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WO2005107602A1 - Dispositif collecteur d'urine - Google Patents

Dispositif collecteur d'urine Download PDF

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Publication number
WO2005107602A1
WO2005107602A1 PCT/GB2005/001755 GB2005001755W WO2005107602A1 WO 2005107602 A1 WO2005107602 A1 WO 2005107602A1 GB 2005001755 W GB2005001755 W GB 2005001755W WO 2005107602 A1 WO2005107602 A1 WO 2005107602A1
Authority
WO
WIPO (PCT)
Prior art keywords
urine
hood
outlet
accordance
collection device
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/GB2005/001755
Other languages
English (en)
Inventor
Robert William Cunningham
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.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Priority to EP05746396A priority Critical patent/EP1750588A1/fr
Publication of WO2005107602A1 publication Critical patent/WO2005107602A1/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

  • STD sexually transmitted diseases
  • chlamydia ⁇ Chlamydia trachomatis Chlamydia trachomatis
  • gonorrhoea Neisseria gonorrhoea
  • Over 100 million new cases of chlamydia and . 70 million cases of gonorrhoea are reported each year.
  • a method has been described utilising magnetic particles coated with antibodies to either Chlamydia trachomatis or Neisseria gonorrhoea prior to use in a rapid test.
  • a urine sample is added to the magnetic particle suspension and incubated for 15 minutes with occasional mixing.
  • the test tube is then put into a magnetic rack and the particles quickly stick to the side of the tube.
  • the urine is decanted.
  • the tube is taken off the rack and buffer wash solution added.
  • the tube is then put back on to the rack and the wash solution decanted.
  • a chemical is added to cleave the captured bacteria from the magnetic particles and a sample removed for testing. Whilst the above tests are capable of being used, there are one or two fundamental problems associated with them.
  • a far less invasive method would be to collect a urine sample.
  • men since chlamydia and gonorrhoea organisms infect the urethra, they are voided in significant quantities during urination.
  • women the urethra is remote from the vagina, where the STD organisms are usually harboured. A small number of organisms are washed away from the vaginal area during urination but such a sample would contain significantly less organisms than would a male sample. It can be seen that in order for a urine test to be used in females, whatever test technology might be employed on the urine sample, to work to optimum sensitivity, it would be important to collect as many bacterial cells as possible prior to testing.
  • the clitoris is a small structure seen at the top of the labia minora.
  • the urethra lies between the vaginal entrance and the clitoris.
  • the vestibule is an area of smooth skin which contains the orifice of the urethra and the entrance to the vagina.
  • the first 10-20 ml of urine passing over the area of the vestibule will contain the highest number of bacterial cells. It further follows that if urine can be specifically directed over that area of the vestibule, in order to wash vaginal fluid containing bacterial cells, rather than relying on opportunistic sampling, then an optimal number of bacterial cells can be collected during the first pass of the first morning urine.
  • US published patent application 2003/0149408 describes a urine collection apparatus for the collection of a sample of urine from a female user for testing.
  • a device is described having a hood portion seating over the pubic area, and an elongate channel portion extending away therefrom, and providing an aperture to which a collection bottle can be coupled, and a second aperture to void urine.
  • a urine collection device comprising a funnel having a relatively large concave hood portion serving as a receptor for urine in fluid communication with a relatively narrow elongate channel portion extending generally away from the receptor hood portion and providing a urine void outlet at a distal end, wherein the receptor hood portion has a perimeter so shaped as to locate in use in the pubic area over at least the area of the labia minora and the urethral and vaginal openings and more preferably over substantially the entire vulva, from the mons pubis to the perineum and the perimeter of the labia majoris, and is provided with a partial closure extending generally across an upper part of said hood so as to extend beyond the urethral opening and at least part of the way towards the vestibule of the vagina in use, and wherein the channel portion is further provided with a urine collection outlet comprising an aperture in the side of the channel wall so placed as to be directed generally downwardly in use with the said perimeter so located
  • the receptor hood is located in the pubic area of the female user so that the perimeter engages against the pubic area, and in particular forms a substantially leak proof contact around at least the labia minora and the urethral and vaginal openings.
  • the receptor hood has a generally concave structure, with the hood surface bounded by the said perimeter defining a urine collection area.
  • a junction aperture in the hood surface away from the perimeter effects a fluid communication junction with a channel portion extending generally away therefrom.
  • An upper part of the opening of the hood is closed by the partial closure, which in use seats against the corresponding upper part of the pubic area to cover the urethal opening, but is shaped so as to define, in co-operation with the user's body, a flow channel directing urine therefrom towards and over the vestibule area before it is able to pass through the part of the hood opening where the closure is not present and into the urine collection area defined by the hood.
