Semi-automatic negative pressure amniotic fluid puncture device

Abstract

The invention relates to the technical field of amniotic fluid puncture examination, and particularly discloses a semi-automatic negative-pressure amniotic fluid puncture device which comprises a B-ultrasonic probe and a puncture assembly, and a locking assembly is arranged on the B-ultrasonic probe; the locking assembly comprises a transverse plate, a bottom plate is fixedly connected to the bottom of the transverse plate, a limiting seat is fixedly connected to the top of the bottom plate, a through hole is formed in the limiting seat, and locking rotary knobs are symmetrically installed on the two sides of the through hole; through the design of the locking assembly and the puncture assembly, during amniotic fluid puncture inspection, after a puncture point is detected and determined by means of a B-mode ultrasound probe, a through hole in the top of a bottom plate limiting seat is accurately aligned with the puncture point by moving the B-mode ultrasound probe, clear and fixed path guidance is provided for puncture operation, and the positioning mode is combined with a subsequent locking mechanism, so that the puncture accuracy is improved. Position deviation caused by external factors in the puncture process can be effectively avoided, it is ensured that the puncture needle accurately reaches the target position, and the risk of mistakenly puncturing a fetus or an umbilical cord or a placenta is greatly reduced.

Description

Technical Field

[0001] This application belongs to the field of amniocentesis technology, specifically relating to a semi-automatic negative pressure amniocentesis device. Background Technology

[0002] Amniocentesis (also known as amniocentesis) is a prenatal diagnostic technique that involves puncturing the amniotic cavity within the pregnant woman's uterus to extract a small amount of amniotic fluid for testing. It is primarily used to screen for chromosomal abnormalities, genetic diseases, or other developmental abnormalities in the fetus. It is one of the important invasive examinations during pregnancy and is generally suitable for prenatal diagnosis in the mid-pregnancy stage. Amniotic fluid exists within the amniotic cavity; the amniotic cavity forms on the seventh day after fertilization, and amniotic fluid begins to be produced. At 12 weeks of gestation, the amniotic fluid volume is 50 ml; at 20 weeks, it is 400 ml; and at 36-38 weeks, it is 1000-1500 ml. The volume decreases slightly near the due date. The amniotic fluid contains epithelial cells shed from the fetus, which carry the fetus's complete genetic information. By performing karyotype analysis or gene chip detection on these cells, it is possible to accurately diagnose whether the fetus has numerical chromosomal abnormalities (such as trisomy 21, trisomy 18, trisomy 13, etc.) or structural abnormalities (such as chromosomal translocations, deletions, duplications, etc.).

[0003] Currently, amniocentesis typically uses a syringe connected to a puncture needle. During the procedure, a medical ultrasound probe is used to visualize the puncture site, which is then used to insert the needle into the amniotic cavity. The syringe is then pulled to extract amniotic fluid. However, in practice, the lack of precise mechanical positioning and fixation structures has led to a higher risk of the puncture point shifting due to ultrasound probe movement, the pregnant woman's breathing, or slight changes in position. This increases the likelihood of the needle accidentally entering the placenta, umbilical cord, or fetal area, thus increasing the probability of complications such as intraoperative bleeding and fetal injury. Summary of the Invention

[0004] The purpose of this application is to provide a semi-automatic negative pressure amniocentesis device to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, this application provides the following technical solution:

[0006] A semi-automatic negative pressure amniocentesis device includes:

[0007] Ultrasound probe and puncture assembly, wherein the ultrasound probe is equipped with a locking component;

[0008] The locking assembly includes a horizontal plate, which is installed at the bottom of the surface of the ultrasound probe. A base plate is fixedly connected to the bottom of the horizontal plate, and a limiting seat is fixedly connected to the top of the base plate. A through hole is provided on the limiting seat, and locking knobs are symmetrically installed on both sides of the through hole.

[0009] Preferably, the puncture assembly includes a vacuum packaging bag, inside which are disposed a puncture needle, a cannula, a collection tube, a miniature negative pressure pump, and multiple test tubes. A rubber stopper is installed on the top of the miniature negative pressure pump, an input tube is installed on one side of the top of the rubber stopper, and a pneumatic tube is installed on the other side of the top of the rubber stopper. A valve one is installed on the input tube, an output tube is installed at the bottom of one side of the collection tube, a valve two is installed on the output tube, and a plug is installed at the end of the output tube.

[0010] Preferably, the base plate is vertically disposed at the bottom of the horizontal plate, and the through hole penetrates the limiting seat and the base plate.

[0011] Preferably, the puncture needle is connected to the input tube via a flexible tube, and the flexible tube connects the pneumatic tube to the micro negative pressure pump.

