Ostomy pouch appliance

An ostomy appliance comprises an ostomy pouch having front wall, a rear wall with a stomal aperture, and an adhesive body fitment secured or securable around the stomal aperture. At least a portion of the adhesive of the body fitment is moldable. The front wall of the pouch comprises an access aperture providing access through the pouch interior for molding the adhesive. The access aperture is closable by a closure panel attachable over said access aperture by a peelable/resealable adhesive.

This application is a national stage of PCT/US2008/059628, filed Apr. 8, 2008, and claims priority to U.S. Provisional Patent Application No. 60/910,680 filed Apr. 9, 2007.

The present invention relates to an ostomy appliance comprising an ostomy pouch. In one non-limiting form, the invention relates to an appliance including a moldable adhesive. In another non-limiting form, the invention relates to a so-called one-piece appliance in which an adhesive body fitment is permanently attached to the pouch, although the invention may also be used with a two-piece appliance in which the adhesive body fitment is separably attachable to the pouch.

BACKGROUND OF THE INVENTION

Modern ostomy appliances are commonly attached to the body by means of an adhesive body fitment. The adhesive body fitments most commonly used are designed to have a predetermined, fixed shape. The wearer cuts the central opening of the adhesive fitment to match his or her stoma size and shape, using scissors to cut along guidance lines that are pre-printed on the adhesive for certain standard sizes.

U.S. Pat. No. 6,840,924 describes an improved ostomy appliance including a moldable adhesive, in which at least a portion of the adhesive can be manually shaped by the wearer, to provide a custom fit around the stoma. This alternative way of customizing the wafer offers the prospect of a better fit around the stoma than that obtainable by cutting along standard size guidelines. Achieving a good fit is desirable in order to reduce the exposure of the peristomal skin to stool exiting the stoma. Peristomal skin may be quite sensitive, and vulnerable to irritation or infection when contacted by stool. Stool exiting the stoma may contain digestive juices from the body, and such juices can also attack the peristomal skin resulting in excoriation. However, all stomas have different sizes and shapes. The advantage of a moldable adhesive as taught in U.S. Pat. No. 6,840,924 is that the user can mold the adhesive to closely match the exact size and shape of the stoma.

In a form in which the appliance of U.S. Pat. No. 6,840,924 is implemented as a two-piece ostomy appliance, the wearer is able to access the moldable adhesive on the non-body-contacting side, when the pouch is separated from the body fitment. This can enable the wearer to mold the adhesive with the body fitment in place around the stoma. However, when implemented as a one-piece appliance, the wearer can only access the moldable adhesive from the body-contacting side, and before the body fitment is secured to the body. This means that the shape and size of the aperture might not be as accurate as with a two-piece ostomy appliance.

WO-A-2004/084777 and WO-A-2006/035014 describe one-piece ostomy pouches in which an adhesive wafer is attached to the pouch using two different types of attachment extending in complementary first and second arcs that together extend completely around the stoma aperture. In the first arc, the wafer is permanently attached. In the second arc, the wafer is initially unattached or is releasably attachable. The second arc is said to permit the pouch to be folded away from the wafer in the region of the second arc, allowing access through the gap between the wafer and the pouch. This can enable access to facilitate cutting the adhesive, or fitting a separate sealing member, or removal and fitting of a separate disposable inner pouch. Some embodiments also feature an inspection hatch in the pouch wall to enable inspection of the stoma with the pouch in situ. The pouch is like a hybrid between a one-piece appliance (first arc of permanent attachment) and a two-piece appliance (second arc initially unattached or releasably attachable). However, unless the second arc is made very large, the appliance does not give complete unhindered access to the adhesive on all sides of the stoma aperture. It may be difficult for an elderly or non-dextrous person to use the appliance. Additionally, depending on the design, such a pouch construction might have vulnerabilities in the seal between the faceplate and the pouch at (i) the points at where the first and second arcs meet, and/or (ii) at the folding notches or creases of the stiffening ring, in view of the discontinuities which are inevitable at these points.

In devising the present invention, the inventors have appreciated that it would be desirable to provide an ostomy pouch appliance in which access to a moldable adhesive can be improved. More generally, it would be desirable to provide an ostomy pouch appliance in which access to the stomal area may be improved.

