A reported 165,000 – 200,000 people in the United Kingdom live with an ostomy bag, the result of a life saving surgery that allows bodily waste to pass through a surgically created stoma in the abdomen. There are a wide range of reasons why an individual may require an ostomy bag as a result of health issues, ranging from Crohn’s disease, bowel cancer, diverticular disease an infection or burst abscess, or an injury or obstruction to the digestive system, the result of the surgery is a stoma, a small opening where a pouch is attached to collect bodily waste. Stomas or Ostomy bags as they are often referred to can be a temporary requirement whilst the digestive system heals and recovers, and in other instances a permanent addition to an individual’s life. In light of Ostomy Awareness Day 2023 and as a key contributor to the manufacture of ostomy components PolarSeal understand the importance of patient comfort, ease of use and improved quality of life.
The importance of the Ostomy Bag Design
During the surgical procedure an ostomy is created, which is essentially an opening in the abdomen to allow waste to exit the body, an Ostomy bag is a medical device that attaches to the Ostomy and the user wears the device to collect the bodily waste that would normally be expelled by the body prior to surgery. The bag is made up of a number of components designed with ease of use and comfort for the user in mind and the manufacturing of an ostomy bags involves a combination of specialized materials, assembly processes, and quality control measures to ensure they are safe, reliable, and comfortable for users.
Material Selection and Preparation
The primary materials used in ostomy bag production are usually medical-grade plastics like polyethylene or polyurethane for the pouch and low friction non-woven that covers the plastic pouch so it does not cause abrasion to the skin when moving, and skin-friendly adhesives for the flange and hydrocolloid (the part that adheres to the skin) other materials like acrylic adhesives are utilized to attach performance components to the bag. These materials are selected for their durability, flexibility, and biocompatibility.
Extrusion and Film Formation
The plastic materials are typically processed through an extrusion process. This involves melting the plastic and shaping it into a flat, continuous film. This film will serve as the base material for the pouch.
Die Cutting or Forming
Using specialized dies or moulds, the flat film is cut or formed into the desired shape of the pouch. This can include the main body of the pouch, as well as any additional features like filters or closures.
Adhesive Application
Skin-friendly adhesives are applied to the flange portion of the pouch. These adhesives are designed to be gentle on the skin, yet provide a secure and leak-proof seal. PSA’s or pressure sensitive adhesives are used to bond together the pouch and wafer, the advantages of both one piece and two piece designs if they enable repeatable and secure attachment of the pouch and wafer, yield a low profile device, and provide reliable containment of effluent.
Assembling the Pouch
The pouch is assembled, often in multiple layers. For example, a two-piece system would include a pouch and a separate flange, sometimes called a baseplate or wafer that attaches to the skin. The wafer can be designed with a printed liner for cutting ostomy hole personalisation.
Adding Features
Depending on the design and type of ostomy bag, additional features may be added. This could include filters to release gas and prevent ballooning, carbon or charcoal filters for odour prevention, closures for easy emptying such as hook and loop, and comfort features like soft backing, hydrocolloid bag to body attachments and non-woven tapes.
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