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Boiling histotripsy (BH) is a mechanical tissue liquefaction method that uses sequences of millisecond-long high intensity focused ultrasound (HIFU) pulses with shock fronts. The BH treatment generates bubbles that move within the sonicated volume due to acoustic radiation force. Since the velocity of the bubbles and tissue debris is expected to depend on the lesion size and liquefaction completeness, it could provide a quantitative metric of the treatment progression. In this study, the motion of bubble remnants and tissue debris immediately following BH pulses was investigated using high-pulse repetition frequency (PRF) plane-wave color Doppler ultrasound in ex vivo myocardium tissue. A 256-element 1.5 MHz spiral HIFU array with a coaxially integrated ultrasound imaging probe (ATL P4-2) produced 10 ms BH pulses to form volumetric lesions with electronic beam steering. Prior to performing volumetric BH treatments, the motion of intact myocardium tissue and anticoagulated bovine blood following isolated BH pulses was assessed as two limiting cases. In the liquid blood the velocity of BH-induced streaming at the focus reached over 200 cm/s, whereas the intact tissue was observed to move toward the HIFU array consistent with elastic rebound of tissue. Over the course of volumetric BH treatments tissue motion at the focus locations was dependent on the axial size of the forming lesion relative to the corresponding size of the HIFU focal area. For axially small lesions, the maximum velocity after the BH pulse was directed toward the HIFU transducer and monotonically increased over time from about 20-100 cm/s as liquefaction progressed, then saturated when tissue was fully liquefied. For larger lesions obtained by merging multiple smaller lesions in the axial direction, the high-speed streaming away from the HIFU transducer was observed at the point of full liquefaction. Based on these observations, the maximum directional velocity and its location along the HIFU propagation axis were proposed and evaluated as candidate metrics of BH treatment completeness.

PURPOSE: Our goal was to test transcutaneous focused ultrasound in the form of ultrasonic propulsion and burst wave lithotripsy to reposition ureteral stones and facilitate passage in awake subjects. MATERIALS AND METHODS: Adult subjects with a diagnosed proximal or distal ureteral stone were prospectively recruited. Ultrasonic propulsion alone or with burst wave lithotripsy was administered by a handheld transducer to awake, unanesthetized subjects. Efficacy outcomes included stone motion, stone passage, and pain relief. Safety outcome was the reporting of associated anticipated or adverse events. RESULTS: Twenty-nine subjects received either ultrasonic propulsion alone (n = 16) or with burst wave lithotripsy bursts (n = 13), and stone motion was observed in 19 (66%). The stone passed in 18 (86%) of the 21 distal ureteral stone cases with at least 2 weeks follow-up in an average of 3.9±4.9 days post-procedure. Fragmentation was observed in 7 of the burst wave lithotripsy cases. All subjects tolerated the procedure with average pain scores (0–10) dropping from 2.1±2.3 to 1.6±2.0 (P = .03). Anticipated events were limited to hematuria on initial urination post-procedure and mild pain. In total, 7 subjects had associated discomfort with only 2.2% (18 of 820) propulsion bursts. CONCLUSIONS: This study supports the efficacy and safety of using ultrasonic propulsion and burst wave lithotripsy in awake subjects to reposition and break ureteral stones to relieve pain and facilitate passage.

Background: Upper urinary tract stones are increasingly prevalent in pet cats and are difficult to manage. Surgical procedures to address obstructing ureteroliths have short- and long-term complications, and medical therapies (e.g. fluid diuresis and smooth muscle relaxants) are infrequently effective. Burst wave lithotripsy is a non-invasive, ultrasound-guided, handheld focused ultrasound technology to disintegrate urinary stones, which is now undergoing human clinical trials in awake unanesthetized subjects. Results: In this study, we designed and performed in vitro testing of a modified burst wave lithotripsy system to noninvasively fragment stones in cats. The design accounted for differences in anatomic scale, acoustic window, skin-to-stone depth, and stone size. Prototypes were fabricated and tested in a benchtop model using 35 natural calcium oxalate monohydrate stones from cats. In an initial experiment, burst wave lithotripsy was performed using peak ultrasound pressures of 7.3 (n = 10), 8.0 (n = 5), or 8.9 MPa (n =10) for up to 30 minutes. Fourteen of 25 stones fragmented to in vivo exposure of kidneys and ureters in a porcine animal model. Conclusions: These data support further evaluation of burst wave lithotripsy as a noninvasive intervention for obstructing ureteroliths in cats.

