Ureter safe expansion guide wire system and progressive pressure control method

Abstract

The invention discloses a safe ureter dilatation guide wire system and a progressive pressure control method, and relates to the technical field of medical instruments.The safe ureter dilatation guide wire system comprises a guide wire body and a pressure sensor, the guide wire body comprises a water bag structure and a double-cavity structure which are communicated, the water bag structure is made of an elastic structure, and the double-cavity structure is made of an elastic material; the interior of the water bag structure is used for being filled with expansion liquid and expanding according to the target volume so as to expand the narrow position of the ureter. A guide wire cavity and a liquid injection cavity which are independently arranged are formed in the double-cavity structure, the guide wire cavity and the liquid injection cavity are both communicated with the water bag structure, the guide wire cavity is used for allowing the identification light source to penetrate through, and the liquid injection cavity is used for providing expansion liquid for the water bag structure; the pressure sensor is installed outside the water bag structure so as to detect the pressure of the inner wall tissue of the ureter in real time. According to the technical scheme, the problem that an existing ureter guide wire cannot monitor the deformation state of narrow tissue in real time is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a ureteral safety dilation guidewire system and a progressive pressure control method. Background Art

[0002] In the fields of urology and interventional therapy, ureteral guidewire systems are key tools for managing ureteral strictures, stones, or obstructions. Traditional ureteral surgeries typically require the use of multiple instruments, including a guidewire, dilation balloon, and catheter, in a step-by-step process: first, a hydrophilic guidewire is used to locate the stricture, then a balloon catheter is replaced for dilation, and finally, a working catheter is inserted to complete the procedure.

[0003] Existing guidewire systems for ureteral dilation often rely on the operator's empirical judgment of injection pressure (e.g., preset pressure values ​​or hand feel feedback), and are unable to monitor the actual deformation state of the stenotic tissue during balloon dilation (e.g., strain distribution, elastic modulus changes, etc.). This can lead to under- or over-dilation, especially for complex stenosis or fibrotic lesions. Summary of the Invention

[0004] The main purpose of the present invention is to propose a ureteral safe dilation guidewire system and a progressive pressure control method, aiming to solve the problem that the existing ureteral guidewire cannot monitor the deformation state of the stenotic tissue in real time.

[0005] To achieve the above-mentioned purpose, the present invention proposes a ureteral safety dilation guidewire system, which comprises:

[0006] The guidewire body includes a water bladder structure and a dual-cavity structure that are interconnected. The water bladder structure is made of an elastic structure. The interior of the water bladder structure is used to be filled with an expansion fluid and expand according to a target volume to expand the narrow position of the ureter. The interior of the dual-cavity structure forms an independently arranged guidewire cavity and a liquid injection cavity. Both the guidewire cavity and the liquid injection cavity are connected to the water bladder structure. The guidewire cavity is used to allow the marker light source to pass through, and the liquid injection cavity is used to provide the expansion fluid to the water bladder structure.

[0007] A pressure sensor is installed on the outside of the water bag structure to detect the pressure of the inner wall tissue of the ureter in real time.

[0008] In one embodiment, a plurality of pressure sensors are provided, and the plurality of pressure sensors are evenly spaced along the circumference of the water bag structure.

[0009] In one embodiment, the water bag structure includes an inner layer, a middle layer and an outer layer which are sequentially arranged in a sleeve manner, the guide wire cavity extends to the interior of the inner layer, and the inner layer is an elastic woven mesh, the middle layer is an elastic support layer, and the outer layer is a low-friction coating.

[0010] In one embodiment, the braiding angle of the elastic braided mesh is in the range of 50°-60°; and / or the mesh density of the elastic braided mesh is 120 holes / cm2.

[0011] In one embodiment, the guidewire body further includes a guide structure, which is provided at one end of the water bag structure away from the double-cavity structure, and is made of a flexible material.

