CN108542596A - Premature rupture of fetal membranes detects protection pad - Google Patents

Premature rupture of fetal membranes detects protection pad Download PDF

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Publication number
CN108542596A
CN108542596A CN201810291342.1A CN201810291342A CN108542596A CN 108542596 A CN108542596 A CN 108542596A CN 201810291342 A CN201810291342 A CN 201810291342A CN 108542596 A CN108542596 A CN 108542596A
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creatinine
indicators
protection pad
reagent
fetal membranes
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CN201810291342.1A
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Chinese (zh)
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顾勍
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Individual
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Individual
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Priority to CN201810291342.1A priority Critical patent/CN108542596A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/45Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the shape
    • A61F13/47Sanitary towels, incontinence pads or napkins
    • A61F13/472Sanitary towels, incontinence pads or napkins specially adapted for female use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G01N21/80Indicating pH value
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/70Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving creatine or creatinine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • A61F2013/422Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm the alarm being a colour change
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • A61F2013/427Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm pH indicator

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Vascular Medicine (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Food Science & Technology (AREA)
  • Plasma & Fusion (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The present invention relates to a kind of prematures rupture of fetal membranes to detect protection pad, isolation permeable formation, the detection layers of middle layer and the absorbed layer of lower layer including upper layer, detection layers contain pH indicators and creatinine detection reagent, pH indicators and creatinine detection reagent are fixed on absorbed layer by hydrophilic carrier spaced reciprocally respectively, the color range of pH indicators is pH >=6.5, and the detection threshold value of creatinine detection reagent is 5~40mg/dl.The present invention using pH indicators and the bigeminy reagent of creatinine detection reagent synchronize be detected, specificity is high, effectively excludes interference of the general urine to detection, improves accuracy detect to amniotic fluid, to reduce the probability for detecting false positive.

