CN114246666A

CN114246666A - Ablation plugging device and ablation plugging system

Info

Publication number: CN114246666A
Application number: CN202011012310.7A
Authority: CN
Inventors: 王永胜; 刘成; 陈杰; 尤岩
Original assignee: Hangzhou Nori Medical Technology Co ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2020-09-23
Filing date: 2020-09-23
Publication date: 2022-03-29

Abstract

The invention provides an ablation plugging device and an ablation plugging system comprising the same, wherein the ablation plugging device comprises a plugging piece for plugging a left atrial appendage, and a conveyor for conveying the plugging piece to the left atrial appendage. The ablation plugging device provided by the invention can plug the left auricle through the plugging piece, and can also transmit ablation energy through the ablation piece on the plugging piece so as to ablate the inner wall of the left auricle.

Description

Ablation plugging device and ablation plugging system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an improved ablation plugging device and an improved ablation plugging system suitable for a left atrial appendage.

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 incidence of atrial fibrillation is also closely related to coronary heart disease, hypertension, heart failure and other diseases. The left atrial appendage not only is the most main part of atrial fibrillation thrombosis but also is one of key areas for generation and maintenance of the atrial fibrillation thrombosis due to the special form and structure of the left atrial appendage, and part of patients with atrial fibrillation can be electrically isolated actively).

One-stop treatment of radiofrequency ablation and left atrial appendage occlusion is one of the treatment hotspots of atrial fibrillation at present. Currently, a number of successful atrial fibrillation cases have been treated using a one-stop treatment approach that combines catheter radio frequency ablation and left atrial appendage occlusion. In the one-stop treatment method, through left atrial appendage occlusion, a patient can still obtain good stroke prevention effect under the condition of not needing to take anticoagulant drugs for life; and the symptoms of patients with atrial fibrillation are improved by combining with the radio frequency ablation of the catheter to recover and maintain the sinus rhythm, so that the patients can obtain stable long-term treatment effect. However, the currently used ablation methods are mainly: electrical isolation of the left atrial appendage (except for triggering foci not from the left atrial appendage which can lead to sustained atrial fibrillation, atrial flutter or atrial velocity) is not increased by pulmonary vein electrical isolation (PVI) plus ablation of "atrial fibrillation foci" outside the pulmonary veins. By adopting the ablation method, the recurrence rate of atrial fibrillation of a patient after 1 year is higher.

Research shows that for patients with long-range persistent atrial fibrillation, the left atrial appendage electrical isolation can reduce recurrence of postoperative atrial fibrillation without increasing operation complications.

However, the existing ablation catheters for treating atrial fibrillation are designed for pulmonary vein ablation, and due to the sizes and depths of the openings of the left atrial appendage and the large difference of the positions of the left atrial appendage of different patients, the existing pulmonary vein ablation catheters are obviously not suitable for the ablation of the left atrial appendage. Moreover, if the left auricle is to be ablated and blocked in the one-stop treatment process, an ablation catheter and a left auricle blocking device need to be introduced in an interventional mode, the key is to successively position two devices at the oral part of the left auricle and then respectively ablate and block the left auricle.

Disclosure of Invention

In order to solve the technical problems, the invention provides an ablation blocking device and an ablation blocking system comprising the ablation blocking device, wherein the ablation blocking device comprises a blocking piece for blocking a left atrial appendage, and a conveyor for conveying the blocking piece to the left atrial appendage, the ablation blocking device further comprises an ablation piece arranged on the blocking piece, a first conductive component is arranged on the ablation piece, the conveyor is correspondingly provided with a second conductive component electrically connected to an external ablation signal source, the first conductive component is electrically connected to the second conductive component in a detachable and detachable manner, and the ablation piece is used for transmitting ablation energy output by the external ablation signal source to ablate the left atrial appendage.

The invention also provides an ablation occlusion system comprising a mapping member and an ablation occlusion device as described above, a portion of the mapping member being adapted to be inserted into a hollow occlusion member, a distal end of the mapping member emerging from the distal end of the occlusion member for acquiring electrophysiological signals in left atrial appendage tissue.

The invention provides an ablation blocking device which comprises a blocking piece and an ablation piece arranged on the blocking piece. The occlusion piece is used for occluding the left atrial appendage, the ablation piece is electrically connected with the second conductive assembly of the conveyor in a detachable mode through the first conductive assembly, and the second conductive assembly is electrically connected with an external ablation signal source, so that the ablation piece can transmit ablation energy to ablate the left atrial appendage, and the effect of electrical isolation is achieved.

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.

Fig. 1 is a schematic structural diagram of an ablation occlusion device according to a first embodiment of the invention.

Fig. 2 is a schematic perspective view of the occluding member and the ablating member of the ablation occluding device of fig. 1.

Fig. 3 is a top view of the anchoring portion and ablating member of fig. 2.

Fig. 4 is a partial cross-sectional view of the multilumen tubing, the electrically conductive tube, the first electrically conductive wire, and the second electrically conductive wire taken along line IV-IV in the first embodiment.

Fig. 5 is a top view of an anchor portion and an ablating member provided in accordance with a second embodiment of the present invention.

Fig. 6 is a schematic structural view of a blocking member and an ablating member according to a third embodiment of the present invention.

Figure 7 is a top view of the occluding member and ablating member of figure 6.

Fig. 8 is a partial structural schematic view of an ablation occlusion device provided in accordance with a fourth embodiment of the invention.

Fig. 9 is a partial structural schematic view of an ablation occlusion device provided in a fifth embodiment of the invention.

Figure 10 is a schematic perspective view of the occluding member and ablating member of figure 9.

Fig. 11A is a schematic perspective view of a first connector and a second connector in the fifth embodiment.

Fig. 11B is a cross-sectional view of the first connector, the second connector, the first conductor, and the second conductor of fig. 9 taken along line XI-XI.

Fig. 12 is a partial structural view of the second connector, the inner sheath, and the outer sheath in the fifth embodiment.

Fig. 13 is a schematic partial structure view of an ablation occlusion system according to a sixth embodiment of the invention.

Fig. 14 is an axial cross-sectional view of the multilumen tubing, the electrically conductive tube, the first guidewire, the second guidewire, and the mapping member of fig. 13.

Fig. 15 is a partial structural schematic view of an ablation occlusion device according to a seventh embodiment of the invention.

Figure 16 is a partial cross-sectional view of the pull member and multi-lumen tube of figure 15 taken along line XVI-XVI.

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, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; the axial direction refers to the direction of a central axis of the medical instrument, and the radial direction refers to the direction perpendicular to the central axis of the medical instrument; the location where the left atrium enters the left atrial appendage is thus defined as the left atrial appendage opening, and the location within the left atrial appendage near the left atrial appendage opening is defined as the left atrial appendage neck. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 1 to 4 together, an ablation occlusion device 100 according to a first embodiment of the present invention includes an occlusion member 110 for occluding a left atrial appendage, and a delivery device 180 for delivering the occlusion member 110 to the left atrial appendage, the ablation occlusion device 100 further includes an ablation member 120 disposed on the occlusion member 110, the ablation member 120 is disposed with a first conductive element 140, the delivery device 180 is correspondingly disposed with a second conductive element 150 electrically connected to an external ablation signal source (not shown), the first conductive element 140 is electrically and detachably connected to the second conductive element 150, and the ablation member 120 is configured to transmit ablation energy outputted by the external ablation signal source to ablate the left atrial appendage.

The ablation occlusion device 100 provided by the application comprises an occlusion piece 110 for occluding the left atrial appendage and an ablation piece 120 arranged on the occlusion piece 110, wherein the ablation piece 120 is electrically connected with an external ablation signal source (not shown) through a first conductive component 140 and a second conductive component 150 in sequence, so that ablation energy is transmitted to left atrial appendage tissue, and the left atrial appendage tissue is electrically isolated. In addition, the first conductive assembly 140 can be electrically connected to the second conductive assembly 150 in a detachable manner, so that after the ablation is finished, the first conductive assembly 140 and the second conductive assembly 150 can be separated from each other without using an additional cutting device to cut off the electrical connection between the first conductive assembly 140 and the second conductive assembly 150, and the conveyor 180 drives the second conductive assembly to be withdrawn from the human body, so that the operation is simple and the use is convenient. The occluding member 110, ablating member 120, and first conductive element 140 remain at the left atrial appendage ostium.

