Electrode apparatus and balloon catheter

Abstract

The present application relates to a kind of electrode device, be arranged in the balloon inside balloon catheter, and cooperate with the medium in balloon to produce acoustic pressure wave, electrode device includes first electrode and second electrode, when electrode device is not powered, first electrode and second electrode between there is gap, when electrode device is powered, first electrode and second electrode can be close to each other between, to change the length of gap, first electrode and second electrode discharge in gap to produce arc, arc and the medium in gap cooperate to produce acoustic pressure wave.The present application also relates to a kind of balloon catheter, balloon catheter includes as above electrode device, also include balloon and catheter, balloon is sleeved on the distal end of catheter, electrode device is arranged on the catheter in balloon.The present application can be according to the severity of patient's illness, adaptively adjust the size of the current of the electrode device, adjust the gap between first electrode and second electrode, further adjust the intensity of acoustic pressure wave that is conducted to pathological site by the medium in balloon and balloon wall.

Description

Technical Field

[0001] This invention relates to the field of interventional medicine, specifically to an electrode device and a balloon catheter. Background Technology

[0002] Interventional therapy is a rapidly developing emerging discipline that integrates imaging diagnosis and clinical treatment. It has now become one of the three pillar disciplines in clinical practice, alongside traditional internal medicine and surgery. Peripheral balloon dilation catheters are primarily used for peripheral arterial diseases. Their basic principle is to dilate the balloon to cause the atherosclerotic plaque to break up, thereby increasing the lumen diameter.

[0003] Generally, the longer the lesion's blood vessel length, the more likely it is to be located across or below the knee joint, and the harder the lesion, the worse the treatment outcome. Lesions with severe calcification increase the difficulty of lumen preparation, directly impacting not only the immediate success rate of the surgery but also the long-term efficacy. In recent years, intravascular shockwave therapy, touted as a "calcification terminator," has rapidly gained attention in the academic community due to its considerable safety and efficacy data. Currently available shockwave balloons provide a fixed amount of acoustic pressure waves, requiring multiple, fixed pulses to treat different calcified lesions within the blood vessel. Furthermore, shockwave balloons have a limited maximum number of pulses and a specified usage time; exceeding these limits necessitates catheter replacement, which is detrimental to the surgical process and increases the financial burden on patients. Summary of the Invention

[0004] To overcome the problems existing in the prior art, the present invention provides an electrode device.

[0005] The present invention provides an electrode device for use in a balloon catheter. The electrode device is disposed inside the balloon of the balloon catheter and interacts with the medium inside the balloon to generate sound pressure waves. The electrode device includes a first electrode and a second electrode. When the electrode device is not energized, there is a gap between the first electrode and the second electrode. When the electrode device is energized, the first electrode and the second electrode can move closer to each other to change the length of the gap. The first electrode and the second electrode discharge within the gap to generate an electric arc, and the electric arc interacts with the medium within the gap to generate sound pressure waves.

[0006] In some embodiments of the present invention, the first electrode or the second electrode is magnetic, and the electrode device further includes a first electrode wire and a second electrode wire. The first electrode wire or the second electrode wire is wound around the outer surface of the first electrode or the outer surface of the second electrode, and the second electrode wire or the first electrode wire is in contact with the second electrode or the first electrode. When the electrode device is energized, the first electrode and the second electrode can approach each other.

[0007] In some embodiments of the present invention, a permanent magnet is disposed in the first electrode or the second electrode, and the material of the first electrode or the second electrode in which the permanent magnet is disposed is one or a combination of soft iron, iron-cobalt alloy, and nickel-iron alloy.

[0008] In some embodiments of the present invention, both the first electrode and the second electrode are magnetic, and the first electrode and the second electrode repel each other; the electrode device further includes a first electrode wire and a second electrode wire, the first electrode wire or the second electrode wire is wound around the outer surface of the first electrode or the outer surface of the second electrode, the second electrode wire or the first electrode wire is in contact with the second electrode or the first electrode, and when the electrode device is energized, the first electrode and the second electrode move closer to each other.

[0009] In some embodiments of the present invention, permanent magnets are disposed in the first electrode and the second electrode, and the material of the first electrode or the second electrode is one or a combination of soft iron, iron-cobalt alloy, and nickel-iron alloy.

[0010] In some embodiments of the present invention, the electrode device further includes an elastic device, which includes a rod and a spring, one end of the spring being connected to one end of the rod; a first receiving groove is provided on the side of the first electrode near the second electrode, the elastic device is housed in the first receiving groove, and the rod can move relative to the first electrode within the first receiving groove.

[0011] In some embodiments of the present invention, one end of the spring is connected to the inner wall of the first receiving groove away from the second electrode, the other end of the spring is connected to one end of the rod, and the other end of the rod is exposed outside the first receiving groove.

[0012] In some embodiments of the present invention, one end of the rod exposed outside the first receiving groove abuts against the second electrode. When the electrode device is energized, the rod moves toward the spring, and the spring shortens.

[0013] In some embodiments of the present invention, the second electrode is provided with a second receiving groove corresponding to the position of the first receiving groove, and the end of the rod that is exposed outside the first receiving groove is received in the second receiving groove; when the electrode device is energized, the rod moves toward the direction of the spring, and the spring becomes shorter.

