MR-guided focused ultrasound application for moving target tumor ablation in abdominal area: coil selection.

BACKGROUND: Magnetic Resonance Imaging (MRI)-guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive thermal ablation method utilizing high-intensity focused ultrasound (HI-FU) energy for tissue ablation under MRI with real-time thermal mapping. Ablating to a dynamic target as in the liver is very challenging, requiring approval. A novel quality-assured liver tumor ablation system has been proposed for clinics. The paper reports the evaluation of conventional and new MR-receiving coils. PURPOSE: To evaluate the suitability of MR coils as part of the MRgFUS treatment system for liver, while simulating breathing motion in pre-clinical settings. MATERIAL AND METHODS: The novel software communicates with the MR scanner and the transducer. To monitor the temperature via proton resonance frequency (PRF) methodology echo planar imaging (EPI) sequence was used while the algorithms of static, static and dynamic tracking were tested with sonications of 100 W for 30 s on tissue-mimicking phantoms. Different coil sets were used to assess the performance of the system for fitness for dynamic thermometry. Finally, in vivo experiments were performed over a porcine model. RESULTS: Single-loop four-channel Duoflex and Gem coils provided adequate signal-to-noise ratio and contrast with consistent thermal readings. Body array coils showed severe loss of signal in dynamic cases since the integration of tracking algorithm causes low efficiency. CONCLUSION: Body array coils are unsuitable for MRgFUS of the liver due to signal loss. The dedicated coil set with a single loop around the FUS transducer combined with four-channel arrays might be the best option for liver treatment using dynamic MRgFUS applications.

Wearable Motion Capture System Evaluation for Biomechanical Studies for Hip Joints.

Human motion capture (MOCAP) systems are vital while determining the loads occurring at the joints. Most of the clinical MOCAP systems are very costly, requiring investment and infrastructure. Therefore, alternative technologies are in demand. In this study, a novel markerless wearable MOCAP system was assessed for its compatibility with a biomechanical modeling software. To collect evidence, experiments were designed in two stages for quantifying the range of motion (ROM) of the hip joint, in vitro and in vivo. Three constrained single-plane motions-abduction/adduction, flexion/extension, and internal/external rotation movements of the active leg-were analyzed. The data were collected from 14 healthy volunteers, using the wearable system and a medical grade optoelectronic MOCAP system simultaneously and compared against. For the in vitro study, the root-mean-square error (RMSE) for the abduction/adduction motion of the hip joint was calculated as 0.11 deg/0.30 deg and 0.11 deg/0.09 deg, respectively, for the wearable and the opto-electronic system. The in vivo Bland-Altman plots showed that the two system data are comparable. The simulation software is found compatible to run the simulations in offline mode. The wearable system could be utilized in the field of biomechanics software for running the kinetic simulations. The results demonstrated that the wearable system could be an alternative in the field of biomechanics based on the evidence collected.

Reference-less MR thermometry on pre-clinical thiel human cadaver for liver surgery with MRgFUS.

PURPOSE: Reference-less MR thermometry can be a promising technique for temperature mapping during liver treatment with Magnetic Resonance-guided Focused Ultrasound (MRgFUS), as it is more robust to breathing motion than Proton Resonance Frequency MR thermometry. However, there is a lack of a pre-clinical model for repeatable testing of reference-less thermometry. The purpose of this work was to verify the explanted Thiel embalmed human liver and whole Thiel embalmed human cadaver for application of a custom made reference-less thermometry algorithm during MRgFUS sonication. MATERIAL AND METHODS: Phase maps were generated during sonication as an input to the algorithm. A square Region-of-Interest (ROI) was designed around the heated area. The ROI was interpolated using a two-dimensional polynomial to the surrounding phase map to calculate the background phase. RESULTS: Using the phase information from the images, the temperature rise was measured. Validation of the methodology showed accordance of temperatures with actual temperatures. CONCLUSIONS: The explanted liver and the whole cadaver constitute a promising and feasible model to study reference-less techniques for thermometry during MRgFUS, before clinical trials.

Principles of focused ultrasound.

Focused ultrasound (FUS/HIFU) relies on ablation of pathological tissues by delivering a sufficiently high level of acoustic energy in situ of the human body. Magnetic Resonance guided FUS (MRgFUS/HIFU) and Ultrasound guided (USgFUS/HIFU) are image guided techniques combined with therapeutic FUS for monitoring purposes. The principles and technologies of FUS/HiFU are described in this paper including the basics of MR guidance techniques and MR temperature mapping. Clinical applications of FUS/HIFU gained CE and FDA approvals for the treatment of various benign and few malignant lesions in the last two decades. Current technical limitations of ultrasound guided and MRI guided Focused Ultrasound, as well as adverse effects for the application of this technique are outlined including challenges of ablating moving organs (liver and kidney). An outlook to possible applications is provided; exampling clinical trials discussing future options.

