WO2021142510A1

WO2021142510A1 - Improved continence pad

Info

Publication number: WO2021142510A1
Application number: PCT/AU2021/000004
Authority: WO
Inventors: Floyd Gomes; Clement Lau
Original assignee: C Lau Pty Ltd
Priority date: 2020-01-15
Filing date: 2021-01-15
Publication date: 2021-07-22

Abstract

The present invention is a urine capture device adapted to be held directly against the abdomen of a person using the device and capture any urine emanating from the person. The device including a first-pass flow chamber, a mid-stream chamber and an overflow chamber and a conduit that is adapted to permit urine to flow sequentially from chamber to chamber. The first-pass flow chamber is adapted to only hold at least 2mls of the initial flow of urine emanating from the wearer, and then once the first-pass flow chamber has reached capacity, additional flow of urine emanating from the wearer is then directed to flow via the conduit into the mid-stream chamber. The mid-stream chamber is adapted to separately contain a urine sample sized portion of the additional flow. Once the mid-stream chamber is at capacity, any additional flow of urine is then directed via the conduit into the overflow chamber.

Description

Improved Continence Pad

Field of the Invention

[0001] This invention relates to the field of urine sampling and analysis, and in particular to sampling and analysis of people who are infants, incoherent and/or demented.

Background of the Invention

[0002] It has always been difficult to obtain urine samples from infants and confused or demented patients at hospitals and aged care facilities and the like. The reasons for this are varied, but fundamentally stem from the fact that it is common for this patient group to be incontinent of urine and faeces and be uncooperative with care givers.

[0003] Urinary tract infections (UT1) are also common among this group of patients. Diagnosing and treating UTIs effectively by medical professionals depends largely upon obtaining urine samples. In the absence of a reliable urine sample, when a urinary infection is suspected, options for the medical professional to manage the patient whittle down to:

1. Hypothesising that a urinary tract infection is present and treating with antibiotics empirically. This potentially exposes the patient to the unnecessary use of antibiotics which can lead to medication burden, side effects, financial loss and increases the risk of antibiotic resistance in the community.

2. Hypothesising that a urinary tract infection is not present and choosing to not use antibiotics. This delay, in the case of an elderly patient who actually does have a urinary tract infection, can allow that infection to progress and spread. Sepsis may ensue, increasing the likelihood of that resident needing to be transferred to hospital, and/or undergo more invasive or severe treatment than would otherwise be required if the UTI was treated sooner. By delaying treatment, these vulnerable patients suffer i.e. from bladder spasm and urinary symptoms.

[0004] When a medical professional asks for a urine sample, the typical procedure is summarised as follows: 1. In order to provide a more accurate urine sample, medical practitioners can resort to requesting that nursing staff obtain that sample by performing an “in and out catheter”. This practice refers to the insertion of a hollow silicon tube (catheter) directly into the urethra of a patient and advancing it sufficiently up the urethra so as to reach the bladder. Once it does so, a sterile sample of urine begins to drain and is collected. As could be expected, the confused or demented patient is usually most resistive to an in and out catheter procedure and it requires at least three staff to carry out the procedure. The whole thing is not only traumatic for both the patient and staff, but also clearly time and effort consuming, and despite best attempts, prone to failure in the case of a highly resistive patient.

2. Nursing staff may resort to other less invasive methods to collect a urine sample. These would include: a. Using a "witches hat" to catch urine as a patient sits on the toilet seat b. Condom draining - for male patients only c. The wringing of continence pads to extract captured urine. d. In the case of infants, there is also a paediatric type of urine catcher too, which basically comprises a bag which sticks on around the penis or vulva.

[0005] All of these existing "less invasive" methods are suboptimal as there is a high chance of contamination occurring thereby rendering the sample results unreliable and prone to false positives. When the results of a urine sample are reported by the pathology laboratory, there is a measure of epithelial cells which are superficial skin cells. Since there should be few skin cells within the bladder itself, the number of epithelial cells is provided as a guide as to the sterility of the urine sample itself. These epithelial cells originate from distal segments of the urethra. This area is thought to be contaminated with bacteria. For this reason, when providing a urine sample, a patient is asked to start urinating first, and then, whilst mid stream, start collecting urine in the sample pot. The initial contaminated urine is referred to as "first pass" and considered contaminated and likely to contain epithelial cells as a marker of this. The sterile sample beyond this (devoid of epithelial cells) is referred to as "mid-stream".

[0006] However, in the setting we describe relating to a confused or demented patient, all of this can get blurred, and a medical practitioner, anxious to improve things for the patient and trying to account for the limitations of "non-invasive" urine sample collection, can and often does choose to treat positive urinary tests with antibiotics, irrespective of whether the sample shows "contamination/epithelial cells" on the laboratory report. Therefore, once again, in the current environment, patients are at risk of being over treated with antibiotics.

