Вы находитесь на странице: 1из 76

Philips Research

TIPS User Manual for V1.2

Therapy and Imaging Probe System


(TIPS)

User Manual
For TIPS V1.2 Application Software

Philips Research North America


345 Scarborough Road
Briarcliff Manor, NY 10510-2099
Tel. (914) 945-6000
Fax: (914) 945-6375
Email:tips@philips.com
www.research.philips.com/TIPS

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 1 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Revision History

Version Description Initials Date


1.0 Initial Document RS 4/30/2008
1.1 Added 2 cautions p.9 RS 5/19/2008
1.2 Added water drape and coupling gel information to Section 2.2 RS 10/15/2008
1.3 Corrected Grab Loop known bug; added Appendix F; replaced 63 mm with 64 mm for RS 12/03/2008
transducer face to coupling membrane distance; added stand-alone degasser information

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 2 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Table of Contents
1. General Information 5
1.1 Introduction 5
1.2 General Safety Statements 7
1.3 Software Usage Statement 9
1.4 TIPS Specifications 10
1.5 TIPS Overview and Main Components Description 11
1.6 TIPS Console 13
1.7 TIPS Annular Array Assembly and Motion Stage 16
1.8 TIPS Accessories 18
2. Operational Instructions 20
2.1 Getting Started 20
2.2 Preparing the Acoustic coupler 22
2.3 Defining Waveforms 28
2.4 Defining Treatments 33
2.5 Advanced Features 43
2.6 Typical Protocols 49
2.6.1 Simple Example 49
2.6.2 Ultrasound Mediated Drug Delivery Example 50
2.6.3 HIFU Heating Example 52
2.6.4 Locating and Centering on a Thermocouple 56
2.6.5 Acquiring 3D Ultrasound Imaging Data 58

Appendix A: TIPS Functional Block Diagram 60


Appendix B: Preferences and Default Settings 61
Appendix C: Degassed Water Procedure 67
Appendix D: Imaging Transducer Alignment Procedure 69
Appendix E: 3D Image Display 70
Appendix F: Defining Custom Motion Paths 74
Appendix G: Known Bugs 76

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 3 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 4 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1. General Information
1.1 Introduction

Therapy and Imaging Probe System (TIPS)

Philips Research brings pre-clinical therapeutic ultrasound solutions to the small animal research
community. This therapeutic ultrasound device, working with your ultrasound imaging
equipment, provides a unique and powerful tool to apply genetic intervention or deliver drugs
locally and noninvasively. The unit delivers ultrasound which can induce a variety of bio-effects:
gene transfection, drug release, alteration of capillary endothelia, thrombolysis and thermal
heating (via high-intensity focused ultrasound, or HIFU). Integrated planning and real-time
monitoring enable localized intervention to a specific organ and tissue.

TIPS was designed for several reasons. The first reason was to allow for explicit user control of
the acoustic parameters of an ultrasonic therapeutic system to ensure repeatable, robust, and
consistent performance in drug delivery, gene delivery, and ultrasound thermal and ablation
experiments. The second reason was to allow for loose coupling between the therapy system
and a diagnostic imaging system in order to optimize therapeutic guidance and monitoring.
Therefore, such systems for pre-clinical experimental use would have advantage of providing a
consistent interface and toolset to the research community.

This document is intended to provide the basic information to understand the capabilities of the
TIPS, and how to operate and maintain it. It is mandatory to have hands-on training for the
safe operation, use and maintenance of this device.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 5 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 6 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.2 General Safety Statements

The TIPS was designed to be used as a pre-clinical research tool only. It should only be used by
qualified personnel. To safely and correctly use TIPS and to maintain its performance, the
operator must fully understand its operation, its function, and maintenance.

TIPS is an electro-mechanical device, which under certain circumstances could present an


electrical shock hazard to the operator and/or animal model. It is mandatory to read and
understand this users manual and to fully comply with the safety instructions contained in this
document to assure maximum safety during operation.

TIPS contains no user-serviceable parts. Any repair (if needed), must be performed by
authorized service personnel. Unauthorized changes or modifications to any part of TIPS could
have hazardous consequences. Changes or modifications to the system hardware or software
must not be made unless specifically authorized by the manufacturer and installed by
authorized service personnel.

This manual contains precautionary notices, the definitions of which are described below:

Notice Definition
Indicates any condition or action which, if not strictly observed, could
DANGER result in direct danger such as serious personal injury or possible death
or serious property damage such as total loss of equipment or fire.
Indicates any condition or action which, if not strictly observed, could
CAUTION result in possible danger such as partial equipment damage or data
loss.

