GB2442282A

GB2442282A - Midstream urine sample collector

Info

Publication number: GB2442282A
Application number: GB0619356A
Authority: GB
Inventors: Vincent John Charles Forte; David Edward Maddison
Original assignee: Funnelly Enough Ltd
Current assignee: Funnelly Enough Ltd
Priority date: 2006-09-30
Filing date: 2006-09-30
Publication date: 2008-04-02
Also published as: GB0619356D0

Abstract

A urine collection device 1 comprises a collection means 2, an outlet means 3 and a transfer aperture 4. The outlet means 3 is a hollow tubular member mounted within the collection means 2 and has a lower end 5 forming an outlet from the device 1 and an upper end 6 forming an overflow aperture. A drainage aperture 7 is formed in the tubular member at the lower end 5. In use, urine collected by the collection means 2 first drains through the drainage aperture 7 at a first rate, then is transferred to a sample bottle 8 through the transfer aperture 4 and when the sample bottle 8 is full drains from the device via the overflow aperture 6 at a second, higher rate. This provides a midstream sample in the sample bottle 8. The device may be made from waxed paper or biodegradable polymeric material.

Description

URINE COLLECTION DEVICE

This invention relates to a device to assist in the collection of urine from a patient.

The analysis of a patient's urine is often used as a diagnostic method for detecting a wide range of conditions and illnesses. The urine can be analysed for particular chemicals that are indicative of particular infections, for example. Analysis of a mid stream urine sample is preferred for accurate results, as it is thought to be more representative of the state of the urine. As its name implies, a mid stream sample should not contain urine from the initial flow.

The patient is typically required to provide a urine sample into a sample bottle. In general, sample bottles are relatively small and have a narrow neck, making it difficult for the patient to accurately deliver a sample into the bottle. Due to these difficulties, providing a urine sample can be a messy and unpleasant process especially if a mid stream sample is required. The difficulties are particularly acute when the patient is female, due to the problem of locating the sample bottle correctly.

Prior art devices have been made to assist patients in delivering a sample.

EP 1 401 334 discloses a device having a collection funnel that automatically expands from its flat-packed storage configuration into a usable configuration, thereby making locating the device appropriately easier. The device has an outlet to which a sample bottle can be placed for easier collection. However, this device does not address the issue of ensuring the effective filling of a sample bottle, while ensuring the collection funnel does not overflow. It does not make provision for taking a mid stream sample, either.

Further, GB 2 385 532 discloses a urine sample collection device that is adapted to collect a mid stream urine sample. The device has means to divert the initial flow of urine away from an aperture to which a sample bottle is connected. As the urine flow increases, urine enters the aperture. As this device depends on the urine flow rate it may be unreliable at collecting a mid stream sample.

According to the present invention we provide a urine collection device comprising; a collection means to collect urine voided by the user; an outlet means adapted to allow urine collected by the collection means to drain from the device; a transfer aperture adapted to allow urine collected by the collection means to be transferred to a receptacle; a drainage aperture connected to said outlet means adapted to allow urine collected by the collection means to drain at a first rate; and an overflow aperture connected to said outlet means and adapted to allow urine collected by the collection means to drain at a second, higher, rate.

The provision of a drainage aperture and an overflow aperture ensures that a sample is effectively collected and that the device is easy and hygienic to use. The drainage aperture allows the urine initially voided by the patient to drain away, meaning that urine voided mid-flow will be transferred to the receptacle, which is advantageous for analytical purposes. Further, the provision of a further overflow aperture ensures that the flow rate out of the device is sufficient to prevent it overflowing.

Preferably the size of the drainage aperture determines the first rate at which urine drains from the device. Preferably the size of the overflow aperture determines the second rate at which urine drains from the device.

The size of the overflow aperture in combination with the size of the drainage aperture may determine the second rate at which urine drains from the device.

The drainage aperture and the overflow aperture may be of the same size and thus achieve in combination the second, higher, rate of flow through the outlet means. However, preferably, the overflow aperture is larger than the drainage aperture. Thus, the overflow aperture and the outlet means are sized to prevent the collection means overflowing as they are adapted to ensure urine leaves the device at a sufficient rate.

Preferably, the drainage aperture is located in the collection means such that all of the urine collected by the collection means can drain out of the device. Preferably the drainage aperture is U-shaped, but it may be circular or of any other appropriate shape. For example, the drainage aperture may comprise a slot formed in the end of the outlet means. The drainage aperture may also be formed by a gap between the collection means and the outlet means. Preferably, the gap is formed by spacing members that project from the outlet means and to which the collection means is secured.

