Radio frequency steam ablation catheter for radio frequency steam ablation system and manufacturing method of radio frequency steam ablation catheter

Abstract

The invention provides a radio frequency steam ablation catheter for a radio frequency steam ablation system and a manufacturing method of the radio frequency steam ablation catheter, and relates to the technical field of medical health. A catheter cavity of the radio frequency steam ablation catheter comprises a balloon filling cavity, a saline water cavity, a wire cavity and an exhaust hole; wherein the balloon filling cavity is communicated with the balloon at the far end of the catheter, and the balloon is filled with gas; the saline cavity is used for conveying saline to the far end of the catheter; meanwhile, the saline cavity is provided with an electrode at the far end of the catheter so as to heat the saline to generate steam; a wire passes through the wire cavity, so that the wire is connected to an electrode in the saline water cavity; and the exhaust holes are formed between the balloons, are communicated with the saline water cavity and are used for spraying steam. According to the invention, the endoscopic treatment surgery of weight reduction and metabolism can be more minimally invasive, and the technical effects of simplicity and quickness in operation, safety and reliability, uniform ablation of the mucosa on the inner surface of the duodenum and cooperative use of fewer other instruments are achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical health, and particularly to a radiofrequency steam ablation catheter for a radiofrequency steam ablation system and a manufacturing method thereof. BACKGROUND

[0002] Diabetes is an old medical disease, and more than 90% of it is type 2 diabetes. Type 2 diabetes patients often have overweight and obesity, and obesity further increases the risk of cardiovascular disease in type 2 diabetes patients. At present, type 2 diabetes cannot be cured, but only can be relieved. The treatment methods include diet control, exercise, oral hypoglycemic drugs, and insulin injection therapy. Strict diet control and repeated blood glucose level fluctuations will cause continuous mental stress to patients and affect the quality of life.

[0003] Traditional bariatric surgery effectively reduces body weight and effectively improves blood glucose metabolism disorders in most patients, so that diabetes is clinically relieved or even completely relieved. Therefore, bariatric surgery is renamed weight loss and metabolic surgery. However, surgical trauma is large, which limits its application range and indications.

[0004] In order to minimize the risks related to the invasiveness of weight loss and metabolic surgery, while trying to maintain its good metabolic effects, endoscopic treatment methods that mimic weight loss and metabolism are introduced. Weight loss and metabolic endoscopic treatment includes various instruments: gastric internal folding and suturing instruments, intravascular endoluminal sympathetic nerve radiofrequency ablation instruments, implantable gastric electrical stimulation instruments, suction therapy instruments, gastric balloons, digestive tract bypass liners, and duodenal mucosal surface reconstruction (DMR) instruments; they all have their own advantages, but also have their own limitations.

[0005] Duodenal mucosal surface reconstruction (DMR) instrument is the latest instrument for treating severe obesity and diabetes. It uses limited heat energy carried by steam to perform limited super-micro-invasive ablation on the duodenal mucosa; at the same time, steam naturally has a diffusion effect, which can achieve uniform ablation on the wrinkled duodenal mucosal surface. After ablation, it is repaired and reconstructed by itself, the mucosa is thinned, and the local duodenal signal production is changed, which has a beneficial effect on the liver and metabolism. However, the duodenal mucosal surface reconstruction (DMR) instrument generates steam in the external host computer, and there will be energy loss when it is delivered to the target tissue in the body. This energy loss is influenced by many variables, including heating power, steam flow rate, pressure, catheter length, catheter inner and outer diameter, catheter heat dissipation performance, etc. It is difficult to accurately control the heat actually reaching the target tissue and the temperature of the target tissue, and it is also not convenient to feedback control or monitor the physiological effects of ablation, which can only be calculated by preoperative planning. In addition, the catheter surface will also generate high temperature. All the above means low safety and low reliability. SUMMARY

[0006] One of the purposes of the present application is to provide a radio frequency steam ablation catheter, which can inflate the duodenum by a balloon, and generate instant steam by heating saline, and then spray the hot steam on the mucosa of the inner surface of the inflated duodenum at the catheter head end, so as to effectively achieve the treatment purpose of ablation.

[0007] The second purpose of the present application is to provide a manufacturing method of the radio frequency steam ablation catheter, which is simple in process, easy to operate and high in success rate.

