Adaptor for ostomy coupling

An adapter is disclosed for an ostomy coupling. The adapter provides a floatable coupling characteristic to an ostomy body fitment that has a non-floatable coupling part. The adapter comprises a first coupling part for attaching to the non-floating coupling part of the body fitment, a second coupling part for releasably attaching to an ostomy appliance, and a flexible collar between the first and second coupling parts. The flexible collar permits the second coupling part to be displaced away from the first coupling part, thereby creating a space for an ostomate to manually brace the second coupling part against an attachment force when an appliance is fitted.

FIELD OF THE INVENTION

The present invention relates to an ostomy coupling for removably attaching an ostomy appliance to a body fitment worn on the body of an ostomate. In one form, the invention relates to providing a body fitment with a floatable coupling part.

BACKGROUND TO THE INVENTION

The ostomy coupling shown in British Patent Specification No. 1571657 and illustrated inFIG. 1of the present application has received wide acceptance and approval among ostomates. The coupling comprises first and second inter-engageable coupling parts10,12which are securable together with a press fit. The first coupling part10comprises an annular rib and is directly mounted on an adhesive wafer14of the body fitment. The second coupling part12comprises an annular channel member and is mounted around the mouth of a collection pouch16. The coupling parts10,12are manufactured in a range of different diameters to suit different stoma size requirements, and the ostomate selects components of matching coupling size.

U.S. Pat. No. 4,419,100, U.S. Pat. No. 4,610,676, U.S. Pat. No. 4,610,677 and U.S. Pat. No. 5,730,735 teach a modification designed to reduce discomfort that some ostomates may experience as a result of the attachment force applied through the body fitment to the skin, when the coupling parts are pressed together. The problem of discomfort is especially important during post-operative care, when the stoma surgery is recent and the abdominal skin is very tender. These latter documents teach a flexible collar suspension permanently secured between the adhesive wafer and the coupling part of the body fitment. The flexible collar allows the coupling part to be displaced away from or “float” with respect to the adhesive wafer, at least by a sufficient amount for a user to insert one or more fingers behind the coupling part, in order to manually support the coupling part against the attachment force when the appliance is pressed against the body fitment. While this technique is successful in reducing transmission of the attachment force to the sensitive abdominal skin during post-operative care, there are several disadvantages that make this type of coupling less than ideal for everyday use: (1) the appliances tend to be larger than equivalent systems where no flexible collar is used; (2) the profile of the system is higher than similar systems without a flexible collar, due to the increased thickness; (3) there is a tendency for the appliance to sag away from the adhesive wafer, since the flexible collar is explicitly provided to allow the pouch to float away from the surface of the wafer; and (4) the cost of the device is higher than a conventional system without a flexible collar, since the manufacturing costs are higher. A manufacturer wishing to accommodate specific customer preferences for post-operative care, and also different customer preferences for everyday use, would need to manufacture different types of body fitment both with, and without, the flexible collar, leading to significant burden of increased inventory and manufacturing costs.

The present invention has been devised bearing the above in mind.

SUMMARY OF THE INVENTION

In one form, the present invention provides an adapter for an ostomy coupling. The adapter provides a floatable coupling characteristic, for an ostomy body fitment that has a non-floatable coupling part.

Thus, the invention solves the problem of increased inventory and manufacturing costs by enabling a single type of body fitment, with a non-floatable coupling part, equally to be used with the adapter to provide a floatable characteristic. Use of such an adapter can avoid the need for a manufacturer to produce, and stock, different types of body fitment with, and without, the floatable coupling feature. Instead, when a floatable coupling part is desired for post-operative or specialized care, the ostomate or care giver can use a standard body fitment without a floatable coupling part, and attach the adapter to that body fitment to obtain the desired floatable coupling feature. The adapter can thereby significantly enhance the versatility of existing ostomy equipment, and reduce inventory and manufacturing cost burden to meet different ostomates' preferences.

The adapter comprises a first coupling part for attaching to the body fitment, a second coupling part for releasably attaching to an ostomy appliance, and a flexible collar between the first and second coupling parts. The flexible collar permits the second coupling part to be displaced away from the first coupling part, thereby creating a space for an ostomate to manually brace the second coupling part against an attachment force when an appliance is fitted.

As used herein, the term “releasably attaching” and derivatives thereof mean that two coupling parts are attachable and detachable, using forces applied by hand, and without destruction of either part. The term “floatable” means that a coupling part is movable towards and away from an adhesive wafer, to create a space for a user to manually brace that coupling part, in order to relieve attachment forces being applied through the adhesive wafer.

