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

Vein radio frequency ablation system and processing method

Technical Field

The application relates to the technical field of medical instruments, in particular to a vein radio frequency ablation system and a processing method.

Background

Varicose veins are a common disease, and are a common disease of the venous system, and the main reason is that congenital blood vessel wall membranes are weak or maintain the same posture for a long time, blood accumulates in the lower limbs, and the venous valves are damaged in the morning and the evening to generate overhigh venous pressure, so that blood vessels protrude out of the surface of the skin.

The operation for treating varicosity comprises traditional great saphenous vein high ligation and exfoliation, laser treatment, radio frequency ablation, microwave treatment, electrocoagulation treatment and light transmission rotary cutting. Each of these procedures has advantages and disadvantages, and in combination, treatment with radiofrequency ablation is optimal. During radio frequency ablation treatment, a radio frequency catheter is punctured near a knee joint to intervene in a great saphenous vein, radio frequency energy is released through the catheter, and a vein vessel is damaged by high temperature generated by heat energy to cause vessel contracture, so that the vein wall is thickened, a lumen is contracted to form fibrosis, and finally the vein wall is closed, thereby solving the problem of varicosity.

The products used in the existing common radio frequency ablation in the market are all combined by a special electrode catheter and a radio frequency generator, and heat energy is generated at a heating element at the far end of the electrode catheter, so that varicose veins are treated. However, since the electrode catheters have diameters of 6F and 7F, the diameter of the electrode catheter which has entered the blood vessel is large and cannot be brought into close contact with the blood vessel wall, and the temperature of the electrode catheter is high, which causes a problem of burning the blood vessel.

Disclosure of Invention

The invention provides a vein radiofrequency ablation system and a processing method, which solve the problems of large diameter of an invasive blood vessel and blood vessel burning in the prior art.

A venous radio frequency ablation system comprising:

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 heating wire, the heating wire being a conductive memory material and being helically wound into a primary spring, the 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 springs are relatively straightened;

a catheter having a catheter hub at a distal end thereof, the heating element penetrating into the interior of the catheter via the catheter hub in a stretched state.

Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative may be combined individually for the above general solution or between several alternatives without technical or logical contradictions.

Optionally, a first cavity is formed inside the primary spring, a thermocouple is fixed in the first cavity, the thermocouple is connected with a first lead, and the first lead sequentially extends to the handle through the first cavity and the pushing rod from the inner end to the proximal end.

Optionally, an axial distance of 6 to 20mm is left between the distal end tip of the thermocouple and the distal end tip of the primary spring.

Optionally, the proximal end of the primary spring is inserted into and fixed in the pushing rod, and the heating wire is connected with a second wire extending to the handle through the pushing rod to the proximal end.

Optionally, the proximal end of the handle is further provided with a circuit connector, the first lead and the second lead are both connected to the circuit connector, and the handle is provided with a switch which is connected with the second lead and controls the on-off of the second lead.

Optionally, at the proximal end of the primary spring, the heating wire has two straight sections, one of the straight sections is straightening of the proximal end of the primary spring, and the other straight section is a part where the distal end of the primary spring is folded back through the first channel and extends out of the first channel;

the two second wires are respectively welded and cut to the corresponding straight sections, and welding spots are arranged in a staggered mode.

Optionally, the outer surface of the heating wire is provided with 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 invention also provides a method for processing the vein radiofrequency ablation system, which comprises the following steps:

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

s200, spirally winding and heat-treating and shaping the heating wire to obtain a primary spring, wherein the diameter of the primary spring is 0.6-1.0 mm;

s300, spirally winding and heat-treating the primary spring integrally to obtain a secondary spring, wherein 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 to one end of the secondary spring;

and S500, stretching the secondary spring and then penetrating the secondary spring into a catheter with a catheter seat to obtain the venous radio frequency ablation system.

