CN106963486B

CN106963486B - Esophagus reflux radio frequency ablation electrode

Info

Publication number: CN106963486B
Application number: CN201710361281.7A
Authority: CN
Inventors: 王新; 王洪奎
Original assignee: Individual
Current assignee: Weihai Hongyuan Medical Technology Co ltd
Priority date: 2017-05-20
Filing date: 2017-05-20
Publication date: 2021-01-12
Anticipated expiration: 2037-05-20
Also published as: CN106963486A

Abstract

An esophagus reflux radio frequency ablation electrode comprises an electrode bundle (1), an electrode cap (2), an electrode base (3), a central pull rod (4), a catheter (5), a handle (6), a knob (7), a cable (8), a plug (9), a water injection nozzle (10), a water injection pipe (11) and a hose (12). The electrode bundle (1) can be opened to form an olive shape, a conductive area is arranged at the maximum diameter position of the section of the olive shape, and insulating layers are arranged at other parts of the esophagus reflux radio frequency ablation electrode. The electrode bundle (1) is made of conductive metal capillaries which are divided into a plurality of groups, and at least one capillary in each group is used for cooling liquid to flow through. The electrode can conveniently and accurately carry out radiofrequency ablation treatment and cooling on the esophagus annular region, and meanwhile, because the electrode bundle is of an olive-shaped structure, cooling liquid can easily flow into the stomach, so that the risk that the cooling liquid flows out of the esophagus to the pharynx and is sucked into the trachea when the balloon is used is avoided.

Description

Esophagus reflux radio frequency ablation electrode

Technical Field

The invention relates to an esophagus reflux radio frequency ablation electrode, in particular to a radio frequency ablation electrode which can be matched with an endoscope to treat esophagus reflux.

Background

Gastroesophageal reflux disease (GERD), which is a generic term for gastroesophageal reflux disease and esophageal mucosa injury disease caused by excessive contact (or exposure) of the gastroesophageal lumen with gastric juice; refers to a disease in which the contents of the stomach and duodenum reversely flow into the esophagus to cause clinical symptoms and/or esophageal inflammation. The regurgitation mainly comprises gastric acid and pepsin, and can also comprise duodenal fluid, cholic acid, pancreatic juice and the like, wherein the former is clinically common, and the latter is mainly after gastrectomy, gastrointestinal anastomosis and esophagogastrointestinal anastomosis. The occurrence of gastroesophageal reflux and its complications is multifactorial, including defects in the oesophageal intrinsic antireflux mechanism, such as lower oesophageal sphincter dysfunction and oesophageal body movement abnormalities; there are also functional disorders due to mechanical factors outside the esophagus.

Patients with GERD are physiologically and pathologically characterized by pathological gastroesophageal reflux, which causes discomfort and vomiting in mild cases and esophagitis and pulmonary aspiration syndrome, even asphyxia death in severe cases.

Gastroesophageal reflux disease can seriously affect the quality of life of a patient. In recent years, gastroesophageal reflux disease in Asia-Pacific region has a remarkable rising trend. Gastroesophageal reflux disease is quite common in western countries, about 7% -15% of people have gastroesophageal reflux symptoms, the incidence of diseases increases with the increasing age, the peak incidence age is 40-60 years old, the incidence of diseases of men and women is not different, and most reports suggest that the number of patients with reflux esophagitis is obviously more than that of women in male patients. The survey shows that the ratio of the incidence rates of the male and the female is 2.4: 1. compared with the western countries, the gastroesophageal reflux disease has lower morbidity and lighter illness state in China.

Inflammatory diseases such as esophageal mucosa erosion, ulcer and the like under the endoscope of about half of gastroesophageal reflux patients are called reflux esophagitis; however, a considerable proportion of patients with gastroesophageal reflux disease have no reflux esophagitis under their endoscope, and this type of gastroesophageal reflux disease is called endoscope-negative gastroesophageal reflux disease.

Currently there are three main treatment modalities for GERD: (1) drug therapy is the primary treatment for GERD, but it is difficult to maintain long-term efficacy; (2) the fundoplication is a traumatic operation, and some patients are complicated by dysphagia or abdominal distension; (3) the radio frequency treatment of the sphincter at the lower end of the esophagus is minimally invasive treatment under an endoscope, and a large number of clinical tests prove that the curative effect is particularly satisfactory in long-term curative effect.

