CN215273265U - Electrode member and electrode balloon catheter - Google Patents

Abstract

The utility model provides an electrode part and electrode sacculus pipe, electrode part includes: a first electrode, a second electrode and a receiving structure; the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device. So set up for the electrode part arranges for the individual layer, has reduced the size that passes through of electrode sacculus pipe, makes the size that passes through of electrode sacculus pipe thinner, and the size that more is close to the sacculus of expanding in advance prevents that when electrode sacculus pipe from mediating, the phenomenon of taking place to be difficult to through even the subassembly rupture.

Description

Electrode member and electrode balloon catheter

Technical Field

The utility model relates to the technical field of medical equipment, in particular to electrode component and electrode sacculus pipe.

Background

Angioplasty is an operation method for restoring the original size of a stenotic vessel cavity by adopting a mechanical method, and the traditional angioplasty usually adopts a balloon catheter to physically dilate a stenotic lesion so as to ensure that a blood vessel is unblocked again. But is susceptible to adventitial tear damage upon balloon expansion. The method for indirectly crushing calcified sediments or 'stones' in the urinary tract or the biliary tract by utilizing the electrohydraulic effect can be used for destroying calcified focus structures attached to walls of diseased blood vessels, namely, the electrohydraulic calculus crushing technology can be applied to angioplasty. The principle of the liquid-electric stone breaking technology is that liquid is quickly vaporized under a high-voltage strong electric field to form steam bubbles and the steam bubbles expand outwards, and the bubbles are broken to generate strong shock waves and act on the surrounding environment of the liquid. Based on the principle that the structure of a calcification focus is destroyed by the liquid-electric effect, an electrode component is arranged in a balloon, the electrode component is connected with an external pulse power supply through an electric wire and the like laid in a catheter, when the balloon is placed near a calcification area of a blood vessel, high-voltage pulse is applied to the electrode component to form shock waves, and the shock waves are transmitted through conductive liquid in the balloon to impact the wall of the balloon and the calcification area. Repeated pulse can destroy the structure of a calcified focus, expand a narrow blood vessel without damaging surrounding soft tissues, and can avoid the problem of blood vessel wall injury caused by balloon expansion in the traditional angioplasty.

At present, because the electrodes of the electrode balloon catheter are arranged in a multilayer manner, the outer diameter of the catheter is increased, and the trafficability characteristic is poor. When the electrode balloon catheter is inserted into a human body, the electrode balloon catheter is difficult to pass through a narrow blood vessel region, and the hypotube at the joint of the near end and the far end can be broken if the electrode balloon catheter is inserted for multiple times.

Therefore, it is an urgent need to develop an electrode member provided in an electrode balloon catheter to make the passing size of the electrode balloon catheter smaller and the passing size closer to the size of a pre-expanded balloon, thereby preventing the electrode balloon catheter from being difficult to pass through or even breaking the components when the electrode balloon catheter is inserted.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an electrode part and electrode sacculus pipe for the size of the sacculus is expanded in advance to the size of passing through that the size is thinner, through the size is closer of electrode sacculus pipe, takes place to be difficult to through the problem of subassembly rupture even when solving electrode sacculus pipe and intervene.

In order to solve the above technical problem, the utility model provides an electrode component for electrode sacculus pipe, include: a first electrode, a second electrode and a receiving structure; the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device.

Optionally, the shape of at least part of the second electrode matches the shape of the receiving structure.

Optionally, the first electrode is of an annular structure and is arranged around the circumference of the electrode balloon catheter, and the second electrode is of a sheet shape.

Optionally, at least two receiving structures are disposed on each first electrode, and each receiving structure is disposed in a manner of being matched with one second electrode.

Optionally, the first electrode and/or the second electrode are disposed on the electrode balloon catheter in a manner of pasting, printing, electroplating, 3D printing, or vapor deposition.

Optionally, the electrode assembly further includes an insulating connector, and the insulating connector is respectively connected to the first electrode and the second electrode, and is configured to fix a relative position of the first electrode and the second electrode.

Optionally, the second electrode is fixedly connected to the insulating connecting member, the insulating connecting member is clamped to the first electrode, and the insulating connecting member, the first electrode, and the second electrode are all arranged on the electrode balloon catheter on the same layer.

Optionally, the insulating connecting member is laid on the accommodating structure, and the second electrode is disposed on the insulating connecting member.

Optionally, the receiving structure is disposed through the first electrode, or the receiving structure is disposed on a surface of the first electrode.

Optionally, the surface of the first electrode and/or the second electrode has micron-sized tips, and the tips are in a group peak shape.

In order to solve the above technical problem, the utility model provides an electrode assembly for electrode sacculus pipe, include: a first electrode and a plurality of second electrodes; the first electrode is provided with a plurality of accommodating spaces which are used for being respectively embedded into at least part of each second electrode in the plurality of second electrodes, the first electrode and the second electrodes are arranged at intervals, and the area of the first electrode is larger than that of the second electrodes; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device.

Optionally, the first electrode is of an annular structure and sleeved on the electrode balloon catheter, the second electrode is of a circular sheet shape, and the plurality of second electrodes are uniformly arranged along the circumferential direction of the first electrode.

Optionally, the first electrode and the second electrode are fixed in position by an insulating connector.

Optionally, the insulating connecting member is laid in the accommodating space, and the second electrode is disposed on the insulating connecting member.

In order to solve the above technical problem, the present embodiment further provides an electrode balloon catheter, including: a balloon, an inner catheter, and an electrode component as described above; the balloon is sleeved outside the inner catheter and expands or contracts along the radial direction under the filling and extraction of filling liquid; the electrode component is arranged on the inner catheter, is positioned in the balloon and is used for being connected with a high-voltage generation processing device.

Optionally, the electrode balloon catheter further comprises a flexible circuit layer disposed on the inner catheter; the flexible circuit layer is respectively connected with the first electrode and the second electrode, and the first electrode and the second electrode are connected with the high-voltage generation processing device through the flexible circuit layer.

In the utility model provides a pair of electrode part and electrode sacculus pipe, electrode part includes: a first electrode, a second electrode and a receiving structure; the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device. So set up for the electrode part arranges for the individual layer, has reduced the size that passes through of electrode sacculus pipe, makes the size that passes through of electrode sacculus pipe thinner, and the size that more is close to the sacculus of expanding in advance prevents that when electrode sacculus pipe from mediating, the phenomenon of taking place to be difficult to through even the subassembly rupture.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. Wherein:

fig. 1 is a schematic view of an electrode balloon catheter according to a first embodiment of the present invention.

Fig. 2 is a schematic view of an inner catheter according to a first embodiment of the present invention.

Fig. 3 is a circuit diagram of a high voltage generation processing device according to a first embodiment of the present invention.

Fig. 4 is a simplified equivalent circuit diagram of a high voltage generating unit according to a first embodiment of the present invention.

Fig. 5 is a flowchart of an electrode balloon catheter and a high-pressure generation processing device according to a first embodiment of the present invention.

