WO1985000286A1

WO1985000286A1 - Stoma bag

Info

Publication number: WO1985000286A1
Application number: PCT/FI1984/000048
Authority: WO
Inventors: Juha Henttonen; Juhani Ikonen
Original assignee: Hantaaki Oy
Priority date: 1983-06-30
Filing date: 1984-06-29
Publication date: 1985-01-31
Also published as: IT8448481A0; FI67297C; SE8500555L; FI832395A0; DK91385D0; GB2142543A; ES8600922A1; DE3490331T1; SE8500555D0; GB8416553D0; ES533841A0; BE900059A; AU3005784A; FI67297B; IT1177856B; GB2142543B; DK91385A; FR2548014A1

Abstract

A bag supportable upon a person for receiving discharges from a stoma and having a hollow interior (11) defined by inner (10, 14) and outer (12) opposing walls connected along their edges. The inner wall has an inlet opening (57) for receiving the stoma and an extension of this wall (10) and/or a layer of adhesive tape (45) around the inlet opening is compressively clamped between clamping surfaces of inner (33) and outer (31) snap rings of a bag supporting carrying ring (30). Positive interference between interlocked engaging means on the clamping surfaces prevents removal of the inner ring from its clamping position within the outer ring unless the interlocking relationship is broken by distortion of the rings. The carrying ring (30) also may carry a belt (70) for engaging body surfaces to hold the bag in position relative to the stoma. A comfort layer (14) of porous material also may be provided as a part of the inner wall (10) and covering for the external surface of the inner bag wall (10) resting against the body. The adhesive layer (45) and/or the comfort layer (14) may be clamped between the inner (33) and outer (31) snap rings along with the inner bag wall extension. The carrying ring may support a gasket (54) of moisture absorbing gum for sealingly engaging a surface of the body adjacent to the stoma.

Description

STOMA BAG

The present invention relates generally to a stoma bag more closely defined in the preamble of the claim 1. The stoma bag is positioned next to a surgical opening in the human body to receive and hold a discharge from that opening. More particularly, the invention relates to bags for collecting digestive track discharges from an opening in the abdomen wall known as a "stoma".

It sometimes becomes necessary for medical reasons to surgically form an opening in a person's abdomen and to collect discharges from that surgical opening for indefinite periods of time. One such operation is where a patient's intestine is caused to extend through the abdominal wall. Where the large intestine extends through the abdominal wall, the operation is called a colostomy. Where the small intestine extends through the abdominal wall, the operation is called an ileostomy. These operations require the maintenance of an opening in the patient's anatomy for indefinite periods of time. Another operation that sometimes requires the maintenance of an opening for a relatively short time is an appendectomy after an appendix has burst as this may require drainage of undesirable wastes released into the abdominal cavity. All of these surgical procedures require a pouch, bag or other container to receive and hold the discharges from the corresponding surgical openings.

, OMPΓ A wide variety of bag constructions have been used for the collection of waste from stomas and other openings in the body. Some of these bags have two opposing walls of thin-film, flexible plastic material joined together along their edges. These bags generally have an oval or rectangular upper section and a downwardly tapering lower section, leading to a truncated outlet opening. The inner wall of the bag has an inlet opening for receiving the stoma which generally protrudes outwardly from the abdominal wall and into the interior cavity of the bag.

Associated with the inlet opening are often elements for holding the bag in position around the stoma and for sealing the inlet opening to the stoma in an effort to prevent the escape of unpleasant odors from the bag interior. One way of supporting the bag in position is to mount it on a ring which in turn is supported by a belt or belts extending around the waist and/or hips of the person wearing the bag. One such construction for supporting a thin disposable bag by placing material around the inlet opening of the bag between a pair of rings is illustrated in U.S. Patent No. 2,684,675 of July 27, 1954. More closely this patent relates to a stoma receiver for converting a thin disposable bag into a colostomy appliance. However, this arrangement has a number of disadvantages. For example, the thin plastic sheet material is uncomfortable where it rests against body surfaces and can stick and cause excessive perspiration. In an effort to alleviate this problem, this patent suggests the use of a separate body

OMPI engaging absorbent pad but this pad can also absorb waste fluids from the stoma and may quickly develop an unpleasant odor. Another problem with this prior art construction is that the bag material is only loosely held between the two rings and can be pulled away from these rings relatively easily which may result in an embarrassing mess since waste thereby may be prematurely discharged into the clothing of the wearer. The efficiency of this arrangement is totally dependent on the user's skills to assemble and use the arrangement.

