Urine leakage prevention catheter with radial adjustable function

Abstract

The invention relates to the technical field of catheter instruments, in particular to a urine leakage prevention catheter with a radial adjustable function, which comprises a catheter front end and a catheter functional part, and a balloon fixer is mounted at the catheter front end; an annular assembly groove is formed in the circumferential outer wall of the ureter functional part and located behind the balloon fixator, a fluid driving type air bag is fixedly connected to the inner annular wall of the assembly groove, a second pipeline is independently installed between the interior and the tail of the ureter functional part, and the second pipeline penetrates out of the tail of the ureter functional part and is connected with a connecting pipe; the outer wall of the fluid-driven air bag expands in the radial direction of the ureter function part when the fluid-driven air bag is pressed; a sensing structure used for urine leakage monitoring is designed on the outer wall, located behind the fluid driving type air bag, of the ureter functional part. Personalized low-pressure sealing is achieved through the fluid driving type air bag, a memory alloy driving horn-shaped structure is matched with a special urethra structure, urine leakage is monitored in real time, and a drainage hole is optimized to prevent blockage.

Description

Technical Field

[0001] This invention relates to the technical field of urinary catheter devices, specifically a leak-proof urinary catheter with radially adjustable function. Background Technology

[0002] The Freund's catheter, which achieves indwelling fixation through inflated bladder balloon, is widely used in clinical practice. However, for elderly patients requiring long-term indwelling catheterization, especially those with weakened urethral sphincter function, this traditional structure has significant drawbacks. First, the balloon is fixed behind the bladder neck, making it difficult to effectively compress and seal the physiological bladder neck-urethral junction (i.e., the internal sphincter area), leading to easy leakage of urine from around the balloon into the urethra. Second, the fixed size of the catheter and its balloon cannot adapt to the vastly different urethral anatomy and sphincter function of different patients, especially elderly patients; the uniform size results in poor sealing. To barely prevent leakage, a high balloon pressure is often required, and long-term compression can easily lead to complications such as ischemia, inflammation, and even necrosis of the bladder neck and urethral mucosa.

[0003] In addition, while some modified devices using multiple airbags or special configurations have some effect, their complex structure and high cost make them unsuitable for widespread clinical application, especially in primary healthcare institutions.

[0004] Therefore, there is an urgent need for a leak-proof urinary catheter that is simple in structure, customizable, and can achieve effective sealing under low pressure. Summary of the Invention

[0005] This invention provides a leak-proof urinary catheter with radially adjustable function, which features personalized low-pressure sealing through a fluid-driven balloon, a shape memory alloy-driven horn-shaped structure adapted to urethral anatomy, real-time monitoring of urinary leakage, and optimized drainage hole to prevent blockage.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A leak-proof urinary catheter with radially adjustable function, comprising:

[0008] The urinary catheter includes a distal end and a functional section. A balloon fixator is installed on the distal end of the urinary catheter. An annular mounting groove is formed on the circumferential outer wall of the functional section behind the balloon fixator. A fluid-driven balloon is fixedly connected to the inner annular wall of the mounting groove. A second pipe is independently installed from the inside of the functional section to its tail end. The second pipe extends out of the tail end of the functional section and is connected to a connecting pipe. When the fluid-driven balloon is compressed, its outer wall expands radially along the functional section. A sensing structure for urine leakage monitoring is designed on the outer wall of the functional section behind the fluid-driven balloon.

[0009] Optionally, the sensing structure includes multiple sensing units. A detection groove is formed on the urethral functional part. The sensing unit is integrated into the detection groove on the outer wall of the urethral functional part by a biocompatible flexible adhesive and is located on the side of the fluid-driven balloon near the urethral orifice. A micro-groove is engraved on the outer wall of the urethral functional part, and the signal lead of the sensing unit is embedded in the micro-groove and covered with an elastomer material of the same material as the tube body, so that the outer surface of the urethral functional part remains smooth and continuous.

[0010] Optionally, the surface of the sensing unit is sequentially covered with an electrical passivation layer, and the outer wall of the detection groove is covered with a porous hydrophobic and moisture-permeable protective membrane. The pore size of the porous hydrophobic and moisture-permeable protective membrane allows water vapor to pass through but blocks large molecules in the urine. The tail end of the urinary catheter functional section is encapsulated with a signal processing circuit, a wireless transmission module, and a power supply that are electrically connected to the sensing unit.

