Training system for minimally invasive surgery of kidney stones, training method and manufacturing method for kidney model

Abstract

The application provides a training system for kidney stone minimally invasive surgery, a training method and a manufacturing method of a kidney model. The training system comprises a kidney model, an image acquisition device, a flexible piezoresistive sensor, a host computer and a display device. The kidney model is internally provided with a stone and a kidney pelvis filled with water. The image acquisition device is arranged at one end of a surgical instrument, used to enter the kidney model with the surgical instrument and acquire an intrarenal image. The flexible piezoresistive sensor is attached to the inner wall of the kidney pelvis near the abdominal side, used to generate an electrical signal according to the water pressure data in the kidney pelvis when the surgical instrument enters the kidney model. The host computer is used to analyze the electrical signal to obtain an intrarenal pressure parameter. The display device is used to perform a training task of the target level kidney stone minimally invasive surgery, obtain a position parameter of the surgical instrument in the kidney model according to the intrarenal image, and display the intrarenal pressure parameter and the position parameter in real time, so that a user operates the stone with the surgical instrument and evaluates the operation.

Description

Technical Field

[0001] This application relates to the fields of medical device testing, surgical training, and 3D printed organ models, specifically to a training system and method for minimally invasive surgery for kidney stones, and a method for manufacturing a kidney model. Background Technology

[0002] Kidney stones are a common disease of the urinary system, and their treatment has gradually shifted from open surgery to minimally invasive surgery, primarily flexible ureteroscopic lithotripsy (FURS) and percutaneous nephrolithotomy (PCNL). Minimally invasive kidney stone surgery requires operating endoscopes and surgical instruments within the confined space of the kidney and necessitates real-time monitoring of intrarenal pressure changes. Therefore, developing a training system for minimally invasive kidney stone surgery is crucial for shortening the learning cycle and ensuring surgical safety. However, current training systems exhibit poor skill transfer effects and struggle to detect key physiological parameters during the procedure. Summary of the Invention

[0003] In view of the above problems, embodiments of this application provide a training system, training method, and method for manufacturing a kidney model for minimally invasive surgery for kidney stones.

[0004] According to a first aspect of the embodiments of this application, a training system for minimally invasive surgery for kidney stones is provided, including a kidney model, an image acquisition device, a flexible piezoresistive sensor, a host computer, and a display device. The kidney model contains a stone and a renal pelvis filled with water. The image acquisition device is disposed at one end of a surgical instrument and is used to enter the kidney model with the surgical instrument and acquire images within the kidney. The flexible piezoresistive sensor is attached to the inner wall of the renal pelvis near the abdomen within the kidney model and is used to generate an electrical signal based on the water pressure data within the renal pelvis when the surgical instrument enters the kidney model. The host computer is used to analyze the electrical signal to obtain intrarenal pressure parameters. The display device is used for training tasks of minimally invasive kidney stone surgery based on target levels. Based on the intrarenal images, it obtains the positional parameters of the surgical instrument within the kidney model and displays the intrarenal pressure parameters and positional parameters in real time, so that the user can operate on the stone using the surgical instrument and evaluate the operation.

[0005] According to embodiments of this application, the training system further includes a bladder model and a hip cavity model. The bladder model is connected to the ureter of the kidney model. The bladder model has a urethral end for providing an entry channel for surgical instruments during ureteroscopic lithotripsy. The hip cavity model is used to fix the kidney and bladder models. A strip-shaped opening is provided on one side of the hip cavity model to provide a puncture channel for surgical instruments during percutaneous nephrolithotomy.

[0006] According to an embodiment of this application, the target level of the training task is determined based on the size, number, and location of the stones in the kidney model.

[0007] According to an embodiment of this application, when the target level is the first level, the size of the stones in the kidney model is between 5mm and 10mm, the number of stones is between 1 and 2, and the stones are located in the first region of the renal pelvis. The training task for ureteroscopic lithotripsy is based on the stones.

[0008] According to an embodiment of this application, when the target level is the second level, the size of the stones in the kidney model is between 10mm and 15mm, the number of stones is between 2 and 3, and at least one stone is located in the second region of the renal pelvis. The training task for percutaneous nephrolithotomy is based on the stones.

[0009] According to an embodiment of this application, when the target level is level three, the size of the stones in the kidney model is between 15mm and 20mm, the number of stones is three, and at least one stone is located in the third region of the renal pelvis. The training task for percutaneous nephrolithotomy is based on the stones.

[0010] According to an embodiment of this application, the training system further includes an oscilloscope. The oscilloscope is connected to a host computer. The oscilloscope is used to display the waveform curves of the intrarenal pressure parameters obtained by the host computer.

[0011] According to an embodiment of this application, the flexible piezoresistive sensor includes a flexible strain layer, a flexible encapsulation layer, and a flexible substrate layer. The flexible piezoresistive sensor transmits electrical signals to a host computer via an external circuit board and a data acquisition card.

