CN112022339A - Non-invasive electrode capable of adjusting area and depth and used for delivering electric pulses and application method - Google Patents
Non-invasive electrode capable of adjusting area and depth and used for delivering electric pulses and application method Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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
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Abstract
The invention relates to a non-invasive electrode capable of adjusting the area and the depth and delivering an electric pulse and an application method thereof. The substrate of the electrode is made of insulating materials, a cable channel is arranged in the electrode substrate, and a conductive electrode slice is arranged at a preset position of the electrode substrate. The electrode can be positioned near the surface, the area can be conveyed to the surface through different pulse conveying schemes according to the size of a preset target, and the depth of the selective pulse electric field can be controlled, so that large-area target tissues can be quickly and accurately ablated, and the damage to normal tissues can be reduced.
Description
Technical Field
The present application relates to a non-invasive electrode and method of delivering electrical pulses that is adjustable in area and depth. More particularly, the present application relates to electrodes for generating irreversible electroporation on cells of a biological tissue or inducing apoptosis of the biological tissue, and methods of controlling the area and depth of a delivered pulsed electric field.
Background
The pulsed electric field ablation technology is a non-thermal non-chemical toxicity selective physical local ablation technology based on the high-voltage pulsed electric field biological effect theory. The non-thermal mechanism of the ablation catheter ensures that the ablation catheter does not generate heat in the ablation process, can protect sensitive tissues such as important blood vessels, bile ducts, nerves and the like, has extremely high precision in the pulse ablation treatment of the boundary of the ablation area, and can effectively control the injury range.
In addition, due to differences in cell structure of different types of cells, the killing threshold of the pulsed electric field for different cells is different, which gives tissue specificity to the pulsed ablation electric field. A large number of researches find that tumor cells and myocardial cells generally have stronger response to pulses than normal cells, and the irreversible electroporation threshold of sensitive tissues such as blood vessels and nerves is higher.
Due to the advantages, the pulsed electric field ablation technology is widely applied to clinical treatment of cancer, atrial fibrillation and other diseases. However, there are some problems to be solved in the pulse ablation technology, such as:
side effects such as arrhythmia, muscle contraction and the like can be generated in the treatment process;
the existing non-invasive electrode has small ablation area and low ablation depth.
Therefore, the controllability of the ablation area is increased to shorten the ablation time of ablation tissues with different sizes, and the electric field distribution is accurately controlled to reduce the stimulation and damage to non-target tissues, so that the adverse effect of treatment on a patient can be favorably reduced. In addition, the application range of the non-invasive electrode is greatly improved by improving the ablation depth, the risks of tumor bleeding, malignant ulcer, delayed healing and the like caused by using the invasive electrode are reduced, and the risks of electric arc generation and skin burn of the needle electrode under high-voltage pulse are reduced.
Most of the current pulse electrodes are various needle electrodes aiming at in-vivo tumors and catheter electrodes for pulmonary vein isolation used for atrial fibrillation treatment. The electrodes used for ablation of superficial tumors are mainly flat plate electrodes, negative pressure electrodes, non-invasive needle electrodes, and an array of elongated penetrating needles for delivering electrical pulses to the deep tissues. A device for emitting a pulsed electric field to the stratum corneum is known from CN106255525A and is primarily used for stratum corneum bacterial inactivation, with an effective pulse depth of no more than 15 microns and a very low ablation depth. CN106388933B discloses an irreversible electroporation device for reducing muscle contraction by using an insulating region to limit an electric field, wherein the main body of the electrode of the device is a needle electrode, which needs to penetrate tissue for use, and has the risk of causing tumor bleeding, malignant ulcer, and delayed healing. Further, US20170035499a1 discloses a cardiac pulsed field ablation device that can deliver pulses to the heart on the order of conventional microseconds, producing only a circular ablation shape.
Disclosure of Invention
The invention aims to provide a non-invasive electrode capable of adjusting the area and the depth and delivering electric pulses and an application method thereof, as well as an expandable medical flexible catheter electrode and a built-in medical flexible catheter electrode. The electrode parts of the electrodes are all provided with triangular convex structures, angles exist among the conductive electrode plates and are used for limiting the distribution of electric fields, and the electrode structure can be used for designing external flat plate type electrodes and internal catheter electrodes. The substrates of all the electrodes are made of insulating materials, cable channels are arranged in the electrode substrates, and meanwhile, conductive electrode plates are arranged on preset positions of the electrode substrates.
The technical scheme of the invention is as follows:
a non-invasive electrode for delivering electrical pulses with adjustable area and depth, which is a hollow grid electrode, comprising: the electrode comprises an electrode substrate, a conductive electrode plate and a control cable;
the electrode substrate is made of hollow insulating materials and is in a hollow grid shape, a triangular protruding structure is arranged on one side (facing to a target ablation tissue for example) of the electrode substrate, conductive electrode plates are arranged on two sides of the protruding structure, and the triangular protruding structure is suitable for being sunk into the target tissue to increase the depth of an effective ablation electric field;
the conductive electrode plates are made of conductive materials, and the angle between the conductive electrode plates can limit the electric field in a target area so as to realize accurate transmission of the pulse electric field;
the electrode substrate is hollow inside to form a hollow pipe network, and a control cable is arranged in the hollow pipe network and can control the electrification, grounding or disconnection of the conductive electrode slice so as to control the shape and depth of the pulse electric field.
