Shock wave electrode device and shock wave catheter system

Abstract

The present invention provides a shock wave electrode device and a shock wave catheter system. The shock wave electrode device includes a flexible printed wiring board and an electrode assembly. The flexible printed wiring board includes a flexible substrate, a conductive pattern layer, and a coating layer. The electrode assembly is integrated on the conductive pattern layer of the flexible printed wiring board or on its surface. The electrode assembly includes at least a pair of positive and negative electrodes with an electrode gap between the positive and negative electrodes. The electrode assembly and a part or all of the electrode gap are exposed on the surface of the flexible printed wiring board. The shock wave catheter system provided by the present invention uses this shock wave electrode device. The shock wave catheter system manufactured using the shock wave electrode device provided by the present invention has the advantages of miniaturization and integration, and can improve the shock wave performance and stability of the catheter, and can simplify the catheter production and manufacturing process, increase productivity, and reduce production costs.

Description

[Technical field]

[0001] The present invention relates to the technical field of medical equipment, in particular to a shockwave electrode device and a shockwave catheter system. [Background technology]

[0002] Electrodes are components connected to both ends of a conductive dielectric (including solid, liquid, gas, plasma, or vacuum) to allow charge to flow into the dielectric and / or flow out through the dielectric. An electrode can be made of metal or nonmetal and can be an electrode if it can exchange charge with the dielectric. Electrodes are divided into positive and negative electrodes. Positive and negative electrodes generally appear in pairs, and a pair of positive and negative electrodes connected to the same circuit may be collectively called electrodes. Under certain conditions, a large amount of charge accumulates at both ends of the positive and negative electrodes to generate a strong electric field. Neutral particles in the medium between the electrodes are ionized into plasma under the action of a strong electric field, and a discharge phenomenon occurs. The rapid temperature change of the plasma and surrounding medium generated during the discharge process results in rapid volume expansion and contraction of the surrounding medium. Such violent movement of particles in the medium generates pressure sound waves. The pressure sound waves are transmitted to the outside through the medium. When the speed of the particle movement exceeds the propagation speed of sound waves in the medium, a shock wave is generated. In particular, when the medium between the electrodes is a liquid, the cavitation effect occurs when the enormous energy in the plasma channel causes the surrounding liquid to rapidly vaporize and form bubbles, which then expand and burst rapidly, accelerating the motion of particles in the medium and generating powerful shock waves. This phenomenon is called the liquid-electric effect.

[0003] As one of the main methods of generating shock waves, the liquid electric effect has the advantages of large impact energy, high energy efficiency, fast propagation speed, wide frequency range, etc., and is widely applied. Liquid electric shock wave lithotripsy is a technology that generates high-intensity shock waves based on the principle of liquid electric effect to break hard stones, and is applied in the fields of processing, mining, medicine, etc. Based on a similar principle, a new percutaneous puncture angioplasty has been used in recent years to treat calcified stenosis of blood vessels (Chinese Patent No. CN10458297B discloses a shock wave balloon catheter with multiple shock wave sources, which includes a balloon that can be filled with a liquid medium and an electrode assembly that can emit shock waves). Such a catheter usually has one or more sets of electrode units arranged inside the balloon, and is connected to an external high-pressure circuit through the catheter by one or more wires. After the balloon fills the narrowed portion of the blood vessel, a pulse voltage is input to the electrodes via the wires to form liquid electricity, generating radial shock waves to disrupt the calcifications in the intima and media of the blood vessel, thereby achieving the effect of vasodilation. Summary of the Invention [Problem to be solved by the invention]

[0004] The current products and technologies have problems such as a large number of electrode parts, complicated manufacturing technology, poor dimensional accuracy, complicated electrode assembly production process, low automation level, inaccurate electrode gap, dense wiring of component devices, difficult integration and positioning, long processing time, low product yield rate, etc. Finally, such catheters generally have defects such as high production cost and poor shock wave consistency, and the catheters are too large and soft, with poor physical properties and vascular passability, so that the adaptability of blood vessels, the efficacy of decalcification and the safety of products still face challenges, which limits the further application of this technology in the field of angioplasty. [Means for solving the problem]

[0005] In view of this, the present invention aims to provide a shock wave electrode device that has features such as small size, high precision, simple manufacturing process, high production efficiency, and easy assembly, while at the same time having good shock wave performance and low production costs.

[0006] The present invention provides a shock wave electrode device, which comprises: A flexible printed wiring board and an electrode assembly are provided. The flexible printed wiring board includes a flexible substrate made of a single or multiple laminated insulating materials, a conductive pattern layer made of printed conductors located on a surface of the flexible substrate, and / or a covering layer made of an insulating material and covering a surface of the flexible printed wiring board, the electrode assembly is integrated on the conductive pattern layer inside the flexible printed wiring board or on a surface of the flexible printed wiring board, and includes at least a pair of positive and negative electrodes; Each pair of positive and negative electrodes has an electrode gap between the positive and negative electrodes, The flexible substrate and / or the covering layer have through openings formed in all of the electrode gaps in the flexible printed wiring board, exposing the electrode assembly and some or all of the electrode gaps to the surface of the flexible printed wiring board.

[0007] Optionally, the flexible printed circuit board is a single layer board, a double-sided board, a multi-layer board or a soft board part of a flexible-hard combined board.

