EP-4736822-A2 - OSTOMY APPLIANCE

EP4736822A2EP 4736822 A2EP4736822 A2EP 4736822A2EP-4736822-A2

Abstract

The ostomy appliance (10) of the present disclosure comprises at least one appliance wall (11) of flexible sheet material forming a cavity (13) for containing a stomal output comprising stomal gas and stomal liquid and/or solids. The at least one appliance wall (11) comprises a stomal inlet (14) for receiving the stomal output and a gas vent (15) for allowing the stomal gas to migrate out of the cavity (13). A shield wall of flexible sheet material extends between the inner and outer walls across the stomal inlet. The shield wall comprises a spacer arrangement for at least partially separating the shield wall from the inner and/or outer wall for forming a fluid path therebetween. The spacer arrangement comprising at least one undulation of the flexible sheet material of the shield wall.

Inventors

HOGGARTH, MARCUS
POYNTZ, OLIVER

Assignees

ConvaTec Limited

Dates

Publication Date: 20260506
Application Date: 20210414

Claims (15)

An ostomy appliance comprising: inner and outer walls of flexible sheet material forming a cavity for containing a stomal output, the inner wall comprising a stomal inlet for receiving the stomal output; and a shield wall of flexible sheet material extending between the inner and outer walls across the stomal inlet and comprising a spacer arrangement for at least partially separating the shield wall from the inner and/or outer wall for forming a fluid path therebetween, the spacer arrangement comprising at least one undulation of the flexible sheet material of the shield wall.
The ostomy appliance of claim 1 wherein the flexible sheet material extends across a shield wall area and the shield wall overlaps the inner and/or outer wall across an overlap area of the inner and/or outer wall, wherein the shield wall area is greater than the overlap area such that the at least one undulation is formed by a region of excess flexible sheet material of the shield wall relative to the overlapping region of the inner and/or outer wall.
The ostomy appliance of claim 2 wherein the spacer arrangement is formed from only the flexible sheet material.
The ostomy appliance of any one of the preceding claims wherein the thickness of the flexible sheet material of the shield wall is constant across the at least one undulation.
The ostomy appliance of any one of the preceding claims wherein the shield wall extends from a top of the ostomy appliance between edges of the ostomy appliance.
The ostomy appliance of any one of the preceding claims wherein the shield wall extends to a lower edge separated from a cavity lower end such that stomal output can pass between the lower edge and cavity lower end.
The ostomy appliance of any one of the preceding claims wherein the shield wall comprises a substantially impermeable region opposite and entirely overlapping the stomal inlet.
The ostomy appliance of any one of the preceding claims wherein the shield wall comprises at least one shield wall aperture therethrough, the at least one shield wall aperture being located adjacent to and not overlapping the stomal inlet.
The ostomy appliance of any one of the preceding claims wherein the outer wall comprises a gas vent for allowing stomal gas of the stomal output to migrate out of the cavity and wherein the fluid path allows stomal gas to reach the gas vent.
The ostomy appliance of claim 9 further comprising a filter arrangement mounted over the gas vent for allowing stomal gas to migrate from the cavity, through the filter arrangement and out of the ostomy appliance via the gas vent.
The ostomy appliance of claim 10 wherein the shield wall is attached and located between the filter arrangement and the inner wall.
The ostomy appliance of claim 10 or claim 11 wherein the filter arrangement comprises at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, wherein the at least one filter channel inlet is located in the cavity for receiving the stomal output from the cavity and the filter channel outlet is mounted in communication with the gas vent for allowing stomal gas to migrate out of the at least one filter channel to the gas vent, and wherein the at least one undulation forms a fluid path extending adjacent to the shield wall to the at least one filter channel inlet.
A method of manufacturing an ostomy appliance comprising: attaching inner and outer walls of flexible sheet material together to form a cavity for containing a stomal output, the inner wall comprising a stomal inlet for receiving the stomal output; attaching a shield wall of flexible sheet material to the inner and/or outer wall such that the shield wall extends across the stomal inlet; and forming at least one undulation in the flexible sheet material of the shield wall to form a spacer arrangement for at least partially separating the shield wall from the inner and/or outer wall for forming a fluid path therebetween.
The method of claim 13 wherein the flexible sheet material of the shield wall extends across a substantially flat plane prior to forming the at least one undulation and forming the at least one undulation comprises bringing at least part of the flexible sheet material of the shield wall out of the flat plane.
The method of claim 13 or 14 comprising forming the at least one undulation during the attaching of the shield wall to the inner and/or outer wall.

Description

Technical Field The present disclosure relates to an ostomy appliance for managing effluent from a stoma and particularly to an ostomy appliance comprising a filter arrangement. The present disclosure further provides a method of manufacturing an ostomy appliance. Background of the disclosure There are many forms of ostomy appliance which try to provide a secure, comfortable fit for ostomates. However, stomal output gas may accumulate in the ostomy appliance, resulting in the ostomy appliance expanding and increasing the likelihood of the ostomy appliance moving from its original position during use. In addition to forming a visible bulge under the ostomate's clothing, any movement of the ostomy appliance may result in leaking or the ostomy appliance falling off the ostomate. Therefore, the ostomy appliance may include an outlet for the stomal output gas to escape from the ostomy appliance. An odour absorbing gas filter may be employed at the outlet. However, the outlet and/or filter may become blocked and thus expansion of the ostomy appliance may still occur. US-B-8298201 discloses a filter for an ostomy appliance comprising a pathway for leading gases to a vent in an ostomy bag and a protective element contained in said pathway to prevent solid or semi-liquid waste from blocking the pathway. A channel formed by a liquid impermeable layer defines the pathway and contains a protective element of an open celled compressible material having a memory and a pore size of at least 60 PPI. The protective element extends in the same direction as the gas flow within the channel. The channel has an opening providing access to the pathway from the interior of the bag and the pathway has another opening being connected to a vent in the ostomy bag, optionally via a deodorizing filter. US-A-2003/0014023 discloses a body waste collector. US-B-5250042 discloses an ostomy bag with a filter combination. There remains a need for ostomy appliances with enhanced usability for ostomates, particularly in the areas of improved stomal output gas venting and reduced ostomy appliance expansion due to stomal output gas. Summary of the disclosure In this specification, the term "stomal output" refers to any gases or fluids or solids produced by an ostomate that may be secreted from the stoma or that exit the stoma. The stomal output may comprise stomal gas, stomal liquid and stomal solids. In this specification, the term "stoma" refers to an opening in the body. Generally the stoma is a surgical opening in the torso of the body. In some instances, the term "stoma" also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine. In this specification, the term "ostomate" refers to a subject that may have use of the ostomy appliance disclosed herein. While ostomate usually refers to a subject with a surgical opening, as used herein, "ostomate" may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means. The term "user" may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity. In this specification, the ostomy appliances disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, an ureterostomy, or a vesicostomy. The ostomy appliances disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a fecal management system. In this specification locations and orientations of features may be described with reference to the ostomy appliance being "in use", "orientated as it would be in use" or similar. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to a body of an ostomate with the ostomate in a standing position, irrespective of whether the ostomy appliance is currently performing such a use or the actual position of the ostomate. The terms "upper", "lower", "top", "bottom" and related terms refer to the relative position of a part or portion of the ostomy appliance when orientated as it would be in use. For example, an apex of the ostomy appliance may be referred to as an "upper" apex in use of the ostomy appliance. In such an example, said apex will be intended to be the uppermost apex (in the vertical direction) of the ostomy appliance when attached to the body of a standing ostomate. However the reader skilled in the art will appreciate that before attachment to the ostomate said apex may not always be the uppermost apex and in addition whe