CN113729926B - Radio frequency closure catheter and manufacturing method thereof - Google Patents
Radio frequency closure catheter and manufacturing method thereof Download PDFInfo
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- CN113729926B CN113729926B CN202111200587.7A CN202111200587A CN113729926B CN 113729926 B CN113729926 B CN 113729926B CN 202111200587 A CN202111200587 A CN 202111200587A CN 113729926 B CN113729926 B CN 113729926B
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00714—Temperature
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
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- Media Introduction/Drainage Providing Device (AREA)
Abstract
The invention discloses a radio frequency closure catheter, which mainly comprises: the heating device comprises a tube body, a handle device, a connecting cable and a connector, wherein the tube body is sequentially connected from a far end to a near end, a rubber head, a heating section and a main body tube are sequentially arranged on the tube body from the far end, an insulating outer sleeve with insulating and smooth functions is arranged on the surface of the heating section, a coil which is used for heating and is formed by winding alloy wires 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 extend to the handle device through an inner cavity of the main body tube, and the connection 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 radio frequency closing of two pathological change positions of superficial varicose veins and transit varicose veins of lower limbs under the condition of not needing to replace instruments, avoids related operation risks and shortens operation time.
Description
Technical Field
The invention relates to a medical instrument for interventional therapy, in particular to a radio frequency closure catheter for treating superficial veins of lower limbs and varicose veins of traffic and a manufacturing method thereof.
Background
Varicose veins of the lower limbs are the most common intravascular disease, with great saphenous varicose veins being the most common. The prevalence rates of adult men and women in China are respectively up to 10% -15% and 20% -25%, and the latest statistics results of the world health organization show that more than 1 million people suffer from varicose veins of lower limbs in China, and the disease rate is one of the main disease types of hospitals of various major bases in China. The clinical manifestations of varicose veins of the lower extremities are that superficial blood vessels of the leg skin are curved like earthworms, qu Zhangcheng are nodular or nodular, obviously bulge the skin, other major symptoms include skin pigmentation even ulcers, pain, swelling, burning sensation and itching, etc. The pathological mechanism of varicose veins is complex, mainly comprising weak vein wall, congenital vein valve defect, high superficial vein pressure, living environment influence, inheritance and the like, is the most obvious symptom of chronic vein insufficiency, and obviously affects the living quality and the beauty of patients.
Treatment of varicose veins of the lower extremities includes three major categories, conservative treatment, injection of sclerosant and surgical treatment. The conservative treatment is suitable for the morbidity with lighter degree and no obvious symptoms, and comprises the steps of pressure socks, elastic bandages, inflation pressurization and the like, and also comprises the steps of taking fibrinolytic medicines, prostaglandin E1 and other medicines for treatment. The injection hardening treatment refers to directional removal of varicose veins and hardening of varicose veins under fascia of patients with venous malformation by hardening agent injection, so that the veins are converted into fibrid 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 lighter symptoms and postoperative adjuvant treatment. Injection therapy may be accompanied by complications such as extravasation of medical fluids, thrombosis with pain, allergic reactions, deep vein thrombosis, and the like.
Minimally invasive surgery has become an effective surgical means for treating varicose veins due to the advantages of small trauma, attractive incision, few complications and the like, and minimally invasive treatment of varicose veins of lower limbs has become a trend. Minimally invasive procedures capable of treating varicose veins of the lower extremities include electrocoagulation, planing and aspiration, laser treatment and radio frequency ablation. Compared with other minimally invasive surgeries, the radio frequency ablation treatment has the advantages of relieving pain, quality of life and recovery speed of patients, the patients can normally move after the surgery, meanwhile, the postoperative recurrence rate is low, postoperative complications are few, and special pain relieving drugs are hardly needed.
There are still some aspects of the current rf ablation treatment that need to be improved, such as in rf ablation treatment of the superficial veins and the transit veins of the lower limb, which results in the risk of instrument replacement due to the need for different instruments in the superficial vein and the transit vein surgery, and also increases the surgery time.
Disclosure of Invention
The invention provides a radio frequency closure catheter and a manufacturing method thereof, which can realize radio frequency ablation of two pathological change positions of lower limb shallow varicose veins and transit varicose veins without replacing instruments, a far-end coil independently acts on the treatment of the transit varicose veins, and the far-end coil and a near-end coil are jointly used for the treatment of the lower limb shallow varicose veins, so that the risk of instrument replacement is avoided, and the operation time is shortened.
The technical scheme of the invention is as follows:
a radio frequency closure catheter, comprising essentially:
the heating device comprises a tube body, a handle device, a connecting cable and a connector, wherein the tube body is sequentially connected from a far end to a near end, a rubber head, a heating section and a main body tube are sequentially arranged on the tube body from the far end, an insulating outer sleeve with insulating and smooth functions is arranged on the surface of the heating section, a coil which is used for heating and is formed by winding alloy wires 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 of a short width below 4.0cm, and 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 body tube and are connected to the connector through the connecting cable, and the connector is connected with external equipment to provide radio-frequency current.
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 0-2mm; the distal coil and the proximal coil each include at least one segment of coil.