[0008] Optionally, to increase lamination strength, the flexible substrate, the conductive pattern layer and the covering layer are connected to each other by a crimping process, and the flexible substrate, the conductive pattern layer and the covering layer are fixed to each other by an adhesive.

[0009] Optionally, an electromagnetic shielding film is applied on the surface of the covering layer to improve the electromagnetic interference capability, and a back rubber is pre-applied on the bottom surface of the flexible printed wiring board to improve the fixing strength.

[0010] Optionally, the insulating material of the flexible substrate and / or the cover layer comprises at least one or more of polyimide, polyethylene terephthalate, polyether ether ketone, aramid fiber ester, polyvinyl chloride and polytetrafluoroethylene.

[0011] Optionally, the electrode assembly may be printed and integrated onto the conductive pattern layer of the flexible printed wiring board by one or more combinations of etching, deposition, rolling or electrolytic processes, or conductive members may be integrated onto the surface of the flexible printed wiring board via one or more combinations of patching, welding or crimping processes.

[0012] Optionally, depending on the application scene and size specifications, multiple pairs of the positive and negative electrodes are connected in series, parallel or mixed arrangement via the printed conductors.

[0013] Optionally, the shockwave electrode device further comprises a reinforcement device; The reinforcing device is a pre-integrated structure of the flexible printed wiring board or an independent structure integrated into the flexible printed wiring board; The reinforcing device is located on the surface or between the inner pressure-bonding layers of the flexible printed wiring board, and the material of the reinforcing device includes at least one or more of the following: Organic polymeric materials, and / or Inorganic non-metallic materials, and / or metal.

[0014] The present invention further provides a shock wave catheter system, comprising: a catheter including a proximal catheter section and a distal catheter section extending axially to a distal end; An independent chamber; A shock wave electrode device according to any one of claims 1 to 7, a catheter joint; the catheter includes at least one independent channel extending from the proximal catheter section to the distal catheter section; the independent chamber is formed by an expandable capsule structure located in the outer space of the distal catheter portion and at least one of the independent channels; a proximal side of the independent channel extends axially from the proximal catheter section and is connected to the capsule structure, an interior space of the independent channel combining with a hollow portion of the capsule structure to form an independent expandable chamber; The independent chamber is used to fill and store a liquid medium and isolate it from human tissue and blood, and the independent chamber is capable of withstanding a relative pressure of at least one standard atmospheric pressure of the liquid medium to prevent leakage of the liquid medium or rupture of the independent chamber; the shockwave electrode device is located within the independent chamber, the electrode assembly is located within the independent chamber near the distal catheter section, and the flexible printed wiring board of the shockwave electrode device extends through the independent channel to the proximal catheter section of the catheter; the catheter joint is connected to the proximal catheter section, and at least one channel of the catheter joint is connected to the independent chamber for transferring the liquid medium; The printed wires of the shockwave electrode device provide an energy transmission path through at least one channel of the catheter joint.

[0015] Optionally, the positive and negative electrodes of the electrode assembly are arranged within the independent chambers along the circumferential and / or axial direction of the catheter to form one or more electrode gaps distributed in the circumferential and / or axial directions.

[0016] Optionally, the geometry of the arrangement of the electrode gaps within the independent chamber includes one or more of a polygon, annular, arcuate, and surround.

[0017] Optionally, the material of construction of the catheter and capsule is one or a mixture of thermoplastic polymer compounds, silica gel, rubber and polymeric fiber compounds.

[0018] Optionally, the liquid medium is a mixture of at least one or more of saline, a contrast agent, and / or water for injection.

[0019] Optionally, the catheter further comprises an extension lead; The start end of the extension lead is connected to the printed conductor of the shockwave electrode device; the extension lead extends through the energy transmission passage of the catheter joint to the exterior of the catheter; The distal end of the extension lead is connected to an external energy generator or control handle.

[0020] Optionally, the catheter further comprises a high voltage electrical plug connected to the energy transmission passage of the catheter joint; The flexible printed wiring board or the extension lead communicates with the external energy generator or the control handle via the high voltage electrical plug to realize energy transmission.

[0021] Optionally, the shockwave catheter system further comprises a development ring; The development ring is fixed within the distal catheter portion or the capsule structure and serves as a development mark under X-ray of the working area of ​​the capsule structure.

[0022] Optionally, the development ring is provided to enclose an outer surface of the flexible printed wiring board and is used to fix the electrode assembly and the flexible printed wiring board.

[0023] Optionally, a secondary support structure is further provided within the independent chamber; The shock wave electrode device is fixed inside the independent chamber by the auxiliary support structure; The auxiliary support structure may be any one or combination of a support tube, a stent, a balloon, and a probe.

[0024] Optionally, the auxiliary support structure may expand, open or move within the capsule structure to provide the ability to adjust the position of the electrode assembly.

[0025] Optionally, the shockwave catheter system further comprises a micro-element integrated inside the flexible printed circuit board in the manner of a printed circuit or integrated on the surface of the flexible printed circuit board in the manner of a chip-on-film package.

