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Shape Memory Nitinol Based Minimally Invasive Spinal Cord Stimulation Device Concept for Improved Pain Management
Shailen G Sampath1, Albert E Telfeian2, Ruth Sullivan1
1Center for Biomedical Engineering, Brown University, Providence, RI; School of Engineering, Brown University, Providence, RI.
Pain Physician
|March 24, 2022
Summary
A novel nitinol-based cylindrical spinal cord stimulation lead transforms to an optimal shape after minimally invasive insertion. This design aims to reduce complications and improve pain relief by enhancing coverage and minimizing migration.
Area of Science:
- Biomedical Engineering
- Neurosurgery
- Materials Science
Background:
- Spinal cord stimulation (SCS) is a common neuropathic pain treatment using paddle or cylindrical leads.
- Paddle leads offer better coverage but require invasive surgery, while cylindrical leads are minimally invasive but have migration and coverage issues.
Purpose of the Study:
- To develop an improved cylindrical SCS device with a shape-changing capability for better therapeutic outcomes.
- The goal is to reduce long-term complications, lead migration, and enhance dermatome coverage.
Main Methods:
- Designed a nitinol-based cylindrical lead utilizing its shape memory alloy properties.
- Programmed the nitinol core for percutaneous insertion and in-body shape transformation.
- Tested lead deployment in lab models and human cadavers.
Main Results:
- Successfully demonstrated the deployment of the nitinol component in both lab and cadaveric epidural spaces.
- The minimally invasive insertion and deployment indicate clinical potential for a custom-shaped SCS electrode.
Conclusions:
- Nitinol's shape memory properties offer a promising solution for cylindrical SCS leads.
- Body temperature-induced geometry changes could reduce migration, increase coverage, and enhance electrode density while retaining minimally invasive benefits.
