Amniotic fluid collection device and method of collecting amniotic fluid

Abstract

The present application belongs to the technical field of medical devices, and particularly relates to an amniotic fluid collecting device and an amniotic fluid collecting method. The amniotic fluid collecting device comprises a device main body, a sampling catheter and a pumping device, a sealed sterile inner cavity is arranged in the inside of a guide column at the first end of the device main body, a catheter outlet which can be opened and closed is arranged at the free end of the guide column, the two ends of the sampling catheter are respectively used for collecting amniotic fluid and being connected with the pumping device, and the amniotic fluid collecting device has a first state and a second state. When the amniotic fluid collecting device is in the first state, the first end of the sampling catheter is located in the sterile inner cavity, and the catheter outlet is closed. When the amniotic fluid collecting device is switched from the first state to the second state, the catheter outlet is opened, and the first end of the sampling catheter is extended out of the sterile inner cavity through the catheter outlet. In the present application, amniotic fluid can be collected without amniocentesis, so that the risk of amniocentesis can be avoided, and meanwhile, it can be ensured that the amniotic fluid is not contaminated during the collecting process.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to an amniotic fluid collection device and an amniotic fluid collection method. Background Technology

[0002] Premature rupture of membranes (PROM) complicates approximately 3% of pregnancies and leads to one-third of spontaneous preterm births. In up to half of all PROM cases, amniocentesis can confirm amniotic microbial invasion, particularly important for preterm fetuses. Amniocentesis can identify and rule out amniotic microbial invasion, allowing for the selection of a subgroup of women with PROM to consider safe interventions and prolong pregnancy, especially in preterm PROM patients. Preterm PROM is associated with high neonatal mortality and serious short- and long-term neonatal complications such as triatrial leukomalacia, bronchopulmonary dysplasia, necrotizing enterocolitis, and retinopathy of preterm death.

[0003] According to most international guidelines, preterm birth represents the majority of the risk for both the fetus and newborn in cases of premature rupture of membranes (PROM). Anticipatory management, in the absence of contraindications (such as infection, placental abruption, and umbilical cord complications), remains the most critical risk reduction strategy. The latency period following PROM, which lasts from hours to weeks, before the onset of labor, is a major predictor of both short-term and long-term neonatal outcomes. The latency period provides an opportunity to implement risk-reduction interventions before birth, such as prenatal corticosteroids and broad-spectrum antimicrobial regimens. Another management approach is targeted antibiotic therapy based on the most common microorganisms isolated from the amniotic fluid to maximize the effectiveness of the antibiotic, prevent antibiotic resistance, and potentially reduce the risk of overlapping infections associated with prolonged treatment and changes in the vaginal microbiota.

[0004] Amniotic microbial invasion can often be diagnosed in the subclinical stage of infection, meaning it is diagnosed in the absence of typical signs of overt infection (fever, fetal tachycardia, uterine tenderness, and purulent discharge). Therefore, amniocentesis with amniocentesis culture remains the most specific method for detecting infection and inflammation in the amniotic fluid. Furthermore, it may be beneficial to select a subgroup of patients with shorter incubation periods and higher perinatal mortality and morbidity for personalized interventions, including targeted antimicrobial therapy, continuous amniocentesis to verify treatment effectiveness, and early induction to reduce fetal exposure to infection.

[0005] Studies have found that determining whether amniotic microbial invasion has occurred through amniocentesis and then providing individualized treatment to patients can prolong pregnancy, reduce preterm births before 32 weeks of gestation, reduce the need for neonatal support, reduce neonatal intensive care unit hospitalizations, and does not increase the incidence of histological chorioamnionitis, chorioamnionitis, neonatal infection-related morbidity, or short-term adverse maternal and neonatal outcomes.

[0006] However, considering the invasiveness of amniocentesis and the potential for technical difficulties (such as severe oligohydramnios, placenta located on the anterior uterine wall, etc.) or fetal vascular injury, approximately 40% of cases refuse or cannot undergo amniocentesis for microbial invasion assessment. Another 9% of cases require two amniocentesis attempts. Therefore, there is an urgent need for a device and method to collect amniotic fluid from patients with premature rupture of membranes without the need for amniocentesis. Summary of the Invention

[0007] This invention provides an amniotic fluid collection device and method that can collect amniotic fluid from patients with premature rupture of membranes without the need for amniocentesis, thereby solving the technical problem that patients may refuse or be unable to undergo amniocentesis assessment due to the risks of amniocentesis.