[0026] Optionally, the microdevice comprises at least one or more of the following: Sensing element and / or Therapeutic elements and / or Image sensor. Effect of the Invention

[0027] By using the flexible printed circuit board, the complicated components and arrangement of the traditional intravascular shock wave generator, such as wires and electrodes, are replaced, and the miniaturization and integration of the liquid electrostatic generating electrodes are realized, the manufacturing difficulty of the liquid electrostatic electrodes is reduced, the density of the liquid electrostatic electrodes is increased, and the uniformity of the discharge energy is improved. The shock wave electrode device using this type of liquid electrostatic electrodes has the advantages of accurately controlling the gap between each electrode, accurately positioning each electrode, high discharge stability, and balanced and controllable shock wave energy. At the same time, the components such as electrodes, wires, electrodes and microelements are integrated on the flexible printed circuit board, which avoids the problems of inaccurate positioning between them, insufficient insulation, and weak connection, and also greatly reduces the connection work between each component, which simplifies the production and manufacturing process of the shock wave discharge electrode device, and has the advantages of being easy to install. The shock wave catheter system made using the shock wave electrode device provided by the present invention has the advantages of miniaturization and integration, while at the same time improving the shock wave performance and stability of the catheter, and simplifying the catheter production and manufacturing process, thereby increasing productivity and reducing production costs. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a schematic plan view of a shockwave electrode device provided by the present invention. [Diagram 2] FIG. 1 is a schematic cross-sectional view of a shockwave electrode device provided by the present invention. [Diagram 3] 2 is a schematic cross-sectional view of each electrode assembly in a rotational state of the shock wave electrode device provided by the present invention. FIG. [Figure 4] 2 is a schematic cross-sectional view of each electrode assembly in a rotational state of the shock wave electrode device provided by the present invention. FIG. [Diagram 5] 2 is a schematic cross-sectional view of each electrode assembly in a rotational state of the shock wave electrode device provided by the present invention. FIG. [Figure 6] FIG. 2 is a schematic plan view of another shockwave electrode device provided by the present invention. [Figure 7] FIG. 2 is a schematic plan view of another shockwave electrode device provided by the present invention. [Figure 8] FIG. 13 shows another shock wave electrode device provided by the present invention surrounding a cylindrical catheter. [Figure 9] 1 is a schematic plan view of a shock wave catheter system provided by the present invention. FIG. [Figure 10] FIG. 2 is a schematic cross-sectional view of the electrode assembly CC of the shock wave catheter system provided by the present invention. [Figure 11] FIG. 1 is a schematic diagram of another connection scheme between the shockwave catheter system provided by the present invention and an external energy generator or its control handle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Hereinafter, the embodiments of the present invention will be described with reference to specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed herein.

[0030] In the following description, reference is made to the accompanying drawings, which illustrate several embodiments of the present invention. It is understood that other embodiments may be used, and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present invention. The following detailed description should not be considered as limiting. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the present invention.

[0031] In some instances, terms such as first, second, etc. are used herein to describe various components, but these components should not be limited by these terms, these terms are used only to distinguish one component from another component.

[0032] Furthermore, as used herein, the singular forms "one", "one" and "which" are intended to include the plural, unless the context indicates to the contrary. Furthermore, it is to be understood that the terms "comprise" and "comprise" mean the presence of a feature, step, operation, component, assembly, item, type, and / or group, but do not exclude the presence, occurrence or addition of one or more other features, steps, operations, components, assemblies, items, types, and / or groups. The terms "or" and "and / or" as used herein are to be interpreted as being inclusive, or meaning any one, any combination. Thus, "A, B or C" or "A, B and / or C" means either "A, B, C", "A and B", "A and C", "B and C", or "A, B and C". Exceptions to this definition occur only when a combination of components, features, steps, or operations are inherently mutually repelling in some aspect.

[0033] The present invention describes a shockwave electrode device and shockwave catheter system mainly based on a flexible printed circuit board, and the related embodiments are typically used in the fields of angioplasty, valvuloplasty, etc., to impact, loosen, or break up plaque and calcified tissue in blood vessels and heart valves. However, it is expected that the device can also be used in other treatment locations and applications. In some embodiments of the present invention, the target tissue of the shockwave electrode device and shockwave catheter system can be vessel wall plaque and calcified tissue in coronary, peripheral, and intracranial vessels. In other embodiments, the target tissue can be plaque and calcified tissue in heart valves. In other embodiments, the target tissue can be stones or other intraluminal obstructions in the urinary, digestive, and respiratory systems, etc.

[0034] <First Example> The structural configuration, characteristic elements and basic principle of the present invention will be described below by taking a simple and typical shock wave electrode device based on a flexible printed circuit board as an example.

[0035] A plan view of the shock wave electrode device according to this embodiment is as shown in FIG. 1. This shock wave electrode device 11 includes a flexible printed wiring board 12, an electrode assembly 13 integrated on the flexible printed wiring board, and a printed conductor 14. The electrode assembly 13 includes at least one pair of positive and negative electrodes, for example, a total of six pairs of positive and negative electrodes located at AA, BB, and CC locations, and an electrode gap 15 with a specific pitch exists between each pair of positive and negative electrodes. This pitch is defined as the minimum value of the distance between each pair of positive and negative electrodes in the electrode assembly 13. A cover layer 16 (shown as a diagonal shaded area in FIG. 1) covers the upper surface of the flexible printed wiring board 12, and an opening 17 (rounded rectangle in the drawing) is formed in the electrode gap 15, exposing the electrode gap 15 and a part or all of the electrode assembly 13 to the surface of the flexible printed wiring board 12.

