Patent ID: 12201548

DETAILED DESCRIPTION OF THE INVENTION

Prior to setting forth the invention, a number of definitions are provided that will assist in the understanding of the invention. All references cited herein are incorporated by reference in their entirety. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Unless otherwise indicated by context, the use herein of the singular is to be read to include the plural and vice versa. As such the terms “a”, “an”, “one or more”, and “at least one” are used interchangeably herein.

As used herein, the term ‘comprising’ means any of the recited elements are necessarily included and other elements may optionally be included as well. ‘Consisting essentially of’ means any recited elements are necessarily included, elements which would materially affect the basic and novel characteristics of the listed elements are excluded, and other elements may optionally be included. ‘Consisting of’ means that all elements other than those listed are excluded. Embodiments defined by each of these terms are within the scope of this invention.

As used herein the term “absorbent” refers to a property of a material in which it can absorb water or other liquids. The term “absorbent material” refers to a material that has absorbent properties. The absorbent material may be materially affected by absorbing the water or other liquids, for example, the material may expand, distort, become unstable, degenerate or decompose. Examples of absorbent materials in the context of the present application are hydrocolloids and hydrogels. In contrast, the term “non-absorbent” refers to a property of a material in that it does not absorb water or other liquids. The term “non-absorbent material” refers to a material that has non-absorbent properties. The non-absorbent material may remain visibly and structurally unchanged after contact with these liquids. Examples of non-absorbent materials in the context of the present application are rubber, rubber-like materials, polyurethanes, silicones and thermoplastic elastomers. Further examples of non-absorbent materials may be thermosetting plastics and metals, such as shape-memory metals or foils.

As used herein the term “hydrocolloid” refers to a material that typically contain polymers such as polyisobutylene, and hydroactive particles such as sodium carboxymethyl cellulose, gelatine and pectin. The hydrocolloid swells on contact with hydrophilic fluids to form a semi-solid gel.

As used herein the term “resiliently deformable” refers to the ability of a material or a structure to bend or flex under a suitable force and when that force is removed to return substantially or exactly to the original shape or position.

As used herein the term “flexible” refers to the ability of a material or a structure to bend or flex under a suitable force.

As used herein the term “ostomy seal” or “seal” refers to a component that forms part of an ostomy attachment and acts to provide a fluid-tight seal between the stoma and the ostomy bag in which stomal output collects. Typically, an ostomy seal is biocompatible and is safe to use in contact with skin. Suitably, the ostomy seal has adhesive properties meaning it may adhere to the skin and/or other parts of the ostomy attachment. Suitably the ostomy seal is formed of an absorbent material such as hydrocolloid or a hydrogel. In embodiments, the ostomy seal is a planar annular ring (complete or broken one or more times by radial cuts) having an inner face and an outer face, wherein the outer face is generally perpendicular to the inner face, An inner wall or inner rim, generally perpendicular to the inner and outer face borders and/or surrounds a central opening in the ostomy seal. Concentrically arranged outside of, and generally parallel to the inner rim, is an outer wall or outer rim. Typically, the distance between the inner and the outer face is less than the distance between the diametrically opposed points on the outer rim.

As used herein the term “bag” refers to any form of receptacle suitable for collecting ostomy output. The term may be used interchangeably with the terms “pouch” and “receptacle”. The bag is typically formed of a front liquid impermeable layer and a back liquid impermeable layer that are joined at their respective outer peripheries. The join may be a seal, partial or complete, around the circumference of the outer peripheries of the front and back liquid impermeable layers. One liquid impermeable layer, typically the back liquid impermeable layer, has an opening or aperture for entrance of the ostomy fluid and/or the stoma. The bag may have one or more additional openings, typically at the bottom when in use, that when required can be opened to empty the bag.

As used herein the term “in” in the context of a bag refers to the interior volume of the bag. The term “inward” or “inwardly” as used herein refers to a direction towards or into the interior volume of the bag. Conversely, As used herein the term “out” in the context of a bag refers to the space outside of the interior volume of the bag. The term “outward” or “outwardly” as used herein refers to a direction towards or out of the interior volume of the bag. The term “radially outward” or “radially outwardly” refers to a direction on a away from a defined object or centre thereof (or an approximation thereto).

