HK1007098B - Stoma apparatus - Google Patents

Description

The present invention relates to ostomy devices and is intended in particular to be a device for joining a pocket holder and a stoma pocket.

Err1:Expecting ',' delimiter: line 1 column 520 (char 519)

Devices of the latter type must satisfy imperative conditions, some of which are contradictory: the fastening of the bag to the protective front plate or pocket holder must be possible without applying significant pressure to the area near the stoma, which is sensitive and usually painful, and must be possible with perfect tightness of the system assembly, while allowing easy but never untimely separation from the bag. In addition, the device must not cause peristaltic skin complications, must be as discreet as possible and must be able to wear pockets of very different morphologies. In addition, after the patient has learned to use the bag, the personnel must be able to carry out as simple and easy as possible the assembly of the pockets and the patient must be able to carry out certain manipulations, especially on the patient and the patient's own body, which are of course of course necessary for the assembly of the pockets and the use of the pockets themselves.

In order to try to solve this problem, a two-piece system has recently been proposed, for example in FR-A1-2 626 464, in which the means of attaching the pocket and the pocket holder consist of a deformable collar and a split ring arranged to tighten the collar, a tube with an outer dimension roughly equal to the inner dimension of the collar which can be inserted or removed by sliding into the collar when the ring is in an opening position, so that when the ring is in a tight position around the collar, the collar is deformed around the tube.The construction of the whole is relatively complex, since the diameters of the tube and the collar must be made with very low dimensional tolerances in order to achieve the tight assembly by a reduced deformation of the collar, which the U-section normally prevents from this deformation.Although the latter problem has already been considered, for example in EP-163 979, the solutions provided are not entirely satisfactory, either as regards the method of assembly or as regards the tightness and/or the size of the pocket-holding devices.

It is therefore a general purpose of the invention to provide such a device for digestive or urinary stomies which satisfies these conditions, in which the placement of the pouch on the pocket holder previously attached to a user's body is extremely easy, on the one hand, and is carried out, on the other hand, with virtually no pressure applied to the area adjacent to the stoma.

It is also an object of the invention to provide such an apparatus which is of high safety in use and in which, in particular, the bonding strength of the pocket to the pocket holder is strengthened when pressure is increased in the pocket.

The problem is solved in a two-piece stoma apparatus with a pocket holder designed to be attached to the user's body by means of a pad with an adhesive or pressure sensitive adhesive gum, or by an equivalent means, and a pocket for collecting fluids and/or body waste which can be assembled removably to the pocket holder by a nose which is characterized by the fact that, according to the invention, the attachment of the pocket to the pocket holder results from the deformation of a sealing medium whose radial dimension is increased by the action of a suitable actuator.

In such a device, therefore, and unlike the device known as FR-A1 2 626 464 or devices of the fitted type, no pressure is exerted in the vicinity of the stomae when the pocket is placed on the pocket holder, since the opening of the pocket nose is larger than that of the corresponding part of the pocket holder with which it cooperates and which surrounds the stomae in its condition of use.

Err1:Expecting ',' delimiter: line 1 column 234 (char 233)

In an early embodiment of the apparatus of the invention, the actuating device is a split ring and the sealing medium consisting of an elastic seal is attached to the ring between the pocket nose and the ring when the pocket is brought to the pocket holder.

Err1:Expecting ',' delimiter: line 1 column 267 (char 266)

Err1:Expecting ',' delimiter: line 1 column 264 (char 263)

In this mode of manufacture, too, the single component of the split ring and its means of operation is cast in its condition corresponding to the large size of the split ring.

In another embodiment, the actuating device consists of two half-rings to which is attached the elastic seal between the pocket nose and the half-rings when the pocket is brought back to the pocket holder.

Each half ring is preferably one piece with the means of operation consisting of a lever articulated on it and which controls a knee-operated mechanism.

Err1:Expecting ',' delimiter: line 1 column 132 (char 131)

Alternatively, the two half-rings are joined together by two knee-shaped mechanisms, each consisting of two arms articulated around a hinge and hinged on the half-rings, the levers being joined by a piece around two jointed hinge axes of the collar.

According to another feature of the invention, the seal is a straight-section trapezoidal seal and encloses a back of the split ring, the deformation of which during the operation of the actuator causes the seal to be sealed until the latter is applied to the pocket nose.

The latter is advantageously made of a plastic material rigid enough to absorb the clamping force developed by the seal with which it cooperates by its internal section with a general hyperbolic shape in the condition of assembly of the pocket and the pocket holder.

For the installation of the actuator on the pocket holder, the latter has a neck bounded by a collar, which surrounds the stoma in the condition of use of the apparatus, and by two collars substantially parallel and perpendicular to the axis of the collar, one collar cooperating in maintaining the seal and the other serving to consolidate the pocket holder and the roller, on the one hand, and to guide and/or hold the actuator on the said pocket holder, on the other.