[0036] FIG. 2 is a cross-sectional view taken along line AA of the shock wave electrode device of FIG. 1. As shown in FIG. 2, the flexible printed wiring board 12 includes a single or multiple laminated flexible substrate 21 made of an insulating material, a conductive pattern layer 22 (including an integrated electrode assembly 13 and a printed conductor 14), and / or a covering layer 16 and an adhesive 23 that cover the surface of the flexible printed wiring board made of an insulating material. The flexible printed wiring board 12 is a single-layer board, a double-sided board, a multi-layer board, or a soft board part of a hard-soft combined board. Hereinafter, an example will be described in which the flexible printed wiring board 12 has a single-layer board structure. The flexible substrate 21 is a flexible insulating film made of a polymer insulating material such as polyimide, PET, or polyether ether ketone. The electrode assembly 13 and the printed conductor 14 are printed on the upper surface of the flexible substrate 21 by processes such as etching, deposition, and pressure bonding. The covering layer 16 is covered on the upper surface of the flexible substrate 21 on which the electrode assembly 13 and the printed conductor 14 are integrated. An adhesive 23 is applied between the flexible substrate 21 and the covering layer 16 to increase the lamination strength.

[0037] When the shock wave electrode device is placed in a liquid medium, the liquid medium is injected into the electrode gap 15 through the opening 17 in the cover layer 16. At this time, when a high voltage current flows through the positive and negative electrodes of the electrode assembly 13 via the printed conductor wire 14, a high intensity electric field is formed between the positive and negative electrodes, which causes the liquid medium in the electrode gap 15 to be ionized and cavitated, forming a liquid electric effect and generating shock waves.

[0038] The manufacturing method of the flexible printed wiring board 12 in this embodiment is to print the electrode assembly 13 on the surface of the flexible substrate 21 at the same time as the printed conductor 14, and then fabricate the flexible printed wiring board 12. In this case, the electrode assembly 13 is integrated into the conductive pattern layer 22 of the flexible printed wiring board 12. In a sense, the electrode assembly 13 in this case can be considered as an extension of the end of the printed conductor 14. However, since the opening 17 of the covering layer 16 necessarily exposes at least a part of the electrode assembly 13 on the surface of the flexible printed wiring board 12, and the electrode assembly 13 has a typical structural form of an electrode pair and an electrode gap 15, the above method can clearly distinguish whether the printed circuit of any segment is the electrode assembly 13 or the printed conductor 14.

[0039] In some other embodiments, when manufacturing the flexible printed wiring board 12, the electrode assembly 13 and optional pin contacts of other microelements are printed on the surface of the printed conductor 14 and the flexible substrate 21 to prepare an initial mold of the flexible printed wiring board 12, and then the electrode assembly 13 and optional other microelements are integrated on the surface of the initial mold using a process such as patching, welding or crimping, thereby finally preparing the flexible printed wiring board 12 having the electrode assembly 13. In this case, the electrode assembly 13 is usually located on the surface of the flexible printed wiring board 12.

[0040] The above two methods or variations and combinations of the methods can be used as a general method for manufacturing the shock wave electrode device 11, and the corresponding optimal manufacturing method is selected in consideration of different application scenes and limitations. For example, in situations where the requirement for electrode miniaturization is relatively high, the method described in this embodiment is preferred, but in situations where high shock wave energy and long electrode life are required, the second method is preferred.

[0041] In general, the width of the electrode gap 15 is usually 0.025 mm to 2.5 mm, for example, 0.05 mm, 0.1 mm, 0.12 mm, 0.15 mm, 0.18 mm, etc. On the other hand, the standard width of the electrode gap 15 in this embodiment is 0.2 mm.

[0042] For example, the surface of the covering layer 16 of the flexible printed wiring board 12 may be coated with an electromagnetic shielding film, and the bottom surface of the flexible printed wiring board 12 may be pre-coated with a back rubber.

[0043] 3 to 5 are supplementary to FIG. 1 and FIG. 2, and show the peripheral cross-sectional views of the shock wave electrode device described in the embodiment at the electrode positions AA, BB, and CC. This case can be understood as an example in which the shock wave electrode device is attached and fixed to the auxiliary support structure. In this embodiment, the auxiliary support structure is a cylindrical support tube 31 (corresponding to a catheter as described below). To simplify the process, the adhesive 23 in FIG. 2 is not drawn in FIG. 3, but this case does not apply to the adhesive 23 that may be present in some other embodiments, and also matches the situation in which the flexible substrate 21 and the covering layer 16 are directly laminated.

[0044] It should be particularly pointed out that the flexible printed wiring board 12 can also be designed into any closed shape consisting of line segments, arc lines, etc. The shape of the flexible printed wiring board 12 is preferably such that it can carry the electrode assembly 13, the printed conductor wire 14, and the covering layer 16. The specific shape of the flexible printed wiring board 12 should correspond to the specific design situation of the shock wave electrode device 11, which will not be described further. In addition, since the flexible printed wiring board 12 has the basic characteristics of being flexible and bendable, the shock wave electrode device 11 described in the present invention can be attached to the surface of an auxiliary support structure of any shape and can follow the shape of this structure. The examples of the external shape of the auxiliary support structure in this embodiment and other embodiments of the present invention cannot constitute a restriction on the structure and external shape of the shock wave electrode device 11 and the auxiliary support structure described in the present invention.

