Esophageal thermal injury protection device

Abstract

The present application proposes an esophageal thermal injury protection device, which includes a main body and a negative pressure pipeline; the main body is used to be placed in the esophagus; an annular upper airbag is arranged around the upper end of the main body, and an annular lower airbag is arranged around the lower end of the main body; the upper airbag and the lower airbag are used to support the esophagus at the upper and lower parts; the upper airbag is connected to the upper pipeline, and the lower airbag is connected to the lower pipeline; a plurality of through holes are formed on the main body, which are connected to the internal space of the main body; the upper end of the negative pressure pipeline extends to the outside, and the lower end of the negative pressure pipeline passes through the upper end sheet and is connected to the internal space of the main body; the negative pressure pipeline is used to suction the internal space of the main body and the collapsed space of the esophagus, so that the esophagus forms a collapse in the collapsed space of the esophagus and is away from the ablation area. The esophageal thermal injury protection device of the present application, by creating a collapse in the esophagus, allows the esophageal wall to be away from the ablation area during catheter ablation of atrial fibrillation, thereby preventing esophageal thermal injury and the formation of left atrial esophageal fistula.

Description

Technical Field

[0001] The present application relates to an esophageal thermal damage protection device used in atrial fibrillation catheter ablation, and more particularly to an esophageal thermal damage protection device. Background Art

[0002] Atrial fibrillation is one of the most common arrhythmias. Its prevalence and incidence gradually increase with age. There are about 60 million patients with atrial fibrillation worldwide. Atrial fibrillation causes a 1.5-fold increase in all-cause mortality in men and a 2-fold increase in mortality in women. Atrial fibrillation is extremely harmful and can lead to stroke and thromboembolism, heart failure, myocardial infarction, cognitive decline and dementia, renal damage and a decline in quality of life. It is a global health hazard.

[0003] The heart of a normal person is controlled by sinus rhythm, which is stable and has a moderate frequency. However, when atrial fibrillation occurs, the regular contraction and relaxation of the heart are lost, and a fast and extremely disordered heart rhythm occurs. The effective contraction function of the atrium is lost, the internal blood flow is slow, and the cardiac output decreases, resulting in a series of serious consequences such as clinical symptoms such as palpitations and chest tightness, and thromboembolism.

[0004] It is currently believed that atrial fibrillation is related to the pulmonary veins and other venous systems connected to the atria. In these venous systems, there are myocardiums that can spontaneously generate electrical activity, which are triggering foci for atrial fibrillation. Effectively eliminating these triggering foci, or preventing the electrical activity of these triggering foci from being transmitted to the atrial tissue, can control the occurrence of atrial fibrillation. The most common triggering foci are the pulmonary veins connected to the left atrium. Previous literature has shown that 90% of atrial fibrillation is related to the pulmonary vein triggering foci.

[0005] Catheter ablation has become the main treatment for atrial fibrillation, among which transcatheter radiofrequency ablation is currently the most mainstream treatment method. This method is mainly implemented using the three-dimensional electroanatomical mapping system of Johnson & Johnson (Biosense Webster). Radiofrequency ablation releases radiofrequency energy on the surface of the atrial endothelium, which is converted into heat energy in the tissue, and causes degeneration and necrosis of related tissues in the atrium through thermal damage, forming atrial transmural damage, so that the pulmonary veins that cause atrial fibrillation and the atrium are electrically isolated, and the occurrence of atrial fibrillation is controlled by eliminating the triggering focus of pulmonary vein electrical activity. However, if permanent transmural damage cannot be formed, the electrical conduction between the pulmonary veins and the left atrium will still exist, which is one of the important reasons for the failure of catheter ablation for atrial fibrillation.

[0006] Although it is possible to create permanent transmural damage at the junction of the pulmonary vein and the left atrium by increasing the ablation time and power, this method may also lead to a significant increase in the patient's surgical risk because in some special areas, prolonging the ablation time and increasing the ablation power may damage important extracardiac organs adjacent to the ablation site.

