We have used finite-element (FE) modeling to investigate the mechanical compliance, positional stability and contact pressures associated with a novel type of spinal cord stimulator that is placed directly on the pial surface of the spinal cord in order to more selectively activate neural structures for relief of intractable pain. The properties used in the model are those of the actual prototype devices employed in recent in vitro and chronic in vivo tests. The agreement between predictions and experimental observations serves to validate our FE approach, which can now be used to further optimize the device's design and performance.
Issue Section:
Research Papers
References
1.
Howard
, M. A.
, III, Utz
, M.
, Brennan
, T. J.
, Dalm
, B. D.
, Viljoen
, S.
, Jeffery
, N. D.
, and Gillies
, G. T.
, 2011
, “Intradural Approach to Selective Stimulation in the Spinal Cord for Treatment of Intractable Pain: Design Principles and Wireless Protocol
,” J. Appl. Phys.
, 110
(4
), p. 044702
.10.1063/1.36264692.
North
, R. B.
, 2008
, “Neural Interface Devices: Spinal Cord Stimulation Technology
,” Proc. IEEE
, 96
(7
), pp. 1108
–1119
.10.1109/JPROC.2008.9225583.
Atkinson
, L.
, Sundaraj
, S. R.
, Brooker
, C.
, O'Callaghan
, J.
, Teddy
, P.
, Salmon
, J.
, Semple
, T.
, and Majedi
, P. M.
, 2011
, “Recommendations for Patient Selection in Spinal Cord Stimulation
,” J. Clin. Neurosci.
, 18
(10
), pp. 1295
–1302
.10.1016/j.jocn.2011.02.0254.
Flouty
, O. E.
, Oya
, H.
, Kawasaki
, H.
, Wilson
, S.
, Reddy
, C. G.
, Jeffery
, N. D.
, Brennan
, T. J.
, Gibson-Corley
, K. N.
, Utz
, M.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2012
, “A New Device Concept for Directly Modulating Spinal Cord Pathways: Initial In Vivo Experimental Results
,” Physiol. Meas.
, 33
(12
), pp. 2003
–2015
.10.1088/0967-3334/33/12/20035.
Struijk
, J. J.
, Holsheimer
, J.
, van Veen
, B. K.
, and Boom
, H. B. K.
, 1991
, “Epidural Spinal Cord Stimulation: Calculation of Field Potentials With Special Reference to Dorsal Column Nerve Fibers
,” IEEE Trans. Biomed. Eng.
, 38
(1
), pp. 104
–110
.10.1109/10.682176.
Holsheimer
, J.
, Barolat
, G.
, Struijk
, J. J.
, and He
, J.
, 1995
, “Significance of the Spinal Cord Position in Spinal Cord Stimulation
,” Acat Neurochir. Suppl., 64
, pp. 119
–124
.10.1007/978-3-7091-9419-57.
Holsheimer
, J.
, and Wesselink
, W. A.
, 1997
, “Optimum Electrode Geometry for Spinal Cord Stimulation: The Narrow Bipole and Tripole
,” Med. Biol. Eng. Comput.
, 35
(5
), pp. 493
–497
.10.1007/BF025255298.
Feirabend
, H. K. P.
, Choufoer
, H.
, Ploeger
, S.
, Holsheimer
, J.
, and van Gool
, J. D.
, 2002
, “Morphometry of Human Superficial Dorsal and Dorsolateral Column Fibres: Significance to Spinal Cord Stimulation
,” Brain
, 125
(5
), pp. 1137
–1149
.10.1093/brain/awf1119.
Gharibo
, C.
, Laux
, G.
, Forzani
, B. R.
, Sellars
, C.
, Kim
, E.
, and Zou
, S.
, 2014
, “State of the Field Survey: Spinal Cord Stimulator Use by Academic Pain Medicine Practices
,” Pain Med.
, 15
(2
), pp. 188
–195
.10.1111/pme.1226410.
Holsheimer
, J.
, 2002
, “Which Neuronal Elements are Activated Directly by Spinal Cord Stimulation
,” Neuromodulation
, 5
(1
), pp. 25
–31
.10.1046/j.1525-1403.2002._2005.x11.
Kupers
, R. C.
, Van den Oever
, R.
, Van Houdenhove
, B.
, Vanmechelen
, W.
, Hepp
, B.
