Note: Descriptions are shown in the official language in which they were submitted.
1- 2~36~
The present invention relates to stoma equipment and more
particularly it relates to a system for assembling a stoma bag
to a bag-carrier.
Numerous types of equipment have already been proposed for
collecting body wastes or urine fm m peopls who have been
subjected to surgical operations such as enterostomy
(ileostomy, colostomy, ...) or urostomy. This prior equip~ent
includes systems constituted by single-use bags which are
generally fixed directly to the skin of ths user by an adhesive
- in the form of a ring or which are provided with a skin
protector, and "two-part" systems in which the collection bag
(which may be disposable or reusable) is removably couplsd to a
protective front plate itself fixed to the b~dy of the user by
means of a belt or a base plate provided with an adhesive or
with adhesive rubber.
Systems of the second-mentioned type must satisfy certain
necessary conditions, some of which are mutually contradictory.
The collector bag should be fixed onto the bag-carrier or
protective front plate in such a manner that no significant
pressure is applied to the region around the stoma which is
sensitive and generally painful, while nevertheless ensuring a
reliably leakproof connection when the system is assembled, but
still allowing the parts of the system to be disassembled
easily, although never accidentally. In addition, the
equipment should not give rise to peristomal skin
complications, it should be as unobtrusive as possible, and it
should be capable to being fitted to patients of very different
morphologies. It is also desirable that, after receiving
instruction from medical personnel, patients should themselves
be capable of installing collection bags on their bag-carriers,
and this naturally requires the operations of assembling and
disassembling the bag and the bag~carrier to be as simple and
as easy as possible, particularly for elderly users.
Thus, in an attempt to provide a solution to the problem
posed, proposals have recently been made ~in FR-Al-2 626 464,
2 ~ Ll 3 Ç; '~ 6
for example) to provide a two-part system in which the means
for coupling the bag to the bag-carriex are constituted by a
deformable collar and a split ring designed to clamp around the
collar, and a short tube whose outside dimension is
substantially equal to the inside dimension of the collar which
is suitable for being slidably inserted into the ooll OE or
withdrawn therefrom when the ring is in an open position, such
that when the ring is in a clamped position ar~und the collar,
~he collar is deformed against the tube. It is relatively
difficult to malnufacture this system given that the diameters
of the tube and of the collar must be made to very accurate
- tolerances so that a leakproof assembly is obtained by
relatively little deformation of the collar, whose channel
section normally hinders such deformation. Similar
J difficulties exist in very numerous proposed systems of the
interfittlng type, e.g. as described in EP-A-0 171 255, or the
tvpe described above, and it will be understood that in spite
of the variety of solutions that are already known, the problem
remains of providing improved stoma equipment capable of
satisfying the various requirements for such equipment and also
making it possible to place the bag in a desired direction
relative to the bag-carrier, as may be desirable for increasing
user comfort. Although this bag direction problem has already
been considered, e.g. in EP-163 979, the solutions proposed are
not entirely satisfactory, neither with respect to the way the
parts are assembled nor with respect to leakproofing and/or the
size of the devices for connecting the bag to its support.
Consequently a general ob;ect of the invention is to
provide such equipment which is applicable to digestive or
urinary stomata while satisfying the above conditions, and in
which it is firstly extremely easy to install a bag on a bag-
carrier previously fixed to the body of a user, and secondly in
which this can be done while applying practically no pressure
to the region adjacent to the stoma.
Another object of the invention is to provide such
equipment which is very safe in use and, in particular, in
which the leakproofing of the connection between the bag and
3 ~3~
the bag-carrier is reinforced whenever the pressure inside the
bag increases.
The problem is solved in a two-part type stoma equipment
comprising a bag-carrier for fixing to 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 the bag-
iO carrier by means of a rim on the bag, wherein, aocording to theinvention, the bag is fixed on the bag-carrier by deforming
-~ sealing means whose radial size is increased by operating an
appropriate actuator device.
Consequently, in such equipment and in contrast to the
:- ~rior system described in FR-Al 2 626 464 or to systems of the
interfitting type, no pressure is exerted in the vicinity of
the stoma while the bag is being installed on the bag-carrier,
given that the rim of the bag is larger in size than the
corresponding part of the bag-carrier with which is co-operates
and which surrounds the stoma when in use.
In addition, in the equipment of the invention, the rim of
the bag is inside the bag proper, thereby avoiding a "stlcking"
effect between the bag-carrier and the sheet constituting the
bag, which "sticking" sometimes prevents body waste being
'5 evacuated satisfactorily.
In a first embodiment of apparatus of the invention, the
actuator device is a split ring which is associated with the
sealing means constituted by a sealing ring of resilient
material interposed between the bag rim and the split ring when
the bag is applied to the bag-carrier.
In one form of this first embodiment, the split ring is
integrally formed with actuator means constituted by a lever
hinged on the split ring and controlling a toggle type
mechanism.
The split ring and the actuator means are preferably
molded in a plastiOE material having mechanical and resilient
properties enabling them to constltute the fulcrums of the
lever and of the toggle mechanism by a hinge effect.
i
2 ~
In this particular form, the single part constituting the
split ring and its actuator means is molded in its
configuration corresponding to the large size of the split
ring.
