ostomy accessory, and methods of reducing the number of strains and increasing the time before the s

专利摘要:
OSTOMY ACCESSORY AND METHODS OF REDUCING THE NUMBER OF DISTENSIONS AND INCREASING THE TIME BEFORE THE DISTENSION OCCURS IN AN OSTOMY ACCESSORY. It is an ostomy accessory comprising a pouch and a filter construction. The filter construction has a first and second layer of foil to provide a wrap for the elements in the filter construction. The filter construction is fixed inside the bag, so that the filter construction is suspended inside the bag. The two layers of metallized foil can generally be parallel to the walls of the ostomy bag. The layers of metallized foil are provided with numerous holes that act as gas inlets for filter construction. The filter construction includes a pre-filter element and a deodorizing filter. A discharge collection method, as well as an ostomy accessory, is provided. A method of reducing the number of strains and an ostomy accessory is also provided to reduce the number of strains. A method of increasing the time for strains is also provided, as well as an ostomy accessory to increase the strain time.
公开号:BR112012030178B1
申请号:R112012030178-0
申请日:2011-06-01
公开日:2020-07-28
发明作者:Lars Olav Schertiger；Jan Torstensen；Preben Luther
申请人:Coloplast A/S；
IPC主号:

专利说明:

[001] The invention relates to an ostomy accessory that has a filter construction confined to two metallized sheets, a first metallized sheet and a second metallized sheet. The filter construction is provided with holes in at least one of the layers of metallized foil and the holes function as gas inlets. The invention also relates to a method of collecting a stoma discharge, a method for reducing the number of strains and a method of increasing the time before the strain occurs. Finally, the invention relates to an ostomy accessory for use in a discharge collection method, an ostomy accessory to reduce the number of strains and an ostomy accessory to increase the time before the strain occurs. Background
[002] In connection with surgery for numerous 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 on the abdominal wall for the discharge of visceral contents. The discharge of visceral contents, including intestinal gases, cannot be regulated according to the will. For this purpose, the user will have to have an accessory to collect the material that emerges from such an opening in a bag, which is then emptied and / or discarded at an appropriate time.
[003] The discharge of flatus, measured in volume, can exceed the discharge of solid and liquid fecal matter by hundreds in percentage and, therefore, there is usually a need for continuous or frequent ventilation of the intestine or collection of the bag. Normally, the flatus emanating is deodorized with a suitable filter. Commonly, the active filter is powdered active carbon, which absorbs HoS being the main component of the flatus smell.
[004] During the use of a collection bag, the exit of a colostomy or an ileostomy can adhere to the face of the filter that faces inwards in the collection bag. This will eventually lead to clogging of the filter, thereby reducing the flow through the filter. When the filter is completely blocked, it will stop working and the bag will be filled with gases and will expand, an effect also known as distension. This can cause embarrassment to the user, since the bag will be visible through the clothes. This can also cause the attachment to separate from the user's skin - or the wafer bag to separate. Summary of the Invention
[005] The invention relates to an ostomy accessory with a filter construction. The ostomy accessory pouch has a front wall and a rear wall. The filter construction has a first and second metallized sheets that provide a wrap for the elements in the filter construction. The filter construction can be fixed inside the bag bag such that, in use, the filter construction is substantially suspended in the bag, meaning that the filter construction has the ability to follow the movements of the bag and, in addition, it has the ability to disintegrate and curl during use. The holes are provided in at least one of the first or second metallized sheets in order to provide gas inlets for filter construction. Such an ostomy accessory will have, in use, the ability to evacuate excess gas through the filter at any time, due to the fact that the provision of the suspended filter construction ensures that at least one inlet is always open. Brief Description of Drawings
[006] Figure 1 illustrates a modality of an ostomy accessory according to the invention.
[007] Figures 2 and 3 illustrate another modality of an ostomy accessory according to the invention.
[008] Figure 4 illustrates an exploded view of the filter construction of the modality in Figures 2 and 3.
[009] Figure 5 illustrates yet another modality of an ostomy accessory according to the invention.
[0010] Figure 6 illustrates a modality of a filter construction provided with a drain opening.
[0011] Figure 7 illustrates a modality of the deodorizing filter confined in a structure of three layers of metallized sheet.
[0012] Figure 8 illustrates an embodiment of an ostomy accessory according to the invention. In Figure 1, the bag is illustrated in the first configuration.
[0013] Figure 9 illustrates the same modality of the ostomy accessory according to the invention; however, in Figure 9, the accessory is illustrated in the second configuration.
[0014] Figure 10 illustrates a filter construction for use in an ostomy accessory according to the invention.
[0015] Figure 11 illustrates a test configuration used to test ostomy accessory bags according to the invention.
[0016] Figures 12 to 14 illustrate results of tests of ostomy accessories according to the invention. Detailed Description of the Invention
[0017] In a first aspect, the invention relates to an ostomy accessory comprising - a pouch comprising at least one vent opening to allow gas to escape from the bag - a filter construction comprising a first layer of metallized sheet and a second layer of metallized sheet defining a wrap, the wrap including a pre-filter element o at least one gas inlet is provided in at least one of the first and / or second sheet layers metallized and at least one gas outlet is provided in the second layer of metallized foil where the second layer of metallized foil of the filter construction is attached to the front or back wall of the bag, so that the gas outlet of the filter construction communicates with the bag vent opening, and where the attachment is such that a main part of the filter construction is left suspended in the bag.
[0018] An ostomy accessory with a filter construction as described above will have excellent properties to prevent or at least reduce strain, due to the fact that the filter construction is suspended in the bag.
[0019] Suspension is understood to mean that the filter construction has the ability to follow the movements of the bag in a substantially unimpeded manner. The filter construction can be attached only to the area immediately surrounding the breather opening leaving most (if not all) of the envelope outline separate from the ostomy accessory. Alternatively or additionally, the filter construction is fixed at different points across the surface of the second metallized sheet. This means that in one embodiment, a major part of the filter construction has the ability to disintegrate and curl during use, thereby preventing the filter construction from sticking to the pouch walls and thereby maintaining at least some gas inlets open at all times. It is understood by disintegrating and rolling up that the filter construction obtains a wavy shape in the plane of the bag.
[0020] In another embodiment, the filter suspension is such that the filter construction is fixed in balance in the bag.
[0021] A main part of the filter construction is understood to mean that the surface area of the part of the filter construction that is fixed is significantly less than the remaining surface area of the filter construction. For example, the fixed area can make up less than 20% of the surface area of the filter construction, such as 10% or 5% or even as little as 1%.
[0022] An ostomy accessory is well known in the art. This normally comprises a pouch that has a front wall and a back wall of metallized sheet material impermeable to gas or liquid (for example, polyethylene (PE), polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA)) that it is welded or glued around the edges or the rim, in order to form a bag that defines a refuse collection chamber. The pouch can be welded or glued only partially around the rim, so that an opening for emptying is provided at the bottom of the pouch. In that case, the bag may be provided with means to close that opening. The bag usually includes a refuse opening that, on the outside, is provided with a mechanical coupling means or adhesive to attach to a side of the wafer body with a non-harmful skin adhesive adapted to adhere directly to the abdomen of the user.
[0023] Usually, the refuse inlet opening is placed in the upper part of the ostomy pouch, such that when a user gets up, the refuse inlet opening will be above the midline of the ostomy pouch. This leaves a larger collection volume below the waste inlet opening. In this way, the top of the ostomy accessory and the pouch is defined as the part closest to the refuse opening, and the bottom is defined as the opposite part. The longitudinal direction of the ostomy accessory and the pouch is defined as the direction from top to bottom. The transverse direction of the ostomy accessory, the pouch and the filter construction positioned in the pouch is defined as the direction in the pouch plane perpendicular to the longitudinal direction. The axial direction is defined as the direction of the stoma.
[0024] The filter construction comprises a first and second layers of metallized foil that define a wrap for the filter construction. The first and second layers of metallized sheet can be laminated to the surface of the elements (for example, the pre-filter) in the filter construction. Laminates are understood to mean that the foils are attached to the entire surface, so that there is no space between the elements and the foil layers. Metallized sheets can be fixed by gluing or heat sealing. When the first and second layers of metallized sheet are laminated to the surface of the elements, the layers of metallized sheet are not necessarily attached to each other along their contour. If the layers of metallized sheet are separated in their outline or, at least partially separated along their outline, the separate parts will also define gas inlets for the filter construction.