, Nuttin
, B.
, and Gybels
, J. M.
, 1994
, “Spinal Cord Stimulation in Belgium: A Nation-Wide Survey on the Incidence, Indications and Therapeutic Efficacy by the Health Insurer
,” Pain
, 56
(2
), pp. 211
–216
.10.1016/0304-3959(94)90096-512.
Cameron
, T.
, 2004
, “Safety and Efficacy of Spinal Cord Stimulation for the Treatment of Chronic Pain: A 20-Year Literature Review
,” J. Neurosurg. (Spine)
, 100
(3
), pp. 254
–267
.10.3171/spi.2004.100.3.025413.
North
, R. B.
, Kidd
, D. H.
, Olin
, J.
, Sieracki
, J. M.
, Farrokhi
, F.
, Petrucci
, L.
, and Cutchis
, P. N.
, 2005
, “Spinal Cord Stimulation for Axial Low Back Pain—A Prospective, Controlled Trial Comparing Dual With Single Percutaneous Electrodes
,” Spine
, 30
(12
), pp. 1412
–1418
.10.1097/01.brs.0000166502.05449.a814.
Taylor
, R. S.
, Van Buyten
, J.-P.
, and Buchser
, E.
, 2005
, “Spinal Cord Stimulation for Chronic Back and Leg Pain and Failed Back Surgery Syndrome: A Systematic Review and Analysis of Prognostic Factors
,” Spine
, 30
(1
), pp. 152
–160
.10.1097/01.brs.0000152115.79236.6e15.
Kumar
, K.
, Taylor
, R. S.
, Jacques
, L.
, Eldabe
, S.
, Meglio
, M.
, Molet
, J.
, Thomson
, S.
, O'Callaghan
, J.
, Eisenberg
, E.
, Milbouw
, G.
, Buchser
, E.
, Fortini
, G.
, Richardson
, J.
, and North
, R. B.
, 2007
, “Spinal Cord Stimulation Versus Conventional Medical Management for Neuropathic Pain: A Multicentre Randomised Controlled Trial in Patients With Failed Back Surgery Syndrome
,” Pain
, 132
(1–2
), pp. 179
–188
.10.1016/j.pain.2007.07.02816.
Eldabe
, S.
, Kumar
, K.
, Buchser
, E.
, and Taylor
, R. S.
, 2010
, “An Analysis of the Components of Pain, Function, and Health-Related Quality of Life in Patients With Failed Back Surgery Syndrome Treated With Spinal Cord Stimulation or Conventional Medical Management
,” Neuromodulation
, 13
(3
), pp. 201
–209
.10.1111/j.1525-1403.2009.00271.x17.
Huang
, Q.
, Oya
, H.
, Flouty
, O. E.
, Reddy
, C. G.
, Howard
, M. A.
, III, Gillies
, G. T.
, and Utz
, M.
, 2014
“Comparison of Spinal Cord Stimulation Profiles From Intradural and Extradural Electrode Arrangements by Finite Element Modeling
,” Med. Biol. Eng. Comput.
, 52
(6
), pp. 531
–538
.10.1007/s11517-014-1157-718.
Flouty
, O. E.
, Oya
, H.
, Kawasaki
, H.
, Reddy
, C. G.
, Fredericks
, D. C.
, Gibson-Corley
, K. N.
, Jeffery
, N. D.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2013
, “Intracranial Somatosensory Responses With Direct Spinal Cord Stimulation in Anesthetized Sheep
,” PLoS One
, 8
(2
), p. e56266
.10.1371/journal.pone.005626619.
Viljoen
, S.
, Dalm
, B. D.
, Reddy
, C. G.
, Wilson
, S.
, Smittkamp
, C.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2013
, “Optimization of Intradural Spinal Cord Stimulator Designs Via Analysis of Thoracic Spine Imaging Data
,” J. Med. Biol. Eng.
, 33
(2
), pp. 193
–198
.10.5405/jmbe.131720.
Viljoen
, S.
, Smittkamp
, C. A.
, Dalm
, B. D.
, Wilson
, S.
, Reddy
, C. G.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2014
, “MR-Based Measurement of Spinal Cord Motion During Flexion of the Spine: Implications for Intradural Spinal Cord Stimulator Systems
,” J. Med. Eng. Technol.