[0014] In some embodiments of the present invention, the electrode device further includes an insulating layer disposed on the outer surface of the first electrode and the outer surface of the second electrode.

[0015] The present invention provides a balloon catheter that includes an electrode device as described in any of the preceding claims. The balloon catheter also includes a balloon and a conduit. The balloon is fitted over the distal end of the conduit, and the electrode device is disposed on the conduit within the balloon.

[0016] In some embodiments of the present invention, the balloon catheter includes a plurality of electrode devices, which are spaced apart on the catheter within the balloon, and adjacent electrode devices are connected to different circuits.

[0017] The beneficial effects of this invention are as follows: The electrode device and balloon catheter provided by this invention can adaptively adjust the current of the electrode device according to the severity of the patient's condition, thereby adjusting the gap between the first and second electrodes, adjusting the size and quantity of the air bubbles formed at the gap, and thus adjusting the intensity of the sound pressure waves transmitted to the lesion site through the balloon medium and balloon wall. This can reduce operation time, reduce the number of pulses of the shockwave balloon catheter, increase the lifespan of the shockwave balloon catheter, and at the same time reduce the economic burden on patients. Attached Figure Description

[0018] Figure 1 This is a three-dimensional structural diagram of the electrode device provided in the first embodiment of the present invention.

[0019] Figure 2 This is a front view schematic diagram of the electrode device provided in the first embodiment of the present invention.

[0020] Figure 3 This is a schematic cross-sectional view of the electrode device provided in the first embodiment of the present invention when the first electrode and the second electrode are attached in the AA direction.

[0021] Figure 4 This is a three-dimensional structural diagram of the electrode device provided in the second embodiment of the present invention.

[0022] Figure 5 This is a schematic cross-sectional view of the electrode device provided in the second embodiment of the present invention, with the first electrode and the second electrode spaced apart in the BB direction.

[0023] Figure 6 This is a schematic cross-sectional view of the electrode device provided in the second embodiment of the present invention when the first electrode and the second electrode in the BB direction are attached.

[0024] Figure 7 This is a schematic diagram of the cross-sectional structure of the first electrode and the second electrode in the BB direction of the electrode device provided in another embodiment of the second embodiment of the present invention.

[0025] Figure 8This is a schematic diagram of the cross-sectional structure of the second electrode in the BB direction of the electrode device provided in another embodiment of the second embodiment of the present invention.

[0026] Figure 9 This is a three-dimensional structural diagram of the electrode device provided in the third embodiment of the present invention.

[0027] Figure 10 This is a perspective view of the balloon catheter provided in the third embodiment of the present invention.

[0028] Figure 11 This is another perspective view of the balloon catheter provided in the third embodiment of the present invention.

[0029] Explanation of reference numerals in the attached diagram: 100, Electrode device; 10, Permanent magnet; 11, First electrode; 12, Second electrode; 13, First electrode wire; 14, Second electrode wire; 120, Wiring hole; 16, Insulating layer; 200, Electrode device; 21, First electrode; 22, Second electrode; 23, First electrode wire; 24, Second electrode wire; 25, Elastic device; 251, Rod; 252, Spring; 211, First receiving groove; 221, Second receiving groove; 300, Electrode device; 30, Demagnetizing coil; 31, First electrode; 32, Second electrode; 33, First electrode wire; 34, Second electrode wire; 351, Rod; 400, Balloon catheter; 41, Balloon; 42, Catheter; 40, Electrode device; 401, First electrode; 402, Second electrode; 43, First electrode device; 44, Second electrode device; 45, Third electrode device; 46, Fourth electrode device. Detailed Implementation

