Flat Interface Nerve Electrode Research Articles

Selective chronic recording in small nerve fascicles of sciatic nerve with carbon nanotube yarns in rats

Objective. The primary challenge faced in the field of neural rehabilitation engineering is the limited advancement in nerve interface technology, which currently fails to match the mechanical properties of small-diameter nerve fascicles. Novel developments are necessary to enable long-term, chronic recording from a multitude of small fascicles, allowing for the recovery of motor intent and sensory signals. Approach. In this study, we analyze the chronic recording capabilities of carbon nanotube yarn electrodes in the peripheral somatic nervous system. The electrodes were surgically implanted in the sciatic nerve’s three individual fascicles in rats, enabling the recording of neural activity during gait. Signal-to-noise ratio (SNR) and information theory were employed to analyze the data, demonstrating the superior recording capabilities of the electrodes. Flat interface nerve electrode and thin-film longitudinal intrafascicular electrode electrodes were used as a references to assess the results from SNR and information theory analysis. Main results. The electrodes exhibited the ability to record chronic signals with SNRs reaching as high as 15 dB, providing 12 bits of information for the sciatic nerve, a significant improvement over previous methods. Furthermore, the study revealed that the SNR and information content of the neural signals remained consistent over a period of 12 weeks across three different fascicles, indicating the stability of the interface. The signals recorded from these electrodes were also analyzed for selectivity using information theory metrics, which showed an information sharing of approximately 1.4 bits across the fascicles. Significance. The ability to safely and reliably record from multiple fascicles of different nerves simultaneously over extended periods of time holds substantial implications for the field of neural and rehabilitation engineering. This advancement addresses the limitation of current nerve interface technologies and opens up new possibilities for enhancing neural rehabilitation and control.

Implanted High Density Cuff Electrodes Functionally Activate Human Tibial and Peroneal Motor Units Without Chronic Detriment to Peripheral Nerve Health

Peripheral nerve stimulation via multi-contact nerve cuff electrodes (NCEs) has proved effective in restoring function to individuals with lower-extremity paralysis. This study investigates clinical measures of nerve health over one year post-implantation of a composite flat-interface nerve electrode (C-FINE) on the tibial and peroneal nerves above the knee in a human volunteer. This represents the first deployment of a novel NCE on new neural targets in a uniquely challenging location prone to prolonged externally applied forces, making acute and chronic postoperative observation critical. A 27-year-old man with an incomplete spinal cord injury (AIS C) at the C3 to C4 level received eight-contact C-FINEs bilaterally on the tibial and peroneal nerves, proximal to the knee. Access to four contacts per cuff exhibiting the most desirable responses was externalized via temporary percutaneous leads. Percutaneous leads were later removed, with contacts generating the best dorsiflexion (two of four) and plantar flexion (one of four) reconnected to a permanently implanted pulse generator. For 13 months post-implantation, nerve health and cuff performance were assessed through motor nerve conduction velocity (MNCV) studies, clinical needle electromyography, compound motor action potential (CMAP), sensory nerve action potential (SNAP), stimulation-evoked tetanic moment collection, and lower-limb circumference measurements. Tibial and peroneal MNCVs remained stable bilaterally above 40 m/sec, with CMAPs increased or stable after six months. SNAPs remained stable across all measurements. CMAP initial charge thresholds remained below 50 nC, with minimal changes to muscle recruitment order in three of four externalized contacts per cuff. Peak tetanic moments remained stable, with bilateral increases in thigh and calf circumferences of 5% and 14% over one year. Above-knee tibial and peroneal NCEs can restore stimulated ankle-joint function without chronic nerve health detriments. Alongside previous femoral nerve data, this study demonstrates the ability of NCEs to enhance lower-extremity function with limited neuromuscular impact.

