Abstract: Transcranial ultrasound systems (TUS) and methods use domain-specific large vision models (DSLVM) artificial intelligence systems to improve the efficacy of non-imaging probes. A positioning DSLVM assists an operator in improving the placement of the probe on a patient’s head. The positioning DSLVM uses a pre-procedure MRI of the patient’s head, target dose plan, target anatomy, and the probe’s position information on the scalp, and it outputs the control parameters for the probe’s beamformer. A segmenting DSLVM helps an operator with the optimal initial placement of the non-imaging probe by highlighting anatomical structures in color.

Abstract: Systems and methods for safety assessment before and during a transcranial ultrasound (TUS) procedure are described. A neuronavigation system is used to determine the probe's position and orientation. The probe's location and the subject's head MRI data are used to simulate the acoustic field within the subject's head. The acoustic field is overlaid on the MRI data and displayed to a clinician for evaluation. The phases of the transmit voltages are adjusted to optimize the location of the peak of the acoustic field to match the targets in the subject's brain. Before and during TUS, the spatial distribution of tissue temperature, MI, TIC, and ISPTA are computed and displayed to the clinician. Acoustic field changes due to the subject's movement are detected, and the TUS operation is terminated if the stimulated acoustic field becomes off-target. Monitoring circuits shut down the neuromodulation if parameters are out-of-range.

Abstract: A medical ultrasonic system employs an artificial intelligence large vision model (LVM) trained on a database of target anatomy. The system employs an ultrasound probe and a neuromodulation beamformer plus additional instrumentation, all interfaced directly or indirectly to the domain specific large vision model (DSLVM). The system is configured to operate using volume ultrasound imaging or slice ultrasound imaging of the target anatomy. Examples are described for the cranial anatomy.

Abstract: Cranial acoustic coupling apparatuses and methods to improve coupling to the head for use in transcranial focused ultrasound systems (tFUS) are disclosed. The apparatuses are constructed using multiple components and layers to reduce the air gaps due to head curvature and smaller-scale features such as dimples, hair, and so on. An apparatus or system can include a holder unit and an attachment puck. The holder unit can include one or more ultrasound transducers. The attachment puck can include an attachment layer that interfaces with a head.

Abstract: Systems and methods use the anatomy of the target brain region to suggest waveforms for optimal stretching of the target tissue for neuromodulation. Cell orientation, white matter tracts, or direction of connection between brain regions of the target region are considered. The timing of waveforms generated is based on time constants relevant to the target brain region and structures. The System can lock into the phase and frequency of the target using physiological measurements provided by EEG or other physiological signals. The system provides recommendations on the number of transducers to use, the placement of the transducers, and other ultrasound stimulation parameters. In an embodiment, the system generates waveforms where the spatial derivates of pressure are maximized to improve the efficacy of the stimulation.

Abstract: Cranial acoustic coupling apparatuses and methods to improve coupling to the head for use in transcranial focused ultrasound systems (tFUS) are disclosed. The apparatuses are constructed using multiple components and layers to reduce the air gaps due to head curvature and smaller-scale features such as dimples, hair, and so on. An apparatus or system can include a holder unit and an attachment puck. The holder unit can include one or more ultrasound transducers. The attachment puck can include an attachment layer that interfaces with a head.

Abstract: Cranial acoustic coupling apparatuses and methods to improve coupling to the head for use in transcranial focused ultrasound systems (tFUS) are disclosed. The apparatuses are constructed using multiple components and layers to reduce the air gaps due to head curvature and smaller-scale features such as dimples, hair, and so on. An apparatus or system can include a holder unit and an attachment puck. The holder unit can include one or more ultrasound transducers. The attachment puck can include an attachment layer that interfaces with a head.

Abstract: A transcranial ultrasound headset can hold one or more transducer probe assemblies. The headset can be adjusted to match various human head sizes to securely place the ultrasound probe assemblies on the target areas of a patient's head. In an embodiment, transducer probe assemblies can be placed over a patient's left and right temporal areas, and a third transducer can be placed over the patient's inion. Design techniques and construction materials ensure that transducer probe assemblies are held securely during a transcranial ultrasound session while enhancing patient comfort. An adjustable headband strap around the head is attached to a forehead assembly. The headband strap supports one or more rings. Rings hold ultrasound probe assemblies. The forehead assembly supports pre-built settings for quick size adjustment, allowing rings to be positioned over target areas. An adjustable top strap and chin strap provide additional stability and size customization.

Abstract: A TUS (transcranial ultrasound) system with a matrix array transducer in a wearable format is disclosed. The TUS system uses ASIC (application-specific integrated circuit) and MEMS (micro-electromechanical system) technologies to achieve power, size, and weight reductions, allowing the device to be worn. In an embodiment, the TUS system can reliably find a target anatomical structure and remain locked onto the target throughout usage. All real-time tasks are controlled locally within the TUS system for a closed-loop operation. Safeguards enable subjects to use the system at home for medical treatment and wellness usage, as well as in a clinic. A method for using the system is disclosed.

Abstract: tFUS delivery and tracking systems and methods assess target location accuracy and therapy efficacy by measuring the specific and predicted downstream effects in individualistic responses to tFUS waveforms. The downstream effects include physiological, stress, mood, movement, attention measurements, subjective reports, task-based performance, etc. The measurements are performed before, during, and between tFUS sessions intermixed with optional control periods or sessions. In an embodiment, when a target brain region does not offer any immediate readouts but is surrounded by regions that may, these latter regions can be used instead for triangulation or waveform optimization. Individual and group tracking methods help identify useful measurement modalities and the expected direction and magnitude of change in response to therapy. A method that enables individualized functional targeting in a non-clinical setting by optimizing cost and complexity is described.

