Research Project
9688656
This Phase I SBIR will develop and test feasibility of a Peripheral Nerve Targeting (PNT) system for inserting penetrating neural electrode arrays into tough peripheral nerve targets, with an initial clinical focus on restoring bladder function. The approach will allow complete insertion of multichannel electrode implants into target nerves, with improved access to fascicles. The system will facilitate: a) improved mapping of the neural structures controlling urinary function, and ultimately b) development of clinical tools for electrode placement into peripheral structures for urinary function restoration. Problem to be solved: The ability to store and periodically eliminate urine is regulated by a dynamic neural circuit integrating information from the brain, spinal cord and peripheral autonomic ganglia. The current clinical standard treatment of bladder control defects is catheterization; however all forms of catheterization are associated with risk of infection. Neural Implants: Some of the most promising treatment alternatives currently under development incorporate electrical control of the bladder. The effectiveness of existing electrical stimulation devices is limited, however, by the inability to surgically access the target safely, difficulty in placing the electrodes, and limited specificity of stimulation. An interface enabling spatially specific activation of nerve fascicles, as provided by penetrating multichannel electrodes, would yield significantly better outcomes. However, implantation of penetrating electrodes into nerves remains a great challenge. Piercing the epineurium requires the electrode to withstand forces which may buckle or break the electrode. The insertion force is substantial enough to compress, stretch and/or roll the targeted nerve, which can prohibit electrode insertion, increase the risk of tissue trauma, and accentuate the chronic foreign body response that leads to cell death, tissue scaring and device failure. This project develops a novel Peripheral Nerve Targeting (PNT) system to improve the ability to insert penetrating electrodes into peripheral nerves. The PNT system employs a nerve stabilization feature combined with vibration of the penetrating electrode array to reduce insertion force, ultimately increasing insertion success while reducing strain and trauma to the nerve. Hypothesis: Vibration of penetrating neural electrode arrays through stabilized epineurium will reduce insertion force and mechanical strain on the nerve to significantly increase success rate (>80%) for complete insertion into peripheral nerve targets. Aim 1: Identification of insertion parameters (oscillation frequency, displacement amplitude, angle of approach, and insertion speed) for reliable, reduced-force insertion of single-shank penetrating electrodes through epineurium. Aim 2: Development and evaluation of handheld PNT system with automated vibration-aided insertion and integrated nerve/epineurium stabilization features. Aim 3: Confirm that the PNT system improves success rate of penetrating electrode insertions into peripheral nerves and dorsal root ganglion.
