AND METHOD OF USE

TECHNICAL FIELD OF THE INVENTION

This invention relates to an intermittent urinary catheterisation package and its method of use.

BACKGROUND

Intermittent urinary catheterisation 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. The vast majority of procedures are performed as self-catheterisation. Traditionally a lubricant may be applied to the catheter to reduce the risk of damage to the urethral wall, but in recent years catheters have become available which are provided with a low friction coating which requires activation prior to use by application of an aqueous medium such as sterilized water or tap water. Numerous packages have been devised with the aim of making it easier and more convenient for the user to activate the coating prior to use. DE 3900702 CI and US 2005/070882 Al disclose known packages which contain a pouch of wetting medium.

Urinary tract infections are common in people that undergo intermittent catheterisation, with most regular users experiencing at least one infection per year. Although it is not unknown to sterilise an intermittent catheter upon first use, see US 2006/263404 Al for example, many sterilising liquids are hazardous or have a limited shelf life, and catheters are generally manufactured under sterile conditions and supplied in a sterile package.

WO 2005/092418 Al discloses an intermittent self-administration catheter incorporating a collapsible sleeve which can be pushed along the catheter towards the distal end in use. By extending the sleeve over the catheter the sleeve may be used to contain a disinfection fluid in which to bathe the catheter.

Medical practitioners working in controlled environments frequently sterilise and re-use medical instruments. For example, US 2015 0068939 Al describes a multifunctional enclosure system for transporting and sterilising medical probes such as endoscopes. CN 202699302 U discloses an anaesthetic instrument bag for epidural anaesthesia which holds a sterilising liquid . US 6436085 Bl describes a suction catheter system that allows medical practitioners to re-use a suction catheter by placing the catheter in a transparent pouch containing an irrigating solution. Although medical practitioners may sterilise and re-use catheters under controlled conditions, for non-professional users in non-sterile environments health professionals currently recommend that the catheter should be used once only and then discarded.

The cost of providing intermittent urinary catheterisation for users that require it is considerable. The present invention seeks to address the problem of providing an intermittent urinary catheterisation package which is safe and convenient to use and has a low risk of urinary tract infections whilst significantly reducing costs.

SUMMARY OF THE INVENTION

The present invention proposes a method of using an intermittent urinary catheterisation package which includes:

- providing a catheter in a sealed envelope closely surrounding the catheter, the envelope being formed of flexible liquid impermeable material creating a sterile environment for the catheter prior to use, and the envelope having means to form an opening at one end thereof;

- providing a pouch formed of flexible liquid-impermeable material creating a sealed rupturable container holding a liquid antimicrobial sterilising medium;

- upon first use of the catheter, forming an opening at said one end thereof, removing the catheter through said opening, and retaining the envelope for re-use; and - prior to second use of the catheter, preparing the catheter for re-use by rupturing the pouch, transferring the liquid antimicrobial sterilising medium into the envelope, and re-inserting the used catheter into the envelope to be immersed in the liquid antimicrobial sterilising medium, in which the liquid antimicrobial sterilising medium comprises an aqueous chlorine solution.

The invention also provides a method of using an intermittent urinary catheterisation package which includes an envelope provided with an adhesive tab adjacent to means to form an opening and the envelope is suspended by the adhesive tab when preparing the catheter for re-use.

The invention also provides an intermittent urinary catheterisation package which includes:

- a catheter;

- a sealed envelope closely surrounding the catheter, the envelope being formed of flexible liquid impermeable material which provides a sterile environment for the catheter prior to use, and the envelope having means to form an opening at one end thereof through which the catheter is removed upon first use allowing the envelope to be retained for re-use; and

- a pouch formed of flexible liquid-impermeable material providing a sealed rupturable container holding a liquid antimicrobial sterilising medium which, upon rupturing the pouch, is transferred into the envelope to enable the used catheter to be immersed in the liquid antimicrobial sterilising medium to prepare the catheter for re-use, in which the liquid antimicrobial sterilising medium comprises an aqueous chlorine solution.

The invention also provides an intermittent urinary catheterisation package which includes a sealed pouch of flexible liquid-impermeable material which holds an aqueous chlorine solution.

The invention also provides an intermittent urinary catheterisation package which includes a sealed pouch of flexible liquid-impermeable material holding a dichloroisocyanurate solution.

The invention also provides an intermittent urinary catheterisation package which includes a sealed pouch of flexible liquid-impermeable material holding a hypochlorite solution.

The invention also provides an intermittent urinary catheterisation package which includes a sealed pouch of flexible liquid-impermeable material holding an aqueous chlorine solution with a concentration of from 0.05 to 0.5 % wt/vol.

The invention also provides an intermittent urinary catheterisation package which includes an envelope provided with an adhesive tab adjacent to means to form an opening.

