Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.
In the description of the present invention, the far end and the near end of the present invention are relative to the operator, the end of the occluder closer to the operator is the near end, and the end away from the operator is the far end. The axial direction refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis, and this definition is only for the convenience of expression and can not be understood as the limitation of the present invention.
It should be noted that the left atrial appendage in the present application includes, in addition to the interior of the left atrial appendage, a portion that connects the left atrial appendage to the left atrium.
Referring to fig. 1, fig. 1 is a schematic structural diagram of an ablation occlusion system according to a first embodiment of the present invention. The utility model provides an ablation occlusion system 100, it includes one melts occlusion device 20 and is used for carrying melt occlusion device 20 to a melting occlusion delivery device 60 of left atrial appendage. The ablation occlusion device 20 comprises an occlusion piece 22 for occluding the left atrial appendage and an ablation piece 25 arranged on the occlusion piece 22 and capable of fitting the inner wall of the left atrial appendage. The ablation part 25 is provided with a conductive wire 251, the ablation occlusion delivery device 60 is provided with a conductive wire 61, the conductive wire 251 is detachably and electrically connected to the conductive wire 61, and one end of the conductive wire 61 far away from the conductive wire 251 is electrically connected to a radio frequency power source. The ablating member 25 can receive energy from the rf power source through the conductive wire 251 and the conductive wire 61 for ablating the inner wall of the left atrial appendage. When the ablation occlusion delivery device 60 delivers the ablation occlusion device 20 to be implanted in the left atrial appendage, the outer wall surface of the occlusion piece 22 is attached to the inner wall of the left atrial appendage, the ablation piece 25 is attached to the inner wall of the left atrial appendage, and the ablation piece 25 receives the energy of the radio frequency power supply to ablate the inner wall of the left atrial appendage. After the ablation is completed, since the conductive wire 251 of the ablation member 25 can be electrically and detachably connected to the conductive wire 61, when the ablation occlusion delivery device 60 is removed, the conductive wire 251 of the ablation member 25 can be separated from the conductive wire 61 of the ablation occlusion delivery device 60 only by axially moving the conductive wire 61 towards the proximal end, so that the conductive wire 61 and the ablation occlusion delivery device 60 are removed together, and the use is convenient.
The ablation occlusion system 100 of the present invention comprises an ablation occlusion device 20 and an ablation occlusion conveying device 60 for conveying the ablation occlusion device 20, wherein the ablation occlusion device 20 comprises an occlusion piece 22 and an ablation piece 25 disposed on the occlusion piece 22; the ablation occlusion delivery device 60 delivers the ablation occlusion device 20 to the left atrial appendage, the outer wall surface of the occlusion piece 22 is attached to the inner wall of the left atrial appendage, the occlusion piece 22 is used for closing the left atrial appendage, and the ablation piece 25 is attached to the inner wall of the left atrial appendage. The ablation piece 25 is detachably and electrically connected to the conductive wire 61 through a conductive wire 251, and the proximal end of the conductive wire 61 is electrically connected to a radio frequency power supply, so that the ablation piece 25 can receive the energy of the radio frequency power supply to ablate the inner wall of the left atrial appendage, thereby increasing the cure rate of atrial fibrillation ablation. Because the conductive wire 251 of the ablating member 25 can be electrically and detachably connected to the conductive wire 61, when the ablation occlusion delivery device 60 is removed, the conductive wire 251 of the ablating member 25 can be separated from the conductive wire 61 of the ablation occlusion delivery device 60 by axially moving the conductive wire 61 towards the proximal end, and the connecting line of the conductive wire 251 and the conductive wire 61 does not need to be cut off by using an additional cutting device, so that the operation is simple and the use is convenient.
Fig. 2 is a schematic structural view of the ablation occlusion device of fig. 1, as shown in fig. 2. The block piece 22 includes a block portion 221, an anchor portion 223 provided at a distal end of the block portion 221, and a connecting portion 225 connected between the block portion 221 and the anchor portion 223. The block piece 22 is a self-expanding support scaffold which may be an elastic metal support scaffold or an elastic non-metal, e.g. polymeric, support scaffold. In this embodiment, the support frame is a nitinol stent, and when the support frame is delivered through a sheath, the diameter of the support frame may be contracted to a smaller state for delivery through the sheath; when the support framework is implanted and released in the left auricle, the support framework can be automatically expanded to the required shape and size, so that the support framework can be supported on the inner wall of the left auricle, and the support framework is right for generating the radial support effect on the inner wall of the left auricle. The plugging part 221 is used for blocking and separating the left atrium and the left auricle, so as to prevent thrombus in the left auricle from entering the left atrium; the anchoring portion 223 is used to position the closure 22 within the left atrial appendage. In each figure, the occluding member 22 and the ablating member 25 of the ablation occluding device 20 are in a free state, that is, a state in which the ablation occluding device 20 is implanted behind the left atrial appendage. For ease of delivery, both the occluding member 22 and the ablating member 25 may be radially compressed to a reduced diameter for insertion into the sheath. The location of the ablating member 25 may be selected to be on the outer wall of the occluding member 22, such as the outer peripheral surface of the anchoring portion 223, the connecting portion 225 or the occluding portion 221, depending on the particular location to be ablated. In this embodiment, the ablating member 25 is disposed on the outer wall surface surrounding the anchoring portion 223, so that the ablating member 25 can be attached to the inner wall of the left atrial appendage to be ablated.
