SPECIMEN COLLECTION APPARATUS

Field of the Invention

This invention relates to collection of specimens. It relates particularly but not exclusively to apparatus for use with a specimen collection container for collecting urine, semen or the like.

Background to the Invention

Many medical conditions can be diagnosed by testing a specimen of a patient's blood, urine, semen, saliva, sputum or other body fluid or tissue. In particular, urine samples are frequently used to test for a range of medical conditions and can also give a great deal of information about a person's overall health. Some of the medical conditions which may be detected by testing a urine sample include diabetes, urinary tract disease, kidney disease, kidney stones and cystitis to name a few. Urine samples can also be used in preliminary testing for pregnancy and to detect traces of certain drugs in a person's system.

Most urine specimens are collected mid-stream during urination. After the urine has flowed for several seconds, the subject places a specimen collection container into the stream and collects about 60 ml of "midstream" urine without interrupting the flow. When the required amount of specimen has been collected, the patient finishes urinating into the toilet or urinal. A lid is placed on the collection container and the container is labelled and sent to a laboratory for testing.

This procedure is considered unhygienic because of the need to hold the container in the urine stream during collection. Some systems have been devised whereby a rack is positioned over the toilet bowl and a specimen container is retained by the rack. However, since one individual's anatomy differs from the next, there is an inherent risk that an insufficient urine volume will be obtained, or that none of the urine will be collected because the geometry of the rack is not suited to the anatomy of the patient. The rack must also be cleaned before each use creating additional sterilisation and hygiene issues.

In general, collection of a urine specimen is more difficult for women because of their anatomy and limited ability to position correctly and fill the container. The procedure becomes even more complicated for pregnant women, and more so again for overweight patients. Children and patients with physical or intellectual disabilities often require assistance when giving a urine specimen, which can be unhygienic and undignified both for the patient and for the nurse, carer or assistant during collection of the specimen.

The present invention aims to provide a specimen collection apparatus which, in its various embodiments, provides a useful alternative for collecting a specimen.

Summary of the Invention

In a first aspect of the present invention, there is provided guide apparatus for use with a container for collecting a specimen. The apparatus includes a funnel portion, and a neck portion which is locatable inside an opening of the container. Attachment means is provided for attaching the guide apparatus to the container and a region of weakness facilitates separation of the funnel portion from the neck portion. The funnel portion of the guide apparatus can be separated from the neck portion at the region of weakness, after collection of the specimen.

The region of weakness may be provided in the form of a frangible line, perforations, a scored line or other line of weakness. Accordingly, the funnel portion may be separated from the neck portion by tearing along the weakness thus allowing closure of the container with a lid.

A second aspect of the invention provides guide apparatus for use with a container for collecting a specimen, the apparatus including a funnel portion, and a neck portion locatable inside an opening of the container. Attachment means is provided for attaching the guide apparatus to the container and at least the funnel portion of the guide apparatus is separable from the container after collection of the specimen. Separation of the guide apparatus from the container enables closure of the container by application of a lid.

In various embodiments, the attachment means includes adhesive to adhere the neck portion of the guide apparatus to an inner region of the container opening. The adhesive may be in the form of an adhesive strip applied to the neck portion and activated by removal of a waxed paper or other backing. Alternatively, the adhesive may be a gum activated by moistening with water or the like. In this embodiment, the adhesive may be activated by dipping the neck portion of the guide apparatus in water. It is to be understood, however, that any suitable attachment means may be used as an alternative.

The attachment means is sufficiently strong that in use, the container can be positioned for collection of a specimen by a user holding a portion of the guide apparatus without the container detaching from the funnel, even as the collected specimen increases the weight of the container.

The guide apparatus may be attached to a container well in advance of collection and prior to sterilisation of the container to ensure collection of an uncontaminated sample. Alternatively the guide apparatus may be attached to a container immediately prior to collection of a sample which may be convenient in some circumstances. Where the guide apparatus is attached to the container well in advance of specimen collection, it is preferable that the funnel portion is expandable from a storage configuration in which the guide apparatus is attached to the container and retained therein, permitting closure of the container by application of a lid. When a sample is to be collected, the lid is removed and the funnel portion is gently pulled, causing it to expand to an in- use configuration where the funnel portion guides the specimen being collected into the container.

The guide apparatus may further include biasing means to move the funnel portion from the storage configuration to an in-use configuration and/or to strengthen the funnel portion generally. The biasing means may be incorporated into an outer rim of the funnel portion. Alternatively, the biasing means may include a strip which extends between the neck portion and the

outer rim of the funnel portion. Such biasing means is preferably configured to operate upon release of the funnel portion from the storage configuration.

