GB2595893A

GB2595893A - An ostomy-changing facilitating device

Info

Publication number: GB2595893A
Application number: GB2008773.0A
Authority: GB
Inventors: Daniel Lloyd-Jones Neil
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-06-10
Filing date: 2020-06-10
Publication date: 2021-12-15
Anticipated expiration: 2040-06-10
Also published as: GB2595893B; GB202008773D0; WO2021250367A1

Abstract

An ostomy changing facilitating device and kit for facilitating cleaning of peristomal skin during changing of an ostomy bag comprises the provision of a device 10 comprising an elastically deformable sheet 12 formable into a tubular configuration that is adaptable to the diameter of a user’s stoma. A first edge 14 of the elastically deformable sheet forms a flanged base in the tubular configuration. The device further comprises at least one resilient member 22 configured to bias the sheet in the tubular configuration. The sheet may comprise a flanged base 20, comprising a plurality of pre-cut tabs 30 with an adhesive. An ostomy bag 110 (Figure 6) having an adjustable diameter inlet orifice, suitable for use with the changing facilitating device, is also disclosed.

Description

I

AN OSTOMY-CHANGING FACILITATING DEVICE

The present invention relates to an ostomy-changing facilitating device, in particular, a device that facilitates cleaning of peristomal skin during the change of an ostomy bag. The present invention further relates to an ostomy collection pouch for an ostomy-changing facilitating device and kit comprising said ostomy collection pouch and said ostomy-changing facilitating device.

INTRODUCTION

A number of diseases of the gastro-intestinal tract require surgical intervention that, in many cases, result in a patient requiring an ostomy, such as a colostomy or an ileostomy. An ostomy creates an artificial opening on the abdomen, which can be connected to the digestive or urinary system via a stoma in the abdominal wall to provide a new pathway for the discharge of effluents or waste products (urine or faeces) out of the body. The contents from a stoma are generally collected in collection bags, which are emptied by the patient at suitable times throughout the day. The bag itself must also be frequently replaced, either on a routine basis or due to failure of the bag. The peristomal skin (i.e. the area of skin surrounding the stoma) should be thoroughly cleaned during each bag change to reduce the risk of infection. However, it is generally not feasible to clean the peristomal skin prior to removing the collection bag as the area is not easily accessible when bag is in place. This is because typical collection bags are configured to be held as close to the skin as possible for patient discretion and comfort.

The replacement of a collection bag therefore typically involves the following steps: removal of the old collection bag; thoroughly cleaning the stoma and the peristomal skin, for example, with water and soaked gauzes; drying the peristomal skin and attaching a new replacement bag. The new bag is secured to the skin via an adhesive wafer, which may be integrally formed with the bag as a one-piece appliance or provided as a separate body-side member in a two-piece appliance. In either case, it is imperative that the peristomal skin and/or the adhesive wafer are completely dry in order to form an effective seal.

However, the discharge of waste products from the stoma cannot be regulated at will. Thus, patients frequently encounter problems when substituting an old collection bag with a new one due to contamination caused by an active bowl. In particular, aggressive secretions from the stoma may contaminate the peristomal skin, resulting in an improper adhesion to the skin and leakage. Thus, the entire process must be repeated until an effective seal is obtained. This is not only time-consuming and inconvenient, but may also be stressful for patients and care providers.

One solution is to provide a sealing device that enables temporary closure of the stoma to facilitate bag substitution. However, known devices of this type have several disadvantages. For example, such devices typically involve forming a temporary closure by inserting the device into the stoma or by covering the stoma to form a seal. Such physical contact with stoma may cause discomfort or pain or risk damaging of the intestinal wall.

The use of existing devices may further be limited due to the variation observed in stoma sizes, which occurs naturally from patient to patient. This is particularly evident between patient groups, such as neo-natal or paediatric patients and adult patients. The size of a stoma may also differ according to the stoma type (e.g. arising due to an ileostomy vs a colostomy). This variation can lead to ill-fitting devices, which may suffer from leaks. In some cases, known devices may be provided in a plurality of sizes to account for variations in stoma sizes. However, this may lead to higher manufacturing costs and also fail to provide an effective solution, as a single device having a fixed set of dimensions may still be required to fit a range of different sized stomas.

