A negative pressure elution cervical exfoliated cell sampler

Abstract

This invention relates to the field of sampler technology, specifically to a negative pressure elution cervical exfoliated cell sampler. It includes a sampling rod body, which is a hollow cylindrical structure. One end of the sampling rod body has an operating component, and the other end, away from the operating component, has a sampling head. A piston assembly and a separator are slidably disposed within the inner cavity of the sampling rod body, forming a primary sample mixing chamber for storing irrigation fluid. The operating component has a driving component within its inner cavity. By holding the handle, the sampling rod body and sampling head are inserted into the patient's vagina. Because the diameter of the cylindrical structure of the sampling rod body is significantly smaller than the expansion size of the dilator, it naturally adapts to the human physiological structure without forcibly opening the vaginal cavity. Manually pushing the lever slides within the handle's inner cavity, simultaneously driving the piston rod and piston head to move, causing the irrigation fluid from the primary sample mixing chamber to be sprayed out in a scattering pattern through the sampling hole of the sampling head.

Description

Technical Field

[0001] This invention relates to the field of sampler technology, and more specifically, to a negative pressure elution cervical exfoliated cell sampler. Background Technology

[0002] Cervical cytology is a fundamental part of routine gynecological examinations, also known as cervical cancer screening or TCT testing. Currently, the routine sampling procedure is performed by medical staff in hospitals. Before sampling, medical staff first use a vaginal speculum to open the patient's vagina, then insert a sampling swab into the vagina to collect exfoliated cells. The collected sample is then placed in a test tube for dilution, as illustrated by Chinese patent publication number CN108903980A, which describes a cervical sampling device.

[0003] Considering that the mechanical pressure when using a dilator can easily cause local ischemia of the vaginal wall mucosa, some patients may experience discomfort such as burning pain and distension, which may cause temporary tissue damage, especially for people with sensitive constitutions. The complicated operation process also increases the risk of cross-infection and sample contamination, affecting the accuracy of testing and the patient's medical experience. Summary of the Invention

[0004] The purpose of this invention is to provide a negative pressure elution cervical exfoliated cell sampler to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides a negative pressure elution cervical exfoliated cell sampler, comprising a sampling rod body, wherein the sampling rod body is a hollow cylindrical structure, one end of which is provided with an operating component, and the other end away from the operating component is provided with a sampling head;

[0006] The inner cavity of the sampling rod body is slidably provided with a piston assembly and a separator, which form a primary sample mixing chamber for storing the rinsing fluid;

[0007] The operating component has a drive component inside, which drives the piston component and the separator to slide synchronously by means of elasticity, so that the irrigation fluid of the primary sample mixing chamber area is sprayed into the cervical area through the sampling head.

[0008] During reabsorption, the piston assembly and the separator slide synchronously in opposite directions during the elastic reset process via the drive assembly. First, the mixed liquid is drawn into the primary sample mixing chamber, and then the separator gradually seals the primary sample mixing chamber, allowing the subsequent high-concentration cell fluid to enter the high-concentration sample mixing chamber, thus achieving sample stratification collection. The sampling head has multiple sampling holes on its surface and is hemispherical. An end cap is fitted on the outer surface of the sampling head. The operating assembly includes a handle for holding the sampling rod body.

[0009] The sampling rod body uses a cylindrical structure with a diameter significantly smaller than the expander's unfolded size, allowing it to naturally adapt to the human physiological structure without forcibly opening the vaginal cavity. The separator, piston assembly, and inner wall of the sampling rod body form a closed primary sample mixing chamber, preventing irrigation fluid leakage and ensuring sufficient liquid is sprayed out during irrigation to guarantee the cervical flushing effect. As the separator moves with the piston assembly, it narrows the channel between the primary sample mixing chamber and the high-concentration sample mixing chamber. The deep high-concentration cell fluid aspirated under negative pressure cannot enter the primary sample mixing chamber due to channel resistance and is instead stored in the high-concentration sample mixing chamber. This achieves a graded effect of "low-concentration sample storage in the primary sample mixing chamber and high-concentration sample storage in the high-concentration sample mixing chamber," avoiding cell concentration dilution caused by mixing samples of different concentrations.

