GB2528466A - Flushable urinary catheter - Google Patents

Abstract

A flushable urinary catheter 1 comprising a catheter tube 1a provided at its proximal end with a catheter connector 1b, wherein at least the catheter tube 1a is formed from a polyvinyl alcohol (PVA), preferably selected from Mowiflex TC (RTM) or Mowiol (RTM) grades of PVA. The catheter 1 may further be dimensioned for male and female users, and further the distal end of the catheter 1 may be provided with drainage openings 3 of circular, oval or elliptical profile. The catheter connector 1b is preferably tapered, has ribs on its outer surface, and has engagement means on its inner surface. The catheter 1 may further comprise: plasticisers, preservatives, antimicrobials, colourants, acidity-regulators, additives to improve consistency, elasticity, processing, and resistance to dehydration. Claims are also provided for a kit comprising a catheter 1 and a urinary collection bag, and a method of manufacturing a flushable catheter.

Description

FLUSHABLE URINARY CATHETER

The present invention relates to a urinary catheter arid more specificahy to a urinary catheter whch can be hygienicafly disposed of by being safey s flushed down a toUet

Background of the Invention

Urinary catheters, particularly urinary catheters for short term use, such iD as intermttent catheterisation, are well known Typicahy, urinary catheters are made of durable thermoplastic materials, such as polyethylene, polypropylene or polyvinyl chloride. A major problem with existing catheters is that it is difficult to dispose of a used catheter in a conven ent and hygienic manner For example, the used catheter may need to be wrapped and placed in a bin or incinerated. The disposal of a catheter in this way is unhygienic, and inconvenient for a user.

Various proposals have been made for urinary catheters which can be flushed down a toilet. However, there are significant disadvantages with the products that have been developed to date. The buoyancy and lack of degradability of used urinary catheters made from certain materials makes it difficult to flush them away.

If the catheters decompose readily to allow them to be flushed away, they are oft en not strong enough to withstand use. However, if the catheters do not decompose readily they cause a pollution problem in the sewerage system and environmental damage following disposaL The urinary catheter described in patent publication US 2011/0071507 was designed in order to overcome some of the problems described above The documort describes a flushable medical device for short term use, such as a urinary catheter, comprising at east an elongate shaft made of a degradable material, the degradabihty be ng such that the material becomes essentially totafly dissolved if maintained in turbulent water for at least 6 hours, but retains its structural integrity in water for at least 5 minutes, and preferably at Least 10 minutes. The degradability properties are achieved by the use of a material comprising at least one of a monosaccharide, disaccharide, oligosaccharide and polysaccharide.

Thus, the degradable material is primarily made of water and at least one of sugar and starch, and optionally gelatin.

Unfortunately, the known products suffer from the problem of being stiff or rigid and their physical properties are difficult to manipulate to make them confortable to use and simultaneously readily disposabre by flushing to the sewer. Furthermore, starch products have not been well received by users.

Therefore, there remains a need for a flushable urinary catheter formed from a suitable degradable material that does not pose the above problems in terms of discomfort for users, difficulty in manufacture and convenient disposability by flushing away in a toilet.

The present invention sets out to provide an improved urinary catheter, which is convenient to use and overcomes the problems identified above by being suitabie to be flushed down a toilet, preferably in its entirety

Summary of the In vent/on

In one aspect, the invention provides a flushable urinary catheter comprising a catheter tube having a distal end and a proximal end, the proximal end being provided with a catheter connector, wherein at least the catheter tube is formed substantially from a polyvinyl alcohol.

It has surprisingly been found that a catheter tube made from a polyvinyl alcohol material retains its structural integrity sufficiently in order to be used for its intended purpose, but, upon immersion in a toBet bowl, the s structure of the tube is weakened to become less buoyant such that the catheter tube can be flushed away.

A fiushable catheter tube allows for convenient and hygienic disposal after use Advantageously, a user is not required to wash or wrap tne catheter tube for re-use or disposai and it can be easdy disposed of by users with limited manual dexterity.

