WO2005107602A1

WO2005107602A1 - Urine collection device

Info

Publication number: WO2005107602A1
Application number: PCT/GB2005/001755
Authority: WO
Inventors: Robert William Cunningham
Original assignee: Robert William Cunningham
Priority date: 2004-05-07
Filing date: 2005-05-09
Publication date: 2005-11-17
Also published as: EP1750588A1; GB0410142D0

Abstract

A urine collection device is described comprising a funnel having a relatively larger concave hood portion serving as a receptor for urine in fluid communication with a relatively narrower 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 end 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.

Description

URINE COLLECTION DEVICE

The invention relates to a novel device to facilitate collection of urine from women to improve diagnostic efficiency in screening tests for sexually transmitted diseases.

Sexually transmitted diseases (STD) are among the most common causes of illness in the world and have far reaching health, social and economic consequences. In addition to their sheer magnitude, STDs are a major public health problem for two additional reasons: their serious outcomes, and the fact that they facilitate transmission of HIV.

Young adults between 16 and 24 years of age often have high rates of STD and present a particularly important problem because of their lack of easy access to STD services and condoms, and their frequent and multiple casual sex partners.

The two most common sexually transmitted diseases are chlamydia {Chlamydia trachomatis) and gonorrhoea (Neisseria gonorrhoea). Over 100 million new cases of chlamydia and . 70 million cases of gonorrhoea are reported each year.

Gonorrhoea is a common adult disease, although a significant proportion of those with infection are asymptomatic (up to 80% among women, 10% among men). That is to say, they do not have symptoms and therefore they are neither aware of the need for treatment nor of the risk of transmitting the disease to others. Infected men usually have symptoms and seek treatment spontaneously. Co-infection with chlamydia is very common and treatment with antibiotics is simple and highly effective. Chlamydial infection is also a common adult disease. Chlamydia has asymptomatic rates in women similar to those for gonorrhoea, but higher rates of asymptomatic infection than gonorrhoea in men. Like gonorrhoea, chlamydia has serious outcomes such as pelvic inflammatory disease and infertility.

Typically, diagnosis is carried out in a laboratory, using several different techniques. These include microscopic examination, immunoassay using Enzyme Linked Immunosorbent assay (ELISA), and more recently nucleic acid amplification technology (Polymerase Chain Reaction [PCR], or Ligand Chain Reaction [LCR]). Such nucleic acid amplification technology has the benefit of extreme sensitivity, but is relatively expensive, time-consuming and requires skilled technical operators.

There has been a pressing need to have a rapid test that can be carried out quickly and easily, giving results within a very short period of time. Some tests have been developed using a lateral flow device, along the lines of a pregnancy test.

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.

Firstly, males are infected in the urethra, the tube leading out from the bladder, and females in the vagina. The best sample is obtained using swabs. In women, skill is needed to take an adequate sample, and many women consider the act as invasive and uncomfortable. In men, the taking of a urethral swab sample can be extremely painful, and many men will simply avoid having such a sample taken.

A far less invasive method would be to collect a urine sample. In men, since chlamydia and gonorrhoea organisms infect the urethra, they are voided in significant quantities during urination. However, in 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 term "vulva" is used to describe the outer female genitalia. It extends from the mons pubis to the perineum, and contains the labia majora, labia minora, clitoris, urethra and vagina. The mons pubis is the mound-like fatty tissue that covers the pubic bone and itself is covered by skin and hair. The perineum is the area between the vaginal area and the anus. The labia majora are the two larger folds that are covered with pubic hair and fold over the rest of the vulva. They contain fatty tissue and help keep the vaginal entrance closed, which assists in the prevention of infection. The labia minora are two smaller folds of skin on each side of the vaginal entrance. They contain no fat and are not covered by hair. The clitoris is a small structure seen at the top of the labia minora. The urethra lies between the vaginal entrance and the clitoris. Inside the labia minora, the vestibule is an area of smooth skin which contains the orifice of the urethra and the entrance to the vagina.

Women infected with either Chlamydia trachomatis or Neisseria gonorrhoea harbour the bacteria within the vagina, from the vestibule to the cervix. The vagina produces a constant stream of fluid from the walls of the vagina, and from the cervix during certain times in the menstrual cycle. The vaginal fluid is composed of mucus, the remains of dead cells, white blood cells, and a complex liquid that is secreted from the vaginal wall. The fluid leaves the body through the vagina, and will inevitably collect infective bacterial cells as it does so.