In another embodiment, the actuator devi oe is constituted
by two half-rings which are associated with the sealing means
made of resilient material interposed between the bag rim and
the half-rings when the bag is placed on the bag-carrier.
Preferably, each half-ring is integral with actuator means
constituted by a lever hinged thereto and controlling a toggle
mechanism.
In another embodiment, the two half-rings are connected to
each other by a toggle mechanism, itself constituted by two
arms which are hinged to each other about a hinge and which are
:- hinged to respective ones of the half-rings by hinges, the
first of which also constitutes the fulcrum of a lever.
In a variant, the two half-rings are interconnected by two
toggle mechanisms, each constituted by a pair of arms, hinged
together about a hinge and hinged to the half-rings via
~0 respective hinges, fulcrums for levers being formed about two
hinge axes fixed to the flange by a part.
The sealing ring may have a trapezium-shaped right cross-
section and is engaged around a lip on the split ring,
deformation of the split ring du~ing operation of the actuator
means deforming the sealing ring until it is applied in
leakproof manner against the bag rim.
Advantageously, the bag rim is made of a plastic material
that is rigid enough to accept the clamping force developed by
the sealing ring with which its inside face of generally
hyperbolic section co-operates when the bag is assembled to the
bag-carrier.
To mount the actuator device on the bag-carrier, the bag
carrier has a groove delimited by a collar which surrounds the
stoma when the equipment is in use, and by two flanges which
are substantially parallel to each other and perpendicular to
the axis of the collar, a first one of the flanges co-operating
in retaining the sealing ring and a second one of the flanges
2~3~
serving firstly to fix the bag-carrier to the base plate and
secondly to guide and/or retain the actuator device on said bag
carrier.
This latter function is st simply provided by the second
S flange being provided with slots which receive studs on the
split ring.
In another embodiment, the sealing means is a split ring
shaped to have projections at its periphery suitable for co-
operating with hollows or a groove of complementary shape
provided in the bag rim.
In such an embodiment the split ring is mounted on the bag
-- carrier in a groove formed in an endpiece thereof, the endpiece
including a flange with a tapering outside face suitable for
co-operating with a complementary face on the rim of the bag,
:5 and the actuator means is advantageously constituted by a lever
~hich displaces one of the ends of the split ring which
includes tabs or the like for engaging recesses of the lever
for the purpose of locking the lever in the position where the
bag is assembled to the bag-carrier.
In yet another embodiment, a single elastically deformable
member acts both as the actuator device and as the sealing
gasket, either on its own or by means of a sealing ring which
is directly associated therewith.
In one form of this embodiment, the member used is a ring
suitable for deformation by means of a fluid (pneumatic or
hydraulic) to increase its radial size when sealing the rim of
the bag to the bag-carrier.
In another form, the member is a toroidal chamber that is
inflatable and deflatable via a valve associated therewith,
said chamber itself constituting the sealing gasket, or in a
variant including an auxiliary sealing gasket.
As inflation means, the invention provides for a syringe
type device or else 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 to and from the chamber to be
inflated.
2~f~
Although it is a "two-part" type of system, the stoma
apparatus of the invention is thus constituted by at least
three items, namely: a bag carrier including a sleeve or a
collar; a bag having a relatively rigid rim; and an elastirAll
5 deformable member acting to preve~nt the rim of the bag moving
relative to the collar whenever the dimensions of the
deformable member are increased by mechanical, hydraulic, or
pneumatic actuator means.
In another embodiment of equipment of the invention, the
radial size of the sealing means comprising a sealing ring E~
se mounted to move radially relative to the sleeve of the bag-
- carrier is increased by being moved outwardly relative to thesleeve when the volume of a chamber adjacent to the ring is
increased.
:~ In a first form of this embodiment, the volume of the
chamber adjacent to the sealing ring is increased by inserting
a quantlty of fluid into the chamber in addition to the fluid
that it contained initially.
The insertion may be obtained by mechanical means e.g.
locally deforming a space of given volume by means of a lever
or the like, or in a variant by directly or indirectly
conveying a hydraulic or a pneumatic fluid into said chamber
from a source of fluid under pressure e.g. a syringe, a
pump, a supply of compressed gas, etc. ... .
The space may be delimited by a wall of resilient material
against which a piston is disposed to act, displacement of the
piston being controlled by actuating one or more levers.
The space may be enclosed in a box fixed to the bag-
carrier by brackets, and the brackets may have hooks suitable
for co-operating with complementary hooks on the piston
actuating lever(s) to hold said lever(s) in a position
corresponding to the bag being assembled to the bag-carrier.
In another embodiment, the space for feeding the variable
volume chamber adjacent to the sealing ring via the channels
may be connected to a source of fluid under pressure by a valve
device via a flexible deformable tube.
7 2~3~6
In another form, the valve device is connected to a non-
return valve, itself connected to a bellows type tube for
inflating the spaoe by means analogous to a pump.
In another embodiment of the invention, the sealing means
is a hollow or solid component includiny lips or membranes for
fixing to a body integral with the bag-carrier, and including
means for changing the volume of the chamber adjacent to the
sealing ring.
