Patent Description:
In particular, the invention relates to a so-called one-piece ostomy appliance in which a moldable adhesive body fitment is permanently attached to the pouch.

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

In a so-called one-piece appliance, the adhesive wafer is permanently attached to the appliance, to the extent that the adhesive wafer cannot easily be separated without risk of damaging the appliance. A one-piece appliance is intended to be used as an integral unit. A complaint sometimes made about one-piece appliances is that it is not always easy for elderly, visually impaired, or non-dexterous persons to adapt the size of the central opening in the adhesive wafer, because the appliance obstructs access from one side.

In a so-called two-piece appliance, the adhesive wafer forms part of a separate body fitment component that is attached by a releasable coupling. A two-piece appliance permits the body fitment to be separated from the appliance without damage, so that at least one of the components continues to be functionally usable. For example, the body fitment may remain in place on the body, and a replacement pouch mounted in place of a used pouch. While a two-piece appliance allows better access for adapting the wafer, a common complaint about two-piece appliances is that it is not always easy to align the components, particularly for elderly, visually impaired or non-dexterous users.

<CIT> describes an improved one-piece or two-piece 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 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. Contact by stool also progressively reduces the effectiveness of the adhesive. However, stomas have many different sizes and shapes. The advantage of a moldable adhesive as taught in <CIT> 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 <CIT> is implemented as a two-piece ostomy appliance, the wearer is able to access the moldable adhesive from both sides, including the non-body-contacting side, when the pouch is separated from the body fitment. This can enable the wearer easily to mold the adhesive, e.g., by folding or rolling it back from the non-body-contacting side. However, access is more restricted when implemented as a conventional style of one-piece appliance, as illustrated by the pouch <NUM> in <FIG> of the accompanying drawings. The wearer can only access the moldable adhesive <NUM> to mold the stomal aperture from a body-contacting side <NUM>, and not from an opposite non-body-contacting side <NUM> that is covered by the immovable pouch <NUM>. This makes molding the adhesive more difficult, and means that the shape and size of the aperture might not be as accurate as would be when the adhesive is accessible from both sides.

<CIT> and <CIT> describe alternative 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 angular sectors or arcs that together extend completely around the stoma aperture. In the first angular sector around the stoma aperture, the wafer is permanently attached immovably. In the second angular sector around the aperture, the wafer is initially unattached or is releasably attachable. The second angular sector is said to permit the pouch to be partly folded ajar of the wafer in the limited region of the second sector, allowing access through the gap created between the wafer and the pouch. This access is said to facilitate cutting the adhesive, or fitting a separate sealing member, or removal and fitting of a separate disposable inner pouch. However, such a solution illustrates the inherent incompatibilities associated with trying to combine two-piece behavior with an immovable body fitment of a one-piece appliance. With such a solution, the first sector in which the body fitment is immovable, hinders access to the body fitment because the pouch cannot be folded away in this region. Unless the second sector is made exceptionally large, access to the adhesive as a whole may still be restricted, making it difficult for an elderly or non-dexterous person to use the appliance. Additionally, there may be vulnerabilities in the seal between the faceplate and the pouch at (i) the points at where the first and second sectors meet around the periphery of the stoma aperture, and/or (ii) at the folding notches or creases of the stiffening ring that is used, in view of the discontinuities which are inevitable at all of these points.

A further manufacturing limitation of the conventional one-piece style of <FIG>, and the alternative arrangements described in <CIT> and <CIT>, is that the pouch <NUM> typically needs to be dimensioned to extend beyond the extremity of the adhesive <NUM> on all sides. This geometry is believed present in all of the mass-produced one-piece pouches currently available, and is a consequence of the manufacturing techniques used. The techniques typically require space for manufacturing equipment to come into intimate contact with the material for the pouch walls <NUM>, <NUM> to form a peripheral weld <NUM> and stamp the material, after the adhesive <NUM> has already been attached in its operative position around the entrance aperture <NUM>. The pouch <NUM> usually extends significantly below the entrance aperture <NUM> to provide the main collection volume of the pouch <NUM>, and so this geometry poses no problems for the lower portion of the pouch. However, the need for the pouch <NUM> also to extend upwardly above, and/or to either side of, the adhesive <NUM> results in unused headspace <NUM>. Such headspace <NUM> is undesirable because it cannot easily be used as part of the collection volume of the pouch, and it merely adds undesirably to the size of the pouch <NUM>. <CIT> describes an ostomy coupling assembly according to the preamble of claim <NUM>.

The present invention provides solutions to these problems.

One aspect of the present invention provides a coupling device according to claim <NUM>.

Other aspects of the invention are shown in claims <NUM>-<NUM>.

A second aspect of the invention provides an ostomy appliance, according to claims <NUM>-<NUM>.

As used herein the term "permanently attached" (or like phrases) means that the pieces are attached so strongly that they cannot be separated without breakage or damage that prevents reattachment without additional equipment. In the whole description, <NUM> (one) inch will be converted into <NUM>,<NUM>.

