CN219422946U - Electric therapeutic device based on closed-loop freezing - Google Patents

Abstract

The utility model relates to an electric therapeutic device based on closed-loop refrigeration, which comprises at least one electric cold ablation needle connected with the electric therapeutic device, wherein the electric cold ablation needle comprises a needle handle, a needle rod and a needle point; the outlet of the liquid inlet pipe forms an expansion chamber in the needle tip, and the interlayer of the needle rod and the liquid inlet pipe forms an air return cavity. The closed loop refrigeration module is used for delivering the refrigerant to the electric cold ablation needle, controlling the circulation of the refrigerant and refrigerating the target area; and the electric treatment module is electrically connected with the needle point and used for transmitting electric treatment energy to the target tissue. The utility model realizes cryoablation by utilizing a refrigerant closed cycle refrigeration mode; an electric cooling combined treatment mode is realized by combining the electric treatment mode; solves the difficult problems of refrigerant acquisition, use and leakage of the traditional freezing treatment equipment, facilitates the application of freezing and electric cooling treatment technology, ensures personnel safety, saves cost and is environment-friendly.

Description

Electric therapeutic device based on closed-loop freezing

Technical Field

The utility model belongs to the technical field of medical appliances, and particularly relates to an electric treatment device based on closed-loop refrigeration.

Background

Cryoablation is a method of destroying and ablating diseased tissue using ultra-low temperatures, and is also the earliest historically used diseased tissue ablation technique in humans. One is that liquid nitrogen cryosurgery devices using phase change refrigeration techniques, such as liquid nitrogen as a low temperature working medium (refrigerant) and heated nitrogen as a high temperature working medium (heating medium), are used to treat various tumors. Another most common is the use of gas-throttling refrigeration techniques, such as argon helium knives using high pressure argon freezing and helium re-warming, which have been widely used in cryoablation therapy for a variety of benign and malignant tumors. Since cryoablation therapy is a physical therapy, it is generally clinically safer, less painful for the patient and faster post-operative recovery. However, only the inner core part can be fully treated by freezing generated by pure cryosurgery treatment, the periphery of freezing does not have the capacity of ablation treatment, the freezing temperature is extremely high in the requirement of freezing, the temperature at the probe can be reduced to-165 ℃ generally below-150 ℃ by argon refrigeration, the freezing gases are sensitive to temperature change and are difficult to recover and only consume, in addition, the tank body for storing the freezing gases is large and heavy in size, the transportation is laborious and cannot keep complete sterility, the freezing gases cannot be recovered after being consumed in the using process and can only be discharged in the air, the infection of a patient can be caused, the environment can be polluted, and even some flammable gases can generate potential safety hazards such as laughing gas and the like.

The electric therapy is also a common technical means in tumor ablation technology, and is an ablation technology based on a direct-current electric field, an alternating-current electric field or a pulsed electric field, and comprises modes of electrolytic ablation, electroporation ablation, TTF tumor treatment electric field and the like. Electrolytic ablation has been used for as long as the 19 th century for minimally invasive tissue ablation, also known as electrochemical therapy (EChT) or electrotherapy, is a method of delivering direct current into a treatment area through an electric melting needle inserted in the treated tissue, causing local PH changes in the treatment area to create a cytotoxic environment, and some new chemicals formed during electrolysis to cause cell death. Electrolytic ablation requires a small direct current (several tens to several hundreds of milliamperes) and a low voltage (several tens to several volts), and thus causes a problem in that the therapeutic process of the electric treatment is long.

Therefore, the technology of cold-electric combination becomes an emerging tumor treatment mode in recent years, but the problem is that the cryoablation needs to be controlled at a temperature below-40 ℃, which is not conductive, and the electric treatment is still needed to be carried out after the rewarming, so that the effect brought by the traditional cold-electric combination for saving the treatment cost is not obvious; in natural environment, high-pressure argon and helium with high purity are difficult to obtain, and heavy high-pressure gas bottles are needed to store for maintaining high-pressure stability, so that great troubles are generated in the aspects of preparation, transportation and the like in the preparation stage of use, the technical defect of the existing cold-electricity combination is overcome, the treatment system which can not only meet the treatment effect of the cold-electricity combination, but also is not limited by heavy gas-liquid bottles, is convenient to use and does not generate pollution and potential safety hazard is provided, and the technical problem to be solved by the treatment system is urgent for the people in the field. .

Disclosure of Invention

In view of the above problems, it is an object of the present utility model to provide an electrotherapy device based on closed-loop freezing, comprising at least one interface, characterized in that it comprises:

at least one electric cold ablation needle is connected with the interface and used for conducting cold energy and electric energy, the electric cold ablation needle comprises a needle handle and a needle rod, the needle handle is connected with the needle rod, and a heat exchanger is arranged in the needle handle and used for exchanging heat of flowing-in liquid and flowing-out gaseous refrigerants; a needle tip, the needle tip being electrically and thermally conductive; and the sleeve is provided with a heat insulation layer and an insulating layer, the sleeve completely and conformally wraps the needle rod and the needle point from the outside, and the sleeve is electrically and thermally conductive between the needle point and external tissues and is detachably and fixedly connected with the needle handle.

