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WO2000049948A2 - Collecteur d'urine - Google Patents

Collecteur d'urine Download PDF

Info

Publication number
WO2000049948A2
WO2000049948A2 PCT/GB2000/000587 GB0000587W WO0049948A2 WO 2000049948 A2 WO2000049948 A2 WO 2000049948A2 GB 0000587 W GB0000587 W GB 0000587W WO 0049948 A2 WO0049948 A2 WO 0049948A2
Authority
WO
WIPO (PCT)
Prior art keywords
patch
urine
test
absorbent material
lactose
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2000/000587
Other languages
English (en)
Other versions
WO2000049948A3 (fr
Inventor
Clive William Mulholland
David Ian Thurnham
Christine Anne Northrop-Clewes
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ulster University
Original Assignee
Ulster University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB9903934.9A external-priority patent/GB9903934D0/en
Priority claimed from GBGB9905234.2A external-priority patent/GB9905234D0/en
Priority claimed from GBGB9913634.3A external-priority patent/GB9913634D0/en
Application filed by Ulster University filed Critical Ulster University
Priority to AU26798/00A priority Critical patent/AU2679800A/en
Publication of WO2000049948A2 publication Critical patent/WO2000049948A2/fr
Publication of WO2000049948A3 publication Critical patent/WO2000049948A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/007—Devices for taking samples of body liquids for taking urine samples

