Intelligent urine specimen collection device

Abstract

The present application relates to the technical field of medical devices, and more particularly to a urine specimen intelligent collection device, comprising: a urine collection funnel module, a bottom liquid outlet of which is connected to a liquid inlet end of an automatic shunt valve control module; the automatic shunt valve control module is used for sequentially shunting sequentially-inflown urine to a front section interception channel, a middle section diversion channel and a rear section overflow channel based on the volume of the collected urine; a vacuum collection tube connection module is arranged at the end of the middle section diversion channel of the automatic shunt valve control module, is sealingly connected with a vacuum collection tube and uses negative pressure to extract middle section urine; and a sealing and cleaning module comprises a driving motor, a rotary cleaning nozzle and a sterilization unit, and is used for flushing and sterilizing the fluid channel inside the device after collection is completed. The present application solves the technical problem that middle section urine interception is prone to pollution in the urine collection process in the prior art.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an intelligent urine sample collection device. Background Technology

[0002] In clinical urine testing, the quality of specimen collection directly determines the accuracy of test results and the effectiveness of clinical diagnosis. Current conventional urine collection methods and devices have the following significant drawbacks: Midstream urine is difficult to collect and the specimen is easily contaminated. Clinically, it is usually required to collect midstream urine to avoid contamination by the normal flora at the urethral opening and in the anterior urethra. However, in practice, it is extremely difficult for patients to accurately control the front, middle, and rear segments of urination, often resulting in the mixing of frontstream urine, leading to a very high false-positive rate in urine cultures, wasting medical resources and causing misdiagnosis.

[0003] Open collection methods create unsanitary blind spots and are prone to cross-infection. The existing wide-mouth urine cup method is highly susceptible to leakage, contaminating patients' hands and clothing. Furthermore, nurses need to pour or aspirate the urine from the cup into test tubes, a process that is highly prone to spillage and unpleasant odors, increasing occupational exposure and the risk of nosocomial infection for healthcare workers.

[0004] There is a lack of real-time, objective data verification and anti-counterfeiting mechanisms. Traditional paper or printed barcodes are prone to peeling and becoming blurred in humid environments. More seriously, in physical examinations or special tests, such as toxicology tests, there are frequent instances of cheating by adulterating or substituting samples with water. Furthermore, after urine is excreted, its color and physicochemical properties undergo oxidation or precipitation over time. Traditional collection methods cannot record the initial physical characteristics of urine immediately after excretion, resulting in the loss of important auxiliary diagnostic information.

[0005] Chinese invention patent, publication number CN117918900A, discloses a urine sampling device for laboratory use, comprising: a urinal, a segmented urine collection tube, a midstream urine storage chamber, and a sampling tube. A connecting tube is provided on one side of the urinal, the segmented urine collection tube passes through the connecting tube and is inserted into the urinal, the midstream urine storage chamber is located at one end of the connecting tube, the connecting tube connects the urinal and the midstream urine storage chamber, and the sampling tube is inserted into the midstream urine storage chamber. However, this invention neglects precise interception at the source, requiring the patient to manually press a valve to switch to midstream urine, resulting in an extremely low error tolerance. Summary of the Invention

[0006] Therefore, the present invention provides an intelligent urine sample collection device to overcome the technical problem that mid-stream urine interception is prone to contamination in the prior art during urine collection.

[0007] To achieve the above objectives, the present invention provides an intelligent urine sample collection device, comprising: The urine collection funnel module has its bottom outlet connected to the inlet of the front urine waste chamber; An automatic diversion valve control module is used to sequentially divert collected urine to a front interception channel, a middle diversion channel, and a rear overflow channel. The middle diversion channel and the rear overflow channel are respectively located on the upper side of the front urine waste chamber. The vacuum collection tube connection module includes a urine collection needle-type puncture needle and a tube body positioning slot located at the end of the middle flow channel of the automatic diversion valve control module. The tube body positioning slot is used to fix the inserted vacuum collection tube. The tail end of the urine collection needle-type puncture needle is connected to the middle flow channel, and the tip is covered with a silicone sleeve to puncture the rubber stopper of the vacuum urine collection tube when it is inserted to establish a sealed negative pressure fluid channel. The sealed cleaning module includes a drive motor, a rotating cleaning nozzle, and a sterilization unit, which is used to flush and sterilize the fluid channels inside the device after collection. The sensor assembly includes an infrared temperature sensor, a color sensor, and a control unit mounted on the outer wall of the middle flow channel. The infrared temperature sensor is used to detect the initial temperature of the urine flowing through it for anti-cheating determination.

[0008] Furthermore, in the automatic diversion valve control module, the front urine waste chamber is a cylindrical cavity with a conical constriction structure at the top. The semi-cone angle of the conical constriction is 15° to 30°, and the minimum inner diameter is 8mm to 15mm.

