RU2575548C2 - Device for stomal application with filtering construction - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device for stomal application contains bag, containing front wall and back wall, inlet hole for excretions, located in back wall to make it possible for excretions from stoma to get into bag, ventilation hole for release of gas from bag, and filtering construction, which contains first and second foil layers, restricting closed area. Filtering construction is fixed inside bag in such a way that each foil layer is in fact parallel to front and back bag wall. First foil layer faces back wall and second foil layer faces front bag wall. Filtering construction is provided with holes for input of gas, located in foil layer, and hole for output of gas in second foil layer, located on one line with ventilation hole. Closed area contains pre-filter. Quantity of holes for gas input is higher than 50, with said holes being provided both in first and in second foil layer. Method for reducing quantity of inflations, taking place in device for stomal application, which contains bag and filtering construction, containing first foil layer and second foil layer, restricting closed area. Closed area includes pre-filter, where multitude of holes for gas input are provided in foil layer, and hole for gas output is provided in second foil layer. Filtering construction is fixed inside bag in such a way that main part of filtering construction is loosely hung in bag. Method contains placement of device for stomal application around stoma. Method for increasing tine before development of inflation in device for stomal application, which contains bag and filtering construction, containing first foil layer and second foil layer, restricting closed area. Closed area includes pre-filter, where multitude of holes for gas input are provided in foil layer, and hole for gas output is provided in second foil layer. Filtering construction is fixed inside bag in such a way that main part of filtering construction is loosely hung in bag. Method contains placement of device for stomal application around stoma.

EFFECT: inventions make it possible to prevent or reduce bag inflation.

23 cl, 14 dwg, 3 tbl

Description

The invention relates to a device for ostomy use, which comprises a filter structure enclosed in two layers of foil: a first layer of foil and a second layer of foil. The filter structure comprises openings in at least one of the foil layers, and the openings function as gas inlets. The invention also relates to a method for collecting discharge from an ostomy, a method for reducing the number of blisters, and a method for increasing the time before the occurrence of blistering. Finally, the invention relates to an ostomy device for use in a secretion collection method, an ostomy device for reducing the number of blisters, and an ostomy device for increasing the time before the blister occurs.

BACKGROUND OF THE INVENTION

In surgery for the treatment of diseases of the gastrointestinal tract, in many cases the result of such an intervention is an abdominal stoma in the patient’s abdominal wall, such as a colostomy or ileostomy, to excrete internal secretions. The excretion of internal secretions, including intestinal gases, cannot be regulated as desired. To this end, the user has to rely on a device to collect the substance exiting from such an opening into a bag, which is then emptied and / or thrown away at a suitable time.

The volume of excreted intestinal gases may exceed the volume of excreted solid and liquid fecal matter by several hundred percent, and, therefore, there is a constant need for continuous or frequent ventilation of the intestine or bag. Typically, outgoing intestinal gases are absorbed by a suitable filter. As a rule, an active filter is activated carbon, which absorbs H ₂ S, which is the main component of the smell of intestinal gases.

During use of the collection bag, discharge from the colostomy or ileostomy can adhere to the surface of the filter facing the inside of the collection bag. Over time, this leads to a clogged filter, which reduces the filter capacity. When the filter is completely clogged, it will cease to fulfill its functions and the bag will be filled with gases and expand, this effect is also called bloating. This can put the user in an awkward situation, as the bag will be visible through the clothes. It can also cause the device to separate from the user's skin or the bag to separate from the plate.

Summary of the invention

The invention relates to a device for ostomy use with a filter design. The device bag for ostomy use includes a front wall and a rear wall. The filter structure contains a first and second layer of foil, providing a closed area for placing elements in the filter structure. The filter structure can be attached inside the bag, so that in use the filter structure is essentially freely suspended in the bag, which means that the filter structure can follow the movements of the bag and can also wrinkle and bend when used. The holes are located in at least one of the first or second layer of the foil in order to create openings for the inlet of gas into the filter structure. Such a device for ostomy use during use will be able to remove excess gas through the filter at any time, since the presence of a freely suspended filter structure ensures that at least one inlet is always open.

A brief description of the graphic material

Figure 1 shows an embodiment of a device for ostomy use according to the invention.

Figures 2 and 3 show another embodiment of a device for ostomy use according to the invention.

Figure 4 shows an exploded view of the filter structure according to the embodiment of figures 2 and 3.

Figure 5 shows another embodiment of the device for ostomy use according to the invention.

Figure 6 shows an embodiment of a filtering structure equipped with a drainage hole.

Figure 7 shows an embodiment of a deodorizing filter enclosed in a three-layer foil structure.

On Fig depicts an embodiment of the device for ostomy use according to the invention. Figure 1 shows the first configuration of the bag.

Figure 9 shows the same embodiment of a device for ostomy use according to the invention; however, FIG. 9 shows a second configuration of the device.

10 shows a filtering structure for use in an ostomy device according to the invention.

Figure 11 shows the test setup that was used to test bags of devices for ostomy use according to the invention.

12-14 show the test results of devices for ostomy use according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

In a first aspect, the invention relates to a device for ostomy use, which comprises

bag containing

at least one vent for venting gas from the bag

a filter structure comprising a first foil layer and a second foil layer defining a closed region, wherein the closed region includes a pre-filter

at least one gas inlet opening located in at least one of the foil layers: the first and / or second

at least one gas outlet located in the second foil layer,

where the second layer of foil of the filter structure is attached either to the front wall or to the rear wall of the bag, so that the gas outlet for the filter structure is connected to the ventilation hole of the bag and,

where the connection is made in such a way that the main part of the filter structure is freely suspended in the bag.

A device for ostomy use with a filter structure, as described above, will have excellent properties to prevent or at least reduce bloating, since the filter structure is freely suspended in the bag.

The term "freely suspended" means that the filter structure is able to essentially seamlessly follow the movements of the bag. The filter structure can only be attached in the area that directly surrounds the ventilation opening, leaving most of the circuit (or the entire circuit) of the closed area not attached to the device for ostomy use. As an alternative or addition, the filter structure is attached at individual points on the surface of the second foil layer. This means that in one embodiment, the main part of the filter structure can be wrinkled and bent during use, so that the filter structure does not adhere to the walls of the bag, and due to which at least the gas inlet opening (some of the openings) is constantly open. By the phrase “crumple and bend” is meant that the filter structure takes on a wavy shape in the plane of the bag.

In another embodiment, the freely suspended state of the filter is such that the filter structure is cantilevered attached inside the bag.

By the main part of the filter structure is meant that the surface area of the attached part of the filter structure is significantly less than the surface area of the rest of the filter structure. For example, the attached area may be less than 20% of the surface area of the filter structure, for example 10% or 5%, or even not more than 1%.

A device for ostomy use is well known in the art. Typically, it comprises a bag containing a front wall and a back wall of a foil material impervious to gas and liquid (e.g., polyethylene (PE), polyvinyl chloride (PVC) or ethylene vinyl acetate (EVA)), which is welded or glued along the edges or edges so as to form a bag bounding the secretion collection chamber. The bag can only be welded or glued along the edge so that a hole is formed in the bottom of the bag to empty the bag. In this case, the bag may be equipped with means for closing this hole. The bag usually contains an inlet for discharge, the outer side of which is equipped with a means of mechanical or adhesive bonding to attach to the underbody plate or is equipped with a non-irritating skin adhesive adapted to directly adhere to the wearer's stomach.

Typically, the discharge inlet is located at the top of the ostomy bag so that when the user stands up, the discharge inlet will be above the midline of the ostomy bag. Due to this, a larger collection volume remains under the discharge inlet. Thus, the upper part of the ostomy device and the bag are the part closest to the discharge inlet, and the lower part is the opposite part. The longitudinal direction of the device for ostomy use and the bag is the direction from the top to the bottom. The transverse direction of the device for ostomy use, the bag and the filter structure located in the bag is the direction in the plane of the bag, perpendicular to the longitudinal direction. The axial direction is the direction of the stoma.

