Electrode apparatus and balloon catheter

Abstract

The present application relates to an electrode device, comprising a first electrode and a second electrode, the first electrode and the second electrode are attracted to each other and fit together when the electrode device is not powered, and a gap is formed between the first electrode and the second electrode when the electrode device is powered. The present application also relates to a balloon catheter, comprising the electrode device as described above, and further comprising a balloon and a catheter, the balloon is sleeved on the distal end of the catheter, and the electrode device is arranged on the catheter in the balloon. The present application can adjust the size of the current of the electrode device according to the severity of the patient's condition, thereby adjusting the gap between the first electrode and the second electrode, adjusting the size and amount of the bubbles formed in the gap, and adjusting the intensity of the sound pressure wave conducted to the lesion site through the medium in the balloon and the balloon wall. The operation time can be reduced, the pulse frequency of the vibration wave balloon catheter can be reduced, the service life of the vibration wave balloon catheter can be increased, and the economic burden of the patient can be reduced.

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 solution to the technical problem of the present invention is to provide an electrode device, which includes a first electrode and a second electrode. When the electrode device is not energized, the first electrode and the second electrode can attract and adhere to each other. When the electrode device is energized, a gap can be formed between the first electrode and the second electrode.

[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 are separated.

[0007] 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, a second electrode wire, and a demagnetizing coil. The first electrode wire is connected to the first electrode, the second electrode wire is connected to the second electrode, and the demagnetizing coil is wound around the outer surface of the magnetic first electrode or the second electrode.

[0008] In some embodiments of the present invention, the electrode device further includes an elastic device, which includes a T-shaped rod and a spring, the spring being sleeved on the T-shaped rod; a first receiving groove is provided on the side of the first electrode near the second electrode, the T-shaped rod is housed in the first receiving groove, and the T-shaped rod can move relative to the first electrode within the first receiving groove.

[0009] In some embodiments of the present invention, one end of the spring is connected to the end of the T-shaped rod away from the second electrode, and the other end of the spring is connected to the inner wall of the first receiving groove near the second electrode.

[0010] In some embodiments of the present invention, one end of the T-shaped rod near the second electrode is exposed outside the first receiving groove, and the second electrode is provided with a second receiving groove at the position corresponding to the first receiving groove; when the electrode device is not energized, the part of the T-shaped rod exposed outside the first receiving groove is housed in the second receiving groove, and the spring is in a stretched state; when the electrode device is energized, the T-shaped rod moves toward the second electrode.

[0011] In some embodiments of the present invention, the T-shaped rod includes a head end and a rod body, the head end is connected to the rod body, the size of the head end is larger than the size of the rod body, the head end is disposed away from the second electrode, and the rod body is disposed close to the second electrode.

[0012] In some embodiments of the present invention, the first receiving groove includes a head end receiving groove and a rod body receiving groove that are interconnected. The size of the head end receiving groove matches the size of the head end, and the size of the rod body receiving groove matches the size of the rod body. The head end receiving groove is disposed away from the second electrode, and the rod body receiving groove is disposed close to the second electrode. The head end is housed in the head end receiving groove, and a portion of the rod body is housed in both the rod body receiving groove and the head end receiving groove.

[0013] In some embodiments of the present invention, one end of the spring is connected to the side of the head end near the second electrode, and the other end of the spring is connected to the side of the head end receiving groove near the second electrode.

[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 / or the outer surface of the second electrode.

[0015] The solution to the technical problem of the present invention is to provide a balloon catheter, the balloon catheter including the electrode device as described above, the balloon catheter also including a balloon and a catheter, the balloon being sleeved on the distal end of the catheter, and the electrode device being disposed on the catheter inside the balloon. Attached Figure Description

[0016] Figure 1 This is a three-dimensional structural diagram of the electrode device provided in the first embodiment of the present invention.

[0017] Figure 2 This is a front view schematic diagram of the electrode device provided in the first embodiment of the present invention.