SUMMARY OF THE INVENTION

Broadly speaking, one aspect of the present invention provides an ostomy appliance comprising an ostomy pouch having a stomal aperture, and an adhesive body fitment secured or securable around the stomal aperture. At least a portion of the adhesive of the body fitment is moldable. The body fitment has an adhesive body-facing side for adhesively contacting the body, and a non-body-facing side that faces towards the pouch interior. The pouch comprises a closable opening configured for providing access through the pouch interior to the non-body-facing side of the adhesive.

With such an arrangement, the closable opening allows the ostomate (or some other person such as a nurse or other caregiver) to access the adhesive of the body fitment, even when the pouch is worn on the body.

The term “moldable” as used herein is intended to mean generally that the adhesive may be any of deformed or extruded or reshaped by hand. In a preferred form, the moldable adhesive portion is a moldable as a deformable adhesive sheet, meaning that the wafer retains generally sheet-like properties (in contrast to an extrudable form, for example), but the adhesive wafer may be molded by bending or flexing the adhesive wafer in the moldable region, or by rolling the adhesive wafer back on itself. Such a moldable wafer is especially configured for allowing the stomal aperture in the adhesive to be enlarged to a customized size and/or shape. The adhesive wafer may have a spring-back property such that the adhesive may tend to spring back partly towards its initial shape. Such a spring-back property may be useful for sealing around the stoma. Alternatively, the adhesive contact of the rolled back portion of the wafer may anchor the wafer stably in the molded shape without any, or with only limited, spring back.

In one embodiment, the adhesive wafer includes a constrained shape zone around the moldable region. The adhesive in the constrained zone may be integral with and/or of the same thickness as, the adhesive in the moldable region.

In one embodiment, the ostomy appliance is a one-piece item, in which the body fitment is permanently attached to the ostomy pouch. The term “permanently” as used herein is intended to mean that the body fitment is attached or attachable to the pouch in such a way that the fitment is not easily separable from the pouch without damage and/or is never intended to be separable from the pouch during normal use. Preferably, the body fitment is permanently secured around the entire circumference of the stomal aperture, to optimize the integrity of the seal between the body fitment and the ostomy pouch. With such a one-piece appliance, the closable opening allows access to the adhesive to enable the adhesive to be molded as easily and as accurately as with a two-piece appliance, either during initial fitting of the body fitment around the stoma, or once the appliance has been fitted to the body.

In an alternative embodiment, the ostomy appliance is a two-piece item, in which the body fitment is separably fastenable to the pouch (for example, by a releasable and/or resealable adhesive, or by a mechanical fastening). Even with a two-piece appliance, the closable opening may allow useful access to the adhesive, without having to remove the pouch from the body fitment.

The closable opening may take a variety of forms. A particularly preferred form is an aperture (referred to herein as an access aperture) in a wall of the pouch that faces the stoma aperture. For example, the access aperture may be in a front wall of the pouch, the stomal aperture being in a rear wall of the pouch. The access aperture preferably overlaps, at least partly, the stoma aperture. The access aperture may be approximately the same shape as the stomal aperture (e.g., round), but the access aperture may have a different shape as desired. The access aperture may be approximately the same size as the stomal aperture, or the access aperture may be larger than, or smaller than, the stoma aperture. The access aperture may be closed by a closure such as a sheet or panel of material fastenable around, or over, the access aperture. The closure may conveniently be fastenable by means of a peelable and resealable adhesive, that allows the adhesive bond to be peeled free, and remade, a plurality of times, so that the access aperture may be opened and reclosed. The adhesive may be carried on the pouch (e.g., on a flange faceplate surrounding the access aperture), or on the closure, or both. The closure may incorporate a flatus vent.

In other forms, the closable opening may comprise a flap portion of the pouch wall. Additionally or alternatively, the closable opening may be implemented in a seam of the pouch.

In another aspect, the invention provides an ostomy appliance comprising an ostomy pouch having a front wall and a rear wall, a stomal aperture formed in the rear wall, an access aperture formed in the front wall, and a closure for openably closing the access aperture. The closure incorporates a flatus vent and a deodorizing filter. In use, should the filter become soiled, the user can replace the filter by removing the closure, and fitting instead a replacement closure with a new filter.