[0008] The third purpose of the present application is to provide a radio frequency steam ablation system, which can make the endoscopic treatment operation of weight loss and metabolism more minimally invasive, and achieve the technical effects of simple and rapid operation, safety and reliability, uniform ablation of the inner surface mucosa of the duodenum, and cooperation with less other instruments.

[0009] The radio frequency steam ablation catheter is used in cooperation with the radio frequency steam ablation system. The radio frequency steam ablation catheter delivers saline and radio frequency electric energy to the catheter head end to generate steam at the catheter head end. While having the advantages of limited super-minimally invasive ablation and uniform ablation, there is no energy loss, the heat of the target tissue in the body can be accurately controlled, the feedback control or monitoring of the physiological effect of ablation is facilitated, no preoperative planning is required, there is no high temperature risk on the surface of the catheter, and higher safety and higher reliability are achieved.

[0010] In order to achieve the above purposes of the present application, the following technical solutions are adopted:

[0011] In a first aspect, a radio frequency steam ablation catheter, the lumen of the radio frequency steam ablation catheter includes a balloon inflation cavity, a saline cavity, a wire cavity and an exhaust hole;

[0012] The balloon inflation cavity is communicated with the balloon at the distal end of the catheter, and the balloon is inflated by gas;

[0013] The saline cavity is used to deliver saline to the distal end of the catheter;

[0014] The saline cavity is provided with an electrode at the distal end of the catheter to heat the saline to generate steam;

[0015] The wire cavity is used to pass through a wire to connect the wire to the electrode in the saline cavity;

[0016] The exhaust hole is arranged between the balloons and communicated with the saline cavity, and is used to spray out steam.

[0017] Further, the number of the balloons is at least two;

[0018] Preferably, the number of the balloons is two.

[0019] Further, the distance between the balloons is 1cm-10cm.

[0020] Preferably, the balloon is a non-compliant balloon.

[0021] Preferably, the shape of the balloon is approximately spherical and / or spindle shape.

[0022] Further, the electrodes in the saline lumen include corrugated electrodes.

[0023] Preferably, the electrodes in the saline lumen are spaced apart without contact.

[0024] Further, the number of the wire lumens is two.

[0025] Further, the number of the rows of the air vent holes arranged along the catheter axis is at least two.

[0026] Preferably, the number of the air vent holes in each row is at least three.

[0027] In the second aspect, a manufacturing method of the radiofrequency steam ablation catheter is provided, comprising the following steps:

[0028] After cutting the pipeline, the balloon connecting hole and the air vent hole are opened at the distal end of the pipeline, the balloon is connected to the pipeline, then the wire is passed through the pipeline, the electrode is welded to the head end of the wire, the electrode is inserted into the saline lumen, then the air vent section pipeline is connected, the head end of the pipeline is made into a circular arc shape, finally, the saline lumen, the wire and the balloon inflation lumen are led out at the proximal end of the catheter, and the radiofrequency steam ablation catheter is obtained.

[0029] Further, the manufacturing method further comprises the following steps:

[0030] At the proximal end of the catheter, the balloon inflation lumen is led out through the luer connector and the single lumen catheter.

[0031] In the third aspect, a radiofrequency steam ablation system is provided, comprising the radiofrequency steam ablation catheter.

[0032] Further, the host of the radiofrequency steam ablation system comprises a microprocessor, a radiofrequency generator and a saline perfusion pump.

[0033] Compared with the prior art, the present application has at least the following beneficial effects:

[0034] The radiofrequency steam ablation catheter provided by the present application expands the balloon on the catheter to expand a section of the duodenum, uses high-frequency electric heating to heat the saline at the distal end of the catheter to generate instant steam, and the hot steam emitted from the head end of the catheter is uniformly sprayed on the mucosa of the inner surface of the duodenum, thereby achieving the treatment purpose of ablation.

[0035] The manufacturing method of the radio frequency steam ablation catheter is simple in process, easy to operate and high in success rate.

[0036] The radio frequency steam ablation system is used for inserting the radio frequency steam ablation catheter into the duodenum under the guidance of the endoscope, and can make the endoscopic treatment operation of weight loss and metabolism more minimally invasive, and is simple, fast, safe and reliable in operation, and is beneficial to uniformly ablate the mucosa of the inner surface of the duodenum, and other instruments needed to be used are less. BRIEF DESCRIPTION OF DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the specific embodiments or the prior art, the drawings needed to be used in the specific embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0038] Figure 1 The structure diagram of the radio frequency steam ablation catheter is provided for an embodiment of the present application;

[0039] Figure 2 The cross-sectional view of the four-lumen tube is provided for an embodiment of the present application;

[0040] Figure 3 The manufacturing flowchart of the radio frequency steam ablation catheter is provided for an embodiment of the present application;

[0041] Figure 4 The structure diagram of the radio frequency steam ablation system is provided for an embodiment of the present application.

