CN111067617A

CN111067617A - Radio frequency closure catheter and method of making same

Info

Publication number: CN111067617A
Application number: CN201911375916.4A
Authority: CN
Inventors: 刘震杰; 符伟国; 郑凯
Original assignee: Suzhou Hengrui Hongyuan Medical Technology Co ltd
Current assignee: Suzhou Hengrui Hongyuan Medical Technology Co ltd
Priority date: 2019-12-27
Filing date: 2019-12-27
Publication date: 2020-04-28
Also published as: CN113729926B; CN113729926A

Abstract

The invention discloses a radio frequency closed catheter, which mainly comprises: the heating tube comprises a tube body, a handle device, a connecting cable and a connector, wherein the tube body, the handle device, the connecting cable and the connector are sequentially connected from a far end to a near end, the tube body is sequentially provided with a rubber head, a heating section and a main tube from the far end, the surface of the heating section is provided with an insulating outer sleeve with insulating and smooth functions, a coil used for heating and formed by alloy wires in a winding mode is arranged inside the heating section, the coil comprises a near-end coil and a far-end coil, extension lines of the near-end coil and the far-end coil respectively pass through an inner cavity of the main tube and extend to the handle device, the connecting cable is connected to the connector, and the connector is connected with external equipment to provide radio-frequency current. The radio frequency closing catheter can realize the radio frequency closing of two pathological changes of lower limb superficial varicosity and traffic varicosity under the condition of not changing instruments, avoids related operation risks and shortens operation time.

Description

Radio frequency closure catheter and method of making same

Technical Field

The invention relates to a medical apparatus for interventional therapy, in particular to a radio frequency closed catheter for treating lower limb superficial veins and traffic varicose veins and a manufacturing method thereof.

Background

Varicose veins of the lower limbs are the most common intravascular diseases, with varicose veins of the greater origin being the most common. The prevalence rates of adults and women in China are respectively 10-15% and 20-25%, and the latest statistical results of the world health organization show that more than 1 hundred million people suffer from lower limb varicose veins in China, which becomes one of the main disease categories of various primary hospitals in China. The clinical manifestations of varicose vein of lower limb are that superficial blood vessels of leg skin are like earthworm varicose, the varicose is in a bulk or knot shape and obviously protrudes out of skin, and other main symptoms comprise skin pigmentation, even ulcer, pain, swelling, burning sensation, pruritus and the like. The pathological mechanism of varicose veins is complex, mainly comprises weak vein wall, congenital venous valve defect, high superficial venous pressure, living environment influence, heredity and the like, is the most obvious symptom of chronic venous insufficiency, and obviously influences the life quality and the beauty of patients.

The treatment of varicose vein of lower limb includes three major categories of conservative treatment, injection of sclerosing agent and surgical treatment. Conservative treatment is suitable for the onset of mild and no obvious symptoms, and includes compression socks, elastic bandages, inflation and compression, and also includes treatment with drugs such as fibrinolytic drugs and prostaglandin E1. The injection hardening treatment means that varicose veins are directionally removed through the injection of a hardening agent, varicose vessels under fascia of a patient with venous malformation are hardened, the veins are converted into fiber ropes, the efficacy of the injection hardening treatment is equivalent to surgical excision of the varicose veins, and the injection hardening treatment is mainly applied to light symptoms and postoperative adjuvant therapy. The injection therapy is accompanied by some complications such as extravasation of drug solutions, thrombosis with pain, allergic reactions, deep vein thrombosis, etc.

Minimally invasive surgery treatment has become an effective surgical means for treating varicose veins at present due to the advantages of small trauma, beautiful incision, few complications and the like, and the treatment of varicose veins of lower limbs through minimally invasive surgery has become a trend. Minimally invasive procedures that can treat varicose veins of the lower extremities include electrocoagulation, planing aspiration, laser therapy, and radiofrequency ablation. Compared with other minimally invasive surgeries, the radio frequency ablation therapy has more advantages in the aspects of pain relief, life quality and recovery speed of patients, the patients can move normally after the surgeries, meanwhile, the recurrence rate after the surgeries is low, postoperative complications are few, and special pain-relieving medicines are hardly needed.

The current radio frequency ablation therapy still has some aspects to be improved, for example, in the radio frequency ablation therapy of the superficial veins and the vena cava of the lower limbs, because different instruments are required to be used in the superficial vein surgery and the vena cava surgery, the risk of instrument replacement is caused, and the surgery time is prolonged.

Disclosure of Invention

The invention provides a radio frequency closed catheter and a manufacturing method thereof, which can realize radio frequency ablation of two lesion parts of lower limb superficial varicosity and traffic varicosity without changing instruments, wherein a far-end coil is independently used for treating the traffic varicosity, and the far-end coil and a near-end coil are jointly used for treating the lower limb superficial varicosity, so that the risk of instrument change is avoided, and the operation time is shortened.

The technical scheme of the invention is as follows:

a radio frequency closure catheter, consisting essentially of:

the heating tube comprises a tube body, a handle device, a connecting cable and a connector, wherein the tube body, the handle device, the connecting cable and the connector are sequentially connected from a far end to a near end, a rubber head, a heating section and a main tube are sequentially arranged on the tube body from the far end, an insulating outer sleeve with insulating and smoothing functions is arranged on the surface of the heating section, a coil used for heating and formed by alloy wires in a winding mode is arranged inside the heating section, the coil comprises a near-end coil and a far-end coil, at least one of the near-end coil and the far-end coil is short in width smaller than 4.0cm, extension lines of the near-end coil and the far-end coil respectively extend to the handle device through an inner cavity of the main tube and are connected to the connector through the connecting cable, and the connector is connected with external equipment to provide radio-.

In a preferred embodiment, the total width of the proximal coil and the distal coil is the same or different.

In a preferred embodiment, the total width of the distal coil is 0.3-4.0cm, the total width of the proximal coil is 4.0-8.0cm, and the distance between the distal coil and the proximal coil is 0-2 mm; the distal coil and the proximal coil each comprise at least one segment of a coil.