Fig. 6 is a flow chart illustrating the safe operation of the electrode balloon catheter and the high-pressure generating and processing device according to the first embodiment of the present invention.

Fig. 7a is a schematic view of an electrode assembly according to a first embodiment and a third embodiment of the present invention.

Fig. 7b is another schematic view of the electrode assembly according to the first and third embodiments of the present invention.

Fig. 8a is a schematic view of an electrode assembly according to a second embodiment and a third embodiment of the present invention.

Fig. 8b is another schematic view of the electrode assembly according to the second and third embodiments of the present invention.

Fig. 9 is a schematic view of a tip of a first electrode of an electrode assembly according to a first embodiment of the present invention.

In the drawings:

100-balloon, 110-filling fluid;

200-an inner conduit;

300-shock wave generating component, 310-flexible circuit layer, 311-positive wire, 312-negative wire, 320-electrode component, 3201-first electrode, 3202-second electrode, 3203-containing structure, 3204-insulating connecting piece, 3205-tip, a-first connecting port, B-second connecting port, C-third connecting port, D-fourth connecting port, E-electrode wire, 321-positive electrode, 322-negative electrode, 340-conduit connecting piece, 341-external positive wire, 342-external negative wire;

400-an outer catheter;

500-high voltage generation processing device, 510-logic processing unit, 511-logic processor, 520-high voltage generation unit, 521-high voltage generator, 522-high voltage resistor, 523-high voltage capacitor, 530-amplifying circuit, 540-display unit, 541-display, 550-trigger unit, 550 a-trigger device, 551-first switch, 552-second switch, 560-sampling circuit, 570-connector, 580-operating handle;

600-a temperature sensor;

700-hydraulic pressure sensor;

800-pressure sensor.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be noted that the drawings are in simplified form and are not to scale, but rather are provided for the purpose of facilitating and distinctly claiming the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.

As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. In addition, in the following description, for convenience of description, "distal" and "proximal" are used, the "proximal" referring to an end close to the operator of a patient, and the "proximal" referring to an end close to the operator of a patient. Furthermore, in the following description, numerous specific details are set forth in order to provide a more thorough understanding of the present invention. It will be apparent, however, to one skilled in the art, that the present invention may be practiced without one or more of these specific details. In other instances, well-known features have not been described in order to avoid obscuring the present invention.

The embodiment of the utility model provides an electrode part and electrode sacculus pipe, electrode part includes: a first electrode, a second electrode and a receiving structure; the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device. The embodiment of the utility model provides a still provide an electrode part, electrode part includes: a first electrode and a plurality of second electrodes; the first electrode is provided with a plurality of accommodating spaces, the accommodating spaces are used for being respectively embedded into at least part of each second electrode in the plurality of second electrodes, the first electrode and the second electrodes are arranged at intervals, and the area of the first electrode is larger than that of the second electrodes; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device. So set up for the electrode part arranges for the individual layer, has reduced the size that passes through of electrode sacculus pipe, makes the size that passes through of electrode sacculus pipe thinner, and the size that more is close to the sacculus of expanding in advance prevents that when electrode sacculus pipe from mediating, the phenomenon of taking place to be difficult to through even the subassembly rupture.

The following description refers to the accompanying drawings.

[ EXAMPLES one ]

Referring to fig. 1 to 7b, fig. 1 is a schematic view of an electrode balloon catheter according to a first embodiment of the present invention; fig. 2 is a schematic view of an inner catheter according to a first embodiment of the present invention; fig. 3 is a circuit diagram of a high voltage generation processing apparatus according to a first embodiment of the present invention; fig. 4 is a simplified equivalent circuit diagram of a high voltage generating unit according to a first embodiment of the present invention; fig. 5 is a flowchart of an electrode balloon catheter and a high-pressure generation processing device according to a first embodiment of the present invention; fig. 6 is a flow chart of safe operation of the electrode balloon catheter and the high-voltage generation processing device according to the first embodiment of the present invention; fig. 7a is a schematic view of an electrode assembly according to a first and a third embodiment of the present invention; fig. 7b is another schematic view of the electrode assembly according to the first and third embodiments of the present invention. Fig. 9 is a schematic view of a tip of a first electrode of an electrode assembly according to a first embodiment of the present invention.

The electrode member 320 provided in this embodiment can be used in an electrode balloon catheter, which is described first herein. As shown in fig. 1, the electrode balloon catheter includes a balloon 100, an inner catheter 200, and a shock wave generating assembly 300. The electrode balloon catheter 100 preferably further comprises an outer catheter 400, the outer catheter 400 is sleeved outside the inner catheter 200, and the outer catheter 400 is connected with the balloon 100.

The balloon 100 is, for example, a fusiform balloon, and the balloon 100 is sleeved outside the inner catheter 200, for example, may be sleeved at the distal end of the inner catheter 200. Of course, the balloon 100 may also be a cylindrical structure, and may also be sleeved at a position between the proximal end and the distal end of the inner catheter 200. The inner conduit 200 is, for example, a cylinder. The balloon 100 is preferably disposed along the axial extension of the inner catheter 200. Preferably, the distal end of the balloon 100 is connected to the distal end of the inner catheter 200, and the proximal end of the balloon 100 is connected to the distal end of the outer catheter 400. The balloon 100 expands or contracts in the radial direction of the balloon 100 under the filling and extraction of the filling liquid 110. The inflation fluid 110 may be a conductive fluid that may be inflated inside the balloon 100 such that the balloon 100 may expand or contract. The filling volume of filling fluid 110 is preferably the natural lumen volume of balloon 100 in the undeformed state. The filling fluid 110 may be saline, contrast fluid, or a mixture of saline and contrast fluid. In other embodiments, the filling liquid 110 may be a non-conductive liquid, or may be other filling liquids that can be used in a human body.

The shock wave generating assembly 300 includes an electrode member 320. Preferably, the shock wave generating assembly 300 further comprises a flexible circuit layer 310.