While features believed to be most important are highlighted above, in description, and in the appended claims, the Applicants may seek claims protection for any novel feature or idea disclosed herein and/or in the drawings, whether or not emphasis has been placed thereon.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

In the accompanying drawings, the same reference numerals are used to denote the same or equivalent features in each embodiment.

Referring toFIGS. 2 and 3, ostomy apparatus20generally comprises a body fitment22, an ostomy appliance24, and an adapter26. The body fitment22comprises an adhesive wafer28with a stomal orifice29, for attachment to the ostomate's skin30(FIG. 3), and a body fitment coupling part32that is secured to the adhesive wafer28around the stomal orifice29. The adhesive wafer28may be made of any suitable skin-friendly ostomy adhesive, such as described in U.S. Pat. No. 4,166,051, U.S. Pat. No. 4,393,080, or other compositions designed for use around a stoma. The body fitment coupling part32is secured in such a manner that at least a portion of the coupling part32is fixed in position with respect to the wafer28. For example, the body fitment coupling part32may be welded or bonded to the adhesive wafer28or a backing (not shown) of the adhesive wafer28. The body fitment coupling part32may be referred to as non-floatable, since it is not possible to displace the body fitment coupling part32substantially with respect to the adhesive wafer28.

The ostomy appliance24comprises a collection pouch, although the invention is applicable to any form of ostomy appliance, such as a stoma port, or a controlled discharge appliance. The ostomy appliance24also comprises an appliance coupling part38surrounding an entrance aperture39of the ostomy appliance24.

The adapter26serves to provide the body fitment22with a floatable coupling part characteristic. By using the adapter26, the manufacturing and inventory burden can be significantly reduced, because the adapter26can avoid the need for a manufacturer to produce, and stock, different types of body fitment22with, and without, the floatable coupling feature. Instead, when a floatable coupling part is desired for post-operative or specialized care, the ostomate or care giver can use a standard body fitment22without a floatable coupling part, and attach the adapter26to that body fitment22to obtain the desired floatable coupling feature.

The adapter26comprises a first coupling part34for attaching to the body-fitment coupling part32, as a first ostomy coupling42. The adapter26further comprises a second coupling part36for releasable attachment to the appliance coupling part38, as a second ostomy coupling44. The adapter26further comprises a flexible collar40for permitting the second coupling part36to move, or “float” with respect to the first coupling part34. The flexible collar40extends at least partly between the first and second coupling parts34,36. The flexible collar40, and the first and second coupling parts34,36generally have a closed loop shape, such as round annular or tubular, around a through passage37for a stoma or stomal effluent.

In the present embodiment, the flexible collar40is a separate member that is permanently secured to the first and second coupling parts34,36by any suitable manner, such as welding or adhesive bonding. However, the flexible collar40could be integrally molded with one or both of the first and second coupling parts34,36, if desired.

The flexible collar40may have any suitable form such as comprising one or more of: stretchable material; foamed material, flat sheet material; flexible film; and/or material formed with accordion folds.

The coupling parts34,36,38are depicted schematically inFIGS. 2 and 3by blocks. However, it will be appreciated that the coupling parts34,36,38may have different shapes, such as thin, or three-dimensional profiles. The first and second couplings42,44may both be of a mechanical type, using mechanical interlock or interference to secure the respective coupling parts together. The later embodiments illustrate a mechanical coupling in which mutual interlock or interference is produced between the coupling parts34,36,38. Alternatively, the first and second couplings42,44may both be of an adhesive type, in which one or both of the confronting coupling parts34,36,38carries an adhesive for adhering to the complementary confronting part. The other confronting part may also be adhesive, or it may be a planar non-adhesive landing surface for engaging the adhesive coupling part. Alternatively, one of the first and second couplings42,44may be of an adhesive type, and the other may be of a mechanical type.

The first coupling part34may optionally be of an equivalent coupling type to the appliance coupling part38(except that the sizes of the coupling parts may be different). The second coupling part36may optionally be of an equivalent coupling type to the body fitment coupling part32(except that the sizes of the coupling parts may be different).

