Ultrasound has been employed to diagnose and facilitate a non-invasive removal of soft tissues such as tumors or calcifications such as kidney stones from the body.
Ultrasound can also be used to noninvasively image stones or other objects in the body, manipulate and move these objects, or fragment them into small pieces so that they can be removed more easily.
The illustrated ultrasound system 100 includes an imaging probe 22 incorporating one or more piezoelectric transducer elements 22i. The operation of the imaging probe 22 is analogous to that of the therapy probe 14. Namely, the imaging transducer elements 22i also transmit ultrasound waves toward the object of interest, but typically at a frequency that is different from that of the therapy transducer. When the imaging ultrasound waves impinge on the object of interest (e.g., a kidney stone) and reflect back toward the piezoelectric elements 22i of the imaging probe 22, the reflected ultrasound waves generate AC signals in the imaging transducer elements 22i. These AC signals are processed by an imaging system 20, and displayed on a display 30 of the system to provide an indication of, for example, shape, location, or motion of the object of interest or the surrounding tissue.
In some systems, the therapy probe and imaging probe are coupled to form a combined probe. An example of such combined probe is illustrated in
However, due to limitations of ultrasound imaging, patient motion, and other system limitations, there may be a loss of targeting accuracy, wherein the therapy probe 14 is not optimally aimed towards the therapy target (e.g., kidney stone). Furthermore, the images obtained by the imaging transducer 22 typically correspond to a single focal plane in a 3D space, therefore providing limited feedback regarding the displacement of the target object out of the plane of the image. For more comprehensive imaging of the target object, multiple focal planes may be helpful. However this added feature may reduce the imaging frame rate or otherwise compromise the image quality, while greatly increasing the complexity of the imaging probe and imaging system. Accordingly, there remains a need for improved targeting systems and methods for the therapy ultrasound.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features of the claimed subject matter.
Briefly, the inventive technology is directed to systems and methods for locating and targeting objects in a body. With conventional technologies, an operator often does not have good visualization of the desired target. While diagnostic ultrasound imaging of the conventional technology can provide image guidance and visualization of an in-vivo target, it cannot always indicate whether the therapy pulse is targeting the target object correctly or whether the therapy ultrasound is having the desired therapeutic effect.
The inventive technology improves targeting of the objects by therapeutic ultrasound. In some embodiments, targeting is based on the therapy ultrasound that is reflected toward ultrasound receivers. Linking the emitted therapy ultrasound to the received reflected therapy ultrasound may provide an indication of the accuracy of the targeting (also referred to as the “accuracy of locating” or “accuracy of aiming”). Different embodiments of the inventive technology may be used to treat kidney stones, gallbladder stones, arterial calcification, cardiac valve calcification, and/or other target objects. When the emitted therapeutic ultrasound impinges upon a hard object (e.g., a stone or a calcification) in the body, the reflected therapy ultrasound may have higher amplitudes or specific frequencies which are not present in the therapy ultrasound that reflected from a soft tissue, which is then used to confirm the accuracy of the targeting.
In some embodiments, targeting is based on the sound emissions associated with the therapeutic activity arising from the interaction of the therapeutic ultrasound waves impinging on the therapy target (e.g., kidney stone). In particular, the nature of the sound waveform is indicative of the effectiveness of the therapy, and by inference, how well the therapy ultrasound is targeted on the object. In such embodiments, the sound emissions may be acquired by audio microphones, since the therapy ultrasound, which was outside of the audible range, creates audible sounds through the therapeutic interaction with the target object. Such therapeutic interactions may arise from cavitation bubble collapse, stone fragmentation, stone vibration, stone movement, or other nonlinear interactions between the therapeutic ultrasound and the target object. These nonlinear therapeutic interactions ultimately cause an audible component in the sound, where this audible component, when properly captured and interpreted, provides an insight into location, shape, size, movement, and/or other properties of the target.
