Description:FIELD OF THE INVENTION
[0001] Embodiments of the present disclosure relate direct ultrasound wave- based removal of objects identified in a region of interest, and more specifically to a non-invasive method of removing identified objects without causing damage to the surrounding area around the object.

BACKGROUND OF THE INVENTION
[0002] Generally, light and sound have been used in the field of medical diagnostics and both light and sound have been finding newer roles in the medical diagnostic and medical intervention. Normally removal of objects within a tissue requires surgical procedures, include sharp objects employed for cauterization to stop bleeding, crushing, burning and dislodging of pathologies that appear as mechanical inhomogeneities such as lesions, thrombi or stones. Typically, focused ultrasound has been used in surgical procedures, where focusing through tissue is not compromised by scattering as much as with light. In existing ultrasound applicators, sound is normally produced via a secondary effect of electrical arcing. The sound thus generated is normally multifrequency, and consequently, the focal region of the sound wave generated may not be sharp. High power ultrasound transducers on concave surfaces provide ‘quasi-monochromatic’ waves with sharp focal regions dictated by the curvature of the concave scaffolding. Such a focused ultrasound intensity generates a force and has been employed in diagnosis as a ‘remote palpation device’ in non-invasive elastography. The current method when used in non-invasive surgery tend to damage the surrounding tissue around an object identified in the region of interest and may result in excessive damage to tissues as well. The present disclosure ameliorates these disadvantages.

SUMMARY OF THE INVENTION
[0003] Embodiments of the present disclosure relate to a method for pulverizing a first object (for example a stone such as a calcium carbonate formation) located within a second object (for example Kidney or gall bladder, which is a tissue). An embodiment of the present disclosure includes detecting a resonant frequency (f0) associated with a first object, wherein the first object located within a second object, and the second object being larger than the first object. In an exemplary (exemplary in this disclosure may be also read as illustrative and may be interchangeably used) case the first object may be a stone, such as a calcium carbonate formation within the second object. In another exemplary case, the second object may be a tissue such as a gallbladder or kidney or liver. It should be obvious to a person of ordinary skill in the art the examples provided above are only for purpose of illustration and there could be various other objects and scenarios where the embodiments of the present disclosure may be used to pulverize the unwanted object (first object) without causing damage to the second object, and all such variation fall within the scope of the present disclosure. In an embodiment, two ultrasound waves of a first frequency f1 and a second frequency f2 are used, wherein for example the frequency f1 is “ X” MHz and the frequency f2 is “X+Y” MHz, where “Y” is in the range of a few KHz, and typically “Y” chosen such that it matches with the dominant resonant frequency f0 of the object.
[0004] A further embodiment includes driving the object with an acoustic force at frequency (?f = f2 - f1)and varying the second frequency f2 , so that ?f matches the resonant frequency (f0) associated with the first object. It should be obvious to a person of ordinary skill in the art that each object has its own resonant frequency, and depending on the object the resonant frequency may be detected; which may be used for classifying the object. An embodiment includes pulverizing the first object by adjusting input Ultrasound power, wherein the object is pulverized when the frequency ?f equals the resonant frequency f0 of the first object. Other embodiments are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The detailed description is described with reference to the accompanying figures. Features, aspects, and advantages of the subject matter of the present disclosure will be better understood with regard to the following description and the accompanying drawings. The figures are intended to be illustrative, not limiting, and are generally described in context of the embodiments, and it should be understood that it is not intended to limit the scope of the disclosure to these particular embodiments. In the figures, the same numbers may be used throughout the drawings to reference features and components. In order that the present disclosure may be readily understood and put into practical effect, reference will now be made to exemplary embodiments as illustrated with reference to the accompanying figures. The figures together with detailed description below are incorporated and form part of the specification, and serve to further illustrate the embodiments and explain various principles and advantages.
[0006] Figure 1 is an illustration of an exemplary system in accordance with an embodiment of the present disclosure.
[0007] Figure 2 is an exemplary method illustrating of generating dual ultrasound waves and focusing the dual ultrasound waves on an object in accordance with a preferred embodiment of the present disclosure.
[0008] Figure 3 is an exemplary method illustrating use of dual ultrasound waves for pulverizing an object in accordance with an embodiment of the present disclosure.
[0009] Throughout the drawings, identical reference numbers designate similar, but not necessarily identical elements. The figures as disclosed herein are not necessarily to scale, and the size of some parts may be exaggerated to more clearly illustrate the example shown. Moreover, the drawings are meant to only be provided as examples and/or implementations consistent with the description, and the description may not be limited to the examples and/or implementations provided in the drawings.

