A urethral catheter and device with conductive structures

Abstract

The application is a urethral catheter with conductive structure, which comprises a flexible catheter, the flexible catheter enters the human bladder through the urethra, the outer surface of the flexible catheter is partially provided with a conductive structure, the conductive structure is arranged at the prostate part of the outer distal end of the flexible catheter to assist freezing and electric ablation, the flexible catheter is internally provided with a liquid guide channel and a liquid guide opening is arranged at the distal end of the flexible catheter, the urethral catheter has a temperature protection effect, a temperature protection channel is divided into a liquid inlet channel and a liquid outlet channel by an inner sleeve and an outer sleeve, a surface electrode on the outer wall of the inner sleeve is connected to the circuit of a host, and the conductive structure only conducts electricity and does not have an electrochemical reaction. The application is used for cooperating to complete electric effect or electric ablation diagnosis and treatment effect and freezing, radio frequency and microwave and other thermal ablation, can avoid cold and hot damage or electric damage to the urethra or the prostate, has a temperature adjusting function and a simple structure and is easy to adjust and control.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a urethral catheter and device with conductive structure. BACKGROUND

[0002] The urethral catheter does not have other additional functions, and it is the development direction of the field to ablate or assist in ablation of the target area while catheterizing. Ablation techniques include cryoablation (argon-helium freezing, liquid nitrogen freezing, carbon dioxide freezing, laughing gas freezing, etc.), thermal ablation (radiofrequency ablation, microwave ablation, laser ablation, ultrasound focused ablation, infrared ablation, electric heating ablation, etc.), electric ablation (electrochemical ablation, electric pulse ablation and TTF alternating electric field), and other local ablation methods (such as low-temperature plasma, ozone, etc.). Most of the ablation techniques will inactivate tumor tissue by cold and heat effects.

[0003] Cold and heat ablation of tumors adjacent to or surrounding natural cavities of the human body (such as airway, digestive tract, urethra, reproductive tract, nasal cavity, etc.) often causes frostbite or burn of the natural cavities of the human body; or the tumor ablation is not complete due to consideration of body cavity damage; electric ablation of the natural cavities of the human body will produce a large amount of electrochemical products at the target position, which will threaten the natural cavities of the human body. The current commonly used method is to rely on image positioning to avoid damage to the natural cavities of the human body, but the operation is difficult, has many complications, and has large tumor residue. SUMMARY

[0004] To solve the existing problems, the present application provides a urethral catheter and device with conductive structure, which combines direct or assisted ablation capabilities, including electric ablation and cold ablation, to directly or assist in ablation of the bladder or prostate while catheterizing and effectively protect the urethra.

[0005] The present application selects a urethral catheter with conductive structure, which includes a flexible catheter, the flexible catheter enters the human bladder through the urethra, a part of the surface of the flexible catheter is provided with a conductive structure, the conductive structure is arranged on the outer distal end of the flexible catheter and acts on the prostate part to assist in electrochemical ablation; a liquid guiding channel is arranged in the flexible catheter, and a liquid guiding opening is arranged at the distal end of the flexible catheter; a temperature protection channel is further arranged in the interior of the flexible catheter, the temperature protection channel is adjacent to the liquid guiding channel, the temperature protection channel is divided into a temperature protection liquid inlet channel and a temperature protection liquid outlet channel by a barrier wall; an electrode is arranged on the barrier wall and / or the inner wall of the temperature protection channel; the conductive structure only conducts electricity and does not have electrochemical reaction at the position of the conductive structure.

[0006] Further, the material selected for the conductive structure and / or the electrode is an electrochemically inert material.

[0007] Further, the electrochemically inert material is graphite material.

[0008] Further, the surface of the conductive structure is provided with a protective layer for neutralizing electrochemical products.

[0009] Further, the conductive structure and the electrode can be used for electric heating.

[0010] Further, the distal end of the flexible catheter is provided with a balloon-shaped expansion cavity in communication with the temperature protection channel, and the balloon-shaped expansion cavity is used for fixing the position of the flexible catheter.

[0011] Further, the urethral catheter further comprises a temperature sensor arranged on the surface of the urethral catheter for detecting the temperature of the contact site.

[0012] Further, the urethral catheter further comprises a temperature sensor connected to the conductive structure.

