In-vivo calculus crushing device, system and treatment method

Abstract

The invention relates to the technical field of medical devices, in particular to an in-vivo calculus crushing device, system and treatment method.The in-vivo calculus crushing device comprises a gel supply device used for providing multiple biological affinity gels with different viscosities; the gel injection device is connected with the gel supply device through a catheter and used for injecting the gel with the target viscosity into the area where the calculus is located in the body of the patient; the stone crushing equipment is used for performing crushing operation on stones in a gel filling environment; the gel suction device is used for sucking out the crushed stone fragments and gel; and the processing unit is used for acquiring the attribute parameters of the target stone and the energy parameters of the stone crushing equipment, and calculating the target viscosity of the gel and / or the gel filling safety distance according to the attribute parameters of the target stone and the energy parameters of the stone crushing equipment. Therefore, the problems that in the prior art, when the calculus is too hard or too large in size, the broken stone is prone to splashing, calculus taking is difficult, the operation time is prolonged, and the safety risk of a patient is increased are solved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an in vivo stone breaking device, system and processing method. Background Technology

[0002] In clinical medicine, the treatment of internal stones (such as kidney stones, gallstones, and ureteral stones) has always been an important topic in urology and hepatobiliary surgery. For stones that are too large or located in unusual positions, they cannot be expelled naturally or dissolved by medication and must be treated surgically or with minimally invasive interventional techniques. Currently, the following three methods are mainly used clinically for stone removal surgery: The first manual lithotripsy method involves inserting a specially designed thin steel wire loop through an endoscope to the location of the stone. Mechanical force is used to break the stone into smaller fragments, which are then removed one by one using a catheter or stone retrieval basket. This method is simple to operate and requires minimal equipment, but it is labor-intensive, inefficient, and demands a high level of physical strength and skill from the operator. Currently, this method is mainly used in remote areas with limited medical resources and is rarely used in modern hospitals.

[0003] The second method, extracorporeal or intracorporeal shock wave lithotripsy, utilizes high-voltage discharge to generate shock waves in a liquid, focusing energy to shatter the stones. Its advantage lies in its effectiveness against various types of stones, and the minimal damage to human tissue caused by the shock wave energy. However, this method has significant drawbacks: for larger stones, the shock wave can cause stone fragments to scatter at high speeds, especially in areas with narrow anatomical structures such as the bile ducts, renal calyces, and ureters. These flying fragments can easily damage the mucous membranes, leading to complications such as bleeding and perforation. Furthermore, the scattering effect of the shock wave can also cause unnecessary damage to surrounding healthy tissues.

[0004] The third method is holmium laser lithotripsy: A high-energy laser beam is delivered directly to the stone surface via optical fiber, achieving precise and delicate stone fragmentation. Its advantages lie in the high controllability of the fragmentation process and minimal thermal damage to surrounding tissues. However, this method also has significant drawbacks: for large or impacted stones, the procedure often lasts several hours, increasing patient discomfort (usually requiring non-general anesthesia) and potentially leading to stone displacement or laser damage to surrounding tissues. Furthermore, postoperative flushing with copious amounts of saline solution is still necessary to remove the fragments, which may cause osmotic pressure damage to the kidneys, increasing the patient's burden.

[0005] In related techniques, when dealing with impacted stones, the stones are tightly adhered to the tube wall, making them prone to displacement or fragmentation during lithotripsy, significantly increasing surgical risks. Furthermore, traditional methods rely on large amounts of saline flushing, which not only prolongs the procedure but may also disrupt the patient's physiological environment. Summary of the Invention

[0006] This application provides an internal stone fragmentation device, system, and processing method to solve the problems in related technologies, such as the easy splashing of fragments when the stones are too hard or too large, leading to difficulties in stone removal, prolonged operation time, and increased patient safety risks.

[0007] The first aspect of this application provides an in vivo stone fragmentation device, comprising: a gel supply device for providing various biocompatible gels of different viscosities; a gel injection device connected to the gel supply device via a catheter for injecting a gel of a target viscosity into the area of ​​the stone in the patient's body; a lithotripsy device for fragmenting the stone in a gel-filled environment; a gel suction device for suctioning out the fragmented stone fragments and the gel; and a processing unit communicatively connected to the gel supply device, the gel injection device, the gel suction device, and the lithotripsy device for acquiring property parameters of the target stone and energy parameters of the lithotripsy device, and calculating the target viscosity of the gel and / or the safe gel filling distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device.

[0008] Optionally, the gel supply device includes: at least one container containing different base gel raw materials and at least one drive component, wherein the drive component is used to mix at least one base gel raw material in the container to prepare a gel of a target viscosity.

[0009] Optionally, the gel supply device further includes a staining agent adding module for adding different biological staining agents to gels of different viscosities to generate visual distinctions.

[0010] Optionally, the gel injection device further includes a dual-lumen catheter with visual markings, wherein the first lumen of the dual-lumen catheter is used to inject a gel with a viscosity greater than or equal to a preset viscosity, and the second lumen is used to inject a gel with a viscosity less than the preset viscosity.

[0011] Optionally, when the lithotripsy device is a holmium laser, the gel supply device is configured to provide an emulsified gel containing scattering particles.

[0012] A second aspect of this application provides an in vivo stone fragmentation system, comprising: an in vivo stone fragmentation device; and a controller electrically connected to the in vivo stone fragmentation device for controlling the gel supply device to dispense a gel of a target viscosity, and controlling the gel injection device to inject the gel of the target viscosity into the area of ​​the stone in the patient's body according to a gel filling safety distance.

[0013] A third aspect of this application provides a method for processing an in vivo stone fragmentation system. The method is applied to the in vivo stone fragmentation system and includes the following steps: obtaining the property parameters of the target stone and the energy parameters of the lithotripsy device; calculating the target viscosity of the gel and the safe gel filling distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device; and controlling the in vivo stone fragmentation system to perform corresponding operations based on the target viscosity of the gel and the safe gel filling distance.

