GB2529922A - Medical plug - Google Patents

Abstract

A medical plug for stomas comprises a cap 1 and an elongate flexible line 3. The line comprises a number of pre-formed discrete severance points 4 spaced apart along the length of the line. The line 3 may have a circular cross-section and the severance points 3 may be indentations which may extend around the entire circumference providing a reduced diameter. The severance points 4 may be at regular intervals. The cap 1 may comprise a tab 2 and a cut-out 9, 10 may be either side of the tab 2. The thickness of the cap 1 may be less than the width of the line 3. The plug may incorporate annular recesses providing longitudinal elasticity. The severance points 4 may have rounded upper edges 7, 8. The severance points 4 cause the line 3 to have a variable length.

Description

MEDlAi PLUG 15.E1&UbftJfl3CtjQfl The invention relates to medical plugs for stomas/ostomies or other surgical openings ii the body and in particular stoma plugs.

LathLthn Various diseases, conditions and surgeries can require the formation of a surgically made opening from the inside of an organ to the outside of the body. These openings are known as stomas and include: colastomies (an opening from the Large inteNtine to the abdominal walL so faeces bypass the ana canal); iieostomies (an opening from the small intestine to the abdominal wall so faeces bypass the large intestine and the anal canal) and urostomies (a connection between the urinary tract and abdominal wall so urine passes straight into a stoma bag and thus bypasses the urethra).

A stoma plug car be a necessay insertion to both seat the stoma opening in between catheter or colostomy bag insertions and also to prevent narrowing of the stoma, a condition known as stenosis, Stoma plugs are known in the prior art and generally are formed as a cap with a line of contLnuous dLarneter. The lines of the plugs are of a plurality of pre-determined Lengths.

Individuals' stornas may vary considerably in size and shape and whilst the prior art stoma plugs fuLfil their funcUon -these require improvement.

Various aspects of the invention seek to improve stoma plugs.

nmIthtimtentlQn.

lo In a first broad independent aspect, the invention provides a medical plug for stomas or the like comprising a cap and an elongate flexible line extending from said cap; said flexible line comprises a number of pre--forrued discrete severance points spaced apart. along the length of said line.

is The number of discrete severance points s particularLy advantageous because it allows the flexible line to be varied in Length in an accurate and repeatable manner. The flexible Line can be cut to the desired length based on the discrete severance points in an intuitive manner y the appropnate hardier of the pLug In a subsithary aspect, severance points are indentations.

This configuration is particularly advantageous because indentations can be easily provided n the Ire 1 base aLso vovde advantage3us f1exbday to the co ifigurauon Ihese are particularly intuitive for the handler and durable as there is no risk of them disappearing or fading. $5

In a subsidiary aspect, the flexible line is circular in cross-section and the indentations extend around the entire circumference to provide a reduced diameter.

This configuration is particularly advantageous because indentations which extend around the entire circumference provide a maximum Level of comfort to the user as an alternate shape would have a number of edges. They also facilitate the location of scissors or other devrces for sevenng the plug wrecpective of the cwcuriferent at ?rrt of ergagemnnt of such device.s n a krther subsdiary aspect, The severrce pa nts are prov3ded at regJar intervals along the Length of the flexible line.

This configuration is particularly advantageous because it allows the line to be varied hi Length to accurate pre-determined measurements. This is mportant as it is not a'ways o known what exact Length is needed. Once a required length is known, the regular intervals enable a user to select the Length with accuracy based on the Location and number of intervaLs, In a further subsidiary aspect, the cap comprises a Laterally protruding tab.

ic This configuration is particularly advantageous because ft enables improved handling of the plug which could Lead, if appropriate, to the easy removal of the plug from the stoma tract, n particular, the tab can be gripped and lifted independently of the cap so a user wilt not be required to have to obtain a grip on the cap, whith could CaUse irritation to the stoma entrance.

hi a furtier pecerred embothment, a cutQut s provded either side of the tab, at the junction between sad tab and said cap This configuraton is particularly advantageous because it increases the ease by whch the plug can be removed by the hancler anc decreases any chance of the protudirg tab becoming unattached from the cap when pulled, as would be the case if the tab was attached only at the edge of the cap circumference without the cut-outs at the junction.

na further subsidiay aspect, the thickness of the cap is less than the width of the line.

This configuration is particularly advantageous because it allows the cap to remain reLatively flat on the skin surface without rising too far and therefore can remain subtle beneath a plaster coder or clothing wiich is benehudi tu the usci, whilst the Line width is thkk enough to prevent the stoma from narrowing fri a further subsidiary aspect, the pLug incorporates annular recesses which provide a degree of Longitudinal elasticity.