[0013] The application further provides a host suitable for the flexible catheter, which comprises a freezing generator, a heating generator, a fluid supply device, a temperature control device and an electric generator, the freezing generator and the heating generator cooperate to adjust the temperature of the fluid of the fluid supply device to the required protection temperature of the urethra under the control of the temperature control device, the fluid supply device is in communication with the liquid guide channel and the temperature protection channel; the electric generator is used for assisting electrochemical ablation, and the electrochemical ablation comprises electrolytic ablation and / or electric pulse ablation.

[0014] Further, the electric generator can apply an alternating current, and the alternating current is used for generating a TTF treatment field.

[0015] The application has the following advantages: (1) assisting the tumor ablation instrument to complete electrochemical and / or cryogenic ablation;

[0016] (2) avoiding electrochemical damage to the urethra, bladder or prostate when electrochemical ablation is performed;

[0017] (3) having a temperature adjusting function and a simple structure easy to control. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is the overall cross-sectional schematic view of the balloon flexible catheter of the application

[0019] Figure 2 is the overall cross-sectional schematic view of the balloon flexible catheter of the application with a heating wire

[0020] Figure 3 is the AA' direction cross-sectional schematic view of the balloon flexible catheter of the application

[0021] Figure 4 is the schematic diagram of the overall profile of the flexible catheter of the present application

[0022] Figure 5 is the schematic diagram of the BB' direction cross-section of the balloon flexible catheter of the present application

[0023] Figure 6 is the schematic diagram of the working use of the present application

[0024] Figure 7 is the block diagram of the host computer, catheter and cooperating equipment of the present application

[0025] Figure 8 is the radial cross-section along the urethra of the present application and the ablation probe cooperating

[0026] Figure 9 is the axial cross-section along the urethra of the present application and the ablation probe cooperating

[0027] Figure 10 is the schematic diagram of the cross-section of the conductive structure of the present application

[0028] In the figure: 1 - balloon flexible catheter, 101 - liquid guiding channel, 1011 - liquid guiding port, 1012 - fluid output port, 102 - temperature protection liquid inlet channel, 1021 - fluid inlet port, 103 - balloon-like inflation cavity, 1031 - balloon fluid channel, 1032 - balloon fluid guiding port, 104 - temperature protection liquid outlet channel, 1041 - conductive structure, 10411 - conductive gel, 10412 - conductive through hole, 1042 - electrode, 1043 - electrode lead wire, 1044 - temperature measuring wire, 1045 - heating lead wire, 2 - flexible catheter, 201 - second liquid guiding channel, 2011 - second liquid guiding port, 2012 - second fluid output port, 202 - second second temperature protection liquid inlet channel, 2021 - second fluid inlet port, 203 - second temperature protection liquid outlet channel, 2031 - second conductive structure, 2032 - second conductive structure protection layer DETAILED DESCRIPTION:

[0029] The present application is mainly used for ablation of lesions in the bladder and / or prostate. The present application enters the bladder through the urethra, and the flexible catheter part is arranged in the urethra and the distal end is arranged in the bladder. The ablation method selected can be independent or combined, including cold ablation, heat ablation or electric effect treatment (including electric chemical, electric pulse, alternating electric field, etc. using electric field, electric current or voltage of electric effect). Specifically, the present application is provided with a fluid cavity. According to the difference of the cold fluid or hot fluid flowing into the fluid cavity, the lesions can be cold ablated or heat ablated. The conductive part arranged outside the present application can be electrified for electric ablation. The electric ablation is divided into electric chemical ablation and / or electric pulse ablation, and the two can be used in combination. When electric chemical ablation is carried out, at least two electrodes are required. Therefore, two or more electrodes can be arranged on the present application, or one electrode can be arranged. However, attention should be paid to the problem that the electric chemical product generated by electrode corrosion is toxic. One method adopted by the present application is to avoid direct contact of the electrode with the human body. The conductive structure is indirectly used for conducting electricity in the action area, or the electrode made of materials such as graphite, graphene, carbon fiber or conductive ceramics (i.e. the electric chemical inert material) is used, or the solution or gel material for neutralizing the electric chemical product is arranged on the present application or used in combination. The conductive structure only conducts electricity but does not cause electric chemical reaction, including electrolytic reaction, at the position of the conductive structure. The specific embodiments can be referred to as follows.