Acoustic characterization of Thiel liver for magnetic resonance-guided focused ultrasound treatment.

BACKGROUND: The purpose of this work was to measure the essential acoustic parameters, i.e., acoustic impedance, reflection coefficient, attenuation coefficient, of Thiel embalmed human and animal liver. The Thiel embalmed tissue can be a promising, pre-clinical model to study liver treatment with Magnetic Resonance-guided Focused Ultrasound (MRgFUS). MATERIAL AND METHODS: Using a single-element transducer and the contact pulse-echo method, the acoustic parameters, i.e., acoustic impedance, reflection coefficient and attenuation coefficient of Thiel embalmed human and animal liver were measured. RESULTS: The Thiel embalmed livers had higher impedance, similar reflection and lower attenuation compared to the fresh tissue. CONCLUSIONS: Embalming liver with Thiel fluid affects its acoustic properties. During MRgFUS sonication of a Thiel organ, more focused ultrasound (FUS) will be backscattered by the organ, and higher acoustic powers are required to reach coagulation levels (temperatures >56 °C).

Evidence-based cross validation for acoustic power transmission for a novel treatment system.

INTRODUCTION: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice. MATERIALS AND METHODS: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation. RESULTS: Both systems proved to deliver the power within the accepted efficiency levels (70-90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05). CONCLUSIONS: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice.

Feasibility study of pre-clinical Thiel embalmed human cadaver for MR-guided focused ultrasound of the spine.

BACKGROUND: Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) is a non-invasive treatment option based on high acoustic absorption and minimal thermal conductivity of the bone to destroy nerves and reduce pain. There is lack of a preclinical validation tool with correct human anatomy. This work introduces usage of an ex-vivo Thiel embalmed human tissue model for preclinical verification of MRgFUS on intervertebral discs or bone metastases within the spinal body. MATERIAL AND METHODS: Thiel embalmed human cadaver was subjected to FUS sonication of the vertebra (with energies 250J, 420J, 600J) and the intervertebral disc (with energies 310J, 610J, 950J) of the lumbar spine for 20s of sonication under MR guidance. RESULTS: For the vertebra, maximum temperatures were recorded as 38 °C, 58.3 °C, 69 °C. The intervertebral disc reached maximum temperatures of 23.7 °C, 54 °C, 83 °C. The temperature measurements showed that the spinal canal and adjacent organs were not heated > 0.1 °C. CONCLUSIONS: A heating pattern that can induce thermal ablation was achieved in the vertebral body and the intervertebral disc. Adjacent structures and nerves were not heated in lethal levels. Thus, the Thiel embalmed human cadaver can be a safe and efficient model for preclinical study of application of MRgFUS on the upper lumbar spine.

Patient-specific finite element analysis for assessing hip fracture risk in aging populations.

The femur is one of the most important bone in the human body, as it supports the body's weight and helps with movement. The aging global population presents a significant challenge, leading to an increasing demand for artificial joints, particularly in knee and hip replacements, which are among the most prevalent surgical procedures worldwide. This study focuses on hip fractures, a common consequence of osteoporotic fractures in the elderly population. To accurately predict individual bone properties and assess fracture risk, patient-specific finite element models (FEM) were developed using CT data from healthy male individuals. The study employed ANSYS 2023 R2 software to estimate fracture loads under simulated single stance loading conditions, considering strain-based failure criteria. The FEM bone models underwent meticulous reconstruction, incorporating geometrical and mechanical properties crucial for fracture risk assessment. Results revealed an underestimation of the ultimate bearing capacity of bones, indicating potential fractures even during routine activities. The study explored variations in bone density, failure loads, and density/load ratios among different specimens, emphasizing the complexity of bone strength determination. Discussion of findings highlighted discrepancies between simulation results and previous studies, suggesting the need for optimization in modelling approaches. The strain-based yield criterion proved accurate in predicting fracture initiation but required adjustments for better load predictions. The study underscores the importance of refining density-elasticity relationships, investigating boundary conditions, and optimizing models throughin vitrotesting for enhanced clinical applicability in assessing hip fracture risk. In conclusion, this research contributes valuable insights into developing patient-specific FEM bone models for clinical hip fracture risk assessment, emphasizing the need for further refinement and optimization for accurate predictions and enhanced clinical utility.