[0042] The figure shows that: 1-balloon body; 2-four-lumen tube; 3-sheath; 4-handle; 5-single-lumen tube; 6-luer connector; 7-electrical connector; 11-exhaust hole; 21-balloon inflation lumen; 22-saline lumen; 23-wire lumen. DETAILED DESCRIPTION

[0043] The technical solutions of the present application will be described clearly and completely in combination with the embodiments. Obviously, the described embodiments are some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the present application.

[0044] According to the first aspect of the present application, a radio frequency steam ablation catheter is provided, and the tube cavity of the radio frequency steam ablation catheter comprises a balloon inflation lumen, a saline lumen, a wire lumen and an exhaust hole.

[0045] The balloon inflation cavity is communicated with the balloon at the distal end of the catheter, and the balloon is inflated by gas;

[0046] The saline cavity is used to deliver saline to the distal end of the catheter;

[0047] Meanwhile, the saline cavity is provided with an electrode at the distal end of the catheter to heat the saline to generate steam;

[0048] The wire cavity is used to pass through the wire to connect the wire to the electrode in the saline cavity;

[0049] The exhaust hole is arranged between the balloons and communicated with the saline cavity to spray out the steam.

[0050] In the present application, the radiofrequency steam ablation catheter inflates a section of duodenum by the balloon on the catheter, generates instant steam by heating the saline with high frequency electricity at the distal end of the catheter, and the hot steam emitted from the head end of the catheter is uniformly sprayed on the mucosa of the inner surface of the inflated duodenum to achieve the treatment purpose of ablation.

[0051] It should be noted that steam ablation is different from weight loss surgery and metabolic endoscopic surgery, which does not cause a large incision, but only ablates the shallow intestinal wall tissue by steam heat to affect the metabolic regulation function of the duodenum. At the same time, the current common surgical procedure of weight loss surgery causes a large incision, and the steam causes a very shallow incision due to its diffusivity, and the ablation area is larger and more uniform.

[0052] In a preferred embodiment, the number of balloons can be at least two, and can be further preferred to be two, and the distance between the balloons can be 1-10 cm. One balloon can be attached to the catheter as close to the head end of the catheter as possible, and the other balloon can be attached to the catheter at a distance of 1-10 cm apart. The arrangement of two balloons can limit the steam to the required ablation section of the intestine to avoid excessive ablation caused by the steam contacting the place that does not need to be ablated.

[0053] In the present application, the balloon material can be a non-compliant balloon, and the shape can be approximately spherical and / or spindle-shaped, and the outer diameter can be set to multiple specifications according to the anatomical size of the human body. The balloon is communicated with the balloon inflation cavity of the catheter at the distal end of the catheter, and the balloon inflation cavity can be communicated and led out at the proximal end of the catheter by a luer connector and a single lumen catheter. In operation, the balloon is inflated by a syringe through the luer connector to make it swell up.

[0054] In a preferred embodiment, the electrode in the saline cavity includes but is not limited to a corrugated electrode.

[0055] In the present application, two metal electrodes are installed in the brine cavity near the exhaust port at the distal end of the catheter, both of which can be corrugated electrodes, and the two metal electrodes are separated by a small distance without contact; the brine cavity at the proximal end of the catheter can be connected and led out by a luer connector and a single lumen catheter; in operation, the brine is transported between the two metal electrodes in the brine cavity by using a brine perfusion pump, and the metal electrodes heat the brine flowing between the electrodes to vaporize the brine into hot steam, which is then sprayed out through the exhaust port.

[0056] In the present application, the number of wire cavities can be two, and the metal wires pass through the wire cavities; at the proximal end of the catheter, the metal wires are connected and led out by a panel connector and insulated wires; at the distal end of the catheter, the metal wires enter the brine cavity and are connected to the two metal electrodes; the electric power output of the radio frequency generator is transmitted to the two metal electrodes in the brine cavity through the panel connector and the metal wires, so that the metal electrodes heat the brine to generate steam.

