Multi-electrode shock-wave electrode structure, and shock-wave balloon catheter

Abstract

Provided in the present invention are a multi-electrode shock-wave electrode structure, and a shock-wave balloon catheter. The multi-electrode shock-wave electrode structure comprises at least two discharge units, wherein each discharge unit comprises an emitting electrode and a corresponding intermediate electrode that are spaced apart and extend in the same direction, and the emitting electrodes are sleeved in a one-to-one correspondence and spaced apart in the intermediate electrodes; all the intermediate electrodes are electrically connected to each other; and when discharge end faces of all the intermediate electrodes and discharge end faces of all the emitting electrodes are all located in a conductive fluid, and an electric-potential difference is formed between the emitting electrodes of any two discharge units, shock waves are simultaneously induced between the discharge end faces of the emitting electrodes and the discharge end faces of the corresponding intermediate electrodes in the two discharge units. The shock-wave balloon catheter comprises the multi-electrode shock-wave electrode structure. The present invention solves the problem of damage caused by a mechanical impact force while forming substantial shock-wave energy from a single effective discharge breakdown, and has a relatively long service life.

Description

Multi-head shockwave electrode structure and shockwave balloon catheter TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, in particular to a multi-head shockwave electrode structure and a shockwave balloon catheter. BACKGROUND

[0002] Electrohydraulic shockwave is generated in an electrode in a conductive fluid. High-voltage pulse current is applied to two electrodes with a potential difference in the conductive fluid, and a high-temperature arc is generated between the two closest points on the two electrodes with a potential difference. The high-temperature arc generates a large amount of heat and a strong mechanical impact force while forming a shockwave. The heat of the high-temperature arc melts the two positions on the electrode where the shockwave is generated and forms ablation.

[0003] The current shockwave catheter is used to loosen or create cracks in calcified lesion tissue in coronary or peripheral blood vessels, and then expand by inflating the balloon to relieve the degree of stenosis of the blood vessel or facilitate subsequent treatment. The shockwave catheter has been put into the market and its safety and effectiveness have been fully verified. However, the existing shockwave balloon catheter cannot treat hardened tissues such as calcified lesion tissues in parts that cannot or are not convenient to expand, such as the mitral valve and aortic valve of the human body. SUMMARY

[0004] Therefore, the present application provides a multi-head shockwave electrode structure and a shockwave balloon catheter, which aims to release shockwaves by multiple discharge units at the same time, utilize the superposition of shockwave energy to achieve a larger shockwave energy, and solve the problem of damage to the electrode structure caused by the larger mechanical impact force formed by the larger shockwave energy, thereby solving the problem that the existing technology cannot use shockwave energy to treat hardened tissues in parts that cannot or are not convenient to expand, achieving the purpose of treating hardened tissues in parts that cannot or are not convenient to expand without expansion and only using shockwave energy, and softening these hardened tissues and restoring part of the tissue function.

[0005] The present application provides a multi-head shockwave electrode structure, which comprises at least two discharge units; each discharge unit comprises one emitting electrode and one corresponding intermediate electrode which are arranged at intervals and have the same extension direction, and the emitting electrode is correspondingly sleeved in the intermediate electrode; all intermediate electrodes are electrically connected to each other; when the discharge end faces of all intermediate electrodes and the discharge end faces of all emitting electrodes are located in a conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, the discharge end faces of the emitting electrodes and the discharge end faces of the corresponding intermediate electrodes of the two discharge units simultaneously induce shockwaves.

[0006] The application further provides a shock wave balloon catheter, comprising the multi-head shock wave electrode structure, the tube body and the inflation element capable of filling with conductive fluid as described above; the inflation element is sealingly connected to the distal end of the tube body, the discharge end faces of all the emission electrodes and the discharge end faces of all the intermediate electrodes of the multi-head shock wave electrode structure are located in the inflation element; when the inflation element is filled with the conductive fluid and a potential difference is formed between any two emission electrodes of the multi-head shock wave electrode structure, the discharge end faces of the two emission electrodes forming the potential difference and the discharge end faces of the respective corresponding intermediate electrodes simultaneously initiate shock waves.

[0007] Compared with the prior art, the above at least one technical solution adopted by the embodiments of the present application can achieve the beneficial effects at least including: while realizing single effective discharge breakdown to form larger shock wave energy, the problem of damage of larger mechanical impact force accompanying larger shock wave energy to the electrode structure is solved, thereby solving the problem that the prior art cannot use shock wave energy to treat hardened tissues at sites which cannot or are inconvenient to expand, achieving the purpose of treating hardened tissues at sites which cannot or are inconvenient to expand by using only shock wave energy without the aid of expansion, so as to soften the hardened tissues and restore part of the tissue function. Meanwhile, the multi-head shock wave electrode structure of the present application also has more effective shock wave initiation times and a longer service life. BRIEF DESCRIPTION OF DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly introduced as follows. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative effort on the basis of these drawings.

