In-vitro assessment of a new portable ballistic lithotripter with percutaneous and ureteroscopic models.

BACKGROUND AND PURPOSE: The EMS Swiss LithoBreaker is a new, portable, electrokinetic lithotripter. We compared its tip velocity and displacement characteristics with a handheld, pneumatic lithotripter LMA StoneBreaker.™ We also evaluated fragmentation efficiency using in vitro models of percutaneous and ureteroscopic stone fragmentation. MATERIALS AND METHODS: Displacement and velocity profiles were measured for 1-mm and 2-mm probes using a laser beam aimed at a photo detector. For the percutaneous model, 2-mm probes fragmented 10-mm spherical BegoStone phantoms until the fragments passed through a 4-mm mesh sieve. The ureteroscopic model used 1-mm probes and compared the pneumatic and electrokinetic devices to a 200-µm holmium laser fiber. Cylindrical (4-mm diameter, 4-mm length) BegoStone phantoms were placed into silicone tubing to simulate the ureter; fragmented stones passed through a narrowing in the tubing. RESULTS: For both 1-mm and 2-mm probes, the electrokinetic device had significantly higher tip displacement and slower tip velocity, P<0.01. In the percutaneous model, the electrokinetic device needed an average of 484 impulses over 430 seconds to fragment one BegoStone, while the pneumatic device needed 29 impulses over 122 seconds to fragment one stone. Both clearance times and number of impulses needed for percutaneous stone clearance were significantly different at P<0.01. Ureteroscopically, the mean clearance time was 97 seconds for the electrokinetic lithotripter, 145 seconds for the pneumatic lithotripter, and 304 seconds for the laser. Comparing the pneumatic device with the electrokinetic device ureteroscopically, there was no significant difference in clearance time, P=0.55. Both the pneumatic and electrokinetic lithotripters, however, demonstrated decreased clearance times compared with the laser, P=0.027. CONCLUSIONS: The portable electrokinetic lithotripter may be better suited for ureteroscopy instead of percutaneous nephrolithotomy. It appears to be comparable to the portable pneumatic device in the ureter. Further clinical studies are needed to confirm these findings in vivo.

A composite kidney stone phantom with mechanical properties controllable over the range of human kidney stones.

A novel composite kidney stone phantom has been developed. This stone phantom is producible with mechanical properties mimicking the range of tensile fracture strength and acoustic properties of human kidney stones and is an inorganic/organic composite material, as are natural kidney stones. Diametral compression testing was used to measure tensile fracture strength, which determines the acoustic comminution behavior of kidney stones. Ultrasound transmission tests were made to characterize the acoustic properties of these stone phantoms. Both the tensile fracture strength (controllable from 1 to approximately 5 MPa) and acoustic properties (C(L) = 2700-4400 m/s and C(T)=1600-2300m/s) of these composite phantom stones match those of a wide variety of human kidney stones. These artificial stone phantoms should have wide utility in lithotripsy research.

The use of chemical treatments for improved comminution of artificial stones.

PURPOSE: The acoustic and mechanical properties of various stone compositions are significantly different and thus result in varying degrees of fragility. Consequently, results to shock wave lithotripsy (SWL) are influenced accordingly. We report the results of a study of fragility of various stone compositions, and the influence on each stone's baseline physical properties and fragility when exposed to various chemolytic solutions. MATERIALS AND METHODS: Before SWL artificial stones of differing compositions were irrigated with various chemolytic solutions. Calcium oxalate monohydrate (COM) stones were treated with ethylenediaminetetraacetic acid (EDTA), stones composed of magnesium ammonium phosphate hydrogen were treated with hemiacidrin, and stones made of uric acid (UA) were treated with tromethamine. Synthetic urine served as a control for all stone groups. Using an ultrasound transmission technique, longitudinal wave propagation speed was measured in all groups of artificial stones. Stone density was also measured by using a pycnometer (based on Archimedes' principle). Based on these measurements transverse (shear) wave speed (assuming a constant Poisson's ratio), wave impedance and dynamic mechanical properties of the artificial stones were calculated. Moreover, the microhardness of these artificial stones was measured, and fragility testing using SWL with and without pretreatment with the previously mentioned chemolytic solutions, was performed. RESULTS: Wave speed, wave impedance, dynamic mechanical properties and microhardness of EDTA treated COM stones and tromethamine treated UA stones were found to decrease compared to untreated (synthetic urine) control groups. The suggestion that chemolytic pretreatment increases stone fragility was verified by the finding of increased stone comminution after SWL testing. Combining this medical pretreatment and SWL, the findings demonstrate a significant impact of various solvents on stone comminution, in particular EDTA treated COM stones, tromethamine treated UA stones and hemiacidrin treated magnesium ammonium phosphate hydrogen stones. These data suggest that by altering the chemical environment of the fluid surrounding the stones it is possible to increase the fragility of renal calculi in vitro. CONCLUSIONS: These results indicate that appropriate chemical treatments may provide a useful adjunctive modality for improving the efficacy of stone comminution during shock wave lithotripsy.