[0012] In one embodiment, the guidewire body is further provided with a reinforcing rib, which is provided on the water bag structure and extends along the length direction of the water bag structure.

[0013] In one embodiment, the ureteral safety dilation guidewire system further includes a handle assembly, and the handle assembly is mounted on an end of the double-lumen structure away from the water balloon structure.

[0014] In one embodiment, the handle assembly is provided with a pressure detection interface, and the ureteral safety dilation guidewire system further includes a display device, and the pressure detection interface is communicatively connected to the display device.

[0015] In one embodiment, the handle assembly comprises:

[0016] A handle housing, mounted on the outside of the double-cavity structure;

[0017] a pressure control module, disposed in the handle housing and in communication with the pressure sensor, wherein the pressure detection interface is disposed on the pressure control module; and

[0018] An intelligent control unit is disposed in the handle housing, and the intelligent control unit is communicatively connected to the pressure sensor and the display device.

[0019] In one embodiment, the ureteral safety dilation guidewire system further includes an early warning module, which is mounted on the handle assembly or the display device and is in communication with the pressure sensor.

[0020] The present invention further provides a progressive pressure control method, which is applied to a ureteral safety dilation guidewire system. The ureteral safety dilation guidewire system is the ureteral safety dilation guidewire system as described in any of the above embodiments. The progressive pressure control method comprises:

[0021] Calculating target pressure values ​​corresponding to multiple pressurization stages according to the target diameter of the ureter;

[0022] Injecting expansion fluid into the opening of the injection cavity, the expansion fluid reaches the interior of the water bag structure through the injection cavity, causing the water bag structure to expand to the target pressure value of the corresponding stage and maintain it for 30-60 seconds;

[0023] The number of the pressurization stages is dynamically adjusted according to the stenosis length of the ureter.

[0024] The present invention's guidewire body comprises a water bladder structure and a dual-lumen structure. The water bladder is filled with distending fluid, which expands to a target volume to dilate the ureteral stricture. The dual-lumen structure is equipped with independent guidewire and injection lumens. The guidewire lumen allows the passage of an indicator light source (such as an optical fiber or fluorescent light source), which allows for visual confirmation of the guidewire's current position within the ureter, ensuring that the water bladder structure fully covers the stricture. The injection lumen, on the other hand, allows the passage of distending fluid to the interior of the water bladder structure. This system integrates the guidewire guidance and dilation functions into a single device, eliminating the need for repeated replacement of guidewires and balloon catheters in traditional surgeries. This significantly shortens surgical time and reduces the risk of tissue damage caused by multiple instrument exchanges. Furthermore, a pressure sensor is installed on the exterior of the water bladder structure to measure the contact pressure between the outer wall of the water bladder structure and the inner wall of the ureter in real time. This pressure data can be transmitted to an external device via a signal line within the guidewire lumen or wirelessly, allowing the surgeon to dynamically adjust the dilation force to avoid tissue damage caused by excessive dilation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying any creative work.

[0026] Figure 1 A schematic structural diagram of an embodiment of a ureteral safety dilation guidewire system provided by the present invention;

[0027] Figure 2 A schematic diagram of the external structure of the water bag structure in one embodiment of the ureteral safety dilation guidewire system provided by the present invention;

[0028] Figure 3 A schematic diagram of the internal structure of the water bag structure in another embodiment of the ureteral safety dilation guidewire system provided by the present invention;

[0029] Figure 4 A schematic diagram of the exterior structure of the water sac structure in another embodiment of the ureteral safety dilation guidewire system provided by the present invention;

[0030] Figure 5 A schematic structural diagram of another embodiment of the ureteral safety dilation guidewire system provided by the present invention;

[0031] Figure 6 This is a schematic diagram of the internal structure of the handle assembly in another embodiment of the ureteral safety dilation guidewire system provided by the present invention.