As shown in connection with fig. 2, the flexible circuit layer 310 is disposed on the inner catheter 200. The flexible circuit layer 310 preferably has a certain flexibility and a thinner thickness. The flexible circuit layer 310 is, for example, a flexible circuit patch, and can be attached to the outer surface of the inner catheter 200, so that the radial dimension of the electrode balloon catheter can be the sum of the diameter of the inner catheter 200 and the radial dimension of the flexible circuit layer 310, and then the electrode balloon catheter and the current balloon catheter bind a plurality of positive and negative wires together, and then compared with the arrangement mode of combining the inner catheter thereof, the passing dimension of the electrode balloon catheter can be smaller and is closer to the diameter of the pre-expanded balloon, thereby improving the passability of the electrode balloon catheter for being inserted into a human body, avoiding the components in the electrode balloon catheter from being broken, and enabling the electrode balloon catheter to reach a lesion through a narrower region in a blood vessel. Understandably, the pass size of the electrode balloon catheter may represent the radial dimension through the vessel; the diameter of the pre-expanded balloon represents the diameter size of the balloon 100 when it is not inflated. The flexible circuit layer 310 preferably includes a positive electrode line 311 and a negative electrode line 312, and more preferably, the flexible circuit layer 310 further includes an insulating protective film, the positive electrode line 311 and the negative electrode line 312 are disposed on the insulating protective film, and the insulating protective film is attached to the inner conduit 200. The positive electrode line 311 or the negative electrode line 312 is made of, for example, a conductive copper foil, but the material of the positive electrode line and the negative electrode line may be made of other materials having high conductivity, such as a metal material, e.g., gold, silver, or platinum. Of course, the flexible circuit layer 310 may also be disposed on the inner surface of the inner catheter 200 or in the middle layer, so as to prevent the flexible circuit layer 310 from contacting the filling liquid 110 on the outer surface of the inner catheter 200, thereby reducing the potential safety hazard. It will be appreciated that the radial dimension of the flexible circuit layer 310 is as small as possible, as the circuitry allows, so that the pass size of the electrode balloon catheter is minimized, thereby allowing the pass size to be closer to the diameter of the pre-expanded balloon. The proximal end of the flexible circuit layer 310 is connected to a high voltage generating and processing device 500, and the distal ends of the flexible circuit layer 310 are connected to the electrode members 320, respectively. The high voltage generating and processing device 500 includes, for example, a high voltage generating unit 520, and the high voltage generating unit 520 is capable of generating a high voltage pulse, so that the flexible circuit layer 310 can transmit the high voltage pulse, and the electrode member 320 receives the high voltage pulse to generate a shock wave.

With continued reference to fig. 1 and 2, the electrode member 320 is disposed on the inner catheter 200 and inside the balloon 100, so that the electrode member 320 can contact the filling liquid 110 inside the balloon 100. The electrode member 320 is connected to the flexible circuit layer 310 for connection to a high voltage generating and processing device 500 through the flexible circuit layer 310. Specifically, the electrode member 320 includes a positive electrode 321 and a negative electrode 322, the positive electrode 321 is connected to the positive line 311, and the negative electrode 322 is connected to the negative line 312. The shock wave generating assembly 300 has the following shock wave generating principle that the electrode balloon catheter is inserted into a narrow blood vessel part with a calcified focus structure, the electrode part 320 breaks through the filling liquid 110 at the discharge gap through positive and negative electrode discharge or arc discharge, the filling liquid 110 generates a large amount of bubbles, the shock wave is released by the expansion and disappearance stress of the bubbles, the shock wave is transmitted to the focus part, the calcified focus is softened and ruptured, the calcified focus structure of the target blood vessel is destroyed, and the purpose of smoothing the blood vessel is achieved. The method is used for treating patients, makes up the defects of the traditional balloon dilatation, improves the success rate of the operation and reduces the postoperative complications.

Preferably, on the premise that the flexible circuit layer 310 can ensure the passage of high voltage and high current, the radial thickness of the flexible circuit layer 310 along the inner catheter 200 is not more than 0.2mm, so that the passage size of the electrode balloon catheter is close to the size of the pre-expanded balloon. In addition, the flex circuit layer 310 is excellent in bending performance. Still further, the radial thickness of the flex circuit layer 310 may be less than 0.1mm, further reducing the pass through size. Of course, one skilled in the art can also set the size of the flexible circuit layer 310 along the radial thickness of the inner catheter 200 according to actual needs.

Further, in order to enable the flexible circuit layer 310 to be better connected with the inner catheter 200, the flexible circuit layer 310 is preferably disposed on the inner catheter 200 in a manner of pasting, printing, electroplating, 3D printing or vapor deposition, so that the overall outer diameter of the electrode balloon catheter is reduced, and the passing performance is improved. Specifically, the Flexible Circuit layer 310 may be provided with a positive line and a negative line in a Flexible Printed Circuit (FPC) manner, and the Flexible Circuit layer 310 is attached to the inner guide tube 200. The flexible circuit layer 310 may also be printed with a positive line and a negative line directly on the inner catheter 200 by means of a printed circuit. The flexible circuit layer 310 may also be disposed using electroplating, 3D printing, or vapor deposition. Of course, the flexible circuit layer 310 may also adopt a combination of these several manners, for example, the positive line 311 of the flexible circuit layer 310 adopts a 3D printing manner, and the negative line 312 is disposed by vapor deposition, or the positive line 311 adopts an electroplating manner, and the negative line 312 adopts a 3D printing manner. Therefore, the positive wire 311 and the negative wire 312 can be respectively attached to the outer surface of the inner conduit 200, so that the positive wire 311 or the negative wire 312 can be completely attached to the inner conduit 200, and the safety of the circuit is ensured. Preferably, the electrode wire of the flexible circuit layer 310 may be connected to the electrode member 320 by laser welding, soldering, or pressing. In the first embodiment, the negative electrode wire 312 and the negative electrode 322 are connected by laser welding, and the positive electrode wire 311 and the positive electrode 321 are connected by pressing. Of course, a person skilled in the art may also select the connection manner of the positive wire 311 and the negative wire 312 according to actual requirements, for example, the positive wire 311 is connected with the positive electrode 321 by laser welding, and the negative wire 312 is connected with the negative electrode 322 by pressing.

Further, as shown in fig. 2, the electrode balloon catheter further includes a temperature sensor 600, the temperature sensor 600 is disposed on the outer surface of the inner catheter 200 or the inner surface of the outer catheter 400, and the temperature sensor 600 is configured to measure the temperature inside the balloon 100 and send out the temperature signal, so that the electrode balloon catheter can monitor the temperature inside the balloon at any time when the shock wave is released, and risks in the operation are reduced. When filling liquid takes place the hydroelectric effect, filling liquid is because the increase of steam bubble, and then makes filling liquid's temperature increase, nevertheless filling liquid temperature is no longer than human normal temperature 2 ℃, consequently needs temperature sensor 600 to monitor filling liquid, prevents that filling liquid temperature is too high, influences treatment, influences human health even. When the electrode balloon catheter releases shock waves, the temperature state in the balloon can be monitored at any time, and risks in the operation are reduced. More preferably, the temperature sensor 600 includes a flexible temperature sensor, which can be attached to the outer surface of the inner catheter 200, thereby reducing the radial dimension of the electrode balloon catheter. The setting condition of the flexible temperature sensor can refer to the setting condition of the flexible circuit layer 310, and is not described herein again.