Definitions

  • the present invention relates to a device for the collection of urine specimens.
  • the device is particularly suitable for use with paediatric patients. More particularly the invention relates to a device for collecting urine samples which is not required to be attached to a patient .
  • the invention also relates to a urine based test for vitamin A deficiency in babies.
  • Absorbant pads such as sanitary towels can be used to collect urine. However, such pads are not designed to collect fluid to be tested. Therefore, there is no simple way for uncontaminated urine to be removed from these for testing and chemicals used in the absorbent material may react with the urine.
  • the present invention aims to provide a device for collecting a urine sample which does not require to be stuck to the patient and which can be used to collect samples from neonates, infants and mentally challenged patients for testing.
  • the invention also aims to provide such a device incorporating a test or tests.
  • the invention also aims to provide a urine based test for vitamin A deficiency wherein the test is based on urine sampling.
  • the World Health Organization (WHO) through its Extended Programme of Immunisation (EPI) is planning to include vitamin A supplementation within the immunisation schedule.
  • An appropriate method to measure vitamin A status i.e. cheap and easy to use is needed to monitor the effectiveness of the programme.
  • Vitamin A is necessary for the growth and differentiation of many tissues but particularly the epithelial tissues.
  • the association between vitamin A deficiency and eye disease is well established but there is also evidence that the epithelium of the gut is impaired in marginal deficiency.
  • the present inventors have shown that vitamin A improves recovery of the integrity of epithelial tissues that has been damaged by viruses or other pathogens during infection.
  • the integrity of the gut is closely linked to the - growth and health of the young infants.
  • a test which measures the permeability of two non-metabolised sugars through the gut wall, is used to measure gut integrity.
  • Analysis of data collected in The Gambia showed that gut integrity in infants was at its best in those months of the year when vitamin A intake was at its highest.
  • the inventors carried out studies in Indian infants which showed that gut integrity improved in direct response to vitamin A supplementation.
  • villi Associated with the impairment in gut integrity is an alteration in the morphology of the gut.
  • the normal surface of the gut is highly convoluted and the surface is covered with finger-like projections known as villi .
  • These villi become flattened in association with impaired gut integrity.
  • the 'flattening' may occur as a result of a loss of the equilibrium between cell production in the epithelial layer and the 'sloughing off of old cells from the tips of the villi.
  • Lactase is the enzyme necessary for the digestion of lactose. Lactase is found in those cells near the tip of the villi and the lactase enzyme activity appears to fall as flattening of the gut occurs and there is a loss of gut integrity.
  • a urine sampling patch comprising an absorbent material to collect urine, a membrane which covers the top surface of the absorbent material which allows the urine to pass through to the absorbent material, and a waterproof backing which covers the bottom surface of the absorbent material .
  • the patch has a degree of flexibility to allow for shaping in a support.
  • the support will comprise a nappy or pants.
  • an adhesive strip on the back of the patch enables it to be stuck to the support.
  • the absorbent material is inert.
  • the absorbent material should preferably not react chemically with urine and should be typically between 3-20mm, more preferably 5-10mm thick.
  • the covering membrane allows urine to pass through to the absorbent material beneath and prevents urine being kept on the skin.
  • Different shapes of patches may be available for male and female infants to allow for variable positioning in a support. Also, different sizes of patches may be preferred for use with neonates, toddlers and older patients.
  • the absorbent material is as absorbent as possible and as thin as possible to improve flexibility of the patch.
  • the patch may further comprise an aperture in the membrane of the top surface or in the waterproof backing that can be opened, for example by peeling back a strip, to allow urine to be extracted for analysis by traditional means, or to enable a 'normal' dipstick to be inserted into the patch.
  • the patch can be squeezed or rolled up to extract urine from the patch.
  • a lemon squeezer type gadget may be used.
  • the invention may further comprise or be attachable to a connector or nipple to allow urine to be squeezed directly into a sample tube which maybe plain, or contain a fixed quantity of preservative to stabilise the urine specimen.
  • a connector or nipple to allow urine to be squeezed directly into a sample tube which maybe plain, or contain a fixed quantity of preservative to stabilise the urine specimen.
  • An option is to incorporate reagent test areas for specific analytes into the patch along with a suitable reading frame .
  • the reagent areas may be physically separated from urine until after the patch is removed from the nappy. This could be achieved, for example, by enclosing the test area in a 'bubble' using a similar material and approach to 'bubblewrap' packaging.
  • the reactions in the test area are initiated by gently squeezing the bubble until it bursts, thus allowing the reagent area to come into contact with urine in the patch.
  • This embodiment is useful if it is important to know the timing of the test.
  • the covering membrane only allows urine to pass one way into the patch.
  • the material on each side of the membrane could be of differing sizes. This would create a diffusion concentration gradient that would 'draw' the urine into the patch.
  • the membrane also be preferably transparent or contain a transparent window to allow reading of any reagent test areas that may be incorporated into the patch.
  • a variety of sizes and shapes of the patch are envisaged.
  • a variety of materials may be used as waterproof backing. Suitable materials include thin plastic film, woven and nonwoven materials, polymeric films or composite materials. These and other materials may be coated to provide a waterproof finish. Suitably the material may be waterproof but breathable to allow vapour to escape .
  • absorbent materials can be employed to collect urine.
  • Suitable absorbent materials are capable of absorbing any retaining liquid and may comprise or be based on any of the following materials - absorbent sponges, tissue, wood pulp, cellulose or any other known absorbent material or combination of materials.
  • Different covering membranes may be used to allow one way passage of urine.
