A neonatal urine collection and storage assembly

Abstract

The present application relates to the technical field of medical devices, in particular to a newborn urine collection and freezing assembly, which comprises a collection cover, a flow guide pipe, a freezing tube, a fixing seat and a negative pressure cavity, the collection cover, the flow guide pipe and the freezing tube are in communication with each other; a piston is slidably arranged in the negative pressure cavity; the freezing tube is threadedly connected to the fixing seat, the negative pressure cavity is fixedly connected to the outer wall of the fixing seat, and a transmission mechanism for driving the piston to move is arranged on the fixing seat; when the freezing tube is screwed into the fixing seat, the transmission mechanism drives the piston to move, so that negative pressure is generated in the negative pressure cavity. The assembly further comprises a switching valve for connecting the negative pressure cavity and the freezing tube, the switching valve comprises an open state and a closed state; liquid pressure drives the switching valve to switch to the open state, and the negative pressure generated by the negative pressure cavity transports urine into the freezing tube. The present application is used for reducing the operation difficulty and labor intensity of medical staff and improving the convenience and success rate of newborn urine collection.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a neonatal urine collection and cryopreservation kit. Background Technology

[0002] Urine testing is one of the most routine examinations in neonatal and pediatric clinical practice. It is of great clinical significance for determining whether a newborn has a urinary tract infection, hematuria, or proteinuria, assessing renal function, and detecting potential metabolic diseases early. Accurate and timely acquisition of high-quality urine samples is a fundamental prerequisite for ensuring the reliability of subsequent test results. However, given the physiological characteristics of newborns, urine collection has long faced many challenges. On the one hand, newborns' urination is irregular, with small amounts of urine per urination, and they cannot control their urination, making it difficult to accurately determine the collection time. On the other hand, existing clinically used non-invasive urine collection methods, mainly including adhesive urine bags, clean collection methods, and urine pad collection methods, all have their own limitations and operational difficulties.

[0003] While the clean collection method is considered a low-risk approach for contamination in some clinical guidelines, its success rate in actual neonatal practice is low. Adhesive-backed urine collection bags are currently the most widely used collection tool in neonatal wards. These bags are attached to the newborn's genitals using pressure-sensitive adhesive. However, this method relies heavily on external adhesion, which is not adaptable to the newborn's movements and can easily shift or fall off after crying or limb movement. Furthermore, prolonged contact with the skin during urination can cause redness or allergic reactions.

[0004] Furthermore, when transferring urine samples from the collection bag to the cryovial, it is usually necessary to first remove the collection bag and then separate the sample using tools such as a pipette or syringe. This open operation process not only easily causes urine leakage and sample residue, but also increases the risk of sample contamination from the outside world, thus affecting the accuracy of the test results. Repeated collection due to leakage, loosening, or insufficient sample volume is quite common.

[0005] Therefore, this invention proposes a neonatal urine collection and cryopreservation assembly, which is compact in structure, easy to operate, and can automatically collect and store urine. Summary of the Invention

[0006] To address the aforementioned issues, this invention provides a neonatal urine collection and cryopreservation kit, which reduces the operational difficulty and labor intensity for medical personnel, and improves the convenience and success rate of neonatal urine collection.

[0007] To achieve the above objectives, the technical solution of the present invention is as follows: A neonatal urine collection and cryopreservation assembly includes a collection cover, a guide tube, a cryopreservation tube, a fixing base, and a negative pressure chamber. The collection cover, the guide tube, and the cryopreservation tube are all interconnected. A piston is slidably fitted inside the negative pressure chamber. The cryopreservation tube is detachably connected to the fixing base, and the negative pressure chamber is fixedly connected to the outer wall of the fixing base. The fixing base is provided with a transmission mechanism for driving the piston to move. When the cryopreservation tube is screwed into the fixing base, the transmission mechanism drives the piston to move, thereby generating negative pressure inside the negative pressure chamber.

[0008] It also includes a switching valve for connecting the negative pressure chamber and the cryopreservation tube. The switching valve has an open state and a closed state. When the switching valve is closed, it blocks the fluid connection. When urine enters the collection hood and generates liquid pressure, the liquid pressure causes the switching valve to switch to the open state, and the negative pressure generated by the negative pressure chamber delivers the urine to the cryopreservation tube.

[0009] The technical principles of the above solution are as follows:

[0010] By screwing the cryopreservation tube into the mounting base, a transmission mechanism drives a piston to move within the negative pressure chamber, pre-establishing a negative pressure. The switching valve is initially closed to maintain the negative pressure within the chamber. When the newborn urinates, urine enters the collection hood and generates liquid pressure, which triggers the switching valve to open. At this point, the negative pressure within the chamber draws the urine in and delivers it into the cryopreservation tube, completing the process from collection to tube insertion. The entire process uses the cryopreservation tube installation as its energy source and the urine's own pressure as its trigger signal, achieving efficient collection of newborn urine that is simple to operate and prevents contamination.

[0011] The above approach has the following beneficial effects:

[0012] 1. This solution establishes negative pressure in the negative pressure chamber beforehand by screwing in the cryopreservation tube, and uses the urine's own liquid pressure as the trigger signal for the switching valve, enabling immediate urine collection upon urination. When medical staff screw the cryopreservation tube into the fixing seat, the transmission mechanism drives the piston to generate negative pressure, pre-storing energy inside the device. This design not only simplifies the operation process and reduces the difficulty and labor intensity for medical staff, but also improves the convenience and success rate of neonatal urine collection.

[0013] 2. This method sequentially and sealed the collection hood, drainage tube, negative pressure chamber, switching valve, and cryopreservation tube. Urine enters the cryopreservation tube under negative pressure, reducing additional transfer operations. The switching valve remains closed when not urinating to maintain the seal of the negative pressure chamber and prevent urine backflow or evaporation. The closed flow path ensures sample integrity, reduces the risk of cross-contamination, and guarantees the accuracy of subsequent test results.