Specifically, as shown in fig. 1, the delivery device 180 comprises an outer sheath 181 and a handle 185, wherein the proximal end of the outer sheath 181 is connected to the distal end of the handle 185, and the handle 185 is used for controlling the advancement, withdrawal and rotation of the outer sheath 181 in the blood vessel, the release process of the occluding member 110 and the ablation process of the ablating member 120.

The occluding member 110 is a self-expanding stent that may be a flexible metal stent or a non-metal (e.g., polymer) stent. In this embodiment, the occluding member 110 is a nitinol stent, and when the occluding member 110 is delivered by the delivery device 180, the diameter of the occluding member 110 is contracted to a smaller state for delivery in the sheath 181; when the plugging member 110 is delivered to the left atrial appendage opening and released, the plugging member 110 can automatically expand to a predetermined shape and size to be supported on the inner wall of the left atrial appendage opening, and the plugging member 110 can radially support the inner wall of the left atrial appendage so as to be fixed at the left atrial appendage opening. It should be noted that the blocking member 110 and the ablating member 120 of the ablation blocking device 100 in each drawing are in a freely expanded state, that is, the ablation blocking device 100 is not implanted at the left atrial appendage opening after being released from the distal end of the outer sheath tube 181. After the occluding member 110 is implanted at the opening of the left atrial appendage, the occluding member 110 is susceptible to deformation due to conforming to the different morphology of the left atrial appendage.

As shown in fig. 1 and fig. 2, the occlusion element 110 includes an occlusion part 111 and an anchoring part 115 connected to a distal end of the occlusion part 111, the occlusion part 111 is used to cover an opening of the left atrial appendage so as to block and isolate the left atrium and the left atrial appendage, and prevent thrombus in the left atrial appendage from entering the left atrium; the anchoring portion 115 is for fixation to the neck of the left atrial appendage to anchor the occluding member 110 at the opening of the left atrial appendage.

Further, the blocking portion 111 includes a blocking frame 112, one or more layers of flow-blocking membranes 113 disposed on the blocking frame 112, and a connecting end 114 disposed at a proximal end of the blocking frame 112.

In the present embodiment, the occluding frame 112 is formed by wire knitting, but in a modified embodiment, it may be formed by cutting a metal tube. The metal wire or the metal tube is made of nickel-titanium alloy, cobalt-chromium alloy, stainless steel or other metal materials with good biocompatibility, and preferably memory alloy materials such as nickel-titanium alloy and the like. In a modified embodiment, the plugging frame 112 is made of a non-metallic polymer material.

The plugging framework 112 is a double-layer mesh disk with a series of mesh holes, specifically, a frustum shape with a diameter gradually decreasing from a proximal end to a distal end, and the outline thereof may also be a disk shape, a cylinder shape, etc. The size and shape of the mesh in the plugging frame 112 can be set according to actual needs, and are not limited herein. In this embodiment, the contour of the plugging frame 112 is frustum-shaped, the maximum diameter of the plugging frame is larger than the diameter of the left atrial appendage opening, and the circumferential surface of the plugging frame 112 is a conical surface. When the plugging piece 110 is implanted into the left auricle, the distal end of the plugging framework 112 enters the left auricle, the maximum diameter of the plugging framework 112 is plugged at the side of the left auricle opening adjacent to the left atrium, and the myocardial tissue at the left auricle opening is attached to the conical surface of the plugging framework 112 around the circumference.

The occlusion part 111 occludes the left atrial appendage by at least one flow-blocking membrane 113 provided on the occlusion skeleton 112, and blocks thrombus, blood clots, and other substances in the left atrial appendage from flowing into the left atrium. The material of the obstructing membrane 113 may be PET, PTFE or other materials, and is fixed to the inner portion or the proximal end surface of the blocking frame 112 by sewing or adhesion. In this embodiment, two axially spaced flow-resisting membranes 113 are sewn inside the occluding frame 112. It is understood that when the mesh in the plugging frame 112 is small, the plugging frame itself may have a blocking function, and the plugging frame 112 may not be provided with the flow blocking film 113.

The plugging framework 112 comprises a plurality of supporting rods connected with each other, and the connecting end 114 is arranged at the proximal end of the plugging framework 112, and is used for collecting the proximal ends of the supporting rods together and detachably connecting with the conveyor 180. In this embodiment, the connecting end 114 is preferably a bolt head, the bolt head is provided with an internal threaded hole, the distal end of the outer sheath 181 is provided with an external thread matching with the internal threaded hole of the bolt head, and the connecting end 114 is screwed with the outer sheath 181 to realize the detachable connection of the block piece 110 with the outer sheath 181, so that the block piece 110 can be transported by moving the outer sheath 181, and the connection of the block piece 110 with the outer sheath 181 can be released after the block piece 110 is implanted into the left atrial appendage.

In other embodiments, the bolt head may be provided with an external thread, and the distal end of the outer sheath 181 is provided with an internal threaded hole matching with the external thread, so that the blocking member 110 can be detachably connected with the outer sheath 181 by means of a threaded connection.

In other embodiments, the connecting end 114 and the outer sheath 181 may be detachably connected to the blocking member 110 and the delivery device 180 by plugging, clipping, or the like, which is not described herein.

It should be noted that the distal end of the occluding frame 112 is not sealed. Specifically, in this embodiment, distal ends of a plurality of nitinol wires used for knitting to form the blocking frame 112 extend toward the distal end along the axial direction of the blocking piece 110, and enclose a region in the middle of the distal end of the blocking frame 112 to form a first channel 112H communicating with an inner cavity of the blocking frame 112, and the connecting end 114 is axially provided with a through hole correspondingly communicating with the first channel 112H.

Anchor portion 115 includes an anchor skeleton 116. The anchoring framework 116 may be a wire-interwoven stent having a series of meshes, a wire-supported grid or helical stent formed by parallel metal struts, or a wire-cut, wire-supported grid, wire-supported central-radial or helical stent. In the present embodiment, the anchoring frame 116 is a lattice-shaped stent formed by cutting a nitinol tube, and in a modified embodiment, the anchoring frame 116 is made of a non-metallic polymer material.

As shown in fig. 1 to 2, the anchoring framework 116 is a hemispherical structure, the middle portion of the anchoring framework includes a plurality of linear supporting rods, the linear supporting rods extend from the outer side to the proximal end after extending to the farthest end, so as to form a peripheral hemispherical structure, and surround the plurality of linear supporting rods therein, and the peripheral proximal end of the anchoring framework 116 is bent and extended to the inner side. The proximal end and the distal end of the outer part of the anchoring framework 116 are respectively connected to the opposite ends of the straight rods in the middle through a plurality of inclined rods, the anchoring framework 116 is approximately cylindrical, and the diameter of the anchoring framework is basically the same as the inner diameter of the neck of the left atrial appendage. When the occluding member 110 is implanted in the left atrial appendage, the outer surface of the anchoring framework 116 contacts the inner wall of the left atrial appendage to form a friction force, and the anchoring framework 116 can be directly used for anchoring the occluding member 110.

In this embodiment, the anchoring portion 115 further includes a plurality of anchoring thorns 117 continuously or intermittently arranged along the circumferential direction of the outer surface of the anchoring framework 116, and after the plugging member 110 is implanted into the left atrial appendage, the anchoring thorns 117 penetrate into the inner wall of the neck portion of the left atrial appendage to further anchor the plugging member 110, so as to effectively prevent the plugging member 110 from falling off. In this embodiment, the anchoring thorn 117 and the anchoring frame 116 are integrally formed, and the anchoring thorn 117 is disposed on a plurality of straight rods in the middle of the anchoring frame 116. The number of the anchoring thorns 117 is 5-15, the anchoring thorns 117 extend towards the outer side of the anchoring framework 116 and towards the proximal end, the included angle between the extending direction of the anchoring thorns 117 and the axial direction of the anchoring framework 116 is 30-60 degrees, and the extending length is 0.5-4 mm.

In other embodiments, the anchoring barbs 117 may be disposed at other reasonable locations on the anchoring framework 116, for example, on several beveled rods near the proximal end, so long as the anchoring barbs 117 are able to penetrate the inner wall of the left atrial appendage to enhance the stability of the occluding member 110 and not interfere with the ablation of the inner wall of the left atrial appendage by the ablating member 120 on the occluding member 110.