Chronic nerve health following implantation of femoral nerve cuff electrodes

BackgroundPeripheral nerve stimulation with implanted nerve cuff electrodes can restore standing, stepping and other functions to individuals with spinal cord injury (SCI). We performed the first study to evaluate the clinical electrodiagnostic changes due to electrode implantation acutely, chronic presence on the nerve peri- and post-operatively, and long-term delivery of electrical stimulation.MethodsA man with bilateral lower extremity paralysis secondary to cervical SCI sustained 5 years prior to enrollment received an implanted standing neuroprosthesis including composite flat interface nerve electrodes (C-FINEs) electrodes implanted around the proximal femoral nerves near the inguinal ligaments. Electromyography quantified neurophysiology preoperatively, intraoperatively, and through 1 year postoperatively. Stimulation charge thresholds, evoked knee extension moments, and weight distribution during standing quantified neuroprosthesis function over the same interval.ResultsFemoral compound motor unit action potentials increased 31% in amplitude and 34% in area while evoked knee extension moments increased significantly (p < 0.01) by 79% over 1 year of rehabilitation with standing and quadriceps exercises. Charge thresholds were low and stable, averaging 19.7 nC ± 6.2 (SEM). Changes in saphenous nerve action potentials and needle electromyography suggested minor nerve irritation perioperatively.ConclusionsThis is the first human trial reporting acute and chronic neurophysiologic changes due to application of and stimulation through nerve cuff electrodes. Electrodiagnostics indicated preserved nerve health with strengthened responses following stimulated exercise. Temporary electrodiagnostic changes suggest minor nerve irritation only intra- and peri-operatively, not continuing chronically nor impacting function. These outcomes follow implantation of a neuroprosthesis enabling standing and demonstrate the ability to safely implant electrodes on the proximal femoral nerve close to the inguinal ligament. We demonstrate the electrodiagnostic findings that can be expected from implanting nerve cuff electrodes and their time-course for resolution, potentially applicable to prostheses modulating other peripheral nerves and functions.Trial registrationClinicalTrials.govNCT01923662, retrospectively registered August 15, 2013.

Intraoperative Responses May Predict Chronic Performance of Composite Flat Interface Nerve Electrodes on Human Femoral Nerves.

Peripheral nerve cuff electrodes (NCEs) in motor system neuroprostheses can generate strong muscle contractions and enhance surgical efficiency by accessing multiple muscles from a single proximal location. Predicting chronic performance of high contact density NCEs based on intraoperative observations would facilitate implantation at locations that maximize selective recruitment, immediate connection of optimal contacts to implanted pulse generators (IPGs) with limited output channels, and initiation of postoperative rehabilitation as soon as possible after surgery. However, the stability of NCE intraoperative recruitment to predict chronic performance has not been documented. Here we report the first-in-human application of a specific NCE, the composite flat interface nerve electrode (C-FINE), at a new and anatomically challenging location on the femoral nerve close to the inguinal ligaments. EMG and moment recruitment curves were recorded for each of the 8 contacts in 2 C-FINE intraoperatively, perioperatively, and chronically for 6 months. Intraoperative measurements predicted chronic outcomes for 87.5% of contacts with 14/16 recruiting the same muscles at 6 months as intraoperatively. In both 8-contact C-FINEs, 3 contacts elicited hip flexion and 5 selectively generated knee extension, 3 of which activated independent motor unit populations each sufficient to support standing. Recruitment order stabilized in less than 3 weeks and did not change thereafter. While confirmation of these results will be required with future studies and implant locations, this suggests that remobilization and stimulated exercise may be initiated 3 weeks after surgery with little risk of altering performance.

Recovering Motor Activation with Chronic Peripheral Nerve Computer Interface

Interfaces with the peripheral nerve provide the ability to extract motor activation and restore sensation to amputee patients. The ability to chronically extract motor activations from the peripheral nervous system remains an unsolved problem. In this study, chronic recordings with the Flat Interface Nerve Electrode (FINE) are employed to recover the activation levels of innervated muscles. The FINEs were implanted on the sciatic nerves of canines, and neural recordings were obtained as the animal walked on a treadmill. During these trials, electromyograms (EMG) from the surrounding hamstring muscles were simultaneously recorded and the neural recordings are shown to be free of interference or crosstalk from these muscles. Using a novel Bayesian algorithm, the signals from individual fascicles were recovered and then compared to the corresponding target EMG of the lower limb. High correlation coefficients (0.84 ± 0.07 and 0.61 ± 0.12) between the extracted tibial fascicle/medial gastrocnemius and peroneal fascicle/tibialis anterior muscle were obtained. Analysis calculating the information transfer rate (ITR) from the muscle to the motor predictions yielded approximately 5 and 1 bit per second (bps) for the two sources. This method can predict motor signals from neural recordings and could be used to drive a prosthesis by interfacing with residual nerves.

