the left atrial appendage cannot be completed. The ablatingmember 40 may be coupled to an ablation energy source via theouter cable connector 24.

The insulation treatment may be to coat the outer surface of the supportingframework 20 with an insulating coating or to thread an insulating sleeve on the supporting framework. Further, the insulating coating is a parylene insulating coating, and the insulating sleeve can be FEP or ETFE or PFA or PTFE sleeve. Because thesupport frame 20 is itself electrically conductive, the RF power source can be directly connected through an external lead to deliver RF energy to the ablatingmember 40 for further concentrating the energy on the tissue against which the ablatingmember 40 is engaged.

In other embodiments, the supportingframe 20 is a metal cutting supporting frame, and the surface of the supportingframe 20 except the outer surface of the connectingstrip 230 is subjected to insulation treatment, so that the outer surface of the connectingstrip 230 serves as an ablation piece; or the surface of the supportingframework 20 except the outer surfaces of the connectingstrips 230 and the proximal wavy annular structures is subjected to insulation treatment, so that the outer surfaces of the connectingstrips 230 and the proximal wavy annular structures are used as ablation pieces.

In other embodiments, the ablatingmember 40 may be a wire electrode disposed on the sealingportion 23, the wire electrode is electrically connected to the rf power source through an external conducting wire, and in order to concentrate the rf energy on the wire electrode, an insulation treatment, an insulation layer, or an insulation film or an insulation sleeve wrapped around the wire electrode at a position where the wire electrode contacts the sealingportion 23 may be performed.

In other embodiments, the supportingframework 20 may also be a supporting frame made of non-conductive material, and the ablatingmember 40 is a ring-shaped electrode that is circumferentially disposed at least one continuous or discontinuous turn along the outer surface of the sealingportion 23 of the supportingframework 20; or the ablation part 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 sealingpart 23 of the supportingframework 20. In other embodiments, ablatingmember 40 is a wire electrode disposed in a single or multiple continuous loops along the circumference ofsupport frame 20; the electrode wires are connected to the supportingframework 20 through winding, welding or pressing; and the outer surface of the supportingframework 20 is subjected to insulation treatment in a manner that an insulation coating is coated on the outer surface of the supportingframework 20, or an insulation sleeve is sleeved on the supportingframework 20, or an insulation film is coated on the supportingframework 20. 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 film is connected with the annular framework through sewing, hot pressing, spraying or dipping.

In other embodiments, the source of ablative energy may also be any of microwaves, ultrasound, pulses, cryogens, or chemical ablators.

In other embodiments, the ablatingmember 40 is disposed in a single or multiple continuous loops along the circumference of thesupport frame 20. Theguide 70 is a curved structure having an axial supporting force and a radial deforming force to slidably fit against the inner wall of the left atrial appendage; alternatively, theguide 70 is a curved structure having a distal end that prevents trauma to the inner wall of the left atrial appendage, and theguide 70 is used to guide the left atrialappendage occlusion device 100 into the left atrial appendage.

In this embodiment, as shown in fig. 1 and 2, the guidingelement 70 is disposed at the distal end of the anchoringportion 25, and the supportingframe 20, the connectingelement 72 and the guidingelement 70 are a cutting stent formed by cutting and shaping a nitinol tube. Theguide 70 is a hollow, lattice-cut diamond-like stent that is cut extending from the distal end of the cutting stent. Specifically, the guidingmember 70 is a metal laser-cut hollow diamond-like balloon structure, the radial diameter of which is not more than 10mm, and the guiding member can reach the bottom of the left atrial appendage along the inner wall of the left atrial appendage, so that the left atrialappendage occlusion device 100 keeps good centering performance, the left atrialappendage occlusion device 100 is prevented from deviating in the left atrial appendage at a large angle, and anchoring and occlusion of the left atrialappendage occlusion device 100 are stable and ablation can be continuous in a ring shape.