[0007] The esophagus is located in the posterior mediastinum, separated from the posterior wall of the left atrium only by the oblique pericardial sinus. Cummings' study showed that 28.4% (23 / 81) of patients had their esophagus running along the right pulmonary vein opening on the posterior wall of the left atrium, 38.3% (31 / 81) along the left pulmonary vein opening, and 33.3% (37 / 81) running between the bilateral pulmonary veins. The posterior wall of the left atrium and the anterior wall of the esophagus are both very thin, with a thickness of 2.2±0.9 (0.9-7.4) mm and a thickness of 3.6±1.7 (1.3-6.2) mm on the anterior wall of the esophagus adjacent to the left atrium. There is a discontinuous fat pad with a thickness of 0.9±0.2 mm between the left atrium and the esophagus. The left atrium and the esophagus have a direct contact surface of more than 5 cm in the long axis direction and a direct contact surface of 10-15 mm in the short axis direction. From the above anatomical characteristics, it can be seen that during radiofrequency ablation of atrial fibrillation, some ablation "target areas" will fall within the part where the left atrium and esophagus are in direct contact. Excessive ablation will cause damage to both the left atrium and esophagus. When the damage reaches a certain level, a catastrophic consequence will occur - the appearance of a left atrial esophageal fistula. Once this complication occurs, the mortality rate reported in the literature can reach 50-90%. Therefore, it is of great significance to reduce or even completely avoid thermal damage to the esophagus during radiofrequency ablation.

[0008] In order to avoid the occurrence of left atrial esophageal fistula, some researchers have proposed their own solutions, including: ① Controlling the power during ablation, designing the ablation line away from the esophagus, and monitoring the temperature in the esophageal cavity. However, the decrease in ablation power may lead to the failure to form transmural damage. Due to the close proximity of the left atrium and the pulmonary vein in anatomy, and the spontaneous contraction of the esophagus, the ablation line away from the esophagus is difficult to accurately delineate in actual operation. While monitoring the temperature in the esophageal cavity can avoid thermal damage due to excessive temperature in the esophagus, this method cannot guarantee sufficient ablation intensity, which often leads to a decrease in the success rate of the operation. ② Use mechanical force to displace the esophagus during ablation to avoid thermal damage. The common point of these technologies is that mechanical methods (inserting a shaping balloon, ultrasound probe, rod, nitinol structure or a plastic metal core into the esophagus) are used to push the esophagus from the inside during ablation to keep it away from the ablation heat source and reduce thermal damage. Although these methods have a certain effect in some patients, they have significant shortcomings. First, mechanical pulling occurs inside the esophageal cavity, and the mechanical force can only act on the opposite side of the esophageal wall that is far away from the ablation heat source (the left or right side when the human body lies flat). Since the esophagus is a soft and elastic tubular structure, the push on one side of the esophageal wall will first cause the esophageal morphology to deform, resulting in a significant decrease in the same-direction movement of the other side of the esophageal wall (close to the ablation heat source). If the esophageal wall on this side is to have a sufficient positional offset, it is necessary to apply a greater force on the other side of the mechanical push, but excessive force may damage the esophagus. Therefore, mechanical pulling inside the esophagus is a solution with low efficiency and safety; ③ Some researchers use specially designed transesophageal catheters and puncture needles to inject carbon dioxide gas into the connective fat tissue between the left atrium and the esophagus, forming a local structure similar to "emphysema", thereby increasing the distance between the left atrium and the esophagus to reduce or eliminate thermal damage. This method may be effective for some patients, but the disadvantages are also obvious. Risk 1: Puncture causes esophageal trauma, which may lead to bleeding and infection. Patients with atrial fibrillation often take oral anticoagulants at the same time, which reduces blood coagulability. In addition, heparin is given intravenously for anticoagulation during atrial fibrillation ablation. Therefore, the risk of bleeding caused by esophageal puncture cannot be ignored. In addition, the normal esophagus is in a bacterial state, and esophageal puncture may cause infection of the mediastinum outside the esophagus. The second risk: more importantly, it may damage the left atrium, leading to life-threatening pericardial tamponade and mediastinal hematoma. Cummings et al. used intracardiac ultrasound (ICE) to measure that the posterior wall of the left atrium is only 2.2±0.9 (0.9-7.4) mm, and the distance from the esophageal lining to the left atrial lining is 4.2±2.1 mm. In other words, the minimum distance from the inside of the esophagus to the outside may be only about 2 mm to enter the left atrium. Once the esophagus moves spontaneously or the patient's body position changes suddenly (coughing, etc.), it is very likely that the posterior wall of the left atrium will be damaged and bleeding, and even fatal pericardial tamponade and mediastinal hematoma will occur, and the consequences are extremely serious.Risk 3: Although researchers of this method believe that carbon dioxide can be dissolved in the blood, a certain amount of carbon dioxide will not produce adverse consequences. But first of all, carbon dioxide is only soluble in water, not easily soluble in water, and its dissolution rate is not fast. In addition, a certain amount of carbon dioxide has been dissolved in human blood, so when carbon dioxide is accidentally injected into the left atrium, it is possible to form bubbles. Second, due to the fluidity of human blood, these carbon dioxide bubbles may quickly pass through the left ventricle and enter the patient's right coronary artery, which may cause varying degrees of gas embolism and block coronary blood flow. At this time, the patient will experience severe chest tightness and agitation, further increasing the potential risk of the puncture system that has been inserted into the esophagus. Risk 4: Literature reports that the fat tissue between the posterior wall of the left atrium and the anterior wall of the esophagus is of varying thickness (about 0.9±0.2mm) and does not exist continuously. Therefore, in some patients, the reliability of the formation of a sufficient carbon dioxide "cushion" remains to be verified. Summary of the invention

