EP1005298A1

EP1005298A1 - Ostomy device

Info

Publication number: EP1005298A1
Application number: EP98901329A
Authority: EP
Inventors: Daniel Bar-Shalom
Original assignee: Individual
Current assignee: Individual
Priority date: 1997-02-06
Filing date: 1998-02-06
Publication date: 2000-06-07
Also published as: WO1998034573A1; AU5749698A

Abstract

An ostomy device comprising an ostomy bag, the ostomy bag being adpated to be attached to the body of a user by means of at least two pads directly and/or indirectly attached to the bag, the at least two pads comprising a first pad surrounding the ostomy opening and a second pad distinct from the first pad. The second pad is typically larger than the first pad and provides a support function, thereby reducing the risk of detachment of the bag. The device may also comprise additional attachment pads distinct from the first and second pads.

Description

OSTOMY DEVICE

FIELD OF THE INVENTION

The present invention relates to an ostomy device with improved attachment of a body waste collecting bag (colostomy, ileostomy, urostomy, wound drainage, etc.) to the body using two or more attachment pads.

BACKGROUND OF THE INVENTION

Body waste collecting bags (colostomies , ileostomies, urostomies, wound drainage devices, etc.), in the following collectively referred to as "ostomy bags", are attached to the body of the user by means of a pad around the ostomy opening, typically by attaching the pad to a plate which is attached to the body by means of an adhesive, the pad typically being attached to the plate by means of an adhesive. The pad is in turn typically either attached directly to the ostomy bag by welding thereto or by means of an adhesive or indirectly attached to the ostomy bag by means of a ring, typically welded to the bag, the ring being fitted onto a flange on the pad. The adhesive which holds the plate in contact with the body functions 1) to hold the plate, and thus the ostomy bag, in place, and 2) to prevent the waste being collected from going anywhere but into the bag. The body wastes collected in the bags contain varying amounts of water (urine more than ileal lumen more than colon lumen; diarrhoeal colon lumen more than "normal" lumen; etc.) .

The water in the waste results in certain problems in ostomy devices according to the prior art. One problem is that the water interacts with the adhesive of the plate at the ostomy opening, often resulting in a reduction of the adhesiveness between the plate and the body and/or reduction of adhesiveness between the plate and the pad. Another problem is that accumulating body waste in the bag exerts weight. The combination of these two factors, i.e. loss of adhesiveness together with the weight of the bag containing waste, may result in detachment of the bag with considerable discomfort and embarrassment to the user.

An object of the present invention is therefore to provide an ostomy device which does not suffer from the above-mentioned disadvantage, so that detachment resulting from the combination of loss of adhesiveness and the weight of the body wastes in the ostomy bag is prevented. A further object of the invention is to provide an ostomy device which is more comfortable and convenient for the user. These objects are achieved according to the invention by providing an ostomy device with an ostomy bag which is attached to the body of the user by means of at least one pad around the ostomy opening and at least one pad located elsewhere on the bag but not in direct contact with the pad around the ostomy opening.

BRIEF DISCLOSURE OF THE INVENTION

The present invention relates to an ostomy device comprising an ostomy bag, the ostomy bag being adapted to be attached to the body of a user by means of at least two pads directly and/or indirectly attached to the bag, the at least two pads comprising a first pad surrounding the ostomy opening and a second pad distinct from the first pad.

DETAILED DESCRIPTION OF THE INVENTION

The ostomy bag of the invention is adapted to be attached directly and/or indirectly to the body of the user by means of the at least two pads attached to the bag. A pad which is "directly" attached to the body of the user will typically be attached thereto by means of an adhesive, e.g. an adhesive layer applied to the body-facing pad surface. The adhesive may in this case also e.g. be a double-sided tape applied to the body- facing pad surface, the double- sided tape typically being attached to the pad surface during the manufacture of the bag. The adhesive, whether directly applied to the pad in the form of an adhesive layer or e.g. in the form of a double-sided tape, will typically have its body-facing surface protected by a removable liner, e.g. a releasable paper or plastic liner which is removed by the user immediately before attachment of the ostomy bag to the body.

