Design considerations for piezoelectrically powered electrical stimulation: The balance between power generation and fatigue resistance.

Quality and timing of bone healing from orthopedic surgeries, especially lumbar spinal fusion procedures, is problematic for many patients. To address this issue, clinicians often use electrical stimulation to improve surgery success rates and decrease healing time in patients with increased risk of pseudarthrosis, including smokers and diabetics. Current invasive electrical stimulation devices require an implantable battery and a second surgery for removal. Piezoelectric composites within an interbody implant generate sufficient power under physiologic loads to deliver pulsed electrical stimulation without a battery and have demonstrated promising preclinical bone growth and fusion success. The objective of the current study was to assess the power generation and fatigue resistance of three commercially manufactured piezocomposite configurations in a modified implant design to demonstrate efficacy as a robust biomaterial within osteogenic implants. The three configurations were electromechanically assessed under physiological lumbar loading conditions, and all configurations produced sufficient power to promote bone healing. Additionally, electrical and mechanical fatigue performance was assessed under high load, low cycle conditions. All configurations demonstrated runout with no gross mechanical failure and two configurations demonstrated electrical fatigue resistance. Future piezoelectric implant design decisions should be based on power generation needs to stimulate bone growth, as mechanical fatigue efficacy was proven for all piezocomposite configurations tested.