NIDA Boosts Research and Development of Medical Devices for Substance use Disorder via the NIH Blueprint MedTech Initiative.

: Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. : National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD.

Reducing RF-induced Heating near Implanted Leads through High-Dielectric Capacitive Bleeding of Current (CBLOC).

Patients with implanted medical devices such as deep brain stimulation or spinal cord stimulation are often unable to receive magnetic resonance imaging (MRI). This is because once the device is within the radiofrequency (RF) field of the MRI scanner, electrically conductive leads act as antenna, amplifying the RF energy deposition in the tissue and causing possible excessive tissue heating. Here we propose a novel concept in lead design in which 40cm lead wires are coated with a ~1.

Parallel transmission to reduce absorbed power around deep brain stimulation devices in MRI: Impact of number and arrangement of transmit channels.

Purpose: To assess the mean and variance performance of parallel transmission (pTx) coils for reduction of the absorbed power around electrodes (APAE) in patients implanted with deep brain stimulation (DBS) devices.

Methods: We simulated 4 pTx coils (8 and 16 channels, head and body coils) and a birdcage body coil. We characterized the RF safety risk using the APAE, which is the integral of the deposited power (in Watts) in a small cylindrical volume of brain tissue surrounding the electrode tips.

Numerical and Experimental Analysis of Radiofrequency-Induced Heating Versus Lead Conductivity During EEG-MRI at 3 T.

This study investigates radiofrequency (RF)-induced heating in a head model with a 256-channel electroencephalogram (EEG) cap during magnetic resonance imaging (MRI). Nine computational models were implemented each with different EEG lead electrical conductivity, ranging from 1 to 5.8 × 10 S/m.

A Study on the Feasibility of the Deep Brain Stimulation (DBS) Electrode Localization Based on Scalp Electric Potential Recordings.

Deep Brain Stimulation (DBS) is an effective therapy for patients disabling motor symptoms from Parkinson's disease, essential tremor, and other motor disorders. Precise, individualized placement of DBS electrodes is a key contributor to clinical outcomes following surgery. Electroencephalography (EEG) is widely used to identify the sources of intracerebral signals from the potential on the scalp.

The 'virtual DBS population': five realistic computational models of deep brain stimulation patients for electromagnetic MR safety studies.

We design, develop, and disseminate a 'virtual population' of five realistic computational models of deep brain stimulation (DBS) patients for electromagnetic (EM) analysis. We found five DBS patients in our institution' research patient database who received high quality post-DBS surgery computer tomography (CT) examinations of the head and neck. Three patients have a single implanted pulse generator (IPG) and the two others have two IPGs (one for each lead).

Radio-Frequency Safety Assessment of Stents in Blood Vessels During Magnetic Resonance Imaging.

The purpose of this study was to investigate the need for high-resolution detailed anatomical modeling to correctly estimate radio-frequency (RF) safety during magnetic resonance imaging (MRI). RF-induced heating near metallic implanted devices depends on the electric field tangential to the device ( ). and specific absorption rate (SAR) were analyzed in blood vessels of an anatomical model to understand if a standard gel phantom accurately represents the potential heating in tissues due to passive vascular implants such as stents.

Effect Of Incident Field Magnitude And Phase Distribution On Rfinduced Heating Due To Hip Implants.

We investigated how the distribution of magnitude and phase of incident electric field affects RFinduced heating near a hip implant. The results showed that varying the incident electric field, for example due to different phantom shape or different landmark position, for two-or three-dimensional implants can result in up to 50% variation of estimated RF-induced temperature rise. To avoid systematic errors in predicting the RF-induced heating, varied distributions of the incident electric field should be applied.

RF-induced heating in tissue near bilateral DBS implants during MRI at 1.5 T and 3T: The role of surgical lead management.

Access to MRI is limited for patients with deep brain stimulation (DBS) implants due to safety hazards, including radiofrequency (RF) heating of tissue surrounding the leads. Computational models provide an exquisite tool to explore the multi-variate problem of RF heating and help better understand the interaction of electromagnetic fields and biological tissues. This paper presents a computational approach to assess RF-induced heating, in terms of specific absorption rate (SAR) in the tissue, around the tip of bilateral DBS leads during MRI at 64MHz/1.

Changes in the specific absorption rate (SAR) of radiofrequency energy in patients with retained cardiac leads during MRI at 1.5T and 3T.

Purpose: To evaluate the local specific absorption rate (SAR) and heating around retained cardiac leads during MRI at 64 MHz (1.5T) and 127 MHz (3T) as a function of RF coil type and imaging landmark.

Methods: Numerical models of retained cardiac leads were built from CT and X-ray images of 6 patients with retained cardiac leads.

Retrospective analysis of RF heating measurements of passive medical implants.

Purpose: The test reports for the RF-induced heating of metallic devices of hundreds of medical implants have been provided to the U.S. Food and Drug Administration as a part of premarket submissions.

Realistic modeling of deep brain stimulation implants for electromagnetic MRI safety studies.

We propose a framework for electromagnetic (EM) simulation of deep brain stimulation (DBS) patients in radiofrequency (RF) coils. We generated a model of a DBS patient using post-operative head and neck computed tomography (CT) images stitched together into a 'virtual CT' image covering the entire length of the implant. The body was modeled as homogeneous.

The Role of Computational Modeling and Simulation in the Total Product Life Cycle of Peripheral Vascular Devices.

