INFORMATION TO USERS This manuscript has been reproduced from the microfilm master. UMI films the text directly fi-om the original or copy submitted.
6 TABLE OF CONTENTS (continued) 2.4.3 SOFTWARE STRUCTURE 38 2.4.4 PROGRAM LOOP 39 2.4.5 MAIN PROGRAM 40 2.4.6 ERROR TRAP 43 2.4.7 HARDWARE FOR COMPUTE
96 accepting new points until the second condition is again satisfied. When the end point of the trace reaches within 10 mm of the start of the trace,
97 previously entered traces, probe locations, and tumor center so that new ones can be entered. If the HP temperature computer has not run past this
98 gantry display center. If the gantry display center is not currentiy located at the center entered on the trace entry, the display would be spatial
99 The default screen temperature is shown here as 42.5° C and will always reflect the current setting. A.3.12 T/C VALIDATION; hot key = "V"
100 A.3.13 ENTER EDGE POINT: hot key = "P" This selection must be used after the traces are entered with the graphics tablet and before the
APPENDIX B: ORIGINAL PAIN ALGORITHM 101 The following algorithm describes the set of events for multiple pain button presses in the same approximate l
102 NO cc 2 posnx)N Btttthtmd PRESS? NO • fl , a 9 YSS posmoN POMT •X by 10% fl fl ^ posmoN PRESS? by 10% YES HO tc B , R —•-© posmoN to •» YES 100« s
STEP TWO: During each subsequent pass through the window the power will increase by 10%. This is to see if the patient can tolerate more power (the go
104 STEP FOUR: Additional presses inside the window will cause the power to be reduced by 10% from its previous value and be maintained at that value.
105 Step five is limited to three repetitions per window. After WINDOW 1 three, a button press inside a window with zero power will cause the window d
7 TABLE OF CONTENTS (continued) 4.1 TEMPERATURE CONTROLLER 82 4.2 PAIN BUTTON 83 CHAPTER 5.0: FUTURE WORK 85 APPENDIX A.O: PROGRAM USERS MANUAL 87 A.
APPENDIX C: WIRING CONNECTIONS VECTRA QS/20 2801 50 PIN IDC GANTRY POTENIOMETERS 25 PIN DB FEMALE SIGNAL NAME 1 a/d input chO 1 25 GND 3 a/d input chl
VECTRA QS/20 APPLE A/D CARD 2801 50 PIN WIRE NUMBER SIGNAL NAME IDC 35 bit 0/6 3 ch2 yellow center indicator 36 bit 0/7 1 chO black inner/outer indica
108 -L ... —^ orrr: —^ ± ... — X-' iC; ;'c ail > At9'BTO" 1^ "8 *«wao« 1^ d>-. 5f rt>^ t>Cc 6^ w^ ^ ^ ^ I i c« I
109 APPENDIX D.O: GRAPHICS TABLET AND BOX CALIBRATION D.l ACCURACY OF THE TABLET It was necessary to determine the accuracy with which data could be e
110 The true length of the lines was 21.2 mm. Since no trend can be seen in Table 1, it was concluded that no edge effects or nonlinearalities existed
Ill After this adjustment, it is necessary to correlate the digital values to be sent to the Data Translation Card that are required to produce each d
112 REFERENCES Anhalt D., "Two Methods for Relieving Patient Pain During Scanned Focused Ultrasound Hyperthermia," Unpublished p^per. Univer
113 EHederich C., Hynynen K., "Induction of hyperthermia using an intracavitary multi-element ultrasonic applicator," IEEE Tran Biomedical E
114 Hynynen K., "Methods of External Hyperthermic Heating," Clinical Thermclogy. Subseries Thermotherapv. Vol. 81, pp. 61-115, 1990. Hynynen
115 Marmor J.B., Pounds D., Postic T.B., and Hahn G.M., "Treatment of Superficial Human Neoplasms by Local Hyperthermia induced by Ultrasound,&qu
8 TABLE OF CONTENTS (continued) A.3.12 T/C VALIDATION 99 A.3.13 ENTER EDGE POINT 100 APPENDDC B; ORIGINAL PAIN ALGORITHM 101 APPENDUC C: WIRING CONNEC
116 Shimm D.S., Hynynen K., Anhalt D., Roemer R.B., and Cassady J.R., "Scanned focussed ultrasound hyperthermia: Initial clinical results,"
9 LIST OF ILLUSTRATIONS Figure 1. SFUS System 24 Figure 2. Original System Block Diagram 26 Figure 3. Treatment Display Screen 28 Figure 4. Controller
10 Figure 20. Press in Existing Window - Part 2 58 Figure 21. Pain Button Algorithm - Part 1 60 Figure 22. Pain Button Algorithm - Part 2 61 Figure 23
11 LIST OF TABLES Table 1. System/Program Checks for Scan Parameter Identification 65 Table 2. Display Checks from Dog Trials 66 Table 3. Thermocouple
