An amniotic fluid detection pad for premature rupture of membranes

Abstract

The present invention relates to the field of medical devices, and in particular to an amniotic fluid detection pad for premature rupture of membranes, comprising a pad body, wherein a water absorption layer, a dilution layer and an internal standard layer are sequentially arranged in the pad body from top to bottom; a first hollow cavity is arranged inside the dilution layer, a diluent is arranged in the first hollow cavity, a first isolation layer is detachably attached to the upper end of the first hollow cavity, and a second isolation layer is detachably attached to the lower end; a second hollow cavity is arranged inside the internal standard layer, and an internal standard liquid is arranged in the second hollow cavity; the first isolation layer is used to isolate the water absorption layer and the first hollow cavity, and the second isolation layer is used to isolate the first hollow cavity and the second hollow cavity. The present application can filter and collect liquid leaked by pregnant women in the late pregnancy, pretreat the subject's amniotic fluid with the diluent, and extract the diluted amniotic fluid with the internal standard liquid, thereby ensuring the purity of the extracted amniotic fluid and improving the accuracy of detection.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to an amniotic fluid detection pad for premature rupture of membranes. Background Art

[0002] For most pregnant women during natural childbirth, the amniotic membrane will rupture naturally when the cervix is ​​dilated more than 3 to 4 centimeters. However, for some pregnant women, the amniotic membrane ruptures before 37 weeks of pregnancy or before entering labor, causing amniotic fluid to flow out of the vagina. This situation is called "early rupture of membranes" or "premature rupture of membranes."

[0003] Currently, pH test paper pads and vaginal fluid smear microscopy are mainly used for detection. However, the urine of healthy people is weakly alkaline to weakly acidic, with a pH range of 4.8 to 7.4; vaginal secretions are acidic, with a pH range of 3.8 to 4.5, and may reach 6.5 during infection; amniotic fluid is neutral to weakly alkaline, with a pH range of 7.0 to 7.5; there is an overlapping area in the pH range of urine and amniotic fluid. It is obviously difficult to eliminate the interference of urine by using a single pH detection reagent on a sanitary pad close to the vaginal opening and urethral opening to detect whether the liquid is amniotic fluid, resulting in a high false positive rate for pH test paper pads, and the vaginal fluid smear microscopy is more complicated to operate. It is also affected by differences in the judgment of the testers, with a high rate of false negatives or false positives, and a low accuracy rate.

[0004] At the same time, because the larger uterus of pregnant women in the late pregnancy will compress the bladder, not only will the frequency of urination increase, but also stress urinary incontinence will easily occur. It is difficult for the pregnant woman herself to judge whether the vaginal discharge is amniotic fluid or urine, and the amniotic fluid leakage caused by premature rupture of membranes is often unconscious and cannot be controlled autonomously, making it difficult for doctors to take samples and conduct pathological tests in time, which can easily lead to missed diagnosis. Summary of the invention

[0005] In view of the above problems, the present invention proposes an amniotic fluid detection pad for premature rupture of membranes, specifically comprising a pad body, in which a water absorption layer 1, a dilution layer 2 and an inner standard layer 3 are arranged in sequence from top to bottom; a first hollow cavity 2-1 is arranged inside the dilution layer 2, and a diluent is arranged inside the first hollow cavity 2-1, a first isolation layer 4 is detachably attached to the upper end of the first hollow cavity 2-1, and a second isolation layer 5 is detachably attached to the lower end, a second hollow cavity 3-1 is arranged inside the inner standard layer 3, and an inner standard liquid is arranged inside the second hollow cavity 3-1; the first isolation layer 4 is used to isolate the water absorption layer 1 from the first hollow cavity 2-1, and the second isolation layer 5 is used to isolate the first hollow cavity 2-1 from the second hollow cavity 3-1.

[0006] Compared with the prior art, the advantages of the present invention are: the present application can filter and collect the fluid leaked by pregnant women in the late pregnancy, pre-treat the subject's amniotic fluid with a diluent, and extract the diluted amniotic fluid with an internal standard solution, thereby ensuring the purity of the extracted amniotic fluid and improving the accuracy of the detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 Shown is a schematic diagram of the structure of this application;

[0008] Figure 2 Shown is a schematic diagram of the adsorption layer structure of the present application;

[0009] Figure 3 Shown is a schematic diagram of the first hollow cavity structure of the present application.