[0009] In view of the above problems, the present application aims to provide an esophageal thermal damage protection device, which is used in atrial fibrillation catheter ablation to prevent esophageal thermal damage and left atrial esophageal fistula formation.

[0010] The present application proposes an esophageal thermal injury protection device, which includes a main pipe body and a negative pressure pipe;

[0011] The main tube is intended to be placed in the esophagus;

[0012] The upper part of the main body is closed by an upper end piece, and the lower end is closed by a lower end piece, thereby forming an internal space of the main body;

[0013] An annular upper air bag is arranged around the upper end of the main body, and an annular lower air bag is arranged around the lower end of the main body; the upper air bag and the lower air bag are used to support the esophagus at the upper and lower parts; the space in the esophagus defined by the upper air bag, the lower air bag and the outer peripheral surface of the main body is the esophageal collapse space;

[0014] The main body is located at an eccentric position of the upper balloon and the lower balloon, so that the upper balloon and the lower balloon extend outward in the direction of the main body toward the ablation area greater than the extension in other directions of the main body, thereby the space in the direction of the ablation area occupies most of the space of the esophageal collapse space;

[0015] The upper airbag is connected to an upper pipeline, which extends upward from the inside of the main body through the upper end piece to the outside, and the upper airbag is inflated or deflated through the upper pipeline; the lower airbag is connected to a lower pipeline, which extends upward from the inside of the main body through the upper end piece to the outside, and the lower airbag is inflated or deflated through the lower pipeline;

[0016] A plurality of through holes are formed on the main body; the plurality of through holes are arranged along the length direction of the main body and communicate with the internal space of the main body;

[0017] The upper end of the negative pressure pipeline extends to the outside, and the lower end of the negative pressure pipeline passes through the upper end piece and is connected to the internal space of the main pipe; the negative pressure pipeline is used to suction the internal space of the main pipe and the collapsed space of the esophagus, so that the esophagus collapses in the collapsed space of the esophagus and moves away from the ablation area.

[0018] Preferably, it also includes a wire guide tube;

[0019] The wire guide tube is formed in the main body; the upper end of the wire guide tube passes through the upper end piece, and the lower end of the wire guide tube passes through the lower end piece;

[0020] The guidewire tube is used to accommodate a guidewire, and the guidewire is used to guide the main tube to a predetermined position of the esophagus.

[0021] Preferably, the upper portion of the main body further comprises a handle, so as to adjust the angle and position of the main body in the esophagus through the handle.

[0022] Preferably, the handle is formed at the upper end of the wire guide tube or the upper end of the main tube body.

[0023] Preferably, a partition is formed in the main pipe, and the partition is formed along the length direction of the main pipe to separate the internal space of the main pipe into an independent first internal space and a second internal space;

[0024] The negative pressure pipeline includes a first negative pressure pipeline and a second negative pressure pipeline; the first negative pressure pipeline is connected to the first internal space; the second negative pressure pipeline is connected to the second internal space;

[0025] At least a portion of the through holes is communicated with the first internal space; at least a portion of the through holes is communicated with the second internal space.