  • the closure extends from the top of the hood opening perimeter, and preferably over at least half of the area of the hood defined by the hood perimeter.
  • the junction aperture is preferably provided generally opposite the open area of the hood, that is in the lower portion of the hood in use, to allow urine flow to pass into the channel portion.
  • the channel portion has an open distal end in conventional funnel-like manner and also a second aperture comprising an opening in the channel wall, so located as to lie generally at the lower wall of the channel in use, through which a sample for collection will pass.
  • This aperture is a particular adaptation to collect the initial part of a urination, and in a preferred mode of use is linked to a sample container of suitably restricted size to collect the desired sample.
  • the third principle in the design of the device in accordance with the invention is that it will neatly and cleanly collect the first 10-30 ml of the first pass of urine, for example the first morning urine via the collection outlet, for example into an attached urine collection tube, and subsequently allow the remaining passed urine to flow away from the urethra into the toilet bowl.
  • this initial sample especially in the morning, will contain a higher concentrated sample of bacterial cells from a sexually transmitted disease.
  • the collection outlet comprises an aperture or apertures in the channel wall along the length thereof facing generally downwardly in use and of such size and structure that at least a sufficient part of the initial flow of urine voided from the body at normal speeds and pressures and flowing along the channel portion will be diverted preferentially via this outlet.
  • the sample so diverted is then passed via the collection outlet to a suitable sample collection container, adapted to be in fluid communication therewith, and in a preferred embodiment the invention comprises a device wherein a suitable substantially leak proof connection is provided for the attachment of such a sample container, and in particular for the leak-proof attachments of a succession of such sample containers to facilitate repeated use of the device.
  • the invention in a further aspect comprises a urine collection apparatus with such a suitable sample container attached and/ or provided in kit form with one or more such suitable sample containers adapted to be attachable thereto.
  • the hood portion forms the open, urine collection part of the funnel-like structure of the device of the present invention. It is adapted to sit in intimate contact with a user, with the perimeter thereof engaging the user's body, preferably in substantially leak proof manner.
  • the hood portion is preferably fabricated to exhibit a degree of flexible resilience, for example being fabricated from flexibly resilient material, at least at the perimeter where engagement is made with the body surface, to conform to a range of individual body shapes.
  • the hood portion will typically exhibit lateral symmetry corresponding to the lateral symmetry of the human body, being mirror symmetrical about a longitudinal axis corresponding in use to the longitudinal axis of the user's body.
  • the perimeter of the hood portion will then typically thus comprise a pubic contacting and locating portion at a first end of this axis adapted to contact with and locate the device on an anterior surface of the pubic region in use, a perineal contacting and locating portion at the other end of the longitudinal axis adapted to contact and locate the device at the perineum, and labial contacting portions extending therebetween and adapted to make contact with, and for example enclose, the area of the labia majora.
  • the collection outlet aperture is laterally spaced along the channel portion away from its junction with the hood portion and from the communicating aperture between the hood portion surface and the channel portion. This spacing can help to ensure that the flow of urine along the channel portion has reached a steady, relatively non-turbulent state and has slowed sufficiently to ensure that at least a sufficient part of the flow is diverted via the collection outlet.
  • the collection outlet is preferably spaced along the channel portion away from its junction with the hood portion by at least 15 mm, more preferably by at least 25 mm.
  • the preferred design of the junction will be such as to achieve two specific functions. Firstly, the raised flow barrier will divert more of the initial urine flow from the urethra into the collection tube. Secondly, the septum portion will allow the flow of air expelled from an attached collection tube through the channel defined thereby on the distal side. Thus the initial urine flow will not be impeded. However, when the collection tube becomes full, further urine will still be able to flow to the void outlet.
  • the hood portion and the channel portion may comprise an integrally formed whole, which will generally facilitate fabrication, for example via a single mould.
  • the hood portion and the channel portion may comprise separately formed structures mechanically connected together by a screw threaded, bayonet, interference fit or other mechanical connection.
  • Each portion may itself comprise a modular structure.
  • Each portion may itself comprise a modular structure.
  • Modular structures may offer greater flexibility in relation to sterilisation of used equipment, and may in particular allow that the invention comprises one or more modules which are sterilisable for reuse to be used in conjunction with one or more modules which are disposable.