[0014] 3. This solution completes negative pressure energy storage by tightening the cryopreservation tube, and the sampling is triggered during the urination process, reducing the time required for continuous monitoring or additional operations. The threaded fit between the cryopreservation tube and the fixing base, as well as the transmission mechanism, are integrated into one component, making the whole unit compact and lightweight. It can be fixed to the newborn, reducing the difficulty of operation for nursing staff.

[0015] Furthermore, the transmission mechanism includes a first rack that slides with the fixed seat, and the first rack meshes with an external gear ring; the external gear ring is rotatably connected to the inner wall of the fixed seat, and the external gear ring is detachably connected to the cryopreservation tube; a connecting rod is fixedly connected to the piston, and a first magnetic block is fixedly connected to the end of the connecting rod away from the piston; the first magnetic block is magnetically engaged with a second magnetic block, and the second magnetic block is fixedly connected to the end of the first rack away from the cryopreservation tube.

[0016] Beneficial effects: The screw-driven external gear ring, which in turn drives the first rack in linear motion, converts the screwing-in action of the cryopreservation tube into piston displacement. Non-contact power transmission via magnetic coupling avoids mechanical wear and seal failure, ensuring stable and reliable negative pressure generation and improving the device's durability and sampling accuracy.

[0017] Furthermore, the fixed base is also provided with a locking mechanism for locking the piston sliding; the locking mechanism includes a fixed plate fixedly connected to the outer wall of the fixed base, a transmission block slidably fitted on the inner side wall of the fixed plate, and a stop rod fixedly connected to the side of the transmission block away from the fixed base; the end of the stop rod away from the transmission block is fixedly connected to a connecting rod, and a rocker arm is hinged to the bottom of the fixed plate; a groove is opened at the bottom of the transmission block, and a locking rod is rotatably connected to the end of the rocker arm away from the fixed plate; the locking rod is located in the groove and slidably fitted with the groove; a spring is sleeved on the outer wall of the stop rod, and the two ends of the spring abut against the transmission block and the inner wall of the fixed plate, respectively.

[0018] Beneficial effects: By linking the lever with the irregular groove, the transmission block is automatically engaged when the piston moves to the preset position, thus locking the piston position. This design prevents the piston from retracting due to vibration or tilting of the negative pressure chamber, ensuring stable maintenance of the negative pressure state, avoiding urine backflow or sampling failure, and improving the safety and reliability of the device.

[0019] Furthermore, the switching valve includes a valve body and an elastic diaphragm. The protruding part of the elastic diaphragm abuts against the inner wall of the valve body, and both ends of the elastic diaphragm are fixedly connected to the inner wall of the valve body. The side of the negative pressure chamber away from the connecting rod is connected to an input pipe and an output pipe. A one-way valve is also provided on the communication path between the input pipe and the output pipe and the negative pressure chamber. The end of the output pipe away from the negative pressure chamber is connected to the cryopreservation tube. One side of the valve body is connected to the guide pipe, and the other side of the valve body is connected to the end of the input pipe away from the negative pressure chamber. The switching valve is also provided with a release mechanism for releasing the locking rod limit.

[0020] Beneficial effects: The automatic storage and release of negative pressure is achieved through the linkage of the elastic diaphragm and the release mechanism. The one-way valve prevents urine backflow, ensuring unidirectional sample flow. The switching valve works in conjunction with the negative pressure chamber to automatically open the flow path during urination, reducing manual intervention, simplifying operation, avoiding spillage and contamination, and improving collection success rate and sample quality.

[0021] Furthermore, the release mechanism includes a second rack fixedly connected to the inner wall of the elastic diaphragm, with a wide gear meshing at the end of the second rack away from the elastic diaphragm; the wide gear is rotatably engaged with the inner wall of the fixed seat, and a third rack is meshed with the wide gear; the end of the third rack away from the wide gear contacts the transmission block, and the third rack is slidably engaged with both the fixed plate and the fixed seat.

[0022] Beneficial effects: The driving force of the elastic diaphragm is converted into the displacement of the transmission block through rack and pinion transmission, realizing the engagement and disengagement of the locking rod with the irregular groove. This mechanical linkage requires no additional power, ensuring that the piston is firmly locked during negative pressure storage and unlocked when urination is triggered. The action is reliable and responsive, simplifying the operation process and improving the level of automation in urine collection.

[0023] Furthermore, it also includes a refrigeration mechanism for providing cooling to the cryopreservation tube, the refrigeration mechanism including a phase change cold storage ring and an activation needle; the phase change cold storage ring is located at the connection between the fixed base and the cryopreservation tube, a sealing membrane is provided on the outer side of the phase change cold storage ring, and the activation needle is slidably fitted on the inner wall of the fixed base; the tip of the activation needle faces the sealing membrane, and the side of the activation needle away from the sealing membrane contacts the third rack.

[0024] Beneficial effects: The movement of the third rack triggers the needle to puncture the sealing membrane, initiating the phase change cold storage ring for immediate cooling. This design links cooling with valve switching, achieving automatic low-temperature sealing upon completion of sampling. This reduces sample deterioration caused by delays in manual operation, ensuring that the cryopreservation tubes reach a stable low-temperature state promptly after collection, thus protecting sample activity and detection accuracy.

[0025] Furthermore, the fixing base is also hinged with several elastic clips, which are distributed circumferentially on the outside of the cryopreservation tube; the fixing base is provided with a locking mechanism for locking the elastic clips.

[0026] Beneficial effects: The circumferentially distributed elastic clips provide clamping force, securing cryovials of different sizes. Combined with a locking mechanism, this ensures the tubes do not loosen or fall off during sampling. This design prevents sample leakage or contamination, improves equipment versatility and operational safety, and guarantees sample integrity.