[0009] Fig. 1 is a top view structural schematic diagram of a first specific embodiment of the multi-head shock wave electrode structure of the present application;

[0010] Fig. 2 is another top view structural schematic diagram of the first specific embodiment of the multi-head shock wave electrode structure of the present application;

[0011] Fig. 3 is a three-dimensional structural schematic diagram of a second specific embodiment of the multi-head shock wave electrode structure of the present application;

[0012] Fig. 4 is a top view structural schematic diagram of the second specific embodiment of the multi-head shock wave electrode structure of the present application;

[0013] Fig. 5 is a three-dimensional structural schematic diagram of a third specific embodiment of the multi-head shock wave electrode structure of the present application;

[0014] Fig. 6 is a three-dimensional structural schematic diagram of a fourth specific embodiment of the multi-head shock wave electrode structure of the present application;

[0015] Fig. 7 is a top view structural schematic diagram of a fourth specific embodiment of the multi-head shock wave electrode structure of the present application;

[0016] Fig. 8 is a B-B sectional view schematic diagram of Fig. 7.

[0017] Reference numerals in the drawings: 1, first emitting electrode; 2, first intermediate electrode; 3, second emitting electrode; 4, second intermediate electrode; 5, first electrode body; 6, first insulating portion; 7, second insulating portion; 8, second electrode body; 9, first circular through cavity; 10, second circular through cavity; 11, fifth through cavity; 12, third emitting electrode; 13, third intermediate electrode; 14, fourth emitting electrode; 15, fourth intermediate electrode; 16, fifth emitting electrode; 17, fifth intermediate electrode; 18, third electrode body; 19, third insulating portion; 20, fourth insulating portion; 21, fifth insulating portion; 22, sixth through cavity. DETAILED DESCRIPTION

[0018] The embodiments of the present application will be described in detail below with reference to the drawings.

[0019] The above embodiments of the present application are described with reference to the specific examples, but the person skilled in the art can easily understand other advantages and effects of the present application from the disclosure of the present specification. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. The present application can also be implemented or applied by other different specific embodiments, and the details in the present specification can be modified or changed based on different views and applications without departing from the spirit of the present application. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict. Based on the embodiments in the present application, all other embodiments obtained by the person skilled in the art without creative labor are within the scope of protection of the present application.

[0020] Since the shock wave balloon catheter of the prior art is only used to form a crack on the tissue to be treated of the tubular (for example, coronary and peripheral vascular) structure, the shock wave generating device is arranged on the side wall of the shock wave balloon catheter and is in close contact with the tissue to be treated, the utilization rate of shock wave energy is high, and therefore, a single energy of shock wave can achieve the formation of a crack on the tissue to be treated of the blood vessel. However, for the hardened tissue (for example, calcified lesion tissue) of the site (for example, the mitral valve and aortic valve of the human body) that cannot or is inconvenient to be expanded, the shock wave energy provided by the existing shock wave balloon catheter is too small to achieve a therapeutic effect. When using the existing shock wave balloon catheter to attempt to achieve a larger shock wave energy, the heat energy generated with the larger shock wave energy causes the shock wave balloon catheter to be quickly disabled due to the melting ablation of the electrode and the melting and cracking of the insulating layer. The inventor of the present application found in the process of realizing a large energy shock wave that the mechanical impact force formed with the large energy shock wave has a great challenge to the mechanical reliability of the shock wave generating device, and even can displace the electrode and the insulating layer from each other, so that the shock wave balloon catheter is disabled and still cannot achieve the treatment of the site that cannot or is inconvenient to be expanded. Therefore, the multi-head shock wave electrode structure of the present application aims to release a shock wave through multiple discharge units at the same time, to realize a larger shock wave energy by using multiple shock wave energies to superimpose in space, to completely avoid the destruction of the electrode structure by the larger mechanical impact force generated with the larger shock wave energy, and to obtain a higher cumulative shock wave energy, so as to achieve the purpose of treating the hardened tissue of the site that cannot or is inconvenient to be expanded by using only the shock wave energy without the aid of expansion, to soften the hardened tissue and restore part of the tissue function, and to solve the problem that the hardened tissue of the lesion site cannot be treated by using the shock wave balloon catheter of the prior art or by using the shock wave balloon catheter of the prior art in cooperation with the expansion instrument.

[0021] In the description of the present application, "discharge unit" is used instead of shock wave electrode to more clearly illustrate the embodiments of the present application. "Distal end" refers to the end far from the operator, and "proximal end" refers to the end close to the operator. Single shock wave refers to the shock wave released by a single discharge breakdown of a discharge unit. Single energy refers to the single energy of the shock wave released by a single shock wave. Effective shock wave refers to a single shock wave having a therapeutic effect on the tissue to be treated. Effective discharge breakdown refers to a discharge breakdown between discharge units that can form an effective shock wave. Action distance refers to the distance between the position where the effective shock wave occurs and the tissue to be treated. Service life refers to the total number of effective shock waves that can be released by the shock wave electrode structure. Cumulative shock wave energy refers to the sum of the single energies of all effective shock waves that can be released by the shock wave electrode structure. Discharge distance refers to the electrical gap (when the launch electrode and the intermediate electrode are only insulated by air) or the creepage distance (when there is an insulator affecting the electrical gap between the launch electrode and the intermediate electrode) between the launch electrode and the intermediate electrode in the same discharge unit. When the shock wave energy released by a single discharge breakdown of a discharge unit is large enough and the action distance is close enough to have a therapeutic effect on the more serious tissue to be treated, the discharge breakdown is considered to be an effective discharge breakdown. The greater the shock wave energy released by a single effective discharge breakdown, the greater the heat and mechanical impact force generated by the shock wave.

