CN112998838A - Plugging ablation device - Google Patents

Plugging ablation device Download PDF

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Publication number
CN112998838A
CN112998838A CN201911322004.0A CN201911322004A CN112998838A CN 112998838 A CN112998838 A CN 112998838A CN 201911322004 A CN201911322004 A CN 201911322004A CN 112998838 A CN112998838 A CN 112998838A
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CN
China
Prior art keywords
electrode
sub
sheath
ablation
electrodes
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CN201911322004.0A
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Chinese (zh)
Inventor
唐闽
王永胜
王坤
刘成
李建民
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Hangzhou Dinova EP Technology Co Ltd
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Hangzhou Nori Medical Technology Co ltd
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Priority to CN201911322004.0A priority Critical patent/CN112998838A/en
Publication of CN112998838A publication Critical patent/CN112998838A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar

Abstract

The application discloses a plugging ablation device, which comprises a supporting framework attached to the inner wall of a left auricle, wherein the supporting framework comprises an anchoring part, a sealing part and an ablation part, and the ablation part is provided with an electrode; the electrodes comprise at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected with two poles of a pulse source; the electrode can transmit high-voltage pulse energy to form an annular ablation area. Wherein sealing is used for carrying out the shutoff with left auricle, and anchoring part is used for fixing whole device in the inside of left auricle, blocks left auricle inner wall electrophysiological signal completely, reaches the purpose of recovering the sinus rate, and sealing carries out the shutoff with left auricle, reaches the purpose of apoplexy prevention. Therefore, the operation instrument can be used for simultaneously performing pulse ablation treatment and left atrial appendage occlusion, the operation instrument can also play roles in sinus rhythm recovery and stroke prevention, and the problems that in the prior art, an operation needs to be separately performed and two instruments need to be used are solved.

Description

Plugging ablation device
Technical Field
The application relates to the field of medical equipment, in particular to a plugging ablation device.
Background
Atrial fibrillation (short for atrial fibrillation) is the most common persistent arrhythmia, and the incidence rate of atrial fibrillation is increased continuously with the increase of age, and the population over 75 years old can reach 10 percent. The exciting frequency of the atria during atrial fibrillation reaches 300-600 times per minute, the heartbeat frequency is often fast and irregular and sometimes reaches 100-160 times per minute, the heartbeat is much faster than that of a normal person and is absolutely irregular, and the atria lose effective contraction function.
At present, the main mode for treating atrial fibrillation is ablation therapy, and the ablation therapy comprises thermal ablation (radio frequency ablation, laser ablation, microwave ablation, thermal substance ablation and the like) and pulse ablation by utilizing the principle of bioelectricity perforation. After thermal ablation or pulse ablation treatment, atrial fibrillation of a patient is typically effectively treated, i.e., the patient may recover a sinus rhythm.
Due to its special shape and structure, the Left Atrial Appendage (LAA) is not only the most important site for thrombus formation in atrial fibrillation (atrial fibrillation), but also one of the key areas for the generation and maintenance of atrial fibrillation, and clinical studies show that: patients with non-valvular atrial fibrillation with thromboembolic events had 90% of their thrombus origin from the left atrial appendage. The left atrial appendage occlusion is to close the root part of thrombus generation of patients with atrial fibrillation, namely the left atrial appendage, so as to reduce the stroke risk of the patients with atrial fibrillation. Therefore, the plugging of the left auricle has milestone significance for preventing thrombus of patients with non-valvular atrial fibrillation, and the purpose of preventing stroke caused by thrombus falling in the left auricle is achieved by isolating the left atrium from the left auricle. Therefore, in order to prevent atrial fibrillation thromboembolism, the existing operator plugs LAA through the plugging device, so that the atrial fibrillation thromboembolism is prevented, and the stroke prevention function is also realized.
From the overall height of atrial fibrillation treatment, the importance of sinus rhythm recovery and stroke prevention is not primary and secondary, and currently, an operator combines occlusion treatment and ablation treatment, so that the aims of sinus rhythm recovery and stroke prevention are fulfilled. However, the current combined treatment method needs two instruments, namely an occluder and an ablation catheter, and is very complicated to operate. Generally, one can choose to occlude and then ablate, or ablate and then occlude. The mode of plugging and then ablating is adopted, the plugging device is firstly used for plugging, then the ablation catheter is placed in a body for ablating, the two-step operation is needed, time is consumed, and meanwhile, the accident that the ablation catheter damages the plugging device is avoided during the operation, so the operation difficulty is high. If the mode of ablating firstly and then plugging is adopted, the ablation operation can cause temporary damage to the mouth part of the left auricle, so that local tissue swelling is caused, and leakage can occur when the left auricle is plugged, so that plugging failure is caused. Therefore, there is an urgent need for a medical device capable of solving the above problems.
Disclosure of Invention
An object of the application is to provide a shutoff ablation device to solve above-mentioned problem, use an instrument to realize melting treatment and shutoff treatment, and melt the treatment and can block off left atrial appendage inner wall electrophysiological signal completely, simplify operation process, increase operation factor of safety.
The plugging ablation device comprises a supporting framework attached to the inner wall of the left auricle, wherein the supporting framework comprises an anchoring part, a sealing part and an ablation part, and the ablation part is provided with an electrode; the electrodes comprise at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected with two poles of a pulse source; the electrode is capable of transmitting high voltage pulse energy to form an annular ablation zone.
The occlusion ablation device further comprises a connecting tip, wherein the connecting tip is fixedly connected with the proximal end of the sealing part.
The occlusion ablation device of the above, wherein the first electrode and the second electrode are both one of a wire or a metal sheet; or: the first electrode is a metal wire or a metal sheet, and the second electrode is an electrical exposed area of the supporting framework.
The occlusion ablation device as described above, wherein the wire is one of a zigzag shape, a straight shape, and a spring shape.
The occlusion ablation device comprises a support framework, a first electrode and a second electrode, wherein the first electrode and the second electrode are arranged on the periphery of the support framework in a ring shape for one circle, or are arranged on the periphery of the support framework in a semi-ring shape for one half circle, or are arranged on the periphery of the support framework in a local arc shape.
The occlusion ablation device comprises a first electrode, a second electrode, a pulse source and an ablation part, wherein the ablation part further comprises a first conducting wire, one end of the first conducting wire is connected with the first electrode, and the other end of the first conducting wire is used for being connected with one pole of the pulse source; the ablation part also comprises a second conducting wire, one end of the second conducting wire is connected with the second electrode, and the other end of the second conducting wire is used for being connected with the other pole of the pulse source.
The occlusion ablation device as described above, wherein the electrically exposed region is electrically connected to the pulse source via the supporting framework and the connecting tip.
The occlusion ablation device comprises a support framework, a connecting end, a first conducting wire and a second conducting wire, wherein the support framework is arranged on the outer layer of the first conducting wire, the connecting end is arranged on the outer layer of the second conducting wire, and the outer layer of the first conducting wire and the outer layer of the second conducting wire are insulated.
The occlusion ablation device of any of the above claims, wherein the first electrode comprises a plurality of first sub-electrodes and the second electrode comprises a plurality of second sub-electrodes; each first branch electrode is connected with one first conducting wire, and each second branch electrode is connected with one second conducting wire.
The occlusion ablation device comprises a first branch electrode, a second branch electrode, a first conducting wire and a second conducting wire, wherein the first branch electrode and the second branch electrode are respectively connected with the first conducting wire and the second conducting wire; the fixed sheath tube is of a hollow structure and is made of flexible insulating materials.
