Single-balloon catheter with medicine injection and plugging compression functions and injection equipment

Abstract

The utility model relates to a single-balloon catheter with medicine injection and plugging compression functions and injection equipment, and is applied to the field of medical instruments. The device comprises a first pipe fitting, a balloon and a second pipe fitting, and the first pipe fitting comprises a first through hole; the balloon is communicated with the first pipe fitting and can stretch out and draw back in the radial direction to be matched with a pipe cavity for plugging the esophagus; the second pipe fitting penetrates through the first pipe fitting, the second pipe fitting comprises an administration channel and a second through hole, and the second through hole can be communicated with the first through hole and the administration channel; in the closed state, the first through hole and the second through hole do not coincide in the radial direction; in a working state, the first through hole and the second through hole are at least partially overlapped in the radial direction. After the single-balloon catheter is inserted into a corresponding position, the balloon expands to block the catheter cavity and fix the catheter to a diseased region, so that hormone medicine can be fully mixed and soaked with a wound surface above the balloon, the perfusion effect can be kept for a long time, and the clinical curative effect is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a single-balloon catheter and injection device having both drug injection and occlusion and compression functions. Background Art

[0002] Endoscopic submucosal dissection (ESD) refers to an endoscopic minimally invasive technique that uses various endoscopic electrosurgical cutters to perform submucosal dissection on early gastrointestinal lesions larger than 2 cm. This technique enables en bloc resection of larger lesions and provides accurate pathological diagnosis and staging of lesions.

[0003] Compared with traditional surgical operations, ESD can better preserve the physiological functions of the digestive tract on the basis of tumor removal, significantly improving the patient's quality of life after surgery. It has now become the preferred treatment for early digestive tract cancer and precancerous lesions including the esophagus.

[0004] A common complication after ESD surgery for large-area esophageal lesions is luminal stenosis, which is also a current clinical pain point. In order to solve this problem, the commonly used methods are: oral hormones, hormone injections, dilation, stents, etc., but their actual effects are uncertain and the repeatability is inconsistent.

[0005] Clinical studies have found that a short course of oral hormone therapy combined with hormone soaking has a better effect and can significantly reduce the incidence of esophageal stenosis. During the intracavitary hormone injection and soaking treatment, the gas in the stomach and esophageal cavities must first be sucked out, and then the drug diluent is injected into the esophageal cavity. However, due to the peristalsis of the lumen and possible choking, the retention time of the drug in the lumen is uncontrollable, affecting the treatment effect. Summary of the invention

[0006] Based on this, it is necessary to provide a single-balloon catheter and injection device with both drug injection and occlusion and compression functions to address the problem of uncontrollable drug retention time in the lumen during hormone diagnosis and treatment.

[0007] In the first aspect, the present application provides a single-balloon catheter with both drug injection and occlusion compression functions, which adopts the following technical solution:

[0008] A single-balloon catheter with both drug injection and blocking and compression functions comprises a first tube, a balloon and a second tube, wherein the first tube comprises a first through hole arranged on a side wall; the balloon is connected to the first tube, and the balloon is closer to the distal end of the first tube than the first through hole, and the balloon is configured to be able to expand and contract radially so that the balloon can adapt to block the lumen of the esophagus; the second tube is passed through the first tube, and the second tube comprises a drug delivery channel for delivering drugs, and a second through hole arranged on the side wall and connected to the drug delivery channel, and the second through hole can connect the first through hole and the drug delivery channel, thereby releasing drugs to the outside; wherein the single-balloon catheter with both drug injection and blocking and compression functions comprises a closed state and a working state: when in the closed state, the first through hole and the second through hole do not overlap in the radial direction; when in the working state, the first through hole and the second through hole at least partially overlap in the radial direction.

[0009] In one embodiment, the single-balloon catheter with both drug injection and occlusion compression functions also includes a limiter, the first tube has a built-in limiter groove extending longitudinally, the limiter is connected to the outer wall of the second tube and slidably installed in the limiter groove.