When the ostomy pad is attached "indirectly" to the body of the user, this refers to the fact that the ostomy bag is attached via a plate or wafer, which in turn is directly attached to the body of the user. The "plate" is typically made of a plastic material which is attached to the body using an adhesive. Examples of plastic materials which are suitable for use as a plate are polyolefins, e.g. polyethylene or polypropylene, polyester, polyurethane, rayon, EVA (ethylene-vinyl acetate copolymer) , etc. A preferred material for the plate is polyethylene.

The attachment of the pads of the ostomy bag to the plate may be accomplished in a number of ways. Typically this will be by means of an adhesive and/or another mechanical connection mechanism. An example of a mechanical connection mechanism which is well-suited for use in the present invention is a refastenable closure system, such as Velcro or product Nos . 9921 or 9920 available from the Minnesota Mining and Manufacturing Co. When an adhesive, e.g. a refastenable adhesive, is used, it may be directly applied to the plate and/or pad, or it may e.g. be in the form of a double- sided tape, for example a double-coated medical tape such as product No. 9877 available from the Minnesota Mining and Manufacturing Co.

The attachment of the first and second pads to the ostomy bag may similarly be accomplished in a number of ways. The pads will often be directly attached to the bag, e.g. welded to the bag or attached to the bag by means of an adhesive, the adhesive in this case generally being of a non-releasable type. Alternatively, the pad may be indirectly attached to the bag, e.g. by means of the pad being fitted with a flange adapted to receive a ring which is directly attached to the bag, e.g. welded to the bag. As the pad is typically made from a thin sheet of plastic material, it may suitably be welded to the bag when the plastic of the pad is of a type which is compatible for welding to the plastic of the bag. This also applies to a plastic ring welded to the bag in the case of a ring adapted to be attached to a flange on the pad. The bags themselves are typically made of a material such as polyethylene, polyurethane, EVA, etc. In general, the bags, plates and pads of the ostomy device of the present invention may be prepared from materials which are already known and used in the art for the production of ostomy devices .

As mentioned above, the ostomy bag of the present invention is held in place on the body of the user by means of at least two distinct and unconnected pads. One of the pads (referred to herein as "the first pad") surrounds the ostomy opening, thereby serving to seal the passage from the ostomy to the bag and ensure that waste from the body is discharged into the bag and does not leak onto the user or the clothes of the user. The other pad (referred to herein as "the second pad") is located at another position on the bag separate from the first pad and provides a separate support function. In contrast to the ostomy devices of the prior art, in which the support function is exclusively provided by a single pad surrounding the ostomy opening, in the ostomy device of the present invention the weight of the ostomy bag and its contents is primarily supported by the second pad. This means that the first pad, while of course still providing a certain support function, is relieved of tension that would otherwise be caused by the weight of the bag and its contents . As a result, the attachment of the bag to the body of the user around the ostomy opening (whether this attachment is direct or indirect) is greatly improved. Thus, an improved seal around the ostomy opening and a greatly reduced risk of detachment of the bag is obtained.

The pads of the ostomy device of the invention are typically produced from thin sheets of a plastic material such as those mentioned above as possible plate material, i.e. polyethylene, polypropylene or another polyolefin, polyester, polyurethane, rayon, EVA, etc. The pad may alternatively be in the form of a single-coated tape or double-coated tape, e.g. a plastic medical tape. When the pad is formed from a plastic material or a single-coated tape, the body facing side of the pad will typically be coated with a layer of an adhesive suitable for attaching the pad, and thus the ostomy bag, to the body of the user or to a plate attached to the body of the user.

