WO2022040722A1

WO2022040722A1 - Method for emptying and changing an attached ostomy pouch

Info

Publication number: WO2022040722A1
Application number: PCT/AU2021/050629
Authority: WO
Inventors: Stephen Sterling
Original assignee: Aquila Active Health Care Pty Ltd
Priority date: 2020-08-27
Filing date: 2021-06-17
Publication date: 2022-03-03
Also published as: AU2021103421A4

Abstract

A method for emptying contents from an emptiable ostomy pouch while attached to the skin of a user surrounding a stoma, the method comprising the steps: placing an ostomy pouch on to a support, the pouch comprising a top surface and a bottom surface and the bottom surface contacting the support, and wherein the ostomy pouch at a first end is attached to the skin of a user surrounding a stoma and at a second end has been opened for emptying the contents of the pouch; exerting a first directional force at a contact position on the top surface of the pouch at a first contact location using an emptying means to force the top and bottom surfaces of the pouch together against the support; exerting a second directional force by moving the emptying means across the top surface of the pouch from the first contact location towards the open second end while maintaining the first directional force to force the top and bottom surfaces of the pouch together between the emptying means and support; and forcing contents of the pouch out of the open second end.

Description

Method for Emptying and Changing an Attached Ostomy Pouch

Technical Field

[0001 ] The present invention relates to methods for emptying attached ostomy pouches and apparatus for use in the methods. More particularly, the present invention relates to methods for changing or emptying an ostomy pouch that reduces the potential for leakage, skin damage and infection, and improves convenience for the user.

Background Art

[0002] Ostomy surgery is a procedure that allows bodily waste to pass through a surgically created stoma on the abdomen skin where it is usual that the waste is collected into a prosthetic known as an ‘ostomy pouch’ or ‘ostomy bag’ commonly located on the outside of the body. An ostomy may be necessary due to birth defects, cancer, inflammatory bowel disease, diverticulitis, incontinence and many other medical conditions. They are also necessary in cases of severe abdominal or pelvic trauma resulting from accidents or injuries. Over 100,000 ostomy surgeries are performed annually in the United States alone and there are approximately one million people in the country who have an ostomy. These people living with a stoma and ostomy are referred to as ostomates. Australia currently has approximately 46,000 ostomates.

[0003] The three most common types of ostomy include the colostomy, urostomy, and ileostomy.

[0004] A colostomy is an opening in the large intestine, or the surgical procedure that creates one. Commonly, a colostomy is created when a portion of the colon or the rectum is removed, and the remaining colon is brought to the abdominal wall and through an incision in the anterior abdominal wall where it is sutured in lace. It may further be defined by the portion of the colon involved and/or its permanence.

[0005] Urostomy describes a surgical procedure that diverts urine away from a diseased or defective bladder. The most common urostomies are ileal or cecal conduit procedures. Either a section at the end of the small bowel (ileum) or at the beginning of the large intestine (cecum) is surgically removed and relocated as a passageway (conduit) for urine to pass from the kidneys to the outside of the body through a stoma. It may also include removal of the diseased bladder.

[0006] Ileostomy involves a surgically created opening from the ileum, the lowest part of the small intestine. The intestine is brought through the abdominal wall to form a stoma. Ileostomies may be temporary or permanent, and may involve removal of all, part, or none of the colon.

[0007] Ostomy pouches are available in a variety of different styles and sizes and made of different materials including plastics, as different systems work better for different people. Materials to adhere the pouch to the skin vary greatly in type of glue and the properties of the glue.

[0008] Ostomy pouches are often described as forming part of a pouching system which typically comprises (i) a one-piece system where the pouch attaches directly to the skin around the stoma, or (ii) a two-piece system where a flange (or wafer, or skin barrier) attaches to the skin around the stoma and the bag attaches to the flange. The pouch in both systems collects and stores the bodily wastes as they pass through the stoma.

[0009] While an ostomate usually will be able to continue with many of the same activities they did before the ostomy surgery, there will need to be some precautions to avoid anything that could damage the pouch, and the ostomate may need to visit the toilet more frequently than before stoma-forming surgery to manage their ostomy pouch. This will also include having to carry extra ostomy pouches in case of skin irritation, skin treatment necessity, a leakage, or bag burst and therefore in need of a pouch change and spare supplies when traveling. Thus, a key difference for the ostomate is the need for planning and awareness of where the nearest serviceable toilet is at all times, considerably more so than before the stoma-forming surgery.

[0010] One of the greatest difficulties with living with an ostomy pouch involves the steps involved when regularly changing and/or emptying the pouch. Changing of the pouch in the normal circumstance can be every 2 to 5 days (though this can vary significantly) and in normal circumstances is planned to be performed in the home at a time of day known as inactive stoma time. It is not possible however to predict a time that the stoma is not active. For example, leakages/irritation/bag bursts might occur and therefore the ostomate has to be prepared to change the pouch when out of their home and in the community. They may encounter great difficulties out of their home during this procedure if not fully prepared and especially if the stoma is active during the time of the need to change the pouch. Many ostomates will agree the mere anxiety associated with the change of the pouch leads to increased stoma activity due to increased gut motility and indeed this is agreed amongst many surgical and nursing professionals. The general medical recommendation involves emptying or changing the pouch when it is between one-third and one-half full. This precaution can help prevent the bag from pulling away from the skin and leaking. Therefore, while more inconvenient to travel with, a larger bag may be used for overnight or while sleeping as it can last for longer before having to be emptied. Likewise, a smaller bag may be more useful during the day with certain clothing or during exercising. Some pouches are reusable while others are disposable after a single use.

[0011 ] The process of changing a single use pouch involves: a. Preparing materials including: cutting a hole in the pouch precisely to fit the stoma; preparing a spare of each item in case the first application is not successful; having cleaning materials on hand, b. peeling the pouch from the stoma with great care not to damage the skin. An adhesive remover wipe or spray is recommended. If a ring has been applied this must be removed equally carefully, c. remove the opening or cut the bottom of the pouch and empty it into a toilet or a waste disposal bag, d. clean and dry the stoma and the skin around it thoroughly as well as shave any hair as needed; treatment of an wounds to the clean and dried skin as prescribed by appropriate medical professionals, e. application of skin barrier (wipe spray or cream to dry skin, then application of ring/ring-type cream around the stoma for attaching the ring to the junction between the skin and the stoma, f . attach the next pouch carefully to the outside of the stoma ensuring the pouch’s orientation is directed down vertically so that a full pouch pulling on the skin is even and not causing a rotational torsion. Ensure the pouch edge does not catch and damage or glue to and collect part of the stoma which can be disastrous. Locating of the pouch precisely to ensure no excess pressure is placed on any part of the stoma or the junction between stoma and skin, g. pressure is applied to the pouch edge working outwards gradually once the ostomate is satisfied the seal at the junction of the stoma and skin is complete. The tiniest gap anywhere at this stage can lead to contamination of the skin and can then lead to a leak/bag burst. Any contamination of the skin by human waste will lead quickly to skin damage and significant risk of infection. If there is skin damage, the pouch will not adhere or is at risk of un-adhering, h. wideners may be used to protect the seal or to give the ostomate a little more security, but this can only be considered a short-term measure as the skin will quickly break down once contaminated. i. the ostomate must ensure all of the stoma has passed into the pouch and has not been collected by the glue or by a tight-fitting hole. Failure to complete all these elements of the task thoroughly and cleanly will lead to skin damage. Skin damage is a disaster. It prevents the glue from adhering. It leads to infection if faecal matter comes into contact with the damaged skin.