Currently used for clinical applications is the introduction of the Stretta instrument manufactured by curyroin Medical, Inc, usa, which measures the distance of the tooth line from the incisor teeth by means of an endoscope. The Stretta guide wire is introduced into the duodenum through the biopsy channel of the gastroscope, the gastroscope is withdrawn, the Stretta catheter is introduced into the esophagus along the guide wire, and the guide wire is withdrawn. Injecting gas into the air bag at the front end of the dilatation catheter to a proper pressure by using an injector to inject the air bag to push an excitation device at the tail end of the Stretta catheter so as to enable 4 electrode needles on the outer basket of the air bag to be inserted into the muscular layer of the esophageal wall and rapidly reduce the screen display resistance of the Stretta system at 1cm, 0.5cm above the dentate line and 0.5cm below the dentate line respectively. After confirming that the resistance and the temperature are normal, starting treatment once for 60 seconds, and treating each part at 0 degrees and 45 degrees in a right-handed way twice; then the catheter air sac is pushed into the stomach, 25ml and 22ml of air are respectively injected into the air sac, then the catheter is pulled outwards to a proper resistance position, and each plane is respectively treated for three times at 0 degree, right-handed 30 degree and left-handed 30 degree. In some cases, 2 treatment planes are added on the dentate line by 1.5cm and 2cm, and the treatment is performed on 6-8 planes and 56-72 points. In the treatment process, the tissue resistance is not more than 1000 ohm, the temperature of the muscular layer is 80-90 ℃, and the temperature of the mucous membrane surface is not more than 50 ℃. The mucous membrane surface is cooled and protected by a precooling water flushing system. If the temperature or resistance exceeds the normal range, the treatment is automatically stopped.

The radio frequency ablation electrode needle in clinical application at present adopts an air bag to insert the electrode needle into tissue to be treated by radio frequency ablation, the esophagus is blocked while the treatment is carried out, and the cooling water in the esophagus is cooled by adopting a flushing mode, so that the cooling water in the esophagus can flow out to the pharynx, and the risk of being sucked into the trachea by a patient is caused.

Disclosure of Invention

In view of the above problems in the prior art, it is an object of the present invention to provide an olive-shaped rf ablation electrode capable of being used with an endoscope, which has a flexible, elongated catheter, and the length of the catheter remains unchanged during the deployment or retraction of the olive-shaped electrode needle.

The technical scheme of the invention is as follows.

The utility model provides an esophagus palirrhea radio frequency ablation electrode, includes electrode bundle, electrode cap, electrode holder, pipe, wherein:

the electrode bundle can be expanded into an olive shape, and a conductive area is arranged at the position of the maximum diameter of the section of the olive shape;

insulating coatings are arranged on the other parts of the olive shape, the electrode cap, the electrode seat and the outer surface of the catheter;

the electrode bundle is made of conductive metal capillaries which are divided into a plurality of groups; at least one of the metal capillaries in each group is used for cooling liquid to flow through.

Preferably, the number of the metal capillaries is 2-3 per group.

Preferably, the metal capillary has a rectangular cross section.

Preferably, at least one of the metal capillaries in each group has a temperature thermocouple in the uncoated portion of the capillary and is not used for flowing cooling liquid, and a lead wire of the temperature thermocouple is connected to the plug through a cable.

Preferably, the cooling liquid can flow out through the liquid injection nozzle, the liquid injection pipe, the electrode holder, the electrode bundle, the electrode cap and the hose.

Preferably, the device further comprises a central pull rod; the electrode bundle comprises a distal end positioned at one side of the electrode cap and a proximal end close to the catheter; the far end of the electrode bundle is connected with the electrode cap and the far end of the central pull rod, and the near end of the electrode bundle is connected with the far end of the catheter; the central pull rod can slide in the center of the electrode holder and the catheter, so that the distal end of the central pull rod moves towards the distal end of the catheter.

Preferably, the proximal end of the central pull rod is connected to the distal end of a central metal tube within the catheter; the near end of the central metal tube is connected with a first bolt in the handle; the first bolt is matched with a first nut fixedly connected with a first bevel gear, and the second bevel gear is connected with the knob and meshed with the first bevel gear.

Preferably, the first bolt and the first nut are engaged by a self-lockable thread.

Preferably, the length of the conduit is 60-120 cm.

Preferably, the diameter of the conduit is no greater than 2.8mm in the fore and aft.

Through the technical scheme, the invention can obtain the following technical effects.

