Disposable expandable urethral dilation bag

Abstract

A disposable urethral stenosis expansion bag comprises an expandable urethral probe rod, the expandable urethral probe rod is made of flexible high polymer materials, the tail end of the expandable urethral probe rod is provided with a multi-cavity expansion structure, and the multi-cavity expansion structure comprises an inner layer supporting grid, an outer layer elastic film and a covered antibacterial coating. The multi-cavity expansion structure is connected with the inflation connector and the exhaust connector through a double-channel pipeline arranged in the expandable urethra feeler lever. The sterile glove is made of a medical butyronitrile material, and a lubricating bag is arranged in the glove; the disinfection bag comprises a soft plastic shell, a separation cavity is formed in the soft plastic shell, and chlorine-containing disinfectant and alcohol auxiliary solution are contained in the separation cavity. The urethral dilatation device effectively solves the problems that existing urethral dilatation equipment is insufficient in operation precision, insufficient in depth control, inconvenient to disinfect and lubricate, lack of real-time monitoring function and the like.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, specifically relating to a disposable expandable urethral dilator. Background Technology

[0002] Urethral stricture is a common urological condition, primarily caused by inflammation, trauma, surgery, or other pathological factors. For patients with moderate to severe urethral stricture, dilation therapy is commonly used clinically to gradually widen the urethral diameter and restore normal urination function. Traditional urethral dilation methods mainly rely on metal or disposable plastic probes. While these devices can perform basic dilation procedures, they still present several problems in practical use.

[0003] Current urethral dilation devices typically include the following types: 1. Metal probe type: Metal probes have good strength and rigidity, but due to their rigid material, they can easily damage the urethral mucosa. Furthermore, metal probes require repeated disinfection and use, posing a risk of cross-infection. 2. Disposable plastic probes: Plastic probes are highly flexible, but most lack sophisticated design, making it difficult to meet the dilation needs of different degrees of urethral stricture. Their simple structure usually prevents multi-stage dilation and lacks real-time monitoring capabilities, limiting clinical operational precision. 3. Balloon-type urethral dilation devices: Some devices use balloons for dilation. While providing a certain degree of flexible dilation, the balloon's expansion range is difficult to control precisely, posing a risk of over- or under-dilation. Additionally, their operation is complex, increasing the workload of medical staff.

[0004] In addition to the above, the following problems exist in actual operation: 1. Insufficient depth control: Traditional dilation probes lack effective depth control devices, making it difficult to accurately control the insertion depth and increasing the risk of urethral injury. 2. Inconvenient lubricant use: Currently, additional lubricant is usually required during dilation, and lubricant is mostly provided in external containers, which is cumbersome and increases the possibility of cross-contamination. 3. Complex disinfection process: The disinfection devices used to assist in the operation lack an integrated design, requiring medical personnel to prepare additional disinfectant and tools, making the operation process cumbersome and affecting efficiency. 4. Lack of real-time monitoring function: Existing equipment usually cannot provide real-time feedback on the pressure and local temperature of the expansion chamber during dilation, making it difficult to provide effective safety assurance.

[0005] In summary, existing technologies have limitations in the design of urethral dilation devices, making it difficult to simultaneously meet the requirements of precision, safety, efficiency, and convenience. Therefore, developing a disposable expandable urethral dilation kit that integrates a multi-chamber expansion structure, a depth control module, a real-time monitoring module, and aseptic operation auxiliary components can effectively solve the above problems and has significant clinical application value and promising prospects for widespread application. Utility Model Content

[0006] This invention addresses the shortcomings of existing technologies by providing a disposable expandable urethral dilation kit, which effectively solves the problems of insufficient operational precision, lack of depth control, inconvenient disinfection and lubrication, and lack of real-time monitoring function in existing urethral dilation equipment.

[0007] The technical solution adopted by this utility model to solve the above problems is as follows:

[0008] A disposable expandable urethral dilator kit, comprising:

[0009] An expandable urethral probe, the expandable urethral probe being made of flexible polymer material, having a multi-cavity expansion structure at its end, the multi-cavity expansion structure including an inner supporting mesh, an outer elastic membrane and a covering antibacterial coating, the multi-cavity expansion structure being connected to an inflation port and an exhaust port respectively through a dual-channel pipe built into the expandable urethral probe;

[0010] An integrated depth control module is disposed on the outer wall of the expandable urethral probe. The depth control module includes a sliding limiting ring with a locking device for limiting the insertion depth of the expandable urethral probe. The locking device is fixed in a preset slot of the expandable urethral probe by pressing.

[0011] A real-time monitoring module is embedded inside the expandable urethral probe. The monitoring module includes a pressure sensor and a temperature sensor. The sensors are connected to a display device at the tail of the expandable urethral probe via wires to provide real-time feedback on the pressure and local temperature within the expansion chamber.

[0012] The sterile gloves are made of medical nitrile material. The gloves have a built-in lubrication pack, which includes a storage chamber and a release chamber. The storage chamber is pre-filled with a silicone-containing lubricant, and the release chamber is connected to the inner wall of the gloves through a one-way valve.