In a preferred embodiment, the heating section further comprises a coil inner sleeve, the far-end coil or the near-end coil is formed by winding at least one alloy wire on the coil inner sleeve by taking a folding point as a starting point after the at least one alloy wire is folded in half at the middle position, and the gap between the alloy wires is designed to be 0-0.15 mm; the coil inner sleeve is provided with at least two small holes, and the extension line of each alloy wire penetrates into the inner cavity of the coil inner sleeve through one small hole.

In a preferred embodiment, the coil inner sleeve is a single-lumen tube, and the material for manufacturing the coil inner sleeve is selected from one of polyether-ether-ketone or polyimide; the alloy wire is made of 52 alloy, a polyimide insulating coating is arranged on the surface of the alloy wire, and the outer diameter of the alloy wire is 0.1-0.2 mm.

In a preferred embodiment, the coil wound by the alloy wire is fixedly bonded with the inner sleeve of the coil by glue.

In the preferred embodiment, still include wire guide pipe and seal wire mouth, wire guide pipe's one end is followed the interior distal end opening of sleeve pipe of coil penetrates, penetrates in proper order the inner chamber of sleeve pipe, main part pipe and handle in the coil, and insert the distal end inner chamber of seal wire mouth, use glue will wire guide pipe with the interface bonding of seal wire mouth is fixed.

In a preferred embodiment, an unwrapped interval of 0.5-3.0mm is left in the middle of each section of the distal coil or the proximal coil, and a temperature measuring device is arranged in at least one unwrapped interval and comprises at least one temperature sensor for measuring the temperature of the inner wall of the blood vessel.

In a preferred embodiment, the temperature measuring device further comprises a temperature measuring ring for conducting the temperature of the inner wall of the blood vessel, and the temperature measuring ring is fixed on the unwound interval.

In a preferred embodiment, the temperature measuring head end of the temperature sensor is arranged in the non-winding interval and is not in direct contact with the coil; the extension line of the temperature sensor penetrates through the threading hole arranged on the coil inner sleeve or the threading holes respectively arranged on the temperature measuring ring and the coil inner sleeve to enter the inner cavity of the coil inner sleeve, and the extension line of the temperature sensor is connected to the connector through the inner cavity of the main body tube, the handle and the connecting cable.

In a preferred embodiment, the orientation of the alloy wire is along the axial direction of the radio frequency closure catheter in the non-winding interval; the temperature measuring ring is in the shape of a complete ring or a C-shaped ring; the material of the temperature measuring ring is selected from one of platinum-iridium alloy, platinum, gold and stainless steel; the inner diameter of the temperature measuring ring is 1.3-2.0mm, the outer diameter of the temperature measuring ring is 1.4-2.1mm, and the width of the temperature measuring ring is 0.5-2.5 mm.

In a preferred embodiment, the tube body further comprises a glue head, the glue head is arranged at the far end of the heating section, and the glue head is a circular glue head formed by curing epoxy resin glue or UV glue.

In a preferred embodiment, the main tube is a multilayer single lumen braided tube.

Based on the same inventive concept, the invention also provides a radio frequency closure catheter, which comprises a heating section close to the far end, wherein the heating section comprises a coil which can be connected with a power supply, is used for heating and is formed by winding alloy wires, the coil comprises a near-end coil and a far-end coil which are respectively connected with the power supply, and the widths of the near-end coil and the far-end coil are the same or different.

Based on the same inventive concept, the invention also provides a manufacturing method of the radio frequency closed catheter, which comprises the following manufacturing method steps of the temperature measuring device:

a C-shaped ring is arranged and fixed in the middle of each section of coil on the inner sleeve of the coil, which is not wound at intervals, the edges of the two sides of the C-shaped ring are not contacted with the alloy wire, and the cross opening of the C-shaped ring is positioned at the two sides of the straight section part of the alloy wire arranged along the axial direction of the catheter and is not contacted with the alloy wire; a threading hole is formed in one side of the near end of the C-shaped ring and the surface of the coil inner sleeve in the gap of the alloy wire, the head end of the temperature sensor is fixed by glue at the center of the outer surface of the C-shaped ring, and the extension line of the temperature sensor penetrates into the inner cavity of the coil inner sleeve through the threading hole and is connected to the connector through the inner cavity of the main body tube, the handle and the connecting cable.

a threading hole is formed in the middle position, not wound and spaced, of each section of coil on the coil inner sleeve, meanwhile, the head end of the temperature sensor is fixed to the middle position, not wound and spaced, of the surface of the coil inner sleeve by using glue, the extension line of the temperature sensor penetrates through the threading hole in the surface of the coil inner sleeve to enter the inner cavity of the coil inner sleeve, and the extension line of the temperature sensor passes through the inner cavity of the main body tube, the handle and the connecting cable until the extension line is;

and sleeving a complete temperature measuring ring at the non-winding interval of the coil, keeping the temperature measuring ring to completely cover the head end of the temperature sensor, enabling two sides of the temperature measuring ring not to be in contact with the alloy wires on two sides, and filling a gap between the temperature measuring ring and the inner sleeve of the coil by using glue to fix the temperature measuring device.

the method comprises the steps that the position of a temperature measuring device is predetermined on a coil inner sleeve, a complete temperature measuring ring is fixed on the surface of the coil inner sleeve at the position by glue, a threading hole is formed in the middle of the temperature measuring ring and penetrates through the coil inner sleeve in the inner layer, an extension line of a temperature sensor penetrates into an inner cavity of the coil inner sleeve through the threading hole, and the head end of the temperature sensor is fixed in the middle of the surface of the temperature measuring ring;

the method comprises the following steps of winding an alloy wire on the surface of an inner sleeve of a coil from a far end to the far end side of a temperature measuring ring according to a preset coil position, wherein the alloy wire is wound to cover the far end surface of the temperature measuring ring by 0.1-0.3mm, fixing the wound alloy wire by using glue, and continuously winding the alloy wire on the surface of the temperature measuring ring at a position which is 0.1-0.3mm away from the near end edge until the required width of the coil is reached;

the extension line of the alloy wire penetrates into the inner cavity of the coil inner sleeve through a small hole on the surface of the coil inner sleeve.