[0012] Preferably, the bottom end of the input tube extends to the bottom of the inner side of the collection tube, and the end of the air pressure tube extends to the top of the inner side of the collection tube.

[0013] Preferably, the test tube is fitted with a collar, and the collar has a sealing film inside.

[0014] Preferably, the collection tube is provided with graduation lines, the size of the sleeve is adapted to the size of the through hole and the puncture needle, and the plug is inserted into the test tube.

[0015] Compared with the prior art, the beneficial effects of this application are:

[0016] (1) Through the design of the locking component and the puncture component, during amniocentesis, after the puncture point is determined by the ultrasound probe, the through hole at the top of the base plate limit seat is precisely aligned with the puncture point by moving the ultrasound probe, providing a clear and fixed path guide for the puncture operation. This positioning method, combined with the subsequent locking mechanism, can effectively avoid positional deviation caused by external factors during the puncture process, ensure that the puncture needle accurately reaches the target position, and greatly reduce the risk of accidentally puncturing the fetus, umbilical cord or placenta.

[0017] (2) The puncture needle and cannula are locked after insertion by using the locking knobs on both sides, which can securely fix the puncture needle and cannula. This design can effectively counteract possible interference such as hand tremors and slight changes in the pregnant woman's position during the operation, prevent the puncture needle from shaking or shifting during the aspiration of amniotic fluid, ensure the stability and continuity of the puncture operation, and reduce additional stimulation to the pregnant woman's abdominal tissue and fetus caused by instrument movement.

[0018] (3) The application of a micro negative pressure pump enables negative pressure collection of amniotic fluid, which creates negative pressure by drawing air from the collection tube. After opening valve one, the amniotic fluid can automatically flow into the collection tube through the puncture needle and inlet tube by means of pressure difference, eliminating the need for manual aspiration. This not only simplifies the operation steps but also avoids the problem of unstable amniotic fluid volume that may be caused by manual operation. After the aspiration is completed, the collection tube is pressurized by the micro negative pressure pump. Combined with the control of valve two and the connection between the output tube plug and the test tube, the amniotic fluid can flow into the test tube in an orderly manner, reducing leakage during the transfer of amniotic fluid, ensuring the accuracy of the sample volume, and reducing the risk of sample contamination.

[0019] (4) Through the design of the locking component and the puncture component, the operation process of medical staff is smoothly connected during amniocentesis. From positioning, puncture, locking to amniotic fluid collection and transfer, the steps are clear and easy to perform, reducing the tedious steps for medical staff in the operation process. At the same time, the locking mechanism does not require medical staff to continuously manually fix the instrument during the puncture process, reducing the operational burden of medical staff and allowing them to focus more on monitoring the fetal status and operation details, thereby improving the overall surgical efficiency and shortening the operation time. Attached Figure Description

[0020] Figure 1 This is a three-dimensional view of the rear side of the ultrasound probe in this application;

[0021] Figure 2 This is a frontal stereoscopic view of the ultrasound probe used in this application;

[0022] Figure 3 A perspective view of the locking component of this application;

[0023] Figure 4 This is a perspective view of the puncture component of this application;

[0024] Figure 5 This is a three-dimensional view of the collection tube used in this application;

[0025] Figure 6 This is a three-dimensional view of the test tube used in this application;

[0026] In the diagram: 1. Ultrasound probe; 2. Locking assembly; 21. Horizontal plate; 22. Base plate; 23. Limiting seat; 24. Through hole; 25. Locking knob; 3. Puncture assembly; 31. Vacuum packaging bag; 32. Puncture needle; 33. Cannula; 34. Collection tube; 35. Miniature negative pressure pump; 36. Test tube; 37. Scale line; 38. Rubber stopper; 39. Input tube; 310. Air pressure tube; 311. Valve one; 312. Output tube; 313. Valve two; 314. Plug; 315. Collar; 316. Sealing membrane. Detailed Implementation

[0027] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0028] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and 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, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," etc., 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. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0029] Example 1:

[0030] Please see Figure 1 , Figure 2 as well as Figure 3 As shown, a semi-automatic negative pressure amniocentesis device includes:

[0031] Ultrasound probe 1 and puncture assembly 3, with locking assembly 2 provided on ultrasound probe 1;

[0032] As can be seen from the above, when using it, the fetal position, gestational age, amniotic fluid volume, and placental position are determined by ultrasound probe 1 (avoiding the placental attachment site to reduce the risk of bleeding), and then puncture is performed through puncture component 3. Subsequently, it is locked by locking component 2, which facilitates the operation and allows for the extraction of amniotic fluid.