[0010] As a further improvement to this technical solution, the piston assembly includes a piston rod slidably connected to the inner cavity of the sampling rod body. A piston head is fixedly connected to the end of the piston rod near the sampling head. The separator includes a connecting rod fixedly connected to the end of the piston head. A baffle is fixedly connected to the end of the connecting rod away from the piston head. A fixing frame is fixedly connected to the inner wall of the sampling rod body. When the piston assembly is in the initial position, the surface of the baffle and the fixing frame are tightly fitted together, and the two cooperate to form a limiting structure, which simultaneously cooperates with the piston head to enclose a primary sample mixing chamber. When the piston assembly is in the initial position, the baffle and the fixing frame are tightly fitted together to form a sealing structure. The piston head, connecting rod, baffle, and inner wall of the sampling rod body together enclose the primary sample mixing chamber, ensuring stable storage of the rinsing solution.

[0011] As a further improvement to this technical solution, the end of the piston rod away from the piston head is connected to the drive assembly. The drive assembly is located in the inner cavity of the handle. The drive assembly includes a paddle that slides in the inner cavity of the handle. A connecting frame is fixedly connected to the surface of the paddle. The end of the connecting frame away from the paddle is fixedly connected to the piston rod. A support frame is fixedly connected to the bottom of the inner cavity of the handle. The inside of the support frame is fixedly connected to the surface of the damper, and the output end of the damper is fixedly connected to the surface of the connecting frame.

[0012] The damper of the drive assembly rebounds, causing the piston head to move in the opposite direction, creating a negative pressure at the sampling head. The liquid containing exfoliated cells is drawn back through the sampling hole into the high-concentration sample mixing chamber, allowing the liquid in the high-concentration sample mixing chamber to be quickly guided to the primary sample mixing chamber for storage.

[0013] As a further improvement to this technical solution, an elongated hole is provided on the surface of the handle, and a paddle is slidably connected to the elongated hole. An operating hole is provided between the paddle and the elongated hole. A slide rail is fixedly connected to the bottom of the inner cavity of the handle, and a slider is fixedly connected to the bottom of the paddle. The surface of the slider slides on the inner wall of the slide rail.

[0014] By applying force with your finger, you can push the paddle to slide within the handle's inner cavity. As the paddle slides, the slider at its bottom moves synchronously along the slide rail within the handle's inner cavity. Linear constraints effectively limit the paddle's offset, ensuring that it always slides along a preset straight trajectory.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0016] 1. In this negative pressure elution cervical exfoliated cell sampler, the sampling rod body and sampling head are inserted into the patient's vagina by holding the handle. Since the diameter of the cylindrical structure of the sampling rod body is significantly smaller than the expansion size of the dilator, it can naturally adapt to the human physiological structure without forcibly opening the vaginal cavity.

[0017] Manually pushing the lever slides within the handle's inner cavity, simultaneously driving the piston rod and piston head to move. This causes the irrigation fluid from the primary sample mixing chamber to be sprayed out in a scattering pattern through the sampling port of the sampling head. The hemispherical sampling head ensures that the irrigation fluid evenly covers the cervical sampling area, guaranteeing that exfoliated cells are fully shed and mixed with the irrigation fluid. The thrust generated by the damper's rebound quickly guides the liquid in the high-concentration sample mixing chamber to the primary sample mixing chamber for storage, completing the sampling process. The entire sampling process does not cause significant pressure on the patient's vagina, resulting in a better sampling experience and avoiding discomfort associated with gynecological examinations. The rinsing and aspiration actions can be completed with just one hand, simplifying the operation steps for medical staff and shortening the sampling time.

[0018] 2. In this negative pressure elution cervical exfoliated cell sampler, in the initial static state, the damper is in a naturally extended state. Its continuous output elastic force pushes the connecting frame and piston rod, keeping the piston assembly in the initial position. At this time, the disc-shaped baffle is tightly abutted against the annular fixing frame under the action of elasticity. Together with the piston head and the inner wall of the sampling rod body, a primary sample mixing chamber is formed, ensuring that the irrigation fluid remains stably stored during the movement of the instrument and reducing the risk of liquid shaking or leakage.