Through the technical scheme, the radio frequency ablation electrode for the gastroesophageal esophagus can conveniently and accurately carry out radio frequency ablation treatment on the esophagus annular region, the temperature thermocouple is arranged at the middle point of the capillary tube of the electrode bundle of the olive-shaped electrode, the ablation temperature can be monitored and controlled in real time, and cooling liquid is injected into the metal capillary tube for cooling to cool the electrode when necessary. Meanwhile, because the electrode bundle is of an olive-shaped structure, cold water for cooling can easily flow into the stomach, so that the risk of water choking caused by the fact that the cooling liquid flows out from the esophagus to the pharynx when the balloon is used is avoided. In addition, because the olive-shaped structure can enable the ablated tissue to be always exposed during the treatment, an operator can easily observe the progress of the ablation treatment during the treatment and perform other treatment operations such as irrigation through a gastroscope.

Drawings

Fig. 1 is a schematic diagram of the overall structure of the esophageal reflux radio frequency ablation electrode of the invention.

FIG. 2 is a cross-sectional view of a distal portion of the esophageal reflux radio frequency ablation electrode of the present invention.

FIG. 3 is a schematic view of the handle portion of the esophageal reflux radio frequency ablation electrode of the present invention.

Detailed Description

The term "radiofrequency ablation" as used herein refers to thermal injury in which a radiofrequency current of a frequency up to a certain value (> 100 kHz) is applied to the tissue of a living body, causing the movement of charged ions within the tissue to produce a thermal effect, heating the tissue to a target temperature (e.g. 60-100 ℃), thus causing necrosis of the tissue or cells.

As shown in the attached figure 1, the esophagus reflux radio frequency ablation electrode comprises an electrode bundle 1, an electrode cap 2, an electrode base 3, a central pull rod 4, a catheter 5, a handle 6, a knob 7, a cable 8, a plug 9, a water injection nozzle 10, a water injection pipe 11 and a hose 12.

The electrode bundle 1 can be expanded into an olive shape, a small section of the olive shape with the largest diameter has no insulating coating, and other parts including the electrode cap 2, the electrode seat 3 and the catheter have insulating layers;

the electrode bundle 1 is made of a group of conductive metal capillaries, the metal capillaries are divided into a plurality of groups, each group is 2-3, and one of the groups is internally provided with a temperature thermocouple at the position without a coating;

in one embodiment, the electrode bundle 1 is constructed and arranged for delivering radiofrequency energy to an electrode structure of the tissue to be treated. The electrode bundle 1 is composed of a plurality of conductive metal capillaries. The wires are substantially uniformly arranged on the sides of the cylinder and are substantially parallel to the axis of the cylinder, whereby radiofrequency energy can be delivered substantially uniformly to the tissue to be treated at an appropriate intensity to effect ablation of, or cause damage to, mucosal or submucosal tissue. Typically, ablation in this embodiment is used to create some thermal damage to the mucosa in the target tissue. When using this method, thermal damage to the target tissue from ablation can be recovered in a period of 2 to 3 days.

Typically, the RF energy is applied to the tissue being treated in a bipolar fashion from the electrode bundle.

In one embodiment, the metal capillaries of the electrode bundle 1 include a positive electrode group and a negative electrode group, and the two metal capillaries are arranged alternately to form the olive shape.

The metal capillary tube of the positive electrode group is connected with the positive electrode of the radio frequency ablation energy source, and the metal capillary tube of the negative electrode group is connected with the negative electrode of the radio frequency ablation energy source. Generally, to provide radiofrequency ablation energy to the metal capillary, a single or multiple metal capillaries can be used to provide radiofrequency ablation energy of a particular power.

It will be appreciated by those skilled in the art that although in the above embodiments the radiofrequency energy is delivered to the ablated tissue through metal capillaries connected to positive and negative electrodes respectively, the invention is not so limited. In other embodiments of the present invention, the RF energy may be transmitted in a variety of ways. Alternatively, the radiofrequency energy may also comprise a monopolar electrode configuration, the electrode bundle of which is energized in combination with a return electrode, which is typically placed on the patient's skin.

The cooling liquid can flow out from the electrode cap 2 and the hose 12 through the liquid injection nozzle 10, the liquid injection pipe 11, the handle 6, the conduit 5, the electrode holder 3 and the cooling metal capillary in the electrode bundle 1.

The far end of the central pull rod is connected with the bolt and can be self-locked through the nut.