[0030] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0031] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0032] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0033] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0034] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, "proximal" refers to the end closest to the operator during the surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0035] Please see Figure 1The first embodiment of this invention provides an electrode device 100 for use in a balloon catheter to generate acoustic pressure waves, thereby making the balloon catheter a shockwave balloon catheter. The acoustic pressure waves are conducted to the lesion site through the medium inside the balloon and the balloon wall to treat vascular diseases such as arteriosclerosis obliterans. The working principle of the shockwave balloon catheter is as follows: a medium, such as contrast fluid and physiological saline, is mixed in equal proportions and filled into the balloon, with a gap between the first electrode and the second electrode; after a pulsed electrical signal is applied, the electrodes, under the action of high voltage, will break down the medium in the gap between the first and second electrodes, forming a discharge path. At the point of arc breakdown, a rapidly expanding and collapsing bubble will form, thereby generating acoustic pressure waves. The electrode device 100 provided in the first embodiment of this invention can change the size of the gap between the first and second electrodes, thereby controlling the magnitude of the acoustic pressure waves. Specifically, the electrode device 100 includes a first electrode 11, a second electrode 12, a first electrode lead 13, and a second electrode lead 14. The first electrode 11 is the positive electrode, and the second electrode 12 is the negative electrode. The first electrode wire 13 is the positive electrode wire, and the second electrode wire 14 is the negative electrode wire. Both the first electrode 11 and the second electrode 12 are magnetic. One end of the first electrode wire 13 is wound around the outer surface of the first electrode 11, and the other end is connected to the positive terminal of the power supply (not shown). One end of the second electrode wire 14 is in contact with the second electrode 12, and the other end is connected to the negative terminal of the power supply (not shown). The power supply can be alternating current or direct current. The direction of the N pole of the magnetic field of the first electrode 11 is opposite to the direction of the N pole of the magnetic field of the second electrode 12, or the direction of the S pole of the magnetic field of the first electrode 11 is opposite to the direction of the S pole of the magnetic field of the second electrode 12, that is, the first electrode 11 and the second electrode 12 repel each other when they have the same pole. In the first embodiment of the present invention, the N pole of the magnetic field of the first electrode 11 is directed towards the second electrode 12, and the N pole of the magnetic field of the second electrode 12 is directed towards the first electrode 11. The first electrode 11 and the second electrode 12 are spaced apart in the initial state when no power is applied. When the first electrode 11 and the second electrode 12 need to be brought close together, the magnetism of the first electrode 11 needs to be eliminated, or the S pole of the magnetic field of the first electrode 11 needs to be directed towards the second electrode 12, so that the opposite poles of the first electrode 11 and the second electrode 12 attract each other. Using the right-hand screw rule, the direction of the current through the first electrode wire 13 is set so that the N pole of the magnetic field formed after the current passes through the first electrode wire 13 is opposite to the N pole of the magnetic field of the first electrode 11 itself, that is, the S pole of the magnetic field formed after the current passes through the first electrode wire 13 is directed towards the second electrode 12. In other words, after the electrode device 100 is energized, the first electrode 11 and the second electrode 12 will break down the gap between them under high voltage, forming a discharge path.The magnetic field generated by the current passing through the first electrode wire 13 cancels out the magnetic field of the first electrode 11 itself. As the current gradually increases, the magnetism of the first electrode 11 gradually weakens, the repulsive force between the first electrode 11 and the second electrode 12 decreases, and the gap between the first electrode 11 and the second electrode 12 gradually decreases. Until the strength of the magnetic field generated by the current passing through the first electrode wire 13 is greater than the strength of the magnetic field of the first electrode 11 itself, at which point the first electrode 11 and the second electrode 12 attract each other and come into contact.

[0036] This invention adjusts the current of the electrode device 100, thereby adjusting the gap between the first electrode 11 and the second electrode 12, and consequently the size of the bubble formed after the electric arc breaks down the gap between the first electrode 11 and the second electrode 12, thus providing sound pressure waves of different intensities. In use, the current of the electrode device 100 can be adaptively adjusted according to the severity of the patient's condition, thereby adjusting the intensity of the sound pressure waves, reducing surgical time, reducing the number of pulses required for the waveguide balloon catheter (each pulse generates one sound pressure wave), increasing the lifespan of the waveguide balloon catheter, and alleviating the patient's financial burden. For example, under constant current, treatment requires 10 pulses. This invention, by adjusting the current of the electrode device 100, provides a higher intensity sound pressure wave, allowing the waveguide balloon catheter equipped with the electrode device 100 to complete treatment with only 6 pulses, thereby reducing surgical time, reducing the number of pulses required for the waveguide balloon catheter, increasing the lifespan of the waveguide balloon catheter, reducing the frequency of waveguide balloon catheter replacement, and thus alleviating the patient's financial burden. Meanwhile, the gap between the first electrode 11 and the second electrode 12 is largest when not energized. This means that when the electrode device 100 is energized, the arc breaks down the gap between the first electrode 11 and the second electrode 12, resulting in the most bubbles and the strongest acoustic pressure wave. As the current gradually increases, the gap between the first electrode 11 and the second electrode 12 decreases, the number of bubbles formed after the arc breaks down the gap gradually decreases, and the intensity of the acoustic pressure wave gradually weakens. This allows the shockwave balloon equipped with the electrode device 100 to first generate a strong acoustic pressure wave to quickly fracture harder atherosclerotic plaques, and then adjust the current and acoustic pressure wave intensity according to actual needs to fracture softer atherosclerotic plaques. This avoids excessive consumption of contrast fluid and saline solution in the shockwave balloon due to prolonged generation of strong acoustic pressure waves, thus avoiding frequent replenishment of contrast fluid and saline solution and improving the ease of use of the shockwave balloon.

[0037] This is understandable; please refer to [link / reference]. Figure 1 and Figure 2A wiring hole 120 can be provided on the second electrode 12, and one end of the second electrode wire 14 is housed in the wiring hole 120, thereby completing the contact between the second electrode wire 14 and the second electrode 12. The connection method between the first electrode wire 13 and the first electrode 11, and the connection method between the second electrode wire 14 and the second electrode 12, can be adhesive bonding, laser welding, or soldering, etc.

[0038] In other specific embodiments of the present invention, the first electrode 11 can be a negative electrode, and the second electrode 12 can be a positive electrode. Correspondingly, the first electrode wire 13 is a negative electrode wire, and the second electrode wire 14 is a negative electrode wire. The N pole of the magnetic field of the first electrode 11 itself can also be oriented away from the negative electrode 12. Then, the N pole of the magnetic field formed after the current passes through the positive electrode wire 13 will be oriented towards the negative electrode 12.