Referring to <FIG>, a first embodiment illustrates a one-piece ostomy appliance <NUM> comprising an ostomy pouch <NUM> and an adhesive wafer <NUM> permanently attached to the ostomy pouch <NUM>. The ostomy pouch <NUM> may be any of a colostomy pouch, a urostomy pouch and an ileostomy pouch.

The ostomy pouch <NUM> generally comprises a rear wall <NUM> and a front wall <NUM>. The front and rear walls <NUM>, <NUM> are made of flexible plastic films that are 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) or poly(vinylidene fluride) (PVDF). The walls <NUM>, <NUM> are welded together around a mutual periphery seam <NUM>. The rear wall <NUM> comprises a stomal or entrance aperture <NUM> through which stomal effluent enters the pouch <NUM>, in use. The pouch <NUM> optionally further comprises a deodorizing filter and vent (not shown) for deodorizing and venting flatus. Additionally or alternatively, the pouch <NUM> optionally further comprises a comfort panel (not shown) on the exterior surface of one or both of the walls <NUM>, <NUM>.

The adhesive wafer <NUM> comprises a skin compatible adhesive for attaching the appliance to peristomal skin, in use. The adhesive wafer <NUM> generally has a body-facing side <NUM> for facing towards and contacting the skin in use, and a non-body-facing side <NUM> that faces in the opposite direction. The body-facing side <NUM> may initially be protected by a release sheet <NUM>, for example, of silicone sheet or silicone-coated sheet. The adhesive wafer <NUM> is adaptable to enable a stomal aperture <NUM> to be formed and/or customized to match the size and shape of the ostomate's stoma <NUM> (<FIG>). Various techniques are envisaged for implementing such adaptation. In one form, the adhesive wafer <NUM> is of a moldable or shapeable type, in which at least a portion 34a of the adhesive is moldable or shapeable by manual manipulation. The adhesive wafer <NUM> may have a pre-formed starter stomal aperture <NUM> around which at least an inner peripheral region of adhesive wafer portion 34a is moldable or shapeable. Alternatively, if no starter stomal aperture <NUM> is provided, the adhesive may be of a type permitting a user to manually create and shape a suitable aperture <NUM> therein. The moldability and/or shapeability enables a close or snug fit to be achieved around the stoma <NUM>. A snug fit is highly desirable, in order (i) to protect the ostomate's peristomal skin <NUM> from irritation and excoriation by contact with stool exuding from the stoma <NUM>, as well as (ii) to form a seal that obstructs stomal effluent from contaminating the adhesive surface on the body-facing side <NUM>, which might otherwise reduce the wear-life of the appliance <NUM>. The adhesive wafer <NUM> may, for example, be of the type described in the aforementioned <CIT>. Such an adhesive wafer <NUM> enables shaping while retaining a sheet-like form. The adhesive wafer <NUM> comprises 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 stomal aperture <NUM> in the adhesive wafer <NUM> can be expanded to a customized shape and/or size by bending and rolling the adhesive wafer <NUM> back on itself around the stomal aperture <NUM>, as illustrated in <FIG>. Typically, the adhesive wafer <NUM> is rolled back on the non-body-facing side <NUM> of the adhesive wafer <NUM>, and this operation is most easily and accurately carried out from the non-body-facing side <NUM>. Alternatively, the adhesive may be of a flowable or extrudable mass type (not shown). Again, such adaptation is most easily and accurately carried out having access to at least the non-body-facing side <NUM> (preferably to both sides <NUM>, <NUM>).

In an alternative form, the stomal aperture <NUM> may be adapted or customized by fitting a separate sealing member (not shown) that seals insides the stomal aperture <NUM>. Such a sealing member is also best fitted to the non-body-facing side <NUM> of the adhesive wafer <NUM>, so as not to interfere with the adhesive interface between the body and the adhesive wafer <NUM> on the body-facing side <NUM>.

The present embodiment facilitates access to the non-body-facing side <NUM> of the adhesive wafer <NUM> because, initially, the adhesive wafer <NUM> is not attached immovably around the entrance aperture <NUM>. Instead, the appliance <NUM> further comprises one or both of:.

Prior to first use, the captive connection <NUM> permits relative displacement between the adhesive wafer <NUM> and the pouch <NUM> over a captive range of movement. The captive range of movement includes:.

Such an arrangement permits easy maneuvering of the pouch <NUM> and the adhesive wafer <NUM>, one with respect to the other, to provide convenient access to the adhesive wafer <NUM> from the non-body-contacting side <NUM>, substantially without obstruction by the pouch <NUM>. Preferably, the user has access from both sides <NUM>, <NUM>. The user is therefore able to form and/or shape and/or size the stomal aperture <NUM> easily without needing considerable dexterity to manipulate the appliance <NUM>.