In one form of this embodiment, the body has channels
opening out into an enclosure whose volume can be changed
and/or into which a fluid under pressure may be injected.
--- In yet another embodiment, the radial size of the sealing
means is increased by a split ring acting by a wedging effect
via a washer adjacent to the sealing means, which sealing
:~ means is then advantageously constituted by a toroidal member
having a somewhat trapezium-shaped right cross-section and
enclosing an angular cavity filled with a liquid or gaseous
fluid.
In a variant, the sealing means is a solid member of
cellular material having an integral surface skin obtained
using techniques known in the manufacture of foam or cellular
type materials in the elastomer and/or plastomer industry.
In another variant, the sealing means is a solid or hollow
ring having a polygonal right cross-section and made of a
relatively soft elastomer type material, advantageously having
hardness lying in the range 20 to ~0 in the Shore A scale.
When the equipment includes a split ring for increasing
the radial size of the sealing means, the ends of the ring
advantageously include actuator lugs enabling the ~nds to be
moved towards each other, together with mea~s e.g. latches
hooks, catches, or the like for holding said split ring in its
open position or in its closed position.
In addition, the invention also provides for associating a
tongue with one of the lugs of the split ring, the tongue
being slidably received in a passage through the other lug to
guide the lugs relative to each other during motion towards
each other and away from each other.
8 2 ~
Whatever the embodiment, the inve~tion provides for the
sealing means to be associated with a support that may be
mounted to rotate relative to the sleeve of the bag-carrier,
such that once the bag has been applied thereto, it can be
pointed in any direction relative to the bag-carrier as is
sometimes desirable to increase user comfort.
In a variant, the support for the sealing means is t
mounted to rotate relative to the bag-carrier sleeve, and the
direction in which the bag points relative to the bag-carrier
can be varied after the bag has been ~ounted on the bag-carrier
by slightly reducing the radial dimension of the sealing means,
thereby reducing the pressure with which the bag is applied
aga1nst the bag-carrier.
In an advantageous embodiment, the bag-carrier has a
5 flange which holds the sealing means against axial
displacement, with the inside diameter of the rim on the bag
belng smaller than the outside diameter of the flange but
larger than the outside diameter of the sealing means.
The invention also provides a bag for collecting body
wastes and/or fluids, in particular for enterostomy or
urostomy, and suitable for forming a part of equipment as
defined above.
The invention also provides a bag-carrier suitable for
forming a part of such a system.
In the accompanying drawings:
Figure 1 is a diagrammatic perspective view of a bag-
carrier and a bag constituting equipment of the invention and
shown at a distance from each other;
Figure 2 is a fragmentary longitudinal section through a
bag-carrier and a bag constituting a first embodiment of
equipment of the invention;
Figure 3 is a view analogous to Figure 2 showing the bag
applied to the bag-carrier but prior to being fixed thereto;
Figure 4 is a view analogous to Figure 3 but after the bag
has been fixed to the bag-carrier;
Figure 5 is a fragmentary view analogous to Figure 3 but
applicable to a different embodiment;
Figure 6 is a view analogous to Figure 4 but corresponds
to the embodiment shown in Figure 5;
Figure 7 is a view aralogous to Figures 4 and 6 but
applies to yet another embodiment;
Figure 8 is an elevation view of a component part of yet
another embodiment of the invention, said part being shown in a
first condition;
Figure 9 is a view analogous to Figure 8, showing the part
in another condition;
Figure 10 is a fragmentary perspective view of said part;
Figure 11 is an elevation view of a component part of yet
another embodiment of apparatus of the invention, the part
:5 being shown in a first condition;
Figure 12 is a view analogous to Figure 11, but showing
the part in another condition;
Figure 13 is a fragmentary view analogous to Figure 11 but
on a larger scale and showing a variant;
Figure 14 is a fragmentary view analogous to Figure 12,
but for the variant shown in Figure 13;
Figure 15 is a diagrammatic section on line 15-15 of
Figure 14;
Figure 16 is a diagrammatic elevation view of another
'5 embodiment of a bag-carrier for apparatus of the invention;
Figure 17 is a section on line 17-17 of Figure 16, but on
a larger scale;
Figure 17A is a view analogous to Figure 17, but showing a
variant embodiment;
Figure 17B shows how a bag is installed on a bag-carrier;
Figure 18 is a section on line 18-18 of Figure 16;
Figure 19 is a fragmentary view analogous to Figure 16 but
showing another embodiment;
Figure 20 is a section view on line 20-20 of Figure 19;
Figure 21 is a view analogous to Figures 16 and 19, but
for yet another embodiment;
lO ~0~36~
Figure 22 is a section view on line 22-22 of Figure 21;
Figure 23 is a view analogous to Figures 19 and 21, but
for another embodiment;
Figure 24 is a section view on line 24-24 of Figure 23:
S Figure 25 is a sec~ion view on line 25-25 of Figure 23,
but on a larger scale;
Figure 26 is a section on line 26-26 of Figure 23;
Figure 27 is a diagram~atic view analogous to that of
Figure 25, but showing a variant emrodlment;
'O Figure 28 is a view analogous to that of Figures 19 and
21, but for yet another embodiment;
~ Figure 29 is a diagrammatic fragmentary section on line
'9-29 of Figure 28, and on a larger scale; and
~igure 30 is a view analogous to Figure 28, but showing a
, arlant .
