GB2225956A

GB2225956A - Ostomy bag assembly

Info

Publication number: GB2225956A
Application number: GB8924862A
Authority: GB
Inventors: Kenneth John Brooks
Original assignee: Smiths Group PLC
Current assignee: Smiths Group PLC
Priority date: 1988-11-08
Filing date: 1989-11-03
Publication date: 1990-06-20
Also published as: ES2017317A6; JPH02172470A; GB8924862D0; FR2638633A1; DK554889A; DK554889D0; DE3935825A1

Abstract

A two-pant ostomy bag has a patient fitment 2 which is adhered to the skin 3 around a stoma 4 and on which is mounted a w.c. disposable bag 1. The fitment 2 has a plate 33 with a non-adhesive front surface 39 and a locating collar 38. The bag 1 has a wall of a w.c. disposable material including an inner water resistant layer 12A and an outer layer 12B of a material that is broken up or dispersed by water in a w.c. A bendable flange 15 is secured around an aperture 5 in wall of the bag by an adhesive layer 17 the inner region of which is exposed around the inside of the aperture. The exposed pant of the adhesive layer 17 is used to secure the bag 1 to the front surface 39 of the plate 33. After use, the bag 1 is removed from the fitment 2 and squeezed to expel gas. It is then folded across the flange 15 so that the adhesive layer 17 seals to itself and prevents air entering the bag when it is placed in the w.c. <IMAGE>

Description

MEDICO-SURGICAL COLLECTION BAG ASSEMBLIES This invention relates to medico-surgical collection bag assemblies.

The invention is more particularly concerned with two-part ostomy bag assemblies and the like, having a bag that is removable from a fitment attached to a user's skin around a stoma or other discharge outlet.

Ostomy bags are used to collect fecal matter discharged from a surgically made stoma in the patient's abdomen. In one form of bag, the opening to the bag is provided with an adhesive ring which is used to secure the bag either directly to the patient's skin around the stoma, or to an adhesive peristomal wafer adhered to the skin. The two-part ostomy bag assembly differs from this in that a fitment is adhered to the user's skin and the bag is separate from this, being mechanically coupled to the bag in a releasable manner by means of a relatively rigid coupling member on the bag. The bag is removed and disposed of when necessary by uncoupling from the fitment which remains in place to receive a new bag. The fitment can remain in place for several days before it also needs to be removed. Various forms of two-part assemblies have been proposed.These generally include a push-on, snap-fit type of coupling or some form of separate band that embraces the material of the bag around its opening after the bag material has been pushed over the patient's fitment. Examples of such bag assemblies are described in EP0259184A, EP 0270400A, EP 0213721A, US 4775374, GB 1455784, GB 1217406, GB 1568860, GB 1571986, GB 1579875, GB 1583027, GB2115288A, GB 2147810A, GB 2148120A, GB 2148716A, GB 2153683A, GB 2158719A, GB 2163350A, GB 2163959A, GB 2172204A, GB 2173403A, GB 2179556A, GB 2183481A, GB 2190841A, GB 2193097A, GB 2193098A, GB 2193098A, GB 2193439A, GB 2193893A, GB 2196257A, GB 2198953A, GB 2198954A, GB 2201345A, GB 2201346, GB 2201347A, GB 2205041A, GB 2206801A. These forms of assembly suffer from various disadvantages since they are either difficult for the patient to use, or cause discomfort during coupling or uncoupling.The difficulty of coupling and uncoupling previous assemblies can sometimes disturb the seal of the body-worn fitment with the skin and lead to leakage.

These couplings can also be bulky and obtrusive and may not flex with movement of the anatomy, leading to discomfort.