In the illustrated forms, the captive connection <NUM> is preferably implemented in the form of a limited motion connection that guides the relative displacement along a predetermined locus or path of motion. Such a limited motion connection can guide the motion between the adhesive wafer <NUM> and/or pouch <NUM> to the operative position, at least in one dimension or degree of freedom. This can enable easier alignment of the adhesive wafer <NUM> with respect to the pouch <NUM> than, for example, a conventional two-piece appliance in which the adhesive wafer <NUM> is generally freely movable with respect to the appliance prior to fixation.

The user can decide how best to fit the appliance <NUM> to the body. In one technique, the user adapts the adhesive wafer <NUM> substantially entirely before fitting the appliance <NUM> to the body. Having adapted the adhesive wafer <NUM> in the non-superposed position, the user moves the adhesive wafer <NUM> to its operative position (<FIG> and <FIG>) prior to fitting the appliance <NUM> to the body. The adhesive wafer <NUM> is fixed in position by the fixation coupling <NUM>, after which the appliance <NUM> is fitted to the body in the style of a conventional one-piece appliance.

In another technique that may be preferred by many users (illustrated in <FIG>), the adhesive wafer <NUM> is fitted to the body <NUM> before the adhesive wafer <NUM> is fixed in its operative position with respect to the pouch <NUM>. This technique permits the user to adapt or further adapt the stomal aperture <NUM> in situ around the stoma <NUM>, accessing the adhesive wafer <NUM> from the non-body-facing side <NUM>. The flexibility of the pouch <NUM> may enable the pouch <NUM> to be easily folded away from the entire adhesive wafer <NUM>, and to expose the non-body-contacting side <NUM> of the adhesive wafer <NUM> to the user. Once the user is content with the custom fit of the stomal aperture <NUM> to his or her stoma <NUM>, the user then moves or unfolds the pouch <NUM>, to bring the entrance aperture <NUM> to the operative position with respect to the adhesive wafer <NUM> (indicated by arrow <NUM>). If a limited motion connection is implemented, the connection guides the motion to the operative position, greatly assisting the user. Once in the operative position, the pouch <NUM> is then fixed relative to the adhesive wafer <NUM> by the fixation coupling <NUM>.

Various ways are envisaged for implementing (i) the captive connection <NUM>, and (ii) the fixation coupling <NUM>.

The captive connection <NUM> may be at least one of flexible, bendable, rotatable, pivotable, twistable, and/or stretchable to permit the relative displacement. In an alternative form, the captive connection <NUM> could be substantially rigid, and the relative displacement provided by the flexibility of the pouch <NUM> itself.

In the form illustrated in <FIG>, the captive connection <NUM> comprises a bendable and/or hinged connection. The captive connection <NUM> comprises a first attachment portion <NUM>, a second attachment portion <NUM>, and a bendable or hinged joint <NUM> between the two portions <NUM>, <NUM>. The captive connection <NUM> may be made of a single piece of material, and the bendable joint <NUM> may be implemented as an integral hinge, such as a folding or bendable portion, or a living hinge, or a region that is any of: weakened, thinned, perforated and/or scored. For example, the captive coupling <NUM> may be made of a single piece of plastics film. The film may be flexible, and optionally weakened to define the joint <NUM> at which the film is encouraged to bend.

Alternatively, referring to <FIG>, the two portions <NUM>, <NUM> may be distinct members joined by a hinge piece 70a or 70b. The hinge piece 70a may, for example, be of flexible material, such as a fabric or flexible film. Alternatively, the hinge piece 70b may be a hinge mechanism, possibly including a rotating pivot.

In the forms illustrated in <FIG>, the joint <NUM> permits relative displacement about an axis that extends generally parallel to a major plane of the adhesive wafer <NUM> and/or of the pouch <NUM> (when straight). One advantage of this arrangement is that, when the adhesive wafer <NUM> is displaced with the respect to the entrance aperture <NUM>, the non-body-facing side <NUM> of the adhesive wafer <NUM> is automatically exposed and presented to the user. For example, with relative displacement of about <NUM> degrees (<FIG>, <FIG>, <FIG> and <FIG>), the non-body-contacting side <NUM> is presented facing the user on the rear pouch wall <NUM>. Such geometry provides exceptionally convenient access to the non-body-contacting side <NUM> of the adhesive wafer <NUM>, even with the adhesive wafer <NUM> permanently attached to the pouch <NUM> as a one-piece appliance. The user is thus able easily to access the adhesive wafer <NUM> from at least the non-body-contacting side <NUM> in order to permit the most accurate and versatile adaptation of the stomal aperture <NUM>.

The first attachment portion <NUM> is configured to be attached permanently to the pouch <NUM>, for example, by welding or by strong adhesive. The first attachment portion <NUM> could be attached to either of the pouch walls <NUM>, <NUM>, and/or at the seam <NUM>. In the illustrated form, the first attachment portion <NUM> is attached to the rear wall <NUM> adjacent to the entrance aperture <NUM>. The first attachment portion <NUM> comprises a generally hollow form (preferably closed-loop in shape) that extends at least partly (and preferably entirely) around the entrance aperture <NUM>. The first attachment portion <NUM> may serve to reinforce the pouch wall material around the entrance aperture <NUM>, to prevent wrinkling or stretching, and to provide a good surface for the fixation coupling <NUM>.