A liquid inlet pipe for inputting or outputting liquid refrigerant from the electric treatment device frozen by closed loop to the electric cold ablation needle; an expansion chamber is formed from the outlet of the liquid inlet pipe to the inside of the needle point and is used for gasifying and absorbing heat of the refrigerant and carrying out heat exchange with the tissue through the needle point; the interlayer of the needle bar and the liquid inlet pipe forms an air return cavity channel for the gasified refrigerant to flow back into the device;

the closed-loop refrigeration module comprises a compressor and is used for compressing gasified refrigerant; a condenser for liquefying the compressed refrigerant; a liquid storage tank for separating the gaseous and liquid refrigerants, preventing the compressor from being hit by liquid, and storing the liquid refrigerant, and adjusting the liquid supply amount according to the load change; a filter for filtering impurities of the refrigerant; one end of the liquid pipe is connected with the liquid storage tank, and the other end of the liquid pipe is connected with the liquid inlet pipe and is used for conveying liquid refrigerant; one end of the air pipe is connected with the air return cavity of the electric cold ablation needle, and the other end of the air pipe is connected with the compressor and is used for recovering and conveying gasified refrigerant; the closed-loop refrigeration module comprises a four-way valve, and the four-way valve can reverse the flow direction of gaseous refrigerant compressed by the compressor, so that the refrigerant is condensed in the needlepoint expansion chamber to generate heat.

And the electric treatment module is electrically connected with the needle point and is used for delivering electric treatment energy to the electric cold ablation needle.

Further, the insulating layer region of the sleeve at least completely covers the region of the insulating layer of the sleeve.

Further, the electric cold ablation needle also comprises an air return pipe, and the air return pipe is used for inputting or outputting the gaseous refrigerant into or from the electric cold ablation needle by the closed-loop freezing electric treatment device.

Further, an outlet of the liquid inlet pipe, which is close to the needle point, is provided with an expansion port; the part of the liquid inlet pipe, which is close to the needle point, is provided with a heat exchanger.

Further, a heat exchanger is arranged at the part of the liquid inlet pipe close to the needle point.

Further, the electric cold ablation needle is a flexible catheter and/or a balloon, at least one electrode is arranged on the surface of the flexible catheter and/or the surface of the balloon, and the electrode is electrically connected with the electric treatment module.

Further, the electric cold ablation needle is also provided with a thermocouple, and the thermocouple is used for detecting the temperature of the electric cold ablation needle.

Further, a liquid inlet valve is arranged on the liquid pipe and is used for controlling the refrigerant liquid inlet amount of the electric cold ablation needle and closing the liquid inlet; the air pipe is provided with an air outlet valve for controlling the air outlet pressure of the gasified refrigerant of the electric cold ablation needle and closing after the refrigerant is emptied.

Further, a liquid outlet is arranged on the liquid storage tank and is used for flowing out the refrigerant; the liquid return port is used for returning the liquefied refrigerant; a filling port for replenishing the refrigerant; and an overflow port for safely overflowing the refrigerant when the pressure is too high due to too much refrigerant.

Further, the electrical therapy generation module includes at least an electrochemical generator, and/or an electrical pulse generator.

The utility model has the beneficial effects that: when a focus is ablated, an electric cooling ablation needle enters a focus area, then a liquid outlet of a liquid storage tank in a closed-loop refrigeration module is opened, a liquid inlet valve of a liquid pipe is opened, liquid refrigerant enters the liquid inlet pipe through the liquid pipe under the action of self pressure, and then is gasified and absorbed rapidly in an expansion chamber, so that the surface of a needle point of the electric cooling ablation needle is frozen, gasified gaseous refrigerant is conveyed to a compressor from an ablation needle return air channel through an air pipe, the compressor compresses the gaseous refrigerant and then conveys the gaseous refrigerant to a condenser, a liquid return port of the liquid storage tank is opened after the gaseous refrigerant is liquefied in the condenser, the liquid refrigerant flows back to the liquid storage tank again after being filtered by a filter, and a cycle of the refrigerant is completed, wherein the cycle process of freezing and icing which is expected is usually continued for a plurality of times;

after freezing and icing, the electric therapy module starts outputting electric energy to the electric cryoablation needles, if the freezing and icing temperature is too low, a circuit between the electric cryoablation needles cannot be communicated, a four-way valve is connected to change the flow direction of a refrigerant so as to heat the electric cryoablation needles to melt the freezing and icing, so that the circuit communication between the electric cryoablation needles is realized, the electric therapy of the focus between the ice layers is realized, in general, the effective electric therapy can be realized as long as the freezing and icing temperature is below the freezing point (0 ℃), and if the freezing and icing temperature is lower than (-21 ℃), the ablation circuit is out of circuit breaking, and the freezing and icing is heated to enable the ablation circuit to be communicated.

