IES20140047A2 - Apparatus to protect abdominal stoma and prevent ostomy pouch from leaking - Google Patents

Abstract

A device to protect abdominal stoma from pressure from clothing and impact, and to prevent an ostomy pouch from leaking, without the use of a fixed belt, is presented. Leakage in existing products occurs due to: the movement of the fixed belt, the gathering of faecal matter around the stoma, the wearing of a waistband below the stoma, and finally impact and pressure; leading to the adhesive seal coming away from the abdomen (blow-out). There are two separate components: a baseplate, and a cover which attaches to the baseplate. The baseplate is designed to exert a gentle pressure on the adhesive flange of an ostomy pouch. The rigid cover is designed to protect the stoma from pressure from clothing waistbands. The back of the cover has a "keyhole" shaped plate, adding to the rigidity and preventing faecal matter from congregating around the stoma by channeling it into the ostomy pouch.

Description

Apparatus to protect abdominal stoma and prevent ostomy pouch from leaking.

FIELD OF INVENTION The present invention relates to abdominal stomas. In particular the invention relates to: 1. A device that prevents leaks from the adhesive flange of an ostomy pouch; which is the device used to collect the faecal matter that emanates from an abdominal stoma. 2. A device for the protection of abdominal stomas from pressure and impact. 3. A device that prevents faecal matter from congregating around an abdominal stoma. 4. A device that allows ostomates to wear a wider variety of clothing, especially clothing that contains a waistband.

BACKGROUND An abdominal stoma is the result of having had ileostomy or colostomy surgery. An ileostomy is a surgical opening constructed by bringing the end of the small intestine through the abdomen following the removal of the large intestine. A colostomy is a surgical opening constructed by bringing the large intestine through the abdomen following the removal of part of the large intestine. The point of exiting the abdomen is what is known as the stoma. An ostomy pouching system (also colloquially called a bag) is a medical device prosthetic that provides a means for the collection of the faecal matter emanating from the body.

An abdominal stoma can extend up to 3/4cm from the skin, and while it is not normally painful it can be uncomfortable if clothing is continually pressing on it. This is a particular problem with garments that contain a waistband, e.g., trousers and skirts; because the stoma is usually located in the area where the waistband normally sits. It is also vitally important that the faecal matter is not restricted in any way from entering into the ostomy pouch, so wearing the waistband under the stoma can be problematic. The ostomy pouch is attached to the skin by means of an adhesive flange and is prone to come away from the skin, particularly if there are any restrictions. Breaching of the adhesive flange leads to leakage of faecal matter onto clothing and odour issues. This is colloquially known as a “blow out” and is a very common occurrence.

There are many products on the market that purport to help protect a stoma. All of the products available are attached to a fixed belt and this has several disadvantages. Firstly the belt is uncomfortable to wear, and secondly the belt is prone to movement, unless it is worn very 8865^9 2. tightly. Movement of the belt can move the device that protects the stoma, and if it moves any considerable distance, it can dislodge the ostomy pouch, breaking the adhesive seal and leading to a blow-out. None of the available products on the market address the problem of preventing the adhesive flange coming away from the abdomen and causing leaks.

The invention is designed to address both of these problems: (i) the prevention of leaks and (ii) the protection of the stoma, without the use of a fixed belt. Hence the apparatus has two separate components; a Baseplate and a Cover. The Baseplate, worn independently of the cover, prevents the adhesive flange of the ostomy pouch from detaching from the skin, therefore preventing leaks in this area. The Baseplate does not require a fixed belt to keep it in position; it uses the construction of the ostomy pouch and the wearer’s underwear or elasticised waistband to keep it in place. When the Cover is added to the Baseplate the stoma is protected from any impact it may sustain, or, from pressure of any clothing on it. It is also designed to prevent faecal matter from congregating around the stoma and to channel it into the ostomy pouch, therefore preventing the phenomenon known as “pancaking”.

STATEMENT OF INVENTION The apparatus is comprised of two separate components. The first component is a Baseplate; the second component is a Cover, which attaches to the Baseplate.