DETAILED DESCRIPTION
[0010] The following describes technical solution in exemplary embodiments of the subject matter of the present disclosure with reference to the accompanying drawings. In this application as disclosed herein, "at least one" means one or more, and "a plurality of" means two or more. The term "and/or" describes an association relationship for describing associated objects and represents that three relationships may exist. For example, A and/or B may represent the following cases: Only A exists, both A and B exist, and only B exists, where A and B may be singular or plural. The character "/" usually indicates an "or" relationship between the associated objects. "At least one item (piece) of the following" or a similar expression thereof means any combination of the items, including any combination of singular items (piece) or plural items (pieces). For example, at least one item (piece) of a, b, or c may represent a, b, c, a and b, a and c, b and c, or a, b, and c, where a, b, and c each may be singular or plural.
[0011] It should be noted that in this application articles “a”, “an” and “the” are used to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. The terms “comprise” and “comprising” are used in the inclusive, open sense, meaning that additional elements may be included. It is not intended to be construed as “consists of only”. Throughout this specification defined above, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps. The term “including” is used to mean “including but not limited to”. “Including” and “including but not limited to” are used interchangeably. In the structural formulae given herein and throughout the present disclosure, the following terms have been indicated meaning, unless specifically stated otherwise.
[0012] Unless otherwise defined, all terms used in the disclosure, including technical and scientific terms, have meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions are included for better understanding of the present disclosure. The term ‘about’ as used herein when referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of ±10% or less, preferably ±5% or less, more preferably ±1% or less and still more preferably ±0.1% or less of and from the specified value, insofar such variations are appropriate to perform the present disclosure. It is to be understood that the value to which the modifier ‘about’ refers is itself also specifically, and preferably disclosed.
[0013] It should be noted that in this application, the terms such as "example" or "for example" or “exemplary” are used to represent giving an example, an illustration, or description. Any embodiment or design scheme described as an "example" or "for example" in this application should not be explained as being more preferable or having more advantages than another embodiment or design scheme. Exactly, use of the word such as "example" or "for example" is intended to present a related concept in only a specific manner.
[0014] In the embodiments of the present subject matter that "B corresponding to A" indicates that B is associated with A, and B can be determined based on A. However, it should be further understood that determining B based on A does not mean that B is determined based on only A. B may alternatively be determined based on A and/or other information. In the embodiments of this application, "a plurality of" means two or more than two. Descriptions such as "first", "second" in the embodiments of this application are merely used for indicating and distinguishing between described objects, do not show a sequence, do not indicate a specific limitation on a quantity of devices in the embodiments of this application, and do not constitute any limitation on the embodiments of this application.
[0015] Embodiments of the present disclosure relate to a method for pulverizing a first object (for example a stone such as a calcium carbonate formation) located within a second object (for example Kidney or gall bladder, which is a tissue). An embodiment of the present disclosure includes detecting a resonant frequency (f0) associated with a first object, wherein the first object located within a second object, and the second object being larger than the first object. In an exemplary case, the first object may be a stone, such as a calcium carbonate formation within the second object. In another exemplary case, the second object may be a tissue such as a gallbladder or kidney or liver. It should be obvious to a person of ordinary skill in the art the examples provided above are only for purpose of illustration and there could be various other object and scenarios where the embodiments of the present disclosure may be used to pulverize the unwanted object (first object) without causing damage to the second object, and all such variation fall within the scope of the present disclosure. In an embodiment, two ultrasound waves of a first frequency f1 and a second frequency f2 are used, wherein for example the frequency f1 is “ X” MHz and the frequency f2 is “X+Y” MHz, where “Y” is in the range of a few KHz, and typically “Y” is chosen such that it matches with the resonant frequency f0 of the object.