[0013] The disinfection packaging includes a soft plastic shell with an internal partitioned cavity containing a chlorine-based disinfectant and an alcohol-based auxiliary solution. The outer shell of the partitioned cavity has a bidirectional extrusion channel for releasing different disinfectants separately.

[0014] The outer packaging shell is a multi-layer composite film design, including an outer moisture-proof film, a middle high-strength support layer, and an inner sterilization film.

[0015] Preferably, the multi-cavity expansion structure of the expandable urethral probe includes multiple sequentially arranged expansion cavities, which are separated by an annular isolation membrane made of thermoplastic elastomer material with a thickness of 0.1 mm to 0.3 mm. The annular isolation membrane is fixed to the outer wall of the expansion cavity by a hot-melt process. The cavity wall thickness of each expansion cavity is 0.2 mm to 0.5 mm, and a support grid is provided on the inner surface of the cavity. The support grid is made of polyurethane material, and the grid unit is a regular hexagonal structure with a side length of 0.5 mm to 1 mm.

[0016] The expandable urethral probe is equipped with an inflation pipeline system, which includes a main inflation pipeline and multiple branch pipelines connected to each expansion chamber. The ends of the branch pipelines are connected to each expansion chamber through one-way control valves embedded in the expandable urethral probe. The one-way control valves are used to control the gas entering a specific expansion chamber.

[0017] Preferably, the depth control module includes a sliding limiting ring disposed on the outer wall of the expandable urethral probe. The sliding limiting ring is made of elastic silicone material, and its inner diameter is slightly smaller than the outer diameter of the expandable urethral probe. Multiple flexible locking protrusions are arranged circumferentially on the inner side of the sliding limiting ring. These locking protrusions cooperate with the slots on the outer wall of the expandable urethral probe. The height of the locking protrusions is 0.2 mm to 0.5 mm, and the width is 0.2 mm to 0.4 mm. The sliding limiting ring is embedded into the slots on the outer wall of the expandable urethral probe through flexible deformation, achieving stable engagement of the sliding limiting ring.

[0018] Preferably, the lubrication pack of the sterile glove includes a storage cavity and a release cavity. The storage cavity is a flexible, closed, sac-like structure. The outer wall of the storage cavity is made of thermoplastic elastomer material with a thickness of 0.1 mm to 0.3 mm. The storage cavity is pre-filled with a silicone-containing lubricant. The storage cavity and the release cavity are connected by a one-way valve, which is embedded in the lower end wall of the storage cavity. The release cavity is a flexible sheet-like structure with uniformly distributed micropores on its outer surface. The diameter of the micropores is 10 μm to 50 μm, and the spacing between the micropores is 0.5 mm to 1 mm. The release cavity is sealed to the lower end of the storage cavity by a ring-shaped hot-melt process and the lubricant is discharged to the outer surface of the glove through the micropores.

[0019] Preferably, the antibacterial coating on the outer layer of the expandable urethral probe includes a silver ion coating. The coating is deposited on the outer surface of the expandable urethral probe by a vacuum deposition process, and the coating thickness is 5 μm to 15 μm. The silver ion coating and the outer wall of the expandable urethral probe are bonded together by a nanoscale transition layer. The transition layer is made of silica material and has a thickness of 1 μm to 3 μm, which is used to improve the adhesion and corrosion resistance of the coating.

[0020] Preferably, the bidirectional extrusion channel for sterilization packaging includes two symmetrically arranged flexible extrusion chambers. The extrusion chambers are made of medical-grade silicone material with a thickness of 0.3 mm to 0.5 mm. The inner wall of the extrusion chamber is provided with a flow guide channel with a diameter of 2 mm to 5 mm. An independent anti-backflow valve is provided at the outlet end of the flow guide channel.

[0021] Preferably, the outer packaging shell includes an inner sterilization film, a middle support layer, and an outer moisture-proof film. The inner sterilization film is made of a multi-layer composite material, including a polypropylene film and a polyethylene coating, with a total composite material thickness of 0.05 mm to 0.1 mm. The inner sterilization film is bonded to the middle support layer by a hot-pressing process. The middle support layer is made of high-density polyethylene material with a thickness of 0.1 mm to 0.3 mm. The outer moisture-proof film is made of polyethylene terephthalate (PET) material with a thickness of 0.02 mm to 0.05 mm.

[0022] Preferably, the expandable urethral probe is made of polyurethane material.

[0023] This utility model has a novel structure, ingenious design, and is simple and convenient to operate. Compared with the prior art, it has the following advantages:

[0024] 1. Multi-chamber expansion structure design improves the accuracy and safety of expansion: The expandable urethral probe of this device adopts a multi-chamber expansion structure at the end. It is connected to the inflation port and the exhaust port through the built-in dual-channel pipe. Each expansion chamber is separated by an annular isolation membrane, which supports staged expansion. It can accurately expand for different degrees of urethral stricture and avoid the risk of urethral damage caused by excessive expansion at one time in traditional devices.

[0025] 2. Integrated depth control module ensures stability and controllability of the expandable urethral probe insertion: This device features a sliding limiting ring with a locking device on the outer wall of the expandable urethral probe. The limiting ring is made of elastic silicone material, with a flexible locking protrusion on its inner side, which engages with the groove on the outer wall of the expandable urethral probe. This design effectively limits the insertion depth of the expandable urethral probe, avoiding misoperation caused by the lack of depth control in traditional devices, while also being simple and convenient to operate.

