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

Abstract

The present invention provides a multi-head shock wave electrode structure and a shock wave balloon catheter. The multi-head shock wave electrode structure includes at least two discharge units; each discharge unit includes an emitter electrode and a corresponding intermediate electrode which are arranged at intervals and have the same extension direction, and the emitter electrodes are arranged in the intermediate electrode at intervals one by one; all the intermediate electrodes are electrically connected to each other; when the discharge end faces of all the intermediate electrodes and the discharge end faces of all the emitter electrodes are located in a conductive fluid and a potential difference is formed between the emitter electrodes of any two discharge units, shock waves are simultaneously triggered between the discharge end faces of the emitter electrodes of the two discharge units and the discharge end faces of the corresponding intermediate electrodes. The shock wave balloon catheter includes the multi-head shock wave electrode structure. The present invention solves the problem of damage caused by mechanical impact force while realizing a single effective discharge breakdown to form a large shock wave energy, and has a long service life.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a multi-head shock wave electrode structure and a shock wave balloon catheter. Background Art

[0002] The electrohydraulic shock wave is generated by electrodes in a conductive fluid. When a high-voltage pulse current is passed through two electrodes with a potential difference in a conductive fluid, a high-temperature arc will be generated between the two closest points on the two electrodes with a potential difference. While forming a shock wave, the high-temperature arc will generate a large amount of heat and form a strong mechanical impact force. The heat of the high-temperature arc can cause the two locations on the electrode where the shock wave is generated to melt and form ablation.

[0003] Current shock wave catheters are used to loosen or crack calcified diseased tissue in coronary or peripheral blood vessels, and then expand them by inflating the balloon, thereby alleviating the stenosis of the blood vessels or facilitating subsequent treatment. Shock wave catheters have been marketed and their safety and effectiveness have been fully verified. However, existing shock wave balloon catheters cannot achieve treatment for hardened tissue (such as calcified diseased tissue) in areas that cannot or are inconvenient to expand (such as the mitral valve and aortic valve of the human body). Summary of the invention

[0004] In view of this, the present invention provides a multi-head shock wave electrode structure and a shock wave balloon catheter, which are intended to release shock waves simultaneously through multiple discharge units, utilize the superposition of shock wave energy to achieve greater shock wave energy, and solve the problem of damage to the electrode structure caused by the greater mechanical impact force formed with the greater shock wave energy, thereby solving the problem that the prior art cannot use shock wave energy to treat hardened tissue in a part that cannot or is inconvenient to expand, and achieve the purpose of using only shock wave energy to treat hardened tissue in a part that cannot or is inconvenient to expand without the help of expansion, so as to soften these hardened tissues and restore some tissue functions.

[0005] An embodiment of the present invention provides a multi-head shock wave electrode structure, comprising at least two discharge units; each discharge unit comprises an emitting electrode and a corresponding intermediate electrode which are arranged at intervals and have the same extension direction, and the emitting electrodes are arranged in the intermediate electrode at intervals corresponding to each other; all the intermediate electrodes are electrically connected to each other; when the discharge end surfaces of all the intermediate electrodes and the discharge end surfaces of all the emitting electrodes are located in a conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, shock waves are simultaneously generated between the discharge end surfaces of the emitting electrodes of the two discharge units and the discharge end surfaces of the corresponding intermediate electrodes.

[0006] The present invention also provides a shock wave balloon catheter, comprising the multi-head shock wave electrode structure as described above, a tube body and an expansion element capable of being filled with a conductive fluid; the expansion element is sealed and connected to the distal end of the tube body, and the discharge end faces of all the emitting electrodes and the discharge end faces of all the intermediate electrodes of the multi-head shock wave electrode structure are located in the expansion element; when the expansion element is filled with a 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 triggered between the discharge end faces of the two emitting electrodes forming the potential difference and the discharge end faces of the corresponding intermediate electrodes.