CAUTION

TIPS is not for use in Humans. Use in animal models should comply with all applicable laws
and standards.

DANGER

This device is not explosion proof. Do not use it in the presence of items such as explosive
gases, flammable liquids, flammable anesthetic mixtures with air, oxygen, or nitrous oxide.

CAUTION

Do not block the front or rear vents of the TIPS console. Adequate airflow is required to
prevent the computer and amplifier electronics from overheating.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 7 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

TIPS Console

High voltages are present within the TIPS console, the TIPS transducer, and motion control
electronics, which are capable of inflicting serious injury or death from electric shock. Under no
circumstances should persons other than trained service personnel remove equipment covers,
undertake the installation, maintenance, or repairs of the system.

Power can be interrupted by overloads that blow fuses or trip circuit breakers, or by loss of
power at the service outlet. Should a loss of power occur, turn the TIPS power switch off, the
isolation transformer power switch off, and disconnect the main isolation transformer power
cord until power is restored. If a fuse is blown repeatedly or a circuit breaker trips after being
reset, it may indicate an equipment malfunction. Do not attempt to operate the system until the
unit has been inspected by a qualified service technician.

Many circuits are monitored by ground fault alarms, which are intended to warn of current leaks
that may damage sensitive medical equipment or allow hazardous conditions. Should a ground
fault alarm into which TIPS is connected activate, immediately terminate its use by turning the
TIPS power switch off and the isolation transformer power switch off, and disconnect the main
isolation transformer power cord until the alarm activation had been identified and corrected.

Food or liquids should not be placed on the system or in its immediate vicinity. Fluids that
inadvertently come in contact with electrical components may cause damage to the system or
present electrical safety hazards.

TIPS Annular Array Transducer

The TIPS annular array transducer generates high intensity focused ultrasound (HIFU) to elicit a
therapeutic effect. HIFU can damage and kill cells and tissue.

DANGER

Do not place hands or other body parts in front of the annular array while the therapeutic
signal is activated.

The TIPS must be operated with the annular array/HIFU transducer immersed in degassed
water, with all of the air bubbles potentially present on the transducer face removed prior to
use. Activating the transducer in a non-aqueous environment will cause delamination of the
transducer face and may permanently damage the transducer.

CAUTION

Activating the therapy or activating the annular array when it is not surrounded with
degassed water will damage it.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 8 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The annular array should be visually inspected prior to use in order to prevent the use of a
transducer which contains cracks or other defects. If any defects are observed, the array should
not be used.

DANGER

The annular array connectors are not watertight and must not be immersed in water or any
other liquid. Failure to comply might result in damage to the array or serious injury or death.

The array/cable junction is not waterproof, and must not be immersed in water or any other
liquid. Failure to comply might result in damage to the array or serious injury or death.

The annular array is constructed of delicate components, which may be damaged if dropped,
and should be considered unsafe under these circumstances. If connected to TIPS, the array
should be disconnected immediately. Any annular array that has been dropped should be
returned to Philips Research for inspection and repair.

Do not handle the annular array by its cables. When not in use, clean and dry the annular array
assembly, and either leave it in securely attached to the acoustic coupler, or store in its
protective case.

CAUTION

Do not leave the annular array front face in water for extended periods of time. Remove the
annular array from the acoustic coupler as soon as the experiment is completed, clean it, dry
it, and store in its protective case.

CAUTION

Do not use alcohol to clean the acoustic coupler, as the acrylic may break while the alcohol
evaporates due to stresses in the acrylic.

1.3 Software Usage Statement

By purchasing or choosing to operate TIPS, the user understands and will abide by the terms
described in the License Agreement Operating Software, included with the sales quote for the
TIPS purchase.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 9 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.4 TIPS Specifications

Transducer
Geometry: Annular array with concentric imaging space
Number of elements: 8
Active outer diameter: 80 mm
Active inner diameter: 33.5 mm
Natural focal length: 80 mm, spherical
Center frequency: 1.3 MHz (nominal)
-6 dB BW: 1.0 to 1.7 MHz
Acoustic pressures at
Maximum rated excitation: >9 MPa and -6.5 MPa in water
Recommended axial steering: Up to 15 mm from natural focus.
Focus -6dB size (elevation x lateral x axial): 1 mm x 1 mm x 6 mm
Acoustic power (instantaneous, typical): 3 W / element (unmatched), 6 W / element (matched)
Acoustic intensity (SPTA, minimum): 1000 W / cm2 (unmatched)