To ensure this last function, the simplest provision is that the second collar be fitted with lights in which the nipples of the split ring are housed.

In another embodiment, the sealant is a split ring but conformed to save on its periphery protrusions suitable for cooperation with a groove or conjugate-shaped openings on the pocket nose.

In such a design the split ring is mounted on the pocket holder in a neck which has a point of the latter, the point having a truncated external face collarette with which the face of the pocket nose of the same conicity is suitable to cooperate and the means of operation is advantageously constituted by a lever which moves one of the ends of the split ring which has plots or analogues into which the holes of the lever are engaged to keep the latter, with locking, in the condition of assembly of the pocket on the pocket holder.

In another embodiment, the same elastically deformable organ acts as a seal, either by itself or by means of a ring directly connected to it, and as a actuating device.

In one embodiment of this embodiment, the organ used is a ring which can be deformed by means of a fluid, pneumatic or hydraulic, to increase its radial dimension when the pocket nose is sealed on the pocket holder.

In another design, the ring is an o-ring chamber which is inflatable and deflatable by means of an associated valve, the chamber itself forming a seal or alternatively containing an auxiliary seal.

The invention provides for a syringe-type device, or a reservoir of pressurized gaseous fluid, such as a portable compressed air pump, or a hydraulic device in which the movement of a lever allows a given volume of liquid to be transferred in and out of the inflation chamber.

Err1:Expecting ',' delimiter: line 1 column 178 (char 177)

In another embodiment of the apparatus of the invention, the radial dimension of a sealing medium comprising a seal-pad proper, mounted radially in relation to the pocket-holder sleeve and outwards from the sleeve, is increased by increasing the volume of a chamber adjacent to the sleeve.

In a first embodiment of this construction, the increase in volume of the chamber adjacent to the sealing boudoir results from the introduction into the chamber of an additional quantity of fluid compared to that originally contained.

This introduction may be achieved by mechanical means, such as local deformation by means of a lever or similar of a given volume capacity or, alternatively, by supplying to the chamber, directly or indirectly, a hydraulic or pneumatic fluid from a source of pressurized fluid, such as a syringe, pump, compressed gas tank, etc.

According to another feature of the invention, this capacity is limited by a wall of elastic material, on which a piston is capable of acting, the movement of which is controlled by the action of a lever or levers.

According to another feature of the invention, the capacity is enclosed in a solid case of the pocket holder by hinges and these have hooks with which are suitable to cooperate conjugated hooks of the piston actuating lever (s) to hold this or those lever (s) in their position corresponding to that of assembly of the pocket to the pocket holder.

In another embodiment, the capacity to supply the variable volume chamber adjacent to the sealing bucket can be connected to a pressurised fluid source by a valve device with a deformable flexible tube in between.

In one embodiment, the valve device is connected to a valve, which is itself connected to a blowpipe-type tube to inflate the capacity by a pump-like means.

In another embodiment of the invention, the sealing medium is a full or hollow element with lip or membrane fixing on a solid body of the pocket holder, which provides a means of changing the volume of the chamber adjacent to the sealing medium.

In one embodiment of this design, the body has channels leading into an enclosure whose volume can be changed and/or into which a pressurized fluid can be introduced.

Err1:Expecting ',' delimiter: line 1 column 184 (char 183)

Alternatively, the sealing medium is a full profile in a cellular material with a full surface skin, as obtained by the known techniques of application of foam or cellular type materials in the elastomer and/or plastomer industry.

In another variant, the sealant is a polygonal full or hollow straight-section ring in a low-hardness elastomer material, preferably 20 to 40 Shore A.

Err1:Expecting ',' delimiter: line 1 column 365 (char 364)

The invention also provides, in addition, for the jointing of a jointed tongue of one of the legs with the split ring, which is located in a sliding passage of the foot; the other leg is used to guide the other legs in relation to each other when they move closer and/or further away.

Regardless of the embodiment, the invention provides that the sealant is coupled to a support which can be rotated relative to the pocket sleeve, so that after the pocket has been brought back to the pocket sleeve it can be oriented relative to the pocket sleeve, as is sometimes desired to increase user comfort.

Alternatively, the sealing medium support is not rotated relative to the pocket sleeve and the pocket's orientation relative to the pocket can be achieved, while the pocket is mounted on the pocket, after a slight decrease in the radial dimension of the sealing medium which lowers the pressure applied by the pocket on the pocket.

In an advantageous design, the latter has a flask which holds the sealing medium against axial displacement, the inner diameter of the pocket nose being smaller than the outer diameter of the flask but larger than the outer diameter of the sealing medium.