The filter structure comprises first and second foil layers defining a closed area for the filter structure. The first and second layers of the foil can be laminated to the surface of the elements (for example, to a pre-filter) in the filter structure. By lamination, it is meant that the foil layers are attached to the entire surface so that there is no space between the elements and the foil layers. Foil layers can be bonded by bonding or heat welding. When the first and second foil layers are laminated to the surface of the elements, the foil layers do not necessarily also join together along their contour. If the foil layers are not connected along their contour or at least partially not connected along their contour, the unconnected parts also limit the gas inlet openings leading to the filter structure.

Alternatively, the first and second layers of the foil can be connected to each other along the entire contour so as to limit the closed region. In this case, the pre-filter during production may be slightly compressed in the cross-sectional direction of the filter structure. Compression of the pre-filter ensures that there is no gap between the foil layers and the pre-filter, thereby reducing the risk of liquid or semi-solid parts of the discharge passing the pre-filter. Thus, it is ensured that liquid material entering the filter structure will flow through the pre-filter.

Foil layers can be joined to each other by welding, which is a fast process used in production. Thus, the foil layer can be weldable. The foil layers can also be bonded to each other by gluing, for example, using acrylate and / or hot melt adhesive. In addition, the foil may be impervious to gas and liquid. A material such as PE foil may be suitable for use. Alternatively, the foil may have a non-woven or fabric base. However, it is necessary to ensure that liquid or semi-solid parts of the precipitates pass at least some distance through the pre-filter before they reach the deodorizing element. Consequently, the foil layers immediately surrounding the deodorizing element must be impervious to gas and liquid. In one embodiment, gas and liquid impervious foil layers may be provided at least 3 cm from the deodorizing element. In another embodiment, gas and liquid impervious foil layers may be provided at a distance of only 15 mm from the deodorizing element. It depends on the type of discharge in the bag, as described below.

In one embodiment, the filter structure includes a deodorizing filter located within a closed area. Alternatively, the deodorizing filter may be located on the outer surface of the bag so as to communicate with the ventilation hole in the bag. The deodorizing filter can also be located inside the bag and communicate with the ventilation hole, but outside the enclosed area and communicate with the gas outlet.

A deodorizing filter can be provided in the form of filter blocks, which are usually used in bags for ostomy use. Typically, a deodorizing filter comprises a foil layer laminated to the surfaces of the deodorizing filter, which is parallel to the direction of gas flow. This ensures gas is supplied in the intended flow direction in the deodorizing filter. Thus, sufficient deodorization is achieved. The filter structure may contain more than one deodorizing filter, for example two or three. The number of ventilation holes in the bag should correspond to the number of deodorizing filters in the filter structure. For example, a filter unit having a shape and a filtration method can be used, as in the Filoprodor® filter of Coloplast A / C. This filter unit contains a disc-shaped porous element, where the porous material is saturated with carbon. The porous element is coated with a gas-tight foil on both sides of the disk, with the exception of the hole made in the center of one of the layers of the foil. This hole performs the function of a hole for discharging gas into the deodorizing filter, and the periphery of the element functions as a gas inlet. The gas flow through the deodorizing filter can also be directed in the opposite direction, so that the gas enters the deodorizing filter in the center and leaves it at the periphery. When the gas travels a distance from the periphery of the disk to its center (or vice versa), it is sufficiently deodorized. The diameter of such an element may be from about 20 to 25 mm, but may be more or less depending on the deodorizing ability.

The deodorizing filter can also be elongated with an inlet located at one end and an outlet located at the other end. Such a deodorizing filter may be the filter of the same type as described in European patent No. EP0235928B1.

The deodorizing filter may be a carbon-saturated porous material such as foam, felt, non-woven material and the like, or activated carbon may be contained in a carbonized material such as, for example, carbonated viscose and the like. Coal may be unactivated or activated by the use of catalytic compounds, such as copper oxide, chromium oxide, potassium permanganate or other catalytic compounds.

In a preferred embodiment, at least one of the first and / or second foil layer is provided with openings whose diameter is approximately 0.1-2.0 mm. Both foil layers can also be provided with holes. These openings function as gas inlets in order to allow gas to enter the filter structure. The small size of the holes helps to prevent the entry of semi-solid and, to some extent, liquid material into the filter structure, but allows gas to penetrate inside it.

The openings in both layers of the foil minimize the risk of all inlets overlapping with stoma discharge - even if the discharge is located near the filter structure in the bag. The location of the selection depends on the user's movements (for example, the user is lying down or standing up) and on the type of selection. As a rule, the discharge is at least located near the back wall of the bag for ostomy use. In this case, the holes in the foil layer facing the front wall will be accessible for gas passage. The precipitates can also be located near the front wall, and in this case, the holes in the foil layer facing the rear wall will be accessible for gas passage.

Holes can be made by punching, burning and extruding, or using a laser, drill, needle or die cut. The number of holes can range from 1 hole for a bag for ileostomy use to more than 150 holes for a bag for colostomy use. The number of holes depends on the size of the filter structure and the type of discharge leaving the stoma.

It is contemplated that the filter structure of this invention will be used in combination with an ileostomy as well as a colostomy. The two types of stoma usually display different types of secretions. With an ileostomy, the discharge is usually more watery and more syrupy, while the discharge from the colostomy is usually more porridge. However, the type of discharge may also depend on food intake and liquids - therefore, in the future we will refer to watery discharge (from syrupy to liquid) and thick discharge (porridge-like), regardless of whether they come from an ileostomy or colostomy.

In the case of dense discharge, there is a risk that the openings acting as gas inlet openings will become clogged due to sticking of the discharge over the openings. Since the secretions have a relatively thick consistency, they may not completely pass through the hole. Consequently, the opening may be filled with secretions and thus cease to function as a gas inlet. In the case of watery discharge, the openings will not be filled with discharge and thus will not become clogged, since the discharge can pass through the openings. Therefore, a larger number of openings (gas inlet openings) are necessary for thick discharge, and not for watery discharge. For watery discharge, the number of holes (gas inlet openings) can be 2 or only 1 hole (gas inlet), while up to 150 holes (gas inlet openings) can be used for thick discharge. At least more than 50 openings (gas inlet openings) can be used for thick discharge.

Not only the number of holes, but also the size of the holes can depend on the type of discharge. The reason is that dense precipitates, most likely, cannot pass through the hole (gas inlet), since the diameter of these holes, as a rule, does not exceed 2 mm. On the other hand, a small hole will most likely not be able to stop watery discharge. Therefore, for watery discharge, a smaller number and larger size of the openings (gas inlet openings) are preferred, and for thick discharge, a larger number and smaller size of the openings (gas inlet openings) are preferred.

When the size of the holes is presented as the size of the diameter, the largest diameter of the hole is indicated if the hole is not round, but oval. If the hole has a more angular shape, then, as before, the largest “diameter” is indicated, which in this case can be the largest diagonal size of the hole.

In an embodiment of the invention, the first distance between two adjacent holes is such that the liquid cannot move from one hole to the neighboring hole during normal operation. In a related embodiment, the second distance from the deodorizing element to the nearest gas inlet is such that liquid cannot pass from the nearest gas inlet to the deodorizing element during normal operation.

In this application, when referring to the first distance between the openings or the second distance between the gas inlet openings and the deodorizing element, these distances are in the plane of the filter structure. Thus, the second distance is defined as the distance in the plane direction of the foil layers of the filter structure from the gas inlet closest to the deodorizing filter to the edge of the deodorizing filter closest to the same gas inlet. The direction in the plane is limited by the foil layers of the filter structure, so that each foil layer extends in the indicated plane.

