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Title:
TRANSDUCER ASSEMBLY
Document Type and Number:
WIPO Patent Application WO/2019/186305
Kind Code:
A1
Abstract:
A transducer assembly for generating a multi-directional energy wavefront is disclosed, comprising: a transducer device configured to convert a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave; a first resonator device on one side of the transducer device; a parabolic reflector positioned to surround the transducer device and the first resonator device such that the transducer device and the first resonator device are at a focal point area of the parabolic reflector; and a grill having a secondary resonator plate towards its center to scatter the said energy wavefront.

Inventors:
TRICHUR, Ramchandran Shankarshastri (C5-404, Hyde Park Orchid CHS, Ghodbunder Road, Near Tulsidham, Maharashtra, Thane 0, 400610, IN)
Application Number:
IB2019/051926
Publication Date:
October 03, 2019
Filing Date:
March 09, 2019
Export Citation:
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Assignee:
RAMCHANDRAN, Shankar Trichur (E- 2/1204, Hyde Park Residency Ghodbunder Road, Near Hiranandani Meadows, Maharashtra, Thane 0, 400610, IN)
RAMCHANDRAN, Jaishree Trichur (C-5/404, Hyde Park Orchid CHS Ghodbunder Road, Near Tulsidham,,Maharashtra, Thane 0, 400610, IN)
IYER, Lakshmi (C-5/404 Hyde Park Orchid CHS, Ghodbunder Road Near Tulsidham, Maharashtra, Thane 0, 400610, IN)
International Classes:
H04R17/00; A61N7/00
Domestic Patent References:
WO2001050810A12001-07-12
Foreign References:
CN201667714U2010-12-08
US20140276055A12014-09-18
US20150092963A12015-04-02
Attorney, Agent or Firm:
KHURANA & KHURANA, ADVOCATES & IP ATTORNEYS (E-13, UPSIDC Site-IV, Behind-Grand Venice,Kasna Road, National Capital Region,,Uttar Pradesh, Greater Noida 0, 201310, IN)
Download PDF:
Claims:
We Claim:

1. A transducer assembly for generating an energy wavefront, the transducer assembly comprising:

a transducer device, wherein said transducer device is configured to convert a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave;

a first resonator device on one side of said transducer device;

a parabolic reflector, wherein said parabolic reflector is positioned surrounding said transducer device and said first resonator device such that said transducer device and said first resonator device are at a focal point area of said parabolic reflector; and

a grill having a secondary resonator plate towards its center.

2. The transducer assembly as claimed in claim 1, wherein said transducer device is any or a combination of a piezoelectric crystal positioned on a substrate such that said piezoelectric crystal has a dead zone towards its center and said combined ultrasonic and sonic wave that it creates has a hollow cylindrical shape, and a device that converts a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave having a hollow cylindrical shape.

3. The transducer assembly of claim 2, wherein said piezoelectric crystal comprises a metal substrate disc coupled with a crystal compound disc having a dead zone region at its center.

4. The transducer assembly as claimed in claim 1, wherein said first resonator device is a cavity resonator that comprises a hollow cylinder with one end placed on one side of said transducer device, and the other end having a first resonator plate.

5. The transducer assembly as claimed in claim 1, wherein said grill is positioned facing said parabolic reflector such that said secondary resonator plate is in front of other side of said transducer device.

6. The transducer assembly as claimed in claim 1, wherein:

a primary standing wave is created between said transducer device and said first resonator device, such that said primary standing wave is created due to interaction or resonance between said combined ultrasonic and sonic wave and a reflection of said combined ultrasonic and sonic wave from said first resonator device; a secondary standing wave is created between said transducer device and said secondary resonator plate such that said secondary standing wave is created due to interaction or resonance between said combined ultrasonic and sonic wave and a reflection of said combined ultrasonic and sonic wave from said secondary resonator plate; and

said parabolic reflector is configured to shape, reflect and transmit said energy wavefront such that said energy wavefront comprises wave elements of one or more of said combined ultrasonic and sonic wave, said primary standing wave, and said secondary standing wave.

7. The transducer assembly as claimed in claim 6, wherein said wave elements include one or more of the following:

parts of,

combinations of,

reflections of,

deflections of,

interferences of,

resonances of,

cross-talk between,

attenuations of, and

modifications of

one or more of said combined ultrasonic and sonic wave, said primary standing wave and said secondary standing wave.

8. The transducer assembly as claimed in claim 6, wherein said combined ultrasonic and sonic wave has a hollow cylindrical shape.

9. The transducer assembly of claim 6, wherein said secondary standing wave has constant peak with its amplitude at a point in space varying with time while its phase stays constant with respect to time.

10. The transducer assembly as claimed in claim 1, wherein there is variation in frequency of any or a combination of said sonic wave signal, said ultrasonic wave signal, and said combined ultrasonic and sonic waveform signal such that the variation in frequency is in an increasing sweep or a decreasing sweep or both.

11. The transducer assembly as claimed in claim 1, wherein said energy wavefront is in the form of a donut shaped toroidal wavefront.

12. The transducer assembly as claimed in claim 1, wherein said energy wavefront is scattered by said grill to make it multi-beam and multi-directional.

13. The transducer assembly as claimed in claim 1, wherein said combined ultrasonic and sonic waveform signal comprises of a sonic wave signal encapsulated in an ultrasonic wave signal or vice versa.

14. The transducer assembly of claim 1, wherein slicing angle and shape of said grill is adapted to scatter said energy wavefront to make it multi-beam and multi-directional.

15. The transducer assembly of claim 1, wherein said first resonator device compensates for resonant frequency tolerances of said transducer device.

16. The transducer assembly of claim 1, wherein said transducer device has a flat band response for all resonant frequencies.

17. The transducer assembly of claim 6, wherein the combination of said parabolic reflector and said grill is configured to perform any or a combination of:

slicing off said energy wavefront at appropriate angles,

modulating amplitude of said energy wavefront,

modulating amplitude of any of a combination of said primary standing wave and said secondary standing wave,

modulating parabolic spin angle of said energy wavefront, and blocking at least a portion of any or a combination of said energy wavefront, said primary standing wave and said secondary standing wave.

18. The transducer assembly of claim 1, wherein said parabolic reflector comprises a cavity surrounded by a tapered surface, the tapered surface bound by a taper angle of about 30 to 50 Degrees with a longitudinal surface of said parabolic reflector.

