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

Teliatry Inc. received a $768,138 project grant award from the National Institutes of Health's National Institute of Biomedical Imaging and Bioengineering to develop a minimally invasive, single incision, rechargeable spinal cord stimulation system for chronic pain management. The grant was awarded under the Discovery and Applied Research for Technological Innovations to Improve Human Health program.

Through this award, Teliatry will engineer the world's smallest (0.75cc), most cost-effective spinal cord stimulator system that eliminates the need for tunneling wires and creating an implantable pulse generator pocket through surgery. The company's novel shape memory polymer lead can be inserted percutaneously and "unrolls" in the epidural space to function as a paddle. Integrated high surface area, low polarization titanium nitride electrodes and a miniature solid state battery architecture are designed to significantly reduce energy needs and battery replacement surgeries over the lifetime of the implant. If successful, this technology could help mainstream spinal cord stimulation therapy for chronic pain.

Abstract

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