A pulse ablation device

Abstract

An embodiment of the present specification provides a pulse ablation device, which includes: a balloon and a plurality of electrodes printed on the outer surface of the balloon; wherein the connection lines of at least two of the plurality of electrodes constitute the longitude lines of the outer surface of the balloon, and the connection lines of at least another two of the plurality of electrodes constitute the latitude lines of the outer surface of the balloon.

Description

Technical Field

[0001] The present specification relates to the technical field of medical devices, and in particular to a pulse ablation device. Background Art

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia and the most serious disorder of atrial electrical activity. The occurrence of AF includes triggering factors that induce arrhythmia and the substrate that maintains it. The triggering factors are diverse, including sympathetic or parasympathetic nerve stimulation, bradycardia, atrial premature beats or tachycardia, atrioventricular bypass and acute atrial stretch. Recent studies have found that many triggering factors come from ectopic excitation points of the muscle sleeves at the junction of the pulmonary vein or vena cava and atrial tissue. Radiofrequency ablation can eliminate atrial fibrillation by electrically isolating the electrical connection between these veins and the atrium. At present, for patients with paroxysmal atrial fibrillation, the ablation strategy of performing circumferential pulmonary vein ablation and achieving pulmonary vein electrical isolation as the end point has become a safe, effective and easy-to-operate treatment method. When the current pulse ablation device performs pulse ablation, not all electrodes can be well attached to the pulmonary vein, affecting the ablation effect. Therefore, a pulse ablation device with better electrode attachment is needed. Summary of the invention

[0003] One of the embodiments of the present specification provides a pulse ablation device, which includes: a balloon and a plurality of electrodes printed on the outer surface of the balloon; wherein the connection lines of at least two of the plurality of electrodes constitute the longitude lines of the outer surface of the balloon, and the connection lines of at least another two of the plurality of electrodes constitute the latitude lines of the outer surface of the balloon.

[0004] In some embodiments, the device further comprises an energy processing unit, wherein the energy processing unit records the preset coordinates of each of the plurality of electrodes.

[0005] In some embodiments, adjacent electrodes on the longitude lines formed by the electrode connection lines have the same latitude gradient; adjacent electrodes on the latitude lines formed by the electrode connection lines have the same longitude gradient; and the preset coordinates are determined based on the latitude gradient and the longitude gradient.

[0006] In some embodiments, the electrodes are used to detect physiological signals; and the energy processing unit determines the abutment status of the electrodes based on the physiological signals.

[0007] In some embodiments, the energy processing unit determines that different electrodes correspond to form different annular electrode groups based on the abutment conditions of the electrodes.

[0008] In some embodiments, the energy processing unit allocates cathodes and anodes in the annular electrode set based on spherical distance.

[0009] In some embodiments, each of the electrodes is connected to the energy processing unit via a separate wire.

[0010] In some embodiments, the electrodes are filled and arranged on the outer surface of the balloon, and any one of the electrodes has a plurality of adjacent filling positions, each of the filling positions has an equal spherical distance to the electrode, and an adjacent electrode of any one of the electrodes is arranged in at least one of the filling positions.

[0011] In some embodiments, the shape of the electrode includes a circle, and the diameter of the circle ranges from 0.5 mm to 1.5 mm; the distance between adjacent electrodes is 5 to 10 times the diameter of the electrode.

[0012] In some embodiments, the electrodes are printed on the outer surface of the distal hemisphere of the balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] This specification will be further described in the form of exemplary embodiments, which will be described in detail by the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

[0014] Figure 1 is a schematic diagram of the structure of a pulse ablation device according to some embodiments of this specification;

[0015] Figure 2 is a schematic diagram of the structure of a balloon according to some embodiments of this specification;

[0016] Figure 3 is a schematic diagram of the structure of a balloon according to some embodiments of this specification;

[0017] Figure 4 is a schematic diagram of the structure of a balloon according to some embodiments of this specification;

[0018] Figure 5 is a schematic diagram of coordinate calculation according to some embodiments of this specification;

[0019] Figure 6 is a schematic diagram of a process of pulse ablation according to some embodiments of this specification;

[0020] Figure 7 It is a schematic diagram of the abutment status of the pulse ablation device according to some embodiments of the present specification. DETAILED DESCRIPTION

[0021] In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some examples or embodiments of this specification. For ordinary technicians in this field, this specification can also be applied to other similar scenarios based on these drawings without creative work. Unless it is obvious from the language environment or otherwise explained, the same reference numerals in the figures represent the same structure or operation.