19. The transducer assembly of claim 1, wherein thickness of said grill ranges from about 1.5 mm to 4 mm, and wherein said grill has slots extending up to a thickness of about 3mm, and wherein said grill is in form of a disc of diameter from about 18.05 mm to 45 mm.

20. The transducer assembly of claim 1, wherein resonant ultrasonic frequency of said transducer device ranges between 20 kHz and 100 kHz, and resonant sonic frequency of said transducer device ranges between 1.5 Hz and 620 Hz.

21. The transducer assembly of claim 2, wherein said piezoelectric crystal comprises a metal substrate disc of diameter from about 27 mm to 40 mm that surrounds a crystal compound disc of diameter from about 20 mm to 30mm, said crystal compound disc in turn surrounding a dead zone region of diameter from about 6.5 mm to 15 mm, and wherein said metal substrate disc has a thickness from about 0.25 mm to about 0.5 mm.

22. The transducer assembly of claim 3, wherein diameter of said cavity resonator ranges from about 30 millimeter (mm) to about 40 mm, and is adjusted to change amplitude of said primary standing wave, and wherein height of said cavity resonator ranges from about 5 mm to about 9 mm, and is adjusted to modulate primary transmission beam angle of said combined ultrasonic and sonic wave.

23. The transducer assembly of claim 10, wherein said energy wavefront comprises a multi directional low frequency ultrasonic carrier sweep with an encapsulated multi-directional sonic frequency sweep having frequency ranges that cover natural resonant frequency range of human body as a whole as well as at cellular level.

24. The transducer assembly of claim 23, wherein said energy wavefront is configured to engulf a person from all directions, and wherein said energy wavefront creates a vibrational environment to stimulate cells of human body into a nascent state.

25. The transducer assembly of claim 23, wherein exposure of a person to said energy wavefront enables, for the person, any or a combination of:

stimulation of cell metabolism, targeted tissue repair, diabetic foot ulcer, Venus ulcer, organ re-vitalization and enhancement of drug delivery and efficiency, modification of cell membrane permeability leading to different rates of transports of ions and molecules across the cell membrane,

increase in potassium ion influx together with increase in sodium efflux, without inducing cell lysis or gross membrane damage, and

enhancement in intracellular concentration of calcium ions, tissue permeability, cell membrane permeability, calcium influx and release of insulin from pancreatic beta cells.

26. The transducer assembly of claim 23, wherein exposure of a person to said energy wavefront leads to, for the person, any or more of:

generation of micro bubbles in water and lipid bilayers of skin, improvement in the action potential of drugs,

improvement in glycemic control,

improvement in histological, pathological, biochemical and biomedical parameters of the person’s body,

inducement of remedial natural disease-free health, increase in vitamin D and calcium levels,

reduction in Alpha Glucosydase levels,

assistance in drug delivery of large molecule such as B6/B12 and absorption of the same,

effective regulation of Homocystein Metabolism, and

improvement in immunity profile.

Description:
TRANSDUCER ASSEMBLY

TECHNICAL FIELD

[0001] The present disclosure relates generally to generation and focusing of energy waves e.g., sonic waves and ultrasonic waves, and particularly to equipment for generating such waves for various purposes, including enhancing health.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Researches indicate that cells/organs/living organisms respond to internal as well as external surroundings. It has been observed that a slight change in pH levels within a cell can actuate a certain protein synthesis and can halt another for the same function. For example, a carcinogen is needed to trigger a change in behavior of a healthy cell and make the cell start expressing proteins which turn the cells cancerous. If an unhealthy change in environment can alter the state of a cell, then the converse should be true too. A healthy environment should trigger a healthy change.

[0004] Autonomic nervous system (ANS) in human beings is a control system that acts largely unconsciously and regulates bodily functions such as heart rate, digestion, respiratory rate, pupillary response, urination, and sexual arousal to name a few. Humans do not have much control over their heart rate or breathing. However, a soothing melody lowers our heart rate, hearing a loud explosion leads to higher heart palpitations. Such bodily functions are governed by the ANS through cells and organs present throughout body of a human being.

[0005] It has been envisaged that sound and vibrations bypass the conscious mind and have a direct effect on the ANS, thus, releasing regulatory hormones and enzymes and changing internal as well as external environment of various cells and organs. It is also a well-researched fact that every healthy living organism/cell resonates within a defined frequency range. Also, for unhealthy/sick cells the defined frequency range changes that leads to losing of desired vibrancy and vitality of the unhealthy/sick cells. Further, imposing external electromagnetic stimulation like radio waves disturbs vibrancy and vitality of healthy cells, impacts its resonance and eventually causing cell lysis, a medical condition that refers to the breaking down of membrane of a cell, often by viral, enzymic, or osmotic mechanisms that compromise integrity of the cell.

[0006] Ultrasound (ultrasonic) waves which are routinely used for diagnostic applications throughout the world are now being adopted in various fields of drug delivery systems and other therapeutic use. Acoustic interactions of ultrasound with biological tissues play an important role in biomedical applications of ultrasound. Low intensity ultrasonic is known to permeate the skin, modulate the cell membrane and alter its properties possibly activating signal transduction pathways. The energy absorbed by the enzymes from the ultrasonic effects the overall function of the cell.

[0007] Currently available transducer assemblies to stimulate cell metabolism are primarily based around a single resonant ultrasound frequency and do not provide for generation of variable amplitude/intensity nor wide -band multi— resonant frequency response.

[0008] Also, current contact methods of ultrasound/ultrasonic transmission to tissue rely on transmissive gels for maximum power transmission from transducer to tissue. Area of treatment is limited to transducer / applicator head area. Airborne ultrasound transmission is not only non-contact and non-invasive but treatment is more holistic and the area of treatment is not limited to just the transducer area. In fact, treatment is not limited to single patient, multiple persons having same ailment can receive airborne ultrasound from same device.

[0009] There is therefore a need in the art to provide a transducer assembly capable of generating, shaping and scattering energy waves including any or a combination of ultrasonic waves and sonic waves to obtain airborne, non-contact, variable-intensity, multi-frequency, multi-beam and multi-directional energy waves capable of generating ultrasonic vibrations.

[0010] As used in the description herein and throughout the claims that follow, the meaning of“a,”“an,” and“the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of“in” includes“in” and“on” unless the context clearly dictates otherwise.