In other embodiments, theguide 70 may be a nickel titanium wire mesh ellipsoid stent, an everted hemispherical metal cutting stent, an inverted drop-shaped metal stent or a diamond-like stent, or the like.

Theguide member 70 is pivotally connected to the distal end of theinner cable connector 22 by alink 72, and thelink 72 is pivotally movable relative to the axial direction to pivot theguide member 70 relative to the axis of theinner cable connector 22 to facilitate insertion of theguide member 70 along the inner wall of the left atrial appendage into the interior of the left atrial appendage.

The distal end of theconnector 72 may be welded, sewn or otherwise attached to theguide 70; or the distal end of the connector is of unitary metal construction with theguide 70; the near end of the connectingpiece 72 is welded, sewed or attached to the far end of the supportingframework 20; or the proximal end of the connector may be of unitary metal construction with thesupport frame 20.

In this embodiment, the connectingmember 72 includes two cutting rings with enough space between them to make the connectingmember 72 swing in at least 4 or 8 directions, and the proximal end of the connectingmember 72 is welded to the distal end of the supportingframe 20 to provide more angle changes between the guidingmember 70 and the supportingframe 20, so as to increase the flexibility of the guiding function.

The left atrialappendage occlusion device 100 can be smoothly and quickly implanted into the inner cavity of the left atrial appendage under the guiding action of the flexibly connected guidingpiece 70, can be well centered, ensures that the left atrialappendage occlusion device 100 is implanted to a proper position, and enables theablation piece 40 to be effectively attached to the inner wall of the left atrial appendage so as to achieve the expected annular continuous ablation effect

The distal end of thesupport framework 20 of the left atrial appendageablation occlusion device 100 of the present invention is connected to aguide member 70 through aswingable connection member 72, and theguide member 70 can swing with respect to the axis of thesupport framework 20. Therefore, in the process of implanting the left atrial appendageablation occlusion device 100 into the inner cavity of the left atrial appendage, thesupport framework 20 can enter the inner cavity of the left atrial appendage with irregular shape more smoothly under the guiding action of the guidingpiece 70, so that thesupport framework 20 can be stably released to the optimal position, and the implantation efficiency of the left atrialappendage occlusion device 100 is improved. In addition, theinner cable 62 and theouter cable tube 64 of thedelivery device 60 are relatively moved in the axial direction by manipulating thedelivery device 60 during the operation to adjust the axial dimension and the radial dimension of thesupport frame 20 so that theablation member 40 completely fits the inner wall of the left atrial appendage, and at least one complete circle of ablation region can be formed on the inner wall of the left atrial appendage to achieve one complete circle of electrical isolation, thereby treating atrial fibrillation.

Referring to fig. 3 to 5 together, the structure of a left atrialappendage occlusion device 100a provided by a second embodiment of the invention is similar to that of the first embodiment, except that the structure of theguide member 70a of the left atrialappendage occlusion device 100a and the structure of the connectingmember 72a between theguide member 70a and thesupport frame 20 in the second embodiment are different from those in the first embodiment. Specifically, in the second embodiment, theguide 70a is a metal laser-cut hollow balloon stent, and preferably, theinner cable connector 22 and theguide 70a are cut stents formed by cutting and shaping a nitinol tube; theguide 70a is a hollow grid cut spherical stent that is cut extending from the distal end of the cutting stent. The radial diameter of the saccule support is not more than 10mm, and the saccule support can reach the bottom of the left auricle along the inner wall of the left auricle, so that the leftauricle plugging device 100a can be quickly and accurately implanted into a proper position in the left auricle, the leftauricle plugging device 100a can keep better centering performance, the leftauricle plugging device 100a is prevented from deviating in the left auricle at a larger angle, and the anchoring and plugging of the leftauricle plugging device 100a are stable and can be in annular continuity in ablation.