[0007] Compared with the prior art, the beneficial effects that can be achieved by at least one of the above technical solutions adopted in the embodiments of this specification include at least: while achieving a single effective discharge breakdown to form a large shock wave energy, the problem of damage to the electrode structure caused by the large mechanical impact force formed by the large shock wave energy is solved, thereby solving the problem that the prior art cannot use shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand, and achieving the purpose of using only shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand without the help of expansion, so that these hardened tissues are softened and some tissue functions are restored. At the same time, the multi-head shock wave electrode structure of the present application also has a large number of effective shock wave initiation times and a long service life. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

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

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

[0011] Figure 3 It 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] Figure 4 is a schematic diagram of a top view of a second specific embodiment of the multi-head shock wave electrode structure of the present application;

[0013] Figure 5 It 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] Figure 6 It 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] Figure 7 is a schematic diagram of a top view of a fourth specific embodiment of a multi-head shock wave electrode structure of the present application;

[0016] Figure 8 yes Figure 7 BB cross-sectional view.

[0017] Reference numerals in the figures:

[0018] 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

[0019] The embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0020] The following describes the implementation methods of the present application through specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The present application can also be implemented or applied through other different specific implementation methods, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that, in the absence of conflict, the following embodiments and the features in the embodiments can be combined with each other. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without making creative work belong to the scope of protection of the present application.

[0021] Since the shock wave balloon catheter of the prior art is only used to form cracks on the tissue to be treated of a tubular structure (such as coronary arteries and peripheral blood vessels), the shock wave generating device is arranged on the side wall of the shock wave balloon catheter and is very easy to be close to the tissue to be treated, and the utilization rate of the shock wave energy is high. Therefore, a single shock wave with low energy can form cracks on the tissue to be treated of the blood vessel. However, for hardened tissue (such as calcified lesion tissue) in a part that cannot or is inconvenient to expand (such as the mitral valve and aortic valve of the human body), 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 try to achieve a larger shock wave energy, the heat energy generated by the larger shock wave energy causes the shock wave balloon catheter to quickly fail due to the melting ablation of the electrode and the melting and cracking of the insulation layer. The inventors of the present application found in the process of realizing high-energy shock waves that the mechanical impact force generated by the high-energy shock waves poses a great challenge to the mechanical reliability of the shock wave generating device, and can even cause the electrode and the insulating layer to shift relative to each other, causing the shock wave balloon catheter to fail, and still cannot achieve the treatment of the parts that cannot or are inconvenient to expand. To this end, the multi-head shock wave electrode structure of the present application is intended to release shock waves through multiple discharge units at the same time, and use multiple shock wave energies to superimpose each other in space to achieve a larger shock wave energy, completely avoiding the damage to the electrode structure caused by the larger mechanical impact force generated by the larger shock wave energy, thereby obtaining a higher cumulative shock wave energy, achieving the purpose of using only shock wave energy to treat the hardened tissue of the parts that cannot or are inconvenient to expand without the help of expansion, so that these hardened tissues are softened and some tissue functions are restored, solving the problem that the hardened tissue of the lesion part cannot be treated by the shock wave balloon catheter of the prior art, nor can it be treated by the shock wave balloon catheter of the prior art in combination with the expansion device.

[0022] In the description of the present application, "discharge unit" is used to replace the shock wave electrode to more clearly illustrate the embodiments of the present application. "Distal end" refers to the end away from the operator, and "proximal end" refers to the end close to the operator. A single shock wave refers to a shock wave released by a single discharge breakdown of a discharge unit. Single energy refers to the shock wave energy released by a single shock wave. An effective shock wave refers to a single shock wave that has a therapeutic effect on the treated tissue. An effective discharge breakdown refers to a discharge breakdown between discharge units that can form an effective shock wave. The effective distance refers to the distance between the location where the effective shock wave occurs and the tissue to be treated. The service life refers to the total number of effective shock waves that can be released by the shock wave electrode structure. The 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. The discharge distance refers to the electrical gap between the emitting electrode and the intermediate electrode in the same discharge unit (when the emitting electrode and the intermediate electrode are only insulated by air) or the creepage distance (when there is an insulator between the emitting electrode and the intermediate electrode that affects the electrical gap). When the shock wave energy released by the discharge unit during a single discharge breakdown is large enough and the action distance is close enough, it can have a therapeutic effect on the more seriously diseased tissue to be treated, and the discharge breakdown will be considered an effective discharge breakdown. The greater the shock wave energy released by an effective discharge breakdown, the more heat and mechanical impact force generated by the shock wave.

[0023] When interventional medical devices are applied to the human body, they are often limited by the physiological size of the treatment site. Therefore, the cross-sectional area of ​​the over-the-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 in 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 axial forward direction of the electrode.