[0009] Furthermore, a first-stage buoyancy control valve is installed inside the front urine waste chamber; The primary buoyancy control valve is a sphere made of closed-cell foamed polyurethane or foamed polypropylene, with a diameter 1.2 to 1.4 times the minimum inner diameter of the conical opening and a density of 0.35 to 0.55 g / cm³. When the liquid level in the cavity reaches a preset level of 10 ml to 20 ml, the float rises along the inner wall of the conical opening and embeds itself at the minimum diameter, thereby blocking the entrance of the front urine waste chamber and allowing subsequent urine to enter the middle guiding channel.

[0010] Furthermore, the inlet of the middle-section guide channel is flush with the top wall of the front urine waste chamber, and its channel cross-section is rectangular or elliptical. The middle-section guide channel extends obliquely from the inlet to the vacuum collection tube connection module.

[0011] Furthermore, the inlet height of the rear overflow channel is higher than the inlet height of the middle guide channel; After the vacuum collection tube completes the negative pressure extraction of the middle section of urine, the level of the subsequently discharged urine rises and is discharged to the outside of the device through the rear overflow channel.

[0012] Furthermore, the rotating cleaning nozzle of the sealed cleaning module is mounted on one side of the automatic diversion valve control module via a miniature ball bearing; a sealing ring is provided at the point where the rotating shaft of the nozzle passes through the top cover to prevent the cleaning fluid from leaking along the rotating shaft to the external circuit area; The rotating nozzle has two fan-shaped nozzles with a spray angle of 60° to 90°, which rotate in conjunction with the drive motor at a speed of 200 rpm to 500 rpm.

[0013] Furthermore, the cleaning solution sprayed by the rotating cleaning nozzle is sterile saline or a disinfectant containing povidone-iodine. After cleaning, the waste liquid is discharged to the outside of the device through the overflow channel in the rear section and the drain outlet in the urine waste liquid chamber in the front section.

[0014] Furthermore, the anti-cheating determination step of the sensor assembly includes: The control unit compares the initial temperature of the urine detected by the infrared temperature sensor with the normal temperature range of human urine; when the detected initial temperature of the urine exceeds the normal temperature range of human urine, it is determined to be an abnormal sample.

[0015] Furthermore, the tail end of the urine collection needle is rigidly connected to the middle channel, and the tip is covered with a medical elastic silicone sheath. When the vacuum urine collection tube is inserted along the positioning groove of the tube body, the needle pierces the silicone sheath and breaks the rubber stopper of the vacuum collection tube to establish a sealed negative pressure fluid channel from the middle channel to the inside of the vacuum collection tube. When the vacuum collection tube is pulled out, the silicone sheath re-wraps the needle tip with its own elasticity.

[0016] Furthermore, the urine collection funnel module is integrally injection molded using polytetrafluoroethylene or modified polypropylene material with added nano-silver ions; the inner wall surface of the urine collection funnel module is etched with biomimetic micro-nano-level guiding groove textures distributed from top to bottom to reduce the surface tension of urine, accelerate urine collection and reduce tube wall residue.

[0017] Compared with existing technologies, the advantages of this invention lie in its use of an automatic diversion valve control module, which incorporates a pre-void urine waste chamber and a first-stage buoyancy control valve. Utilizing the principles of fluid hydraulics and mechanical buoyancy, the float automatically rises and seals the inlet when the liquid level in the chamber reaches a preset value of 10ml to 20ml. This solves the problem of patients' difficulty in accurately controlling the urination period during traditional urine collection, leading to a high false-positive rate in urine cultures due to the easy mixing of pre-void urine. It eliminates subjective operational errors by patients, ensures the purity of midstream urine samples, and significantly reduces misdiagnosis rates and waste of medical resources.

[0018] Furthermore, a vacuum collection tube connection module is incorporated. After the vacuum collection tube is inserted, the puncture needle punctures the rubber stopper, and the midstream urine is directly extracted using the negative pressure of the vacuum tube itself. After removal, the silicone sheath automatically springs back to seal the needle. This solves the problem of open urine cups requiring secondary pouring into test tubes, which easily leads to spillage, odor diffusion, and increased occupational exposure and nosocomial infection risks for medical staff. It achieves a fully closed negative pressure fluid channel from urine collection to specimen collection, eliminating the need for medical staff to come into contact with urine and completely eliminating the risks of contamination, spillage, and infection from secondary operations.

[0019] Furthermore, the integrated sealing and cleaning module automatically flushes and sterilizes the internal fluid channels of the device with deep ultraviolet light after data collection. This solves the problem of dirt and grime accumulating in purely mechanical structures after long-term use, and the potential for cross-contamination between samples during multiple uses. It achieves thorough cleaning and efficient sterilization of the device's interior, ensuring hygienic safety for repeated use and extending the equipment's lifespan.

[0020] Furthermore, the front-end urine waste chamber is positioned directly below the inlet, while the middle-end guide channel and the rear-end overflow channel are located to the upper side of the front-end urine waste chamber, with the inlet height of the rear-end overflow channel higher than that of the middle-end guide channel. Within a single device, the kinetic energy and gravity of the fluid itself are used to achieve precise physical segmentation of the continuous water flow, without relying on electronic sensors or electric valves. By utilizing gravity and liquid level differences to construct a passive fluid pipeline, the flow separation logic of front-end interception, middle-end guidance, and rear-end overflow is automatically completed, significantly reducing equipment manufacturing costs and failure rates.

