WO2018055420A1

WO2018055420A1 - Stoma device

Info

Publication number: WO2018055420A1
Application number: PCT/GR2017/000056
Authority: WO
Inventors: Theodore VLACHOPOULOS
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-09-26
Filing date: 2017-09-21
Publication date: 2018-03-29
Anticipated expiration: 2019-03-26
Also published as: GR20160100486A

Abstract

The new stoma device of one (1) and two (2) pieces will be made of silicone, which is hypoallergenic and gives comfort in applying the system to the body. When using the system, no sounds of friction with the clothes are reproduced, and the internal embossed design of the colostomy and ileostomy pouches will dampen the produced sounds. Finally, the urostomy pouch will contain a sophisticated drain valve, which will allow it to seal hermetically. The opening nozzle will have a lid to maximize leakage prevention.

Description

STOMA DEVICE

The invention refers to a stoma (ostomy) device, which is applied post-operatively to patients who have undergone stoma. The present device comprises either of a one-piece system, specifically a self- adhesive pouch with an integrated hydrocoHoid adhesion surface or a two-piece system, specifically a ski barrier consisting of the adhesive surface of a hydrocolloid mixture with a seal attached to the appropriate pouch.

Stoma devices are widely available in the market, are made of hard or soft plastic material for the skin barriers and pouches, often lined with a fabric cover. This plastic or nylon material is unsuitable for the intended use as it is rigid and produces sounds when compressed or rubbed upon contact with the clothing or body of the patient.

More specifically:

- In the two-piece system, the plastic piece with the adhesive surface which forms the skin barrier adjusted onto the patient's body is provided with a single gasket adapted to be hermetically sealed onto the respective pouch used for the secretions of the body.

-In the one-piece system, the pouch used for the secretions has an appropriately shaped unified surface with a specially formed hydrocoHoid material at the end of the stoma, in order to adapt by sticking to the patient's body.

Both of the above systems have serious drawbacks which make it difficult for them to function properly in relation to the normal life of the patient. In particular, the patient feels discomfort due to the rigid material of the body fitting piece while the material the pouch is made of additionally makes disturbing sounds during the patient's movement and due to the friction caused when the device contacts the garments, revealing the presence of a stoma system. In addition, undesirable sounds are also caused by the voluntary or involuntary functioning of body exudates which again reveal the existence of a stoma resulting in the patient's embarrassment and social dysfunction.

In the same context, the above pouches, the use of which relates to treatment of intestinal problems with the help of a stoma, are provided with a filter at the top for the emission of the gases produced so that the pouch does not swell. Similarly, for pouches used for urine diversion for urinary tract disorders, sounds are similarly heard when rubbed with clothing. In addition, the urine drain valve at the bottom consists either of a limited-flow plastic tap or a silicone nozzle with a cap.

-The padding of both the skin barrier and the self-adhesive pouches usually has a design of concentric circles or spirals with an initial size of fifteen millimeters (15mm) to one hundred and twenty millimeters (120mm). In some cases, pre-cut circular diameters of predetermined cross-sections, which can not cover the range of the required dimensions and shapes, are also available. For these purposes, surface of adhesion and to cut it with scissor according to the figure, resulting in slight variations and consequent problems of the application of the pouch on the patient's body.

All of the above-described problems have led to the need to create a staple arrangement that will cope with and overcome successfully by providing a system that will be applied with ease and accuracy to the patient's body while at the same time eliminating undesirable sounds and providing comfort to their use.

BRIEF DESCRIPTION OF THE INVENTION

According to the present invention, the stoma device system we devised uses, both for the skin barrier of the pouch that contacts the body and the pouch, silicone, silicone materials or other materials which have similar properties with silicone used for medicine and i general the manufacturing of industrial molded plastic. The advantages of this specific choice have been identified and described in detail below:

-The silicone used in medical science is hypoallergenic and allows the items of the device to minimize the sounds produced by friction with the garments while giving the user the feeling of comfort due to its flexibility and soft texture of the material when in contact with the body.

-Furthermore, the design of the inner surface of the colostomy and ileostomy pouches, made of silicone or other materials , is embossed to prevent transmission and help absorbance of the generated sounds; in addition the silicone material offers the desired flexibility and consequently the restoration of the material to its original form.

- In the free gap created at the periphery of the gasket, between a skin barrier piece and a free part of it, a magnetic strip is placed perimetrically and either around its periphery or at separated equal parts, which on the one hand helps to hold it in place near the skin barrier piece of the pouch that 'hangs' due to the weight of the secretions it receives, and on the other hand the version of the discontinuous magnetic tape ensures the flexibility of the skin barrier piece and thus better fits on the body of the patient.

- Finally, the drain valve of the urine diverting pouch is designed according to the spherical tap mechanism for better operation and leakage safety. DETAILED DESCRIPTION OF THE INVENTION

According to a preferred application of the present invention, there is a silicone or of other similar material piece, with a suitable shape, such as round, rectangular, oval or other, with a hole at its center corresponding to the existing stoma; and the rear surface thereof has a hydrocolloid substance to adapt to the patient's body. On the other surface there is an assembled gasket on which the suitable silicone or other material pouch is secured to receive the secretions. silicone or other equivalent material, which has in its center a hole corresponding to the respective stoma. This single system has a hydrocolloid surface for adhering to the body, the other surface having already affixed the appropriate pouch, which pouch is constituted by a silicone material according to the present invention which is either uncovered or covered by a special fabric. The hydrocolloid-coatcd surface preferably has arch-like corrugations which allow for better adhesion and contact with the patient's body due to the vacuum conditions created on wet skin and ensure excellent contact while the corrugated configuration allows deformation of the material and ensures adaptation to the need to deform the skin barrier piece into the shape of the stoma thereby rendering the skin barrier piece flexible and therefore adaptable in shape.