[0011] Optionally, the sensing unit includes a pair of interdigitated electrodes and a flexible polyimide film. The interdigitated electrodes are attached to the flexible polyimide film by sputtering, electroplating or photolithography. The comb electrodes of the two interdigitated electrodes are staggered and form a micro-spacing structure.

[0012] Optionally, a reaction chamber is formed on the circumferential outer wall of the urethral functional part located between the fluid-driven balloon and the balloon fixator. An electric heating ring seat is fixedly installed inside the reaction chamber, and a deformable metal actuator is fixedly installed on the electric heating ring seat. A silicone film for surrounding the opening of the reaction chamber is installed on the outer wall of the urethral functional part. The silicone film can deform under external force. The other end of the deformable metal actuator abuts against the silicone film. The deformable metal actuator can undergo a preset deformation when heated to drive the silicone film to form a trumpet shape, so that the trumpet-shaped silicone film applies pressure to seal the tapered urethra at the internal sphincter, which is wider inside and narrower outside.

[0013] Optionally, the tail end of the urinary catheter functional section is equipped with an electrical terminal, which can be associated with an external power supply device. A micro-circuit is designed between the electrical terminal and the heating ring seat, and the heating ring seat can generate heat when powered.

[0014] Optionally, the deformation metal actuator is made of shape memory alloy, the deformation metal actuator is a medical nickel-titanium alloy, and its austenitic phase transformation end temperature is higher than the human body temperature and lower than 45 degrees Celsius. The deformation metal actuator can be a mesh sleeve design.

[0015] Optionally, in the non-inflated state, the fluid-driven airbag is completely housed within the annular assembly groove, and the outer wall of the fluid-driven airbag does not extend beyond the outer wall of the ureteral functional portion.

[0016] Optionally, the balloon fixator includes a first conduit located at the front end of the urinary catheter and inside the functional part of the urinary catheter. The first conduit extends out of the tail end of the functional part of the urinary catheter and can be connected to an air source. A functional balloon is installed outside the front end of the urinary catheter. The functional balloon does not interfere with the insertion process of the front end of the urinary catheter and the functional part of the urinary catheter when it is in a contracted state. The first conduit is connected to the functional balloon. An increase in air pressure inside the functional balloon will cause it to deform and expand.

[0017] Optionally, a drainage hole is also provided at the front end of the urinary catheter. The drainage hole communicates with the interior of the front end of the urinary catheter, and the diameter of the drainage hole gradually decreases from the outside to the inside, and the cross-section of the hole is a rounded rectangle.

[0018] This invention provides a leak-proof urinary catheter with radially adjustable function, which has the following advantages compared to the prior art:

[0019] I. The structure of the fluid-driven balloon, the annular mounting groove, and the second conduit, combined with the design of the fluid-driven balloon within the annular mounting groove of the urethral functional section and connected to the tail connector via an independent second conduit, creates a radial adjustment system completely independent of the fixed balloon. Medical staff can inject or withdraw a small amount of saline solution into the fluid-driven balloon via the connector through an external device to precisely control its radial expansion size. Once the balloon is displaced and positioned at the location of the internal sphincter in the urethra, its expansion can completely fill the lumen of that segment of the urethra. This allows the balloon to perfectly adapt to the individualized anatomical differences of different patients, especially those with benign prostatic hyperplasia or sphincter relaxation, achieving a seal by precisely matching the pressure of the urethral diameter. This effectively blocks the leakage path of urine along the balloon's periphery. Compared to traditional balloons that blindly expand under high pressure to prevent leakage, this structure achieves a reliable seal with lower, personalized contact pressure, significantly reducing the risk of complications such as urethral mucosal ischemia, erosion, or even necrosis caused by long-term high-pressure compression.