For thick discharge, it is assumed that clogging of the filter structure occurs when all gas inlet openings are blocked by the discharge. The gas inlet openings may be blocked by a semi-solid material that adheres to the hole and thus blocks the hole. The first distance between adjacent openings and the second distance from the gas inlet openings to the deodorizing element ensures that the secretions that clog one hole cannot pass through the pre-filter material along the surface of the foil layer and into the next hole or deodorizing element and also clog them . A liquid and semi-solid substance entering the deodorizing element may deprive the element of its ability to deodorize intestinal gases. Tests have shown that if the first distance between two gas inlets or the second distance from the gas inlet to the deodorizing element exceeds 10 mm in the plane direction, then a semi-solid or liquid substance will not be able to move through the pre-filter material during normal operation. Similarly, these distances minimize the risk that emissions that adhere to the surface of the filter structure will block too many gas inlet openings.

An embodiment of the second distance is at least 5 mm. Only a small amount of liquid can get into the pre-filter due to the small holes in the layers of the foil of the filter structure, so in order to stop this liquid, only a small distance is required. However, the second distance can be approximately 3 cm. As before, the difference depends on watery and thick secretions. Dense discharge will not be able to go very far into the pre-filter, therefore, the second distance between the gas inlet openings and the deodorizing filter can be quite small, for example 5 mm. In one embodiment, the smallest distance between the deodorizing element and the gas inlet is greater than 15 mm. This ensures that a liquid or semi-solid does not enter the deodorizing element during normal use.

However, watery discharge can pass further through the pre-filter, therefore, the second distance between the gas inlet openings and the deodorizing filter must be greater, for example, at least 3 cm.

The third distance between the gas inlet openings and the edge of the filter structure may exceed 5 mm. When the gas inlet openings are located close to the edge of the filter structure, there is no adjacent opening in the direction of the edge. Therefore, in this case, the distance may be less.

The closed region of the foil layers, which limits the filter structure, can be equipped with a drain hole facing down and located in the bag for stomic use - that is, facing the bottom of the bag for stomic use. This drainage hole, facing the bottom, provides the ability to remove, in particular, watery discharge from the filter structure. The drainage hole may be equipped with a check valve, so that the discharge from the bag is prevented from entering the filter structure through this hole. The check valve is well known in the art and can, for example, be made in the form of a valve made of foil.

In one embodiment, the filter structure also includes a flange that surrounds the gas outlet. The filter flange may be a die cast flange. This filter flange serves to provide an element for welding the filter structure to the bag for ostomy use. Thus, the placement of the filter structure does not depend on the manufacture of the bag for ostomy use and can be performed either during the manufacture of the bag for ostomy use, or at any time after it. In addition, the filter flange is made of a substantially non-conductive material that is capable of absorbing heat. Therefore, heat from the welding process is not transferred to the filter structure. Thus, the filter structure can be made in the form of a finished element, including a pre-filter and a deodorizing filter, and subsequently welded to the bag without the risk that the foil layers and the pre-filter will be welded to each other.

The filter flange can be made of a material such as PE or EVA, both of which can be quickly welded to the bag for ostomy use. Welding can be carried out at a temperature of, for example, 160 ° C for approximately ½ second. The thickness of the flange should exceed approximately 0.5 mm so that it can absorb heat from welding in order to prevent welding of the foil layers and the pre-filter to each other. The upper limit of the thickness is regulated by the requirement for the invisibility of the bag - therefore, it should be less than about 1 mm.

The filter flange can be glued to the bag instead of being welded to it. This can be done with acrylate or hot melt adhesive.

The filter structure can also be welded directly to the bag for ostomy use, which means that the filter flange can be excluded from the structure. In this case, the deodorizing filter is welded directly to the bag, that is, the layer of foil that covers the deodorizing filter is welded to the front or rear wall of the bag for ostomy use.

In one embodiment, the foil layers covering the deodorizing filter can be made in the form of a structure of three layers of foil laminated to a deodorizing filter. In this case, the foil layers can be made of a barrier foil that is impermeable to gas and liquid, so that the gas and liquid cannot leave the filter in any other place than the gas outlet. The three-layer structure may consist of an outer layer of foil which is adapted to be welded to the layer of foil of the bag, an intermediate layer of foil adapted to function as an intermediate protective layer, and an inner layer of foil adapted to be laminated to a deodorizing filter . An intermediate layer protects the foil structure from punctures that can penetrate through the layers. Protective ability is provided by ensuring that the intermediate foil layer has a significantly higher melting point than the outer and inner layers of the foil. For example, the outer and inner layers of the foil may have a melting point of 80 ° C to 150 ° C and the intermediate layer in this situation may have a melting point in excess of 200 ° C. As an example, the outer and inner layers can be made of a copolymer of ethylene vinyl acetate (EVA) and polyethylene (EVAPE) and the intermediate layer can be made of polyamide (PA).

The described three-layer structure can be welded or laminated to the side of the deodorizing filter facing outward when placed in a bag for ostomy use. On the side facing the inside of the bag, it is less important to avoid punctures and ensure gas impermeability, since the gas will only enter the bag again for leakage through the layers of foil for ostomy use. However, the design of the three layers of foil, however, can also be used from the inside, which eliminates the need for separate layers of foil. In any case, gas leakage must be avoided.

When the foil layers described above are used as coating layers for a deodorizing filter, this filter itself can serve as a heat-absorbing flange, since the deodorizing filter is able to absorb heat from the welding process.

The pre-filter can be made of a porous material, for example, PE or polyurethane (PU). The pore size can be from 15 to 100 pores per inch, for example 30 or 45 pores per inch. The number of pores per inch is a pore size, although in fact this value refers to the number of pores per inch of a porous material. Felt, fluff, non-woven, or any other material may also be used. Gas (including solid and / or semi-solid waste products) enters the pre-filter through openings in the foil layers, which provide openings for the inlet of gas into the filter structure. Due to the tortuous structure of the porous material, most of the liquid and semi-solid waste products will be retained inside the porous material, so that only gas will pass through the porous material and reach the deodorizing filter.

The thickness of the pre-filter can be from 1 to 5 mm, for example about 2 or 3 mm. Thickness is defined as the linear dimension in the transverse direction of the filter structure corresponding to the linear dimension of the pre-filter in the direction from the first foil layer to the second foil layer.

The area of the pre-filter can be so large that it can almost be equal to the area of the front or back wall of the bag. However, leave room for manufacturing tolerances. The area of the pre-filter can be 10% of the area of the front or rear wall when viewed in the plane of the bag. This can happen when using a large bag, such as a max bag. In another embodiment, the area of the pre-filter may be up to 80 or 90% of the area of the front or back wall of the bag. This applies in particular to small bags, such as mini-bags.

Using a large pre-filter can be beneficial for bags filled with watery discharge, since it is difficult to completely prevent the ingress of watery discharge into the pre-filter. Thus, a large volume of porous material is necessary to prevent watery secretions from entering the deodorizing filter. The use of a large pre-filter can also be advantageous for bags filled with thick secretions, since a large number of gas inlets are necessary to ensure that at least some gas inlets are open. As mentioned earlier, if there are thick secretions in the bag, the gas inlet openings will be blocked due to sticking of the secretions to the inlet openings. Thus, if the bag is filled with thick secretions, a large area of the foil layer equipped with gas inlet openings is needed.

The gas outlet of the filter structure communicates with an air vent in the form of an opening or a slot in the bag for ostomy use, so that the gas leaving the gas outlet passes through the air vent and enters the environment or passes through a deodorizing filter, if located outside bag. Communication can be made by placing the gas outlet in line with the vent, or at least in the vicinity of the vent. The ventilation hole must be surrounded, for example, by a weld located around the ventilation hole, so that the gas in the bag is prevented from escaping from the ventilation hole bypassing the filter structure. As a rule, this can be achieved by welding the filter structure to the bag for ostomy use in the form of a continuous seam, so that the gas outlet and the ventilation hole are inside the boundaries of the weld.

