CN115804637A - Vein radio frequency ablation system and processing method - Google Patents

Abstract

The invention discloses a vein radiofrequency ablation system and a processing method, wherein the vein radiofrequency ablation system comprises: the pushing rod is a hollow pipe fitting, a threading channel is arranged in the pushing rod, and the two axial ends of the pushing rod are a far end and a near end which are opposite; the handle is fixedly connected to the near end of the pushing rod; a heating element located at a distal end of the push rod, the heating element being a heater wire that employs a conductive memory material and is helically wound into a primary spring having: a pre-set state, wherein the primary spring is integrally spirally wound to form a secondary spring; in a stretching state, the secondary spring is relatively straightened. The utility model provides a pipe diameter is less than prior art's pipe diameter, can put into in the less blood vessel, can make its release after can closely laminate with the vascular wall according to the size of the selection heating element of the diameter adaptability of blood vessel in addition, adopts lower temperature can treat varicosity, reduced the risk that the blood vessel burnt.

Description

Venous radiofrequency ablation system and processing method

technical field

The present application relates to the technical field of medical devices, in particular to a vein radiofrequency ablation system and a processing method.

Background technique

Varicose veins is a common disease, which is a common disease of the venous system. The main reason is that the congenital vascular wall is relatively weak or the same posture is maintained for a long time. This causes blood vessels to protrude from the surface of the skin.

Surgery for varicose veins includes traditional high ligation and stripping of the great saphenous vein, laser therapy, radiofrequency ablation, microwave therapy, electrocoagulation therapy, and translucent atherectomy. These surgeries have their own advantages and disadvantages. On the whole, radiofrequency ablation is the best treatment. During radiofrequency ablation, a radiofrequency catheter is punctured into the great saphenous vein through the vicinity of the knee joint, and radiofrequency energy is released through the catheter. The venous blood vessels are damaged by the high temperature generated by heat energy, causing vascular contracture, which thickens the vein wall, shrinks the lumen, and forms fibrosis. , which eventually closes the walls of the veins, thereby solving the problem of varicose veins.

Currently, the common radiofrequency ablation products on the market use a dedicated electrode catheter in combination with a radio frequency generator to generate heat energy at the heating element at the distal end of the electrode catheter to treat varicose veins. However, the diameters of the electrode catheters are both 6F and 7F, so the diameter of the invading blood vessel is large and cannot be in close contact with the blood vessel wall. In addition, the temperature of the electrode catheter is relatively high, and there is a problem of burning the blood vessel.

Contents of the invention

The invention provides a venous radiofrequency ablation system and a processing method, which solve the problems of larger diameters of invading blood vessels and burning blood vessels in the prior art.

Venous radiofrequency ablation system, including:

A push rod, the push rod is a hollow pipe, the inside of which is a passageway, and the axial ends of the push rod are opposite distal ends and proximal ends;

a handle fixedly connected to the proximal end of the push rod;

The heating element is located at the far end of the push rod, the heating element is a heating wire, the heating wire is made of conductive memory material and is spirally wound into a primary spring, and the primary spring has:

In the predetermined state, the primary spring is helically wound as a whole to form a secondary spring;

In a stretched state, the secondary spring is relatively straightened;

A catheter with a catheter hub at the distal end, through which the heating element penetrates into the interior of the catheter in a stretched state.

The following also provides several optional ways, but they are not used as additional limitations on the above-mentioned overall scheme, but are only further additions or optimizations. On the premise of no technical or logical contradiction, each optional way can be carried out independently for the above-mentioned overall scheme Combination can also be a combination of multiple options.

Optionally, the interior of the primary spring is a first cavity, and a thermocouple is fixed in the first cavity, and the thermocouple is connected to a first wire, and the first wire passes through the first cavity in turn. and the push rod extends proximally inwardly to the handle.

Optionally, there is an axial distance of 6-20 mm between the distal end of the thermocouple and the distal end of the primary spring.

Optionally, the proximal end of the primary spring is inserted into and fixed in the push rod, the heating wire is connected with a second wire, and the second wire extends inwardly to the handle via the push rod.