[0012] According to a second aspect of the embodiments of this application, a method for manufacturing a kidney model for a training system for minimally invasive kidney stone surgery described above is provided. The method includes: injecting a first silicone material into a renal pelvis casting model, and demolding it after curing to obtain a renal pelvis model; positioning the renal pelvis model in a renal parenchyma casting model, and injecting a second silicone material into the renal parenchyma casting model; the elastic modulus of the first silicone material is higher than that of the second silicone material; and after the second silicone material has cured, separating the renal pelvis model from the second silicone material to obtain a kidney model.

[0013] According to a third aspect of the embodiments of this application, a training method is provided using the above-described training system for minimally invasive kidney stone surgery. The training method includes: acquiring intrarenal images in a kidney model; setting up a kidney model containing stones and a renal pelvis filled with water; acquiring water pressure data within the renal pelvis while surgical instruments are inserted into the kidney model; obtaining intrarenal pressure parameters based on electrical signals generated from the water pressure data; obtaining positional parameters of the surgical instruments within the kidney model based on the intrarenal images; and displaying the intrarenal images, intrarenal pressure parameters, and positional parameters in real time based on a training task for minimally invasive kidney stone surgery at a target level, so that the user can manipulate the stones in the kidney model using surgical instruments and evaluate the manipulation.

[0014] According to embodiments of this application, a training system for minimally invasive kidney stone surgery is provided. This training system utilizes a kidney model constructed with stones and a fluid-filled renal pelvis, improving the simulation accuracy of the training system and providing users with a highly realistic training environment, thereby enhancing the skill transfer effect. Simultaneously, by using a flexible piezoresistive sensor and a host computer to monitor the key physiological parameter of intrarenal pressure in real time, and combining this with image acquisition equipment to acquire intrarenal images and obtain positional parameters, the objectivity and comprehensiveness of the operation can be improved during training, further enhancing the skill transfer effect. Attached Figure Description

[0015] The above-mentioned contents, other objects, features and advantages of this application will become clearer from the following description of embodiments with reference to the accompanying drawings, in which:

[0016] Figure 1 A schematic diagram of a minimally invasive kidney stone surgery training system according to an embodiment of this application is shown.

[0017] Figure 2 A schematic diagram of a kidney model of a minimally invasive kidney stone surgery training system according to an embodiment of this application is shown.

[0018] Figures 3-6 The diagrams illustrate the bladder model and the hip cavity model of the kidney stone minimally invasive surgery training system according to embodiments of this application.

[0019] Figure 7 This schematically illustrates a perspective view of a kidney model used for a training task in ureteroscopic lithotripsy according to an embodiment of this application.

[0020] Figure 8 The illustration schematically shows a perspective view of a kidney model during a training task for percutaneous nephrolithotomy according to an embodiment of this application;

[0021] Figure 9 A schematic diagram of the structure of a flexible piezoresistive sensor according to an embodiment of this application is shown.

[0022] Figure 10 A schematic 3D model diagram of a kidney model according to an embodiment of this application is shown.

[0023] Figure 11 A schematic diagram of a 3D model of the renal pelvis of a kidney model according to an embodiment of this application is shown.

[0024] Figure 12 A flowchart illustrating a method for preparing a kidney model according to an embodiment of this application is shown schematically.

[0025] Figure 13 A schematic diagram of a renal pelvis casting model of a kidney model according to an embodiment of this application is shown.

[0026] Figure 14 This schematic diagram illustrates a cast model of renal parenchyma according to an embodiment of the present application.

[0027] Figure 15 An exploded view of a cast model of a kidney model according to an embodiment of this application is shown schematically.

[0028] Figure 16 A flowchart illustrating a training method for a training system for minimally invasive kidney stone surgery according to an embodiment of this application is shown.

[0029] Figure 17 An ultrasound image of a kidney model according to an embodiment of this application is shown schematically. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with specific embodiments and the accompanying drawings.

[0031] The endpoints and any values ​​of the ranges disclosed in this application are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed in this application.

[0032] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of this application. The terms “comprising,” “including,” etc., as used herein indicate the presence of the stated features, steps, operations, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, or components.

[0033] All terms used herein (including technical and scientific terms) have the meanings commonly understood by those skilled in the art, unless otherwise defined. It should be noted that the terms used herein are to be interpreted in a manner consistent with the context of this specification, and not in an idealized or overly rigid way.

[0034] In the description of this application, it should be understood that the terms "longitudinal", "length", "circumferential", "front", "rear", "left", "right", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the subsystem or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0035] Similarly, to simplify this application and aid in understanding one or more of the various disclosed aspects, in the above description of exemplary embodiments of this application, various features of this application are sometimes grouped together into a single embodiment, figure, or description thereof. The use of terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicates 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, 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.

[0036] Kidney stones are a common disease of the urinary system, and the mainstream treatment has shifted from open surgery to minimally invasive surgery, among which flexible ureteroscopic lithotripsy (FURS) and percutaneous nephrolithotomy (PCNL) are particularly important. Minimally invasive kidney stone surgery requires delicate procedures and a steep learning curve, demanding proficiency in operating endoscopes and surgical instruments within the confined space of the kidney, while also requiring keen awareness of changes in intrarenal pressure. Excessively high intrarenal pressure is a key risk factor for serious complications such as postoperative infection and sepsis. Therefore, an efficient and reliable surgical training system is crucial for shortening the learning period and ensuring surgical safety.

