FR2859906A1 - Connecting device for ostomy, has track and connecting part connected to fixing device and bag, respectively, and cradle and spline ensuring alignment of orifices in position found before removing protective film from adhesive surface - Google Patents

Abstract

The device has a track and a connecting part connected to a fixing device (10) and a bag, respectively. The track and part interact by adhesion in a plane perpendicular to axes of orifices of the device (10) and the bag to ensure transmission of bag`s weight and impermeability by adhesion. A cradle (18) and spline (20) ensure alignment of orifices in a position found before removing a protective film from an adhesive surface.

Description

2859906 1

  The invention relates to ostomy devices having a two-part construction.

  The two-part ostomy devices include a fixation device or support, which is glued to the skin around an ostomy, and a removable bag for connection to the fixation device. The advantage of these devices in two parts is that a single bonding of a fastening device around the stoma allows the successive use of several pockets, generally at least three. Indeed, although it is now possible to produce materials constituting moisture-absorbing and non-allergenic gums, the take-off operation always subjects the skin to constraints that it is desirable to space in time.

  Various connections have thus been made for sealingly fastening a collection bag to a fixing device. There are essentially two generic types of such fittings, a mechanical type and an adhesive type.

  Mechanical type couplings exist with many variants. Three of these are representative of this diversity.

  A first example of a mechanical connection is shown in FIG. 1. In this figure, it can be seen that a fixing device 10 having a rubber washer 12 bears a ring 14 having a plurality of lips delimiting a channel in which a cheek lodges. a ring 16 carried by a pocket. The mechanical strength is ensured by the cooperation of lips of the two rings 14, 16, sealing is provided by contact of a lip of the ring 16 with the body of the ring 14, and the guide for the positioning is ensured when the ring 16 is housed on the ring 14, the engagement being ensured simply by applying a force to the ring 16 to the ring 14.

  A second known mechanical coupling device is shown in FIG. 2. It should be noted that a fixing device and a pocket each comprise a ring 18, 20, the rings having lips designed to interlock with each other to ensure times mechanical strength and tightness.

  FIG. 3 represents another known mechanical connection in which a small pivoting lever 26 rotates a locking device which, once the two rings 22, 24 engage one another, locks them by clamping to ensure a very tight hold. robust.

  All these known mechanical devices have the advantage of allowing the two rings to cooperate only when they are well centered on one another, so that the positioning of the two coupling parts is excellent.

  However, they also have disadvantages. The seal is obtained by contact of one or more lips with a complementary surface. For a lip to give a good seal, it must have good elasticity, that is to say it must be either very thin, or formed of a relatively flexible material. If the material of the ring, and therefore of the lip, is flexible, the mechanical strength obtained is reduced. If the material of the ring is rigid and hard, the assembly of the connection constitutes a rigid element which creates a certain discomfort.

  In addition, all lip elements must meet tight tolerances; they are formed by injection and are therefore expensive.

  Given the cost of these mechanical connections and their disadvantages, attempts have been made to use connectors that work by bonding. Fittings were thus made in which an adhesive washer integral with the pocket, protected by a protective paper, is glued on a track of a device for fixing the patient. The advantages of such a connection by gluing are obvious: the assembly is flexible and not very thick, so it gives a good comfort, and as the bonding surface can be extended, the seal and the mechanical strength can be excellent.

  However, this adhesive bonding poses a problem: it is difficult to position an adhesive portion of the pocket on the fastener by aligning the orifices of these two elements.

  Because of the highly adhesive nature of the bag portion of the bag, as soon as it begins to adhere to an opposing part, it is no longer possible to move the two parts relative to each other. In addition, given the flexibility of the two coupling parts, which is a comfort advantage, the uniform application of the two parts on each other presents difficulties due to their flexibility.

  The object of the invention is the solution of this problem of mutual positioning of the two coupling parts in the case of gluing.

  More specifically, the invention relates to an ostomy device connector in which a guiding device ensures the alignment of the orifices of the fixing device and the bag before the beginning of the bonding of the two coupling parts.

