Patent Publication Number: US-2010114044-A1

Title: Adhesive body fitment for ostomy appliane

Description:
The present invention relates to an adhesive body fitment for an ostomy appliance. In particular, the invention relates to a fitment including a moldable adhesive. This fitment may be utilized in a one-piece appliance in which the adhesive body fitment is permanently attached to the appliance, or a two-piece appliance in which the adhesive body fitment is releasably attachable to the appliance. 
     BACKGROUND TO THE INVENTION 
     The adhesive body fitments most commonly used for attaching ostomy appliances to the body are designed to have a generally fixed shape that is predetermined by manufacture. The adhesive body fitment has a central opening that can be cut to enlarge the opening to a desired size to fit a wearer&#39;s stoma. The adhesive is pre-printed with concentric guidance lines around the opening for certain standard stoma sizes, and the user uses scissors to cut along the appropriate line to enlarge the opening to the selected size. 
     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 molded by the wearer, to provide a customized size and shape of opening. The adhesive, initially in a planar configuration, is molded by rolling back the inner peripheral edge of the stoma aperture on the side facing away from the body of the wearer. 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, 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 his or her 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 shape the adhesive by rolling back the adhesive on the non-body-contacting side. 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. 
     Another example of an adhesive body fitment employing a moldable adhesive is described in U.S. Published Application No. 2006/0184145. This specification teaches an initially planar adhesive wafer that is moldable by rolling back the inner rim of the adhesive away from the body-facing side of the wafer, in a manner almost no different from the aforementioned U.S. Pat. No. 6,840,924. A further example is illustrated in U.S. Pat. No. 6,332,879. 
     In devising the present invention, the inventors have appreciated that it would be desirable to enhance the ease of use of an ostomy appliance including a moldable adhesive, especially but not exclusively, a one-piece appliance. 
     SUMMARY OF THE INVENTION 
     One aspect of the present invention provides an adhesive body fitment for attaching an ostomy appliance to a wearer&#39;s body. The body fitment comprises an adhesive wafer including a moldable region having a starter hole therethrough for allowing a user to manually mold a stomal aperture in the moldable region. The inner peripheral region of the adhesive bordering the hole is preshaped to have, prior to molding by the user, a non-planar configuration. The non-planar configuration may enable the user more easily to begin molding the adhesive into a desired form. The non-planar configuration may present the inner edge of the adhesive bordering the hole, offset towards one side of the wafer. 
     In one form, the non-planar configuration is a bulge or protruberance away from the body-facing side of the wafer. The adhesive at the starter hole is bent to be in front of (i) the rearmost surface of the adhesive and/or (ii) a generally planar portion of the adhesive at the outer periphery of the adhesive. Such a configuration of the moldable adhesive at, or near, the starter hole can facilitate rolling of the adhesive in a frontward direction away from the body-facing side of the wafer. The configuration pre-disposes the adhesive to be more easily molded than, for example, were the adhesive to have a purely planar shape. The invention is especially suitable for use in a one-piece ostomy appliance in which access to the adhesive, to fold back the adhesive away from the body-facing side, is restricted. However, the invention also finds use in a two-piece appliance, where ease of molding is also enhanced, for example for non-dextrous or elderly users. 
     Additionally or alternatively, the wafer may further comprise a release device that supports the shape of the non-planar configuration. The release device covers and/or protects the adhesive surface of the wafer, and is intended to be removed from the adhesive before the wafer is placed against the skin. The release device includes a generally stiff or fixed-shape support that defines the non-planar configuration of the moldable adhesive. 
     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 moldable as a deformable adhesive sheet, meaning that the wafer retains generally sheet-like properties (in contrast to an extrudable form, for example), and 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 optionally 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. 
     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. 
     While features believed to be of special significance have been identified above claim protection may be sought for any patentable feature described herein and/or illustrated in the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic cross-sectional view through a first embodiment of ostomy pouch, in the form of a one-piece appliance. 