Preferably, the guide apparatus further includes a tab extending from the funnel portion and which can be held between a user's thumb and forefinger during collection of a specimen. This reduces the risk of the specimen becoming contaminated by contacting the user's fingers during collection. The tab may also be grasped by the user and used to expand the funnel portion from the storage configuration prior to use. Preferably the tab is provided on an outer rim edge of the funnel portion although it may alternatively project out from the funnel body.

In one embodiment the funnel portion has a split extending away from the neck portion. The split permits overlap of regions of the funnel portion thus enabling the funnel portion to assume and maintain the storage configuration. Preferably this is without crushing or otherwise mis-shaping the funnel portion. The split also enables the funnel portion to be assembled from a blank.

In an embodiment where the funnel portion has a split, a pair of tabs may be provided with one tab located either side of the split. Preferably, these tabs are designed in such a way that they slot together or interlock to form one easily operated tab. Preferably, the tabs are located on an outer rim of the funnel portion, either side of the split, and help to complete and maintain the shape of the funnel opening. Alternatively, the tabs may be located along the split. Preferably the funnel opening is elliptical in shape. This is particularly suitable for funnels used to collect urine samples from female subjects.

In one embodiment, the guide apparatus may include a flange configured to attach to the rim of the container. The flange may be an annular flange or consist of one or more flange sections. Preferably, the flange includes an internal threaded portion configured to engage with a thread on the container. Alternatively, the one or more flange sections may attach the guide apparatus to the container by engaging or "clipping" under the threaded portion of the container.

The guide apparatus may be removed from the container by disengaging the flange from the thread around the container opening e.g. by unthreading the annular flange or deforming the flange sections to release the guide apparatus from the container. Alternatively, the flange material may be sufficiently thin and conformable that a lid may be applied to the container's thread, over the flange.

In such an arrangement, a frangible portion (e.g perforations, a scored line or other region of weakness) between the neck portion/flange and funnel portion are desirable to facilitate separation of the funnel portion from the neck portion, prior to closure of the container by application of a lid.

In this arrangement, the flange may also help to form a better seal between the container and the lid, particularly when the flange includes a rubber, silicon, latex or other malleable material capable of forming a liquid-tight seal. Alternatively, the guide apparatus may further include a sealing member around the opening of the container for preventing leakage of specimen from the closed container. The sealing member may include a rubber, silicon or latex based product, or similar malleable material capable of forming a leak-proof seal around the container.

Alternatively, a band may be applied around the flange to attach the guide apparatus to the container. Such band may be, for example, an elastic band. The band can then be removed after collection of the specimen and prior to removal of the funnel portion and closure of the container with the lid.

The funnel portion may take any suitable form. In one embodiment, the funnel portion may be telescopically expandable from a storage configuration to an in- use configuration. Alternatively, the funnel portion may be pleated, facilitating radial expansion to an in-use configuration. In a previously described embodiment, the funnel portion includes a split which enables one "end" of the funnel portion to be wound into the rest of the funnel portion thereby reducing its overall radius to assume the storage configuration.

The guide apparatus may be manufactured from any suitable material or combination of materials. Such materials may include but are not limited to flexible plastic or other polymer, paper, wax-coated paper and silicon or rubber to name a few. Preferably the material is biodegradable so that the removed funnel portion (or indeed the entire guide apparatus) can be flushed down the toilet at completion of the specimen collection procedure. It is desirable that the material used does not contaminate or otherwise affect the specimen collected.

In another aspect of the present invention, there is provided a collection system for collecting a specimen. The system includes a container, lid and a guide apparatus having a funnel portion and a neck portion. The neck portion is retainable inside an opening of the container. Attachment means is provided for attaching the guide apparatus to the container. The guide apparatus has a storage configuration in which the funnel portion is collapsed inside the container permitting closure with the lid, and an in-use configuration in which the funnel portion is expanded for use in guiding the specimen into the container.

Preferably, at least the funnel portion is removable from the container after collection of the specimen. A region of weakness such as a frangible line or perforations may be provided between the funnel portion and the neck portion of the guide apparatus to facilitate easy separation of the funnel from the container after the specimen has been collected. The guide apparatus of the collection system and parts thereof may take any suitable form, including those previously described. The system may also include a sealing member around the container opening which prevents leakage of fluid from the container when the lid is fastened to close the container.

Another aspect of the present invention provides a blank for a guide apparatus, for use with a container for collecting a specimen. The blank includes a funnel portion and a neck portion extending from the funnel portion. A pair of interlocking tabs is provided with each tab disposed at opposing ends of the funnel portion. When assembled, the blank forms a guide apparatus suitable for use with a container for collecting a specimen.

Brief Description of the Drawings

The invention will now be described with reference to the following drawings. It is to be understood that the particularity of the embodiments illustrated in the accompanying drawings does not supersede the generality of the preceding description of the invention.