In a preferred embodiment, the heating section further comprises a coil inner sleeve, the distal coil or the proximal coil is formed by winding at least one alloy wire on the coil inner sleeve with a folding point as a starting point after being folded in half at the middle position, and a gap between the alloy wires is designed to be 0-0.15mm; at least two small holes are formed in the inner sleeve of the coil, and the extension line of each alloy wire penetrates into the inner cavity of the inner sleeve of the coil through one small hole.
In a preferred embodiment, the inner sleeve of the coil is a single-lumen tube, and the inner sleeve of the coil is made of a material selected from one of polyetheretherketone and polyimide; the alloy wire is made of 52 alloy, the surface of the alloy wire is provided with a polyimide insulating coating, and the outer diameter of the alloy wire is 0.1-0.2mm.
In a preferred embodiment, the coil wound by the alloy wire and the coil inner sleeve are adhered and fixed by glue.
In a preferred embodiment, the device further comprises a wire guide tube and a wire guide port, wherein one end of the wire guide tube penetrates from a distal end opening of the inner sleeve of the coil, sequentially penetrates into inner cavities of the inner sleeve of the coil, the main body tube and the handle, is inserted into the distal end inner cavity of the wire guide port, and the interface of the wire guide tube and the wire guide port is bonded and fixed by using glue.
In a preferred embodiment, an unwrapped interval of 0.5-3.0mm is left at the middle position 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, the temperature measuring ring being fixed on the unwrapped interval.
In a preferred embodiment, the temperature measuring head end of the temperature sensor is arranged in the unreeled interval and is not in direct contact with the coil; the extension line of the temperature sensor passes through the threading holes arranged on the coil inner sleeve or the threading holes respectively arranged on the temperature measuring ring and the coil inner sleeve, enters the inner cavity of the coil inner sleeve, passes through the inner cavity of the main body tube, the handle and the connecting cable and is connected to the connector.
In a preferred embodiment, in the non-winding interval, the alloy wire runs along the axial direction of the radio frequency closure catheter; the temperature measuring ring is in a complete ring or a C-shaped ring; the material of the temperature measuring ring is 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 0.5-2.5mm.
In a preferred embodiment, the pipe body further comprises a glue head, the glue head is arranged at the distal end of the heating section, and the glue head is a round glue head formed by curing epoxy resin glue or UV glue.
In a preferred embodiment, the main body tube is a multi-layer single lumen braided tube.
Based on the same inventive concept, the invention also provides a radio frequency closure catheter, which comprises a heating section near the distal end, wherein the heating section comprises a coil which can be connected with a power supply and is used for heating and is formed by winding an alloy wire, and the coil comprises a proximal coil and a distal coil which are respectively connected with the power supply, and the widths of the proximal coil and the distal 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:
the middle position of each section of coil on the inner sleeve of the coil, which is not wound, is provided with and fixed with a C-shaped ring, the edges of the two sides of the C-shaped ring are not contacted with the alloy wire, and the cross section opening of the C-shaped ring is positioned at the two sides of the straight section part of the alloy wire which is axially arranged along the catheter and is not contacted with the alloy wire; a threading hole is formed in the surface of the inner sleeve of the coil in a gap between one side of the proximal end of the C-shaped ring and the alloy wire, the head end of the temperature sensor is fixed at the center of the outer surface of the C-shaped ring by using glue, and an extension line of the temperature sensor penetrates into the inner cavity of the inner sleeve of the coil 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.
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 threading hole is formed in the middle position of each section of coil on the inner sleeve of the coil, which is not wound at intervals, meanwhile, the head end of the temperature sensor is fixed at the middle position of the surface of the inner sleeve of the coil by using glue, an extension line of the temperature sensor penetrates into the threading hole on the surface of the inner sleeve of the coil, enters into the inner cavity of the inner sleeve of the coil, and passes through the inner cavity of the main body tube, the handle and the connecting cable until being connected to the connector;
and a complete temperature measuring ring is sleeved at the winding-free interval of the coil, the temperature measuring ring is kept to completely cover the head end of the temperature sensor, two sides of the temperature measuring ring are not contacted with alloy wires on two sides, and the gap between the temperature measuring ring and the inner sleeve of the coil is filled with glue so as to fix the temperature measuring device.
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:
the method comprises the steps that the position of a temperature measuring device is preset on a coil inner sleeve, the surface of the coil inner sleeve at the position is fixed with a complete temperature measuring ring by using glue, a threading hole is formed in the middle of the temperature measuring ring, the threading hole penetrates through the coil inner sleeve of an 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;
winding alloy wires on the surface of the inner sleeve of the coil from the far end according to a preset coil position until the surface is wound to one side of the far end of the temperature measuring ring, wherein the alloy wires are wound to cover the surface of the far end of the temperature measuring ring by 0.1-0.3mm, fixing the wound alloy wires by using glue, and continuing to wind the alloy wires on the surface of the temperature measuring ring at a position 0.1-0.3mm away from the edge of the near end until the required width of the coil is reached;
the extension line of the alloy wire penetrates into the inner cavity of the inner sleeve of the coil through the small hole on the surface of the inner sleeve of the coil.
