Apparatus for tending a stoma

The subject matter of the invention is an apparatus for tending a stoma comprising a base plate made of a hypoallergic material or of an adhesive film and a snap ring to which a bag for taking up the excreta is attached with a snap closure. The connection between the base plate and the snap ring is a flexible cylindrical connector piece of little height and a diameter which compared with the base plate is as large as possible. The three-dimensional connector piece extends normal to the base plate and may have also the form of a steep truncated cone.

BACKGROUND OF THE INVENTION 
The tending of a stoma--i.e. of an artificial outlet for stool (ileostoma, 
colostoma) or urine (urostoma)--is effected nowadays mainly by means of 
disposable adhesive bags. 
Apart from the (rare) allergy to the adhesive, the adhesive bags involve 
the disadvantage that when being replaced they tear off or "strip" the 
uppermost epithelium layers of the skin until it wets and becomes 
extremely susceptible to irritations and infections. Skin problems around 
the stomata render the application of adhesive bags impossible in many 
cases, above all when the stripped skin is additionally exposed to 
fermentatively aggressive excreta (ileostomy, urostomy) or infectious 
material (fistulae). 
To protect the skin in the immediate vicinity of the stoma, there have been 
developed base plates of a hypoallergic material, comprising a thin 
elastic film on the outside of the base plate. The base plates may remain 
in the applied position for several days. Onto this artificial skin the 
bags are adhered and are also to be replaced there once or several times a 
day. 
This solution is extremely convenient to the patient (all is flat and 
flexible) and theoretically represents actually the ideal solution. In 
practical use, however, there result serious disadvantages. During sitting 
and stooping, folds are forming in the base plate so that, when the bag is 
being replaced, an odor and liquid-tight closure is made impossible. 
Moreover, the covering film of the base plate, which is very thin so as to 
have as far as possible the elasticity of the skin, is often damaged upon 
stripping off a bag. The base plate thereby becomes unserviceable and must 
prematurely be replaced. 
To overcome these said disadvantages, it has therefore been suggested to 
glue directly onto the base plate the semi-rigid ring of a snap closure 
whose likewise semirigid counterpart is provided at the bag. The closure 
engages according to the snap-fastener principle and can be replaced. This 
system solves very well the replacement of the bags but involves other, 
very inconvenient disadvantages: 
1. The closure becomes practically rigid by the junction of the two 
semi-rigid rings. This rigid closure is very uncomfortable during sitting 
and stooping--quite particularly when large-size stomata, requiring 
largesize closures, are involved. The closure exerts a painful pressure on 
the skin, it detaches, due to its rigidity, the base plate from the 
elastic skin and finally "uses up" the base plate so that it has to be 
replaced more often than would be necessary with a fully elastic closure. 
2. On account of the inconveniencies during wearing, the patient cannot be 
expected to put up with a ring larger than absolutely necessary. There is 
thus required a considerable number of ring sizes both for the base plate 
and for the bag (at present 5 sizes are commercially available). 
Production and distribution are thereby rendered more expensive. 
3. The tending (care) of the most critical place, namely the skin ring 
between the circumference of the stoma and the inner edge of the circular 
opening of the base plate --e.g. by means of a coating paste--is 
complicated if narrow snap rings are involved. Wide rings allow a good 
tendance of that critical skin ring but ar bulky and very uncomfortable 
due to their rigidity. 
4. Moreover, excreta are regularly gathering in the circular niche between 
base plate and snap ring. They can be removed only with difficulty, 
decompose quickly and lead to additional undesirable odors. They render a 
clean replacement difficult or impossible. 
5. When the bag is being replaced, the new bag must be connected to the 
ring on the side of the body by pressure. Since said ring is firmly 
attached to the base plate, it is not possible to exert a counterpressure 
with the fingers. The pressure necessary for effecting the connection 
therefore fully acts on the at first mostly very sensitive abdomen of the 
patient. 
The original and correct concept of a flexible connection between base 
plate and bag has, on account of the difficulties in the bag replacement, 
been sacrificed thus in favor of a rigid connection, which admittedly 
enables a simple replacement but involves said disadvantages. 