[0024] The embodiment of the present invention provides a multi-head shock wave electrode structure, at least two discharge units; each discharge unit includes an emitting electrode and a corresponding intermediate electrode which are arranged at intervals and have the same extension direction, and the emitting electrodes are arranged in the intermediate electrode at intervals corresponding to each other; all the intermediate electrodes are electrically connected to each other; when the discharge end surfaces of all the intermediate electrodes and the discharge end surfaces of all the emitting electrodes are located in a conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, shock waves are simultaneously generated between the discharge end surfaces of the emitting electrodes of the two discharge units and the discharge end surfaces of the corresponding intermediate electrodes.

[0025] Among them, the emitting electrode and the intermediate electrode "arranged at intervals and extending in the same direction" only refer to that both the emitting electrode and the intermediate electrode extend between the proximal end and the distal end, and it is not necessary for the extension direction of the intermediate electrode to be parallel to the extension direction of the emitting electrode. The lateral sides of the emitting 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 face of the emitting electrode and the discharge end face of the corresponding intermediate electrode are non-insulated. Since the emitting electrodes are spaced and sleeved in the corresponding intermediate electrodes one by one, the electrical distance between the discharge end face of the emitting electrode and the discharge end face of the corresponding intermediate electrode is the shortest electrical distance between the emitting electrode and the intermediate electrode. Therefore, when the discharge end faces of all the intermediate electrodes and the discharge end faces of all the emitting electrodes are located in the conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, the electrical distance between the emitting electrode and the corresponding intermediate electrode belonging to the same discharge unit is the shortest. Therefore, shock waves are simultaneously induced between the discharge end faces of the emitting electrodes of the two discharge units and the discharge end faces of the corresponding intermediate electrodes, that is, two shock waves are simultaneously formed. The single energies of the two shock waves are superimposed on each other in space, constituting the shock wave energy released during a single effective discharge breakdown, thereby achieving a single effective discharge breakdown that can release a larger shock wave energy. Since the single energy of each shock wave is approximately half of the energy of the larger shock wave, the mechanical impact force brought by each shock wave is also weakened by half accordingly. At the same time, due to the spatial interval between one discharge unit and another discharge unit, the influence of the mechanical impact force brought by the shock wave released by this discharge unit on the other discharge unit is greatly weakened. Therefore, the multi-head shock wave electrode structure of the present application solves the problem of damage to the electrode structure caused by the large mechanical impact force formed by the large shock wave energy while realizing a single effective discharge breakdown to form a large shock wave energy, thereby solving the problem that the prior art cannot use shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand, and achieves the purpose of using only shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand without the help of expansion, so as to soften these hardened tissues and restore some tissue functions. In addition, since the emitting electrodes are arranged in intervals in the corresponding intermediate electrodes, when the implementation voltage and the ablation of the emitting electrodes allow, the emitting electrodes can discharge and break down between the entire inner circumference of the corresponding intermediate electrodes to release shock waves, which effectively increases the number of effective shock waves that can be generated by the multi-head shock wave electrode structure of the present application and increases the service life of the multi-head shock wave electrode structure of the present application.

[0026] In one embodiment, the multi-head shock wave electrode structure of the present application includes a main structure made of insulating material; "all the intermediate electrodes are electrically connected to each other" can be achieved by all the intermediate electrodes being in contact with each other, or all the intermediate electrodes are arranged in pairs and electrically connected. When the intermediate electrodes are arranged in pairs, if the spacing between two adjacent intermediate electrodes is very small, then the two intermediate electrodes are discharged and broken down when the potential difference is very small, and the two intermediate electrodes after the discharge breakdown are equivalent to the state of being connected by wires. When the discharge end faces of all the intermediate electrodes and the discharge end faces of all the emitting electrodes are located in the conductive fluid and a 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 two emitting electrodes and the discharge end faces of the corresponding intermediate electrodes. The electrical distance of each discharge unit is the shortest distance between the discharge end faces of each emitting electrode and the discharge end faces of the corresponding intermediate electrodes.