  • any urine collection channel means and/ or sample container provided as part of or for use with or used with the collection device will conveniently incorporate means to impede reverse flow, and in particular means tending to close the flow channel defined via the collection outlet to the sample container as the sample container becomes full.
  • a sample container incorporates an opening of reduced dimension, for example being a tube with a neck of reduced diameter, and includes a float valve which acts to close the opening once the sample container contains sufficient sample.
  • a collection tube incorporates a circular plastic disc float at the time of application of the device to the vulva, designed to be of a diameter slightly smaller than that of the collection tube, so that as the urine flows into the collection tube it will float to the surface of the tube until it reaches the neck serving as the point of the ingress of the urine into the collection tube. This will effectively prevent any further urine entering the collection tube. Thus further urine will simply continue along the main conduit to the void outlet and into the toilet bowl, and will not contaminate the first flow sample that has been collected.
  • the device After the completion of the micturition cycle, the device will be removed from the vulva and the sample container disconnected from the urine collection device.
  • the urine collection device or components thereof may be sterilised for reuse or disposed of as appropriate.
  • a closure can then be applied onto the sample container to retain the integrity of the collected sample.
  • this makes use of the same connection means, for example screw threading, bayonet, or push fit, as was used to attach the sample container to the urine collection device during use.
  • the collected sample can then be preserved for testing for the presence of bacteria concerned with STD by a variety of approved methods.
  • the sample container may contain an amount of magnetic particles coated with antibodies to one or more causative agents of sexually transmitted disease.
  • the Figures illustrate an example of a funnel-like urine collection device in accordance with the principles of the invention.
  • the device consists of a generally conical hood portion 1 and an elongate tubular channel portion 2 fabricated as a single piece moulding from sterilisable plastics material. It will be appreciated that other materials could be used, and that the device could be of modular construction, but the illustrated embodiment is particularly convenient for fabrication as a single moulding.
  • the hood portion 1 has generally conical surface walls 3 which serve to define a urine collection area 4.
  • the hood is defined by perimeters walls which are adapted to be conformable to the shape of the user's body to engage thereon in a generally leak proof contact, and which consist of an upper part 6a adapted to locate upon and engage against the anterior pubic region; a lower part 6b adapted to locate upon and engage against the perineum; and side parts 6c adapted to locate upon the labia majora.
  • a major part of the hood entrance defined by the perimeter 6 is closed by the closure 8 which is so positioned as to extend in use over the urethral opening towards the vagina.
  • the closure is shaped to effect a solid barrier against this area, but is provided with equilateral extrusions 9 which will seat within the labia majora. This will co-operate with the user's body to define a channel which forces urine flow down the labia majora to the vestibule area, and towards the open access to the receptacle portion 4. Urine flow is via a junction aperture 11 into the channel means 2.
  • the channel means is provided with two egress points.
  • the first, spaced laterally along the channel means 2 comprises a collection aperture 12 and downward tubular extension 13.
  • the second comprises a downward tubular extension 14 at a distal end of the channel means to a void aperture 15.
  • urine flows via the aperture 11 into the channel means 2.
  • Initial flow is then diverted via the collection aperture 12 into the collection channel defined by the tube 13 by means of the upward extension 17a of a septum positioned laterally across the diameter of the aperture 12.
  • a downward extension of the septum 17b divides the channel within the tube 13 into two flow portions. Urine is directed essentially into the flow portion proximal to the hood, and reverse air flow is permitted through the flow portion distal to the hood.
  • the device in accordance with the invention thus allows collection of urine in a convenient and hygienic manner reducing the likelihood that stray urine will contaminate the user during collection, and likewise reducing the likelihood that collected urine would be contaminated by a user.
  • the device By forcing urine over the vestibule area before it is transferred to the collection system, the device ensures that as much bacterial contamination as possible is picked up in the sample.
  • the device is specifically adapted to collect preferentially urine from the first flow, which again, particularly if used for the first urination of the day, will assist in concentrating target bacteria within the urine.
  • the device is admirably suited to the collection of a urine sample from a female which has sufficient bacterial concentration to allow the sample to be tested effectively for the presence of a target STD infection and which avoids the need to employ more intrusive techniques which collects samples direct from the vagina.

