Katherine Gibson-Corley DVM, PhD, DACVP. Pathology Grand Rounds March 27, 2014
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1 Katherine Gibson-Corley DVM, PhD, DACVP Pathology Grand Rounds March 27, 2014
2 Outline Introduction to spinal cord stimulation (SCS) Current SCS devices The Iowa-Patch TM (I-Patch) Post-surgical pathologies associated with SCS In-vivo ovine preclinical testing Acute studies Chronic (1 year) studies Conclusions and future directions
3 Spinal cord stimulation (SCS) First used clinically in 1967 For intractable pain in cancer patients Presently 35,000 SCS devices are implanted each year in North America Currently employed primarily for Failed back surgery syndrome Complex regional pain syndrome Refractory pain due to ischemia poweroveryourpain.com
4 Spinal cord stimulators Consists of Stimulating electrodes implanted on/near spinal cord Conducting wires connecting electrodes to generator An electrical pulse generator implanted in the abdominal/gluteal region Generator remote control restoreyourfunction.com
5 Spinal cord stimulators Forms an electrical circuit: Pulse generator provides a voltage Voltage sent to the electrodes Voltage sent to the tissues under the electrodes creating an electrical field
6 Spinal cord stimulation (SCS) Mechanism of action poorly understood Activation of large diameter afferent fibers in the dorsal columns and/or rootlets (inhibitory) Inhibition of nociceptive small diameter fibers Cerebral activity may also be altered studyblue.com
7 Historically the first SCS devices were intradural Risks: Invasive surgery CSF leaks CSF fistula formation Spinal cord compression Infections Intradural SCS
8 Epidural SCS Currently the method utilized clinically 1-2 years of relief in 25-50% of implanted patients nibib.nih.gov
9 Epidural SCS Marked variability in clinical outcomes Electrical shunting effects of the cerebrospinal fluid (CSF) Estimated >90% of current is shunted from target tissue Remaining 10% reaches only the superficial ( µm) layer of the dorsal columns dfwspineinfo.com
10 Iowa-Patch TM Intradural SCS device implanted directly on the pial surface of the cord Oya Strap Gibson-Corley, 2012
11 Dentate ligaments Human cadaver Gibson-Corley, 2012 Gibson-Corley, 2012
12 Dentate Ligaments Sheep Gibson-Corley, 2012
13 Iowa-Patch TM Wired device (eventual goal to be wireless) 0.13mm thick transparent silicone Attachment arms to secure to dentate ligaments 6-9 platinum-iridium electrodes 0.5mm diameter Leads connected to a stimulator
14 Advantages: Iowa-Patch TM Selectively activate targeted axons within the cord Minimizing leakage currents to neighboring neural structures
15 Post-surgical pathologies with intradural SCS Gibson-Corley, In Press
16 Cerebrospinal fluid leakage Due to incomplete healing of the durotomy Subcutaneous swelling around the electrode cable at the traversal point through the dura Easily and effectively managed Follow-up surgical re-approximation of the dura Temporary lumbar drain of CSF Minimized by the use of a dural cuff Gibson-Corley, In Press
17 Spinal cord compression/trauma I-patch sits directly upon the spinal cord pial surface Concern is compression of the cord and/or blood vessels on the dorsal surface Minimized by the use of circular lead wires which are malleable and securing the device to the dentate ligaments Gibson-Corley, In Press
18 Infection Include: Localized infection, sepsis, meningitis and/or arachnoiditis at the site of the electrode Rare Treatable, although can include the requirement for more surgery Gibson-Corley, In Press
19 Hematoma formation A single report of hematoma formation under SCS electrodes 18 months after placement Gibson-Corley, In Press Grillo, 1974
20 Chronic fibrosis A very common finding in long term animal studies Extradural and intradural Secondary to both the implant itself and electrical stimulation Can result in poor transmission of current and deterioration in efficacy Gibson-Corley, In Press
21 In vivo ovine model Adult Suffolk sheep Multi-level laminectomy and durotomy to expose dorsal spinal cord for implantation Animals were implanted +/- electrically stimulated Surgeries ranged hours
22 Key findings Acute ovine experiments I-patch can be secured to spinal cord surface using the dentate ligaments No significant spinal cord pathology Effectively activate somatosensory pathways
23 Acute ovine experiments Flouty, 2012
24 Somatosensory pathway activation Tibial nerve stimulation (a painful stimulus) High frequency spinal cord stimulation (SCS) via the I-Patch (to provide pain relief) Measured somatosensory evoked potentials via cortical grid to see if there is attenuation of the SSEP spike with SCS Flouty, 2013
25 Flouty, Occurred at signal strengths routinely used by devices in standard clinical use
26 Chronic ovine experiments Chronic implantation (12 month period) Clinically sheep are normal Variable impedances Lead/circuit breaks? Fibrosis? Variable proliferation of fibrous connective tissue at laminectomy site Variable new bone formation at laminectomy site Complete necropsy with histopathology of key organ systems
27 Chronic studies: gross findings
28 Chronic studies: imaging Oya strap Screws to anchor strap Laminectomy I-patch electrode Leads Laminectomy
29 Chronic studies: imaging Oya strap I-Patch Electrode Bone proliferation Cord I-Patch Leads Electrode I-Patch Cord
30
31
32 Chronic studies: thick sections Electrode Proliferative fibrous connective tissue around I- patch Spinal cord
33 Chronic studies: histopathology A B C C B D
34 Immunohistochemistry Chronic I-Patch Control Cord segment far away from I-patch GFAP Iba-1
35 Conclusions The I-patch can be secured to spinal cord surface Long term implantation of the I-patch itself is not harmful After long term implantation SCS is still effective in some animals Some had very high impedances After implantation we can effectively activate somatosensory pathways Chronic fibrosis around the I-patch and pial proliferation does occur
36 Current Studies Thick sections of the remaining tissues Intravascular perfusion of sheep for appropriate fixation and to minimize handling artifacts Continue long term implant studies for safety and efficacy
37 Future Directions GLP studies and FDA approval for eventual use in humans Creating and characterizing new ovine models to directly test I-Patch SCS Chronic pain model via partial nerve ligation Spasticity model using a drop tower injury model
38 Acknowledgments Matt Howard George Gillies (UVA) Doug Fredericks U of Iowa Neurosurgery Hiroyuki Oya Oliver Flouty Saul Wilson Chandan Reddy Steve Viljoen Brian Wilson U of Iowa Engineering Nicole Grosland Kirsten Stoner Iowa State University Nick Jeffery Sina Safayi U of Iowa Pathology Comparative Pathology Lab Histology Research Lab Evergreen Medical
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