[0032] Description of Figure Numbers:

[0033] 100. Ureteral safe dilation guidewire system; 1. Guidewire body; 11. Water sac structure; 110. Reinforcement ribs; 111. Inner layer; 112. Middle layer; 113. Outer layer; 12. Double-cavity structure; 121. Guidewire cavity; 122. Injection cavity; 13. Guide structure; 2. Pressure sensor; 3. Handle assembly; 31. Handle housing; 32. Pressure control module; 33. Intelligent control unit; 4. Display device; 5. Early warning module; 51. Vibration submodule; 52. Pressure relief submodule; 53. Acousto-optic submodule.

[0034] The purpose, features and advantages of the present invention will be further described with reference to the accompanying drawings and in conjunction with the embodiments. DETAILED DESCRIPTION

[0035] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts shall fall within the scope of protection of the present invention.

[0036] It should be noted that if the embodiments of the present invention involve directional indications (such as up, down, left, right, front, back, etc.), the directional indications are only used to explain the relative position relationship, movement status, etc. between the components under a certain specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0037] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present invention, the descriptions of "first", "second", etc. are only for descriptive purposes and cannot be understood as indicating or suggesting their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features limited to "first" and "second" may explicitly or implicitly include at least one of such features. In addition, if "and / or" or "and / or" appears in the full text, its meaning includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or solutions that satisfy both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0038] Existing guidewire systems for ureteral dilation often rely on the operator's empirical judgment of injection pressure (e.g., preset pressure values ​​or hand feel feedback), and are unable to monitor the actual deformation state of the stenotic tissue during balloon dilation (e.g., strain distribution, elastic modulus changes, etc.). This can lead to under- or over-dilation, especially for complex stenosis or fibrotic lesions.

[0039] The present invention provides a ureteral safety dilation guidewire system.

[0040] See also Figure 1 In one embodiment of the present invention, the ureteral safety dilation guidewire system 100 includes:

[0041] The guidewire body 1 includes a connected water bladder structure 11 and a dual-lumen structure 12. The water bladder structure 11 is made of an elastic structure. The interior of the water bladder structure 11 is used to fill the expansion fluid and expand according to the target volume to expand the narrow part of the ureter. The interior of the dual-lumen structure 12 forms an independently set guidewire cavity 121 and a liquid injection cavity 122. Both the guidewire cavity 121 and the liquid injection cavity 122 are connected to the water bladder structure 11. The guidewire cavity 121 is used to allow the marker light source to pass through, and the liquid injection cavity 122 is used to provide expansion fluid to the water bladder structure 11; and

[0042] The pressure sensor 2 is installed on the outside of the water bag structure 11 to detect the pressure of the inner wall tissue of the ureter in real time.

[0043] In the technical solution of the present invention, the guidewire body 1 includes a water bladder structure 11 and a dual-lumen structure 12. The interior of the water bladder structure 11 is used to fill with distending fluid, causing it to expand according to the target volume to dilate the narrow part of the ureter. The dual-lumen structure 12 is provided with independent guidewire lumens 121 and injection lumens 122. The guidewire lumen 121 is used to allow the passage of an identification light source (such as an optical fiber or fluorescent light source). The identification light source can be used to confirm the current position of the guidewire body 1 inside the ureter through the identification light source, ensuring that the water bladder structure 11 completely covers the narrow area. The interior of the injection lumen 122 is used to allow the passage of distending fluid to deliver distending fluid to the interior of the water bladder structure 11. In other words, this system integrates the guidewire guidance and dilation functions into a single device, avoiding the steps of repeatedly replacing the guidewire and balloon catheter in traditional surgery, significantly shortening the operation time and reducing the risk of tissue damage caused by multiple device exchanges. In addition, a pressure sensor 2 is provided on the outside of the water bag structure 11, which can detect the contact pressure between the outer wall of the water bag structure 11 and the inner wall of the ureter in real time. The pressure data can be transmitted to an external device through a signal line in the guide wire cavity 121 or wirelessly, so that the operator can dynamically adjust the expansion force to avoid tissue damage caused by excessive expansion.

