title: Benchmarking the ERG valve tip and MRI Interventions Smart Flow neurocatheter convection-enhanced delivery system's performance in a gel model of the brain: employing infusion protocols proposed for gene therapy for Parkinson's disease.
abstract: Convection-enhanced delivery (CED) is an advanced infusion technique used to deliver therapeutic agents into the brain. CED has shown promise in recent clinical trials. Independent verification of published parameters is warranted with benchmark testing of published parameters in applicable models such as gel phantoms, ex vivo tissue and in vivo non-human animal models to effectively inform planned and future clinical therapies. In the current study, specific performance characteristics of two CED infusion catheter systems, such as backflow, infusion cloud morphology, volume of distribution (mm(3)) versus the infused volume (mm(3)) (Vd/Vi) ratios, rate of infusion (µl min(-1)) and pressure (mmHg), were examined to ensure published performance standards for the ERG valve-tip (VT) catheter. We tested the hypothesis that the ERG VT catheter with an infusion protocol of a steady 1 µl min(-1) functionality is comparable to the newly FDA approved MRI Interventions Smart Flow (SF) catheter with the UCSF infusion protocol in an agarose gel model. In the gel phantom models, no significant difference was found in performance parameters between the VT and SF catheter. We report, for the first time, such benchmark characteristics in CED between these two otherwise similar single-end port VT with stylet and end-port non-stylet infusion systems. Results of the current study in agarose gel models suggest that the performance of the VT catheter is comparable to the SF catheter and warrants further investigation as a tool in the armamentarium of CED techniques for eventual clinical use and application.
authors.affiliation: Department of Neurological Surgery, University of Wisconsin, Madison, WI 53792, USA. sillay@neurosurgery.wisc.edu
authors.forename: Karl
authors.initials: K
authors.lastname: Sillay
authors.forename: Dominic
authors.initials: D
authors.lastname: Schomberg
authors.forename: Angelica
authors.initials: A
authors.lastname: Hinchman
authors.forename: Lauren
authors.initials: L
authors.lastname: Kumbier
authors.forename: Chris
authors.initials: C
authors.lastname: Ross
authors.forename: Ken
authors.initials: K
authors.lastname: Kubota
authors.forename: Ethan
authors.initials: E
authors.lastname: Brodsky
authors.forename: Gurwattan
authors.initials: G
authors.lastname: Miranpuri
mesh_terms: D000465:Algorithms; D019985:Benchmarking; D001672:Biocompatible Materials; D001921:Brain / Q000502:physiology*; D057785:Catheters; D004396:Coloring Agents; D003201:Computers; D003627:Data Interpretation, Statistical; D016503:Drug Delivery Systems; D005782:Gels; D015316:Genetic Therapy / Q000379:methods*; D006801:Humans; D015918:Infusion Pumps, Implantable; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008959:Models, Neurological; D010300:Parkinson Disease / Q000235:genetics / Q000628:therapy*; D012685:Sepharose
chemical_list: D001672:Biocompatible Materials; D004396:Coloring Agents; D005782:Gels; D012685:Sepharose