At least the second coupling44is of a releasably attachable type to permit fitting, detachment and renewal of an ostomy appliance24. The first coupling42may also be of a releasably attachable type in order to allow the adapter26to be removed from the body fitment22after first fitting, e.g., to facilitate cleaning or to enable the same adapter26to be used multiple times with different body fitments22. Alternatively, the first ostomy coupling42may be of a type that is non-releasable (or at least less-easily releasable) in order to prevent accidental detachment of the adapter26after it is first fitted to the body fitment22. For example, when the first ostomy coupling42is of an adhesive type, it is preferred that the first ostomy coupling42be a releasably attachable coupling, for example, comprising a peelable-resealable adhesive, such as an acrylate-based peelable-resealable adhesive. When the first ostomy coupling42is of a mechanical type, the first ostomy coupling42may be a releasably attachable coupling, or a non-releasably attachable coupling.

In use, the adapter26is first attached to the body fitment22by means of the first ostomy coupling42. It is preferred that the adapter26be attached to the body fitment22before the body fitment22is then attached to the body, in order to avoid the attachment force when fitting the adapter26causing any discomfort to the ostomate. However, the adapter26is versatile enough to be fitted to the body fitment22while the body fitment22is already adhered to the body, if so desired.

Referring toFIG. 3, in order to attach the ostomy appliance24, the ostomate displaces the second coupling part36in a direction away from the body fitment22, in order to provide space46between the second coupling part36and the body fitment22for the ostomate to insert one or more fingers48of one or both hands. Although only one finger48is shown at one position inFIG. 3, it will be appreciated that the ostomate may insert his fingers at several points to brace the second coupling part36around its periphery. Then, using the fingers48to brace the second coupling part36against the attachment force, the ostomate presses appliance coupling part38into engagement with the second coupling part36, in order to secure the ostomy appliance24to the adapter26. The ostomate then removes the fingers48, allowing the second coupling part34to return towards the body fitment22.

The transverse dimension (e.g., diameter) of the second coupling part36is generally not less than that of the first coupling part34. In the illustrated form, the second coupling part36has a larger internal dimension (e.g. internal diameter) than the outer dimension (e.g. outer diameter) of the first coupling part34. This permits the second coupling part36to fit at least partly around the first coupling part34, such that the adapter26can adopt a generally planar, low profile configuration, if desired. Referring toFIG. 2, in the generally planar configuration, the rear36aof the second coupling part36may be not substantially further from the surface of the adhesive wafer28than is the front34bof the first coupling part34. In a preferred form, the rear36aof the second coupling part may be closer to the surface of the adhesive wafer28than is the front34aof the first coupling part34, such that the two coupling parts34,36partly overlap. In an even more preferred form, the rear36aof the second coupling part36may touch the adhesive wafer28(or is backing). The profile height of the body fitment22with the adapter26can be generally the same as, or not significantly greater than, that of the body fitment22alone.

The first and second coupling parts34,36can be selected so as to match different sizes from a manufacturer's existing range of coupling sizes. For example: the first coupling part34may be a 45 mm diameter size, to fit a body fitment with a 45 mm coupling part; the second coupling part36may be a 57 mm diameter size, to fit an appliance with a 57 mm coupling part. Although the size of the appliance coupling part38does not match the size of the body fitment coupling part32, the two sizes may nevertheless be selected from the range of standard sizes of a manufacturer's existing range of products, so that no extra manufacturing burden is placed on the manufacturer.

In an alternative modification (described later with respect toFIGS. 9 and 10), the first and second coupling parts34,36may be of substantially the same coupling size, such that the coupling parts34,36sit back to back. Such a design might not provide for the same degree of low profile as the nested design ofFIGS. 2 and 3, but may enable the adapter26to be used as an option between a body fitment22and an ostomy appliance24having matching coupling sizes.

The adapter26may be used with a single body fitment22. For example, the adapter26may have a rated life equivalent to that of the body fitment22. Alternatively, the adapter26may be intended to be used multiple times with different body fitments22. The adapter26may be configured to withstand a greater number of “flexes” of the flexible collar40without plastic deformation, and to withstand cleaning between different uses.

A range of different adapters26may be provided, for example, having different throw lengths and/or different stiffnesses of the flexible collar40. This may further enhance the versatility that the adapter26can provide to a standard body fitment22.