Recent developments in SWL physics research.

Two projects in our laboratory highlight some recent developments in shockwave lithotripsy (SWL) physics research. In the first project, we developed a prototype of a piezoelectric annular array (PEAA) shockwave generator that can be retrofitted on a Dornier HM-3 lithotripter for active control of cavitation during SWL. The PEAA generator, operating at 15 kV, produces a peak positive pressure of approximately 8 MPa with a -6-dB beam diameter of 5 mm. The shockwave generated by the PEAA was used to control and force the collapse of cavitation bubbles induced by a laboratory electrohydraulic shockwave lithotripter with a truncated HM-3 reflector. With optimal time delay between the lithotripter pulse and the PEAA-generated shockwave, the collapse of cavitation bubbles near the stone surface could be intensified, and the resultant stone fragmentation in vitro could be significantly improved. In the second project, high-speed shadowgraph imaging was used to visualize the dynamics of lithotripter-induced bubble oscillation in a vascular phantom. Compared with the free bubble oscillation in water, the expansion of cavitation bubble(s) produced in silicone tubes and a 200-microm cellulose hollow fiber by either a Nortech EHL or a Dornier XL-1 lithotripter was found to be significantly constrained. Rupture of the cellulose hollow fiber was observed consistently after about 20 shocks from the XL-1 lithotripter at an output voltage of 20 kV. These results confirm experimentally that SWL-induced cavitation in vivo can be significantly constrained by the surrounding tissue, and large intraluminal bubble expansions could cause rupture of capillaries and small blood vessels.

Transient cavitation and acoustic emission produced by different laser lithotripters.

Transient cavitation and shockwave generation produced by pulsed-dye and holmium:YAG laser lithotripters were studied using high-speed photography and acoustic emission measurements. In addition, stone phantoms were used to compare the fragmentation efficiency of various laser and electrohydraulic lithotripters. The pulsed-dye laser, with a wavelength (504 nm) strongly absorbed by most stone materials but not by water, and a short pulse duration of approximately 1 microsec, induces plasma formation on the surface of the target calculi. Subsequently, the rapid expansion of the plasma forms a cavitation bubble, which expands spherically to a maximum size and then collapses violently, leading to strong shockwave generation and microjet impingement, which comprises the primary mechanism for stone fragmentation with short-pulse lasers. In contrast, the holmium laser, with a wavelength (2100 nm) most strongly absorbed by water as well as by all stone materials and a long pulse duration of 250 to 350 microsec, produces an elongated, pear-shaped cavitation bubble at the tip of the optical fiber that forms a vapor channel to conduct the ensuing laser energy to the target stone (Moss effect). The expansion and subsequent collapse of the elongated bubble is asymmetric, resulting in weak shockwave generation and microjet impingement. Thus, stone fragmentation in holmium laser lithotripsy is caused primarily by thermal ablation (drilling effect).

Controlled, forced collapse of cavitation bubbles for improved stone fragmentation during shock wave lithotripsy.

The feasibility of using controlled, forced collapse of cavitation bubbles for improved stone fragmentation during shock wave lithotripsy was demonstrated using microsecond tandem shockwave pulses. High-speed photography revealed that a secondary shock wave, released in less than 500 microseconds (microsec.) following a lithotripter-generated shock wave, can be used to control and force the collapse of cavitation bubbles toward target concretions. This timely enforced shockwave-bubble interaction was found to greatly enhance the cavitational activity near the stone surface, with a resultant up to 43% increment in stone fragmentation. Since most of the cavitation energy is directed and concentrated toward the target stones and fewer shock waves are needed for successful stone comminution, tissue injury associated with this new lithotripsy procedure may also be reduced. This novel concept of shock wave lithotripsy may be used to improve the treatment efficiency and safety of existing clinical lithotripters, as well as in the design of new shock wave lithotripters.

Inertial cavitation and associated acoustic emission produced during electrohydraulic shock wave lithotripsy.