Landscapes

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

Abstract

L'invention concerne un dispositif collecteur d'urine comportant un entonnoir présentant une partie supérieure concave relativement large, servant de réceptacle pour l'urine, se trouvant en communication fluidique avec une partie canal allongée, relativement étroite, s'éloignant de la partie supérieure réceptrice, présentant une sortie de récipient à urine sur une extrémité distale. La circonférence de la partie supérieure réceptrice est choisie de telle manière que ladite partie supérieure vienne se loger sur la région pubienne, au moins au-dessus de la zone de la lèvre inférieure et des ouvertures urétrales et vaginales, et de préférence au-dessus de l'ensemble de la vulve, du mont de Vénus jusqu'au périnée et la périphérie de la lèvre supérieure. Ledit dispositif collecteur d'urine est également pourvu d'une fermeture partielle s'étendant essentiellement au travers du haut de la partie supérieure de manière à s'étendre au-delà de l'ouverture urétrale et au moins partiellement en direction du vestibule vaginal.
PCT/GB2005/001755 2004-05-07 2005-05-09 Dispositif collecteur d'urine Ceased WO2005107602A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05746396A EP1750588A1 (fr) 2004-05-07 2005-05-09 Dispositif collecteur d'urine

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0410142.4 2004-05-07
GB0410142A GB0410142D0 (en) 2004-05-07 2004-05-07 Urine collection device

Publications (1)

Publication Number Publication Date
WO2005107602A1 true WO2005107602A1 (fr) 2005-11-17

Family

ID=32482797

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2005/001755 Ceased WO2005107602A1 (fr) 2004-05-07 2005-05-09 Dispositif collecteur d'urine

Country Status (3)

Country Link
EP (1) EP1750588A1 (fr)
GB (1) GB0410142D0 (fr)
WO (1) WO2005107602A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010058210A1 (fr) * 2008-11-18 2010-05-27 Knight Scientific Limited Dispositif de collecte d'urine de début de miction
CN102670263A (zh) * 2011-03-16 2012-09-19 杨国煌 导尿装置
WO2014037152A1 (fr) * 2012-09-10 2014-03-13 Universiteit Antwerpen Échantillonneur de liquide, kit de composants, et procédé d'assemblage
WO2014135856A1 (fr) 2013-03-04 2014-09-12 Forte Medical Limited Dispositif de collecte d'urine
GB2520970A (en) * 2013-12-05 2015-06-10 P1 Technology Ltd Collecting a urine sample
CN106669869A (zh) * 2015-11-09 2017-05-17 无锡市凯顺医疗器械制造有限公司 一种密闭体液留置器用取液件
WO2017080421A1 (fr) * 2015-11-09 2017-05-18 单希杰 Fluide participant pour dispositif à demeure de fluide corporel fermé
US20200323519A1 (en) * 2013-12-05 2020-10-15 George Ealovega Urine-specimen collection, storage, and testing device
WO2021097310A1 (fr) 2019-11-13 2021-05-20 The Uab Research Foundation Système de collecte d'urine
CN114916963A (zh) * 2022-06-27 2022-08-19 江西卓瑞华医疗器械有限公司 一种三叉分流型形变拨落式泌尿科用尿检取尿设备
JP2022551904A (ja) * 2019-10-07 2022-12-14 ノヴォサニス エヌブイ 小容積液体サンプラー

