BRPI1001311A2 - ultrasound system and method - Google Patents

Abstract

ULTRASOUND SYSTEM AND METHOD This is an ultrasound system that is configured to determine whether a patient's adipose tissue has received therapy at a 222 treatment site. The system includes a 126 ultrasound probe and a shear wave generation module 123 to control probe 126 in order to provide a shear wave beam, which is configured to generate a shear wave at a first site in the patient. The shear wave is configured to propagate through the treatment site 222 towards a second site in the patient. The system also includes a tracking module 164 to control probe 126 in order to track the shear wave at the second site on the patient and determine whether treatment site 222 has received therapy.

Description

"Ultrasound System and Method" Cross Reference to Related Orders

This application includes material that is similar to the material described in US patent application number 235594 (555-0003US), entitled "ULTRASOUND SYSTEM AND METHOD TO AUTOMATICALLY DELIVER THERAPY BASED ON USER DEFINED TREATMENT SPACES," and . from Prosecutor's dossier 235615 (555-0004US) entitled "ULTRASOUND SYSTEM AND METHOD TO AUTOMATICALLY IDENTIFY AND TREAT ADIPOSE TISSUE," both of which are filed simultaneously with the present and are incorporated by reference in their entirety.

Background of the Invention

The subject matter of the present invention relates generally to ultrasound therapy systems that provide treatment of a region of interest in a patient, and more particularly to ultrasound systems that treat adipose tissue.

Several body shaping systems currently exist that attempt to remove or destroy fatty tissue (or fat tissue) from a person's body. Some systems may be invasive, such as liposuction, where a device is inserted into the body and physically removes fat by suction. Other systems may be noninvasive. For example, in a noninvasive system, high intensity focused ultrasound (HIFU) signals are directed to a target region within adipose tissue. HIFU signals can at least partially liquefy adipose tissue in the target region through lysis, cavitation, and / or thermal damage to cells.

In some known HIFU systems, an operator typically directs various therapy applications to separate locations in a region of the patient's body. When an operator moves the target from one adipose tissue site to a new adipose tissue site, the mechanical properties of the adipose tissue at the new site may differ from previous sites. As such, the therapy parameters for distributing HIFU signals may need to be changed in light of the different mechanical properties. However, known HIFU systems have limited capabilities in identifying the mechanical properties of the target region. In addition, known HIFU systems may not be able to determine if delivered-to-site therapy was effective in at least partially liquefying adipose tissue.

Therefore, there is a need for an ultrasound therapy system that determines mechanical properties of a proposed target region. There is also a need for an ultrasound system that confirms that an effective amount of treatment has been delivered to a site in a patient.

Brief Description Of The Invention

In one embodiment, an ultrasound system is provided that is configured to determine if a patient's adipose tissue has received therapy at a treatment site. The system includes an ultrasound probe and a shear wave generation module to control the probe to provide a shear wave beam that is configured to generate a shear wave at a first site in the patient. The shear wave is configured to propagate through the treatment site toward a second site in the patient. The system also includes a tracking module to control the probe to track the shear wave at the patient's second site to determine if the treatment site has received therapy.

In another embodiment, a method is provided to determine if a patient's adipose tissue has received therapy at a treatment site. The method includes providing a shear wave beam to generate a shear wave at a first site in the patient. The shear wave is configured to propagate through the treatment site toward a second site in the patient. The method also includes tracking the shear wave at the patient's second site to determine if the treatment site has received therapy.

In yet another embodiment, a system is provided for determining whether a patient's adipose tissue has received therapy at a treatment site. The system includes a shear wave generator that is configured to generate a shear wave at a first site in the patient. The shear wave is configured to propagate through the treatment site toward a second site in the patient. The system also includes a tracker that is configured to track the shear wave at the patient's second site to determine if the treatment site has received therapy.

Brief Description Of Drawings

Figure 1 is a schematic diagram of an ultrasound therapy system formed in accordance with one embodiment of the invention.

Figure 2 is a block diagram of an ultrasound system formed in accordance with one embodiment of the invention.

Fig. 3 is a block diagram of a diagnostic module in the ultrasound system of Fig. 2 formed in accordance with an embodiment of the invention.

Fig. 4 is a block diagram of a therapy module in the ultrasound system of Fig. 2 formed in accordance with an embodiment of the invention.

Figure 5 illustrates transducer assemblies that can be used with a probe according to various embodiments.

Figure 6 is a schematic diagram of a probe according to one embodiment of the invention and a region of interest (ROI) in a patient.

Figure 7 is a schematic diagram of the ROI in Figure 6 after therapy has been applied by the probe.

Figure 8 illustrates another method according to one embodiment of the invention.

Figure 9 illustrates another method according to one embodiment of the invention.

Figure 10 illustrates a window presented on a display showing a treatment space for an ROI.

Fig. 11 illustrates another window shown in the display of Fig. 10 showing a treatment space for an ROI.

Figure 12 shows the window in figure 10 as the ultrasound system delivers therapy to the treatment space.

Figure 13 illustrates an ultrasound system according to one embodiment including a tracking system and a recording system.

Fig. 14A is a flow chart illustrating a method according to one embodiment.

Figure 14B is a flow chart illustrating another method according to one embodiment.

Figure 15 illustrates a hand-held or pocket size ultrasound imaging system that can be configured to display a region of interest during a therapy session according to various embodiments.

Figure 16 illustrates a console-based ultrasound imaging system provided on a mobile base that can be configured to display a region of interest during a therapy session according to various embodiments.

Figure 17 is a block diagram of exemplary modes in which embodiments of the invention may be stored, distributed and installed in a computer readable medium.

Detailed Description of the Invention Exemplary embodiments that are described in detail below include ultrasound systems and methods for treating a region of interest (ROI). The ROI may include at least one between adipose and non-adipose tissue, such as a dermis layer, muscle tissue, bone, organ tissue, and blood vessels. The system may also include a display or imaging device that displays ROI so that a system operator or user can distinguish between adipose and non-adipose tissue and / or the system can automatically differentiate between adipose and non-adipose tissue. before treatment. In addition, the display can also indicate those locations on the ROI that have been treated. Treatment of ROI may include the provision of high intensity focused ultrasound (HIFU) signals to ROI treatment sites. When therapy is delivered to a treatment site in adipose tissue, mechanical properties or characteristics of adipose tissue may be affected. For example, HIFU signals may be directed to treatment sites in adipose tissue to at least partially liquefy adipose tissue.

Exemplary embodiments may also include methods and systems for determining if an effective amount of therapy has been received at a treatment site. As an example, a treatment site in a patient's adipose tissue received an "effective amount" of therapy if the adipose tissue at the treatment site was at least partially liquefied for body shaping and / or weight loss purposes.

In addition, methods and systems described herein may be configured to track a shear wave that propagates through a tissue to determine the mechanical properties of the tissue. In specific embodiments, the shear wave is configured to propagate through a treatment site that may or may not have already received therapy. As used herein, a shear wave or waves "propagating through" one site or site may include the shear wave being generated at that site or site or being generated at another adjacent site. More specifically, in some embodiments, therapy may be applied to a treatment site and shear waves may be generated at the treatment site (either subsequent to or during therapy application). Shear waves can be traced elsewhere to determine the mechanical properties of adipose tissue at the treatment site. If the treatment site has received an effective amount of therapy, the shear wave may not be detected at the other site or the shear wave may be substantially affected (ie the waveform characteristics of the shear wave that are detected at other site after therapy are significantly different from the waveform characteristics of the shear wave before therapy).

The following detailed description of certain embodiments will be better understood when read in combination with the accompanying drawings. To the extent that the figures illustrate function block diagrams of various embodiments, the function blocks are not necessarily indicative of the division between hardware circuitry. Thus, for example, one or more function blocks (for example, processors or memories) may be implemented in a single piece of hardware (for example, a general purpose signal processor or random access memory, hard disk, or the like). ). Similarly, programs may be standalone programs, may be incorporated as subroutines in an operating system, may be functions in an installed software package, and the like. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings.

As used herein, an element or step mentioned in the singular and preceded by the word "one" or "one" shall be understood to not exclude plurals of the elements or steps, unless such exclusion is explicitly mentioned. Moreover, references to "one embodiment" are not intended to be construed as excluding the existence of additional embodiments that also incorporate the mentioned features.

Additionally, unless explicitly stated otherwise, embodiments "comprising" or "having" one element or a plurality of elements having a specific property may include such additional elements having no such property.

It should be noted that while various embodiments may be described with respect to an ultrasound system, the methods and systems described herein are not limited to imaging and therapy that are performed exclusively by ultrasound. In particular, various embodiments may be implemented with respect to different types of medical imaging, including, for example, magnetic resonance imaging (MRI) and computed tomography (CT) imaging. In addition, shear waves may be generated by an ultrasound probe or other system or device. In addition, the various embodiments may be implemented in other unmeasured imaging systems, for example non-destructive testing systems such as airport sorting systems.

A technical effect of the various embodiments of the systems and methods described herein includes confirming or determining whether a treatment site in adipose tissue was at least partially liquefied. Another technical effect may include determining mechanical properties of adipose tissue in a target region or treatment site. Another technical effect may include generating an image of an ROI and indicating to a user that an ROI treatment site was at least partially liquefied. Another technical effect may include providing therapy to treatment sites and automatically moving the treatment site between multiple points (or treatment sites) in the treatment. Other technical effects may be provided by the embodiments described herein.

