System and methods for non-invasive localized tissue heating with image guidance

IN595520BActive Publication Date: 2026-07-15INDIAN INST OF TECH MADRAS +1
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Authority / Receiving Office
IN · IN
Patent Type
Patents
Current Assignee / Owner
INDIAN INST OF TECH MADRAS
Filing Date
2024-02-25
Publication Date
2026-07-15
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Abstract

SYSTEM AND METHODS FOR NON-INVASIVE LOCALIZED TISSUE HEATING WITH IMAGE GUIDANCE ABSTRACT OF THE DISCLOSURE The invention discloses a phased array applicator device (100,210) and system (200) for organ positioning and delivering targeted hyperthermia treatment to the organ usingultrasound providing image guided real-time temperature mapping. The system includes a platform (201), the phased array applicator device (210), mounted on an applicator positioning unit (220), the device comprising a hyperthermia applicator tank (211) integrated with a plurality of ultrasound transducers (212) to generate ultrasound imaging data, wherein the applicator tank has a plurality of patch antennas (213) adapted to hold a dielectric medium surrounding the organ to selectively deliver microwave hyperthermia to a target tissue therewithin. The invention further discloses a method (300) for optimizing organ position and providing image guided localized hyperthermia with real-time temperature mapping using ultrasound image data. The device, system and method may efficiently facilitate targeted heating of locally advanced breast cancer (LABC). FIG. 2
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Description