12 ABSTRACT An interactive temperature and patient pain feedback controller with manual power control as a function of scan position has been develope
13 CHAPTER 1.0: INTRODUCTION 1.1 HYPERTHERMIA AND SCANNED FOCUSED ULTRASOUND Modem use of hyperthermia in the treatment of cancer began in the late 18
14 Overgaard 1989, hyperthermia was found to be most effective when combined with radiotherapy. In the opinion of the author, the optimal technique is
15 SFUS hyperthermia treatment can be made by looking at what percentage of the temperature probes in the target volume are above a therapeutic target
16 verbal description of the pain's location. This can be inaccurate due to the patient's difficulty in locational pain judgment. In respons
17 ultrasound for hyperthermia is patient pain. Out of the 31 patients that entered that study, 40% experienced pain with half of those experiencing &
18 important factors in pain sensation, and when does pain become excessive? In order to answer these questions it is necessary to look at the mechani
19 skin sensation because it has provided a survival advantage to the species in the past (Moran 1950) by alerting the animal before the source of th
20 expensive cup, the hand will still jerk away but not drop the cup. This demonstrates that after the brain perceives pain it must process the pain i
21 of the sensation of pain on the skin temperature can be seen by looking at equation 1 which was found by Buettner and used by Hardy after exposing
22 threshold to a painful stimulus (Hardy et al. 1967). The pain threshold will also be lower in areas where the tissue has been previously damaged. R
23 "1. The pain threshold-raising effect; 2. The pain reducing effect; 3. Reducing of pain by suppression of visceral and somatic effects themsel
CHAPTER 2.0: SYSTEM DESCRIPTION 24 2.1 EXISTING SYSTEM BEFORE MODIFICATION The system used to implement this study began as a conunercial diagnostic u
25 point (Figure 1). The gantry possesses five degrees of freedom (X, Y. Z. rotate, and tilt) but only two dimensional concentric X-Y octagonal scans
Order Number 1347581 A patient/therapist interactive feedback control system to regulate temperature and control paia in scanned focused ultrasound hy
T1 •irt* ! ft N> CfQ (A TO B CO R pr D • • PRE-EXISTING SYSTEM OPERATOR CONTROL OF OVERALL POWER FUNCTION GENERATOR H POWER AMPUFIERS APPLE COMPUTE
27 2.2 LIMITATIONS IN THE EXISTING SYSTEM The SFUS system at the University of Arizona did not originally have any practical means of controlling the
MENU DIRECTION OF ADJUSTABILITY SCAN OF CENTER SCREEN AREA 100% Quit Window diameter 20 mm Controller targota Zoom ControUer ia off Redraw ccroon Rese
29 Figure 3 shows the display screen during a typical treatment. The actual screen has the benefit of color to distinguish the different elements of t
30 thermocouples arranged in a line as shown in Figure 3. The color of each temperature displayed will be blue if the temperature is below the screen
31 does not become excessive in comparison to the size of the scan. A first order low pass filter has been installed on the signal lines to help alle
32 inner scan, the menu pointer will then advance to the perimeter of the inner scan around it, and then back to the menu list. When on the perimeter,
33 2.4.2 TEMPERATURE FEEDBACK SYSTEM. This section will describe how the uniformity of the temperature field in the tumor is improved while relieving
34 controller developed and analyzed by Lin et al. 1990, Lin 1990. A block diagram of this controller can be seen in Figure 4. TARQET BWOR /-* .> I
35 Ti, and Ti, are the proportional gain, integral or reset time, and derivative time, respectively. The PID section of the controller is written in d
the current and previous measured temperatures. The weighting factors for each of the temperatures in the temperature history were experimentally dete
37 One drawback of using a SISO controller analogous to Lin's is that it required preselected thermocouples to be used as input tor each sector
38 and Wittenmark 1984 or Middleton and Goodwin 1990), the sum of the error term in equation 3 was initialized according to equation 5 which was deriv
