DK174421B1 - Flange for medical collecting bag used in surgery for number of diseases in gastro-intestinal tract - Google Patents

Abstract

The flange has an aperture allowing body fluids or exudates to enter the bag and has an inner rim delimiting the aperture. A central area encircles the aperture which has a predetermined weakening line pattern whereby the force needed for removing the bag flange from the body or skin or a body side member is smaller than the force needed for breaking the weakening line. Independent claims are also included for a medical appliance, and a medical collecting bag.

Description

DK 174421 B1

An ostomy appliance

The present invention relates to an ostomy device comprising a skin plate comprising an adhesive plate for securing the device to the patient's skin, said plate or pad having an opening for receiving an ostomy and a separate interchangeable collection bag attached to the ostomy skin plate for receiving secretions from the ostomy, wherein the skin plate contains first coupling means which are firmly connected to the base plate, and the collection bag comprises corresponding second coupling means suitable for releasable coupling and sealing to the skin plate.

In the case of surgical treatment of a variety of diseases of the gastrointestinal system, in many cases, the colon, ileum or urethra is surgically released and the patient is left with a stoma on the abdomen and the effluent or waste products that are brought through these organs, discharges through the artificial mouth or opening and is collected in a collection bag which is usually adhered to the skin by means of an adhesive plate or disc having an inlet opening for receiving the ostomy. Also in connection with a fistula which has developed between an internal organ and the surface of the abdomen, the patient must rely on a device to collect the body material which emerges from such an opening.

Ophthalmic devices are well known. Such devices may be two-piece or 20-piece devices. In both types of devices, a skin plate is attached to the user's abdomen, and optionally, a collecting device or bag is attached to the ostomy skin plate to collect exudates from the ostomy in the case of two-piece devices.

When one-piece devices are used, the entire device, including the adhesive plate or pad securing the device to the skin, is removed and replaced with a fresh device. When two-piece devices are used, the ostomy skin plate is left in place for several days and only the collection device or bag is replaced.

The duration of use of the ostomy skin depends on the amount and aggressiveness of the exudates and on the density between the ostomy and the skin plate.

DK 174421 B1 2

The life of the ostomy appliances can be reduced for several reasons. Due to the aggressiveness of the exudates, the adhesive material in the adhesive plate can be broken down and give the exudates access to the skin. This may require a replacement of the device to protect the skin. Furthermore, a leak around the stoma can cause the appearance of unpleasant materials or odors at the patient's abdomen, which can cause skin problems as well as embarrassing situations. In order to increase the useful life of the ostomy devices, it is proposed to adapt the size of the adhesive plate to the size of the ostomy concerned. One-piece ostomy devices and base plates for two-piece ostomy devices are usually provided with adhesive plates, with a number of aperture sizes for better adaptation to the size of the ostomy concerned, and the adhesive plate is often provided with a cutting guide to facilitate a more accurate fit using e.g. a scissor.

GB Patent Application No. 2,017,501 discloses a device for sealing an ostomy bag against a patient's skin, which device includes a sheet of material which can be adhered to the patient's skin and with a slit or incision extending like a spiral or the like. . An opening can then be made in the plate by rolling out the coil defined by the slot. The plate may be of a gelatinous material based on Karaya rubber and / or other hydrophilic materials.

The devices disclosed in GB patent application No. 2 017 501 are 20 one-piece devices.

U.S. Patent No. 3,604,421 discloses a one-piece disposable bag having a variable aperture size surrounded by separate concentric annular strips which can be removed to form a variable diameter aperture. U.S. Pat.