The occlusion ablation device of the above, wherein the fixed sheath comprises an extension sheath and an annular sheath surrounding at least one turn of the support frame, the annular sheath being fixedly connected to the support frame; one end of the extension sheath tube is fixedly connected with the annular sheath tube; the first branch electrode and the second branch electrode are fixed on the annular sheath, one end of the first conducting wire is fixedly connected with the first branch electrode, and the other end of the first conducting wire penetrates through the annular sheath and extends into the extension sheath; one end of the second conducting wire is fixedly connected with the second branch electrode, and the other end of the second conducting wire penetrates through the annular sheath and extends into the extension sheath.
The occlusion ablation device as described above, wherein the first electrode and the second electrode share one fixed sheath, and the first sub-electrode and the second sub-electrode are fixed at an intersecting interval outside the same annular sheath; or the first electrode and the second electrode respectively use one fixed sheath, the first sub-electrodes are fixed on the outer sides of the corresponding annular sheaths at intervals, and the second sub-electrodes are fixed on the outer sides of the corresponding annular sheaths at intervals.
The occlusion ablation device as described above, wherein when the first electrode and the second electrode share one fixed sheath, the first sub-electrodes and the second sub-electrodes are alternately distributed on the annular sheath at equal intervals; when the first electrode and the second electrode respectively use one fixed sheath, the first sub-electrodes are distributed on the annular sheath used by the first conducting wire at equal intervals, and the second sub-electrodes are distributed on the annular sheath used by the second conducting wire at equal intervals.
The occlusion ablation device comprises a first sub-electrode, a second sub-electrode and a third sub-electrode, wherein the first sub-electrode and the second sub-electrode are both sub-metal sheets; the shape of the metal sub-sheet is any one of L shape, strip shape, round shape or triangle shape.
The occlusion ablation device comprises a support framework, wherein the electrode is arranged on the support framework, and the electrode is arranged on the support framework and can be detachably connected with the support framework.
The occlusion ablation device is characterized in that the supporting framework is a grid-shaped framework made of elastic metal wires through weaving or elastic metal laser cutting and heat setting.
The occlusion ablation device is characterized in that the electrode is made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy or stainless steel.
The plugging ablation device comprises a supporting framework attached to the inner wall of the left auricle, wherein the supporting framework comprises an anchoring part, a sealing part and an ablation part, and the ablation part is provided with an electrode; the electrodes comprise at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected with two poles of a pulse source; the electrode is capable of transmitting high voltage pulse energy to form an annular ablation zone. Wherein sealing is used for carrying out the shutoff with left auricle, and anchoring part is used for fixing whole device in the inside of left auricle, melts the portion and is used for blocking left auricle inner wall electrophysiological signal completely, reaches the purpose of recovering the sinus rate, and sealing carries out the shutoff with left auricle, reaches the purpose of apoplexy prevention. Therefore, the operation instrument can be used for simultaneously performing pulse ablation treatment and left atrial appendage occlusion, the operation instrument can also play roles in sinus rhythm recovery and stroke prevention, and the problems that in the prior art, an operation needs to be separately performed and two instruments need to be used are solved.
Drawings
In order to more clearly illustrate the technical solution 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 only some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
FIG. 1 is an elevation view of an occlusion ablation device provided in accordance with a first embodiment of the invention;
FIG. 2 is an elevation view of an occluding ablation device provided in accordance with a second embodiment of the invention;
FIG. 3 is an elevation view of an occluding ablation device provided by a third embodiment of the invention;
fig. 4 is an elevation view of an occlusion ablation device provided in accordance with a fourth embodiment of the invention;
FIG. 5 is a cross-sectional view A-A of the annular sheath and the second sub-electrode of the occluding ablation device provided by the fourth embodiment of the invention;
FIG. 6 is a schematic view of a connection tip of an occluding ablation device according to a fourth embodiment of the invention;
fig. 7 is a top view, in direction B, of an annular sheath and a second electrode of an occlusion ablation device according to a fourth embodiment of the invention;
fig. 8 is an elevation view of an occlusion ablation device provided in accordance with a fifth embodiment of the invention;
fig. 9 is an elevation view of another occlusion ablation device provided in accordance with a fifth embodiment of the invention;
fig. 10 is a schematic structural diagram of a first electrode and a second electrode of an occlusion ablation device according to a fifth embodiment of the invention.
Description of reference numerals:
10-sealing part, 11-gap section, 12-interference section, 13-current-blocking membrane, 20-anchoring part, 21-barb, 30-ablation part, 31-supporting framework, 32-first electrode, 321-first sub-electrode, 33-second electrode, 331-second sub-electrode, 34-first conducting wire, 35-second conducting wire, 36-fixed sheath, 361-extending sheath, 362-annular sheath, 40-connecting piece, 50-connecting end and 51-jack.
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 derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
In an embodiment of the invention, the end relatively further from the operator is the distal end and the end relatively closer to the operator is the proximal end.
Referring to fig. 1 to 4, an embodiment of the present invention provides an occlusion ablation device, which includes a supporting framework attached to an inner wall of a left atrial appendage, the supporting framework includes a sealing portion 10, an anchoring portion 20 and an ablation portion 30, a distal end of the sealing portion 10 is fixedly connected to a proximal end of the anchoring portion 20, and the occlusion ablation device further includes the ablation portion 30; the ablation part 30 is provided with electrodes, and the electrodes at least comprise a first electrode 32 and a second electrode 33; namely, the first electrode 32 and the second electrode 33 are respectively used for connecting with two poles of a pulse source; the electrodes, i.e., the first electrode 32 and the second electrode 33, are capable of delivering a high voltage pulsed energy source to form an annular ablation region. The electrode is made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy or stainless steel.
The pulse source can generate monophasic pulses or biphasic pulses; one pole of the pulse source is connected with the first electrode 32, and the other pole of the pulse source is connected with the second electrode 33; when energized, the first electrode 32 and the second electrode 33 generate a high voltage pulsed energy source. In actual use, parameters such as voltage, pulse width and the like of the pulse source can be selected so as to adapt to ablation of tissues with different thicknesses.
In actual use, the sealing portion 10 is located at the proximal end of the operator for sealing the entrance of the left atrial appendage, the anchoring portion 20 is located at the distal end of the operator for anchoring the occlusion ablation device in the left atrial appendage, and the ablation portion 30 is used for performing annular ablation on the inner wall near the entrance of the left atrial appendage.
The sealing part 10 is used for blocking and separating the left atrial body and the left atrial appendage so as to prevent thrombus in the left atrial appendage from entering the left atrium, and the anchoring part 20 can firmly fix the whole left atrial appendage plugging and ablation device in the left atrial appendage; also, in any embodiment, the ablating portion 30 is disposed between the sealing portion 10 and the anchoring portion 20 and, in use, is implanted in the body adjacent to or at the entrance of the left atrial appendage; the annular ablation is performed on the inner wall at or near the entrance of the left atrial appendage through the first electrode 32 and the second electrode 33, so that the cure success rate of atrial fibrillation ablation is increased.
In using the occluding ablation device provided by embodiments of the present invention, the sealing portion 10 is located proximally and the anchoring portion 20 is located distally. The blocking and ablating device is conveyed to the position of the left auricle of the heart in a mode of percutaneous puncture of a conveying sheath, wherein the anchoring portion 20 is placed inside the left auricle, the sealing portion 10 is blocked at the entrance of the left auricle or the position close to the entrance of the left auricle, the entrance of the left auricle is sealed, at the moment, the outer surface of the supporting framework 31 is attached or basically attached to the inner wall of the left auricle, and the lesion part needing to be ablated is ensured to be located in the annular ablation area. Then the first electrode 32 and the second electrode 33 are respectively connected with two poles of a pulse source, the pulse source is started, the first electrode 32 and the second electrode 33 carry out annular ablation on the entrance of the left auricle or the position close to the entrance of the left auricle by transmitting high-voltage pulse energy, at the moment, irreversible electroporation is carried out on cells on the inner wall of the entrance of the left auricle or the position close to the entrance of the left auricle, namely, electrophysiological signals on the inner wall of the left auricle are completely blocked, apoptosis is realized, and the effect of ablating the cells by non-thermal effect is achieved.