The plugging member 22 may be woven by using a metal wire, and the plugging portion 221, the anchoring portion 223, and the connecting portion 225 may be integrally woven, or may be connected to each other after being separately woven. The plugging member 22 may be a radially compressed grid structure, a rod structure, a frame structure or a flexible foldable structure, or may be a grid or frame structure formed by cutting a metal tube. The closure 22 may also be a cylindrical structure, a frustoconical structure, a conical structure, or a combination thereof, each of which has an outer wall surface that conforms to the inner wall of the left atrial appendage. The metal wire can be nickel-titanium alloy, cobalt-chromium alloy, stainless steel or other metal materials with good biocompatibility, preferably a superelastic shape memory alloy nickel-titanium wire, and the manufacturing process of the metal wire is the same as that of the framework of the traditional left atrial appendage occluder, and is not repeated herein.
The blocking portion 221 includes a mesh frame 2212 supporting the distal end of the frame, at least one layer of flow blocking film 2214 disposed on the mesh frame 2212, and a connecting end 2216 located at the proximal end of the mesh frame 2212. The shape of the blocking portion 221 may be a disk shape, a cylindrical shape, or a stepped structure formed by combining a disk shape and a cylindrical shape. In this embodiment, the blocking portion 221 has a stepped structure formed by combining a disc shape and a cylinder shape, the grid frame 2212 is formed by weaving a superelastic shape memory alloy nickel-titanium wire, and the cylindrical weaving structure is located at a distal end of the disc-shaped weaving structure; the diameter of the cylindrical braided structure of the mesh frame 2212 is consistent with the inner diameter of the entrance of the left auricle, and the diameter of the disc-shaped braided structure is larger than the inner diameter of the entrance of the left auricle; the mesh frame 2212 can be inserted into the left atrial appendage, and specifically, when the closure 22 is implanted into the left atrial appendage, the outer wall surface of the cylindrical braided structure of the mesh frame 2212 is attached to the inner wall of the neck of the left atrial appendage, and the disc-shaped braided structure is attached to the surface of the left atrial appendage facing the left atrium.
The occlusion portion 221 seals the left atrial appendage by a flow blocking membrane 2214 disposed in the interior or on the proximal face thereof. The flow blocking film 2214 may be sewn or adhesively secured to the interior or proximal surface of the mesh frame 2212, and the flow blocking film 2214 may be selected from PET or PTFE coated films.
The connecting end 2216 is located at the center of the end face of the proximal end of the grid frame 2212, the connecting end 2216 is preferably a bolt head, the bolt head is axially provided with an internal screw hole, and the connecting end 2216 is used for being detachably connected with the ablation occlusion delivery device 60.
The anchoring portion 223 includes an anchoring body 2232 that supports a distal portion of the skeleton, and a number of anchors 2234. The anchoring body 2232 has a cylindrical structure, the diameter of the anchoring body 2232 is substantially the same as the inner diameter of the left atrial appendage, the contact between the outer wall surface of the anchoring body 2232 and the inner wall of the left atrial appendage creates friction, and the anchoring body 2232 can be used directly to anchor the ablation occlusion device 20. A plurality of anchors 2234 are disposed on the outer peripheral wall of the anchor body 2232, the anchors 2234 being for positioning the ablation occluding device 20 on the inner wall of the left atrial appendage. Specifically, the anchors 2234 are uniformly arranged around the outer wall of the anchoring main body 2232, and after the ablation occlusion delivery device 60 delivers the ablation occlusion device 20 to be implanted in the left atrial appendage, the anchors 2234 pierce the inner wall of the left atrial appendage to further anchor the ablation occlusion device 20, so that the anchoring stability is better by using the anchors 2234, and the ablation occlusion device 20 can be effectively prevented from falling off. The anchoring body 2232 of cylindrical configuration is closed at its distal end and integrally connected at its proximal end to the connecting portion 225.
The anchor 2234 and the anchor main body 2232 are an integral structure or a fixed connection structure, in this embodiment, the anchor 2234 and the anchor main body 2232 are connected together by a fixed connection method, the anchor 2234 is located at the distal end of the support frame, the number of the anchor 2234 is 5-15, the opening angle of the anchor 2234 is 30-60 °, the direction is toward the proximal end, and the length of the anchor 2234 is 0.5-4 mm. The anchoring portion 223 is provided with a barb structure, which is mainly used to strengthen and stabilize the whole ablation occlusion device 20.
A flow blocking film may be radially disposed in the anchor body 2232 of the anchor portion 223, the periphery of the flow blocking film may be fixed to the inside of the anchor body 2232 by sewing or bonding, and the flow blocking film may be a PET or PTFE film.
The connection portion 225 includes a mesh frame body between the plugging portion 221 and the anchoring portion 223 of the support frame, the mesh frame body is formed by weaving metal wires into a mutually intersecting mesh shape, and the mesh frame body is connected between the plugging portion 221 and the anchoring portion 223.