  • Suitable membrane materials may be chosen from the group comprising plastic films, woven or nonwoven fibres, polyester or polypropylene fibres of any suitable combination of natural and/or synthetic fibres which allow passage of fluid or which are made porous or have apertures to allow passage of fluid.
  • a variety of mechanisms to employ collected urine from the patch for testing may be used.
  • test areas may be suitable to alter the make up of reagent test areas to end point reactions to provide a stable coloured product. By doing this the test areas do not need to be separated from the urine. Reactions can take place in the patch as soon as urine has been voided and comes into contact with the reaction areas.
  • the patch comprises a strip test such as BM-Test ® strips for urinalysis. These strips can be closed from the urine until required by having a closure strip enclose the test and protect the chemistries by keeping it separate from the urine. The strips may be opened by having strings attached which can extend from the patch and which can be pulled away or pealed back to remove the closure strip.
  • a strip test such as BM-Test ® strips for urinalysis.
  • This embodiment is particularly useful for timed tests.
  • An alternative embodiment comprises a reactant held in a bubble in the patch.
  • the bubble can be physically burst to allow the reactant to come into contact with the urine. This embodiment is also useful for tests which are timed.
  • the present invention may be used for routine diagnostic and monitoring purposes (e.g. pH, glucose, blood, protein, specific gravity) in neonatal and paediatric units.
  • routine diagnostic and monitoring purposes e.g. pH, glucose, blood, protein, specific gravity
  • Screening tests for drugs of abuse may be incorporated in the patch.
  • Screening tests for urinary tract infections and meningitis may be incorporated in the patch.
  • a patch testing for urinary bilirubin could be used for screening for biliary atresia.
  • test for vitamin A deficiency comprising means for detecting lactose in urine.
  • lactose also known as milk sugar
  • lactose is the main carbohydrate in milk-based infant foods
  • lactose is the main source of carbohydrate for infants.
  • the present inventors have found that the presence of lactose in the urine of infants is an indicator of poor vitamin A status.
  • Lactose is a disaccharide made up from two simple sugars, glucose and galactose. Glucose has 'reducing properties' and can be measured in urine by tests which have already been established to measure glucose in the urine of diabetic patients. Lactose also has reducing properties and it may also be possible to use the same dipsticks to measure the presence of lactose in urine.
  • the invention provides a dipstick for measuring or detecting the presence of lactose in solution.
  • the dipstick detects the presence of lactose in urine .
  • the invention also provides the use of a dipstick for the detection of glucose for the detection of lactose in order to assess vitamin A deficiency in infants.
  • the invention provides a strip which changes colour in the presence of lactose.
  • the strip is presented in a patch as described in the first aspect of the invention which can be incorporated into a disposable diaper.
  • the invention also provides an absorbent strip incorporatable in a patch for the detection of a substance in urine.
  • an absorbent strip in a patch in a diaper could be used to test for one or more of a variety of substances. This has the advantage of not requiring samples of urine to be taken as this is difficult with infants. Also, such strips could be routinely incorporated in patches in diapers to alert a mother or carer to the possibility of infection or unusual metabolism.
  • a diagnostic patch is incorporated within a nappy.
  • a "stick-on" patch can be applied to nappies.
  • the diagnostic patches could be used for a number of possible conditions: In new-boms the strip could be used routinely to test for blood, protein and sugar.
  • Older babies could be screened for blood, protein sugar or ketones using the "stick-on diagnostic strip".
  • the strip will screen for biliary atresia by measuring urobilinogen/ bilirubin.
  • Urinary tract infections in infancy are often under-diagnosed and so a diagnostic strip in the nappy to measure nitrite and the enzyme, leucocyte esterase could be a useful screening tool.
  • the diagnostic nappy could also be used to identify babies with Coeliac disease or cow's milk protein intolerance.
  • the nappy may be used as a diagnostic tool for the detection of lactose in vitamin A deficient infants.
  • the chemistry already exists to detect all the above chemicals in urine, but the tests would need modification to allow their use in the nappy diagnostic method.
  • a diagnostic nappy as a screening method would be useful in the hospital situation, including premature baby units, but also some might be available over the counter to allow a "worried mother" to screen their babies before visiting their GP.
  • FIG. 1 diagrammatically illustrates a patch according to the invention.
  • Figure 2 illustrates a patch incorporating a strip test.
  • the patch comprises an upper membrane (1) , an absorbent core (2) and a waterproof backing (3) .
  • An adhesive strip (4) enables the patch to be attached to a support.
  • test strip (5) including reagent areas (6) is incorporated in a patch.
  • the reagent areas can be kept covered until the patch is removed for testing. Pulling on the strings (7) peals back the upper closure strip (8) of the test and allows the reaction areas to react with the urine.
  • Measurements may be influenced by other solutions being tested in study. However there is still clear difference in metabolism of lactose when infants are Vitamin A deficient.
  • the English controls are similar to the Irish controls in Example 1.
  • the Pakistani samples have results slightly higher than the Indian ones but the Gambian samples are three times higher than the Indian ones.
  • the results show a trend between Vitamin A deficiency and lactose in urine in infants.
  • a lactose dip stick test would provide a simple test of Vitamin A deficiency.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un bandeau collecteur d'urine destiné à collecter des échantillons d'urine, notamment dans le cas des patients incapables de fournir des échantillons à écoulement libre. Le dispositif peut incorporer des réactifs de test, de manière à ce que l'on puisse effectuer des tests in situ. Les réactifs peuvent être séparés de l'urine pour permettre des tests à retardement. L'invention concerne aussi un test de lactose à base d'urine servant d'indicateur d'une perturbation de l'intégrité des intestins.
PCT/GB2000/000587 1999-02-22 2000-02-21 Collecteur d'urine Ceased WO2000049948A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU26798/00A AU2679800A (en) 1999-02-22 2000-02-21 Urine collector