[0030] Embodiment: Reference Figure 1 and Figure 3 , Figure 1 is a cross-sectional view of a balloon flexible catheter 1, Figure 3 is a cross-sectional view of a balloon flexible catheter 1 of the present application. The balloon flexible catheter 1 is internally provided with a liquid guide channel 101. The distal end of the balloon flexible catheter 1 is provided with at least one liquid guide opening 1011 for connecting the liquid guide channel 101. The liquid guide channel 101 can input liquid into the bladder or extract liquid in the bladder. The specific function is generally to clean the liquid in the bladder or to flush the bladder with liquid. The overall outer surface of the balloon flexible catheter 1 is a flexible structure. For example, latex material can be used as the outer structure. The selected material can be replaced by other plastic materials, but the biological compatibility should be ensured. In this embodiment, the distal end is provided with a component for fixing the position of the present application. Specifically, in this embodiment, it is a balloon-shaped inflation cavity 103. It should be noted that the balloon-shaped inflation cavity 103 can be a balloon disclosed for use in the present application, or it can be only an inflation cavity (with a part of the convex or easily convex outer wall, which is easier to be filled with liquid and inflated). The balloon-shaped inflation cavity 103 can be filled with fluid to keep it inflated after entering the bladder through the urethra, so that the present application does not fall off. It should be noted that this structure is not necessary. The structure without the balloon-shaped inflation cavity 103 can be referred to as Figure 4, select as shown in the structure can still complete the main function of the application. The fluid into the balloon-like inflation cavity 103 can be gas or liquid, can be low temperature, high temperature or normal temperature, normal temperature fluid only as the balloon inflation, specifically can be any safe ( generally refers to biocompatible and non-toxic harmless) fluid, in this embodiment to the balloon-like inflation cavity 103 inside the supply channel is temperature protection liquid inlet channel 102, the corresponding balloon-like inflation cavity 103 inside the fluid discharge channel is temperature protection liquid outlet channel 104, separated by a barrier wall between the two, and both can be reversed, namely: the overall outer layer is set as temperature protection liquid outlet channel 104 inner layer is set as temperature protection liquid inlet channel 102, this exchange does not affect the implementation of the present application, the barrier wall or the temperature protection liquid outlet channel 104 is provided with at least one electrode 1042, the electrode 1042 is connected with the electrode lead 1043, the electrode lead 1043 transmits the electrochemical ablation signal to the electrode 1042, the electrochemical ablation signal can be an electric pulse signal and / or an electrochemical signal, the electrode can apply an alternating current to the lesion, the alternating current is used to generate a TTF treatment field (tumor treatment electric field); therefore the fluid supplied inside the balloon-like inflation cavity 103 should have conductivity, to ensure safety should also have biocompatibility, such as: normal saline; in order to guide the current to the human body, the present application also provides a conductive structure 104, the conductive structure 1041 and the electrode 1042 are preferably made of inert materials, for example: graphite; except the conductive structure 1041, the rest of the part in contact with the human body is electrically insulated, the conductive structure 1041 can refer to Figure 10 , Figure 10 is a conductive structure of an optional form, which is to pass the outer surface of the balloon flexible catheter 1 through at least one conductive through hole 10412 and attach a conductive body, such as: conductive gel 10411, to the hollow part and both sides of the conductive through hole 10412. This structure can make the fluid flowing in the cavity conduct electricity after the electrode 1042 is charged, so that the conductive structure 1041 is charged and further promotes the effect of auxiliary electrochemical ablation. It should be noted that the sealing of this part prevents liquid leakage. By using this structure, the conductive gel 10411 can be adjusted to have a protective layer that neutralizes electrolytic products. This structure allows electrolytic products accumulated near the conductive structure to be neutralized by the protective conductive gel 10411. The conductive structure 104 can also be provided on the surface of the balloon-like inflation cavity 103.

[0031] The present embodiment also has a temperature measuring line 1044, which is preferably provided on the electrode 1042 or the conductive structure 1041. When the temperature measuring line 1044 is provided on the electrode 1042, reference Figure 2, the heating wire 1045 should be connected to the electrode 1042, so that the temperature measuring wire 1044 can accurately detect the temperature of the heating source. In the case of the structure of the heating wire 1045, the above-mentioned fluid (i.e. the fluid introduced into the balloon-shaped inflation cavity 103) can be temperature-controlled through the heating wire 1045; when the temperature measuring wire is arranged on the 1044, the reference Figure 1 The temperature measuring method can directly detect the temperature of the conductive structure 1041 in contact with the human body to prevent damage to the urethra caused by excessive high or low temperature at this position; it should be noted that the above-mentioned temperature measuring method is the preferred method, and the temperature measuring point can be arranged anywhere on the balloon flexible catheter 1. The accuracy of the temperature measuring result data can be affected by heat loss, which can be avoided as much as possible through calculation.