Preferably the transfer aperture is formed in a connecting port in the collection means. Preferably the port has connection means to receive a sample bottle. The connection means may be a connecting collar adapted to receive and retain a sample bottle by interference fit. Alternatively, the connecting port may have a screw thread to retain the sample bottle.

The connecting port may be formed integrally with the collection means, although it may be affixed to the collection means.

Preferably, the device is constructed and arranged such that, in use, the sample bottle is held at an angle from its upright position. Thus, when the patient has finished using the device and the bottle is returned to its upright orientation, the sample bottle is not full to its brim. The risk of spillage when the sample bottle is removed from the connecting port is therefore reduced allowing a cap to be placed on the bottle without tainting the patient's hands. The device is therefore hygienic.

Preferably the collection means comprises a funnel shaped member having a larger and a narrower end, wherein the larger end forms a receiving end for positioning adjacent the patient when in use. Preferably the outlet means is located adjacent the narrower end. The outlet means may comprise a tubular member in which at least the drainage and overflow apertures are formed.

Preferably, the drainage aperture is located at a lowermost point in the collection means, the transfer aperture is located at a higher point in the collection means and the overflow aperture is located at a still higher point in the collection means. This arrangement of apertures ensures that as the collection means fills with urine, it first passes out of the drainage aperture. The drainage aperture is sized such that the level of the urine collecting in the collection means rises and under normal circumstances will continue to rise so that it reaches the transfer aperture and fills the sample bottle. If the rate of flow into the device is sufficiently high or when the sample bottle is full, the level will rise up to the overflow aperture. The overflow aperture is sized so that urine can leave the device by the outlet means at a rate sufficient to prevent the level of the urine in the collection means rising further. The overflow means thus prevents the device overflowing even when a large volume of urine is collected by the device and also when the rate of flow is high.

The device is particularly advantageous as the overflow aperture, drainage aperture and the transfer aperture are positioned to ensure the urine collected is mid stream urine.

The device is a single-use device, and for ease of use will normally be disposed of in a toilet. It must therefore be readily flushable and biodegradable. The material or materials used must be able to withstand the temperature of urine for a short time, so that the device keeps its shape in use, but then readily soften in water, to enable it to be flushed away. The device could be made of paper, in particular waxed paper, or a biodegradable polymer such as Plantic (RTM). It is also imperative that the material has no physico-chemical effect on the urine, either by contaminating it or absorption from it. The material may therefore be coated with a suitable inert substance.

Preferably the device is constructed and arranged such that it can be stored flat. Preferably the device includes automatic opening means that opens the collection means from the flat storage configuration to an open configuration in which it can receive urine.

There now follows by way of example only a detailed description of the present invention with reference to the accompanying drawings in which; Figure 1 shows a side view of the device of the invention; Figure 2 shows a top view of the device shown in Figure 1; Figure 3 shows a front view of the device shown in Figure 1; Figure 4 shows a further embodiment of the drainage aperture; and Figure 5 shows a still further embodiment of the drainage aperture.

The urine collection device 1, as shown in the drawings, comprises a collection means 2 formed as a funnel, an outlet means 3 and a transfer aperture 4. The outlet means 3 comprises a hollow tubular member mounted within the collection means 2 and wherein a first lower end forms an exit 5 from the device 1 and a second upper end forms an overflow aperture 6. A drainage aperture 7 is formed in the tubular member 3, at a position within the collection means 2 and adjacent the exit 5.

The tubular member 3 is sealingly connected to the lower end of the collection means 2, and is held adjacent its upper end by a connecting port 10, which defines the transfer aperture 4. The port 10 and includes a screw thread 11 on its internal annular face to engage with a complementary thread 12 on a neck 13 of the sample bottle 8. The threads 11, 12 are preferably adapted to fully engage after a quarter turn and at least after a half turn. This makes connecting the bottle 8 easy.

The connecting port 10 has the tubular outlet means 3 passing therethrough. This is shown more clearly in Figure 3. Thus, fluid entering the transfer aperture 4 flows around the sides of the tubular outlet means 3 and through connecting port 10 into the sample bottle 8.

The connecting port 10 is affixed to the collection means 2 by adhesive.

However, it will be appreciated that the connecting port and the collection means may be joined by any appropriate method, including being formed integrally or being welded together.