3,604,421 is silent on the problems associated with removal of the entire bag when the bag is replaced. However, in connection with two-piece devices, the size of the aperture for accommodating an ostomy in the bag flange is often greater than the aperture size of the commonly used baseplates, and there is a significant risk that the non-exudate accesses the distal surface of the baseplate adhesive plate. This opens the possibility of chemical attack on the adhesive from the "back" and may also cause contamination or contamination of the distal surface of the baseplate, especially in connection with colostomies. This can reduce the wear time of the baseplate and may also cause problems with replacing the collection bag with a new one, as the clutch area may need to be cleaned to ensure a proper coupling and sealing of the new bag and also to ensure that residues that give rise to unpleasant odors are not left on the base plate. considerable risk of having to replace the base plate before its technical use has been exhausted.

It has been found that these deficiencies can be remedied by the present invention.

In a first aspect, the invention relates to an ostomy device comprising a skin plate comprising an adhesive plate for attaching the device to a patient's skin, said plate having an opening for receiving an ostomy and a separate interchangeable collecting bag with a bag flange having an opening for receiving an ostomy, 15 wherein the skin plate contains first coupling means firmly connected to the base plate and the collecting bag contains corresponding second coupling means adapted for releasable coupling and sealing to the skin plate.

The invention further relates to an ostomy collection bag having a bag flange having an opening for receiving an ostomy wherein the bag contains coupling means for releasable coupling and sealing to corresponding coupling means firmly connected to a base plate containing an adhesive plate for attaching the base plate to a patient's skin, which plate has an opening for receiving a stoma, wherein the bag flange has an inner rim defining the opening therein and a central region, which region has a predetermined weakening pattern.

Further, the invention relates to a flange for an ostomy collection bag containing a substantially annular flange which can be connected to the collection bag via a substantially annular junction section and is intended for releasable and adhesive connection with a flange connected to a skin plate.

DK 174421 B1 4

The invention is illustrated in more detail with reference to the drawings in which

Figure 1 shows an embodiment of a collection bag according to the invention with a flange having a predetermined line of weakening in the form of a spiral,

Figure 2 is a cross-sectional view of the embodiment shown in Figure 1 along the line A-A; Figure 3 is a side view of the embodiment shown in Figure 1;

Figure 4 shows the embodiment shown in Figure 1 with a part of the coil detached from the flange,

Figure 5 shows another embodiment of a flange for a collection bag according to the invention with a predetermined concentric line of weakening,

Figure 6 shows a further embodiment of a flange for a collection bag according to the invention with a predetermined line of weakening in the form of a combination of helical and radial lines,

Figure 7 shows another embodiment of a collection bag according to the invention with a flange having a predetermined weakening line in the form of a coil and a coupling means. Figure 8 is a cross-section of the embodiment shown in Figure 7 along line B-B, and

Figure 9 shows yet another embodiment of a flange for a collection bag according to the invention with a predetermined concentric line of weakening.

The present invention relates to an ostomy device comprising a skin plate comprising an adhesive plate for attaching the device to a patient's skin, said plate having an opening for receiving an ostomy and a separate interchangeable collecting bag with a bag flange having an opening for receiving an ostomy wherein the skin plate contains first coupling means firmly connected to the base plate, and the collecting bag contains corresponding second coupling means adapted for releasable coupling and sealing to the skin plate, wherein the bag flange has an inner rim defining the opening therein and a central region having a predetermined weakening line pattern in which the force required for tearing the bag flange from the base plate is less than the force required to break the lines of weakening.

The predetermined weakening line pattern allows the opening of the flange of an ostomy collection bag to be adjusted to the size of the ostomy concerned, leading to better protection of the distal surface of the baseplate adhesive plate, reducing contact with the aggressive exudates and thereby remedying the aforementioned deficiencies. Furthermore, it is simple to adjust the flange opening 10 by gradually increasing it to fit the size of the ostomy by tearing off a portion of the flange along the inner rim using the fingers without the need for tools.

The opening in the flange of the bag according to the invention can thus be adapted to the actual shape of the ostomy. This allows for a combination of the desired cleansing effect compared to the cleansing achieved by the inner edge scraping of the adhesive plate against the outer surface of the stoma when replacing a traditional one-piece stoma device, with the advantage of leaving the two-piece base plate on the stoma of the stoma. longer periods of time.

