SEALED COUPLING DEVICE FOR OSTOMY

Abstract: The device object of the present invention relates to a sealed coupling for ostomy, of the type applicable in closing systems and which includes a collecting bag provided with a central orifice which may be brought face to face to a stoma and surrounded by an annular coupling element joined to the wall of said bag, which coupling element has a double wall defining a channel with its opening oriented towards the stoma, and which cooperates with a second annular coupling element integral with a plate adhered to the skin of the user around the stoma, allowing a coupling/uncoupling as desired by the user. To this effect, there is provided an annular tubular neck adhered to the user's skin coupled in a conduit defined by an also annular double wall joined around the stoma-facing orifice of the collecting bag.

Description: The present invention relates to a sealed coupling device for ostomy. AREA OF THE INVENTION As is known, in some gastrointestinal or urinary surgical operations the patients have artificial openings made to which bags for receiving the residues are connected. These artificial openings are known as colostomies, urostomies or ileostomies, commonly designated by the term ostomy. The device of this invention relates to a sealed coupling for ostomy, of the type applicable in assemblies for ostomy which comprise a collecting bag with a central orifice, juxtaposed to a stoma and surrounded by an annular coupling element connected to the wall of said bag, which element has a double wall defining a channel with its opening oriented toward the stoma, which cooperates with a second annular coupling element integral with a plate adhering to the user's skin around the stoma, permitting very simple and convenient coupling/uncoupling at the user's discretion. HISTORY OF THE INVENTION The collecting ostomy bags and the accessories attached to them are preferably made of plastic materials, in view of their flexible and impermeable characteristics, among others. The closure systems formed by obturation elements in the form of male and female ribs, both of plastic, capable of nesting one in the other offering an efficient closure and facilitating the opening of flexible bags generally of plastic material, are known and widely used in a variety of industrial sectors. These types of closure systems are fully described by KABUSHIKI KAISHA SEISAN NIPPON-SHA, contained in Spanish Patents No. 279,517 of 1962 and Certificate of Addition No. 332,468 of 1966, and by MINIGRIF EUROPE AKTIESELSKAB contained in Spanish Patent No. 330,627 of 1967. More concrete antecedents of the present invention in the sector where the latter applies are in the first place German patent No. 2,812,833 and in particular the embodiment thereof which is covered in Spanish Utility Model No. 238,930 and French patent FR-A-2548890 (embodiments of figures 1 to 8). Said patent concerns a device of the cited type which comprises two semirigid annular coupling elements, one joined to the plate which in turn adheres to the user's skin in the zone surrounding the stoma, and the second annular element fastened to a collecting bag, adopting a transverse section which defines a channel with its orifice oriented toward the stoma and with a projection on its outer wall which cooperates in interlock with a shoulder of a tubular neck which is integral with the first-mentioned annular element, so that as the two annular elements are being coupled, the neck of the first enters into the channel of the second the inner wall of said neck having an obturation lip and providing a hermetic closure. The device referred to has a first disadvantage relating to the cleaning of the annular element connected to the plate adhering to the user, since the mentioned shutting lip defines a cavity where residues may be retained , difficult to reach, and in any event involving manipulations which add to the user's discomfort. Also, the proposed coupling can make it necessary for the user or the therapist to exert traction or apply pressure whenever the collecting bag must be replaced, causing the patient discomfort or pain, which would be desirable to eliminate. As to the imperviousness of the device it may also be objected that the same in supported exclusively by a lip defined on the element integral with the plate or patch adhering to the user and which is not changed every time the collecting bag is replaced, for which reason said lip may in time lose its effectiveness, with the possible deposition of residues in the concavity that it defines, as emphasized above. A second antecedent of the invention can be found in USA patent 4,419,100, in which is discussed at length the problem of the necessary rigidity of the tubular neck combined with the flexible properties of the annular coupling elements necessary for simplifying and facilitating the tasks of replacement of the bag. In this solution the risk exists of possible depositions of residues inside the channel which receives the tubular neck, thereby complicating the task of replacing the bag. Also the cost of this second device is considerable in view of the manner of connecting the second coupling element to the plate adhering to the patient. Lastly, the walls of the channel of the annular coupling element which