[0026] 3. Real-time monitoring and aseptic operation components enhance the convenience and efficiency of clinical use: This device integrates a real-time monitoring module with pressure and temperature sensors. It can be connected via wires to a display device at the end of the expandable urethral probe, providing real-time feedback on the pressure and temperature of the expansion chamber, ensuring the safety of the dilation procedure. Furthermore, the lubrication pack and sterilization pack with built-in sterile gloves are integrated into a single design. The lubrication pack releases lubricant via a one-way valve, while the sterilization pack releases chlorine-containing disinfectant and alcohol solution through bidirectional compression channels, simplifying the operation process and reducing the risk of cross-contamination. Attached Figure Description

[0027] Figure 1 This is an isometric view of the disposable expandable urethral dilator of this utility model.

[0028] Figure 2 This is a diagram showing the internal structure of the disposable expandable urethral dilator of this invention.

[0029] Figure 3 This is an isometric view of the expandable urethral probe of the disposable expandable urethral dilator kit of this utility model.

[0030] Figure 4 This is an isometric view of the sterile gloves of the disposable expandable urethral dilator kit of this utility model.

[0031] Figure 5 This is an isometric view of the sterilization packaging of the disposable expandable urethral dilator of this utility model.

[0032] In the attached diagram: 1-outer packaging shell, 2-expandable urethral probe, 3-sliding limiting ring, 4-sterile glove, 5-sterilized packaging, 6-multi-cavity expansion structure, 7-lubricating pack, 8-storage cavity, 9-release cavity, 10-separation cavity, 11-bidirectional compression channel. Detailed Implementation

[0033] The following are specific embodiments of the present invention, and the technical solution of the present invention will be further described in conjunction with the accompanying drawings. However, the present invention is not limited to these embodiments.

[0034] like Figure 1-5 As shown, this utility model provides a disposable expandable urethral dilation kit, specifically designed to solve the problems of inconvenient operation, insufficient accuracy, and infection risk of existing urethral dilation devices. The kit mainly consists of the following components: an expandable urethral probe 2, an integrated depth control module, a real-time monitoring module, sterile gloves 4, a sterilization pack 5, and an outer packaging shell 1. All components are tightly integrated and have a reasonable functional design.

[0035] The expandable urethral probe 2 is made of polyurethane, which has excellent flexibility and biocompatibility. The end of the probe is equipped with a multi-chamber expansion structure 6, which consists of an inner support mesh, an outer elastic membrane, and a covering antibacterial coating. The inner support mesh is made of polyurethane mesh material with a hexagonal unit structure, providing uniform support; the outer elastic membrane is made of thermoplastic elastomer with a thickness of 0.1 mm to 0.3 mm, capable of adapting to different degrees of expansion; the antibacterial coating is deposited using a vacuum coating process, with a coating thickness of 5 μm to 15 μm, effectively inhibiting the growth of pathogens. The multi-chamber expansion structure 6 is connected to the inflation and deflation ports respectively through a dual-channel pipe built into the probe, achieving precise gas input and output, avoiding over-expansion or insufficient pressure.

[0036] The integrated depth control module includes a sliding limiting ring 3, which is made of elastic silicone material. Its inner diameter is slightly smaller than the outer diameter of the probe, and multiple flexible locking protrusions are distributed circumferentially on its inner side, tightly engaging with pre-set grooves on the outer wall of the probe. The outer side of the sliding limiting ring 3 is engraved with recessed depth markings for visually displaying the insertion depth. The limiting ring is embedded into the outer wall of the probe through flexible deformation, allowing for stable locking at different positions and preventing excessive probe insertion that could cause urethral injury.

[0037] The real-time monitoring module is embedded inside the probe rod 2. The module includes a pressure sensor, a temperature sensor, wires, and a display device. The pressure and temperature sensors are installed in a sensing cavity inside the probe rod, located near the tail end of the expansion chamber. They are fixed to the inner wall of the probe rod using a heat-sealing process to prevent liquid or gas ingress. The pressure sensor is a miniature silicon piezoresistive sensor, measuring 5 mm × 5 mm × 2 mm, and is fixed to the bottom of the sensing cavity. The sensor's detection surface is in direct contact with the inside of the expansion chamber through a flexible thermally conductive silicone layer. Its input end is connected to a detection hole on the inner wall of the expansion chamber via a conduit. The detection hole has a diameter of 0.5 mm to 1 mm and is used to sense real-time pressure changes within the expansion chamber. The sensor's output end is connected to the display device at the tail end of the probe rod via a flexible flat cable (FFC).

[0038] The temperature sensor is a resistance temperature detector (RTD) sensor, measuring 3 mm × 3 mm × 1 mm. It is fixedly mounted on the side wall of the sensing cavity and firmly bonded to the inner wall using a polymer adhesive. The sensor probe, with a diameter of 0.2 mm to 0.5 mm, extends into the expansion cavity via a flexible wire, allowing direct contact with the gas inside the expansion cavity to sense real-time changes in local temperature. The signal output of the temperature sensor is connected to the display device at the rear via a multi-core shielded cable, ensuring stable signal transmission.