, 38
(1
), pp. 1
–4
.10.3109/03091902.2013.84420721.
Gibson-Corley
, K. N.
, Oya
, H.
, Flouty
, O.
, Fredericks
, D. C.
, Jeffery
, N. D.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2012
, “Ovine Tests of a Novel Spinal Cord Neuromodulator and Dentate Ligament Fixation Method
,” J. Invest. Surg.
, 25
(6
), pp. 366
–374
.10.3109/08941939.2012.67796722.
Oya
, H.
, Safayi
, S.
, Jeffery
, N. D.
, Viljoen
, S.
, Reddy
, C. G.
, Dalm
, B. D.
, Kanwal
, J. K.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2013
, “Soft-Coupling Suspension System for an Intradural Spinal Cord Stimulator: Biophysical Performance Characteristics
,” J. Appl. Phys.
, 114
(16
), p. 164701
.10.1063/1.482719523.
Grosland
, N.
, Shivanna
, K. H.
, Magnotta
, V. A.
, Kallemeyn
, N.
, DeVries
, N. A.
, Tadepalli
, S. C.
, and Lislee
, C.
, 2009
, “IA-FEMesh: An Open-Source, Interactive, Multiblock Approach to Anatomic Finite Element Model Development
,” Comput. Methods Programs Biomed.
, 94
(1
), pp. 96
–107
.10.1016/j.cmpb.2008.12.00324.
Howard
, M. A.
, III, Utz
, M.
, Brennan
, T. J.
, Dalm
, B. D.
, Viljoen
, S.
, Kanwal
, J. K.
, and Gillies
, G. T.
, 2011
, “Biophysical Attributes of an In Vitro Spinal Cord Surrogate for Use in Developing an Intradural Neuromodulation System
,” J. Appl. Phys.
, 110
(7
), p. 074701
.10.1063/1.364297625.
Viljoen
, S.
, Oya
, H.
, Reddy
, C. G.
, Dalm
, B. D.
, Shurig
, R.
, Odden
, K.
, Gillies
, G. T.
, and Howard
, M. A.
, III, 2013
, “Apparatus for Simulating Dynamic Interactions Between the Spinal Cord and Soft-Coupled Intradural Implants
,” Rev. Sci. Instrum.
, 84
(11
), p. 114303
.10.1063/1.483180126.
Fort Wayne Metals
, 2014
, “Specifications: MP35N Superalloy
,” Fort Wayne Metals, Fort Wayne, IN, http://www.fwmetals.com/mp35n-superalloy.php27.
Coburn
, B.
, and Sin
, W. K.
, 1985
, “A Theoretical Study of Epidural Electrical Stimulation of the Spinal Cord—Part I: Finite Element Analysis of Stimulus Fields
,” IEEE Trans. Biomed. Eng.
, 32
(11
), pp. 91
–977
.10.1109/TBME.1985.32564828.
Holsheimer
, J.
, 1998
, “Computer Modelling of Spinal Cord Stimulation and Its Contribution to Therapeutic Efficacy
,” Spinal Cord
, 36
(8
), pp. 531
–540
.10.1038/sj.sc.310071729.
Hernández-Labrado
, G. R.
, Polo
, J. L.
, López-Dolado
, E.
, and Collazos-Castro
, J. E.
, 2011
, “Spinal Cord Direct Current Stimulation: Finite Element Analysis of the Electric Field and Current Density
,” Med. Biol. Eng. Comput.
, 49
(4
), pp. 417
–429
.10.1007/s11517-011-0756-930.
Sankarasubramanian
, V.
, Buitenweg
, J. R.
, Holsheimer
, J.
, and Veltink
, P.
, 2011
, “Triple Leads Programmed to Perform as Longitudinal Guarded Cathodes in Spinal Cord Stimulation: A Modeling Study
,” Neuromodulation
, 14
(5
), pp. 401
–410
.10.1111/j.1525-1403.2011.00383.x31.
Rosenow
, J. M.
, Stanton-Hicks
, M.
, Rezai
, A. R.
, and Henderson
, J. M.
, 2006
, “Failure Modes of Spinal Cord Stimulator Hardware
,” J. Neurosurg.—Spine
, 5
(3
), pp. 183
–190
.10.3171/spi.2006.5.3.183Copyright © 2014 by ASME
You do not currently have access to this content.