[0057] In a preferred embodiment, the exhaust ports are arranged in at least two rows along the catheter axis, and the number of exhaust ports in each row is at least three.

[0058] In the present application, the exhaust ports are arranged between the two balloons at the distal end of the catheter, and can be arranged in 2, 3, 4 or 5 rows along the catheter axis, and the number of exhaust ports in each row can be 3, 4, 5, 6, 7, 8, 9 or 10.

[0059] A typical structure of a radio frequency steam ablation catheter is shown in Figure 1 and Figure 2 The four lumen tube 2 is the main body, and the balloon inflation cavity 21, the brine cavity 22 and the wire cavity 23 are constructed in the four lumen tube 2;

[0060] Specifically, one cavity in the four lumen tube 2 is used as the balloon inflation cavity 21 (balloon expansion channel), which is connected to the two balloon bodies 1 at the distal end of the catheter for inflating the balloon bodies 1 by air; at the proximal end of the catheter, the balloon inflation cavity is connected and led out by a luer connector 6 and a single lumen tube 5, and the balloon inflation cavity is connected to an external air pump;

[0061] Another cavity in the four lumen tube 2 is used as the brine cavity 22 for transporting brine to the distal end of the catheter; at the same time, the brine cavity 22 is used as an electrode installation channel, which is provided with an electrode pair at the distal end of the catheter for heating the brine flowing between the electrodes to generate hot steam; at the proximal end of the catheter, the brine cavity is connected and led out by a luer connector 6 and a single lumen tube 5, and the brine cavity is connected to an external brine perfusion pump;

[0062] The exhaust holes 11 are arranged between the two balloon bodies 1, and are arranged in 2, 3, 4 or 5 rows along the catheter axis, and are communicated with the saline cavity, and the hot steam is sprayed out through the exhaust holes and uniformly sprayed on the mucous membrane of the inner surface of the already expanded duodenum;

[0063] The other two cavities in the four-cavity tube 2 are used as wire cavities 23, and metal wires pass through the passages, and the metal wires are connected to the distal end of the catheter, and the metal wires enter the saline cavity and are connected with the electrode pair; at the proximal end of the catheter, the metal wires are connected out of the catheter through a panel connector and an insulating wire, and the metal wires are connected to an external radio frequency generator.

[0064] It should be noted that the four-cavity tube 2 is connected with the single-cavity tube 5 through a Y joint, and the saline passage is led out to one single-cavity tube through welding, the balloon expansion passage is led out to the other single-cavity tube, and the wires in the two wire passages are led out to the outside and sealed at the outlet.

[0065] According to a second aspect of the present application, a manufacturing method of the radio frequency steam ablation catheter is provided, and the method comprises the following steps:

[0066] After the pipeline is cut, the balloon connection holes and the exhaust holes are opened at the distal end of the pipeline, the balloon is connected on the pipeline, then the wires are passed through the pipeline, the wire heads are welded with the electrodes, the electrodes are inserted into the saline cavity, then the exhaust section pipeline is connected, the head end of the pipeline is made into a circular arc, finally the saline cavity, the wires and the balloon inflation cavity are led out at the proximal end of the catheter, and the radio frequency steam ablation catheter is obtained.

[0067] In the present application, the manufacturing method further comprises the following steps:

[0068] At the proximal end of the catheter, the balloon inflation cavity is led out through a luer joint and a single-cavity tube.

[0069] The manufacturing method of the radio frequency steam ablation catheter provided by the present application has the advantages of simple process, easy operation and high success rate.

[0070] A typical manufacturing method of a radio frequency steam ablation catheter is shown in Figure 3 , and the method comprises the following steps:

[0071] Step one: cutting the pipeline, the four-cavity catheter is cut into a required length;

[0072] Step two: opening the balloon connection holes and the exhaust holes at the distal end of the pipeline, one hole is opened at each balloon position, and the holes are opened by using a special arc-shaped knife to cut from the side; between the balloons, the exhaust holes are processed by using a special arc-shaped knife to cut from the side, or by using a temperature-controlled heating needle to punch radially, or by using punching and / or laser punching and the like, so that the exhaust holes are processed;

[0073] Step three: welding or bonding the balloon on the tube, putting the processed balloon into the tube, clamping the balloon openings on the tube with a cold mold, and bonding with temperature-controlled welding or glue;

[0074] Step four: threading a metal wire on the tube, threading a thinner guide wire through the four-lumen tube first, then connecting the metal wire, and then pulling the guide wire to pull the metal wire into the four-lumen tube;