The first component, the Baseplate can be worn independently of the second component, the Cover.

The Baseplate is designed to exert a gentle pressure on the adhesive flange of an ostomy pouch. The adhesive flange is the method by which the ostomy pouch is attached to the abdomen of the wearer. During the normal course of day-to-day living the wearer walks, sits, bends, etc, which can reduce or loosen the adhesion of the adhesive flange. The Baseplate is designed to prevent this problem under normal circumstances.

It is also designed to be comfortable and lightweight to wear. It does not require a fixed belt to keep it in position but uses the construction of the ostomy pouch and the wearer’s underwear or elasticised waistband to keep it in place. This makes it easier for the wearer to use and the ostomy pouch can be emptied without any difficulty. 3.

The Baseplate can be worn independently of the Cover, which means it can be worn under dresses, tops, etc., without adding any bulk to the ostomy pouch. This means it can be worn by females in a wider variety of circumstances while also achieving the protection from leaks.

The Baseplate is constructed using different grades of plastics configured to maintain the gentle pressure around the adhesive flange area of the ostomy pouch and also to distribute the pressure around the edges of the Baseplate to ensure it maintains its effectiveness. It is also covered, on one side, using a skin-friendly material to ensure the highest skincare and hygiene standards. The other side is covered with Velcro so the Cover can be attached to it.

The Cover is designed primarily to protect the Stoma. Because of the location of the Stoma on the person’s abdomen it is often impacted by the wearers clothing, particularly clothing that contains a waistband, like a trouser or skirt.

It is designed in a slightly curved fashion to fit around the abdomen. Its outer cover has an elevated channel that allows space for the Stoma to operate effectively, allowing the faecal matter to enter the ostomy pouch without obstruction. It has Velcro strips at each side to allow it to be attached to the Baseplate.

The back of the Cover has a “keyhole” shaped plate extending across from side to side. The “keyhole” shape fits over the Stoma and is designed to prevent the faecal matter from congregating around the Stoma. This is known colloquially as “pancaking” (or “pattycaking” as it is called in the US). It occurs when the faecal matter sits on or around the stoma and fails to drop into the ostomy pouch. As more faecal matter comes out there is nowhere for it to go so it often pushes its way under the adhesive flange and causes a leak. This can also lead to problems with sore skin if it is constantly exposed to the faecal matter. The keyhole plate channels the faecal matter directly downwards; minimising the presence of faecal matter near the adhesive flange and hence preventing leakage and blowout.

The “keyhole” shaped plate also makes the Cover rigid. This prevents the open end at the bottom of the Cover from collapsing and restricting the flow of the faecal matter into the ostomy pouch when pressure is exerted on it. 4.

It is also designed to allow the wearer to wear a variety of fashion garments that sit at different levels on the person’s waist. For example, jeans are often cut with a lower “rise” than a classic trouser, which means it sits lower on the person’s waist. Under normal circumstances, jeans would sit below the Stoma and therefore on the ostomy pouch which would restrict the faecal matter from entering the ostomy pouch. Because of the rigidity of the Cover a garment with a waistband can be worn at any position on the Cover. This would cover a large variety of fashion garments and allow the wearer to dress in the fashion of the day.

BRIEF DESCRIPTION OF DRAWINGS.

The invention will be more clearly understood from the following description of an embodiment thereof, given by way of an example only, with reference to the accompanying drawings, in which: Figure 1: shows Baseplate (1) with “shaped form” strengthener (3) in position.

Figure 2: shows cross section view of “shaped form” (3) showing tapering shape.

Figure 3: shows “shaped form” (3) with a “T” shaped ridge (4) added to strengthen it.

Figure 4: shows cross section view of centre section of shaped form (3) showing “T” shaped ridge (4).

Figure 5: shows view of Baseplate (1) sitting on abdomen (5) on top of adhesive flange (6). Item (8) shows Baseplate (1) bent over adhesive flange (6) on to abdomen (5).

Figure 6: shows drawing of topside of Cover (9) showing elevated section (10).

