Gallstone removing system

Abstract

The invention provides a gallstone removing system, which relates to the technical field of medical equipment and comprises a drainage catheter, an expansion stent and a plurality of transducers, the drainage catheter penetrates through the expansion stent; the drainage catheter is sequentially provided with a first drainage opening, a buckle, a three-way opening, a wire connector and a second drainage opening in the first direction. A plurality of equipment side holes for embedding each transducer and a plurality of drainage holes for accelerating drainage are formed in the side wall of the drainage catheter at one end of the second drainage opening; a drainage cavity and a wire cavity which are parallel to each other are arranged in the drainage catheter; the equipment side hole is communicated with the wire cavity, and the drainage hole is communicated with the drainage cavity. By means of the design, the defects under the limitation of large calculus removal and gallbladder tube dissection in the prior art are effectively overcome, and gallbladder injuries, calculus relapse and operation risks are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a gallbladder stone removing system. BACKGROUND

[0002] The prevalence of gallbladder stones in the adult population in China is 2.3%-6.5%, and the complications caused by gallbladder stones, such as biliary colic, acute cholecystitis and biliary pancreatitis, significantly increase the medical burden. The current mainstream treatment method, cholecystectomy, has a 10%-40% incidence of postoperative syndrome, which is manifested as persistent abdominal pain and indigestion, accompanied by biliary fistula, bleeding and other surgical risks. In order to preserve the structure and function of the gallbladder, the medical community has developed drug dissolution, extracorporeal shock wave lithotripsy and laparoscopic gallbladder-preserving stone removal surgery: the drug dissolution has low dissolution efficiency for bile pigments and mixed stones; extracorporeal shock wave lithotripsy has low stone removal rate, and residual fragments can easily cause bile duct obstruction and biliary pancreatitis, so it has been withdrawn from clinical use; laparoscopic gallbladder-preserving stone removal surgery needs to cut open the gallbladder wall, and the 10-year stone recurrence rate is as high as 41.46%, and there is a risk of gallbladder cancer.

[0003] The peroral cholangioscopy technology developed in recent years can achieve superselection of the cystic duct and removal of sand-like stones, but it is limited by the anatomical structure of the cystic duct (about 3mm), and cannot directly remove larger stones. The existing stone crushing equipment (such as hydroelectricity / holmium laser) has the risk of gallbladder damage and perforation, and the mechanical stone removal process has the possibility of stone escape. Therefore, developing a miniaturized treatment system that adapts to natural cavities and can synergistically improve the stone removal efficiency is a technical problem that needs to be solved in current clinical practice.

[0004] As described above, the existing technologies such as drug dissolution, extracorporeal shock wave lithotripsy and laparoscopic gallbladder-preserving stone removal surgery have poor stone removal effect, high recurrence rate, high surgical risk, and difficulty in handling large stones, especially under the anatomical limitations of the cystic duct, it is difficult to completely remove the stones. SUMMARY

[0005] In order to solve the technical problems of the existing technologies such as drug dissolution, extracorporeal shock wave lithotripsy and laparoscopic gallbladder-preserving stone removal surgery, such as poor stone removal effect, high recurrence rate, high surgical risk, and difficulty in handling large stones, especially under the anatomical limitations of the cystic duct, it is difficult to completely remove the stones, the present application provides a gallbladder stone removing system.

[0006] The technical scheme provided by the embodiments of the present application is as follows: First aspect: The gallbladder stone removing system provided by the embodiments of the present application comprises a drainage catheter, a dilating stent and a plurality of transducers. The drainage catheter penetrates the dilating stent. The drainage catheter is sequentially provided with a first drainage port, a buckle, a three-way port, a wire joint and a second drainage port in a first direction; A plurality of device side holes for embedding each of the transducers and a plurality of drainage holes for accelerating drainage are arranged on the side wall of the drainage catheter at one end of the second drainage port; The drainage catheter is internally provided with a drainage cavity and a wire cavity in parallel with each other; The device side hole is in communication with the wire cavity, and the drainage hole is in communication with the drainage cavity.