Further, the grid shape and size of the electrode substrate may vary; the shape of the grid can be square, rectangular or rhombic; the two sides of the grid may be spaced apart by a distance of 1-15mm or more; the number of meshes may be arbitrarily combined according to the size of the ablation target tissue.
Furthermore, the triangular convex structure is an isosceles triangle, the angle formed by the triangular convex structure and the electrode substrate plane can be any one of 0-90 degrees, and the side length of the triangular convex structure can be changed.
The non-invasive electrode capable of adjusting the area and the depth and delivering the electric pulse can be applied to tissues in vitro and can also meet the requirements of ablation use on the surfaces of organs in vivo, such as the stomach, the trachea, the oral cavity, the uterus, the intestinal tract and the like.
The invention also provides a method for adjusting the area and the depth of the pulse electric field, which applies the non-invasive electrode for delivering the electric pulse with adjustable area and depth and specifically comprises the following steps:
each electrode in the conductive electrode slice array of the electrodes can be independently controlled to be electrified, grounded or disconnected through a control cable; wherein the control cable is fed through the hollow tube network of the electrode substrate and connected to each electrode; the direction of the generated pulsed electric field, as well as the shape, area and depth of the pulsed electric field can be controlled by adjusting the pulse delivery scheme.
The present invention also provides an area and depth adjustable non-invasive expandable medical flexible catheter electrode for delivering electrical pulses comprising: a catheter portion and an electrode portion, the electrode portion disposed within the catheter;
the catheter part comprises a catheter head, an inner cavity and a flexible catheter;
the electrode part comprises an insulating substrate, a conductive electrode plate, a control cable and an electromagnet; when delivering a pulse, the electrode portion may be deployed as a plane facing the pulse delivery area;
the insulation substrate of the electrode part is made of hollow insulation materials, the number of lobes of the insulation substrate is variable, the electrode part is provided with a triangular protruding structure on one side facing the target ablation tissue after the electrode is unfolded, and a conductive electrode slice is arranged on a preset area of the protruding structure;
the conductive electrode plates are made of conductive materials, and an angle is formed between the electrode plates;
the insulating substrate is hollow inside, so that a hollow pipe network is formed, and a control cable and an electromagnet are arranged in the hollow pipe network; one end of the electrode part is fixed on the catheter, the opening and closing of the electrode can be controlled through the electromagnet, and the electrification, grounding or disconnection of the electrode plate is controlled through the control cable so as to control the area and depth of the electric pulse.
The present invention also provides a non-invasive, built-in medical flexible catheter electrode for delivery of electrical pulses, adjustable in area and depth, comprising: a catheter portion and an electrode portion, the electrode portion disposed within the catheter;
the catheter part comprises a catheter head, an inner cavity and a flexible catheter;
the electrode part comprises an insulating substrate, a conductive electrode plate and a control cable; when the pulse is delivered, the built-in electrode part can be pushed out of the catheter and unfolded to form a petal shape;
the insulating substrate of the electrode part is made of hollow insulating materials, the number of lobes of the insulating substrate is variable, a triangular protruding structure is arranged on one side, facing the target ablation tissue, of the electrode part after the electrode part is pushed out, and a conductive electrode slice is arranged in a preset area of the protruding structure;
the conductive electrode plates are made of conductive materials, and an angle is formed between the electrode plates;
the insulating substrate is hollow inside, so that a hollow pipe network is formed, and a control cable is arranged in the hollow pipe network;
one end of the bottom of each electrode is fixed on a flexible catheter, the expansion and retraction of the pulse transmission part are controlled by a handle, and the electrification, grounding or disconnection of the electrode plate is controlled by a control cable so as to control the area and depth of the electric pulse.
Furthermore, the number of the lobes of the insulating substrate of the electrode part is variable, the conductive electrode plates on two sides of the insulating substrate are provided with softened edges, and the area of the conductive electrode plates is variable.
The non-invasive electrode for delivering electric pulses or the expandable medical flexible catheter electrode or the built-in medical flexible catheter electrode with adjustable area and depth further comprises at least one electrode which is electrified and at least one electrode which is grounded when in use, and the conductive electrode slice can bear pulse voltage of 3000-4000V, the pulse width is 0.01-100 microseconds and 1kHZ-1MHZ when in electrification.
According to the non-invasive electrode capable of adjusting the area and the depth and conveying the electric pulse, the expandable medical flexible catheter electrode or the built-in medical flexible catheter electrode, further, the insulating substrate material comprises silicon rubber, polyurethane, polytetrafluoroethylene, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, polyurethane, polyethylene terephthalate, nylon, ABS, polycarbonate and other plastic materials; the conductive electrode sheet material includes but is not limited to gold, silver, copper, carbon nanotubes and other conductive materials; the preparation method of the electrode main body comprises the film preparation technologies of sputtering, screen printing, vacuum evaporation, 3D printing and the like.