[0018] 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.

[0019] Figure 4 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 in the AA direction form a gap.

[0020] Figure 5 This is a schematic cross-sectional view of the second electrode in the AA direction of the electrode device provided in the first embodiment of the present invention.

[0021] Figure 6 This is a schematic diagram of the elastic device structure of the electrode device provided in the first embodiment of the present invention.

[0022] Figure 7 This is a cross-sectional structural diagram of the first electrode in the AA direction of the electrode device provided in the first embodiment of the present invention.

[0023] Figure 8 This is a three-dimensional structural diagram of the electrode device provided in the second embodiment of the present invention.

[0024] Figure 9 This is a three-dimensional structural diagram of the electrode device provided in the third embodiment of the present invention.

[0025] Figure 10 This is a perspective view of the balloon catheter provided in the third embodiment of the present invention.

[0026] Figure 11 This is another perspective view of the balloon catheter provided in the third embodiment of the present invention.

[0027] Explanation of reference numerals in the attached drawings: 100, Electrode device; 11, First electrode; 12, Second electrode; 13, First electrode wire; 14, Second electrode wire; 120, Wiring hole; 15, Elastic device; 151, T-shaped rod; 152, Spring; 111, First receiving groove; 121, Second receiving groove; 1511, Head end; 1512, Rod body; 1111, Head end receiving groove; 1112, Rod body receiving groove; 16, Insulating layer; 200, Electrode device; 21, First electrode; 22, Second electrode; 23. First electrode lead wire; 24. Second electrode lead wire; 300. Electrode device; 30. Demagnetizing coil; 31. First electrode; 32. Second electrode; 33. First electrode lead wire; 34. Second electrode lead wire; 351. T-shaped rod; 400. Balloon catheter; 41. Balloon; 42. Catheter; 40. Electrode device; 401. First electrode device; 402. Second electrode device; 403. Third electrode device; 404. Fourth electrode device; 4011. First electrode; 4012. Second electrode. Detailed Implementation

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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".

[0033] Please see Figure 1 and Figure 2The 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 are 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 will break down the gap between the first and second electrodes under high voltage, forming a discharge path. A rapidly expanding and collapsing bubble will form at the arc breakdown point, 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, 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. The first electrode 11 is magnetic, and the second electrode 12 is attracted by the first electrode 11 when no power is applied. 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 north pole of the magnetic field of the first electrode 11 faces the second electrode 12. When the electrode device 100 is not powered, the magnetism of the first electrode 11 will attract the second electrode 12, causing the first electrode 11 and the second electrode 12 to be in contact, at which time there is no gap between the first electrode 11 and the second electrode 12. When it is necessary to form a gap between the first electrode 11 and the second electrode 12, it is necessary to weaken the attractive force of the first electrode 11 on the second electrode 12. By using the right-hand screw rule to determine the direction of the current flowing through the first electrode wire 13, the north pole of the magnetic field formed by the current flowing through the first electrode wire 13 is opposite to the north pole of the magnetic field of the first electrode 11 itself. That is, the north pole of the magnetic field formed by the current flowing through the first electrode wire 13 faces away from the second electrode 12. At this time, the magnetic field formed by the current flowing through the first electrode wire 13 cancels out the magnetic field of the first electrode 11 itself, thereby weakening the attractive force of the first electrode 11 on the second electrode 12. A 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, thus 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 glue bonding, laser welding or soldering, etc.

[0034] 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 positive electrode wire. The N pole of the magnetic field of the first electrode 11 can also be oriented away from the second electrode 12, so the N pole of the magnetic field formed after the current passes through the first electrode wire 13 will be oriented towards the second electrode 12.