[0007] The technical scheme provided by the embodiment of the present application has at least the following beneficial effects: In the embodiment of the present application, the combination of drainage catheter, expansion stent and multiple transducers is adopted. The drainage cavity and the wire cavity are arranged in parallel in the drainage catheter, which ensures that there is no problem of poor drainage during the process of removing stones. The multiple device side holes of the side wall of the drainage catheter are in communication with the wire cavity, which can embed multiple transducers to realize accurate energy transmission and enhance the removal effect of stones. The multiple drainage holes help to accelerate the flow of liquid in the gallbladder and improve the removal of stones. In particular, the buckle, three-way port and other designs on the drainage catheter not only ensure the stable positioning of the system in the gallbladder, but also facilitate the connection with external devices, improve the operability and safety during the treatment process. These designs effectively overcome the shortcomings of the prior art in removing large stones and the anatomical limitations of the cystic duct, reducing the risk of gallbladder damage, stone recurrence and surgery. BRIEF DESCRIPTION OF DRAWINGS

[0008] In order to more clearly illustrate the technical scheme in the embodiments of the present application, the drawings needed in the embodiment description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0009] Figure 1 A structural schematic diagram of a gallbladder stone removal system provided by the embodiment of the present application; Figure 2 A sectional structure schematic diagram of the end of a first drainage catheter provided by the embodiment of the present application; Figure 3 A sectional structure schematic diagram of the end of a second drainage catheter provided by the embodiment of the present application; Figure 4 A sectional structure schematic diagram of a third drainage catheter provided by the embodiment of the present application; Figure 5 A wiring structure schematic diagram of a transducer and a temperature sensor provided by the embodiment of the present application; Figure 6A structure schematic diagram of the expansion stent provided by the embodiment of the present application; Figure 7 A structure schematic diagram of another gallbladder stone removing system provided by the embodiment of the present application.

[0010]

Reference signs

[0011] 1, drainage catheter; 101, first drainage port; 102, buckle; 103, three-way port; 104, lead connector; 105, second drainage port; 106, device side hole; 107, drainage hole; 108, drainage cavity; 109, lead cavity; 2, expansion stent; 3, transducer; 4, power supply; 5, temperature sensor. DETAILED DESCRIPTION

[0012] The technical solutions in the present application will be described below with reference to the drawings.

[0013] In the embodiments of the present application, the words such as "example", "for example" are used to represent as an example, illustration or description. Any embodiment or design scheme described as "example" in the present application should not be interpreted as more preferred or more advantageous than other embodiments or design schemes. Rather, the word "example" is intended to present the concept in a specific manner. In addition, in the embodiments of the present application, the meaning expressed by "and / or" can be both, or can be one of the two.

[0014] In the embodiments of the present application, "image" and "picture" can be used interchangeably at times. It should be pointed out that when the distinction is not emphasized, the meanings expressed are consistent. "Of", "corresponding" and "corresponding" can be used interchangeably at times. It should be pointed out that when the distinction is not emphasized, the meanings expressed are consistent.

[0015] In the embodiments of the present application, sometimes the subscript such as W1 can be mistakenly used in the form of non-subscript such as W1. When the distinction is not emphasized, the meanings expressed are consistent.

[0016] In order to make the technical problems, technical solutions and advantages to be solved by the present application more clear, the following will be described in detail with reference to the drawings and specific embodiments.

[0017] Reference is made to the accompanying drawings in the description of the specification Figure 1 , a structure schematic diagram of a gallbladder stone removing system provided by the embodiment of the present application is shown.

[0018] Reference is made to the accompanying drawings in the description of the specification Figure 2 , a cross-sectional structure schematic diagram of the end of a first drainage catheter provided by the embodiment of the present application is shown.

[0019] Reference is made to the accompanying drawings in the description of the specificationFigure 3 Figure 6 shows a cross-sectional structure of the end of the drainage catheter provided by the embodiment of the present application.

[0020] Referring to the drawings accompanying the specification Figure 4 Figure 7 shows a cross-sectional structure of the drainage catheter provided by the embodiment of the present application.

[0021] Referring to the drawings accompanying the specification Figure 5 Figure 8 shows a wiring structure of a transducer and a temperature sensor provided by the embodiment of the present application.

[0022] Referring to the drawings accompanying the specification Figure 6 Figure 9 shows a structure of a stent provided by the embodiment of the present application.

[0023] Referring to the drawings accompanying the specification Figure 7 Figure 10 shows a structure of another gallbladder stone removal system provided by the embodiment of the present application.