Dynamic computational wear model of PEEK-on-XLPE bearing couple in total hip replacements.

Understanding wear mechanisms is a key factor to prevent primary failures causing revision surgery in total hip replacement (THR) applications. This study introduces a wear prediction model of (Polyetheretherketone) PEEK-on-XLPE (cross-linked polyethylene) bearing couple utilized to investigate the wear mechanism under 3D-gait cycle loading over 5 million cycles (Mc). A 32-mm PEEK femoral head and 4-mm thick XLPE bearing liner with a 3-mm PEEK shell are modeled in a 3D explicit finite element modeling (FEM) program. The volumetric and linear wear rates of XLPE liner per every million cycles were predicted as 1.965 mm3/Mc, and 0.0032 mm/Mc respectively. These results are consistent with the literature. PEEK-on-XLPE bearing couple exhibits a promising wear performance used in THR application. The wear pattern evolution of the model is similar to that of conventional polyethylene liners. Therefore, PEEK could be proposed as an alternative material to the CoCr head, especially used in XLPE-bearing couples. The wear prediction model could be utilized to improve the design parameters with the aim of prolonging the life span of hip implants.

Database covering the prayer movements which were not available previously.

Lower body implants are designed according to the boundary conditions of gait data and tested against. However, due to diversity in cultural backgrounds, religious rituals might cause different ranges of motion and different loading patterns. Especially in the Eastern part of the world, diverse Activities of Daily Living (ADL) consist of salat, yoga rituals, and different style sitting postures. A database covering these diverse activities of the Eastern world is non-existent. This study focuses on data collection protocol and the creation of an online database of previously excluded ADL activities, targeting 200 healthy subjects via Qualisys and IMU motion capture systems, and force plates, from West and Middle East Asian populations with a special focus on the lower body joints. The current version of the database covers 50 volunteers for 13 different activities. The tasks are defined and listed in a table to create a database to search based on age, gender, BMI, type of activity, and motion capture system. The collected data is to be used for designing implants to allow these sorts of activities to be performed.

Simultaneous validation of wearable motion capture system for lower body applications: over single plane range of motion (ROM) and gait activities.

Extracting data from {Zhu, 2019 #5} daily life activities is important in biomechanical applications to define exact boundary conditions for the intended use-based applications. Although optoelectronic camera-marker based systems are used as gold standard tools for medical applications, due to line-of-sight problem, there is a need for wearable, affordable motion capture (MOCAP) systems. We investigate the potential use of a wearable inertial measurement unit (IMU) based-wearable MOCAP system for biomechanical applications. The in vitro proof of concept is provided for the full lower body consisting of hip, knee, and ankle joints via controlled single-plane anatomical range of motion (ROM) simulations using an electrical motor, while collecting data simultaneously via opto-electronic markers and IMU sensors. On 15 healthy volunteers the flexion-extension, abduction-adduction, internal-external rotation (ROM) values of hip and, the flexion - extension ROM values of the knee and ankle joints are calculated for both systems. The Bland-Altman graphs showed promising agreement both for in vitro and in vivo experiments. The maximum Root Mean Square Errors (RMSE) between the systems in vitro was 3.4° for hip and 5.9° for knee flexion motion in vivo, respectively. The gait data of the volunteers were assessed between the heel strike and toe off events to investigate the limits of agreement, calculating the population averages and standard deviation for both systems over the gait cycle. The maximum difference was for the ankle joint <6°. The results show that proposed system could be an option as an affordable-democratic solution.

Finite Element Study of PEEK Materials Applied in Post-Retained Restorations.

BACKGROUND: This study aimed to investigate the biomechanical behaviors of polyether ether ketone (PEEK) and traditional materials (titanium and fiber) when used to restore tooth defects in the form of prefabricated post or customized post via computational modelling. METHODS: First, the prototype of natural tooth, and the prototypes of prefabricated post and customized post were established, respectively, whilst the residual root was restored with dentin ferrule using reverse engineering methods. Then, the stress and strain of CFR-PEEK (PEEK reinforced by 30% carbon fiber) and pure PEEK (PEEK without any reprocessing) post were compared with those made in traditional materials using the three-dimensional finite element method. RESULTS: From the stress point of view, compared with metal and fiber posts, CFR-PEEK and pure PEEK prefabricated post both demonstrated reduced post-core interface stress, post stress, post-root cement stress and root cement stress; moreover, CFR-PEEK and pure PEEK customized post demonstrated reduced post stress, post-root cement stress and root cement stress, while the strain of CFR-PEEK post was the closest to that of dentin. CONCLUSIONS: Compared with the traditional posts, both the CFR-PEEK and pure PEEK posts could reduce the risk of debonding and vertical root fracture, whether they were used as prefabricated posts or customized posts, but the biomechanical behavior of carbon fiber-reinforced CFR-PEEK restorations was the closest to dentin, no matter if they were used as prefabricated post or customized post. Therefore, the CFR-PEEK post could be more suitable to restore massive tooth defects. Pure PEEK needs filler reinforcement to be used for post-retained restoration.

Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation.

BACKGROUND AND OBJECTIVE: Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for liver tumour ablation is a challenging task due to motion caused by breathing and occlusion due the ribcage between the transducer and the tumour. To overcome these challenges, a novel system for liver tumour ablation during free breathing has been designed. METHODS: The novel TRANS-FUSIMO Treatment System (TTS, EUFP7) interacts with a Magnetic Resonance (MR) scanner and a focused ultrasound transducer to sonicate to a moving target in liver. To meet the requirements of ISO 13485; a quality management system for medical device design, the system needs to be tested for certain process parameters. The duration of sonication and, the delay after the sonication button is activated, are among the parameters that need to be quantified for efficient and safe ablation of tumour tissue. A novel methodology is developed to quantify these process parameters. A computerised scope is programmed in LabVIEW to collect data via hydrophone; where the coordinates of fiber-optic sensor assembly was fed into the TRANS-FUSIMO treatment software via Magnetic Resonance Imaging (MRI) to sonicate to the tip of the sensor, which is synchronised with the clock of the scope, embedded in a degassed water tank via sensor assembly holder. The sonications were executed for 50 W, 100 W, 150 W for 10 s to quantify the actual sonication duration and the delay after the emergency stop by two independent operators for thirty times. The deviation of the system from the predefined specs was calculated. Student's-T test was used to investigate the user dependency. RESULTS: The duration of sonication and the delay after the sonication were quantified successfully with the developed method. TTS can sonicate with a maximum deviation of 0.16 s (Std 0.32) from the planned duration and with a delay of 14 ms (Std 0.14) for the emergency stop. Student's T tests indicate that the results do not depend on operators (p > .05). CONCLUSION: The evidence obtained via this protocol is crucial for translation- of-research into the clinics for safe application of MRgFUS. The developed protocol could be used for system maintenance in compliance with quality systems in clinics for daily quality assurance routines.

A focused ultrasound treatment system for moving targets (part I): generic system design and in-silico first-stage evaluation.

BACKGROUND: Focused ultrasound (FUS) is entering clinical routine as a treatment option. Currently, no clinically available FUS treatment system features automated respiratory motion compensation. The required quality standards make developing such a system challenging. METHODS: A novel FUS treatment system with motion compensation is described, developed with the goal of clinical use. The system comprises a clinically available MR device and FUS transducer system. The controller is very generic and could use any suitable MR or FUS device. MR image sequences (echo planar imaging) are acquired for both motion observation and thermometry. Based on anatomical feature tracking, motion predictions are estimated to compensate for processing delays. FUS control parameters are computed repeatedly and sent to the hardware to steer the focus to the (estimated) target position. All involved calculations produce individually known errors, yet their impact on therapy outcome is unclear. This is solved by defining an intuitive quality measure that compares the achieved temperature to the static scenario, resulting in an overall efficiency with respect to temperature rise. To allow for extensive testing of the system over wide ranges of parameters and algorithmic choices, we replace the actual MR and FUS devices by a virtual system. It emulates the hardware and, using numerical simulations of FUS during motion, predicts the local temperature rise in the tissue resulting from the controls it receives. RESULTS: With a clinically available monitoring image rate of 6.67 Hz and 20 FUS control updates per second, normal respiratory motion is estimated to be compensable with an estimated efficiency of 80%. This reduces to about 70% for motion scaled by 1.5. Extensive testing (6347 simulated sonications) over wide ranges of parameters shows that the main source of error is the temporal motion prediction. A history-based motion prediction method performs better than a simple linear extrapolator. CONCLUSIONS: The estimated efficiency of the new treatment system is already suited for clinical applications. The simulation-based in-silico testing as a first-stage validation reduces the efforts of real-world testing. Due to the extensible modular design, the described approach might lead to faster translations from research to clinical practice.