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 threading hole is formed in the middle position of each section of coil of the inner sleeve of the coil, which is not wound at intervals, the head end of the temperature sensor is fixed at the middle position of the surface of the inner sleeve of the coil, the extension line of the temperature sensor penetrates into the threading hole of the inner sleeve of the coil and enters the inner cavity, and the extension line passes through the inner cavity of the main body tube, the handle and the connecting wire until the extension line is connected to the connector;
and feeding the complete temperature measuring ring from the distal end of the coil until the temperature measuring ring completely covers the head end of the temperature sensor and the winding-free interval of the coil, wherein the two side edges of the temperature measuring ring are at least covered with alloy wires with the width of 0.14mm, and the gap between the inner sleeve of the coil and the temperature measuring ring is filled and sealed by glue.
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:
the method comprises the steps that a temperature measuring ring is fed from the far end of a coil until the temperature measuring ring completely covers the winding-free interval of the coil, alloy wires with the width of 0.14mm are at least covered on the edges of the two sides of the temperature measuring ring, a threading hole is formed in the middle of the temperature measuring ring, the threading hole penetrates through an inner coil inner sleeve of an inner layer, an extension line of a temperature sensor penetrates through the threading holes of the temperature measuring ring and the inner coil sleeve into an inner cavity of the inner coil sleeve, the temperature measuring head end of the temperature sensor is fixed at the middle position of the outer surface of the temperature measuring ring, and a gap between the temperature measuring ring and the inner coil sleeve is filled and sealed by glue.
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:
and a threading hole is formed in the middle position of the coil unreeling gap on the surface of the coil inner sleeve, an 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 tube, the handle and the connecting cable, and the head end of the temperature sensor is fixed at the middle position of the coil unreeling gap on the surface of the coil inner sleeve through glue.
Compared with the prior art, the invention has the following beneficial effects:
the radio frequency closing catheter of the first invention, through the design of the far-end coil and the near-end coil, particularly the design of at least one of the far-end coil or the near-end coil with a short width, preferably the design of the far-end coil and the near-end coil with different widths, one of the far-end coil and the near-end coil with a short width and the other with a long width, can realize the radio frequency closing of two pathological parts of the lower limb shallow varicose veins and the transit varicose veins by using the same radio frequency closing catheter, more preferably, for example, the far-end coil with the short width is used for treating the transit varicose veins independently, and the far-end coil and the near-end coil are used for treating the lower limb shallow varicose veins jointly, thereby avoiding the risk of instrument replacement and shortening the operation time.
According to the radio frequency closure catheter and the corresponding manufacturing method, the temperature measuring ring and the temperature sensor are arranged at the winding-free interval at the middle part of the coil, or the temperature sensor is arranged independently, so that the multi-point temperature measurement of the whole heating section can be realized, the axial multi-point temperature of the treatment section is monitored, the real-time feedback of the temperature in the more accurate and more comprehensive ablation process can be obtained, and the higher success rate and the higher safety of the operation are ensured.
Thirdly, according to the radio frequency closed catheter and the manufacturing method thereof, more tissue temperature measurement can be realized through the isolation of the head end of the temperature sensor and the alloy wire of the heating coil, so that temperature measurement feedback is more direct, and radio frequency closing is safer.
Fourth, the main body tube of the radio frequency closure catheter adopts the multi-layer woven net tube, so that the effect of excellent flexibility, hardness and pushability of the tube body of the radio frequency closure catheter is realized, the tube body can be bent at a large angle without damage, and the radio frequency closure catheter can better pass through tortuous vessels and is suitable for more complex lesion sites.
Of course, it is not necessary for any one product to practice the invention to achieve all of the advantages set forth above at the same time.
Drawings
FIG. 1 is a schematic view of an RF occlusive 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 closure catheter in accordance with an embodiment of the present invention;
FIG. 3 is a partial schematic view of the connection between the inner sleeve and the main tube of the RF-responsive catheter coil in accordance with an embodiment of the present invention;
FIG. 4 is a schematic diagram of a first embodiment of a radio frequency closed catheter thermometric apparatus according to an embodiment of the invention;
FIG. 5 is a schematic diagram of a second embodiment of a radio frequency closed conduit temperature measurement device according to an embodiment of the present invention;
FIG. 6 is a schematic diagram of a third embodiment of a radio frequency occlusive catheter temperature measurement device in accordance with an embodiment of the present invention;
FIG. 7 is a schematic diagram of a fourth embodiment of a radio frequency occlusive catheter temperature measurement device in accordance with an embodiment of the invention;
FIG. 8 is a schematic diagram of a fifth embodiment of a radio frequency occlusive catheter temperature measurement device in accordance with an embodiment of the present invention;
FIG. 9 is a schematic diagram of a sixth embodiment of a radio frequency occlusive catheter temperature measurement device in accordance with an embodiment of the invention.
Detailed Description
The invention provides a radio frequency closure catheter, which can thermally close the blood vessels of the superficial veins and the varicose veins of the lower limbs without replacing instruments, thereby achieving the purpose of treating the varicose veins of the lower limbs. In particular, the structure of the radio frequency closed catheter can be used for radio frequency ablation treatment of the superficial veins and the transit veins of the lower limbs, so that the operation time is shortened, and the risk of instrument replacement is reduced. In addition, the temperature measuring 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 measuring result is more visual and accurate, and the operation is safer.