[0039] Please see Figure 1 - Figure 3 In the first embodiment of the present invention, the magnetism of the first electrode 11 and the second electrode 12 can be achieved by a built-in permanent magnet 10. Specifically, the first electrode 11 is embedded with a permanent magnet 10 whose N pole faces the second electrode 12. The N pole of the magnetic field formed after the current passes through the first electrode wire 13 is opposite in direction to the N pole of the magnetic field of the permanent magnet 10 itself. The magnetic field formed after the current passes through the first electrode wire 13 cancels out the magnetic field of the permanent magnet 10 itself. After the electrode device 100 is de-energized, because the permanent magnet 10 has high coercivity, even after its own magnetic field cancels out the magnetic field formed after the current passes through the first electrode wire 13, it can retain its original magnetism as much as possible, thereby avoiding the reduction or disappearance of the magnetism of the permanent magnet 10, which would prevent the first electrode 11 and the second electrode 12 from being unable to repel each other.

[0040] It should be noted that the first electrode 11 can be made of a material that is magnetizable, demagnetizes quickly, and is conductive. Specifically, after current flows through the first electrode wire 13, the first electrode 11 needs to be magnetized, so that the first electrode 11 attracts the permanent magnet 10 in the second electrode 12, thereby bringing the first electrode 11 and the second electrode 12 closer together. When the electrode device 100 is de-energized, the first electrode 11 needs to quickly demagnetize itself after the current flows through the first electrode wire 13, thereby avoiding the inability to demagnetize the first electrode 11 and affecting the repulsion between the first electrode 11 and the second electrode 12. Low coercivity materials have the characteristic of rapid demagnetization, therefore the first electrode 11 is a low coercivity material with rapid demagnetization. Magnets with low coercivity can be magnetized by constant current magnetization. As an electrode itself, the first electrode 11 needs to be conductive. Therefore, the material of the first electrode 11 can be one or a combination of soft iron, iron-cobalt alloys, and nickel-iron alloys. The second electrode 12 only needs to have good electrical conductivity. To ensure a stable mutual attraction between the first electrode 11 and the second electrode 12, the second electrode 12 can be made of a material that is attracted by a magnet and has good electrical conductivity. Therefore, the material of the second electrode 12 can be iron, nickel, cobalt, iron-nickel-cobalt alloy, etc. Furthermore, the first electrode 11 can also be made of a material that is attracted by a magnet and has good electrical conductivity. After the magnetism of the permanent magnet 10 of the first electrode 11 is canceled out, the permanent magnet 10 of the second electrode 12 attracts the first electrode 11.

[0041] In the first embodiment of the present invention, the magnetism of the first electrode 11 and the second electrode 12 can also be achieved through magnetization. Specifically, to magnetize the first electrode 11, it needs to possess the property of being magnetizable. As an electrode, the first electrode 11 needs to have good conductivity. After the magnetic field formed by the current passing through the first electrode wire 13 cancels out the magnetic field of the first electrode 11 itself, the first electrode 11 may be demagnetized, causing its own magnetism to decrease or disappear. Therefore, the first electrode 11 needs to have high coercivity so that it can retain its original magnetism as much as possible after the magnetic field formed by the current passing through the first electrode wire 13 cancels out, avoiding demagnetization. Therefore, the material of the first electrode 11 can be neodymium iron boron, cobalt, alnico, etc. Because the first electrode 11 has high coercivity, it can be magnetized by pulse magnetization. The second electrode 12 needs to possess the property of being magnetizable and having good conductivity; therefore, the material of the second electrode 12 can be iron, nickel, cobalt, iron-nickel-cobalt alloy, etc. To avoid the second electrode 12 being affected by the magnetic field formed after the current passes through the first electrode wire 13, the second electrode 12 can also be made of a material with high coercivity. Therefore, the second electrode 12 can also be made of materials such as neodymium iron boron, cobalt, and alnico.

[0042] For further information, please refer to [link / reference]. Figure 3 The electrode device 100 further includes an insulating layer 16, which covers the outer surface of the first electrode 11 and the outer surface of the second electrode 12. By providing the insulating layer 16 on the outer surface of the first electrode 11 and the outer surface of the second electrode 12, the electric arc can be released more concentratedly from the first electrode 11, thereby ensuring the quality and efficiency of the generated sound pressure wave.