Evaluation of high-density, multi-contact nerve cuffs for activation of grasp muscles in monkeys

Objective. The objective of this work was to evaluate whether nerve cuffs can selectively activate hand muscles for functional electrical stimulation (FES). FES typically involves identifying and implanting electrodes in many individual muscles, but nerve cuffs only require implantation at a single site around the nerve. This method is surgically more attractive. Nerve cuffs may also more effectively stimulate intrinsic hand muscles, which are difficult to implant and stimulate without spillover to adjacent muscles. Approach. To evaluate its ability to selectively activate muscles, we implanted and tested the flat interface nerve electrode (FINE), which is designed to selectively stimulate peripheral nerves that innervate multiple muscles (Tyler and Durand 2002 IEEE Trans. Neural Syst. Rehabil. Eng. 10 294–303). We implanted FINEs on the nerves and bipolar intramuscular wires for recording compound muscle action potentials (CMAPs) from up to 20 muscles in each arm of six monkeys. We then collected recruitment curves while the animals were anesthetized. Main result. A single FINE implanted on an upper extremity nerve in the monkey can selectively activate muscles or small groups of muscles to produce multiple, independent hand functions. Significance. FINE cuffs can serve as a viable supplement to intramuscular electrodes in FES systems, where they can better activate intrinsic and extrinsic muscles with lower currents and less extensive surgery.

The design of and chronic tissue response to a composite nerve electrode with patterned stiffness

Objective. As neural interfaces demonstrate success in chronic applications, a novel class of reshaping electrodes with patterned regions of stiffness will enable application to a widening range of anatomical locations. Patterning stiff regions and flexible regions of the electrode enables nerve reshaping while accommodating anatomical constraints of various implant locations ranging from peripheral nerves to spinal and autonomic plexi. Approach. Introduced is a new composite electrode enabling patterning of regions of various electrode mechanical properties. The initial demonstration of the composite’s capability is the composite flat interface nerve electrode (C-FINE). The C-FINE is constructed from a sandwich of patterned PEEK within layers of pliable silicone. The shape of the PEEK provides a desired pattern of stiffness: stiff across the width of the nerve to reshape the nerve, but flexible along its length to allow for bending with the nerve. This is particularly important in anatomical locations near joints or organs, and in constrained compartments. We tested pressure and volume design constraints in vitro to verify that the C-FINE can attain a safe cuff-to-nerve ratio (CNR) without impeding intraneural blood flow. We measured nerve function as well as nerve and axonal morphology following 3 month implantation of the C-FINE without wires on feline peripheral nerves in anatomically constrained areas near mobile joints and major blood vessels in both the hind and fore limbs. Main Results. In vitro inflation tests showed effective CNRs (1.93 ± 0.06) that exceeded the industry safety standard of 1.5 at an internal pressure of 20 mmHg. This is less than the 30 mmHg shown to induce loss of conduction or compromise blood flow. Implanted cats showed no changes in physiology or electrophysiology. Behavioral signs were normal suggesting healthy nerves. Motor nerve conduction velocity and compound motor action potential did not change significantly between implant and explant (p > 0.15 for all measures). Axonal density and myelin sheath thickness was not significantly different within the electrode compared to sections greater than 2 cm proximal to implanted cuffs (p > 0.14 for all measures). Significance. We present the design and verification of a novel nerve cuff electrode, the C-FINE. Laminar manufacturing processes allow C-FINE stiffness to be configured for specific applications. Here, the central region in the configuration tested is stiff to reshape or conform to the target nerve, while edges are highly flexible to bend along its length. The C-FINE occupies less volume than other NCEs, making it suitable for implantation in highly mobile locations near joints. Design constraints during simulated transient swelling were verified in vitro. Maintenance of nerve health in various challenging anatomical locations (sciatic and median/ulnar nerves) was verified in a chronic feline model in vivo.