BACKGROUND: The benefits of removing small (≤6 mm), asymptomatic kidney stones endoscopically is unknown. Current guidelines leave such decisions to the urologist and the patient. A prospective study involving older, nonendoscopic technology and some retrospective studies favor observation. However, published data indicate that about half of small renal stones left in place at the time that larger stones were removed caused other symptomatic events within 5 years after surgery. METHODS: We conducted a multicenter, randomized, controlled trial in which, during the endoscopic removal of ureteral or contralateral kidney stones, remaining small, asymptomatic stones were removed in 38 patients (treatment group) and were not removed in 35 patients (control group). The primary outcome was relapse as measured by future emergency department visits, surgeries, or growth of secondary stones. RESULTS: After a mean follow-up of 4.2 years, the treatment group had a longer time to relapse than the control group (P

INTRODUCTION AND OBJECTIVE: In clinical trial NCT03873259, a 2.6-mm lower pole stone was treated transcutaneously and ex vivo with 390-kHz burst wave lithotripsy (BWL) for 40 minutes and failed to break. The stone was subsequently fragmented with 650-kHz BWL after a 4-minute exposure. This study investigated how to fragment small stones and why varying the BWL frequency may more effectively fragment stones to dust. METHODS: A linear elastic theoretical model was used to calculate the stress created inside stones from shock wave lithotripsy (SWL) and different BWL frequencies mimicking the stone's size, shape, lamellar structure, and composition. To test model predictions about the impact of BWL frequency, matched pairs of stones (1–5 mm) were treated at (1) 390 kHz, (2) 830 kHz, and (3) 390 kHz followed by 830 kHz. The mass of fragments >1 and 2 mm was measured over 10 minutes of exposure. RESULTS: The linear elastic model predicts that the maximum principal stress inside a stone increases to more than 5.5 times the pressure applied by the ultrasound wave as frequency is increased, regardless of the composition tested. The threshold frequency for stress amplification is proportionate to the wave speed divided by the stone diameter. Thus, smaller stones may be likely to fragment at a higher frequency, but not at a lower frequency below a limit. Unlike with SWL, this amplification in BWL occurs consistently with spherical and irregularly shaped stones. In water tank experiments, stones smaller than the threshold size broke fastest at high frequency (p = 0.0003), whereas larger stones broke equally well to submillimeter dust at high, low, or mixed frequencies. CONCLUSIONS: For small stones and fragments, increasing frequency of BWL may produce amplified stress in the stone causing the stone to break. Using the strategies outlined here, stones of all sizes may be turned to dust efficiently with BWL.

Purpose: To test the effectiveness (Participant A) and tolerability (Participant B) of urinary stone comminution in the first-in-human trial of a new technology, burst-wave lithotripsy (BWL). Materials and Methods: An investigational BWL and ultrasonic propulsion system was used to target a 7-mm kidney stone in the operating room before ureteroscopy (Participant A). The same system was used to target a 7.5 mm ureterovesical junction stone in clinic without anesthesia (Participant B). Results: For Participant A, a ureteroscope inserted after 9 minutes of BWL observed fragmentation of the stone to