[0035] In the first embodiment of the present invention, the first electrode 11 is magnetic, which can be achieved by magnetization. Specifically, to magnetize the first electrode 11, it needs to have 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, thus avoiding demagnetization. Therefore, the material of the first electrode 11 can be neodymium iron boron, cobalt, alnico, etc. Since the first electrode 11 has high coercivity, it can be magnetized by pulse magnetization. The second electrode 12 needs to have the property of being attracted by a magnet and having good conductivity. Therefore, the material of the second electrode 12 can be iron, nickel, cobalt, iron-nickel-cobalt alloy, etc.

[0036] In other specific embodiments of the present invention, the magnetism of the first electrode 11 can be achieved by embedding a permanent magnet. For example, a permanent magnet with its N pole facing the second electrode 12 is embedded inside the first electrode 11. 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 itself inside the first electrode 11. The magnetic field formed after the current passes through the first electrode wire 13 cancels out the magnetic field of the permanent magnet itself. After the electrode device 100 is de-energized, due to the high coercivity of the permanent magnet, even after its own magnetic field cancels out the magnetic field formed after the current passes through the first electrode wire 13, the original magnetism can be retained as much as possible, thereby preventing the magnetism of the permanent magnet from decreasing or disappearing, which would prevent the first electrode 11 and the second electrode 12 from attracting and adsorbing each other. It should be noted that the magnetism of the first electrode 11 is achieved by embedding a permanent magnet. That is, the first electrode 11 itself does not need to be magnetic or magnetized; it only needs to have good conductivity. Therefore, the material of the first electrode 11 can be copper alloy, aluminum alloy, etc. The second electrode 12 needs to be able to be attracted by a magnet and has good conductivity. Therefore, the material of the second electrode 12 can be iron, nickel, cobalt, iron-nickel-cobalt alloy, etc.

[0037] Please see Figure 3 and Figure 4After the attraction between the first electrode 11 and the second electrode 12 weakens, a force is needed to separate the first electrode 11 and the second electrode 12. The electrode device 100 provided in the first embodiment of the present invention further includes an elastic device 15, which generates a pushing force on the second electrode 12 by the first electrode 11, thereby facilitating the separation of the first electrode 11 and the second electrode 12. It can be understood that the elastic device 15 provides a pushing force F1 towards the second electrode 12 to push the second electrode 12 away from the first electrode 11, and the attraction between the first electrode 11 and the second electrode 12 is F2. When 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 formed after the current passes through the first electrode wire 13 cancels out the magnetic field of the first electrode 11 itself, weakening the attraction between the first electrode 11 and the second electrode 12. At this time, the current magnitude of the electrode device 100 is adjusted so that F1 is greater than F2, and the first electrode 11 and the second electrode 12 will be pushed apart by the pushing force F1, thereby forming a gap. The larger the gap between the first electrode 11 and the second electrode 12, the larger the rapidly expanding and collapsing bubble, thus providing a stronger sound pressure wave. That is, by adjusting the current of the electrode device 100, the value of F1 is adjusted. When F1 is greater than F2, a gap forms between the first electrode 11 and the second electrode 12; the larger F1 is, the larger the gap between the first electrode 11 and the second electrode 12 will be. When F1 is less than F2, the first electrode 11 and the second electrode 12 attract and adhere to each other. By adjusting the current of the electrode device 100, the size of the gap between the first electrode 11 and the second electrode 12 is adjusted, thereby adjusting the size of the bubble formed after the electric arc breaks down the medium in 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 wave, reducing the operation time, reducing the number of pulses in the waveguide balloon catheter (one pulse generates one sound pressure wave), increasing the lifespan of the waveguide balloon catheter, and simultaneously reducing the patient's financial burden. For example, under constant current, 10 pulses are required to complete the treatment. This invention provides a higher intensity sound pressure wave by adjusting the current of the electrode device 100, so that the waveguide balloon catheter equipped with the electrode device 100 of this invention can complete the treatment with only 6 pulses, thereby reducing the operation time, reducing the number of pulses of the waveguide balloon catheter, increasing the life of the waveguide balloon catheter, and reducing the number of times the waveguide balloon catheter needs to be replaced, thereby reducing the economic burden on patients.