Drive electronics
Multiple, programmable multi-segment waveforms
Waveform length/channel: Maximum 512K, minimum 8
Resolution: 12 bits
D/A conversion rate (max): 150 MHz
Output frequency (max): 75 MHz
Voltage setting: 0 to 60Vpp, specified in software
Power (electric) per channel: Up to 12.5 W for CW excitation
Internal Trigger PRF: 1 MHz (max)
External Trigger input: 5V DC negative going edge, 1 MHz (max)

Motion Control
Features: 2-axes (X-Y) software controlled, 3rd axis (Z) manual
Protections: Spill resistant, Limit switches (adjustable)
Travel distance (minimum): 80 mm (X-Y); 40 mm (Z)
Max motor speed: 10 mm /sec (load dependent)

System
Video input: S-video, composite video
Video capture: 30 frames / sec; NTSC or PAL
Thermocouples: T type, two for external use
AC Power: 110/220V 50/60Hz AC operation (user-selectable)
500W (max)

Scanner/Scanhead Compatibility for real-time imaging concentrically


Philips Medical Systems
HDI5000: P7-4
Sonos 7500: S12
iU22: X7-2, 3D9-4v
iE33: X7-2, S12-4

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 10 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.5 TIPS Overview and Main Components Description

TIPS consists of a high-power therapeutic ultrasound annular array transducer, a state-of-art


programmable acoustic signal source located within the TIPS console, a versatile ultrasound
coupling device, a programmable precision motion assembly, associated interconnection cables,
and an accessory package. An optional high-frequency commercial imaging probe and system
(not included) can be coupled to TIPS for accurate visualization, therapy planning, and therapy
monitoring purposes. A diagram of the system is shown in Figure 1.5.1, and an overview on
how an imaging system can be coupled to TIPS is shown in Figure 1.5.2. More details are
provided with a functional block diagram in Appendix A.

The therapy transducer is a custom-designed annular array with eight elements, each with
the same surface area. The transducer has a specified electrical-to-acoustic efficiency of more
than 60% between 1.0 and 1.6 MHz. The center region of the transducer has an opening that is
capable of accepting ultrasound imaging probes confocally aligned with the therapy transducer.

Eight high-power amplifier circuits capable of supplying up to 12.5 Watts per channel are
attached to the eight independent elements of the therapy array. An arbitrary waveform
generator (AWG) drives each element under computer control. The arbitrary wave generator
can be configured to send sequences of independent waveforms in a user configurable manner.
Triggering of the therapy array can be accomplished internally, or externally, e.g., through an
ECG signal. This flexibility in the trigger circuitry allows for the appropriate interleaving of
imaging sequence with a therapeutic sequence of ultrasonic exposures.

The acoustic coupler was specifically designed to couple the therapeutic ultrasound energy to
small animal models (mice, rats, rabbits, etc.) It houses the annular array in a degassed
waterbath, and is supported by the motion stage of TIPS. Under computer control, the motion
stage automatically and mechanically positions the coupler and array so as to execute a pre-
defined treatment sequence. It also provides flexibility for array and target alignment under
joystick control.

The center piece of the system is its control program. The control program allows for the
independent configuration of each element / arbitrary wave channel through the in-program
signal design or importation of externally defined waveforms. The duty cycle and amplitude can
be actively controlled. The spatial location of the focus of the therapeutic probe can be adjusted
either manually or automatically by defining a region of interest through a graphical interface.
Powerful scripting language support further allows for the execution of specific treatment
sequences during the execution of the treatment plan. Integration with the clinical imaging
system is performed by screen capture of the output of the scanning system.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 11 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 1.5.1. TIPS overview and main components

Imaging
Therapy Probe
Annular Ultrasound
Array Imaging
System

TIPS

Imaging
Array Inter-
Annular Acoustic connection
Array Inter- Coupler with
connection Array

Video Signal

Figure 1.5.2. Optional ultrasound imaging system attached to TIPS

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 12 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.6 TIPS Console

Refer to Figures 1.6.1 and 1.6.2 below for the location and description of the various interfaces
to the TIPS console.