[0007] Nursing staff may choose to simply ignore the request and basically wait for the health care practitioner to "forget about it". This sounds odd, but where it is highly unlikely that a sample can be collected in a "non-invasive" way, and an in and out catheter has been deemed too invasive, a stalemate does arise, and the request slip for the sample remains on a pinboard, possibly for months, with the urine sample ultimately never being collected.

[0008] It is therefore an object of the present invention to provide a device that is capable of obtaining accurate urine samples that ameliorates at least some of the aforementioned problems.

Disclosure of the Invention

[0009] Accordingly, in a preferred embodiment, the present invention is a urine capture device adapted to be held directly against the abdomen of a person using the device and capture any urine emanating from the person. The device including a first-pass flow chamber, a mid-stream chamber and an overflow chamber and a conduit that is adapted to permit urine to flow sequentially from chamber to chamber. The first-pass flow chamber is adapted to only hold at least 2mls of the initial flow of urine emanating from the wearer, and then once the first-pass flow chamber has reached capacity, additional flow of urine emanating from the wearer is then directed to flow via the conduit into the mid-stream chamber. The mid-stream chamber is adapted to separately contain a urine sample sized portion of the additional flow. Once the mid-stream chamber is at capacity, any additional flow of urine is then directed via the conduit into the overflow chamber.

[0010] Preferably, the urine captured in the mid-stream chamber is isolated from any other urine contained within the device and the environment within the mid-stream chamber is substantially hygienic and protected from external contamination.

[0011] Preferably, the first-pass flow chamber includes sealing means that seals the first- pass flow chamber once it has reached capacity so that subsequent flow of urine bypasses the first-pass flow chamber and flows directly into the mid-stream chamber. [0012] Preferably, the mid-stream chamber includes sealing means that seals the mid-stream chamber once it has reached capacity, so that subsequent flow of urine bypasses the second chamber and flows directly into the overflow chamber.

[0013] Preferably, the sealing means for either chamber is adapted to react to contact with urine.

[0014] Preferably, the sealing means includes expanding material that swells when in contact with urine and wherein the sealing means in the first-pass flow chamber is adapted to seal the first-pass flow chamber at a faster rate than the sealing means in the mid-stream chamber is adapted to close once the mid-stream chamber reaches capacity.

[0015] Preferably, the mid-stream chamber includes sample extraction means that enable a health care professional to extract at least a portion of the mid-stream urine sample contained within the mid-stream chamber.

[0016] Preferably, the mid-stream chamber includes a mid-stream chamber outlet, and wherein the mid-stream chamber outlet is connected to a urine extraction tube that extends out from the device and wherein the distal end of the sampling tube includes closure means that are both airtight and watertight.

[0017] Preferably, the closure means are adapted to interengage with a urine extraction tool. The tool is adapted to hygienically connect to the closure means and allow the extraction of at least a portion of the mid-stream urine stored within the mid-stream chamber.

[0018] Preferably the urine capture device includes a litmus indicator strip that is visible to a health care professional. The strip is adapted to indicate the presence of urine, and it is also adapted to provide a basic indication of any one or more of the following indicators:

• the presence of an infection, and/or

• the presence of white bloods cells, red blood cells and/or nitrites, and/or

• the volume of urine in the second absorbent pad so that attending medical professionals will have an indication that there is a sufficient volume of urine in the sample, and/or

• to indicate a minimum volume of 5ml of urine in the mid-stream chamber. [0019] Preferably, the device includes a faeces barrier that is adapted to keep any faecal matter in a separate area of the device away from the urine area of the device.

[0020] Optionally, counter means are included that are adapted to record the frequency of urination of the wearer while they are wearing the device.

[0021] Preferably, the counter means includes a visual display that is visible from the exterior of the continence pad while the pad is being worn, and the counter means is adapted to count every distinct separate occasion that urine passes out of the external urethral opening of the wearer, thereby providing a reliable number of separate instances of urination that are then displayed as a number on the visual display.

[0022] Optionally, the device includes logic control and memory means that are adapted to record and store the time and date of each urination of the wearer while the device is being worn.

[0023] Preferably, sensor means are included that are adapted to engage with the urine contained within the mid-stream chamber and sense qualitative and/or quantitative data and send that data back to the logic control and memory means for analysis to determine if an infection is present.

[0024] Preferably, the logic control and memory means are adapted to analyse the type(s) of bacteria detected in the urine and compare that bacteria type against a database of commonly used antibiotics to determine the most effective antibiotic to affect the determined bacteria type.

[0025] Optionally, an electrode is included that is adapted to sense the frequency and intensity of the electrical activity of the muscle wall of the bladder of the wearer, and that data is passed to the logic control and memory means so that the rate and intensity of each bladder spasm can be analysed.

[0026] Preferably, wireless communication means are included that are adapted to communicate: a) urination event count, and/or b) the results of the analysis of the urine sample, and/or c) the frequency and intensity of the electrical activity of the muscle wall of the bladder of the Wearer, and/or d) volume of urine, and/or e) the type of bacteria and its associated most effective antibiotic, to a program on a computer, including a hand-held device such as a tablet or smart phone wherein the display of the program on the computer provides a user or care provider with a “treat” or “do not treat” recommendation.