[0027] In another embodiment, the multi-head shock wave electrode structure of the present application may include an electrode body made of a conductive material, at least two through cavities are provided on the electrode body, the extension direction of the through cavity is the same as the extension direction of the emitting electrode, and the emitting electrode is sleeved in the through cavity one by one. Those skilled in the art should understand that the same extension direction here only refers to that the through cavity and the emitting electrode both extend between the proximal end and the distal end, and it is not necessary for the extension direction of the through cavity to be parallel to the extension direction of the emitting electrode. That is, all the intermediate electrodes are an integrated structure and constitute this electrode body, the emitting electrode 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 emitting electrode and the discharge end face of the through cavity (that is, the interface between the corresponding through cavity and the electrode body) are non-insulated. When the discharge end faces of all through cavities 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, shock waves are simultaneously triggered between the discharge end faces of the emitting electrodes of the two discharge units and the discharge end faces of the corresponding through cavities. The electrical distance of each discharge unit is the shortest distance between the discharge end surface of each emitter electrode and the discharge end surface of the corresponding through cavity.

[0028] The shock wave is a spherical wave. In order to obtain a wider propagation range of the shock wave in space, it is preferred that the discharge end face of the emitting electrode and the discharge end face of the intermediate electrode corresponding to the emitting electrode are located in the same plane or the same arc surface. Thus, the shock wave formed between the discharge end face of the emitting electrode and the discharge end face of the intermediate electrode corresponding to the emitting electrode can propagate within a range of 180° based on the plane, thereby obtaining a larger shock wave energy coverage range.

[0029] Since the single energy of the shock wave is in a positive growth relationship with the discharge distance between the emitting electrode and the middle electrode, preferably, any emitting electrode and its corresponding middle electrode are evenly spaced, so that in the process of releasing the shock wave in a single discharge unit, the single energy is basically uniform. Also preferably, the spacing distance between any emitting electrode and its corresponding middle electrode is equal, so that in the process of releasing the shock wave in all discharge units, the single energy of the two shock waves obtained is basically uniform, 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.

[0030] The inventors of the present invention also propose in the present application that an insulating part made of an inorganic solid insulating material is filled between any emitting electrode and its corresponding intermediate electrode, and the discharge end face of the insulating part and the discharge end face of the intermediate electrode are located in the same plane or the same arc surface. Since the thermal conductivity, melting point and impact strength of the inorganic solid insulating material are higher than those of the polymer insulating material used in the prior art, the insulating part made of the inorganic solid insulating material produces very little melt under the action of the heat generated by the shock wave, and will not produce a large amount of melt and cracked products with unknown molecular structure, which completely solves the problem that the use of polymer insulating materials in the existing shock wave electrode will cause the discharge conditions of the shock wave electrode to change rapidly and significantly, thereby causing the shock wave electrode to fail and be unable to continue to discharge. In particular, when the discharge end face of the emitter electrode, the discharge end face of the intermediate electrode corresponding to the emitter electrode, and the insulating part filled between the emitter electrode and the intermediate electrode are located in the same plane or the same arc surface, the mechanical impact force generated by the formation of the shock wave, the melt produced by the ablation of the emitter electrode and the intermediate electrode during the discharge breakdown process and the melt of the insulating part will be carried away by the conductive fluid under the action of the impact force reflected by the plane, so that the multi-head shock wave electrode structure of the present application has a self-cleaning function, so as to avoid the accumulation of the melt of the emitter electrode and the intermediate electrode and the melt of the insulating part from having a greater negative impact on the effective discharge breakdown, and completely avoid the failure of the embodiment of the present invention. Among them, the inorganic solid insulating material includes oxide ceramics, minerals, glass and quartz, preferably monoclinic zirconium oxide, tetragonal zirconium oxide with iridium oxide as the stabilizer, or cubic zirconium oxide with iridium oxide as the stabilizer.

[0031] The multi-head shock wave electrode structure of the present application may also include at least two first through cavities extending in the same direction as the transmitting electrode. For example, the through cavity is located in the main structure made of insulating material or in the electrode body made of conductive material; if the through cavity is located in the center of the main structure or the electrode body, it can be used as a guide wire cavity; if the through cavity is arranged near the transmitting electrode and the intermediate electrode, it can be used as an inflow cavity for conductive fluid and an outflow cavity for conductive fluid.

[0032] The structure of the multi-head shock wave electrode structure of the present application is described below by taking the example that the discharge unit is arranged on the distal end surface of the multi-head shock wave electrode structure of the present application.