         FIG. 2  is a schematic perspective view of the release member from the pouch of  FIG. 1 . 
         FIG. 3  is a schematic cross-sectional view showing use of the first embodiment when the release member is removed. 
         FIG. 4  is a schematic cross-sectional view through a second embodiment of ostomy pouch in the form of a one-piece appliance having a shape-defining member. 
         FIG. 5  is a schematic cross-sectional view through a third embodiment of ostomy pouch in the form of a two-piece appliance. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to  FIGS. 1 and 2 , a first embodiment illustrates a one-piece ostomy appliance  10  comprising an ostomy pouch  12  and a body fitment  14  permanently attached to the ostomy pouch  12 . The ostomy pouch  12  may be any of a colostomy pouch, a urostomy pouch and an ileostomy pouch. The ostomy appliance  10  represents ostomy equipment that is optionally supplied to a user in a package  15 . The package  15  can take various forms, for example, a sealed bag or a blister pack. In the present embodiment, the package  15  is sterile inside, and is hermitically sealed in a closed condition. 
     The ostomy pouch  12  includes a rear wall  16  and a front wall  18 . The front and rear walls  16 ,  18  are 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 walls  16  and  18  are welded together around a mutual periphery  20 . 
     The rear wall  16  has a stomal aperture  22  around which the body fitment  14  is attached to the rear wall  16 . The body fitment  14  is attached, for example, by a suitable strong adhesive or weld in a region  23  surrounding the stomal aperture  22 . The body fitment  14  includes a wafer of a skin compatible adhesive  24 . The adhesive  24  generally has a body-facing side  26  for facing towards and contacting the skin, and a non-body-facing side  28  that faces away from the skin, and instead faces towards the interior of the ostomy pouch  12 . In this embodiment, the adhesive  24  is of a moldable type, in which at least a portion of the adhesive  24  (such at least an inner peripheral region  24   a  bordering a starter hole  30 ), is moldable or shapeable by manual manipulation, to enable the size and/or the shape of the hole  30  to be customized to match the size and/or shape of the ostomate&#39;s stoma  32  ( FIG. 3 ). A close or snug fit around the stoma  32  is highly desirable, in order to protect the ostomate&#39;s peristomal skin  34  from irritation and excoriation by contact with stool exuding from the stoma  32 . The adhesive  24  may, for example, be of either of the types described in the aforementioned U.S. Pat. No. 6,840,924, and U.S. Published Application No. 2006/0184145. Such an adhesive  24  is configured in a moldable wafer form to enable the adhesive  24  to be shaped while retaining a sheet-like form. In one form, the adhesive  24  comprises a laminate structure including plural layers of adhesive, and/or at least one layer of adhesive and at least one layer of plastics film. One or both of the pouch walls  16 ,  18  (e.g., the front wall  18 ) optionally is transparent, or includes a transparent portion, so that the user may more easily see the shape of the hole  30 , and the fit of the adhesive  24  around the stoma  32 , when in use. 
     As best seen in  FIG. 1 , the inner peripheral region  24   a  of the moldable adhesive  24  surrounding the starter hole  30  is pre-shaped during production of the body fitment  14  or the ostomy appliance  10 , to have a non-planar configuration. In this embodiment, the inner peripheral region  24   a  is bent or at least partly curled so as to bulge or protrude frontwardly, i.e., away from the body-facing side  26  of the adhesive. The inner peripheral region  24   a  has a frusto-conical, or flared, or at least partly curled, shape. The inner peripheral region  24   a  therefore lies more in front of a generally planar region  24   b  of the adhesive  24  near the outer periphery of the wafer. 
