Journal of Medical and Biological Engineering, 31(5): 353-357 353 Self-closing Cuff Electrode for Functional Neural Stimulation and Recording Naga S. Korivi Pratul K. Ajmera* Electronic Material & Device Laboratory, Department of Electrical & Computer Engineering, Louisiana State University, LA 70803, USA Received 6 Aug 2010; Accepted 6 Dec 2010; doi: 10.5405/jmbe.819 Abstract This paper reports on a novel cuff electrode design for applications in neural electrical stimulation and recording. One of the more commonly employed electrode designs for the functional electrical stimulation of nerves and nerve fibers is the cylindrical cuff electrode, which has a lengthwise opening that allows placement of the target nerve within the cuff. The cuff opening is subsequently closed to secure the cuff and to decrease electrical noise from the surrounding ambient. These additional intra-operative steps required for cuff closure are a major limitation of most of the current cuff electrode designs. Some cuff electrode designs specifically proposed to address this cuff closure issue suffer from other inherent drawbacks. Therefore, there is a need for an electrode design that can preserve the advantages of a cuff structure, while overcoming the cuff closure problem. The cuff electrode design proposed here addresses the problem of securing the cuff opening after placement on the target nerve tissue. The proposed design consists of a normally closed cuff that has a pinch hinge. By applying a small force on the arms of the pinch hinge, the cuff can be opened for placement on a nerve. Subsequent removal of the force returns the cuff to its closed state. This self-closing cuff design is expected to enhance the ease of implanting cuff electrodes on nerves for functional electrical stimulation and recording applications. Keywords: Functional electrical stimulation (FES), Nerve stimulation, Cuff electrode, Neural signal recording 1. Introduction The functional electrical stimulation (FES) of nerves and nerve fibers is of interest in the control and treatment of numerous physiological conditions [1]. Cuff electrodes offer several advantages compared to other commonly used electrodes, such as hook electrodes or wire-wound electrodes, for the FES of nerves and nerve fibers. The advantages include a reduction in the stimulus intensity required for n erve activation, minimization of the mechanical distortion of the nerve, reduced probability of lead failure, and selective stimulation of the target tissue [2,3]. A typical cuff electrode has a lengthwise opening that requires closing upon placement on the target nerve to ensure that the electrode stays secured and in contact with the target nerve. In addition, in applications involving bio-potential recording, a closed cuff electrode reduces electrical noise from the surrounding physiological ambient [4]. During implantation, conventional cuff electrodes are manually opened, placed on the target nerve, and closed. The cuff opening is typically secured by epoxy, wax, small * Corresponding author: Pratul K. Ajmera Tel: +1-225-5785620; Fax: +1-225-5785200 E-mail: ajmera@lsu.edu pieces of silicone rubber, or suture thread [5-7], all of which require intra-operative procedures. These additional intra-operative procedures may become significantly more complicated when the cuff electrodes have small dimensions, such as those required for small-diameter nerves and nerve fibers. The spiral cuff design addresses the cuff closure problem, but some spiral cuffs do not reliably interface with small nerves [8]. Therefore, there is a need for an electrode design that preserves the advantages of a conventional cuff structure while overcoming the cuff closure problem. 2. Methods and materials A self-closing cuff electrode design (Fig. 1) is proposed here to address the cuff closure problem. The proposed device incorporates metal wire or foil electrodes in the inner diameter of a polymeric cuff. The cuff is normally closed. A pinch-hinge-type structure in the cuff electrode allows the user to conveniently open and close the cuff to enclose the target tissue [9]. Once implanted, the cuff stays on the nerve until the pinch hinge is used to open it. A flat sheet of acrylic was cleaned with de-ionized (DI) water and air dried for use as a base substrate. A layer of polyvinyl alcohol (PVA) was spin-coated onto the substrate to function as a mold release layer (Fig. 2A). An aqueous solution 354 J. Med. Biol. Eng., Vol. 31 No. 5 2011 of PVA (1:8 PVA to DI water ratio, by weight) was used for this purpose. After spin-coating, the mold release layer was allowed to solidify at room temperature for 8 h. release coating on the wire, allowing for the wire to be easily pulled out from the silicone (Fig. 2F). The free-standing cured silicone structure with a hollow cylinder was manually trimmed at the sides using a blade to the desired lateral dimensions of the cuff. One side of the structure was manually cut to remove some silicone material to form a pinch hinge (Fig. 2G). On the other side of the structure, the edges were trimmed (Fig. 2H) to reduce the overall size and mass of the device. The