The radio frequency closure catheter of the invention mainly comprises:
the utility model provides a from distal end to near-end sequentially connected's pipe shaft, handle device, connecting cable and connector, the pipe shaft is equipped with the rubber head that connects in proper order from the distal end, section and main part pipe generate heat, generate heat the section surface and be equipped with the insulating outer tube that is used for insulating and smooth effect, inside be equipped with be used for the heating, by the coil that alloy wire coiling formed, 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, the connector is connected external equipment in order to provide radio frequency current.
Specifically, the insulating outer sleeve can be a single-cavity tube, can be tightly attached to the surface of a coil by high-temperature heat shrinkage, is made of one of FEP, PTFE, PET and has a thickness of 0.01-0.2mm.
Specifically, the heating section of the invention can also comprise a coil inner sleeve, and a coil formed by winding an alloy wire is wound on the coil inner sleeve; at least 2 small holes are formed in the inner sleeve of the coil and used for allowing the coil extension wire to pass through and enter the inner cavity of the inner sleeve of the coil; the inner sleeve of the coil is a single-cavity tube, and the manufacturing material is one of PEEK (polyether ether ketone) or PI (polyimide).
Particularly, the surface of the inner sleeve of the coil is wound with coils formed by winding at least two sections of alloy wires respectively 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 0-2.0mm.
Specifically, each coil of the invention can be formed by winding an alloy wire on an inner sleeve of the coil by taking a folding point as a starting point after the alloy wire is folded in half at the middle position.
The Alloy wire is used for radio-frequency heating, specifically, the Alloy wire material is 52 Alloy (Alloy 52), the surface of the Alloy wire is provided with a PI (polyimide) insulating coating, and the outer diameter of the Alloy wire is 0.1-0.2mm.
The coil wound by the alloy wires is designed to have a gap of 0-0.15mm.
The coil wound by the alloy wire is particularly preferable, and an unreeling interval of 0.5-3.0mm is reserved at the middle position of each section of coil 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 a blood vessel. Because the radio frequency closed conduit at least comprises a far-end coil and a near-end coil, at least two groups of temperature measuring devices can be arranged with at least two unwrapped intervals. Therefore, the multi-point temperature measurement of the whole heating section can be realized, the axial multi-point temperature of the treatment section is monitored, the temperature real-time feedback of the more accurate and more comprehensive ablation process can be obtained, and the higher success rate and the higher safety of the operation are ensured.
More specifically, the coil wound by the alloy wire comprises a temperature measuring ring and at least one temperature sensor, wherein the winding interval of the winding interval at the middle position of each section of the coil.
Specifically, the temperature measuring ring shape is designed into a complete ring and a C-shaped ring, the material is 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 0.5-2.5mm.
Preferably, the temperature sensor device is arranged at the unreeling 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. Through the alloy wire isolation of temperature sensor head end and heating coil, can realize more tissue temperature measurement for temperature measurement feedback is more direct, and radio frequency closure is safer.
Specifically, the rubber head is a round rubber head formed by curing epoxy resin glue or UV glue.
Preferably, the main body tube is a multi-layer single-cavity braided tube, the outer layer material is Pebax7233 or PA12, the middle layer is 304 stainless steel wire net-shaped braided, the inner layer material is Pebax or PA12, and the Shore hardness of the PA12 material is 77D. The main body tube is preferably a multi-layer woven net tube, so that the flexibility, hardness and pushing property of the tube body of the catheter are good, the tube body can be bent at a large angle without damage, and the catheter can better pass through a tortuous blood vessel, and is suitable for more complex lesion sites.
In particular, the connection of the heat-generating section to the main body tube is achieved.
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific 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 explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
Example 1
Referring to fig. 1, the radio frequency closure catheter of the present embodiment is provided with a rubber head 1, a heating section 2, a main body tube 3, a stress release tube 5, a handle 6, a wire guide port 7, a connecting cable 8 and a connector 9 in sequence from the distal end to the proximal end, wherein the rubber head 1, the heating section 2 and the main body tube 3 are sequentially arranged from the distal end to the proximal end to form a tube body 4. The stress release tube 5 is sleeved on the proximal end of the main body tube 3, the distal outlet of the handle 6 is fixedly connected with the proximal end of the main body tube 3, and the distal outlet of the handle 6 is also fixedly connected with the proximal end of the stress release tube 5. A 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 supply radio frequency current.
Referring to fig. 2, the heating section 2 includes an inner coil tube 10, two sections of coils formed by winding alloy wires 11, and an insulating outer tube 12; wherein,
the coil inner sleeve 10 is a single-lumen tube, and the surface of the coil inner sleeve is provided with two sections of coils which are formed by winding one alloy wire 11 after being folded in half, and the two sections of coils which are preferably designed in the embodiment 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 120-260cm; the winding start point of the far-end coil is 1-10mm away from the far-end opening of the inner sleeve 10 of the coil, and the distance between the winding start point of the near-end coil and the winding end point of the far-end coil is 0-2mm; in the winding process of each section of coil, a gap of 0-0.15mm is required to be reserved between all alloy wires 11; and, in addition, the processing unit,
the distal coil and the proximal coil are respectively provided with an unwrapped interval with the width of 0.5-3.0mm, and the unwrapped interval is preferably positioned in the middle of each section of coil; and in particular, on the surface of each coil segment where the winding is not spaced, the alloy wire 11 runs along the axial direction of the radiofrequency closure catheter; and, in addition, the processing unit,
the far-end coil or the near-end coil formed by winding the alloy wire 11 is adhered and fixed 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 1.10-1.20mm, preferably 1.30-1.40mm.
