Ostomy bag with filter construction

ES 2 602 139 T3

DESCRIPTION

Ostomy bag with a filter construction

The invention relates to an ostomy appliance having a filter construction contained in two sheets, a first sheet and a second sheet. The filter construction is provided with holes in at least one of the foil layers and the holes function as gas inlets. The invention also relates to a method for reducing the number of balloonings and to a method for increasing the time before balloonings occur. Finally, the invention relates to an ostomy appliance to reduce the number of balloonings and to an ostomy appliance to increase the time before balloonings occur. Background

In connection with surgery for a number of diseases in the gastrointestinal tract, one of the consequences in many cases is that the patient is left with an abdominal stoma, such as a colostomy or an ileostomy in the abdominal wall for the discharge of visceral contents. . The discharge of visceral contents, including intestinal gas, cannot be regulated at will. To do so, the user will have to rely on an apparatus to collect the material emerging from said opening into a bag, which is subsequently emptied and / or discarded at a suitable time.

Flatulence discharge, measured by volume, can exceed solid and liquid stool discharge by many hundreds percent, and therefore there is usually a need for continuous or frequent ventilation of the bowel or collection bag. Normally, the emission of flatulence is deodorized with a suitable filter. Usually the active filter is powdered activated carbon, which absorbs H2S which is the main component of the odor of flatulence.

During use of a collection bag, exit debris from a colostomy or ileostomy may stick to the inward-facing side of the filter in the collection bag. Ultimately this will lead to filter clogging, thereby reducing flow through the filter. When the filter is completely blocked it will stop working and the bag will fill with gases and expand, an effect also known as ballooning. This can be embarrassing for the user as the bag will be noticeable through clothing. This can also cause separation of the apparatus from the wearer's skin - or separation of the bag from the wafer.

Summary of the invention

The invention relates to an ostomy appliance with a filter construction. The ostomy appliance bag has a front wall and a back wall. The filter construction has first and second sheets that provide an enclosure for the elements in the filter construction. The filter construction can be fixed inside the bag such that, in use, the filter construction is substantially freely suspended in the bag, which means that the filter construction can follow the movements of the bag, and it can also collapse and bend during use. Orifices are provided in at least one of the first or second sheets to provide gas inlets to the filter construction. During use, such an ostomy appliance will be able to evacuate excess gas through the filter at any time, because the arrangement of the freely suspended filter construction ensures that at least one inlet is always open.

Brief description of the drawings

Figure 1 shows an embodiment of an ostomy appliance according to the invention.

Figures 2 and 3 show another example of an ostomy appliance.

Figure 4 shows an exploded view of the filter construction of the example of Figures 2 and 3.

Figure 5 shows yet another embodiment of an ostomy appliance according to the invention.

Figure 6 shows an embodiment of a filter construction provided with a drain opening.

Figure 7 shows an embodiment of the deodorizing filter contained in a three-layer laminar structure.

Figure 8 shows an example of an ostomy appliance. In figure 8 the bag is shown in the first configuration.

Figure 9 shows the same example of the ostomy appliance; however, in Figure 9, the apparatus is shown in the second configuration.

Figure 10 shows the filter construction for use in an ostomy appliance according to the invention.

ES 2 602 139 T3

Figure 11 shows a test setup used for testing ostomy appliance bags according to the invention.

Figures 12 to 14 show test results of ostomy appliances according to the invention.

Detailed description of the invention

In a first aspect, the invention relates to an ostomy appliance according to claim 1.

An ostomy appliance with a filter construction as described above will have excellent properties to prevent, or at least reduce ballooning because the filter construction is freely suspended in the bag.

Freely suspended means that the filter construction can follow the movements of the bag substantially unhindered. The filter construction can only be attached in the area immediately around the vent opening, leaving most (if not all) of the enclosure contour unattached to the ostomy appliance. Alternatively or additionally, the filter construction is attached at discrete points along the surface of the second sheet. This means that, in one embodiment, most of the filter construction can collapse and buckle during use, thereby preventing the filter construction from sticking to the bag walls, and therefore maintaining at least any of the gas inlet or inlets open at all times. Collapsing and bending means that the filter construction gets a wavy shape in the plane of the bag.

In another example, the free suspension of the filter is such that the filter construction is cantilevered to the bag.

Most of the filter construction means that the surface area of ​​the part of the filter construction that is attached is significantly less than the remaining surface area of ​​the filter construction. For example, the set area may constitute less than 20% of the surface area of ​​the filter construction, such as 10% or 5%, or even as little as 1%.

An ostomy appliance is well known in the art. It typically comprises a bag having a front wall and a back wall of gas and liquid impermeable sheet material (for example, polyethylene (PE), polyvinyl chloride (PVC) or ethyl vinyl acetate (EVA)) that is welded or glued around the margins or edge to thereby form a bag defining a waste collection chamber. The bag can be only partially welded or glued around the edge, such that an opening for emptying the bag is arranged at the bottom of the bag. In this case, the bag can be provided with means to close said opening. The bag normally includes a waste inlet opening which, on the outer side, is provided with either mechanical or adhesive coupling means for attachment to a wafer on the outer side, or with a skin-friendly adhesive adapted to adhere directly to the user's abdomen.

Typically, the waste inlet opening is located at the top of the ostomy bag, such that when the user stands up, the waste inlet opening will be in the midline of the ostomy bag. This leaves a larger collection volume below the waste inlet opening. Therefore, the upper part of the ostomy appliance and the pouch is defined as the part closest to the waste inlet opening, and the lower part is defined as the opposite part. The longitudinal direction of the ostomy appliance and the pouch is defined as the top-down direction. The transverse direction of the ostomy appliance, the bag and the filter construction located in the bag is defined as the direction in the plane of the bag perpendicular to the longitudinal direction. The axial direction is defined as the direction of the stoma.