In some embodiments, the audible sound may be acquired by the elements of the therapy probe itself (e.g., by the piezo elements of the phased array therapy transducer acting as sound receivers). In different embodiments, the inventive technology may be practiced in conjunction or in absence of the conventional imaging transducers. The technology disclosed herein can be based on different types of therapy ultrasound, including Burst Wave Lithotripsy (BWL), Shockwave Lithotripsy (SWL), or histotripsy. When the therapy ultrasound is emitted in bursts of ultrasound waves (BWL), the bursts are separated by the rest periods when the ultrasound is not emitted. Therefore, the reflected signal may also encode frequency components related to the repetition frequency of the bursts, that frequency being generally lower and, therefore, closer to or within the audible frequency range than the frequency of the ultrasound waves within individual bursts.
In some embodiments, the sound emissions associated-with and caused-by the therapeutic ultrasound impinging on the therapy target (e.g., kidney stone) are processed to provide indicators of the target accuracy that guides the operator during the therapy. Some examples of such indicators of the target accuracy are arrows, target icons, sound indicators emitted by speakers, and haptic indicators. In some embodiments, a robotic manipulator can change the orientation and/or focal plane of the therapy ultrasound transducer based on the accuracy indicators.
In one embodiment, a method for targeting an object in a body using ultrasound includes: producing a therapy ultrasound waveform configured to fragment or comminute the object in the body using a therapy transducer of an ultrasound probe; acquiring a sound waveform by a receiver, where the sound waveform is at least in part caused by interactions of the therapy ultrasound with the object; and generating an indication of a targeting accuracy based on the acquired sound waveform.
In one embodiment, the object is a stone or a calcification.
In one embodiment, the receiver comprises a microphone.
In another embodiment, the microphone and the therapy transducer are carried by a common housing of the ultrasound probe.
In one embodiment, the microphone and the therapy transducer are separate.
In one embodiment, the method also includes: converting a microphone signal into a digitized signal in a time domain; processing the digitized signal into a frequency spectrum; detecting at least one extremum in the frequency spectrum; and determining the targeting accuracy based on the at least one extremum of the frequency spectrum. In one embodiment, generating the indication of the targeting accuracy includes generating an audible feedback or a light feedback.
In another embodiment, generating the indication of the targeting accuracy includes generating a haptic feedback.
In one embodiment, generating the indication of the targeting accuracy includes generating an image on a display unit, where a shape, a size or a color of the image indicates the targeting accuracy.
In one embodiment, the method also includes: retargeting the therapy ultrasound waveform based on the indication of the targeting accuracy.
In one embodiment, retargeting the therapy ultrasound waveform includes robotically retargeting the therapy ultrasound waveform.
In one embodiment, the therapy probe incorporates a phased array therapy transducer having a plurality of individually operable transducer elements. The method further includes retargeting the therapy ultrasound waveform by controlling the electrical excitations of the individual elements of the phased array.
In one embodiment, the sound waveform includes sound emissions from cavitation bubbles generated by the therapy ultrasound waveform.
In one embodiment, the therapy ultrasound waveform is transmitted in bursts, where a frequency of the bursts is within an audible range of frequencies, and the sound waveform includes the frequency of the bursts.
In one embodiment, the method includes: generating a Doppler ultrasound audio waveform using an imaging transducer of the ultrasound probe; and generating a display representative of the object motion based on the imaging ultrasound waveform.
In one embodiment, the imaging ultrasound waveform includes a pulse wave Doppler (PWD) ultrasound.
In one embodiment, an apparatus for treating an object in a body using ultrasound includes: an ultrasound probe having a therapy transducer configured to fragment or comminute the object in the body by a therapy ultrasound, and an imaging probe configured to image the object by an imaging ultrasound. The receiver is configured to detect a sound waveform, where the sound waveform is at least in part caused by interactions of the therapy ultrasound with the object. The apparatus also includes an indicator configured to indicate a targeting accuracy based on the sound waveform detected by the receiver.
In one embodiment, an apparatus for treating an object in a body using ultrasound includes an ultrasound probe having a therapy transducer configured to fragment or comminute the object in the body by a therapy ultrasound, and an imaging probe configured to image the object by an imaging ultrasound. The apparatus also includes a receiver configured to detect a sound waveform; and an indicator configured to indicate a targeting accuracy based on the reflected ultrasound waveform detected by the receiver.
In one embodiment, the receiver is a microphone.
In one embodiment, the apparatus further includes a controller configured to adjust a target therapy zone based on the targeting accuracy.
In another embodiment, the apparatus further includes a robotic arm configured to adjust a position of the ultrasound probe.