[0022] It should be understood that the "system", "device", "unit" and / or "module" used herein are a method for distinguishing different components, elements, parts, portions or assemblies at different levels. However, if other words can achieve the same purpose, the words can be replaced by other expressions.

[0023] As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and / or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0024] Flowcharts are used in this specification to illustrate the operations performed by the system according to the embodiments of this specification. It should be understood that the preceding or following operations are not necessarily performed precisely in order. Instead, the steps may be processed in reverse order or simultaneously. At the same time, other operations may also be added to these processes, or one or more operations may be removed from these processes.

[0025] Figure 1 1 is a schematic diagram of the structure of the pulse ablation device 100 according to some embodiments of the present specification. The pulse ablation device 100 involved in the embodiments of the present specification will be described in detail below. It should be noted that the following embodiments are only used to explain the present application and do not constitute a limitation on the present application.

[0026] The pulse ablation device 100 is used for pulsed electric field ablation. Pulsed electric field ablation refers to applying high-voltage electric pulses to the phospholipid bilayer of the cell membrane in a short period of time, which rearranges under the action of the electric field to form nanoscale hydrophilic pores, thereby increasing the permeability of the cell membrane. If the electric field strength is low and the application time is short, the resulting pore size is small, and the cell membrane quickly reseals the pores after the electric field is applied. This process is called reversible electroporation. If the electric field strength is high and the application time is long, large pores and multiple pores will be formed on the cell membrane, leading to the leakage of potassium ions and enzymes, and intracellular calcium ion overload. Ultimately, the intracellular homeostasis is destroyed, and the cells go to apoptosis or necrosis. This process is called irreversible electroporation. During pulsed electric field ablation treatment, irreversible electroporation is mainly used to cause irreversible damage to cells, thereby achieving the effect of pulmonary vein isolation; as the pulse width increases or the electric field strength increases, the cells gradually change from reversible electroporation to irreversible electroporation; when the electric field strength or application time increases to a certain threshold, heat can also be generated, leading to thermal damage.

[0027] like Figure 1 As shown, in some embodiments, the pulse ablation device 100 may include a balloon 110 and a handle 140, one end of the handle 140 is extended with a catheter 120, and the balloon 110 is arranged at the end of the catheter 120 away from the handle 140. In some embodiments, the balloon 110 can be attached to ablation target tissues such as pulmonary veins for implementing circumferential pulmonary vein ablation. In some embodiments, the handle 140 can be used for an operator to hold. In some embodiments, a catheter bending button 130 can be provided on the handle 140 to adjust the direction of the curved catheter 120 so that the balloon 110 can better attach to the ablation target tissue.

[0028] Figure 2 It is a schematic diagram of the structure of the balloon 110 shown in some embodiments of this specification.

[0029] In some embodiments, Figure 2 As shown, the pulse ablation device 100 may include a balloon 110 and a plurality of electrodes 111 printed on the outer surface of the balloon 110. In some embodiments, the connection lines of at least two of the plurality of electrodes 111 may constitute the warp lines of the outer surface of the balloon 110, and the connection lines of at least another two of the plurality of electrodes 111 may constitute the weft lines of the outer surface of the balloon 110.

[0030] In some embodiments, the pulse ablation device 100 further includes a catheter 120, which is inserted into the proximal end of the balloon 110 and exits from the distal end of the balloon 110, wherein the proximal end refers to the end of the balloon close to the operator, and the distal end refers to the end of the balloon away from the operator. In some embodiments, the catheter 120 can control the movement of the balloon 110 to a certain extent.