The filter construction comprises first and second foil layers defining an enclosure for the filter construction. The first and second foil layers can be laminated to the surface of the elements (eg, the pre-filter) in the filter construction. Laminate means that the sheets are fixed over the entire surface, such that there is no gap between the elements and the sheet layers. The sheets can be fixed by means of gluing or heat welding. When the first and second foil layers are laminated to the surface of the elements, the foil layers are not necessarily also attached to each other along their contour. If the foil layers are not fixed along their contour, or at least partially unfixed along their contour, the unfixed portions also define gas inlets to the filter construction.

Alternatively, the first and second foil layers can be attached to each other along their entire contour, such that they define an enclosure. In this case, the pre-filter element may be slightly compressed during manufacture in the cross-sectional direction of the filter construction. Compression of the pre-filter element ensures that there is no gap between the sheets and the pre-filter element, thereby reducing the risk of liquid or semi-solid parts of the outlet debris bypassing the pre-filter element. It is therefore ensured that the liquid material entering the filter construction will flow through the pre-filter element.

ES 2 602 139 T3

The foil layers can be attached to each other by welding, which is a quick process to use in manufacturing. Therefore, the sheet itself can be weldable. The sheets can also be fixed to each other by a gluing process, for example using acrylate and / or hot melt adhesive. Furthermore, the sheet can be impermeable to gases and liquids. The use of a material such as PE foil would be suitable. Alternatively, the sheet can be non-woven or textile. However, it is necessary to ensure that the liquid or semi-solid parts of the outlet debris travel at least some distance through the pre-filter element before reaching the deodorizing element. Therefore, the sheets immediately around the deodorizing element have to be impermeable to gases and liquids. In one embodiment, the gas and liquid impermeable sheets can be arranged at a distance of at least 3 cm from the deodorizing element. In another embodiment, the gas and liquid impermeable sheets can be arranged at a distance of only 15 mm from the deodorizing element. This depends on the type of waste exiting the bag, as described below.

In one embodiment, the filter construction includes a deodorizing filter within the enclosure. Alternatively, the deodorizing filter may be located on the outer surface of the bag, such that it communicates with the vent opening in the bag. The deodorizing filter can also be located inside the bag communicating with the ventilation opening, but outside the enclosure and communicating with the gas outlet.

The deodorizing filter can be provided in the form of filter packs commonly used for ostomy bags. Typically, the deodorizing filter will have a foil layer, laminated to the surfaces of the deodorizing filter, that is parallel to the direction of gas flow. This ensures that the gas is forced to flow in the direction of the deodorizing filter intended for the gas flow. Hence, adequate deodorization is achieved. The filter construction can include more than one deodorizing filter, such as two or three. The number of ventilation openings in the bag should correspond to the number of deodorizing filters in the filter construction. By way of example, a filter pack having a shape and flow path such as Filtrodor®, available from Coloplast A / S, can be used. This filter container comprises a disk-shaped foam element, in which the foam is impregnated with carbon. The foam element is covered with a gas-impermeable sheet on both sides of the disk, except for a centrally drilled hole in one of the sheets. This hole serves as a gas outlet for the deodorizing filter and the periphery of the element serves as a gas inlet. The direction of gas flow through the deodorizing filter can also be opposite, such that the gas enters the deodorizing filter centrally and exits at the periphery. When the gas has traveled the distance from the periphery of the disk to the center (or vice versa), it is adequately deodorized. The diameter of an element of this type can be approximately 20 to 25 mm, but it can be larger or smaller depending on the deodorizing capacity.

The deodorizing filter can also be elongated in shape, with an inlet at one end and an outlet at the other. Said deodorizing filter can be of the type described in European patent number EP0235928B1.

The deodorizing filter could be a carbon-filled porous material such as foam, felt, nonwoven or the like, or the activated carbon could be based on a carbonated material such as, for example, carbonated viscose or the like. The carbon could be activated or not, applying catalyst compounds such as copper oxide, chromium oxide, potassium permanganate or other catalyst compounds.

In one example, at least one of the first and / or second sheet layers is provided with holes with a diameter of about 0.1 to 2.0 mm. Both film layers can also be provided with holes. These holes serve as gas inlets to allow gas to enter the filter construction. The small size of the holes helps prevent semi-solid material, and to some extent liquid, from entering the filter construction but allows gas to enter.

The holes in the foil layers minimize the risk of all inlets being plugged by stoma outlet debris - even if the outlet debris itself is placed near the filter construction in the bag. The position of the exit debris depends on the movement of the user (lying down or sitting) and the type of exit debris. Usually the exit debris will be near the back wall of the ostomy bag. In this case, the holes in the sheet opposite the front wall will be accessible to gas. The outlet debris may also be close to the front wall and in this case the holes in the sheet opposite the rear wall will be accessible to the gas.

Holes can be made by drilling, burning and etching, or by using a laser, drill, needle, or punch. The number of holes can be anything from 1 hole for an ileostomy bag to more than 150 holes for a colostomy bag. The number of orifices depends on the size of the filter construction and the type of debris exiting the stoma.

Use of the filter construction of this invention in connection with an ileostomy as well as a colostomy is contemplated. The two types of stomata usually provide different types of outlet debris. For an ileostomy, the exit residues are usually finer and more viscous, while the exit residues for a colostomy are usually more of the puree type. However, the type of waste output may also depend on the intake of food and liquids - hence, hereinafter referred to as waste

ES 2 602 139 T3 fine exit (from viscous to liquid) and coarse exit residues (puree type) regardless of whether they come from an ileostomy or a colostomy.

For thick outlet debris, there is a risk that the orifices, which serve as gas inlets, will become clogged due to the caking of the outlet debris over the orifices. Since the exit debris has a relatively thick consistency, it cannot pass completely through the hole. Therefore, the orifice can fill with exit debris and therefore stop working as a gas inlet. For fine exit debris, the holes will not fill with exit debris and therefore will not be clogged because exit debris can pass through the holes. Therefore, a larger number of holes (gas inlets) is required for coarse outlet debris than for fine outlet debris. For fine outlet residues a number of holes (gas inlets) of 2 or only 1 hole (gas inlet) can be used, while for coarse outlet residues up to 150 holes (gas inlets) can be used. For thick outlet debris, at least more than 50 holes (gas inlets) can be used.