[0075] Step five: welding an electrode on the head end of the metal wire, and welding the processed electrode sheet on the metal wire at the distal end of the tube;

[0076] Step six: hot melting the electrode back into the saline lumen of the tube, fixing the welded electrode on a stepped fixture similar to a round rod, pushing them into the saline lumen of the tube in reverse, clamping them with an arc-shaped clamp outside the tube, heating the arc-shaped clamp for a period of time, and then removing the clamp. The electrode is left in the saline lumen of the tube and is fixed. To prevent the other cavities of the tube from collapsing under high temperature, a high-temperature-resistant core rod should be threaded through the other cavities;

[0077] Step seven: welding / fusing the exhaust section of the tube, and temperature-controlled fusing another section of the tube with the above-mentioned processed semi-finished catheter. To prevent the other cavities of the tube from collapsing under high temperature, a high-temperature-resistant core rod should be threaded through the other cavities;

[0078] Step eight: hot melting the head end of the tube into a circular arc, using mechanical polishing or hot melting methods to process the head end of the tube into a circular arc to avoid injuring the tissue during use;

[0079] Step nine: leading out the saline lumen, metal wire, and balloon inflation lumen, leading out the metal wire at the proximal end of the tube with a clamp; at the same time, connecting the saline lumen and balloon inflation lumen of the four-lumen tube 2 with the lead-out tube, inserting a core rod in between, and temperature-controlled fusing for a period of time to independently lead out all the saline lumen, metal wire, and balloon inflation lumen.

[0080] According to a third aspect of the present application, a radiofrequency steam ablation system is provided, comprising the radiofrequency steam ablation catheter of any one of the above.

[0081] In the present application, the host of the radiofrequency steam ablation system includes but is not limited to a microprocessor, a radiofrequency generator, and a saline perfusion pump.

[0082] In the radiofrequency steam ablation system, see Figure 4The host (microprocessor, radio frequency generator and saline perfusion pump) is connected with the radio frequency steam ablation catheter; the electric power output of the radio frequency generator is transmitted to the two metal electrodes in the saline cavity through the panel connector and metal wire, and the saline perfusion pump transmits the saline to the space between the two metal electrodes in the saline cavity, so that the metal electrodes can heat the flowing saline, and then generate hot steam, which is sprayed out through the exhaust hole.

[0083] The radio frequency steam ablation system provided by the application can not only make the endoscopic treatment operation of weight loss and metabolism more minimally invasive, but also is simple, fast, safe and reliable in operation, is beneficial to uniform ablation of the mucosa of the inner surface of the duodenum, and needs less other instruments.

[0084] The application will be further described by examples. If not otherwise specified, the materials in the examples are prepared according to the existing methods or directly purchased from the market.

[0085] Example 1

[0086] A radio frequency steam ablation catheter, the structure of which is shown in Figure 1 and Figure 2 The radio frequency steam ablation catheter takes the four-lumen tube 2 as the main body, and constructs the balloon inflation cavity 21, the saline cavity 22 and the wire cavity 23 in the four-lumen tube 2.

[0087] Specifically, one cavity in the four-lumen tube 2 is used as the balloon inflation cavity 21 (balloon expansion channel), which is communicated with the two balloon bodies 1 at the distal end of the catheter, and is used for inflating the balloon bodies 1 by air; at the proximal end of the catheter, the balloon inflation cavity is communicated and led out by the luer joint 6 and the single-lumen tube 5, and the balloon inflation cavity is connected with the external air pump.

[0088] The distance between the two balloons is 10 cm, and the balloon is a non-compliant balloon with a spindle shape.

[0089] Another cavity in the four-lumen tube 2 is used as the saline cavity 22, which is used for conveying the saline to the distal end of the catheter; at the same time, the saline cavity 22 is used as the electrode installation channel, which is provided with an electrode pair at the distal end of the catheter, and is used for heating the saline flowing between the electrodes to generate hot steam; at the proximal end of the catheter, the saline cavity is communicated and led out by the luer joint 6 and the single-lumen tube 5, and the saline cavity is connected with the external saline perfusion pump.

[0090] The electrodes in the saline cavity are corrugated electrodes, which are spaced apart from each other without contact.