[0039] The wires for the pressure and temperature sensors are arranged in pre-reserved grooves inside the probe rod, with a groove cross-section of 1 mm × 2 mm, parallel to the outer wall of the probe rod. The wires are wrapped with a layer of polyimide insulation material to improve durability and prevent signal interference. The wires ultimately connect to a display device at the tail of the probe rod, housed within a casing at the tail. The display device includes an LCD screen, a microprocessor, and a power supply module. The microprocessor receives data from the pressure and temperature sensors via a signal conversion module and displays the pressure and temperature information within the expansion chamber in real time on the screen. The display device is secured to the tail casing of the probe rod using a snap-fit ​​structure for easy assembly and maintenance. The power supply module uses a 100 mAh to 300 mAh lithium battery, which is soldered to the display device's circuit board.

[0040] The sensing chamber of the probe is sealed with a medical-grade silicone sealing ring to ensure that the working environment of the pressure and temperature sensors is protected from interference from external liquids or gases. A rubber sealing gasket is provided at the outlet where the wire exits the probe, further enhancing the overall sealing performance and protection of the probe.

[0041] The sterile glove 4 is made of medical-grade nitrile material and has a built-in lubrication pack 7, which consists of a storage chamber 8 and a release chamber 9. The storage chamber 8 is a flexible, closed, sac-like structure pre-filled with silicone-containing lubricant and is connected to the release chamber 9 via a one-way valve. The outer surface of the release chamber 9 has uniformly distributed micropores, through which the lubricant is discharged to the outer surface of the glove, simplifying the lubrication process and avoiding cross-contamination.

[0042] The shell of the disinfection package 5 is made of soft plastic, and its interior has a partitioned cavity 10 containing chlorine-based disinfectant and alcohol-based auxiliary solution. The outer shell of the partitioned cavity has a bidirectional extrusion channel 11, and the channel outlet is equipped with an independent anti-backflow valve, which can precisely control the release of disinfectant. Through the bidirectional extrusion design, different types of disinfectant can be released separately for efficient disinfection of instrument surfaces or patient areas.

[0043] The outer packaging shell 1 adopts a multi-layer composite film structure, including an outer moisture-proof film, a middle high-strength support layer, and an inner sterilization film. The surface of the inner sterilization film has a preset tear line, and the depth of the linear groove structure is 50% to 70% of the film thickness. Reinforcing holes are provided at both ends to ensure that the packaging is easy to tear without affecting sterility.

[0044] The multi-cavity expansion structure 6 of the expandable urethral probe 2 consists of multiple sequentially arranged expansion cavities, each separated by an annular isolation membrane to form an independent expansion unit. The annular isolation membrane is made of thermoplastic elastomer (TPE) material, possessing excellent flexibility and sealing properties, with a thickness ranging from 0.1 mm to 0.3 mm. The outer edge of the isolation membrane is fixed to the outer wall of the expansion cavity via a heat-sealing process, while the inner edge completely seals both ends of the expansion cavity, ensuring that gas does not leak into adjacent cavities during expansion. The wall thickness of each expansion cavity ranges from 0.2 mm to 0.5 mm, meeting expansion strength requirements while maintaining a certain degree of flexibility to reduce irritation to the urethra.

[0045] The inner surface of the expansion chamber is equipped with a support grid made of polyurethane material. The grid units are designed as regular hexagonal structures with side lengths ranging from 0.5 mm to 1 mm. This structure can evenly distribute the pressure within the expansion chamber, preventing it from rupturing due to excessive localized stress. It also reduces the chamber wall thickness, improving the device's flexibility and user comfort. The multi-chamber design allows the probe to expand in stages, achieving precise dilation of the urethra at different degrees of stenosis through independent inflation, avoiding the problem of excessive dilation in a single step common with traditional devices.

[0046] The probe 2 has an internal inflation and deflation piping system, which includes a main inflation pipe, a main deflation pipe, and branch pipes connecting to each expansion chamber. The main inflation and deflation pipes are arranged along the longitudinal axis of the probe, with a diameter of 2 mm to 4 mm, and are made of medical-grade silicone, offering good flexibility and sealing. The branch pipes are connected to the main inflation pipe, main deflation pipe, and expansion chambers via Y-connectors, and are integrally molded using a precision injection molding process to ensure unobstructed and sealed gas passages.

[0047] Each branch pipe is equipped with a one-way control valve at its end. The one-way control valve employs a plate-type elastic seal structure, with the valve body made of polyamide material and the valve plate thickness ranging from 0.05 mm to 0.1 mm. During inflation, the inflation channel of the one-way control valve opens, allowing gas to flow from the main inflation pipe through the branch pipe into the specific expansion chamber. When deflation is required, the centralized control button at the end of the probe controls the deflation channel of the one-way control valve via a mechanical linkage, allowing gas to exit from the expansion chamber through the branch pipe into the main deflation pipe. If individual deflation of a specific expansion chamber is required, medical personnel can operate the electromagnetic switch via the selection button on the display device to precisely control the deflation channel of the target expansion chamber, while other expansion chambers remain closed.