It has also been proposed to affix the bag directly to the body with an adhesive tape component or the like which is secured to the bag either by welding or by gluing with an adhesive. This solution has also proven deficient in that the material of the adhesive tape is not easily joined to the material of the bag so that such a joining is very difficult and may result in a joint that is weak and comes apart during use. While it has also been proposed to attach the inner wall of the bag to a carrying ring by an adhesive or the like, it is difficult to obtain a secure connection between the material of the bag wall and the plastic^'material from which carrying rings may be made.

Another disadvantage of the prior art is that there is no airtight seal around the stoma between a supporting ring and the body. In an effort to make colostomy bags more tight around the stoma, there has been employed an inner ring or gasket of karaya gum such as illustrated in U.S. Patent No. 4,387,713 of June 17, 1983- This sealing material is also difficult to join either directly to a wall of the bag or to a supporting ring.

Many of the foregoing problems and disadvantages of the prior art are overcome by the present invention the scope of which is defined in the characteristics of the enclosed claijns. While the invention employs some of the above-mentioned features, such as a supporting ring, adhesive tape, and karaya rubber, these features are combined with each other and with additional features in a novel and unobvious way so as to provide a more effective and economical stoma bag.

The stoma bag of the present invention has a carrying ring that is made of two concentric snap rings, one having a clamping position within an aperture in the other. Between the two snap rings is a snap joint by means of which an extension of the inner wall of the bag and/or a layer of adhesive material may be secured between the two rings. The extension of the inner wall may comprise a part of the layer of material for body comfort. The bag with the two concentric snap rings forms a disposable assembly, which is replaceable as a whole after intervals depending on the user's needs.

A number of benefits are gained by the snap locking structure that is preferably employed for the joint between the inner and outer snap rings of the bag supporting carrying ring. This snap locking structure comprises an interference fit between interlocking engaging members on the inner surface of the aperture through the outer snap ring and on an outer edge surface of the inner snap ring. The engaging members preferably comprise a ridge and groove on each surface with the shape and size of the ridge on one surface corresponding to the shape and size of the groove on the other surface and these two elements being in opposing relation when the inner ring is interlocked within the outer ring. Materials which do not usually adhere well together are tightly joined to each other in a secure, sealing manner by this snap locking structure. Thus, the thin plastic wall of the bag is joined very tightly to the carrying ring in an effective and economical way suitable for mass production.

The snap locking carrying ring also provides a strong base for supporting a sealing gasket and fasteners for a ^Qag supporting belt. The sealing gasket is preferably made of karaya gum (also known as sterculia gum) or tragacanth gum. A characteristic of these gums is that they absorbe moisture and thereby become viscous and sticky when subjected to body fluids such as digestive fluids and/or perspiration. In addition to the sealing gasket, sealing action also may be provided by a pressure sensitive adhesive layer for adhesion to abdominal skin around the stoma. This adhesive layer also supports the bag in position on the body and in some instances may alone provide sufficient support such that the need for a belt around the body is eliminated.

OMPI While only the inner wall of the bag may be held between the inner and outer snap rings of the carrying ring, the joint between these parts preferably serves as a fixing base for both the 5 adhesive layer and the comfort layer. The adhesive layer is preferably of a porous woven or non—woven fibrous sheet impregnated with a pressure sensitive adhesive composition. The comfort layer is preferably of a woven or non-woven fibrous material that is

^0 sufficiently porous to readily dissipate perspiration from abutting skin surfaces. The joint thus formed between these three layers is very strong and 'especially reliable and provides a gas tight joint between the inner snap ring and the inner bag wall

^5 which helps to prevent the escape of unpleasant odors from the interior of the bag.