[0012] With experience, the ostomate will become accustomed to identifying when a pouch needs changing even if this time does not align with timing of the inactive stoma or recommended frequencies of changing the pouch. However, selecting a time of day when the stoma is not active to minimize a sudden midprocess stoma activation, causing waste to pour down the body and inside leg, or contaminate one or all of the various components of the change is not easy.

[0013] Ostomates will often experience the frustration of the stoma becoming productive during the pouch change process, leading to contamination of pre- prepared surfaces for the next pouch. Education is provided to find a time of day that the stoma is not active but even if successful in this, the stoma can still surprise ostomates. The unfortunate result is effluent contaminating the skin and any other parts, for example, rings and barrier cream that have been applied. This requires starting the process again or cutting corners and trying to clean up the contaminated part and attach the bag before more effluent emanates from the stoma. This can lead to rushing the process of the pouch change.

[0014] Rushing the change process can lead to a number of adverse outcomes. Some of the effluent can be inadvertently missed, placing the skin at risk of damage. Rushing can also lead to the inside edge of the cut-out hole in the pouch/skin interface pushing against or pulling from the skin/stoma junction. It can further lead to mistakes such as little folds of the interface material, which the ostomate, if they discover in time, may try to pull out the fold and in doing so compromise the integrity of the sticking material. This can weaken the seal and lead to skin damage through effluent contamination and also mechanically lead to leakages of effluent from the seal adjacent to the bag on skin and/or clothing.

[0015] The process of emptying an emptiable ostomy pouch involves: a. While the pouch remains attached to the skin surrounding the stoma, opening the end of the pouch which is usually located away from the stoma and emptying the contents of the pouch into a toilet or a disposal bag by hand squeezing the pouch, b. closing the end of the pouch.

[0016] For the purpose of describing the invention, an ‘emptiable ostomy pouch’ or ‘emptiable pouch’ comprises an ostomy pouch that can be emptied multiple times while in use by emptying contents from an opening other than where it connects around the stoma.

[0017] Step a. of the process of emptying an emptiable ostomy pouch may appear fairly straightforward but it is not. While urine may be easier to empty from a bag whose opening means may be subsequently closed and cleaned, emptying faecal waste from a plastic pouch is not as easy, and neither makes it a particularly convenient process when having to lean across the bowl of a toilet and squeeze the dangling pouch to ensure the contents ends up in the bowl. Users can set up systems that work for them in the comfort and privacy of their own bathrooms to empty their ostomy pouches but making use of bathroom facilities at another person’s house, at work, in public restrooms with other people present, at restaurants and other businesses, can be stress causing and even mentally distressing. In this respect, the risk of pouch leakage or bag bursts is a major cause of ostomate social restriction as this can be highly embarrassing. This will often result in some ostomates restricting their lives by not traveling for periods of time longer than when their ostomy pouch next requires emptying. This allows them to avoid potentially awkward bathroom scenarios occurring while emptying an ostomy pouch, but can detrimentally affect their lives in missing out on or restricting activities they normally would have done if not for their ostomy.

[0018] Another key issue relates to irritation of the skin whilst squeezing on the pouch to empty the contents which tends to pull on the skin and causing irritation. Gravity may or may not assist in the emptying of the contents of the pouch. If the ostomate is drinking sufficient fluids and appropriate foods according to the guidelines provided by their doctor or health professional, the effluent in their ostomy bag should have a consistency similar to toothpaste. However, the more concentrated the consistency of the effluent, the harder it is to squeeze out.

[0019] Clearly, living as an ostomate is not easy in any sense. It would therefore be beneficial to provide better means for ostomates to be able to empty or change their ostomy pouch, particularly when outside the comfort of their homes, and without irritating or damaging their skin.

[0020] The preceding discussion of the background art is intended to facilitate an understanding of the present invention only. It should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was part of the common general knowledge as at the priority date of the application. Summary of the Invention

[0021 ] In a preferred embodiment, the present invention provides a method for emptying contents from a multiple use ostomy pouch while attached to the skin of a user surrounding a stoma, the method comprising the steps: placing an ostomy pouch on to a support, the pouch comprising a top surface and a bottom surface and the bottom surface contacting the support, and wherein the ostomy pouch at a first end is attached to the skin of a user surrounding a stoma and at a second end has been opened for emptying the contents of the pouch; exerting a first directional force at a contact position on the top surface of the pouch at a first contact location using an emptying means to force the top and bottom surfaces of the pouch together against the support; exerting a second directional force by moving the emptying means across the top surface of the pouch from the first contact location towards the open second end while maintaining the first directional force to force the top and bottom surfaces of the pouch together between the emptying means and support; and forcing contents of the pouch out of the open second end.

[0022] For the purpose of describing the invention herein, use of the term ‘ostomy pouch(es)’ will also refer to ostomy bags and other similar devices for holding bodily waste including effluent, fluids, urine, and/or faces emanating from an ostomy.

[0023] The support preferably comprises a substantially planar portion. The planar portion preferably provides a surface upon which the bottom surface of the pouch may be placed enabling a consistent force to be maintained across the top and bottom surfaces of the pouch by the emptying means during the method the invention.

[0024] Reference to a ‘bottom surface’ of the pouch describes a surface of the pouch that substantially faces in a generally downward direction towards the ground and/or the user’s feet when the user to which it is attached is standing. Similarly, reference to a ‘top surface’ of the pouch describes a surface of the pouch that substantially faces in a generally upwards direction towards the user’s head when the user to which it is attached is standing.

[0025] More preferably, the support further comprises a ramped portion comprising a gradient. The gradient of the ramped portion of the support may be substantially linear. Alternatively, at least a portion of the ramped portion may comprise a curve comprising an increasing and/or decreasing or declining gradient.

[0026] In a preferred embodiment, the ramped portion comprises a curved edge which can be placed advantageously against the skin of the user immediately below the attached first end of the pouch. The gradient (or angle) of the ramped portion preferably comprises a declining gradient or curved surface from the curved edge at the skin of the user. The bottom surface of the pouch preferably contacts at least a portion of the declining gradient of the ramped portion and gravity assists the second directional force in forcing contents of the pouch out of the open second end.

[0027] The ramped portion of the support preferably enable a user to place their stoma on the support adjacent the edge of the support during the process of changing their pouch. Therefore, if the stoma becomes active and waste emanates from the stoma while no pouch is attached, the waste will descend down the ramped portion and will not contact the user’s skin, or contaminate the preparations already undertaken for the pouch change.

[0028] In one preferred embodiment, the support may be attached or releasably attached to a collection vessel.

[0029] In another preferred embodiment, the support forms part of a collection vessel. The support preferably forms part of a collection vessel support of a collection vessel.