According to the non-invasive electrode for delivering electric pulses with adjustable area and depth or the expandable medical flexible catheter electrode or the built-in medical flexible catheter electrode, the conductive electrode is connected to the pulse generator through the control cable, the self-made pulse generator (not listed in the application) can be used, and other existing pulse generators can be used.
Detailed description of the invention:
one aspect of the present application relates to a hollowed out grid electrode for delivering a pulsed therapeutic electric field of controllable area and depth. The electrode main body is made of a hollow latticed insulating material, and a conductive electrode plate is arranged in the preset direction of the electrode main body and provided with a softened edge to reduce a point discharge effect. The electrode can be adhered to the epidermis in use, and the protruding part of the electrode can be sunk into the preset tissue to a certain depth so as to improve the depth of a tumor ablation electric field. The electrode plates and the treatment area form a certain included angle for limiting an effective ablation electric field to be close to the grid unit, and the ablation area is accurately controlled.
In some embodiments of the present application, the openwork grid electrode is applied for treatment of tumors on the skin surface. The skin tumor ablation often causes local tissue defect deformity and is not suitable for large-area epidermal tumors, and the protrusions of the electrode main body can be sunk into the skin and form a certain included angle with a target ablation area, so that compared with a traditional non-invasive electrode, the depth of an effective ablation electric field can be improved to a certain extent, the electric field is limited in a target grid unit area, meanwhile, the pulse voltage delivery scheme is adjusted, the large-area or irregular-shaped ablation area can be accurately controlled, the treatment time is shortened, and the stimulation and damage to non-target tissues are reduced.
In some embodiments of the present application, the electrode substrate and the conductive electrode sheet of the hollow grid electrode are made of flexible materials, are accommodated in a medical flexible catheter, and are delivered to a designated position in a body by the flexible catheter to be deployed for in vivo pulsed electric field delivery.
Another aspect of the present disclosure relates to a method of adjusting ablation area and depth:
control cables are fed through the hollow tube network of the electrode insulator body and connected to each electrode to enable individual control of the conductive electrode pads within each grid for voltage delivery, grounding, or disconnection. In the clinical use process, firstly, the shape and the size of the ablation tissue are confirmed through developing equipment such as CT, B ultrasonic and the like, and the pulse transmission scheme is visually adjusted through the established finite element multi-physical field simulation model of the tissue, so that the area and the depth of pulse ablation are accurately controlled.
In some embodiments of the present application, the direction of the electric field may be controlled by controlling different combinations of the potentials and grounds of the four sets of electrode pads within a grid. This multiple electric field directions facilitates efficient ablation of non-spherical cells, since non-spherical electrodes have different tolerance thresholds for electric fields in different directions.
In some embodiments of the present application, a pulsed therapeutic electric field of a particular shape, area and depth can be delivered to the target area by adjusting the different energization, grounding, or disconnection schemes of the electrode pad arrays within the grid, depending on the size and relative position of the intended ablated tissue. Compared with the traditional electrode, the electrode can realize the simultaneous ablation of large-area irregular tissues, can reduce the ablation time and reduce the ablation dead angle.
Another aspect of the present application relates to an expandable medical catheter electrode for delivering area and depth controllable pulsed therapeutic electric fields to tissue in a body. The electrode includes a catheter portion and an electrode portion. Wherein, the catheter part comprises a catheter head, an inner cavity and a flexible catheter. The electrode part comprises an insulating substrate, a conductive electrode plate, a control cable and an electromagnet. When delivering a pulse, the electrode portions may be deployed in a plane facing the pulse delivery area. The main body of the electrode part is composed of a hollow insulating material, and conductive electrode pads are provided on predetermined regions of the insulating material with an angle therebetween. In addition, one end of the electrode part is fixed on the catheter, the opening and closing of the electrode can be controlled through magnetism, and the electrification, grounding or disconnection of the electrode slice are controlled through a control cable so as to control the area and depth of the electric pulse. Compared with the traditional catheter electrode, the ablation area and depth are larger and the ablation shape is controllable due to the larger electrode area and the controllable pulse voltage delivery scheme.
In some embodiments of the present application, the electrode portion of the expandable medical catheter electrode comprises 8 petals, each petal electrode is provided with a conductive electrode slice at the two side planes, and the angle between the two side electrode slices is 45 degrees. One of the 8-valve electrodes is fixed on the medical flexible catheter, and the rest electrodes are controlled to be unfolded and closed through electromagnets. When the electromagnet is electrified, the electrode part is closed to form a cylinder shape and is tightly attached to the flexible conduit. When the electromagnet is energized, the electrode portions spread out to form a plane. The electrification, grounding or disconnection of the electrode plates are controlled through the control cable, and the area and the depth of the electric pulse can be controlled.