[0020] II. The combination of capacitive sensing unit, micro-grooves, porous hydrophobic and moisture-permeable protective film and tail processing circuit: In the detection tank, a capacitive sensing unit composed of interdigitated electrodes and flexible polyimide film is integrated by a flexible adhesive. Its signal leads are embedded in the micro-grooves of the tube wall and covered by an elastomer to ensure the smoothness of the tube wall. The surface of the sensing unit is successively covered with an electrical passivation layer and an outer porous hydrophobic and moisture-permeable protective film. The nanoscale pore size of the protective film constitutes a selective barrier: allowing water vapor to pass freely to trigger changes in sensor capacitance, while effectively blocking large molecular pollutants such as proteins and salt crystals in urine, preventing the sensor from "poisoning" and failing.

[0021] III. The structural coordination of the deformable metal actuator, the heating ring seat, the reaction chamber, and the silicone membrane: Addressing the physiological conicity of the urethra in the internal sphincter region, which is "wider inside and narrower outside," this design incorporates an active sealing structure driven by a deformable metal actuator in front of the fluid-driven balloon. The deformable metal actuator (fixed to the heating ring seat within the reaction chamber) undergoes a pre-set radial expansion deformation after heating, pushing the silicone membrane outwards to form a "trumpet shape" that is narrower in the front and wider in the back. This unique shape perfectly matches the conical space at the internal sphincter, achieving surface contact sealing. Compared to the line contact of a cylindrical balloon, this provides a larger sealing area and more uniform pressure distribution, achieving a "trumpet-shaped" active seal that dynamically adapts to the anatomical morphology of the urethra, providing a second layer of enhanced sealing protection under complex pathological conditions.

[0022] Fourth, the rounded rectangular drainage hole structure with a wider outer corner and a narrower inner corner, through its unique geometric design, achieves anti-blockage and high flow characteristics of the drainage channel, ensuring continuous and unobstructed urine drainage during long-term indwelling. The "wide outer" entrance increases the urine collection area, making it easier to capture urine, especially when the patient is lying flat and the urine flow is slow. Its four inner corners form natural mechanical barrier points. When the bladder mucosa adheres to the orifice or tissue fragments due to negative pressure, it is difficult to form a complete seal with all the corners at the same time. It always retains a small drainage gap at the corners, making the flow line of urine more gentle. It effectively disperses the local negative pressure peak near the orifice, significantly reduces the "sucking" effect on the bladder mucosa, and reduces the possibility of mucosal adhesion, damage, and even bleeding. Attached Figure Description

[0023] Figure 1 This is a three-dimensional structural diagram of the leak-proof urinary catheter of the present invention;

[0024] Figure 2 This is a three-dimensional structural diagram of the ureter tip and ureter functional part in this invention;

[0025] Figure 3 For the present invention Figure 2 A diagram showing the view from the right.

[0026] Figure 4 For the present invention along Figure 3 A schematic diagram of the cross-section at point AA.

[0027] Figure 5 For the present invention Figure 4 Enlarged view of the structure at point B;

[0028] Figure 6 This is a partial structural diagram of the sensing structure in this invention;

[0029] Figure 7 In this invention Figure 2A schematic diagram of the internal cross-sectional structure.

[0030] In the diagram: 1. Urinary catheter tip; 2. Urinary catheter functional section; 3. Drainage hole; 4. Functional balloon; 5. Fluid-driven balloon; 6. Silicone membrane; 7. Porous hydrophobic and breathable protective membrane; 8. Deformation metal actuator; 9. Heating ring seat; 11. Reaction chamber; 12. First conduit; 13. Second conduit; 14. Interdigital electrode; 15. Detection slot; 16. Connecting tube; 17. Electrical terminal. Detailed Implementation

[0031] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Please see Figures 1 to 7 This invention provides a technical solution: a leak-proof urinary catheter with radially adjustable function, comprising:

[0033] The urinary catheter consists of a distal end 1 and a functional section 2. A balloon fixator is installed on the distal end 1. An annular mounting groove is provided on the circumferential outer wall of the functional section 2 behind the balloon fixator. A fluid-driven balloon 5 is fixedly connected to the inner annular wall of the mounting groove. A second pipe 13 is independently installed from the inside of the functional section 2 to the tail end. The second pipe 13 extends out of the tail end of the functional section 2 and is connected to a connecting pipe 16. When the fluid-driven balloon 5 is compressed, its outer wall expands radially along the functional section 2. A sensing structure for urine leakage monitoring is designed on the outer wall of the functional section 2 behind the fluid-driven balloon 5.