39 2.4.4 PROGRAM LOOP The program written to implement this work is structured with three levels of code. These levels of code can be categorized into
40 attention until input is received. By using the INKEY$ command, which checks the keyboard and then continues, it became possible to write keyboard
41 SEND CXJT SAFETY SIGNAL NO I 3AN1 I AQUIRE NEW GANTRY POSITION HAVE SCAN PARAMETBtS CHANGED I YES yes ! HAS PAIN BUTTON BSN PRESSED AUaORITHM I NO
42 extremely slow, taking up to one microsecond per check, which would effectively cut the program data sample rate in half. The other method would se
43 2.4.6 ERROR TRAP Since a program crash would have adverse effects on both the effectiveness and more importantly, the patient's safety, an err
44 that there may have been a pain program error. If this is the case, a counter is incremented and program execution is resumed in the hope that the
OPERATOR CONTROL OF OVERALL POWER FUNCTION GENERATOR n DUTY CYCLE CONTROLLER PATIENT PAIN BUTTON FIBER OPTIC CABLE POWER AMPUFIERS APPLE COMPUTER TO S
A Patient / Therapist Interactive Feedback Control System to Regulate Temperature and Control Pain in Scanned Focused Ultrasound Hyperthermia by Scott
46 The duty cycle controller box has six independent channels each capable of imposing a duty cycle of between 0% and 100%. At the current stage of de
47 The duty cycle signal is then the first signal that is fed into the AND gate (Figure 10). The second signal is the input signal to the box which mu
48 and effectively shutting off power to the transducers. Appendix C shows a complete schematic for the duty cycle box. 2.5 INTERACTIVE PAIN BUTTON DE
49 2.5.1 PAIN BUTTON ALGORITHM The goal of ±e following algorithm is to alleviate the pain while administering as much power to the patient as possibl
50 All displayed window powers (and all powers discussed below) are a percentage of the maximum absolute power of the sector that they are in. For exa
51 CASE 1: Presses in the first window. SITUATION 1.1; Single Window. STEP 1.1.1) When the pain button is pressed in an area where no previous windows
52 automatically increasing the percentage of window power in the controlled window by 10% with each pass through the window up to a maximum value of
53 h^jpens, a second window with 0% power is established behind the first whose power is controlled by button presses in the first window. This is sho
54 SITUATION 1.3: Triple Windows. STEP 1.3.1) If the patient delay time was longer that the time required for the Scan gantry to move two window diame
55 STEP 1.3.3) Assuming the patient delay time is known and that the pain covered an area larger than one window diameter (as indicated by a press in
2 STATEMENT BY AUTHOR This thesis has been submitted in partial fulfillment of requirements for an advanced degree at The University of Arizona and is
same as step 1.2.1. It is then possible for the gantry location to be inside of more than one window (i.e. the area where windows are overlapping in F
57 overlapping in Figure 17). When this happens, the gantry is again considered to be in whichever window has a lower power setting. CASE 2: Presses i
58 Scan Path OLD Press Location New y Window Old Window 3 New press Location Old } \ Old Window 2 Window 1 Figure 20. Press in Existing Window - Part
59 CASE 3: Press in window 3. STEP 3.1) If a press occurs in a "window 3" of Figure 15 or 18, it is handled in the same manner as shown in F
START PRESS? YES ESTABUSHWOCOWl INCAQUEPCW^ll 1 BY10ftUPT090% aiNl£S3HBI3| AFTER EACH PASS THROUGH 1 LCMBtPOV^MI SYIMAMOHCXD COKTINUE NO PfiESSINI? po
EXmiNQ WINDOW DEHir4D27 I YES ESTABUSH WINDOW 3 POWER CONTROLLED BY PRESSES INI PRSXtSTlNQ WINDOW cm 1 I 6* A ' A, *** A '®* / I no ESTAHUSH
62 LU ii Figure 23. Pain Button Algorithm - Part 3.
63 2.5.2 PAIN BUTTON OPERATION When the pain button is pressed (signified by a BEEP from the computer), a circle will be drawn on the screen behind t
64 50% power. The power percentages are in 10% increments which translates to 36 angular degrees on the circle per 10% change in power. 2.5.3 PAIN BUT
65 CHAPTER 3.0: EXPERIMENTS / RESULTS 3.1 PROGRAM VERIFICATION The correct identification of gantry scan parameters is critical to the proper operatio