[0014] Optionally, calculating the target viscosity of the gel based on the attribute parameters of the target stone and the energy parameters of the lithotripsy device includes: obtaining a first mapping table, wherein the first mapping table is a mapping relationship between the attribute parameters of the target stone, the energy parameters of the lithotripsy device, and the target viscosity of the gel; and querying the first mapping table using the attribute parameters of the target stone and the energy parameters of the lithotripsy device as indexes to determine the target viscosity of the gel.

[0015] Optionally, calculating the gel filling safety distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device includes: ; in, For electrode kinetic energy, Let be the approximate radius of the fragment. The dynamic viscosity coefficient, Let m be the energy dissipation angle, and m be the mass of the stone in the patient's body. The radius of the cavity at the site of the stone.

[0016] Optionally, controlling the in vivo stone fragmentation system to perform corresponding operations based on the target viscosity of the gel and the gel filling safety distance includes: configuring a biocompatible gel with a corresponding viscosity value based on the target viscosity of the gel; injecting the gel with the target viscosity into the anterior and posterior regions of the stone in stages through a dual-lumen catheter, wherein the gel filling thickness injected into the posterior region of the stone is greater than or equal to the gel filling safety distance.

[0017] Therefore, this application has at least the following beneficial effects: (1) The embodiments of this application can use the processing unit to obtain the attribute parameters (such as size, hardness, and location) of the target stone and the energy parameters of the lithotripsy device in real time, intelligently calculate and determine the optimal viscosity of the required gel and the safe distance for gel filling, and control the gel supply device and injection device to accurately inject the biocompatible gel of a specific viscosity into the stone area. In the high viscosity environment of the gel, when the lithotripsy device performs the crushing operation, the gel effectively absorbs the impact energy, inhibits the splashing of stone fragments, and reduces the risk of damage to surrounding tissues. The crushed stone fragments are wrapped in the gel and suspended in it, which makes it easy for the gel suction device to efficiently suck out the stone fragments and gel together. This achieves precision, safety and efficiency in the lithotripsy process, significantly shortens the operation time, reduces the amount of irrigation fluid used, avoids complications such as osmotic pressure imbalance, and improves the overall safety and minimally invasiveness of the treatment.

[0018] (2) The embodiments of this application can systematically obtain the attribute parameters of the target stone and the energy parameters of the lithotripsy device, accurately calculate the optimal gel target viscosity and gel filling safety distance based on these data, and intelligently control the in vivo stone fragmentation system to perform gel preparation, step-by-step injection and lithotripsy operation, realizing the precision and automation of the whole process from preoperative assessment to intraoperative execution, ensuring that the gel viscosity and filling range are matched with the patient's individual anatomical characteristics and lithotripsy energy, effectively inhibiting the splashing of stone fragments, protecting surrounding tissues, and significantly improving the safety, efficiency and repeatability of the operation.

[0019] Additional aspects and advantages of this application will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of this application. Attached Figure Description

[0020] The above and / or additional aspects and advantages of this application will become apparent and readily understood from the following description of the embodiments taken in conjunction with the accompanying drawings, wherein: Figure 1 This is a block diagram of an in vivo stone breaking device according to an embodiment of this application; Figure 2 This is a block diagram of an in vivo stone fragmentation system provided according to an embodiment of this application; Figure 3 This is a schematic flowchart of the in-body stone fragmentation system processing method provided according to an embodiment of this application; Figure 4 This is a schematic diagram of a gel post-injection according to an embodiment of this application; Figure 5 This is a schematic diagram of pre-gel injection according to an embodiment of this application; Figure 6 This is a schematic diagram of a stone crushing operation according to an embodiment of this application; Figure 7 This is a schematic diagram of gravel attraction according to one embodiment of this application; Figure 8 This is a schematic diagram of posterior gel injection for stones according to another embodiment of this application; Figure 9 This is a schematic diagram of anterior gel injection for stones according to another embodiment of this application; Figure 10 This is a schematic diagram of laser lithotripsy operation according to another embodiment of this application; Figure 11 This is a schematic diagram of gel attraction according to another embodiment of this application; Figure 12 This is a schematic diagram illustrating the scattering principle when a laser is accidentally injected into the gel after the stone is formed, according to another embodiment of this application. Detailed Implementation

[0021] The embodiments of this application are described in detail below. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this application, and should not be construed as limiting this application.

[0022] Currently, there are three methods for treating kidney stones in surgery to remove excessively large stones that cannot be expelled on their own. The first is manual lithotripsy, where a thin steel wire is placed around the stone through a catheter, and a lot of effort is required to manually break the stone into smaller pieces, which are then removed using a catheter claw. The second is high-voltage discharge, which creates a shock wave to shatter the stone before removal. The third is holmium laser treatment. The first method is mostly used in remote, underdeveloped mountainous areas with few patients, while the second method was invented in the Soviet Union in the last century and is still in use today. Its advantages are that it is effective for any type of stone, can directly shatter the stone, and the high-voltage discharge has high power but low energy, resulting in minimal damage to the body. However, its disadvantages are also obvious. For large stones, although it can directly shatter them, there is a probability of stone fragmentation. Some fragments may fly out at high speed and easily cause skin damage and bleeding in narrow locations such as the gallbladder, kidney, especially the bile duct, renal calyces, and ureter. The third method, introduced in the last decade or so, offers the advantage of fine stone fragmentation, but its disadvantages are equally apparent. A single holmium laser stone-breaking surgery can easily take several hours (generally, these surgeries are performed on large or multiple stones; smaller stones are usually expelled through a combination of medication and spontaneous expulsion). Furthermore, it is not performed under general anesthesia, which can cause significant psychological stress for the patient, as well as the physical discomfort of prolonged immobility. There are also instances where holmium laser surgery has been used to accidentally damage the stone site.

