Mechanical fatigue resistance of an implantable branched lead system for a distributed set of longitudinal intrafascicular electrodes.

OBJECTIVE: A neural interface system has been developed that consists of an implantable stimulator/recorder can with a 15-electrode lead that trifurcates into three bundles of five individual wire longitudinal intrafascicular electrodes. This work evaluated the mechanical fatigue resistance of the branched lead and distributed electrode system under conditions designed to mimic anticipated strain profiles that would be observed after implantation in the human upper arm. APPROACH: Custom test setups and procedures were developed to apply linear or angular strain at four critical stress riser points on the lead and electrode system. Each test was performed to evaluate fatigue under a high repetition/low amplitude paradigm designed to test the effects of arm movement on the leads during activities such as walking, or under a low repetition/high amplitude paradigm designed to test the effects of more strenuous upper arm activities. The tests were performed on representative samples of the implantable lead system for human use. The specimens were fabricated using procedures equivalent to those that will be used during production of human-use implants. Electrical and visual inspections of all test specimens were performed before and after the testing procedures to assess lead integrity. MAIN RESULTS: Measurements obtained before and after applying repetitive strain indicated that all test specimens retained electrical continuity and that electrical impedance remained well below pre-specified thresholds for detection of breakage. Visual inspection under a microscope at 10× magnification did not reveal any signs of damage to the wires or silicone sheathing at the stress riser points. SIGNIFICANCE: These results demonstrate that the branched lead of this implantable neural interface system has sufficient mechanical fatigue resistance to withstand strain profiles anticipated when the system is implanted in an arm. The novel test setups and paradigms may be useful in testing other lead systems.

Effects of short-term training on sensory and motor function in severed nerves of long-term human amputees.

Much has been studied and written about plastic changes in the CNS of humans triggered by events such as limb amputation. However, little is known about the extent to which the original pathways retain residual function after peripheral amputation. Our earlier, acute study on long-term amputees indicated that central pathways associated with amputated peripheral nerves retain at least some sensory and motor function. The purpose of the present study was to determine if these functional connections would be strengthened or improved with experience and training over several days time. To do this, electrodes were implanted within fascicles of severed nerves of long-term human amputees to evaluate the changes in electrically evoked sensations and volitional motor neuron activity associated with attempted phantom limb movements. Nerve stimulation consistently resulted in discrete, unitary, graded sensations of touch/pressure and joint-position sense. There was no significant change in the values of stimulation parameters required to produce these sensations over time. Similarly, while the amputees were able to improve volitional control of motor neuron activity, the rate and pattern of change was similar to that seen with practice in normal individuals on motor tasks. We conclude that the central plasticity seen after amputation is most likely primarily due to unmasking, rather than replacement, of existing synaptic connections. These results also have implications for neural control of prosthetic limbs.

Experience with the first three years of an accelerated dual-degree program in biomedical engineering.

Our Department of Bioengineering has instituted a pilot program aimed at helping a select group of highly qualified students obtain both bachelor's and master's degrees in an accelerated timeframe - approximately four years from the beginning of their university studies. A key element of this program is the introduction of the students to research in their second year of studies via a directed and closely supervised cohort mechanism. These students also come to the university with substantial AP credit and spend two summers fulfilling some general education requirements of the university. Our first three years with the program have shown positive results, with most students on track in both academics and research. There have been some challenges, however, with regard to tight scheduling, leaves for religious missions, and continued student stipend funding.

Acoustic detection and communication by decapod crustaceans.

This paper reviews behavioral, physiological, anatomical, and ecological aspects of sound and vibration detection by decapod crustaceans. Our intent is to demonstrate that despite very limited work in this area in the past 20 years, evidence suggests that at least some decapod crustaceans are able to detect and use sounds in ways that parallel detection and processing mechanisms in aquatic and terrestrial vertebrates. Some aquatic decapod crustaceans produce sounds, and many are able to detect substrate vibration at sensitivities sufficient to tell of the proximity of mates, competitors, or predators. Some semi-terrestrial crabs produce and use sounds for communication. These species detect acoustic stimuli as either air- or substrate-borne energies, socially interact in acoustic "choruses," and probably use "calls" to attract mates.

Selective activation of muscle groups in the feline hindlimb through electrical microstimulation of the ventral lumbo-sacral spinal cord.

