System and method for tissue change monitoring during HIFU

System and method for tissue change monitoring during HIFU
US008235902B2
(12) Ulllted States Patent
(10) Patent N0.:
Chen et al.
US 8,235,902 B2
(45) Date of Patent:
(54) SYSTEM AND METHOD FOR TISSUE
i
,
,
Aug. 7, 2012
zDorg/r
Ite
1
1 et a .
CHANGE MONITORING DURING HIFU
TREATMENT
4,174,634 A
4,183,249 A
4,207,901 A
(75) Inventors: Wo-Hsing Chen, Fishers, IN (US); Roy
4,209,022 A
Carlson, New Palestine, IN (US); Clint
2
giman
C. Weis, Greenwood, IN (US); Ralf
4’227’417 A
“M980 G132
Seip, Indianapolis, IN (Us); Narelldra
T. Sanghvi, Indianapolis, IN (US)
4,231,373 A
4,241,412 A
11/1980 Waxman et a1.
12/1980 Swain
4,241,610 A
12/1980 Anderson
(73) Assignee: Focus Surgery, Inc., Indianapolis, IN
4,248,090 A
Us
(
(*)
Notice:
)
Subject to any disclaimer, the term ofthis
patent is extended or adjusted under 35
11/1979 Dory
1/1980 Anderson
6/1980 Nigam
6/1980 Dory
2/1981 Glenn
4,257,271 A
3/1981 Glenn
4,274,421 A
6/1981 Dory
4,274,422 A
6/1981 Anderson et al.
4,231,661 A
4,290,310 A
8/1931 Dory
9/1981 Anderson
U.S.C. 154(b) by 1273 days.
(Continued)
(21) Appl. No.: 11/853,191
FOREIGN PATENT DOCUMENTS
CA
(
22
)
F1 d:
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(65)
(51)
S
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Us 2009/0069677 A1
Int Cl
10/1994
.
’
(Continued)
Prior Publication Data
A 6}B /00
OTHER PUBLICATIONS
Man 12’ 2009
R. Seip, et al., “Sonablate® 500: A Novel Platform for Transrectal
Image-Guided HIFU Treatment of Localized Prostate Cancer,” pre
(2006 01)
sented at the 32nd Annual Symposium of the Ultrasonic Industry
'
(52)
(58)
1332441
. 11 2007
Association (UIA), Oct. 2002, 28 pgs.
US. Cl. ....... .. 600/439; 600/407; 600/437; 600/427
Field of Classi?cation Search ................ .. 600/407,
600/437, 439, 471
See application ?le for complete search history.
(cominll?d)
_
_
P1’lmary Examme" * Tse Chen
Assistant Examiner * Joel F Brutus
(56)
References Cited
(74) Attorney, Agent, or Firm 4 William J. McNichol, Jr.;
Reed Smith LLP
U.S. PATENT DOCUMENTS
4,005,258 A
1/1977 Dory
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4,012,952 A
4,063,451 A
(57)
1/1977 Beaver
3/1977 Dory
12/1977 Dory
4,074,564 A
2/1978 Anderson
4,084,582 A
4/1978 Nigam
ABSTRACT
A method and apparatus is disclosed for determining the
presence of tissue change due to exposure to HIFU Therapy.
18 Claims, 16 Drawing Sheets
300
ACQUIRE BEFORE
IMAGE
M
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DETERMINE R01 IN
EEEoRE IMAGE
M
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ACQUIRE AFTER
IMAGE
M
DETERMINE ROI IN
AFTER IMAGE
M
I
DETERMINE
PARAMETER
REPRESENTATIVE 0F
LEVEL OF TISSUE
CHANGE BETWEEN
BEFORE IMAGE AND
AFTER IMAGE
m
l
PROVIDE VISUAL
INDICATION OF
LEVEL OF TISSUE
CHANGE ON DISPLAY
312
US 8,235,902 B2
Page2
US. PATENT DOCUMENTS
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W0 01/28623 A2
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12/1998
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US 8,235,902 B2
Page 3
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WO 2005/107601
2006119572
2006129099
2007102161
A3
A2
A3
A2
A2
A2
A1
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the Treatment of Localized Prostate Cancer,” International Sympo
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R. Seip, et al., “High-Intensity Focused Ultrasound (HIFU) Phased
Arrays: Recent Developments in Transrectal Transducers and Driv
ing Electronics Design,” Third International Symposium on Thera
peutic Ultrasound, Lyon, France, Jun. 2003, 6 pgs.
