Improvements in or relating to stoma bags

Abstract

A stoma bag comprising an apertured 3a fastener 4 secured to a first wall member 2 that can be removably secured around a patient's stoma and a secondary wall member (FIG.3:3) defining an expandable c

Description

This invention is concerned with an improvement to a stoma (or ostomy) bag. More particularly the invention is directed to a modified stoma bag through which it is possible and practical to pass a patient liquid nutrient feed line, so a feed line may be passed (once the bag is fitted in place around t he stoma) through the stoma and routed by manual passage into a stoma patient's stomach. Patients with stomas require disposable stoma bags in which the patient waste can be collected and then disposed of multiple times through a resealable outlet before the whole bag itself requires disposal at the end of its useful service life. Conventional such stoma bags have a connector that releasably attaches to a co-operating connector secured to the patient's skin around the region of the stoma. Quite apart from the need to collect patient waste from a stoma patient, which function is fulfilled by the conventional stoma bag, there is a need to ensure such patients are and continue to be fed whilst the bag is in place. Often times, conventional eating by mouth is either not possible or significantly compromised in stoma patients. In order to feed such eating-compromised stoma patients, a supply of liquid nutrient feed, often referred to as 'TPN' must reach their stomach. Conventionally a liquid nutrient feed is given to the stoma patient via a hollow flexible tube (herein 'feedline') inserted through the nasal passageways such that an open end of the feedline terminates within the stoma patient's stomach. However, in the case of many stoma patients, use of a liquid nutrient feedline through the nasal passageways is prevented since the patient typically already has other nasal routed tubes in place that hinder or prevent use of yet another nasal routed tube. For instance, these other nasal routed tubes can be installed and operating to aspirate bile from the gut, given that production and use of bile in the stoma patient is adversely affected and needs monitoring and adjusting. The alternatives to nasal passageway routed feed line Include feedline insertion through a cannula or PICC line, in which the cannula or PICC line is inserted into a vein, and the feed line passed through the cannula or PICC Une, into and through that vein, so the liquid nutrient feed is thereby fed directly into the bloodstream, from which it reaches the patient's stomach for eventual proper digestion. Yet another stumbling block arises in the case of feeding stoma patients, creating yet more difficulty in delivering a liquid nutrient feed into their stomachs. These patient's veins become dehydrated as a result of the relatively long care in hospital or in the home. Such patients also tend to require numerous periodic blood tests and cannulation for such purposes. This makes it yet more difficult to insert further or new cannulas or PICC lines that would specifically be for liquid nutrient feeding. To solve the problem of how to feed stoma patients with liquid nutrient feed, where that patient is conventional feeding compromised required some ingenuity on the part of stoma nursing staff caring for these patients. It was considered that the feedline would somehow need insertion through the stoma to reach the stoma patient's stomach, but the stoma bag itself presented an obstacle as they need to be in and remain in position most if not all of the time, and so presented a barrier to getting the feedline through the stoma. The solution to this problem has been to compromise the integrity of the stoma bag itself by making, a tear or incision into an external wall of the bag and passing the feedline through the tear or incision and through the stoma into the patient's stomach. Unfortunately, this leads to its own further problems, so this solution has been less than ideal. Tearing or cutting part of the bag wall allows patient waste to leak over the patient and onto the bedding. The stoma bag function of containing the waste until it can be emptied, multiple times, through the usual resealable drainage outlet is thereby compromised. The procedure is also economically quite wasteful of stoma bags, because once ruptured in this intentional manner, their normal service life Is drastically diminished. Unwanted leakage of patient waste is also uncomfortable and distressing to the patient, and inefficient to nursing and auxiliary staff because of the resultant excessive laundry needs. It is from a consideration of existing techniques for inserting and using a feedline in the stoma patient and the above partially destructive approach that has led to the present invention. According to this invention, in one aspect, there is provided a stoma bag comprising an apertured fastener secured to a first wall member of the stoma bag, which fastener can be removably secured around a patient's stoma, and the bag having a secondary wall member opposite the first wall member, the wall members defining between them an expandible chamber capable of receiving output from a patient's stoma, wherein the secondary wall member is provided with inlet means Including a conduit member in communication with the expandible chamber, the conduit member adapted to removably receive a patient liquid feeding tube in a manner permitting It to removably pass beyond the conduit member into the expandible chamber and through and beyond the aperture in the apertured fastener. The conduit preferably comprises a generally hollow sleeve. The invention includes such a bag in combination with such a patient feeding tube, wherein the sleeve is a close interference fit with the tube avoiding, in use, leakage of such patient output whilst still permitting sliding movement of the tube through the sleeve. The inlet means may comprise a flange secured to an external face of the secondary wall member, the sleeve being