The invention also concerns a pocket-holder suitable for incorporation into such a device.

The following description, made by way of example and by reference to the attached drawing, will be sufficient to understand the invention: Figure 1 is a perspective schematic view showing, at a distance from each other, a pocket and a pocket of a device according to the invention; Figure 2 is a partial longitudinal view of a pocket and a pocket of an apparatus according to the invention for a first embodiment; Figure 3 is a view similar to that of Figure 2 showing the pocket in relation to the pocket but before fixing; Figure 4 is a view similar to that of Figure 3 but after fixing the pocket on the pocket; Figure 5 is a partial view similar to that of Figure 3 but for another form of implementation; Figure 6 is a view similar to that of Figure 4 for the first embodiment; Figure 7 is a view similar to that of Figure 8 but for another form of implementation; Figure 6 is a view similar to the first embodiment; Figure 8 is a view for another form of implementation; Figure 8 is a view similar to Figure 6 but for another form of implementation; Figure 8 is a view similar to the first embodiment; Figure 8 is a view similar to Figure 8 but for another form of implementation; Figure 8 is a view similar to the first embodiment; Figure 8 is a view similar to the first embodiment; Figure 8 is a view similar to the second embodiment; Figure 8 is a view similar to the first embodiment; Figure 8 is a view similar to the second embodiment; Figure 8 is a view of the second embodiment; Figure 8 is a view of the first embodiment; Figure 8 is a view of the first embodiment; Figure 8 is a view of the first embodiment;in perspective, of this part; Figure 11 is an elevated view of a component part of an apparatus according to the invention for yet another embodiment and in a first condition; Figure 12 is a view similar to that of Figure 11 but for a different condition; Figure 13 is a partial view similar to that of Figure 11 but on a larger scale and for a variant; Figure 14 is a partial view similar to that of Figure 12 but for the variant shown in Figure 13; Figure 15 is a schematic view in cut according to lines 15-15 of Figure 14; Figure 16 is a schematic view,In the case of a device according to the invention, a pocket holder is raised for another embodiment; Figure 17 is a cut-out view according to line 17-17 of Figure 16, but on a larger scale; Figure 17A is a view similar to that of Figure 17, but for a different embodiment; Figure 17B shows the positioning of a pocket on a pocket holder; Figure 18 is a cut-out view according to line 18-18 of Figure 16; Figure 19 is a partial view similar to that of Figure 16, but for another embodiment; Figure 20 is a cut-out view according to line 20-20) of Figure 19; Figure 21 is a cut-out view similar to that of Figures 16 and 19 but for another embodiment; Figure 22 is a cut-out view according to line 21 of Figure 21; Figure 22-22 is a cut-out view similar to Figures 21 and 21; Figure 21 is a cut-out view similar to Figure 19but for another embodiment; Figure 24 is a cut-out view according to line 24-24 of Figure 23; Figure 25 is a cut-out view according to line 25-25 of Figure 23, but on a larger scale; Figure 26 is a section according to line 26-26 of Figure 23; Figure 27 is a schematic view similar to that of Figure 25, but for a variant embodiment; Figure 28 is a view similar to that of Figures 19 and 21, but for yet another embodiment; Figure 29 is a partial schematic cut-out view according to line 29-29 of Figure 28.But on a larger scale; Figure 30 is a view similar to Figure 28, but for a variant embodiment.

Err1:Expecting ',' delimiter: line 1 column 185 (char 184)The pocket holder 10, whose patch 12 has an opening 13 around the stoma in its condition of use, also includes, on the side of the patch 12 opposite to that coming into contact with the user's body, an adhesive composite sheet 14 which helps to protect the peristomal area and to keep it on the user's skin. On the side of the composite sheet 14 opposite to that of the patch 12 a collar 15 is attached to a tip 16 comprising a cylindrical sleeve or collar 17 of axis and another collar 18 which is approximately parallel to the collar 15.- and thus perpendicular as this last to the A-axis, the two collars 15, 18, sparing between them a 19th throat.

The latter is intended for the installation of a deformable ring, 20, e.g. a split ring comprising a substantially flat body 21 with a circular outline bounded internally by a back 22 with an inner surface 23 cylindrical and an outer surface 24 trunk, Figures 2 and 4.

On the back 22 of the deformable ring 20 is a ring or seal 30 of elastic material, preferably a thermoplastic elastomer (TEP), with a straight section of general trapezoidal shape and whose thickness, measured parallel to the A-axis, is approximately equal to the distance between collars 15 and 18 less the thickness of the body 21 of the ring so that the ring 30 also finds its place in the throat 19.To ensure the attachment of the pocket 40 to the pocket holder 10, it is then sufficient to deform the ring 20 to increase its dimensions and, consequently, those of the ring 30 until it is supported by force with a tightening effect against the internal surface 42 (in a straight section of general hyperbolic shape) of the nose of the pocket 41 directed inwards into the pocket 40 and made of a relatively rigid material, for example high density polyethylene or polypropylene.