Not only the number of holes can depend on the type of exit residue, but also the size of the holes. This is because coarse outlet debris is unlikely to pass through a hole (gas inlet) because these holes are typically less than 2mm in diameter. On the other hand, it is unlikely that a small hole can stop fine exit debris. Therefore, for fine outlet debris few and larger holes (gas inlets) are preferable, and for coarse outlet debris many and small orifices (gas inlets) are preferable.

When the size of the holes is given as the diameter size, it refers to a larger diameter of the hole in case the hole is not circular but rather elliptical. If the hole is more angular, then again a maximum diameter is referred to, which in this case may be the maximum diagonal dimension through the hole.

A first distance between two neighboring ports may be such that liquid cannot travel from one port to the neighboring port in normal use time. A second distance from the deodorizing element to the nearest gas inlet may be such that liquid cannot travel from the nearest gas inlet to the deodorizing element in normal usage time.

Throughout the application, whenever reference is made to a first distance between the orifices or a second distance between the gas inlets and the deodorizing element, these distances are in the flat direction of the filter construction. Therefore, the second distance is defined as the distance in one direction in the plane of the sheets of the filter construction, from the gas inlet closest to the deodorizing filter to the margin of the deodorizing filter closest to the same inlet of gas. The planar direction is defined by the foil layers of the filter construction such that each foil extends in the planar direction.

For coarse outlet debris, it is contemplated that clogging of the filter construction occurs when all gas inlets are blocked by the outlet debris. The gas inlets can be blocked by semi-solid material caked through the hole, thereby closing the hole. The first distance between neighboring holes and the second distance from the gas inlets to the deodorizing element ensures that exit debris that clogs a hole will not be able to travel through the pre-filter material along the surface of the sheet and up to the next hole or to the deodorizing element and clog them as well. Liquid and semi-solid matter entering the deodorizing element can deprive this element of its ability to deodorize flatulent gas. Tests have shown that if the first distance between the two gas inlets or the second distance between a gas inlet and the deodorizing element is greater than 10 mm in the flat direction, then the semi-solid or liquid matter will not be able to travel through the pre-filter material in normal usage time. Similarly, these distances minimize the risk of caking of exit debris across the surface of the filter construction plugging too many gas inlets.

In one example, the second distance is at least 5mm. Only a small amount of liquid will be able to enter the pre-filter element due to the small holes in the lamellae of the filter construction, thus only a short distance is required to stop this liquid. However, the second distance can be about 3 cm. Again, there is a difference between coarse and fine exit residues. Coarse outlet debris will not be able to travel very far into the pre-filter element, so the second distance between the gas inlets and the deodorizing filter may be rather small, for example as little as 5mm. In one embodiment, the minimum distance between the deodorizing element and the gas inlet is more than 15mm. In this way, it is guaranteed that no liquid or semi-solid matter will reach the deodorizing element during the normal time of use.

However, fine outlet debris can travel further through the pre-filter element, so the second distance between the gas inlets and the deodorizing filter should be greater, for example at least 3 cm.

A third distance between the gas inlets and the edge of the filter construction can be more than 5mm. When the gas inlets are close to the edge of the filter construction, there is no nearby hole in the direction of the edge. Therefore, the distance may be less in this case.

ES 2 602 139 T3

The reed enclosure defining the filter construction may be provided with a drainage opening facing downward in the ostomy bag - that is, facing the bottom of the ostomy bag. This bottom-facing drain opening provides the opportunity for particularly fine outlet debris to drain from the filter construction. The opening may be provided with a one-way valve, such that outlet debris in the bag is prevented from entering the filter construction through this opening. A one-way valve is well known in the art and can be arranged, for example, as a reed valve.

The filter construction may further include a flange that surrounds the gas outlet. The filter flange can be an injection molded flange. This filter flange is intended to provide an element for welding the filter construction to the ostomy bag. Thus, the positioning of the filter construction is independent of the manufacture of the ostomy bag and can be done during manufacture of the ostomy bag or at any time thereafter. Furthermore, the filter flange is made of a material that is substantially non-conductive and capable of absorbing heat. Therefore, the heat from the welding process is not transferred to the filter construction. In this way, the filter construction can be manufactured as a finished element, including the pre-filter element and the deodorizing filter, and then welded to the bag without risk of the sheets and the pre-filter element being welded together.

The filter flange can be made of a material such as PE or EVA, both of which are capable of being rapidly welded to the ostomy bag. Welding can be carried out, for example, at 160 ° C for about half a second. The thickness of the flange should be above about 0.5mm to be able to absorb the welding heat in order to prevent the sheets and the pre-filter element from being welded together. The upper limit for thickness is controlled by the requirement for an inconspicuous bag - therefore it should be below about 1mm.

The filter flange can be glued to the bag rather than welded to it. This can be done using an acrylate or a hot melt adhesive.

The filter construction can also be welded directly to the ostomy bag, which means that the filter flange can be omitted. In this case, the deodorizing filter is welded directly to the bag, that is, the sheet covering the deodorizing filter is welded to the front or back wall of the ostomy bag.

In one embodiment of the invention, the sheets covering the deodorizing filter can be made of a three-layer sheet structure, laminated to the deodorizing filter. In this case, the sheets can be made of gas-impermeable and liquid-impermeable barrier sheets, such that gases and liquids are prevented from exiting the filter at any position other than the defined gas outlet. The three-layer structure may be composed of an outer foil layer, which is adapted to be welded to the bag foil, an intermediate foil layer adapted to serve as a protective intermediate layer, and an inner foil layer adapted to be laminated on the deodorizing filter. The middle layer protects the laminar structure from small perforations that occur through the layers. The protective ability is provided by ensuring that the intermediate foil layer has a significantly higher melting temperature than the outer and inner foil layers. For example, the outer and inner foil layers may have a melting temperature between 80 ° C and 150 ° C, and in this situation, the intermediate layer may have a melting temperature greater than 200 ° C. By way of example, the outer and inner layers can be made of a copolymer of ethyl vinyl acetate (EVA) and polyethylene (EVAPE), and the middle layer can be made of polyamide (PA).

