Absorbent insert for an ostomy appliance

Abstract

An absorbent insert for an ostomy appliance, the ostomy appliance comprising a wafer and a collection pouch, the insert comprising a single, cohesive absorbent body configured for placement within the collection pouch, the absorbent body being non-particulating in use, introducible in a compressed state, and swellable to an expanded state upon wetting, and an elongate tether attached to the absorbent body, wherein, in use, the absorbent body is operative to absorb and immobilize liquid within the lower region of the collection pouch, thereby forming a liquid-laden mass that is anchored by the tether to inhibit upward migration of effluent toward the wafer.

Description

ABSORBENT INSERT FOR AN OSTOMY APPLIANCEField

[0001] The present invention relates to ostomy care accessories, and more particularly to an absorbent insert for use within an ostomy appliance to manage liquid stomal effluent.Background

[0002] An ostomy appliance is a medical device used to collect waste from a surgically created stoma. A typical ostomy appliance comprises a body-side wafer, also known as a baseplate, that adheres to the peristomal skin of a user, and a collection pouch attached to the wafer for receiving stomal effluent. A significant challenge for users of ostomy appliances is the risk of leakage of stomal effluent, particularly when the effluent is of a low viscosity. Such liquid effluent can pool in a lower region of the collection pouch and, during the user's normal daily movements, migrate upwards toward the wafer, where it can compromise the adhesive seal and cause leakage.

[0003] Existing solutions for managing liquid effluent, such as stool solidifiers in the form of gelling agents or absorbent crystals, suffer several problems. These agents can act slowly, allowing leakage to occur before the liquid is absorbed. Furthermore, as such agents swell, they can form mobile clumps, leading to uneven absorption and uncontrolled particulate matter within the pouch that can drift away from the intended lower region.

[0004] In view of these problems, there is an unmet need for an improved solution for managing liquid effluent that effectively inhibits the migration of liquid toward the wafer, thereby extending appliance wear time, enhancing user confidence, and improving the overall quality of life for individuals with stomas.Summary

[0005] According to the present invention, there is provided an absorbent insert for an ostomy appliance, the ostomy appliance comprising a wafer and a collection pouch, the insert comprising: a single, cohesive absorbent body configured for placement within the collection pouch, the absorbent body being non-particulating in use, introducible in a compressed state, and swellable to an expanded state upon wetting; andan elongate tether attached to the absorbent body; wherein, in use, the absorbent body is operative to absorb and immobilize liquid within the lower region of the collection pouch, thereby forming a liquid-laden mass that is anchored by the tether to inhibit upward migration of effluent toward the wafer.

[0006] The tether may be adapted to locate the absorbent body in the lower region of the collection pouch and facilitate retrieval.

[0007] The tether may pass through an aperture in the absorbent body.

[0008] The absorbent body may comprise a biocompatible, non-linting, hydrophilic sponge.

[0009] The absorbent body may comprise polyvinyl alcohol (PVA).

[0010] The insert may be configured for single use and may be non-sterile.

[0011] The absorbent body may be configured to wick liquid away from an outer surface thereof, thereby minimising liquid transfer upon incidental contact prior to saturation.

[0012] The absorbent body may remain soft and flexible in the expanded state.

[0013] The absorbent body, in its compressed state, may be sized and dimensioned for insertion through a top opening or a bottom outlet of the collection pouch.

[0014] The absorbent body may further comprise an odour-reducing agent, for example, charcoal.

[0015] The present invention also provides a stoma care system comprising: an ostomy appliance comprising a collection pouch for receiving stomal effluent; and an absorbent insert as described above insertable within the collection pouch.Brief Description of Drawings

[0016] Non-limiting and non-exhaustive examples are described with reference to the following figures:Figure 1 is schematic front view of an absorbent insert for an ostomy appliance according to an example of the present invention;Figure 2 is a top perspective view of the absorbent insert;Figure 3 is a plan view of the absorbent insert;Figures 4 and 5 are side views of the absorbent insert in a compressed state and an expanded state, respectively;Figure 6 is a schematic view illustrating the insertion of an absorbent insert into a top opening of a collection pouch; andFigure 7 is a schematic view illustrating the insertion of an absorbent insert through a bottom outlet of a drainable collection pouch.Description