An alternative solution is disclosed in GB2491161A in the form of a funnel to direct any discharge away from the skin. This allows a patient to thoroughly clean and dry the peristomal skin before the funnel is removed and a replacement collection bag is put in place. However, a funnel-shaped device may be challenging and costly to manufacture. Further, such a device may be awkward to store and transport, which may further increase production costs and limit portable use. Additionally, the lack of a means to contain discharge beyond the capacity of the tunnel may limit the practical convenience of such a device.

This invention aims to obviate or mitigate the existing disadvantages associated with changing stoma appliances known in the art. In particular, it is an aim of this invention to provide a device that is simple to use and allows a patient to replace a stoma bag in a convenient and effective manner.

SUMMARY OF INVENTION

In a first aspect, there is provided a ostomy-changing facilitating device, comprising: an elastically deformable sheet formable into a tubular configuration adaptable to the diameter of a user's stoma; wherein a first edge of the elastically deformable sheet forms a flanged base in the tubular configuration; and at least one resilient member configured to bias the sheet in the tubular configuration.

The ostomy-changing facilitating device of the present invention is intended for use during the replacement of stoma appliances. Prior to use, a user bends the elastically deformable sheet into the tubular, in-use, configuration for placement over the stoma. The dimensions of a stoma vary for each patient, particularly between neo-natal or paediatric patients and adult patients. The ostomy-changing facilitating device of the present invention is therefore advantageous as it may be adjusted by a user to fit their specific stoma size by adjusting the diameter of the tubular configuration. Thus, a device having a particular set of dimensions may be provided and adjusted to fit a range of different sized stomas. The resilient member provides the advantage that it allows the device to maintain the tubular configuration during use. This helps to ensure that an effective seal is formed around the stoma, irrespective of the stoma size, thereby reducing the risk of leak.

The ostomy-changing facilitating device of the present invention is also simple and easy to use. This is particularly advantageous as the waste product from a stoma is often low viscosity, so it is important to direct it away from the skin as quickly as possible during appliance replacement. Additionally, the thin design of the elastomerically deformable sheet may be easily and efficiently manufactured. Moreover, owing to the thin design, the device may be efficiently packaged and/or stored for transportation and/or portable use. For example, a plurality of sheets may be stacked vertically in convenient pre-packaged packs.

Optionally, at least a portion of the first edge comprises an adhesive for releasably securing the device to the user's skin. In this way, a user may temporarily attach the device to their skin whilst cleaning around the stoma This is particularly advantageous for user's having a limited mobility.

Optionally, the resilient member is arranged adjacent to the first edge of the elastically deformable sheet such that, when the device is in the tubular configuration, the resilient member is configured to generally surround the user's stoma. This helps to further establish an effective seal around the stoma, thereby reducing the risk of leak.

Optionally, the device may comprise a plurality of resilient members. Suitably at least one resilient member is arranged adjacent to the first edge of the elastically deformable sheet such that, when the device is in the tubular configuration, the resilient member is configured to generally surround the user's stoma. One or more further resilient member(s) may be used to enhance stabilisation of the device in the tubular configuration.

Optionally, the elastically deformable sheet comprises a first layer and a second layer. Additionally, the resilient member may be arranged between the first and second layers. This arrangement may be particularly advantageous as it prevents contact occurring between the resilient member and the user's skin. Accordingly, this minimises any risks of the resilient member scratching or irritating the user's skin.

Optionally, the resilient member is a malleable wire.

Optionally, the first edge of the elastically deformable sheet has a length in the range of 200 mm to 300 mm, such as 220 mm to 280 mm, or 240 mm to 260 mm, for example, 250 mm. In this way, the diameter of the tubular configuration may be adjusted to fit a range of stomas sizes having a diameter between 30 to 70 mm. However, as would be understood by a person skilled in the art, the first edge of the elastically deformable sheet may be of any length suitable to fit the desired range of stoma sizes. For example, the first edge of the elastically deformable sheet may have a length of approximately at least 100 mm, at least 150 mm, or at least 180 MM.

Optionally, the ostomy-changing facilitating device is a single-use device. The device being in sheet form prior to use is particular advantageous when intended for single-use allowing the user to easily store and carry a plurality of such devices with them.

Optionally, at least a portion of a longitudinal edge of the elastically deformable sheet comprises an adhesive for securing the sheet in the tubular configuration. This also provides an additional advantage by sealing the joint at the overlapping section of the sheet in the tubular configuration, thereby reducing the risk of leaks.

