FR2690333A1 - Body attachment location for colostomy bag - comprises rigid securing ring attachable around body opening, with deformable locking clip securing collar of bag aperture in fastening groove - Google Patents

Abstract

A bag-securing ring (10) is fastened around an artificial body opening, for reception of a fluid collection bag (21) with a projecting aperture collar (20). The collar of the bag includes a number of segments (25) arranged parallel to its axis of symmetry, which engage against a conical annular surface of the securing ring. The securing ring has a circumferential locking clip in the form of a slotted ring, with a closure device (41) deforming it inwardly into a circular configuration. In its closed position, the clip traps the projecting segments of the bag collar in a groove formed in the securing ring. USE/ADVANTAGE - Rapid, secure attachment of e.g. colostomy bag with reduced risk of leakage or incorrect positioning.

Description

 The present invention relates to a device for connecting a pocket and a pocket holder for an ostomy appliance.

 Many devices have already been proposed for the collection of urine or bodily waste from individuals who have undergone a surgical procedure such as an enterostomy (ileostomy, colostomy, ...) or urostomy. Among these known devices, there are those consisting of disposable bags, generally fixed directly to the skin of the user by a ring-shaped adhesive or provided with a skin protector, those known as systems. "two-piece", in which the collection pocket, -in the form of a disposable or drainable bag-, can be secured in a removable manner on a protective front plate fixed to the body of a patient by a pad provided with a adhesive or of an adhesive eraser or by a belt and, finally, those designated in practice under the name of "three-piece" systems and which differ from the preceding ones by the fact that a "third piece" is associated with the pocket holder or pocket to oppose an untimely separation of the latter with respect to the pocket holder, in particular when said pocket is partially or completely filled.

 To meet the requirements of patients, a device for connecting a pocket and a pocket holder for an ostomy appliance must satisfy imperative conditions, some of which contradict each other. It is in fact advisable that the attachment of the collection bag to a protective front plate or pocket holder can be done without applying significant pressure in the area adjacent to the stoma, which is sensitive and generally painful, and that the fixation is secure with a perfect seal of the assembly of the system while allowing an easy separation all the more important as the pouch holder remains fixed on the skin of the patient in the vicinity of the stoma for one or more days, a pocket must be secured and separated from the pocket holder several times a day.

 In an attempt to provide a solution to the problem posed, both with regard to the quality of the seal and the use of as low a pressure as possible for the attachment of the pocket to the pocket holder, has already proposed, for example in FR-A-1 566 496 or JP-U-60 158820, devices in which the means for coupling the pocket and the pocket holder comprise a collar with a frustoconical surface on the pocket holder and a frustoconical surface of conjugate shape on a ring integral with the pocket and which is designated in the art by the name of "pocket nose".

In the apparatuses according to these two patents, however, the assembly of the pocket and the pocket holder is carried out with the aid of an elastic latching with snap-on effect which requires the application of a relatively high pressure and, therefore, does not fully solve the problem. There is then a need, again, to provide a device for connecting a pocket and a pocket holder for an improved ostomy appliance which makes it possible to fulfill the various requirements of these devices.

 It is, therefore, a general object of the invention to provide such a device for connecting a pocket and a device pocket for apparatus applicable to digestive or urinary ostomies which satisfies these conditions, in which the implementation place of the pocket on the pocket holder previously fixed to the body of a patient is extremely easy, on the one hand, and is carried out, on the other hand, practically without application of pressure in the area adjacent to the stoma.

 It is also an object of the invention to provide such a device for connecting a pocket and a pouch pocket for an ostomy appliance which is very safe to use and in which, in particular, the tightness of the connection between the pocket and the pocket holder is ensured as soon as the pocket is placed on the pocket holder.

 The problem is solved, in a device for connecting a pocket and a pocket holder for an ostomy appliance comprising a pocket holder intended to be fixed to the body of a patient using a pad provided an adhesive or an adhesive gum sensitive to pressure, or by an equivalent means, as well as a bag for collecting fluids and / or bodily waste suitable for being removably assembled to the pocket holder by a nose which it has, the pocket holder comprising a collar with a frustoconical surface and the pocket nose a conjugate frustoconical part capable of cooperating with the collar by the fact that, according to the invention, the pocket nose has appendages directed parallel to its axis of symmetry and by the fact that the pocket holder comprises a lock suitable for blocking said appendages, -for fixing the pocket on the pocket holder, by trapping them in an annular groove in the pocket holder.

