WO2018020197A1

WO2018020197A1 - A method of clinical assessment and apparatus therefor

Info

Publication number: WO2018020197A1
Application number: PCT/GB2017/000111
Authority: WO
Inventors: Dr Nicolas Paul BRYAN
Original assignee: Nicolas Bryan Limited
Priority date: 2016-07-25
Filing date: 2017-07-18
Publication date: 2018-02-01
Also published as: GB2555563B; GB2555563A; GB201612801D0; DE202017007158U1; EP3487408A1

Abstract

A method of clinical assessment of a patient is provided, primarily for the evaluation and diagnosis of lower urinary tract conditions. The method comprises the collection of urine voided by the patient at each micturition of the patient over a predetermined number of days. At each micturition the urine is collected in a single- use, disposable container (2) and the weight of the urine voided is measured and recorded in an electronic device (3), which also records the time and date of the aforementioned measurement, prior to disposal of said urine. Apparatus comprising said single-use, disposable container (2) and said electronic device (3) is also provided. The disposable container (2) is adapted for directly collecting urine voided by the patient and the electronic device (3) is adapted to measure and record the weight of said disposable container and its contents together with the time and date whereby the volume of urine voided at each micturition is calculated and recorded along with the time and date of said micturition. Preferably, the disposable container (2) comprises a biodegradable, water-resistant bag (4). This enables the disposable container and its contents to be hygienically disposed of after every micturition.

Description

A METHOD OF CLINICAL ASSESSMENT

AND APPARATUS THEREFOR

The present invention relates to a method of clinical assessment, in particular for the evaluation and diagnosis of lower urinary tract conditions, and apparatus therefor.

Lower urinary tract conditions relate to the storage and empting phases of the micturition cycle and usually require an assessment of bladder performance in order that they can be evaluated and correctly diagnosed. Such conditions include, for example, overactive bladder syndrome, stress or urge urinary incontinence, interstitial cystitis and male obstructive lower urinary tract conditions. Conventionally, such assessment is carried out by requiring the patient to keep accurate records of micturition that may include a micturition frequency volume chart, which involves the recordal of the date and times of micturition during the day and night and the volumes of urine voided at each event. Usually the patient is provided with a paper chart to complete and a measurement jug into which he or she urinates so the volume of urine can be measured. It will be appreciated that this is an unsatisfactory state of affairs. It is not convenient for use by patients outside the home and night-time records are often missed owing to patients tending to take less care when they are tired and sleepy both in measuring urine volume and in completing the paper chart. As a result most paper records kept by such patients are inaccurate and incomplete and therefore less useful than they would otherwise be if accurately kept.

It is an object of the present invention to provide a method of clinical assessment and apparatus for use in such a method that overcomes or substantially mitigates the aforementioned problems.

According to a first aspect of the present invention there is provided a method of clinical assessment of a patient comprising the collection of urine voided by the patient at each micturition of the patient over a predetermined number of days and characterised in that at each micturition the urine is collected in a single-use, disposable container and the weight of the urine voided is measured and recorded in an electronic device, which also records the time and date of the aforementioned measurement, prior to disposal of said urine.

According to a second aspect of the present invention there is provided apparatus for use in the method according to the first aspect of the present invention wherein the single-use, disposable container is adapted for directly collecting urine voided by a patient and the electronic device is adapted to measure and record the weight of said disposable container and its contents together with the time and date whereby the volume of urine voided at each micturition is calculated and recorded along with the time and date of said micturition.

Unlike conventional methods of assessment, it was realized by the applicant that the weight of the urine voided by the patient is a sufficiently accurate measure of its volume for the purposes of the assessment. Hence, apparatus can be used that avoids the need for the patient to make use of a measurement jug and that is more convenient and more hygienic than conventional methods. It also makes the apparatus readily portable and therefore more likely to be used by the patient when away from home.

Preferably, the disposable container comprises a biodegradable, water-resistant bag. This enables the disposable container and its contents to be hygienically disposed of after every micturition.

Preferably also, the electronic device comprises a weighing scale in the form of a strain gauge whereby the weight of the disposable container and the urine therein is weighed and recorded directly by the electronic device.

