OSTOMY ATTACHMENT

Abstract

An ostomy attachment comprises a flexible annular seal configured to embrace a stoma and a spout that in use is disposed beneath the stoma and configured to collect ostomy output at skin level and direct ostomy output away from the patient and annular seal and into an ostomy bag, in which the flexible annular seal is formed from an absorbent material and the spout is formed from a non-absorbent material. The annular seal may be an open ring comprising at least one mouldable arm that in use can be wrapped at least partially around the patients' stoma.

Claims

1. A spout for an ostomy attachment that in use is disposed beneath a stoma and configured to collect ostomy output at skin level and direct ostomy output away from the patient and into an ostomy bag, in which the spout is formed from a non-absorbent material.

2. The spout as claimed in claim 1, wherein the spout is an open spout.

3. The spout as claimed in claim 1 in which the spout comprises a partially annular inner rim portion configured to engage with a rim portion of a flexible annular seal, in which the partially annular inner rim portion of the spout is flexible to allow it to conform to a non-uniform stoma.

4. The spout as claimed in claim 1, in which the partially annular inner rim of the spout is thin and optionally angled to optimise collection of ostomy output and delivery of ostomy output directly into the ostomy bag.

5. The spout as claimed in claim 3 in which the annular seal is an open ring comprising at least one mouldable arm that in use can be wrapped at least partially around the stoma.

6. The spout as claimed in claim 3 in which the annular seal comprises two mouldable arms configured for in-situ adjustment to fully embrace the stoma.

7. The spout as claimed in claim 3 in which the annular seal comprises a closed ring which is resiliently deformable.

8. The spout as claimed in any preceding claim 3 in which the annular seal is formed from an absorbent material.

9. The spout as claimed in claim 8 in which the absorbent material is a hydrocolloid material.

10. The spout as claimed in claim 3 in which the spout covers an external surface of a lower part of the annular seal.

11. The spout as claimed in claim 1 in which an underside of the spout comprises a partially annular slot configured for engagement with a mouth of an ostomy bag.

12. The spout as claimed in claim 3 in which the annular seal is flexible to allow it to conform to a non-uniform stoma.

13. The spout as claimed in claim 3, in which the spout is detachably attachable to the annular seal.

14. A method for attaching an ostomy bag to a patient with a stoma, which method employs an ostomy bag having an aperture for receipt of ostomy output, an annular seal, and a spout according to claim 1, the method comprising placing the annular seal on the patient such that the annular seal at least partially surrounds the patients' stoma and attaching the spout to the annular seal to provide an ostomy attachment, wherein the spout on the ostomy attachment is disposed below the patients' stoma, and attaching the ostomy bag to the ostomy attachment.

15. The method as claimed in claim 14 in which the annular seal of the ostomy attachment is an open ring in which the open ring comprises at least one mouldable arm that in use can be wrapped at least partially around the patients' stoma, the method comprising the additional step of moulding the at least one mouldable arm around at least part of the patients' stoma.

16. The method as claimed in claim 14 in which the annular seal comprises two mouldable arms configured for in-situ adjustment to fully embrace the patients' stoma, the method comprising the additional step of moulding the two mouldable arms around the patients' stoma.

17. The method as claimed in claim 14 in which an underside of the spout comprises a partially annular slot configured for engagement with the ostomy bag, in which the step of attaching the bag to the ostomy attachment includes a step of engaging part of the bag with the slot on the underside of the spout.

18. A method of attaching an ostomy bag to a patient with a stoma, which method employs an ostomy bag having an aperture for receipt of ostomy output, an annular seal, and a spout according to claim 1, the method comprising attaching the spout to the annular seal to provide an ostomy attachment, placing the ostomy attachment on the patient such that the annular seal at least partially surrounds the patients' stoma and the spout is disposed below the stoma, and attaching the ostomy bag to the ostomy attachment.