Small holes, called round threading holes 14 and 15, are formed in 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 penetrate into the inner cavity of the coil inner sleeve 10 through the round threading holes 14 and 15, respectively, as shown in fig. 2.
In the embodiment shown in fig. 2, the insulating outer sleeve 12 is a single-lumen tube, can be thermally shrunk tightly on the surface of the coil wound by the alloy wire 11, and can be made of one material selected from FEP, PTFE, PET and has a thickness of 0.01-0.2mm.
In addition, as shown in fig. 1 and 2, a wire guide tube 13 is further inserted into the radio frequency closure catheter, one end of the wire guide tube penetrates from the distal end opening of the inner sleeve 10 of the coil, passes through the inner cavity of the main body tube 3 and the inner cavity of the handle 6, and the other end of the wire guide tube is inserted into the distal end inner cavity of the wire guide opening 7, and is connected and communicated with the wire guide opening 7.
As shown in fig. 3, the connection of the coil inner tube 10 to the main body tube 3 is shown. Specifically, the extension lines of the alloy wires 11 are cut off to different lengths respectively at the proximal pipe orifice of the inner sleeve 10 of the coil, all the alloy wires 11 should be at least exposed out of the proximal pipe orifice of the inner sleeve 10 of the coil by 0.5mm, and the proximal ends of all the alloy wires 11 are respectively connected with a copper wire 16 with the length of 100cm by using 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 0.1-0.2mm. 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 0.1-0.15mm. Meanwhile, the inner diameters of the circular threading holes 14 and 15 on the coil inner sleeve 10 are 0.35-0.5mm.
A temperature measuring device can be arranged on the winding inner sleeve 10 at an unreeling interval between a far-end coil and a near-end coil which are formed by winding alloy wires 11. The specific structure and manufacturing method of the temperature measuring device will be described in detail in the following embodiments.
Embodiment one of the temperature measuring device
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 fitted at an intermediate position of the winding-free interval of the coil; the two side edges of the temperature measuring ring 17 are not contacted with the alloy wires 11 of the coil; the cross section openings of the temperature measuring ring 17 are positioned at two sides of a straight section part of the alloy wire 11 axially arranged along the radio frequency closed catheter and are not contacted with the alloy wire 11; the temperature measuring ring 17 is fixed to the surface of the inner sleeve 10 of the coil by means of glue, preferably UV glue or le-tai 4011 glue.
With continued reference to fig. 4, a circular threading hole 19 is formed on the surface of the coil inner sleeve 10 at a clearance 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, an 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 subsequently 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); the head end of the temperature sensor 18 is arranged at the center of the surface of the temperature measuring ring 17, and is adhered and fixed by using UV glue or Lobata 4011 glue.
In the present embodiment, the arrangement of the temperature measuring devices of the remaining coil segments is identical to the above-described example.
Temperature measuring device embodiment II
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 outer shape of the temperature measuring ring 21 is a circular ring (namely a complete ring).
In the present embodiment, as shown in fig. 5, a circular threading hole 20 is formed on the surface of the inner sleeve 10 of the coil at the intermediate position of the winding-free interval of the coil, and the aperture size is 0.15-0.3mm; penetrating an extension line of the temperature sensor 18 from the threading hole 20 into the inner cavity of the coil inner sleeve 10, wherein the extension line is subsequently 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 middle position of the winding-free interval of the coil, and is kept at a distance of 0.5-1.5mm from the circular threading hole 20, and the head end of the temperature sensor 18 is adhered and fixed by using UV glue or Lobata 4011 glue.
With continued reference to fig. 5, the temperature measuring ring 21 is assembled at an intermediate position of the winding-free interval of the coil, the temperature measuring ring 21 should completely cover the temperature sensor 18, and both side edges of the temperature measuring ring 21 are not in contact with the alloy wire 11 of the coil, the temperature measuring ring 21 is fixed using ethylene oxide glue, UV glue or le 4011 glue, and specifically, a gap between the inner sleeve 10 of the coil and the temperature measuring ring 21 is filled with glue to fix the temperature measuring ring 21.
In the present embodiment, the arrangement of the temperature measuring devices of the remaining coil segments is identical to the above-described example.
Third embodiment of the 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 circular (i.e. complete ring).
As shown in fig. 6, the position of the coil is predetermined on the surface of the coil inner sleeve 10, and the temperature measuring ring 31 is fixed on the surface of the coil inner sleeve 10 by using glue at the middle position of the predetermined non-winding interval of the coil, 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); the head end of the temperature sensor 18 is arranged at the middle position of the surface of the temperature measuring ring 31, and keeps a distance of 0.5-1.5mm from the circular threading hole 22, and meanwhile, the head end of the temperature sensor 18 is adhered and fixed by using glue.