The second attachment portion <NUM> is configured to be attached permanently to the adhesive wafer <NUM>, for example, by welding or by strong adhesive action (for example, between the adhesive of the adhesive wafer <NUM> and the second attachment portion <NUM>). In the illustrated form, the second attachment portion <NUM> is attached to the adhesive wafer <NUM> on the non-body-contacting side <NUM>, in a peripheral region 34b surrounding the inner peripheral region 34a. The second attachment portion <NUM> may have any desired form. As illustrated, the second attachment portion <NUM> comprises a generally hollow form (preferably closed-loop in shape) that extends at least partly (and preferably entirely) around the stomal aperture <NUM> and/or adaptable region 34a.

The captive connection <NUM> may resemble a figure-of-eight shape, comprising two closed-loop forms disposed side-by-side (either immediately adjacent, or slightly separated), and coupled by the joint <NUM>.

The first and second attachment portions <NUM>, <NUM> are typically of about the same size, i.e., having the same size of inner and/or outer diameter so as to fit substantially back to back in the operative position. Each attachment portion may have a respective tab 66a, 66b, positioned so that the tabs 66a, 66b generally entirely overlap each other in register in the operative position. The tabs 66a, 66b permit easy manipulation of the captive connection <NUM>.

Referring to <FIG> and <FIG>, an alternative joint <NUM> comprises a pivot <NUM> that permits relative pivotable movement between the pouch <NUM> and the adhesive wafer <NUM> in a plane generally parallel to the plane of the pouch <NUM> (when straight) and/or generally parallel to a major plane of the adhesive wafer <NUM>. The pivot <NUM> may define a pivot axis that is generally perpendicular to the plane of the pouch <NUM> (when straight) and/or generally perpendicular to a major plane of the adhesive wafer <NUM>. The pivot <NUM> may comprise a pin, lug or rivet received in apertures in overlapping tabs 66b, 68b of the first and second attachment portions <NUM>, <NUM>. In the illustrated form, the first and second attachment portions <NUM>, <NUM> are each closed-loop in shape. The pivot <NUM> permits the first and second attachment portions <NUM>, <NUM> to be moved from generally concentric, superposed relation (corresponding to the operative position) to generally non-concentric, non-superposed relation, permitting access to the adhesive wafer <NUM> away from the entrance aperture <NUM>. As can be seen from <FIG>, there is no reversal of the positions of the body-facing side <NUM> and non-body-facing side <NUM> when the captive coupling is rotated. Nevertheless, the flexibility of the plastics films forming the first and second attachment portions <NUM>, <NUM> permits easy access to the non-body-facing side <NUM> when the wafer <NUM> is rotated away from the operative position.

<FIG> shows a modification of the second embodiment that provides an additional positive fit when the adhesive wafer <NUM> is rotated to its operative position. The adhesive wafer <NUM> is dimensioned so that its outer diameter is slightly smaller than the inner diameter of the fixation coupling adhesive <NUM> carried on the first attachment portion <NUM>, enabling the adhesive wafer <NUM> to nest at least partly within the aperture of the fixation coupling adhesive <NUM>. This nesting provides additional tactile information to the user that the adhesive wafer <NUM> is correctly aligned at the operative position. The same technique of a nested fit may also be used with the other embodiments described herein.

Referring to <FIG>, an alternative captive connection <NUM> has a similar folding action to that of <FIG>, except that the first attachment portion <NUM> for attachment to the pouch <NUM> has the form of a tab instead of a closed-loop shape. Two different configurations of tab are envisaged. In <FIG> and <FIG>, the joint <NUM> is disposed on the portion of the tab <NUM> facing away from the entrance aperture. In the same manner as that of <FIG>, the joint <NUM> is unfolded in the access position, and folds over on itself when the entrance aperture <NUM> and adhesive wafer <NUM> are in the operative, superposed position. The joint <NUM> unfolds as the adhesive wafer <NUM> is displaced away from the entrance aperture <NUM>.

In the alternative arrangement of <FIG> and <FIG>, the joint <NUM> is disposed generally between the tab <NUM> and the entrance aperture <NUM>. In the access position, the joint <NUM> is folded. In the operative, superposed position of the entrance aperture <NUM> and the adhesive wafer <NUM>, the joint <NUM> is generally unfolded.

When a tab <NUM> is used, an additional reinforcing member <NUM> may be provided encircling the entrance aperture <NUM>. The reinforcing member <NUM> may have a tab 80a to aid manipulation of the pouch <NUM>. The reinforcing member <NUM> is made of a material having a greater flexural modulus than the material of the pouch wall <NUM>, <NUM>, so as to protect the pouch wall <NUM>, <NUM> against wrinkling, and facilitate a good seal around the entrance aperture <NUM>.