[0010] In one embodiment, the limit member includes a closed position and a plurality of opening positions spaced apart from the closed position, the closed position being correspondingly arranged at the distal end of the limit groove, and all the opening positions are spaced apart from each other from the distal end of the limit groove to the proximal end of the limit groove; wherein, when the single-balloon catheter having both the drug injection and the blocking and compression functions is in a closed state, the limit member switches to the closed position so that the drug is blocked in the second tube; when the single-balloon catheter having both the drug injection and the blocking and compression functions is in a working state, the limit member can switch to any of the opening positions, and the first through hole is connected to the second through hole so that the drug is released.

[0011] In one of the embodiments, the single-balloon catheter having both drug injection and occlusion compression functions further includes a plurality of opening ridges disposed in the limiting groove, the opening ridges being arranged corresponding to the opening positions, and in the radial direction of the first tube, the opening ridges being able to contact the limiting member.

[0012] In one embodiment, the balloon has a built-in filling cavity, and the first tube also includes a filling channel, which is connected to the filling cavity for injecting a filling medium into the filling cavity. As the volume of the injected filling medium changes, the balloon can expand and contract longitudinally.

[0013] In one embodiment, the balloon is made of elastic material, and the elastic material includes silicone, rubber and polyurethane materials.

[0014] In one embodiment, the single-balloon catheter with both drug injection and occlusion compression functions also includes a plurality of marks provided on the first tube member, the marks are located on the side of the balloon away from the distal end of the first tube member, and all of the marks are spaced apart longitudinally along the first tube member.

[0015] In one embodiment, the single-balloon catheter with both drug injection and occlusion and compression functions further includes a developing ring sleeved on the distal end of the first tube, and the developing ring is located on a side of the balloon close to the distal end of the first tube.

[0016] In one embodiment, the first through holes are arranged in plurality, and all the first through holes are distributed at intervals along the longitudinal direction of the first tube, and the second through holes are arranged in plurality corresponding to the first through holes.

[0017] In one embodiment, the first tube further includes a guidewire channel extending in the longitudinal direction, and the guidewire channel is used for passing a guidewire.

[0018] In a second aspect, the present application provides an injection device, which adopts the following technical solution:

[0019] An injection device comprises the above-mentioned single balloon catheter with both drug injection and occluding and compressing functions, an input component and a connecting component, wherein the input component comprises a plurality of input tubes, the input tubes are connected to the proximal end of the single balloon catheter with both drug injection and occluding and compressing functions, and the connecting component is arranged around the periphery of the connecting part between the input tubes and the single balloon catheter with both drug injection and occluding and compressing functions.

[0020] The above-mentioned single-balloon catheter with both drug injection and blocking and compression functions is always in a closed state before the injection operation, and the first through hole is not connected to the second through hole, so that the drug sealed inside the second tube is not easily contaminated by the outside world and reduces the efficacy. After the single-balloon catheter with both drug injection and blocking and compression functions is inserted into the corresponding position, the balloon expands to achieve blocking of the lumen and fix the catheter to the lesion site, and then switches to the working state. The drug inside the catheter is released through the first through hole and the second through hole, which ensures that the drug injected into the human body is as pollution-free and bacteria-free as possible, thereby improving the treatment effect.

[0021] Moreover, due to the setting of the balloon, the hormone drug can be fully mixed and soaked with the wound surface above the balloon, which can retain the perfusion effect for a long time and thus improve the clinical efficacy. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG1 is a partial schematic diagram of a single-balloon catheter having both drug injection and occlusion and compression functions in one embodiment of the present application.

[0023] FIG2 is a cross-sectional view along the AA direction of a single balloon catheter having both drug injection and occlusion and compression functions in one embodiment of the present application.

[0024] FIG3 is a cross-sectional view along the BB direction of a single balloon catheter having both drug injection and occlusion and compression functions in one embodiment of the present application.

[0025] FIG. 4 is a schematic diagram of an injection device in an embodiment of the present application.