a threading hole is formed in the middle position, which is not wound at intervals, of each section of coil in the coil inner sleeve, the head end of the temperature sensor is fixed to the middle position, which is not wound at intervals, of the surface of the coil inner sleeve, the extension line of the temperature sensor penetrates through the threading hole of the coil inner sleeve to enter the inner cavity and passes through the inner cavity of the main body pipe, the handle and the connecting cable until the extension line is connected to the connector;

and feeding the complete temperature measuring ring from the far end of the coil until the temperature measuring ring completely covers the head end of the temperature sensor and the non-winding interval of the coil, wherein the edges of two sides of the temperature measuring ring at least cover 0.14 mm-wide alloy wires, and the gap part between the inner sleeve of the coil and the temperature measuring ring is filled with glue.

the method comprises the steps of feeding a temperature measuring ring from the far end of a coil until the temperature measuring ring completely covers the non-winding interval of the coil, covering alloy wires with the width of 0.14mm at least on the edges of two sides of the temperature measuring ring, opening a threading hole in the middle of the temperature measuring ring, penetrating the threading hole into an inner sleeve of the coil on an inner layer, penetrating an extension line of a temperature sensor into an inner cavity of the inner sleeve of the coil through the threading holes of the temperature measuring ring and the inner sleeve of the coil, fixing the temperature measuring head end of the temperature sensor at the middle position of the outer surface of the temperature measuring ring, and filling a gap between the.

the middle position of the gap is not wound to the coil on the surface of the coil inner sleeve is provided with a threading hole, the extension line of the temperature sensor penetrates into the inner cavity of the coil inner sleeve through the threading hole of the coil inner sleeve, the extension line of the temperature sensor is connected to the connector through the inner cavity of the main body pipe, the handle and the connecting cable, and the head end of the temperature sensor is fixed to the middle position of the gap, which is not wound to the coil on the surface of the coil inner sleeve, by glue.

Compared with the prior art, the invention has the following beneficial effects:

first, the radio frequency closure catheter of the present invention can achieve radio frequency closure of two lesion sites of superficial varicose vein of lower limb and varicose vein by using the same radio frequency closure catheter through the design of the distal coil and the proximal coil, especially at least one of the distal coil or the proximal coil is designed with a short width, preferably the design of the distal coil and the proximal coil with different widths, one of the distal coil and the proximal coil is designed with a short width, and the other is designed with a long width.

Secondly, the radio frequency closed catheter and the corresponding manufacturing method provided by the invention have the advantages that the temperature measuring rings and the temperature sensors are arranged at the middle part of the coil at intervals without winding, or the temperature sensors are independently arranged, so that the multipoint temperature measurement of the whole heating section can be realized, the axial multipoint temperature of the treatment section can be monitored, the more accurate and more comprehensive real-time feedback of the temperature in the ablation process can be obtained, and the higher success rate and the higher safety of the operation can be ensured.

Thirdly, according to the radio frequency closed conduit and the manufacturing method thereof, the head end of the temperature sensor is isolated from the alloy wire of the heating coil, so that more tissue temperature measurement can be realized, the temperature measurement feedback is more direct, and the radio frequency closure is safer.

Fourthly, the main body pipe of the radio frequency closed catheter adopts the multilayer woven net pipes, so that the effects of good flexibility, hardness and pushing performance of the pipe body of the radio frequency closed catheter are realized, and the pipe body can be bent at a large angle without being damaged, so that the radio frequency closed catheter can better pass through tortuous blood vessels and is suitable for more complicated pathological changes.

Of course, it is not necessary for any product in which the invention is practiced to achieve all of the above-described advantages at the same time.

Drawings

FIG. 1 is a schematic view of a radio frequency closure catheter product according to an embodiment of the present invention;

FIG. 2 is a partial schematic view of a heating section of a radio frequency closed catheter in accordance with an embodiment of the present invention;

FIG. 3 is a partial schematic view of the connection of the inner sleeve and the main tube of the RF closure catheter coil of an embodiment of the present invention;

FIG. 4 is a schematic diagram of a first embodiment of a RF closed conduit thermometry apparatus according to an embodiment of the present invention;

FIG. 5 is a schematic diagram of a second embodiment of a RF closed conduit thermometry apparatus according to an embodiment of the present invention;

FIG. 6 is a schematic diagram of a third embodiment of a RF closed conduit thermometry apparatus according to an embodiment of the present invention;

FIG. 7 is a fourth embodiment of a RF closed conduit thermometry apparatus according to an embodiment of the present invention;

FIG. 8 is a schematic diagram of a fifth embodiment of a RF closed conduit thermometry apparatus according to an embodiment of the present invention;

FIG. 9 is a schematic diagram of a sixth embodiment of a device for measuring temperature of a radio frequency closed catheter in accordance with an embodiment of the present invention.

Detailed Description

The invention provides a radio frequency closing catheter, which can be used for thermally closing the superficial veins of lower limbs and blood vessels with traffic varicose veins without replacing instruments, so as to achieve the purpose of treating varicose veins of lower limbs. In particular, the radio frequency closed catheter provided by the invention can be used for radio frequency ablation treatment of the lower limb superficial vein and the traffic vein simultaneously, so that the operation time is shortened, and the risk of replacing instruments is reduced. In addition, the temperature measurement structure of the radio frequency closed catheter and the manufacturing method thereof can monitor the contact temperature of the blood vessel in real time during radio frequency ablation treatment, so that the temperature measurement result is more visual and accurate, and the operation is safer.