[0011] In some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0012] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g.“such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0013] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

OBJECTS OF THE INVENTION

[0014] A general object of the present disclosure is to provide a transducer assembly that generates non-contact, variable-intensity, multi-frequency, multi-beam and multi-directional energy waves comprising any or a combination of ultrasonic waves and sonic waves.

[0015] Another object of the present disclosure is to provide a transducer assembly that generates energy waves having multiple resonant frequencies spanning over various sonic and ultrasonic ranges, to have a wide band response to target different diseases and organs with specific frequency and intensity.

[0016] Another object of the present disclosure is to provide a transducer assembly that effectively shapes a wavefront to obtain multi-beam and multi-directional energy wavefront with variable amplitude/intensity. [0017] Still another object of the present disclosure is to provide a transducer assembly that creates a vibrational environment to stimulate cells of human body into a nascent state using the energy waves generated thereof.

SUMMARY

[0018] The present disclosure provides a transducer assembly, useful in medical treatments, such as but not limited to, stimulation of cell metabolism, and other non-medical uses, such as but not limited to, non-destructive testing of structures, to generate, shape and scatter ultrasonic waves encapsulating sonic waves.

[0019] In an aspect, present disclosure elaborates upon a transducer assembly for generating an energy wavefront. The transducer assembly can include: a transducer device, wherein the transducer device can be configured to convert a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave; a first resonator device on one side of the transducer device; a parabolic reflector, wherein the parabolic reflector can be positioned surrounding the transducer device and the first resonator device such that the transducer device and the first resonator device are at a focal point area of the parabolic reflector; and a grill having a secondary resonator plate towards its center.

[0020] In another aspect, the transducer device can be any or a combination of a piezoelectric crystal positioned on a substrate such that the piezoelectric crystal has a dead zone towards its center and the combined ultrasonic and sonic wave that it creates has a hollow cylindrical shape, and a device that converts a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave having a hollow cylindrical shape.

[0021] In yet another aspect, the piezoelectric crystal can include a metal substrate disc coupled with a crystal compound disc having a dead zone region at its center.

[0022] In an aspect, the first resonator device can be a cavity resonator that can include a hollow cylinder with one end placed on one side of the transducer device, and the other end can have a first resonator plate.

[0023] In another aspect, the grill can be positioned facing the parabolic reflector such that the secondary resonator plate can be in front of other side of the transducer device.

[0024] In yet another aspect, a primary standing wave can be created between the transducer device and the first resonator device, such that the primary standing wave can be created due to interaction or resonance between the combined ultrasonic and sonic wave and a reflection of the combined ultrasonic and sonic wave from the first resonator device; a secondary standing wave can be created between the transducer device and the secondary resonator plate such that the secondary standing wave can be created due to interaction or resonance between the combined ultrasonic and sonic wave and a reflection of the combined ultrasonic and sonic wave from the secondary resonator plate; and the parabolic reflector can be configured to shape, reflect and transmit the energy wavefront such that the energy wavefront can include wave elements of one or more of the combined ultrasonic and sonic wave, the primary standing wave, and the secondary standing wave.

[0025] In an aspect, the wave elements include one or more of the following: parts of, combinations of, reflections of, deflections of, interferences of, resonances of, cross-talk between, attenuations of, and modifications of one or more of the combined ultrasonic and sonic wave, the primary standing wave and the secondary standing wave.

[0026] In another aspect, the combined ultrasonic and sonic wave can have a hollow cylindrical shape.

[0027] In yet another aspect, the secondary standing wave can have constant peak with its amplitude at a point in space varying with time while its phase can stay constant with respect to time.

[0028] In an aspect, there can be variation in frequency of any or a combination of the sonic wave signal, the ultrasonic wave signal, and the combined ultrasonic and sonic waveform signal such that the variation in frequency can be in an increasing sweep or a decreasing sweep or both.

[0029] In another aspect, the energy wavefront can be in the form of a donut shaped toroidal wavefront.

[0030] In yet another aspect, the energy wavefront can be scattered by the grill to make it multi-beam and multi-directional.

[0031] In an aspect, the combined ultrasonic and sonic waveform signal can include a sonic wave signal encapsulated in an ultrasonic wave signal or vice versa.

[0032] In another aspect, slicing angle and shape of the grill can be adapted to scatter the energy wavefront to make it multi-beam and multi-directional.

[0033] In yet another aspect, the first resonator device can compensate for resonant frequency tolerances of the transducer device.

[0034] In an aspect, the transducer device can have a flat band response for all resonant frequencies. [0035] In another aspect, the combination of the parabolic reflector and the grill can be configured to perform any or a combination of: slicing off the energy wavefront at appropriate angles, modulating amplitude of the energy wavefront, modulating amplitude of any of a combination of the primary standing wave and the secondary standing wave, modulating parabolic spin angle of the energy wavefront, and blocking at least a portion of any or a combination of the energy wavefront, the primary standing wave and the secondary standing wave.

[0036] In an aspect, the parabolic reflector can include a cavity surrounded by a tapered surface, the tapered surface bound by a taper angle of about 30 to 50 Degrees with a longitudinal surface of the parabolic reflector.

[0037] In another aspect, thickness of the grill can range from about 1.5 mm to 4 mm, and the grill can have slots extending up to a thickness of about 3mm, and the grill can be in form of a disc of diameter from about 18.05 mm to 45 mm.

[0038] In yet another aspect, resonant ultrasonic frequency of the transducer device can range between 20 kHz and 100 kHz, and resonant sonic frequency of the transducer device can range between 1.5 Hz and 620 Hz.

[0039] In an aspect, the piezoelectric crystal can include a metal substrate disc of diameter from about 27 mm to 40 mm that surrounds a crystal compound disc of diameter from about 20 mm to 30mm, the crystal compound disc in turn surrounding a dead zone region of diameter from about 6.5 mm to 15 mm, and the metal substrate disc can have a thickness from about 0.25 mm to about 0.5 mm.

[0040] In another aspect, diameter of the cavity resonator can range from about 30 millimeter (mm) to about 40 mm, and can be adjusted to change amplitude of the primary standing wave, and height of the cavity resonator can range from about 5 mm to about 9 mm, and can be adjusted to modulate primary transmission beam angle of the combined ultrasonic and sonic wave.