A three-layer structure such as the one described can be welded or laminated to the outward-facing side of the deodorizing filter when placed in the ostomy bag. On the inward facing side of the pouch, avoiding small perforations, and gas tightness, are less important because gases leaking through the sheeting will be limited to re-entering the ostomy pouch. However, the three-layer laminar structure can nevertheless be used indoors as well, thereby avoiding the need to use separate sheets. In any case, it is necessary to prevent gas leakage to the outside.

When, as described above, sheet layers are used as cover layers for the deodorizing filter, the filter itself can serve as a heat absorbing flange, because the deodorizing filter can absorb the heat of the welding process.

The pre-filter element can be made of foam material, for example PE or polyurethane (PU). The pore size can be between 15 and 100 PPI, such as 30 or 45 PPI. PPI is a unit that provides a measure for pore size, although it actually refers to the number of pores per inch in the foam material. Felt, fluff, non-woven or any other porous material can also be used. Gas (including solid and / or semi-solid waste material) will enter the pre-filter element through the holes in the foil layers, which provide the gas inlets to the filter construction. Due to the sinuous structure of the foam, most of the liquid and semi-solid waste will be captured in the foam, leaving only the gas to pass through the foam to reach the deodorizing filter.

ES 2 602 139 T3

The thickness of the pre-filter element can be between 1 and 5 mm, such as about 2 or 3 mm. The thickness is defined as the dimension in the direction through the filter construction corresponding to the dimension of the pre-filter element in the direction from the first foil layer to the second foil layer.

The area of ​​the pre-filter element can be so large that it has almost the same area as the front or rear wall of the bag. However, there needs to be room for manufacturing tolerances. The area of ​​the pre-filter element can be as little as 10% of the area of ​​the front or rear wall, considered in the plane of the bag. This will be the case if a large bag is used, for example a maxi-bag. The area of ​​the pre-filter element can be up to 80 or 90% of the area of ​​the front or rear wall of the bag. This can be the case especially for small bags, for example for a mini-bag.

A large prefilter element can be advantageous for bags filled with fine outlet debris, because it is difficult to completely prevent fine outlet debris from entering the prefilter element. Therefore, a large volume of foam is required to prevent fine outlet debris from reaching the deodorizing filter. A large pre-filter element can also be advantageous for bags filled with thick outlet debris, because a large number of gas inlets are necessary to ensure that at least some gas inlets are open. As mentioned above, when thick outlet debris is present in the bag, the gas inlets will be blocked due to caking of the outlet debris over the inlet ports. Therefore, a large area of ​​foil with gas inlets is required when the bag is filled with coarse outlet debris.

The gas outlet of the filter construction communicates with the vent opening through a hole or slit in the ostomy bag, so that the gas exiting the gas outlet enters through the vent and exits to the environment , or through the deodorizing filter if it is arranged outside the bag. Communication can be accomplished by placing the gas outlet aligned with the vent opening, or at least in the immediate vicinity of the vent opening. The ventilation opening should be enclosed, for example by welding around the ventilation opening, so as to prevent gas from the bag from exiting the ventilation opening without having passed through the filter construction. Typically this can be ensured by welding the filter construction to the ostomy bag in an uninterrupted weld so that the gas outlet and vent are located within the limits of the weld.

The filter construction may further include a membrane located at the gas outlet. This membrane is permeable to gases, but impervious to moisture. The membrane can be microporous and hydrophobic, and made of a material such as Goretex® or Tyvek®. The membrane should be able to provide a cross flow of 100 to 550 ml / min at a pressure difference of 0.01 bar, for example 250 ml / min or 350 ml / min.

The membrane can be fixed, for example adhered, to the surface of the deodorizing filter, that is to say between the surface of the deodorizing filter and the inner surface of the second sheet. Alternatively, the membrane is located on the outside of the second sheet - that is, between the gas outlet and the vent opening in the bag.

The foil layers of the filter construction may contain the pre-filter element, the deodorizing filter, and the membrane.

In an embodiment where the enclosure includes the deodorizing filter, the pre-filter element comprises a recess for the deodorizing filter. The recess may be disc-shaped to accommodate a disc-shaped deodorizing filter. The gas inlets are located near the periphery of the filter construction, and the deodorizing filter has its own gas inlet along the periphery thereof, and an outlet in a substantially central arrangement.

The prefilter element can be provided as an annular foam element. It can have a circular or angular outer periphery. A part (eg the central part) of the pre-filter element is removed by drilling or cutting a recess in the pre-filter element, thereby leaving space for the deodorizing filter. Preferably, the recess of the deodorizing filter substantially coincides with the outer contour of the deodorizing filter. If the deodorizing filter is disc-shaped, then the recess of the deodorizing filter is generally disc-shaped, and if the deodorizing filter is angular or banana-shaped, the recess for the deodorizing filter will be provided generally of such shape. Matching the cutout for the deodorizing filter to the deodorizing filter provides a more compact structure. Gas entering the filter construction through the gas inlets at the periphery will travel through the pre-filter element to the inner periphery of the pre-filter element, and from there to the deodorizing filter. The gas will then travel transversely through the deodorizing filter and exit the filter construction at the opening of one of the foil layers that provides the gas outlet.

Such a filter construction will be compact and easy to place anywhere in the ostomy bag, depending on manufacturing or configuration needs.

In one embodiment, the pre-filter element is located close to the deodorizing filter such that the two are located in mutual juxtaposition within the filter construction. In such a construction, the deodorizing filter will be located at one end of the filter construction. In other words, the prefilter and the element

ES 2 602 139 T3 deodorizer can be placed sequentially. Therefore, the filter construction can be elongated and preferably somewhat curved, such that it can follow the contour of the ostomy bag. In a related embodiment, the pre-filter element and the deodorizing filter are located in the same plane. Alternatively, the deodorizing filter is located on top of the pre-filter element.