The access aperture preferably overlaps, at least partly, the stoma aperture. The access aperture may be approximately the same shape and/or size as the stomal aperture, or the second aperture may be larger than, or smaller than, the stoma aperture, and/or of a different shape.

While features believed to be of special significance have been identified above and the appended claims, the Applicants claim protections for any novel feature or idea described herein and/or illustrated in the drawings, whether or not emphasis has been placed thereon.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring toFIGS. 1-4, a first embodiment illustrates a one-piece ostomy appliance10comprising an ostomy pouch12and a body fitment14permanently attached to the ostomy pouch12. The ostomy pouch12may be any of a colostomy pouch, a urostomy pouch and an ileostomy pouch.

The ostomy pouch12generally comprises a rear wall16and a front wall18. The front and rear walls16,18are made of flexible plastics film that is generally impermeable to liquid and gas. A suitable film includes, for example, a laminate of one or more layers of ethylene vinyl acetate (EVA), and one more layers of a gas barrier material, such as poly(vinylidene chloride) (PVDC). The walls16,18are welded together around a mutual periphery20. The ostomy pouch12optionally further comprises a deodorizing filter and vent (not shown) for deodorizing and venting flatus.

The rear wall16comprises a stomal aperture22around which the body fitment14is attached to the rear wall16. The body fitment14is attached, for example, by a suitable strong adhesive or weld in a region23surrounding the stomal aperture22. The permanent attachment extends around the entire periphery of the stomal aperture22, to provide continuous seal properties, and thus optimize the integrity of the seal between the ostomy pouch12and the body fitment14. The body fitment14includes a wafer of a skin compatible adhesive24. The adhesive24generally has a body-facing side26for facing towards and contacting the skin, and a non-body-facing side28that faces away from the skin, and instead faces towards the interior of the ostomy pouch12. In this embodiment, the adhesive24is of a moldable type, in which at least a portion of the adhesive24(such at least an inner peripheral region24a) is moldable or shapeable by manual manipulation, to enable the size and/or the shape of the central starter aperture30to be customized to match the size and/or shape of the ostomate's stoma32(FIG. 3). A close or snug fit around the stoma32is highly desirable, in order to protect the ostomate's peristomal skin34from irritation and excoriation by contact with stool exuding from the stoma32. The adhesive24may, for example, be of the type described in the aforementioned U.S. Pat. No. 6,840,924. Such an adhesive24is configured in a moldable wafer form to enable the adhesive to be shaped while retaining a sheet-like form. The adhesive24comprises a laminate structure including (i) plural layers of adhesive, and/or (ii) at least one layer of adhesive reinforced by at least one layer of plastics film. The aperture in the adhesive24can be expanded to a customized shape and/or size by bending and rolling the adhesive24back on itself around the aperture, as illustrated inFIG. 3. Alternatively, the adhesive24may be of a flowable or extrudable mass type (not shown). In either case, in the present embodiment, the inner peripheral region24aof the adhesive24is integral with a constrained region24bof the same adhesive24, that has a more constrained shape. The two regions24a,24boptionally have the same thickness. The constrained region24bmay be defined by backing or reinforcing member25. The member25may be flexible, or it may be stiffer than the adhesive24. The member25may be generally planar (e.g., a planar ring, as illustrated), or it may be non-planar, e.g., flared or frusto-conical.

The ostomy pouch12comprises a closable opening (depicted generally at36) for enabling a person (for example, the ostomate, or a nurse or other caregiver) to access the adhesive24from the non-body-facing side28, through the interior of the ostomy pouch12. The closable opening36is distinct from the stomal aperture22. Access from the non-body-facing side28is highly advantageous, because it allows the person to manipulate the adhesive24(or at least the inner peripheral region24a) (i) prior to fitting of the ostomy appliance10to the body, e.g., during preparation of the ostomy pouch12; and/or (ii) during the fitting of the ostomy appliance10to the body to verify a good fit, and allow minor adjustments of the adhesive24as necessary, and/or (ii) after the ostomy appliance10has been fitted to the body. This is a highly significant advantage compared to a conventional one-piece ostomy appliance, in which access from the non-body-facing side28is impossible because, in a conventional one-piece ostomy appliance, the non-body-facing side28is permanently covered by the pouch wall material.