[0027] Furthermore, the locking mechanism includes a locking nut that is threaded into the outer wall of the fixed seat, and inclined blocks are fixedly connected to the side of the elastic clip away from the fixed seat. An inclined groove is opened inside the locking nut to contact the inclined blocks.

[0028] Beneficial effects: When the locking nut is tightened, the inclined groove pushes the inclined block to contract radially, driving the elastic clamp to hold the cryopreservation tube tightly. This structure converts axial rotational force into radial clamping force, achieving rapid locking and releasing. It not only adapts to different tube diameters, but also provides uniform and stable clamping force, preventing samples from slipping or leaking during transportation, and is convenient and reliable to operate.

[0029] Furthermore, the side of the collection hood away from the guide tube is provided with several sealing protrusions; a universal joint is also provided at the connection between the collection hood and the guide tube.

[0030] Beneficial effects: The sealing protrusion enhances the fit between the sampling cover and the skin, effectively preventing leakage and ensuring stable negative pressure during sampling. The universal joint provides multi-degree-of-freedom adjustment at the connection point, flexibly adapting to different body positions and contours, reducing operational difficulty, improving wearing comfort and sampling efficiency, and ensuring sample collection quality.

[0031] Furthermore, an excess collection chamber can be detachably connected to the outer wall of the fixed base, and the excess collection chamber is connected to the switching valve.

[0032] Beneficial effects: The addition of an excess collection chamber allows for the temporary storage of excess urine beyond the cryovial capacity, preventing sample spillage and contamination, and avoiding seal failure due to overfilling. This chamber is connected to a switching valve and can be independently disassembled for testing or discarded after collection, ensuring sufficient sample volume, preventing the risk of overfilling, and improving sampling reliability and sample integrity. Attached Figure Description

[0033] Figure 1 This is an isometric view of the neonatal urine collection, tube freezing, and storage assembly of the present invention.

[0034] Figure 2 For the present invention Figure 1 The side sectional view in the middle.

[0035] Figure 3 For the present invention Figure 1 Axonometric view of the cryopreservation tube.

[0036] Figure 4 For the present invention Figure 2 Axonometric view of the switching valve.

[0037] Figure 5 For the present invention Figure 4 The front sectional view in the image.

[0038] Figure 6 For the present invention Figure 2 Axonometric drawing of the locking mechanism from below.

[0039] Figure 7 For the present invention Figure 1 Axonometric view of a medium-elastic clamping piece.

[0040] Figure 8 For the present invention Figure 6 Front view of the transmission block.

[0041] The reference numerals in the accompanying drawings of the instruction manual include: 1. Collection cover; 2. Guide tube; 3. Cryopreservation tube; 4. Fixing base; 5. Negative pressure chamber; 6. Piston; 7. Switching valve; 8. First rack; 9. External gear ring; 10. Fixing plate; 11. Transmission block; 12. Push rod; 13. Swing rod; 14. Elastic diaphragm; 15. Second rack; 16. Wide gear; 17. Third rack; 18. Spring; 19. Elastic clamp; 20. Locking nut; 21. Inclined block; 22. Excess collection chamber. Detailed Implementation

[0042] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0043] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0045] The following detailed description illustrates the specific implementation method:

[0046] Example 1:

[0047] As attached Figure 1 and Figure 2As shown: A neonatal urine collection and cryopreservation assembly includes a collection cover 1, a guide tube 2, a cryopreservation tube 3, a fixing base 4, and a negative pressure chamber 5. The collection cover 1, the guide tube 2, and the cryopreservation tube 3 are all interconnected. A piston 6 is slidably fitted inside the negative pressure chamber 5. The cryopreservation tube 3 is threaded onto the fixing base 4. The negative pressure chamber 5 is fixedly connected to the outer wall of the fixing base 4 by screws. The fixing base 4 is provided with a transmission mechanism for moving the piston 6. When the cryopreservation tube 3 is screwed into the fixing base 4, the transmission mechanism drives the piston 6 to move, causing negative pressure to be generated inside the negative pressure chamber 5.

[0048] In this embodiment, both the collection cover 1 and the drainage tube 2 are made of non-toxic, odorless, and non-cytotoxic flexible polymer materials such as medical-grade silicone or thermoplastic elastomer (TPE), ensuring softness and comfort when in contact with the newborn's perineal skin, without causing pressure marks or allergic reactions. The overall shape of the component is thin and low-profile. Combined with the flexible bending characteristics of the drainage tube 2, it can be completely accommodated inside when the newborn is wearing a diaper or swaddle, without causing local pressure or friction. The length and flexibility of the drainage tube 2 allow the fixing seat 4 to be placed beside the bed or pasted to the outside of the diaper without affecting daily care operations.

[0049] This embodiment also includes a switching valve 7 for connecting the negative pressure chamber 5 and the cryopreservation tube 3. The switching valve 7 has an open state and a closed state. When the switching valve 7 is in the closed state, it blocks the fluid communication. When urine enters the collection hood 1 and generates liquid pressure, the liquid pressure causes the switching valve 7 to switch to the open state, and the negative pressure generated by the negative pressure chamber 5 delivers the urine into the cryopreservation tube 3.

[0050] The transmission mechanism includes a first rack 8 that slides with the fixed base 4 (e.g., Figure 2 As shown), the first rack 8 meshes with the external gear ring 9 (as shown). Figure 3 (As shown); the first rack 8 is in the shape of a "￢", with the teeth located at the horizontal end of the first rack 8; the outer gear ring 9 is rotatably connected to the inner wall of the fixed base 4, and the outer gear ring 9 is detachably engaged with the cryopreservation tube 3; in this embodiment, the engagement method is to add a locking block to the inner wall of the outer gear ring 9, and to open a locking groove on the cryopreservation tube 3 corresponding to the locking block, so that the cryopreservation tube 3 can drive the outer gear ring 9 to rotate when it rotates; a connecting rod is fixedly connected to the piston 6 by screws, and a first magnetic block is fixedly connected to the end of the connecting rod away from the piston 6 by screws, the first magnetic block is magnetically engaged with a second magnetic block, and the second magnetic block is fixedly connected to the end of the first rack 8 away from the cryopreservation tube 3 by screws.