[0019] 3. In this negative pressure elution cervical exfoliated cell sampler, after irrigation, during the back aspiration process, the damper first releases its buffer elasticity. During this process, the separator connected to the piston head moves synchronously, and its baffle gradually approaches the fixed frame, causing the connecting channel between the primary sample mixing chamber and the high-concentration sample mixing chamber to gradually narrow. By controlling the narrowing of the channel through the separator, low-concentration and high-concentration cell samples are stored in the primary sample mixing chamber and the high-concentration sample mixing chamber respectively. This avoids the reduction in target cell concentration caused by direct mixing of samples of different concentrations, ensuring that the cell enrichment solution in the high-concentration sample mixing chamber can provide clearer and more accurate information for pathological testing, reducing the risk of missed diagnosis and misdiagnosis.

[0020] 4. In this negative pressure elution cervical exfoliated cell sampler, the negative pressure is generated by the rebound of the piston assembly. Combined with the small ventilation gap between the uterine cavity and the outside, the pressure is buffered to avoid damage to cervical tissue due to excessive negative pressure. The flexible contact design of the semi-circular sampling head further reduces the risk of mechanical damage. It adopts a "step-by-step recovery + layered storage" method. The channel narrowing is controlled by the separator to prioritize the storage of low-concentration liquid and then guide the high-concentration cell mixture to ensure that the final sample cell concentration is maximized, which meets the needs of pathological testing. No external forced air suction device is required, simplifying the operation process. The initial volume of irrigation fluid does not need to be strictly equal to the recovery volume, which ensures the effect of flushing cells and reduces liquid residue interference, thereby improving sampling efficiency and sample quality. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure assembly of the present invention;

[0022] Figure 2 This is a schematic diagram of the piston assembly structure of the present invention;

[0023] Figure 3 This is a schematic diagram of the slider structure of the present invention;

[0024] Figure 4 This is a schematic diagram of the preparation sampling stage of the present invention;

[0025] Figure 5 This is a schematic diagram of the rinsing stage of the present invention;

[0026] Figure 6 This is a schematic diagram of the structure of the primary sampling stage of the present invention;

[0027] Figure 7 This is a schematic diagram of the structure for completing the sampling stage of the present invention.

[0028] The meanings of the labels in the diagram are as follows:

[0029] 100. Sampling rod body;

[0030] 200. Operating component; 210. Handle; 2101. Elongated hole; 2102. Operating hole; 220. Slide rail;

[0031] 300. Piston assembly; 310. Piston rod; 320. Piston head;

[0032] 330, Divider; 3301, Connecting rod; 3302, Baffle; 3303, Fixing bracket;

[0033] 400. Drive assembly; 410. Paddle; 420. Slider; 430. Connecting bracket; 440. Support bracket; 450. Damper;

[0034] 500. Sampling head; 501. Sampling hole;

[0035] 600, end cap; a1, primary sample mixing chamber; a2, high-concentration sample mixing chamber. Detailed Implementation

[0036] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0037] Example 1

[0038] Please see Figures 1-7 As shown, this embodiment provides a negative pressure elution cervical exfoliated cell sampler, including a sampling rod body 100. The sampling rod body 100 is a hollow cylindrical structure, with an operation component 200 at one end and a sampling head 500 at the other end away from the operation component 200.

[0039] The inner cavity of the sampling rod body 100 is slidably provided with a piston assembly 300 and a separator 330, which together form a primary sample mixing chamber a1 for storing rinsing fluid;

[0040] The operating component 200 has a drive component 400 inside. The drive component 400 drives the piston component 300 and the separator 330 to slide synchronously by means of elasticity, so that the irrigation fluid of the primary sample mixing chamber a1 area is sprayed to the cervical area through the sampling head 500.

[0041] During the reabsorption process, the piston assembly 300 and the separator 330 slide synchronously in opposite directions during the elastic reset process of the drive assembly 400. The mixture is first aspirated into the primary sample mixing chamber a1, and then the separator 330 gradually seals the primary sample mixing chamber a1, so that the subsequent high-concentration cell fluid enters the high-concentration sample mixing chamber a2, thereby achieving sample stratification collection.

[0042] Primary aspiration stage: The initial aspirated liquid containing rinsing fluid and cells flushed off first enters the high-concentration sample mixing chamber a2, and is then pushed into the primary sample mixing chamber a1 by the movement of piston assembly 300 and separator 330.