The present inventors have found that certain grades of polyvinyl alcohol (PVA) are particularly useful in forming a urinary catheter tube that has high degradability allowing it to be flushed down a toilet following use, and that also has sufficient structural integrity to be used for the intended purpose. Particularly preferred grades of polyvinyl alcohol include Mowifiex TC ® or Mowiol ® grades of PVA commerciaHy available from Kuraray Specialtites Europe GmbH A polyvinyl alcohol selected from the group consisting of Mowiflex IC ®, Mowiol 15-79 ®, Mowiol 3-33 ®, Mowiol 488 ®, Mowiol 5-83 ®, or a combination of two or more thereof is preferred.

The polyvinyl alcohol material used to form the urinary catheter tube may comprise one or more additives to optimise the physical properties of the catheter tube. For example, the polyvinyl alcohol material may contain one or more plasticisers.

Preferably plasticisers are selected from water, di and tn glycols and glycerine trimethyl propane.

One or more addftional additives can be included. Prefered additional additives are selected from preservatives1 antimicrobials, colourants, acidity regulators, additives to improve consistency, elasticity, processing, resistance to dehydration, and surface finish.

Calcium carbonate and / or titanium dioxide are preferably added to provide a white-coloured uruiary catheter tube Advantaqeously, the catheter tube s self-iubncating when wet to Advantageously, a catheter tube that is self-lubricating allows for easier insertion and retraction of the urinary catheter.

Preferably, the urinary catheter has an overall length of at least about 90 is mm, Preferably, the urinary catheter has an overall length of up to about 600 mm. In one preferred embodiment, the urinary catheter has a length of about 90 mm to about 200 mm.

Pre'erably, the catheter tube nas a length of between about 70 mm and about 580 mm. More preferably, in one embodiment, for female users, the catheter tube has a length of about 70 mm to about 180 mm. In an alternative embodiment, for male users, the catheter tube has a length of about 280 mm to about 380 mm Preferably, the catheter tube has an outer diameter (shown as dcl on Figure 1) of between about 2 mm and about 8 mm.

Preferably, the catheter tube has an inner diameter of between about 0.5 mm and about 7.5 mm.

Preferably, the wall thickness of the catheter tube is between about 0.25 mm and about 1.5 mm. More preferably, the wall thickness of the catheter tube is about 0.75 mm.

Preferably, one or more drainage openings are provided at the distal end of the catheter tube For example, the catheter tube may define one, two, three, or four drainage openings. In one embodiment, the catheter tube defines one drainage opening. In another embodiment, the catheter tube defines two drainage openings. Such openings enable drainage of urine from the bladder of the user into the catheter tube Preferably, the drainage openings defined in the catheter tube are circular, oval or ellipticaL A catheter connector is provided to allow the user to connect the catheter is tube to a further catheter section or to a urinary collection bag or other collection device. The catheter connector is preferably tapered. The outer surface of the catheter connector preferably includes one or more ribs for ease of handling. The inner surface of the catheter connector preferably ncludes engagement means Suitable engagement means include a threaded engagement means, or an arrangement of one or more projections and/or ndentations Such an engagement means faculitates the secure connection of the urinary catheter to an inlet connector of a urinary collection bag.

In one embodiment of the present invention, the catheter connector is formed from a degradable material. Preferably, the catheter connector comprises a water soluble material Where both the catheter tube and connector are formed from a water soluble material, the urinary catheter is suitable to be flushed down a toilet in its entirety. Preferably, the catheter connector is formed from a polyvinyl alcohol material. Preferred grades of polyvinyl alcohol materials include Mowiflex TC ® or Mowiol ® grades of PVA commerciafly avaflable from Kuraray Specialtites Europe GmbH A polyvinyl alcohol selected from the group consisting of Mowflex TC ®, Mowiol 15-79 ®, Mowiol 3-83 ®, Mowiol 488 ®, Mowiol 5-88 ®, or a combinabon of two or more thereof is preferied The polyvinyl alcohol material used to form the connector may comprise one or more additives to optimise the physical properties of the connector.