The electrode cap 2 is disposed on the distal side of the electrode bundle 1, thereby establishing electrical connection of the metal capillary tube with a radio frequency energy source. The electrode cap 2 may be made of a material suitable for delivering radiofrequency ablation energy and suitable for contact with human tissue, as desired.

The electrode holder 3 is arranged at the proximal side of the electrode bundle 1, and the electrode holder 3 is suitable for penetrating out of a tool passage of a used gastroscope. The distal side of the electrode holder 3 is in mechanical connection with the proximal side of the electrode bundle 1, and the proximal side of the electrode holder 3 is operatively connectable with the insertion end of a gastroscope. The electrode holder 3 may be provided in different sizes according to the size of the insertion end of the gastroscope.

In one embodiment, the electrode holder 3 is substantially tubular in shape, with one end fixedly connected to the proximal side of the electrode bundle 1 and the other end having an inner diameter adapted to detachably connect to the outer diameter of the distal end of the gastroscope used.

The electrode holder 3 may be made of any material suitable for use with the insertion end of a gastroscope. In a preferred embodiment, the electrode holder 3 can be made of a biocompatible polymer material, such as medical polyurethane plastic.

The central pull rod 4 is slidable in the center of the electrode holder 3 and the catheter 5 such that the distal end of the central pull rod 4 is moved towards the distal end of the catheter 5.

The electrode bundle 1 comprises a distal end located at one side of the electrode cap 2, and a proximal end close to the catheter 5; the far end of the electrode bundle 1 is connected with the far ends of the electrode cap 2 and the central pull rod 4, and the near end of the electrode bundle 1 is connected with the far end of the catheter 5.

The catheter 5 is a flexible, elongated hose having a diameter no greater than 2.8mm plus or minus, so that it can be passed through the working lumens of various endoscopes to the site of a lesion.

In one embodiment, the hose has a length of 60-120 cm.

Figure 2 shows a cross-sectional view of a distal portion of an esophageal reflux radio frequency ablation electrode made in accordance with the present invention. The olive-shaped electrode bundle 1 is composed of a plurality of metal capillaries, and the metal capillaries are divided into a plurality of groups. Each group of the metal capillary tubes is 2-3, one of the metal capillary tubes in each group is provided with a temperature thermocouple 10 in the tube without a coating, and the melting temperature can be monitored and controlled in real time.

The central metal tube 13 is used for driving the electrode bundle 1 to open and retract; the distal end of the central metal tube 13 is connected to the proximal end of the central pull rod 4, and the proximal end is connected to a nut 15 in the handle 6.

In the area A, the electrode bundle 1 is fixed with the central pull rod 4 and the electrode cap 2; the lead wires of the thermocouples 15 of the electrode bundle are connected to the plug 9 through the central pull rod 4, the inner cavity of the central metal tube 13, the cable connecting wire 17 and the cable 8.

Except for the maximum diameter of the olive, i.e. the middle section (area B) of the electrode bundle 1 without the insulating coating, the other parts of the esophagus reflux radio frequency ablation electrode are provided with insulating layers;

the injection metal capillary 14 is connected with the central pull rod 4 in the area C, and liquid flows out from the top of the electrode cap 2 through the injection metal capillary 14 and the central pull rod 4.

In one embodiment, the gastroscope is selected from conventional endoscopes currently available on the market, such as the "gastroscope" which employs an electronic camera. Although the specific construction of commercially available endoscopes varies, as shown in fig. 2, most endoscopes include an elongated body extending along an axis and having a controllable insertion end (distal end) and an operative end (proximal end) including a video channel for connection to a display screen and a port providing access to an internal working channel within the body. As is common in the endoscopic art, a dial, lever or other mechanism (not shown) is typically provided on the handle at the operating end for the operator to selectively control the distal end of the endoscope.

In use, an ablation instrument including an ablation structure is advanced into the alimentary tract while supported by the distal end of the endoscope. The ablation structure is deflectable toward the tissue surface and a radio frequency signal can be applied to ablate the tissue surface. Within the alimentary tract, various sized tissue surface sites can be selectively ablated using the present device.

Figure 3 shows a structural view of the handle of the esophageal reflux radio frequency ablation electrode.

The proximal end of the central pull rod 4 is connected with the distal end of a central metal tube in the catheter 5; the near end of the central metal tube is connected with a bolt in the handle 6; the bolt is matched with a nut fixedly connected with a first bevel gear, and a second bevel gear is connected with the knob 7 and meshed with the first bevel gear.

In a preferred embodiment, the bolt and the nut are engaged by a self-locking thread.