Preferably, as shown in fig. 1 and 2, the electrode balloon catheter further includes a hydraulic sensor 700, the hydraulic sensor 700 is disposed on the inner catheter 200, and the hydraulic sensor 700 is configured to monitor the hydraulic pressure inside the balloon in real time and send the filling pressure signal, so that the electrode balloon catheter can monitor the pressure state inside the balloon at any time when the shock wave is released, and risks in the operation are reduced. It should be understood that the gap between the inner catheter 200 and the outer catheter 400 is communicated with the inner cavity of the balloon 100, so that the hydraulic pressure sensor 700 can measure the filling hydraulic pressure inside the balloon when the hydraulic pressure sensor is disposed on the inner catheter 200 or the outer catheter 400. Preferably, the hydraulic pressure sensor 700 is disposed on the outer surface of the inner catheter 200 or the inner surface of the outer catheter 400, and thus the hydraulic pressure sensor 700 can better measure the pressure of the filling fluid. More preferably, the hydraulic sensor 700 may be disposed at a position near the proximal end of the inner catheter 200, thereby enabling the hydraulic sensor 700 to not increase the passing size of the electrode balloon catheter. Preferably, the hydraulic pressure sensor 700 includes a flexible hydraulic pressure sensor that can be attached to the outer surface of the inner catheter 200, thereby further reducing the radial dimension of the electrode balloon catheter.

Further, as shown in fig. 1 and 2, the electrode balloon catheter further includes a pressure sensor 800, the pressure sensor 800 is disposed at the distal end of the inner catheter 200, and is configured to monitor pressure, resistance, or pushing force applied to the electrode balloon catheter and send a resistance signal, so that the electrode balloon catheter can monitor the resistance or pushing force of the pressure sensor 800 at any time when the shock wave is released, thereby reducing risks in the operation. Preferably, the pressure sensor 800 is an annular pressure sensor, and the annular pressure sensor is sleeved at the distal end of the inner catheter 200, so that the pressure, the resistance or the pushing force can be detected more comprehensively.

Preferably, as shown in fig. 1, the electrode balloon catheter further includes a catheter connector 340, and the catheter connector 340 is used for connecting with an external high voltage generation processing device 500, and communicating a high voltage signal, a detection signal and the like with the high voltage generation processing device 500. It is understood that the size of the electrode balloon catheter may be set by one skilled in the art according to the requirements of the surgery or patient, such as the radial size of the balloon 100 after filling, the axial size of the balloon 100, the radial size of the inner catheter 200, and the like.

As shown in fig. 3, the first embodiment further provides a high voltage generation processing device 500, and the high voltage generation processing device 500 is used for signal connection with the electrode balloon catheter as described above. The high voltage generating and processing device 500 includes a logic processing unit 510 and a high voltage generating unit 520.

As shown in fig. 3, the logic processing unit 510 is electrically connected to the high voltage generating unit 520 and is used for controlling the connection and disconnection of the high voltage generating unit 520. For example, the logic processing unit 510 is, for example, a logic processor 511, the logic processor 511 has a logic circuit, and if the logic processing unit 510 receives a certain electrical signal, the logic processing unit 510 determines the disconnection and connection of the high voltage generating unit 520 according to the electrical signal. The logic processor 511 may employ an intentional semiconductor 32-bit serial microcontroller chip (STM32), a Field Programmable Gate Array (FPGA), or the like, instead of a microprocessor.

The logic processing unit 510 is in electrical signal connection with the hydraulic sensor 700 of the electrode balloon catheter and is used for receiving an inflation pressure signal sent by the hydraulic sensor 700; when the absolute value of the filling pressure difference or the falling rate of the filling pressure in the filling pressure signal received by the logic processing unit 510 exceeds a set threshold, the logic processing unit 510 cuts off the electrical signal connection with the high pressure generating unit 520. When the filling pressure value detected by the hydraulic sensor 700 suddenly drops, the dropping rate of the filling pressure or the absolute value of the difference of the filling pressures exceeds a set threshold value, which indicates that the balloon 100 is broken or other situations causing the sudden drop of the filling pressure value occur, and the logic processing unit 510 controls the high voltage generating unit 520 to cut off the voltage applied to the two electrodes, so that the safety of the operation is ensured. Preferably, the high voltage generation processing device 500 further includes an amplifying circuit 530, one end of the amplifying circuit 530 is connected to the logic processing unit 510, and the other end of the amplifying circuit 530 is connected to the hydraulic pressure sensor 700. The connection may be a communication connection, i.e., an electrical connection, etc., so that the signals of the hydraulic pressure sensor 700 can be transmitted to the logic processing unit 510.

Further, in practice, since the released shock wave can destroy the calcified structures at the vascular lesion, compress the calcified volume, and expand the lumen of the blood vessel, the filling pressure of the balloon 100 is reduced, and the outer diameter is correspondingly reduced, so that the balloon 100 does not completely fit the target blood vessel, the high pressure generating device 500 further includes a display unit 540, and the display unit 540 is, for example, a display 541. The display unit 540 is connected with the logic processing unit 510; when the filling pressure value deviates from the filling pressure range during the filling pressure operation, that is, when the filling pressure value of the filling pressure signal is greater than the set working pressure value, the hydraulic pressure sensor 700 is in signal connection with the logic processing unit 510, the logic processing unit 510 sends the filling pressure signal to the display unit 540, and the display unit 540 receives the filling pressure signal and sends a prompt signal. Preferably, the display unit 540 has a sound and light generator, and the prompt signal can be a sound and light prompt, and of course, those skilled in the art can set other prompt signals according to actual needs.

Preferably, the logic processing unit 510 is further configured to receive a resistance signal sent by a pressure sensor 800 of the electrode balloon catheter, the pressure sensor 800 can provide protection for intervention of the electrode balloon catheter, when a resistance value of the resistance signal is greater than a set threshold, the logic processing unit 510 sends the resistance signal to the display unit 540, and the display unit 540 receives the resistance signal and sends an alarm signal. Similarly, the alarm signal may be an audible and visual alarm of the sound and light generator of the display unit 540, or may be in other forms. It is to be understood that the resistive force may also be understood as the push force of the pressure sensor 800 due to the interaction of forces. Preferably, one end of the amplifying circuit 530 is connected to the logic processing unit 510, and the other end of the amplifying circuit 530 is connected to the pressure sensor 800, so that the signal of the pressure sensor 800 can be transmitted to the logic processing unit 510.

More preferably, the logic processing unit 510 is further configured to receive a temperature signal sent by the temperature sensor 600 of the electrode balloon catheter, and when a temperature value of the temperature signal is greater than a set threshold, the logic processing unit 510 switches off the high voltage generating unit 520. The logic processing unit 510 controls the high voltage generating unit 520 to cut off the voltage applied to the two poles, thereby ensuring the safety of the operation. Preferably, one end of the amplifying circuit 530 is connected to the logic processing unit 510, and the other end of the amplifying circuit 530 is connected to the temperature sensor 600, so that the signal of the temperature sensor 600 can be transmitted to the logic processing unit 510.

In summary, the temperature sensor 600, the hydraulic pressure sensor 700 and the pressure sensor 800 of the present embodiment can monitor the temperature, the pressure and the pushing force inside the balloon, and the high pressure generating and processing device 500 responds accordingly according to the feedback signal thereof, so as to improve the efficiency of breaking calcified lesions, reduce the risk and reduce the injury to the patient.

