Electrode Balloon Catheter

Abstract

The present invention relates to an electrode balloon catheter, comprising a catheter body, an outer balloon, an inner balloon and an electrode pair, wherein the electrode pair is arranged on the surface of the inner balloon, the inner balloon and the outer balloon are both arranged at the end of the catheter body, the inner balloon is located inside the outer balloon, and the outer balloon is used to store a conductive medium. The present invention can adjust the position of the electrode through the inner balloon, thereby adjusting the propagation distance of energy, ultimately improving the efficiency of lesion treatment, reducing the operation time, and increasing the service life of the electrode.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an electrode balloon catheter. Background Art

[0002] With the continuous development of percutaneous coronary intervention (PCI), the lesions involved are becoming more and more complex. Coronary artery calcification has always been a difficulty and risk in interventional treatment, especially severe calcification, or complex calcification with distortion, angulation, and diffusion. Correctly identifying and evaluating calcification and selecting appropriate interventional treatment techniques are the key to improving the success rate of surgery, reducing surgery-related complications, and improving patients' short- and long-term prognosis.

[0003] Previously, the common method for treating calcification lesions was to expand the lesion site with a balloon, but this can easily lead to pneumatic damage to the balloon, causing tearing of the vascular endothelium, leading to thrombosis, restenosis and other problems. The shock wave balloon catheter based on the hydrostatic effect can destroy the fibrosis and calcified plaques in the blood vessels, achieving rapid destruction and expansion of the calcification lesions. The principle of the shock wave balloon catheter is to generate a high-voltage pulse electric field in the blood vessel and generate a short duration (<10ms) to form a sound wave with strong sound pressure. This high-energy sound wave propagates to the calcified plaque on the blood vessel, similar to the fracture of any fragile object. The stress generated by the shock wave causes the calcification to begin to form cracks. Under the repeated action of shock waves, these calcification cracks further disintegrate and break, allowing the calcification lesions to expand at low pressure, avoiding the problem of sudden excessive expansion of the balloon under high pressure in traditional angioplasty, which causes damage to the blood vessel wall.

[0004] At present, the electrodes of shock wave balloon catheters are mostly arranged on the catheter of the balloon catheter, which is far away from the outer position of the balloon, and the energy density of the shock wave decreases exponentially with the increase of the propagation distance. The larger spacing greatly reduces the effect of the shock wave on the diseased tissue, thereby increasing the operation time and the number of electrode releases, which can easily lead to long-term expansion of blood vessels and blockage of blood flow, causing ischemic complications. At the same time, increasing the number of shock wave releases also puts more stringent requirements on the life of the electrode, further affecting the size of the electrode material and the permeability of the catheter, and increasing the manufacturing cost of the product. Moreover, for asymmetric calcification in blood vessels, the existing shock wave balloon catheter is difficult to deal with more serious eccentric lesions, and it is difficult to deal with asymmetric calcification in a directional manner. Therefore, while the shock wave balloon catheter based on the hydroelectric effect shows excellent therapeutic effects, the disadvantages of the device itself are also revealed. The main problem is that the shock wave release source is far away from the location of the lesion, and it is difficult to deal with asymmetric calcification foci in a directional manner. Summary of the invention

[0005] In order to solve the problems existing in the prior art, the present invention provides an electrode balloon catheter, which can adjust the position of the electrode, thereby adjusting the propagation distance of the shock wave, improving the efficiency of lesion treatment, reducing the operation time, and increasing the service life of the electrode. At the same time, it has the advantages of simple structure and convenient surgical operation.

[0006] To achieve the above object, the present invention provides an electrode balloon catheter, comprising:

[0007] Catheter body;

[0008] An outer balloon, disposed at the end of the catheter body and used to store a conductive medium;

[0009] an inner balloon, disposed at the end of the catheter body and located inside the outer balloon; and,

[0010] an electrode pair, for receiving high voltage pulses to generate shock waves, and at least one of the electrode pairs is disposed on the surface of the inner balloon;

[0011] The outer balloon is expanded to fit the target object, and the inner balloon drives the electrode pair away from or close to the target object through expansion.

[0012] Optionally, at least one of the electrode pairs is disposed on the outer surface of the inner balloon.

[0013] Optionally, the electrode pair includes a positive electrode and a negative electrode, the positive electrode and the negative electrode are insulated from each other, and an insulation distance between the positive electrode and the negative electrode is fixed or variable.

[0014] Optionally, an insulation distance between the positive electrode and the negative electrode is configured to be within a preset range.

[0015] Optionally, the preset range is 0.01 mm to 10 mm.

[0016] Optionally, the electrode pair includes a positive electrode and a negative electrode, the positive electrode and the negative electrode are insulated from each other, and the positive electrode and the negative electrode are rigidly connected or flexibly connected or not connected.

[0017] Optionally, the electrode pair includes two electrodes with opposite polarities, and each of the electrodes is a structure formed on the surface of the inner balloon by electroplating, or each of the electrodes is a flexible circuit.

