OSTOMY BAG

Abstract

The invention provides an ostomy bag assembly comprising outer (2) and inner (4) bags secured to one side of an adhesive flange (6); the adhesive flange (6) having means defining an orifice to enable bodily waste from a stomal opening to be received by the inner bag; wherein the adhesive flange is of laminar construction and comprises, in sequence, from a body-contacting surface outwards: (a) a bioadhesive layer (10) for securing the flange to a body surface of a patient about the stomal opening; (b) a first polymeric support layer (8) attached to the bioadhesive layer (a); (c) a heat sealable layer (16) having a heat sealable adhesive surface which releasably bonds the heat sealable layer to the first polymeric support surface; (d) a second polymeric support layer (14) bonded to the heat sealable layer; (e) a weldable polymeric layer (18) to which the inner and outer bags are attached, the weldable polymeric layer being bonded to the second polymeric support layer;
the adhesive flange having an annular channel (20) which surrounds the means defining the orifice and extends through layers (c), (d) and (e) so as to form radially inner (22) and outer (24) attachment zones separated by the annular channel (20), the inner bag (4) being attached to the radially inner attachment zone (22) and outer bag (2) being attached to the radially outer attachment zone (24);
and wherein the inner and outer bags (4),(2), together with attached portions of layers (c), (d) and (e) can each be peeled away from the first polymeric support layer (b).

Also provided by the invention are adhesive flange blanks from which the ostomy bag assemblies can be manufactured, as well as methods for the manufacture of the ostomy bag assemblies and the adhesive flange blanks.

Claims

1. An ostomy bag assembly comprising outer and inner bags secured to one side of an adhesive flange; the adhesive flange having means defining an orifice to enable bodily waste from a stomal opening to be received by the inner bag; wherein the adhesive flange is of laminar construction and comprises, in sequence, from a body-contacting surface outwards: (a) a bioadhesive layer for securing the flange to a body surface of a patient about the stomal opening; (b) a first polymeric support layer attached to the bioadhesive layer (a); (c) a heat sealable layer having a heat sealable adhesive surface which releasably bonds the heat sealable layer to the first polymeric support surface; (d) a second polymeric support layer bonded to the heat sealable layer; (e) a weldable polymeric layer to which the inner and outer bags are attached, the weldable polymeric layer being bonded to the second polymeric support layer; the adhesive flange having an annular channel which surrounds the means defining the orifice and extends through layers (c), (d) and (e) so as to form radially inner and outer attachment zones separated by the annular channel, the inner bag being attached to the radially inner attachment zone and the outer bag being attached to the radially outer attachment zone; and wherein the inner and outer bags, together with attached portions of layers (c), (d) and (e) can each be peeled away from the first polymeric support layer (b).

2. The ostomy bag assembly according to claim 1, wherein the first polymeric support layer (b) comprises a layer of polyurethane or polyamide film.

3. The ostomy bag assembly according to claim 1, wherein the heat sealable layer (c) has a heat sealable adhesive surface comprising an ethylene vinyl acetate copolymer adhesive.

4. ostomy bag assembly according claim 1, wherein the second polymeric support layer (d) is formed from a polyamide.

5. The ostomy bag assembly according to claim 1, wherein the weldable polymeric layer (e) is formed from an ethylene polymer or copolymer.

6. The ostomy bag assembly according to claim 5, wherein the weldable polymeric layer (e) is formed from ethylene vinyl acetate copolymer.

7. The ostomy bag assembly according to claim 1, wherein the annular channel has been formed by means of die cutting through the layers (c), (d) and (e).

