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Peripheral Nerve Injuries
Peripheral Nerve Injuries
Peripheral nerve injuries (PNIs), caused by compression or laceration, account for up to 2.8% of traumatic injuries and can lead to neuropathy or muscle atrophy if untreated. Mild cases like neurapraxia involve temporary conduction blocks due to demyelination and often recover without intervention. More severe injuries, such as axonotmesis and neurotmesis, involve axon and tissue damage that impair regeneration and often require surgical repair. Although natural axon regeneration can restore function, disruption of nerve structure can misguide regrowth, delaying or preventing recovery. With axons growing about 1 inch per month, injuries farther from the spinal cord demand timely clinical decisions. Typically, regeneration is assessed after 3–6 months, though immediate surgery can improve outcomes in cases of complete nerve severance.
Electrodes and Stimulation
Electrodes and Stimulation
NAP measurements reflect the summed electrical activity of axons, offering insights into axon regeneration, myelination, and tissue integrity. During surgery, intraoperative nerve conduction studies (NCS) help localize nerve injuries by stimulating the nerve and recording NAP amplitude and frequency. Typically, one electrode set stimulates distally while another records proximally along the nerve. Electrodes, placed on the nerve surface to avoid damage, create uneven current distribution with reduced intensity at the axon-rich center.
Electrodes are classified by pole count. Monopolar and bipolar types have limited specificity due to current spread, making them less ideal for stimulation. Tripolar electrodes, featuring an anode between two cathodes, minimize current spread and stimulus artifact by directing current through shorter, controlled paths.
Prior Technology in the Field
Prior Technology in the Field
Standard equipment: Hooked tripolar stimulating electrode and an equivalent bipolar recording electrode
Caldwell’s disposable triple hook probe series
Checkpoint Surgical
Guardian and Gemini Systems
Each of these prior technologies require one stimulating probe and one recording probe, rely on large, non-portable EMG machines, take no measurements, are hard to operate with, and costly.
Goals
Goals
The primary goals of this project are centered around ergonomic design, enhanced signal acquisition, and biocompatibility. First, the device aims to feature an ergonomic handle to improve ease of use, reduce user fatigue during operation, and enable faster procedural execution. Second, it seeks to enhance signal acquisition by minimizing stimulus artifacts, lowering required input voltage, strengthening signal quality, and preventing iatrogenic peripheral nerve injury (PNI). Lastly, the device is designed with biocompatibility in mind, focusing on minimizing the risk of injury or inflammation and ensuring compliance with FDA regulations for Class II medical devices.
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