The field of the invention relates generally to thermal and mechanical energy treatment systems and, more particularly, to systems and methods for controlling the intensity of acoustic energy transmitted from an array of transducer elements in a manner as to simultaneously produce multiple foci, each directed at a different target site.
High-intensity focused acoustic waves, such as ultrasound or acoustic waves at a frequency greater than about 20 kilohertz, may be used to therapeutically treat tissue regions within a patient. For example, ultrasound waves may be used in applications involving ablation of tumors, thereby eliminating the need for invasive surgery, targeted drug delivery, control of the blood-brain barrier, lysing of clots, and other surgical procedures.
Focused ultrasound systems typically include piezoelectric transducer elements (also referred to herein as “elements”) that are driven by electric signals to produce ultrasound energy. In such systems, a transducer may be geometrically shaped and positioned such that ultrasound energy emitted by an array of transducers collectively forms a focused beam at a “focal zone” corresponding to the target tissue region. As used herein, the terms “beam,” “energy beam,” or “acoustic energy beam” refer generally to the sum of the waves emitted by the various transmitting elements of a focused ultrasound system.
High-intensity focused ultrasound treatments direct the acoustic beam at the target area to achieve intensities or power densities that are high enough to destroy tissue, e.g., via coagulation or non-thermal mechanical effects. However, tissue along the acoustic beam path also absorbs energy (albeit at significantly lower intensities), so that each sonication induces a slow temperature rise in the non-targeted tissue. In conventional methods, the transmission of the acoustic beam is halted periodically to allow the tissue in the path zone to cool down to a baseline temperature. Since the cooling is achieved by perfusion and diffusion, which are slow processes, the need for cooling periods significantly increases the overall treatment time, which in turn limits the adoption of focused ultrasound as a preferred method of treatment. In most instances the heating/treatment rate of targeted tissue is limited by the need to minimize heating of the non-targeted tissue. Therefore, if heating of non-targeted tissue could be significantly reduced or even eliminated, acoustic energy could be delivered more or less continuously, thus decreasing the treatment time.
Tissue heating rates depend on the intensity (energy density) of the acoustic beam applied to the tissue. This implies that reducing the intensity in the beam path zone will reduce treatment times. Further, because the intensity is inversely proportional to the transducer area, using a transducer having a large area could reduce the energy density in the path zone (and, hence, treatment times). But because transducer elements have a finite size and the beams generated by the elements have particular directionalities, the energy contribution of a particular element diminishes as the steering angle relative to the target zone increases; in particular, elements having a high steering angle with respect to the target provide a limited contribution to the intensity at the focus site, thus introducing a significant amount of “ineffective” energy into the volume. In these situations where only part of the transducer area is effectively contributing to energy reaching the focus, the non-contributing elements are typically switched off—i.e., their potential contributions are effectively wasted.
It would be beneficial, therefore, to utilize the transducer elements not being directed at a lesion or target area to simultaneously deliver focused ultrasound to additional target areas.
Embodiments of the invention provide techniques and systems that facilitate the simultaneous application of focused ultrasound to multiple target sites in a manner that reduces overall treatment time while avoiding harm to healthy anatomy outside the target zones. More specifically, a transducer surface is segmented into sub-areas (also referred to as “element groupings”), each of which results in a separate focus directed to a different target area. To maintain independence among the groupings, a maximum allowable (or in some cases no) beam path zone overlap is adhered to. The ability to simultaneously treat multiple foci (e.g., multiple nodules or tumors) greatly accelerates the treatment rate, and therefore overall acceptance of focused ultrasound as a treatment modality.
Thus, in a first aspect of the invention, a system for delivering acoustic energy to multiple target sites within a patient includes a transducer array comprising multiple transducers, each of which transmits acoustic energy to a respective focus. The foci are discontiguous (i.e., spatially distinct) and address a pattern of target sites. The system also includes a processor coupled to the array for establishing targeting criteria corresponding to the pattern and a controller coupled to the processor and the transducer elements for driving (e.g., providing excitation signals to) the transducer elements based on the targeting criteria.