[0033] In an embodiment suitable for practical use, the multi-head shock wave electrode structure of the present application includes a first discharge unit and a second discharge unit; the first discharge unit includes a first emitting electrode 1 with a cylindrical structure and a first intermediate electrode 2 evenly spaced and sleeved on the outer circumference of the first emitting electrode 1; the second discharge unit includes a second emitting electrode 3 with a cylindrical structure and a second intermediate electrode 4 evenly spaced and sleeved on the outer circumference of the second emitting electrode 3, and the outer diameter of the second emitting electrode 3 is the same as that of the first emitting electrode 1.

[0034] In the first specific embodiment, a first electrode body 5 made of insulating material is disposed outside the first intermediate electrode 2 and the second intermediate electrode 4, and the first intermediate electrode 2 and the second intermediate electrode 4 are cylindrical structures with equal inner diameters and outer diameters. Figure 1 As shown, the first intermediate electrode 2 and the second intermediate electrode 4 are in contact with each other. Figure 2 As shown, the first intermediate electrode 2 and the second intermediate electrode 4 are arranged at intervals, and the first intermediate electrode 2 and the second intermediate electrode 4 are electrically connected, 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 can be seen from the above, 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 units (the discharge distance, the exposed area of ​​the electrode during discharge, and the electrode material are the same). Since the electrical distance in the first discharge unit is equal to the electrical distance in the second discharge unit, 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 during a single discharge breakdown. In a preferred implementation of this embodiment, a first insulating portion 6 made of an inorganic solid insulating material can be filled between the first emitting electrode 1 and the first intermediate electrode 2, and a second insulating portion 7 made of an inorganic solid insulating material can be filled between the second emitting electrode 3 and the second intermediate electrode 4. Furthermore, 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 portion 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 portion 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.

[0035] In a second specific embodiment, Figure 3 to Figure 4As shown, the first intermediate electrode 2 and the second intermediate electrode 4 are an integrated structure and constitute the second electrode body 8. The second electrode body 8 made of conductive material is provided with a first circular through cavity 9 and a second circular through cavity 10 with the same inner diameter. The first emitting electrode 1 is evenly spaced in the first circular through cavity 9, and the second emitting electrode 3 is evenly spaced in the second circular through cavity 10. At this time: the first intermediate electrode 2 is composed of the first circular through cavity 9 and the intersection of the first circular through cavity 9 and the outer surface of the second electrode body 8, and the discharge end face of the first intermediate electrode 2 is the intersection of the first circular through cavity 9 and the outer surface of the second electrode body 8; the second intermediate electrode 4 is composed of the second circular through cavity 10 and the intersection of the second circular through cavity 10 and the outer surface of the second electrode body 8, and the discharge end face of the second intermediate electrode 4 is the intersection 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 implementation of this embodiment, the first circular through cavity 9 and the second circular through cavity 10 can be filled with a first insulating portion and a second insulating portion made of an inorganic solid insulating material, respectively. 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 portion 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 portion 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. Figure 3 and Figure 4 In the illustrated embodiment, the multi-head shock wave electrode structure of the present application is provided with two fifth through cavities 11 to serve as an inflow cavity for the conductive fluid and an outflow cavity for the conductive fluid.

[0036] The third specific implementation example Figure 5 As shown, the discharge end face of the first emitting electrode 1 and the discharge end face of the first intermediate electrode 2 are located in the same plane, the discharge end face of the second emitting electrode 3 and the discharge end face of the second intermediate electrode 4 are located in the same plane, but the distal end face of the multi-head shock wave electrode structure is not a plane, which can effectively reduce the passing dimension of the multi-head shock wave electrode structure, and the shock waves released by the first discharge unit and the second discharge unit have a larger distribution range in space, which is suitable for the situation where the passing space to reach the tissue to be treated is narrow and the distribution range of the tissue to be treated is larger.

[0037] In the first specific embodiment, the second specific embodiment and the third specific embodiment, when one of the first emitting electrode 1 and the second emitting electrode 3 is a positive electrode, the other is a negative electrode. Since the ablation speed of the positive electrode is faster during discharge breakdown, the emitting electrode as the positive electrode can use an electrode material with a higher melting point, and the service life of the multi-head shock wave electrode structure of the present application can also be extended by exchanging the positive and negative electrodes during the discharge process. For example, the positive and negative electrodes are exchanged once for 100 shock waves. That is, when the shock waves are released for the first 100 times, the first emitting electrode 1 is the positive electrode and the second emitting electrode 3 is the negative electrode; when the shock waves are released for the last 100 times, the first emitting electrode 1 is the negative electrode and the second emitting electrode 3 is the positive electrode. Implementing a positive and negative electrode exchange strategy, that is, alternating the polarity of the electrodes after each group of fixed number of shock wave releases, can balance the ablation rate, extend the service life, and improve the discharge efficiency and reliability of the equipment.