[0008] A first aspect of the present invention provides an amniotic fluid collection device, comprising: a device body, a sampling catheter, and an extraction device.

[0009] The first end of the main body of the device is provided with a guide post for insertion into the cervix. The guide post has a sealed sterile inner cavity, and the free end of the guide post has an openable and closable catheter outlet connected to the sterile inner cavity.

[0010] The first end of the sampling catheter is used to collect amniotic fluid. The first end of the sampling catheter is inserted into the sterile lumen from the second end of the device body, which is opposite to the first end. The second end of the sampling catheter is used for a detachable and sealed connection with the extraction device.

[0011] The amniotic fluid collection device has a first state and a second state.

[0012] When the amniotic fluid collection device is in the first state, the first end of the sampling catheter is located in the sterile lumen and the catheter outlet is closed; when the amniotic fluid collection device switches from the first state to the second state, the catheter outlet is opened and the first end of the sampling catheter extends out from the sterile lumen through the catheter outlet.

[0013] In one embodiment, it further includes: a sealing valve plate,

[0014] When the amniotic fluid collection device is in the first state, the sealing valve plate closes the catheter outlet; when the amniotic fluid collection device switches from the first state to the second state, the sealing valve plate moves away from the catheter outlet until the catheter outlet is opened.

[0015] In one embodiment, an operating key for controlling the sealing valve plate is provided at the second end of the main body of the device.

[0016] The operating key is connected to the sealing valve plate via a flexible pull rod. The first end of the flexible pull rod is connected to the operating key, and the second end of the flexible pull rod extends from the second end of the device body into the sterile inner cavity and is connected to the sealing valve plate.

[0017] When the amniotic fluid collection device is in the first state, the operation key is in the initial position;

[0018] Specifically, pulling the operation key in the initial position causes the flexible lever to move the sealing valve plate away from the conduit outlet until the conduit outlet is opened.

[0019] In one embodiment, the first end of the sampling catheter is provided with a sampling head made of soft material, and the sampling head is configured in a trumpet shape.

[0020] In one embodiment, a sealing plug is provided at the second end of the sampling catheter, and the sealing plug is detachably inserted into the second end of the sampling catheter.

[0021] In one embodiment, it further includes: a hose reel,

[0022] The hose reel includes: an inner hose reel and an outer hose reel.

[0023] An operating wheel is provided at the first end of the outer tube. The inner tube is inserted into the interior of the outer tube from the second end. The sampling guide is wound around the outer wall of the outer tube.

[0024] The operation wheel can be rotated to drive the outer cylinder of the tube to rotate relative to the inner cylinder of the tube.

[0025] In one embodiment, it further includes: operating a protective sleeve.

[0026] The interior of the operating protective sleeve is a sterile environment. One end of the operating protective sleeve is sealed to the outer peripheral wall of the second end of the device body, and the other end is provided with an openable and closable opening.

[0027] The extraction device and the corresponding part of the sampling catheter are disposed inside the operating protective sleeve.

[0028] In one embodiment, the guide post is made of a soft, elastic material.

[0029] In one embodiment, the outer walls of both the main body of the device and the guide column are covered with medical disinfection and sterilization material.

[0030] The second method of the present invention provides an amniotic fluid collection method, which uses the amniotic fluid collection device described above to collect amniotic fluid from a target cavity, and includes the following steps:

[0031] With the free end of the guide column of the amniotic fluid collection device in its first state facing the target patient, the guide column is pushed into the target patient's vagina through the main body of the amniotic fluid collection device until the free end of the guide column reaches the internal os of the cervix; and

[0032] Open the catheter outlet, allowing the first end of the sampling catheter to extend a predetermined length from the sterile lumen through the catheter outlet, thereby switching the amniotic fluid collection device from the first state to the second state; and

[0033] After sealing the second end of the sampling catheter to the extraction device, amniotic fluid from the uterine cavity of the target patient is collected through the extraction device.

