WO1992018074A1

WO1992018074A1 - A device in a stoma bandage, a method in using said device, and a method for producing the device

Info

Publication number: WO1992018074A1
Application number: PCT/SE1992/000250
Authority: WO
Inventors: Jan Clarén
Original assignee: Crafcontrol Ab
Priority date: 1991-04-18
Filing date: 1992-04-15
Publication date: 1992-10-29
Also published as: SE9101160L; AU1678292A; SE9101160D0

Abstract

A device in a stoma bandage comprising a fastening element to be attached to the skin of an ostomy operated person, applied around the stoma with the intestinal orifice thereof, and a bag integral with or attached to said element into which the intestinal orifice opens, comprising a sealing ring filled with a fluid, to be applied around the stoma. The sealing ring is flexibly adjustable and has a variable diameter by the pressure of said fluid being increased or decreased for adjustment to the stoma of a user in order to seal between the stoma and the bandage independently of the diameter of the stoma at different times and under different conditions, as well as a method in using such a sealing device, and a method for producing a sealing device.

Description

A DEVICE IN A STOMA BANDAGE, A METHOD IN USING SAID DEVICE, AND A METHOD FOR PRODUCING THE DEVICE.

Technical field

This invention relates to a device in a stoma bandage for preventing leakage, comprising a fastening element to be attached to the skin of an ostomy operated person applied around the stoma with the intestinal orifice thereof, and a bag integral with or attached to said element into which the intestinal orifice opens, and a sealing ring filled with a fluid to be applied around the stoma, and a method for bandaging an ostomy operated person, the invention also relates to a method for producing a sealing ring for a stoma bandage.

State of the art

After an operation of the gastrointestinal system and/or the urinary tract it may be necessary to provide the patient with an abdominal stoma. One consequence thereof is that the patient will lack the ability to control the evacuation of fecal material, liquid, urine and/or gases. In an operation of this kind a channel is opened through the abdominal wall to the exterior, a stoma, through which the waste material is discharged. Mainly four different types of stoma operations exist; ileostomy, colostomy, transversostomy and urostomy. Ileostomy is accomplished by the lower part of the small intestine being withdrawn 3-4 cm from the abdominal wall. The bowel contents is normally rich in enzymes and is very liquid. It is thus corrosive when contacting the skin and the outside of the intestine. With this type of stoma a careful bandaging without leakage is of outmost importance in order to give the patient a tolerable existence without pain and suffering. When leaking occurs, a very careful cleansing around the stoma and of the skin is required. Due to soreness, irritation and ulcers, this cleansing is very time- consuming and painful . Colostomy usually refers to sigmoidostomy, i.e. a sto y which is built up by the last part of the colon, the sigmoideum. The stoma normally has a length of 1-2 cm. The bowel contents are substantially solid and problems with gases are often encountered. Transversostomy is performed on a transverse colon and is in most cases a stoma which is temporary. The bowel contents are soft, and this type of stoma is exceptionally difficult to bandage.

Urostomy is accomplished by an intestinal segment being shaped into a stoma against the skin. The ureters are connected to this intestinal segment, a stoma. In this case, an extremely careful sealing is required.

In all these stomata it is of great importance for the patient that the bandage can be easily changed and that both the stoma opening and the skin around the stoma can be easily kept clean.

The patients with stomata usually use disposable type bandages. These can be bandages constructed in one piece or bandages constructed in two pieces. Bandages in one piece consist of a fastening device to be attached to the skin, with an accompanying bag. If the bag cannot be emptied the bandage as a whole must be changed every time the bag is full, which can happen several times per 24 hours. This is very trying for the patient and irritating for his skin.

Bandages constructed in two pieces consist of a plate forming an aperture for the stoma, which can be attached to the skin and onto which plate a bag can be attached. The plate can be attached to the person for a period of one week while the bag normally has to be changed several times a day. The plate usually has a material layer closest to the body that is kind to the skin. The material layer has an opening the diameter of which can be varied depending on the thickness of the stoma of different persons. The diameter of the opening is, however, smaller than the diameter of the aperture in the plate in order to increase the sealing between bandage, intestine and underlying skin. However, the material layer has the drawback that it can be affected by the gastric acid and the enzymes in the contents of the intestine, and the material layer can gradually be degraded. During leakage, the diameter of the opening is thus increased and an even bigger leakage arises between stoma, bandage and underlying skin, implying that the plate has to be changed earlier than intended. Each time the patient changes the position or posture of the body the diameter of the intestine may be changed. This can happen, for example, also when exercising different physical activities and is mainly caused by the peristaltic movements of the intestine, during which process the diameter of the intestine is changed, which causes the formation of a space between the intestine and the opening of the bandage. When the diameter of the intestine is changed the risk of leakage with accompanying rebandaging will be increased. Such a bandaging is both time-consuming and physically trying since the user, due to the leakage, has to carefully clean around the stoma.