Objective: Our goals were to validate stone comminution with an investigational burst wave lithotripsy (BWL) system in patient-relevant conditions and to evaluate the use of ultrasonic propulsion to move a stone or fragments to aid in observing the treatment endpoint. Materials and Methods: The Propulse-1 system, used in clinical trials of ultrasonic propulsion and upgraded for BWL trials, was used to fragment 46 human stones (5–7 mm) in either a 15-mm or 4-mm diameter calix phantom in water at either 50% or 75% dissolved oxygen level. Stones were paired by size and composition, and exposed to 20-cycle, 390-kHz bursts at 6-MPa peak negative pressure (PNP) and 13-Hz pulse repetition frequency (PRF) or 7-MPa PNP and 6.5-Hz PRF. Stones were exposed in 5-minute increments and sieved, with fragments >2 mm weighed and returned for additional treatment. Effectiveness for pairs of conditions was compared statistically within a framework of survival data analysis for interval censored data. Three reviewers blinded to the experimental conditions scored ultrasound imaging videos for degree of fragmentation based on stone response to ultrasonic propulsion. Results: Overall, 89% (41/46) and 70% (32/46) of human stones were fully comminuted within 30 and 10 minutes, respectively. Fragments remained after 30 minutes in 4% (1/28) of calcium oxalate monohydrate stones and 40% (4/10) of brushite stones. There were no statistically significant differences in comminution time between the two output settings (p = 0.44), the two dissolved oxygen levels (p = 0.65), or the two calyx diameters (p = 0.58). Inter-rater correlation on endpoint detection was substantial (Fleiss' kappa = 0.638, p

In 1853, Robert Stephenson (1803–1859) travelled to North America, principally in connection with the design and construction planning of the Victoria Bridge across the River St. Lawrence at Montre...

We thank Jack Suess and Damian Doyle (UMBC Division of Information Technology)for their enthusiastic cooperation. Thanks to Richard Baldwin and Travis Scheponik for helpful comments. This project was supported in part by the National Science Foundation under SFS grants 1241576 and 1753681. Sherman was also supported by the National Science Foundation under SFS capacity grant 1819521 and by the U.S. Department of Defense under CAE-R grant H98230-17-1-0349 and CySP grants H98230-17-1-0387 and H98230-18-0321.

Renal colic encounters are common; in the United States alone, they represent greater than one million annual emergency department (ED) visits. Most of these stones are managed conservatively with a trial of passage. However, some lead to repeat colic episodes, secondary ED visits, increased anxiety, and increased cost. Of the 5%–10% of symptomatic stones that become lodged at the ureteropelvic junction and are larger than 5 mm, most require operative intervention. In the process of executing a NASA‐funded study of ultrasonic repositioning of kidney stones, the subject was administered fluid to dilate the collecting system, placed in Trendelenburg bed positioning, and rolled to both sides. During this process a symptomatic, obstructing 9‐mm ureteropelvic junction stone moved back into the kidney's lower pole/infundibulum and symptoms were immediately resolved. The patient remained asymptomatic for a period of 5 weeks at which point elective intervention was scheduled. This case demonstrates that ureteropelvic junction stones may be repositioned in a non‐invasive manner, turning a stone that requires urgent intervention into one that can be managed electively.

Burst wave lithotripsy is a method to noninvasively fragment urinary stones by short pulses of focused ultrasound. In this study, physical mechanisms of stone fracture during burst wave lithotripsy were investigated. Photoelasticity imaging was used to visualize elastic wave propagation in model stones and compare results to numerical calculations. Epoxy and glass stone models were made into rectangular, cylindrical, or irregular geometries and exposed in a degassed water bath to focused ultrasound bursts at different frequencies. A high-speed camera was used to record images of the stone during exposure through a circular polariscope backlit by a monochromatic flash source. Imaging showed the development of periodic stresses in the stone body with a pattern dependent on frequency. These patterns were identified as guided wave modes in cylinders and plates, which formed standing waves upon reflection from the distal surfaces of the stone model, producing specific locations of stress concentration in the models. Measured phase velocities compared favorably to numerically calculated modes dependent on frequency and material. Artificial stones exposed to bursts produced cracks at positions anticipated by this mechanism. These results support guided wave generation and reflection as a mechanism of stone fracture in burst wave lithotripsy.

