Hands-free operator-independent transcranial ultrasound apparatus and methods
First Claim
1. An apparatus for non-invasive therapeutic application of transcranial ultrasound, which comprises:
- a) an adjustably tightenable circumcranial headset assembly configured with registration surfaces for engaging at least three external craniological landmarks of a skull so as to stereotactically position a headset assembly on said skull with respect to an intracranial target or targets;
said headset assembly including anterior and posterior headframe members configured to mate at corresponding ends of said members such as to define, when the headset assembly is positioned on the subject'"'"'s head for transcranial sonothrombolysis, a headset plane that is inclined with respect to a horizontal reference plane and is parallel to a plane of a subject'"'"'s Circle of Willis, so that said headset is raised above the eyes of said skull, has clearance around the ears of said skull, and engages an underside of a occipital protuberance of said skull when stereotactically positioned thereon,said headset assembly includinga nasion mounting registration bracket having a fixed end affixed to the headset assembly anteriorly at a midpoint at the front and a second end and protruding transversely to the headset plane and along the subject'"'"'s forehead such as to offset said midpoint of the headset by a height h1 with respect to the nasion, anda left (Lt) transducer-array registration bracket and a right (Rt) array-registration bracket slidably disposed contralaterally and removably on an internal surface of said headset assembly;
b) a plurality of transducer arrays, each said transducer array comprising a plurality of non-focused ultrasound transducers, wherein said transducers are mounted on said headset so as to be stereotactically directed at said target or targets without need for diagnostic imaging guidance;
said transducer arrays includingleft (Lt) and right (Rt) temporal transducer arrays aligned, respectively, by the Lt and Rt transducer-array registration brackets with an otobasion superior and a sphenoid shelf on the opposite sides of the subject'"'"'s head such as to optimize a degree of insonation of a target central cerebral vasculature with an ultrasound (US) beam emitted by said first transducer array, the insonation being directed substantially along the headset plane, anda posterior occipital transducer array disposed at a back portion of the headset such as to direct corresponding US beams at the basiliar and vertebral artery and a junction of an internal carotids of the Circle of Willis, andc) operatively attached to said headset, an electronic circuit with microcontroller, clock, memory, instruction set, a portable power and voltage supply, and on/off control for actuating said plurality of transducers in a repeating cycle, each cycle a metapulse comprising a plurality of trains of pulses, each train of pulses emitted intermittently and alternately at low duty cycle from selected transducers in a programmed sequence, whereby said skull is insonated with a stereotemporally modulated pattern of ultrasound without operator intervention and with low power consumption, the low duty cycle eliminating the need for assisted cooling.
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Accused Products
Abstract
Disclosed is a “hands-free”, autonomously operating, battery-powered apparatus with electronic programmable actuation circuitry for non-invasive ultrasonic treatment of ischemic stroke, microatheromas of the cerebral vasculature, intracranial hypertension, and other cerebrovascular pathologies such as hypoperfusion associated with migraine. The apparatus is provided with registration members to facilitate stereotactic placement of the headset on the skull with respect to target intracranial anatomy. Once fitted in place on the skull and activated, the device does not require clinical intervention during operation; does not need skilled technical adjustment of the waveform patterns; and achieves therapeutic results with power consumption of less than 400 mAmp-hr, thus permitting extended portable operation without external power and eliminating the need for assisted cooling. Using a device of the invention, transcranial ultrasound may be self-administered. The device has application in therapeutic methods, such as methods for treating stroke or migraine, for non-invasively augmenting drug action, and for release or dispersal of endogenous neurovascular mediators.
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Citations
27 Claims
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1. An apparatus for non-invasive therapeutic application of transcranial ultrasound, which comprises:
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a) an adjustably tightenable circumcranial headset assembly configured with registration surfaces for engaging at least three external craniological landmarks of a skull so as to stereotactically position a headset assembly on said skull with respect to an intracranial target or targets; said headset assembly including anterior and posterior headframe members configured to mate at corresponding ends of said members such as to define, when the headset assembly is positioned on the subject'"'"'s head for transcranial sonothrombolysis, a headset plane that is inclined with respect to a horizontal reference plane and is parallel to a plane of a subject'"'"'s Circle of Willis, so that said headset is raised above the eyes of said skull, has clearance around the ears of said skull, and engages an underside of a occipital protuberance of said skull when stereotactically positioned thereon, said headset assembly including a nasion mounting registration bracket having a fixed end affixed to the headset assembly anteriorly at a midpoint at the front and a second end and protruding transversely to the headset plane and along the subject'"'"'s forehead such as to offset said midpoint of the headset by a height h1 with respect to the nasion, and a left (Lt) transducer-array registration bracket and a right (Rt) array-registration bracket slidably disposed contralaterally and removably on an internal surface of said headset assembly; b) a plurality of transducer arrays, each said transducer array comprising a plurality of non-focused ultrasound transducers, wherein said transducers are mounted on said headset so as to be stereotactically directed at said target or targets without need for diagnostic imaging guidance; said transducer arrays including left (Lt) and right (Rt) temporal transducer arrays aligned, respectively, by the Lt and Rt transducer-array registration brackets with an otobasion superior and a sphenoid shelf on the opposite sides of the subject'"'"'s head such as to optimize a degree of insonation of a target central