In the illustrated embodiment, the closable opening36is provided in the form of an access aperture38in the front wall18of the ostomy pouch12. The access aperture38is, for example, generally the same shape as the stomal aperture22, such as round. However, the access aperture38may have a different shape, if desired. The access aperture38is, for example, of approximately the same size as the stomal aperture22(as indicated by the broken lines40). However, the access aperture38may be smaller or larger, as desired. The access aperture38at least partly overlaps the stomal aperture22, for ease of access to the stomal region and the adhesive24.

The ostomy appliance10further comprises an access closure42for openably closing the access aperture38. In the present embodiment, the access closure42generally comprises a sheet or panel44that is attachable over the access aperture38to seal the access aperture38closed. The panel44is attachable by means of a resealable adhesive that allows the adhesive bond to be peeled apart, and remade, a plurality of times. In order to protect the front wall18from risk of damage caused by peeling the panel44open, the ostomy pouch12optionally comprises a flange or faceplate46on the front wall18for contacting the panel44. The resealable adhesive may be carried on the faceplate46and/or on the panel44. In the illustrated embodiment, the adhesive is carried on the panel44, and the faceplate46is made of a non-adhesive, generally tough but flexible plastics film. The faceplate46is larger than the panel44, to avoid any adhesion complications should the panel44be slightly out of position or alignment. The panel44comprises a layer of foam material48carrying the adhesive, and a layer49of gas impermeable plastics. The impermeable layer49is dimensioned to be larger than the access aperture38, but smaller than the overall size of the foam material48, to leave a peripheral circumferential (e.g., annular) region48aof the foam material48exposed. The region48ais the adhesive region of the panel44for contacting the faceplate46.

Also in the present embodiment, the panel44is attached captively to the ostomy pouch12, for example, by a living hinge50between the panel44and the ostomy pouch12. The living hinge50is formed by an extension of the flexible foam material48attached to the front wall18or to the faceplate46. Alternatively, such a living hinge50could be formed by an extension of the faceplate46or a flap (not shown) attached to the front wall18. The living hinge50is formed at the bottom edge of the panel44when the pouch is viewed in a normally upright orientation, so that the panel44will fold downwardly in use, and thereby avoiding the panel44closing accidentally under gravity if the panel44were to fold open in a different direction. The panel44further comprises a tab52generally opposite the living hinge50, by which the panel44can be grasped for peeling the panel44open by a downward movement.

The ostomy appliance10may be supplied to the user in a sealed package, depicted schematically at51. The package51may be sterilized and/or hermetically sealed. In the form supplied to the user, the body-fitment14is permanently sealed to the ostomy pouch12all around the periphery of the stoma aperture22in the ostomy pouch12. Equivalent packaging51may be used with other embodiments, even if not illustrated explicitly in the drawings to avoid clutter. One or removable release sheets (not shown) may be provided initially protecting the adhesive surface on the body-facing side26of the body fitment14, and/or the adhesive surface on the non-body-facing side28that faces the pouch interior.

Referring toFIGS. 1 and 2, in order to prepare the ostomy appliance10prior to fitting to an ostomate, the panel44is peeled down to open the access aperture38, and expose the non-body-facing side28of the adhesive24through the interior of the ostomy pouch12. A person may insert his or her fingers (as indicated at53) through the access aperture38, to manipulate the adhesive24by folding or rolling the inner peripheral region24atowards the pouch interior. The ability to access the adhesive24from the non-body-facing side28enables the person to accurately mold the adhesive24to precisely fit the unique size and shape of the stoma32, thereby obtaining an excellent seal around the stoma32. Even once the ostomy appliance10is in its worn position, the person can still access the adhesive24to make minor adjustments to the molded shape, and achieve an optimum fit.

The ostomy pouch12is then fitted to the peristomal skin, such that the stoma32enters the stomal aperture22molded in the adhesive24. The fit of the adhesive24can be inspected through the access aperture38.

Thereafter, (FIGS. 3 and 4) the panel44is resealed in order to close the access aperture38. The adhesive bond of the access panel44is sufficiently strong to ensure that the panel44remains firmly closed in use of the ostomy pouch12. The impermeable layer49blocks leakage of flatus through the panel44, thereby ensuring that the closable opening36does not compromise the integrity of the ostomy pouch12in use.