[0038] In another embodiment suitable for practical use, 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 of a cylindrical structure and a third intermediate electrode 13 evenly spaced on the outer circumference of the third emitting electrode 12; the fourth discharge unit includes a fourth emitting electrode 14 of a cylindrical structure and a fourth intermediate electrode 15 evenly spaced on the outer circumference of the fourth emitting electrode 14; the fifth discharge unit includes a fifth emitting electrode 16 of a cylindrical structure and a fifth intermediate electrode 17 evenly spaced 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.

[0039] In the fourth specific embodiment, a third electrode body 18 made of insulating material is disposed outside the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17. The third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are cylindrical structures with equal inner diameters and equal outer diameters. The third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 may be in contact with each other. Alternatively, Figures 6 to 8As shown, any two of the third middle electrode 13, the fourth middle electrode 15 and the fifth middle electrode 17 are spaced apart from each other and electrically connected, and can be connected by wires or have 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 energy of the shock wave formed by the third discharge unit, the single energy of the shock wave formed by the fourth discharge unit and the single energy of the shock wave formed by the fifth discharge unit are equal. In a preferred implementation of this embodiment, a third insulating portion 19 made of an inorganic solid insulating material can be filled between the third emitting electrode 12 and the third middle electrode 13, a fourth insulating portion 20 made of an inorganic solid insulating material can be filled between the fourth emitting electrode 14 and the fourth middle electrode 15, and a fifth insulating portion 21 made of an inorganic solid insulating material can be filled between the fifth emitting electrode 16 and the fifth middle electrode 17. Further, the discharge end surface of the third emitting electrode 12, the discharge end surface of the third intermediate electrode 13 and the outer surface of the third insulating portion 19 constitute the outer surface of the third discharge unit, the discharge end surface of the fourth emitting electrode 14, the discharge end surface of the fourth intermediate electrode 15 and the outer surface of the fourth insulating portion 20 constitute the outer surface of the fourth discharge unit, the discharge end surface of the fifth emitting electrode 16, the discharge end surface of the fifth intermediate electrode 17 and the outer surface of the fifth insulating portion 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. Three sixth through cavities 22 may be further provided.

[0040] In the fifth specific embodiment, the third intermediate electrode 13, the fourth intermediate electrode 15 and the fifth intermediate electrode 17 are an integrated structure and constitute a fourth electrode body, and the fourth electrode body is provided with a third circular through cavity, a fourth circular through cavity and a fifth circular through cavity with equal radius, the third emitting electrode 12 is evenly spaced in the third circular through cavity, the fourth emitting electrode 14 is evenly spaced in the fourth circular through cavity, and the fifth emitting electrode 16 is evenly spaced in the fifth circular through cavity. At this time: the third intermediate electrode 13 is composed of the third circular through cavity and the intersection 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 intersection 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 intersection 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 intersection 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 intersection 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 intersection of the fifth circular through cavity and the outer surface of the fourth electrode body. Similarly, the third discharge unit, the fourth discharge unit and the fifth discharge unit are the same discharge units, and the single energy of the shock wave formed by the third discharge unit, the single energy of the shock wave formed by the fourth discharge unit and the single energy of the shock wave formed by the fifth discharge unit are equal. In a preferred implementation of this embodiment, the third circular through cavity, the fourth circular through cavity and the fifth circular through cavity may be filled with an insulating portion made of an inorganic solid insulating material. Those skilled in the art should be able to 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.

[0041] In the fourth specific embodiment and the fifth specific embodiment, a third emitting electrode 13, a fourth emitting electrode 15 and a fifth emitting electrode 17 are provided, two of which are selected each time as the positive and negative electrodes for discharge breakdown, and the polarity of the electrodes is alternated after releasing the shock wave for each fixed number of times, which can effectively balance the ablation rate, greatly extend the service life, and effectively improve the discharge efficiency and reliability of the equipment.