[0037] Currently, training for minimally invasive kidney stone surgery primarily relies on the following methods. One is traditional animal testing. While traditional animal testing can provide a relatively realistic tissue feel, it faces ethical controversies, high costs, significant differences in anatomical structure compared to humans, and the inability to reuse the models. Another method is physical simulation models based on commercially available synthetic materials. Although physical simulation models can simulate basic anatomical forms, they generally suffer from the following problems: First, the mechanical properties (such as hardness, elasticity, or toughness) of the materials used in the simulation models in the relevant examples differ significantly from those of real human kidney tissue, failing to provide users with a realistic tissue contact feel and instrument feedback, resulting in poor skill transfer. Second, the simulation models in the relevant examples can only mechanically repeat the surgical procedure, unable to objectively and quantitatively monitor and provide feedback on key physiological parameters (such as intrarenal pressure) during the surgery, resulting in a lack of comprehensive, objective, and scientific evaluation of the training process.

[0038] Furthermore, with the development of flexible electronics technology, integrating sensors into bionic phantoms for intelligent training has become a cutting-edge research direction. The sensors in related examples are typically based on traditional elastomers (such as PDMS), which face severe challenges to their mechanical durability and long-term stability under long-term, repeated contact with instruments and water flow. Moreover, these sensors are often simply added as independent modules, failing to achieve structural and functional integration with the bionic phantom.

[0039] In view of this, embodiments of this application provide a training system, training method, and method for manufacturing a kidney model for minimally invasive kidney stone surgery. This training system and method provide a high-fidelity, fully immersive training environment for minimally invasive kidney stone surgery, while utilizing flexible piezoresistive sensors to monitor intrarenal pressure parameters in key areas during surgery in real time and dynamically, thereby achieving high-quality surgical training and objective, quantitative surgical evaluation.

[0040] Figure 1 A schematic diagram of a minimally invasive kidney stone surgery training system according to an embodiment of this application is shown.

[0041] like Figure 1 As shown, the training system for minimally invasive kidney stone surgery in this embodiment may include a kidney model, an image acquisition device, a flexible piezoresistive sensor, a host computer, and a display device.

[0042] The image acquisition device can be set at one end of the surgical instrument to enter the kidney model along with the surgical instrument and acquire images inside the kidney.

[0043] In specific embodiments, surgical instruments may include a flexible ureteroscope, a percutaneous nephroscope, a stone retrieval basket, and a puncture needle. The image acquisition device may be a camera mounted on the tip of the flexible ureteroscope or percutaneous nephroscope. The image acquisition device may be configured to acquire intrarenal images within a renal model. Alternatively, the intrarenal images may be ultrasound images acquired using ultrasound equipment.

[0044] Figure 2 A schematic diagram of a kidney model of a kidney stone minimally invasive surgery training system according to an embodiment of this application is shown.

[0045] like Figure 2 As shown, the kidney model may include renal parenchyma 8, renal pelvis 9, and ureter 91. The renal pelvis 9 may include major calyces 92 and minor calyces 93, etc. The kidney model may be a 3D model made of silicone material.

[0046] The kidney model can include stones and a water-filled renal pelvis. The stones can be modeled using polyethylene terephthalate (PETG). Depending on the training task's target level, the stones can be set to different sizes, shapes, and locations within the kidney model. The water-filled renal pelvis simulates the renal tissue environment, improving the simulation accuracy of the training system.

[0047] The flexible piezoresistive sensor 10 can be attached to the inner wall of the renal pelvis 9 near the abdomen inside the kidney model. Because the renal pelvis has a small internal volume and the pressure deviation at different locations is small, the accuracy of the data obtained by attaching the flexible piezoresistive sensor 10 to this location meets the measurement requirements. When surgical instruments are inserted into the kidney model, the flexible piezoresistive sensor 10 can generate an electrical signal based on the water pressure data within the renal pelvis 9. The electrical signal may include the resistance signal collected by the flexible piezoresistive sensor.

[0048] The host computer can be used to analyze electrical signals to obtain intrarenal pressure parameters. The formula for analyzing electrical signals into intrarenal pressure parameters within the host computer is shown below.

[0049] (1)

[0050] In formula (1), ρ represents the intrarenal pressure parameter, with units of centimeters of water column (cmH2O), and S represents the sensor sensitivity, with units of cmH2O. －1 R0 represents the initial resistance of the sensor. This is expressed as the change in resistance of the sensor during actual testing.

[0051] The expression for sensor sensitivity is shown below.

[0052] (2)

[0053] (3)

[0054] In formulas (2) and (3), R p R0 represents the sensor resistance at pressure p during sensor calibration, R0 represents the initial resistance of the sensor, Δp represents the relative pressure change during sensor calibration, and the sensitivity S is a constant after sensor calibration, which can be input to the host computer during actual testing.

[0055] The display device can be used for training tasks of minimally invasive kidney stone surgery based on target levels. Based on the intrarenal images, it obtains the positional parameters of the surgical instruments within the kidney model and displays the intrarenal pressure and positional parameters in real time, so that users can operate on the stones using the surgical instruments and evaluate the operation.