[0030] In a preferred embodiment, the top surface of the collection vessel comprises a support (‘collection vessel support’) and preferably the collection vessel support comprises a ramped portion. The ramped portion preferably comprises an upwards gradient that increases in height towards an edge of the collection vessel support. More preferably, a portion of the collection vessel support extends from the rear of the collection vessel.

[0031 ] According to a method of the invention, an ostomy pouch of a user is placed with the bottom surface of the pouch contacting the, collection vessel support of the collection vessel so that the top surface of the pouch is exposed. In a step of the method of the invention, a first directional force is exerted on the top surface of the pouch at a contact position at a first contact location by an emptying means to force the opposing top and bottom surfaces of the pouch together at the contact position at the first contact location against the collection vessel support of the collection vessel.

[0032] The contact position preferably comprises an area which may comprise a variety of different possible shapes. More preferably, the contact position comprises a line of contact substantially (long) transverse to the open end of the pouch. The contact position preferably extends from one side of the pouch to the other side of the pouch at the lateral edges where the top surface and the bottom surface of the pouch meet which may be formed by the flattened pouch. The first contact location is preferably located as close to the point of attachment of the pouch to the skin of the user as possible without causing pressure on the attachment or the skin and/or discomfort for the user.

[0033] In a further step in the method of the invention, the emptying means moves the contact position from the first contact location along the length of the pouch towards the open end of the pouch by a second directional force while maintaining the first directional force. The movement of the emptying means along the top surface of the pouch from the first contact location to the open end of the pouch forces the contents of the pouch between the contact position at the first contact location and the open end of the pouch towards and out of the open end of the pouch. The contact position is preferably maintained by maintaining the first directional force employing the emptying means to force the opposing top and bottom surfaces of the pouch together at the contact position against the collection vessel support of the collection vessel.

[0034] An important feature of the movement of the emptying means along the top surface of the pouch is the minimisation of friction to minimise any pulling force of the pouch away from the skin at the point of attachment. The first directional force exerted against the collection vessel support of the collection vessel by the emptying means reduces the potential for any pulling force of the pouch away from the skin that occurs in the standard method of hand squeezing to empty a pouch.

[0035] For pouches that are emptiable from an opening not at the second end, the second directional force may be applied by the emptying means toward the position of the opening. Further, an emptiable pouch may be designed for use with a method according to the invention which is constructed from materials that are of the lowest friction possible to assist in the method.

[0036] Disposal of Waste

[0037] In a preferred embodiment, the contents of the pouch forced out of the open second end are collected in a cavity in the collection vessel in a method according to the invention. Thus, the method of the invention preferably comprises the additional step of emptying the cavity of the collected contents of the pouch.

[0038] In one embodiment of the collection vessel, the collection vessel support comprises a hinged flap which covers at least a portion of the cavity of the collection vessel. The hinged flap can preferably be opened to improve access to the cavity of the collection vessel to assist when emptying the pouch contents collected in the cavity.

[0039] In one embodiment, the contents of the pouch are collected in the cavity and the collection vessel which is then emptied, and the cavity and collection vessel cleaned ready for next use.

[0040] Alternatively, for ease of use and benefits of reduced cleaning, in a preferred embodiment the cavity comprises a removable insert into which the contents of the pouch are collected. The removable insert may be formed from a variety of different materials, or comprise waste disposal bags including biodegradable waste bags.

[0041 ] In a preferred embodiment, the removable insert comprises a flushable insert, wherein ‘flushable insert’ also comprises flushable bag. The flushable insert can preferably be placed into a toilet where it is flushed. The flushed insert preferably enters the sewage system or other attached system (for example, a septic tank) where it disintegrates therein releasing the contents of the flushable insert. The flushable insert will preferably be one that can disintegrate upon sustained contact with liquid and moisture, and does not risk blocking the drainage pipes at any stage on its journey from the toilet to the sewer, septic tank or other form of waste management services.

[0042] The flushable insert may comprise a variety of different possible materials which will result in the insert disintegrating in a timely manner, that is preferably consistent with the local laws relating to disintegration requirements of that country or jurisdiction. Some non-limiting examples of materials that the flushable insert may be constructed from comprises thin water soluble film such as polyvinyl alcohol (PVOH), polyvinyl acetate/acid (PVA), polyvinyl alcohol, and/or glycerine (PVAL). The surfaces of the flushable insert may require additional linings to ensure the accumulation of those surfaces do not cause delayed disintegration that could risk blocking, for example, pipes leading from a toilet or within a sewage or other waste management system.

[0043] Emptying means

[0044] The selection of emptying means for use in the method of the invention is critical in the reduction of friction against the top surface of the pouch as the second directional force is applied. In this respect, the reduction of friction by the movement of the emptying means along the top surface of the pouch reduces any pulling force of the pouch away from the skin at the attachment point.

[0045] In a preferred embodiment, the emptying means comprises a roller. The roller may be attached to the support and/or the collection vessel. Preferably the roller is releasably attached to the support and/or the collection vessel. In another embodiment, the roller is not attached and separate to the support or the collection vessel.

[0046] In one embodiment, the roller is attached to the collection vessel support of the collection vessel and can roll an ostomy pouch placed on the collection vessel support of the collection vessel. The roller is preferably attached to the collection vessel support of the collection vessel. More preferably, the roller is attached at one end by a hinge to the collection vessel support so that the other end may be lifted out of the way while the ostomy pouch of a user is placed on the collection vessel support. Then the roller is placed down over the ostomy pouch to roll the contents of the pouch towards and out of the open end of the pouch into the cavity of the collection vessel.

[0047] The roller may be releasably attached to the collection vessel during storage or while the user is undertaking tasks other than the step of rolling the pouch. The emptying means, whether attached to the collection vessel or unattached, may be adjustable, for example, to accommodate different sized pouches with different volumes of contents.

[0048] The roller may comprise a handle similar to a ‘painter’s roller’. The rolling portion of the roller preferably comprises a smooth, soft and/or resilient material, for example, wool or foam amongst other examples, to reduce the chance of damaging or breaking the pouch due to frictional forces during use in applying a second directional force according to a method of the invention.

[0049] A user may create the first directional force and second directional force by pushing or pulling the roller depending on which way the roller is orientated, for example, in proximal rolling or moving waste from the sides of the pouch back towards the middle of the pouch to be then pushed out of the opening. In another embodiment, the rolling portion does not roll but can still move freely along the surface of the ostomy pouch to force the contents of the pouch towards and out of the open end of the pouch. The width of the rolling portion is preferably at least the width of the ostomy pouch being rolled though the width of the rolling portion may be equal, less than, or more than the pouch. For example, a roller of approximately 100 mm may be used with a pouch of 150mm wide. Care is preferably taken to ensure too much pressure at the opening is not created when rolling towards the opening, which could lead to uncontrolled rate of elimination or possibly too much pressure on the seams of the pouch, thereby damaging the pouch and leading to leakage.