An inspection window may be provided in the pre-filter element, such that the pre-filter element is generally a disk-shaped element having a circular hole with a diameter of at least the diameter of the opening of the filter. debris inlet, where the foil layers of the filter construction are welded along the periphery of the circular hole in the pre-filter element.

To provide a transparent inspection window, it is necessary for the foil layers to be transparent or to be removed from the circular hole.

The inspection window can be located off-center in the pre-filter element, and the deodorizing filter is located in a recess for the deodorizing filter.

The inspection window can be positioned so as to leave a thin band of the prefilter element over the debris inlet opening and a larger area with the recess for the deodorizing filter under the deodorizing inlet opening. Thus, the deodorizing filter can be placed under the debris inlet opening. However, the inspection window can also be positioned such that there is a thin band of the pre-filter element below the debris inlet opening and the larger area including the recess for the deodorizing filter and the deodorizing filter is positioned over the waste inlet opening.

The stoma inspection window allows a user to inspect the stoma and the area around the stoma from outside the ostomy appliance. This requires that part of the front wall of the bag be transparent. In a specific embodiment, the diameters of the individual parts can be as follows: the deodorizing filter, 30mm, the prefilter element, 110mm, and the inspection window in the prefilter element, 70mm.

The inspection window can be provided because the pre-filter element is banana-shaped and located over the stoma and therefore not in the path of vision to the stoma. The pre-filter element can be placed above the debris inlet opening, and partially around it. This pre-filter element may have a circular hole in the center of the banana shape to provide space for the deodorizing filter.

A filter flap, as described in European patent EP1578308B1, in an ostomy appliance ensures that if the flow through the filter construction is too high, such that the front and rear walls of the bag begin to collapse together producing a flattening, then it is possible to partially or totally close the ventilation opening of the bag with the flap described in said patent.

A particularly interesting embodiment of the invention relates to an ostomy appliance according to the first aspect and

- wherein the gas inlets have a diameter of at least 1mm, such as about 2mm and,

- in which the area of ​​the prefilter element is greater than 40% of the area of ​​the rear wall.

Such an ostomy appliance is particularly useful for use with an ileostomy, because it has few, large holes, and a large area of ​​the prefilter element. Thus, it utilizes the fact that it is not possible to prevent fine outlet debris from entering the prefilter, but the prefilter element is large enough to be able to contain it during normal use time for ileostomy bags. These large holes make it (almost) impossible for fine outlet debris from an ileostomy to clog the holes by caking out debris on top of them.

By providing an area of ​​the pre-filter element greater than 40% of the area of ​​the back wall, a suitable amount of porous material will be present even if the porous material is only 5mm thick. This will still leave an adequate volume of porous material so that the pre-filter element can handle the amount of liquid entering the pre-filter element.

Another interesting embodiment of the invention relates to an ostomy appliance according to a first aspect and

- in which the number of gas inlets is greater than 50 and they are arranged in both the first and second plates,

- wherein the gas inlets comprise holes having a diameter of less than 1mm, such as about 0.5mm, as well as holes having a diameter of about 1mm or more, such as about 2mm.

Such an ostomy appliance is particularly useful for use with a colostomy because most of the exit debris that produces a colostomy is rather thick and therefore, as has been

ES 2 602 139 T3 described above, the filter construction will be clogged because the outlet debris is caked across the surface of the filter construction - therefore it is necessary that the number of holes be large and that they are located on both blades to prevent all clogging. Furthermore, the outlet debris producing a colostomy may also comprise finer exit debris - therefore it is advantageous if the diameter of the gas inlets varies.

In another aspect of the invention, the invention relates to a method for reducing the number of balloonings that occur in an ostomy appliance, as defined in claim 17.

Clinical trials have shown that ostomy appliances according to this invention can reduce the number of balloonings that occur by more than 50% - see next paragraph. This means that the user will have to undergo fewer balloonings when wearing an ostomy appliance according to this invention, thus leading to less embarrassment and less disengagement of the pouch from the wafer, or the appliance from the wafer. of the user's skin.

In another aspect of the invention, the invention relates to a method of increasing the time in an ostomy appliance before ballooning occurs, as defined in claim 19.

Clinical trials have shown that ostomy appliances according to this invention can increase the time before ballooning occurs by more than 70% - see next paragraph. This means that a user will be able to wear an ostomy appliance according to the invention for a longer time before having problems with ballooning. This can lead to better and more uninterrupted sleep at night, because the user does not have to get up to let air out of the ostomy appliance.

The ostomy appliance can be placed around a colostomy, and the first and second layers of foil can be provided with gas inlets in excess of 50. The number of gas inlets to be used with a colostomy can also be greater. than 75, such as greater than 100 and even greater than 150 holes.

The ostomy appliance can be placed around an ileostomy and at least one of the foil layers can be provided with at least one gas inlet with a diameter of at least 1 mm, and the prefilter element has a volume large enough to handle liquid outlet debris entering the pre-filter element during normal usage time. In this embodiment, the number of gas inlets can be 2 holes.

A volume large enough to handle liquid outlet debris means that the thickness of the prefilter (in the axial direction of the stoma) is at least 5mm, and the area of ​​the prefilter in the plane of the filter construction is at least 5mm. less 40% of the area of ​​the posterior wall.

Clinical trials

The ostomy appliances described above have been tested by users with a colostomy (20 users) and by users with an ileostomy (20 users). The tests have been compared with reference ostomy appliances comprising two filter constructions, each with a 50mm x 10mm x 3mm porous material prefilter and a 30mm x 7mm x 3mm carbonated foam deodorizing filter. . The study was designed as an open-label, randomized, crossover study. All users wore one-piece ostomy appliances and normally had to experience ballooning problems, at least once a week. Users were instructed to change the ostomy appliance when experiencing ballooning, and otherwise follow the normal change pattern.