The application has at least the following technical effects:

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

2. The diameter and the length of the secondary spring are selected in multiple ways, the size of the heating element can be selected according to the diameter adaptability of the blood vessel, the heating element can be tightly attached to the blood vessel wall after being released, varicose veins can be treated by adopting lower temperature, and the risk of vessel burn is reduced.

Drawings

FIG. 1 is a schematic catheter-less configuration of a venous radio frequency ablation system according to an embodiment of the present disclosure;

FIG. 2 is a schematic view of a thermocouple of the present application extending into a heating element in a stretched state;

FIG. 3 is a schematic view of the heating element of FIG. 1 in a pre-set state;

FIG. 4 is a schematic view of the heating element fixedly connected to the pushing rod;

FIG. 5 is a schematic diagram of a circuit board;

FIG. 6 is a schematic structural diagram of a venous radio frequency ablation system;

FIG. 7 is a schematic view of the catheter mated with the catheter hub;

fig. 8 is a flow chart of a method of manufacturing a venous radio frequency ablation system.

The reference numerals in the figures are illustrated as follows:

100. a push rod; 110. a threading channel;

200. a handle; 210. a circuit connector; 211. a circuit board; 212. an electronic component; 220. a switch;

300. a heating wire; 310. a primary spring; 311. a first channel; 312. a thermocouple; 313. a first conductive line; 314. a second conductive line; 315. welding points; 320. a secondary spring; 321. a ball head; 330. a straight section; 331. a straight section;

400. a conduit; 401. a catheter hub; 402. a guide portion.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.

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

In this application, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implying any particular order or number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

Referring to fig. 1-7, an embodiment of the present application provides a venous rf ablation system 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 embodiments are distances relative to an operator, and reference may be made specifically to X and Y in fig. 1 to 3, specifically, X is the proximal end and Y is the distal end.

Referring to fig. 1 to 5, the push rod 100 is a hollow tube, the inside of the push rod is a threading channel 110, two axial ends of the push rod 100 are a distal end and a proximal end which are opposite to each other, 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 distal end of the pushing rod 100, and 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 spirally wound as a primary spring 310.

The primary spring 310 has two opposite states, including:

in the pre-set state shown in fig. 3, the primary spring 310 is generally coiled into the secondary spring 320;

as shown in fig. 2, in an extended state, the secondary spring 320 is relatively straightened in the extended state.

The presetting state can be realized through heat treatment, specifically, the primary spring 310 is wound on a secondary forming mandrel and is tightly arranged, and is placed into a heat setting furnace for setting for 10-20 min, the setting temperature is 400-800 ℃, and after the setting is finished, in order to avoid the problem that the far end part of the secondary spring 320 scratches the vascular wall when the secondary spring is placed into a blood vessel, the far end of the secondary spring 320 is processed by a ball head 321, the ball head 321 can be processed by adopting a technology, and UV glue curing forming or laser welding machine forming can be selected.

Referring to fig. 6-7, a catheter 400 has a diameter of 4F with a catheter hub 401 at one end, and a heating element is threaded into the catheter 400 through the catheter hub 401 in a stretched state.

The inner diameter of the catheter hub 401 is larger than that of the catheter 400, and in order to facilitate penetration of the heating element, a guide portion 402 having a gradually decreasing inner diameter is provided near one side of the catheter 400, so that the heating element can be smoothly passed into the catheter 400 from a portion having a larger inner diameter.

The heating element of this application vein radio frequency ablation system adopts memory material, and has the presetting and tensile two kinds of states, and when releasing in the blood vessel, the heating element converts the presetting state into from tensile state for the heating element can closely laminate the vascular wall.