The blocking portion 221, the connecting portion 225 and the anchoring portion 223 in this embodiment are an integral structure, that is, the blocking portion 221, the connecting portion 225 and the anchoring portion 223 may be integrally formed as a support frame, or may be connected to an integrally formed metal support frame by welding or the like.
The ablation part 25 comprises at least one ablation electrode 252, and at least one ablation electrode 252 is electrically connected to the radio frequency power source through a conductive wire 251 and a conductive lead 61; when the ablation occlusion device 20 is delivered by the ablation occlusion delivery device 60 and implanted into the entrance of the left atrial appendage, at least one of the ablation electrodes 252 is attached to the inner wall of the left atrial appendage, and at least one of the ablation electrodes 252 is used for ablating the inner wall of the left atrial appendage.
The ablation electrodes 252 may be disposed on the outer peripheral wall of the occlusion portion 221, the anchoring portion 223, or the connection portion 225, the number of the ablation electrodes 252 may be one or more, and one or more ablation electrodes 252 may be disposed on the outer peripheral wall of the occlusion portion 221, the anchoring portion 223, or the connection portion 225; or on the outer peripheral walls of the blocking portion 221, the anchoring portion 223, and the connecting portion 225, respectively. Each ablation electrode 252 is provided with a conductive wire 251, which conductive wire 251 is releasably connected to the corresponding conductive wire 61, and in particular, the end of the conductive wire 251 remote from the corresponding ablation member 252 is releasably connected to the conductive wire 61 of the ablation occlusion delivery device 60.
As shown in fig. 2, the ablation electrode 252 may be a ring-shaped electrode having at least one continuous or discontinuous turn disposed along the outer wall surface of the blocking member 22, and the number of the ring-shaped electrodes may be one or more. In this embodiment, two uninterrupted ring electrodes are disposed on the outer wall surface of the anchoring portion 223, the two ring electrodes are detachably connected to the corresponding conductive wires 61 through the conductive wires 251, that is, the proximal end of each conductive wire 251 is detachably and electrically connected to the corresponding conductive wire 61, and the distal end of the conductive wire 251 is connected to the corresponding ablation electrode 252 by welding or steel sleeve fixing. The ablation electrode 252 and the anchoring portion 223 are insulated, that is, at least the portion of the grid frame 2232 that is in contact with the ablation electrode 252 is insulated, so that the rf energy can be concentrated on the ablation electrode 252 for ablation, thereby achieving a better ablation effect. The insulation treatment may be performed by coating an insulation coating on the outer wall surface of the supporting skeleton contacting the ablation electrode 252, or inserting an insulation sleeve on the metal wire contacting the ablation electrode 252, wherein the insulation sleeve is wrapped on the outer surface of the metal wire of the supporting skeleton, and the coating or sleeve material may be FEP/ETFE/PFA.
In other embodiments, each ablation electrode 252 may be at least one turn of conductive wire circumferentially surrounding the outer peripheral wall of the occluding portion 221, anchoring portion 223, or connecting portion 225 through the distal end of the corresponding conductive wire 251, and the outer surface of the at least one turn of conductive wire is exposed to metal.
In this embodiment, two ablation electrodes 252 are circumferentially disposed on the outer wall surface of the anchoring portion 223 at intervals, and each ablation electrode 252 can be electrically connected to the rf power source through the conductive wire 251 and the corresponding conductive wire 61. The polarity selection of the two ablation electrodes 252 on the anchor portion 223 includes, but is not limited to, the following three schemes:
the two ablation electrodes 252 are electrically connected to the same rf output end through the conductive wire 251 and the corresponding conductive wire 61, and the neutral electrode plate is connected to the rf input end of the rf power supply.
The two ablation electrodes 252 are electrically connected to the rf output end of the rf power source through the conductive wires 251 and the corresponding conductive wires 61, and the metal plugging member 22 is connected to the rf input end of the rf power source through the ablation plugging conveying device 60.
One of the ablation electrodes 252 is electrically connected to the rf output terminal of the rf power supply through the conductive wire 251 and the corresponding conductive wire 61, and the other ablation electrode 252 is electrically connected to the rf input terminal of the rf power supply through the conductive wire 251 and the corresponding conductive wire 61 without a neutral electrode plate.
In other embodiments, the ablation electrode 252 may be disposed on the outer wall of the occlusion portion 221 or the outer wall of the connection portion 225, e.g., the ablation electrode 252 may be circumferentially disposed on the outer wall of the cylindrical woven structure of the mesh frame 2212 of the occlusion portion 221. The ablation electrode 252 provided on the outer wall of the sealing part 221 is insulated from the sealing part 221, and the ablation electrode 252 provided on the outer wall of the connecting part 225 is insulated from the connecting part 225.
In other embodiments, the outer wall surface of the metal support skeleton may be circumferentially provided with a plurality of turns of ring-shaped electrodes, which may be continuous, or intermittent, or a combination of both; the ring electrodes of the multiple circles can be arranged in parallel or staggered in the axial direction of the metal supporting framework.