As used herein, the term “front” refers to the side furthest from and/or facing away from the skin of the user as it would be in use. The term “rear” or “back” refers to the side closest to and/or facing the skin of the user as it would be in use. The term “bottom” or “inferior” refers to the lower end, or the lower end, optionally nearer the user's feet when in normal use. The term “top” refers to the upper end, or the higher end, optionally nearer the user's head when in normal use.

The present invention provides an improved ostomy bag that comprises a spout that projects into the interior volume of the bag and is able to direct the output from the stoma, typically under gravity, away from the skin to be collected into the ostomy bag. The ostomy bag of the present invention also provides for an ostomy bag that reduces or prevents stomal fluid splashing back onto an ostomy seal or skin, thereby providing an ostomy bag arrangement that has improved longevity in use and causes less skin irritation.

The ostomy bag of the present invention also acts to prevent blocking of the stoma by the front side of the bag reducing the propensity for leaks and so-called “pancaking” or “pattycaking”. The present invention also provides for an improved ostomy bag that is easier for the patient to use and position.

FIG.1of the drawings shows an ostomy bag1according to one embodiment of the invention.FIG.2, shows the ostomy bag1ofFIG.1with a cover on each side shown in exploded view.

In embodiments, the ostomy bag1comprises a front liquid impermeable layer2and a rear liquid impermeable layer4. The front and rear liquid impermeable layers2,4are configured to be joined or sealed at substantially all of an outer contacting edge such that they form a bag or pouch. It is contemplated that the bag is substantially hollow. Nevertheless, it is also contemplated that the bag may have other contents, or the front and rear liquid impermeable layers may also be joined away from an outer contacting edge, provided the function of the bag to receive and contain the stomal output is not affected. In some embodiments, the front and rear liquid impermeable layers2,4may be sealed around the entire outer contacting edge. Suitably, the impermeable layers2,4are joined around the entire or whole outer contacting circumference except for an area5at the bottom of the bag or pouch to provide a means of emptying the contents of the bag when needed.

In embodiments, and in the embodiment shown inFIGS.1and2, the rear impermeable layer4comprises an aperture or opening6for accepting ostomy output. Suitably, the opening6is in the top half of the rear impermeable layer4. More suitably, the opening6is in the top 25% by length of the rear impermeable layer4. The opening6may be in the top 20%, 15%, 10% or 5% by length of the rear impermeable layer4.

In embodiments, the opening6is configured to embrace and surround the patient's stoma. The opening6may be adjusted in size by the user to that required so that it closely surrounds the stoma thereby providing an optimised fit. The generally circular markings8shown around the opening6in the embodiment shown inFIGS.1and2provide the user with a guide for adjusting the size of the opening6. The size of the opening6may be adjusted by any suitable means. Suitably, the size is adjusted by cutting with scissors or as knife prior to use. Alternatively, the markings8can be perforated during manufacture so that each marked segment can be removed by manual tearing without tools. Each of the circular markings8share a bottom edge that is in line with the bottom edge of the opening6meaning that after adjustment, where necessary, the position of the bottom edge of the opening6remains unchanged. An optimised fit around the stoma by the opening6is one way in which the leakage of stomal fluid is minimised or prevented by the bag of the present invention.

In embodiments, and in the embodiment shown inFIGS.1and2, arranged around the bottom edge of opening6is a spout10. The spout10has an angled section that projects inwardly and radially outwardly from the centre (or approximation thereto) of the opening6into the ostomy bag1. The angled section of the spout10projects at one end from, or close to, the bottom of the opening6at or close to skin level when in use. In this way, the spout10acts to direct the output from the stoma, under gravity, away from the skin into the ostomy bag1.

The angled section of the spout10may be any suitable shape and size. Suitably, the angled section of the spout10is generally quadrangular in shape. In embodiments, the angled section of the spout10is between 1 cm and 5 cm long. Suitably, the angled section of the spout10is between 1 cm and 3 cm long. In embodiments, the angled section of the spout10has a maximum length of 0.5 cm or less, 1 cm, 1.5 cm, 2 cm, 2.5 cm. 3 cm, 3.5 cm, 4.0 cm or more. In embodiments, the angled section of the spout10has a maximum length of 7.0 cm or more, 6.5 cm, 6.0 cm, 5.5 cm, 5.0 cm or less. In further embodiments, the angled section of the spout10is between 1 cm and 5 cm wide. Suitably, the angled section of the spout10is between 1 cm and 3 cm wide. the angled section of the spout10has a minimum width of 0.5 cm or less, 1 cm, 1.5 cm, 2 cm, 2.5 cm. 3 cm, 3.5 cm, 4.0 cm or more. In embodiments, the angled section of the spout10has a maximum width of 7.0 cm or more, 6.5 cm, 6.0 cm, 5.5 cm, 5.0 cm or less.