Furthermore, when the bag is attached to the base plate, the flange protects the distal surface of the base plate 20 and increases its use time and also reduces its soiling.

The pattern of lines of weakness may be any suitable pattern e.g. in the form of punched or cut points, slits or interrupted straight or curved lines weakening the annular flange so as to enable portions thereof 25 to be removed from the inner edge of the flange. The pattern can be made using any suitable method known per se to produce such penetrations in a sheet material. The depth of the notches depends on the nature of the material and can only partially penetrate the thickness of the flange, although it is preferred that it penetrates fully through the flange at the opening edge. It is preferred that the DK 174421 B1 6 line of weakening completely penetrates the thickness of the flange, leaving only smaller bridging areas that can be easily broken to enlarge the opening.

In one embodiment of the invention, the weakening pattern is in the form of a broken line pattern.

In a preferred embodiment of the invention, the weakening pattern in the form of a broken helical line starts at the inner edge of the flange.

In another preferred embodiment of the invention, the weakening line pattern is in the form of a plurality of interrupted concentric lines surrounding the opening of the second flange 10.

In a preferred embodiment of the invention, the weakening line pattern is in the form of a combination of helical or concentric and radial lines, which makes it easy to adjust the size and contour of the aperture to the ostomy.

It is preferred to provide the outer portion of the flange, outside the weakening pattern 15, with perforations in a substantially circular region similar to the kind described in WO 00/30576 for further reducing the risk of leakage due to duct formation.

According to another embodiment of the invention, the central region of the flange with a region of a predetermined weakening line pattern may exhibit only a slight tackiness. Thus, it is preferred that the tack of the central region is so weak that the force to remove the flange from the base plate is less than the force required to break the weakening lines. This allows a good contact to the back of the base plate, which is desirable to protect the same from contamination, and also ensures that the bag can be replaced without breaking the remaining lines of weakening, which can result in the release of waste materials located on the flange. inside the bag. In one embodiment of the invention, it is ensured that the central region exhibits very low tackiness using a flange with a tack having very low tack / peel values, and it is also considered an embodiment of the invention to provide a flange which does not has adhesives in the 7 DK 174421 B1 central area. For practical reasons, it is often less complicated to apply only one layer of adhesive to the entire surface of the flange, and then partially or completely to remove the adhesive properties in the central region by applying any perforated, non-removable cover covering the central area, or 5 e.g. by partially or completely covering the adhesive layer of the central region with a release agent such as talc. The incisions, points, slots or broken straight or curved lines preferably penetrate a cover layer.

In a particularly preferred embodiment of the invention, the weakening pattern of the flange is in the form of concentric lines, wherein the weakening pattern has at least one interrupt in a radial zone from the opening to receive the ostomy. Along this zone, the tear strength is higher than the force required to break the bridges connecting successive rings in the flange. This feature allows the safe removal of an ostomy collection bag along with the entire adhesive flange without leaving one or more rings on the skin plate. The radial direction of such relative reinforcements is preferably in the direction of a protruding portion or ear facilitating removal of the bag. In this embodiment, it is not necessary to rely on a weaker adhesive in the weakening line area to ensure complete removal of the bag and its flange, as discussed above.

In another aspect, the invention relates to an ostomy collection bag having a bag flange 20 having an ostomy receptacle which contains releasable coupling means and sealing to corresponding coupling means firmly connected to a base plate containing an adhesive plate for attaching the base plate to a patient. skin, which plate has an opening for receiving a stoma, wherein the bag flange has an inner rim defining the opening therein and wherein the bag flange has a central region with a predetermined weakening line pattern, wherein the force required to remove the bag flange from the base plate is less than the force needed to break the lines of weakness.