As shown in fig. 1, the ablation occlusion delivery device 60 further comprises a sheath mechanism 62, a delivery cable 64, a cable handle 642 disposed at a proximal end of the delivery cable 64, a loader 66, and a hemostatic valve 68, wherein the conductive wire 61 is disposed on the sheath mechanism 62, and the conductive wire 61 is electrically and detachably connected to the conductive wire 251 of the ablation occlusion device 20. The sheath mechanism 62 includes an inner sheath 622, an inner sheath handle 624 disposed at a proximal end of the inner sheath 622, and an outer sheath 626 disposed outside the inner sheath 622. Wherein the delivery cable 64 is movably threaded through the inner sheath handle 624 and the inner sheath 622, the inner sheath 622 and the delivery cable 64 together being connected to the ablation occlusion device 20 through the hemostasis valve 68 and the loader 66. Specifically, the distal end of the delivery cable 64 is provided with an external thread 641, the distal end of the delivery cable 64 sequentially passes through the inner sheath handle 624 and the inner sheath 622 and together with the inner sheath 622 passes through the hemostatic valve 68, the loader 66 and the outer sheath 626, the external thread 641 at the distal end of the delivery cable 64 is exposed out of the distal end surface of the outer sheath 626, the external thread 641 corresponds to the internal thread of the connecting end 2216 of the block piece 22, that is, the external thread 641 is detachably connected to the internal thread of the connecting end 2216.
Fig. 3 is a partially enlarged view of the inner sheath tube in fig. 1, as shown in fig. 3. The conveying steel cable 64 is accommodated in an inner sheath tube 622, the inner sheath tube 622 comprises an inner layer 6221 attached to the outer peripheral surface of the conveying steel cable 64 and an outer layer 6223 wrapped outside the inner layer 6221, the conductive wires 61 are arranged between the inner layer 6221 and the outer layer 6223 of the inner sheath tube 622, each conductive wire 61 axially penetrates through the inner sheath tube 622, the distal ends of the conductive wires 61 can be electrically connected to the corresponding conductive wires 251 in a detachable manner, and the proximal ends of the conductive wires 61 are electrically connected to a radio frequency power supply after extending out of an inner sheath tube handle 624.
In this embodiment, the conductive wire 61 and the inner sheath 622 are integrally formed, that is, the conductive wire 61 is fixed on the inner sheath 622, and when the inner sheath 622 is removed, the inner sheath 622 drives the conductive wire 61 to move and separate from the connection with the conductive wire 251. The outer surface of the conductive wire 61 is insulated except for the proximal end and the distal end by means of an insulating coating, an insulating sleeve, or the like on the outer surface of the conductive wire 61.
In other embodiments, the inner sheath 622 has a slot axially formed in a side wall thereof, and the conductive wire 61 is fixed in the slot.
Referring to fig. 2 and 4 together, fig. 4 is a partially enlarged view of the connection manner of the conductive wire and the ablation electrode in fig. 2. The distal end of each conductive wire 61 is electrically connected to the proximal end of the corresponding conductive wire 251 through a fixing member 69. In this embodiment, the fixing element 69 is an insulating heat shrink tube, that is, the connection between the conductive wire 61 and the corresponding conductive wire 251 is fixed by heat shrink tube. Specifically, one end of the heat shrinkable tube is fixedly connected to the far end of the conductive wire 61, and the far end of the conductive wire 61 is provided with a first connecting section 612 with exposed metal; the outer surface of the conductive wire 61 except the first connecting section 612 and the near end connected with the radio frequency power supply is insulated; the first connecting section 612 is accommodated in the heat shrinkable tube, and the first connecting section 612 is fixed in the heat shrinkable tube, that is, when the inner sheath tube 622 is removed, the heat shrinkable tube and the conductive wire 61 are evacuated together. A second connection section 2512 with exposed metal is arranged at the proximal end of the conductive wire 251, the outer surface of the conductive wire 251 except the second connection section 2512 and the far end contacted with the ablation electrode 252 is subjected to insulation treatment, and the second connection section 2512 is contained in the heat shrinkage tube; by the fixing and accommodating action of the fixing element 69, the second connecting section 2512 of the conductive wire 251 is electrically connected to the first connecting section 612 of the conductive wire 61 in a mutual contact manner, so that the radiofrequency energy can be transmitted to the ablation electrode 252; the outer surfaces of the conductive wire 251 and the conductive wire 61 except the contact surfaces of the first connecting section 612 and the second connecting section 2512 are subjected to insulation treatment, so that the blocking ablation device 20 is prevented from conducting electricity in the areas except the ablation electrode, energy dissipation is reduced, and ablation effect is guaranteed. The outer surfaces of the conductive wires 61 and 251 may be insulated by an insulating coating or an insulating sleeve coated with a polymer insulating material, preferably PTFE, FEP, ETFE, PFA or PEEK (polyether ether ketone) sleeve.
The connection segments 2512 of the conductive wires 251 can be connected to the connection segments 612 of the corresponding conductive wires 61 in a parallel contact manner, a winding contact manner, a penetrating contact manner or a cross contact manner. The connection mode can realize the energy transmission between the conductive wire 61 and the conductive wire 251 on the ablation electrode 252, meanwhile, the conductive wire 251 and the conductive wire 61 are not completely fixedly connected, and can be separated under a certain load, so that the ablation occlusion device 20 is separated from the ablation occlusion conveying device 60, and the ablation occlusion device 20 is left in a designated area, thereby achieving the effects of ablation and occlusion.