[0056] The display device may include an external monitor. It can display surgical images in real time, including intrarenal images, intrarenal pressure parameters, and positional parameters. The device can also record surgical images and analyze indicators such as surgical time and instrument positioning. Positional parameters can be obtained from intrarenal images. These parameters may include the spatial positional parameters of surgical instruments and stones.

[0057] In a specific embodiment, the intrarenal pressure parameters may include at least one of the following: maximum water pressure, average water pressure, water pressure integral, maximum water pressure change rate, and pressure error count. Maximum water pressure can be the highest water pressure value during the entire surgical procedure, measured in cmH2O. Average water pressure can be the average water pressure value during the entire surgical procedure, measured in cmH2O. Water pressure integral can be the cumulative water pressure over time during the entire surgical procedure, measured in cmH2O·s. Maximum water pressure change rate can be expressed as the maximum magnitude of water pressure change caused by changes in the injection flow rate during the surgical procedure, measured in cmH2O / s. Pressure error count can be expressed as the number of times the water pressure exceeds a predetermined threshold during the surgical procedure, measured in times. The predetermined threshold can be set to 180 cmH2O.

[0058] The display device can also display evaluation metrics during the operation. Evaluation metrics may include surgical operation time metrics and instrument positioning metrics. Surgical operation time may include at least one of the following: stone finding time, lithotripsy time, and total surgical time. Instrument positioning metrics may include at least one of the following: target positioning accuracy metrics, path planning adjustment frequency metrics, and instrument coordination metrics.

[0059] Stone-finding time can be measured in seconds (s) or the time from the initial insertion of the flexible ureteroscope to successful entry into the target renal pelvis, or from the initial insertion of the puncture needle to successful entry of the percutaneous nephroscope into the target renal pelvis.

[0060] The lithotripsy time is the time required for a single laser lithotripsy session from activation to complete stone fragmentation, measured in seconds.

[0061] The total surgical time is the time taken to complete all the procedures, measured in seconds (s).

[0062] The accuracy of target positioning can be measured in mm, which can be the spatial deviation between the laser fiber or stone retrieval basket and the stone, or the spatial deviation of the puncture needle in positioning the renal pelvis.

[0063] The path planning adjustment frequency index can be defined as the number of redundant movements in the movement path of flexible endoscopes and lithotripsy instruments within the kidney model, expressed in times.

[0064] Instrument coordination indicators can be used to measure the synchronization and smoothness of operating surgical instruments such as flexible endoscopes, puncture needles, lasers, and stone retrieval baskets.

[0065] According to embodiments of this application, a training system for minimally invasive kidney stone surgery is provided. This training system utilizes a kidney model constructed with stones and a fluid-filled renal pelvis, improving the simulation accuracy of the training system and providing users with a highly realistic training environment, thereby enhancing the skill transfer effect. Simultaneously, by using a flexible piezoresistive sensor and a host computer to monitor the key physiological parameter of intrarenal pressure in real time, and combining this with intrarenal images acquired by an image acquisition device to obtain positional parameters, the objectivity and comprehensiveness of the operation can be improved during training, further enhancing the skill transfer effect.

[0066] Figures 3-6 The diagrams schematically illustrate the bladder model and the hip cavity model of the kidney stone minimally invasive surgery training system according to embodiments of this application. It should be noted that... Figure 3 This diagram illustrates the external view of a model of the hip cavity. Figure 4 The diagram illustrates the structural breakdown of the hip cavity model and the bladder model. Figure 5 and Figure 6 The top and left views of the hip cavity model are shown respectively.

[0067] like Figures 3-6 As shown, the training system of this embodiment may further include a bladder model 24 and a hip cavity model 15. The hip cavity model 15 can be used to fix the kidney model and the bladder model 24.

[0068] The hip cavity model 15 may have a surgical observation window 18 at the abdomen, covered by a transparent cover 26. The kidney model can be replaced or adjusted during preoperative preparation via the surgical observation window 18. During the surgical procedure, the internal abdominal condition can be observed through the transparent cover 26. A support base plate 28 may be provided at the bottom of the hip cavity model 15. The support base plate 28 can be angled to adjust the position of the hip cavity model 15; the angle adjustment range can be set to 0~15°, and the specific angle can be set according to the surgical situation.

[0069] The hip cavity model 15 may also include a left hip joint 19 and a right hip joint 20.

[0070] Continue to refer to Figures 3-6 The hip cavity model 15 also houses a spine model 16 for positioning and supporting the kidney model. Ureteral supports 17 and 22, along with a bladder support 21, secure the bladder model 24 to the pelvic region of the hip cavity model 15. The bladder model 24 may have a urethral end 23, which connects to the ureter of the kidney model via a pagoda-shaped interface 25, providing an entry channel for surgical instruments and preventing leakage during ureteroscopic lithotripsy.

[0071] A Luer valve is installed on the urethral end 23 of the bladder model 24, which can lock the urethral end 23 after the kidney model is filled with water to prevent leakage from affecting the accuracy of intrarenal pressure parameter measurement. The kidney model support 27 is fixed to one side of the spinal model 16 for positioning the kidney model. It can be fixed to the left, right, or both sides of the spinal model according to the needs of the training task. The ureteral end of the renal pelvis 9 can be connected to the ureteral end 23 of the bladder model 24 through the pagoda interface 25 to realize the integration of the urinary system of the phantom.