For example, the polyvinyl alcohol material may contain one or more piasticisers Preferably plasticisers are selected from water, di and tn glycols and glycerine trimethyl propane.

One or more additional additives can be included. Prefered additional is additives are selected from preservatives, antimicrobials, colourants, acidity regulators, additives to improve consistency, elasticity, processing, resistance to dehydration, and surface finish.

Calcium carbonate and / or titanium dioxide are preferably added to zo provide a white-coloured connector.

In another embodiment, the catheter connector comprises a biodegradable material. The use of such materials is advantageous since they can be easily broken down by microorganisms following disposal thus minirnising their environmental impact.

According to a second aspect of the present invention, there is provided a kit comprising a urinary catheter as described above, together with a urinary collection bag. Such a kit is particularly useful for users with limited mobility since the kit may be used in any convenient location, without necessitating the transfer of the user to a seated position on a toUet.

In one embodiment of tne present invention, the urinary collection bag is formed from a degradable material. Preferably, the urinary collection bag compnses a water soluble material, allowing the bag to be flushed down a toilet in its entirety. This embodiment of the invention is particularly convenient tot a user, since the urinary catheter may be used together with the urinary coUection bag, and the entire assembly may be flushed down a toilet without the need to disassemble any parts thereof Preferably, the urinary collection bag is formed from a polyvinyl alcohol material. Preferably, the polyvinyl alcohol materials for the collection bag are not soluble at temperatures below 36°C. More preferably, the polyvinyl alcohol materials for the collection bag are not soluble at temperatures below 400C. Most preferably, the polyvinyl alcohol materials for the collection bag are not soluble at temperatures below 50°C.

Preferred grades of poyvinyl alcohol materials include Mowiflex TC ® or Mowiol ® grades of PVA commercially available from Kuraray Specialtites Europe GmbH. A polyvinyl alcohol selected from the group consisting of Mowiflex TC ®, Mowiol 15-79 ®, Mowiol 3-83 ®. Mowiol 4-88 ®, Mowiol 5-88 ®, or a combination of two or more thereof is preferred.

The polyvinyl alcohol material used to form the bag may comprise one or more additives to optimise the physical properties of the bag. For example, the polyvinyl alcohol material may contain one or more plasticisers.

Preferably plasticisers are selected from water, di and tn glycols and glycerine tn methyl rropane One or more additional additives can be included. Prefered additional additives are selected from preservatives, antimicrobials, colourants, acidity regulators, additives to improve consistency, elasticity, processing, resistance to dehydration, and surface finish.

S

Calcium carbonate and / or titanium dioxide are preferably added to provide a white-coloured bag.

Preferably, the urinary collection bag has an inlet leading to a waste collection space defined by two opposing surfaces of two walls, the opposing surfaces configured to separate on the introduction of waste through the inlet. Preferably, the inlet is defined in one oc the walls Preferably, the inlet is located adjacent to the top of the bag.

Preferably, the urinary collection bag is formed from a material that is sufficiently thin to enable the bag to be flushed down a toilet in its entirety. For example the thickness of the walls of the bag is preferably no more than about 5Opm. Preferably, the thickness of the wails of the bag no more than about 4Opm.

Any suitabie size of urinary collection bag may be included in the kit of the present invention. Preferably, the urinary coflection bag can accommodate at least 750 ml o I quid In one embodiment, the urinary collection bag comprises an inlet connector. Preferably, the outer surface of the inlet connector inciudes enyagement means Suitable engagement means include a threaded engagement means, or an arrangement of one or more projections and/or indentations Preferably, the engagement mea s are complementary w th engagement means of a catheter connector. Such an engagement means factfltates the secure ponnettjon of U.. urinary catheter connector to the intitconnector of the urinary coHection bag.