[0024] Figure 7 Figure 11 shows the overall connection relationship of the entire gallbladder stone removal system, which is conceived to place a duodenal papilla support device, i.e., a stent 2, under a duodenoscope, to enter through the duodenal papilla-choledochus-gallbladder duct, to superselect the gallbladder duct under the guidance of a peroral cholangioscope, and to place a nasobiliary tube into the gallbladder cavity along a guide wire. The system is placed to perform ultrasonic lithotripsy while infusing a drug to dissolve stones, and the <2mm stone fragments generated can be directly removed by negative pressure suction, and part of the residual fragments can be naturally discharged into the intestinal tract through the duodenal papilla support device, and subsequent peroral cholangioscopy can be performed under direct vision to completely flush and suction the residual stone fragments, so as to ensure complete removal of the stones.

[0025] The embodiment of the present application provides a gallbladder stone removal system, which comprises a drainage catheter 1, a stent 2 and a plurality of transducers 3. The drainage catheter 1 penetrates the stent 2. The drainage catheter 1 is sequentially provided with a first drainage port 101, a buckle 102, a three-way port 103, a guide wire connector 104 and a second drainage port 105 in a first direction. A plurality of device side holes 106 for embedding each of the transducers 3 and a plurality of drainage holes 107 for accelerating drainage are arranged on the side wall of the drainage catheter at one end of the second drainage port 105. The drainage catheter 1 is internally provided with a drainage cavity 108 and a guide wire cavity 109 which are parallel to each other. The device side hole 106 is in communication with the guide wire cavity 109, and the drainage hole 107 is in communication with the drainage cavity 108.

[0026] The drainage catheter 1 is the main component of the system and runs through the entire gallstone removal device. It connects and guides the flow of liquid in the gallbladder, helping to remove the stones. The purpose of implanting the temporary expansion stent 2 is to expand the sphincter of the duodenal papilla, provide sufficient operating space for the operation of the choledochoscope, and avoid sphincterotomy, thereby effectively protecting the physiological function of the sphincter. During the process of gallstone lithotripsy and dissolution, gallstone fragments may flow out of the cystic duct and become embedded in the duodenal papilla, causing cholangitis or biliary pancreatitis. By placing a duodenal papilla expansion stent, the gallstone fragments can flow out smoothly, minimizing complications caused by the operation. That is, the use of a drainage tube or a duodenal papilla support device prevents complications caused by the embedding of stone fragments, and avoids bile duct obstruction and pancreatitis caused by stone fragments. The transducer 3 is responsible for transmitting energy into the gallbladder, which is used to break up stones and accelerate the dissolution of gallstones to facilitate their removal. The first drainage port 101 and the second drainage port 105 are located at both ends of the drainage catheter, respectively, and are responsible for the discharge of liquid or stones in the gallbladder, ensuring the normal drainage of fluid in the gallbladder. The buckle 102 is used to fix the device in the right position to prevent displacement during treatment. The three-way port 103 connects external devices, providing an interface between the system and external devices, ensuring data transmission or energy input during treatment. The wire connector 104 connects the transducer and the wire, transmits energy, and ensures that the transducer can work normally. The device side hole 106 is located on the side wall of the drainage catheter and is used to embed multiple transducers, ensuring accurate positioning and operation of the transducers. The drainage hole 107 is provided on the drainage catheter to help accelerate the discharge of liquid and facilitate the removal of stones. The drainage lumen 108 is responsible for guiding the flow of liquid in the gallbladder, while the wire lumen 109 is used to transmit the energy required by the transducer.

[0027] Specifically, the gallbladder stone removal system of the present application optimizes the stone removal process through the synergistic effect of the drainage catheter, expansion stent and multiple transducers. The multiple drainage holes and device side holes of the drainage catheter help to promote the drainage of liquid and the accurate positioning of the transducers, making the stones more effectively removed. The expansion stent provides sufficient operating space for the operation of the choledochoscope, protects the physiological function of the sphincter of the duodenal papilla, and avoids complications caused by the embedding of stone fragments. The design of the system enables the stones in the gallbladder to be broken and discharged in a shorter time, while reducing the risk of gallbladder damage, surgery and stone recurrence. Through the setting of the wire connector and the three-way port, the external device can be seamlessly connected with the system, improving the convenience and safety of the operation. Overall, the system solves the shortcomings of traditional treatment methods in stone removal effect, recurrence rate and surgical safety.

