A new device for hernia prevention in ostomised patients

Although the are no official registers, according to the White Paper on Osteotomy. Libro Blanco de la Ostomía (1), it has been estimated that there are approximately 70,000 ostomised patients in Spain, i.e., people who, due to diseases such as colorectal cancer, had to be operated on to externalise the intestine or the urinary system and are forced to use an external pouch. An osteotomy is an operation that can significantly worsen quality of life for patients as specialised care is required and parastomal hernias could appear. which are lesions involving the area of the abdomen where the incision is made.

In Spain, 16,000 new ostomised patients are reported every year. Most of the ostomies, approximately 60% of them, are temporary whilst the remaining 40% are permanent. Of the nearly 70,000 ostomised patients it has been estimated that about 55% of them have undergone a colostomy (colon), 35% an ileostomy (ileus) and the other remaining 10% a urostomy (urinary system). Colorectal cancer is the pathology for which ostomies are required most frequently.

Nowadays, however, the solutions available to ostomised patients as regards preventing parastomal hernias are not optimum as cases of this kind have been reported in more than 50% of the patients and only 10% - 15% of them undergo a reparative surgical operation.

Anatomic Fixation Band

In order to improve quality of life for ostomised patients and prevent the onset of lesions of this kind, Tekniker, a member of the Basque Research and Technology Alliance (BRTA), is currently collaborating with Fundación para la Investigación Biomédica del Hospital 12 de Octubre in Madrid to design an osteotomy fixation device for the prevention of parastomal hernias.

This solution comprises three elements: a base that is placed on the abdomen on either side of the stoma or incision, an easy-to-use, anatomically shaped protective shield and a fixation band to adapt the device to the area of the stoma and apply uniform compression on the abdomen. The design is protected by a patent and is based on an initiative involving an ostomised patient and the nursing staff at the hospital where it been possible to carry out this project thanks to the support provided by the Innovation Support Unit of the Health Care Research Institute at Hospital 12 de Octubre.

More specifically, Tekniker was able to make several proposals focused on redesigning and optimising the product thanks to its high degree of specialisation in terms of designing, developing and manufacturing precision equipment. Moreover, functional and biocompatible materials were used to manufacture all the parts required. Consequently, it is easy to manufacture all the device’s components according to profitability and product economy parameters to subsequently move into the industrialisation stage.

In phase one, the technology centre studied the functions to be performed by the device as well product ergonomy, the use of different materials and their orientation in terms of scalable parts to implement industrial production. During this phase, it was essential to bear in mind the views expressed by the ostomised patients themselves and their nursing staff.

Validation and use testing

Phase two of this process consisted in selecting the most suitable materials, developing all the details related to the device and defining the most suitable production resources to be used for manufacturing. Tekniker has assembled the prototypes for validation purposes. Consequently, an investigative study will be carried on newly ostomised patients by the Invecuid care research team supervised by nurses. This study will assess the degree of efficacy achieved by the device in terms of preventing parastomal hernias.

In the final stage, a report addressing the project’s industrial viability will be released to select optimum industrial processes as well as potential suppliers as a function of the number of units to be manufactured.

(1) All data supplied by the White Paper on Osteotomy Libro Blanco de la Ostomía.

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