To achieve this and bring the apparatus into the condition shown in Figure 4, the invention provides for the combination of the deformable ring 20 with a suitable actuator. In the embodiment described and represented, the actuator 50 is made as a lever to move the adjacent ends of the split ring apart and lock the apparatus in this operating position, most simply by making plots or analogues of the ring periphery cooperate with hollows on the inner edge of the lever.

A counter-operation of the lever 50 in the opposite direction, i.e. the return of the split ring 20 to its original condition, this small size allows the pocket 40 to be removed from the pocket holder 10.

The bag 40 for collecting body fluids and/or body waste suitable for discharge through the nozzle 16 may be of a disposable or emptying type and is made by bonding, welding or similar, an external collar 43 from the nozzle of the bag 41 to the bag itself consisting of a polyethylene or PVC film or polyamide, or a complex barrier film of the type polyethylene/EVA/vinyl polychloride/EVA/polyethylene, such as those known under the registered trade mark SARYOANEX of the DOW CHEMICAL Company or a complex film of the type EVA/copolymer polyethylene-EVOL, known under the trade mark CRVA or the company's type GRAVA/EVA/EVA, or a similar film.

The operation of the apparatus is simple and safe and very satisfactory operation has been obtained for a construction comprising a 16 point of about 55 mm diameter, a pocket nose of about 68 mm internal diameter and a seal ring or seal of about 66 mm external diameter.

Figures 5 and 6 illustrate another embodiment: the 40′ pocket is welded or glued to a 41′ pocket nose, which is directed inwards and conformed to a 42′ trunked inner surface, the large base of which is cut into grooves or grooves.is designed to cooperate with the 41′ pocket nose by means of a rib 47 with a 48 trunk surface and the same conicity as the 42′ pocket nose. In this design, the 20′ expansion deformable organ is also a plastic split ring, advantageously moulded from one piece with a 50′ actuator to increase its dimensions from the condition shown in Figure 5 to the condition shown in Figure 6, which is the condition of attachment of the 40′ pocket to the pocket holder.

In order to implement such a device, the pocket holder is first attached to the user's body by means of the patin 12 fitted with an adhesive or adhesive rubber and sheet 14 after the protective film has been removed, of course.

To separate the 40′ pocket from the pocket holder, a reverse process is carried out after the 50′ lever has first been unlocked and then moved in the opposite direction to that described above.

The invention is by no means limited to the methods of manufacture and application just described. Thus, as shown in Figure 7, it provides for those forms of manufacture in which the fastening of the pocket to the pocket holder results from the deformation of an organ whose dimensions are increased by means of a pneumatic or hydraulic fluid. In the method of manufacture shown, the pocket 60 has a pocket nose 61 directed inwards into the pocket and whose inner surface 62 is curved, e.g. a hyperbolic contour.straight trapezoidal section, of elastic material, e.g. thermoplastic elastomer (TEP), connected by a stud 65 to an o-ring 66 housed in the neck 70 formed on a jointed tip 71 of the pocket holder between a cylindrical neck of axis A and two external and internal collars 67 and 68, respectively, substantially parallel to each other and perpendicular to the axis A. The elastically deformable and advantageously in the same material as the ring 64 chamber 66 is connected to a tip 72 pierced by a channel 73 through which a valve is placed, not shown.

The operation of this form of construction follows immediately from the above. The pocket holder being fixed to the user's body and the chamber 66 deflated, the pocket 60 is presented in front of the pocket holder and the pocket nose 61 is easily placed on the ring 64. At the end 72 of the pocket holder, a 66′ means of inflation, hydraulic or pneumatic, such as a syringe device, a reservoir of pressurized gas fluid such as a portable compressed air pump or a device in which the movement of a transverse channel allows a liquid chamber to be fixed to the given volume of 73 under the door 66 which then increases in volume and pressure, the pocket 61 then applies pressure against the pocket 61 of the pocket holder to secure the pocket 60 under the door.

This is an inverse process which is used to separate the pocket from the pocket holder after the hydraulic or pneumatic fluid pressure in chamber 66 has been removed.

Err1:Expecting ',' delimiter: line 1 column 778 (char 777)84, the two branches 85 and 86 of which are articulated around a hinge 87 on the one hand and are also articulated around a hinge 88 on the half-ring 80a and around a hinge 89 on the half-ring 80b on the other hand, the hinge 88 also forming the pivot axis of the lever 83.- as is also the 85-arm, whereas in the small size condition shown in Figure 8 the lever 83 is the 85-arm and 86 protrudes in relation to this ring.