In both cases of either two single pieces or a single system, both the bore-hole and the pouch consist of a silicone material which is deemed suitable and achieves the purpose of the invention to prevent unwanted sounds, flexibility and soft texture in contact with the patient's body and clothing. The silicone pouch of the present invention on its inner surface is not smooth - as in the prior art, but it has corrugated ribbons or other forms of irregularities, that is, embossed, in order to thereby break down and reduce undesirable - secreted - sounds.

In the preferred embodiment of the present invention, the urostomy pouch has at its lower end a tap designed according to the spherical tap principles for better water tightness and control of the discharge of its liquid content. DETAILED DESCRIPTION OF THE INVENTION WITH REFERENCE TO THE DRAWINGS Drawing 1

Figure A shows the front view of the skin barrier which will be adapted on the patient body, the inside of which shows the precut hole (Al), the perimeter of which contacts and encloses the stoma, on the other hand the surrounding gasket (A2). Figure B is the rear view of the skin barrier, showing the hydrocolloid surface (Bl) covered with a protective tape. Figure C is depicted in the rear view of the skin barrier, showing the hydrocolloid portion (CI) with the corrugated surface for better adhesion and ease of flexibility without the protective tape ready to use and placement in the patient's body.

Drawing 2

Drawing 2 shows the skin barrier of Drawing 1 in side view, in particular: Referring to Figure A, the side view of the skin barrier with the gasket in a deployed position is shown, in particular, the position of the gasket is shown when it has been pulled by the patient to provide the required space for the user's handle and placement or removal of the pouch. In the same figure, under B, the separated magnetic strip which magnetic tape allows the gasket to be held in the retracted position during use. In the same figure under C, the fully collapsed position of the gasket in the skin barrier is shown when there is no pulling force. Drawing 3

Drawing 3 shows under A, the colostomy pouch held in place near the skin barrier due to the existence of a magnetic strip while, under B colostomy pouch in a drop position at the top weight of body exudates without the presence of a magnetic tape.

Drawing 4 In drawing 4, under A, the front face of the skin barrier with the precut hole and the surrounding gasket embedded in the deformatio position is shown due to the flexibility of the silicone material and the corrugated grooves on the surface of the hydrocolloid, thus allowing for optimal adaptation to shape of the stoma and the patient's body. In the same drawing, under B, there is shown the rear face of the skin barrier showing the hydrocolloid corrugations and the new shape of the hole and consequently of the stoma due to deformation of the flexible silicone or other corresponding material properties.

Drawing 5

Drawing 5 shows the colostomy or ileostomy pouch to be attached to the skin barrier or already attached. In drawing 5, under A, the inner surface of the pouch is shown on the side of the bore (Al) and fixed to the skin barrier A of drawing 1. In the same drawing B is the opposite inner surface of the pouch, which carries the inventive ribbons (Bl) to break down and neutralize the undesirable sounds caused by entering the patient's body exudates therein. Drawing 5, under C, shows the inventive slots in cross-section of the pouch (A) prior to any deformation of the pouch, i.e. in the non-use state i.e. before the exudation is received. In the same drawing under D, the pouch is shown in section, showing the inventive ribbons after use, i.e. in the state of expansion of the pouch during use.

Drawing 6

Drawing 6 shows the cock provided in the urostomy pouch, in particular under A and C the shells of the urostomy pouch are shown, i.e., the outer surface and the inner ball valve thereof under B.

Claims

1. A stoma device of one or two pieces with a pouch integral with the skin barrier or separately mounted by means of a gasket in the skin barrier, wherein the whole device, Le. skin barrier and pouch, is formed from silicone or other similar material properties.

2. The stoma device of claim 1, wherein the pouch, either integral with the skin barrier or separate and secured by a gasket, is constituted by silicone material or other similar properties and carries on its inner surface ribbons rendering it non-homogeneous and embossed to be broken of the unwanted sounds produced by the secretions it receives when rubbing it with the body and the clothes of the patient.

3. The stoma device of claim 2 wherein the skin barrier disposed in the patient's body will have an inner surface with a hydrocolloid mixture which will be provided with arc like or irregular corrugations for the purpose of better and more flexible adhesion to the body.

4. The stoma device of the preceding claims, the skin barrier of which has on its outer surface a silicone-containing gasket to which the silicone material pouch is attached.

5. The stoma device of the preceding claim wherein the silicone-containing gasket has on its outer perimeter, either along its entire length or in its separated equal portions, a magnetic strip for retaining the gasket and thereby the adjustable pouch in a retracted position so as not to hang under the weight of secretions.

6. The stoma device of the preceding claims wherein the skin barrier adhered to the patient's body carries graduated concentric circles or deficiencies from a plurality of precut circular diameters of particular cross-sections for its corresponding cutting to the needs of the individual patient's cross section.

7. The stoma device according to the preceding claims, wherein the urostomy pouch has at its lower end a spherical tap to achieve leakage and control of the discharge of its liquid content.