     The non-planar configuration of the adhesive  24   a  is supported by a release device in the form of a release member  36  that is supplied with the ostomy appliance  10 . The release member  36  covers and protects the adhesive surface on the body-facing side  26  of the wafer. The release member  36  comprises a support  36   a  in the form of an elevated projection to define and support the non-planar configuration of the adhesive  24   a.  The base of the support  36   a  has a larger transverse dimension (e.g., diameter or radius) than that of the starter hole  30 , such that the inner peripheral region  24   a  is supported in the non-planar shape defined by the support  36   a.  The release member  36  is made of, or is at least coated with, a release material such a silicone that does not stick strongly to the adhesive  24  of the wafer. For example, the release member  36  may be made of silicone coated card, silicone coated plastics, or silicone coated paper. At least the support  36   a  of the release member  36  is relatively stiff, so as to maintain a relatively well defined shape of the adhesive  24   a  around the hole  30 . The remainder of the release member  36  may be more flexible. Alternatively, it may also be relatively stiff so as to control the shape of the adhesive  24  generally throughout the wafer. The release member  36  may include a radially projecting tab  38 , or an annularly projecting periphery  38 , for enabling the release member  36  easily to be gripped and peeled from the adhesive  24  prior to use of the ostomy appliance  10 . Although in this embodiment the release device is formed by a single, one-piece release member  36  of which the support  36   a  is an integral part, in other embodiments, the support may be a separate element. For example, the release device may comprise a release sheet and a support non-integral with the release sheet. 
     In order to use the ostomy appliance  10 , the user removes the release member  36 , to expose the body-facing side  28  of the adhesive  24 . Even unsupported, the inner peripheral portion  24   a  of the adhesive  24  will tend to retain, at least for a period of time, the non-planar configuration previously imparted by the support  36   a  of the release member  36 . As illustrated in  FIG. 3 , the hole  30  in the adhesive  24  can be expanded to a customized shape and/or size by bending and rolling the adhesive  24   a  back on itself around the hole  30 , on the non-body-facing side  28  of the adhesive  24 . The non-planar configuration of the adhesive  24  makes it easier for a user to begin manipulating and rolling the adhesive  24  against the non-body-facing side  28 , even though the user has to perform this task by inserting his or her fingers through the hole  30  from outside the ostomy appliance  10 , i.e., the user only has access from the body-facing side  26  of the adhesive  24 . Since the adhesive region  24   a  is already bent away from the body-facing side  26  of the adhesive  24 , this promotes molding and folding of the adhesive  24  against the non-body-facing side  28 . The non-planar configuration can thus make molding the adhesive  24  easier than were the adhesive  24  (especially the inner peripheral region  24   a ) only to have a planar shape. If the front wall  18  is transparent, or includes a transparent portion, this may aid the user in seeing the shape that is molded. The rolled back surface of the adhesive  24  sticks to the non-body facing surface  28  (or a sheet provided thereon), thus forming a stable molded, rolled-back shape. As mentioned above, the adhesive  24  may have slight spring back characteristics if desired. 
     Once the inner peripheral region  24   a  of the adhesive  24  has been molded to obtain the desired custom shape and size of the hole  30 , the ostomy appliance  10  is pressed against the peristomal skin  34 , with the stoma  32  aligned with the hole  30 , in order to mount the ostomy appliance  10  on the body. 
     In the first embodiment, the adhesive  24  includes a generally planar portion  24   b.  If desired, the planar portion  24   b  of the adhesive  24  may be reinforced by a shape defining member  40  mounted against the non-body-facing side  28 . The optional shape defining member  40  may be in the form of an annular ring of a flexible, but relatively stiff, material (being stiff in comparison to the adhesive  24 ). The shape defining member  40  thus defines a generally annular non-shapeable (or constrained shape) zone  42  in the adhesive region  24   b  that is supported by, and has a shape controlled by, the shape defining member  40 . The wafer further includes a shapeable zone  44  inside the non-shapeable zone  42 . The shapeable zone  44  includes the inner peripheral region  24   a  of adhesive  24  having the non-planar configuration, and being moldable or shapable once the release member  36  has been removed. 
