TECHNICAL FIELD OF THE INVENTION

This invention relates to female urine drainage devices.

BACKGROUND

Intermittent self catheterisation of the bladder via the urethra is a widely performed procedure, which may, for example, be necessitated by operative procedures or spinal cord injuries where the patient loses the ability to control their bladder.

A ubiquitous urine drainage device comprises a flexible catheter tube which is manufactured from a soft thermoplastic material such as polyvinyl chloride. Such devices are widely used by both males and females, the female version being substantially shorter. Normally the catheter tubes have one or more openings at a proximal end which is inserted through the urethra into the bladder, and a connector at the opposite distal end is used to attach a drainage tube or urine collection bag. Such catheters have many advantage such as being soft and flexible, durable, and are capable of being coated with lubricating substances which become activated when wet.

A female urinary drainage device which is integrally moulded with an integral closure and hand grip has been manufactured for about two decades. The device is described in EP 0 836 500-A1 and has won awards for its innovative features. The unique hand grip enables female patients with poor hand dexterity to insert the device into their bladder more easily, and the integral closure with a unique opening and closing mechanism enables the user to decide, in her own time, when she is ready to drain. Another notable feature is that it was the first intermittent urinary drainage device to be moulded from cornstarch. The device is reusable for up to 24 hours, and is 100% biodegradable.

Compared with male and female drainage devices comprising a flexible catheter tube, the biodegradable moulded cornstarch product is relatively inflexible, which is an important requirement to allow the opening and closing mechanism to operate. Although biodegradable, they do not readily dissolve in water so that they are normally discarded in a bin, which can be inconvenient and embarrassing for the user.

SUMMARY OF THE INVENTION

When viewed from one aspect the present invention proposes a one-piece integrally moulded female urine drainage device. The device has: - a tubular part (2) having a distal end (5) and a proximal end (4);

- an inlet opening (3) at the proximal end;

- an outlet opening (6) at the distal end;

- a hand grip (10) projecting from the tubular part;

- a closure (7) for closing the outlet opening;

- a first hinge (8) connecting the closure to the tubular part.

A distinguishing feature of the device is that it is formed of a water soluble mouldable material.

The proposed device is water soluble and can readily be flushed down a toilet while at the same time having sufficient stiffness and durability to retain the features which are much favoured by female users. Another significant feature is that the entire device can be flushed down a toilet without having to detach a non-soluble connector.

In a preferred embodiment the water soluble mouldable material is a synthetic resin, most preferably a vinyl alcohol polymer.

In a preferred embodiment the water soluble mouldable material has the chemical formula [CH2CH(OR)] _n where R = H or COCH3, with the COCH3 groups being randomly distributed throughout the molecule.

In a preferred embodiment the water soluble mouldable material has a degree of hydrolysis from 85-89%.

The female urine drainage device is preferably water soluble down to 10 degrees Celsius.

BRIEF DESCRIPTION OF THE DRAWINGS

The following description and the accompanying drawings referred to therein are included by way of non-limiting example in order to illustrate how the invention may be put into practice. In the drawings:

Figure 1 is a general view of a female urine drainage device prior to insertion into the bladder;

Figure 2 is a similar view of the female urine drainage device which is in use to drain the bladder.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring firstly to Fig. 1, the drainage device 1 has a tubular part 2 with one or more lateral inlet openings 3 at a proximal end 4. The opposite distal end 5 has a single outlet opening 6 (Fig. 2), which is disposed co-axially with the tubular part 2, and a closure 7 which is integrally joined to one edge of the outlet opening by a first hinge 8. The closure 7 is shaped to cover the opening 6 and includes an angularly-projecting extension arm 9. An integral axially-extending hand grip 10 projects from one side of the tubular part 1 adjacent to the distal end 5. A curved resilient member 11 connects the closure extension arm 9 to the hand grip 10, being connected to the extension arm 9 by a second hinge 12 and to the hand grip 10 by a third hinge 13. All three of the hinges 8, 12 and 13 are web hinges which are integrally formed with the adjacent elements.

When the drainage device is in a first stable configuration as in Fig. 1, the resilient member 11 urges the closure 7 against the outlet opening 6. As shown in the drawing, a female user can conveniently exert moderate pressure on the closure 7 by means of their index finger to ensure closure of the outlet opening whilst holding the hand grip 10 with the tubular part 1 in a comfortable position for insertion into the urethra 14. The closure 7 therefore effectively blocks the flowpath through the tubular part 1. When the tubular part has been inserted far enough for inlet opening 3 to lie within the bladder 15 as shown in Fig. 2, the user can, at her convenience, slide her index finger onto the extension arm 9 and resilient member 11. The slight increase in pressure on these parts causes the closure 7 to flip into an open position permitting urine to drain from the outlet opening 6. When drainage is complete, with slight reverse movement of the index finger the closure 7 can be flipped back to the closed position to prevent urine from dripping from the opening 6 while the tubular part 2 is withdrawn from the urethra 14.

Such drainage devices have hitherto been manufactured by injection moulding using cornstarch which, although being biodegradable, is insoluble in water. The present device is integrally moulded from a water soluble polymer so that the entire device loses its structural integrity in water and can therefore be safely flushed away into the sewerage system.

A preferred water soluble and suitably mouldable material is vinyl alcohol polymer, INS No. 1203, as manufactured by Distrupol, a Univar company. Vinyl alcohol polymer is a synthetic resin which is prepared by the polymerization of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerization and the amount of hydrolysis. Vinyl alcohol polymer has the chemical formula [CH2CH(OR)] _n where R = H or COCH3, with the COCH3 groups being randomly distributed throughout the molecule. Vinyl alcohol polymer has a wide range of uses, and is approved for use as a biomaterial in medical devices due to its proven biocompatible, nontoxic and noncarcinogenic properties. To touch and feel, the material can be as flexible as low density polyethylene (LDPE) or as rigid as polypropylene (PP). Injection mouldable grades have been developed with a melt flow rate as low as lg/10 min and as high as lOOg/10 min. On initial contact with water vinyl alcohol polymer forms a lubricating surface. On longer exposure the material dissolves to form acetic acid, which is incorporated into the natural biomass by naturally occurring microorganisms.

The solubility of vinyl alcohol polymers depends largely on their amount of hydrolysis. A polymer with a level of hydrolysis between 85 to 89% dissolves easily at room temperature, while PVA that has high hydrolysis degree (98-99%) is not soluble at room temperature. This difference in solubility is due to the hydrogen bonds between the vinyl alcohol chains which are greater when the degree of hydrolysis is high.

MonoSol of the USA produces a vinyl alcohol polymer under the trade name MonoPol which can be used to produce injection moulded products which dissolve when they contact water so that they can be dissolved away without leaving contaminated waste. The MonoPol family includes a variety of formulations which can be selected to work at different fabrication speeds and different temperatures. Moulding also allows structures to be customized by changing wall thickness and dimensional strength. MonoPol is available in four grades: cold water soluble (from about 10 degrees C) to very hot water soluble (above 70 degrees C). Each grade is available in a range of colours, and mechanical properties can be adjusted and customised for specific applications.

The female urine drainage device is particularly suitable for intermittent self catheterisation and has advantages over known devices:

- The entire product is water soluble, environmentally friendly and flushable.

- The user retains full control over urine drainage.

- The tubular part is self-lubricating on contact with water.

- The device is hypoallergenic.

Whilst the above description places emphasis on the areas which are believed to be new and addresses specific problems which have been identified, it is intended that the features disclosed herein may be used in any combination which is capable of providing a new and useful advance in the art.