[0027] Preferably, a hand-held device is adapted to send the data it receives via the wireless communication means to the cloud or remote computer/machine for further analysis.

[0028] Optionally, the cloud or remote computers/machine is capable or using artificial intelligence and machine learning techniques to combine ancillary equipment monitoring the patient’s medical status, including cardiac, liver and renal status, in order to continuously improve its diagnostic capabilities.

[0029] Preferably, the device is adapted to be included in either a pad or garment worn by a person.

[0030] In another preferred embodiment, the present invention is a method of obtaining a substantially sterile urine sample from a person using a urine capture device incorporated into either a pad or garment worn on the body of a person from which the urine sample will be taken, wherein said device includes a first-pass flow chamber and a mid-stream chamber connected via a conduit, said method including the following steps: a) preparing the person for the application of the pad or garment to their body by first cleaning the area around their urethral opening, then b) applying the pad or garment to the person ensuring that the person’s urethral opening is properly orientated with respect to the urine capture device, then c) waiting for a urination event to occur, then d) extracting urine from the mid-stream chamber into a suitable sterile container for subsequent analysis of the urine sample extracted.

[0031] In another preferred embodiment, the present invention is a continence pad assembly to be worn by a person and adapted to hygienically and safely store urine emanating from the wearer. The continence pad including a first absorbent pad portion, and a second absorbent pad portion, and a conduit. The first absorbent pad portion and the second absorbent pad portion are connected by the conduit. The first absorbent pad portion is adapted to receive the first flow of urine out of the wearer’s urethra, and is adapted to only have a comparatively small capacity that is capable of only receiving and containing the first portion of the person’s entire urinary output during a normal urination, and once the first absorbent pad portion has reached its storage capacity, the subsequent portion of the person’s urinary output from the person’s urethra overflows the first absorbent pad portion and flows into and along the conduit, and then flows into the second absorbent pad.

[0032] Preferably, the first absorbent pad portion is adapted to be in direct contact with the urethral opening of the wearer to that is directly receives the first flow of urine from the wearer.

[0033] Preferably, the first absorbent pad portion is adapted to contain about the first 2mls of urine passing from the wearer during a normal urination, thereby causing the first absorbent pad portion to capture and store only the “first pass” urine flow from the wearer.

[0034] Preferably, the overflow of urine, known as “mid-stream” urine flows through the conduit into the second absorbent pad portion and the second absorbent pad portion is adapted to receive and contain the mid-stream urine in a substantially sterile environment.

[0035] Preferably, the length of the conduit is at least 30cm.

[0036] Optionally, a chemical barrier is included in at least the first absorbent pad, but not the second absorbent pad.

[0037] Preferably, the membrane which separates the faeces zone from the urine zone may also use a chemical barrier to stop the transfer of bacteria.

[0038] Preferably, an impermeable membrane is included that is adapted to isolate at least the second absorbent pad portion from any faecal contamination emanating from the wearer during, before or after urination. [0039] Preferably, a litmus indicator is included and in contact with the urine contained within the second absorbent pad portion and is configured so that it is visible from the exterior of the continence pad when the pad is worn, and is adapted to indicate the presence of urine by changing colour and thereby give the medical professionals attending to the wearer a visual indication that urination has occurred and whether there is evidence of infection or not.

[0040] Preferably, the litmus indicator is adapted to indicate the presence of urine, and it is also adapted to provide a basic indication of the presence of an infection.

[0041] Preferably, the litmus indicator is also adapted to indicate the presence of white bloods cells, red blood cells and nitrites in the urine sample.

[0042] Preferably, the litmus indicator is also adapted to indicate the volume of urine in the second absorbent pad so that attending medical professionals will have an indication that there is a sufficient volume of urine sample.

[0043] Preferably, the litmus indicator is adapted to indicate a minimum volume of 5ml of urine in the second absorbent pad portion.

[0044] Preferably, the second absorbent pad portion includes a normally closed opening that is located on the exterior of the continence pad, and wherein said closed opening is adapted to be opened when the urine contained within the second absorbent pad portion is extracted.

[0045] Preferably, the normally closed opening is adapted to securely interconnect with and make a liquid tight seal with the lid of a urine jar or a test tube.

[0046] Preferably, the interconnection of the lid of the urine jar or test tube is adapted to force the normally closed opening to open.

[0047] Preferably, the opening is configured to allow at least a portion of the urine contained within the second absorbent pad portion to be removed into an external sterile container.

[0048] Preferably, the second absorbent pad portion includes compression means that are adapted to compress the second absorbent pad portion and thereby cause urine to be expelled from the second absorbent pad portion through the opening.

[0049] Preferably, the compression means are adapted to simultaneously substantially close the proximate end to the second absorbent pad portion of the conduit as it compresses the second absorbent pad portion.

[0050] In one preferred form of the present invention, the compression means include a drawstring that has an internal portion and an external portion wherein the distal end of the internal portion is attached to the distal sidewall of the second absorbent pad portion so that when the external portion of the drawstring is pulled, it pulls the distal sidewall towards the proximate sidewall, thereby forcing the urine to be expelled through the opening.