[0023] Especially when the stones are too hard or too large, resulting in stone impaction, it poses a significant challenge in clinical stone surgery. During endoscopic procedures such as ERCP (Endoscopic Retrograde Cholangiopancreatography), stone impaction can occur when the stones are too hard or too large—a highly undesirable emergency that prolongs surgery time and increases patient risk. Endoscopic lithotripsy baskets, used for routine lithotripsy, are difficult to manage when stones are impacted. Even with devices to increase mechanical force, the problem remains, and the risk of uncontrollable surgical complications increases significantly. Force transmission within the tubing deteriorates considerably after a certain point, ultimately requiring surgical stone removal.

[0024] To address the shortcomings of the second and third methods mentioned above, a device has been developed that involves perfusion with a biocompatible gel before surgery, completely avoiding the drawbacks of these methods. Furthermore, by adjusting the gel ratio and combining it with an intelligent stone fragmentation system, the device demonstrates superior effectiveness in handling easily lodged stones, offering greater applicability. The fragmented stones are also more easily and quickly expelled along with the gel, significantly reducing stone retrieval time. This also reduces the osmotic pressure damage to the patient's kidneys caused by excessive saline flushing, resulting in better medical outcomes.

[0025] The following description, with reference to the accompanying drawings, describes an embodiment of an in-body stone breaking device, system, and processing method of this application.

[0026] Specifically, Figure 1 This is a block diagram of an in vivo stone-breaking device according to an embodiment of this application.

[0027] like Figure 1 As shown, the internal stone breaking device 10 includes: a gel supply device 110, a gel injection device 120, a stone breaking device 130, a gel suction device 140, and a processing unit 150.

[0028] The system includes a gel supply device 110 for providing biocompatible gels of various viscosities; a gel injection device 120 connected to the gel supply device 110 via a catheter for injecting gel of the target viscosity into the area of ​​the stone in the patient's body; a lithotripsy device 130 for breaking up the stone in a gel-filled environment; a gel suction device 140 for suctioning out the broken stone fragments and gel; and a processing unit 150 communicatively connected to the gel supply device 110, gel injection device 120, gel suction device 130, and lithotripsy device 140 for acquiring the property parameters of the target stone and the energy parameters of the lithotripsy device, and calculating the target viscosity of the gel and / or the safe gel filling distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device.

[0029] It is understood that the embodiments of this application can utilize the processing unit to obtain the attribute parameters (such as size, hardness, and location) of the target stone and the energy parameters of the lithotripsy device in real time, intelligently calculate and determine the optimal viscosity of the required gel and the safe distance for gel filling, and control the gel supply device and injection device to accurately inject the biocompatible gel of a specific viscosity into the stone area. In the high viscosity environment of the gel, when the lithotripsy device performs the crushing operation, the gel effectively absorbs the impact energy, inhibits the splashing of stone fragments, and reduces the risk of damage to surrounding tissues. The crushed stone fragments are encapsulated and suspended in the gel, making it easy for the gel suction device to efficiently extract the stone fragments and gel together. This achieves precision, safety, and efficiency in the lithotripsy process, significantly shortens the operation time, reduces the amount of irrigation fluid used, avoids complications such as osmotic pressure imbalance, and improves the overall safety and minimally invasiveness of the treatment.

[0030] It should be noted that the gel used is a type of gel that is harmless to the human body, such as sodium carboxymethyl cellulose or hyaluronic acid. Pure protein-based whey protein, like the protein in raw eggs, can also be used; if modified to increase its cohesiveness, it will be even better. The lithotripsy equipment includes a lithotripsy electrode, which is connected to an in vivo impact lithotripter to generate electrical pulses to break up the stones.

[0031] In this embodiment of the application, the gel supply device 110 includes: at least one container containing different base gel raw materials and at least one driving component.

[0032] The driving component is used to mix at least one base gel raw material in the container to prepare a gel with a target viscosity.

[0033] It is understood that, by setting multiple containers for holding different basic gel raw materials and corresponding driving components in the gel supply device, the driving components can precisely control the proportion and mixing process of each basic gel raw material according to the instructions of the processing unit, and dynamically adjust the bio-affinity gel with the target viscosity on site. This achieves on-demand customization of gel viscosity, improves the system's adaptability and response accuracy to different types of stones and lithotripsy energy, and ensures that the optimal viscosity gel environment can be provided in different clinical scenarios. This effectively buffers the impact of lithotripsy, inhibits fragment splashing, and facilitates the integrated removal of lithotripsy and gel, thereby improving the safety and intelligence level of treatment.

[0034] In this embodiment, the gel supply device 110 further includes a dye addition module.

[0035] The staining agent addition module is used to add different biological staining agents to gels of different viscosities to generate visual distinctions.

[0036] It is understood that the gel supply device in this application embodiment is equipped with a dye addition module, which can add specific biocompatible dyes to gels of different viscosities, so that gels of different viscosities can be visually distinguished by color or optical characteristics. This makes it easier for medical staff to identify the type and viscosity of the injected gel in real time during the operation, effectively preventing misuse or confusion and improving the safety and accuracy of the operation. At the same time, the dyed gel helps to clearly define the surgical area, observe the distribution range and filling effect of the gel, and assist in judging the establishment of the lithotripsy environment, further enhancing the visualization and controllability of the operation, and providing strong support for precise and safe lithotripsy and stone removal operations.

[0037] It should be noted that the staining agent is used to stain gels with different ratios or components so that they can be distinguished during surgery.

[0038] In this embodiment of the application, the gel injection device 120 further includes a dual-lumen catheter with visual markings.

[0039] The first lumen of the dual-lumen catheter is used to inject gel with a viscosity greater than or equal to a preset value, and the second lumen is used to inject gel with a viscosity less than the preset value.

[0040] The preset viscosity can be set according to actual needs without specific limitations.