An example of a suitable pad is e.g. a sheet of polyethylene coated with pressure sensitive acrylate. An example of a suitable hydrophilic adhesive coating is a mixture of 40% polyisobutylene, 20% CMC (carboxymethylcellulose) , 20% gelatine and 20% pectin. An example of a suitable hydrophobic coating is 10% polyester (e.g. Kraton G 1650, a stearin- ethylene-butadiene copolymer, available from Shell), 69.9% of a cycloaliphatic resin (e.g. Regalite R91) , 20.3% paraffin oil and 0.1% of an antioxidant .

The first and second pads may comprise the same material, or the first pad may comprise a different material than the second pad. When the first and/or second pads comprise and adhesive on the body-facing surface thereof, the adhesive may be of a hydrophilic material or a hydrophobic material. If appropriate, one of the pads, typically the first pad, may comprise a hydrophobic adhesive, and the other pad, typically the second pad, may comprise a hydrophilic adhesive.

It is preferable that the first pad surrounding the ostomy is just big enough to ensure a good seal around the opening, as little or no physical force is exerted on the first pad. It is also generally preferable that the first pad is made of a hydrophobic material so as to eliminate interactions between the body waste liquid and the material of the first pad. On the other hand, it will often be preferable that the second pad, which will generally be larger than the first pad, is made of a hydrophilic or hydrocolloid material, since such materials are often more skin friendly than hydrophobic materials .

The geometric arrangement of the first and second pads may vary. Since the first pad surrounds the generally round ostomy opening, the first pad will often have a more or less circular or rounded shape, although the precise shape of the pad is not critical. The first pad may thus also be shaped e.g. as an oval or ellipse or may be angular, e.g. an essentially square, rectangular, triangular or diamond shape, typically with rounded angles .

The second pad may, for example, have one of the shapes mentioned above for the first pad, but it may also have a number of other shapes, including oblong shapes, and the precise shape of the second pad is also not critical . The second pad may in some embodiments surround or partially surround the first pad, in which case the second pad may e.g. be in the form of a ring or may have a semi-circular, horseshoe or U-shape. In use, the second pad will often be located below the first pad, but this is not necessarily the case. Thus, the second pad may be adapted to be located above the first pad when in use, or, as explained above, it may surround or partially surround the first pad.

Since, as explained above, the first pad of the ostomy device of the present invention does not have to provide any substantial support function, the first pad will typically be relatively small compared to the pads used for attaching prior art ostomy devices . The second pad will therefore typically have a surface area which is larger than the surface area of the first pad.

Of course, the device may also optionally contain more than two pads, in which case the first pad will be essentially as described above for the first pad, while the second, third and any other additional pads will be essentially as described above for the second pad. The ostomy device of the invention may thus e.g. comprise distinct second and third pads, in which the second and third pads may be arranged in numerous configurations with respect to each other and with respect to the first pad, for example as two oblong pads arranged parallel to each other either vertically or horizontally below the first pad, as a second pad surrounding the first pad and a third pad located below the second pad, etc. It should be noted that, for the sake of simplicity, the invention is described herein primarily with reference to first and second pads only, but it will be clear for persons skilled in the art that the principle of the invention is equally applicable to embodiments with more than two pads.

As explained above, one or both of the first and second pads may be indirectly attached to the body of the user via a plate attached to the user. When both the first and second pads are indirectly attached in this manner, they may be attached to a single plate or to separate first and second plates, respectively.

When one of the first and second pads is directly attached to the body of the user and the other of the first and second pads is indirectly attached to the user via a plate attached to the body of the user, it will typically be the first pad surrounding the ostomy opening which is indirectly attached and the second pad which is directly attached.

DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a view of the body-facing surface of a conventional ostomy bag according to the prior art with a gas filter and a single, relatively large attachment pad (e.g. adhesive pad) around the ostomy opening.

Fig. 2 shows a view of the body facing surface of an ostomy bag according to the present invention. In contrast to the prior art ostomy bag shown in Fig. 1, the ostomy bag shown in Fig. 2 has a relatively small attachment pad (e.g. adhesive pad) surrounding the ostomy opening and a large second attachment pad (e.g. adhesive pad) distinct from the pad around the opening.