Preferably, to avoid causing a brief ventricular capture or shock during the delivery of the shock wave, the high voltage generating processing device 500 will monitor the frequency of delivery and the time to fill the balloon 100 in real time. Therefore, the high voltage generation processing device 500 further comprises a timer (not shown), which is connected to the logic processing unit 510; when the filling pressure of the filling pressure signal received by the logic processing unit 510 reaches the set filling pressure, it should be understood that when the filling pressure reaches the set filling pressure, it indicates that the shock wave starts to be released. At this time, the timer starts to count time, the count time of the timer reaches a set time, for example, the set time is 10 seconds, the timer sends a time signal to the logic processing unit 510, the logic processing unit 510 receives the time signal and sends the time signal to the display unit 540, the display unit 540 receives the time signal and sends a prompt signal to prompt an operator to withdraw the filling liquid 110 in the balloon 100, and after waiting for a certain time, the operator refills the balloon 100 with the filling liquid 110 again to release a shock wave. The timer is arranged, so that the high-voltage generation processing device 500 can control the time for releasing the shock wave, and the risk existing in the operation is further reduced.

It should be understood that, referring to fig. 4, the high voltage generating unit 520 includes a high voltage generator 521, a high voltage capacitor 523 and a triggering unit 550, and the triggering unit 550 is connected to the logic processing unit 510. The trigger unit 550 is, for example, a trigger device 550a, and the trigger device 550a includes, for example, a high voltage relay, an Insulated Gate Bipolar Transistor (IGBT), etc., but other forms are also possible to those skilled in the art. The trigger unit 550 includes a first switch 551 and a second switch 552, the first switch 551 is disposed between the high voltage generator 521 and the high voltage capacitor 523, and the second switch 552 is disposed between the high voltage capacitor 523 and the electrode member 320. The logic processing unit 510 controls the switching of the first switch 551 and the second switch 552. When the high voltage generator 521 charges the high voltage capacitor 523, the first switch 551 of the trigger unit 550 is in a closed state, and the second switch 552 is in an open state; when the electrode balloon catheter reaches the treatment position, the logic processing unit 510 controls the trigger unit 550 to change the states of the first switch 551 and the second switch 552, so that the first switch 551 is opened, the second switch 552 is closed, and the high-voltage capacitor 523 applies voltage to the positive electrode 321 and the negative electrode 322 of the electrode part 320 to form relatively large current, so that an electric arc is generated between the positive electrode 321 and the negative electrode 322 soaked in the filling liquid 110, and the electric arc generates a shock wave in the filling liquid 110.

Further, in order to ensure the safety of the operation, as shown in fig. 3, the high voltage generation processing device 500 further includes a sampling circuit 560, and the sampling circuit 560 is used for detecting whether the voltage of the high voltage generation unit 520, the electrode member 320 of the electrode balloon catheter or the flexible circuit layer 310 are short-circuited. Taking the detection of the high voltage generating unit 520 as an example, before an operation, an operator performs voltage detection on the electrode balloon catheter, the logic processing unit 510 sends a signal to the high voltage generator 521, the high voltage generator 521 generates high voltage to charge the high voltage capacitor 523 through a high voltage resistor 522, meanwhile, the sampling circuit 560 collects the voltage, feeds the voltage back to the logic processing unit 510, and displays the voltage on a display, taking the detection of the electrode part 320 or the flexible circuit layer 310 as an example, the high voltage generator 521 generates an electric signal, the sampling circuit 560 collects the electric signal of the electrode part 320 or the flexible circuit layer 310, and after the short-circuit-free prompt is determined, the operator can intervene in the operation according to the conventional minimally invasive method.

Preferably, as shown in fig. 1 and 3, the high voltage generation processing device 500 further includes a connector 570 and an operating handle 580. The connector 570 is used as a connection port of the high voltage generation processing device 500 to the outside, and is used for being connected with the electrode balloon catheter. The connector 570 is connected to the catheter connector 340 of the electrode balloon catheter, so that the high voltage signal and the detection signal of the high voltage generation processing device 500 can be communicated with the electrode balloon catheter. Further, the connector 570 is electrically connected to the electrode balloon catheter. The conduit connector 340 comprises an external positive wire 341 and an external negative wire 342, the external positive wire 341 is connected with the positive wire 311, and the external negative wire 342 is connected with the negative wire 312. The operation handle 580 is used for controlling the on and off of the logic processing unit 510.

The operation of the electrode balloon catheter and the high voltage generating and processing device 500 and the circuit connection of the high voltage generating and processing device 500 will be described with reference to fig. 1 to 6.

First, please refer to fig. 3, wherein the operator adjusts the mode of the logic processing unit 510 of the high voltage generating and processing device 500 according to the condition of the patient, for example, the patient is a coronary artery, a peripheral artery, or a valve, so as to select the voltage value required when the electrode member 320 releases the shock wave, the filling pressure value range when the balloon 100 is expanded, the resistance value range received by the pressure sensor 800, and the like in different modes. After the mode is selected, i.e. after the interface selection is determined, the connector 570 is connected with the electrode balloon catheter with the size corresponding to the condition. Thereafter, the operator performs preoperative examination. The high voltage generator 521 generates high voltage to charge the high voltage capacitor 523 through the high voltage resistor 522, and simultaneously, performs information such as voltage and short circuit detection through the sampling circuit 560, feeds the information back to the logic processing unit 510 and displays the information on the display 541, and performs interventional operation after determining that the voltage value meets the set requirement and no short circuit prompt exists.

The operator then delivers the electrode balloon catheter to the vascular lesion. In the process of delivering the electrode balloon catheter, the pressure sensor 800 feeds back the pushing force to the logic processing unit 510 through the amplifying circuit 530, and when the pushing force value is greater than the threshold value, the display 541 gives an audible and visual alarm. When reaching a vascular lesion, the filling fluid 110 fills the balloon 100, and the hydraulic sensor 700 monitors the filling pressure inside the balloon 100 in real time. When the shock wave is released, the hydraulic pressure sensor 700 and the temperature sensor 600 communicate with the logic processing unit 510 in real time through the amplifying circuit 530, so as to perform pressure detection and temperature detection. If the internal temperature received by the temperature sensor 600 is higher than the alarm threshold, the logic processing unit 510 controls the high voltage generator 521 to cut off the voltage applied to the two electrodes; if the filling pressure value received by the hydraulic pressure sensor 700 drops suddenly, the logic processing unit 510 controls the high voltage generator 521 to cut off the voltage applied to the two electrodes; if the filling pressure of the balloon 100 deviates beyond the preset working filling pressure range, the display 541 sends out a prompt signal. During the process of releasing the shock wave, the time for releasing the shock wave exceeds 10 seconds, the logic processing unit 510 communicates with the display 541 to prompt the operator to withdraw the filling liquid 110 in the balloon 100, and after waiting for a certain time, the operator refills the balloon 100 with the filling liquid 310 again to release the shock wave.

Further, please refer to fig. 5, in order to more clearly show the working process of the electrode balloon catheter and the high voltage generation processing device 500, the first embodiment provides the working steps of the electrode balloon catheter and the high voltage generation processing device 500.