The fixation coupling <NUM> may be adhesive or a mechanical coupling. The fixation coupling <NUM> may be of a permanent type such that the fixation coupling <NUM> is not intended to be separated (nor re-fastened) after the initial fastening together. Alternatively, the fixation coupling <NUM> may be of a separable and re-fastenable type. This may permit a care-giver or nurse to temporarily open the pouch <NUM> away from the adhesive wafer <NUM>, to enable inspection, cleaning, or application of medication to the stoma <NUM> while the adhesive wafer <NUM> is in situ on the body.

An adhesive coupling is currently preferred for implementing the fixation coupling <NUM>. An adhesive coupling typically provides a lower profile height than a mechanical coupling. The adhesive coupling may use the skin-friendly adhesive of the adhesive wafer <NUM>, or it may use a different adhesive. The adhesive coupling may comprise self-adhering films that stick to each other without being tacky.

In one form (as illustrated in all of the embodiments), the fixation coupling <NUM> comprises an adhesive layer <NUM> distinct from the wafer <NUM> and carried by at least one of the first and second attachment portions <NUM>, <NUM> of the captive connection <NUM>. Either both attachment portions <NUM>, <NUM> may carry such adhesive, or one of the attachment portions <NUM>, <NUM> may be a non-adhesive landing zone. In the form illustrated in <FIG>, the first attachment portion <NUM> carries the adhesive <NUM> and a landing surface is provided by the second attachment portion <NUM>. However, the position of the adhesive may be reversed as desired. The adhesive layer <NUM> may initially be protected by a silicone or silicone-coated release sheet <NUM>. The release sheet <NUM> may have a peel tab <NUM> that is typically spaced angularly away from the tab 66a, 80a to avoid confusion. The adhesive <NUM> may of the same type and/or thickness suitable for use in adhesive-coupling two-part ostomy appliances, and so does not increase significantly the thickness or profile height of the appliance <NUM>.

<FIG> illustrate a further example of the captive connection <NUM> in which adhesive <NUM> is carried by both the first and second attachment portions <NUM>, <NUM> on their respective surfaces that confront when in the operative position. These drawings also illustrate an example construction of the adhesive wafer <NUM>, including adhesive layers 34c, 34e separated by a flexible sheet 34d providing a similar moldable characteristic as explained in the aforementioned <CIT>.

In another form, the fixation coupling <NUM> comprises a portion of the adhesive surface of the adhesive wafer <NUM> on the non-body-facing side <NUM>.

In the above embodiments, the adhesive wafer <NUM> is sized and positioned so that it generally lies inside the welded periphery <NUM> of the pouch <NUM>. However, a further feature of the present invention is that it can provide a one-piece appliance <NUM> in which the adhesive wafer <NUM> extends all of the way up to, or even beyond, the peripheral weld <NUM> of the pouch <NUM> when the adhesive wafer <NUM> is in the operative condition, for example, as illustrated in <FIG>. Such a design is possible because, the captive connection <NUM> permits the adhesive wafer <NUM> to be displaced, during manufacture, to a position in which the adhesive wafer <NUM> is clear of the position at which the peripheral weld <NUM> is to be made. This enables conventional welding equipment to approach the position of the peripheral weld <NUM> without being obstructed by the wafer <NUM>. This modification may be used in combination with any of the captive connections and/or fixation couplings described herein.

The same principles discussed above may also be applied to a two piece appliance and/or to a one-piece appliance supplied in separated or "kit" form. In the case of a two-piece appliance, the fixation coupling <NUM> may be the conventional two-piece coupling of either an adhesive or a mechanical interference/interlock type. The first attachment portion <NUM> of the captive connection <NUM> is preferably securable, for example, releasably, to the pouch prior to aligning and securing the components of the two-piece appliance.

The above principles are now illustrated by further detailed examples:.

An appliance <NUM> is made to include a pouch <NUM> for collecting material, an entrance aperture <NUM> through which material enters the pouch <NUM>, an adhesive wafer <NUM> for attaching the pouch <NUM> to a surface where collection will be accomplished, and a coupling component <NUM>,<NUM> for coupling of the adhesive wafer <NUM> to the pouch <NUM>.

The pouch <NUM> is formed by welding together two panels of film about an elliptical perimeter approximately <NUM> inches wide by approximately <NUM> inches long, one of the panels having an opening where material to be collected enters the pouch <NUM>. A flexible, closed cell foam with thickness of approximately <NUM> inches comprised of polyethylene-co-vinyl acetate coated on one side with a polyacrylate adhesive is cut into a single shape of two adjoining rings or circles resembling the number "<NUM>" (<FIG>). The uncoated side of one circle of the coupling (representing the first attachment portion <NUM>) is thermally welded to a pouch film panel so that the circle encompasses the entrance aperture <NUM> about its entire circumference.