[0041] In yet another aspect, the energy wavefront can include a multi-directional low frequency ultrasonic carrier sweep with an encapsulated multi-directional sonic frequency sweep having frequency ranges that cover natural resonant frequency range of human body as a whole as well as at cellular level.

[0042] In an aspect, the energy wavefront can be configured to engulf a person from all directions, and can creates a vibrational environment to stimulate cells of human body into a nascent state. [0043] In another aspect, exposure of a person to the energy wavefront can enable, for the person, any or a combination of: stimulation of cell metabolism, targeted tissue repair, diabetic foot ulcer, Venus ulcer, organ re-vitalization and enhancement of drug delivery and efficiency, modification of cell membrane permeability leading to different rates of transports of ions and molecules across the cell membrane; increase in potassium ion influx together with increase in sodium efflux, without inducing cell lysis or gross membrane damage, and enhancement in intracellular concentration of calcium ions, tissue permeability, cell membrane permeability, calcium influx and release of insulin from pancreatic beta cells.

[0044] In yet another aspect, exposure of a person to the energy wavefront can lead to, for the person, any or more of: generation of micro bubbles in water and lipid bilayers of skin, improvement in the action potential of drugs, improvement in glycemic control, improvement in histological, pathological, biochemical and biomedical parameters of the person’s body, inducement of remedial natural disease-free health, increase in vitamin D and calcium levels, reduction in Alpha Glucosydase levels, assistance in drug delivery of large molecule such as B6/B12 and absorption of the same, effective regulation of Homocystein Metabolism, and improvement in immunity profile.

[0045] Those skilled in the art will further appreciate the advantages and superior features of the disclosure together with other important aspects thereof on reading the detailed description that follows in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0047] FIG. 1 illustrates an exemplary exploded view of the proposed transducer assembly in accordance with an exemplary embodiment of the present disclosure.

[0048] FIG. 2 illustrates an exemplary representation of the proposed transducer assembly emitting donut shaped/toroidal energy wavefront in accordance with an exemplary embodiment of the present disclosure.

[0049] FIGs.3A through 3C illustrate exemplary representations of a cavity resonator of proposed transducer assembly in accordance with an exemplar embodiment of the present disclosure. [0050] FIGs.4A through 4C illustrate exemplary representations of a piezoelectric crystal of the proposed transducer assembly in accordance with an exemplary embodiment of the present disclosure.

[0051] FIGs.5A through 5C illustrate exemplary representations of a parabolic reflector of the proposed transducer assembly in accordance with an exemplary embodiment of the present disclosure.

[0052] FIGs.6A through 6C illustrate exemplary representations of a wave slicer grill of the proposed transducer assembly in accordance with an exemplary embodiment of the present disclosure.

[0053] FIG. 7 illustrates an exemplary representation of the donut shaped/toroidal energy wavefront emitted from the transducer assembly in accordance with an exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION

[0054] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such details as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0055] If the specification states a component or feature“may”,“can”,“could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0056] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This disclosure may however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those of ordinary skill in the art. Moreover, all statements herein reciting embodiments of the disclosure, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). [0057] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0058] Embodiment explained herein relates to a transducer assembly capable of generating, shaping and scattering ultrasonic waves encapsulating sonic waves in order to generate ultrasonic vibrations useful in various medical as well as non-medical applications.

[0059] In an aspect, present disclosure elaborates upon a transducer assembly for generating an energy wavefront. The transducer assembly can include: a transducer device, wherein the transducer device can be configured to convert a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave; a first resonator device on one side of the transducer device; a parabolic reflector, wherein the parabolic reflector can be positioned surrounding the transducer device and the first resonator device such that the transducer device and the first resonator device are at a focal point area of the parabolic reflector; and a grill having a secondary resonator plate towards its center.

[0060] In another aspect, the transducer device can be any or a combination of a piezoelectric crystal positioned on a substrate such that the piezoelectric crystal has a dead zone towards its center and the combined ultrasonic and sonic wave that it creates has a hollow cylindrical shape, and a device that converts a combined ultrasonic and sonic waveform signal into a combined ultrasonic and sonic wave having a hollow cylindrical shape.

[0061] In yet another aspect, the piezoelectric crystal can include a metal substrate disc coupled with a crystal compound disc having a dead zone region at its center.

[0062] In an aspect, the first resonator device can be a cavity resonator that can include a hollow cylinder with one end placed on one side of the transducer device, and the other end can have a first resonator plate.

[0063] In another aspect, the grill can be positioned facing the parabolic reflector such that the secondary resonator plate can be in front of other side of the transducer device.

[0064] In yet another aspect, a primary standing wave can be created between the transducer device and the first resonator device, such that the primary standing wave can be created due to interaction or resonance between the combined ultrasonic and sonic wave and a reflection of the combined ultrasonic and sonic wave from the first resonator device; a secondary standing wave can be created between the transducer device and the secondary resonator plate such that the secondary standing wave can be created due to interaction or resonance between the combined ultrasonic and sonic wave and a reflection of the combined ultrasonic and sonic wave from the secondary resonator plate; and the parabolic reflector can be configured to shape, reflect and transmit the energy wavefront such that the energy wavefront can include wave elements of one or more of the combined ultrasonic and sonic wave, the primary standing wave, and the secondary standing wave.

[0065] In an aspect, the wave elements include one or more of the following: parts of, combinations of, reflections of, deflections of, interferences of, resonances of, cross-talk between, attenuations of, and modifications of one or more of the combined ultrasonic and sonic wave, the primary standing wave and the secondary standing wave.

[0066] In another aspect, the combined ultrasonic and sonic wave can have a hollow cylindrical shape.

[0067] In yet another aspect, the secondary standing wave can have constant peak with its amplitude at a point in space varying with time while its phase can stay constant with respect to time.

[0068] In an aspect, there can be variation in frequency of any or a combination of the sonic wave signal, the ultrasonic wave signal, and the combined ultrasonic and sonic waveform signal such that the variation in frequency can be in an increasing sweep or a decreasing sweep or both.

[0069] In another aspect, the energy wavefront can be in the form of a donut shaped toroidal wavefront.

[0070] In yet another aspect, the energy wavefront can be scattered by the grill to make it multi-beam and multi-directional.

[0071] In an aspect, the combined ultrasonic and sonic waveform signal can include a sonic wave signal encapsulated in an ultrasonic wave signal or vice versa.

