FILM FOR AN OSTOMY BAG

Abstract

A film for an ostomy bag has a first surface and an opposing second surface, the thickness of the film being the distance between each surface, and a plurality of projections are defined in the surfaces to provide a plurality of surface reliefs which are debossed and/or embossed into the film. The film makes minimal noise when one part of the film is moved in relation to another part of the film.

Claims

1. A film for an ostomy bag wherein the film has a first surface and an opposing second surface, the thickness of the film being the distance between the first and second surfaces, and a plurality of projections are defined in at least one of the surfaces to provide a plurality of surface reliefs which are debossed and/or embossed into the film.

2. A film according to claim 1, wherein each projection defines a peak in one of the first or second surfaces and a corresponding valley in the other surface.

3. A film according to claim 1, wherein the projections are spaced apart from each other to define a repeating pattern.

4. A film according to claim 1, wherein the first and second surfaces of the film have a pattern of projections defined therein substantially over the entire surfaces.

5. A film according to claim 1, wherein each projection has a base from where each projection extends from the surface of the film and a cross section parallel to the base, wherein the base and/or the cross section has the shape of a circle, oval, ellipse, square, rectangle, rhombus, lozenge, trapezium, parallelogram, triangle, pentagon, hexagon, heptagon, octagon, nonagon or decagon.

6. A film according to claim 5, wherein each projection has a base from where each projection extends from the surface of the film and a cross section parallel to the base, wherein the base and/or cross section have the shape of a hexagon.

7. A film according to claim 1, wherein the film has a thickness of about 50 m to about 100 m.

8. A film according to claim 1, wherein each projection defines a cylinder or pocket.

9. A film according to claim 1, wherein each projection has a height from the adjoining surface of the film of about 2 mm.

10. A film according to claim 1, wherein each projection is located in a rectangular envelope having a width () and a length () on a surface of the film and each projection abuts the edge of the envelope so that it maximises the space that it occupies in the envelope

11. A film according to claim 10, wherein is about 4 mm to about 10 mm

12. A film according to claim 10 wherein is about 2 mm to about 5 mm.

13. A film according to claim 10 wherein the centre of each envelope is located a distance x parallel to and a distance y parallel to to the centre of an adjacent envelope.

14. A film according to claim 13, wherein distance x is about 3 mm to about 6 mm.

15. A film according to claim 13, wherein distance y is about 2 mm to about 4 mm.

16. A film according to claim 13, wherein x is about 3 mm or about 6 mm, y is about 2 mm or about 4 mm, is about 4 mm or about 8 mm, and is about 2 mm or about 4 mm.

17. A film according to claim 1, wherein adjacent projections extend from the film in opposing directions, i.e. from both surfaces of the film.

18. A film according to claim 1, wherein adjacent projections extend from the film in the same direction, i.e. from the same surface of the film.

19. A film according to claim 1, wherein each projection is formed by treatment of a film which comprises the steps of applying one or more of infra-red radiation, forced (hot) air, induction heating, convection heating, selective (localised) heating, compressed air or an air knife/slot.

20. A film according to claim 1, wherein the projections are formed by one or more of knurled rollers, press (blow moulding), vacuum forming (over a bed or rollers) or by stamping to create an impression.

21. A film according to claim 1, wherein the film is preferably of ethylene vinyl acetate (EVA) or a barrier film laminate having about 5 to about 7 layers, for example a laminate of ethylene vinyl acetate, ethylene vinyl acetate, polyvinylidene chloride, ethylene vinyl acetate, ethylene vinyl acetate (EVA, EVA, PVDC, EVA, EVA) respectively.

22. A film according to claim 1, wherein the film is preferably selected from a non-laminated film wherein a plurality of projections defined therein or a laminated film wherein each layer of the laminate has a plurality of projections defined therein or at least one layer of the laminated film has a plurality of projections defined therein.

23. A film according to claim 22, wherein a laminated film is selected from a glue laminated film or a non-glue laminated film.

24. An ostomy bag having a pouch comprising 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 and including in at least one of the walls a film according to claim 1.