Description

Premature rupture of fetal membranes detects protection pad
Technical field
The invention belongs to the technical fields of amniotic fluid detection, and protection pad is detected more particularly to a kind of premature rupture of fetal membranes.
Background technology
Amniorrhexis, amniotic fluid are flowed out by vagina, referred to as " one's water breaks ".Most puerperas tire after ostium of uterus opens big 3~4 centimetres Film can Natural Ruptures, this belongs to normal condition;But if all numbers of pregnancy are less than 37 weeks, or before actually entering stages of labor, amnion With regard to Natural Ruptures, and amniotic fluid is caused to be flowed out by vagina, is known as " early stage one's water breaks " or " premature rupture of fetal membranes ".Premature rupture of fetal membranes is to enclose the raw phase most Common complication can cause early yield to increase, and perinatal feruses case fatality rate increases, and intrauterine infection rate and puerperal infection rate increase.
Although clinically finding that premature rupture of fetal membranes has great importance as early as possible, pregnant woman herself is difficult to sentence in some cases Disconnected is amniotic fluid or urine.Clinically leakage of amniotic fluid caused by premature rupture of fetal membranes is unconscious, cannot be controlled;And pregnant late period, portion Divide pregnant woman not only number of micturitions increases, or even stress incontinence can also occur because developmental fetus oppresses bladder.Therefore, There is an urgent need to develop it is a kind of can in real time and accurate measurements premature rupture of fetal membranes product, in time, accurate judgement lower body outflow liquid Body is amniotic fluid, for early diagnosing premature rupture of fetal membranes, reduces pregnant woman and fetus risk is extremely important.
The use of the amniotic fluid monitoring sanitary belt that can be dressed is a relatively good selection, city from the promptness of detection Also occur some amniotic fluid detection protection pads on field, and have multiple patents (CN206044839U, CN105277656A, CN203089311U, CN204636718U, CN201752403U, CN104297241A, CN101813702B, CN204154653U).The premature rupture of fetal membranes detecting pad (method) that these patents are told about, mainly include panty liner, permeable formation and PH test paper forms.The cardinal principle of detection is to use acid-base indicator according to the difference of the pH of urine, vaginal fluid and amniotic fluid Colour developing is to determine whether be amniotic fluid.But healthy population urine neutrality meta-acid, pH value range 4.8-7.4;Vaginal fluid is inclined Acid, pH value, may be to 6.5 in infection in 3.8-4.5;Amniotic fluid neutrality meta-alkali, pH ranging from 7.0-7.5;Urine and amniotic fluid PH value range, which exists, intersects, and is to detect liquid by the single pH detection reagents of the panty liner close to introitus, urethral orifice No is amniotic fluid, it is difficult to exclude the interference of urine.
Creatinine is product of the muscle in human body metabolism, and 1mg creatinines can be generated per 20g muscle metabolisms.Creatinine is mainly by kidney Bead filtration excretes.Creatinine is from exogenous and two kinds of endogenous in blood, and exogenous creatinine is meat food generation in vivo Product after thanking;Endogenous creatinine is the product of internal musculature metabolism.When meat food intake is stablized, the flesh of body Meat metabolism and not big variation, the generation of creatinine will be more constant.
It is commonly considered as interior green blood creatinine, interior myogenic acid anhydride is the product of human muscle's metabolism.In muscle, creatine mainly leads to It crosses irreversible non-enzymatic dehydration and gently forms creatinine, then be discharged into blood, with homaluria.Clinically detect serum creatinine It is common one of the main method for understanding renal function.Serum creatinine normal value standard is:(region and hospital are or not 44-133umol/L With numerical value difference, man 53~106umol/L, 44~97umol/L of female).
Urine creatinine essentially from blood, excluded with urine after glomerular filtration it is external, renal tubule do not absorb substantially and Discharge is seldom.It is seldom helpful for evaluation renal function individually to measure concentration of urinary creatinine, but is measured together with serum creatinine, can be used as The required index of endogenous creatinine clearance rate.The normal value of urine creatinine is:7.1~17.7 mmoles of adult male/twenty-four-hour urine, adult 5.3~15.9 mmoles of women/twenty-four-hour urine;That is 40mg/dl to 130mg/dl.Therefore it is generally acknowledged that (being less than 5mg/ without creatinine DL liquid) is not urine.
Creatinine in amniotic fluid is the metabolite of muscular tissue creatine, is drained into through the urine of fetus in amniotic fluid, therefore in amniotic fluid Creatinine value it is related with the maturity of fetal kidney;Content of the creatinine content in early period and blood in amniotic fluid is similar, arrives Latter half of gestation, content are risen, but overall content is significantly lower than urine.Creatinine normal value in clinical amniotic fluid:
Early pregnancy:70.7~97.2 μm of ol/L (0.8~1.1mg/dl)
Full-term pregnancy:159.1~353.6 μm of ol/L (1.8~4.0mg/dl)
Invention content
Technical problem to be solved by the invention is to provide a kind of prematures rupture of fetal membranes to detect protection pad, distinguishes amniotic fluid and urine, carries The accuracy of high premature rupture of fetal membranes monitoring.