In one embodiment, the therapy transducer is a phased array therapy transducer comprising a plurality of individually operable transducer elements that are configured to generate the therapy ultrasound and to detect the sound waveform.
In one embodiment, the receiver is a bed-side microphone.
In one embodiment, the receiver is a microphone, and the microphone and the therapy transducer are carried by a common housing of the ultrasound probe.
In one embodiment, the apparatus also includes at least one of a speaker or a source of light operationally coupled with the indicator configured to indicate the targeting accuracy.
In one embodiment, the apparatus also includes a haptic element operationally coupled with the indicator configured to indicate the targeting accuracy.
In one embodiment, the apparatus also includes a display unit operationally coupled with the indicator configured to indicate the targeting accuracy, where a shape, a size or a color of the image indicates the targeting accuracy.
The foregoing aspects and many of the attendant advantages of the inventive technology will become more readily appreciated as the same are understood with reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
While several embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the inventive technology.
The illustrated ultrasound probes 210 in
In different embodiments, different mechanisms may cause generation of sound arising from the interaction of the therapy ultrasound with the object (e.g., a bodily stone). In general, these mechanisms are nonlinear, and a consequence of nonlinearity is that the emitted sound frequency may be dramatically different from the frequency of the incident therapy ultrasound. For example, therapy ultrasound at a frequency of hundreds of kHz can give rise to audio and sub-audio frequencies in the range from 10 Hz (or lower) to tens of kHz (and much higher, as well). In contrast, a linear effect such as reflection of the therapy ultrasound from the stone preserves the frequency of the incident therapy ultrasound, such that a therapy ultrasound wave at hundreds of kHz gives rise to a reflected ultrasound wave at the same frequency. Some examples of the mechanisms that generate sound based on interactions between the therapy ultrasound (or diagnostic ultrasound) and the targeted object are discussed below.
1. Cavitation Bubble Collapse
Cavitation bubbles form in the presence of large negative pressure during the negative half-cycle of a therapy ultrasound waveform. Cavitation bubbles form more easily when there are cavitation nuclei present. Cavitation nuclei can consist of tiny dust particles (e.g., stone fragments), small features on the surface of a large stone (e.g., a micro-crack), small bubbles attached to the stone or hiding in a micro-crack, or free-floating micro-bubbles. Once the high pressure sound waves initiate cavitation (forming a small bubble), the bubble begins to oscillate in size from larger during the negative pressure half-cycle (rarefaction) to smaller during the positive half-cycle (compression). During this oscillation process, the bubble may grow in size from cycle to cycle through the process of rectified diffusion, and under certain circumstances, a cavitation bubbles may collapse violently, emitting a loud impulse of sound that can be captured by, for example, microphones 60.
The intensity of the sound is dependent on the number of cavitation events, which is affected by the concentration of cavitation nuclei, which is typically much greater at the stone surface or in the immediate vicinity of the stone compared to regions of soft tissue or fluid. In addition, when a stone fractures, it often releases a cloud of microscopic debris and/or micro-bubbles that briefly increases the concentration of cavitation nuclei in the vicinity of the stone, temporarily increasing the intensity of the sound. Through this mechanism, the location of a stone and the rate/effectiveness of the stone breaking may be identified by the intensity of these sounds.
2. Stone Fracture
The therapy ultrasound can promote stone fracture through several mechanisms. For example, localized stress concentrations arising from sound waves propagating through the bulk or over the surface of the stone can exceed the fracture strength of the stone material, causing a localized fracture. In addition, these stress concentrations can cause the growth of existing micro-cracks in the stone that were present from the outset or that arise from other mechanism. One potential source for initiating micro-cracks in the stone surface is the damage caused by cavitation bubble collapse. Thus, a cavitation nucleus present on the stone surface may give rise to a cavitation bubble which may then collapse violently, inducing damage (e.g., a micro-crack) on the stone surface. Through the process of crack formation and growth, there may be instances where a crack rapidly propagates, releasing broad band sound (e.g., a crack or pop sound). This broad band sound may be captured by, for example, microphones 60 or by the transducers 14-i of the therapy probe 140.