The invention relates to a radio frequency closed catheter, which mainly comprises:

from the shaft of distal end to near-end order connection, handle device, connecting cable and connector, the shaft starts to be equipped with the head of gluing that the order connects from the distal end, section and main part pipe generate heat, the section surface that generates heat is equipped with the insulating outer tube that is used for insulating and smooth effect, inside is equipped with and is used for the heating, the coil that forms by the alloy silk coiling, the extension line of coil extends to handle device through the inner chamber of main part pipe, and then extends to the connector through connecting cable, external equipment is connected in order to provide radio frequency current to the connector.

Specifically, the insulating outer sleeve can be a single-cavity tube, can be tightly attached to the surface of the coil in a high-temperature thermal contraction mode, is made of one of FEP, PTFE and PET, and is 0.01-0.2mm thick.

Specifically, the heating section of the invention can also comprise a coil inner sleeve, and a coil wound by alloy wires is wound on the coil inner sleeve; the coil inner sleeve is provided with at least 2 small holes for the coil extension line to pass through and enter the inner cavity of the coil inner sleeve; the inner sleeve of the coil is a single-lumen tube, and the manufacturing material is one of PEEK (polyether ether ketone) or P I (polyimide).

Particularly, at least two sections of coils formed by respectively winding alloy wires are wound on the surface of the inner sleeve of the coil to form a far-end coil and a near-end coil, the width of the far-end coil is 0.3-4.0cm, the width of the near-end coil is 4.0-8.0cm, and the distance between the far-end coil and the near-end coil is 0-2.0 mm.

Specifically, each coil of the present invention may be formed by folding an alloy wire in half at the middle position, and then winding the alloy wire around the inner sleeve of the coil using the folding point as a starting point.

The alloy wire is used for radio frequency heating, and specifically, the alloy wire is made of 52 alloy (Al l oy52), the surface of the alloy wire is provided with a P I (polyimide) insulating coating, and the outer diameter of the alloy wire is 0.1-0.2 mm.

The coil is formed by winding the alloy wires, and the gaps among the alloy wires are designed to be 0-0.15 mm.

Particularly preferably, the coil wound by the alloy wire is provided with an un-wound interval of 0.5-3.0mm left in the right middle of each section of the coil and used for installing a temperature measuring device, and the temperature measuring device preferably comprises a temperature measuring ring and a temperature sensor for conducting and measuring the temperature of the inner wall of the blood vessel. Because the radio frequency closed catheter at least comprises the two sections of coils of the far-end coil and the near-end coil, at least two groups of temperature measuring devices can be arranged with at least two non-winding intervals. Therefore, the multi-point temperature measurement of the whole heating section can be realized, the axial multi-point temperature of the treatment section can be monitored, the temperature of the ablation process can be fed back in real time more accurately and comprehensively, and the higher success rate and the higher safety of the operation can be ensured.

More specifically, the coil wound by the alloy wire comprises a temperature measuring ring and at least one temperature sensor at the non-winding interval at the right middle position of each section of the coil.

Specifically, the shape of the temperature measuring ring is designed into a complete ring and a C-shaped ring, the temperature measuring ring is made of one of platinum-iridium alloy, platinum, gold and stainless steel, the inner diameter range is 1.3-2.0mm, the outer diameter is 1.4-2.1mm, and the width is 0.5-2.5 mm.

Preferably, the temperature sensor is arranged at the non-winding interval of each section of coil, but the temperature measuring head end of the temperature sensor is not in direct contact with the alloy wire. The head end of the temperature sensor is isolated from the alloy wire of the heating coil, so that more tissue temperature measurement can be realized, the temperature measurement feedback is more direct, and the radio frequency closing is safer.

Specifically, the glue head is a circular glue head formed by curing epoxy resin glue or UV glue.

Preferably, the main tube is a multi-layer single-cavity braided tube, the outer layer is made of Pebax7233 or PA12, the middle layer is made of 304 stainless steel wire mesh braided, the inner layer is made of Pebax or PA12, and the Shore hardness of the PA12 material is 77D. The main body pipe is preferably a multilayer woven net pipe, so that the pipe body of the catheter is good in flexibility, hardness and pushing performance, and can be bent at a large angle without being damaged, so that the catheter can better pass through tortuous blood vessels and is suitable for more complicated pathological changes.

Specifically, the 5mm-15mm part of the near end of the inner sleeve of the coil is embedded into the inner cavity of the far end of the main body tube and is fixed by welding or bonding with epoxy resin glue, so that the heating section is connected with the main body tube.

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. 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 invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Example 1

Referring to fig. 1, the radio frequency closed catheter of the present embodiment is sequentially provided with a rubber head 1, a heating section 2, a main tube 3, a stress release tube 5, a handle 6, a wire guide opening 7, a connection cable 8 and a connector 9 from a distal end to a proximal end, wherein the rubber head 1, the heating section 2 and the main tube 3 are sequentially arranged from the distal end to the proximal end to form a catheter body 4. The stress release tube 5 is sleeved at the near end of the main tube 3, the far end outlet of the handle 6 is fixedly connected with the near end of the main tube 3, and the far end outlet of the handle 6 is also fixedly connected with the near end of the stress release tube 5. The guidewire port 7 is located at the proximal end of the handle 6. One end of the connecting cable 8 is electrically connected with the heating section 2 at the handle 6, and the other end is electrically connected with the connector 9. The connector 9 is used to connect an external device to provide radio frequency current.

Referring to fig. 2, the heating section 2 includes an inner coil sleeve 10, two coils formed by winding alloy wires 11, and an outer insulating sleeve 12; wherein,

the coil inner sleeve 10 is a single-lumen tube, and two sections of coils, each formed by folding and winding an alloy wire 11, are arranged on the surface of the single-lumen tube, and the two sections of coils are preferably designed in the embodiment and are respectively a narrower distal coil and a wider proximal coil shown in fig. 2; wherein, the width of the far-end coil is 0.3-4.0cm, the width of the near-end coil is 4.0-8.0cm, the length of the alloy wire 11 used for winding the far-end coil is 30-120cm, and the length of the alloy wire 11 used for winding the near-end coil is 120-260 cm; the distance between the winding starting point of the far-end coil and the far-end opening of the coil inner sleeve 10 is 1-10mm, and the distance between the winding starting point of the near-end coil and the winding end point of the far-end coil is 0-2 mm; in the winding process of each section of coil, gaps of 0-0.15mm need to be reserved among all the alloy wires 11; and,

a section of non-winding interval with the width of 0.5-3.0mm is reserved on the far-end coil and the near-end coil respectively, and the non-winding interval is preferably positioned in the middle of each section of coil; and specifically, on the surface of each section of coil which is not wound with intervals, the running direction of the alloy wire 11 is along the axial direction of the radio frequency closed catheter; and,

the far-end coil or the near-end coil wound by the alloy wire 11 is fixedly bonded with the coil inner sleeve 10 by glue.