[0072] In another aspect, slicing angle and shape of the grill can be adapted to scatter the energy wavefront to make it multi-beam and multi-directional.

[0073] In yet another aspect, the first resonator device can compensate for resonant frequency tolerances of the transducer device.

[0074] In an aspect, the transducer device can have a flat band response for all resonant frequencies.

[0075] In another aspect, the combination of the parabolic reflector and the grill can be configured to perform any or a combination of: slicing off the energy wavefront at appropriate angles, modulating amplitude of the energy wavefront, modulating amplitude of any of a combination of the primary standing wave and the secondary standing wave, modulating parabolic spin angle of the energy wavefront, and blocking at least a portion of any or a combination of the energy wavefront, the primary standing wave and the secondary standing wave.

[0076] In an aspect, the parabolic reflector can include a cavity surrounded by a tapered surface, the tapered surface bound by a taper angle of about 30 to 50 Degrees with a longitudinal surface of the parabolic reflector.

[0077] In another aspect, thickness of the grill can range from about 1.5 mm to 4 mm, and the grill can have slots extending up to a thickness of about 3mm, and the grill can be in form of a disc of diameter from about 18.05 mm to 45 mm.

[0078] In yet another aspect, resonant ultrasonic frequency of the transducer device can range between 20 kHz and 100 kHz, and resonant sonic frequency of the transducer device can range between 1.5 Hz and 620 Hz.

[0079] In an aspect, the piezoelectric crystal can include a metal substrate disc of diameter from about 27 mm to 40 mm that surrounds a crystal compound disc of diameter from about 20 mm to 30mm, the crystal compound disc in turn surrounding a dead zone region of diameter from about 6.5 mm to 15 mm, and the metal substrate disc can have a thickness from about 0.25 mm to about 0.5 mm.

[0080] In another aspect, diameter of the cavity resonator can range from about 30 millimeter (mm) to about 40 mm, and can be adjusted to change amplitude of the primary standing wave, and height of the cavity resonator can range from about 5 mm to about 9 mm, and can be adjusted to modulate primary transmission beam angle of the combined ultrasonic and sonic wave.

[0081] In yet another aspect, the energy wavefront can include a multi-directional low frequency ultrasonic carrier sweep with an encapsulated multi-directional sonic frequency sweep having frequency ranges that cover natural resonant frequency range of human body as a whole as well as at cellular level.

[0082] In an aspect, the energy wavefront can be configured to engulf a person from all directions, and can creates a vibrational environment to stimulate cells of human body into a nascent state.

[0083] In another aspect, exposure of a person to the energy wavefront can enable, for the person, any or a combination of: stimulation of cell metabolism, targeted tissue repair, diabetic foot ulcer, Venus ulcer, organ re-vitalization and enhancement of drug delivery and efficiency, modification of cell membrane permeability leading to different rates of transports of ions and molecules across the cell membrane; increase in potassium ion influx together with increase in sodium efflux, without inducing cell lysis or gross membrane damage, and enhancement in intracellular concentration of calcium ions, tissue permeability, cell membrane permeability, calcium influx and release of insulin from pancreatic beta cells.

[0084] In yet another aspect, exposure of a person to the energy wavefront can lead to, for the person, any or more of: generation of micro bubbles in water and lipid bilayers of skin, improvement in the action potential of drugs, improvement in glycemic control, improvement in histological, pathological, biochemical and biomedical parameters of the person’s body, inducement of remedial natural disease-free health, increase in vitamin D and calcium levels, reduction in Alpha Glucosydase levels, assistance in drug delivery of large molecule such as B6/B12 and absorption of the same, effective regulation of Homocystein Metabolism, and improvement in immunity profile.

[0085] An aspect of the present disclosure pertains to a transducer assembly that includes a piezoelectric crystal that includes a metal substrate disc coupled with a crystal compound disc having a dead zone region at its center, said piezoelectric crystal capable of generating a primary wavefront having a hollowed cylinder shape, wherein the piezoelectric crystal has a flat band response for all the resonant frequencies, and wherein the primary wavefront generated thereof includes low frequency ultrasonic waves with encapsulated sonic waves, and a secondary wave shaping and scattering unit that includes a parabolic reflector to shape the primary wavefront and a wave slicer grill to scatter the primary wavefront in order to obtain an airborne, variable-intensity, multi-frequency, multi-beam and multi-directional energy wavefront that includes sonic waves encapsulated by ultrasonic waves, wherein slicing angle and shape of the wave slicer grill is adapted to scatter the energy wavefront to obtain a defined number of beams having specific beam intensities to be emitted from the transducer assembly, and wherein the energy wavefront has a donut shaped/toroidal wavefront.

[0086] FIG. 1 illustrates an exemplary exploded view of the proposed transducer assembly in accordance with an exemplary embodiment of the present disclosure. In an embodiment, the transducer assembly 100 can include a cavity resonator 102 to shape the primary wavefront in order to obtain multi frequency sweeping primary standing waves. In an embodiment, the transducer assembly 100 can include a secondary wave shaping and scattering unit that can attenuate and shape the primary standing waves to obtain a secondary wavefront. In an embodiment, the secondary wave shaping and scattering unit can include a wave slicer grill (illustrated as 108) that can scatter the secondary wavefront so as to block at least a portion of the secondary wavefront into multi-direction secondary standing waves and to allow emission of the secondary wavefront that are in the form of the donut shaped/toroidal energy wavefront 202 (as shown in FIG. 2). In an embodiment, the wave slicer grill 108 can slice the energy wavefront at appropriate grill angles.

[0087] In an aspect, the transducer assembly 100 can include a cavity resonator 102 to shape the primary wavefront in order to obtain multi frequency sweeping primary standing waves, piezoelectric crystal 104 to generate the primary wavefront that includes low frequency ultrasonic waves with encapsulated sonic waves, a parabolic reflector 106 to shape the primary wavefront generated by the piezoelectric crystal 104, said cavity resonator 102 and piezoelectric crystal 104 arranged at a location in vicinity of focal area of the parabolic reflector 106 to allow modulation of transmission beam angle of the primary wavefront beams by adjusting focal length of the parabolic reflector 106. The transducer assembly 100 can further include a wave slicer grill 108 that can be coupled with at least one resonator plate ( shown as 604 in FIG. 6) to generate secondary standing waves and a secondary/energy wavefront that can be in the form of donut shaped/toroidal energy waveform and can be emitted from the wave slicer grill 108 so as to create ultrasonic vibrations useful in medical as well as non-medical applications, such as, for stimulation of cell metabolism, for non-destructive testing of various materials to name a few.