25. An ostomy bag according to claim 24, wherein the walls are welded together at their edges.

26. An ostomy bag according to claim 24, wherein a flange abuts the inlet.

27. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The invention will now be described by way of example with reference to the accompanying drawings, in which:

[0044] FIG. 1 shows the location of projections within envelopes and their location with respect to each other in an embodiment of a film according to the invention. It will be appreciated that projections having cross sections of other shapes not specifically shown also fall within the invention;

[0045] FIG. 2A shows a view of two projections in an embodiment according to the invention wherein adjacent projections extend from the film in opposing directions; and FIG. 2B shows a view of two projections in an alternative embodiment according to the invention, wherein adjacent projections extend from the same surface of the film;

[0046] FIGS. 3, 4 and 5 show views of various cross sections of projections within envelopes in embodiments of films according to the invention; and

[0047] FIG. 6 shows a view of an ostomy bag comprising a film according to the invention together with a magnified section of the film showing projections provided in the surface of the film.

DETAILED DESCRIPTION OF THE INVENTION

[0048] It will 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.

[0049] Within the context of this specification, the word about means preferably plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%.

[0050] Within the context of this specification, the word comprises means includes, among other things and should not be construed to mean consists of only.

[0051] Within the context of this specification, the word substantially means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%.

[0052] Referring now to FIGS. 1 to 6, FIG. 1 shows the location of projections (2) within envelopes (3) and their location with respect to each other in an embodiment of a film (1) according to the invention. Each projection (2) is located in a rectangular envelope (3) of a specific size on a surface of the film (1) and the corners of each projection (2) abut the edge of the envelope (3). In this regard, each envelope (3) has a width () and a length (). The centre of each envelope (3) is located at a specific distance away from other envelopes (3). In this regard, the centre of one envelope (3) is a distance x parallel to and a distance y parallel to to the centre of an adjacent envelope (3).

[0053] FIG. 2 shows a view of alternative embodiments of films (1), wherein FIG. 2A shows two projections (2) extending from alternative surfaces of the film (1); and FIG. 2B shows two projections (2) extending from the same surface of the film (1). The projections have a height (z).

[0054] FIGS. 3, 4 and 5 show cross sectional views of alternative embodiments of projections (2) within envelopes (3). Various shape projections in cross sectional view are shown.

[0055] FIG. 6 shows an ostomy bag (10) according to the invention. It has a flange (11) which comprises an annular disk arranged to surround a stomal opening and having a radially inner edge (12) and a radially outer edge (13), the flange (11) having a body facing surface (14) and a pouch facing surface for attachment to a pouch (15).

[0056] In an embodiment, the flange (11) is manufactured from a hydrocolloid disc, for example formed of a visco elastic polymer mixed with natural hydrocolloids by heating and pressing and/or by vacuum forming. The flange (11) is provided with a generally central aperture (16) through which the stoma of a user may protrude during use.

[0057] The pouch facing surface of the flange typically is bonded to an ostomy appliance such as the pouch (15) of an ostomy bag, for example by means of adhesive or by welding.

[0058] In use, the flange (11) with ostomy appliance attached is affixed to the skin of the patient is about the stomal opening, the hydrocolloid adhesive serving to adhere the flange to the skin of the patient. The adhesive seals the flange against the skin. The seal between the flange and the skin serves to prevent waste materials from the stomal opening leaking out of the pouch.

[0059] In an embodiment the flange (11) has a uniform thickness of about 0.6 mm to about 1.8 mm, for example 1 mm.

[0060] According to the invention, the bag can be a stoma bag, for example an ileostomy, colostomy, or urostomy bag. In addition it can be a closed bag, or a drainable bag having an opening through which the bag may be drained.

EXAMPLE 1

[0061] Test Method and Programme

[0062] To test embodiments of the invention after vacuum forming, sound tests were carried out by twisting and scrunching up differing vacuum formed films having a plurality of projections defined in their surfaces and measuring the level of sound generated by the film using a sound meter. Each film tested had projections of varying size, pitch and depth defined in their surfaces.