[0026] Preferably, the first inner space corresponds to the direction of the ablation zone.

[0027] Preferably, a contrast agent input port is further formed at the upper end of the negative pressure pipeline, and the contrast agent is used to be sprayed onto the inner wall of the esophagus by utilizing the negative pressure of the internal space of the main tube and the collapsed space of the esophagus.

[0028] Preferably, a first contrast agent input port is further formed at the upper end of the first negative pressure pipeline, and a second contrast agent input port is further formed at the upper end of the second negative pressure pipeline.

[0029] Preferably, a stopper is formed at the lower end of the guide wire.

[0030] Preferably, the stopper is arc-shaped or spherical.

[0031] The esophageal thermal injury protection device of the present application creates collapse in the esophagus so that the esophageal wall can be away from the ablation area during catheter ablation of atrial fibrillation, thereby preventing esophageal thermal injury and left atrial esophageal fistula formation. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a schematic diagram of the main structure of the first embodiment of the esophageal thermal damage protection device of the present application;

[0033] Figure 2 for Figure 1 A schematic diagram of the cross-sectional structure of the esophageal thermal injury protection device;

[0034] Figure 3 It is a schematic diagram of the front structure of the second embodiment of the esophageal thermal damage protection device of the present application;

[0035] Figure 4 for Figure 3 A schematic diagram of the cross-sectional structure of the esophageal thermal injury protection device;

[0036] Figure 5 Schematic diagram of placing a guide wire into the esophagus using a gastric tube;

[0037] Figure 6 This is a schematic diagram of the removal of the gastric tube after the guide wire is placed in the esophagus;

[0038] Figure 7 , 8 A schematic diagram of placing the esophageal thermal injury protection device of the present application into the esophagus using a guide wire;

[0039] Fig. 9 A schematic diagram of inflating the esophageal thermal injury protection device of the present application so as to fix it in the esophagus;

[0040] Fig.10 A schematic diagram of the esophageal thermal injury protection device of the present application being sucked out by negative pressure so that the corresponding segment of the esophagus collapses and moves away from the ablation area;

[0041] Fig.11 Schematic diagram of injection of contrast medium into the collapsed segment of the esophagus;

[0042] Fig.12 This is a schematic diagram of the displacement of the inner wall of the test tube caused by the esophageal thermal damage protection device of the present application. DETAILED DESCRIPTION

[0043] Below, the esophageal thermal damage protection device of the present application is described in detail with reference to the accompanying drawings.

[0044] Figure 1-2 This is the first embodiment of the present application.

[0045] Figure 1-2 The esophageal thermal injury protection device comprises a main pipe body 10 and a negative pressure pipe 15.

[0046] The main tube 10 is used to be placed in the esophagus 40 .

[0047] The upper portion of the main tube 40 is closed by an upper end piece 12 a , and the lower end is closed by a lower end piece 12 b , thereby forming an inner space 14 of the main tube.

[0048] An annular upper air bag 11a is arranged around the upper end of the main body 10, and an annular lower air bag 11b is arranged around the lower end of the main body 10; the upper air bag 11a and the lower air bag 11b are used to support the esophagus 40 at the upper and lower parts; the space in the esophagus 40 defined by the upper air bag 11a, the lower air bag 11b and the outer peripheral surface of the main body 10 is the esophageal collapse space.

[0049] The main body 10 is located at an eccentric position of the upper airbag 11a and the lower airbag 11b, so that the upper airbag 11a and the lower airbag 11b extend outward in the direction of the main body 10 toward the ablation area to a greater extent than in other directions of the main body 10. Thus, the space in the direction of the ablation area occupies most of the esophageal collapse space, that is, the portion of the esophagus corresponding to the direction of the ablation area has a greater possibility of collapse.

[0050] The upper airbag 11a is connected to an upper pipeline 16a, which extends upward from the inside of the main body 10 through the upper end piece 12a to the outside, and the upper airbag 11a is inflated or deflated through the upper pipeline 16a; the lower airbag 11b is connected to a lower pipeline 16b, which extends upward from the inside of the main body 10 through the upper end piece 12a to the outside, and the lower airbag 11b is inflated or deflated through the lower pipeline 16b. The upper pipeline 16a and the lower pipeline 16b are respectively used to connect to air sources.

