Capacitive stimulation-sensing system for instrumented bone implants: Finite element model to predict the electric stimuli delivered to the interface.

BACKGROUND: Prevalence of orthopaedic replacements are increasing around the world. The main cause of revision remains associated to the interface loosening. In this work, a computational study using the Finite element method was developed to predict the electric field stimuli delivered to trabecular bone structures, as well as to predict the sensing ability to detect different bone-implant interface scenarios. METHODS: Three finite element models were developed: two simplified models, including a Gyroid TMP structure, and a realistic model based on microCT scan of a trabecular bone from sheep vertebra. Simulations were performed using a co-surface capacitive technology for stimulating and sensing bone-implant interfaces. Different fixation scenarios were considered, namely by establishing bone-stimulator gap sizes up to 1 mm (from fixation to massive loosening scenario). Electrodes were excited with sinusoidal and square electric signals up to 10V voltage and 64kHz frequency. RESULTS: Simplification of bone geometry resulted in significant electric stimuli differences compared to the realistic bone geometry. Realistic modelling allowed to observe that, in the fixation scenario, the electric field stimuli decreased 85% from the sensor interface to a parallel plane 2 mm apart from such interface. A significant influence of the bone-stimulator distance on the electric stimuli was found: the electric stimuli magnitudes varied in the range between 0.38 V/mm (fixation scenario) and 4.8 mV/mm (massive loosening scenario) for voltages up to 10V. Strong frequency-dependent behaviours were also observed in the electric stimuli: their magnitudes can reach 106-fold decreases when the excitation frequency is decreased from 32 kHz to 14 Hz CONCLUSION: This study points out the inability of our two simplified models to predict the electric stimulation provided to different bone-implant interface scenarios. Results highlight that co-surface stimulators can deliver osteogenic electric stimuli along trabecular bone structures, ensuring low electric power excitations. Moreover, realistic models strongly enhance the sensing predictability of the bone-implant fixation states. These new and significant evidences provide a strong support to integrate co-surface capacitive into bioelectronic implants for both therapeutic and sensing operations.

Triboelectric Generator Based on Oriented Self-Assembled Peptide Microbelts.

Along with piezoelectric nanogenerators, triboelectric nanogenerators (TENGs) collecting energy from mechanical vibrations proved to be simple, low-cost, and efficient sources of electricity for various applications. In view of possible biomedical applications, the search for TENGs made of biomolecular and biocompatible materials is demanding. Diphenylalanine (FF) microstructures are promising for these applications due to their unique characteristics and ability to form various morphologies (microribbons, spherical vesicles, fibrils, micro- and nanotubes, nanorods, etc.). In this work, we developed a contact-separate mode TENG based on arrays of oriented FF microbelts deposited by dip-coating technique and studied their performance under various temperature treatments. We show that these TENGs outperform piezoelectric nanogenerators based on FF microbelts in terms of short-circuit current (ISC), open-circuit voltage (VOC), and output power. It was found that bound water captured in FF nanochannels mainly affects VOC, whereas mobile water increases ISC. We also found that the cyclization of FF molecules increases the performance of TENG likely due to an increase in surface energy and surface flattening.

Bioelectronic multifunctional bone implants: recent trends.

The concept of Instrumented Smart Implant emerged as a leading research topic that aims to revolutionize the field of orthopaedic implantology. These implants have been designed incorporating biophysical therapeutic actuation, bone-implant interface sensing, implant-clinician communication and self-powering ability. The ultimate goal is to implement revist interface, controlled by clinicians/surgeons without troubling the quotidian activities of patients. Developing such high-performance technologies is of utmost importance, as bone replacements are among the most performed surgeries worldwide and implant failure rates can still exceed 10%. In this review paper, an overview to the major breakthroughs carried out in the scope of multifunctional smart bone implants is provided. One can conclude that many challenges must be overcome to successfully develop them as revision-free implants, but their many strengths highlight a huge potential to effectively establish a new generation of high-sophisticated biodevices.

Multifunctional Smart Bone Implants: Fiction or Future?-A New Perspective.