The technical solution adopted by the present invention to solve the technical problems is to provide a kind of premature rupture of fetal membranes detection protection pad, including upper Isolation permeable formation, the detection layers of middle layer and the absorbed layer of lower layer of layer, the detection layers contain pH indicators and creatinine inspection Test agent, the pH indicators and creatinine detection reagent are fixed on absorbed layer spaced reciprocally by hydrophilic carrier respectively On, the color range of the pH indicators is pH >=6.5, and the detection threshold value of the creatinine detection reagent is 5~40mg/dl.
The pH indicators and creatinine detection reagent upper layer have been covered each by transparent barrier film.
The color range of the pH indicators is pH6.5~pH7.0.
Spacing distance between the hydrophilic carrier and the hydrophilic carrier of creatinine detection reagent of the pH indicators exists 5mm or more.
The hydrophilic carrier of the pH indicators and the hydrophilic carrier of creatinine detection reagent are in absorbing layer surface side by side It is spaced apart or concentric ring is spaced apart.
The pH indicators are phenol red reagent or bromthymol blue reagent.
The creatinine detection reagent is 3,5- dinitrobenzoic acid reagents, 3,3,5,5- tetramethyl benzidines reagent, creatinine De- imines enzymatic reagent or creatinine amidohydrolase hydrolyze enzymatic reagent.
The isolation permeable formation uses medical micro porouse filter membrane.
It is equipped with leakproof film or release paper containing water suction macromolecule resin, the bottom surface of the absorbed layer in the absorbed layer, The absorbed layer is equipped with fixation adhesive tape.
The protection pad detects underpants with the combined integrated disposable premature rupture of fetal membranes of formation of underpants.
Advantageous effect
First, specificity is high, using pH indicators and the bigeminy reagent of creatinine detection reagent synchronize be detected, effectively Interference of the general urine to detection is excluded, the accuracy detected to amniotic fluid is improved, to reduce the probability of detection false positive;
Second, it is easy to operate, using the form of protection pad or disposable pants, sample sampling is avoided, is referred to without operation Leading can detect and find premature rupture of fetal membranes in time.
Description of the drawings
Fig. 1 is the structural diagram of the present invention.
Specific implementation mode
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention Rather than it limits the scope of the invention.In addition, it should also be understood that, after reading the content taught by the present invention, people in the art Member can make various changes or modifications the present invention, and such equivalent forms equally fall within the application the appended claims and limited Range.
A kind of premature rupture of fetal membranes as shown in Figure 1 detects protection pad, includes the detection layers 2 of the isolation permeable formation 1 on upper layer, middle layer With the absorbed layer 3 of lower layer.
Permeable formation 1, which is isolated, uses medical micro porouse filter membrane, rapid drain that can either avoid the interference of some impurity, simultaneously The stimulation of materials on skin can be reduced.
Detection layers 2 are detected amniotic fluid using bigeminy reagent, and bigeminy reagent is pH indicators and creatinine detection reagent. PH indicators and creatinine detection reagent are fixed on by hydrophilic carrier on absorbed layer 3 spaced reciprocally respectively, and hydrophily carries Body is spaced apart in 3 surface spacing side by side distribution of absorbed layer or concentric ring, and spacing distance between the two is in 5mm or more, parent Aqueous carrier material is using cellulosic filter paper or flexible cotton material.Meanwhile in order to avoid detection reagent is to the possible thorn of skin Swash, pH indicators and creatinine detection reagent upper layer have been covered each by layer of transparent isolation film, also reduce between two kinds of reagents Interactional risk.
Ranging from pH >=6.5 the pH that pH indicator can obviously judge can obviously be developed the color in pH6.5 or more, in pH Variation is not generated when less than 6.5, or has apparent color to distinguish, the color range of pH indicator is most between 6.5~7.0 It is good, including but not limited to phenol red reagent, bromthymol blue reagent etc..
The detection threshold value of creatinine (CRE) detection reagent is 5~40mg/dl, using dry type test paper (chemical method or enzyme process) Detect the content of creatinine in body fluid.Chemical method includes 3,5- dinitrobenzoic acids method or 3,3,5,5- tetramethyl benzidines (TMB) method;Enzyme process includes Creatinine deiminase method or creatinine amidohydrolase hydrolysis enzyme process.When the creatinine content in liquid is more than detection Threshold value, reagent have apparent color change, can effectively distinguish urine and other liquid.
It is equipped with leakproof film or release paper containing water suction macromolecule resin, the bottom surface of absorbed layer 3 in absorbed layer 3, it can be right The liquid of discharge is absorbed rapidly, effectively prevent revealing.Absorbed layer 3 is additionally provided with fixation adhesive tape, facilitates the fixation of protection pad.
Result judgement:When creatinine detection reagent has apparent color change, no matter whether pH indicator develops the color, under judgement Body trickle is urine;Creatinine detection reagent color was substantially unchanged at that time, and pH discolorations are apparent, judge that lower body trickle is Amniotic fluid.Using pH indicators and the bigeminy reagent of creatinine detection reagent synchronize be detected, specificity is high, effectively excludes general Interference of the urine to detection improves the accuracy detected to amniotic fluid, to reduce the probability of detection false positive.