In one embodiment of the invention, the filter structure also comprises a membrane located in the gas outlet. This membrane is gas permeable but impervious to moisture. The membrane can be microporous and hydrophobic and made of a material such as Gortex® or Tyvek®. The membrane should be able to provide a flow rate of from 100 to 550 ml / min with a pressure difference of 0.01 bar, for example 250 ml / min or 350 ml / min.

The membrane can be attached, for example, glued, to the surface of the deodorizing filter, that is, between the surface of the deodorizing filter and the “inner” surface of the second layer of foil. Alternatively, the membrane is located outside the second foil layer — that is, between the gas outlet and the vent on the bag.

Foil layers of the filter structure may surround the pre-filter, deodorizing filter and membrane.

In one embodiment, where the confined area includes a deodorizing filter, the pre-filter includes a cutout for the deodorizing filter. The cutout may be disk-shaped in order to match the disk-shaped deodorizing filter. The gas inlet openings are located near the periphery of the filter structure and the deodorizing filter comprises a gas inlet opening located along its periphery and an outlet opening located substantially in the center.

A pre-filter may be provided as an annular porous element. It may have a round or angular outer periphery. Part (for example, the central part) of the pre-filter is removed by punching or cutting a cut-out in the pre-filter, which leaves room for a deodorizing filter. Preferably, the cutout for the deodorizing filter substantially matches the outer contour of the deodorizing filter. If the deodorizing filter has a disk-like shape, then the cutout for the deodorizing filter is generally disk-shaped, and if the deodorizing filter has an angular or banana shape, then the cutout for the deodorizing filter will generally have this shape. Matching the cutout for the deodorizing filter to the deodorizing filter provides a more compact design. Gas entering the filter structure through gas inlets located on the periphery passes through the pre-filter towards the inner periphery of the pre-filter and from there into the deodorizing filter. The gas then passes laterally through the deodorizing filter and exits the filter structure through an opening in one of the foil layers, which provides a gas outlet.

A filtering structure like this one will be compact and easy to place anywhere inside the bag for ostomy use in accordance with production needs or technology.

In one embodiment, the pre-filter is located next to the deodorizing filter, so that they are located side by side inside the filter structure. In such a design, a deodorizing filter will be located at one end of the filter structure. In other words, the pre-filter and the deodorizing element can be arranged in series. Thus, the filter structure may have an elongated and preferably slightly curved shape, so that it can follow the contour of the bag for ostomy use. In one related embodiment, the pre-filter and the deodorizing filter are located on the same plane. Alternatively, a deodorizing filter is located on top of the pre-filter.

One embodiment of the invention relates to a filter structure comprising a viewing window that allows the user to inspect the stoma and possibly the peristomal region.

This inspection window can be located in the pre-filter, so that the pre-filter is a generally disk-shaped element containing a round hole, the diameter of which is at least equal to the diameter of the discharge inlet, where the layers of the filter construction foil are welded around the periphery of the round hole in the filter pre-cleaning.

To provide a transparent viewing window, the foil layers must be transparent or must be removed in the round hole.

In a related embodiment, the viewing window is offset from the center in the pre-filter and the deodorizing filter is located in a cutout for the deodorizing filter.

The inspection window can be positioned so that it leaves a thin strip of pre-filter above the inlet for the discharge and a large area with a cutout for the deodorizing filter below the inlet for the discharge. Thus, the deodorizing filter will be located below the discharge inlet. However, the inspection window can also be positioned so that a thin strip of pre-filter is located below the discharge inlet and a large area containing a cutout for the deodorizing filter and the deodorizing filter are located above the discharge inlet.

A viewing window allows the user to inspect the stoma and peristomal area from the outside of the device for stomic use. For this, part of the front wall of the bag must be transparent. The diameters of the individual parts in a particular embodiment may be: a deodorizing filter of 30 mm, a pre-filter of 110 mm, and a viewing window in the pre-filter of 70 mm.

In another embodiment, a viewing window may be provided because the pre-filter is banana-shaped and is located above the stoma and thus does not allow the stoma to be inspected. A pre-filter may be located above and, in part, around the waste inlet. This pre-filter may contain a circular hole in the middle of the banana shape in order to provide space for the deodorizing filter.

One embodiment of the invention relates to a filter shutter, as described in European patent EP1578308B1 in a device for stomy use according to this invention. This ensures that at too high a flow rate through the filter structure of the present invention, when the front and rear walls of the bag begin to fold towards each other, which leads to flattening, it is possible to partially or completely close the bag’s ventilation opening with the shutter described in the patent .

In a second aspect, the invention relates to a device for ostomy use, which comprises

a bag containing a front wall and a rear wall,

an inlet for discharge located in the rear wall in order to allow discharge from the stoma to enter the bag,

at least one vent for venting gas from the bag,

a filter structure comprising a first and second foil layer that define a closed region,

however, the filter structure is attached inside the bag, so that each layer of foil is essentially parallel to the front and rear walls of the bag, with the first layer of foil facing the rear wall and the second layer of foil facing the front wall of the bag,

wherein the filter structure comprises gas inlet openings located in at least one layer of the foil, and a gas discharge opening located in the second foil layer, adapted to communicate with the ventilation hole,

while the closed area contains a pre-filter.

A device for ostomy use with a filter structure, as described above, will be able to continuously remove gas from the bag. Providing gas inlets in one of the foil layers or in both layers provides constant routes through the pre-filter. In addition, the arrangement of the foil layers parallel to the front and rear walls helps to minimize the risk of overlapping openings for gas inlet emissions during operation.

In one embodiment, the ostomy appliance according to the second aspect of the invention comprises a deodorizing filter located within a closed area, so that the gas exiting the pre-filter comes directly to the deodorizing filter and from there passes through a gas outlet. The gas flow direction is defined as the distance at which gas flows from the gas inlets through the pre-filter, through the deodorizing filter, and out through the gas outlet and the vent.

In a bag for ostomy use according to a second aspect of the invention, the filter structure may include one or more carrying means attached to the foil layers of the bag in a step of the loop welding process.

Carrying means can be a separate or integral part of one or both layers of the foil of the filter structure; if they are made in the form of a separate part, then they can be attached to the layer (s) of the foil by welding or gluing. The carrying means may attach the filter structure to the bag contour for ostomy use at the top thereof, so that during operation, gravity helps to guide the filter structure down into the bag and maintain it in the desired position. The carrying means may also attach the filter structure in a lower position, if necessary.

This prevents the separation of the filter structure located inside the bag during operation. To some extent, the filter structure will still be able to wrinkle during operation. This is because the carrying means attaches only the top of the filter structure to the bag for ostomy use. Thus, the lower part of the filter structure can still be freely suspended.

In a third aspect of the invention, the invention relates to a device for ostomy use, which comprises

bag containing

front wall and rear wall

secretion inlet located in the rear wall to allow ostomy secretions to enter the bag

at least one vent for venting gas from the bag

a filter structure attached to the bag for ostomy use and containing a first layer of foil and a second layer of foil that define a closed area, while the closed area includes a pre-filter

a plurality of gas inlet openings located in at least one of the foil layers: the first and / or second

a gas outlet located in the second layer of the foil,

where the filter structure is adapted to collapse when filling the bag.

A device for ostomy use with a filter structure, as described above, will be able to continuously remove the gas that is contained in the bag. The location of the gas inlet openings in the foil layer (s) of the filter structure and the ability of the filter structure to wrinkle ensure that at least one inlet is always open, in particular when the bag is full or the bag swells. When the bag fills, the shape of the bag will change to a more swollen, longitudinal configuration. This means that the bottom of the bag may move slightly downward due to loading of the contents of the bag, and at the same time, or alternatively, the bag may be thicker in the axial direction (outward in the direction of the stoma). This leads to a decrease in width and will lead to crushing of the filter structure.

In an embodiment of the invention according to the first, second or third aspect, the filter structure is wrinkled when the bag is full, as a result of the relationship between the width of the filter structure and the width of the bag in the transverse direction.