[0038] Please continue reading. Figure 3 and Figure 4 The elastic device 15 includes a T-shaped rod 151 and a spring 152. The T-shaped rod 151 is made of one or more of polyvinyl chloride, polyethylene, and polypropylene. The spring 152 is sleeved on the T-shaped rod 151. A first receiving groove 111 is formed by recessing the side of the first electrode 11 near the second electrode 12 away from the second electrode 12. The T-shaped rod 151 is housed in the first receiving groove 111 and is movable relative to the first electrode 11 within the first receiving groove 111. The T-shaped rod 151 includes a long strip-shaped T-structure, so the first receiving groove 111 corresponds to a long strip-shaped T-shaped groove recessed into the first electrode 11. Further, one end of the spring 152 is connected to the end of the T-shaped rod 151 away from the second electrode 12, and the other end of the spring 152 is connected to the bottom wall or side wall of the first receiving groove 111 near the second electrode 12. That is, the spring 152 is sleeved on the T-shaped rod 151, and the spring 152 is housed together with the T-shaped rod 151 in the first receiving groove 111. When the first electrode 11 and the second electrode 12 gradually approach and fit together (e.g. Figure 3 As shown in the diagram, the T-shaped rod 151 will gradually move away from the second electrode 12. Since one end of the spring 152 is fixed to the inner wall of the first receiving groove 111, the movement of the T-shaped rod 151 will stretch the spring 152, generating a tension F1. However, the tension F1 of the spring 152 is less than the attraction F2 between the first electrode 11 and the second electrode 12. When the electrode device 100 is energized, the attraction F2 between the first electrode 11 and the second electrode 12 decreases. When the tension F1 of the spring 152 is greater than the attraction between the first electrode 11 and the second electrode 12, the tension F1 of the spring 152 will drive the T-shaped rod 151 to move closer to the second electrode 12. When one end of the T-shaped rod 151 abuts against the second electrode 12, the T-shaped rod 151 will apply a pushing force to the second electrode 12, thereby pushing the second electrode 12 away from the first electrode 11, thus creating a gap between the first electrode 11 and the second electrode 12 (e.g., ...). Figure 4 (As shown).

[0039] Please see Figure 2 - Figure 5To ensure that the first electrode 11 and the second electrode 12 always remain aligned and to avoid misalignment due to positional deviation, in the first embodiment of the present invention, the end of the T-shaped rod 151 near the second electrode 12 protrudes outside the first receiving groove 111, and the second electrode 12 is provided with a second receiving groove 121 corresponding to the position of the first receiving groove 111. When the electrode device 100 is not energized, the first electrode 11 and the second electrode 12 are in contact, and the portion of the T-shaped rod 151 protruding outside the first receiving groove 111 is completely housed within the second receiving groove 121, at which time the spring 152 is in a stretched state. When the electrode device 100 is energized, the stretched spring 152 seeks to return to its original state, thus exerting a pulling force on the T-shaped rod 151, thereby causing the T-shaped rod 151 to move towards the second electrode 12. It is understood that, in the first embodiment of the present invention, in order to prevent the part of the T-shaped rod 151 exposed outside the first receiving groove 111 from slipping out of the second receiving groove 121, the end of the T-shaped rod 151 near the second electrode 12 can be fixedly connected to the second receiving groove 121 by welding, adhesive or other means.

[0040] In other specific embodiments of the present invention, since the T-shaped rod 151 has a portion exposed above the first electrode 11, and the spring 152 exerts a pulling force on the T-shaped rod 151, this pulling force tends to cause the second electrode 12 to always move in the direction of the second electrode 12. Therefore, the second receiving groove 121 can be omitted. Even if the second receiving groove 121 is omitted, the portion of the T-shaped rod 151 exposed above the first electrode 11 will always abut against the second electrode 12. That is, no gap will be generated between the T-shaped rod 151 and the second electrode 12, and there is no situation where the gap between the first electrode 11 and the second electrode 12 cannot be changed because the T-shaped rod 151 does not abut against the second electrode 12.