In this embodiment, theconnection 72a between theguide 70a and thesupport frame 20 is a hypotube, and theconnection 72a can swing in at least two directions, which are opposite in direction. Preferably, the connectingmember 72a has at least 2 or 4 directions of oscillation, and the proximal end of the connectingmember 72a is welded to the distal end of thesupport frame 20 to increase the flexibility of the guiding function.

In this embodiment, the proximal end of theconnector 72a is provided with aninner cable connector 22, and in particular, the inner wall of the proximal end of theconnector 72a is provided with threads for threaded connection with a cable. The left atrialappendage occlusion device 100a in this embodiment needs to be matched with aconveyor 60 when in use, theconveyor 60 comprises aninner steel cable 62 and an outersteel cable tube 64, and theinner steel cable 62 is inserted into the inner cavity of the outersteel cable tube 64; theinner cable 62 is axially movable relative to theouter cable tube 64 and is capable of spinning within theouter cable tube 64. The distal end of theinner cable 62 is detachably connected to theinner cable connector 22, the distal end of theouter cable tube 64 is detachably connected to theouter cable connector 24, and theinner cable 62 and theouter cable tube 64 are axially moved relative to each other, so that the radial dimension of thesupport frame 20 can be changed. Specifically, theinner cable 62 moves relative to theouter cable tube 64 in the axial direction, and when theinner cable connector 22 and theouter cable connector 24 are close to each other in the axial direction, the axial dimension of thesupport frame 20 decreases, and the radial dimension increases; when theinner cable connector 22 and theouter cable connector 24 are axially away from each other, the axial dimension of thesupport frame 20 increases and the radial dimension decreases.

The distal end of thesupport frame 20 of the left atrialappendage occlusion device 100a of the present invention is connected to theguide 70 by aswingable connection 72a so that theguide 70a can swing with respect to the axis of thesupport frame 20. Therefore, in the process of implanting the left atrial appendageablation occlusion device 100a into the inner cavity of the left atrial appendage, thesupport framework 20 can enter the inner channel of the left atrial appendage with an irregular shape more smoothly under the guiding action of the guidingelement 70a, so that thesupport framework 20 can be stably released to an optimal position, thereby stably occluding and enabling theablation element 40 to be completely attached to the inner wall of the left atrial appendage, and improving the implantation efficiency of the left atrialappendage occlusion device 100. In addition, since the radial dimension of the supportingframework 20 can be adjusted, the left atrialappendage occlusion device 100a can adjust the dimension of the left atrialappendage occlusion device 100a according to the shape and the opening dimension of the inner channel of the left atrial appendage, thereby conveniently controlling the ablation position of theablation member 40, so as to form at least one complete circle of ablation region in the inner channel of the left atrial appendage to achieve complete electrical isolation treatment effect.

As shown in fig. 4, in this embodiment, theinner cable connector 22 is connected to theinner cable 62 through a screw structure, and theouter cable connector 24 is connected to theouter cable tube 64 through a screw structure. The far end of theinner steel cable 62 is provided with an external thread matched with the internal thread of the innersteel cable connector 22; theouter cable connector 24 is provided with internal threads, and the distal end of theouter cable tube 64 is provided with external threads which are matched with the internal threads of theouter cable connector 24. Specifically, a connectinghole 221 is formed in the proximal end of the innersteel cable connector 22 along the axial direction, and an internal thread is formed in the inner circumferential surface of the connectinghole 221 of the innersteel cable connector 22; theinner steel cable 62 is a flexible pipe body with a closed far end, the far end of theinner steel cable 62 is provided with a connectingcolumn 621 in a protruding mode along the axial direction, and the outer peripheral surface of the connectingcolumn 621 is provided with an external thread matched with the internal thread of the innersteel cable connector 22. The outersteel cable connector 24 is a hollow pipe body, theinner steel cable 62 is movably inserted into an inner cavity of the outersteel cable connector 24, internal threads are arranged at the near end of the inner peripheral surface of the outersteel cable connector 24, the near end of thefurling part 26 is connected to the periphery of the near end of the pipe body, the outersteel cable pipe 64 is a hollow flexible pipe body, and external threads matched with the internal threads of the outersteel cable connector 24 are arranged on the outer peripheral surface of the far end of the outersteel cable pipe 64. The proximal end of theouter cable connector 24 is convex proximally, i.e. theouter cable connector 24 extends proximally in the axial direction.