Figure 7: shows drawing of underside of cover (9) with “keyhole” shaped plate (11) and Velcro strips (12) added.

Figure 8: shows complete apparatus, including ostomy pouch (13).

DETAILED DESCRIPTION OF DRAWINGS.

Referring now to the drawings and in particular to the Baseplate: Figure 1: there is illustrated the Baseplate (1) which has a hole cut from the centre (2) to allow the Baseplate to be fitted between the adhesive flange (6) and the body of the ostomy pouch (13). The Baseplate (1) is made from a flexible plastic material that bends with body movements and is therefore comfortable to wear.

Figure 1: also shows a “shaped form” (3) permanently connected to the Baseplate (1). The “shaped form” (3) being a circular section with spines protruding each side from the top, bottom, and centre of the circle section. The “shaped form” (3) is made from a semi-ridged plastic and is . designed to keep the centre of the Baseplate ridged while allowing the outer edges to remain flexible.

Figure 2: shows a cross section view of the “shaped form” (3) which is at its full height at the centre circular section and tapers off at the ends of each spine to allow the outer edge flexibility.

Figure 3: illustrates the “shaped form” (3) showing the top section with a “T” shaped ridge (4) added to give strength to the “shaped form” (3) to make it semi rigid. The “T” shaped ridge (4) has been added to keep the depth of the “shaped form” to a minimum while maintaining the desired rigidity.

Figure 4: shows a cross section view of the “shaped form” (3) showing the “T” shaped ridge (4). Figure 5: shows a cross section view of the Baseplate (1) in normal position sitting on the abdomen (5) and on top of the adhesive flange of the ostomy pouch (6) and sitting over the stoma (7). Item (8) shows Baseplate (1) bent over abdomen (5) and adhesive flange (6) applying pressure to adhesive flange (6) to prevent adhesive seal from breaking.

Referring now to the drawings and in particular to the Cover: Figure 6: is the topside of the Cover (9). It is made from a semi-rigid plastic and is formed in a slightly curved shape to sit on the abdomen. It is also formed with an elevated section (10) extending nearly the full width of the Cover. This is designed to allow the stoma to operate effectively and to allow the faecal matter to flow into the ostomy pouch without hindrance.

Figure 7: is the underside of the cover (9) showing the “keyhole” shaped plate. This is made from a ridged plastic and is shaped to fit around the top and sides of the stoma. The ends are curved out to the sides and finish at the bottom of the Cover. This is designed prevent the faecal matter from congregating around the stoma. It is also constructed to give rigidity to the Cover so the bottom section does not collapse when pressure is applied to it. Item (12) shows two Velcro strips added to allow the Cover to be attached to the Baseplate.

Figure 8: shows drawing of the whole apparatus, including ostomy pouch (13).

Claims (5)

1. An apparatus for protection of a stoma and the prevention of leaks from the adhesive flange section of an ostomy pouch comprising a baseplate that is constructed from a flexible plastic material and a cover with an elevated channel (10) to allow faecal matter to enter the ostomy pouch without obstruction, wherein the baseplate can be worn independently of the cover because it performs the function of preventing leaks without the need for a fixed belt to keep it in place but uses the construction of the ostomy pouch and the wearer’s underwear or an elasticised waistband to keep it in position.

2. An apparatus as claimed in claim 1 wherein the baseplate comprises a shaped-form of circular section made from semi-rigid plastic with spines radiating from the circular section, and wherein the shaped form is designed to keep the centre of the baseplate rigid while allowing the outer edges to remain flexible.

3. An apparatus as claimed in any previous claim wherein the cover, which attaches to the baseplate, is made from a semi-rigid lightweight plastic and is formed in a curved shape to sit on the abdomen and protect the stoma from pressure and impact.

4. An apparatus as claimed in any previous claim wherein the underside of the cover comprises a keyhole shaped plate (11) to prevent faecal matter from congregating round the stoma and therefore pushing out under the adhesive flange causing leaks.

5. An apparatus substantially as described herein, with reference to, and as illustrated in, the accompanying drawings.