DE-A1-30 04 796 discloses a stoma bandage of the kind mentioned above comprising a fastening plate having a ring- shaped sealing filled with a fluid. The sealing ring lacks arrangements for adjusting later the sealing ring, when used, to the stoma of a user. When the diameter of the intestine decreases the contact area of the ring against the intestine is also reduced and the sealing becomes insufficient. DE-A1-36 37 355 discloses a sealing device for a stoma constructed as an orifice in the abdominal wall without an intestinal segment being withdrawn through the abdominal wall. A socket is inserted into the orifice in the abdominal wall, which comprises two peripheral flanges and a O-ring. When attaching the device, the distance between the flanges is adjusted by means of the O-ring for application of the socket independently of the thickness of the abdominal wall.

Short description of the concept of invention

The object of the present invention is to eliminate the above-mentioned disadvantages of stoma bandages. A primary object of the invention is to provide a device in a stoma bandage which results in a careful sealing between stoma, bandage and underlying skin.

.Another object of the invention is to provide a device in a stoma bandage which is flexibly variable with respect to the diameter thereof.

Still another object of the invention is to provide a device in a stoma bandage which is easily applyable.

Still another object of the invention is to provide a device the diameter of which can be adjusted easily in order to be adapted to the needs of different persons at different situations and conditions.

A further object of the invention is to provide a device in stoma bandage of the above-mentioned kind which can be used together with stoma bandages available on the market.

A further object of the invention is to provide a device which is kind to the skin and the intestine (stoma) of the user.

A still further object of the invention is to provide a device in a stoma bandage which is both cheap and easy to manufacture. These and other objects are obtained according to the invention in a device initially referred to, in that the diameter of the sealing ring can be varied by increasing or decreasing the pressure of said fluid for flexible adaptation to the stoma (intestine) of a user so as to seal between the stoma (intestine) and the bandage independently of the diameter of the stoma (intestine) at different times and under different conditions.

The invention will now be described with reference to the accompanying drawings, in which

FIG 1 shows an embodiment of bandaging by means of the device according to the invention which is disclosed in elevational and partly cross sectional view,

FIG 2 shows an elevational view of a bandaging device according to FIG 1, which is applied to the skin of the user,

FIG 3 shows another embodiment of bandaging which is accomplished by means of the device according to the invention and is disclosed in elevational and partly cross sectional view,

FIG 4 shows the bandaging according to FIG 3 which is applied to the skin of a person, disclosed in elevational and partly cross sectional view,

FIG 5 shows a further embodiment of the inventive device to be mounted in a bandaging device already available on the market, as seen in front view, not yet finally mounted,

FIG 6 shows the embodiment disclosed in FIG 5 as seen in plan view, FIG 7 shows the embodiment disclosed in FIG 5 in cross section along a line A-A in FIG 5,

FIG 8 shows the embodiment disclosed in FIGS 5, 6 and 7 with the flexible sealing material, the membrane, as mounted. Detailed description of a preferred ^p>τnhf.fl-iment of the invention

FIGS 1 and 2 show how a sealing ring 3 has been applied to a stoma (intestine) 1. In this connection, the inner pressure of the ring has been adjusted by the supply of fluid through the wall of the sealing ring 3 in order that the inner pressure of the sealing ring 3 will be adapted to the stoma 1 and the sealing ring 3 will be applied relatively tightly to the stoma 1. Then a fastening element 4 forming an aperture is slipped over the stoma and the sealing ring which then are attached to the skin 2 of the user by means of an adhesive provided on one side 5. For that reason, the flexible sealing ring 3 will be flattened since the aperture in the fastening element 4 has a diameter which is smaller than the outer diameter of the sealing ring 3. The sealing ring 3 thus obtains a larger contact area against the intestine 1 and will tightly contact the same. Then the bag 7 is attached to the fastening element 4 by means of an adhesive or fastening means provided on the outer side 6 of the fastening element or on the bag 7 around the opening.

FIGS 3 and 4 show another embodiment of the invention comprising a bandage in one piece. The sealing ring 3 has been applied on that side of the fastening element 4 which faces towards the skin in the position of use. In this embodiment the whole bandage is applied in one step, the inner pressure of the sealing ring 3 being adjusted before bandaging. The sealing ring 3 is threaded onto the stoma, whereupon the rest of the bandage with its fastening element 4 and bag 7 is pressed against the skin 2 around the stoma and is attached. As the openings in the fastening element 4 and the bag 7, through which the stoma opens, are smaller than the outer diameter of the sealing ring 3, the sealing ring will be turned into the bag 7 and close tightly against the outer wall of the stoma due to the flexibility and elasticity of the sealing ring 3, as illustrated in FIG 4.