A hydrocolloid adhesive comprising an adhesive wafer <NUM> having a formulation described by any of the examples <NUM> - <NUM> in <CIT> is shaped into an adhesive wafer <NUM> approximately <NUM> inches thick with an inner diameter of approximately <NUM> and an outer diameter approximately equal to the outer diameter of the second circle of the <FIG> shaped coupling foam. The hydrocolloid adhesive wafer <NUM> is protected on one side by a coated release sheet <NUM>. The opposite side of the hydrocolloid adhesive wafer <NUM> is adhered to the second circle (representing second attachment portion <NUM>) on the uncoated side of the coupling foam. The inside diameter of the hydrocolloid adhesive wafer <NUM> is smaller than the inside diameter of the second attachment portion <NUM> to which it is adhered, and the hydrocolloid adhesive within the coupling inner diameter is protected with a second release liner <NUM>.

In preparation for use, either or both release liners <NUM>, <NUM> are removed. With the hydrocolloid adhesive now exposed it is adapted as desired for improved performance, for example, by manually adjusting the dimensions of the stomal aperture <NUM> to match the collection surface and improve efficient collection of material by the pouch <NUM>.

The two circles of the <FIG> shaped coupling are now folded together along an axis near where they adjoin (at <NUM>) such that the adhesive coated surface of each circle contacts the other and the adhesive wafer <NUM> and pouch <NUM> are now coupled together. The adhesive wafer <NUM> now indirectly abuts the entire circumference of the entraance aperture <NUM> via the coupling. Any remaining release liner <NUM>, <NUM> is removed from the hydrocolloid adhesive wafer <NUM> and the adhesive wafer <NUM> is adhered to a surface for collection of material, for example, attaching to the skin <NUM> around a stoma <NUM> as for a one- piece appliance with a moldable adhesive.

A pouch <NUM> and adhesive wafer <NUM> of similar construction to those described in Example <NUM> above are coupled together using a self-adhering film with thickness of approximately <NUM> inches and shaped into a <FIG>. The area where the circles are adjoined is small compared with the total area of the circles. One circle (representing first attachment portion <NUM>) is thermally welded to the pouch film panel, the weld joint entirely encompassing the entrance aperture <NUM>. The hydrocolloid adhesive wafer <NUM> is shaped into a round disc approximately <NUM> inches thick with outer diameter approximately equal to the outer diameter of the second circle of the coupling film (representing second attachment portion <NUM>). The hydrocolloid adhesive wafer <NUM> is adhered to the second circle on the side of the coupling film opposite from the side welded to the pouch panel. The adhesive wafer <NUM> is adapted for use as described in Example <NUM>. The two circles of the <FIG> shaped film coupling are now twisted and folded together along an axis near where they adjoin such that the free surfaces of each circle contact and self-adhere to one other, coupling the pouch <NUM> to the attachment adhesive in a manner that prevents escape of the collected material through the coupling components. The pouch <NUM> may be used to collect material as described in Example <NUM> above.

The pouch <NUM> and hydrocolloid adhesive wafer <NUM> of similar construction to those described in Example <NUM> above are coupled together using an essentially flat polyethylene vinyl acetate sheet with thickness of approximately <NUM> inches and shaped into a <FIG>. The point of adjoining between the circles is heated and pressed to reduce its thickness and create a hinge <NUM> to facilitate folding or twisting. One circle (representing first attachment portion <NUM>) is adhered with a pressure sensitive adhesive to the pouch film panel, the circle encompassing the entrance aperture <NUM>. The hydrocolloid adhesive wafer <NUM> is shaped into a round disc approximately <NUM> inches thick with outer diameter equal to the outer diameter of the second circle of the <FIG> coupling sheet (representing the second coupling portion <NUM>). The hydrocolloid adhesive wafer <NUM> is adhered to the coupling and adapted for use as described in Example <NUM>. The two circles of the <FIG> shaped sheet coupling are now folded together using the hinge <NUM> to create contact between the circles. The pouch <NUM> may be used to collect material by removing the release liner <NUM>, <NUM> from the hydrocolloid adhesive wafer <NUM> and attaching it to a surface, for example, attaching to the skin <NUM> around a stoma <NUM>.

The pouch <NUM> and hydrocolloid adhesive wafer <NUM> of similar construction to those described in Example <NUM> above are coupled together using a plastic polyethylene coupling with total thickness of approximately <NUM> inches and shaped into a <FIG>. The circumference of each circle is essentially flat and includes a sealing component comprised of corresponding surfaces that can be mechanically interlocked when brought together, for example, a raised rim and indented groove. The area of adjoining (at <NUM>) between the circles is reduced in thickness using a routing tool creating a hinge to facilitate folding or twisting. One circle (representing first attachment portion <NUM>) is essentially flat and thermally welded to the pouch film panel, the circle encompassing the entrance aperture <NUM>. Attached to the outer periphery of this circle at a position approximating the circumference where it is welded to the pouch wall <NUM>, <NUM> is an adhesive coated non-woven fabric. The adhesive is protected by a release liner <NUM>, <NUM> and coated on the side of the fabric next to the coupling.