A number of variations are possible from the basic structure where all three layers are tightly held between the inner and outer snap rings of the

20 carrying ring. For example, the comfort layer forming a part of the inner wall may be omitted. Alternately, the adhesive layer may be secured to an inner surface of the carrying ring and the comfort layer secured to an outer surface of the carrying ring by welding or

25 an adhesive, with only the inner wall of the bag clamped between the two snap rings. Other alternatives include having the inner wall of the bag adheringly secured to an outer surface of the inner snap ring with the adhesive layer and the comfort

30 layer secured between the snap rings. Instead, the adhesive layer or the comfort layer may be secured to a surface of the outer snap ring with the other layer

OMPI secured in the joint between the two snap rings and the inner wall of the bag adheringly secured to an outer surface of the inner snap ring. When an integral portion of the inner wall of the bag is not clamped between the two snap rings, the inner wall preferably is also attached by welding or an adhesive to one of the other layers so that a portion of the other layer forms an extension of the inner bag wall that is clamped between the two snap rings. The area of this adhesion between the inner wall and another layer is preferably adjacent to the snap joint. Other variations are possible and are contemplated within the scope of the claims below.

Other features of the stoma bag include a peelable protective covering for the sealing gasket, a peelable protective covering for the inner surface of the adhesive layer, a quick fastening and releasing connection between the carrying ring and a supporting belt, and a snap clip for securely sealing the truncated outlet opening of the bag.

The present invention may be understood further from the description below and the accompanying drawings in which:

Fig. 1 is a perspective view of the invention showing protective coverings and different layers peeled partially away from an underlying component.

Fig. 2 is an elevational view in cross-section taken along lines 2-2 of Fig. 1 and showing the bag in its position of use. Fig. 3 is an exploded fragmentary view of one-half of the carrying ring structure and associated layers and components in section taken along lines 4-4 of Fig. 1.

Fig. 4 is a sectional view similar to Fig. 3 but with the carrying ring and associated layers and components in their assembled positions.

Fig. 5 is a view similar to Fig. 4 showing a modification of the invention.

Fig. 6 is a view similar to Fig. 4 showing another modification of the invention.

Fig. 7 is a view similar to Fig. 4 showing a further modification of the invention.

Fig. 8 is a view similar to Fig. 4 showing yet another modification of the invention.

Referring to Figs. 1 and 2, the stoma bag 9 according to the present invention comprises an inner wall 10 and an outer wall 12. A porous layer 14 abuts the exterior surface of inner wall 10 so as to form a comfortable covering for contacting the skin of body 13 against which the stoma bag rests during use. As shown in Figs. 1 and 2, the walls 10 and 12 and the layer 14 are integrally joined together, preferably

O by heat welding, by a seam 15 of adhesion extending along the top and side edges of the bag 9. The bag walls 10 and 12 as integrally joined together by seam 15 define a hollow bag interior 11.

The bag walls of the invention are preferably made from extruded tubin of thin-film plastic material, such as polyethylene, polypropylene, polyvinyl chloride or other synthetic resins capable of being extruded as a continuous thin-film plastic sheet. Polyvinyl chloride is preferred because its dipolar composition has good heat sealing characteristics when exposed to dielectric heating devices of the type that may be used for heat welding so as to adhere the layers of plastic film together along the edges of the bag as described above. The adhesive layer and the porous material from which the comfort layer is made also may be of a heat weldable synthetic resin. A woven or non-woven fiberous material is preferred for the comfort layer. A similar material impregnated with a pressure sensitive adhesive composition is preferred for the adhesive layer.

Heat welding is done preferably by dielectric heating with high frequency radiant energy, although other types of heat welding and sealing may be used such as ultrasonic or hot press sealing. The layers of plastic film and also the adhesive layer comfort layer may be adhered together by adhesion seams formed by means other than heat welding, such as by solvent welding or by an additional intermediate layer of adhesive composition. Solvent welding involves swabbing opposing surfaces of adjacent film layers with a solvent for the film materials, such as cyclohexanone where the films are of a polyvinyl chloride resin. Similarly, one or more of the opposing layer surfaces may be coated with an adhesive composition that adheres tightly to the plastic film or other material of the layers to be integrally joined together.

