# US 11,027,149 B2 · Hybrid ultrasound-guided superficial radiotherapy system and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,149 B2 - Document ID: US11027149B2 - Status: Granted - Kind: B2 - Application number: 13/740,181 - Filed: 2013-01-12 - Published: 2013-08-22 - Granted: 2021-06-08 - Earliest claimed: 2012-01-12 - Assignees: Sensus Healthcare, Inc. - Applicants: Sensus Healthcare, Inc. - Inventors: Kalman Fishman - Web page: https://patentgrep.com/patent/US11027149B2 ## CPC - A61N 5/1039: {using functional images, e.g. PET or MRI} - A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules} - A61B 8/13: Tomography (A61B8/10, A61B8/12 take precedence) - A61B 8/483: {involving the acquisition of a 3D volume of data} - A61B 8/565: {involving data transmission via a network} - A61N 5/1049: {for verifying the position of the patient with respect to the radiation beam} - A61N 5/1077: {Beam delivery systems} - A61B 8/4405: {Device being mounted on a trolley} - A61B 8/466: {adapted to display 3D data} - A61N 2005/1058: {using ultrasound imaging} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Systems, method and devices for detecting, analyzing and treating lesions, such as skin cancer are disclosed. Such a system can include a high-frequency ultrasound imaging device to image a lesion. The system can also include a processor that executes instructions stored in memory to perform operations, and the operations can include receiving a plurality of images of the lesion from the high-frequency ultrasound imaging device, rendering a three dimensional model of the lesion using the plurality of images from the high-frequency ultrasound imaging device and determining a treatment dosimetry based on the three dimensional model of the lesion. The system can also include a radiotherapy device to provide radiotherapy treatment to the lesion, where the radiotherapy treatment is based on the treatment dosimetry. ## Claims ### Claim 1 A system for radiation treatment of skin lesions, comprising: a compact maneuverable base unit comprising at least one processor for performing data acquisition and processing operations to facilitate radiation therapy planning and treatment; a high-frequency ultrasound imaging device tethered to the base unit via a lead, the high frequency ultrasound imaging device configured to scan and acquire imaging data concerning the anatomy and topology of a patient's skin, and to communicate imaging data to the at least one processor, said high frequency ultrasound device configured to operate at an ultrasound frequency in the range of from 20 MHz to 70 MHz to facilitate imaging of a lesion present exclusively within at least one of a plurality of skin layers selected from the group consisting of the epidermis, dermis, and subcutaneous skin layers; the at least one processor configured to execute instructions stored in memory to perform operations, the operations comprising: receiving a plurality of two-dimensional image slices from the high-frequency ultrasound imaging device, each image slice extending through the plurality of skin layers; isolating the lesion within the skin layers including lesion edges in each of the plurality of two-dimensional image slices to yield a plurality of processed image slices; combining at least a portion of the plurality of processed image slices to render a three dimensional model of the lesion including the sub-surface portions of the lesion and sub-surface lesion edges contained within the plurality of skin layers; analyzing the three dimensional model of the lesion within the plurality of skin layers to determine lesion type, lesion volume, lesion edges and lesion depth; determining a treatment dosimetry based at least on the lesion type, lesion volume, lesion edges and lesion depth, the treatment dosimetry comprising dose energy level, dose amount, dose location and three dimensional dose boundaries defined within the plurality of skin layers; and a radiotherapy device mounted to the compact maneuverable base unit and operable under the control of the at least one processor, the radiotherapy device including a treatment arm and a treatment head, the treatment arm articulated to facilitate positioning of the treatment head at a location to provide radiotherapy treatment to the lesion based on the treatment dosimetry, and the treatment head responsive to the at least one processor to provide the radiotherapy treatment according to the dose energy level, dose amount, dose location and three-dimensional dose boundaries defined by the treatment dosimetry, the radiotherapy treatment comprising an x-ray beam, the x-ray beam having a source beam shape emanating from the treatment head; and at least one positioning system configured to obtain positioning data and to align the treatment head in accordance with the dose location and the three-dimensional dose boundaries for the lesion, the processor storing the positioning data and retrieving the positioning data such that the