In other embodiments, the anchoring barbs 117 may be formed of the same or different material as the anchoring framework 116 and attached to the anchoring framework 116, for example, a nickel titanium wire or a nickel titanium rod may be sleeved or welded onto the anchoring framework 116 to form the anchoring barbs 117.

Optionally, the distal outer surface and/or interior of anchoring scaffold 116 is provided with at least one layer of a flow-blocking membrane. Preferably, in this embodiment, the outer distal surface of anchoring framework 116 is covered with a flow-blocking membrane (not shown) for blocking thrombus in the left atrial appendage from entering the left atrium. Moreover, the flow blocking film covering the outer surface of the distal end of the anchoring skeleton 116 may also be used to constrain the hemispherical structure of the distal end of the anchoring skeleton 116, so that it is not easily deformed to enhance the structural stability, and at the same time, the direct contact area between the anchoring skeleton 116 and the myocardial tissue is increased, and the stimulation effect of the material of the anchoring skeleton 116 on the myocardial tissue is reduced, thereby playing a certain protection role.

The anchoring frame 116 is fixedly connected to the blocking frame 112 so that the blocking portion 111 and the anchoring portion 115 are integrally connected. Specifically, in the present embodiment, the plugging frame 112 and the anchoring frame 116 are fixedly connected through a connecting tube 131. The connecting tube 131 may be an uncut part of the nitinol tube used to cut the anchoring framework 116, that is, the connecting tube 131 and the anchoring framework 116 are integrated, and the blocking framework 112 is welded to the proximal end of the connecting tube 131; alternatively, the connection tube 131 is a separate metal tube, and the blocking bobbin 112 and the anchoring bobbin 116 are welded to the proximal end and the distal end of the connection tube 131, respectively.

In other embodiments, the blocking frame 112 and the anchoring frame 116 may be directly fixedly connected by welding.

In other embodiments, when the plugging frame 112 and the anchoring frame 116 are both made by metal wire knitting and heat setting, the plugging frame 112 and the anchoring frame 116 may be integrally knitted, or may be respectively knitted and then fixedly connected together by welding or by means of a connecting pipe.

It should be noted that the anchoring framework 116 has a second channel 116H extending along the axial direction, and when the anchoring framework 116 is fixedly connected to the plugging framework 112, the second channel 116H of the anchoring framework 116, the first channel 112H of the plugging framework 112 and the through hole of the connecting end 114 are correspondingly communicated, so as to form a central channel 110H axially penetrating through the two opposite ends of the plugging member 110. When the block-out piece 110 is removably attached to the delivery device 180, the central channel 110H communicates with the lumen of the outer sheath 181.

Referring again to fig. 1-4, ablation elements 120 are disposed on the circumferential surface of anchoring portion 115 to be as close as possible to the inner wall tissue of the left atrial appendage, and ablation elements 120 enclose at least one ring shape in the circumferential direction of ablation occlusion device 100 to form an annular ablation zone for the inner wall of the left atrial appendage.

The ablation member 120 includes at least one ablation electrode therein. Where the external ablation energy source is a radio frequency signal source, the ablation electrode may transmit a single radio frequency signal to the inner wall tissue of the left atrial appendage, it being understood that the ablation member 120 may include multiple ablation electrodes for transmitting different radio frequency signals.

In this embodiment, the external ablation energy source is a pulse signal source, the ablation energy is high-voltage pulse energy, and the ablation member 120 is configured to transmit high-voltage pulse signals with different polarities to form a pulse electric field, and irreversible electroporation occurs in left atrial appendage tissue located in the pulse electric field. Accordingly, the ablating member 120 includes at least one pair of ablating electrodes 121, each pair including a positive electrode 121A and a negative electrode 121B. Each pair of ablation electrodes 121 is electrically connected to the positive electrode and the negative electrode of the pulse signal source through the first conductive member 140 and the second conductive member 150. When the plugging piece 110 is implanted and plugs the left atrial appendage, the at least one pair of ablation electrodes 121 is conducted with the pulse signal source to form a pulse electric field, and the at least one pair of ablation electrodes 121 can transmit a pulse energy string provided by the pulse signal source to ablate the inner wall of the left atrial appendage in the pulse electric field. Preferably, at least one pair of ablation electrodes 121 is symmetrically disposed about the axial centerline of the occluding member 110 to facilitate improved ablation uniformity.

It will be appreciated that in contrast to thermal ablation, pulsed ablation does not require thermal conduction to ablate deep tissue, and irreversible electroporation can occur as long as the tissue cells are within the pulsed electric field range above the electric field strength, and that even after the ablation member 120 is implanted in the left atrial appendage, the ablation electrode 121 does not fully conform to the inner wall of the left atrial appendage without affecting the ablation effect, and thus, the ablation member 120 can be circumferentially disposed along the outer and/or inner surface of the occluding member 110. That is, at least one pair of ablation electrodes 121 may be circumferentially disposed along the outer surface of the closure 110, or circumferentially disposed along the inner surface of the closure 110, or circumferentially disposed along both the outer and inner surfaces of the closure 110. Preferably, the at least one pair of ablation electrodes 121 are circumferentially disposed along the outer surface of the block piece 110, when the block piece 110 is implanted into the left atrial appendage, the at least one pair of ablation electrodes 121 is attached to the inner wall of the left atrial appendage, and a pulse electric field formed by the at least one pair of ablation electrodes 121 and the pulse signal source being conducted can cover more myocardial cells, which is beneficial to improving the utilization rate of pulse energy. In addition, at least one pair of ablation electrodes 121 may be disposed on the occlusion part 111, or on the anchoring part 115, or on both the occlusion part 111 and the anchoring part 115, depending on the location of the inner wall of the left atrial appendage to be ablated, i.e., the ablating member 120 may be selectively disposed on different portions of the occlusion part 110.

Wherein, the energy pulse train (i.e. pulse energy) provided by the pulse signal source comprises monophasic pulse or biphasic pulse, and at least one of pulse voltage, pulse width, repetition frequency, duty ratio or pulse number of the monophasic pulse or biphasic pulse can be adjusted, that is, the ablation part 120 electrically connected to the pulse signal source can transmit different energy pulse trains, so that the ablation part 120 can transmit corresponding energy pulse trains according to the difference of the physiological structures of the left atrial appendage of different patients, so as to effectively ablate the left atrial appendage of different patients.

Specifically, referring to fig. 2 and 3, in the present embodiment, the ablation element 120 includes a pair of ablation electrodes 121 disposed on the anchoring portion 115 in an axisymmetric manner, the pair of ablation electrodes 121 are conductive wires made of platinum, each ablation electrode 121 has an arc shape and occupies a central angle smaller than 180 degrees in the circumferential direction, that is, each ablation electrode 121 is a substantially semicircular electrode. The ablation electrodes 121 are distributed in the same horizontal plane in the axial direction of the blocking piece 110, and a positive electrode 121A and a negative electrode 121B in the ablation electrodes 121 are oppositely arranged and spaced at corresponding positions at the end part, so as to form an approximately complete electrode ring in a closed manner. When the pair of ablation electrodes 121 is connected to the pulse signal source and powered on, an annular pulse electric field is formed between the positive electrode 121A and the negative electrode 121B, and the inner wall of the left atrial appendage within the range of the annular pulse electric field above a certain electric field intensity can be ablated annularly under the action of the pulse electric field.

The conductive wires are circumferentially wound and fixed on a plurality of support rods of the anchoring framework 116, and the ablation electrodes 121 are arranged along the extending direction of the support rods and form a plurality of saw teeth.

In other embodiments, the ablation electrode 121 may be a conductive wire made of any other conductive material, such as platinum-iridium alloy, gold, nickel-titanium alloy, or stainless steel.

In other embodiments, the ablation electrode 121 may also be a substantially semicircular conductive sheet or conductive tube made of any one of the above conductive materials, and fixed on the blocking member 110 by corresponding methods such as adhesion, suture, sheathing, or covering with a heat-shrinkable film.

Preferably, the ablation electrodes 121 and the blocking piece 110 are insulated, so that the ablation electrodes 121 for transmitting electrical pulse signals with different polarities are prevented from being mutually short-circuited through the blocking piece 110, that is, the positive electrodes 121A and the negative electrodes 121B cannot be mutually communicated and short-circuited through the conductive anchoring frameworks 116, and the safety and reliability of the system are ensured.

