Project description:The inhibition of the corrosion of metal implants is still a challenge. This study aimed to increase the corrosion resistance of Ti6Al7Nb alloy implants through surface modification, including grinding, sandblasting, and anodic oxidation followed by the deposition of a polymer coating. The aim of the work was to determine the influence of biodegradable polymer coatings on the physico-chemical properties of a Ti6Al7Nb alloy used for short-term implants. Biodegradable coatings prepared from poly(glycolide-caprolactone) (P(GCap)), poly(glycolide ?-caprolactone-lactide) (P(GCapL)), and poly(lactide-glycolide) (PLGA) were applied in the studies. The dip-coating method with three cycles of dipping was applied. Corrosion resistance was assessed on the basis of potentiodynamic studies. The studies were carried out on samples after 30, 60, and 90 days of exposure to Ringer's solution. Surface topography, wettability, and cytotoxicity studies were also carried out. The degradation process of the base material was evaluated on the basis of the mass density of the metal ions released to the solution. The results indicated the influence of the coating type on corrosion resistance. In addition, a beneficial effect of the polymer coating on the reduction of the density of the released metal ions was found, as compared to the samples without polymer coatings. The obtained results provide basic knowledge for the development of polymer coatings enriched with an active substance. The presence of ciprofloxacin in the coating did not reduce the corrosion resistance of the metal substrate. Moreover, the cytotoxicity test using the extract dilution method demonstrated that the implants' coatings are promising for further in vitro and in vivo studies.
Project description:OBJECTIVE:Closed-loop implantable neural stimulators are an exciting treatment option for patients with medically refractory epilepsy, with a number of new devices in or nearing clinical trials. These devices must accurately detect a variety of seizure types in order to reliably deliver therapeutic stimulation. While effective, broadly-applicable seizure detection algorithms have recently been published, these methods are too computationally intensive to be directly deployed in an implantable device. We demonstrate a strategy that couples devices to cloud computing resources in order to implement complex seizure detection methods on an implantable device platform. APPROACH:We use a sensitive gating algorithm capable of running on-board a device to identify potential seizure epochs and transmit these epochs to a cloud-based analysis platform. A precise seizure detection algorithm is then applied to the candidate epochs, leveraging cloud computing resources for accurate seizure event detection. This seizure detection strategy was developed and tested on eleven human implanted device recordings generated using the NeuroVista Seizure Advisory System. MAIN RESULTS:The gating algorithm achieved high-sensitivity detection using a small feature set as input to a linear classifier, compatible with the computational capability of next-generation implantable devices. The cloud-based precision algorithm successfully identified all seizures transmitted by the gating algorithm while significantly reducing the false positive rate. Across all subjects, this joint approach detected 99% of seizures with a false positive rate of 0.03?h-1. SIGNIFICANCE:We present a novel framework for implementing computationally intensive algorithms on human data recorded from an implanted device. By using telemetry to intelligently access cloud-based computational resources, the next generation of neuro-implantable devices will leverage sophisticated algorithms with potential to greatly improve device performance and patient outcomes.
Project description:BACKGROUND:Physical activity is predictive of cardiovascular outcomes in patients with cardiovascular implantable electronic devices, yet it is not regularly assessed in routine care. Current-generation cardiovascular implantable electronic devices, however, continuously monitor patient activity through a built-in accelerometer, which provides new opportunities to remotely assess patient activity, detect changes in clinical status, and incorporate these data in risk stratification models. This review critically examines the literature on device-measured physical activity (D-PA), with a focus on identifying methodological issues that may affect interpretation of study results. METHODS AND RESULTS:We conducted a systematic review of D-PA studies published from January 1 1995 to December 30 2017, identifying 29 studies meeting inclusion criteria, 5 of which were validation reports. Few technical details about D-PA sensors are reported, and procedures for analyzing and interpreting D-PA data are heterogeneous. Trends in D-PA over time and associations with clinical outcomes were reported by 22 studies, and in 7 studies, D-PA was combined with other device parameters in risk stratification models, demonstrating modest-to-good sensitivity in predicting acute heart failure decompensation, hospitalization, and mortality. CONCLUSIONS:Current evidence suggests that D-PA may be useful for assessing physical activity and predicting clinical outcomes in patients with cardiovascular implantable electronic devices when combined with other device parameters. Future work must address challenges related to D-PA data measurement, interpretation, and generalizability to support expanded clinical applications of this technology.