As the length of the catheter of the esophageal reflux radio frequency ablation electrode is usually 60-120cm, and the working cavity of the endoscope is bent, the resistance is large when the olive-shaped electrode needle is unfolded or retracted. The olive electrode needle is deployed or retracted from within the needle tip at the distal end of a flexible, elongate catheter. When the olive-shaped electrode needle starts to be unfolded, the catheter is subjected to tension force due to the friction force between the tip of the olive-shaped electrode needle and the inner wall of the needle point; when the olive-shaped electrode needle begins to be withdrawn, the catheter is subjected to compressive forces, and these tensile forces or compressive forces cause the catheter to change in length, which may cause the electrode needle to fail to be fully deployed or withdrawn. It is therefore desirable that the length of the catheter be maintained during deployment or retraction of the olive electrode needle.

The proximal end of the catheter 5 in fig. 3 is fixedly connected with the handle 6, and the structure can ensure that the length of the flexible and slender catheter 5 is kept unchanged when the flexible and slender catheter 5 is subjected to tension or pressure, and meanwhile, the olive-shaped electrode needle has small resistance to unfolding and retracting and has large driving force.

It will be understood by those skilled in the art that various modifications and changes may be made to the embodiments disclosed above without departing from the spirit of the invention, and these modifications and changes are intended to fall within the scope of the invention, which is defined in the appended claims.

Claims

1. An esophageal reflux radio frequency ablation electrode which can penetrate out of a tool channel of a gastroscope and comprises an electrode bundle (1), an electrode cap (2), an electrode seat (3) and a catheter (5), wherein:

the electrode bundle (1) can be expanded into an olive shape, and a conductive area is arranged at the position of the maximum diameter of the section of the olive shape;

insulating coatings are arranged on the other parts of the olive shape, the outer surfaces of the electrode cap (2), the electrode seat (3) and the catheter (5);

the electrode bundle (1) is made of conductive metal capillaries, and the metal capillaries are divided into a plurality of groups; at least one metal capillary in each group is used for cooling liquid to flow through; the electrode bundle (1) expanded into the olive shape is capable of allowing the cooling liquid to flow into the stomach;

the metal capillary tubes of the electrode bundle (1) comprise a positive electrode group and a negative electrode group, and the two groups of metal capillary tubes are arranged at intervals to form the olive shape;

the electrode holder (3) is basically in a round tube shape and is arranged at the proximal end side of the electrode bundle (1); the electrode seat (3) and the catheter (5) are suitable for penetrating out of a tool channel of a used gastroscope;

the length of the conduit (5) is 60-120cm, and the diameter of the conduit (5) is not more than 2.8 mm;

at least one of the metal capillary tubes in each group is provided with a temperature thermocouple in the tube without a coating and is not used for cooling liquid to flow through, and the lead of the temperature thermocouple is connected to a plug (9) through a cable (8);

the esophagus reflux radio frequency ablation electrode also comprises an injection nozzle (10), an injection pipe (11) and a hose (12), and cooling liquid can flow out through the injection nozzle (10), the injection pipe (11), the electrode holder (3), the metal capillary tube for cooling in the electrode bundle (1), the electrode cap (2) and the hose (12);

the esophagus reflux radio frequency ablation electrode also comprises a central pull rod (4); the electrode bundle (1) comprises a distal end located at one side of the electrode cap (2) and a proximal end close to the catheter (5); the far end of the electrode bundle (1) is connected with the electrode cap (2) and the far end of the central pull rod (4), and the near end of the electrode bundle (1) is connected with the far end of the catheter (5); the central pull rod (4) can slide in the center of the electrode holder (3) and the catheter (5), so that the distal end of the central pull rod (4) moves towards the distal end of the catheter (5).

2. The RF ablation electrode according to claim 1, wherein the number of metal capillaries is 2-3 per group.

3. The esophageal reflux radio frequency ablation electrode of claim 1, wherein the metal capillary is rectangular in cross-section.

4. The esophageal reflux radio frequency ablation electrode according to claim 1, characterized in that the proximal end of the central pull rod (4) is connected to the distal end of a central metal tube inside the catheter (5); the near end of the central metal tube is connected with a screw rod in the handle (6); the screw rod is matched with a nut fixedly connected with a first bevel gear, and a second bevel gear is connected with a knob (7) and meshed with the first bevel gear.

5. The RF ablation electrode according to claim 4, wherein the screw is engaged with the nut by a self-locking thread.