Reference is made lnitially to Figures 1 to 4 which show a
first embcdiment of two-part type stoma equipment of the
inventlon, i.e. equipment including bag-carrier 10 for fixing
around an artificial opening in the body of a user by
appropriate fixing means. Such means may comprise a base plate
12 provided with adhesive or with a pressure-sensitive adhesive
rubber (known per se) that is protected for as long as the
equipment is not in use by means of a peel-off film 11 (Figure
`S 3). In a variant and/or in addition, the bag-carrier 10 may be
held on the body of the user by means of a belt (not shown) or
by analogous means. The bag-carrier lO whose base plate 12
includes an opening 13 that surrounds the stoma when the
equipmen~ is in use also includesa~ adhesive composite sheet 14 on the
face of the base plate 12 opposite to its face that comes into
contact with the body of the user. The composite sheet 14
contributes to protecting the peristoma region and to holding
the plate against the skin of the user. An endpiece 16
comprising a sleeve or coll æ 17 which is cylindrical a~out an
3S axis A has a first flange 15 which is fixed to the face of the
composite sheet 14 that is opposite to its face connected to
the base plate 12, and a second flange 18 which is
substantially parallel to the flange 15 (both of which are
perpendicular to the axis A), with the two flan~es 15 and 18
together defining a groove 19.
The groove is designed to receive a deformable ring 20,
e.g. a split ring comprising a substantially plane body 21 of
circular outline delimited on the inside by a lip 22 at right
angles having a cylindrical inside surface 23 and a tapering
outside surface 24 (Figures 2 and 4). According to the
invention, the ring 20 is the device which serves to hold the
bag 20 on the bag-carrier 10 by increasing its size (with size
being increased in a manner explained below). The ring is held
- and guided relative to the flange 15 by studs 25 on the ring
that are received in slots 26 in the flange 15.
The lip 22 of the deformable ring 20 carries a sealing
gasket or ring 30 made of resilient material (advantageously a
thermoplastic elastomer (TEP)) having a right cross-section
that is generally trapezium-shaped and whose thickness parallel
to the axis A is substantially equal to the distance between
the flanges 15 and 18 minus the thickness of the split ring,
such that the sealing ring 30 is also received in tne groove
19. The largest nominal outside diameter of the sealing ring
30 is less than the smallest diameter of the rim 41 of the bag
40 so that the bag can be installed with the bag rim
surrounding the sealing gasket or ring 30 without applying
pressure to the zone surrounding the stoma. It is then
possible to fix the bag 40 to the bag-carrier 10 by deforming
the split ring 20 to increase its dimensions, thereby also
increasing the dimensions of the sealing ring 30 so that it
bears against, and has a clamping effect on, the inside surface
42 of the bag rim 41 which has a generally hyperbolic right
cross-section facing the inside of the bag 40 and which is made
of a relatively rigid material, e.g. polypropylene or high
density polyethylene.
To do this and bring the equipment into the condition
shown in Figure 4, the invention provides for associating the
deformable ring 20 with appropriate actuator means. In the
embodiment shown and described, the actuator m~ans 50 is
12 2~3~
constituted as a lever suitable for moving the ad;acent ends of
the split ring apart and for locking the equipment in this
operating position, which can be done most simply by making
tabs or the like at the periphery of the split ring co-operate
S with recesses on the inside edge of the lever.
Performing the opposite operation on the lever 50, i.e.
returning the split ring 20 to its initial, small-sized
condition makes it possible to withdraw the bag 40 from the bag
carrier 10.
O The bag 40 for collecting body wastes and/or fluids
suitable for evacuation through the endpiece 16 may be of the
- disposable type, or it may be emptiable. In either case it is
made by fixing an outwardly-directed flange 43 on the bag rim
~1 to the bag per se by gluing, welding, or the like. The bag
:, is constituted by a sheet of polyethylene, or of PVC, or of
~olyamlde, or else by a composite barrier sheet of the
polyethylene/EVA/PVC/EVA/polyethylene type e.g. those known
under Dow Chemical's trademark Saranex, or a composite sheet of
the EVA/EVA vinylidene polychloride copolymer type e.g.
those known under Grace's trademark Cryovac, or indeed a
composite sheet of the EVA/EVOH/EVA type, or of an analogous
material.
Operation of the equipment is simple and reliable, and
highly satisfactory operation has been obtained for an
embodiment comprising an endpiece 16 having a diameter of about
55 mm, a bag rim having an inside diameter of 68 mm, and
a sealing gasket or rim having an outside diameter of 66
mm.