Therefore, the utility model realizes two processes of cryoablation and electrotherapy once, and the refrigerant in the cryoablation process realizes cyclic utilization, thereby ensuring the treatment effect, being safe and flexible and convenient to use, and in addition, the cyclic use of the refrigerant reduces the pollution and the potential safety hazard to the environment.

In addition, after each time of electric treatment is completed, a user can replace the electric cold ablation needle or replace a sleeve outside the electric cold ablation needle according to the requirement so as to ensure the safety and sterility of treatment.

The utility model realizes cryoablation by utilizing a refrigerant closed cycle refrigeration mode; an electric cooling combined treatment mode is realized by combining the electric treatment mode; solves the problems of refrigerant acquisition, transportation, storage, use and leakage, greatly facilitates the application of freezing and electric cold treatment technology, ensures personnel safety, avoids environmental pollution, saves cost and is environment-friendly.

Drawings

FIG. 1 is a schematic diagram of an electrotherapy device based on closed-loop refrigeration according to the present utility model;

FIG. 2 is a block diagram of an electrotherapy device based on closed-loop freezing in accordance with the present utility model;

FIG. 3 is a diagram of an embodiment of an outer jacket type cryoablation needle for an electrotherapy device based on closed loop freezing in accordance with the present utility model;

FIG. 4 is a split structure diagram of an electric treatment device jacket type electric cold ablation needle and a sleeve based on closed-loop freezing;

FIG. 5 is a view of another embodiment of an outer casing type cryoablation needle of an electrotherapy device based on closed loop freezing according to the present utility model;

FIG. 6 is a view of another embodiment of an outer casing type cryoablation needle of an electrotherapy device based on closed loop freezing according to the present utility model;

FIG. 7 is a view of another embodiment of an outer casing type cryoablation needle of an electrotherapy device based on closed loop freezing according to the present utility model;

FIG. 8 is a view of another embodiment of an outer casing type cryoablation needle of an electrotherapy device based on closed loop freezing according to the present utility model;

FIG. 9 is a detail view of an outer casing type electric cold ablation needle of an electric therapeutic device based on closed-loop freezing;

FIG. 10 is a diagram of a cold cycle based electrotherapy method according to the present utility model;

FIG. 11 is a diagram of a cold cycle based electrotherapy method according to the present utility model;

FIG. 12 is a detailed view of a cold cycle based electrotherapy method of the present utility model;

FIG. 13 is a detailed view of a cold cycle based electrotherapy method according to the present utility model;

FIG. 14 is a third diagram of an electrical treatment method based on a cold cycle according to the present utility model;

FIG. 15 is a diagram of a cold cycle based electrotherapy method according to the present utility model;

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The structures, proportions, sizes, etc. shown in the drawings attached hereto are for illustration purposes only and are not intended to limit the scope of the utility model, which is defined by the claims, but rather by the claims. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like recited in the present specification are merely for descriptive purposes and are not intended to limit the scope of the utility model, but are intended to provide relative positional changes or modifications without materially altering the technical context in which the utility model may be practiced.

In order that the above objects, features and advantages of the utility model will be readily understood, a more particular description of the utility model will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings.

As shown in figures 1-2 of the drawings,

the utility model provides an electrotherapy device based on closed-loop refrigeration, which comprises a host, wherein the host comprises a closed-loop refrigeration module and an electrotherapy module, and the host comprises at least one interface, and is characterized by comprising the following components:

at least one electric cold ablation needle 10 is connected with the interface and is used for conducting cold energy and electric energy, the electric cold ablation needle 10 comprises a needle handle 103, a needle rod 102 and a needle tip 101, at least part of the needle rod 102 is provided with a heat insulation layer 111 for insulating the heat exchange between the refrigerant and the human tissue outside the electric cold ablation needle, and at least part of the needle rod 102 is provided with an insulation layer 112; the needle tip 101 is electrically and thermally conductive; a liquid inlet pipe 104 for inputting the refrigerant; the area from the outlet of the liquid inlet pipe 104 to the needle point 101 forms an expansion chamber 105 for absorbing heat of the refrigerant by vaporization and exchanging heat with the tissue through the needle point 101; the interlayer between the needle bar 102 and the liquid inlet pipe 104 forms a gas return cavity 106 for returning gasified refrigerant;

in one embodiment, the area of the insulating layer 112 at least completely covers the area of the insulating layer 111.