Abstract: A cranial probe assembly comprises an ultrasound transducer packaged into a probe. A stable probe holder in the form of a fixed ring is positioned on a patient's head. The position of the probe relative to the patient's head is adjustable with five degrees of freedom comprising cartesian coordinates x and y, the z-axis normal to the probe, and two orientation angles orthogonal to the z-axis. The adjustments assure the efficacy of an ultrasound procedure.

Abstract: Transcranial ultrasound systems (TUS) and methods use domain-specific large vision models (DSLVM) artificial intelligence systems to improve the efficacy of non-imaging probes. A positioning DSLVM assists an operator in improving the placement of the probe on a patient's head. The positioning DSLVM uses a pre-procedure MRI of the patient's head, target dose plan, target anatomy, and the probe's position information on the scalp, and it outputs the control parameters for the probe's beamformer. A segmenting DSLVM helps an operator with the optimal initial placement of the non-imaging probe by highlighting anatomical structures in color.

Abstract: System and methods utilizing specialized hardware and transactions with a public blockchain protect a medical or treatment device from misuse or malicious alteration. The blockchain allows treatments to be immutably published as readable specifications or in an encrypted format. The device will not start to function without a valid interaction with the blockchain. Patient identification, treatment authorization by a healthcare provider, and payment for services are also enabled by this system.

Abstract: A medical ultrasonic system employs an artificial intelligence large vision model (LVM) trained on a database of target anatomy. The system employs an ultrasound probe and a neuromodulation beamformer plus additional instrumentation, all interfaced directly or indirectly to the domain specific large vision model (DSLVM). The system is configured to operate using volume ultrasound imaging or slice ultrasound imaging of the target anatomy. Examples are described for the cranial anatomy.

Abstract: Systems and methods for safety assessment before and during a transcranial ultrasound (TUS) procedure are described. A neuronavigation system is used to determine the probe's position and orientation. The probe's location and the subject's head MRI data are used to simulate the acoustic field within the subject's head. The acoustic field is overlaid on the MRI data and displayed to a clinician for evaluation. The phases of the transmit voltages are adjusted to optimize the location of the peak of the acoustic field to match the targets in the subject's brain. Before and during TUS, the spatial distribution of tissue temperature, MI, TIC, and ISPTA are computed and displayed to the clinician. Acoustic field changes due to the subject's movement are detected, and the TUS operation is terminated if the stimulated acoustic field becomes off-target. Monitoring circuits shut down the neuromodulation if parameters are out-of-range.

Abstract: A TUS (transcranial ultrasound) system with a matrix array transducer in a wearable format is disclosed. The TUS system uses ASIC (application-specific integrated circuit) and MEMS (micro-electromechanical system) technologies to achieve power, size, and weight reductions, allowing the device to be worn. In an embodiment, the TUS system can reliably find a target anatomical structure and remain locked onto the target throughout usage. All real-time tasks are controlled locally within the TUS system for a closed-loop operation. Safeguards enable subjects to use the system at home for medical treatment and wellness usage, as well as in a clinic. A method for using the system is disclosed.

Abstract: A transcranial Focused Ultrasound (tFUS) system employs a probe array for steering and focusing a neuromodulation beam, wherein the probe array comprises an array of piezo-electric elements and the size of each element is larger in elevation than in azimuth. A “fuel gauge” user interface is employed to assist in selecting optimal probe alignments. Guidance information is enhanced using optical data provided by a mobile device incorporating a camera or a LIDAR device. A simulated prediction of the ultrasound neuromodulation beam is overlayed on an image of the brain.

Abstract: Systems and methods using non-imaging transcranial focused ultrasound (tFUS) systems are described. Non-imaging annular and matrix probes with low element counts are used in the systems. In an embodiment, an infrared-based system is used to gather the ultrasound's position information on the scalp. The position information is used to simulate the spatial distribution of the ultrasound field of the ultrasound probes. The simulation output is overlaid with pre-procedure MRI data and displayed to a clinician. Measurements on the MRI data are used to compensate the beam formation for the acoustic behavior of the skull so that a desirable tFUS focal region is achieved. In a different embodiment, an optical system is used for gathering positional information.

Abstract: A transcranial focused ultrasound (tFUS) system treats and reduces brain damage in stroke, heart attack, and cardiac arrest patients. More generally, this tFUS system can also be used to treat neurotrauma where a physical issue can cause unhealthy neural activity changes (dysregulation), in particular over-excitation or excessive depolarization, that then leads to large-scale neural death or connectivity changes, potentially through a positive feedback loop in dysregulation. Thus, applications could include neurotrauma, including traumatic brain injury and concussions. The system allows for monitoring the efficacy of the treatment and adjusting the sonication parameters. The system integrates other diagnostic and treatment systems, such as MRI, fNIRS, hypothermic chamber, etc. A method utilizing a tFUS system treats and reduces brain damage in those suffering from stroke, heart attack, cardiac arrest, or neurotrauma.

Abstract: A transcranial Focused Ultrasound (tFUS) system uses a neural network to correct skull aberrations and maximizes the transmission of ultrasound waves through the skull. A method using supervised learning generates aberration correction parameters to be used by the receiver and transmitter of the tFUS system. A method utilizing these aberration correction parameters operating on the tFUS system maximizes the coherence of ultrasound waves passing through the skull. The method maximizes the amount of power transmitted through the skull, given a fixed maximum pressure (for example, determined by regulatory requirements).