DESC:FORM 2THE PATENT ACT, 1970(39 of 1970)COMPLETE SPECIFICATION(See section 10, rule 13)TITLE: SYSTEM AND METHODS FOR NON-INVASIVE LOCALIZED TISSUE HEATING WITH IMAGE GUIDANCEINVENTORSARUNACHALAM, Kavitha -Citizen of IndiaCHOUDHARY, Rahul -Citizen of IndiaGUNASEKARAN, AishwaryaAISHWARYA G -Citizen of IndiaRAMU, Muthu Rattina Subash-Citizen of IndiaDepartment of Engineering DesignIndian Institute of Technology Madras (IIT Madras)Chennai-600036IndiaGANAPATHY, Jagan-Citizen of IndiaNAIR, Gautam M -Citizen of IndiaMorpho Innovations Pvt. Ltd.No.68 / 13, Nehru 4th Street, Kumarannagar, Padi, Chennai Chennai TN 600050APPLICANT(1) Indian Institute of Technology Madras (IIT Madras)Office of the Dean ICSR, IIT Madras, IIT PO, Sardar Patel RoadChennai – 600036, India(2) Morpho Innovations Pvt. Ltd.No.68 / 13, Nehru 4th Street, Kumarannagar, Padi, Chennai 600050THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMEDSYSTEM AND METHODS FOR NON-INVASIVE LOCALIZED TISSUE HEATING WITH IMAGE GUIDANCECROSS-REFERENCES TO RELATED APPLICATIONS This application is a complete specification of provisional patent application no. 202441005066 entitled SYSTEM AND METHODS FOR NON-INVASIVE LOCALIZED TISSUE HEATING WITH IMAGE GUIDANCE filed on 25 February, 2024.FIELD OF THE INVENTION The invention generally relates tothermal therapy and in particular to biomedical devices and methods for noninvasive hyperthermia treatment.DESCRIPTION OF THE RELATED ART Microwave hyperthermia treatment (HT) is clinically being used as an adjuvant to chemotherapy and radio-therapy to treat cancer. During HT tumor temperature is elevated in the range of 40-44 °C for a duration of 60 minutes. The rationale behind HT as an adjuvant to standard cancer treatment modalities is well established and many clinical trials have shown promising results. Breast cancer is the most prevalent cancer in Indian women also one of the main causes of deaths due to cancer in Indian women [3]. Early detection is gaining importance as small localized tumour can be managed effectively using a combination of surgery, radiotherapy and chemotherapy. Lumpectomy (breast conserving surgery) is a surgery to remove the cancerous tumor when tumor size is less than 40 mm. More than half of the patient diagnosed with breast cancer due to late diagnosis have locally advanced breast cancer (LABC), where size of the tumor is greater than or equal to 50 mm in the absence of distant metastasis [4]. HT of deep seated tumors using a phased antenna array has shown promising results for targeted heating to tumor with minimal healthy tissue dose [5]. Phased array applicators are multi-antenna systems which achieve targeted elevation of tumor temperature by inducing constructive interference of the electromagnetic waves at the tumor region and destructive interference of the electromagnetic waves at healthy tissue region. Many phased array applicators have been proposed for HT of breast cancer [6-11]. All phased array applicators reported for microwave hyperthermia treatment of breast cancer consists of antennas arranged in multiple rings inside a tank which has temperature controlled de-ionized water or other coupling dielectric medium. The dielectric medium surrounding the pendant breast couples the radiated electromagnetic (EM) wave to the tissue and acts as a coolant for the antennas and skin. But none of the proposed applicators for breast cancer offers a complete clinical treatment setup consisting of a patient bed with the applicator, water circulation system and microwave power delivery for targeted heating of breast cancer tumor in the intact breast. Furthermore, most of the microwave hyperthermia devices for breast cancer employ antennas operating above 900 MHz that are capable of creating focal size less than 2 cm, which is not sufficient for treatment of LABC. LABC patients and patients with inoperable breast cancer are treated with neoadjuvant chemotherapy for tumor down sizing as the maximal tumor dimensions are more than 5 cm. Focal spot needed for hyperthermia treatment of LABC requires antennas operating at lower frequency. Thus, we propose use of phased array of antennas dielectric loaded near field patch antennas at 433 MHz (single frequency) for LABC. Phased array of antennas operating at 140 or 100 MHz which is radiofrequency (RF) provide regional heating which is not suited for targeted heating of LABC (patents). US patent US 2004 / 0230263 A1 proposes a breast applicator operating at 140 MHz employing folded bowtie / dipole antennas (4 to 6 numbers) with coaxial RF balun for regional heating of the breast with the breast in pendant position in a water tank. US patents 4,589,423 and US 2011 / 0245900 A1 are on hyperthermia abdomen treatment device employing folded dipole antennas with coaxial RF balun. US patent application US 2023 / 0028487 A1 is on microwave thermal therapy device operating over 1-3 GHz with 32 monopole broadband antennas used for delivering focused microwave therapy with focal spot of up to 2 cm and is proposed for tumor downsizing done prior to breast conversation surgery. The apparatus has broad band horn (1-3 GHz) for emanating high power pulse to the breast pendant in a dielectric liquid (castor oil) for elevating the breast tissue temperature by about 1 degree Celsius and an array of ultrasound probes surrounding the breast gather the acoustic wave generated due to mild tissue heating. The thermal map obtained over a broad frequency range of 1-3 GHz is used for spectroscopic thermoacoustic imaging and retrieving spatial map of the complex dielectric properties of the breast.There is a need for a patient-friendly and improved noninvasive system for radiative treatment of tumors. These and other advantages will be more readily understood by referring to the following detailed description disclosed hereinafter with reference to the accompanying drawing and which are generally applicable to other evaporators to fulfill particular application illustrated hereinafter.SUMMARY OF THE INVENTION The invention discloses systems, devices and methods for delivering localized microwave hyperthermia with ultrasound image guidance. According to one embodiment of the present subject matter, a phased array applicator device for delivering localized hyperthermia to a tissue using image guidance is disclosed. In various embodiments, the device includes a hyperthermia applicator tank having a wall and an open top, the tank having a central axis thereof, the wall embedded with a plurality of patch antennas arranged in at least two rings and three equiangularly placed windows placed between the patch antennas and covered with a material configured to allow ultrasound propagation, the tank is configured to hold a dielectric medium surrounding an organ and adapted to rotate about its axis and orient the plurality of patch antennas to selectively deliver microwave hyperthermia to a target tissuewithin the organ. In various embodiments, the plurality of patch antennas are positioned in the applicator tank surrounding the organ and each antenna having an associated water bolus, the antennas configured to provide power deposition by selective switching and to regulate target tissue temperature to a hyperthermia range. In various embodiments, the device includes three ultrasound transducers placed behind the windows, the transducers are adapted to generate ultrasound beams and gather images of the organ. In various embodiments, on rotation of the applicator tank, the antennas are configured to irradiate the target tissue while the plurality of ultrasound transducers are concurrently configured to move vertically up or down for real-time scanning of the organ and provide ultrasound imaging of the organ including the target tissue to generate 3D organ imaging and 3D tissue thermal data. In various embodiments, the antennas are switchable to provide microwave heating to the target tissue in response to control inputs based on the ultrasound imaging data and the 3D tissue thermal data. In various embodiments, the dielectric medium in the applicator tank is temperature-controlled deionized (DI) water. In various embodiments, the windows are made of polyvinyl chloride with a thickness of 1-2 mm. In various embodiments, the patch antennas in each ring number from three to six. In various embodiments, the patch antennascomprise three rings having four antennas each at a spacing of 90°, and wherein each ring of antennas is staggered at 45? with reference to the adjacent ring. In various embodiments, the patch antennas comprise three rings, the top and bottom rings having three antennas each at a spacing of 120° and the middle ring has six antennas, the antennas being offset by a predetermined angle with reference to the top and bottom rings. In various embodiments, the patch antennas comprise two rings, the top and bottom rings having six antennas each, the antennas in each ring placed one above the other without angular offset. In various embodiments, each patch antenna comprises a patch, a cavity with deionised water and a threaded hole on an outside surface of the cavity to attach an SMA connector.In various embodiments, the patch antennas include individual or shared water bolus.In various embodiments, each of the patch antennas is configured to operate at varying phase or power. In various embodiments, the patch antennas are configured to operate at 433 MHz or lower frequencies. In various embodiments, the ultrasound transducers are configured to operate at over 2-5 MHz and provide a depth of coverage of 15-20 cm in tissue.In various embodiments, the ultrasound transducerscomprise an array of linear or curvilinear convex transducers. According to another embodiment of the present subject matter, a system for treating breast tumours in a subject by optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping is disclosed. In various embodiments, the system includes a platform operable to support a user in prone position to receive microwave radiation from an applicator device, the platform having a breast plate with openings is configured to accommodate breasts of the subject in pendant orientation, the platform having a longitudinal platform axis, and a horizontal platform axis at 90? to the longitudinal along the breast plate. In various embodiments, the system includes the phased array applicator device, mounted on an applicator positioning unit, the device comprising a hyperthermia applicator tank integrated with a plurality of ultrasound transducers to generate ultrasound imaging data. In various embodiments, the applicator tank has a plurality of patch antennas adapted to hold a dielectric medium surrounding a breast to selectively deliver microwave hyperthermia to a target tissue therewithin. In various embodiments, the applicator positioning unit having first, second and third actuators, the first actuator configured to move the applicator device along the horizontal axis, the second actuator configured for vertical movement of the applicator device, and the third actuator configured for 45? angular rotation of the applicator device about an axis thereof, an RGB camera, an inertial measurement unit (IMU) sensor and a ring light to illuminate the applicator tank, and a control unit configured to receive control inputs from the camera and the IMU sensor and provide control signals to the actuators for applicator positioning. In various embodiments, the system includes a graphical user interface enabling visualization of the ultrasound imaging data, the thermal maps and the measured microwave radiation over the scanned area along with a visible range thereof.In various embodiments, the system includes a water conditioning unit configured to circulate water and regulate temperature of the dielectric medium. In various embodiments, the system includes a controller comprising a computer having a processor, memory and an integrated power source, communicably connected to the phased array applicator device, and the applicator positioning unit. In various embodiments, the controller includes an ultrasound imaging module integrated with the applicator device and configured to provide real-time imaging of the organ based on the ultrasound imaging data for thermal map generation. In various embodiments, the controller includes a thermal imaging module configured to generate real-time thermal maps of the target breast based on 3D beam formed radiofrequency (RF) data from proximally positioned ultrasonic transducers. In various embodiments, the controller includes a visible image processing module configured to extract visible image data and position the breast. In various embodiments, the controller includes a regulator configured to control the phase and power of microwave energy, regulate functions of the phased array applicator device, the applicator positioning unit, the graphical user interface, the ultrasound imaging module, the thermal imaging module, and the visible image processing module to determine the target location to deliver heating and to control the water conditioning unit to regulate the temperature of the dielectric medium. In various embodiments, the controller includes a feedback unit configured for fine tuning delivery of microwave energy to the target location based on analysis of ultrasound imaging data. In various embodiments, theapplicator positioning unit is configured forhorizontal and rotational movement of the applicator device and concurrent vertical movement of the ultrasound transducer to adjust depth position of the breast based on the ultrasound imaging data. In various embodiments, the applicator positioning unit is configured foroptically determining position, scanning area of the breast and to capture real time images of the breast using the camera. In various embodiments,the platform includes a frame to support the applicator positioning unit. In various embodiments,the platform includes resting panels to the user at contact points such as head, chin, hands, torso and feet. In various embodiments,the resting panels comprise variable cushioning densities to comfortably support the user. In various embodiments, the platform includes measurement and reference points to record the position of the user. In various embodiments, the breast plate includes a concealer configured to conceal one of the breasts from receiving microwave radiation from the applicator device during operation. In various embodiments,the water conditioning unit is configured to supply or to top up the dielectric medium and to regulate temperature thereof. In various embodiments, the power source includes a power amplifier module configured to excite the antennas in the phased array applicator device.In various embodiments,the system includes a laser unit to generate a laser beam for positional calibration. According to another embodiment of the present subject matter, a method for optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping is disclosed. In various embodiments, the method includes the steps of providing the phased array applicator device, the device comprising an applicator tank with a plurality of rings affixed with a plurality of patch antennas adapted to hold a dielectric medium surrounding a target organ to selectively deliver microwave hyperthermia to a target tissue therewithin, and a plurality of ultrasound transducers interspersed therebetween to generate ultrasound imaging data. In various embodiments, the next step includes providing an applicator positioning unit adapted to move the applicator device, the applicator positioning unit comprising first, second and third actuators, a camera, an IMU sensor and a ring light, the camera and IMU sensor providing control inputs to a control unit followed by placing a subject on a platform having openings configured to accommodate the target organ of the subject. In various embodiments, the method step of optimizing position of a target tissue within the target organ at the focal point of the applicator device includes positioning the phased array applicator device with respect to the subject followed by placing the target organ of the subject within the applicator tank. Then recording control signals for the first, second and third actuators required for positioning the target organ of the subject takes place followed by generating ultrasound beams by the plurality of ultrasound transducers and receiving and acquiring multi-view pre-operative ultrasound image data of the target organ in an ultrasound imaging module from the received ultrasound beams. This is followed by capturing a 3D model of the applicator using the camera and IMU sensor data to provide locations of the plurality of patch antennas. In the next step, constructing a pre-operative 3D ultrasound image of the target organ from the acquired multi-view pre-operative ultrasound image data by image compounding in the ultrasound imaging module takes place followed by performing segmentation of the pre-operative 3D ultrasound image of the target organ by the ultrasound imaging module to provide a 3D segmented model of the target organ. This is followed by identifying position of healthy and tumorous tissue volumes in the target organ by computing the 3D segmented model by a controller. In various embodiments, the method further includeproviding image guided localized hyperthermia to the target tissue with real-time temperature mapping using the phased array applicator device. This includes pre-operative positioning of the target tissue by the controller that include providing the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model to the controller followed by importing the image and model inputs to an EM simulation environment. The next step includesrotating the applicator to optimally position the tumorous tissue volume for treatment monitoring and delivering microwave hyperthermia followed by determining optimal phase and power to be delivered by each of the patch antennas based on the ultrasound image data. This step is followed by feeding a microwave field distribution in the 3D segmented model in a regulator andproviding the data of optimal positioning, optimal phase and power, and the microwave field distribution to determine pre-operative positioning of the target tissue. In various embodiments, the method further include providing image guided localized hyperthermia with real-time temperature mapping. This include retrieving recorded control inputs for the first, second and third actuators for the target organ followed by retrieving the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model for the target organ, retrieving the data of optimal positioning, the optimal phase and power, and the microwave field distribution to determine positioning of the target tissue to deliver and guide microwave excitation. In various embodiments, the next step includes capturing beamformed radiofrequency data from pre-operative 3D ultrasound images, the 3D applicator model and the 3D segmented model in a thermal imaging module followed