[0025] Alternatively, the first and second layers of metallized foil can be attached to each other along their total contour, in order to define a wrap. In this case, the pre-filter element can, during manufacture, be compressed smoothly in the transverse direction of the filter construction. The compression of the prefilter element ensures that there is no distance between the foil and the prefilter element, thereby smoothing the risk that the liquid or semi-solid parts of the outlet will overtake the prefilter element. In this way, it is guaranteed that the liquid material entering the filter construction will flow through the pre-filter element.
[0026] The layers of metallized sheet can be attached to each other by means of welding, which is a quick process to use in manufacturing. The metallized sheet alone can thus be weldable. Metallized sheets can also be attached to each other by a bonding process, for example, using acrylate and / or hot melt adhesive. In addition, the metallized sheet may be impermeable to gas and liquid. A material such as PE foil would be suitable for use. Alternatively, the foil may be non-woven or textile. However, it must be ensured that the liquid or semi-solid part of the outlet travels at least some distance through the pre-filter element before reaching the deodorizing element. Therefore, the metallized sheets that immediately surround the deodorizing element must be impermeable to gas and liquid. In one embodiment, metallized sheets impermeable to gas and liquid can be supplied at a distance of at least 3 cm from the deodorizing element. In another embodiment, the metallized sheets impermeable to gas and liquid can be supplied at a distance of only 15 mm from the deodorizing element. This depends on the type of outlet on the exchange, as described below.
[0027] In one embodiment, the filter construction includes a deodorizing filter inside the wrap. Alternatively, the deodorizing filter can be positioned on the outer surface of the bag, so that it communicates with the vent opening in the bag. The deodorizing filter can also be positioned inside the bag that communicates with the vent opening, but outside the wrap communicating with the gas outlet.
[0028] The deodorizing filter can be supplied as filter packs typically used for ostomy bags. Typically, the deodorizing filter will have a layer of metallized foil laminated on 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 intended gas flow direction of the deodorizing filter. Thus, adequate deodorization is achieved. The filter construction may include more than one deodorizing filter, such as two or three. The number of vent openings in the bag must match the number of deodorizing filters in the filter construction. As an example, a filter pack that has a shape and flow path like Coloplast A / S Filtrodor® can be used. This filter package comprises a disk-shaped foam element where the foam is impregnated with carbon. The foam element is covered with a metallic foil impermeable to gas on both sides of the disc, except for a hole drilled centrally in one of the foil. This orifice acts as a gas outlet for the deodorizing filter and the element's periphery functions as a gas inlet. The direction of gas flow through the deodorizing filter can also be opposite, so that the gas enters the deodorizing filter centrally and exits at the periphery. When the gas travels the distance from the disc's periphery to the center (or vice versa), it is properly deodorized. The diameter of such an element can be approximately 20 to 25 mm, but it can be larger or smaller depending on the deodorizing capacity.
[0029] The deodorizing filter can also have an elongated shape with an inlet at one end and an outlet at the other. This deodorizing filter can be of the type described in European patent no. EP0235928B1.
[0030] The deodorizing filter could be a porous material loaded with carbon such as foam, felt, nonwoven or similar, or the activated carbon could be based on a carbonized material such as, for example, carbonized viscose or similar. Carbon could be either not activated or activated through the application that catalyzes compounds such as copper oxide, chromium oxide, potassium permanganate or other catalyst compounds.
[0031] In a preferred embodiment, at least one of the first and / or second layers of metallized sheet has holes with a diameter of approximately 0.1 to 2.0 mm. Both layers of metallized foil can also be provided with holes. These holes act as gas inlets to allow gas to enter the filter construction. The small size of the orifices helps to prevent semi-solid material and, to a certain degree, liquid material, from entering the filter construction, but allows the gas to enter.
[0032] The holes in both layers of metallized foil minimize the risk of all entrances being covered by the stoma outlet - even if the outlet is to be placed close to the filter construction in the bag. The position of the exit depends on the user's movement (lying or sitting) and the type of exit. The outlet will typically sit at least close to the back wall of the ostomy bag. In this case, the holes in the metallized sheet facing the front wall will be accessible to the gas. The outlet can also sit close to the front wall, in which case the holes in the metallized sheet facing the back wall will be accessible to gas.
[0033] The holes can be made by drilling, burning and engraving or by using a laser, drill, needle or male for the drill bit. The number of holes can be anywhere from 1 hole for an ileostomy bag to more than 150 holes for a colostomy bag. The number of holes depends on the size of the filter construction and the type of outlet that comes out of the stoma.
[0034] The filter construction of this invention is contemplated for being used in connection with an ileostomy, as well as a colostomy. Both types of starlings typically deliver different types of output. For an ileostomy, an outlet is typically thinner and syrupy, while the outlet of a colostomy is typically more like porridge. However, the type of outlet may also depend on the intake of food and liquids - therefore, reference will be made below to the thin outlet (syrupy to liquid) and thicker outlet (such as porridge) regardless of whether it comes from an ileostomy or a colostomy .
[0035] For the thicker outlet, there is a risk that the holes, which act as gas inlets, are blocked due to the diffusion of the outlet through the holes. Due to the fact that the outlet has a relatively thick consistency, it may not be able to escape completely through the hole. Therefore, the orifice can be charged with an outlet and thus stop functioning as a gas inlet. For the thin outlet, the holes will not be loaded with the outlet and thus obstructed, due to the fact that the outlet is able to pass through the holes. Therefore, a larger number of holes (gas inlets) is required for the thick outlet than for the thin outlet. For the fine outlet, the number of holes (gas inlets) can be 2 or just 1 hole (gas inlet), while for the thick outlet up to 150 holes (gas inlets) can be used. At least more than 50 holes (gas inlets) can be used for the thick outlet.
[0036] Not only the number of holes, but also the size of the holes may depend on the type of outlet. This is due to the fact that it is unlikely that the thick outlet will be able to pass through an orifice (gas inlet), as these orifices are typically below 2 mm in diameter. On the other hand, a small orifice is unlikely to be able to stop the fine outlet. Therefore, for the fine outlet, few and larger orifices (gas inlets) are preferred, and for the thick outlet, many small holes (gas inlets) are preferred.
[0037] When the size of the holes is given as a diameter size, the reference is for a larger diameter of the hole, in case the hole is not circular, but elliptical. If the hole is more angular, then the reference is again to a larger "diameter" which, in this case, may be the longest diagonal dimension through the hole.
[0038] In an embodiment of the invention, a first distance between two neighboring orifices is such that the liquid cannot travel from one orifice to the neighboring orifice within the time of normal use. In a related embodiment, a second distance from the deodorizing element to the nearest gas inlet is such that the liquid cannot travel from the nearest gas inlet to the deodorizing element within the time of normal use.
[0039] 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 will be in the flat direction of the filter construction. Thus, the second distance is defined as the distance in one direction in the plane of the metallized sheets of the filter construction from the gas inlet closest to the deodorizing filter to the edge of the deodorizing filter closest to the same gas inlet. The flat direction is defined by the foil layers of the filter construction, so that each foil extends in the flat direction.
[0040] For the thick outlet, it is contemplated that the obstruction of the filter construction occurs when all gas inlets are blocked by the outlet. The gas inlets can be blocked by semi-solid material through the orifice, thereby closing the orifice. The first distance between neighboring holes and the second distance from the gas inlets to the deodorizing element ensure that the outlet that blocks a hole will not be able to travel through the pre-filter material along the surface of the foil and into the next hole or for the deodorant element, closing it too. The liquid and semi-solid material that enters the deodorant element can leave this element deprived of its ability to deodorize flatus gas. Tests show that if the first distance between two gas inlets or the second distance from a gas inlet to the deodorizing element is greater than 10 mm in the flat direction, then the semi-solid or liquid material will not be able to travel through the material of pre-filter within the time of normal use. Similarly, these distances minimize the risk that diffusion through the surface of the filter construction will cover many of the gas inlets.