[0026] Notes on the attached drawings:

[0027] 1. Single-balloon catheter with drug injection and occlusion compression functions; 11. First pipe; 111. Injection channel; 112. Filling channel; 113. Guidewire channel; 114. First through hole; 115. Limiting groove; 12. Second pipe; 121. Drug delivery channel; 122. Second through hole; 13. Limiting piece; 14. Opening ridge; 15. Balloon; 151. Filling cavity; 16. Marking; 17. Developing ring; 2. Input assembly; 21. Drug delivery pipe; 22. Filling pipe; 23. Guidewire pipe; 3. Connecting assembly; F1, longitudinal; F2, radial. DETAILED DESCRIPTION

[0028] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0029] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0030] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0031] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0032] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0033] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0034] It is particularly important to note that in the description of this application, those skilled in the art should understand that, unless otherwise clearly specified and limited, the terms "proximal end" and "distal end" are relative to the operator; the "proximal end" is the end of the endoscope operating handle that is closer to the user in one-dimensional direction when it is held and operated, and the "distal end" is the end of the endoscope operating handle that is farther away from the user in one-dimensional direction when it is held and operated. And those skilled in the art should understand that "far" and "near" do not refer to the three-dimensional space straight-line distance from the user.

[0035] Endoscopic submucosal dissection (ESD) refers to an endoscopic minimally invasive surgery that uses various endoscopic electrosurgical knives to perform submucosal dissection on early digestive tract lesions larger than 2 cm. This technology enables en bloc resection of larger lesions and provides accurate case diagnosis and staging for lesions.

[0036] Compared with traditional surgical operations, ESD can not only remove the tumor but also better preserve the physiological function of the digestive tract, thereby significantly improving the patient's quality of life after surgery. It has now become the preferred treatment for early digestive tract cancer and precancerous lesions including the esophagus.

[0037] A common complication after ESD surgery for large-area esophageal lesions is stenosis of the esophagus lumen, which is also one of the current clinical pain points. In order to solve this problem, the commonly used methods are: oral hormones, hormone injections, dilation, stent installation and other treatment options, but their actual effects are uncertain and repeatability cannot be guaranteed. Clinical studies published earlier have found that a short course of oral hormones combined with hormone immersion has a better effect and can significantly reduce the incidence of esophageal stenosis.

[0038] During the intracavitary hormone injection and immersion treatment process, the gas in the gastric cavity and esophageal cavity needs to be sucked out first, and then a certain amount of hormone diluent is injected into the esophageal cavity. However, due to the peristalsis of the lumen itself and the choking that may occur during the operation, the retention time of the drug in the lumen is uncontrollable, affecting the treatment effect.

[0039] Therefore, in order to solve the above problems, the present application provides a catheter that can block the lumen for a period of time to ensure that the drug is fully mixed and soaked in the wound surface, specifically a single-balloon catheter with both drug injection and blocking and compression functions.

[0040] The embodiments of the present application are further described in detail below in conjunction with Figures 1-4.

[0041] Referring to Figures 1 and 2, Figure 1 shows a partial schematic diagram of a single balloon catheter with both drug injection and occlusion compression functions in one embodiment of the present application, and Figure 2 shows a cross-sectional view of the single balloon catheter with both drug injection and occlusion compression functions in the AA direction in one embodiment of the present application. One embodiment of the present application provides a single balloon catheter 1 with both drug injection and occlusion compression functions, comprising a first tube 11 and a second tube 12 stacked in the first tube 11. The first tube 11 includes an injection channel 111 extending along the longitudinal direction F1, and the injection channel 111 passes through the end surface of the proximal end of the first tube 11 to form an insertion port for the second tube 12 to be inserted, and the second tube 12 is slidably installed in the injection channel 111 through the insertion port.

[0042] In the embodiment of the present application, in order to facilitate the sliding operation of the second pipe 12 in the injection channel 111, an oil film layer is coated on the inner wall of the injection channel 111 to reduce the friction resistance between the outer wall of the second pipe and the inner wall of the injection channel 111. The oil film layer can be common glycerin or other liquids with lubricating effect, which is not limited here.

[0043] In addition, in order to facilitate the smooth insertion of the single balloon catheter 1 with both drug injection and occlusion and compression functions into the natural cavity of the human body for drug administration, the first tube 11 and the second tube 12 in the embodiment of the present application are both made of flexible materials, specifically polyurethane materials.