Figure 1 is a diagram of an exemplary ultrasound system 50 formed according to one embodiment. System 50 is configured to treat adipose tissue 52 (or other tissue) in a region of interest (ROI) of a patient and / or to determine mechanical properties of adipose tissue 52 (or other tissue) in ROI. System 50 may include an ultrasound probe 56, a shear wave generator 60, and a tracker 62. Wave 56 is configured to deliver, during a therapy session, therapy to a treatment site 58 in tissue. adipose 52 from ROI. For example, probe 56 may be configured to deliver HIFU signals to treatment site 58. Therapy delivered to treatment site 58 may affect mechanical properties of adipose tissue 52 at treatment site 58. For example, adipose tissue 52 at treatment site Treatment 58 may be lysed by cavitation or heat treatment which results in adipose tissue 52 being at least partially liquefied. Liquefied adipose tissue 52 has different mechanical properties than adipose tissue 52 that has not received therapy. The resulting change, if any, in the mechanical properties at the treatment site 58 may make it easier to determine (a) whether therapy was received by the fatty tissue at the treatment site 58; (b) whether therapy was effective to treat adipose tissue 52; and (c) information regarding the mechanical properties of adipose tissue 52 at the treatment site 58.

System 50 can determine the mechanical properties of treatment site 58 before and after treatment using elastographic methods and particularly using shear waves. Mechanical properties may include at least one of a shear modulus of elasticity, Young modulus, dynamic shear viscosity, and mechanical impedance of the target tissue. Mechanical properties may be calculated or determined using propagation parameters such as a shear wave velocity, a shear wave attenuation coefficient, a tissue particle shear amplitude and velocity in a propagating shear wave, and spatial and temporal dependence of shear amplitude and velocity of tissue particles. Another parameter that can be used is shear viscosity which can be derived from shear rate changes as a function of frequency.

As shown, the treatment site 58 is located substantially between a generation site 66 (also called a first site or shear wave source) and a tracking site 68 (also called a second site). Prior to the generation of a shear wave, tracker 62 may distribute one or more tracking pulses 70 toward tracking site 68. A reflex signal 72 from adipose tissue 52 from tracking site 68 may be indicative of adipose tissue 52 at the second site 68 in a baseline condition (that is, before any shear wave displacement).

Upon obtaining the reflection signal (s) 72 from the second site 68 prior to any displacement, the shear wave generator 60 is configured to distribute a shear wave pulse or pulse 74 toward the first site 66. which is near treatment site 58. Pulse pulse 74 generates a shear wave 64 at first site 66 which propagates toward treatment site 58 (also called the target region) and toward second site 68. The generator Waveform 60 can generate shear wave 64 before therapy is applied to treatment site 58. Tracker 62 is configured to track shear wave 64 at second site 68 by distributing one or more tracking pulses 70 in towards second site 68. when shear wave 64 propagates to second site 68, another reflex signal 72 of tracking pulse 70 is provided. More specifically, tracking pulses 70 are modified by adipose tissue 52 at second site 68 while experiencing shear wave 64. Reflex signal 72 from second site 68 indicates an offset reference condition of adipose tissue 52 at second site 68. Reflection signals 72 of the displaced reference condition and second site baseline condition 68 provide references that can be compared with other conditions of the second site 68.

Upon receiving the reflection signal 72 from the shifted reference condition, probe 56 may deliver therapy (e.g., HIFU signals) to treatment site 58. During or subsequent to treatment, shear wave generator 60 may distribute one or more more shear wave pulses or pulse 74 to first site 66 to generate another shear wave 64. If an effective amount of therapy was received by adipose tissue 52 at treatment site 58, the mechanical properties of adipose tissue 52 at treatment site 58 should substantially affect the propagation of shear wave 64. For example, if treatment site 58 is substantially liquefied, shear wave 64 may not propagate through treatment site 58 or reach second site 68 If the shear wave 64 reaches the second site 68, characteristics of the shear wave 64 (eg velocity and amplitude) may be significant. affected. More specifically, the velocity may be slower and the amplitude may be smaller compared to a shear wave velocity and amplitude 64 when the treatment site 58 has not received therapy.

Pulse pulse 74 and tracking pulse 70 may be distributed at different intensity levels. Pulse pulse 74 may be an intense pulse generating an appreciable radiation force at first site 66. For example, pulse pulse 74 may be a focused ultrasound amplitude modulated beam that provides a radiation force to generate the shear wave 64 at the first site 66. A significant amount of acoustic energy can be distributed to the first site 66 to obtain a desired initial displacement at the first site 66. The localized force that generates the shear wave 64 causes tissue displacement to occur. along the wave path. In some embodiments, shear waves may propagate from a point source. In other embodiments, the shear waves may be virtually extended shear waves along a plane.

The tracker 62 may utilize any imaging technique capable of detecting internal tissue movement in the ROI. For example, tissue shifts at the first, second or any other site may be determined using methods based on ultrasonic correlation or other pattern matching methods. Tracker 62 may utilize any echo-pulsed imaging methods, B-mode imaging methods, and continuous or pulsed Doppler imaging methods. In addition, the tracker 62 may be a magnetic resonance imaging (MRI) system. Optical tracking can also be used to detect internal ROI movement.

Separate components or devices may be used for therapy, imaging, shear wave generation and shear wave detection. Alternatively, a component or device (e.g., a transducer) may be used for any combination (or all) of therapy, imaging, shear wave generation, and detection. Accordingly, as shown in Figure 1, the shear wave generator 60, probe 56, and tracker 62 can all be incorporated into a single device or system, such as system 120 described in detail below. More specifically, the functions of shear wave generator 60 and tracker 62 may be performed by probe 56. However, in alternative embodiments, one or more of shear wave generator 60, probe 56 and tracker 62 operates separately from the other components. For example, shear wave generator 60 and tracker 62 may be separate ultrasound probes. Also, in alternative embodiments, the shear wave generator may be made by a mechanical drive or an audio speaker.

Figure 2 is a block diagram of an exemplary ultrasound therapy system 120 in which various embodiments may provide therapy for and / or display an ROI during a therapy session for treating adipose tissue. Ultrasound system 120 includes a transmitter 122 that drives a set of transducer elements 124 (e.g., piezoelectric crystals) on a probe 126 to emit pulsed ultrasonic signals in a body or volume. Pulsed ultrasonic signals may be for imaging and / or for ROI therapy. Pulsed ultrasonic signals may also be for generating and / or tracking shear waves. For example, probe 126 may distribute low energy pulses during imaging and tracking, medium to high energy pulses to generate shear waves, and high energy pulses during therapy. A variety of array geometries and configurations may be used and the transducer element assembly 124 may be provided as part, for example, of different types of ultrasound probes. Imaging and tracking signals may be scattered reflected in body structures, for example, adipose tissue, muscle tissue, connective tissue, blood cells, veins, or objects in the body (eg, a catheter or needle) to produce echoes that return to elements 124. Echoes are received by a receiver 128. Received echoes are provided to a beamformer 130 which performs beam formation and transmits an RF signal. The RF signal is then supplied to an RF processor 132 which processes the RF signal. Alternatively, RF processor 132 may include a complex demodulator (not shown) that demodulates the RF signal to form representative IQ data pairs of echo signals. The RF or IQ signal data may then be supplied directly to a memory 134 for storage (e.g., temporary storage). Optionally, the output of beamformer 130 may be passed directly to diagnostic module 136.

The ultrasound system 120 also includes a processor or diagnostic module 136 for processing the acquired ultrasound information (e.g., RF signal data or IQ data pairs) and preparing ultrasound information tables for display on a display 138. diagnostic module 136 is adapted to perform one or more processing operations according to a plurality of ultrasound modalities selectable from the acquired ultrasound information. Acquired ultrasound information can be processed in real time during a scan or therapy session as echo signals are received.

Additionally or alternatively, the ultrasound information may be temporarily stored in memory 134 during a scan session and processed in less than real time in live or offline operation. An image memory 140 is included to store processed frames of acquired ultrasound information that are not scheduled to be displayed immediately. Image memory 140 may comprise any known data storage medium, for example a permanent storage medium, removable storage medium, etc.

Diagnostic module 136 is connected to a user interface 142 which controls operation of diagnostic module 136, as explained below in more detail, and is configured to receive input from a user. Display 138 includes one or more monitors displaying patient information, including user diagnostic and therapeutic ultrasound images for examination, diagnosis, analysis, and treatment. Display 138 can automatically display, for example, a 2D, 3D, or 4D ultrasound dataset stored in or currently being acquired in memory 134 or 140, the dataset of which is also displayed with a graphical representation (for example, a sketch of a treatment space or a marker in the treatment space). One or both memory 134 and memory 140 may store 3D data sets of ultrasound data, where such 3D data sets are accessed to display 2D and 3D images. For example, a 3D ultrasound data set may be mapped to corresponding memory 134 or 140, as well as one or more reference planes. Data processing, including data sets, may be based in part on user inputs, for example, user selections received in the user interface 142.

Diagnostic module 136 is configured to analyze ultrasound signals to image ROI and / or track shear waves that propagate across ROI. In addition, diagnostic module 136 may also automatically differentiate adipose tissue from non-adipose tissue (e.g., muscle tissue, bone, connective tissue, organs). Diagnostic module 136 may also be configured to receive user imaging commands to delineate or otherwise provide an overlay indicating a treatment space in the ROI. Diagnostic module 136 may also receive user therapy commands (for example, via user interface 142) regarding how to apply therapy to treatment sites on the ROI. Therapy commands may refer to therapy parameters and the like.

Diagnostic module 136 communicates with a therapy module 125 that is configured to control probe 136 during a therapy session. A "therapy session" as used herein is a period of time in which a patient receives therapy. For example, a therapy session may include a single application of ultrasound signals to liquefy adipose tissue at a single treatment site or in a single treatment space on the body. A therapy session may also include an extended period of time in which a patient receives multiple applications of ultrasound signals in a treatment space of one body region or multiple body regions. A therapy session may also include a patient visit to a system operator 120.

Diagnostic module 136 may be configured to control probe 126 to deliver and obtain diagnostic ultrasound signals from ROI and to control probe 126 to distribute a pulse pulse to generate a shear wave at ROI. Therapy module 126 is configured to deliver therapy to ROI-based treatment sites. Therapy module 125 can automatically move the treatment site between multiple points based on user inputs.

In operation, system 120 acquires data, for example volumetric data sets by various techniques (eg, 3D scanning, real-time 3D imaging, volume scanning, 2D scanning with transducers having positioning sensors, freehand scanning using a voxel correlation technique, 2D scanning or array array transducers, etc.) - Data can be acquired by moving probe 126, such as along a linear or curvilinear trajectory, while scanning the ROI. In each arcuate or linear position, probe 126 obtains scan planes that are stored in memory 134. Probe 126 can also be mechanically movable on the ultrasound probe.

System 120 also includes a shear wave generation module 123 that is operably coupled to diagnostic module 136 or a sub module of diagnostic module 136. Shear wave generation module 123 is configured to control probe 126 to generate a shear wave at a site on the patient's ROI. Shear wave generation module 123 may control probe 126 or, more particularly, transducer elements 124 to orient a pulse pulse (s) or shear wave generation toward the predetermined site to generate the shear wave. . Alternatively, the shear wave generating module 123 may control another device capable of generating shear waves. For example, the shear wave generating module 123 may control a therapy transducer, a mechanical driver, or an audio device for generating the shear waves. The pulse pulse (s) may be configured to generate a desired shear wave and orient the shear wave along a desired direction or trajectory.

Optionally, system 120 may include a position tracking module 148 which tracks a position of probe 126 and communicates the position to diagnostic module 136. A position of probe 126 may be tracked relative to a reference point at or near the patient, a marker and the like. As will be described in more detail below, the position of the probe 126 may be used to indicate to the user which patient regions have been treated, are being treated or have yet to be treated.

Figure 3 is an exemplary block diagram of diagnostic module 136, and Figure 4 is an exemplary block diagram of therapy module 125. Therapy and diagnostic modules 125 (figure 4) and 136 (figure 3) are illustrated. conceptually as a collection of modules, but can be implemented using any combination of dedicated hardware panels, DSPs, processors, etc. Alternatively, the modules of Figures 3 and 4 may be implemented using a single-processor or multi-processor off-the-shelf PC, with functional operations distributed among the processors. As an additional option, the modules of figures 3 and 4 may be implemented using a hybrid configuration in which certain modular functions are performed using dedicated hardware, while the remaining modular functions are performed using a retail PC and the like. Modules can also be implemented as software modules in a processing unit. In addition, diagnostic module 136 may include therapy module 125, or therapy module 125 may include diagnostic module 136.

The operations of the modules illustrated in figures 3 and 4 can be controlled by a local ultrasound controller 150 or diagnostic module 136. Modules 152-166 perform medium processor operations. Diagnostic module 136 can receive ultrasound data 170 in one of several ways. In the embodiment of Figure 3, the received ultrasound data 170 constitutes pairs of IQ data representing the real and imaginary components associated with each data sample. IQ data pairs are provided to one or more modules, for example, a color flow module 152, an acoustic radiation force imaging (ARFI) module 154, a B-mode module 156, a Doppler spectral module 158 , an acoustic streaming module 160, a tissue Doppler module 162, a tracking module 164, and an elastography module 166. Other modules may be included, such as an M-mode module, power Doppler module, among others. . However, the embodiments described herein are not limited to processing IQ data pairs. For example, processing may be done with RF data and / or using other methods. In addition, data can be processed through multiple modules.

Each of modules 152-166 is configured to process the IQ data pairs in a corresponding mode to generate, respectively, color flow data 172, ARFI data 174, B mode data 176, spectral Doppler data 178, streaming data 180, Tissue Doppler Data 182, Tracking Data 184, Elastography Data 186, among others, all of which may be stored temporarily in Memory 190 (or Memory 134 or Image Memory 140 shown in Figure 2) prior to subsequent processing. . Data 172-186 may be stored, for example, as sets of vector data values, where each set defines an individual ultrasound image frame. Vector data values are generically organized based on the polar coordinate system.

A raster converter module 192 accesses and retrieves from memory 190 the vector data values associated with an image frame and converts the set of vector data values to Cartesian coordinates to generate an ultrasound image frame 193 formatted for. exhibition. The ultrasound image frames 193 generated by the raster converter module 192 may be supplied back to memory 190 for further processing or may be supplied to memory 134 (figure 2) or image memory 140 (figure 2). After the raster converter module 192 generates the associated ultrasound image frames 193, the image frames may be retrieved in memory 190 or communicated via a bus 199 to a database (not shown), the memory 134, image memory 140 and / or to other processors (not shown).

As an example, you may want to view the different ultrasound images for a real-time therapy session on the display 138 (figure 2). To do this, scan converter module 192 obtains data sets for images stored in memory 190 from those currently being purchased. Vector data is interpolated where necessary and converted to an X, Y format for video display to produce ultrasound image frames. Scan-converted ultrasound image frames are provided to a viewfinder controller (not shown) that can include a video processor that maps the video in a Gray scale to video viewer mapping. The gray scale map can represent a function of transferring raw image data to displayed gray levels. After video data has been mapped to Gray scale values, the display controller controls display 138, which may include one or more display monitors or windows, to display the image frame. The display image 138 is produced from a data image frame in which each data indicates the intensity or brightness of a respective pixel in the display.

Referring again to Figure 3, a 2D video processor module 194 may be used to combine one or more of the generated frames of different types of ultrasound information. For example, the 2D video processor module 194 can combine different image frames by mapping one data type to a gray map and mapping the other data type to a video display color map. In the final displayed image, the color pixel data is overlaid on the gray scale pixel data to form a single multi-mode image frame that is either retrieved into memory 190 or communicated via bus 199. Successive frames of images may be be stored as a cine loop (4D images) in memory 190 or memory 140 (figure 2). Cine Ioop represents a first-in, first-out circular image buffer to capture image data that is displayed in real time to the user. The user can freeze cine Ioop by entering a freeze command on user interface 142. User interface 142 can include, for example, a keyboard and mouse and all other input controls associated with entering information into the ultra system. 120 (figure 2). In one embodiment, user interface 142 includes display 138 which may be touch sensitive or configured to interact with a pen. User interface 142 may also receive user inputs through voice recognition or activation.

A 3D processor module 196 is also controlled by user interface 142 and accesses memory 190 to obtain spatially consecutive groups of ultrasound image frames and generate three-dimensional image representations thereof, such as through volume rendering or rendering algorithms. surface as they are known. Three-dimensional images can be generated using various imaging techniques such as lightning, maximum intensity pixel projection and the like.

A graphics module 197 may also be controlled by system 120 and may access memory 190 for groups of ultrasound image frames that have been stored or are currently being purchased. Graphics module 197 can generate images that include ROI images and a graphical representation positioned (for example, overlapping) on ROI images. The graphical representation may represent an outline of a treatment space, the focal point or region of the therapy beam, a trajectory taken by the focal region in the treatment space, a probe used during the session, and the like. Graphical representations can also be used to indicate the progress of the therapy session. Graphic representations can be generated using a saved graphic image or drawing (for example, switch graphic generated drawing) or the graphic representation can be directly drawn by the user over the image using an indicating device, such as a mouse or pen. electronics or other interface device.

Also shown, a reference module 195 may be used to identify a reference point at or near the patient during the therapy session. For example, a reference point may be a body structure or anatomical element that is determined by system 120 or the user. The reference point may also be an element or marker positioned on the patient's body surface. As will be described in more detail below, the reference module 195 may use the imaging data to determine a treatment space relationship to a reference point.

Referring to Figure 4, Therapy Module 125 may be coupled to Diagnostic Module 136 (Figure 2) and User Interface 142 (Figure 2) and includes a Transmission Beam Module 127 and a Transmission Module 129 Transmission beam forming module 127 is configured to control the location and movement of a focal point or region generated by transducer elements 124. for example, transmission beam forming module 127 can control mechanical or electronic direction of the probe. to move the focal region of a therapy beam into treatment spaces or between different treatment spaces. Transmission module 129 is configured to drive transducer elements 124 (or only a portion or subset of transducer elements 124) in the distribution of energy pulses to the ROI for imaging and therapy.

Figure 5 illustrates transducers 410, 420 and 430 that can be used with a probe (not shown) according to various embodiments.

Transducers 410, 420 and 430 may include reconfigurable assemblies. In some embodiments, diagnostic module 136 (FIG. 2) controls probe 126 (FIG. 2) to distribute imaging and / or tracking pulses, shear wave generation module 123 (FIG. 2) controls probe to generate a shear wave, and therapy module 125 (figure 2) controls the probe to generate therapy pulses. In relation to each other, tracking and imaging pulses may be low energy, shear wave generation pulses may be medium to high energy, and therapy pulses may be high energy.

Transducer 410 has an imaging set 412 and a separate therapy set 414 surrounding the imaging set 412. Imaging set 412 and therapy set 414 may be in a fixed relationship to each other. Imaging pulses and therapy pulses may be distributed separately or in an interleaved or overlapping mode. In some embodiments, low energy imaging pulses and shear wave pulses may also be transmitted by therapy set 414. Reflections of these low energy imaging pulses may be received by imaging set 412 to form an image of the focal region of therapy set 414 or track a shear wave. Embodiments of a dual therapy and imaging system are described in more detail in US Patent No. 5,769,790, which is incorporated by reference in its entirety.

Transducer 420 includes a set 422 where the full set can be used for imaging, tracking and therapy. However, transducer 430 has a set 432 of transducer elements where a therapy portion 434 of set 432 may be activated to provide therapy. As such, therapy module 125 may drive a subset (e.g., therapy portion 434) of transducer elements of assembly 432 based on user inputs designating the treatment space. Although not shown, transducer 430 may also have tracking portion of assembly 432 which includes a subset of transducer elements for tracking shear waves. The therapy portion, tracking portion, and imaging portion may share transducer elements. Thereby, diagnostic module 136 and therapy module 125 may distribute low energy imaging and / or tracking pulses and high energy therapy pulses, respectively, in an interleaved mode with at least a partially overlapping set of transducer elements. .

When imaging or delivering therapy to a patient, the pressure applied by the transducer to the patient's body may alter the thickness or other characteristics of ROI1 such as tissue stiffness. By combining the tracking, therapy, and imaging sets into one transducer, therapy can be applied immediately after the transducer imagines ROI and the shear wave can be generated immediately after and before. As such, an accurate representation or identification of adipose tissue may be provided immediately before therapy is applied. However, in alternative embodiments, separate transducers may be used for therapy, imaging and / or screening.

Figures 6-9 are schematic diagrams illustrating an ultrasonic probe 500 or methods configured to deliver therapy to a treatment site and confirm whether an amount of therapy received at the treatment site was sufficient to remove or liquefy adipose tissue. In addition, or alternatively, ultrasonic probe 500 may be used to determine mechanical properties of adipose tissue near the treatment site.

Figure 6 illustrates probe 500 having a transducer 502 with a set 504 of transducer elements. As shown, transducer 502 is located on a skin surface 506 in a patient's ROI. ROI includes adipose tissue at a depth below surface 506. In some embodiments, probe 500 may distribute tracking pulses 522 to a tracking site or second site 514 to receive reflex signals 524 indicative of a baseline condition of the adipose tissue. Also, before therapy is applied to a treatment site, the probe may generate shear waves 520 at a first generation site or site 512 to determine a displaced reference condition of adipose tissue at the second site 514. the first and second sites 512 and 514 may be separated by a distance Dt. Transducer 502 may deliver a beam or pulse 516 of focused ultrasound signals to a predetermined spatial volume at first site 512 to generate shear waves 520. The force of radiation resulting at first site 512 generates shear waves 520A and 520B that propagate away from first site 512 in opposite directions that are substantially parallel to a surface of transducer 502. In addition, since the propagation of shear waves 520A and 520B are directly related to the mechanical properties of adipose tissue in ROI, the distance Dr can be configured so that the waves of and shear 520 are capable of crossing the DT distance without being fully attenuated.

Although Figure 6 shows only shear waves 520A and 520B moving perpendicular to one beam direction, many shear waves can be generated at first site 512 that propagate away from the first site in multiple directions. The shear waves may be diverging spherically, diverging from a plane, or diverging in some other configuration. Also, in some embodiments, multiple pulse pulses may be used to create a shear wave directed in a specific direction. Such shear waves can be generated using methods similar to those used in supersonic shear wave imaging.

After distributing beam 516 to generate shear waves 520, transducer 502 can distribute a series of tracking pulses 522 toward second site 514. When shear wave 520A propagates through second site 514, reflected signals 524 are from the baseline condition by the shear wave 520A. Reflected signals 524 from the tracking pulse series 522 represent various levels of adipose tissue displacement as shear wave 520A or waves 520A pass through the second site 514. A relative movement of adipose tissue at the second site 514 can be determined using correlations between the reflected signals 524 of the second site 514 in the baseline condition and shifted conditions. For example, a shift as a function of time for adipose tissue at the second site 514 can be determined.

Accordingly, shear wave reference characteristics 520A can be determined. These reference characteristics can be further compared with shear wave characteristics that propagate through treated adipose tissue.

More specifically, the displaced and baseline conditions of the second site 514 may facilitate the determination of mechanical properties of adipose tissue in the region between the first and second sites 512 and 514. In addition, the displaced and baseline conditions may facilitate determining whether therapy was received by a treatment site located between the first and second sites 512 and 514. Also, a time to propagate the distance Dj can be calculated by measuring the time between shear wave generation and detection of shear wave.

Figure 7 illustrates probe 500 at a time after therapy has been delivered to a treatment site 530. After therapy has been delivered, transducer 502 can deliver beam 516 to first site 512 to generate more shear waves 521. The shear wave 521A may be directed to propagate toward the second site 514 and the shear wave 521B propagates in the opposite direction. When shear wave 521A propagates through treatment site 530, the mechanical properties of adipose tissue at treatment site 530 may affect the propagation of shear wave 521A. In particular, if therapy received at the treatment site 530 has at least partially liquefied the adipose tissue, the propagation of the shear wave 521A may be significantly affected.

Reflected signals 524 may indicate characteristics of the shear wave 521A that are different from the characteristics of the shear wave 520A (Figure 6) at the second site 514. For example, at least one of the shear wave velocity, the amplitude of the shear, shear wave viscosity, and shear wave frequency may be noticeably different at the second site 514 (ie, values or data from the reflected signals before and after treatment may be significantly different indicating a change in mechanical properties). In addition, in some instances, the shear wave 521A may not reach the second site 514 or may not propagate through the treatment site 530 within a predetermined period of time. For example, the shear wave 520 may not propagate through the second site 514 at a predetermined time period that is greater than the calculated time period for a shear wave to propagate the DT distance prior to treatment.

Figure 8 illustrates another method for confirming that therapy was received at a treatment site. When therapy is delivered to a treatment site 542, shear waves 544 may be generated from the treatment site 542 and propagate in one direction to a tracking site 546. In some embodiments, the therapy system (not shown) may use shear waves 544 generated at treatment site 542 to determine the effectiveness of therapy applied to other treatment sites. More specifically, as shown, a treatment site 548 may be located substantially between treatment site 542 and screening site 546. treatment site 548 receives therapy prior to treatment site 542. When therapy is subsequently distributed to the treatment site 542, shear waves 544 may propagate toward treatment site 548. Mechanical properties of adipose tissue at treatment site 548 may affect wave propagation of shear waves 544, as described above. Therefore, screening site 546 may be screened after therapy is applied to treatment site 542 to determine if ablation of adipose tissue at the site. treatment 548 was effective.

Alternatively, shear waves 544 generated at treatment site 548 may be traced to determine characteristics or mechanical properties of adipose tissue near treatment site 548.

Figure 9 illustrates another method for confirming that therapy was received at a treatment site. In some embodiments, shear waves that are configured to be generated at the treatment site may be detected. For example, Figure 9 shows a treatment site 550 and a first generation site or site 552. A first shear wave generating beam may be directed to treatment site 550 before therapy is applied to the treatment site. 550. The first shear wave generating beam generates shear waves 554 at first site 552 that at least partially overlap the intended treatment site 550. Shear waves 554 can be detected at an adjacent tracking site 556. Waves Detected shear strips 554, before therapy is applied to treatment site 550, provide a baseline or initial tissue condition at screening site 556. Subsequently, a therapy beam may be delivered to treatment site 550 A second shear wave generating beam may then be directed to the treatment site 550. if the treatment site 550 had received a For effective therapy, shear waves 554 will not be detected at screening site 556 or will be significantly weaker and / or slower.

As shown in Figure 9, in some embodiments, dimensions of the treatment site 550 (i.e. an area or volume in adipose tissue) may be larger than the dimensions of the first site 552 (i.e. dimensions of the generation pulse created by the shear wave generation beam). More specifically, a focal region of the therapy beam may be larger than a focal region of the shear wave generating beam. As an example, if the shear wave beam has a higher frequency, such as a harmonic, a narrower shear wave beam may be formed such that the generation site 552 lies within the treatment site. 550, as shown in Figure 9. In other embodiments, the shear wave generating beam may have a focal region that is larger than the focal region of the therapy beam such that the first site (indicated by 552 ') is larger than the treatment site 550.

In other embodiments, shear waves may be used to determine a size, shape or composition of the treatment site after therapy has been delivered. For example, shear waves may be separately generated at multiple generation sites on one side of the treatment site along a vertical geometric axis. Shear waves can be detected at their tracking sites along the vertical geometric axis on the other side of the treatment site. At the center of the treatment site, adipose tissue may be most affected by therapy and any shear waves would not be able to propagate through it. However, at one periphery of the treatment site, shear waves may pass through with some additional attenuation. These more attenuating shear waves indicate areas of the treatment site that have effectively received the most therapy.

Accordingly, a size, shape and composition of the treatment site may be determined. Alternatively, shear waves may be generated at the treatment site as discussed above, and shear waves may be detected to determine the mechanical properties of the tissue at the treatment site.

Fig. 10 illustrates a window 100 which may be shown on display 138 (fig. 2). Display 138 communicates with diagnostic module 136 (Figure 2) to display a patient ROI image 102 in window 100. As shown in image 102, ROI may include adipose tissues or layers 104 and 106 and tissues or layers non-fat, such as the dermis layer 109 or connective tissue 108, and muscle tissue 110. The ROI image 102 may also include other anatomical structures such as bone, organs, cartilage, and others. As will be discussed in more detail, system 120 may be able to automatically identify or differentiate between layers. After differentiating adipose tissue 104 from other tissues, system 120 can deliver therapy pulses (e.g., HIFU) to treatment sites in adipose tissue 104. system 120 can also confirm that an effective amount of therapy has been received at the treatment sites. treatment using, for example, the shear wave methods described above. Alternatively, the user of the system 120 may be able to recognize or identify through the image 102 the different tissue layers and designate certain places to receive therapy. The user may also be able to visually identify whether the therapy was effective or not.

To automatically differentiate adipose tissue 104, 106 from non-adipose tissue, and more specifically dermis layer 109, connective tissue 108, and muscle tissue 110, diagnostic module 136 can analyze ultrasound signals received from ROI. For example, diagnostic module 136 may use data obtained by one or more processing methods (e.g., B-mode, elastography, color flow). In some embodiments, diagnostic module 136 automatically differentiates adipose tissue 104 from non-adipose tissues by at least identifying barriers or boundaries 112 and 114 (indicated as dashed lines) between adipose tissues 104 and 106 and / or adjacent non-adipose tissue such as dermis layer 109 and muscle tissue 110. for example, diagnostic module 136 may identify connective tissue 108 extending between adipose tissues 104 and 106. system 120 (figure 2) may use stored information regarding human anatomy It is general in the ROI to identify a location of the adipose tissue 104 relative to the limit 112 (i.e. the connective tissue 108 shown in Figure 10). More specifically, system 120 may identify adipose tissue 104 as the tissue or layer extending directly underneath the connective tissue 108. optionally, system 120 may indicate to the operator the different layers and tissues in ROI by illustrating graphical representations of barriers or boundaries 112 and 114, such as overlapping dashed lines over image 102 as shown in figure 10.

System 120 can automatically differentiate fabrics in ROI using other methods separately or in combination with identification boundaries or barriers. As another example, diagnostic module 136 can automatically differentiate adipose tissue 104 and 106 from other tissues by at least directly measuring a plurality of points on the ROI for an adipose characteristic. The fat characteristic may include a measurement of the mechanical properties of the tissue at one or more points, such as stiffness of a tissue, a shear wave velocity between points, a longitudinal wave velocity between points, and a tissue density at one or more points. points. The fat characteristic may also refer to thermal properties. Another adipose feature may be cavitation induction capability on the condition that non-adipose tissue would not be damaged under the conditions that produced adipose tissue cavitation.

In addition to identifying adipose tissue 104 and 106 by measuring adipose characteristics, diagnostic module 136 can identify other unmeasured tissues relative to non-adipose characteristics. For example, diagnostic module 136 can identify connective tissue 108 and muscle tissue 110 by measuring mechanical properties of tissue at one or more points in ROI, such as tissue stiffness, point-to-shear wave velocity, longitudinal wave velocity. between stitches, and a tissue density at one or more stitches. The non-fatty characteristic may also refer to thermal properties. In addition, techniques described above may be used to examine patterns in the image that are characteristic of different tissue types (e.g., muscle tissue, connective tissue, bone tissue). For example, a layered appearance feature of muscle tissue may be determined, or a cellular structure of adipose tissue caused by connective tissue boundaries may be determined.

As a more specific example, in some embodiments, diagnostic module 136 may analyze images obtained by B-mode processing. A B-mode image is a grayscale or color image showing a cross section of ROI along a scanning plane. B-mode imaging refers to the acoustic reflected scattering energy of different tissues in ROI. Figure 10 illustrates a B-mode Gray scale image of ROI. As shown, different fabrics may have different brightness levels. Diagnostic module 136 can measure a brightness level of a plurality of dots in image 102 to differentiate adipose tissue 104 from other tissues. In addition, diagnostic module 136 can use stored information, such as the expected anatomical structures for a specific ROI, as well as the measured brightness levels to determine adipose tissue 104. As an example, if the ROI is from the abdomen, the diagnostic module 136 can expect image 102 to include dermis layer 109 and adipose tissues 104 and 106 separated by connective tissue 108.

In addition, system 120 may utilize elastography processing methods individually or in addition to other processing methods to differentiate adipose tissue 104 and 106. In one type of ultrasound elastography, compression is applied to the ROI (e.g., across the skin surface) and tissue tension images in response to compression can be obtained. For example, spot tracking techniques may use data obtained before and after applied compression to calculate the relative movement of different tissue types due to their different mechanical properties (eg, tissue tension or stiffness). As such, images obtained through elastography, also called elastograms, refer to the elastic properties of tissues. In addition, other techniques may be used to examine the mechanical properties of different fabrics. Other elastography techniques such as inducing and measuring shear waves as described above or vibro-acoustography may be used to differentiate adipose tissue from other tissue types.

In some embodiments, after the initial scan for diagnostic ultrasound signals has been performed and adipose tissues 104 and 106 have been identified, diagnostic module 136 may automatically set a therapy parameter before therapy is applied to the ultrasound. ROI For example, diagnostic module 136 may identify a thickness of one layer of adipose tissue 104. Based on the thickness of adipose tissue 104 and / or other factors, diagnostic module 136 may automatically define a focal region depth, a size focal region, an ablation time for each point in the receiving therapy ROI, a therapy signal energy level, and a focal region movement rate on the ROI during the therapy session. Other parameters can be automatically set, including a negative peak pressure, a pulse repetition rate, a charge cycle, a dwell time, and pulse sequences. In addition, if the thickness, depth or density of the adipose tissue layer 104 decreases or increases as the adipose tissue 104 extends laterally across the ROI (e.g., through image 102), the therapy parameters may change according to the thickness, density, or depth of the layer as therapy is applied. For example, if the thickness is decreasing, then the size of the focal region may also decrease or the energy level of the therapy signals may decrease as therapy moves along adipose tissue 104.

After or while therapy is applied to ROI, diagnostic module 136 can analyze ultrasound signals from a second supplementary scan to confirm ROI treatment. For example, diagnostic module 136 may obtain images from the second scan that include data processed by elastography methods, such as the shear wave methods described above. After or while adipose tissue 104 receives therapy, images obtained by elastography may indicate a change in tissue stiffness at a site that has received or is receiving therapy. More specifically, an initial image may have a color, brightness or density that indicates a tissue stiffness of adipose tissue 104 prior to treatment. In the second supplementary scan, the color, brightness, or density of adipose tissue 104 may change where adipose tissue 104 has received therapy. Images from initial and supplemental scans can be used by system 120 to confirm that treatment has been received on adipose tissue 104. for example, images from initial and supplemental scans may be overlapped with each other or shown side by side on the display 138. Operator can confirm which treatment was received on adipose tissue 104 by comparing images.

In addition, or alternatively, diagnostic module 136 may use other processing methods to facilitate the determination of whether a feature of adipose tissue 104 or other tissue has been changed due to therapy. In addition, after assessing ROI on the second supplementary scan, therapy parameters can be adjusted if therapy should be re-applied to ROI or if the focal region moves elsewhere on the ROI.

Figures 11 and 12 also illustrate features of system 120 that may be used by an operator during a therapy session to facilitate delivery of therapy to ROI. Fig. 11 illustrates a window 202 which may be shown on display 138 (fig. 2). As shown in an image 204, ROI includes adipose tissue 206 and 208 and non-adipose tissue such as dermis layer 209, muscle tissue 210 and connective tissue 211. In some embodiments, system 120 automatically designates a treatment space 212 or User Interface 142 (Figure 2) accepts user inputs to designate treatment space 212 in the ROI. Treatment space 212 represents a space that will be treated during a therapy session and is generally located in an adipose tissue such as adipose tissue 206. Designated treatment space 212 may correspond to a portion of adipose tissue 206 in image 204 or treatment space 212 can correspond to all fat tissue 206 in ROI. As an example, treatment space 212 may be located and shaped such that treatment space 212 is at a distance from non-adipose tissues 211 and 210. As such, a probability of therapy is inadvertently applied to spaces outside the treatment space. 212, such as non-fat tissues 211 and 210, may be decreased.

Display 138 may indicate to the user or another person viewing (for example, the patient) the treatment space 212 designated by the user entries. A graphic representation, such as a sketch 214, may be superimposed on picture 204. sketch 214 designates boundaries of treatment space 212 to indicate to a person seeing where therapy will be applied. Sketch 214 can be determined by user-entered parameters. For example, the user may select preprogrammed sketches 214 or may enter coordinates or dimensions for treatment space 212 to form sketch 214. sketch 214 may indicate a region enclosed in treatment space 212. sketch 214 may have multiple formats including a round rectangular shape (as shown), a parallelogram shape, another geometric shape, and the like or a system-determined shape 120.

You can also enter a drawing notation to indicate where sketch 214 should be located. Drawing notation can be entered via a keyboard, mouse, or other indicating device. As an example, the user may use a pen and directly contact a display touch screen 138 or a pad that is communicatively coupled with the user interface 142 to draw the drawing notation on image 204. as another For example, user interface 142 may recognize finger touches on the display screen 138. In addition, user interface 142 may have a voice activation module that receives voice commands from the user to enter user inputs including the drawing notation.

Sketch 214 can be positioned relative to reference points 250, 252, and 254. Reference module 195 (Figure 3) can be configured to automatically identify reference points 250, 252, or 254 on the patient or to receive user inputs that identify the reference points. For example, reference point 250 may be a patient's skin surface or dermis layer 209, reference point 252 may be a specific point of or a portion of a boundary between adipose tissues 206 and 208, and the reference point 254 may be a point along a surface of probe 126. (For illustrative purposes, reference point 254 and probe 216 are shown in Figure 11. However, reference point 254 and 216 may be shown. or not for the person you see in picture 204.) Landmarks can also be other points in ROI, such as bone, other artifacts, or a reference element such as a metallic patch placed on a patient's skin.

After identifying a reference point, reference module 195 can determine a ratio of treatment space 212 to the identified reference point using ultrasound signal processing methods (e.g., spot tracking). Reference module 195 may position sketch 214 of treatment space 212 in image 204 based on the ratio of treatment space 212 to the identified reference point. As a more specific example, reference module 195 may establish a positional relationship between adipose tissue 206 and reference point 254 representing a probe surface 126.

Based on the positional relationship, the reference module 195 may adjust a position of the treatment space 212 in picture 204. in other words, as the probe 126 moves along the skin surface or is pressed into the patient, sketch 214 in image 204 may move as well.

In addition, reference module 195 may use data collected or determined by diagnostic module 136 (Figure 2) to determine where to place treatment space 212 in the ROI. For example, reference module 195 may use information or data with respect to the tissue characterization discussed above. More specifically, reference module 195 may utilize the plurality of points in ROI that have been analyzed for fat or non-fat characteristics. Using this data, reference module 195 can automatically locate or determine the position of treatment space 212 on the ROI. In some embodiments, diagnostic module 136 may be configured to acquire diagnostic ultrasound signals at different frame rates. A frame rate is the number of frames or images taken per second. More specifically, diagnostic module 136 may be configured to acquire diagnostic ultrasound signals associated with different imaging spaces in ROI at different frame rates. For example, signals from treatment space 212 may be acquired at one frame rate while signals from other spaces outside treatment space 212 may be acquired at another frame rate. In one embodiment, the diagnostic module 136 is configured to acquire diagnostic ultrasound signals at a first rate in an imaging space that includes treatment space 212 and at a second slower rate in an imaging space that excludes treatment space 212. Alternatively, the first rate may be slower than the second rate.

Figure 12 shows window 212 as system 120 (figure 2) delivers therapy to treatment space 212. When therapy is applied, ultrasonic therapy signals (e.g., HIFU) from probe 126 (figure 2) are directed to a treatment site 222 (indicated as points 222A and 222B in Figure 12) in treatment space 212. A treatment site 222 includes a region where a therapy beam 224 is formed by ultrasound signals from of the transducer elements 124 is focused (e.g., a focal region of the transducer elements 124) in a patient's body. Therapy beam 224 is shaped and directed by a selected configuration and operation of transducer elements 124. As such, the focal region of therapy beam 224 and consequently, treatment site 222 may vary in size and shape in a therapy session. only. When adipose tissue 206 is treated, the therapy beam 224 which is delivered to the treatment site 222 is at least partially liquefy (e.g., through lysis, thermal damage, and / or cavitation) adipose tissue 206 in the focal region.

Therapy module 125 (Figure 2) is configured to move treatment site 222 throughout the treatment space 212 between multiple treatment points or sites. As used herein, "moving the treatment site between multiple points" includes moving the treatment site 222 along a therapy path 228 between a first point and an endpoint and also includes moving the treatment site 222 to separate points and in the treatment space 212 which may or may not be adjacent to one another along a path. The therapy path 228 may be formed of separate points where therapy is applied. For example, therapy may first be applied to a first point (indicated as treatment site 222A). After application of therapy to the first point, the focal region may be readjusted to a second point along the therapy path 228 which is separated and remotely spaced from the first point. Therapy can then be applied to the second point. The process may continue along the therapy path 228 until the therapy session is completed at an end point (indicated as the 222B treatment site). In other embodiments, therapy may be continuously applied as the focal region is moved along the therapy path 228 in a scan mode. For example, therapy may be continuously applied as treatment site 222 is moved between the first point and the end point in Figure 12.

In addition, therapy module 125 may operate in combination with shear wave generation module 123 and diagnostic module 136 to confirm that each treatment site 222 receives an effective amount of therapy. System 120 may utilize the shear wave methods described above. For example, upon application of therapy to a first treatment site, the shear wave generating module 123 may automatically generate a shear wave at a generation site near one side of the first treatment site. The diagnostic module can then automatically scan a screening site located on the other side of the first treatment site to determine if the treatment site has received an effective amount of treatment. If the treatment site has received an effective amount of treatment, system 120 can then automatically move to a second treatment site.

The therapy path 228 may be of various shapes and may be preprogrammed or alternatively drawn by the user. As shown in Fig. 12, therapy module 125 may direct treatment site 222 in a scan mode into treatment space 212. More specifically, treatment site 222 may move from a first lateral site 230 near one side of the treatment site. image 204 or outline 214 to a second side location 232 which is near an opposite side of image 204 or outline 214. treatment site 222 may maintain a predetermined depth in adipose tissue 206 as treatment site 222 moves between first and second side sites 230 and 232. In some embodiments, after the treatment site 222 is moved from the first side site 230 to the second side site 232, the depth of the treatment site 222 may be increased or decreased. As shown in Figure 12, the treatment site 22 moves back and forth between the first and second side sites 230 and 232 and increases a depth of the treatment site 222 after each crossing of the treatment space 212. As such, portions of adipose tissue 206 may avoid undergoing multiple therapy periods. Alternatively, the depth of the treatment site 222 may gradually change as the treatment site 222 is moved in a sweep mode. As an example, the depth of the treatment site 222 in adipose tissue 206 may move parallel to a boundary 236 (indicated as a dashed line) between adipose tissues 206 and 208. boundary 236 may or may not be shown to the viewer. .

However, the therapy path 228 shown in Figure 12 is just an example of multi-point therapy application in treatment space 212. Many other therapy paths can be taken by treatment site 222. For example, therapy module 125 may direct the treatment site 222 in a scan mode between two vertical sites while changing a lateral position in the treatment space 212 after the vertical sites have been traversed. In addition, the treatment site 222 is not required to move between adjacent points along the therapy path 228, but may be moved to predetermined or random points in the treatment space 212 that are not adjacent to each other. For example, therapy may be applied to one corner of a treatment space 212. Subsequently, the focal region may then be readjusted to another corner and therapy may be applied.

As described above, therapy delivery may be based on a therapy parameter. A therapy parameter includes any factor or value that can be determined by system 120 or any user-entered input that affects therapy applied to ROI. For example, a therapy parameter may include a transducer parameter that refers to the configuration or operation of transducer elements 124 or probe 126. Other examples of a transducer parameter include a focal region depth, a focal region size, a ablation time for each point in therapy receiving ROI, a therapy signal energy level, and a focal region movement rate on the ROI during the therapy session. In addition, therapy parameters may include anatomical parameters such as the location, shape, thickness, and orientation of adipose tissue 206 and non-adipose tissue. An anatomical parameter may also include a density of adipose tissue 206 and non-adipose tissue. In addition, therapy parameters include the type of probe 126 used during the therapy session. The patient's age, gender, weight, ethnicity, genetics or medical history may also be therapy parameters. After applying therapy to treatment space 212, system 120 or the operator may adjust therapy parameters before applying therapy to treatment space 212 again or another treatment space.

Turning to Fig. 12, in some embodiments, display 138 may overlay another graphic representation, such as a marker 240, over image 204 designating the treatment site or sites 222. The size and shape of marker 240 may correspond to a size and shape. focal region shape of probe 126. As therapy beam 224 moves treatment site 222 into treatment space 212, display 138 can continually update marker 240 to cover new points in treatment space 212 as New points are receiving therapy. In some embodiments, marker 240 may only correspond to the point or points in the treatment space that are currently receiving treatment.

However, in other embodiments, the marker 240 or other graphical representation may also indicate a trajectory in the treatment space 212 that has received therapy. For example, if the treatment site 222 is continuously applied and moved in the treatment space 212, the path may be indicated by a thick line (for example, as an ink stroke) along the path. If therapy is applied at separate and separate points, a graphical representation, such as marker 240, may be left at each point. As such, at one end of the therapy session, image 204 may have multiple markers 240 superimposed on image 204 indicating where therapy was applied. In some embodiments, graphical representations indicating past therapy may remain on image 204 indefinitely (ie, until removed by the user or until completion of the therapy session). In other embodiments, graphical representations indicating past therapy may change as time progresses. Such graphical representations may indicate a time since therapy application, tissue fluidity, temperature, tissue stiffness, or some other tissue characteristic that may change over time. As an example, when therapy is first applied to a point, the graph may be red to indicate that the point has recently received therapy. As time progresses, the graphical representation may fade or change to another color (for example, blue) to indicate that a predetermined period of time has elapsed since therapy application to the point. Figure 13 illustrates an ultrasound system 300 formed according to one embodiment. System 300 may include features and components similar to those described above with respect to figures 1-11. More specifically, system 300 includes a laptop computer 302 having a primary display 304 and which is communicatively coupled with a secondary display 306. Computer 302 may also include software and internal circuitry configured to perform as described above. with respect to system 120 (Figure 2). System 300 includes a probe 326 that is coupled to computer 302 and has a probe position device 370. The system also includes a reference position device 372 that may be located near the patient or may be attached to the patient. Position devices 370 and 372 may have transmitters and / or receivers that communicate with each other and / or with computer 302. For example, position devices 370 and 372 may communicate with a position tracking module (not shown). , like the position tracking module 148 shown in Fig. 2, the position tracking module can receive signals from position devices 370 and / or 372. In a specific embodiment, position device 372 has a pair of coils that creates an electromagnetic field. The position tracking module receives data (e.g., positional information) from position devices 370 and 372 relative to a probe 326 location. As probe 326 delivers therapy to the patient and is moved along the patient, the Display 304 and / or 306 may show probe 326 movement relative to the patient.

Also shown in figure 13, system 300 can be configured to record where therapy will be applied during the therapy session. System 300 may include an electronic pen 374 and fiducial element 376 attached to the patient's body. The fiducial element 376 is fixed near the patient's sternum in Figure 13, but may be fixed in other spaces. A user wishing to sketch or outline where the therapy will be applied may use the 374 electronic pen to trace on the patient's body. First, the electronic pen 374 may register with the fiducial element 376 so that the location of the electronic pen 374 with respect to the patient's body is known. Upon registration, the 374 electronic pen moves along the body surface and communicates with the 302 computer a current position of the 374 electronic pen. In addition, the 374 electronic pen can mark the patient's body (for example, by ink, resin or other substance) where therapy will be applied. The computer 302 uses the data received by the electronic pen 3 74 and the position device 372 to indicate on the display 306 where therapy should be applied. As shown, display 306 may show a graphical representation 382 of a side view of the body and a graphical representation 384 of an anterior view of the body. Computer 302 uses the information from the electronic pen 374 to sketch a region 386 of the body to be treated. Region 386 may be green in color prior to treatment. In an alternative embodiment, a single element or device may perform the functions of fiducial element 376 and reference position device 372.

As an example, graphical representations 382 and 384 may be digital photographs of the patient's body. When therapy is applied to the body, computer 302 tracks the position of probe 326. As therapy is applied, display 306 indicates overall progress of the therapy session. For example, display 306 may show the user the body region currently receiving therapy, the body regions that have already received therapy, and the body regions that have yet to receive therapy. For example, regions receiving therapy may be red and regions not receiving therapy may be green. Also, a graphical representation 380 of probe 326 may be shown on display 306 to indicate a current position of probe 326 with respect to the body.

Figure 14A is a flow chart illustrating a method 900 for delivering therapy to at least one ROI in a patient. Method 900 may be performed by a user or an operator of a therapy and imaging system. For example, the system used may be systems 120, 300 or 450 (discussed above) or other systems described below. The therapy session may start at 902 when the operator positions a probe at a predetermined location on the patient's body to view an ROI. ROI can be one of many that will be displayed during the therapy session. ROI ultrasound imaging signals are obtained at 904. The signals can be processed into data through different ultrasound submodules, such as the 152-166 modules described above with reference to the figure.

2. In one embodiment, signals are processed into data through at least one of elastography and B-mode processing.

An ROI image is generated and displayed to the operator and optionally patient at 906. The image can be, for example, a B-mode image on a gray and / or color scale. The image can also be a combination of images that are overlaid or arranged side by side on a viewfinder. For example, the image may be formed from data obtained through B-mode processing and data obtained through elastography. Optionally, the system can automatically differentiate adipose tissue from other tissues in 908 and indicate to the operator the different layers of tissue in the image. The system can indicate the differentiation of tissues in the image to the user through lines, color, brightness or other visual indications. In addition, the system can automatically designate a treatment space at 910 by overlapping a graphical presentation (e.g., line) that indicates a boundary between the tissue layers.

However, the system may also accept user input at 912 from the operator after a simple image (ie, an image without graphs or other indications) of the ROI is displayed or after an image is displayed that automatically differentiates the tissues and indicates the different fabrics for the operator. User entries can designate a treatment space. The system may display in 914 a graphical representation (for example, a sketch) of the designated treatment space. The system may then automatically set therapy parameters at 916 and / or the system may accept user inputs for therapy parameters at 918. For example, the system may determine mechanical properties of the treatment space using the shear wave methods described above. . Based on the mechanical properties determined, the system can adjust therapy parameters. Optionally, at 920, the operator can assign a therapy path in the treatment space. Therapy is then provided to a treatment site at 922 in the designated treatment space. The system may optionally at 924 display a graphical representation (e.g. a marker) of the image treatment site.

After or while providing treatment to the treatment space, the system may obtain ultrasound signals from the treatment space at 926. At 928, the system determines if treatment is complete. If treatment to the corresponding treatment space is not complete, the system may automatically adjust the therapy parameters at 930 and / or automatically move the treatment site at 932 to another point in the treatment space. The treatment site may move while providing treatment or after treatment has ceased to a specific point. In addition, therapy parameters can be adjusted while the treatment site is moving. Optionally, the system may display a graphical representation indicating the path taken by the treatment site in the treatment space at 934. The system provides therapy for a new point and continues this process until therapy for the corresponding treatment space is complete.

Upon completion of therapy for the treatment space, the system can determine (or ask the operator) at 936 if patient therapy is complete. If therapy for the patient is complete, then the therapy session is over. However, if the therapy session is not complete, then the system or operator may move the probe at 938 to another location on the patient. In some embodiments, the system may also track a probe location 940 as the probe moves to another location. The system can also display to the operator those regions that have already been treated and those regions that have not been treated.

Although the flowchart illustrates sequential steps in method 900, embodiments of the present invention include methods that perform fewer steps and also methods that perform steps in different orders or may perform steps simultaneously. For example, the system may display an ROI image after the system has automatically differentiated adipose tissue from other tissues. The system can also deliver therapy to a ROI treatment site while simultaneously obtaining imaging signals and displaying an ROI image during therapy.

Figure 14B is a flowchart illustrating a sub-method 950 for confirming that an effective amount of therapy has been delivered to a treatment site in a patient's ROI. Before therapy is delivered to a treatment site at 922, the system can automatically or can be user driven to determine a baseline condition and a 952 offset reference condition from a tracking site located near the treatment site. treatment. Baseline condition can be determined by tracking the screening site when the adipose tissue is at rest. A shear wave can then be generated at a generation site that is close to the treatment site where the treatment site is substantially between the generation and tracking sites. The displaced reference condition can be determined by tracking the tracking site when a shear wave propagates through the tracking site before the treatment site receives therapy. In 922, therapy is provided to the treatment site. Method 950 also includes determining in 962 whether the treatment site received an effective amount of therapy by propagating a shear wave from the generation site to the tracking site. The treatment site received an effective amount of therapy if the shear wave is not detected at the screening site. The treatment site did not receive an effective amount of therapy if the shear wave was detected at the tracking site and the shear wave was not substantially affected by propagation through the treatment site. If the treatment site has not received an effective amount of therapy at the treatment site, then the system determines whether the same treatment site should be treated or if a different treatment site located near the original treatment site should be treated. The system then provides therapy at 922 for the chosen treatment site. The therapy may be the same as above or include a different set of therapy parameters that may be more effective in treating. If the original treatment site did not receive an effective amount of therapy, the system moves to step 926.

Figure 15 shows another example of an ultrasound system and, in particular, a hand-held or pocket size ultrasound imaging system 676. In system 676, a 642 display and a user interface 640 form a single unit. As an example, the 676 Pocket Size Ultrasound Imaging System may be a hand size or pocket size ultrasound system approximately 2 inches wide, approximately 4 inches long and approximately 0.5 inches. inch deep and weighs less than 3 ounces. The display 642 may be, for example, a 320 χ 320 pixel color LCD display (on which a medical image 690 may be displayed in combination with a graphic representation (s) as described above). A keyboard similar to the 680 680 button typewriter may optionally be included in the 640 user interface. It should be noted that various embodiments may be implemented with respect to a 676 pocket size ultrasound system having dimensions, weights and different power consumption.

Multi-function Controls 684 can be individually assigned functions according to the system's operating mode. Therefore, each of the multifunction controls 684 can be configured to provide a plurality of different actions. Label display spaces 686 associated with 684 multi-function controls may be included as needed on display 642. The 676 system may also have additional keys and / or 688 controls for special purpose functions, which may include but are not limited to. to "freeze", "depth control", "gain control", "color mode", "print" and "store".

As another example shown in Figure 16, a console-based ultrasound system 745 may be provided on a mobile base 747 that may be configured to display the region of interest during a therapy session. The 745 system may also be referred to as a cart-based system. A 742 display and 740 user interface are provided and it should be understood that the 742 display can be separate or detachable from the 740 user interface. The 740 user interface can be optionally a touch screen, allowing the operator to select options by touching graphics. displayed, icons and the like.

The 740 user interface also includes control knobs 752 which may be used to control the 745 or required portable ultrasound imaging system and / or as typically provided. The 740 user interface provides multiple interface options that the user can physically manipulate to interact with ultrasound data and other displayable data, as well as enter user inputs and set and change therapy or imaging parameters. Interface options can be used for specific inputs, programmable inputs, contextual inputs, and the like. For example, a 754 keyboard and 756 track bali may be provided. System 745 has at least one probe port 760 for accepting probes.

Figure 17 is an exemplary mode block diagram in which various embodiments described herein may be stored, distributed and installed in computer readable medium. In Figure 17, the "application" represents one or more of the process methods and operations discussed above.

As shown in Figure 17, the application is initially generated and stored as source code 1001 in a computer readable medium of source 1002. Source code 1001 is then transferred across trajectory 1004 and processed by a compiler 1006 to produce source code. object 1010. object code 1010 is transferred across path 1008 and saved as one or more application masters on a master computer readable medium 1011. object code 1010 is then copied numerous times as indicated by path 1012 to producing production application copies 1013 which are saved in separate production computer readable medium 1014. the production computer readable medium 1014 is then transferred, as indicated by path 1016, to various systems, devices, terminals and the like. In the example of Figure 17, a user terminal 1020, a device 1021, and a system 1022 are shown as examples of hardware components in which the production computer readable medium 1014 is installed as applications (as indicated by 1030-1032). . Source code can be written as scripts, or in any low level or high level language. Examples of production computer readable source, master, and medium 1002, 1011, and 1014 include, but are not limited to, CDROM, RAM, ROM, flash memory, RAID drives, memory in a computer system, and the like. Examples of paths 1004, 1008, 1012, and 1016 include, but are not limited to, network paths, internet, Bluetooth, GSM, infrared wireless LANS, HIERPLAN, 3G, satellite, and the like. Trajectories 1004, 1008, 1012, and 1016 may also represent private or public carrier services that carry one or more physical copies of the production source, master, or media 1002, 1011, or 1014 between two geographic locations. Trajectories 1004, 1008, 1012, and 1016 may represent execution flows performed by one or more processors in parallel. For example, one computer may retain source code 1001, compiler 1006, and object code 1010. Multiple computers may operate in parallel to produce production application copies 1013. Trajectories 1004, 1008, 1012, and 1016 may be intra-parallel. state, interstate, intra-country, inter-country, intra-continental, intercontinental, and the like.

As used in all descriptive reports and claims, the phrases "computer readable medium" and "instructions set to" will refer to any or all of i) the computer readable medium of source 1002 and source code 1001, ii) the master computer readable medium and object code 1010, iii) production computer readable medium 1014 and production application copies 1013 and / or iv) applications 1030-1032 saved in memory on terminal 1020, device 1021, and system 1022 .

The various embodiments and / or components, for example, the monitor or display, or components and controllers thereon, may also be implemented as part of one or more computers or processors. The computer or processor may include a computing device, an input device, a display unit, and an interface, for example, for accessing the Internet. The computer or processor may include a microprocessor. The microprocessor can be connected to a communication bus. The computer or processor may also include a memory. Memory can include Random Access Memory (RAM) and Read Only Memory (ROM). The computer or processor may further include a storage device, which may be a hard disk drive or a removable storage unit such as a floppy disk drive, optical disk drive and the like. The storage device may also another similar means for loading computer programs or other instructions on the computer or processor.

As used herein, the term "computer" may include any processor based or microprocessor based system including systems using microcontrollers, reduced instruction set computers (RISC), application specific integrated circuits (ASICs), logic circuits, and any other circuit or processor capable of performing the functions described herein. The above examples are exemplary only, and thus are not intended to limit the definition and / or meaning of the term "computer" in any way.

The computer or processor executes a set of instructions that are stored in one or more storage elements to process input data. The storage elements may also store data or other information as desired or required. The storage element may be in the form of an information source or a physical memory element in a processing machine.

The instruction set may include various commands that instruct the computer or processor as a processing machine to perform specific operations such as the methods and processes described herein. The instruction set may be in the form of a software program. The software can be in many forms such as system software or application software. In addition, the software may be in the form of a collection of separate programs, a program module in a larger program, or a portion of a program module. The software may also include modular programming in the form of object oriented programming. Processing of input data by the processing machine may be in response to user commands, or in response to previous processing results, or in response to a request made by another processing machine.

As used herein, the terms "software" and "firmware" are interchangeable, and include any computer program stored in memory for execution by a computer, including RAM, ROM, EPROM, EEPROM, and nonvolatile RAM ( NVRAM). The above memory types are exemplary only, and thus are not limiting with respect to the memory types usable for storing a computer program.

Although the embodiments described herein are illustrated as treating adipose tissue, alternative embodiments may be used to treat other tissues in the body. For example, the embodiments described above may be used to image and treat a tumor in a region of interest. As described above with respect to adipose tissue, modalities may be used to automatically identify the tumor and / or allow user input to identify treatment spaces in a region of interest and set therapy parameters for treatment. In addition, embodiments described herein may be used for palliative cancer treatments, muscle heat treatment, or ultrasonically activating drugs, proteins, stem cells, vaccines, DNA, and gene delivery.

It should be understood that the above description is intended to be illustrative and not restrictive. For example, the embodiments described above (and / or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a specific situation or material to the teachings of the invention without departing from its scope. Dimensions, types of materials, orientations of the various components, and the number and positions of the various components described herein are intended to define parameters of certain embodiments, and are by no means limiting and are merely exemplary embodiments. Many other embodiments and modifications comprised in the spirit and scope of the claims will be apparent to those skilled in the art upon examination of the above description. The scope of the invention should therefore be determined with reference to the appended claims, together with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms "including" and "in which" are used the simple English equivalents of the respective terms "comprising" and "where". Further, in the following claims the terms "first", "second" and "third", etc. they are used merely as labels, and are not intended to impose numerical requirements on their objects. In addition, the limitations of the following claims are not written in a positive-middle function format, and are not intended to be construed on the basis of 35 USC §112, sixth paragraph, unless and until such claim limitations express the use of the phrase "middle to" followed by a function declaration without additional structure.

The written description uses examples to disclose the invention, including the best mode, and also to enable anyone skilled in the art to practice the invention, including making and using any devices or systems and performing any embodied methods. The patentable scope of the invention is defined by the claims and may include other examples which occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with non-substantial differences from the literal languages of the claims.

Claims (10)

1. Ultrasound system, configured to determine if a patient's adipose tissue has received therapy at a treatment site -222, said system comprising: an ultrasound probe 126; a shear wave generation module 123 to control probe 126 to provide a shear wave beam that is configured to generate a shear wave at a first patient site, the shear wave being configured to propagate through the treatment site 222 toward a second site in the patient; and a tracking module 164 for controlling probe 126 for tracking the shear wave at the second site in the patient to determine if treatment site 222 has received therapy. A system according to claim 1 further comprising a therapy module 125 for controlling probe 126 for delivering therapy to treatment site 222 in adipose tissue. A system according to claim 2, wherein the treatment site 222 is a first treatment site 222 located substantially between the first and second sites, probe 126 being controlled to deliver therapy to a second treatment site 222. at the first site, and therapy at the second treatment site 222 generates the shear wave that propagates toward the second site. A system according to claim 1, wherein the first site is located at the treatment site 222. A system according to claim 1, wherein the first site is located such that the treatment site 222 is substantially between the first and second sites. A system according to claim 1, wherein the probe 126 is configured to apply acoustic radiation force to the first site to generate the shear wave. A system according to claim 1 wherein the tracking module 164 is configured to control probe 126 to distribute one or more tracking pulses to the second site. A system according to claim 1, further comprising a display for showing a region of interest including the treatment site 222 for an operator, the display showing a graphical representation of the treatment site 222. 9. METHOD, To determine if a patient's adipose tissue received therapy at a treatment site 222, the method comprising: providing a shear wave beam to generate a shear wave at a first patient site, the shear wave being configured to propagate through treatment site 222 toward a second site in the patient; and tracking the shear wave at the second site in the patient; and determining if treatment site 222 received therapy. The method of claim 9, wherein the determination includes determining that treatment site 222 had received an effective amount of therapy if the shear wave had been substantially affected by propagation through treatment site 222.