[0016] A further embodiment includes driving the object with an acoustic force at frequency (?f = f2 - f1) and varying the second frequency f2 , so that ?f matches the resonant frequency (f0) associated with the first object. In an embodiment, the first frequency f1 is kept constant and the second frequency f2 is varied so that ?f matches the resonant frequency (f0) associated with the first object. It should be obvious to a person of ordinary skill in the art that each object has its own resonant frequency and depending on the object, the resonant frequency may be detected. An embodiment includes pulverizing the first object by adjusting an input Ultrasound power, wherein the object is pulverized when the frequency ?f equals the resonant frequency f0 of the first object. In an exemplary case, a resonant mode may help in setting up large oscillations leading to cleavage and powdering, which have not been acted upon, and no progress is made either in improving the sharpness of the ultrasound scalpel or developing a machine for non-invasive removal of obstructions of objects located within a tissue, such as kidney stone. In an exemplary case, the present disclosure relates to the formation, and electronic control of the curvature of the ultrasound beams, so as to guide the focal region to the pathology within in a non-invasive manner. Though the exemplary embodiment presented herein in the embodiments of the present disclosure, indicate medical use, it should be obvious to a person of ordinary skill in the art that such techniques may be used in other technical fields as well and all such variations fall within the scope of the present disclosure. In an case, by varying the forcing frequency, forced resonance of the vibrating focal region is observed, wherein with increased amplitudes of vibration, kidney stones are pulverized (broken) to pieces at intensities 40%- 50% less than needed otherwise. In an exemplary case, the force may be confined to the narrow focal region, thus avoiding collateral damage to the surrounding area of the object.
[0017] In an exemplary case, the method includes generating a first signal at a first frequency (f1) and a second signal at a second frequency (f2). In an example case, the first signal is generated at first source S1 having a frequency f1, and second signal is generated at second source S2 having frequency f2. In an example case, the method includes focusing the first signal at frequency f1 and the second signal at frequency f2 on the first object wherein the first object is located within a second object. In an example case as mentioned previously, the first object may be a stone and the second object may be a tissue such as a gallbladder or kidney. As mentioned previously, the above-mentioned examples are only for purpose of illustration and the technique of the present disclosure may be used in any field of technology wherein a first object located within a second object needs to be removed or pulverized.
[0018] In an example case, the second frequency (f2) of the second signal is a sum of the first frequency (f1) of the first signal and the resonant frequency (f0) associated with the first object. In an example case, the first signal (f1) and the second signal (f2) produce beat frequencies, wherein the beat frequencies are produced by interferometric mixing of the first signal at a frequency f1 and the second signal at a frequency f2 in first object, wherein the first object is located within the second object. In an example case, mixing of the first signal and the second signal produces waves with frequencies that include a sum frequency ?f = f1 + f2, and a difference frequency ?f = f2 - f1.
[0019] In an example case, the difference frequency ?f when equal to the resonant frequency f0 produces vibrations, wherein these vibrations may be typically large vibrations, and these vibrations are used to pulverize only the first object without affecting any surrounding regions in the second object. In an example case, the first signal (f1) and the second signal (f2) are in the range of 1MHz to 7 MHz at the source. In an example case, the difference frequency ( ?f) is restrained in the range of 50 Hz to about 100 kHz.
[0020] An example case includes a system for generating difference frequency (?f) sound wave. In an example case, a first ultra-stable digital function generator with a first channel (S1) is configured to generate a first signal at a first frequency (f1), and the same ultra-stable digital function generator, which has a second channel (S2) is configured to generate a second signal at a second frequency (f2). In an example case, the second frequency (f2) is a sum of the first frequency (f1) and the resonant frequency (f0) associated with the first object identified, wherein the first object is located within a second object. An example case includes, focusing the first signal at frequency f1 and the second signal with frequency f2 on a first object, wherein the first object is located within a second object, thereby generating an ultrasound wave with a difference frequency (?f), wherein the sound wave with the difference frequency is equivalent to a resonant frequency (f0) of the first object. In an example case, the difference frequency is configured to pulverize the first object by adjusting input Ultrasound power, when the difference frequency (?f) equals the resonant frequency f0 of the first object.