The hydrocolloid adhesive is shaped into an adhesive wafer <NUM> approximately <NUM> inches thick with outer diameter approximately equal to the outer diameter of the second circle of the <FIG> plastic coupling (representing the second attachment portion). The hydrocolloid adhesive wafer <NUM> is adhered to the second circle on the same side of the coupling as is welded to the pouch wall <NUM>, <NUM>. In this case the plastic coupling is shaped to facilitate adhesion to a recessed surface by imparting a convex shape to the plastic part such that it juts out away from the entrance aperture <NUM> when the coupling is in its final configuration. The hydrocolloid adhesive wafer <NUM> being adhered to the convex shaped portion of the coupling takes on that convex shape.

The hydrocolloid adhesive wafer <NUM> is adhered to the coupling and adapted for use as described in Example <NUM>. The two circles of the <FIG> shaped sheet coupling are now folded together using the hinge <NUM> to facilitate contact between the circles. The coupling is now secured in its final orientation by an interlocking mechanism (representing a mechanical fixation coupling <NUM>), for example, by inserting the raised rim of one side of the coupling into the corresponding indented groove of the other side of the coupling. The pouch <NUM> may be used to collect material by removing the release liner from the hydrocolloid adhesive wafer <NUM> and attaching it to a surface, for example, attaching to the skin <NUM> around a stoma <NUM>. The pouch <NUM> is now made further secure to the surface where collection will be made by adhering the adhesive coated fabric onto the same surface where the hydrocolloid adhesive wafer <NUM> is attached.

The appliance <NUM> including the pouch <NUM> and hydrocolloid adhesive wafer <NUM> of similar construction to those described in Example <NUM> above are coupled together using a coupling of two discreet ring shaped attachment portions <NUM>, <NUM> attached together using a rivet <NUM> such that the attachment portions <NUM>, <NUM> may be freely rotated from an at least partially non-concentric position to a substantially concentric final position. Through this rotation they are made to adjoin across communicating surfaces and align with the pouch entrance aperture <NUM>. One ring of the coupling (representing first attachment portion <NUM>) is attached to the pouch <NUM> on one surface opposite the communicating surface, and the other ring (representing second attachment portion <NUM>) of the coupling is attached to the hydrocolloid adhesive wafer <NUM> on another surface opposite the communicating surface. A coupling adhesive or gasket material on one or both communicating surfaces maintains the coupling in its final position and aids in the retention of collected material.

The appliance <NUM> including the pouch <NUM>, hydrocolloid adhesive wafer <NUM> and coupling components of similar construction to those described in Example <NUM> above are coupled together using a rivet <NUM> such that the coupling components may be freely rotated from an at least partially non-concentric position to a substantially concentric final position. Through this rotation they are made to adjoin across communicating surfaces and align with the entrance aperture <NUM>. One ring of the coupling (representing first attachment portion <NUM>) is attached to the pouch <NUM> on one surface opposite the communicating surface, and the other ring of the coupling (representing second attachment portion <NUM>) is attached to the hydrocolloid adhesive wafer <NUM> on another surface opposite the communicating surface. In this example the diameters of the pouch coupling ring are designed larger than those of the hydrocolloid adhesive wafer coupling ring such that the outer diameter of the latter entirely fits inside the inner diameter of the former. When rotated into its final configuration the hydrocolloid adhesive wafer coupling ring is inserted into the pouch adhesive coupling ring in a substantially coplanar configuration with the result that the hydrocolloid adhesive wafer <NUM> attaches to the collection surface on one side and to both coupling rings on the opposite side.

The appliance <NUM> including the pouch <NUM> and hydrocolloid adhesive wafer <NUM> of similar construction to those described in Example <NUM> above are coupled together using a coupling comprised of a flexible, closed cell foam with thickness of approximately <NUM> inches comprised of polyethylene-co-vinyl acetate coated on one side with a polyacrylate adhesive. The polyacrylate adhesive is protected with a release liner <NUM>, <NUM> prior to use. The coupling is cut into a single annular shape that is attached to the pouch wall <NUM>, <NUM> with the entrance aperture <NUM> via a tabbed area <NUM> extending radially from the outer diameter of the coupling ring between the coupling ring and the entrance aperture <NUM>. The uncoated side of the coupling is adhered to the hydrocolloid adhesive wafer <NUM>. The adhesive wafer <NUM> is then adapted as described in Example <NUM>. The coupling is then folded across the tab <NUM> so that exposed polyacrylate adhesive attaches to the pouch <NUM> and encompasses the entrance aperture <NUM> about its entire circumference. Any remaining release liner <NUM>, <NUM> is removed from the hydrocolloid adhesive wafer <NUM> and the adhesive wafer <NUM> is adhered to a surface for collection of material, for example, attaching to the skin <NUM> around a stoma <NUM> as for a one-piece appliance with a moldable adhesive.