[0088] A sweeping wave as described herein means a wave/ wavefront the frequency of which varies (or sweeps) over a pre-determined range.

[0089] In an embodiment, combination of the parabolic reflector 106 and the wave slicer grill 108 can be construed as a secondary wave shaping and scattering unit capable of generating secondary standing waves and further capable of scattering the secondary wavefront comprising sonic waves encapsulated by ultrasonic waves to enable generation of ultrasonic vibrations.

[0090] Referring now to FIG. 2, the transducer assembly 100 can emit the multi-beam and multi-direction donut shaped/toroidal energy wavefront 202 that includes multi directional low frequency ultrasonic carrier sweep with an encapsulated multi-directional sonic frequency sweep having frequency range that cover natural resonant frequency range of human body as a whole as well as at cellular level in order to effective stimulate and/or modulate cell metabolism of the human body.

[0091] It would be appreciated that the energy wavefront generated by the proposed piezoelectric crystall04 can be used for medical as well as non-medical applications, for example, for non-destructive testing of various materials that utilizes energy waves, such as ultrasonic waves and sonic waves, to detect defects and/or anomalies in the materials.

[0092] FIGs.3A through 3C illustrate perspective view, front view and a sectional view of section A-A of the cavity resonator 102 of proposed transducer assembly respectively in accordance with an exemplary embodiment of the present disclosure. In an embodiment, the cavity resonator 102 can shape the primary wavefront in order to obtain multi frequency sweeping primary standing waves. The primary standing waves are formed by interference of at least two waves of identical frequency with one another while travelling in opposite directions along the same medium. In an embodiment, the cavity resonator 102 can generate multi frequency sweeping primary standing waves by shaping/tuning at least a portion of the primary wavefront. In an embodiment, the primary wavefront generated by the piezoelectric crystal traverses through the cavity resonator 102 and when waves emitted by the piezoelectric crystal and waves reflected by the cavity resonator 102 intersect, primary standing waves are formed.

[0093] In an embodiment, the cavity resonator 102 can have a plurality of slots 302 to allow electrical connection of the piezoelectric crystal with a waveform/wave pattern/wave signal generating device with the help of wires traversing through the slots 102.

[0094] In an embodiment, the cavity resonator 102 can tune and lock in dynamic sweep frequencies of the primary wavefront resulting in the multi frequency sweeping primary standing waves. A piezoelectric crystall04 (as shown in detail in FIG. 4A) can be coupled to one end of the cavity resonator 102, thereby making the cavity resonator 102 a hollow cylinder with both ends capped.

[0095] In an embodiment, diameter of the cavity resonator 102 can range between 30 mm and 40 mm. Amplitude of the resulting primary standing waves can be modulated by changing diameter of the cavity resonator 102. In an embodiment, height of the cavity resonator 102 can range between 5 mm and 9 mm, which can be adjusted to modulate primary transmission beam angle of the primary wavefront. The cavity resonator 102 can compensate for any tolerances of resonant frequency of the piezoelectric crystal 104. [0096] FIGs.4A through 4C illustrate exemplary perspective view, rear view and a sectional view of section B-B of the piezoelectric crystal of the proposed transducer assembly respectively in accordance with an exemplary embodiment of the present disclosure. In an aspect, the piezoelectric crystal 104 includes a metal substrate disc402 arranged concentrically with a crystal compound disc 404 that contains a crystal elements, such as, quartz, Rochelle salt and other ceramic as well as non-ceramic materials. The crystal compound disc 404 includes a dead zone region406 at its center for creating toroidal wavefronts. The metal substrate disc 402 can be coupled with the crystal compound disc 404 by a fastening technique, such as, adhesion, welding, fitting and the likes.

[0097] In an aspect, the dead zone region406 assists the piezoelectric crystal 104 to generate the primary wavefront that includes low frequency ultrasonic waves with encapsulated sonic waves. In an embodiment, resonant sonic frequency of the piezoelectric crystall04 can range between 20 kHz to 200 kHz. In an embodiment, resonant ultrasonic frequency of the piezoelectric crystall04 can range between 1.5 Hz to 20 kHz.

[0098] In an embodiment, shape of the crystal compound disc 404 assists in generation of a plane ultrasonic wave. However, it would be appreciated that crystal compound disc of a different shape such as a crystal disc having a curve on its radiating surface can be used to generate a slightly concave or bowl shape ultrasonic wave that can focus/converge at a specific point.

[0099] In an embodiment, the piezoelectric crystal 104 covers a broad coverage of the over defined sonic and ultrasonic ranges. In an embodiment, the piezoelectric crystal 104 has a flat band response for all the resonant frequencies.

[00100] In an embodiment, the primary wavefront after being shaped by the cavity resonator 102 passes to a secondary wave shaping and scattering unit. In an embodiment, the cavity resonator 102 can compensate for resonant frequency tolerances of the piezoelectric crystal 104.

[00101] In an embodiment, resonant ultrasonic frequency of the piezoelectric crystal 104 can range between 20 kHz and 100 kHz. In an embodiment, resonant sonic frequency of the piezoelectric crystall04 can range between 1.5 Hz and 620 Hz.

[00102] In an embodiment, the metal substrate disc 402 can be arranged concentrically with the crystal compound disc 404.

[00103] In an embodiment, diameter of the metal substrate disc 402 can range between 27 mm and 40 mm. In an embodiment, diameter of the crystal compound disc 404 can range between 20 mm and 30 mm. In an embodiment, diameter of the dead zone region406 can range between 3.5 mm and 6 mm. In an embodiment, thickness of the metal substrate disc 402 can range between 0.25 mm and 0.5 mm.

[00104] In an embodiment, the piezoelectric crystal404 is formulated/structured so as to obtain a wide band piezoelectric crystal capable of generating multi-frequency resonant waves such that the resonant waves encompass multiple desired frequencies. Special doping techniques are implemented and various compounds in correct proportions are used in formulation of the proposed piezoelectric crystal404. In a way, the multi resonant piezoelectric crystal404 is a combination of many single frequency crystals into one.