Men and women normally urinate regularly throughout the day, depending upon fluid input. During urination, women generally pass urine directly from the urethal opening into the toilet bowl, or otherwise. However, some passes over the area of the vestibule, washing away accumulated vaginal secretions, and accumulated bacterial cells. There will thus be a general correlation between accumulated cell levels and time since last urination. In order to collect as many bacterial cells, as possible therefore, the time between urination must be as long as possible. The best time to achieve this, therefore, is after a period of sleep. A urine sample taken first thing in the morning will collect the most bacterial cells per ml of urine than at any other time of the day. It also follows that during the first morning pass of urine, 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.

When asked to provide a urine sample, men have little difficulty in collecting an adequate sample, as the penis directs the urine flow. However, women face considerably greater difficulty. Urinating into a standard urine container is difficult, and given the potential infectivity of the sample, very unhygienic. The process may be aided by the use of a simple plastic funnel, such as that used in a science laboratory, but it is ungainly and still potentially unhygienic.

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.

However, this publication is largely concerned with the collection of urine for chemical analysis, where it is well established that it is desirable to collect a mid-stream sample. The publication discloses the device as an alternative to a prior art mid-stream sample apparatus, and in a practical embodiment the described device is specifically adapted for this by the provision of a stream diverter upstream of the collection aperture which diverts the low initial flow to void but collects the higher mid-flow into a sample container. For most urine analysis, mid-flow urine is preferred as it is more likely to be sterile, chemically representative, and less likely to be contaminated by bacteria or other extraneous protein sources.

It is an object of the invention to provide a device to facilitate collection of urine from women which mitigates some or all of the disadvantages of urination directly into a container or via a simple funnel device.

It is a particular object of the invention to provide a device adapted to facilitate collection of the first few ml of urine.

It is a preferred object of the invention to provide a device adapted to direct urine flow via the vestibule so as to increase the extent to which vaginal fluid containing bacterial cells for a target sexually transmitted disease is present in the sample, to provide a sample with a higher bacterial concentration offering greater diagnostic efficiency in screening tests for the said diseases.

Thus, in accordance with the invention at its broadest aspect there is provided 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.

For use 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.

In particular, the aperture is flush with the channel wall, and there is no projection from the channel wall into the conduit, either as an extension of any downwardly extending sample tube or otherwise, which might act as a partial barrier upstream of the sample collection aperture serving to deflect initial flow of urine, such as is known in prior art devices. Once the sample container is full, remaining urine passes along the conduit defined by the channel portion and is voided through the void outlet at a distal end of the channel portion.

The first principle in the design of the device in accordance with the invention is simply to contain the act of urination, so that urine may pass from the urethra into a collection device via the collection aperture, and then any surplus be directed to the toilet bowl. The woman may therefore both collect a urine sample and complete the act of micturition (urination) without any contamination of the hand with potentially infected urine. This is achieved in that the collector serves as a hood which will fit over the genital area, and preferably over the entire vulva, from the mons pubis to the perineum, and the perimeter of the labia majoris, to be held comfortably in place by the hand. The device will direct the flow of urine first to a collection outlet and further to the toilet bowl without any leakage.

The second principle in the design of the device in accordance with the invention is that the closure extending across the upper portion of the receptor hood will be constructed so that as the device is placed against the labia majora, it will seat over the urethral opening, extending at least part of the way, and preferably substantially fully, towards the vestibule of the vagina so as to direct the flow of urine into the labia minora and towards the vestibule of the vagina. This closure portion of the hood receptor will be directed and shaped to provide a solid barrier against the area of the urethra but to define a flow channel directing urine towards the vestibule. The closure portion is thus typically generally planar, extending from the upper perimeter of the hood across the upper part of the hood opening, but is conveniently provided with equilateral extensions which are adapted to sit comfortably engaged within the fleshy walls of the labia majora. This structure acts to prevent urine passing from the urethra passing beyond the clitoris, thereby forcing the urine flow down the labia minora, over the vestibule area at the entrance of the vagina, and thence towards the collection outlet and the ultimate void outlet and thence for example the toilet bowl.