[0051] Specifically, when medical staff screw the cryopreservation tube 3 into the fixing base 4, the groove on the outer wall of the cryopreservation tube 3 engages with the locking block on the inner wall of the outer gear ring 9, allowing the cryopreservation tube 3 to drive the outer gear ring 9 to rotate synchronously. The outer gear ring 9 meshes with the teeth at the horizontal end of the first gear ring 8, so the rotation of the outer gear ring 9 drives the first gear ring 8 to slide axially along the fixing base 4. A second magnetic block is fixed at the end of the first gear ring 8 away from the cryopreservation tube 3, and the second magnetic block and the first magnetic block at the end of the connecting rod achieve transmission through magnetic cooperation. When the first gear ring 8 slides, it drives the connecting rod and piston 6 to move linearly within the negative pressure chamber 5 through magnetic force. As the piston 6 moves into the negative pressure chamber 5, the volume of the negative pressure chamber 5 gradually increases, the internal air pressure decreases, and a stable negative pressure environment is formed. This negative pressure is transmitted to the switching valve 7 through the guide tube 2, providing power for the aspiration of urine samples.

[0052] In existing technologies, establishing negative pressure usually requires additional operations or the addition of an external negative pressure source, making the operation more cumbersome or increasing costs. In this embodiment, the screwing motion of the cryopreservation tube 3 is converted into the linear motion of the piston 6, generating negative pressure while fixing the cryopreservation tube 3; the entire transmission chain is compact and reliable, realizing the linkage function of tightening and storing energy.

[0053] Combination Figure 6 As shown, the fixed base 4 is also equipped with a locking mechanism for locking the sliding of the piston 6; the locking mechanism includes a fixed plate 10 fixedly connected to the outer wall of the fixed base 4 by screws, a transmission block 11 slidably fitted on the inner side wall of the fixed plate 10, and a stop rod 12 fixedly connected to the side of the transmission block 11 away from the fixed base 4 by screws; the end of the stop rod 12 away from the transmission block 11 is fixedly connected to the connecting rod by screws, and a swing rod 13 is also hinged to the bottom of the fixed plate 10. The bottom of the transmission block 11 has a shaped groove, and a locking rod is rotatably connected to the end of the swing rod 13 away from the fixed plate 10. The locking rod is located in the shaped groove and slidably fitted with the shaped groove; a spring 18 is sleeved on the outer wall of the stop rod 12, and the two ends of the spring 18 abut against the transmission block 11 and the inner wall of the fixed plate 10, respectively. Figure 8 As shown, in this embodiment, the irregular groove is roughly heart-shaped, and the upper edge of the bottom irregular groove is inclined, which makes the locking rod slide through the left irregular groove when it slides upward at the bottom of the irregular groove; the end point of the top irregular groove of the heart shape is offset to the left, which makes the locking rod slide through the right irregular groove when it slides upward at the top of the irregular groove; when the locking rod is located in the top or bottom irregular groove of the heart shape, it can engage and lock the transmission block 11.

[0054] Specifically, before sampling begins, the collection cover 1 is first placed against the perineum of the newborn, and the fixing seat 4 is fixed to the hospital bed, crib, or specific support. The piston 6 is positioned on the side of the negative pressure chamber 5 near the fixing seat 4, and the abutment rod 12 and transmission block 11 are in their initial positions within the fixing plate 10. At this time, the locking rod is located in the irregular groove at the bottom of the irregular groove (heart-shaped), engaging with the groove wall to lock the transmission block 11 in a fixed position. The spring 18 on the outer wall of the abutment rod 12 is in its natural state, providing a restoring force for subsequent movements.

[0055] When the transmission mechanism is activated (e.g., the cryopreservation tube 3 is screwed in, causing the piston 6 to move), the connecting rod slides away from the fixed seat 4 along with the piston 6, causing the abutment rod 12 and the transmission block 11 to move linearly along the inner wall of the fixed plate 10. The movement of the transmission block 11 causes the irregular groove to move synchronously, and because the swing rod 13 is hinged to the fixed plate 10, the swing rod 13 will swing, causing the locking rod to begin to slide in the irregular groove. Since the irregular groove is heart-shaped and its bottom is inclined, the locking rod will slide across the left side of the groove wall when it slides. At this time, the locking rod is not engaged in the end of the irregular groove, and the transmission block 11 can continue to move. The piston 6 completes the negative pressure establishment process. After the establishment is completed, the locking rod finally slides into the end of the irregular groove (e.g., Figure 8 As shown at the top), under the pressure of spring 18, the locking lever eventually gets stuck in the irregular groove at the top.

[0056] After the locking rod is engaged in the top of the irregular groove, it interferes with the groove wall, locking the position of the transmission block 11, thereby fixing the position of the piston 6 and preventing it from retracting due to external vibration or internal pressure changes; at this time, the negative pressure chamber 5 maintains a stable negative pressure state.

[0057] To unlock, the locking lever can be disengaged from its top end via subsequent operations. The restoring force of spring 18 pushes the transmission block 11 and the stop rod 12 back, causing piston 6 to reset and unlocking the device. This embodiment utilizes the heart-shaped groove's alignment with the locking lever's trajectory to achieve a tightening-and-lock control mode, ensuring stable negative pressure storage. The locking mechanism operates smoothly and without impact, producing low vibration and noise, and will not startle or irritate the newborn.