by generating an ultrasound- thermal map from the acquired beamformed radiofrequency data. The next step include positioning the ultrasound transducers at the optimal positions based on the generated ultrasound thermal maps followed by guiding and monitoring the microwave radiation through an optimal combination of patch antennas based on the retrieved data. The next step include capturing multi-view post-operative ultrasound images to provide beamformed radiofrequency data followed by generating post-operative ultrasound- thermal map from the acquired beamformed radiofrequency data andproviding real-time feedback for post-operative optimal heating of the target tissue in a feedback unit. In various embodiments, the method includegathering B-mode images of the organ via the plurality of ultrasound transducers.In various embodiments, the method includerotating the applicator tank up to 45° clockwise or counter clockwise to obtain multi-view images of the organ.In various embodiments, the method includeacquiring multi-view pre-operative ultrasound image data comprises combining acquired B- mode images at different views with different orientations of the ultrasonic transducers with respect to coordinates of the target organ. In various embodiments, generating ultrasound- thermal maps from acquired beamformed radiofrequency data include the steps of acquiring beamformed radiofrequency of the target organ in the thermal imaging module followed by estimating a cumulative time shift along each A-line corresponding to the target organ of the acquired beamformed radiofrequency data with respect to a previous frame. The next step include smoothing the cumulative time shift estimate by curve fitting and low pass filtering on the cumulative time shift map followed by estimating gradient of cumulative time shift map along each A-line and filtering the gradient of cumulative time shift map using low pass filters. Next step include accumulating gradient of cumulative time shift maps followed by mapping to temperature change using calibration. In various embodiments,determining optimal phase and power to be delivered by each of the patch antennas comprises calculating power and phase of the microwave excitation to be given to individual antennas in the applicator device such that power deposition inside the tumor target is maximized and power deposition in healthy tissues is minimized. In various embodiments, the method comprises circulating the dielectric medium by a water conditioning unit for regulating temperature of the applicator tank during operation. In various embodiments, positioning the ultrasound transducers at the optimal positions based on the generated ultrasound thermal maps include the steps of obtaining target tissue segmentation data from the ultrasound imaging unit followed by positioning the plurality of ultrasonic transducers by selecting single or multi-plane alignment or positions of the ultrasonic transducers based on target tissue segmentation data and guiding the microwave radiation with a switching matrix for selecting optimal patch antennas based on defined target tissue. In various embodiments, providing real-time feedback for post-operative optimal heating of the target tissue include the steps of calculating location, intensity and extent of heating from the ultrasound image data followed by comparing with treatment predictions performed by the controller. This is followed by updating power and phase settings of the phased array applicator device to compensate for offset in location and reducing the heating at the tumour or overheating at healthy tissue volume. Next step include selecting the optimal settings among the potential settings and updating regulator settings followed by providing microwave radiation with updated regulator settings, monitoring temperature change in the post-operative ultrasound- thermal map andcontinuing optimized regulator settings during treatment. In various embodiments, the method comprises displaying the real-time scanned images of the organ in a graphical user interface (GUI). This and other aspects are disclosed herein.BRIEF DESCRIPTION OF THE DRAWINGS The invention has other advantages and features which will be more readily apparent from the following detailed description of the invention and the appended claims, when taken in conjunction with the accompanying drawings, in which: FIG. 1A:a schematic representation of a phased array applicator device. FIG. 1B: aperspective view of the phased array applicator device. FIG. 1C: a schematic representation of an antenna arrangement in threerings. FIG. 1D: a schematic representation of a hyperthermia applicator tank. FIG. 1E: a schematic representation of an applicator showing windows for ultrasound. FIG. 1F: a schematic representation of a patch antenna. FIG. 1G: a schematic representation ofside view of a patch antenna. FIG. 1H: showing staggered arrangement of antennas inembodiments of the phased array applicator. FIG. 1I: showing top view of axis of rotation of the hyperthermiaapplicator tank. FIG. 2: showing a system (200)for treating breast tumours in asubject by optimizing organposition within a phased arrayapplicator device and providingimage guided localizedhyperthermia with real-timetemperature mapping. FIG. 3A: showing a phased array applicator device mounted on the applicator positioning unit. FIG. 3B: showing front view of applicator with the positioning device. FIG. 3C: showing side view of applicator with the positioning device. FIG. 3D: showing perspective view of the applicator deviceand breast plate for treatment of right breast. FIG. 3E: showing perspective view of the applicator deviceand breast plate for treatment of left breast. FIG. 4A: showing frame supporting the applicator and positioning device. FIG. 4B: showing the treatment platform with the applicator device, water conditioning unit and power source. FIG. 4C: showing the platform withbreast plate and support cushioning. FIG. 4D: showing perspective view of the platform with breast plate and other components. FIG. 4E: showing side view of the platform with breast plate and other components. FIG. 4F: photograph showing the phased array applicator with 18 staggered arrangement of water loadedcavity backed 433 MHz antennas. FIG. 4G: photograph showing the platform with breast plate and other components. FIG. 4H: photograph showing the system with positioning platform for the phased array applicator andintegrated power delivery source and water conditioning unit. FIG. 5A: flow diagram showing method for optimizing organ position within a phased array applicator deviceand providing image guided localized hyperthermia with real-time temperature mapping. FIG. 5B: a flow diagram showing steps for optimizing position (304) of targettissue at focal point of applicator device. FIG. 5C: a flow diagram showing steps for providing (313) pre-operative positioningof target tissue. FIG. 5D: a flow diagram showing steps for providing image (322) guided localized. FIG. 5E: a flow diagram showing steps for generating ultrasound- thermal maps (327) from acquired beamformed radiofrequency data. FIG. 5F: a flow diagram showing steps for Positioning (328) theultrasound transducers at the optimal positions. FIG. 5G: a flow diagram showing steps for providing real-time feedback (332) for postoperativeoptimal heating of the target tissue. FIG. 6A: showing a 3D model of patient derived breast. FIG. 6B: showing electronic beam steering of power deposition by phased array applicator at varying (upper outer, center and lower inner quadrants) locations inside the breast using 18 antennas. FIG. 6C: showing 8 out of 18 antenna excitation- based on array thinning and global optimization. FIG. 7A: showing fabricated breast parenchyma with thermometry catheters. FIG. 7B: showing fiber optical probe placement in phantom. FIG. 7C: showing heating experiment results: invasive probe measurements for two excitation settings for optimal subset of 8 out of 18 antennas determined by simulations. FIG. 7D: showing IR thermal image in mid plane at the end of excitation setting 2. FIG. 8A: showing breast phantom with inserts. FIG. 8B: showing linear transducer images of phantom. FIG. 8C: showing curvilinear transducer images of phantom. FIG. 9A-9C showing multiview images of breast phantom using curvilinear ultrasound transducer (1st, 2nd and 3rd view). FIG. 10A-10B: showing ultrasound compound imaging of single slice of scattered image. FIG. 10A: showing input image slice for B-mode image formation. FIG. 10B: showing reconstructed image using 24 views using curvilinear ultrasound transducer. FIG. 11A-11E: showing simulation results of automated ultrasound imaging of the breast in prone position. FIG. 11A: showing transducer design. FIG. 11B: showing sectional view of breast phantom. FIG. 11C: showing scatter distribution.FIG. D: showing beam formed data (B-mode image). FIG. E: showing 3D segmented image stack of simulated breast phantom with lesions. FIG. 12A: showing experimental setup for Phantom heating experiment- I. FIG. 12B: showing position of fiber optic thermometer probes inside phantom 1. FIG. 12C: showing graphical representation of measured reflection coefficient of antennas at 434 MHz for Phantom heating experiment- I. FIG. 12D: showing SAR distribution (simulation) inside phantom mid planefor Phantom heating experiment- I. FIG. 12E: showing graphical representation of temperature v / s time plot (FOT data)for Phantom heating experiment- I. FIG. 13A: showing experimental setup for Phantom heating experiment- II. FIG. 13B: showing position of fiber optic thermometer probes inside phantom 2. FIG. 13C: showing SAR distribution (simulation) inside phantom mid planefor Phantom heating experiment- II. FIG. 13D: showing graphical representation of temperature v / s time plot (FOT data)for Phantom heating experiment- II. FIG. 14A: showing experimental setup for Phantom heating experiment- III FIG. 14B: showing position of fiber optic thermometer probes inside phantom 3 FIG. 14C: showing SAR distribution (simulation) inside phantom mid planefor Phantom heating experiment- III. FIG. 15A: showing ultrasound B mode image and FOT probe locations gathered before heating (0° view). FIG. 15B: showing ultrasound image acquisition: 5 cm height (+ / 2.5 cm from heating plane, 5° rotation and total 30 views per plane). FIG. 15C: showing reconstructed compound image for 5° rotation at given z location / height during Compound ultrasound 2D slice formation (5° rotation) process. FIG. 15D: images showing compound ultrasound 2D slice formation (5° rotation). FIG. 15E: 2D image reconstruction- 1st slice (Post processing and segmentation on compound ultrasound image data- input to treatment planning). FIG. 15F: 3D reconstruction- Post boundary identification FIG. 15G: showing ultrasound A-line analysis- threshold level for gating thermal estimate in A- line data. FIG. 15H: showing graphical representation of temperature v / s time plot (FOT data)- Ground truth data. Temperature rise recorded by invasive fiber optic temperature probe. FIG. 16A: showing analysis of different material for the container section of ultrasound. FIG. 16B: showing images with different material for the container section of ultrasound. FIG. 17: showing scatter plot for Field II simulation. FIG. 18: showing compound Image reconstruction with Number view with Probe Rotation. FIG. 19: showing compound image reconstruction with Number view with Container Rotation. FIG. 20A-D: showing 3D model reconstruction from 24 views. FIG. 21A-D: showing 3D model reconstruction from container rotation of +15, 0 and -15 degrees. FIG. 22A-D: showing 3D Model reconstruction from container rotation +30, 0 and -30 degree rotations. FIG. 23A: showing probe position in container. FIG. 23B:showing ultrasound imaging setup with phased array applicator. FIG. 23C: showing treatment / imaging framework. FIG. 23D: showing treatment / imaging framework for container rotation. FIG. 23E: showing camera co-ordinates and marker co-ordinates position. FIG. 23F: showing photographic image of the position of camera, IMU sensor and ring light in the prototype setup. FIG. 23G: graphical representation showing an average of 10 measurements obtained from IUM sensor gyroscope during container rotation of +45 degree. FIG. 23H: graphical representation showing an average of 10 measurements obtained from IUM sensor gyroscope during container rotation of -45 degree. FIG. 24A-B: experimental setup of thermal imaging of the breast FIG. 24C: showing the temperature rise recorded by the invasive fiber optic probe. FIG. 24D: showing US B-mode Image at the beginning of heating – Single view B mode image at heating plane. FIG. 24E: showing US B-mode Image at the end of heating - Single view B mode image at heating. FIG. 24F: showing comparison of central A line inside the phantom pre and post heating displayed on the same timescale FIG. 24G: magnified view of the A-line showing the time shift between the signals. FIG. 24H: showing gradient of cumulative time shift estimates, FIG. 24I: showing scaled to temperature using calibration constant and regions of low SNR masked. FIG. 24J: showing cumulative time shift estimate, (a) Raw estimate, FIG. 24K: showing polynomial fit estimate. FIG. 24L: showing thermal map estimated by ultrasound without masking. FIG. 24M: showing thermal map estimated by ultrasound with masking.Referring to the figures, like numbers indicate like parts throughout the various views.DETAILED DESCRIPTION OF THE EMBODIMENTS While the invention has been disclosed with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt to a particular situation or material to the teachings of the invention without departing from its scope. Throughout the specification and claims, the following terms take the meanings explicitly associated herein unless the context clearly dictates otherwise. The meaning of "a", "an", and "the" include plural references. The meaning of "in" includes "in" and "on." Referring to the drawings, like numbers indicate like parts throughout the views. Additionally, a reference to the singular includes a reference to the plural unless otherwise stated or inconsistent with the disclosure herein. In various embodiments, the invention discloses systems, devices and methods for delivering localized microwave hyperthermia with ultrasound image guidance. In one embodiment, the invention discloses a phased array applicator device and systemfor organ positioning and delivering targeted hyperthermia treatment to the organ usingultrasound providing image guided real-time temperature mapping. The invention further discloses a methodfor optimizing organ position and providing image guided localized hyperthermia with real-time temperature mapping using ultrasound image data. The device, system and method may efficiently facilitate targeted heating of locally advanced breast cancer (LABC), as further illustrated with reference to the drawings. In various embodiments, a phased array applicator device 100 for delivering localized hyperthermia to a tissue using image guidance is now disclosed with reference to the drawings. As shown in FIG. 1A and FIG. 1B, the device comprises a hyperthermia applicator tank 101 having a wall and an open top, the tank has a central axis 102. The bottom of the tank may be transparent to facilitate illumination from below. The wall is embedded with a plurality of patch antennas 103 arranged in two to three rings 104.Three equiangularly placed windows105are located between the patch antennas and covered with a material configured to allow ultrasound propagation.The tank 101is configured to hold a dielectric medium 106 surrounding an organ 107. The tank is adapted to rotate about its axis and orient the plurality of patch antennas 103 to selectively deliver microwave hyperthermia to a target tissue 108 within the organ 107. The plurality of patch antennas 103are positioned in the applicator tank 101 surrounding the organ 107.In various embodiment, the antenna arrangement is shown in FIG. 1C, FIG. 1D and FIG. 1H. Each antenna has an associated water bolus, and the antennas are configured to provide power deposition by selective switching and to regulate the target tissue temperature to a hyperthermia range.Three ultrasound transducers 109are placed behind the windows 105, and the transducers109areadapted to generate ultrasound beams and gather images of the organ 107. On rotation of the applicator tank 101, the antennas 103 are configured to irradiate the target tissue 108.The plurality of ultrasound transducers 109 are concurrently configured to move vertically up or down for real-time scanning of the organ 107 and provide ultrasound imaging of the organ 107 including the target tissue 108 to generate 3D organ imaging and 3D tissue thermal data.The antennas are switchable to provide microwave heating to the target tissue 108 in response to control inputs based on the ultrasound imaging data and the 3D tissue thermal data. In various embodiments, the dielectric medium 106in the applicator tank101 is temperature-controlled deionized (DI) water. In various embodiments, the windows 105 are made of polyvinyl chloride with a thickness of 1-2 mm. In various embodiments, the patch antennas 103 in each ring may number from three to six.In various embodiment, the ring arrangement is shown in FIG. 1C.In some embodiments, the patch antennas103 comprise three rings having four antennas each at a spacing of 90°, wherein each ring of antennas is staggered at 45? with reference to the adjacent ring. In some embodiments, the patch antennas103 comprise three rings, the top and bottom rings having three antennas each at a spacing of 120° and the middle ring has six antennas, the antennas being offset by a predetermined angle with reference to the top and bottom rings.In some embodiments, the patch antennas 103comprisetwo rings, the top and bottom rings having six antennas each, the antennas in each ring placed one above the other without angular offset. In various embodiments, each patch antenna 103 comprises a patch 110, a cavity 111 with deionised water to act as bolus and a threaded hole 112 on an outside surface of the cavity to attach an SMA connector. In various embodiments, the antenna parts are shown in FIG. 1F and FIG. 1G. In some embodiments, the patch antennas 103 may include individual or shared water bolus.In various embodiments, each of thepatch antennas 103is configured to operate at varying phase or power.In various embodiments, each of thepatch antennas 103is configured to operate at 433 MHz or lower frequencies. In various embodiments, the ultrasound transducers 109are configured to operate at over 2-5 MHz and provide a depth of coverage of 15-20 cm in tissue. In various embodiments, the ultrasound transducers 109may comprise an array of linear or curvilinear convex transducers. In various embodiments, the invention discloses a system 200 for treating breast tumours in a subject by optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mappingas shown in FIG. 2.The system comprises a platform 201, as shown in FIG. 4A-E, operable to support a user in prone position to receive microwave radiation from an applicator device.The platform has a breast plate 202 with openings configured to accommodate breasts of the subject in pendant orientation.The platform has a longitudinal platform axis, and a horizontal platform axis at 90? to the longitudinal along the breast plate202. The phased array applicator device 210is mounted on an applicator positioning unit 220as shown inFIG. 