[0033] Specifically, regarding the aforementioned locking component 2, please refer to... Figure 2 and Figure 3 As shown, the locking component 2 includes a horizontal plate 21, which is installed at the bottom of the surface of the ultrasound probe 1. A base plate 22 is fixedly connected to the bottom of the horizontal plate 21, and a limiting seat 23 is fixedly connected to the top of the base plate 22. A through hole 24 is provided on the limiting seat 23, and locking knobs 25 are symmetrically installed on both sides of the through hole 24.

[0034] As can be seen from the above, when using this procedure, the pregnant woman lies on her back, the abdominal skin and locking component 2 are disinfected, a sterile towel is laid, and then the medical staff holds the ultrasound probe 1 to check the position of the fetus and placenta to determine the puncture point. At this time, the ultrasound probe 1 is moved to move the through hole 24 on the top of the upper limit seat 23 of the base plate 22 to the puncture point. Finally, the puncture operation is performed, and then the locking knobs 25 on both sides are turned to lock the puncture point, which facilitates the subsequent extraction of amniotic fluid.

[0035] Preferably, the base plate 22 is vertically disposed at the bottom of the horizontal plate 21, and the through hole 24 penetrates the limiting seat 23 and the base plate 22;

[0036] As can be seen from the above, the base plate 22 is vertically set at the bottom of the horizontal plate 21 so that the ultrasound probe 1 can be stably placed on the pregnant woman's abdomen after it is moved; the through hole 24 passes through the limiting seat 23 and the base plate 22 to facilitate subsequent puncture operations.

[0037] Example 2:

[0038] refer to Figure 4 , Figure 5 and Figure 6 As shown, the puncture assembly 3 includes a vacuum packaging bag 31. Inside the vacuum packaging bag 31 are a puncture needle 32, a cannula 33, a collection tube 34, a micro negative pressure pump 35, and multiple test tubes 36. A rubber stopper 38 is installed on the top of the micro negative pressure pump 35. An input tube 39 is installed on one side of the top of the rubber stopper 38, and a pneumatic tube 310 is installed on the other side of the top of the rubber stopper 38. A valve 311 is installed on the input tube 39. An output tube 312 is installed at the bottom of one side of the collection tube 34. A valve 313 is installed on the output tube 312, and a plug 314 is installed at the end of the output tube 312.

[0039] As can be seen from the above, during puncture, the cannula 33 is first inserted into the through hole 24, and then the puncture needle 32 is inserted into the pregnant woman's abdomen through the cannula 33. Subsequently, the miniature negative pressure pump 35 (the miniature negative pressure pump 35 is an existing technology product with a built-in power supply) is activated to extract air from the collection tube 34, making the collection tube 34 a negative pressure state. At this time, valve 1 311 is opened, allowing amniotic fluid to be injected into the collection tube 34 through the puncture needle 32 and the input tube 39. After the amniotic fluid is extracted, valve 1 311 is closed, and the collection tube 34 is pressurized by the miniature negative pressure pump 35. Then, the plug 314 at the end of the output tube 312 is inserted into the test tube 36, and then valve 2 313 is opened, allowing the amniotic fluid in the collection tube 34 to flow into the test tube 36.

[0040] Preferably, the puncture needle 32 is connected to the inlet tube 39 via a flexible tube, and the flexible tube connects the air pressure tube 310 to the miniature negative pressure pump 35.

[0041] As can be seen from the above, the amniotic fluid can be easily extracted through the puncture needle 32, the tubing and the inlet tube 39; the pressure inside the collection tube 34 can be easily controlled through the tubing, the air pressure tube 310 and the miniature negative pressure pump 35, thereby controlling the extraction and discharge of amniotic fluid.

[0042] Preferably, the bottom end of the input tube 39 extends to the bottom of the inner side of the collection tube 34, and the end of the air pressure tube 310 extends to the top of the inner side of the collection tube 34.

[0043] As can be seen from the above, extending the bottom of the inlet tube 39 to the bottom of the inner side of the collection tube 34 makes it easier to inject the extracted amniotic fluid into the collection tube 34; extending the end of the pressure tube 310 to the top of the inner side of the collection tube 34 prevents the amniotic fluid inside the collection tube 34 from flowing into the pressure tube 310.

[0044] Preferably, a collar 315 is installed on the test tube 36, and a sealing film 316 is provided inside the collar 315;

[0045] As can be seen from the above, the sealing film 316 is petal-shaped, which allows the plug 314 to be reset and sealed after insertion. The sealing film 316 inside the collar 315 ensures the airtightness and prevents the extracted amniotic fluid from being exposed to the air, thus preventing contamination of the extracted amniotic fluid.