[0034] Compared with existing technologies, the advantages of this invention are as follows: In this invention, the first end of the sampling catheter is the sampling port, which extends to the internal os of the cervix to collect amniotic fluid from the uterine cavity of the target patient, eliminating the need for amniocentesis. This solves the technical problem of patients refusing or being unable to undergo amniotic cavity microbial invasion assessment due to the risks of amniocentesis. Simultaneously, by setting a guide column with a sterile inner lumen, the first end of the sampling catheter remains within a sealed sterile lumen until it reaches the internal os of the cervix, preventing contamination of the first end of the sampling catheter by bacteria from the external environment, vagina, and cervix. This, in turn, avoids contamination of the collected amniotic fluid and ensures the accuracy of the amniotic cavity microbial invasion assessment results. Attached Figure Description

[0035] The invention will now be described in more detail with reference to embodiments and the accompanying drawings.

[0036] Figure 1 This is a schematic diagram of the structure of an amniotic fluid collection device according to one embodiment of the present invention;

[0037] Figure 2 This is a partially enlarged schematic diagram of the free end of the guide column of the amniotic fluid collection device in the first state according to an embodiment of the present invention.

[0038] Figure 3 This is a partially enlarged schematic diagram of the free end of the guide column of the amniotic fluid collection device in the second state according to an embodiment of the present invention.

[0039] Figure 4 This is a schematic diagram of the structure of a tube reel in one embodiment of the present invention;

[0040] Figure 5 This is an axial cross-sectional view of a hose reel in one embodiment of the present invention;

[0041] Figure 6 This is a left view of a tube reel in one embodiment of the present invention;

[0042] Figure 7 This is a flowchart of the amniotic fluid collection method of the present invention.

[0043] Figure label:

[0044] 1. Main body of the device; 2. Sampling conduit; 3. Extraction device;

[0045] 4. Sealing valve plate; 5. Operating key; 6. Flexible pull rod;

[0046] 7. Tube reel; 8. Medical disinfection and sterilization materials; 9. Operating protective sleeves;

[0047] 11. Guide column; 111. Sterile lumen; 112. Catheter exit point;

[0048] 21. Sampling head; 22. First graduation; 23. Sealing plug;

[0049] 71. Inner cylinder of the coiled tube; 72. Outer cylinder of the coiled tube; 73. Operating wheel. Detailed Implementation

[0050] The present invention will now be further described with reference to the accompanying drawings. It should be noted that, as long as there is no conflict, the various embodiments and features of the present invention can be combined with each other, and the resulting technical solutions are all within the protection scope of the present invention.

[0051] like Figure 1-6As shown, the amniotic fluid collection device of the present invention includes: a device body 1, a sampling catheter 2, and an extraction device 3. The first end of the device body 1 is provided with a guide post 13 for insertion into the cervix. The guide post 13 has a sealed sterile inner cavity 111 inside. The first end of the device body 1 is provided with an openable and closable catheter outlet 112 connected to the sterile inner cavity 111. The first end of the sampling catheter 2 is used to collect amniotic fluid. The first end of the sampling catheter 2 is inserted into the sterile inner cavity 111 from the second end of the device body 1 opposite to the first end. The second end of the sampling catheter 2 is connected to the extraction device 3. The amniotic fluid collection device has a first state and a second state. When the amniotic fluid collection device is in the first state, the first end of the sampling catheter 2 is located in the sterile inner cavity 111, and the catheter outlet 112 is closed. When the amniotic fluid collection device switches from the first state to the second state, the catheter outlet 112 is opened, and the first end of the sampling catheter 2 extends out from the sterile inner cavity 111 through the catheter outlet 112.

[0052] In this invention, the first end of the sampling catheter 2 serves as the sampling port, which extends to the internal os of the cervix to collect amniotic fluid from the uterine cavity of the target patient. Amniocentesis is unnecessary, thus solving the technical problem of patients refusing or being unable to undergo amniotic cavity microbial invasion assessment due to the risks associated with amniocentesis. Simultaneously, by incorporating a guide post with a sterile inner lumen 111, the first end of the sampling catheter 2 remains within the sealed sterile inner lumen 111 until it reaches the internal os of the cervix. This prevents contamination of the first end of the sampling catheter 2 by bacteria from the external environment, vagina, and cervix, thereby avoiding contamination of the collected amniotic fluid and ensuring the accuracy of the amniotic cavity microbial invasion assessment results.

[0053] In other words, the first state of the amniotic fluid collection device is its initial state, and the second state of the amniotic fluid collection device is its state when amniotic fluid is collected.

[0054] It should be noted that the end of the guide post 13 that is not connected to the main body 1 of the device is its free end.