Specifically, in the present embodiment, the outer surface of the anchoring backbone 116 in contact with the ablation electrode 121 is coated with an insulating coating. In other embodiments, the outer surface of the anchoring framework 116 contacting the ablation electrode 121 may be coated with an insulating medical adhesive, coated with an insulating film, or sleeved with an insulating sleeve, which may also achieve insulation between the ablation electrode 121 and the occlusion member 110. The material of the insulating coating, the insulating coating and the insulating sleeve is selected from FEP, ETFE, PTFE, PFA and the like. In one embodiment, the anchoring framework 116 is also insulated from at least a portion of the surface of the occluding framework 112 not in contact with the ablation electrode 121.

Referring to fig. 2 to 4, as mentioned above, each ablation electrode 121 is electrically connected to the pulse signal source through the first conductive element 140 and the second conductive element 150. The first conductive element 140 includes at least one first conductive line 141, each ablation electrode 121 is connected to a corresponding first conductive line 141, the second conductive element 150 includes at least one second conductive line 151, each first conductive line 141 is connected to a corresponding second conductive line 151, and each second conductive line 151 is connected to a positive or negative signal output terminal of the pulse signal source.

In this embodiment, the positive electrode 121A and the negative electrode 121B transmit high-voltage pulse signals with different polarities, and accordingly, the first conductive assembly 140 includes two first conductive wires 141 insulated from each other, and the second conductive assembly 150 includes two second conductive wires 151 insulated from each other. The first conducting wire 141 for connecting the positive electrode 121A is a first positive conducting wire 141A, the second conducting wire 151 for connecting the positive electrode of the external pulse signal source is a second positive conducting wire 151A, the first conducting wire 141 for connecting the negative electrode 121B is a first negative conducting wire 141B, and the second conducting wire 151 for connecting the negative electrode of the external pulse signal source is a second negative conducting wire 151B. The number of first conductive wires 141 in the first conductive element 140 and the number of second conductive wires 151 in the second conductive element 150 are directly related to the overall type of electrical signal transmitted by the ablating member 120.

In an alternate embodiment, where the ablating member 120 is configured to transmit a radio frequency ablation signal, and where the ablating member 120 includes an ablation electrode 121, and is configured to transmit a single radio frequency ablation signal to the left atrial appendage tissue, the first conductive element 140 includes a first conductive wire 141, one end of the first conductive wire 141 is coupled to the ablation electrode 121, and the second conductive element 150 includes a second conductive wire 151, and the second conductive wire 151 is electrically coupled to an output of an external radio frequency ablation source. Preferably, the one ablation electrode 121 surrounds the occlusion member 110 in a circumferential direction by at least one turn.

In this embodiment, an end of each first wire 141 away from the ablation electrode 121 is detachably and electrically connected to a distal end of the corresponding second wire 151, and a proximal end of the second wire 151 is electrically connected to the positive electrode or the negative electrode of the pulse signal source. Specifically, one end of each first positive wire 141A away from the ablation electrode 121 is detachably and electrically connected to the distal end of the corresponding second positive wire 151A, and the proximal end of the second positive wire 151A is electrically connected to the positive electrode of the pulse signal source; one end of each first negative wire 141B, which is far away from the ablation electrode 121, is detachably and electrically connected to the distal end of the corresponding second negative wire 151B, and the proximal end of the second negative wire 151B is electrically connected to the negative electrode of the pulse signal source, so that each ablation electrode 121 is electrically connected to the positive electrode or the negative electrode of the pulse signal source, respectively, and thus each ablation electrode 121 can receive the pulse energy provided by the pulse signal source.

The first wire 141 is an extension of the ablation electrode 121 itself, and in this embodiment, one end of the conductive wire for forming the ablation electrode 121 is not wound around and fixed on the anchoring framework 116, that is, the first wire 141 is an extension of the corresponding ablation electrode 121 itself.

In other embodiments, the first wire 141 may be a separate conductive wire, and the first wire 141 is electrically connected to the corresponding ablation electrode 121 by welding or steel sleeve fixation.

As shown in FIGS. 1 and 4, in this embodiment, a multilumen tubing 183 is movably disposed within the outer sheath 181 of the delivery device 180, the multilumen tubing 183 being extendable from the distal end of the outer sheath 181 and into the central passage 110H of the blocking member 110 which is detachably connected to the outer sheath 181. The multi-lumen tube 183 is made of an insulating medical interventional material such as TPU or PVC, and a plurality of accommodating lumens 184 extending in the axial direction and penetrating the proximal end and the distal end of the multi-lumen tube 183 are provided at intervals inside the multi-lumen tube 183. The number of the accommodating cavities 184 is equal to the number of the second conductive wires 151, and each accommodating cavity 184 accommodates the mutually connected end portions of the corresponding first conductive wire 141 and the corresponding second conductive wire 151, thereby being beneficial to improving the reliability of the transmission of the pulse signals with different polarities. After the multi-lumen tube 183 has been advanced into the central passage 110H of the closure 110, the proximal end of each first wire 141 extends from the distal end of the multi-lumen tube 183 into one of the receiving lumens 184 and is releasably electrically connected to the distal end of the second wire 151 in that receiving lumen 184. In the present embodiment, the multi-lumen tube 183 is formed with a positive accommodation chamber 184A and a negative accommodation chamber 184B spaced apart from each other, the positive accommodation chamber 184A accommodating an end portion where the first positive wire 141A and the second positive wire 151A are connected to each other, and the negative accommodation chamber 184B accommodating an end portion where the first negative wire 141B and the second negative wire 151B are connected to each other. In a modified embodiment, the multi-lumen tube 183 is disposed proximal to the closure 110 and does not enter the central passage 110H.

In one embodiment, the ends of the first and second

conductive wires

141 and 151 overlap each other in the receiving cavity 184, for example, the ends of the first and second positive conductive wires 141A and 151A contact each other in the receiving cavity 184A to be electrically conducted. Specifically, the distal ends of the second wires 151 are fixedly disposed in the accommodating cavity 184 of the multi-lumen tube 183, and one end of each first wire 141, which is far away from the ablation electrode 121, extends into the accommodating cavity 184 and then is electrically connected to the distal end of the corresponding second wire 151 through any one of parallel contact, winding contact, insertion contact, cross contact, or the like, and the contact portions of the two are accommodated in the distal end of the accommodating cavity 184. The delivery of the pulse energy between the first wires 141 and the corresponding second wires 151 can be achieved by direct contact connection, and when the second wires 151 are withdrawn proximally after the ablation is completed, the second wires 151 drive the multi-lumen tube 183 to withdraw, so that the proximal ends of the first wires 141 are separated from the distal ends of the corresponding second wires 151.

The first conductive wire 141 and the second conductive wire 151 are electrically connected to each other through a conductive connecting member, which is a conductive tube 153 in this embodiment. Specifically, the second conductive assembly 150 includes at least one conductive tube 153 made of a conductive material, each conductive tube 153 is accommodated in the corresponding accommodating cavity 184, a distal end of each conductive tube 153 is movably connected to a proximal end of the corresponding first conductive wire 141, and a proximal end of each conductive tube 153 is fixedly connected to a distal end of the corresponding second conductive wire 151; during the process that each second conductive wire 151 drives the corresponding conductive tube 153 to move towards the proximal end relative to the blocking member 110, the corresponding conductive tube 153 is separated from the distal end of the first conductive wire 141 accommodated therein.

One end of each first conducting wire 141, which is far away from the ablation electrode 121, extends into one of the accommodating cavities 184, and then is movably inserted into the distal end of the conductive tube 153 in the accommodating cavity 184, the distal end of the corresponding second conducting wire 151 is inserted into the proximal end of the conductive tube 153, and the first conducting wires 141 and the corresponding second conducting wires 151 are electrically connected through the conductive tube 153, so as to realize the transmission of pulse energy.