alignment of the treatment head can be reproduced during successive treatments. ### Claim 2 (depends on 1) The system of claim 1, further comprising; a camera coupled to the articulating arm; a laser pointer coupled to the radiotherapy device; and wherein the camera and laser pointer provide a video-laser positioning system. ### Claim 3 (depends on 1) The system of claim 1, further comprising: a solid-state x-ray detector array housed within the radiotherapy device to sense characteristics of radiation emitted by the x-ray tube. ### Claim 4 (depends on 3) The system of claim 3, wherein operations further comprise: testing the radiotherapy device with the solid-state x-ray detector array; determining characteristics of radiation emitted by the x-ray tube based on the testing of the radiotherapy device; and adjusting the radiotherapy device based on characteristics of the radiation emitted by the x-ray tube. ### Claim 5 (depends on 1) The system of claim 1, further comprising at least one template configured according to the treatment dosimetry to be placed over the lesion to confine the x-ray beam shape from the source beam shape emanating from the treatment head to a second, treatment beam shape different from the source beam shape. ### Claim 6 (depends on 5) The system of claim 5, wherein the template is configured to provide a treatment margin for applying the radiation to the lesion of between 10 and 15 percent. ### Claim 7 A system for use in radiation treatment of skin lesions present exclusively within at least one of a plurality of skin layers selected from the group consisting of the epidermis, dermis, and subcutaneous skin layers, comprising: a memory that stores instructions; and a processor that executes the instructions to perform operations, the operations comprising: receiving a plurality of two-dimensional image slices of a lesion from a high-frequency ultrasound imaging device, each image slice extending through the plurality of skin layers; isolating the lesion within the skin layers in each of the plurality of two-dimensional image slices to yield a plurality of processed images; combining at least a portion of the plurality of processed image slices to render a three dimensional model of the lesion, including the sub-surface portions of the lesion and sub-surface lesion edges contained within the plurality of skin layers; analyzing the three dimensional model of the lesion within the plurality of skin layers to determine lesion type, lesion volume, lesion edges and lesion depth; determining a treatment dosimetry based at least on the lesion type, lesion volume, lesion edges and lesion depth, the treatment dosimetry comprising dose energy level, dose amount, dose location and three-dimensional dose boundaries defined within the plurality of skin layers; and providing the treatment dosimetry for use with a radiotherapy device. ### Claim 8 (depends on 7) The system of claim 7, wherein the operations further comprise: receiving solid-state x-ray detector array testing data of the radiotherapy device; and determining characteristics of radiation emitted by the x-ray tube based on the testing of the radiotherapy device. ### Claim 9 (depends on 8) The system of claim 8, wherein the operations further comprise adjusting the radiotherapy device based on characteristics of the radiation emitted by the x-ray tube. ### Claim 10 (depends on 7) The system of claim 7, wherein the operations further comprise: analyzing a volume of the lesion after providing the treatment; and determining a treatment voxel for the volume with the lesion to be treated. ### Claim 11 A computer-readable device comprising instructions, which when executed by a processor, cause the processor to perform operations comprising: receiving a plurality of two-dimensional image slices of a skin lesion present exclusively within at least one of a plurality of skin layers selected from the group consisting of the epidermis, dermis, and subcutaneous skin layers, the image slices being received from a high-frequency ultrasound imaging device, each image slice extending through the plurality of skin layers; isolating the lesion within the skin layers in each of the plurality of two-dimensional image slices to yield a plurality of processed images; combining at least a portion of the plurality of processed image slices to render a three dimensional model of the lesion, including the sub-surface portions of the lesion and sub-surface lesion edges contained within the plurality of skin layers; analyzing the three dimensional model of the lesion within the plurality of skin layers to determine lesion type, lesion volume, lesion edges and lesion depth; determining a treatment dosimetry based at least on the lesion type, lesion volume, lesion edges and lesion depth, the treatment dosimetry comprising dose energy level, dose amount, dose location and three-dimensional dose boundaries defined within the plurality of skin layers; and providing the treatment dosimetry for