Comfort layer 14 also may be adheringly secured to inner bag wall 10 by side seam 15. Although the material of comfort layer 14 may be heat weldable along with the bag wall material, it need not be - because as the walls of the bag melt in the area of seam 15, the molten resin will flow into the pores and capillaries of the porous comfort layer 14. Upon cooling, the flowed resin material securely affixes the comfort layer to the inner wall of the bag along seam 15.

A tapered lower part 17 of bag 9 has an outlet opening 18 to permit the bag to be emptied during use without the necessity of removing the bag from around the stoma. Outlet opening 18 may be closed by means of a clip 20 through which the tapered end 17 is looped as shown in Fig. 2. After looping the bag part 17 around central camming portion 21 of clip 20, the camming portion is pushed down between the ϋ—shaped sides of the clip so that a catch member 23 engages the underside of a transverse bar 24.

O P Referring now to Figs. 3 and 4, there is shown a carrying ring, generally designated 30, having an outer snap ring 31 with a central aperture defined by an inner wall 32 for receiving an inner snap ring 33 which in turn, has a central aperture 34. Inner wall 32 of the outer ring aperture includes a pair of conical surfaces 36 and 37 spaced radially apart so as to form a groove 38 and an adjacent ridge 39. Similarly, an outer wall 40 of the inner ring 33 has a pair of conical surfaces 41 and 42 spaced radially apart so as to form a groove 43 and an adjacent ridge 44. Inner wall 32 of outer ring 31 and outer wall 40 of inner ring 33 function as interlocking clamping surfaces and cause these two rings to be joined in interlocking relationship as a single carrying ring 30 when inner ring 31 is in its clamping position within the outer ring aperture. Snap rings 31 and 33 are preferably made by injection molding a suitable polymeric material.

The outer diameter of inner rin surfaces 41 and 42 relative to the inner diameter of outer ring surfaces 36 and 37 are such that ridge 44 has a snap fit within groove 38 and ridge 39 has a snap fit within groove 43 so that once the inner ring is forced withing the outer ring by pressing the two rings axially together an interlocking joint is formed which provides positive interference between inner ring wall 40 and outer ring wall 32. This positive interference permanently retains inner ring 33 within outer ring 31 unless one or more of the clamping surfaces 36, 37, 41 and 42 are distorted sufficiently to break the interlocking relationship. The diameters

OMPI of the outer surfaces of inner ring 33 relative to diameters of the inner surfaces of outer ring 31 are also selected so that there is sufficient space between these opposing surfaces to receive and sealingly clamp at least an extension 47 of the inner wall 10 of bag 9 which extends around an inlet opening 48. Preferably, the gap between the inner and outer clamping surfaces is such that additional layers of material also may be securely clamped between the snap rings as described further below. Due to the ridge and groove arrangement discribed herein, the frictional surface area for clamping the bag wall an any other layers between the two rings can be increased by as much as about 30% to 40% relative to an even surface.

On the exterior surface of inner wall 10 there is preferably provided a comfort layer 14 of a porous material such as a woven or non-woven fibrous material. The material selected for this layer is highly porous and comfortable when resting against the skin of the body. Adjacent to ring 30 and interiorly to comfort layer 14 is preferably an annular adhesive layer 45 for adheringly engaging the body skin so as to firmly and sealingly secure ring 30 in position around the stoma. Adhesive layer 45 is preferably of a non-woven fiber inpregnated with a pressure sensitive adhesive composition so that pressure sensitive adhesion is provided over substantially the entire inner surface of this layer. The annular portions of layer 45 extending radially beyond carrying ring 30 preferably have a removable plastic covering 46 which prevents premature adhesion of adhesive layer 45 to the body or some other surface.