[0048] The depth control module includes a sliding limiting ring 3 disposed on the outer wall of the expandable urethral probe 2. The sliding limiting ring 3 is made of elastic silicone material, which ensures both flexibility and sufficient rebound force to achieve stable locking. The inner diameter of the sliding limiting ring 3 is slightly smaller than the outer diameter of the probe 2, and multiple flexible locking protrusions are distributed circumferentially on its inner side. The height of the locking protrusions is 0.2 mm to 0.5 mm, and the width is 0.2 mm to 0.4 mm. These locking protrusions cooperate with the grooves on the outer wall of the probe 2 through flexible deformation to achieve a firm fixation of the sliding limiting ring 3.

[0049] The sliding limit ring 3 employs a mechanical connection design. Multiple slots are evenly distributed axially along the outer wall of the probe 2, with a depth ranging from 0.3 mm to 0.6 mm and a width matching the width of the locking protrusion. During assembly, the sliding limit ring 3 is manually deformed by applying force, causing the locking protrusion to slide along the slots until it reaches the target position. When the sliding limit ring 3 reaches the target slot, the rebound force of the silicone material automatically embeds the locking protrusion into the slot, forming a stable connection. This design ensures both flexible adjustment of the sliding limit ring 3 and avoids positioning inaccuracies caused by slippage or displacement during operation.

[0050] The outer surface of the sliding limiting ring 3 is designed with recessed scale markings, distributed circumferentially in 1 mm increments, with a depth ranging from 0.1 mm to 0.3 mm, ensuring that the scale is not easily worn during long-term use. Corresponding scale lines are also provided on the outer wall of the probe 2. Together, these markings visually indicate the depth of probe insertion. Medical personnel can precisely adjust the position of the sliding limiting ring 3 according to clinical needs, ensuring that the probe insertion depth meets treatment requirements and reducing the risks associated with excessive or insufficient insertion.

[0051] In addition, the sliding limit ring 3 is made of medical-grade silicone, and its surface is polished to prevent scratches on the outer wall of the probe during adjustment. The inner side of the limit ring that contacts the probe is also coated with a medical-grade lubricating coating (such as a polytetrafluoroethylene coating) to further reduce sliding resistance and improve the smoothness of adjustment and ease of operation.

[0052] The lubrication pack 7 of the sterile glove 4 is designed to provide efficient and convenient lubrication during operation, ensuring the safety and comfort of medical procedures. The lubrication pack 7 consists of a storage chamber 8 and a release chamber 9, which are connected by a one-way valve to form a complete lubrication release system.

[0053] The storage chamber 8 is a flexible, closed, sac-like structure. Its outer wall is made of thermoplastic elastomer (TPE) material with a thickness ranging from 0.1 mm to 0.3 mm, providing both good flexibility and ensuring the chamber's durability and sealing. The storage chamber 8 is pre-filled with a certain amount of silicone-containing lubricant (2 ml to 5 ml). This lubricant has good adhesion and lubricity, used to reduce frictional resistance during probe insertion. A one-way valve is embedded in the lower wall of the storage chamber 8. The one-way valve employs a thin-plate elastic sealing design, with the valve body made of polyamide material and the valve plate thickness ranging from 0.05 mm to 0.1 mm. This allows for precise control of the one-way flow of the lubricant, preventing external contaminants from flowing back into the storage chamber.

[0054] The release chamber 9 and the storage chamber 8 are sealed together via a ring-shaped heat-sealing process. The release chamber is a flexible sheet-like structure with micropores evenly distributed on its outer surface. The diameter of the micropores ranges from 10 μm to 50 μm, and the spacing is from 0.5 mm to 1 mm. The micropore design allows the lubricant to be evenly diffused onto the outer surface of the glove through capillary action, thereby achieving rapid coating of probes or other medical devices. The thickness of the release chamber is controlled within the range of 0.05 mm to 0.2 mm to ensure both efficient lubricant release and comfortable glove wear.

[0055] During operation, medical personnel gently squeeze the storage chamber 8 while wearing the gloves. The lubricant inside the chamber flows into the release chamber 9 through a one-way valve. Under the squeezing pressure, the lubricant in the release chamber is evenly squeezed out and distributed on the outer surface of the glove through micropores, forming a thin and uniform lubricating film. This process requires no additional auxiliary tools, is simple and convenient to operate, and the amount of lubricant released can be adjusted by the squeezing force, ensuring accuracy and economy in use.

[0056] Furthermore, to prevent accidental lubricant leakage, the connection between storage chamber 8 and release chamber 9, as well as the edges of the micropores, are reinforced, and the sealing performance is improved through a high-temperature hot-pressing process. The sealing performance of the one-way valve has also been rigorously calibrated, with an opening pressure range of 0.1 N to 0.3 N. The valve only opens when the storage chamber is compressed, ensuring that the lubricant does not leak out when not in use.