Reference is now made to Figures 5 and 6 which are
diagrams of another embodiment. In this embodiment, the bag
40' is welded or glued to the bag rim 41' that projects towards
the inside of the bag and that is shaped to have an inwardly
tapering inside surface 42' whose larger-diameter end is
indented to form hollows or a groove 45. Radial projections 46
of a deformable member 20' mounted on the bag-carrier in a
groove 19' of its endpiece 16' are suitable for co-operating
with the hollows or groove 45. The endpiece has a flange 15'
2~3~6
13
analogous to the flange 15 of the above-described embodiment
and is designed to co-operate with the bag rim 41' by means of
a rib 47 whose tapering outside surface 48 is complementaly to
the inside surface 42' of the bag rim. In this embodiment, the
member 20' which is enlargeable by being deformed is likewise a
split ring made of plastic and is advantageously integrally
molded with actuator means 50 enabling its dimensions to be
increased so as to go from the condition shown in Figure S to
the condition shown in Figure 6 which is the condition in which
the t)ag 40' is fixed to the bag-carrier.
In order to install such equipment, the bag-carrier is
- initially fixed to the body of the user by means of a base
plate 12 provided with an adhesive or with an adhesive rubber
and by the sheet 14 (naturally after the protective film 11 has
-~ been removed). The bag 40' is installed by being presented to
the bag-carrier with the bag rim 41' being engaged on the rib
47 while applying practically no pressure to the zone adjacent
to the stoma. Actuating the lever 50' to increase the
dimensions of the ring 20' causes the projections 46 thereon to
penetrate into the hollows or groove 45, thereby holding the
bag 40' in leakproof manner on the bag-carrier by co-operation
between the complementary tapering surfaces 42' and 48.
The bag 40' is separated from the bag-carrier by the
opposite procedure of unlocking the lever S0' and then moving
it in the opposite direction to that described above.
The invention is not limited in any way to the embodiments
and the application described above. Thus, as shown in Figure
7, the invention provides for embodiments in which the bag is
fixed to the bag-carrier by deformlng a member whose size is
increased by means of a hydraulic or a pneumatic fluid. In the
embodiment shown, the bag 60 has an inwardly-directed bag rim
61 whose inside surface 62 is curved, e.g. following a
hyperbolic outline. The outside surface 63 of a sealing ring
64 of trapezium-shaped right cross-section is suitable for co-
operating with the inside surface of the rim. The sealing ringis made of resilient material, e.g. a thermoplastic elastomer
(TEP) and it is connected by an isthmus 65 to a toroidal
14 2~3~
chamber 66 received in the groove 70 formed on an endpiece 71
of the bag-carrier, which groove extends between a cylindrical
collar about an axis A, an outside flange 67, and an inside
flange 68, which flanges are substantially parallel to each
other and perpendicular to the axis A. The resiliently
deformable chamber 66 is advanta~eously made of the same
material as the sealing ring 64 and is connected to an endpiece
72 having a through channel 73 including a valve (not shown).
The operation of this embodiment is immediately obvious
0 from the above. Once the bag-carrier~has been fixed to the
body of the user and the chamber 66 has been deflated, the bag
- 60 is presented to the bag-carrier with the bag rim 61 being
easily installed on the sealing ring 64. The endpiece 72 which
is fixed to the bag-carrier is then engaged with pneumatic or
hydraulic inflation means 66' e.g. a syringe device, a
supply of gaseous fluid under pressure e-~- a portable
compressed air cylinder, or a device in which displacing a
lever serves to transfer a given volume of liquid into the
chamber 66 via the channel 63. As a result, the volume of the
chamber 66 increases and the ring 64 is pressed against the bag
rim 61 so as to fix the bag 60 in leakproof manner to the bag
carrier.
The opposite procedure is applied to separate the bag from
the bag-carrier once the pressure of the pneumatic or hydraulic
fluid in the chamber 66 has been removed.
Reference is now made to Figures 8 to lO which show a
preferred embodiment of equipment of the invention in which the
device for fixing the bag to the bag-carrier is a split ring
made of plastic and integrally molded with the ring actuator
means. In this embodiment, the structure of the bag and the
structure of the bag-carrier are substantially the same as the
embodiment described with reference to Figures l to 4 and the
same references designate parts that are similar. As can
clearly be seen in Figures 8 and 9, the ring 80 is split into
two diametrically opposite regions 81 and 82, with the two
resulting half-rings 80a and 80b being interconnected by a
lever 83 and a toggle type mechanism 84 whose two branches 85
2 ~ ~ 3 ~ ~ 6
and 86 are hinged together about a hinge 87 and are also hinged
about respective hinges 88 and 89 to the half-ring 80a and to
the half-ring 80b, with the hinge 88 also constituting the
fulcrum of the lever 83. The lever is integrally molded with
the split ring 80 while the ring is in its largest di~ension
configuration as shown in Figure 9, i.e. the configuration in
which the lever is moved down to come into contact with the arm
86 which then lies on substantially the same circle as the body
21 of the ring (which also applies to the arm 85), whereas in
0 the small dimension condition, as shown in Figure 8, the lever
83 and the arms 85 and 86 project from said ring.
~ To make the lever 83 easier to actuate and to make the
equlpment more maneuverable, the lever and the hinge zones 88
and 89 are molded to be greater in thickness than the remainder
-5 of the body 21, the lip 22, and the web constituting the arms
85 and 86, which arms are also curved to correspond to cut-outs
90 and 91 in the half-rings 80a and 80b for receiving said arms
(Figures 9 and 10).