Specifically, the heating element in a stretched state penetrates into the catheter 400 from the catheter holder 401, when the heating element needs to be released, the catheter 400 moves towards the proximal end relative to the heating element, at the moment, the heating element is sequentially released (in a preset state at the moment) from the distal end to the proximal end to be tightly attached to the blood vessel wall, of course, the contact area of the heating element and the blood vessel wall can be controlled by an operator according to actual requirements, when the contact area needs to be increased, the catheter 400 moves towards the proximal end relative to the heating element, at the moment, the heating element in the catheter 400 penetrates out of the catheter 400 and is released, namely, the contact area with the blood vessel wall is increased, the same is realized, when the contact area needs to be reduced, the catheter 400 moves towards the distal end relative to the heating element, at the moment, the heating element released in the blood vessel partially returns into the catheter 400, namely, the contact area with the blood vessel wall is reduced.

The first cavity 311 is formed inside the primary spring 310, and a thermocouple 312 (which can be directly fixed by gluing) is fixed in the first cavity 311, and the thermocouple 312 can accurately detect the temperature of the heating element, so that an operator can accurately control the temperature range of the heating element, and avoid the phenomena that the blood vessel is burned due to overhigh temperature and the vein wall is not closed due to overlow temperature. The specific material of the thermocouple 312 is not limited, and nickel-chromium, nickel-aluminum alloy wire and other materials can be used. A first wire 313 is connected to thermocouple 312, and first wire 313 extends proximally into handle 200 through first lumen 311 and push rod 100.

The first conducting wire 313 is disposed in the first channel 311, so as to avoid the interference and winding problem with the outside of the primary spring 310, and the primary spring 310 can be smoothly changed from the stretching state to the presetting state.

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

Alternatively, there may be 1 or more thermocouples.

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

The proximal end of the primary spring 310 is specifically referred to as the proximal end in the stretched state, as shown in fig. 4, the proximal end of the primary spring 310 in the stretched state extends into the pushing rod 100, and the second wire 314 and the first wire 313 are both in the threading channel 110. When fixed, will stretch into the primary spring 310 periphery in the propelling movement pole 100 and paint UV earlier and glue, then it is fixed with the bonding of propelling movement pole 100 inner wall, and in order to guarantee bonding strength between them, the length that primary spring 310 stretches into propelling movement pole 100 is greater than 5mm.

The proximal end of the handle 200 also has a circuit connector 210 for connecting with an external circuit, and the first wire 313 and the second wire 314 are connected to the circuit connector 210 in a direct or indirect manner, in this embodiment, indirectly, and the first wire 313 and the second wire 314 are connected to the circuit connector 210 through the handle 200.

In order to reduce interference on the state change of the primary spring 310, the heating wire 300 has two straight sections at the proximal end of the primary spring 310, wherein one straight section 330 is used for straightening the proximal end of the primary spring 310, and the other straight section 331 is used for bending the distal end of the primary spring 310 back through the first channel 311 and extending out of the first channel 311;

the number of the second wires 314 is two, and the second wires are respectively welded to the corresponding straight sections, and the welding points 315 are arranged in a staggered manner.

The staggered arrangement of the two solder joints 315 can prevent the danger of short circuit caused by too close distance, and further, the soldered solder joints 315 can be coated with UV glue for insulation.

The handle 200 includes a driving board for driving the vein rf ablation system to operate, as shown in fig. 5, the driving board includes a circuit board 211 and an electronic component 212 disposed on the circuit board 211, there are two first wires 313, one of the two first wires 313 is used for connecting an anode, the other is used for connecting a cathode, the two second wires 314 have no requirement for the anode and the cathode, in this embodiment, two positions, i.e., E-and E +, are used for connecting the second wires 314 (one of them can be optionally connected), the first wire 313 used for connecting the anode is welded to the RD position, and the first wire 313 connected to the cathode is welded to YE.

To start and stop heating, the handle 200 is provided with a switch 220 connected to the second wire 314 for controlling the on/off of the second wire 314. The heating element can be controlled to start or stop heating accordingly by operating the switch 220.

The outer surface of the heating wire 300 is provided with an insulating layer in consideration of safety. Of course, in order to enhance the insulation effect, the heating wire 300 may also be sleeved in an insulating heat shrink tube for double insulation protection.

