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The InSightec Exablate system is the standard of care used for transcranial focused ultrasound ablation treatments in the United States. The system calculates phase corrections that account for aberrations caused by the human skull. This work investigates whether skull aberration correction can be improved by comparing the standard of care InSightec ray tracing method with the hybrid angular spectrum (HAS) method and the gold standard hydrophone method. Three degassed ex vivo human skulls were sonicated with a 670 kHz hemispherical phased array transducer (InSightec Exablate 4000). Phase corrections were calculated using four different methods (straight ray tracing, InSightec ray tracing, HAS, and hydrophone) and were used to drive the transducer. 3D raster scans of the beam profiles were acquired using a hydrophone mounted on a 3-axis positioner system. Focal spots were evaluated using six metrics: pressure at the target, peak pressure, intensity at the target, peak intensity, positioning error, and focal spot volume. For three skulls, the InSightec ray tracing method achieved 52 ± 21% normalized target intensity (normalized to hydrophone), 76 ± 17% normalized peak intensity, and 0.72 ± 0.47 mm positioning error. The HAS method achieved 74 ± 9% normalized target intensity, 81 ± 9% normalized peak intensity, and 0.35 ± 0.09 mm positioning error. The InSightec-to-HAS improvement in focal spot targeting provides promise in improving treatment outcomes. These improvements to skull aberration correction are also highly relevant for the applications of focused ultrasound neuromodulation and blood brain barrier opening, which are currently being translated for human use.

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OBJECTIVEThe authors evaluated the acoustic properties of an implantable, biocompatible, polyolefin-based cranial prosthesis as a medium to transmit ultrasound energy into the intracranial space with minimal distortion for imaging and therapeutic purposes.METHODSThe authors performed in vitro and in vivo studies of ultrasound transmission through a cranial prosthesis. In the in vitro phase, they analyzed the transmission of ultrasound energy through the prosthesis in a water tank using various transducers with resonance frequencies corresponding to those of devices used for neurosurgical imaging and therapeutic purposes. Four distinct, single-element, focused transducers were tested at fundamental frequencies of 500 kHz, 1 MHz, 2.5 MHz, and 5 MHz. In addition, the authors tested ultrasound transmission through the prosthesis using a linear diagnostic probe (center frequency 5.3 MHz) with a calibrated needle hydrophone in free water. Each transducer was assessed across a range of input voltages that encompassed their full minimum to maximum range without waveform distortion. They also tested the effect of the prosthesis on beam pressure and geometry. In the in vivo phase, the authors performed ultrasound imaging through the prosthesis implanted in a swine model.RESULTSAcoustic power attenuation through the prosthesis was considerably lower than that reported to occur through the native cranial bone. Increasing the frequency of the transducer augmented the degree of acoustic power loss. The degradation/distortion of the ultrasound beams passing through the prosthesis was minimal in all 3 spatial planes (XY, XZ, and YZ) that were examined. The images acquired in vivo demonstrated no spatial distortion from the prosthesis, with spatial relationships that were superimposable to those acquired through the dura.CONCLUSIONSThe results of the tests performed on the polyolefin-based cranial prosthesis indicated that this is a valid medium for delivering both focused and unfocused ultrasound and obtaining ultrasound images of the intracranial space. The prosthesis may serve for several diagnostic and therapeutic ultrasound-based applications, including bedside imaging of the brain and ultrasound-guided focused ultrasound cerebral procedures.

The theoretical and practical advantages of the flexible-leaflet prosthetic aortic valve make it worthy of continued development. Laboratory and clinical experience with a precision-molded, single-unit, tricuspid silicone rubber prosthesis suggest that the problems of materials, construction, and performance have been overcome. The use of a suitable elastomer in a precision casting with an anticlotting surface coating has resulted in a leaflet prosthesis the long-term functional performance of which should compare favorably with any device currently in use.