ONIRY

About the device

The device idea comes from consequences, which some patients had after natural delivery and sometimes were quite severe, such fecal incontinence. To help patients a doctor can execute a “Primary Repair” treatment, which may be done up to 48 hours after birth. However, due to the low rate of issue discovery, this seldom occurs in practice. As an alternative a healthcare professional can carry out the sphincteroplasty treatment after around six months, although it is significantly more challenging and less successful.

This medical device is designed to provide a quick and painless diagnose postpartum sphincter muscle injuries and determine the location of the injury. The bioimpedance method is used to perform the measurements.

ONIRY device consists of 2 most important pieces: an electrode probe and an impedance spectrometer. The electrode probe with an elongated rounded shape is inserted into the body cavity.
This tool is divided into a head, a body with silver electrodes, a handle and a cable with a connector. During the design proces we slightly widened head shape to guarantee good positioning of the human body.

The whole procedure relies on an electrical impedance-based physical biomarker. The tissue where the rip or rupture occurred is thought to have altered properties. Therefore, the perspective required for future therapy may be obtained by using the impedance spectroscopy approach and studying the tissue by rotating the anal sphincter muscle 360 degrees. The data may then be evaluated for which metrics they indicate a change has taken place using machine learning techniques.

After some attempts we have found that bioimpedance measurement method in a tetrapolar configuration is the best solution for the job. The method consists in delivering current impulses of different frequencies through two external electrodes on the probe and then measuring the electrical impedance between the inner electrodes.

We achieved that by linking several services:

Prototyping, Engineering, Production, Certification