[0031] In some embodiments, the balloon 110 may be made of non-compliant material, that is, no matter how much pressure is added, the diameter of the balloon 110 remains unchanged after reaching a specified size, which is conducive to better contact with the ablation target tissue. As an example only, the material of the balloon 110 can be PET, nylon, etc.

[0032] In some embodiments, the balloon 110 may be made of insulating material so that only the electrode 111 portion of the balloon 110 can conduct electricity, which is beneficial to the accuracy of positioning the electrode 111 and the concentration of ablation energy to achieve deeper damage.

[0033] The electrode 111 is an input or output current terminal for conducting electricity, wherein one pole for input current is an anode and one pole for output current is a cathode. The material of the electrode 111 can be a conductive material, such as carbon nanotubes, graphene, composite materials, polymer materials, nanomaterials, nanowires, etc. The conductivity of the electrode 111 must be ensured, and the resistance must be small, such as a resistance measurement of less than 3Ω. In addition, the material of the electrode 111 selected is easy to deform to avoid affecting the flexibility of the balloon 110.

[0034] In some embodiments, the shape of the electrode 111 includes but is not limited to a circle, a square, a polygon, etc. When the electrode 111 is circular, the diameter of the circle ranges from 0.5 mm to 1.5 mm. When the diameter of the electrode 111 is too small, the distance between the two electrodes 111 must be small enough, otherwise the damage cannot form a circular continuous damage, and will be abnormally conducted, that is, conducted through an undamaged part, resulting in failure of the treatment. When the diameter of the electrode 111 is too large, the area of ​​the tissue is prone to overheating, and the voltage it withstands will be greatly limited. Therefore, when the electrode 111 is 0.5-1.5 mm in diameter, the damage formed and the voltage it withstands are more appropriate. Preferably, the diameter of the electrode 111 is 1 mm.

[0035] In some embodiments, the electrode 111 is printed on the surface of the balloon 110. The printed flexible electrode 111 is combined with the balloon and always remains on the outer surface of the balloon during the balloon inflation and deflation process, which can improve the fit between the electrode 111 and the pulmonary vein. In other embodiments, the electrode 111 can also be set on the surface of the balloon 110 by other methods, such as integral molding, bonding, etc.

[0036] In some embodiments, the electrode 111 can be printed on the entire surface of the balloon 110. In some embodiments, the electrode 111 can be printed on the outer surface of the distal hemisphere of the balloon 110. Since the outer surface of the balloon 110 is a spherical curved surface, it changes from small to large and then to small from the distal end to the proximal end. After the diameter of the balloon 110 reaches the maximum position, the proximal hemisphere is difficult to be attached to the tissue due to the reduced radius. Therefore, the distal hemisphere of the balloon 110 is the position that mainly attaches to the ablation target tissue.

[0037] In some embodiments, the electrodes 111 may be arranged in any form on the outer surface of the balloon 110, as long as they can cover the outer surface of the balloon 110 or the outer surface of the distal hemisphere of the balloon 110. In some embodiments, the electrodes 111 may be arranged according to a preset rule to facilitate coordinate positioning and printing.

[0038] Figure 3 Schematic diagram of the structure of the balloon according to some embodiments of this specification. Figure 3 As shown, in some embodiments, the electrodes 111 may be arranged based on the meridians 113 and the latitudes 114 of the balloon 110. The meridians 113 may be a plurality of arcs of equal length on the outer surface of the balloon 110 connecting the distal end point and the proximal end point, and the direction of the meridians 113 may be the extension direction of the catheter 120 ( Figure 1 The weft line 114 may be a direction in which the balloon 110 extends around the catheter 120 (a direction), and each of the warp lines 113 connects the connection position between the proximal end of the balloon 110 and the catheter 120 and the connection position between the distal end of the balloon 110 and the catheter 120. Figure 1 When the spherical surface is rotated in the direction of a, the trajectory of a point on the spherical surface forms a circle, the latitude line 114 can be a number of circles of different lengths, and the longitude line 113 and the latitude line 114 are perpendicular to each other. In some embodiments, the connection line of at least two of the multiple electrodes 111 can constitute the longitude line of the outer surface of the balloon 110, and the connection line of at least another two of the multiple electrodes 111 can constitute the latitude line of the outer surface of the balloon 110. In a specific embodiment, the multiple longitude lines 113 and the multiple latitude lines 114 on the outer surface of the balloon 110 intersect, and the electrode 111 can be set at the intersection of the longitude line 113 and the latitude line 114.