Project description:We describe the first implanted glucose biofuel cell (GBFC) that is capable of generating sufficient power from a mammal's body fluids to act as the sole power source for electronic devices. This GBFC is based on carbon nanotube/enzyme electrodes, which utilize glucose oxidase for glucose oxidation and laccase for dioxygen reduction. The GBFC, implanted in the abdominal cavity of a rat, produces an average open-circuit voltage of 0.57 V. This implanted GBFC delivered a power output of 38.7??W, which corresponded to a power density of 193.5??W?cm(-2) and a volumetric power of 161??W?mL(-1). We demonstrate that one single implanted enzymatic GBFC can power a light-emitting diode (LED), or a digital thermometer. In addition, no signs of rejection or inflammation were observed after 110?days implantation in the rat.
Project description:To determine whether daily physical activity (PA), as measured by implanted devices (through accelerometer sensor), was related to the risk of developing atrial arrhythmias during long-term follow-up in a population of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD). The study population was divided into 2 equally sized groups (PA cutoff point: 3.5 h/d) according to their mean daily PA recorded by the device during the 30- to 60-day period post-ICD implantation. Propensity score matching was used to compare 2 equally sized cohorts with similar characteristics between lower and higher activity patients. The primary end point was time free from the first atrial high-rate episode (AHRE) of duration ≥6 minutes. Secondary end points were: first AHRE ≥6 hours, first AHRE ≥48 hours, and a combined end point of death or HF hospitalization. Data from 770 patients (65±15 years; 66% men; left ventricular ejection fraction 35±12%) remotely monitored for a median of 25 months were analyzed. A PA ≥3.5 h/d was associated with a 38% relative reduction in the risk of AHRE ≥6 minutes (72-month cumulative survival: 75.0% versus 68.1%; log rank P=0.025), and with a reduction in the risk of AHRE ≥6 hours, AHRE ≥48 hours, and the combined end point of death or HF hospitalization (all P<0.05). In HF patients with ICD, a low level of daily PA was associated with a higher risk of atrial arrhythmias, regardless of the patients' baseline characteristics. In addition, a lower daily PA predicted death or HF hospitalization.
Project description:Under intrauterine growth restriction (IUGR), abnormal attainment of the nutrients and oxygen by the fetus restricts the normal evolution of the prenatal causing in many cases high morbidity being one of the top-ten causes of neonatal death. The current gold standards in hospitals to detect this relevant problem is the clinical observation by echography, cardiotocography and Doppler. These qualitative techniques are not conclusive and requires risky invasive fetal scalp blood testing and/or amniocentesis. We developed micro-implantable multiparametric electrochemical sensors for measuring ischemia in real time in fetal tissue and vascular. This implantable technology is designed to continuous monitoring for an early detection of ischemia to avoid potential fetal injury. Two miniaturized electrochemical sensors were developed based on oxygen and pH detection. The sensors were optimized in vitro under controlled concentration, to assess the selectivity and sensitivity required. The sensors were then validated in vivo in the ewe fetus model, by means of their insertion in the muscle leg and inside the iliac artery of the fetus. Ischemia was achieved by gradually obstructing the umbilical cord to regulate the amount of blood reaching the fetus. An important challenge in fetal monitoring is the detection of low levels of oxygen and pH changes under ischemic conditions, requiring high sensitivity sensors. Significant differences were observed in both; pH and pO2 sensors under changes from normoxia to hypoxia states in the fetus tissue and vascular with both sensors. Herein, we demonstrate the feasibility of the developed sensors for future fetal monitoring in medical applications.
