MEMS Design and Fabrication of an Implantable Sensor for Measuring Bony Fusion
Based on US 8,066,650 Strain Monitoring System and Apparatus series of patents, we are developing a sensor implanted in the lumbar spine to measure spinal fusion. Microelectromechanical Systems (MEMS) fabrication techniques were used to develop an implanted, interdigitated capacitive strain sensor that can be wirelessly interrogated with a handheld reader.
Biomechanical Testing of Sheep Spines to Characterize Bony Fusion
Sheep spines were surgically prepared as single-level lumbar spinal fusions and then mounted in a custom test fixture for measurement of spinal stiffness under simulated fusion. A characteristic curve of spinal stiffness as a function of incremental simulated fusion was developed to better understand what fusion “looks like” when measured with a strain sensor.
Clinical Evaluation Report for CE Mark of a Total Hip System
Reviewed clinical literature, FDA MAUDE databases, and National Joint Registries to determine whether or not the total hip arthroplasty (THA) system was safe, effective, and substantially equivalent to other well-performing, clinically similar THA systems available. Prepared a full report for submission to the client’s Notified Body.
Patentability Investigation for a Hip Lag Screw
Reviewed patents, company websites, and clinical literature to determine which features of the client’s hip lag screw were potentially patentable. Recommended changes to the language and scope of the patent application to provide the broadest patent coverage possible.
Meta-Analysis of Intra-Aortic Balloon Pump (IABP) Catheters
Systematically reviewed all clinical literature on IABP catheters and collected all the data on its indications for use. The data was compiled into a single, massive statistical meta-analysis and analyzed to determine the safety and efficacy of IABP catheters for a large number of indications, including refractory unstable angina, acute myocardial infarction, and cardiogenic shock.
Clinical Literature Review for Atrial Fibrillation Ablation Catheters
Evaluated the safety and efficacy of atrial fibrillation (AF) ablation catheters for CE Marking. AF ablation is an invasive technique that inserts a catheter with an ablation tip into the atria of the heart to score the atrial walls and eliminate electrical misfirings that cause AF.
Research Study on Spinal Flexibility After Lumbar Spinal Fusion
Conducting a longitudinal spinal flexibility study in collaboration with Oregon Health Sciences University (OHSU) Department of Orthopaedics on ten control subjects with no history of back surgery or serious injury, ten spinal surgery patients, and ten lumbar spinal fusion patients. The goal is to determine the degree of loss of range of motion after spinal fusion surgery and whether or not there is a difference between patients who perceive a loss of flexibility for activities of daily living (ADL) and those who do not.