[0050] Any creases in the surfaces of a pouch to be emptied in a method of the invention should be first removed to avoid downward pressure of the roller damaging the folds causing kinks and possible cracks in the material. [0051 ] In another preferred embodiment, the emptying means may also comprise a sliding portion, preferably comprising low friction dry-running sliding materials for moving along the top surface of the pouch and minimising friction and resulting pulling forces of the pouch away from the skin. Some non-limiting examples of applicable low friction materials when the surfaces of the materials are appropriately treated and/or smoothed comprises, plastics, ceramics, glass, stone, and wood.

[0052] In a further preferred embodiment, an intermediary layer is laid across the top surface of the pouch to form a layer between the emptying means and the pouch to further reduce the friction caused by the emptying means and potential damage to the top surface of the pouch as it moves towards the open end of the pouch. The intermediary layer may be of particular benefit when the top surface of the pouch is rough or tacky to reduce friction and pulling of the pouch away from the skin when under the second directional force. The intermediary layer may comprise, amongst others, felt or smooth plastic, and is preferably flexible.

[0053] Thus, a fundamental purpose and benefit of the collection station and the emptying means is in allowing the ostomate to squeeze far more effluent out of their pouch, more quickly and more efficiently, without pulling on and irritating the skin. It also allows the ostomate to clear more waste from the open end of the pouch thereby making the cleaning of the opened end of the pouch more hygienic and faster.

[0054] Collection Vessel Attachment

[0055] Further, as an ostomy user, the inventor wanted to create a solution that improved the user’s dignity and quality of life in not having to kneel, sit, lie or straddle across a toilet, multiple times a day, and carefully squeeze their pouch to empty the contents to avoid splash back, or contents seeping out of the pouch at the attachment of the pouch and skin and risk infection.

[0056] The method of the invention and apparatus for use in the method has allows users to use toilets without having to stoop/lean over those toilets/kneel, thereby making the experience far more comfortable and dignified. Use of the method of the invention and apparatus for use in the method that attaches to the body providing the required stability to perform the invention, also provides additional freedoms, particularly when travelling distances from home and work without worrying about the location/availabi lity/condition of the nearest toilet.

[0057] In a preferred embodiment, the collection vessel preferably comprises an attachment means for releasably attaching the collection vessel to the user to assist in performing the method of the invention.

[0058] In one preferred embodiment, the attachment means comprises a strap for releasably securing the collection vessel to the user. The collection vessel preferably comprises a strap attachment portion to which the strap is connected. The strap attachment portion can preferably be releasably separated from the collection vessel. The strap attachment portion preferably comprises a slot through which the strap can pass. The strap preferably comprises a belt of adjustable length. In one embodiment, the user may use their own belt as the strap, wherein the belt is passed through the strap attachment portion to releasably attach the collection vessel to the user.

[0059] In a further preferred embodiment, the bottom surface of the collection vessel or support comprises an attachment means for attaching to a frame. The attachment means preferably comprises a threaded hole for attachment to a screw on the frame. In another attachment, the support and/or collection vessel slidably attaches to the frame. In one embodiment, the frame comprises a tripod. In another embodiment, the frame is attached to a wall or other surface. The frame is preferably adjustable to adjust the position and/or height of the collection vessel relative to a user and their ostomy pouch.

[0060] The invention further provides a support and/or collection vessel for use in a method according to the invention as described herein.

[0061 ] The invention further provides a use of a support and/or collection vessel for performing a method according to the invention as described herein.

[0062] The invention further provides a kit for use in the method according to the invention as described herein, the kit comprising an emptying means, collection vessel comprising a support or in addition to a support, and at least one disposable, and preferably flushable, bag. The kit may further comprise a carrier bag, the carrier bag containing pockets which contain the materials for emptying and for changing an ostomy pouch. The carrier bag preferably contains a sealable container for collection of a used disposable bag containing contents of a pouch or a changed pouch containing effluent. The carrier bag preferably comprises all of the required materials to carry out a method according to the invention even without access to a toilet.

[0063] The invention further provides a process for the manufacture of a support and/or collection vessel for use in the method according to the invention as described herein. The manufacture of the support and/or collection vessel preferably comprises a method selected from the non-limiting group comprising: using injection moulding, and more preferably plastic injection moulding, blow moulding, or 3D printing. Other materials that may be used in the manufacture of the collection vessel and/or support comprise, amongst others, wood, preformed wood, 3-D printing plastics and polymers, metal, glass, fibreglass, and/or carbon fibre.

[0064] Advantages

[0065] As earlier described, the standard method of emptying an ostomy pouch involves the user squeezing the pouch using their hands to force the contents out of the open end of the pouch to empty it into a toilet or waste bag. The inventor, who is both an ostomy user and a trained physiotherapist, found in their use that these squeezing forces placed unevenly by the user’s hand(s) on the pouch cause a detrimental effect with pressure, albeit unintentionally, forcing some contents and air towards the attachment of the pouch to the skin. This is almost impossible to avoid without the user squeezing at the very join of the attachment of the pouch to the skin; however, this creates its own issue as the pressure at this juncture can cause the attachment to pull away from the skin and/or damage to the skin in this immediate area which can increased chance of skin infection, pain and discomfort.

[0066] This act of generating a reaction force stretches the skin as well as the pouch, leading to premature deterioration of the material of the pouch and potentially significantly greater irritation of the skin because in-part the water within the skin layers becomes squeezed out. A clinical term used to describe this phenomenon is Trans Epidermal Water Loss (TEWL) and is known to be a contributory factor in skin damage. Additionally, the mere act of repeated and/or sustained stretching of the skin does lead to mechanical damage of one or more of the three main layers of skin.

[0067] Thus, it was the inventor’s focus on controlling the forces which move the contents of the ostomy pouch towards the open end during the emptying process, which led to the method of the invention and the apparatus for carrying out the method.

Brief Description of Figures

[0068] The present invention will now be described, by way of example, with reference to the accompanying drawings, in which:

Figure 1. (A) 3-dimensional rendered illustration, and (B) line drawing, of a perspective view from above of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 2. (A) 3-dimensional rendered illustration, and (B) line drawing, of a front view from above of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 3. (A) 3-dimensional rendered illustration, and (B) line drawing, of a front view from below of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 4. (A) 3-dimensional rendered illustration, and (B) line drawing, of a side view from above of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 5. (A) 3-dimensional rendered illustration, and (B) line drawing, of a side view of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 6. (A) 3-dimensional rendered illustration, and (B) line drawing, of a perspective view from the rear of a collection vessel for use in the preferred embodiment of the method according to the invention. Figure 7. (A) 3-dimensional rendered illustration, and (B) line drawing, of a rear view; (C) 3-dimensional rendered illustration, and (D) line drawing, of a bottom view; and (E) 3-dimensional rendered illustration, and (F) line drawing, of a top view; of a collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 8. (A) 3-dimensional rendered illustration, and (B) line drawing, of a perspective view from above; (C) 3-dimensional rendered illustration, and (D) line drawing, of a front view from above; of a collection vessel for use in the preferred embodiment of the method according to the invention with the hinged flap opened, and (E) a hinged flap.