[0044] As shown in Figure 3, Figure 3 shows a cross-sectional view of a single balloon catheter with both drug injection and occlusion compression functions in the BB direction in one embodiment of the present application. Specifically, the first tube 11 includes a first through hole 114 provided on the side wall, and the first through hole 114 is connected to the injection channel 111 along the radial direction F2, so as to connect the injection channel 111 to the outside.

[0045] The second tube 12 includes a drug delivery channel 121 and a second through hole 122 provided on the side wall, wherein the drug delivery channel 121 extends along the longitudinal direction F1 and penetrates the end surface of the proximal end of the second tube 12 to form a drug delivery port, and the drug is injected into the drug delivery channel 121 through the drug delivery port to achieve transmission. The second through hole 122 is connected to the drug delivery channel 121 along the radial direction F2, so as to connect the drug delivery channel 121 to the first through hole 114, thereby releasing the drug to the outside to achieve the treatment operation.

[0046] In the embodiment of the present application, the drug can be a hormone solution. It is understandable that in some other embodiments, the drug can also be other types of medicaments, which can be adaptively selected according to the actual operation conditions, and the present application does not limit the type of drug.

[0047] As shown in combination with Figures 2 and 3, in some embodiments, the single-balloon catheter 1 with both drug injection and occluding and compressing functions includes a closed state and a working state. When drug injection is not needed, the single-balloon catheter 1 with both drug injection and occluding and compressing functions remains in a closed state, and its interior is isolated from the outside world. The drug stored in the catheter is not easily polluted by air, so that the efficacy of the drug can be guaranteed.

[0048] After the single-balloon catheter 1 with both drug injection and occluding and compressing functions is inserted into the human body, it is switched to the working state. At this time, the drug solution inside the single-balloon catheter 1 with both drug injection and occluding and compressing functions flows out of the catheter and directly contacts the lesion site. The possibility of the drug being contaminated by the outside world is small, which ensures that the drug injected into the human body is pollution-free and bacteria-free as much as possible, thereby improving the treatment effect.

[0049] In the embodiment of the present application, when the single-balloon catheter 1 with both drug injection and blocking and compression functions is in a closed state, the distal end of the first through hole 114 contacts the distal end of the second through hole 122, and the first through hole 114 and the second through hole 122 do not overlap in the radial direction F2, that is, the second through hole 122 is blocked by the side wall of the first tube 11, so that the drug solution is isolated in the drug administration channel 121 to avoid contact with the outside world and contamination.

[0050] When the single-balloon catheter 1 with both drug injection and occlusion and compression functions is in working state, there is at least partial overlap between the first through hole 114 and the second through hole 122 in the radial direction F2, so that the drug injected into the drug delivery channel 121 can flow to the outside through the second through hole 122 and the first through hole 114 in turn, thereby completing the drug delivery operation to the lesion site.

[0051] In addition, as the second tube 12 slides in the first tube 11 , the area of ​​the overlapped portion between the first through hole 114 and the second through hole 122 will also change, thereby achieving control of the drug flow to meet the different drug delivery requirements of different patients.

[0052] Continuing to refer to FIG. 3 , in some embodiments, in order to further ensure the smoothness of switching between the closed state and the working state of the single-balloon catheter 1 with both drug injection and occluding and compression functions, the single-balloon catheter 1 with both drug injection and occluding and compression functions also includes a limiter 13, and the limiter 13 is bonded or integrally formed on the outer wall of the second tube 12. As shown in FIG. 3 , the limiter 13 is connected to the second tube 12 by bonding.

[0053] Specifically, a limit groove 115 is arranged in the first tube 11 and extends along the longitudinal direction F1. The limit member 13 is slidably installed in the limit groove 115. The side wall of the limit member 13 contacts the groove wall of the limit groove 115 to limit the circumferential position of the second tube 12, so that the second tube 12 is not easy to twist in the first tube 11, so that the first through hole 114 and the second through hole 122 can at least partially overlap in the circumferential direction during the sliding process of the second tube 12, thereby ensuring that the single balloon catheter 1 with both drug injection and blocking and compression functions can switch freely between a closed state and a working state.