[0063] Details of the various films and projections are described below:

TABLE-US-00001 Pitch (mm) Sample x y z 1A 3 2 2 4 2 1B 4.5 3 2 4 2 1C 6 4 2 4 2 1D 7.5 5 2 4 2 1E 9 6 2 4 2 10.5 7 2 4 2 12 8 2 4 2 13.5 9 2 4 2 15 10 2 4 2 1F 16.5 11 2 4 2 18 12 2 4 2 19.5 13 2 4 2 1G 21 14 2 4 2 22.5 15 2 4 2 24 16 2 4 2 25.5 17 2 4 2 27 18 2 4 2 28.5 19 2 4 2 30 20 2 4 2 31.5 21 2 4 2 33 22 2 4 2 1H 34.5 23 2 4 2 36 24 2 4 2 37.5 25 2 4 2 1I 39 26 2 4 2 40.5 27 2 4 2 42 28 2 4 2 43.5 29 2 4 2 45 30 2 4 2 1J 46.5 31 2 4 2 48 32 2 4 2 49.5 33 2 4 2 1K 51 34 2 4 2 52.5 35 2 4 2 54 36 2 4 2 55.5 37 2 4 2 57 38 2 4 2 58.5 39 2 4 2 60 40 2 4 2 61.5 41 2 4 2 63 42 2 4 2 64.5 43 2 4 2 66 44 2 4 2 67.5 45 2 4 2 69 46 2 4 2 70.5 47 2 4 2 72 48 2 4 2 73.5 49 2 4 2 75 50 2 4 2 76.5 51 2 4 2 78 52 2 4 2 79.5 53 2 4 2 81 54 2 4 2 82.5 55 2 4 2 84 56 2 4 2 85.5 57 2 4 2 87 58 2 4 2 88.5 59 2 4 2 90 60 2 4 2 91.5 61 2 4 2 93 62 2 4 2 94.5 63 2 4 2 96 64 2 4 2 97.5 65 2 4 2 99 66 2 4 2 100.5 67 2 4 2 Envelope (mm) Sample x y z 1A 3 2 2 4 2 3A 4.5 3 2 6 3 3B 6 4 2 8 4 3C 7.5 5 2 10 5 3D 9 6 2 12 6 3E 10.5 7 2 14 7 3F 12 8 2 16 8 3G 13.5 9 2 18 9 3H 15 10 2 20 10 3I 16.5 11 2 22 11 3J 18 12 2 24 12 3K 19.5 13 2 26 13 3L 21 14 2 28 14 22.5 15 2 30 15 24 16 2 32 16 25.5 17 2 34 17 27 18 2 36 16 28.5 19 2 38 19 30 20 2 40 20 31.5 21 2 42 21 33 22 2 44 22 34.5 23 2 46 23 36 24 2 48 24 37.5 25 2 50 25 39 26 2 52 26 40.5 27 2 54 27 42 26 2 56 28 43.5 29 2 58 29 45 30 2 60 30 46.5 31 2 62 31 48 32 2 64 32 49.5 33 2 66 33 51 34 2 68 34 52.5 35 2 70 35 54 36 2 72 36 55.5 37 2 74 37 57 38 2 76 38 58.5 39 2 78 39 60 40 2 80 40 61.5 41 2 82 41 63 42 2 84 42 64.5 43 2 86 43 66 44 2 88 44 67.5 45 2 90 45 69 46 2 92 46 70.5 47 2 94 47 72 48 2 96 48 73.5 49 2 98 49 75 50 2 100 50 76.5 51 2 102 51 78 52 2 104 52 79.5 53 2 106 53 81 54 2 108 54 82.5 55 2 110 55 84 56 2 112 56 85.5 57 2 114 57 87 58 2 116 58 88.5 59 2 118 59 90 60 2 120 60 91.5 61 2 122 61 93 62 2 124 62 94.5 63 2 126 63 96 64 2 128 64 97.5 65 2 130 65 99 66 2 132 66 100.5 67 2 134 67 Optimal Envelope/Pitch Dimensions

[0064] Test Results

[0065] The results indicate that vacuum forming of the films tested to a draw depth of 2 mm for the shaded pitch and envelope sizes achieved remarkably superior results compared to films tested to a greater draw depth and with greater pitch and envelope sizes.

EXAMPLE 2

[0066] Further comparative tests were carried out as described below.

[0067] 1. Summary

[0068] During comparative tests, a hexagonal prism configuration (1A/A1) being utilised for the construction of a film according to the invention averaged a value of 36.30 dB, making it comparable to a commercially available pouch.

[0069] 2. Procedure

[0070] Samples were tested in a reverberation room (constructed from 215 mm brick that is internally plastered with a reinforced concrete floor and roof. The room had a volume of 300 m.sup.3 and was isolated by the use of resilient mountings and seals from the surrounding structure ensuring good acoustic isolation), and rustled at approximately one revolution per second.

[0071] Samples were rustled and once a consistent noise level was achieved, a measurement was taken for ten seconds, at a distance of one metre.