[0051] In another preferred form of the present invention, one end of the urine jar or test tube is adapted to screw onto the normally closed opening, and the screwing action is adapted to also provide a compression force upon the second absorbent pad thereby forcing a portion of the urine to flow into the urine jar or test tube.

[0052] In another preferred form, the present invention is a continence pad assembly for use over a set period of time, no longer than 3 hours, including all the features of the first form and also including a third absorbent pad portion that is adapted to drain away any first flow urine contents from the first absorbent pad portion thereby recovering its capacity to receive the first flow urine from a subsequent urination.

[0053] Preferably, the first and third absorbent pad portions are interconnected by wicking means that are adapted to enable the first-pass urine contents of the first absorbent pad portion to wick away from the first absorbent pad portion and into the third absorbent pad portion.

[0054] Preferably, a fourth absorbent pad portion is included and is adapted to receive any overflow urine flowing from the second absorbent pad portion once the second absorbent pad portion has reached its urine storage capacity.

[0055] Preferably, counter means are included that are adapted to record the frequency of urination of the wearer while they are wearing the continence pad. [0056] Preferably, the counter means includes a visual display that is visible from the exterior of the continence pad while the pad is being worn, and the counter means are adapted to count every distinct separate occasion that urine passes out of the external urethral opening of the wearer, thereby providing a reliable number of separate episodes of urination that are then displayed as a number on the visual display.

[0057] In yet another form, the present invention has a combination of features already recited in the previous forms and also including logic control and memory means that are adapted to record and store the time and date of each urination of the wearer while the continence pad is being worn.

[0058] Preferably, sensor means are included that are adapted to engage with the urine contained within the second absorbent pad portion and sense qualitative and/or quantitative data and send the data back to the logic control and memory means for analysis.

[0059] Preferably, the logic control and memory means are adapted to take any qualitative data collected and determine if an infection is present.

[0060] Preferably, the logic control and memory means are adapted to analyse the type(s) of bacteria detected in the urine and compare that bacteria type against a database of commonly used antibiotics to determine the most effective antibiotic to affect the determined bacteria type.

[0061] Preferably, an electrode is included that is adapted to sense the frequency and intensity of the electrical activity of the muscle wall of the bladder of the wearer, and that data is passed to the logic control and memory means so that the rate and intensity of each bladder spasm can be analysed.

[0062] Preferably, wireless communication means are included that are adapted to communicate: a) urination count, and/or b) the results of the analysis of the urine sample, and/or c) the frequency and intensity of the electrical activity of the muscle wall of the bladder of the wearer, and/or d) volume of urine, and/or e) the type of bacteria and its associated most effective antibiotic, to a program on a computer, including a hand-held device such as a tablet or smart phone. The display of the program on the computer provides a user or care provider with a “treat” or “do not treat” recommendation.

[0063] Preferably, the hand-held device is adapted to send the data it receives via the communication means to the cloud or remote computers/machine for further more sophisticated analyses.

[0064] Preferably, the cloud or remote computers/machine is capable or using artificial intelligence and machine learning techniques to combine ancillary equipment monitoring the patient’s medical status, including cardiac, liver and renal status, in order to continuously improve its diagnostic capabilities.

[0065] In yet another form, the present invention is a method of obtaining a substantially sterile urine sample from a person using a continence pad having a first absorbent pad portion and a second absorbent pad portion, and a conduit interconnecting each portion, the method including the following steps: a) preparing the person for the procedure by cleaning the area around the urethral opening, then b) applying the continence pad to the person ensuring that the person’s urethral opening is substantially in direct contact with the first absorbent pad portion so that the first flow of urine flowing out of the urethral opening during a urination directly fills the first absorbent pad portion, and all subsequent flow of urine from the urethral opening overflows from the first absorbent pad potion, into and along the conduit and then into the second absorbent pad portion, then c) at the end of the urination, removing the continence pad from the person and transferring some or all of the contents of the second absorbent pad portion into a urine sample jar or test tube for subsequent analysis.

[0066] In yet another form, the present invention is a method of obtaining a substantially sterile urine sample from a person using a continence pad having a first absorbent pad portion and a second absorbent pad portion, and a conduit interconnecting each portion, and a draw string having an internal portion and an external portion, where the distal end of the internal portion is attached to the distal sidewall of the second absorbent pad portion and is adapted to move the distal sidewall towards the proximate sidewall when the external portion of the draw string is pulled, a normally closed opening that allows the urine contents of the second absorbent pad portion to drain, and a litmus paper indicator that is externally visible when the continence pad is being worn, the method including the following steps: a) preparing the person for the procedure by cleaning the area around the urethral opening, then b) applying the continence pad to the person ensuring that the person’s urethral opening is substantially in direct contact with the first absorbent pad portion so that the first flow of urine flowing out of the urethral opening during a urination directly fills the first absorbent pad portion, and all subsequent flow of urine from the urethral opening overflows from the first absorbent pad potion, into and along the conduit and then into the second absorbent pad portion, then c) observing the litmus paper indicator to determine:

• when urination has occurred; and

• any early indication of infection or no infection; and

• that there is at least 5ml of urine available in the second absorbent portion that may be extracted. d) opening the normally closed opening by attaching a suitable urine sample jar or test tube, then e) extracting the urine sample.