3. Radiation Pressure
When sound waves are absorbed or reflected from an object, they impart momentum to the object, which can be interpreted as a pushing force or pressure on the object, trying to push the object in the direction of sound propagation. In the typical application of burst-wave lithotripsy, the therapy ultrasound is characterized by brief (e.g., 100 microsecond) bursts of high intensity ultrasound repeated at a relatively low burst repetition frequency (e.g., 10 to 100 Hz). Inside the body, the stone may be constrained by the surrounding tissue from gross movement, but the intermittent pushes induced by radiation pressure may cause the stone to move back and forth at the burst repetition frequency (or a harmonic frequency thereof). In some embodiments, the sound associated with this vibration may not be strong enough to be easily detected by a microphone, but the vibratory motion may be detected and translated into an audio signal using, for example, the pulsed-wave Doppler ultrasound of the ultrasound imaging probe 22.
4. Nonlinear Propagation
Nonlinear propagation of high-pressure therapy ultrasound through fluid or body tissue may affect the frequency content of the waves, but the nonlinear propagation may also add second harmonic content (and higher harmonics). Furthermore, the waveform distortion caused by nonlinear propagation may affect the cavitation process itself
5. Frequency Content of the Transmitted Ultrasound Pulse
The sound may arise based on using a pulse instead of a continuous-wave exposure. A pulse contains not just a single frequency component, but a spectrum of frequencies, including those in the audible range. The strength of the sound components depends on the envelope of the waveform. Stated differently, the linear ultrasound pulse may already contain the audible noise. Furthermore, the sound acquired by, for example, microphones 60, may have different amplitudes due to a difference in scattering (e.g., caused by change in cavitation or by stone fragmentation).
Continuing with the discussion of
In some laboratory experiments and in in-vivo pre-clinical porcine trials, the illustrated methods produced distinct audible or haptic feedback signals used for improved targeting of the target object (e.g., a kidney stone). In particular, the amplitude of the feedback signal (e.g., the amplitude of the sound emission associated with the target object) is significantly higher when the target object is within the focal zone of the ultrasound therapy probe 140. In some embodiments, a strong feedback signal was produced at the 10 Hz pulse repetition rate (burst repetition rate) of the ultrasound therapy probe 140.
In other laboratory experiments, it was observed that strong cavitation at the target object may increase the amplitude of the reflected therapy ultrasound, reflected imaging ultrasound, or the sound emission associated with the target object (e.g., caused by the therapy ultrasound interacting with the target object). Since, in some embodiments, strong cavitation is, in fact, undesirable, the method 1100 may guide the operator to target the ultrasound therapy probe 140 away from the zone of cavitation if the reflected therapy ultrasound exceeds a predetermined threshold.
A generator 64 (e.g., a function generator or a source of electrical signals) may generate targeting signals related to the location of the object of interest and/or accuracy of the targeting of the object of interest. In some embodiments, targeting signals include location and/or shape of the target object shown on the display 30. The determination of the location/size/shape of the target object may also rely, at least partially, on the images obtained by the imaging transducer 22. In some embodiments, targeting signals may be displayed or exhibited on the therapy transducer 140 itself, or otherwise proximately to the operator. In different embodiments, targeting signals may be visual, haptic, audible, etc., as explained in more detail with
Many embodiments of the technology described above may take the form of computer- or controller-executable instructions, including routines executed by a programmable computer or controller. Those skilled in the art will appreciate that the technology can be practiced on computer/controller systems other than those shown and described above. The technology can be embodied in a special-purpose computer, controller or data processor that is specifically programmed, configured or constructed to perform one or more of the computer-executable instructions described above. Accordingly, the terms “computer” and “controller” as generally used herein refer to any data processor and can include Internet appliances and hand-held devices (including palm-top computers, wearable computers, cellular or mobile phones, multi-processor systems, processor-based or programmable consumer electronics, network computers, mini computers and the like).
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the disclosure. Moreover, while various advantages and features associated with certain embodiments have been described above in the context of those embodiments, other embodiments may also exhibit such advantages and/or features, and not all embodiments need necessarily exhibit such advantages and/or features to fall within the scope of the technology. Accordingly, the disclosure can encompass other embodiments not expressly shown or described herein.
This application claims the benefit of Provisional Application No. 62/656,869, filed Apr. 12, 2018, which is incorporated herein by reference.
Number | Date | Country | |
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62656869 | Apr 2018 | US |