Selective activation of muscle groups in the feline hindlimb by electrical stimulation of the ventral lumbo-sacral spinal cord was investigated. Spinal cord segments L5 to S1 were mapped using a penetrating tungsten needle electrode. Locations that produced isolated contraction of quadriceps, tibialis anterior or triceps surae/plantaris muscles when stimulated with a current of 40 microA or less, and in which spread of activity to other muscles was not detected after increasing the stimulus to at least twice the threshold level, were defined as belonging to the target muscle's "activation pool." The quadriceps activation pool was found to extend from the beginning of L5 to the middle of L6. The tibialis anterior activation pool extended from the beginning of L6 to the middle of L7, and the triceps surae/plantaris activation pool extended from the caudal end of L6 to the beginning of S1. The three activation pools were located in Rexed motor lamina IX and their spatial organization was found to correspond well with that of the anatomically defined motor pools innervating the same muscles. The spatial and functional segregation of motor pools manifested at the spinal cord level can have direct applications in the areas of functional electrical stimulation and motor control.

Muscle recruitment through electrical stimulation of the lumbo-sacral spinal cord.

The goal of this study was to determine the feasibility of producing graded muscle contraction in individual muscles or muscle groups by electrically stimulating motor neurons in the lumbo-sacral spinal cord. Recruitment curves were obtained for quadriceps, tibialis anterior and triceps surae/plantaris by stimulating their activation pools in the ventral horn of the feline spinal cord. Mean twitch times-to-peak for quadriceps, tibialis anterior and triceps surae/plantaris were 33.0, 41.0, and 36.0 ms, respectively. Twitch duration as a function of stimulus strength demonstrated a mixed motor unit recruitment order, distinctively different from the inverse recruitment order exhibited by conventional methods of electrical stimulation of peripheral nerve. The recruitment curve slopes (expressed as a percentage of maximum force per nanocurrent of delivered charge) were shallow: 7.9 for quadriceps, 2.6 for tibialis anterior and 8.5 for triceps surae/plantaris. These results show that graded control of force in individual muscles or muscle groups can be obtained through spinal cord stimulation, and suggest that spinal cord stimulation could be used for functional neuromuscular stimulation applications.

Recording properties and biocompatibility of chronically implanted polymer-based intrafascicular electrodes.

We implanted polymer-based longitudinal intrafascicular electrodes (polyLIFEs) in feline dorsal rootlets acutely and for periods of two to six months to evaluate their electrical properties and biocompatibility. A total of 38 implanted electrodes were analyzed. Some 25 of the 38 electrodes were implanted with an insulative flexible polymer cuff, which was required for recording of afferent activity in situ. Electrode impedances remained stable for the duration of the experiments. The distributions of axons were measured at three levels of the implanted rootlets: the implant level, 1-2 mm proximal to the implant with respect to the cell body, and 1-2 mm distal to the implant with respect to the cell body. Similar measurements were made in five samples of fascicles neighboring an implant and six samples of control tissue from animals in which no implants were placed. The polyLIFEs demonstrated a high degree of biocompatibility, as no adverse effects on axon size were observed in either the implanted fascicle or neighboring neural tissue. However, the insulative cuffs were found to be a source of compression, resulting in necrosis of the neural tissue.

Proposed specifications for a lumbar spinal cord electrode array for control of lower extremities in paraplegia.

The goal of the study was to provide specifications for a stimulating electrode array to be implanted in the lumbosacral spinal cord as part of a functional neuromuscular stimulation (FNS) system for control of lower extremity muscles in paralyzed individuals. Dual channel stimulation of the quadriceps activation pool in the feline ventral lumbo-sacral spinal cord was performed to measure electrode interactions and to explore the effect of various stimulation paradigms on muscle fatigue. There was no measurable overlap in the populations of motor neurons activated from two different electrodes for spacings > or = 1 mm with currents below 100 microA. However, a statistically significant increase in the population of activated fibers due to current summation was observed when stimuli > or = 70 microA were simultaneously presented through pairs of electrodes within 3 mm of each other. Fatigue effects were studied with three paradigms: 1) stimuli were delivered through a single electrode, 2) stimuli were delivered through two electrodes with the stimulus to the second electrode presented during the refractory period of fibers stimulated by the first electrode, and 3) stimuli were interleaved between the two electrodes such that the stimulus to one electrode was presented midway between stimuli to the other electrode, and the rate of stimulation through a single electrode was half that used in the first two paradigms. Dual channel refractory and single channel stimulation did not differ from each other in the rate at which the muscle fatigued, in both cases the force decayed to 30% of its initial level within 2 min of the initiation of the stimulation regime, whereas the force with interleaved stimulation was still above the initial force at this time due to strong potentiation. Based on these results and on and activation pool dimensions obtained in an earlier study, preliminary specifications are presented for an electrode array to be implanted in the human spinal cord for functional neuromuscular stimulation.