[0039] In some embodiments, the central axis of the catheter 120 inserted into the balloon 110 can be used as the axis, the cross section passing through the center of the balloon 110 and perpendicular to the axis can be used as the equatorial plane, and the intersection of the equatorial plane and the outer surface of the balloon 110 can be used as the zero degree latitude; the far end of the zero degree latitude (far from the operator end) is called the northern hemisphere, and the proximal end of the zero degree latitude (close to the operator end) is called the southern hemisphere; the angle between the line connecting any electrode 111 on the outer surface of the balloon 110 and the center of the balloon 110 and the equatorial plane is called the latitude of the point, which is the north latitude in the northern hemisphere and the south latitude in the southern hemisphere. At the same time, a certain meridian can be defined as the zero degree meridian, and the method for determining other meridians is to use the angle between the plane formed by the meridian and the axis and the plane formed by the zero degree meridian and the axis, which is called the longitude of the meridian. For example, the meridians to the west of the zero degree meridian are called the west longitude, and those to the east are called the east longitude, and the 180° east and west longitudes overlap exactly. Longitude and latitude can conveniently calibrate any electrode 111 on the outer surface of the balloon 110, for example, electrode M (30 degrees north latitude, 124 degrees east longitude), electrode N (34 degrees south latitude, 120.5 degrees west longitude), etc.

[0040] In some embodiments, adjacent electrodes on the meridian 113 formed by the connection of the electrodes 111 may have the same latitude gradient; adjacent electrodes on the latitude 114 formed by the connection of the electrodes 111 may have the same longitude gradient. That is, the latitudes between adjacent electrodes 111 in the meridian direction are equal, and the longitudes between adjacent electrodes 111 in the latitude direction are also equal, so as to facilitate coordinate positioning and printing. In a specific embodiment, based on the coordinates of a known electrode, the coordinates of other electrodes can be easily obtained according to the arrangement characteristics of the electrode 111 on the balloon 110 and its spacing relationship with the adjacent electrode.

[0041] Figure 4 Schematic diagram of the structure of the balloon according to some embodiments of this specification. Figure 4 As shown, in some embodiments, the electrodes 111 can be filled and arranged on the outer surface of the balloon 110, and any one of the electrodes 111 has multiple adjacent filling positions, and the spherical distance from each filling position to the electrode 111 is equal, and the adjacent electrodes of any one electrode are arranged in at least one filling position.

[0042] In some embodiments, the lines connecting the filling positions of any electrode may form a regular polygon, and the any electrode is located at the centroid of the regular polygon. Figure 4 Any electrode has 6 filling positions, and the 6 filling positions form a regular hexagon. The electrode is located at the centroid of the regular hexagon, so that the distances from the 6 filling positions to the electrode are equal.

[0043] In some embodiments, when the electrode 111 is located near the catheter 120, its filling position may be blocked by the catheter 120, and the filling position blocked by the catheter 120 may not be filled with the electrode 111, and the filling position not blocked by the catheter 120 may be filled with the electrode 111. In some embodiments, the electrode 111 is filled and arranged in the distal hemisphere of the outer surface of the balloon 110, and part of the filling position of the electrode 111 close to the equatorial plane may be located in the proximal hemisphere of the balloon 110, and no electrode is filled in the filling position located in the proximal hemisphere.