Project description:Transparent epidural devices that facilitate the concurrent use of electrophysiology and neuroimaging are arising tools for neuroscience. Testing the biocompatibility and evoked immune response of novel implantable devices is essential to lay down the fundamentals of their extensive application. Here we present an immunohistochemical evaluation of a Parylene HT/indium-tin oxide (ITO) based electrocorticography (ECoG) device, and provide long-term biocompatibility data at three chronic implantation lengths. We implanted Parylene HT/ITO ECoG devices epidurally in 5 mice and evaluated the evoked astroglial response, neuronal density and cortical thickness. We found increased astroglial response in the superficial cortical layers of all mice compared to contralateral unimplanted controls. This difference was largest at the first time point and decreased over time. Neuronal density was lower on the implanted side only at the last time point, while cortical thickness was smaller in the first and second time points, but not at the last. In this study, we present data that confirms the feasibility and chronic use of Parylene HT/ITO ECoG devices.
Project description:This paper describes the fabrication and the performance of microfluidic paper-based electrochemical sensing devices (we call the microfluidic paper-based electrochemical devices, microPEDs). The microPEDs comprise paper-based microfluidic channels patterned by photolithography or wax printing, and electrodes screen-printed from conducting inks (e.g., carbon or Ag/AgCl). We demonstrated that the microPEDs are capable of quantifying the concentrations of various analytes (e.g., heavy-metal ions and glucose) in aqueous solutions. This low-cost analytical device should be useful for applications in public health, environmental monitoring, and the developing world.
Project description:The present work demonstrates the synthesis and application of permanent magnetic Nd2Fe14B microparticle (NMP)-loaded graphitic inks for realizing rapidly self-healing inexpensive printed electrochemical devices. The incorporation of NMPs into the printable ink imparts impressive self-healing ability to the printed conducting trace, with rapid (~50 ms) recovery of repeated large (3 mm) damages at the same or different locations without any user intervention or external trigger. The permanent and surrounding-insensitive magnetic properties of the NMPs thus result in long-lasting ability to repair extreme levels of damage, independent of ambient conditions. This remarkable self-healing capability has not been reported for existing man-made self-healing systems and offers distinct advantages over common capsule and intrinsically self-healing systems. The printed system has been characterized by leveraging crystallographic, magnetic hysteresis, microscopic imaging, electrical conductivity, and electrochemical techniques. The real-life applicability of the new self-healing concept is demonstrated for the autonomous repair of all-printed batteries, electrochemical sensors, and wearable textile-based electrical circuits, indicating considerable promise for widespread practical applications and long-lasting printed electronic devices.
Project description:PurposeTo propose and test a modified wideband late gadolinium enhancement (LGE) magnetic resonance (MR) imaging technique to overcome hyperintensity image artifacts caused by implanted cardiac devices.Materials and methodsWritten informed consent was obtained from all participants, and the HIPAA-compliant study protocol was approved by the institutional review board. Studies in phantoms and in a healthy volunteer were performed to test the hypothesis that the hyperintensity artifacts that are typically observed on LGE images in patients with implanted cardiac devices are caused by insufficient inversion of the affected myocardial signal. The conventional LGE MR imaging pulse sequence was modified by replacing the nonselective inversion pulse with a wideband inversion pulse. The modified LGE sequence, along with the conventional LGE sequence, was evaluated in 12 patients with implantable cardioverter defibrillators (ICDs) who were referred for cardiac MR imaging.ResultsThe ICD causes 2-6 kHz in frequency shift at locations 5-10 cm away from the device. This off-resonance falls outside the typical spectral bandwidth of the nonselective inversion pulse used in conventional LGE, which results in the hyperintensity artifact. In 10 of the 12 patients, the conventional LGE technique produced severe, uninterpretable hyperintensity artifacts in the anterior and lateral portions of the left ventricular wall. These artifacts were eliminated with use of the wideband LGE sequence, thereby enabling confident evaluation of myocardial viability.ConclusionThe modified wideband LGE MR imaging technique eliminates the hyperintensity artifacts seen in patients with cardiac devices. The technique may enable LGE MR imaging in patients with cardiac devices, in whom LGE MR imaging otherwise could not be used for diagnosis.