 In one embodiment, the lock consists of a split ring with which are associated means for deforming it and varying its length in order to urge said appendages and make them penetrate into said groove where they are blocked for fixing the pocket on the pocket holder.

 In such a device for connecting a pocket and a pocket holder for an ostomy appliance, therefore, and unlike known devices of the interlocking type, no pressure is exerted in the vicinity of the ostomy during the positioning of the pocket on the pocket holder since, during this installation, the appendages of the pocket nose are only positioned opposite the annular groove of the pocket holder, where they are then immobilized by a jamming effect when the lock is actuated, which advantageously results in a reduction in its circumferential dimension by a radial (and not axial) movement which exerts little or no pressure on the sensitive area of the patient's body surrounding the stoma .

 In a device according to the invention, in addition, the pocket nose is inside the pocket proper, so that it avoids, by association with the pocket holder, any "sticking" effect of the sheets making up the pocket, "bonding" which sometimes opposes the satisfactory disposal of bodily waste.

 According to another characteristic of the invention, the annular groove of the pocket holder is provided. between the collar with a frustoconical surface and a cylindrical part of a nozzle of which said collar is an integral part and which is erected on a support or base which also carries the pad for fixing to the patient's body.

 When the lock is a radially split ring, the invention provides, for its actuation, a lever mounted at articulation on an axis integral with the support, said lever being in one piece with the rest of the ring to which it is connected by a bit of material.

 The latter is advantageously a plastic material of the polyamide or polypropylene type to have good toughness and spring effect characteristics, while the support carrying said lock is advantageously made of high density polyethylene or polypropylene or polyamide, the pocket nose being to him in a material of the low density polyethylene type or EVA (ethylene vinyl acetate) copolymer.

 In a preferred embodiment, the lock, produced as a split ring, has a channel for receiving the appendages of the pocket nose, a channel whose initial circumferential length is substantially that of the pocket nose and whose reduction causes the trapping of the appendages in the throat of the pocket holder.

 Alternatively, the split ring is a simple band or has a cross section in L.

 According to another characteristic of the invention, studs are associated with the lock, on the face of the latter in contact with the pocket holder, one of the studs being intended to form a fixed anchor point at one end of the lock on the support and the others being able to move in the openings of the support for guiding said lock during the deformation of this by actuation of the lever.

 According to the invention, also, that of the lights of the support in which the studs are engaged which is closest to the fixed end of the lock, but on the part corresponding to the movable end of the latter, is particular shape for, when guiding the stud which is engaged therein, perfecting the shape in closed condition of said lock which is that of immobilization of the pocket nose on the pocket holder.

 In an advantageous embodiment, the bolt support has, in the vicinity of the axis of articulation of the operating lever, a notch in which is adapted to penetrate a stud of conjugate shape of the bolt to block the latter in condition of closing by a "hard point", which can however be easily crossed when the lever is actuated no longer when locking, but when unlocking the pocket nose on the pocket holder.

 So that the immobilization of the pocket nose on the pocket holder takes place satisfactorily, the invention also provides, and to ensure good deformation of the appendages which depend on the pocket nose, to conform the latter as arranged sectors. according to the circle limiting the opening presented by the pocket nose, the number of sectors being chosen as a function of the dimensions of the fitting, itself a function of those of the ostomy appliance which it equips, said sectors being preferably separated to each other by notches with a V-shaped cross section.

 The invention also relates to a bag for collecting fluids and / or bodily waste, in particular for enterostomy or urostomy suitable for entering into the constitution of a connection device as defined above and characterized in that it comprises , around an opening of one of its walls, a pocket nose directed towards the inside of the pocket, the surface of which suitable for cooperating with that of the collar of the pocket holder is a frustoconical surface and which is provided with appendages directed substantially parallel to the axis of symmetry of the nose for fixing the latter by a pocket holder lock.