[0072] Before the surgical procedure, the bladder model 24 can be fixed to the bladder model support 21, the ureter can be fixed to the ureter supports 17 and 22, and the urethral end 23 can extend out of the small hole at the lower end of the hip cavity model 15 to complete the positioning of the bladder model 24. The kidney model support 27 can be fixed to the left, right, or both sides of the spine model 16 with screws.

[0073] Continue to refer to Figure 6 The hip cavity model 15 has a strip-shaped opening 29 on one side of the waist to provide a puncture channel for surgical instruments during percutaneous nephrolithotomy.

[0074] According to embodiments of this application, by fixing kidney and bladder models inside a hip cavity model, a fully integrated immersive training system with high simulation fidelity is constructed, encompassing the kidney, bladder, and ureter. The hip cavity model also features a percutaneous nephrolithotomy puncture site, enabling users to replicate the entire procedure of minimally invasive kidney stone surgery, further enhancing skill transfer.

[0075] In a specific embodiment, the target level of the training task can be determined based on the size, number, and location of the stones in the kidney model.

[0076] The target level characterizes the difficulty of a training task for minimally invasive kidney stone surgery. The difficulty level is determined by setting the size, number, and location of the stones within the kidney model. Stone size, or stone load, can be represented by the longest diameter of the stone.

[0077] Based on the difficulty of the training tasks, target levels can be set from easy to difficult as Level 1, Level 2, and Level 3, etc.

[0078] When the target grade is Level 1, the size of the stones in the kidney model can be set between 5mm and 10mm, and the number of stones can be set between 1 and 2. The stones are located in the first region of the renal pelvis. The first region of the renal pelvis can be the middle of the greater calyx and the side closest to the renal pelvis.

[0079] When the target level of the training task is set to Level 1, users can perform training tasks for ureteroscopic lithotripsy based on stones.

[0080] Figure 7 A perspective view of a kidney model is schematically shown during a training task for ureteroscopic lithotripsy according to an embodiment of this application.

[0081] like Figure 7 As shown, firstly, the guidewire 31 can be inserted into the bladder model through the urethra and then into the renal pelvis 9 of the kidney model via the ureter. Next, the access sheath 32, guided by the guidewire 31, is inserted into the renal pelvis 9 to dilate the insertion path of surgical instruments, such as the flexible ureteroscope 33. Subsequently, the flexible ureteroscope 33 can be inserted into the renal pelvis 9 through the access sheath 32, and water is injected to dilate the renal pelvis 9 in the renal parenchyma 8, so that the searchlight at the tip of the flexible ureteroscope 33 and image acquisition devices such as cameras can be used to explore for stones 30. Finally, surgical instruments such as laser instruments are inserted to fragment the stones. After removing larger stones using a stone retrieval basket, the pump water pressure can be adjusted to flush away the remaining fragments to complete the surgical procedure.

[0082] When the target grade is Level 2, the size of the stones in the kidney model can be set to between 10mm and 15mm, and the number of stones can be set to between 2 and 3. At least one stone is located in the second region of the renal pelvis. The second region of the renal pelvis can be the calyx of the middle calyx of the kidney.

[0083] When the target level of the training task is set to Level 2, users can perform training tasks for percutaneous nephrolithotomy based on stones.

[0084] Figure 8 A perspective view of a kidney model during a training task for percutaneous nephrolithotomy according to an embodiment of this application is schematically shown.

[0085] like Figure 8As shown, firstly, water is injected into the kidney model to fill the renal pelvis 9 within the renal parenchyma 8. Ultrasound imaging is then used to visualize the internal structure of the kidney model. Next, the puncture site of the puncture needle 34 is located based on the intrarenal image. After successful puncture, the lithotripsy instrument 35 is inserted through the puncture needle 34 into the kidney model to perform lithotripsy. Finally, the lithotripsy fragments are expelled through the ureter to complete the surgical procedure.

[0086] Kidney models can be prepared using silicone material. The puncture hole created after puncture will automatically close due to the elasticity of the silicone material. Therefore, kidney models can be punctured multiple times while ensuring normal performance.

[0087] When the target grade is level three, the size of the stones in the kidney model can be set between 15mm and 20mm, and the number of stones can be set to three. At least one stone is located in the third region of the renal pelvis. The third region of the renal pelvis can be the lesser calyx of the lower calyx.

[0088] When the target level of the training task is set to Level 3, users can perform training tasks for percutaneous nephrolithotomy based on stones.

[0089] According to the embodiments of this application, the training system of this embodiment can be set with different levels of training tasks, and can be used for training in two mainstream minimally invasive kidney stone surgeries: ureteroscopic lithotripsy and percutaneous nephrolithotomy. It is not only suitable for the skills training of urologists, but can also be used as a testing platform for the development and verification of surgical robots and related medical device technologies.

[0090] In a specific embodiment, the training system may further include an oscilloscope. The oscilloscope can be connected to a host computer to display the waveform curves of the intrarenal pressure parameters obtained by the host computer. The host computer can be configured with a data conversion program capable of converting the sensor's electrical signals into intrarenal pressure parameters and displaying them on the oscilloscope in real time.

