Leading the Charge in Bone Healing: Design of Compliant Layer Adaptive Composite Stacks for Electrical Stimulation in Orthopedic Implants

The overall aim of this research is to develop a robust, adaptable piezoelectric composite load-bearing biomaterial that when integrated with current implants, can harvest human motion and subsequently deliver electrical stimulation to trigger the natural bone healing and remodeling process. Building on the preclinical success of a stacked piezocomposite spinal fusion implant, compliant layer adaptive composite stacks (CLACS) were designed as a scalable biomaterial to increase efficiency of power generation while maintaining mechanical integrity under fatigue loading seen in orthopedic implants. Energy harvesting with piezoelectric material is challenging at low frequencies due to material properties that limit total power generation at these frequencies and brittle mechanical properties. Stacked generators increase power generation at lower voltage levels and resistances, but are not efficient at low frequencies seen in human motion. CLACS integrates compliant layers between the stiff piezoelectric elements within a stack, capitalizing on the benefits of stacked piezoelectric generators, while decreasing stiffness and increasing strain to amplify power generation. The first study evaluated CLACS under compressive loads, demonstrating the power amplification effect as the thickness of the compliant layer increases. The second study characterized the effect of poling direction of piezoelectric discs within a CLACS structure under multiaxial loads, demonstrating an additional increase in power generation when mixed poling directions are used to create mixed-mode CLACS. The final study compared the fatigue performance and power generation capability of three commercially fabricated piezoelectric stack generators with and without CLACS technology in modified implant assemblies. All configurations produced sufficient power to stimulate bone growth, and maintained mechanical strength throughout a high load, low cycle fatigue analysis, thus validating feasibility for use in orthopedic implants. The presented work in this dissertation provides a robust experimental understanding of CLACS and a characterization of how piezoelectric properties and composite structures can be tailored within the CLACS structure to efficiently generate power in low frequency, low impedance applications. The main motivation of this work was to develop a thorough understanding of CLACS behavior for implementation into medical implants to deliver therapeutic electrical stimulation and accelerate rate of bone growth, helping patients completely heal faster. However, the ability to tune composite stiffness by changing compliant material properties, type of piezoelectric material and poling direction, or volume fractions could benefit the energy harvesting potential in fields ranging from civil infrastructure to wind energy, to wearables and athletic equipment

Design considerations for piezocomposite materials for electrical stimulation in medical implants

This is an Accepted Manuscript of an article published by Taylor & Francis in Journal of Medical Engineering & Technology on 08 Jun 2022, available at: https://doi.org/10.1080/03091902.2022.2080881.Incidence of non-union following long bone fracture fixation and spinal fusion procedures is increasing, and very costly for patients and the medical system. Direct current (DC) electrical stimulation has shown success as an adjunct therapy to stimulate bone healing and increase surgery success rates, though drawbacks of current devices and implantable battery packs have limited widespread use. Energy harvesting utilising piezoelectric materials has been widely studied for powering devices without a battery, and a preclinical animal study has shown efficacy of a piezocomposite spinal fusion implant resulting in faster, more robust fusion. Most piezoelectric energy harvesters operate most effectively at high frequencies, limiting power generation from loads experienced by orthopaedic implants during human motion. This work characterises the efficient power generation capability of a novel composite piezoelectric material under simulated walking loads. Building on compliant layer adaptive composite stacks (CLACS), the power generation of mixed-mode CLACS (MMCLACS) is defined. Utilising poling direction to capitalise on in-plane strain generation due to compliant layer expansion, MMCLACS significantly increased power output compared to a standard piezo stack. The combination of radial and through-thickness poled piezoelectric elements within a stack to create MMCLACS significantly increases power generation under low-frequency dynamic loads. This technology can be adapted to a variety of architectures and assembled as a load-bearing energy harvester within current implants. MMCLACS integrated with implants would provide enough power to deliver bone healing electrical stimulation directly to the fusion site, decreasing non-union rates, and also could provide quantitative assessment of healing progression through load sensing

Stacked PZT Discs Generate Necessary Power for Bone Healing through Electrical Stimulation in a Composite Spinal Fusion Implant

Electrical stimulation devices can be used as adjunct therapy to lumbar spinal fusion to promote bone healing, but their adoption has been hindered by the large battery packs necessary to provide power. Piezoelectric composite materials within a spinal interbody cage to produce power in response to physiological lumbar loads have recently been investigated. A piezoelectric macro-fiber composite spinal interbody generated sufficient power to stimulate bone growth in a pilot ovine study, despite fabrication challenges. The objective of the present study was to electromechanically evaluate three new piezoelectric disc composites, 15-disc insert, seven-disc insert, and seven-disc Compliant Layer Adaptive Composite Stack (CLACS) insert, within a spinal interbody, and validate their use for electrical stimulation and promoting bone growth. All implants were electromechanically assessed under cyclic loads of 1000 N at 2 Hz, representing physiological lumbar loading. All three configurations produced at least as much power as the piezoelectric macro-fiber composites, validating the use of piezoelectric discs for this application. Future work is needed to characterize the electromechanical performance of commercially manufactured piezoelectric stacks under physiological lumbar loads, and mechanically assess the composite implants according to FDA guidelines for lumbar interbody fusion devices