[0018] Optionally, there are multiple electrode pairs, and the multiple electrode pairs are arranged along the axial and circumferential directions of the expanded inner balloon.

[0019] Optionally, each of the electrode pairs includes a positive electrode and a negative electrode, the positive electrode and the negative electrode in each electrode pair are arranged along the axial direction of the expanded inner balloon, and the positive electrode and the negative electrode of two adjacent electrode pairs are connected by a wire.

[0020] Optionally, the material of the inner balloon is a compliant material or a non-compliant material.

[0021] Optionally, the catheter body includes an inner tube and an outer tube, the inner tube is arranged in the outer tube and extends beyond the distal end of the outer tube; the proximal end and the distal end of the inner balloon are respectively fixedly connected to the inner tube; the proximal end of the outer balloon is fixedly connected to the outer tube, and the distal end is fixedly connected to the inner tube; an outer balloon liquid cavity is formed between the inner tube and the outer tube, and the outer balloon liquid cavity is connected to the outer balloon; an inner balloon liquid cavity is arranged in the inner tube, and the inner balloon liquid cavity is connected to the inner balloon.

[0022] Optionally, the catheter body also includes a handle located at the proximal end, and the proximal ends of the inner tube and the outer tube are connected to the handle. An outer balloon liquid inlet and an inner balloon liquid inlet are provided on the handle, and the outer balloon liquid inlet is connected to the outer balloon liquid cavity, and the inner balloon liquid inlet is connected to the inner balloon liquid cavity.

[0023] Optionally, the diameter of the outer balloon after expansion is 0.75 mm to 30.0 mm, and the axial length of the outer balloon after expansion is 3 mm to 300 mm.

[0024] Optionally, the diameter of the inner balloon after expansion is 0.5 mm to 29.0 mm, and the axial length of the inner balloon after expansion is 3 mm to 300 mm.

[0025] The electrode balloon catheter sets the electrode pair on the inner balloon, and the position of the electrode pair can be adjusted by expanding the inner balloon, thereby adjusting the position of the electrode pair relative to the target lesion, thereby adjusting the propagation distance of the shock wave and the energy of the shock wave acting on the target lesion position, improving the lesion treatment efficiency, thereby reducing the operation time and increasing the service life of the electrode. At the same time, the electrode balloon catheter uses the balloon to adjust the position of the electrode pair, has a simple structure, and is convenient for surgical operation.

[0026] If the electrode pair is arranged on the outer surface of the inner balloon, the electrode can directly contact the conductive medium, the directionality of the shock wave transmission is better, and the shock wave can be effectively emitted outward toward the outer surface of the outer balloon, and the lesion treatment efficiency is higher. If the electrode pair is arranged on the inner surface of the inner balloon, a double-layer balloon protection can be formed for the electrode, which is safer.

[0027] The electrode balloon catheter can achieve a fixed insulation distance or a variable insulation distance between the positive electrode and the negative electrode in the electrode pair, making the lesion treatment method more flexible. For example, when the material of the inner balloon is a compliant material, the insulation distance can change with the expansion of the inner balloon, thereby flexibly adjusting the energy intensity released by the pulsed electric field and improving the efficiency of lesion treatment.

[0028] The electrode balloon catheter can directly form electrodes on the surface of the inner balloon by electroplating, which reduces the difficulty of electrode assembly, reduces the electrode thickness, and reduces the outer diameter of the catheter. In other words, the electrode is made of a flexible circuit to improve the flexibility of the electrode, make the electrode easy to fold, and reduce the outer diameter of the catheter.

[0029] The above-mentioned electrode balloon catheter can adopt multiple electrode pairs, and the multiple electrode pairs are arranged along the axial and circumferential directions of the inner balloon after expansion. At this time, in order to reduce the passing outer diameter of the balloon, it is preferred that the multiple electrode pairs are arranged in series through wires, that is, the positive electrode and the negative electrode in each electrode pair are arranged along the axial direction of the inner balloon after expansion, and the positive electrode and the negative electrode of two adjacent electrode pairs are connected by wires. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic structural diagram of an electrode balloon catheter according to a preferred embodiment of the present invention, wherein the outer balloon has been expanded and the inner balloon has not been expanded;

[0031] Figure 2 for Figure 1 A partial enlarged view of the middle electrode balloon catheter;

[0032] Figure 3 It is a cross-sectional schematic diagram of an electrode balloon catheter according to a preferred embodiment of the present invention, wherein the outer balloon has been expanded and the inner balloon has not been expanded;

[0033] Figure 4 It is a schematic structural diagram of an electrode balloon catheter according to a preferred embodiment of the present invention, wherein both the outer balloon and the inner balloon have been expanded;

[0034] Figure 5 for Figure 4 A partial enlarged view of the middle electrode balloon catheter;

[0035] Figure 6 It is a cross-sectional schematic diagram of an electrode balloon catheter according to a preferred embodiment of the present invention, wherein both the outer balloon and the inner balloon have been expanded;

[0036] Figure 7 This is an expanded view of the inner balloon after expansion according to a preferred embodiment of the present invention.