[0041] It is understood that the embodiments of this application can achieve independent delivery and precise control of gels of different viscosities by using a dual-lumen catheter with visual markings in the gel injection device: the first lumen is used to deliver high-viscosity gels with a viscosity greater than or equal to a preset value, providing the buffering and fixation required for the lithotripsy process; the second lumen is used to deliver low-viscosity gels, facilitating initial filling or adjustment of the local rheological environment; the dual-lumen structure avoids mutual interference and mixing of gels of different viscosities during delivery, ensuring stable rheological properties; at the same time, the visual markings on the catheter facilitate medical staff to quickly identify the function of the lumens and the type of gel, improving the intuitiveness and safety of the operation, realizing the synergistic delivery of multifunctional gels, enhancing the adaptability to complex stone environments, and optimizing the gel distribution and functional regulation before and after lithotripsy.

[0042] In this embodiment of the application, when the lithotripsy device is a holmium laser, the gel supplied by the gel supply device is an emulsified gel containing scattering particles.

[0043] It is understood that, in the embodiments of this application, when the lithotripsy device is a holmium laser, the emulsified gel containing scattering particles provided by the gel supply device can effectively disperse the beam energy under the action of the laser, reducing the risk of thermal damage to the tissue behind the stone. At the same time, the scattering particles enhance the gel's ability to absorb laser energy and diffuse heat, slow down the local temperature rise, and maintain the stability of the gel's rheological properties. This not only provides mechanical buffering to suppress the splashing of stone fragments, but also improves the safety and controllability of holmium laser lithotripsy through its optical controllability, effectively protecting the surrounding sensitive tissues and achieving more precise and gentle lithotripsy treatment.

[0044] The in vivo stone fragmentation device proposed in this application utilizes a processing unit to acquire the target stone's attribute parameters (such as size, hardness, and location) and the energy parameters of the lithotripsy equipment in real time. It intelligently calculates and determines the optimal viscosity of the required gel and the safe gel filling distance. The gel supply and injection devices are then controlled to precisely inject a biocompatible gel of a specific viscosity into the stone area. In the high-viscosity environment of the gel, during the fragmentation operation, the gel effectively absorbs impact energy, suppresses stone fragment splashing, and reduces the risk of damage to surrounding tissues. The fragmented stone fragments are encapsulated and suspended within the gel, facilitating efficient extraction of the fragments and gel together by the gel suction device. This achieves precision, safety, and efficiency in the lithotripsy process, significantly shortening the operation time, reducing the amount of irrigation fluid used, avoiding complications such as osmotic pressure imbalance, and improving the overall safety and minimally invasive nature of the treatment.

[0045] Figure 2 This is a block diagram of the in vivo stone breaking system according to an embodiment of this application.

[0046] like Figure 2 As shown, the internal stone breaking system 20 includes: an internal stone breaking device 10 and a controller 210.

[0047] The controller 210 is electrically connected to the internal stone fragmentation device 20 and is used to control the gel supply device to dispense gel of the target viscosity and to control the gel injection device to inject gel of the target viscosity into the area of ​​the stone in the patient's body according to the gel filling safety distance.

[0048] According to the internal stone fragmentation system proposed in this application, the controller is electrically connected to the internal stone fragmentation device, enabling it to acquire real-time parameter information of the stone fragmentation operation. Based on preset algorithms or instructions from the processing unit, it precisely controls the gel supply device to prepare gel with the required target viscosity. Simultaneously, based on the calculated safe gel filling distance, it coordinates and controls the gel injection device to quantitatively and precisely inject the gel into the area where the stone is located. This achieves automation and intelligence in the gel preparation and injection process, ensuring that the rheological properties and filling range of the gel are highly matched with the current stone fragmentation requirements. It effectively plays its role in buffering and protecting, fixing the stone, and suppressing fragment splashing, significantly improving the safety, accuracy, and overall efficiency of the surgery.

[0049] Figure 3 This is a schematic flowchart illustrating a method for processing an in vivo stone fragmentation system provided in an embodiment of this application.

[0050] like Figure 3 As shown, the treatment method of the in vivo stone fragmentation system, applied to the in vivo stone fragmentation system, includes the following steps: In step S101, the property parameters of the target stone and the energy parameters of the lithotripsy device are obtained.

[0051] The target stone's properties include size, density, hardness, location, and degree of embedding, while the lithotripsy equipment's energy parameters include shock wave energy, laser power, and pulse frequency.

[0052] It is understood that the embodiments of this application can obtain the property parameters of the target stone and the energy parameters of the lithotripsy equipment, so as to fully understand the physical environment and energy input conditions faced by the lithotripsy operation, and provide a key data foundation for subsequent accurate calculation of the target viscosity of the gel and the filling safety distance.

[0053] In step S102, the target viscosity of the gel and the safe distance for gel filling are calculated based on the property parameters of the target stone and the energy parameters of the lithotripsy equipment.

[0054] It is understood that, according to the property parameters of the target stone (such as size, density, hardness) and the energy parameters of the lithotripsy equipment (such as impact energy or laser power), the target viscosity and filling safety distance of the gel can be calculated by physical models or algorithms. This enables precise control of the lithotripsy environment, ensuring that the selected gel has sufficient viscous resistance to effectively suppress the splashing kinetic energy of the stone fragments. At the same time, the necessary filling length of the gel behind the stone is determined to fully absorb and dissipate the impact energy generated during lithotripsy, thereby maximizing the protection of surrounding sensitive tissues from damage.

[0055] In this embodiment of the application, the target viscosity of the gel is calculated based on the attribute parameters of the target stone and the energy parameters of the lithotripsy device, including: obtaining a first mapping table, wherein the first mapping table is a mapping relationship between the attribute parameters of the target stone, the energy parameters of the lithotripsy device and the target viscosity of the gel; and querying the first mapping table using the attribute parameters of the target stone and the energy parameters of the lithotripsy device as indexes to determine the target viscosity of the gel.

[0056] It is understood that, through the pre-establishment and acquisition of a first mapping table containing the correspondence between target stone attribute parameters (such as size, density, and hardness) and lithotripsy equipment energy parameters (such as power and frequency) and the target viscosity of the gel, the system can quickly and accurately query and determine the optimal viscosity of the required gel using the actually measured stone and equipment parameters as indexes. This transforms the complex physical calculation model into an efficient data lookup process, significantly improving the response speed and clinical applicability of gel configuration. While ensuring the precision of personalized treatment, it simplifies the operation process, realizes the intelligent and standardized matching of the viscosity of the gel used for lithotripsy protection, and enhances the safety and repeatability of the surgery.