[0032] Reference Figure 7 The balloon flexible catheter 1 is equipped with a main machine with low-temperature fluid and high-temperature fluid output, mainly relying on a refrigeration generator and / or a heat generator to cooperate with the temperature control device (temperature control heater) to supply fluid to the whole temperature control of the present application. This scheme only belongs to one of the optional schemes, and any technology suitable for fluid temperature rise or fall in the prior art can be selected for temperature control function, which is not limited here. The high-temperature fluid (which can balance the temperature to prevent excessive temperature through the refrigeration generator) is introduced into the temperature protection liquid inlet channel 102 to protect the urethra, and then enters the balloon-shaped inflation cavity 103 to fill the balloon-shaped inflation cavity 103 to prevent the balloon flexible catheter 1 from falling off, and then is discharged through the temperature protection liquid outlet channel 104. The process of fluid introduction and discharge of the temperature protection channel can be completed by a peristaltic pump, or by other means disclosed.

[0033] The main machine in this embodiment has a temperature control heater, so that the main machine can accept the temperature signal detected by the temperature measuring wire 1044, and adjust the temperature of the input fluid manually or automatically through the main machine, so as to ensure that the fluid supplied by the fluid supply device will not damage the urethra, prostate or bladder, etc. Position, ensure that the heating wire 1045 does not overheat the electrode 1042.

Claims

1. A urethral catheter with a conductive structure, comprising a flexible catheter, which enters the human bladder through the urethra, characterized in that: A conductive structure is provided on a portion of the surface of the flexible catheter, and the conductive structure is arranged at the distal end of the flexible catheter to act on the prostate to assist electrochemical ablation; a liquid guide channel is provided inside the flexible catheter, and a liquid guide port is opened at the distal end of the flexible catheter; a temperature protection channel is also provided inside the flexible catheter, and the temperature protection channel is adjacent to the liquid guide channel, and the temperature protection channel is divided into a temperature protection liquid inlet channel and a temperature protection liquid discharge channel by a barrier wall; Electrodes are provided on the barrier tube wall and / or the inner wall of the temperature protection channel, and electrode wires are connected to the electrodes. The electrode wires transmit electrochemical ablation signals to the electrodes. The electrochemical ablation signals are electric pulse signals and / or electrochemical signals. The conductive structure only conducts electricity and no electrochemical reaction occurs at the position of the conductive structure. A protective layer is provided on the surface of the conductive structure, and the protective layer is used to neutralize electrochemical products. The outer surface of the flexible catheter passes through at least one conductive through-hole and a protective layer is attached to the hollow part and both sides of the conductive through-hole.

2. The urethral catheter according to claim 1, characterized in that: The material selected for the conductive structure and / or the electrode is an electrochemically inert material.

3. The urethral catheter according to claim 2, characterized in that: The electrochemically inert material is graphite.

4. The urethral catheter according to claim 1, characterized in that: The protective layer is conductive gel.

5. The urethral catheter according to claim 1, characterized in that: The conductive structure and electrodes can be used for electrical heating.

6. The urethral catheter according to claim 1, characterized in that: A balloon-shaped expansion cavity is provided at the distal end of the flexible catheter. The balloon-shaped expansion cavity is communicated with the temperature protection channel. The balloon-shaped expansion cavity is used to fix the position of the flexible catheter.

7. The urethral catheter according to claim 1, characterized in that: The urethral catheter further includes a temperature sensor, which is arranged on the surface of the urethral catheter and is used to detect the temperature of a contact part.

8. The urethral catheter according to claim 1, characterized in that: The urethral catheter further includes a temperature sensor connected to the conductive structure.

9. A host device for use with the urethral catheter according to any one of claims 1 to 8, characterized in that: It includes a freezing generator, a heat generator, a fluid supply device, a temperature control device and an electric generator. The freezing generator and the heat generator cooperate to adjust the fluid temperature of the fluid supply device to the required protection temperature of the urethra under the control of the temperature control device. The fluid supply device is connected to the liquid guide channel and the temperature protection channel; the electric generator is used to assist electrochemical ablation, and the electrochemical ablation includes electrolytic ablation and / or electric pulse ablation.

10. The main unit of the urethral catheter according to claim 9, characterized in that: The electrical generator can apply an alternating current, which is used to generate a TTF treatment field.

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