Reliability and performance of the IRRAflow® system for intracranial lavage and evacuation of hematomas-A technical note

Mette Haldrup ¹, Mojtaba Nazari ², Chenghao Gu ¹

⁰Department of Neurosurgery, Aarhus University Hospital, Aarhus N, Denmark.

Plos One +

|

April 16, 2024

View abstract on PubMed

Summary

The IRRAflow® system for intraventricular hemorrhage (IVH) clearance shows unreliable intracranial pressure (ICP) monitoring and incompatibility with certain bolts. Optimized settings are identified for effective lavage, but a separate ICP monitor is recommended.

Area Of Science

Neurosurgery
Medical Device Technology
Critical Care Medicine

Background

Intraventricular hemorrhage (IVH) presents significant challenges with high mortality rates.
IRRAflow® offers a minimally invasive approach for IVH clearance via controlled irrigation and aspiration.
The system aims to maintain stable intracranial pressure (ICP) during treatment.

Purpose Of The Study

Evaluate the compatibility of the IRRAflow® catheter with the Silverline f10 bolt.
Assess the physiological and hydrodynamic effects of varying IRRAflow® settings.
Determine the accuracy of IRRAflow® injection volumes and the reliability of its internal ICP monitor.

Main Methods

An ex vivo laboratory setup was designed for versatile investigation of device parameters.
Compatibility testing was performed between the IRRAflow® catheter and Silverline bolt.
IRRAflow® settings were systematically varied to analyze effects on irrigation and drainage.
Accuracy of injection volumes and reliability of the internal ICP monitor were evaluated against a control.

Main Results

The IRRAflow® catheter demonstrated incompatibility with the Silverline bolt, leading to leakage and obstruction.
Optimal IRRAflow® settings were identified, balancing irrigation rates and drainage bag height.
IRRAflow® injection volumes were found to be stable and reliable.
The internal ICP monitor exhibited significant drift and compromised accuracy compared to a control monitor.

Conclusions

The use of the Medtronic Silverline® bolt with the IRRAflow® catheter is not recommended due to compatibility issues.
Specific irrigation rates and drainage bag levels are recommended for effective intracranial lavage.
The IRRAflow® device's internal ICP monitoring is unreliable and necessitates the use of a concurrent control ICP monitor in clinical practice.