 The subject of the invention is also a pocket holder suitable for entering into the constitution of a device as defined above, comprising a pad provided with an adhesive or an adhesive gum sensitive to pressure or an equivalent means. fixing on the body of a patient with a collar providing a frustoconical surface for the sealed assembly of a bag for collecting fluids and / or bodily waste and which is characterized in that an annular groove is provided under the collar receiving appendages depending on the pocket nose, and where said appendages can be trapped by a lock of modifiable length for fixing the pocket on the pocket holder.

The invention will be better understood from the description which follows, given by way of example and with reference to the appended drawing, in which
- Figure 1 is a schematic perspective view showing, distant from each other, a pocket holder and a pocket of a device according to the invention;
- Figure 2 is an elevational view of a component part of the pocket holder of a device according to the invention
- Figures 2a and 2b are sections along lines aa and bb, respectively, of Figure 2
- Figure 3 is an elevational view of a device lock according to the invention
- Figure 3a is a sectional view along line aa of Figure 3;
- Figures 3b and 3c are views similar to Figure 3 for variants;
- Figure 4 is an elevational view of a device pocket nose according to the invention;
- Figures 4a and 4b are sectional views along lines aa and bb of Figure 4, respectively while Figure 4c is a schematic view in the direction of arrow c in Figure 4;
- Figure 5 is a schematic half-view in section illustrating the relative position of a pocket and a pocket holder before respective securing
- Figure 6 is a half-view similar to that of Figure 5, but after actuation of the lock to secure the pocket and the pocket holder
- Figure 7 is a view from the rear face of a device pocket holder according to the invention.

 Reference is first made to FIG. 1 which shows a first embodiment of a device for connecting a pocket and a pocket holder for an ostomy appliance according to the invention of the type comprising a pocket holder 10 intended to be fixed around an artificial opening of the body of a patient using an appropriate fixing means, such as a pad provided with an adhesive or a pressure-sensitive adhesive gum 12, in particular itself known, and which is protected as long as the device is not used by a film 11, which can be removed by peeling; alternatively and / or additionally, the pocket holder 10 can be held on the patient's body using a not shown belt or similar means. The pocket holder 10, the pad 12 of which has an opening 13 surrounding the stoma in its condition of use, also comprises, on the face of the pad 12 opposite to that coming into contact with the patient's body, a composite sheet 14 which contributes protecting the peristomal area and keeping it on the patient's skin. On the face of the composite sheet 14 opposite to that of connection to the shoe 12 is fixed, by a base 15, a nozzle 16 of axis A comprising a cylindrical part 17 and a collar 18 whose external surface 19 is frustoconical, FIGS. 5 and 6, the space existing between the collar and the base, around the cylindrical part, forming an annular groove E. The surface 19 is provided for the sealing assembly of a pocket nose, 20, of a pocket 21 for the collection of fluids and / or bodily waste suitable for being discharged through the nozzle 16 and which may be of the type to be discarded or emptied. The pocket 21 is produced by joining, by bonding, welding or the like, the pocket nose 20 to a wall of the pocket proper consisting of a film of polyethylene or PVC, or of polyamide or of a complex barrier film of polyethylene type / EVA / polyvinylidene chloride / EVA / polyethylene, such as those known under the registered trademark SARANEX from the company DOW CHEMICAL or a complex film of the EVA type / polyvinylidene chloride-EVA copolymer, such as those known under the trademark CRYOVAC from the company GRACE and under the trademark SARANEX of the company DOW CHEMICAL or a complex film of the EVA / EVOH / EVA type, or a similar material.

 As can be clearly seen in FIGS. 1, 4, 4a, 4b, 5 and 6, the pocket nose 20 depends on the appendages 25 most simply constituted by sectors which have come from molding with the pocket nose and which protrude on the annular face. 26 frontal of this nose by being distributed regularly along the circle limiting the opening 29 of the pocket nose. The appendages 25 are advantageously connected to the pocket nose by tabs 28 whose shape and dimensions are such that they are elastically deformable when they are urged by a latch 40 which will be described below. In a preferred embodiment, the sectors 25 are separated by slots 27 with a V-shaped cross section, FIG. 4c.

