WO2012019214A1

WO2012019214A1 - Urine sampling

Info

Publication number: WO2012019214A1
Application number: PCT/AU2011/000842
Authority: WO
Inventors: Ralph Laby; Corinne D'agostino
Original assignee: Ralph Laby; D Agostino Corinne
Priority date: 2010-08-10
Filing date: 2011-07-06
Publication date: 2012-02-16

Abstract

A method of obtaining an indication of the properties of an individual's urine including positioning absorbent material (20) in proximity to the individual's urinary tract to absorb urine therefrom; removing the absorbent material; and instructing that the absorbed urine be analysed.

Description

URINE SAMPLING

FIELD OF THE INVENTION

The invention relates to the collection and analysis of an individual's urine.

The invention will be described in respect of the collection and analysis of a human individual's urine, although the invention has a broader application. By way of example various embodiments may suit veterinary applications.

BACKGROUND

The properties of an individual's urine can be of great diagnostic value. Accordingly it is not uncommon to take and analyse a sample of an individual's urine. Obtaining a sample from a healthy adult is straightforward. A healthy adult has sufficient mental capacity, dexterity and bladder control to easily give a sample of their urine by urinating into a conventional specimen jar.

Obtaining a sample of urine from the very old, the very young or the very ill can be difficult. Urine samples can be taken from a bedpan, although this approach has drawbacks. The very old pass very little urine and have little or no control of their bladders. As such delivering a sample can involve an extended period atop of the bedpan. Moreover the very old are often frail and there is a risk of significant injury, eg. a fractured hip, from sitting on and manoeuvring on and off a bedpan.

Obtaining a urine sample from the mentally ill, eg. elderly dementia patients, can be especially difficult. In extreme cases a catheter and physical restraint of the patient is required. This is distressing to the patient and a lengthy (and therefore costly) process, and being an invasive procedure poses not insignificant health risks.

The invention aims to at least in part address one or more of the above problems, or at least to provide an alternative in the marketplace. SUMMARY

The inventors have realized that absorbent material can be used to conveniently obtain a urine sample. According to preferred embodiments cotton fabrics are employed, although other materials such as various powders may be used. One aspect of the invention provides a method of obtaining an indication of the properties of an individual's urine including positioning absorbent material in proximity to the individual's urinary tract to absorb urine therefrom; removing the absorbent material; and instructing that the absorbed urine be analysed.

Another aspect of the invention provides a method of obtaining an indication of the properties of an individual's urine including positioning absorbent material in proximity to the individual's urinary tract to absorb urine therefrom; removing the absorbent material; and analysing the absorbed urine.

Either method may further include extracting the absorbed urine from the absorbent material prior to the analysis. Optionally the extracting the absorbed urine includes compressing the absorbent material in a piston and cylinder arrangement. Alternatively, the extracting the absorbed urine may include drawing a draw string of a device including the absorbent material.

Preferably the absorbed urine is sealingly packaged for transport to a facility for analysis of the absorbed urine. This might involve packaging the absorbent material, but preferably the absorbed urine is extracted and then packaged separately.

Another aspect of the invention provides a method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including: positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and sealingly packaging the absorbed urine for transport. Another aspect of the invention provides a method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including: positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and compressing the absorbent material in a piston and cylinder arrangement to extract the absorbed urine.

Another aspect of the invention provides a method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including: positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and drawing a draw string of a device including the absorbent material to compress the absorbent material to extract the absorbed urine.

Preferably the absorbent material is removed from a sealed and sterilized package prior to the positioning. Positioning the absorbent material may include positioning a pad including the absorbent material within a garment, by way of example the garment might be a nappy or a pair of underpants. Preferably the method further includes removing the absorbent material from the pad.

According to preferred forms of the invention the absorbent material is non- contaminating. "Non-contaminating absorbent material" and variants of these words as used herein refer to absorbent material which does not contaminate or otherwise affect the properties of the urine (or at least does not affect the properties of the urine which are of interest) whereby analysis of the absorbed urine yields substantially identical results to a like analysis of a urine sample obtained by other means. Contaminating absorbent material could be employed and the test results adjusted accordingly, e.g. adjusted by a known correction. The correction might be obtained from empirical study.

