GB2340940A

GB2340940A - Collecting device for biological samples

Info

Publication number: GB2340940A
Application number: GB9820943A
Authority: GB
Inventors: Dermot Christopher John Barrow
Original assignee: Individual
Current assignee: Individual
Priority date: 1998-09-25
Filing date: 1998-09-25
Publication date: 2000-03-01
Anticipated expiration: 2018-09-25
Also published as: GB2340940B; GB9820943D0

Abstract

The device comprises: a first portion which is dished or bowl-like in form and has a peripheral rim disposed around a collection area; a second portion co-operating with the first portion to form a seal with the peripheral rim so as, in use, to contain a sample within the volume defined between the portions; a third portion adjoining said first and said second portions and formed so that the first and second portions are brought together to form the seal. The device has at least one assay rod, or has means for permitting insertion of a rod into the collecting area, the arrangement being such that, in use, the rod contacts the sample and may be removed from the collecting area for inspection and/or analysis after the seal between said first and second portions has been made. Sample is typically faeces, urine or sputum.

Description

SAMPLE COLLECTION This invention relates to the collection of biological

samples and in particular (though not exclusively) to the collection of samples of human or animal faeces, urine or sputum. The invention will be described hereinafter with particular reference to the collection of human faecal samples, it being understood that the invention is not restricted to this use.

Research has shown that the collection of human and animal bio-waste materials is unhygienic, distasteful to humans, and a positive inhibition in the early recognition, analysis and treatment of diseases identifiable or carried in faeces, urine and sputum.

For example, identifying occult-blood in human faeces is a possible early warning indicator to the possible existence of colo-rectal cancer in a patient. However, collection of the faecal material is too often resisted by the patient due to embarrassment and discomfort in collecting a viable sample; this in turn causes delay in obtaining diagnosis, possible exacerbating their condition from one which is probably treatable to one which may be untreatable.

Delays in receiving data back concerning the sample contribute to further patient anxiety and possibly extend delay to a critical point.

Colo-rectal cancer is now seen as one of the most virulent cancers in the industrial world with deaths increasing annually. The usual method of diagnosis is by way of an expensive and potentially painful endoscopy.

It will be apparent that there is a need for a sample collection device which as far as possible overcomes the embarrassment experienced by the user, and which permits quick and hygienic collection of samples. 5 According to one aspect of the present invention, there is provided a device for receiving biological samples, which device comprises:

a first portion which is dished or bowl-like in form and which has a peripheral rim disposed around a collection area; a second portion shaped so as to be able to cooperate with said first portion and to form a seal with the peripheral rim thereof so as, in use, to contain a sample within the volume defined between said cooperating first and second portions; a third portion adjoining said first and said second portions and formed such that said first and second portions may be brought together to form said seal; wherein said device is provided with at least one assay rod extending into the collecting area, or is provided with means for permitting insertion into the collecting area of at least one assay rod, the arrangement being such that, in use, said assay rod contacts the biological sample and may be withdrawn from the collecting area for inspection and/or analysis after the seal between said first and second portions has been made.

As indicated above, the device is particularly useful for collecting samples of faeces, urine or sputum.

Preferably, one or more assay rods is or are pre-set in place within the device. For example, a pair of assay rods may be secured to the second portion ("lid") of the device - for example by a snap-in-place fitting so that, when the lid is closed to make the seal with the first portion ("bowl") of the device, the assay rods make contact with the sample in the bowl. The snap fitting may take the form of an arcuate recess formed on the edge of the lid portion, into which recess the rod fits tightly. A co-operating recess may be formed in the corresponding part of the rim of the bowl portion so that the rod is held even more securely once the bowl and lid portions come together and form a seal.

Once the device of the invention has been used to collect a sample, it can be hygienically transported to (for example) a pathology laboratory or to a surgery where the or each assay rod may be removed from the device for inspection or analysis. The rod(s) may be removed by releasing their snap-in-place fitting, or by cutting the edge of the device, or by any convenient means.

Advantageously, the first, second and third portions of the device are integrally formed. The overall form of the device may be generally shelllike, the third portion of the device constituting a foldable zone permitting the first and second portions to be brought together.