Optionally, the proximal end of the handle also has a circuit connector, the first wire and the second wire are connected to the circuit connector, and the handle is equipped with a An on-off switch of the second wire.

Optionally, at the proximal end of the primary spring, the heating wire has two straight sections, wherein one straight section is straightened at the proximal end of the primary spring, and the other straight section is straightened at the distal end of the primary spring. The first lumen turns back and extends out of the first lumen;

There are two second wires, which are respectively welded to the corresponding straight sections, and the welding points are arranged in dislocation.

Optionally, the outer surface of the heating wire has an insulating layer.

Optionally, the diameter of the heating wire is 0.1-0.2 mm, and the diameter of the primary spring is 0.6-1.0 mm.

Optionally, the diameter of the secondary spring is 2-20 mm, and the length of the secondary spring is 3-20 cm.

The present invention also provides a processing method of the vein radiofrequency ablation system as described above, including:

Step S100, providing a conductive heating wire, the diameter of the heating wire is 0.1-0.2 mm;

Step S200, the primary spring is obtained after the heating wire is spirally wound and heat-treated to shape, and the diameter of the primary spring is 0.6-1.0 mm;

Step S300, the secondary spring is obtained after the primary spring is helically wound and heat-treated as a whole, the diameter of the secondary spring is 2-20 mm, and the length of the secondary spring is 3-20 cm;

Step S400, installing a push rod with a handle on one end of the secondary spring;

Step S500, stretching the secondary spring and threading it into a catheter with a catheter adapter to obtain the vein radiofrequency ablation system.

The application at least has the following technical effects:

1. The diameter of the catheter is smaller than that of the prior art, and can be placed in smaller blood vessels.

2. There are multiple options for the diameter and length of the secondary spring, and the size of the heating element can be adaptively selected according to the diameter of the blood vessel, so that it can be closely attached to the blood vessel wall after release, and varicose veins can be treated at a lower temperature. Reduced risk of vascular burns.

Description of drawings

FIG. 1 is a schematic diagram of the structure of an embodiment of an intravenous radiofrequency ablation system provided by the present application without a catheter;

Fig. 2 is the structural schematic diagram that the thermocouple of the present application extends into the heating element in tension state;

Fig. 3 is a structural schematic diagram of the heating element in Fig. 1 being in a preformed state;

Fig. 4 is a structural schematic diagram of the fixed connection between the heating element and the push rod;

Fig. 5 is the structural representation of circuit board;

Fig. 6 is a structural schematic diagram of the vein radiofrequency ablation system;

Fig. 7 is a structural schematic view of the cooperation of the catheter and the catheter adapter;

Fig. 8 is a flow chart of the processing method of the vein radiofrequency ablation system.

The reference signs in the figure are explained as follows:

100, push rod; 110, threading channel;

200, handle; 210, circuit connector; 211, circuit board; 212, electronic components; 220, switch;

300, heating wire; 310, primary spring; 311, first cavity; 312, thermocouple; 313, first wire; 314, second wire; 315, solder joint; 320, secondary spring; 321, ball head; 330, straight section; 331, straight section;

400. Catheter; 401. Catheter seat; 402. Guiding part.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the drawings in the embodiments of the application. Apparently, the described embodiments are only some, not all, embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

It should be noted that when a component is said to be "connected" to another component, it may be directly connected to the other component or intervening components may also exist. When a component is said to be "set on" another component, it may be set directly on the other component or there may be an intervening component at the same time.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs. The terms used herein in the description of the application are only for the purpose of describing specific embodiments, and are not intended to limit the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the present application, the terms "first", "second" and so on are only used for descriptive purposes, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity and order of the indicated technical features. Thus, a feature defined as "first" and "second" may explicitly or implicitly include one or more of these features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

Referring to FIGS. 1 to 7 , an embodiment of the present application provides a radiofrequency ablation system for veins, including a push rod 100 , a handle 200 , a heating element and a catheter 400 .