[0034] In existing technologies, patients with bladder neck contracture, benign prostatic hyperplasia, or urethral sphincter relaxation cannot accurately compress the balloon at the physiological bladder neck-urethral junction, causing urine to easily leak back into the urethra from around the balloon and overflow. To reduce leakage and improve sealing, this invention designs a limiting sealing structure behind the balloon fixator. When the fluid-driven balloon 5 moves to a preset position in the urethra, namely the urethra of the internal sphincter and the urethra of the prostate, the radial expansion of the fluid-driven balloon 5 can inflate the urethra at the preset position, thereby blocking the urethra at the preset position and preventing leakage.

[0035] Among them, the fluid-driven airbag 5 and its second pipe 13 constitute a radially adjustable sealing device.

[0036] In a preferred embodiment, the sensing structure includes multiple sensing units. A detection groove 15 is formed on the urethral functional section 2. The sensing units are integrated into the detection groove 15 on the outer wall of the urethral functional section 2 using a biocompatible flexible adhesive, and are located on the side of the fluid-driven balloon 5 near the urethral orifice. Microgrooves are etched into the outer wall of the urethral functional section 2, and the signal leads of the sensing units are embedded in these microgrooves and covered with an elastomer material of the same type as the tube body, ensuring a smooth and continuous outer surface of the urethral functional section 2. Please refer to [link to previous text]. Figure 2 and Figure 6 In this embodiment, to achieve direct and in-situ monitoring of urinary leakage, firstly, by precisely positioning and integrating the sensing unit onto the outer wall of the radially adjustable sealing device near the urethral orifice, source monitoring of urinary leakage events is achieved. The sensing unit is firmly bonded to the silicone tube body with a biocompatible flexible adhesive, ensuring that it can closely conform to the urethral environment without affecting the overall flexibility and biocompatibility of the catheter. This positioning design ensures that if the seal fails, urine will first soak into the sensing area, thereby triggering an immediate response. Secondly, by embedding the signal lead of the sensing unit in a pre-processed micro-groove in the tube wall and covering and filling it with the same elastomer material as the tube body, the electrical connection and mechanical reliability are unified. This effectively avoids the risk of tissue scratching or bacterial colonization that may be caused by exposed leads, while ensuring the smooth continuity of the outer surface of the catheter, maintaining patient comfort and safety during insertion and indwelling.

[0037] Furthermore, the surface of the sensing unit is sequentially covered with an electrical passivation layer, and the outer wall of the detection tank 15 is covered with a porous hydrophobic and moisture-permeable protective membrane 7. The pore size of the porous hydrophobic and moisture-permeable protective membrane 7 allows water vapor to pass through but blocks large molecules in the urine. The tail of the urinary catheter functional part 2 encapsulates a signal processing circuit, a wireless transmission module, and a power supply that are electrically connected to the sensing unit. By sequentially constructing an electrical passivation layer and a porous hydrophobic and moisture-permeable protective membrane 7 on the surface of the sensing unit, long-term stable operation in harsh bodily fluid environments is achieved. The electrical passivation layer, such as silicon nitride, provides the necessary electrical insulation and basic protection for the sensing unit. The outer porous hydrophobic and moisture-permeable protective membrane 7 constitutes a selective barrier. Its nanoscale pore size allows water vapor to pass through freely to ensure sensing sensitivity, while effectively blocking large molecular contaminants such as proteins, crystalline salts, and bacteria in the urine, preventing the sensor from failing due to "biological fouling." This multi-layered protective structure significantly improves the in-vivo reliability, service life, and monitoring accuracy of the sensor.

