The objective of this Phase I SBIR is to develop a spinal fusion implant with embedded biomechanically powered sensor. Evoke Medical's core technology is to create human-powered implantable devices that utilize piezoelectric materials to generate load-induced power. That power can then be used for various purposes: electrical stimulation of bone growth and/or load-sensing to track fusion progression. Through our current Phase II project, a fully integrated piezoelectric transforaminal lumbar inter body fusion (TLIF) implant was developed with embedded power generator and miniaturized circuitry for signal conditioning. In this TLIF implant, lower impedance piezoelectric materials were used to generate power for mechanically synced direct current (DC) electrical stimulation delivered to an electrode on the implant surface for the purposes of enhancing bone growth. No batteries are used in any Evoke Medical implant as all energy is biomechanically induced by human motion. Our preliminary work has also shown that a piezoelectric interbody implant can act as a sensor and distinguish between different applied physiological loads that correlate to fusion progression. In other industries, piezoelectric materials are often used as load sensors. In situ, mechanical loads applied to the piezoelectric device generate proportional electrical voltages that can be translated back to quantify the applied load on the device. Evoke Medical will use this inherent ability of piezoelectric materials to characterize the change in load environment within the disc space, and subsequently provide objective data to the clinician and patient to inform post-operative outcomes and treatment decisions. In spinal fusion, the load on the implant is highest when the device is first implanted and there is no bony fusion mass around and throughout the implant. As fusion progresses, the load on the implant is reduced according to the fusion grade achieved due to the increased surface area and stiffness of the growing bone structure. In this proposal, we will prove that a custom piezogenerator embedded in a spinal fusion implant with the associated circuit hardware and data acquisition software can collect, store, and wirelessly transmit changes in load within the interbody space. These changes can then be related back to fusion progression and other post-operative outcomes. Evoke Medical has already developed cost-effective manufacturing methods and demonstration of safety and efficacy of the stimulating aspect of the piezoelectric TLIF that is moving forward in the commercialization process through a DeNovo regulatory strategy. In these verification tests, we have also proven that we can successfully harvest patient motion and convert that to usable power under physiological loading conditions. By developing the load sensing aspect of the TLIF implant now, Evoke Medical will be able to jumpstart our capabilities to provide patients with biofeedback on how their implant is helping them. It will give surgeons the ability to quantify healing progress without the multitude of expensive CT scans or potentially biased patient reported outcome measures. This will allow the physician to make informed postoperative treatment decisions that could greatly improve the chances of fusion success. Commercialization of this remote load sensing data tool for spinal fusion patient care is disruptive, will help to reduce healthcare costs, and simultaneously enhance patient care, particularly in rural or remote areas or in times of limited access to healthcare providers (e.g. duringCOVID-19).In this Phase 1 project, we will first establish that utilizing a textured piezogenerator embedded in a TLIF implant will power the necessary components in a prototype load sensing circuit. The functionality of integrating the developed sensor circuit with a data acquisition framework will be verified through a large range of applied physiologic load conditions. Proving that the Evoke piezoelectric TLIF can accurately sense and output physiologic load data, differentiating between varying loads expected in fusion progression, will de-risk the integration of sensing and bone stimulating capabilities. The results of this work will set the stage for Phase II funding to integrate and miniaturize the sensing and stimulating circuits to create an integrated, dual mode stimulating and sensing spinal fusion implant. As part of this phase II work, additional in vivo validation ovine studies will be completed to justify moving forward with commercialization. Following, additional funding will be raised to complete the necessary verification & validation testing along with early clinical trials required for expanded regulatory claims around addition of the sensing capability of the TLIF implant. The thoracolumbar spine interbody market is over $1.4B/year with a compound annual growth rate of 2.9%. The proposed device is hypothesized to increase success of healing and decrease time to heal, as well as give patients and healthcare providers quantitative outcome measures without expensive CT scans or biased patient self-reporting. This would decrease overall cost of care and human suffering, as earlier, data driven post-operative decisions could be made, preventing a failed fusion and additional revision surgeries.