[0043] Layered sealing stage: When the separator 330 gradually closes the primary sample mixing chamber a1, the high concentration of cell fluid that is subsequently aspirated is trapped in the high concentration sample mixing chamber a2 due to the restricted channel of the primary sample mixing chamber a1, thus achieving cell enrichment.

[0044] Flushing phase: When the irrigation fluid is sprayed out, it washes the surface of the cervix, suspending the exfoliated cells in the liquid and forming a low-concentration mixture that is mainly stored in the primary sample mixing cavity a1;

[0045] Later stage of reabsorption: Since most of the liquid has been collected by the initial reabsorption, the small amount of liquid aspirated later reaches the high-concentration sample mixing chamber a2 due to the reduced flow rate and cell sedimentation, which is consistent with the laws of fluid dynamics and cell distribution.

[0046] Considering that existing sampling methods are not only cumbersome and time-consuming, but also prone to causing local ischemia of the vaginal wall mucosa due to the mechanical pressure of the dilator, some patients experience discomfort such as burning pain and a feeling of heaviness. This can cause temporary tissue damage, especially in sensitive individuals. The complex procedures also increase the risk of cross-infection and sample contamination, affecting testing accuracy and the patient's experience. Therefore, a new method is proposed where the sampling rod body 100 and sampling head 500 are inserted into the patient's vagina using a handheld operating component 200. At this point, the diameter of the cylindrical structure of the sampling rod body 100 is significantly smaller than the expanded size of the dilator, allowing it to naturally adapt to the human body without forcibly opening the vaginal cavity. The sampling device utilizes a mechanical structure. By actuating the drive assembly 400, the piston assembly 300 and the separator 330 slide within the sampling rod body 100. The irrigation fluid in the primary sample mixing chamber a1 is sprayed out through the sampling head 500 to flush the cervix and surrounding area. The shed cervical cells mix with the irrigation fluid. The rebound force of the drive assembly 400 drives the piston assembly 300 and the separator 330 to slide in the opposite direction, drawing the irrigation fluid and mixed cells back into the primary sample mixing chamber a1 under negative pressure, thus completing the sampling. The entire sampling process does not cause significant pressure on the patient's vagina, resulting in a better sampling experience and avoiding discomfort associated with gynecological examinations.

[0047] Considering the dilution of cervical mucus, the concentration of the mixture of irrigation fluid and cells is low in the initial aspiration stage. During continuous aspiration, cells with relatively low concentrations are aspirated first, followed by deeper cells with higher concentrations. If all of these cells are stored in the primary sample mixing chamber a1, samples of different concentrations at different times will be directly mixed, potentially causing the concentration of target cells in the sample to fall below the detection threshold, affecting the accuracy of pathological diagnosis. Therefore, irrigation fluid is pre-injected into the primary sample mixing chamber a1 of the sampling rod body 100. The separator 330 and piston assembly 300, and the sampling rod body... The inner wall of the body 100 fits together to form a closed primary sample mixing cavity a1, ensuring that the rinsing fluid will not leak. At this time, the high-concentration sample mixing cavity a2 is in an empty state. The drive component 400 in the operating component 200 pushes the piston component 300 and the separator 330 to slide in the inner cavity of the sampling rod body 100 with the help of elasticity. The rinsing fluid in the primary sample mixing cavity a1 area is sprayed out through the sampling head 500 into the cervical area to irrigate the cervix, so that the rinsing fluid is fully mixed with the cervical surface and superficial cells. The drive component 400 begins to elastically reset and synchronously drive The piston assembly 300 and the separator 330 slide in opposite directions, creating negative pressure at the sampling head 500. At this time, due to factors such as dilution of cervical mucus, the cell concentration mixed with the irrigation fluid is low. This low-concentration mixture is first drawn into the primary sample mixing chamber a1. During this process, the separator 330 has not yet completely sealed the piston assembly 300, and there is still some communication between the primary sample mixing chamber a1 and the high-concentration sample mixing chamber a2. However, the main sample is stored in the primary sample mixing chamber a1. As the drive assembly 400 continues to reset, the separator 330 gradually moves away from the piston assembly. The sealing of component 300 gradually narrows the channel between the primary sample mixing chamber a1 and the high-concentration sample mixing chamber a2. Continuous negative pressure aspiration draws in the relatively high-concentration deep cell mixture. Due to the narrowing of the channel between the separator 330 and the piston assembly 300, the liquid containing more cells in the later aspiration is less likely to enter the primary sample mixing chamber a1, but instead enters the high-concentration sample mixing chamber a2 for storage. This achieves graded collection of samples of different concentrations, avoids direct mixing of low-concentration and high-concentration samples, ensures the cell concentration of the sample in the high-concentration sample mixing chamber a2, and improves the accuracy of pathological diagnosis.