[0038] Furthermore, the sensing unit includes a pair of interdigitated electrodes 14 and a flexible polyimide film. The interdigitated electrodes 14 are attached to the flexible polyimide film by sputtering, electroplating, or photolithography. The comb-shaped electrodes of the two interdigitated electrodes 14 are staggered and form a micro-spacing structure. Please refer to [link to relevant documentation]. Figure 6The detailed enlarged image shows that, in this embodiment, by designing a precise micro-spacing structure between the interdigital electrodes 14, the sensing unit achieves extremely high sensitivity to changes in the surface dielectric constant. When the ambient humidity changes, the water molecules adsorbed by the sensitive film significantly alter the dielectric properties of the electric field between the electrodes. The micro-spacing design allows this minute change to be sensitively captured and converted into a measurable capacitance signal, thereby achieving a rapid and accurate response to urine wetting. Furthermore, by using a flexible polyimide film as the substrate, mechanical compatibility and biocompatibility between the sensor and the catheter body are achieved. This flexible substrate can bend and deform along with the catheter without affecting the integrity and electrical performance of the electrodes, ensuring long-term reliable operation of the sensor during insertion and indwelling.

[0039] In a preferred embodiment, a reaction chamber 11 is formed on the circumferential outer wall of the urethral functional section 2 located between the fluid-driven balloon 5 and the balloon fixator. An electric heating ring seat 9 is fixedly installed inside the reaction chamber 11, and a deformable metal actuator 8 is fixedly installed on the electric heating ring seat 9. A silicone film 6 is installed on the outer wall of the urethral functional section 2 to surround the opening of the reaction chamber 11. The silicone film 6 can deform under external force. The other end of the deformable metal actuator 8 abuts against the silicone film 6. When heated, the deformable metal actuator 8 can undergo a preset deformation to drive the silicone film 6 into a trumpet shape, so that the trumpet-shaped silicone film 6 applies pressure to seal the tapered urethra (wider inside and narrower outside) at the internal sphincter. (See also...) Figure 4 and Figure 5 In this embodiment, by designing a specific deformation mode for the heat-deformable element, the deformable metal actuator 8, the porous hydrophobic and breathable protective membrane 7 is driven to expand, forming a "trumpet-shaped" sealing surface that matches the conical anatomical structure of the human urethral sphincter, which is wider inside and narrower outside. This shape can achieve a larger area and more uniform contact with the urethral wall, realizing a precise shape-adaptive seal for the urethral sphincter area. It can achieve a more reliable fluid seal with lower local pressure, effectively preventing urinary leakage and significantly reducing the risk of pressure damage to sensitive mucosal tissues. The section of the deformed silicone film 6 near the fluid-driven balloon 5 is narrow.

[0040] Furthermore, the tail end of the urinary catheter functional section 2 is equipped with an electrical terminal 17, which can be associated with a power supply device. A micro-circuit is designed between the electrical terminal 17 and the heating ring seat 9. When the heating ring seat 9 is powered, it can generate heat. The heating ring seat 9 can transfer the heat to the deformation metal actuator 8, so that the deformation metal actuator 8 can be deformed by heat.

[0041] Furthermore, the deformation metal actuator 8 is made of shape memory alloy, specifically medical-grade nickel-titanium alloy, and its austenitic phase transformation end temperature is higher than human body temperature but lower than 45 degrees Celsius. The deformation metal actuator 8 can be a mesh sleeve design. In this embodiment, by limiting the deformation metal actuator 8 to medical-grade nickel-titanium alloy, excellent biocompatibility, long-term in vivo stability, and reliable mechanical properties of the actuator are achieved. Furthermore, by setting the austenitic phase transformation end temperature of the deformation metal actuator 8 within a precise range higher than human body temperature but lower than 45 degrees Celsius, a safe and controllable electrothermal drive logic is achieved. This temperature setting ensures that the element remains stable at normal body temperature and does not undergo unexpected deformation. When a safe current is applied externally to heat it to this phase transformation temperature range, the element quickly and reversibly recovers its preset shape, thereby providing a precise and reliable driving force for the sealing action.

[0042] Furthermore, by designing the deformable metal actuator 8 as a mesh sleeve structure, uniform distribution and efficient transmission of driving force are achieved. The mesh sleeve can fit tightly into the accommodating cavity. When it is heated and contracts or expands, it can apply pressure evenly to the deformable sealing membrane in the circumferential direction, driving it to form a "trumpet-shaped" sealing surface that matches the anatomical structure of the urethra. This design not only improves the driving efficiency but also ensures the uniformity of the sealing pressure, avoiding excessive local pressure. It effectively prevents leakage while maximizing the protection of urethral tissue.