This embodiment operates in similar manner to the
embodiment described with reference to Figures 1 to 4. Once
the bag-carrier is fixed to the body of the user by means of
its base plate 12, the lever 83 is moved to the condition shown
in Figure 8: in this condition, the bag 40 may be presented to
the bag-carrier and the bag rim 41 may be applied without force
and without difficulty onto the sealing ring 24. The lever 83
is then caused to pivot in the direction of f about its hinge
88 (Figure 8), thereby displacing the hinge 87 in the direction
of arrow ~, thus moving ap OE t the two ends of the half-rings
80a and 80b adjacent to the split 81. When the lever 83 has
finished pivoting, the condition is as shown in Figure 9 where
the sealing ring 24 is in contact with the bag rim 41, thereby
fixing the bag in leakproof manner on the bag-carrier.
To separate the bag from the bag-c OE rier, the lever 83 is
pivoted in the direction opposite to that described above,
thereby changing from the condition shown in Figure 9 to the
condition shown in Figure 8, thus restoring the split ring 80
to its small-sized condition and the resilient sealing ring 24
16 ~ f~
to its initial condition, thereby enabling the bag rim 41 to be
withdrawn by moving it away from the bag-carrier.
Figures 11 and 12 show another emhodiment similar to that
of Figures 8 to 10, but in which the deformation means are
doubled up, thereby making operation more flexible, but
remaining identical in principle to the emb3diment shown in
Figures 8 to 10. In this embodiment, the actuator device is a
ring lO0 which is split at two diametrically opposite regions
81 and 82, thereby providing two half-rings lOOa and lOOb which
0 are interconnected by two toggle mechanisms each constituted by
a pair of arms referenced 95 and 96 for the first mechanism and
9S' and 96' for the second mechanism, with each of the
mechanisms being suitable for actuation by a respective lever
103 or 103'. AS is clearly visible in Figures 11 and 12, the
rms 95 and 96 are hinged to each other about a hinge 97 while
the arms 95' and 96' are hinged to each other about a hinge
97' ~he hinges to respective ones of the half-rings lOOa and
lOOb are referenced 99 and 99', respectively. In addition, in
this embodiment, the levers 103 and 103' are hinged to pivot
~ about two axes referenced 98 and 98', which axes are fixed to a
flange analogous to the flange 15 of the preceding embodiment
by means of a part 104. In this embodiment, the size of the
ring lO0 is increased by actuating the two levers 103 and 103'
in the directions of arrows ~ and ~', thereby arriving at the
configuration of Figure 12, and thus retaining a bag on the bag
carrier, whereas pivoting the levers in the opposite directions
serves to release the bag from the bag-carrier.
In the embodiment shown diagrammatically in Figures 13 to
15, the arms 95 and 95'a (analogous to the arms 95 and 95' of
the preceding embodiment) are shaped to provide respective
horns 105 and 105a of narrower thickness than the arms from
which they extend (Figure 15), thereby enabling them to overlie
a peripheral margin 44 of the flange 43 on the bag rim 41
(Figure 14) when the bag is fixed to the bag-carrier. By
35 having horns 105 and 105a suitable for co-operating with the
margin 44 of the flange 43, retention of the bag on the bag
carrier is enhanced, particularly as the bag fills up and its
weight increases.
17 2 ~ U
Reference is now rnade to Figures 16 to 18 relating to
another embodiment. In these figures, the bag 120 is fixed to
the bag-carrier 110 (having an adhesive base plate 112
protected by a film 111) by increasing the radial size of a
5 sealing means 122 comprising a sealing ring E~_ se 123 having a
right cross-section that is somewhat trapezium-shaped with two
resilient flexible membranes or lips 124 and 125 projecting
therefrom and fixed to two separate walls 126 arld 127 of the
bag-carrier, thereby delimiting a chamber 128 which is adjacent
to the sealing ring 123. The walls 126 and 127 are provided on
a body 129 which is integral with a sleeve 115 of the bag
carrier (analogous to the sleeve 17 of the embodiments of
Figures 1 to 4) or which are mounted to rotate relative thereto
by means of a rib 130 received in a groove 131 in said sleeve,
-~ ~ith the mer~rane 124 being fixed to the wall 126 by a ring 135
which clamps on its inside against the wall 126 by bearing
against a lip at right angles 136 which is parallel to said
wall (Figure 17), while the m~mbrane 125 is secured to the
"mushroom-section" wall 127 by a spring clip 138. The assembly
is protected by a flange 140 which is integral with the sleeve
115 and which projects from the free end thereof that is
distant from its flange 114, and eY~tends substantially parallel
thereto. To change the volume of the chamber 128 (thereby
displacing the sealing ring 123 in the direction of arrow _
thus increasing its radial si7e so that it bears against the
bag rim 121 when the bag is applied to the bag-carrier), the
invention provides for the chamber to communicate with a space
of given volume 146 via channels 145. In the embodiment
described and shown, the space 146 is formed by an enclosure
147 in a box 148 whose peripheral edges 149 and 150 are fixed
to portions 151 and 152 of complernentary shape on the body 129.