cuff opening was then defined by manually making a slit on the cured structure (Fig. 2I). Figure 1. Schematic representation of the proposed cuff electrode with its normally closed cuff. Figure 3. Schematic of attaching electrical leads to the cuff body. Figures are not drawn to scale. Figure 2. Schematic of the fabrication process for the cuff body. Figures are not drawn to scale. A thin layer of medical-grade silicone (Silastic® MDX4-4210 elastomer kit) was spin-coated onto the solid mold release layer (Fig. 2B). This layer was cured in a convection oven at 60°C for 3 h. A metal wire of a known diameter was then dip-coated with a thin layer of PVA (Fig. 2C). The wet PVA layer was allowed to solidify at room temperature for 8 h. The coated metal wire was placed in conformal contact with the silicone layer on the substrate (Fig. 2D). A thick layer of uncured silicone liquid was poured over the wire and cured thermally at 60°C for 3 h (Fig. 2E). As this thicker layer cured, it bonded permanently with the underlying thin silicone layer. Subsequently, the cured silicone structure was released from the substrate by dissolving the mold release coating on the substrate in an ultrasonic bath of water. Further ultrasonic treatment in a bath of water dissolved the mold At this stage of the fabrication process, the main body of the device is obtained, with the cuff structure in a normally closed position. Depressing the pinch hinge allows the cuff to be opened. To complete the cuff electrode device, electrodes need to be incorporated in the cuff. A segment of multi-strand stainless steel electrode wire with Teflon insulation was stripped of its Teflon coating at one end to expose a length of bare wire. This bare strand of wire, 50 µm in diameter, functions as an electrode lead inside the cylindrical space of the cuff. The cuff body (Fig. 3A) can be opened slightly by holding the arms of the pinch hinge and applying a squeezing force (Fig. 3B). A 26½ gauge syringe needle was employed to pierce the cuff body from the pinch hinge side (Fig. 3C). The needle was allowed to exit from the cuff side, through the open cuff. The insulated end of the electrode wire was inserted into the needle from the cuff side (Fig. 3D). When the wire appeared at the other side of the needle, it was held by tweezers and gently pulled through until a few cm of the wire projected out (Fig. 3E). At this juncture, the syringe needle was disengaged from the cuff body by holding the electrode wire at the cuff opening side and by gently pulling out the needle with a twisting motion, leaving the wire inside the cuff body (Fig. 3F). As the needle was pulled out, the cuff body material collapsed around the wire, holding it snugly. The wire was then pulled further from the pinch hinge side until only the bare wire was Self-closing Cuff Electrode for Nerve Tissue inside the cylindrical opening (Fig. 3G). The entire process was repeated to introduce the desired number of electrode leads (Fig. 3H). For the case considered here, three electrode leads were inserted into the open space of the cuff cylinder (Fig. 3H). The cuff was then opened to enclose a pin that was rotated to bend the electrode leads. This operation shaped the electrode leads, making them lie against the inner wall of the cuff (Fig. 3I). Subsequently, the electrode wire-cuff body interface at the point of exit of each electrode wire was reinforced with silicone (Fig. 3J). 3. Results and disscussion The proposed electrode device was fabricated with cuff inner diameters of approximately 400 µm and 800 µm (Fig. 4A), respectively, with bare metal wires incorporated inside the cuff and insulated portions of the wires exiting from the cuff body. The exit point of the wires was reinforced by applying liquid silicone pre-polymer and curing it thermally (Fig. 4B). Figure 4. Microscope images of self-closing cuff electrode. The scale ruler has 0.397 mm spacing markers. The same type of silicone material was used for the device body and for the wire reinforcement to form a robust interface between the cuff body and electrical wiring. Although three electrode wires were incorporated into the fabricated devices, a larger number of electrodes can be installed if desired. The metal wire electrodes of the self-closing cuff are not fixed inside the device. They lie flush against the inner walls of the cuff. Other studies that employed this metal wire arrangement inside a cuff did not report interference with the insertion of a nerve [10]. The metal wires can be fixed during the fabrication process if desired. The total weight of the developed cuff device including the electrode wires (Fig. 4) is in the range of 0.2~0.3 g with total outer surface area in the range of 45~60 mm2. The cuff inner diameter can be made to be over 2.5 mm. The developed electrodes were subjected to electrical and mechanical tests. The electrical impedance between the leads was measured in 2 M potassium chloride (KCl) solution at room temperature with an impedance meter (Tenma® dual-display LCR meter, model 72-960). The electrical impedance between the electrode leads was found to be in a range of 300 Ω to 3 kΩ. This is close to the range of values reported in the literature for other cuff devices [11]. The impedance values indicate that the electrode leads inside the cuff function properly. 