By adapting the width of the filter structure in the transverse direction to the width of the bag in the transverse direction, crushing of the filter structure can be achieved when the bag is full. During operation, the configuration of the bag changes from one boundary configuration to another:

in the first configuration, the bag is not stretched and inflated

in the second configuration, the bag is stretched and / or inflated.

When filling the bag and while the filter is able to handle a certain amount of gas, the bag can take any configuration between the first and second configuration.

This means that in the first bag configuration, the width of the bag is essentially unchanged compared to the original width of the new unused bag. In the second bag configuration, the bag width is reduced compared to the original width of the new unused bag.

In an embodiment of the invention according to the first, second or third aspect, the width of the filter structure in the transverse direction is at least 100%, for example at least 80% or at least 60% of the width of the bag in the transverse direction.

It is assumed that the width of the filter structure is the largest width of the filter structure in the transverse direction in the plane of the foil layers. Similarly, the width of the bag is the largest width of the bag in the transverse direction, in the plane of the walls of the bag.

When the width of the filter structure matches the bag — and the filter structure goes inside the bag — the filter structure will take on a wavy shape or curl slightly as soon as it enters the bag. This will help provide access to the gas inlet (s) located on the surface of the filter structure.

It is assumed that in the second configuration of the bag, the width of the bag is reduced. By providing a width equal to at least 80% of the width of the bag, a filter structure is obtained that can be easily installed inside the bag, since the difference in width leaves space for attaching the filter structure to the front or rear wall of the bag and then attaching the front or rear wall to each other to a friend along their edge in any known manner. Thus, 80% provides manufacturing tolerances of the filter structure and bag, and at the same time provides a filter that can bend when the bag is full or inflated, since the width of the bag is reduced to less than 80% of the original width of the new unused bag.

By providing at least 60% of the width of the bag, the same effect is achieved - providing a little more space for manufacturing tolerances and providing a filter structure that will need a little more filling or swelling of the bag before it can bend.

In the second and third aspects of the invention, all other parts of the ostomy device and the filter structure may be as described above in the first aspect of the invention. For example, the device for ostomy use according to the second or third aspect of the invention may also include a deodorizing filter located inside the enclosed area, outside the bag, or between the closed area and the wall of the bag. Similarly, the device for ostomy use according to the second or third aspect may also comprise openings that function as gas inlets with a diameter of about 0.1-2.0 mm and in an amount of, for example, 2 for a bag for ileostomy use and up to more than 150 for a bag for colostomy use. Similarly, in the device for ostomy use according to the second or third aspect of the invention, the device for ostomy use, the distance between the gas inlet openings and between the gas inlet openings and the deodorizing filter, the filter flange, welding the filter structure to the bag wall, pre-filter, deodorizing filter, gas and ventilation outlet, membrane, the presence of various parts of the filter structure, including their relative position and A motor window can be provided as described above.

A particularly interesting embodiment of the invention relates to a device for ostomy use according to the first, second or third aspect, and

where the diameter of the gas inlet openings is at least 1 mm, for example about 2 mm, and

where the area of the pre-filter exceeds 40% of the area of the back wall.

Such a device for ostomy use is particularly suitable for use with an ileostomy because it contains new, large openings and a large area of the pre-filter. Thus, it exploits the fact that it is not possible to prevent watery discharge from entering the pre-filter, but the pre-filter is large enough to contain them within the normal time of carrying bags for ileostomy use. Large openings (almost completely) prevent clogging of the holes with watery discharge from the ileostomy due to adhesion of the discharge to the holes.

By providing a pre-filter area of more than 40% of the rear wall area, an adequate amount of porous material is provided, even if the thickness of the porous material is only 5 mm. Nevertheless, this leaves a sufficient volume of porous material, so that the pre-filter is able to process the amount of liquid that enters the pre-filter.

Another interesting embodiment of the invention relates to a device for ostomy use according to the first, second or third aspect and

where the number of gas inlet openings exceeds 50 and these openings are located in both the first and second foil layer,

where the gas inlet openings comprise openings with a diameter of less than 1 mm, for example about 0.5 mm, and also openings with a diameter of about 1 mm or more, for example about 2 mm.

Such a device for ostomy use is especially suitable for use with a colostomy, since most of the discharge coming out of the colostomy is quite thick and thus, as described above, the filter structure will be clogged, since the discharge sticks to the surface of the filter structure - therefore, the number of holes should be large and they should be located in both layers of the foil in order to prevent clogging of all openings. In addition, the discharge leaving the colostomy may also contain less dense discharge - therefore, it is preferable to provide different diameters of the gas inlet openings.

In a fourth aspect of the invention, the invention relates to a method for collecting ostomy secretions in an ostomy device that comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed area, the closed area including a pre-filter, where a plurality of gas inlets are located in at least one layer of the foil and a gas outlet is located in the second layer of the foil, while the filter structure is secured insulated inside the bag so that the main part of the filter structure is freely suspended in the bag, the method comprising placing the device around the stoma.

In one embodiment, the implementation of the bag contains a ventilation hole and the filter structure is arranged so that the gas outlet for the filter structure communicates with the ventilation hole of the bag.

A fifth aspect relates to a device for ostomy use, which comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed region, wherein the closed region includes a pre-filter where a plurality of gas inlets are located at least in one layer of the foil and a gas outlet is located in the second layer of the foil, while the filter structure is attached inside the bag so that the main part of the filter Design is freely suspended in a bag, for use in a method for collecting exudates from the stoma, which method comprises positioning devices around the stoma.

In one embodiment, the implementation of the bag contains a ventilation hole and the filter structure is arranged so that the gas outlet for the filter structure communicates with the ventilation hole of the bag.

In an embodiment of the aforementioned fourth and fifth aspect, stoma isolation is collected at night.

The method and device for ostomy use, as described in the fourth and fifth aspect, allows the user to sleep for most of the night, as he will not be disturbed by the bloating of the bag for ostomy use.

In a sixth aspect of the invention, the invention relates to a method for reducing the amount of blistering that occurs in an ostomy device that comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed area, the closed area including a pre-filter where a plurality of gas inlets are located in at least one foil layer and a gas outlet is located in the second foil layer, while filtering The structure is attached inside the bag so that the main part of the filter structure is freely suspended in the bag, the method comprising placing devices for stomic use around the stoma.

In a seventh aspect of the invention, the invention relates to an apparatus for ostomy use, which comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed area, the closed area including a pre-filter with a plurality of gas inlet openings in at least one layer of the foil, a gas outlet is located in the second layer of the foil, while the filter structure is attached inside the bag so that the main part of the filter structure is freely suspended in the bag, for use in the method of reducing the amount of swelling that occurs in the device for ostomy use, the method comprising placing the device for ostomy use around the stoma.

Clinical trials have shown that devices for ostomy use according to this invention can reduce the occurrence of blisters by more than 50% - see the paragraph below. This means that the user will be less concerned about swelling when wearing the device for ostomy use according to this invention, which reduces the number of embarrassing situations and the separation of the bag from the plate or the separation of the device from the user's skin.

In an eighth aspect of the invention, the invention relates to a method for increasing the time before bloating occurs in an ostomy use device, which comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed area, the closed area including a pre-filter, where a plurality of gas inlets are located in at least one foil layer and a gas outlet is located in a second foil layer, wherein the filter schaya structure is attached inside the bag so that the main part of the filter design is freely suspended in a bag, the method comprises positioning means for stomicheskogo use around the stoma.

In a ninth aspect of the invention, the invention relates to an apparatus for ostomy use, which comprises a bag and a filter structure comprising a first foil layer and a second foil layer defining a closed region, the closed region including a pre-filter where a plurality of gas inlet openings are located in at least one layer of the foil, a gas outlet is located in the second layer of the foil, while the filter structure is attached inside the bag so that the main part of the filter structure is freely suspended in the bag, for use in the method of increasing the time before the occurrence of swelling in the device for ostomy use, the method comprising placing the device for ostomy use around the stoma.