Another aspect of the present application relates to an in-line medical catheter electrode for delivering area and depth controllable pulsed therapeutic electric fields to tissue in the body. The electrode catheter portion and the electrode portion. Wherein, the catheter part comprises a catheter head, an inner cavity and a flexible catheter. The electrode part includes an insulating substrate, a conductive electrode sheet, and a control cable. When the impulse is delivered, the built-in electrode portion can be pushed out of the catheter and expanded to form a petal shape. The main body of the electrode part is composed of a hollow insulating material, and conductive electrode pads are provided on predetermined regions of the insulating material with an angle therebetween. One end of the bottom of each electrode is fixed on a flexible catheter, the expansion and retraction of the pulse transmission part are controlled by a handle, and the electrification, grounding or disconnection of the electrode plate is controlled by a control cable so as to control the area and depth of the electric pulse. Compared with the traditional catheter electrode, the ablation area and depth are larger and the ablation shape is controllable due to the larger electrode area and the controllable pulse voltage delivery scheme.
In some embodiments of the present application, the electrode portion of the built-in medical catheter electrode comprises 8 petals of electrodes, two sides of the plane of each petal of electrode are respectively provided with a conductive electrode slice, and the angle between the electrode slices at the two sides is 45 degrees. One end of the bottom of the 8-petal electrode is fixed on the flexible catheter, and the expansion and the retraction of the pulse delivery part are controlled by the handle. When the catheter is moved, the built-in electrode part can be closed to form a cylinder shape and is accommodated in the catheter; when delivering the pulse, the built-in electrode portion can be pushed out of the catheter and expanded to form a petal shape, or the electrode can be placed inside the balloon. The electrification, grounding or disconnection of the electrode plates are controlled through the control cable so as to control the area and depth of the electric pulse.
The electrode provided by the invention has a triangular protrusion structure (the electrode can be sunk into target tissue to increase a certain ablation depth, and meanwhile, the electrode plates on the triangular protrusion form a certain angle, so that the distribution of an electric field can be limited, and the damage to non-target tissue is reduced (as shown in fig. 4D, the limitation effect of a triangle with a certain angle on the electric field is better than that of a traditional flat plate or a traditional circle), and the precise control of an ablation area (such as the shape 1, 2 and 3 shown in fig. 9) can be realized by combining a control method).
The electrode can be positioned near the surface, can deliver the area to the surface through different pulse delivery schemes according to the size of a preset target, can rapidly and accurately ablate large-area target tissues and reduce the damage of normal tissues by a selective pulse electric field with controllable depth
Description of the drawings:
FIG. 1 is a schematic diagram of a grid electrode according to an embodiment of the present application;
FIG. 2 is a cell structure of a grid electrode having different convex shapes;
FIG. 3 is a schematic diagram of electric field contour distributions of grid cell electrodes having different convex shapes on a cross section perpendicular to the center of the electrode body;
FIG. 4 is a schematic distribution of contour lines of an electric field of the order of 1500V/cm on a cross section perpendicular to the center of the electrode body for grid cell electrodes having different convex shapes;
FIG. 5 is a schematic distribution diagram of contour lines of an electric field of the order of 1500V/cm on a cross section perpendicular to the center of an electrode body for a grid cell electrode having triangular projections with different angles according to an embodiment of the present application;
FIG. 6 is a graph comparing electric field distributions of triangular raised mesh cell electrodes having different angles according to an embodiment of the present application;
FIG. 7 is a schematic distribution of contours of an electric field of the order of 1500V/cm across a cross-section perpendicular to the center of the electrode body for different size grids in accordance with an embodiment of the present application;
FIG. 8 is a schematic diagram of a grid electrode according to an embodiment of the present application generating electric fields in different directions parallel to a cross-section of the electrode body;
FIG. 9 is a schematic diagram of differently shaped ablation regions produced by one pulse delivery control scheme of a grid electrode according to embodiments of the present application;
FIG. 10 is a graph of electric field contrast at different depths generated under another pulse delivery control scheme for a grid electrode according to an embodiment of the present application;
FIG. 11 is a graph of electric field contrast at different depths generated under another pulse delivery control scheme for a grid electrode according to an embodiment of the present application;
FIG. 12 is an expandable catheter electrode according to an embodiment of the present application;
FIG. 13 is an in-line catheter electrode according to embodiments of the present application.
The specific implementation mode is as follows:
various exemplary embodiments of the present application will now be described in detail with reference to the accompanying drawings. It should be noted that: the relative arrangement of the components and steps set forth in these embodiments, numerical values do not limit the scope of the present application unless specifically stated otherwise.
The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the application, its application, or uses.
FIG. 1 is a schematic diagram of a grid electrode according to an embodiment of the present application
As shown in fig. 1, the hollow grid electrode 11 of the present application is composed of an electrode substrate 12, a conductive electrode sheet 13, and a control cable 14. The electrode substrate is in a hollow grid shape, the electrode substrate 12 is made of a hollow insulating material, the grid shape and size of the electrode substrate can be adjusted according to actual conditions, and meanwhile, an insulating area facing a target tissue can be coated with an adhesive to fix the electrode on the surface of an organ. One side of the grid electrode 11 facing the target tissue is provided with a triangular protruding structure, the size and the angle of the triangular protruding structure are adjustable, and two sides of the protruding structure are provided with conductive electrode plates 13. The triangular raised structures may be recessed into the skin to increase the depth of the effective ablation field when an electrical pulse is delivered to the skin surface. The triangular raised structures of different angles can confine the electric field within the grid cell to different degrees for precise control of the ablation zone, making it applicable to ablation targets of different shapes and sizes. The hollow tubular network of electrode substrates may be used as a cable transport channel to transport control cables 14 to each electrode pad 13 for controlling the voltage at the electrode pads 13, grounding, or disconnecting.