Figure 1 illustrates a specimen collection container and lid of the kind known in the art.

Figure 2 is an exploded view showing the container of Figure 1 with the lid removed and a guide apparatus according to an embodiment of the invention.

Figure 3 shows the guide apparatus of Figure 2 attached to a container.

Figure 4 shows the funnel portion of the guide apparatus of Figures 2 and 3 being removed from the container.

Figure 5 is a sectional view illustrating one embodiment of the invention having a biasing means.

Figure 6 illustrates an embodiment of the guide apparatus having a split and a pair of interlocking tabs.

Figure 7 is an exploded view of an alternative embodiment of the guide apparatus which has a flange.

Figure 8 is a blank for a guide apparatus according to an embodiment of the invention.

Detailed Description

Referring firstly to Figure 1 , a specimen collection container 101 is shown. The container 101 has an externally threaded portion (not shown) near its opening which engages an internal thread on the lid 102. This arrangement enables the

container to be sealed once a specimen such as a urine, semen or sputum sample has been collected.

Now referring to Figure 2, an exploded view of a container 101 and a guide apparatus generally referred to at 200 is shown. The guide apparatus has a funnel portion 201 and a neck portion 202. When the guide apparatus is attached to the container, neck portion 202 is retained inside the opening of the container 101. This minimises leakage of specimen between the guide apparatus and the container during collection.

Preferably, the guide apparatus is attached to the container using an adhesive 203 applied to the external surface of the neck portion. In one form, the adhesive is applied to the neck portion and activated by removal of a waxed paper backing (not shown). In another embodiment, an adhesive gum on the external surface of the neck portion is activated by moistening e.g. by dipping the neck portion in water. Other attachment means may be used as an alternative or in addition to the adhesive. One such alternative is described below in relation to the embodiment illustrated in Figure 7.

Perforations 204 are provided between the funnel portion 201 and neck portion 202 to facilitate easy separation of the funnel portion from the container after the desired amount of specimen has been collected, facilitating closure of the container with a lid. Alternatively, the entire guide apparatus (including the neck portion) may be removed from the container prior to closure with a lid. Figure 3 shows the guide apparatus of Figure 2 attached to a container.

The user holds the guide apparatus in position during collection of a sample by gripping tab 205 between the forefinger and thumb of one hand. In such use, the attachment means must be able to withstand the downward weight of the container during collection of the specimen to avoid uncontrolled separation of the guide apparatus from the container. Advantageously, by using the guide apparatus it is possible for the funnel portion to be held against the user's skin without contaminating the specimen being collected. After collection, the user holds the container in one hand and pulls the tab with the other hand to tear

along the perforations 204. Figure 4 shows removal of the funnel portion from the container by tearing along the perforations.

Preferably, at the time of specimen collection the guide apparatus has been pre-attached to a container, with the funnel portion collapsed inside the container, in a storage configuration. When in the storage configuration, the container 101 can be closed using lid 102. Advantageously, in such an embodiment the guide apparatus can be attached to a container 101 in advance of a specimen collection procedure and sterilised together with the container and lid. The guide apparatus is then made ready for use simply by removing the lid and expanding the funnel portion so that the guide means is in the in-use configuration. Any suitable folding arrangement may be employed to achieve a storage configuration. Alternatively, the guide apparatus may be provided separately to the container, and attached thereto prior to collection of a specimen.

Biasing means may be incorporated into the guide apparatus to urge the funnel portion to assume the in-use configuration. The biasing means may be made from any suitable material. Preferably it is a biasing spring and one which will not cause contamination of any collected specimen, although it is desirable to have no contact between the biasing means and the specimen being collected. In one embodiment it is a metal spring although a biodegradable biasing means may be preferable so that the funnel portion, when removed from the container, can be disposed of by e.g. flushing down the toilet. Other suitable materials include cardboard or stiffened/rolled paper with spring characteristics, and biodegradable plastics, polymers or the like. When the funnel portion is urged out of the storage configuration, the biasing means springs into shape, causing the funnel to open up to the in-use configuration.

Figure 5 shows a cross-sectional view of an embodiment of the invention with a biasing means 206 provided as a circular spring under a lip of the rim of the funnel portion at its opening. In this embodiment, the biasing means can be coiled or twisted upon itself when in the storage configuration and biased to form a ring when released from the storage configuration, thus causing the

funnel portion to assume the in-use configuration. Preferably, the ring is elliptical in shape as is the funnel opening when in the in-use configuration. In another embodiment, the biasing means may be provided in the form of a strip along a length of the funnel portion, rather than around its opening, or a combination of a strip and ring. The strip is bent or folded upon itself in the storage configuration and when released, the biased strip straightens causing the funnel portion to assume the in-use configuration.