[0017] For the purposes of this specification, the following definitions shall apply:• "ostomy appliance" refers to a medical device for collecting waste from a stoma, typically comprising a body-side wafer and a collection pouch.• "wafer" refers to the adhesive component of an ostomy appliance, also known as a baseplate, that adheres to the peristomal skin around the stoma.• "pouch" refers to the collection bag component of an ostomy appliance that is attached to the wafer and serves as a reservoir for stomal effluent.• "stoma" refers to a surgically created opening in the abdomen to allow waste to exit the body.

[0018] The foregoing definitions are provided to clarify the meaning of certain terms used in this specification. They are not intended to be exhaustive or to limit the scope of the invention. The terms are to be given their broadest reasonable interpretation consistent with their commonly understood meaning within the context of the specification as a whole. Unless explicitly stated otherwise, the use of a defined term is not intended to disclaim or surrender subject matter that would otherwise fall within the scope of the claims. Any examples provided within the definitions are for illustrative purposes only and are not intended to be limiting.

[0019] Referring to the drawings, an absorbent insert 10 for an ostomy appliance 12, which comprises a wafer 14 and a collection pouch 16, according to an example of the present invention may generally comprise an absorbent body 18 and an elongate tether 20 attached to the absorbent body 18. In some implementations, the absorbent insert 10 may comprise a single, cohesive absorbent body 18 configured for placement within the collection pouch 16. The absorbent body 18 may be configured to be non-particulating in use, introducible in a compressed state, and swellable to an expanded state upon wetting. In use, the absorbentbody 18 may be operative to absorb and immobilize liquid within the lower region of the collection pouch 16, thereby forming a liquid-laden mass that is anchored by the tether 20 to inhibit upward migration of effluent toward the wafer 14. The tether 20 may be adapted to locate the absorbent body 18 in the lower region of the collection pouch 16 and facilitate hygienic retrieval.

[0020] In some implementations, the tether 20 may pass through an aperture 22 in the absorbent body 18. The absorbent body 18 may comprise a biocompatible, non-linting, hydrophilic sponge. In some implementations, the absorbent body 18 may comprise PVA. In some implementations, the insert 10 may be configured for single use and may be non-sterile.

[0021] In use, the absorbent body 18 may be configured to wick liquid away from an outer surface thereof, thereby minimising liquid transfer upon incidental contact prior to saturation. The absorbent body 18 may also remain soft and flexible in the expanded state. As best seen in Figures 6 and 7, the absorbent body 18, in its compressed state, may be sized and dimensioned for insertion through a top opening 24 or a bottom outlet 26 of the collection pouch 16. In some implementations, the absorbent body 18 may further comprise an odourreducing agent, for example, charcoal. In some implementations, the absorbent insert 10 may be provided in a kit or parts for an ostomy appliance 12 or as part of a stoma care system that comprises an ostomy appliance 12 having a collection pouch 16 for receiving stomal effluent, and an absorbent insert 10 which is insertable within the collection pouch 16.

[0022] In some implementations, the insert 10 may comprise a single-use disposable item intended for placement in a lower interior region of an ostomy pouch 16. Referring to Figures 2 to 5, the absorbent body 18 may be swellable upon contact with liquid and may have a generally rectangular planform with tapered corners. In other implementations, different shapes and geometries may be used for the absorbent body 18, such as cylindrical shapes or circular geometries, to suit different pouch 16 configurations.

[0023] In some implementations, the tether 20 may be attached to the body 18, for example by passing through an aperture 22, and serves to locate the body 18 in the lower region of the pouch 16 and provide a handle for retrieval. The tether 20 may be attached to the body 18 and dimensioned so that, in use, it can be routed to the outlet 24 and folded or seated at a bottom closure 26, thereby anchoring the body 18 near the pouch 16 bottom and providing a clean retrieval handle. In other implementations, other body 18 to tether 20 connections that deliver the same locating and retrieval functions may be used (for example, a bonded eyelet, an embedded loop, or a molded fixture).