Therefore, according to the occlusion ablation device provided by the embodiment of the invention, the sealing part 10 is used for occluding the left atrial appendage, the anchoring part 20 is used for fixing the whole device inside the left atrial appendage to completely block electrophysiological signals on the inner wall of the left atrial appendage, so that the sinus rate is recovered, and the sealing part 10 is used for occluding the left atrial appendage to prevent stroke. Therefore, the operation instrument can be used for simultaneously performing pulse ablation treatment and left atrial appendage occlusion, the operation instrument can also play roles in sinus rhythm recovery and stroke prevention, and the problems that in the prior art, an operation needs to be separately performed and two instruments need to be used are solved. Because only one operation instrument is needed, the operation difficulty of an operator is greatly reduced, the risk in the operation is greatly reduced, the operation procedure is simplified, the operation safety factor is increased, the ablation is more thorough, and the treatment effect is better. In the embodiment, the atrial fibrillation is treated by using a pulse ablation method, so that the sinus rhythm of a patient is recovered. Pulse ablation utilizes a high-intensity high-voltage pulse energy source to cause irreversible electrical breakdown of cell membranes, called irreversible electroporation (IRE) in the medical field (i.e., to completely destroy abnormal electrophysiological cell tissues), so that cells are ablated by apoptosis so as to realize non-thermal effect, and thus are not affected by heat sink effect. The high-voltage pulse energy generates less heat, does not need to be washed by normal saline to be cooled, and can effectively reduce the occurrence of air explosion, eschar and thrombus. In addition, the pulse ablation treatment time is short, the treatment time for applying a group of pulse sequences is less than 1 minute, and the whole ablation time is generally not more than 5 minutes. And because different tissues have difference to the response threshold value of the pulse electric field, the possibility is provided for ablating abnormal electrophysiological cells on the cardiac muscle without interfering other adjacent tissues, thereby avoiding injuring the tissues adjacent to the left auricle by mistake. And the electric field lines start from positive charges to negative charges uninterruptedly, and the electrodes can be arranged in a mode that the electric field lines are concentrated in an annular area to carry out annular ablation on the inner wall of the left atrial appendage. In addition, compared with other energy, pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field intensity can be subjected to electroporation, so that the requirement on catheter sticking pressure during ablation is reduced. Therefore, even if the ablation portion 30 does not completely conform to the inner wall of the left atrial appendage after entering the left atrial appendage, the IRE ablation effect is not affected.
Further, the first electrode 32 and the second electrode 33 are made of a biocompatible metal material, and in one embodiment, the first electrode 32 and the second electrode 33 may be made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy, or stainless steel.
Further, the ablation part 30 of the occlusion ablation device provided by the embodiment of the present invention further includes a first conductive wire 34 and a second conductive wire 35. One end of the first conductive line 34 is connected to the first electrode 32, and the other end of the first conductive line 34 is used for connecting to one pole of the pulse source. One end of the second conductive line 35 is connected to the second electrode 33, and the other end of the second conductive line 35 is used to connect to the other pole of the pulse source.
It will be understood by those skilled in the art that the first and second conductive wires 34 and 35 are used to electrically connect the first and second electrodes 32 and 33, respectively, to two poles of a pulse source, so that the pulse source can provide high voltage pulses to the first and second electrodes 32 and 33 to enable a surgeon to perform a surgical operation smoothly.
It will also be appreciated by those skilled in the art that the first and second conductive wires 34, 35 may be wires or cables that are directly or indirectly connected to the poles of the pulse source.
Preferably, the first conductive line 34 and the second conductive line 35 are both subjected to insulation treatment. Specifically, the outer layers of the first conductive wire 34 and the second conductive wire 35 are both coated with a wire insulating layer; or the outer layers of the first conducting wire 34 and the second conducting wire 35 are both sleeved with conducting wire insulating sheath tubes. The wire insulating layer and the wire insulating sheath tube are made of any one of polyester, polyurethane, polyimide, perfluoroethylene-propylene copolymer, ethylene-tetrafluoroethylene copolymer, soluble polytetrafluoroethylene or parylene.
In one embodiment, referring to fig. 1, the first conductive line 34 may extend directly to the outside of the body to connect to one pole of the pulse source; referring to fig. 3, a first conductive wire (not shown) and a second conductive wire (not shown) may be extended directly to the outside of the body to connect with the two poles of the pulse source, and the first conductive wire and the second conductive wire are located in the fixed sheath 36.
In one embodiment, referring to fig. 2, a connection terminal 50 is further included, and the connection terminal 50 is fixedly connected to the proximal end of the sealing portion 10, so that hollow holes may be provided in the supporting frame 31 and the connection terminal 50, and the first conducting wire 34 and the second conducting wire 35 both pass through the hollow holes of the supporting frame 31 and the connection terminal 50, and then extend into the delivery device to be electrically connected to two poles of the pulse source. In addition, the outer side (upper end in fig. 2) of the connection terminal 50 is further provided with an external thread, which can be fixedly connected with the steel cable, so as to realize mechanical connection, and the connection is prevented from loosening, of course, only the second conducting wire is connected with the jack, and the first conducting wire 34 is connected in the manner shown in fig. 1.
Further, the first conductive line 34 and the first electrode 32 may be formed integrally or may be formed by welding. Similarly, the second conductive wire 35 and the second electrode 33 may be integrally formed or welded. Particularly, when the first electrode 32 and the first conductive line 34 are made of the same material, it is preferable that they are integrally formed. When the first electrode 32 and the first conductive line 34 are made of different materials, for example, to reduce the cost, the first electrode 32 is made of platinum and the first conductive line 34 is made of copper, and then the first electrode 32 and the first conductive line 34 may be formed by welding. Of course, it is also possible that the first conductor consists of two parts, a wire inside the fixed sheath 36 and a cable connected to the connection terminal 50, as shown in fig. 4. The second conductive line 35 and the second electrode 33 are the same.
There are various specific implementations of the first electrode 32 and the second electrode 33, and the first electrode 32 and the second electrode 33 are used to transmit the high voltage pulse. The first electrode 32 and the second electrode 33 are both one of metal wires or metal sheets; or the first electrode 32 is a metal wire or a metal sheet, and the second electrode 33 is an electrical exposed region of the support framework.
The first electrode with the second electrode encircles support skeleton periphery round is the annular, perhaps encircles support skeleton periphery half-turn is the semi-annular, perhaps encircles support skeleton periphery part is the arc. For example: the first electrode 32 and the second electrode 33 are each a wire (wire-like shape) that is looped around the support frame 31; or the first electrode 32 and the second electrode 33 are both metal sheets (similar to a belt shape) which encircle the supporting framework 31 by one circle; or the first electrode 32 is a metal wire or a metal sheet which surrounds the supporting framework 31 by one circle, and the second electrode 33 is an electrical exposed area which surrounds the supporting framework 31 by one circle; or the first electrode 32 is a semi-annular metal wire or metal sheet surrounding the support framework 31 for a half-circle, the second electrode 33 is a semi-annular metal wire or metal sheet surrounding the support framework 31 for a half-circle and corresponding to the first electrode 32, and the first electrode 32 and the second electrode 33 are combined into a complete ring; alternatively, the first electrode 32 is an arc-shaped wire or sheet that encircles a quarter turn of the support frame 31, and the second electrode 33 is an arc-shaped wire or sheet that encircles a three quarter turn of the support frame 31, which form a complete ring.
In another embodiment, referring to fig. 2, the first electrode 32 and the second electrode 33 are both wires that are wound around the supporting frame 31. The wires are fixed to the supporting frame 31 by binding or sewing.