[0044] In some embodiments, the filling of the electrode 111 can be started from the distal end point of the balloon 110. First, the filling positions adjacent to the distal end point are determined. After the electrodes 111 are filled in these filling positions, the filling positions are continued to be determined based on the newly filled electrodes 111 until the distal hemisphere of the balloon 110 is filled with electrodes 111.

[0045] In some embodiments, the electrodes 111 on the outer surface of the balloon 110 can be positioned according to spatial coordinates, and the coordinates of any electrode 111 on the spherical surface can be expressed as (r, θ, φ).

[0046] Figure 5 is a schematic diagram of coordinate calculation according to some embodiments of this specification. Figure 5 As shown, in the coordinates (r, θ, φ) of any electrode 111, r represents the distance between the electrode 111 (the center point) and the origin, and the origin is usually selected as the center of the sphere O. π / 2-θ corresponds to the angle between the line connecting the electrode 111 and the origin and the z-axis. φ represents the angle between the projection of the line connecting the electrode 111 and the origin on the XOY plane and the X-axis. Among them, the value ranges of r, θ, φ are r∈[0,+∞), θ∈[0,π], and φ∈[0,2π].

[0047] In some embodiments, according to the arrangement characteristics of the electrode 111 on the balloon 110 and the spherical distance relationship between the electrode 111 and the adjacent electrodes, the coordinates of other electrodes can be easily calculated according to a known electrode coordinate.

[0048] In some embodiments, the distance between adjacent electrodes can be 5-10 times the diameter of the electrode. Since the diameter, spacing, and voltage of the electrode 111 will affect the degree of damage caused by pulse ablation. Therefore, the value of the distance between adjacent electrodes is related to the size of the electrode 111. For example, when the size of the electrode 111 is 1 mm, the distance between adjacent electrodes can be 10 mm. In the arrangement based on the longitude 113 and the latitude 114, adjacent can refer to the electrodes 111 being adjacent in the longitude direction or the latitude direction. In the filling arrangement, adjacent electrodes can be electrodes that are adjacent at the closest distance.

[0049] In a specific embodiment, for electrodes 111 located on the same latitude, when the distance between two adjacent electrodes 111 exceeds 10 times the electrode diameter, it is necessary to add an electrode 111 between the two electrodes 111; if there are multiple groups of adjacent electrodes 111 on two adjacent longitudes whose distance on the latitude exceeds 10 times the electrode diameter, it is necessary to add an electrode 111 between the two electrodes 111; accordingly, the added multiple electrodes 111 may also be arranged according to the longitude.

[0050] Figure 6 FIG. 1 is a flow chart of pulse ablation according to some embodiments of this specification. Figure 6 As shown, in some embodiments, process 600 includes the following steps.

[0051] Step 610, based on the position of each electrode, determine the preset coordinates of each electrode.

[0052] In some embodiments, after the electrodes are printed on the outer surface of the balloon, the position of each electrode is fixed, and the position of each electrode corresponds to a position coordinate, which can be recorded as a preset coordinate for use in subsequent ablation operations.

[0053] In some embodiments, the pulse ablation device 100 may include an energy processing unit that can record the preset coordinates of each of the plurality of electrodes on the outer surface of the balloon.

[0054] In some embodiments, each electrode can be connected to an energy processing unit via a separate wire, see Figure 2 The middle conductor 112 allows the energy processing unit to control each electrode individually.

[0055] In some embodiments, the preset coordinates of the electrode are edited by using latitude and longitude coordinates, spherical coordinates, spatial coordinate system (XYZ), cylindrical coordinate system, etc.