[0057] It should be noted that the first mapping table is a gel preparation table, used to configure the gel viscosity. The table should be entered at an internal human temperature of 36-38 degrees Celsius. Different viscosities are measured after preparing the gel using the same volume of physiological saline and increasing amounts of gel raw materials. A falling ball viscosity test is used here, primarily to measure impact resistance, to prevent damage to the endothelium from stone fragments during impact lithotripsy. Another aspect is suspension performance. The data in this table requires suspension tests on multiple stones removed from patients (different types of stones have different densities; for example, gallstones can be classified as cholesterol stones, pigment stones, and mixed stones). Experiments show that a gel is not necessarily better the thicker it is. Different viscosities are used for different scenarios, facilitating gel injection, surgery, and removal. An overly viscous gel requires greater pressure during injection, which can be excessive when filling bile ducts, renal calyces, or ureters. Conversely, a gel that is too viscous will not suspend the stones or distend the bile duct.

[0058] In this embodiment of the application, the calculation of the gel filling safety distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device includes: ; in, For electrode kinetic energy, Let be the approximate radius of the fragment. The dynamic viscosity coefficient is... Let m be the energy dissipation angle, and m be the mass of the stone in the patient's body. The radius of the cavity at the site of the stone.

[0059] It is understood that the embodiments of this application can comprehensively consider factors such as lithotripsy kinetic energy, fluid resistance and anatomical structure, and accurately calculate the minimum gel filling length required to effectively prevent fragments from splashing forward and protect distal tissues, thereby realizing the individualized and precise setting of the gel protection range, significantly improving surgical safety and avoiding the risks and waste of resources caused by insufficient or excessive filling.

[0060] In step S103, the in vivo stone fragmentation system is controlled to perform corresponding operations based on the target viscosity of the gel and the safe distance for gel filling.

[0061] It is understood that the embodiments of this application can control the in vivo stone fragmentation system to perform corresponding operations based on the target viscosity of the gel and the safe distance of gel filling, ensuring that the physical parameters (viscosity and filling length) of the stone fragmentation environment match the current characteristics of the stone and the stone fragmentation energy, so that the gel can give full play to its role in buffering energy absorption, fixing the stone and inhibiting fragment splashing, thereby establishing an optimal safety protection barrier before the stone fragmentation equipment is started, significantly improving the accuracy, safety and automation level of the in vivo stone fragmentation process, effectively reducing the risk of tissue damage and optimizing the overall treatment effect.

[0062] In this embodiment, the in vivo stone fragmentation system is controlled to perform corresponding operations based on the target viscosity of the gel and the safe distance for gel filling, including: configuring a biocompatible gel with a corresponding viscosity value according to the target viscosity of the gel; injecting the gel with the target viscosity into the anterior and posterior regions of the stone in stages through a dual-lumen catheter, wherein the gel filling thickness injected into the posterior region of the stone is greater than or equal to the safe distance for gel filling.

[0063] It is understood that, according to the calculated target viscosity of the gel and the safe filling distance, the system can precisely configure biocompatible gels of appropriate viscosity and use a dual-lumen catheter to inject gels with different functions into the stone area in stages. High-viscosity gels are injected first into the rear to ensure that their filling thickness is not less than the calculated safe distance, so as to effectively absorb the impact energy of lithotripsy and prevent fragments from splashing backward. Low-viscosity gels are injected into the front to facilitate the operation of lithotripsy equipment and reduce disturbance. This collaborative control strategy realizes the dual optimization of the spatial distribution and functional characteristics of the gel, which not only establishes a safety barrier that meets mechanical requirements, but also ensures the flexibility of surgical operation, significantly improving the safety, accuracy and overall efficiency of the lithotripsy process.

[0064] According to the processing method of the in vivo stone fragmentation system proposed in the embodiments of this application, the property parameters of the target stone and the energy parameters of the lithotripsy device are systematically obtained. Based on these data, the optimal target gel viscosity and the safe distance for gel filling are accurately calculated. Based on this, the in vivo stone fragmentation system is intelligently controlled to perform gel preparation, step-by-step injection and lithotripsy operation. This achieves precision and automation of the entire process from preoperative assessment to intraoperative execution, ensuring that the gel viscosity and filling range are matched with the patient's individual anatomical characteristics and lithotripsy energy. This effectively inhibits the splashing of stone fragments, protects surrounding tissues, and significantly improves the safety, efficiency and repeatability of the operation.

[0065] The following will combine Figures 4-12 The processing method of the in-vivo stone fragmentation system of this application is described in detail. The working principle of this application is as follows: By pre-mixing gels of varying viscosities and injecting them into the stone-bearing area via a catheter before performing lithotripsy, damage to the inner epithelium can be avoided if stone fragments accidentally detach during the procedure. The gel viscosity is calculated by the attending physician. The calculation principle in in vivo shockwave surgery is as follows: because the shockwave released by the electrode is in a cone shape, it follows the energy attenuation law; therefore, energy attenuation calculation formula 1 with dielectric absorption is used. ;in, The energy of the shock wave at a distance r from the electrode is... Energy starting point Shock wave energy at the location, The starting distance for measuring or defining shock wave energy, where r is the distance from the observation point to the electrode. It is the medium absorption coefficient.

[0066] Specifically, For normal energy attenuation with distance calculations, i.e., after the electrode generates a shock wave from... The energy from the energy starting point to the safe calculated distance *r* from the shock wave dissipation distance. However, when using a gel, energy attenuation increases due to medium absorption, therefore... It is e index, of which It is the medium absorption coefficient, and If the distance is the diffusion distance, then the entire formula is the reciprocal of the exponent of the constant e. Calculate the energy dissipation of the shock wave.