receives inserted the tubular neck of the other annular coupling element have an equal or equivalent width, so that the free passage of the opening toward the bag is reduced and the end of the inner wall forms a stepped connection which may favour the deposit of residues. DESCRIPTION OF THE INVENTION The coupling device according to the present invention eliminates the disadvantages pointed out, giving a remarkable imperviousness between the two closure elements of male and female configuration that form it. For this there has been provided an annular element in the form of a tubular neck of predetermined cross section, integral with the plate adhering to the user's skin, which tubular neck will be coupled on a channel defined by a double wall, also annular, integrally linked around the orifice juxtaposed to the stoma of the collecting bag. Said tubular neck possesses an inverted truncated cone-shaped inner surface, with no sealing or shutting lip defining a cavity where residues may be retained, its wall presenting a maximum width at the interlocking zone and its outer face defines a protuberant profile having its base outwardly extended by a first laminar flap of flexible condition, and inwardly prolonged by a second laminar flap. The annular element which forms said channel connected to the wall of the collecting bag, around the orifice thereof facing the stoma, has a rectangular trapezoidal cross-section, with a constriction in its mouth caused by an inward protuberance of the channel, at the edge of the outer wall, which is substantially rigid, with an annular recess in its outer face, while the second wall limiting the channel is thin and flexible so that it can easily adapt to the inverted truncated cone-shaped inner face of the tubular neck of the second coupling element, without formation of a step on the corresponding end edge. The coupling between the two annular elements occurs by means of the fitting of the tubular neck against the bottom of the annular channel, offering imperviousness in at least three differentiated annular zones of the inner surface of the annular channel - a first one at the end of the thin and flexible inner wall of the annular channel by slight deformation against the lower end of the first inclined section of the tubular neck; a second one by juxtaposition of the distal planar surface of the tubular neck, parallel to the base thereof, against the bottom of the annular channel; and a third one by coincidence of the protuberance of the outer wall of the tubular neck defined by the triangular profile against the protuberance of the end of the outer wall of the annular channel. The solution according to the present invention offers optimum results, mainly by its tightness, easy handling and cleaning, as compared with the solutions know until now. In fact, the coupling between the two annular elements occurs with slight pressure, thereby obtaining absolute tightness to the exterior, through the means which bring about said union, and ensuring rapid passage of the stools between the interior of the user's stoma and the interior of the bag. The inclination of the first section of the interior of the tubular neck in juxtaposition with the end of the inner wall of one of the two walls which form the annular channel makes it easy for the stools to get quickly into the interior of the bag. Also, the described structure does not permit the settling of the stools in this intermediate section. The materials which constitute the rings referred to, as well as the bag itself, ensure an elastic deformation necessary for the user's comfort, without thereby altering the stated characteristics. Besides the foregoing elements, the device comprises others which will be pointed out below. BRIEF DESCRIPTION OF THE DRAWINGS The annexed drawings, given only by way of example, will help to better understand the invention, the characteristics which it presents, and the advantages that it is able to offer. Figure 1 is a view in transverse section of a device according to the present invention, with the two annular elements coupled. Figure 2 is a plan view of the collecting bag provided with the annular channel. Figure 3 is a sectional view of the annular channel cooperating with the tubular neck during the phase of installation of the bag connected to the tubular neck. Figure 4 is a sectional view of the annular channel with the tubular neck uncoupled. DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION In figure 1 is shown a coupling device according to the present invention, formed by the collecting bag 1 and the plate 2, both provided with the orifices 3 and 4 juxtaposable to the patient's stoma. The collecting bag 1 is formed by two identical flexible sheets, perimetrically heat-sealable at 7, the inner sheet 6 comprising the orifice 3 which connects it with its interior. Plate 2 is formed by a first conventional ring 8, of a material known commercially in the sector as 'karaya' of therapeutic characteristics, extraneous to the present invention. This ring is covered by a second ring 9 of larger diameter of a cellulose material which on its inner face comprises an adhesive, protected by the ring 10 of paper or the like, for its adhesion on the surface of the patient's skin that surrounds the stoma thereof. The materials that