[0043] Please see Figure 4The second embodiment of the present invention provides an electrode device 200. The similarities between the electrode device 200 and the electrode device 100 provided in the first embodiment will not be repeated here. The main difference between the electrode device 200 and the electrode device 100 is that only one of the first electrode 21 and the second electrode 22 in the electrode device 200 is magnetic, and the first electrode 21 and the second electrode 22 attract each other. The electrode device 200 also includes an elastic device 25. Specifically, in the second embodiment of the present invention, the first electrode 21 is magnetic, and the second electrode 22 is not magnetic. The second electrode 22 can be attracted by a magnet, that is, the second electrode 22 is attracted by the magnetic first electrode 21. The elastic device 25 is disposed between the first electrode 21 and the second electrode 22. In the initial state, the first electrode 21 and the second electrode 22 are separated by the elastic force of the elastic device 25, thereby forming a gap between the first electrode 21 and the second electrode 22 in the initial state. By using the right-hand screw rule to determine the direction of the current flowing through the first electrode wire 23, the north pole of the magnetic field formed by the current flowing through the first electrode wire 23 is aligned with the north pole of the magnetic field of the first electrode 21 itself. After the electrode device 200 is energized, the magnetic field of the first electrode 21 itself is superimposed on the magnetic field formed by the current flowing through the first electrode wire 23. The first electrode 21 is strengthened by the magnetic field formed by the current flowing through the first electrode wire 23, and the attraction between the first electrode 21 and the second electrode 22 increases. As the current gradually increases, the attraction between the first electrode 21 and the second electrode 22 also gradually increases. The first electrode 21 and the second electrode 22 overcome the elastic force of the elastic device 25 and gradually move closer until the first electrode 21 and the second electrode 22 are in contact.

[0044] Further, please refer to Figure 4 - Figure 6In the second embodiment of the present invention, the elastic device 25 includes a rod 251 and a spring 252, one end of the rod 251 being connected to one end of the spring 252. The rod 251 is made of one or more of polyvinyl chloride, polyethylene, and polypropylene. A first receiving groove 211 is formed in the side near the second electrode 22 facing the first electrode 21 away from the second electrode 12. The spring 252 is housed in the first receiving groove 211, and one end of the spring 252 is fixedly connected to the inner wall of the first receiving groove 211 away from the second electrode 22, and the other end is fixedly connected to one end of the rod 251. The rod 251 can move within the first receiving groove 211. When the electrode device 200 is not energized, the end of the rod 251 away from the spring 252 is exposed outside the first electrode 21, and the exposed end of the rod 251 abuts against the side of the second electrode 22 near the first electrode 21. The spring 252 has a spring force F1 toward the second electrode 22, and the first electrode 21 exerts an attractive force F2 on the second electrode 22. The spring force F1 of the spring 252 is greater than the attractive force F2 exerted by the first electrode 21 on the second electrode 22, causing a gap to exist between the first electrode 21 and the second electrode 22, preventing them from approaching each other. Figure 5 As shown. When the electrode device 200 is energized, the attractive force F2 of the first electrode 21 on the second electrode 22 increases. The first electrode 21 and the second electrode 22 overcome the elastic force F2 of the spring 252 and move closer to each other. The spring 252 is compressed and shortened until the rod 251 is completely housed in the first receiving groove 211. At this point, the first electrode 21 and the second electrode 22 are in contact, as shown. Figure 6 As shown. Then, the power supply to the electrode device 200 is cut off. The magnetism of the first electrode 21 quickly weakens and returns to its initial state, and the attraction force F2 between the first electrode 21 and the second electrode 22 returns to its initial state. At this time, the elastic force F1 of the spring 252 is greater than the attraction force F2 of the first electrode 21 on the second electrode 22. The compressed spring 252 returns to its original shape, thereby driving the rod 251 to move towards the second electrode 22, thus separating the first electrode 21 and the second electrode 22 to form a gap.

[0045] It is understood that in the second embodiment of the present invention, there are two elastic devices 25, which are respectively disposed on opposite sides of the first electrode 21. Meanwhile, the end of the rod 251 that contacts the second electrode 22 can be fixedly connected to the second electrode 22, for example, by welding, applying adhesive, or other methods to achieve a fixed connection between the end of the rod 251 that contacts the second electrode 22 and the side of the second electrode 22 closest to the first electrode 21.

[0046] Please see Figure 7 and Figure 8 In other specific embodiments of the present invention, to ensure that the first electrode 21 and the second electrode 22 always remain aligned and to avoid misalignment due to positional deviation, the second electrode 22 has a second receiving groove 221 formed by recessing the side of the second electrode 22 closest to the first electrode 21 away from the first electrode 21. The end of the rod 251 exposed above the first electrode 21 is housed within the second receiving groove 221, and this exposed end can be fixed to the second receiving groove 221 by welding, gluing, or other methods, thereby preventing positional misalignment between the first electrode 21 and the second electrode 22.

[0047] In the second embodiment of the present invention, the magnetism of the first electrode 21 can also be achieved by magnetization, but the magnetism of the first electrode 21 cannot be achieved by embedding a permanent magnet. This is because if a permanent magnet is embedded in the first electrode 21, the permanent magnet will be magnetized by the magnetic field formed after the current passes through the first electrode wire 23. The magnetism of the permanent magnet will be increased and cannot be eliminated in a short time. Therefore, even if the power supply of the electrode device 200 is cut off, the first electrode 21 and the second electrode 22 will still have a strong attraction and be close to each other, and the gap between the first electrode 21 and the second electrode 22 cannot be adjusted. Therefore, the first electrode 21 can only be made magnetic by magnetization, and the first electrode 21 needs to have the characteristics of being magnetizable, demagnetizing quickly, and conducting electricity. Therefore, the material of the first electrode 21 can be one or a combination of soft iron, iron-cobalt alloys, and nickel-iron alloys. The second electrode 22 needs to have the characteristics of being attracted by a magnet and having good conductivity. Therefore, the material of the second electrode 22 can be iron, nickel, cobalt, iron-nickel-cobalt alloys, etc.