[0067] Compared to existing methods using physiological saline for energy absorption, it is clear that medium-to-high viscosity gels absorb more shock wave energy, such as water, which has a lower viscosity than... The absorption coefficient of medium-to-high viscosity gels (0.2) increases with distance, and the ratio of absorbed energy increases with distance. The device used here is the TCS-B-II in vivo shock wave lithotripter, whose shock wave energy is adjustable from 0.6 to 1 joule. With a fixed energy level, a corresponding table can be generated based on a formula, allowing for the direct preparation of different amounts of gel for energy absorption behind the stone. The absorption table is based on the distance the gel extends behind the stone. For example, when a 1 joule shock wave... Under the medium absorption coefficient, a filling distance of only 20mm is needed to absorb more than 97% of the energy, approximately 0.97J. This only considers the energy dissipation of the shock wave at the ideal point to the cone surface. In reality, the energy dissipation of the shock wave is faster, and the stone will absorb the vast majority of it.

[0068] Less than 30% of the energy is converted into ineffective shock waves. Of the shock wave energy absorbed by the stone, a very small portion will be broken into small stone fragments and fly away. More than half of this energy will be converted into the deformation and consumption of the stone, leaving less than 10%.

[0069] This portion of energy is converted into total kinetic energy. ,but Where (m / 1000) is the calculation from grams to kilograms. In the vector direction of the electrode shock wave emission, the smaller the volume, the less shock wave energy it receives; the energy distribution ratio is: , in, The kinetic energy gained by a single fragment of a kidney stone when it is ejected into the air. Let M be the total kinetic energy of all the flying fragments, and M be the approximate surface area of ​​the flying stone fragments facing the shock wave. It is the total area of ​​the cone shock wave spreading at the location of the stone fragments. The radius of the circle traversed by the base of the cone is used to calculate the kinetic energy of the gallstone fragments, as shown in Formula 2. , in, This indicates that the total area of ​​the cone's lateral surface formed by the diffusion of shock wave energy has been calculated. This indicates that the surface area of ​​a single fragment is calculated as a proportion of the total area of ​​the shock wave. Multiplying by this ratio means that the total kinetic energy of the debris is distributed to the fragment according to its area; this is the quantitative distribution. It is half the angle of the shock wave surface section.

[0070] Next, we will consider the calculation of the viscous resistance of the gel: ; in, It is the approximate radius of the fragment. It is the dynamic viscosity coefficient, which can be measured by a spherical viscosity meter. It is the initial velocity of the fragment, where Corresponding to Therefore, after converting to mm, it needs to be... Since the resistance changes with velocity, the work done by the resistance is... (where x is the distance the resistance does work) and the formula for kinetic energy change ,in This is the final velocity of the motion, which we set to 0 here. According to the work-energy theorem... Substituting into formula 2, we get formula 3: ; ; Formula 4 for calculating the stopping distance x of the fragment: ; Where M is used as an approximate surface area of ​​the impacted surface, it can be taken as half the surface area of ​​a sphere. To indicate, Then the formula can be simplified to ; ; Right now, ; in When the energy is equal to the electrode kinetic energy, the maximum safe distance can be determined.

[0071] As can be seen from the formula, the safe filling distance can be calculated by knowing only the electrode kinetic energy, the mass and radius of the stone, and the viscosity of the gel.

[0072] when When the energy is limited, the distance that all stone fragments can travel is also limited. The attending physician can calculate the size of the stone using color Doppler ultrasound CT, estimate the size of the fragmented stone based on the shape of the stone, and obtain the stone density based on stone sampling information from previous years. Substituting the size and mass of the stone fragments into Formula 4, the absolutely safe distance for gel filling can be determined.

[0073] The formulas can also be used to create a comparison table with formulas for different electrode power sizes, stone volumes, and safe distances for gel filling.

[0074] The following is under the same electrode conditions ( The safe distance under the condition that the initial distance of the flying debris is R=2 (with the angle fixed at 15 degrees).

[0075]

[0076] As can be seen from the above, under theoretical conditions, the output electrode power is completely absorbed by the stones within a distance of less than one millimeter after they are ejected and then stops.

[0077] Compared to the dynamic viscosity coefficient of water The value is only 0.001, which can be ignored. The corresponding calculation formula is not the formula derived above. However, when a gel with an extremely low viscosity coefficient greater than or equal to 1 is substituted, the safe distance will reach 13.2, 31, and 49.2 mm respectively. This is why the bile duct of patients is sometimes damaged and bleeding occurs during in vivo shock wave lithotripsy.

[0078] For holmium laser surgery, protein powder is mixed into the gel or glycerol is used to emulsify it to form a scattering area. When the holmium laser is used to cut the stone, the laser that is accidentally emitted will be dispersed in power due to the scattering of suspended particles, thus preventing burns to the cortex.

[0079] The stones are fixed and suspended in the gel, making them easier to break and adjust in angle. Since the energy of the holmium laser will eventually be converted into heat, the temperature limit of the gel can be controlled by calculating the specific heat capacity. Of course, the ideal method is to use a temperature-changing material, which will naturally change color or fade when the gel approaches 41 degrees Celsius, and can then be directly observed through an endoscope. However, no suitable pure biological material has been found yet. There are many non-biological materials, but they still need to be tested on animals before clinical trials can be conducted.

[0080] The approximate calculation of specific heat capacity is as follows: Where C is the specific heat capacity of the gel. ; Let w_water be the mass fraction of the i-th component (e.g., if water accounts for 90%, then w_water = 0.9). The specific heat capacity of the i-th component (See the manual for details).

[0081] The output time of the holmium laser can be calculated based on the injected gel mass and the power of the holmium laser.

[0082] Using biological staining agents to stain gels of different viscosities can also prevent mixing during gel injection, thus reducing the protective effect.

[0083] In summary, the gel injection method significantly reduces the likelihood of damage to the inner epithelium caused by high-voltage discharge lithotripsy and holmium laser lithotripsy. After injection, the gel solidifies and suspends the stones in their original position, allowing them to move only slightly even with continuous shockwave treatment. The fragmented stones also remain suspended within the gel, unlike previous procedures where they flow widely with fluids, making collection easier. Furthermore, the gel can be removed along with the fragments at the end of the procedure, especially when using a suction device, as the gel's high viscosity makes the fragments easier to remove.