[0028] The technical scheme provided by the embodiment of the present application brings at least the following beneficial effects: In the embodiment of the present application, a combination design of drainage catheter, expansion stent and multiple transducers is adopted. The drainage catheter is provided with parallel drainage cavities and wire cavities, which can ensure that there is no poor drainage problem during the process of removing stones. The multiple device side holes on the side wall of the drainage catheter are in communication with the wire cavities, and multiple transducers can be embedded to achieve precise energy transmission and enhance the removal effect of stones. Multiple drainage holes can help to accelerate the flow of liquid in the gallbladder and improve the removal of stones. In particular, the buckle, three-way port and other designs on the drainage catheter not only ensure the stable positioning of the system in the gallbladder, but also facilitate the connection with external equipment, improving the operability and safety during the treatment process. These designs effectively overcome the shortcomings of the prior art in removing larger stones and the anatomical limitations of the cystic duct, reducing gallbladder damage, stone recurrence and surgical risk.

[0029] In one possible implementation, the stone-dissolving drug of the gallbladder stone removal system is specifically a d-limonene mixed preparation prepared from 97% d-limonene, 2.1% polysorbate-80 and 0.9% sorbitan monooleate.

[0030] It should be noted that d-limonene as the main component has the effect of dissolving stones in the gallbladder, and polysorbate-80 and sorbitan monooleate as surfactants can help the solvent form an emulsion with the water remaining in the gallbladder, so that the reagent can more fully contact the stones, helping the drug to more effectively dissolve the stones and improve the treatment effect. The formula of the mixed preparation can enhance the stone-dissolving effect of the drug in the gallbladder.

[0031] Specifically, the use of d-limonene mixed preparation (97% d-limonene, 2.1% polysorbate-80, 0.9% sorbitan monooleate) is mainly based on the following three aspects: First, from the safety point of view, d-limonene as a monoterpene compound naturally existing in citrus fruits has low toxicity and good safety. Polysorbate-80 and sorbitan monooleate as food-grade emulsifiers have been widely verified for their safety. Second, in terms of stone-dissolving effect, d-limonene has a significantly better dissolution capacity for cholesterol stones than cholic acid preparations, and is comparable to organic solvents such as chloroform and diethyl ether. Although its stone-dissolving efficiency is slightly lower than that of methyl tert-butyl ether, it has a better safety advantage.

[0032] The mixed reagent can theoretically improve the dissolution effect: it is difficult to ensure that the gallbladder is completely filled with solvent by injecting d-limonene through the catheter, and due to the limitation of the hydrophobicity of d-limonene, in most cases, the density of the stone > bile > d-limonene, so the stone will sink in the lower layer, resulting in that the stone cannot be completely contacted with the solvent. The mixed reagent can form a stable oil-in-water (O / W) emulsion with water, which significantly improves the dispersibility of the stone dissolving agent in the bile, so that it can fully contact the surface of the stone. In addition, the principle of ultrasonic lithotripsy is cavitation, the addition of surfactant reduces the surface tension of the system and increases the number of cavitation nuclei, which can reduce the cavitation threshold, thereby improving the efficiency of ultrasonic lithotripsy. Due to the hydrophobicity of d-limonene, it is not miscible with water, and the stone sinks in the lower layer of water due to the density difference, and the contact with the reagent is limited. Form a stable oil-in-water (O / W) emulsion, and the stone is fully contacted with the reagent.

[0033] More specifically, the proportion of the d-limonene mixed preparation is as follows: Emulsifier (polysorbate-80 + sorbitan monooleate): The characteristics of polysorbate-80: hydrophilic dominant: HLB value is about 15 (strong hydrophilicity), suitable for forming oil-in-water (O / W) emulsion. Its molecular structure contains polyoxyethylene chain and polyhydroxy, which can effectively reduce the surface tension of the water phase and promote the dispersion of d-limonene (hydrophobic) in water. The characteristics of sorbitan monooleate: HLB value is about 4.3 (strong lipophilicity), mainly as a co-emulsifier. Its hydrophobic chain (oleate) can be anchored at the oil droplet interface, and it can synergistically enhance the interface film strength with polysorbate-80 to prevent emulsion coalescence. The ratio of polysorbate-80 to sorbitan monooleate is between 7:3 and 9:1, which can make the mixed HLB value close to 10-12, which is the ideal range of O / W emulsion (HLB 8-18).