[0091] According to an embodiment of this application, the host computer can convert the electrical signals collected by the sensor into intrarenal pressure parameters, and convert the electrical signals into pressure data curves through a data conversion program and display them on an oscilloscope, so that users can intuitively monitor the changes in intrarenal pressure parameters through the oscilloscope and realize real-time and visualized output of intrarenal pressure.

[0092] In a specific embodiment, the training system of this embodiment, in addition to displaying pressure data curves on an oscilloscope, can also display the key physiological parameter of intrarenal pressure in real time on a display device. It integrates quantitative indicators such as maximum water pressure, average water pressure, and water pressure integral to provide data support for evaluating operational safety. Combined with indicators such as operation time and instrument positioning accuracy based on visual feedback, this constitutes a comprehensive and objective skill evaluation method.

[0093] Figure 9 A schematic diagram of the structure of a flexible piezoresistive sensor according to an embodiment of this application is shown.

[0094] like Figure 9 As shown, the flexible piezoresistive sensor may include a flexible strain layer 11, a flexible encapsulation layer 12, and a flexible substrate layer 14. The flexible strain layer 11 may include polyimide. The flexible encapsulation layer 12 may be a stack composed of epoxy resin and polyimide. The flexible substrate layer 14 may include a PET film. The flexible piezoresistive sensor can transmit the acquired electrical signals via a flexible printed circuit board (FPC) cable 13.

[0095] In a specific embodiment, the flexible piezoresistive sensor can sense pressure signals of 0~230cmH2O, with a response time of less than or equal to 0.5s at pressures of 0~18kPa, an average response time of 27.7ms / kPa, and a resolution of up to 20Pa for minute pressures.

[0096] The flexible piezoresistive sensor can acquire electrical signals in real time and transmit them to a host computer via an external circuit board and data acquisition card. The sensor connects the electrical signal to a cable adapter board via an FPC cable, and then to an external circuit board via DuPont wires. The circuit board may include a power module, a bridge module, an amplification module, and a filtering module, enabling stable and accurate transmission of the electrical signal to the data acquisition card, which ultimately transmits the data to the host computer.

[0097] According to embodiments of this application, a flexible piezoresistive sensor based on polyimide and epoxy resin is integrated inside a kidney model. With the excellent mechanical strength of polyimide and the robust encapsulation protection of epoxy resin, it can withstand the physical contact of surgical instruments and the long-term impact of irrigation water flow, ensuring the long-term stability and reliability of electrical signals in a humid and dynamic surgical simulation environment.

[0098] Figure 10 A schematic 3D model diagram of a kidney model according to an embodiment of this application is shown. Figure 11 A schematic diagram of a 3D model of the renal pelvis of a kidney model according to an embodiment of this application is shown.

[0099] like Figure 10 and Figure 11 As shown, a 3D model of the kidney can be obtained from human kidney CT scan data, including the renal parenchyma, renal pelvis (major calyces, minor calyces, ureter, etc.). Based on human kidney CT scan data, the kidney length can be 11.2 cm, the kidney thickness 3.6 cm, the kidney width 5.8 cm, and the size of the minor calyces 8 mm to 11 mm. The renal pelvis volume is 5.2 mL, the ureteral endoscope diameter is 5.1 mm, and the ureteral outer diameter is 10.2 mm.

[0100] Figure 12 A flowchart illustrating a method for preparing a kidney model according to an embodiment of this application is shown. Figure 13 A schematic diagram of a renal pelvis casting model of a kidney model according to an embodiment of this application is shown. Figure 14 A schematic diagram of a cast model of renal parenchyma according to an embodiment of this application is shown. Figure 15 An exploded view of a cast model of a kidney model according to an embodiment of this application is shown schematically.

[0101] like Figure 12 As shown, the method for manufacturing a kidney model for a training system for minimally invasive kidney stone surgery in this embodiment may include operations S1210 to S1230.

[0102] In operation S1210, the first silicone material is injected into the renal pelvis casting model, and after curing, the model is demolded to obtain the renal pelvis model.

[0103] like Figures 13-15 As shown, casting models can be designed in modeling software and manufactured using 3D printing, including the renal pelvis casting model 6 and the left renal wall model 1 and right renal wall model 2 of the renal parenchyma casting model. The left renal wall model 1 and right renal wall model 2 represent the left and right walls of a single kidney, and users can design the left or right kidney model according to specific needs.

[0104] The renal pelvis casting model 6 can be printed from a 3D model of the renal pelvis. The interior is a renal pelvis cavity, and the exterior has two casting holes. The two casting holes are provided for two reasons: firstly, to facilitate casting, and secondly, because the two casting holes are located at the highest point of the internal cavity of the renal pelvis casting model in the vertical direction, the principle of communicating vessels can be used to reduce the amount of air bubbles left during the casting process.

[0105] In a specific embodiment, the first silicone material can be slowly injected into the renal pelvis casting model. The first silicone material can be modulated to have a high elastic modulus, and after curing and demolding, a renal pelvis model with a relatively hard material can be obtained.