[0057] The outer antibacterial coating of the expandable urethral probe 2 is designed with silver ion coating. The coating is uniformly deposited on the outer surface of the probe through a vacuum coating process, with a thickness controlled in the range of 5 μm to 15 μm. The silver ion coating, with its excellent broad-spectrum antibacterial properties, effectively inhibits the growth of common pathogens, including Staphylococcus aureus and Escherichia coli, significantly reducing the risk of infection during use.

[0058] To enhance the adhesion between the coating and the outer wall of the probe, a nanoscale transition layer is placed between the silver ion coating and the probe. This transition layer, made of silica (SiO2) with a thickness of 1 μm to 3 μm, is formed using a chemical vapor deposition (CVD) process. Silica possesses excellent chemical inertness and corrosion resistance, which not only improves the adhesion of the coating but also provides a degree of protection, preventing the silver ion coating from peeling off or oxidizing during long-term use.

[0059] The silver ion coating is deposited using a vacuum deposition process, with the following steps: First, the probe 2 is placed in a vacuum deposition apparatus, maintaining a vacuum level below 10⁻³ Pa to avoid interference from impurities. Then, silver ions are deposited layer by layer onto the outer surface of the probe using sputtering deposition technology in the form of an ion beam, while controlling the deposition rate to ensure uniform coating thickness. The particle diameter of the silver ion layer is controlled within the range of 10 nm to 50 nm. The arrangement of these nano-sized particles increases the effective surface area of ​​the coating, thereby enhancing the antibacterial effect.

[0060] During operation, the silver ions in the silver ion coating are gradually released. Upon contact with the cell walls of pathogens, they disrupt the cell wall structure and interfere with the activity of enzymes within the bacteria, thereby achieving an antibacterial effect. Since the release rate of silver ions is affected by both the coating thickness and the ambient humidity, this coating design enables a slow-release effect, ensuring the durability of the antibacterial performance.

[0061] Furthermore, the presence of the nanoscale transition layer prevents a chemical reaction between the silver ion coating and the outer wall of the probe, thus improving the coating's durability. The outer wall of the probe is made of a flexible polymer material, which forms a physical locking effect with the silica transition layer, thereby ensuring the stability and wear resistance of the coating during use while maintaining the probe's flexibility.

[0062] The disinfection package 5 is designed as a portable dual-chamber structure, equipped with a bidirectional extrusion channel 11 for separately releasing chlorine-containing disinfectant and alcohol-assisted solution to meet different disinfection needs. The bidirectional extrusion channel includes two symmetrically arranged flexible extrusion chambers, each made of medical-grade silicone material with a thickness ranging from 0.3 mm to 0.5 mm, possessing good flexibility and tear resistance, and capable of withstanding multiple extrusion operations.

[0063] A flow guide channel is installed inside the extrusion chamber, running axially through it. The channel has a diameter of 2 mm to 5 mm and is supported by a uniform flow-guiding texture on its inner wall, ensuring stable liquid flow within the channel. Each flow guide channel has an independent anti-backflow valve at its outlet. This valve employs a thin-plate elastic sealing design, is made of medical-grade polyamide material, and has a valve plate thickness of 0.05 mm to 0.1 mm. The anti-backflow valve is installed at the outlet end of the flow guide channel via a snap-fit ​​structure, forming an integrated, sealed connection with the extrusion chamber.

[0064] During use, medical personnel can manually squeeze the corresponding flexible squeezing chamber to control the release of the disinfectant. When the squeezing chamber is squeezed by external force, the liquid inside flows towards the outlet through the guide channel, simultaneously opening the anti-backflow valve to release the liquid to the outside. The anti-backflow valve quickly rebounds and closes after the liquid pressure disappears, preventing outside air or contaminants from entering the squeezing chamber and maintaining the sterility of the disinfectant.

[0065] The bidirectional extrusion channel design allows for the simultaneous storage of two different disinfectants (such as chlorine-based disinfectant and alcohol-based auxiliary solution) in the sterilization packaging, with each extrusion chamber corresponding to one disinfectant. The separation structure of the extrusion chambers prevents mixing or cross-contamination between liquids, ensuring the independence and safety of each disinfectant. Furthermore, the flexible material of the extrusion chambers allows for rapid shape recovery, facilitating multiple operations without affecting performance.

[0066] The outer packaging shell 1 is designed with a three-layer composite structure to ensure that the internal instruments remain sterile during transportation and storage and to prevent the influence of the external environment. The outer packaging shell includes an inner sterilization film, a middle support layer, and an outer moisture-proof film. The layers are tightly integrated to achieve the protective function.

[0067] The inner sterilization membrane is made of a multi-layer composite material, specifically consisting of a polypropylene (PP) film and a polyethylene (PE) coating. The total thickness of the composite material is controlled within the range of 0.05 mm to 0.1 mm. The polypropylene film, as the inner substrate, possesses good mechanical strength and puncture resistance, while the polyethylene coating provides excellent sealing and chemical inertness, effectively preventing the penetration of microorganisms and moisture. The inner sterilization membrane is tightly bonded to the middle support layer through a high-temperature hot-pressing process, forming a robust integral structure while preventing delamination.