Optionally, the longitudinal edge of the elastically deformable sheet has a length of at least 100 mm. However, it would be understood by a person skilled in the art that the longitudinal edge of the elastically deformable sheet may be of any length that is suitable to facilitate cleaning of areas not easily accessible when a more permanent ostomy appliance is in place. Additionally, a user may cut the elastically deformable sheet to a desired length prior to use.

Optionally, the first edge comprises a plurality of pre-cut tabs. The pre-cut tabs fold outwards to form the flanged base, which is brought into contact with the user's skin during use. Additionally, one or more of the pre-cut tabs may include an adhesive for releasably securing the device to the user's skin. It will be appreciated by a person skilled in the art that the tabs will be suitably sized to ensure that device stays in place while also allowing effective cleaning. Alternatively, when pre-cut tabs are not present, a user may cut the tabs prior to use.

Optionally, the adhesive used in the present invention is a medical grade adhesive. For example, the adhesive may be medical grade adhesive tape. Additionally, the adhesive may be protected by a releaseable film that is removed prior to use.

Optionally, the elastically deformable sheet is made from laminated plastic or medical grade silicone. However, as would be appreciated by a person skilled in the art, any suitable material may be used so as to provide a sterile device having durable and reliable construction. Suitably, the elastically deformable sheet may be constructed of a material that may be easily cut to size.

In a second aspect, there is provided an ostomy collection pouch for an ostomy-changing facilitating device according to the first aspect, comprising: a bag body having a resealable inlet orifice, wherein the inlet orifice has an adjustable diameter for receiving the ostomy-changing facilitating device in a tubular configuration.

The ostomy collection pouch provides a means for collecting, via an ostomy-changing facilitating device according to the first aspect, waste contents excreted from a stoma during replacement of a more permanent ostomy appliance. This combination may be particularly advantageous when replacing an ostomy appliance outside of a domestic environment. The inlet orifice, by virtue of having an adjustable diameter, is configured to receive ostomy-changing facilitating devices possessing a range of different diameters in the tubular configuration. In this way, the ostomy collection pouch is compatible with the ostomy-changing facilitating device according to the first aspect.

Optionally, the inlet orifice is resealable by a flap. For example, at least a portion of the sealing side of the flap may be provided with an adhesive.

Optionally, the inlet orifice is surrounded by a substantially annular elastomeric peripheral wall. Advantageously, the inlet orifice may securely fit the ostomychanging facilitating device according to the first aspect once in tubular configuration after adapted to the size of the user's stoma. That is, the elastomeric peripheral wall may mechanically deform upon insertion of an ostomy-changing facilitating device into the inlet orifice. Thus, the elastomeric peripheral wall squeezes against the ostomy-changing facilitating device and the resulting force ensures a secure contact between the inner surface of the inlet orifice and the outer surface of the ostomy-changing facilitating device. Suitably, the elastomeric peripheral wall may retract to substantially its original size when the ostomy-changing facilitating device is withdrawn from the inlet orifice.

Optionally, the ostomy collection pouch further comprises an outlet operable by a tap arranged on the lower part of the bag body. In this way, the outlet may be used to empty the bag or collect a sample for analysis.

In a third aspect, there is provide an ostomy-changing facilitating kit comprising an ostomy-changing facilitating device according to the first aspect and an ostomy collection pouch according to the second aspect.

Optionally, the ostomy-changing facilitating device and the ostomy collection pouch are provided as a one-piece component.

Optionally, the ostomy-changing facilitating kit further comprises a sealable bag. For example, the sealable bag may be a clinical waste bag. Additionally or alternative, the sealable bag may serve as a convenient carry bag for holding and transporting the kit components and, after use, provide a means for safely disposing of the used kit. Thus, the sealable bag may serve a dual purpose. As would be appreciated by a person skilled in the art, the sealable bag may be of any size suitable to accommodate the ostomy-changing facilitating device and the ostomy collection pouch.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings illustrate presently exemplary embodiments of the disclosure, and together with the general description given above and the detailed description of the embodiments given below, serve to explain, by way of example,

the principles of the disclosure.