[0056] In a specific embodiment, the preset coordinates of the electrode can be determined based on longitude and latitude. For more information about determining coordinates using longitude and latitude, please refer to the above related description. In some embodiments, the preset coordinates can be determined based on latitude gradients and longitude gradients. For example, adjacent electrodes on the longitude have the same latitude gradient of 3 degrees; adjacent electrodes on the latitude have the same longitude gradient of 15 degrees. Based on electrode M (30 degrees north latitude, 124 degrees east longitude), the coordinates of its four adjacent electrodes can be obtained as needed. They are (33 degrees north latitude, 124 degrees east longitude), (27 degrees north latitude, 124 degrees east longitude), (30 degrees north latitude, 139 degrees east longitude), (30 degrees north latitude, 109 degrees east longitude).

[0057] In some embodiments, the preset coordinates may also be expressed as (r, θ, φ), for example, electrode N (3, π / 2, π / 4). For more information about the coordinate expression method, see Figure 4 and its description.

[0058] In step 620, the electrodes detect physiological signals.

[0059] In some embodiments, the electrodes can be used to detect physiological signals. When the balloon is attached to the target tissue, the electrodes attached to the tissue can measure the potential changes of the cells.

[0060] Step 630: Determine the contact status of the electrodes based on the physiological signal.

[0061] In some embodiments, the electrode contact condition can be determined based on the feedback of the detected physiological signal and the preset coordinates of the electrode that can detect the signal. If the electrode corresponding to a certain coordinate can output the physiological signal normally, it means that the electrode at that position is well attached. If the electrode corresponding to a certain coordinate cannot output the physiological signal normally, it means that the electrode at that position is not attached well or is not attached to the target tissue. In a specific embodiment, the electrode contact condition can be determined by the energy processing unit based on the physiological signal.

[0062] Figure 7 Schematic diagram of the abutment of the pulse ablation device according to some embodiments of this specification. Figure 7As shown, in a specific embodiment, the diameter of a person's pulmonary vein is mostly between 20 and 30 mm, and the position of the pulmonary vein opening is similar to the shape of a funnel. When the balloon is in contact with the pulmonary vein opening, the contact area is usually a ring, that is, there will be multiple electrodes in the same meridian direction that can be contacted, and the ring can span multiple latitudes. However, when the balloon is in contact, it cannot be guaranteed that it can be well contacted every time. Therefore, based on the physiological signals fed back by the electrodes and the electrode coordinates, the balloon can be moved and contacted multiple times to obtain a good contact situation. In some embodiments, the angle of the balloon moving left and right can be about 30°, such as Figure 7 As shown, the axis (dashed line) can coincide with the catheter of the pulse ablation device.

[0063] Step 640: Based on the abutment condition, determine that different electrodes correspond to form different annular electrode groups.

[0064] In some embodiments, the energy processing unit can determine that different electrodes correspond to different annular electrode groups based on the contact conditions of the electrodes. An annular electrode group refers to a circle of electrodes that are in good contact and can form annular damage. Based on one contact, theoretically, at least one annular band can be in contact with the target tissue, and there are multiple electrodes in the at least one annular band. According to the actual contact conditions of the electrodes on the annular band and the treatment needs, some of the multiple electrodes can be selected to form an annular electrode group.

[0065] In step 650, cathodes and anodes are allocated in the annular electrode group based on the spherical distance.

[0066] In some embodiments, the energy processing unit may allocate cathodes and anodes in the annular electrode set based on spherical distance.

[0067] As an example, first count which latitudes of electrodes are close to each other at the same longitude. Count the electrode latitude gradient α (0<α<15°, for example, 3°, to ensure that there are electrodes close to each other when the balloon is close to each other obliquely), and count the electrode points of 0+n*α. n can be 1, 2, 3, 4, etc.

[0068] Then, count which longitude electrodes are close to each other at the same latitude. Count the extreme values ​​of β at the same latitude based on the longitude gradient β of the electrodes (0<β<30°, for example, 15°, to ensure that the distance between the two electrodes is less than 10 mm. When the distance between the two electrodes is 10 mm, the potential difference between the two electrodes is relatively large without overheating, that is, the depth of damage formed is large).