[0021] In an example case, the second frequency (f2) of the second signal is a sum of the first frequency (f1) of the first signal and the resonant frequency (f0) associated with the first object 165. In an example case, the first signal (f1) and the second signal (f2) produce beat frequencies, wherein the beat frequencies are produced by interferometric mixing of the first signal at a frequency f1 and the second signal at a frequency f2 in first object, wherein the first object is located within the second object.
[0022] In an example case as mentioned previously, mixing of the first signal at frequency f1 and the second signal at frequency f2 produces waves with frequencies that are a sum frequency, ??f = f1 + f2, and a difference frequency, ?f = f2-f1. In an exemplary case, the difference frequency ?f when equivalent to the resonant frequency f0 produces vibrations pulverizing only the first object without affecting any surrounding regions in the second object.
[0023] Reference is now made to Figure 1, which is an illustration of an exemplary system in accordance with an embodiment of the present disclosure. System 100 is an exemplary illustration of a means to produce ultrasound waves in accordance with the requirements of the embodiments of the present disclosure. It should be obvious to a person of ordinary skill in the art that various other techniques may be used to produce the ultrasound waves and all such variation fall within the scope of the present disclosure. System 100 includes a source 110 for generating ultrasound waves. First ultra-stable digital function generator with a first channel (S1) is configured to generate a first signal at a first frequency f1. The second channel of the same ultra-stable digital function generator (S2) is configured to generate a second signal at a second frequency f2. The second frequency f2 generated at second channel is a sum of the first frequency f1 and the resonant frequency f0, wherein the resonant frequency f0 is associated with first object 165. Resonant frequency f0 may vary depending on the first object and it should be obvious to a person of ordinary skill in the art the resonant frequency f0 of first object 165 may be determined prior and added to the second channel such that the ultrasound wave from second channel S2 has a second frequency f2 = f1+ f0. A primary source of the generating the waveforms is generator 110 where the ultrasound waves are generated to drive two ultrasound transducers 140, the first wave with frequency f1 being routed to transducer T1 and the second wave with frequency being routed to transducer T2. In an example case, a single clock signal is used for synchronous generation of sinusoidal signals at 1100000 Hz and 1101200 Hz, which requires the oscillators to work ultra-stable in frequency. In an embodiment, transducers 140 containing first transducer T1 and second transducer T2 may be placed at varying angles and preferably between 60 degree to about 120 degrees. Waves from source S1 and source S2 are routed via amplifier unit 120, containing two amplifiers, a first amplifier A1 coupled to source S1 and second amplifier coupled to source S2. Amplifier unit 140 amplifies the waves from the source. Amplified signals from amplifier unit 120 are routed to impedance matching unit 130 containing a first impedance unit I1 and a second impedance unit I2, following which the waves with frequency f1 is sent to transducer T1 and wave with frequency f2 is sent to Transducer T2. Impedance matching unit 130 is where the input impedance and the output impedance of the given signals are designed to reduce signal reflection and maximize the power transferred to first transducer T1 and second transducer T2 of the transducer unit 140.
[0024] The two ultrasound waves, the first wave with frequency f1 and the second wave with frequency f2 are focused on first object 165 which is within a second object 160, and the intersection region of the cross 162 indicates the region of interest (ROI) where the two ultrasound waves are focused. Focusing the first signal with frequency f1 and the second signal with frequency f2 on a first object 165 located within a second object 160, will generate beat frequencies in addition to the two original signal of frequency f1 and frequency f2, a third signal with a frequency which is a sum frequency ?f = f1 + f2, and a fourth signal with a frequency which is a difference frequency ?f = f2-f1. The first signal with frequency f1, the second signal with frequency f2 and the third signal with frequency ?f are all high frequency signals which will not affect the first object 165 and/or the second object 160. The fourth signal with frequency ?f which is the difference of the first frequency f1 and the second frequency f2, is a low frequency wave which can be associated with a resonant frequency f0 of the object 165. Due to the difference frequency ?f being equivalent to the resonant frequency f0, high-amplitude vibrations are setup in the first object 165 and pulverize first object 165.
[0025] In an example case, if the first object is kidney stone and the second object is a kidney, the difference frequency is equivalent to the resonant frequency of the kidney stone, thereby causing the kidney stone to vibrate and get pulverized into a powder form without affecting the surrounding tissue of the kidney. The technique when used in non-invasive surgical procedures this finds impactful advantages as it does not cause any damage to the surrounding tissue and is effective in removal of kidney stones. It should be obvious to a person of ordinary skill in the art that this technique may be used for clearing object located within tissues without causing damage to any tissue. In another example, malignant tissue can be pulverized or killed using the same technique by using resonant frequency such that the malignant tissue is completely removed and/or eliminated via non-invasive technique in accordance with the present disclosure.