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 an intermittent urinary catheterisation package in accordance with the invention;

Figure 2 is a front plan view of the package showing the internal contents thereof;

Figure 3 is a rear plan view of the package showing a top end detail; and

Figure 4 is a front plan view of the package showing a modified top end detail.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring firstly to Fig. 1, a package 1 includes an elongate protective outer envelope which contains a urinary catheter intended for intermittent self-catheterisation of the bladder of a user. The envelope is formed from front and rear sheets 2 and 3 of flexible liquid impermeable material which provides a sterile environment for the catheter prior to use. The rear sheet 3 may be formed of an opaque liquid-impermeable paper which can be printed with instructions and other identification material, and the front sheet 3 may be of transparent plastics sheet which an be vacuum formed to closely surround the contents of the envelope. The two sheets are welded together along their side edges 4 and 5 and along the top and bottom edges 6 and 7 to form an enclosed sterile compartment. The sheets 2 and 3 from two flaps 8 and 9 at one end of the envelope by which the sheets can be peeled apart to open the package, breaking the top end seal 6.

Referring to Fig. 2, the envelope 2, 3 contains a urinary catheter 10 and a pouch 20, both of which are enclosed by the envelope 2, 3. The catheter 10 has a catheter tube 11 dimensioned for introduction through the urethra, with a distal end provided with one or more urine inlet openings 12 and an opposite proximal end provided with an outlet connector 13 by which the catheter may be joined to a flexible pipe for conducting urine withdrawn from the bladder to a urine collection bag (not shown).

The package is manufactured under sterile conditions so that the catheter 10 is protected by the outer envelope 2, 3 against contamination by dirt or bacteria.

As shown in Fig. 3, adjacent to the top weld 6 the rear sheet 3 is provided with a patch 30 of contact adhesive which is protected prior to use by a peelable backing 31.

Returning to Fig. 2, the pouch 20 is located alongside the catheter tube 12 and is formed of flexible liquid-impermeable material such as a metal foil or metallised plastic sheet. In this example the pouch is of tubular configuration with both ends sealed by cross-welds 21 and 22. One of the welds 21 is preferably strong while the other weld 22 is relatively weak (e.g. of narrower width) which can easily be ruptured by applying squeezing pressure to the walls of the pouch. The pouch 20 provides a sealed rupturable container which holds a liquid sterilizing medium.

The antimicrobial sterilising medium contained within the pouch 20 is an aqueous chlorine solution, which is stable in storage and non-hazardous. Tests have confirmed that as a sterilising medium this solution is at least as effective as other potentially hazardous aqueous media such as hydrogen peroxide. The aqueous chlorine solution may be obtained from several different compounds, two examples of which follow:

EXAMPLE 1

195 mg sodium dichloroisocyanurate was dissolved in 1250 ml water, corresponding to a concentration of 156 mg/litre or 0.0156 % wt/vol (grams per 100 ml). A used urinary catheter was immersed in the solution for 30 seconds. Tests showed no bacterial contamination of the catheter.

EXAMPLE 2

30 ml of sodium hypochlorite solution with a concentration of 2% wt/vol (equivalent to weak household bleach) was dissolved in 5 litres of water. This corresponds to a final concentration of 0.6g in 5,000 ml or 0.012% wt/vol (grams per 100 ml). A used urinary catheter was immersed in the solution for 30 seconds. Subsequent tests showed no bacterial contamination of the catheter.

Upon first use of the catheter, the envelope is opened by peeling apart the tabs 8 and 9 to break the top seal 6 thereby forming an opening at the top end of the envelope. The catheter is then withdrawn through the top opening and used to perform catheterisation of the bladder through the urethra in the usual way. Many users are happy to perform this procedure without lubrication, but if desired the catheter may be pre-wetted or lubricated according to the user's preference.

When the catheter is withdrawn from the urethra it would normally be discarded to reduce the risk of infection. However, the package allows the catheter to be safely re-used at least once without increased risk. This is achieved by rupturing the pouch 20 to transfer the antimicrobial sterilising medium onto the envelope 2, 3. One option is to retain the pouch within the envelope and squeeze the pouch through the wall of the envelope, and another option would be to remove the pouch and squeeze the pouch externally with the rupturable end inserted into the open end of the envelope. The catheter may then be re-inserted into the envelope, distal end first, to immerse the catheter tube 11 in the antimicrobial sterilising liquid until the catheter is required for another intermittent catheterisation procedure. To reduce the risk of spillage the envelope can be suspended with the top end upmost by removing the peelable backing 31 from the patch 30 and using the adhesive patch to attach the envelope to a convenient surface.

Case studies have shown that use of the intermittent catheterisation package does not increase the risk of urinary tract infection as compared with conventional single use catheters.

In the modified embodiment of Fig. 4 the tabs 8 and 9 are replaced by a notch or notches 40, 41 in the side edge or edges of the envelope beneath the top seal 6. The or each notch forms a weak point at which the top portion of the envelope can be torn off to open the package.

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.