[0034] The ratio of emulsifier to d-limonene is 3%-5%. If the proportion of emulsifier is too high: mucous membrane irritation, biological safety is reduced. If the proportion of emulsifier is too high, the high viscosity will cause the cavitation threshold to rise, and the ultrasonic cavitation effect will decrease, thereby reducing the stone dissolution efficiency. If the proportion of emulsifier is too low: the stability of the emulsion is insufficient, and the oil droplets are easy to coalesce, resulting in stratification.

[0035] In one possible implementation, the expanding stent 2 is specifically a duodenal papilla expanding stent, wherein the duodenal papilla expanding stent is used to provide a placement channel for the drainage catheter.

[0036] It should be noted that the expansion stent 2 adopts a duodenal papilla expansion stent, which has the following functions: 1. providing a space for cholangioscopy operation; 2. avoiding sphincterotomy and protecting sphincter function; 3. providing a stable insertion channel for drainage catheters. The duodenal papilla expansion stent expands the duodenal papilla area to ensure that the drainage catheter can smoothly enter the gallbladder and maintain good channel patency. This stent design can reduce the risk of bile duct obstruction during treatment, ensure accurate positioning and stability of the drainage catheter, and thus improve the treatment effect and safety of the entire gallbladder stone removal system.

[0037] In one possible implementation, the first drainage port 101 is provided with a first drainage port connector 1011 for connecting a drainage bag.

[0038] It should be noted that the first drainage port 101 is provided with a first drainage port connector 1011 for connecting a drainage bag, which is designed to connect the drainage catheter with the drainage bag. The drainage bag is used to collect the liquid or debris discharged from the gallbladder, ensuring that the liquid in the gallbladder can be effectively drained during treatment, avoiding liquid accumulation leading to discomfort or complications. This design makes the drainage process of the system more efficient and convenient, while improving the safety of treatment and the comfort of patients.

[0039] In one possible implementation, the buckle 102 is a claspable buckle.

[0040] It can be understood that the buckle 102 is designed as a claspable buckle, which can stably fix the position of the drainage catheter, ensuring that the device does not shift or loosen during treatment, thereby improving the stability and safety of treatment.

[0041] In one possible implementation, the wire connector 104 is specifically an SMA male connector. The SMA male connector is used to connect with a power amplifier or a host computer.

[0042] It should be noted that the wire connector 104 adopts an SMA male connector design, which is a connector commonly used for high-frequency signal transmission and has good stability and durability. It is used to connect the wire with a power amplifier or a host computer to ensure that the system can stably transmit energy or signals to drive the transducer to work normally. This design enables the entire gallbladder stone removal system to be seamlessly connected with external equipment, ensuring stable and accurate energy input during treatment, and improving the effectiveness and safety of treatment.

[0043] In one possible implementation, each of the transducers 3 is specifically a 1MHz frequency strip-shaped piezoelectric ceramic ultrasonic transducer.

[0044] It should be noted that the transducer 3 is specifically a 1 MHz frequency strip-shaped piezoelectric ceramic ultrasonic transducer. The piezoelectric ceramic material can produce mechanical vibration under the action of an electric field, thereby converting electrical energy into ultrasonic wave energy. The frequency of 1 MHz is suitable for the crushing and removal of gallbladder stones. Through the action of high-frequency ultrasonic waves, the stones can be effectively crushed and promoted to be discharged out of the body. The strip-shaped design makes the transducer better adapt to the space of the gallbladder, accurately act on the stone area, improve the removal effect, and reduce the damage to the surrounding tissues.

[0045] Specifically, the principle of ultrasonic lithotripsy is cavitation. The cavitation threshold increases with the increase of frequency. Low frequency (especially <1 MHz) is more likely to induce cavitation. High-frequency ultrasound requires higher energy to trigger cavitation, but high energy will increase the risk of tissue thermal damage. The current ultrasonic ablation catheter uses a high-frequency ultrasonic transducer. In vitro ultrasonic lithotripsy of gallbladder stones was popular in the 1980s. Unlike ultrasonic lithotripsy of kidney stones, it is difficult to remove the crushed gallbladder stones from the gallbladder duct. The embedded stone fragments in the gallbladder duct or common bile duct can induce cholecystitis, cholangitis, and even biliary pancreatitis. In addition, the efficiency of in vitro ultrasonic lithotripsy is low, and an ultrasonic transducer capable of entering the gallbladder is needed for lithotripsy.