To facilitate the operation of the lever 83 and to increase the manoeuvrability of the device, the lever and the joint areas 88 and 89 are moulded with over-thicknesses in relation to body 21, to the back 22 and to the sail forming arms 85 and 86, which are further curved to correspond to cutouts 90 and 91 of the half-rings 80a and 80b to provide accommodation for the arms, Figures 9 and 10.

The operation of this form of implementation is similar to that described in Figures 1 to 4. The pocket holder being fixed to the user's body by the patch 12, the lever 83 is brought into the condition shown in Figure 8: in this condition, the pocket 40 can be presented facing the pocket holder and the pocket nose 41 brought effortlessly and without difficulty onto the ring 24. When the lever 83 is then rotated in the direction of the f-arrow around the joint at hinge 88, Figure 8, the joint 87 is moved in the direction of the p-arrow, which diverges the other two ends of the half-annealed 80a and 80b rings of the slot 81. A condition is shown in Figure 83, where the adjacent position of the pivot is to ensure that the nose is fixed on the end of the pocket of the port 9 to ensure contact with the end of the pocket.

To separate the pocket from the pocket holder, the lever 83 is brought by an inverse pivot from the one just described from the condition shown in Figure 9 to that shown in Figure 8, which restores the split ring 80 to its small size and the elastic ring 24 to its initial condition, thus allowing the pocket nose 41 to be removed by spacing the pocket holder.

Figures 11 and 12 illustrate another embodiment, similar to that in Figures 8 to 10, with, however, a split of the means of deformation ensuring a more flexible operation, but identical in principle to that of the embodiment in Figures 8 to 10. In this embodiment, the actuating device is a ring 100 split into two diametrically opposite zones 81 and 82 to create two half-rings 100a and 100b joined by two knee-mounted mechanisms each made up of two arms, each named 95, 96 for the first and 95' and 96' for the second,As can be seen in Figures 11 and 12, the arms 95 and 96 are articulated around a hinge 97 and the arms 95' and 96' are articulated around a hinge 97', the articulation on each of the half-rings 100a and 100b being made by means of hinges 99 and 99', respectively.In this embodiment, the two levers 103 and 103' in the direction of the g and g' arrows are actuated to increase the size of the ring 100, Figure 12, and consequently to fix a pocket on the pocket holder, by rotating the levers in the opposite direction, which, on the other hand, allows the pocket to be released from the pocket holder.

In the variant shown schematically in Figures 13 to 15, the 95a and 95a arms (analogous to the 95 and 95' arms of the previous design) are each configured to accommodate a 105, 105a horn, respectively, less thick than the arm it extends (Figure 15) and which, as a result, overlaps the peripheral margin 44 of collar 43 of the pocket nose 41 (Figure 14) when the pocket is attached to the pocket holder.

Figures 16 to 18 refer to another embodiment: in this embodiment the fastening of the pocket 120 to the pocket holder 110 - with adhesive patin 112 protected by a film 111 - is achieved by increasing the radial dimension of a sealing medium 122 comprising a sealing bucket proper, 123, with a somewhat trapezoidal right section which is joined by two flexible, elastic lips or membranes, 124 and 125, fixed on two walls 126 and 127 distant from each other of the pocket holder, and delimiting between them a chamber 128, adjacent to the bucket 123.Err1:Expecting ',' delimiter: line 1 column 281 (char 280)In the embodiment described and shown, the capacity 146 is secured by a casing 147 enclosed in a case 148 fixed by its peripheral edges 149 and 150 (which are also enclosed by a rolled edge with the free ends of the case 147) on parts of the body 159 of conjoined shapes 151 and 152. On the latter two posts 153 and 154 are erected symmetrical to a diameter plane p of the device and which support the case 148 laterally by a set of ribs of substantially triangular straight sections 148a and 148b of the said case.Figure 18 shows in the throats of the hinges, in the form of conjugate shapes, the hooks 155 and 156 of the hinges opposing a radial movement outwards from the housing, the hooks 157 and 158 being complementary on the outside.

In case 148 a piston 160 is fitted in a sliding position, capable of being moved radially in response to the action of a lever or levers at cams 161 and 162. These levers, whose operating surfaces are shown in 167 and 168, are fitted with arms 163 and 164, respectively, and are pivotally fitted in case 148 around axes 165 and 166.