[0041] The second distance is in a mode of at least 5 mm. Only a small amount of liquid will be able to enter the pre-filter element, due to the small holes in the metallized sheets of the filter construction, so only a short distance is required to be able to stop that liquid. However, the second distance can also be approximately 3 cm. Again, there is a difference between the thin and thick outlet. The thick outlet will not be able to travel very far in the pre-filter element, so the second distance between the gas inlets and the deodorizing filter can preferably be smaller, for example, as small as 5 mm . In one embodiment, the shortest distance between the deodorizing element and a gas inlet is greater than 15 mm. In this way, it is guaranteed that no liquid or semi-solid material will reach the deodorizing element during the time of normal use.
[0042] However, the thin outlet will have the ability to travel a longer distance through the pre-filter element, so the second distance between the gas inlets and the deodorizing filter must be greater, for example, at least 3 cm.
[0043] A third distance between gas inlets and the rim of the filter construction can be greater than 5 mm. When the gas inlets are close to the rim of the filter construction, there is no neighboring hole in the direction of the rim. Therefore, the distance may be less here.
[0044] The foil wrap that defines the filter construction can be provided with a drain opening facing downwards in the ostomy bag - that is, it faces the bottom of the ostomy bag. This bottom facing the drain opening provides an opportunity for, in particular, the fine outlet to be drained out of the filter construction. The opening can be provided with a one-way valve, so that the outlet in the bag is prevented from entering the filter construction through that opening. A one-way valve is well known in the art and can, for example, be provided as the foil valve.
[0045] In one embodiment, the filter construction additionally includes a flange that surrounds the gas outlet. The filter flange can be an injection molded flange. This filter flange serves the purpose of providing an element for welding the filter construction to the ostomy bag. In this way, the positioning of the filter construction is independent of the production of the ostomy bag and can be done during the production of the ostomy bag or at any later time. In addition, the filter flange is made of a material that is substantially non-conductive and capable of absorbing heat. Then, the heat from the welding process is not transferred to the filter construction. Thus, the filter construction can be manufactured as a finishing element, including the pre-filter element and the deodorizing filter, and subsequently welded to the bag without running the risk that the foil and the pre-filter element are soldiers to each other.
[0046] The filter flange can be made of a material such as PE or EVA, which are capable of being quickly welded to the ostomy bag. Welding can be carried out, for example, at 160 ° C for approximately Yi second. The flange thickness must be above approximately 0.5 mm in order to absorb the heat from the welding, in order to prevent the metal sheets and the pre-filter element from being welded together. The upper limit for thickness is controlled by requesting a separate bag - so it must be below approximately 1 mm.
[0047] The filter flange can be glued to the bag, instead of soldered to it. This can be done using an acrylate or hot melt adhesive.
[0048] The filter construction can also be directly welded to the ostomy bag, meaning that the filter flange can be omitted. In this case, the deodorizing filter is directly soldered to the bag, that is, the metallized sheet that covers the deodorizing filter is soldered to the front or rear wall of the ostomy bag.
[0049] The metallized sheets covering the deodorizing filter can, in one embodiment of the invention, be made of a three-layer structure of laminated metallized sheet on the deodorizing filter. In this case, the metallized sheets can be made of metallized sheets with a liquid-impermeable and gas-impermeable barrier, so that gas and liquid are prevented from leaving the filter in any other position than the defined gas outlet. The three-layer structure can be made of an outer layer of metallized foil, which is adapted to be welded to the metallized foil bag, an intermediate layer of metallized foil adapted to function as an intermediate protective layer and an inner layer of metallized foil adapted to be laminated to the deodorizing filter. The intermediate layer protects the metallized sheet structure from the occurrence of small holes through the layers. Protective capacity is provided by ensuring that the intermediate layer of metallized foil has a melting temperature significantly higher than the outer and inner metallized foil layers. For example, the outer and inner metallized sheet layers can have a melting temperature between 80 ° C and 150 ° C and the intermediate layer can, in that situation, have a melting temperature above 200 ° C. As an example, the outer and inner layer can be made of a copolymer of ethylene vinyl acetate (EVA) and polyethylene (EVAPE) and the intermediate layer can be made of polyamide (PA).
[0050] A three-layer structure, as described, can be welded or laminated on the side of the deodorizing filter that faces outwards when positioned in the ostomy bag. On the side facing the inside of the bag, it is less important to avoid small holes and gas impermeability, since the leakage of gas through the foil will only enter the ostomy bag again. However, the three-layer metallized sheet structure can, however, be used on the inside as well, thus avoiding the need to use separate metallized sheets. In any case, gas leakage towards the outside should be avoided.
[0051] When layers of metallized foil, as described above, are used as cover layers for the deodorizing filter, this filter can, in itself, serve as a thermally absorbable flange, due to the fact that the deodorizing filter is able to absorb the heat from the welding process.
[0052] The pre-filter element can be made of a 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 the pore size, although it actually refers to the number of pores per inch in the foam material. Felt, fluff, nonwoven or any other porous material can also be used. The gas (including solid and / or semi-solid waste material) will enter the pre-filter element through the holes in the foil layers that provide the gas inlets for the filter construction. Due to the tortuous 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.
[0053] The thickness of the pre-filter element can be between 1 and 5 mm as approximately 2 or 3 mm. The thickness is defined as the dimension in the direction by constructing a filter corresponding to the dimension of the pre-filter element in the direction of the first layer of metallized sheet towards the second layer of metallized sheet.
[0054] 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, a space must be left for manufacturing tolerances. The area of the pre-filter element can be as small as 10% of the area of the front or rear wall when taken in the plane of the bag. This will be the case if a large bag is used, for example, a max bag. In another embodiment, an 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 particularly true for small bags, for example, a mini bag.
[0055] A large prefilter element can be advantageous for bags loaded with fine outlet, due to the fact that it is difficult to completely prevent the fine outlet from entering the prefilter element. Thus, a large volume of foam is necessary to prevent the fine outlet from reaching the deodorizing filter. A large prefilter element can also be advantageous for bags loaded with a thicker outlet, due to the fact that a large number of gas inlets are required to ensure that at least some gas inlets are opened. As mentioned earlier, when the thick outlet is present in the bag, the gas inlets will be blocked due to the diffusion of the outlet through the inlet holes. Thus, a large area of metallized foil with gas inlets is necessary when the bag is loaded with a thick outlet.
[0056] The gas outlet of the filter construction communicates with the vent opening in the form of a hole or crack in the ostomy bag, so that the gas coming out of the gas outlet enters through the vent opening and out of the environment or through the deodorizing filter, if it is positioned on the outside of the bag. Communication can be carried out by positioning the gas outlet in alignment with the vent opening or at least in the vicinity of the vent opening. The vent opening must be confined, for example, by a weld that surrounds the vent opening, such that the gas in the bag is prevented from leaving the vent opening without going through the filter construction. This can typically be ensured by welding the filter construction for the ostomy pouch in an uninterrupted weld, so that the gas outlet and the vent opening rest within the weld limits.
[0057] In one embodiment of the invention, the filter construction additionally includes a membrane positioned at the gas outlet. This membrane is permeable to gas, but impervious to moisture. The membrane can be microporous and hydrophobic and made of a material like Goretex® or Tyvek®. The membrane must be capable of providing a flow between 100 to 550 ml / min at a pressure difference of 1 kPa (0.01 bar), for example, 250 ml / min or 350 m] / min.
[0058] The membrane can be fixed, for example, adhered to the surface of the deodorizing filter, that is, between the surface of the deodorizing filter and the "internal" surface of the second metallized sheet. Alternatively, the membrane is positioned on the outside of the second metallized sheet - that is, it is between the gas outlet and the vent opening in the bag.
[0059] The metallized sheet layers of the filter construction can confine the pre-filter element, the deodorizing filter and the membrane.
[0060] In one embodiment, where the wrap includes the deodorizing filter, the pre-filter element comprises a cutout for the deodorizing filter. The cutout can be disc shaped to be compatible with a disc shaped deodorant filter. The gas inlets are placed close to the periphery of the filter construction and the deodorizing filter has its gas inlet along its periphery and an outlet placed substantially centrally.