19. The method as claimed in claim 18 in which the annular seal of the ostomy attachment is an open ring in which the open ring comprises at least one mouldable arm that in use can be wrapped at least partially around the patients' stoma, the method comprising the additional step of moulding the at least one mouldable arm around at least part of the patients' stoma.

20. A method as claimed in claim 18 in which the annular seal comprises two mouldable arms configured for in-situ adjustment to fully embrace the patients' stoma, the method comprising the additional step of moulding the two mouldable arms around the patients' stoma.

21. A method as claimed in claim 18 in which an underside of the spout comprises a partially annular slot configured for engagement with the ostomy bag, in which the step of attaching the bag to the ostomy attachment includes a step of engaging part of the bag with the slot on the underside of the spout.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0051] FIG. 1 is a plan view of an ostomy attachment according to the invention;

[0052] FIG. 2 is a plan view of the ostomy attachment of FIG. 1 attached to a patient and partially embracing a stoma;

[0053] FIG. 3 is a sectional side elevational view of the ostomy attachment attached to a patient of FIG. 2;

[0054] FIG. 4 is a sectional side elevational view of an ostomy attachment without a spout attached to a patient;

[0055] FIG. 5 is a sectional side elevational view of the ostomy attachment of FIG. 4 attached to a patient and an ostomy bag attached to the ostomy attachment, showing where stoma output can come into contact with the patients' skin;

[0056] FIG. 6 is a sectional side elevational view of the ostomy attachment of the invention attached to a patient and an ostomy bag attached to the ostomy attachment showing how output from the stoma is directed away from the patients' skin by the spout;

[0057] FIG. 7 is a top plan view of an ostomy attachment according to an alternative embodiment of the invention;

[0058] FIG. 8 is a side elevational view of the ostomy attachment of FIG. 7;

[0059] FIG. 9 is a top plan view of an ostomy attachment according to an alternative embodiment of the invention;

[0060] FIG. 10 is a side elevational view of the ostomy attachment of FIG. 9;

[0061] FIG. 11 is a perspective view of a reusable outer ring forming a first part of the modular two-part fixing plate of the invention;

[0062] FIGS. 12A is a bottom plan view of the reusable outer ring of FIG. 11 and FIG. 12B is a perspective view from below the outer ring of FIG. 11;

[0063] FIG. 13 is a perspective view the inner ring forming the second part of the modular two-part fixing plate of the invention, showing the external (outward facing) side;

[0064] FIG. 14 is a perspective view of the inner ring of FIG. 13, showing the internal (skin facing) side;

[0065] FIG. 15A is a bottom plan view and 15B is a perspective view from below of the modular two-part fixing plate of the invention showing the inner ring of FIG. 13 concentrically engaged within the outer ring of FIG. 11;

[0066] FIG. 16A is a top plan view and 16B is a perspective view from above of the modular two-part fixing plate of the invention showing the inner ring of FIG. 13 concentrically engaged within the outer ring of FIG. 11;

[0067] FIGS. 17A and 17B are sectional side elevational and perspective views of the modular two-part fixing plate of FIG. 16.

DETAILED DESCRIPTION OF THE INVENTION

[0068] All publications, patents, patent applications and other references mentioned herein are hereby incorporated by reference in their entireties for all purposes as if each individual publication, patent or patent application were specifically and individually indicated to be incorporated by reference and the content thereof recited in full.

[0069] Definitions and General Preferences

[0070] Where used herein and unless specifically indicated otherwise, the following terms are intended to have the following meanings in addition to any broader (or narrower) meanings the terms might enjoy in the art:

[0071] Unless otherwise required by context, the use herein of the singular is to be read to include the plural and vice versa. The term “a” or “an” used in relation to an entity is to be read to refer to one or more of that entity. As such, the terms “a” (or “an”), “one or more,” and “at least one” are used interchangeably herein.