R. Seip, et al., “High-Intensity Focused Ultrasound (HIFU) Phased
Arrays: Recent Developments in Transrectal Transducers and Driv
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K. Ishida, et al., “Development and animal experiment of variable
focusing HIFU system for prostate cancer treatment,” Proc. of the
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focusing HIFU system for prostate cancer treatment,” Proc. of the
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R. Seip, et al., “Annular and Cylindrical Phased Array Geometries for
Transrectal High-Intensity Focused Ultrasound (HIFU) using PZT
and Piezocomposite Materials,” ISTU 4 Conference, Oct. 2004,
Kyoto, Japan, 3 pgs.
R. Seip, et al., “High-Intensity Focused Ultrasound (HIFU) Multiple
Lesion Imaging: Comparison of Detection Algorithms for Real-Time
Treatment Control,” IEEE Ultrasonics Symposium Proceedings,
Munich, Germany, 2002, pp. 1395-1398.
R. Seip, et al., “Real-time Detection of Multiple Lesions during High
Intensity Focused Ultrasound (HIFU) Treatments,” International
Symposium on Therapeutic Ultrasound, 2002, 8 pgs.
N.T. Sanghvi, et al., “Decision Theory Applied to High-Intensity
Focused Ultrasound (HIFU) Treatment Evaluation,” 2003 AIUM
Annual Meeting, Jun. 1-4, 2003, Montreal, Quebec, Canada, 24 pgs.
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Vascular Bundle (NVB) in Automated HIFU Treatment Planning
Using a Pulsed-Wave Doppler Ultrasound System,” 2004 ISTU Con
ference, Kyoto, Japan, 3 pgs.
R. Seip, et al., “Transurethral High Intensity Focused Ultrasound:
Catheter Based Prototypes and Experimental Results,” IEEE Ultra
sonics Symposium Proceedings, Puerto Rico, 2000, 4 pgs.
J. Tavakkoli, et al., “A Laparoscopic HIFU Probe for KidneyAblation
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Focused Ultrasound (HIFU)”, Translated and updated from TheJour
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on Therapeutic Ultrasound, Jun. 2003, Lyon, France, 6 pgs.
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based on 3D Modeling of the Prostate, Urethra, and Rectal Wall”,
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based on 3D Modeling of the Prostate, Urethra, and Rectal Wall”,
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US 8,235,902 B2
Page 4
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* cited by examiner
US. Patent
Aug. 7, 2012
Sheet 1 0f 16
US 8,235,902 B2
m:
Mimimzéxmz1
N
mmo?m2% fm
E,
5293m1.‘?;
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US. Patent
Aug. 7, 2012
Sheet 2 0f 16
US 8,235,902 B2
US. Patent
Aug. 7, 2012
Sheet 3 0f 16
US 8,235,902 B2
300
ACQUIRE BEFORE
IMAGE
E
l
DETERMINE ROI IN
BEFORE IMAGE
&
l
ACQUIRE AFTER
IMAGE
E
l
DETERMINE ROI IN
AFTER IMAGE
m
l
DETERMINE
PARAMETER
REPRESENTATIVE OF
LEVEL OF TISSUE
CHANGE BETWEEN
BEFORE IMAGE AND
AFTER IMAGE
m
l
PROVIDE VISUAL
INDICATION OF
LEVEL OF TISSUE
CHANGE ON DISPLAY
3 12
Fig. 3
US. Patent
Aug. 7, 2012
Sheet 4 0f 16
US 8,235,902 B2
402
Acquire Z-D RF reference image
‘
Automatic
TGC adjustm?m
Signal to noise and satm‘ation
percentage OK?
Yes
I Acquire pre-HIFU 2-D RF image W
l
I
w
Acquire post-IIIFU 2-D RF image
412 414
l/l/
4'
416
Calculate mean ab solute value of
N
the 2-D RF signal from the site
4,) 0
TCM cycle
Compute the energy of the spectrum from /|/
pre- and post-HIFU 2-D data
Convert the energy increase in color and
overlay on 2-D and embed into 3-D volume
424
image
Therapy done?