[0048] The negative pressure of the sampler is not achieved by external forced air extraction, but by the mechanical force of the piston assembly 300 driven by the drive component 400 and the volume change of the closed cavity. In the initial state, the primary sample mixing cavity a1 is connected to the uterine cavity through the sampling head 500. However, the uterine cavity itself is a relatively closed physiological space (not absolutely sealed), and the sampling rod body 100 is a cylindrical structure with low adhesion to the vaginal wall, leaving a small gap. When the drive component 400 rebounds and pushes the piston assembly 300 to reset, the volume of the primary sample mixing cavity a1 expands and generates negative pressure. At this time, the liquid in the uterine cavity is drawn back under the action of pressure difference, but the small ventilation gap between the uterine cavity and the outside will buffer the pressure and avoid excessive negative pressure.

[0049] Meanwhile, the initial volume of rinsing fluid stored in the primary sample mixing chamber a1 is primarily used to flush out exfoliated cells. After the rinsing fluid is sprayed, most of it mixes with the exfoliated cervical cells, with a small amount remaining in the vagina or cervical canal. The focus of the aspiration stage is to recover the high-concentration cell mixture (not all the rinsing fluid). Therefore, the initial volume does not need to be strictly equal to the final recovered volume. During the aspiration process, the separator 330 narrows the control channel, allowing the first aspirated low-concentration liquid (containing a small number of cells) to be stored in the primary sample mixing chamber a1, while the later aspirated high-concentration liquid (containing a large number of exfoliated cells) is guided to the high-concentration sample mixing chamber a2. This "stepwise recovery + layered storage" design ensures that although the volume of the final liquid used for testing may be smaller than the initial spray volume, the cell concentration is higher, meeting the core requirement of pathological testing for "concentration".

[0050] Based on the above, the specific structure will be disclosed in detail:

[0051] The operating component 200 includes a handle 210 fixedly connected to the end of the sampling rod body 100, the handle 210 being used to hold the sampling rod body 100;

[0052] In order for the piston assembly 300 to drive the flow of rinsing fluid in the primary sample mixing chamber a1 inside the sampling rod body 100, it is necessary to further disclose the parts of the piston assembly 300. Therefore, the piston assembly 300 includes a piston rod 310 slidably connected to the inner cavity of the sampling rod body 100, and a piston head 320 is fixedly connected to one end of the piston rod 310 near the sampling head 500. The rinsing fluid in the primary sample mixing chamber a1 can flow to the sampling head 500 by sliding the piston rod 310.

[0053] In order to prevent the rinsing fluid from flowing out of the sampling head 500 when the instrument moves, and to store the rinsing fluid in the primary sample mixing chamber a1, it is necessary to further disclose the parts of the separator 330. Therefore, the separator 330 includes a connecting rod 3301 fixedly connected to the end of the piston head 320, a baffle 3302 fixedly connected to the end of the connecting rod 3301 away from the piston head 320, and a fixing frame 3303 fixedly connected to the inner wall of the sampling rod body 100.

[0054] When the piston assembly 300 is in the initial position, the surface of the baffle 3302 is in close contact with the fixing frame 3303, and the two cooperate to form a limiting structure, which simultaneously cooperates with the piston head 320 to enclose the primary sample mixing chamber a1. When the piston assembly 300 is in the initial position, the baffle 3302 and the fixing frame 3303 are in close contact to form a sealing structure. The piston head 320, the connecting rod 3301, the baffle 3302 and the inner wall of the sampling rod body 100 together enclose the primary sample mixing chamber a1, ensuring stable storage of the irrigation fluid.

