IRRAS is developing new features for the IRRAflow™ CNS System as well as breakthrough technologies and practical solutions to meet the challenges of fluid control and management for a broad range of therapeutic applications and procedures.
CAUTION – This is currently an investigational device. Limited by United States law to investigational use and is exclusively for clinical investigations in the EU.
Problem: Effective and Targeted Drug Delivery to the Brain for CNS Pathologies
The blood-brain barrier (BBB) is formed by the brain capillary endothelium and excludes from the brain 100% of large-molecule neuro-therapeutics and more than 98% of all small-molecule drugs 5. There is currently no efficient way to deliver a drug to a CNS Pathology.
Existing Direct CNS Drug Delivery Devices, that by-pass the BBB, fall into four categories:
- Infusion Pumps
- Implants releasing drugs
- Controlled-release microchips
All the above systems have restricted efficacy in clinical routines because of their failure to achieve therapeutic drug concentrations at target cells for sufficient time. They cannot deliver enough volume of drug solutions targeted to the specific site, since they are not designed to continuously compensate for the rise of intracranial pressure they provoke.
Solution: Intelligent and Targeted Drug Delivery in the Brain
IRRAS is developing an intelligent Direct Drug Delivery feature for the IRRAflow™ device for Central Nervous System pathologies that safely and accurately delivers therapeutic drug volumes, evacuates harmful fluid collections, monitors intracranial pressure and compensates for increased pressure due to infusion. We are developing IRRAflow™ to both infuse a drug, such as an anticoagulant like tPA, and aspirate the haematoma in one process. Or, respectively, infuse an antibiotic and aspirate an abscess, infuse anticancer drugs and aspirate malignant cellular debris.
Problem: Early Detection of Rising Intracranial Pressure
The most significant factor determining morbidity and mortality in patients with a neurosurgical brain disorder is increased intracranial pressure (ICP). An increase in ICP can cause deleterious effects on the brain and is a common pathway to death for these patients4. ICP monitoring of them is thus a clinical routine.
There are no clinical indicators at an early stage of increasing ICP that can forestall a further life threatening rise. Periodic measurement of Elastance (the resistance to outward expansion of an intracranial mass) can reliably predict a patient’s ICP trend and allow timely therapeutic interventions. No elastance measurement system exists today due to the high risk of infection associated to the measurement maneuver (periodic infusion of fluid intracranially).
Solution: IRRAS Brain Elastance Monitoring
IRRAflow™ can periodically infuse I ml of physiological fluid intracranially and measures ICP, enabling the calculation of brain elastance. As an integrated early warning system for possible harm from rapidly increasing ICP as well as providing the means to instantly decrease that ICP through changes in aspiration rate, this feature should show a significant and positive results in neurosurgical patient outcomes.
IRRAS plans to integrate an intelligent Brain Elastance Monitoring feature to safely and accurately monitor and manage intracranial pressure. The IRRAflow™ CNS System, with additional software and sensors will continuously monitor elastance and ICP trends providing a significant feature upgrade. This continuous monitoring could signal patient distress earlier and more reliably than current methods, allowing for earlier therapeutic interventions and better patient outcomes.
Potential Therapeutic Applications For The IRRAflow™ Device
- Treatments for infections and malignant tumors:
- Ventriculitis, Meningitis, Abscesses and Osteomyelitis of the skull
- Gliomas and Metastatic brain tumors
- Treatments for Peritoneal, Thoracic and Orthopeadic abscesses and Malignant Tumors.
4 Hoefnagel, D., Dammers, R., Ter Laak-Poort, M. P., & Avezaat, C. J. (2008). Risk factors for infections related to external ventricular drainage. Acta neurochirurgica, 150(3), 209-214; discussion 214
5 Yukio Ikeda, Hiroyuki Uchino, and Ryoichi Miyashita, Neuroanesthesia and Cerebrospinal Protection Chapter 15 : Role and Management of Intracranial Pressure in Neuroanesthesia