Unlike shock wave lithotripsy, burst wave lithotripsy (BWL) uses tone bursts, consisting of many periods of a sinusoidal wave. In this work, an analytical theoretical approach to modeling mechanical stresses in a spherical stone was developed to assess the dependence of frequency and stone size on stress generated in the stone. The analytical model for spherical stones is compared against a finite-difference model used to calculate stress in nonspherical stones. It is shown that at low frequencies, when the wavelength is much greater than the diameter of the stone, the maximum principal stress is approximately equal to the pressure amplitude of the incident wave. With increasing frequency, when the diameter of the stone begins to exceed about half the wavelength in the surrounding liquid (the exact condition depends on the material of the stone), the maximum stress increases and can be more than six times greater than the incident pressure. These results suggest that the BWL frequency should be elevated for small stones to improve the likelihood and rate of fragmentation.

Acoustic radiation forces can surround and trap objects to manipulate them in three dimensions. It has been demonstrated that the radiation forces can maneuver solid heavy objects similar to kidney stones in live animals under safe acoustic exposure levels. However, initial experiments identified limitations on the steering range of objects because of the array design, and tissue aberrations. Here, we present a method to design an in-house 256 multi-element array to improve the steering range of 2–5 mm stones. We modeled the acoustic field for various geometrical parameters including the element size, transducer focusing, and F-number at a frequency range from 0.5 to 1 MHz. The parameters were then used to simulate the trapping radiation forces on stone models to finalize the design of the array. The array was fabricated with a center frequency of 950 kHz and a focal distance located at 120 mm and an F-number of 1.5. A holography scan was performed to characterize the transducer output. Various trapping beams were measured and compared to simulations. The resulting radiation forces produced were on the order of the weight of the trapped 2-5 mm stone models. [Work supported by NIH P01-DK043881, K25-132416, and Applied Physics Laboratory SEED fellowship.]

Despite the growing incidence of urinary stones, the fundamental interventions for urinary stones have remained the same for several decades. However, technical innovations in ultrasound have enabled new strategies for stone management. Our team aims to employ these methods to establish a new paradigm to treat stones in an office or clinic rather than a surgical suite. Technologies include new imaging methods to detect and characterize stones, burst wave lithotripsy to fragment stones using focused ultrasound rather than shock waves, and ultrasonic propulsion to promote clearance of fragments, all using a single ultrasound platform. This presentation will describe the principles and development of these technologies, as well as the fruitful partnerships between teams of basic scientists, engineers, physicians, and industry that have enabled rapid development of these concepts to successful clinical trials. [Work supported by NIDDK P01 DK043881 and the Focused Ultrasound Foundation.]

INTRODUCTION AND OBJECTIVE:The purpose of the study is to test whether removing small, asymptomatic stones from the kidneys of patients being treated for kidney or ureteral stones will reduce recur...

INTRODUCTION AND OBJECTIVE:The feasibility of ultrasonic propulsion and burst wave lithotripsy (BWL) to noninvasively reposition distal ureteral stones to facilitate passage and relieve pain was te...

INTRODUCTION AND OBJECTIVE:We report stone comminution in the first human subjects by burst wave lithotripsy (BWL), which is the transcutaneous application of focused, cyclic ultrasound pulses.METH...