Both types of users experienced an increase in the time before ballooning and a decrease in the number of ballooning that occurred.

For colostomy users, the number of reference ostomy appliances tested was 567 appliances and the number of ostomy appliances according to this invention was 526 appliances. The number of balloonings in the reference apparatuses was 129 and the number of balloonings in the apparatuses according to this invention was 59. Therefore the number of balloonings experienced by the apparatuses of this invention was reduced by 52%.

For ileostomy users, the number of reference ostomy appliances tested was 294 appliances and the number of ostomy appliances according to this invention was 283 appliances. The number of balloonings in the reference apparatuses was 161 and the number of balloonings in the apparatuses according to this invention was 74. Therefore the number of balloonings experienced by the apparatuses of this invention was reduced by 62%.

Colostomy users who tried the reference appliances experienced an average balloonization approximately every 1.5 days (0.72 balloonings / user / day). When the same users tried the ostomy appliances according to this invention, they experienced an average ballooning approximately every 4 days (0.26 balloonings / user / day). Therefore, the time before ballooning occurred increased by 74%.

ES 2 602 139 T3

Ileostomy users who tried the reference appliances experienced an average nearly daily ballooning (0.90 balloonings / user / day). When the same users tried the ostomy appliances according to this invention, they experienced an average ballooning approximately every 3 days (0.34 balloonings / user / day). Therefore, the time before ballooning occurred increased by 82%.

Example - filter construction test

The test was carried out using a filter tester that can hold an ostomy bag (= ostomy appliance) while monitoring pressure and air flow. The apparatus includes a pressure differential meter to monitor pressure and a flow controller to monitor air flow. Additionally, the apparatus can apply a controlled simulation of a contamination event to an ostomy bag filter. The filter tester applies controlled handling and shaking of an ostomy bag containing simulated colostomy or ileostomy outlet debris. Simulated colostomy exit residues have a mash-like consistency and simulated ileostomy exit residues have a viscous-like consistency.

The test was carried out by monitoring an ostomy bag containing a medium of simulated colostomy outlet debris on the filter tester. After this, the ostomy bag was inflated to 10 mbar. When the pressure was stable at 10 mbar, the flow through the uncontaminated filter construction was determined by reading the value from the flow controller.

When the uncontaminated flow had been noted, the ostomy bag was deflated and the first contamination cycle was performed allowing the handling plate to move forward into the ostomy bag and handle the exit debris contained in the ostomy bag. ostomy, resulting in controlled contamination of the surfaces within the ostomy bag, including the filter construction.

When the cycle ended, the ostomy bag was inflated again to 10 mbar and the flow through the filter construction was determined as described above.

This contamination step was repeated until the filter construction became clogged. The flow through the filter construction was determined at 10 mbar for each contamination cycle.

Different series of tests were carried out.

In a first series of tests, ostomy bags with a filter construction according to this invention were tested and compared to ostomy bags with a reference filter construction. The filter construction according to this invention included a pre-filter element with a generally circular periphery of approximately 110mm and with an inspection hole of approximately 60mm off-center. The filter construction was further provided with a hole for a deodorizing element of approximately 30 mm, located at the bottom of the pre-filter element. The reference filter construction comprises a 50mm x 10mm x 3mm porous material prefilter and a 30mm x 7mm x 3mm carbonized foam deodorizing filter.

The ostomy bags according to this invention were of two different classes. In series 1.1., The ostomy bags were bags adapted to be used with a colostomy and therefore were provided with 96 holes that acted as gas inlets. The holes were drilled with a needle with a diameter of less than 1 mm; about 0.5 mm. 6 holes of approximately 1mm diameter were included. In this series, four ostomy bags according to this invention, and five reference bags, were tested. All the bags (the sample bags and the reference bags) were filled with an assay medium comparable to the aforementioned mash-type outlet residue. The table below shows how many contamination cycles each bag was subjected to before there was no flow through the bag.

<td>Ostomy bag</td><td>colostomy sample 1</td><td>colostomy sample 2</td><td>colostomy sample 3</td><td>sample of colostomy 4</td><td></td>

<td>pollution cycles</td><td> 11</td><td> 9</td><td> 15</td><td> 16</td><td></td>

<td>ostomy bag</td><td>ref. 1</td><td>ref. two</td><td>ref. 3</td><td>ref. 4</td><td>ref. 5</td>

<td>pollution cycles</td><td> 2</td><td> 1</td><td> 1</td><td> 1</td><td> 2</td>

Table 1

From Table 1 above it appears that the ostomy bags according to this invention (sample 1 to sample 4) and filled with colostomy-type outlet residue greatly outperformed the reference bags (reference 1 to reference 5). On average, the ostomy bags according to this invention lasted 13 contamination cycles compared to only 1 to 2 cycles for the reference bags.

Series 1.2 comprises ostomy bags according to the invention and adapted to be used with an ileostomy. These bags were therefore provided with 2 holes of approximately 1 mm in diameter that acted

ES 2 602 139 T3 as gas inlets. In this series, four ostomy bags according to this invention, and five reference bags, were tested. All the bags (the sample bags and the reference bags) were filled with an assay medium comparable to the aforementioned viscous type exit residue. The table below shows how many contamination cycles each bag was subjected to before there was no flow through the bag.

<td>Ostomy bag</td><td>sample of ileostomy 1</td><td>sample of ileostomy 2</td><td>sample of ileostomy 3</td><td>sample of ileostomy 4</td><td></td>

<td>cycles of contamination</td><td> 12</td><td> 13</td><td> 11</td><td> 12</td><td></td>

<td>ostomy bag</td><td>ref. 1</td><td>ref. two</td><td>ref. 3</td><td>ref. 4</td><td>ref. 5</td>

<td>cycles of contamination</td><td> 1</td><td> 1</td><td> 1</td><td> 1</td><td> 1</td>

Table 2

From Table 2 above it appears that the ostomy bags according to this invention (sample 1 to sample 4) and filled with ileostomy-type outlet residue greatly outperformed the reference bag (reference 1 to reference 5). On average, the ostomy bags according to this invention lasted 12 contamination cycles compared to only 1 cycle for the reference bag.