  More specifically, the invention relates to an ostomy device connection, intended to connect a collection bag to a fixing device intended to be bonded to the skin of a patient, this connection having the functions of transmitting the weight of the pocket collecting the fixing device, positioning the pocket relative to the fixing device, so that an orifice of the fixing device is in communication with an orifice of the collection bag, and the seal between the collection bag and the fixing device, the coupling comprising a first integral connection part of the fastening device and a second connecting part integral with the collection bag, the two coupling parts being intended to cooperate with one another by gluing in a plane substantially perpendicular to the axes of the openings of the pocket and the fixing device, so that the transmission of the weight of the collection bag and the seal between the d fixing device and the collection bag are ensured by gluing. According to the invention, the coupling comprises a guiding device which ensures the alignment of the orifices of the fastening device and of the guiding bag in a substantially determined position before the co-operation by bonding the two parts of the fitting as they approach each other. one from the other.

  In a first embodiment, the connection comprises a hinge device defining a pivot axis remote from the orifices of the fixing device and the collection bag.

  In a first variant, the connector further comprises at least one auxiliary member for fixing the two connecting parts to one another.

  According to this variant, the at least one auxiliary fastener may be constituted by at least two snap-fasteners aligned on one axis, or the at least one auxiliary fastener may comprise two elements integral with the fastening device and the pocket, respectively. and which can provide mutual attachment by magnetic attraction, or the at least one auxiliary fastener may comprise a tab secured to a first part of the connector and a hoop secured to the other part of the connector, or the auxiliary fastening member at least may comprise a relatively rigid lug secured to a portion of the connector and intended to be housed in a housing integral with the other coupling part, or the at least one auxiliary fixing member may comprise shaped portions of hooks and loops integral with each of the coupling parts.

  In a second variant, the hinge device comprises a template defining a pivot axis. According to this variant, the template may be integral with a coupling part and intended to cooperate temporarily with the other coupling part, or the template may be intended to temporarily cooperate with the two coupling parts. It is then advantageous for the template to increase the rigidity of at least one of the first and second parts of the gland.

  In another embodiment, the guiding device comprises an auxiliary retaining device for the interlocking connection parts. According to variants of this embodiment, one of the interlocking parts comprises a temporary fixing device on the connecting part of which it is not integral, or one of the interlocking parts comprises several hook members distributed to the periphery of a coupling part, or at least one of the coupling parts comprises a magnetic device intended to cooperate in a defined position with a device complementary to the other coupling part.

  In all these embodiments, the bonding is preferably performed between an adhesive portion and a non-adhesive portion. It is then advantageous for the non-adhesive part to be integral with the connection part associated with the fixing device.

  In all these embodiments, the adhesive portion preferably carries a protective coating which has an extension defining a tab intended to be drawn substantially in the gluing plane.

  In all these embodiments, it is advantageous that the fixing device comprises a flexible rubber washer having a substantially central orifice intended to surround an ostomy, the washer being intended to be glued to the skin of a patient around a stoma, and a track attached to the washer tightly around the orifice.

  The invention also relates to a two-part ostomy device comprising a connector as defined above.

  Other features and advantages of the invention will be better understood on reading the following description of embodiments, with reference to the accompanying drawings in which: - Figures 1, 2 and 3 respectively show in section, in exploded section and exploded perspective view, three prior art mechanical type stoma connections, already described, FIGS. 4a and 4b respectively represent a fastening device and a pocket in which the guiding is provided by snaps; FIGS. 5a and 5b respectively represent a fixing device and a pocket in which a guide device is constituted by magnetic elements; - Figures 6a and 6b respectively show a fixing device and a pocket whose guide device is constituted by a male and female element fastener; - Figures 7a and 7b respectively show a fixing device and a pocket in which the guide is formed by fixing elements loops and hooks attached to the fixing device and the connecting portion of the pocket; FIGS. 8a and 8b respectively represent a fixing device and a pocket in which the guiding device is formed by fastening elements with loops and hooks fixed to the fastening device and to the body of the pouch itself; - Figures 9a and 9b respectively show a fixing device and a pocket whose guide is provided by a flat jig articulated about an axis; FIGS. 10a and 10b respectively represent a fastening device and a pocket similar to those of FIGS. 9a and 9b, but in which the jig is fixed permanently to the pocket; FIGS. 11a and 1b respectively represent a fastening device and a pocket whose positioning is ensured by two magnetized jigs respectively associated with the fastening device and the pocket; - Figures 12a and 12b respectively show a fixing device and a pocket in which the guide device is formed by interlocking washers secured to one of the fixing device and the other of the pocket; and - Figures 13a and 13b respectively show a fixing device and a pocket in another embodiment.