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GBGB9903934.9A GB9903934D0 (en) 1999-02-22 1999-02-22 Method
GB9903934.9 1999-02-22
GB9905234.2 1999-03-09
GBGB9905234.2A GB9905234D0 (en) 1999-03-09 1999-03-09 Method
GB9913634.3 1999-06-12
GBGB9913634.3A GB9913634D0 (en) 1999-06-12 1999-06-12 Collector

Publications (2)

Publication Number Publication Date
WO2000049948A2 true WO2000049948A2 (fr) 2000-08-31
WO2000049948A3 WO2000049948A3 (fr) 2000-12-07

Family

ID=27269654

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2000/000587 Ceased WO2000049948A2 (fr) 1999-02-22 2000-02-21 Collecteur d'urine

Country Status (2)

Country Link
AU (1) AU2679800A (fr)
WO (1) WO2000049948A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082485A1 (fr) * 2003-03-18 2004-09-30 Willett International Limited Dispositif permettant de detecter ou de surveiller de maniere non invasive une pathologie medicale chez un mammifere
US8043272B2 (en) 2007-04-30 2011-10-25 Kimberly-Clark Worldwide, Inc. Collection and testing of infant urine using an absorbent article
WO2013147661A1 (fr) * 2012-03-30 2013-10-03 Sca Hygiene Products Ab Dispositif de collecte d'urine
JP2015516803A (ja) * 2012-03-30 2015-06-18 エスセーアー・ハイジーン・プロダクツ・アーベー 流体採取デバイス及び採取のための方法
WO2016207799A1 (fr) * 2015-06-22 2016-12-29 Koninklijke Philips N.V. Appareil de photothérapie avec collecteur d'urine intégrée et capteur permettant la réduction des effets secondaires

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2987174A (en) * 1960-05-06 1961-06-06 Miles Lab Test sample container
US4605404A (en) * 1985-01-16 1986-08-12 Sneider Vincent R Disposable pad for panty hose
CA2051787A1 (fr) * 1991-09-18 1993-03-19 Jonathan B. Meddings Methode de detection des dommages a l'ephithelium gastrique
FR2682591A1 (fr) * 1991-10-16 1993-04-23 Proteco Sarl Couche-culotte a haut pouvoir absorbant.
US5383885A (en) * 1993-06-29 1995-01-24 Bland; Todd A. Blood collection and testing device
US5815260A (en) * 1995-10-18 1998-09-29 Kyoto Dai-Ichi Kagaku Co., Ltd. Urogenous component measuring apparatus for qualitatively/quantitatively measuring a plurality of urogenous components
US5876389A (en) * 1996-06-24 1999-03-02 Ezy-Detek (Edi) Inc. Sanitary napkins and method for collecting samples of bodily substances
AU2648097A (en) * 1997-05-13 1998-12-08 Nicola Pedrozzi Urine collector for pediatric practice
US5922614A (en) * 1997-06-04 1999-07-13 Avitar Incorporated Sample collection method with extraction sleeve

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
None

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004082485A1 (fr) * 2003-03-18 2004-09-30 Willett International Limited Dispositif permettant de detecter ou de surveiller de maniere non invasive une pathologie medicale chez un mammifere
US8043272B2 (en) 2007-04-30 2011-10-25 Kimberly-Clark Worldwide, Inc. Collection and testing of infant urine using an absorbent article
WO2013147661A1 (fr) * 2012-03-30 2013-10-03 Sca Hygiene Products Ab Dispositif de collecte d'urine
JP2015516803A (ja) * 2012-03-30 2015-06-18 エスセーアー・ハイジーン・プロダクツ・アーベー 流体採取デバイス及び採取のための方法
AU2012375452B2 (en) * 2012-03-30 2016-03-17 Sca Hygiene Products Ab Fluid sampling device and method for sampling
US9510808B2 (en) 2012-03-30 2016-12-06 Sca Hygiene Products Ab Fluid sampling device and method for sampling
WO2016207799A1 (fr) * 2015-06-22 2016-12-29 Koninklijke Philips N.V. Appareil de photothérapie avec collecteur d'urine intégrée et capteur permettant la réduction des effets secondaires

Also Published As

Publication number Publication date
AU2679800A (en) 2000-09-14
WO2000049948A3 (fr) 2000-12-07

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