In the present embodiment, the material of the coil inner tube 10 is preferably a high temperature-resistant Polyetheretherketone (PEEK) or Polyimide (PI) material, specifically, for example, Polyetheretherketone (PEEK); the length of the inner sleeve 10 of the coil is 5.0-15.0mm, preferably 9.0-11.0mm, the inner diameter of the inner sleeve 10 of the coil is 1.0-1.7mm, the outer diameter is 1.2-1.9mm, preferably the inner diameter is 1.10-1.20mm, preferably the outer diameter is 1.30-1.40 mm.

Small holes, namely circular threading holes 14 and 15, are respectively formed at the coil winding end positions on the surface of the coil inner sleeve 10, and the extension lines of the two sections of coil alloy wires 11 are respectively threaded into the inner cavity of the coil inner sleeve 10 through the circular threading holes 14 and 15, as shown in fig. 2.

In the embodiment shown in fig. 2, the insulating outer sheath 12 is a single lumen tube capable of high temperature thermal contraction to be closely attached to the surface of the coil wound by the alloy wire 11, and is made of one material selected from FEP, PTFE and PET, and has a thickness of 0.01-0.2 mm.

In addition, as shown in fig. 1 and fig. 2, a guidewire tube 13 is further inserted into the radio frequency closure catheter, one end of the guidewire tube penetrates through the distal opening of the inner sleeve 10 of the coil, passes through the inner cavity of the main tube 3 and the inner cavity of the handle 6, and the other end of the guidewire tube is inserted into the distal inner cavity of the guidewire port 7 and is connected and communicated with the guidewire port 7.

As shown in fig. 3, the connection of the inner sleeve 10 of the coil to the main tube 3 is shown. Specifically, at the proximal end orifice of the coil inner sleeve 10, extension lines of the alloy wires 11 are respectively cut to different lengths, all the alloy wires 11 should be at least exposed out of the proximal end orifice of the coil inner sleeve 10 by 0.5mm, and the proximal end and the head end of all the alloy wires 11 are respectively connected with a copper lead 16 with the length of 100cm by soldering.

Specifically, the alloy wire 11 is made of 52 alloy (nickel-iron alloy) with a PI (polyimide) insulating coating on the surface, and the outer diameter of the alloy wire 11 is 0.1-0.2 mm. The copper wire 16 is made of copper wire with PI (polyimide) or PA (nylon) insulating coating on the surface, and the outer diameter of the copper wire 16 is 0.1-0.15 mm. Meanwhile, the inner diameters of the circular threading holes 14 and 15 on the inner sleeve 10 of the coil are 0.35-0.5 mm.

A temperature measuring device can be arranged on the non-winding interval between the far-end coil and the near-end coil which are wound by the alloy wires 11 on the coil inner sleeve 10. The specific structure and manufacturing method of the temperature measuring device will be described in detail in the following embodiments.

Temperature measuring device implementation mode one

Referring to fig. 4, in the present embodiment, each set of temperature measuring devices includes a temperature measuring ring 17 and a temperature sensor 18. The temperature measuring ring 17 is in the shape of a C-shaped ring.

As shown in fig. 4, in the present embodiment, the temperature measuring ring 17 is mounted at an intermediate position of the non-winding interval of the coil; the edges of two sides of the temperature measuring ring 17 are not contacted with the alloy wire 11 of the coil; the cross section opening of the temperature measuring ring 17 is positioned at two sides of the straight section part of the alloy wire 11 arranged along the axial direction of the radio frequency closed conduit and is not contacted with the alloy wire 11; the temperature measuring ring 17 is fixed on the surface of the inner sleeve 10 of the coil by glue, and the glue is preferably UV glue or Loctie 4011 glue.

Continuing to refer to fig. 4, on the surface of the coil inner sleeve 10, a circular threading hole 19 is formed in the gap position between the temperature measuring ring 17 and the proximal end side of the alloy wire 11, the aperture size is 0.15-0.3mm, the extension line of the temperature sensor 18 is threaded into the inner cavity of the coil inner sleeve 10 from the circular threading hole 19, and the extension line is connected to the connector 9 through the inner cavity of the main body tube 3, the handle 6 and the connecting cable 8 (please refer to fig. 1 in combination); the head end of the temperature sensor 18 is arranged at the surface center position of the temperature measuring ring 17 and is adhered and fixed by UV glue or Loctie 4011 glue.

In this embodiment, the thermometers of the remaining coil segments are arranged in the same manner as in the above example.

Second embodiment of temperature measuring device

Referring to fig. 5, in the present embodiment, each set of temperature measuring devices includes a temperature measuring ring 21 and a temperature sensor 18. The temperature measuring ring 21 is annular (i.e., a complete ring).

As shown in fig. 5, in the present embodiment, a circular threading hole 20 is formed on the surface of the inner sleeve 10 of the coil at the middle position of the non-winding interval of the coil, and the aperture size is 0.15-0.3 mm; an extension wire of the temperature sensor 18 is threaded into the inner cavity of the coil inner sleeve 10 from the threading hole 20, and then passes through the inner cavity of the main body tube 3, the handle 6 and the connecting cable 8 to be connected to the connector 9 (please refer to fig. 1 in combination); the head end of the temperature sensor 18 is arranged in the middle of the non-winding interval of the coil, the distance of 0.5-1.5mm is kept between the head end and the circular threading hole 20, and the head end of the temperature sensor 18 is fixedly bonded by UV glue or Letai 4011 glue.