FIG. 2 is a unit structure of a mesh electrode having different convex shapes
Fig. 2(a) is a front view and a side view of a unit electrode 21 having a triangular bump structure, in which an electrode substrate 22 has a square mesh shape and four conductive electrode pads 23 are provided on a predetermined region. The triangular convex structure of the unit electrode 21 is an isosceles triangle, and the angle formed by the triangular convex structure and the electrode substrate plane is 60 degrees. The conductive electrode plate has a softened edge, so that electric arcs generated by the tip under high voltage and local overheating caused by the tip under nanosecond pulse are prevented.
Fig. 2(B) is a front view and a side view of a unit electrode 25 having a semicircular convex structure, in which an electrode substrate 26 has a square lattice shape and four conductive electrode pads 26 are provided on a predetermined region. The conductive electrode pad 26 on the unit electrode 25 has a softened edge and an area equal to that of the conductive electrode pad 23 of the triangular unit electrode 21.
Fig. 2(C) is a front view and a side view of a conventional flat plate-shaped unit electrode 29, in which an electrode base 210 has a square lattice shape and four conductive electrode pads 211 are provided on a predetermined region. The conductive electrode pad 211 on the unit electrode 29 has a softened edge and an area equal to that of the conductive electrode pad 23 of the triangular unit electrode 21.
FIG. 3 is a schematic diagram showing the distribution of electric field contour lines of the grid unit electrodes (flat plate 31, semicircle 32, triangle 33) having different convex shapes shown in FIG. 2 on a cross section perpendicular to the center of the electrode body
Specifically, fig. 3 shows the simulation comparison of the electric field distribution of a conventional flat plate electrode and a grid electrode according to the present application with finite element multi-physical field simulation software using the skin as the targeted ablation tissue. In the simulation, one side of the grid unit electrode bulge faces skin tissues and the triangular bulge is sunk into the skin tissues, 3000V voltage is applied to two adjacent conductive electrode plates in the unit electrode in the simulation, and the other two electrode plates are grounded. FIG. 3 shows the electric field contour distribution of the unit electrodes in a cross section perpendicular to the center of the electrode body after voltage application, showing the intensity distribution of the electric field in the form of contour electric field lines spaced 500V/cm apart, and the intensity of the electric field is shown by the shades of color in the figure. It can be seen that the conventional flat plate electrode 31 has the worst electric field limiting capability, the semicircular convex electrode 32 has the middle electric field limiting capability, and the triangular convex electrode 33 has the strongest electric field limiting capability.
FIG. 4 is a distribution diagram of contour lines of electric fields of 1500V/cm in a cross section perpendicular to the center of the electrode body between a conventional flat plate-like electrode and the grid electrode having a convex structure of the present application.
To further compare the electric field distributions of the unit electrodes of different convex shapes, the irreversible electroporation threshold was set to 1500V/cm, and the region where the electric field strength exceeded 1500V/cm was the ablation region where irreversible electroporation occurred. Fig. 4 is an enlarged view of the contour distribution of the electric field of the order of 1500V/cm in electric field strength on the cross section perpendicular to the center of the electrode body in fig. 3, and compares the electric field distributions of the unit electrodes of different convex structures, fig. 4(a), (B), and (C) corresponding to the conventional flat plate-shaped electrode 41, the semicircular electrode 42, and the triangular electrode 43, respectively. It can be seen that the triangular electrodes 43 and the semicircular electrodes 42 have a larger ablation depth than the conventional flat electrodes 41, and the triangular electrodes can well limit the electric field and control it near the grid cells.
FIG. 5 is a 1500V/cm-order electric field contour of unit electrodes having triangular projections (same electrode pad area) with different angles, and the simulation parameter settings are similar to those of FIG. 3. Fig. 5(a), (B), (C), (D) correspond to 20 degrees, 40 degrees, 60 degrees, 80 degrees, respectively.
Fig. 6 is a comparison of electric field distributions of triangular protrusion unit electrodes of different angles in an electric field of the order of 1500V/cm, in which fig. 6(a)/61 is a comparison between 20 degrees and 40 degrees, fig. 6(B)/62 is a comparison between 40 degrees and 60 degrees, and fig. 6(C)/63 is a comparison between 60 degrees and 80 degrees. It can be seen that the ablation depth of the electrode does not vary much with increasing angle. At angles of 20, 40, 60, the damage to the non-target area decreases with increasing angle of the triangular structure. As the angle increases from 60 degrees to 80 degrees, the lesion to the non-target area increases instead with increasing angle of the triangular structure and the ablation depth decreases. In addition, the electrode angle is not as large as possible, since increasing the angle increases the stress on the patient's organ.