Then, winding the alloy wire 11 on the surface of the inner sleeve 10 of the coil from the distal end according to the predetermined coil position until the alloy wire 11 is wound on one side of the distal end of the temperature measuring ring 31, wherein the alloy wire 11 is wound to cover 0.1-0.3mm of the distal end of the temperature measuring ring 31, and fixing the wound alloy wire 11 by using glue; and continuing to wind 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 coil is completed, and penetrating the extension line of the alloy wire 11 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 le tai 4011 glue, preferably le tai 4011 glue.
In the present embodiment, the arrangement of the temperature measuring devices of the remaining coil segments is identical to the above-described example.
Fourth embodiment of the temperature measuring device
Referring to fig. 7, in the present embodiment, each set of temperature measuring devices includes one temperature measuring ring 41 and one temperature sensor 18. In the present embodiment, the temperature measuring ring 41 has an annular shape.
As shown in fig. 7, in this embodiment, a circular threading hole 23 is formed on the surface of the inner sleeve 10 of the coil at the middle position of the winding-free interval of the coil, the aperture size is 0.15-0.3mm, and an extension line of the temperature sensor 18 is threaded from the circular threading hole 23 into the inner cavity of the inner sleeve 10 of the coil, and the extension line is subsequently 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); the head end of the temperature sensor 18 is installed at the middle position of the winding-free interval of the coil, keeps a distance of 0.5-1.5mm from the circular threading hole 23, and is adhered and fixed by using glue.
The temperature measuring ring 41 is penetrated into the middle position of the winding-free interval of the coil from the distal end of the coil outer sleeve 10, the temperature measuring ring 41 should cover the head end of the temperature sensor 18 completely, and the two side edges of the temperature measuring ring 41 should cover the alloy wires 11 with the width of 0.14-0.75 mm; the gap between the coil inner sleeve 10 and the temperature measuring ring 41 is sealed and fixed by glue.
In this embodiment, the glue is ethylene oxide glue, UV glue or clonidine 4011 glue.
In the present embodiment, the arrangement of the temperature measuring device of the remaining coil segments is the same as the above-described example.
Fifth embodiment of the temperature measuring device
Referring to fig. 8, in the present embodiment, each set of temperature measuring devices includes a temperature measuring ring 51 and a temperature sensor 18. In the present embodiment, the temperature measuring ring 51 has an annular shape.
In the present embodiment, as shown in fig. 8, a circular threading hole 24 is formed on the surface of the inner sleeve 10 of the coil at the intermediate position of the winding-free interval of the coil, and the aperture size is 0.15-0.3mm; a circular threading hole 25 is formed in the middle of the surface of the temperature measuring ring 51, and the aperture size is 0.15-0.3mm.
Penetrating the temperature measuring ring 51 from the distal end of the coil outer sleeve 10 to the intermediate position of the winding-free interval of the coil; penetrating an extension line of the temperature sensor 18 into the threading hole 25 and the threading hole 24 into the inner cavity of the coil inner sleeve 10, wherein the extension line is subsequently 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); and the head end of the temperature sensor 18 is arranged on the outer surface of the temperature measuring ring 51; using epoxy resin glue to fill and seal a gap between the coil inner sleeve 10 and the temperature measuring ring 51, and moving the temperature measuring ring 51 to cover alloy wires 11 with the width of 0.14-0.75mm on two side edges of the temperature measuring ring 51; the head end of the temperature sensor 18 is arranged at the middle position of the outer surface of the temperature measuring ring 51 and keeps a distance of 0.5-1.5mm from the threading hole 25, and the head end of the temperature sensor 18 is fixed by using UV glue or Lobata 4011 glue.
In the present embodiment, the temperature measuring device of the remaining coil segments is arranged in the same manner as in the above example.
Embodiment six of the temperature measuring device
In this embodiment, the temperature measuring device has no temperature measuring ring and only includes the temperature sensor 18.
Referring to fig. 9, in this embodiment, a circular threading hole 26 is formed on the surface of the inner sleeve 10 of the coil at the middle position of the winding-free interval of the coil, the aperture size is 0.15-0.3mm, and an extension line of the temperature sensor 18 is threaded into the inner cavity of the inner sleeve 10 of the coil from the threading hole 26, and the extension line is subsequently connected to the connector 9 through the inner cavity of the main body tube 3, the handle 6 and the connecting cable 8 (refer to fig. 1); the head end of the temperature sensor 18 is installed at the middle position of the winding-free interval of the coil, maintains a distance of 0.5-1.5mm from the circular threading hole 26 in the circumferential direction, and fixes the head end of the temperature sensor 18 by using UV glue or Lobata 4011 glue.
In the present embodiment, the temperature measuring device of the remaining coil segments is identical to the above-described example.
In the different embodiments of the radio frequency closed catheter according to the present invention, the arrangement of the temperature measuring device of the different coil sections may be any of the above six embodiments, and is not limited to the same arrangement.
In this embodiment, the material of the temperature measuring ring may be one selected from 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 2.5mm.