[00105] Referring now to FIGs.5A through 5C, where exemplary perspective view, front view and a sectional view of section C-C of the parabolic reflector is shown respectively, the parabolic reflector 106 can include a cavity 502 surrounded by a tapered surface 504. The tapered surface 504 can be bound by a taper angle of 111.49° with a longitudinal surface of the parabolic reflector 106. In an embodiment, the parabolic reflector 106 can shape the primary wavefront generated by the piezo crystal l04arranged at a location in vicinity of focal area of the parabolic reflector 106. In an embodiment, the parabolic reflector 106 can assist in modulation of transmission beam angle of the primary wavefront beams by adjusting focal length of the parabolic reflector 106.

[00106] In an embodiment, the primary wavefront can be in the form of donut shaped/toroidal waves generated by the piezoelectric crystal 104 that is coupled to a focal area of the parabolic reflector 106.

[00107] FIGs.6A through 6C illustrate exemplary perspective view, front view and rear view of thewave slicer grill of the proposed transducer assembly respectively in accordance with an exemplary embodiment of the present disclosure. In an aspect, the wave slicer grill 108 can include a plurality of slots 602 to segregate the primary wavefront shaped by the parabolic reflector 106 into a plurality of beams as to obtain multi -beam energy wavefront as output of the wave slicer grill 108. In an embodiment, the plurality of slots 602 further direct the plurality of beams of the primary wavefront into multiple directions to obtain multi directional energy wavefront as output of the wave slicer grill 108.

[00108] In an embodiment, the wave slicer grill 108 can be coupled with at least one resonator plate 604 to generate secondary standing waves having constant peaks with amplitude of such standing waves at a point in space varying with time, but their phase staying constant with respect to time. In an embodiment, the at least one resonator plate 604 can assist in attenuation of the primary wavefront and lateral traverse length of the secondary standing waves prior to emission of the energy waves through the wave slicer grill 108. In an embodiment, attenuation of the primary wavefront and lateral traverse length of the secondary standing waves are dependent on diameter and shape of the at least one resonator plate 604 and can be modulated by changing any or a combination of the diameter and shape of the at least one resonator plate 604.

[00109] In an embodiment, the primary standing waves are generated as a result of interaction of the emitted waves and reflected waves between a cavity resonator and the piezoelectric crystal 104. The piezoelectric crystal 104 is the primary source emitting the primary wavefront that are tuned inside the cavity resonant to generate the primary standing waves. The primary standing waves as they traverse through the parabolic reflector 106 and the wave slicer grill 108 create secondary standing waves. This interaction and cross talk produces a toroidal/donut shaped wavefront which is sliced at appropriate angles at the wave slicer grill 108, thereby generating a multi-directional energy wavefront capable of engulfing a subject being treated by the wave generating device from all directions.

[00110] In an embodiment, the parabolic reflector 106 and the wave slicer grill 108 can be construed as the secondary wave shaping and scattering unit that can be configured to modulate parabolic spin angle of the energy wavefront, to block at least a portion of any of the energy wavefront, the primary standing waves and the secondary standing waves , to modulate amplitude of the energy wavefront, and to slice the energy wavefront at appropriate grill angles so as to obtain the donut shaped/toroidal multi-beam and multi-directional energy waveform as output of the secondary wave shaping and scattering unit.

[00111] In an embodiment, thickness of the wave slicer grill 108 can range between 0.5 mm and 6.5 mm with the plurality of slots 602 extending up to a thickness of 3 mm of the wave slicer grill 108.

[00112] In an embodiment, the wave slicer grill 108 can be in the form of a disc with diameter of the wave slicer grill 108 ranging between 30 mm and 72 mm.

[00113] FIG. 7 illustrates an exemplary representation of the donut shaped/toroidal energy wavefront emitted from the transducer assembly in accordance with an exemplary embodiment of the present disclosure. In an aspect, the donut shaped/toroidal energy wavefront202 includes multi-directional low frequency ultrasonic carrier sweep with an encapsulated multi-directional sonic frequency sweep. The sonic waves are encapsulated with the ultrasonic waves such that frequency ranges of the ultrasonic waves and the encapsulated sonic waves can confer with the natural resonant frequency of human body as a whole as well as at cellular level in order to effective stimulate and/or module cell metabolism of the human body with the help of the ultrasonic vibrations generated thereof.

[00114] In an embodiment, the transducer assembly 100 can be configured to modulate parabolic spin angle of the energy wavefront. In an embodiment, the wave shaping and scattering unit can further be configured to modulate parabolic spin angle of the energy wavefront, to block at least a portion of any of the energy wavefront, the primary standing waves and the secondary standing waves , to modulate amplitude of the energy wavefront, and to slice the energy wavefront at appropriate grill angles so as to obtain the donut shaped/toroidal multi-beam and multi-directional energy waveform as output of the secondary wave shaping and scattering unit.

[00115] In an embodiment, sonic waves are beneficial in stimulating bodily functions at organ and cell level. However, use of sonic waves in medical applications is confined as they do not have the ability to penetrate deep tissue. On the contrary, low intensity and low frequency ultrasonic waves have deeper penetration than sonic waves. Hence, encapsulation of sonic waves with ultrasonic carrier allows the sonic waves to piggy back on the ultrasonic carrier. In addition, the ultrasonic carrier also assists in cellular/organ revitalization to enhance operational capability of the medical application, for example, engulfing a subject being treated with the generated toroidal/donut shaped energy waves from all directions.

[00116] In an embodiment, the proposed transducer assembly 100 can allow generation of a non-contact, non-invasive, airborne, toroidal shaped, encapsulated energy wavefront having sonic waves encapsulated by ultrasonic waves, useful in medical treatments, such as but not limited to, stimulation of cell metabolism, targeted tissue repair (Diabetic foot ulcer and Venus ulcer and all other types wounds) and organ re-vitalization, enhancing drug delivery and efficiency, and other non-medical uses, such as but not limited to, non-destructive testing of structures.

[00117] In an embodiment, mechanical effects of the proposed transducer assembly 100 can modify cell membrane permeability leading to different rates of transports of ions and molecules across the cell membrane. Exposure to the proposed transducer assembly 100 can lead to increase in potassium ion influx together with increase in sodium efflux, without inducing cell lysis or gross membrane damage. An increase in the intracellular concentration of calcium ions can be seen to occur after exposure to the proposed transducer assembly 100. Further, the proposed transducer assembly 500 works on the Thermal and Non-Thermal principles of Ultrasonic physics known as Cavitations, Acoustic Streaming, Microbubbles, Sonoporation, and Sonophoresis and are the possible mechanism for enhanced tissue permeability. The proposed transducer assembly 500 effects help enhances calcium influx and the release of insulin from pancreatic beta cells.