[0022] When used in the human body, interventional medical devices are often limited by the physiological size of the treatment site. Therefore, the cross-sectional area of the over-head shock wave electrode structure of the present application cannot be too large, otherwise the shock wave balloon catheter of the present application will not be able to be smoothly delivered to the treatment site. At the same time, in order to achieve the purpose of treating hardened tissue at a site that cannot or is inconvenient to expand, the multi-head shock wave electrode structure of the present application needs to achieve a larger shock wave energy in the direction of the electrode axis forward.

[0023] The embodiment of the present application provides a multi-head shock wave electrode structure, at least two discharge units; each discharge unit comprises one launch electrode and one corresponding intermediate electrode which are spaced apart and have the same extension direction, the launch electrode is spaced apart and sleeved in the intermediate electrode one by one; all intermediate electrodes are electrically connected to each other; when the discharge end faces of all intermediate electrodes and the discharge end faces of all launch electrodes are located in the conductive fluid and a potential difference is formed between the launch electrodes of any two discharge units, the discharge end faces of the launch electrodes and the discharge end faces of the corresponding intermediate electrodes of the two discharge units simultaneously induce shock waves.

[0024] The "spaced and same direction of extension" of the transmitting electrode and the intermediate electrode means that both the transmitting electrode and the intermediate electrode extend between the proximal end and the distal end, and the extension direction of the intermediate electrode does not need to be parallel to the extension direction of the transmitting electrode. The side surfaces of the transmitting electrode and the corresponding intermediate electrode in the extension direction are insulated from each other, and the insulation strength value is greater than the applied voltage value; the discharge end surface of the transmitting electrode and the discharge end surface of the corresponding intermediate electrode are not insulated. Since the transmitting electrode is spaced and sleeved in the corresponding intermediate electrode one by one, the electrical distance between the discharge end surface of the transmitting electrode and the discharge end surface of the corresponding intermediate electrode is the shortest electrical distance between the transmitting electrode and the intermediate electrode. Therefore, when the discharge end surfaces of all the intermediate electrodes and the discharge end surfaces of all the transmitting electrodes are located in the conductive fluid and a potential difference is formed between the transmitting electrodes of any two discharge units, the transmitting electrode and the corresponding intermediate electrode belonging to the same discharge unit have the shortest electrical distance, and therefore, the discharge end surface of the transmitting electrode and the discharge end surface of the corresponding intermediate electrode of the two discharge units simultaneously induce shock waves, that is, two shock waves are simultaneously formed, the single energy of the two shock waves is superimposed in space, and constitutes the shock wave energy released in a single effective discharge breakdown, so that a larger shock wave energy can be released in a single effective discharge breakdown. Since the single energy of each shock wave is about half of the larger shock wave energy, the mechanical impact force brought by each shock wave is also weakened by half. At the same time, due to the spatial interval between one discharge unit and another discharge unit, the mechanical impact force brought by the shock wave released by the one discharge unit greatly weakens the influence on the other discharge unit. Thus, the multi-head shock wave electrode structure of the present application not only realizes a larger shock wave energy in a single effective discharge breakdown, but also solves the problem of the destruction of the electrode structure caused by the larger mechanical impact force accompanying the larger shock wave energy, thereby solving the problem that the existing technology cannot use shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand, achieving the purpose of treating hardened tissues in parts that cannot or are inconvenient to expand only by using shock wave energy without the aid of expansion, softening these hardened tissues and restoring part of the tissue function. In addition, since the transmitting electrode is spaced and sleeved in the corresponding intermediate electrode, the transmitting electrode can discharge and break down to release a shock wave between the entire inner circumference of the transmitting electrode and the corresponding intermediate electrode under the condition that the applied voltage and the ablation of the transmitting electrode are allowed, thereby effectively increasing the number of effective shock waves that can be induced by the multi-head shock wave electrode structure of the present application and prolonging the service life of the multi-head shock wave electrode structure of the present application.

[0025] In one embodiment, the multi-head shock wave electrode structure of the present application comprises a main body structure made of insulating material; all the intermediate electrodes are electrically connected to each other, which can be achieved by all the intermediate electrodes being in contact with each other, or all the intermediate electrodes being spaced apart from each other and electrically connected. When the intermediate electrodes are spaced apart from each other, if the distance between two adjacent intermediate electrodes is very small, the two intermediate electrodes are in a state of discharge breakdown under a small potential difference. After discharge breakdown, the two intermediate electrodes are equivalent to the state of wire connection. When the discharge end faces of all the intermediate electrodes and the discharge end faces of all the emission electrodes are located in the conductive fluid and a potential difference is formed between the emission electrodes of any two discharge units, the discharge end faces of the two emission electrodes and the discharge end faces of the corresponding intermediate electrodes simultaneously induce shock waves. The electrical distance of each discharge unit is the shortest distance between the discharge end face of each emission electrode and the discharge end face of the corresponding intermediate electrode.