[0067] In yet another form, the present invention is a method of obtaining a substantially sterile urine sample from a person and also obtaining associated data surrounding urination frequency over a set period of time using a continence pad having a first absorbent pad portion and a second absorbent pad portion, and a conduit interconnecting each portion, a normally closed opening that allows the urine contents of the second absorbent pad portion to drain, a counter that has an externally visible display when the continence pad is being worn, said counter displaying the total number of urinations that have occurred over a set period of time, the method including the following steps: a) preparing the person for the procedure by cleaning the area around the urethral opening, then b) applying the continence pad to the person ensuring that the person’s urethral opening is substantially in direct contact with the first absorbent pad portion so that the first flow of urine flowing out of the urethral opening during a urination directly fills the first absorbent pad portion, and all subsequent flow of urine from the urethral opening overflows from the first absorbent pad potion, into and along the conduit and then into the second absorbent pad portion, then c) noting the time that the continence pad was applied, then d) waiting a set time no longer than 3 hours, then e) observing the counter to record the total number of urinations over the waiting period, then f) attaching a suitable urine sample jar or test tube to the normally closed opening, thereby forcing it open, then extracting a sample of urine from the second absorbent pad portion.

Brief Description of the Preferred Embodiments

[0068] Figures 1 (a) and (b) show sectional side views of a male and female variant of a preferred embodiment of the present invention.

[0069] Figure 2 (a), (b), (c) and (d) illustrates, in isometric and side sectional view, an illustration of another form of the present invention showing different stages of urine flow and capture.

Disclosure of the Preferred Embodiment

[0070] Turning firstly to Figure 1(a) & (b). In these views, we are shown a sectional view of a continence pad 1 being worn by a person. The section line is in the mid-inguinal area bisecting the left and right halves of the torso. The variant of the continence pad for use on males, correlating to Figure 1 (a) will be first described. It can be seen that the continence pad is placed upon the male so that the urethral opening 15 of the head of the penis 13 is in close proximity with the first absorbent pad portion 3. The scrotum is at 17 and the anus is shown at 19. Any urine flowing out of the urethral opening 15 flows into the first absorbent pad portion 3. This is called the first-pass urine. The liquid capacity of the first absorbent pad portion 3 is comparatively small, only around 2ml and is designed to capture the first pass urine only. Once the capacity limit of the first absorbent pad portion is reached, any further flow of urine from the urethral opening 15 overflows into the conduit 7. This urine flow is known as mid-stream and it is this urine that is the most suitable for analysis. In this preferred embodiment, the conduit 7 is approximately 40cm long and is winded so as to reduce the space it occupies. The flow of mid-stream urine flows through the conduit and flows into the second absorbent pad portion 5. The length of 40cm is chosen because common pathogenic bacteria found to cause urinary tract infection (including e.coli) travel at approximately 10cm per hour. Therefore, this length of tube buried within the substance of the urine zone, is a specific design feature that factors in the rate of bacterial tracking back to the second urine sample portion. An impermeable barrier 21 keeps the urine collected separate from any faecal material passed by the wearer while wearing the continence pad. Faeces is stored in the faeces zone 41. If the second absorbent pad portion 5 reaches its capacity, any overflow of urine is able to flow into the excess urine overflow tube 25.

[0071] In another preferred embodiment, the first absorbent pad portion 3 may be connected to an unsterile urine storage zone 25. This may be via a wicking means. This allows the first absorbent pad portion 3 to drain so that it has capacity to receive urine from a subsequent urination event while the pad is being worn.

[0072] A litmus paper indicator 29 is located on the continence pad 1 so that any changes in its appearance, indicating the presence of urine in the second absorbent pad portion 5, are visually observable by a health care professional while the continence pad 1 is being worn. A litmus paper indicator wick connects the second absorbent pad portion 5 to the litmus paper indicator 29. The litmus paper indicator may be configured to also roughly indicate the presence of an infection, and also the quantity of urine stored in the second absorbent pad portion.

[0073] In another preferred embodiment, a drawstring 11 is included that has an internal portion and an external portion. The distal end of the internal portion is attached to the distal sidewall of the second absorbent pad portion 5 so that when the external portion of the drawstring 11 is pulled, it pulls the distal sidewall towards the proximate sidewall, thereby forcing the urine to be expelled through the normally closed opening 9. The normally closed opening 9 is configured to interengage with the lid of a modified urine sample jar, or test tube. The action of attaching either the jar or test tube has the effect of opening the normally closed opening 9. This allows the sterile mid-stream urine to pass into the jar or test tube for subsequent lab analysis.