Metallized polymer fibers as leadwires and intrafascicular microelectrodes.

We have developed a process for producing fine, very flexible microwires suitable for use as small signal leadwires or nerve electrodes. The process incorporates metallization of high-performance monofilament polymer fibers to yield electrically conductive fibers with greatly improved flexibility over solid metal wires of similar strength. The metallization layers are produced by serial vacuum deposition of a 0.3 micron thick coating of three metals, titanium-tungsten (Ti/W), gold (Au), and platinum (Pt), onto monofilament, poly-p-phenyl-terephthalate aramid fibers (Kevlar). The metallized fibers are then insulated with an approx. 1 micron thick layer of silicone elastomer. The result is a microlead with high electrical conductivity (linear resistance = 30 omega/cm), desirable interfacial properties, excellent mechanical stability and extremely high flexibility. These physical characteristics are appropriate for application as signal leadwires or recording/stimulating electrodes where small size and high flexibility are paramount. In this paper we report on the electrical and mechanical properties of these metallized fibers and demonstrate their use as intrafascicular electrodes for recording multi-unit neural activity in feline peripheral nerves.

Action potential classification with dual channel intrafascicular electrodes.

Using recordings of peripheral nerve activity made with carbon fiber intrafascicular electrodes, we compared the performance of three different recording techniques (single channel, differential, and dual channel) and four different unit classification methods (linear discriminant analysis, template matching, a novel time amplitude windowing technique, and neural networks) in terms of errors in waveform classification and artifact rejection. Dual channel recording provided uniformly superior unit separability, neural networks gave the lowest classification error rates, and template matching had the best artifact rejection performance.

Analysis of single-unit firing patterns in multi-unit intrafascicular recordings.

A system for extracting single-unit activity patterns from multi-unit neural recordings was tested using real and simulated neural data. The system provided reliable estimates of firing frequency for individual units in simulated multi-unit data and allowed reliable determinations of the responses of individual cutaneous mechanoreceptor units to 'natural' stimuli such as brushing or pressing on the skin. An implementation of the system, which operated online and in real time, was used to obtain estimates of multiple, single-unit responses from multi-unit intrafascicular electrode recordings. The pattern of activity across the population of units in a given recording gave a reliable indication of the type of stimulus that had evoked the activity. It was concluded that this system, used in combination with intrafascicular peripheral nerve recordings, could be used to provide online, real-time information about peripheral stimuli.

Mobility performance with a pixelized vision system.

A visual prosthesis, based on electrical stimulation of the visual cortex, has been suggested as a means for partially restoring functional vision in the blind. The prosthesis would create a pixelized visual sense consisting of punctate spots of light (phosphenes). The present study investigated the feasibility of achieving visually-guided mobility with such a visual sense. Psychophysical experiments were conducted on normally sighted human subjects, who were required to walk through a maze which included a series of obstacles, while their visual input was restricted to information from a pixelized vision simulator. Walking speed and number of body contacts with obstacles and walls were measured as a function of pixel number, pixel spacing, object minification, and field of view. The results indicate that a 25 x 25 array of pixels distributed within the foveal visual area could provide useful visually guided mobility in environments not requiring a high degree of pattern recognition.

Reading speed with a pixelized vision system.

A visual prosthesis based on electrical stimulation of the visual cortex with an array of penetrating electrodes is expected to produce pixelized visual images consisting of punctate spots of light (phosphenes). We measured reading speed in subjects viewing text with optically simulated phosphene fields in order to obtain estimates of the following design parameters for such an electrode array: pixel number, pixel spacing, and visual-field size. Comparisons were made between scanning the text with eye movements and scanning the text with head movements. The results indicate that a 25 x 25 array of pixels representing four letters of text projected on a foveal visual field of 1.7 degrees is sufficient to provide reading rates near 170 words/min with scrolled text and near 100 words/min with fixed text.

Separation of action potentials in multiunit intrafascicular recordings.