In this embodiment, the proximal end of the first wire 141 is movably connected to the distal end of the conductive tube 153, and the multi-lumen tube 183 is fixedly disposed on the outer surface of the at least one conductive tube 153 and moves synchronously with the at least one conductive tube 153. After the ablation of the inner wall of the left atrial appendage is completed, the at least one second wire 151 is controlled by the handle 185 to move proximally relative to the occluding member 110, the distal end of the second wire 151 drives the conductive tube 153 and the multi-lumen tube 183 to move proximally synchronously, the first wire 141 is separated from the distal end of the conductive tube 153, the handle 185 drives the outer sheath tube 181, the multi-lumen tube 183, and the second conductive assembly 150 (the second wire 151 and the conductive tube 153) to withdraw from the body, and the occluding member 110, the ablating member 120, and the first conductive assembly 140 remain at the left atrial appendage.

It will be appreciated that the distal end of the second wire 151 and the proximal end of the conductive tube 153 may be movably connected, such as by plugging, snapping, etc., as is commonly done in the art.

In a modified embodiment, the ablation occlusion device 100 omits the multi-lumen tube 183, and the conductive tubes 153 are insulated from each other by other means, for example, the outer wall of the conductive tube 153 is insulated, and the outer wall of the conductive tube 153 is detachably connected to the occlusion member 110.

In a modified embodiment, the second conductive assembly comprises a plurality of pairs of conductive tubes 153, that is, at least two conductive tubes 153 for connecting to the positive pole of the external pulse signal source and at least 2 conductive tubes 153 for connecting to the negative pole of the external pulse signal source, and the plurality of conductive tubes 153 for connecting to the positive pole of the external pulse signal source are used for transmitting different electrical signals, and the plurality of conductive tubes 153 for connecting to the negative pole of the external pulse signal source are used for transmitting different electrical signals.

Each conductive tube 153 is movably disposed through the sheath tube 181, and the distal end of each conductive tube 153 can extend out from the distal end of the sheath tube 181 and enter the central channel 110H of the blocking member 110 detachably connected to the sheath tube 181, and the conductive tubes 153 are insulated from each other and respectively connected to the positive electrode or the negative electrode of the corresponding pulse signal source. At least one first positive wire 141A connected with the positive electrode of the pulse signal source is inserted into the conductive tube 153 connected with the positive electrode of the pulse signal source, and at least one first negative wire 141B connected with the negative electrode of the pulse signal source is inserted into the conductive tube 153 connected with the negative electrode of the pulse signal source, so that each ablation electrode 121 is connected with the positive electrode or the negative electrode of the pulse signal source through the corresponding first wire 141 and the corresponding conductive tube 153, and therefore pulse energy is transmitted to ablate the inner wall of the left atrial appendage. The first conducting wire 141 is connected with the corresponding conducting tube 153 in a non-fixed mode in an inserting mode, and when the conducting tube 153 is moved axially towards the near end after ablation is completed, the first conducting wire 141 can be separated from the corresponding conducting tube 153, so that the electrical connection between the first conducting wire 141 and the corresponding conducting tube 153 is released, and the operation is simple and convenient.

In other embodiments, when the ablating member 120 includes a plurality of pairs of ablation electrodes 121, the number of first wires 141 is correspondingly a plurality of pairs, and the number of conductive tubes 153 can be a plurality of pairs or a pair. Specifically, when the number of the conductive tubes 153 is multiple, each first positive wire 141A connected to the positive electrode of the pulse signal source is connected to the positive electrode of the pulse signal source through a corresponding conductive tube 153, and each first negative wire 141B connected to the negative electrode of the pulse signal source is connected to the negative electrode of the pulse signal source through a corresponding conductive tube 153, so that each ablation electrode 121 is correspondingly connected to the positive electrode or the negative electrode of the pulse signal source; when the number of the conductive tubes 153 is one pair, all the first conducting wires 141 connected to the positive electrode of the pulse signal source are connected to the positive electrode of the pulse signal source through one of the conductive tubes 153, and all the first negative conducting wires 141B connected to the negative electrode of the pulse signal source are connected to the negative electrode of the pulse signal source through the other conductive tube 153, so that each ablation electrode 121 can be correspondingly connected to the positive electrode or the negative electrode of the pulse signal source. It can be understood that the ablation member 120 includes a plurality of pairs of ablation electrodes 121, and the number of the conductive tubes 153 and the number of the first conductive wires 141 are both a plurality of pairs, each ablation electrode 121 can be independently connected to the pulse signal source through the corresponding first conductive wire 141 and the corresponding conductive tube 153, so that selective ablation of the inner wall of the left atrial appendage can be realized, and the practicability of the ablation occlusion device 100 is enhanced.

Preferably, in this embodiment, one end of the first conducting wire 141 is electrically connected to the corresponding ablation electrode 121, and the other end of the first conducting wire extends into one of the accommodating cavities 184 to be detachably and electrically connected to the corresponding second conducting wire 151, and the outer surface of the portion of the first conducting wire 141 exposed from the accommodating cavity 184 (i.e. the portion between the two ends of the first conducting wire 141) is insulated to avoid the first conducting wire 141 interfering with the pulsed electric field formed by the ablation electrode 121 or causing a short circuit after being powered on. Accordingly, one end of the second conductive wire 151 is electrically connected to the positive or negative output end of the pulse signal source, and the other end extends into an accommodating cavity 184 to be electrically connected to the corresponding first conductive wire 141, and the outer surface of the portion of the second conductive wire 151 exposed out of the accommodating cavity 184 (i.e., the portion between the two ends of the second conductive wire 151) is subjected to insulation treatment. The insulation treatment may be any one of the insulation treatment methods between the blocking piece 110 and the ablation electrode 121, and is not described herein again.

As shown in fig. 2 to 3, the blocking member 110 includes a supporting frame, and the supporting frame includes a blocking frame 112 and an anchoring frame 116, i.e., the ablation electrode 121 is a conductive wire wound on the supporting frame. In this embodiment, at least one wire slot 118 is formed on the surface of the supporting framework, and each wire slot 118 extends along the direction of the corresponding first wire 141 and is used for accommodating the corresponding first wire 141. In this embodiment, the wire groove 118 is disposed on the upper surface of the anchoring framework 116 of the anchoring portion 115, the wire groove 118 is disposed along the extending direction of each support rod on the anchoring framework 116, and the partial section of the first wire 141 exposed out of the accommodating cavity 184 is embedded in the wire groove 118, so as to prevent the first wires 141 from being intertwined with each other, and meanwhile, the wire groove can play a role of stabilizing the first wires 141. In other embodiments, the wire slot 118 is omitted from the support frame.

It should be noted that the conveyor 180 further includes a conveying sheath (not shown) sleeved outside the outer sheath 181; the operator controls the relative movement of the outer sheath 181, the multi-lumen tube 183, and the delivery sheath via the handle 185. Also provided herein is an ablation occlusion system that includes an ablation occlusion device 100, and a guiding device (such as a guiding guidewire).

The structure of the conveying sheath and the handle 185 is similar to that of a conveying sheath and a handle commonly used in the prior art, and the details are not repeated here.

Hereinafter, the use of the ablation occlusion device 100 provided in the present embodiment will be described:

the first step is as follows: the connecting end 114 of the occluding portion 111 is connected to the distal end of the outer sheath 181 by means of a screw connection, so that the occluding member 110 is detachably connected to the outer sheath 181, and the first lead 141 connected to each ablation electrode 121 is detachably electrically connected to the corresponding second lead 151 in the multi-lumen tube 183.

The second step is that: the transvenous-right atrium-interatrial-left atrium-left atrial appendage approach is selected, an access channel is established from outside the patient's body to inside the patient's body using the delivery sheath of transporter 180 and the guide device, and the guide device is withdrawn, leaving the delivery sheath.

The third step: the diameter of the blocking member 110 is contracted, the blocking member 110 and the outer sheath 181 are inserted into the delivery sheath, and then the outer sheath 181 is pushed distally along the axial direction of the delivery sheath, so that the outer sheath 181 pushes the blocking member 110 to extend from the distal end of the delivery sheath and release the blocking member in the left atrial appendage. In the process, the plugging piece 110 is positioned by radiography and ultrasonic means to ensure that after the plugging piece 110 is implanted into the left atrial appendage, the anchoring part 115 is released at the neck part of the left atrial appendage, the anchoring thorn 117 of the anchoring part 115 penetrates into the inner wall of the left atrial appendage, the plugging part 111 is positioned at the opening of the left atrial appendage, the plugging framework 112 part of the plugging part 111 is plugged into the left atrial appendage, and the plugging piece 110 plugs the left atrial appendage through the flow blocking membrane 113.