The coupling means may be any coupling means known per se for coupling ostomy base plates to ostomy collection bags, e.g. a mechanical coupling such as corresponding coupling rings, or it may be in the form of a first flange attached to the base plate and a second flange attached to the collecting bag, which second flange is suitable for releasably adhesive coupling and sealing to the first flange. Such a second flange is conveniently the aforementioned bag flange, which then preferably has outer regions of different adhesive capacity for coupling to the base plate beyond the central region.

Preferably, the first and second flanges are formed as slices of cellular plastic material, which provides a good shock absorbing and resilient effect and also has the effect that the weight of the collection system can be held down.

In a third aspect, the invention relates to a flange for an ostomy collection bag having a flange having an opening for receiving a stoma, wherein the flange has an inner rim defining the inlet opening therein and wherein the flange has a central region with a predetermined weakening line pattern, wherein the force required to remove the bag flange from the base plate is less than the force required to break the weakening lines.

Reference is made to Figure 1 of the drawings which shows an embodiment of an ostomy device according to the invention. The bag 1 contains a flange 2 attached to the collection bag, which flange has an inner rim defining an inlet opening 3 therein for receiving an ostomy, and wherein the flange has a central region 4 with a predetermined weakening line pattern 5 in the form of a helical line. starting from its inner rim. The collecting bag 1 for collecting materials coming out of the ostomy is adapted for coupling to a skin plate for attaching the bag 1 around the ostomy to a patient's abdominal wall. The bag 1 can either be closed as shown or open at the bottom for intermittent discharge of its contents. The central region 2 of the flange in this embodiment is surrounded by a substantially annular portion of the flange which acts as coupling means for sealing connection of the bag 1 with a skin plate (not shown). Such a skin plate contains a base plate which is intended to adhere to the patient's skin by means of a skin-friendly adhesive applied to the back of the base plate.

The base plate carries first coupling means which, in this embodiment, are in the form of a first flange or a base plate flange, in which is formed an opening and which is intended to receive an adhesive coupling to the flange 2.

9 DK 174421 B1

The base plate flange can be attached to the base plate with a layer of adhesive applied in a substantially annular junction area with an inner diameter corresponding to the opening in the base plate flange and with an outer diameter such that an edge portion of the flange protrudes on the other side of the adhesive layer. Of course, the flange 5 can also be attached to the base plate by other means, for example by welding.

For example, the bag flange and base plate flange may be formed in a water-repellent cellular plastic material, such as ethylene-vinyl acetate (EVA) or closed cell polyurethane (PUR), so that the cellular plastic material does not absorb liquids.

The bag itself may be made of any material known per se to produce ostomy devices.

On the side facing away from the bag, the flange is substantially covered over the entire surface with a thin, washable adhesive layer (not shown) which may be, for example, a hydrogel adhesive, an acrylate adhesive or a hot melt adhesive.

The adhesive layer is applied in a thin layer, partly to keep the thickness down and partly to maintain the flexibility and elasticity of the bag flange.

This application can, for example, be carried out by coating, spraying or applying in a suitable pattern. In the delivery mode of the bag, the adhesive layer is covered with a release liner.

The bag flange 2 preferably has a protruding portion or ear 8 which facilitates removal of the bag by providing a handle or handle for handling the bag. In such an area, the adhesive is preferably covered by a cover layer.

Figure 2 shows a cross section of the embodiment of a bag according to the invention shown in Figure 1 along line A-A before the bag is prepared for use and showing the incisions 5.

Figure 3 shows the same side view. In Figure 4, the bag is being prepared for application, and a portion 9 of a strip defined by a helical weakening line has been removed from the flange plane and is ready for tearing off, leaving a bag with a better fit to the ostomy than conventional standardized bags.

Figure 5 shows an embodiment of a flange according to the invention with a weakening line pattern 6 in the form of a number of broken concentric lines surrounding the opening 3 of the flange.