Classification of action potentials in multiunit recordings was based on the use of various types of features to uniquely characterize action potentials from different cells. We compared classification results obtained using three types of descriptive features: digitized data points, amplitude and duration (time domain) parameters, and fast Fourier transform (FFT) coefficients. Digitized data points used as descriptive features provided good classification success and required minimal computation. Time-domain features gave comparable results but required more computation. FFT coefficients were less effective than the other features. As the signal-to-noise ratio of the recordings increased, smaller differences in feature values could be discriminated.

Information contained in sensory nerve recordings made with intrafascicular electrodes.

Multiunit recordings were made in anesthetized cats with chronically implanted intrafascicular electrodes over a period of six months. Neural signals recorded with these electrodes consisted of activity in sensory fibers innervating a variety of cutaneous mechanoreceptors. Mechanical stimuli were used to selectively activate individual nerve fibers, and the receptive field and receptor type were identified for each unit. Over a period of six months, there was a net shift in the recorded population, but the electrodes continued to provide a representative sample of the activity in the fascicle as a whole. The total number of units from which activity could be recorded remained roughly constant with time, and individual units persisted in the recordings for up to six months. These results indicate that intrafascicular electrodes could be used to sample information carried by individual somatosensory fibers on a long term basis.

A silicon-based, three-dimensional neural interface: manufacturing processes for an intracortical electrode array.

A method has been developed for the manufacture of a "three-dimensional" electrode array geometry for chronic intracortical stimulation. This silicon based array consists of a 4.2 x 4.2 x 0.12 mm thick monocrystalline substrate, from which project 100 conductive, silicon needles sharpened to facilitate cortical penetration. Each needle is electrically isolated from the other needles, and is about 0.09 mm thick at its base and 1.5 mm long. The sharpened end of each needle is coated with platinum to facilitate charge transfer into neural tissue. The following manufacturing processes were used to create this array. 1) Thermomigration of 100 aluminum pads through an n-type silicon block. This creates trails of highly conductive p+ silicon isolated from each other by opposing pn junctions. 2) A combination of mechanical and chemical micromachining which creates individual penetrating needles of the p+ silicon trails. 3) Metal deposition to create active electrode areas and electrical contact pads. 4) Array encapsulation with polyimide. The geometrical, mechanical, and electrical properties of these arrays should make them well suited as interfaces to cortical tissue.

A chronic intracortical electrode array: preliminary results.

Two sets of electrode arrays made of either 25- or 50-microns-diameter Teflon-insulated platinum-iridium wire and Teflon have been developed for chronic intracortical electrical stimulation. Cortical histological studies were performed following acute and chronic implantation in cats. While some neural damage resulted from the implantations of either array configuration, a unique set of problems was associated with each diameter wire. Arrays with 50-microns electrodes and lead wires tended to maintain interelectrode spacing upon implantation, but the percutaneous leads retained residual stress which made array implantation difficult. Arrays with 25-microns electrodes and lead wires suffered from changes in interelectrode spacing upon implantation, but were much easier to manipulate during surgery. Both array configurations demonstrated some movement after implantation. It is concluded that a chronic intracortical stimulating electrode array of this geometry should have the following properties: 1) the penetrating electrodes and supporting substrate must be stiff (to maintain interelectrode spacings upon implantation), and 2) the percutaneous leads must be extremely flexible (to avoid array movement after implantation).

An intrafascicular electrode for recording of action potentials in peripheral nerves.

We are developing a new type of bipolar recording electrode intended for implantation within individual fascicles of mammalian peripheral nerves. In the experiments reported here we used electrodes fabricated from 25 microns diameter Pt wire, 50 microns 90% Pt-10% Ir wire and 7 microns carbon fibers. The electrodes were implanted in the sciatic nerves of rats and in the ulnar nerves of cats. The signal-to-noise ratio of recorded activity induced by nonnoxious mechanical stimulation of the skin and joints was studied as a function of the type of electrode material used, the amount of insulation removed from the recording zone, and the longitudinal separation of the recording zones of bipolar electrode pairs. Both acute and short term (two day) chronic experiments were performed. The results indicate that a bipolar electrode made from Teflon-insulated, 25 microns diameter, 90% Pt-10% Ir wire, having a 1-2 mm long recording zone, can be used for recording of peripheral nerve activity when implanted with one wire inside the fascicle and the other lead level with the first lead, but outside the fascicle. No insulating cuff needs to be placed around the nerve trunk.