For the installation of such a device, the pocket holder 110 is first attached to the user's body by means of the patin 112. For the installation of a pocket 120 it is placed in front of the pocket holder 110 and the pocket nose 121 is placed around the seal bolt 123, without applying pressure to the area adjacent to the ostomy, i.e. without pain to the user. The levers 161 and 162 are then rotated around the axes 165 and 166, as shown by the arrows i and j in Figure 16 to move the piston 160 in the direction of the pocket holder's A-axis,This movement of the piston deforms the envelope 147 and the fluid (gas or liquid) contained in the capacity 146 is carried by the channels 145 to chamber 128, the volume of which increases by causing the radial displacement of the sealing knob 123 at the distance of the sleeve 115, when the latter is in contact with the pocket nose 121 (made of relatively rigid material) and leans on it, the desired sealing fixation of the pocket 120 on the pocket holder 110 is achieved, the maintenance of the device in working condition being achieved by the fact that the arms 163 and 161 of the hoists 153 and 162 at their ends are connected by hooks and hooks of the hooks 15 and 157 of the hoists 158 and 154.To separate the pocket 120 from the pocket holder 110, the reverse process is carried out after the levers 161 and 162 have been unlocked and then moved in the opposite direction to that described above.

In the variant shown in Figures 17A and 17B, the inner diameter Φ1 of the pocket nozzle 121 is smaller than the outer diameter Φ2 of the flask 140 but larger than the outer diameter Φ3 of the nozzle 123, the height of the nozzle 121 (as measured parallel to its axis of symmetry) being less than the thickness of the nozzle 123. In order to position the pocket, and taking advantage of the deformability of the nozzle 121 made of thermoplastic material, it is inserted into the space around the inner face of the flask 140 and the return nozzle 136, 17B, in a manner similar to which the nozzle 121 is placed on a pneumatically sealed wheel, but without any other difficulties.

The structure of the apparatus shown in Figures 19 and 20 is very close to that described above and the corresponding parts bear the same references.

In the figure 21 and 22 (where the parts corresponding to the figures 16 to 18 have the same references as in these figures), the piston 160b is not mounted in radial displacement but in a direction parallel to the axis of the sleeve 115 when a lever 172 is actuated which causes the piston 160b to penetrate more or less deeply into the 148′ housing.

In the figure 23 to 26, where again the parts identical to those in Figures 16 to 18 have the same references as in the latter, the channels 145 connect chamber 128 to a chamber or capacity 175 closed by a plug 176. At chamber 175 a flexible, deformable tube 177, on which a valve 178 is placed, itself connected to a nozzle 179, of the conical or Luer type, is fitted for connection to a source of fluid under pressure.In a second position of the tip, valve 178 allows the fluid to be introduced into chamber 175 to control the radial movement of the seal bolt 123 against the pocket nose 121, which, as in the previous embodiments, is rigid enough to accommodate the pressure thus applied. To facilitate the use of the apparatus, the invention provides that the flexible tube 177, like a tuned tube, may be held near the pocket holder on which it is positioned by a flange 181 (when the pocket is attached to the pocket holder) while the tube 177 may be removed from it to facilitate the connection of the tip 179 to the fluid source under pressure.

In the design shown very schematically in Figure 27, which is otherwise identical to that described immediately above in reference to Figures 23 to 26, between valve 178' and chamber 175 into which the channels 145 exit, a pressure-control valve 185 and a blowpipe, 186 are interposed, the whole valve 185 and the tube 186 constituting an inflation pump system of chamber 128 through chamber 175 and channels 145. In this design, the radial dimension of the seal nozzle 123 is increased by removing, for example by screwing, a push button on valve 178' and then by deforming the air-stop nozzle 186 longitudinally like a pump, the pressure in the nozzle, and thus applying pressure to the valve 177, while maintaining the pressure on the nozzle, while the nozzle is simply pulled out of the nozzle, after the pressure has been removed from the nozzle 176, and the pressure is released from the valve 176, the pressure is reduced to 120°C, and the valve is therefore kept free of the pressure, while the nozzle is moved from the nozzle to the valve 176, and the pressure is maintained at the point of the nozzle, thus increasing the pressure of the nozzle to 110°C.

Err1:Expecting ',' delimiter: line 1 column 217 (char 216)This wall is joined by a base 191 substantially perpendicular to the A-axis of the device and has an outer face 192, inclined in the direction of this axis. On the base 191, concentrically to the wall 190 and adjacent to it, a right-section triangular washer 193 houses with the back 140 of the sleeve 115 a reception housing for the waterproofing pudding 123.a foam or alveolar material with integrated skin is particularly suitable.

Err1:Expecting ',' delimiter: line 1 column 117 (char 116)

Err1:Expecting ',' delimiter: line 1 column 350 (char 349)

Err1:Expecting ',' delimiter: line 1 column 390 (char 389)

Err1:Expecting ',' delimiter: line 1 column 202 (char 201)

In the embodiment shown schematically in Figure 30 a 202′ tooth (analogous to 202′ tooth in Figure 28 and 29) is associated with leg 201, this tooth being suitable for cooperation with a 198′ ergot (analogous to 198′ ergot) provided on leg 200. In this embodiment, whose operation is similar to that described above in reference to Figures 28 and 29, the tongue 197, at end 203 at the point of a harpoon, slides into passage 199 when legs 200 and 201 are brought together which the user can squeeze between his fingers until cooperation of the 202′ tooth and 198′ ergot, while the de-solidisation of the 202′ tooth in relation to the 198′ conditioner, most simply by lifting the end of the tongue, which brings the elastic effect shown in Figure 195 back to 204′.