Various cotton fabrics (ie. fabrics which predominantly consist of cotton) have been found to be suitably non-contaminating. As will be described non-woven fabrics have desirable absorption characteristics. Typical menstrual pads and nappies are thought to include contaminating absorbent materials.

Another aspect of the invention provides a device for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the device including: non-contaminating absorbent material positionable in proximity to an individual's urinary tract to absorb urine therefrom; a draw string drawable to compress the absorbent material to extract absorbed urine.

Preferably the device further includes a layer of impermeable material outward from the absorbent material. Another aspect of the invention provides a device for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the device including: non-contaminating absorbent material positionable in proximity to an individual's urinary tract to absorb urine therefrom; a layer of impermeable material outward from the absorbent material.

A layer of permeable material inward from the absorbent material may also be included. Preferably the absorbent material is separable from other portions of the device. The device may further include an arrangement for fastening the device to the interior of a garment. The fastening arrangement might include an adhesive backing.

Another aspect of the invention provides a sealed and sterilized package including a device for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine.

Another aspect of the invention provides a garment for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the garment including: a nappy and absorbent material positionable within the nappy, to be in proximity to an individual's urinary tract, and being removable from the nappy. Another aspect of the invention provides a pad for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the pad being shaped to be positioned within a garment and including an absorbent material portion, the absorbent material portion being positioned to be in proximity to a urinary tract and removable from other portions of the pad.

Preferably a fastening arrangement by which the pad is fastenable to the garment is provided.

The pad is preferably provided in a sealed and sterilized package.

Another aspect of the invention provides a kit for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the kit including absorbent material positionable in proximity to an individual's urinary tract to absorb urine therefrom; and a piston and cylinder arrangement to extract the absorbed urine.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a plan view of a pad in accordance with an embodiment of the invention;

Figure 2 is an exploded cross-section view corresponding to the line A-A of Figure 1 ;

Figure 3 is a plan view of the pad of Figure 1 showing the absorbent material partly removed from the body of the pad;

Figure 4 is a cross-section view corresponding to the line B-B of Figure 3;

Figure 5 is a cross-section view corresponding to the line C-C of Figure 3; Figure 6 is a cross-section view similar to Figure 4 showing an alternative embodiment of the invention;

Figure 6a is a close-up view of detail D of Figure 6;

Figure 7 illustrates a kit in accordance with an embodiment of the invention in use; Figure 8 is a plan view of a pad in accordance with a further embodiment of the invention; and

Figure 9 is a plan view of a nappy in accordance with a further embodiment of the invention.

DESCRIPTION OF AN EMBODIMENT Figures 1 to 5 illustrate a urine sample collection device in the form of pad 10. Pad 10 is a thin web of material shaped to cover the genital area. The shape of pad 10 is similar to a conventional menstrual pad. When viewed in plan the pad 10 is an elongate member having convexly curved end portions connected by concavely curved side portions defining a central crotch or waisted region to suit human anatomy in the genital region.

It is contemplated that the pad should be supplied in three different sizes (small, medium and large) and that a single pad shape may suit both males and females.

The pad 10 includes a central elongate strip of absorbent material 20 running along its length. The strip of absorbent material 20 is surrounded by the casing 40. The casing 40 predominantly defines the remainder of the pad. The casing 40 includes an outward layer 60 (ie. the layer which is in use outward from the urinary tract), and an inward layer 50 (ie. the layer which is in use inward from the absorbent material toward the urinary tract). An absorbent layer 70 is sandwiched between the layers 50 and 60. The layer 70 is made up of two layer portions spaced from and positioned symmetrically either side of a central axis running along the length of the pad 10. The layers 50, 60 and the portions of absorbent layers 70 together define a central longitudinal elongate cavity in which the absorbent material 20 is carried. At least one end of this elongate cavity is open to facilitate removal of the strip of absorbent material 20 as will be described. In alternative embodiments the absorbent layer 70 may be omitted.