Clinical trials have shown that devices for ostomy use according to this invention can increase the time before bloating by more than 70% - see the paragraph below. This means that the user will be able to wear the device for ostomy according to the invention for a longer time without experiencing problems associated with bloating. This can result in a better and more continuous sleep, since the user does not have to let out air from the device for ostomy use.

In one embodiment of the sixth, seventh, eighth or ninth aspect of the invention, an ostomy device is located around the colostomy and the first and second foil layers comprise more than 50 gas inlets. The number of gas inlet openings for use with a colostomy can also exceed 75, for example, exceed 100, and even exceed 150 openings.

In another embodiment of the sixth, seventh, eighth or ninth aspect of the invention, an ostomy device is located around the ileostomy and at least one layer of foil contains at least one gas inlet at least 1 mm in diameter and a pre-filter It has a sufficiently large volume to handle liquid secretions entering the pre-filter during the normal wearing period. The number of gas inlet openings in this embodiment may be 2 openings.

A sufficiently large volume for processing liquid precipitates 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 structure is at least 40% of the area of the back wall.

Other aspects of the device for ostomy use, as described above, can also be combined with aspects of the invention No. 4-9.

Clinical trials

Devices for ostomy use, as described above, were tested by users with a colostomy (20 users) and users with an ileostomy (20 users). The tests were compared with standard devices for ostomy use, containing two filter structures, each of which contains a pre-filter of porous material 50 mm × 10 mm × 3 mm and a deodorizing filter of carbonized foam 30 mm × 7 mm × 3 mm. The study was conducted as an open cross-sectional random sampling study. All users used integral devices for ostomy use and should have experienced bloating problems at least once a week. Users were instructed to change the device for ostomy use in case of bloating, and in other cases to replace the device according to the usual schedule.

Both types of users noted an increase in the time before blistering and a decrease in the number of blisters.

For users with a colostomy, the number of tested reference devices for ostomy use was 567 devices and the number of devices for ostomy use according to this invention was 526 devices. The number of blisters in the reference devices was 129 and the number of blisters in the devices according to this invention was 59. Thus, the number of blisters that occurred in the devices according to this invention decreased by 52%.

For users with an ileostomy, the number of tested standard devices for ostomy use was 294 devices and the number of devices for ostomy use according to this invention was 283 devices. The number of blisters in the reference devices was 161 and the number of blisters in the devices according to this invention was 74. Thus, the number of blisters that occurred in the devices according to this invention decreased by 62%.

For users with a colostomy who tested the reference fixtures, on average, bloating occurred approximately every 1.5 days (0.72 bloating / per user / per day). When the same users tested the devices for ostomy according to this invention, on average, bloating occurred on approximately every fourth day (0.26 bloating / per user / per day). Thus, the time before the onset of bloating increased by 74%.

For users with an ileostomy who tested reference devices, on average, bloating occurred almost every day (0.90 swelling / per user / per day). When the same users tested the devices for ostomy according to this invention, on average, bloating occurred on approximately every third day (0.34 bloating / per user / per day). Thus, the time before the onset of bloating increased by 82%.

Example - Filter Design Test

The test was carried out using a filter test apparatus that can hold a bag for ostomy use (= device for ostomy use) while monitoring pressure and air flow. The device includes a differential pressure gauge for monitoring pressure and a flow regulator for monitoring air flow. Additionally, the device can simulate bag filter contamination for ostomy use. The filter tester performs controlled massaging and shaking of the ostomy bag containing simulated discharge from a colostomy or ileostomy. Simulated discharge from a colostomy has a porridge-like consistency and simulated discharge from an ileostomy has a syrupy consistency.

The test was carried out by installing a bag for ostomy use containing a simulated colostomy discharge medium in a filter test device. Then the bag for ostomy use was inflated to a pressure of 10 mbar. When the pressure stabilized at 10 mbar, the flow through the uncontaminated filter structure was determined by the value indicated on the flow regulator.

After an uncontaminated flow was noted, air was released from the ostomy bag and the first contamination cycle was carried out by allowing the massage plate to move forward to the ostomy bag and massaging the ostomy bag containing discharge, resulting in controlled contamination of the surfaces inside a bag for ostomy use, including a filter design.

After the cycle was completed, the ostomy bag was again inflated to 10 mbar and the flow through the filter structure was determined as described above.

This stage of contamination was repeated until blockage of the filter structure was achieved. The flow through the filter structure was determined at a pressure of 10 mbar for each contamination cycle.

Various test sequences have been conducted.

In a first test sequence, bags for ostomy use with a filter structure according to this invention were tested and compared with bags for ostomy use with a reference filter structure. The filter structure according to this invention contained a pre-filter having a generally circular periphery with a diameter of about 110 mm and containing a viewing hole with a diameter of about 60 mm cut in the center. The filter structure also contains an opening for a deodorizing element with a diameter of about 30 mm located at the bottom of the pre-filter. The reference filter construction includes a pre-filter of porous material with a size of 50 mm × 10 mm × 3 mm and a deodorizing filter of carbonized foam material with a size of 30 mm × 7 mm × 3 mm.

Ostomy bags according to the invention are of two different types. In sequence 1.1, the bags for ostomy use were bags adapted for use with a colostomy, and thus contained 96 openings serving as gas inlets. The holes were made using a needle with a diameter of less than 1 mm; approximately 0.5 mm. Among the holes there were 6 holes with a diameter of approximately 1 mm. Four bags for ostomy use according to the invention and five reference bags were tested in this sequence. All bags (samples and reference) were filled with test medium, which is comparable to the porridge discharge mentioned earlier. Table 1 below shows the number of contamination cycles that each bag was subjected to before stopping flow through the bag.

Table 1 Ostomy bag Colostomy sample 1 Colostomy Sample 2 Colostomy Sample 3 Colostomy Sample 4 Pollution cycles eleven 9 fifteen 16 Ostomy bag reference 1 reference 2 standard 3 reference 4 standard 5 Pollution cycles 2 one one one 2

From table 1 above, it became known that bags for ostomy use according to this invention (from sample 1 to sample 4) and filled with secretions similar to those from a colostomy significantly exceed the characteristics of reference bags (from standard 1 to standard 5). On average, bags for ostomy use according to this invention withstood 13 cycles of contamination, compared to 1-2 cycles for reference bags.

Sequence 1.2 contains bags for ostomy use according to the invention and adapted for use with an ileostomy. Thus, these bags contained 2 holes with a diameter of approximately 1 mm, performing the function of gas inlet openings. Four bags for ostomy use according to the invention and five reference bags were tested in this sequence. All bags (samples and reference) were filled with test medium, which is comparable to the syrupy discharge mentioned earlier. Table 2 below shows the number of contamination cycles that each bag was subjected to before stopping flow through the bag.

table 2 Ostomy bag Ileostomy sample 1 Ileostomy sample 2 Ileostomy sample 3 Ileostomy sample 4 Pollution cycles 12 13 eleven 12 Ostomy bag reference 1 reference 2 standard 3 reference 4 standard 5 Pollution cycles one one one one one

From table 2 above, it became known that bags for ostomy use according to this invention (from sample 1 to sample 4) and filled with secretions similar to those from the ileostomy significantly exceed the characteristics of the reference bag (from reference 1 to reference 5). On average, bags for ostomy use according to this invention withstood 12 cycles of contamination, compared with only 1 cycle for a reference bag.

The second test sequence relates to the effect of hole size. Only bags for ileostomy use were tested in this sequence, since the discharge from the colostomy may contain both liquid and thick discharge. Therefore, the effect of the size of the holes is more important to test for bags containing only watery discharge. In sequence 2.1, bags for ileostomy use with 2 mm diameter openings were tested. These results were compared with sequence 2.2 containing bags for ileostomy use with openings of 1 mm diameter. Table 3 below shows the results of two of these test sequences.