[0044] Specifically, the pressure sensor 2 can be a piezoresistive or capacitive sensor, fixed to the exterior of the water bladder structure 11 using flexible packaging technology. The specific working principle is as follows: the guidewire body 1 is inserted through the urethra, and an identification light source (such as a fluorescent light source) is inserted into the guidewire lumen 121. Under the guidance of an endoscope or imaging device, the water bladder structure 11 is precisely pushed to the narrow section of the ureter. Subsequently, an expansion fluid is injected into the injection lumen 122, and the water bladder structure 11 gradually expands, for example, from a normal outer diameter of 5 French to a maximum outer diameter of 8 French.

[0045] A radial force is applied to the narrowed segment to expand the lumen. During this process, the pressure sensor 2 provides real-time feedback of the inner wall pressure. If the preset threshold (such as the tissue tolerance limit) is exceeded, the system can automatically stop injecting fluid or alarm to avoid over-expansion. After the expansion is completed, the expansion fluid is withdrawn to shrink the water bag structure 11. The double-cavity structure 12 in the guidewire body 1 can continue to serve as a working channel to guide the insertion of subsequent instruments (such as stent catheters), or directly withdraw the system.

[0046] In the embodiments of the present invention, see Figure 2, there are multiple pressure sensors 2, and the multiple pressure sensors 2 are evenly spaced along the periphery of the water bag structure 11. For example, there can be 4-8 pressure sensors 2, and the multiple pressure sensors 2 can be evenly distributed along the circumference of the outer wall of the water bag structure 11, or can be spirally arranged along the long axis direction of the water bag structure 11, so that the pressure distribution of different parts of the ureter can be monitored in real time to avoid local excessive expansion leading to tissue damage (such as perforation or tearing). Optionally, the outer surface of the pressure sensor 2 can be coated with a biocompatible coating (such as polyparaxylene) to avoid direct friction with the tissue. And the signal line of the pressure sensor 2 can be connected to the proximal interface of the external device through the guide wire cavity 121 or an independent microchannel, or wireless transmission can be used.

[0047] In the embodiments of the present invention, see Figure 3 The water bag structure 11 includes an inner layer 111, a middle layer 112 and an outer layer 113 which are sequentially arranged. The guide wire cavity 121 extends to the interior of the inner layer 111. The inner layer 111 is an elastic woven mesh, the middle layer 112 is an elastic support layer, and the outer layer 113 is a low-friction coating. The inner layer 111 is made of an elastic woven mesh, which can be woven from a superelastic material (such as nickel-titanium alloy, polyester or polyethylene). It covers the inner side of the middle layer 112 and is in direct contact with the expansion fluid. It serves as a mechanical restriction layer of the water bag structure 11 and provides the main elastic expansion effect. There is no specific limitation on the pore size of the elastic woven mesh, for example, it can be 40-60 μm; the middle layer 112 can be a silicone or polyester matrix layer, the thickness of the middle layer 112 can be 0.15-0.3 mm, and the bursting pressure is greater than 10 atm. In this way, it can play an elastic support role for the elastic woven mesh from the outside of the inner layer 111, ensuring that it can accommodate a larger volume of water for expansion; the outer layer 113 can be a low-friction coating (such as a friction coefficient of <0.02) such as polyvinyl pyrrolidone, silicone oil lubricating layer or phosphorylcholine, which is in direct contact with the inner wall of the ureter. Its main function is to reduce friction resistance and reduce damage to tissue during insertion and movement of the guide wire.

[0048] In an embodiment of the present invention, the braiding angle of the elastic braided mesh is in the range of 50°-60°, forming a diamond mesh structure, which optimizes the mechanical distribution of the mesh, so that the water bag structure 11 can evenly apply force when expanding, avoiding ureteral damage caused by local stress concentration. That is, the braided mesh is staggered at an angle of 55°±5°, which optimizes the balance between axial flexibility and radial stiffness, can effectively limit its expansion in the axial direction, and ensure uniform expansion only in the radial direction. Optionally, the mesh density on the elastic braided mesh is 120 holes / cm 2 .

