CATHETER PACKAGE FOR INTERMITTENT
URINARY CATHETERISATION
TECHNICAL FIELD OF THE INVENTION
This invention relates to intermittent urinary catheterisation.
BACKGROUND
People with certain medical conditions need to insert a urinary catheter several times a day. Until about 1992 the majority of urinary catheters used in the UK were uncoated pvc (polyvinyl chloride). The user applied a lubricant gel to the tip of the catheter to aid insertion, and a single catheter was typically used several times throughout the day and then discarded.
In 1994 hydrophilic coated catheters appeared on the market. These were more convenient for the user as they only needed to be dipped in water before insertion. Because the user did not have to keep a separate supply of lubricant this form of catheter was much more convenient, when away from home for example, and a supply of clean tap water was all that was required. Coated catheters were essentially single use, and they have therefore -2 -come to be widely regarded as much more hygienic that multiple use catheters. Combined with an increased awareness of the risk of antibiotic-resistant bacterial infections, and a reluctance to issue antibiotics for "minor" infections which are not life-threatening, uncoated multiple use catheters have become a thing of the past.
Despite the universal popularity of coated catheters, concern has been expressed over the cost of single use catheters. Furthermore, increasing awareness of the ecological consequences of plastic pollution have also caused some to question whether, in general, use of all single-use plastic items can be reduced.
Although in the long term there is likely to be a continuing market for hydrophilic coated catheters, e.g. for use when traveling, the issue of multiple use catheters has started to be re-visited with the objective of enabling multiple usage in a way which is both hygienic and acceptable to the user. One solution is proposed in WO 2017 001 830 Al. An intermittent urinary catheterisation package includes a catheter in a sealed envelope of flexible liquid impermeable material which provides a sterile environment for the catheter prior to use. The envelope has means to form an opening at one end through which the catheter is removed upon first use, allowing the envelope to be retained for re-use. The envelope also contains a pouch providing a sealed rupturable container holding a liquid antimicrobial sterilising medium. Upon rupturing the pouch, the liquid is transferred into the envelope to -3 -enable the used catheter to be immersed in the sterilising medium to prepare the catheter for re-use. The liquid antimicrobial sterilising medium is an aqueous chlorine solution. Although for many people this earlier cleaning method is simple and effective, the need to re-insert the catheter and manipulate it within the envelope to achieve effective sterilising is not ideal for some user groups, particularly disabled, frail or older users.
An aim of the present invention is to produce a cleaning method that is suitable for all users, including the frail and elderly, offering the possibility of re-use in a simple, straightforward but safe way.
SUMMARY OF THE INVENTION
When viewed from one aspect the present invention proposes a catheter package for intermittent urinary catheterisation: - a container (1) having at least one re-closable opening (2); - a plural number of catheters (10) each contained within a respective sealed envelope (14) of flexible liquid-impermeable material; - a plural number of pouches (21) each providing a sealed envelope which contains a sheet (20) of absorbent material impregnated with a liquid antimicrobial sterilising medium; wherein the catheters (10) and pouches (21) are supplied in the container (1) , and wherein the number of pouches is at least equal to the number of catheters. -4 -
The invention also provides a method of intermittent urinary catheterisation: - removing a catheter (10) from a container (1) having at least one re-closable opening (2); - removing the catheter from a sealed envelope (14) of flexible liquid-impermeable material; - using the catheter for intermittent urinary catheterisation; - returning the catheter (10) to its envelope (14) for later re-use; - removing the catheter from the envelope; - removing from the container (1) a sealed envelope (21) containing a sheet of absorbent material (20) impregnated with a liquid antimicrobial sterilising medium; - removing the sheet of absorbent material (20) from its envelope (21); - wiping the catheter (10) with the sheet of absorbent material (20); and re-using the catheter (10) for intermittent urinary catheterisation.
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 catheter package for -5 -intermittent urinary catheterisation; Figure 2 is an end view of a second form of container for use in such a catheter package.
DETAILED DESCRIPTION OF THE DRAWINGS
Referring firstly to Fig. 1, a catheter package for intermittent urinary catheterisation includes an outer container 1 in the form of a cardboard box of elongate shape. In the illustrated embodiment the container has a top opening 2 with a re-closable hinged lid 3 so that the box can securely hold the contents whilst providing easy access, e.g. for frail or elderly users. It will be appreciated however that other suitable kinds of container may be used such as rigid plastic containers with removable lids or re-closable zip-type bags.