Other preferred but non-essential features of the present invention are described in the dependent claims appended hereto. The various aspects of the present invention will now be described by way of example with reference to the accompanying drawings, in which: Fig. l is a perspective view of an embodiment of apparatus for use in the method of the first aspect of the present invention and in accordance with the second aspect of the present invention;

Figs. 2 and 3 are side and perspective views respectively of a disposable container forming part of the apparatus shown in Fig. 1;

Fig. 4 is a perspective view of a modified disposable container and funnel; Fig. 5 is a perspective view of the funnel shown in Fig. 4;

Fig. 6 is a perspective view of the container shown in Fig. 4 when in use as a liner for a rigid urine collection container; Fig. 7 is front view of an electronic device for use in the method of the first aspect of the present invention and in accordance with the second aspect of the present invention; and

Fig. 8 is a perspective view of the device shown in Fig. 7 shown in an extended position as would the case when in use as a weighing scale as shown in Fig. 1.

The aim of the present invention is to facilitate data recordal by a patient to enable a medical practitioner to assess more accurately recorded data than has otherwise been the case. To this end, the method requires the patient to collect urine at each micturition over a predetermined number of days, as specified by the medical practitioner, making use of apparatus 1 in accordance with the invention. This apparatus 1 provides a single-use, disposable container 2 for the direct collection of urine as it is voided by the patient and an electronic device 3 that is adapted to weigh the collected urine and container and to record the time and date at the same time. The container is designed as a single-use container in order that it and its contents can be hygienically disposed of, for example by flushing down a lavatory after each micturition. The electronic device 3 is adapted to be interrogated by the medical practitioner, as described, below so that the recorded data can be considered and an assessment of it made. This apparatus 1 will now be described in more detail.

As shown in Figs. 1 to 3, the single-use, disposable container 2 comprises a bag 4 with a contoured mouth 5 and at least one and preferably two handles 6. The bag 4 is preferably creased at each side as at 7 so that it can fold flat and the handles 6 are respectively arranged on opposite sides of the folded bag 4 for ease of use. Preferably, the body of the single-use bag 4 is comprised of a biodegradable, water-resistant material, such as starch- impregnated paper, that will hold a quantity of liquid such as urine for a sufficiently long period without degradation to permit use but that will readily biodegrade over time. Hence, in practice the patient may be provided with a box of folded-up containers 2 for use during an assessment period. Also, as the containers 2 fold up, they can be discreetly carried by the patient, along with the electronic device 3, for use when away from home.

The contoured mouth 5 is formed by a contoured rim of the bag 4, which is higher at one side, namely the front, than the other side, namely the rear, to conform to the shape of the patient's crotch. This ensures urine is collected adequately when used by both men and women in a standing position. Advantageously, the contoured rim and adjacent portion of the bag 4 are reinforced by or formed by a collar 8. The collar 8 is preferably also comprised of a biodegradable, water-resistant material, such as recycled paper and moulded pulp or papier-mache, but is more rigid than the body of the bag 4 to which it is secured. In some embodiments, for example as shown in Figs. 4 and 5, the single-use bag 4 is adapted to be used in conjunction with a separate funnel 9 into which the bag 4 locates and that sits around the mouth 5 of the bag 4 when in use. The funnel 9 is also shaped to conform to the shape of a patient's crotch and can make the container 2 easier to use when the bag 4 is not provided with a rigid collar 8 as it assists in holding the mouth 5 open and in its adoption of a suitable shape when the handles 6 are pulled apart ready for use. The funnel 9 can be reusable and made of a plastics material so that it can be washed after use. Alternatively, the funnel 9 may also be made of a similar material to the collar 8 so that it can be readily disposed after either a single or multiple uses when appropriate.

In yet another embodiment, as shown in Fig. 6, the single-use bag 4 may be adapted to form a disposable liner for a rigid urine collection bottle or container 10. Such an arrangement is particularly suited for use in hospitals. Here again, the bag 4 need not be provided with a rigid collar 8.

As shown in Fig. 1, the handles 6 not only enable the patient to hold the container 2 during use but are then used to hook the container 2 on to the electronic device 3, which is provided with a hook 11 for this purpose, so that the bag and its contents can be suspended from the hook 11 and weighed. If a funnel 9 or a rigid urine collection bottle is used, the bag 4 is preferably detached from these prior to being weighed with its contents. The electronic device 3 will now be described in more detail with reference to Figs. 7 and 8.