connected to the flange. The conduit may extend through the expandible chamber such that Its outlet Is positioned above the centre of the aperture In the apertured fastener. The conduit is preferably positioned so that its outlet within the expandible chamber lies within the uppermost region of the aperture in the apertured fastener. The bag preferably includes a third wall member between the first and secondary wall members. Such a third wall member ideally comprises a substantially liquid impervious membrane. Such a substantially Impermeable membrane ideally comprises an integral feature of the bag. Such a membrane preferably divides the bag internally into a pair of adjacent expandible chambers. In another aspect of the present invention, there is further provided a stoma bag comprising opposing front and back panels of liquid impervious material interconnected in a mannei Lu prevent fluid seepage about a major portion of their mutual peripheries, the panels defining between them an expandible reservoir adapted to receive waste matter from a patient's stoma when the bag is fitted thereto, the interconnected panels also forming in the region of an end thereof a resealable waste outlet through which a patient's waste can be drained, one panel having a stoma connector affixed thereto which can be removably connected to a co-operating fastening member attachable to a region of a patient surrounding such a stoma, the other panel provided with inlet means constructed and positioned to enable (I) a patient feeding tube to be removably inserted therein and to pass through said stoma connector, and when the bag is secured in position upon said fastening member to enable (ii) removable passage of such a patient feeding tube through and beyond such a patient's stoma, said inlet means further being so constructed and secured to that other panel in such a manner as to prevent leakage, in use, of patient waste past said Inlet means, whilst permitting, In use, flow of patient feed through said tube into said patient's stoma without its contamination by patient waste when contained within said expandable reservoir. A stoma bag according to this other aspect may additionally comprise any one or more other constructional features of a bag as has been specified above. In a still further aspect of the present Invention there is provided a stoma bag comprising on one external face a stoma inlet aperture, and a secondary inlet on another face of the bag, the interior of the stoma bag comprising at least two adjacent expandible chambers, a waste-product such chamber in communication with said inlet aperture and having resealable waste exit means from the bag, a non-waste such chamber adjacent said waste product chamber and separated therefrom by a substantially liquid Impervious membrane, the secondary inlet including a conduit extending from said external face of the bag through the non- waste chamber into the waste chamber to terminate in the vicinity of the stoma inlet aperture, said conduit positioned and adapted to removably receive a patient feeding tube capable of removable Insertion into said conduit so as to pass from the stoma bag exterior, through said external face and through said waste product chamber, said membrane and through the non- waste chamber and through and beyond said stoma inlet aperture. In order that the invention may be illustrated, more easily appreciated and readily carried into effect by those skilled In the art, embodiments of the present invention will now be described purely by way of non-limiting example with reference to the accompanying drawings, and in which: Figure 1 is a plan view of a conventional, un-modified stoma bag that is widely available and already known in this art, Figure 2 is a plan view of a conventional patient stoma-surround, that is used with the known stoma bags and is proposed also to be used in connection with the modified stoma bags of the present invention, Figure 3 is a plan view of the front of a modified stoma bag according to an embodiment of the invention, Figure 4 is a plan view of the other (rear) side of the modified bag depicted In Figure 3, note particularly the region of the aperture within the stoma connector, Figure 5 is an isometric view of a partly disassembled but enhanced modified stoma bag according to a further embodiment of the invention, Figure 6 is a plan view of the enhanced modified stoma bag embodiment introduced in Figure 5, in which part of the wall member has been upturned to expose the additional liquid impervious layer, Figure 7 is a further depiction of the enhanced modified bag shown in Figures 5 and 6,, but wherein both an outer wall member and the additional impervious layer have been partially separated at their common peripheral edge and then upturned to reveal the inside of the far (front) wall member, Figure 8 is a side elevational view of the enhanced modified stoma bag shown in Figures 5 to 7, showing adjacent internal chambers separated by the additional impervious layer, and Figure 9 is an expanded partial close-up of the enhanced bag of Figure 8, in which a user is expanding the adjacent chambers feature of the enhanced, modified stoma bag. Referring to the drawings and initially to Figure 1 thereof, a conventional stoma bag 1 is depicted in plan view from above, in which a front panel 2 has an aperture 3a, around the periphery of which a stoma connector 4 is securely fitted. The stoma connector 4 has a perforated flange 4a on each side. The front panel 2 is securely connected to a rear pane! 3, around their common periphery 3b. Between the front 2 and rear 3 panels, an internal expandible hollow chamber is created, which is designed and arranged to hold human waste material, when it exits the stoma (not illustrated) and passes through the typically circular aperture of the stoma connector. To this extent the internal surfaces of both front and rear panels are liquid impervious. A waste outlet gap 5 is located at the lower end edge of the front panel and an internal surface 6 of the rear panel, which