S1: and starting.

S2: and (5) initializing the test. The high voltage generation processing device 500 detects whether all parameters of the electrode balloon catheter and the high voltage generation processing device 500 are normal, such as whether short circuit occurs or not, whether voltage is lost or not. If all the parameters meet the standard, carrying out the next step; if one of all the parameters does not meet the standard, the initialization detection is unqualified.

S3: and activating the high-voltage power supply to charge the capacitor.

S4: and judging whether the voltage reaches a set value. In particular, the capacitor voltage may be detected. When the capacitance voltage reaches a threshold value, the next step condition is achieved, namely the electrode balloon catheter is inserted into a human body; and repeating the operation of the last step if the capacitor voltage does not reach the threshold value.

S5: and judging whether the resistance applied to the human body is larger than a set value or not. If the resistance is larger than the set value, an operator is reminded through sound and light alarm, and if the resistance is not larger than the set value during intervention and the target lesion is successfully reached, the balloon 100 is inflated by the inflation liquid 110.

S6: the handle button of the operation handle 580 is pressed.

S7: and judging whether the short circuit occurs. The high voltage generation processing device 500 detects whether the circuit is short-circuited. If a short circuit is detected, the discharge is immediately ended, and if no short circuit is detected, the next step is proceeded to.

S8: and (4) discharging.

S9: and judging whether the hydraulic pressure and the temperature are greater than set values. Wherein the hydraulic pressure represents a filling pressure. The step S9 of determining whether the hydraulic pressure and the temperature are greater than the set values may be performed simultaneously with the discharging step of the step S8. If the hydraulic pressure and the temperature are larger than set values, discharging is finished; and if the hydraulic pressure and the temperature are not greater than the set values, the previous step is carried out.

Further, referring to fig. 6, in order to reduce the risk of the patient undergoing a surgery such as transient ventricular capture or shock, the high voltage generation processing device 500 further includes a safety operation flow.

S10: and starting. Signaling filling of balloon 100.

S11: the balloon is inflated.

S12: and judging whether the specified hydraulic pressure is reached. If the pressure inside the balloon 100 reaches a set threshold, for example, 4 standard atmospheres (4atm), the next step is performed; if the balloon 100 reaches the set threshold, the last step is entered.

S13: the activation timer starts timing.

S14: and judging whether the time limit is reached. If the timing time limit reaches a set value, for example, 10 seconds, entering the next step; and if the timing time limit does not reach the set value, the last step is carried out.

S15: and sound and light warning. The operator can draw back the filling liquid 110 in the balloon 100 according to the sound and light warning, so that the safety of the operation is improved.

The first embodiment further provides an electrode assembly 320, and the electrode assembly 320 of the first embodiment will be described in detail with reference to fig. 1, fig. 7a and fig. 7 b. The electrode assembly 320 is used in an electrode balloon catheter, and it should be understood that the electrode assembly 320 may be applied to the electrode balloon catheter as described above, and may also be used in other electrode balloon catheters, such as those employing inflexible positive and negative electrode wires. The electrode part 320 includes: a first electrode 3201, a second electrode 3202, and a receiving structure 3203.

As shown in fig. 7a, the first electrode 3201 is preferably an annular structure, for example, disposed circumferentially around an electrode balloon catheter, such as the inner catheter 200, which may be around an electrode balloon catheter as described above. Of course, the first electrode 3201 may also be disposed around other electrode balloon catheters. The first electrode 3201 may have other shapes, such as a rectangular sheet-like structure, or may have a sheet shape such as a patch, and is disposed on the inner catheter 200.

With reference to fig. 7a, the receiving structure 3203 may be, for example, a circular structure, the receiving structure 3203 is disposed on the first electrode 3201, preferably penetrates through the receiving structure 3203 disposed on the first electrode 3201, and in other embodiments, the receiving structure 3203 may also be disposed on the surface of the first electrode 3201. The receiving structure 3203 may be disposed at a side end of the first electrode 3201, or may be disposed at a middle position of the first electrode 3201. Of course, the receiving structure 3203 may also be in a shape of a rectangle, a square, a diamond, a triangle, or the like, the shape, size, and position of the receiving structure 3203 may be determined according to the position, direction, and size of the desired shock wave, and those skilled in the art may set the shape according to actual requirements, and the shape of the receiving structure 3203 is not limited in this embodiment.

With reference to fig. 7a, at least a portion of the second electrode 3202 is disposed in the accommodating structure 3203, so that electrode discharge between the second electrode 3202 and the first electrode 3201 can be discharged between the same layers, and the electrode components 320 are arranged in a single layer, thereby reducing the passing size of the electrode balloon catheter, making the passing size closer to the size of the pre-expanded balloon, avoiding the use of an electrode structure with stacked arrangement of discharge among stacked layers, and preventing the electrode balloon catheter from being difficult to pass or even being broken when the electrode balloon catheter is inserted. The first electrode 3201 and the second electrode 3202 are arranged at intervals, and the interval between the first electrode 3201 and the second electrode 3202 is ensured to be used for filling with filling liquid, so that the first electrode 3201 and the second electrode 3202 are of a single-layer electrode structure separated in parallel, and the passing size of the electrode balloon catheter is reduced. The second electrode 3202 is preferably disposed in a sheet shape, for example, one of the first electrode 3201 and the second electrode 3202 is the positive electrode 321, the other is the negative electrode 322, and the first electrode 3201 and the second electrode 3202 are used for electrically connecting with a high voltage generating and processing device 500. In the first embodiment, the first electrode 3201 is the positive electrode 321, and the second electrode 3202 is the negative electrode 322, in other embodiments, the first electrode 3201 may also be the negative electrode 322, and the second electrode 3202 may also be the positive electrode 321.

Further, as shown in fig. 7a, the shape of the at least a portion of the second electrode 3202 matches the shape of the receiving structure 3203. For example, the receiving structure 3203 has a circular structure, the at least part of the second electrode 3202 has a circular structure, the receiving structure 3203 has a square structure, and the at least part of the second electrode 3202 has a square structure. Of course, the second electrode 3202 may be at least partially disposed in the receiving structure 3203, or may be entirely disposed in the receiving structure 3203.

Preferably, as shown in fig. 7a, at least two receiving structures 3203 are disposed on each first electrode 3201, and each receiving structure 3203 is disposed to match with one second electrode 3202, so that one first electrode 3201 is disposed and at least two shock wave generating points are satisfied, the number of first electrodes 3201 is reduced, and the shock wave generating efficiency is improved.

Preferably, the first electrode 3201 and/or the second electrode 3202 are disposed on an electrode balloon catheter by means of pasting, printing, electroplating, 3D printing or vapor deposition, for example, the inner catheter 200 of the electrode balloon catheter as described above is preferably disposed, but may be disposed on other electrode balloon catheters. The carrier, such as the inner catheter 200, may also have an insulating connector 3204. More preferably, the first electrode 3201 and/or the second electrode 3202 are respectively formed directly with the flexible circuit layer 310. In this embodiment, the second electrode 3202 and the flexible circuit layer 310 are directly molded together, so that the second electrode 3202 has the beneficial effects of the flexible circuit layer 310, and the description thereof is omitted here.