Claims (10)

1. a kind of premature rupture of fetal membranes detects protection pad, including the detection layers (2) of the isolation permeable formation (1) on upper layer, middle layer and lower layer Absorbed layer (3), it is characterised in that:The detection layers (2) contain pH indicators and creatinine detection reagent, the pH indicators It is fixed on spaced reciprocally by hydrophilic carrier on absorbed layer (3) respectively with creatinine detection reagent, the pH indicators Color range is pH >=6.5, and the detection threshold value of the creatinine detection reagent is 5~40mg/dl.
2. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The pH indicators and creatinine Detection reagent upper layer has been covered each by transparent barrier film.
3. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The colour developing of the pH indicators Ranging from pH6.5~pH7.0.
4. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The pH indicators it is hydrophilic Spacing distance between property carrier and the hydrophilic carrier of creatinine detection reagent is in 5mm or more.
5. a kind of premature rupture of fetal membranes according to claim 1 or 4 detects protection pad, it is characterised in that:The pH indicators Hydrophilic carrier and the hydrophilic carrier of creatinine detection reagent are in the distribution of absorbed layer (3) surface spacing side by side or concentric central spacer Distribution.
6. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The pH indicators are phenol red Reagent or bromthymol blue reagent.
7. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The creatinine detection reagent is 3, 5- dinitrobenzoic acid reagents, 3,3,5,5- tetramethyl benzidines reagent, Creatinine deiminase reagent or creatinine amidohydrolase hydrolysis Enzymatic reagent.
8. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The isolation permeable formation (1) is adopted With medical micro porouse filter membrane.
9. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:Contain in the absorbed layer (3) Absorb water macromolecule resin, and the bottom surface of the absorbed layer (3) is equipped with leakproof film or release paper, and the absorbed layer (3), which is equipped with, fixes Adhesive tape.
10. a kind of premature rupture of fetal membranes according to claim 1 detects protection pad, it is characterised in that:The protection pad is unified with underpants group Body forms disposable premature rupture of fetal membranes detection underpants.
CN201810291342.1A 2018-04-03 2018-04-03 Premature rupture of fetal membranes detects protection pad Pending CN108542596A (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030017605A1 (en) * 2001-07-19 2003-01-23 Common Sense Ltd. Diagnostic pad
US20050131287A1 (en) * 2003-12-16 2005-06-16 Kimberly-Clark Worldwide, Inc. Detection of premature rupture of the amniotic membrane
WO2009050711A2 (en) * 2007-10-18 2009-04-23 Jacob Mullerad A diagnostic device for identifying rupture of membrane during pregnancy
CN101813702A (en) * 2010-04-01 2010-08-25 苏州市玮琪生物科技有限公司 Tool and method for diagnosing premature rupture of membrane by continuous monitoring
CN201752403U (en) * 2010-04-01 2011-03-02 苏州市玮琪生物科技有限公司 Diagnostic tool for continuously monitoring premature rupture of membrane
CN204636718U (en) * 2015-05-12 2015-09-16 辛琰琰 Amniotic fluid detects health-care protection pad

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030017605A1 (en) * 2001-07-19 2003-01-23 Common Sense Ltd. Diagnostic pad
US20050131287A1 (en) * 2003-12-16 2005-06-16 Kimberly-Clark Worldwide, Inc. Detection of premature rupture of the amniotic membrane
WO2009050711A2 (en) * 2007-10-18 2009-04-23 Jacob Mullerad A diagnostic device for identifying rupture of membrane during pregnancy
CN101813702A (en) * 2010-04-01 2010-08-25 苏州市玮琪生物科技有限公司 Tool and method for diagnosing premature rupture of membrane by continuous monitoring
CN201752403U (en) * 2010-04-01 2011-03-02 苏州市玮琪生物科技有限公司 Diagnostic tool for continuously monitoring premature rupture of membrane
CN204636718U (en) * 2015-05-12 2015-09-16 辛琰琰 Amniotic fluid detects health-care protection pad

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Application publication date: 20180918