[0055] Specifically, the amniotic fluid collection device also includes a sealing valve. The sealing valve is located at the catheter outlet 112 to control the opening and closing of the catheter outlet 112.

[0056] In one embodiment, the sealing valve is configured as a sealing valve plate 4. When the amniotic fluid collection device is in the first state, the sealing valve plate 4 closes the catheter outlet 112; when the amniotic fluid collection device switches from the first state to the second state, the sealing valve plate 4 moves away from the catheter outlet 112 until the catheter outlet 112 is opened.

[0057] Specifically, the second end of the device body 1 is provided with an operation key 5 for controlling the sealing valve plate 4. The operation key 5 is connected to the sealing valve plate 4 through a flexible pull rod 6. The first end of the flexible pull rod 6 is connected to the operation key 5, and the second end of the flexible pull rod 6 extends from the second end of the device body 1 into the sterile inner cavity 111 and is connected to the sealing valve plate 4. When the amniotic fluid collection device is in the first state, the operation key 5 is in the initial position.

[0058] like Figure 2 As shown, when the amniotic fluid collection device is in the first state, the sealing valve plate 4 closes the catheter outlet 112.

[0059] Specifically, pulling the operation key 5, which is in its initial position, causes the flexible pull rod 6 to move the sealing valve plate 4 away from the conduit outlet 112, thereby opening the conduit outlet 112. Figure 3 As shown, this allows the first end of the sampling catheter 2 to extend from the sterile lumen 111 through the catheter outlet 112.

[0060] It should be noted that, due to the size limitations of the sterile inner cavity 111, the sealing valve plate 4 needs to have a certain degree of flexibility and be able to bend in order to open the catheter outlet 112; the flexible pull rod 6 also needs to have a certain degree of rigidity in order to drive the reciprocating movement of the sealing valve plate 4.

[0061] In addition, when the operation key 5 is pressed to return it to its initial position, the flexible pull rod 6 drives the sealing valve plate 4 to move radially toward the conduit outlet 112 along the main body 1 of the device to open the conduit outlet 112.

[0062] The guide post 11 has an arc-shaped chamfer between its free end face and its outer peripheral wall to avoid injury to the patient.

[0063] Specifically, the diameter of the guide post 11 is set to 0.4cm to 0.8cm, and the axial length is set to 4cm to 5cm to match the cervix.

[0064] Preferably, the diameter of the device body 1 is larger than the diameter of the guide post, for example, it can be set to 3cm to 4cm, and the axial length is set to 10cm to 12cm, so as to facilitate gripping.

[0065] In one embodiment, the first end of the sampling catheter 2 is provided with a sampling head 21 made of soft material, and the sampling head 21 is configured in a trumpet shape.

[0066] The funnel-shaped sampling head 21 has a large opening, which facilitates the collection of amniotic fluid and avoids amniotic fluid blockage. At the same time, the sampling head 21 is made of soft material, such as soft plastic, to avoid damage to the fetal membranes and uterine cavity.

[0067] Preferably, a sealing plug 23 is provided at the second end of the sampling catheter 2, and the sealing plug 23 is detachably inserted into the second end of the sampling catheter 2.

[0068] Preferably, a first scale 22 is provided on the outer wall of the second end of the sampling catheter 2 near the main body 1 of the device, so that the operator can obtain the length of the sampling head 21 extending out of the catheter outlet 112.

[0069] like Figure 1-2 As shown, the amniotic fluid collection device also includes a tubing reel 7. The tubing reel 7 includes an inner tubing 71 and an outer tubing 72. An operating wheel 73 is provided at the first end of the outer tubing 72. The inner tubing 71 is inserted into the interior of the outer tubing 72 from the second end of the outer tubing 72. The sampling catheter 2 is wound around the outer wall of the outer tubing 72. The outer tubing 72 can be rotated relative to the inner tubing 71 by rotating the operating wheel 73.

[0070] The sampling conduit 2 is housed on the outer tube 7271 of the tube reel 7 to prevent the sampling conduit 2 from getting tangled. At the same time, the outer tube 72 can be rotated by the operating wheel 73, thereby enabling the sampling conduit 2 to be stretched and contracted.

[0071] In use, the operator inserts one finger (e.g., index finger) into the inner tube 71 of the tube to fix the inner tube 71 to the finger, and then uses another finger (e.g., thumb) to turn the operating wheel 73 to rotate the outer tube 72 of the tube, so that the operator can operate it alone to stretch and retract the sampling catheter 2, and to extend or retract the sampling head 21 of the sampling catheter 2 from the catheter outlet 11212.