[0058] Combination Figure 4 and Figure 5As shown, the switching valve 7 includes a valve body and an elastic diaphragm 14. The protruding part of the elastic diaphragm 14 abuts against the inner wall of the valve body, and both ends of the elastic diaphragm 14 are bonded to the inner wall of the valve body. The elastic diaphragm 14 is made of elastic material, and in the initial state, the protruding part of the elastic diaphragm 14 always abuts against the inner wall of the valve body. The side of the negative pressure chamber 5 away from the connecting rod is connected to an input pipe and an output pipe. A one-way valve is also provided on the connection path between the input pipe and the output pipe and the negative pressure chamber 5. The one-way valve guides the flow of fluid, so that the fluid flows in from the input pipe and then flows out through the output pipe. The end of the output pipe away from the negative pressure chamber 5 is connected to the cryopreservation tube 3. One side of the valve body is connected to the guide pipe 2, and the other side of the valve body is connected to the end of the input pipe away from the negative pressure chamber 5. The switching valve 7 is also provided with a release mechanism for releasing the locking rod limit.

[0059] The release mechanism includes a second rack 15 bonded to the inner wall of the elastic diaphragm 14, with a wide gear 16 meshing at the end of the second rack 15 away from the elastic diaphragm 14; the wide gear 16 is rotatably engaged with the inner wall of the fixed seat 4, and a third rack 17 is meshed with the wide gear 16; the end of the third rack 17 away from the wide gear 16 contacts the transmission block 11, and the third rack 17 is slidably engaged with both the fixed plate 10 and the fixed seat 4. In this embodiment, the third rack 17 is an incomplete rack, and the wide gear 16 simultaneously maintains engagement with both the second rack 15 and the third rack 17; and since the third rack 17 is in contact with the transmission block 11, during the negative pressure establishment phase, the transmission block 11 will not drive the third rack 17 to move, so that neither the wide gear 16 nor the second rack 15 moves, thereby allowing the elastic diaphragm 14 to keep the switching valve 7 in the closed state.

[0060] When the first rack 8 drives the transmission block 11 to move for the first time, the locking rod engages with the top end of the irregular groove to lock the position of the transmission block 11; when the second rack 15 drives the transmission block 11 to move for the second time, the locking rod disengages from the top end of the irregular groove to unlock the transmission block 11.

[0061] Specifically, when the negative pressure chamber 5 maintains a continuous negative pressure, and the newborn urinates, the urine enters the collection hood 1 and flows through the guide tube 2 to the switching valve 7. The urine pressure and negative pressure work together on the elastic diaphragm 14. Because the elastic diaphragm 14 is made of elastic material, its protruding portion flips under pressure; the portion that originally protruded towards the inner wall of the valve body protrudes in the opposite direction, breaking away from its contact with the inner wall of the valve body, thereby opening the fluid passage and allowing urine to flow from the guide tube 2 to the input tube.

[0062] As the elastic diaphragm 14 flips, it moves the second rack 15, which is bonded to its inner wall. The second rack 15 drives the wide gear 16 to rotate, and the wide gear 16 then drives the third rack 17 (incomplete rack) to slide along the fixed base 4 and the fixed plate 10. The end of the third rack 17 away from the wide gear 16 contacts the transmission block 11 and pushes the transmission block 11 to produce displacement. This displacement causes the locking rod to disengage from the top end of the irregular groove, releasing the lock on the transmission block 11. This movement process is as described in the heart-shaped structure of the irregular groove above. Because the top end of the heart-shaped irregular groove is offset to the left, during the process of the third rack 17 driving the transmission block 11 to slide again, the locking rod will slide past the right side of the irregular groove. The elastic restoring force of the spring 18 will push the transmission block 11, causing the locking rod to slide from the right side of the irregular groove to the bottom of the irregular groove. After resetting, the compressed spring 18 pushes the transmission block 11, the stop rod 12, and the piston 6 to reset, and the negative pressure chamber 5 changes from negative pressure to positive pressure, pushing the urine into the cryopreservation tube 3 through the output tube. During this process, since the first rack 8 is magnetically engaged with the connecting rod, the first rack 8 will disengage from the magnetic engagement with the connecting rod as the transmission block 11 drives the stop rod 12 to reset. After the cryopreservation tube 3 is subsequently unscrewed and disassembled, the first rack 8 moves in the opposite direction to the initial position corresponding to the connecting rod, achieving magnetic attraction through the first and second magnetic blocks.

[0063] After urine delivery is completed, the elastic diaphragm 14 returns to its initial convex shape due to its own elasticity, and the transmission block 11 moves in the opposite direction, which pushes the third rack 17 to reset. This reset engages with the wide gear 16, causing the wide gear 16 to rotate. The rotation of the wide gear 16 then drives the second rack 15 to reset. Thus, the reset of the second rack 15 assists the elastic diaphragm 14 in closing the switching valve 7. This auxiliary force can block the flow of fluid and further improve the sealing of the device.

[0064] In this embodiment, the switching valve 7 and the release mechanism, through the linkage design of various components, convert the deformation of the elastic diaphragm 14 into the unlocking action of the locking rod, thereby achieving automatic control of the sampling process. Conventional locking structures (such as ratchet, snap-lock, electromagnetic lock) can usually only achieve locking in one direction and manual or electronic unlocking, and cannot distinguish between the displacements from two different sources: installation locking and trigger unlocking. This solution uses an asymmetrical heart-shaped groove, utilizing the different tilt directions on the left and right sides of the groove and the offset vertex at the top, so that the locking rod enters and engages along the left side and disengages along the right side in two movements, respectively, achieving mechanical sequential control. This design reduces additional power or manual intervention, has a compact structure, and enables automatic collection of neonatal urine. All parts in contact with the skin in this solution are designed for single use and are discarded after use without the need for cleaning and disinfection, further reducing the workload of nursing staff.