[0041] Please see Figure 6 and Figure 7In the first embodiment of the present invention, the T-shaped rod 151 includes a head end 1511 and a rod body 1512, wherein the head end 1511 is connected to the rod body 1512. The connection between the head end 1511 and the rod body 1512 can be a detachable connection, so that the rod body 1512 can be replaced when it is worn. The connection between the head end 1511 and the rod body 1512 can also be a fixed connection, or the head end 1511 and the rod body 1512 can be integrally formed. The size of the head end 1511 is larger than the size of the rod body 1512, the head end 1511 is disposed away from the second electrode 12, and the rod body 1512 is disposed close to the second electrode 12. The first receiving groove 111 includes a head end receiving groove 1111 and a rod body receiving groove 1112 that are interconnected, the head end receiving groove 1111 is disposed away from the second electrode 12, and the rod body receiving groove 1112 is disposed close to the second electrode 12. The width L1 of the head end receiving groove 1111 matches the width L2 of the head end 1511, and the width L3 of the rod body receiving groove 1112 matches the width L4 of the rod body 1512, allowing the head end 1511 to move within the head end receiving groove 1111 and the rod body 1512 to move within the rod body receiving groove 1112. That is, the width L1 of the head end receiving groove 1111 is greater than the width of the rod body receiving groove 1112. The head end 1511 is housed within the head end receiving groove 1111, and except for the portion of the rod body 1512 exposed outside the first electrode 11, the remaining portion of the rod body 1512 is housed within both the rod body receiving groove 1112 and the head end receiving groove 1111.

[0042] Specifically, the size L1 of the head end receiving groove 1111 is slightly larger than the size L2 of the head end 1511, allowing the head end 1511 to move within the head end receiving groove 1111. The size L3 of the rod body receiving groove 1112 is slightly larger than the size L4 of the rod body 1512, allowing the rod body 1512 to move within the rod body receiving groove 1112. Simultaneously, since the size of the head end 1511 is larger than the rod body 1512, the size of the rod body receiving groove 1112 is smaller than the head end receiving groove 1111. Therefore, the head end 1511 cannot enter the rod body receiving groove 1112, thus limiting the stroke of the head end 1511 and preventing the T-shaped rod 151 from slipping out of the first electrode 11.

[0043] Please continue reading. Figure 6 and Figure 7In the first embodiment of the present invention, one end of the spring 152 is connected to the side of the head end 1511 near the second electrode 12, and the other end of the spring 152 is connected to the side of the head end receiving groove 1111 near the second electrode 12. That is, the spring 152 is housed in the head end receiving groove 1111, and the head end 1511 will receive the tension of the spring 152 or compress the spring 152.

[0044] It can be understood that the overall working principle of the electrode device 100 is as follows: When the electrode device 100 is not energized, the first electrode 11 and the second electrode 12 are in contact, and the portion of the rod 1512 exposed above the first electrode 11 is housed within the second receiving groove 121 and abuts against the second receiving groove 121, causing the T-shaped rod 151 to move away from the second electrode 12, thereby stretching the spring 152. At this time, the attractive force between the first electrode 11 and the second electrode 12 is greater than the pulling force of the spring 152 on the T-shaped rod 151, thus keeping the first electrode 11 and the second electrode 12 in contact. When the electrode device 100 is energized, the current passes through the first electrode wire 13 wound around the first electrode 11, forming a magnetic field that cancels out the magnetic field of the first electrode 11 itself. At this point, the attractive force between the first electrode 11 and the second electrode 12 weakens. When the attractive force between the first electrode 11 and the second electrode 12 is less than the tension of the spring 152 on the T-shaped rod 151, the spring 152 drives the T-shaped rod 151 to move towards the second electrode 12. The T-shaped rod 151 applies a pushing force to the second electrode 12, thereby separating the first electrode 11 and the second electrode 12 to form a gap. At this time, the electric arc breaks through the gap between the first electrode 11 and the second electrode 12, forming a bubble, thereby providing a sound pressure wave.