[0021] Furthermore, infrared temperature and color sensors are installed on the outer wall of the middle diversion channel, which solves the common cheating behaviors in physical examinations or drug tests, such as adding water or replacing specimens, as well as the problem that traditional barcodes are easy to fall off or become blurry in humid environments. The sensors record the initial temperature of urine when it is just excreted in real time, providing objective basis for anti-cheating judgment, effectively curbing specimen falsification, and ensuring the authenticity and legal validity of test results.

[0022] Furthermore, the urine collection funnel module, automatic diversion valve control module, vacuum collection tube connection module, and sealing and cleaning module adopt a modular, independently assembled design, with each module connected via standardized fluid interfaces. This solves the problems of traditional integrated equipment requiring complete machine replacement in case of failure, high maintenance costs, and difficulty in functional expansion. Any faulty module can be replaced individually, reducing the total lifecycle maintenance cost; hospitals can flexibly select and configure functional modules such as sensors according to their specific scenarios, adapting to different departmental budgets and needs; and it facilitates production quality control and improves assembly efficiency.

[0023] Furthermore, the urine collection funnel module is integrally injection molded from polytetrafluoroethylene or modified polypropylene material with added nano-silver ions, and the inner wall is etched with biomimetic micro-nano-level guiding grooves distributed from top to bottom. This solves the problem of urine residue adhering to the inner wall of the funnel, which leads to impaired sample integrity and difficulties in subsequent cleaning. It reduces the surface tension of urine, accelerates the collection of urine to the bottom outlet, and greatly reduces residue on the tube wall; the nano-silver ions provide a continuous antibacterial effect, further improving hygiene and safety. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the intelligent urine sample collection device of the present invention; Figure 2 This is a logic diagram of the front-end urine collection of the intelligent urine sample collection device of the present invention; Figure 3 This is a logic diagram of mid-section urine collection in the intelligent urine sample collection device of the present invention; Figure 4 This is a flowchart illustrating the sealing and cleaning module of the intelligent urine sample collection device of the present invention. Among them, 100 is the urine collection funnel module; 200 is the automatic diversion valve control module; 300 is the front urine waste liquid chamber; 301 is the first-stage buoyancy control valve; 400 is the middle section guide channel; 401 is the vacuum collection tube; 402 is the tube positioning slot; 500 is the rear overflow channel; and 600 is the rotating cleaning nozzle. Detailed Implementation

[0025] To make the objectives and advantages of the present invention clearer, the present invention will be further described below with reference to embodiments; it should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention.

[0026] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Those skilled in the art should understand that these embodiments are merely illustrative of the technical principles of the present invention and are not intended to limit the scope of protection of the present invention.

[0027] Please see Figure 1 As shown, it is a structural schematic diagram of the intelligent urine sample collection device of the present invention, comprising: The urine collection funnel module has its bottom outlet connected to the inlet of the front urine waste chamber; An automatic diversion valve control module is used to sequentially divert collected urine to a front interception channel, a middle diversion channel, and a rear overflow channel. The middle diversion channel and the rear overflow channel are respectively located on the upper side of the front urine waste chamber. The vacuum collection tube connection module includes a urine collection needle-type puncture needle and a tube body positioning slot located at the end of the middle flow channel of the automatic diversion valve control module. The tube body positioning slot is used to fix the inserted vacuum collection tube. The tail end of the urine collection needle-type puncture needle is connected to the middle flow channel, and the tip is covered with a silicone sleeve to puncture the rubber stopper of the vacuum urine collection tube when it is inserted to establish a sealed negative pressure fluid channel. The sealed cleaning module includes a drive motor, a rotating cleaning nozzle, and a sterilization unit, which is used to flush and sterilize the fluid channels inside the device after collection. The sensor assembly includes an infrared temperature sensor, a color sensor, and a control unit mounted on the outer wall of the middle flow channel. The infrared temperature sensor is used to detect the initial temperature of the urine flowing through it for anti-cheating determination.

[0028] Understandably, the urine collection funnel module, acting as the physical urine collection end, has its bottom outlet directly connected to the inlet of the automatic diversion valve control module via a fluid conduit. The automatic diversion valve control module internally features three channels of varying heights and flow resistances, achieving mechanical diversion based on the increase in liquid level and volume change caused by continuous urine injection. The middle diversion channel is rigidly connected to the vacuum collection tube connector module, utilizing the negative pressure of a clinically standard vacuum tube as the sole power source for sample extraction. After collection, a sealed cleaning module built into the top of the device or inside the channels cleans and sterilizes the fluid conduit.

[0029] Specifically, in the automatic diversion valve control module, the front urine waste chamber is a cylindrical cavity with a conical constriction structure at the top. The semi-cone angle of the conical constriction is 15° to 30°, and the minimum inner diameter is 8mm to 15mm.