[0106] In operation S1220, the renal pelvis model is positioned in the renal parenchyma casting model, and a second silicone material is injected into the renal parenchyma casting model.

[0107] Continue to refer to Figure 14 and Figure 15The renal parenchyma casting model can be printed from a 3D model of the renal parenchyma. The main body of the model consists of a left renal wall model 1 and a right renal wall model 2. The interior of the model is a cavity representing the kidney structure, with annular grooves along the edges for placing silicone rings as sealing strips for the left and right sections of the casting model. The ureter 5 can be divided into inner and outer parts, casting a tubular structure of the ureter, and is equipped with two positioning pins 4 and a positioning cap 3 to position the internal renal pelvis model 6 and seal the casting port. A fixed base 7 is located at the bottom of the renal parenchyma casting model. The model can be fixed at its four corners with M8 screws and nuts and placed on the fixed base 7.

[0108] In a specific embodiment, the renal pelvis model 6 can be positioned within the ureter 5 of the renal parenchyma casting model, and then both can be positioned on the renal parenchyma casting model using positioning pins 4. The second silicone material can be slowly injected into the renal parenchyma casting model. The elastic modulus of the first silicone material can be higher than that of the second silicone material, i.e., the second silicone material is modified to have a lower elastic modulus. After casting, the casting port can be sealed using a positioning cap 3.

[0109] During operation S1230, after the second silicone material has cured, the renal pelvis model is separated from the second silicone material to obtain the kidney model.

[0110] In a specific embodiment, after the second silicone material has cured, the external renal parenchyma casting model and the internally embedded renal pelvis casting model can be demolded by utilizing the difference in their elastic moduli, thereby obtaining a kidney model with internal cavity structures such as the renal pelvis, major calyx, minor calyx, and ureter.

[0111] According to embodiments of this application, the kidney model manufactured by the above-described method exhibits a high degree of similarity to real kidney tissue in key physicochemical properties such as hardness and elastic modulus, thereby enhancing the simulation accuracy of surgical procedures. The kidney model accurately reconstructs the complex three-dimensional anatomical structure of the renal pelvis, major calyces, minor calyces, and ureter, providing a high-fidelity training environment for surgical path exploration and instrument manipulation using flexible ureteroscopy and percutaneous nephrolithotomy.

[0112] Figure 16 A flowchart illustrating a training method for a training system for minimally invasive kidney stone surgery according to an embodiment of this application is shown.

[0113] like Figure 16 As shown, the training method of the training system for minimally invasive kidney stone surgery in this embodiment may include operations S1610 to S1650.

[0114] Using the S1610, images of the kidney inside the kidney model are acquired.

[0115] In a specific embodiment, images of the kidney cavity within the kidney model can be acquired using an image acquisition device. This device can be a camera mounted at the tip of a flexible ureteroscope or percutaneous nephroscope. The kidney model may contain stones and a fluid-filled renal pelvis.

[0116] Images of the kidney can also be ultrasound images acquired using ultrasound equipment. Figure 17 An ultrasound image of a kidney model according to an embodiment of this application is shown schematically.

[0117] like Figure 17 As shown, filling a kidney model with water and then sealing the ureter simulates the renal pelvis filling procedure during percutaneous nephrolithotomy. By fixing the kidney model in water and scanning it with an ultrasound probe parallel to the kidney's long axis, clear ultrasound images of the kidney boundaries, renal pelvis, and calyces can be obtained. The liquid environment in the water simulates the imaging effect of ultrasound on the dorsal skin and muscle tissue of the human body after applying coupling gel. A prosthetic skin can be placed at the opening of the hip cavity model, and the entire hip cavity model can be placed in a water environment to perform percutaneous nephrolithotomy training using ultrasound imaging technology.

[0118] While operating the S1620, with surgical instruments inside the kidney model, water pressure data within the renal pelvis are collected.

[0119] In specific embodiments, surgical instruments may include a flexible ureteroscope, a percutaneous nephroscope, a stone retrieval basket, and a puncture needle. Water pressure data within the renal pelvis can be collected using a flexible piezoresistive sensor.

[0120] During operation of S1630, the intrarenal pressure parameters are obtained based on the electrical signal generated from the water pressure data.

[0121] In a specific embodiment, the flexible piezoresistive sensor can transmit electrical signals to a host computer, which can then interpret the electrical signals into intrarenal pressure parameters.

[0122] During operation of S1640, the positional parameters of the surgical instruments within the kidney model are obtained based on the intrarenal image.

[0123] In a specific embodiment, the intrarenal images acquired by the image acquisition device can be used to obtain the positional parameters of the surgical instruments within the kidney model on the display device. These positional parameters may include the spatial positional parameters of the surgical instruments and the stones.

[0124] When operating the S1650, a training task based on target-level minimally invasive kidney stone surgery is performed, displaying real-time images of the kidney, intrarenal pressure parameters, and location parameters, so that the user can manipulate the stones in the kidney model using surgical instruments and evaluate the operation.