A further disadvantage is that the bags are not disposable in a w. c. This is because the material of the bag and the relatively rigid coupling ring on the bag provides an obstruction to flushing. Also, when disposing of a bag by flushing, it is necessary to remove air and gas in the bag prior to disposal so as to prevent it floating. With conventional w.c. disposable bags that are adhered directly to the user's skin, this is achieved readily by squeezing out the gas through the waste opening and then folding the adhesive region around the bag opening in half to seal the bag opening and prevent air re-entering the bag. Where a rigid coupling ring is used, as on conventional two-part bag assemblies, it is, of course, not possible to seal the bag in this way.

It is an object of the present invention to provide an improved form of bag assembly.

According to one aspect of the present invention there is provided a medico-surgical collection bag assembly for body waste products comprising a fitment which is arranged to be secured to the user around a body waste opening, and a collection bag which can be attached to the fitment in sealing engagement and released therefrom, the fitment including an adhesive layer arranged to adhere on its rear side to the user's skin and a plate member adhered to the front side of the adhesive layer the plate member having a non-adhesive planar front surface with a forwardly projecting locating collar, the collection bag having an adhesive region round an opening to the bag that is adapted to adhere to the planar front surface of the plate member, and the opening to the bag being adapted to be located relative to the body waste opening by means of the locating collar.

The collection bag may be w.c. disposable and, more particularly, the bag may have a wall of a w.c. disposable material including an inner layer of a water-resistant material presented inwardly to the contents of the bag and an outer layer of a material that is broken up or dispersed by water in the w.c.

The bag may include one or more non-adhesive release sheets, the release sheets being arranged to protect the adhesive region on the collection bag before use, and the release sheets being peelable from the adhesive region by pulling a part of the release sheet overlaying an outer part of the adhesive region. The or each release sheet may be folded back on itself and is preferably of annular shape.

The adhesive region on the collection bag is preferably supported on a flange secured to the bag around an aperture in a wall of the bag. The flange may be secured by an adhesive layer to the inner surface of a wall of the bag, the adhesive layer being exposed around the aperture in the wall. The adhesive layer of the fitment may be of circular shape and the fitment may include a ring of a microporous adhesive material that overlaps the outer edge of the layer.

The height of the locating collar is preferably sufficient to project through the opening of the bag.

According to another aspect of the present invention there is provided an ostomy bag assembly according to the above one aspect of the present invention, wherein the fitment is secured to the user around a surgically made stoma.

A two-part w.c. disposable ostomy bag assembly and its method of use, in accordance with the present invention, will now be described, by way of example, with reference to the accompanying drawings, in which: Figure 1 is a front view of the bag assembly separated; Figure 2 is a sectional view along the line Il-Il of Figure 1; Figure 3 is a sectional view of a part of the bag to a larger scale; Figure 4 is a front view of the patient fitment; and Figure 5 is an exploded sectional view along the line V - V of Figure 4.

With reference to Figure 1, the assembly comprises a w.c. disposable ostomy bag 1 and a user fitment 2 that is secured to the skin 3 of the user around a stoma 4. The bag 1 is provided with a coupling 10 around its opening ill that can be secured to the fitment 2 and removed from it when necessary, leaving the fitment in position on the user.

With reference now also to Figures 2 and 3, the bag 1 has two flexible plastics sheets 12 of a w.c. disposable material which are welded together around their edge 13 to form the walls of a bag that is sealed apart from its opening 11 and an optional filtered flatus vent 14. The material used to form the sheets 12 may be of the kind used in the ostomy bag sold by Eschmann Bros. & Walsh Limited under the trade mark SYMPHONY. The material comprises a thin, water resistant layer 12A that is presented inwardly to the contents of the bag and a thicker outer layer 12B that is broken up or dispersed in turbulent cold water so that the inner layer can collapse or break up without providing an obstacle to flushing. A circular aperture 5 is formed in the sheet 12 which, in use, is against the body of the user. The coupling 10 is shown in more detail in Figure 3 and includes an annular stiffening ring or flange 15 secured to the inner surface of the sheet 12 around the aperture 5 by means of a ring 17 of adhesive material on the front surface on the flange. The flange 15 is of a bendable plastics material which is stiffer than the sheet 12 and is of circular shape.