[0037] Description of reference numerals:

[0038] 1-catheter body; 11-inner tube; 111-outer balloon fluid passage cavity; 112-inner balloon fluid passage cavity; 12-outer tube; 2-outer balloon; 22-conical section; 21-straight section; 3-inner balloon; 4-electrode pair; 5-wire; 6-handle; 61-outer balloon fluid passage inlet; 62-inner balloon fluid passage inlet; 63-energy interface. DETAILED DESCRIPTION

[0039] In order to make the content of the present invention more clear and easy to understand, the present invention is further described below in conjunction with the drawings and embodiments of the specification. However, it can be understood that the present invention is not limited to the specific embodiments described below, and general replacements known to those skilled in the art are also covered within the scope of protection of the present invention. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0040] It should be understood that in the following description, references to "above" and "below" various components may be made based on the accompanying drawings. Spatial terms such as "under...", "below...", "below", "above", etc., are intended to easily describe the positional relationship between one component and another component shown in the accompanying drawings. In addition to the orientation shown in the drawings, spatial relationship terms may include various different orientations of the device in use or operation. The device may be positioned in other ways, such as rotated 90 degrees or in other orientations, and the spatial relationship descriptions used herein are interpreted accordingly. It should also be understood that in the following description, "connection" includes direct connection between systems, components, and parts, and also includes connection between systems, components, and parts through a medium, that is, indirect connection. It should be understood that in the following description, "first" and "second" are not limitations on the number of components, but are only used to distinguish one component from another.

[0041] In this article, "proximal end" and "distal end" refer to the relative orientation, relative position and direction of elements or actions relative to each other from the perspective of a doctor using the electrode balloon catheter. Although "proximal end" and "distal end" are not restrictive, "proximal end" generally refers to the end of the electrode balloon catheter that is away from the patient and closer to the operator during normal operation. Correspondingly, "distal end" generally refers to the end of the electrode balloon catheter that is closer to the patient and away from the operator during normal operation. In this article, "axial" refers to the direction parallel to the axis; "radial" refers to the direction perpendicular to the axis; "circumferential" refers to the direction around the axis. In this article, the meaning of "multiple" generally refers to two or more.

[0042] The electrode balloon catheter proposed by the present invention is described in detail below in conjunction with the accompanying drawings and preferred embodiments.

[0043] See also Figure 1-2The present invention provides an electrode balloon catheter, which includes a catheter body 1, an outer balloon 2, an inner balloon 3 and an electrode pair 4. The outer balloon 2 and the inner balloon 3 are both arranged at the end of the catheter body 1. The inner balloon 3 is arranged in the outer balloon 2 and is used to load the electrode pair 4. The interior of the outer balloon 2 is used to store a conductive medium, that is, the space between the outer balloon 2 and the inner balloon 3 is used to store a conductive medium, and the conductive medium is used to transmit shock waves. At least one electrode pair 4 is arranged on the inner balloon 3, such as on the inner surface or outer surface of the inner balloon 3. If the electrode pair 4 is arranged on the outer surface of the inner balloon 3, the electrode can directly contact the conductive medium, the directionality of the shock wave transmission is better, and the shock wave can be effectively emitted outward in the direction of the outer surface of the outer balloon 2; and if the electrode pair 4 is arranged on the inner surface of the inner balloon 3, a double-layer balloon protection can be formed for the electrode, which is safer.

[0044] Further, the number of electrode pairs 4 is multiple, some electrode pairs 4 can be arranged on the inner surface of the inner balloon 3, some electrode pairs 4 can be arranged on the outer surface of the inner balloon 3, or all electrode pairs 4 are arranged on the inner surface or outer surface of the inner balloon 3. It should be understood that the electrode pairs 4 are used to receive high-voltage pulses to generate shock waves, and each electrode pair 4 includes a positive electrode and a negative electrode, the positive electrode and the negative electrode are insulated from each other, and the insulation distance between the positive electrode and the negative electrode is configured within a preset range. It should be understood that when the electrode pair 4 generates a pulsed electric field, since the pulsed electric field is released between the positive electrode and the negative electrode as a positive and negative electrode signal, at this time, if the insulation distance between the electrodes is too small, it is easy to generate electric sparks and low-temperature plasma effects, and if the insulation distance is too large, it will affect the electric field strength. For this reason, the insulation distance between the two electrodes is designed to be a preset range, which can ensure the electric field energy intensity and does not generate ionization, ensuring the energy and safety acting on the lesion. It should also be understood that the insulation distance refers to the distance between the positive electrode and the negative electrode when the inner balloon 3 is in a contracted or expanded state. The insulation distance will change with the contraction or expansion of the inner balloon 3, but no matter how it changes, it is necessary to ensure that the insulation distance is within the preset range.