[0061] The pre-filter element can be supplied as an annular foam element. This may have a circular or angular outer periphery. A part (e.g., the central part) of the pre-filter element is removed by drilling or cutting a cutout in the pre-filter element, thereby leaving a space for the deodorizing filter. Preferably, the cutout for the deodorizing filter is substantially compatible with the outer contour of the deodorizing filter. If the deodorizing filter is shaped like a disk, then the cutout for the deodorizing filter is usually shaped like a disk, and if the deodorizing filter is shaped like a banana or angled, the cutout for the deodorizing filter will generally have that shape. The cutout compatibility between the deodorizing filter and the deodorizing filter provides a more compact structure. The gas entering the filter construction through the gas inlets on the periphery will travel through the pre-filter element towards the inner periphery of the pre-filter element and from there to the deodorizing filter. Then, the gas will cross the deodorizing filter and leave the filter construction at the opening in one of the layers of metallized foil, providing the gas outlet.
[0062] Such a filter construction will be compact and easy to position anywhere in the ostomy bag according to the need or configuration of the production.
[0063] In one embodiment, the pre-filter element is positioned close to the deodorizing filter, so that they are positioned juxtaposed to each other within the filter construction. In this construction, the deodorizing filter will be positioned at one end of the filter construction. The pre-filter and the deodorizing element can, in other words, be positioned sequentially. The filter construction can then be elongated and, preferably, slightly 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 positioned on the same plane. Alternatively, the deodorizing filter is positioned on top of the pre-filter element.
[0064] One modality of the invention refers to the construction of a filter that incorporates an inspection window, allowing the user to visually access the stoma and possibly also the peristomal area.
[0065] This inspection window can be provided in the pre-filter element, so that the pre-filter element is a generally disk-shaped element that has a circular hole * with a diameter of at least the diameter of the opening. refuse inlet, where the metallized sheet layers of the filter construction are welded along the periphery of the circular hole in the pre-filter element.
[0066] To provide a transparent inspection window, one of the layers of metallized sheet must be transparent or must be removed in the circular hole.
[0067] In a related mode, the inspection window is placed off-center in the pre-filter element and the deodorizing filter is placed in a cutout for the deodorizing filter.
[0068] The inspection window can be placed in such a way that it leaves a thin strip of pre-filter element above the waste inlet opening and a larger area with the cutout for the deodorizing filter below the waste inlet opening. In this way, the deodorizing filter will be placed below the waste inlet opening. However, the inspection window can also be placed in such a way that a thin strip of the pre-filter element is below the waste inlet opening and the larger area including the cut-out for the deodorizing filter and the deodorizing filter is placed above opening of the refuse inlet.
[0069] The stoma inspection window allows a user to inspect the stoma and the peristomal area from the outside of the ostomy accessory. This requires that part of the front wall of the bag be transparent. The diameters of the individual parts can be as follows in a specific modality: the deodorizing filter, 30 mm, the pre-filter element, 110 mm and the inspection window on the pre-filter element, 70 mm.
[0070] In another modality, the inspection window can be provided, since the pre-filter element is shaped like a banana and positioned above the and, therefore, not in a view of the stoma. The pre-filter element can be placed above and partially around the waste inlet opening. This pre-filter element can have a circular hole in the middle of the banana shape to provide space for the deodorizing filter.
[0071] One embodiment of the invention relates to the provision of a filter flap as described in European patent EP1578308B1 on an ostomy accessory according to that invention. In this way, it is guaranteed that the flow through the filter construction of this invention must be very high, so that the front and rear walls of the bag start to collapse in relation to each other, resulting in plating, so it is possible to close partially or completely the vent opening of the bag with the flap described in the patent.
[0072] In a second aspect, the invention relates to an ostomy accessory comprising -a pouch that includes a front wall and a rear wall, -a refuse opening in the rear wall to let the stoma exit between in the bag, -at least one vent opening to let the gas escape the bag, -a filter construction comprising a first and second layer of metallized foil that define a wrap, -the filter construction is fixed inside the bag, so that each of the layers of metallized sheet is substantially parallel to the front and rear wall of the bag, the first layer of metallized sheet faces the rear wall and the second layer of metallized sheet faces the front wall of the bag , -when the filter construction is provided with gas inlets in at least one of the layers of metallized sheet, and a gas outlet placed in the second metallized sheet adapted to communicate with the opening breather, -whether the wrap includes a pre-filter element.
[0073] An ostomy accessory with a filter construction, as described above, will be able to evacuate gas from the bag at all times. The provision of gas inlets in one or both layers of metallized foil provides trajectories through the pre-filter at all times.
[0074] Additionally, the position of the metallized sheets parallel to the front and rear wall helps to minimize the risk of covering the gas inlets with outlet during use.
[0075] In one embodiment, an ostomy accessory according to the second aspect of the invention includes a deodorizing filter positioned inside the wrap, such that the gas that leaves the pre-filter element enters directly into the deodorizing filter and from give out through the gas outlet. A gas flow direction is defined as the direction in which the gas flows from the gas inlets through the pre-filter element, through the deodorizing filter and out through the gas outlet and vent.
[0076] In an ostomy bag according to the second aspect of the invention, the filter construction may comprise one or more means of transport attached to the metallized sheets of the bag at the time of the contour welding process step.
[0077] The means of transport may have separate or integral parts of one or both layers of metallized sheet of the filter construction; if separated, they can be attached to the metallized sheet layer (s) by welding or gluing. The means of transport can fix the filter construction to the contour of the ostomy bag on top of it, so that during use, gravity helps to force the filter construction down into the bag and keep it in a desired position . The means of transport can also fix the filter construction in a lower position, if desired.
[0078] The filter construction will then be prevented from being broken inside the bag during use. To some extent, the filter construction will still be able to disintegrate during use. This is due to the fact that the means of transport only attach the upper part of the filter construction to the ostomy bag. Thus, the bottom of the filter construction can still remain suspended.
[0079] In a third aspect of the invention, the invention relates to an ostomy accessory comprising - a pouch comprising a front wall and a rear wall or a refuse opening in the rear wall to allow the outlet of the stools enter at least one vent opening in the bag to allow gas to escape from the bag - a filter construction attached to the ostomy bag and comprising a first layer of metallized foil and second layer of metallized foil that define a wrap, being that the casing includes a pre-filter element o multiple gas inlets are provided in at least one of the first and / or second layers of metallized foil o one gas outlet is provided in the second layer of metallized foil, wherein the filter construction is adapted to disintegrate when the bag is loaded.
[0080] An ostomy accessory with a filter construction, as described above, will be able to evacuate gas in the bag at all times. The positioning of the gas inlets on the metallized sheet layer (s) of the filter construction and the ability of the filter construction to disintegrate ensure that at least one inlet is open at all times, particularly when the bag is loaded or when the bag is distended. When the bag is full, the bag will change shape to a more inflated longitudinal configuration. This means that the bottom of the bag can move smoothly downwards due to the load on the bag and, at the same time or alternatively, the bag can become thicker in the axial direction (outwards in the direction of the stoma). This leads to a reduction in the width direction and will lead to the disintegration of the filter construction.
[0081] In an embodiment of the invention according to the first, second and third aspects, the filter construction disintegrates when the bag is loaded as a result of the relationship between the width of the filter construction and the width of the bag in the transverse direction .
[0082] By adapting the width of the filter construction in the transverse direction to the width of the bag in the transverse direction, it is possible to get the filter construction to disintegrate when the bag is loaded. During use, the bag configuration moves between two extreme configurations: -a first configuration in which the bag is neither inflated nor inflated -a second configuration in which the bag is distended and / or inflated.
[0083] During the loading of the bag and as long as the filter is able to handle the amount of gas, the bag can adopt any configuration between the first and second configuration.
[0084] This means that in the first bag configuration, the bag width is substantially unchanged when compared to the original width of a new, unused bag. In the second bag configuration, the bag width is reduced compared to the original width of a new, unused bag.
[0085] In an embodiment of the invention according to the first, second or third aspect, the filter construction has a width in the transverse direction that is at least 100%, at least 80% or at least 60% of the bag width in the transverse direction.
[0086] The width of the filter construction is intended to be the largest width through the construction of the filter in the transverse direction in the plane of the metallized sheet layers. Similarly, the width of the bag is the largest width across the bag in the transverse direction, in the plane of the walls of the bag.