In some embodiments, the transducer array includes a plurality of grouped transducer elements based on the targeting criteria, and each group may produce ultrasound energy at different frequencies and/or have different focal lengths. The groups may be activated (and thus deliver acoustic energy) simultaneously, or, in some cases, quasi-simultaneously in rapid-switching fashion. The transducer groups, in other words, can be selected and grouped ad hoc from a set of available transducer elements based on the desired targeting geometry. That geometry may include steering angles of the transducer elements with respect to each of the target sites, lines of sight from the transducer elements to each of the target sites, anatomical features of the patient, locations of the target sites within the patient, and/or f-numbers (i.e., the focal length divided by an emitting area) of the transducer elements.
Each group of transducer elements may be independently controllable, and may include a single beamformer for driving each of the transducer element groups, or a multiple beamformers, each driving one of the transducer element groups. In some cases, the transducer element groups are mechanically connected and/or flexibly connected to allow for contortion of the array about a patient. In some implementations, the element groupings may be defined such that the lines of sight from each element group to its corresponding target site do not pass through a previously-identified no-pass region and/or such that any overlap of the lines of sight from each element group to its corresponding target site remains below an overlap threshold.
The system may, in some embodiments, also include an imager for capturing a single image that includes all the target sites, a series of images of the multiple target sites, or in some implementations, multiple imagers are used to simultaneously generate multiple images of the target sites.
In another aspect of the invention, a method for simultaneously delivering focused ultrasound to multiple target sites includes the steps of providing an ultrasound transducer array comprising multiple transducer elements and determining targeting criteria for each element with respect to the target sites. The method also includes determining element groupings based on the targeting criteria and driving the transducer elements based upon the element groupings in order to simultaneously focus acoustic energy transmitted by the transducer elements at the different target sites.
In some embodiments, multiple independent transducer arrays may be mechanically connected to form the ultrasound transducer array. The targeting criteria may include, for example, steering angles of the transducer elements with respect to each of the target sites, lines of sight from the transducer elements to each of the target sites, and/or f-numbers of the transducer elements. The groups may be activated (and thus deliver acoustic energy) simultaneously, or, in some cases, quasi-simultaneously in rapid-switching fashion. In some cases, a no-pass region (or regions) may be defined through which no ultrasound energy is permitted to pass and the element groupings are determined such that the lines of sight from each element grouping to its corresponding target site do not pass through the no-pass region(s). In still other cases, the element groupings may be defined such that any overlap of the lines of sight from each element grouping to its corresponding target site remains below an overlap threshold. Images of the various target zones may be taken to confirm the delivery of ultrasound energy to the target zones.
In another aspect, the invention relates to an article of manufacture having computer-readable program portions embodied therein for authentication using biometrics. The article comprises computer-readable program portions for performing the method steps described above.
In the drawings, like reference numbers represent corresponding parts throughout.
High-density ultrasound transducers may utilize a two-dimensional grid of uniformly shaped piezoelectric (PZT) “rods” glued to a conductive matching layer substrate. For both manufacturing and performance reasons, the PZT rods typically have rectangular (or square) profiles, with an aspect ratio (i.e., ratio of height to width) of greater than or equal to one, and are preferably uniform in size to produce the same frequency response. Spacing between the rods also influences the acoustic performance of the transducer and is preferably minimized such that it is smaller than the size of the rods themselves. A high-density phased-array transducer may have hundreds, even thousands of densely packed piezoelectric rods, each having a relatively small (e.g., 1 mm2) energy transmitting surface.
Such transducer arrays have been used to apply acoustic energy to patients for both imaging and therapeutic purposes. Typical therapeutic applications provide a focused beam of acoustic energy to a single focal point (usually within the boundaries of a lesion or tumor) in order to ablate the diseased tissue. The ability to focus the ultrasound at small, well-defined regions by varying the driving signals of the transducer elements permits the targeting of small lesions embedded deep within a patient while avoiding excessive heating of (and consequent damage to) healthy tissue. However, if multiple lesions are to be treated, the transducer is ordinarily applied to the patient separately for each lesion, requiring time-consuming parameter and equipment adjustments.
Referring now to
In some embodiments, each element may be connected to its own electronic drive signal input, such that each element forms a distinct transducer element that can operate independently of the others, and the elements 305 may therefore be grouped arbitrarily. The acoustic attributes (e.g., frequency response, efficiency, etc.) of the array 205 are influenced by the three-dimensional structure of the individual elements 305, and preferably the height of each element is equal or greater than its width. However, the steering/focusing ability of the transducer array 205 is fully defined by the geometric surface (i.e., the overall area of the transducer elements that emit respective acoustic waves with the same phase) of the respective elements 305.