[0045] When the electrode balloon catheter of the present invention is used, the outer balloon 2 is expanded to adhere to and expand the vascular calcification focus, and the outer balloon 2 covers the inner balloon 3 and the electrode pair 4 to prevent the electrode from directly contacting the human body, and also adjusts the position of the electrode pair 4 relative to the target lesion by adjusting the expansion diameter of the inner balloon 3, thereby adjusting the propagation distance of the shock wave and the energy of the shock wave acting on the target lesion position to adapt to more treatment scenarios. In particular, when the inner balloon 3 is expanded, the electrode pair 4 is closer to the position of the target lesion, the propagation distance of the shock wave is reduced, the intensity of the shock wave transmitted to the target lesion position is enhanced, the energy of the shock wave acting on the target lesion position is increased, and the efficiency of breaking the calcification focus is increased, thereby reducing the operation time, and also reducing the number of shock wave releases, and increasing the service life of the electrode. At the same time, the effect of directional treatment of asymmetric calcification focus can be achieved.

[0046] Figures 1 to 3 The state of the expanded outer balloon 2 and the unexpanded inner balloon 3 is shown. Figure 1 to Figure 3 As shown, when the outer balloon 2 is fully expanded, it can adhere to and expand the targeted lesion, and when the inner balloon 3 contracts, the electrode pair 4 on the surface of the inner balloon 3 is far away from the outer balloon 2. At this time, the shock wave released by the electrode pair 4 is transmitted to the outer balloon 2 and the surrounding blood vessel wall through the conductive medium in the outer balloon 2, thereby acting on the calcification. At this time, the shock wave propagation distance is long, and the shock wave energy density acting on the calcification is relatively low.

[0047] Figures 4 to 6 The state of the expanded outer balloon 2 and the expanded inner balloon 3 is shown. Figures 4 to 6 As shown, when the inner balloon 3 is also expanded, the electrode pair 4 on the surface of the inner balloon 3 is closer to the surface of the outer balloon 2 and the lesion tissue at the corresponding position, that is, the distance between the electrode pair 4 and the surface of the outer balloon 2 is smaller, so the shock wave propagation distance is reduced, thereby reducing the energy loss caused by the shock wave propagation distance, making the shock wave more effective on the corresponding lesion position and improving the crushing efficiency. It should also be understood that the expansion degree of the inner balloon 3 is set according to the treatment needs. The inner balloon 3 can be fully expanded to the maximum diameter or less than the diameter after full expansion. Since the outer balloon 2 needs to expand in contact with the blood vessel wall, the outer balloon 2 is usually in a fully expanded state.

[0048] Therefore, the electrode balloon catheter of the present invention replaces the immovable electrode carrier in the prior art with an expandable and contractible inner balloon 3, so that the electrode can realize free movement of position in the outer balloon 2, improve the ability to crush the calcification focus, reduce the operation time, reduce the risk of ischemic complications, and reduce the number of shock wave releases, thereby improving the service life of the electrode. Moreover, when the electrode balloon catheter of the present invention treats asymmetric calcification, the electrode pair 4 is arranged on the surface of the inner balloon relative to the asymmetric lesion. After the inner balloon is expanded, the electrode will be closer to the lesion, thereby achieving the purpose of directional treatment of asymmetric calcification. In addition, since the number of shock wave releases can be reduced, the electrode material selection and size design can be more relaxed, which indirectly reduces the outer diameter of the electrode balloon catheter and reduces the manufacturing cost of the product. In addition, during the transportation process, the inner and outer balloons are mainly transported in a folded manner, that is, the inner balloon 3 and the outer balloon 2 are both folded and pressed on the catheter body 1, and the electrode on the inner balloon 3 can be folded with the inner balloon 3, such as a patch-type electrode with a very small size or an electrode of a flexible circuit, which is convenient to fold, and the folded balloon has a small outer diameter. Flexible circuits are small in size, light in weight, thin in thickness, soft and bendable.

[0049] The number and arrangement of the electrode pairs 4 are set according to the actual treatment needs, as long as the shock waves released by the electrodes can be well propagated to the vascular lesions to achieve a better treatment effect. In this embodiment, a plurality of electrode pairs 4 are provided on the inner balloon 3, and the plurality of electrode pairs 4 are distributed along the axial and / or circumferential direction of the inner balloon 3. The number and position of the electrode pairs 4 distributed in the circumferential direction determine the diameter range of the calcification lesion that the shock wave acts on in the circumferential direction, and the number and position of the electrode pairs 4 distributed in the axial direction determine the length of the calcification lesion that the shock wave acts on in the axial direction.

[0050] exist Figures 1 to 6 9 electrode pairs 4 are shown, and the 9 electrode pairs 4 are arranged both along the axial direction of the inner balloon 3 and along the circumferential direction of the inner balloon 3. Of course, the positive electrode and the negative electrode in each electrode pair 4 are insulated from each other, and the preset range of the insulation distance between the positive electrode and the negative electrode in the electrode pair 4 is preferably 0.01 mm to 10 mm, and more preferably 0.1 mm to 2.0 mm.

[0051] exist Figure 7 Six electrode pairs 4 are shown, and the six electrode pairs 4 are arranged both along the axial direction of the inner balloon 3 and along the circumferential direction of the inner balloon 3. Of course, the number of electrode pairs 4 is not limited to 6 or 9 as exemplified here, and multiple electrode pairs 4 can be arranged uniformly or non-uniformly in the axial direction, and can also be arranged uniformly or non-uniformly in the circumferential direction.