  Figures 4a and 4b show an ostomy device respectively comprising a fixation device 30 and a pocket 42, which can be sealingly connected by a connector according to one embodiment of the invention.

  The fixing device 30 comprises a washer 32 of rubber. In known manner, this gum contains a polymer and hydrocolloids, and it provides a robust attachment to the patient's skin around an ostomy.

  On the opposite side to the adhesive part of the eraser 32, a track 34 is fixed to the washer 32 around the orifice 36. This track constitutes a first coupling part. It is advantageously formed of polyethylene, copolymer of ethylene and vinyl acetate, or of a similar polymer which can be easily welded to the washer 32, around the orifice 36 and for only a part of the distance between the edge of the orifice and the periphery of the track which is free.

  The bag 42 has a body 44 and a connecting portion 46 which surrounds an orifice 48. A tab or lug 50 allows the holding part 46 to be held during take-off.

  According to the invention, an auxiliary fixing member is constituted by two snaps 38, 52, each having a part fixed to the fixing device 30 and another part fixed to the bag 42. In the embodiment shown, the parts females of the snaps 38 are attached to the edge of the track 34 and the male parts of the snaps 52 are attached to the edge of the fitting portion 46 which forms an adhesive surface. Thus, the snaps 38, 38 and 52, 52 define a pivot axis 40.

  During the setting-up, the fixation device having already been glued to the skin of the patient, the connecting part 46, which has an adhesive surface protected by a protective paper, is approached by its lower part of the snaps 38 in order to that the male parts 52 can be stapled on the female parts 38. The patient can easily put the snaps in cooperation since it can associate them with the blind, by 2859906 8 touch detection. From this moment, the upper part of the pocket 42 can be moved relative to the fixing device 30 only by pivoting about the axis 40.

  The patient then removes the protective paper from the adhesive patch portion 46 and, by pivoting upward about the axis 40, comes to apply the sticky surface against the track 34 of the fastener. Given the relative rigidity of the track 34 and the connecting part 46, the two parts stick together in a perfectly centered manner, that is to say that the orifice 36 of the fastening device is just in front of the orifice 48 of the pocket.

  Note that the bonding surface is very extensive since it covers the entire area between the central orifice 36, 48 and the circular periphery of the track 34 or the connecting portion 46. This bonding ensures in a known way a very good sealing and very good mechanical strength.

  These properties are obtained because the track 34 and the connecting portion 46 are perfectly centered. It is easy to see that if the two parts were off-center, the bonding surface, and therefore the mechanical strength, would be reduced, and the leakage probability at the bonded part would be reduced. Weak width would be high.

  FIGS. 5a and 5b show a similar device in which the role of the snaps 38, 52 is played by two small magnets, 54, 56, that is to say that they delimit a pivot axis in the direction of their length (40 in the figure). The result obtained is similar to that given by the device of FIGS. 4a and 4b. There is also the presence of a gripping ear 50 for easily separating the pocket from the fixing device when the bag is to be separated.

  In FIGS. 5a and 5b, as in the following figures, references identical to those of FIGS. 4a and 4b have been used to designate similar elements.

  Figures 6a and 6b show an embodiment in which the auxiliary fastening member is constituted by an elastic clip 58 intended to be housed in a guide 60 delimited by two lateral rails. When the pocket 42 is to be placed on the fixing device, the female part 60 intended to cooperate with the staple 58 is slid over it and thus clings elastically. Then, by rotation around the axis 40, after removal of the protective paper from the surface 46, this adhesive surface is applied to the track 34 of the fixing device. In this embodiment, there are shown gripping tabs 50 on the fastener.