cerebral vasculature with an ultrasound (US) beam emitted by said first transducer array, the insonation being directed substantially along the headset plane, and a posterior occipital transducer array disposed at a back portion of the headset such as to direct corresponding US beams at the basiliar and vertebral artery and a junction of an internal carotids of the Circle of Willis, and c) operatively attached to said headset, an electronic circuit with microcontroller, clock, memory, instruction set, a portable power and voltage supply, and on/off control for actuating said plurality of transducers in a repeating cycle, each cycle a metapulse comprising a plurality of trains of pulses, each train of pulses emitted intermittently and alternately at low duty cycle from selected transducers in a programmed sequence, whereby said skull is insonated with a stereotemporally modulated pattern of ultrasound without operator intervention and with low power consumption, the low duty cycle eliminating the need for assisted cooling. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An apparatus for transcranial sonothrombolysis of a targeted cerebral vasculature of a subject'"'"'s head, the apparatus comprising:
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a set of transducer arrays; and a headset supporting said set of transducer arrays and mountable on the subject'"'"'s head, said headset including anterior and posterior headframe members configured to mate at corresponding ends of said members such as to define, when the headset is positioned on the subject'"'"'s head for transcranial sonothrombolysis, (i) a headset plane that is inclined with respect to a horizontal reference plane and is parallel to a plane of the subject'"'"'s Circle of Willis, and (ii) a circumcranial loop of said headset, wherein mutual positioning of the anterior and posterior headframe members is tensionally adjustable, said headset and including one or more mounting registration brackets adapted to stereotactically cooperate with the subject'"'"'s head such as to align transducer arrays from said set of transducer arrays with corresponding transcranial acoustic windows of the subject'"'"'s head when the headset is positioned on the subject'"'"'s head for transcranial sonothrombolysis, and to optimize an insonation of a targeted cerebral vasculature through said transcranial acoustic windows with ultrasound (US) beams emitted by said transducer arrays in such stereotactically cooperated position, wherein a nasion mounting registration bracket, from one or more mounting registration brackets, has a fixed end affixed to the headset at the front and a second end and protrudes transversely to the headset plane and along the subject'"'"'s forehead, wherein a first transducer-array registration bracket and a second array-registration bracket align, respectively, first and second temporal transducer arrays, from the set of transducer arrays, with an otobasion superior and a sphenoid shelf on the opposite sides of the subject'"'"'s head such as to optimize a degree of insonation of a target central cerebral vasculature with an ultrasound (US) beam emitted by said first transducer array, the insonation being directed substantially along the headset plane, wherein a posterior occipital transducer array, from the set of transducer arrays, is disposed at a back portion of the headset such as to direct corresponding US beams at the basiliar and vertebral artery and a junction of an internal carotids of the Circle of Willis, and wherein said nasion and first transducer-array registration brackets are configured such that, when the headset is positioned on the subject'"'"'s head for transcranial sonothrombolysis, said first transducer-array registration bracket aligns said first temporal transducer array with an otobasion superior and a sphenoid shelf without a need for measuring or locating of said otobasion superior and sphenoid shelf prior to positioning of the headset on the subject'"'"'s head. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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25. A headset apparatus for providing transcranial sonothrombolysis of a target cerebral vasculature of a subject'"'"'s head, comprising
(i) a processor; -
(ii) a non-transitory tangible computer-readable medium; (iii) computer-readable program code encoded in said computer-readable medium; (iv) an ultrasound (US) device that has a headset plane and includes mounting registration brackets, defined with respect to corresponding external craniological marks of the subject'"'"'s head, and a set of transducer arrays, said ultrasound device being positionable onto the subject'"'"'s head such that the mounting registration brackets are brought into contact with respectively corresponding external craniological marks and the headset plane is placed at an angle with respect to a horizontal reference plane that is defined by said external craniological marks and parallel to a plane of the subject'"'"'s Circle of Willis, wherein a nasion mounting registration bracket has a fixed end affixed to the headset at the front and a second end and protrudes transversely to the headset plane and along the subject'"'"'s forehead, a first transducer-array registration bracket and a second array-registration bracket align, respectively, first and second temporal transducer arrays, from the set of transducer arrays, with an otobasion superior and a sphenoid shelf on the opposite sides of the subject'"'"'s head such as to optimize a degree of insonation of a target central cerebral vasculature with an ultrasound (US) beam emitted by said first transducer array, the insonation being directed substantially along the headset plane, and a posterior occipital transducer array, from the set of transducer arrays, is disposed at a back portion of the headset such as to direct corresponding US beams at the basiliar and vertebral artery and a junction of an internal carotids of the Circle of Willis, wherein said nasion and first transducer-array registration brackets are configured such that, when the headset is positioned on the subject'"'"'s head for transcranial sonothrombolysis, said first transducer-array registration bracket aligns said first temporal transducer array with the otobasion superior and the sphenoid shelf without a need for measuring or locating of said otobasion superior and sphenoid shelf prior to positioning of the headset on the subject'"'"'s head; wherein the computer readable program code comprises a series of computer readable program steps to effect; insonating, in the headset plane, the target cerebral vasculature; and defining a regime of operation of the at least one of said transducer arrays. - View Dependent Claims (26, 27)
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Specification