[0072] Specifically, the sampling catheter 2 is also made of a soft material, such as soft plastic, so that it can be easily wound onto the reel of the tubing reel 7.

[0073] In one embodiment, the guide post 11 is made of a soft, elastic material, such as medical-grade silicone rubber. This prevents damage to the cervix during insertion of the guide post 11.

[0074] In addition, the main body 1 of the device can be made of a soft, elastic material or a hard material, such as plastic, to facilitate gripping.

[0075] In one embodiment, both the outer walls of the device body 1 and the guide post 11 are covered with medical disinfectant material 8. This allows for disinfection and sterilization of the vagina and cervix as the free end of the guide post reaches the internal os of the cervix.

[0076] The aforementioned medical disinfection and sterilization material 8 can be a medical cotton layer coated with iodine.

[0077] In one embodiment, such as Figure 1 As shown, the extraction device 3 can be a syringe (excluding the needle).

[0078] Specifically, the extraction device 3 includes a collection cylinder and a piston rod. The collection cylinder has a collection chamber and a suction port communicating with the collection chamber. The suction port is sealed and communicated with the second end of the sampling conduit 2. The piston end of the piston rod is located in the collection chamber, wherein the movement of the piston rod is used to extract amniotic fluid into the collection chamber.

[0079] Specifically, the second end of the sampling catheter 2 is detachably and sealed to the liquid extraction port via a rubber tube. The two ends of the rubber tube are respectively fitted onto the second end of the sampling catheter 2 and the liquid extraction port.

[0080] Preferably, a second scale is provided on the outer wall of the collection tube to measure the volume of the collected amniotic fluid.

[0081] In one embodiment, the amniotic fluid collection device further includes an operating protective sleeve 9, the interior of which is a sterile environment. One end of the operating protective sleeve 9 is sealed to the outer peripheral wall of the second end of the device body 1, and the other end is provided with an openable and closable opening. The corresponding parts of the extraction device 3 and the sampling catheter 2 are disposed inside the operating protective sleeve 9.

[0082] In this embodiment, during the amniotic fluid collection operation, after the guide column 11 is pushed into the cervix through the main body 1 of the device, the opening of the operation protective sleeve 9 is opened, so that the sampling catheter 2 is pushed and the sampling catheter 2 is connected to the extraction device 3 through the operation protective sleeve 9, so as to avoid the amniotic fluid collection being contaminated.

[0083] In practice, the extraction device 3 and the portion of the sampling conduit 2 located outside the main body 1 of the device, as well as the tube reel 7, are all sealed and stored in the operating protective sleeve 9.

[0084] Specifically, the protective cover 9 can be made of transparent plastic material.

[0085] like Figure 7 As shown, a second aspect of the present invention also provides a method for amniotic fluid collection, which uses the amniotic fluid collection device described above to collect amniotic fluid from a target cavity, comprising the following steps:

[0086] Step 1: Position the free end of the guide column 1 of the amniotic fluid collection device in the first state toward the target patient, and push the guide column 11 into the vagina of the target patient with the main body 1 of the amniotic fluid collection device until the free end of the guide column 1 reaches the internal os of the cervix.

[0087] Step 2: Open the catheter outlet 112, so that the first end of the sampling catheter 2 extends from the sterile inner cavity 111 through the catheter outlet 112 to a predetermined length, thereby switching the amniotic fluid collection device from the first state to the second state.

[0088] Step 3: After sealing the second end of the sampling catheter 2 to the extraction device 3, amniotic fluid from the uterine cavity of the target patient is collected through the extraction device 3.

[0089] In step 3, first open the sealing plug 23 at the second end of the sampling tube 2, and then seal the second end of the sampling tube 2 to the liquid extraction port of the extraction device 3.

[0090] In this invention, the first end of the sampling catheter 2 serves as the sampling port, which extends to the internal os of the cervix to collect amniotic fluid from the uterine cavity of the target patient. Amniocentesis is unnecessary, thus solving the technical problem of patients refusing or being unable to undergo amniotic cavity microbial invasion assessment due to the risks associated with amniocentesis. Simultaneously, by incorporating a guide post 11 with a sterile inner cavity 111, the first end of the sampling catheter 2 remains within the sealed sterile inner cavity 111 until it reaches the internal os of the cervix. This prevents contamination of the first end of the sampling catheter 2 by bacteria from the external environment, vagina, and cervix, thereby avoiding contamination of the collected amniotic fluid and ensuring the accuracy of the amniotic cavity microbial invasion assessment results.