Preferably, the electrode assembly 320 further includes an insulating connecting member 3204, and the insulating connecting member 3204 is connected to the first electrode 3201 and the second electrode 3202, respectively, for fixing the relative positions of the first electrode 3201 and the second electrode 3202. In the first embodiment, the insulating connecting member 3204 is used to fix the second electrode 3202, such that the second electrode 3202 is spaced apart from the first electrode 3201, so as to discharge the filling liquid 110 between the first electrode 3201 and the second electrode 3202. Further, as shown in fig. 7b, the second electrode 3202 is fixedly connected with the insulating connecting member 3204, the insulating connecting member 3204 is clamped to the first electrode 3201, the insulating connecting member 3204, the first electrode 3201 and the second electrode 3202 are all arranged on the same layer on an electrode balloon catheter, for example, preferably on the inner catheter 200 of the electrode balloon catheter, and of course, may also be arranged on other electrode balloon catheters, so that the first electrode 3201 and the second electrode 3202 are arranged on the same layer and separately along the inner catheter 200, thereby ensuring that the electrode components 320 are arranged in a single layer, and reducing the passing size of the electrode balloon catheter. Specifically, the first electrode 3201 is provided with a first connection port a, for example, a groove; the insulating connecting member 3204 is provided with a second connection port B and a third connection port C, which are, for example, protrusions; the second electrode 3202 is provided with a fourth connection port D. The second connector B is connected with the first connector A in a clamping mode, and the insulating connecting piece 3204 and the first electrode 3201 are connected and fixed. The third connection port C is connected to the fourth connection port D, and the insulating connection member 3204 is connected to and fixed to the second electrode 3202. More specifically, two first connecting ports a are disposed on the same side of the first electrode 3201; the insulating connecting piece 3204 is arranged in a shape of a Chinese character 'shan', two second connecting ports B protrude from two sides of the insulating connecting piece in the shape of the Chinese character 'shan', and a third connecting port C protrudes from the middle of the insulating connecting piece in the shape of the Chinese character 'shan'; the second electrode 3202 is provided with a fourth connection port D on the same side as the first electrode 3201. The arrangement is such that a gap is formed between the first electrode 3201 and the second electrode 3202 to ensure that no short circuit is touched between the two electrodes. In fact, when a shock wave occurs between the positive electrode and the negative electrode, the shock wave is perpendicular to the plane where the negative electrode discharges to the positive electrode, i.e. perpendicular to the plane shown in fig. 7a, the first electrode 3201 and the second electrode 3202 are arranged in the same layer to discharge, so that the release direction of the shock wave is improved, and the shock wave can reach the focal site more efficiently. Preferably, the insulating connecting member 3204 is made of a flexible material having good heat insulating properties and high insulating ability, and is preferably made of Polytetrafluoroethylene (PTFE), Polyimide (PI), or the like.

As shown in fig. 9, further, the surface of the first electrode 3201 and/or the second electrode 3202 has micron-sized tips 3205, and the tips 3205 are in a group peak shape. The diameter and the height of the tip 3205 are both micron-sized, and preferably, the height of the tip 3205 is between 1 and 100 microns. It is understood that the concave-convex structure may be formed by performing micron-scale processing on the surface of the first electrode 3201 and/or the second electrode 3202. Preferably, with continued reference to fig. 9, the surface of the negative electrode 322 has a micron-sized tip 3205. The tips 3205 are, for example, perpendicular to the surface of the electrode, and when discharging, due to the electrohydraulic effect, the energy density of the group peak-shaped tips 3205 formed through micron-sized processing is higher, so that the release strength of the shock wave is improved, and the efficiency of breaking calcified lesions is improved. During discharge, the negative electrode generates an electric spark which is discharged towards the positive electrode, the surface of the negative electrode is preferably treated in a micron order, and the energy density can be obviously increased. In other embodiments, the positive electrode may also be processed on a micron scale. In the present embodiment, the second electrode 3202 is the negative electrode 322, and the surface of the second electrode 3202 has a micrometer-sized tip 3205. Of course, the first electrode 3201 and/or the second electrode 3202 may also adopt nano-scale processing, and the filling liquid 110 may also generate an electrohydraulic effect by adopting the nano-scale processing, and the principle thereof is the same as that of the micro-scale processing, and thus, the details thereof are not repeated herein.

[ example two ]

Referring to fig. 8a to 8b, fig. 8a is a schematic view of an electrode assembly according to a second embodiment and a third embodiment of the present invention; fig. 8b is another schematic view of the electrode assembly according to the second and third embodiments of the present invention.

The electrode member of the second embodiment is not described again in the same manner as in the first embodiment, and only different points will be described below.

As shown in fig. 8a and 8b, the insulating connecting member 3204 is laid on the receiving structure 3203, and the second electrode 3202 is disposed on the insulating connecting member 3204, such that the electrode member 320 is also disposed on the inner catheter 200 in a single layer structure, thereby reducing the passing size of the electrode balloon catheter. Similarly, the first electrode 3201 and the second electrode 3202 are discharged in the same layer. Further, the receiving structure 3203 is directly disposed on the surface of the first electrode 3201. In the second embodiment, the receiving structure 3203 is disposed on the surface of the first electrode 3201 to form a structure similar to a trench. The insulating connecting member 3204 is laid on the receiving structure 3203, and the second electrode 3202 is embedded in the receiving structure 3203 and is mounted on the insulating connecting member 3204. Similarly, a gap exists between the first electrode 3201 and the second electrode 3202. In other embodiments, the receiving structure 3203 may be disposed through the first electrode 3201, for example, the first electrode 3201 is attached to the inner conduit 200, the insulating connecting member 3204 is disposed directly on the receiving structure 3203 and is also attached directly to the inner conduit 200, and the second electrode 3202 is disposed on the insulating connecting member 3204. Of course, the first electrode 3201 is directly attached to the inner catheter 200, the second electrode 3202 is also directly attached to the inner catheter 200, and the insulating connecting member 3204 is disposed in the gap between the first electrode 3201 and the second electrode 3202 to avoid short circuit. The first electrode 3201 and the second electrode 3202 are respectively connected to a high voltage generating and processing device through an electrode wire E, it should be understood that the electrode wire E includes a positive electrode wire and a negative electrode wire, the positive electrode is connected to the positive electrode wire, and the negative electrode is connected to the negative electrode wire.

The electrode balloon catheter in the first embodiment may include one or more electrode members 320, and when a plurality of electrode members 320 are included, the electrode members 320 in the first embodiment may be used, or the electrode members 320 in the second embodiment may be used.

[ EXAMPLE III ]

Fig. 7a is a schematic view of an electrode assembly according to a first embodiment and a third embodiment of the present invention. Fig. 7b is another schematic view of the electrode assembly according to the first and third embodiments of the present invention. Fig. 8a is a schematic view of an electrode assembly according to a second embodiment and a third embodiment of the present invention. Fig. 8b is another schematic view of the electrode assembly according to the second and third embodiments of the present invention.