[0030] To determine the semi-cone angle of the conical closure, this invention conducts a semi-cone angle parameter optimization experiment under the same environmental conditions, fabricating several conical closures with different semi-cone angles, and testing the sealing performance using a urine simulation solution. The urine simulation solution uses standard artificial urine, with the following components: urea 10g / L, sodium chloride 5g / L, dipotassium hydrogen phosphate 2.5g / L, creatinine 1g / L, and pH value 6.0±0.5.

[0031] Since the semi-cone angle of the tapered opening directly affects the guiding accuracy and sealing performance of the float during its ascent, if the semi-cone angle is too small, the float will experience high resistance to ascent, slow response, and difficulty in demolding; if the semi-cone angle is too large, the contact area between the float and the cone wall will decrease, resulting in a reduced sealing performance. The experimental results are shown in Table 1 below: Table 1. Experimental results of optimizing the semi-cone angle parameters of the tapered opening.

[0032] As shown in Table 1, when the semi-cone angle is within the range of 15° to 30°, the float sealing success rate is higher than 94%, the sealing response time is less than 1.6s, and the demolding yield is higher than 93%, demonstrating excellent overall performance. When the semi-cone angle is lower than 15°, the float's upward guiding resistance increases significantly, the sealing response time exceeds 2.8s, and the demolding yield is lower than 73%. When the semi-cone angle exceeds 30°, the contact area between the float and the cone wall decreases rapidly, and the sealing success rate drops below 82%. Therefore, the preferred range for the semi-cone angle in this invention is set to 15° to 30°.

[0033] Please see Figure 2 As shown, it is a logic diagram of the front-end urine collection of the intelligent urine sample collection device of the present invention. Specifically, a first-stage buoyancy control valve is provided inside the front-end urine waste chamber. The primary buoyancy control valve is a sphere made of closed-cell foamed polyurethane or foamed polypropylene, with a diameter 1.2 to 1.4 times the minimum inner diameter of the conical opening and a density of 0.35 to 0.55 g / cm³. When the liquid level in the cavity reaches a preset level of 10 ml to 20 ml, the float rises along the inner wall of the conical opening and embeds itself at the minimum diameter, thereby blocking the entrance of the front urine waste chamber and allowing subsequent urine to enter the middle guiding channel.

[0034] In this embodiment, a primary buoyancy control valve made of low-density foam material is placed inside the initial urine waste chamber. When the patient begins to urinate, urine flows into the waste chamber first due to gravity. When the volume of liquid in the chamber reaches 10ml to 20ml, the buoyancy generated by the liquid level exceeds the weight of the buoyancy control valve itself. The float rises and precisely embeds itself into the conical inlet at the top of the waste chamber, forming a physical blockage. At this point, the initial urine is locked inside the waste chamber, and subsequent urine, under hydraulic pressure, has nowhere to go but overflows into the middle diversion channel above and to the side.

[0035] The minimum inner diameter of the conical constriction determines the flow rate of urine in the initial stage and the sealing effect of the float. An inner diameter that is too small can easily cause blockage by flocculent matter in the urine, while an inner diameter that is too large increases the sealing surface of the float and reduces sealing reliability. In this embodiment, several conical constrictions with different minimum inner diameters but identical other parameters were fabricated to test the float sealing pass rate. The experimental results are shown in Table 2 below: Table 2. Experimental results of optimizing the minimum inner diameter parameters of the tapered opening.

[0036] As shown in Table 2, when the minimum inner diameter is within the range of 8mm to 15mm, the average flow rate is between 6.8 and 16.8 ml / s, meeting the requirements for normal urine flow rate, with a blockage probability of less than 2.1% and a float seal pass rate of over 94%. When the inner diameter is less than 8mm, the probability of blockage by flocculent matter is as high as 15.6%, seriously affecting the collection process; when the inner diameter is greater than 15mm, the float seal pass rate drops to 85%, posing a risk of leakage. Therefore, the preferred range for the minimum inner diameter in this invention is set to 8mm to 15mm.

[0037] The density of the primary buoyancy control valve determines the float's upward response speed in urine and the accuracy of the sealing fluid volume. If the density is too low, the float rises too early, resulting in insufficient initial retention; if the density is too high, the float's response is slow, leading to delayed sealing and mixing of initial urine with midstream urine. In this embodiment, the float diameter was set to 1.3 times the minimum inner diameter of the conical opening. The sealing reliability of several different float densities was tested, and the experimental results are shown in Table 3 below. Table 3 Experimental results of density parameter optimization for buoyancy control valve

[0038] Table 3 shows that when the float density is within the range of 0.35–0.55 g / cm³, the sealing reliability is higher than 95%, the liquid volume accuracy error is controlled within ±5.8%, and the buoyancy response time is less than 1.7 s. When the density is lower than 0.35 g / cm³, the float rises too early, the front-end interception deviation is as high as ±18.3%, and the sealing reliability is less than 77%. When the density is higher than 0.55 g / cm³, the float response time exceeds 2 s, and the sealing reliability drops to 86%. Therefore, the preferred range for float density in this invention is 0.35–0.55 g / cm³. By selecting closed-cell foamed polyurethane or foamed polypropylene materials, the density can be precisely controlled within this range by adjusting the foaming ratio.