Still referring to
The groupings may be determined by one or more targeting criteria that specify the geometric relationships among the elements 305 and/or between the elements 305 and the target sites (e.g., steering angles and/or lines of sight). The targeting criteria may also consider the physical locations of the target areas, the number of target areas, anatomical features within the target areas (or surrounding areas, such as vital organs) as well as characteristics of the elements themselves.
As an example,
From a physical point of view, a single transducer element emits a wave in the form of a spreading beam. The angular distribution of this spreading beam is called “directivity.” While a single small element of an array (if it is the only element that is activated) may not produce a focused beam, an array of activated elements can produce a focused beam, where the size of the “focus” is smaller when the combined transducer elements form a larger emitting surface. Each transducer element contributes to the focus proportionally based on its directivity at the “focus” and the power it transmits. Thus, the steering region of a phased-array transducer depends on each element's directivity patterns.
The relationship between an element's surface size and its steering ability can be represented in terms of its half-energy angle. For example, a transducer element may have a size-to wavelength value of /d/λ, where d is the size of the element in one dimension (e.g., width) and λ is the wavelength of the wave emitted by the element. In such a case, the half energy steering angle, or “steering ability,” of the transducer array with dλ=1 is 30°. This represents the angle at which a steered-to focal zone has an energy level equal to half the maximum energy that the transducer would contribute to a unsteered focal zone.
Referring to
By “discontiguous” is meant that the focal points are spatially distinct. In some instances the foci are sufficiently separated in space that the beam paths and the affected tissue regions around the foci are also spatially distinct, i.e., do not overlap. In other instances, however, the locations of the lesions L may be such that the beams from two or more element groupings overlap (i.e., more than one beam passes through certain tissue). A small amount of beam overlap may be acceptable, but larger amounts may cause unwanted accumulated heating of non-target tissue or interference. Therefore, in some embodiments, overlap thresholds are established and used to limit the amount (in terms of energy density, time or both) that two or more beams may pass through the same tissue. One example of an energy density threshold for a particular organ or anatomical region is 500 joule/cm2.
In some embodiments, the multi-foci targeting may be implemented in quasi-simultaneous fashion using, for example, rapid switching. In such cases, the element groupings may be activated and deactivated according to a timed sequence so that the acoustic energy is delivered to each of the multiple foci in turn, albeit during a single application. The grouping of transducer elements into different sectors of the entire array may be exclusive, or, in some cases overlap such that some transducer elements are assigned to more than one group. In certain cases, some transducer elements may be ignored completely, if, for example, the trajectory of the acoustic energy is beyond the critical angle at which the contribution of the element is negligible. The selection and execution of a timing pattern may be based, for example, on an analysis of the acoustic path leading from the transducer array to the focal points, the size and/or shape of the desired foci, the depth of the desired foci, as well as other treatment parameters.
Referring to
The array 205 may be constructed, by way of example and not limitation, using a conventional dicing machine, but making much smaller cuts to create a uniform array of piezoelectric elements in the same formation as shown in
The electronic controller 610 is coupled to the drive circuitry and controls phase-shift values and amplitudes of the respective drive signals to further focus the acoustic energy emitted by the grouped transducer elements toward the different target regions. For example, the electronic controller may be configured to control phase-shift values of the drive signals to the transducer elements of the different groupings to simultaneously control the focal distances of the different acoustic energy beams emitted by the transducer element groupings. These parameters are determined and optimized to fullfil a particular set of targeting criteria.
The element groupings and the phase-shift values are determined based on one or more targeting criteria by the processor 605. In particular, the processor may receive information related to the arrangement of the transducer elements within the array, the elements' geometry, elements frequency response, the number and locations of the target areas (with respect to the array, each other, other anatomical structures, or some combination thereof), and in some cases locations of “no-pass-zones” through which no acoustic energy is to be transmitted.