This configuration ic patcularly advantageous becau;e it is important that the plug is soft and comfortable as stoma.s are not straight or rigid but often bend. The longitudinal elasticity increases the extent of stretchability, bendability and comfort for the handler and/or user as well as the comfort when inserting and removing the plug.

In a further preferred embodiment severance points are indentations with rounded tpper edges.

This configuration is particularly advantageous because ft means that after cutthg, the edges will remain rounded whch provides an Increased degree of comfort to the user whilst improving the lines ability of being inserted into the stoma.

Figure 1 shows a top view of a medical plug; Figure 2 shows a side view of the medical plug is flgure 3 shows a close up view of the fLexDie Ire, Figure 4 shows a perspective view of the medical plug; Figure 5 shows a side view of an embodiment of the medical plug; Figure 6 shows a side view of an embodiment of the medical plug and Figure 7 shows a diagrammatic view of the medical plug cut to various lengths.

The medical plug or stoma plug as shown in Figures 1 and 2 consists of a flat disc shaped cap I with a pull tab 2 and a bendable elongate line 3 extending from the centre of disc cap I WhiLst the elongate line may be preferably of a solid single piece of material, it may ao also he formed if appropriate for certain appLications as a cord formed of multiple blarrents The elongate me 3 compnses centmetre (cm) graduated severance points in the form of indentations 4. The line's indentations 4 may be graduated at smaller measurements such as half centimetres or millimetres (mm) to ncraase accuracy of length measurement. The severance points are shown more clearly in the clos&up image in Figure 3. The Line 3 is formed with the cap 1 as a single piece of material which may be produced by moulding or any other appropriate manufacturing technique.

In this preferred embodiment, the entire medical ptug is made from a high, medical grade a silicone suitabLe foi medical usage which has been tested for its ioconpatibthty The elongate line 3, disc cap 1 and pull tab 2 are made of the same medicaL high grade silicone which provides flexibility for an item that is to be inserted into the body. ft is important that the materiaL is biocompatible to enable it to perform fts desired function without eliciting any toxicity or undesirable systemic effects. Alternatively, the stoma plug may be made fran, a polymer which is preferably also of a medical grade.

The plug may be nserted flo he sto -na in conventional fashion until the rap 1 rnsts on the skin. The cord 3 can be lubricated with a water based lubricant durng this insertion to ease the placement. Preferably when the skin disc us flat on the skin it may be covered and secured with a dressing. When the cap 1 is flat on the skin, tab 2 also Lies flat. The provision of the tab provides the handler with the option of either covering the cap or the tab (or both) with an appropriate dressing.

For additional f exbi rty, the pull tab is provided o-either side with cutoLts 9 aid 10 which form recessed area about the perimeter of the cap between the tab and the substantially circular portion of the cap.

Whilst inserted within the stoma tract, the stoma plug maintains an adequate diameter of the stoma and helps to prevent cry stenosis from occurring. This is particularly important if catheter insertion Is difficult or if the site is closing.

When it is to be removed, for instance, when a catheter must be nserted the user or handler of the plug can pulL upwards on tab 2 to remove the cord from the stoma tract.

Figure 2 clearLy shows that the width of the cap? is far less than the diameter of the line 3 In use this s effective cc it means the cap will he on the ckin completely flat ard not be raised in any way, although in alternative embodiments the cap may have a raised portion.

The line 3 has a circular circumference which can be seen more clearly in Figure 4. The indentations 4 can also be shown to surround the entire circumference of the line.

Figure 4 aLso shows clearly that the upper edges land S of the indentations are rounded.

ft is possibLe for the nurse or other handLer to alter the length of the Line 3 by cutting at s one of the Lndentations 4. The indentations 4 are located at regular intervals of one centimetre which enabLes them to cut to an accurate desired Length.

Figures 5 and 6 show the plug cut to two different Lengths at the cm indentations 4. In use, a nurse may not know the required length for their stoma. This invention would aUow them to try various Lengths with just one stoma plug by beginning with the line at its longest Length and cutting at the cm indentations to find the correct suitable and most comfortable Length. rt can be seen in Figure 6 that, due to the rounded edges of the indentations, the bottom edge 6 consequentLy remains rounded when cut at the indentation, which, in use, provides an improved configuration for insertion into a patient is whilst providing additional comfort. to the user due to the absence of sharp corners or edges.

flgure 7 shows a diagrammatic figure of the severaL optional predetermined Lengths which may be obtained from a single initial plug AlternativeLy, the user may aLready know the exact length required and is able to cut to this Length easiLy and accurately.

Wording may be inscdbed into the top of the flat disc. The coLour of the silicone is UwngedbLe