With continued reference to fig. 5, the temperature measuring ring 21 is assembled in the middle of the non-winding interval of the coil, the temperature measuring ring 21 should completely cover the temperature sensor 18, and the two side edges of the temperature measuring ring 21 are not in contact with the alloy wires 11 of the coil, the temperature measuring ring 21 is fixed by using ethylene oxide glue, UV glue or lotai 4011 glue, specifically, the gap between the inner sleeve 10 of the coil and the temperature measuring ring 21 is sealed by using glue to fix the temperature measuring ring 21.

In this embodiment, the arrangement of the thermometers of the remaining coil segments is consistent with the above example.

Third embodiment of temperature measuring device

Referring to fig. 6, in the present embodiment, each set of temperature measuring devices includes a temperature measuring ring 31 and a temperature sensor 18. The temperature measuring ring 31 is annular (i.e. a complete ring).

As shown in fig. 6, the position of the coil is predetermined on the surface of the coil inner sleeve 10, and at the middle position of the coil at the predetermined non-winding interval, the temperature measuring ring 31 is fixed on the surface of the coil inner sleeve 10 by using glue, a circular threading hole 22 is opened at the middle position of the temperature measuring ring 31, the coil inner sleeve 10 inside the temperature measuring ring 31 of the circular threading hole 22 penetrates the extension line of the temperature sensor 18 into the inner cavity of the coil inner sleeve 10 through the circular threading hole 22, and the extension line is connected to the connector 9 through the inner cavity of the main body tube 3, the handle 6 and the connecting cable 8 (please refer to fig. 1 in combination); the head end of the temperature sensor 18 is arranged in the middle of the surface of the temperature measuring ring 31, and keeps a distance of 0.5-1.5mm with the circular threading hole 22, and meanwhile, the head end of the temperature sensor 18 is adhered and fixed by glue.

Then, winding an alloy wire 11 on the surface of the inner coil sleeve 10 from the far end to the far end side of the temperature measuring ring 31 according to the predetermined coil position, wherein the alloy wire 11 is wound to cover the far end of the temperature measuring ring 31 by 0.1-0.3mm, and fixing the wound alloy wire 11 by glue; and continuously winding the alloy wire 11 at the position of 0.1-0.3mm away from the near-end edge on the surface of the temperature measuring ring 31 until the winding width required by the section of the coil is finished, wherein the extension line of the alloy wire 11 penetrates into the inner cavity of the inner sleeve 10 of the coil through the threading hole 14.

In this embodiment, the glue may be ethylene oxide glue, UV glue, or loctite 4011 glue, preferably loctite 4011 glue.

In the present embodiment, the arrangement of the temperature measuring devices of the remaining coil segments is in accordance with the above example.

Temperature measuring device in accordance with fourth embodiment

Referring to fig. 7, in the present embodiment, each set of temperature measuring devices includes a temperature measuring ring 41 and a temperature sensor 18. In the present embodiment, the temperature measuring ring 41 has an annular outer shape.

As shown in fig. 7, in the present embodiment, a circular threading hole 23 is formed in the surface of the coil inner tube 10 at the middle position of the non-winding interval of the coil, the aperture size is 0.15-0.3mm, the extension line of the temperature sensor 18 is threaded into the inner cavity of the coil inner tube 10 from the circular threading hole 23, and the extension line is connected to the connector 9 through the inner cavity of the main tube 3, the handle 6 and the connection cable 8 (please refer to fig. 1 in combination); the head end of the temperature sensor 18 is arranged at the middle position of the non-winding interval of the coil, keeps a distance of 0.5-1.5mm with the circular threading hole 23, and is adhered and fixed by glue water.

The temperature measuring ring 41 is inserted into the middle position of the non-winding interval of the coil from the far end of the coil outer sleeve 10, the temperature measuring ring 41 completely covers the head end of the temperature sensor 18, and the two side edges of the temperature measuring ring 41 are covered with the alloy wires 11 with the width of 0.14-0.75 mm; the gap between the inner sleeve 10 of the coil and the temperature measuring ring 41 is sealed and fixed by glue.

In this embodiment, the glue is ethylene oxide glue, UV glue, or loctite 4011 glue.

In this embodiment, the temperature measuring devices of the remaining coil segments are arranged in the same manner as in the above example.

Temperature measuring device embodiment five

Referring to fig. 8, in the present embodiment, each set of thermometers includes a temperature ring 51 and a temperature sensor 18. In the present embodiment, the temperature measuring ring 51 has an annular outer shape.

As shown in fig. 8, in the present embodiment, a circular threading hole 24 is formed on the surface of the inner sleeve 10 of the coil at the middle position of the non-winding interval of the coil, and the aperture size is 0.15-0.3 mm; a circular threading hole 25 with the aperture size of 0.15-0.3mm is arranged at the middle position of the surface of the temperature measuring ring 51.

The temperature measuring ring 51 is penetrated from the far end of the coil outer sleeve 10 to the middle position of the non-winding interval of the coil; the extension line of the temperature sensor 18 is threaded into the threading hole 25 and the threading hole 24 to enter the inner cavity of the coil inner sleeve 10, and then the extension line passes through the inner cavity of the main tube 3, the handle 6 and the connecting cable 8 to be connected to the connector 9 (please refer to fig. 1 in combination); the head end of the temperature sensor 18 is arranged on the outer surface of the temperature measuring ring 51; filling a gap between the coil inner sleeve 10 and the temperature measuring ring 51 by using epoxy resin glue, and moving the temperature measuring ring 51 to enable the two side edges of the temperature measuring ring 51 to cover the alloy wires 11 with the width of 0.14-0.75 mm; the head end of the temperature sensor 18 is arranged in the middle of the outer surface of the temperature measuring ring 51, the distance of 0.5-1.5mm is kept between the head end and the threading hole 25, and the head end of the temperature sensor 18 is fixed by using UV glue or Letai 4011 glue.