In operation, the refrigerant is gasified and absorbs heat after the phase change of the expansion chamber 105, the freezing area is defined as the area formed by the needle tip 101 and the non-heat-insulating part of the needle rod 102 is frozen, therefore, when the needle tip 101 is electrified, the area formed by the needle tip 101 and the conductive part of the needle rod 102 is usually completely in the freezing area, so that the insulating layer 112 of the needle rod is at least the same as the area covered by the heat-insulating layer 111 or is larger than the coverage area of the heat-insulating layer 111, of course, the heat-insulating layer 111 cannot prevent the freezing area from being just at the boundary of the heat-insulating layer 111, and normally, the freezing area exceeds the boundary of the heat-insulating layer 111, so that even if the insulating layer 112 and the heat-insulating layer 111 completely coincide, the conductive area can be ensured to be completely in the range of the freezing area.

In a specific embodiment, a sleeve 108 is further provided outside the electric cold ablation needle 10, and the sleeve 108 is sealed and completely and conformally wrapped around the electric cold ablation needle, and comprises a sleeve needle tip 1081 and a sleeve needle rod 1082, wherein the sleeve needle tip 1081 is electrically and thermally conductive, the sleeve needle rod 1082 is insulated, the sleeve 108 completely wraps the electric cold ablation needle 10, and the sleeve 108 is detachably and fixedly connected with the electric cold ablation needle 10.

In another embodiment, the insulating layer 111 and the insulating layer 112 are disposed on a sleeve 108, the sleeve 108 completely and conformably wraps the needle shaft 102 and the needle tip 101 from the outside, the sleeve 108 is electrically and thermally conductive between the needle tip 101 and the external tissue, and the sleeve 108 is detachably and fixedly connected with the needle handle 103.

In another embodiment, the electric cold ablation needle 10 is further provided with a thermocouple 113, and the thermocouple 113 is used for detecting the temperature of the electric cold ablation needle;

in another embodiment, the interior of the needle handle 103 is provided with a heat exchanger 107 for exchanging heat of the inflow liquid and outflow gaseous refrigerants.

In yet another embodiment, the cryoablation needle 10 is a flexible catheter cryoablation needle, the tip of the flexible catheter cryoablation needle is a balloon, and at least one electrode is disposed on the surface of the balloon, and the electrode is electrically connected to the electrotherapy 30 module.

In a first embodiment, as shown in figure 3,

FIG. 3 shows a coat-type electric-cold ablation needle 1 of the utility model, which comprises a needle tip 101, a needle rod 102, a needle handle 103 and a sleeve 108, wherein the needle tip 101 and the needle rod 102 are in an integrated structure, the needle handle 103 is sequentially connected to form an inner ablation needle, the sleeve 108 is divided into a sleeve needle tip 1081 and a sleeve needle rod 1082, the sleeve needle tip 1081 is heat-conducting and electric-conducting, the sleeve needle rod 1082 is heat-insulating and the outer surface is provided with an insulating layer 1083 (all embodiments are in a similar form and refer to FIG. 7), the materials of the needle tip 101 and the needle rod 102 are selected from electric-conducting and heat-conducting materials, and the material of the needle handle 103 is selected from heat-insulating and non-conducting materials; the inside of the needle bar 102 is provided with a liquid inlet pipe 104, and after being led into the liquid inlet pipe 104 through a liquid pipe 204 (refer to fig. 2), the refrigerant is led into the needle tip 101 and the inside of the needle bar 102, and is subjected to phase change heat absorption when passing through the ablation zone 105, is converted into a gas state from a liquid state, is discharged out of the outer sleeve type electric cold ablation needle 1 through the air return cavity 106, and is led into the compression pump 201 through an air pipe 208 for recovery treatment (refer to fig. 2); a needle handle heat exchanger 107 is also provided inside the needle handle 103 for heat exchange of liquid and gaseous refrigerants; because the needle tip 101 and the needle rod 102 are integrally in a conductor structure, the needle tip 101 and the needle rod 102 can be integrally electrified by connecting the first electrode 109 at any position of the ablation needle, and then the sleeve 108 tightly connected with the needle tip 101 and the needle rod 102 is integrally conductive, and because the surface of the sleeve needle rod 1082 is provided with the insulating layer 1083, only the sleeve needle tip 1081 is conductive; one end of the first electrode 109 is electrically connected with the electrical treatment generator, so that under the condition of being used together with the other electrode, the trocar point 1081 can form electrical treatment on the treatment area, and the phase change heat absorption is combined when the refrigerant passes through the ablation area 105, and meanwhile, the trocar point 1081 made of heat conducting materials can be cooled, a cryoablation environment is formed in the nearby area, and the treatment area is frozen; thus, the present embodiment can perform cryoablation and electrical therapy synchronously or asynchronously in the treatment area.

It should be further noted that, since the needle 10 is directly contacted with the human body and needs to conduct cold energy and electric energy, the needle 10 should be made of an electrically and thermally conductive material, and the physical and chemical properties of the material are stable under the condition of low temperature and power, and, in order to facilitate the penetration of the skin surface, it is preferable that the needle is a conductor that does not generate electric corrosion, for example: platinum metal, platinum alloy, graphene, etc., and, in addition, needle 10 is generally sharp in shape.