The fact that the manoeuvring device 195 can rotate freely about the A-axis of the device in its condition shown in Figures 28 or 30 gives the user the advantage of positioning the legs 200 and 201 in the best possible way for his comfort and/or handling.

Claims (30)

1. Stoma equipment comprising a bag-carrier (10, 110) for fixing around an artificial opening in the body of a user by means of a base plate provided with an adhesive or with a pressure-sensitive adhesive rubber or with any equivalent means, together with a bag for collecting body wastes and/or fluids and suitable for being removably assembled to a sleeve or collar of the bag carrier by means of a rim on the bag, the equipment being characterized in that the bag (40, 40', 60, 120) is fixed on the bag-carrier (10, 110) by deforming sealing means (30 20', 64, 122) whose radial size is increased by operating an appropriate actuator device (20, 20', 66, 80, 100, 128, 195).
2. Equipment according to claim 1, characterized in that the actuator device is a split ring (20, 80) which is associated with the sealing means constituted by a sealing ring (30) of resilient material interposed between the bag rim (41) and the split ring when the bag is applied to the bag-carrier (10).
3. Equipment according to claim 2, characterized in that the split ring (80) is integrally formed with actuator means (83) constituted by a lever hinged on the split ring and controlling a toggle type mechanism (85, 86).
4. Equipment according to claim 1, characterized in that the actuator device is constituted by two half-rings which are associated with the sealing means (30) made of resilient material interposed between the bag rim (41) and the half-rings when the bag is placed on the bag-carrier.
5. Equipment according to claim 4, characterized in that each half-ring is integral with actuator means constituted by a lever hinged thereto and controlling a toggle mechanism.
6. Equipment according to claim 4, characterized in that the two half-rings (80a, 80b) are connected to each other by a toggle mechanism itself constituted by two arms (85, 86) which are hinged to each other about a hinge (87) and which are hinged to respective ones of the half-rings (80a, 80b) by hinges (88, 89), the first of which also constitutes the fulcrum of a lever (83).
7. Equipment according to claim 4, characterized in that the two half-rings (100a, 100b) are interconnected by two toggle mechanisms, each constituted by a pair of arms (95, 96, 95', 96') hinged together about a hinge (97, 97') and hinged to the half-rings (100a, 100b) via respective hinges (99, 99'), fulcrums for levers (103, 103') being formed about two hinge axes (98, 98') fixed to the flange (15) by a part (104).
8. Apparatus according to claim 2, characterized in that the sealing ring (30) has a trapezium-shaped right cross-section and is engaged around a lip (22) on the split ring, deformation of the split ring during operation of the actuator means (50, 83) deforming the sealing ring (30) until it is applied in leakproof manner against the bag rim (41).
9. Equipment according to any preceding claim, characterized in that the bag rim (41, 61) is made of a plastic material that is rigid enough to accept the clamping force developed by the sealing ring (30, 64) with which its inside face (42, 62) of generally hyperbolic section co-operates when the bag (40, 60) is assembled to the bag-carrier.
10. Equipment according to any preceding claim, characterized in that to mount the actuator device (20, 20', 66, 80) on the bag-carrier, the bag-carrier has a groove (19, 19', 70) delimited by a collar (17, 71) which surrounds the stoma when the equipment is in use, and by two flanges (15, 18; 15', 47; 68, 67) which are substantially parallel to each other and perpendicular to the axis (A) of the collar, a first one of the flanges (18, 67) cooperating in retaining the sealing ring (30, 64) and a second one of the flanges (15, 15', 68) serving firstly to fix the bag-carrier to the base plate (12) and secondly to guide and/or retain the actuator device on said bag carrier.
11. Equipment according to claim 10, characterized in that the flange (15, 15') for guiding and/or retaining the actuator device is provided with slots (26) which receive studs (25) on the actuator device.
12. Equipment according to claim 1, characterized in that the sealing means is a split ring (20') shaped to have projections (46) at its periphery suitable for co-operating with hollows or a groove (45) of complementary shape provided in the bag rim (41').
13. Equipment according to claim 1, characterized in that the same elastically deformable member (66) acts both as the sealing ring and as the actuator device.
14. Equipment according to claim 13, characterized in that the elastically deformable member is an inflatable and deflatable toroidal chamber, and in that the inflation means (66') for inflating the toroidal chamber (66) is a syringe type device, a supply of gaseous fluid under pressure such as a portable compressed air cylinder, or a hydraulic device in which the displacement of a lever serves to transfer a given volume of liquid into or out from said chamber (66).