[0054] Continuing to refer to FIG. 2 and FIG. 3 , the limiter 13 includes a closed position and a plurality of opening positions spaced apart from the closed position. The closed position is correspondingly arranged at the distal end of the limiter groove 115. When the limiter 13 is in the closed position, the first through hole 114 and the second through hole 122 are staggered from each other in the radial direction F2, and the drug solution is blocked in the drug delivery channel 121. The plurality of opening positions are arranged on one side of the closed position close to the proximal end of the limiter groove 115, and all the closed positions are spaced apart from the distal end of the limiter groove 115 to the proximal end of the limiter groove 115.

[0055] In the embodiment of the present application, adjacent opening positions are equally spaced so that the operator can monitor the drug injection efficiency corresponding to the current opening in real time according to the opening position. In other embodiments, the spacing between adjacent opening positions can also be unequal to meet the different drug administration requirements of different treatment processes.

[0056] Furthermore, in order to facilitate the operator to perceive the real-time position of the limiter 13, in some embodiments, the single-balloon catheter 1 with both drug injection and occlusion compression functions also includes a plurality of opening ridges 14 arranged in the limiter groove 115, and the opening ridges 14 are arranged one-to-one corresponding to the above-mentioned opening positions.

[0057] In the embodiment of the present application, there are three opening ribs 14, which are evenly distributed in the limiting groove 115 from the distal end to the proximal end of the limiting groove 115 and connected to the groove wall of the limiting groove 115 on the side away from the limiting member 13. In the embodiment of the present application, the opening ribs 14 can be connected to the first pipe member 11 by bonding or integral molding. The connection shown in FIG3 is only achieved by bonding. It can be understood that in some other embodiments, the opening ribs 14 and the first pipe member 11 can also be constructed into an integral structure.

[0058] Specifically, on the radial direction F2 of the first pipe fitting 11, there is at least partial overlap between the opening ridge 14 and the limit member 13, that is, during the sliding of the second pipe fitting 12, the end of the limit member 13 can collide with the end of the opening ridge 14. During actual operation, the operator can determine the size of the connecting area between the first through hole 114 and the second through hole 122 by counting the number of times the operator feels the pulling resistance when pulling out the second pipe fitting 12.

[0059] It is worth noting that in the embodiment of the present application, the opening ridge 14 and the limiter 13 are also made of flexible material to ensure that they can be elastically deformed when there is partial overlap in the radial direction F2, so that the second pipe 12 can slide smoothly.

[0060] Specifically referring to FIG. 3 , in the embodiment of the present application, three opening ridges 14 are specifically provided, and the three opening ridges 14 are evenly distributed along the extension direction of the limiting groove 115 , and the opening ridges 14 and adjacent opening ridges 14 or the groove walls of the limiting groove 115 define different openings between the first through hole 114 and the second through hole 122 .

[0061] Specifically, the openings from the distal end to the proximal end of the limiting groove 115 are set to 33%, 66% and 100% respectively to meet the different injection volume requirements of different patients. It is understandable that in some other embodiments, more opening positions can be set and more opening ridges 14 can be arranged accordingly to improve the accuracy of drug delivery rate regulation.

[0062] Referring to FIG. 1 , in some embodiments, the single-balloon catheter 1 with both drug injection and blocking and compression functions further includes a balloon 15 mounted on the first tube 11, and the balloon 15 is closer to the distal end of the first tube 11 than the first through hole 114. In the embodiment of the present application, the balloon 15 is configured to be able to retract along the radial direction F2, so as to be clamped and fixed to the lesion site of the patient, so as to achieve the fixation of the single-balloon catheter 1 with both drug injection and blocking and compression functions. Specifically, a filling cavity 151 is provided in the balloon 15, and a filling channel 112 is also provided in the first tube 11 along the longitudinal direction F1, and the filling channel 112 is arranged at intervals from the injection channel 111. Among them, the filling channel 112 is connected to the filling cavity 151, so as to be used for injecting a filling medium into the filling cavity 151, and the diameter of the balloon 15 changes with the change in the volume of the injected filling medium. Among them, the balloon 15 and the first tube 11 are integrally formed and arranged, thereby improving the air tightness of the balloon 15.