     In the second embodiment illustrated in  FIG. 4 , the shape defining member  40  itself has a non-planar shape, to define a bulge in the adhesive  24  towards the body-facing side  26 . Such a bulged shape may be suitable for an ostomate who has a recessed stoma. The adhesive  24  includes a rearwardly bulging portion  24   b  having a shape defined by the shape defining member  40 , and a frontwardly protruding or re-entrant portion, being the inner peripheral portion  24   a  around the hole  30 . The inner peripheral portion  24   a  lies more in front than the rearmost portion of the adhesive  24 . The release member  36  has a corresponding shape including an outer dish portion  36   b  to match the shape of the shape-defining member  40 , and a re-entrant support projection  36   a,  similar to the support  36   a  of the first embodiment, in order to define the frontward protruding shape of the inner peripheral portion  24   a  of adhesive  24 . 
     When the release member  36  is removed, the inner peripheral portion  24   a  of adhesive  24  is moldable (shapable zone  44 ) to enable the user to form the hole  30  into a desired size and shape, as in the first embodiment. The protruberance of the inner peripheral portion  24   a  bent away from the body-facing side  26  of the adhesive  24  promotes molding of the adhesive  24  by rolling against the non-body-facing side  28 . The portion  24   b  of the adhesive  24  supported by the shape-defining member  40  retains a generally well-defined, bulged shape controlled by the shape-defining member  40  (non-shapeable or constrained shape zone  42 ). 
     In the illustrated embodiment, the body fitment  14  further comprises an adhesive patch  46  made, for example, or fabric or microporous sheet, for adhering to the skin around the adhesive  24 . The adhesive surface of the patch  46  may initially be covered by the release member  36 , or by a separate release sheet that the user can peel from the patch  46  prior to adhering the ostomy appliance  10  to the skin. The ostomy appliance  10  further comprises an annular reinforcing ring  48  for stabilizing the shape of the stomal opening  22  of the ostomy pouch  12 . These elements may also be included in the other embodiments, as desired. 
     As illustrated by the first and second embodiments, the invention is especially suitable for enhancing the use of one-piece ostomy appliances, by pre-shaping the inner peripheral portion  24   a  of the adhesive  24  to protrude or project away from the body-facing side  26  of the adhesive  24 , so that it is more easily molded against the non-body-facing side  28  of the adhesive  24 . However, as illustrated by the following third embodiment, the invention also finds use when implemented in a two-piece appliance. 
     Referring to  FIG. 5 , in the two-part ostomy appliance  10 , the ostomy pouch  12  is releasably attachable to the body fitment  14  by means of an ostomy coupling  50 . The ostomy coupling  50  includes a pouch-side component  52  carried on the ostomy pouch  12  and releasably attachable to a fitment-side component  54  carried on the body fitment  14 . The two components  52  and  54  may be releasably attachable by means of a peelable adhesive, or by a mechanical interlocking or interference engagement. 
     In the third embodiment, the body fitment  14  includes the wafer of adhesive  24  including the non-planar configuration of the inner peripheral portion  24   a  of the adhesive around the starter hole  30 . The non-planar configuration of the adhesive  24  pre-disposes the inner peripheral portion  24   a  to be more easily molded by rolling or folding the adhesive  24  against the non-body-facing side  28 . In particular, the edge of the adhesive  24  around the opening  30  is bent away from the body-facing side  26  of the adhesive  24 . The pre-disposition of this edge of the adhesive  24  makes it easier, especially for elderly or non-dextrous users, to manipulate the adhesive  24  than were the inner peripheral portion  24   a  to have a flat or planar shape. Although the third embodiment is illustrated to have an adhesive shape similar to the first embodiment, it will of course be appreciated that the adhesive  24  may be given a bulged shape as in the second embodiment, by using a non-planar shape defining member. In the third embodiment, the entire ostomy appliance  10  may be supplied in a single package (not shown) similar to that of the first embodiment, or the body fitment  14  and the ostomy pouch  12  may be supplied in separate packages  15   a  and  15   b.    
     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.