[0055] In order for the sampling head 500 to work with the piston assembly 300 to spray the irrigation fluid at a1, multiple sampling holes 501 are opened on the surface of the sampling head 500, and the sampling head 500 is semi-circular. The operation drive assembly 400 causes the piston rod 310 to drive the piston head 320 to move towards the semi-circular sampling head 500. The baffle 3302 separates from the fixing frame 3303, the cavity a1 opens the flow channel, the piston head 320 continues to move forward, and the irrigation fluid in the primary sample mixing cavity a1 is sprayed out in a scattering manner through the multiple sampling holes 501 opened on the surface of the sampling head 500 under pressure. The semi-circular sampling head 500 enables the irrigation fluid to evenly cover the cervical sampling area.

[0056] Meanwhile, the semi-circular sampling head 500 makes a "flexible contact" with the cervical region, rather than a rigid seal. When drawing back, it only generates suction on the local liquid, rather than acting directly on the cervical tissue, thus reducing the risk of mechanical damage to the cervix caused by negative pressure.

[0057] Spraying stage: The piston head 320 squeezes the primary sample mixing chamber a1, and the irrigation fluid is sprayed out through the sampling hole 501 under positive pressure. At this time, the hole diameter is designed to meet the "scattered spray" requirement, ensuring that the liquid evenly covers the cervical area and washes away the exfoliated cells.

[0058] During the aspiration phase: At the same time, the negative pressure generated by the rebound of the drive component 400 mainly acts on the irrigation fluid that has mixed cells in the uterine cavity, rather than directly "suctioning" the cervical tissue. Although the sampling hole 501 is small at this time, the liquid itself is fluid, and the separator 330 gradually narrows the channel during the aspiration process, so that the negative pressure of the primary sample mixing cavity a1 is concentrated on the liquid recovery, rather than the cervical surface. Therefore, aspiration can be completed without extreme negative pressure.

[0059] In order for the drive assembly 400 to drive the piston assembly 300 and the separator 330 to move, the end of the piston rod 310 away from the piston head 320 is connected to the drive assembly 400, and the drive assembly 400 is located in the inner cavity of the handle 210.

[0060] Sample reabsorption: Under the elastic rebound, the drive component 400 drives the piston head 320 to move in the opposite direction, forming a negative pressure at the sampling head 500. The liquid containing cells is reabsorbed through the sampling hole 501 into the high-concentration sample mixing chamber a2. The drive component 400 continues to rebound, and the piston component 300 and the separator 330 will continue to move, so that the liquid in the transition area a2 is quickly guided to the primary sample mixing chamber a1 for sample storage.

[0061] In order for the drive assembly 400 to drive the piston rod 310 to move, the drive assembly 400 includes a paddle 410 that slides in the inner cavity of the handle 210. A connecting frame 430 is fixedly connected to the surface of the paddle 410, and a damper 450 is fixedly connected to the surface of the connecting frame 430. The end of the connecting frame 430 away from the paddle 410 is fixedly connected to the piston rod 310. When the operator holds the handle 210, he pushes the paddle 410 to slide in the inner cavity of the handle 210 by applying force with his fingers. As the paddle 410 slides, the connecting frame 430 fixedly connected to it moves synchronously, converting the linear motion of the paddle 410 into traction on the piston rod 310, so that the piston rod 310 can slide synchronously and stably along the inner cavity of the sampling rod body 100.

[0062] In order to enable the operator to slide the paddle 410 inside the handle 210, an elongated hole 2101 is provided on the surface of the handle 210. The paddle 410 is slidably connected to the elongated hole 2101. An operating hole 2102 is provided between the paddle 410 and the elongated hole 2101. By inserting a finger into the operating hole 2102 and sliding the paddle 410 towards the elongated hole 2101, the connecting frame 430 and the piston rod 310 can be moved.

[0063] To ensure that the paddle 410 remains stable during sliding and moves along a preset trajectory, a slide rail 220 is fixedly connected to the bottom of the inner cavity of the handle 210, and a slider 420 is fixedly connected to the bottom of the paddle 410. The surface of the slider 420 slides on the inner wall of the slide rail 220. During the sliding of the paddle 410, the slider 420 at its bottom moves synchronously along the slide rail 220 inside the inner cavity of the handle 210. The linear constraint effectively limits the offset of the paddle 410, ensuring that it always slides along the preset straight trajectory and avoiding force transmission loss due to shaking.