[0045] <Second Example> Based on the above embodiment, the structure, characteristic elements and basic principle of the shock wave electrode device of the present invention will be described. This embodiment provides a shock wave electrode device based on a flexible printed wiring board with more engineering value. Compared with the first embodiment, this embodiment has the same material composition of the flexible printed wiring board 12 and the same controlled width of the electrode gap 15, so only the structural characteristics of some typical specifications of this embodiment will be described in detail.

[0046] The flexible printed wiring board 12 of the shock wave electrode device 11 according to this embodiment is composed of one single-layer flexible substrate 21 and two conductive pattern layers 22 located on the upper and lower surfaces of the flexible substrate 21. The electrode assembly 13 and some of the printed conductors 14 are integrated in the conductive pattern layer 22 on the upper surface of the flexible substrate 21, and the conductive pattern layer 22 on the lower surface of the flexible substrate 21 is the printed conductors 14 that realize the conduction of the circuit. The covering layer 16 covers the surface of the flexible substrate 21 on which the electrode assembly 13 and the printed conductors 14 are integrated, and an opening 17 is formed in the electrode gap 15, exposing the electrode gap 15 and some of the electrode assembly 13 to the surface of the flexible printed wiring board 12. The front plan view of the shock wave electrode device 11 of the typical specifications in this embodiment is as shown in FIG. 6.

[0047] 6, the electrode assembly 13 of the shock wave electrode device 11 of the present invention is composed of five groups of parallel positive and negative electrode pairs located at AA, BB, CC, DD, and EE of the shock wave electrode device 11, and the positive and negative electrode pairs of each group are connected in series by four pairs of uniformly distributed positive and negative electrode pairs to form four uniformly distributed electrode gaps 15. If the direction along ABCDE of the shock wave electrode device 11 is defined as the longitudinal direction, the shock wave electrode device 11 rotates symmetrically along the longitudinal direction so that the head and tail of each point from AA to EE are in contact with each other, the four electrode gaps 15 can be uniformly distributed in the circumferential direction at an angle of 90°.

[0048] As shown in Fig. 7, the developed rear view (bottom view) of the shock wave electrode device 11 described above shows that the conductive pattern layer 22 on the rear side is composed of printed conductors 14, and its main role is to connect the electrodes and ensure the conduction of the electrode circuit. The hollow circular holes that appear in the same positions in Fig. 6 and Fig. 7 are via holes 41 for connecting the printed conductors 14 of the upper and lower conductive pattern layers 22 and forming a conductive circuit.

[0049] For example, the shock wave electrode device 11 of this embodiment has a total of 20 positive and negative electrodes and corresponding 20 electrode gaps 15. Since an opening is formed in each electrode gap 15 in the covering layer 16, the shock wave electrode device 11 has a total of 20 shock wave generation points under the liquid electric effect.

[0050] When the shock wave electrode device described in this embodiment is applied to a shock wave catheter system, the shock wave electrode device 11 must surround the cylindrical catheter 31 as shown in FIG. 8. In this typical specification of this embodiment, the shock wave electrode device 11 can be joined at the head and tail of each point from AA to EE in a circumferential state along the longitudinal direction, that is, it can completely cover the surface of the cylindrical catheter 31. At this time, the four electrode gaps 15 at each point are arranged in the circumferential direction of the catheter 31. Generally, in the shock wave electrode device 11 of the other specification described in this embodiment, when the number of electrode pairs of the same cross section is two pairs, the two electrode gaps 15 are distributed at intervals of 180° in the circumferential direction of the catheter 31, while when the number of electrode gaps 15 of the same cross section is three, the electrode gaps 15 are distributed at intervals of 120° in the circumferential direction of the catheter 31, and the like. The above spacing arrangement method allows the catheter 31 to maintain a balance of the force received when the electrode pairs are discharged.

[0051] Illustratively, this embodiment has a reinforcing device of an independent structure. The reinforcing device is a ring 51 made of metal. The inner diameter of the ring 51 is slightly larger than the diameter of the shock wave electrode device 11 when it is wrapped around the shock wave electrode device 11, so the ring 51 is fixed to the surface of the shock wave electrode device so as to surround it. The ring 51 has four openings 52 evenly distributed in the circumferential direction. Thus, in the sleeve joining state, each electrode gap 15 of the shock wave electrode device is aligned with the opening 52 of the ring 51, and the electrode gap 15 is effectively exposed. This design is used to reduce the mechanical impact on the flexible printed wiring board 12 caused by the shock waves generated by the electrode assembly 13, and to improve the reliability of the shock waves generated by the shock wave electrode device 11 and the shock wave catheter system, and to increase their service life. FIG. 8 shows a state in which some electrode assemblies 13 and electrode gaps 15 are surrounded by the ring 51 to better show the positional relationship between the electrode assemblies 13, the electrode gaps 15, and the ring 51. Here, the ring 51 is a ring 51 under a quarter section.