[0026] Reference is now made to Figure 2, which is an exemplary method of generating dual ultrasound waves and focusing the dual ultrasound waves on an object in accordance with a preferred embodiment of the present disclosure. In step 210, a region of interest 162 is identified, which is related to the presence of first object 165. First object 165 needs to be pulverized. In step 220, the resonant frequency, f0 , of the first object is determined. In step 230, a first signal with a frequency f1 and a second signal with a frequency f2 are generated from a source, wherein the frequency of the second signal f2 – f1 = f0, where f0 is the resonant frequency of the first object 165. In step 240, the first signal with frequency f1 and the second signal with frequency f2 are focused on the first object 165, wherein first object 165 is located within second object 160. Other details are described with respect to Figure 1 above.
[0027] Reference is now made to Figure 3, which is an exemplary method of using the dual ultrasound waves for pulverizing an object in accordance with an embodiment of the present disclosure. In step 310 first signal with frequency f1 from transducer T1 is taken. At a simultaneous instant of time, in step 320 a second signal with frequency f2 from transducer T2 is taken. Both the first signal and the second signal in Step 330 are focused on the ROI 162 of the first object 165, wherein the first object is located within the second object. In step 340, because of the first signal and the second signal being focused on the object beat frequencies are generated along with the first signal and the second signal. The beat frequencies are, a third signal with frequency being the sum of the frequency of first signal and second signal, ?f = f1 + f2, and a fourth signal with a frequency being the difference of the first signal and second signal, ?f = f1- f2. In step 350, the difference frequency ?f being the same as the resonant frequency f0 sets up vibrations in the first object 165, pulverizing the first object 165 without causing any damage to the second object 160. This has been elaborated with respect to Figure 1 previously.
[0028] In an example case, it is well known that Ultrasound machines have a long history of diagnostic imaging applications in medicine. However, their intervensive, therapeutic applications are, at the best, only partially realized. Embodiments of the present disclosure relate to an intervensive application of ultrasound beams to selectively fragment and powder kidney stones and can be extended to other applications such as gallbladder stones, thrombi blocking veins leading to life-threatening disabilities such as stroke, liver cirrhosis or heart failure, and to nonsurgical burning of malignant lesions. It should be obvious to a person of ordinary skill in the art that embodiments of the present disclosure find application in a number of different non-invasive cures for human and animal use.
[0029] In an example case, the system uses two ultrasound array transducers, which also produce a 2D cross-sectional image of the kidney. In an example case, since ultrasound works at many MHz in medical applications and the object of interest are kidney stones, which have resonant modes in kHz or less, this dual-beam approach to insonify the selected region with a mixed difference-frequency acoustic wave has been used. In an example case, a part which oscillates with the sum of frequencies (which is still in the MHz range) is used to image and identify the inhomogeneities which may be the kidney stone with location. In an example case, the linear arrays are made to produce two cylindrical beams which focus energy on the stone. In an example case, by adjusting the ultrasound frequencies, resonant vibrations are set up in the stone, thereby producing mechanical failure via a localized crushing of the stone into smaller fragments. In an example case, by a slight increase of the ultrasound intensity, the stone can be powdered or pulverized. In an example case, it should be obvious to a person of ordinary skill in the art that the procedure may be repeated for other stones, guided by the image of the stones as they appear in the overall scan image produced by the arrays.
[0030] In an example case, advantage is that embodiments of the present disclosure use resonant excitation of a selected region, through the intersecting focal region which could be as small as 1 mm3 and the difference frequency is tuned to the dominant resonant mode of vibration of the stone, the vibration being restricted to within the volume of intersection, defined by the region of interest 162. In an example case, since the burning or breaking of the inhomogeneity is based on matching the resonant frequency with the difference frequency of the acoustic wave, the region outside the intersection volume will remain unaffected and collateral damage to the healthy surrounding tissue is avoided. In an example case, the difference frequency can be tuned to match dominant resonant frequencies for different applications, where for clot mitigation in post-stroke recovery, the inhomogeneity, i.e., the clot, is a visco-elastic substance whose resonant frequencies will be much lower compared to a vibrating kidney stone. In an example case, the same is true with a malignant lesion, where the characteristic frequency may be quite different from both kidney stones and thrombi. In an example embodiment, dislodging of clots from coronary arteries may also fall under one of the very feasible applications of a tailored version of the same instrument to produce the correct resonant frequency.