[00118] In an embodiment, the proposed transducer assembly 100 can generate microbubbles in water and lipid bilayers of the skin and can increase permeability of cell membrane to drugs delivered by the process of acoustic streaming and sonophoresis through mechano transduction.

[00119] In an embodiment, the proposed transducer assembly 100 can improve the action potential of drugs, and further improves glycemic control. Therapeutic use of airborne ultrasonic generated by the proposed transducer assembly 100 induce, improvise, regain, rebuild, repair, alter and treat diseased human immunological system there by improving histological, pathological, biochemical and biomedical parameters of diseased human body and also induce remedial natural disease-free health. The proposed transducer assembly 100 also helps in increasing Vitamin D and calcium levels in patients, thus, reducing Alpha Glucosydase levels.

[00120] In an embodiment, the proposed transducer assembly 100 is very effective in treatment of Diabetic foot ulcer, Venus ulcer and all other types of wounds. The proposed transducer assembly 100 is useful for drug delivery of large molecule such as B6/B12 and absorption of the same. Also, the proposed transducer assembly 100 is useful for better management of diabetes and associated vascular and cardio vascular complications. It has potential in preventing the future onset on diabetic nephropathy, neuropathy, retinopathy and other associated complications because of poor glycemic control.

[00121] In an embodiment, due to proper management of Diabetes, Homocystien Metabolism can be regulated effectively, Vitamin D and calcium Metabolism can be regulated effectively and immune profile of a subject can be improved. When Vitamin B6/B12 absorption is increased overall reduction in inflammation in the body comes down. Hence absorption of calcium and vitamin D is increased. This results in reduced resistance to Peripheral insulin, reduction in alpha and beta cell dysfunction, and increases in insulin production. Better glycemic control by using the proposed transducer assembly 100 improves reduction and reversal of neuro and muscular degeneration in the body.

[00122] It would be appreciated that the proposed transducer assembly 100 is a better remedial measure for the management of diabetes and associated vascular complications and cardio vascular complications. It has potential in preventing the future onset on diabetic nephropathy, neuropathy, retinopathy and other associated complications because of better glycemic control. The exposure with the proposed transducer assembly 100 after a specific duration of meals may have action in decreasing the body weight gain and anti- hyperglycemic episodes. The reduction in body inflammations indicated the reduced risk of adverse cardiac event among diabetic patients. Similarly, the decline in plasma homocysteine level is indicative of prevention from endothelial dysfunction.

[00123] A study has been conducted to compare the efficacy and safety of non-contact, low frequency airborne ultrasonic therapy using proposed device and standard treatment with sham therapy added to standard treatment in patients with diabetic foot ulcer (DFU).

[00124] The study design was a randomized, double-blind, sham-controlled single center study. Prospective patients with diabetes attending the foot care facility at a tertiary care hospital in North India, age 18 to 60 years with foot ulcers (wound size of at least 2 cm2), Wagner Grades 2 or 3 and an ankle-brachial index (ABI) of > 0.5 were included in the study. Patients with foot ulcer of aetiologies other than diabetes, gangrene of the foot, ischemic heart disease, congestive heart failure, hepatic disease (liver enzymes >2.5 times ULN), chronic kidney diseases (eGFR<45ml/min/l.73m2), pregnant and lactating women, patients taking immunosuppressive medications like glucocorticoids, cytotoxic drugs and patients with a history of chronic alcoholism or substance abuse were excluded from the study. The study was conducted in accordance with the principles set forth in the Helsinki International Wound Declaration (7th revision amended in October 2013) and as per ICH - GCP guidelines. The study protocol was approved by the institute Ethics Committee and a written and informed consent was obtained from all the participants.

[00125] Seventy patients with neuropathic, clinically infected or non-infected DFU (wound size > 2 cm2), Wagner Grade 2 and 3 with ankle -brachial index (ABI) of >0.5 were included. Patients received ultrasonic therapy ( as enabled using proposed transducer assembly ) sham therapy for 28 days dosed daily for first 6 days followed by twice a week for next 3 weeks along with standard of care for DFU including debridement, antibiotics for infected wounds, dressings and offloading. Wound size was measured during each visit and automated area calculation was performed with wound zoom camera.

[00126] The data for fifty-eight patients was finally evaluated. The duration of wound was

15.8 +/- 11.2 weeks and 12.1 +/- 10.9 weeks and wound area of 11.3 +/- 8.2 cm 2 and 14.8 +/-

13.8 cm (p=0.507) in the ultrasonic and sham group, respectively. A 50% reduction in wound area was observed in 39 patients with 61.5% and 38.5% subjects (p=0.042) and complete wound closure was observed in 11 subjects with 72.7% and 27.3% (p=0.033) in ultrasound and sham group, respectively. The reduction in wound area was 69.4+/- 23.2% and 59.6 +/- 24.9% (p=0.l26) in the ultrasound and sham group, respectively. The rate of wound contraction was faster in first two weeks among patients with ultrasound therapy compared to sham treatment.

[00127] As can be concluded from above, the airborne low frequency ultrasonic therapy provided by proposed transducer assembly improves and hastens healing of chronic neuropathic DFU when combined with standard wound care.

[00128] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

[00129] Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C ....and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

[00130] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.

ADVANTAGES OF THE INVENTION

[00131] The present disclosure provides a transducer assembly that generates non-contact, variable-intensity, multi-frequency, multi-beam and multi-directional energy waves comprising any or a combination of ultrasonic waves and sonic waves.

[00132] The present disclosure provides a transducer assembly that generates energy waves having multiple resonant frequencies spanning over various sonic and ultrasonic ranges, to have a wide band response to target different diseases and organs with specific frequency and intensity.

[00133] The present disclosure provides a transducer assembly that effectively shapes a wavefront to obtain multi-beam and multi-directional energy wavefront with variable amplitude/intensity.

[00134] The present disclosure provides a transducer assembly that creates a vibrational environment to stimulate cells of human body into a nascent state using the energy waves generated thereof.