[0052] For example, after the shock wave electrode device 11 according to this embodiment is fitted to the catheter 31, the end of the flexible printed wiring board 12 is auxiliary fixed using a developing ring 54.

[0053] As for other specifications of this embodiment, the diameter size of the catheter 31, the configuration of the electrode assembly 13, and the number and arrangement method of the electrode gaps 15 need to be determined based on the actual scene, and may be one or more of polygon, ring, arc and surround, and this embodiment will not be further described.

[0054] <Third Example> This embodiment provides an example of a shock wave catheter system of the above-mentioned shock wave electrode device 11 based on the shock wave electrode device described in the second embodiment, and the example will be described in detail below.

[0055] As shown in FIG. 9, the shock wave catheter system according to this embodiment includes the shock wave electrode device 11, the catheter 31, the development ring 54, the balloon 61 and its independent channel 62, the independent cavity 63, the catheter joint 64, the extension lead 65, and the high voltage electric plug 66 as main components. The catheter 31 includes a proximal catheter portion on the proximal side and a distal catheter portion extending axially to the distal end. The balloon 61, which is an expandable capsule-type structure, is provided on the outer layer of the distal catheter portion of the catheter 31. The hollow portion of the balloon 61 and the independent channel 62 are combined to form an expandable independent cavity 63. The flexible printed wiring board 12 described above is disposed inside the independent cavity 63. When a liquid medium is injected into the independent cavity 63, the balloon 61 can withstand the relative pressure of at least one standard atmospheric pressure of the liquid medium, preventing leakage of the liquid medium and rupture of the balloon 61.

[0056] Exemplarily, the shock wave electrode device 11 is installed in an independent cavity 63 located at the distal catheter part of the catheter 31, and its flexible printed wiring board 12 extends to the proximal catheter part of the catheter 31 through the independent channel 62 described above. In a preferred embodiment, as described in the second embodiment, the shock wave electrode device 11 is integrated so as to surround the distal catheter part of the catheter 31 along the longitudinal direction and completely cover the surface of the cylindrical catheter 31. At that time, the electrode gaps 15 at each location are all arranged in the circumferential direction of the catheter 31. The method of attaching the shock wave electrode device 11 includes bonding, welding, caulking, stapling, snapping, etc. In this embodiment, the shock wave electrode device 11 is fixed to the catheter 31 by bonding.

[0057] Illustratively, the shock wave electrode device 11 in this embodiment has four electrode gaps 15 evenly arranged in the circumferential direction on the cross section of the same catheter 31. Considering its generality, in order for the shock wave electrode device 11 to maintain the balance of the force received during discharge, the multiple electrode gaps 15 in the cross section of the same catheter 31 should be arranged at equal intervals in the circumferential direction of the catheter 31. That is, for a shock wave catheter system made using the shock wave electrode device 11 of different specifications described in the second embodiment, when the number of electrode pairs in the same cross section is two pairs, the two electrode gaps 15 are distributed at intervals of 180° in the circumferential direction of the catheter 31. When the number of electrode gaps 15 in the same cross section is three, the electrode gaps 15 are distributed at intervals of 120° in the circumferential direction of the catheter 31, and the following analogy is made. The above-mentioned interval arrangement method allows the catheter 31 to maintain the balance of the force received during discharge of the electrode pairs.

[0058] Exemplarily, the independent channel 62 extends through the hollow portion of the balloon 61 from the distal end of the catheter 31 along the axial direction to the proximal end of the catheter 31, and communicates with a catheter joint 64. A liquid medium can be injected into the independent cavity 63 consisting of the balloon 61 and the catheter 31 through an injection cavity in the catheter joint 64. The liquid medium includes water, saline, contrast medium, or a mixture of the above liquids. An extension lead 65 connects the shock wave electrode device 11 to an external energy generator 67 through the catheter joint 64.

[0059] For example, a developing ring 54 is attached to the catheter 31. The developing ring 54 is attached so as to surround the catheter 31 and is located within the balloon 61. The developing rings 54 after the sleeve are located above both ends of the flexible printed wiring board 12 and play a role in reinforcing and protecting the flexible printed wiring board 12. When the shock wave catheter system is fed to the lesion site along the guide wire, the position of the shock wave electrode device 11 can be confirmed by the developing rings 54.

[0060] Optionally, the shockwave catheter system further includes an auxiliary support structure for mounting the shockwave electrode device 11. The auxiliary support structure is installed in the independent cavity 63. The shockwave electrode device 11 is mounted on the auxiliary support structure. The auxiliary support structure is typically any one or combination of a support tube, a stent, a balloon, and a probe.

[0061] Optionally, the support structure may be expanded, released or moved within the capsule structure to provide the ability to adjust the position of the electrode assembly 13 .

[0062] Optionally, the shock wave electrode device further comprises a micro-element. The micro-element may be integrated in the flexible printed wiring board by a printed circuit method, or integrated on the surface of the flexible printed wiring board 12 by a chip-on-film package method. The number of the micro-elements may be any natural number, such as 0, 1, 2, or 3. The micro-elements may be one or more of sensors (e.g., temperature sensors, potential sensors, pressure sensors, impedance sensors, etc.), therapeutic elements (e.g., thermocouples, ablation devices, etc.), and imaging elements (e.g., intravascular ultrasound imaging transducers, etc.).