Referring to fig. 5, after the left atrial appendageablation occlusion device 100a is released, the axial length of thesupport frame 20 can be adjusted by pulling theinner wire cable 62 while holding theouter wire cable 64 still, the radial diameter can be increased by shortening the axial distance due to the diamond-shaped nature of thesupport frame 20 in the form of "water drops" or "Mongolian bags", and the desired radial diameter of the left atrialappendage occlusion device 100 can be adjusted by varying the length of the pulledinner wire cable 62 to enable theablation member 40 of the left atrialappendage occlusion device 100 to be attached more tightly to the left atrial appendage.

In this embodiment, as shown in fig. 5 and 6, theinner cable 62 is further provided with aperfusion channel 622 along the axial direction, and the outer wall of theinner cable 62 near the proximal end is provided with at least one circle of sprayingholes 623 communicating with theperfusion channel 622 along the circumferential direction. Preferably, the outer peripheral wall of theinner cable 62 is axially provided with 1-4 circles of circumferentially and uniformly distributedspray holes 623, and the number of the spray holes 623 is between 4-16. When theinner steel cable 62 is connected to the innersteel cable connector 22, the outersteel cable pipe 64 is connected to the outersteel cable connector 24, the supportingframework 20 is completely released, the spraying holes 623 of theinner steel cable 62 are located in the inner cavity of the supportingframework 20, the spraying holes 623 are opposite to theablation piece 40, when theablation piece 40 ablates the left auricle, cooling liquid is sprayed onto theablation piece 40 or tissues near theablation piece 40 from the sprayingholes 623 after theperfusion channel 622 of theinner steel cable 62, the ablation area of the left auricle can be uniformly cooled, eschar is prevented, and the ablation depth can be increased.

After the ablation of theablation part 40 is completed in the channel, the left atrial appendageablation occlusion device 100a enables thesupport framework 20 to be anchored in the left atrial appendage in a natural state by adjusting theinner steel cable 62 or the outersteel cable pipe 64, releases the connection between the innersteel cable connector 22 and the outersteel cable connector 24 and theinner steel cable 62 and the outersteel cable pipe 64 after confirming that the occlusion is stable, and withdraws theconveyor 60, as shown in fig. 6, only thesupport framework 20, the connectingpart 72a and the guidingpart 70a are left in the left atrial appendage to play a role in occluding the orifice of the left atrial appendage and preventing thrombus from falling out.

Referring to fig. 7 and 8, a left atrialappendage occlusion device 100b provided in a third embodiment of the present invention has a structure similar to that of the second embodiment, except that the structure of theguide member 70b and the connection manner of theconnection member 72a and thesupport frame 20 in the third embodiment are different from those in the first embodiment, as follows: the proximal end of theguide 70b of the left atrialappendage closure device 100b is welded to the distal end of theconnector 72a, and the proximal end of theconnector 72a is welded to the distal end of theinner wire cable 62. Theguide 70b is a metal cut, everted hemispherical structure, open towards the proximal end and curled inward. So that the guidingelement 70b can penetrate into the bottom of the left atrial appendage without damaging the inner wall of the left atrial appendage, and after the deviation-correcting guiding function is completed, the guidingelement 70b and the connectingelement 72a can be retracted into the outersteel cable tube 64 under the retraction of theinner steel cable 62, and further can be withdrawn out of the body together with the outersteel cable tube 64.

The connection 72b connects between theguide 70a and theinner cable 62 so that theguide 70a has a certain angular swing, increasing the flexibility of the guiding function.