Preferably, the first, second and third portions are formed of a cellulosic material, e.g. cardboard. The cardboard may be corrugated or fluted.

Where the device is formed of acellulosic material, those surfaces of the device which, in use, make contact with the sample are coated with a material serving to render it impermeable to biological fluids. For this purpose, a water-impermeable adhesive may be 5 used, e.g. a natural or synthetic latex.

A preferred form of construction of the device of this invention has the third portion constituting a bridge between the first (bowl) and second (lid) portions.

The seal between the first (bowl) portion and the second (lid) portion of the device may, for example, be a mechanical seal and/or an adhesive seal. A suitable mechanical seal can be formed by forming a ridge around the edge of one of portion and a recess around the edge of the other portion, the ridge and recess coming together to form a male/female lock when the bowl and lid are brought together.

The ability to have an assay rod in the sample collecting device offers significant advantage in terms of speed of completing a test procedure, e. g. to determine whether there is blood within a faecal sample. The assay rod(s) thus offer a pre-diagnosis system for the early detection of occult blood in faeces in a simple, inexpensive and passive manner that causes the patent neither pain nor embarrassment. The information may be available almost immediately from the patient's General Medical Practitioner or hospital.

The safe and simple disposal of biological samples after analysis is no less a problem whether they be faeces, sputum or urine. Preferred embodiments of the present invention can be disposed of, after use, simply by flushing them down the lavatory and hence into the associated sewage system. When formed of suitable materials, e.g. a cellulosic material coated on its inner surfaces with a water-impermeable latex (which can be of adequate strength and with suitable waterabsorbing and softening characteristics while still able to carry a biological sample in a fluid-tight manner), the device is completely biodegradable and thus disposable through the sewage system without causing a blockage at the disposal site or at the sewage processing site.

Devices in accordance with this invention may thus be used as a low-cost screening devise for vulnerable persons with genetic or a family predisposition to specific diseases.

For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:

FIGURE 1 is a plan view of one embodiment of the device in its open configuration; FIGURE 2 is a side elevational view of the device of 25 Fig. 1 in its closed configuration; and FIGURE 3 is a side elevational view of the device of Figs. 1 and 2 in a partially open configuration.

Referring to the drawings, the device comprises a first portion 1, a second portion 2 and a third or connecting portion 3. These are all formed of micro-fluted cardboard. The inner surfaces of the device (i.e. those visible in Fig. 1) are coated with a thin film of a synthetic latex adhesive (not shown) which is waterimpermeable and acts as a contact adhesive. The third or bridge portion 3 has preformed fold lines 4a, 4b and 4c to permit the lid portion 2 to be folded over onto the bowl portion 1, passing through the configuration of Fig. 3 to give that of Fig. 2. In this configuration, the latex coating seals the lid portion to rim 5 of the bowl portion 2.

Assay rods (not shown) are provided; these may be secured to the lid portion or to the bowl portion.

Preferred sampling methods will now be described as they are applicable to in (1) faecal, (2) urine, and (3) sputum samples. The device used in these examples is generally as illustrated in the drawings.

Example 1 - Faecal Analysis The preferred device consists of a cardboard container manufactured from micro-fluted corrugated card which is formed into a first portion (bowl or shell) and attached thereto a second portion (top or lid). It resembles (visually) an oyster shell. The inside of the shell is coated with a thin artificial latex coating. This thin coating inside coating is both waterproof and self- adhesive.

The outside of the shell is not coated at all. The outer wall is manufactured of thin, non-waterproof paper material that collapses when soaked in water; and the collapse is accelerated by any flushing action. The reverse side of the corrugation channels is also not coated and collapses when in contact with water.

In addition, two high-absorbency card assay rods are attached with perforated tearaway strips so as to extend into the deepest point inside the bowl.or shell portion.

After a stool is collected, the lid is shut and self5 seal.s; any urine present may then be drained off -----through the rim of the container, where drainage holes may be prd- indented.

The p,re-place-d assay rods are pulled away from the shell and placed in an accompanying 7 - 10 ml vial counting a standard blood reagent (5% solution of hydrogen peroxide). The device of the. invention and its contents are then simply disposed of through the normal action of flushing it away through a lavatory basin or sluice.