constitute the bag 1 are of plastic nature and laminar condition, such as polyethylene, PVC, polyamide or the like, or a compound of the type formed by polyethylene/EVA/polyvinyl chloride or similar. The collecting bag 1 is coupled to plate 2 through the channel 26 of a first annular coupling element 11 and the tubular neck 12 pertaining to a second annular coupling element 27. Both said coupling elements 11 and 27 may be made of high or low density polyethylene or of ethylene and vinyl acetate copolymer (EVA) or polyvinyl chloride (PVC), and obtained by molding. The orifice 3 provided in the collecting bag 1 is of a diameter equal to or greater than the orifice defined by the annular channel 26, as long as the contour of the orifice of sheet 6 can be joined with the basal surface 14 of the annular channel 26 integrally in conventional manner by heat. The tubular neck 12 presents in its basal zone and oriented inwardly a flexible flap 15 which in turn defines a central orifice 16 facing the orifice 4 provided in the annular plate 8. The union between the tubular neck 12 and plate 2 is obtained by heat between the end of the inner flap 15 of the tubular neck 12 and the inner perimeter of ring 9, being joined to the annular plate 8 by the previously mentioned means. From the base of the tubular neck 12 originates outwardly a laminar flap 17, the usefulness of which will be explained later. The tubular neck 12 itself has a continuous general cross section comprising the inclined profile of the inner flap 15 followed by a first inclined section 18, a second section 19 parallel to the base of the tubular neck 12, followed by a triangular profile 20, and ending in a section 21 substantially perpendicular to the base which extends outwardly through the laminar flap 17. The annular channel 26 connected by the surface 14 to the sheet 6 of the collecting bag 1 is turned toward the stoma of the patient, presenting in section, its substantially rigid outer wall 22 and with an annular recess in its outer face of rectangular section 23, and its much thinner inner wall 24, of triangular profile inverted from the surface 14, slightly protruding relative to the outer wall 22. Internally, the annular channel 26 comprises on the outer wall 22 a protuberance 25 at its lower end, the usefulness of which will be described later. Externally, the annular channel 26 is provided with a flap 30, as shown in figure 4, the usefulness of which will be described later. The coupling between the annular channel 26 and the tubular neck 12 is obtained by means of the insertion of the former against the latter, as shown in figure 3. The annular plate 8 will place itself around the patient's stoma and will stay connected therewith by means of the ring 9 adhering on the patient's skin, allowing the tubular neck 12 to be positioned reliably. As the tubular neck 12 is connected to the ring 9 by the end of the inner flap 15, and as the materials that constitute the parts are flexible, the user's thumb can be positioned between the outer laminar flap 17 of the tubular neck 12 and the adhesive ring 9, as shown in figure 3. By its free end, the tubular neck 12 is able to receive the bottom of the annular channel 26 and by slight pressure between both parts through the positioning referred to, with the index finger of the same hand on the outer face of the bag against the base surface 14 of the first coupling element 11, almost without exerting force on plate 8 and the peristomal zone. The coupling between the two annular elements receives an imperviousness in three differentiated annular zones: A first one between the end of the triangular thin and flexible inner wall 24 of delimiting the annular channel 26, superimposed by slight deformation on the first inclined section 18 of the tubular neck. A second zone by juxtaposition of the section 19 parallel to the base of the tubular neck 12 against the inner bottom of the annular channel 26, and A third and last zone through the protuberance 25 of the inner lower end of the outer wall of the annular channel 26, with the outer triangular projection 20 of the tubular neck 12. Figure 4 shows how to proceed for the uncoupling between the annular channel 26 and the tubular neck 12. Thus, by slight pressure outward with the fingers of one hand through flap 30 of annular channel 26, and pressing the fingers of the other hand on the surface of the outer laminar flap 17 of the tubular neck 12, it is feasible to release, by deformation, the protuberance 25 of the inner lower end of the outer wall of the annular channel 26 from the outer triangular projection 20 of the tubular neck 12. With the coupling of the two annular elements, the inclination of the inner triangular wall 24 delimiting the annular channel 26, adapted by slight deformation on the first inner inclined section 18 of inverted truncated cone shape of the tubular neck 12 cooperates definitively to ensure the tightness of the assembly, as it not only does not permit the deposit of the stools on the same distance existing between the end of that inclined section and the small angle defined by the first inclined inner section 18 and the inner flap 15 of the tubular neck 12, but it effectively helps due to its inclination the path of the stools toward the interior of the collecting bag 1.

