Acoustic MedSystems (United States)

To develop patient-specific 3D models using Finite-Difference Time-Domain (FDTD) simulations and pre-treatment planning tools for the selective thermal ablation of prostate cancer with interstitial ultrasound. This involves the integration with a FDA 510(k) cleared catheter-based ultrasound interstitial applicators and delivery system. A 3D generalized "prostate" model was developed to generate temperature and thermal dose profiles for different applicator operating parameters and anticipated perfusion ranges. A priori planning, based upon these pre-calculated lethal thermal dose and iso-temperature clouds, was devised for iterative device selection and positioning. Full 3D patient-specific anatomic modeling of actual placement of single or multiple applicators to conformally ablate target regions can be applied, with optional integrated pilot-point temperature-based feedback control and urethral/rectum cooling. These numerical models were verified against previously reported ex-vivo experimental results obtained in soft tissues. For generic prostate tissue, 360 treatment schemes were simulated based on the number of transducers (1-4), applied power (8-20 W/cm2), heating time (5, 7.5, 10 min), and blood perfusion (0, 2.5, 5 kg/m3/s) using forward treatment modelling. Selectable ablation zones ranged from 0.8-3.0 cm and 0.8-5.3 cm in radial and axial directions, respectively. 3D patient-specific thermal treatment modeling for 12 Cases of T2/T3 prostate disease demonstrate applicability of workflow and technique for focal, quadrant and hemi-gland ablation. A temperature threshold (e.g., Tthres = 52 °C) at the treatment margin, emulating placement of invasive temperature sensing, can be applied for pilot-point feedback control to improve conformality of thermal ablation. Also, binary power control (e.g., Treg = 45 °C) can be applied which will regulate the applied power level to maintain the surrounding temperature to a safe limit or maximum threshold until the set heating time. Prostate-specific simulations of interstitial ultrasound applicators were used to generate a library of thermal-dose distributions to visually optimize and set applicator positioning and directivity during a priori treatment planning pre-procedure. Anatomic 3D forward treatment planning in patient-specific models, along with optional temperature-based feedback control, demonstrated single and multi-applicator implant strategies to effectively ablate focal disease while affording protection of normal tissues.

Changes in ultrasound backscatter energy (CBE) imaging can monitor thermal therapy. Catheter-based ultrasound (CBUS) can treat deep tumors with precise spatial control of energy deposition and ablation zones, of which CBE estimation can be limited by low contrast and robustness due to small or inconsistent changes in ultrasound data. This study develops a multi-spatiotemporal compounding CBE (MST-CBE) imaging approach for monitoring specific to CBUS thermal therapy. Ex vivo thermal ablations were performed with stereotactic positioning of a 180° directional CBUS applicator, temperature monitoring probes, endorectal US probe, and subsequent lesion sectioning and measurement. Five frames of raw radiofrequency data were acquired throughout in 15s intervals. Using window-by-window estimation methods, absolute and positive components of MST-CBE images at each point were obtained by the compounding ratio of squared envelope data within an increasing spatial size in each short-time window. Compared with conventional US, Nakagami, and CBE imaging, the detection contrast and robustness quantified by tissue-modification-ratio improved by 37.2 ± 4.7 (p < 0.001), 37.5 ± 5.2 (p < 0.001), and 6.4 ± 4.0 dB (p < 0.05) in the MST-CBE imaging, respectively. Correlation coefficient and bias between cross-sectional dimensions of the ablation zones measured in tissue sections and estimated from MST-CBE were up to 0.91 (p < 0.001) and -0.02 mm2, respectively. The MST-CBE approach can monitor the detailed changes within target tissues and effectively characterize the dimensions of the ablation zone during CBUS energy deposition. The MST-CBE approach could be practical for improved accuracy and contrast of monitoring and evaluation for CBUS thermal therapy.

The purpose of this study is to investigate the feasibility and performance of a stationary, non-focused dual-sectored tubular transurethral ultrasound applicator for thermal exposure of tissue regions adjacent to the urethra for treatment of stress urinary incontinence (SUI) through acoustic and biothermal simulations on 3D anatomical models. Parametric studies in a generalized tissue model over dual-sectored ultrasound applicator configurations (acoustic surface intensities, lateral active acoustic output sector angles, and durations) were performed. Selected configurations and delivery strategies were applied on 3D pelvic anatomical models. Temperature and thermal dose distributions on the target region and surrounding tissues were calculated. Endovaginal cooling was explored as a strategy to mitigate vaginal heating. The 75-90° dual-sectored transurethral tubular transducer (3.5mm outer diameter (OD), 14mm length, 6.5MHz, 8.8-10.2W/cm2) and 2-3-min sonication duration were selected from the parametric study for acoustic and biothermal simulations on anatomical models. The transurethral applicator with two opposing 75-90° active lateral tubular sectors can create two heated volumes for a total of up to 1.8cm3 over 60 EM43°C, with at least 10mm radial penetration depth, 1.2mm urethral sparing, and no lethal damage to the vagina and adjacent bone (< 60 EM43°C). Endovaginal cooling can be applied to further reduce the vaginal wall exposure (< 15 EM43°C). Simulations on 3D anatomical models indicate that dual-sectored transurethral ultrasound applicators can selectively heat pelvic floor tissue lateral to the mid-urethra in short treatment durations, without damaging adjacent vaginal and bone tissues, as a potential alternative treatment option for stress urinary incontinence. Graphical abstract Schema for in silico investigation of transurethral ultrasound thermal therapy applicator for minimally invasive treatment of SUI.