[0048] In other specific embodiments of the present invention, the first electrode 21 may be non-magnetic, while the second electrode 22 may be magnetic, and the second electrode 22 exerts an attractive force on the first electrode 21. The first electrode wire 23 may be wound around the first electrode 21, and the direction of current flow through the first electrode wire 23 is set using the right-hand screw rule, so that the direction of the magnetic field generated by the current passing through the first electrode wire 23 is consistent with the direction of the magnetic field of the second electrode 22 itself. This allows the current to magnetize the first electrode 21 after passing through the first electrode wire 23, and the magnetized first electrode 21 and the second electrode 22 attract each other, enhancing the attractive force between them. In this case, the magnetism of the second electrode 22 can be achieved through a built-in permanent magnet or by magnetization.

[0049] Furthermore, the first electrode wire 23 may not be wound around the first electrode 21; the first electrode wire 23 only contacts the first electrode 21. The second electrode wire 24 may be wound around the second electrode 22. The direction of current flow through the second electrode wire 24 is set using the right-hand screw rule, ensuring that the north pole of the magnetic field formed by the current flowing through the second electrode wire 24 is aligned with the north pole of the magnetic field of the second electrode 22 itself. After the current flows through the second electrode wire 24, the magnetic field formed by the current flowing through the second electrode wire 24 is superimposed on the magnetic field of the second electrode 22 itself, thereby strengthening the magnetism of the second electrode 22. This increases the attractive force of the second electrode 22 on the first electrode 21, thus overcoming the elastic force of the spring 252 to adjust the gap between the first electrode 21 and the second electrode 22. In this case, the magnetism of the second electrode 22 can only be achieved through magnetization.

[0050] In other specific embodiments of the present invention, the first electrode 21 and the second electrode 22 may be configured to be non-magnetic. When the electrode device 200 is energized, the current passes through the magnetic field generated by the first electrode wire 23 or the second electrode wire 24, which magnetizes the first electrode 21 or the second electrode 22, thereby making the first electrode 21 or the second electrode 22 magnetic. The first electrode 21 and the second electrode 22 have an attractive force to each other, so as to adjust the gap between the first electrode 21 and the second electrode 22.

[0051] It should be noted that, in the second embodiment of the present invention, by setting the elastic device 25, the first electrode 21 and the second electrode 22 are initially attracted to each other. Therefore, by simply increasing the attractive force between the first electrode 21 and the second electrode 22 and overcoming the elastic force of the elastic device 25 (which can be set to be as small as possible), the gap distance between the first electrode 21 and the second electrode 22 can be changed. Thus, it is not necessary to pass a large current through the first electrode 21 or the second electrode 22 to reverse their magnetic poles; that is, the current through the first electrode wire 23 or the second electrode wire 24 does not need to be too large. This avoids the electrode device 200 overheating due to excessive current through the first electrode wire 23 or the second electrode wire 24, which in turn causes the balloon catheter to overheat. This further avoids problems such as damage to the balloon catheter, excessive evaporation of the medium inside the balloon, and damage to blood vessels due to overheating of the balloon catheter caused by the electrode device 200.

[0052] Please see Figure 9The third embodiment of the present invention provides an electrode device 300. The similarities between the electrode device 300 and the electrode device 200 provided in the second embodiment will not be repeated here. The difference between the electrode device 300 and the electrode device 100 provided in the second embodiment is that the electrode device 300 further includes a demagnetizing coil 30. The first electrode wire 33 is not wound around the outer surface of the first electrode 31, but only contacts the first electrode 31. The demagnetizing coil 30 is wound around the outer surface of the first electrode 31 or the second electrode 32. The first electrode wire 33, the first electrode 31, the rod body 351, the second electrode 32, the second electrode wire 34, and the external power supply form a separate circuit. The demagnetizing coil 30 forms a separate circuit with the external power supply. In use, the current can be controlled separately through the demagnetizing coil 30 to adjust the gap between the first electrode 31 and the second electrode 32. Then, the current can be controlled separately through the first electrode wire 33. The electric arc breaks down the bubble formed after the gap between the first electrode 31 and the second electrode 32, thereby providing a sound pressure wave. In other words, adjusting the gap between the first electrode 31 and the second electrode 32, as well as generating the sound pressure wave, can be controlled separately. This provides users with more functional options and improves the product's usability. For example, after adjusting the gap between the first electrode 31 and the second electrode 32, the user can control whether the sound pressure wave is generated continuously or intermittently. Alternatively, while generating the sound pressure wave, the user can adjust the gap between the first electrode 31 and the second electrode 32 to adjust the intensity of the sound pressure wave.