[0049] In the embodiments of the present invention, see Figure 1 and Figure 5The guidewire body 1 also includes a guide structure 13, which is arranged at the end of the water bag structure 11 away from the double-cavity structure 12, and the guide structure 13 is made of a flexible material. The guide structure 13 is arranged at the distal end of the water bag and is made of a flexible material (such as silicone or polyurethane). It can conform to the natural curvature of the ureter and reduce the pushing resistance. It is particularly suitable for tortuous or angled narrow sections. In addition, the guide structure 13 can naturally straighten after passing through the narrow section, ensuring that the water bag is centrally positioned, so that the expansion force acts evenly on the narrow wall, avoiding tissue damage caused by eccentric expansion. In addition, the guide structure 13 and the water bag structure 11 are integrated into the same guidewire body 1, avoiding additional replacement of the guidewire or use of steering instruments during surgery.

[0050] In the embodiments of the present invention, see Figure 4 The guidewire body 1 is also equipped with a reinforcing rib 110, located at one end of the water bladder structure 11 near the guide structure 13. Ribs 110 extend along the length of the water bladder structure 11. Ribs 110 can be formed as multiple longitudinally extending ridges to enhance local shear resistance and reduce stress concentration during advancement of the scope. Furthermore, ribs 110 can have an inclined guiding surface, forming a gradually expanding outer periphery to facilitate guidance to the target location within the ureter.

[0051] In the embodiments of the present invention, see Figure 5 The ureteral safe dilation guidewire system 100 also includes a handle assembly 3, which is mounted on the end of the dual-lumen structure 12 away from the water bladder structure 11. The handle assembly 3 can be made of a material such as polycarbonate and feature anti-slip ridges or silicone anti-slip grooves on the surface for easy grip, enabling the operator to perform guidewire pushing, rotation, and injection operations with one hand. The shape of the handle assembly 3 is not specifically limited and can be an arc-shaped grip or a cubical handle structure.

[0052] In the embodiments of the present invention, see Figure 5 The handle assembly 3 is provided with a pressure detection interface. The ureteral safe dilation guidewire system 100 also includes a display device 4, which is in communication with the display device 4. One end of the pressure detection interface is connected to the pressure sensor 2 via a wire, and the other end of the pressure detection interface is connected to the display device 4 via an external wire or wirelessly. This enables real-time digital display of the dilation pressure, allowing the operator to intuitively understand the stress on the ureteral wall and avoid tissue damage caused by excessive dilation.

[0053] In the embodiments of the present invention, see Figure 6 , the handle assembly 3 includes:

[0054] A handle housing 31 is mounted outside the dual-cavity structure 12;

[0055] The pressure control module 32 is disposed in the handle housing 31 and is in communication with the pressure sensor 2 . The pressure detection interface is disposed on the pressure control module 32 ; and

[0056] The intelligent control unit 33 is disposed in the handle housing 31 . The intelligent control unit 33 is communicatively connected to the pressure sensor 2 and the display device 4 .

[0057] Specifically, the handle shell 31 can be made of medical-grade ABS plastic or aluminum alloy. A receiving cavity is formed inside the handle shell 31. Two spaced limit grooves can be provided on the wall of the receiving cavity for respectively fixing the pressure control module 32 and the intelligent control unit 33. The pressure control module 32 can adopt a PID control algorithm, and the pressure detection interface can adopt a standard Luer lock or quick-release connector to facilitate the connection of an external sensor or catheter, thereby achieving stable output of pressure data. Closed-loop feedback control is achieved through real-time communication between the pressure control module 32 and the pressure sensor 2. The main control chip of the intelligent control unit 33 can be an STM32 series MCU or a higher-performance processor to support real-time data processing; the interior of the intelligent control unit 33 can be provided with an installation threshold, for example, the upper limit of strain energy density: 2.5kJ / m 3 Local pressure threshold: 110 kPa; Pressure distribution unevenness threshold: 35%. When the data collected by the intelligent control unit 33 from the pressure sensor 2 exceeds the safety threshold of the above parameters, the alarm module is activated to issue an early warning. The communication interface can be Bluetooth, Wi-Fi, or wired communication (such as USB-C) for connecting to the display device 4 or the host computer.