FIGS 5-8 show a further embodiment of the inventive device to be applied to bandaging devices already available on the market, of that kind which comprises a stiff holding ring for the attachment of a bag 7 on a fastening element 4.

This device comprises a stiff ring 9 with grooves provided around its outer periphery for connection to a holding ring for the bag in a stoma bandage available on the market and comprising two pieces. A thin, flexible, elastic annular sealing material, a membrane 12, is sealingly attached, integrally with said ring, to one edge of the inner periphery of the ring 9 at one of its free edges. At the other free edge of the material an O-ring 13 is provided and is integrated with the material. In that way this material 12 can constitute a part of an inflatable sealing ring 3 after the material with the O-ring has been turned into the ring 9 and the O-ring has been f stened in a groove 17 provided for this purpose, and has been fluidtightly sealed. A passage 14 is provided in the inner evelope surface of the ring, which is connected with the outer envelope surface via a non-return valve or the like for the supply and removal of fluid in the sealing ring. It is most evident from FIGS 7 and 8 how this embodiment is intended to be manufactured.

The material of the sealing ring can be of synthetic or natural material. Furthermore, the sealing ring can be made of foamed plastic or foamed polyurethane with 100 % closed cells at least on one side.

A device such as a helical spring or a similar device can be introduced into the interior of the ring in order to increase the contact against the intestine and the bandage. The supply and removal of fluid can take place via a valve or via an injection needle inserted directly into the sealing ring which in this latter case is manufactured of a material which works as a septum and into which a needle can be inserted several times without the risk of leakage. The ring is inflated to a volume which is suitable for the individual patient, for example by means of a graded syringe. When fluid is to be removed a suitable amount is withdrawn from the sealing ring by means of a syringe. The fluid can be air, oil, silicon, a gel or the like.

Furthermore, the sealing ring can be furnished with small cushions with fluid which easily can be supplied to the sealing ring for example via a passage with a non¬ return valve by the cushions being subjected to pressure.

Of course, the invention is not limited to the illustrative embodiments shown in the accompanying drawings and described in connection therewith. On the contrary, modifications may be envisaged within the scope of the following claims.

Claims

1. Device in stoma bandage comprising a fastening element (4) to be attached to the skin (2) of a ostomy operated person, applied around the stoma with the intestinal orifice thereof, and a bag (7) integral with or attached to said element into which the intestinal orifice (1) opens, comprising a sealing ring (3) filled with a fluid, to be applied around the stoma (intestine) (1), c h a r a c t e r i z e d in that the sealing ring (3) is flexibly adjustable and has a variable diameter by the pressure of said fluid being increased or decreased for adjustment to the stoma (intestine) (1) of a user in order to seal between the stoma (intestine) (1) and the bandage (4, 7) independently of the diameter of the stoma

(intestine) (1) at different times and under different conditions.

2. Device as in claim 1, c h a r a c t e r i z e d in that the sealing ring (3) is made of a material, e.g. latex, which can function as a septum through which an injection needle can be inserted in order to supply or remove fluid.

3. Device as in claim 1, c h a r a c t e r i z e d in that a tubing is provided in the material surface of the sealing ring (3) for the supply and removal, respecively, of fluid to and from the interior of the sealing ring via a valve.

4. Device as in claim 1, c h a r a c t e r i z e d in that the fastening element (4) has an adhesive on one side for attachement of the fastening element to the skin.

5. Device as in claim 1, c h a r a c t e r i z e d in that the fastening element (4) has an adhesive on both sides for attachement of the fastening element (4) to the skin and for attachement of a bag (7) to the fastening element ( ) .

6. Device as in claim 4, c h a r a c t e r i z e d in that the sealing ring (3) is provided on that side of the fastening plate (4) which is facing towards the skin of the user just before application to that person.

7. Device as in claim 1, c h a r a c t e r i z e d in that an aperture is provided in the fastening plate (4), the diameter (d) of which is smaller than the outer diameter of the sealing ring.

8. Device as in cla 7, c h a r a c t e r i z e d in that the fastening plate and the bag (7) are integral.

9. Device as in claim 7, c h a r a c t e r i z e d in that the bag (7) is attached to that side of the fastening plate (4) which is facing from the skin of the user at the time of application.

10. Device as in claim 1, c h a r a c t e r i z e d in that the sealing ring (3) in the side facing towards the stoma (1) comprises a thin, flexible material, a membrane, and that the remaining part of the sealing ring comprises a thicker ring material.

11. Device as in claim 10, c h a r a c t e r i z e d in that one edge of the thin material is integrated with the thicker material and that an O-ring is integral with the material at the other free edge thereof.

12. Device as in claim 11, c h a r a c t e r i z e d in that a groove (17) is provided on the thicker part of the sealing ring for receiving the O-ring (13) at the side opposite to that side where the thinner material is attached to the thicker ring material.