3A.The device 210 comprises a hyperthermia applicator tank 211 integrated with a plurality of ultrasound transducers 212 to generate ultrasound imaging data.The applicator tank has a plurality of patch antennas 213 adapted to hold a dielectric medium 214surroundinga breast215 to selectively deliver microwave hyperthermia to a target tissue216 therewithin. The applicator positioning unit 220,has first 221a, second 221b and third 221c actuators for positioning the applicatoras shown inFIG. 3A. The first actuator 221a is configured to move the applicator device 210 along the horizontal axis, and the second actuator 221bconfigured for vertical movement of the applicator device as shown in as shown inFIG. 3B-FIG. 3E. The third actuator 221c is configured for 45? angular rotation of the applicator device 210 about an axis thereof as shown in FIG. 1I.The applicator positioning unit 220 further includes an RGB camera 222, an inertial measurement unit (IMU) sensor 223 and a ring light 224 to illuminate the applicator tank 211. The control unit 225 is configured to receive control inputs from the camera 222 and the IMU sensor 223, and provide control signals to the actuators 221a, 221b, 221c for applicator positioning; The system 200 further includes a graphical user interface 230 enabling visualization of the ultrasound imaging data, the thermal maps and the measured microwave radiation over the scanned area along with a visible range thereof. The system includes a water conditioning unit 240 to circulate water and regulate temperature of the dielectric medium 214. The system 200includes a controller 250with a computer having a processor, memory and an integrated power source 251. The controller iscommunicably connected to the phased array applicator device 210, and the applicator positioning unit 220.The controller 250 comprises an ultrasound imaging module 252 integrated with the applicator device 210 and is configured to provide real-time imaging of the organ based on the ultrasound imaging data.A thermal imaging module 253is configured to generate real-time thermal maps of the target breast 215 based on 3D beam formed radiofrequency (RF) data from proximally positioned ultrasonic transducers 212. A visible image processing module 254 is included in the system to extract visible image data and to help position the applicator with reference to the breast 215. The system 200 further includes a regulator 255 configured to control the phase and power of microwave energy, by regulatingfunctions of the phased array applicator device 210. The regulator is further configured to controlthe applicator positioning unit220, the graphical user interface 230, the ultrasound imaging module 252, and the thermal imaging module 253.The regulator controls thevisible image processing module 254 to determine the targetlocation to deliver targeted heating and to control the water conditioning unit 240 to regulate the temperature of the dielectric medium 214. The system further includes a feedback unit 256 configured for fine tuning delivery of microwave energy to the target location based on analysis of the ultrasound imaging data. In various embodiments of the system, the applicator positioning unit 220 is configured forhorizontal and rotational movement of applicator device 210 and concurrent vertical movement of the ultrasound transducer to adjust depth position of the breast 215 based on the ultrasound imaging data.The applicator positioning unit is also configured to optically determine position, scanning area of the breast 215 and to capture real time images of the breast using the camera 222. In various embodiments of the system, the platform201 includes a frame 2020 to support the applicator positioning unit 220. In various embodiments, the platform 201 includes resting panels to the user at contact points such as head 203, chin 204, hands 205, torso 206 and feet 207. In various embodiments, the resting panels may comprise variable cushioning densitiesto comfortably support the user. In various embodiments of the system, the platform 201 includes measurement and reference points 208 to record the position of the user. In various embodiments of the system, the water conditioning unit 240 is configured to supply or to top up the dielectric medium 214 and to regulate temperature thereof. In various embodiments of the system, the power source 251 includes a power amplifier module configured to excite the antennas in the phased array applicator device210.In various embodiments of the system, the system includes a laser unit 260 to generate a laser beam for positional calibration. In various embodiments of the system, the breast plate 202 includes a concealer 209 configured to conceal one of the breasts from receiving microwave radiation from the applicator device during operation. In another embodiment, amethod 300for optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping is disclosed in FIG. 5A.The method involves the step of providing 301 the phased array applicator device comprising an applicator tank, wherein the device includes a plurality of rings affixed with a plurality of patch antennas located in the tank is configured to hold a dielectric medium. The target organ is surrounded by dielectric medium to selectively deliver microwave hyperthermia to a target tissue. The device further comprises plurality of ultrasound transducers interspersed therebetween to generate ultrasound imaging data. In various embodiments, the method 300furtherprovides302 an applicator positioning unit configured to move the applicator device.The applicator positioning unit further comprises the first, second and third actuators, camera, IMU sensor and ring light. The camera and IMU sensor are configured to provide inputs to a control unit. The method then involves placing303 the subject on the platform having openings configured to accommodate the target organ of the subject. In various embodiments, the method 300 involvesoptimizing the position 304 of a target tissue within the target organ at the focal point of the applicator device as shown inFIG. 5B. The step of optimization of the position further includes positioning 305 the phased array applicator device with respect to the subject. Placing 306 the target organ of the subject within the applicator tank. In various embodiments, the method records307 the control signals for the first, second and third actuators for positioning the target organ of the subject. In various embodiments, the ultrasound transducers are configured to generate 308 the ultrasound beams. In various embodiments, the method includes receiving and acquiring 309 multi-view pre-operative ultrasound image data of the target organ in an ultrasound imaging module from the received ultrasound beams. In various embodiments, the camera and IMU sensor data are used to capture 310 the 3D model of the applicator to provide locations of the plurality of patch antennas. In various embodiments, the multi-view pre-operative ultrasound image data by image compounding in the ultrasound imaging module in involved in constructing 311 a pre-operative 3D ultrasound image of the target organ. Further, the method performs 312 segmentation of the pre-operative 3D ultrasound image of the target organ by the ultrasound imaging module to provide a 3D segmented model of the target organ. In various embodiments, the controller is configured to identify 313 the position of healthy and tumorous tissue volumes in the target organ by computing the 3D segmented modelas shown inFIG. 5C. In various embodiments, the method 300 providesin step 314 image guided localized hyperthermia to the target tissue.In various embodiments, the phased array applicator device is configured to provide hyperthermia to the target tissue with real-time temperature mapping. The method comprises pre-operative positioning 315 of the target tissue by the controller. In various embodiments, the method further provides316 the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model to the controller. In various embodiments, the method includes the step of importing317 the image and model inputs to an EM simulation environment. The treatment monitoring and delivering microwave hyperthermia is achieved by rotating 318 the applicator to optimally position the tumorous tissue volume. In various embodiments, the method 300 determines 319 optimal phase and power to be delivered by each of the patch antennas based on the ultrasound image data. Next, feeding a microwave field distribution in the 3D segmented model in a regulator takes place in step 320. Further, the pre-operative positioning of the target tissue is determined by providing 321 the data of optimal positioning, optimal phase and power, and the microwave field distribution. In various embodiments, the method provides 322 image guided localized hyperthermia with real-time temperature mapping, as shown inFIG. 5D. In various embodiments, the method retrieves 323 the recorded control inputs for the first, second and third actuators of the target organ. Also, the method retrieves 324 the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model of the target organ. Determine positioning of the target tissue to deliver and guide microwave excitation by retrieving 325 the data of optimal positioning, the optimal phase and power, and the microwave field distribution. In various embodiments, the method includes capturing 326 of the beam formed radiofrequency data from pre-operative 3D ultrasound images, the 3D applicator model and the 3D segmented model in a thermal imaging module.In various embodiments,the method includes generatingthe ultrasound- thermal map from the acquired beamformed radiofrequency data in step 327. The method further includes positioningof the ultrasound transducers at the optimal positions based on the generated ultrasound thermal maps in step 328 as shown in FIG. 5F. In various embodiments, guiding and monitoring the microwave radiationthrough an optimal combination of patch antennas is carried based on the retrieved data takes place in step 329. In order to provide beam formed radiofrequency data capture 330 the multi-view post-operative ultrasound images. The methods effectively generate 331 the post-operative ultrasound- thermal map from the acquired beamformed radiofrequency data. Providing real-time feedback for post-operative optimal heating of the target tissue in a feedback unit takes place in step 332 as shown in FIG. 5G. In various embodiments, the method 300 gathers B-mode images of the organ via the plurality of ultrasound transducers. In various embodiments, the method 300 includes rotating the applicator tank up to 45° clockwise or counterclockwise to obtain multi-view images of the organ. In various embodiments, the method 300 includes acquiring multi-view pre-operative ultrasound image data which includes combining acquired B- mode images at different views with different orientations of the ultrasonic transducers with respect to coordinates of the target organ. In various embodiments, ultrasound- thermal maps generation in step 327 from acquired beamformed radiofrequency data include the steps of acquiring 3271 beamformed radiofrequency data along the target organ in the thermal imaging module, as shown inFIG. 5E. Next, estimating 3272 a cumulative time shift along each A-line corresponding to the target organ of the acquired beamformed radiofrequency data with respect to a previous frame. This is followed by smoothing 3273 the cumulative time shift estimate by curve fitting and low pass filtering on the cumulative time shift map. The next step includes estimating the gradient of cumulative time shift map along each A-line in step 3274. Further, the low pass filters are configured to filter 3275 the gradient of cumulative time shift map followed by Accumulating 3276 gradient of cumulative time shift maps. In the final step, mapping 3277 is done for temperature change using calibration. In various embodiments, calculating power and phase of the microwave excitation to be given to individual antennas in the applicator device is carried out by determining 319 optimal phase and power to be delivered by each of the patch antennas. This calculation witness that power deposition inside the tumor target is maximized and power deposition in healthy tissues is minimized. In various embodiments, the method 300 comprises circulating the dielectric medium for regulating temperature of the applicator tank during operation by a water conditioning unit. Based on the generated ultrasound thermal maps, the positioning 328 of the ultrasound transducers at the optimal positions is configured. The ultrasound imaging unit is configured to obtain 3281 the target tissue segmentation data followed by positioning 3282 the plurality of ultrasonic transducers by selecting single or multi-plane alignment or positions of the ultrasonic transducers based on target tissue segmentation data. Next step includes guiding 3283 the microwave radiation with a switching matrix for selecting optimal patch antennas based on defined target tissue.In various embodiments, to provide real-time feedback 332 for post-operative optimal heating of the target tissue, the method calculates 3321 the location, intensity and extent of heating from the ultrasound image data. Next step 3322 includes comparing with treatment predictions performed by the controller followed by updating the power and phase settings of the phased array applicator device in step 3323 to compensate for offset in location. In the next step 3324, reducing the heating at the tumour or overheating at healthy tissue volume followed by selecting the optimal settings among the potential settings and updating regulator settings. The next step 3325 includes providing the microwave radiation with updated regulator settings followed by monitoring temperature change in the post-operative ultrasound- thermal map in step 3326 and continuing the optimized regulator settings during treatment in step 3327. In various embodiments, the method comprises displaying the real-time scanned images of the organ in a graphical user interface (GUI). The apparatus / system,of the present invention, for organ positioning and delivering targeted hyperthermia treatment to the organ with ultrasound image guidance for treatment planning, and 3D noninvasive tissue thermometry. The apparatus / systemprovides ultrasound image guidance for microwave delivery planning, and 3D non-invasive tissue thermometry. The positioning arrangement of the system for lateral and rotational movements of the phased array applicator positions the applicator to treat the organ of interest. The platform disclosed is an ergonomically designed platform with positioning and functional modules which significantly contribute inuser’s comfort, helping the user to remain relaxed and at ease throughout the entirety of the operation. Although the detailed description contains many specifics, these should not be construed as limiting the scope of the invention but merely as illustrating different examples and aspects of the invention. Various other modifications, changes and variations which will be apparent to those skilled in the art may be made in the arrangement, operation and details of the system and method of the present invention disclosed herein without departing from the scope of the invention as described here and as set forth in the claims attached herewith.EXAMPLES EXAMPLE 1: FABRICATION OF ASYSTEM FOR OPTIMIZING ORGAN POSITION WITHIN A PHASED ARRAY APPLICATOR DEVICE Microwave hyperthermia system for targeted heating of breast tumor in intact breast according to the claimed embodiments was fabricated, as illustrated in FIG. 4G. FIG. 4F shows a phased array applicator with 18 staggered arrangement of water loaded cavity backed 433 MHz patch antennas. FIG. 4H shows a system (200) with an arrangement for optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping with an applicator positioning unit, a motorized platform, a water conditioning unit and a controller with integrated power delivery source. The components of the system are further illustrated with reference to the drawings. The phased array applicator device components: 1) Applicator tank: A phased array applicator for hyperthermia treatment consisted of patch antennas distributed on a cylindrical tank. Different configurations of phased array applicator having varying antenna arrangement and numbers are presented. The phased array applicator is shown in FIG. 1C, FIG. 1D, FIG. 1E, FIG. 1H, FIG. 1I. Referring to FIG. 1C, illustrates an embodiment of phased array tank and applicator, which has three rings having 6 antennas in each ring and the spacing between antennas in each ring is 60°. Referring to FIG. 1E, illustrates the phased array tank and applicator, with three rings having 4 antennas wherein each ring and the spacing between antennas in each ring is 90°. Referring to FIG. 1H, illustrates an embodiment of phased array tank and applicator, which has three rings top and bottom rings have 3 antennas in each ring and the spacing between antennas is 120°, whereas the middle ring has 6 antennas and the spacing between them is 60°. An assembly of sub arrays fitted on to the cylindrical tank with individual or shared water bolus may be used to ensure controlled water temperature for cooling the antenna during treatment, thereby minimizing power loss and maximizing power coupling FIG. 1H and FIG. 4H. 2) The microwave antenna: The antenna used in the claimed system is disclosed with reference to FIG. 1F and FIG. 1G. The microwave antenna may be any dielectric loaded miniaturized resonant patch antennas with grounded dielectric substrate. The microwave antenna as shown in FIG. 1F and FIG. 1G may fit into a compact size with a mechanical assembly that is easy to attach it to the phased array tank and make it leak proof. Referring to FIG. 1F illustrates one such design of cavity backed patch antenna, having a cavity and a patch, which is the radiating element of the antenna, attached to the cavity with deionized (DI) water as the antenna substrate and superstrate. Referring to FIG. 1G, which illustrates the cut-section view of the antenna mid plane. A threaded hole is present on the outer surface of the antenna cavity to attach the customized SMA connector that too has threads. The internal arrangement of antennas within the applicator tank is meticulously designed to ensure stable connections. This