[0087] When the filter construction has a width corresponding to the bag - and the filter construction enters the bag - then, the filter construction will obtain a wavy or slightly curved shape as soon as it enters the bag. This will help to provide access to the gas inlet (s) positioned across the surface of the filter construction.
[0088] It is contemplated that, in the second configuration of the bag, the width of the bag is reduced. By providing a width of at least 80% of the bag width, a filter construction that can be easily assembled within the bag is obtained, due to the fact that the difference in width leaves a space for fixing the filter construction to the front wall or rear of the bag and then subsequently fixing the front or rear wall to the remaining wall along its rim by any known means. Thus, the 80% percentage provides manufacturing tolerances for the filter and bag construction, while still providing a filter that is capable of curling when the bag is loaded or extended, due to the fact that the bag width is reduced to below 80% of the original width of a new, unused bag.
[0089] By providing a width of at least 60% of the bag width, the same effect as above is achieved - leaving a slightly larger space for manufacturing tolerances and providing a filter construction that will require at least greater load or strain in the bag before being able to curl up.
[0090] For the second and third aspects of the invention, all other parts of the ostomy accessory and filter construction can be as described in the first aspect of the invention above. For example, an ostomy accessory according to the second or third aspect of the invention may also include a deodorizing filter positioned inside the wrap, outside the pouch or between the wrap and the pouch wall. Similarly, an ostomy accessory according to the second or third aspect can also include orifices that function as gas inlets of approximately 0.1 to 2.0 mm in diameter and a number of, for example, 2 for one ileostomy bag up to more than 150 for a colostomy bag. Likewise, in an ostomy accessory according to the second or third aspect of the invention, the ostomy accessory itself, the distance between the gas inlets and between the gas inlets and deodorizing filter, the filter flange, the welding of the filter construction to the wall of the bag, the pre-filter element, the deodorizing filter, the gas outlet and vent, the membrane, the provision of the different parts of the filter construction which includes their mutual position and the inspection window can provided as described above.
[0091] A particularly interesting embodiment of the invention relates to an ostomy accessory according to the first second or third aspect and -in which the gas inlets have a diameter of at least 1 mm as approximately 2 mm and -in that the area of the pre-filter element is greater than 40% of the area of the rear wall.
[0092] This ostomy accessory is particularly useful for use with an ileostomy, due to the fact that it has few large holes and a large area of pre-filter element. Thus, it uses the fact that it is not possible to prevent the fine outlet from entering the pre-filter, but the pre-filter element is large enough to be able to contain it during the normal wear time for plastic bags. ileostomy. The large orifices make it (almost) impossible for the fine outlet of an ileostomy to obstruct the orifices by diffusing the outlet along them.
[0093] When providing an area of the pre-filter element greater than 40% of the area of the back wall, an adequate amount of porous material will be present even if the porous material is only 5 mm thick. This still leaves an adequate volume of porous material, so that the pre-filter element is able to handle the amount of liquid entering the pre-filter element.
[0094] Another interesting embodiment of the invention relates to an ostomy accessory according to the first, second or third aspect and - in which the number of gas inlets is greater than 50 and supplied in both the first and the second metallized sheet, -in which the gas inlets comprise holes which have a diameter below 1 mm, such as approximately 0.5 mm, as well as holes which have a diameter of approximately 1 mm or more, such as approximately 2 mm.
[0095] This ostomy accessory is particularly useful for use with a colostomy, due to the fact that most of the outlet coming out of a colostomy is quite thick and then, as described above, the filter construction will be obstructed due to the fact that the outlet is diffused over the surface of the filter construction - therefore, the number of holes must be large and these must be positioned on both metallized sheets, in order to prevent all of these being obstructed. Additionally, the outlet coming out of a colostomy can comprise a thinner outlet as well - so it is advantageous if the diameter of the gas inlets varies.
[0096] In a fourth aspect of the invention, the invention relates to a method of collecting ostomy discharge on an ostomy accessory comprising a pouch and a filter construction comprising a first layer of foil and a second layer of foil that define a wrap, the wrap including a pre-filter element, where multiple gas inlets are provided in at least one of the foil layers, a gas outlet is provided in the second foil layer, the filter construction is fixed inside the bag, so that a main part of the filter construction is left suspended in the bag, and the method comprises placing the accessory around the stoma.
[0097] In one embodiment, the bag is provided with a vent opening and the filter construction is positioned in such a way that the gas outlet of the filter construction communicates with the vent opening of the bag.
[0098] A fifth aspect refers to an ostomy accessory comprising a pouch and a filter construction, comprising a first layer of metallized sheet and a second layer of metallized sheet that define a wrap, the wrap including an element pre-filter, where multiple gas inlets are provided in at least one of the layers of metallized foil, a gas outlet is provided in the second layer of metallized foil, the filter construction is fixed inside the bag in such a way that a main part of the filter construction is left suspended in the bag, for use in an ostomy discharge collection method, the method comprising placing the accessory around the stoma.
[0099] In one embodiment, the bag is provided with a vent opening and the filter construction is positioned in such a way that the gas outlet of the filter construction communicates with the vent opening of the bag.
[00100] In a modality of the fourth and fifth aspects above, the ostomy discharge is collected during the night.
[00101] An ostomy method and accessory as described in the fourth and fifth aspects allows a user to sleep almost all night, due to the fact that he is not bothered by the distension of his ostomy bag.
[00102] In a sixth aspect of the invention, the invention relates to a method of reducing the number of distension (s) that occurs in an ostomy accessory comprising a pouch and a filter construction comprising a first layer of metallized foil and a second layer of foil that defines a wrap, the wrap including a pre-filter element, where multiple gas inlets are provided in at least one of the layers of foil, a gas outlet is provided in the second layer of metallized leaf, the filter construction is fixed inside the bag, in such a way that a main part of the filter construction is left suspended in the bag, the method comprising placing the ostomy accessory around a stoma.
[00103] In a seventh aspect of the invention, the invention relates to an ostomy accessory comprising a pouch and a filter construction comprising a first layer of metallized foil and a second layer of metallized foil that define a wrap, the wrap includes a pre-filter element, where multiple gas inlets are provided in at least one of the layers of metallized foil, a gas outlet is provided in the second layer of metallized foil, the filter construction is fixed inside the bag , in such a way that a main part of the filter construction is left suspended in the bag, for use in a method of reducing the number of distension (s) that occur in an ostomy accessory, the method comprising placing the ostomy accessory around a stoma.
[00104] Clinical tests show that ostomy accessories according to this invention have the ability to reduce the number of strains that occur by more than 50% - see paragraph below. This means that a user will be less bothered by strains when using an ostomy accessory according to this invention, thus leading to fewer occurrences of embarrassing situations and less separations of the bag from the accessory waferou from the user's skin.
[00105] In an eighth aspect of the invention, the invention relates to a method of increasing the time before the strain occurs in an ostomy accessory comprising a pouch and a filter construction comprising the first layer of metallized sheet and a second layer of metallized foil that define a wrap, the wrap including a pre-filter element, in which multiple gas inlets are provided in at least one of the layers of metallized foil, a gas outlet is provided in the second layer of metallized sheet, the filter construction is fixed inside the bag, in such a way that a main part of the filter construction is left suspended in the bag, the method comprising placing the ostomy accessory around a stoma.
[00106] In a ninth aspect of the invention, the invention relates to an ostomy accessory comprising a pouch and a filter construction comprising the first layer of metallized foil and a second layer of metallized foil that define a wrap, the wrap includes a pre-filter element, where multiple gas inlets are provided in at least one of the layers of metallized foil, a gas outlet is provided in the second layer of metallized foil, the filter construction is fixed inside the bag , in such a way that a main part of the filter construction is left suspended in the bag, for use in a method of increasing the time before the strain occurs in an ostomy accessory, the method comprising placing the ostomy accessory around of a stoma.
[00107] Clinical tests show that ostomy accessories according to this invention have the ability to increase the time before a strain occurs by more than 70% - see the paragraph below. This means that a user will be able to use an ostomy accessory according to the invention for a longer time before having problems with distension. This can lead to better and more uninterrupted sleep at night, due to the fact that the user does not have to get up to allow air to escape from the ostomy accessory.