Figure 9. Line drawings of a top view (A), front view (B), and a side view (C), and a 3-dimensional rendered illustration of a perspective view from above (D), of a taller collection vessel for use in the preferred embodiment of the method according to the invention; and line drawings of a top view (E), front view (F), and a side view (G), and a 3-dimensional rendered illustration of a perspective view from above (H), of a shorter collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 10. (A) 3-dimensional rendered illustration, and (B) line drawing, of a perspective view from above of a shorter collection vessel for use in the preferred embodiment of the method according to the invention.

Figure 11. 3-dimensional rendered illustrations of a side perspective view (A), and a side view (B), of a collection vessel for use in the preferred embodiment of the method according to the invention attached to the waist of a user by a belt.

Figure 12. 3-dimensional rendered illustrations of a side perspective view from above of a collection vessel for use in the preferred embodiment of the method according to the invention (A) attached to a tripod, and (B) attached to a frame, and positioned in front of the abdomen of a user. Figure 13. (A) 3-dimensional rendered illustration, and (B) line drawing, of a front view from below of a shorter collection vessel with metal attachment means for use in the preferred embodiment of the method according to the invention.

Figure 14. Photograph of a user rolling their ostomy pouch on the collection vessel support of a collection vessel towards the opened end of the pouch which is positioned over a waste bag in the cavity.

Figure 15. Photograph of a preferred embodiment of a support releasably attached to a collection vessel which is attached via an attachment apparatus to a wall ready for use in a method according to the invention.

Figure 16. Photographs of a flushable bag (A) in a cavity of a collection vessel, and (B) outside of a collection vessel for use in a method according to the invention.

Figure 17. Front perspective view of a preferred embodiment of an adjustable attachment device for attaching to a collection vessel for use in a method according to the invention.

Figure 18. Bottom perspective view of a preferred embodiment of a support for releasably attaching to a collection vessel for use in a method according to the invention.

Figure 19. Photographs of a further preferred embodiment of a support releasably attached to a collection vessel (A) assembled for use, (B) disassembled for placement in a kit, and (C) assembled for use and attached to a user for use in a method according to the invention.

Description of Preferred Embodiments

[0069] Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It is to be understood that the invention includes all such variations and modifications. The invention also includes all of the steps, features, compositions and compounds referred to or indicated in the specification, individually or collectively and any and all combinations or any two or more of the steps or features.

[0070] The present invention is not to be limited in scope by the specific embodiments described herein, which are intended for the purpose of exemplification only. Functionally equivalent products, compositions and methods are clearly within the scope of the invention as described herein.

[0071 ] Other definitions for selected terms used herein may be found within the detailed description of the invention and apply throughout. Unless otherwise defined, all other scientific and technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

[0072] It will be appreciated that the indefinite articles “a” and “an” are not to be read as singular indefinite articles or as otherwise excluding more than one or more than a single subject to which the indefinite article refers.

[0073] Reference to cited material or information contained in the text should not be understood as a concession that the material or information was part of the common general knowledge or was known in Australia or any other country.

[0074] Each document, reference, patent application or patent cited in this text is expressly incorporated herein in their entirety by reference, which means that it should be read and considered by the reader as part of this text. That the document, reference, patent application, or patent cited in this text is not repeated in this text is merely for reasons for conciseness.

[0075] Throughout the specification and claims, unless the context requires otherwise, the word “comprise” or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

[0076] Features of the invention will now be discussed with reference to the following preferred embodiments. [0077] In a first preferred embodiment of a method according to the invention, Figures 1 to 7 show a collection vessel 2 for use in the method. Used in a preferred embodiment of the method according to the invention, an emptiable ostomy pouch is attached to the skin of a user surrounding a stoma is placed on to the collection vessel support 4 of the collection vessel 2. The collection vessel support 4 comprises a hinged flap 6 and a ramped portion 8.

[0078] In the preferred embodiment of the method according to the invention, a removable insert in the form of a flushable insert, disposable and/or biodegradable waste bag, for example, amongst others, a bin liner of plastic or another material is placed in an open form in the cavity 10 of the collection vessel 2 (see Figure 14). The removable insert is used to collect the waste contents of the emptiable ostomy pouch so that it may be easily separated from the collection vessel and the waste disposed of in a bin or other disposal site preferably avoiding the collection vessel 2 needing to be cleaned, i.e. much in the way a bin liner captures the waste placed in a bin and can be removed and replaced with a fresh bin liner without the wate contaminating at least the inner surface of the bin. A flushable insert is preferably used so that the contents can be flushed down a toilet or dropped into an appropriately prepared pit (for example, when camping or out of the urban environment) meeting the standards of local waste laws. The removable insert in the form of a waste bag may also include handles or extensions to assist in tying the top of the waste bag into a knot to prevent the contents easily escaping when placed in a bin.

[0079] The hinged flap 6 provides two key benefits. The first key benefit is that when the hinged flap 6 is opened (Figure 8), it provides greater access to the cavity 10. The hinged flap 6 is thus opened to assist in positioning the waste bag within the cavity 10 making it easier to wrap the edges of the top of the waste bag over the top edge 12 at the opening to the cavity 10 in the collection vessel 2. Closing the hinged flap 6 also assists in trapping a portion of the top of the waste bag in place between the top edge 12 and the closed hinged flap 6 to prevent the waste bag collapsing into the cavity and contents spilling into the cavity which would require additional and undesired cleaning of the collection vessel. [0080] The second key benefit is that when the hinged flap 6 is closed, it provides the collection vessel 2 with a greater surface area of the collection vessel support 4 on which to place the ostomy pouch that is to be emptied in the preferred embodiment of the method according to the invention.

[0081 ] As shown in Figure 1 , when the hinged flap 6 is closed, the cavity 10 is still accessible through a cavity opening 14 through which the end portion of an ostomy pouch may enter to minimise any spillage and splashback when the contents of the pouch is emptied into the cavity 10.

[0082] The ramped portion 8 can be seen as part of the collection vessel support 4 which extends on a ramp angle or gradient in an upwards direction and extending out from the rear 16 of the collection vessel 2. The ramped portion 8 of the collection vessel support 4 comprises a curved ramp edge 18 which assists in providing a natural curve around the abdomen region of the user when they place their abdomen adjacent the collection vessel 2 in the preferred embodiment of the method according to the invention, with the user’s stoma and ostomy pouch positioned above the curved ramp edge 18.

[0083] The inventor determined that the curved ramp edge had the benefit during an ostomy pouch change that the stoma could be placed over curved ramp edge 18 in the moment of activation. This prevented a common occurrence for all ostomates of effluent/waste escaping and descending down the body, the groin and inner leg creating an undesirable mess requiring additional clean up. It also prevented the associated wasted time for the ostomate waiting for the stoma to cease action and associated frustration and/or anxiety during this time. Such associated anxiety with an ostomy change will in some ostomates lead to procrastination or delay in changing a pouch which can also contribute to skin damage and infection. This action of presentation of the ostomate’s stoma over the curved ramp edge 18 of the collection vessel 2, provides room underneath the curved ramp edge 18 to continue to make skin preparations. The reduced anxiety associated with this intervention also has been found to reduce the activation time for the ostomate.