The results shown in table 3 above demonstrate that holes with a diameter of 1 mm are less preferred than holes with a diameter of 2 mm. The reason may be that watery discharge may be able to clog smaller openings (1 mm in diameter) and since the filter structure contains only 2 gas inlet openings, it is very important that both openings remain open. Holes with a diameter of 2 mm will not be clogged with watery discharge. In addition, a large pre-filter is able to process (contain) emissions that fall into the pre-filter for at least about 9 cycles (sequence 2.1).

Detailed description of graphic material

1 shows a device for ostomy use 1 according to one embodiment of the invention. The device for ostomy use contains a bag containing a rear wall 2 and a front wall 3, which are welded to each other along its edge (not shown). The rear wall 2 contains an inlet for secretions 4, which in this embodiment is surrounded by adhesive 5 that does not irritate the skin, so this is the so-called one-piece device. The ostomy 6 is also shown. The filter structure 10 in the device for ostomy use contains a first layer of foil 11 and a second layer of foil 12 welded together along their outer contour 13. The layers of foil 11, 12 contain many holes 14 that act as openings for gas inlet to the filter design 10. The pre-filter 15 in this embodiment is a generally annular element with a cutout 16 for the deodorizing filter 17. The deodorizing filter 17 in this embodiment yaet a disk-shaped member. The deodorizing filter 17 is enclosed in foil layers 18, 19, impervious to gas and liquid. These foil layers 18, 19 are welded or glued to the foil layers 11, 12, enclosing the entire filter structure 10, and, in addition, are welded or glued to the surfaces of the deodorizing filter 17. Thus, the gas flow passing in the filter structure is forced flow through the deodorizing filter from the periphery to the center. The filter structure 10 also includes a membrane 20 located in the central part of the deodorizing filter 17 so as to close the gas outlet 22 from the filter structure. In this embodiment, the gas outlet 22 is surrounded by a flange of the filter 21, which is permanently attached to the filter structure 10 and welded to the device for ostomy use 1. Thus, the filter structure 10 is connected to the device for ostomy use 1. The gas outlet 22 deodorized gas to the external environment through the vent 23 in the front wall 3 of the bag. The scale of the graphic material differs from the real scale.

Figures 2 and 3 show another embodiment of a device for ostomy use 101 according to the invention. Figure 2 shows a rear view of the device for ostomy use 101 and figure 3 shows a view in cross section. A device for ostomy use 101 may be provided in at least three sizes, MINI, MIDI and MAXI (as shown in FIG. 2). Three sizes are shown to illustrate the comparative size relationship between the filter structure 110 and the ostomy fixture 101 for these three sizes. This embodiment differs from the embodiment of FIG. 1 in that the pre-filter 115 comprises a viewing window 125 that is large enough to inspect the stoma 6 and the area immediately around the stoma 6. The viewing window 125 is made of the same layers of foil 111, 112, which are used to enclose the filter structure 110 within itself, which is possible because the layers of foil 111, 112 in this embodiment are transparent. Thus, the viewing window 125 is made by welding the layers of foil together in a circle 126 so as to prevent any substance in the filter structure from getting inside the viewing window 125 and blocking the viewing substance with this substance. It should be understood that the filter design of the present invention can also be implemented in other sizes, types and shapes of waste bags for waste.

A plurality of gas inlet openings 114 to the filter structure are generally arranged around the viewing window 125. The lower part of the pre-filter 115 includes a cutout 116 for the deodorizing filter 117. The deodorizing filter 117 is enclosed in foil layers 118, 119 so as to ensure a forced gas flow in transverse direction through the deodorizing filter from the periphery to the center, as in the embodiment of FIG. 1. As with the filter structure of FIG. 1, this filter structure 110 also includes a membrane 120. The filter structure 110 can be permanently attached to the bag by welding the filter flange 121 to the front wall of the bag, as described in FIG.

The filter structure 110 is also equipped with foil carrying means 130, 131. These carrying means 130, 131 may be welded to the edge of the bag and assist in carrying and adjusting the position of the filter structure 110.

FIG. 4 is an exploded view of the filter structure 110 of FIG. 2 and 3 - however, carrying means for adjusting the filter structure are not shown. The filter structure 110 comprises a filter flange 121, a membrane 120, a second layer of foil 112 with a plurality of openings providing gas inlets 114, a pre-filter 115 of porous material with a cutout 116 for a deodorizing filter, a deodorizing filter 117 with a foil layer 118 at the top, and a second a layer of foil 119, so that the layers of foil 118, 119 together enclose a deodorizing filter and, finally, the first layer of foil 111, which also contains many holes that act as gas inlets 114. The location of the holes fulfills the above requirements for the distances between the holes.

Figure 5 shows the device for ostomy use 201 according to the invention, where the pre-filter 215 in the filter structure 210 has a generally banana shape and is located above the inlet 204 for waste. The pre-filter contains the first 211 and second 212 layers of foil, which during production form part of the large segments of the foil 241, 242. Two large segments of the foil 241, 242 extend from the upper edge 243 to the lower edge 244. The upper edge 243 is located above the upper edge of the bag for ostomy use 201 and extends below the lower edge of the filter structure 210. Similarly, large segments of foil 241, 242 extend beyond the sides of the bag. In these large sections of foil 241, 242, the filter structure 210, comprising an inspection window 225, is made by welding the foil layers on the inner periphery 226 of the pre-filter (inner curved side of the banana shape) along the lower edges 227, 228 of the pre-filter and on the outer periphery 229 pre-filter (external curved side of a banana shape). Holes 245 are used to adjust the filter structure during production. When it is necessary to manufacture the fixture 201, this finished filter construction is attached to the front wall or back wall during the separate welding process or to the front and rear wall when welding the bag edge.

Foil segments, such as those depicted in FIG. 5, can also be used to make the embodiments of FIG. 1-4.

6 shows a filter structure 310 that is equipped with a drain hole 350. The drain hole 350 includes a check valve 351 with two foil shutters 352, 353 that provide a one-way path from the filter structure 310. In normal use, when the filter structure is positioned in this way, With the drain hole 350 facing downward, the liquid discharges in the filter structure 310 will move to the drain hole 350 and exit through the check valve 351 and into the bag. Due to the one-way function of the valve 350, the passage of liquid secretions in the bag through the valve 350 and into the filter structure 310 will be prevented.

7 shows a part of the filter structure 410, in which the deodorizing filter 417 is enclosed in a structure of three layers of foil 418, 410. FIG. 7A shows a part of the filter structure and FIG. 7B shows three layers constituting the layers of foil 418 and 419. The three-layer foil structure comprises an outer layer 419a, an intermediate layer 419b and an inner layer 419c. The outer layer 419a (outward from the deodorizing filter) and the inner layer 419c (inward to 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 previously, the foil structure 419 facing the gas outlet must be impermeable to liquid and gas, while the foil structure 418 may not be impermeable to gas, since during operation it is facing inward in the bag. On figa shows a portion of the filter structure 410, which contains a pre-filter 415 and layers of foil 411, 412, which enclose a filter structure. The gas outlet 422 from the deodorizing filter may be closed by a membrane 420, as shown in the figure. The foil structure 419 may be welded to the front wall 403 of the bag.

On Fig shows a device for ostomy use 501 according to the invention. A device for ostomy use 501 is depicted in FIG. 8 in a first configuration when the bag is not stretched and inflated. The device for ostomy use 501 comprises a filter structure 510 according to the invention. The width b of the filter structure is at least 60% (preferably at least 80%) of the width B of the bag in the first bag configuration. In this context, the width refers to the linear dimension in the transverse direction of the bag. Both widths are measured from the border furthest from the center on one side to the border furthest from the center in the transverse direction of the bag (or filter structure).