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. In an infected woman, this initial sample, especially in the morning, will contain a higher concentrated sample of bacterial cells from a sexually transmitted disease.

This is effected in that 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.

For example the collection outlet is provided with a downwardly extending collection channel means, such as a downwardly extending tube or like conduit, having towards a distal end a container connector to effect such a substantially leak proof connection with a suitable sample container. In a preferred embodiment this comprises a screw threaded, bayonet, interference fit or other mechanical connection to engage with complementary means on the sample container.

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.

In use with a sample container attached, at least a substantial part of the initial urination is diverted via the sample collection outlet. However, once the container is full, the remaining urination will largely divert along the channel portion via the void outlet. The design thus facilitates collection of the first part of the urination only.

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. To that end, 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 chamiel portion has an aperture junction with and extends laterally at an angle away from the hood portion to create in combination a funnel-like structure. The channel portion defines a conduit for urine flow away from the receptacle form by the hood portion. The channel portion is of narrower and conveniently constant cross-section. The channel portion preferably comprises a walled tube or similar conduit, and is in particular conveniently a cylindrical tube. A void outlet is provided in the form of an aperture at its distal end, and a collection outlet in the form of an aperture in the conduit wall along its length.

The channel portion is preferably fabricated as a relatively rigid conduit, and may for example be fabricated from a different, more rigid material than that used for the relatively more flexible hood portion, or may be fabricated from the same material but of greater thickness and/or provided with additional structural elements to give rigidity. In accordance with the invention the hood portion and the channel portion making up the funnel structure are so formed that when the rim of the hood is held, in use, against the body of a female user, the channel portion is oriented downwards from the horizontal and generally parallel to the natural direction of flow of urine. References to horizontal, vertical, downward and upward directions made herein are for illustrative purposes and to be understood in the context of that use.

The channel portion preferably connects to the hood portion at a junction angle such as to project in use at an angle of about 110 to 155°, in particular about 125 to 135°, from an upright direction in use. The collection outlet then comprises an aperture so located in the channel wall so located as to be downwardly directed. A urine sample collection container can then be arranged to be coupled to the collection outlet to be substantially vertical when the apparatus is in use by a female sitting down.

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.

Although the device is ideally so structured that the collection outlet directs generally vertically down, so that the action gravity will assist in ensuring that any initial urination favours a path via the collection outlet, it is preferred that the junction of the channel portion of the funnel serving as the egress pipe from the area of the vulva and the collection aperture is itself structured further to encourage diversion of the initial stream so that in use a substantial part of the initial stream, at normal urination speeds and pressures, passes preferentially via the collection outlet and collection channel means to an attached sample container.

To this end, the collection outlet preferably incorporates or is associated with a raised flow barrier projecting into the fluid conduit defined by the channel portion so as to tend to divert urine flow preferentially to the collection outlet by acting as a partial barrier to flow towards the void outlet. This may take the form of a partial barrier around the perimeter of the collection outlet, but more preferably the collection outlet further comprises an extending collection channel means, such as a extending tube or like conduit, and the flow barrier takes the form of a projection lying across the outlet, for example over the median of the outlet aperture, and also extends into the collection channel means to serve as a septum dividing the same into two fluidly distinct flow channels.

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. Alternatively 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.

A device in accordance with the invention may be fabricated from any suitable materials, subject to the fluid requirements posed by the intended use. In one alternative, the device or modules thereof may be fabricated from sterilisable materials allowing for reuse, and in particular for example from sterilisable polymeric materials. Additionally or alternatively, the device or components thereof may be fabricated from disposable, and preferably biodegradable, materials. For example, materials based on cellulose fibre, such as paper, might be suitable. It is likely that such materials will require that all inner surfaces likely to contact with urine during use are given a fluid proof coating, which is preferably similarly suited for disposable, for example being biodegradable.

It is important if possible to retain this initial 10-30 ml sample intact and prevent dilution of that sample by further passing of urine. Therefore, 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. Conveniently 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. For example 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.