Liquid atomization and fountain formation by focused ultrasound was first published by Wood and Loomis [1]. Since then, the cavitation-wave hypothesis emerged to explain atomization in a fountain, which states atomization arises from a combination of surface capillary waves and the collapse of cavitation bubbles. More recently, high intensity focused ultrasound (HIFU) has been shown to fractionate tissue through either pulsed-cavitation or millisecond boiling histotripsy therapies; however it is unclear how millimeter-size boiling bubbles or cavitation bubble clouds fractionate tissue into submicron-size fragments. The objective of this work is to test the hypothesis experimentally that atomization and fountain formation occurs similarly in liquids and tissues and results in tissue erosion. A 2-MHz HIFU transducer operating at peak in situ pressures of 50 MPa and −11 MPa (linear intensity = 14,000 W/cm(2)) was focused at the interface between a liquid or tissue and air. A high-speed camera was used to monitor atomization and fountain formation in water, ethanol, glycerol, bovine liver, and porcine blood clots. The in situ linear intensity threshold for consistent atomization in one 10-ms pulse increased in the order: ethanol (180 W/cm(2)) < blood clot (250 W/cm(2)) < water (350 W/cm(2)) < liver (6200 W/cm(2)); glycerol did not atomize. Average jet velocities for the initial spray at the maximum acoustic intensity were similar for all materials and on the order of 20 m/s. The tissue erosion rate of liver approached saturation at around 300 10-ms pulses repeated at 1 Hz, which had an average erosion volume of 25.7±10.9 mm(3). While tissue atomization and fountain formation does not completely mimic what is observed in liquids, atomization provides a plausible explanation of how tissue is fractionated in millisecond boiling and possibly even cavitation cloud histotrispy therapies.

Boiling histotripsy (BH) is a High Intensity Focused Ultrasound (HIFU) method for precise mechanical disintegration of target tissue using millisecond-long pulses containing shocks. BH treatments with real-time ultrasound (US) guidance allowed by BH-generated bubbles were previously demonstrated ex vivo and in vivo in exposed porcine liver and small animals. Here, the feasibility of US-guided transabdominal and partially transcostal BH ablation of kidney and liver in an acute in vivo swine model was evaluated for 6 animals. BH parameters were: 1.5 MHz frequency, 5–30 pulses of 1–10 ms duration per focus, 1% duty cycle, peak acoustic powers 0.9–3.8 kW, sonication foci spaced 1–1.5 mm apart in a rectangular grid with 5–15 mm linear dimensions. In kidneys, well-demarcated volumetric BH lesions were generated without respiratory gating and renal medulla and collecting system were more resistant to BH than cortex. The treatment was accelerated 10-fold by using shorter BH pulses of larger peak power without affecting the quality of tissue fractionation. In liver, respiratory motion and aberrations from subcutaneous fat affected the treatment but increasing the peak power provided successful lesion generation. These data indicate BH is a promising technology for transabdominal and transcostal mechanical ablation of tumors in kidney and liver.

Purpose: Ultrasonic propulsion is an investigative modality to noninvasively image and reposition urinary stones. Our goals were to test safety and effectiveness of new acoustic exposure conditions from a new transducer, and to use simultaneous ureteroscopic and ultrasonic observation to quantify stone repositioning. Materials and Methods: During operation, ultrasonic propulsion was applied transcutaneously, whereas stone targets were visualized ureteroscopically. Exposures were 350 kHz frequency, ≤200 W/cm(2) focal intensity, and ≤3-second bursts per push. Ureteroscope and ultrasound (US) videos were recorded. Video clips with and without stone motion were randomized and scored for motion ≥3 mm by independent reviewers blinded to the exposures. Subjects were followed with telephone calls, imaging, and chart review for adverse events. Results: The investigative treatment was used in 18 subjects and 19 kidneys. A total of 62 stone targets were treated ranging in size from a collection of “dust” to 15 mm. Subjects received an average of 17 ± 14 propulsion bursts (per kidney) for a total average exposure time of 40 ± 40 seconds. Independent reviewers scored at least one stone movement ≥3 mm in 18 of 19 kidneys (95%) from the ureteroscope videos and in 15 of 19 kidneys (79%) from the US videos. This difference was probably because of motion out of the US imaging plane. Treatment repositioned stones in two cases that would have otherwise required basket repositioning. No serious adverse events were observed with the device or procedure. Conclusions: Ultrasonic propulsion was shown to be safe, and it effectively repositioned stones in 95% of kidneys despite positioning and access restrictions caused by working in an operating room on anesthetized subjects.