[0065] Example 2:

[0066] The difference from Embodiment 1 is that this embodiment also includes a refrigeration mechanism for providing cooling to the cryopreservation tube 3. The refrigeration mechanism includes a phase change cold storage ring and an activation needle. The phase change cold storage ring is located at the connection between the fixing base 4 and the cryopreservation tube 3. A sealing membrane is provided on the outer side of the phase change cold storage ring, and the activation needle slides against the inner wall of the fixing base 4. The tip of the activation needle faces the sealing membrane, and the side of the activation needle away from the sealing membrane contacts the third toothed rack 17. In this embodiment, the movement stroke of the activation needle is set so that the activation needle punctures the sealing membrane only when urine enters the cryopreservation tube 3. The fixing base 4 can be fixed to the outside of the diaper, the inside of the baby's clothing, or the edge of the bed using medical double-sided tape or straps, adapting to different care procedures for newborns, such as changing diapers after sleep, breastfeeding, or bowel movements, without repeated disassembly. The activation needle's movement has minimal vibration and no noise, and will not startle or stimulate the newborn.

[0067] The specific implementation process is as follows: When the switching valve 7 is opened and urine is pushed into the cryopreservation tube 3, the transmission block 11, under the action of the spring 18, drives the push rod 12 and piston 6 to reset. At this time, the third rack 17 slides in the opposite direction with the movement of the transmission block 11, and its position change directly serves as the signal source for refrigeration triggering. With the reset movement of the third rack 17, the activation needle is pushed along the inner wall of the fixed seat 4 towards the sealing film. The tip of the activation needle has a sharp cutting edge, which, under the thrust of the third rack 17, pierces the sealing film wrapped around the outside of the phase change cold storage ring.

[0068] The rupture of the sealing film breaks the inert state of the phase change cold storage ring; the high-efficiency phase change material (PCM) pre-filled inside the phase change cold storage ring located at the connection between the fixed seat 4 and the cryogenic tube 3 is instantly exposed to the environment or comes into contact with the outer wall of the cryogenic tube 3. Since the melting point of the phase change material is lower than room temperature (e.g. -20°C) and it is in a supercooled state or introduced into a crystal nucleus by puncture, the phase change material undergoes a phase change (e.g., releasing latent heat of solidification when changing from liquid to solid, or absorbing heat when changing from solid to liquid), causing the local temperature of the cryogenic tube 3 to drop rapidly to about -20°C and remain there for at least 20-30 minutes.

[0069] The phase change cold storage ring is closely attached to the bottom and sidewalls of cryovial 3, and rapidly absorbs the heat of the urine sample inside cryovial 3 using the latent heat of phase change. Because the phase change material can maintain a constant temperature during the phase change process, this mechanism can reduce the sample temperature to a preset low temperature range in a short time, reduce enzyme activity and bacterial growth, and ensure that the biological activity of the neonatal urine sample is not destroyed.

[0070] In this embodiment, the activation of the activation needle, the opening of the switching valve 7, and the unlocking of the locking mechanism are all achieved by the same driving source, reducing additional operations and ensuring that the cooling function is activated as soon as urine enters the cryopreservation tube 3. Existing neonatal urine collection components often neglect temperature control from sample collection to cryopreservation, or require external ice packs, cold storage boxes, or other independent equipment, which are cumbersome to operate and have uncontrollable temperatures. This solution integrates the activation of the cooling mechanism into the mechanical linkage chain triggered by urination, utilizing the puncture-type start-up method of the phase change cold storage ring, resulting in a compact structure and high reliability, improving temperature protection for the sample from collection to cryopreservation.

[0071] Example 3:

[0072] As attached Figure 7 As shown, the difference from Embodiment 2 is that a number of elastic clips 19 are also hinged to the fixing base 4, and the elastic clips 19 are distributed circumferentially on the outside of the cryopreservation tube 3; the fixing base 4 is provided with a locking mechanism for locking the elastic clips 19.

[0073] The locking mechanism includes a locking nut 20 threaded into the outer wall of the fixing seat 4. An inclined block 21 is integrally formed on the side of the elastic clip 19 away from the fixing seat 4. An inclined groove is formed inside the locking nut 20 to contact the inclined block 21. In this embodiment, the surfaces of the elastic clip 19 and the locking nut 20 are rounded and coated with a medical-grade silicone coating to prevent scratching of the newborn or caregivers due to improper operation. During clinical operation, medical staff can first complete the insertion, negative pressure establishment, and locking of the cryopreservation tube 3, and then dress the newborn in diapers and pants. The operation is smooth and does not affect daily activities.

[0074] The specific implementation process is as follows: Several elastic clips 19 are circumferentially hinged to the outer edge of the fixing base 4. In their natural state, each elastic clip 19 opens outward, forming an opening larger than the outer diameter of the cryopreservation tube 3, facilitating the smooth screwing of the cryopreservation tube 3 into the fixing base 4. The locking nut 20 is threaded onto the outer wall of the fixing base 4. At this time, the locking nut 20 is in a loose state, and its internal inclined groove maintains a gap or slight contact with the inclined block 21 at the distal end of the elastic clip 19, without generating clamping force. Medical personnel screw the cryopreservation tube 3 into the fixing base 4 (as described in the aforementioned transmission mechanism). After the negative pressure is established and locked, the cryopreservation tube 3 has been initially positioned.

[0075] When locking is required, medical staff manually tighten the locking nut 20, which moves towards the elastic clamp 19. The inclined groove inside the locking nut 20 gradually contacts the inclined block 21 on the elastic clamp 19, creating relative sliding. The inclined angle of the groove is designed so that as the locking nut 20 is screwed in, the inclined groove forces the inclined block 21 and the entire elastic clamp 19 to swing inward around the hinge point. Each elastic clamp 19 synchronously converges towards the center, tightly adhering to the outer wall of the cryopreservation tube 3, forming a uniform circumferential clamping force.