[0031] In an example case, two linear-array transducers, consisting of many small elements, usually 1024 or 2048, may be fitted into a single line which forms a linear element. The linear arrays themselves may be fitted over mechanical rails, with precise independent movements ensured by two electronically driven piezo-based motion controllers. The rails meet or are designed to meet at right angles with adjustment to obtuse or acute angles as required. The motion has a resolution capability of 100 µm. The array which sections a transverse plane of the body deals with only that 2-D plane at a time. Different transverse planes may be scanned by moving the rails vertically using another rail on which the 2-D rail is mounted. The precision of the vertical movement may be preselected from 100µm upwards. The meeting point of the two rails, which chalk out a 2-D plane may be defined to be the part of the body under scan and may be the origin of coordinates for the cross-sectional image which position the inhomogeneities with assigned coordinates.
[0032] In an example case, controlling the ultrasound focal regions and their common intersection, scanning of a selected location in the 2-D cross-section of the body with this common area of intersection, control and automation of the entire data gathering process, image analysis of a localized region for pinpointing the inhomogeneities through computation of the relevant material properties may be done electronically and/or controlled by a computer. The system may have as its central part a microcontroller attached to a computer, a laptop. In an example case, some of the following major tasks come under the purview of the electronics and computational subsections of the Instrument.
1) Controlling the movements of the two linear arrays and reading out their positions in the control rail. In addition, it controls the movement of the dual array on its “vertical” axis (i.e., in a direction perpendicular to the plane being scanned) with its position continuously monitored and given as data to the main processing unit.
2) In addition, the linear transducers are operated in the usual ultrasound imaging mode and time-of-flight and intensity data are gathered for recovery of the transverse plane image using a callable Algorithm. Knowledge of inhomogeneity is greatly enhanced by recovering its visco-elasticity parameters from the nodal frequencies.
3) Moreover, the electronic system creates a curvature as desired on the plane wave emanating from the linear arrays. This is obtained by controlled firing of the individual array elements sequentially with time delay computed from the position of the common focal region desired and the average velocity of ultrasound in the intervening tissue.
[0033] The origin of the coordinate axes is first fixed at the mid-element of the linear array. A line parallel to the array is taken as the x-axis, and the one perpendicular to it the y-axis. A deep learning-based analysis of the 2-D plane in question helps us fix the stone cross-sections in this plane. One of them is selected for ultrasound-based concussion; as a first step, and to find the stiffness of the stone, the following preliminary experiment may be carried out.
[0034] First the ‘centre of mass’ of the region is computed. Following this, the linear array is moved so that the y-axis passes through the centre of mass. Starting with the elements at the centre, pairs of elements are fired in unison after time delays are computed from the local slope of the wavefront required for it to converge to the pre-selected point, i.e. the centre of mass of the stone. A receiver linear array detects the vibro-acoustic wave generated from the focal spot region through summing up of amplitudes pair wise and phase compensated by phased array detection. By scanning the frequency difference of the two ultrasound transducers in the approximate range where the resonant frequencies of the vibrating region is, one may ascertain the resonant modes of this small region. These resonant frequencies are used as data for the recovery of the visco-elasticity parameters of the material of the vibrating region. This verification confirms whether one is focusing the ultrasound beams within the inhomogeneity, the stone. The detection is with an acoustic transducer array. The electrical signals are further amplified using custom-made signal conditioning units and further processed through appropriate electronic modules. Fast recovery of mechanical properties is accomplished through deep learning-based inversion algorithms developed for processing.