In this embodiment, the connection segment 2512 of the conductive wire 251 is connected to the corresponding connection segment 612 of the conductive wire 61 in a winding contact manner, so that the conductive wire 251 is electrically connected to the conductive wire 61, and the connection segment 2512 of the conductive wire 251 can be separated from the connection segment 612 of the conductive wire 61 under the action of a certain external force.
When the ablation occlusion system 100 is used, the connecting end 2216 on the occlusion part 221 can be connected with the external thread 641 at the distal end of the delivery cable 64 of the ablation occlusion delivery device 60 in a bolt mode during the operation, the inner sheath 622 and the delivery cable 64 can be locked by the screwing device 6242 of the inner sheath handle 624, the inner sheath handle 624 is pulled backwards, the delivery cable 64 and the inner sheath 622 move together to fully retract the ablation occlusion device 20 into the loader 66, the loader 66 is connected with the outer sheath 626, and the ablation occlusion device 20 can be compressed and pushed into the outer sheath 626 by pushing the inner sheath handle 624; the sheath 626 is inserted into the inferior vena cava, into the right atrium, and into the left atrium by femoral vein insertion, and then inserted into the left atrium by interatrial septum insertion, and the ablation occlusion device 20 is released into the left atrial appendage along the delivery channel established by the sheath 626. When the ablation occlusion device 20 is released, the position of the ablation occlusion device 20 in the left atrial appendage is positioned by means of radiography and ultrasound so as to ensure that the anchoring part 223 is released in the left atrial appendage after the release, and the anchor 2234 is hooked into the inner wall of the left atrial appendage, so that the ablation electrode 252 is attached to the inner wall of the left atrial appendage; the outer wall of the cylindrical braided structure of the occlusion part 221 is attached to the inner wall of the left auricle, and the disc-shaped braided structure of the occlusion part 221 is attached to the surface of the left auricle facing the left atrium; the flow blocking film 2214 in the plugging part 221 plugs the left atrial appendage to prevent blood flow from entering the left atrial appendage and thrombus from flowing into the left atrial appendage. After the ablation occlusion device 20 is released in the left atrial appendage, the inner sheath 622 is fixed through the hemostatic valve 68 connected with the loader 66, the conductive wire 61 connected with the ablation electrode 252 is connected with a radio frequency source, the radio frequency ablation parameters are adjusted, and the radio frequency ablation energy is transmitted to the ablation electrode 252 through the conductive wire 61 and the corresponding conductive wire 251, so that the ablation operation, namely the ablation operation is performed on the inner wall of the left atrial appendage attached to the ablation electrode 252. The utility model provides an it melts plugging device 20 can utilize in an operation to melt plugging device 20 self structure and successively realize melting completely to the inner wall of left auricle and block to the shutoff of the entry of left auricle and efficient realization to the sinus rhythm of heart resumes.
The process of withdrawing the ablation occlusion delivery device 60 after ablation is complete is as follows: the closure 22 can be released by loosening the tightening device 6242 of the inner sheath handle 624 and rotating the cable handle 642 to rotate the delivery cable 64 out of engagement with the attachment end 2216 of the closure 22, i.e., the external threads 641 at the distal end of the delivery cable 64 are disengaged from the internal threads of the attachment end 2216. When the inner sheath tube 622 and the conveying steel cable 64 are withdrawn, the inner sheath tube 622 can drive the conductive wire 61 to be withdrawn together, at this time, the conductive wire 61 and the conductive wire 251 start to be separated under the action of tension, that is, the conductive wire 251 is separated from the fixing piece 69, the fixing piece 69 connected with the conductive wire 61 is also withdrawn out of the body along with the withdrawal of the conductive wire 61, the electrode is released, and the purpose of releasing the ablation blocking and conveying device 60 and the ablation blocking and conveying device 20 is achieved.
The utility model discloses an melt shutoff conveyor 60 need not use in addition the shedder to realize the liberation of the wire of ablating the electrode at the in-process of withdrawing from, conveniently withdraws from and melts shutoff conveyor 60, easy operation, convenient to use, and has left out the shedder, has reduced the manufacturing cost who melts plugging system 100, has simplified operation flow.
Referring to fig. 5, fig. 5 is a partially enlarged view of another connection manner of the conductive wire and the ablation electrode in fig. 4. The other connection manner of the conductive wire 61 and the corresponding conductive wire 251 is similar to that in the first embodiment, except that: in the other connection manner, the connection segment 612 of the conductive wire 61 is connected to the connection segment 2512 of the conductive wire 251 in a parallel contact manner, so that the conductive wire 251 and the conductive wire 61 are electrically connected in the fixing element 69, and the second connection segment 2512 of the conductive wire 251 can be separated from the first connection segment 612 of the conductive wire 61 under the action of a certain external force. The parallel contact means that the first connection section 612 of the conductive wire 61 and the second connection section 2512 of the conductive wire 251 are attached together along the length direction of the line.