Implantable medical devices have been developed to provide multifunctional ability to numerous bioapplications. In the scope of orthopaedics, four methodologies were already proposed to design implant technologies: non-instrumented passive implants, non-instrumented active implants, instrumented passive implants and instrumented active implants. Even though bone replacements are among the most performed surgeries worldwide, implant failure rates can still exceed 10%. Controversial positions multiply in the scientific community about the potential of each methodology to minimize the burden related to implant failures. In this perspective paper, we argue that the next technological revolution in the field of implantable bone devices will most likely emerge with instrumented active implants as multifunctional smart devices extracorporeally controlled by clinicians/surgeons. Moreover, we provide a new perspective about implant technology: the essence of instrumented implants is to enclose a hybrid architecture in which optimal implant performances require both smart instrumentation and smart coatings, although the implant controllability must be ensured by extracorporeal systems.

Multiscale Sensing of Bone-Implant Loosening for Multifunctional Smart Bone Implants: Using Capacitive Technologies for Precision Controllability.

The world population growth and average life expectancy rise have increased the number of people suffering from non-communicable diseases, namely osteoarthritis, a disorder that causes a significant increase in the years lived with disability. Many people who suffer from osteoarthritis undergo replacement surgery. Despite the relatively high success rate, around 10% of patients require revision surgeries, mostly because existing implant technologies lack sensing devices capable of monitoring the bone-implant interface. Among the several monitoring methodologies already proposed as substitutes for traditional imaging methods, cosurface capacitive sensing systems hold the potential to monitor the bone-implant fixation states, a mandatory capability for long-term implant survival. A multifaceted study is offered here, which covers research on the following points: (1) the ability of a cosurface capacitor network to effectively monitor bone loosening in extended peri-implant regions and according to different stimulation frequencies; (2) the ability of these capacitive architectures to provide effective sensing in interfaces with hydroxyapatite-based layers; (3) the ability to control the operation of cosurface capacitive networks using extracorporeal informatic systems. In vitro tests were performed using a web-based network sensor composed of striped and interdigitated capacitive sensors. Hydroxyapatite-based layers have a minor effect on determining the fixation states; the effective operation of a sensor network-based solution communicating through a web server hosted on Raspberry Pi was shown. Previous studies highlight the inability of current bone-implant fixation monitoring methods to significantly reduce the number of revision surgeries, as well as promising results of capacitive sensing systems to monitor micro-scale and macro-scale bone-interface states. In this study, we found that extracorporeal informatic systems enable continuous patient monitoring using cosurface capacitive networks with or without hydroxyapatite-based layers. Findings presented here represent significant advancements toward the design of future multifunctional smart implants.

Capacitive interdigitated system of high osteoinductive/conductive performance for personalized acting-sensing implants.

Replacement orthopedic surgeries are among the most common surgeries worldwide, but clinically used passive implants cannot prevent failure rates and inherent revision arthroplasties. Optimized non-instrumented implants, resorting to preclinically tested bioactive coatings, improve initial osseointegration but lack long-term personalized actuation on the bone-implant interface. Novel bioelectronic devices comprising biophysical stimulators and sensing systems are thus emerging, aiming for long-term control of peri-implant bone growth through biointerface monitoring. These acting-sensing dual systems require high frequency (HF) operations able to stimulate osteoinduction/osteoconduction, including matrix maturation and mineralization. A sensing-compatible capacitive stimulator of thin interdigitated electrodes and delivering an electrical 60 kHz HF stimulation, 30 min/day, is here shown to promote osteoconduction in pre-osteoblasts and osteoinduction in human adipose-derived mesenchymal stem cells (hASCs). HF stimulation through this capacitive interdigitated system had significant effects on osteoblasts' collagen-I synthesis, matrix, and mineral deposition. A proteomic analysis of microvesicles released from electrically-stimulated osteoblasts revealed regulation of osteodifferentiation and mineralization-related proteins (e.g. Tgfb3, Ttyh3, Itih1, Aldh1a1). Proteomics data are available via ProteomeXchange with the identifier PXD028551. Further, under HF stimulation, hASCs exhibited higher osteogenic commitment and enhanced hydroxyapatite deposition. These promising osteoinductive/conductive capacitive stimulators will integrate novel bioelectronic implants able to monitor the bone-implant interface and deliver personalized stimulation to peri-implant tissues.