For ease of understanding, the distal end and the proximal end in the following examples are determined by the distance from the operator. For details, refer to X and Y in Figures 1 to 3. Specifically, X is the proximal end, and Y is the distal end. .

Referring to Figures 1 to 5, the push rod 100 is a hollow pipe with a through channel 110 inside, and the two axial ends of the push rod 100 are opposite distal and proximal ends, and the specific material can be stainless steel, nickel titanium, PEEK, PI , PA, etc. The handle 200 is used to manipulate the push rod 100 and is fixedly connected to the proximal end of the push rod 100 . The heating element is located at the far end of the push rod 100. Specifically, the heating element is a heating wire 300, and the heating wire 300 is made of a conductive memory material, such as a nickel-iron alloy wire, a stainless steel wire, or a nickel-titanium alloy wire. The heating wire 300 is helically wound to form a primary spring 310 .

The primary spring 310 has two opposing states, including:

In the predetermined state shown in FIG. 3 , the primary spring 310 is spirally wound as a secondary spring 320 as a whole;

In the stretched state shown in FIG. 2 , the secondary spring 320 is relatively straightened in the stretched state.

The pre-setting state can be achieved through heat treatment. Specifically, the primary spring 310 is wound on the secondary forming mandrel and arranged closely, and placed in a heat setting furnace for setting for 10-20 minutes at a setting temperature of 400-800°C. After the setting is completed In order to avoid the problem that the distal part of the secondary spring 320 will scratch the blood vessel wall when it is placed in the blood vessel, the distal end of the secondary spring 320 is treated with a ball head 321. The ball head 321 can be treated with technology, and UV glue can be selected for curing. Forming or laser welding machine forming.

Referring to FIGS. 6-7 , the catheter 400 has a diameter of 4F and has a catheter seat 401 at one end, and the heating element penetrates into the interior of the catheter 400 through the catheter seat 401 in a stretched state.

The inner diameter of the catheter base 401 is larger than the diameter of the catheter 400. In order to facilitate the penetration of the heating element, a guide part 402 with a gradually decreasing inner diameter is provided on the side close to the catheter 400, so that the heating element can smoothly penetrate into the catheter 400 from the larger inner diameter part. Inside.

The heating element of the venous radiofrequency ablation system of this application adopts memory materials, and has two states: pre-shaped and stretched. When released in the blood vessel, the heating element is converted from the stretched state to the pre-shaped state, so that the heating element can closely fit the blood vessel. wall.

Specifically, the heating element in the stretched state is first inserted into the catheter 400 from the catheter adapter 401. When the heating element needs to be released, the catheter 400 moves to the proximal end relative to the heating element. At this time, the heating element starts from the distal end and moves toward the proximal The end is released sequentially (at this time it is in a predetermined state) and closely adheres to the blood vessel wall. Of course, the contact area between the heating element and the blood vessel wall can be controlled by the operator according to actual needs. The element moves proximally, at this time, the heating element in the catheter 400 passes through the catheter 400 and is released, which increases the contact area with the blood vessel wall. Similarly, when the contact area needs to be reduced, the catheter 400 is placed relative to the heating element Moving to the distal end, at this time, part of the heating element released in the blood vessel returns to the catheter 400, that is, the contact area with the blood vessel wall is reduced.

The inside of the primary spring 310 is the first cavity 311, and a thermocouple 312 is fixed in the first cavity 311 (it can be directly fixed by glue). The thermocouple 312 can accurately detect the temperature of the heating element, allowing the operator to precisely control The temperature range of the heating element is to avoid burning blood vessels if the temperature is too high, and the temperature is too low to achieve the closing effect of the vein wall. The specific material of the thermocouple 312 is not limited, and nickel-chromium, nickel-aluminum alloy wire and other materials can be used. The thermocouple 312 is connected with a first wire 313 , and the first wire 313 extends to the handle 200 through the first lumen 311 and the push rod 100 to the proximal end.

The manner in which the first wire 313 is arranged in the first cavity 311 avoids the problems of interference and entanglement with the exterior of the primary spring 310 , and enables the primary spring 310 to smoothly change from a stretched state to a predetermined state.