[0084] Example 1 (e.g.) Figure 4-7 (as shown) When a patient with bile duct stones requires surgery, the attending physician first diagnoses the condition using ultrasound or CT scans and then arranges for preoperative preparation. When the stone is located in the gallbladder, a single-component gel is used for lithotripsy. However, when the stone is in the bile duct, there isn't enough space like the large space in the gallbladder where the gel can suspend the stone in the center. This could lead to displacement or fragmentation of the stone, potentially damaging the bile duct. Therefore, two types of gel with different viscosities are used. The more viscous gel serves as a base to fix the posterior part of the stone, while the less viscous gel is injected into the anterior part to prevent excessive agitation during electrode movement, which could displace the stone and affect treatment. Based on the stone size and the expected number of fragments, a table is consulted to adjust the electrode power and gel viscosity. After the treatment plan is finalized, the attending physician begins preparations for surgery. High-voltage shock wave lithotripsy procedure: Gel preparation. According to the doctor's instructions, the nurse prepares three to five gels of progressively higher viscosity directly in the operating room according to the gel preparation table. The gels are then stained with biological staining agents and classified as color A, color B, color C, etc. The staining should not be too dark, but light, to maintain the transparency of the gel.

[0085] The patient lies prone or on their left side. The doctor inserts a duodenoscope orally to the descending part of the duodenum, locates the papilla, and inserts a contrast catheter through the papilla. Under X-ray fluoroscopy, contrast agent fills the bile duct and pancreatic duct, locates the stone, and places a guidewire. The injection tube is then inserted into the bile duct along with the guidewire. Under direct visualization with the endoscope, the injection tube is guided along the endoscope to inject color A gel (high viscosity). During injection, the injection tube is gently moved to detach the stone from the bile duct wall (in previous surgeries, the stone would continuously move backward as shock waves were generated by electrode discharge) and suspend it in the color A gel. As little gel as possible is left on the front of the stone (this varies depending on the doctor's skill; if too much gel is left, it can be suctioned away). The amount of gel injected into the posterior part of the stone is approximately two to four times the volume of the stone; too much is wasteful, and too little may cause the stone to break out. At this point, the doctor injects color B low-viscosity gel. During injection, the syringe tip should be approximately 1 mm away from the stone. Because the two gels have different colors, the doctor should see color B gel adhering to the front of the stone when injecting. If not, the syringe tip should be moved forward until the gel adheres to the stone surface. Then, the syringe is moved backward while continuing to inject color B gel until the gel thickness exceeds 5 mm. After the gel injection is complete, the doctor withdraws the syringe and inserts a high-voltage discharge electrode to discharge and impact the stone. Due to the gel's viscosity, the stones shattered by the shockwave will not scatter like when flushed with saline solution, but will remain fixed in their original position. Even if some stones are ejected at excessive speed, the gel's viscosity will prevent them from moving very far. Because the viscosity of gel B is lower than that of gel A, the electrode movement will not cause excessive disturbance to the stone.

[0086] Because the shockwave emitted by the electrode is in a cone shape, stone fragments are prevented from flying to the rear of the electrode. As the electrode moves forward within the broken stone, it also pulls the B gel into the stone. Since the stone is suspended in the gel, the doctor can easily use the electrode to remove small fragments and break up larger pieces. Once the doctor has broken up the stone according to experience, the electrode can be withdrawn, and a suction tube can be inserted to remove the stone. At this point, the stone fragments in the bile duct are all suspended in the gel, so the doctor can simply aim at the AB gel with its two colors and suction it out to remove the stone. In previous surgeries, constant flushing with saline was required to remove all the stone fragments. For larger stones, a suction tube had to be inserted again to grab the larger particles. Because it was inside the body, the suction device could not use too much suction to draw out the saline, resulting in insufficient suction to remove the large particles.

[0087] After all the gel has been drawn out, the bile duct is rinsed again with saline solution. Because the AB gel is colored, it is easy to determine whether it has been rinsed clean. Even if micron-sized gel particles remain, they will be excreted through metabolism. However, if stones remain during treatment, they will regrow and become larger stones.

[0088] Example 2 (e.g.) Figure 8-12 (as shown) When a kidney stone patient needs to undergo holmium laser lithotripsy, the initial workflow is as described in Example 1. However, in gel preparation, it is necessary to prepare a semi-transparent C gel formed by emulsified protein mixed gel and a transparent staining D gel. The concentration of the emulsified gel needs to be adjusted according to the location of the stone. When the stone is located closer to the inner part of the renal calyx, a more concentrated gel can be prepared; when the stone is located in a larger cavity, a more transparent gel can be prepared. The C and D gels are also stained separately.

[0089] The specific surgical procedure is as described in Example 1. When injecting gel into the posterior part of the stone, gel C is injected into the posterior region of the stone in the direction of holmium laser irradiation, and then gel D is injected into the anterior part of the stone.

[0090] Similar to Example 1, once the stone is suspended within the renal calyx, the laser beam emitted by the physician will not shatter it into sand, thus preventing the stone removal process from being too slow. Compared to shock wave lithotripsy, the holmium laser has significantly higher power and generates more heat. When the holmium laser heats the gel above a certain body temperature, the gel's viscosity decreases. Furthermore, when the scattered light energy of the holmium laser heats the C gel, the emulsified particles within the gel disperse the laser beam, simultaneously heating all areas. This avoids damage to the renal calyx cortex behind the stone. While the gel's heat capacity is similar to water during continuous heating, it lacks the fluidity of pure saline solution. Therefore, after twenty seconds of continuous laser emission (calculated based on the laser's power and the gel's specific heat), a portion of the gel needs to be aspirated.