Fig. 7 is a schematic view of the direction of an electric field of a unit electrode having a triangular protrusion structure according to an embodiment of the present application, and the direction of the electric field can be controlled by separately controlling the potentials of four electrode sheets within the unit electrode and grounding. The electric field can be controlled horizontally 71, vertically 72 or obliquely 73. The horizontal electric field 71 and the vertical electric field 72 can be realized by applying voltage to one of two opposite electrode slices in the four electrode slices in the grid unit electrode, grounding the other electrode slice, and disconnecting the other two adjacent electrode slices; the oblique electric field 73 may be realized by applying a voltage to one of two adjacent electrode sheets within the grid cell electrode and grounding the other.
Fig. 8 shows cell mesh sizes of 5 × 5mm, respectively, according to an embodiment of the present application2And 10 x 10mm2The electric field distribution of the unit electrode with the triangular convex structure is shown as follows:
FIG. 8(A) is a distribution of contours (10X 10 mm) of an electric field of 1500V/cm magnitude across a cross section perpendicular to the center of the electrode body when 3000V is applied to two adjacent electrode sheets of the unit electrodes and the other two electrode sheets are grounded2：81；5*5mm2: 82, the width of the single electrode plate is not changed, and the length is 10 x 10mm2Half of the electrode sheet of the unit electrode. ) It can be seen that the increase of the grid spacing of the unit electrodes is beneficial to the increase of the maximum ablation depth, but as the grid spacing increases, the ablation electric field at the central part of the grid electrode is sunken towards the electrode.
FIG. 8(B) is the graph when the alignment is 5X 5mm2One electrode plate of the unit electrode is applied with 3000V voltage, the electrode plate opposite to the electrode plate is grounded, and when the other two electrode plates are disconnected, the contour line distribution 83 of 1500V/cm-level electric field on the central section vertical to the electrode main body is formed. It can be seen that this, while reducing the ablation depth, better limits the electric field.
Because the cables are conveyed through the hollow structure of the electrode main body, the number of cables is increased sharply due to the reduction of the grid units, and the area of the grid units is not small enough; meanwhile, the increase of the electrode spacing can cause the ablation depth between the electrodes to be inconsistent, so the area of the grid unit is not too large.
FIG. 9 is a graphical representation of a distribution of an electric field on the order of 1500V/cm calculated according to one pulse delivery control scheme of the present application. Since each mesh of the mesh electrode and the conductive area within each mesh can be controlled individually to deliver a voltage, to ground, or to be equipotential with the electrode body. Therefore, the ablation area can be controlled by adjusting the scheme to form a certain ablation shape, and compared with the traditional skin electrode, the ablation time can be shortened, and the ablation dead angle can be reduced. Fig. 9 is a schematic diagram of the control effect: by controlling the electrification and grounding of the electrode plates in the grid where the ablation target is located, the pulse electric field is controlled to form the ablation shape with the numbers 1, 2 and 3.
FIG. 10 is a graph comparing electric fields at different depths generated under another pulse delivery control scheme for electrodes according to embodiments of the present application
Since the electrodes are composed of the same unit electrodes in an array form to form a grid electrode, the ablation depth can be controlled by controlling the delivery scheme of the pulse voltage by combining two or four or even more adjacent unit electrodes into one unit electrode for use. For example, four adjacent 5 x 5mm2The square unit electrodes 101 are combined to form a unit electrode with the thickness of 10 x 10mm2The square electrode unit 102. It can be seen that the combination of square element electrodes and a reasonable pulse delivery control scheme can achieve effective ablation at greater depths. And 10mm relative to the aforementioned 10 x 10mm2The square electrode unit 33 is composed of four adjacent 5 x 5mm210 x 10mm formed by combining square unit electrodes2The square electrode units 102 also produce effective ablation at greater depths due to the greater electrode pad area.
FIG. 11 is a graph of an electric field mode contour surface and its electric field contour calculated on the order of 1500V/cm according to another pulse delivery control scheme of the present application, wherein the cell grid size is 10 x 10mm2The triangular projection angle is 60 degrees. In the ablation of some deep tumors, the result isTo a maximum ablation depth, half of the grid electrodes may be fully energized, and the other half grounded. The punch transport control scheme as shown in fig. 11(C) can generate an electric field on the order of 1500V/cm at a depth of about 0.62 cm. Fig. 11(a)/(B)/(C) shows the variation of ablation depth for different number of unit combinations, respectively. Wherein 111 is the voltage of 2 grid electrode slices, and when 2 grid electrode slices are grounded, the maximum ablation depth is distributed on the contour line of 1500V/cm-order electric field on the section. 112 is the isoline distribution of 1500V/cm-order electric field on the section where the maximum ablation depth is located when the electrode plates of the 6 grids are electrified and the electrode plates of the 6 grids are grounded. And 112, 3000V voltage is applied to the electrode plates of the 10 grids, and when the electrode plates of the 10 grids are grounded, the maximum ablation depth is distributed on the contour line of the 1500V/cm-level electric field on the section where the maximum ablation depth is located. It can be seen from FIG. 11(D) that the ablation depth increases with the number of combined unit electrodes, and the lesion decreases with the number of combined unit electrodes for non-target areas.