In one embodiment, the cryoablation needle 1 is a flexible catheter cryoablation needle, the needle of the flexible catheter cryoablation needle is a balloon 100, at least part of the area of the outer surface of the balloon 100 has conductivity for conducting electrical energy for electrical treatment, and the balloon 100 can be filled with refrigerant for conducting cold energy for cryoablation.

It should be further noted that, depending on the location of the lesion, the user may select a rigid cryoablation needle or a flexible cryoablation needle, and in general, the rigid cryoablation needle should be used at a location where the lesion can be directly penetrated, and the flexible cryoablation needle should be used at a lesion location where a lumen is connected.

As shown in figure 4 of the drawings,

in one embodiment, the structure of needle tip 101, needle shaft 102, and needle handle 103 together with the detachable design of cannula 108 may be implemented by a snap fit or any other alternative prior art structure, which may be used in any of the embodiments.

Also, if an inner insulating layer 111 (this part may refer to fig. 9 a) is provided inside the needle bar 102, it is possible to make the needle tip 101 electrically and thermally conductive while electrically and thermally insulating the vicinity of the needle bar 102 by this structural arrangement.

Another sleeve may be used, which is provided with an insulating layer 1083 only at the portion sleeved on the needle bar 102, and does not perform a heat insulation structure (or uses a heat insulation material); the detachable use of the ablation needle with the inner heat insulation layer 111 can still achieve the technical effects of electrically and thermally insulating the vicinity of the needle rod 102 while making the needle tip 101 electrically and thermally conductive.

As shown in figures 5-6 of the drawings,

in one embodiment of FIG. 5a, the air return channel 106 is an air return channel 106-1 directly entering the cryoablation needle 10, and the liquid inlet tube 104-1 and the air return channel 106-1 are arranged in parallel, wherein the orifice of the liquid inlet tube 104-1 is closer to the needle tip 101 than the orifice of the air return channel 106-1, and the diameter of the air return channel 106-1 is larger than the diameter of the liquid inlet tube 104-1.

In one embodiment of FIG. 5b, the inlet 104-2 is disposed inside the return air conduit 106-1.

In one embodiment of FIG. 6a, the orifice of the inlet tube 104-3 is a flared orifice 104-31.

In one embodiment of FIG. 6b, the nozzle of the feed tube 104-4 is provided with a heat exchanger 104-41.

In the second embodiment, as shown in fig. 7-9,

referring to fig. 7, fig. 7 is a view showing a flexible electric cooling duct 1-3 according to the present utility model, which is different from the first embodiment in that the whole structure of the present embodiment is a flexible structure; flexible cannula 1013 is used in place of cannula 108, and flexible needle 1011 and flexible needle shaft 1012 are used in place of needle tip 101 and needle shaft 102; the flexible sleeve 1013 comprises a flexible sleeve needle 10131 with an insulated heat conducting portion and an insulated flexible sleeve needle 10132 instead of the sleeve needle tip 1081 and sleeve needle 1082, and to achieve an electrically conductive function as the needle tip 1081, at least one electrode is provided on the surface of the flexible sleeve needle 10131 for electrotherapy, preferably N electrode rings matched in pairs, for example a first flexible catheter electrode 1018 and a second flexible catheter electrode 1019 appearing in pairs in the figure, which are supplied with electrotherapy energy via different electrode wire connections, respectively.

Referring to fig. 8, fig. 8 is a preferred alternative to the above-described construction of the balloon cryoablation needle 1-4, which compares to the construction of fig. 7, with the balloon needle 1014 being used instead of the flexible needle 1011, the balloon flexible cannula 1017 being used instead of the flexible cannula 1013, further, with the balloon cannula needle 10171 being used instead of the flexible cannula needle 10131, and the balloon cannula needle shaft 10172 being used instead of the flexible needle shaft 1012, the above-described alternative construction being indistinguishable from the corresponding construction of fig. 7 except for the inflation characteristics of the balloon itself, the advantage of using the balloon construction being that the cryoablation needle has a better fit when in use; at least one electrode is arranged on the balloon sleeve needle 1015 for electric treatment, and N electrode plates matched in pairs are preferably arranged, for example, a first balloon sleeve electrode plate 1015 and a second balloon sleeve electrode plate 1016 which are arranged in pairs in the figure; the two are respectively connected through different electrode wires, and form an electric loop after contacting with a human body, and the aim of electric treatment is achieved by connecting an electric treatment generator.