[0063] In the embodiment of the present application, the filling material can be any one of liquid or gas. The balloon 15 is made of elastic material, specifically any one of silicone, rubber and polyurethane materials, as long as it can facilitate the change of the size of the balloon 15 in the radial direction F2. In addition, the diameter of the balloon 15 is set to 15mm or 20mm to adapt to the diameter requirements of the natural cavity of the human body.

[0064] During the actual diagnosis and treatment process, the patient lies on his back at an angle of about 45°, and the single-balloon catheter 1 with both drug injection and occluding and compressing functions is inserted into the lumen through the endoscopic biopsy channel, and the distal end of the single-balloon catheter 1 with both drug injection and occluding and compressing functions is sent to the bottom of the ESD wound surface, and a filling medium is injected into the balloon 15 to inflate the balloon 15 and then fix it at this position, and then the single-balloon catheter 1 with both drug injection and occluding and compressing functions is switched to the working state, and the drug (here specifically refers to the diluted hormone solution) is released into the cavity, so that the drug can be fully mixed and soaked above the balloon and on the wound surface, so that the drug can maintain effective contact with the wound surface for a long time, thereby achieving precise treatment of the lesion site, reducing the amount of drug injection required for a single injection treatment, and improving clinical efficacy.

[0065] In addition, the single balloon catheter 1 with both drug injection and occlusion and compression functions can also be used for patients with esophageal varicose bleeding. Esophageal varicose bleeding caused by portal hypertension is a clinical emergency and severe disease. The balloon 15 can be used to compress and stop bleeding due to ruptured blood vessels or pinhole bleeding after endoscopic injection of sclerosant. The balloon 15 plays the role of occluding and compressing blood vessels to stop bleeding, which can buy time for the next step of treatment.

[0066] In some other embodiments, as shown in FIG1 , the first through hole 114 and the second through hole 122 can be provided in plurality, and the first through holes 114 and the second through holes 122 are arranged one by one. Along the longitudinal direction F1 of the first tube 11, all the first through holes 114 are distributed at intervals to ensure that the drug sealed in the single balloon catheter 1 with both drug injection and blocking and compression functions can be released smoothly, thereby improving the operational reliability.

[0067] In the embodiment of the present application, only two first through holes 114 and two second through holes 122 are provided as an example for illustration, and the two first through holes 114 are respectively provided at 3 cm and 5 cm proximal to the balloon 15 .

[0068] Continuing to refer to FIG. 1 , in some embodiments, the single-balloon catheter 1 with both drug injection and occlusion compression functions further includes a plurality of marks 16 disposed on the periphery of the first tube 11, and the marks 16 are arranged at intervals from the first through hole 114. The marks 16 in the present application are specifically marker marks, and the marks 16 are located on the side of the balloon 15 away from the first tube 11, and all the marks 16 are spaced apart along the longitudinal direction F1 of the first tube 11, so that the operator can confirm the position to be injected according to the marks 16.

[0069] In some other embodiments, the single-balloon catheter 1 with both drug injection and occlusion and compression functions also includes a developing ring 17 sleeved on the distal end of the first tube 11. The developing ring 17 is located on the side of the balloon 15 close to the distal end of the first tube 11. The developing ring 17 is used to mark 16 the irradiation range of the proton beam to assist the operator in determining the location of the lesion.

[0070] As shown in Figure 2, in some embodiments, the first tube 11 also includes a guidewire channel 113 extending along the longitudinal direction F1. The guidewire channel 113 is arranged at intervals from the above-mentioned injection channel 111 and the filling channel 112. The guidewire channel 113 is used for passing the guidewire to facilitate guiding the single balloon catheter 1 with both drug injection and occlusion and compression functions to the desired location as a whole, thereby achieving precise treatment.