[0035] The mechanical vibration in the focal region is governed by certain equations of motion (called the ‘mathematical model’ for the region) that reflect the conservation of momenta (i.e. the ‘physics information’). While the form of these equations is known, the parameter fields appearing therein (such as the elasticity moduli and the damping coefficient which together referred to as ‘the material properties’ of the region) are not known a-priori and must be determined based on the ‘frequency data’ available from ultrasound scanning. Moreover, for the ultrasound scalpel to work seamlessly alongside scanning, accurate determination of these material properties must happen in real time as the scanning goes on (and the location of the focal region accordingly changes). In order to achieve this end, physics-informed neural networks (PINNs) is used. Here, the network is pre-trained (i.e. the parameters of the network are pre-determined) by solving an optimization problem that puts high costs on large differences between frequencies determined from the ‘mathematical model’ of the vibrating focal region and those available from the ultrasound scanning. The aim of this optimization is to bring this cost as close to zero as possible and thus find the network parameters. When this training is done based on a set of fictitiously created (yet realistic) ‘data’, a pre-trained neural function is obtained that outputs the unknown coefficients in the mathematical model (i.e. the ‘material parameters’ of the focal region) given the data (i.e. the scanned frequency information). Once trained and validated, this trained neural function will output the material parameters given the ultrasound-detected natural frequencies within a tiny fraction of a second without the need to solve an optimization problem afresh. In other words, this will enable us to provide real-time graphical/quantitative outputs of the ‘material property’ distribution alongside scanning.
[0036] In an example case, a computing device with 64 GB RAM, 512 GB storage and with moderate computational power is the central processing unit. A microcontroller interface to the ultrasound arrays, both sources and detector, with software for the task at hand is provided. High-speed multi-channel data acquisition cards for handling data from the acoustic detectors form one section of the Electronic Assembly. Ultra-stable signal generators in tandem with power amplifiers provide the driving power signals to the source arrays. The inversion algorithms are developed and stored in the laptop which are callable through the main data gathering and recovery algorithm.
[0037] Soundwave have earlier been used to break kidney stones. In the earlier versions, electrical arcing was used to generate ‘multi-spectral’ acoustic waves directed towards the region where the stone is present. The wave produces heat through absorption in the general area around the stone. The rise in temperature in the region burns the stone as well as surrounding tissue. Bleeding owing to collateral damage is a side effect. As indicated in the previous section, in the novel version presented here, owing to the resonant excitation of the stone, high amplitude vibrations are set up at a lower intensity confined only to the stone. No collateral damage occurs. Electronic focusing allows precise focusing to address the stone wherever in the kidney it is located. At resonance, powdering occurs at lower intensities (less by 40%).
[0038] Although the present disclosure has been described with reference to several preferred embodiments, it should be understood that the present disclosure is not limited to the preferred embodiments disclosed here. Embodiments of the present disclosure are intended to cover various modifications and equivalent arrangements within the spirit and scope of the appended claims. Although the foregoing disclosure has been described in some detail for purposes of clarity of understanding, it will be apparent that certain changes and modifications may be practised within the scope of the appended claims. Examples of the present disclosure have been described in language specific to structural features and/or methods. It should be noted that there are many alternative ways of implementing both the process and apparatus of the present invention. Accordingly, embodiments of the present disclosure are to be considered illustrative and not restrictive, and the invention is not to be limited to the details given herein but may be modified within the scope and equivalents of the appended claims. It should be understood that the appended claims are not necessarily limited to the specific features or methods described. Rather, the specific features and methods are disclosed and explained as examples of the present disclosure. , Claims:We Claim:
1. A method for pulverizing a first object 165 located within a second object 160, the method comprising:
- detecting a resonant frequency (f0) associated with a first object 165, the first object 165 located within a second object 160;
- simultaneously driving the first object 165 at a first frequency f1 and at a second frequency f2;
- varying the second frequency f2 to create a difference frequency ?f, wherein the difference frequency ?f matches the resonant frequency (f0) associated with the first object 165;
- pulverizing the first object 165 by adjusting input Ultrasound power, wherein the object is pulverized when the first frequency ?f equals the resonant frequency f0 of the first object 165.

