ACTUATED MEDICAL, INC. SBIR Phase I Award, September 2018

This Phase I SBIR will develop and test feasibility of a Peripheral Nerve TargetingPNTsystem for inserting penetrating neural electrode arrays into tough peripheral nerve targetswith an initial clinical focus on restoring bladder functionThe approach will allow complete insertion of multichannel electrode implants into target nerveswith improved access to fasciclesThe system will facilitateaimproved mapping of the neural structures controlling urinary functionand ultimately bdevelopment of clinical tools for electrode placement into peripheral structures for urinary function restorationProblem to be solvedThe ability to store and periodically eliminate urine is regulated by a dynamic neural circuit integrating information from the brainspinal cord and peripheral autonomic gangliaThe current clinical standard treatment of bladder control defects is catheterizationhowever all forms of catheterization are associated with risk of infectionNeural ImplantsSome of the most promising treatment alternatives currently under development incorporate electrical control of the bladderThe effectiveness of existing electrical stimulation devices is limitedhoweverby the inability to surgically access the target safelydifficulty in placing the electrodesand limited specificity of stimulationAn interface enabling spatially specific activation of nerve fasciclesas provided by penetrating multichannel electrodeswould yield significantly better outcomesHoweverimplantation of penetrating electrodes into nerves remains a great challengePiercing the epineurium requires the electrode to withstand forces which may buckle or break the electrodeThe insertion force is substantial enough to compressstretch and or roll the targeted nervewhich can prohibit electrode insertionincrease the risk of tissue traumaand accentuate the chronic foreign body response that leads to cell deathtissue scaring and device failureThis project develops a novel Peripheral Nerve TargetingPNTsystem to improve the ability to insert penetrating electrodes into peripheral nervesThe PNT system employs a nerve stabilization feature combined with vibration of the penetrating electrode array to reduce insertion forceultimately increasing insertion success while reducing strain and trauma to the nerveHypothesisVibration of penetrating neural electrode arrays through stabilized epineurium will reduce insertion force and mechanical strain on the nerve to significantly increase success rateandgtfor complete insertion into peripheral nerve targetsAimIdentification of insertion parametersoscillation frequencydisplacement amplitudeangle of approachand insertion speedfor reliablereduced force insertion of single shank penetrating electrodes through epineuriumAimDevelopment and evaluation of handheld PNT system with automated vibration aided insertion and integrated nerve epineurium stabilization featuresAimConfirm that the PNT system improves success rate of penetrating electrode insertions into peripheral nerves and dorsal root ganglion Project NarrativeRelevanceThe ability to store and periodically eliminate urine is regulated by a dynamic neural circuit integrating information from the brainspinal cord and peripheral nervous systemFor restoring urinary function in damaged systemssome of the most promising treatment options under development are for electrical control of the bladderwhich would avoid the infection risk and cost of mechanical solutions and catheterizationas well as the systemic problems from drug therapiesThe effectiveness of electrical stimulation devices is limited by a number of factors including the stimulation targetthe type of stimulating electrodesurgical access to nervesand the device longevityThis project develops a new Peripheral Nerve TargetingPNTsystemenhancing electrode placement accuracy and functionality