design specifically addresses the potential issue of loose contact between the antenna and the RF power cable, which could arise during the movement of the applicator. Such an arrangement guarantees consistent and reliable performance of the system throughout its operation. EXAMPLE 2: PROVIDING IMAGE GUIDED LOCALIZED HYPERTHERMIA WITH REAL-TIME TEMPERATURE MAPPING 3) An ultrasound transducer: As illustrated in FIG. 1A, FIG. 1B, FIG. 3, the applicator tank was uniquely equipped with ultrasound probes (US transducers), which were designed to move vertically up and down for comprehensive scanning. In addition to this, the entire tank is capable of rotational movement, allowing both the antennas and the ultrasound probes to be precisely oriented towards the specific treatment area on the organ (breast). The system employed three transducers with fixed view / windows on the imaging container / platform with a mechanically rotating container having synchronized rotation of US transducer and provision for translation of US transducers.The integrated ultrasound feature was utilized for real-time monitoring, providing immediate feedback on the impact of microwave therapy on both the breast tissue and the tumor. Three curvilinear ultrasound transducers positioned 120 degrees apart around the applicator, each capturing ultrasound RF beamformed data from different scan angle in coronal plane positioned at same or different depth, enabling comprehensive thermal monitoring of one or many cross-sectional planes of the pendant organ were used. The results show that curvilinear transducer has deeper penetration and larger field of view than linear transducer. Thus, it was possible to get image information with limited views using curvilinear probe to generate treatment planning quality 3D model of the breast in prone position for microwave power deposition at tumor target. Choice of material for US transducer window: The surface of the imaging cum hyperthermia treatment container was conformal to the surface of the ultrasound probe. A study was carried out using the materials listed below for the interface design (Table 1). The container with open slot for material placement is shown in FIG. 16A and FIG. 16B shows the RF scattered A- mode US transducer data corresponding to the centre element in the US transducer (convex probe). Based on the results in FIG. 15A it was concluded that silicone had lower loss than PVC of 2 mm thickness. PVC of 1 mm thickness shown lesser signal attenuation than 2 mm thick PVC. PVC of 1 mm was observed to be best suited for our end application. The log compressed image data (B mode) of the US transducer with a phantom inside water tank is shown in FIG. 16B for the different imaging window materials. It was observed that 1 mm PVC provided good SNR and coverage. Table 1: List of Interface materials for US imaging windowS.No Material Average thickness in mm1 Polyvinyl chloride (PVC) 12 Polyvinyl chloride (PVC) 23 Silicone 1.5 4) Hyperthermia treatment patient bed: A motorized platform which is an ergonomically designed patient bed contains the phased array applicator, water circulation system, power amplifier unit was used to excite the antennas in the phased array, laser-based patient positioning unit, actuator system and image guidance for treatment planning, monitoring and control is shown in FIG. 4. Referring to FIG. 4D, which illustrates the head rest, arm rest, breast plate and foams of varying thickness. A comfort study on the presented patient bed was done which had 50 volunteers and their inputs were considered while fixing the position of head and arm rest and also the thickness of the foam. Referring to FIG. 4B, which illustrates the phased array applicator for HT of breast cancer, water circulation system and the power amplifier system integrated to the patient bed. Referring to FIG. 4A, which illustrates the frame of the patient bed, applicator for HT of breast cancer and the actuator system used for the lateral movement of the applicator on the patient bed. The motorized platform as shown in FIG.4C in magnified view, is meticulously designed to include a designated space for accommodating the untreated breast, ensuring its comfort and stability. Additionally, the device features a strategically positioned support over the sternum area. This ergonomic consideration aids in maintaining patient comfort throughout the duration of the hour-long treatment procedure. The motorized platform includes a novel feature where measurements and reference points are integrated onto the bed, specifically designed to record the positions of the patient's shoulders and ears, as shown in FIG. 4D and FIG. 4E. This unique aspect allows for precise documentation of the patient’s positioning, facilitating consistent and accurate repositioning in subsequent treatment sessions. The motorized platform / bed features a design with variable cushioning densities as illustrated in FIG. 4D, tailored to provide differential support across various contact points when a patient is on the bed. Specifically, the sternum support and adjacent chest regions are outfitted with a gel mat cushion, enhancing ergonomic comfort and easing patient experience during prolonged treatment sessions. The motorized platform may include hand rest and handle bar: The design of the bed incorporates two hand and arm rest panels positioned on either side adjacent to the chest region, as shown in FIG. 4D. These panels are specifically intended to offer comfortable support for the arms during treatment. Additionally, the panels are foldable, enhancing space efficiency when not in use. To further aid in user comfort and positioning, two handlebars are also integrated. These handlebars assist patients in adjusting their body or chest position, particularly when lying in a prone position, thereby facilitating correct breast positioning for treatment and improving overall comfort. The motorized platform may include joystick / interface: The motorized platform features a versatile joystick FIG. 4E and control panel / interface 2017, which are intuitively designed for the efficient operation of the system. This control mechanism enables precise manipulation of the breast chamber and ultrasound probes, as well as the activation of the laser grid. This user-friendly interface ensures seamless integration of the motorized platform's functionalities, allowing for smooth and accurate control of the treatment process. Incorporated into the design of motorized platform is a paper dispensing roll as shown in FIG. 4E, conveniently attached at the foot of the bed. This feature allows for the dispensing of paper over the cushioned surface of the bed, ensuring a sterile environment is maintained for each patient. The use of disposable paper coverings, easily accessible from the roll, provides an efficient and hygienic solution for maintaining cleanliness and reducing the risk of cross-contamination between patient sessions. The motorized platform is designed with a specialized headrest featuring a cavity, tailored to comfortably cradle and correctly position the user's head, as illustrated in FIG. 4D. Beneath this cavity, a digital display is strategically placed on a platform integrated with / under the headrest. This arrangement allows user to view the display through the cavity, providing a means of engagement or information during the treatment process. This feature significantly contributes to the user's comfort, helping them remain relaxed and at ease throughout the entirety of the treatment session. 5) The applicator positioning unit:The system is equipped with a strategically positioned camera outside the applicator tank, designed to facilitate the visualization of breast positioning. Complementing this, a laser grid is projected onto the organ (breast), significantly enhancing the precision in targeting and positioning for the treatment. Furthermore, the organ chamber is engineered to move linearly, accommodating either the left or right breast as required. For the untreated breast, a specially designed space, as illustrated in (FIG. 3A), is provided. This space was equipped with a removable and reversible panel, which can be flipped and adjusted to comfortably cover either the right or left untreated breast. This combination of visual aids and adaptable structural features represents a novel approach to ensuring accuracy, comfort, and efficacy in hyperthermia therapy application. EXAMPLE 3: IMAGE GUIDANCE FOR TREATMENT PLANNING AND NONINVASIVE TISSUE THERMOMETRY Image guidance for treatment planning and noninvasive tissue thermometry with ultrasound transducers interspaced between the microwave sub arrays for imaging of the organ to be treated (FIG. 1A). Vertical movement of the transducer, angular movement of the chamber containing the phased array antennas and water bolus combined with electronic beam steering of the transducer is used to gather beam formed RF data for 3D image reconstruction of the morphology information of the organ and delineate the lesion location and volume for microwave treatment planning. A wide-angle transducer operating over 2-5 MHz with a minimum of 2 to 4 transducers are proposed. The chamber with rotation of 45 degree combined with wide angle B-mode imaging is exploited for compound imaging and 3D automated patient specific image generation. During microwave phased array tissue heating, B mode images of the treated organ is analyzed to extract tissue temperature from speed of sound information in the beamformed RF data sequence. The image sequence from the proximal ultrasound transducers are analyzed for 3D noninvasive tissue thermal mapping. Thermal map generated from real time B mode images are used to provide real time feedback for targeted heating or steering of the microwave energy. EXAMPLE 4: SIMULATION OF POWER DEPOSITION BY PHASED ARRAY APPLICATOR FIG. 6 provide simulation results of switching matrix with electronic beam steering using optimal subset of antennas.Performance and power focusing capability of the phased array antenna system was simulated by 3D numerical modelling using ANSYS. The 3D model of a patient derived breast is shown in FIG. 6A. Electronic beam steering of power deposition by phased array applicator at varying (upper outer, center and lower inner quadrants) locations inside the breast using 18 antennas is shown in FIG. 6B. Using the simulation studies, it was found that using optimum location and phase parameters for 8 of the antennas, it is possible to achieve focused heating at a given location. The difference in volume of tissue heated on excitation of all 18 antennas FIG. 6B and on excitation of 8 out of the 18 antennas is shown in FIG. 6C. EXAMPLE 5: EXPERIMENTAL VERIFICATION OF ARRAY APPLICATOR PERFORMANCE USING TISSUE PHANTOMS 3D breast phantom was constructed and a silicone skin was printed to the required profile of the phantom. FIG. 7A shows positioning of temperature probes within the tissue phantom and FIG. 7B shows the instrumented breast parenchyma. Heating experiments were conducted by exciting 8 out of the 18 antennas with power and phase angle as shown in Table 2. FIG. 7C shows embedded probe measurements for two excitation settings using the antenna set shown in Table 2. The first setting corresponded to equiphase and equipower of all the antennas, while the second setting included varying phase and equipower as per Table 2. IR thermal image in mid-plane of the phantom at the end of excitation in setting 2 is shown in FIG. 7D.Table 2: Antenna Power and Phase Angle Settings for Optimized ConditionAntenna no. Mag. (W) Phase (°)1 15 02 15 1354 15 666 15 1357 14 25415 15 4616 14 7017 15 84 Tissue ultrasound imaging: Imaging was done by linear and curvilinear ultrasound transducers and the results are shown in FIG. 8A, FIG. 8B and FIG. 8C. The results showed that curvilinear transducer has deeper penetration and larger field of view than linear transducer. Thus, it is possible to get image information with limited views using curvilinear probe to generate treatment planning quality 3D model of the breast in prone position for microwave power deposition at tumor target. FIG. 9A, FIG. 9B and FIG. 9C show multiview images of breast phantom using curvilinear ultrasound transducer. Workflow was developed for 3D automated breast imaging with limited field of view dataset ad curvilinear ultrasound transducer. Workflow was developed for 3D automated breast imaging with limited field of view dataset ad curvilinear ultrasound transducer, as shown in FIG. 5A. Ultrasound compound imaging of single slice of scatterer image is shown in FIG. 10A and B. FIG. 10A shows input image slice for B-mode image formation, while FIG. 10B shows reconstructed image using 24 views using curvilinear ultrasound transducer. Simulation results of automated ultrasound imaging of the breast in prone position are shown in FIG. 11A to FIG. 11E. Materials and Measurements: Properties of the fibro-glandular tissue phantoms and tumor phantom and deionized water used in the study are shown in Table 3.Table 3: Materials used for Tissue Phantoms and their PropertiesMaterials Relative permittivity Conductivity (S / m) Acoustic property – Speed of sound (m / s) Acoustic property – Attenuation (dB / cm / MHz) Thermal conductivity (W / mK) Specific heat capacity J / kgKFibro glandular phantom 1 57.00 0.19 - - 0.21 2348Tumor phantom 49.56 0.83 - - 0.33 2960Fibro glandular phantom 2 62.00 0.67 1550 0.6 0.49 2960Deionized water 78.00 0.04 1500 0 0.62 4100 EXAMPLE 5: HYPERTHERMIA TREATMENT DELIVERY: Experiment I: The objective of this experiment was to demonstrate the ability to deposit power using phased array applicator at malignant tumor in the presence of thin polymeric sheet that serves as protective layer between tissue and DI water in the applicator i.e., secondary chamber or separation layer between tissue and DI water circulating in the phased array applicator. The phantom used was heterogeneous, to simulate fibroglandular breast tissue with localized primary malignant tumor having thermal and EM tissue properties inside a plastic container. The heating zone was midplane of phased array applicator. The measurement assessment was done using invasive temperature probes at and away from focal zone i.e., heating zone. The results are shown in FIG. 12A – FIG. 12E.Heterogeneous phantom was placed inside a plastic container for irradiation (FIG. 12A). Equal phase and equal power was delivered to all 12 channels, at a power level of 25 W at RF radiofrequency of 434 MHz. Heating duration was 7 minutes. Differential temperature rise was evident between probe placed at the centre compared to the offset probe at the end of irradiation. Plastic container provided thermal insulation between phantom and room temperature deionized water which resulted in heat buildup inside phantom and fast thermal rise in the invasive temperature probe data. EXAMPLE 6: US IMAGE GUIDANCE FOR 3D MODEL GENERATION TOWARDS HYPERTHERMIA TREATMENT PLANNING AND DELIVERY: Experiment II: The objective of this experiment was to test the ability to deposit power using phased array applicator at a malignant tumor in the absence of polymeric sheet, under ultrasound image guidance for 3D image reconstruction of phantom using multi-view ultrasound convex image data for segmentation and hyperthermia treatment planning. The phantom used was to simulate fibroglandular breast tissue with localized primary malignant tumor having thermal and EM tissue properties in direct contact with DI water. The heating zone was midplane of phased array applicator. The measurement assessment was done using invasive temperature probes at and away from focal zone i.e., heating zone. The experimental setup and position of probes are shown in FIG. 13A – FIG. 13D Treatment planning and delivery results are further presented. Equal phase and equal power was delivered to all 12 channels, at a power of 15 W at 434 MHz for 14 minutes. SAR distribution with distance at mid-slice is shown in FIG. 13C. Differential temperature rise is evident between the probe placed at the centre compared to the offset probe in FIG. 13D. Longer heating duration was observed compared to Example 4 measurements as phantom was cooled by the room temperature DI water in direct contact with the phantom. Experiment III: In another experiment the phantom wrapped in thin plastic film was placed inside the PA tank, and ultrasound image acquired for the phantom with tumor. 