  Of course, the staple can be replaced by many devices having similar functions, such as a clamp clinging to an axis, or a claw sliding in a channel. The essential characteristic is the determination of an axis for the rotation of the pocket relative to the fixing device.

  FIGS. 7a and 7b show an embodiment in which the positioning before gluing is provided not by rotation about an axis of articulation, but by aligning the two parts of the coupling in practice with one another before collage.

  More precisely, as indicated in FIGS. 7a and 7b, the fixing part has, either on the rubber washer 32, or at the edge of the track 34, two elements 62, 64, of fastening type of loops and hooks, known under the trade name "Velcro", which can be diametrically opposed as shown. The pocket comprises, at corresponding locations of the coupling part, two complementary fastening elements with loops and hooks 66, 68.

  In this case, since the fastening elements 62, 64 and 66, 68 are placed in cooperation when the adhesive surface of the connection portion of the pocket is not exposed and is always provided with its protective paper, it must be protective paper can be removed after the auxiliary fasteners have been put in cooperation. Consequently, the protective paper this time comprises two parts separated by a diameter 70. Each part has a half-circle portion 72 disposed on the half of the adhesive surface, in contact with the latter, and another part 74 which it is connected by simple folding and is longer so that it exceeds the outside of the pocket and can be seized. Accordingly, when the fasteners 62, 64 and 66, 68 have been attached, the two portions 74 of the protective paper protrude on the sides, and it is sufficient to pull them to disengage the adhesive surface which is then well positioned in front of the track 34 of the fixing device.

  FIGS. 8a and 8b show a variant in which the fastening elements of the loop and hook type 66 and 68, carried by the connection portion 46 of the pocket in FIG. 7b, are this time placed on the body 44 of the pocket , as indicated by references 76 and 78. The operation is the same.

  Figures 9a and 9b show another embodiment of the invention wherein the guide device is constituted by a template. The fixing device and the pocket are similar to those of Figure 1, but they do not include the snap fastener. On the contrary, the guide of the pocket towards the fixing device is provided by a template 80. It comprises two parts, a first part which ends with a notch in a semicircle 82 intended to surround the orifice 36 of the device. and a second which terminates in another notch 84 in a semicircle intended to surround the orifice 48, between the body 44 of the pocket and the connecting portion 46. The two parts of the jig 80 are hinged around a fold 86 which corresponds to the axis 40 of the embodiment of Figures 4a and 4b.

  The jig 80 may be free, or it may be attached either to the fastener or preferably to the pouch. Such a template is formed of a thin cardboard and does not constitute a real embarrassment if it is left during the wearing of the pocket.

  Figs. 10a and 10b show another embodiment in which a template 88 has been shown on the pouch. In this embodiment, the template portion that cooperates with the bag extends beyond the port 48 and ends with two arms 90. The template thus completely surrounds the port 48, and is therefore firmly held on the pocket. The arms surround a separation line 91 which allows the removal of the template once the pocket is placed on the fastener. The template can still be formed of a simple relatively thin cardboard.

  The embodiment of Figures 10a and 10b has an additional advantageous feature. Indeed, if the part 46 of the connector that carries the adhesive surface is very thin and flexible, the presence of the template increases the rigidity during installation, and it is easy to obtain a perfect bonding of the part 46 of connection on the track 34 of the fixing device.

  The embodiment of FIGS. 11a and 11b also comprises a fixing device and a pocket similar to those already described with reference to FIGS. 4a and 4b, but without the buttonpressure device.

  In this embodiment, a tab 92 has two magnetized portions 94 which surround a notch surrounding an angle exceeding a little 180, so that the notch can be retained between the washer 32 and the track 34 around the orifice 36. Similar tongue 96 having two magnetized portions 98 is slid between the adhesive connecting portion 46 and the pocket body 44.