[0084] A curved base extension 19 also extends from the rear 16 of the collection vessel 2 to also assist in providing a natural curve around the abdomen region of the user. Thus, when in use, the curved base extension 19 and curved ramp edge 18 placed against the abdomen of the user will keep the collection vessel 2 steady while the user is rolling the contents of the pouch into the cavity 10. The curved base extension 19 also importantly works in unison with the curved ramp edge 18 to maintain the collection vessel in place against the abdomen of a user in order to form a gap beneath the stoma. This gap (i) avoids the problems associated with activation of the stoma during changing of an ostomy pouch; and (ii) allows for the user to make preparations for a pouch change including room to have fingers, sprays, wipes, razor access to the skin around the stoma.

[0085] Thus, some of the benefits provided by the ramped portion include: a. Reduce the need to rush changes of pouches, therefore also reducing errors including poorly fitted pouches over insufficiently prepared skin, or mistaken angles of pouches, b. reduced opportunity for contamination of materials and skin, c. assisting to prevent the pouches being pushed up against the stoma /stoma skin junction thereby avoiding compression and tension wounds, d. reduced wastage of pouches, rings and other materials from reduced need for re-applications, e. reduced anxiety and other adverse effects on mental state with less stress over leakage if the stoma activates during changing, and reduced chance of error with more useful space and pouch placement leading to faster changes (5 to 10 minutes compared to previously up to an hour or more), f. less error leading to less wastage of materials from reduced reapplications, and g. no need for a change to diet I fasting I hygiene routine.

[0086] The ostomy pouch of the user is placed on the collection vessel support 4 with a portion of the stoma-attached end of the pouch descending down the ramped portion 8. When rolling the pouch in the preferred embodiment of the method according to the invention, gravity may initially assist the emptying of the contents of the pouch depending on the consistency of the waste as the roller presses down over the pouch firstly down the ramp (in the portion of the pouch adjacent the stoma) before rolling across the pouch on the substantially horizontal portion of the collection vessel support 4. This forces the contents of the pouch out of the open end of the pouch, which is positioned through the cavity opening 14, the contents of the pouch entering into the cavity 10.

[0087] The contents of the pouch is forced out of the pouch into the cavity 10 by rolling the roller across the surface of the pouch towards the open end of the pouch away from the stoma. Once the pouch is sufficiently empty as deemed by the user, the open end of the pouch may be closed, and the pouch is made ready by repositioning it against the user’s body for continued use as it was before it was emptied. A key benefit of the roller is that the pouch may be cleaned more quickly and efficiently with greater ease and hygiene than if not used.

[0088] The hinged flap 6 may be opened allowing the user easier access to the waste bag now containing the contents of the pouch. The edges of the top of the waste bag overlapping over the top edge 12 at the opening to the cavity 10 in the collection vessel 2 are unwrapped and the waste bag removed from the cavity 10. The top of the waste bag may be closed by a knot, a bag tie, or some other means for closing the waste bag, or the top of the waste bag may be left open, before being disposed of in a bin or other waste disposal means including the toilet or underground if the waste bag is disposable.

[0089] By using the waste bag in the cavity 10, no contents from the pouch should have contacted any surface of the collection device 2 and therefore, the collection device 2 is now ready for next use. However, if some pouch contents contacted a surface of the collection device 2, for example the underside of the hinged flap 6 which wasn’t covered like the cavity 6 with the waste bag, the surface may be cleaned with a disposable wipe which can also be disposed of with the used waste bag into a bin (but not the toilet to avoid sewage blockages and associated environmental damage). [0090] Different sizes of collection vessel may be used in the preferred embodiment of the method according to the invention. As shown in Figure 9, a taller collection vessel (Figure 9A) may be used by a user who find they regularly have more contents to be emptied from their ostomy pouch and/or if they stand up to empty their ostomy pouch. A shorter collection vessel (Figure 9B and Figure 10) may be preferred, for example, by a user in a wheelchair as the shorter collection vessel better fits in their lap below their stoma. The collection vessels shown in Figure 9 may (as shown) have no hinged flap, however, taller or shorter, the collection vessel may or may not comprise a hinged flap.

[0091 ] There are three key means for positioning the collection vessel appropriately for a user to empty or change their ostomy pouch in the preferred embodiment of the method according to the invention.

[0092] The first key mean is by an attachment device which releasably secures the collection device 2 to the user. In the preferred embodiment, this attachment device is a strap which the user can releasably attach around their waist, the strap attached to a strap attachment portion 20 of the collection vessel 2 (Figure 11 ). The strap may comprise the strap portion of a waist belt. The strap attachment portion 20 shown in Figures 4 to 7 comprises a slot 21 shaped aperture through which an end of a strap can pass through therein connecting the strap to the collection vessel 2. The strap can then be connected around the waist or another body part of the user to releasably connect the user to the collection vessel 2. The collection vessel 2 once connected by the strap to the user 2 is positioned with the curved ramp edge 18 against or adjacent the user’s abdomen and just below their stoma so that the user’s ostomy pouch may be easily and comfortably positioned on the collection vessel support 4 of the collection vessel 2 for emptying the contents of the pouch or changing the pouch in a method according to the invention. The strap attachment portion 20 in the preferred embodiment is a curved piece of moulded plastic which can be releasably attached to the rear 16 within a similarly shaped curved groove for accommodating the strap attachment portion 20.

[0093] The second key means for positioning the collection vessel appropriately for a user to empty or change their ostomy pouch is by attachment to a tripod 28. The tripod is preferably adjustable in height and collapsible for ease of transport and storage (Figure 12A). The tripod 28 may be a tripod commonly used for releasably attaching to, and holding other items, for example cameras and telescopes. Such tripods commonly comprise or can have attached thereto, tripod attachment screws for attaching to the base of cameras or telescopes or an attachment accessory such as a mobile phone holder. Most consumer cameras are fitted with 1/4-20 UNC threads with larger, professional cameras and lenses often fitted with 3/8-16 UNC threads, plus a removable 1/4-20 UNC adapter allowing them to be mounted on a tripod using either standard. Thus, the collection vessel 2 used in the preferred embodiment according to the method of the invention comprises an attachment point 22 comprising an attachment thread 24 of one of the above standard thread sizes or another size (Figure 13), for example, a size appropriate or more commonly used in the country or location, in the base 26 of the collection vessel 2. The attachment point 22 may be formed in the moulded plastic of the base 26 of the collection vessel 2. Alternatively, the attachment point 22 may comprise a separate piece attached to the base 26 as shown in Figure 11 where the attachment point 22 is formed from metal. Said metal attachment point 22 provides greater strength in attaching to the tripod or a frame and reduces the opportunity for damage to the attachment thread. Such damage would include stripping of the attachment thread 24 which would affect its ability to connect with a tripod or a frame and result in needing to replace the entire collection vessel 2 if made from the plastic of the collection vessel 2.