[0046] The size of the ultrasonic transducer is usually related to the wavelength of its working frequency. Low-frequency ultrasonic transducers need larger sizes to accommodate the vibration elements due to their longer wavelengths. Therefore, if cavitation is to be used for lithotripsy and the catheter can pass through the gallbladder duct, the size of the transducer must be 2 mm. It is necessary to achieve the lowest frequency (<1 MHz) at this size to reduce thermal damage and enhance cavitation.

[0047] More specifically, the transducer is designed as a low-frequency (1 MHz) strip-shaped piezoelectric ceramic structure. Unlike the commonly used frequency (20 kHz) of in vitro ultrasonic lithotripsy and the high-frequency ultrasound (>9 MHz) commonly used in ultrasonic ablation catheters, the 1 MHz miniature ultrasonic transducer used in the present invention is mainly based on the following considerations: First, the degree of stone crushing is related to the frequency. Compared with 20 kHz ultrasonic waves, 1 M ultrasonic waves are more likely to become fine powders when acting on stones, which can be drained out of the drainage tube. Second, safety and effectiveness must be considered when applying ultrasound to the human body. Literature shows that 1 MHz, 2 W / cm 2 The size of the ultrasonic transducer is usually related to the wavelength of its working frequency. Low-frequency ultrasonic transducers need larger sizes to accommodate the vibration elements due to their longer wavelengths. Compared with 1 M ultrasonic waves, the wavelength is shorter, and its size can be reduced to 2 mm. Therefore, only the ultrasonic transducer with a frequency of 1 M and a strip-shaped structure can meet the requirements of 2 mm thickness and low frequency, allowing the miniature ultrasonic probe to smoothly pass through the duodenoscope channel (3.2 mm) and the gallbladder duct (3 mm).

[0048] In a possible implementation, the maximum size of the strip-shaped piezoelectric ceramic ultrasonic transducer is 2mm.

[0049] It should be noted that based on the working frequency of the transducer and its structure, the maximum size of the strip-shaped piezoelectric ceramic ultrasonic transducer is 2mm, which is designed to ensure that the transducer can accurately adapt to the limited space inside the gallbladder, while providing sufficient ultrasonic energy to effectively break the stones and reduce damage to the surrounding tissues.

[0050] In a possible implementation, it further comprises a power supply 4.

[0051] Each of the transducers 3 is connected in parallel with the power supply 4.

[0052] It should be noted that the power supply 4 provides the required power for the system, ensuring that each transducer 3 can work normally. Each transducer is connected in parallel with the power supply 4, so that each transducer 3 can independently obtain stable power supply, ensuring uniform transmission of ultrasonic energy, improving the overall efficiency and treatment effect of the system.

[0053] In a possible implementation, it further comprises a temperature sensor 5.

[0054] The temperature sensor 5 is connected in parallel with the power supply 4.

[0055] It can be understood that the temperature sensor 5 is connected in parallel with the power supply 4, which is used to monitor the temperature changes of the device or the gallbladder area in real time during the treatment process. The temperature sensor can ensure that the system operates within a safe temperature range, avoiding tissue damage or other adverse reactions caused by excessive temperature. By being connected in parallel with the power supply, the sensor can feedback temperature information in time to adjust the power supply to ensure the safety of the treatment process. It can be set to automatically stop power supply when the temperature is greater than 42℃.

[0056] Specifically, the cross-sectional area of the lumen of the drainage cavity 108 is greater than that of the wire cavity 109.

[0057] It should be noted that the cross-sectional area of the lumen of the drainage cavity 108 is greater than that of the wire cavity 109, which is designed to ensure that the liquid in the gallbladder can flow smoothly and accelerate the discharge of stones. The larger cross-sectional area of the drainage cavity helps to improve the drainage efficiency, while the smaller wire cavity helps to stabilize the transmission of electric energy or signal, ensuring the normal work of the transducer. The design of the two complements each other, improving the overall treatment effect.