[0052] In some embodiments, the insulation distance between the positive electrode and the negative electrode in the electrode pair 4 is fixed to ensure the stability of each energy release. Therefore, even if the propagation distance changes, the shock wave energy released by each electrode pair 4 remains unchanged. At this time, the insulation distance does not change with the shape and size of the inner balloon 3. Further, in order to achieve the fixed insulation distance, the positive electrode and the negative electrode in the electrode pair 4 are rigidly connected to form a whole, and the rigidly connected whole is fixed on the inner balloon 3. "Rigid connection" means that between the positive electrode and the negative electrode, when one electrode is displaced or subjected to force, the other electrode connected to it does not displace or deform relative to the first electrode.

[0053] In some embodiments, the insulation distance between the positive electrode and the negative electrode in the electrode pair 4 can be changed, so that the intensity of energy release can be adjusted and the flexibility of lesion treatment can be increased. Therefore, as the propagation distance changes, the shock wave energy released by each electrode pair 4 will also change, and the shock wave energy can be enhanced or reduced, so the insulation distance changes with the shape and size of the inner balloon 3. When the insulation distance is variable, the insulation distance can be ensured to be within a preset range by regulating the expansion diameter of the inner balloon 3. Further, in order to achieve the variable insulation distance, the positive electrode and the negative electrode in the electrode pair 4 are flexibly connected to form a whole, and the flexibly connected whole is fixed on the inner balloon 3. "Flexible connection" means that when one electrode is displaced or subjected to force, the other electrode connected thereto can be displaced or relatively deformed relative to the first electrode. Or in order to achieve the variable insulation distance, the positive electrode and the negative electrode in the electrode pair 4 are not connected to each other but are independently fixed on the inner balloon 3, and as the inner balloon 3 expands, the positive electrode and the negative electrode can move freely and independently.

[0054] The present application does not limit the way in which the electrode pair 4 is fixed to the inner balloon 3, such as by glue bonding, welding or electroplating. In order to reduce the difficulty of electrode assembly, as well as reduce the electrode thickness and rigidity, it is preferred to form the electrode directly on the surface of the inner balloon 3 by electroplating, or to use a flexible circuit to make the electrode and bond it to the inner balloon 3. In addition to reducing the difficulty of assembly, the electrode made by the electroplating process can also reduce the electrode thickness and reduce the outer diameter of the electrode balloon catheter. The electrode made of the flexible circuit is easy to fold and can also reduce the outer diameter of the electrode balloon catheter.

[0055] like Figure 2 and Figure 5As shown, the electrode pair 4 also needs to be connected to a wire 5, wherein the positive electrode in the electrode pair 4 is connected to the positive pole of the power supply of the high-voltage pulse generator through the wire 5, and the negative electrode in the electrode pair 4 is connected to the negative pole of the power supply of the high-voltage pulse generator through the wire 5. The high-voltage pulse generator is used to provide the pulses required for the electrode pair 4 to generate shock waves. Generally, the high-voltage pulse generator releases current through the switch of the circuit to control the frequency and number of shock waves released by the electrode.

[0056] The present application does not require the type of electrode, such as a patch-type electrode or a ring electrode. "Ring electrode" means a ring-shaped electrode that is sleeved on the inner balloon 3; "patch-type electrode" means an electrode sheet that is basically flat or in a small arc shape and is attached to the inner balloon 3. In this embodiment, the electrode is a patch-type electrode, which is based on the principle of tip discharge, has a high energy density, and can enhance the liquid-electric effect.

[0057] In addition, there is no specific limitation on the arrangement of the multiple electrode pairs 4 on the inner balloon 3, and they can be arranged independently of each other, or arranged in series with each other, or arranged in parallel with each other.

[0058] exist Figure 7 4 shows the arrangement of six electrode pairs 4 in series. Taking six electrode pairs 4 as an example, the six electrode pairs 4 are arranged in both the axial and circumferential directions of the expanded inner balloon 3, such as two rows in the circumferential direction and three columns in the axial direction. The six electrode pairs 4 are arranged in series through the wires 5. More specifically, the negative electrode ( Figure 7 "-" indicates the negative electrode) and the positive electrode ( Figure 7 The positive electrode is represented by "+" in the figure) and connected by a wire 5 to finally form a series circuit, wherein the positive electrode of the series circuit is connected to the positive electrode of the power supply of the high-voltage pulse generator, and the negative electrode of the series circuit is connected to the negative electrode of the power supply of the high-voltage pulse generator. It should be understood that Figure 7The state after the inner balloon 3 is expanded and then unfolded in a plane is shown. In the plane unfolding diagram of the expanded inner balloon 3, six electrode pairs 4 are connected in series through wires 5, and the positive and negative electrodes of the final series circuit are connected to the high-voltage pulse generator through wires 5. At this time, the number of wires 5 connected between the electrode pairs 4 and the high-voltage pulse generator is small, which reduces the number of wires 5, and is convenient for reducing the size of the catheter and reducing the outer diameter. Of course, in other embodiments, the six electrode pairs 4 can also be arranged in parallel through wires 5. At this time, the positive electrodes and positive electrodes of adjacent electrode pairs 4 are connected through wires 5, and the negative electrodes and negative electrodes of adjacent electrode pairs 4 are connected through wires 5, and finally a parallel circuit is formed, and the positive electrode of the parallel circuit is connected to the positive electrode of the power supply of the high-voltage pulse generator, and the negative electrode of the parallel circuit is connected to the negative electrode of the power supply of the high-voltage pulse generator. This method can also reduce the number of wires. In other embodiments, each electrode pair 4 may not be connected through wires 5. At this time, each electrode pair 4 is independent of each other and connected to the high-voltage pulse generator respectively, that is, the positive electrode is connected to the positive electrode of the power supply of the high-voltage pulse generator through wires 5, and the negative electrode is connected to the negative electrode of the power supply of the high-voltage pulse generator through wires 5.