The processor 605 may be implemented in hardware, software or a combination of the two. For embodiments in which the functions are provided as one or more software programs, the program may be written in any one of a number of high level languages such as FORTRAN, PASCAL, JAVA, C, C++, C#, BASIC, various scripting languages, and/or HTML. Additionally, the software can be implemented in an assembly language directed to the microprocessor resident on a target computer; for example, the software may be implemented in Intel 80×86 assembly language if it is configured to run on an IBM PC or PC clone. The software may be embodied on an article of manufacture including, but not limited to, a floppy disk, a hard disk, an optical disk, a magnetic tape, a PROM, an EPROM, EEPROM, field-programmable gate array, or CD-ROM. Embodiments using hardware circuitry may be implemented on, for example, one or more FPGA, CPLD or ASIC processors for controlling the phase, frequency and amplitude of the respective elements.
In some embodiments, the system also includes an imager 615 for capturing and providing images of the lesions (and in some cases general anatomical information) to the processor. The images may be generated by multiple imagers in order to capture different lesions or target areas at the same time, or use a single imager to generate a series of images as the imager is scanning each target area or the whole anatomy. The imager may be, for example, a computed tomography (CT) image, a magnetic-resonance imager (MRI), an X-ray device or an ultrasound imager, or any other suitable medical imaging modality.
Referring to
In some embodiments, before the transducer array is activated to deliver treatment-level ultrasound energy, an acoustic wave simulation is performed to determine if any hot spots will be generated. For example, a computer model of the transducer may be created to model the configuration (e.g., shape, size, and relative position) of the transducer elements. Various operational parameters (such as operation frequencies, amplitudes, and phases for the various transducer elements) can then be applied to the computer model to determine if a hot spot will result from a certain operational condition. As will be appreciated by those skilled in the art, while all transducer elements of an array may be activated in some instances, e.g., in order to maximize an amount of energy delivered to a steered-to target area, in other instances, sufficient therapeutic energy may be delivered without activating all elements of a group.
As used herein, the term “hot spot” refers to a tissue region that is not part of the target having an energy level (which may be measured, for example, in terms of temperature or acoustic pressure) that is above a prescribed (safe) level at which the tissue in the hot spot will be temporarily or permanently injured. Because such hot spot(s) start to appear as the electronic steering angle increases, electronic steering to each possible “steered-to” focal zone must be carefully analyzed for safety purposes before undertaken. Further, the energy absorbed at the hot spot(s) decreases the remaining energy available for contributing to the intended “steered-to” focal zone.
In order to better illustrate the relationship between the electronic steering angle and formation of hot spot(s), consider a one-dimensional array (i.e., row) of transducer elements having a cross sectional dimension scaled to wavelength (i.e., element surface size) of /d/λ=1. If Δφ is a phase difference between neighboring elements of the array, Δφ=d sin(α), maximum energy emission occurs at angles satisfying the relationship:
where λ is an ultrasound wavelength, integer n=0 for the main focus and n≈0 for hot spots. Thus, where d≦λ/2, no hot spots will be formed. As such, the advantages of the embodiments described below particularly apply where the element size is equal to or greater than one-half of the drive signal wavelength.
The electronic steering ability of a transducer device can be defined as
being above a preset threshold. For d>>λ, the steering ability approaches single-element directivity,
As a result of hot-spot generation, large steering angles cannot be practically used where elements sizes are above 0.5λ, since nearly all of the energy that does not go to the steered-to focal zone is concentrated at hot spots. For d=λ, while attempting to steer to 30°, hot spots are produced at −30° of equal intensity as the main focus, reducing the steering ability that can be safely used to about half of the main focus steering ability. It will be appreciated by those skilled in the art that as the steering angle amplitude (absolute value) increases, hot spots begin to appear at numerous different points, and are both uncontrollable and undesirable.
Thus, although particular embodiments of the invention have been shown and described, it should be understood that the above discussion is not intended to limit the invention to these illustrated and described embodiments, which are provided for purposes of example only. Instead, the invention is defined and limited only in accordance with the following claims.
This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 11/461,763, entitled “Ultrasound Transducer with Non-Uniform Elements” filed on Aug. 1, 2006, the entire disclosure of which is hereby incorporated by reference herein.
Number | Date | Country | |
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Parent | 11461763 | Aug 2006 | US |
Child | 12509907 | US |