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.

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•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.