Temperature measuring device embodiment six

In the present embodiment, the temperature measuring device does not have a temperature measuring ring, and includes only the temperature sensor 18.

Referring to fig. 9, in the present embodiment, a circular threading hole 26 is formed in the surface of the coil inner tube 10 at the middle position of the non-winding interval of the coil, the aperture size is 0.15-0.3mm, an extension line of the temperature sensor 18 is threaded into the inner cavity of the coil inner tube 10 from the threading hole 26, and the extension line subsequently passes through the inner cavity of the main tube 3, the handle 6 and the connecting cable 8 to be connected to the connector 9 (see fig. 1 in combination); the head end of the temperature sensor 18 is arranged at the middle position of the non-winding interval of the coil, the distance of 0.5-1.5mm is kept between the head end and the circular threading hole 26 in the circumferential direction, and the head end of the temperature sensor 18 is fixed by using UV glue or Letai 4011 glue.

In this embodiment, the temperature measuring devices of the remaining coil segments are identical to the above example.

In different embodiments of the radio frequency closed catheter, the temperature measuring devices of different coil sections can be arranged in any one of the six embodiments, and the arrangement is not limited to the same arrangement.

In this embodiment, the material of the temperature measuring ring can be selected from one of platinum-iridium alloy, platinum, gold and stainless steel, the inner diameter of the temperature measuring ring ranges from 1.3mm to 2.0mm, the outer diameter ranges from 1.4 mm to 2.1mm, and the width ranges from 0.5mm to 2.5 mm.

In the present embodiment, the temperature sensor 18 is a thermocouple, of the type K, with a cross-sectional dimension of 0.12 x 0.24mm and a length of 100 cm.

As shown in fig. 2, after the coil winding is completed and the temperature measuring device is set, the insulating outer sleeve 12 is sleeved on the outermost layer of the whole heating section 2, the distal end of the insulating outer sleeve 12 is kept flush with the distal end opening of the coil inner sleeve 10, and the insulating outer sleeve 12 is heat-shrunk by using a heat shrinker to completely wrap the heating section 2, wherein the heat-shrinking temperature is 200-260 ℃. Specifically, the insulating outer sleeve 12 may be made of FEP (fluorinated ethylene propylene copolymer), and has transparent color, wall thickness of 0.09-0.11mm, length of 10-15mm, expanded inner diameter > 1.9mm, and recovered inner diameter < 1.3 mm.

In the present embodiment, the guide wire tube 13 is shaped as a single lumen tube. When the guide wire tube 13 is installed, one end of the guide wire tube 13 penetrates through the distal end opening of the coil inner sleeve 10 and sequentially penetrates through the inner cavities of the coil inner sleeve 10, the main body tube 3 and the handle 6, the distal end of the guide wire tube 13 is exposed out of the distal end opening of the coil inner sleeve 10 by 1.0-5.0mm, preferably 2.0-3.0mm, the proximal end of the guide wire tube 13 is inserted into the distal end inner cavity of the guide wire opening 7, the insertion length is 0.3-1.0cm, and the interface is bonded and fixed by using epoxy resin glue or UV glue. Specifically, the material of the guide wire tube 13 may be PI (polyimide), with an inner diameter of 0.5 to 0.7mm and an outer diameter of 0.6 to 0.8 mm.

As shown in fig. 2, the rubber head 1 is located at the most distal end of the radio frequency closure catheter and is used for making the tip of the catheter smoother so as to ensure that the movement of the catheter during the operation does not damage the blood vessel. The material of the glue head 1 is epoxy glue or UV glue, specifically, the epoxy glue or UV glue is coated on the outer surface of the wire guide pipe 13 layer by layer and cured to form the glue head 1, and the shape of the glue head 1 is basically spherical, and the outer diameter is 1.5-2.33mm, preferably 1.7-2.1 mm.

Referring to fig. 3, all the extension lines of the copper wires 16 and the temperature sensor 18 penetrate into the inner cavity of the main tube 3, the surface of the proximal end of the coil inner tube 10 with a length of 5-10mm is coated with epoxy glue, and the glue coated portion of the coil inner tube 10 is embedded into the inner cavity of the main tube 3 to bond the coil inner tube 10 and the main tube 3. The main tube 3 is a multi-layer single-cavity braided tube, the outer layer is made of Pebax7233 or PA12, the middle layer is made of 304 stainless steel wire mesh braided, the inner layer is made of Pebax7233 or PA12, the used PA12 material has the Shore hardness of 77D, the inner diameter of the main tube is 1.20-1.80mm, and the outer diameter of the main tube is 1.65-2.25 mm.

Referring to fig. 1, a stress release tube 5 is sleeved on a proximal end of a main tube 3, extension lines of alloy wires 11 and a temperature sensor 18 are arranged at a proximal end opening of the main tube 3, all the extension lines of the alloy wires 11 and the temperature sensor 18 are welded on a circuit board inside a handle 6 by soldering, one end of a connection cable 8 is welded on the circuit board by soldering, the other end of the connection cable 8 is welded on a connector 9 by soldering, the proximal end of the main tube 3 is fixedly bonded to a distal outlet of the handle 6 by using tai 4011 glue, and the proximal end of the stress release tube 5 and the distal outlet of the handle 6 are fixedly bonded by using the tai 4011 glue.

Specifically, for example, the stress release tube 5 is made of silicon rubber, is shaped like a cylinder with a cavity, and has a length of 3-10 cm; the handle 6 is made of PC + ABS resin and is manufactured by adopting an injection molding processing technology, and the shape of the handle can be the shape of a handle of a conventional interventional instrument; the connector 9 is a standard component such as REDEL12 pin plastic connector available from remo (shanghai) trade limited.