[0072] As used herein, the term “comprise,” or variations thereof such as “comprises” or “comprising,” are to be read to indicate the inclusion of any recited integer (e.g. a feature, element, characteristic, property, method/process step or limitation) or group of integers (e.g. features, element, characteristics, properties, method/process steps or limitations) but not the exclusion of any other integer or group of integers. Thus, as used herein the term “comprising” is inclusive or open-ended and does not exclude additional, unrecited integers or method/process steps.

[0073] As used herein, the term “disease” is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to encompass any disorder, illness, abnormality, pathology, sickness, condition or syndrome in which physiological function is impaired irrespective of the nature of the aetiology (or indeed whether the aetiological basis for the disease is established). It therefore encompasses conditions arising from infection, trauma, injury, surgery, radiological ablation, poisoning or nutritional deficiencies.

[0074] As used herein, the term “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which cures, ameliorates or lessens the symptoms of a disease or removes (or lessens the impact of) its cause(s) (for example, the reduction in accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term “therapy”.

[0075] Additionally, the terms “treatment” or “treating” refers to an intervention (e.g. the administration of an agent to a subject) which prevents or delays the onset or progression of a disease or reduces (or eradicates) its incidence within a treated population. In this case, the term treatment is used synonymously with the term “prophylaxis”.

[0076] As used herein, an effective amount or a therapeutically effective amount of an agent defines an amount that can be administered to a subject without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit/risk ratio, but one that is sufficient to provide the desired effect, e.g. the treatment or prophylaxis manifested by a permanent or temporary improvement in the subject's condition. The amount will vary from subject to subject, depending on the age and general condition of the individual, mode of administration and other factors. Thus, while it is not possible to specify an exact effective amount, those skilled in the art will be able to determine an appropriate “effective” amount in any individual case using routine experimentation and background general knowledge. A therapeutic result in this context includes eradication or lessening of symptoms, reduced pain or discomfort, prolonged survival, improved mobility and other markers of clinical improvement. A therapeutic result need not be a complete cure.

[0077] In the context of treatment and effective amounts as defined above, the term subject (which is to be read to include “individual”, “animal”, “patient” or “mammal” where context permits) defines any subject, particularly a mammalian subject, for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sport animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cattle, cows; primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras; food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; and rodents such as mice, rats, hamsters and guinea pigs. In preferred embodiments, the subject is a human.

[0078] The term “modular” as used herein means that the plate is formed from two parts which can attach together and separate as required. This facilitates the plate being formed with a reusable part (outer ring) formed of a material suitable for attaching to the skin, and a second disposable part (inner ring) formed from a hydrocolloid absorbent material suitable for shaping to conform to the stoma. The inner ring is typically adapted for engagement with an ostomy bag, thus allowing the bag and inner ring to be removed together. The modular nature of the fixing plate allows a user to fix the reusable outer ring securely in position, and leave it in situ while allowing multiple changes of the inner ring and ostomy bag. This facilitates ease of use for the user, provides security insofar as the outer ring once in situ does not have to be removed every time the bag is changed, and avoids mechanical dermatitis problems associated with repeated removal of hydrocolloid fixing plates. In addition, use of silicone (or another hypoallergenic skin-safe adhesive) ensures immediate adhesion to the skin, providing the users with a greater sense of security.

[0079] The “protecting layer” as referenced above is a material that provides for handling of the hypoallergenic skin-safe adhesive, and also provides a landing site for the securing the inner ring. In one embodiment, the protecting later is a fabric or polymer film that ideally the adhesive cures to, for example a polyurethane film or a polyester fabric.

[0080] Exemplification

[0081] The invention will now be described with reference to specific Examples. These are merely exemplary and for illustrative purposes only: they are not intended to be limiting in any way to the scope of the monopoly claimed or to the invention described. These examples constitute the best mode currently contemplated for practicing the invention.