Figure 1.6.1. TIPS Console Front Panel Figure 1.6.2. TIPS Console Rear Panel

Front Panel

Enable switch: toggle this switch ON/OFF to enable the power amplifier assembly that
delivers energy to the HIFU array. This button has to be in the ON (illuminated) position to
deliver therapeutic ultrasound energy.

PC button: press to turn the TIPS PC ON.

XY Joystick ports: connect the supplied joystick to these ports to control the TIPS XY motor
stage using the joystick.

Lockable door: unlock to allow access to the front panel of the PC within the TIPS console;
use the key supplied with the TIPS to lock this door.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 13 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Rear Panel

Power plug: connect the TIPS system to one open outlet of the supplied isolation transformer
using the supplied power cable.

CAUTION

Do not connect a TIPS system configured for operation at 110V to 220V; likewise, do not
connect a TIPS system configured for operation at 220V to 110V, as damage will occur.

Power switch: toggle this switch ON/OFF to control the power to all console components.
Note: switching this switch to the ON position turns the console fans and motor control
electronics on, but does not turn the computer or amplifier on. Use the PC button and enable
switch to turn these devices on.

Video In connector: connect the ultrasound imaging system video output signal to this
connector with the supplied cable (use either the S-video or RCA cable, as required by your
ultrasound imaging system).

Audio Out connector: TIPS computer audio output.

T-type Female Thermocouple connectors: connect external T-type thermocouples to these


inputs to record experiment temperature information or to control treatment execution based
on temperature information. Use Ports 1 and 2 for this purpose. Ports 3 through 5 are allow for
additional (optional) temperature inputs. Connect the annular array transducer thermocouple
cable to the thermocouple connector labeled XDCR.

CAUTION

Failure to connect the transducer thermocouple disables the transducer safety overheat
protection circuitry which may lead to transducer damage.

SMA connectors (8): power amplifier output to the therapy array. Connect the annular array
to these connectors, matching the numbers on the rear panel to those engraved on the SMA
connectors of the array. Channel 1 connects to the inner-most annulus of the array; channel 8
connects to the outer-most annulus of the array.

Ethernet connector: TIPS computer network connection.

USB connectors (4): connect the computer keyboard and mouse to two os these connectors.
The remaining USB connectors can be used to connect other USB devices to the TIPS
computer.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 14 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

DVI connectors (2): connect the computer display to one of these connectors. Up to 2
computer displays can be connected to the TIPS.

Motor connector pairs (2): motor stage control connectors. Connect the motor power and
limit switch cable pairs for each motor axis (X and Y) to these connectors.

BNC Trigger IN: connect an external trigger to enable the waveform generation (TTL-level,
positive to negative edge). If an external trigger is not used to trigger the start of the waveform
generation, Trigger IN must be connected to Trigger OUT.

BNC Trigger OUT: TIPS internal trigger for enabling waveform generation. If an external
trigger is not used to trigger the start of the waveform generation, Trigger OUT must be
connected to Trigger IN.

BNC Marker OUT: Indicates the start of the next waveform segment programmed into the
arbitrary waveform generator.

BNC Analog IN: -5V to +5V input signal connection. Allows the recording and monitoring of
an analog signal source.

BNC Analog OUT: reserved for future use.

BNC Aux: reserved for future use.

Assembly

Place the TIPS console on a benchtop or on the floor at the intended place of usage. Place the
isolation transformer close to the TIPS console, and setup the keyboard, display, mouse, and
joystick. Verify that all power switches are in the OFF position.

Connect the TIPS console power cable to the isolation transformer. Connect the display power
cable to the isolation transformer. Connect the isolation transformer power cord to a power
outlet. Note: do not use an extension cable to connect the isolation transformer to a power
outlet.

Connect the display video cable from one of the TIPS DVI connectors to the display.

Connect the keyboard to one of the USB connectors, and connect the mouse to another USB
connector. Alternatively, connect the mouse to one of the USB connectors located on the back
of the keyboard.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 15 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.7 TIPS Annular Array Assembly and Motion Stage

Motion Stage

The motion stage holds the transducer assembly in place, aids in transducer/target alignment,
and translates the transducer assembly during the execution of the treatment plan. It consists
of 2 motorized positioning stages (XY), 1 manual positioning stage (Z), a base plate, power and
limit switch interconnection cables, and a joystick.

Motion Stage Assembly

Mount the vertical axis (Z) motion stage on top of the motorized two axis stages, and fasten it
with two -20 screws. Connect the two axis stages to the motion controller via the supplied 6-
and 4-pin cables and motor connectors. All connectors are clearly labeled for identification.
Finally, connect the joystick to the XY joystick ports.