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

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

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

The vein radio frequency ablation system has the following technical effects:

1. the catheter has a diameter of 4F, and can be placed in a smaller blood vessel compared with the catheters of 6F and 7F in the prior art.

2. The diameter and the length of the secondary spring are selected in multiple ways, the size of the heating element can be selected according to the diameter adaptability of the blood vessel, the heating element can be tightly attached to the blood vessel wall after being released, varicose veins can be treated by adopting lower temperature, and the risk of vessel burn is reduced.

The invention also provides a processing method using the vein radiofrequency ablation system, as shown in fig. 8, comprising the following steps:

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

step S200, spirally winding and heat-treating and shaping the heating wire 300 to obtain a primary spring 310, wherein the diameter of the primary spring 310 is 0.6-1.0 mm;

s300, spirally winding and heat-treating the primary spring 310 integrally to obtain a secondary spring 320, wherein 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 a push rod 100 with a handle 200 on one end of a secondary spring 320;

step S500, the secondary spring 320 is stretched and then penetrates into the catheter 400 with the catheter seat 401, and the venous radio frequency ablation system can be obtained.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features. Features of different embodiments are shown in the same drawing, which is to be understood as also disclosing combinations of the various embodiments concerned.

The above-mentioned embodiments only express several implementation modes of the present application, and the description thereof is specific and detailed, but not construed as limiting the scope of the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.

Claims (10)

1. A venous radio frequency ablation system, comprising:

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 heating wire, the heating wire being a conductive memory material and being helically wound into a primary spring, the 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 springs are relatively straightened;

a catheter having a catheter hub at a distal end thereof, the heating element penetrating into the interior of the catheter via the catheter hub in a stretched state.

2. The venous radio frequency ablation system of claim 1, wherein the primary spring has a first lumen defined therein, a thermocouple secured within the first lumen, and a first wire connected to the thermocouple and extending proximally through the first lumen and the push rod to the handle.

3. The venous radio frequency ablation system of claim 2, wherein an axial spacing of 6-20 mm is left between the distal tip of the thermocouple and the distal tip of the primary spring.

4. The venous radio frequency ablation system of claim 2, wherein a proximal end of the primary spring is inserted and secured within the push rod, and a second wire is connected to the heating wire and extends proximally through the push rod to the handle.

5. The venous radio frequency ablation system according to claim 4, wherein a circuit connector is further arranged at the proximal end of the handle, the first lead and the second lead are both connected to the circuit connector, and a switch which is connected with the second lead and controls the second lead to be switched on and off is mounted on the handle.

6. The venous radio frequency ablation system of claim 4, wherein at the proximal end of the primary spring, the heating wire has two straight sections, one of the straight sections being the proximal end of the primary spring stroked straight and the other straight section being the portion where the distal end of the primary spring is folded back through the first lumen and extends out of the first lumen;

the two second wires are respectively welded and cut to the corresponding straight sections, and welding points are arranged in a staggered mode.

7. The venous radio frequency ablation system of claim 1, wherein the heating wire is externally insulated.

8. The venous radio frequency ablation system of claim 1, wherein the heating wire has a diameter of 0.1-0.2 mm and the primary spring has a diameter of 0.6-1.0 mm.

9. The venous radio frequency ablation system of claim 1, wherein the secondary spring has a diameter of 2-20 mm and a length of 3-20 cm.

10. The method of manufacturing a venous radio frequency ablation system according to any of claims 1 to 9, comprising:

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

s200, spirally winding and heat-treating the heating wire for shaping to obtain a primary spring, wherein the diameter of the primary spring is 0.6-1.0 mm;

s300, spirally winding and heat-treating the primary spring to form a secondary spring, wherein 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 to one end of the secondary spring;

and S500, stretching the secondary spring and penetrating the secondary spring into a catheter with a catheter holder to obtain the venous radio-frequency ablation system.

Images