The left atrialappendage occlusion device 100b of the third embodiment reduces the number of components left in the patient after the procedure is completed, leaving only thesupport framework 20 to occlude the left atrial appendage cavity, reducing the risk after the procedure.

The other structures of the left atrial appendage occlusion device in the third embodiment are the same as those in the second embodiment, and are not described herein again.

Referring to fig. 9, a fourth embodiment of the present invention provides a left atrial appendage occlusion device having a structure similar to that of the third embodiment, except that the fourth embodiment has a structure in which aguide member 70c and a connectingmember 72c are provided; specifically, in the fourth embodiment, theguide 70c is a wire-braided guide ball, and theguide 70c is connected to theinner cable 62 by a connectingmember 72 c; preferably, theconnector 72c and guide 70c at the distal end of theinner cable 62 are adapted to pass through the inner cable connector and the outer cable connector and to be withdrawn with theinner cable 62. Specifically, theconnector 72c is a metal braided tube integrally braided with theguide 70 c. The metal wires are woven into elastic shape memory alloy nickel titanium wires, so that theguide piece 70c and the connectingpiece 72c have good flexibility, the guiding function is enhanced, and the implantation balance and stability of the adjustable left atrial appendage occlusion device are improved.

The other structures of the left atrial appendage occlusion device in the fourth embodiment are the same as those in the third embodiment, and are not described herein again.

Referring to fig. 10, a left atrialappendage occlusion device 100c according to a fifth embodiment of the present invention has a structure similar to that of the second embodiment, except that a structure of asupport frame 20a in the fifth embodiment is different from that of the second embodiment, as follows: the proximal end of the supportingframework 20a is a metal cutting stent in a shape of a 'straw hat', and the distal end is a hollow saccule stent, which are connected by a connectingpiece 72 a. Thesupport framework 20a comprises an anchoringportion 25a located at the far end, a sealingportion 23a located at the near end and anablation portion 27 located between the anchoringportion 25a and the sealingportion 23a, an innersteel cable connector 22 is arranged at the far end of the anchoringportion 25a, an outersteel cable connector 24 is arranged at the near end of the sealingportion 23a, the innersteel cable connector 22 is detachably connected with the far end of an inner steel cable, and the outersteel cable connector 24 is detachably connected with an outer steel cable pipe.

The supportingframework 20a of the straw hat type is divided into a cone frame from the far end to the near end, a truncated cone frame and a circle of flanges form a hat brim which protrudes outwards.

The anchoringportion 25a includes the cone frame, the truncated cone frame, and 8-16 everted anchors 252 uniformly arranged in the circumferential direction at the outer distal end of the truncated cone frame. Theanchor 252 enables the entire left atrialappendage closure device 100c to fit tightly within the left atrial appendage without falling off, while facilitating the retrieval of the inner and outer steel cables. The distal end ofanchor portion 25a is towards the middle part and is buckled to the near-end for the distal end of interiorsteel cable connector 22 is the turn-up structure, thereby the distal end ofsupport skeleton 20a that can avoid is sharp-pointed gradually, in order to prevent that sharp-pointed distal end from stabbing left atrial appendage inner wall, has also reduced simultaneously the whole height of left atrial appendageablation plugging device 100 a.

Sealing portion 23a includes the flange frame of metal cutting support "brim of a hat" position, the radial diameter of flange is greater than the radial diameter of cone frame and round platform body frame, sealingportion 23a inside is equipped with at least one deck and hinders the flow film (not shown in the picture), is convenient for block up left auricle drill way, prevents remaining reposition of redundant personnel. The sealingportion 23a is further provided with a circle of developingpoints 232 for facilitating medical imaging.