[0026] In another embodiment, the multi-head shock wave electrode structure of the present application can comprise an electrode main body made of conductive material, at least two through cavities are formed in the electrode main body, the extension direction of the through cavities is the same as the extension direction of the emission electrodes, and the emission electrodes are correspondingly sleeved in the through cavities. Those skilled in the art should understand that the extension direction here only means that the through cavities and the emission electrodes both extend between the proximal end and the distal end, and the extension direction of the through cavities does not need to be parallel to the extension direction of the emission electrodes. That is, all the intermediate electrodes are an integral structure and constitute the electrode main body, the emission electrodes and the inner cavity side wall of the corresponding through cavity are insulated from each other, and the insulation strength value is greater than the applied voltage value; the discharge end face of the emission electrode and the discharge end face of the through cavity (i.e. the interface between the corresponding through cavity and the electrode main body) are not insulated. When the discharge end faces of all the through cavities and the discharge end faces of all the emission electrodes are located in the conductive fluid and a potential difference is formed between the emission electrodes of any two discharge units, the discharge end faces of the emission electrodes of the two discharge units and the discharge end faces of the corresponding through cavities simultaneously induce shock waves. The electrical distance of each discharge unit is the shortest distance between the discharge end face of each emission electrode and the discharge end face of the corresponding through cavity.

[0027] The shock wave is a spherical wave. In order to obtain a wider propagation range of the shock wave in space, the discharge end face of the emission electrode and the discharge end face of the corresponding intermediate electrode are located in the same plane or the same circular arc surface, so that the shock wave formed between the discharge end face of the emission electrode and the discharge end face of the corresponding intermediate electrode can propagate within a range of 180° based on the plane, and a larger shock wave energy coverage range is obtained.

[0028] Since the single energy of the shock wave has a positive growth relationship with the discharge distance between the transmitting electrode and the intermediate electrode, preferably, any transmitting electrode and its corresponding intermediate electrode are uniformly spaced to substantially uniformly release the single energy of the shock wave in the process of releasing the shock wave by the single discharge unit. Also preferably, the spacing distance between any transmitting electrode and its corresponding intermediate electrode is equal to substantially uniformly release the single energy of the shock wave in the process of releasing the shock wave by all the discharge units, so that the uniformity of the distribution of the shock wave energy in space is relatively high, and a relatively uniform treatment effect is obtained.

[0029] The inventors also propose in this application that an insulating part made of inorganic solid insulating material is filled between any transmitting electrode and its corresponding intermediate electrode, and the discharge end surface of the insulating part and the discharge end surface of the intermediate electrode are located in the same plane or the same circular arc surface. Since the thermal conductivity, melting point and impact strength of the inorganic solid insulating material are higher than those of the high polymer insulating material used in the prior art, the melting of the insulating part made of inorganic solid insulating material under the action of heat generated with the formation of the shock wave is extremely small, and a large amount of melting and molecular structure unknown cracking will not be generated, thus completely solving the problem that the use of high polymer insulating material in the existing shock wave electrode will cause a rapid and large change in the discharge condition of the shock wave electrode, thus leading to the failure of the shock wave electrode and the inability to continue discharging. In particular, when the discharge end surface of the transmitting electrode, the discharge end surface of the intermediate electrode corresponding to the transmitting electrode and the insulating part filled between the transmitting electrode and the intermediate electrode are located in the same plane or the same circular arc surface, the mechanical impact force generated with the formation of the shock wave, the melting of the transmitting electrode and the intermediate electrode in the process of discharge breakdown and the melting of the insulating part will be carried away by the conductive fluid under the action of the impact force reflected by the plane, thus making the multi-head shock wave electrode structure of this application have a self-cleaning function, so as to avoid the accumulation of the melting of the transmitting electrode and the intermediate electrode and the melting of the insulating part to have a large negative impact on the effective discharge breakdown, thus completely avoiding the failure of the embodiments of the application. The inorganic solid insulating material includes oxide ceramic, mineral, glass and quartz, and is preferably monoclinic zirconium oxide, tetragonal zirconium oxide with iridium oxide as the stabilizer or cubic zirconium oxide with iridium oxide as the stabilizer.

[0030] The multi-head shock wave electrode structure of this application can also include at least two first through cavities in the same extension direction as the transmitting electrode. For example, the through cavity is located in the main body structure made of insulating material or in the electrode main body made of conductive material; if the through cavity is located at the center position of the main body structure or the electrode main body, it can be used as a guide wire cavity; if the through cavity is arranged adjacent to the transmitting electrode and the intermediate electrode, it can be used as an inflow cavity of the conductive fluid and an outflow cavity of the conductive fluid.

[0031] The following will take the discharge unit arranged at the distal end surface of the multi-head shock wave electrode structure of the present application as an example to illustrate the structure of the multi-head shock wave electrode structure of the present application.

[0032] In a practical embodiment, the multi-head shock wave electrode structure of the present application comprises a first discharge unit and a second discharge unit; the first discharge unit comprises a first emitting electrode 1 in a cylindrical structure and a first intermediate electrode 2 uniformly and spacedly sleeved on the outer circumference of the first emitting electrode 1; the second discharge unit comprises a second emitting electrode 3 in a cylindrical structure and a second intermediate electrode 4 uniformly and spacedly sleeved on the outer circumference of the second emitting electrode 3, and the outer diameter of the second emitting electrode 3 is equal to that of the first emitting electrode 1.