[0091] The exhaust holes 11 are arranged between the two balloon bodies 1, and are arranged in five rows along the catheter axis, with five exhaust holes in each row. The exhaust holes are in communication with the saline cavity, and the hot steam is sprayed out of the exhaust holes and uniformly sprayed on the mucosa of the inner surface of the already expanded duodenum.

[0092] The remaining two cavities in the four-cavity tube 2 are used as wire cavities 23, through which metal wires pass, and are used to pass the metal wires to connect to the distal end of the catheter. The metal wires enter the saline cavity and are connected to the electrode pair. At the proximal end of the catheter, the metal wires are connected out of the catheter with a panel connector and insulated wires, and the metal wires are connected to an external radio frequency generator.

[0093] The four-cavity tube 2 is connected to the single-cavity tube 5 through a Y joint.

[0094] Example 2

[0095] The embodiment provides a radio frequency steam ablation catheter, which is different from the embodiment 1 only in that the shape of the balloon is approximately spherical.

[0096] The rest is the same as the embodiment 1.

[0097] Example 3

[0098] The embodiment provides a radio frequency steam ablation catheter, which is different from the embodiment 1 only in that the distance between the balloons is 5 cm.

[0099] The rest is the same as the embodiment 1.

[0100] Example 4

[0101] The embodiment provides a radio frequency steam ablation catheter, which is different from the embodiment 1 only in that the distance between the balloons is 1 cm.

[0102] The rest is the same as the embodiment 1.

[0103] Example 5

[0104] The embodiment provides a radio frequency steam ablation catheter, which is different from the embodiment 1 only in that the balloon inflation cavity is connected to only one balloon at the distal end of the catheter.

[0105] The rest is the same as the embodiment 1.

[0106] Compared with the embodiment 1, the defect of the embodiment is that the steam cannot be limited in the required ablation intestinal segment, and the steam may contact the place that does not need to be ablated, resulting in excessive ablation.

[0107] Example 6

[0108] The embodiment is a manufacturing method of the radio frequency steam ablation catheter of the embodiment 1, and includes the following steps:

[0109] Step one: cutting the tube, cutting the four-lumen tube 2 into the required length;

[0110] Step two: punching balloon connection holes and exhaust holes at the distal end of the tube, one hole for each balloon position, using a special arc-shaped knife to cut from the side; between the balloons, using a special arc-shaped knife to cut from the side, or using a temperature-controlled heating needle to punch radially, or using punching and / or laser punching, etc., to process the exhaust holes;

[0111] Step three: welding or bonding the balloon on the tube, putting the processed balloon into the tube, and using a cold mold to clamp the balloon openings at both ends of the tube, and using temperature-controlled welding or glue bonding;

[0112] Step four: threading the metal wire through the tube, threading a thinner guide wire through the four-lumen tube first, then connecting the metal wire, and then pulling the guide wire to pull the metal wire into the four-lumen tube;

[0113] Step five: welding the electrode at the head end of the metal wire, and welding the processed electrode sheet onto the metal wire at the distal end of the tube;

[0114] Step six: hot melting the electrode back into the tube's saline cavity, fixing the welded electrode on a stepped fixture similar to a circular rod, and pushing them into the tube's saline cavity in reverse, then clamping them with an arc-shaped clamp outside the tube, heating the arc-shaped clamp for a period of time, and then removing the clamp. The electrode is fixed in the tube's saline cavity. To prevent other cavities of the tube from collapsing under high temperature, a high-temperature-resistant core rod should be inserted into each of the other cavities;

[0115] It should be noted that the protrusions formed by the tube material under high temperature and pressure will harden into steps after cooling, thereby fixing the electrode sheet;

[0116] Step seven: welding / fusing the exhaust section of the tube, temperature-controlled fusing another section of the tube with the above-mentioned semi-finished catheter, and inserting a high-temperature-resistant core rod into each of the other cavities to prevent them from collapsing under high temperature;

[0117] Step eight: hot melting the tube head into a circular arc, using mechanical polishing or hot melting methods to hot melt the tube head into a circular arc to avoid injuring the tissue during use;

[0118] Step nine: leading out the saline cavity, metal wire, and balloon inflation cavity, leading out the metal wire at the proximal end of the tube with a clamp; at the same time, connecting the saline cavity and balloon inflation cavity of the four-lumen tube 2 with the lead-out tube, inserting a core rod in between, and temperature-controlled fusing for a period of time to independently lead out all the saline cavities, metal wires, and balloon inflation cavities.