[0074] In another preferred embodiment, an electrode 35 is included that is adapted to sense the frequency and intensity of contractions of the bladder 33.

[0075] Additionally, a separate counter sensor 39 may be included and located near the urethral opening 15. The counter sensor 39 is adapted to count the number of separate urination events emanating from the urethra. It may be configured to display the count on the counter display 37

[0076] In another preferred embodiment, logic control and memory means 31 are integrated into the continence pad 1. These are in the form of a microchip. An extra sensor may be included in the second absorbent pad portion 5 that is adapted to provide rudimentary analysis of the urine stored in the second absorbent pad portion 5.

[0077] The logic control and memory means 31 are capable of storing 1) urination event count, 2) urinalysis, 3) EBG, 4) urine volume and 5) antibiotic sensitivity. In this preferred embodiment, the present invention includes wireless communications means that enable results to be communicated via near field technology, Bluetooth or via similar wireless technology means to 1) a handheld device or 2) directly to a computer. In this sense, the continence pad will be part of the 'internet of things' movement. The results contained in the logic control and memory means will be considered by a machine algorithm to give the user/ clinician an overall point of care decision to treat or not to treat for a UTI whilst the formal laboratory results are pending. This recommendation "treat" or "do not treat" will be immediately displayed on a screen (computer or handheld device) for the clinician to see, and it may also inform the clinician which antibiotic to use.

[0078] Furthermore, the data from individual continence pads of the type that are subject to the present invention may be de-identified and aggregated to allow a machine algorithm to be refined over time to keep improving point of care decision making. For example, it is hypothesised that the level of ketones which is a measure of dehydration will need to be considered against urinary frequency. A dehydrated patient may simply not urinate as frequently. This may prove to be true or untrue. Aggregation of data from multiple continence pads will help us answer such questions. Future sensors may be added to the continence pad in addition to the five inputs already identified above will be fed into the logic control and memory means potentially leading to even more enhanced machine learning and more accurate point of care decision making. The chip may also include protein / albumin count to tell the medical care professional about liver/kidney health. Cardiac health may also be indicated via proteome analysis.

[0079] Now turning to Figure 1(b) where we are shown the female variant. It includes all the same features as the male variant, except where structural modifications are made to best cater to the anatomical differences. In this variant, any discharge from the vaginal opening 45 are kept separate from urine passing out of the urethral opening 15. A vaginal foam pad 43 is included and a barrier keeps the urethra and the vagina separated.

[0080] Now turning to Figure 2 (a), (b), (c) and (d) where we are shown yet another preferred embodiment of the present invention. In this embodiment, we see a disposable garment in the shape of a nappy or diaper 47. The garment 47 is adapted to be worn by the patient. It comes in a variety of sizes and shapes to suit the size of the body of the patient, from baby size, through toddler and child size, up to young adult and fully grown adult. The garment includes fastening means 49 to ensure the garment 47 is properly secured to the body of the patient. At the base of the garment 47 is a urine capture portion 51. The urine capture portion 51 includes an opening 53. The opening 53 is connected to a conduit 55. The conduit 55 is adapted to enable urine 79 to flow from the urine capture portion, initially into a first-pass flow chamber 57, as indicated by the arrow in Figure 2(b). The first-pass flow chamber 57 is sized to only contain about the first 2mls of urine flow. This is known as the first-pass flow. The first-pass flow chamber 57 includes automatic sealing means that are adapted to react to contact with the urine thereby causing it to expand and close off the first- pass flow chamber 57. Subsequent flow of urine, known as the mid-stream flow then continues down the conduit 55 where it then flows into the mid-stream chamber 61 as indicated in Figure 2(c). The mid-stream chamber 61 is sized to hold a sufficient sample amount of mid-stream urine to enable analysis of the sample. The mid-stream chamber 61 includes second mid-stream chamber closure means 63. These means also react to coming into contact with the urine in the mid-stream chamber 61. The mid-stream chamber closure means 63 are adapted to close off the mid-stream chamber 61 from the urine flow in the conduit 55 after a sufficient amount of mid-stream urine has flowed into the mid-stream chamber 61. After the mid-stream chamber closure means 63 have closed off the mid-stream chamber 61, any additional urine flow then continues down the conduit 55 and flows out of the conduit 55 through the conduit overflow outlet 65 and into an overflow chamber 71 where the overflow urine is retained. Optionally, the garment 47 may also be fitted with a litmus indicator 77. The litmus indicator 77 gives the care giver a visual indication that a urination event has occurred. It may also be adapted to give some qualitative and quantitative indication relating to the urination event and assist the care giver in determining if a urine sample is ready to be retrieved from the mid-flow chamber 61. A flexible urine extraction tube 67 is pre-attached to the mid-flow chamber outlet 69. Prior to extraction of urine from the mid-flow chamber 61, the flexible urine extraction tube 67 is stored against the side of the garment 47. The distal end of the flexible urine extraction tube 67 has tube closure means 73 that maintains a liquid and airtight seal. Optionally, the tube closure means 73 are adapted to interengage with urine sample extraction means 75.