[0082] Referring to the drawings and initially to FIGS. 1 to 4, there is shown an ostomy attachment according to the invention and indicated generally by the reference numerals 1. The attachment 1 comprises an annular seal 4 and a spout 2 formed of a non-absorbent material which is configured to direct ostomy output away from the annular seal and the users' skin. In more detail, the annular seal 4 in the form of an open ring and having a lower part 5 that is attached to the spout 2 and an upper part formed into two mouldable arms 7A, 7B that can be adjusted to embrace the stoma 8. The annular seal comprises an absorbent material for example a hydrocolloid material which abuts the skin and has an outer face which presents a landing site for a stoma bag.

[0083] In more detail, and referring to FIGS. 2 to 4, an inner circumference of the annular seal 4 is shaped to form an angled annular shoulder 10, and the spout 2 comprises a part-annular ring 11 that is angled to engage with the shoulder 10, fixing the spout to the annular seal and providing the spout at skin level to optimise collection of ostomy output. In addition, an underside of the spout 2 comprises a curved slot 12 dimensioned to engage with the bag and guide the bag into engagement with the attachment A is best seen in FIG. 3, when the attachment 1 is in-situ on a patient embracing a stoma 8, the spout projects downwardly and outwardly, away from the stoma, thereby directing ostomy output away from the skin and annular seal and into the bag, and also providing an overhang which prevents ostomy output in the bag splashing back against the stoma.

[0084] As can be seen in FIGS. 4 and 5, an ostomy attachment without a spout (which are described in the literature) will not prevent splash-back, and will not prevent ostomy output coming into contact with the users' skin at the area marked A. However, even if the seal does initially prevent ostomy output coming into contact with the skin, as these known seals are generally formed of an absorbent hydrocolloid material which is designed to absorb ostomy output, the ostomy output causes the material of the attachment to breakdown, which results in ostomy output coming into contact with the skin. The ostomy attachment of the invention overcomes this problem by providing a spout formed of a non-absorbent material, which is configured to receive output directly from the stoma and direct it away from the skin and the annular seal. Thus, the annular seal is protected from ostomy output, allowing the seal to be formed of an absorbent material, and the spout which is formed on a non-absorbent material does not break down in response to contact with ostomy output.

[0085] FIG. 6 illustrates an ostomy attachment of the invention 1 attached to a patient and an ostomy bag 15 attached to the ostomy attachment 1 for collection of output from the ostomy bag. The bag 15 has an opening for receipt of ostomy output and an engagement plate 16 formed of a hydrocolloid material forming a periphery around the opening. The engagement plate is configured for engagement with the upper surface of the annular seal 4 and includes a lower part which is dimensioned to engage with the curved slot 12 on the underside of the spout, which helps guide the ostomy bag into engagement with the ostomy attachment.

[0086] In use, the attachment 1 is placed against a users' skin partially embracing the users' stoma and with the lower part of the skin abutting plate placed flush against the lower part of the stoma such that the spout is disposed beneath the stoma. The two mouldable arms 7A and 7B are then adjusted such that they conform to the periphery of the stoma, forming a good seal between the ostomy attachment and the stoma. The bag 15 is then attached to the attachment 1 with the lower part of the engagement plate 16 slotting into the curved slot 12.The hydrocolloid material of surface 4 fuses with the hydrocolloid material of the engagement plate, creating a secure attachment.

[0087] In the above embodiment, a skin abutting plate having two mouldable arms is described, however it will be appreciated that the plate may instead have one single arm which can be moulded around the upper periphery or the entirety of the stoma. Alternatively, the skin abutting plate may be a closed ring which is dimensioned to fit the users' stoma, or which is adjustable (for example resiliently deformable) to conform to different sized and shaped stomas. In addition, the spout as described above is formed from a non-absorbent, rubber-like material, however it may be formed from other materials, for example other forms of non-absorbent polymer, the details of which will be known to a person skilled in the art.