[0094] The collection vessel 2 attached to a tripod 28 may be placed in an appropriate location, for example, within a bathroom, or in a hospital room. There, the height may be adjusted so that the user may walk up to the rear 16 of the collection vessel 2, adjust the height of the tripod 28 so that the curved ramp edge 18 touches or is located adjacent the user’s abdomen and just below their stoma. This will allow the user’s ostomy pouch to be easily and comfortably positioned on the collection vessel support 4 of the collection vessel 2 for emptying the contents of the pouch or changing a pouch in a method according to the invention.

[0095] Once the user has completed the steps of changing or emptying the contents of their ostomy pouch into the waste bag within the cavity 10 and the waste bag has been removed from the cavity 10 and disposed of, the tripod 28 may be unscrewed from the collection vessel 2 and the tripod 28 collapsed for transport of storage. Alternatively, the tripod 28 attached to the collection vessel 2 may be moved into another location, for example a corner of the room, or a cupboard for convenience until it is next required.

[0096] The third key means for positioning the collection vessel 2 appropriately for a user to empty or change their ostomy pouch is by attachment to a frame 30, and in the preferred embodiment shown in Figure 12B, an adjustable frame 30 mounted to a wall that is adjustable for height and depth (from the wall). A screw attachment means 32 attached to the frame 30 is used to releasably attach the collection vessel 2 to the frame by its attachment thread 24. The height and position of the collection vessel 2 may be adjusted so that the user may walk up to the rear 16 of the collection vessel 2, and adjust the height of the collection vessel 2 so that the curved ramp edge 18 touches or is located adjacent the user’s abdomen and just below their stoma so that the user’s ostomy pouch may be easily and comfortably positioned on the collection vessel support 4 of the collection vessel 2 for emptying the contents of the pouch or changing the pouch in the preferred embodiment of the method according to the invention.

[0097] The frame 30 comprises a first frame arm 34 which is attached to a wall or another fixed surface. The first frame arm 34 comprises an elongated bar in a substantially vertical position having at least one vertical track 36 along each elongated surface. The frame 30 further comprises a second frame arm 38 comprising a substantially horizontal elongated bar comprising at least one horizontal track 40 along each elongated surface. The second frame arm 38 comprises an end 42 which engages the at least one vertical track 36 of the first frame arm 34 and enables the second frame arm 38 to move along the length of the at least one vertical track 36 of the first frame arm 34 or be releasably secured to it by a locking mechanism 44. The screw attachment means 32 which is able to releasably attach to the collection vessel 2 is located within the horizontal track 40 on an upper surface of the second frame arm 38. Therefore, the horizontal position of the collection vessel 2 when attached to the screw attachment means 32 may be adjusted by moving the screw attachment means 32 along the horizontal track 40 on the upper surface of the second frame arm 38 as benefiting for use by the user. Also, the vertical position of the collection vessel 2 when attached to the screw attachment means 32 may be adjusted by (i) unlocking the end of the second frame arm 38 from the first frame arm 34, (ii) moving the end 42 of the second frame arm 38 along the at least one vertical track 36 of the first frame arm 34 in a vertical direction, and (iii) locking the end of the second frame arm 38 to the first frame arm 34 at a height desired for use by the user. Figure 12B also shows a table 46 attached to the second frame arm 38 between the attached collection vessel 2 and the first frame arm 34 which may assist the user by providing an additional convenient surface to place things on while carrying out a method according to the invention.

[0098] Such a frame may be located, for example, within a hospital room or bathroom, or medical suite, or even the user’s own bathroom.

[0099] Figure 14 shows an example of a user performing part of a method according to the invention involving rolling their ostomy pouch to push the contents towards the open end of their ostomy pouch which is positioned above a waste bag in the cavity of a collection vessel ready to collect the contents of the pouch.

[00100] The collection vessel is manufactured in this preferred embodiment from moulded plastic, for example, injection moulding, to result in a useful and comfortable shape when worn with a belt around the waste as shown in the preferred embodiment, while also forming a sufficiently sized cavity for collection of the contents of ostomy pouches and one that is easy to clean should any contents escape the waste bag.

[00101 ] In an alternative embodiment, the removable insert may comprise a removable inner portion of the collection vessel comprising the cavity that can be separated from the collection vessel and cleaned, for example, by emptying into waste disposal and cleaned, then reattached to the collection vessel. This may be beneficial if, for example, there was a desire to reduce plastic waste and avoid using a waste bag as the removable insert each time an ostomy pouch was to be emptied.

[00102] A further preferred embodiment of a collection vessel for use in the method of the invention is shown in Figure 15A and 15B. In this embodiment, the collection vessel 50 comprises a removable support 52 comprising a ramped support portion 54. The support 52 releasably slidably engages with the collection vessel 50. [00103] Transparent walls of the collection vessel 50 show a removable flushable bag 56 (although another type of bag for disposing of waste including biological waste may be used) that lines the interior of the collection vessel for collecting contents of an ostomy pouch.

[00104] The flushable bag 56 is preferably one that breaks down approximately 30 minutes to an hour after contact with fluids comprising those in the contents of an ostomy pouch. Therefore, after collecting the contents of an ostomy pouch in the flushable bag 56, the flushable bag 56 may be placed in a toilet and flushed with the bag disintegrating and releasing the contents, for example, within the sewer system to which the toilet is attached. Figure 16 also shows the flushable bag 56 within the collection vessel 50 with the support 52 removed (Figure 16A) and the flushable bag 56 on its own (Figure 16B) with a body portion 62 and a lid portion 64. In another preferred embodiment, the flushable bag comprises machine glazed or ‘greaseproof paper. The thickness of the paper is preferably comparable to the thickness of tissues. Greaseproof paper is often also referred to as bakery paper, or parchment paper, amongst other names. Greaseproof paper is made into bags and for the present invention, preferably bags of the shape to fit the size of a collection vessel. The greaseproof paper preferably comprises a ‘wet’ glazed side that is temporarily resistant to water. The greaseproof paper is preferably machine glazed comprising a basis weight of approximately between 18 - 22 g/m². Inventor discovered that this basis weight greaseproof bag sufficiently held the contents of an emptied ostomy pouch until it could be placed in a toilet after which the bag began to degrade.

[00105] The releasably attached support 52 slides onto or off the collection vessel 50 to enable ease of access to place or remove the flushable bag 56. Flanges 58 on each side of the support 52 align with and can slidably move along a length of a matching groove 60 on each side of the collection vessel 50.

[00106] An adjustable attachment device 58 releasably connects the collection vessel 50 to the wall by suction attachment by wall clamp (though other means may also be used) for the user to position themselves in front of the collection vessel 50 to empty their ostomy pouch according to a method of the invention as described herein. A portion of alternative embodiment of the adjustable attachment device 66 is shown in Figure 17. The attachment flanges 68 align with and can slidably move along a length of a matching groove 60 on each side of the collection vessel 50. This enables releasable slidable attachment of the collection vessel 50 to the attachment device 66 so the collection vessel 50 may be removed for use elsewhere or for storage or cleaning. Adjustable attachment means 70 attach the attachment device to a frame, apparatus, tripod or another means for holding the attachment means 66 and collection vessel 50 for use in a method according to the invention.

[00107] Figure 18 shows the underside of the releasably attachable support 52 and the flanges 58, the curved ramp edge 18, and a catch 72 for releasably securing the support 52 to the collection vessel 50 to prevent movement of the top portion during use in a method according to the invention.