The edges 149 and 150 are also clamped via a rolled edge which
is crimped to the free edges of the enclosure 147. Two
brackets 153 and 154 project from the body 129 symmetrically
about a diametral plane ~ of the equipment and serve to hold
the ends of the box 148 by means of ribs having substantially
triangular right cross-sections 148a and 148b of the box
2 ~
18
interfitting (Fiyure 18) in grooves of complementary shape on
the brackets, with hooks 155 and 156 on said brackets
preventing radial outwards displacement of the box, the
brackets also having hooks 157 and 158 on their outside
surfaces.
The box 148 slidably receives a piston 160 suitable for
being displaced radially in response to actuation from one or
two cam levers 161 and 162, which levers have operating
surfaces 167 and 168, are provided with respective arms 163 and
0 164, and are pivotally mounted on the box 148 about axes 165
and 166.
To implement such equipment, the bag-carrier 110 is
initially fixed to the body of the user by means of a base
plate 112. To install a bag 120, the bag is presented to face
the bag-carrier 110 and the bag rim 121 is placed around the
sealing ring 123 without applying pressure to the region around
the stoma, i.e. without causing the user any pain. The two
levers 161 and 162 are then pivoted about their axes 165 and
166 as shown by arrows i and i in Figure 16, thereby displacing
' the piston 160 towards the axis A of the bag-carrier, i.e. in
the direction of arrow F in Figures 16 and 17. This piston
movement deforms the enclosure 147 and the fluid (gas or
liquid) contained inside the space 146 is conveyed by the
channels 145 to the chamber 128 whose volume increases, thereby
~'5 giving rise to radial displacement such that the sealing ring
123 moves away from the sleeve 115. When the sealing ring
comes into contact with the bag rim 121 (made of relatively
rigid material) it bears thereagainst, thereby obtaining the
desired leakproof fixing of the bag 120 on the bag-carrier 110.
The system is maintained in its operated condition by the fact
that the arms 163 and 164 of the levers 161 and 162 are
provided with hooks at their ends that are complementary to the
hooks 157 and 158 on the brackets 153 and 154. To remove the
bag 120 from the bag-carrier 110, the opposite procedure is
35 performed, in which the levers 161 and 162 are unlocked and
then moved in the direction opposite to that described above.
2 ~ 6 ~
In the variant shown in Figures 17A and 17B, the inside
diameter ~1 of the bag rim 121 is smaller than the outside
diameter ~2 of the flange 140 but larger than the outside
diameter ~3 of the sealing ri~g 123, with the length of the bag
rim lZl (as measured parallel to its axis of symmetry) being
less than the thickness of the ring 123. To install the bag,
advantage is taken of the deformability of the bag rim 121
which is made of thermoplastic material. The rim is inserted
in the gap between the inside face of the flange 140 and the
lip 136 (Figure 17B) in much the same way as a tire is
installed on the rim of a wheel, but naturally without the same
- difficulty. This ensures that the bag rim 121 is properly
positioned around the sealing ring 123 without any danger of
the bag rim moving axially while leaving it very free in
:5 rotation about the sealing ring, thus making it possible to
fix the bag in leakproof manner without any risk of error in
placing the bag relative to the bag-carrier.
The structure of the equipment shown in Figures 19 and 20
is very similar to that described above, and corresponding
parts are given the same references. However, in this
embodiment, the piston 160a is subjected to the astion of a
single pivoting lever 170 whose hook 171 at its end opposite to
its pivot is suitable for co-operating with the hook of
complementary shape 158 on the bracket 154.
In the embodiment shown in Figures 21 and 22 (where parts
that correspond to those of Figures 16 to 18 are given the same
references as on those figures), the piston 160b is not mounted
to move radially, but to move in a direction parallel to the
axis of the sleeve 115 when a lever 172 is actuated to cause
said piston 160b to penetrate to a greater or lesser extent
inside the box 148'.
In the embodiment shown in Figures 23 to 26, parts which
are identical to those of the embodiment of Figures 16 to 18
are given the same references as therein, and the channels 145
connect to the chamber 128 to an enclosure or space 175 which
is closed by a plug 176. The enclosure 175 is fitted to a
flexible deformable tube 177 having a valve 178 placed thereon
2Q~36~6
which is in turn connected to an endpiece 179 of the conical
type or of the Luer type for connection to a souroe of fluid
under pressure. The valve 178 is provided with a vent 180 for
releasing air when the endpiece 179 is in a first position,
while the valve 178 allows fluid to be inserted into the
enclosure 175 for controlling radial displacement of the
sealing ring 123 against the bag rim 121 when the endpiece is
in a second position. As in the preceding embodiments, the bag
rim is rigid enough to accept the sealing pressure applied to
0 it in this way. To make the equipment easier to use, the
invention provides for ~he concertina-like flexible tube 177 to
~ be held in place close to the bag-carrier on which it is
installed by means of a clip 181 (when the bag is installed on
the bag-carrier) while allowing the tube 177 to be moved away
:. for the purpose of connecting the endpiece 179 to ~he source of
fluid under pressure.