With the particular object to overcome the disadvantages stated above under 
1. and 5., there has already been proposed a device (Product Information 
"Two-Piece Ostomy System", Hollister Inc., March 1982 and U.S. Pat. No. 
4,419,100 issued Dec. 6, 1983 to Alexander), in which the ring of the snap 
closure is not glued to the base plate but connected thereto through a 
connecting piece, which allows limited floating between the ring and the 
base plate. The connecting piece is extremely thin or flat resilient, 
annular web, connected at its outer circumference to the external portion 
of the back of the snap ring. The connection to the base plate is provided 
in the central area of the disk around the central opening. 
The connection between base plate and snap ring is in this known device 
still relatively rigid. In the rest position, the snap ring substantially 
lies directly against the base plate--an all round, even small space 
between base plate and ring is not provided in that arrangement. 
Consequently, the pressure discomfort to the user during stooping and 
sitting remains substantially unchanged. Since the annular web is fastened 
to the base plate at its central portion around the central opening, the 
possibility for the user to enlarge the opening so as to adjust it to his 
individual requirements is very restricted. In this device, too, various 
sizes are thus necessary, which renders the production, distribution and 
use more complicated and expensive. 
Moreover, from the fact that the annular web is fastened to the base plate 
at its central portion and that for the desired "floating" of the ring a 
considerable distance must exist between the inner adhesion point and the 
outer circumference of the web to which the ring is attached, it follows 
that a larger and thus more uncomfortable ring is required for a given 
stoma size compared with the previous art as described above. Also, the 
annular web needs to be made of a resilient material because a movement 
perpendicular to the base plate (resulting when the fingers are inserted 
between base plate and web) would not be possible with this construction, 
when using flexible but unresilient material. 
Finally, the snap ring of that device comprises on its inner side the 
necessary undercut for holding the counterpiece, which represents an 
undesired soil-catcher. Soil is collecting furthermore between the inner 
region of the bottom side of the ring and the connecting piece. 
As advantage of the device known from U.S. Pat. No. 4,419,100 there remains 
thus substantially only the fact that it is possible to tilt the ring so 
as to enable to put the fingers below the snap ring and to exert a 
counterpressure when pressing on the ring provided at the bag. However, 
due to the close fitting of the snap ring at the base plate, a pressure on 
the area surrounding the stoma cannot be completely avoided in that device 
either. In addition any movement with this extremely thin or flat device 
is only possible by stretching the resilient web, what creates traction 
forces irritating just the critical peristomal area and tending to 
separate there the base plate from the skin. As regards the movability of 
the parts relative to each other, the desired reduction of the number of 
sizes of the product and the demands concerning the requirements for 
cleaning, much is still left, however, to be desired. 
SUMMARY OF THE INVENTION 
It is the main object of the present invention to provide an ostomy device 
comprising a base plate, a snap ring means for detachably connecting a bag 
and a connector means connecting said base plate and said ring means, 
which device guarantees free mobility of the ring means in three 
dimensions without creating traction forces on the peristomal area thus 
providing high comfort to the patient. 
It is a further object of the present invention to provide an ostomy device 
as mentioned above which allows the distribution of the pulling or pushing 
forces created by the full bag or during exchange of the bag away from the 
small peristomal area to the large peripheral area where the skin is 
healthy. 
It is a further object of the present invention to provide an ostomy device 
as mentioned above which permits an optimal tending of the immediate 
circumference of the stoma. 
It is a further object of the present invention to provide an ostomy device 
as mentioned above which is free from soil catchers and therefore can be 
easily kept clean. 
It is still a further object of the present invention to provide an ostomy 
device as mentioned above which comprises only a relatively small ring 
means relative to the size of the stoma which is favorable for the comfort 
of the patient. 
It is still another object of the present invention to provide an ostomy 
device as mentioned above in which the opening in the base plate can be 
enlarged to a considerable degree and much wider than in the design 
according to U.S. Pat. No. 4,419,100 in accordance with the individual 
needs of the patients. 