Public Health Relevance Statement: Project narrative: Back pain is the second most common cause for physician visits in the USA, with 70-85% of all people experiencing severe back pain at some time. Spinal fusion surgery is often used to alleviate pain and reestablish stability for the most severe cases. Currently over 600,000 fusion surgeries are performed each year in the US and growing at a rate of over 5.4% per year. The success rate of spinal fusion ranges from approximately 50-90% with poor healing in the difficult-to-fuse patients (e.g. smokers, diabetics). The determination of a successful fusion is subjective and is qualitatively determined by multiple rounds of expensive post-operative x-ray and CT imaging along with potentially biased patient reported outcome measures. In addition, the progression of a "failed fusion" is not well understood and current postoperative monitoring methods are not granular enough to adequately treat the at-risk patient. The Evoke Medical solution will provide a non-pharmacological, cost-effective way to create spinal fusion implants that will provide bone healing electrical stimulation from a human's body motion, while also providing post-operative load sensing data to both the patient and physician through a mobile app. Utilizing human-powered technology, this implant can sense changes in load as the bone grows or doesn't grow adequately, and provide this patient-specific information to patients and physicians as healing progresses; all without a battery or external stimulator. This will allow the physician to make better informed postoperative treatment decisions that could greatly improve the chances of fusion success. Both the load sensing and stimulating aspects of the spinal fusion implant will give surgeons a way to successfully improve their patient outcomes while simultaneously reducing cost of postoperative monitoring.
Project Terms: Back, Dorsum, Back Pain, Back Ache, Backache, Biofeedback, Biomechanics, biomechanical, bone, Calibration, Electric Stimulation, Electrical Stimulation, electrostimulation, Electrodes, Environment, Future, Patient Care, Patient Care Delivery, Goals, Growth, Generalized Growth, Tissue Growth, ontogeny, Health Personnel, Health Care Providers, Healthcare Providers, Healthcare worker, health care personnel, health care worker, health provider, health workforce, healthcare personnel, medical personnel, treatment provider, Human, Modern Man, implantable device, biomedical implant, implant device, indwelling device, Industry, Linear Regressions, Methods, Miniaturization, Miniaturisations, Motion, Persons, physician office visit, Office Visits, Painful, Pain, Patient Reported Measures, Patient Reported Outcomes, Patient Outcomes Assessments, Patients, Physicians, Post-Operative, Postoperative, Postoperative Period, Publishing, Risk, Safety, Ovine, Ovis, Sheep, Cell Communication and Signaling, Cell Signaling, Intracellular Communication and Signaling, Signal Transduction Systems, Signaling, biological signal transduction, Signal Transduction, Software, Computer software, Spondylosyndeses, Spinal Fusion, Spinal Column, Spine, backbone, Vertebral column, Technology, Testing, Time, X-Ray Computed Tomography, CAT scan, CT X Ray, CT Xray, CT imaging, CT scan, Computed Tomography, Tomodensitometry, X-Ray CAT Scan, X-Ray Computerized Tomography, Xray CAT scan, Xray Computed Tomography, Xray computerized tomography, catscan, computed axial tomography, computer tomography, computerized axial tomography, computerized tomography, non-contrast CT, noncontrast CT, noncontrast computed tomography, Translating, Work, Measures, Walking, Health Care Costs, Health Costs, Healthcare Costs, Outcome Measure, Custom, electric impedance, Electrical Impedance, Impedance, base, sensor, improved, Site, Area, Surface, Clinical, Phase, Physiological, Physiologic, Medical, Ensure, Failure, Rural, diabetic, Human Figure, Human body, Funding, Smoker, mechanical, Mechanics, Pulse, Physiologic pulse, Frequencies, In Situ, Texture, Spinal, Operative Procedures, Surgical, Surgical Interventions, Surgical Procedure, surgery, Operative Surgical Procedures, Visit, Surgeon, biocompatibility, biomaterial compatibility, experience, success, voltage, simulation, Self-Report, Patient Self-Report, Devices, Reporting, Abscission, Extirpation, Removal, Surgical Removal, resection, Excision, miniaturize, Bone Growth, Risk Reduction, preventing, prevent, Data, Harvest, in vivo, Collection, Patient-Focused Outcomes, Patient outcome, Patient-Centered Outcomes, Small Business Innovation Research Grant, SBIR, Small Business Innovation Research, Validation, Monitor, Process, Development, developmental, Image, imaging, Output, cost, healing, medical implant, design, designing, conditioning, Outcome, cost effective, Population, data acquisition, Implant, bone healing, bone wound healing, osseous wound healing, prototype, commercialization, data exchange, data transfer, data transmission, verification and validation, mobile application, mobile app, mobile device application, health care availability, access to health care, access to healthcare, accessibility of health care, accessibility to health care, accessibility to healthcare, health care access, health care service access, health care service availability, healthcare access, healthcare accessibility, healthcare availability, healthcare service access, healthcare service availability, mechanical load, Bone structure, skeletal structure, care costs, COVID-19, COVID19, CV-19, CV19, corona virus disease 2019, coronavirus disease 2019, coronavirus disease-19, coronavirus infectious disease-19, data tools, early phase clinical trial, early clinical trial, wireless, X-Ray Medical Imaging, Conventional X-Ray, X-Ray Imaging, Xray imaging, Xray medical imaging, conventional Xray