The collection means 2 comprises a funnel shaped member of flexible polymeric or paper material. However, although the funnel is flexible, it has sufficient rigidity to substantially maintain its shape when it is in use and contains urine. It may be of a polymeric material chosen to have the necessary degree of rigidity or alternatively it may have support ribs or reinforcing elements at predetermined locations. The polymeric material may be of a type that prevents liquid droplets forming on its surface to encourage urine collected in the funnel 2 to drain towards the drainage aperture 7. Alternatively, the collection means 2 may be coated in or treated with such a material. The funnel 2 has a larger end 14 and a narrower end 15. The narrower end 15 is affixed to the external surface of the outlet means 3, adjacent the exit 5, again by welding or any appropriate means. The larger end 14 includes a rim 16. The rim 16 is ergonomically shaped to fit comfortably against or adjacent to the patient's body while ensuring minimal spillage. Further, the rim 16 is formed at an angle such that when the device is in use and position adjacent the patient's body, the sample bottle 8 is at an angle to its upright position. This ensures that when the device 1 is in use, the sample bottle 8 will not fill to the brim thereby making it easier to handle when removing it from the connecting port 10.

The tubular member 3 is also of polymeric or paper material. The drainage aperture 7 is U-shaped and formed in the wall of the tubular outlet means 3. The position of the drainage aperture 7 means that when the device 1 is in use, the aperture 7 is at the lowest point, enabling substantially all of the urine collected by the collection means 2 to drain away. Therefore the patient is not required to empty the device in any way when they have finished using the device, as the collection means 2 will empty in normal operation by virtue of the position of the drainage aperture 7. This feature further improves the hygiene for the patient when using the device 1.

The overflow aperture 6 is the uppermost aperture followed by the transfer aperture and then the drainage aperture. The overflow aperture 6, and thus the outlet means 3, has a larger cross-sectional area than the area of the drainage aperture 7 and therefore will allow a higher flow rate out of the collection means 2. Thus, the second flow rate is determined by a combination of the size of the drainage aperture 7 and the overflow aperture 6, and ultimately by the size of the outlet means 3.

Typically, the drainage aperture 7 is able to effectively drain urine from the device when the input rate is between 5 and lOmlIs. The overflow aperture 6 is able to effectively drain urine from the device when the input rate is at least 50m1/s. As the normal urine flow rate of a person is between 10 and 4Oml/s, the device allows the drainage of the initial flow of urine (approximately the first 10-20m1) to obtain a mid-stream sample and the overflow aperture will be able to drain urine at a sufficient rate to ensure the device does not overflow.

In use, a patient removes the device 1 from its packaging and allows it to automatically open from its flat storage configuration into the open configuration by way of automatic opening means that bias the device such. The patient then attaches the sample bottle 8 to the connecting port 10 by the screw threaded portions 12,13. The patient can then position the device 1 appropriately with the rim 16 adjacent to or in contact with the patient's body, while holding the sample bottle 8. The patient can then begin voiding urine into the collection means 2.

The urine will begin to collect in the collection means 2 and flow to the narrow end 15, where it will drain through drainage aperture 7. The drainage aperture 7 is sized such that with a typical flow rate into the collection means 2, urine will not leave the device 1 faster than it enters.

Thus, the collection means 2 will begin to fill. As the level rises to adjacent to the transfer aperture 4, the urine will flow from the collection means 2, through the transfer aperture 4 and into the sample bottle 8. As the level is required to rise before any urine enters the sample bottle 8, the sample is obtained from urine voided mid-flow, which is advantageous for analytical purposes. If the level of urine in the collection means 2 continues to rise, it will enter the overflow aperture 6. Urine entering the overflow aperture is directed along the tubular outlet means 3 and out of the device. The size of the overflow aperture 6 is chosen such that the urine level will not rise any further. When the patient has finished urinating, the level will begin to fall as the urine in the collection means 2 drains through drainage aperture 7. Due to the position of aperture 7, the collection means 2 will be substantially empty of urine once draining is complete. Due to the angle at which the sample bottle 8 is held when the device 1 is in use, it will be filled as represented by the dashed line 17, which represents the urine level. The device 1 can then be orientated so that the, sample bottle 8 is upright. It can then be removed by unscrewing it from the connection port 10. Typically a cap (not shown) is placed on the sample bottle 8 to seal it and then sample can then be handed to a physician, for example. The device 1 can then be disposed of.

The features of the present invention ensure that the device is hygienic and very easy to use. The patient can urinate as normal and the combination of apertures and outlet means ensure that the flow is controlled such that a sample is effectively collected without overflowing.

Further, the patient is not required to interrupt the flow to ensure an appropriate amount is collected.