[0064] In order for the damper 450 to restore the piston rod 310 to its initial position after sliding, a support frame 440 is fixedly connected to the bottom of the inner cavity of the handle 210. The inside of the support frame 440 is fixedly connected to the surface of the damper 450, and the output end of the damper 450 is fixedly connected to the surface of the connecting frame 430. When the connecting frame 430 moves with the paddle 410, the output end of the damper 450, which is fixedly connected to the connecting frame 430, moves synchronously, so that the damper 450 is compressed, thereby storing elastic potential energy inside the damper 450. After the sampling operation is completed, the operator releases his finger, and the damper 450 releases the stored elastic potential energy, which pushes the connecting frame 430 to move in the opposite direction through the output end. The connecting frame 430 drives the slider 420 at the bottom of the paddle 410 to slide in the opposite direction along the slide rail 220, so that the paddle 410, the connecting frame 430 and the piston rod 310 are reset together.

[0065] An end cap 600 is fitted onto the outer surface of the sampling head 500; by fitting the end cap 600 onto the surface of the sampling head 500, the liquid at points a2 and a1 inside the sampling rod body 100 can be further blocked to prevent it from flowing out.

[0066] In summary, the workflow of this invention is as follows:

[0067] like Figure 4 As shown, in the preparation stage: rinsing fluid is injected into the primary sample mixing chamber a1 beforehand. At this time, the piston assembly 300 and the separator 330 are in their initial positions. The piston head 320, connecting rod 3301, baffle 3302, and the inner wall of the sampling rod body 100 together enclose the closed space of the primary sample mixing chamber a1. The surface of the baffle 3302 is tightly fitted to the fixing frame 3303 to prevent leakage of rinsing fluid. The high-concentration sample mixing chamber a2 is in an empty state. An end cap 600 is fitted onto the outer surface of the sampling head 500 to further prevent liquid from flowing out of the primary sample mixing chamber a1 and the high-concentration sample mixing chamber a2, ensuring the cleanliness of the instruments.

[0068] like Figure 4 As shown, during the insertion stage: medical staff hold the handle 210 and insert the sampling rod body 100 and sampling head 500 into the patient's vagina. Since the diameter of the cylindrical structure of the sampling rod body 100 is significantly smaller than the unfolding size of the traditional dilator, it can naturally adapt to the human physiological structure and avoid compressing the vagina.

[0069] like Figure 5As shown, during the irrigation stage: medical staff insert their fingers into the operation hole 2102 inside the elongated hole 2101 on the surface of the handle 210, and push the lever 410 to slide along the slide rail 220 in the inner cavity of the handle 210. The lever 410 drives the connecting frame 430 and the piston rod 310 to move synchronously. The piston rod 310 drives the piston head 320 to move towards the semi-circular sampling head 500, so that the baffle 3302 is separated from the fixing frame 3303, opening the flow channel of the primary sample mixing chamber a1. The piston head 320 continues to move forward. Under pressure, the irrigation fluid in the primary sample mixing chamber a1 is sprayed out in a scattering manner through multiple sampling holes 501 on the surface of the sampling head 500. The semi-circular sampling head 500 ensures that the irrigation fluid evenly covers the cervical sampling area, flushes the cervical surface, and suspends the exfoliated cells in the liquid to form a low-concentration mixture.

[0070] like Figure 6 As shown, in the primary sampling stage: after irrigation is completed, the lever 410 is released, the damper 450 releases elastic potential energy, and pushes the connecting frame 430, lever 410 and piston rod 310 to move in the opposite direction, forming a negative pressure at the sampling head 500. The initially aspirated liquid containing irrigation fluid and cells flushed off first enters the high-concentration sample mixing chamber a2, and then continues to move with the piston assembly 300 and the separator 330, and is pushed into the primary sample mixing chamber a1 for storage. At this time, the separator 330 has not completely sealed the primary sample mixing chamber a1, and there is still a connection between the primary sample mixing chamber a1 and the high-concentration sample mixing chamber a2, but the main sample is stored in the primary sample mixing chamber a1.

[0071] like Figure 6 As shown, in the deep sampling and stratified sealing stage: the damper 450 continuously rebounds, the piston assembly 300 and the separator 330 continuously move in the opposite direction. At this time, the baffle 3302 gradually seals the piston assembly 300, so that the channel between the primary sample mixing chamber a1 and the high-concentration sample mixing chamber a2 gradually narrows. The continuous negative pressure suction draws in the deep cell mixture with a relatively high concentration. Most of the liquid containing more cells in the later stage stays in the high-concentration sample mixing chamber a2 for storage, realizing the stratified collection of samples with different concentrations.