[00108] In a sixth, seventh, eighth or ninth aspect of the invention, the ostomy accessory is placed around a colostomy and the first and second layers of metallized foil are provided with gas intakes in a number that exceeds 50 The number of gas inlets for use with a colostomy can also be greater than 75, such as more than 100 and even more than 150 orifices.
[00109] In another embodiment of the sixth, seventh, eighth or ninth aspect of the invention, the ostomy accessory is placed around an ileostomy and at least one of the layers of metallized foil is provided with at least one gas inlet of a diameter of at least 1 mm and the prefilter element has a volume sufficient to handle the liquid exit that enters the prefilter element during the normal wear time. The number of gas inlets can, in this modality, be 2 holes.
[00110] A volume large enough to handle the liquid outlet means that the thickness of the pre-filter (in the axial direction of the stoma) is at least 5 mm and the area of the pre-filter in the plane of the filter construction is at least 40% of the rear wall area.
[00111] Other aspects of the ostomy accessory as described above can also be combined with the fourth to ninth aspects of the invention. Clinical Tests
[00112] The ostomy accessories as described above were tested by users who have a colostomy (20 users) and users who either have an ileostomy (20 users). The tests were purchased with reference to ostomy accessories that comprise two filter constructions, each with a 50 mm x 10 mm x 3 mm porous material pre-filter and a 30 mm x 7 mm x carbonized foam deodorizing filter. 3 mm. The study was designed as an open, randomized, crossover study. All users used one-piece ostomy accessories and often had to experience strain problems at least once a week. Users were instructed to change the ostomy accessory when they were distended and, otherwise, should follow the normal exchange pattern.
[00113] Both types of users experienced an increase in the time before the strain occurred and a reduction in the number of occurrences of strain.
[00114] For colostomy users, the number of reference ostomy accessories tested was 567 accessories and the number of ostomy accessories according to this invention was 526 accessories. The number of strains in the reference accessories was 129 and the number of strains in the accessories according to this invention was 59. Thus, the number of strains experienced by the accessories of that invention was reduced by 52%.
[00115] For ileostomy users, the number of ostomy reference accessories tested was 294 accessories and the number of ostomy accessories according to this invention was 283 accessories. The number of strains in the reference accessories was 161 and the number of strains in the accessories according to this invention was 74. Thus, the number of strains experienced by the accessories of this invention was reduced by 62%.
[00116] Colostomy users who tested the reference accessories experienced, on average, a strain of approximately every 1.5 days (0.72 strains / per user / per day). When the same users tested ostomy accessories according to this invention, they experienced, on average, a strain of approximately every 4th day (0.26 strains / per user / per day). Thus, the time before the strain occurred increased by 74%.
[00117] Ileostomy users who tried the reference accessories experienced, on average, a strain almost daily (0.90 strains / per user / per day). When the same users tested ostomy accessories according to this invention, they experienced, on average, a stretching of approximately every 3rd day (0.34 strains / per user / per day). Thus, the time before the strain occurred increased by 82%. Example - conducting filter construction tests
[00118] The tests were performed with the use of a filter tester that can hold an ostomy bag (= ostomy accessory) while the pressure and air flow are monitored. The device includes a different pressure gauge to monitor the pressure and a flow controller to monitor the air flow. In addition, the device can apply a controlled simulation of a contamination event with an ostomy bag filter. The filter tester applies a controlled massage and shaking an ostomy bag containing a simulated neck or ileum outlet. The simulated neck outlet has a porridge-like consistency and the ileum outlet has a syrup-like consistency.
[00119] The tests were carried out by assembling an ostomy bag containing a simulated neck outlet in the filter test apparatus. After that, the ostomy bag was inflated to 1 kPa (10 mbar). When the pressure was stable at 1 kPa (10 mbar), the flow through the uncontaminated filter construction was determined by reading the value on the flow controller.
[00120] When the uncontaminated flow was observed, the ostomy bag was emptied and the first contamination cycle was carried out allowing the massage plate to advance to the ostomy bag and massage the outlet containing the ostomy bag, resulting in contamination controlled surfaces within the ostomy bag, including filter construction.
[00121] When the cycle was completed, the ostomy bag was again inflated to 1 kPa (10 mbar) and the flow through the filter construction was determined as described above.
[00122] This contamination step was repeated until the filter construction was obstructed. The flow through the filter construction was determined at 1 kPa (10 mbar) for each contamination cycle.
[00123] Different test series were performed.
[00124] 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 prefilter element that has a generally circular periphery of about 110 mm and that has an inspection hole of about 60 mm cut off the center. The filter construction is additionally provided with an orifice for a deodorizing element of approximately 30 mm positioned at the bottom of the pre-filter element. The reference filter construction comprises a 50 mm x 10 mm x 3 mm porous material pre-filter and a 30 mm x 7 mm x 3 mm carbonized foam deodorant filter.
[00125] The ostomy bags according to this invention were of two different types. In the 1.1 series, ostomy bags were bags adapted for use with a colostomy and were then equipped with 96 holes that function as gas inlets. The holes were drilled with a needle with a diameter below 1 mm; approximately 0.5 mm. Six (6) holes approximately 1 mm in diameter were included. In the series, four ostomy bags according to this invention and five reference bags were tested. All bags (sample bags and reference bags) were loaded with a test medium that is comparable to porridge like the aforementioned outlet. The table below shows how many contamination cycles each bag has undergone before it does not flow through the bag.
Table 1
[00126] From Table Table 1 above, it is observed that the ostomy bags according to this invention (sample 1 to sample 4) and loaded with neck-type outlet to a great extent have a better performance than the reference bags (ref. 1 to ref. 5). On average, the ostomy bags according to this invention lasted 13 cycles of contamination compared to only 1 to 2 cycles for the reference bags.
[00127] The 1.2 series comprises ostomy bags according to the invention and adapted for use with an ileostomy. These bags were then provided with 2 holes of approximately 1 mm in diameter that act as gas inlets. In this series, four ostomy bags according to this invention and five reference bags were tested. All bags (sample bags and reference bags) were loaded with a test medium that is comparable to the syrupy outlet mentioned earlier. The table below shows how many contamination cycles each bag was subjected to before it did not exist through the bag.
Table 2
[00128] From Table 2 above, it is observed that the ostomy bags according to this invention (sample 1 to sample 4) and loaded with ileo outlet to a great extent have a better performance than the reference bags (ref 1 to ref 5). On average, the ostomy bags according to this invention lasted 12 cycles of contamination compared to just 1 cycle for the reference bag.
[00129] The 2nd series of tests refers to the influence of the size of the holes. Only ileostomy bags were tested in the series, due to the fact that the outlet of a colostomy can include both a thicker and a thin outlet. Therefore, the size influence of the holes is more important for testing bags that include only the fine outlet. In the 2.1 series, ileostomy bags with 2 mm holes were tested. These results are compared to the 2.2 series, which includes ileostomy bags with 1 mm holes. The Table below shows the results of these two test series.
Table 3
[00130] The results in the table above show that 1 mm holes are less preferred than 2 mm holes. This is due to the fact that the thin outlet is able to block the smaller holes (1 mm) and due to the fact that the filter construction comprises only 2 gas inlets, it is very important that both are kept open. The 2 mm holes will not be blocked by the fine outlet. In addition, the large pre-filter element is capable of handling (to contain) the outlet that enters the pre-filter element - at least for approximately 9 cycles (series 2.1). Detailed Description of Drawings
[00131] Figure 1 illustrates an ostomy accessory 1 according to an embodiment of the invention. The ostomy accessory comprises a pouch that has a rear wall 2 and a front wall 3, which are welded together along its rim (not shown). The rear wall 2 has a refuse inlet opening 4, which in this mode is surrounded by a skin-friendly adhesive 5, so this is called the one-piece accessory. Stool 6 is also shown. The filter construction 10 in the ostomy accessory comprises a first layer of metallized sheet 11, and a second layer of metallized sheet 12, welded together along its outer contour 13. The layers of metallized sheet 11, 12 are provided with numerous holes 14 that act as gas inlets for the construction of filter 10. The pre-filter element 15 is, in this embodiment, a generally annular element with a cutout 16 for the deodorizing filter 17. The deodorizing filter 17 is, in this embodiment , a disk-shaped element. The deodorizing filter 17 is confined to metallized sheets impermeable to gas and liquid 18, 19. These metallized sheets 18, 19 are welded or glued to the layers of metallized sheet 11, 12 that confine the entire filter construction 10 and, additionally, welded or glued to the surfaces of the deodorizing filter 17. Thus, the gas flowing in the filter construction is confined to flow through the deodorizing filter from the periphery towards the center. The filter construction 10 also includes a membrane 20 placed in the central part of the deodorizing filter 17, in order 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 ostomy accessory 1. In this way, the filter construction 10 is attached to the ostomy accessory 1. The gas outlet 22 takes the deodorized gas to the external environment through the vent 23 in the front wall 3 of the bag. The drawing is not to scale.