Introduction: Burst wave lithotripsy is an experimental technology to noninvasively fragment kidney stones with focused bursts of ultrasound (US). This study evaluated the safety and effectiveness of specific lithotripsy parameters in a porcine model of nephrolithiasis. Methods: A 6- to 7-mm human kidney stone was surgically implanted in each kidney of three pigs. A burst wave lithotripsy US transducer with an inline US imager was coupled to the flank and the lithotripter focus was aligned with the stone. Each stone was exposed to burst wave lithotripsy at 6.5 to 7 MPa focal pressure for 30 minutes under real-time image guidance. After treatment, the kidneys were removed for gross, histologic, and MRI assessment. Stone fragments were retrieved from the kidney to determine the mass comminuted to pieces

Remote acoustic manipulation of objects in three dimensions has been achieved through acoustic radiation forces imparted by designed acoustic beam traps. This technology can be used as a noninvasive medical tool to control foreign objects in the body. Success of this technology requires the ability to transmit complex beam shapes through the tissue while maintaining stable and robust acoustic traps. Vortex beams and other acoustic beam traps were synthesized using a 1.5 MHz, focused, multi-element array to trap and manipulate glass spheres mimicking stones. Measurements of the radiation forces agreed with calculations to within

The number and distribution of lung ultrasound (LUS) imaging artifacts—B-lines—is correlated with the presence of lung interstitial syndrome such as viral infection and pulmonary edema. The detection and quantification of B-lines is machine and operator dependent, and the mechanisms for B-line formation are not fully understood. The goals of this work were to collect RF data during LUS exams in patients with pulmonary edema and to compare to the signals and corresponding images simulated numerically to elucidate the B-line formation process. Verasonics ultrasound engine (VUE) with a phased array probe (4.5 MHz) was used to perform standard 10-zone LUS in ten patients with confirmed pulmonary edema. The RF data corresponding to each B-mode image and a series of 35 plane wave acquisitions were collected for off-line analyses. Finite element modeling of LUS pulse propagation was performed in COMSOL with fluid-filled inclusions of variable sizes and shapes in air-like medium simulating edematous lung areas. The B-mode image resulting from the simulated RF signals was reconstructed using VUE beamforming. The B-lines similar to those observed experimentally formed in simulated images only under specific conditions of sizes and shapes of water-filled areas relatively to LUS imaging wavelength. [Work supported by NIH R01EB023910.]

Burst wave lithotripsy (BWL) is a potential noninvasive treatment for breaking kidney stones. BWL requirements of high-pressure output, limited aperture for acoustic window, and specific focal length and frequency constrain the focal beam width. However, BWL is most effective only on stones smaller than the beam width. We tested a porous piezoelectric material (PZ36) to increase the output power and designed acoustic lenses that broaden the beam. A weighted iterative angular spectrum approach was used to calculate the source phase distribution needed to generate desired cross sectional focal beam profiles each of 12 mm width. The phase calculations were then 3D printed as holographic lenses placed over a circular aperture of 80-mm diameter, 350 kHz PZ36 to produce the desired beam at 85 mm depth. The difference in simulated beam width and that measured by hydrophone was

INTRODUCTION: A considerable publication record exists comparing sensitivity and specificity of radiological ultrasound (including point of care ultrasound) to computerized tomography for stone disease. However, the practical application of in-office ultrasound to support the growing number of kidney stone centers around the world represents a nuanced topic that is ripe for study and discussion. METHODS: We provide a descriptive analysis of how in-office ultrasound is being used as an adjunct to clinical care based on our experience during 50 days in clinic at an institutionally affiliated, multidisciplinary kidney stone center. Clinic subjects gave consent and underwent ultrasound as part of research studies. Ultrasonograms were shared with and verified by the treating physician before the patient was discharged from care. We counted the number of times research imaging altered the care plan. RESULTS: Of the 60 patients enrolled the clinician used the information obtained from the studies in 20 (33%) to determine the course of clinical care that resulted in a change in treatment or process. CONCLUSIONS: Ultrasound has the potential to be a cost-effective and valuable tool that can provide more efficient workflow within a kidney stone center or urology clinic.