3D image reconstruction was done using ultrasound images and treatment planning was done under ultrasound image guidance. Treatment delivery and monitoring was done using fluoroptic thermometry (FOT) probes. Ultrasound image was acquired at 5 cm height (+ / 2.5 cm from heating plane, at every 5 degree rotation and total 30 views per plane. Image reconstruction procedure used is shown in FIG. 14A to FIG. 14C, and the reconstructed ultrasound images are shown in FIG. 15A to FIG. 15H. As illustrated in FIG. 15C, the compound image reconstruction flow process involves in reading the bin data which is further converted into 16384 sample along Z axis and 256 scan lines along X axis. The converted data is used for 380 X 380 B-Mode Image formation. The retrieved Yaw angle details with the sensors and B-mode image is combined together to obtain a 9 B-mode image with Yaw data of the slice considering 5th slice pointed at 0 degree. Save the resulting image matrix as a mat file by loading all 9 B-Mode images and summing them together element-wise. Combine the resulting images with slice obtained from different depth. EXAMPLE 7: HYPERTHERMIA TREATMENT DELIVERY AND ULTRASOUND IMAGE GUIDANCE FOR NONINVASIVE HYPERTHERMIA TREATMENT MONITORING The objectives of this experiment were to provide controlled hyperthermia treatment delivery using phased array and monitoring with ultrasound image guidance, depositing power at the centre of the phantom midplane using phased array applicator in homogenous breast phantom, and to monitor heating using ultrasound transducer - extract ultrasound based thermal map and compare with invasive temperature probe measurements. The phantom used was to simulate fibroglandular breast tissue having thermal, acoustic and EM tissue properties in contact with DI water. The measurement assessment was done using ultrasound convex transducer, and invasive temperature probes at and away from focal zone i.e., heating zone. The specifications of the ultrasound probe used for the experiments and data acquisition details are tabulated below in Table 4 and Table 5:Table 4: Specifications of the Ultrasound Probe used for ThermometryProbe type CurvilinearNumber of elements 128Operating frequency range 2 – 5 MHzCenter frequency 4 MHzField of view (degrees) 60Sampling frequency 65 MHzTable 5: Ultrasound Data Acquisition Details for Thermal ImagingData acquisition frequency 6 frames / min Maximum imaging distance (Axial) 190 mmMaximum imaging distance (Lateral) 228 mmOperating frequency 4 MHzAcquired data type Beamformed RF data – Binary int16 EXAMPLE 8:Comparison with other automated breast ultrasound (ABUS) imaging devices: The ABUS device INVENIA and ACUSON S2000 image acquisition are in supine position. SOFIA is in prone but the breast is compressed. In general, researchers on breast biomechanics have concluded that large scale motion of breast is relative to torso motion. In this research, a system and device were developed where image-guided treatment planning and microwave hyperthermia treatment may be done dynamically without varying the user’s (patient’s) torso position. In microwave hyperthermia treatment, the recumbent position was prone with the breast suspended in a cylindrical container filled with water. An ultrasound transducer was used to positioned along with the cylindrical container, making the treatment environment real-time and less complex. Table 6 below provides a comparison of the present system with other automated breast ultrasound (ABUS). Table 6: Different automated breast ultrasound (ABUS) imaging devices GE INVENIA SEIMENS ACUSON S2000 SOFIA HITACHI MEDICAL SYSTEMS VEPPAM (This work)Probe 15 cm high-frequency Reverse Curve™ (concave) linear array transducer 15.4 cm 14L5BV linear transducer 92?mm high-resolution linear transducer rotates around 18.4 cm circle Customisedconvex Probes. Three probes located 120 degrees apart in coronal plane.Depth 5 cm 6 cm trapezoid linear probe extends the field of view to more than 10?cm, and it can scan breast tissue up to a depth of 6?cm 10-15cmNo of elements 768 768 NA 128Pitch 0.2mm NA Frequency 6-15 MHz 6-15 MHz 5-10 MHz 2-5 MHzImage acquisition Transverse Plane Transverse Plane transducer automatically rotates around the breast in a clockwise circular motion to capture a 360° breast volume scan imageTransverse Plane - patient lies down prone with the bent contralateral leg positioned slightly rotated so that the breast flattens on the glass, with the nipple centered in the cone Coronal planeimaging platform is rotated + / ?22.5 degree about its default position in programmable steps of 1 degree or any desirable step size and RF US data from three US transducers are gathered in sequence by a DAQ board. Measurements are repeated as the US transducer platform is translated down for image acquisition at the new coronal slice.Image Processing Improved contrast resolution and identifies the acoustic clutter and eliminate Tissue equalization AlgorithmSpeckle ReductionNipple shadow compensationBreast border detectionChest wall detection Spatial compounding based tissue contrast enhancementTissue harmonic imagingSpeckle ReductionNipple shadow compensationReverberation removal algorithmGain Collection Algorithm – for adjustment of brightness variation artifacts caused by transducer channel-to-channel variations The scan is finished, raw data from the ultrasound device is sent to the SOFIA workstationHI Definition Tissue Harmonic Imaging and HI Compound Imaging, implemented into the system to improve the SOFIA image quality Spatial compound imaging of Multiview data gathered by the three US transducers reduce the scan time and provides sufficient coverage of the breast for imaging as well as thermal monitoring of the tumor target and health tissues during hyperthermia treatment.Beamformed RF data is analyzed for image formation employing compound imaging and image analysis algorithms for identifying and generating 3D model of the breast surface and tumor target. Optimizing the position of the ultrasound transducer for hyperthermia delivery: The location of ultrasound (US) transducer for ABUS and 3D model generation for hyperthermia treatment planning and delivery was identified. The same platform with phased array antennas and ultrasound transducer arrangement was used for image guided hyperthermia treatment planning and image guided treatment monitoring using US images gathered during hyperthermia delivery. Real time deep tissue thermometry algorithms were implemented for tissue temperature monitoring and to analyze real time radiofrequency (RF) US data and process the back scattered signals from US transducer for estimating temperature rise. EXAMPLE-8: IMAGE ACQUISITION- COMPOUND IMAGE FORMATION SEGMENTATION Image Reconstruction from different angle of view: In all ABUS device, B-Mode images acquired at different orientations or views are stiched with the information of US probe orientation / postion with reaspect to the co-ordinates of the user. Compound imaging technique has been used to reduce speckels, clusters and shadow artifacts. Since the antomical structure of breast has varing tissue composition it is difficult to devolpe coronal slice stacks from single view. Using Field II simulation software, a study was carried out to compare compound image stiching of the beamformed RF data. The reconstructed i.e., compound imaging, image quality was compared with different number of views or scan angles of US transducer. For a simulation purpose and analysis, a complex scatter plot was used shown in FIG. 17. The quality of compound B-mode ultrasound image reconstruction obtained for varying number of views is given in FIG 18. The results show that when the number of views increases the anamoly scructure in compound B-mode ultrasound image is similar to scatter plot. The compound image obtained with 15 degree probe rotation is the minimum step size needed for image reconstruction. Comparison of the original and compound imaging algorthm shows acceptably low artifacts for 15 degree rotation with structural similarity index of 97% with the input image for 24-view compound image reconstruction (last entry in FIG. 18). Table 7 provides details on pphysical dimensions of the image in the 2D scatter plot used for compound imaging and determining US imaging field of views.Table 7: Physical dimensions of the image in the 2D scatter plot used for compound imaging and determining US imaging field of viewsDiameter of outer circle in cm centered at (15,15) cm Diameter of inner circle in cm centered at (15,15) cm Anomaly location in cm (XZ plane) Anomaly diameter in cm7 6.4 15.5,15.5 3.75 Proposed US transducer arrangement – 3D US image guidance:For real time application, it was cumbersome to use stepper motor for programming the rotational stepping and moving the probe anterior and posterior to the breast. To avoid complications the stepper motor was replaced with actuators. And instead of rotating the US transducer / probe, the container with fixed arrangement of three US transducers spaced 120 degrees apart was rotated. The container may be rotated clockwise or anticlockwise up to 22.5 ? to obtain mutli-view images for complete coverage of the breast / imaging container. Simulations of the proposed US transducer arrangement for the phantom with inclusion was carried out for varying rotations of the imaging container. Simulation results for few cases are summarized in FIG. 19. It was observed that compound imaging outcome for 9 views of the phantom obtained for ?15 degree rotations of the container yielded similarity index of 96.02% with the input image. The similarity index improved to 97.74% for 15 views. 3D image reconstruction – US image guidance (ABUS): Following the imagining sequence for rotation, upward and downward movement of the US transducer alone excluding the imaging container was carried out for 3D image reconstruction of the phantom. FIG. 20 shows the 3D phantom used for simulations for assessing the feasibility of the image formation technique. The mid planes of the 3D US image data in coronal, axial and sagittal planes are shown FIG. 20A, FIG. 20B and FIG. 20C. FIG. 20D shows the segmentation results of compound imaging technique for the proposed ABUS imaging configuration that indicates the outer and inner boundaries of the phantom. For hyperthermia treatment planning, 3D compound US image data is proposed to be used for segmentation and identification of the external surfaces of the breast and tumour target. The segmentation results in FIG. 20D is obtained for 24 views of the 3D phantom with 15 degree uniform stepping. FIG. 21A-D showed US imaging and segmentation results of 3D compound US imaging for the proposed US transducer configuration with images gathered for 9 views (0, ?15? views per transducer). FIG. 22A-D showed US imaging and segmentation results of 3D compound US imaging for the proposed US transducer configuration with images gathered for 9 views (0, ?30? views per transducer). The results are better for 15 degree stepping than 30 degree. Results will be better for smaller rotational step but time consumed for scanning will increase. Thus, the optimal rotational stepping for ABUS was determined as 15? with three US transducers spaced 120? apart. Imaging container - Orientation for ABUS, sensor integration for positioning information The user can use remote control / program the container to rotate the imaging container rotationally to the desired rotation angle and move the US transducers alone simultaneously up and down using the mechanism shown in FIG. 23B. The 120 degree offset angle between the probes illustrated in FIG. 23A is verified with goniometer. For the above-mentioned US reconstruction methodology, probe orientation details with coordinate information (FIG. 23A) were required. FIG. 23C shown the origin for the treatment / imaging framework. The default position of the 1st US transducer with respect to origin of treatment frame is (0, y0, z0). When it is moved downward, it is shifted to a new position (0, y0, z0-?z). The translated position is gathered using IMU accelerometer sensor measurements and it is verified with ultrasound distance measurement sensor for improved accuracy in determining the US traducer location. After collecting the image data set by translation movement the treatment frame co-ordinate is rotate about z axis as shown in FIG. 23D. The rotation and translation movement for 3D US image acquisition is accomplished using linear actuator and gear mechanism. Rotation angle along z axis is measured in real time using IMU sensor gyroscope data. The angular velocity measurement and duration of the rotation calculated for the predefined rotation angle from the sensor data are analyzed to calculate the final rotational position of the sensor which is verified in turn by the camera image-based shift algorithm. Thus, real time location of US transducer is used for US compound image reconstruction. Sensor based location verification minimizes artefacts in the 3D US reconstructed data. Ideal location for placement of IMU sensor and camera was determined to be along the centre of rotational axis shown in FIG. 23E. A ring light was positioned for uniform distribution of light on the marker and to obtain good quality images for post processing. FIG. 23G and FIG. 23H show the angular velocity measurements of the actuator gathered from the sensors embedded in the treatment bed setup (FIG. 23F). EXAMPLE-9: Real-time temperature mapping and feedback-based hyperthermia treatment optimization: Real-time temperature mapping includes adaptive transducer positioning which includes the selection between single-plane alignment and multi-plane configuration, as well as their specific positions, is determined based on tumour segmentation data obtained from ultrasound imaging.In single-plane alignment, all three transducers are positioned to observe the same plane but from three distinct angles, ensuring a full-field temperature map of the breast along a chosen cross-section, useful to ensure localised heating at tumor target and monitoring temperature in healthy tissues.In multi-plane configuration, the three transducers are positioned at different heights, each observing the breast from a different angle to generate temperature maps at different depths. This configuration allowed temperature monitoring across multiple planes, with each transducer generating a thermal map of approximately at least half of the breast, useful to monitor healthy tissue temperature and control excitation delivered to phased array to minimize healthy tissue hotspots during targeted heating of the tumor target. Dynamic scanning capability, where all three transducers are synchronously moved from top to bottom of a treatment tank, capturing thermal data at periodic intervals to generate a 3D temperature map of the entire breast based on the 3D reconstruction algorithm proposed for tumour position mapping (Explained in the claim related ultrasound imaging for breast position estimation). Beamformed RF data acquisition, wherein RF data is periodically collected or obtained on demand to estimate temperature changes using thermal strain imaging methods, enabling non-invasive, high-precision thermal monitoring. To ensure the reliability of the thermal map, a confidence metric is computed based on a cross-correlation metric, allowing the retention of only the thermal estimates with high reliability, while less reliable regions of the thermal map are masked. Feedback-based treatment optimization, wherein the thermal map generated from the beamformed RF data is fed to the treatment planner as real-time feedback to dynamically adjust the amplitude and phase i.e., excitation of the antennas based on the treatment plan, ensuring precise and adaptive delivery of hyperthermia treatment for breast cancer. When the tumor was located at the center of the breast phantom, as identified through an MRI / CT or PET-CT scan. The breast phantom is then positioned inside the phased array breast cancer applicator and imaged using an ultrasound transducer. The ultrasound compound imaging algorithm confirms the tumor alignment in the hyperthermia treatment tank. Based on these ultrasound-derived inputs, the phased array antennas are excited with the required amplitude and phase to precisely target the tumor for hyperthermia treatment. The system estimates the temperature rise within the tumor and provide real-time feedback to the treatment planning application / algorithm, enabling continuous monitoring and dynamic adjustment of treatment parameters for optimal hyperthermia delivery i.e., selective power absorption at tumor target with minimal hotspots at the health tissues. FIG. 24A shows the experimental setup of thermal imaging of the breast. A fibroglandular tissue-mimicking cylindrical phantom (diameter: 10 cm, height: 20 cm) with electromagnetic properties (dielectric constant e_r = 62, conductivity 0.67 S / m) and acoustic properties (speed of sound 1550 m / s, attenuation 0.6 dB / cm / MHz) is positioned at the center of the phased array applicator tank, as shown in Fig. 6(a). All 12 antennas were connected to a 12-channel RF amplifier for hyperthermia delivery. Two invasive fiber optic thermometry probes were inserted into the cylindrical phantom for ground truth real-time temperature measurements. FIG. 24B show the probe position where the first probe is aligned with the center of the phantom and inserted up to a depth of 8 cm from the top of the phantom and the second probe is located at 4 cm offset distance from the first probe. A curvilinear ultrasound probe was positioned to image the central plane of the tumor for temperature estimation. All 12 antennas were provided an input power of 20 W and excited with equal phase for a duration of 15 minutes, generating a hotspot at the tumor location. Fiber optic thermometry continuously recorded data every 1 second. Ultrasound data was acquired before heating and then every 20 seconds during heating. The acquired beamformed RF data was used to estimate temperature maps. The temperature data from the invasive probes and the ultrasound-based temperature estimates were compared at the end of the heating experiment. FIG. 24C shows the temperature rise recorded by the invasive fiber optic probe, demonstrating a higher temperature rise at the tumor location (center) compared to the offset position. Generating thermal estimates using beamformed RF data: FIG. 5E outlines the process of estimating thermal maps from beamformed RF data where, temperature estimation is demonstrated along a single A-line corresponding to the center of the phantom. Estimating thermal maps included the steps of: Step 1: Acquiring RF Data: The temperature along this A-line was estimated using two sets of beamformed RF data whose B mode ultrasound images are shown in FIG. 24D and 24E, where one was acquired just before the start of the experiment FIG. 24D. Another was acquired immediately after heating is complete as denoted in FIG. 24E. From these two datasets, central A-lines are extracted for analysis. FIG. 24F displays the A-line data plotted on the same timescale, while FIG. 24G provides a magnified view, showing a shift in echo positions due to changes in the speed of sound caused by the temperature increase.Step 2: Estimating Cumulative Time Shift: As illustrated in FIG. 24H, using the principle: A shift in the signal in the time domain corresponds to a phase shift in the frequency domain, the cumulative time shift along the A-line is estimated. Step 3: Smoothing the Cumulative Time Shift Estimate: Since the cumulative time shift estimates are noisy, they are fitted to a polynomial for smoothing. FIG. 24I shows the cumulative time shift estimate after polynomial fitting.Step 4: Computing the Local Time Shift (Incremental Time Shift Map): The cumulative time shift estimate was differentiated to obtain the local (incremental) time shift map along the A-line. A gradient operation is applied to the cumulative time shift maps. FIG. 24J presents the gradient of the polynomial-fitted cumulative time shift estimate, where negative values are set to zero under the assumption that only heating occurred (without cooling).Steps 5 to 7: Repeating the Process for All A-Lines: Steps 1 to 4 were repeated for all A-lines in the acquired beamformed RF data. The incremental time shift is then spatially low-pass filtered. The filtered image is scaled to incremental temperature change based on a calibration constant. FIG. 24K shows the temperature estimate along the A-line, following Steps 5 to 7. Temperature estimates beyond a 70 mm depth are masked due to a poor signal-to-noise ratio (SNR).FIG. 24 L and FIG. 24M illustrates the temperature rise estimated using the ultrasound-based technique, where: FIG. 24L presents the thermal map without masking unreliable temperature estimates. FIG. 24M presents the thermal map with unreliable temperature estimates masked, ensuring a more reliable thermal representation. Table 8 compares the temperature rise recorded by the invasive probe with the ultrasound-based temperature estimates, showing a high correlation between the two measurements. Likewise, thermal maps can be estimated by acquiring RF beamformed data from all the 3 ultrasound transducers to generate thermal in single plane configuration or multi plane configuration or a 3D thermal imaging. Table 8: Comparison of temperature estimates of invasive probe and ultrasound estimation Temperature rise measured by FOT Temperature rise measured by ultrasoundFOT 1 7 ? 6.6 ?FOT 2 5 ? 4.8 ?