[0068] The middle support layer is made of high-density polyethylene (HDPE) with a thickness of 0.1 mm to 0.3 mm, primarily serving to enhance the rigidity and compression resistance of the packaging. Under external forces, the middle support layer effectively disperses pressure, preventing internal components from deforming or being damaged by external compression or impact. Simultaneously, the high weather resistance of this layer ensures that the packaging shell maintains stable performance under various climatic conditions.

[0069] The outer moisture-proof film is made of polyethylene terephthalate (PET) material, with a thickness of 0.02 mm to 0.05 mm, and its surface undergoes a special moisture-proof treatment. PET material has excellent waterproof and chemical corrosion resistance, effectively preventing the intrusion of external moisture and chemicals, while providing good optical transparency, allowing medical personnel to visually inspect the integrity of the instruments inside the packaging. The outer moisture-proof film is laminated with the middle support layer, further enhancing the overall airtightness of the packaging.

[0070] ① During preparation, medical personnel first check the integrity of the outer packaging shell to ensure it is undamaged or contaminated. Then, they easily tear open the outer packaging shell along the pre-set tear line to remove the sterile gloves, expandable urethral probe, and disinfection package, placing them on a sterile operating table for later use. Simultaneously, they check the working status of the display device at the probe's tail to ensure the real-time monitoring module is functioning correctly. ② After putting on the sterile gloves, open the disinfection package. Select either chlorine-based disinfectant or alcohol-based auxiliary solution as needed. By squeezing the bidirectional squeezing channel of the disinfection package, release an appropriate amount of disinfectant around the patient's urethral inlet and onto the probe surface, ensuring a sterile environment for the operating area and instruments. After disinfection, wait a few seconds to ensure the disinfectant completely covers the target area, while avoiding excessive disinfectant residue that could affect subsequent lubrication. ③ After the disinfection step is complete, gently squeeze the lubrication pack inside the glove to allow the silicone-containing lubricant in the storage chamber to flow into the release chamber through the one-way valve. The lubricant then seeps out evenly through the micropores on the surface of the release chamber, coating the outer surface of the glove. Subsequently, medical personnel evenly applied lubricant from their gloves to the surface of the expandable urethral probe to reduce frictional resistance to the urethral mucosa during insertion and ensure uniform lubrication. ④ The lubricated probe tip was aligned with the patient's urethral inlet and slowly inserted into the urethra, with the insertion depth precisely adjusted using the sliding limit ring. The markings on the sliding limit ring correspond to the markings on the probe, allowing medical personnel to adjust the depth according to the patient's condition, ensuring the probe is inserted to the appropriate position without causing urethral damage. ⑤ The inflation device was connected, and gas was gradually injected into the expansion chamber through the inflation port at the probe's tail. The pressure and temperature within the expansion chamber were monitored in real-time using a display device to ensure the dilation operation was performed within safe limits. Depending on the degree of urethral stricture, multiple expansion chambers were independently inflated in stages, adjusting the inflation volume until the desired dilation effect was achieved, while continuously observing changes in the display data to ensure the accuracy and safety of the dilation process. ⑥ After the dilation procedure is complete, stop inflation and press the deflation button to quickly release the gas in the expansion chamber through the deflation channel inside the probe, while preventing backflow of gas through the one-way valve. After confirming that all expansion chambers are completely deflated, slowly withdraw the probe from the urethra to reduce additional irritation to the urethral mucosa. ⑦ After the procedure, dispose of the probe, gloves, and sterilized packaging as medical waste, and make relevant records, including real-time monitoring data on the display device, to provide effective reference for the patient's subsequent treatment.

[0071] The specific embodiments described herein are merely illustrative examples illustrating the spirit of this utility model. Those skilled in the art to which this utility model pertains may make various modifications or additions to the described specific embodiments or use similar methods to replace them, without departing from the spirit of this utility model or exceeding the scope defined by the appended claims.

Claims

1. A disposable inflatable urethral dilating pack, characterized by, The utility model relates to a kind of inflatable urethral sound rod, which comprises: An inflatable urethral sound rod (2) made of flexible polymer material, the distal end of which is provided with a multi-cavity expansion structure (6) comprising an inner layer support grid, an outer layer elastic film and a covered antibacterial coating, the multi-cavity expansion structure (6) is connected with a gas filling interface and a gas exhaust interface respectively through a double-channel pipeline built-in the inflatable urethral sound rod (2); An integrated depth control module is arranged on the outer wall of the inflatable urethral sound rod (2), which comprises a sliding limiting ring (3) with a locking device for limiting the insertion depth of the inflatable urethral sound rod (2), and the locking device is fixed in a preset clamping groove of the inflatable urethral sound rod (2) by pressing; A real-time monitoring module is embedded in the inflatable urethral sound rod (2), which comprises a pressure sensor and a temperature sensor, and the sensors are connected with a display device at the tail of the inflatable urethral sound rod (2) through wires for real-time feedback of the pressure and local temperature in the inflation cavity. A sterile glove (4) made of medical butyronitrile material, which is provided with a lubricating bag (7) inside, the lubricating bag (7) comprises a storage cavity (8) and a release cavity (9), the storage cavity (8) is preloaded with a silicon-containing lubricant, and the release cavity (9) is communicated with the inner wall of the glove through a one-way valve. A disinfection package (5) comprising a soft plastic shell, which is provided with a partition cavity (10) inside, the partition cavity (10) contains chlorine-containing disinfectant and alcohol-based auxiliary solution, and the partition cavity (10) is provided with a two-way extrusion channel (11) on the shell for releasing different disinfectants respectively. An outer packaging shell (1) designed as a multi-layer composite film, which comprises an outer moisture-proof film, a middle high-strength support layer and an inner sterilization film.