Theablation piece 40 is arranged on a flange at the position of a hat brim at the far end of the straw hat-shaped metal cutting support, can be tightly attached to an ablation area on the inner wall of the auricle, and improves the ablation effect. In this embodiment, the ablatingmember 40 is a bare metal frame on thesupport frame 20a that can be connected to a radio frequency power source. Thesupport framework 20a is used as the outer surface of the metal outside the metal frame of theablation piece 40 for insulation treatment, and the insulation treatment mode comprises coating an insulation coating, coating an insulation film or inserting an insulation sleeve.

Referring to fig. 11, a left atrialappendage occlusion device 100d according to a sixth embodiment of the present invention has a structure similar to that of the first embodiment, except that the structures of the supportingframework 20b and the connectingmember 72d in the sixth embodiment are different from those of the first embodiment, as follows:support chassis 20b is the elastic metal wire woven frame of cylinder type, the distal end of metal woven frame is provided with theguide piece 70 that is formed by nickel titanium alloy tubular product cutting design, and guidepiece 70 is hollow class diamond-shaped support, the near-end ofguide piece 70 with connect through connectingpiece 72d between the distal end middle part of metal woven frame, the near-end welding of connectingpiece 72d the distal end of metal woven frame.

The supportingframework 20b is a hollow structure, and comprises an anchoringpart 25b at the far end, a sealingpart 23b at the near end, and anablation part 27 connected between the anchoringpart 25b and the sealingpart 23b, wherein theablation part 27 is arranged at the position where the radial dimension of the anchoringpart 25b and/or the sealingpart 23a is maximum, and theablation part 40 is arranged on the outer peripheral surface of theablation part 27 for at least one circle. The distal end ofanchor portion 25b is equipped with interiorsteel cable connector 22, and the near-end of sealing 23b is equipped with outersteel cable connector 24, and interiorsteel cable connector 22 can be dismantled with the distal end of interior steel cable and be connected, and outersteel cable connector 24 can be dismantled with outer steel cable pipe and be connected. The connectingpiece 72d comprises a nickel titanium pipe with laser cutting buckle patterns, and can swing in a staggered manner in multiple directions, such as front, back, left, right, up and down, so that the flexibility of the guiding function is improved. The connectingpiece 72d can deflect relative to the metal woven frame and the guide piece, so that the left atrialappendage occlusion device 100d can enter the left atrial appendage with an irregular shape more smoothly, and the implantation efficiency of the left atrialappendage occlusion device 100d is improved.

Theanchor portion 25b, theablation portion 27 and the sealingportion 23b have the same diameter, and the whole device has a cylindrical structure. Thesupport framework 20b in the embodiment is integrally formed by weaving metal wires into three parts of an integral structure of an anchoringpart 25b, anablation part 27 and a sealingpart 23b and then shaping, and an outersteel cable connector 24 arranged on the sealingpart 23b is tied at the near end; the distal end of theanchor portion 25b is beam welded to theconnection 72 d. The braided metal wire of the present embodiment may be nickel-titanium alloy, cobalt-chromium alloy, stainless steel, or other metal material with good biocompatibility. The super-elastic shape memory alloy nickel-titanium wire is preferably selected, and the manufacturing process is the same as that of the traditional left atrial appendage occluder, and the details are not repeated here. In addition to the above-mentioned integral structure, the anchoringportion 25b, theablation portion 27, and the sealingportion 23b may be directly fixed together by welding or the like.

The anchoringportion 25b comprises the distal frame itself, two layers of the flow-blockingmembrane 50, the anchoringthorn 252; the periphery of thechoke membrane 50 is fixed inside theanchor portion 25b by sewing, and thechoke membrane 50 is, for example, a PET or PTFE film. The anchoringthorns 252 are uniformly arranged on the outer wall of the cylindrical structure in a circle, and each anchoringthorn 252 extends towards the outer direction of the proximal end or is of a folded structure. The metal mesh skeleton of theanchor portion 25b is coated with an insulating coating (not shown) at least on the outer wall surface that is in contact with the left atrial appendage; the coating can be fixed on the metal framework of the anchoring part by coating, and an insulating sleeve, such as FEP or ETFE or PFA or PTFE sleeve, can be used to sleeve the insulating sleeve outside each metal wire.