[0033] In the first specific embodiment, the first intermediate electrode 2 and the second intermediate electrode 4 are externally provided with a first electrode body 5 made of insulating material, and the first intermediate electrode 2 and the second intermediate electrode 4 are in a cylindrical structure with equal inner diameter and equal outer diameter. Alternatively, as shown in FIG. 1, the first intermediate electrode 2 and the second intermediate electrode 4 are in contact with each other. Alternatively, as shown in FIG. 2, the first intermediate electrode 2 and the second intermediate electrode 4 are arranged with a spacing therebetween, and are electrically connected therebetween, for example, the first intermediate electrode 2 and the second intermediate electrode 4 are connected by a wire, or the spacing between the first intermediate electrode 2 and the second intermediate electrode 4 is very small, and a discharge breakdown is formed under a very small potential difference, which is equivalent to being connected by a wire. As known from the foregoing, when the first emitting electrode 1 and the second emitting electrode 3 are made of the same conductive material, the first discharge unit and the second discharge unit are the same discharge unit (the discharge distance, the exposed area of the electrode during discharge, and the electrode material are all the same). Since the electrical distance in the first discharge unit and the electrical distance in the second discharge unit are equal, the single energy of the shock wave formed by the first discharge unit and the single energy of the shock wave formed by the second discharge unit are equal in a single discharge breakdown. In a preferred embodiment of the present embodiment, the first emitting electrode 1 and the first intermediate electrode 2 can be further filled with a first insulating part 6 made of inorganic solid insulating material, and the second emitting electrode 3 and the second intermediate electrode 4 can be further filled with a second insulating part 7 made of inorganic solid insulating material. Further, the discharge end surface of the first emitting electrode 1, the discharge end surface of the first intermediate electrode 2, and the outer surface of the first insulating part 6 constitute the outer surface of the first discharge unit, the discharge end surface of the second emitting electrode 3, the discharge end surface of the second intermediate electrode 4, and the outer surface of the second insulating part 7 constitute the outer surface of the second discharge unit, and the outer surface of the first discharge unit and the outer surface of the second discharge unit are located in the same plane.

[0034] In the second embodiment, as shown in FIG. 3 and FIG. 4, the first intermediate electrode 2 and the second intermediate electrode 4 are integrated and constitute the second electrode body 8, the second electrode body 8 made of conductive material is provided with the first circular through cavity 9 and the second circular through cavity 10 with the same inner diameter, the first emitting electrode 1 is uniformly and spacedly sleeved in the first circular through cavity 9, and the second emitting electrode 3 is uniformly and spacedly sleeved in the second circular through cavity 10. At this time: the first intermediate electrode 2 is constituted by the first circular through cavity 9 and the joint position of the first circular through cavity 9 and the outer surface of the second electrode body 8, and the discharge end surface of the first intermediate electrode 2 is the joint position of the first circular through cavity 9 and the outer surface of the second electrode body 8; the second intermediate electrode 4 is constituted by the second circular through cavity 10 and the joint position of the second circular through cavity 10 and the outer surface of the second electrode body 8, and the discharge end surface of the second intermediate electrode 4 is the joint position of the second circular through cavity 10 and the outer surface of the second electrode body 8. Similarly, the first discharge unit and the second discharge unit are the same discharge unit, and the single energy of the shock wave formed by the first discharge unit is equal to the single energy of the shock wave formed by the second discharge unit. In a preferred embodiment of the present embodiment, the first insulating part and the second insulating part made of inorganic solid insulating material can be respectively filled in the first circular through cavity 9 and the second circular through cavity 10. Further, the discharge end surface of the first emitting electrode 1, the discharge end surface of the first intermediate electrode 2 and the outer surface of the first insulating part constitute the outer surface of the first discharge unit, the discharge end surface of the second emitting electrode 3, the discharge end surface of the second intermediate electrode 4 and the outer surface of the second insulating part constitute the outer surface of the second discharge unit, and the outer surface of the first discharge unit and the outer surface of the second discharge unit are located in the same plane. In the embodiment shown in FIG. 3 and FIG. 4, the multi-head shock wave electrode structure of the present application is provided with two fifth through cavities 11 as the inflow cavity of the conductive fluid and the outflow cavity of the conductive fluid.

[0035] The third embodiment is shown in FIG. 5, the discharge end surface of the first emitting electrode 1 and the discharge end surface of the first intermediate electrode 2 are located in the same plane, the discharge end surface of the second emitting electrode 3 and the discharge end surface of the second intermediate electrode 4 are located in the same plane, and the distal end surface of the multi-head shock wave electrode structure is not a plane, which can effectively reduce the passing size of the multi-head shock wave electrode structure, and the distribution range of the shock waves released by the first discharge unit and the second discharge unit in space is larger, which is suitable for the situation that the passing space to the treated tissue is narrow and the distribution range of the treated tissue is larger.

[0036] In the first embodiment, the second embodiment and the third embodiment, one of the first emitting electrode 1 and the second emitting electrode 3 is positive, and the other is negative. Since the ablation speed of the positive electrode is faster during the discharge breakdown, the emitting electrode as the positive electrode can use the electrode material with higher melting point, or the positive and negative electrodes can be exchanged during the discharge process to prolong the service life of the multi-head shock wave electrode structure of the present application. For example, 100 times of shock waves, the positive and negative electrodes are exchanged once. That is, the first 100 times of shock waves, the first emitting electrode 1 is positive, and the second emitting electrode 3 is negative; the last 100 times of shock waves, the first emitting electrode 1 is negative, and the second emitting electrode 3 is positive. The implementation of the positive and negative electrode exchange strategy, that is, the polarity of the electrodes is alternated after each group of fixed number of shock waves, can balance the ablation rate, prolong the service life, improve the discharge efficiency and the reliability of the equipment.