FIG. 12 is an expandable catheter electrode according to an embodiment of the present application:
FIG. 12(A) is a schematic view of the expandable catheter electrode 121 before it is deployed, and FIG. 12(B) is a schematic view of the catheter 123 after the electrode has been deployed. The electrode 121 includes a catheter portion and an electrode portion. The catheter portion includes a catheter head 122, a lumen 127 and a flexible catheter 126. The electrode portion includes an electrode base 124, a conductive electrode sheet 125, a control cable, and an electromagnet 128. The guide tube head 122 is guided by a traction wire control, and when the wire is drawn from the trailing end, the leading end is bent toward one side due to a force applied to one side. The electrode part of the catheter electrode comprises 8 petals of electrodes, a conductive electrode plate 125 is arranged on each of the two side planes of each petal of electrode, and the angle between the two electrode plates is 45 degrees. One of the 8-petal electrodes is fixed on a medical flexible catheter, and the rest electrodes are controlled to be unfolded and closed through electromagnets 128. When the electromagnet is electrified, the electrode part is closed to form a cylinder shape and is tightly attached to the flexible conduit. When the electromagnet is energized, the electrode portions are deployed to form a plane for delivering electrical pulses to the target tissue. The conductive electrode pads 125 have softened edges to prevent arcing at the tip under high voltage and local overheating at the tip under nanosecond pulses. The insulating base 124 is hollow for conveying cables, and each conductive electrode piece 125 can be individually controlled to be energized, grounded or disconnected.
FIG. 13 is an in-line catheter electrode according to embodiments of the present application:
fig. 13(a) is a schematic view of the built-in catheter electrode 131 before deployment, and fig. 13(B) is a schematic view of the catheter 133 after deployment. The electrode 131 includes a catheter portion and an electrode portion. The catheter portion includes a catheter head 132, an inner lumen 137, and a flexible catheter 136. The electrode part includes an electrode base 134, a conductive electrode sheet 135 and a control cable. The guide tube head 132 is guided by a pull wire control, and when the wire is pulled from the trailing end, the leading end is bent toward one side due to a force applied to one side. The electrode part of the catheter electrode comprises 8-petal electrodes, two sides of the plane of each petal electrode are respectively provided with a conductive electrode plate 135, and the angle between the two electrode plates is 45 degrees. One end of the bottom of the 8-petal electrode is fixed on the flexible catheter, and the expansion and the retraction of the pulse delivery part are controlled by the handle. When the catheter is moved, the built-in electrode part can be closed to form a cylinder shape and is accommodated in the catheter; when a pulse is delivered, the built-in electrode portion can be pushed out of the catheter and expanded to form a petal shape. The conductive electrode pads 135 have softened edges to prevent arcing at the tip under high voltage and local overheating of the tip under nanosecond pulses. The electrode body 134 is hollow inside for conveying cables, and each conductive electrode piece 135 can be individually controlled to be energized, grounded or disconnected.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and decorations can be made without departing from the concept of the present invention, and these modifications and decorations should also be regarded as being within the protection scope of the present invention.
Claims (10)
1. A non-invasive electrode for delivering electrical pulses with adjustable area and depth, characterized in that it is a hollow grid electrode comprising: the electrode comprises an electrode substrate, a conductive electrode plate and a control cable;
the electrode substrate is made of hollow insulating materials and is in a hollow grid shape, a triangular protruding structure is arranged on one side of the electrode substrate facing a target ablation tissue, conductive electrode plates are arranged on two sides of the protruding structure, and the triangular protruding structure is suitable for being sunk into the target tissue to increase the depth of an effective ablation electric field;
the conductive electrode plates are made of conductive materials, and the angle between the conductive electrode plates can limit the electric field in a target area so as to realize accurate transmission of the pulse electric field;
the electrode substrate is hollow, so that a hollow pipe network is formed; and a control cable is arranged in the hollow pipe network and can control the electrification, grounding or disconnection of the conductive electrode plates so as to control the shape and depth of the pulse electric field.
2. The adjustable area and depth non-invasive electrode for delivering electrical pulses of claim 1, wherein the electrode substrate has a variable mesh shape and size; the shape of the grid can be square, rectangular or rhombic; the two sides of the grid may be spaced apart by a distance of 1-15mm or more; the number of meshes may be arbitrarily combined according to the size of the ablation target tissue.
3. The non-invasive electrode for delivering electrical pulses with adjustable area and depth as claimed in claim 1, wherein the triangular convex structures are isosceles triangles that form an angle with the plane of the electrode substrate that can be anywhere from 0 to 90 degrees, and the side length of the triangular convex structures can be varied.
4. The non-invasive electrode for delivering electrical pulses with adjustable area and depth according to claim 1, wherein the electrode can be applied not only to tissues outside the body, but also to organs inside the body, such as the stomach, trachea, mouth, uterus, and intestine.