These objects of the invention are achieved by an ostomy device for 
detachably securing a bag to a stoma comprising: 
(a) an apertured base plate, said base plate defining first and second 
circumferences, said first circumference being smaller than the second 
with a diameter that may be enlarged to a diameter of the stoma to be 
tended and a second larger circumference the diameter of which is about 4 
to about 20 mm smaller than the edge of the base plate for transmitting 
traction forces to the skin of the user at a maximum distance from said 
stoma, 
(b) a snap ring means substantially parallel to the base plate, the 
dimension of the aperture of the ring being determined by the diameter of 
the said second circumference said ring means detachably connecting with a 
snap closure a bag that receives the excreta from said stoma, and 
(c) a connector means made of a flexible but nonresilient plastic film 
material having a thickness of about 0.05 to about 0.3 mm connecting said 
base plate and said snap ring means, said connector means being 
cylindrical or having the form of a steep truncated cone and extending 
substantially perpendicular to said base plate, said connector means being 
attached to said base plate along said second circumference whereby forces 
transmitted to said base plate by attachment of said bag to said ring or 
by the movements of the user to said bag are absorbed by said base plate 
at said larger circumference to dissipate said forces at a maximum 
distance from said stoma.

DETAILED DESCRIPTION OF THE INVENTION 
In accordance with the present invention the interposition of extremely 
flat annular resilient web between faceplate and ring according to U.S. 
Pat. No. 4,419,100 is improved by interposition of a three-dimensional 
cylindrical, flexible but non-resilient connector piece. This cylinder 
extends essentially normal to the base plate. It has a diameter as large 
as possible with a given base plate. Within a reasonable range the snap 
ring can move freely without any construction-related forces in all three 
dimensions so allowing change of bags and bending and moving of the wearer 
whereby its construction guarantees the freedom of traction forces. 
This is a decisive advantage compared with the extremely thin or flat 
annular resilient web of the prior art, where every movement of said ring 
leads to construction-related traction forces to the peristomal area. 
The base plate (1) which preferably has a square form can be made of any 
one of the materials which are conventionally used for this purpose. It 
defines a first and a second circumference whereby said first 
circumference (13) constituing the opening (9) for the stoma is smaller 
than the second circumference (14) where the connector piece is fixed. The 
opening (9), may be enlarged to a diameter which corresponds to the 
diameter of the stoma to be tended. The second, larger circumference (14) 
is defined by the circle at which the connector piece (2) is attached to 
the base plate (1). The diameter of said second circumference is as large 
as possible in relation to the given size of the base plate, being only 
about 4 to about 20 mm smaller than the edge of the (square) base plate. 
The connector piece (2) between base plate (1) and the snap ring (3), which 
constitutes an essential element of the invention, can be cylindrical or 
have the form of a steep truncated cone. It consists of a flexible, but 
substantially non resilient plastic film material which has a thickness of 
about 0.05 to about 0.3 mm. The term "flexible" designates a material that 
can be bent easily and repeatedly but which is not elongated by traction 
forces. A material which is elongated by traction forces and restores its 
original length, when the force is released, is herein called "resilient". 
The connector piece (2) has a diameter which compared with the base plate 
(1) is as large as possible inter alia to ensure an optimum distribution 
of the traction force of the filled bag. Thereby the danger of a 
separation of the base plate from the skin is largely excluded, which 
would happen if the tension is concentrated on a small area. The 
cylindrical or slightly conical connector piece (2) has a height of at 
least 1 mm. A height of 3 to 15 mm is preferred. 
The connection of the flexible connector piece (2) to the base plate (1) is 
effected on an annular surface of the base plate which constitutes said 
second circumference (14) and which has a diameter only insignificantly 
smaller than that of the snap ring. Accordingly, the connector piece (2) 
has a cylindrical form or that of a steep truncated cone. Thus, an optimum 
utilization of the size of snap ring (3) and base plate (1) is achieved 
since the user can, depending on his individual requirements, widely 
enlarge the central opening (9) of the base plate(1) and is not confined 
in this connection by a central adhesion area between base plate and 
connector piece. 