Fig. 3 shows a sectional side view of a prior art ostomy bag similar to that shown in Fig. 1. In this case, the ostomy bag 2 is attached to a pad 4 having a flange 6 by means of a ring 8 attached, e.g. welded, to the bag 2. The pad 4 is attached to a plate 10 which is attached, e.g. using an adhesive, to the body of the user. The ostomy bag 2 has an opening 12 to the intestine 14.

Fig. 4 shows a sectional side view of an ostomy bag according to the present invention similar to that shown in Fig. 2. The attachment of the bag 2 around the ostomy opening 12 is as shown in fig. 3, i.e. by means of a ring 8 attached to the bag 2 and fitted to the flange 6 of the pad 4, the pad 4 being attached to the plate 10. The bag 2 further comprises a second pad 16 attached thereto. The second pad 16 is in this case attached, e.g. using an adhesive or a refastenable closure system, to a second plate 18 attached to the body of the user.

Figures 5-12 show views of the body facing surface of examples of various embodiments of the ostomy bag of the invention. In each case, the ostomy bag comprises a gas filter, a first attachment pad (adhesive pad) surrounding the ostomy opening, and one or more additional attachment pads (adhesive pads) distinct from the first attachment pad. (Note: Although all of the figures 1-2 and 5-12 show a gas filter, this is only for the purpose of indicating the approximate position of the gas filter in relation to the ostomy opening. In practice, the gas filter will normally be on the opposite side of the bag, i.e. the side facing away from the body of the user) .

Claims

1. An ostomy device comprising an ostomy bag, the ostomy bag being adapted to be attached to the body of a user by means of at least two pads directly and/or indirectly attached to the bag, the at least two pads comprising a first pad surrounding the ostomy opening and a second pad distinct from the first pad.

2. An ostomy device according to claim 1 wherein the first and second pads are adapted to directly attach to the body of the user.

3. An ostomy device according to claim 1 wherein the first and second pads are adapted to attach to a single plate attached to the body of the user or to separate first and second plates attached to the body of the user.

4. An ostomy device according to claim 1 wherein one of the first and second pads is adapted to be directly attached to the body of the user and the other of the first and second pads is adapted to be indirectly attached via a plate attached to the body of the user.

5. An ostomy device according to claim 3 or 4 wherein the first pad is adapted to be indirectly attached to the body of the user, via a plate, by means of an adhesive or a mechanical connection mechanism, e.g. a refastenable closure system.

6. An ostomy device according to any of claims 1, 3 or 4 wherein the second pad is indirectly attached to the body of the user by means of an adhesive or a refastenable closure system.

7. An ostomy device according to any of claims 1-6, where the first and second pads comprise the same material .

8. An ostomy device according to any of claims 1-6 wherein the first pad comprises a different material than the second pad.

9. An ostomy device according to claim 7, wherein the first and second pads comprise a hydrophilic material.

10. An ostomy device according to claim 7, wherein the first and second pads comprise a hydrophobic material .

11. An ostomy device according to claim 8 wherein the first pad comprises a hydrophobic material and the second pad comprises a hydrophilic material.

12. An ostomy device according to any of claims 1-11 wherein the second pad is in the form of a ring or has a semicircular, horseshoe or U-shape and is arranged around the first pad.

13. An ostomy device according to any of claims 1-11 wherein the second pad is directly or indirectly attached to a portion of the bag which is adapted to be arranged above or below the ostomy opening.

14. An ostomy device according to any of claims 1-13 wherein the second pad has a surface area which is larger than the surface area of the first pad.

15. An ostomy device according to any of claims 1-14 wherein the first and second pads are welded to the bag and/or are attached to the bag by means of an adhesive.

16. An ostomy device according to any of claims 1-14 wherein the first pad is adapted to indirectly attach to the bag by means of a flange .

17. An ostomy device according to any of claims 1-16 which comprises at least one additional pad distinct from the first and second pads .