FIGS. 4 and 5illustrate in more detail a second embodiment of the adapter26. In the second embodiment, the first coupling part34comprises an annular channel50for forming an interlocking press-fit with a complementary annular rib (not shown) of the body fitment coupling part32. The annular channel50may include one or more undercut projections53for forming the interlocking engagement, in a similar manner to that described in the aforementioned GB-A-1571657. The second coupling part36comprises a radially projecting flange52from which projects an annular rib54for forming an interlocking press-fit with a complementary annular channel of the appliance coupling part38. The annular rib54may include an undercut projection55for forming the interlock and/or a sealing wiper (not shown), both as described in GB-A-1571657. The flange52acts as: (i) a finger grip for allowing an ostomate to displace the second coupling part36axially away from the first coupling part34(as inFIG. 5), in order to generate the space46; and (ii) as a wall behind which the ostomate's fingers48can locate to brace the second coupling part36against the attachment force. The coupling parts34,36are molded from plastics material that is stiffly flexible, having a self-supporting shape.

The flexible collar40comprises a plastics film, such as ethylene-vinyl acetate, with a thickness of about 0.25 mm. The plastics film is molded or formed in a cone shape as illustrated inFIG. 5to suit the distended shape of the flexible collar40, and may collapse into a folded shape as illustrated inFIG. 4, when the flexible collar40is collapsed. The plastics film may have bistable properties, such that the flexible collar40tends to return to either of the shapes ofFIGS. 4 and 5, as is described in more detail in our concurrently filed PCT application derived from U.S. Provisional Application Nos. 60/968,403 and 60/956,238. The flexible collar40may be secured to the first and second coupling parts34,36by, for example, welding or adhesive bonding.

FIG. 6illustrates a third embodiment of the adapter26similar to the second embodiment. The main difference is that the film of the flexible collar40is formed in a generally planar shape. The flexibility of the film allows the second coupling part36to be displaced forward of the first coupling part34, to create the space46for the user's fingers. The film may be resiliently stretchable, or it may be non-stretchable.

FIGS. 7 and 8illustrate a fourth embodiment of the adapter26similar to the second embodiment. The main difference is that the flexible collar40comprises a molded plastics member60, with accordion folds62to make the flexible collar40more supple and permit the flexible collar40to distend to a cone shape (FIG. 8). The plastics member60may be molded in a generally planar shape (FIG. 7), and be resiliently deformable to the distended cone shape (FIG. 8). A suitable plastics is a polyethylene blend and the member may have a thickness of about 0.25 mm. The plastics member60may be a separate piece that is secured to the first and second coupling parts34,36by, for example, welding or bonding. Alternatively, the plastics member60may be integrally molded with one or both of the first and second coupling parts34,36.

FIGS. 9 and 10illustrate a fifth embodiment similar to the preceding embodiments except that, in the fifth embodiment, the flexible support collar40extends between coupling parts of substantially the same diameter. The flexible support collar40comprises a first end70secured to the first coupling part34, and a second end72secured to the second coupling part36. The first and second ends70,72are of substantially the same diameter, thereby enabling the adapter26to fit between a body fitment22and an ostomy appliance24having coupling parts of matching size. This is advantageous by providing fully compliant modularity, using existing ostomy components of matching size. A user can choose selectively whether to attach the ostomy appliance24directly to the body fitment22, or whether to employ the adapter26(for example, for post-operative or other special care when the stoma is particularly sensitive).

The flexible support collar40of the fifth embodiment can take a variety of forms. In one form as illustrated, the flexible support collar40is generally tubular, forming an extended tube when in the extended condition (FIG. 10), and a concertina-folded O-ring when in the retracted condition (FIG. 19). The flexible support collar40may be molded in one condition (such as the retracted condition), and be extendable to the other position. Other possible shapes and forms of the flexible support collar40are possible, such as folding and/or stretchable, referring to the possibilities aforementioned. Optionally, the flexible support collar40may have bistable properties, as is described in more detail in our concurrently filed PCT application derived from U.S. Provisional Application Nos. 60/968,403 and 60/956,238.

The flexible support40is shaped so that, in the retracted position, the flexible support collar40does not substantially obstruct back-to-back positioning of the coupling parts34and36of the adapter26(seeFIG. 9). This permits the adapter26to adopt a low-profile shape in the retracted condition, so as limit the extent to which the adapter26adds to the profile of the ostomy appliance24and the body fitment22in use. It will be appreciated that the ends of the tubular support collar40may be attached to the back-to-back faces of the coupling parts34,36, but this does not significantly space the coupling parts34,36from each other in the retracted position.

It will be appreciated that modifications, improvements and equivalents may fall within the scope of the invention as claimed.