A length of tape 32 runs along the absorbent material 20 for most of the absorbent material's length and is bonded thereto. An end portion 32a of the tape 32 projects at one end of the pad from the elongate cavity to present a convenient gripable portion in the form of a gripping tab. Turning now to Figures 6 and 6a, preferred variants of the invention include an adhesive layer 82 outward from the layer 60 covered by a further layer 82' of backing paper. This arrangement serves to fasten the pad 10 to the inside of the patient's, i.e. the individual's, garment.

Figure 8 shows a pad 10' in accordance with a further embodiment of the invention carried within a sealed and sterilized package 100. The sealed and sterilized package 100 allows the pad 10' to be supplied to hospitals, or other health care providers, ready for use without onsite sterilization. According to preferred forms of the invention the pads (or other forms of collection devices to be described) are supplied in individual packages. The pad 10' differs from the pad 10 in that the tape and its end portion 32a are replaced by a length of string 34 arranged to present two gripable end portions 34a.

Figure 9 illustrates a nappy 10" in accordance with a further embodiment of the invention. The nappy 10" is similar to the pad 10' in that it includes a casing 42 defining a cavity in which a strip of absorbent material 20 is carried. The casing 42 includes a front portion 42a, and a back portion 42b, connected by a crotch portion 42c. When the nappy 10" is laid flat as in figure 9 the crotch portion 42c defines a narrow waist between the front and back portions 42a, 42b. Each side of crotch portion 42c is defined by a respective concavely curved gusset 42d.

The word "nappy" is used herein entirely interchangeably with the word "diaper" to refer to a garment for containing bladder and bowel movements. Such garments have a degree of absorbency sufficient to absorb a typical bladder movement. For the avoidance of doubt "nappy" or "diaper" takes in both nappies intended for the very young (eg. a newborn's nappy) and nappies for the very old (often referred to as "adult diapers").

The use of the illustrated embodiments and related methods in accordance with various embodiments of the invention will now be described.

The pad 10' of Figure 8 may be used to obtain an indication of the properties of the urine of a very old person. Typically the sterilized package 100 containing the pad 10' would be supplied to, say, an aged care facility such that the pad 10' remains sterile until the package 100 is opened. On site the package 100 can be opened, eg. by a nurse, before the backing paper 82' is removed and the pad 10' applied to an appropriate location in the crotch region of an adult nappy. In this way the adhesive layer 82 is used to fasten the pad 10' to the nappy.

The nappy may then be fitted to the patient in conventional fashion and in doing so the absorbent material 20 of the pad 10' is positioned in proximity to the individual's urinary tract to absorb urine therefrom.

After an elapse of time sufficient for urine to pass the nappy may be removed in conventional fashion. The absorbent material 20 is thereby removed from the patient and from proximity to the urinary tract. The elapse of time may be a fixed interval (e.g. in line with a conventional schedule of nappy changes), a period of time judged, e.g. by a nurse, to be sufficient for a sufficient volume of urine to pass, or judged by inspection of the nappy. Of course the nappy may be removed based on the patient reporting that they have passed urine if they are capable of doing so. It is contemplated that the wet absorbent material may be analysed to analyse the absorbed urine therein, but preferred that the absorbed urine is first extracted from the absorbent material and then analysed. This allows the urine to be analysed in conventional fashion. When using the embodiments 10 or 10', after the nappy has been removed from the patient the projecting end portions 32a, 34a of the tape 32 or drawstring 34 may be grasped to withdraw the strip of absorbent material 20 from the body 40 of the pad as in Figures 3 and 4. The removed absorbent material 20 may then be acted upon to extract the absorbed urine therefrom. As illustrated in Figure 8 the drawstring 34 follows an elongate U-shaped path to define the pair of string end portions 34a spaced from an apex 34b. In this embodiment the apex 34b is the only portion of the drawstring fastened to the absorbent material 20 whereby the string end portions 34a may be pulled in opposite directions to separately draw a respective portion of the string from the absorbent material such that the absorbent material 20 is bunched up and squeezed along the portions of string 34 remaining within the body of material 20. Thus, by applying force to (ie drawing) the draw string 34 the absorbed urine may be squeezed from the absorbent material 20. Of course a variety of other lacing patterns are possible. Figure 7 illustrates an alternative preferred mode of extraction. The absorbent material 20 is placed within a piston and cylinder arrangement in the form of a syringe 6. Of course the syringe need not be fitted with a needle. The material 20 is placed within the cylinder of the syringe and the plunger is advanced to compress the material 20 so as to squeeze the absorbed urine from the material 20 and to drive this urine outwardly through the outlet of the syringe 6 and into suitable packaging 8.