The panel44also permits the ostomate, or another person such a nurse or other caregiver, to access the stoma32or the adhesive24even while the ostomy appliance10is being worn. The panel44can be peeled open at any time desired, for example, to effect minor adjustments to the molded shape of the adhesive24, or for inspection or cleaning of the stoma32, or to administer medicaments directly on to the stoma tissue. Once the process has been completed, the panel44is reclosed to continue normal use of the ostomy pouch12. Release material may be provided on the inside of the ostomy pouch12and/or on the inside of the panel44to help prevent the panel44from sticking to the inside surface of the moldable adhesive24.

FIGS. 5 and 6illustrate a second embodiment of ostomy appliance10and ostomy pouch12. The second embodiment is similar to the first embodiment except in the detail of the access aperture38and access closure42. In the second embodiment, the adhesive is carried by the faceplate46. The faceplate46is constructed of the adhesive foam material48as used in the closure panel44of the first embodiment. The foam material48defines a generally annular adhesive region48a, and an optional, non-adhesive grip tab54. The access closure42comprises a panel44of a generally tough yet flexible plastics film optionally provided with a grip tab56, for peeling the panel44from the faceplate46.

In the second embodiment, the panel44is illustrated to be distinct from the pouch12, although, if desired, the panel44could be attached to the ostomy pouch12captively, as in the first embodiment.

FIG. 7illustrates a third embodiment, which is a modification of the access closure42usable in the first or second embodiment. In the third embodiment, a flatus vent assembly (identified generally by the numeral60) is integrated into the access closure42. Various configurations of flatus vent assembly60are possible. In the illustrated embodiment, the flatus vent assembly60generally comprises one or more vent apertures62in the access closure42, a deodorizing filter64communicating with the vent aperture62for deodorizing flatus exiting through the vent aperture62, and a protection stage66for protecting the deodorizing filter64from contact by solid and liquid stool. The protection stage66may be integrated into the deodorizing filter64and/or may itself comprise one or more gas-permeable barrier components (not shown). Although the flatus vent assembly60is illustrated generally to be on the side of the access closure42that faces away from pouch interior, one or more (or all) components of the flatus vent assembly may be placed on the inner face of the access closure42.

Integrating the flatus vent assembly60into the access closure42may be advantageous because:(i) from a manufacturing view, the flatus vent assembly60can be made separately from the ostomy pouch12, as a smaller flatus vent assembly60, leading to easier production and/or production at a manufacturing different location or using different plant; and(ii) from a user's view, particularly with the second embodiment, the arrangement allows replacement of a used or soiled flatus vent assembly60simply by using a new access closure42. Thus, should the deodorizing filter64become soiled, or blocked, or otherwise stop functioning prematurely, the user may be able to discard the access closure42with the malfunctioning deodorizing filter64, and replace it by a fresh access closure42with a fresh deodorizing filter64. The user may therefore continue wearing the ostomy appliance10for its full wear-life.

FIG. 8illustrates a fourth embodiment of the invention. The main difference in the fifth embodiment is that the ostomy appliance10is a two-piece appliance. The adhesive body fitment14is releasably fastenable to the ostomy pouch12by means of an ostomy coupling80. The ostomy coupling80may be a mechanical type (e.g., using inter-engaging locking rings) or an adhesive type (e.g., using a peelable and resealable adhesive). The ostomy coupling80permits the ostomy pouch12to be completely detached from the body fitment14, so that a replacement pouch may be fitted when desired. The access aperture38and access closure42of the fourth embodiment may be similar to those of any preceding embodiment, but are especially advantageous when using the third embodiment.

As explained above, even with a two-piece appliance as in the fourth embodiment, the invention may enable the ostomate or another person (such as a nurse or other caregiver) to have access to the stoma32even while the ostomy appliance10is worn on the body. When this embodiment is combined with the third embodiment, replacement of the flatus vent assembly60is also facilitated without having to replace the ostomy pouch12itself.

It will be appreciated that the foregoing description is illustrative of preferred forms of the invention, and that many modifications, improvements and equivalents are possible that are within the scope of the claimed coverage of the invention.