[0058] The specific working principle is as follows: After the handle assembly 3 is powered on, the intelligent control unit 33 performs a self-check to confirm that the pressure sensor 2 and the pressure control module 32 are working properly. The pressure sensor 2 detects the pressure data in real time and transmits it to the intelligent control unit 33 through the pressure detection interface. After analyzing the data, the intelligent control unit 33 sends an adjustment instruction (such as increasing / decreasing pressure) to the pressure control module 32. The pressure control module 32 performs adjustments (such as adjusting the injection flow or flow rate of the expansion fluid) to stabilize the pressure within the target range. The pressure data is displayed in real time on the display device 4, and the operator can adjust the parameters at any time. If an abnormality is detected (such as a sudden pressure rise or blockage), the system automatically triggers an alarm or protection mechanism (such as stopping the pressure supply).

[0059] In the embodiments of the present invention, see Figure 5 and Figure 6The ureteral safe dilation guidewire system 100 further includes an early warning module 5, which is mounted on the handle assembly 3 or the display device 4 and is in communication with the pressure sensor 2. The early warning module 5 may be an alarm module, a tactile feedback module, or a vibration module. Through real-time communication between the early warning module 5 and the pressure sensor 2, the system can identify abnormal pressure changes (such as catheter blockage and tissue damage risk) in advance and issue an audible and visual alarm or tactile feedback, thereby supporting a multi-level early warning mechanism (such as prompts, emergency alarms, and automatic decompression), significantly improving surgical safety and adapting to scenarios with different risk levels.

[0060] In the embodiments of the present invention, see Figure 6 The early warning module 5 includes a vibration submodule 51, which is installed on the handle assembly 3 and is communicatively connected to the pressure sensor 2. The vibration submodule 51 can be a vibration motor provided on the handle assembly 3, and the interior of the vibration motor can be provided with graded vibrations (such as slight vibrations indicating that the pressure is approaching the threshold, and strong vibrations warning of dangerous pressures) to help doctors quickly judge the risk level. The vibration motor can be a flat ERM (eccentric rotor motor) or LRA (linear resonant motor), and the interior of the handle assembly 3 can be provided with a shock-absorbing bracket, which can be a silicone cushioning pad for mounting the vibration motor. The handle assembly 3 can be provided with heat dissipation holes to prevent the motor from overheating after prolonged operation.

[0061] In the embodiments of the present invention, see Figure 5 The early warning module 5 includes a pressure relief submodule 52, which is mounted on the handle assembly 3 and is in communication with the intelligent control unit 33. The pressure relief submodule 52 can be a micron-level precision pressure relief valve, installed inside the handle assembly 3 or within the proximal end of the injection chamber 122. The pressure relief submodule 52 works in conjunction with the intelligent control unit 33 to intelligently select the degree of pressure relief based on the pressure change trend. In addition, the pressure relief submodule 52 supports a graded pressure relief strategy, with partial pressure relief for minor overshoots and complete pressure relief for severe overshoots.

[0062] In the embodiments of the present invention, see Figure 5 The warning module 5 includes an acousto-photonic submodule 53, which is mounted on the display device 4 and is in communication with the intelligent control unit 33. The acousto-photonic submodule 53 is mounted on the display device 4 and may include an LED array and a light guide structure. The LED array may use RGB three-color LEDs arranged in a 360° ring. For example, red light (620nm) represents an emergency warning; green light (525nm) represents a normal state; and blue light (470nm) represents a special prompt. The light guide structure is a side-entry light guide plate provided inside the display device 4. Optionally, a polarizing film is embedded in the light guide plate to eliminate screen reflections.