[0119] Comparative Example 1

[0120] The comparative example provides a radio frequency steam ablation catheter, which is different from the example 1 only in that no balloon inflation cavity is arranged on the catheter;

[0121] The rest is the same as the example 1.

[0122] Compared with the example 1, the comparative example has a defect that the duodenum cannot be inflated by the balloon, and the treatment purpose of ablation cannot be achieved.

[0123] Comparative example 2

[0124] The comparative example provides a radio frequency steam ablation catheter, which is different from the example 1 only in that no balloon inflation cavity is arranged on the catheter;

[0125] The rest is the same as the example 1.

[0126] Compared with the example 1, the comparative example has a defect that the duodenum cannot be inflated by the balloon, and the treatment purpose of ablation cannot be achieved.

[0127] Comparative example 3

[0128] The comparative example provides a radio frequency steam ablation catheter, which is different from the example 1 only in that no saline cavity is arranged in the catheter;

[0129] The rest is the same as the example 1.

[0130] Compared with the example 1, the comparative example has a defect that the duodenum cannot be inflated by the balloon, and the treatment purpose of ablation cannot be achieved.

[0131] Comparative example 4

[0132] The comparative example provides a radio frequency steam ablation catheter, which is different from the example 1 only in that no exhaust hole is arranged between the balloons;

[0133] The rest is the same as the example 1.

[0134] Compared with the example 1, the comparative example has a defect that the steam generated by the saline cavity cannot be uniformly sprayed on the inner mucosa of the inflated duodenum, and the treatment purpose of ablation cannot be achieved.

[0135] Finally, it should be noted that: the above examples are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing examples, or make equivalent replacement for part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A radiofrequency vapor ablation catheter, characterized in that, The lumen of the radiofrequency vapor ablation catheter includes a balloon inflation chamber, a saline chamber, a lead wire chamber, and an exhaust port. The balloon inflation chamber is connected to the balloon at the distal end of the catheter, and the balloon is inflated with gas. The saline chamber is used to deliver saline to the distal end of the catheter; The saline chamber has an electrode at the distal end of the conduit to heat the saline to generate steam; The wire cavity is used to pass wires through to connect the wires to the electrodes inside the saline cavity; The vent holes are arranged between the balloons and communicate with the saline chamber for ejecting steam.

2. The radiofrequency vapor ablation catheter according to claim 1, characterized in that, The number of balloons is at least two; Preferably, the number of balloons is two.

3. The radiofrequency vapor ablation catheter according to claim 2, characterized in that, The distance between the balloons is 1cm to 10cm; Preferably, the balloon is a non-compliant balloon; Preferably, the balloon is approximately spherical and / or spindle-shaped.

4. The radiofrequency vapor ablation catheter according to any one of claims 1-3, characterized in that, The electrodes within the saline chamber include corrugated electrodes; Preferably, the electrodes within the saline chamber are spaced apart from each other and do not contact each other.

5. The radiofrequency vapor ablation catheter according to any one of claims 1-3, characterized in that, The number of wire cavities is two.

6. The radiofrequency vapor ablation catheter according to any one of claims 1-3, characterized in that, The exhaust holes are arranged in at least two rows along the axial direction of the conduit. Preferably, there are at least three exhaust holes in each row.

7. A method for manufacturing a radiofrequency vapor ablation catheter according to any one of claims 1-6, characterized in that, Includes the following steps: After cutting the tubing, a balloon connection hole and an exhaust hole are made at the distal end of the tubing. The balloon is then connected to the tubing, and a wire is passed through the tubing. An electrode is welded to the end of the wire and then inserted back into the saline chamber for installation. After that, the exhaust section of the tubing is connected, and the end of the tubing is made into an arc shape. Finally, the saline chamber, the wire, and the balloon filling chamber are led out from the proximal end of the catheter to obtain the radiofrequency vapor ablation catheter.

8. The manufacturing method according to claim 7, characterized in that, The manufacturing method also includes the following steps: At the proximal end of the catheter, the balloon filling cavity is led out through a Luer connector and a single-lumen catheter.

9. A radiofrequency vapor ablation system, characterized in that, Includes the radiofrequency vapor ablation catheter as described in any one of claims 1-6.

10. The radiofrequency vapor ablation system according to claim 9, characterized in that, The main unit of the radiofrequency vapor ablation system includes a microprocessor, a radiofrequency generator, and a saline infusion pump.

Images