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Published on: September 17, 2015
Large-Volume Infusions into the Brain: A Comparative Study of Catheter Designs
Martin L Brady1, Raghu Raghavan1, Jaime Mata2
1Therataxis LLC, Baltimore, Maryland, USA.
Background/Aims:
"Whole-brain" infusions have emerged as a potential need with the promise of disease-modifying therapies for neurodegenerative diseases. In addition, several current clinical trials in brain cancer utilize direct delivery of drugs that are required to fill large volumes. Such requirements may not be well served by conventional single port catheters with their "point source" of delivery. Our aim is to examine infusions into large volumes of heterogeneous tissue, aiming for uniformity of distribution.
Methods:
A porous catheter (porous brain infusion catheter, PBIC), designed by Twin Star TDS LLC, for brain infusions was developed for this study and compared with another convection-enhanced delivery catheter (SmartFlowTM NGS-NC-03 from MRI Interventions, a step end-port catheter, SEPC) in current use in clinical trials. The studies were in vivo in porcine brain. A total of 8 pigs were used: the size of the pig brain limited the porous length to 15 mm. The placements of the tips of the two catheters were chosen to be the same (at the respective brain hemispheres).
Results:
The PBIC and SEPC both performed comparably and well, with the PBIC having some advantage in effecting larger distributions: p ∼ 0.045, with 5 infusions from each.
Conclusions:
Given the performance of the PBIC, it would be highly appropriate to use the device for therapeutic infusions in human clinical trials to assess its capability for large-volume infusions.
Insights
A novel porous brain infusion catheter (PBIC) shows promise for uniform drug delivery in large brain volumes. This new catheter may improve treatments for neurodegenerative diseases and brain cancers.
Area of Science:
- Neurosurgery
- Biomedical Engineering
- Drug Delivery Systems
Background:
- Whole-brain infusions are crucial for treating neurodegenerative diseases and brain cancers.
- Current single-port catheters may not adequately deliver drugs to large brain volumes.
- Uniform drug distribution is essential for effective disease-modifying therapies.
Purpose of the Study:
- To evaluate a novel porous brain infusion catheter (PBIC) for large-volume infusions.
- To compare the PBIC's distribution performance against a conventional step-end port catheter (SEPC).
- To assess the potential of the PBIC for therapeutic applications in human clinical trials.
Main Methods:
- A porous brain infusion catheter (PBIC) was designed and tested.
- In vivo studies were conducted in porcine brains (n=8).
- The PBIC was compared with a step-end port catheter (SEPC) using identical catheter tip placements.
Main Results:
- Both the PBIC and SEPC demonstrated comparable performance.
- The PBIC showed a statistically significant advantage in achieving larger drug distributions (p ≈ 0.045).
- Five infusions were performed with each catheter type.
Conclusions:
- The PBIC demonstrates effective large-volume infusion capabilities.
- The device is suitable for further investigation in human clinical trials.
- The PBIC offers a promising solution for uniform drug delivery in the brain.
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