A minimally invasive, single incision, rechargeable spinal cord Stimulation system for chronic pain

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Project Summary Teliatry proposes to build world’s smallest (0.75cc), most cost-effective, minimally invasive single incision surgery, 16-channel, rechargeable, Spinal Cord Stimulator (SCS) system to bring proven SCS therapy to mainstream chronic pain management. It eliminates the need for creating an IPG pocket, eliminates tunneling, exploits a novel shape memory polymer (SMP)lead that can be inserted percutaneously without altering current surgical technique but “unrolls” into a paddle in epidural space. It also softens to conform to the epidural space mitigating issues with lead migration and lead breakage. The electrodes on the paddle are high surface area, low polarization, fractal topology Titanium Nitride (TiN) that further reduce the energy required by up to 70% of percutaneous cylindrical electrodes. This in turn reduces the battery capacity requirement and allows us to exploit a miniature, multi-stack solid state battery (SSB) architecture that is manufactured at wafer level on a glass substrate. It is intrinsically safe, MRI compatible and has extremely high charge & discharge rate (20C) and high recharge cycle (2000+) equating to 10+ years lifetime. This further eliminates the need for repeat battery replacement surgery every few years. In recent times, miniature, battery less SCS systems have entered the market but they limit patients comfort and lifestyle by forcing external power & communications module(PCM) to be worn at all times and also have issues with alignment of the PCM with the implant for proper power coupling. Our proposed system is even smaller than these batteries less system and with an average recharge time of <10 minute/day in the worst case, it eliminates the external wearable PCM and long recharge cycles wait time that hinder patient’s lifestyle. In addition, our systems low production costs due to parallel fabrication of multiple implants on one glass wafer will improve the short-term cost effectiveness (currently @ 40%) to its long term cost effectiveness (80%) making this a mainstream electroceutical for pain management and in turn reducing dependence on Opioids for chronic pain sufferers. We will perform feasibility study on all critical components and aspects of the system architecture in Phase 1 allowing us to build a successful prototype during Phase 2. We propose a system design including IPG architecture, battery and lead design that are all based on our proven technology and will enable us to realize a novel SCS system by synergistically combining advantages and on-going advancements of these core technologies 1) glass IPG, 2) glass SSB, 3)new softening and unrolling leads. SCS therapy for chronic back pain is our prime target specially because there is high level of evidence for safety, efficacy, and long-term cost-effectiveness of SCS with more than half of all patients experiencing sustained and significant levels of pain reduction following SCS treatment. We believe we will not only bring SCS to mainstream pain management, but our modular technology platform will impact the entire neuromodulation industry.