Towards an effective sensing technology to monitor micro-scale interface loosening of bioelectronic implants.

Instrumented implants are being developed with a radically innovative design to significantly reduce revision surgeries. Although bone replacements are among the most prevalent surgeries performed worldwide, implant failure rate usually surpasses 10%. High sophisticated multifunctional bioelectronic implants are being researched to incorporate cosurface capacitive architectures with ability to deliver personalized electric stimuli to peri-implant target tissues. However, the ability of these architectures to detect bone-implant interface states has never been explored. Moreover, although more than forty technologies were already proposed to detect implant loosening, none is able to ensure effective monitoring of the bone-implant debonding, mainly during the early stages of loosening. This work shows, for the first time, that cosurface capacitive sensors are a promising technology to provide an effective monitoring of bone-implant interfaces during the daily living of patients. Indeed, in vitro experimental tests and simulation with computational models highlight that both striped and circular capacitive architectures are able to detect micro-scale and macro-scale interface bonding, debonding or loosening, mainly when bonding is weakening or loosening is occurring. The proposed cosurface technologies hold potential to implement highly effective and personalized sensing systems such that the performance of multifunctional bioelectronic implants can be strongly improved. Findings were reported open a new research line on sensing technologies for bioelectronic implants, which may conduct to great impacts in the coming years.

Natural and Eco-Friendly Materials for Triboelectric Energy Harvesting.

Triboelectric nanogenerators (TENGs) are promising electric energy harvesting devices as they can produce renewable clean energy using mechanical excitations from the environment. Several designs of triboelectric energy harvesters relying on biocompatible and eco-friendly natural materials have been introduced in recent years. Their ability to provide customizable self-powering for a wide range of applications, including biomedical devices, pressure and chemical sensors, and battery charging appliances, has been demonstrated. This review summarizes major advances already achieved in the field of triboelectric energy harvesting using biocompatible and eco-friendly natural materials. A rigorous, comparative, and critical analysis of preparation and testing methods is also presented. Electric power up to 14 mW was already achieved for the dry leaf/polyvinylidene fluoride-based TENG devices. These findings highlight the potential of eco-friendly self-powering systems and demonstrate the unique properties of the plants to generate electric energy for multiple applications.

Altering the Course of Technologies to Monitor Loosening States of Endoprosthetic Implants.

Musculoskeletal disorders are becoming an ever-growing societal burden and, as a result, millions of bone replacements surgeries are performed per year worldwide. Despite total joint replacements being recognized among the most successful surgeries of the last century, implant failure rates exceeding 10% are still reported. These numbers highlight the necessity of technologies to provide an accurate monitoring of the bone-implant interface state. This study provides a detailed review of the most relevant methodologies and technologies already proposed to monitor the loosening states of endoprosthetic implants, as well as their performance and experimental validation. A total of forty-two papers describing both intracorporeal and extracorporeal technologies for cemented or cementless fixation were thoroughly analyzed. Thirty-eight technologies were identified, which are categorized into five methodologies: vibrometric, acoustic, bioelectric impedance, magnetic induction, and strain. Research efforts were mainly focused on vibrometric and acoustic technologies. Differently, approaches based on bioelectric impedance, magnetic induction and strain have been less explored. Although most technologies are noninvasive and are able to monitor different loosening stages of endoprosthetic implants, they are not able to provide effective monitoring during daily living of patients.

Novel magnetic stimulation methodology for low-current implantable medical devices.