[0037] In another practical embodiment, the multi-head shock wave electrode structure of the present application includes a third discharge unit, a fourth discharge unit and a fifth discharge unit; the third discharge unit includes a third emitting electrode 12 in a cylindrical structure and a third intermediate electrode 13 uniformly and spacedly sleeved on the outer circumference of the third emitting electrode 12; the fourth discharge unit includes a fourth emitting electrode 14 in a cylindrical structure and a fourth intermediate electrode 15 uniformly and spacedly sleeved on the outer circumference of the fourth emitting electrode 14; the fifth discharge unit includes a fifth emitting electrode 16 in a cylindrical structure and a fifth intermediate electrode 17 uniformly and spacedly sleeved on the outer circumference of the fifth emitting electrode 16; the outer diameters of the third emitting electrode 12, the fourth emitting electrode 14 and the fifth emitting electrode 16 are equal.

[0038] In the fourth embodiment, the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are provided with a third electrode body 18 made of an insulating material outside, and the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are in a cylindrical structure with the same inner diameter and the same outer diameter. It can be that the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are in contact with each other. It can also be that, as shown in FIGS. 6 to 8, any two of the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are provided with a spacing therebetween and are electrically connected, which can be through a wire or with a very small spacing. Similarly, the third discharge unit, the fourth discharge unit and the fifth discharge unit are the same discharge unit, and the single-time energy of the shock wave formed by the third discharge unit, the single-time energy of the shock wave formed by the fourth discharge unit and the single-time energy of the shock wave formed by the fifth discharge unit are equal. In a preferred embodiment of the present embodiment, the third intermediate electrode 13 and the third emission electrode 12 can be further filled with a third insulating part 19 made of inorganic solid insulating material, the fourth intermediate electrode 15 and the fourth emission electrode 14 can be further filled with a fourth insulating part 20 made of inorganic solid insulating material, and the fifth intermediate electrode 17 and the fifth emission electrode 16 can be further filled with a fifth insulating part 21 made of inorganic solid insulating material. Further, the discharge end surface of the third emission electrode 12, the discharge end surface of the third intermediate electrode 13 and the outer surface of the third insulating part 19 constitute the outer surface of the third discharge unit, the discharge end surface of the fourth emission electrode 14, the discharge end surface of the fourth intermediate electrode 15 and the outer surface of the fourth insulating part 20 constitute the outer surface of the fourth discharge unit, the discharge end surface of the fifth emission electrode 16, the discharge end surface of the fifth intermediate electrode 17 and the outer surface of the fifth insulating part 21 constitute the outer surface of the fifth discharge unit, and the outer surface of the third discharge unit, the outer surface of the fourth discharge unit and the outer surface of the fifth discharge unit are located in the same plane. A third sixth through cavity 22 can be further provided.

[0039] In the fifth specific embodiment, the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are integrated and constitute a fourth electrode body, the fourth electrode body is provided with third, fourth and fifth circular through cavities with equal radius, the third, fourth and fifth transmitting electrodes 12, 14 and 16 are uniformly and separately sleeved in the third, fourth and fifth circular through cavities respectively. At this time, the third intermediate electrode 13 is composed of the third circular through cavity and the joint position of the third circular through cavity and the outer surface of the fourth electrode body, and the discharge end surface of the third intermediate electrode 13 is the joint position of the third circular through cavity and the outer surface of the fourth electrode body; the fourth intermediate electrode 15 is composed of the fourth circular through cavity and the joint position of the fourth circular through cavity and the outer surface of the fourth electrode body, and the discharge end surface of the fourth intermediate electrode 15 is the joint position of the fourth circular through cavity and the outer surface of the fourth electrode body; the fifth intermediate electrode 17 is composed of the fifth circular through cavity and the joint position of the fifth circular through cavity and the outer surface of the fourth electrode body, and the discharge end surface of the fifth intermediate electrode 17 is the joint position of the fifth circular through cavity and the outer surface of the fourth electrode body. Similarly, the third, fourth and fifth discharge units are the same discharge unit, and the single energy of the shock wave formed by the third, fourth and fifth discharge units is equal. In a preferred embodiment of the present embodiment, the third, fourth and fifth circular through cavities can be filled with an insulation part made of inorganic solid insulation material. Those skilled in the art should understand the composition of the outer surface of the third discharge unit, the outer surface of the fourth discharge unit and the outer surface of the fifth discharge unit. Further, the outer surface of the third discharge unit, the outer surface of the fourth discharge unit and the outer surface of the fifth discharge unit are located in the same plane.

[0040] In the fourth and fifth specific embodiments, the third, fourth and fifth transmitting electrodes 13, 15 and 17 are provided, two of which are selected as the positive and negative electrodes of the discharge breakdown each time, and the polarity of the electrodes is alternated after each group of fixed number of shock wave releases, which can effectively balance the ablation rate, greatly prolong the service life, effectively improve the discharge efficiency and the reliability of the equipment.

[0041] In the above-mentioned five specific embodiments, the transmitting electrodes are uniformly and separately sleeved in the corresponding intermediate electrodes, so that the transmitting electrodes can discharge and break down between the entire inner circumference of the corresponding intermediate electrodes to release the shock wave under the implementation of the voltage and the ablation permission of the transmitting electrodes, which effectively increases the number of effective shock waves that can be triggered by the multi-head shock wave electrode structure of the present application, and prolongs the service life of the multi-head shock wave electrode structure of the present application.