In this embodiment, the wire may also be provided with a zigzag shape, which is advantageous in that it is easily compressed, i.e., when the support frame 31 is retracted into the delivery sheath, the zigzag wire may be folded and bent to be retracted into the delivery sheath. In addition, during ablation, a high-voltage pulse source generated by the electrode with the shape is more concentrated between the first electrode and the second electrode, so that the ablation directionality is stronger and more uniform, and the muscle stimulation is smaller. Of course, the wire may be in any shape of a straight line or a spring. Because the metal wire is made of a flexible material, a person skilled in the art can fold the metal wire into any suitable shape, which all belong to the protection scope of the present application and are not described herein again.
In another embodiment, referring to fig. 1, the first electrode 32 is a ring-shaped metal wire that surrounds the supporting frame 31 by one turn, and the second electrode 33 is a ring-shaped electrically exposed region that surrounds the supporting frame 31 by one turn. The looped wire is also secured to the support frame 31 by means of binding or stitching.
The second electrode 33, i.e., the annular electrically exposed region, is electrically connected to the second conductive line 35 through the supporting frame 31 and the connecting terminal 50.
In the occlusion ablation device provided by the embodiment of the invention, at least the ablation part 30 is subjected to insulation treatment, specifically, in the embodiment, an insulation part is arranged outside the ablation part 30 to prevent the non-insulation part from interfering with an electric field, so that the treatment effect is not affected. More preferably, the whole occlusion ablation device except the first electrode 32 and the second electrode 33 is insulated, including but not limited to the sealing part 10, the anchoring part 20, the ablation part 30, etc. The annular electrically exposed region is actually formed by peeling off a circle of insulating part on the supporting framework 31, so that the circle of conductive metal of the supporting framework 31 is exposed to serve as the second electrode 33, and since the supporting framework 31 and the connecting terminal 50 are made of conductive materials, the second conductive wire 35 is directly connected with the supporting framework 31, so that the second electrode 33 can be ensured to be electrified. It is understood that when the second electrode 33 is an annular electrically exposed region surrounding the supporting frame 31, the second conductive wire 35 is directly screwed to the connecting terminal 50 without passing through the sealing portion 10, the supporting frame 31, and the like. The blocking ablation device can be electrically connected with the pulse energy source and can also be mechanically connected with the pulse energy source.
Preferably, when treatment is complete, the first and second electrodes 32, 33 are withdrawn from the patient in order to avoid leaving the electrodes in the patient's body to affect the patient. At this time, part or all of the electrode is detachably connected to the support frame 31, and the detachably connected part can be withdrawn from the body by an external force. Referring to fig. 1, the first electrode 34 may be withdrawn from the body, and specifically, the first electrode 34 may be separated from the supporting framework 31 by an external force.
In yet another embodiment, referring to fig. 3 and fig. 4, the first electrode 32 includes a plurality of first sub-electrodes 321, and the second electrode 33 includes a plurality of second sub-electrodes 331; the first sub-electrode 321 and the second sub-electrode 331 are both connected with the supporting framework 31 through the fixed sheath 36; each of the first sub-electrodes 321 is connected to a first conductive line (not shown), and each of the second sub-electrodes 331 is connected to a second conductive line (not shown). The fixed sheath 36 is a hollow structure and is made of a flexible insulating material, such as plastic.
Further, with continued reference to fig. 3 and 4, the fixed sheath 36 includes an extending sheath 361 and an annular sheath 362 surrounding the supporting frame 31, the annular sheath 362 being fixedly connected to the supporting frame 31; one end of the extension sheath 361 is fixedly connected to the annular sheath 362. The first sub-electrode 321 and the second sub-electrode 331 are both fixed on the annular sheath 362, one end of the first conducting wire is fixedly connected with the first sub-electrode 321, and the other end of the first conducting wire passes through the annular sheath 362 and extends into the extension sheath 361. One end of the second conductive wire is fixedly connected to the second sub-electrode 331, and the other end of the second conductive wire passes through the annular sheath 362 and extends into the extension sheath 361. In fig. 3 and 4, the first conductive wire and the second conductive wire are located in the fixed sheath 36, not shown in the drawings.
Preferably, the first sub-electrode 321 and the second sub-electrode 331 may be fixed to the annular sheath 362 by means of bonding or the like. The cross section of the annular sheath 362 is preferably rectangular, and the annular sheath 362 with the rectangular cross section can be used for preventing the annular sheath 362 from being overturned, so that the influence of the device on a patient is reduced.
In one embodiment, referring to fig. 3, the first electrode 32 and the second electrode 33 share a fixed sheath 36, and the first sub-electrode 321 and the second sub-electrode 331 are fixed at intervals on the outer side of the same annular sheath 362. Preferably, when the first electrode 32 and the second electrode 33 share one fixed sheath 36, the first sub-electrodes 321 and the second sub-electrodes 331 are alternately distributed on the annular sheath 362 at equal intervals. The equidistant distribution has the advantage of making the electric field distribution more uniform.
In another preferred embodiment, referring to fig. 4, the first electrode 32 and the second electrode 33 each use a fixed sheath 36, the first sub-electrodes 321 are fixed at intervals outside the corresponding annular sheath 362, and the second sub-electrodes 331 are fixed at intervals outside the corresponding annular sheath 362. Preferably, when one fixed sheath 36 is used for each of the first electrode 32 and the second electrode 33, the first sub-electrodes 321 are equally spaced on the annular sheath 362, and the second sub-electrodes 331 are equally spaced on the annular sheath 362. Also, the advantage of equal spacing is that the electric field distribution is made more uniform.
Preferably, the first sub-electrode 321 and the second sub-electrode 331 are both metal sheets, and the shape of the metal sheets is L-shaped, strip-shaped, circular or triangular. Referring to fig. 5, the cross section of the metal sheet is L-shaped. Particularly, when the first electrode 32 and the second electrode 33 respectively use one fixed sheath 36, the first sub-electrode 321 is fixed at intervals on the outer side of the corresponding annular sheath 362, and the second sub-electrode 331 is fixed at intervals on the outer side of the corresponding annular sheath 362, at this time, the L-shaped sub-metal sheet is adopted, so that the electric field intensity of the auricle wall region between the first electrode 32 and the second electrode 33 can be increased, the electric field is more uniformly distributed on the inner wall of the left auricle, the electric field intensity distributed on the inner wall of the left auricle is higher, and the annular ablation is more permeable to the wall.
Referring to fig. 4, a hollow hole may be formed on the supporting frame 31, and a plug 51 (refer to fig. 6) may be formed on the connecting end 50, where the plug 51 is located at an end of the connecting end 50 facing the conveying sheath, with reference to the direction of fig. 4. The number of the insertion holes 51 is the same as the sum of the number of the first conductive wires and the second conductive wires, the first conductive wires (not shown) and the second conductive wires (not shown) can pass through the hollow holes on the supporting frame 31 and then are fixedly connected with the insertion holes 51 in a one-to-one correspondence manner, and the first conductive wires and the second conductive wires are located in the fixed sheath 36. In addition, the outer side (upper end in fig. 4) of the connection end 50 is provided with an external thread, which can be fixedly connected with the steel cable, so as to realize mechanical connection and prevent the connection from loosening. Then the steel cable is equipped with the plug-in pin, and the number of plug-in pin is the same with the quantity sum of first conducting wire and second conducting wire, and the steel cable is preferred to adopt platinum or copper to make the two poles of the earth that can connect the pulse source, realizes the electrical connection. At this time, the seeker of one pole and the seeker of the other pole of the pulse source are correspondingly provided with a plurality of leads, and the number of the leads corresponds to the number of the first conducting wires and the second conducting wires, so that the electric field of each sub-pole can be independently controlled.
Compared with the mode that the first conducting wire 34 directly extends in the figure 1, the hollow hole is used for penetrating, the volume of the whole device can be reduced, and the injury degree to the patient is reduced. The first conductive wire and the second conductive wire are preferably made of platinum or copper, but the first conductive wire and the second conductive wire may also be made of other conductive metals, and the invention is not limited herein.