8. The ostomy bag assembly according to claim 1, wherein the annular channel is circular or elliptical in plan.

9. (canceled)

10. A method for manufacturing an ostomy bag assembly as defined in claim 1, wherein the method comprises: (i) providing a wafer comprising the first polymeric support layer (b), the bioadhesive layer (a) and a removable protective layer (f) for the bioadhesive; (ii) die cutting a laminate blank comprising the heat sealable layer (c), the second polymeric support layer (d) and the weldable polymeric layer (e) from a web of coextruded polymeric layers; (iii) placing the laminate blank on to the wafer; (iv) heat sealing the laminate blank to the wafer to form an adhesive flange blank; (v) die cutting the adhesive flange blank through layers (c), (d) and (e) but not the polymeric support layer (b) to give radially inner and outer attachment zones separated by the die cut; (vi) bringing into contact with the die cut adhesive flange a web of a material from which a panel of the outer bag is to be formed and welding the said web to the weldable polymeric layer of the radially outer attachment zone; (vii) placing the inner bag on the adhesive flange, and bonding the inner bag to the radially inner attachment zone of the adhesive flange; (viii) bringing into contact with the said web a further web of a material from which another panel of the outer bag is to be formed and outline welding the webs together so that they form the outer bag and enclose the inner bag; and thereafter (ix) cutting the webs to release the ostomy bag assembly.

11. The process according to claim 10 wherein placing the inner bag on the adhesive flange, and bonding the inner bag to the radially inner attachment zone of the adhesive flange comprises the inner bag being adhesively bonded to the adhesive flange.

12. (canceled)

13. An adhesive flange for use in manufacturing an ostomy bag assembly as defined in claim 1, wherein the adhesive flange is of laminar construction and comprises, in sequence, from a body-contacting surface outwards: (a) a bioadhesive layer for securing the flange to a body surface of a patient about the stomal opening; (b) a first polymeric support layer attached to the bioadhesive layer (a); (c) a heat sealable layer having a heat sealable adhesive surface which releasably bonds the heat sealable layer to the first polymeric support surface; (d) a second polymeric support layer bonded to the heat sealable layer; (e) a weldable polymeric layer to which inner and outer bags can be attached, the weldable polymeric layer being bonded to the second polymeric support layer; the adhesive flange having an annular channel which surrounds the means defining the orifice and extends through layers (c), (d) and (e) so as to form radially inner and outer attachment zones separated by the annular channel, the radially inner attachment zone being attachable to an inner bag and the radially outer attachment zone being attachable to an outer bag.

14. The method of manufacturing an adhesive flange as defined in claim 13, which method comprises: (i) providing a wafer comprising the first polymeric support layer (b), the bioadhesive layer (a) and a removable protective layer (f) for the bioadhesive; (ii) die cutting a laminate blank comprising the heat sealable layer (c), the second polymeric support layer (d) and the weldable polymeric layer (e) from a web of coextruded polymeric layers; (iii) placing the laminate blank on to the wafer; (iv) heat sealing the laminate blank to the wafer to form an adhesive flange blank; and (v) die cutting the adhesive flange blank through layers (c), (d) and (e) but not the polymeric support layer (b) to give radially inner and outer attachment zones separated by the die cut.

15. The ostomy bag assembly of claim 1, wherein the first polymeric support layer (b) comprises a layer of polyurethane or polyamide film and the heat sealable layer (c) has a heat sealable adhesive surface comprising an ethylene vinyl acetate copolymer adhesive.

16. The ostomy bag assembly of claim 1, wherein the first polymeric support layer (b) comprises a layer of polyurethane or polyamide film, the heat sealable layer (c) has a heat sealable adhesive surface comprising an ethylene vinyl acetate copolymer adhesive, and the second polymeric support layer (d) is formed from a polyamide.

17. The ostomy bag assembly of claim 1, wherein the first polymeric support layer (b) comprises a layer of polyurethane or polyamide film, the heat sealable layer (c) has a heat sealable adhesive surface comprising an ethylene vinyl acetate copolymer adhesive, the second polymeric support layer (d) is formed from a polyamide, and the weldable polymeric layer (e) is formed from an ethylene polymer or copolymer.

18. The ostomy bag assembly of claim 1, wherein the annular channel has been formed by means of die cutting through the layers (c), (d) and (e) and the annular channel is circular or elliptical in plan.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0072] FIG. 1 is a schematic sectional view of an ostomy bag assembly according to one embodiment of the invention.

[0073] FIG. 2 is an enlarged view of the region A in FIG. 1 showing the layer structure of the ostomy bag assembly in the region of the attachment of the inner bag.

