EP-3801411-B1 - OSTOMY BAG AND ITS METHOD OF MANUFACTURE

Inventors

• KELLEHER, KEVIN
• SPAIN, Eoghan

Dates

Publication Date

20260513

Application Date

20190603

Claims (10)

1. An ostomy bag (1) for collecting output from a stoma comprising: - a bag having at least one opening (6) for accepting ostomy output; characterised in that it further comprises: - a spout (10) positioned at least partially around the edge of the at least one opening; wherein the spout extends away from the at least one opening and radially outwardly from the at least one opening, into the interior of the bag; wherein the spout is fixedly attached to the bag.
2. The ostomy bag of Claim 1, wherein the spout extends outwardly from the interior of the bag such that an outer end of the spout rests against or near to a patient's skin when in use.
3. The ostomy bag of any one of Claim 1 or Claim 2, wherein the spout is configured to direct ostomy output away from a patient's skin and into the ostomy bag; preferably wherein the spout is angled to optimise collection of ostomy output and delivery of ostomy output into the ostomy bag.
4. The ostomy bag of any one of Claims 1 to 3, wherein the spout extends a perpendicular distance from the at least one opening into the bag by between 1 cm and 5 cm.
5. The ostomy bag of any one of Claims 1 to 4, wherein the spout is fixedly attached to the bag via attachment to a plate permanently fixed to an exterior of the bag.
6. The ostomy bag of Claim 5, wherein the permanent fixing is at least one of plastic welding, melting, screws, rivets, pins.
7. The ostomy bag of Claim 5 or Claim 6, wherein the plate is configured for attachment to a seal for fixing the ostomy bag to the patient's skin; preferably wherein the plate comprises the seal; more preferably wherein the plate comprises a first face and a second face and wherein the seal attaches to the first face of the plate and the bag is attached to the second face of the plate.
8. The ostomy bag of any one of Claims 1 to 7, wherein the spout comprises at least one flexible arm that extends around the at least one opening; preferably wherein the spout comprises two flexible arms that extend around the at least one opening.
9. The ostomy bag of any one of Claims 1 to 8, wherein the bag has generally circular concentric markings around the at least one opening to provide the user with a guide for adjusting the size of the at least one opening; preferably wherein the generally circular markings share an edge with the at least one opening adjacent with the spout.
10. A method for manufacturing an ostomy bag (1) of any one of Claims 1 to 9, comprising the steps of: - providing a rear impermeable layer (2,4) having at least one opening (6); - fixedly attaching a spout (10) to a section of the edge of the at least one opening such that the spout extends away from the at least one opening and radially outwardly from the at least one opening; - providing a front impermeable layer; - sealing the front impermeable layer to the rear impermeable layer around at least a substantial portion of the outer contacting edges to form the ostomy bag such that the spout extends predominantly into the interior of the ostomy bag formed; preferably wherein the spout is fixedly attached to the bag via attachment to a plate positioned on an exterior of the bag.

Description

FIELD The invention relates to the field of ostomy bags or pouches. BACKGROUND OF THE INVENTION An ostomy is a surgically-created opening in the body to allow for discharge of bodily fluids, typically waste products. An ostomy is associated with a stoma, an externalising of a body cavity such as the intestine, ileum or ureter; the ostomy providing an alternative fluid outlet for that cavity via the stoma. Use of an ostomy typically follows surgery or disease that has disrupted the normal path of bodily fluids or waste through and/or from that body cavity. The most common types of ostomy are: a colostomy, where the colon is diverted to an ostomy in the abdominal wall, typically following surgery to remove a lower part of the colon; ileostomy where a similar procedure is applied to the small intestine (the ileum); and a urostomy, where urine is drained through an ostomy where normal drainage through the bladder and ureter/urethra is not possible. The stoma may present flush with the surface of the body at the ostomy or may protrude through the ostomy. Typically a bag or other suitable receptacle is attached to the patient's skin on an exterior face of the ostomy to collect bodily fluid as it is discharged from the stoma. It is well documented that the bodily fluids discharged through a stoma can cause significant irritation if they come into contact with the skin surface surrounding the ostomy. It is therefore desirable to seal the connection between the ostomy and an ostomy bag that collects the waste in order to prevent the output from the stoma contacting the skin. However, the fact that each stoma is individually sized and shaped, along with the need to replace the bag and hence break the seal regularly, makes an optimum seal difficult to achieve in practice. One known method of protecting the skin around a stoma from the stoma output is to make use of an ostomy seal. Typically formed of a biocompatible adhesive material such as hydrocolloid, an ostomy seal closely surrounds the ostomy, adhering to the skin on one side and a corresponding hydrocolloid seal around the entrance to an ostomy bag on the other. Hydrocolloid, while providing excellent adherence and skin compatibility, is absorbent. Absorption of stomal output by the hydrocolloid seal that is in contact with the skin can lead to irritation and it is therefore desirable to minimise the contact of the hydrocolloid seal with the output from the stoma. This problem may be mitigated or eliminated by the use of a spout or other apparatus that directs the output from the stoma, typically under gravity, away from the skin into the ostomy bag. EP0197672 describes a urostomy appliance that has a two-part form; a first part comprising a hydrocolloid adhesive pad that surrounds the stoma and a domed receptacle that is positioned over the stoma forming a seal with the hydrocolloid adhesive pad. The domed receptacle has a spout that has an entrance spaced from the skin for attachment to an ostomy bag. The spacing of the spout away from the skin does not direct the output from the stoma to the ostomy bag and allows pooling of stomal output on the hydrocolloid pad leading the instability issues and skin irritation outlined above. WO 2017/167582 describes an ostomy attachment that addresses some of the above problems. A non-absorbent spout is attached to the hydrocolloid seal to effectively direct the output from the stoma to the ostomy bag. This helps avoid the absorbent seal material coming into contact with the ostomy output and at least reduces absorption and the skin issues deriving from this in the way described above. The ostomy attachment of WO 2017/167582, while offering many advantages over the previously existing systems, such as EP0197672, comprises two components: an absorbent, typically hydrocolloid, seal that contacts the skin; and a non-absorbent, spout. Assembling an attachment that comprises a flexible component made of a non-absorbent materials and a seal made of absorbent material such as hydrocolloid remains a challenge because of the hydrocolloid material's propensity to lose its structural integrity as it begins to absorb effluent from a stoma. If the hydrocolloid loses its structural integrity, there may be a risk of the flexible, non-absorbent component separating from the hydrocolloid leading to output from the stoma failing to be effectively directed from the skin, leaks from the attachment, or perhaps the ostomy bag falling off. Furthermore, prior art ostomy attachments that are currently used by patients do not comprise a spout. In these devices a seal, typically formed of hydrocolloid is applied to the skin around the stoma and then an ostomy bag is attached to this via a corresponding seal on the bag. In the device of WO 2017/167582, the spout is either provided pre-fabricated as part of the seal, in which case, the ostomy bag must be attached by the patient after negotiating the spout, or the spout must be first applied to the sea