[0010] Among them, 1, water absorption layer; 2, dilution layer; 2-1, first hollow cavity; 3, inner standard layer; 4, first isolation layer; 4-1, first transition layer; 4-2, first pull rod; 4-3, first pull ring; 5, second isolation layer; 5-1, third pull rod. DETAILED DESCRIPTION

[0011] In order to enable those skilled in the art to better understand the technical solution of the present application,

[0012] The drawings and preferred embodiments further illustrate the present invention in detail.

[0013] like Figures 1 to 3 As shown, the present invention proposes an amniotic fluid detection pad for premature rupture of membranes, which specifically includes a pad body, in which a water-absorbing layer 1, a dilution layer 2 and an internal standard layer 3 are sequentially arranged from top to bottom; the water-absorbing layer 1, the dilution layer 2 and the internal standard layer 3 are sequentially stacked together, and each layer is bonded together, the water-absorbing layer 1 includes a non-woven fabric surface layer, and a pure cotton inner absorption layer, and an adhesive sheet is provided on the upper end surface of the water-absorbing layer 1, which is used to make the pad body stick to the surface of the human body, so as to facilitate the timely collection of the fluid secreted by the pregnant woman.

[0014] A first hollow cavity 2-1 is provided inside the dilution layer 2, and a diluent is provided inside the first hollow cavity 2-1, and the diluent is a methanol and / or acetonitrile solution;

[0015] The first insulating layer 4 is detachably attached to the upper end of the first hollow cavity 2-1, and the second insulating layer 5 is detachably attached to the lower end. The first insulating layer 4 is used to isolate the water absorbing layer 1 and the first hollow cavity 2-1. The first insulating layer 4 is provided to ensure that the diluent can be stored in the first hollow cavity 2-1 when not being detected and adsorbed. The first insulating layer 4 is attached between the water absorbing layer 1 and the first hollow cavity 2-1, and a first transition layer 4-1 is provided at the end of one end of the first insulating layer 4. The first transition layer 4-1 is connected to a first pull rod 4-2, and a first pull ring 4-3 is provided at the end of the first pull rod 4-2.

[0016] like Figure 3 As shown, the first isolation layer 4 is adhered to the upper end surface of the first hollow cavity 2-1, which only isolates the water-absorbing layer 1 from the dilution layer 2. At the same time, the first transition layer 4-1, the first isolation layer 4 and the first pull ring 4-3 are an integral structure. The first transition layer 4-1 is bent at the upper end surface of the first isolation layer 4 by bending. The first pull ring 4-3 extends out of the outside of the pad body, and the two layers of the first transition layer 4-1 are not bonded to the first isolation layer 4 and the water-absorbing layer 1. The purpose is to facilitate the first pull ring 4-3 to pull the first isolation layer 4 out of the pad. After the first isolation layer 4 is pulled out of the pad, the diluent in the dilution layer 2 will merge with the liquid in the water-absorbing layer 1.

[0017] A second hollow cavity 3-1 is provided inside the internal standard layer 3, and an internal standard solution is provided inside the second hollow cavity 3-1; the internal standard solution is a solution containing internal standard substances deuterated glutamyl acid-d5 and deuterated glutamic acid-d5.

[0018] The second isolation layer 5 is used to isolate the first hollow cavity 2-1 and the second hollow cavity 3-1. At the same time, the second isolation layer 5 is provided to ensure that the diluent and the internal standard solution are not soluble on the basis of storing the internal standard solution in the second hollow cavity 3-1.

[0019] The second isolation layer 5 is attached between the first hollow cavity 2-1 and the second hollow cavity 3-1, and a second transition layer is provided at the end of one end of the second isolation layer 5, the second transition layer is connected to the second pull rod, and a third pull rod 5-1 is provided at the end of the second pull rod; the first railing 4-2 has the same structure as the second pull rod, and the first transition layer 4-1 has the same structure as the second transition layer. The first pull ring 4-3 is an annular hollow structure. The second isolation layer 5 is set in the same way as the first isolation layer 4, and is only used for liquid isolation, and the second isolation layer 5 is removed by pulling to merge the dilution layer and the inner standard layer liquid.

[0020] The following are some ways to use this application:

[0021] The first method is to stick the panty liner directly to the inside of the underwear. When the water-absorbing layer 1 absorbs a certain amount of liquid, the panty liner is removed from the pregnant woman, and the first isolation layer 4 is pulled to allow the liquid in the water-absorbing layer 1 and the dilution layer 2 to fully blend in the water-absorbing layer. The second isolation layer 5 is then pulled to allow the liquid in the internal standard layer 3 to fully blend in the water-absorbing layer. The liquid in the water-absorbing layer 1 is extracted, and the liquid is tested by liquid chromatography-mass spectrometry.