Urine analysis is often conducted at specialist pathology facilities which may be geographically separated from the location at which the urine sample is taken. Preferably the packaging 8 is suitable for transport to the hospital's pathology department or the offsite pathology testing facility. This requires that the interior of the package 8 be clean and sterile and that the package be sealable to prevent spillage and contamination of the urine carried thereby. A conventional specimen jar is a sealable package suitable for transporting urine. The use of the syringe 6 is convenient in the context of a hospital wherein syringes are accessible from existing supply streams.

Of course it is also possible that the urine might be tested onsite, eg. the wet absorbent material could be contacted with a test strip, or absorbed urine extracted from the material could be dropped onto a test strip. By way of example, urine may be tested onsite, with a form of test strip known as a ward strip, and sent offsite for further testing if this initial, onsite, test indicates an abnormality. In an aged care facility apparently healthy patients may be so tested about once a month or so.

When the absorbed urine is to be analyzed by a facility, eg. the hospital's pathology department or an offsite testing facility, rather than tested by a nurse onsite, the urine may be passed on with instructions for it to be tested. Typically, in a hospital environment there is an established workflow for processing biological samples. By way of example, simply placing a labeled specimen jar containing urine on a cart destined for the pathology department may constitute instructing that the urine be analysed. The instructions may specify the properties of interest, which may include one or more of specific gravity, leukocytes, nitrites, protein, glucose, keytones, urobilingogen, bilirubin, blood and haemoglobin.

In the illustrated embodiments the outer layer 60 is urine impermeable to prevent or limit the amount of urine being passed to surrounding garments. Polyethylene is thought to be a suitable impermeable material. The absorbent layer 70 is used as an overflow region to absorb/contain passed urine beyond what can be absorbed by the strip of material 20. In this embodiment the strip of material 20 is about 2cm wide by about 20cm long and 3mm thick. This strip is sufficient to yield an ample volume of urine for testing. Typically about 1 mm of urine in the bottom of a specimen jar is sufficient.

The inner layer 50 separates the skin of the patient from the layers of absorbent material 20, 70. Desirably the inner layer 50 is urine permeable and configured to quickly wick away urine whereby the individual's exposure to urine is reduced. This helps to reduce skin conditions that would otherwise occur when absorbent material wet with urine is held in contact with skin.

As described, preferred variants of the invention incorporate an absorbent material configured to absorb urine, and release the absorbed urine when compressed. It is desirable that the device and the absorbent material be configured to hold urine under low load conditions, and then release the urine when the loading, ie. the amount of squeezing is increased. By configuring the device to hold onto urine during low loading conditions the amount of urine squeezed out of the device by the normal movement of the patient is reduced. The collection device 10' may be supplied in a kit form. By way of example, the package 100 may also include one or more of a syringe 6, package 8, and testing equipment for testing urine (eg. a test strip).

Preferred forms of the invention are single use. This means that they must not be reused. Accordingly preferred variants are labeled single use. An appropriate label might be the numeral 2 surrounded by a circle spanned by a diagonal line striking out the 2. The label may be a physical label, as in a sticker attached to the product, or a marking made in some other way such as embossing or printing.

Claims

CLAIMS:

1. A method of obtaining an indication of the properties of an individual's urine including positioning absorbent material in proximity to the individual's urinary tract to absorb urine therefrom; removing the absorbent material; and instructing that the absorbed urine be analysed.