[00108] A further preferred embodiment of a collection vessel for use in the method to the invention is shown in Figure 19 A to C. In this embodiment, the collection vessel 80 comprises a collapsible container. The collapsible container comprises canvas in a substantially rectangular prism shape with an open top 82. The open top 82 of the collection vessel 80 is releasably attached to a slidable cassette 84 around an aperture 86 in the slidable cassette 84. Thus, as the shape of the aperture 86 is substantially the shape of the open top 82 of the collection vessel 80, the inside of the collection vessel 80 may be accessed through the aperture 84.

[00109] A benefit of using a collapsible container is for ease of storage for the user to be more easily able to store the container for travel than a fixed shape container. Thus, the container can be collapsed to make a flattened shape which fits within, for example, a carry kit bag.

[00110] The slidable cassette 84 comprises two substantially parallel sides 88 comprising a flange 90 on each of the parallel sides 88. A support 92 comprises matching grooves through which the flanges 90 can slide to releasably connect the slidable cassette 84 to the support 92.

[0011 1 ] The support 92 comprises an attachment device 94 which releasably secures the support 92 to the user. In this preferred embodiment, this attachment device 94 is a strap with an adjustable length which the user can releasably attach around their waist by a releasable clip 96. Length adjusters 98 are located adjacent the attachment of attachment device 94 to support 92.

[00112] The support 92 comprises a ramped portion 100 having a curved ramp edge 102 against which the user’s abdomen under the ostomy pouch the support 92 is positioned.

[00113] A drop lock 104 in the centre of the support 92 enables releasable attachment of the support 92 to the slidable cassette 84 to maintain it in place during use by hooking onto the slidable cassette 84. The drop lock 104 can be raised from its ‘lock position’ being flush with the level of the ramped portion, to its ‘unlock position’ to enable the slidable cassette 84 to be slidably separated from the support 92.

[00114] A kit is provided as shown in Figure 19B with the parts including support 92 attached to the attachment device 94, slidable cassette 84, collection vessel 80 which can be assembled by the user to conduct the method of the invention. In addition to bags for storing pre-used and used flushable bags, tissues and/or wipes and other parts of the equipment for ease of mobility for the user.

[00115] Trial Feedback

[00116] Trials were conducted with ostomates under various conditions, and their comments were provided on their experiences in using the method of the invention using provided apparatus as described herein.

[00117] Adam (surnames not supplied) trialled the method and apparatus during a road trip from Darwin to Perth, Australia (approximately 4000 km, 2,500 miles). Adam reported that on the various stops while travelling, he had been able to use the apparatus with a benefit that he was able to avoid the (often less than clean) toilets available, and that it “worked perfectly”.

[00118] Arno trialled the first preferred embodiment attached by a belt (strap) and commented that it “works great” and he uses it most days in the evening finding it “so much easier standing up” than how he previously emptied his ostomy pouch. [00119] Murray commented on it being “highly beneficial for emptying purposes”. Most benefit in “more thoroughly emptying” the pouch so it lasts longer before having to re-empty. Also “benefit to skin with less pulling” than usual methods. Liked the mobile kit bag for use when not at home. [00120] These trials were important to receive feedback from ostomates showing that: (i) the method of the invention and supporting apparatus to perform the method made the process of cleaning the pouches easier for them, (ii) there was less pressure and therefore reduced potential damage to the skin around the ostomy, and (iii) allowed them to be more mobile with a kit comprising the apparatus providing them with more confidence away from home.

Claims

32 The Claims Defining the Invention are as Follows

1 . A method for emptying contents from an emptiable ostomy pouch while attached to the skin of a user surrounding a stoma, the method comprising the steps: placing an ostomy pouch on to a support, the pouch comprising a top surface and a bottom surface and the bottom surface contacting the support, and wherein the ostomy pouch at a first end is attached to the skin of a user surrounding a stoma and at a second end has been opened for emptying the contents of the pouch; exerting a first directional force at a contact position on the top surface of the pouch at a first contact location using an emptying means to force the top and bottom surfaces of the pouch together against the support; exerting a second directional force by moving the emptying means across the top surface of the pouch from the first contact location towards the open second end while maintaining the first directional force to force the top and bottom surfaces of the pouch together between the emptying means and support; and forcing contents of the pouch out of the open second end.

2. A method according to claim 1 , wherein the support comprises a ramped portion comprising a linear and/or curved gradient.

3. A method according to claim 2, wherein the ramped portion comprises a curved edge which is placed against the skin of the user immediately below the attached first end of the pouch, and the angle of the ramped portion comprises a declining gradient from the curved edge at the skin of the user.

4. A method according to any one of claims 1 to 3, wherein the support forms part of, is attached to, or is releasably attached to a collection vessel. 33

5. A method according to claim 4, wherein the contents of the pouch forced out of the open second end are collected in a cavity in the collection vessel.

6. A method according to claim 5, comprising the additional step of emptying the cavity of the collected contents of the pouch.

7. A method according to claim 5 or claim 6, wherein the cavity comprises a removable insert into which the contents of the pouch is collected.

8. A method according to claim 7, wherein the removable insert comprises a flushable insert or a disposable or flushable bag.

9. A method according to claim 8, wherein the flushable insert or flushable bag can disintegrate upon sustained contact with liquid and moisture.

10. A method according to any one of the preceding claims, wherein the emptying means comprises a roller.

1 1. A method according to claim 10, wherein the roller is attached, is releasably attached, or comprises part of, a collection vessel support of the collection vessel.

12. A method according to claim 10, wherein the roller is separate to the collection vessel.

13. A method according to any one of claims 3 to 12, wherein the bottom surface of the pouch contacts at least a portion of a declining gradient of the ramped portion and gravity assists the second directional force in forcing contents of the pouch out of the open second end.

14. A method according to any one claims 4 to 13, wherein the collection vessel comprises an attachment means for releasably attaching the collection vessel to the user.

15. A method according to claim 14, wherein the attachment means comprises a strap for releasably securing the collection vessel to the user. A method according to claim 15, wherein the strap comprises a belt of adjustable length. A method according to any one of claims 4 to 16, wherein the bottom surface of the collection vessel comprises an attachment means for releasably attaching the collection vessel to a frame. A method according to claim 17, wherein the frame comprises a tripod. A method according to claim 17, wherein the frame is attached to a wall or other surface. A method according to claim 17, wherein the frame is adjustable to adjust the position and/or height of the collection vessel and support relative to a user and their ostomy pouch. A support for use in a method according to any one of claims 1 to 20. A collection vessel for use in a method according to any one of claims 4 to 20. Use of a support for performing a method according to any one of claims 1 to 20. Use of a collection vessel for performing a method according to any one of claims 4 to 20. A kit for use in the method of any one of claims 1 to 20, the kit comprising a roller, collection vessel and support and at least one flushable insert or flushable bag. A process for the manufacture of a support for use in a method according to any one of claims 1 to 20. A process for the manufacture of a collection vessel for use in a method according to any one of claims 4 to 20.