The fourth step: the proximal end of each second wire 151 is correspondingly connected with the positive electrode or the negative electrode of the pulse signal source, the parameters of pulse ablation are adjusted, and pulse energy is transmitted to each ablation electrode 121 through the second wires 151 and the correspondingly connected first wires 141, so that the pulse ablation of the inner wall of the left atrial appendage is realized.

The fifth step: after the ablation is completed, the multi-lumen tube 183 is withdrawn proximally along the axial direction of the outer sheath tube 181, so that the second wires 151 in the multi-lumen tube 183 are separated from the corresponding first wires 141, then the outer sheath tube 181 is rotated to release the threaded connection between the outer sheath tube 181 and the connecting end 114 of the blocking piece 110, the outer sheath tube 181, the multi-lumen tube 183 and the second conductive assembly 150 are withdrawn from the patient through the delivery sheath tube, and finally the delivery sheath tube is withdrawn, so that the operation is completed.

The ablation occlusion device 100 provided in this embodiment is delivered to the left atrial appendage through the delivery device 180, the occlusion piece 110 is used for occluding the left atrial appendage, the ablation piece 120 on the occlusion piece 110 is electrically connected to the second lead 151 through the first lead 141 in a detachable manner, and the second lead 151 is electrically connected to an external ablation signal source, so that the ablation piece 120 transmits ablation energy to ablate the left atrial appendage, thereby achieving the effect of electrical isolation. After the ablation is completed, in the process of withdrawing the transporter 180, the transporter 180 can drive the second conducting wire 151 to be separated from the first conducting wire 141, so that the second conducting wire 151 and the transporter 180 are withdrawn together, an additional cutting device is not needed to cut off the electric connection between the first conducting wire 141 and the second conducting wire 151, and the operation is simple and the use is convenient.

Referring to fig. 5, an ablation occlusion device according to a second embodiment of the present invention is substantially similar to the ablation occlusion device 100 of the first embodiment, except that: in the second embodiment, the annular ablation member 220 includes two pairs of ablation electrodes 221 distributed on the anchoring portion 115, and the two pairs of ablation electrodes 221 are spaced apart from each other to form an annular shape. Two positive electrodes 221A and two negative electrodes 221B are arranged in a staggered manner in the circumferential direction of the plugging member 110, that is, one positive electrode 221A is disposed between two negative electrodes 221B adjacent thereto, and one negative electrode 221B is disposed between two positive electrodes 221A adjacent thereto.

Specifically, in the present embodiment, the ablation part 220 includes two pairs of ablation electrodes 221 arranged at intervals along the circumferential direction of the anchoring portion 115, each ablation electrode 221 is substantially arc-shaped, a central angle occupied in the circumferential direction is smaller than 90 degrees, and two circumferentially adjacent ablation electrodes 221 are respectively connected to the positive electrode and the negative electrode of the pulse signal source and are kept at intervals to realize insulation. The ablation electrodes 221 are located in the same horizontal plane in the axial direction. After the two pairs of ablation electrodes 221 are connected with a pulse signal source and powered on, an annular pulse electric field can be formed, so that annular ablation is performed on the inner wall of the left atrial appendage within the range of the pulse electric field.

In other embodiments, the ablating member 220 may include more than two pairs of ablation electrodes 221 spaced circumferentially along the anchoring portion 115.

It can be understood that, the more the ablation electrodes 221 are spaced along the circumference of the anchoring portion 115, the smaller the area of each ablation electrode 221 in the circumference of the anchoring portion 115 is, and the more uniform the field intensity distribution of the pulsed electric field in the area is. Therefore, the field intensity distribution of the pulse electric field formed by the pairs of ablation electrodes 221 in the second embodiment by connecting the anode and the cathode of the pulse signal source in a staggered manner is more uniform, which is beneficial to improving the ablation uniformity. Furthermore, in the second embodiment, each ablation electrode 221 can be independently connected to a pulse signal source, so that after at least one pair of ablation electrodes 221 in the plurality of pairs of ablation electrodes 221 are respectively connected to the positive electrode and the negative electrode of the pulse signal source, the at least one pair of ablation electrodes 221 can perform partial ablation on the inner wall of the left atrial appendage. That is, in the second embodiment, one or more pairs of ablation electrodes 221 are respectively connected to the positive electrode and the negative electrode of the pulse signal source, so that selective ablation of the inner wall of the left atrial appendage can be realized, and the practicability of the ablation occlusion device 200 can be enhanced.

It should be noted that, in the second embodiment, any pair of ablation electrodes 221 in the pairs of ablation electrodes 221 may be two ablation electrodes 221 symmetrically disposed about the axis of the anchoring portion 115, or two ablation electrodes 221 adjacent or non-adjacent along the circumferential direction of the anchoring portion 115, which is specifically set according to actual needs, and is not limited herein. In other embodiments, at least a portion of the ablation electrode 221 is disposed on a surface of the occlusion.

Referring to fig. 6 and 7, an ablation occlusion device 300 according to a third embodiment of the invention is different from the ablation occlusion device 100 according to the first embodiment in that: the ablation elements 320 enclose a plurality of rings in the circumferential direction of the ablation occlusion device 300, and the rings are spaced in the axial direction of the ablation occlusion device 300. Specifically, the ablating member 320 includes a pair of ablation electrodes 321 distributed in different horizontal planes in the axial direction of the occluding member 310. One of the ablation electrodes 321 is disposed on the plugging portion 311, the other ablation electrode 321 is disposed on the anchoring portion 315, each ablation electrode 321 is a closed-loop annular electrode, and two axially adjacent ablation electrodes 321 are respectively connected to the positive electrode and the negative electrode of the pulse signal source. After the pair of ablation electrodes 321 is connected with a pulse signal source and powered on, a ring-shaped pulse electric field can also be formed, so that ring-shaped ablation is performed on the inner wall of the left atrial appendage within the range of the pulse electric field.

In other embodiments, the pair of ablation electrodes 321 may both be disposed on the anchoring portion 315, or both be disposed on the occluding portion 311.

In other embodiments, the ablating member 320 may further include pairs of ablation electrodes 321 coaxially disposed in different horizontal planes in the axial direction of the occluding member 310; or the ablation member 320 is provided with at least one pair of ablation electrodes 321 in each formed ring, adjacent ablation electrodes 321 in the same ring are used for transmitting pulse signals with opposite polarities, in the embodiment of multiple rings surrounded by the ablation member 320, the multiple rings are spaced apart in the axial direction, and two adjacent ablation electrodes 321 in different rings can transmit pulse signals with the same or opposite polarities.

In the third embodiment, a pair of ablation electrodes 321 are coaxially distributed in different horizontal planes in the axial direction of the occlusion piece 310, and the coverage of the annular pulsed electric field formed by the pair of ablation electrodes 321 in the axial direction of the occlusion piece 310 is increased, so that the ablation area of the inner wall of the left atrial appendage can be increased; moreover, the annular pulse electric field is formed by two annular electrode rings at axial intervals, the field intensity distribution is more uniform and concentrated, and the ablation on the inner wall of the left auricle is more uniform. In addition, when the ablation electrode 321 is arranged on the blocking part 311, the pulse ablation can be performed on the position close to the opening part of the left atrial appendage, which is beneficial to improving the ablation success rate.

As shown in fig. 6, the third embodiment provides an ablation occlusion device 300 that is also different from the ablation occlusion device 100 of the first embodiment in that: the blocking portion 311 and the anchoring portion 315 of the block piece 310 are of unitary construction, i.e. the block piece 310 is of unitary construction. The blocking member 310 in this embodiment is formed by integrally cutting a nickel-titanium metal tube, and in a modified embodiment, may be formed by integrally knitting a nickel-titanium metal wire. Wherein the proximal end of the occluding member 310 is provided with a connecting end 114 for detachably connecting a delivery device and the distal end is provided with a connecting member 319 for gathering the distal end of the occluding member 310. The outer surface of the anchoring portion 315 is circumferentially provided with a plurality of anchoring barbs 317 for anchoring the plugging member 310, and each anchoring barb 317 is correspondingly arranged at a connection position of a plurality of inclined rods and a middle straight rod of the anchoring portion 315 close to the far end. In addition, the distal outer surface of the anchor 315 is covered with a flow-blocking membrane (not shown). It is understood that the blocking member 310 has the same function as the blocking member 110 of the first embodiment, and thus, the description thereof is omitted.