5. A method for adjusting the area and depth of a pulsed electric field using the non-invasive electrode for delivering electric pulses with adjustable area and depth of claim 1, comprising the steps of:
each electrode in the conductive electrode slice array of the electrodes can be independently controlled to be electrified, grounded or disconnected through a control cable; wherein the control cable is fed through the hollow tube network of the electrode substrate and connected to each electrode; the direction of the generated pulsed electric field, as well as the shape, area and depth of the pulsed electric field can be controlled by adjusting the pulse delivery scheme.
6. A non-invasive expandable medical flexible catheter electrode for delivering electrical impulses with adjustable area and depth, comprising: a catheter portion and an electrode portion, the electrode portion disposed within the catheter;
the catheter part comprises a catheter head, an inner cavity and a flexible catheter; the electrode part comprises an insulating substrate, a conductive electrode plate, a control cable and an electromagnet; when delivering a pulse, the electrode portion may be deployed as a plane facing the pulse delivery area;
the insulating substrate of the electrode part is made of hollow insulating materials, and the number of lobes of the insulating substrate is variable; after the electrode is unfolded, a triangular protruding structure is arranged on one side, facing the target ablation tissue, of the insulating substrate, and a conductive electrode slice is arranged in a preset area of the protruding structure;
the conductive electrode plates are made of conductive materials, and an angle is formed between the electrode plates;
the insulating substrate is hollow inside, so that a hollow pipe network is formed, and a control cable and an electromagnet are arranged in the hollow pipe network;
one end of the electrode part is fixed on the catheter, the opening and closing of the electrode can be controlled through the electromagnet, and the electrification, grounding or disconnection of the electrode plate is controlled through the control cable so as to control the area and depth of the electric pulse.
7. An area and depth adjustable, non-invasive, built-in medical flexible catheter electrode for delivery of electrical pulses, comprising: a catheter portion and an electrode portion, the electrode portion disposed within the catheter;
the catheter part comprises a catheter head, an inner cavity and a flexible catheter;
the electrode part comprises an insulating substrate, a conductive electrode plate and a control cable; when the pulse is delivered, the built-in electrode part can be pushed out of the catheter and unfolded to form a petal shape;
the insulating substrate of the electrode part is made of hollow insulating materials, the number of lobes of the insulating substrate is variable, a triangular protruding structure is arranged on one side, facing the target ablation tissue, of the electrode part after the electrode part is pushed out, and a conductive electrode slice is arranged in a preset area of the protruding structure;
the conductive electrode plates are made of conductive materials, and an angle is formed between the electrode plates;
the insulating substrate is hollow inside, so that a hollow pipe network is formed, and a control cable is arranged in the hollow pipe network;
one end of the bottom of each electrode is fixed on a flexible catheter, the expansion and retraction of the pulse transmission part are controlled by a handle, and the electrification, grounding or disconnection of the electrode plate is controlled by a control cable so as to control the area and depth of the electric pulse.
8. The area and depth adjustable non-invasive electrode for delivering electrical pulses according to any one of claims 1 to 4 or the expandable flexible medical catheter electrode according to claim 6 or the built-in flexible medical catheter electrode according to claim 7, wherein the conductive electrode sheet has a flexible edge, the area of the conductive electrode sheet is variable, and the area of the conductive electrode sheet comprises at least one electrode and at least one electrode which are grounded when the electrode sheet is electrified, and the conductive electrode sheet can bear 3000-4000V, the pulse width is 0.01-100 microseconds, and the pulse voltage is 1kHZ-1MHZ when the electrode sheet is electrified.
9. The expandable flexible catheter for medical use according to claim 6 or the built-in flexible catheter for medical use according to claim 7, wherein the electrode insulating substrate is made of a plastic material selected from the group consisting of silicone rubber, polyurethane, polytetrafluoroethylene, polyethylene, polypropylene, polyvinyl chloride, polymethyl methacrylate, polyurethane, polyethylene terephthalate, nylon, ABS, polycarbonate, etc.; the conductive electrode sheet material includes but is not limited to gold, silver, copper, platinum, zinc, graphene, carbon nanotubes, steel, cast iron, tungsten alloy and other various conductive materials; the electrode preparation method comprises the film preparation technologies of sputtering, screen printing, vacuum evaporation, 3D printing and the like.
10. The adjustable area and depth non-invasive electrode for delivery of electrical impulses as claimed in any one of claims 1 to 4 or the expandable flexible medical catheter electrode as claimed in claim 6 or the built-in flexible medical catheter electrode as claimed in claim 7 wherein the conductive electrode is connected to the impulse generator by a control cable, either a self-made impulse generator or other existing impulse generator can be used.
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| CN202010844584.6A CN112022339B (en) | 2020-08-20 | Area and depth adjustable non-invasive electrode for delivering electric pulse and application method |
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| CN202010844584.6A CN112022339B (en) | 2020-08-20 | Area and depth adjustable non-invasive electrode for delivering electric pulse and application method |
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