Figure 9 shows the device for ostomy use 501 according to the invention, depicted in the second configuration when the bag is stretched or inflated. As can be seen in the figure, the width B 'of the bag in this configuration has been reduced, so that it is now smaller than the width b of the filter structure.

Figure 10 shows another filter structure 610 according to the invention. The filter structure comprises a first layer of foil 611 and a second layer of foil 612. A preliminary filter 615 of porous material is enclosed in the layers of the foil. Two layers of foil 611, 612 are provided with openings for gas inlet 614 in the form of holes. The filtering structure 610 also contains a deodorizing filter 617. The figure shows that the discharge 640, which fell inside the pre-filter 615, pass only a certain distance inside the pre-filter. Therefore, if the gas inlet openings 614 are located with a distance between each other exceeding the maximum penetration depth of the secretions, then the secretions will not be able to move from one gas inlet to the adjacent gas inlet.

11 is a schematic drawing of a filter testing apparatus 1000, which was used in the above example. The filter testing apparatus 1000 includes a flow regulator 1001 for measuring the flow passing through the filter structure and a differential pressure meter 1002 for measuring the pressure in the bag for stomic use. Such a flow regulator and pressure meter are well known in the art. The filter test unit 1003 is a control unit capable of controlled massaging and shaking of the bag for ostomy use. The ostomy bag (not shown) is held during the test in a tripod 1004 for the ostomy bag, which includes a holder 1005, 1006 on both sides of the bag. The filter test unit 1003 controls the massage plate 1007 to provide controlled massaging of the bag.

12 and 13 show the results of test sequence No. 1. Figure 12 shows the test results of bags for colostomy use - corresponding to the test sequence 1.1 described above - and figure 13 shows the test results of bags for ileostomy use - corresponding to the test sequence 1.2 described above. The difference between ostomy bags according to the invention and ostomy bags equipped with standard filters (described above) is obvious. In both figures, the dotted lines from the dots depict the test results of bags for ostomy use according to the invention and the dotted lines from the dashes (left in the figures) represent the test results of bags for ostomy use with standard filters. The solid lines between the dotted lines of dots and dashes represent the average values. In Fig. 13, only the midline for the standard filter is visible, since all filters withstood only 1 cycle. Thus, for bags for colostomy use, FIG. 12 shows that the bag for ostomy use according to the invention withstands an average of 13 cycles of contamination before the flow rate through the bag drops below an acceptable level. This must be compared with the average value for a bag for ostomy use with a standard filter that withstands only 1-2 cycles. For bags for ileostomy use, FIG. 13 shows that the bag for ostomy use according to the invention withstands 12 cycles on average. An ostomy bag with a standard filter lasts only 1 cycle on average.

On Fig shows the test results corresponding to the above test sequence 2. On Fig shows that the use of holes with a diameter of only 1 mm (dashed line of dashes) has a negative effect on the bags for ileostomy use. The flow weakens faster and the bags withstand less than the bags with holes with a diameter of 2 mm (solid line).

Claims (23)

1. Device for ostomy use, which contains
- a bag containing a front wall and a rear wall,
- an inlet for discharge located in the rear wall in order to allow discharge from the stoma to enter the bag,
at least one vent for venting gas from the bag,
- a filter structure comprising a first and second layer of foil that define a closed area,
wherein the filter structure is attached inside the bag, so that each layer of foil is substantially parallel to the front and rear walls of the bag, with the first layer of foil facing the back wall and the second layer of foil facing the front wall of the bag, with the filter structure provided with gas inlets located at least in the second layer of the foil, and the hole for the release of gas in the second layer of the foil, located in line with the ventilation hole,
while the closed area contains a pre-filter,
the number of gas inlet openings exceeds 50 and these openings are provided in both the first and second foil layer. 2. The device for ostomy use according to claim 1, wherein the filtering structure comprises a deodorizing filter inside a closed area. 3. The device for ostomy use according to claim 1 or 2, where the openings that perform the function of the gas inlet openings are provided both in the first foil layer and in the second foil layer. 4. The device for ostomy use according to claim 3, wherein the number of gas inlet openings exceeds 50, for example, exceeds 75, for example, exceeds 100, for example, exceeds 150. 5. The device for ostomy use according to claim 1, wherein the gas inlet openings comprise openings with a diameter of less than 1 mm, for example 0.5 mm, and also openings with a diameter of 1 mm or more, for example 2 mm. 6. The device for ostomy use according to claim 1, wherein the number of gas inlet openings is 2. 7. A device for ostomy use according to claim 1, wherein the diameter of the gas inlet openings is at least 1 mm, for example 2 mm, and where the area of the pre-filter exceeds 40% of the area of the back wall. 8. The device for ostomy use according to claim 1, wherein the area of the pre-filter is at least 20% of the area of the bag when viewed in the plane of the bag. 9. The ostomy appliance according to claim 1, wherein the filter structure is wrinkled when the bag is full, as a result of the relationship between the width of the filter structure and the width of the bag in the transverse direction. 10. The device for ostomy according to claim 9, wherein the width of the filter structure in the transverse direction is at least 100%, for example at least 80% or at least 60% of the width of the bag in the transverse direction. 11. The ostomy appliance of claim 1, wherein the diameter of the gas inlet openings is at least 1 mm and where the area of the pre-filter exceeds 40% of the area of the back wall. 12. The device for ostomy use according to claim 1, wherein the first distance between two adjacent gas inlet openings is such that the liquid cannot move from one opening to the adjacent opening during normal operation, wherein the first distance exceeds 10 mm. 13. The device for ostomy according to claim 2, wherein the second distance from the deodorizing filter to the nearest gas inlet is such that the liquid cannot pass from the nearest gas inlet to the deodorizing filter during normal operation, the second distance exceeding 15 mm 14. The device for ostomy use according to claim 1, wherein the third distance between the gas inlet openings and the edge of the filter structure may exceed 5 mm. 15. The device for ostomy use according to claim 1, wherein the enclosed region of the filter structure comprises a drainage hole facing downward in the device for ostomy use. 16. The device for ostomy use according to claim 15, where the drainage hole contains a check valve. 17. The device for ostomy use according to claim 2, where the pre-filter contains a cutout for a deodorizing filter. 18. The device for ostomy according to claim 17, wherein the cutout for the deodorizing filter is disk-shaped in order to match the disk-shaped deodorizing filter, and where the deodorizing filter comprises a gas inlet at the periphery of the deodorizing filter and a gas outlet located at being in the center. 19. The ostomy appliance of claim 17, wherein the cutout for the deodorizing filter has a banana shape to match the banana deodorizing filter, and where the deodorizing filter has a gas inlet at one end of the deodorizing filter and a gas outlet at the other the end. 20. The device for ostomy use according to claim 1, wherein the filter structure includes a viewing window that allows the user to inspect the stoma and peristomal region. 21. The device for ostomy use according to claim 1, wherein the filtering structure comprises one or more carrying means attached to the front and / or rear wall at the stage of the circuit welding process. 22. A method of reducing the amount of blistering occurring in the device for ostomy use, which contains a bag and a filter structure comprising a first layer of foil and a second layer of foil defining a closed area, while the closed area includes a pre-filter with a plurality of inlet openings gas is provided in at least one layer of the foil and a gas outlet is provided in the second layer of the foil, while the filter structure is attached inside the bag so that main part of the filter design is freely suspended in the bag, the method comprising the placement of devices for use stomicheskogo around the stoma. 23. A method of increasing the time before bloating occurs in the device for ostomy use, which comprises a bag and a filter structure comprising a first layer of foil and a second layer of foil defining a closed area, wherein the closed area includes a pre-filter with a plurality of inlet openings gas is provided in at least one layer of the foil and a gas outlet is provided in the second layer of the foil, the filter structure being attached inside the bag in this way that the main part of the filter structure is freely suspended in the bag, the method comprising placing devices for stomic use around the stoma.

Images