In this embodiment, a wire groove is omitted from the anchor portion 315, and the first wire 341 freely passes through the space in the middle of the block piece 310 to connect to a second wire (not shown).

Referring to fig. 8, an ablation occlusion device 400 according to a fourth embodiment of the present invention is substantially similar to the ablation occlusion device 100 of the first embodiment, except that: the multi-lumen tube 483 is fixedly arranged to the blocking member 110, and during proximal movement of the at least one electrically conductive tube 453, the multi-lumen tube 483 is detached from the at least one electrically conductive tube 453 and the multi-lumen tube 483 remains in the blocking member 110. Specifically, the multi-lumen tube 483 is fixedly disposed within the central passage 110H of the blocking piece 110 by welding or snap-fitting, and has a structure substantially the same as that of the multi-lumen tube 183, which is not described herein again.

In one embodiment, the second conductive wires are tubular conductive tubes 453, the conductive tubes 453 include cavities penetrating through both ends thereof, a distal end of each conductive tube 453 is movably connected to a proximal end of a corresponding first conductive wire, for example, in the first embodiment, an end of the first conductive wire, which is far away from the ablation electrode, is inserted into one end of the cavity of the conductive tube 453, and the proximal end of each conductive tube 453 is electrically connected to an output end of an external ablation signal source.

Referring to fig. 9 to 12, an ablation occlusion device 500 according to a fifth embodiment of the present invention is substantially similar to the ablation occlusion device 100 of the first embodiment, except that: in the fifth embodiment, the conductive connection between the first wire 541 and the second wire 551 is the first connector 542 and the second connector 552. Specifically, the first conductive element 540 includes a first connector 542 connected to an end of the at least one first conductive wire 541 remote from the ablating member 520, the second conductive element 550 includes a second connector 552 connected to an end of the at least one second conductive wire 551 remote from the external ablation signal source, the first connector 542 is removably connected to the second connector 552, and a plurality of conductive traces are disposed within the first connector 542 and the second connector 552 to conduct corresponding electrical signals between the first conductive wire 541 and the second conductive wire 551.

Each first wire 541 is correspondingly connected with the positive pole or the negative pole of the pulse signal source through the first connector 542 and the second connector 552, so that each ablation electrode 121 is connected with the positive pole or the negative pole of the pulse signal source through the corresponding first wire 541, the corresponding first connector 542, the corresponding second connector 552 and the corresponding second wire 551, and therefore pulse energy is transmitted to ablate the inner wall of the left atrial appendage.

In this embodiment, the structures of the first connector 542 and the second connector 552 are similar to those of the plug connector in the prior art, and are not described herein again. Specifically, the delivery device 180 further includes an inner sheath 560 movably disposed inside the outer sheath 181, and the second wire 552 is disposed inside the inner lumen of the inner sheath 560 and is electrically connected to the positive electrode or the negative electrode of the pulse signal source. A second connector 552 is fixedly disposed at the distal end of the inner sheath 560, and the proximal end of the second connector 552 is electrically connected to at least one second wire 551; the first connector 542 is detachably connected to the second connector 552, and the first connector 542 is electrically connected to the first wires 541, and a plurality of connecting wires (not shown) are disposed in the second connector 552 and the first connector 542 to connect the corresponding first wires 541 and the corresponding positive or negative electrode of the pulse signal source, so as to provide pulse energy to the ablation electrode 121.

In this embodiment, the inner sheath 560 is fixedly connected to the second connector 552, the first connector 542 is fixedly connected to the plurality of first wires 541, and the second connector 552 is detachably connected to the first connector 542, so that when the inner sheath 560 moves axially and proximally in the outer sheath 181, the inner sheath 560 can drive the second wires 551 and the second connector 552 to disengage from the first connector 542, thereby disconnecting the electrical connection between the first wires 541 and the positive pole or the negative pole of the corresponding pulse signal source.

In other embodiments, the plurality of first wires 541 are detachably inserted into the first connector 542, the second connector 552 is fixedly connected to the first connector 542, and when the inner sheath 560 axially moves proximally in the outer sheath 181, the inner sheath 560 can drive the first connector 542 and the second connector 552 to move proximally, so that the first connector 542 is separated from the plurality of first wires 541, and the electrical connection between the first wires 541 and the corresponding positive or negative electrode of the pulse signal source can also be released. In a modified embodiment, the inner sheath 560 is omitted, and the first connector 542 and the second connector 552 are pulled to be disengaged from each other while the second lead 551 is moved proximally.

The fifth embodiment provides an ablation occlusion device 500 which is different from the ablation occlusion device 100 of the first embodiment in that: the structure of the block piece 510 is different from that of the block piece 110 in the first embodiment. Specifically, in this embodiment, the plugging frame 512 of the plugging portion 511 is a disk-shaped structure formed by weaving metal wires, the anchoring portion 515 is a central radial bracket made of a cut metal tube, and the plugging frame 512 and the anchoring frame 516 are connected into a whole through a connecting tube 531. The diameter of the occlusion skeleton 512 is larger than that of the left atrial appendage opening, and when the occlusion piece 510 is implanted and released in the left atrial appendage, the distal end face of the occlusion skeleton 512 is attached to the left atrial appendage opening and faces the left atrium. The outer surface of the anchoring framework 516 is circumferentially provided with a pair of ablation electrodes 521, and the pair of ablation electrodes 521 are coaxially arranged in different horizontal planes in the axial direction of the plugging piece 510 for ablation of the inner wall of the left atrial appendage. The outer surface of the distal end of the anchoring framework 516 is covered with a flow-blocking film (not shown) for blocking thrombus in the left atrial appendage from entering the left atrium, and meanwhile, the structural stability of the anchoring framework 516 can be enhanced, the direct contact area between metal and myocardial tissue can be reduced, and a certain protection effect can be achieved. The remaining structure of the block piece 510 is substantially the same as that of the block piece 110 in the first embodiment, and will not be described here again.

Referring to fig. 13 and 14, an ablation occlusion device 600 according to a sixth embodiment of the invention is substantially similar to the ablation occlusion device 100 of the first embodiment, except that: in the sixth embodiment, the multi-lumen tube 683 defines a through hole 683H along the axial direction of the blocking member 110, and the central passage 110H communicates with the through hole 683H to form a through passage. The through passage is used to pass an external device, the distal end of which is used to protrude from the distal end of the occluding member 110. In particular, the external device may be a mapping piece 900, a partial section of the mapping piece 900 being used for insertion into the occluding piece 100, the distal end of the mapping piece 900 emerging from the distal end of the occluding piece 110 for acquiring electrophysiological signals in the left atrial appendage tissue.

The present application further provides an ablation occlusion system comprising an ablation occlusion device 600, comprising an ablation occlusion device 600 and a mapping member 900. A partial section of the mapping element 900 is movably disposed through the through-passage, i.e., the central passage 110H of the occluding element 110 and the through-hole 683H of the multi-lumen tube 683, with the distal end of the mapping element 900 protruding from the distal end of the occluding element 110 to monitor electrophysiological signals within the left atrial appendage.

In this embodiment, through hole 683H is opened in the central axis direction of multi-lumen tube 683, and several housing lumens 684 of multi-lumen tube 683 are distributed around the circumference of through hole 683H. In this embodiment, by setting the mapping component 900, before ablation, an intracardiac electrophysiological signal can be collected and transmitted to the electrocardiograph synchronizer, and a parameter of pulse energy is adjusted according to a display result of the electrocardiograph synchronizer, so that pulse output of the ablation electrode 121 is controlled to be synchronized in an absolute refractory period of myocardial contraction, thereby avoiding heart rate interference and reducing sudden arrhythmia; after ablation is complete, intracardiac electrophysiological signals can also be collected by the mapping engine 900 to determine if the tissue is completely electrically isolated.

In the free state, the distal portion of the mapping member 900 may be a ring-shaped structure or a rod-shaped structure with a certain deflection angle, or a tip with a bending toward the proximal end, which is not limited herein. The mapping member 900 is preferably made of a memory alloy such as nitinol, and the distal end of the mapping member 900 may be restored to a free state after extending beyond the distal end of the occluding member 110.