355 In another test, electrical signals in the micro-volt range at a given frequency were fed to the electrodes of the self-closing cuff (Fig. 5A). Resistor R2 was connected between electrodes E1 and E2 to simulate an enclosed nerve. The electrical resistance of a nerve trunk with a diameter of 1.06 mm is approximately 28.75 kΩ/cm [12]. Due to a spacing of 2 mm between the electrodes, the value of R2 was chosen to be 5.6 kΩ to simulate a 2-mm-long nerve trunk enclosed between the electrodes. The signals read by the electrodes were recorded after being amplified. A recorded sinusoidal wave voltage signal at 1 kHz with an amplitude of approximately 150 µV, amplified by a gain of 91, is shown in Fig. 5. Signals with amplitudes of as low as 75 µV in a frequency range of 100 Hz~5 kHz were successfully read by the proposed self-closing cuff. These signals are in the range of typical electroneurogram (ENG) signals in terms of magnitude and frequency. Figure 5. (A) Schematic of in vitro testing of the self-closing electrode to study its applicability in stimulation and recording. Digital oscilloscope data of real-time recording of (B) an artificially generated voltage signal Vin input to the electrodes of the self-closing cuff through a R2/(R1+R2) voltage divider and (C) an amplified signal read by the electrodes of the cuff. The signal inversion is due to the use of an amplifier in the final stage of the test set-up. No filtering component or equipment was employed for removing electrical noise. The self-closing cuff electrodes were evaluated for their applicability in bio-potential recording. The cuff device was immersed in stationary KCl solution and the electrical impedance between its electrode leads was measured (Table 1). The KCl solution was then agitated by a magnetic stir bar to simulate the effects of a physiological ambient in motion. The impedance readings showed considerable, random fluctuations ranging between 2.5 kΩ~14 kΩ for a 120-Hz measurement, as shown in Table 1. The two circular openings at the lateral ends of the self-closing cuff were closed by attaching pieces of silicone. The cuff electrode was then reintroduced into the KCl solution. The KCl solution entered the cuff gradually and filled the cuff interior. The electrical impedance readings were obtained and found to be in the range of those measured in stationary KCl solution, with the cuff ends open. The solution was then agitated by magnetic stirring. The impedance readings did not show appreciable changes due to the movement of the solution, ranging between 2.2 kΩ~3 kΩ for a 120-Hz measurement. Subsequently, the cuff endings were opened by 356 J. Med. Biol. Eng., Vol. 31 No. 5 2011 removing the silicone pieces and the electrical impedance was measured in agitated KCl solution. The impedance values were found to fluctuate considerably. These results are attributed to the more or less fixed enclosed volume inside the cuff when it is in the closed position, a situation analogous to when the cuff encloses a nerve. Therefore, the proposed device can be used for recording electrical signals with a high signal to noise ratio from a nerve tissue. For conventional cuff electrodes, a similar signal to noise ratio may be obtained if the cuff is closed by epoxy, wax, or silicone pieces. However, these sealing procedures are intra-operative. If a suture thread is used to close a conventional cuff, the electrical noise from the surrounding ambient may not be reduced to the extent possible by the self-closing cuff. The overall size of the self-closing cuffs can be reduced without any change in the fabrication process. Experiments show that the cuff size can be decreased to reduce the total surface area by more than 30% of the value on devices reported here. A further reduction in size is possible. The control of pressure on the nerve is important for the safety of nerve tissue. Previous experimental studies on the circular compression of rabbit sciatic nerves determined that blood perfusion of the nerves started decreasing at a mean pressure of 4066.3 Pa [14]. Our theoretical modeling indicates that thinner cuff walls can accommodate the expansion of an enclosed nerve with minimal or no compression. Therefore, future work will focus on reducing the overall size of the cuff, including the cuff wall thickness. Table 1. Electrical impedance readings for proposed self-closing cuff electrode measured between its electrode leads in stationary and moving KCl ambient, with the cuff’s lateral ends closed and open, respectively. 