US-20260123882-A1 - PATIENT-SPECIFIC HEADSET FOR DIAGNOSTIC AND THERAPEUTIC TRANSCRANIAL PROCEDURES

US20260123882A1US 20260123882 A1US20260123882 A1US 20260123882A1US-20260123882-A1

Abstract

Systems, methods and devices are provided for performing diagnostic or therapeutic transcranial procedures using a patient-specific transcranial headset. The patient-specific headset may include a patient-specific frame that is fabricated, according to volumetric image data, to conform to an anatomical curvature of a portion of a patient's head. The patient-specific frame is configured to support a plurality of transducers in pre-selected positions and orientations, which may be spatially registered to the volumetric image data. This spatial registration may be employed to control at least a portion of the transducers to focus energy at a pre-selected tissue region.

Inventors

Kullervo Henrik Hynynen

Assignees

Sunnybrook Research Institute

Dates

Publication Date: 20260507
Application Date: 20250929

Claims (20)

1 - 51 . (canceled)
52 . A system for performing diagnostic or therapeutic transcranial procedures, the system comprising: a patient-specific frame customized to specifically fit a head of a patient, such that when the patient-specific frame is placed on the head of the patient, the patient specific frame conforms to an anatomical contour of at least a portion of the head of the patient; the patient-specific frame comprising a plurality of ultrasound transducer attachment interfaces such that, when each ultrasound transducer attachment interface has a respective ultrasound transducer attached thereto and the patient-specific frame is worn by the patient, the plurality of ultrasound transducers respectively attached to the plurality of ultrasound transducer attachment interfaces reside in predetermined positions and orientations relative to the head of the patient as prescribed by transducer registration data spatially registering the plurality of ultrasound transducers with a frame of reference of volumetric image data associated with the patient; the system further comprising a data storage medium storing the transducer registration data.
53 . The system according to claim 52 further comprising the plurality of ultrasound transducers, each ultrasound transducer being removably attachable to a respective ultrasound transducer attachment interface.
54 . The system according to claim 53 wherein all of the plurality of ultrasound transducers are detached from the plurality of ultrasound transducer attachment interfaces.
55 . The system according to claim 53 wherein each ultrasound transducer of the plurality of ultrasound transducers is attached to a respective ultrasound transducer attachment interface.
56 . The system according to claim 52 wherein each ultrasound transducer attachment interface comprises a respective aperture configured to receive a respective ultrasound transducer.
57 . The system according to claim 52 wherein each ultrasound transducer attachment interface comprises a respective recess configured to receive a respective ultrasound transducer of the plurality of ultrasound transducers.
58 . The system according to claim 55 further comprising control and processing hardware operably connected to the plurality of ultrasound transducers, the control and processing hardware being configured to employ the transducer registration data to control at least a portion of the ultrasound transducers to focus energy, within the head of the patient, at a pre-selected tissue region defined relative to the volumetric image data.
59 . The system according to claim 58 wherein the control and processing hardware is further configured to: control a subset of the plurality of ultrasound transducers to measure, for each ultrasound transducer of the subset of ultrasound transducers, a spatial offset of a skull of the patient relative to the patient-specific frame; and employ the spatial offsets to correct a spatial registration of the plurality of ultrasound transducers relative to the pre-selected tissue region.
60 . The system according to claim 53 wherein at least one ultrasound transducer of the plurality of ultrasound transducers is an ultrasound transducer module comprising a sub-array of ultrasound transducer elements.
61 . The system according to claim 60 wherein each ultrasound transducer module has a unique shape, such that a given ultrasound transducer module fits uniquely with a corresponding respective ultrasound transducer attachment interface.
62 . The system according to claim 53 wherein at least one ultrasound transducer of the plurality of ultrasound transducers is an imaging transducer configured to receive reflections from a skull of the patient.
63 . The system according to claim 52 wherein the plurality of ultrasound transducer attachment interfaces are supported such that the plurality of ultrasound transducers, when attached to the plurality of ultrasound transducer attachment interfaces, form a phased array.
64 . The system according to claim 63 wherein the pre-selected positions and orientations of the plurality of ultrasound transducers are selected to reduce grating lobes.
65 . The system according to claim 52 wherein the patient-specific frame further comprises a coupling layer, wherein the coupling layer is provided adjacent to an inner surface of the patient-specific frame such that when the patient-specific frame is worn, an outer surface of the coupling layer contacts distal surfaces of the plurality of ultrasound transducers, and an inner surface of the coupling layer is configured to contact the head of the patient, thereby facilitating coupling of energy between the patient-specific frame and the head of the patient.