[0046] Preferably, the collection tube 34 is provided with a scale line 37, the size of the sleeve 33 is adapted to the size of the through hole 24 and the puncture needle 32, and the plug 314 is inserted into the test tube 36.

[0047] As can be seen from the above, the scale line 37 on the collection tube 34 makes it easy to observe the volume of amniotic fluid drawn into the collection tube 34; the size of the cannula 33 is compatible with the size of the through hole 24 and the puncture needle 32, making it easy to insert the cannula 33 into the through hole 24 and also easy to insert the puncture needle 32 into the cannula 33; inserting the plug 314 into the test tube 36 makes it easy to inject the drawn amniotic fluid into the test tube 36 for subsequent testing.

[0048] Working principle: During puncture, the pregnant woman lies supine on the operating table. The abdominal skin, ultrasound probe 1, horizontal plate 21, base plate 22, limit seat 23, and through hole 24 are disinfected and a sterile drape is laid. Then, the medical staff holds the ultrasound probe 1 to check the position of the fetus and placenta to determine the puncture point. By moving the ultrasound probe 1, the through hole 24 at the top of the base plate 22 and the upper limit seat 23 is positioned at the puncture point. Then, the vacuum packaging bag 31 is opened, and the inner parts are taken out and assembled in sequence. At this time, the cannula 33 is placed inside the through hole 24, and the puncture needle 32 is inserted into the pregnant woman's abdomen from inside the cannula 33. Finally, the locking knobs 25 on both sides are used to lock the cannula 33, so that the inner cannula 33 locks the puncture needle 32 after puncture, preventing the puncture needle 32 from shifting.

[0049] The miniature negative pressure pump 35 is then activated to extract air from the collection tube 34, creating a negative pressure environment. At this point, valve 1 311 is opened, allowing amniotic fluid to be injected into the collection tube 34 through the puncture needle 32 and the inlet tube 39. After the amniotic fluid is extracted, valve 1 311 is closed, and the collection tube 34 is pressurized by the miniature negative pressure pump 35. Then, the plug 314 at the end of the outlet tube 312 is inserted into the test tube 36, and valve 2 313 is opened, allowing the amniotic fluid from the collection tube 34 to flow into the test tube 36.

[0050] Although embodiments of this application have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A semi-automatic negative pressure amniocentesis device, characterized in that, Include: B ultrasonic probe (1) and puncture assembly (3), the B ultrasonic probe (1) is equipped with locking assembly (2); The locking assembly (2) includes a horizontal plate (21), which is installed at the bottom of the B ultrasonic probe (1), and the bottom of the horizontal plate (21) is fixedly connected with a bottom plate (22), the top of the bottom plate (22) is fixedly connected with a limiting seat (23), the limiting seat (23) is provided with a through hole (24), and the through hole (24) is symmetrically provided with a locking knob (25) on both sides.

2. The semi-automated negative pressure amniocentesis device of claim 1, wherein: The puncture assembly (3) includes a vacuum packaging bag (31), the vacuum packaging bag (31) is provided with a puncture needle (32), a sleeve (33), a collection tube (34), a micro negative pressure pump (35) and a plurality of test tubes (36) inside, the micro negative pressure pump (35) is provided with a rubber plug (38) on the top, the rubber plug (38) is provided with an input pipe (39) on one side of the top, the rubber plug (38) is provided with an air pressure pipe (310) on the other side of the top, the input pipe (39) is provided with a valve (311), the collection tube (34) is provided with an output pipe (312) on one side of the bottom, the output pipe (312) is provided with a valve (313), and the output pipe (312) is provided with a plug (314) at the end.

3. The semi-automated negative pressure amniocentesis device of claim 1, wherein: The bottom plate (22) is vertically arranged at the bottom of the horizontal plate (21), and the through hole (24) penetrates the limiting seat (23) and the bottom plate (22).

4. The semi-automated negative pressure amniocentesis device of claim 2, wherein: The puncture needle (32) is connected with the input pipe (39) through a hose, and the hose connects the air pressure pipe (310) with the micro negative pressure pump (35).

5. The semi-automated negative pressure amniocentesis device of claim 2, wherein: The input pipe (39) extends to the inside bottom of the collection tube (34), and the air pressure pipe (310) extends to the inside top of the collection tube (34).

6. The semi-automated negative pressure amniocentesis device of claim 2, wherein: The test tube (36) is provided with a sleeve ring (315), and the sleeve ring (315) is provided with a sealing film (316) inside.

7. The semi-automated negative pressure amniocentesis device of claim 2, wherein: The collection tube (34) is provided with a scale line (37), the sleeve (33) is matched in size with the through hole (24) and the puncture needle (32), and the plug (314) is inserted into the test tube (36).

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