Figure 1 is a perspective view of an ostomy-changing facilitating device according to one embodiment of the invention; Figure 2 is a perspective view of the ostomy-changing facilitating device of Figure 1 in a tubular configuration; Figure 3 is a schematic view showing the longitudinal cross-section of the ostomy-changing facilitating device of Figure 1; Figure 4 is a perspective view of the ostomy-changing facilitating device of Figure 1 in an intermediate configuration and a tubular configuration; Figure 5 is a perspective view of the ostomy-changing facilitating device of Figure 1 in use; Figure 6 is a front view of a ostomy collection pouch according to a second aspect of the invention; Figure 7 is a front view of the ostomy collection pouch of Figure 6 showing the resealable flap peeled back.

DETAILED DESCRIPTION

The present invention provides an ostomy-changing facilitating device. That is, a device that facilitates cleaning of peristomal skin during the change of an ostomy bag or appliance. The present invention further provides an ostomy collection pouch for collecting, via the ostomy-changing facilitating device, waste contents excreted from a stoma. A kit comprising said ostomy collection pouch and said ostomy-changing facilitating device is also provided.

An ostomy-changing facilitating device 10 according to one embodiment is shown in Figure 1. The device 10 comprises an elastomerically deformable sheet 12 that is formable into a generally tubular configuration, as shown in Figure 2. The tubular configuration is essentially cylindrical and has an open first end 14 and an open second end 16, wherein the open first end 14 is configured to be disposed over and about a user's stoma. In particular, a first edge 18 of the elastically deformable sheet 12 forms a flanged base 20 at the first open end 14 of the tubular configuration for contacting the user's skin during use. The device 10 further comprises at least one resilient member 22 configured to bias the sheet in the tubular configuration.

As best seen in Figure 3, the elastically deformable sheet 12 of the illustrated embodiment comprises first and second layers 24, 26. The first and second layers 24, 26 are made of laminated plastic. However, any suitable material may be used.

Additionally, the resilient member 22 is a malleable wire that is arranged between the first and second layers 24, 26. This minimises the risk of contact occurring between the resilient member 22 and a user's skin. This may be particularly advantageous for users with skin allergies. However, other suitable arrangements will be apparent to a person skilled in art.

Prior to use, a user forms the tubular configuration by bending the elastically deformable sheet 12 such that the opposing longitudinal edges meet and overlap, as shown in Figure 4. The diameter of the tubular configuration is adaptable to the diameter of a user's stoma by adjusting the extent to which the opposing longitudinal edges overlap. At least a portion of a longitudinal edge 28 of the elastically deformable sheet may include an adhesive for securing the sheet in the tubular configuration and reducing the risk of leaks. Alternatively or additionally, the overlapping section of the sheet in the tubular configuration may be placed at the top during use to minimise potential leakage through the joint. The device 10 is then temporarily placed around the stoma such that the flanged base 20 is brought into contact with the user's skin, as shown in Figure 5. In the illustrated embodiment, the first edge 14 comprises a plurality of pre-cut tabs 30, which fold outwards to form the flanged base 20. Additionally, the pre-cut tabs 30 include an adhesive 32 for releasably securing the device to the user's skin. The adhesive may be protected by a releaseable film 32 that is removed prior to use. The pre-cut tabs 30 are suitably sized to ensure that device 10 stays in place while also allowing effective cleaning.

Once in place, the ostomy-changing facilitating device 10 directs faecal matter away from the skin to allow at leisure cleaning around areas that are not easily accessible when a typical ostomy appliance e.g., a colostomy bag, is in place. The resilient member 22, for example, the malleable wire, may be arranged adjacent to the first edge 18 such that the resilient member 22 generally surrounds the user's stoma when the device 10 is in place. This helps to ensure that an effective seal is obtained between the device 10 and the user's skin. In this way, the device 10 allows a user to clean and dry the skin with confidence and dignity before applying a more permanent ostomy appliance.

During use, the ostomy-changing facilitating device 10 may be directed over a kidney bowl, or other receptacle, or over an absorbent gauze.