[0053] Please see Figure 10The fourth embodiment of the present invention provides a balloon catheter 400, which includes an electrode device 40, which is the electrode device 100 of the first embodiment, the electrode device 200 of the second embodiment, or the electrode device 300 of the third embodiment. Specifically, the balloon catheter 400 also includes a balloon 41 and a catheter 42, with the balloon 41 sleeved on the distal end of the catheter 42. Multiple electrode devices 40 can be provided, connected in parallel, and disposed on the catheter 42 located within the balloon 41. Each electrode device 40 includes a first electrode 401 and a second electrode 402, which can be fixedly mounted on the catheter 42, and movably sleeved on the catheter 42 corresponding to the second electrode 402 or the first electrode 401. The working principle of the balloon catheter 400 is as follows: during use, contrast fluid and physiological saline are mixed in equal proportions and filled into the balloon 41, causing the balloon 41 to inflate at the lesion site. Subsequently, the electrode device 40 is connected to a pulsed electrical signal. Under the action of high voltage, the electrodes of the electrode device 40 will break down the gap between the first electrode 401 and the second electrode 402, forming a discharge path. At the point of arc breakdown, a rapidly expanding and collapsing bubble is formed, thereby generating a sound pressure wave. The sound pressure wave is conducted to the lesion site through the medium inside the balloon 41 and the wall of the balloon 41.

[0054] Further, please refer to Figure 10 and Figure 11 The balloon catheter 400 has a plurality of electrode devices 40, which are spaced apart on the catheter 42. The fourth embodiment of the present invention uses four electrodes as an example for detailed description. Specifically, the electrode devices 40 include a first electrode device 43, a second electrode device 44, a third electrode device 45, and a fourth electrode device 46. Each of the four electrode devices 40 includes a first electrode 401 and a second electrode 402. The first electrode 401 is fixed on the catheter 42, and the second electrode 402 is movably sleeved on the catheter 42. The first electrode device 43 and the third electrode device 45 are connected in series in the same circuit, and the second electrode device 44 and the fourth electrode device 46 are connected in series in another circuit.

[0055] When the electrode device 40 is the electrode device 100 in the first embodiment of the present invention, a first current is first applied to the first electrode device 43 and the third electrode device 45, causing the magnetic reversal of the first electrode 401 of the first electrode device 43 and the third electrode device 45, and the first electrode 401 and the second electrode 402 of the first electrode device 43 and the third electrode device 45 to attract each other. Subsequently, a second current is applied to the second electrode device 44 and the fourth electrode device 46. While the first electrode 401 and the second electrode 402 of the second electrode device 44 and the fourth electrode device 46 are attracting each other, the first electrode 401 of the second electrode device 44 will attract the second electrode 402 of the first electrode device 43. The first electrode 401 of the third electrode device 45 will attract the second electrode 402 of the second electrode device 44, and so on. Therefore, the second electrode 402 is attracted by the attraction of its own electrode device and also by the attraction of the adjacent electrode device. The gap between the first electrode 401 and the second electrode 402 can be controlled by the first current and the second current in a coordinated manner. Compared to a single circuit controlling the gap between the first electrode 401 and the second electrode 402, using two circuits to collaboratively control the gap allows for more precise control of the distance between them. For example, when only the first current is applied, if the distance between the first electrode 401 and the second electrode 402 of the first electrode device 43 is too close, the second electrode 402 will be quickly attracted to the first electrode 401 due to its excessive attraction, making it impossible to precisely adjust the gap between them. When the first current and the second current are simultaneously applied, the second electrode 402 of the first electrode device 43 is also attracted by the first electrode 401 of the second electrode device 44. At this time, when the distance between the first electrode 401 and the first electrode 401 of the first electrode device 43 is relatively close, the first electrode 401 of the first electrode device 43 is restrained by the attraction of the first electrode 401 of the first electrode device 43, and thus will not be quickly attracted by the first electrode 401. This achieves the effect of precisely controlling the gap distance between the first electrode 401 and the first electrode 401. Simultaneously, in the case of two circuits, the current passing through each circuit is smaller than that in the case of one circuit, avoiding problems such as overheating due to excessive current.

[0056] When the electrode device 40 is the electrode device 200 of the second embodiment of the present invention, the magnetic pole directions of the first electrode 401 and the second electrode 402 of the first electrode device 43, the second electrode device 44, the third electrode device 45, and the fourth electrode device 46 are all consistent, and the N pole direction of the magnetic field of the second electrode 402 is towards the first electrode 401. A first current can be applied to the first electrode device 43 and the third electrode device 45, causing the first electrode 401 and the second electrode 402 of the first electrode device 43 and the third electrode device 45 to attract each other closer together. Subsequently, a second current is applied to the second electrode device 44 and the fourth electrode device 46, causing the first electrode 401 and the second electrode 402 of the second electrode device 44 and the fourth electrode device 46 to attract each other closer. Simultaneously, the first electrode 401 of the second electrode device 44 exerts an attractive force on the second electrode 402 of the first electrode device 43; that is, the second electrode 402 of the second electrode device 44 is attracted by the first electrode 43 and the first electrode 401 of the second electrode device 44. The second electrode 402 of the second electrode device 44 is also attracted by the first electrode 44 and the first electrode 401 of the third electrode device 45, and so on. The gap between the first electrode 401 and the second electrode 402 can be controlled collaboratively by the first current and the second current. Compared to a single circuit controlling the gap between the first electrode 401 and the second electrode 402, using two circuits to collaboratively control the gap allows for more precise control of the distance between them. Furthermore, in the two-circuit configuration, each circuit carries a smaller current than a single circuit, preventing overheating and other problems caused by excessive current.