[0043] Medical nickel-titanium alloys have been widely proven to be suitable for long-term implantation environments. The dense oxide layer formed on its surface can effectively prevent corrosion and ion release, meeting the stringent safety standards for medical devices.

[0044] Based on the above embodiments, further, in the non-inflated state, the fluid-driven balloon 5 is completely housed in the annular assembly groove, and the outer wall of the fluid-driven balloon 5 does not exceed the outer wall of the urinary catheter functional part 2, ensuring the integrity and smoothness of the entire catheter, so that it can smoothly pass through the urethra of each tissue in sequence, reducing discomfort and damage.

[0045] Furthermore, the balloon fixator includes a first conduit 12 located inside the ureter tip 1 and the ureter functional section 2. The first conduit 12 extends out of the tail of the ureter functional section 2 and can be connected to an air source. A functional balloon 4 is installed outside the ureter tip 1. When the functional balloon 4 is in a contracted state, it will not interfere with the insertion process of the ureter tip 1 and the ureter functional section 2. The first conduit 12 is connected to the functional balloon 4. The increase in air pressure inside the functional balloon 4 will cause it to deform and expand.

[0046] Furthermore, a drainage hole 3 is provided on the distal end 1 of the urinary catheter. The drainage hole 3 communicates with the interior of the distal end 1 of the urinary catheter, and the diameter of the drainage hole 3 gradually decreases from the outside to the inside, with a rounded rectangular cross-section. In existing technology, traditional circular holes are prone to forming a "complete seal" when the bladder wall or mucosa adheres to the hole opening due to negative pressure or changes in body position, leading to a momentary interruption of drainage. Detached tissue fragments, such as necrotic epithelial cells, are also prone to getting stuck at the edge of the circular hole. However, the four inner corners of the square hole provide natural "mechanical barrier points," making it easier to prevent the bladder mucosa from adhering to the hole. It is difficult to perfectly fit all four right-angled sides at the same time, and tiny drainage gaps will always be left at the corners. This ensures continuous drainage and makes it more difficult for tissue fragments to completely block the square orifice with sharp corners. This greatly reduces the risk of poor drainage and increased bladder pressure due to blockage. When a traditional round orifice is used for drainage, the edge of the orifice is prone to "sucking" on the soft bladder mucosa, causing the mucosa to be sucked in or even damaged. The design of being wider on the outside and narrower on the inside makes the flow of urine smoother when it enters, which helps to disperse and reduce the local negative pressure peak near the orifice, thereby reducing the adhesion to the mucosa.

[0047] By utilizing the combination of the above structures, a personalized low-pressure seal is achieved. The shape memory alloy drives the horn-shaped structure to adapt to the urethral anatomy, and the sensing structure monitors urine leakage in real time, while optimizing the drainage hole to prevent blockage.

[0048] The standard parts used in this embodiment can be purchased directly from the market, and the non-standard structural parts described in the specification and drawings can also be processed without any doubt based on existing technical common sense. At the same time, the connection methods of each component adopt mature conventional methods in the existing technology, and the machinery, parts and equipment all adopt conventional models in the existing technology, so they will not be described in detail here.

[0049] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A leak-proof urinary catheter with radially adjustable function, characterized in that: include: The urinary catheter tip (1) and the urinary catheter functional part (2) are provided with a balloon fixator installed on the urinary catheter tip (1); An annular mounting groove is provided on the circumferential outer wall of the urinary catheter functional part (2) located behind the balloon fixator. A fluid-driven balloon (5) is fixedly connected to the inner annular wall of the mounting groove. A second pipe (13) is independently installed between the inside of the urinary catheter functional part (2) and the tail. The second pipe (13) passes through the tail of the urinary catheter functional part (2) and is connected to a connecting pipe (16). When the fluid-driven balloon (5) is compressed, its outer wall will expand radially along the urinary catheter functional part (2). The outer wall of the ureteral functional section (2) located behind the fluid-driven balloon (5) is designed with a sensing structure for urine leakage monitoring.