use with a radiotherapy device. ### Claim 12 (depends on 11) The computer-readable device of claim 11, wherein the operations further comprise: receiving solid-state x-ray detector array testing data of the radiotherapy device; and determining characteristics of radiation emitted by the x-ray tube based on the testing data of the radiotherapy device. ### Claim 13 (depends on 12) The computer-readable device of claim 12, wherein the operations further comprise adjusting the radiotherapy device based on characteristics of the radiation emitted by the x-ray tube. ### Claim 14 (depends on 11) The computer-readable device of claim 11, wherein the operations further comprise determining a treatment voxel for a volume with the lesion to be treated. ### Claim 15 A method of treating a skin lesion, comprising: obtaining a plurality of two-dimensional image slices of a skin lesion present exclusively within at least one of a plurality of skin layers selected from the group consisting of the epidermis, dermis, and subcutaneous skin layers, the image slices being received from a high-frequency ultrasound imaging device, each image slice extending through the plurality of skin layers with a high-frequency ultrasound device; processing, by utilizing instructions stored in memory and executed by a processor, the plurality of two-dimensional image slices to isolate within the skin layers the lesion and yield a plurality of processed images; combining at least a portion of the plurality of processed image slices to render a three dimensional model of the lesion, including the sub-surface portions of the lesion and sub-surface lesion edges contained within the plurality of skin layers; analyzing the three dimensional model of the lesion within the plurality of skin layers to determine lesion type, lesion volume, lesion edges and lesion depth; determining a treatment dosimetry based at least on the lesion type, lesion volume, lesion edges and lesion depth, the treatment dosimetry comprising dose energy level, dose amount, dose location and three-dimensional dose boundaries defined within the plurality of skin layers; and providing a targeted radiotherapy to the lesion based on the treatment dosimetry, the targeted radiotherapy including the step of providing a radiotherapy device mounted to a compact maneuverable base unit and operable under the control of the at least one processor, the radiotherapy device including a treatment arm and a treatment head, the treatment arm articulated to facilitate positioning of the treatment head at a location to provide radiotherapy treatment to the lesion based on the treatment dosimetry, and the treatment head being responsive to the at least one processor to provide the radiotherapy treatment according to the dose energy level, dose amount, dose location and three-dimensional dose boundaries defined by the treatment dosimetry, the radiotherapy treatment comprising an x-ray beam, the x-ray beam having a source beam shape emanating from the treatment head. ### Claim 16 (depends on 15) The method of claim 15, further comprising: obtaining a plurality of post radiotherapy treatment images of the lesion with the high-frequency ultrasound device after providing the targeted radiotherapy to the lesion and during a treatment period of time; and providing further targeted radiotherapy to the lesion based on the plurality of post radiotherapy treatment images of the lesion; and providing at least one positioning system configured to obtain positioning data and to align the treatment head in accordance with the dose location and the three-dimensional dose boundaries for the lesion, the processor storing the positioning data and retrieving the positioning data such that the alignment of the treatment head can be reproduced during successive treatments. ### Claim 17 (depends on 15) The method of claim 15, further comprising: wherein providing a targeted radiotherapy to the lesion includes a plurality of sessions of providing the targeted radiotherapy to the lesion over the treatment period of time; analyzing topography of the lesion intermittently during the treatment period of time. ### Claim 18 (depends on 17) The method of claim 17, further comprising analyzing the lesion volume intermittently during the treatment period of time. ### Claim 19 (depends on 15) The method of claim 15, further comprising determining a treatment voxel for a volume with the lesion to be treated. ### Claim 20 (depends on 15) The method of claim 15, further comprising the step of providing at least one template configured according to the treatment dosimetry, and placing the template over the lesion to confine the x-ray beam shape from the source beam shape emanating from the treatment head to a second, treatment beam shape different from the source beam shape. ### Claim 21 (depends on 20) The method of claim 20, wherein the template is configured to provide a treatment margin for applying the radiation to the lesion of between 10 and 15 percent.