Claims

,CLAIMS:We claim:

1. A phased array applicator device (100) for delivering localized hyperthermia to a tissue using image guidance, the device comprising:a hyperthermia applicator tank (101) having a wall and an open top, the tank having a central axis (102) thereof, the wall embedded with a plurality of patch antennas (103) arranged in at least two rings (104) and three equiangularly placed windows (105) placed between the patch antennas and covered with a material configured to allow ultrasound propagation, the tank (101) configured to hold a dielectric medium (106) surrounding an organ (107) and adapted to rotate about its axis and orient the plurality of patch antennas (103) to selectively deliver microwave hyperthermia to a target tissue (108) within the organ (107);the plurality of patch antennas (103) positioned in the applicator tank (101) surrounding the organ (107) and each antenna having an associated water bolus, the antennas configured to provide power deposition by selective switching and to regulatetarget tissue temperature to a hyperthermia range; andthree ultrasound transducers (109) placedbehind the windows (105), the transducers (109) adapted to generate ultrasound beams and gather images of the organ (107), wherein,on rotation of the applicator tank (101), the antennas (103) are configured to irradiate the target tissue (108) while the plurality of ultrasound transducers (109) are concurrently configured to move vertically up or down for real-time scanning of the organ (107) and provide ultrasound imaging of the organ (107) including the target tissue (108) to generate 3D organ imaging and 3D tissue thermal data, wherein the antennas areswitchable to provide microwave heating to the target tissue (108) in response to control inputs based on the ultrasound imaging data and the 3D tissue thermal data.

2. The device as claimed in claim 1, wherein the dielectric medium (106)in the applicator tank (101)is temperature-controlled deionized (DI) water.

3. The device as claimed in claim 1, wherein the windows (105) are made of polyvinyl chloride with a thickness of 1-2 mm.

4. The device as claimed in claim 1, wherein the patch antennas (103) in each ring number from three to six.

5. The device as claimed in claim 4, wherein the patch antennas (103) comprise three rings having four antennas each at a spacing of 90°, and wherein each ring of antennas is staggered at 45? with reference to the adjacent ring.