Summarizing the common features of the above embodiments, referring to the figures, fig. 9 shows two different implementations of an electro-cold ablation needle, 9a representing an inner insulated sleeve ablation needle and 9b representing an outer insulated ablation needle; both of the above forms are provided with the insulating layer 1083, and it should be noted that the insulating layer 1083 should cover the surface in direct contact with the human body; the coverage of the insulating layer 1083 is at least not less than that of the insulating layer, whether the inner insulating layer 111 or the trocar 1082 with heat insulation, for ensuring that the electric treatment is generated and frozen in the scope of the frozen part formed by cryoablation; the structure with the external sleeve form has the use advantage in any embodiment, the specific medical equipment needs to be disinfected or consumable replaced after being used, the external sleeve form is adopted to replace/disinfect only the outer tube, the disinfection of a user is facilitated, the maintenance of medical safety is facilitated, one component of the ablation needle can be matched with the component of the ablation needle, reference can be made to fig. 13, the matching of a sterile bag and the ablation needle is shown in fig. 13, the ablation needle penetrates through the whole structure of the sterile bag to cover the whole structure of the electric cold ablation needle, and a part of a catheter connected with the tail of the electric cold ablation needle and an arm or a part of a trunk of a user (doctor) are further covered, so that a sterile area in operation is enlarged.

A closed loop refrigeration module 20 for delivering a refrigerant to the cryoablation needle 10 and controlling the circulation of the refrigerant; comprises a compressor 201 for compressing the gasified gaseous refrigerant; a condenser 202 for liquefying the compressed refrigerant; a liquid tank 203 for separating the gaseous and liquid refrigerants, preventing the compressor from being hit by liquid, and storing the liquid refrigerant, and adjusting the liquid supply amount according to the load variation; a filter 209 for filtering impurities of the refrigerant; a liquid pipe 204, one end of which is connected with the liquid storage tank 203, and the other end of which is connected with the liquid inlet pipe 104, for conveying liquid refrigerant; one end of the air pipe 208 is connected with the air return cavity 106 of the electric cold ablation needle 10, and the other end of the air pipe is connected with the compressor 201 and is used for recovering and conveying gasified refrigerant; it should be noted that the expression "closed-loop refrigeration" in the present utility model specifically refers to an integral closed loop between any refrigeration device, pipe and cryoablation needle involved in the operation of a refrigerant, namely: the portion having the refrigerant involved in circulation is a closed-loop structure, and the concept of closed-loop means that the refrigerant inside the present utility model is not discharged outside the present utility model except for the subjective intention of the user.

In an embodiment, the closed-loop refrigeration module further includes a four-way valve 207, where one end of the four-way valve 207 is connected to the compressor 201, and the other end is connected to the condenser 202, so as to change the flow direction of the refrigerant.

It should be noted that, the four-way valve 207 may implement a refrigeration cycle or a heating cycle by changing the flow direction of the gaseous or liquid refrigerant, and in operation, the refrigeration cycle first freezes the focal region, thereby defining the region for electric treatment, but if the freezing temperature is too low, the freezing region cannot be energized, and thus, the freezing region can be warmed up to a certain extent by changing the flow direction of the refrigerant, and then effective electric treatment is performed, and in general, the freezing region cannot be conducted at a temperature lower than (-21 ℃) and effective electric treatment can be performed as long as the freezing region is at a temperature lower than or equal to (0 ℃).

In one embodiment, the liquid pipe 204 is provided with a liquid inlet valve 205 for controlling the liquid inlet amount of the refrigerant of the cryoablation needle 10 and stopping liquid inlet; the air pipe 208 is provided with an air outlet valve 206 for controlling the air outlet pressure of the gasified refrigerant of the electric cold ablation needle 10 and stopping after the refrigerant is emptied; a liquid outlet is arranged on the liquid storage tank 203 and is used for discharging the refrigerant; the liquid return port is used for returning the liquefied refrigerant; the filling port is used for filling the refrigerant, and the overflow port is used for safely overflowing the refrigerant when the pressure is too high due to too much refrigerant.

Before working, a user fills a certain amount of refrigerant through a filling port of the liquid storage tank 203 so as to ensure the initial starting of the refrigeration process; when the refrigerating device is in operation, when a user sends out a refrigerating request, the liquid outlet is opened, the refrigerant flows out of the liquid storage tank 203 through the liquid pipe 204 and enters the refrigerating cycle process, after one cycle is completed, the gasified refrigerant returns to the liquid state after being compressed, at the moment, the liquid return port is opened, and the circulated liquid refrigerant flows back to the liquid storage tank 203. In addition, loss of refrigerant occurs during circulation of the refrigerant, and when the loss reaches a certain level, the user still needs to supplement the refrigerant by opening the filling port.

It should be noted that the refrigerants selected in the present utility model include, but are not limited to, sulfur hexafluoride, carbon dioxide, nitrous oxide, R133, R134a, and other common refrigerants, and the refrigerants are not limited herein either alone or in combination.