The thermocouple 312 can be fixed anywhere in the first cavity 311 , and there is an axial distance of 6-20 mm between the distal end of the thermocouple 312 and the distal end of the primary spring 310 . Preferably, the axial distance between the two is 10mm.

Optionally, there can be one or more thermocouples.

The proximal end of the primary spring 310 is inserted into and fixed in the push rod 100 , the heating wire 300 is connected with a second wire 314 , and the second wire 314 extends inward and proximally to the handle 200 through the push rod 100 .

The proximal end of the primary spring 310 specifically refers to the proximal end in a stretched state. As shown in FIG. The wires 313 are all inside the passing channel 110 . When fixing, first smear UV glue on the outer periphery of the primary spring 310 extending into the push rod 100, and then bond it to the inner wall of the push rod 100. The length is greater than 5mm.

The proximal end of the handle 200 also has a circuit connector 210 for connecting to an external circuit. Both the first wire 313 and the second wire 314 are connected to the circuit connector 210. The connection method can be direct or indirect connection, in this embodiment, it is an indirect Connection, both the first wire 313 and the second wire 314 are connected to the circuit connector 210 through the handle 200 .

In order to reduce the interference to the state change of the primary spring 310, at the proximal end of the primary spring 310, the heating wire 300 has two straight sections, wherein the straight section 330 is straightened by the proximal end of the primary spring 310, and the other straight section 331 is the primary spring 310. The distal end of the first lumen 311 turns back and extends out of the first lumen 311;

There are two second wires 314, which are respectively welded to corresponding straight sections, and the welding spots 315 are arranged in dislocation.

The dislocation arrangement of the two solder joints 315 can prevent the risk of short circuit caused by the two solder joints being too close together. Furthermore, UV glue can be coated on the welded solder joints 315 for insulation.

The handle 200 includes a drive board for driving the radiofrequency vein ablation system. As shown in FIG. , one of which is used to connect to the positive pole, and the other is used to connect to the negative pole. The two second wires 314 have no requirements for positive and negative poles. Optionally choose one connection), for welding the first wire 313 connected to the positive pole with the RD position, and welding the first wire 313 connected to the negative pole with YE.

In order to start and stop heating, the handle 200 is equipped with a switch 220 connected to the second wire 314 to control the on-off of the second wire 314 . As long as the switch 220 is operated, the heating element can be controlled to start or stop heating accordingly.

Considering safety issues, the outer surface of the heating wire 300 has an insulating layer. Of course, in order to strengthen the insulation effect, the heating wire 300 can also be inserted into an insulating heat-shrinkable tube for double insulation protection.

In this embodiment, the diameter of the heating wire 300 is 0.1-0.2 mm, preferably, the diameter of the heating wire 300 is 0.12 mm. The diameter of the primary spring 310 is 0.6-1.0mm, preferably, the diameter of the primary spring 310 is 0.7mm.

The diameter of the secondary spring 320 is 2-20mm, preferably, the diameter of the secondary spring 320 is 4mm.

The length of the secondary spring 320 is 3-20 cm, preferably, the length of the secondary spring 320 is 3 cm, 5 cm and 10 cm.

The vein radiofrequency ablation system of this application has the following technical effects:

1. The diameter of the catheter is 4F, which is smaller than that of 6F and 7F catheters in the prior art, and can be placed in smaller blood vessels.

2. There are multiple options for the diameter and length of the secondary spring, and the size of the heating element can be adaptively selected according to the diameter of the blood vessel, so that it can be closely attached to the blood vessel wall after release, and varicose veins can be treated at a lower temperature. Reduced risk of vascular burns.