The interior of the container 1 is divided into two compartments, 4 and 5, by a longitudinal dividing wall 6. The container 1 as supplied to the user contains a number of intermittent urinary catheters 10 which are held within the compartment 4, together with a greater quantity of wipes 20 which are held within the compartment 5.
The catheters 10 each comprise a flexible shaft 11 of pvc or similar plastic tubing, and may have a rounded tip 12 at the insertion end and a connector 13 at the opposite end. Each catheter 10, as -6 -supplied, is contained within an individual sealed envelope 14 of flexible liquid impermeable material which provides an enclosed sterile environment for the catheter prior to use. The envelopes 14 may be releasably joined together as shown, e.g. by lines of perforations, so that one envelope can be separated from the others prior to use. In another embodiment the catheters 10 may be contained within separate envelopes 14.
The wipes 20 are sheets of liquid-absorbent material which are individually packaged in separate pouches 21. As supplied, the wipes are each folded and sealed within a respective pouch 21, which is formed of flexible liquid-impermeable material. Each wipe is impregnated with a liquid antimicrobial sterilising medium. The pouches 21 thus prevent the sterilising medium from leaking out or evaporating, and ensures that the wipes remain impregnated with the liquid until used.
The purpose of the wipes 20 is to enable a single catheter to be re-used at least once without risk of infection. Upon first use the catheter 10 is removed from the sterile envelope 14 and used as normal. Once it has been used the catheter may be placed back into the envelope and retained for later use. Before a used catheter is re-inserted into the urethra it is removed from the envelope and wiped clean with one of the antimicrobial impregnated wipes 20, the pouch 21 having been cut or torn open to enable the impregnated wipe to be removed.
The package will normally carry instructions to the user, including -7 -a recommendation that each catheter should be used for no more than one day and then discarded. On average, most users of intermittent urinary catheterisation will insert a catheter about five or six times a day, so that a typical package will contain about 30 catheters and 150 wipes, providing sufficient catheters for about one month. Contrasted with single use hydrophilic coated catheters this represents a significant saving in the cost of catheterisation, and a significant reduction in plastic usage. However, even a single re-use of a catheter represents a considerable improvement. Therefore, the number of pouches Np supplied in a package is preferably at least equal to the number of catheters Nc, and is ideally at least twice the number of catheters. To encourage the use of one catheter per day the number of pouches Nc should be between four and seven times the number of catheters Nc.
The catheters 10 are of the so-called uncoated type, without any hydrophilic lubricating coating. In one embodiment the wipes 20 may be impregnated with a liquid sterilising medium that also has lubricating properties. In another embodiment the package may contain a suitable lubricating medium, which in the drawing is represented by a tube 30 of lubricant with a screw cap, but often the user will supply their own lubricant. Suitable lubricants are readily available, e.g. in sealed pouches containing sufficient lubricant for one catheterisation, syringes of lubricant, etc. In one example the liquid antimicrobial sterilising medium used to impregnate the wipes may comprises an aqueous non-ionic -8 -chlorine solution. For example, 195 mg sodium dichloroisocyanurate dissolved in 1250 ml water will provide a suitable and effective chlorine solution with good antimicrobial properties. Another suitable chlorine solution can be obtained by dissolving 30 ml of sodium hypochlorite solution with a concentration of 2% wt/vol (equivalent to weak household bleach) in 5 litres of water.
In another example a suitable liquid antimicrobial sterilising medium comprises benzalkonium chloride, didecyl dimethyl ammonium chloride, poly hexamine biguanide hydrochloride, bronopol and p-chloro-m-cresol, and optionally an alkylene glycol. Detailed laboratory investigations have demonstrated good antimicrobial efficacy of such a product, which is available under the trade designation SQ53, when applied to catheters as an impregnated wipe.
Fig. 2 shows a modified form of the container 1 which is also a cardboard box of elongate shape. The interior of the container is again divided into two compartments, 4 and 5, by a longitudinal dividing wall 6, but in this case the compartments 4 and 5 are accessed via separate openings 2a and 2b each provided with a respective re-closable hinged lid 3a and 3b. As supplied to the user, the intermittent urinary catheters 10 are held within the compartment 4 and the wipes 20 are held within the compartment 5. Again, the catheters are each contained within an individual sealed envelope of flexible liquid impermeable material and the wipes 20 are individually packaged in separate pouches 21 of -9 -flexible liquid-impermeable material, as described above. Such a container might be preferred by some people since it enables the catheters 10 and wipes 20 to be separately removed from a box which is located in a stack of similar containers, or when the top of the box is inaccessible for some other reason.
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.