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. Conveniently, 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. For example, to facilitate application of a concentration method making use of magnetic coated particles, the sample container may contain an amount of magnetic particles coated with antibodies to one or more causative agents of sexually transmitted disease. The invention will now be described by way of example only with reference to Figures 1 and 2 of the accompanying drawings wherein: Figure 1 is a cross section about a longitudinal axis of an example device in accordance with the invention; Figure 2 is an end projection from the hood end of the device of Figure 1.

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.

During use, 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.

In use a suitable collection bottle is attachable to the collection tube 13 by means of an engaging portion 19 on the tube 13, for example being adapted for push- fit connection. Once this collection bottle is full, further urine is still able to flow along the rest of the channel means to the downward extension 14 and be voided through the aperture 15. The whole apparatus is so adapted that the collection tube 13 and downward extension 14 both lie essentially vertically downwards during normal use, with the main tubular portion 10 of the channel means being at an angle of around 130° from upright.

A suitable collection bottle is also shown on Figure 1 in an unattached configuration. The bottle comprises a tubular wall 21 closing to a neck 22 which is adapted to engage with the engaging portion 19 for use. Engagement is by push-fit, although a threaded, bayonet or other fitting may be used. The bottle includes a plastic disc float 24. As the bottle fills with urine this disc float rises to a point where it closes the neck aperture 25 and acts to restrict or prevent flow of further urine into the bottle, so that the collected sample, comprising the initial part of the urination cycle, is not diluted by later urination, and that later urination substantial entirely runs to void through the aperture 15. In the example, the bottle contains coated magnetic particles 26 suitable to facilitate application of the method of UK patent application number 0324953.9 or another similar method to the determination of the presence of target bacteria.

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. 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. For all these reasons, 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.

Claims

1. A urine collection device comprising a funnel having a relatively larger concave hood portion serving as a receptor for urine in fluid communication with a relatively narrower 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 at least one aperture in the side of the channel wall so placed as to be directed generally downwardly in use with the said perimeter so located.

2. A urine collection device in accordance with Claim 1 wherein the closure extends from the top of the hood opening perimeter, and over at least half of the area of the hood defined by the hood perimeter.

3. A urine collection device in accordance with Claim 1 or 2 wherein the junction aperture is 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.

4. A urine collection device in accordance with any preceding claim wherein the urine collection outlet is 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.

5. A urine collection device in accordance with any preceding claim wherein the collection outlet is provided with a downwardly extending collection channel means, such as a downwardly extending tube or like conduit, having towards a distal end a connector to effect a substantially leak proof connection with a suitable sample container.

6. A urine collection device in accordance with Claim 5 wherein the connector comprises a screw threaded, bayonet, interference fit or other mechanical connection to engage with complementary means on a sample container.

7. A urine collection apparatus in accordance with one of Claims 5 or 6 further comprising a suitable sample container attached and/ or provided in kit form with one or more such suitable sample containers adapted to be attachable thereto.

8. A urine collection device in accordance with any preceding claim wherein the hood portion is 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.

9. A urine collection device in accordance with any preceding claim wherein the hood portion exhibits 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.

10. A urine collection device in accordance with Claim 9 wherein the perimeter of the hood portion comprises a pubic contacting and locating portion at a first end of the longitudinal 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 enclose the area of the labia majora.

11. A urine collection device in accordance any preceding claim wherein the hood portion and the channel portion making up the funnel structure are so formed that when the rim of the hood is held, in use, against the body of a female user, the channel portion is oriented downwards from the horizontal and generally parallel to the natural direction of flow of urine, and connects to the hood portion at a junction angle such as to project in use at an angle of about 110 to 155°, from an upright direction in use.

12. A urine collection device in accordance with any preceding claim wherein the collection outlet is spaced along the channel portion away from its junction with the hood portion by at least 15 mm.

13. A urine collection device in accordance with any preceding claim wherein the collection outlet incorporates or is associated with a raised flow barrier projecting into the fluid conduit defined by the channel portion so as to tend to divert urine flow preferentially to the collection outlet by acting as a partial baπier to flow towards the void outlet.

14. A urine collection device in accordance with Claim 13 wherein the collection outlet further comprises an extending collection channel means, such as a extending tube or like conduit, and the flow barrier takes the form of a projection lying across the outlet over the median of the outlet aperture, and extends into the collection channel means to serve as a septum dividing the same into two fluidly distinct flow channels.