2. The disposable inflatable urethral dilation pack of claim 1, wherein: The multi-cavity expansion structure (6) of the inflatable urethral sound rod (2) comprises a plurality of sequentially arranged inflation cavities, which are isolated by an annular isolation film made of thermoplastic elastomer material with a thickness of 0.1 mm to 0.3 mm, and the annular isolation film is fixed with the outer wall of the inflation cavity through a hot melting process; the cavity wall thickness of each inflation cavity is 0.2 mm to 0.5 mm, and the inner surface of the cavity is provided with a support grid made of polyurethane material, and the grid unit is a regular hexagonal structure with a side length of 0.5 mm to 1 mm. The inflatable urethral sound rod (2) is provided with a gas filling pipeline system, which comprises a main gas filling pipeline and a plurality of branch pipelines connected with each inflation cavity, the distal end of the branch pipeline is connected with each inflation cavity through a one-way control valve embedded in the inflatable urethral sound rod (2), and the one-way control valve is used to control the gas into a specific inflation cavity.

3. The disposable inflatable urethral dilation pack of claim 1, wherein, The depth control module includes a sliding limiting ring (3) arranged on the outer wall of the inflatable urethral probe (2), the sliding limiting ring (3) is made of elastic silica gel material, the inner diameter of the sliding limiting ring (3) is slightly smaller than the outer diameter of the inflatable urethral probe (2), a plurality of flexible locking protrusions are arranged on the inner side of the sliding limiting ring (3) in the circumferential direction, the locking protrusions are matched with the clamping grooves on the outer wall of the inflatable urethral probe (2), the height of the locking protrusions is 0.2 mm to 0.5 mm, the width of the locking protrusions is 0.2 mm to 0.4 mm, the sliding limiting ring (3) is embedded into the clamping grooves on the outer wall of the inflatable urethral probe (2) through flexible deformation, and stable clamping of the sliding limiting ring (3) is realized.

4. The disposable inflatable urethral dilation pack of claim 1, wherein, The lubricating bag (7) of the sterile glove (4) includes a storage cavity (8) and a release cavity (9), the storage cavity (8) is a flexible closed capsule structure, the outer wall of the storage cavity (8) is made of thermoplastic elastomer material, the thickness is 0.1 mm to 0.3 mm, the storage cavity (8) is preloaded with a silica-containing lubricant, the storage cavity (8) and the release cavity (9) are connected through a one-way valve, and the one-way valve is embedded into the lower end wall of the storage cavity (8); the release cavity (9) is a flexible sheet structure, a plurality of micropores are uniformly arranged on the outer surface of the release cavity (9), the diameter of the micropores is 10 μm to 50 μm, the spacing between the micropores is 0.5 mm to 1 mm, the release cavity (9) is sealingly connected with the lower end of the storage cavity (8) through an annular hot melting process, and the lubricant is guided out to the outer surface of the glove through the micropores.

5. The disposable inflatable urethral dilation package of claim 1, wherein, The antibacterial coating of the outer layer of the inflatable urethral probe (2) includes a silver ion coating, the coating is deposited on the surface of the outer wall of the inflatable urethral probe (2) through a vacuum coating process, the thickness of the coating is 5 μm to 15 μm, the silver ion coating is combined with the outer wall of the inflatable urethral probe (2) through a nanoscale transition layer, the transition layer is made of silica material, the thickness is 1 μm to 3 μm, and the transition layer is used to improve the adhesion and corrosion resistance of the coating.

6. The disposable inflatable urethral dilation package of claim 1, wherein, The two-way extrusion channel (11) of the disinfection packaging (5) includes two symmetrically arranged flexible extrusion cavities, the extrusion cavities are made of medical silica gel material, the thickness is 0.3 mm to 0.5 mm, the inner wall of the extrusion cavity is provided with a flow guide channel, the diameter of the flow guide channel is 2 mm to 5 mm, and the outlet end of the flow guide channel is provided with an independent anti-reflux valve.

7. The disposable inflatable urethral dilation package of claim 1, wherein, The outer packaging shell (1) includes an inner layer sterilization film, a middle layer support layer and an outer layer moisture-proof film, the inner layer sterilization film is made of a multilayer composite material, including a layer of polypropylene film and a layer of polyethylene coating, the total thickness of the composite material is 0.05 mm to 0.1 mm; the inner layer sterilization film is combined with the middle layer support layer through a hot pressing process, the middle layer support layer is made of high-density polyethylene material, the thickness is 0.1 mm to 0.3 mm, and the outer layer moisture-proof film is made of polyethylene terephthalate (PET) material, the thickness is 0.02 mm to 0.05 mm.

8. The disposable inflatable urethral dilation package of claim 1, wherein, The inflatable urethral probe (2) is made of polyurethane material.

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