[0045] Further, please refer to 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.

[0046] It should be noted that, in the first embodiment of the present invention, by providing the elastic device 15, the attraction between the first electrode 11 and the second electrode 12 only needs to be weakened. Then, the elastic force of the elastic device 15 can create a gap between the first electrode 11 and the second electrode 12. Therefore, it is not necessary to weaken the attraction between the first electrode 11 and the second electrode 12 too much, and the current through the first electrode wire 13 or the second electrode wire 14 does not need to be too large. This avoids the electrode device 100 overheating due to excessive current through the first electrode wire 13 or the second electrode wire 14, which would then cause the balloon catheter to overheat. This further avoids problems such as damage to the balloon catheter, excessive evaporation of the medium inside the balloon due to overheating of the electrode device 100, and damage to blood vessels due to overheating of the balloon catheter.

[0047] Please see Figure 8 The second embodiment of the present invention provides an electrode device 200, which differs from the electrode device 100 provided in the first embodiment in that: the first electrode 21 is non-magnetic, the second electrode 22 is magnetic, and the electrode device 200 does not have an elastic component. The N-pole direction of the magnetic field of the second electrode 22 is opposite to the N-pole direction of the magnetic field formed after the current passes through the first electrode wire 23. For example, the N-pole direction of the magnetic field of the second electrode 22 is towards the first electrode 21, while the N-pole direction of the magnetic field formed after the current passes through the first electrode wire 23 is towards the second electrode 22. Specifically, the working principle of the electrode device 200 is as follows: when the electrode device 200 is not energized, the first electrode 21 and the second electrode 22 are in contact. When the electrode device 200 is energized, the current passes through the first electrode wire 23 wound around the first electrode 21, forming a magnetic field opposite to the N-pole direction of the magnetic field of the second electrode 22. Due to the principle of like poles repelling each other, the first electrode 21 and the second electrode 22 will bounce apart to form a gap. The greater the current in the electrode device 200, the greater the repulsive force between the first electrode 21 and the second electrode 22, and the greater the gap between the first electrode 21 and the second electrode 22. The more and larger the bubbles formed after the electric arc breaks down the gap between the first electrode 21 and the second electrode 22 will be, thus providing a stronger and larger sound pressure wave.

[0048] Please see Figure 9The third embodiment of the present invention provides an electrode device 300, which differs from the electrode device 100 provided in the first embodiment in 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. The first electrode wire 33, the first electrode 31, the T-shaped rod 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 to pass through the demagnetizing coil 30, creating a gap between the first electrode 31 and the second electrode 32. Then, the current can be controlled separately to pass through the first electrode wire 33, and the electric arc breaks down the gap between the first electrode 31 and the second electrode 32, forming a bubble, thereby providing a sound pressure wave. That is, adjusting the size of the gap between the first electrode 31 and the second electrode 32 and generating the sound pressure wave can be controlled separately. This provides users with more functional options and improves the practicality of the product. 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.

[0049] Please see Figure 10 The 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. The balloon 41 is sleeved on the distal end of the catheter 42, and the electrode device 40 is disposed on the catheter 42 located inside the balloon 41. 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 electrode gap, 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.

[0050] Further, please refer to Figure 10 and Figure 11The 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 electrode devices as an example for detailed description. Specifically, each electrode device 40 includes a first electrode device 401, a second electrode device 402, a third electrode device 403, and a fourth electrode device 404. Each of the four electrode devices 40 includes a first electrode 4011 and a second electrode 4012. The first electrode 4011 is fixed to the catheter 42, and the second electrode 4012 is movably sleeved on the catheter 42. The first electrode device 401 and the third electrode device 403 are connected in series in the same circuit, and the second electrode device 402 and the fourth electrode device 404 are connected in series in another circuit.