» Inner bag wall 10 has an inlet opening 48 preferably of a diameter approximately equal to the diameter of aperture 34 of inner snap ring 33. Comfort layer 14 and adhesive layer 45 have corresponding apertures 49 and 50, respectively. Inner ring aperture 34 is aligned with inlet opening 48 in inner bag wall 10. Aperture 49 of comfort layer 14 and aperture 50 of adhesive layer 45 are similarly aligned with inlet openin 48. In order to assembly the carrying ring and other bag components into a unitary structure, inner ring 33 is first placed within bag interior 11. Thereafter, aperture 32 of outer ring 31 is aligned with outer surface 40 of inner ring 33 and the two rings are pressed together with sufficient force to cause inner ring 33 to snap within aperture 32 of outer ring 31 with portions of inner wall 10, comfort layer 14 and adhesive layer 45 sealingly clamped together in the resulting joint between the two snap rings as illustrated best in Fig. 4.

In order to facilitate alignment between aperture 34 of inner ring 33 and the respective opening in the inner bag wall, the comfort layer and the adhesion layer, inner ring 33 and outer ring 31 are preferably pressed into interlocking relationship with these layers clamped therebetween prior to cutting the openings in any of these layers. In other words, inner ring 33 is forced into aperture 32 of outer

' JΕ.EJ

OMFI ring 31 so as to provide the clamping arrangement shown in Fig. 4 while the bag wall 10 and layers 14 and 45 are continuous sheets of material. As the next step', the portions of clamped layers 45, 14 and 10 overlying inner ring aperture 34 are cut away by passing a punch or similar cutter down into aperture 34 so as to form openings 50, 49 and 48, respectively.

The joining of bag walls 10 and 12 along side edge adhesion seam 15 can be done either before or after- appropriate layers of the material have been clambed between the snap rings, and either before or after cutting of the central apertures 48, 49 and 50. After formation of these aligned openings, an annular gasket 54 of karaya gum or other ring to body sealing material is placed over the inner surface of carrying ring 30. Gasket 54 preferably has a shoulder 56 around a central aperture 57 which forms an inlet passageway into bag interior 11. Shoulder 56 fits snugly within inner ring aperture 34 so as to hold gasket 54 in position with its aperture 57 in alignment with aperture 48 in inner bag wall 10. Gasket 54 absorbs moisture in the presence of perspiration and other body fluids to form a gel-like seal around the stoma and may be made for other vegetable gums having similar properties, such as tragacanth gum. In order to protect the sterility and cleanliness of gasket 54 and the bag interior, a protective layer 60 of thin film, preferably transparent plastic material is placed over the inner surface of gasket 54. If layer 60 is cut from an extruded sheet and placed in position immediately after extrusion so that it is still hot, it will

O Pr adhere firmly to the inner surface of gasket 54 but subsequently can be easily pulled away to expose the bag entranceway 57 when readying the bag for placement of stoma 55 into this entranceway.

The parts of the invention shown in exploded section in Fig. 3 are shown in their assembled positions in Fig. 4. In this embodiment, there are three layers each of a different material clamped between the inner and outer snap rings, namely, inner bag wall 10, comfort layer 14 and adhesive tape 45. A particularly important feature of the invention is 'that each layer clamped between the snap rings is caused to bend sharply, first in one direction around ridge 39 and then in another direction around ridge 44. The gap between rings 31 and 33 is such that ridges 39 and 44 also compresses these layers firmly into grooves 43 and 38, respectively. This zig-zag clamping structure significantly increases the area of frictional contact between the snap rings and the layer(s) of material clamped therebetween as compared to the area of contact that otherwise would be provided by the thickness of concentric snap rings 31 and 33. Thus, the layer(s) of material clamped between the rings is (are) held securely in position not only by the interlocking positive interference between the ridges and grooves but also by the area of the frictional contact provided by the abutting relation between outer surface 40 on inner ring 33 and inner surface 32 of outer ring 31. Outer ring 31 includes a pair of opposing apertures

62-62, one positioned preferably at about 180° from the other around the circumference of carrying ring

30. Each aperture 62 includes a ledge 63 positioned _» so as to coact with a projecting tongue 65 carried by the head 66 of a fastener body 67 connected to a ring supporting belt 70 passing through an aperture 68 in the end of body 67 opposite from head 66. Belt 70 passes around the waist of a person wearing the stoma bag so as to further support the bag and its associated components in position for use with the stoma in communication with the bag interior through 'inlet 57. Although a single belt is shown for purposes of illustration, multiple belts may also be employed similar to those shown in patent No. 2,684,675 discussed above.

