Abstract
Approximately 60% of all spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) doses for pain management are reduced by the 360° stimulation field limitations of the cylindrical percutaneous lead (CPL). With CPL, only 30% of the therapy dose is pointed towards the nerve target. [1] Poor dosing efficiency results in higher stimulation therapy amplitude, 2x higher recharge burden and more frequent battery replacement surgery. [2, 3] Multi-contact programming and novel high frequency waveforms further multiply these dosing inefficiencies. We demonstrate a self-opening injectable micro-paddle in cadavers and sheep. After deploying through a 13-gauge Tuohy needle, the lead self-opens to form a 4 mm wide micro-paddle with a unidirectional stimulation field. We performed fluoroscopy during deployment and benchmarked the retraction forces in comparison with cylindrical leads. We further developed a platinum-iridium surface processing which improves the charge injection density by 2x over conventional leads.
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