2. The leak-proof catheter with radially adjustable function according to claim 1, characterized in that: The sensing structure includes multiple sensing units. A detection groove (15) is provided on the urethral functional part (2). The sensing unit is integrated into the detection groove (15) on the outer wall of the urethral functional part (2) by a biocompatible flexible adhesive and is located on the side of the fluid-driven balloon (5) near the urethral opening. A micro-groove is engraved on the outer wall of the urethral functional part (2), and the signal lead of the sensing unit is embedded in the micro-groove and covered with an elastomer material of the same material as the tube body, so that the outer surface of the urethral functional part (2) remains smooth and continuous.

3. The leak-proof catheter with radially adjustable function according to claim 2, characterized in that: The surface of the sensing unit is sequentially covered with an electrical passivation layer, and the outer wall of the detection groove (15) is covered with a porous hydrophobic and moisture-permeable protective film (7). The pore size of the porous hydrophobic and moisture-permeable protective film (7) allows water vapor to pass through but blocks large molecules in the urine. The tail of the urinary catheter functional part (2) is encapsulated with a signal processing circuit, a wireless transmission module and a power supply that are electrically connected to the sensing unit.

4. The leak-proof catheter with radially adjustable function according to claim 2, characterized in that: The sensing unit includes a pair of interdigitated electrodes (14) and a flexible polyimide film. The interdigitated electrodes (14) are attached to the flexible polyimide film by sputtering, electroplating or photolithography. The comb electrodes of the two interdigitated electrodes (14) are staggered and form a micro-spacing structure.

5. The leak-proof catheter with radially adjustable function according to claim 1, characterized in that: A reaction chamber (11) is provided on the circumferential outer wall of the urethral functional part (2) located between the fluid-driven balloon (5) and the balloon fixator. An electric heating ring seat (9) is fixedly installed inside the reaction chamber (11). A deformable metal actuator (8) is fixedly installed on the electric heating ring seat (9). A silicone film (6) for surrounding the opening of the reaction chamber (11) is installed on the outer wall of the urethral functional part (2). The silicone film (6) can deform under external force. The other end of the deformable metal actuator (8) abuts against the silicone film (6). The deformable metal actuator (8) can undergo a preset deformation when heated to drive the silicone film (6) to form a trumpet shape, so that the trumpet-shaped silicone film (6) applies pressure to seal the tapered urethra at the internal sphincter, which is wider inside and narrower outside.

6. The leak-proof catheter with radially adjustable function according to claim 5, characterized in that: The end of the urinary catheter functional part (2) is equipped with an electrical terminal (17), which can be associated with an external power supply device. A micro-circuit is designed between the electrical terminal (17) and the heating ring seat (9), and the heating ring seat (9) can generate heat when connected to electricity.

7. The leak-proof catheter with radially adjustable function according to claim 6, characterized in that: The deformation metal actuator (8) is made of shape memory alloy. The deformation metal actuator (8) is a medical nickel-titanium alloy, and its austenitic phase transformation end temperature is higher than the human body temperature and lower than 45 degrees Celsius. The deformation metal actuator (8) can be a mesh sleeve design.

8. The leak-proof catheter with radially adjustable function according to any one of claims 1-7, characterized in that: In the non-inflated state, the fluid-driven airbag (5) is completely housed in the annular assembly groove, and the outer wall of the fluid-driven airbag (5) does not extend beyond the outer wall of the urinary catheter functional part (2).

9. The leak-proof catheter with radially adjustable function according to claim 8, characterized in that: The balloon fixation device includes a first conduit (12) located inside the ureter tip (1) and the ureter functional part (2). The first conduit (12) extends out of the tail of the ureter functional part (2) and can be connected to an air source. A functional balloon (4) is installed outside the ureter tip (1). The functional balloon (4) will not interfere with the insertion process of the ureter tip (1) and the ureter functional part (2) when it is in a contracted state. The first conduit (12) is connected to the functional balloon (4). The functional balloon (4) will deform and expand when the air pressure inside it increases.

10. The leak-proof catheter with radially adjustable function according to claim 8, characterized in that: The urinary catheter tip (1) is also provided with a drainage hole (3), which is connected to the interior of the urinary catheter tip (1). The diameter of the drainage hole (3) gradually decreases from the outside to the inside, and the cross-section of the hole is a rounded rectangle.

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