The vial has a drip-proof lip and a screw top cap. Once the assay rods are placed in the solution and the lid firmly tightened, any excess material is simply torn away by the edge of the cap.

The colour of the reagent solution is light blue. Any occult blood present on the assay rods when placed in the solution, appears as a silver mark on the rod. The vial is surrounded by an adhesive label and is deliberately designed to only be available and checkable through a GP or Hospital.

In a typical regime, three devices are provided to be used once daily over three day period. The first day is to introduce the patient to a meat-free regime, and to allow for clearing the patient's stomach. The second and third day are the important days when the devices are returned to the GP's Surgery or to a Hospital/Clinic for visual observation and response.

The physical design of the shell is intentionally designed so that it may be presented from either the front or back of a patient whilst he or she is sitting comfortably over the lavatory. The lid portion acts both as a handle by means of which the patient holds the device and also as a "splash-guard". The closure of the lid prevents both smell and physi(-al contact with the collected sample. The "handle" means that most people irrespective of their shape or size will be able to place the shell in the optimum position for satisfactory sampling.

Where larger samples are required, especially in a hospital environment for other pathology, laboratory or microscope examination or tests, built-in sampling spoons may be used to place appropriate amounts in associated containers for safe and discrete delivery to the laboratory.

Example 2 - Urine Analysis The collection of urine samples is no less fraught with problems for a patient. Its disposal afterwards presents similar problems to those described above in relation to faecal sampling. By using a device in accordance with this invention, samples may be obtained for the purpose of a series of well-established tests, for example those associated with pregnancy or diabetes; or for detecting the presence of drugs and/or alcohol; or for supplying discrete sample bottles for onward pathological diagnosis. The collection process is simple, hygienic and without embarrassment for the patient. The assay rods used for urine testing are adapted for their intended function, e.g. to show by means of a colour change the presence of glucose in the 1 -gurine sample.

Example 3 - Sputum Analysis The collection of sputum - infected or otherwise is no less a difficult and sensitive area. A number of commonly available tests exist to analyse sputum. The major problem is the safe collection and subsequent disposal of potentially infectious materials.

A device in accordance with this invention facilitates the collection, isolation and disposal of sputum samples and can be used in association with existing diagnostic techniques using conventional reagents. It is thus a simple and easy task to isolation sputum samples for detection of conditions such as drug or alcohol abuse.

Claims

CLAIMS:

1. A device for receiving biological samples, which device comprises: 5 a first portion which is dished or bowl-like in form and which has a peripheral rim disposed around a collection area; a second portion shaped so as to be able to cooperate with said first portion and to form a seal with the peripheral rim thereof so as, in use, to contain a sample within the volume defined between said cooperating first and second portions; a third portion adjoining said first and said second portions and formed such that said first and second portions may be brought together to form said seal; wherein said device is provided with at least one assay rod, or is provided with means for permitting insertion into the collecting area of at least one assay rod, the arrangement being such that, in use, said assay rod contacts the biological sample and may be removed from the collecting area for inspection and/or analysis after the seal between said first and second portions has been made.

2. A device as claimed in claim 1, wherein said first, second and third portions are integrally formed.

3. A device as claimed in claim 1 or 2, wherein the device is generally shell-like in form, the third portion of the device constituting a foldable zone permitting the first and second portions to be brought together.

1 I I j

4. A device as claimed in claim 1, 2 or 3, wherein said first, second and third portions are formed of a cellulosic material.

5. A device as claimed in claim 4, wherein said cellulosic material is cardboard.

6. A device as claimed in claim 5, wherein said cardboard is corrugated or fluted. 10

7. A device as claimed in any preceding claim, wherein those surfaces of the device which, in use, make contact with said sample are coated with a material serving to render it impermeable to biological fluids. 15

8. A device as claimed in claim 7, wherein said material is a water-impermeable adhesive.

9. A device as claimed in claim 8, wherein said 20 adhesive is a natural or synthetic latex.

10. A device as claimed in any preceding claim, wherein said third portion constitutes a bridge between said first and second portions. 25

11. A device as claimed in claim 1 and substantially as hereinbefore described.

12. A method of testing biological samples, 30 substantially as hereinbefore described.