[00132] Figures 2 and 3 illustrate another embodiment of an ostomy accessory 101 according to the invention. Figure 2 shows a view of the ostomy accessory 101 seen from the rear side and Figure 3 shows a view seen in cross section. The ostomy accessory 101 can be supplied in at least three sizes, MINI, MIDI and MAXI (as shown in Figure 2). The three sizes are shown to illustrate the relative size relationship between filter construction 110 and ostomy accessory 101 for these three sizes. This modality differs from the modality in Figure 1 in that the pre-filter element 115 includes an inspection window 125 large enough to view stoma 6 and the area immediately around stoma 6. Inspection window 125 is made of the same metallized sheets 111, 112 that are used to confine the filter construction 110, which is possible due to the fact that metallized sheets 111, 112 in this embodiment are transparent. Thus, the inspection window 125 is made by welding the metallized sheets in a circle 126, in order to prevent any matter in the filter construction from entering and obstructing the view through the inspection window 125. It is understood that the filter construction of the The present invention can also be incorporated into other sizes, types and formats of body waste collection bags.
[00133] The gas intakes 114 for the filter construction are numerous and, in general, placed around the inspection window 125. The bottom of the pre-filter element 115 includes a cutout 116 for the deodorizing filter 117. The deodorizing filter 117 is confined to metallized sheets 118, 119, in order to ensure that the gas is confined to traverse the deodorizing filter across the periphery towards the center, just like the modality in Figure 1. As with 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 in Figure 1.
[00134] The filter construction 110 is provided with transport means 130, 131 of metallized sheet. These means of transport 130, 131 can be welded to the rim of the bag and aid in transport and control of the position of the filter construction 110.
[00135] Figure 4 illustrates an exploded view of the filter construction 110 of Figures 2 and 3 - however, the means of transport for controlling the filter construction are not shown. The filter construction 110 includes a filter flange 121, a membrane 120, a second layer of foil 112 with the numerous holes providing gas intakes 114, a foam pre-filter element 115 with a cutout 116 for the filter deodorant, a deodorant filter 117 with a foil 118 on top, a second foil 119, so that foil 118, 119 adjoin the deodorant filter and, finally, the first foil layer 111 is also provided with numerous holes as gas inlets 114. The positioning of the orifices meets the requirements mentioned above for the distance between orifices.
[00136] Figure 5 illustrates an ostomy accessory 201 according to the invention, in which the pre-filter element 215 in filter construction 210 is, in general, shaped in banana and placed above the refuse opening 204 The pre-filter element comprises a first 211 and a second 212 layers of metallized foil, which during manufacture form part of greater metallized sheet lengths 241, 242. The two greater lengths of metallized sheets 241, 242 extend from one edge top edge 243 towards a bottom edge 244. Top edge 243 is placed above the top rim of the ostomy bag 201 and extends below the bottom edge of filter construction 210. Likewise, the larger metallized sheets 241, 242 extend beyond the sides of the bag. In these larger metallized sheets 241, 242, the filter construction 210 that includes the inspection window 225 is provided by welding the metallized sheets on the inner periphery 226 of the pre-filter element (the inner curved side of the banana shape), along from the lower edges 227, 228 of the prefilter element and on the outer periphery 229 of the prefilter element (the outer curved side of the banana shape). Holes 245 are used to control the construction of the filter during manufacture. When accessory 201 is manufactured, this finished filter construction is attached to either one of the front or rear wall during a separate welding process or to the front and rear wall during welding of the bag rim.
[00137] The lengths of metallized sheet such as those shown in Figure 5 can also be used to manufacture the modalities of Figures 1 to 4.
[00138] Figure 6 illustrates a filter construction 310, which is provided with a drain opening 350. The drain opening 350 comprises a one-way valve 351 with two foil flaps 352, 353 that provides a single route outside the building filter 310. During normal use, when the filter construction is positioned with the drain opening 350 facing downwards, the liquid outlet in the filter construction 310 will travel towards the drain opening 350 and will exit through the unidirectional valve 351 and for the bag. Due to the one-way function of valve 350, it will prevent liquid from escaping into the bag from entering valve 350 and filter construction 310.
[00139] Figure 7 illustrates part of a filter construction 410, in which deodorizing filter 417 is confined in a three-layer structure of metallized sheet 418, 410. Figure 7A illustrates part of the filter construction and Figure 7B illustrates the three layers that constitute the metallized sheets 418 and 419. The three-layer structure of the metallized sheet comprises an 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 inward 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 previously mentioned, the structure of the metallized sheet 419 facing towards the gas outlet must be impermeable to gas and liquid, while the structure of the metallized sheet 418 does not need to be impermeable to gas, due to the fact that it faces inwards in the bag in use. Figure 7A illustrates part of the filter construction 410 which includes the pre-filter element 415 and the metallized sheets 411, 412 that confine the filter construction. The gas outlet 422 of the deodorizing filter can be covered with a membrane 420 as shown in the figure. The metallized sheet structure 419 can be welded to the front wall 403 of the bag.
[00140] Figure 8 illustrates an ostomy accessory 501 according to the invention. The ostomy accessory 501 is shown in Figure 8 in the first configuration when the bag is neither inflated nor inflated. The ostomy accessory 501 includes a filter construction 510 according to the invention. The filter construction has a width b that is at least 60% (preferably at least 80%) of the bag width B in the first configuration of the bag. In this connection, the 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 across the bag (or filter construction).
[00141] Figure 9 illustrates an ostomy accessory 501 according to the invention shown in the second configuration, when the bag is stretched or inflated. As can be seen from the figure, the bag width B 'in this configuration is reduced, so that it is not less than the width b of the filter construction.
[00142] Figure 10 illustrates another construction of filter 610 according to the invention. The filter construction comprises a first layer of foil 611 and a second layer of foil 612. A foam pre-filter 615 is confined to the layers of foil. The two layers of metallized foil 611, 612 are provided with gas inlets 614 in the form of holes. The construction of filter 610 also includes a deodorizing filter 617. From the figure, it is noted that the outlet 640 that entered the pre-filter 615 travels only a certain distance in the pre-filter. Therefore, if the gas inlets 614 are positioned with a greater distance from each other than the maximum penetration length of the outlet, then the outlet will not be able to travel from a gas inlet to a neighboring gas inlet.
[00143] Figure 11 illustrates a schematic drawing of the filter test apparatus 1000 used in the Example mentioned above. The filter testing apparatus 1000 comprises a flow controller 1001 for measuring flow through the filter construction and a different pressure gauge 1002 for measuring pressure in the ostomy bag. This flow controller and pressure gauge are well known in the art. The filter testing unit 1003 is a control unit capable of delivering a controlled massage and shaking an ostomy bag. The ostomy bag (not shown), during testing, is held in the ostomy bag retainer 1004 which comprises a retaining plate, 1005, 1006 on each side of the bag. The filter testing unit 1003 controls a massage plate 1007 to apply the controlled massage of the bag.
[00144] Figures 12 and 13 illustrate the results of test series 1. Figure 12 illustrates results of tests performed on colostomy bags - which correspond to test series 1.1 described above - and Figure 13 illustrates results of tests performed on colostomy bags. tests on ileostomy bags - which correspond to the series of tests 1.2 described above. The difference between ostomy bags according to the invention and ostomy bags with standard filters (described above) is evident. In both figures, the dotted lines show results of performing ostomy bag tests according to the invention and the dashed lines (left in the figures) show results of performing ostomy bag tests with standard filters. The solid lines between the dotted and dashed lines illustrate the average values. In Figure 13, only the middle line for the standard filter is visible, due to the fact that all filters lasted only 1 cycle. Thus, for colostomy bags, in Figure 12, it is illustrated that an ostomy bag according to the invention - on average, lasts 13 cycles of contamination before the flow through the bag is below an acceptable level. This should be compared to an average value for an ostomy bag with a standard filter that only lasts 1 to 2 cycles. For ileostomy bags, Figure 13 shows that an average ostomy bag according to the invention lasts 12 cycles. A medium ostomy bag with a standard filter lasts only 1 cycle.
[00145] Figure 14 illustrates test results that correspond to test series 2 above. Figure 14 reveals that the use of holes only 1 mm 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 2 mm holes (the full line).