Referring to fig. 6, fig. 6 is a partially enlarged view of another connection mode between the conductive wire and the ablation electrode in fig. 4. The conductive wire 61 and the corresponding conductive wire 251 are connected in a similar manner to the first embodiment, except that: in the further connection manner, the fixing element 69a between the first connection segment 612 of the conductive wire 61 and the second connection segment 2512 of the conductive wire 251 is made of medical glue, that is, the first connection segment 612 of the conductive wire 61 and the second connection segment 2512 of the conductive wire 251 are connected by medical glue at the electrical contact point. The outer surfaces of the first and second connection segments 612 and 2512 are insulated except for the electrical contacts. The first connection segment 612 of the conductive wire 61 and the second connection segment 2512 of the conductive wire 251 may be arranged in parallel or in a winding manner. The conductive wire 251 and the conductive wire 61 can be electrically connected at the electrical contact point in the medical adhesive by the medical adhesive at the electrical contact point of the first and second connection sections 612, 2512, and the second connection section 2512 of the conductive wire 251 can be separated from the first connection section 612 of the conductive wire 61 under the action of a certain external force.
In another embodiment of the present invention, the ablation electrode 252 is releasably secured to the occlusion ablation device, and the conductive wire 251 is secured to the securing member 69 to allow removal of the ablation electrode 252 by application of an external force after ablation is complete.
Referring to fig. 7 to 9, fig. 7 is a schematic structural view illustrating an electrical contact between a conductive wire and an ablation electrode of an ablation occlusion system according to a second embodiment of the present invention; fig. 8 is an enlarged view of a portion VIII in fig. 7; FIG. 9 is an enlarged view of the metal cage of FIG. 7; the utility model discloses the structure of the ablation occlusion system that the second embodiment provided is similar with the structure of the first embodiment, and the difference lies in: the structure of the fixing member 69b between the conductive wire 61 and the corresponding conductive wire 251 in the second embodiment is different from that of the fixing member 69 in the first embodiment. In the second embodiment, the fixing element 69b is a cage-shaped metal framework, the distal end of the conductive wire 61 is fixedly connected to the cage-shaped metal framework, and the outer surface of the cage-shaped metal framework is not subjected to insulation treatment, that is, the cage-shaped metal framework is a bare metal braided framework, and the conductive wire 61 is electrically connected to the cage-shaped metal framework; the conductive wire 251 is detachably wound on the cage-shaped metal framework, and specifically, the second connection section 2512 with exposed metal on the conductive wire 251 is detachably wound on the cage-shaped metal framework, so that the conductive wire 251 is electrically connected with the conductive wire 61, and the second connection section 2512 of the conductive wire 251 can be separated from the cage-shaped metal framework under the action of a certain external force.
A gap 645 is formed between the inner sheath 622 and the conveying steel cable 64 inserted into the inner sheath 622 in a sliding manner, the cage-shaped metal framework is accommodated in the gap 645, and the inner sheath 622 and the conveying steel cable 64 extrude the cage-shaped metal framework to compress the cage-shaped metal framework, so that the wires of the cage-shaped metal framework clamp the conductive wire 251, and the movement of the connecting section 2512 of the conductive wire is limited, so that the conductive wire 251 and the cage-shaped metal framework are stably and electrically connected.
The cage-shaped metal framework can be in a shuttle shape or an oval shape, the cage-shaped metal framework can be formed by weaving elastic metal wires, and the cage-shaped metal framework can be in a radial compressible latticed structure and can also be in a latticed structure formed after a metal pipe is cut. The metal wire can be nickel-titanium alloy, cobalt-chromium alloy, stainless steel or other metal materials with good biocompatibility, and is preferably a superelastic shape memory alloy nickel-titanium wire.
The cage-shaped metal framework can also be a cylindrical grid structure, a circular truncated cone-shaped grid structure, a conical grid structure or a combination of the cylindrical grid structure, the connecting section 2512 of the conducting wire 251 can be wound in the grid structures in a releasable way; besides the regular structure, the cage-shaped metal framework can also have a random structure.
The proximal end of the conductive wire 61 is externally connected to a handle locking device, and the conductive wire 61 is free to move in the gap 645 between the inner sheath 622 and the delivery cable 64 before locking. The outer surface of the conveying steel cable 64 is subjected to insulation treatment, and the outer surface of the conductive wire 61 is subjected to insulation treatment except for the connection part with the cage-shaped metal framework, and the insulation treatment mode is the same as that in the first embodiment, and is not described herein again.
In this embodiment, the conductive wire 61 and the conductive wire 251 are electrically connected to a shuttle-shaped cage-shaped metal frame knitted from a memory alloy and having good conductivity at the distal end of the conductive wire 61, the cage-shaped metal frame and the conductive wire 61 are fixedly connected into a whole, and the exposed metal connecting section 2512 of the conductive wire 251 is detachably wound on the cage-shaped metal frame. That is, the conductive wire 251 of the ablation electrode 252 on the blocking member 22 penetrates through the cage-shaped metal framework capable of conducting electricity, and is compressed and fixed in the gap 645 together with the cage-shaped metal framework, so that the ablation electrode 252 can be smoothly and electrically connected to the rf power source through the conductive wire 251 and the corresponding conductive wire 61.