  When the pocket is close to the fixing device, the magnetic fields of the magnetized portions 94 and 98, respectively, cause an alignment of the two tabs 92 and 96 so that they come to position the pocket with alignment of the orifices 36 and 48. After removing the protective paper, the tabs 92 and 96 can then be removed or not, or only one of them can be removed, for example that of the pocket.

  FIGS. 12a and 12b show another embodiment in which the fixing device, which still comprises the rubber washer 32 delimiting the orifice 36 and the track 34, also has a ring 100 of an elastic foam glued to the periphery of the track 34. The connecting portion 46 carries on its surface, around the orifice 48, a ring 102, for example formed of a rubber, whose outer diameter is very slightly less than or equal to the diameter internal of the foam ring 100 of the fastener. The pocket can thus be easily positioned relative to the fixing device by a housing of the ring 102 of rubber in the ring 100 of foam. In this embodiment, the adhesive surface of the coupling portion 46 is bonded to the foam ring 100 of the fastener.

  In this embodiment, the seal may be increased, for example by using an additional sealing surface formed between the track 34 and the rubber ring 102. The rubber of the ring 102 may be a type whose adhesive properties are increased in the presence of aqueous liquid, and thus gives a secondary sealing area which protects the main sealing area formed between the foam ring 100 and the adhesive fitting part 46.

  FIGS. 13a and 13b show another embodiment which, at first glance, appears to be analogous to the known adhesive fastening device which has no guiding device. There is thus the presence of the rubber washer 32 which carries the track 34 to which it is connected around the orifice 36. The pocket body 44 has a connecting portion 46 which is fixed thereto around the orifice 48. This embodiment differs from that of the prior art in that the track 34 and the connecting portion 46 are both formed of magnetized plastic material. More specifically, the track 34 is made of a plastic material loaded with a powder of rare earth compounds allowing permanent magnetization; the connecting part 46 is made of a similar material and carries on its surface an adhesive layer, protected by a protective paper. The magnetizations of the track 34, on the one hand, and the connecting part 46, on the other hand, are such that, when the two magnetized parts come closer together, they tend to align the orifices 36 and 48.

  Plastics loaded with rare earth element compounds or the like are well known in the art. It is not necessary to describe them. Several magnetization schemes are possible for the two opposing parts so that the centering or the alignment of the orifices 36 and 48 is carried out automatically. In this case, it is possible to separate the protective paper from the adhesive surface of the fitting portion 46 before bringing the bag closer to the fastener, the alignment being performed automatically when the fitting portion 46 approaches the track 34.

  The various embodiments described above concern various aspects in which the seal and the mechanical strength are essentially provided by the bonding.

  In some embodiments, the mechanical strength can be increased either by interlocking (for example, embodiment of FIGS. 12a, 12b) or by magnets (embodiment of FIGS. 13a and 13b).

  An essential property of the adhesive bonding devices according to the invention is the comfort given to the patients, since the fastening device such as the pocket can be very flexible and can adapt to the shape of the body. However, this flexibility can be a disadvantage for fixing. In this case, it is advantageous if a certain rigidity is introduced, preferably temporarily, either by means of a template, in particular in the embodiments of FIGS. 10a, 10b and 11a, 11b, or by incorporation of rings 100, 102 , which tend to keep a flat shape and thus facilitate the application of the pocket on the fixing device.

  Although embodiments have been described in which the track 34 of the fastener is not adhesive, and the connection portion 46 of the pocket is adhesive, the arrangement may be reversed. In addition, the bonding can be achieved with a two-component type adhesive one of which is placed on the track and the other on the connecting portion of the pocket.

  The embodiment of the protective element of the adhesive surface has not been described, as such an element is well known. In general, a paper coated with a layer of a silicone polymer placed in contact with the adhesive surface is used. Although there are shown in the embodiments of FIGS. 7a, 7b and 8a, 8b protective elements pulled by traction in opposite directions, it is also possible for the tongues to protrude in other directions, for example at mid-point. -distance between the horizontal axis and a fastening device with loops and hooks.