[0063] The present invention further provides a progressive pressure control method, which is applied to a ureteral safe dilation guidewire system 100. The specific structure of the ureteral safe dilation guidewire system 100 is similar to the above embodiment. The progressive pressure control method includes:

[0064] Calculating target pressure values ​​corresponding to multiple pressurization stages according to the target diameter of the ureter;

[0065] An expansion fluid is injected into the opening of the injection cavity 122. The expansion fluid reaches the interior of the water bag structure 11 through the injection cavity 122, causing the water bag structure 11 to expand to the target pressure value of the corresponding stage and maintain it for 30-60 seconds; wherein, the number of pressurization stages is dynamically adjusted according to the stenosis length of the ureter.

[0066] Specifically, when dilating, first place the guidewire body 1 inside the ureter, and with the assistance of a ureteroscope, place the front end of the guidewire body 1 through the urethra into the distal end of the ureteral stricture; confirm the position of the guidewire body 1 through the fluorescent perspective in the guidewire cavity 121 to ensure that the water bag structure 11 completely covers the stricture area. According to the stricture length of the ureter, multiple pressurization stages are divided. For example: when the stricture length is ≤2cm, the default is 4-stage progressive expansion (pressure increase in each stage ≤0.3atm); when the stricture length is >2cm, it automatically switches to the 6-stage mode (pressure increase in each stage ≤0.5atm), thereby achieving "step-by-step" progressive expansion. The detailed steps are:

[0067] Phase 1 - Water Injection Expansion:

[0068] a. Inject distending fluid (e.g., saline) to the initial pressure value (20% of the preset target pressure value, e.g., if the target is 4 atm, the initial pressure is 0.8 atm);

[0069] b. Maintain for 30 seconds to relax the ureteral tissue stress while the intelligent control unit 33 calculates the strain energy density;

[0070] Stage 2 - Dynamic Pressure Regulation:

[0071] a. The pressure increase in each stage is ≤0.5atm, and the system automatically determines the pressure value of the next stage;

[0072] b. If the real-time strain energy density is less than 2.0 kJ / m 3 , increase by 0.5atm;

[0073] c. If 2.0kJ / m 3 ≤Strain energy density<2.5kJ / m 3 , the pressure increase is reduced to 0.3atm;

[0074] Phase 3 - Multimodal Security Monitoring:

[0075] a. Real-time pressure heat map: displays the pressure distribution in four areas on the surface of the water bag;

[0076] b. Level 3 warning response:

[0077] Level 1 warning (local pressure > 110 kPa): the vibration submodule 51 (50 Hz) prompts the operator to suspend propulsion;

[0078] Level 2 warning (strain rate > 0.8s-1): the pressure relief submodule 52 is activated and the pressure drops to a safe value (current pressure - 0.3atm);

[0079] Level 3 warning (pressure distribution unevenness>35%): the system locks the expansion function and triggers the acousto-photon module 53 to alarm (manual reset is required).

[0080] Among the parameters of the above-mentioned installation threshold, the pressure can be directly detected and output by the pressure sensor 2, the strain rate can be indirectly calculated from the data collected by the pressure sensor 2; and the pressure distribution unevenness can be calculated by calculating the pressure between multiple pressure sensors 2.

[0081] Phase 4 - Expansion Completion and Effect Evaluation:

[0082] a. Expansion termination conditions: reaching the preset target diameter (such as F18) and the strain energy density is stable <2.5kJ / m 3 Lasts 60 seconds;

[0083] b. Safety report generation (intelligent control unit 33 outputs expansion safety assessment report, pressure-time curve, strain energy density distribution map);

[0084] c. Remove the guidewire body 1: Slowly release the pressure to 0 atm, and confirm that the elastic braided mesh has returned to its original shape before withdrawing it from the ureter.