Pteferably; the lit: taanetttrof the urinar coileetion bag is formed from a øW44b!. rnmi4l. PPIW:$is the 1nc(e conrectcr øtt!pr!e. :a watE.r soluble material More preferably the mniét connector S formed lm a polyvinyl alcohol mattfiL Preferred grades of polyvihyl alcohol Indude r4owitlex it ® or Mowiol ® gradcs of WA commercially available fit Ku ayspEaltltes Ethdpe GmbH. A liñl ?alt6hbl SCJe td frbm the gyoup onS of MQvAiiflex TC ®r MowS szg®, Mowlo! Mowiol 4-88 ®, Mo*tci588 ®, or a combination öfl*: or more thereof is preferret kccøfr to a third aspect of *e pr4sent there Is provided a i method of manSfacturing a flushale urinary catheter comprising the steps of: provldimiq a dEgradabli pob!vinyl aicohol meterS1 and forming the poiwinyl altoh& raterial into a dheter tube, and toning tathetertubeto kØeterfltfe4pr £01 d utl1øtY CätMtøt The urinary catheter tube may be formed by any s4table process known to the skilled prsort1 Fr ekarnpIe,, the Urinary catheter tube ttat: blx fsrrne by? a process eIefld from ifljetjcfli: rpot4dittg. e4ruSkfl1 extrusion bJcw mot ding. Pnfrabi, the urinarcathetir tube tS manufactured by injection moulding or by: extrushrn blow moulding. In fl thecasc of atrusion blow mOulding, the catheter tube and tOflntttbr can be manth r fran the same matetial aPiitOr they t4 be manufactured so that they are integral.

:1 Brief Description of the Drawings

The invention will now be described in detail by way of example with reference to the accompanying drawings; in which; c Figure 1 shows a cross sectional view of one embodiment of the fiushable urinary catheter of the invention.

Detailed Description of the Invention

i wiH be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, unless circumstances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. In a preferred embodiment, a device in accordance with the invention comprises all aspects of the invention Within the context of this specification the word "comprises" is taken to mean "includes among other things". It is not intended to be construed as "consists of only".

Within this specification, the term "about" is interpreted to mean optionaUy ±20%, preferably optionafly ±10%, more preferably optionally ±5%.

Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99% 3° Referthtg to Figure l the urinary:cathMer I of the present Invention compriSes. cticter tube Ia hayIng a rud tiP at Its dIat!: end, and catheter connector lb attached to the proxlmS end al the catheter tube.

The catheter tube Is provIdedwith one or more drainage openings?3. lie * drainage openings 3 are provided wth ro:unded and or polished edges 4.

The tatheter tube ta is injection moulded and formed from a polyvinyl alcohol miteriát. The grade. of polyvinyl alcohol used ensures: that the catheter thbe la remáthsi insoluble hen It. isstored In seákd çckàIng and when It is insertS into the urethra during use. However, over a t6:jfl$ petio o time1 the mateilal jS? water-Stftenabie aia bk:d4fadable The material used is self-lubricating when wet and slghtjy adMslye or *adcy" when drying. In use1 this assiS In Insertion and retractIOn of the urinat catheter.

At a pfl)4rfl& end, the fla4 catheer 1 IS proviced with a: catheter c<nnector Sb, whkh may be used to attach the catheter tube la to a fESr catheter section or to a urine collection bag or other coflection device.

2ó The urtnaçy catheter 1 may have varying dimensions. In the ernodi* shown, for a femali user, the overall length ol the irinary catheter 1 is about 200 mm, and the outer diameter dct of the catheter tube Ia Is I: btiUt 6 thit. In an aftehtit embodinint, for a nait uséi the OVEPtIl length of the urinary catheter 1 Is about 4(10 mm, an4 the o*r d!arnete dcl of the catheter tube la Is about 6 mm. The thitkness of the catheter tube wall is configured to ensure a sufficient thickness for the tube to be I: Stable duiihg USE *hiltmlnihlSrn9the amount fiThteftI ft whidS the catheter tube is made: to ensure that it will dissolve after a In the: embodiment shown, the thickness of the catheter tube wail Is about 0.75 mm.

The above described embodiments have been given by way of example only, and the skifled reader wifl naturahy appreciate that many variations could be made thereto without deparbng from the scope of the claims 1f3