When a user sends out a refrigeration demand, the refrigerant flows out of the liquid storage tank 203, is conveyed to the liquid inlet valve 205 through the liquid pipe 204, enters the liquid inlet pipe 104 through the heat exchanger 107 in the needle handle 103, is gasified rapidly at the expansion chamber 105, and absorbs a large amount of heat, so that the vicinity of the needle 101 is frozen, the gasified refrigerant flows out of the needle handle 103 through the air return cavity 106 under the heat exchanger 107, flows back to the compressor 201 through the air outlet valve 206 after passing through the air pipe 208, the compressor 201 compresses the gaseous refrigerant and conveys the compressed gaseous refrigerant to the condenser 202, the gaseous refrigerant is subjected to phase change liquefaction after condensation, and the liquefied refrigerant flows back through the backflow port of the liquid storage tank 203 after being filtered, so that one cycle is completed. In addition, when the refrigeration demand is over, the liquid inlet valve 205 is closed, stopping the delivery of refrigerant, and at the same time, the vapor outlet valve 206 empties all of the vaporized thickness of the gaseous refrigerant.

An electrical treatment generation module 30 electrically connected to the needle tip 101 of the electrical cold ablation needle 10 for delivering electrical treatment energy to the electrical cold ablation needle 10.

In a specific embodiment, the electrical therapy generation module comprises at least an electrochemical generator and/or an electrochemical therapy generator and/or an electrical pulse generator.

In a specific embodiment, the electric treatment device based on closed-loop refrigeration further comprises an electric heater, wherein the electric heater is connected with the electric cold ablation needle and used for heating and rewarming the electric cold ablation needle.

In operation, the electrical treatment generating module 30 continuously outputs a constant current to the electrical cold ablation needle 10 to perform electrical treatment, namely, the tissue in the target area defined by the frozen puck can be subjected to electrical treatment, and when the output electrical energy is accumulated for a period of time, a certain coulomb quantity is output in the target area, so that the electrical treatment of the focus of the target area is realized. However, due to the temperature limitation of the freezing on the electric cold ablation needle 10, a passage cannot be formed between the electric cold ablation needles 10, and the electric energy cannot be output at the focus position of the target area, so that the effective electric treatment cannot be realized, so that when the electric cold ablation needle 10 needs to be rewarmed, the four-way valve 207 is opened, the flow direction of the refrigerant is changed, the electric cold ablation needle 10 is heated, and an effective electric passage is formed, and generally, the situation occurs when the freezing temperature is lower than-21 ℃, therefore, in order to realize the electric treatment process, the temperature of the frozen ice ball must be increased, so that the conduction of the electric energy can be realized by the frozen ice ball, and generally, the effective electric killing ablation can be realized as long as the temperature of the frozen ice ball is lower than the freezing point (0 ℃).

In one embodiment, the user cannot use two or more cryoablation needles 10 at the same time according to the lesion treatment requirement of the patient, and only one cryoablation needle 10 is used, and an electrode is arranged outside the patient, so that an ablation circuit forms a loop.

The utility model realizes cryoablation by using a refrigerant closed cycle refrigeration mode; an electric cooling combined treatment mode is realized by combining the electric treatment mode; solves the problems of refrigerant acquisition, transportation, storage, use and leakage, greatly facilitates the application of freezing and electric cold treatment technology, ensures personnel safety, avoids environmental pollution, saves cost and is environment-friendly.

As shown in figures 10-15 of the drawings,

the utility model also discloses an electric treatment method based on cold circulation, which comprises the following specific steps:

step S1: the refrigerant is conducted to the electric cooling ablation needle and cold energy is released, so that a target area of the electric cooling ablation needle is frozen;

in a specific embodiment, the method further includes the following steps before step S1:

step S11: the needle tip of the electric cooling ablation needle pierces a sterile bag, so that the sterile bag passes through the needle rod and is sleeved on the needle handle;

step S12: the cannula is attached to the cryoablation needle and the sterile pouch is clamped at the connection.

In one embodiment, the cooling energy releasing process of the refrigerant in step S1 includes the following steps:

step a1: delivering liquid refrigerant to an expansion chamber area of the electric cooling ablation needle;

step a2: the refrigerant is gasified and absorbed in the expansion chamber of the electric cooling ablation needle rapidly, so that the target area of the electric cooling ablation needle is frozen to form ice.

Step S2: outputting electric energy to a target area through electric cold ablation, and carrying out electric treatment on the target area;

in one embodiment, as shown in fig. 12, after the completion of the electrical treatment, the cryoablation needle is withdrawn from the focal region further comprising the steps of:

step S21, intermittently extracting the electric cold ablation needle from the focus area, and intermittently electrifying the electric cold ablation needle until the electric cold ablation needle is completely extracted from human tissues;

in the working process, after the electric treatment of the focus area is finished, the electric cold ablation needle needs to be pulled away from the focus area, so that the problems of infection of other tissues caused by pollution of the electric cold ablation needle in the focus area, bleeding of the focus area in the pulling-away process of the electric cold ablation needle and the like are solved by an electrifying mode, and the problem is solved by an intermittent electrifying mode in order to prevent damage to other tissues of a patient caused by continuous electrifying.