[0076] When the cryopreservation tube 3 needs to be removed, first loosen the locking nut 20 in the reverse direction. The inclined groove of the locking nut 20 disengages from the inclined block 21, and the elastic clamp 19 automatically opens outward under its own elastic restoring force, releasing the clamp on the cryopreservation tube 3. Conventional cryopreservation tube 3 fixing seats 4 rely only on threads or simple buckles, which are prone to loosening due to material shrinkage during repeated freezing and thawing. In this embodiment, the independent locking nut 20 drives the elastic clamp 19 to achieve circumferential clamping. The clamping force is adjustable, does not depend on the thread precision of the cryopreservation tube 3 itself, and the inclined wedge clamping structure has self-locking characteristics, making it difficult to loosen, further improving the stability of the device.

[0077] Example 4:

[0078] The difference from Embodiment 3 is that the side of the collection cover 1 away from the guide tube 2 is also provided with several sealing protrusions; the connection between the collection cover 1 and the guide tube 2 is also provided with a universal joint. The overall structure is small and thin, and with the self-adjusting capability of the universal joint, it can fully adapt to scenarios such as newborn crying, twisting, turning over, and feeding.

[0079] The specific implementation process is as follows: Multiple annular sealing protrusions (e.g., 2-3 rings, protrusion height 0.5-1.0 mm, cross-section semi-circular or trapezoidal) are evenly distributed on the contact surface of the collection cover 1. A universal joint connects the outlet of the collection cover 1 to the guide pipe 2, allowing the collection cover 1 to achieve an angle deflection of ±30° to ±45° within space, and possessing a certain degree of axial expansion and contraction elasticity. Initially, the collection cover 1 is naturally extended, the sealing protrusions are not compressed, and the universal joint is in a free state.

[0080] In the actual operation of collecting urine from newborns, medical staff gently place the collection cover 1 on the genital area of ​​the newborn. At this time, several sealing protrusions on the side of the collection cover 1 away from the drainage tube 2 undergo elastic deformation when in contact with the skin, conforming to the irregular skin contour of the newborn and forming multiple physical sealing defenses. This design not only uses elastic recovery force to continuously press the skin to prevent urine from leaking from the edge, but also avoids skin redness or damage caused by prolonged pressure by dispersing local pressure.

[0081] Meanwhile, the universal joint located at the connection between the collection cover 1 and the drainage tube 2 plays a compensating role, allowing the collection cover 1 to rotate and bend relative to the drainage tube 2. When the child frequently changes position due to crying, kicking, or sleeping, the joint automatically absorbs the displacement difference, confining the mechanical stress generated by external pulling and bending within itself, isolating the external force transmitted to the skin contact surface, and preventing the device from falling off or the interface from becoming loose. The two work together to achieve connection and drainage during neonatal activity, improving the comfort, safety, and integrity of the sampling process.

[0082] Example 5:

[0083] As attached Figure 1As shown, the difference from Embodiment 4 is that the outer wall of the fixing base 4 can also be detachably connected to an excess collection chamber 22, which is connected to the switching valve 7. In this embodiment, the excess collection chamber 22 is made of medical-grade polycarbonate (PC) or cyclic olefin copolymer (COC), and the detachable interface adopts a leak-proof quick-connect design, which can be operated with one hand.

[0084] The specific implementation process is as follows: First, the excess collection chamber 22 made of transparent medical plastic is sealed and connected to the preset communication port on the outer wall of the fixing base 4 through a quick-connect plug or threaded interface. This communication port is connected in parallel with the outlet side of the switching valve 7 through an internal flow channel, and a miniature overflow valve or conductive structure is provided in this parallel flow path. Under normal circumstances, the flow resistance on the cryopreservation tube 3 side is lower.

[0085] After the third rack 17 completes the unlocking action, it is pushed in the opposite direction as the transmission block 11 reverses and resets (as mentioned above, the reverse movement of the transmission block 11 will push the third rack 17). The wide gear 16 reverses, driving the second rack 15 and the elastic diaphragm 14 to reset, and the switching valve 7 gradually returns to the closed state. If there is still urine remaining in the negative pressure chamber 5, the guide tube 2, or the collection hood 1 at this time (or because the amount of urine exceeds the remaining volume of the cryopreservation tube 3 and cannot completely enter the cryopreservation tube 3), this urine can no longer enter the cryopreservation tube 3 through the closed main passage. To avoid urine retention causing contamination or leakage, this embodiment keeps the parallel flow channel on the outlet side of the switching valve 7 open (or unidirectional), allowing residual urine to flow into the excess collection chamber 22.

[0086] In actual clinical scenarios, neonatal urination may last for several seconds. If the total urine volume exceeds the effective volume of cryovial 3 (e.g., >1.5 mL), cryovial 3 will be filled first, preventing subsequent urine from entering. At this time, the elastic diaphragm 14 has reset and the passage is closed, causing urine to stagnate upstream of the valve and in the guide tube 2. As the third rack 17 resets, the bypass connected to the excess collection chamber 22 becomes the only outlet, and urine flows into the excess collection chamber 22 through this bypass for temporary storage. The transparent chamber wall allows medical staff to visually confirm whether an over-collection has occurred and decide whether additional sampling or recording of the total urine volume is necessary.

[0087] After sampling, medical staff first disassemble cryopreservation tube 3 according to the aforementioned steps (directly cap and freeze). Then, remove the excess collection chamber 22 from the outer wall of the fixing base 4; if there is urine in the chamber, it is discarded as excess sample (or retained as needed after measurement, but it is not recommended to mix it into cryopreservation tube 3 to avoid contamination).

[0088] Conventional designs lack timing control for shunting after the main pathway is closed, which can easily lead to urine backflow or leakage during aspiration. This solution utilizes the timing design of the overload collection chamber 22 in cryopreservation tube 3 to ensure that cryopreservation tube 3 is fully loaded first, avoiding insufficient sample due to bypass shunting during negative pressure aspiration. The structure is compact and the logic is clear, improving the reliability and ease of operation of overload urine collection.