The outside diameter of the flange 15 is larger than the diameter of the aperture 5 in the sheet 12, whereas the inside diameter of the flange 15 is smaller than the aperture, so that the central opening of the flange provides the opening 11 to the bag. About half the width of the flange 15 is exposed within the aperture 5 so that the inner part of the adhesive ring 17 is also exposed around the opening 11 of the bag.

Prior to use, the exposed part of front surface of the adhesive ring 17 is protected by two release sheets 23 and 24.

Each release sheet 23 and 24 is of a non-adhesive material, such as siliconized paper, which can be removed readily from exposed part of the adhesive ring 17. The sheets 23 and 24 are both of annular shape with a circular central aperture the same diameter as the opening 11 and are generally square in shape externally with rounded corners. The sheets 23 and 24 are folded along a line close to their diameter so that one half of the sheet overlies the other; the underneath alf of each sheet releasably adheres to the adhesive ring 17 whilst the other half is free, as shown in Figure 2. The release sheets 23 and 24 are, in fact, slightly larger, when opened flat, than the exposed part of the adhesive ring 17 so that their folded edges overlap one another on the adhesive, thereby ensuring that none of the adhesive is exposed.

With reference now also to Figures 4 and 5, the user fitment 2 is secured to the user's skin 3 by means of an adhesive layer in the form of a disc 30 on the rear of the fitment. The disc 30 is of a hydrophilic polymer in a support matrix of a hydrophobic polymer, such as SEEL-A-PEEL (a Registered Trade Mark of Eschmann Bros. & Walsh Limited). The disc 30 is circular with a central aperture 31, selected in size according to the size of the user's stoma 4. Prior to use, the rear surface of the disc 30 is protected by a release sheet 32.

An annular, circular plate member 33, moulded from a semi-rigid but bendable plastics, is adhered to the front surface of the disc 30 by means of an adhesive 34 on the rear surface of the plate. The outer diameter of the plate 33 is less than that of the disc 30, the exposed periphery of the disc being covered by an annular ring 35 of microporous tape which is thinner than the disc. The external diameter of the microporous ring 35 is greater than that of the disc 30 so that it overlaps the disc around its outer edge. The rear surface of the ring 35 is adhesive and is protected, prior to use, where it overlaps the disc 30, by an annular release sheet 36.

The plate 33 is about 0.5mm thick with a central aperture 37 around which a locating collar 38 projects forwardly. The height of the collar 38 above the plate 33 is about 3mm, which is at least high enough to project through the coupling 10. Its external diameter is slightly smaller than the diameter of the aperture 11 in the flange 15 of the bag coupling 10. Around the outside of the collar 38, the plate 33 provides a flat, planar, front surface 39 which is non-adhesive but which can form a secure, releasable sealing bond with the adhesive layer 17 on the bag coupling 10.

In use, the user first secures the fitment 2 to the skin 3 around the stoma 4 by removing the release sheet 32 from the disc 30 and the release sheet 36 from the microporous ring 35 and smoothing the disc and sheet onto the skin. The microporous ring 35 helps prevent the outer edge of the disc 30 lifting away from the skin.

The user then takes hold of the ostomy bag 1, with its release sheets 23 and 24 still in position, and places it against the fitment 2 so that the collar 38 locates in the opening 11 of the bag, and so that the bag is correctly aligned to hang vertically.

The free edge of each release sheet 23 and 24 is then gripped in turn and pulled outwardly, parallel to the surface of the bag 1 so that they peel away from the centre of the adhesive ring 17. In this way, the underlying adhesive 17 is exposed and can be brought into contact with the front surface 39 of the plate 33 by gentle pressure. This provides secure retention of the bag 1 on the fitment 2 and seals the coupling between the bag and the fitment against leakage of body waste products entering the bag.