Stable Detection of Movement Intent From Peripheral Nerves: Chronic Study in Dogs

Peripheral nerves provide access to highly processed and segregated neural command signals from the brain that control skeletal muscles. Detecting these signals could provide lifelike, intuitive control of high-degree-of-freedom prosthetic limbs. However, detection of individual fascicle neural activity within a nerve has not yet been accomplished without compromising the nerve. The purpose of this study was to detect fascicular-level neural activity in freely moving animals with nonpenetrating nerve cuff electrodes. Three dogs were implanted with 16-contact flat interface nerve electrodes (FINEs) on the sciatic nerve with total duration of the implant ranging from four to nine months with functional recordings lasting 2.2–7.5 months. The recorded neural activity during normal treadmill walking was used to localize fascicular sources within the nerve and their recovered activity was compared with the ankle movements using binary classification against gait phase. The signal-to-noise ratio (SNR) of the neural signals obtained from the FINE was between 3.65 and 7.59 dB. Postmortem analysis showed that the focal points of the recovered fascicular activity were located within 0.75 $\pm$ 0.38 mm from the nearest major fascicles. The two movement intents recovered from each fascicle matched the actual observed ankle movements with overall accuracy of 70%–80% and false crosstalk rate of < 10%. The significant outcome of this study is detecting multiple voluntary fascicular activities with consistent accuracy over time from freely moving animals. It demonstrates the potential of using the FINE in the designs of intuitively controlled advanced prostheses and ultimately improving patient’s quality of life.

Fabrication of High Contact-Density, Flat-Interface Nerve Electrodes for Recording and Stimulation Applications

Fabrication of High Contact-Density, Flat-Interface Nerve Electrodes for Recording and Stimulation Applications

Fabrication of High Contact-Density, Flat-Interface Nerve Electrodes for Recording and Stimulation Applications.

Many attempts have been made to manufacture multi-contact nerve cuff electrodes that are safe, robust and reliable for long term neuroprosthetic applications. This protocol describes a fabrication technique of a modified cylindrical nerve cuff electrode to meet these criteria. Minimum computer-aided design and manufacturing (CAD and CAM) skills are necessary to consistently produce cuffs with high precision (contact placement 0.51 ± 0.04 mm) and various cuff sizes. The precision in spatially distributing the contacts and the ability to retain a predefined geometry accomplished with this design are two criteria essential to optimize the cuff's interface for selective recording and stimulation. The presented design also maximizes the flexibility in the longitudinal direction while maintaining sufficient rigidity in the transverse direction to reshape the nerve by using materials with different elasticities. The expansion of the cuff's cross sectional area as a result of increasing the pressure inside the cuff was observed to be 25% at 67 mm Hg. This test demonstrates the flexibility of the cuff and its response to nerve swelling post-implant. The stability of the contacts' interface and recording quality were also examined with contacts' impedance and signal-to-noise ratio metrics from a chronically implanted cuff (7.5 months), and observed to be 2.55 ± 0.25 kΩ and 5.10 ± 0.81 dB respectively.

Motion control of the rabbit ankle joint with a flat interface nerve electrode.

A flat interface nerve electrode (FINE) has been shown to improve fascicular and subfascicular selectivity. A recently developed novel control algorithm for FINE was applied to motion control of the rabbit ankle. A 14-contact FINE was placed on the rabbit sciatic nerve (n = 8), and ankle joint motion was controlled for sinusoidal trajectories and filtered random trajectories. To this end, a real-time controller was implemented with a multiple-channel current stimulus isolator. The performance test results showed good tracking performance of rabbit ankle joint motion for filtered random trajectories and sinusoidal trajectories (0.5 Hz and 1.0 Hz) with <10% average root-mean-square (RMS) tracking error, whereas the average range of ankle joint motion was between -20.0 ± 9.3° and 18.1 ± 8.8°. The proposed control algorithm enables the use of a multiple-contact nerve electrode for motion trajectory tracking control of musculoskeletal systems.