Due to the angle of the spout10in certain embodiments, the height of the spout10(defined as the perpendicular distance between the opening6(or extended plane thereof) and the end of the spout furthest from the opening6, is between 1 cm and 5 cm. Suitably, the height of the spout10is between 1 cm and 3 cm long. In embodiments, the minimum height of the spout10is 0.5 cm or less, 1 cm, 1.5 cm, 2 cm, 2.5 cm. 3 cm, 3.5 cm, 4.0 cm or more. In embodiments, the maximum height of the spout10is 7.0 cm or more, 6.5 cm, 6.0 cm, 5.5 cm, 5.0 cm or less.

The projection of the spout10into the ostomy bag1also acts to prevent the ostomy bag1from flattening and therefore in use promotes free passage of the ostomy output into the bag. “Pancaking” (or “pattycaking”) occurs when stomal output sits on or around the stoma pad and fails to fall into the ostomy bag. This residual output can block or prevent further output which then can leak from the ostomy attachment and/or seal. Pancaking can be caused by the front layer of the bag resting over the stoma and therefore any means of preventing this occurring would be of benefit.

The spout10may be fixedly attached to the ostomy bag1in any suitable way. In embodiments, and as shown inFIGS.1and2, the spout10is fixedly attached to an attachment plate or plate12on the exterior of the ostomy bag1. In an embodiment, a portion of the rear liquid impermeable layer4comprising opening6is sandwiched between the spout10and the attachment plate12thereby fixing both the spout8and the attachment plate12to the ostomy bag1. In alternative embodiments the attachment plate12and the spout10maybe formed as a single unitary piece and the attached to an ostomy bag by any suitable means, for example, plastic moulding, adhesive, semi-permanent attachment such as hook and loop tape, or mechanical attachments such as pins, screws of fixings.

In embodiments, the spout10comprises one or more curved arms14that project from a central portion of the spout10. The curved arms14act to direct stomal output to the angled section of the spout and increase the surface area of the spout10that may attach to the attachment plate12and thereby strengthen the fixing to the attachment plate12. The fixing between the spout10and the attachment plate12may be by any suitable means, for example, chemical such as plastic or heat welding or adhesive; or mechanical such as via clips, or screws.

In some embodiments, the spout10may extend outwardly from the ostomy bag1to the end, or just beyond, the face of the attachment plate12near the skin to optimise collection of ostomy output and prevent or reduce the amount of ostomy output contacting the skin.

The spout10and attachment plate12may be formed of any suitable material. They may be formed of the same or a different material, provided the choice of material does not prevent suitable attachment therebetween. Suitably, the spout10and the attachment plate12are each formed of a non-absorbent material that is resistant to deformation and/or degradation from contact with output from the stoma. Suitably, the spout10and the attachment plate12are formed of a resiliently deformable or flexible material. Any material with the required properties would be suitable to form the spout10and the attachment plate12; specific examples include rubber, rubber-like materials, polyurethanes, silicones and thermoplastic elastomers.

In embodiments, the front and rear liquid impermeable layers2,4are formed of a transparent, flexible plastic sheet. Materials for use in ostomy bags are well known and any material suitable for use in an ostomy bag is to be considered suitable for the invention.

The attachment plate12provides a surface away from the ostomy bag suitable for securing to an ostomy bag seal. The ostomy bag seal is commonly a complete annular ring, or can be split into two or more pieces. The ostomy bag seal is typically flexible to assist in adapting the inner circumference of the ostomy bag seal to obtain an optimised fit around the stoma.

In an embodiment, an inner surface or face of an ostomy bag seal abuts and adheres to the skin and the outer face, substantially parallel to and opposite the inner face, provides an attachment site for the attachment plate12, either directly or via a further seal already affixed to the attachment plate12. The inner and outer circumference of the or each seal may be selected such that sufficient surface area is provided on the annular seal4to result in good adherence of the outer face of the ostomy bag seal with the attachment plate12.