[0063] The shock wave electrode device 11 according to this embodiment is similar to the shock wave electrode device described in the typical specification of the second embodiment. As shown in Fig. 6 and Fig. 7, the flexible printed wiring board 12 of this shock wave electrode device 11 is composed of one single-layer flexible substrate 21 and two conductive pattern layers 22 located on the upper and lower surfaces of the flexible substrate 21. The electrode assembly 13 and a part of the printed conductor 14 are integrated in the conductive pattern layer 22 on the upper surface of the flexible substrate 21, and the conductive pattern layer 22 on the lower surface of the flexible substrate 21 is the printed conductor 14 for realizing the conduction of the circuit. The electrode assembly 13 and the printed conductor 14 are printed on the surface of the flexible substrate 21 by a process such as etching, deposition, and compression bonding. The covering layer 16 is covered on the surface of the flexible substrate 21 on which the electrode assembly 13 and the printed conductor 14 are integrated, and an opening 17 is formed in the electrode gap 15, exposing the electrode gap 15 and a part of the electrode assembly 13 to the surface of the flexible printed wiring board 12. The shock wave electrode device 11 is fixed to the catheter 31 by adhesive, and the upper surface of the flexible printed wiring board 12 should be exposed to the inner space of the independent cavity 63. At this time, the electrode gap 15 can contact the medium of the independent cavity 63. Figure 10 shows a cross-sectional view of the above shock wave catheter system corresponding to the electrode assembly 13.

[0064] Illustratively, the shockwave catheter system includes an extension lead 65. The start end of the extension lead 65 is connected to the end of the printed conductor 14 of the shockwave electrode device 11 and extends to the outside of the catheter 31 through the energy transmission path of the catheter joint 64, and the other end of the extension lead 65 is joined to the high-voltage electrical plug 66 and then connected to an external energy generator or control handle 67. In some embodiments, a longer flexible printed wiring board 12 can be extended directly to the high-voltage electrical plug 66 through the catheter joint 64, directly connected to each channel plug 71 in the high-voltage electrical plug 66, and finally connected to the external energy generator or control handle 67. A partial schematic diagram of this connection method is shown in FIG.

[0065] Generally, each electrode gap 15 is individually connected to the energy generator 67 to realize individual control of each shock wave generation point, so that different voltages / currents are applied to different severity of lesions. Multiple electrode gaps 15 can be connected in series / parallel / mixed arrangements and then further connected to the energy generator 67 to jointly generate shock waves to achieve a wider range of treatment effects.

[0066] The above-mentioned embodiment is merely illustrative of the principle and effect of the present invention, and is not intended to limit the present invention. Any equivalent structure or equivalent flow conversion made by using the contents of the specification and drawings of the present invention, or anything directly or indirectly applied in other related technical fields, is included in the scope of the claims of the present invention. [Industrial Applicability]

[0067] The shock wave electrode device of the present invention uses the flexible printed circuit board to replace the complex wires, electrodes and other components and arrangement of the traditional shock wave generator in the blood vessel, realizing the miniaturization and integration of the liquid electrostatic generating electrodes, reducing the difficulty of manufacturing the liquid electrostatic electrodes, increasing the density of the liquid electrostatic electrodes, and improving the uniformity of the discharge energy. The shock wave electrode device using this type of liquid electrostatic electrodes has the advantages of accurately controlling the gap between each electrode, accurately positioning each electrode, high discharge stability, and balanced and controllable shock wave energy. At the same time, the electrodes, wires, electrodes and microelements and other components are integrated on the flexible printed circuit board, avoiding the problems of inaccurate positioning, insufficient insulation, and weak connection, and also significantly reducing the connection work between each component, simplifying the production process of the shock wave discharge electrode device, and having the advantages of easy installation. The shock wave catheter system manufactured using the shock wave electrode device provided by the present invention has the advantages of miniaturization and integration, while improving the shock wave performance and stability of the catheter. Furthermore, the catheter production manufacturing process can be simplified, productivity can be increased, and production costs can be reduced.

Claims

1. A shock wave electrode device comprising: A flexible printed wiring board and an electrode assembly are provided. The flexible printed wiring board includes a flexible substrate made of a single or multiple laminated insulating materials, a conductive pattern layer made of printed conductors located on a surface of the flexible substrate, and / or a covering layer made of an insulating material and covering the surface of the flexible printed wiring board; the electrode assembly is integrated on the conductive pattern layer inside the flexible printed wiring board or on a surface of the flexible printed wiring board, and includes at least a pair of positive and negative electrodes; Each pair of positive and negative electrodes has an electrode gap between the positive and negative electrodes, A shock wave electrode device characterized in that the flexible substrate and / or the covering layer have through openings formed in all of the electrode gaps in the flexible printed wiring board, exposing the electrode assembly and some or all of the electrode gaps on the surface of the flexible printed wiring board.

2. 2. The shock wave electrode device according to claim 1, wherein the flexible printed wiring board is a single-layer board, a double-sided board, a multi-layer board, or a soft board portion of a soft-hard combined board.

3. The flexible substrate, the conductive pattern layer and the covering layer are connected to each other by a compression bonding process; 2. The shock wave electrode device according to claim 1, wherein the flexible substrate, the conductive pattern layer and the covering layer are fixed to each other with an adhesive.