The present invention also provides a processing method using the vein radiofrequency ablation system described above, as shown in Figure 8, including:

Step S100, providing a conductive heating wire 300, the diameter of the heating wire 300 is 0.1-0.2 mm;

Step S200, the primary spring 310 is obtained after the heating wire 300 is spirally wound and heat-treated to shape, and the diameter of the primary spring 310 is 0.6-1.0 mm;

Step S300, the secondary spring 320 is obtained after the primary spring 310 is helically wound and heat-treated as a whole, the diameter of the secondary spring 320 is 2-20 mm, and the length of the secondary spring 320 is 3-20 cm;

Step S400, installing the push rod 100 with the handle 200 on one end of the secondary spring 320;

Step S500 , stretching the secondary spring 320 and inserting it into the catheter 400 with the catheter adapter 401 to obtain the above-mentioned vein radiofrequency ablation system.

The technical features of the above-mentioned embodiments can be combined arbitrarily. For the sake of concise description, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification. When the technical features in different embodiments are embodied in the same drawing, it can be considered that the drawing also discloses the combination examples of the various embodiments involved.

The above-mentioned embodiments only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application.

Claims (10)

1. The vein radiofrequency ablation system is characterized in that, comprising: A push rod, the push rod is a hollow pipe, the inside of which is a passageway, and the axial ends of the push rod are opposite distal ends and proximal ends; a handle fixedly connected to the proximal end of the push rod; The heating element is located at the far end of the push rod, the heating element is a heating wire, the heating wire is made of conductive memory material and is spirally wound into a primary spring, and the primary spring has: In the predetermined state, the primary spring is helically wound as a whole to form a secondary spring; In a stretched state, the secondary spring is relatively straightened; A catheter with a catheter hub at the distal end, through which the heating element penetrates into the interior of the catheter in a stretched state. 2. The venous radiofrequency ablation system according to claim 1, wherein the interior of the primary spring is a first cavity, and a thermocouple is fixed in the first cavity, and the thermocouple is connected with a first A guide wire, the first guide wire extends inwardly and proximally to the handle through the first lumen and the push rod in turn. 3 . The vein radiofrequency ablation system according to claim 2 , wherein an axial distance of 6-20 mm is left between the distal end of the thermocouple and the distal end of the primary spring. 4 . 4. The venous radiofrequency ablation system according to claim 2, wherein the proximal end of the primary spring is inserted into and fixed in the push rod, the heating wire is connected with a second wire, and the second wire passes through The push rod extends proximally inwardly to the handle. 5. The vein radiofrequency ablation system according to claim 4, characterized in that, the proximal end of the handle also has a circuit connector, the first wire and the second wire are connected to the circuit connector, the The handle is equipped with a switch connected to the second wire to control the on-off of the second wire. 6. The vein radiofrequency ablation system according to claim 4, wherein at the proximal end of the primary spring, the heating wire has two straight sections, wherein the straight section is straightened at the proximal end of the primary spring , the other straight section is the part where the distal end of the primary spring turns back through the first lumen and extends out of the first lumen; There are two second wires, which are respectively welded to the corresponding straight sections, and the welding points are arranged in dislocation. 7. The radiofrequency ablation system for veins according to claim 1, wherein the outer surface of the heating wire has an insulating layer. 8 . The radiofrequency ablation system for veins according to claim 1 , wherein the diameter of the heating wire is 0.1-0.2 mm, and the diameter of the primary spring is 0.6-1.0 mm. 9. The vein radiofrequency ablation system according to claim 1, wherein the diameter of the secondary spring is 2-20mm, and the length of the secondary spring is 3-20cm. 10. The processing method of the vein radiofrequency ablation system according to any one of claims 1 to 9, characterized in that it comprises: Step S100, providing a conductive heating wire, the diameter of the heating wire is 0.1-0.2 mm; Step S200, the primary spring is obtained after the heating wire is spirally wound and heat-treated to shape, and the diameter of the primary spring is 0.6-1.0 mm; Step S300, the secondary spring is obtained after the primary spring is helically wound and heat-treated as a whole, the diameter of the secondary spring is 2-20 mm, and the length of the secondary spring is 3-20 cm; Step S400, installing a push rod with a handle on one end of the secondary spring; Step S500, stretching the secondary spring and threading it into a catheter with a catheter adapter to obtain the vein radiofrequency ablation system.

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