[0074] FIG. 3 is a schematic sectional view, not to scale, showing the layer structure of the ostomy bag assembly of FIGS. 1 and 2.

[0075] FIG. 4 is a plan view of an adhesive flange forming part of the ostomy bag assembly of FIGS. 1, 2 and 3.

DETAILED DESCRIPTION OF THE INVENTION

[0076] The invention will now be described in more detail, but not limited, by reference to the specific embodiment illustrated in the drawings.

[0077] Referring now to the drawings, FIGS. 1 to 4 show an ostomy bag assembly according to a first embodiment of the invention.

[0078] The ostomy bag assembly of FIGS. 1 to 4 comprises an outer bag 2 and an inner bag 4 attached to an adhesive flange 6.

[0079] The adhesive flange 6 comprises a polymeric backing film (first polymeric support layer) 8 which, in this embodiment is formed from polyurethane and has a thickness of approximately 30 m. Supported on the backing film 8 is a layer 10, approximately 0.6 mm to 0.9 mm thick, of a hydrocolloid adhesive. The hydrocolloid adhesive, which may be of conventional type, serves to secure the ostomy bag to the body of a patient. A siliconised paper release layer 12 covers the hydrocolloid adhesive layer and protects the adhesive layer against damage and/or drying out prior to use of the bag.

[0080] The layer structure of the adhesive flange can be seen in more detail in FIGS. 2 and 3. Thus, attached to the polyurethane backing film is co-extruded multilayer polymeric material which, in the particular embodiment illustrated, consists of a central layer 14 of Surlyn sandwiched between two layers 16 and 18 of ethylene vinyl acetate (EVA). One of the EVA layers (18) is present in the form of a film and the other (16) is present as a layer of an EVA copolymer adhesive emulsion. The EVA adhesive-coated co-extruded multilayer polymeric material can be, for example, PerfecSeal coated PerfecFlex medical forming film available from Perfecseal Limited of Londonderry, UK.

[0081] With reference to the claims and statements of invention herein, the siliconised release paper 12, hydrocolloid layer 10, polyurethane backing film 8, EVA adhesive emulsion 16, Surlyn layer 14 and EVA layer 18 correspond to layers (f), (a), (b), (c), (d) and (e) respectively.

[0082] The EVA adhesive emulsion layer 16 is bonded to the polyurethane backing film 8 by applying heat with an annular heat sealing tool at a temperature of 120 C. to 160 C. for a period of about 2 to 5 seconds. The EVA adhesive functions as a hot melt adhesive that forms a bond which, whilst easily strong enough to withstand any forces to which it is subjected during use, can subsequently be peeled apart using reasonable manual force.

[0083] During manufacture of the adhesive flange, a die cutting tool is used to create an annular kiss cut 20 which extends through the EVA layer 18, the Surlyn layer 14 and the EVA adhesive emulsion layer 16 but not through the polyurethane backing film 8. The annular kiss cut, which extends in a circle around the flange, serves to divide the bag-side surface of the adhesive flange into concentric regions defining a radially inner attachment zone 22 and a radially outer attachment zone 24.

[0084] Extending outwardly from the outer attachment zone is a tab 36 which acts as primary release tab to facilitate the removal of the outer bag after use. A skip cut 38, which also extends through the EVA layer 18, the Surlyn layer 14 and the EVA adhesive emulsion layer 16 but not through the polyurethane backing film 8, defines a secondary release tab 40 that can be used to assist removal of the inner bag after use.

[0085] The outer bag 2 is firmly bonded to the EVA layer 18 in the radially outer attachment zone 24 by welding, for example by Rf welding. This ensures a secure bond between annular bonding element and outer bag which cannot be disrupted without tearing the fabric of the outer bag.

[0086] The inner bag 4 is provided with a PVC mounting ring 26 which surrounds the opening 28 in the inner bag. The PVC ring is firmly bonded to the panel 30 of the inner bag by means of a layer 32 of cyanoacrylate adhesive. The strength of the bond is such that the panel of bag material cannot readily be removed from the PVC ring without damaging the structure of the bag. The PVC ring is bonded to the EVA layer 18 in the radially inner attachment zone by means of a layer 34 of rubber based adhesive. Adhesive layers 32 and 34 are not shown separately in FIG. 3 but form part of the element identified in FIG. 3 by the numeral 26.