Theablation part 40 is positioned in the area between theablation part 27 and the sealingpart 23b, and theablation part 40 is provided with at least one circle of metal annular framework along the circumferential direction of the metal grid framework. Preferably, the metal annular framework is connected with an ablation energy source, and the annular outer wall surface of the metal annular framework is a conductive ablation surface. The surface of the ablation surface is not insulated and is a bare metal structure.

In other embodiments, the supportingframe 20 is insulated except for theablation portion 27, and theablation part 40 is a portion of the metal cutting stent that is not insulated, i.e. at least one circle of electrically exposed region on the outer circumferential surface of theablation portion 27.

The sealingpart 23b is positioned at the proximal end of the metal woven frame and is matched with the neck part of the left auricle in shape; in this embodiment, the sealingportion 23b is fitted into the neck portion of the left atrial appendage, and the diameter of the sealingportion 23b matches the inner diameter of the neck portion of the left atrial appendage. The metal grid framework of the sealingpart 23b is coated with an insulating coating (not shown in the figure) at least on a sealing surface jointed with the left auricle, the insulating coating is one or more layers of insulating materials formed on the metal grid framework by adopting an insulating material coating mode, and the metal grid framework is isolated from being contacted with the left auricle for conducting electricity; the insulation of the sealingportion 23b may also be applied by means of an insulating sleeve over each wire of the metal grid skeleton. The sealing of the sealingportion 23b is performed by aflow blocking film 50 provided inside thereof, and the periphery of theflow blocking film 50 is fixed inside the sealing portion by sewing, for example, a PET or PTFE film.

Guide 70 is the hollow class rhombus structure of metal mesh check, the curved surface structure can prevent the left auricle wound, the class rhombus structure flexibility ratio is higher, implant the in-process of left auricle at leftauricle plugging device 100d,support skeleton 20b and connectingpiece 72d cooperation motion, can advance according to the automatic bending of the anatomical curvature of left heart passageway, go deep into the left auricle bottom, make leftauricle plugging device 100d keep better centering nature, prevent that leftauricle plugging device 100d from taking place the skew of great angle in the left auricle, make the shutoff firm and let melt the regional annular continuity on the left auricle inner wall.

Referring to fig. 12, a left atrialappendage occlusion device 100e according to a seventh embodiment of the present invention has a structure similar to that of the sixth embodiment, except that the structure of theguide member 70c and the structure of the connectingmember 72c in the seventh embodiment are different from those in the sixth embodiment, as follows: theguide member 70c and the connectingmember 72c of the seventh embodiment are of a wire integrally woven structure and can be connected to the distal end of the metal woven frame by welding, steel sleeve or integrally woven. The metal wire is an elastic shape memory alloy nickel titanium wire, so that theguide piece 70c and the connectingpiece 72c have good flexibility and the guiding function is enhanced.

In other embodiments, the guide member, the connector member, and the support frame are woven as a unitary structure from wires.

In other embodiments, the connecting member may also be a spring, a coil, or an elastic rubber rod, etc.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims (18)

1. The utility model provides a plugging device is ablated to left auricle, its including the support chassis and set up in the piece that melts of support chassis outer peripheral face, its characterized in that, the distal end of support chassis sets up the guide piece, the distal end of support chassis with be equipped with the connecting piece between the guide piece, the connecting piece can for the axial lead swing of support chassis, through the guide piece drives the connecting piece is crooked, until it laminates to melt the piece the suitable position of the inner wall of left auricle, melt the piece and melt the energy and be connected, it melts the inner wall of left auricle and annularly to melt the piece.