[0072] The samples were tested in accordance with BS EN ISO 3741:2010 Determination of sound power levels and sound energy levels of noise sources using sound pressurePrecision Methods for reverberation test rooms. In accordance with these tests, the sound power level or sound energy level of a noise source from sound pressure levels was measured in a reverberation test room. The sound power level (or, in the case of noise bursts or transient noise emission, the sound energy level) produced by the noise source, in frequency bands of width one-third-octave, is calculated using those measurements, including corrections to allow for any differences between the meteorological conditions at the time and place of the test and those corresponding to a reference characteristic impedance. Measurement and calculation procedures are given for both a direct method and a comparison method of determining the sound power level and the sound energy level.

[0073] In general, the frequency range of interest includes the one-third-octave bands with mid-band frequencies from 100 Hz to 10 000 Hz. The tests were not applicable to frequency ranges above the 10 000 Hz one-third-octave band.

[0074] The methods specified were suitable for all types of noise (steady, non-steady, fluctuating, isolated bursts of sound energy, etc.).

[0075] The noise source under test can be a device, machine, component or sub-assembly. The test are applicable to noise sources with a volume not greater than 2% of the volume of the reverberation test room. For a source with a volume greater than 2% of the volume of the test room, it is possible that the achievement of precise results is not feasible.

[0076] In accordance with the tests, a pole having a length of one meter was positioned between a sound level meter and the sample to be tested. The sound level meter was positioned on a first tripod, the pole was positioned on a second tripod and the sample was suspended adjacent an end of the pole distal to the sound level meter. This ensured that the sample was held at a consistent distance from the sound level meter.

[0077] 3. Results

[0078] The comparative test results are shown in the table below:

TABLE-US-00002 Average Description Lp Lp (dB & Sample Type x y z (dB) (dBA) dBA) Rank X1 Commercially n/a n/a n/a n/a n/a 44.60 44.80 44.70 11 Available A X2 Commercially n/a n/a n/a n/a n/a 34.90 33.80 34.35 2 Available B X3 Commercially n/a n/a n/a n/a n/a 42.80 42.40 42.60 10 Available C A Plain film having n/a n/a n/a n/a n/a 47.50 47.40 47.45 14 thickness of 63 um B Plain film having n/a n/a n/a n/a n/a 47.60 47.70 47.65 15 thickness of 75 um C Plain film having n/a n/a n/a n/a n/a 49.00 49.20 49.10 16 thickness of 100 um A1 Embodiment of 3 mm 2 mm 2 mm 4 mm 2 mm 38.40 32.70 35.55 3 the invention 1A Embodiment of 3 mm 2 mm 2 mm 4 mm 2 mm 38.90 35.20 37.05 5 the invention 1B Embodiment of 4.5 mm 3 mm 2 mm 4 mm 2 mm 47.40 46.20 46.80 13 the invention 1C Embodiment of 6 mm 4 mm 2 mm 4 mm 2 mm 46.00 45.30 45.65 12 the invention 3A Embodiment of 4.5 mm 3 mm 2 mm 6 mm 3 mm 43.70 41.40 42.55 9 the invention 3B Embodiment of 6 mm 4 mm 2 mm 8 mm 4 mm 35.90 30.40 33.15 1 the invention 3C Embodiment of 7.5 mm 5 mm 2 mm 10 mm 5 mm 40.40 34.70 37.55 7 the invention 3D Embodiment of 9 mm 6 mm 2 mm 12 mm 6 mm 38.30 34.60 36.45 4 the invention 3E Embodiment of 10.5 mm 7 mm 2 mm 14 mm 7 mm 44.00 40.20 42.10 8 the invention 3F Embodiment of 12 mm 8 mm 2 mm 16 mm 8 mm 44.10 40.10 42.10 8 the invention 3J Embodiment of 18 mm 12 mm 2 mm 24 mm 12 mm 38.70 36.20 37.45 6 the invention 3L Embodiment of 21 mm 14 mm 2 mm 28 mm 14 mm 42.90 42.20 42.55 9 the invention

[0079] 4. Conclusion

[0080] Based upon the results obtained in the comparative tests, the majority of the formed films of the invention demonstrated a lower dB level in the tests compared to films of standard manufactured ostomy pouches providing evidence that films of the invention can be used to manufacture quieter ostomy pouches.

[0081] The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the claims.