[0051] A plurality of through holes 18 are formed on the main body 10 ; the plurality of through holes 18 are arranged along the length direction of the main body 10 and communicate with the internal space 14 of the main body.

[0052] The upper end of the negative pressure pipeline 15 extends to the outside, and the lower end of the negative pressure pipeline 15 passes through the upper end piece 12a to communicate with the internal space 14 of the main body; the negative pressure pipeline 15 is used to suction the internal space 14 of the main body and the esophageal collapse space, so that the esophagus 40 collapses in the esophageal collapse space and moves away from the ablation area.

[0053] In order to facilitate placement of the main body 10 at a predetermined position of the esophagus, the esophageal thermal damage protection device of the present application may further include a guide wire tube 13 .

[0054] The wire guide tube 13 is formed in the main body 10; the upper end of the wire guide tube 13 passes through the upper end piece 12a, and the lower end passes through the lower end piece 12b.

[0055] The guide wire tube 13 is used to accommodate a guide wire 20 , and the guide wire 20 is used to guide the main tube 10 to a predetermined position of the esophagus 40 .

[0056] The upper portion of the main tube body 10 further includes a handle 17 , so that the angle and position of the main tube body 10 in the esophagus 40 can be adjusted by the handle 17 .

[0057] The handle 17 is formed at the upper end of the wire guide tube 20 or the upper end of the main tube body 10 .

[0058] The upper end of the negative pressure pipeline 15 is further formed with a contrast agent input port 15b; thus, the upper end of the negative pressure pipeline 15 includes not only the negative pressure source connection end 15a, but also the contrast agent input end 15b. The contrast agent is used to utilize the negative pressure of the internal space 14 of the main body and the collapsed space of the esophagus to be sprayed onto the inner wall of the esophagus 40. When the contrast agent is injected, it diffuses to the esophageal wall near the ablation area, making it convenient to display the internal contour of the esophageal wall on this side under X-rays.

[0059] The lower end of the guide wire 20 is formed with a stopper 21. The stopper 21 is arc-shaped or spherical.

[0060] The structure of the second embodiment of the present application is mostly the same as that of the first embodiment, except that, in the second embodiment of the present application, Figure 3-4 As shown, a partition 19 is formed in the main body 10 . The partition 19 is formed along the length direction of the main body 10 to separate the internal space 14 of the main body into an independent first internal space 14 a and a second internal space 14 b .

[0061] In the second embodiment of the present application, the negative pressure pipeline 14 is divided into a first negative pressure pipeline 15 and a second negative pressure pipeline 18; the first negative pressure pipeline 15 is connected to the first internal space 14a; the second negative pressure pipeline 18 is connected to the second internal space 14b.

[0062] A portion of the through hole 18 is communicated with the first internal space 14 a ; a portion of the through hole 18 is communicated with the second internal space 14 b .

[0063] The first inner space 14a corresponds to the direction of the ablation zone.

[0064] A first contrast agent input port is further formed at the upper end of the first negative pressure pipeline 15, and a second contrast agent input port is further formed at the upper end of the second negative pressure pipeline 18. The first and second contrast agent input ports here are the same as the contrast agent input port 15b in the first embodiment, except that since the main body internal space 14 is divided into a first internal space 14a and a second internal space 14b, a negative pressure pipeline is formed corresponding to each space of the first internal space 14a and the second internal space 14b.

[0065] In addition, regardless of the first embodiment or the second embodiment, markers can be set on the upper and lower airbags to facilitate the use of imaging tools (ultrasound, X-ray, electromagnetic field, etc.) used in atrial fibrillation ablation to display the position of the main body, so as to achieve the best match between the esophageal deviation interval and the left atrium ablation target area, and minimize or even avoid esophageal thermal damage caused by ablation. For example, the marker can be a small piece of platinum-iridium alloy displayed under ultrasound, electromagnetic field and X-ray. In addition, the pressure in the upper and lower airbags can also be monitored by pressure monitoring means. Whether a miniature pressure sensor is set in the upper and lower airbags or a pressure sensing device is set on the corresponding pipeline connected to the upper and lower airbags, the pressure in the upper and lower airbags can be monitored.