In this embodiment, the temperature sensor 18 is a thermocouple, of the K-type, with an extension of 0.12 x 0.24mm in cross-section and a length of 100cm.
As shown in fig. 2, after the winding of the coil is completed and the setting of the temperature measuring device is completed, an 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 shrinking machine to completely wrap the heating section 2, wherein the heat shrinkage temperature is 200-260 ℃. Specifically, the material of the insulating outer sleeve 12 can be FEP (fluoroethylene propylene copolymer), and has transparent color, wall thickness of 0.09-0.11mm and length of 10-15mm, and enlarged inner diameter of > 1.9mm and recovered inner diameter of < 1.3mm.
In this embodiment, the guidewire tube 13 is in the shape of a single lumen tube. When the wire guide tube 13 is installed, one end of the wire guide tube 13 penetrates through the distal end opening of the coil inner sleeve 10, sequentially penetrates through the coil inner sleeve 10, the main body tube 3 and the inner cavity of the handle 6, the distal end of the wire guide tube 13 exposes 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 wire guide tube 13 is inserted into the distal end inner cavity of the wire guide opening 7, the insertion length is 0.3-1.0cm, and the interface is adhered 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 0.8mm.
As shown in fig. 2, the rubber head 1 is located at the most distal end of the radio frequency closed catheter, and is used for enabling the head end of the catheter to be smoother so as to ensure that the movement of the catheter in operation does not damage blood vessels. The material of the glue head 1 is epoxy resin glue or UV glue, specifically, the epoxy resin glue or UV glue is coated on the outer surface of the wire guide tube 13 layer by layer and cured to form the glue head 1, and the glue head 1 is basically spherical in shape, and has an outer diameter of 1.5-2.33mm, preferably 1.7-2.1mm.
Referring to fig. 3, extension lines of all copper wires 16 and temperature sensors 18 are inserted into the inner cavity of the main body tube 3, epoxy resin glue is coated on the surface of the length of the proximal end 5-10mm of the inner sleeve 10 of the coil, and the glued part of the inner sleeve 10 of the coil is embedded into the inner cavity of the main body tube 3 to bond the inner sleeve 10 of the coil and the main body tube 3. The main body tube 3 is a multi-layer single-cavity braided tube, the outer layer material is Pebax7233 or PA12, the middle layer is 304 stainless steel wire net-shaped braided, the inner layer material is Pebax7233 or PA12, the shore hardness of the used PA12 material is 77D, the inner diameter of the main body tube is 1.20-1.80mm, and the outer diameter is 1.65-2.25mm.
Referring to fig. 1, a stress release tube 5 is sleeved on the proximal end of a main body tube 3, an alloy wire 11 and an extension line of a temperature sensor 18 are opened on the proximal end of the main body tube 3, the extension lines of all the alloy wires 11 and the temperature sensor 18 are welded on a circuit board inside a handle 6 by using soldering, one end of a connecting cable 8 is also welded on the circuit board by using soldering, the other end of the connecting cable 8 is welded on a connector 9 by using soldering, the proximal end of the main body tube 3 is adhered and fixed to a distal outlet of the handle 6 by using a le 4011 glue, and the proximal end of the stress release tube 5 and the distal outlet of the handle 6 are adhered and fixed by using a le 4011 glue.
Specifically, for example, the stress relief tube 5 is made of silicon rubber, is in the shape of a cylinder with a cavity, and has a length of 3-10cm; the handle 6 is made of PC+ABS resin and is made by adopting an injection molding process, and the shape of the handle can be the shape of a handle of a conventional interventional instrument; the connector 9 is a standard, for example, a REDEL12 pin plastic connector from Lei Mo (Shanghai) trade company Limited may be used.
The invention has the following advantages:
1. the radio frequency closed catheter provided by the invention can realize radio frequency ablation of two pathological change positions of lower limb shallow varicose veins and transit varicose veins under the condition of no need of replacement of instruments by arranging the far-end coil and the near-end coil and preferably selecting the two coils to be designed with different widths, wherein the far-end coil with a short width is independently used for treating the transit varicose veins, and the far-end coil and the near-end coil are jointly used for treating the lower limb shallow varicose veins;
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, temperature measurement feedback is more direct, and radio frequency ablation is safer;
3. according to the radio frequency closed catheter and the corresponding manufacturing method, the temperature measuring device is arranged at the middle part of at least one section of coil, more preferably, the temperature measuring device is arranged at the middle part of each section of coil, and particularly the radio frequency closed catheter comprises a temperature measuring ring and a temperature sensor;
4. the main body tube of the radio frequency closure catheter adopts the multi-layer woven mesh tube, so that the radio frequency closure catheter is good in flexibility, hardness and pushing property, and the catheter body can be bent at a large angle without damage, so that the radio frequency closure catheter can better pass through tortuous vessels, and is suitable for more complex lesion sites.
Finally, it should be noted that: the above examples and embodiments are only for illustrating the technical solution of the present invention, but not for limiting the same; although the 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 scheme described in the foregoing embodiments and implementations can be modified or some or all of the technical features thereof can be replaced with equivalents; such modifications and substitutions do not depart from the essence of the corresponding technical solutions from the scope of the embodiments and implementation solutions of the present invention. The invention is limited only by the claims and the full scope and equivalents thereof.