Furthermore, the electrode can be connected with a multi-lead recorder and can also collect intracardiac electric signals to detect whether the electrophysiological signals on the inner wall of the left auricle are completely blocked, thereby ensuring that the treatment can eliminate arrhythmia and restore sinus rhythm.
Similar to the manner in which the wire is used, the first and second electrodes 32, 33 may also be withdrawn from the patient after the treatment is completed, using the first and second sub-electrodes 321, 331. Since the first and second sub-electrodes 321 and 331 are connected to the supporting frame 31 via the annular sheath 362, the first and second electrodes 32 and 33 are simultaneously removed from the body by simply removing the annular sheath 362 from the body. In fig. 3, an external force may be applied to the extension sheath 361, and the extension sheath 361 drives the annular sheath 362 to separate from the supporting framework 31, so as to bring the first electrode and the second electrode out of the body, thereby preventing the electrodes from remaining in the body and affecting the body of the patient.
Further, the sealing part 10, the anchoring part 20 and the supporting framework 31 of the occlusion ablation device provided by the embodiment of the invention are all mesh-shaped circular rings made of metal wire weaving or metal wire laser cutting heat setting. The braided metal wire of the present embodiment may be nickel-titanium alloy, cobalt-chromium alloy, stainless steel, or other metal material with good biocompatibility. Superelastic shape memory alloy nickel titanium wires are preferred.
Wherein, the ablation part 30, the sealing part 10 and the anchoring part 20 can be integrally formed (fig. 3 and 8), and the ablation part 30 is located between the sealing part 10 and the anchoring part 20. It is understood that the ablation portion 30 is at least the location between the sealing portion 10 and the anchoring portion 20 where the first electrode 32 and/or the second electrode 33 can be secured or act.
The sealing portion 10 and the anchoring portion 20 may be formed separately (fig. 1, 2, and 4), and specifically, the sealing portion 10 and the anchoring portion 20 may be fixedly connected by a connecting member 40. In this case, the ablation portion 30 may be integrally formed with the sealing portion 10 (fig. 4), or the ablation portion 30 may be integrally formed with the anchoring portion 20 (fig. 1, 2, 4, 9), or a part of the ablation portion 30 may be integrally formed with the sealing portion 10 and the remaining part may be integrally formed with the anchoring portion 20 (fig. 4). It should be understood that the ablation portion 30 herein refers to a supporting skeleton of the ablation portion 30.
Preferably, the connection member 40 is fixedly connected to the sealing part 10 and the anchoring part 20 by welding, respectively, and the connection member 40 has a metal cylindrical shape. The connecting piece 40 is arranged to adjust the overall length of the occlusion ablation device, so that multiple occlusion ablation devices of different models can be manufactured at the lowest cost, and the applicability is improved.
In the occlusion ablation device provided by the embodiment of the present invention, at least the ablation part 30 is subjected to insulation treatment, specifically, in the embodiment, an insulation component is disposed outside the ablation part 30 to prevent other parts from being electrically connected with the ablation part, so that the treatment effect is not affected. More preferably, the whole occlusion ablation device except the first electrode 32 and the second electrode 33 is insulated, including but not limited to the sealing part 10, the anchoring part 20, the ablation part 30, etc.
As mentioned above, the whole device is insulated at least at the ablation portion 30, and preferably, the sealing portion 10, the anchoring portion 20, the connecting member 40 and the connecting tip 50 are insulated on the outer side. That is, the whole supporting framework 31 is insulated to prevent the other parts from being electrically conducted with the ablation part to affect the treatment effect.
The insulation treatment is an insulation type coating coated on the outer surface of the corresponding part or an insulation type sleeve sleeved on the outer surface of the corresponding part. Specifically, the insulating coating and the insulating sleeve are made of any one of polyester, polyurethane, polyimide, perfluoroethylene-propylene copolymer, ethylene-tetrafluoroethylene copolymer, soluble polytetrafluoroethylene or parylene.
It will be appreciated that when the connector 40 is provided, a hollow bore is provided in the connector 40 in order to facilitate connection of the first and second conductors 34, 35 to the two poles of the pulse source.
Further, a circle of barbs 21 is arranged on the anchoring portion 20 along the circumferential direction, one end of each barb 21 is fixedly connected with the outer side of the anchoring portion 20, and the other end extends obliquely towards the direction of the sealing portion 10. The barbs 21 are primarily used to secure the entire device in the left atrial appendage, increasing the stability of the entire device during operation.
Further, at least one layer of flow-blocking film is fixedly connected to the inner side or the outer side of the sealing part 10, the ablation part 30 and the anchoring part 20. The flow blocking film is mainly used for realizing the sealing function of the occlusion ablation device so as to better occlude the entrance of the left auricle. Preferably, the flow-blocking film is made of polyethylene terephthalate (PET) or Polytetrafluoroethylene (PTFE). The flow-blocking membrane is preferably sutured into the interior of the sealing portion 10, the ablating portion 30 and the anchoring portion 20.
To increase the sealing effect, the sealing portion 10 preferably comprises a gap section 11 and an interference section 12 (fig. 4) fixedly connected at the ends, the diameter of the interference section 12 being larger than the diameter of the gap section 11, the interference section 12 being located at the end remote from the anchoring portion 20. It will be appreciated by those skilled in the art that the outer sides of the sealing portion 10, the ablating portion 30 and the anchoring portion 20, after complete release, should conform to the left atrial appendage. Slightly bigger with the interference section 12 diameter setting of sealing portion 10, can increase the laminating degree of inseparability of left auricle and this interference section 12 to better seal the left auricle.
Several more specific embodiments are listed below to facilitate understanding by those skilled in the art:
the first embodiment:
as shown in fig. 1, the embodiment of the present invention provides an occlusion ablation device, which is a supporting framework 31 woven by nitinol wires and attached to the inner wall of the left atrial appendage. The support framework 31 comprises a connecting end 50, a sealing part 10, a connecting part 40 and an anchoring part 20 which are fixedly connected in sequence from the proximal end to the distal end, and the ablation part 30 and the proximal end of the anchoring part 20 are integrally formed. The ablation part 30 is provided with electrodes, and the electrodes comprise a first electrode 32 and a second electrode 33; the whole supporting framework 31 is completely coated with parylene insulation treatment, and a circle of insulating material is stripped at the anchoring part to leave a circle of annular electrical exposed area. The first electrode 32 is a looped wire that loops around the ablation portion 30, and the second electrode 33 is a looped electrically exposed region that loops around the ablation portion 30 such that the electric field created by the two electrodes concentrates the electric field strength in the region between the two loops. In order to increase the sealing effect, the sealing part 10 is a nickel-titanium metal wire braided disc with a diameter larger than that of the anchoring part 20, and a layer of flow-blocking film is sewn in the braided disc and used for blocking the orifice of the left auricle.
The first electrode 32 is electrically connected to a pulse source outside the body via a first conductive wire 34. One end of the first conducting wire 34 is fixedly connected with the first electrode 32, and the other end is in a free extension state, and when the external pulse generator is used, the other end of the first conducting wire 34 can be directly extended to one pole of the external pulse source to be connected.
The second electrode 33 is electrically connected to an external pulse source through a wire cable for delivery. Specifically, the steel cable is made of any one of platinum, platinum-iridium alloy, gold, nickel-titanium alloy or stainless steel, and is electrically and mechanically connected to the connection terminal 50 in a threaded connection manner, so that the second electrode 33 is finally electrically connected to the pulse source through the support frame 31, the connection member 40, the connection terminal 50 and the steel cable.
The first electrode 32 and the second electrode 33 act as both positive and negative poles of the pulsed electric field such that the electric field is concentrated in the region between the two electrodes to form a ring-shaped ablation zone.