[0058] In practical applications, the entire gallbladder stone removal system optimizes the stone removal process through the coordinated action of the drainage catheter, the expansion stent, and multiple transducers. The multiple drainage holes of the drainage catheter and the device-side holes promote liquid flow and precise positioning of the transducers, effectively removing stones from the gallbladder. The expansion stent provides a scope operating space, protects the duodenal papillary sphincter function, and provides a channel for gallbladder stone debris to flow out. The transducers shatter stones through ultrasonic energy and provide stable energy through a parallel-connected power supply. The temperature sensor monitors and adjusts the system temperature in real time to avoid overheating damage. This system can improve stone removal efficiency, reduce gallbladder damage and surgical risk, and solve the problems of stone recurrence and incomplete removal in traditional treatment methods. More specifically, the gallbladder stone removal system uses a 1MHz low-frequency strip-shaped piezoelectric ceramic transducer, with a size reduced to 2mm. This design solves the problem of miniaturization of low-frequency ultrasonic devices, enabling the device to pass through the endoscopic channel (3.2mm) and the gallbladder duct (3mm). This is a core hardware innovation. In terms of drug systems, a d-limonene mixed preparation (with a surfactant added) is used to form an oil-in-water emulsion. This improves the dispersibility of the stone dissolving agent in bile, while reducing the cavitation threshold and enhancing the efficiency of ultrasonic lithotripsy. This is an innovation in drug formulation. In terms of system integration, the ultrasonic lithotripsy, drug stone dissolution, and stent protection modules are integrated into a coordinated system. The duodenal papilla support prevents stone blockage, and the negative pressure suction removes debris in real time.

[0059] The above merely provides a specific implementation of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of changes or replacements within the technical scope disclosed by the present application, which shall be covered within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

[0060] The following points need to be explained: (1) The drawings of the embodiments of the present application only involve the structures involved in the embodiments of the present application, and other structures can refer to the usual design.

[0061] (2) For the sake of clarity, the thickness of a layer or region is exaggerated or reduced in the drawings used to describe the embodiments of the present application, i.e., these drawings are not drawn according to the actual proportions. It can be understood that when an element such as a layer, film, region or substrate is referred to as being "on" or "under" another element, it can be "directly" on or under the other element or there can be an intermediate element.

[0062] (3) In the case of no conflict, the embodiments of the present application and the features in the embodiments can be combined with each other to obtain new embodiments.

[0063] The above merely illustrates the specific embodiments of the present application, but the protection scope of the present application is not limited thereto, and the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A gallbladder stone removal system, characterized in that, include: Drainage catheter, dilation stent, and multiple transducers; The drainage catheter extends through the dilation stent; The drainage catheter is provided with a first drainage port, a buckle, a tee port, a wire connector, and a second drainage port in sequence in the first direction; Multiple device side holes for embedding each of the transducers and multiple drainage holes for accelerating drainage are provided on the side wall of the drainage conduit at one end of the second drainage port. The drainage catheter has parallel drainage cavities and wire cavities inside; The device side hole is connected to the wire cavity, and the drainage hole is connected to the drainage cavity.

2. The gallbladder stone removal system according to claim 1, characterized in that, The dilatation stent is specifically a duodenal papilla dilatation stent, wherein the duodenal papilla dilatation stent is used to provide an insertion channel for the drainage catheter.

3. The gallbladder stone removal system according to claim 1, characterized in that, The first drainage port is provided with a first drainage port connector for receiving the drainage bag.

4. The gallbladder stone removal system according to claim 1, characterized in that, The buckle is a clampable buckle.

5. The gallbladder stone removal system according to claim 1, characterized in that, The wire connector is specifically an SMA male connector; The SMA male connector is used to connect to a power amplifier or host computer.

6. The gallbladder stone removal system according to claim 1, characterized in that, Each of the transducers is specifically a strip-shaped piezoelectric ceramic ultrasonic transducer with a frequency of 1MHz.

7. The gallbladder stone removal system according to claim 6, characterized in that, The maximum size of the strip-shaped piezoelectric ceramic ultrasonic transducer is 2 mm.

8. The gallbladder stone removal system according to claim 1, characterized in that, Also includes: Power supply; Each of the transducers is connected in parallel with the power supply.

9. The gallbladder stone removal system according to claim 8, characterized in that, Also includes: Temperature sensor; The temperature sensor is connected in parallel with the power supply.

10. The gallbladder stone removal system according to claim 1, characterized in that, The litholytic drug of the gallbladder stone removal system is a d-limonene mixture prepared from 97% d-limonene, 2.1% polysorbate-80 and 0.9% sorbitol monooleate.

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