[0091] During the extraction process, the laser is first removed, and then the gel is aspirated using a suction tube. The aspirated gel also carries away the fragmented parts of the stone. After aspirating the gel, new gel is injected, and the stone-fracture process is repeated. Because the stone is suspended in the gel, the laser head can be easily adjusted in position and angle by manipulating it, achieving better stone-fracture results with fewer laser shots. There's no need to break the stone into tiny particles and then spend hours painstakingly cleaning up the fragments; as long as the fragments are smaller than the diameter of the gel suction tube, it's sufficient. After the doctor completes the stone-fracture, the gel containing the fragments is aspirated through the suction tube. After the gel is removed, the area is rinsed with saline solution, completing the procedure. Compared to existing holmium laser surgery procedures, although the step of changing the emulsified gel is added, the stone removal time is significantly reduced. It also reduces the osmotic pressure damage to the patient's kidneys caused by large amounts of saline flushing, resulting in excellent medical efficacy.

[0092] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0093] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "N" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0094] Any process or method described in the flowchart or otherwise herein can be understood as representing a module, segment, or portion of code comprising one or N executable instructions for implementing custom logic functions or processes, and the scope of the preferred embodiments of this application includes additional implementations in which functions may be performed not in the order shown or discussed, including substantially simultaneously or in reverse order depending on the functions involved, as should be understood by those skilled in the art to which embodiments of this application pertain.

[0095] It should be understood that the various parts of this application can be implemented using hardware, software, firmware, or a combination thereof. In the above embodiments, the N steps or methods can be implemented using software or firmware stored in memory and executed by a suitable instruction execution system. For example, if implemented in hardware, as in another embodiment, it can be implemented using any one or more of the following techniques known in the art: discrete logic circuits having logic gates for implementing logical functions on data signals, application-specific integrated circuits (ASICs) having suitable combinational logic gates, programmable gate arrays (PGAs), field-programmable gate arrays (FPGAs), etc.

[0096] Those skilled in the art will understand that all or part of the steps of the methods in the above embodiments can be implemented by a program instructing related hardware. The program can be stored in a computer-readable storage medium, and when executed, the program includes one or a combination of the steps of the method embodiments.

Claims

1. A device for breaking up stones inside the body, characterized in that, include: A gel supply device for providing biocompatible gels of various viscosities; A gel injection device, connected to the gel supply device via a catheter, is used to inject a gel of a target viscosity into the area of ​​the patient's body where the stones are located. A lithotripsy device for crushing stones in the gel-filled environment; A gel suction device is used to extract the broken stone fragments along with the gel. The processing unit is communicatively connected to the gel supply device, the gel injection device, the gel suction device, and the lithotripsy device. It is used to acquire the property parameters of the target stone and the energy parameters of the lithotripsy device, and to calculate the target viscosity of the gel and / or the safe distance for gel filling based on the property parameters of the target stone and the energy parameters of the lithotripsy device.

2. The internal stone-breaking device according to claim 1, characterized in that, The gel supply device includes: at least one container holding different base gel raw materials and at least one driving component, wherein, The drive component is used to mix at least one base gel raw material in the container to prepare a gel with a target viscosity.

3. The internal stone-breaking device according to claim 1, characterized in that, The gel supply device further includes a staining agent addition module for adding different biological staining agents to gels of different viscosities to generate visual distinctions.

4. The internal stone-breaking device according to claim 1, characterized in that, The gel injection device further includes a dual-lumen catheter with visual markings, wherein the first lumen of the dual-lumen catheter is used to inject gel with a viscosity greater than or equal to a preset viscosity, and the second lumen is used to inject gel with a viscosity less than the preset viscosity.

5. The internal stone-breaking device according to claim 1, characterized in that, When the lithotripsy device is a holmium laser, the gel supplied by the gel supply device is an emulsified gel containing scattering particles.

6. An internal stone fragmentation system, characterized in that, include: The internal stone fragmentation device as described in any one of claims 1-5; A controller electrically connected to the in vivo stone breaking device is used to control the gel supply device to dispense gel of a target viscosity, and to control the gel injection device to inject gel of the target viscosity into the area of ​​the stone in the patient's body according to the gel filling safety distance.

7. A method for treating internal stones using a stone-breaking system, characterized in that, The method is applied to the in vivo stone fragmentation system of claim 6, and the method includes the following steps: Obtain the attribute parameters of the target stone and the energy parameters of the lithotripsy equipment; The target viscosity of the gel and the safe distance for gel filling are calculated based on the property parameters of the target stone and the energy parameters of the lithotripsy device. The in vivo stone-breaking system is controlled to perform corresponding operations based on the target viscosity of the gel and the safe distance for gel filling.

8. The treatment method of the in vivo stone fragmentation system according to claim 7, characterized in that, The step of calculating the target viscosity of the gel based on the property parameters of the target stone and the energy parameters of the lithotripsy device includes: Obtain a first mapping table, wherein the first mapping table is a mapping relationship between the attribute parameters of the target stone, the energy parameters of the lithotripsy device, and the target viscosity of the gel; The target viscosity of the gel is determined by querying a first mapping table using the attribute parameters of the target stone and the energy parameters of the lithotripsy device as indexes.

9. The treatment method of the in vivo stone fragmentation system according to claim 7, characterized in that, The calculation of the gel filling safety distance based on the property parameters of the target stone and the energy parameters of the lithotripsy device includes: ； in, For electrode kinetic energy, Let be the approximate radius of the fragment. The dynamic viscosity coefficient, Let m be the energy dissipation angle, and m be the mass of the stone in the patient's body. The radius of the cavity at the site of the stone.

10. The treatment method of the in vivo stone fragmentation system according to claim 7, characterized in that, The step of controlling the in vivo stone fragmentation system to perform corresponding operations based on the target viscosity of the gel and the safe distance for gel filling includes: Prepare a biocompatible gel with a corresponding viscosity value according to the target viscosity of the gel; A gel of the target viscosity is injected in stages into the anterior and posterior regions of the stone using a dual-lumen catheter, wherein the gel filling thickness injected into the posterior region of the stone is greater than or equal to the gel filling safety distance.

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