[0042] From the above, the multi-head shock wave electrode structure of the present application is also applicable to be arranged on the side circumferential surface thereof, at this time, the outer surfaces of the discharge units (including the discharge end surfaces of the emission electrodes and the discharge end surfaces of the intermediate electrodes, and can also include the outer surfaces of the insulating portions) are located on the same circular arc surface.

[0043] The present application also provides a shock wave balloon catheter, which comprises the multi-head shock wave electrode structure, a tube body and an inflation element capable of being filled with conductive fluid as described above; the inflation element is sealingly connected to the distal end of the tube body, and the discharge end surfaces of all the emission electrodes and the discharge end surfaces of all the intermediate electrodes of the multi-head shock wave electrode structure are located in the inflation element; when the inflation element is filled with conductive fluid and a potential difference is formed between any two emission electrodes of the multi-head shock wave electrode structure, the discharge end surfaces of the two emission electrodes forming the potential difference simultaneously induce shock waves with the discharge end surfaces of the corresponding intermediate electrodes. The tube body comprises a catheter body for entering the human body and other extracorporeal parts, such as a handle, side branches and other circuit interfaces and liquid path interfaces.

[0044] In the process of forming shock waves by using liquid electricity, small bubbles are formed on the discharge end surfaces of the emission electrodes and the discharge end surfaces of the intermediate electrodes, and small bubbles that are not processed in time also form large bubbles in the conductive fluid. If the large bubbles are not processed in time, they will slowly move to the inner wall of the inflation element. The small bubbles accumulated on the discharge surfaces will affect the conductivity of the conductive fluid, and further affect the discharge breakdown between the discharge end surfaces of the emission electrodes and the discharge end surfaces of the intermediate electrodes. The large bubbles in the conductive fluid will affect the intensity (size of shock wave energy) of the shock wave in the process of shock wave transmission. At the same time, both the large bubbles and the small bubbles will scatter the shock wave energy and weaken the shock wave energy. Therefore, the shock wave balloon catheter of the present application further provides a circulation system for the conductive fluid, so that the conductive fluid flows in the process of discharge breakdown, so as to take away the large bubbles and the small bubbles through the flowing conductive fluid.

[0045] In the first embodiment, the multi-head shock wave electrode structure comprises at least two first through cavities, and the distal end openings of all the first through cavities are located in the inflation element. The first through cavity located at the center of the multi-head shock wave electrode structure of the present application can be used as a guide wire cavity. The first through cavities (such as the fifth through cavity 11 and the sixth through cavity 22 in the foregoing) arranged adjacent to the emission electrodes and the intermediate electrodes can be used as an inflow cavity for the conductive fluid and an outflow cavity for the conductive fluid. The conductive fluid enters from the inflow cavity and is discharged through the outflow cavity, and with the flow of the conductive fluid, the large bubbles can be taken away. Since the inflow cavity and the outflow cavity are adjacent to the emission electrodes and the intermediate electrodes, the conductive fluid can flush the discharge end surfaces of the emission electrodes and the discharge end surfaces of the intermediate electrodes, and can effectively take away the small bubbles.

[0046] In the second embodiment, the tube body of the shock wave balloon catheter of the present application is provided with at least two second through cavities, and the distal openings of all the second through cavities are located in the inflation element. With the flow of the conductive fluid, the large bubbles and small bubbles can be taken away.

[0047] In the third embodiment, the multi-head shock wave electrode structure comprises at least one third through cavity, and the tube body is provided with at least one fourth through cavity, and the distal openings of all the third through cavities and the distal openings of all the fourth through cavities are located in the inflation element. The third through cavity located at the center of the multi-head shock wave electrode structure can be used as a guide wire cavity. The third through cavities arranged near the transmitting electrode and the intermediate electrode can be used as the inflow cavity of the conductive fluid and the outflow cavity of the conductive fluid, and are preferably used as the inflow cavity of the conductive fluid. The fourth through cavity can be used as the inflow cavity of the conductive fluid and the outflow cavity of the conductive fluid, and is preferably used as the outflow cavity of the conductive fluid. When the third through cavity arranged near the transmitting electrode and the intermediate electrode is used as the inflow cavity of the conductive fluid, and the fourth through cavity is used as the outflow cavity of the conductive fluid, the conductive fluid enters from the inflow cavity and is discharged through the outflow cavity, and the conductive fluid flows from the inflow cavity near the transmitting electrode and the intermediate electrode to the outflow cavity of the tube body, and has a longer flow distance, so that the conductive fluid can effectively take away the large bubbles and small bubbles.

[0048] As described above, the multi-head shock wave electrode structure of the present application can realize single effective discharge breakdown to form a larger shock wave energy, and solve the problem of damage to the electrode structure caused by the larger mechanical impact force accompanying the larger shock wave energy, thereby solving the problem that the existing technology cannot use shock wave energy to treat the hardened tissues at sites that cannot or are inconvenient to expand, achieving the purpose of treating the hardened tissues at sites that cannot or are inconvenient to expand only by using shock wave energy without the aid of expansion, softening these hardened tissues and restoring part of the tissue function. At the same time, the multi-head shock wave electrode structure of the present application also has more effective shock wave initiation times and a longer service life.