Recent studies highlight the ability of inductive architectures to deliver therapeutic magnetic stimuli to target tissues and to be embedded into small-scale intracorporeal medical devices. However, to date, current micro-scale biomagnetic devices require very high electric current excitations (usually exceeding 1 A) to ensure the delivery of efficient magnetic flux densities. This is a critical problem as advanced implantable devices demand self-powering, stand-alone and long-term operation. This work provides, for the first time, a novel small-scale magnetic stimulation system that requires up to 50-fold lower electric current excitations than required by relevant biomagnetic technology recently proposed. Computational models were developed to analyse the magnetic stimuli distributions and densities delivered to cellular tissues during in vitro experiments, such that the feasibility of this novel stimulator can be firstly evaluated on cell culture tests. The results demonstrate that this new stimulative technology is able to deliver osteogenic stimuli (0.1-7 mT range) by current excitations in the 0.06-4.3 mA range. Moreover, it allows coil designs with heights lower than 1 mm without significant loss of magnetic stimuli capability. Finally, suitable core diameters and stimulator-stimulator distances allow to define heterogeneity or quasi-homogeneity stimuli distributions. These results support the design of high-sophisticated biomagnetic devices for a wide range of therapeutic applications.

Capacitive technologies for highly controlled and personalized electrical stimulation by implantable biomedical systems.

Cosurface electrode architectures are able to deliver personalized electric stimuli to target tissues. As such, this technology holds potential for a variety of innovative biomedical devices. However, to date, no detailed analyses have been conducted to evaluate the impact of stimulator architecture and geometry on stimuli features. This work characterizes, for the first time, the electric stimuli delivered to bone cellular tissues during in vitro experiments, when using three capacitive architectures: stripped, interdigitated and circular patterns. Computational models are presented that predict the influence of cell confluence, cosurface architecture, electrodes geometry, gap size between electrodes and power excitation on the stimuli delivered to cellular layers. The results demonstrate that these stimulators are able to deliver osteoconductive stimuli. Significant differences in stimuli distributions were observed for different stimulator designs and different external excitations. The thickness specification was found to be of utmost importance. In vitro experiments using an osteoblastic cell line highlight that cosurface stimulation at a low frequency can enhance osteoconductive responses, with some electrode-specific differences being found. A major feature of this type of work is that it enables future detailed analyses of stimuli distribution throughout more complex biological structures, such as tissues and organs, towards sophisticated biodevice personalization.

Predictions of Birmingham hip resurfacing implant offset - In vitro and numerical models.

The number of hip resurfacing arthroplasty procedures has declined dramatically in recent years, for reasons related to the survival rate. Some studies suggest that metal particles are the main critical problem, but do not specify the effect of femoral position on the failure rate. The present study aims to analyze whether the positioning of the resurfacing head implant is important in the distribution of bone strains and in the risk of fracture of the femur. Three in vitro experimental models received the Birmingham hip resurfacing implant to replicate the total hip joint. The resurfacing head of the implanted models was placed in three different offset positions: in a positive offset, with the same femoral head center and in a negative offset. The numerical models were validated by correlating numerical and experimental results. Comparing experimental results from the implanted and intact femurs highlights a strain increase of up to 48% in the proximal medial femur region for positive offset and up to 18% in the neutral position. A reduction of 72% for negative offset (valgus position) was also measured experimentally. A significant change in strain distributions was observed with a resurfacing hip system and increased risk of neck fracture was found using the resurfacing head in positive offset. The iliac bone presents a high decrease in strains that will induce bone loss in the long term. Among the offset positions tested, results suggest that the negative offset (valgus position) and the natural position are the best equilibrated for better long-term results.

New cosurface capacitive stimulators for the development of active osseointegrative implantable devices.

Non-drug strategies based on biophysical stimulation have been emphasized for the treatment and prevention of musculoskeletal conditions. However, to date, an effective stimulation system for intracorporeal therapies has not been proposed. This is particularly true for active intramedullary implants that aim to optimize osseointegration. The increasing demand for these implants, particularly for hip and knee replacements, has driven the design of innovative stimulation systems that are effective in bone-implant integration. In this paper, a new cosurface-based capacitive system concept is proposed for the design of implantable devices that deliver controllable and personalized electric field stimuli to target tissues. A prototype architecture of this system was constructed for in vitro tests, and its ability to deliver controllable stimuli was numerically analyzed. Successful results were obtained for osteoblastic proliferation and differentiation in the in vitro tests. This work provides, for the first time, a design of a stimulation system that can be embedded in active implantable devices for controllable bone-implant integration and regeneration. The proposed cosurface design holds potential for the implementation of novel and innovative personalized stimulatory therapies based on the delivery of electric fields to bone cells.