[0051] When the electrode device 40 is the electrode device 100 of the first embodiment of the present invention, a first current is first applied to the first electrode device 401 and the third electrode device 403, creating a gap between the first electrode device 401 and the first electrode 4011 and the second electrode 4012 of the third electrode device 403. Then, a second current is applied to the second electrode device 402 and the fourth electrode device 404. While a gap is created between the first electrode 4011 and the second electrode 4012 of the second electrode device 402 and the fourth electrode device 404, the first electrode 4011 of the second electrode device 402 will attract the second electrode 4012 of the first electrode device 401. The first electrode 4011 of the third electrode device 403 will attract the second electrode 4012 of the second electrode device 402, and so on. Therefore, the second electrode 4012 is attracted by both its own electrode device and the adjacent electrode device, and the gap between the first electrode 4011 and the second electrode 4012 can be controlled by the combined action of the first current and the second current. Compared to a single circuit controlling the gap between the first electrode 4011 and the second electrode 4012, 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 4011 and the second electrode 4012 is too close, the second electrode 4012 will be quickly attracted to the first electrode 4011 due to its strong 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 4012 of the first electrode device 401 is also attracted by the first electrode 4011 of the second electrode device 402. At this time, when the distance between the first electrode 4011 and the second electrode 4012 of the first electrode device 401 is relatively close, the second electrode 4012 of the first electrode device 401 is restrained by the attractive force of the first electrode 4011 of the second electrode device 402. Therefore, the second electrode 4012 of the first electrode device 401 will not be quickly attracted by the first electrode 4011, thus achieving precise control of the gap distance between the first electrode 4011 and the second electrode 4012. Simultaneously, in the case of two circuits, the current flowing through each circuit is smaller than that flowing through a single circuit, avoiding problems such as overheating due to excessive current.The intensity of the acoustic pressure wave generated by the balloon catheter 400 can also be further controlled. If a weaker acoustic pressure wave intensity is required, only the circuits of the first electrode device 401 and the third electrode device 403, or the circuits of the second electrode device 402 and the fourth electrode device 404, need to be connected. If a stronger acoustic pressure wave intensity is required, the circuits of the first electrode device 401 and the third electrode device 403, as well as the circuits of the second electrode device 402 and the fourth electrode device 404, need to be connected.

[0052] 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 4011 and the second electrode 4012 of the first electrode device 401, the second electrode device 402, the third electrode device 403, and the fourth electrode device 404 are all consistent, and the N pole direction of the magnetic field of the second electrode 4012 is towards the first electrode 4011. A first current can be applied to the first electrode device 401 and the third electrode device 403, so that the magnetism of the first electrode device 401 and the first electrode 4011 of the third electrode device 403 are reversed, and the first electrode 4011 and the second electrode 4012 of the first electrode device 401 and the third electrode device 403 repel each other and create a gap. Subsequently, a second current is applied to the second electrode device 402 and the fourth electrode device 404, causing the magnetic reversal of the first electrode 4011 of the second electrode device 402 and the fourth electrode device 404. While a gap is created by the repulsion between the second electrode device 402 and the first electrode 4011 and second electrode 4012 of the fourth electrode device 404, the first electrode 4011 of the second electrode device 402 exerts a repulsive force on the second electrode 4012 of the first electrode device 401. That is, the second electrode 4012 of the second electrode device 402 is subjected to the repulsive force between the first electrode device 401 and the first electrode 4011 of the second electrode device 402. The second electrode 4012 of the second electrode device 402 is also subjected to the repulsive force between the second electrode device 402 and the first electrode 4011 of the third electrode device 403, and so on. The gap between the first electrode 4011 and the second electrode 4012 can be controlled collaboratively by the first current and the second current. Compared to a single circuit controlling the gap between the first electrode 4011 and the second electrode 4012, using two circuits to collaboratively control the gap allows for more precise control. For example, if the second electrode 4012 of the first electrode device 401 experiences excessive repulsive force from the first electrode 4011, it will quickly move away from the first electrode 4011. By applying a repulsive force from the first electrode 4011 of the second electrode device 402 to the second electrode 4012, this rapid movement of the second electrode 4012 away from the first electrode 4011 can be prevented. Furthermore, in the two-circuit configuration, the current flowing through each circuit is smaller than that of a single circuit, preventing problems such as overheating due to excessive current.The intensity of the acoustic pressure wave generated by the balloon catheter 400 can also be further controlled. If a weaker acoustic pressure wave intensity is required, only the circuits of the first electrode device 401 and the third electrode device 403, or the circuits of the second electrode device 402 and the fourth electrode device 404, need to be connected. If a stronger acoustic pressure wave intensity is required, the circuits of the first electrode device 401 and the third electrode device 403, as well as the circuits of the second electrode device 402 and the fourth electrode device 404, need to be connected.