[0059] The present application does not limit the material of the outer balloon 2. The material of the outer balloon 2 can be a compliant material or a non-compliant material, preferably a compliant material. The compliant outer balloon 2 has good pressure resistance and can dilate blood vessels better. Moreover, the folded size of the compliant balloon is smaller, making it easier to pass through the narrow calcified lesions and achieve dilation treatment of stenotic lesions. The compliant material of the outer balloon 2 can be selected from materials such as PU (polyurethane), PE (polyethylene) or silica gel. The non-compliant material of the outer balloon 2 can be selected from materials such as PET and nylon.

[0060] Figure 2 and Figure 5 The state of the outer balloon 2 after expansion is shown. After expansion, the outer balloon 2 has a straight section 21 and a tapered section 22 connected to both ends of the straight section 21. In actual work, the straight section 21 is mainly used to expand the blood vessel, so the straight section 21 is an effective working section. The diameter and axial length of the outer balloon 2 after expansion are set according to the size and range of the lesion location actually treated. Optionally, the diameter of the outer balloon 2 after expansion is 0.75mm~30.0mm, preferably 2.0mm~20mm, and the axial length of the outer balloon 2 after expansion is 3mm~300mm, preferably 4mm~250mm.

[0061] The present application also does not make any requirements on the material of the inner balloon 3. The material of the inner balloon 3 can be a compliant material or a non-compliant material. The compliant material of the inner balloon 3 can be the same as that of the outer balloon 2, such as selected from materials such as PU (polyurethane), PE (polyethylene) or silicone. The non-compliant material of the inner balloon 3 can also be the same as that of the outer balloon 2, such as selected from materials such as PET, nylon, etc. When the material of the inner balloon 3 is selected as a non-compliant material, if the two electrodes in the electrode pair 4 are flexibly connected, even if the two electrodes have relative displacement, the displacement is very small, so the change in the insulation distance is very small and has little effect on the release of the shock wave. At this time, it can be understood that the insulation distance remains unchanged. When the material of the inner balloon 3 is selected as a compliant material, if the two electrodes in the electrode pair 4 are flexibly connected, the two electrodes can produce a large relative displacement, thereby changing the insulation distance. It should be understood that when the material of the inner balloon 3 is a non-compliant material, the two electrodes in the electrode pair 4 can be considered to have an unchanged insulation distance regardless of whether they are rigidly connected, flexibly connected, or not connected; and when the material of the inner balloon 3 is a compliant material, if the insulation distance is to be ensured to be unchanged, the two electrodes in the electrode pair 4 need to be rigidly connected. Similarly, the diameter and axial length of the inner balloon 3 after expansion are also set according to the size and range of the lesion location actually treated. Optionally, the diameter of the inner balloon 3 after expansion is 0.5mm to 29.0mm, preferably 0.7mm to 28.0mm, and the axial length of the inner balloon 3 after expansion is 3mm to 300mm, preferably 6mm to 180mm. Of course, the diameter of the outer balloon 2 after expansion is greater than the diameter of the inner balloon 3 after expansion, and the axial length of the outer balloon 2 after expansion is greater than the axial length of the inner balloon 3 after expansion.

[0062] In an illustrative embodiment, the insulation distance between the positive and negative electrodes in the electrode pair 4 is 0.7 mm, the maximum diameter of the inner balloon 3 after expansion is 2.5 mm, and the maximum diameter of the outer balloon 2 after expansion is 3.0 mm.

[0063] Furthermore, the catheter body 1 has an outer balloon liquid passage cavity 111 and an inner balloon liquid passage cavity 112. Figure 2 The outer balloon liquid cavity 111 is connected to the outer balloon 2, so that a fluid (such as a conductive medium) can be transported to the outer balloon 2 through the outer balloon liquid cavity 111 to achieve expansion of the outer balloon 2, and the fluid can be withdrawn through the outer balloon liquid cavity 111 to achieve contraction of the outer balloon 2. The inner balloon liquid cavity 112 is connected to the inner balloon 3, so that a fluid can be transported to the inner balloon 3 through the inner balloon liquid cavity 112 to achieve expansion of the inner balloon 3, and the fluid can be withdrawn through the inner balloon liquid cavity 112 to achieve contraction of the inner balloon 3.