[0066] Below, Figure 1-2 The first embodiment shown in the figure is taken as an example to illustrate the use process of the esophageal thermal injury protection device of the present application.

[0067] 1. Place a gastric tube with a guide wire before surgery, and insert it into the middle and lower esophagus or into the stomach cavity. Verify the position of the gastric tube by conventional standard methods, such as Figure 5 .

[0068] 2. Before ablation of the posterior wall of the left atrium, remove the gastric tube while the guidewire remains in the esophagus. Figure 6 ; Insert the guide wire into the main body, such as Figure 7 , 8 .

[0069] 3. Use the control handle to place the main body in the appropriate position of the esophagus, inflate the upper and lower air bags, and make the upper and lower air bags close to the inner wall of the esophagus. Thus, a closed space is formed in the esophagus through the upper and lower air bags and the main body, that is, the esophageal collapse space, such as Fig. 9 ;

[0070] 4. After stopping the inflation of the airbag, the internal space of the main body and the collapsed space of the esophagus are sucked through the negative pressure source and the negative pressure pipeline. The esophageal wall is sunken to different degrees into the collapsed space of the esophagus, such as Fig.10 As shown; due to the eccentric setting of the upper and lower airbags relative to the main tube, the esophageal wall on the side corresponding to the ablation area is more obviously recessed, making it significantly away from the position before the negative pressure is formed.

[0071] 5. Through the imaging tools used in atrial fibrillation ablation (ultrasound, X-ray, electromagnetic field, etc.), combined with the markers on the upper and lower balloons, the main tube can be positioned in the appropriate esophageal segment, and during the ablation procedure, dynamic adjustments can be made according to the specific location of the posterior wall of the left atrium to be ablated, to ensure that the esophagus produces the maximum esophageal wall displacement at the ablation site, thereby minimizing or even avoiding esophageal thermal damage.

[0072] The degree of esophageal wall displacement caused by the esophageal thermal injury protection device of the present application is sufficient to avoid thermal injury.

[0073] On the side where the esophageal wall is significantly displaced, the space formed by the displaced esophageal wall, the main body, and the upper and lower air sacs is approximately two right triangles facing each other, such as Fig.12 , where the right-angled side a is equivalent to the significant displacement of the esophageal wall, and the right-angled side b is twice the distance between the upper and lower air bags. For the same displacement a, if the right-angled side b is longer, it means that a longer section of the esophageal wall is used to produce the same displacement under negative pressure. In this way, the required negative pressure and local tension of the esophageal wall will be smaller (it can be measured by the acute angle θ formed by the hypotenuse c and the right-angled side b. The smaller this angle is, the smaller the local tension of the esophageal wall during displacement), which will cause less discomfort to the patient. Previous literature has shown that a displacement of 2 cm of the esophageal wall is sufficient to avoid thermal damage. According to the formula, the sum of the squares of the two right-angled sides is equal to the square of the hypotenuse, that is, a 2 +b 2 =c 2 , when θ=30°, a=2cm, b=3.464cm, the distance 2b between the upper and lower airbags is 6.928cm. When the distance between the upper and lower airbags is farther, when a displacement of 2cm is generated, θ<30°, which means that less local tension of the esophagus is generated.

[0074] Previous literature reports show that the distance the esophagus can move is about 4 cm. Other products cause esophageal displacement through local mechanical push, and the local tissue of the esophagus under force may be damaged.

[0075] More importantly, when mechanical pushing is used, the esophageal wall away from the ablation side is inevitably pushed, and the esophageal wall adjacent to the ablation site (which is the main site of thermal damage) is passively pulled. Due to the extensibility of the esophagus, the effect of this contralateral mechanical traction is limited. In order to produce sufficient displacement of the esophageal wall adjacent to the ablation site, a greater force must be applied on the contralateral side, which will undoubtedly increase the possibility of esophageal tissue damage.