 As shown in Figures 2, 3, 5 and 6, the tip 16 of the pocket holder is an integral part of a support piece 30, advantageously made by molding a plastic material such as high density polyethylene and whose base 15 on which is erected the endpiece 16 is pierced with lights 31a, 31b, etc. of arcuate shape, of progressively increasing dimension from light 31a to light 31l and which are distributed substantially along a center circumference O, through which the axis A passes. The light 311, whose outline is somewhat different from that of the other lights for reasons which will be explained below, is close to the light 31a and these two lights are provided in the vicinity of an ear 32 on which is provided an axis 33 for mounting a lever 41 for actuating the lock and which is further cut out according to a notch 34 which has a narrower portion 35 creating a "hard point "for the passage of a stud 49 of the lever which has just been mentioned.

According to the invention, the annular groove
E between the base 15 and the collar 18 is provided for receiving the appendages 25 of the pocket nose when the lock 40 is actuated (FIGS. 3 and 3a), advantageously molded from a plastic material such as polyamide or polypropylene, the molding of said lock, which is in the form of a radially split ring, being carried out under the "open" condition which is that shown in FIG. 3, so that said split ring tends to resume the shape shown in this figure when the actuating lever 41 which is associated with it tends to pivot in the opposite direction to arrow f in order to separate the free edges 42 and 43 of the ring from one another. The latter, which has a cross section in
U (FIG. 3a), that is to say at the bottom 44 and parallel wings 45 and 46 to limit a channel g, is connected to the lever 41 by a strand of material 47, said lever having a mounting eye 48 for articulation on the axis 33 of the support and the stud 49 adapted to cooperate with the notch 34. On the bottom 44 of the ring / latch 40 came from molding of the studs 501, 502, etc., in the same number as that lights 31 in which they are housed when the ring / latch is placed on the pocket holder against the base 15, the stud 50 forming a fixed anchor point for the split ring when the length of said ring is reduced , -by actuation of the lever 41 in the direction of the arrow f-, while the other studs 50 which move in the slots 31 are used for guiding.

 As a variant, the ring / latch is as shown at 40 'or 40 "in FIGS. 3b and 3c, that is to say with a cross section in L or in the form of a simple strip.

 For the implementation of a device according to the invention, the pocket holder 10 is first fixed to the patient's body using the pad 12 provided with an adhesive or an adhesive gum and the sheet 14 after, of course, the protective film 11 has been removed.

For the establishment of the pocket 21, this is presented opposite the pocket holder 10 and the pocket nose 20 is fitted onto the collar 18 practically without application of pressure in the area adjacent to the stoma due to the conical fitting of surfaces of conjugate shapes of the collar and of the pocket nose, fitting which simultaneously makes the tight connection from the pocket to the pocket holder. During this positioning, the appendages 25 of the pocket nose come opposite the annular groove E and when the cross section of the lock is as shown in FIG. 3a, the appendages penetrate effortlessly into the channel g whose dimension is then substantially that of the circle following which the appendages are placed: the condition is that shown in FIG. 5.

 Alternatively, when the cross section of the lock is as shown in Figures 3b or 3c, the appendages 25 are placed between the lock and the annular groove E.

 When, starting from this condition, the lever 41 is actuated by pivoting around the axis 33, in the direction of the arrow f, the length of the ring / latch 40 decreases and causes the appendages to be trapped and trapped 25 in the groove E to immobilize, therefore, the pocket nose on the pocket holder: the condition is then that shown in Figure 6 and the maintenance in this condition is obtained due to the cooperation of the stud 49 and the notch 34. The correct positioning of the lock on the appendages contributes to the fact that the light 311 guides the corresponding stud of the lock, to perfect the shape in closed condition of said lock, while the absence of preferential deformation of the appendages ensures secure fixing and perfect pocket nose on the pocket holder.

 To separate the pocket 21 from the pocket holder, it is a reverse process which is implemented after the lever 41 has first been unlocked and then maneuvered in the opposite direction to that described above.