Theoretical and numerical models were developed to calculate the polariscopic integrated light intensity that forms a projection of the dynamic stress within an axisymmetric elastic object. Although the model is general, this paper addressed its application to measurements of stresses in model kidney stones from a burst wave lithotripter for stone fragmentation. The stress was calculated using linear elastic equations, and the light propagation was modeled in the instantaneous case by integrating over the volume of the stone. The numerical model was written in finite differences. The resulting images agreed well with measured images. The measured images corresponded to the maximum shear stress distribution, although other stresses were also plotted. Comparison of the modeled and observed polariscope images enabled refinement of the photoelastic constant by minimizing the error between the calculated and measured fields. These results enable quantification of the stress within the polariscope images, determination of material properties, and the modes and mechanisms of stress production within a kidney stone. Such a model may help in interpreting elastic waves in structures, such as stones, toward improving lithotripsy procedures.

INTRODUCTION AND OBJECTIVE:Our goals were to validate stone comminution with an investigative clinical burst wave lithotripsy (BWL) system and to evaluate the use of ultrasonic propulsion to move t...

INTRODUCTION AND OBJECTIVE:Artificial stone models are used in lithotripsy research. While the value of models is their availability and reproducibility in shape and characteristics, a challenge re...

INTRODUCTION AND OBJECTIVE:The color Doppler ultrasound twinkling artifact, which highlights kidney stones with rapidly changing color, has been shown to increase the sensitivity and specificity of...

Purpose of review Burst wave lithotripsy and ultrasonic propulsion of kidney stones are novel, noninvasive emerging technologies to separately or synergistically fragment and reposition stones in an office setting. The purpose of this review is to discuss the latest refinements in technology, to update on testing of safety and efficacy, and to review future applications. Recent findings Burst wave lithotripsy produced consistent, small passable fragments through transcutaneous applications in a porcine model, while producing minimal injury and clinical trials are now underway. A more efficient ultrasonic propulsion design that can also deliver burst wave lithotripsy effectively repositioned 95% of stones in 18 human participants (18 of 19 kidneys) and clinical trials continue. Acoustic tractor beam technology is an emerging technology with promising clinical applications through the manipulation of macroscopic objects. Summary The goal of the reviewed work is an office-based system to image, fragment, and reposition urinary stones to facilitate their natural passage. The review highlights progress in establishing safety, effectiveness, and clinical benefit of these new technologies. The work is also anticipating challenges in clinical trials and developing the next generation of technology to improve on the technology as it is being commercialized today.

Introduction: Studies suggest that the width of the acoustic shadow on ultrasound (US) more accurately reflects true stone size than the stone width in US images. We evaluated the need for training in the adoption of the acoustic shadow sizing technique by clinical providers. Methods: Providers without shadow sizing experience were recruited and assigned in a stratified, alternating manner to receive a training tutorial (“trained”) or no intervention (“control”). Each conducted a baseline assessment of 24 clinical US images; where present, shadow width was measured using custom calipers. The trained group subsequently completed a standardized training module on shadow sizing. All subjects repeated measurements after ∼1 week. Group demographics were compared using Fisher's exact test. Measurements were compared to clinically reported stone sizes on corresponding CT and US using mixed-effects models. One millimeter concordance between shadow and CT size was compared using a generalized linear mixed-effects model. Results: Twenty-six subjects were included. There was no significant difference between groups in demographics, clinical role, or US experience. Mean reported CT and US stone sizes were 6.8 ± 4.0 mm and 10.3 ± 4.1 mm, respectively. At baseline, there was no difference in shadow size measurements between groups (p = 0.18), and shadow size was no more accurate than US stone size (p = 0.28 trained; p = 0.81 control), compared to CT. After training, overestimation bias of shadow size in the trained group decreased to 1.6 ± 0.5 mm (p