Apart from a cylindrical embodiment of the connector piece, however, also a 
design of a steep truncated cone is possible and subject matter of the 
invention. That design is advantageous as regards the discharge from the 
stoma into the bag but comparatively disadvantageous for other reasons, 
above all when the cone comprises a greater taper in the direction of the 
base plate. 
The axis (6) of the flexible cylindrical or conical connector piece (2) can 
be perpendicular to the base plate, or it may be advantageous to direct it 
obliquely downwards so that the formation of folds is minimal and excreta 
can flow off spontaneously. For the same reason it is preferred that the 
edge (11) between base plate (1) and connector piece (2) is rounded off; 
see FIG. 2. 
In the device of the invention a snap ring (3) for detachably connecting a 
bag is provided at the flexible connector piece (2) before the base plate 
(1), to which ring the conventional bags with snap closure (5) can be 
attached and replaced without difficulty. The snap ring (3) for detachably 
connecting the bag is preferably disposed parallel to the plane of the 
base plate (1) and is--connected by the connector piece (2)--spaced only 
some mm therefrom. 
The dimension of the aperture of the snap ring is determined by the 
diameter of the said second circumference (14) at the base plate (1). Any 
normal bag having a snap closure can be fastened to the snap ring (3) and 
removed therefrom for replacement. 
In the device of the invention the conventional base plates can be used, 
which consist preferably of a hypoallergic material having a thin elastic 
film on the outside. However, there may also be used as "base plates" 
simple films with the adhesives customary in connection with adhesive 
bags. Since the base plate has to be replaced only at intervals of several 
days, the skin damaging by stripping is minimal also in this simple and 
economic embodiment, in contrast to adhesive bags which have to be 
replaced once or several times a day. 
The manner of connecting the connector piece (2) to the base plate (1) is 
not critical; due to the easy performance, a welding or gluing is 
preferred in practice. The edge (11) between the base plate (1) and the 
connector piece (2) is preferably rounded off so as to keep a soiling by 
excreta as low as possible. For the same purpose the undercut of the 
body-facing snap ring (15) is provided preferably at the outer 
circumference of the ring. 
The invention comprises the following advantages: 
1. The flexible connector piece reduces the discomfort to the patient by 
the rigid closure, especially if it is sufficiently long and thus provides 
sufficient clearance. 
2. The device preserves the base plate, because the snap closure is spaced 
apart from the base plate. It can be worn for a longer period (economic 
advantage) and has to be replaced less frequently (convenience for the 
patient). 
3. The connector piece eliminates soil-catching niches if it seals the 
inner side of the snap ring facing the base plate. This applies 
particularly if the inner diameter (8) of the snap bag fits over the outer 
diameter (7) of the snap ring. 
4. Since the connector piece is connected to the base plate in the outer 
area thereof so as to be more or less coincident with the snap ring, the 
user of the device according to the invention can enlarge the opening for 
the stoma in the base plate within relatively wide limits, in accordance 
with his individual needs. In particular with respect to the large stomata 
the tending of which is most difficult, there is achieved thereby a more 
advantageous ratio between the size of the stoma and that of the ring than 
would be possible with a connection between base plate and connector piece 
situated in the central area of the base plate as it is the case in U.S. 
Pat. No. 4,419,100. 
5. The connection between the snap ring and the snap closure of the bag can 
be effected without any traction force on the skin surrounding the stoma 
which is quite sensitive. In this respect, too, a quite considerable 
advance is achieved in comparison with the known arrangements. 
According to a further improvement, the device of the invention is provided 
with a soil repeller (10). For this purpose the connector piece (2) is 
wholly or partially extended beyond the snap ring (3) (see FIG. 3a), with 
the possibility of being narrowed e.g. to a truncated cone. The snap ring 
then will not be soiled when the bag is being replaced. A further 
improvement in this respect is provided by the feature that the film on 
the base plate as well as the inner side of the movable connector piece is 
siliconized so as to achieve a complete discharge into the bag. The soil 
repeller can also be extended to a nonreturn valve (12); see FIG. 3b. Than 
the sensitive skin in the direct surroundings of the stoma is protected 
primarily at night against a flowing back of the aggressive or infectious 
excreta.