In embodiments, an ostomy bag seal (not shown) may be provided on the attachment plate12, or the attachment plate12may provide a surface for attachment to an ostomy seal already affixed to the skin or provided separately. In a further embodiment, an ostomy seal may be placed on the patient, and a further ostomy seal may be placed on the attachments plate to surround the opening6and the two seals are brought into contact in substantially aligned registry at which point they fuse together to form the seal. When the ostomy bag1is provided with a seal on the attachment plate12, the seal is suitably hydrocolloid to fuse with the same material commonly used in ostomy seals.

The attachment plate12may have suitable fixings (not shown) for attachment of a securing belt or other means of physical attachment to the patient, that holds the bag in place on the patient when in use, either in combination with or instead of the adhesive seal described above. In embodiments, the attachment plate has a finger grip16for holding the ostomy bag1, and to assist the use in removal of the ostomy bag1when replaced. The finger grip16may be positioned slightly inwardly of the face of the attachment plate to allow the user to grip both sides.

The ostomy bag1may be covered with a coating to strengthen the front and rear liquid impermeable layers2,4and/or to shield or obscure the contents of the ostomy bag1from view when in use. The cover may also provide strengthening to reduce the risk of puncturing of the ostomy bag1, or may be for decoration or to improve the aesthetic look or the feel of the ostomy bag1. Any form of covering is contemplated. InFIGS.1and2, the embodiment shown has a cover material18that is fixed to the rear impermeable layer4, and a cover material20that is fixed to the front impermeable layer2. In the embodiment shown the cover material20is formed and fixed in two over-lapping parts such that a window is left through which the contents can be viewed if desired. The coating18,20may be formed of any suitable material. Suitable materials are non-woven fabrics such as cotton, nylon, polyester, or mixtures thereof. In alternative embodiments, the ostomy bag may be covered with a removable cover.

In embodiments, for example the embodiment shown inFIGS.1and2, the area5at the bottom of the ostomy bag to allow emptying of the contents is sealed in use by a tongue22and retaining arms24arrangement. The tongue22is rolled up or folded from the end until positioned between the arms24. The arms24are then fixed to each other at the ends but any suitable means, for example, hook and loop tape or adhesive, thereby retaining the rolled tongue22in a sealed position. When the bag is to be emptied, the arms24are released and the tongue22unrolled to allow the contents of the ostomy bag to be drained.

The ostomy bag of the present invention may optionally comprise a filter system (not shown) which allows the release of gases from the interior of the ostomy bag to prevent “ballooning”. The filter may comprise means for absorbing odours (for example charcoal), or preventing escape of liquids.

The present invention provides an improved ostomy bag that comprises a spout that is able to direct the output from the stoma, typically under gravity, away from the skin to be collected into the ostomy bag. By more effectively protecting the absorbent, suitably hydrocolloid, seal material the non-absorbent spout section reduces the risk of the hydrocolloid breaking down and thereby improves the longevity of the ostomy seal saving costs for the patient and/or the healthcare provider. The present invention also provides for an improved ostomy attachment that is easier for the patient to use and position.

In a further advantage, the spout provides a physical barrier that prevents or reduces the stomal output splashing back on the annular seal and/or skin.

It is a further advantage of the present invention that the protruding nature of the spout separates the sides of the ostomy bag so that both parts of the bag cannot come into contact with each other in the area around the stoma. This reduces or mitigates the risk of the flow of the output into the bag from being impeded by the sides of the bag coming together. This can be a significant issue with prior art ostomy bags, the effect being known as “pancaking”.

The fact that the advantages of: (1) collecting and directing stomal output away from the annular seal and/or skin; (2) avoiding splashback of stomal fluid from the bag onto the annular seal and/or skin; and (3) preventing pancaking all derive from a single feature of a central section, in particular, when the central section is in the form of a spout, is a particular advantage of the present invention.

It should be understood that the different embodiments of the invention described herein can be combined where appropriate and that features of the embodiments of the invention can be used interchangeably with other embodiments where appropriate.

Although particular embodiments of the invention have been disclosed herein in detail, this has been done by way of example and for the purposes of illustration only. The aforementioned embodiments are not intended to be limiting with respect to the scope of the appended claims, which follow. It is contemplated by the inventors that various substitutions, alterations, and modifications may be made to the invention without departing from the scope of the invention as defined by the claims.