[0053] 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 4011 and the second electrode 4012. 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 wider. 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 4011 and the second electrode 4012 simply by energizing the electrode devices 40, using the magnetic principle. There is no need to adjust the gap between the first electrode 4011 and the second electrode 4012 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.

[0054] Compared with the prior art, the electrode device of the present invention has the following advantages:

[0055] 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.

[0056] 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, the first electrode and the second electrode can attract each other and stick together. When the electrode device is energized, the first electrode and the second electrode can move relative to each other to form a gap with a variable distance between them. 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 separate.

3. 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, a second electrode wire, and a demagnetizing coil. The first electrode wire is connected to the first electrode, the second electrode wire is connected to the second electrode, and the demagnetizing coil is wound around the outer surface of the magnetic first electrode or the second electrode.

4. The electrode device as described in claim 1, characterized in that: The electrode device further includes an elastic device, which includes a T-shaped rod and a spring, with the spring sleeved on the T-shaped rod; a first receiving groove is provided on the side of the first electrode near the second electrode, the T-shaped rod is housed in the first receiving groove, and the T-shaped rod can move relative to the first electrode within the first receiving groove.

5. The electrode device as described in claim 4, characterized in that: One end of the spring is connected to the end of the T-shaped rod away from the second electrode, and the other end of the spring is connected to the inner wall of the first receiving groove near the second electrode.

6. The electrode device as described in claim 5, characterized in that: The end of the T-shaped rod near the second electrode protrudes outside the first receiving groove, and the second electrode is provided with a second receiving groove at the position corresponding to the first receiving groove; when the electrode device is not powered on, the part of the T-shaped rod protruding outside the first receiving groove is stored in the second receiving groove, and the spring is in a stretched state; when the electrode device is powered on, the T-shaped rod moves toward the second electrode.

7. The electrode device as described in claim 6, characterized in that: The T-shaped rod includes a head end and a rod body. The head end is connected to the rod body. The size of the head end is larger than the size of the rod body. The head end is located away from the second electrode, and the rod body is located close to the second electrode.

8. The electrode device as claimed in claim 7, characterized in that: The first receiving groove includes a head end receiving groove and a rod body receiving groove that are interconnected. The size of the head end receiving groove matches the size of the head end, and the size of the rod body receiving groove matches the size of the rod body. The head end receiving groove is located away from the second electrode, and the rod body receiving groove is located close to the second electrode. The head end is housed in the head end receiving groove, and a portion of the rod body is housed in both the rod body receiving groove and the head end receiving groove.

9. The electrode device as claimed in claim 8, characterized in that: One end of the spring is connected to the side of the head end near the second electrode, and the other end of the spring is connected to the side of the head end receiving groove near the second electrode.

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 / or 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 claimed 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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