15. Apparatus according to claim 1, characterized in that the sealing means (122) whose radial size is increased comprises a sealing ring per se (123) mounted to move radially relative to the sleeve (115) of the bag-carrier (110) and away from said sleeve (115) when the volume of a chamber (128) adjacent to said sealing ring (123) is increased.
16. Equipment according to claim 15, characterized in that the volume of the chamber (128) adjacent to the sealing ring (123) is increased by inserting a quantity of fluid into said chamber (128) in addition to the fluid that it contained initially, said insertion being obtained by mechanical means such as locally deforming a space of given volume (146) by means of a lever or the like (161, 162, ..., 170, 172), or in a variant by directly or indirectly conveying a hydraulic or a pneumatic fluid into said chamber (128) from a source of fluid under pressure such as a syringe, a pump, a supply of compressed gas, etc. ... (Figures 23 to 26, and Figure 27).
17. Equipment according to claim 15, characterized in that the sealing means (122) is a solid or hollow component having lips or membranes (124, 125) for fixing to a body (129) integral with the bag-carrier (110) and including means enabling the volume of the chamber (128) adjacent to said sealing ring (123) to be modified.
18. Equipment according to claim 17, characterized in that the body (129) has channels (145) opening out into an enclosure (146, 175) whose volume can be modified and/or into which a fluid under pressure can be inserted.
19. Equipment according to claim 16, characterized in that the space (146) is delimited by a wall (147) of resilient material against which a piston (160, 160a, 160b) is disposed to act, displacement of the piston being controlled by actuating one or more levers (161, 162; 170, 172).
20. Equipment according to claim 19, characterized in that the space (146) is enclosed in a box (148) fixed to the bag-carrier (110) by brackets (153, 154), and in that said brackets have hooks (157, 158) suitable for co-operating with complementary hooks on the piston actuating lever(s) (160, 160a, 160b) to hold said lever(s) in a position corresponding to the bag (120) being assembled to the bag-carrier (110).
21. Equipment according to any one of claims 15 to 18, characterized in that the space (175) for feeding the variable volume chamber (128) adjacent to the sealing ring (123) via the channels (145) may be connected to a source of fluid under pressure by a valve device (178, 178') via a flexible deformable tube (177, 186).
22. Equipment according to claim 21, characterized in that the valve device is connected to a non-return valve (185) itself connected to a bellows type tube (186) for inflating the space (175) by means analogous to a pump (Figure 27).
23. Equipment according to claim 15, characterized in that the means for increasing the radial size of the sealing means (122) comprise a split ring (195) and a washer (193) adjacent to said sealing means (122), the split ring (195) and the washer (193) interacting by a wedge effect to deform said sealing means (122) radially.
24. Equipment according to claim 23, characterized in that the split ring (195) has actuator lugs (200, 201) at its ends for moving said ends towards each other and latches, hooks, catches, or the like (196, 198, 202; 198', 202', 203) for holding it in an open position or in a closed position.
25. Equipment according to claim 24, characterized in that the split ring (195) also includes a tongue (197) fixed to one of the lugs (201) and slidably received in a passage (199) through the other lug (200) to guide said lugs relative to each other while they move towards each other and/or while they move away from each other.
26. Equipment according to any preceding claim, characterized in that the sealing means and the body carrying the sealing means are mounted to rotate relative to the sleeve of the bag carrier.
27. Equipment according to any preceding claim, characterized in that the sealing means (30, 122) is made of an elastomer type material and/or of a cellular or foam type plastomer having an integral skin.
28. Equipment according to claim 27, characterized in that the sealing member (122) is a solid or a hollow body made of an elastomer material having hardness lying in the range 20 to 40 on the Shore A scale.
29. Equipment according to any one of claims 15 to 28, characterized in that the sealing means (122) is held on the bag-carrier (110) against axial displacement by means of flange (140), and in that the inside diameter (⌀1) of the bag rim (121) is smaller than the outside diameter (⌀2) of said flange but larger than the outside diameter (⌀3) of the sealing means (122).
30. A bag-carrier suitable for constituting part of equipment according to any one of claims 1 to 29 and comprising a base plate (11, 111) provided with an adhesive or with a pressure-sensitive adhesive rubber or with equivalent means for fixing to the body of a user, the bag-carrier having a sleeve (17, 115) for insertion inside the bag rim (41, 121) in the assembled condition of the equipment, the bag-carrier being characterized in that it includes sealing means (30, 122) around the sleeve (17, 115) and a device for increasing the radial size of said sealing means (30, 122) in order to fix the bag to the bag-carrier.