[0042] In the aforementioned five specific embodiments, the emitting electrodes are evenly spaced within the corresponding intermediate electrodes, so when the implementation voltage and the ablation of the emitting electrodes permit, the emitting electrodes can discharge and break down between the entire inner circumference of the corresponding intermediate electrodes to release shock waves, thereby effectively increasing the number of effective shock waves that can be generated by the multi-head shock wave electrode structure of the present application and increasing the service life of the multi-head shock wave electrode structure of the present application.

[0043] From the above, it can be seen that the multi-head shock wave electrode structure of the present application is also suitable for being arranged on its side circumferential surface. At this time, the outer surface of the discharge unit (including the discharge end surface of the emitting electrode and the discharge end surface of the intermediate electrode, and may also include the outer surface of the insulating part) is located on the same arc surface.

[0044] The embodiment of the present invention also provides a shock wave balloon catheter, comprising the multi-head shock wave electrode structure as described above, a tube body and an expansion element capable of being filled with a conductive fluid; the expansion element is sealed and connected to the distal end of the tube body, and the discharge end faces of all the emitting electrodes and the discharge end faces of all the intermediate electrodes of the multi-head shock wave electrode structure are located in the expansion element; when the expansion element is filled with a conductive fluid and a potential difference is formed between any two emitting electrodes of the multi-head shock wave electrode structure, the discharge end faces of the two emitting electrodes forming the potential difference respectively induce shock waves simultaneously with the discharge end faces of the corresponding intermediate electrodes. The tube body includes a catheter body that enters the human body and other external parts, and the other external parts include, for example, a handle, a side branch, and other circuit interfaces and fluid circuit interfaces.

[0045] In the process of forming shock waves by using the liquid-electric method, small bubbles will be formed on the discharge end face of the emitting electrode and the discharge end face of the intermediate electrode. The small bubbles that are not handled in time will also form large bubbles in the conductive fluid. If the large bubbles are not handled in time, they will slowly move to the inner wall of the expansion element. The small bubbles accumulated on the discharge surface will affect the conductive properties of the conductive fluid, and then affect the discharge breakdown between the discharge end face of the emitting electrode and the discharge end face of the intermediate electrode. The large bubbles in the conductive fluid will affect the intensity of the shock wave (the size of the shock wave energy) during the shock wave transmission process. At the same time, both large bubbles and small bubbles will scatter the shock wave energy and weaken the shock wave energy. For this reason, the shock wave balloon catheter of the present application is further provided with a circulation system of the conductive fluid, so that the conductive fluid can flow during the discharge breakdown process, so that the large bubbles and small bubbles can be taken away by the flowing conductive fluid.

[0046] In the first embodiment, 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 in the expansion 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 cavity arranged near the emitting electrode and the intermediate electrode (such as the fifth through cavity 11 and the sixth through cavity 22 mentioned above) can be used as the inflow cavity of the conductive fluid and the outflow cavity of the conductive fluid. The conductive fluid enters from the inflow cavity and is discharged through the outflow cavity, and large bubbles can be taken away with the flow of the conductive fluid. Since the inflow cavity and the outflow cavity are close to the emitting electrode and the intermediate electrode, the conductive fluid can flush the discharge end surface of the emitting electrode and the discharge end surface of the intermediate electrode, and can effectively take away small bubbles.

[0047] 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 expansion element. As the conductive fluid flows, large and small bubbles can be taken away.

[0048] In a third embodiment, the multi-head shock wave electrode structure includes 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 third through cavities and the distal openings of all fourth through cavities are located in the expansion 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 cavity arranged near the transmitting electrode and the middle electrode can be used as an inflow cavity and an outflow cavity of the conductive fluid, and is preferably used as an inflow cavity of the conductive fluid. The fourth through cavity can be used as an inflow cavity and an outflow cavity of the conductive fluid, and is preferably used as an outflow cavity of the conductive fluid. When the third through cavity arranged near the transmitting electrode and the middle electrode is used as an inflow cavity of the conductive fluid, and the fourth through cavity is used as an 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 middle electrode to the outflow cavity located in the tube body, and has a longer flow distance, so the conductive fluid can effectively take away large and small bubbles.