Claims (11)

 1. Device for connecting a pocket and a pocket holder for an ostomy appliance comprising a pocket holder (10) intended to be fixed around an artificial opening of the body of a patient using '' a pad provided with an adhesive or an adhesive gum sensitive to pressure or by an equivalent means as well as a pocket (21) for collecting fluids and / or bodily waste suitable for being removably assembled to the holder pocket by a nose (20) which it presents, the pocket holder (21) comprising a collar (18) with frustoconical surface (19) and the pocket nose a conjugate frustoconical part suitable for cooperating with the collar, characterized in that the pocket nose (20) has appendages (25) directed parallel to its axis of symmetry and in that the pocket holder (10) comprises a latch (40) capable of blocking said appendages, -for fixing the pocket on the pocket holder, by trapping them in an annular groove (E) of the pocket holder.  2. Connection device according to claim 1, characterized in that the lock (40) is constituted by a split ring with which are associated means (41) for deforming it and varying its length in order to urge said appendages (25) and bring them into said groove (E) where they are blocked for fixing the pocket on the pocket holder.  3. Connection device according to claim 1 or 2, characterized in that the ring / latch (40) of variable length is associated with a support (30), which also carries the fixing pad (12) to the patient's body , the lock being positioned on the support (30) opposite the annular groove (E) formed between the collar (18) and a cylindrical part (17) of a nozzle (16) of which said collar forms an integral part and which is erected on said support (30).  4. Connection device according to any one of the preceding claims, characterized in that the latch (40) comprises a lever (41) hingedly mounted on an axis (33) integral with the support (30), said lever being of a part with the rest of the constituent ring of the lock to which it is connected by a strand of material (47).  5. Connection device according to claim 4, characterized in that studs (50) are associated with the lock (40), on the face of the latter in contact with the pocket holder, one of the studs (501) being intended to form a fixed anchor point of one end of the split ring (40) on the support and the others being able to move in slots (31) of the support (30) for guiding said latch when the latter is deformed -this by actuation of the lever (41).  6. A connection device according to claim 5, characterized in that that (31i) of the lights (31) of the support (30) in which are engaged the studs which is closest to the fixed end of the lock, but the part corresponding to the movable end thereof, is of particular shape for, when guiding the stud which is engaged therein, perfecting the shape in closed condition of said lock which is that of immobilization of the pocket nose on the pocket holder.  7. Connection device according to any one of the preceding claims, characterized in that the support (30) of the latch (40) has, in the vicinity of the axis of articulation of the operating lever (41), a notch ( 34) in which is adapted to penetrate a stud (49) of conjugate shape of the lock to block the latter in the closed condition by a "hard point" (35).  8. Connection device according to any one of the preceding claims, characterized in that the latch (40) produced as a split ring has a receiving channel (g) of the appendages (25) of the pocket nose, the length initial circumference of said channel (g) being substantially that of the pocket nose and its decrease causing the trapping of the appendages in the throat of the pocket holder.  9. Connection device according to any one of the preceding claims, characterized in that the appendages (25) which depend on the pocket nose (20) are shaped as sectors arranged in the circle limiting the opening that the nose has pocket, said sectors being preferably separated from each other by notches (27) with a V-shaped cross section.  10. Pocket for collecting fluids and / or bodily waste, in particular for enterostomy or urostomy suitable for entering into the constitution of a connection device according to any one of the preceding claims, characterized in that it comprises, around an opening of one of its walls, a pocket nose (20) directed towards the inside of the pocket whose surface suitable for cooperating with that of the collar (18) of the pocket holder (10) is a frustoconical surface and which is provided appendages (25) directed substantially parallel to the axis of symmetry of the nose for its attachment by a lock (40) of the pocket holder.  11. Pocket holder suitable for entering into the constitution of a device according to any one of claims 1 to 9 comprising a pad provided with an adhesive or an adhesive gum sensitive to pressure or an equivalent means of fixing to the body of a patient with a collar (18) providing a frustoconical surface (19) for the sealed assembly of a pocket (21) for collecting fluids and / or bodily waste, characterized in that under the collar ( 18) is formed an annular groove (E) for receiving appendages (25) depending on the pocket nose and where said appendages can be trapped by a lock (40) of modifiable length for fixing the pocket on the pocket holder .