[0088] Examples of absorbent materials for use with the present invention include hydrocolloids, hydrogels and other absorbent materials that may have applications in the wound care and ostomy industry. Examples of non-absorbent materials that may be used with the present invention include polyurethanes, silicones and thermoplastic elastomers.

[0089] Referring to FIGS. 7 and 8, a further embodiment of an ostomy attachment according to invention is illustrated in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the spout 2 is shorter and has a lower profile than the spout illustrated in the previous embodiment (as illustrated in FIG. 8). In addition, the spout is more flexible that the previous embodiment, and is easily deformable in a direction towards the users' skin. The use of this embodiment is substantially the same as that illustrated with reference to the previous embodiment.

[0090] The ostomy attachments described above solve some of the problems of the prior art devices by providing a non-absorbent spout having an inlet at skin level (by virtue of the angled rim), that collects ostomy output at skin level and diverts it away from the users' skin and the annular seal. When the annual seal is an absorbent layer, such as a hydrocolloid, this prevents ostomy output coming into contact with the absorbent material and causing it to break down. In addition, the spout helps direct the ostomy output away from the skin and seal and into the bag, and the underside of the spout helps prevent ostomy output in the bag splashing back on the stoma and/or seal.

[0091] Referring to FIGS. 9 and 10, a further embodiment of an ostomy attachment according to invention is illustrated in which parts identified with reference to the previous embodiment are assigned the same reference numerals. In this embodiment, the spout consists of the partially annular rim portion 11 that engages with an internal rim of the seal (as described with reference to the previous embodiment). The use of this embodiment is substantially the same as that illustrated with reference to the previous embodiment.

[0092] The ostomy attachment of this embodiment helps with convex bag users where the limitations on size expansion of the bag aperature prevents the use of a large protruding spout.

[0093] Referring now to FIGS. 11 to 17, a modular two-part fixing plate for an ostomy bag will be described. The fixing plate, which is indicated generally by the reference numeral 20, comprises two parts, namely an outer ring 21 which is reusable (i.e. can be used multiple times and does not have to be replaced when an ostomy bag is replaced) and an inner ring 22 which is non-reusable (i.e. it is generally discarded when an ostomy bag is discarded).

[0094] Referring specifically to FIGS. 11 and 12, the outer ring 21 has a skin abutting face 23 comprising silicone material for adhering safely to a users' skin, a protecting layer of polymer film 24 to which the silicone is cured for protecting the silicone material and for ease of handling, and an inner periphery comprising a stepped shoulder 25 for engagement with the inner ring 22. The inner circumference of the outer ring 21 comprises a hard plastic or silicone ring 27 which provides structure. Two tabs 28 are provided on the periphery of the outer ring to facilitate removal of the ring from the users' skin as well as facilitating positioning the ring on the users' skin.

[0095] Referring specifically to FIGS. 13 to 14, the inner ring 22 comprises a central annulus 30 formed of a mouldable hydrocolloid material having a central aperture 31 for receipt of a stoma, and a peripheral annular housing 32 which sits on top of the central annulus and has a circumferential periphery that extends beyond circumferential periphery of the central annulus, forming a shoulder 33 that is dimensioned for removable engagement with the stepped shoulder 25 of the outer ring 21. As illustrated in FIG. 14, when the inner and outer rings engage, the bottom face of the hydrocolloid annulus 30 is substantially flush with the silicone skin-abutting face 23 of the outer ring 21. The annular housing is formed of polyurethane material, and includes a single peripheral tab 34 to facilitate separation of the inner ring 22 and outer ring 21.

[0096] FIGS. 15 to 17 show the modular two-part fixing plate 1 in an assembled form, with the inner ring 22 engaged with the outer ring 21.

Equivalents

[0097] The foregoing description details presently preferred embodiments of the present invention. Numerous modifications and variations in practice thereof are expected to occur to those skilled in the art upon consideration of these descriptions. Those modifications and variations are intended to be encompassed within the claims appended hereto.