The following details the mode of use: during operation, the connecting end 50 on the sealing part 10 is connected with a conveying lead such as a steel cable in a threaded mode, the whole plugging and ablating device is put into a conveying sheath tube with a smaller diameter, then enters the inferior vena cava through femoral vein puncture, then enters the right atrium, and then enters the left atrium through interatrial puncture. When the left auricle occlusion ablation device is released, the anchoring part 20 is released inside the left auricle after the release, and the barb 21 is hooked into the inner wall of the left auricle; the first electrode 32 and the second electrode 33 of the ablation part 30 are closely attached to the inner wall of the left auricle near the entrance, and the flow blocking film in the sealing part 10 blocks the mouth of the left auricle to prevent blood from entering the left auricle and thrombus in the left auricle from flowing into the left atrium.
After the left auricle plugging ablation device is released in the left auricle, the other end of the first conducting wire 34 is connected with one pole of the pulse source, the steel cable is connected with the other pole of the pulse source, and the high-voltage pulse energy is transmitted to the inner wall of the left auricle, so that irreversible electroporation is carried out on the cell at the inlet of the left auricle or the inner wall close to the inlet of the left auricle, apoptosis is realized, and the therapeutic effect of the ablation cell with non-thermal effect is achieved.
After the ablation operation is finished, the first conducting wire 34 is withdrawn, the first electrode 32 is driven, namely the first ring of annular metal wires are withdrawn together to form the supporting framework, the steel cable and the left auricle plugging ablation device are released, the supporting framework of the left auricle plugging ablation device is left in the left auricle to realize long-term plugging performance, and meanwhile, the influence on the body of a patient caused by the electrode remaining in the body of the patient is avoided.
The plugging ablation device provided by the embodiment can realize plugging of the left auricle in one operation by utilizing the self structure of the plugging ablation device, and realize complete ablation and blocking of the oral part of the left auricle, thereby increasing the ablation success rate of atrial fibrillation.
It will be understood by those skilled in the art that the sealing portion 10, the anchoring portion 20 and the ablating portion 30 may be integrally formed or connected by a connecting member 40 or the like in this first embodiment.
Second embodiment:
as shown in fig. 2, an embodiment of the present invention provides an occlusion ablation device, which is a supporting framework 31 woven from nickel-titanium metal wires, wherein the whole supporting framework is completely coated with parylene insulation treatment and is attached to the inner wall of the left atrial appendage. The difference from the first embodiment is that the first electrode 32 and the second electrode 33 are both annular zigzag wires which encircle the ablation part 30, and the connecting tip 50 has a hollow structure. Hollow holes are formed in the anchoring portion 20, the ablation portion 30, the connecting piece 40 and the sealing portion 10, and the first conducting wire 34 and the second conducting wire 35 penetrate through the hollow holes of the supporting framework 31 and the connecting end 50 and then extend into the delivery device to be electrically connected with the two poles of the pulse source. In addition, the outer side (the upper end in fig. 2) of the connecting end head is also provided with an external thread which can be fixedly connected with the steel cable, so that the mechanical connection is realized, and the connection part is prevented from loosening.
More specifically, the entire device is insulated except for the first electrode 32 and the second electrode 33. And barbs 21 are provided on the anchoring portion 20.
The first electrode 32 and the second electrode 33 are connected to the supporting framework through medical glue as the positive pole and the negative pole of a pulse electric field, so that the electric field is concentrated in the area between the two electrodes to form an annular ablation area. Because the annular metal wire is in a sawtooth shape in the embodiment, the sawtooth-shaped annular metal wire enables an electric field to be denser, the strength to be increased, and the ablation efficiency to be improved.
In use, the first and second conductive lines 34, 35 extend to connect with respective poles of the pulse source. Its specific use mode, with first embodiment, no longer describe herein, the difference lies in after melting the end, can withdraw first conducting wire 34 and second conducting wire 35 through external force and separate first electrode 32 and second electrode 33 and support skeleton, withdraw from the internal body to with conveyor and left atrial appendage shutoff ablation device release, thereby make left atrial appendage shutoff ablation device's support skeleton stay and realize long-term shutoff performance in the left atrial appendage, avoid the electrode to stay and cause the influence to the patient's health in the patient body simultaneously.
The third embodiment:
as shown in fig. 3, the embodiment of the present invention provides an occlusion ablation device, which is a supporting framework 31 woven by nitinol wires and attached to the inner wall of the left atrial appendage. The support framework 31 comprises a connecting end 50, a sealing part 10 and an anchoring part 20 which are fixedly connected in sequence from the proximal end to the distal end, and the ablation part 30 and the proximal end of the anchoring part 20 are integrally formed. The anchoring part 20, the ablation part 30 and the sealing part 10 are integrally formed, and in order to increase the sealing effect, at least one layer of flow blocking film is sewn inside or outside the sealing part 10 for blocking the orifice of the left auricle.
A fixed sheath 36 is arranged on the ablation part 30, and a first electrode and a second electrode are fixed on the fixed sheath 36; the part of the supporting framework 31 contacting with the fixed sheath 36 is coated with parylene insulation treatment to prevent the energy loss of the electrode on the fixed sheath 36.
The first electrode 32 includes a plurality of first sub-electrodes 321, and the second electrode 33 includes a plurality of second sub-electrodes 331; the first sub-electrode 321 and the second sub-electrode 331 are both connected with the ablation part 30 through the fixed sheath 36; a first conductive line 34 is connected to each first sub-electrode 321, and a second conductive line 35 is connected to each second sub-electrode 331.
The fixed sheath 36 includes an extension sheath 361 and a ring-shaped sheath 362 surrounding the ablation part 30, the ring-shaped sheath 362 is fixedly connected with the ablation part 30; one end of the extension sheath 361 is fixedly connected to the annular sheath 362.
The first sub-electrode 321 and the second sub-electrode 331 are both metal rings sleeved on the outer surface of the annular sheath 362, and the part of the annular sheath 362 contacting with the metal rings is provided with small holes for the first conducting wire 34 and the second conducting wire 35 to pass through. One end of the first conductive wire 34 is fixedly connected to the first sub-electrode 321, and the other end of the first conductive wire 34 passes through the annular sheath 362 and extends into the extension sheath 361. One end of the second conductive wire 35 is fixedly connected to the second sub-electrode 331, and the other end of the second conductive wire 35 passes through the annular sheath 362 and extends into the extension sheath 361. The first conductive wire 34 and the second conductive wire 35 extend from the extension sheath 361 to be connected to both poles of the pulse source. The first electrode 32 and the second electrode 33 share one fixed sheath 36, and the first sub-electrode 321 and the second sub-electrode 331 are fixed to the outside of the same annular sheath 362 at an intersecting interval. Preferably, the first sub-electrodes 321 and the second sub-electrodes 331 are alternately arranged on the annular sheath 362 at equal intervals. The equidistant distribution has the advantage of making the electric field distribution more uniform.
The basic mode of the application is the same as that of the first embodiment, the leads of the first sub-electrodes 321 and the second sub-electrodes 331 are respectively connected with two poles of the pulse source, when the pulse source outputs energy, an electric field is formed between each first sub-electrode 321 and two adjacent second sub-electrodes 331, so that a plurality of dense small electric fields can be formed between the first electrodes 32 and the second electrodes 33, and a plurality of small electric fields formed between every two adjacent sub-electrodes surround a circle to perform annular ablation treatment on the inner wall of the left atrial appendage, so that the efficiency of the ablation treatment is improved.
After the treatment is completed, please refer to fig. 3, an external force may be applied to the extension sheath 361, and the extension sheath 361 drives the annular sheath 362 to separate from the supporting framework 31, so as to bring the first electrode and the second electrode out of the body, and leave the supporting framework of the left atrial appendage occlusion ablation device in the left atrial appendage to realize the long-term occlusion performance, and simultaneously avoid the influence on the body of the patient caused by the electrode remaining in the body.