[0125] According to embodiments of this application, the training method constructs an immersive training platform covering the entire surgical process and multiple procedures, capable of reproducing the entire surgical procedure from instrument access and navigation to lithotripsy and stone removal. Furthermore, this training method creates objective, quantitative, and multi-dimensional surgical skill evaluation indicators and utilizes an integrated flexible piezoresistive sensor to achieve real-time and accurate monitoring of the key physiological parameter of intrarenal pressure. Combined with positional parameters and other indicators, it provides data support for assessing the safety of the procedure. Combined with visual feedback from intrarenal images, it provides a comprehensive and objective evaluation of the procedure.

[0126] Those skilled in the art will understand that the features described in the various embodiments of this application can be combined and / or combined in various ways, even if such combinations or combinations are not explicitly described in this application. In particular, the features described in the various embodiments of this application can be combined and / or combined in various ways without departing from the spirit and teachings of this application. All such combinations and / or combinations fall within the scope of this application.

[0127] The embodiments of this application have been described above. However, these embodiments are merely illustrative and not intended to limit the scope of this application. Although various embodiments have been described above, this does not mean that the measures in the various embodiments cannot be used advantageously in combination. Without departing from the scope of this application, those skilled in the art can make various substitutions and modifications, all of which should fall within the scope of this application.

Claims

1. A training system for minimally invasive surgery for kidney stones, characterized in that, include: A kidney model with stones and a water-filled renal pelvis inside; An image acquisition device is installed at one end of a surgical instrument and is used to enter the kidney model along with the surgical instrument to acquire images inside the kidney. A flexible piezoresistive sensor is attached to the inner wall of the renal pelvis near the abdomen inside the kidney model. It is used to generate an electrical signal based on the water pressure data inside the renal pelvis when the surgical instruments are inserted into the kidney model. The host computer is used to analyze the electrical signals and obtain intrarenal pressure parameters; A display device is used for training tasks of minimally invasive kidney stone surgery based on target levels. Based on the intrarenal image, the device obtains the position parameters of the surgical instruments within the kidney model and displays the intrarenal pressure parameters and the position parameters in real time, so that the user can use the surgical instruments to operate on the stones and evaluate the operation.

2. The training system according to claim 1, characterized in that, The training system also includes: A bladder model is connected to the ureter of the kidney model; wherein the bladder model is provided with a urethral end for providing an access channel for the surgical instruments during ureteroscopic lithotripsy. A hip cavity model is used to fix the kidney model and the bladder model; wherein, a strip-shaped opening is provided on one side of the waist of the hip cavity model to provide a puncture channel for the surgical instruments during percutaneous nephrolithotomy.

3. The training system according to claim 2, characterized in that, The target level of the training task is determined based on the size, number, and location of the stones in the kidney model.

4. The training system according to claim 3, characterized in that, When the target level is Level 1, the size of the stones in the kidney model is between 5mm and 10mm, the number of stones is between 1 and 2, and the stones are located in the first region of the renal pelvis. The training task for ureteroscopic lithotripsy is based on the stones.

5. The training system according to claim 3, characterized in that, When the target level is Level 2, the size of the stones in the kidney model is between 10mm and 15mm, the number of stones is between 2 and 3, and at least one stone is located in the second region of the renal pelvis. The training task for percutaneous nephrolithotomy is based on the stones.

6. The training system according to claim 3, characterized in that, When the target level is level three, the size of the stones in the kidney model is between 15mm and 20mm, the number of stones is three, and at least one stone is located in the third region of the renal pelvis. The training task for percutaneous nephrolithotomy is based on these stones.

7. The training system according to any one of claims 1 to 6, characterized in that, The training system also includes an oscilloscope connected to the host computer; The oscilloscope is used to display the waveform curve of the intrarenal pressure parameter obtained by the host computer.

8. The training system according to any one of claims 1 to 6, characterized in that, The flexible piezoresistive sensor includes a flexible strain layer, a flexible encapsulation layer, and a flexible substrate layer; The flexible piezoresistive sensor transmits the electrical signal to the host computer via an external circuit board and a data acquisition card.

9. A method for manufacturing a kidney model for a training system of minimally invasive kidney stone surgery according to any one of claims 1 to 8, characterized in that, include: The first silicone material was injected into the renal pelvis casting model, and after curing, the model was demolded to obtain the renal pelvis model. The renal pelvis model is positioned within the renal parenchyma casting model, and a second silicone material is injected into the renal parenchyma casting model; the elastic modulus of the first silicone material is higher than that of the second silicone material. After the second silicone material has cured, the renal pelvis model is separated from the second silicone material to obtain the kidney model.

10. A training method for a training system for minimally invasive kidney stone surgery according to any one of claims 1 to 8, characterized in that, include: Images of the kidney inside a kidney model were acquired, the kidney model containing stones and a renal pelvis filled with water. With surgical instruments inserted into the kidney model, water pressure data within the renal pelvis are collected; Based on the electrical signal generated from the water pressure data, the intrarenal pressure parameters are obtained; Based on the intrarenal image, the positional parameters of the surgical instruments within the kidney model are obtained; The training task for minimally invasive kidney stone surgery based on target levels displays the intrarenal images, intrarenal pressure parameters, and location parameters in real time, so that the user can use the surgical instruments to manipulate the stones in the kidney model and evaluate the manipulation.

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