Two-pouch ostomy appliances are disclosed, for example, in U.S. Pat. Nos. 3,089,493 and 4,826,495 and in published British applications GB 2,273,052A and 2,290,712A. A main purpose for such a two-piece system is to provide an inner pouch that is toilet-disposable, that is, one which may be discarded into the water of a toilet bowl and is capable of being flushed away without obstructing or damaging the sewer lines. Such a pouch should be degradable and, as disclosed in the art, may even be made dissolvable or disintegratable in the turbulent water of a flush toilet.
The outer pouch may be reusable and need not be toilet-disposable. Since it does not directly receive waste material (but only surrounds the inner pouch which in turn collects such material), the outer pouch, if it is not reused, may be conveniently discarded in any suitable waste receptacle.
The materials from which inner pouches had been formed in the past may or may not be gas permeable, but such materials are generally regarded as poor odor barriers. In any event, to prevent such an inner pouch from inflating in use because of flatus gasses, even an inner pouch formed of gas-impermiable material should be provided with venting means. To avoid compromising the flushability of the inner pouch, such venting means should not include a deodorizing gas filter even in those constructions in which an inner pouch is formed of an inner pouch having odor barrier properties. On the other hand, the non-flushable outer pouches of a two-pouch appliance would normally be formed of a material having odor barrier properties and also having a gas filter capable of deodorizing gasses escaping from the appliance.
Such a two-pouch system generally requires that the pouches be connected in use but separable from each other when the inner pouch is to be discarded into a flush toilet. In British application GB 2,273,052A, the two pouches are joined to the same annular adhesive flange that secures the appliance to the peristomal skin surfaces of a patient and, hence, the pouches are secured together in the region of the stoma-receiving orifice of the flange. Means are disclosed for making the attachment between the flange and the outer pouch a disruptable one. The published British application describes and shows (FIG. 6) that the outer pouch may be detached from the flange and drawn away from the inner pouch while the latter remains adhesively secured to the patient.
As a practical matter, efforts to remove an outer pouch while an inner pouch remains in place might be a difficult and possibly messy procedure. The force required to disconnect an outer pouch from the flange might also result in detaching the flange from the patient, preventing separation of the two pouches in the manner described in the patent and possibly resulting in leakage and loss of control over both pouches. Perhaps for those reasons, the patentee instructs users to follow a different procedure in the marketing of its commercial product. Specifically, the instructional literature accompanying the commercial product disclosed in this published application directs users to remove both pouches at the same time by peeling the adhesive flange (wafer) away from the skin and only then, after both pouches are removed, to proceed with separation of the pouches. Even then, such separation may be difficult and messy since a user is instructed to break the attachment between the adhesive flange and the outer pouch by gripping the outer pouch and exerting a sharp outward movement to free the outer pouch from the flange. If successfully done, that leaves the outer pouch with a torn opening that approximates the size of the flange (to which it is no longer connected) and the user must then extract the inner pouch and its contents through the torn opening in the outer pouch.
A main aspect of this invention is to provide a two-pouch system that is more user-friendly and does not require a user to disconnect the inner and outer pouches from each other in the region of a stoma-receiving orifice as a prerequisite to separation of the pouches from each other. In a removal operation utilizing the system of this invention, a user simply tears open an enlarged flap on the obverse or front wall of the outer pouch (preferably while both pouches are still being worn), peels an adhesive attachment flange exclusively for the inner pouch away from the skin, and then grips the inner pouch and tears it free along a tear line extending along its upper margin (or its upper side margins), drawing the inner pouch out of the outer pouch through the enlarged flap opening formed in the latter. After discharging the inner pouch and its contents into a flush toilet, a user then removes the outer pouch from its adhesive attachment to the skin.
An important feature permitting such user-friendly operation is the fact that the two pouches are not connected to each other about the stoma-receiving orifice. In contrast to the prior art systems, each pouch has its own annular adhesive attachment flange or wafer, and the two flanges are not connected in use. The inner pouch has a first flange externally secured thereto about the orifice in its bodyside wall, and the outer pouch has a second adhesive flange secured to its bodyside wall and extending about, and spaced from, the first adhesive flange of the inner pouch. Therefore, the smaller annular flange of the inner pouch may be easily peeled away from the skin without resistance from the larger flange of the outer pouch which most advantageously remains attached to the skin for later removal.
Briefly, the ostomy appliance of this invention includes an inner pouch having a bodyside wall with a stoma-receiving orifice in that wall. An outer pouch surrounds the inner pouch and also has a bodyside wall with an opening that is generally concentric with and substantially larger than the orifice of the inner pouch. The inner pouch has a upper marginal portion that is disposed between and sealed (thermally or adhesively) to the upper edge portions of the bodyside wall and obverse wall of the outer pouch, with the upper marginal portion of the inner pouch having a sealed lower section that is located below the seal between the marginal portion and the walls of the outer pouch. A tear line extends across the the upper marginal portion of the inner pouch and, since the upper marginal portion is the only connection between the two pouches, separation along that tear line disconnects the pouches from each other.
Means are provided by the obverse wall of the outer pouch for accessing and extracting the inner pouch. In a preferred embodiment, such means takes the form of a flap portion at least partially defined by downwardly and outwardly diverging lines of weakness formed in the obverse wall of the pouch. The flap portion may be generally triangular in shape, and gripping means may be provided at the upper apex of the triangle to facilitate execution of the downward and outward tearing operation when access and removal of the inner pouch are desired.
Other features, advantages and objects of the invention will become apparent from the specification and drawings.
USPTO Backgrounds
USPTO Backgrounds