Treatment of brain tumors requires high precision in order to ensure sufficient treatment while minimizing damage to surrounding healthy tissue. Ablation of such tumors using needle-based therapeutic ultrasound (NBTU) under real-time magnetic resonance imaging (MRI) can fulfill this need. However, the constrained space and strong magnetic field in the MRI bore restricts patient access limiting precise placement of the NBTU ablation tool. A surgical robot compatible with use inside the bore of an MRI scanner can alleviate these challenges. We present preclinical trials of a robotic system for NBTU ablation of brain tumors under real-time MRI guidance. The system comprises of an updated robotic manipulator and corresponding control electronics, the NBTU ablation system and applications for planning, navigation and monitoring of the system. The robotic system had a mean translational and rotational accuracy of 1.39 ±0.64mm and 1.27[Formula: see text] in gelatin phantoms and 3.13 ±1.41mm and 5.58[Formula: see text] in 10 porcine trials while causing a maximum reduction in signal to noise ratio (SNR) of 10.3%. The integrated robotic system can place NBTU ablator at a desired target location in porcine brain and monitor the ablation in realtime via magnetic resonance thermal imaging (MRTI). Further optimization of this system could result in a clinically viable system for use in human trials for various diagnostic or therapeutic neurosurgical interventions.

We present a robotic system for transrectal ultrasound-guided prostate brachytherapy that employs a quick release mechanism to enable multiple needles to be inserted into the prostate prior to plan optimization. The mechanism consists of two actuated fingers that act as needle guides, thereby allowing insertion of both parallel and angled needles. Path planning, including reordering of needles within a batch, is required to avoid collisions with previously inserted needles. We perform two phantom experiments using clinical implant plans. The extra time required for the robotic motions, including finger actuation, is less than three minutes for the entire procedure. Mean position error is measured to be less than 0.5 mm, presumably due to the design of the needle guides, which have a toroidal shape to enable needle angulation.

Rapid advances in science and technology are opening doors for the fulfillment of human desires in ways that were not previously possible. Neural, genetic, pharmacological, and physical forms of augmentation of the human experience promise to multiply both in number and complexity over the next decades. It is our responsibility to create a public, open discourse around the ethical implications of technology that will shape what it means to be human in the near and distant future.

Purpose:High‐intensity focused ultrasound (HIFU) ablation is feasible in the head and neck [1]. This study aims to expand upon these findings to assess the feasibility of treatment planning and monitoring via magnetic resonance imaging (MRI) guidance using a clinical MR‐guided HIFU platform.Methods:Two 31 kg pigs were anaesthetized, shaved, and positioned prone on the HIFU table (Sonalleve, Philips Healthcare, Vantaa, Finland). The necks were acoustically coupled to the integrated transducer using gel pads and degassed water. MR imaging verified acoustic coupling and facilitated target selection in the thyroid and thymus. Targets were thermally ablated with 130–200 W of acoustic power over a period of 16 s at a frequency of 1.2 MHz while being monitored through real‐time, multi‐planar MR‐thermometry. Contrast‐enhanced MR imaging was used to assess treatment efficacy. Post‐treatment, animals were euthanized and sonicated tissues were harvested for histology assessment.Results:MR‐thermometry, post‐contrast‐imaging, and gross pathology demonstrated that the system was capable of causing localized thermal ablation in both the thyroid and the thymus without damaging the aerodigestive tract. In one animal, superficial bruising was observed in the ultrasound beam path. Otherwise, there were no adverse events. Analysis of the tissue histology found regions of damage consistent with acute thermal injury at the targeted locations.Conclusion:It is feasible to use a clinical MR‐guided HIFU platform for extracorporeal ablation of porcine head and neck tissues. MR guidance and thermometry are sufficient to target and monitor treatment in the thyroid region, despite the presence of the inhomogeneous aerodigestive tract. Further study is necessary to assess efficacy and survival using a tumor model, and to examine what modifications should be made to the transducer positioning system and associated patient positioning aids to adapt it for clinical head and neck targets.Reference:[1] Esnault et al. (2011). Thyroid, 21(9), 965– 973.Funding support provided by Philips Healthcare. Ari Partanen is a paid employee of Philips Healthcare.

The success of any minimally invasive treatment procedure can be enhanced significantly if combined with a robust noninvasive quantitative imaging modality. Quantitative ultrasound (QUS) imaging has been widely investigated for monitoring various treatment responses such as chemotherapy and thermal therapy. Previously we have shown the feasibility of using spectral based quantitative ultrasound parameters to monitor high-intensity focused ultrasound (HIFU) treatment of in situ tumors [Ultrasonic Imaging, 2014]. In the present study we examined the use the various QUS parameters to monitor HIFU treatment of an in vivo mouse mammary adenocarcinoma model. Spectral parameters in terms of the backscatter coefficient, integrated backscattered energy, attenuation coefficient, and effective scatterer size and concentration were estimated from radiofrequency signals during the treatment. The characteristic of each parameter was compared to the temperature profile recorded by needle thermocouple inserted into the tumor a few millimeters away from the focal zone of the intersecting HIFU and the imaging transducer beams. The changes in the QUS parameters during the HIFU treatment followed similar trends observed in the temperature readings recorded from the thermocouple. These results suggest that QUS techniques have the potential to be used for non-invasive monitoring of HIFU exposure.