[0087] The outer bag 2 in this embodiment can be formed from materials well known for the construction of ostomy bags. Thus, for example, it can be formed from a tough, flexible, transparent, waterproof material such as polyvinyl dichloride (PVDC), ethylene vinyl acetate (EVA), related materials and combinations thereof in known fashion, one particular material being the EVA/PVDC/EVA film available from Sealed Air of Saddle Brook, N.J., US under the trade name Cryovac MF514.

[0088] In the embodiment shown, the outer bag is formed from a pair of panels 2a and 2b formed from the flexible waterproof material, one panel 2a being cut so as to form an opening which is aligned with the opening 28 in the inner bag. The inner edge of the panel 2a, i.e. the region surrounding the opening, is welded to the radially outer attachment zone 24. The other panel 2b has the same outer periphery as panel 2a, but no opening. The two panels 2a and 2b are secured together around their respective peripheries by welding, (for example Rf welding) or by means of adhesive. Attached to the panels 2a and 2b by welding around their respective peripheries are panels (not shown) of a fibrous non-woven material such as a non-woven polyethylene fabric which serve as a comfort layer, providing a warmer and less harsh feeling against the skin of the patient.

[0089] The polymeric materials from which the panels 2a and 2b are formed act as a barrier to gases, and in particular flatus gases. Therefore, in order to prevent ballooning of the ostomy bag through the build up of flatus gases inside the bag, the outer bag is usually provided with a small opening (not shown) covered by a flatus filter (also not shown) which is welded to both the panel 2b and the comfort layer.

[0090] The inner bag 4 can be formed from two pairs of panels of polymeric material, welded together along their peripheries wherein the inner pair of panels are formed from a mechanically tough warm water soluble grade of polyvinyl alcohol film, for example LA40 film available from Aichello, Japan, and the outer pair of panels are formed from a fibrous non-woven tissue formed from cold water soluble polyvinyl alcohol fibres and rayon fibres, which disintegrates in water. However, in the drawings, for simplicity, only a single pair of panels is shown.

[0091] In use, faecal material from a stomal opening passes through the opening in the flange and the opening 28 in the inner bag into the interior of the inner bag 4. When the inner bag 4 is full, the outer bag 2 together with its attached portions of the EVA layer 18, the Surlyn layer 14 and the EVA adhesive emulsion layer 16, can be peeled away from the polyurethane backing film 8. The remaining part of the flange and the inner bag may then be disposed of by flushing down a WC and the outer bag disposed of through normal domestic waste channels. A new assembly of inner and outer bag and adhesive flange may then be applied to the patient.

[0092] Because the inner bag is formed from materials that are soluble or disintegratable in water, and the hydrocolloid adhesive of the flange is also soluble or erodible in water, the sub-assembly of flange and inner bag disintegrates during flushing and subsequent passage through waste pipes leaving as a residue only the thin polyurethane backing film 8 and any insoluble fibres in the material from which the inner bag is formed.

[0093] However, as an alternative, the inner bag and its attached portions of the EVA layer 18, the Surlyn layer 14 and the EVA adhesive emulsion layer 16, can also be peeled away from the polyurethane backing film 8 so that the inner bag 4 and the remainder of the flange can be disposed of separately. This method of disposal may be preferred where there are more stringent restrictions on the materials that can be flushed down a WC, for example because the construction of the waste pipe is such that it is more liable to become blocked, or where the disposal of non-water dispersible materials is forbidden or impractical.

[0094] Thus, one advantage of the ostomy bag assembly of the invention is that it provides the user with greater flexibility in the manner in which the assembly is disposed of after use.

[0095] Another advantage of the ostomy bag assembly of the invention is that it can be manufactured by a largely automated production process requiring relatively little manual intervention.

[0096] A typical manufacturing process for the ostomy bag assemblies is described below.