surface part 6 forms a movable, sealable and releasable flap. A removable strip 7 is provided at the lowermost edge of the rear panel 3. This can be removed to expose an adhesive strip whereby the flap 6 can be folded over and adhesively fastened to an outer surface part of the front panel 2. The flap 6 can be folded, fastened and un-fastened several times. This action of folding the flap and adhesively securing same to an outer surface part of the front panel, closes the gap and thereby the chamber that exists internally between front and back panels, but for the stoma connector aperture 3a. In use, the stoma connector aperture 3a will be in liquid communication with the patient's stoma, so effectively the expandible internal chamber is closed off by the sealed flap, until it is required to be opened for drainage of contents. Thus, the conventional stoma bag has no inlet to permit a tube (feedline) to be passed into the patient's stomach for feeding. Figure 2 moves on to .show .a cpnyentip.n.a.1 stoma surround cpnneptpr 8, to be fitted around the stoma, and having means adapted for connection to the stoma connector of the bag 1 shown in Figure 1. A patch 10 of translucent, adherent material has a protective film 9 over the adherent underside, which upon removal allows application of the adherent patch surface to the patient in the region of and overlaying the stoma (not shown). The connector 8 has an engagement fitment 11 of a suitable plastics material (similar to the plastics material of connector 4) firmly affixed to the patch 10. This fitment 11 has an aperture that corresponds to the aperture 3a of connector 4 and is of a shape and size that permits its fitment to the said connector 4 of the stoma bag. Raised projections 13a assist in such connection, as does a raised circular lip around the periphery of the said aperture adapted to engage with a co-operating circular recess in the mating surface of connector 4. The patch material extends into the internal region 12 of said fitment aperture. A central smaller aperture 13 is provided in the patch to reduce the size of the aperture in the fitment, to allow for passage of waste material through the patch into the stoma bag and to minimise back-flow of waste material from the stoma bag back into the patient which may otherwise occur. Referring to Figure 3 a modified stoma bag according to an embodiment of the invention is shown. Here we see, in plan view, the rear panel 3 with waste outlet gap 5 at its lower end, with the back panel 3 being affixed to a co-operating front panel along their periphery 3b. The modification over conventional is in the provision of an inlet means 15, part of which projects through yet another aperture 14 in the said rear panel 3. The inlet means has a hollow tubular projection, in communication with the interior 16 of the stoma bag. The tubular projection 15 is in the region of and opposite the aperture 3a of the stoma connector 4. The inlet means 15 does not have to align, in use, with the smaller aperture 13 of the patch, but it needs to be in fluid communication therewith. Figure 4 shows the bag of figure 3, inverted, so the arrangement and shape of the modified stoma bag of this invention can be compared more directly with the conventional bag of figure 1. Thus, we have in Figure 3 the front panel 2 attached to a rear panel 3 about their periphery 3b. The same stoma connector 4 is present on the front panel 2. Within the region of the stoma connector aperture, but on the rear panel 3 the said inlet means 15 are provided. This has a generally flat flanged component 17 that is secured to an Internal surface of the rear panel, and a hollow tubular component 15 leading out of the bag but in fluid communication therewith. In this embodiment, it is this tubular component that allows a feed line to be passed through (see Figure 3) the bag, the stoma connector and the patch, through the aperture in the patch and then into the stoma patient's stomach (not shown) without destructive damage to the stoma bag. By using a tight-fitting such feeding line, in the sense of a tight fit between that feed line (not shown) and the interior of the tubular component 15, the feed line can remain in place whilst waste is discharged into the stoma bag. So the stoma bag can be emptied and re-used several times before ag replacement becomes necessary. In other words the modified stoma bag can be used as normal, whilst the patient is given liquid feed via a tube that passes throughout the said tubular component. Figure 5 shows a modified embodiment, wherein an additional water-impervious layer 18 is to be Interposed between front 2 and rear 3 panels of the stoma bag. The maximum height of the sheet 18, once positioned, exceeds the comparative height of the stoma patch aperture (see Figure 2) but lies below the relative height of the feed line tubular component 15. This is to further keep the patient waste away from the tubular component and any feed line inserted therein, therefore a more hygienic version of the modified stoma bag according to the invention. Figure 6 shows the internal arrangements of the figure 5 embodiment. The additional water-impervious layer 18 is interposed between front 2 and rear 3 panels. The common peripheral edging is to be fastened together, save for the emptying gap 5. The front panel has been folded back on itself along a fold line 3d to show more clearly the interposed additional hygienic layer 18. In figure 7, the interposed additional hygienic layer 18 is also folded back along Its fold line 3c, to reveal the internal surface layer of the rear panel 3, a small part of the front panel just being visible. Figure 8 shows a side view of a partially disassembled modified stoma bag, of the type illustrated in Figures 5,6 and 7, the layer 18 interposed between front 2 and rear 3 panels, with the common peripheral edge separated and the three layers pulled apart to show this internal view. Figure 9 is a view similar to Figure 8, in which a hygienic layer 18 Is being separated from a rear panel 3 by hand.