[0091] It should be noted that the target patients mentioned above are those with premature rupture of membranes (PROM). When the membranes of a patient with PROM rupture, the amniotic fluid inside the membranes will flow out into the uterine cavity through the rupture.

[0092] In addition, before step 1, the above method requires further treatment of the vagina and cervix. First, use a speculum to open the vagina and collect vaginal secretions; then, expose the cervix and disinfect it twice with cotton swabs, once from the outside in and once from the inside out. Next, disinfect the cervical canal twice with iodine swabs.

[0093] 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; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0094] In this invention, the terms "inner" and "outer" refer to the inner and outer contours relative to the outlines of each component itself. These terms are used merely for clarity and are not intended to limit the scope of the invention. Changes or adjustments to these relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first" and "second" may explicitly or implicitly include one or more of that feature.

[0095] Although the invention has been described with reference to preferred embodiments, various modifications can be made and components can be replaced with equivalents without departing from the scope of the invention. In particular, the technical features mentioned in the various embodiments can be combined in any manner as long as there is no structural conflict. The invention is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. An amniotic fluid collection device, characterized in that, include: The device consists of the main body, sealing valve, hose reel, sampling conduit, and extraction device. The first end of the main body of the device is provided with a guide post for insertion into the cervix. The guide post has a sealed sterile inner cavity inside. The free end of the guide post is provided with an openable and closable catheter outlet connected to the sterile inner cavity. The guide post is made of soft elastic material. The first end of the sampling catheter is provided with a sampling head made of soft material. The sampling head is shaped like a trumpet. The first end of the sampling catheter is used to collect amniotic fluid. The first end of the sampling catheter is inserted into the sterile inner cavity from the second end of the main body of the device, which is opposite to the first end. The second end of the sampling catheter is used to be detachably and sealed to the extraction device. A first scale is provided on the outer wall of the tube section at the second end of the sampling catheter to facilitate the operator to obtain the length of the sampling head extending out of the catheter outlet. The amniotic fluid collection device has a first state and a second state. When the amniotic fluid collection device is in the first state, the first end of the sampling catheter is located in the sterile lumen, and the catheter outlet is closed. When the amniotic fluid collection device switches from the first state to the second state, the catheter outlet is opened, and the first end of the sampling catheter extends out from the sterile lumen through the catheter outlet. The sealing valve can be bent to open the catheter outlet. When the amniotic fluid collection device is in the first state, the sealing valve closes the catheter outlet; when the amniotic fluid collection device switches from the first state to the second state, the sealing valve moves away from the catheter outlet until the catheter outlet is opened; the second end of the device body is provided with an operation key for controlling the sealing valve, the operation key is connected to the sealing valve via a flexible rod, the first end of the flexible rod is connected to the operation key, and the second end of the flexible rod extends from the second end of the device body into the sterile inner cavity and is connected to the sealing valve; when the amniotic fluid collection device is in the first state, the operation key is in the initial position; wherein, pulling the operation key in the initial position causes the flexible rod to move the sealing valve away from the catheter outlet until the catheter outlet is opened; The tube reel includes an inner tube and an outer tube. An operating wheel is provided at the first end of the outer tube. The inner tube is inserted into the interior of the outer tube from the second end of the outer tube. The sampling conduit is wound around the outer wall of the outer tube. The outer tube can be rotated relative to the inner tube by rotating the operating wheel.

2. The amniotic fluid collection device according to claim 1, characterized in that, The second end of the sampling catheter is provided with a sealing plug, which is detachably inserted into the second end of the sampling catheter.

3. The amniotic fluid collection device according to any one of claims 1-2, characterized in that, Also includes: Operating the protective cover The interior of the operating protective sleeve is a sterile environment. One end of the operating protective sleeve is sealed to the outer peripheral wall of the second end of the device body, and the other end is provided with an openable and closable opening. The extraction device and the corresponding part of the sampling catheter are disposed inside the operating protective sleeve.

4. The amniotic fluid collection device according to any one of claims 1-2, characterized in that, The outer walls of both the main body of the device and the guide column are covered with medical disinfection and sterilization materials.

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