[0071] In combination with Figures 1 to 4, Figure 4 shows a schematic diagram of an injection device in an embodiment of the present application. In some embodiments, the present application also provides an injection device, including a single balloon catheter 1 with both drug injection and occlusion and compression functions as shown in any of the above embodiments, and an input component 2 connected to the single balloon catheter 1 with both drug injection and occlusion and compression functions.

[0072] Specifically, the input component 2 includes a plurality of input tubes. In the embodiment of the present application, the input tubes are set to three corresponding to the number of cavities in the first tube 11 and the second tube 12, namely, a drug administration tube 21 for connecting the drug administration channel 121, a filling tube 22 for connecting the filling channel 112, and a guidewire tube 23 for connecting the guidewire channel 113, so as to facilitate the operation of the single balloon catheter 1 with both drug injection and occlusion and compression functions.

[0073] In addition, in some other embodiments, the injection device also includes a connecting component 3 arranged at the connecting portion between the input tube and the single balloon catheter 1 with both drug injection and blocking and compression functions, the connecting component 3 includes a accommodating cavity (not shown), and all distal portions of the input tube and the proximal portion of the single balloon catheter 1 with both drug injection and blocking and compression functions are accommodated in the accommodating cavity, thereby achieving effective protection of the connecting portion between the single balloon catheter 1 with both drug injection and blocking and compression functions and the input tube, thereby extending the service life of the injection device.

[0074] In some other embodiments, the present application further provides an operation method of a single balloon catheter 1 with both drug injection and occlusion and compression functions, which is applied to the single balloon catheter 1 with both drug injection and occlusion and compression functions shown in any of the above embodiments, and the operation method specifically includes the following operation steps:

[0075] S1: a single balloon catheter 1 with both drug injection and occlusion and compression functions is introduced into the human body with the aid of an endoscope;

[0076] S2: Determine the injection site under endoscopic imaging observation;

[0077] S3: injecting a filling medium into the balloon 15 to expand the balloon 15 so as to be fixed at the injection position;

[0078] S4: Injecting drugs into the human body;

[0079] S5: leaving the drug in the human body for at least a predetermined period of time;

[0080] S6: withdraw the injected drug;

[0081] S7: extract the filling medium and take out the single-balloon catheter 1 with both drug injection and occlusion and compression functions.

[0082] Among them, in step S1, the patient is required to lie on his back at an angle of about 45° before the operation, and a single balloon catheter 1 with both drug injection and occlusion and compression functions is inserted into the endoscope channel, and the single balloon catheter 1 with both drug injection and occlusion and compression functions is delivered into the human body with the help of an endoscope.

[0083] In step S2, the site that needs injection, that is, the lesion site, is determined under endoscopic image observation, and the location that needs injection is confirmed based on the marker.

[0084] In step S5, the preset time is set to 10 minutes. In actual operation, the preset time may be increased or decreased according to different patient conditions, as long as the drug is ensured to be fully absorbed by the human body.

[0085] In step S6, after the treatment is completed, the drug injected into the natural cavity of the human body is reversely withdrawn through the drug delivery channel 121 to prevent the patient from aspirating after the operation.

[0086] In step S7 , the filling medium is withdrawn to deflate the balloon 15 , and the endoscopic channel is pushed out.

[0087] During the above operation, the operator can observe the surgical injection process under direct vision, control the drug injection volume according to the marker, and observe the condition of the target tissue after the drug is administered.

[0088] Step S4 specifically includes the following steps:

[0089] S41: switching the single balloon catheter 1 with both drug injection and occlusion and compression functions from a closed state to a working state;

[0090] S42: Select the opening position according to the injection requirements;

[0091] S43: The limiting member 13 is switched to a corresponding opening position;

[0092] S44: The drug is released into the human body.