Ultra-low noise miniaturized neural amplifier with hardware averaging

Objective. Peripheral nerves carry neural signals that could be used to control hybrid bionic systems. Cuff electrodes provide a robust and stable interface but the recorded signal amplitude is small (<3 μVrms 700 Hz–7 kHz), thereby requiring a baseline noise of less than 1 μVrms for a useful signal-to-noise ratio (SNR). Flat interface nerve electrode (FINE) contacts alone generate thermal noise of at least 0.5 μVrms therefore the amplifier should add as little noise as possible. Since mainstream neural amplifiers have a baseline noise of 2 μVrms or higher, novel designs are required. Approach. Here we apply the concept of hardware averaging to nerve recordings obtained with cuff electrodes. An optimization procedure is developed to minimize noise and power simultaneously. The novel design was based on existing neural amplifiers (Intan Technologies, LLC) and is validated with signals obtained from the FINE in chronic dog experiments. Main results. We showed that hardware averaging leads to a reduction in the total recording noise by a factor of 1/√N or less depending on the source resistance. Chronic recording of physiological activity with FINE using the presented design showed significant improvement on the recorded baseline noise with at least two parallel operation transconductance amplifiers leading to a 46.1% reduction at N = 8. The functionality of these recordings was quantified by the SNR improvement and shown to be significant for N = 3 or more. The present design was shown to be capable of generating <1.5 μVrms total recording baseline noise when connected to a FINE placed on the sciatic nerve of an awake animal. An algorithm was introduced to find the value of N that can minimize both the power consumption and the noise in order to design a miniaturized ultralow-noise neural amplifier. Significance. These results demonstrate the efficacy of hardware averaging on noise improvement for neural recording with cuff electrodes, and can accommodate the presence of high source impedances that are associated with the miniaturized contacts and the high channel count in electrode arrays. This technique can be adopted for other applications where miniaturized and implantable multichannel acquisition systems with ultra-low noise and low power are required.

Motion control of the ankle joint with a multiple contact nerve cuff electrode: a simulation study.

The flat interface nerve electrode (FINE) has demonstrated significant capability for fascicular and subfascicular stimulation selectivity. However, due to the inherent complexity of the neuromuscular skeletal systems and nerve-electrode interface, a trajectory tracking motion control algorithm of musculoskeletal systems for functional electrical stimulation using a multiple contact nerve cuff electrode such as FINE has not yet been developed. In our previous study, a control system was developed for multiple-input multiple-output (MIMO) musculoskeletal systems with little prior knowledge of the system. In this study, more realistic computational ankle/subtalar joint model including a finite element model of the sciatic nerve was developed. The control system was tested to control the motion of ankle/subtalar joint angles by modulating the pulse amplitude of each contact of a FINE placed on the sciatic nerve. The simulation results showed that the control strategy based on the separation of steady state and dynamic properties of the system resulted in small output tracking errors for different reference trajectories such as sinusoidal and filtered random signals. The proposed control method also demonstrated robustness against external disturbances and system parameter variations such as muscle fatigue. These simulation results under various circumstances indicate that it is possible to take advantage of multiple contact nerve electrodes with spatial selectivity for the control of limb motion by peripheral nerve stimulation even with limited individual muscle selectivity. This technology could be useful to restore neural function in patients with paralysis.