The electrode member of the third embodiment is not described again in the same manner as in the first and second embodiments, and only different points will be described below.

Referring to fig. 7a to 8b, an electrode assembly 320 provided in this embodiment is used for an electrode balloon catheter, where the electrode assembly 320 includes: a first electrode 3201 and a plurality of second electrodes 3202.

The first electrode 3201 has a plurality of receiving spaces 3203, and the receiving spaces 3203 are used for respectively embedding at least a portion of each second electrode 3202 in the plurality of second electrodes 3202. The plurality of second electrodes 3202 are, for example, two or three. The plurality of housing spaces 3203 are, for example, two, three, or four. Preferably, the number of the second electrodes 3202 is equal to the number of the receiving spaces 3203. At least a portion of each second electrode 3202 can be accommodated in each accommodation space 3203. Of course, all of each of the second electrodes 3202 can be accommodated in each of the accommodating spaces 3203, and those skilled in the art can set the shape, the area, etc. of the second electrodes 3202 accommodated in the accommodating spaces 3203 according to actual requirements.

The first electrode 3201 and the second electrode 3202 are spaced apart, and the area of the first electrode 3201 is larger than that of the second electrode 3202, so that the second electrode 3202 can be always accommodated in the first electrode 3201. With such an arrangement, the beneficial effects of the motor component 320 can be obtained with reference to the first embodiment, which is not described herein again.

One of the first electrode 3201 and the second electrode 3202 is a positive electrode, and the other is a negative electrode; the first electrode 3201 and the second electrode 3202 are used for electrically connecting with a high voltage generating and processing device, and the contents of the first electrode 3201 and the second electrode 3202 are the same as those of the first embodiment, and are not repeated herein.

As shown in fig. 7a to 8b, referring to fig. 7a in particular, preferably, the first electrode 3201 is a ring-shaped structure and is sleeved on the electrode balloon catheter, the second electrode 3202 is a circular sheet, and the plurality of second electrodes 3202 are uniformly arranged along the circumferential direction of the first electrode 3201, so that the discharge points between the positive and negative electrodes can be uniformly discharged, and the balloon 100 can be uniformly expanded along the circumferential direction of the first electrode 3201. In the third embodiment, the number of the second electrodes 3202 is two, and the two second electrodes 3202 are uniformly arranged along the circumferential direction of the first electrode 3201.

Preferably, as shown in fig. 7a and 8b, the first electrode 3201 and the second electrode 3202 are fixed in relative positions by an insulating connecting member 3204. The insulating connecting member 3204 enables insulation between the first electrode 3201 and the second electrode 3202 on the one hand, and has a role of a fixing bracket on the other hand.

Preferably, as shown in fig. 8a, the insulating connecting member 3204 is laid in the accommodating space 3203, and the second electrode 3202 is disposed on the insulating connecting member 3204, thereby laying a foundation for disposing the second electrode 3202 and the first electrode 3201 in the same layer.

In summary, the present invention provides an electrode assembly and an electrode balloon catheter, wherein the electrode assembly comprises: a first electrode, a second electrode and a receiving structure; the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals; one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device. So set up for the electrode part arranges for the individual layer, has reduced the size that passes through of electrode sacculus pipe, makes the size that passes through of electrode sacculus pipe thinner, and the size that more is close to the sacculus of expanding in advance prevents that when electrode sacculus pipe from mediating, the phenomenon of taking place to be difficult to through even the subassembly rupture.

The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure are all within the scope of the claims.

Claims (16)

1. An electrode assembly for an electrode balloon catheter, comprising: a first electrode, a second electrode and a receiving structure;

the accommodating structure is arranged on the first electrode, at least part of the second electrode is arranged in the accommodating structure, and the first electrode and the second electrode are arranged at intervals;

one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device.

2. The electrode component of claim 1, wherein a shape of the at least a portion of the second electrode matches a shape of the receiving structure.

3. The electrode assembly of claim 1, wherein the first electrode is an annular structure disposed about a circumference of the electrode balloon catheter and the second electrode is a sheet-like structure.

4. The electrode assembly of claim 1, wherein at least two receiving structures are disposed on each first electrode, each receiving structure being configured to mate with a respective one of the second electrodes.

5. The electrode component of claim 1, wherein the first electrode and/or the second electrode is disposed on the electrode balloon catheter by means of pasting, printing, electroplating, 3D printing or vapor deposition.

6. The electrode assembly of claim 1, further comprising insulating connectors connected to the first and second electrodes, respectively, for fixing the relative positions of the first and second electrodes.

7. The electrode assembly of claim 6, wherein the second electrode is fixedly connected to the insulating connector, the insulating connector is snapped onto the first electrode, and the insulating connector, the first electrode, and the second electrode are all disposed on the same layer on the electrode balloon catheter.

8. The electrode assembly of claim 6, wherein the insulating connector is disposed on the receiving structure and the second electrode is disposed on the insulating connector.

9. The electrode assembly of claim 8, wherein the receiving structure is disposed through the first electrode or is disposed on a surface of the first electrode.

10. The electrode component of claim 1, wherein the surface of the first electrode and/or the second electrode has micron-sized tips, the tips being in the shape of a group peak.

11. An electrode component for an electrode balloon catheter, the electrode component comprising: a first electrode and a plurality of second electrodes;

the first electrode is provided with a plurality of accommodating spaces which are used for being respectively embedded into at least part of each second electrode in the plurality of second electrodes, the first electrode and the second electrodes are arranged at intervals, and the area of the first electrode is larger than that of the second electrodes;

one of the first electrode and the second electrode is a positive electrode, and the other is a negative electrode; the first electrode and the second electrode are used for being electrically connected with a high voltage generation processing device.

12. The electrode assembly of claim 11, wherein the first electrode is an annular structure and is disposed on the electrode balloon catheter, the second electrode is a circular sheet, and the plurality of second electrodes are uniformly arranged along a circumferential direction of the first electrode.

13. The electrode assembly of claim 11 wherein said first electrode and said second electrode are secured in relative position by an insulating connector.

14. The electrode assembly of claim 13, wherein the insulating connector is disposed in the receiving space, and the second electrode is disposed on the insulating connector.

15. An electrode balloon catheter, comprising: a balloon, an inner catheter, and an electrode component according to any one of claims 1-14;

the balloon is sleeved outside the inner catheter and expands or contracts along the radial direction under the filling and extraction of filling liquid;

the electrode component is arranged on the inner catheter, is positioned in the balloon and is used for being connected with a high-voltage generation processing device.

16. The electrode balloon catheter according to claim 15, further comprising a flexible circuit layer disposed on the inner catheter; the flexible circuit layer is respectively connected with the first electrode and the second electrode, and the first electrode and the second electrode are connected with the high-voltage generation processing device through the flexible circuit layer.

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