Claims

1) A stoma bag comprising an apertured fastener secured to a first wall member of the stoma bag, which fastener can be removably secured around a patient's stoma, and the bag having a secondary wall member opposite the first wall member, the wall members defining between them an expandible chamber capable of receiving output from a patient's stoma, wherein the secondary wall member is provided with inlet means including a conduit member in communication with the expandible chamber, the conduit member adapted to removably receive a patient liquid feeding tube in a manner permitting it to removably pass beyond the conduit member into the expandible chamber and through and beyond the aperture In the apertured fastener.2) A stoma bag as claimed in claim 1, wherein the conduit comprises a generally hollow sleeve.3) A bag as claimed in claim 2, in combination with such a patient feeding tube, wherein the sleeve is a close interference fit with the tube avoiding, in use, leakage of such patient output whilst still permitting sliding movement of the tube through the sleeve.4) A bag as claimed in claim 2 or 3, wherein the inlet means comprises a flange secured to an external face of the secondary wall member, the sleeve being connected to the flange.5) A bag as claimed in any preceding claim, wherein the conduit extends through the expandible chamber such that its outlet is positioned above the centre of the aperture in the apertured fastener.6) A bag as claimed in claim 5, wherein the conduit Is positioned so that its outlet within the expandible chamber lies within the uppermost region of the aperture in the apertured fastener.7) A bag as claimed in any preceding claim which includes a third wall member between the first and secondary wall members.8) A bag as claimed in claim 7, wherein the third wall member comprises a substantially liquidimpervious membrane.9) A bag as claimed in claim 8, wherein the substantially impermeable membrane comprises an integral feature of the bag.10) A bag as claimed in claim 8 or 9, wherein the membrane divides the bag internally into a pair of adjacent expandlble chambers.11) A stoma bag comprising opposing front and back panels of liquid impervious material interconnected in a manner to prevent fluid seepage about a major portion of their mutual peripheries, the panels defining between them an expendible reservoir adapted to receive waste matter from a patient's stoma when the bag is fitted thereto, the interconnected panels also forming in the region of an end thereof a resealable waste outlet through which a patient's waste can be drained, one panel having a stoma connector affixed thereto which can be removably connected to a co-operating fastening member attachable tom a region of a patient surrounding such a stoma, the other panel provided with inlet means constructed and positioned to enable (I) a patient feeding tube to be removably Inserted therein and to pass through said stoma connector, and when the bag is secured in position upon said fastening member to enable (ii) removable passage of such a patient feeding tube through and beyond such a patient's stoma, said inlet means further being so constructed and secured to that other panel in such a manner as to prevent leakage, in use, of patient waste past said inlet means, whilst permitting, In use, flow of patient feed through said tube into said patient's stoma without its contamination by patient waste when contained within said expandable reservoir.12) A stoma bag as claimed in claim 11 additionally comprising any one or more other constructional features of a bag as defined in any one of claims 2 to 10.13) A stoma bag comprising on one external face a stoma inlet aperture, and a secondary inlet on another face of the bag, the interior of the stoma bag comprising at least two adjacent expandible chambers, a waste-product such chamber in communication with said inlet aperture and having resealable waste exit means from the bag, a non-waste such chamber adjacent said waste productchamber and separated therefrom by a substantially liquid impervious membrane, the secondary inlet including a conduit extending from said external face of the bag through the non- waste chamber into the waste chamber to terminate in the vicinity of the stoma Inlet aperture, said conduit positioned and adapted to removably receive a patient feeding tube capable of removable insertion into said conduit so as to pass from the stoma bag exterior, through said external face and through said waste product chamber, said membrane and through the non- waste chamber and through and beyond said stoma inlet aperture.

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