[0097] Wafers or blanks which will become layers (f), (a) and (b) of the adhesive flange 6 are die cut from sheets of a trilaminar material consisting of the polyurethane backing film 8, hydrocolloid adhesive 10 and siliconised paper 12. The wafers can be prepared off site or manufactured in situ. The wafers are loaded into a magazine and are transferred on a rotating carousel to a cutting station where a datum hole is die cut in the centre of the wafer. The hole serves as the datum point for the alignment of the various components of the ostomy bag assembly later in the manufacturing process.

[0098] In a separate operation, a web of a coextruded multilayer film consisting of Surlyn sandwiched between two layers of ethylene vinylacetate (EVA), one of which is in the form of an EVA copolymer adhesive emulsion, is die cut to form discs of material that will become layers (c), (d) and (e) of the adhesive flange.

[0099] Each disc is then automatically conveyed to another work station where it is placed over an adhesive flange wafer so that the disc is concentric with the datum hole in the wafer. Heat and pressure are then applied to the disc to form a heat seal between the EVA copolymer adhesive emulsion layer of the disc and the polyurethane backing film 8 of the wafer. At the same time, or shortly afterwards, an annular channel or kiss cut is cut into the disc by means of a die cutter so that the kiss cut extends through the EVA and Surlyn layers 18, 14 and 16 but not through the polyurethane backing film 8.

[0100] Once the heat seal has been created, the sub-assembly of disc and adhesive flange wafer, which together form an adhesive flange blank constituting layers (f), (a), (b), (c), (d) and (e) of the adhesive flange, is removed, turned over and placed on a tray to cool with the layer (e) facing down so as to prevent curling.

[0101] After cooling, the die cut adhesive flange blanks are loaded into a magazine with the EVA layer 18 facing up and transferred to a separate machine for creating the ostomy bags.

[0102] In a first step in the creation of the ostomy bags, a first web of a non-woven fabric (from which a comfort panel (not shown) is made) is die cut to form a series of circular holes. A second web, which is formed from an EVA/PVDC/EVA film (which will become panel 2a) is then die cut with a series of holes of a smaller diameter than the holes in the first web. The first and second webs are then secured together by means of peripheral tack welds.

[0103] The adhesive flanges are then transferred from their magazine to a welding station where they are successively welded to the second web so that each sub-assembly surrounds one of the holes in the web.

[0104] The first and second webs carrying the adhesive flange blanks pass through a further processing station where pre-formed inner bags are adhesively bonded to the flange blanks. Each inner bag has a strengthening ring of PVC surrounding its opening, the PVC mounting ring being secured to the inner bag panel by means of a cyanoacrylate adhesive. The PVC ring is pre-coated with a rubber adhesive and is bonded to the flange blank with the application of pressure and optionally heat. In the present example, PVC rings coated with a rubber based adhesive (product code F277) were obtained from Avery Dennison and were then used in the manufacture of the inner bags.

[0105] At a separate filter welding station, a third web of material, from which the panel 2b will be formed, and a fourth web of material, from which a comfort panel (not shown) will be formed, are brought together and a filter is welded to the surface of the third web. The welding operation is carried out for a period of time sufficient to ensure that the fourth web is also welded to the third web in the region of the filter. The region over the filter where the third and fourth webs are welded together is then perforated to form an exit hole for flatus gases passing through the filter.

[0106] Once the filter has been affixed, the first, second, third and fourth webs are passed through another welding station where the four webs are outline welded together (the outline of the weld defining the shape of the ostomy bag). The webs are then cut around the outer edge of the outline to release the completed ostomy bag assembly from the webs. The completed ostomy bag assemblies may then be inspected and packed.

[0107] During the assembly of the ostomy bag, a further and optional cutting step may be employed in which the datum hole is enlarged to a size suitable for fitting about a stomal opening. During this step, differently sized cutters may be used for different batches thereby enabling the creation of a range of ostomy bags with different sizes of opening.

EQUIVALENTS

[0108] It will readily be apparent that numerous modifications and alterations may be made to the specific embodiments of the invention described above without departing from the principles underlying the invention. All such modifications and alterations are intended to be embraced by this application.