66 . A method of fabricating a patient-specific frame for diagnostic or therapeutic procedures, the method comprising: obtaining surface data characterizing an anatomical curvature of at least a portion of a head of a patient; employing the surface data to generate a digital model of a patient-specific frame that conforms to the anatomical curvature of the head of the patient, the digital model of the patient-specific frame being generated such that the patient-specific frame comprises a plurality of ultrasound transducer attachment interfaces, each ultrasound transducer attachment interface being configured to support attachment of a respective ultrasound transducer of a plurality of ultrasound transducers; generating transducer registration data that spatially registers the plurality of ultrasound transducers, when the plurality of ultrasound transducers are attached to the plurality of ultrasound transducer attachment interfaces, with a frame of reference of volumetric image data associated with the patient; and fabricating the patient-specific frame according to the digital model.
67 . The method according to claim 66 further comprising attaching the plurality of ultrasound transducers to the plurality of ultrasound transducer attachment interfaces.
68 . The method according to claim 66 wherein the digital model of the patient-specific frame is modified such that the plurality of ultrasound transducers are removably attachable to the plurality of ultrasound transducer attachment interfaces.
69 . The method according to claim 66 wherein fabricating the patient-specific frame comprises 3D printing the patient-specific frame.
70 . The method according to claim 66 wherein fabricating the patient-specific frame comprises fabricating a mold and employing the mold to fabricate the patient-specific frame.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to U.S. Provisional Application No. 62/298,873, titled “PATIENT-SPECIFIC HEADSET FOR DIAGNOSTIC AND THERAPEUTIC TRANSCRANIAL PROCEDURES” and filed on Feb. 23, 2016, the entire contents of which is incorporated herein by reference. BACKGROUND The present disclosure relates to transcranial diagnostic and therapeutic procedures. The application of focused ultrasound to the brain through the intact skull has a long history leading up to the clinical implementations of the present day. Since the first successful ablation of animal brain tissue transcranially using a single transducer in 1980, to the present day multi-center clinical trials of Magnetic Resonance (MR)-guided focused ultrasound for the treatment of essential tremor using hemispherical phased arrays consisting of more than one thousand elements, new phased array designs have been conceptualized to overcome previous challenges, such as skull aberration correction, standing wave reduction, skull heating, and dual-frequency blood-brain barrier disruption. SUMMARY Systems, methods and devices are provided for performing diagnostic or therapeutic transcranial procedures using a patient-specific transcranial headset. The patient-specific headset may include a patient-specific frame that is fabricated, according to volumetric image data, to conform to an anatomical curvature of a portion of a patient's head. The patient-specific frame is configured to support a plurality of transducers in pre-selected positions and orientations, which may be spatially registered to the volumetric image data. This spatial registration may be employed to control at least a portion of the transducers to focus energy at a pre-selected tissue region. Accordingly, in a first aspect, there is provided a system for performing diagnostic or therapeutic transcranial procedures, the system comprising: a patient-specific transcranial headset comprising: a patient-specific frame configured to conform to an anatomical curvature of a portion of a patient's head, said patient-specific frame having been fabricated based on volumetric image data associated with the patient;a plurality of transducers supported by said patient-specific frame, wherein said plurality of transducers are supported in pre-selected positions and orientations relative to said patient-specific frame; and control and processing hardware operably connected to said plurality of transducers, wherein said control and processing hardware is configured to: obtain transducer registration data spatially registering the pre-selected positions and orientations of said plurality of transducers with the volumetric image data; andcontrol at least a portion of said plurality of transducers to focus energy at a pre-selected tissue region. In another aspect, there is provided a method of fabricating a transcranial headset for diagnostic or therapeutic procedures, the method comprising: obtaining, from volumetric image data of a patient's head, surface data characterizing an anatomical curvature of a portion of the patient's head;employing the surface data to generate a digital model of a patient-specific frame, such that the patient-specific frame conforms to the anatomical curvature of the portion of the patient's head;modifying the digital model such that the patient-specific frame comprises a plurality of transducer attachment interfaces for receiving and supporting a plurality of transducers in pre-selected positions and orientations relative to the patient's head;fabricating the patient-specific frame according to the digital model;securing the plurality of transducers to the transducer attachment interfaces; andgenerating transducer registration data characterizing the positions and orientations of the plurality of transducers relative to the volumetric image data. In another aspect, there is provided a kit for performing diagnostic or therapeutic transcranial procedures, the kit comprising: a patient-specific transcranial headset comprising: a patient-specific frame configured to conform to an anatomical curvature of a portion of a patient's head, said patient-specific frame having been fabricated based on volumetric image data associated with the patient;a plurality of transducers supported by said patient-specific frame, wherein said plurality of transducers are supported in pre-selected positions and orientations relative to said patient-specific frame; and transducer registration data spatially registering the pre-selected positions and orientations of said plurality of transducers with the volumetric image data. A further understanding of the functional and advantageous aspects of the disclosure can be realized by reference to the following detailed description and drawings. BRIEF DESCRIPTION OF THE DRAWINGS Embodiments will now be described, by way of example only, with reference to the drawings, in which: FIG.