[0072] like Figure 7 As shown, the sampling stage is completed: After sampling is completed, the end cap 600 on the outer surface of the sampling head 500 can further prevent sample leakage.

[0073] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely preferred examples and are not intended to limit the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A negative pressure elution cervical exfoliated cell sampler, comprising a sampling rod body (100), characterized in that: The sampling rod body (100) is a hollow cylindrical structure, with an operation component (200) at one end and a sampling head (500) at the other end away from the operation component (200). The inner cavity of the sampling rod body (100) is slidably provided with a piston assembly (300) and a separator (330), which together form a primary sample mixing chamber (a1) for storing rinsing fluid; The operating component (200) has a drive component (400) inside. The drive component (400) drives the piston component (300) and the separator (330) to slide synchronously by means of elasticity, so that the irrigation fluid of the primary sample mixing chamber (a1) region is sprayed into the cervical region through the sampling head (500). During the reabsorption process, the piston assembly (300) and the separator (330) slide synchronously in opposite directions during the elastic reset process of the drive assembly (400). The mixture is first aspirated into the primary sample mixing chamber (a1), and then the separator (330) gradually seals the primary sample mixing chamber (a1), allowing the subsequent high-concentration cell fluid to enter the high-concentration sample mixing chamber (a2), thus achieving sample stratification collection. The piston assembly (300) includes a piston rod (310) that is slidably connected to the inner cavity of the sampling rod body (100), and a piston head (320) is fixedly connected to one end of the piston rod (310) near the sampling head (500); The separator (330) includes a connecting rod (3301) fixedly connected to the end of the piston head (320), a baffle (3302) fixedly connected to the end of the connecting rod (3301) away from the piston head (320), and a fixing frame (3303) fixedly connected to the inner wall of the sampling rod body (100); When the piston assembly (300) is in the initial position, the surface of the baffle (3302) is in close contact with the fixing frame (3303), and the two cooperate to form a limiting structure, which simultaneously cooperates with the piston head (320) to enclose the primary sample mixing chamber (a1).

2. The negative pressure elution cervical exfoliated cell sampler according to claim 1, characterized in that: The operating component (200) includes a handle (210) fixedly connected to the end of the sampling rod body (100), the handle (210) being used to hold the sampling rod body (100).

3. The negative pressure elution cervical exfoliated cell sampler according to claim 1, characterized in that: The sampling head (500) has multiple sampling holes (501) on its surface, and the sampling head (500) is hemispherical.

4. The negative pressure elution cervical exfoliated cell sampler according to claim 1, characterized in that: The end of the piston rod (310) away from the piston head (320) is connected to the drive assembly (400), which is located inside the handle (210).

5. The negative pressure elution cervical exfoliated cell sampler according to claim 4, characterized in that: The drive assembly (400) includes a paddle (410) that slides in the inner cavity of the handle (210). A connecting frame (430) is fixedly connected to the surface of the paddle (410). A damper (450) is fixedly connected to the surface of the connecting frame (430). One end of the connecting frame (430) away from the paddle (410) is fixedly connected to the piston rod (310).

6. The negative pressure elution cervical exfoliated cell sampler according to claim 5, characterized in that: The handle (210) has an elongated hole (2101) on its surface. The elongated hole (2101) is slidably connected to the paddle (410). An operating hole (2102) is provided between the paddle (410) and the elongated hole (2101).

7. The negative pressure elution cervical exfoliated cell sampler according to claim 5, characterized in that: The bottom of the inner cavity of the handle (210) is fixedly connected to a slide rail (220), and the bottom of the paddle (410) is fixedly connected to a slider (420). The surface of the slider (420) slides on the inner wall of the slide rail (220).

8. The negative pressure elution cervical exfoliated cell sampler according to claim 5, characterized in that: A support frame (440) is fixedly connected to the bottom of the inner cavity of the handle (210). The inside of the support frame (440) is fixedly connected to the surface of the damper (450), and the output end of the damper (450) is fixedly connected to the surface of the connecting frame (430).

9. The negative pressure elution cervical exfoliated cell sampler according to claim 1, characterized in that: An end cap (600) is fitted onto the outer surface of the sampling head (500).

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