Alternatively, a collection pouch 110 is provided according to the present invention for use with the ostomy-changing facilitating device 10 described above. The collection pouch 110 provides a means for collecting, via the ostomy-changing facilitating device 10, waste contents excreted from a stoma. A collection pouch 110 according to one embodiment is shown in Figures 6 and 7. The collection pouch 110 comprises a bag body 112 having a resealable inlet orifice 114. The inlet orifice 114 has an adjustable diameter for receiving the ostomy-changing facilitating device 10 in a tubular configuration. In the illustrated embodiment, the inlet orifice 114 is surrounded by a substantially annular elastomeric peripheral wall 116. In this way, the elastomeric peripheral 116 wall may expand upon insertion of an ostomychanging facilitating device 10 into the inlet orifice 114. The elastomeric peripheral wall 116 may retract to substantially its original size when the ostomy-changing facilitating device 10 is withdrawn from the inlet orifice. Alternatively, the diameter of the inlet orifice 114 may be manually adjusted by a user, for example, with the use of scissors. The bad body 112 may also include a carrying means, such as a handle 118.

In the illustrated embodiment, the inlet orifice 114 is resealable by a flap 120 having a mild adhesive on the inner side. As shown in Figure 7, the flap 120 is peeled back to expose the inlet orifice 114. Once the bag body 112 is full, the inlet orifice 114 is sealed by rewinding the peeled back flap 120. An outlet operable by a tap 122 is also arranged on the lower part of the bag body 112. The outlet may be used to collect a sample of the contents. Alternatively, the collection pouch 110 may be emptied though the outlet should it fill at speed and the need arises.

The ostomy-changing facilitating device 10 and ostomy collection pouch 110 may be provided separately or in combination as a kit. Additionally, the ostomy-changing facilitating device 10 and the ostomy collection pouch 110 may be provided as a one-piece component.

It will be appreciated by persons skilled in the art that the above embodiment has been described by way of example only and not in any limitative sense, and that various alterations and modifications are possible without departing from the scope of the invention as defined by the appended claims.

Claims

CLAIMS1. An ostomy-changing facilitating device, comprising: an elastically deformable sheet formable into a tubular configuration adaptable to the diameter of a user's stoma; wherein a first edge of the elastically deformable sheet forms a flanged base in the tubular configuration; and at least one resilient member configured to bias the sheet in the tubular configuration.
2. The ostomy-changing facilitating device according to claim 1, wherein at least a portion of the first edge comprises an adhesive for releasably securing the device to the user's skin.
3. The ostomy-changing facilitating device according to claims 1 or 2, wherein the resilient member is arranged adjacent to the first edge of the elastically deformable sheet such that, when the device is in the tubular configuration, the resilient member is configured to generally surround the user's stoma.
4. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the elastically deformable sheet comprises a first layer and a second layer.
5. The ostomy-changing facilitating according to claim 4, wherein the resilient member is arranged between the first and second layers.
6. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the resilient member is a malleable wire.
7. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the first edge of the elastically deformable sheet has a length in the range of approximately 200 mm to 300 mm.
8. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the device is a single-use device.
9. The ostomy-changing facilitating device according to any one of the preceding claims, wherein at least a portion of a longitudinal edge of the elastically deformable sheet comprises an adhesive for securing the sheet in the tubular configuration.
10. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the longitudinal edge of the elastically deformable sheet has a length of at least 100 mm.
11. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the first edge comprises a plurality of pre-cut tabs.
12. The ostomy-changing facilitating device according to any one of claims 1 to 11, wherein the adhesive is a medical grade adhesive.
13. The ostomy-changing facilitating device according to any one of the preceding claims, wherein the elastically deformable sheet is made from laminated plastic or medical grade silicone.
14. An ostomy collection pouch for an ostomy-changing facilitating device according to any one of the preceding claims, comprising: a bag body having a resealable inlet orifice, wherein the inlet orifice has an adjustable diameter for receiving the ostomy-changing facilitating device in a tubular configuration.
15. The ostomy collection pouch according to claim 14, wherein the inlet orifice is resealable by a flap.
16. The ostomy collection pouch according to claims 14 or 15, wherein the inlet orifice is surrounded by a substantially annular elastomeric peripheral wall.
17. The ostomy collection pouch according to any one of claims 14 to 16, further comprising an outlet operable by a tap arranged on the lower part of the bag body.
18. An ostomy-changing facilitating kit comprising an ostomy-changing facilitating device according to any one of claims 1 to 13 and an ostomy collection pouch according to any one of claims 14 to 17.
19. The ostomy-changing facilitating kit according to claim 18, wherein the ostomy-changing facilitating device and the ostomy collection pouch are provided as a one-piece component.
20. The ostomy-changing facilitating kit according to claims 18 or 19, further comprising a clinical waste bag.