Since the fixing member 69b is a radially extendable and retractable shuttle-shaped cage-shaped metal frame, the cage-shaped metal frame can limit the connecting section 2512 of the conductive wire 251 inserted into the meshes of the cage-shaped metal frame, when the conductive wire 61 is pulled backward, the cage-shaped metal frame of the shuttle-shaped structure can smoothly accommodate the cage-shaped metal frame at the distal end of the conductive wire 61 and the second connecting section 2512 of the conductive wire 251 into the gap 645 between the inner sheath tube 622 and the steel conveying cable 64, and the diameter of the cage-shaped metal frame is contracted and compressed under the extrusion of the inner sheath tube 622 and the steel conveying cable 64, so that the cage-shaped metal frame can be sufficiently contacted with the connecting section 2512 inserted into the meshes of the cage-shaped metal frame, and smooth energy transmission can be performed. The compressible design of the cage allows the cage to occupy less space, i.e., less space is required in the radial direction occupied by the gap 645 between the inner sheath 622 and the steel delivery cable 64, and thus, the diameter of the inner sheath 622 need not be changed.
When in use, the cage-shaped metal framework and the connecting section 2512 of the conducting wire 251 are pulled into the gap 645 between the inner sheath tube 622 and the steel conveying steel cable 64; the connecting end 2216 on the plugging part 221 is connected with the distal external thread 641 of the delivery steel cable 64 of the ablation plugging delivery device 60 in a bolt mode; the inner sheath tube 622 and the delivery cable 64 can be locked by the screwing device of the inner sheath handle, and the delivery cable 64 and the inner sheath tube 622 can move together by pulling the inner sheath handle backwards, so that the ablation blocking device 20 can be completely retracted into the loader. The loader is connected to the outer sheath, pushing the inner sheath handle compresses the ablation occlusion device 20 into the outer sheath, and the delivery channel established along the outer sheath releases the ablation occlusion device 20 to the left atrial appendage. After the ablation occlusion device 20 is released, the inner sheath 622 is fixed through a hemostatic valve connected with the loader, and the radiofrequency ablation instrument electrically connected with the ablation electrode 252 is turned on, so that the ablation electrode 252 ablates the inner wall of the left atrial appendage. After the ablation is finished, the screwing device of the inner sheath handle is loosened, and the screwing device rotates to drive the conveying steel cable 64 to rotate, so that the conveying steel cable 64 is separated from the plugging piece 22; the steel delivery cable 64 is withdrawn backwards, when the steel delivery cable 64 releases the extrusion on the cage-shaped metal framework, the cage-shaped metal framework is unfolded to release the limitation on the connecting section 2512 of the conductive wire 251, and the conductive wire 61 is pulled backwards to separate the shuttle-shaped cage-shaped metal framework from the connecting section 2512 of the conductive wire 251 and withdraw together with the ablation occlusion delivery device 60, so that the purpose of releasing the ablation occlusion delivery device 60 and the ablation occlusion device 20 is achieved.
The utility model discloses an melt shutoff conveyor is at the in-process of withdrawing from, does not need to use in addition that cutting device realizes the liberation of electrode, conveniently withdraws from and melts shutoff conveyor 60, easy operation, convenient to use, and has left out cutting device, has reduced the manufacturing cost who melts shutoff system 100, has simplified operation flow.
Referring to fig. 10, fig. 10 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to a third embodiment of the present invention. The utility model discloses the structure of the ablation plugging device of the ablation plugging system that the third embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the third embodiment, the blocking portion 221 of the blocking member 22 is a disk-shaped structure, and the ablating member 25 includes at least one circle of dot-shaped electrodes 252 disposed on the outer wall surface of the blocking member 22 and capable of fitting to the inner wall of the left atrial appendage. Specifically, these spot-like electrodes 252 are provided at least one turn along the outer wall surface of the anchor body 2232 of the anchor portion 223. Each dot-shaped electrode 252 and the anchor portion 223 are insulated by coating an insulating coating on the outer wall surface of the anchor portion 223 contacting the dot-shaped electrode 252, or by inserting an insulating sleeve on the wire where the anchor portion 223 and the dot-shaped electrode 252 contact. The point-like electrodes 252 can be used as ablation electrodes, that is, the electrodes are connected with the output end of the radio frequency source; it can also be used as a grounding electrode, i.e. the electrode is connected with the input end of the radio frequency source. The point electrodes 252 are connected in series by a conductive wire and then connected to the conductive wire 251, the conductive wire 251 is detachably and electrically connected to the corresponding conductive wire 61 by a fixing member 69, and the proximal end of the conductive wire 61 is connected to the rf power output terminal or the rf power input terminal.
In other embodiments, at least one circle of the dot-shaped electrodes 252 may be disposed on the outer wall surface of the mesh frame 2212 of the blocking portion 221.
Referring to fig. 11, fig. 11 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to a fourth embodiment of the present invention. The fourth embodiment of the present invention provides an ablation occlusion system having a structure similar to that of the third embodiment, except that: one of the ablation electrodes 252 in the fourth embodiment comprises a plurality of spaced rod-shaped electrodes 252, each rod-shaped electrode 252 extends in the axial direction of the occluding member 22, and the rod-shaped electrodes 252 are arranged at least one turn in the circumferential direction of the outer wall surface of the occluding member 22. Specifically, these rod electrodes 252 are provided at least one turn along the outer wall surface of the anchoring body 2232 of the anchoring portion 223. Each rod-shaped electrode 252 is insulated from the anchoring portion 223, that is, each rod-shaped electrode 252 is insulated from the outer wall surface of the anchoring body 2232 by coating an insulating coating on the outer wall surface of the anchoring body 2232 contacting the rod-shaped electrode 252 or by inserting an insulating sleeve on the wire of the anchoring body 2232 contacting the rod-shaped electrode 252. The rod electrodes 252 can be used as ablation electrodes or grounded electrodes, the rod electrodes 252 are connected in series by a conducting wire 251, the conducting wire 251 is electrically and detachably connected to the corresponding conducting wire 61 by the fixing element 69, and the proximal end of the conducting wire 61 is connected to the rf power output end or the rf power input end.