Figure 6 shows yet another embodiment of a flange according to the invention with a weakening line pattern 7 in the form of a combination of helical or concentric lines and radial lines surrounding the opening 3 of the flange.

Figure 7 shows another embodiment of an ostomy device according to the invention. In this embodiment, the bag 1 comprises a flange 2 attached to the collection bag, which flange has an inner rim defining an inlet opening 3 therein for receiving a stoma, and wherein the flange has a central region 4 with a predetermined weakening line pattern 5 in form of a helical line extending from its inner rim. In this embodiment, the flange is surrounded by coupling means 15 9 in the form of a coupling ring for sealing connection of the bag 1 with a skin plate.

Figure 8 shows a cross section of the embodiment of Figure 6 along the line B-B showing the coupling ring 9 attached to the bag outside the central region.

Figure 9 shows a preferred embodiment of a flange according to the invention. The central region of the flange 2 has a weakening line pattern 6 in the form of a number of interrupted concentric lines surrounding the opening 3 and is surrounded by a substantially annular portion 10 of the flange which acts as a coupling means for sealing connection of the bag to a skin plate. The weakening pattern has at least one interrupt 11 in a radial zone from the opening for receiving the ostomy 25 toward an ear 8 to facilitate removal of the bag. Such relative reinforcement may be in the form of an interruption of the pattern of the weakening line, shown as two sets of "reinforcement lines" 11. Outside of the annular portion 10, preferably an outer portion 12 is delimited from the annular portion 10 of perforations 13 of the kind. there is 11 DK 174421 B1 described in WO 00/30576, in a substantially circular zone to further reduce the risk of leakage.

Claims (10)

An ostomy device comprising a skin plate comprising an adhesive plate for attaching the device to a patient's skin, said plate having an opening for receiving an ostomy and a separate interchangeable uptake bag with a 5 bag flange having an opening for receiving an ostomy, wherein the skin plate contains first coupling means which are firmly connected to the base plate and the collecting bag contains corresponding second coupling means adapted for releasable coupling and sealing to the skin plate, and wherein the bag flange has an inner rim defining the aperture therein and a central region, which region has a predetermined weakening line pattern. , wherein the force required to remove the bag flange from the base plate is less than the force required to break the lines of weakness. An ostomy appliance according to claim 1, wherein the weakening pattern is in the form of an interrupted line pattern. An ostomy appliance according to claim 1 or 2, wherein the weakening pattern is in the form of 15 punched or cut points, slits or interrupted straight or curved lines. An ostomy appliance according to claim 3, wherein the weakening pattern is in the form of interrupted helical lines extending from the inner edge of the flange. An ostomy appliance according to claim 3, wherein the weakening pattern is in the form of a plurality of 20 interrupted substantially concentric lines surrounding the opening in the second flange. An ostomy appliance according to claim 3, wherein the weakening pattern is in the form of a combination of helical or concentric lines and radial lines. The ostomy appliance according to claim 3, wherein the weakening pattern is in the form of concentric lines and wherein the weakening pattern has at least one interruption in a radial zone from the opening for receiving the ostomy. DK 174421 B1 An ostomy collection bag having a bag flange with an opening for receiving an ostomy comprising bag releasable coupling means and sealing for corresponding coupling means firmly connected to a base plate containing an adhesive plate for attaching the base plate to a patient's skin, said plate having an opening for receiving a stoma, wherein the bag flange has an inner rim defining the aperture therein and wherein the flange has a central region with a predetermined weakening line pattern in which the force required to remove the bag flange from the base plate is less than the force necessary to break the weakening lines. The ostomy collection bag of claim 8, wherein the central region has a predetermined weakening line pattern, does not exhibit cling properties. 10. Flange for an ostomy collection bag having an opening for receiving an ostomy wherein the flange has an inner rim defining the opening therein and wherein the flange has a central region with a predetermined weakening line pattern, wherein the force required to remove the bag flange from the base plate is less. than the force needed to break the lines of weakness.