[0069] Then, based on the spherical distance of the electrodes, the ablation electrodes are selected and paired. The coordinates of the ablation electrodes are C(r,θ,φ), where θ=n*α(n=1, 2, 3, 4...120), φ`min≤φ≤φ`max(φ`min-φ`max=β*2).

[0070] See again Figure 4 Assume that A and B are two paired electrodes on the outer surface of the balloon, and the two electrodes should satisfy ∠AO'B<π / 2. Assume that there are two electrode points A(r,θ1,φ1) and B(r,θ2,φ2) on the balloon, and the spherical distance between the two electrodes is L, then L=r·arc cos[cosθ1cosθ2cos(φ1-φ2)+sinθ1sinθ2].

[0071] When pairing, select appropriate electrodes from the annular electrode group that meets the requirements for abutment. The distance between the paired electrodes should satisfy L≤γ, where γ is the applicable spacing for electrode ablation (γ is 3mm to 5mm under the above values, preferably, γ is 3.7mm). In some embodiments, the value of γ can satisfy the condition of γ<2c, where c is the distance between adjacent electrodes. By controlling the preferred distance γ value, adjacent electrodes are selected to avoid pairing two electrodes that are very far apart. If electrodes that are very far apart are paired, effective therapeutic effects cannot be produced. When electrodes above, below, left, and right are all suitable, electrodes at the same latitude should be preferred, so that the selected electrodes will be more likely to form a ring. It should be noted that the paired electrodes do not have to be located on the same latitude. As long as L meets the requirements, electrode pairing can be arbitrarily selected on the contact ring band, but all electrodes selected in the end must form a ring.

[0072] Step 660, performing pulse ablation.

[0073] In some embodiments, an electric field is applied to the target tissue through selected cathodes and anodes to form large pores and multiple channels on the cell membrane, leading to the leakage of potassium ions and enzymes, intracellular calcium ion overload, and ultimately the destruction of intracellular homeostasis, causing irreversible damage to the cells, thereby achieving the effect of pulmonary vein isolation.

[0074] Step 670, judging the treatment effect based on the physiological signal.

[0075] In some embodiments, after the ablation treatment is completed, the selected electrode for applying the electric field for treatment can be used to detect the potential of the pulmonary vein cells in contact, or other electrodes that are in good contact with the target tissue can be used to detect the potential of the pulmonary vein cells in contact, so as to determine whether the treatment purpose of pulmonary vein potential isolation has been achieved. If pulmonary vein potential isolation is not achieved, the positive and negative electrodes are reassigned, and pulse ablation is performed again until pulmonary vein potential isolation is achieved.

[0076] Step 680, end treatment.

[0077] In some embodiments, treatment ends based on the treatment goal of pulmonary vein potential isolation having been achieved.

[0078] The beneficial effects that may be brought about by the pulse ablation device provided in some embodiments of this specification include but are not limited to: (1) By printing flexible electrodes, the electrodes are combined with the balloon, which greatly improves the adhesion of the electrodes to the target tissue; (2) By using the electrode detection signal feedback, the electrode adhesion conditions can be obtained to achieve precise ablation, avoid the formation of bubbles by electrodes that are not fully attached, and avoid the formation of air emboli; (3) The electrodes are positioned by coordinates, and only the electrodes that are attached to the target tissue can be used according to the positioning to accurately achieve annular damage, form isolation of pulmonary vein potential, and reduce damage to the myocardium and blood vessels; (4) The electrodes are adaptively paired, and only one attachment is required. By adjusting the pairing of the electrodes, ablation can be performed again. By adjusting the pairing of the electrodes for ablation, annular damage can be formed, avoiding multiple adjustments of pulse electrodes. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other beneficial effects that may be obtained.

[0079] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of this specification. Although not explicitly stated here, those skilled in the art may make various modifications, improvements and corrections to this specification. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

[0080] At the same time, this specification uses specific words to describe the embodiments of this specification. For example, "one embodiment", "an embodiment", and / or "some embodiments" refer to a certain feature, structure or characteristic related to at least one embodiment of this specification. Therefore, it should be emphasized and noted that "one embodiment" or "an embodiment" or "an alternative embodiment" mentioned twice or more in different positions in this specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of this specification can be appropriately combined.