[0024] In some implementations, the absorbent body 18 may comprise a hydrophilic, biocompatible sponge that expands upon contact with liquid stool and is non-linting and non- particulating in use. In some implementations, the body 18 may comprise PVA which may be selected for high absorbency and a soft, flexible wet feel. In some implementations, the tether 20 may be a medical-grade member with sufficient tensile strength to withdraw a wetted, loaded body 18 without tearing. Materials may be selected to avoid interference with common pouch vents or filters.

[0025] The absorbent body 18 may be sized and dimensioned to fit within a lower region of a standard ostomy pouch 16. In its compressed state, its profile may be sufficiently small and rigid to allow for easy insertion through a pouch outlet or top opening. In its expanded state, it may be sized and dimensioned to occupy a substantial portion of the lower region of the pouch 16 to act as an effective baffle, without occluding the pouch outlet or pressing unduly against the stoma.

[0026] The function of retaining liquid in a 'lower region' of the pouch 16 may be achieved through a dual mechanism. Firstly, the absorbent body 18 may rapidly absorb and immobilize liquid within its own structure. Secondly, the tether 20 may anchor the now heavier, liquidladen body 18 at the bottom of the pouch 16 or position it in another location inside the pouch 16 spaced apart and away from the wafer 14. This prevents the entire mass from shifting upwards during user movement. By swelling in this anchored position, the body 18 also acts as a physical baffle, restricting the movement of unabsorbed liquid. This combined action of absorption and anchored obstruction is what inhibits effluent from reaching the sensitive wafer area.

[0027] The insert 10 may be configured for versatile application with different types of ostomy appliances 12. Referring to Figure 6, for a closed pouch 16 or for initial placement in any appliance 12, the absorbent insert 10 may be inserted through a top opening 22 of the pouch 16 before the appliance 12 is applied to the user.

[0028] Referring to Figure 7, for a drainable pouch 16, the absorbent insert 10 may be inserted through the bottom outlet 24. This method is particularly convenient for replacing the insert 10 each time the user empties the pouch 16. During this process, the tether 20 may be folded and secured within the pouch's 16 bottom closure 24 mechanism.

[0029] Regardless of the insertion method, the intended final position of the absorbent insert10 is within the lower region of the pouch 16. In this position, the absorbent body 18 may besituated to immediately absorb liquid effluent as it enters the pouch 16 and collects in a lower region of the pouch 16.

[0030] In some implementations, the absorbent body 18 may be formed from a hydrophilic, biocompatible sponge material, such as PVA. A desired feature of the material is that it is non-linting and non-particulating in use. This ensures that no loose fibres or particles are shed, which could otherwise irritate the sensitive stoma tissue or clog the appliance's 12 vents or filters. This structural integrity provides a distinct advantage over prior art absorbent crystals or gelling agents, which can form mobile clumps. The non-particulating absorbent body 18 remains a cohesive unit as it swells, ensuring it stays in its intended location and provides consistent, immediate liquid management.

[0031] While PVA is a suitable material, other materials possessing the required characteristics may also be used in other non-limiting variants. Such materials may, for example, include natural polymers like cellulose or alginates. For example, a regenerated cellulose or calcium alginate sponge can provide high absorbency, biocompatibility, and the ability to be compressed and subsequently swell into a soft, cohesive structure. Alternatively, synthetic polymers such as hydrophilic polyurethane foams, which are used in medical dressings, may be used for their high absorbency and structural integrity when wet. It is also contemplated that superabsorbent polymers (SAPs) could be embedded within a separate structural matrix, such as a polyurethane foam, to increase absorbency while maintaining the single, cohesive nature of the insert 10.