Magnetic levitation-based electromagnetic energy harvesting: a semi-analytical non-linear model for energy transduction.

Magnetic levitation has been used to implement low-cost and maintenance-free electromagnetic energy harvesting. The ability of levitation-based harvesting systems to operate autonomously for long periods of time makes them well-suited for self-powering a broad range of technologies. In this paper, a combined theoretical and experimental study is presented of a harvester configuration that utilizes the motion of a levitated hard-magnetic element to generate electrical power. A semi-analytical, non-linear model is introduced that enables accurate and efficient analysis of energy transduction. The model predicts the transient and steady-state response of the harvester a function of its motion (amplitude and frequency) and load impedance. Very good agreement is obtained between simulation and experiment with energy errors lower than 14.15% (mean absolute percentage error of 6.02%) and cross-correlations higher than 86%. The model provides unique insight into fundamental mechanisms of energy transduction and enables the geometric optimization of harvesters prior to fabrication and the rational design of intelligent energy harvesters.

Instrumented hip joint replacements, femoral replacements and femoral fracture stabilizers.

This paper reviews instrumented hip joint replacements, instrumented femoral replacements and instrumented femoral fracture stabilizers. Examination of the evolution of such implants was carried out, including the detailed analysis of 16 architectures, designed by 8 research teams and implanted in 32 patients. Their power supply, measurement, communication, processing and actuation systems were reviewed, as were the tests carried out to evaluate their performance and safety. These instrumented implants were only designed to measure biomechanical and thermodynamic quantities in vivo, in order to use such data to conduct research projects and optimize rehabilitation processes. The most promising trend is to minimize aseptic loosening and/or infection following hip or femoral replacements or femoral stabilization procedures by using therapeutic actuators inside instrumented implants to apply controlled stimuli in the bone-implant interface.

Novel intelligent real-time position tracking system using FPGA and fuzzy logic.

The main aim of this paper is to test if FPGAs are able to achieve better position tracking performance than software-based soft real-time platforms. For comparison purposes, the same controller design was implemented in these architectures. A Multi-state Fuzzy Logic controller (FLC) was implemented both in a Xilinx(®) Virtex-II FPGA (XC2v1000) and in a soft real-time platform NI CompactRIO(®)-9002. The same sampling time was used. The comparative tests were conducted using a servo-pneumatic actuation system. Steady-state errors lower than 4 µm were reached for an arbitrary vertical positioning of a 6.2 kg mass when the controller was embedded into the FPGA platform. Performance gains up to 16 times in the steady-state error, up to 27 times in the overshoot and up to 19.5 times in the settling time were achieved by using the FPGA-based controller over the software-based FLC controller.

Instrumented hip implants: electric supply systems.

Instrumented hip implants were proposed as a method to monitor and predict the biomechanical and thermal environment surrounding such implants. Nowadays, they are being developed as active implants with the ability to prevent failures by loosening. The generation of electric energy to power active mechanisms of instrumented hip implants remains a question. Instrumented implants cannot be implemented without effective electric power systems. This paper surveys the power supply systems of seventeen implant architectures already implanted in-vivo, namely from instrumented hip joint replacements and instrumented fracture stabilizers. Only inductive power links and batteries were used in-vivo to power the implants. The energy harvesting systems, which were already designed to power instrumented hip implants, were also analyzed focusing their potential to overcome the disadvantages of both inductive-based and battery-based power supply systems. From comparative and critical analyses of the methods to power instrumented implants, one can conclude that: inductive powering and batteries constrain the full operation of instrumented implants; motion-driven electromagnetic energy harvesting is a promising method to power instrumented passive and active hip implants.