Novel Spinal Cord and Epidural Blood Flow & Oxygenation Monitoring Device
Background
Spine trauma, as a result of motor vehicle accidents, falls, violence, and sports activities, is a global problem. Rates vary from 12-60 cases/million, with annual costs in the United States approaching $10,000,000,000/yr. In addition to this, many patients, adult and pediatric, suffer neurological injury secondary to vascular procedures, resection of spinal cord tumors, and as a result of attempts at the correction of acquired spine deformities. Sixty-five percent of those who present with spinal cord injury (SCI) are potentially amenable to intervention, as only 35% of all SCIs are complete. Hypotension, hypoxia, vasospasm, inflammation, edema, and hemorrhage all propagate spinal ischemia after injury. Prevention of secondary injury from ischemia may limit the severity of subsequent disability. Preventing secondary injury to the spinal cord, as with the brain, requires continued hemodynamic support and often, early surgical intervention. Prevention of secondary spinal injury is focused, to a large degree, upon the preservation or restoration of spinal cord blood flow and oxygen delivery.
Technology
While ongoing ischemia plays a prominent role in secondary spinal cord injury, no technology is available to directly and continuous measure or monitor the impact of interventions directed at improving flow and oxygen delivery to resolve the ischemia. Current methods employed to detect spinal cord ischemia, based upon electrophysiology, are indirect, temporally insensitive, nonspecific, and cumbersome. Researchers at Stony Brook University, in collaboration with UPenn, have developed a prototypical fiber optic device based on Diffuse Correlation Spectroscopy (DCS) and Diffuse Optical Spectroscopy (DOS) principles that allows for the immediate detection of changes in spinal cord blood flow and oxygenation. A prototype has undergone limited, but highly successful testing in adult Dorsett sheep. This monitoring tool potentially represents an important step forward, offering a new level of accuracy and immediacy in detecting spinal cord ischemia intraoperatively, and in the neurocritical care setting.
Advantages
This device measures the spinal cord flow and oxygen level in real time as close to the site of potential injury as possible due to its placement next to the spinal cord. This minimizes the effect of interposing tissue, for example, as compared to skin surface probes.
Placement of probe can be performed via open and percutaneous approaches with proven safety profiles for ‘similar’ devices.
The device can interrogate flow within the entire cross-section of the spinal cord and can be engineered to monitor flow and oxygenation at multiple levels.
Application
Monitoring the onset and progress of spinal cord ischemia
Prevention of secondary ischemic spinal cord injury
Assessment of the efficacy of interventions aimed at ameliorating ischemia
Intraoperative Neuromonitoring- Orthopedic/Neurosurgical spine and spinal cord
Surgery (stabilization for trauma, acquire deformities, tumors), Vascular surgery (aortic repair)
Continuous Neurointensive Care monitoring Research-Laboratory and clinical assessment of the efficacy of novel therapeutic approaches to ameliorate ischemia.
Patent Status
US-2023-0079219-A1
Stage Of Development
Prototype developed; demonstrated in animal studies on sheep. Data indicates that the device can immediately and sensitively detect the onset of spinal cord ischemia with high reproducibility.
PCT Application PCT/US2012/069626 entitled “Fiber Optic Flow and Oxygenation Monitoring Using Diffuse Correlation and Reflectance” nationalized in US and EPO.
Licensing Potential
Licensing, Development partner
Licensing Status
- License via start-up or to established medical device company - Sponsored Research Agreement
Additional Info
Further Details
Kogler AS et al “Fiber-optic Monitoring of Spinal Cord Hemodynamics in Experimental Aortic Occlusion” Anesthesiology. 2015 Dec;123(6):1362-73
https://stonybrook.technologypublisher.com/files/sites/wl4rfrtvtq2bp3lamuw1_spinal_bruceblaus_wikimedia_ccbysa3.0.png
Please note, header image is purely illustrative. Source: BruceBlaus, Wikimedia, CC BY-SA 3.0
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