13. Device as in claim 10, c h a r a c t e r i z e d in that a passage (14) is provided in the thicker material for supplying fluid to that part of the sealing ring which, in the position of use, faces towards the stoma, one half thereof being delimited by the membrane (12) .

14. Device as in claim 10, c h a r a c t e r i z e d in that a seling device (11) is provided on the outer periphery of the thicker surface of the ring for sealing against an inner surface of a supporting ring for a bag in a conventional bandage.

15. Method of bandaging an ostomy operated person by using a device according to claim 1, whereby an intestinal section with an opening, a so called stoma, has been withdrawn through the abdominal wall and, upon bandaging, a flexible, elastic sealing ring filled with a fluid is passed onto the stoma, c h a r a c t e r i z e d in that the diameter of the sealing ring (3) in a first step is adapted to the diameter of the stoma by increasing or decreasing the pressure of the fluid, whereupon an element (4) to be attachable to the skin (2) for supporting a bag is slipped around the stoma (1) and is applied against the skin (2) of the user.

16. Method as in claim 15, c h a r a c t e r i z e d in that the inner diameter of the sealing ring (3) is substantially adapted to the outer diameter of the stoma by supplying fluid, and that said sealing ring together with a fastening plate (4) is then placed on the skin of the user. after which, when the bandage comprises two pieces, the bag (7) is applied.

17. Method for producing a sealing ring as claimed in claims 10-14, c h a r a c t e r i z e d in that the thicker part of the sealing ring with passage, groove and with valve, if any, and the thinner part with O-ring are manufactured by compression moulding, die casting or the like in one step.

AMENDED CLAIMS

[received by the International Bureau on 22 September 1992 (22.09.92); original claims 1-17 replaced by amended claims 1-10 (2 pages)]

1. Stoma bandage comprising a fastening element (4) and a bag (7) integral with or attached to said element, to be attached onto the skin (2) of an ostomy operated person around the stoma with the intestinal orif ce thereof opening into said bag, and further comprising a sealing ring (3) filled with a fluid, to be applied around the stoma, said sealing ring (3) being flexibly adjustable and the diameter thereof being variable for adjustment to the stoma by the pressure of said fluid being increased or decreased, c h a r a c t e r i z e d in that the sealing ring (3) is intended for application around that part of the stoma (1) which is located outside the epidermis, to seal the bandage against the stoma and independently of the diameter of the stoma, at different times and under different conditions.

2. Stoma bandage as in claim 1, c h a r a c ¬ t e r i z e d in that the fastening element (4) comprises a flat thin flexible plate forming an aperture, and em adhesive on one side of said plate for attaching the plate to the skin.

3. Stoma bandage as in claim 1, c h a r a c ¬ t e r i z e d in that the sealing ring (3) is made of a material, e.g. latex, functioning as a septum through which an injection needle can be inserted in order to supply or remove fluid, respectively.

4. Stoma bandage as in claim 1, c h a r a c ¬ t e r i z e d in that the sealing ring (3) has a tubing for the supply and removal, respectively, of fluid to and from, respectively, the interior of the sealing ring via a valve.

5. Stoma bandage as in claim 1, c h a r a c ¬ t e r i z e d in that the fastening element (4) has an adhesive on both sides thereof for the attachement of the fastening element (4) to the skin and for the attachement of the bag (7) to the fastening element (4) .

6. Stoma bandage as in claim 1 or 2, c h a r a c ¬ t e r i z e d in that the sealing ring (3) is located on that side of the fastening element (4) which is intended to face the skin of the user.

7. Stoma bandage as in claim 1 or 2, c h a r a c ¬ t e r i z e d in that the bag (7) is located on that side of the fastening element (4) which is intended to face away from the skin of the user.

8. Stoma bandage as in claim 2, c h a r a c - t e r i z e d in that said aperture in the f stening plate (4), has a diameter (d), which is smaller than the outer diameter of the sealing ring. 9. Method of bandaging an ostomy operated person by using a device according to claim 1, whereby an intestinal section with an opening, a so called stoma, has been withdrawn through the abdominal wall and, upon bandaging, a flexible, elastic sealing ring filled with a fluid is passed onto the stoma, c h a r a c t e r i z e d in that the diameter of the sealing ring (3) in a first step is adapted to the iameter of the stoma by increasing or decreasing the pressure of the fluid, whereupon an element (4) to be attached to the skin (2) for supporting a bag is slipped around the stoma (1) and is applied against the skin (2) of the user.

10. Method as in claim 9, c h a r a c t e r i z e d in that the inner diameter of the sealing ring (3) is substantially adapted to the outer diameter of the stoma by supplying fluid, and that said sealing ring together with a fastening plate (4) is then placed on the skin of the user, after which, when the bandage comprises two pieces, the bag (7) is applied.