Although fastener 67 may be located inside of adhesive layer 45, the fastener preferably passes through an aperture 72 in the adhesive layer so that belt 70 may pass outside of adhesive layer 45 and inside of comfort layer 14 as illustrated in Figs. 3 and 4. If adhesive layer 45 is of a thin, non-woven material as preferred, fastener head 66 can be easily forced into ring aperture 62 along with a small portion of layer 45 and without the necessity of a preformed aperture 72. If layer 45 is of a woven material or some other material that cannot be easily pierced or forcen into aperture 62 along with head 66, aperture 72 may be provided so as to permit insertion of head 66 into aperture 62 after the other components of. the bag have been assembled. Passage of fastener head 66 through adhesive layer 45 allows the adhesive seal provided by layer 45 to extend entirely around the stoma without being interrupted by the passage of belt 70, which otherwise would have to pass .between a portion of the adhesive layer and body 13.

Because of the effect of moisture upon karaya gum or like materials, it is difficult to obtain significant adhesion between gasket 54 and carrying ring 30. However, in the present invention, although the level of adhesive forces may not be very great, additional adhesion to hold gasket 54 in place during initial set up and positioning of the bag is obtained by a radially inward extension 59 of adhesive layer 45. Adhesive extension 59 overlies the inner surface of inner snap ring 33 as shown in Fig. 4. Further adhesion between gasket 54 and ring 30 also may be provided by the tacky nature of gasket 54 when first formed. This tackiness characteristic is best preserved by packaging the completed stoma bag so that this gasket is not dried out by excessive contact with air prior to use.

In the remaining figures, the same part designations have been used for the same components as in Figs. 3 and 4 even though different arrangements of these components are shown in the embodiments of Figs. 5-8. Referring now to Fig. 5, both adhesive layer 45 and comfort layer 14 of this embodiment are of a material that can be adhered satisfactorily to the material of outer snap ring 31.

r O Accordingly, only the inner wall 10 of the bag is clamped between the outer and inner snap rings 31 and 33, respectively. Adhesive layer 45 is adheringly affixed to an inner surface 58 of outer snap ring 31 and comfort layer 14 is adheringly affixed to an outer surface 61 of outer snap ring 31. Comfort layer 14 also may be adheringly affixed to the edge of bag 9 at side seam 15. If the area of adhesion 61 between comfort layer 14 and outer ring 31 is sufficient to keep this layer in place, the attachment of layer 14 to seam 15 by heat welding or some other form of adhesion is optional.

The manner of adhesion may be by any of the means previously described, such as heat welding, solvent welding or a separate layer of adhesive composition. The selection of a fiberous material- for layers 14 and 45 of this embodiment and a heat weldable material for outer snap ring 31 may facilitate attachment of layers 14 and 45 to this ring since melted ring material will flow into the pores and around the fibers of woven or non— oven layers 14 and 45. This, embodiment also signigicantly increases the adhesion area 59 between adhesive layer 45 and gasket 54.

Referring to Fig. 6, only adhesive layer 45 is clamped between inner and outer snap rings 33 and 31, respectively. This structure may be used where some difficulty may be encountered in attaching the adhesive layer to the carrying ring but relative good adhesion can be obtained between the inner wall 10 of the bag and an outer surface 74 of inner snap ring 33. In this embodiment inner bag wall 10 can be adheringly attached to adhesive layer 45 by heat welding or some other form of adhesion represented by broken line 77 so that an inner annular portion of

» adhesive layer 45 forms a clamped extension 47 of bag wall 10.