[0039] Table 3 shows that when the float density is within the range of 0.35–0.55 g / cm³, the sealing reliability is higher than 95%, the liquid volume accuracy error is controlled within ±5.8%, and the buoyancy response time is less than 1.7 s. When the density is lower than 0.35 g / cm³, the float rises too early, the front-end interception deviation is as high as ±18.3%, and the sealing reliability is less than 77%. When the density is higher than 0.55 g / cm³, the float response time exceeds 2 s, and the sealing reliability drops to 86%. Therefore, the preferred range for float density in this invention is 0.35–0.55 g / cm³. By selecting closed-cell foamed polyurethane or foamed polypropylene materials, the density can be precisely controlled within this range by adjusting the foaming ratio.

[0040] In this embodiment, if the amount of urine retained in the anterior urethra is too small, the pre-existing bacterial flora in the anterior urethra will not be adequately flushed out, resulting in a high false-positive rate in midstream urine cultures; if the amount retained is too large, it may lead to insufficient midstream urine collection in patients with low urine output. The experiment used simulated urine samples containing labeled bacterial solutions. After retaining different volumes of urine, the sampling success rate was tested. The results are shown in Table 4 below. Table 4. Experimental results of front-end retention parameter optimization

[0041] As shown in Table 4, when the retention volume is within the range of 10ml to 20ml, the false positive rate of midstream urine culture is less than 3.5%, and the sampling success rate is higher than 96%. When the retention volume is 5ml, the false positive rate is as high as 12.3%, which cannot meet clinical requirements. When the retention volume exceeds 20ml, although the false positive rate continues to decrease, the sampling success rate drops to 86.5%, and some patients have insufficient urine volume. Clinical studies have shown that the normal adult urine output is usually 200-400ml, with the first 10% of the urine being the first 10%. Therefore, a retention volume of 10ml to 20ml can effectively exclude first 10ml contamination without affecting the collection volume of midstream urine. Therefore, the preferred range for the first 10ml to 20ml retention volume in this invention is set as 10ml to 20ml.

[0042] Specifically, the inlet of the middle-section flow channel is flush with the top wall of the front urine waste chamber, and its cross-section is rectangular or elliptical. The middle-section flow channel extends obliquely from the inlet to the vacuum collection tube connection module.

[0043] Understandably, this invention utilizes height differences to design fluid resistance. During structural injection molding, the inlet height of the rear overflow channel is designed to be higher than the inlet height of the middle guide channel, forming an "overflow weir." When the vacuum tube is filled with its rated capacity of urine by negative pressure, the pressure difference between the inside and outside of the vacuum tube disappears, and the middle guide channel forms a fluid lock-in resistance, preventing further fluid intake. At this point, the patient's continuous urine output causes the liquid level to rise rapidly, overflowing the overflow weir structure and safely draining into the toilet or sewer through the rear overflow channel.

[0044] Please see Figure 3 As shown, it is a logic diagram of the middle section urine collection of the intelligent urine sample collection device of the present invention. Specifically, the inlet height of the rear overflow channel is higher than the inlet height of the middle guide channel. After the vacuum collection tube completes the negative pressure extraction of the middle section of urine, the level of the subsequently discharged urine rises and is discharged to the outside of the device through the rear overflow channel.

[0045] In this embodiment, the connector module uses injection molding to create a tube positioning slot, the inner diameter of which precisely matches the standard vacuum urine collection tube commonly used in hospitals, serving as a physical guide and fixation mechanism. A urine collection needle-type puncture needle is vertically fixed at the center of the bottom of the slot, with its tail end connected to the middle drainage channel and its tip fitted with a medical-grade elastic silicone sheath. When the patient or medical staff presses the vacuum collection tube into the slot, the puncture needle pierces the silicone sheath and instantly breaks the rubber stopper of the vacuum tube. Utilizing the factory-installed negative pressure within the tube, the middle urine is completely and tightly drawn into the test tube. When the test tube is removed, the silicone sheath re-wraps the needle due to its own elasticity, preventing residual liquid leakage.

[0046] Specifically, the rotating cleaning nozzle of the sealed cleaning module is mounted on one side of the automatic diversion valve control module via a miniature ball bearing; a sealing ring is provided at the point where the rotating shaft of the nozzle passes through the top cover to prevent the cleaning fluid from leaking along the shaft to the external circuit area; The rotating nozzle has two fan-shaped nozzles with a spray angle of 60° to 90°, which rotate in conjunction with the drive motor at a speed of 200 rpm to 500 rpm.

