Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-03-10
2002-06-25
Casler, Brian L. (Department: 3763)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S338000, C604S332000
Reexamination Certificate
active
06409710
ABSTRACT:
The present invention relates to a coupling which can form part of the structure of an ostomy appliance, and also to an ostomy appliance comprising such a coupling.
A great many appliances have already been proposed for the collection of bodily matter (faeces, urine, etc.) in persons who have undergone surgery of the gastrointestinal tract, of the ileostomy or colostomy type, or surgery of the urinary tract, of the urostomy type, or surgery necessitating the drainage of wounds or of intra-abdominal cavities, of the peritoneal or sub-peritoneal drainage type. Among these appliances, a basic distinction is made between:
appliances referred to as “one-piece” appliances because they consist of a collecting bag which comprises a skin protector provided with a pressure-sensitive adhesive and which is intended to be fixed on the user's skin by way of this skin protector alone, and
appliances referred to as “two-piece” appliances which comprise a frontal sheet or “bag holder” intended to be fixed on the user's skin and provided, for this purpose, with an adhesive pad, and a collecting bag which can be removably attached to this frontal sheet by means of a joining piece with which it is provided.
The ostomy appliances of the “two-piece” type have to satisfy certain conditions, some of which are inherently contradictory. Thus, although it is essential that the fixing of the collecting bag on the bag holder is secure in such a way as to prevent any inadvertent separation of this bag, particularly under the effect of the stresses exerted by the weight of the bodily matter with which it fills, and moreover that it guarantees perfect leaktightness of the appliance in relation to this matter, it is also desirable that the ostomy patients —who are often elderly subjects can, after a period of training by nursing staff, put the bag holder in place themselves, on the one hand, and, on the other hand, place the collecting bags on the bag holder, and this means that the manoeuvres for joining and disconnecting the bag and bag holder must be as simple and straightforward as possible.
To this end, two-piece appliances have been proposed, in a great many embodiments, in which the collecting bag and the bag holder are joined together by force-fitting, under the effect of a pressure applied by the patient, a joining piece, which is equipped with an annular sealing lip and is situated preferably on the bag, into a channel which has a shape and dimensions matching those of the said joining piece and which is formed by two other joining pieces situated preferably on the bag holder. These appliances, described in GB-A-1 571 657 and EP-A-0 171 255, for example, have the advantage that a single engagement operation ensures, on the one hand, the attachment of the bag and the bag holder and, on the other hand, the leaktightness of the appliance. However, in practice, to obtain satisfactory results, these appliances demand that the patient exert a considerable pressure on the bag, when placing it on the bag holder, and, consequently, on the area surrounding the stoma, which is generally very sensitive, sometimes very painful, so that the use of these appliances is not really satisfactory.
In an attempt to solve this problem, it has been proposed in GB-A-2 237 993 and GB-A-2 237 995 to improve this type of appliance by configuring the joining pieces of the collecting bag and of the bag holder in such a way that they are joined together, no longer by force-fitting, but by the joining piece of the bag snapping between the two joining pieces of the bag holder, and in such a way that their attachment is ensured by means of the end of the annular sealing lip of the joining piece of the bag pressing against a rib, likewise annular, situated on one of the joining pieces of the bag holder. Although these appliances do indeed allow the bag and the bag holder to be joined together without exerting pressure on the area surrounding the stoma, they nevertheless pose another problem, namely that in order to disconnect them, they require that a considerable pulling force be applied on the said bag, which, once again, can cause pain on account of the sensitivity of the area surrounding the stoma, and which can also cause partial or total tearing of the bag holder from the patient's skin, rendering it unsuitable for further use.
Two-piece appliances have also been proposed in which the device for joining the collecting bag and the bag holder together comprises, on the one hand, two joining pieces, one of which is situated on the bag while the other is fixed on the bag holder and which, when they are brought into contact with one another, are intended to ensure the leaktightness of the appliance by virtue of the presence of a sealing lip or sealing joint or by virtue of the matching nature of their shapes and/or their dimensions, and, on the other hand, a member of the circular ring type which is generally connected to one of these two joining pieces and which, by different mechanisms (cam effect, clamping effect, etc.), ensures the attachment of the bag on the bag holder in such a way that these can be joined together and disconnected by means of applying moderate, if any, forces of pressure in one case and of traction in the other, on the bag. Such appliances are described in EP-A-0 255 310 and in WO-A-91/01118, for example.
The appliances of this latter type are not totally satisfactory either to the extent that, although belonging to the two-piece appliance type, they in fact comprise at least three elements for joining the collecting bag to the bag holder, a fact which significantly complicates their realization, both in terms of the manufacture of the various components from which they are made up and the assembly of these components, and substantially increases their production cost, whereas the long-term use of appliances by ostomy patients dictates that these appliances be relatively inexpensive.
Consequently, a general object of the invention is to make available an ostomy appliance in which the device for joining together and disconnecting the collecting bag and the bag holder is made up of only two elements, in such a way as to have a relatively low production cost, while at the same time satisfying all the conditions demanded of such an appliance, and, especially, ease of use, ease of handling, security of the attachment of the bag on the bag holder and leaktightness in relation to the bodily matter, and which not only permits positioning of the bag on the bag holder without applying pressure in the area surrounding the stoma, but also permits removal of this bag without the need to exert considerable pulling force.
It is also an object of the invention to make available such an appliance which, once the collecting bag and the bag holder have been joined together, allows the patient to modify the position of the bag in relation to the bag holder in a simple way and without risk, for example in order to adapt the orientation of the bag as a function of his/her activities or to make it easier to empty.
According to the invention, these objects are achieved by a coupling which can form part of the structure of an ostomy appliance and which comprises two elements which can be joined together removably, each including a base, equipped with a central opening, and a tubular joining piece surrounding the said opening, in which the joining piece of the first element comprises, on its internal face, an elastically deformable annular lip whose free end is directed towards the plane of the base of the said element, while the joining piece of the second element includes, on its external face, means for axial retention of the free end of this lip, which coupling is characterized in that it includes a locking member, and in that the means for axial retention of the free end of the annular lip occupy a sector of the circumference of the joining piece of the second element, of which the midpoint is situated diametrically opposite the said locking member under conditions of assembly and disassembly of the two elements
Alston & Bird LLP
B. Braun Biotrol
Thanh LoAn H.
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