Development of an Osteoinductive Spinal Fusion Implant for Enhanced Fusion Rates

Evoke Medical, Llc, Lawrence KS

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): The objective of this Phase I STTR research is to develop and test osteoinductive lumbar spinal fusion implant prototypes made using materials technology developments discovered by the PI at the University of Kansas. In preliminary work, lower impedance piezoelectric composite materials that generate power for direct current (DC) electrical stimulation applications were manufactured and electromechanically characterized. In an osteoinductive spinal fusion implant design, an insulated piezoelectric composite acts as a power generator to supply negative DC electrical stimulation to a Titanium electrode that is mounted on the surface of the implant. Evoke Medical will build on this work and implant design concept to develop and commercialize osteoinductive piezoelectric spinal fusion implants. In lumbar spine fusion, the success rate reported in published studies ranges from approximately 50-90%. This disparity is primarily due to the high number of difficult-to-fuse patients (e.g., smokers, diabetics). DC electrical stimulation has been shown to help increase success rates in the difficult-to-fuse population and accelerate the rate of bone healing in all patients. Preliminay experimental materials research results and pilot large animal studies using a piezoelectric composite spinal fusion implant showed that it could generate faster and better healing in spine fusion. While preliminary studies show great promise, the current methods of manufacturing this implant are not cost-effective; it is imperative that Evoke Medical move forward with R&D focused on improving the reliability and quality of the manufacturing methods and proving that an actual implant design can withstand mechanical loading. Without improved manufacturing methods, this potentially disruptive technology has little hope for commercial success. In this Phase I STTR, we will perform research to develop new methods of making piezoelectric composites that have sufficient mechanical and electromechanical properties and are cost-effective to manufacture. In Specific Aim 1, we will establish reliable and cost-effective methods of manufacturing stacked layered piezoelectric composite inserts. In Specific Aim 2, we will prove that piezoelectric composite inserts can produce sufficient power at body loading conditions while maintaining satisfactory mechanical strength. In Specific Aim 3, we will prove that the piezoelectric spinal interbody implant has satisfactory electromechanical and mechanical properties for use as DC current generating spinal fusion implants. The results of this work will yield knowledge about manufacturing of stacked layer structured composites, mechanical properties of those composites, and the suitability of the materials for use in implants and will set the stage for Phase II work in further translation of the implant design concept.