The inertial cavitation and associated acoustic emission generated during electrohydraulic shock wave lithotripsy were studied using high-speed photography and acoustic pressure measurements. The dynamics of cavitation bubble clusters, induced in vitro by an experimental laboratory lithotripter, were recorded using a high-speed rotating drum camera at 20,000 frames/s. The acoustic emission, generated by the rapid initial expansion and subsequent violent collapse of the cavitation bubbles, was measured simultaneously using a 1-MHz focused hydrophone, The expansion duration of the cavitation bubble cluster was found to correlate closely with the time delay between the first two groups of pressure spikes in the acoustic emission signal. This correlation provides an essential physical basis to assess the inertial cavitation produced by a clinical Dornier HM-3 shock wave lithotripter, both in water and in renal parenchyma of a swine model. In the clinical output voltage range (16-24 kV), the expansion duration of the primary cavitation bubble cluster generated by the HM-3 lithotripter in water increases from 158 to 254 microseconds, whereas the corresponding values in renal parenchyma are much smaller and remain almost unchanged (from 71 to 72 microseconds). In contrast, subsequent oscillation of the bubble following its primary collapse is significantly prolonged (from 158-235 microseconds in water to 1364-1373 microseconds in renal parenchyma). These distinctive differences between lithotripsy-induced inertial cavitation in vitro and that in vivo are presumably due to the constraining effect of renal tissue on bubble expansion.

Transient oscillation of cavitation bubbles near stone surface during electrohydraulic lithotripsy.

Using high-speed photography and acoustic emission measurements, we studied the dynamics of a transient cavitation bubble near a stone surface and the concomitant shockwaves generated during electrohydraulic lithotripsy (EHL). At each spark discharge, a vapor plasma and subsequently a cavitation bubble oscillating around the tip of an EHL probe are produced. Simultaneously, three distinctive shockwave pulses are generated. The first shockwave is produced by the rapid expansion of the vapor plasma, while the second and third waves are produced by rebounds of the cavitation bubble. Depending on the proximity of the probe to the stone surface, the collapse of the cavitation bubble may be symmetric, resulting in a strong shockwave emission; or asymmetric, leading to the formation of a liquid jet. For the Nortech AUTOLITH lithotripter with a 1.9F probe that was used in this study, maximum shockwave emission is produced when the probe is about 1 mm from the stone surface, whereas the maximum jet velocity is produced when the probe tip is at distance equivalent to the maximum bubble radius of about 3 mm. These findings are consistent with clinical experience, which suggests that for optimal treatment results, the EHL probe should be placed close to the stone surface.

A novel variable-gravity simulation method: potential for astronaut training.

Zero gravity conditions for astronaut training have traditionally used neutral buoyancy tanks, and with such tanks hypogravity conditions are produced by the use of supplemental weights. This technique does not allow for the influence of water viscosity on any reduced gravity exercise regime. With a water-foam fluid produced by using a microbubble air flow together with surface active agents to prevent bubble agglomeration, it has been found possible to simulate a range of gravity conditions without the need for supplemental weights and additionally with a substantial reduction in the resulting fluid viscosity. This new technique appears to have application in improving the simulation environment for astronaut training under the reduced gravity conditions to be found on the moon or on Mars, and may have terrestrial applications in patient rehabilitation and exercise as well.

Edge targeting reduces the number of shock waves required for biliary ESWL in vitro.

In vitro experiments were conducted to determine if differences in targeting would effect stone fragmentation. Ten pairs of twin gallstones were used. The stones in each pair were identical in volume, diameter, radiolucency, and gross shape. One stone from each pair was subjected to shock waves focused at the center of the stone; the other was treated with shock waves targeted at the edge. Lithotripsy was terminated when all fragments were less than 5mm in diameter. The total number of shock waves used for each stone was recorded. In 7 of 10 pairs, fewer shock waves were required to fragment the edge targeted stone than the center targeted stone. In two of the remaining three pairs, equal numbers of shock waves were required for complete fragmentation. The difference between edge targeting and center targeting was shown to be statistically significant using the nonparametric Wilcoxin Signed Rank Test. (1 tailed = p less than 0.02, 2 tailed = p less than 0.04). These findings suggest that the outcome of biliary lithotripsy may be improved by targeting the edge of the stone.

Would revision arthroplasty be facilitated by extracorporeal shock wave lithotripsy? An evaluation including whole bone strength in dogs.

Extracorporeal shock-wave lithotripsy has been proposed as a modality to facilitate the removal of bone cement during revision arthroplasty; however, concomitant cortical microfractures have been reported. The current study examines the effect on whole bone strength of extracorporeal shock-wave lithotripsy directed at the cement-bone complex. Canine femora were subjected to manual cement extraction or lithotripsy followed by manual cement extraction. Contralateral femora served as controls. Torsional fractures were created, and maximum torque, maximum angular displacement, and energy capacity to failure were determined. Although cement extraction alone reduced mean torque by 6.6% and failed to reduce mean torque angle or mean energy capacity, the combination of lithotripsy and cement extraction reduced mean torque by 7.3%, mean torque angle by 14.3%, and mean energy capacity by 18.3%. No statistical significance was demonstrated between the two groups in torque, angle, or energy capacity. At magnitudes and numbers of shock waves previously shown to significantly reduce cement-bone interface mechanical strength, lithotripsy exposure had a minimal and insignificant effect on whole bone strength.

