Journal article
Durotomy Surrogate and Seals for Intradural Spinal Cord Stimulators: Apparatus and Review of Clinical Methods and Materials
Neuromodulation (Malden, Mass.), Vol.22(8), pp.916-929
12/2019
DOI: 10.1111/ner.12913
PMID: 30632655
Abstract
Introduction
We are developing a novel intradural spinal cord stimulator for treatment of neuropathic pain and spasticity. A key feature is the means by which it seals the dura mater to prevent leakage of cerebrospinal fluid (CSF). We have built and employed a test rig that enables evaluation of candidate seal materials.
Methods
To guide the design of the test rig, we reviewed the literature on neurosurgical durotomies. The test rig has a mock durotomy slot with a dural substitute serving as the surrogate dura mater and water as the CSF. The primary experimental goal was to evaluate the effectiveness of candidate gasket materials as seals against CSF leakage in an implanted prototype device, at both normal and super‐physiologic pressures. A secondary goal was to measure the transmembrane flows in a representative dural substitute material, to establish its baseline aqueous transport properties.
Results
The seals prevented leakage of water at the implantation site over periods of ≈ ten days, long enough for the scar tissue to form in the clinical situation. The seals also held at water pressure transients approaching 250 mm Hg. The residual volumetric flux of water through the dura substitute membrane (Durepair®) was δVT/A ≈ 0.24 mm3/min/cm2, consistent with expectations for transport through the porous membrane prior to closure and equalization of internal/external pressures.
Conclusions
We have demonstrated the workability of obtaining robust seal against leakage at the implantation site of a novel intradural stimulator using a custom‐designed test rig. Extension of the method to in vivo testing in a large animal model will be the next step.
Details
- Title: Subtitle
- Durotomy Surrogate and Seals for Intradural Spinal Cord Stimulators: Apparatus and Review of Clinical Methods and Materials
- Creators
- Sean J Nagel - Cleveland ClinicLogan Helland - University of Iowa Hospitals and ClinicsRoyce W Woodroffe - University of Iowa Hospitals and ClinicsLeonardo A Frizon - Cleveland ClinicMarshall T Holland - University of Iowa Hospitals and ClinicsAndre G Machado - Cleveland ClinicSatoshi Yamaguchi - University of Iowa Hospitals and ClinicsGeorge T Gillies - University of VirginiaMatthew A Howard - University of Iowa Hospitals and ClinicsSaul Wilson - University of Iowa Hospitals and Clinics
- Resource Type
- Journal article
- Publication Details
- Neuromodulation (Malden, Mass.), Vol.22(8), pp.916-929
- Publisher
- John Wiley & Sons, Inc; Hoboken, USA
- DOI
- 10.1111/ner.12913
- PMID
- 30632655
- ISSN
- 1094-7159
- eISSN
- 1525-1403
- Number of pages
- 13
- Language
- English
- Date published
- 12/2019
- Academic Unit
- Neurology; Iowa Neuroscience Institute; Neurosurgery; Otolaryngology
- Record Identifier
- 9984016587802771
Metrics
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