Claims: Sealed coupling device for ostomy, of the type applicable in closure systems which comprise a collecting bag (1), with an orifice (3) facing a patient's stoma surrounded by a first annular coupling element (11) connected to a wall (6) of said bag, said element (11) having a double wall which provides a channel (26) with its entrance facing the stoma and an inwardly oriented projection (25) of its outer wall cooperating with a protuberance of a tubular neck (12) pertaining to a second annular coupling element (27) in order to interlock both coupling elements (11), (27), said second annular coupling element being fastened to a plate (2) adhering to the user's skin around a stoma, the coupling between the two annular elements (11), (27) being executed by introduction of said tubular neck (12) provided with a sealing or shutting flexible lip into said channel (26), characterized in that the inner wall of the tubular neck (12) has no sealing or shutting lip defining a cavity where residues may be retained, said tubular neck (12) possessing an inverted frustum-cone shaped inner surface (18), and its wall having a maximum width at the interlocking zone at which area a protuberant profile (20) extends its outer face, the base of said tubular neck being outwardly extended by a first laminar flap (17) of flexible condition and inwardly prolonged by a second laminar flap (15) whereby said second annular coupling element (27) is attached to the plate (2) and in that the inner wall (24) of said first annular coupling element (11) delimiting the channel (26) is thin and flexible so that it can, with slight deformation, easily adapt superimposed on the inverted frustum-conical shaped inner face (18) of the tubular neck (12) of the second coupling element (27) providing a first imperviousness area, while a second obturation zone is obtained by the juxtaposition of the distal surface (19) of said tubular neck (12) against the bottom of said channel (26) and a third hermetic closure is obtained by the protuberant profile (20) of the outer wall of said tubular neck (12) laying under the projection (25) of the end of the outer wall (22) of said channel (26) due to the groove-and-tongue coupling between the two annular coupling elements (11), (27). Device according to claim 1, characterized in that the wall of the tubular neck (12) of said second annular coupling element (27) offers in cross section a first inclined portion corresponding to the inverted frustum-conical shaped inner surface (18), continued by a second portion pertaining to a planar surface (19) parallel to the base (13) of the element, followed by a triangular profile whose vertex defines said protuberance (20) providing an interlock between coupling elements (11) and (27), and ending in a last portion (21) substantially perpendicular to the base (13) which connects with the inner edge of the flexible annular flap (17) extending outwardly. Device, according to claim 1, characterized in that said first annular coupling element (11) connected to the wall (6) of the collecting bag (1) delimiting the orifice (3) thereof facing the stoma has a substantially rigid outer wall (22) and an annular groove (23) in its outer face of rectangular cross section. Device, according to claim 3, characterized in that said thin and flexible inner wall (24) of said first annular coupling element (11) has a triangular transversal cross section and a greater development in length than the outer wall (22). Device, according to claims 3, characterized in that the inner section of said channel (26) of said first annular coupling element (11) connected to the wall (6) of the collecting bag (1) has a rectangular trapezoidal cross profile. Device, according to claim 1, characterized in that said first laminar flap (17) which extends outwardly from the base (13) of said second annular coupling element (27) evolves as a circular rim and it extends above the plate (2) in a zone next to the edges thereof. Device, according to claim 1, characterized in that said second laminar flap (15) extending inwardly from the base (13) of said second annular coupling element (27) also evolves as a circular rim having a smaller thickness and width than said first laminar flap (17). Device, according to claim 1, characterized in that said inwardly extending second laminar flap (15) is nearer to the plate (2) than said outwardly extending first laminar flap (17).

Inventors: PASCUAL VIDAL JOSE MARIA, PASCUAL VIDAL, JOSE, MARIA, PASCUAL VIDAL, José, Maria
Applicants: PALEX IND SA, INDUSTRIAS PALEX, S.A.
Application year: 1990
Main classification: A61F5
IPC codes: A61F5