  The guide devices of the ostomy devices according to the invention can be used blind, without it being necessary to see the fixing device or the bag. Thus, the patient, when he has fixed the snaps or introduced the clip or fixed template, can confidently apply the adhesive part against the track without risk misalignment. The patient can then ensure good pinch bonding with the fingers of the track and the fitting part that are glued. If necessary, the patient can ensure proper positioning by touching the track and the connecting part whose peripheries correspond. The sealing surface, and thus the sealing, are then the best possible.

  Of course, many other embodiments may constitute a guide device according to the invention.

  For example, in the embodiment of Figs. 12a and 12b, although there is shown an outer ring of foam 100 on the fixation device and a rubber ring 102 on the pocket, it would be possible, in place of the Foam ring 100, using a thin ring-shaped projection surrounding the orifice 36 and being housed at the inner periphery of the ring 102 of gum pocket. In this case, the ring may be closer to the orifice 48.

  These devices are used for guiding and not for sealing. If they have a sealing effect, this is an auxiliary effect, the bulk of the seal being provided by the large surface adhesive contact between the fastener and the bag.

  Of course, various modifications may be made by those skilled in the art to the fittings and devices that have just been described by way of non-limiting example without departing from the scope of the invention.

2859906 16

Claims (10)

  An ostomy device connection for connecting a collection bag (42) to a fixation device (30) to be adhered to the skin of a patient, the connector having the functions of transmitting the weight of the collection bag (42) at the fastening device (30), positioning the bag (42) relative to the fastening device (30), so that an orifice (36) of the fastener is in communication with a port (48) of the collection bag, and the seal between the collection bag (42) and the fixing device (30), the connection comprising a first connecting part (34) integral with the fixing device and a second connecting part (46) integral with the collection bag, the two coupling parts (34, 46) being intended to cooperate with one another by gluing in a plane substantially perpendicular to the axes of the orifices (36, 48) of the pocket and the fastening device, so that the transmission of the weight of the pocket (42) and the sealing between the fixing device (30) and the collection bag (42) are provided by gluing, characterized in that it comprises a guiding device which ensures the alignment of the orifices (36). , 48) of the fastening device (30) and the collection bag (42) in a substantially determined position prior to the bonding engagement of the two parts of the coupling (34, 46) as they approach one another .   2. A coupling according to claim 1, characterized in that it comprises a hinge device defining a pivot axis (40) remote from the orifices of the fixing device (30) and the collection bag (42).   3. A coupling according to claim 2, characterized in that it further comprises at least one auxiliary member for fixing the two coupling parts to one another.   4. A coupling according to claim 3, characterized in that the auxiliary fastener at least is selected from at least two snaps (38, 52) aligned on an axis, two elements (54, 56) secured respectively the fastening device (30) and the pocket (42) and being able to provide mutual attachment by magnetic attraction, a tab secured to a first part of the connector and a hoop secured to the other part of the coupling, a relatively rigid tab (58), integral with a portion of the connector and adapted to be housed in a housing (60) integral with the other coupling part, and shaped portions (62, 64, 68, 70, 76, 78) of tissue with integral hooks and loops of each of the coupling parts (34, 46).   5. A coupling according to claim 2, characterized in that the hinge device comprises a template (80) defining a pivot axis.   6. A coupling according to claim 1, characterized in that the guiding device comprises an auxiliary retaining device (100, 102) of the interlocking connection parts.   7. A coupling according to claim 6, characterized in that one of the interlocking parts comprises a device (102) for temporary attachment to the connecting portion (46) which it is not integral.   8. A coupling according to claim 6, characterized in that at least one of the coupling parts (34, 46) comprises a magnetic device for cooperating in a defined position with a device complementary to the other coupling part.   9. A coupling according to any one of the preceding claims, characterized in that the fixing device comprises a flexible washer (32) having a substantially central orifice (36) for surrounding an ostomy, the washer (32) being intended to be adhered to the skin of a patient around an ostomy, and a track (34) sealingly attached to the washer (32) around the orifice (36).   10. A coupling according to claim 9, characterized in that the bonding between the washer and the track is provided by an adhesive provided with a protective coating, an extension forms a pull tab in the bonding plane.