The invention has the following advantages:

1. according to the radio frequency closed catheter, the far-end coil and the near-end coil are arranged and preferably designed to have different widths, so that radio frequency ablation of two lesion parts, namely the superficial varicose vein of the lower limb and the traffic varicose vein, can be realized under the condition that an instrument does not need to be replaced, wherein the short-width far-end coil is independently used for treating the traffic varicose vein, and the far-end coil and the near-end coil are jointly used for treating the superficial varicose vein of the lower limb;

2. according to the radio frequency closed catheter and the corresponding manufacturing method, the head end of the temperature sensor is isolated from the alloy wire of the coil for heating, so that more tissue temperature measurement can be realized, the temperature measurement feedback is more direct, and the radio frequency ablation is safer;

3. the radio frequency closed catheter comprises a plurality of coils, and the middle part of each coil is provided with the temperature measuring device, so that a plurality of groups of temperature measuring devices are arranged on the heating section of the whole radio frequency closed catheter, further the multipoint temperature measurement of the whole heating section can be realized, the axial multipoint temperature of the treatment section is monitored, more accurate and more comprehensive real-time feedback of the ablation process can be obtained, and the higher success rate and the higher safety of the operation are ensured;

4. according to the radio frequency closed catheter, the main body pipe adopts the multilayer woven net pipes, so that the good flexibility, hardness and pushing performance of the body of the radio frequency closed catheter are achieved, the body can be bent at a large angle without being damaged, the catheter can better pass through tortuous blood vessels, and the radio frequency closed catheter is suitable for more complicated pathological changes.

Finally, it should be noted that: the above examples and embodiments are only used to illustrate the technical solutions of the present invention, but not to limit the same; although the present invention has been described in detail with reference to the foregoing examples and embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments and implementations can be modified, or some or all of the technical features can be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention in its embodiments and implementations. The invention is limited only by the claims and their full scope and equivalents.

Claims

1. A radio frequency closure catheter, consisting essentially of:

2. The radio frequency closure catheter of claim 1, wherein the total width of the proximal coil and the distal coil are the same or different.

3. The radio frequency closure catheter of claim 1, wherein the distal coil has a total width of 0.3-4.0cm, the proximal coil has a total width of 4.0-8.0cm, and the distal coil is spaced 0-2mm from the proximal coil; the distal coil and the proximal coil each comprise at least one segment of a coil.

4. The radio frequency closure catheter according to claim 1, 2 or 3, wherein the heating section further comprises an inner coil sleeve, the distal coil or the proximal coil is formed by winding at least one alloy wire on the inner coil sleeve with a folding point as a starting point after the alloy wire is folded in half at the middle position, and the gap between the alloy wires is designed to be 0-0.15 mm; the coil inner sleeve is provided with at least two small holes, and the extension line of each alloy wire penetrates into the inner cavity of the coil inner sleeve through one small hole.

5. The radio frequency closure catheter according to claim 4, wherein the inner coil sleeve is a single lumen tube, and is made of a material selected from one of polyetheretherketone or polyimide; the alloy wire is made of 52 alloy, a polyimide insulating coating is arranged on the surface of the alloy wire, and the outer diameter of the alloy wire is 0.1-0.2 mm.

6. The radio frequency closure catheter of claim 4, wherein the coil wound from the alloy wire is adhesively secured to the inner sleeve of the coil with glue.

7. The radio frequency closure catheter according to claim 4, further comprising a guide wire tube and a guide wire port, wherein one end of the guide wire tube penetrates through the distal opening of the inner sleeve of the coil, sequentially penetrates through the inner cavities of the inner sleeve of the coil, the main tube and the handle, and is inserted into the distal inner cavity of the guide wire port, and the guide wire tube is fixedly bonded to the interface of the guide wire port by using glue.

8. The radio frequency closure catheter of claim 4, wherein each of the distal coil or the proximal coil segments has an unwound space of 0.5-3.0mm at a central location, at least one of the unwound spaces having a temperature measuring device disposed therein, the temperature measuring device including at least one temperature sensor for measuring a temperature of an inner wall of the blood vessel.

9. The radio frequency closure catheter of claim 8, wherein the thermometry device further comprises a thermometry ring that conducts the temperature of the inner wall of the vessel, the thermometry ring being fixed to the unwound space.

10. The radio frequency closure catheter of claim 9, wherein a temperature tip of the temperature sensor is disposed within the unwound interval and is not in direct contact with the coil; the extension line of the temperature sensor penetrates through the threading hole arranged on the coil inner sleeve or the threading holes respectively arranged on the temperature measuring ring and the coil inner sleeve to enter the inner cavity of the coil inner sleeve, and the extension line of the temperature sensor is connected to the connector through the inner cavity of the main body tube, the handle and the connecting cable.

11. The radio frequency closure catheter of claim 9, wherein the alloy wire runs in an axial direction of the radio frequency closure catheter in the unwound interval; the temperature measuring ring is in the shape of a complete ring or a C-shaped ring; the material of the temperature measuring ring is selected from one of platinum-iridium alloy, platinum, gold and stainless steel; the inner diameter of the temperature measuring ring is 1.3-2.0mm, the outer diameter of the temperature measuring ring is 1.4-2.1mm, and the width of the temperature measuring ring is 0.5-2.5 mm.

12. The radio frequency closure catheter of claim 1, wherein the shaft further comprises a glue head disposed at a distal end of the heating section, the glue head being a circular glue head formed by curing an epoxy glue or a UV glue.

13. The radio frequency closure catheter of claim 1, wherein the main tube is a multi-layer single lumen braided tube.

14. A radio frequency closed catheter is characterized by comprising a heating section close to a far end, wherein the heating section comprises a coil which can be connected with a power supply, used for heating and formed by winding an alloy wire, the coil comprises a near-end coil and a far-end coil which are respectively connected with the power supply, and the widths of the near-end coil and the far-end coil are the same or different.

15. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device:

16. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device:

17. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device:

18. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device:

19. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device:

20. A method of manufacturing a radio frequency closure catheter according to any of claims 8-11, comprising the following method steps of manufacturing the thermometric device: