BACKGROUND

A variety of methods and systems and methods exist to treat tissue, including mechanical means, lasers and other photon-based sources, radio frequency (RF) electrical currents, microwaves, cryogenic based techniques, and their various combinations, among others.

Each of these modalities has limitations which prevent a high degree of spatial control and precision during treatment. For example, in tissue the extreme absorption and scattering of photons relegates light based therapies to superficial applications that are tissue specific. Typically, electric currents, such as those emitted from a RF source, flow along the path of least impedance and are diffuse and non-selective, with maximum effect to tissue at the source. Further, the centimeter wavelengths of microwaves preclude tight focusing and energy placement in tissue.

Ultrasound can provide depth and precision of energy placement in tissue; however, it has currently been limited in application to either broad planar sources such as used in physiotherapy treatment, or as a single beam of focused sound, which is scanned sequentially over numerous areas, either electronically or mechanically, which is slow. Array based systems which can produce multiple sound beams are cumbersome and expensive and cannot in general produce output energy with a high degree of control or flexibility.

What is needed is an ultrasound treatment method and system that can provide simultaneous multiple beams of controlled energy to produce fractionated intense energy effects, such as thermal effects.

SUMMARY

Methods and systems for ultrasound treatment are provided. Acoustic energy, including ultrasound, under proper functional control can penetrate deeply and be controlled precisely in tissue. In various embodiments, methods and systems can be configured for ultrasound treatment based on creating an input energy distribution, passing it through apertures in a mask, which act in parallel as secondary acoustic sources to create an output distribution function. In various embodiments, methods and systems can be configured to create and control a desired temperature distribution.

Some embodiments provide an ultrasound treatment system configured for temporarily or permanently affecting tissue or its physiology. The ultrasound treatment system can comprise an energy source configured for delivery of acoustic or other energy to a treatment region; a control system for facilitating control of the energy source; and a set of masks, apertures, mask components, input/output, and secondary systems in communication with the control system to define a spatio-temporal distribution of the energy in the treatment region.

Some embodiments provide a method for providing ultrasound treatment. The method can comprise localizing a treatment region; delivering acoustic energy from an energy source into the treatment region; controlling the delivery of acoustic energy; producing at least one treatment effect in the treatment region of interest, with the delivering acoustic energy. The method can further comprise monitoring of results of the ultrasound treatment during and/or after of the delivery of acoustic energy. The method can further comprise planning of additional treatment,

DRAWINGS

The present disclosure will become more fully understood from the description and the accompanying drawings, wherein:

Figure 1 is a block diagram illustrating an ultrasound treatment system and method, in accordance with various non-limiting embodiments;

Figure 2A is a diagram illustrating an ultrasound treatment system mask, in accordance with various non-limiting embodiments;

Figures 2B-E are a set of graphs each illustrating spatial pressure distributions, in accordance with various embodiments;

Figure 2F is a plot illustrating transition depth versus frequency in accordance with various non-limiting embodiments;

Figure 3 is a block diagram illustrating various methods and systems of ultrasound treatment, in accordance with various non-limiting embodiments;

Figure 4 is a diagram illustrating set of different mask and transducer configurations, in accordance with various non-limiting embodiments;

Figure 5 is a block diagram illustrating an exemplary ultrasound treatment system in accordance with various non-limiting embodiments;

Figure 6 is a block diagram illustrating an exemplary ultrasound treatment system, in accordance with various non-limiting embodiments;

Figure 7 is a block diagram illustrating an exemplary ultrasound treatment system in accordance with various non-limiting embodiments; Figure 8 is a spatio-temporal equation describing various ultrasound fields, in accordance with various non-limiting embodiments;

Figure 9 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

Figure 10 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

Figure 1 1 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

Figure 12 is a block diagram illustrating an acoustic treatment system in accordance with various embodiments:

Figure 13 is a block diagram illustrating an acoustic treatment system in accordance with various non-limiting embodiments;

Figure 14 is a set of graphs illustrating various spatial acoustic functions in accordance with various non-limiting embodiments;

Figure 15 is a set of graphs illustrating various temporal acoustic functions in accordance with various non-limiting embodiments;

Figure 16 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments;

Figure 17 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments; and

Figure 18 is a graph illustrating a spatial temperature function in accordance with various non-limiting embodiments.

DESCRIPTION

The following description is mere!y exemplary in nature and is in no way intended to limit the various embodiments, their application, or uses. As used herein, the phrase "at least one of A, B, and C" should be construed to mean a logical (A or B or C), using a nonexclusive logical "or," As used herein, the phrase "A, B and/or C" should be construed to mean (A, B, and C) or alternatively (A or B or C), using a non-exclusive logical "or," It should be understood thai steps within a method may be executed in different order without altering the principles of the present disclosure.

The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of any of the various embodiments disclosed herein or any equivalents thereof, It is understood that the drawings are not drawn to scale, For purposes of clarity, the same reference numbers will be used in the drawings to identify similar elements.

The various embodiments may be described herein in terms of various functional components and processing steps. It should be appreciated that such components and steps may be realized by any number of hardware components configured to perform the specified functions. For example, various embodiments may employ various medical treatment devices, visual imaging and display devices, input terminals and the like, which may carry out a variety of functions under the control of one or more control systems or other control devices. In addition, the embodiments may be practiced in any number of industrial or medical contexts and that the various embodiments relating to a method and system for ultrasound treatment as described herein are merely indicative of exemplary applications for the invention. For example, the principles, features and methods discussed may be applied to any industrial or medical application. Further, various aspects of the various embodiments may be suitably applied to cosmetic applications. Moreover, some of the embodiments may be applied to cosmetic enhancement of skin and/or various subcutaneous tissue layers.

According to various embodiments described herein, methods are provided to create tailored space-time acoustic energy distributions in a treatment region. Various embodiments provide controlling delivery of acoustic energy into a treatment region by modulating an input energy distribution with a mask to create an output energy distribution. Since temperature in a targeted portion of a treatment region is proportional to the intensity of acoustic energy that is delivered, various embodiments provide controlling delivery acoustic energy into a treatment region which exceeds a threshold of cell death,

Various embodiments provide an ultrasound system configured for concentration of energy and increased power output to treat tissue in a region of interest. Some embodiments include an ultrasound system comprising a mask, which provides a greater intensity of ultrasound energy from the mask than the intensity the ultrasound intensify from the source. In some embodiments, the intensity of ultrasound energy at the mask can be tuned to different depths or sizes of lesions or shapes by tailoring the size of the aperture and the width of the mask. In some embodiments, the source is the primary source of ultrasound energy and the energy that is output of the mask is the secondary source of energy.

In some embodiments the mask can be cooled to control the tissue temperature in the region of interest. When using the ultrasound system at shallow depths in tissue, the coupling medium fills the apertures. In some embodiments, high-frequency can improve the targeting shallow depths within the tissues of the region of interest. In some embodiments, the primary source provides ultrasound energy to a mask comprising a plurality of apertures which converts the primary energy into a new energy field at the exit of each aperture, which is the secondary source. In some embodiments, the width of the mask can be thicker which can configure the aperture as a waveguide. In some embodiments, the thickness of the mask can tune the energy field of the secondary source.

In some embodiments, the mask may be shaped (i.e. not flat) and can be configured to focus energy to one point. In some embodiments, the ultrasound system comprising mask can create a lesion in a surface of skin. The mask can be configured to create a lesion at a surface of skin in a region of interest. In some embodiments, the ultrasound system can comprise a temperature modulator coupled to or integrated into mask and configured to modulate the temperature of the mask. For example, the temperature of the mask can be modulated using electric currents or Peltier modules. Modulating temperature of the mask can be used to configure the secondary source of energy for treatment of a surface of the skin. Modulating temperature of the mask can be configured for use of a photon-based energy source, which can be a tertiary source of energy. Typically, the mask will absorb acoustic or ultrasound energy such that the mass does not heat by absorbing the ultrasound energy.

Various embodiments provide methods and systems for concentrating sound energy source onto mask of apertures to produce treatment effects. In some embodiments, the apertures can yield greater power output than if aperture area was covered by a transducer alone. The apertures can be varied sizes and shapes to create treatment effects of varied sizes, depths, and shapes. In some embodiments, the acoustic energy can contain one or more frequencies to produce varied sizes, depths, and shapes of treatment.

In some embodiments, the apertures can include auxiliary components, such as, for example, thermal control components. In some embodiments, a coupling medium between sound energy source and mask can be liquid and include thermal hydraulic, and/or pneumatic control. A liquid coupling medium can be dispensed through apertures to provide external coupling to treatment area, The coupling medium can be temperature controlled.

In some embodiments, the treatment effect can be a thermal effect in tissue in a region of interest. In some embodiments, a treatment effect can be a non- thermal effect in tissue in a region of interest. In some embodiments, a treatment effect can start below the surface or extend to the surface of skin, Tn some embodiments, sound energy and mask of apertures can vary in three dimensions and/or be time varying.

In some embodiments, the ultrasound treatment system can be combined with ultrasound imaging. In some embodiments, the ultrasound treatment system can be treatment system combined with other imaging, other sensing systems, and/or tissue parameter monitoring systems. In some embodiments, the ultrasound treatment system can be combined with a photon based, F current, or other energy source.

Various embodiments provide a ^' method for providing ultrasound treatment, in some embodiments, emitting primary ultrasound energy field from primary energy source; directing the primary ultrasound energy field into a plurality of apertures in a mask; converting the primary ultrasound energy field into a plurality of secondary ultrasound energy fields having an increased intensity; delivering the plurality of secondary ultrasound energy fields into a treatment region comprising the tissue; and initiating a thermal effect in the treatment region.

In some embodiments, the method can further comprise monitoring of results of the at least one treatment effect in the treatment region during the delivering the output energy. In some embodiments, the method can further comprise monitoring of results of the at least one treatment effect in the treatment region after the delivering the output energy. In some embodiments, the method can further comprise planning of additional treatment.

In some embodiments, the at (east one treatment effect is a cosmetic enhancement. In some embodiments, the at least one treatment effect is at least one of coagulation, increased perfusion, reduction of inflammation, generation of heat shock proteins, and initiation of healing cascade. In some embodiments, the at least one treatment effect is peaking inflammation in the injury location and initiating a coagulation cascade in at least a portion of the treatment region. In some embodiments, the at least one treatment effect is stimulating collagen growth in a portion of treatment region. In some embodiments, the method can further comprising imaging the treatment region.

Various embodiments provide an ultrasound treatment system, in some embodiments, the system can comprise a primary energy source configured for delivery of primary ultrasound energy field; a mask configured to receive and convert the ultrasound energy into a secondary source configured to provide secondary ultrasound energy field; and a control system for facilitating control of the primary energy source and the secondary- energy source; wherein an intensity of the secondary ultrasound energy field is greater than the intensity of the primary ultrasound energy field.

In some embodiments, the mask comprising a plurality of apertures configured to convert the primary ultrasound energy field into the secondary ultrasound energy field. In some embodiments, the system can further comprise a temperature modulator coupled to the mask and operable to modulate a temperature of the mask. in some embodiments, the system can further comprise a photon based energy source configured to deliver photon based energy through the secondary energy source and into the treatment region. In some embodiments, the system can further comprise a radio frequency based energy source configured to deliver radio frequency energy through the secondary energy source and into the treatment region. Sn some embodiments, the output energy is configured to initiate a treatment effect in the treatment region.

Various embodiments provide an ultrasound treatment system, in some embodiments, the system can comprise a primary energy source configured for delivery of primary ultrasound energy field; a mask configured to receive and convert the ultrasound energy into a secondary source configured to provide a secondary ultrasound energy field; and a control system for facilitating control of the primary energy source and the secondary energy source; wherein an intensity of the secondary ultrasound energy field is greater than the intensity of the primary ultrasound energy field.

In some embodiments the thermal effect is one of heating the tissue, or creating a conformal region of elevated temperature in the treatment region. In some embodiments, the thermal effect is one of lesion creation in the region of interest, tissue necrosis in a portion of the treatment region; coagulation tissue in the treatment region, or exceeding a thermal capacity of tissue in a portion of the treatment region, and combinations thereof.

In some embodiments, the method can comprise controlling at least one of the primary energy source and the secondar energy source. In some embodiments, the method can comprise delivering a photon-based energy into the treatmen region and imitating a second treatment effect in the treatment region.

In some embodiments, a method can comprise localizing a treatment region; choosing a primary energy source, delivering acoustic input energy from a primary energy source through a plurality of mask apertures to create an output energy; delivering the output energy into the treatment region; and controlling the output energy to produce at least one treatment effect in the treatment region.

With reference to Figure 1 , a method of ultrasound treatment is illustrated. In various embodiments, ultrasound treatment method can comprise localizing a primary energy source 102 and delivering input energy 104 through a coupling medium 106 onto a mask 108 and through apertures 1 10, which, acting as secondary sources create output energy 1 12 in a treatment region 114, after passing through potential layers 1 16. In some embodiments, mask components 120 are mounted upon, adjacent to, or disposed within mask 108 and include passive or active temperature control components. In some embodiments, mask 108 can comprise temperature sensors, contact sensors, pressure sensors, position tracking sensors including optical position sensors, impedance sensors, transducers, absorbers, reflectors, membranes, matching layers, fluid control, hydraulic, and pneumatic components to name a few.

Primary energy source 102 and mask components 120 are controlled via control system 130, with associated software and methods. Control system 130 can comprise an input output (I/O) system 140, such as a touch panel, switches, indicators, and audible alarms. In some embodiments secondary systems 150 are also coupled to control system 130, and are configured for ultrasound imaging, therapy and/or monitoring 1 52, tissue parameter monitoring, in some embodiments, an additional energy source can provide laser or photon based therapies, radio frequency (RP) based therapy. Control system 130 can coupled and/or control impedance monitoring, video monitoring, motion control, and can also include memory devices such as EEP OMs or rechargeable batteries and systems for a portable, hand-held, or wireless ultrasound treatment system, in various embodiments, primary energy source 102 is an ultrasound or other acoustic source. In various embodiments, primary energy source 102 can be composed of single or multiple element cylindrical, spherical, planar, lensed or electronically phased or unfocused acoustic sources or their combination in any geometric configuration, power amplitude, and timing, creating any spatial and temporal distribution of input energy 104, In various embodiments, ultrasound based primary energy source 102 is composed of lead zirconate titanate piezoelectric ceramics or other transducer materials such as lithium niobate. In various embodiments, coupling medium 106 is liquid, in various embodiments, coupling medium 306 is a gel. In various embodiments, coupling medium 106 is a solid. In various embodiments, coupling medium 106 is a gas. In various embodiments, coupling medium 106 is a composite material. In various embodiments, treatment region J 14 (or region of interest) comprises a skin surface and subcutaneous tissue below. In various embodiments, treatment region 1 14 comprises an organ or artificial or engineered tissue. In various Industrial embodiments, treatment region 1 14 can comprise plastic or other materials to be treated by output energy 1 12. In various embodiments, ultrasound treatment system and method are used extracorporally. In other embodiments, ultrasound treatment system and method are used intracorporally or both.

In various embodiments mask 108 is metal. In various embodiments mask 108 is a composite. In various embodiments, mask 108 is multi layered. In various embodiments, mask 108 can move manually or via motion mechanism or can be exchanged for other masks. In various embodiments, apertures 1 10 are holes. In various embodiments, coupling medium 106 is solid, apertures 1 10 are solid and conduct sound, and mask 108 is a void or composed of materials that otherwise do not conduct sound. In various embodiments, mask ] 08 is covered by a membrane. In various embodiments, apertures 1 10 are passive or active materials. In various embodiments, apertures 1 10 are flat or shaped, such as iensed. In various embodiments, apertures 1 10 are waveguides. In various embodiments, mask 108 partially transmits sound through potential layers 1 16 into treatment region 1 14. In various embodiments, mask 108 can absorb sound. n various embodiments, mask 108 can reflect, deflect, and/or diffuse some or all of input energy 104.

In various embodiments, output energy 1 12 creates a mechanical effect in treatment region 3 14. For example, a mechanical effect can be any one of or any combination of cavitation, vibration, hydrodynamic, resonance-induced, streaming, vibro-accoustic stimulation, or a pressure gradient. In various embodiments, output energy 1 12 creates an ablative effect in treatment region 1 14. For example, an ablative effect can be any one of or any combination of lesion creation, tissue necrosis, coagulation, or exceeding a thermal capacity of tissue, or combinations thereof. In various embodiments, output energy 1 12 creates a thermal effect in treatment region 1 14. For example, a thermal effect can be at least one of heating subcutaneous tissue, creating a conformal region of elevated temperature, or creating conformal region of elevated temperature and a second conformal region of elevated temperature, or combinations thereof.

in various embodiments, output energy 1 12 can trigger (initiate and/or stimulate) one or more bio-effects in treatment region 1 14. A biological effect can be stimulating or increase an amount of heat shock proteins. Such a biological effect can cause white blood cells to promote healing of a portion of subcutaneous tissue in treatment region 1 14. A biological effect can be to restart or accelerate the wound healing cascade in treatment region 1 14 and/or in tissue proximate thereto. A biological effect can be increasing the blood perfusion in treatment region 114 and/or in tissue proximate thereto. A biological effect can be encouraging collagen growth, A biological effect may increase the liberation of cytokines and may produce reactive changes in treatment region 1 14 and/or in tissue proximate thereto. A biological effect may by peaking inflammation in treatment region 1 14 and/or in tissue proximate thereto. A biological effect may at least partially shrinking collagen portion in treatment region 1 14 and/or in tissue proximate thereto. A biological effect may be denaturing of proteins in treatment region 1 14 and/or in tissue proximate thereto,

A biological effect may be creating immediate or delayed cell death (apoptosis) in treatment region 114 and/or in tissue proximate thereto. A biological effect may be collagen remodeling in treatment region 1 14 and/or in tissue proximate thereto. A biological effect may be the disruption or modification of biochemical cascades. A biological effect may be the production of new collagen. A biological effect may be a stimulation of cell growth in treatment region 1 14 and/or in tissue proximate thereto. A biological effect may be angiogenesis. A biological effect may be a cell permeability response. A biological effect may be an enhanced delivery of medicants to treatment region 1 14 and/or to tissue proximate thereto,

i various embodiments, output energy 1 12 can initiate and/or stimulate one or more biological responses in treatment region 1 14, such as, those described herein. For example, a hioiogical response can be at least one of diathermy, hemostasis, revascularization, angiogenesis, growth of interconnect! ve tissue, tissue reformation, ablation of existing tissue, protein synthesis and/or enhanced cell permeability.

With reference to Figure 2A and according to various embodiments, an ultrasound treatment system, can comprise an input energy 104 of one or more wavelengths lambda, , incident on a mask 108, with apertures 1 10 of dimensions s per side, thereby creating an output energy 1 12 in the treatment region 1 14. Referring now to Figures 2B to 2E the spatial distribution of output energy 1 12, in the treatment region 1 14 is Illustrated from a single aperture 1 10 as the side, s, of the aperture is increased from λ/2 to λ to 2λ to 10λ, respectively. For example, acoustically small apertures, i.e. λ < 1, the lateral (along x or y) and axial (along z) normalized pressure magnitude follow a smooth and monotonia- contour, However, for acoustically large apertures, λ > 1 , constructive and destructive acoustic interference in the treatment region 1 14 create a more complex output energy distribution, with an axial peak occurring near the so-called far-field transition distance, s"/4X, for a square aperture of side s, or c /X for a circular aperture of radius . With reference to Figure 2F, in various embodiments, mask 108, apertures 1 10, energy source 102, mask components 120, and control system 130 are configured to place the free-field maxima of output energy 1 12 at a desired depth in the treatment region 1 14, In various embodiments lensed apertures can further control the acoustic field spatial distribution in the treatment region 1 14.

Moving to Figure 3, in some embodiments the input acoustic energy 104, mask 108, and apertures 1 10 create an output energy 1 12 creating a treatment effect 302, such as a thermal effect, whose depth 304 in the treatment region 1 14 is optionally modulated via mask components 120, such as temperature control components. In various embodiments, the desired treatment effect 302 can include the surface. In various embodiments, changing the frequency of input energy 104 is configured to move the position of treatment effect 302 and/or provide multiple depths of treatment effect 302, In various embodiments, mask 108 may include components such as a layers 108A, such as a membrane layer or other layers, with or without apertures 1 10, which may be used to retain a liquid coupling medium 106. In various embodiments layer 108A is a plastic film. In various embodiments, treatment effect 302 can occur at various angles with respect to mask 108 based on magnitude and phase of input energy 104 at aperture 1 10. In various embodiments at least one of treatment effect 302 can intersect in the treatment region 1 14.

Various embodiments of masks 108 and apertures 1 10 are illustrated in Figure 4. Aperture 1 1 OA illustrates a large opening or mesh-like mask 108, while in contrast aperture 1 10B is more closed, with smai!er apertures 1 10. In various embodiments the relative acoustic spacing between adjacent apertures 1 10 determines if their output energy 1 12 combines partially or fully in the treatment region 1 14 or can be considered as independent sound fields. In some embodiments, apertures HOC are placed in a random spatial pattern, within bounds, as opposed to a rectilinear or other periodic pattern, and can used to obscure potential treatment side effects, such as temporary edema or erythema on the surface of skin. In various embodiments, mask 108 has multiple sized or shaped apertures, such as apertures HOD and HOD ^' which can create multiple patterns of output energy 1 12 in the treatment region 1 14. In various embodiments, at least two different diameter or sized apertures H OD and M OD' create two different depths of treatment. In various embodiments, at least two different diameter or sized apertures HOD and H OD ^' create two different sized treatment regions. In various embodiments, mask 108 can consist of a line of apertures 1 10E or multidimensional apertures I I OF, such as slots, which can produce different field patterns of output energy 1 12 along different axes. In various embodiments, mask 402 can be split into more than one zone and secondary systems 150, can be integrated, such as a transducer for an ultrasound imaging and monitoring system. In various embodiments, transducer can be configured in-line along mask 402 or transverse or along the center of a mask 404,

According to various embodiments as illustrated in Figure 5, the primary energy source 102 is a spherically focused or leased ultrasound source, which concentrates acoustic input energy 104 emitted from a large surface area (e.g. a spherical shell) through an enclosed coupling medium 106, such as water, onto a mask 1 08, such as a stainless steel mask, and through apertures 1 10, to create a pattern of output energy 1 12 in the treatment region 1 14. In such embodiments, the level of output energy 1 12 can be made very intense, even if emitted from a small aperture 1 10, and such intense sound levels can be exploited in the treatment region 1 14 for treatment effects 302 such as thermal effects. Such embodiments illustrate that even if the aperture 108 is physically small or acoustically small a large amount of power can be emitted at the aperture 1 10. Such large power output may not be easily- deliverable if a single active transducer element was disposed at aperture 1 10. In various embodiments, a fluid coupling medium 106 can be held above atmospheric pressure or consist of a material that can avoid cavitation. In various embodiments, a fluid reservoir ears be used to maintain the level of coupling medium 106. Various embodiments may be used to output fluid coupling medium 106 to provide external acoustic coupling to treatment region 1 14.

According to various embodiments and with reference to Figure 6, the primary energy source is a cylindrical ly focused ultrasound source, which concentrates acoustic input energy 104 emitted from a large surface area (e.g. cylindrical shell) onto a mask 108 and through apertures 1 10, to create a pattern of output energy 1 12 in the treatment region 1 14, In various embodiments, the primary energy source is a phased array, including phase variation and/or beam steering, and including beamforming over the mask 108 and apertures 1 10.

According to various embodiments, as illustrated in Figure 7, a primary energy source focuses an incident acoustic input energy 104 onto a mask 108, and a portion of such incident acoustic energy 104 is reflected back by such mask 108 as reflected input energy 104 ^' which is then absorbed by an absorber 702. In one embodiment, an opening in the primary energy sourc can allow the reflected input energy 104' to pass through. In another embodiment, the absorber 702 is on the surface of or in front of the source. In another embodiment the primary source is electrically isolated where the reflected energy impinges on it, such electrically isolated region electronically damped by a network including a resistor. In another embodiment, opening in primary energy source 102 includes plastic tubing which absorbs and attenuates sound while serving as a liquid coupling fluid hydraulic control.

Moving to Figure 8, a mathematical relationship 802 encapsulates the ultrasound treatment system as a spatio-temporal input energy 104 distribution function li(x, y, z, t), which is modulated by a spatio-temporal aperture 110 mask 108 function M(A y, z, t) to create a spatio-temporal output energy 1 12 distribution function ϋ) χ, y, z, t). As such, any acoustic field distribution and timing can be synthesized for the output energy function 1 12. Of note, in various embodiments mask surface can be three-dimensional and/or time varying.

In various embodiments, ultrasound treatment system 1 00 is an entire system capable of at least one of treating, imaging, or monitoring, before, during and after treatment, using at least one of acoustic energy and any other energy source, including for example laser, photon emission, and/or radio frequency energy. In one embodiment, ultrasound treatment system 100 comprises acoustic primary energy source 102, control system 130, and at least one other energy source, all encompassed in one unit.

Various embodiments provide a method for providing ultrasound treatment. The method can comprise localizing a treatment region 1 14, choosing a primary energy source 102, delivering acoustic input energy 104 from the primary energy source 102 through the mask 108 apertures 1 10 and into the treatment region 114, and controlling the output energy 1 12 to produce at least one treatment effect 302 in the treatment region 1 14. The method can further comprise monitoring of results of the ultrasound treatment during and/or after of the delivery of acoustic output energy 1 12. The method can further comprise planning of additional treatment. In some embodiments, the method is a method of cosmetic enhancement.

The method can comprise providing at least one bio-effect in the in at least one treatment region 1 14, The method can comprise destroying tissue in the at least one treatment region 1 14. The method can further comprise generating at least one bioiogicai effect in tissue proximate to the at least one treatment region 1 14. Control of one or more parameters of the ou tput energy 1 12, defines the explicit shape of the treatment region 114 to affect ultrasound treatment. As will be apparent to those of ordinary skill in the art, output energy 1 12 can be employed in any method and/or system described herein, it should be appreciated that designated treatment effect 302 has a conibrmal volume that can be spatially and temporally controlled by ultrasound treatment system 100 and expanded in one or more conformal volumes. Such effect will produce one or more distinct zones of controlled and predictable parameters and dimensions by either electronic and/or mechanical displacements of the acoustic primary energy source, 102 and associated components, mask 108, etc.

As used herein, the term cosmetic enhancement can refer to procedures, which are not medically necessary and are used to improve or change the appearance of a portion of the body. For example, a cosmetic enhancement can be a procedure that is used to improve or change the appearance of a nose, eyes, eyebrows and/or other facial features, or to improve or change the appearance and/or the texture and/or the elasticity of skin, or to improve or change the appearance of a mark or scar on a skin surface, or to improve or change the appearance and/or the content of fat near a skin surface, or the targeting of a gland to improve or change the appearance a portion of the body. Since it is not medically indicated for improving one's physical well-being, cosmetic enhancement is an elective procedure. As used herein, cosmetic enhancement does not diagnose, prevent, treat, or cure a disease or other medical condition. Furthermore, cosmetic enhancement is not a method for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. Cosmetic enhancement is a non-surgical and non-invasive procedure. In some embodiments, cosmetic enhancement can be a non-surgical and non-invasive procedure that is performed at home by a user who is not a medical professional.

Various embodiments can include energy source which is controlled via spatial and temporal parameters that are programmable to create predictable thermal field distribution. In various embodiments, system can comprise an energy source, which can be controlled by an acoustic energy function. In some embodiments, acoustic energy function provides parameters for spatial parameters and temporal parameters of energy source. Energy source provides energy into a medium that comprises a ROl. In some embodiments, the acoustic energy function controls an energy emission from energy source into a targeted portion of the medium. In some embodiments, the targeted portion of the medium is the region of interest.

Medium can be any solid, liquid, gas or combinations thereof. Medium cannot be a vacuum. In various embodiments, the medium is homogenous. In various embodiments, thermal resistance (thermal conductivity) and thermal capacity (specific heat) is at least one fixed or constant or linear. In various embodiments, the medium is in a closed system. In some embodiments, medium is soft tissue. In some embodiments, medium comprises at least one of subcutaneous tissue and a surface above the subcutaneous tissue.

The acoustic energy function controls an energy emission distribution that is deposited into ROI. in some embodiments, the acoustic energy function provides precise spatial and temporal control of acoustic energy deposition. Accordingly, control of the energy source is confined within selected time and space parameters, with such control being independent of the medium.

In various embodiments, the interaction of the energy emission distribution with the medium creates a thermal energy distribution in the ROI. In various embodiments, the thermal energy distribution is defined by a temperature function, which has four dimensions, x, y, z, and L where t is time at which a temperature is measured at coordinates x, y, and z. The thermal energy distribution is time dependent. The thermal energy distribution can be a conformal volume of deposition of thermal energy. The thermal energy distribution is a volume in the medium, having three dimensions x, y, and z. A boundary of distribution defines the thermal energy distribution within the boundary and the medium outside the boundary. The boundary of distribution is transparent to thermal energy if thermal capacity of medium is constant, The boundary of distribution is definable and thus is selectable by system. Since boundary of distribution is definable, energy source as programmable and/or controlled by acoustic energy function can provide a conformal energy emission distribution to create the thermal energy distribution within the defined boundary in the ROI.

In various embodiments, the thermal distribution field interacts with the medium to create an effect. Different thermal distribution fields create different temperature levels in the medium. The effect created in the medium is dependent on the temperature levels in the medium. In various embodiments, the effect can be one of but limited to ablation, cavitation, a resonance effect or mechanical energy. In some embodiments, the thermal energy distribution creates a conformal elevated temperature distribution.

Typically, ultrasound energy propagates as a wave with relatively little scattering, over depths up to many centimeters in tissue depending on the ultrasound frequency. The focal spot size achievable with any propagating wave energy depends on wavelength. Ultrasound wavelength is equal to the acoustic velocity divided by the ultrasound frequency. Attenuation (absorption, mainly) of ultrasound by medium also depends on frequency. Shaped conformal distribution of elevated temperature can be created through adjustment of the strength, depth, and type of focusing, energy levels and timing cadence. For example, focused ultrasound can be used to create precise arrays of microscopic thermal ablation zones. Ultrasound energy can produce an array of ablation zones deep into the medium, such as for example, layers of the soft tissue. Detection of changes in the reflection of ultrasound energy can be used for feedback control to detect a desired effect on the medium and used to control the exposure intensity, time, and/or position.

In various embodiments, energy source can be configured with the ability to controllably produce conformal distribution of elevated temperature in medium within a ROI through precise spatial and temporal control of acoustic energy deposition, i.e., control of ultrasound probe is confined within selected time and space parameters, with such control being independent of the medium. The ultrasound energy can be controlled using spatial parameters. The ultrasound energy can be controlled using temporal parameters. The ultrasound energy can be controlled using a combination of temporal parameters and spatial parameters.

In accordance with various embodiments, control system and energy source can be configured for spatial control of ultrasound energ by controlling the manner of distribution of the ultrasound energy. For example, spatial control may be realized through selection of the type of one or more transducer configurations insonifymg ROI, selection of the placement and location of energy source for delivery of ultrasound energy relative to ROI e.g., energy source being configured for scanning over part or whole of ROI to produce contiguous thermal effect having a particular orientation or otherwise change in distance from ROI, and/or control of other environment parameters, e.g., the temperature at the acoustic coupling interface can be controlled, and/or the coupling of energy source to tissue. Other spatial control can include but are not limited to geometry configuration of energy source or transducer assembly, lens, variable focusing devices, variable focusing lens, stand-offs, movement of ultrasound probe, in any of six degrees of motion, transducer backing, matching layers, number of transduction elements in transducer, number of electrodes, or combinations thereof.

In various embodiments, control system and energy source cars also be configured for temporal control, such as through adjustment and optimization of drive amplitude levels, frequency, waveform selections, e.g., the types of pulses, bursts or continuous waveforms, and timing sequences and other energy drive characteristics to control thermal ablation of tissue. Other temporal control can include but are not limited to full power burst of energy, shape of burst, timing of energy bursts, such as, pulse rate duration, continuous, delays, etc., change of frequency of burst, burst amplitude, phase, apodization, energy level, or combinations thereof.

The spatial and/or temporal control can also be facilitated through open-loop and closed-loop feedback arrangements, such as through the monitoring of various spatial and temporal characteristics, As a result, control of acoustical energy within six degrees of freedom, e.g., spatially within the X, Y and Z domain, as well as the axis of rotation within the XY, YZ and XZ domains, can be suitably achieved to generate eonformal distribution of elevated temperature of variable shape, size and orientation. For example, through such spatial and/or temporal control, energy source can enable the regions of elevated temperature distribution possess controlled that is based on the function.

In some embodiments, the ultrasound energy may be unfocused and deposited in a volume that spans from the surface of the medium into a portion of the medium below. The ultrasound energy can have any of the characteristics as described herein. The ultrasound energy can be controlled using spatial parameters, The ultrasound energy can be controlled using temporal parameters. The ultrasound energy can be controlled using a combination of temporal parameters and spatial parameters.

Since temperature in a. targeted portion of a region of interest is proportional to an intensity of acoustic energy that is delivered, various embodiments provide controlling a delivery acoustic energy into a region of interest using a distribution function, which exceeds a thermal capacity of tissue in the region of interest. Some embodiments provide controlling a delivery acoustic energy into a region of interest using a distribution function, which exceeds a threshold of cell death in a targeted portion of the region of interest. Various embodiments provide controlling a delivery acoustic energy into a region of interest using a distribution function, which does not exceed a thermal capacity of tissue in the region of interest. Various embodiments provide controlling a delivery acoustic energy into a region of interest with a step function.

A method and system for acoustic treatment of tissue are provided. Acoustic energy, including ultrasound, under proper functional control can penetrate deeply and be controlled precisely in tissue, in various embodiments, methods and systems can be configured for acoustic energy deposition into tissue based on creating an energy distribution function. In various embodiments, methods and systems can be configured based on creating temperature distribution function in a medium.

Some embodiments provide an acoustic treatment system configured for temporarily or permanently affecting tissue or its physiology. The acoustic treatmen system can comprise an energy source configured for deliver)' of acoustic or other energy to provide a treatment function to a region of interest; a control system for facilitating control of the energy source; and a set of functions, f(x,y,z,t), in communication with the control system and defining a spatio-temporal distribution of the energy to provide the treatment function in the region of interest.

In some embodiments, the set of functions, f(x,y,z,t), controls the thermal distribution of the acoustic energy delivered to the region of interest to provide the treatment function. In some embodiments, the set of functions, f(x,y,z,t), creates a desired temperature function in the region of interest.

in some embodiments, the system can further comprise an imaging function configured to image region of interest. In some embodiments, the system can further comprise a second energy source configured to deliver energy to provide the treatment function in the region of interest. In some embodiments, the second energy source is one a photon-based energy source, a RF energ source, and a microwave energy source.

in some embodiments, the method can further comprise monitoring of results of the treatment function during the delivery of acoustic energy. In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment after the delivery of acoustic energy, in some embodiments, the method can further comprise planning of additional treatment. In some embodiments, the function treatment initiates at less one thermal effect in the region of interest. In some embodiments, the at least one thermal effect is one of heating the region of interest, or creating a eonformai region of elevated temperature in the region of interest. In some embodiments, the thermal effect is one of lesion creation in the region of interest, tissue necrosis in a portion of the region of interest; coagulation tissue in the treatment region, or exceeding a thermal capacity of tissue in a portion of the region of interest, and combinations thereof.

In some embodiments, the treatment function initiates at least one mechanical effect in the region of interest. In some embodiments, the at least one mechanical effect is at least one of cavitation, vibration, hydrodynamic, resonance-induced, streaming, vibro-accoustic stimulation, a pressure gradient and combinations thereof.

Various embodiments provide a method for providing acoustic treatment of tissue. The method can comprise localizing a region of interest; computing a spatio-temporal treatment function, e(x _J y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatio-temporal treatment function, e(x,y,z,t); producing at least one treatment function in the region of interest with the delivering acoustic energy. In some embodiments, the method can further comprise monitoring of results of the treatment function during and/or after of the delivery of acoustic energy. The method can further comprise planning of additional treatment.

Various embodiments provide a method for providing acoustic treatment of tissue. In some embodiments, the method can comprise identifying at least one region of interest; computing a spatio-temporal treatment, function, e(x,y,z,t); delivering acoustic energy from an energy source into the region of interest; controlling the delivering acoustic energy with the spatio-temporal treatment function, e(x,y,z,t); producing desired temperature function, T(x,y,z,t) in the at least one region of interest with the delivering acoustic energy. In some embodiments, the method can further comprise monitoring a temperature of the desired temperature function, T(x,y,z,t) in the at least one region of interest. The method can further comprise adjusting the delivering acoustic energy to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest.

In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy. The method can further comprise continue planning of treatment based on the results. The method can comprise providing at least one bio-effect in the in the at least one region of interest. The method can comprise destroying tissue in the at least one region of interest. The method can further comprise generating at least one bio-effect in tissue proximate to the at least one region of interest.

In some embodiments, the method can further comprise monitoring a temperature of the desired temperature function, T(x,y.z,t) in the at least one region of interest, in some embodiments, the method can further comprise adjusting the delivering acoustic energy to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest. In some embodiments, the method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy.

In some embodiments, the method can further comprise providing at least one biological effect in the in the at least one region of interest based in the temperature function. In some embodiments, the at least one biological effect is destroying tissue in the at least a portion of the region of interest.

In some embodiments, the method can further comprise generating at least one biological effect in tissue proximate to the at least one region of interest based in the temperature function. In some embodiments, the method can further comprise delivering a photon-based energy into the region of interest and imitating a treatment effect in the region of interest, In some embodiments, the method can further comprise delivering a radio frequency based energy into the region of interest and imitating a treatment effect in the region of interest.

With reference to Figure 9, a method of acoustic tissue treatment is illustrated, in various embodiments, acoustic tissue treatment method can comprise disposing an energy source 1 102 in a source region 1 104, delivering energy 1 1 15 through potential surfaces 1 10 into a region of interest 1 108, and creating a space-time acoustic energy function 1 1 12 in a targeted function region 1 106, In some embodiments, energy source 1 102 is an acoustic energy source delivering acoustic energy I S 15 to targeted function region 1 106. In some embodiments, energy source 1 102 is a combination of an acoustic energy source with at least one other energy source and is configured to deliver acoustic energy and at least one other energy to at least one of targeted function region 1106 and source region 1 104, including .subtraction of energy, e.g. via cooling.

in various embodiments, acoustic energy 1 1 15 propagates to or from energy source

1 102, including the form of communications energy. In various embodiments, energy source 3 102 is configured to emit ultrasound energy. In various embodiments, the acoustic energy function 11 12 can be an algebraic, geometric, convolution, or other mathematical combinations of one or more of the same or different functions for the same or different

3 energy source or sources 3 102, For example, acoustic energy function 1 1 12 can be defined as a function, of time, /, as well as space, represented by the three orthogonal axes x, y, and z, such that the energy distribution, e, can be represented compactly in a mathematical notation as e - f(x, y, z, t). in various embodiments, acoustic energy function 1 1 12 controls energy source 1 102 to create targeted function region 1 106, which in some embodiments is a thermal energy distribution. In some embodiments, a targeted function region 3 106 is a thermal voxel.

Potential surfaces 1 1 10, such as a tissue surface, may or may not exist between the energy source 1 102 and targeted fu ction region 1106, and in such cases the energy source 1 102 which lies within the source region 1 104 is also within the region of interest 1 308. in some embodiments, acoustic tissue treatment method is limited to a method of cosmetic enhancement, as described herein,

in various embodiments, acoustic energy function 3 3 12 creates a mechanical effect in targeted function region 1106. For example, a mechanical effect can be cavitation, vibration, hydrodynamic, resonance-induced, streaming, vibro-accoustic stimulation, or a pressure gradient or combinations thereof. In various embodiments, acoustic energy function 3 3 32 creates an ablative effect in targeted function region 1 106. For example, an ablative effect can be lesion creation, tissue necrosis, coagulation, or exceeding a thermal capacity of tissue, or combinations thereof, In various embodiments, acoustic energy function 1 1 12 creates a thermal effect in targeted function region 1 106.

For example, a thermal effect can be heating subcutaneous tissue, creating a eonformai region of elevated temperature distribution, or creating conformaS region of elevated temperature distribution and a second eonformai region of elevated temperature distribution, or combinations thereof. Shaped eonformai distribution of elevated temperature can be created through adjustment of the strength, depth, and type of focusing, energy levels and timing cadence.

In various embodiments, acoustic energy function 1 1 12 can trigger (initiate and/or stimulate) one or more biological effects in targeted function region 3 S 06. A biological effect can be stimulating or increase an amount of heat shock proteins. Such a biological effect can cause white blood cells to promote healing of a portion of subcutaneous tissue in targeted ^■ function region 1 1 6. A biological effect can be to restart or accelerate the wound healing cascade in targeted function region 1106 and/or in tissue proximate thereto. A biological effect can be increasing the blood perfusion in targeted function region 3 106 and/or in tissue proximate thereto, A. biological effect can be encouraging collagen growth. A biological effect may increase the liberation of cytokines and may produce reactive changes in targeted function region 1 106 and/or in tissue proximate thereto. A biological effect may by peaking inflammation in targeted function region 1 106 and/or in tissue proximate thereto, A biological effect may at least partially shrinking collagen portion in targeted function region 1106 and/or in tissue proximate thereto. A biological effect may be denaturing of proteins in targeted function region 1 106 and/or in tissue proximate thereto.

A biological effect may be creating immediate or delayed cell death (apoptosis) in targeted function region 1106 and/or in tissue proximate thereto. A biological effect may be collagen remodeling in targeted function region 1 106 and/or in tissue proximate thereto. A biological effect may be the disruption or modification of biochemical cascades. A biological effect may be the production of new collagen. A biological effect may a stimulation of cell growth in targeted function region 1 106 and/or in tissue proximate thereto. A biological effect may be angiogenesis. A biological effect may a cell permeability response. A biological effect may be an enhanced delivery of medicants to targeted function region 3 106 and/or to tissue proximate thereto.

In various embodiments, acoustic energy function 1 1 12 can initiate and/or stimulate one or more biological responses in targeted function region 1 106, such as, for example, diathermy, hemostasia, revascularization, angiogenesis, growth of interconnective tissue, tissue reformation, ablation of existing tissue, protein synthesis and/or enhanced ceil permeability.

Furthermore, various embodiments provide energy, which may be a first energy and a second energy, For example, a first energy may be followed by a second energy, either immediately or after a delay period. In another example, a first energy and a second energy can be delivered simultaneously. In some embodiments, the first energy and the second energy is ultrasound energy. In some embodiments, the first energy is ultrasound and the second energy is generated by one of a laser, an intense pulsed light, a light emitting diode, a radiofrequency generator, photon-based energy source, plasma source, a magnetic resonance source, or a mechanical energy source, such as for example, pressure, either positive or negative. In other embodiments, energy may be a first energy, a second energy, and a third energy, emitted simultaneously or with a time delay or a combination thereof. In some embodiments, energy may be a first energy, a second energy, a third energy, and an nth energy, emitted simultaneously or with a time delay or a combination thereof. Any of the a first energy, a second energy, a third energy, and a nth nay be generated by at least one of a laser, an intense pulsed light, a light emitting diode, a radiofrequency generator, an acoustic source, photon-based energy source, plasma source, a magnetic resonance source, and/or a mechanical energy source, in various embodiments, a second energy can be control by a second energy function. In some embodiments, a second thermal energy distribution is created by second energy source. In some embodiments, the thermal energy distribution and the second thermal energy distribution can be combined.

With reference to Figure 10 and according to various embodiments, an acoustic treatment system 1200, can comprise acoustic energy source 1 102 coupled either wirelessly or wired to control system 1 103. In some embodiments, acoustic treatment system 1200 can be configured whereby control system 1 103 and all control thereof is embedded in acoustic energy source 1102, such as for example, system 1200 being configured as a hand-held device. In some embodiments, acoustic energy source 1 102 and control system 1 103 are integrated into one unit. Control for control system 1 103 is exerted on acoustic energy source 1 102 to create a desired acoustic energy function 1 1 12 in targeted function region 1 106, In some embodiments, acoustic energy function 1 1 12 creates a desired temperature function in tissue. Acoustic energy source 1 102 can be controlled in terms of geometry, output power amplitude and timing and spatial distribution of source energy 1 1 15,

In various embodiments, acoustic treatment system 1200 can comprise energy source 1 102 configured for delivery of acoustic or other energy 1 1 15 to targeted function region 1 106, control system 1 103 for facilitating control of the energy source 1 102 and acoustic energy function 1 1 12, such as, for example, a set of functions, f ^' (x,y,z,f), in communication with control system 1 103 and defining a spatio-temporal distribution of the energy 1 1 1 5 in targeted function region 1 1.06.

In various embodiments, acoustic energy system 1200 is an entire system capable of at least one of treating, imaging, or monitoring, before, during and after treatment, using at least one of acoustic energy and any other energy source, including for example laser, photon emission, and/or radio frequency energy, in some embodiments, acoustic energy system 1200 comprises acoustic energy source Π 02, control system 1 103, and at least one other energy source, all encompassed in one uni

Various embodiments provide a method for providing acoustic treatment of tissue. The method can comprise localizing a region of interest 1108, computing a spatio-temporal treatment function, e(x,y,z,f), delivering acoustic energy 1 1 15 from an energy source 1 1 2 into the region of interest 1 108, controlling the delivering acoustic energy 1 1 15 with the spatio-temporal treatment function, e(x,y,z,t), producing at least one treatment function 1 106 in the region of interest 1 108 with the delivering acoustic energy 1 1 15, The method can further comprise monitoring of results of the acoustic tissue treatment during and/or after of the delivery of acoustic energy 11 15, The method can further comprise planning of additional treatment. In some embodiments, the method is a method of cosmetic enhancement.

Various embodiments provide a method for providing acoustic treatment of tissue.

The method can comprise identifying at least one region of interest 3 108, computing a spatio- temporal treatment function, e(x,y,z,t), delivering acoustic energy 1 1 15 from an energy source 1 102 into the region of interest 1 108, controlling the delivering acoustic energy 3 1 15 with the spatio-temporal treatment function, e(x,y,2,t), producing desired temperature function, T(x,y,z,t) in the at least one region of interest 1 108 with the delivering acoustic energy 1 1 15, The method can further comprise monitoring a temperature of the desired temperature function, T(x.y,z,t) in the at least one region of interest 1 108, The method can further comprise adjusting the delivering acoustic energy 1 1 15 to maintain the desired temperature function, T(x,y,z,t) in the at least one region of interest 1 108, The method can further comprise monitoring of results of the acoustic tissue treatment during and/or after the delivering acoustic energy J 1 1 5, The method can further comprise continue planning of treatment based on the results. The method can comprise providing at least one bio-effect in the in the at least one region of interest 1 108, The method can comprise destroying tissue in the at least one region of interest 1108, The method can further comprise generating at least one biological effect in tissue proximate to the at least one region of interest 1 108, In some embodiments, the method is a method of cosmetic enhancement,

Moving to Figure 1 1 , in some embodiments the acoustic energy source 1 102 is controlled to produce a specific acoustic energy function 340, e = a(t) [u(x - x>) - u(x - xi)} [u(y -yi) - u(y - y ] [u(z ^■■■■ ∑;) - u(z - z ₂ )] g(x, y, z), where u(y) is the step function 330, a(t) represents the time excitation, and g(x, y, z) represent the spatial modulation within the regions bound by [x _ls ¾ , [y _!t yj, and fzj, ¾/ along the axes 1320. Control of one or more parameters of the specific acoustic energy function 340, defines the explicit shape of the targeted function region 1 106 to affect acoustic tissue treatment. As will be apparent to those of ordinary skill in the art, acoustic energy function 1340 is a subset of acoustic energy function 1 1 12 and can be employed in any method and/or system described herein.

Specifically with respect to Figure 12, in some embodiments, a specific acoustic energy function 440, e = aft) u(z - zi) g(x, y, z), is created by the energy source 1 106 whereby an axial step function of energy is placed beginning at a depth z to define the acoustic targeted function region 1 106. This step function is further modulated by the spatial distribution g(x, y, z), and further defined by the temporal characteristic of excitation, a(t). in some embodiments, acoustic energy source 1 102 is controlled to achieve the desired specific acoustic energy function 1440, which can produce a step change in temperature at depth Furthermore, acoustic energy source 1 102 can be controlled to achieve the desired specific acoustic energy function 1440, which can produce a step change in temperature at a second depth (not shown in Figure 12), As will be apparent to those of ordinary skill in the art, acoustic energy function 440 is a subset of acoustic energy function 1 1 12 and can be employed in any method and/or system described herein,

It should be appreciated that designated conformal volume spatially and temporally controlled by functions described as a specific acoustic energy function 440, e - aft) \t(z - zi) g(x, y, z), could be expanded in one or more conformal volumes. Such effect will produce one or more distinct zones of controlled and predictable parameters and dimensions by either electronic and/or mechanical displacements of the acoustic energy source, 1 102, Further, the acoustic energy source 1 102 may be programmable to perform predictable and/or repeatable spatial and temporal energy transduction with or without feedback from a variety of monitoring parameters, such as tissue parameters, pressure, amplitude, energy absorption, and attenuation, to name a few,

In some embodiments as shown in Figure 13, a specific acoustic energy function 540, defined by e = (t) δ(χ - χη) S(y - >¾) δ(ζ - ZQ) g(x, y, z), where d(y) is a delta function 530, is created by controlling energy source 1 102, to produce an energy impulse at a location (x _ih )'o, zo) in the targeted tissue region 1 106, This specific acoustic energy function is further modulated by the spatial distribution g(x, y, ∑), and further defined by the temporal characteristic of excitation, aft). In some embodiments, the function produces an impulse change in temperature at position (x _& ye, zo). As noted, in various embodiments the specific acoustic energy function 1540 can be an algebraic, geometric, or convolution combination of one or more of the same or different functions for the same or different energy source or sources 1 102. As will be apparent to those of ordinary skiil in the art, acoustic energy function 1540 is a subset of acoustic energy function 1 1 12 and can be employed in any method and/or system described herein.

In various embodiments as shown in Figure 14, a plurality of functions as defined by acoustic energy functions 1612, e(x, y, 2, I). In the spatial domain, γ represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}. One of the plurality of functions is an impulse function 650. One of the plurality of functions is a step or square (two step) function 651 , One of the plurality of functions is a fast-attack slow-decay (or slow-attack fast-decay) function 652. One of the plurality of functions is a ramp 1653, One of the piurality of functions is a harmonic or sinusoidal function 1654. One of the plurality of ^" functions is a collection of impulses in space 1655, Any one of these plurality of functions can be disposed anywhere in the region of interest to produce an effect on tissue, as described herein. As will be apparent to those of ordinary skill in the art, acoustic energy functions 1612 are a subset of acoustic energy function 11 12 and can be employed in any method and/or system described herein.

In various embodiments as shown in Figure 15, a plurality of functions as defined by functions 1712, namely e(x, y, z, i). One of the piurality of functions in the time domain is an impulse function 1750. One of the plurality of functions in the time domain is a step or square (two step) function 1751. One of the plurality of functions in the time domain is a fast-attack slow-decay (or slow-attack fast-decay) function 752. One of the plurality of functions in the time domain is a harmonic or sinusoidal burst function 753. One of the plurality of functions in the time domain is a ramp 1754. One of the piurality of functions in the time domain is a collection of time samples or impulses in space 1 755. Any one of these plurality of functions can be disposed anywhere in the region of interest to produce an effect on tissue, as described herein. As will be apparent to those of ordinary skill in the art, acoustic energy functions 3712 are a subset of acoustic energy function 1 1 12 and can be employed in any method and/or system described herein,

Moving to Figure 16, a graph illustrates a temperature distribution function versus the spatial parameter γ which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z} . In various embodiments, temperature distribution 1860, such as a fast-attack temperature distribution, is disposed in space axially and or laterally and can be modified by algebraic, geometric, convoiuttonai, or other mathematical combinations thereof. Control of energy sources, e.g. cooling and or parametric control, can be used to change the position of any temperature distribution function in space to a proximal temperature distribution 862 or distal temperatur distribution 1 864.

Turning to Figure 17, a graph illustrates a temperature distribution function versus the spatial parameter γ which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z}, in various embodiments, temperature distribution I960, such as a square step or two-step temperature distribution, is disposed in space axially and or laterally and can be modified by algebraic, geometric, convolutional, or other mathematical combinations thereof for acoustic tissue treatment. Now with reference to Figure 18, a graph illustrates a temperature distribution function versus the spatial parameter γ which again represents a subset of, and substitution of variable for, one or more of the set of coordinates {x, y, z} . Temperature distribution 1060, such as an impulse temperature distribution, is disposed in space axia!ly and or lateral!)' and can be modified by algebraic, geometric, convo!utionai, or other mathematical combinations thereof for acoustic tissue treatment. Such algebraic combination is shown as 1062.

The following patents and patent applications are incorporated by reference: US Patent Application Publication No. 20050256406, entitled "Method and System for Controlled Scanning, Imaging, and/or Therapy" published November 17, 2005; US Patent Application Publication No, 20060058664, entitled "System and Method for Variable Depth Ultrasound Treatment" published March 16, 2006; US Patent Application Publication No. 20060084891 , entitled Method and System for Ultra-High Frequency Ultrasound Treatment" published April 20, 2006; US Patent No, 7,530,958, entitled "Method and System for Combined Ultrasound Treatment" issued May 12, 2009; US Patent Application Publication No. 2008071255, entitled "Method and System for Treating Muscle, Tendon, Ligament, and Cartilage Tissue" published March 20, 2008; US Patent No. 6,623,430, entitled " Method and Apparatus for Safely Delivering Medicants to a Region of Tissue Using Imaging, Therapy, and Temperature Monitoring Ultrasonic System, issued September 23, 2003; US Patent No. 7,571,336, entitled " Method and System for Enhancing Safety with Medical Peripheral Device by Monitoring if Most Computer is AC Powered" issued August 4, 2009; and US Patent Application Publication No. 20080281255, entitled "Methods and Systems for Modulating Medicants Using Acoustic Energy" published November 13, 2008.

While the invention has been disclosed herein, the specific embodiments thereof as disclosed and illustrated herein are not to be considered in a limiting sense as numerous variations are possible. The subject matter of the inventions includes all novel and non- obvious combinations and sub combinations of the various elements, features, functions and/or properties disclosed herein.

Various embodiments and the examples described herein are not intended to be limiting in describing the full scope of systems and methods of this invention. Equivalent changes, modifications and variations of various embodiments, materials, systems, and methods may be made within the scope of the present invention, with substantially similar results.