In the embodiment shown very diagrammatically in Figure
27, which is mostly identical to that described immediately
above with reference to Figures 23 to 26, a non-return valve
185 for retaining pressure and a bellows tu~e 186 are installed
between the valve 178' and the enclosure 175 into which the
channels 145 open out. The valve 185 and the bellows tube 186
constitute a pump system for inflating the chamber 128 via the
enclosure 175 and the channel 145. In this embodiment, the
Z5 radial size of the sealing ring 123 is increased by applying a
pushbutton 187 on the valve 178' (e.g. by screwing it thereon)
and then by deforming the bellows tube 186 longitudinally like
a pump, with inflation pressure, and consequently the pressure
providing leakproof application of the bag-carrier 110 against
the bag 120, being maintained after the pushbutton 187 has been
withdrawn from the valve 178', and with the bag being dis-
assembled from the bag-carrier by putting the enclosure 175
into communciation with the atmosphere, most simply by with-
drawing the plug 176 by unscrewing it.
In the embodiment shown in Figures 28 and 29 the radial
size of the sealing ring 128 is obtained by wedge type
mechanical means. More precisely, in this embodiment, the
21 2~3~'~&
invention provides a body 129' performing the same role as the
body 129 of the embod~ment of Figures 16 to 18 ln ~he form of a
cylindrical wall 190 suitable for fi~ing to the sleeve 115
either without any possibility of relative motion or else, in a
variant, mounted with the possibility of rotating relative to
said sleeve by means of a rib 130' received in a groove 131' in
the sleeve 115. The wall 190 is integral with a base 191
extending substantially perpendicularly to the axis A of the
equipment and which has an outside face 192 that slopes
relative to the axis. A washer 193 of triangular right cross-
section is placed on the base 191 concentrically with the wall
l90 and adjacent thereto. The washer co-operates with the
flange 140 of the sleeve 115 to form a groove in which the
sealing ring 123 is received. The right cross-section of the
~5 sealing ring is somewhat trapezium-shaped, and the sealing ring
is advantageously made of an elastomer-based resilient material
(whose hardness preferably lies in the range 20 to 40 on the
Shore A scale) or else of a plastomer material in which case it
is particularly appropriate to use a foam or cellular material
having an integral skin.
Whatever the material chosen, the sealing ring 123 is
either a "solid" body, or else in a variant it is a "toroidal"
body enclosing a cavity 194 filled with an incompressible fluid
such as water.
In this embodiment, in order to increase the radial size
of the sealing ring 123, the invention provides an operating
member 195 which is associated with the bag-carrier 110 and
which is constituted by a split ring of triangular right cross-
section which is applied to the base 191 where it is maintained
in its open condition (shown in Figure 28) by co-operation
between a hook 196 provided at the end of a tongue 197
projecting from one of tlle ends of the ring and a catch 198
provided on the opposite end of said ring, with the tongue 197
being suitable for sliding through an opening l99 in the end
35 lug 200 on which the catch 198 is mounted. The end of the ring
195 opposite to the end carrying the lug 200 is shaped to have
a lug 201, and in the vicinity of this lug the tongue 197
carries a tooth 202.
22
To operate the equipment, once the bag-carrier has been
fixed to the body of the patient, a bag 120 is applied to the
bag-carrier with the bag rim 121 facing the sealing ring 123,
or else in a variant it is installed in the manner described
above with referenoe to Figures 17A and 17B. This is done
while the ring 195 is in its open condition as shown in Figure
28 (i.e. the hook 196 is engaged with the catch 198), the ring
therefore does not co-operate with the washer 193 until the
lugs 200 and 201 are moved towards each other so that the
tongue 197 slides in the passage 199 and the ring 195 engages
beneath the washer 193. The sealing ring 123 as held in place
~- by the flange 140 and by the cylindrical wall 190 then deforms
in the direction of arrow m, i.e. its radial size increases
untll it comes into contact with the bag rim 121 which is made
.~ of a relatively rigid material so as to constitute a thrust
surface providing sealing and locking for the bag on the bag
carrier.
The assembled condition is retained so long as the tooth
202 on the tongue 197 co-operates with the catch 198 to retain
the member 195 in its closed position, and releasing the tooth
202 relative to said catch enables the resilient member 195 to
return to the condition shown in Figure 28 in which the bag 120
can be removed from the bag-carrier 110 since the sealing ring
123 also returns to its initial condition.
In the embodiment shown diagrammatically in Figure 30, a
tooth 202' (analogous to the tooth 202 of the embodiment shown
in Figures 28 and 29) is associated with the lug 201 and is
suitable for co-operating with a catch 198' (analogous to the
catch 198) provided on the lug 200. In this embodiment which
operates in the same way as that described above with reference
to Figures 28 and 29, the tongue 197 having a harpoon-like tip
203 slides through the passage 199 as the lugs 200 and 201 move
towards each other under pressure from the user's fingers until
the tooth 202' engages the catch 198', with the tooth 202' being
disengaged from the catch 198' merely by lifting the end of the
tongue 204 carrying said tooth, thereby enabling the resilient
member 195 to return to its condition shown in Figure 30.
2 ~
23
By allowing the control ~ember 195 to rotate freely about
the axis A of the equipment, when in the open conditlon as
shown in Figures 28 and 30, the user is given the advantage of
positioning the lugs 200 and 201 in the best possible position
for user comfort and/or for operating the lugs.
... .
~5