[0081] As shown in the preferred embodiment, the present invention ameliorates at least some of the aforementioned problems in addition to being simple, efficient and cost effective to use in order to obtain a sterile sample of urine of sufficient sample size to allow for testing and to be non-invasive and therefore cause no discomfort to the patient.

[0082] The present invention is a specially designed continence pad that has features which allow it to capture, store and test a sample of sterile urine which can then be sent for formal laboratory confirmation. The features of the product which will allow it to achieve this are: a) A simple pad or garment that is easy to manufacture and easy to use. b) Reduced likelihood of external contamination. c) Automatically captures first pass urine and stores it separately d) Automatically captures a sample size portion of mid-stream urine flow. e) Overflow occurs through a "urine disposal overflow tube" and kept separately from the sample of mid flow urine sampled. f) This urine zone within the pad or garment is kept separate from the "faeces zone". g) The optional counter feature that enables the pad or garment to capture the valuable symptom of urination frequency which is presently not considered in our target population. Within the three hours that the continence pad is worn, there will be a counter that tracks every distinct separate occasion that urine passes out of the external urethral orifice, thus providing a reliable number of separate episodes of urination within that three hour period. This provides a measure of urinary frequency. The continence pad will manually display this number (ranges 0-5, 5-10 episodes etc) on the front of the pad for the nurse to record. That number will also be captured by optional logic control and memory means that may also be included in the continence pad.

[0083] Preferably the continence pad is able to be worn for up to 3 hours. This is because pathology laboratories stipulate that urine samples need to be stored in a refrigerator after four hours.

[0084] In one of the various forms of the present invention, the present invention helps with point of care decision making to treat or not to treat for a UTI.

[0085] In addition to offering a visual display of the litmus test result, as is typically seen on a urine dipstick, the optional logic control and memory means is also capable of providing rudimentary analyses of a sample of sterile urine from a qualitative and quantitative perspective. This point of care urinalysis results in significantly decreasing human error.

[0086] Further, an optional electrode is included in the continence pad and located at the front and upper location. The electrode acts as a simple probe used to measure the electrical activity of the muscle wall of the bladder. The frequency and intensity of bladder wall activity is able to be captured by the electrode, giving rise to what we shall hereby describe by the term Electro-bladdo-gram (EBG). The EBG will provide a measure of the rate and intensity of bladder spasm. This figure should correlate to urinary frequency, but additionally helps capture the symptom of "dysuria" since it is likely that increased bladder spasm will also contribute to pain. Once again, the results of the EBG will be stored by the logic control and memory mean and be available immediately to the health care professional.

[0087] The present invention may also be configured to provide a measure of volume of urine. Because the urine zone is separated from the faeces zone, the continence pad or garment will be able to provide an approximate measure of urine volume. This measure will be manually displayed on the pad surface itself, as well as being captured by the logic control and memory means. [0088] In the case when the logic control and memory means determines that an infection is present, it will have the capability of testing that sample of urine against a panel of commonly used antibiotics, for example trimethoprim and cephalexin, and give a simple result of the sensitivity of that sample to those antibiotics. By doing this it will be possible to promote the use of narrow spectrum, and more targeted antibiotics from the outset, and avoid the use of broad-spectrum antibiotics, which is currently common practice. This has the advantage of not contributing to the problem of increasing antibiotic resistance that is a problem worldwide.

[0089] While the above description includes the preferred embodiments of the invention, it is to be understood that many variations, alterations, modifications and/or additions may be introduced into the constructions and arrangements of parts previously described without departing from the essential features or the spirit or ambit of the invention.

[0090] It will be also understood that where the word “comprise”, and variations such as “comprises” and “comprising”, are used in this specification, unless the context requires otherwise such use is intended to imply the inclusion of a stated feature or features but is not to be taken as excluding the presence of other feature or features.

[0091] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that such prior art forms part of the common general knowledge.

Claims

1. A urine capture device adapted to be held directly against the abdomen of a person using the device and capture any urine emanating from the person, said device including a first-pass flow chamber, a mid-stream chamber and an overflow chamber and a conduit that is adapted to permit urine to flow sequentially from chamber to chamber wherein the first -pass flow chamber is adapted to only hold at least 2mls of the initial flow of urine emanating from the wearer, and then once the first-pass flow chamber has reached capacity, additional flow of urine emanating from the wearer is then directed to flow via the conduit into the mid-stream chamber, and wherein the mid-stream chamber is adapted to separately contain a urine sample sized portion of the additional flow, and wherein once the mid-stream chamber is at capacity, any additional flow of urine is then directed via the conduit into the overflow chamber.

2. The urine capture device as defined in claim 1 wherein the urine captured in the mid stream chamber is isolated from any other urine contained within the device and the environment within the mid-stream chamber is substantially hygienic and protected from external contamination.

3. The urine capture device as defined in claim 1 wherein the first-pass flow chamber includes sealing means that seals the first-pass flow chamber once it has reached capacity so that subsequent flow of urine bypasses the first-pass flow chamber and flows directly into the mid-stream chamber.