2. A method of obtaining an indication of the properties of an individual's urine including positioning absorbent material in proximity to the individual's urinary tract to absorb urine therefrom; removing the absorbent material; and analyzing the absorbed urine.

3. The method of claim 1 or 2 further including extracting the absorbed urine from the absorbent material prior to the analysis.

4. The method of claim 3 wherein the extracting the absorbed urine includes compressing the absorbent material in a piston and cylinder arrangement.

5. The method of claim 3 wherein the extracting the absorbed urine includes drawing a draw string of a device including the absorbent material.

6. The method of any one of claims 1 to 5 further including sealingly packaging the absorbed urine for transport to a facility for analysis of the absorbed urine.

7. A method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and sealingly packaging the absorbed urine for transport.

8. The method of claim 7 further including compressing the absorbent material in a piston and cylinder arrangement to extract the absorbed urine.

9. The method of claim 8 further including drawing a draw string of a device including the absorbent material to compress the absorbent material to extract the absorbed urine.

10. The method of claim 8 or 9 wherein the urine is so extracted prior to the sealingly packaging for transport

11 . A method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and compressing the absorbent material in a piston and cylinder arrangement to extract the absorbed urine.

12. A method of obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the method including positioning absorbent material in proximity to an individual's urinary tract to absorb urine therefrom; removing the absorbent material; and drawing a draw string of a device including the absorbent material to 5 compress the absorbent material to extract the absorbed urine.

13. The method of any one of claims 1 to 12 further including removing the absorbent material from a sealed and sterilized package prior to the positioning.

14. The method of any one of claims 1 to 13 wherein the positioning the absorbent material includes positioning a pad including the absorbent material within a

10 garment.

15. The method of claim 14 wherein the garment is a nappy.

16. The method of claim 14 or 15 further including removing the absorbent material from the pad.

17. The method of any one of claims 1 to 6 wherein the absorbent material is non- 15 contaminating.

18. The method of any one of claims 1 to 17 wherein the absorbent material predominantly consists of cotton.

19. The method of any one of claims 1 to 18 wherein the absorbent material is a non-woven fabric.

20 20. The method of any one of claims 1 to 19 wherein the individual is a human.

21 . A device for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the device including non-contaminating absorbent material positionable in proximity to an individual's urinary tract to absorb urine therefrom; a draw string drawable to compress the absorbent material to extract absorbed urine.

5 22. The device of claim 21 further including a layer of impermeable material outward from the absorbent material.

23. A device for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the device including non-contaminating absorbent material positionable in proximity to an 10 individual's urinary tract to absorb urine therefrom; a layer of impermeable material outward from the absorbent material.

24. The device of any one of claims 21 to 23 further including a layer of permeable material inward from the absorbent material.

25. The device of any one of claims 21 to 24 wherein the absorbent material is 15 separable from other portions of the device.

26. The device of any one of claims 21 to 25 further including an arrangement for fastening the device to the interior of a garment.

27. The device of claim 26 wherein the fastening arrangement includes an adhesive backing.

20 28. The device of any one of claims 21 to 27 wherein the absorbent material predominantly consists of cotton.

29. The device of any one of claims 21 to 28 wherein the absorbent material is a non-woven fabric.

30. The device of any one of claims 21 to 29 wherein the individual is a human.

31 . A sealed and sterilized package including the device of any one of claims 21 to 29.

32. A pad for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the pad being shaped to be positioned within a garment and including an absorbent material portion, the absorbent material portion being positioned to be in proximity to a urinary tract and removable from other portions of the pad.

33. The pad of claim 32 further including a fastening arrangement by which the pad is fastenable to the garment.

34. A sealed and sterilized package including the pad of claim 33.

35. A kit for obtaining a sample of urine to be analysed to obtain an indication of the properties of the urine, the kit including absorbent material positionable in proximity to an individual's urinary tract to absorb urine therefrom; and a piston and cylinder arrangement to extract the absorbed urine.