[0089] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A neonatal urine collection and cryopreservation assembly, comprising a collection cover (1), a drainage tube (2), a cryopreservation tube (3), and a fixing base (4), wherein the collection cover (1), the drainage tube (2), and the cryopreservation tube (3) are all interconnected; characterized in that, It also includes a negative pressure chamber (5), in which a piston (6) is slidably fitted; the cryopreservation tube (3) is detachably connected to the fixed seat (4), the negative pressure chamber (5) is fixedly connected to the outer wall of the fixed seat (4), and the fixed seat (4) is provided with a transmission mechanism for driving the piston (6) to move; when the cryopreservation tube (3) is screwed into the fixed seat (4), the transmission mechanism drives the piston (6) to move, so that negative pressure is generated in the negative pressure chamber (5); It also includes a switching valve (7) for connecting the negative pressure chamber (5) and the cryopreservation tube (3). The switching valve (7) has an open state and a closed state. When the switching valve (7) is closed, it blocks the fluid connection. When urine enters the collection hood (1) and generates liquid pressure, the liquid pressure causes the switching valve (7) to switch to the open state. The negative pressure generated by the negative pressure chamber (5) delivers the urine into the cryopreservation tube (3).

2. The neonatal urine collection and cryopreservation assembly according to claim 1, characterized in that, The transmission mechanism includes a first rack (8) that slides with the fixed seat (4), and the first rack (8) meshes with an outer gear ring (9); the outer gear ring (9) is rotatably connected to the inner wall of the fixed seat (4), and the outer gear ring (9) is detachably connected to the cryopreservation tube (3); a connecting rod is fixedly connected to the piston (6), and a first magnetic block is fixedly connected to the end of the connecting rod away from the piston (6), the first magnetic block is magnetically engaged with a second magnetic block, and the second magnetic block is fixedly connected to the end of the first rack (8) away from the cryopreservation tube (3).

3. The neonatal urine collection and cryopreservation assembly according to claim 2, characterized in that, The fixed seat (4) is also provided with a locking mechanism for locking the piston (6) to slide; the locking mechanism includes a fixed plate (10) fixedly connected to the outer wall of the fixed seat (4), a transmission block (11) is slidably fitted on the inner side wall of the fixed plate (10), and a stop rod (12) is fixedly connected on the side of the transmission block (11) away from the fixed seat (4); the end of the stop rod (12) away from the transmission block (11) is fixedly connected to the connecting rod, and a swing rod (13) is also hinged to the bottom of the fixed plate (10), and a special groove is opened at the bottom of the transmission block (11). A locking rod is rotatably connected to the end of the swing rod (13) away from the fixed plate (10), and the locking rod is located in the special groove and slidably fitted with the special groove; a spring (18) is sleeved on the outer wall of the stop rod (12), and the two ends of the spring (18) abut against the inner wall of the transmission block (11) and the fixed plate (10) respectively.

4. The neonatal urine collection and cryopreservation assembly according to claim 3, characterized in that, The switching valve (7) includes a valve body and an elastic diaphragm (14). The protruding part of the elastic diaphragm (14) abuts against the inner wall of the valve body, and the two ends of the elastic diaphragm (14) are fixedly connected to the inner wall of the valve body. The side of the negative pressure chamber (5) away from the connecting rod is connected to the input pipe and the output pipe. A one-way valve is also provided on the connection path between the input pipe and the output pipe and the negative pressure chamber (5). The end of the output pipe away from the negative pressure chamber (5) is connected to the cryopreservation tube (3). One side of the valve body is connected to the guide pipe (2), and the other side of the valve body is connected to the end of the input pipe away from the negative pressure chamber (5). The switching valve (7) is also provided with a release mechanism for releasing the locking rod limit.

5. The neonatal urine collection and cryopreservation assembly according to claim 4, characterized in that, The release mechanism includes a second rack (15) fixedly connected to the inner wall of the elastic diaphragm (14), and a wide gear (16) meshes at the end of the second rack (15) away from the elastic diaphragm (14); the wide gear (16) is rotatably engaged with the inner wall of the fixed seat (4), and a third rack (17) meshes with the wide gear (16); the end of the third rack (17) away from the wide gear (16) contacts the transmission block (11), and the third rack (17) is slidably engaged with both the fixed plate (10) and the fixed seat (4).

6. The neonatal urine collection and cryopreservation assembly according to claim 5, characterized in that, It also includes a refrigeration mechanism for providing refrigeration to the cryopreservation tube (3), the refrigeration mechanism including a phase change cold storage ring and an activation needle; the phase change cold storage ring is located at the connection between the fixed seat (4) and the cryopreservation tube (3), a sealing membrane is provided on the outside of the phase change cold storage ring, and the activation needle slides and fits against the inner wall of the fixed seat (4); the tip of the activation needle faces the sealing membrane, and the side of the activation needle away from the sealing membrane contacts the third rack (17).

7. The neonatal urine collection and cryopreservation assembly according to claim 6, characterized in that, Several elastic clips (19) are also hinged on the fixed base (4), and the elastic clips (19) are distributed circumferentially on the outside of the cryopreservation tube (3); the fixed base (4) is provided with a locking mechanism for locking the elastic clips (19).

8. The neonatal urine collection and cryopreservation assembly according to claim 7, characterized in that, The locking mechanism includes a locking nut (20) threaded to the outer wall of the fixed seat (4), and an inclined block (21) fixedly connected to the side of the elastic clip (19) away from the fixed seat (4). The locking nut (20) has an inclined groove inside that contacts the inclined block (21).

9. The neonatal urine collection and cryopreservation assembly according to claim 8, characterized in that, The side of the collection cover (1) away from the guide pipe (2) is also provided with several sealing protrusions; a universal joint is also provided at the connection between the collection cover (1) and the guide pipe (2).

10. The neonatal urine collection and cryopreservation assembly according to claim 9, characterized in that, The outer wall of the fixed seat (4) can also be detachably connected to the excess collection chamber (22), which is connected to the switching valve (7).

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