The embodiment illustrated in Figure 6 shows a split 207 in the funnel portion. The split extends along the funnel portion, away from the neck portion of the guide apparatus and permits overlap of regions of the funnel portion when it is in the storage configuration. Figure 6 also shows a pair of tabs, 205a and 205b provided on the outer edge of the funnel portion. One tab 205a is located on one side of the split 207 and the other tab, 205b is located on the other side of the split. In use, the tabs 205a,b can be aligned so that they overlap (at least in part), thereby closing the split and holding the funnel portion in the desired funnel shape. The overlapping tabs can then be held by the user between the thumb and forefinger during specimen collection. In one preferred embodiment as illustrated, the tabs 205a,b are interlocking tabs.

Figure 7 illustrates an alternative embodiment of the guide apparatus. Here, a flange 208 is provided substantially parallel to the neck portion. The flange has attachment means in the form of an internally threaded wall 210 configured to engage with the external thread on the container. Using these matched threads, the guide apparatus can be attached to the container by threaded engagement. Advantageously, the neck portion of the guide apparatus still sits inside the container thereby preventing leakage of specimen between the guide apparatus and the container during specimen collection.

As an alternative, the thread may be omitted from the flange and the guide apparatus may be attached to the container by attaching a resilient band or seal around the flange. The external thread on the container assists in generating the friction required to attach the two parts. In another embodiment, the flange may engage the container just below the threaded portion.

To close the container after collection of a specimen, either the entire guide apparatus may be removed from the container (e.g. by unthreading the flange or removing the resilient band). Alternatively, the funnel portion may be removed by tearing along perforations 204, and the container sealed by applying the lid 102 over the flange 208 which remains over the container opening. To achieve this, the flange may also include an outer thread (not shown) configured to engage with the internal thread of the lid. Alternatively, the flange material may be sufficiently conformable that it can be compressed between the container and the lid whilst allowing engagement between the container and lid threads, through the flange material. This may provide an improved seal, especially where the flange includes a material such as rubber, silicon or latex, for example.

In one embodiment, the flange is attached to the funnel portion of the guide apparatus, above the region of weakness (e.g. perforation line) such that tearing along the perforations also removes the flange. To assist in such removal, a line of weakness may also be provided down the threaded wall of the flange, enabling it to tear open and come away from the container when sufficient tearing force is applied, along with the rest of the guide apparatus.

Figure 8 illustrates a blank 800 for a guide apparatus. The blank has a funnel portion 801 and a neck portion 802 which has slits 803 that extend from the edge of the neck portion toward perforation line 804. The slits enable the blank to be assembled with the neck portion forming a "ring" locatable inside a container opening. Preferably, one side of the neck portion has an adhesive layer for attaching the neck portion to the inside of the container. The adhesive may have a removable waxed or other backing strip on the adhesive layer to prevent the blank from becoming stuck to other blanks or the like prior to assembly.

The funnel portion of the blank has an overlap region A which enables the assembled blank to form a complete funnel. The overlap region A may include adhesive, although this is not essential due to interlocking tabs 805 which

interlock to maintain the guide apparatus in the assembled configuration. These tabs also provide a surface for the user to grip during use of the apparatus for collection of a specimen. The blank may be folded along fold lines B so that tabs 805 extend radially from the assembled funnel portion. Reinforced rim 806 extends around the funnel opening providing the assembled apparatus with a level of rigidity.

The guide apparatus may be made from any suitable material such as flexible plastic or other polymer, paper, wax-coated paper and silicon or rubber. However, it is desirable that the material is biodegradable to minimise the effect that use of the invention would have on the already large quantities of land fill being created by disposable medical supplies. In this regard, it would be even more desirable for the material to be sufficiently biodegradable to permit flushing of the removed funnel portion (or indeed the entire guide apparatus) down the toilet once the specimen has been collected. Clearly, the material used to manufacture any part of the guide apparatus should not affect or contaminate the collected specimen in any way.

For embodiments of the invention in which the funnel portion is expandable from a collapsed configuration, the funnel portion may take a number of different forms which permit the requisite collapsing and expanding. The funnel portion may be telescopically expandable to an in-use configuration, having ring portions of incrementally decreasing diameter, with one ring portion designed to sit inside the adjacent ring. Alternatively, the funnel portion may be pleated, facilitating radial expansion to an in-use configuration. In another embodiment, the material from which the funnel portion is manufactured is sufficiently conformable that it is simply folded or flattened into the container when in the storage configuration, and made to assume the in-use configuration using the biasing means.

It is to be understood that various modifications, additions and/or alterations may be made to the parts previously described without departing from the ambit and scope of the invention as described herein.