Different clinical electrodes achieve similar electrical nerve conduction block

Objective. We aim to evaluate the suitability of four electrodes previously used in clinical experiments for peripheral nerve electrical block applications. Approach. We evaluated peripheral nerve electrical block using three such clinical nerve cuff electrodes (the Huntington helix, the Case self-sizing Spiral and the flat interface nerve electrode) and one clinical intramuscular electrode (the Memberg electrode) in five cats. Amplitude thresholds for the block using 12 or 25 kHz voltage-controlled stimulation, onset response, and stimulation thresholds before and after block testing were determined. Main results. Complete nerve block was achieved reliably and the onset response to blocking stimulation was similar for all electrodes. Amplitude thresholds for the block were lowest for the Case Spiral electrode (4 ± 1 Vpp) and lower for the nerve cuff electrodes (7 ± 3 Vpp) than for the intramuscular electrode (26 ± 10 Vpp). A minor elevation in stimulation threshold and reduction in stimulus-evoked urethral pressure was observed during testing, but the effect was temporary and did not vary between electrodes. Significance. Multiple clinical electrodes appear suitable for neuroprostheses using peripheral nerve electrical block. The freedom to choose electrodes based on secondary criteria such as ease of implantation or cost should ease translation of electrical nerve block to clinical practice.

Selective activation of the human tibial and common peroneal nerves with a flat interface nerve electrode

Objective. Electrical stimulation has been shown effective in restoring basic lower extremity motor function in individuals with paralysis. We tested the hypothesis that a flat interface nerve electrode (FINE) placed around the human tibial or common peroneal nerve above the knee can selectively activate each of the most important muscles these nerves innervate for use in a neuroprosthesis to control ankle motion. Approach. During intraoperative trials involving three subjects, an eight-contact FINE was placed around the tibial and/or common peroneal nerve, proximal to the popliteal fossa. The FINE's ability to selectively recruit muscles innervated by these nerves was assessed. Data were used to estimate the potential to restore active plantarflexion or dorsiflexion while balancing inversion and eversion using a biomechanical simulation. Main results. With minimal spillover to non-targets, at least three of the four targets in the tibial nerve, including two of the three muscles constituting the triceps surae, were independently and selectively recruited in all subjects. As acceptable levels of spillover increased, recruitment of the target muscles increased. Selective activation of muscles innervated by the peroneal nerve was more challenging. Significance. Estimated joint moments suggest that plantarflexion sufficient for propulsion during stance phase of gait and dorsiflexion sufficient to prevent foot drop during swing can be achieved, accompanied by a small but tolerable inversion or eversion moment.

Model-based analysis and design of nerve cuff electrodes for restoring bladder function by selective stimulation of the pudendal nerve

Objective. Electrical stimulation of the pudendal nerve (PN) is being developed as a means to restore bladder function in persons with spinal cord injury. A single nerve cuff electrode placed on the proximal PN trunk may enable selective stimulation of distinct fascicles to maintain continence or evoke micturition. The objective of this study was to design a nerve cuff that enabled selective stimulation of the PN. Approach. We evaluated the performance of both flat interface nerve electrode (FINE) cuff and round cuff designs, with a range of FINE cuff heights and number of contacts, as well as multiple contact orientations. This analysis was performed using a computational model, in which the nerve and fascicle cross-sectional positions from five human PN trunks were systematically reshaped within the nerve cuff. These cross-sections were used to create finite element models, with electric potentials calculated and applied to a cable model of a myelinated axon to evaluate stimulation selectivity for different PN targets. Subsequently, the model was coupled to a genetic algorithm (GA) to identify solutions that used multiple contact activation to maximize selectivity and minimize total stimulation voltage. Main results. Simulations did not identify any significant differences in selectivity between FINE and round cuffs, although the latter required smaller stimulation voltages for target activation due to preserved localization of targeted fascicle groups. Further, it was found that a ten contact nerve cuff generated sufficient selectivity for all PN targets, with the degree of selectivity dependent on the relative position of the target within the nerve. The GA identified solutions that increased fitness by 0.7–45.5% over single contact activation by decreasing stimulation of non-targeted fascicles. Significance. This study suggests that using an optimal nerve cuff design and multiple contact activation could enable selective stimulation of the human PN trunk for restoration of bladder function.