4. Conclusion Cuff condition Lateral ends open Lateral ends open Lateral ends closed KCl ambient condition Stationary Moving Moving Impedance reading at 120 Hz 2.3 kΩ~3.2 kΩ 2.5 kΩ~14 kΩ 2.2 kΩ~3 kΩ A major goal of the present research is to secure a cuff electrode to a target tissue without requiring additional steps during surgery. Force tests performed on the developed cuff device indicate the efficacy of this normally closed cuff design. A metal pin was enclosed in the cuff and the cuff was returned to its closed state. The enclosed metal pin was clamped at both its ends. The electrical wires exiting the cuff were attached to the hook of a force gauge (Chatillon, NY, USA, Gauge-R, Model 516-1000) and a pulling force was applied to the wires. During the course of testing, the enclosed metal pin did not bend from the force applied. The force was progressively increased until the cuff was removed from the enclosed wire. The force-test results indicate that the developed self-closing cuff device can withstand a force of 1.9 N before the enclosed pin is removed. This compares favorably to a force of 0.2 N measured for a conventional cylindrical cuff device fabricated using the processes typically used for such devices [10]. For both types of device tested, the outer surface areas and total weights of the devices were comparable. For the self-closing cuff device developed in this work with a total outer surface area of 45~60 mm2 and a weight of 0.2~0.3 g, an average force of 0.8 ± 5% N is required to open the cuff to its maximum extent. This relatively low required opening force indicates that the self-closing cuff design is an alternative to designs that require the application of a force for cuff closure. For example, Durand et al. reported a cuff design with male-female interlocking structures that requires the application of a 2-N force to achieve cuff closure [13]. This magnitude of force can harm the nerve if the cuff is improperly closed. Durability testing of the pinch hinge of the developed cuff electrode indicates that the cuff can withstand more than 50 open-close operations, which is significantly more than needed during a typical lifetime of such a device. A pinch hinge was incorporated in a self-closing cuff electrode to allow the user to easily open the cuff and place it on the target nerve tissue for stimulation or recording purposes. When the pinch hinge is released by the user, the cuff assumes its normally closed position. The pinch hinge negates the need to close the cuff electrode by suture threads or some other intra-operative procedure. The proposed self-closing cuff electrode offers researchers an easy means to stimulate or record electrical signals from nerves and nerve fibers with effective diameters ranging from the micro-scale to the millimeter-scale. Acknowledgement The authors acknowledge the assistance of Mr. Golden Hwaung in the laboratory. References [1] [2] [3] [4] [5] [6] [7] B. Smith, Z. Tang, M. W. Johnson, S. Pourmehdi, M. M. Gazdik, J. R. Buckett and P. H. Peckham, “An externally powered multichannel implantable stimulator telemeter for control of paralyzed muscle,” IEEE Trans. Biomed. Eng., 45: 463-475, 1998. F. J. Rodriguez, D. Ceballos, M. Schuttler, A. Valero, E. Valderrama, T. Stieglitz and X. Navarro, “Polyimide cuff electrodes for peripheral nerve stimulation,” J. Neurosci. Meth., 98: 105-118, 2000. C. Veraart, W. M. Grill and J. T. Mortimer, “Selective control of muscle activation with a multipolar nerve cuff electrode,” IEEE Trans. Biomed. Eng., 40: 640-653, 1993. R. B. Stein, T. R. Nichols, J. Jhamandas, L. Davis and D. Charles, “Stable long-term recordings from cat peripheral nerves,” Brain Res., 128: 21-38, 1977. V. Fenik, P. Fenik and L. Kubin, “A simple cuff electrode for nerve recording and stimulation in acute experiments on small animals,” J. Neurosci. Meth., 106: 147-151, 2001. T. Jellema and J. L. J. M. Teepen, “A miniaturized cuff electrode for electrical stimulation of peripheral nerves in the freely moving rat,” Brain Res. Bull., 37: 551-554, 1995. J. S. Carp, A. M. Tennissen, X. Y. Chen, G. Schalk and J. R. Wolpaw, “Long-term spinal reflex studies in awake behaving mice,” J. Neurosci. Meth., 149: 134-143, 2005. Self-closing Cuff Electrode for Nerve Tissue J. J. Mrva, J. Coburn, R. B. Strother and G. B. Thrope, “Devices, systems, and methods employing a molded nerve cuff electrode,” U.S. Patent No. 2006/0030919 A1, 2006. [9] N. S. Korivi and P. K. Ajmera, “Implantable clip-on micro-cuff electrode for functional stimulation and bio-potential recording,” U.S. Patent Application Publication 0168831, 2010. [10] J. F. Sauter, H. R. Berthoud and B. Jeanrenaud, “A simple electrode for intact nerve stimulation and/or recording in semi-chronic rats,” Pflugers Arch., 397: 68-69, 1983. [11] C. Donfack, M. Sawan and Y. Savaria, “Implantable measurement technique dedicated to the monitoring of [8] 357 electrode-nerve contact in bladder stimulators,” Med. Biol. Eng. Comput., 38: 465-468, 2000. [12] K. W. Altman and R. Plonsey, “Analysis of the longitudinal and radial resistivity measurements of the nerve trunk,” Ann. Biomed. Eng., 17: 313-324, 1989. [13] D. M. Durand, D. Tyler and B. Cottrill, “Nerve cuff for implantable electrode,” U.S. Patent Application Publication 0046055, 2008. [14] M. S. Ju, C. C. K. Lin, J. L. Fan and R. J. Chen, “Transverse elasticity and blood perfusion of sciatic nerves under in situ circular compression,” J. Biomech., 39: 97-102, 2006. 358 J. Med. Biol. Eng., Vol. 31 No. 5 2011
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