4. 2. The shock wave electrode device according to claim 1, wherein an electromagnetic shielding film is applied to the surface of the covering layer, and a back rubber is pre-applied to the bottom surface of the flexible printed wiring board.

5. The shock wave electrode device according to any one of claims 1 to 4, characterized in that the insulating material of the flexible substrate and / or the covering layer includes at least one or more of polyimide, polyethylene terephthalate, polyether ether ketone, aramid fiber ester, polyvinyl chloride and polytetrafluoroethylene.

6. The electrode assembly is printed and integrated on the conductive pattern layer of the flexible printed wiring board by one or more combinations of etching, deposition, rolling or electrolytic processes, or a conductive member is integrated on the surface of the flexible printed wiring board through one or more combinations of patch, welding or crimping processes; 2. The shock wave electrode device according to claim 1, wherein the pairs of positive and negative electrodes are connected in series, parallel or mixed arrangement via the printed conductors.

7. The shock wave electrode device further includes a reinforcement device, The reinforcing device is a pre-integrated structure of the flexible printed wiring board or an independent structure integrated into the flexible printed wiring board; The reinforcing device is located on the surface or between the inner pressure-bonding layers of the flexible printed wiring board, and the material of the reinforcing device includes at least one or more of the following: Organic polymeric materials, and / or Inorganic non-metallic materials, and / or 5. The shock wave electrode device according to claim 1, further comprising a metal.

8. 1. A shock wave catheter system comprising: a catheter including a proximal catheter section and a distal catheter section extending axially to a distal end; An independent chamber; A shock wave electrode device according to any one of claims 1 to 7, a catheter joint; the catheter includes at least one independent channel extending from the proximal catheter section to the distal catheter section; the independent chamber is formed by an expandable capsule structure located in an outer space of the distal catheter portion and at least one of the independent channels; a proximal side of the independent channel extends axially from the proximal catheter section and is connected to the capsule structure, an interior space of the independent channel combining with a hollow portion of the capsule structure to form an independent expandable chamber; The independent chamber is used to fill and store a liquid medium and isolate it from human tissue and blood, and the independent chamber is capable of withstanding a relative pressure of at least one standard atmospheric pressure of the liquid medium to prevent leakage of the liquid medium or rupture of the independent chamber; the shockwave electrode device is located within the independent chamber, the electrode assembly is located within the independent chamber near the distal catheter section, and the flexible printed wiring board of the shockwave electrode device extends through the independent channel to the proximal catheter section of the catheter; the catheter fitting is connected to the proximal catheter section, and at least one channel of the catheter fitting is connected to the independent chamber for transferring the liquid medium; A shockwave catheter system, characterized in that the printed conductor of the shockwave electrode device forms an energy transmission path through at least one channel of the catheter joint.

9. The single or multiple positive and negative electrodes of the electrode assembly are arranged along the circumferential and / or axial direction of the catheter inside the independent chamber to form one or multiple electrode gaps distributed in the circumferential and / or axial directions; 9. The shockwave catheter system according to claim 8, wherein the arrangement shape of the electrode gaps inside the independent chamber includes one or more of the following: polygonal, annular, arcuate, and surround.

10. the material of the catheter and capsule structure is one or a mixture of thermoplastic polymer compounds, silica gel, rubber and polymer fiber compounds; 9. The shockwave catheter system according to claim 8, wherein the liquid medium is a mixture of at least one of physiological saline, a contrast agent, and / or water for injection.

11. The catheter further includes an extension lead; The start end of the extension lead is connected to the printed conductor of the shockwave electrode device; the extension lead extends through the energy transmission passage of the catheter joint to the exterior of the catheter; The shockwave catheter system according to any one of claims 8 to 10, characterized in that the distal end of the extension lead is connected to an external energy generator or a control handle.

12. the catheter further includes a high voltage electrical plug connected to the energy transmission passage of the catheter joint; The shockwave catheter system of claim 11, wherein the flexible printed wiring board or the extension lead is connected to the external energy generator or the control handle via the high voltage electrical plug to realize energy transmission.

13. The shockwave catheter system further comprises a development ring; the development ring is fixed in the distal catheter portion or the capsule structure to serve as a development mark under X-ray of the working area of ​​the capsule structure; 13. The shock wave catheter system according to claim 12, wherein the development ring is provided to enclose an outer surface of the flexible printed wiring board and is used to fix the electrode assembly and the flexible printed wiring board.

14. A secondary support structure is further provided within the independent chamber; The shock wave electrode device is fixed inside the independent chamber by the auxiliary support structure; The auxiliary support structure may be any one or a combination of a support tube, a stent, a balloon, and a probe; The shockwave catheter system according to claim 13, wherein the auxiliary support structure is capable of adjusting the position of the electrode assembly by expanding, opening or moving within the capsule structure.

15. The shock wave catheter system further comprises a micro device integrated inside the flexible printed circuit board in the form of a printed circuit or integrated on the surface of the flexible printed circuit board in the form of a chip-on-film package; The microdevice comprises at least one or more of the following: Sensing element and / or Therapeutic elements and / or 15. The shock wave catheter system of claim 14, further comprising an imaging device.

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