[0076] In the present application, 1. First, the device is placed on the opposite side of the ablation site through the control handle, and the negative pressure is used to naturally displace the esophageal wall on the ablation side away from the ablation side. Due to the characteristics of negative pressure, the force on the entire displaced esophageal segment is relatively uniform, and the damage is small. 2. The esophageal wall adjacent to the ablation can produce the maximum displacement, while the opposite esophageal wall hardly displaces. 3. The displacement of the esophageal wall caused by negative pressure is different from the displacement caused by mechanical push. Mechanical push acts on a horizontal plane, while negative pressure causes the entire esophageal segment between the upper and lower air bags to contract inward, which can keep this esophageal segment as a whole away from the source of ablation thermal damage, so the effect is better, such as Fig.12 shown.

[0077] Unless otherwise defined, all technical and / or scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which the invention relates. The materials, methods and examples mentioned in this application are illustrative only and not limiting.

[0078] Although the present invention has been described in conjunction with specific embodiments, within the spirit of the invention of this application, those skilled in the art may make appropriate substitutions, modifications and changes, and such substitutions, modifications and changes still fall within the scope of protection of this application.

Claims

1. An esophageal thermal injury protection device, comprising a main body and a negative pressure pipeline; The main tube is intended to be placed in the esophagus; The upper part of the main body is closed by an upper end piece, and the lower end is closed by a lower end piece, thereby forming an internal space of the main body; An annular upper air bag is arranged around the upper end of the main body, and an annular lower air bag is arranged around the lower end of the main body; the upper air bag and the lower air bag are used to support the esophagus at the upper and lower parts; the space in the esophagus defined by the upper air bag, the lower air bag and the outer peripheral surface of the main body is the esophageal collapse space; The main tube is located at an eccentric position of the upper airbag and the lower airbag, so that the upper airbag and the lower airbag extend outward in the direction of the main tube toward the ablation area to a greater extent than in other directions of the main tube; The upper airbag is connected to an upper pipeline, which extends upward from the inside of the main body through the upper end piece to the outside, and the upper airbag is inflated or deflated through the upper pipeline; the lower airbag is connected to a lower pipeline, which extends upward from the inside of the main body through the upper end piece to the outside, and the lower airbag is inflated or deflated through the lower pipeline; A plurality of through holes are formed on the main body; the plurality of through holes are arranged along the length direction of the main body and communicate with the internal space of the main body; The upper end of the negative pressure pipeline extends to the outside, and the lower end of the negative pressure pipeline passes through the upper end sheet and communicates with the internal space of the main pipe; the negative pressure pipeline is used to suction the internal space of the main pipe and the collapsed space of the esophagus, so that the esophagus collapses in the collapsed space of the esophagus and stays away from the ablation area; A partition is formed in the main body, and the partition is formed along the length direction of the main body to divide the internal space of the main body into an independent first internal space and a second internal space; The negative pressure pipeline includes a first negative pressure pipeline and a second negative pressure pipeline; the first negative pressure pipeline is connected to the first internal space; the second negative pressure pipeline is connected to the second internal space; A portion of the through hole is communicated with the first internal space; another portion of the through hole is communicated with the second internal space; The first internal space corresponds to the direction of the ablation area; The upper end of the first negative pressure pipeline is further formed with a first contrast agent input port, and the upper end of the second negative pressure pipeline is further formed with a second contrast agent input port; the contrast agent is used to utilize the negative pressure of the internal space of the main body and the collapsed space of the esophagus to be sprayed onto the inner wall of the esophagus to display the internal contour of the esophageal wall under X-rays.

2. The esophageal thermal damage protection device according to claim 1, characterized in that: Also includes a wire guide tube; The wire guide tube is formed in the main body; the upper end of the wire guide tube passes through the upper end piece, and the lower end of the wire guide tube passes through the lower end piece; The guidewire tube is used to accommodate a guidewire, and the guidewire is used to guide the main tube to a predetermined position of the esophagus.

3. The esophageal thermal damage protection device according to claim 2, characterized in that: The upper part of the main tube body further comprises a handle, so as to adjust the angle and position of the main tube body in the esophagus through the handle.

4. The esophageal thermal damage protection device according to claim 3, characterized in that: The handle is formed at the upper end of the wire guide tube or the upper end of the main tube body.

5. The esophageal thermal damage protection device according to claim 2, characterized in that: A stopper is formed at the lower end of the guide wire.

6. The esophageal thermal damage protection device according to claim 5, characterized in that: The stopper is in an arc shape.

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