Referring to Fig. 7, adhesive layer 45 and comfort layer 14 are both clamped between the inner and outer snap rings 33 and 31, respectively. Adhesive layer 45 also is adheringly affixed to an outer surface 74 of outer ring 31. Inner bag wall 10 is adheringly affixed to comfort layer 14 both along outer seam 15 and along an inner annular area of adhesion represented by broken line 79. Although inner wall 10 may optionally also be adhered to an outer surface of inner ring 33, it preferably is not so adhered in this embodiment but stops at an inner edge 80 of adhesion area 79. This structure may be used where relatively goad adhesion may be obtained between the adhesive layer and the carrying ring and between the inner bag wall and the comfort layer but only relatively poor adhesion can be obtained between the inner bag wall and the carrying ring. The selection of a fiberous material for layer 14 of this embodiment and a heat weldable material for the bag walls may facilitate attachment of layer 14 to wall 10 since melted wall material will flow into the pores and around the fibers of woven or non-woven comfort layer 14 in the areas of seams 15 and 79.

OM Referring to Fig. 8, comfort layer 14 and inner bag wall 10 are both clamped between outer and inner snap rings 31 and 33, respectively. Adhesive layer 45 is adheringly affixed to outer surface 74 of outer ring 31.'Optionally, the inner portions of wall 10 and layer 14 around apertures 48 and 49, respectively, also may be adheringly affixed to an inner surface 82 of inner snap ring 33, This structure may be used where relatively good adhesion may be obtained between the adhesive layer and the carrying ring, but only relatively poor adhesion can be obtained between the comfort layer and carrying ring, between the - inner bag wall and carrying ring, and between the comfort layer and inner bag wall. In this embodiment, the outer edge 84 of the comfort layer is not adhered to edge seam 15 of the bag but is held in position relative to both the inner bag wall and the carrying ring by the clamping connection provided by the coactiπg clamping surfaces 32 and 40 of snap rings 31 and 33, respectively.. An inner annular extension 85 of porous comfort layer 14 may be inpregnated with an adhesive composition similar to that of adhesive layer 45 so as to improve the adhesion between gasket 54 and carrying ring 30.

The present invention provides a variety of constructions for economically providing stoma bags that are extremely effective and comfortable in use. The design of each of the bag components is such as to facilitate mass production of large numbers of bags. The specific manner of securing the bag layers and other components together can be selected depending on the specific types of materials selected for the different components and the effectiveness of known techniques for adhering those materials together. The methods of manufacture also may utilize conventional machines that are available for assembly of press fitted rings and in this way manufacturing costs can be further minimized.

^■^jREΛ OMPI

Claims

Claims :

1. A bag supportable upon the body of a person for receiving discharges from a stoma, said bag comprising: an inner wall (10, 14) and an outer wall (12) in opposing relationship, the edges of said inner and outer walls being connected to define a hollow bag interior (11) for receiving said discharges and said inner wall having an inlet opening (57) for receiving said stoma so as to place said stoma in communication with said bag interior and a layer of adhesive tape (45) for supporting said bag on said body with said stoma in communication with said bag interior, c h a r a c t e r i z e d in that the bag comprises a carrying ring (30) having an inner snap ring (33) with an outer clamping surface and an outer snap ring (31) with an inner clamping surface, to which carrying ring (30), an extension of said inner bag wall (10, 14) and the layer of adhesive tape (45) are attached, that the said extension of said inner bag wall (10, 14) and/or the adhesive tape (45) are clamped between the clamping surfaces of the inner (33) and outer (31) snap rings, and that the inner (33) and outer (31) snap rings comprise engaging means (36, 37, 41, 42) engaging each other in an interlocking relationship when said inner ring (33) is in its clamping position within said outer ring (31) aperture so that positive interference is provided between engaging means of the rings (31, 33), in order to accomplish a disposable stoma bag.

2. A bag according to claim 1, c h a r a c- t e r i z e d . in that said bag wall extension comprises a continuous portion of said inner bag (10) wall, and that said adhesive layer (45) is compressively clamped between said inner (33) and outer (31) snap rings along with said continuous inner-bag wall (10) portion.

3. A bag according to claim 1, c h a r a c¬ t e r i z e d in that said adhesive layer (45) is secured to said carrying ring (30) by a means of adhesion, and that said inner bag wall (10) extension comprising a continuous portion of said wall is clamped between said inner (33) and outer (31) snap rings.