权利要求:
Claims (20)
[0001]
1. Ostomy accessory (1,101, 201, 510), comprising a pouch that includes a front wall (3, 403) and a rear wall (2), a refuse opening in the rear wall (2) to let the exit of the stoma into the bag, at least one vent opening to let the gas escape the bag, a filter construction (10, 110, 210, 310, 410, 510, 610) comprising a first (11, 111, 211, 411, 611) and second (12, 112, 212, 412, 612) metallized foil layers that define a wrap, the wrap including a pre-filter element (15, 115, 215, 415, 615) , a filter construction (10, 110, 210, 310, 410, 510, 610) is fixed inside the bag so that each of the layers of metallized sheet is substantially parallel to the front wall (3, 403) and rear (2) of the bag, the first layer of metallized foil (11, 111, 211, 411, 611) facing the rear wall (2) and the second layer of metallized foil (12, 112, 212, 41 2, 612) faces the front wall (3, 403) of the bag, the filter construction (10, 110, 210, 310, 410, 510, 610) is provided with a gas outlet (22, 422) at the second metallized sheet placed in alignment with the vent opening, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) is equipped with gas inlets (14, 114, 614) by less in the second layer of metallized foil (12,112, 212, 412, 612), and where the attachment is such that a large part of the filter construction (10, 110, 210, 310, 410, 510, 610) is left suspended In the purse.
[0002]
2. Ostomy accessory (1, 101, 201, 501) according to claim 1, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) includes a deodorizing filter (17, 117, 417, 617) inside the wrap.
[0003]
3. Ostomy accessory (1, 101, 201, 501) according to either of claims 1 or 2, characterized by the fact that the holes that function as gas inlets (14, 114, 614) are provided both at first layer of metallized sheet (11, 111,211,411,611) as in the second layer of metallized sheet (12, 112, 212, 412, 612).
[0004]
4. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that the number of gas inlets (14, 114, 614) is greater than 50, as greater than 75, as greater than 100, as greater than 150.
[0005]
5. Ostomy accessory (1, 101, 201, 501), according to claim 1, characterized by the fact that the number of gas inlets (14, 114, 614) is greater than 50 and provided both in the first ( 11, 111, 211, 411, 611) as in the second metallized sheet (12, 112, 212, 412, 612), where the gas inlets (14, 114, 614) comprise holes that have a diameter below 1 mm , such as approximately 0.5 mm, as well as holes that have a diameter of approximately 1 mm or more, such as approximately 2 mm.
[0006]
6. Ostomy accessory (1, 101, 201, 501) according to any one of claims 1 to 3, characterized by the fact that the number of gas inlets (14, 114, 614) is 2.
[0007]
7. Ostomy accessory (1, 101, 201, 501), according to claim 1, characterized by the fact that the gas inlets (14, 114, 614) have a diameter of at least 1 mm as approximately 2 mm and where the area of the pre-filter element (15, 115, 215, 415, 615) is greater than 40% of the area of the rear wall (2).
[0008]
8. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that the pre-filter area (15, 115, 215, 415, 615) is at least 20% of the bag area when taken on the bag plane.
[0009]
9. Ostomy accessory (1, 101, 201, 501), according to claim 3, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) gets disintegrated when the bag is loaded as a result of the relationship between the width of the filter construction (10, 110, 210, 310, 410, 510, 610) and the width of the ostomy accessory (1, 101, 201, 501) in the transverse direction.
[0010]
10. Ostomy accessory (1, 101, 201, 501), according to claim 4, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) has a width in transverse direction that is at least 100% or at least 80% or at least 60% of the bag width in the transverse direction.
[0011]
11. Ostomy accessory (1, 101, 201, 501) according to claim 1, characterized by the fact that the gas inlets (14, 114, 614) have a diameter of at least 1 mm, and, wherein the area of the pre-filter element (15, 115, 215, 415, 615) is greater than 40% of the area of the rear wall.
[0012]
12. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that a first distance between two neighboring orifices is such that the liquid cannot travel from one orifice to the orifice neighbor within normal use time, where the first distance is greater than 10 mm.
[0013]
13. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that a second distance from the deodorizing element to the nearest gas inlet is such that the liquid cannot travel from the nearest gas inlet to the deodorizing element within the time of normal use, where the second distance is greater than 15 mm.
[0014]
14. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that a third distance between the gas inlets (14, 114, 614) and the rim of the construction of filter can be larger than 5 mm.
[0015]
15. Ostomy accessory (1, 101, 201, 501) according to any of the preceding claims, characterized in that the filter construction casing comprises a drain opening (350) facing downwards in the ostomy accessory .
[0016]
16. Ostomy accessory (1, 101, 201, 501) according to any of the preceding claims, characterized by the fact that the pre-filter (15, 115, 215, 415, 615) comprises a cutout (116) for the deodorizing filter.
[0017]
17. Ostomy accessory (1, 101, 201, 501), according to any of the preceding claims, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) incorporates a inspection window (125, 225) that allows the user to visually access the stoma and the peristomal area.
[0018]
18. Ostomy accessory (1, 101, 201, 501) according to any one of the preceding claims, characterized by the fact that the filter construction (10, 110, 210, 310, 410, 510, 610) comprises a or more means of transport (130, 131) attached to the front and / or rear wall at the time of the contour welding process step.
[0019]
19. Method of reducing the number of distension (s) that occurs (m) in an ostomy accessory (1, 101, 201, 501) as defined in claim 1 comprising a bag and a filter construction (10, 110, 210 , 310, 410, 510, 610) comprising a gas outlet (22, 422) provided in the second layer of metallized foil (12, 112, 212, 412, 612) and a first layer of metallized foil (11, 111, 211, 411, 611) and a second layer of metallized foil (12, 112, 212, 412, 612) that define a wrap, the wrap including a pre-filter element (15, 115, 215, 415, 615 ), characterized by the fact that the ostomy accessory (1, 101, 201, 510) comprises multiple gas inlets (14, 114, 614) supplied in at least one of the foil layers and the filter construction (10, 110, 210, 310, 410, 510, 610) is fixed inside the bag so that a main part of the filter construction (10, 110, 210, 310, 410, 510, 610) is left suspended in the bag, where the comp method recommends placing the ostomy accessory (1, 101, 201, 501) around a stoma.
[0020]
20. Method of increasing the time before the distention occurs in an ostomy accessory (1, 101, 201, 501) as defined in claim 1, comprising a bag and a filter construction (10, 110, 210, 310, 410 , 510, 610) comprising a gas outlet (22, 422) provided in the second layer of metallized sheet, and a first layer of metallized sheet (11, 111, 211, 411, 611) and a second layer of metallized sheet ( 12, 112, 212, 412, 612) that define a wrap, the wrap including a pre-filter element (15, 115, 215, 415, 615), characterized by the fact that multiple gas inlets (14, 114, 614) are provided in at least one of the layers of metallized sheet, the filter construction (10, 110, 210, 310, 410, 510, 610) is fixed inside the bag so that a main part of the filter construction (10, 110, 210, 310, 410, 510, 610) is left suspended in the bag, and the method involves placing the ostomy accessory (1, 101, 201, 501) around an es become

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法律状态:
2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-03-03| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2020-06-30| B09A| Decision: intention to grant|

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2020-07-28| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 01/06/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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DKPA201070245|2010-06-04|

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DK201070245|2010-06-04|

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DKPA201070246|2010-06-04|

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DK201070246|2010-06-04|

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DK201070473|2010-11-08|

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DK201070476|2010-11-08|

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DK201070475|2010-11-08|

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DKPA201070475|2010-11-08|

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DKPA201070473|2010-11-08|

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DKPA201070476|2010-11-08|

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DKPA201070498|2010-11-19|

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PCT/DK2011/050189|WO2011150936A1|2010-06-04|2011-06-01|An ostomy bag with a filter construction|

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