The second series of tests concerns the influence of hole size. Only ileostomy bags were tested in this series because the exit residue from a colostomy can include both fine and thick exit residues. Therefore, the influence of orifice sizes is most important in tests for bags that include only the fine exit residues. In series 2.1 ileostomy bags with 2 mm holes were tested. These results were compared with series 2.2 comprising ileostomy bags with 1 mm holes. The following Table 3 shows the results of these two series of tests.

<td rowspan="2">2.1 2 hole series mm</td><td>ostomy bag</td><td>ileostomy sample 1</td><td>ileostomy sample 2</td><td>ileostomy sample 3</td><td>ileostomy sample 4</td>

<td>pollution cycles</td><td> 10</td><td> 8</td><td> 9</td><td> 9</td>

<td rowspan="2">Series 2.2 1-hole mm</td><td>ostomy bag</td><td>ileostomy sample 1</td><td>ileostomy sample 2</td><td>ileostomy sample 3</td><td>ileostomy sample 4</td>

<td>pollution cycles</td><td> 4</td><td> 3</td><td> 4</td><td> 4</td>

Table 3

The results in the table above show that 1mm holes are less preferable than 2mm holes. This is because fine outlet debris can clog smaller holes (1mm) and since the filter construction comprises only 2 gas inlets, it is very important that both are kept open. The 2mm holes will not be clogged by fine outlet debris. In addition, the large pre-filter element can handle (contain) exit debris entering the pre-filter element - for at least approximately 9 cycles (2.1 series).

Detailed description of the drawings

Figure 1 shows an ostomy appliance 1 according to an embodiment of the invention. The ostomy appliance comprises a bag having a rear wall 2 and a front wall 3, which are welded together along its edge (not shown). The rear wall 2 has a waste inlet opening 4, which in this embodiment is surrounded by a skin-friendly adhesive 5, therefore it is called a one-piece appliance. Stoma 6 is also shown. The filter construction 10 in the ostomy appliance comprises a first sheet layer 11 and a second sheet layer 12, welded together along their outer contour 13. The sheet layers 11,

12 are provided with numerous holes 14 which act as gas inlets for the filter construction 10. In this embodiment, the pre-filter element 15 is a generally annular element, with a notch 16 for the deodorizing filter 17. In this embodiment, the deodorizing filter 17 is a disc-shaped element. The deodorizing filter 17 is contained in sheets 18, 19 impervious to gases and liquids. These sheets 18, 19 are welded or glued to the sheet layers 11, 12 that contain the entire filter construction 10, and are further welded or glued to the surfaces of the deodorizing filter 17. Therefore, the gas flowing into the Filter construction is forced to flow through the deodorizing filter from the periphery to the center. The filter construction 10 also includes a membrane 20 positioned in the central part of the deodorizing filter 17 so as to cover the gas outlet 22 from the filter construction. In this embodiment, the gas outlet 22 is surrounded by a filter flange 21, which is permanently attached to the filter construction 10 and welded to the

ES 2 602 139 T3 ostomy appliance 1. In this way, the filter construction 10 is attached to the ostomy appliance 1. The gas outlet 22 conducts deodorized gas to the outside environment through the ventilation hole 23 in the front wall 3 out of the bag. The drawing is not to scale.

Figures 2 and 3 show another example of an ostomy appliance 101. Figure 2 shows a view of the ostomy appliance 101 seen from the back side and Figure 3 shows a cross-sectional view. The ostomy appliance 101 can be provided in at least three sizes, MINI, MEDIUM, and MAXI (as shown in Figure 2). The three sizes are shown to illustrate the relative size relationship between filter construction 110 and ostomy appliance 101 for these three sizes. This example differs from the embodiment of Figure 1 in that the pre-filter element 115 includes an inspection window 125 large enough to view the stoma 6 and the area immediately around the stoma 6. The inspection window 125 is made of the same sheets 111, 112 that are used to contain the filter construction 110, which is made possible because the sheets 111, 112 in this example are transparent. Therefore, the inspection window 125 is manufactured by welding the sheets together in a circle 126 to prevent any matter from entering the filter construction and obstructing the view through the inspection window 125. It should be understood that the filter construction of the present invention may also be incorporated into bodily waste collection bags of other sizes, kinds, and shapes.

The gas inlets 114 to the filter construction are numerous and are generally located around the inspection window 125. The bottom of the pre-filter element 115 includes a recess 116 for the deodorizing filter 117. The deodorizing filter 117 is contained in lamellae 118, 119 to ensure that the gas is forced to move transversely through the deodorizing filter, from the periphery towards the center, as in the embodiment of Figure 1. Like the filter construction of Figure 1, this filter construction 110 is also provided with a membrane 120. The filter construction 110 can be permanently attached to the bag by welding a filter flange 121 to the front wall of the bag, as described with figure 1.

The filter construction 110 is further provided with foil support means 130, 131. These support means 130, 131 can be welded to the edge of the bag, and help to support and control the position of the filter construction 110.

Figure 4 shows an exploded view of the filter construction 110 of Figures 2 and 3 - however, the support means for controlling the filter construction is not shown. Filter construction 110 includes a filter flange 121, a membrane 120, a second foil layer 112 with numerous holes providing gas inlets 114, a foam pre-filter element 115 with a recess 116 for the deodorizing filter, a filter deodorizer 117 with a sheet 118 on top, a second sheet 119 such that the sheets 118, 119 together contain the deodorizing filter, and finally the first sheet layer 111, which is also provided with numerous holes by way of gas inlets 114. The placement of the holes meets the above-mentioned requirements for the hole spacings.