Mechanical property studies of human gallstones.

The recent development of gallstone fragmentation methods has increased the significance of the study of the mechanical properties of human gallstones. In the present work, fracture strength data and microhardness values of gallstones of various chemical compositions are presented as tested in both dry and simulated bile environments. Generally, both gallstone hardness and fracture strength values were significantly less than kidney stone values found in previous studies. However, a single calcium carbonate stone was found to have an outer shell hardness exceeding those values found for kidney stones. Diametral compression measurements in simulated bile conclusively demonstrated low gallstone fracture strength as well as brittle fracture in the stones tested. Based on the results of this study, one may conclude that the wide range of gallstone microhardnesses found may explain the reported difficulties previous investigators have experienced using various fragmentation techniques on specific gallstones. Moreover, gallstone mechanical properties may be relatively sensitive to bile-environment composition.

Experimental laboratory lithotripter: design, construction, and operation.

A laboratory lithotripter has been constructed and used to comminute (crush to a powder) both kidney stones and gallstones. The stones are placed in the second focus (f2) of an ellipse of revolution whose linear eccentricity is 4.7 cm and then acoustically shocked an average of 200 times by an underwater spark discharge at the first focus (f1). The energy levels available from the capacitors (3 to 52 joules) of this unit extend below and above the range of commercially available clinical devices. The electrical and mechanical design of this unit is presented. At a relatively low cost (approximately $15,000) the unit appears to have considerable application in non-clinical research in lithotripsy. Quantitative results of the application of this device to the comminution of human kidney stones are presented.

Extracorporeal shock wave lithotripsy: the use of chemical treatments for improved stone comminution.

Extracorporeal shock wave lithotripsy (ESWL) can require more than two thousand acoustic shocks to achieve an adequate degree of renal calculus comminution. A decrease in the number of shocks necessary for effective treatment offers both technical and clinical benefits. The results presented here demonstrate that it is possible in particular cases to increase substantially the degree of comminution produced using a fixed number of acoustic impulses by exposing the stones to solutions of controlled pH and chemical composition during acoustic shock treatment. The largest increase in comminution was observed for magnesium ammonium phosphate hexahydrate/apatite stones exposed to citrate solutions. The smaller particle sizes are shown to result not only from stone dissolution but also from an increase in the ease of stone fracture during acoustic shocking. The degree of comminution of the largest fragment sizes was also found to be slightly increased for calcium oxalate stones by exposure to synthetic urine of elevated pH. These chemical methods of increased stone comminution appear to be directly applicable to particular cases and may have general clinical utility if suitable conditions affecting all stones can be found.

Effect of pH on the microhardness of renal calculi.

The effects of synthetic urine environments of pH 4, 6, and 9.5 on the microhardness of renal calculi have been investigated. Tests were made, using both Vickers and Knoop indenters, on three compositions of calculi: 100% calcium oxalate monohydrate (whewellite), 100% uric acid, and 98% magnesium ammonium phosphate hexahydrate (struvite) mixed with 2% carbonate apatite. Whewellite calculi hardness was lowered, relative to (dry) values by 45-55% when saturated with a solution of pH 9.5. Exposure to lower pH conditions was not as effective in lowering hardness in this case. Struvite calculi hardness was lowered by 41-52% compared to the dry hardness and uric acid calculi hardness decreased by 25-36%, compared to dry hardnesses. For uric acid stones the reduction in hardness did not depend on pH within the range of pH values investigated. For struvite stones, acid pH conditions appear to give an increased softening, compared to other pH values.

Measurement of in vivo corrosion rates in baboons, and correlation with in vitro tests.

The Lineal Polarization Technique was used to determine the polarization resistances and corrosion currents of various dental restorative and implant alloys and amalgams placed in the teeth of animals, and as laboratory samples in artificial saliva. Gold- and chromium-containing alloys corroded the least, and amalgams generated the highest corrosion currents. There was good agreement between measurements made in vivo and in vitro. This is the first time that corrosion current have been measured in the mouth repeatedly over a long time span. These methods may be developed into useful predictive tests of in vivo corrosion.

Corrosion behavior of Au and Ag modified Cu-Ni-Mn alloys.

The linear electrochemical polarization method was used to provide quantitative in vitro measurements of corrosion rates as a function of exposure time for Cu-Ni-Mn, Cu-Ni-Mn-Au, Cu-Ni-Mn-Ag, and Cu-Ni-Mn-Au-Ag alloys in artificial saliva. Both Au and Ag additives to dental-cast Cu-Ni-Mn alloys lowered the corrosion rate significantly.