The device 3 is preferably a battery- powered, electronic device that comprises a clock, a weighing scale and a means of storing and outputting data. It has a rigid plastics housing 12 that accommodates the electronics and one or more batteries. It is also provided in its upper part with an aperture 13 so that it can be readily held by a finger or hand and in its lower part with a strain gauge 14 that projects out of the housing 12 when in use but is otherwise retained within the housing 12. The hook 11 is operationally connected to the strain gauge 14 as it carries the load of the container 2.

In addition, the device 3 comprises a display 15, which may normally display the time and date but will also display the weight recorded by the strain gauge when the device 3 is in use. The device 3 is also preferably provided with two buttons 16, 17, that respectively comprise an on/off switch 16, which switches the device 3 on to record a new weight reading, and an "undo" switch 17, which will display and can delete a last reading made. When a reading is made by a user the weight of the container 2 and its contents are logged along with the date and time and stored within the device 3. As the weight of the container 2 is known and may be preprogrammed into the device 3, the device 3 can calculate the weight of the urine in the bag and therefore its volume. This data is stored along with all previous readings within the device 3 until it is the device 3 is reset. The data may be viewed using the display 15 but preferably the device 3 also comprises an output means whereby recorded data is accessed and downloaded to a computer. The output means may comprise a USB port (not shown) but preferably comprises an internal transmitter for the wireless transmission of recorded data to a remote receiving station, such as a medical practitioner's computer.

It will be appreciated that the apparatus described above is for use in method of clinical assessment of a patient by a medical practitioner. It enables the patient to collect urine at each and every micturition over a predetermined number of days in a convenient and hygienic manner and for the weight and therefore volume of the urine to be measured and logged along with the time and date of the aforementioned measurement. It obviates the patient having to measure urine volumes using a jug or similar measuring device and to keep paper records. It also ensures that the records kept are much more likely to be accurate and complete than conventional paper records.

Claims

1. A method of clinical assessment of a patient comprising the collection of urine voided by the patient at each micturition of the patient over a predetermined number of days and characterised in that at each micturition the urine is collected in a single-use, disposable container and the weight of the urine voided is measured and recorded in an electronic device, which also records the time and date of the aforementioned measurement, prior to disposal of said urine.

2. A method as claimed in Claim l, wherein said urine is disposed of along with the disposable container.

A method as claimed in Claim l or Claim 2, wherein data recorded in said electronic device is output to a computer for review by a medical practitioner.

A method as claimed in any of Claims l to 3, wherein data recorded in said electronic device is output by wireless transmission to a remote receiving station for review by a medical practitioner.

Apparatus for use in the method as claimed in any of Claims 1 to 4, wherein the single-use, disposable container is adapted for directly collecting urine voided by a patient and the electronic device is adapted to measure and record the weight of said disposable container and its contents together with the time and date whereby the volume of urine voided at each micturition is calculated and recorded along with the time and date of said micturition. 6. Apparatus as claimed in Claim 5, wherein the disposable container comprises a biodegradable, water-resistant bag. Apparatus as claimed in Claim 6, wherein the bag is a starch- impregnated cellulose bag.

Apparatus as claimed in Claim 6 or Claim 7, wherein the bag is creased so that it folds flat and two handles are respectively arranged on opposite sides of the folded bag.

Apparatus as claimed in any of Claims 5 to 8, wherein the disposable container has a mouth defined by a contoured rim which is higher at one side of the container than the other to conform to the shape of the patient's crotch.

Apparatus as claimed in Claim 9, wherein the contoured rim of the disposable container is reinforced by a collar.

Apparatus as claimed in Claim 9 or Claim 10, wherein the disposable container is adapted for attachment to a funnel that holds the mouth open.

Apparatus as claimed in any of Claims 5 to 10, wherein the disposable container is adapted to form a liner for a rigid urine collection bottle or container.

Apparatus as claimed in any of Claims 5 to 12, wherein the electronic device comprises a weighing scale in the form of a strain gauge whereby the weight of the disposable container and the urine therein is weighed and recorded directly by the electronic device.

Apparatus as claimed in Claim 13, wherein the electronic device comprises a hook from which the disposable container may be suspended and which is operationally connected to the strain gauge whereby the combined weight of the disposable container and its contents may be recorded. Apparatus as claimed in any of Claims 5 to 14, wherein the electronic device comprises an output means whereby recorded data may be downloaded to a computer.

Apparatus as claimed in any of Claims 5 to 15, wherein the electronic device comprises a transmitter for the wireless transmission of recorded data to a remote receiving station.