[0064] In this embodiment, the catheter body 1 includes an inner tube 11 and an outer tube 12, the inner tube 11 is inserted into the outer tube 12, and the distal end of the inner tube 11 extends beyond the outer tube 12. The proximal end of the outer balloon 2 is fixedly connected to the outer tube 12, and the distal end is fixedly connected to the inner tube 11. The proximal end and the distal end of the inner balloon 3 are both fixedly connected to the inner tube 11. Further, the outer balloon liquid passage cavity 111 is arranged between the inner tube 11 and the outer tube 12, and the inner balloon liquid passage cavity 112 is arranged in the inner tube 11. The inner tube 11 can be a single-lumen tube or a multi-lumen tube, preferably a multi-lumen tube. For example, a guidewire cavity, a guide wire cavity and an inner balloon liquid passage cavity 112 or other cavities are arranged in the inner tube 11. The guidewire cavity is used to thread a guidewire; the guide wire cavity is used to lay the guide wire 5. Further, the catheter body 1 also includes a handle 6 located at the proximal end, and the proximal ends of the inner tube 11 and the outer tube 12 are connected to the handle 6. The handle 6 is provided with an outer balloon liquid inlet 61 and an inner balloon liquid inlet 62. The outer balloon liquid inlet 51 is connected to the outer balloon liquid cavity 111, and the inner balloon liquid inlet 62 is connected to the inner balloon liquid cavity 112. The outer balloon liquid inlet 51 and the inner balloon liquid inlet 62 are both connected to an external liquid supply device. In addition, the handle 6 may also include an energy interface 63, and the wire 5 is connected to the high-voltage pulse generator through the energy interface 63.

[0065] Furthermore, a developing structure is provided at the distal end of the inner tube 11, and the developing structure is provided inside the inner balloon 3. Usually, a developing ring is provided at the proximal end and the distal end of the inner balloon respectively, so as to determine the positions of the inner balloon and the outer balloon by X-ray development.

[0066] Furthermore, the electrode balloon catheter also includes the high-voltage pulse generator. The high-voltage pulse generator is arranged at the proximal end of the catheter body 1. After receiving the high-voltage pulse sent to it by the high-voltage pulse generator, the electrode pair 4 emits an arc, vaporizes the surrounding conductive medium to form steam bubbles, and generates shock waves after the steam bubbles expand and burst. The shock waves are transmitted to the outer balloon 2 and the surrounding blood vessel walls through the conductive medium inside the outer balloon 2, thereby acting on the calcification. Repeated pulses can crush the calcification without damaging the blood vessel wall and the surrounding soft tissue. The conductive medium can not only conduct electricity, but also fill the outer balloon 2 to expand the outer balloon 2. The present application does not limit the specific type of conductive medium. The conductive medium can be physiological saline, conductive hydrogel, antioxidant conductive liquid, contrast fluid, etc. The antioxidant conductive liquid can prevent the conductive medium from damaging the electrode to improve the durability of the electrode. In this solution, after the outer balloon 2 reaches the lesion location, a conductive medium can be poured into the outer balloon 2. In this case, during the transportation process, it is helpful to empty the air in the outer balloon 2, so that the outer balloon 2 can shrink and adhere to the outer surface of the catheter before being filled, and the outer diameter of the balloon is smaller.

[0067] Next, the working mode of the electrode balloon catheter of this embodiment will be further described.

[0068] First, after intervention in the blood vessel, the electrode balloon catheter passes through the narrow lesion through a smaller outer diameter and reaches the target lesion (i.e., the calcification area). After reaching the target lesion, a conductive medium is injected into the outer balloon 2 through the outer balloon liquid cavity 111 connected to the outer balloon 2. By controlling the amount and pressure of the injected conductive medium, the expansion diameter of the outer balloon 2 is controlled until the outer balloon 2 completely fits the target lesion. Preferably, the injected conductive medium has X-ray development properties, and the operator can observe the expansion of the outer balloon 2 and the fit with the target lesion through X-rays. After the expansion of the outer balloon 2 is completed, liquid is injected into the inner balloon 3 through the inner balloon liquid cavity 112 connected to the inner balloon 3, and the liquid is preferably a contrast agent. By controlling the volume of the injected liquid, the expansion diameter of the inner balloon 3 is controlled until the electrode pair 4 thereon reaches a suitable position. After the expansion of the inner balloon 3 is completed, a high-voltage pulse generator is used to transmit a high-voltage pulse to the electrode pair 4 via the wire 5. After the high-energy electrons gather at the electrode, they break through the conductive medium between the two electrodes in the electrode pair 4, causing a hydroelectric effect, and the resulting shock wave acts on the target lesion to destroy the target calcified structure. At the same time, the expansion force generated by the outer balloon 2 through the pressure provided by the outer balloon liquid cavity 111 and the outer balloon 2 completes the expansion of the caliber of the target lesion. In this way, the electrode balloon catheter can be used to pre-expand the narrow lesion area, establish a sufficient vascular lumen size, and assist in the subsequent passage of medical devices with relatively large outer diameters to reach the target lesion, such as stent delivery devices, drug balloons, etc.