Alternatively, the tabbed portion <NUM> of the coupling may be on the opposite side of the coupling ring form the entrance aperture <NUM>. In this case adaptation of the hydrocolloid adhesive wafer <NUM> is accomplished by deflecting the tab <NUM> so that access to either surface of the hydrocolloid adhesive wafer <NUM> is easily attained. Once the hydrocolloid adhesive wafer <NUM> is adapted the polyacrylate adhesive coated surface of the coupling is adhered to the pouch <NUM> about the entrance aperture <NUM>.

As a further option the area around the entrance aperture <NUM> may be reinforced to facilitate handling by attachment of an adhesive wafer <NUM> around the entire circumference of the entrance aperture <NUM>, the reinforcing component having a flexural modulus exceeding that of the pouch panel material.

The appliance <NUM> including the pouch <NUM> and hydrocolloid adhesive wafer <NUM> of similar construction to those described in Example <NUM> above including a coupling comprised of a flexible film, foam, non-woven or other sheet of flexible material with a minimum thickness of approximately <NUM> inches and shaped into a <FIG>. The coupling is coated on one side with at least <NUM> inch thick pressure sensitive adhesive coating that is protected with release liner <NUM>, <NUM> prior to use.

The area where the circles are adjoined is small compared with the total area of the circles. One circle (representing the first attachment portion <NUM>) is thermally welded to the pouch wall <NUM>, <NUM>, the weld joint entirely encompassing the entrance aperture <NUM>. The hydrocolloid adhesive wafer <NUM> is shaped into a round disc approximately <NUM> inches thick with both outer and inner diameters approximately equal to those of the second circle of the coupling. The hydrocolloid adhesive wafer <NUM> is adhered to the second circle on the side of the coupling opposite from the side welded to the pouch wall <NUM>, <NUM>. The adhesive together with the coupling is adapted for use as described in Example <NUM> with the advantage being that the hydrocolloid adhesive wafer <NUM> facing the interior of the pouch <NUM> is now further protected from the collection material in the area where it is covered by the coupling. The two circles of the <FIG> shaped coupling are now twisted and folded together along an axis near where they adjoin such that the free surfaces of each circle contact one other coupling the pouch <NUM> to the adhesive wafer <NUM> in a manner that prevents escape of the collected material through the coupling components. The pouch <NUM> may be used to collect material as described in Example <NUM> above.

The appliance <NUM> including the pouch <NUM>, hydrocolloid adhesive wafer <NUM> and coupling components of similar construction to those described in Example <NUM> above are coupled together using self-adherent materials that resist stomal effluent. A foam ring coated with a silicone coating having a probe tack less than <NUM> grams, force, as measured by the method described above, is attached on the uncoated side about the entire circumference of the entrance aperture <NUM> by a thermal weld. A non-pressure sensitive adhesive sheet that is approximately <NUM> inch thick and comprised of polyethylene vinyl acetate or a flexible thickness of polyester sheet is cut into a tabbed ring and thermally welded to the pouch wall <NUM>, <NUM> having the entrance aperture <NUM>. The adhesive wafer <NUM> is then adapted as described in Example <NUM>. One side of the tabbed ring is adhered to the hydrocolloid adhesive wafer <NUM> and the opposite side is brought into contact with the silicone coating. Any remaining release liner <NUM>, <NUM> is removed from the hydrocolloid adhesive wafer <NUM> and the adhesive wafer <NUM> is adhered to a surface for collection of material, for example, attaching to the skin <NUM> around a stoma <NUM> as for a one-piece appliance with a moldable adhesive.

Claim 1:
An ostomy coupling assembly for fastening an adhesive wafer (<NUM>) to an ostomy pouch (<NUM>), the ostomy pouch having an entrance aperture (<NUM>), and the adhesive wafer including a body-facing side (<NUM>) for contacting a user's skin, a non-body-facing side (<NUM>) opposite the body-facing side (<NUM>), and an adaptable region (34a) adaptable to fit around a stoma, the coupling comprising:
a limited motion connection (<NUM>) between the adhesive wafer (<NUM>) and the ostomy pouch (<NUM>) that permits relative displacement between (i) substantially the entire adhesive wafer (<NUM>) and (ii) the entrance aperture (<NUM>) of the ostomy pouch (<NUM>), the limited motion connection guiding said relative displacement along a limited motion path or locus, between (a) an operative position in which the adhesive wafer (<NUM>) is superposed around the entrance aperture (<NUM>) of the ostomy pouch (<NUM>), and (b) an access position providing access to the adaptable region (34a) from the non-body-facing side (<NUM>); and
a fixation coupling (<NUM>) for fixing the adhesive wafer (<NUM>) and the ostomy pouch (<NUM>) when in the operative position;
characterised in that
the limited motion connection (<NUM>) comprises a first attachment portion (<NUM>) configured to be attached permanently to the ostomy pouch (<NUM>), a second attachment portion (<NUM>) configured to be attached permanently to the adhesive wafer (<NUM>), and a movable joint portion (<NUM>) between the first and second attachment portions (<NUM>, <NUM>); and
wherein the limited motion connection (<NUM>) comprises a single piece of material.