In addition, the first electrode 32 and the second electrode 33 adopting the mode can also use a multi-lead recorder to collect intracardiac electric signals before and after ablation, so that the pulse is output in an absolute refractory period, the heart rate is not interfered, and sudden arrhythmia is reduced. After ablation is finished, a multi-lead recorder is used for collecting intracardiac electric signals so as to detect whether the inner wall of the left atrial appendage is completely damaged by electrophysiological cell tissues, thereby ensuring that treatment can eliminate arrhythmia and restore sinus rhythm.
The fourth embodiment:
as shown in fig. 4, the embodiment of the present invention provides an occlusion ablation device, in which a supporting framework 31 woven from nitinol wires is attached to the inner wall of the left atrial appendage. The support frame 31 includes, from the proximal end to the distal end, a connection tip 50, a sealing portion 10, a connection member 40, and an anchoring portion 20, which are fixedly connected in this order. A portion of the ablation portion 30 is integrally formed with the sealing portion 10, and the remaining portion is integrally formed with the anchor portion 20. To increase the sealing effect, the sealing portion 10 is a braided disc of nitinol wire with a diameter larger than that of the anchoring portion 20, and a layer of flow-blocking membrane is sewn into the braided disc for blocking the ostium of the left atrial appendage (not shown).
The supporting framework 31 of the embodiment of the present invention is different from the first embodiment in that the sealing portion 10 further includes a gap section 11 and an interference section 12, the end portions of the gap section 11 and the interference section 12 are fixedly connected, the diameter of the interference section 12 is larger than that of the gap section 11, and the interference section 12 is located at one end far away from the anchoring portion 20. Slightly bigger with the interference section 12 diameter setting of sealing portion 10, can increase the laminating degree of inseparability of left auricle and this interference section 12 to better seal the left auricle.
The ablation part 30 of the embodiment of the present invention is different from the third embodiment in that two fixing sheaths 36 are disposed on the ablation part 30, and the first electrode 32 and the second electrode 33 are fixed respectively. The first electrode 32 includes a plurality of first sub-electrodes 321, and the second electrode 33 includes a plurality of second sub-electrodes 331; the first sub-electrode 321 and the second sub-electrode 331 are both connected with the ablation part 30 through the fixed sheath 36; a first conductive line 34 is connected to each first sub-electrode 321, and a second conductive line 35 is connected to each second sub-electrode 331.
The fixed sheath 36 includes an extension sheath 361 and a ring-shaped sheath 362 surrounding the ablation part 30, the ring-shaped sheath 362 is fixedly connected with the ablation part 30; one end of the extension sheath 361 is fixedly connected to the annular sheath 362. The first sub-electrode 321 and the second sub-electrode 331 are both fixed on the annular sheath 362, one end of the first conducting wire 34 is fixedly connected with the first sub-electrode 321, and the other end of the first conducting wire 34 passes through the annular sheath 362 and extends into the extension sheath 361. One end of the second conductive wire 35 is fixedly connected to the second sub-electrode 331, and the other end of the second conductive wire 35 passes through the annular sheath 362 and extends into the extension sheath 361.
The first electrode 32 and the second electrode 33 are each fixed to the outside of the corresponding annular sheath 362 by using one fixed sheath 36, the first sub-electrode 321 is fixed to the outside of the corresponding annular sheath 362 at an interval, and the second sub-electrode 331 is fixed to the outside of the corresponding annular sheath 362 at an interval, as shown in fig. 7. The first sub-electrodes 321 are equally spaced apart from each other on the annular sheath 362 of the first conductive line 34, and the second sub-electrodes 331 are equally spaced apart from each other on the annular sheath 362 of the second conductive line 35.
The first sub-electrode 321 and the second sub-electrode 331 are both in the form of electrode plates, and the cross section of the electrode plates is L-shaped, as shown in fig. 5, the metal sheet is rectangular, the long side of the metal sheet is fixed on the fixed sheath 36, and the short side of the metal sheet faces outwards. The electrode slice of L shape can increase the regional electric field intensity of auricle wall between first electrode 32 and second electrode 33 for electric field more even distribution is on the inner wall of left auricle, and the electric field intensity of distribution on the inner wall of left auricle is bigger, and the annular melts and changes the transmural more.
The supporting framework 31 is different from the first embodiment in that hollow holes are provided on the anchoring portion 20, the ablation portion 30, the connecting member 40 and the sealing portion 10, specifically: a hollow hole may be provided in the support frame 31, and as shown in fig. 6, a receptacle 51 may be provided in the connection tip, the receptacle 51 being located at an end of the connection tip 50 facing the delivery sheath, with reference to the orientation in fig. 4. The number of the insertion holes 51 is the same as the sum of the number of the first conductive wires and the second conductive wires, the first conductive wires (not shown) and the second conductive wires (not shown) can pass through the hollow holes on the supporting frame 31 and then are fixedly connected with the insertion holes 51 in a one-to-one correspondence manner, and the first conductive wires and the second conductive wires are located in the fixed sheath 36. In addition, the outer side (upper end in fig. 4) of the connection end 50 is provided with an external thread, which can be fixedly connected with the steel cable, so as to realize mechanical connection and prevent the connection from loosening. Then the steel cable head is equipped with the insertion contact pin, and the number of contact pin is the same with the quantity sum of first conducting wire and second conducting wire, and the steel cable is preferred to adopt platinum or copper to make the two poles of the earth that can connect the pulse source, realizes electric connection. At the moment, a plurality of guide heads of one pole and the other pole of the pulse source are correspondingly arranged, and the number of the guide heads corresponds to that of the first conducting wires and the second conducting wires, so that the electric field of each sub-electrode can be independently controlled, and the purpose of ablating a designated area can be achieved.
It has been described above that in the fourth embodiment, the first electrode 32 and the second electrode 33 each use one fixed sheath 36. However, according to actual needs, the implementation manner of the fourth embodiment may be various, and some of them are briefly described as follows:
in one embodiment, the first sub-electrodes 321 are each connected to one pole of the pulse source and the second sub-electrodes 331 are each connected to the other pole of the pulse source, at which time ablation is performed on the region between the first electrode 32 and the second electrode 33 in the left atrial appendage. It will be appreciated that the ablating portion 30 is fixedly attached to the distal end of the sealing portion 10 and the proximal end of the anchoring portion 20.
In another embodiment, a portion of the first sub-electrodes 321 is connected to one pole of the pulse source, the rest of the first sub-electrodes 321 are vacant, a portion of the second sub-electrodes 331 is connected to the other pole of the pulse source, and the rest of the second sub-electrodes 331 are vacant, so that tissue in a specific region can be ablated. It will be appreciated that the ablating portion 30 is fixedly attached to the distal end of the sealing portion 10 and the proximal end of the anchoring portion 20.
In yet another embodiment, the first sub-electrode 321 is divided into two groups, one group being connected to one pole of the pulse source and the other group being connected to the other pole of the pulse source, wherein ablation is performed only on the area of the left atrial appendage near the seal 10. And preferably any two adjacent first sub-electrodes 321 are connected to different poles of the pulse source. It is understood that the ablation portion 30 is fixedly attached to the distal end of the sealing portion 10.
In yet another embodiment, the second sub-electrode 331 is divided into two groups, one group being connected to one pole of the pulse source and the other group being connected to the other pole of the pulse source, wherein ablation is performed only on the region of the left atrial appendage near the anchor 20. And preferably any two adjacent second sub-electrodes 331 are connected to different poles of the pulse source. It will be appreciated that the ablation portion 30 is fixedly attached to the proximal end of the anchor portion 20.