[0049] As can be seen from the above, the multi-head shock wave electrode structure of the present application solves the problem of damage to the electrode structure caused by the large mechanical impact force formed by the large shock wave energy while achieving a single effective discharge breakdown to form a large shock wave energy, thereby solving the problem that the prior art cannot use shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand, and achieves the purpose of using only shock wave energy to treat hardened tissues in parts that cannot or are inconvenient to expand without the help of expansion, so that these hardened tissues are softened and some tissue functions are restored. At the same time, the multi-head shock wave electrode structure of the present application also has a large number of effective shock wave initiation times and a long service life.

[0050] The above is only a specific implementation of the present application, but the protection scope of the present application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in the present application should be included in the protection scope of the present application. Therefore, the protection scope of the present application shall be based on the protection scope of the claims.

Claims

1. A multi-head shock wave electrode structure, characterized in that: Applied inside the balloon, the multi-head shock wave electrode structure includes: at least two discharge units; each discharge unit includes an emitting electrode and a corresponding intermediate electrode which are arranged at intervals and have the same extension direction, and the emitting electrodes are arranged in the intermediate electrode at intervals one by one; all the intermediate electrodes are electrically connected to each other; when the discharge end surfaces of all the intermediate electrodes and the discharge end surfaces of all the emitting electrodes are located in the conductive fluid and a potential difference is formed between the emitting electrodes of any two discharge units, shock waves are simultaneously generated between the discharge end surfaces of the emitting electrodes of the two discharge units and the discharge end surfaces of the corresponding intermediate electrodes.

2. The multi-head shock wave electrode structure according to claim 1, characterized in that: It comprises a main body structure made of insulating material; all the middle electrodes are in contact with each other, or all the middle electrodes are arranged in pairs and electrically connected.

3. The multi-head shock wave electrode structure according to claim 1, characterized in that: All the intermediate electrodes are an integrated structure and constitute an electrode body, which is provided with at least two through cavities, the extension direction of the through cavities is the same as that of the emitting electrodes, and the emitting electrodes are sleeved in the through cavities one by one.

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

5. The multi-head shock wave electrode structure according to any one of claims 1 to 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 evenly 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 evenly spaced and sleeved on the outer circumference of the second emitting electrode, and the outer diameters of the second emitting electrode and the first emitting electrode are the same.

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

7. The multi-head shock wave electrode structure according to any one of claims 1 to 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 third emitting electrode with a cylindrical structure and a third intermediate electrode evenly spaced on the outer circumference of the third emitting electrode; the fourth discharge unit includes a fourth emitting electrode with a cylindrical structure and a fourth intermediate electrode evenly spaced on the outer circumference of the fourth emitting electrode; the fifth discharge unit includes a fifth emitting electrode with a cylindrical structure and a fifth intermediate electrode evenly spaced on the outer circumference of the fifth emitting electrode; the outer diameters of the third emitting electrode, the fourth emitting electrode and the fifth emitting electrode are equal.

8. The multi-head shock wave electrode structure according to claim 7, characterized in that: A third electrode body made of insulating material is disposed outside the third intermediate electrode, the fourth intermediate electrode and the fifth intermediate electrode, and the third intermediate electrode, the fourth intermediate electrode and the fifth intermediate electrode are cylindrical structures with equal inner diameters and equal outer diameters; the third intermediate electrode, the fourth intermediate electrode and the fifth intermediate electrode are in contact with each other, or the third intermediate electrode, the fourth intermediate electrode and the fifth intermediate electrode are spaced apart from each other and electrically connected; or, The third intermediate electrode, the fourth intermediate electrode and the fifth intermediate electrode are an integrated structure and constitute the fourth electrode body. The fourth electrode body is provided with a third circular through cavity, a fourth circular through cavity and a fifth circular through cavity with equal radius. The third emitting electrode is evenly spaced in the third circular through cavity, the fourth emitting electrode is evenly spaced in the fourth circular through cavity, and the fifth emitting electrode is evenly spaced in the fifth circular through cavity.

9. A shock wave balloon catheter, characterized in that: include: A multi-head shock wave electrode structure, a tube body and an expansion element capable of being filled with a conductive fluid as claimed in any one of claims 1 to 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 the discharge end faces of all intermediate electrodes of the multi-head shock wave electrode structure are located within the expansion element; when the expansion element is filled with a 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 induced between the discharge end faces of the two emitting electrodes forming the potential difference and the discharge end faces of their respective corresponding intermediate electrodes.

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

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