When the bag 1 needs to be removed, the user grips both the bag 1 and the plate 33 and peels the bag coupling 10 away from the patient fitment 2, leaving the fitment in position on the user's skin. The bag 1 is then squeezed to expel air and gas through the opening 11 and the bag folded about a diameter of the flexible flange 15 so that the surface of the adhesive layer 17 is folded on top of itself and seals the opening. Alternatively, the bag 1 can be sealed in this way prior to expelling gas through the flatus vent 14 by squeezing. This effectively prevents air entering the bag so that it can be dropped into the pan of a w.c. with less risk of floating. The fitment 2 need only be replaced after several days.

The thin, flexible nature of the flange 15 and hence the coupling 10 ensures that it can be flushed away around the waste pipe of a w.c. without obstruction. The adhesive 17 can also be water soluble which facilitates disposal of the bag With a bag assembly of this kind it is possible to provide a secure coupling with a low profile so that there is no conspicuous bulge beneath the user's clothing. The user part of the coupling can also be made bendable so that it conforms with the anatomy.

Various modifications to the assembly are possible.

For example, the flange 15 could be joined to the outer surface of the bag. It is preferable for the release sheets 23 and 24 to be removable when the bag 1 is adjacent the patient fitment, such as by pulling a part of the sheets overlaying an outer region of the adhesive, but this can be achieved with different arrangements of release sheets.

The invention is not confined to use with w.c.

disposable bags but could be used with any conventional two-part medico-surgical collection bag. In this respect the invention could also be used for ileostomy or urostomy applications.

Claims

1. A medico-surgical collection bag assembly for body waste products comprising a fitment which is arranged to be secured to the user around a body waste opening, and a collection bag which can be attached to the fitment in sealing engagement and released therefrom, wherein the fitment includes an adhesive layer arranged to adhere on its rear side to the user's skin and a plate member adhered to the front side of said adhesive layer, wherein the plate member has a non-adhesive planar front surface with a forwardly projecting locating collar, wherein the collection bag has an adhesive region round an opening to the bag that is adapted to adhere to the planar front surface of the plate member, and wherein the opening to the bag is adapted to be located relative to the body waste opening by means of said locating collar.

2. A bag assembly according to Claim 1, wherein the collection bag is w.c. disposable.

3. A bag assembly according to Claim 2, wherein the bag has a wall of a w.c. disposable material including an inner layer of a water resistant material presented inwardly to the contents of the bag and an outer layer of a material that is broken up or dispersed by water in the w.c.

4. A bag assembly according to any one of the preceding claims, including one or more non-adhesive release sheets, wherein the release sheets are arranged to protect the adhesive region on the collection bag before use, and wherein the release sheets are peel able from the adhesive region by pulling a part of the release sheet overlaying an outer part of the adhesive region.

5. A bag assembly according to Claim 4, wherein the or each release sheet is folded back on itself.

6. A bag assembly according to Claim 4 or 5, wherein the or each release sheet is of annular shape.

7. A bag assembly according to any one of the preceding claims, wherein the adhesive region on the collection bag is supported on a flange secured to the bag around an aperture in a wall of the bag.

8. A bag assembly according to Claim 7, wherein the flange is secured by an adhesive layer to the inner surface of a wall of the bag, and wherein the adhesive layer is exposed around the aperture in the wall.

9. A bag assembly according to any one of the preceding claims, wherein the adhesive layer of the fitment is of circular shape and the fitment includes a ring of a microporous adhesive material that overlaps the outer edge of the layer.

10. A bag assembly according to any one of the preceding claims, wherein the height of the locating collar is sufficient to project through the opening of the bag.

11. An ostomy bag assembly according to any one of the preceding claims, wherein the fitment is arranged to be secured to the user around a surgically made stoma.

12. An ostomy bag assembly substantially as hereinbefore described with reference to the accompanying drawings.

13. Any novel feature or combination of features as hereinbefore described.