[0081] In addition, unless explicitly stated in the claims, the order of the processing elements and sequences described in this specification, the use of alphanumeric characters, or the use of other names are not intended to limit the order of the processes and methods of this specification. Although the above disclosure discusses some embodiments currently considered useful through various examples, it should be understood that such details are only for illustrative purposes, and the attached claims are not limited to the disclosed embodiments. On the contrary, the claims are intended to cover all modifications and equivalent combinations that are consistent with the essence and scope of the embodiments of this specification. For example, although the system components described above can be implemented by hardware devices, they can also be implemented only by software solutions, such as installing the described system on an existing server or mobile device.

[0082] Similarly, it should be noted that in order to simplify the description disclosed in this specification and thus help understand one or more embodiments, in the above description of the embodiments of this specification, multiple features are sometimes combined into one embodiment, figure or description thereof. However, this disclosure method does not mean that the features required by the subject matter of this specification are more than the features mentioned in the claims. In fact, the features of the embodiments are less than all the features of the single embodiment disclosed above.

[0083] In some embodiments, numbers describing the number of components and attributes are used. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise specified, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may change according to the required features of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the setting of such numerical values ​​is as accurate as possible within the feasible range.

[0084] Each patent, patent application, patent application publication, and other materials, such as articles, books, specifications, publications, documents, etc., cited in this specification are hereby incorporated by reference in their entirety. Except for application history documents that are inconsistent with or conflicting with the contents of this specification, documents that limit the broadest scope of the claims of this specification (currently or later attached to this specification) are also excluded. It should be noted that if the descriptions, definitions, and / or use of terms in the materials attached to this specification are inconsistent or conflicting with the contents described in this specification, the descriptions, definitions, and / or use of terms in this specification shall prevail.

[0085] Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, as an example and not a limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly introduced and described in this specification.

Claims

1. A pulse ablation device, characterized in that: The device comprises: a balloon and a plurality of electrodes printed on an outer surface of the balloon; wherein the connection line of at least two of the plurality of electrodes constitutes the longitude line of the outer surface of the balloon, and the connection line of at least another two of the plurality of electrodes constitutes the latitude line of the outer surface of the balloon; The device further comprises an energy processing unit, wherein the energy processing unit records the preset coordinates of each of the plurality of electrodes; Adjacent electrodes on the longitude formed by the electrode connection lines have the same latitude gradient; adjacent electrodes on the latitude formed by the electrode connection lines have the same longitude gradient; the preset coordinates are determined based on the latitude gradient and the longitude gradient; The electrodes are used to detect physiological signals; and the energy processing unit determines the contact status of the electrodes based on the physiological signals.

2. The pulse ablation device according to claim 1, characterized in that: The energy processing unit determines that different electrodes correspond to form different annular electrode groups based on the contact conditions of the electrodes.

3. The pulse ablation device according to claim 2, characterized in that: The energy processing unit allocates cathodes and anodes in the annular electrode group based on spherical distance.

4. The pulse ablation device according to claim 1, characterized in that: Each of the electrodes is connected to the energy processing unit via a separate wire.

5. The pulse ablation device according to claim 1, characterized in that: The electrodes are filled and arranged on the outer surface of the balloon, and any one of the electrodes has a plurality of adjacent filling positions, each of the filling positions has an equal spherical distance to the electrode, and an adjacent electrode of any one of the electrodes is arranged in at least one of the filling positions.

6. The pulse ablation device according to any one of claims 1 to 5, characterized in that: The shape of the electrode includes a circle, and the diameter of the circle ranges from 0.5mm to 1.5mm; the distance between adjacent electrodes is 5 to 10 times the diameter of the electrode.

7. The pulse ablation device according to claim 1, characterized in that: The electrodes are printed on the outer surface of the distal hemisphere of the balloon.

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