[0022] This method is suitable for pregnant women who have unconscious leakage in daily life and the leakage amount is small.

[0023] The second method is that when a pregnant woman excretes a large amount of fluid, the presence of amniotic fluid is detected by using an amniotic fluid detection PH test paper. If the color of the test paper changes, the first isolation layer 4 and the second isolation layer of the pad are pulled out through the first pull ring 4-3 and the third pull rod 5-1, and the fluid discharged by the pregnant woman is collected through the water absorption layer 1. The liquid in the water absorption layer 1 is extracted and tested by liquid chromatography-mass spectrometry.

[0024] This method is suitable for the detection and collection of amniotic fluid when pregnant women excrete a large amount of fluid. When pregnant women excrete a large amount of fluid, the urine is weakly alkaline and slightly acidic, with a pH range of 4.8 to 7.4; the vaginal secretions are acidic, with a pH range of 3.8 to 4.5, and may reach 6.5 during infection; the amniotic fluid is neutral and slightly alkaline, with a pH range of 7.0 to 7.5; there is an overlapping area in the pH range of urine and amniotic fluid, and it is not possible to detect whether the fluid is amniotic fluid only by a single pH detection reagent. Therefore, this method can collect the internal standard of the excreted fluid and detect the liquid by liquid chromatography-mass spectrometry after preliminarily determining whether there is amniotic fluid. This method can realize the centralized collection and storage of amniotic fluid and improve the accuracy of amniotic fluid detection.

[0025] After the internal standard solution is mixed with the excretion fluid, the protein is removed by centrifugal shaking to obtain the amniotic fluid extract. This application is only applicable to the calibration and sealing of the collected liquid, and is suitable for liquid chromatography-mass spectrometry detection.

[0026] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone can derive other various forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, all technical solutions that are the same or similar to the present invention are within the scope of protection.

Claims

1. An amniotic fluid detection pad for premature rupture of membranes, characterized in that: The protective pad comprises a pad body, wherein a water absorbing layer (1), a dilution layer (2) and an internal standard layer (3) are sequentially arranged in the pad body from top to bottom; a first hollow cavity (2-1) is arranged inside the dilution layer (2), a dilution liquid is arranged inside the first hollow cavity (2-1), a first isolation layer (4) is detachably attached to the upper end of the first hollow cavity (2-1), and a second isolation layer (5) is detachably attached to the lower end; a second hollow cavity (3-1) is arranged inside the internal standard layer (3), and an internal standard liquid is arranged inside the second hollow cavity (3-1); the first isolation layer (4) is used to isolate the water absorbing layer (1) from the first hollow cavity (2-1), and the second isolation layer (5) is used to isolate the first hollow cavity (2-1) from the second hollow cavity (3-1); The first isolation layer (4) is attached between the water absorbing layer (1) and the first hollow cavity (2-1), and a first transition layer (4-1) is provided at one end of the first isolation layer (4), the first transition layer (4-1) is connected to a first pull rod (4-2), and a first pull ring (4-3) is provided at the end of the first pull rod (4-2); The second isolation layer (5) is attached between the first hollow cavity (2-1) and the second hollow cavity (3-1), and a second transition layer is provided at the end of one end of the second isolation layer (5), the second transition layer is connected to a second tie rod, and a third tie rod (5-1) is provided at the end of the second tie rod; the first railing (4-2) and the second tie rod have the same structure, and the first transition layer (4-1) and the second transition layer have the same structure; When the water absorbing layer (1) absorbs a certain amount of liquid, the first isolation layer (4) is pulled to allow the liquids in the water absorbing layer (1) and the dilution layer (2) to be fully integrated into the water absorbing layer, and then the second isolation layer (5) is pulled to allow the liquid in the internal standard layer (3) to be fully integrated into the water absorbing layer, and the liquid in the water absorbing layer (1) is extracted and tested by liquid chromatography-mass spectrometry; The diluent is methanol and / or acetonitrile solution; The internal standard solution is a solution containing internal standard substances deuterated glutamyl acid-d5 and deuterated glutamic acid-d5.

2. The amniotic fluid detection pad for premature rupture of membranes according to claim 1, characterized in that: The first pull ring (4-3) is a hollow annular structure.

3. The amniotic fluid detection pad for premature rupture of membranes according to claim 1, characterized in that: The bottom surface is provided with a leak-proof membrane.

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