4. A bag according to claim 1, c h a r a c¬ t e r i z e d in that said inner bag wall (10) extension comprising a continuous portion of said wall is secured to said carrying ring (30). by a means of adhesion and that said adhesive layer (45) is clamped between said inner (33) and outer (31) snap rings.

5. A bag according to claim 1, c h a r a c¬ t e r i z e d in that the inner wall (10) comprises a comfort layer (14) of a porous material covering at least a portion of the external surface of said inner bag wall (10) said comfort layer being located so as to rest against said body when said carrying ring (30) is supported on said body with said stoma in communication with said bag interior (11).

6. A bag according to claims 1 and 5, c h a r a c¬ t e r i z e d in that said comfort layer (14) is secured to said carrying ring (30) by a means of adhesion.

7. A bag according to claims 1 and 5, c h a r a c¬ t e r i z e d in that said bag wall extension comprises a continuous portion of said inner bag wall (10) and that said comfort layer (14) is compressively clamped between said inner (33) and outer (31) snap rings along with said continuous portion of said inner bag wall (10).

8. A bag according to claims 1 and 5, c h a r a c— t e r i z e d in that said comfort layer (14) and said adhesive layer (45) are compressively clamped between said inner (33) and outer (31) snap rings along with said inner bag wall (10) extension.

9. A bag according to claims 1 and 4, c h a r.a c— t e r i z e d in that said inner bag wall (10) is adheringly secured to said adhesive layer (45) so that a portion of said, adhesive, layer (45) provides said inner bag wall (10),extension clamped between said inner (33) and outer (31) snap rings.

10. A bag according to claims 1 and 5, c h a r a c¬ t e r i z e d in that said comfort layer (14) is adhereingly secured to said inner bag wall (10) so that a portion of said comfort layer (45) provides said inner bag wall (10) extension clamped between said inner (33) and outer (31) snap rings.

11. A bag according to claim 1 and 5, c h a r a c¬ t e r i z e d in that said inner bag wall (10) extension comprises a continuous portion of said inner bag wall, and that both said adhesive layer (45) and said comfort layer (14) are secured to said carrying ring (30) by a means of adhesion.

12. A bag according to claim 1, c h a a c¬ t e r i z e d in that a gasket (54) of moisture absorbing gum is carried on said carrying ring (30) so as to sealingly engage a surface of said body adjacent to said stoma when exposed to body fluids.

13. A bag according to claim 12, c h a r a c¬ t e r i z e d in that said gasket (54) has an annular shape, and that said gasket (54) includes an axially extending shoulder (56) extending into an inlet aperture through said inner (33) snap ring so as to provide radial support for said gum layer.

14. A bag according to claim 1, c h a r a c¬ t e r i z e d in that the inner clamping surface of the outer snap ring -(31) includes a first engaging means and said outer clamping surface of the inner snap ring (33) includes a second engaging means, said first engaging means and said second engaging means each comprising a ridge adjacent to a groove, said ridge and groove combination being formed by a first conical surface offset radially relative to a second conical surface, said groove on said inner surface mating with said ridge on said outer surface and said ridge on said inner surface mating with said groove on said outer surface so as to provide said

OMPI interlocking relationship between said inner snap ring and said outer snap ring.

15. A bag according to claim 1, c h a r a c- t e r i z e d in that the outer snap ring includes two apertures (62) one located generally opposite the other for two fasteners (67) one at each end of a belt member (70) for supportably engaging a portion of said body, a ledge (63) in each of said apertures (62), and a tongue (65) on each of said fasteners, said fastener tongue interlocking with said aperture ledge when said fastener head is received within said aperture so as to retain said fasteners within said apertures and support said carrying ring (30) on said belt (70).

16. A bag according to claim 1, c h a r a c¬ t e r i z e d in that the layer of adhesive tape- (45) comprises an inner adhesive surface extending radially beyond an outer edge of said carrying ring (30) so as to adheringly engage a surface of said body, adjacent to said stoma and that said inner adhesive surface is pressure sensitive and is covered with a non-adhesive layer secured to said adhesive layer but peelable therefrom prior to contact between a body surface and said adhesive surface.