The total product life cycle (TPLC) of medical devices has been defined by four stages: discovery and ideation, regulatory decision, product launch, and postmarket monitoring. Manufacturers of medical devices intended for use in the peripheral vasculature, such as stents, inferior vena cava (IVC) filters, and stent-grafts, mainly use computational modeling and simulation (CM&S) to aid device development and design optimization, supplement bench testing for regulatory decisions, and assess postmarket changes or failures. For example, computational solid mechanics and fluid dynamics enable the investigation of design limitations in the ideation stage.

RF Safety Evaluation of a Breast Tissue Expander Device for MRI: Numerical Simulation and Experiment.

This study describes the MRI-related radio frequency (RF) safety evaluation of breast tissue expander devices to establish safety criteria. Numerical simulations and experimental measurements were performed at 64 MHz with a gel phantom containing a breast expander. Additionally, computational modeling was performed (64 and 128 MHz) with an adult female model, containing a virtually implanted breast tissue expander device for four imaging landmark positions.

Improvement of Electromagnetic Field Distributions Using High Dielectric Constant (HDC) Materials for CTL-Spine MRI: Numerical Simulations and Experiments.

This study investigates the use of pads with high dielectric constant (HDC) materials to alter electromagnetic field distributions in patients during magnetic resonance imaging (MRI). The study was performed with numerical simulations and phantom measurements. An initial proof-of-concept and validation was performed using a phantom at 64 MHz, showing increases of up to 10% in electromagnetic field when using distilled water as the high dielectric material.

Investigating the effect of coil model losses on computational electromagnetic exposure of an ASTM phantom at 64 MHz MRI.

The goal of this work is to investigate the effect of coil losses on the electromagnetic field generated in an ASTM phantom by a birdcage coil. The study was based on different numerical implementations of an RF body coil at 64 MHz, using the same 3D EM and RF circuit co-simulation procedure. The coil quality factor was evaluated with respect to losses due to power feed mismatch and to resistive losses of the coil components.

A numerical investigation on the effect of RF coil feed variability on global and local electromagnetic field exposure in human body models at 64 MHz.

Purpose: This study aims to investigate how the positions of the feeding sources of the transmit radiofrequency (RF) coil, field orientation direction with respect to the patient, and patient dimensions affect the global and local electromagnetic exposure in human body models.

Methods: Three RF coil models were implemented, namely a specific two-source (S2) feed and two multisource feed configurations: generic 32-source (G32) and hybrid 16-source (H16). Thirty-two feeding conditions were studied for the S2, whereas two were studied for the G32 and H16.

Effects of tuning conditions on near field of MRI transmit birdcage coil at 64 MHz.

This study investigates how the tuning conditions of a 64 MHz / 1.5 T radio frequency (RF) birdcage coil modeled with an RF circuit and 3D electromagnetic co-simulation affect the electric and magnetic near-field distribution. Four models were implemented with different tuning conditions and difference between numerical results and measurements was evaluated.

RF induced energy for partially implanted catheters: a computational study.

Magnetic Resonance Imaging (MRI) is a radiological imaging technique widely used in clinical practice. MRI has been proposed to guide the catheters for interventional procedures, such as cardiac ablation. However, there are risks associated with this procedure, such as RF-induced heating of tissue near the catheters.

Construction and modeling of a reconfigurable MRI coil for lowering SAR in patients with deep brain stimulation implants.

Post-operative MRI of patients with deep brain simulation (DBS) implants is useful to assess complications and diagnose comorbidities, however more than one third of medical centers do not perform MRIs on this patient population due to stringent safety restrictions and liability risks. A new system of reconfigurable magnetic resonance imaging head coil composed of a rotatable linearly-polarized birdcage transmitter and a close-fitting 32-channel receive array is presented for low-SAR imaging of patients with DBS implants. The novel system works by generating a region with low electric field magnitude and steering it to coincide with the DBS lead trajectory.

Local SAR near deep brain stimulation (DBS) electrodes at 64 and 127 MHz: A simulation study of the effect of extracranial loops.

Purpose: MRI may cause brain tissue around deep brain stimulation (DBS) electrodes to become excessively hot, causing lesions. The presence of extracranial loops in the DBS lead trajectory has been shown to affect the specific absorption rate (SAR) of the radiofrequency energy at the electrode tip, but experimental studies have reported controversial results. The goal of this study was to perform a systematic numerical study to provide a better understanding of the effects of extracranial loops in DBS leads on the local SAR during MRI at 64 and 127 MHz.

Investigation of assumptions underlying current safety guidelines on EM-induced nerve stimulation.

An intricate network of a variety of nerves is embedded within the complex anatomy of the human body. Although nerves are shielded from unwanted excitation, they can still be stimulated by external electromagnetic sources that induce strongly non-uniform field distributions. Current exposure safety standards designed to limit unwanted nerve stimulation are based on a series of explicit and implicit assumptions and simplifications.

Feasibility of using linearly polarized rotating birdcage transmitters and close-fitting receive arrays in MRI to reduce SAR in the vicinity of deep brain simulation implants.

Purpose: MRI of patients with deep brain stimulation (DBS) implants is strictly limited due to safety concerns, including high levels of local specific absorption rate (SAR) of radiofrequency (RF) fields near the implant and related RF-induced heating. This study demonstrates the feasibility of using a rotating linearly polarized birdcage transmitter and a 32-channel close-fit receive array to significantly reduce local SAR in MRI of DBS patients.

Methods: Electromagnetic simulations and phantom experiments were performed with generic DBS lead geometries and implantation paths.