2. The method as claimed in claim 1, the method comprising:
- generating a first signal at a first frequency (f1) and a second signal at a second frequency (f2) wherein the first signal is generated at a source S1, and the second signal is generated at source S2;
- focusing the first signal and the second signal on the first object 165.

3. The method as claimed in claim 1, wherein the second frequency (f2) of the second signal is a sum of the first frequency (f1) of the first signal and the resonant frequency (f0) associated with the object 165.

4. The method as claimed in claim 1, wherein the first signal (f1) and the second signal (f2) produce beat frequencies, wherein the beat frequencies are produced by interferometric mixing of the first signal and the second signal in first object 165 within the second object 160.

5. The method as claimed in claim 4, wherein mixing of the first signal at frequency f1 and the second signal at frequency f2 produces waves with frequencies:
- a sum frequency ?f = f1 + f2; and
- a difference frequency ?f = f2-f1.

6. The method as claimed in claim 4, wherein the difference frequency ?f when equal to the resonant frequency f0 produces vibrations pulverizing only the first object 165 without affecting any surrounding regions in the second object 160.

7. The method as claimed in claim 1, wherein the first signal (f1) and the second signal (f2) are in the range of 1MHz to 7 MHz at the source.

8. The method as claimed in claim 1, wherein the difference frequency (?f) is restrained in the range of 50 Hz to about 100 kHz.

9. A system for generating difference frequency (?f ) sound wave, the system comprising:
- an ultra-stable digital function generator with a first channel (S1) configured to generate a first signal at a first frequency (f1), and a second channel (S2) configured to generate a second signal at a second frequency (f2), wherein the second frequency is a sum of the first frequency (f1) and the resonant frequency (f0) associated with the object 165;
- focusing the first signal and the second signal on a first object 165 located within a second object 160, generating an ultrasound wave with a difference frequency (?f), wherein the ultrasound wave with the difference frequency is associated with a resonant frequency (f0) of the object 165

10. The system as claimed in claim 9, wherein the difference frequency is configured to pulverize the first object 165 by adjusting input Ultrasound power, when the difference frequency ?f equals the resonant frequency f0 of the first object 165.

11. The system as claimed in claim 9, wherein the second frequency (f2) of the second signal is a sum of the first frequency (f1) of the first signal and the resonant frequency (f0) associated with the first object 165.

12. The system as claimed in claim 9, wherein the first signal (f1) and the second signal (f2) produce beat frequencies, wherein the beat frequencies are produced by interferometric mixing of the first signal and the second signal in first object 165 within the second object 160.

13. The system as claimed in claim 12, wherein mixing of the first signal at frequency f1 and the second signal at frequency f2 produces waves with frequencies:
- a sum frequency ?f = f1 + f2; and
- a difference frequency ?f = f2-f1.

14. The system as claimed in claim 13, wherein the difference frequency ?f when equal to the resonant frequency f0 produces vibrations pulverizing only the first object 165 without affecting any surrounding regions in the second object 160.

15. The system as claimed in claim 9, wherein the first signal (f1) and the second signal (f2) are in the range of 1MHz to 7 MHz at the source.

16. The system as claimed in claim 9, wherein the difference frequency (? f) is restrained in the range of 50 Hz to about 100 kHz.

Dated this 10th day of April 2024 Indian Institute of Science
By their Agent & Attorney

Dr. Eric W B Dias/Reg No 1058
of Khaitan & Co