Probabilistic modeling of selective stimulation of the human sciatic nerve with a flat interface nerve electrode

Ankle control is critical to both standing balance and efficient walking. The hypothesis presented in this paper is that a Flat Interface Nerve Electrode (FINE) placed around the sciatic nerve with a fixed number of contacts at predetermined locations and without a priori knowledge of the nerve's underlying neuroanatomy can selectively control each ankle motion. Models of the human sciatic nerve surrounded by a FINE of varying size were created and used to calculate the probability of selective activation of axons within any arbitrarily designated, contiguous group of fascicles. Simulations support the hypothesis and suggest that currently available implantable technology cannot selectively recruit each target plantar flexor individually but can restore plantar flexion or dorsiflexion from a site on the sciatic nerve without spillover to antagonists. Successful activation of individual ankle muscles in 90% of the population can be achieved by utilizing bipolar stimulation and/or by using a cuff with at least 20 contacts.

Selective stimulation of the human femoral nerve with a flat interface nerve electrode

In humans, we tested the hypothesis that a flat interface nerve electrode (FINE) placed around the femoral nerve trunk can selectively stimulate each muscle the nerve innervates. In a series of intraoperative trials during routine vascular surgeries, an eight-contact FINE was placed around the femoral nerve between the inguinal ligament and the first nerve branching point. The capability of the FINE to selectively recruit muscles innervated by the femoral nerve was assessed with electromyograms (EMGs) of the twitch responses to electrical stimulation. At least four of the six muscles innervated by the femoral nerve were independently and selectively recruited in all subjects. Of these, at least one muscle was a hip flexor and at least two were knee extensors. Results from the intraoperative experiments were used to estimate the potential for the electrode to restore knee extension and hip flexion through functional electrical stimulation. Normalized EMGs and biomechanical simulations were used to estimate joint moments and functional efficacy. Estimated knee extension moments exceed the threshold required for the sit-to-stand transition.

A Flat Interface Nerve Electrode With Integrated Multiplexer

One of the goals of peripheral nerve cuff electrode development is the design of an electrode capable of selectively activating a specific population of axons in a common nerve trunk. Several designs such as the round spiral electrode or the flat interface nerve electrode (FINE) have shown such ability. However, multiple contact electrodes require many leads, making the implantation difficult and potentially damaging to the nerve. Taking advantage of the flat geometry of the FINE, multiplexers were embedded within the cuff electrode to reduce the number of leads needed to control 32 channels. The circuit was implemented on a polyimide film using off-the-shelf electronic components. The electronic module was surface-mounted directly onto the electrode's flat substrate. Two circuit designs were designed, built, and tested: 1) a single supply design with only two wires but limited to cathodic-first pulse and 2) a dual-supply design requiring three lead wires but an arbitrary stimulation waveform. The electrode design includes 32 contacts in a 1 mm x 8 mm opening. The contact size is 300 microm x 400 microm with access resistance less than 1 k ohm. This electrode is not intended for long-term use, but developed as a feasibility study for future development using low-water-absorption materials such as liquid crystal polymer and an application specific integrated circuit.

A Nerve Cuff Electrode for Controlled Reshaping of Nerve Geometry

The purpose of this study is the development of a nerve electrode that reorganizes nerve geometry slowly and controllably. The Flat Interface Nerve Electrode (FINE) can reshape the nerve into an elongated oval and provide selective stimulation. However, the rate of closure of this electrode is difficult to control. The Slowly Closing - FINE (SC-FINE) is designed with an opening height larger than the size of the nerve to accommodate initial swelling. The electrode closes slowly to reshape the nerve into the desired flat geometry. The SC-FINE is created by combining the reshaping properties of the FINE and the controllable degradation of Poly (DL lactic-co-glycolic) acid (PLGA). Bonding 50/50 or 65/35 PLGA to a stretched FINE increased the opening heights (OH) on average from 0.1 mm to 1.66 +/- 0.45 and 2.05 +/- 0.55 mm respectively. The addition of the PLGA films controls the time course of closure over a period of 16 +/- 1 days and 14 to 16 hours for the 50/50 and 65/35 SC-FINEs respectively in vitro. An in vivo chronic experiment using 50/50 SC-FINEs implanted in 28 rats with an average OH of 1.87 +/- 0.34 mm show that the reshaping periods in vivo and in vitro are similar.