2. The left atrial appendage ablation occlusion device of claim 1, wherein the guide is a curved structure having an axial support force and a radial deformation force to conform to an inner wall of the left atrial appendage; or the guide is a curved structure with a distal end for preventing trauma to the inner wall of the left atrial appendage, and the guide is used for guiding the left atrial appendage occlusion device into the left atrial appendage.

3. The left atrial appendage ablation occlusion device of claim 2, wherein the guide is a hollow mesh cutting spherical stent, a nickel titanium wire mesh grid ellipsoid stent, an everted hemispherical metal cutting stent, an inverted drop-shaped metal stent or a diamond-like stent.

4. The ablation occlusion device of claim 1, wherein the distal end of the connector is welded, sewn or otherwise attached to the guide member; or the distal end of the connector and the guide are of a unitary metal construction.

5. The ablation occlusion device of claim 1, wherein the proximal end of the connector is welded, sewn or otherwise attached to the support frame; or the near end of the connecting piece and the supporting framework are of an integral metal structure.

6. The ablation occlusion device of claim 1, wherein the connector is in the form of a rotating shaft structure, a circular buckle structure, a universal joint structure, a snap structure, or a ball bearing structure.

7. The ablation occlusion device of claim 1, wherein the connector can be a spring, a hypotube, a helical tube, an elastic wire braided structure, or an elastic rubber rod.

8. The left atrial appendage ablation occlusion device of claim 1, wherein the connector is a wire woven wire structure integrally woven with the guide member with a wire and/or integrally woven with the support armature wire.

9. The ablation occlusion device of claim 1, wherein the support frame comprises an anchoring portion at a distal end and a sealing portion at a proximal end, wherein the anchoring portion and the sealing portion are formed of a metal braided or cut mesh, rod, or frame structure.

10. The left atrial appendage ablation occlusion device of claim 9, wherein the support framework further comprises an ablation portion disposed at a maximum radial dimension of the anchoring portion and/or the sealing portion, and the ablation member is disposed on an outer peripheral surface of the ablation portion for at least one turn.

11. The ablation occlusion device of claim 10, wherein the ablating member delivers an ablative energy source to the left atrial appendage for ablating the inner wall of the left atrial appendage in a ring-like pattern, the ablative energy source being one of a radio frequency, microwave, ultrasound, pulse, cryogen, or chemical ablative agent.

12. The ablation occlusion device of claim 1, wherein the outer surface of the supporting framework is circumferentially provided with at least one ring of anchoring thorns, each anchoring thorn extending in a proximal-to-distal direction or being of a folded structure.

13. The left atrial appendage ablation occlusion device of claim 1, wherein the outer surface of the support framework is circumferentially provided with at least one ring of visualization points or visualization filaments.

14. The left atrial appendage ablation occlusion device of claim 1, wherein the proximal end of the support frame is provided with an outer cable connector for detachably connecting to an outer cable tube.

15. The left atrial appendage ablation and occlusion device of claim 14, wherein an inner cable connector is disposed at the junction of the support framework and the connector, the inner cable connector is configured to detachably connect with an inner cable, the inner cable is inserted into the inner cavity of the outer cable tube, and the inner cable is axially movable and rotatable with respect to the outer cable tube.

16. The left atrial appendage ablation occlusion device of claim 15, wherein the inner cable connector is connected to the inner cable by a threaded structure; the outer steel cable pipe is connected with the outer steel cable connector through a threaded structure.

17. The left atrial appendage ablation occlusion device of claim 16, wherein the inner cable moves axially relative to the outer cable tube to move the inner cable connector and the outer cable connector relatively closer together or further apart to change a radial dimension of the support frame.

18. The left atrial appendage ablation occlusion device of claim 17, wherein the inner cable connector and the outer cable connector are relatively close together, the support frame decreasing in axial dimension and increasing in radial dimension; interior steel cable connector with outer steel cable connector keeps away from relatively, the axial dimension increase and the radial dimension of support chassis diminishes.

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