[0032] In use, the body 18 is provided in a compressed state for easy insertion. Upon wetting, the body 18 swells to an expanded state. The material of the absorbent body 18 may exhibit high capillary action, rapidly drawing liquid effluent away from its external surface and into its internal porous structure. This wicking action may ensure that, prior to the body 18 reaching its full absorbent capacity, its outer surface remains substantially free of unbound liquid. In some implementations, the insert 10 may be configured to remain essentially dry until fully saturated, further preventing excess moisture from compromising the adhesive of the baseplate 14. As a result, incidental contact between the insert 10 and the inner wall of the pouch 16 or the wafer 14 region does not readily transfer moisture, which is critical in preserving the adhesive seal of the wafer 14. The material may also be selected such that the sponge 18 remains soft and flexible in its expanded state, avoiding any potential damage to the stoma.

[0033] In some implementations, the insert 10 may comprise additional features. For example, the absorbent body 18 may be enhanced with odour-reducing or odour-masking properties. In other implementations, the insert 10 may be configured as an integrated sponge liner on the internal walls of the stoma bag 16 or be made from biodegradable materials for environmentally conscious users. In some implementations, the insert 10 may may be integrated with, and operatively connected to, digital monitoring systems to track output volume.

[0034] The following examples are intended to illustrate the invention. They are not intended to limit the scope of the invention.ExamplesAdult example

[0035] In a non-limiting example for use in standard adult-sized drainable pouches 16, the absorbent body 18 is provided in a compressed state having a length of 105 mm, a width of 45 mm, and a height (thickness) of 2 mm. In an alternative implementation, the compressed envelope of the body for adult use may be about 85 mm x 65 mm x 6 mm. Upon wetting, the body 18 swells to an expanded state, with growth occurring predominantly in thickness to approximately 3-4 times its compressed height. An absorption capacity of about 150-200 mL before replacement can be employed to preserve free volume for gas and motion.Neonatal example

[0036] An example of the invention is specifically adapted for use in neonatal care, particularly for premature infants in a Neonatal Critical Care Unit (NCCU) with high-output stomas. This vulnerable population has extremely fragile skin due to an underdeveloped stratum corneum and decreased adhesive structure between the epidermis and dermis, making them highly susceptible to peristomal skin breakdown from pouch leakage. For this example, a smaller neonatal insert, such as one having a compressed state of approximately 60 mm in length, 30 mm in width, and 2 mm in height, is used to fit neonatal pouches 16. In another implementation for neonatal sizing, the compressed envelope may be about 45 mm x 35 mm x 4 mm, expanding to about 10-12 mm in thickness (approximately 2.5-3x) with lateral growth not more than about 8%. A target absorption prior to replacement may be about 25-40 mL. A primary advantage in this context is the insert's ability to manage high effluent output, defined as greater than 20ml / kg / day, which is a common complication. By absorbing and immobilizingthis watery effluent, the insert 10 prevents leakage and significantly improves stoma appliance wear time. This reduces the frequency of full appliance 12 changes, a critical benefit that minimizes trauma to the fragile neonatal skin and reduces the risk of painful skin breakdown and infection. Furthermore, by containing the effluent, the insert enables accurate measurement of stoma output, for example by weighing the removed sponge 18, which is essential for the precise fluid and electrolyte management required by these infants. This simplified and more effective management can also reduce stress for families and caregivers.Flushable and biodegradable example

[0037] In further embodiments, the insert is constructed from flushable and biodegradable materials designed to maintain structural integrity during use while safely dispersing upon disposal in a toilet. This is achieved using a material or binder system that remains stable in the high-solute, low-volume environment of a stoma pouch but rapidly breaks down when exposed to the large volume of water and turbulent shear forces of a toilet flush. For instance, the absorbent body may be formed from an air-laid nonwoven web of biodegradable fibres, such as wood pulp fluff, viscose, or calcium alginate, held together with a water-sensitive or cold-water-soluble PVA binder. Alternatively, the body may be fabricated from a water- dispersible PVOH / PVA foam, with optional cellulosic or alginate reinforcement zones. The tether is similarly made from a compatible, dispersible material, such as a twisted cellulosic yarn or a braided cord of soluble PVA. A representative flushable variant may have a compressed envelope of about 80 mm x 60 mm x 5 mm, swelling to about 15-20 mm, with a target absorption capacity of 120-160 mL111. This construction provides robust in-pouch performance with the convenience of environmentally responsible disposal.