The material chosen for the device 1 should be biodegradable and flushable, in other words it can be flushed away in a toilet, for example, after use. Any polymeric material must therefore be of a grade that softens in water, but is sufficiently strong that the integrity of the device is not compromised for the duration that urine could be expected to flow through the device. Thus, a material that can resist warm urine for 1 to 2 minutes before losing its integrity is preferable. Alternatively, the internal surface of the device may have a wax coating to prevent premature softening of the material of the device. Alternatively, the material may be a composite of high and low temperature resistant grades of polymeric material. Plantic (RTM), which is a polymer made from plant material, is suitable, as is paper, in particular waxed paper. If needed, the device 1 may have a protective coating (not shown) at least on its surfaces that would be in contact with any urine in normal use.

The protective coating ensures that the urine sample being collected does not absorb any chemicals from the material of the device or vice versa, as that could affect the results of any subsequent medical analysis.

The device 1 also has automatic opening means (not shown). The collection means 2 is flexible such that the device 1 can be stored in a substantially flat configuration. Once removed from any packaging, for example, the automatic opening means bias the collection means 2 into an open configuration. In the open configuration the collection means 2 adopts its funnel-like appearance and is thus prepared for receiving urine.

The device may be self-opening, if the material is such that it provides the necessary resilience. Alternatively, a separate resilient means may be used to open the device and the device may have hinged portions as necessary.

Figure 4 shows an alternative configuration for the drainage aperture 7 and is designated 7'. The drainage aperture 7' is formed in the wall of the tubular outlet means 3 as before. However, in this embodiment it comprises a slot 20 having a curved edge 21 formed at the exit 5 of the outlet means 3. The funnel shaped collection means 2 is attached to the outlet means 3 adjacent the exit 5 and thus bridges the gap formed by the slot 20 as represented by dashed line 22.

Figure 5 shows an end view along the outlet means 3 from the exit 5 of the device 1. In this embodiment, the drainage aperture 7, 7' is not formed as an aperture in the wall of the outlet means 3. The collection means 2 is not affixed directly to the outlet means 3 adjacent the exit 5, but is instead spaced from the outlet means by spacers 18. Thus, the drainage aperture 7" comprises a gap formed between the collection means 2 and the outlet means 3 adjacent the exit 5. Four spacers 18 are shown projecting from the tubular outlet means 3 and are formed integrally therewith. The collection means 2 is attached to the spacers 18 by adhesive. It will be appreciated that the number of spacers 18 will be chosen depending on the rigidity of the material of the collection means 2 and accordingly its ability to maintain the gap that forms the drainage aperture 7". Further, the length of the spacers 18 (that is, the amount they project from the surface of the outlet means 3), the number of spacers 18 and the width of the spacers 18 will all affect the area of the drainage aperture 7". Thus, these parameters are chosen to result in the desired drainage flow rate out of the device 1. It will be appreciated that the spacers 18 may be individual components that are affixed to the outlet means 3. The collection means 2 may be welded to the spacers 18 instead of being secured by adhesive. Further, the collection means 2 may include a reinforcing ring (not shown) at the point where it is affixed to the spacers 18. The reinforcing ring helps to maintain the shape and, in particular, the size of the drainage aperture 7". The ring may comprise a separate component that is secured to the collection means 2.

Alternatively, it may be formed by a thickening or more resilient grade of the material forming the collection means 2 at the point where it is to be attached to the outlet means 3.

In a modification (not shown) the tubular member 3 and the connecting port 10 may be formed integrally.

Claims

1. A urine collection device comprising: a collection means to collect urine voided by a user; an outlet means adapted to allow urine collected by the collection means to drain from the device; a transfer aperture adapted to allow urine collected by the collection means to be transferred to a receptacle; a drainage aperture connected to the outlet means and adapted to allow urine collected by the collection means to drain at a first rate; and an overflow aperture connected to the outlet means and adapted to allow urine collected by the collection means to drain at a second, higher rate, the drainage aperture and overflow aperture being formed in a tubular member forming the outlet means.

2. A urine collection device as claimed in claim 1, in which the size of the drainage aperture determines the first rate at which urine drains from the device.

3. A urine collection device as claimed in claim 1 or claim 2, in which the size of the overflow aperture determines the second rate at which urine drains from the device.

4. A urine collection device as claimed in any preceding claim, in which the transfer aperture is formed in a connecting port in the collection means.

5. A urine collection device as claimed in claim 4, in which the port has means to retain a sample bottle.

6. A urine collection device as claimed in any preceding claim, in which the device is so constructed and arranged that in use the sample bottle is held at an angle to its upright position.

7. A urine collection device substantially as described herein with reference to and as illustrated in the accompanying drawings.