[0047] The rotational speed and spray angle of the rotary cleaning nozzle directly affect the cleaning coverage and sterilization effect of the internal fluid channels of the device. If the speed is too low, the cleaning fluid cannot cover the dead corners of the channels; if the speed is too high, energy consumption increases and splashing occurs. If the spray angle is too small, the coverage area is insufficient; if the spray angle is too large, the impact force decreases. The experiment used a fluorescent labeling method to detect the cleaning coverage and a colony counting method to detect the number of residual colonies. The experimental results are shown in Table 5 below. Table 5. Rotary cleaning nozzle parameter optimization experiment

[0048] As shown in Table 5, when the rotation speed is between 200 and 500 rpm and the spray angle is between 60° and 90°, the cleaning coverage rate is higher than 88%, the cleaning time does not exceed 60 seconds, and the residual colony count is lower than 3.2 CFU / cm², meeting the requirement of ≤20 CFU / cm² for the surface colony count of endoscopic instruments in the "Technical Specifications for Disinfection in Medical Institutions" (WS / T 367-2012). When the rotation speed is lower than 200 rpm or the spray angle is less than 60°, the cleaning coverage rate is only 62%, and the residual colony count is as high as 15.6 CFU / cm². When the rotation speed exceeds 500 rpm, the improvement in cleaning coverage rate is not significant (only an increase of 0.3%), but the motor power consumption increases by about 40%, and the splashing generated by high-speed rotation increases the risk of leakage of cleaning fluid along the shaft. Therefore, the preferred rotation speed range of this invention is set to 200–500 rpm, and the preferred spray angle range is set to 60°–90°.

[0049] Specifically, the cleaning solution sprayed by the rotating cleaning nozzle is sterile saline or a disinfectant containing povidone-iodine. After cleaning, the waste liquid is discharged to the outside of the device through the overflow channel in the rear section and the drain outlet in the urine waste liquid chamber in the front section.

[0050] Specifically, the anti-cheating determination steps of the sensor assembly include: The control unit compares the initial temperature of the urine detected by the infrared temperature sensor with the normal temperature range of human urine; when the detected initial temperature of the urine exceeds the normal temperature range of human urine, it is determined to be an abnormal sample.

[0051] Please see Figure 4 As shown, the tail end of the urine collection needle is rigidly connected to the middle channel, and the tip is covered with a medical elastic silicone sheath. When the vacuum urine collection tube is inserted along the positioning groove of the tube body, the needle pierces the silicone sheath and breaks the rubber stopper of the vacuum collection tube to establish a sealed negative pressure fluid channel from the middle channel to the inside of the vacuum collection tube. When the vacuum collection tube is pulled out, the silicone sheath re-wraps the needle tip with its own elasticity.

[0052] Specifically, the urine collection funnel module is integrally injection molded using polytetrafluoroethylene or modified polypropylene material with added nano-silver ions; the inner wall surface of the urine collection funnel module is etched with biomimetic micro-nano-level guiding groove textures distributed from top to bottom to reduce the surface tension of urine, accelerate urine collection and reduce tube wall residue.

[0053] In this embodiment of the invention, the medical-grade antibacterial hydrophobic polymer material used is polytetrafluoroethylene or modified PP material with added nano-silver ions, integrally injection molded. Microstructurally, the inner wall surface of the funnel is processed using mold etching technology to create micro- and nano-scale grooves resembling the surface of a lotus leaf, distributed from top to bottom. This physically hydrophobic texture, combined with the antibacterial material, breaks the surface tension of urine, accelerating its convergence to the bottom outlet, greatly reducing urine residue on the tube wall, ensuring sample integrity and ease of subsequent cleaning.

[0054] Example 1

[0055] The intelligent urine sample collection device is manufactured according to the technical solution of this invention. The key parameters are selected from the median values ​​of their preferred ranges: a conical opening with a semi-cone angle of 22.5° and a minimum inner diameter of 11.5 mm; the first-stage buoyancy control valve uses a closed-cell foamed polyurethane sphere with a diameter 1.3 times the minimum inner diameter (approximately 14.95 mm) and a density of 0.45 g / cm³; the initial urine retention volume is preset to 15 ml; the rotating cleaning nozzle has two fan-shaped nozzles with a spray angle of 75° and a drive motor speed of 350 rpm. The urine collection funnel module is integrally injection molded from modified polypropylene material with added nano-silver ions, and the inner wall is etched with biomimetic micro / nano-level guiding grooves.

[0056] Performance test results: Float ball blocking success rate 98.5%, blocking response time 1.18s; Midstream urine culture false positive rate 2.1%, sampling success rate 98.5%; Cleaning coverage 95.8%, residual colony count 1.5 CFU / cm²; Infrared temperature sensor detects urine temperature in the range of 35.0~37.5℃, exceeding this range is considered abnormal, anti-cheating accuracy rate 99.2%.

[0057] Example 2 The intelligent urine sample collection device is manufactured according to the technical solution of the present invention. The key parameters are selected from the lower limit of the preferred range: a conical opening with a semi-cone angle of 15° and a minimum inner diameter of 8 mm; the first-stage buoyancy control valve uses a closed-cell foamed polypropylene sphere with a diameter 1.2 times the minimum inner diameter (approximately 9.6 mm) and a density of 0.35 g / cm³; the initial urine retention volume is preset to 10 ml; the rotating cleaning nozzle has a spray angle of 60° and a drive motor speed of 200 rpm. The remaining structure is the same as in Example 1.

