Ostomy coupling

Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...

Reexamination Certificate

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Reexamination Certificate

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06537261

ABSTRACT:

This invention relates to the field of ostomy products, and in particular to a coupling for releasably attaching an ostomy pouch to a pad or wafer worn on the body. The term “ostomy” is intended to be interpreted broadly, and includes colostomy, urostomy and ileostomy.
FLUSH FIT COUPLING
In one form, the invention relates to a so-called two-piece coupling consisting substantially of only two coupling members, one for the bag side of the coupling and the other for the body side.
There are many different designs of two-piece coupling. Typically, the mutually engaging regions of the bodyside and bagside coupling members result in a deadspace being created between the pouch and the body pad or wafer; in other words, the pouch is held away from the pad by a distance corresponding to the “height” of the coupling. Generally, it is desired that the coupling members have a low profile, so as to keep the deadspace to a minimum.
A coupling has been proposed in U.S. Pat No. 4,872,869 in which the ostomy pouch is a flush fit, or almost a flush fit, against the body pad. Such an arrangement is referred to herein as a flush-fit coupling.
Broadly speaking, in a first aspect, the invention provides a flush-fit coupling including a bagside coupling member and a bodyside coupling member securable together.
The coupling preferably has one or more of the following features:
1. The bagside coupling member includes an inner first wall, and an outer second wall defining a connection channel therebetween, and of the first and second walls, one of said walls comprises or carries a locking projection facing the interior of the channel, the surface of the other wall facing the channel being a generally smooth sealing surface.
Such an arrangement can provide significant technical advantages, over the prior art.
In particular, the coupling described in the aforementioned U.S. Pat. No. 4,872,869, relies on locking profiles on both of the cylindrical walls defining the channel of the bagside coupling member. The locking profiles act in combination with a central rib, to trap the connecting part of the bodyside member in the channel. The interlocking regions have a dual function in providing a seal and a secure fastening.
However, in developing the present invention, it was appreciated that a user may have severe problems trying to release the aforementioned prior art coupling to separate an ostomy pouch from the body part after use. The problem arises because the connecting part of the bodyside member is interlocked by both the channel walls, and is also expanded by the rib in the channel. This can make it virtually impossible to withdraw the connecting part from the channel, without twisting or deforming the channel somehow. The above problem is magnified by the coupling being recessed inside the pouch. Even flexing of the front flange of the bagside coupling member would provide little assistance to releasing both channel walls, since the recessed design of the coupling member means that the front flange is not coupled directly to the base of the channel.
Such a coupling thus requires considerable dexterity to release, and would provide problems for many ostomates, who are often elderly and may not have much strength in their fingers.
However, with the present invention, by providing different wall portions to provide a sealing function (i.e. either the inner, first wall, or the outer, second wall) and a locking function (i.e. either the outer, second wall, or the inner, first wall, respectively), many of the above problems can be avoided. The coupling can be made much easier to release without having to weaken the seal, and without having to weaken the security of the coupling.
Preferably, the wall carrying the locking projection carries a plurality of locking projections. For example, the locking projections may be spaced apart angularly.
In a closely related specific aspect, the invention provides a flush fit ostomy coupling, comprising:
a bagside coupling member comprising an inner first wall and an outer second wall defining a channel therebetween, a mounting flange extending outwardly from the second wall at the mouth of the channel, one of the first and second walls comprising at least one locking projection facing the first wall;
a bodyside coupling member comprising a projection which, in use, is received within the channel of the bagside coupling member, the projection including a formation for interlocking engagement with the locking projection of one of said walls of the bagside coupling member, and a deflectable seal for non-interlocking engagement with the other wall of the bagside coupling member.
2. The bagside coupling member is secured to an ostomy pouch comprising first and second pouch walls and having an entrance aperture in the first pouch wall, the bagside coupling member being carried by the first pouch wall at the aperture, at least a portion of the bagside coupling member extending inside the pouch. Anti-sealing means is provided for preventing in use sealing between a portion of the bagside coupling member and the interior face of the second pouch wall.
This feature of the invention can avoid the potential problem of, for example, the front wall of the pouch opposite the coupling member tending to stick to the coupling member when the pouch is first used. This effect is similar to the problem of pancaking in which the front and rear walls of the pouch can sometimes stick together, and obstruct the entry of body waste into the pouch. The use of a coupling member extending at least partly inside the pouch can actually reduce the effect of direct pancaking between the front and rear walls at the aperture (by holding the walls apart to some extent), but there is then the potential problem of the pouch wall tending to seal or stick to the coupling member, which again would obstruct entry of body waste into the pouch. However, by using anti-sealing means in accordance with this aspect of the invention, this potential problem can be avoided or at least reduced.
The anti-sealing means may comprise a non-planar surface of the coupling member, for example, one or more projections or recesses, or an undulating surface, to promote channels or spaces being created between the coupling member surface and the opposing face of the pouch wall. Alternatively, the anti-sealing means may comprise a non-stick coating carried by the coupling member and/or by the pouch wall.
In a closely related specific aspect, the invention provides a bagside coupling member for a flush fit coupling, the bagside coupling member comprising a coupling channel, and anti-sealing means on the rear surface of the channel.
3. The bagside coupling member is carried by an ostomy pouch comprising first and second pouch walls, there being an entrance aperture in the first pouch wall, the bagside coupling member being carried by the first pouch wall at the aperture, at least a portion of the bagside coupling member extending inside the pouch, and a surface of the bagside coupling member confronting the second wall being substantially non-planar.
In addition to any non-sealing effect, this feature can improve the extent to which a user is able to feel by hand the profile of coupling member through the pouch wall material, to enable the user better to position his hands during fitting of the pouch to the body, and during removal of the pouch from the body. During the development of the present invention, it has been appreciated that the recessed nature of the “flush-fit” bagside coupling member results in the coupling being considerably more hidden from the user's view. This loss of visibility can make the coupling more difficult to fit and remove. Therefore, improving the tactility of the coupling through the second pouch wall can compensate for loss of visibility of the coupling member.
In one preferred embodiment, the surface comprises a plurality of spaced apart projections, for example, small domes. In another embodiment, the surface comprises an annular projection.
In a closely related specific aspect, the invention pr

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