More preferably, before ablation, the electrodes can also be connected with an electrocardiograph synchronizer, and the electrocardiograph synchronizer is used for collecting intracardiac electric signals, so that the pulse output is in an absolute refractory period, the heart rate is not interfered, and sudden arrhythmia is reduced. After ablation is finished, intracardiac electric signals are collected to detect whether the inner wall of the left atrial appendage is completely damaged by electrophysiological cell tissues, so that treatment is ensured to eliminate arrhythmia and restore sinus rhythm.
Fifth embodiment:
as shown in fig. 8, an embodiment of the invention provides an occlusion ablation device, in which an open supporting framework 31 formed by cutting a nickel-titanium metal tube integrally with a laser is attached to the inner wall of a left atrial appendage. The support frame 31 includes, from the proximal end to the distal end, a connection tip 50, a sealing portion 10, and an anchoring portion 20 fixedly connected in this order. The ablation portion 30 is integrally formed with the anchor portion 20, which has an open configuration at its distal end. In order to increase the sealing effect, at least one layer of flow-blocking film 13 is sewn inside or outside the framework of the sealing part 10 for blocking the orifice of the left atrial appendage.
The ablation part 30 is provided with electrodes, and the electrodes comprise a first electrode 32 and a second electrode 33; the connection mode of the electrode and the supporting framework is the same as the fixing mode of the metal wire in the first and second embodiments, and the description is omitted here. The portion of the supporting frame 31 contacting the electrode is coated with parylene insulation to prevent the energy loss due to the electrical connection between the electrode and the metal frame. As shown in fig. 10, the first electrode 32 and the second electrode 33 are made of semi-circular platinum wire which surrounds the ablation portion 30 by a half-circle and form a circle. The first electrode 32 and the second electrode 33 are connected to the positive and negative poles, respectively, of a pulsed electric field such that current flows from one of the electrodes to the other electrode through a radially outer path, thereby forming an annular ablation region. The two are combined to form a complete circle but insulated from each other. The electrode form has the advantages that the electric field is more outwards diffused, so that the electric field is easier to penetrate through the inner wall of the left atrial appendage, and the treatment is more thorough.
In this embodiment, as shown in fig. 9, the metal cutting skeleton is a sealing part 10, the ablation part 30 is integrated with the anchoring part 20, two pieces of metal wires fixed on the outer surface of the supporting skeleton 31 are disposed on the ablation part 30, that is, a first electrode 32 and a second electrode 33, as shown in fig. 10, the first electrode 32 and the second electrode 33 are in a semi-annular shape, and of course, the first electrode 32 and the second electrode 33 in this embodiment may also be in any arc shape, and both may be arranged in a circle-symmetric manner. The first electrode 32 and the second electrode 33 are connected to the positive and negative poles, respectively, of a pulsed electric field such that current flows from one of the electrodes to the other electrode through a radially outer path, thereby forming an annular ablation region.
The above embodiments of the present invention are described in detail, and the principle and the embodiments of the present invention are explained by applying specific embodiments, and the above embodiments are only used to help understanding the method of the present invention and the core idea thereof, and the modifications and the combinations of the various embodiments are within the scope of the present invention; meanwhile, for a person skilled in the art, according to the idea of the present invention, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present invention.

Claims (17)

1. An occlusion ablation device comprising a support frame that conforms to an inner wall of the left atrial appendage;
the supporting framework comprises an anchoring part, a sealing part and an ablation part, and the ablation part is provided with an electrode;
the electrodes comprise at least one first electrode and one second electrode; the first electrode and the second electrode are respectively connected with two poles of a pulse source;
the electrode is capable of transmitting high voltage pulse energy to form an annular ablation zone.
2. The occlusion ablation device of claim 1, further comprising a connection tip fixedly connected to the proximal end of the sealing portion.
3. The occlusion ablation device of claim 2, wherein the first and second electrodes are each one of a wire or a metal sheet; or:
the first electrode is a metal wire or a metal sheet, and the second electrode is an electrical exposed area of the supporting framework.
4. The occlusion ablation device of claim 3, wherein the wire is any one of serrated, straight, or spring-like.
5. The occlusion ablation device of claim 1, wherein the first and second electrodes are annular in shape around the outer circumference of the support frame, semi-annular in shape around the outer circumference of the support frame, or partially arcuate around the outer circumference of the support frame.
6. The occlusion ablation device of claim 1, wherein the ablation portion further comprises a first conductive wire having one end connected to the first electrode and another end for connection to a pole of the pulse source;
the ablation part also comprises a second conducting wire, one end of the second conducting wire is connected with the second electrode, and the other end of the second conducting wire is used for being connected with the other pole of the pulse source.
7. The occlusion ablation device of claim 3, wherein the electrically exposed region is electrically connected to a pulse source via the support frame and a connection tip.
8. The occlusion ablation device of claim 6, wherein the outer layers of the support framework, the connection tip, the first conductive wire and the second conductive wire are insulated.
9. The occlusion ablation device of claim 6, wherein the first electrode comprises a plurality of first sub-electrodes and the second electrode comprises a plurality of second sub-electrodes;
each first branch electrode is connected with one first conducting wire, and each second branch electrode is connected with one second conducting wire.
10. The occlusion ablation device of claim 9, wherein the first and second sub-electrodes and the first and second conductive wires connected thereto are fixed to a fixed sheath; the fixed sheath tube is of a hollow structure and is made of flexible insulating materials.
11. The occlusion ablation device of claim 9, wherein the retaining sheath comprises an extension sheath and an annular sheath surrounding at least one turn of the support frame, the annular sheath being fixedly coupled to the support frame; one end of the extension sheath tube is fixedly connected with the annular sheath tube;
the first branch electrode and the second branch electrode are fixed on the annular sheath, one end of the first conducting wire is fixedly connected with the first branch electrode, and the other end of the first conducting wire penetrates through the annular sheath and extends into the extension sheath;
one end of the second conducting wire is fixedly connected with the second branch electrode, and the other end of the second conducting wire penetrates through the annular sheath and extends into the extension sheath.
12. The occlusion ablation device of claim 11, wherein the first electrode and the second electrode share one of the fixed sheaths, and the first sub-electrode and the second sub-electrode are fixed to the outside of the same annular sheath at a crossed spacing;
or the first electrode and the second electrode respectively use one fixed sheath, the first sub-electrodes are fixed on the outer sides of the corresponding annular sheaths at intervals, and the second sub-electrodes are fixed on the outer sides of the corresponding annular sheaths at intervals.
13. The occlusion ablation device of claim 12, wherein when the first electrode and the second electrode share the same fixed sheath, the first sub-electrodes and the second sub-electrodes are alternately arranged on the annular sheath at equal intervals;
when the first electrode and the second electrode respectively use one fixed sheath, the first sub-electrodes are distributed on the annular sheath used by the first conducting wire at equal intervals, and the second sub-electrodes are distributed on the annular sheath used by the second conducting wire at equal intervals.
14. The occlusion ablation device of claim 11, wherein the first sub-electrode and the second sub-electrode are each a sub-metal sheet; the shape of the metal sub-sheet is any one of L shape, strip shape, round shape or triangle shape.
15. The occlusion ablation device of any one of claims 1-14, wherein part or all of the electrode is removably connected to the support skeleton, the portion of the electrode removably connected to the support skeleton being capable of being withdrawn from the body by an external force.
16. The occlusion ablation device of any one of claims 1-14, wherein the support frame is a lattice-like frame made of elastic metal wire braid or elastic metal laser cut heat setting.
17. The occlusion ablation device of any one of claims 1-14, wherein the electrode is made of any one of platinum, platinum-iridium, gold, nickel-titanium, or stainless steel.
CN201911322004.0A 2019-12-19 2019-12-19 Plugging ablation device Pending CN112998838A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024022152A1 (en) * 2022-07-28 2024-02-01 杭州德诺电生理医疗科技有限公司 Ablation system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024022152A1 (en) * 2022-07-28 2024-02-01 杭州德诺电生理医疗科技有限公司 Ablation system

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