Combined laboratory experiment and numerical simulation are conducted on bubble clouds nucleated on the surface of a model kidney stone to quantify the energy shielding of the stone caused by cavitation during burst wave lithotripsy (BWL). In the experiment, the bubble clouds are visualized and bubble-scattered acoustics are measured. In the simulation, a compressible, multi-component flow solver is used to capture complex interactions among cavitation bubbles, the stone, and the burst wave. Quantitative agreement is confirmed between results of the experiment and the simulation. In the simulation, a significant shielding of incident wave energy by the bubble clouds is quantified. The magnitude of shielding can reach up to 90% of the energy of the incoming burst wave that otherwise would be transmitted into the stone, suggesting a potential loss of efficacy of stone comminution. There is a strong correlation between the magnitude of the energy shielding and the amplitude of the bubble-scattered acoustics, independent of the initial size and the void fraction of the bubble cloud within a range addressed in the simulation. This correlation could provide for real-time monitoring of cavitation activity in BWL.

Purpose: Burst wave lithotripsy (BWL) is a new technology in development to fragment urinary stones. Ultrasonic propulsion (UP) is a separate technology under investigation for displacing stones. We measure the effect of propulsion pulses on stone fragmentation from BWL. Materials and Methods: Two artificial stone models (crystalline calcite, BegoStone plaster) and human calcium oxalate monohydrate (COM) stones measuring 5 to 8 mm were subjected to ultrasound exposures in a polyvinyl chloride tissue phantom within a water bath. Stones were exposed to BWL with and without propulsion pulses interleaved for set time intervals depending on stone type. Fragmentation was measured as a fraction of the initial stone mass fragmented to pieces smaller than 2 mm. Results: BegoStone model comminution improved from 6% to 35% (p

Feasibility of ultrasonic propulsion and burst wave lithotripsy (BWL) to noninvasively reposition distal ureteral stones to facilitate passage and relieve pain was tested. Patients presenting to the clinic or emergency department were recruited. Thirteen subjects underwent ultrasonic propulsion (lower amplitude, longer duration pulses) alone, and 10 subjects also received intermittent BWL (higher amplitude, shorter duration pulses). All participants were awake and underwent a pain assessment pre- and post-procedure. For analysis, subjects were sub-categorized based on whether their stone was acute or chronic (present for ≤10 days or >10 days from their initial ED or symptomatic presentation, respectively). Seventeen subjects were enrolled in the acute study population and 6 subjects were enrolled in the chronic population. Overall, 94% of acute stones passed in an average of 3.4 days post-procedure relative to 54% in 7.5 days in the American Urological Association guidelines. 67% of chronic cases passed stones or fragments, and two surgeries were cancelled. Pain reduction was statistically significant ( p = 0.0215). Adverse events were limited to hematuria on initial urination post-procedure (BWL only, n = 3) and a mild sensation, akin to a pinprick, associated with fewer than 10 of 620 propulsion bursts ( n = 3). [Work supported by NIH-P01-DK04331.]

Acoustic radiation forces can trap and manipulate objects in three-dimensional space (3D). The state of the art in acoustic trapping has demonstrated the ability to move small or lightweight objects using single or multiple transducers. For certain medical applications, acoustic manipulation can be utilized to control foreign objects in the body, such as kidney stones. However, difficulties from these applications include the ability to control large solid objects, transmitting robust acoustic beams through the skin, and the use of a single source due to limited acoustic window in the body. The goal of this work was to use a 1.5 MHz, focused, multi-element array to synthesize specific acoustic beams to trap, levitate, and steer kidney stone models (glass spheres) in a water bath and urinary bladders of live pigs. Stable acoustic traps were investigated numerically and experimentally in water bath to design a protocol for the 3D manipulation strategies used invivo . Three programmed path were used to levitate and manipulate glass spheres in live pigs. The motion was recorded using a camera and a synchronized ultrasound imaging probe. Deviation from the intended paths was on average