\
Generate Treatment /l/
Report
Fig. 4
Save post-HIFU Z-D RF image
as pre-HIFU 2-D RF image
US. Patent
Aug. 7, 2012
Sheet 5 0f 16
US 8,235,902 B2
2-D Sagittal image planes
Y
Transducer
114
Fig. 5
US. Patent
Aug. 7, 2012
Sheet 6 0f 16
US 8,235,902 B2
2-D Sagittal image planes —>
Pre-Focal
1’
Zone
A-lines: xk[n]
x1x2 x3...x14 X15X16X17
x30
.xk
Group for
Group for
Group for
1St lesion
2nd lesion
N"d leslo"
Fig. 6
US. Patent
Aug. 7, 2012
Sheet 7 0f 16
US 8,235,902 B2
HIFU OFF
HIFU OFF
HIFU OFF
HIFU OFF
Acquire
Acquire
Acquire
Acquire
2-D RF image
at T0
2-D RF image
at T1
2-D RF image
at T2
2-D RF image
at T3
1
HIFU ON
1
1Si Expose
HIFU ON
1
2nd Expose
1
HIFU ON
1
3rd Expose
1
Compute TCM using
HIFU ON
4Lh Expose
Compute TCM using
pre-HIFU data at T0
pre-HIFU data at T1
Compute TCM using
pre-HIFU data at T2
and
and
and
post-HIFU data at TI
post-HIFU data at T2
post-HIFU data at T3
Fig. 7
HIFU OFF
HIFU OFF
HIFU OFF
HIFU OFF
Acquire
Acquire
Acquire
Acquire
2-D RF image
at T0
2-D RF image
at T1
2-D RF image
at T2
2-D RF image
at T3
1
HIFU ON
1
15‘ Expose
HIFU ON
1
2nd Expose
1
Compute TCM using
HIFU ON
1
3rd Expose
1
Compute TCM using
HIFU ON
4"1 Expose
T
Compute TCM using
pre-HIFU data at T0
pre-HIFU data at T0
pre-HIFU data at T1
and
and
and
post-HIFU data at T1
post-HIFU data at T,
post-HIFU data at T3
Fig. 8
US. Patent
Aug. 7, 2012
Sheet 8 0f 16
US 8,235,902 B2
270
Power Spectrum
‘
l/l/
Bandwidth of the
image processing electronics
4
b
4
I I
fH2
272
4
fL3
I
fH3
151
2nd
3rd
frequency
frequency
frequency
band
band
band
274
276
Fig. 9
>
Frequency
US. Patent
Aug. 7, 2012
Sheet 9 0f 16
US 8,235,902 B2
Compute spectrum W 440
from the pre and
post-HIFU 2-D RF
data
Compute
DE1 (energy change in 131 frequency band)
W 4'42
DE2 (energy change in 2nd frequency band)
DES (energy change in 3rd frequency band)
i
Determine the maximum increase W
within these bands
Fig. 10
444
US. Patent
Aug. 7, 2012
US 8,235,902 B2
Sheet 10 0f 16
Acquire pre-HIFU 2-D signal
with imaging transducer
7
Apply HIFU to a desire
location
7
Acquire post-HIF U 2-D signal with
imaging transducer
System auto-adjust
or user manual
adjust TAP or HIFU
7
on time
Compute TCM reading at the location
508
TCM reading is high
enough?
Convert the energy increase in color and
overlay on 2-D and embed into 3-D volume
image
7
Go to next site for
treatment and TCM
Fig. 11
W512
US. Patent
Aug. 7, 2012
Sheet 11 0f 16
US 8,235,902 B2
TCM result from previous
treatment site adjacent to the
530
W
current site
TCM reading is high
enough?
538
System auto-adjust {V
or user manual
adjust TAP or H||:U
_
Apply the Same Settmg
TAP/HIFU on time to current W 534
on time
site
Start treatment and
Fig. 12
US. Patent
Aug. 7, 2012
Sheet 12 0f 16
US 8,235,902 B2
l
550
System provides the location
of thc currcnt sitc to TCM
library
7
552
Compare the location to all
sites been treated including
focal and pre-focal regions in
TCM library
554
This sitc has bccn
treated and TCM
reading is high?
556
System auto-skip
or user manual
Start HTFU treatment and
skip treatment at
this site
TCM procedure
Go to next
treatment site
Fig. 13
558
US. Patent
u.
Aug. 7, 2012
Sheet 13 0f 16
US 8,235,902 B2
US. Patent
Aug. 7, 2012
Sheet 14 0f 16
US 8,235,902 B2
com
mQ
25“ml5$8,%
NQ m M
2mm
&
US. Patent
Aug. 7, 2012
Sheet 15 0f 16
570
572
574
568
\
§
§
\
\
US 8,235,902 B2
US. Patent
Aug. 7, 2012
Sheet 16 0f 16
Fig 17
US 8,235,902 B2
125
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