[0069] According to the technical solution provided in the embodiment of the present invention, the electrode balloon catheter of the present invention can adjust the distance between the electrode and the diseased tissue through the inner balloon, reduce the energy loss during the shock wave transmission process, improve the ability to break up calcification, reduce the operation time and the number of shock wave releases, increase the service life of the electrode, and reduce the risk of complications. Therefore, the electrode balloon catheter of the present invention can change the distance between the electrode and the diseased tissue by adjusting the expansion degree of the inner balloon, enhance the treatment efficiency of the lesion, and for asymmetric eccentric calcification foci, the electrode balloon catheter can achieve directional treatment, so that the application scenarios of the electrode balloon catheter are wider and the treatment ability is stronger. It should be understood that the electrode balloon catheter of the present invention is particularly suitable for interventional treatment of coronary arteries, and of course it can also be applied to interventional treatment of other blood vessels.

[0070] It should be understood that the above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any equivalent changes, modifications and evolutions made by technicians familiar with this profession without departing from the spirit and scope of the present invention using the technical content disclosed above are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. An electrode balloon catheter, characterized in that: include: Catheter body; An outer balloon, disposed at the end of the catheter body and used to store a conductive medium; an inner balloon, disposed at the end of the catheter body and located inside the outer balloon; and, An electrode pair, for receiving a high voltage pulse to generate a shock wave, and at least one of the electrode pairs is disposed on the outer surface of the inner balloon; the electrode pair comprises a positive electrode and a negative electrode, the positive electrode and the negative electrode are insulated from each other, and the insulation distance between the positive electrode and the negative electrode is fixed or variable; the insulation distance between the positive electrode and the negative electrode is configured to be within a preset range; The outer balloon is expanded to fit the target object, and the inner balloon drives the electrode pair away from or close to the target object by expansion, and the position of the electrode pair relative to the target lesion is regulated by adjusting the expansion diameter of the inner balloon.

2. The electrode balloon catheter according to claim 1, characterized in that: The preset range is 0.01mm~10mm.

3. The electrode balloon catheter according to claim 1, characterized in that: The electrode pair includes a positive electrode and a negative electrode, the positive electrode and the negative electrode are insulated from each other, and the positive electrode and the negative electrode are rigidly connected or flexibly connected or not connected.

4. The electrode balloon catheter according to claim 1, characterized in that: The electrode pair includes two electrodes with opposite polarities, and each of the electrodes is a structure formed on the surface of the inner balloon by electroplating, or each of the electrodes is a flexible circuit.

5. The electrode balloon catheter according to claim 1, characterized in that: There are multiple electrode pairs, and the multiple electrode pairs are arranged along the axial direction and circumferential direction of the expanded inner balloon.

6. The electrode balloon catheter according to claim 5, characterized in that: Each electrode pair includes a positive electrode and a negative electrode. The positive electrode and the negative electrode in each electrode pair are arranged along the axial direction of the expanded inner balloon. The positive electrodes and negative electrodes of two adjacent electrode pairs are connected by wires.

7. The electrode balloon catheter according to claim 1, characterized in that: The material of the inner balloon is a compliant material or a non-compliant material.

8. The electrode balloon catheter according to claim 1, characterized in that: The catheter body includes an inner tube and an outer tube, the inner tube is arranged in the outer tube and extends beyond the distal end of the outer tube; the proximal end and the distal end of the inner balloon are fixedly connected to the inner tube respectively; the proximal end of the outer balloon is fixedly connected to the outer tube, and the distal end is fixedly connected to the inner tube; an outer balloon liquid cavity is formed between the inner tube and the outer tube, and the outer balloon liquid cavity is connected to the outer balloon; an inner balloon liquid cavity is arranged in the inner tube, and the inner balloon liquid cavity is connected to the inner balloon.

9. The electrode balloon catheter according to claim 8, characterized in that: The catheter body also includes a handle located at the proximal end, and the proximal ends of the inner tube and the outer tube are both connected to the handle. The handle is provided with an outer balloon liquid inlet and an inner balloon liquid inlet, and the outer balloon liquid inlet is connected to the outer balloon liquid cavity, and the inner balloon liquid inlet is connected to the inner balloon liquid cavity.

10. The electrode balloon catheter according to claim 1, characterized in that: The diameter of the outer balloon after expansion is 0.75 mm to 30.0 mm, and the axial length of the outer balloon after expansion is 3 mm to 300 mm.

11. The electrode balloon catheter according to claim 1, characterized in that: The diameter of the inner balloon after expansion is 0.5 mm to 29.0 mm, and the axial length of the inner balloon after expansion is 3 mm to 300 mm.

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