[0093] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0094] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A single-balloon catheter with both drug injection and occlusion compression functions, characterized in that: include: A first pipe member (11) comprising a first through hole (114) provided on a side wall; a balloon (15) connected to the first tube (11), the balloon (15) being closer to the distal end of the first tube (11) than the first through hole (114), the balloon (15) being configured to be able to expand and contract along a radial direction (F2), so that the balloon (15) can adapt to block the lumen of the esophagus; and a second tube (12) inserted into the first tube (11), the second tube (12) comprising a drug delivery channel (121) for delivering drugs, and a second through hole (122) provided on the side wall and connected to the drug delivery channel (121), the second through hole (122) being able to connect the first through hole (114) and the drug delivery channel (121), thereby releasing the drugs to the outside; The single balloon catheter (1) having both drug injection and occlusion compression functions comprises a closed state and a working state: when in the closed state, the first through hole (114) and the second through hole (122) do not overlap in the radial direction (F2); when in the working state, the first through hole (114) and the second through hole (122) at least partially overlap in the radial direction (F2).

2. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The single-balloon catheter (1) having both drug injection and occlusion compression functions further comprises a limiting member (13); the first tube (11) is provided with a limiting groove (115) extending in the longitudinal direction (F1); the limiting member (13) is connected to the outer wall of the second tube (12) and is slidably mounted in the limiting groove (115).

3. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 2, characterized in that: The limiting member (13) comprises a closed position and a plurality of opening positions spaced apart from the closed position, the closed position being arranged correspondingly at the distal end of the limiting groove (115), and all the opening positions are spaced apart from the distal end of the limiting groove (115) to the proximal end of the limiting groove (115); Wherein, when the single-balloon catheter (1) having both drug injection and blocking and compression functions is in a closed state, the limiting member (13) switches to the closed position, so that the drug is sealed in the second tube (12); When the single-balloon catheter (1) having both drug injection and blocking and compression functions is in a working state, the limiter (13) can be switched to any of the opening positions, and the first through hole (114) is connected to the second through hole (122), so that the drug is released.

4. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 3, characterized in that: The single-balloon catheter (1) having both drug injection and occlusion compression functions further comprises a plurality of opening ridges (14) arranged in the limiting groove (115); the opening ridges (14) are arranged corresponding to the opening positions; in the radial direction (F2) of the first tube (11), the opening ridges (14) can contact the limiting member (13).

5. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The balloon (15) has a built-in filling cavity (151), and the first tube (11) also includes a filling channel (112). The filling channel (112) is connected to the filling cavity (151) so as to be used for injecting a filling medium into the filling cavity (151). As the volume of the injected filling medium changes, the balloon (15) can expand and contract in the longitudinal direction (F1).

6. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 5, characterized in that: The balloon (15) is made of elastic material, and the elastic material includes silicone, rubber and polyurethane materials.

7. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The single-balloon catheter (1) having both drug injection and occlusion and compression functions further comprises a plurality of marks (16) arranged on the first tube (11), wherein the marks (16) are located on a side of the balloon (15) away from the distal end of the first tube (11), and all of the marks (16) are arranged at intervals along the longitudinal direction (F1) of the first tube (11).

8. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The single-balloon catheter (1) having both drug injection and occlusion and compression functions further comprises a developing ring (17) sleeved on the distal end of the first tube (11); the developing ring (17) is located on a side of the balloon (15) close to the distal end of the first tube (11).

9. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The first through holes (114) are arranged in plurality, and along the longitudinal direction (F1) of the first pipe (11), all the first through holes (114) are distributed at intervals, and the second through holes (122) are arranged in plurality corresponding to the first through holes (114).

10. The single-balloon catheter with both drug injection and occlusion and compression functions according to claim 1, characterized in that: The first tube (11) further comprises a guidewire channel (113) extending in the longitudinal direction (F1), wherein the guidewire channel (113) is used for passing a guidewire.

11. An injection device, characterized in that: The injection device comprises: A single-balloon catheter (1) having both drug injection and occlusion and compression functions as claimed in any one of claims 1 to 10; An input assembly (2) comprising a plurality of input tubes, wherein the input tubes are connected to the proximal end of the single balloon catheter (1) having both drug injection and occlusion and compression functions; and The connection component (3) is arranged around the periphery of the connection part between the input tube and the single balloon catheter (1) having both the drug injection and blocking and compression functions.

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