[0057] It should be noted that the spacing between the multiple electrode devices 40 is relatively close to ensure that adjacent electrode devices 40 are not affected by each other's magnetism, thereby ensuring that the two circuits coordinate to control the gap between the first electrode 401 and the second electrode 402. If it is necessary for the multiple electrode devices to be unaffected by each other, the spacing between the multiple electrode devices can simply be set to be larger. In addition, the balloon catheter 400 needs to maintain its stability as much as possible during surgery. The balloon catheter 400 of the present invention can adjust the gap between the first electrode 401 and the second electrode 402 simply by energizing the electrode devices 40, using the magnetic principle. There is no need to adjust the gap between the first electrode 401 and the second electrode 402 through mechanical operation, such as manually moving the balloon catheter handle, which will not cause additional shaking or movement of the balloon catheter 400, thereby improving the stability of the balloon catheter 400 during surgery.

[0058] Compared with the prior art, the electrode device of the present invention has the following advantages:

[0059] The electrode device and balloon catheter provided by this invention can adaptively adjust the current of the electrode device according to the severity of the patient's condition, thereby adjusting the gap between the first and second electrodes, the size and quantity of the air bubbles formed at the gap, and consequently the intensity of the sound pressure waves transmitted to the lesion site through the balloon medium and balloon wall. This can reduce surgical time, reduce the number of pulses in the shockwave balloon catheter, increase the lifespan of the shockwave balloon catheter, and simultaneously reduce the economic burden on patients.

[0060] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An electrode device for use in a balloon catheter, the electrode device being disposed inside the balloon of the balloon catheter and interacting with the medium inside the balloon to generate sound pressure waves, characterized in that: The electrode device includes a first electrode and a second electrode. When the electrode device is not energized, there is a gap between the first electrode and the second electrode. When the electrode device is energized, the first electrode and the second electrode can move closer to each other to change the length of the gap. The first electrode and the second electrode discharge within the gap to generate an electric arc. The electric arc and the medium within the gap cooperate to generate a sound pressure wave.

2. The electrode device as described in claim 1, characterized in that: The first electrode or the second electrode is magnetic. The electrode device further includes a first electrode wire and a second electrode wire. The first electrode wire or the second electrode wire is wound around the outer surface of the first electrode or the outer surface of the second electrode. The second electrode wire or the first electrode wire is in contact with the second electrode or the first electrode. When the electrode device is energized, the first electrode and the second electrode can approach each other.

3. The electrode device as described in claim 2, characterized in that: The first electrode or the second electrode is provided with a permanent magnet, and the material of the first electrode or the second electrode with the permanent magnet is one or a combination of soft iron, iron-cobalt alloy, and nickel-iron alloy.

4. The electrode device as described in claim 1, characterized in that: Both the first electrode and the second electrode are magnetic, and the first electrode and the second electrode repel each other; the electrode device also includes a first electrode wire and a second electrode wire, the first electrode wire or the second electrode wire is wound around the outer surface of the first electrode or the outer surface of the second electrode, the second electrode wire or the first electrode wire is in contact with the second electrode or the first electrode, and when the electrode device is energized, the first electrode and the second electrode move closer to each other.

5. The electrode device as described in claim 4, characterized in that: The first electrode and the second electrode are provided with permanent magnets, and the material of the first electrode or the second electrode is one or a combination of soft iron, iron-cobalt alloy, and nickel-iron alloy.

6. The electrode device as claimed in claim 1, characterized in that: The electrode device further includes an elastic device, which includes a rod and a spring, with one end of the spring connected to one end of the rod. A first receiving groove is provided on the side of the first electrode near the second electrode, and the elastic device is housed in the first receiving groove, and the rod can move relative to the first electrode within the first receiving groove.

7. The electrode device as described in claim 6, characterized in that: One end of the spring is connected to the inner wall of the first receiving groove away from the second electrode, and the other end of the spring is connected to one end of the rod, with the other end of the rod protruding outside the first receiving groove.

8. The electrode device as claimed in claim 7, characterized in that: One end of the rod protruding outside the first receiving groove abuts against the second electrode. When the electrode device is energized, the rod moves toward the spring, and the spring shortens.

9. The electrode device as claimed in claim 8, characterized in that: The second electrode is provided with a second receiving groove corresponding to the position of the first receiving groove, and the part of the rod that is exposed outside the first receiving groove is housed in the second receiving groove; when the electrode device is energized, the rod moves toward the direction of the spring, and the spring becomes shorter.

10. The electrode device according to any one of claims 1-9, characterized in that: The electrode device further includes an insulating layer disposed on the outer surface of the first electrode and the outer surface of the second electrode.

11. A balloon catheter, characterized in that: The balloon catheter includes the electrode device according to any one of claims 1-10, the balloon catheter further includes a balloon and a catheter, the balloon is sleeved on the distal end of the catheter, and the electrode device is disposed on the catheter inside the balloon.

12. The balloon catheter as described in claim 11, characterized in that: The balloon catheter includes multiple electrode devices, which are spaced apart on the catheter inside the balloon, with adjacent electrode devices connected to different circuits.

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