[0058] Performance test results: float plugging success rate 95.6%, plugging response time 1.42s; midstream urine culture false positive rate 3.5%, sampling success rate 96.8%; cleaning coverage 88.5%, residual colony count 3.2 CFU / cm²; anti-cheating judgment accuracy 98.8%. This embodiment is suitable for application scenarios with relatively low requirements for midstream urine purity and small device size.

[0059] Example 3 The intelligent urine sample collection device is manufactured according to the technical solution of the present invention. The key parameters are set to the upper limit of the preferred range: a conical opening with a semi-cone angle of 30° and a minimum inner diameter of 15mm; the first-stage buoyancy control valve uses a closed-cell foamed polyurethane sphere with a diameter 1.4 times the minimum inner diameter (approximately 21mm) and a density of 0.55g / cm³; the initial urine retention volume is preset to 20ml; the rotating cleaning nozzle has a spray angle of 90° and a drive motor speed of 500rpm. The remaining structure is the same as in Example 1.

[0060] Performance test results: float plugging success rate 94.2%, plugging response time 1.56s; midstream urine culture false positive rate 1.8%, sampling success rate 97.2%; cleaning coverage 98.1%, residual colony count 0.5 CFU / cm²; anti-cheating judgment accuracy 99.0%. This embodiment is suitable for special testing scenarios (such as toxicology testing, forensic identification) where the purity and cleaning effect of midstream urine are extremely important.

[0061] To illustrate the technical advantages of the present invention, the following comparative examples were set up for comparative testing. Each comparative example was tested under the same environmental conditions as Example 1.

[0062] Comparative Example 1 In this comparative study, patients collected their own urine using a standard wide-mouth urine cup, and nurses then used a pipette to transfer the urine into a test tube.

[0063] Test results: The false positive rate of midstream urine culture was 18.5%, the cross-contamination rate of samples was 25.3%, the contamination rate from contact with healthcare workers was 35.2%, the odor diffusion rate during collection was 100%, and the barcode detachment rate due to moisture was 8.5%. This method cannot distinguish between the early, middle, and late stages of urine, and the entire process is open, resulting in an extremely high risk of contamination.

[0064] Comparative Example 2 In this comparative study, using the existing segmented urine collection device, the patient needs to manually press the valve to switch to the mid-stream urine channel.

[0065] Test results: The false positive rate of midstream urine culture was 8.6%, the valve switching error rate was 22.5%, the sampling success rate was 75.8% due to patients' subjective judgment of the initial urine volume, and there was no automatic cleaning function, resulting in a cross-contamination rate of 12.3% after repeated use. This device relies on manual operation by the patient, has a low error tolerance, and lacks a cleaning function.

[0066] Comparative Example 3 In this comparative example, the device structure of the present invention is adopted, but the key parameters are all taken as values ​​outside the preferred range: the conical opening half cone angle is 10°, the minimum inner diameter is 5mm, the buoyancy control valve density is 0.25g / cm³, the initial urine retention volume is 5ml, the rotation speed of the rotating cleaning nozzle is 100rpm, and the spray angle is 45°.

[0067] Test results: Float occlusion success rate 68.3%, occlusion response time 2.85s; midstream urine culture false positive rate 12.3%, sampling success rate 85.6%; cleaning coverage 62.3%, residual colony count 15.6 CFU / cm². This comparative example demonstrates that when parameters exceed the optimal range, all performance indicators of the device significantly decrease, failing to meet clinical requirements.

[0068] The core performance indicators of the above embodiments and comparative examples are summarized in Table 6 below: Table 6. Overall performance comparison between the examples and comparative examples

[0069] As shown in Table 6, the false positive rate of midstream urine culture in Examples 1-3 of the present invention was 1.8%-3.5%, the sampling success rate was 94.2%-98.5%, the washing coverage rate was 88.5%-98.1%, and the residual colony count was 0.5-3.2 CFU / cm². All of these core indicators were significantly better than those of the control group.

[0070] Compared with the traditional wide-mouth urine cup of Comparative Example 1, the false positive rate of midstream urine culture of the present invention is reduced by 82% to 90%, and the cross-contamination rate is reduced from 25.3% to below 0.5%. It realizes a fully closed negative pressure fluid channel from urination to specimen collection, and completely eliminates the risk of spillage and infection caused by secondary pouring.

[0071] Compared with the existing segmented urine collection device in Comparative Example 2, the present invention uses a buoyancy control valve to achieve automatic mechanical diversion, eliminating the need for manual operation by the patient. The sampling success rate is increased from 75.8% to 94.2%–98.5%. At the same time, it adds sealing cleaning and anti-cheating functions, solving the technical defects of existing devices such as low fault tolerance, lack of cleaning and anti-counterfeiting.

[0072] Compared with the device in Comparative Example 3 whose parameters exceeded the preferred range, the float sealing success rate of the embodiment of the present invention increased from 68.3% to 94.2% to 98.5%, and the cleaning coverage rate increased from 62.3% to 88.5% to 98.1%, which fully verifies the necessity and rationality of the preferred parameter range defined by the present invention.