[0049] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto, and any changes or replacements easily thought of by those skilled in the art within the technical scope disclosed in the present application should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A multi-head shock wave electrode structure, characterized in that, include: At least two discharge units; each discharge unit includes a emitting electrode and a corresponding intermediate electrode spaced apart and extending in the same direction, the emitting electrodes being spaced apart and nested within the intermediate electrode; all intermediate electrodes are electrically connected to each other; when the discharge end faces of all intermediate electrodes and all emitting electrodes are located in a conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, a shock wave is simultaneously generated between the discharge end faces of the emitting electrodes of these two discharge units and the discharge end faces of the corresponding intermediate electrodes.

2. The multi-head shock wave electrode structure according to claim 1, characterized in that, It includes a main structure made of insulating material; all intermediate electrodes are in contact with each other, or all intermediate electrodes are spaced apart and electrically connected.

3. The multi-head shock wave electrode structure according to claim 1, characterized in that, All intermediate electrodes are integral structures forming the electrode body. At least two through cavities are opened on the electrode body. The extension direction of the through cavities is the same as the extension direction of the transmitting electrodes. The transmitting electrodes are fitted into the through cavities one by one.

4. The multi-head shock wave electrode structure according to claim 1, characterized in that, The discharge end face of the emitting electrode and the discharge end face of the corresponding intermediate electrode are located on the same plane or the same arc surface; or, Each emitting electrode and its corresponding intermediate electrode are evenly spaced; or... The distance between each emitting electrode and its corresponding intermediate electrode is equal; or, An insulating portion made of inorganic solid insulating material is filled between each emitting electrode and its corresponding intermediate electrode, and the discharge end face of the insulating portion and the discharge end face of the intermediate electrode are located on the same plane or the same arc surface; or, It also includes at least one through cavity that extends in the same direction as the transmitting electrode.

5. The multi-head shock wave electrode structure according to any one of claims 1-4, characterized in that, It includes a first discharge unit and a second discharge unit; the first discharge unit includes a first emitting electrode with a cylindrical structure and a first intermediate electrode uniformly spaced and sleeved on the outer circumference of the first emitting electrode; the second discharge unit includes a second emitting electrode with a cylindrical structure and a second intermediate electrode uniformly spaced and sleeved on the outer circumference of the second emitting electrode, the outer diameter of the second emitting electrode being the same as that of the first emitting electrode.

6. The multi-head shock wave electrode structure according to claim 5, characterized in that, A first electrode body made of insulating material is disposed outside the first and second intermediate electrodes. The first and second intermediate electrodes are cylindrical structures with equal inner and outer diameters. The first and second intermediate electrodes are in contact with each other, or the first and second intermediate electrodes are spaced apart and electrically connected to each other; or the first and second intermediate electrodes are an integral structure and constitute the second electrode body. The second electrode body has a first circular through cavity and a second circular through cavity with equal inner diameter. The first emitting electrodes are uniformly spaced and sleeved in the first circular through cavity, and the second emitting electrodes are uniformly spaced and sleeved in the second circular through cavity.

7. The multi-head shock wave electrode structure according to any one of claims 1-4, characterized in that, It includes a third discharge unit, a fourth discharge unit, and a fifth discharge unit; the third discharge unit includes a cylindrical third emitting electrode and a third intermediate electrode uniformly spaced around the outer circumference of the third emitting electrode; the fourth discharge unit includes a cylindrical fourth emitting electrode and a fourth intermediate electrode uniformly spaced around the outer circumference of the fourth emitting electrode; the fifth discharge unit includes a cylindrical fifth emitting electrode and a fifth intermediate electrode uniformly spaced around the outer circumference of the fifth emitting electrode; the outer diameters of the third, fourth, and fifth emitting electrodes are equal.

8. The multi-head shock wave electrode structure according to claim 7, characterized in that, The third, fourth, and fifth intermediate electrodes are surrounded by a third electrode body made of insulating material. The third, fourth, and fifth intermediate electrodes are cylindrical structures with equal inner and outer diameters. The third, fourth, and fifth intermediate electrodes are in contact with each other, or they are spaced apart and electrically connected; or... The third, fourth, and fifth intermediate electrodes are integrated into a single structure and constitute the main body of the fourth electrode. The main body of the fourth electrode has a third, fourth, and fifth circular through-cavities of equal radius. The third transmitting electrode is uniformly spaced within the third circular through-cavity, the fourth transmitting electrode is uniformly spaced within the fourth circular through-cavity, and the fifth transmitting electrode is uniformly spaced within the fifth circular through-cavity.

9. A shockwave balloon catheter, characterized in that, include: The multi-head shock wave electrode structure, tube body, and expansion element capable of being filled with conductive fluid are as described in any one of claims 1-8. The expansion element is sealed and connected to the distal end of the tube body, and the discharge end faces of all emitting electrodes and all intermediate electrodes of the multi-head shock wave electrode structure are located within the expansion element. When the expansion element is filled with conductive fluid and a potential difference is formed between any two emitting electrodes of the multi-head shock wave electrode structure, shock waves are simultaneously generated between the discharge end faces of the two emitting electrodes forming the potential difference and the discharge end faces of their respective intermediate electrodes.

10. The shockwave balloon catheter according to claim 9, characterized in that, The multi-head shock wave electrode structure includes at least two first through-cavities, and the distal openings of all the first through-cavities are located within the expansion element; or, The tube body has at least two second through cavities, and the distal openings of all the second through cavities are located within the expansion element; or, The multi-head shock wave electrode structure includes at least one third through cavity, and the tube body has at least one fourth through cavity, and the distal openings of all the third through cavities and all the distal openings of the fourth through cavities are located inside the expansion element.

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