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3161891A (en) * 1963-12-12 1964-12-22 Ralph M Bauman Portable urine specimen collecting device
US3750648A (en) * 1971-01-22 1973-08-07 D Gleason Means for collecting specimens of urine
US4106490A (en) * 1976-09-27 1978-08-15 Raymond Spilman Urine collection aid
US4692160A (en) * 1984-05-15 1987-09-08 Max Nussbaumer Urine collector for incontinent women having zig-zag walls
WO1990013280A1 (fr) * 1989-04-28 1990-11-15 Uroshield Pty. Limited Urinal de prise du flux central
US20030149408A1 (en) * 2000-03-30 2003-08-07 Orde Levinson Urination apparatus
WO2003070131A1 (fr) * 2002-02-20 2003-08-28 Orde Levinson Dispositif de collection d'un echantillon d'urine

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3161891A (en) * 1963-12-12 1964-12-22 Ralph M Bauman Portable urine specimen collecting device
US3750648A (en) * 1971-01-22 1973-08-07 D Gleason Means for collecting specimens of urine
US4106490A (en) * 1976-09-27 1978-08-15 Raymond Spilman Urine collection aid
US4692160A (en) * 1984-05-15 1987-09-08 Max Nussbaumer Urine collector for incontinent women having zig-zag walls
WO1990013280A1 (fr) * 1989-04-28 1990-11-15 Uroshield Pty. Limited Urinal de prise du flux central
US20030149408A1 (en) * 2000-03-30 2003-08-07 Orde Levinson Urination apparatus
WO2003070131A1 (fr) * 2002-02-20 2003-08-28 Orde Levinson Dispositif de collection d'un echantillon d'urine

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010058210A1 (fr) * 2008-11-18 2010-05-27 Knight Scientific Limited Dispositif de collecte d'urine de début de miction
CN102670263A (zh) * 2011-03-16 2012-09-19 杨国煌 导尿装置
US9968336B2 (en) 2012-09-10 2018-05-15 Novosanis Nv Liquid sampler, kit of parts, and method for assembly
WO2014037152A1 (fr) * 2012-09-10 2014-03-13 Universiteit Antwerpen Échantillonneur de liquide, kit de composants, et procédé d'assemblage
WO2014135856A1 (fr) 2013-03-04 2014-09-12 Forte Medical Limited Dispositif de collecte d'urine
US11197659B2 (en) 2013-03-04 2021-12-14 Forte Medical Limited Urine collection device
JP2016514261A (ja) * 2013-03-04 2016-05-19 フォルテ・メディカル・リミテッド 採尿装置
EP3701879A1 (fr) 2013-03-04 2020-09-02 Forte Medical Limited Dispositif de collecte d'urine
GB2520970B (en) * 2013-12-05 2015-11-11 P1 Technology Ltd Collecting a urine sample
US9730678B2 (en) 2013-12-05 2017-08-15 P1 Technology Ltd. Collecting a urine sample
US20200323519A1 (en) * 2013-12-05 2020-10-15 George Ealovega Urine-specimen collection, storage, and testing device
GB2520970A (en) * 2013-12-05 2015-06-10 P1 Technology Ltd Collecting a urine sample
US11957321B2 (en) * 2013-12-05 2024-04-16 GLR Medical Innovations, LLC Urine-specimen collection, storage, and testing device
WO2017080421A1 (fr) * 2015-11-09 2017-05-18 单希杰 Fluide participant pour dispositif à demeure de fluide corporel fermé
CN106669869A (zh) * 2015-11-09 2017-05-17 无锡市凯顺医疗器械制造有限公司 一种密闭体液留置器用取液件
JP2022551904A (ja) * 2019-10-07 2022-12-14 ノヴォサニス エヌブイ 小容積液体サンプラー
JP7669351B2 (ja) 2019-10-07 2025-04-28 ノヴォサニス エヌブイ 小容積液体サンプラー
WO2021097310A1 (fr) 2019-11-13 2021-05-20 The Uab Research Foundation Système de collecte d'urine
EP4057955A4 (fr) * 2019-11-13 2023-10-11 The UAB Research Foundation Système de collecte d'urine
US12402865B2 (en) 2019-11-13 2025-09-02 The Uab Research Foundation Urine collection system
CN114916963A (zh) * 2022-06-27 2022-08-19 江西卓瑞华医疗器械有限公司 一种三叉分流型形变拨落式泌尿科用尿检取尿设备

Also Published As

Publication number Publication date
GB0410142D0 (en) 2004-06-09
EP1750588A1 (fr) 2007-02-14

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