[0038] In these examples, the absorbent body may be produced by foam or sponge fabrication and then compressed to a target insertion profile. An aperture may be formed and a tether threaded or integrated using standard converting operations. Packaging may provide singleunit dispensing and clean handling for the user.

[0039] The insert 10 of these examples is suitable for routine ostomy care across hospital and community settings. It integrates with existing pouch closures and coupling systems, requires no modification to baseplate geometry or adhesive, and can be produced with established sponge-manufacturing and converting processes.

[0040] The invention is not limited to the examples that have just been given. Those skilled in the art will appreciate that the examples may be reproduced without difficulty, and with similarsuccess, by substituting or varying any of the generically or specifically described elements or sequence of method steps, mentioned anywhere in this specification for those actually used in the preceding examples.

[0041] Embodiments of the present invention provide an absorbent insert for an ostomy appliance that is both generally and specifically useful for managing liquid stomal effluent to inhibit the migration of liquid toward the wafer, thereby extending appliance wear time, enhancing user confidence, and improving the overall quality of life for individuals with stomas.

[0042] Embodiments of the invention provide a single-use absorbent insert for an ostomy appliance. The insert is configured for placement within the collection pouch and comprises an absorbent body and an elongate tether. The absorbent body is provided in a compressed state to facilitate easy insertion. Upon contact with liquid effluent, the body expands and absorbs the liquid, retaining it in a lower region of the pouch to inhibit migration toward the wafer. The tether is attached to the absorbent body and is configured to anchor the body in the lower region of the pouch and to facilitate hygienic retrieval. By effectively managing liquid at its source, embodiments of the invention advantageously avoid or reduce the risk of leakage, preserves the integrity of the adhesive seal, and improves the user's comfort and confidence.

[0043] Unless the context requires otherwise, the word "comprising" means "including but not limited to," and the word "comprises" has a corresponding meaning.

[0044] Any reference to prior art is not an admission that the prior art is common general knowledge.

[0045] The invention is not limited to the examples given above. Instead, the scope of the invention supported by the above examples is defined by the claims that follow.

Claims

Claims1. An absorbent insert for an ostomy appliance, the ostomy appliance comprising a wafer and a collection pouch, the insert comprising: a single, cohesive absorbent body configured for placement within the collection pouch, the absorbent body being non-particulating in use, introducible in a compressed state, and swellable to an expanded state upon wetting; and an elongate tether attached to the absorbent body; wherein, in use, the absorbent body is operative to absorb and immobilize liquid within the lower region of the collection pouch, thereby forming a liquid-laden mass that is anchored by the tether to inhibit upward migration of effluent toward the wafer.

2. The insert of claim 1 , wherein the tether is adapted to locate the absorbent body in the lower region of the collection pouch and facilitate retrieval.

3. The insert of claim 1 or 2, wherein the tether passes through an aperture in the absorbent body.

4. The insert of any preceding claim, wherein the absorbent body comprises a biocompatible, non-linting, hydrophilic sponge.

5. The insert of claim 4, wherein the absorbent body comprises polyvinyl alcohol.

6. The insert of any preceding claim, wherein the insert is configured for single use and is non-sterile.

7. The insert of any preceding claim, wherein the absorbent body is configured to wick liquid away from an outer surface thereof, thereby minimizing liquid transfer upon incidental contact prior to saturation.

8. The insert of any preceding claim, wherein the absorbent body remains soft and flexible in the expanded state.

9. The insert of any preceding claim, wherein the absorbent body, in its compressed state, is sized and dimensioned for insertion through a top opening or a bottom outlet of the collection pouch.

10. The insert of any preceding claim, wherein the absorbent body further comprises an odour-reducing agent.11 . The insert of claim 10, wherein the odour-reducing agent is charcoal.

12. A stoma care system comprising: a collection pouch for receiving stomal effluent; and an absorbent insert as claimed in any one of claims 1-11 insertable within the collection pouch.

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