In other embodiments, at least one turn of the rod-shaped electrodes 252 may be disposed on the outer wall surface of the mesh frame 2212 of the blocking portion 221.
Referring to fig. 12, fig. 12 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to a fifth embodiment of the present invention. The utility model discloses the structure of the ablation plugging device of the ablation plugging system that the fifth embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the fifth embodiment, the blocking portion 221 of the blocking member 22 has a disk-shaped structure, wherein one ablation electrode 252 is a single-turn discontinuous ring-shaped electrode disposed on the outer wall of the blocking member 22 in the circumferential direction, the single-turn discontinuous ring-shaped electrode is insulated from the blocking member 22, and the insulation treatment between the single-turn discontinuous ring-shaped electrode and the blocking member 22 is the same as the insulation treatment between the ablation electrode 252 and the anchoring portion 223 in the first embodiment. The single-turn discontinuous ring-shaped electrode is connected in series through a conducting wire and then connected to the conducting wire 251, the conducting wire 251 is detachably and electrically connected to the corresponding conducting wire 61 through a fixing piece 69, and the proximal end of the conducting wire 61 is connected to the output end or the input end of the radio frequency power supply.
In other embodiments, the single-turn discontinuous ring-shaped electrode may be disposed on the outer wall surface of the mesh frame 2212 of the blocking portion 221.
Referring to fig. 13, fig. 13 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to a sixth embodiment of the present invention. The utility model discloses the structure of the ablation plugging device of the ablation plugging system that the sixth embodiment provided is similar to the structure of the first embodiment, and the difference lies in: the occluding part 221 of the occluding member 22 in the sixth embodiment has a disk-like structure, and the occluding member 22 is provided with an insulating coating 255 that insulates the ablation electrode 252 from the occluding member 22 at least at the outer wall surface that is in contact with the ablation electrode 252. Specifically, an annular insulating coating 255 is wrapped between the outer wall surface of the anchoring body 2232 of the anchoring portion 223 and the contact surface of the ablation electrode 252, so that energy can be gathered between the two ablation electrodes 252, the ablation effect of the ablation piece 25 can be improved, and the current damage to other parts of the heart and other tissues can be reduced.
In other embodiments, the outer wall surfaces of the blocking portion 221, the connecting portion 225 and the anchoring portion 223 are all wrapped with insulating coatings, and the ablation electrode 252 may be circumferentially disposed on the outer wall surfaces of the blocking portion 221 and the connecting portion 225.
Referring to fig. 14, fig. 14 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to a seventh embodiment of the present invention. The utility model discloses the structure of the ablation plugging device of the ablation plugging system that the seventh embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the seventh embodiment, the blocking portion 221 of the blocking member 22 and the anchoring portion 223 disposed at the distal end of the blocking portion 221 are integrated into a single structure, and the distal end of the anchoring portion 223 is a closed structure and is constricted by a sealing head 2235. The blocking member 22 is an integrally woven or cut self-expanding support scaffold, which may be an elastic metal support scaffold or an elastic non-metal, e.g. polymeric, support scaffold. The blocking piece 22 is provided with an ablation part 25, the ablation part 25 is provided with at least one ring of annular electrodes 252, and at least the outer wall surface contacted with the ablation electrodes 252 is provided with an insulating coating for isolating the ablation electrodes 252 from the blocking piece 22. Thus, energy can be focused between the two ablation electrodes 252, thereby improving the ablation effect of the ablating member 25 and reducing current damage to other portions of the heart and other tissue.
Referring to fig. 15, fig. 15 is a schematic structural view of an ablation occlusion device of an ablation occlusion system according to an eighth embodiment of the present invention. The utility model discloses the structure of the ablation plugging device of the ablation plugging system that the eighth embodiment provided is similar to the structure of the first embodiment, and the difference lies in: in the eighth embodiment, the blocking portion 221 of the blocking piece 22 and the anchoring portion 223 disposed at the distal end of the blocking portion 221 are of an integral structure, and the distal end of the anchoring portion 223 is of an open structure. The blocking member 22 is an integrally woven or cut self-expanding support scaffold, which may be an elastic metal support scaffold or an elastic non-metal, e.g. polymeric, support scaffold. The blocking piece 22 is provided with an ablation part, the ablation part is provided with at least one ring of annular electrodes 252, and at least the outer wall surface contacted with the annular electrodes 252 is provided with an insulating coating isolating the annular electrodes 252 from the blocking piece 22. Thus, energy can be concentrated on the ring-shaped electrode 252, so that the ablation effect of the ablation portion can be improved, and the damage of the current to other parts of the heart and other tissues can be reduced.
The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.