Claims (5)
1. A radio frequency occlusive catheter for treating varicose veins of a lower limb, comprising: the device comprises a rubber head, a heating section, a main body tube, a stress release tube, a handle and a guide wire port which are sequentially arranged from a far end to a near end;
the heating section comprises a coil inner sleeve, two sections of coils and an insulating outer sleeve; the surface of the inner sleeve of the coil is wound with a coil formed by winding two sections of alloy wires respectively;
the two sections of coils are respectively arranged at the proximal end and the distal end of the inner sleeve of the coil and are a distal coil and a proximal coil, the distal coil and the proximal coil are designed with different widths, the distal coil is independently used for a traffic vein, and the distal coil and the proximal coil are jointly used for a lower limb shallow vein; the two sections of coils are formed by winding two sections of alloy wires on the surface of an inner sleeve of the coil respectively; wherein the far-end coil and the near-end coil are both partially wound on the surface of the inner sleeve of the coil, and the far-end coil and the near-end coil are both provided with an unreeled interval on the surface of the inner sleeve of the coil, the two unreeled intervals are respectively positioned at the middle positions of the near-end coil and the far-end coil, and the trend of the alloy wires of the far-end coil and the near-end coil on the surface of the unreeled interval of the inner sleeve of the coil is along the axial direction of the radio-frequency closed catheter; the gap between the alloy wires is 0mm, and the length of the unwrapped interval is 0.5mm-3.0mm;
a near-end circular threading hole and a far-end circular threading hole are respectively formed in the coil winding terminal positions of the near end and the far end of the surface of the coil inner sleeve, and the extension lines of the near-end coil and the far-end coil penetrate into the inner cavity of the coil inner sleeve through the near-end circular threading hole and the far-end circular threading hole respectively;
the surface of the inner sleeve of the coil is also sleeved with a temperature measuring ring, and the temperature measuring ring is arranged in the middle position of the unreeling interval; when the temperature measuring ring is a split ring, the cross section opening of the temperature measuring ring is positioned at two sides of a straight section part of the far-end coil and the near-end coil which are axially arranged along the radio frequency closed catheter, and when the temperature measuring ring is a closed ring, a perforation or no perforation is arranged in the middle of the temperature measuring ring, so that an extension line of a temperature sensor passes through the perforation or does not pass through the perforation, and the temperature sensor can be positioned above or below the temperature measuring ring; and, the both side edges of the temperature measuring ring are not contacted with the distal coil and the proximal coil;
the inside of the radio frequency closed catheter is also penetrated with a wire guide tube, one end of the wire guide tube penetrates from the distal end opening of the coil inner sleeve tube, passes through the inner cavity of the main body tube and the inner cavity of the handle, and the other end of the wire guide tube is inserted into the distal end inner cavity of the wire guide port, and is mutually connected and communicated with the wire guide port.
2. The radio frequency occlusive catheter for treating varicose veins of a lower limb according to claim 1, wherein the temperature sensor and the temperature measuring ring are configured to measure the temperature of an inner wall of a mammalian lumen.
3. The radio frequency occlusive catheter for treating varicose veins of the lower limb according to claim 1, wherein the distal coil or proximal coil is configured from a single wire of alloy folded in half at a medial location and disposed on the inner sleeve of the coil starting at the point of folding.
4. The radio frequency occlusive catheter for treating varicose veins of the lower limb according to claim 1, wherein circular holes are formed in the surface of the inner sleeve of the coil at the clearance positions of the temperature measuring ring and the distal coil, and the temperature measuring ring and the proximal side of the proximal coil, the aperture size of the circular holes is 0.15-0.3mm, and the extension line of the temperature sensor penetrates the inner cavity of the inner sleeve of the coil from the circular holes.
5. The radio frequency occlusive catheter for treating varicose veins of a lower limb according to claim 1, wherein the temperature measuring ring is made of a material selected from one of platinum iridium alloy, platinum gold, stainless steel, and has an inner diameter ranging from 1.3mm to 2.0mm, an outer diameter ranging from 1.4 mm to 2.1mm, and a width ranging from 0.5mm to 2.5mm.
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CN112294430B (en) * | 2020-09-17 | 2022-05-13 | 杭州堃博生物科技有限公司 | Radio frequency ablation catheter and preparation method thereof |
CN112957119A (en) * | 2021-01-29 | 2021-06-15 | 丁兆霖 | Multi-joint functional negative plate connecting wire |
CN114010305B (en) * | 2021-11-17 | 2022-12-02 | 上海玮琅医疗科技有限公司 | Radio frequency ablation catheter and system |
CN115381548B (en) * | 2022-08-01 | 2023-09-19 | 上海玮琅医疗科技有限公司 | Radio frequency ablation catheter capable of locking connection tail wire |
CN116570363B (en) * | 2023-07-14 | 2024-04-02 | 北京先瑞达医疗科技有限公司 | Radio frequency catheter |
CN116570362B (en) * | 2023-07-14 | 2024-02-02 | 北京先瑞达医疗科技有限公司 | Radio frequency catheter control system and method |
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