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PREVENTATIVE ULTRASONIC DETECTION AND
EXPULSION OF KIDNEY STONES
Julianna C. Simon*, Lawrence A. Crum, Stephen J. Carter1, Michael R. Bailey, Oleg A. Sapozhnikov2,
Bryan W. Cunitz, Lisa Norton4, Jonathan Harper3
Center for Industrial and Medical Ultrasound, Applied Physics Laboratory,
University of Washington, 1013 NE 40th Seattle, WA 98105 USA1Radiology, University of Washington 3Urology, University of Washington *Student Presenter2Physics, Moscow State University 4Center for Commercialization, University of Washington
Stone Detection
Ultrasound Detection and Expulsion of Stones
AcknowledgmentsThe authors thank our collaborators at the Center for Industrial
and Medical Ultrasound. Work supported by the National Space
Biomedical Research Institute through NASA NCC 9-58 and by
National Institutes of Health (DK43881, DK086371).
Status
U.S. Patents pending
IRB approval for clinical trial of stone detection
Pre-IDE meeting scheduled for clinical trial on expulsion
Won business plan competition at University of Washington
Invited to present in Urology course and AUA annual meeting
Acquired additional funding from UW Commercialization
foundations and the National Institutes for Health.
Current plan is to conduct clinical trial before starting company
or licensing the technology.
References
Shah A, Harper JD, Cunitz BW, Wang YN, Paun M, Simon JC, Lu W,
Kaczkowski PJ, Bailey MR, “Focused ultrasound to expel calculi
from the kidney,” J Urol (submitted).
A. Shah, N.R. Owen, W. Lu, B.W. Cunitz, P.J. Kaczkowski, J. Harper,
M.R. Bailey, “Novel ultrasound method to reposition kidney stones,”
Urol Res (2010) 38:491-495.
Safety
Extensive animal studies have been and are being conducted
to test the safety of stone repositioning. No injury has been
observed at levels used in stone movement.
Project Aims
NSBRI project “Smart therapeutic ultrasound device for mission
critical medical care.”
•To develop a smart medical device that would be lightweight,
portable, FDA-approved, commercially produced, and capable
of addressing a variety of risks described in the Human
Research Program Integrated Research Plan.
•To be based upon the platform technology of ultrasound and
would not require high skill levels from the user.
In particular, we seek to address:
(Human Research Program Integrated Research Plan)
Risk 105:… possibility of penetrating trauma to the crew ….
Risk 108:…possibility the crew will need abdominal surgery …
Risk 14:… possibility for increased cancer morbidity or mortality.
Risk 21:…possibility that symptomatic renal stones….
Risk 87:…increased probability of renal calculi formation …
(Space Medicine Exploration Medical Condition List)
Kidney stones: Shall for Lunar Sortie and Outpost
Shall for contingencies for ISS, Sortie, and Outpost
•Prototype made from Verasonics Ultrasound Engine, a COTS
open architecture, software based ultrasound platform.
•Uses Philips/ATL diagnostic probes C4-2 and P4-2 on ISS now.
•Suitable platform for other NSBRI/ NASA ultrasound technology.
•VUE is radiation hardened. Working with NASA Glenn to
implement it with flight-ready IBM Lenovo ThinkPad laptop.
SMST01601
Fig. 1. A smart medical device can be
constructed that utilizes a portable diagnostic
ultrasound scanner for detection and targeting of
such critical medical risks as internal bleeding,
malignant tumors, and renal calculi that are
present in the collecting system of the kidney or
obstructing the ureter. Combining this imaging
system with a therapeutic transducer that utilizes
High Intensity Focused Ultrasound (HIFU), it is
possible to perform non-invasive image-guided
therapy of these conditions.
Fig. 3. Diagnostic Probe
Stone Expulsion
The same instrument and user interface then moves the stone with acoustic
radiation force out of the kidney so it will pass naturally.
Fig. 6. With a near vertical c-arm, (a) full-view retrograde
pylogram of the right kidney with the pig in a supine
position and (b) enlarged super-imposed frames of a
fluoroscopic movie with the pig on its left side. The image
in (a) is intended to provide some orientation for the image
in (b) which shows through super-imposed images the
ultrasonic expulsion of a bead. The traced plane in (a)
represents the projection of (a) that appears in (b). In both
images, the thick black line and arrow indicate a
stationary large bead implanted in the major calyx. The
white line in both traces the path of the expelled bead. The
fluoroscopic image in (b) shows the 5-mm bead moved at
least 3 cm in 1.1 s traveling from the lower pole through
the UPJ into the canalized ureter through which the bead
was originally implanted.
Fig. 8. Maximum acoustic output from the device
available to reposition stones is more than diagnostic
ultrasound but less than lithotripsy. However, it still
may have some capability to comminute stones.
Fig. 4. A) Power Doppler image of a “twinkling” kidney stone and
laminar blood flow. B) Power Doppler image optimized for stone
detection.
Stone Tracking
The system tracks and displays the stone movement in real time.
More intense and longer pulses were used to define thresholds
for injury above those used in this device.
0
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0 2000 4000 6000 8000 10000 12000 14000 16000
Inju
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Per
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Acoustic Intensity I_SPPA (W/cm2)
Injury at 100% Duty Cycle
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0 5000 10000 15000 20000 25000 30000 35000
Inju
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Acoustic Intensity I_SPPA (W/cm2)
Injury at 2% Duty Cycle
•New algorithm written to detect kidney
stones with ultrasound.
•User friendly – stone marked in color on
display
•Removes confusion of colored blood
vessels on screen
Image quality not stastically different from the image of the HDI-5000 (same
system that is currently on ISS) in side-by-side comparison by clinicians.
Fig. 9. Injury incidence at different acoustic intensities for continuous ultrasound exposure (left) and
pulsed ultrasound (right) at a duty cycle similar to that used in stone expulsion.
Fig. 10. Hematoxylin and eosin and nicotinamide adenine dinucleotide-diaphorase stained sections
of pig kidney (left) not exposed to ultrasound (center) exposed to levels used in the ultrasonic
propulsion of stones, and (right) exposed
to levels above those used for stone
propulsion. Injury, thermal coagulation
of tissue, was only observed in image
(right) and in 6 of 7 samples treated
with this exposure. No injury was
observed in any other samples. NADH-d
stain indicates viable and non-viable
tissue as blue/purple and no stain
respectively. The bar represents 100 µm.
Fig.2. Prototype
Fig. 5. Screenshots of system. (Upper) Imaging
screen – the stone is indicated with color in the
image. (Lower) Touch control screen shows the
user controls.
Fig. 7. (a) The user specifies a region of interest that includes the stone. (b) A speckle tracking algorithm updates the
location of the stone as it is pushed. (c) The bounding box is color-coded to report the algorithm’s confidence in the
new position of the stone, which assists the user during manual pushing or during automated adaptive pushing. Here
the stone was moved 1.5 cm in 1 s in vivo.
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