4. The urine capture device as defined in claim 1 wherein the mid-stream chamber includes sealing means that seals the mid-stream chamber once it has reached capacity, so that subsequent flow of urine bypasses the second chamber and flows directly into the overflow chamber.

5. The urine capture device as defined in either claim 3 or 4 wherein the sealing means is adapted to react to contact with urine.

6. The urine capture device as defined in claim 5 wherein the sealing means includes expanding material that swells when in contact with urine and wherein the sealing means in the first-pass flow chamber is adapted to seal the first-pass flow chamber at a faster rate than the sealing means in the mid-stream chamber is adapted to close once the mid-stream chamber reaches capacity.

7. The urine capture device as defined in claim 4 wherein the mid-stream chamber includes sample extraction means that enable a health care professional to extract at least a portion of the mid-stream urine sample contained within the mid-stream chamber.

8. The urine capture device as defined in claim 7 wherein the mid-stream chamber includes a mid-stream chamber outlet, and wherein the mid-stream chamber outlet is connected to a urine extraction tube that extends out from the device and wherein the distal end of the sampling tube includes closure means that are both airtight and watertight.

9. The urine capture device as defined in claim 8 wherein the closure means are adapted to interengage with a urine extraction tool, and said tool is adapted to hygienically connect to the closure means and allow the extraction of at least a portion of the mid-stream urine stored within the mid-stream chamber.

10. The urine capture device as defined in any preceding claim including a litmus indicator strip that is visible to a health care professional and wherein said strip is adapted to indicate the presence of urine, and it is also adapted to provide a basic indication of any one or more of the following indicators:

• the presence of an infection, and/or

• the presence of white bloods cells, red blood cells and/or nitrites, and/or

• to indicate a minimum volume of 5ml of urine in the mid-stream chamber.

11. The urine capture device as defined in any one of claims 1 to 9 including a faeces barrier that is adapted to keep any faecal matter in a separate area of the device from the urine area.

12. The urine capture device as defined in claim 11 wherein counter means are included that are adapted to record the frequency of urination of the wearer while they are wearing the device.

13. The urine capture device as defined in claim 12 wherein the counter means includes a visual display that is visible from the exterior of the continence pad while the pad is being worn, and the counter means is adapted to count every distinct separate occasion that urine passes out of the external urethral opening of the wearer, thereby providing a reliable number of separate instances of urination that are then displayed as a number on the visual display.

14. The urine capture device as defined in claim 13 including logic control and memory means that are adapted to record and store the time and date of each urination of the wearer while the device is being worn.

15. The urine capture device as defined in claim 14 wherein sensor means are included that are adapted to engage with the urine contained within the mid-stream chamber and sense qualitative and/or quantitative data and send that data back to the logic control and memory means for analysis to determine if an infection is present.

16. The urine capture device as defined in claim 15 wherein the logic control and memory means are adapted to analyse the type(s) of bacteria detected in the urine and compare that bacteria type against a database of commonly used antibiotics to determine the most effective antibiotic to affect the determined bacteria type.

17. The urine capture device as defined in claim 14 wherein an electrode is included that is adapted to sense the frequency and intensity of the electrical activity of the muscle wall of the bladder of the wearer, and that data is passed to the logic control and memory means so that the rate and intensity of each bladder spasm can be analysed.

18. The urine capture device as defined in either claim 16 or 17 wherein wireless communication means are included that are adapted to communicate:

• urination event count, and/or

• the results of the analysis of the urine sample, and/or

• the frequency and intensity of the electrical activity of the muscle wall of the bladder of the Wearer, and/or

• volume of urine, and/or • the type of bacteria and its associated most effective antibiotic, to a program on a computer, including a hand-held device such as a tablet or smart phone wherein the display of the program on the computer provides a user or care provider with a “treat” or “do not treat” recommendation.

19. The urine capture device as defined in claim 31 wherein a hand-held device is adapted to send the data it receives via the wireless communication means to the cloud or remote computer/machine for further analysis.

20. The urine capture device as defined in claim 19 wherein the cloud or remote computers/machine is capable or using artificial intelligence and machine learning techniques to combine ancillary equipment monitoring the patient’s medical status, including cardiac, liver and renal status, in order to continuously improve its diagnostic capabilities.

21. The urine capture device as defined in any previous claim wherein the device is adapted to be included in either a pad or garment.

22. A method of obtaining a substantially sterile urine sample from a person using a urine capture device incorporated into either a pad or garment worn on the body of a person from which the urine sample will be taken, wherein said device includes a first-pass flow chamber and a mid-stream chamber connected via a conduit, said method including the following steps: a) preparing the person for the application of the pad or garment to their body by stream cleaning the area around their urethral opening, then b) applying the pad or garment to the person ensuring that the person’s urethral opening is properly orientated with respect to the urine capture device, then c) waiting for a urination event to occur, then d) extracting urine from the mid-stream chamber into a suitable sterile container for subsequent analysis of the urine sample extracted.