[0073] The technical solution of the present invention has been described above with reference to the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will all fall within the scope of protection of the present invention.

Claims

1. A smart urine sample collection device, characterized in that, include: The urine collection funnel module has its bottom outlet connected to the inlet of the front urine waste chamber; An automatic diversion valve control module is used to sequentially divert collected urine to a front interception channel, a middle diversion channel, and a rear overflow channel. The middle diversion channel and the rear overflow channel are respectively located on the upper side of the front urine waste chamber. The vacuum collection tube connection module includes a urine collection needle-type puncture needle and a tube body positioning slot located at the end of the middle flow channel of the automatic diversion valve control module. The tube body positioning slot is used to fix the inserted vacuum collection tube. The tail end of the urine collection needle-type puncture needle is connected to the middle flow channel, and the tip is covered with a silicone sleeve to puncture the rubber stopper of the vacuum urine collection tube when it is inserted to establish a sealed negative pressure fluid channel. The sealed cleaning module includes a drive motor, a rotating cleaning nozzle, and a sterilization unit, which is used to flush and sterilize the fluid channels inside the device after collection. The sensor assembly includes an infrared temperature sensor, a color sensor, and a control unit mounted on the outer wall of the middle flow channel. The infrared temperature sensor is used to detect the initial temperature of the urine flowing through it for anti-cheating determination.

2. The intelligent urine sample collection device according to claim 1, characterized in that, In the automatic diversion valve control module, the front urine waste liquid chamber is a cylindrical cavity with a conical constriction structure at the top. The semi-cone angle of the conical constriction is 15° to 30°, and the minimum inner diameter is 8mm to 15mm.

3. The intelligent urine sample collection device according to claim 2, characterized in that, The front section of the urine waste chamber is equipped with a first-stage buoyancy control valve. The primary buoyancy control valve is a sphere made of closed-cell foamed polyurethane or foamed polypropylene, with a diameter 1.2 to 1.4 times the minimum inner diameter of the conical opening and a density of 0.35 to 0.55 g / cm³. When the liquid level in the cavity reaches a preset level of 10 ml to 20 ml, the float rises along the inner wall of the conical opening and embeds itself at the minimum diameter, thereby blocking the entrance of the front urine waste chamber and allowing subsequent urine to enter the middle guiding channel.

4. The intelligent urine sample collection device according to claim 3, characterized in that, The inlet of the middle-section guide channel is flush with the top wall of the front urine waste chamber, and its channel cross-section is rectangular or elliptical. The middle-section guide channel extends obliquely from the inlet to the vacuum collection tube connection module.

5. The intelligent urine sample collection device according to claim 4, characterized in that, The inlet height of the rear overflow channel is higher than the inlet height of the middle guide channel; After the vacuum collection tube completes the negative pressure extraction of the middle section of urine, the level of the subsequently discharged urine rises and is discharged to the outside of the device through the rear overflow channel.

6. The intelligent urine sample collection device according to claim 5, characterized in that, The rotating cleaning nozzle of the sealed cleaning module is mounted on one side of the automatic diversion valve control module via a miniature ball bearing; a sealing ring is provided at the point where the rotating shaft of the nozzle passes through the top cover to prevent the cleaning fluid from leaking along the rotating shaft to the external circuit area. The rotating nozzle has two fan-shaped nozzles with a spray angle of 60° to 90°, which rotate in conjunction with the drive motor at a speed of 200 rpm to 500 rpm.

7. The intelligent urine sample collection device according to claim 6, characterized in that, The cleaning solution sprayed by the rotary cleaning nozzle is sterile saline or a disinfectant containing povidone-iodine. After cleaning, the waste liquid is discharged to the outside of the device through the overflow channel in the rear section and the drain outlet in the urine waste liquid chamber in the front section.

8. The intelligent urine sample collection device according to claim 7, characterized in that, The anti-cheating determination steps of the sensor assembly include: The control unit compares the initial temperature of the urine detected by the infrared temperature sensor with the normal temperature range of human urine; when the detected initial temperature of the urine exceeds the normal temperature range of human urine, it is determined to be an abnormal sample.

9. The intelligent urine sample collection device according to claim 8, characterized in that, The tail end of the urine collection needle is rigidly connected to the middle channel, and the tip is covered with a medical elastic silicone sheath. When the vacuum urine collection tube is inserted along the positioning groove of the tube body, the needle pierces the silicone sheath and the rubber stopper of the vacuum collection tube to establish a sealed negative pressure fluid channel from the middle channel to the inside of the vacuum collection tube. When the vacuum collection tube is pulled out, the silicone sheath re-wraps the needle tip with its own elasticity.

10. The intelligent urine sample collection device according to claim 9, characterized in that, The urine collection funnel module is integrally injection molded from polytetrafluoroethylene or modified polypropylene material with added nano silver ions; the inner wall surface of the urine collection funnel module is etched with biomimetic micro-nano-level guiding groove textures distributed from top to bottom to reduce the surface tension of urine, accelerate urine collection and reduce tube wall residue.

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