6. The device as claimed in claim 4, wherein the patch antennas (103) comprisethree rings, the top and bottom rings having three antennas each at a spacing of 120° and the middle ring has six antennas , the antennas being offset by a predetermined angle with reference to the top and bottom rings.

7. The device as claimed in claim 4, wherein the patch antennas (103) comprisetwo rings, the top and bottom rings having six antennas each, the antennas in each ring placed one above the other without angular offset.

8. The device as claimed in claim 1, wherein each patch antenna (103) comprises a patch (110), a cavity (111) with deionised water and a threaded hole (112) on anoutside surface of the cavity to attach an SMA connector.

9. The device as claimed in claim 1, wherein the patch antennas (103) include individual or shared water bolus.

10. The device as claimed in claim 1, wherein each of thepatch antennas (103) is configured to operate at varying phase or power.

11. The device as claimed in claim 1, wherein the patch antennas (103) are configured to operate at 433 MHz or lower frequencies.

12. The device as claimed in claim 1, wherein the ultrasound transducers (109) are configured to operate at over 2-5 MHz and provide a depth of coverage of 15-20 cm in tissue.

13. The device as claimed in claim 1, wherein the ultrasound transducers (109) comprise an array of linear or curvilinear convex transducers.

14. A system (200) for treating breast tumours in a subject by optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping, the system comprising:a platform (201) operable to support a user in prone position to receive microwave radiation from an applicator device, the platform having a breast plate (202) with openings configured to accommodate breasts of the subject in pendant orientation, the platform having a longitudinal platform axis, and a horizontal platform axis at 90? to the longitudinal along the breast plate;the phased array applicator device (210), mounted on an applicator positioning unit (220), the device (210) comprising a hyperthermia applicator tank (211) integrated with a plurality of ultrasound transducers (212) to generate ultrasound imaging data, wherein the applicator tank has a plurality of patch antennas (213) adapted to hold a dielectric medium (214) surroundinga breast(215) to selectively deliver microwave hyperthermia to a target tissue (216) therewithin; the applicator positioning unit (220) having first (221a), second (221b) and third (221c) actuators, the first actuator (221a) configured to move the applicator device (210) along the horizontal axis, the second actuator (221b) configured for vertical movement of the applicator device (210), and the third actuator (221c) configured for 45? angular rotation of the applicator device (210) about an axis thereof, an RGB camera (222), an inertial measurement unit (IMU) sensor (223) and a ring light (224) to illuminate the applicator tank (211), and a control unit (225) configured to receive control inputs from the camera (222) and the IMU sensor (223) and provide control signals to the actuators (221a, 221b, 221c) for applicator positioning;a graphical user interface (230) enabling visualization of the ultrasound imaging data, the thermal maps and the measured microwave radiation over the scanned area along with a visible range thereof;a water conditioning unit (240) configured to circulate water and regulate temperature of the dielectric medium (214);a controller (250) comprising a computer having a processor, memory and an integrated power source (251), communicably connected to the phased array applicator device (210), and the applicator positioning unit (220), the controller (250) comprising:an ultrasound imaging module (252) integrated with the applicator device (210) and configured to provide real-time imaging of the organ based on the ultrasound imaging data for thermal map generation;a thermal imaging module (253) configured to generate real-time thermal maps of the target breast (215) based on 3D beam formed radiofrequency (RF) data from proximally positioned ultrasonic transducers (212);a visible image processing module (254) configured to extract visible image data and position the breast (215);a regulator (255) configured to control the phase and power of microwave energy, regulate functions of the phased array applicator device (210), the applicator positioning unit (220), the graphical user interface (230), the ultrasound imaging module (252), the thermal imaging module (253), and the visible image processing module (254) to determine the targetlocation to deliver heating and to control the water conditioning unit (240) to regulate the temperature of the dielectric medium (214); anda feedback unit (256) configured for fine tuning delivery of microwave energy to the target location based on analysis of ultrasound imaging data.

15. The system as claimed in claim 14, wherein the applicator positioning unit (220) is configured for:horizontal and rotational movement of theapplicator device (210) and concurrent vertical movement of the ultrasound transducer to adjust depth position of the breast (215) based on the ultrasound imaging data; andoptically determining position, scanning area of the breast (215) and to capture real time images of the breastusing the camera (222).

16. The system as claimed in claim 14, wherein the platform (201) includes a frame (2020) to support the applicator positioning unit (220).

17. The system as claimed in claim 14, wherein the platform(201) includes resting panels to the user at contact points such as head (203), chin (204), hands (205), torso (206) and feet (207).

18. The system as claimed in claim 17, wherein the resting panels comprise variable cushioning densitiesto comfortably support the user.

19. The system as claimed in claim 14, wherein the platform(201) includes measurement and reference points (208) to record the position of the user.

20. The system as claimed in claim 14, wherein the water conditioning unit (240) is configured to supply or to top up the dielectric medium (214) and to regulatetemperature thereof.

21. The system as claimed in claim 14, wherein the power source (251) includes a power amplifier module configured to excite the antennas in the phased array applicator device (210).

22. The system as claimed in claim 14, wherein the system includes a laser unit (260) to generate a laser beam for positional calibration.

23. The system as claimed in claim 14, wherein the breast plate (202) includes a concealer (209) configured to conceal one of the breasts from receiving microwave radiation from the applicator device during operation.

24. A method (300) for optimizing organ position within a phased array applicator device and providing image guided localized hyperthermia with real-time temperature mapping, the method comprising the steps of:providing (301) the phased array applicator device, the device comprising an applicator tankwith a plurality of ringsaffixed with a plurality of patch antennas adapted to hold a dielectric medium surroundinga target organ to selectively deliver microwave hyperthermia to a target tissue therewithin, and a plurality of ultrasound transducersinterspersed therebetween to generate ultrasound imaging data;providing (302) an applicator positioning unit adapted to move the applicator device, the applicator positioning unit comprising first, second and third actuators, a camera, an IMU sensor and a ring light, the camera and IMU sensor providing control inputs to a control unit;placing (303) a subject on a platform having openings configured to accommodate the target organ of the subject;optimizing position (304) of a target tissue within the target organ at the focal point of the applicator device, comprising:positioning (305) the phased array applicator devicewith respect to the subject;placing (306) thetarget organ of the subject within the applicator tank;recording (307) control signals for the first, second and third actuators required for positioning thetarget organ of the subject;generating (308) ultrasound beams by the plurality of ultrasound transducers and receiving and acquiring (309) multi-view pre-operative ultrasound image data of the target organ inan ultrasound imaging module from the received ultrasound beams;capturing (310) a 3D model of the applicator using the camera and IMU sensor data to provide locations of the plurality of patch antennas;constructing (311) a pre-operative 3D ultrasoundimage of the target organ from the acquired multi-view pre-operative ultrasound image data by image compounding in the ultrasound imaging module; performing (312) segmentation of the pre-operative 3D ultrasound image of the target organ by the ultrasound imaging module to provide a 3D segmented model of the target organ;identifying (313) position of healthy and tumorous tissue volumes in the target organ by computing the 3D segmented model by a controller;providing (314) image guided localized hyperthermia to the target tissue with real-time temperature mapping using the phased array applicator device, comprising:pre-operative positioning (315) of the target tissue by the controller, comprising:providing (316) the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model to the controller;importing (317)the image and model inputs to an EM simulation environment;rotating (318) the applicator to optimally position the tumorous tissue volume fortreatment monitoring and delivering microwave hyperthermia; determining (319) optimal phase and power to be delivered by each of the patch antennas based on the ultrasound image data;feeding (320) a microwave field distribution in the 3D segmented model in a regulator; andproviding (321) the data of optimal positioning, optimal phase and power, and the microwave field distribution to determine pre-operative positioning of the target tissue;providing (322) image guided localized hyperthermia with real-time temperature mapping, comprising:retrieving (323) recorded control inputs for the first, second and third actuators for thetarget organ;retrieving (324) the pre-operative 3D ultrasound image, the 3D model of the applicator and the 3D segmented model for thetarget organ;retrieving (325) the data of optimal positioning, the optimal phase and power, and the microwave field distribution to determine positioning of the target tissue to deliver and guide microwave excitation;capturing (326) beamformed radiofrequency data from pre-operative 3D ultrasound images, the 3D applicator model and the 3D segmented model in a thermal imaging module;generating (327) an ultrasound- thermal map from the acquired beamformed radiofrequency data;positioning (328) the ultrasound transducers at the optimal positions based on the generated ultrasound thermal maps;guiding and monitoring (329) the microwave radiation through an optimal combination of patch antennas based on the retrieved data; capturing (330) multi-view post-operative ultrasound images to provide beamformed radiofrequency data;generating (331) post-operative ultrasound- thermal map from the acquired beamformed radiofrequency data; andproviding real-time feedback (332) for post-operative optimal heating of the target tissue in a feedback unit.

25. The method as claimed in claim 24, comprising gathering B-mode images of the organ via the plurality of ultrasound transducers.

26. The method as claimed in claim 24, comprising rotating the applicator tank up to 45° clockwise or counterclockwiseto obtain multi-view images of the organ.

27. The method as claimed in claim 24, wherein acquiring(309) multi-view pre-operative ultrasound image data comprises combining acquired B- mode images at different views with different orientations of the ultrasonic transducers with respect to coordinates of the target organ.

28. The method as claimed in claim 24, wherein generating ultrasound- thermal maps (327) from acquired beamformed radiofrequency data comprises: acquiring (3271) beamformed radiofrequency of the target organ in the thermal imaging module;estimating (3272) a cumulative time shift along each A-line corresponding to the target organ of the acquired beamformed radiofrequency data with respect to a previous frame;smoothing (3273) the cumulative time shift estimate by curve fitting and low pass filtering on the cumulative time shift map;estimating (3274) gradient of cumulative time shift map along each A-line;filtering (3275) the gradient of cumulative time shift map using low pass filters;accumulating (3276) gradient of cumulative time shift maps; andmapping (3277) to temperature change using calibration.

29. The methodas claimed in claim 24, wherein determining optimal phase and power (319) to be delivered by each of the patch antennas comprises calculating power and phase of the microwave excitation to be given to individual antennas in the applicator device such that power deposition inside the tumor target is maximized and power deposition in healthy tissues is minimized.

30. The methodas claimed in claim 24, wherein the method (300) comprises circulating the dielectric medium by a water conditioning unit for regulating temperature of the applicator tank during operation.

31. The method as claimed in claim24,wherein positioning (328) the ultrasound transducers at the optimal positions based on the generated ultrasound thermal maps comprises:obtaining (3281) target tissue segmentation data from the ultrasound imaging unit;positioning (3282) the plurality of ultrasonic transducers by selecting single or multi-plane alignment or positions of the ultrasonic transducers based on target tissue segmentation data; and guiding (3283) the microwave radiation with a switching matrix for selecting optimal patch antennas based on defined targettissue.

32. The methodas claimed in claim 24, wherein providing real-time feedback (332) for post-operative optimal heating of the target tissue comprises:calculating (3321) location, intensity and extent of heating from the ultrasound image data;comparing (3322) with treatment predictions performed by the controller;updating(3323) power and phase settings of the phased array applicator device to compensate for offset in location;reducing (3324) the heating at the tumour or overheating at healthy tissue volume;selecting the optimal settings among the potential settings and updating regulator settings;providing (3325) microwave radiation with updated regulator settings;monitoring (3326) temperature change in the post-operative ultrasound- thermal map; andcontinuing (3327) optimized regulator settings during treatment.

33. The method as claimed in claim 24, wherein the method comprises displaying the real-time scanned images of the organ in a graphical user interface (GUI).(Dr. V. SHANKAR IN / PA-1733)For and on behalf of the Applicants