In a specific embodiment, the replacement process of the cryoablation needle after the completion of the electrical treatment comprises the following steps:

step b1, closing a liquid inlet valve, and stopping delivering liquid refrigerant to the electric cold ablation needle;

step b2, evacuating gasified refrigerant in the electric cold ablation needle, and closing the air outlet valve;

and b3, detaching the sleeve of the electric cold ablation needle so as to replace or prepare for replacing a new electric cold ablation needle sleeve.

The above embodiments are merely illustrative of the principles of the present utility model and its effectiveness, and are not intended to limit the utility model. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the utility model. Accordingly, it is intended that all equivalent modifications and variations of the utility model be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims (10)

1. An electrotherapy device based on closed loop freezing comprising at least one interface, comprising:

the electric cold ablation needle comprises a needle handle and a needle rod, the needle handle is connected with the needle rod, and a heat exchanger is arranged in the needle handle and used for heat exchange of flowing-in liquid and flowing-out gaseous refrigerants; a needle tip that is electrically and thermally conductive; the sleeve is provided with a heat insulation layer and an insulation layer, the sleeve completely and conformably wraps the needle rod and the needle point from the outside, the sleeve conducts electricity and heat between the needle point and external tissues, and the sleeve is detachably and fixedly connected with the needle handle;

a liquid inlet pipe for inputting or outputting liquid refrigerant from or to the electric cold ablation needle by the closed-loop frozen electric treatment device; an expansion chamber is formed from the outlet of the liquid inlet pipe to the inside of the needle point and is used for vaporizing and absorbing heat of the refrigerant and performing heat exchange with tissues through the needle point; the interlayer of the needle bar and the liquid inlet pipe forms an air return cavity for returning gasified refrigerant into the device;

the closed-loop refrigeration module comprises a compressor and is used for compressing gasified refrigerant; a condenser for liquefying the compressed refrigerant; a liquid storage tank for separating the gaseous and liquid refrigerants, preventing the compressor from being hit by liquid, and storing the liquid refrigerant, and adjusting the liquid supply amount according to the load change; a filter for filtering impurities of the refrigerant; one end of the liquid pipe is connected with the liquid storage tank, and the other end of the liquid pipe is connected with the liquid inlet pipe and is used for conveying liquid refrigerant; one end of the air pipe is connected with the air return cavity of the electric cooling ablation needle, and the other end of the air pipe is connected with the compressor and is used for recovering and conveying gasified refrigerant; the closed-loop refrigeration module comprises a four-way valve, and the four-way valve can reverse the flow direction of gaseous refrigerant compressed by the compressor, so that the refrigerant is condensed in the needle point expansion chamber to generate heat;

and the electric treatment module is electrically connected with the needle point and is used for delivering electric treatment energy to the electric cold ablation needle.

2. An electrotherapy device based on closed loop freezing according to claim 1, wherein the insulating layer region of said sleeve at least completely covers the region of the insulating layer of said sleeve.

3. The closed-loop cryogenically-based electrotherapy device of claim 1 wherein the cryogenically-ablative needle further comprises an air return tube for gaseous cryogen to be input to or output from the closed-loop cryogenically-effective electrotherapy device.

4. An electrotherapy device based on closed-loop refrigeration according to claim 1, wherein the outlet of said feed tube adjacent to said needle tip is provided with an expansion port; and a heat exchanger is arranged at the part of the liquid inlet pipe, which is close to the needle point.

5. An electrotherapy device according to claim 1, wherein the portion of said feed tube adjacent said tip is provided with a heat exchanger.

6. An electrotherapy device according to any one of claims 1 to 5, wherein said cryoablation needle is a flexible catheter and/or balloon having at least one electrode disposed on its surface, said electrode being electrically connected to said electrotherapy module.

7. An electro-therapeutic device as claimed in any one of claims 1 to 5, wherein said needle is further provided with a thermocouple for detecting the temperature of the needle.

8. An electrotherapy device according to any one of claims 1 to 5, wherein said fluid tube is provided with a fluid inlet valve for controlling the volume of refrigerant inlet to said cryoablation needle and for disabling the inlet; and the air pipe is provided with an air outlet valve for controlling the air outlet pressure of the gasified refrigerant of the electric cooling ablation needle and stopping after the refrigerant is emptied.

9. An electrotherapy device according to any one of claims 1 to 5, wherein said fluid reservoir has a fluid outlet for the outflow of said cryogen; the liquid return port is used for returning the liquefied refrigerant; a filling port for replenishing the refrigerant; and an overflow port for safely overflowing the refrigerant when the pressure is too high due to too much refrigerant.

10. An electrotherapy device based on closed loop freezing according to any one of claims 1 to 5, wherein said electrotherapy generation module comprises at least an electrochemical generator, and/or an electrotherapy generator, and/or an electrical pulse generator.