3 DEDICATION This thesis is dedicated to bureaucracy and all the people who made this task almost impossible.
66 The displayed position of the gantry location is correct relative to all other scan information Inner sectors 8-12 are only displayed if an inner s
67 Table 4 lists the checks required to ensure that the ultrasound power is adjusted as specified by the program. Sector lines act as power boundaries
68 features outlined below and explained in the users manual located in Appendix A. Finally, they provided invaluable experience in the operation of t
69 sectors. Any thermocouples that the operator does not which to be used for control are deactivated at this time as per Appendix A 3.12. The control
CONTROLLER ON CONTROLLER ON 49.0 48.0 47.0 o U 46.0 IT 3 £ 44.0 Q. m 43.0 h 42.0 45.0 , IV ./ /.\ I \ i V • 41.0 40.0 40 50 //' /vl 'I If &a
71 The PID controller has been used on one patient for two consecutive treatments with results given below. More clinical results will be obtained lat
72 The next treatment to the same site of the same patient in Figure 25 is depicted in Figure 26 with the addition of the error initialization to the
73 The unifonnity of the temperature field can be measured by the variance of all of the temperature probes in the tumor. Figure 27 shows that the var
74 The two histograms in Figure 28 show the percentage of probes above a given temperature. The histograms were constructed from averages of all of th
75 Figure 29 displays the maximum ARMA filtered temperature input to the controller for each sector that contained thermocouples. The numbering and an
4 ACKNOWLEDGMENT I would like to thank everyone who made this work possible. First, Dr. Robert Roemer for his initial encouragement and then his conti
76 3.5 PAIN BUTTON For verification of the pain button system and accompanying software a series of tests were performed on both the old algorithm des
77 The start of a new scan resets all windows Pain button software debouncing only accepts valid presses Button press establishes a window behind the
78 administered to the patient prior to treatment. From the operators standpoint, the button was given to the patient if they were experiencing sharp
79 RECORDED BUTTON PRESSES (61%) Moved Wkxlcwr New Windows LoworedPcww EndolAlooinhin IncwMed Radka 860 PRESSES Figure 30. Breakdown of Recorded Butto
a logic flaw in reasoning. The flaw was that the old algorithm did not account for delay times longer that the time required for the gantry to travel
81 described, and the operators own experience, the new algorithm presented above was designed and awaits clinical trials.
82 CHAPTER 4.0: DISCUSSION 4.1 TEMPERATURE CONTROLLER The temperatures achieved with the addition of power control as a function of position could sti
83 Figure 28 shows that the temperature controller did what was expected- control the power in such a way as to increase the uniformity of the tempera
84 stopping the power from increasing and lowering the power in existing ones. This shows that the button is useful during treatments. Figure 31 shows
85 CHAPTER 5.0: FUTURE WORK There are many possible extensions to this work. This could include improvement of the controller by further eliminating i
5 TABLE OF CONTENTS LIST OF ILLUSTRATIONS 9 LIST OF TABLES 11 ABSTRACT 12 CHAPTER 1.0; INTRODUCTION 13 1.1 HYPERTHERML\ AND SCANNED FOCUSED ULTRASOUND
86 The program could also be made more intuitive by an improved user interface other than the keyboard. This new user interface could include a mouse,
87 APPENDIX A.O: PROGRAM USERS MANUAL A.l APPLE COMPUTER PROGRAMS The pain program communicates with two other computer programs. The first is the sca
A.2 HP TEMPERATURE COMPUTER PROGRAMS 88 The second computer that the pain program commimicates with is the HP temperature computer. The program to run
89 THE PAIN PROGRAM WILL THEN PROMPT FOR THE PATIENT'S NAME. If ENTER is pressed without entering a name, the default name of TEST will be used.
90 backup disk and then checks to make sure that the name is unique. If it is not the program requires that a different disk be used without files of
A.3.4 ZOOM: hot key = "Z". Used to change the scale of the gantry position display. The " +" and are used to add or subtract 10 mm
92 available as will be seen from the power percentages for each sector changing to a target temperature. Once on, every time the HP temperature compu
93 A.3.6 REDRAW SCREEN: hot key = "R". Used redraw the gantry position portion of the screen in the event of any "garbage collection&qu
94 A.3.9 ALIGN TUMOR TRACE: hot key = "A". This selection is used to align the tumor trace and probe locations to the current gantry locatio
95 In the rare event that the pointer on the screen is stuck in a comer, regardless of the movement of the stylus, the graphics tablet did not initial
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