[0085] The above description is merely an exemplary embodiment of the present invention and does not limit the scope of protection of the present invention. Any equivalent structural transformation made by using the contents of the present invention description and drawings under the technical concept of the present invention, or directly / indirectly applied in other related technical fields, is included in the scope of protection of the present invention.

Claims

1. A ureteral safety dilation guidewire system, characterized in that: The ureteral safety dilation guidewire system comprises: The guidewire body includes a water bladder structure and a dual-cavity structure that are interconnected. The water bladder structure is made of an elastic structure. The interior of the water bladder structure is used to be filled with an expansion fluid and expand according to a target volume to expand the narrow position of the ureter. The interior of the dual-cavity structure forms an independently arranged guidewire cavity and a liquid injection cavity. Both the guidewire cavity and the liquid injection cavity are connected to the water bladder structure. The guidewire cavity is used to allow the marker light source to pass through, and the liquid injection cavity is used to provide the expansion fluid to the water bladder structure. A pressure sensor is installed on the outside of the water bag structure to detect the pressure of the inner wall tissue of the ureter in real time.

2. The ureteral safety dilation guidewire system according to claim 1, characterized in that: There are multiple pressure sensors, and the multiple pressure sensors are evenly spaced along the periphery of the water bag structure.

3. The ureteral safety dilation guidewire system according to claim 1, characterized in that: The water bag structure includes an inner layer, a middle layer and an outer layer which are sequentially sleeved, the guide wire cavity extends to the interior of the inner layer, and the inner layer is an elastic woven mesh, the middle layer is an elastic support layer, and the outer layer is a low-friction coating.

4. The ureteral safety dilation guidewire system according to claim 3, characterized in that: The braiding angle of the elastic braided mesh is in the range of 50°-60°; and / or the mesh density of the elastic braided mesh is 120 holes / cm2.

5. The ureteral safety dilation guidewire system according to claim 1, characterized in that: The guidewire body further includes a guide structure, which is provided at one end of the water bag structure away from the double-lumen structure, and is made of a flexible material; and / or, The guide wire body is further provided with a reinforcing rib, which is arranged on the water bag structure and extends along the length direction of the water bag structure.

6. The ureteral safety dilation guidewire system according to claim 1, characterized in that: The ureteral safety dilation guidewire system further includes a handle assembly, which is mounted on one end of the double-lumen structure away from the water bag structure.

7. The ureteral safety dilation guidewire system according to claim 6, characterized in that: The handle assembly is provided with a pressure detection interface, and the ureteral safety dilation guidewire system further includes a display device, and the pressure detection interface is communicatively connected to the display device.

8. The ureteral safety dilation guidewire system according to claim 7, characterized in that: The handle assembly comprises: A handle housing, mounted on the outside of the double-cavity structure; a pressure control module, disposed in the handle housing and in communication with the pressure sensor, wherein the pressure detection interface is disposed on the pressure control module; and An intelligent control unit is disposed in the handle housing, and the intelligent control unit is communicatively connected to the pressure sensor and the display device.

9. The ureteral safety dilation guidewire system according to claim 8, characterized in that: The ureteral safety dilation guidewire system further includes an early warning module, which is mounted on the handle assembly or the display device and is in communication with the pressure sensor.

10. A progressive pressure control method, applied to a ureteral safety dilation guidewire system, characterized in that: The ureteral safety dilation guidewire system is the ureteral safety dilation guidewire system according to any one of claims 1 to 9, and the progressive pressure control method comprises: Calculating target pressure values ​​corresponding to multiple pressurization stages according to the target diameter of the ureter; Injecting expansion fluid into the opening of the injection cavity, the expansion fluid reaches the interior of the water bag structure through the injection cavity, causing the water bag structure to expand to the target pressure value of the corresponding stage and maintain it for 30-60 seconds; The number of the pressurization stages is dynamically adjusted according to the stenosis length of the ureter.

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