Referring to fig. 15 and 16, an ablation occlusion device 700 according to a seventh embodiment of the invention is substantially similar to the ablation occlusion device 300 of the third embodiment, except that: in the seventh embodiment, the multi-lumen tube 783 is provided with a through hole along the axial direction of the blocking member 310, and the ablation blocking device 700 includes a pulling member 770 movably disposed through the through channel, that is, the pulling member 770 is movably disposed through the central channel 310H of the blocking member 310 and the through hole 783H of the multi-lumen tube 783. The distal end of the pull member 770 is removably attached to the connector 319 at the distal end of the occluding member 310. In this embodiment, the connecting member 319 of the distal end of the blocking member 310 is internally threaded, and the pulling member 770 is threadedly connected to the connecting member 319, specifically, the pulling member 770 is a steel cable or a hollow tube having a threaded connector at the distal end. It will be appreciated that when the pull member 770 is axially displaced relative to the block piece 310, the pull member 770 is able to pull the block piece 310 to deform axially, causing the axial dimension as well as the radial dimension of the block piece 310 to change. The blocking piece 310 is compressed or stretched along the axial direction, so that the radial dimension of the blocking piece 310 is changed, the radial diameter of the blocking piece 310 is adjusted, the fit degree of the ablation piece 320 on the blocking piece 310 and the inner wall of the left atrial appendage during ablation is adjusted, and the ablation effect is improved. After ablation, the pulling member 770 is disconnected from the connecting member 319, and the pulling member 770 is withdrawn from the body.

It can be understood that, on the basis of the fifth embodiment, a corresponding improvement design may also be made, for example, the first connector 542 is provided with a first through hole along the axial direction of the plugging member 510, the second connector 552 is provided with a second through hole along the axial direction of the plugging member 510, and the central passage 110H, the first through hole and the second through hole are communicated to form a through passage. The use of the through channel is described with reference to the sixth and seventh embodiments, i.e., for penetrating the mapping 900 or the pulling 770.

The foregoing is an embodiment of the present invention, and it should be noted that specific technical solutions in the foregoing embodiments can be mutually applied without departing from the technical principle of the present application, and it is obvious to those skilled in the art that several modifications and embellishments can be made without departing from the principle of the embodiment of the present invention, and these modifications and embellishments are also regarded as the protection scope of the present invention.

Claims

1. An ablation blocking device comprises a blocking piece for blocking a left atrial appendage and a conveyor for conveying the blocking piece to the left atrial appendage, and is characterized in that the ablation blocking device further comprises an ablation piece arranged on the blocking piece, a first conductive assembly is arranged on the ablation piece, the conveyor is correspondingly provided with a second conductive assembly electrically connected to an external ablation signal source, the first conductive assembly can be electrically connected to the second conductive assembly in a detachable mode, and the ablation piece is used for transmitting ablation energy output by the external ablation signal source to ablate the left atrial appendage.

2. The ablation occlusion device of claim 1, wherein the ablating member includes at least one ablating electrode therein, the first electrically conductive element includes at least one first conductive wire, each ablating electrode is interconnected with a corresponding first conductive wire, and the second electrically conductive element includes at least one second conductive wire, each first conductive wire is interconnected with a corresponding second conductive wire.

3. The ablation occlusion device of claim 2, wherein the occlusion piece includes a support frame having a surface defining at least one wire groove, each of the wire grooves extending in a direction of a corresponding first wire and adapted to receive a corresponding first wire.

4. The ablation occlusion device of claim 2, further comprising a multi-lumen tube of insulating material, the multi-lumen tube including at least one axially extending receiving lumen, each receiving lumen for receiving an end of a corresponding first wire and a corresponding second wire that are connected to each other.

5. The ablation occlusion device of claim 4, wherein the second conductive element further comprises at least one conductive tube made of a conductive material, each conductive tube being received in a corresponding receiving cavity, a distal end of each conductive tube being movably connected to a proximal end of a corresponding first wire, and a proximal end of each conductive tube being connected to a distal end of a corresponding second wire;

and in the process that each second lead wire drives the corresponding conductive tube to move towards the near end relative to the plugging piece, the corresponding conductive tube is separated from the far end of the first lead wire contained in the conductive tube.

6. The ablation occlusion device of claim 5,

the multi-cavity tube is fixedly arranged on the outer surface of the at least one conductive tube and moves synchronously along with the at least one conductive tube; or

The multi-cavity tube is fixedly arranged on the blocking piece, and the multi-cavity tube is separated from the at least one conductive tube in the process of moving towards the near end.

7. The ablation occlusion device of claim 4 or 5, wherein the occlusion element comprises a support frame, the support frame comprises a central passage extending axially through both ends of the support frame, the multilumen tubing is provided with a through hole along the axial direction of the occlusion element, and the central passage is communicated with the through hole to form a through passage.

8. The ablation occlusion device of claim 7, wherein the through passage is configured to pass an external device, a distal end of the external device being configured to extend from a distal end of the occlusion piece; alternatively, the first and second electrodes may be,

the distal end of shutoff piece includes the connecting piece, it wears to locate still including activity the tractive piece of wearing to establish in the passageway, the distal end of tractive piece can dismantle connect in the connecting piece of shutoff piece distal end, the tractive piece is used for driving the distal end of shutoff piece is along axial displacement, makes the axial dimensions and the radial dimension of shutoff piece change.

9. The ablation occlusion device of claim 2, wherein the first electrically conductive component comprises a first connector coupled to an end of at least one first wire distal to the ablating member, the second electrically conductive component comprises a second connector coupled to an end of at least one second wire distal to the source of the external ablation signal, the first connector being in pluggable connection with the second connector,

and a plurality of conductive circuits are arranged in the first connector and the second connector so as to conduct corresponding electric signals in the first conductive wire and the second conductive wire.

10. The ablation occlusion device of claim 9, wherein the occlusion element comprises a support frame, the support frame comprises a central channel extending axially through both ends, the first connector defines a first through hole along an axial direction of the occlusion element, the second connector defines a second through hole along the axial direction of the occlusion element, and the central channel, the first through hole and the second through hole are communicated to form a through channel.

11. The ablation occlusion device of claim 10, wherein the through passage is configured to pass an external device, a distal end of the external device being configured to extend from a distal end of the occlusion piece; alternatively, the first and second electrodes may be,

the far end of the plugging piece comprises a connecting piece, the ablation plugging device further comprises a traction piece movably arranged in the penetrating channel in a penetrating mode, and the far end of the traction piece is detachably connected with the connecting piece at the far end of the plugging piece; the traction piece is used for driving the far end of the plugging piece to move axially, so that the axial size and the radial size of the plugging piece are changed.

12. The ablation occlusion device of claim 1, wherein the ablation energy is pulsed energy, and the ablating member comprises at least one pair of ablation electrodes, each pair of ablation electrodes comprising a positive electrode and a negative electrode.

13. The ablation occlusion device of claim 12, wherein the positive electrodes and the negative electrodes are staggered along a circumference of the occlusion member.

14. The ablation occlusion device of claim 13, wherein the ablating member defines at least one loop in a circumferential direction of the ablation occlusion device.

15. The ablation occlusion device of claim 14, wherein the ablating member defines a plurality of loops circumferentially about the ablation occlusion device, the plurality of loops being spaced axially of the ablation occlusion device.

16. The ablation occlusion device of claim 14 or 15, wherein the ablating member defines at least one pair of the ablating electrodes in each loop.

17. The ablation occlusion device of claim 1, wherein at least one flow-blocking membrane is disposed on the occlusion member.

18. The ablation occlusion device of claim 2, wherein the first lead is an extension of a corresponding ablation electrode to which it is connected.

19. The ablation occlusion device of claim 2, wherein the second wire is a tubular conductive tube, the conductive tube includes a cavity extending through both ends thereof, a distal end of each conductive tube is movably connected to a proximal end of a corresponding first wire, and a proximal end of each conductive tube is electrically connected to the external ablation signal source.

20. An ablation occlusion system comprising a mapping member and the ablation occlusion device of any of claims 1-19, a portion of the mapping member configured for insertion through a hollow occlusion member, a distal end of the mapping member exposed from the distal end of the occlusion member for acquiring electrophysiological signals in left atrial appendage tissue.