Figure 5 shows an ostomy appliance 201 according to the invention, in which the pre-filter element 215 in the filter construction 210 is generally banana-shaped, and is positioned over the waste inlet opening 204. The pre-filter element It comprises a first 211 and a second 212 layers of foil, which during manufacture are part of longer lengths of foil 241, 242. The two major lengths of sheet 241, 242 extend from an upper margin 243 to a lower margin 244. The upper margin 243 is located on the upper edge of the ostomy bag 201 and extends below the lower margin of the stoma construction. filter 210. Similarly, the larger sheets 241, 242 extend beyond the sides of the bag. In these larger sheets 241, 242, the filter construction 210 including the inspection window 225 is provided by welding the sheets to the inner periphery 226 of the pre-filter element (the inner curved surface of the banana shape) along the lower margins 227, 228 of the pre-filter element and on the outer periphery 229 of the pre-filter element (the outer curved side of the banana shape). Ports 245 are used to control filter construction during manufacture. When apparatus 201 is to be manufactured, this finished filter construction is attached to either the front wall or the rear wall during a separate welding process, or to the front and rear walls when the edge of the bag is welded.

They can also be used to make the embodiments of Figures 1 to 4 sheet lengths such as those shown in Figure 5.

Figure 6 shows a filter construction 310 that is provided with a drain opening 350. The drain opening 350 comprises a one-way valve 351 with two reed flaps 352, 353 that provide a one-way outlet path from the filter construction 310 . During normal use, when the filter construction is positioned with the drain opening 350 facing downward, the liquid exit debris in the filter construction 310 will travel to the drain opening 350 and out through the one-way valve 351. and they will go public. Due to the one-way function of valve 350, liquid outlet debris in the bag will be prevented from entering through valve 350 and into filter construction 310.

Figure 7 shows part of a filter construction 410, in which the deodorizing filter 417 is contained in a three-layer sheet structure 418, 410. Figure 7A shows part of the filter construction and Figure 7B shows all three layers that make up sheets 418 and 419. The three-layer sheet structure comprises a 12

ES 2 602 139 T3 outer layer 419a, an intermediate layer 419b and an inner layer 419c. The outer layer 419a (facing outward from the deodorizing filter) and the inner layer 419c (facing inwardly towards the deodorizing filter) can be made of the same material, for example EVAPE, and the intermediate layer 419b can be made of PA. As mentioned above, the laminar structure 419 oriented towards the gas outlet has to be impermeable to liquids and gases, while the laminar structure 418 does not have to be impermeable to gases because in use it is oriented towards inside in the bag. Figure 7A shows part of the filter construction 410 including the pre-filter element 415 and the sheets 411, 412 that contain the filter construction. The gas outlet 422 of the deodorizing filter may be covered by a membrane 420, as shown in the figure. The laminar structure 419 may be welded to the front wall 403 of the bag.

Figure 8 shows an ostomy appliance 501. The ostomy appliance 501 is shown in Figure 8 in the first configuration in which the pouch is neither distended nor inflated. The ostomy appliance 501 includes a filter construction 510. The filter construction has a width b that is at least 60% (preferably at least 80%) of the width B of the bag in the first configuration of the bag. . In this regard, width means the dimension in the transverse direction of the bag. Both widths are measured from the outermost limit on one side to the outermost limit transversely through the bag (or filter construction).

Figure 9 illustrates an ostomy appliance 501 shown in the second configuration, when the pouch is distended or inflated. As is clear from the figure, the width B 'of the bag in this configuration has been reduced, so that in this case it is less than the width b of the filter construction.

Figure 10 shows another filter construction 610 according to the invention. The filter construction comprises a first foil layer 611 and a second foil layer 612. A foam pre-filter 615 is contained in the foil layers. The two foil layers 611, 612 are provided with gas inlets 614 in the form of holes. Filter construction 610 also includes a deodorizing filter 617. It can be seen from the figure that the outlet debris 640 that has entered the prefilter 615 travels only a certain distance into the prefilter. Therefore, if the gas inlets 614 are located at a distance from each other greater than the maximum penetration length of the outlet debris, then the outlet debris will not be able to travel from one gas inlet to a nearby gas inlet.

Figure 11 shows a schematic drawing of the filter tester 1000 used in the example mentioned above. The filter tester 1000 comprises a flow controller 1001 to measure the flow through the filter construction and a differential pressure meter 1002 to measure the pressure in the ostomy bag. Such flow controller and pressure meter are well known in the art. The filter testing unit 1003 is a control unit that can apply controlled handling and shaking of an ostomy bag. During the test, the ostomy bag (not shown) is held in the ostomy bag holder 1004, which comprises a support plate 1005, 1006 on each side of the bag. Filter testing unit 1003 controls that a handling plate 1007 applies controlled bag handling.

Figures 12 and 13 show the results of the series of tests 1. Figure 12 shows the results of the test on colostomy bags -corresponding to the series of tests 1.1 described above- and Figure 13 shows the results of the test on bags of ileostomy - corresponding to test series 1.2 described above. The difference between the ostomy bags according to the invention and the ostomy bags provided with standard filters (described above) is obvious. In both figures, the dotted lines show the results of the test of ostomy bags according to the invention, and the dashed lines (left in the figures) show the results of the tests of ostomy bags with standard filters. The solid lines between the dotted lines and the dashed lines show the average values. In figure 13 only the average line for the standard filter is visible, because all the filters lasted only 1 cycle. Thus, for colostomy bags, it is shown in Figure 12 that an ostomy bag according to the invention lasts an average of 13 contamination cycles before the flow through the bag is below an acceptable level. This should be compared to the average value for an ostomy bag with a standard filter, which lasts only 1 to 2 cycles. For ileostomy bags, Figure 13 shows that an average ostomy bag according to the invention lasts 12 cycles. An average ostomy bag with a standard filter lasts only 1 cycle.

Figure 14 shows the test results for the previous series 2 tests. Figure 14 shows that using holes only 1mm in diameter (the dashed line) has a negative influence on ileostomy bags. The flow decreases faster and the bags last less than the bags with 2mm holes (the solid line).