Annular Array Therapy Transducer

The annular array transducer assembly (Figure 1.7.1) is composed of the following items: (a)
an optional imaging probe and (b) its mounting/alignment collar, (c) the annular array therapy
transducer and (d) its mounting/positioning assembly, and (e) an acoustic coupler (filled with
degassed water during operation) with an acoustic window on it bottom.

The mounting/positioning assembly (Figure 1.7.2) for the annular array comprises: (1) a plastic
mounting piece, (2) and (4) stabilizing rods, (3) vertical adjustment, (4) ring cover, and (5)
interconnection cable bundle (containing 8 individual element leads and one thermocouple
lead).

Annular Array Assembly

Place the plastic collar (b) over the sector probe (a) and fasten it with three set screws (if you
are installing an ultrasound imaging array and coupling it to TIPS).

Mount the annular array (c) on its mounting/positioning assembly (d) and fasten it with the set
screws on the rim of the plastic mounting piece (1). Verify that the set screws are not too tight
and do not protrude from the plastic mounting piece.

Place the sector probe collar inside the center hole of the therapy transducer mounting piece,
as shown in Figure 1.7.3 (if installing an ultrasound imaging array).

Place the assembly into the acoustic coupler and rotate to desired location and tighten wing
nuts to secure the ring cover on the top of the acoustic coupler, as shown in Figure 1.7.3.

Attach the translation stage extension arm to the coupling bolus and loosen the last ball joint to
allow for rotation of the extension rod; then screw the rod into the vertical stage, as shown in
Figure 1.7.4.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 16 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 1.7.1. Annular Array Assembly Components

Figure 1.7.2. Array Mounting/Positioning Assembly

Adjust the annular transducer height within the acoustic coupler by turning the vertical
adjustment screw. For accurate focal zone and treatment region alignment, and to ensure a
horizontal array alignment, the plastic mounting piece should always be mounted tightly against
the horizontal step on the acoustic coupler. Spacer rings are provided if other vertical
adjustment heights are desired (see section 1.8, TIPS Accessories).

Figure 1.7.3. Installed Imaging Array Figure 1.7.4. Completed Scanning Assembly and Array

Connect the transducer cables to the SMA connectors on the back of the TIPS console. Finally,
connect the transducer thermocouple plug to the thermocouple connector labeled XDCR.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 17 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

1.8 TIPS Accessories

The accessories included with the TIPS are shown in Figure 1.8.1.

Figure 1.8.1. TIPS Accessories

The TIPS accessories include the following items:

#118 O-ring: use this O-ring to attach the acoustically transparent membrane to the acoustic
coupler tip.

#119 O-ring: use this O-ring to provide additional support to attach the acoustically
transparent membrane to the acoustic coupler tip.

5 mm spacer ring: position this ring inside the acoustic coupler between the horizontal step
within the acoustic coupler and the bottom edge of the annular array mounting piece to ensure
a horizontal annular array position within the acoustic coupler.

10 mm spacer ring: position this ring inside the acoustic coupler between the horizontal step
within the acoustic coupler and the bottom edge of the annular array mounting piece to ensure
a horizontal annular array position within the acoustic coupler.

Ruler: use the ruler to measure transducer-target distances to determine if spacer rings are
required to obtain the optimum position, and to determine optimum depth focusing information
for focal zone placement.

Angled mirror: use to verify the presence/absence of air bubbles trapped on the face of the
annular array or at any other place inside the acoustic coupler.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 18 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Brush: use to remove any air bubbles attached to the face of the annular array. All air bubbles
located on the face of the annular array or within the acoustic coupler must be brushed
off/removed prior to activating the therapeutic ultrasound.

CAUTION

Activating the therapy or activating the annular array when air bubbles are present on its face
will damage it. Remove all air bubbles from the annular array face.

Alignment Phantom: use to verify that the focal zone of the annular array is confocally
aligned within the imaging field of the optional ultrasound imaging transducer.

5/64 Allen Key: use to tighten the setscrews for mounting the annular array within the array
holder, tighten the setscrews to hold the ultrasound imaging transducer within its collar, and to
tighten the screws that attach the collar into the annular array holder.

3/16 Allen Key: use to assemble the motor stage.

Bare-Wire Thermocouple: therapeutic ultrasound-compatible thermocouple which can be


used to measure temperature information during TIPS experiments.

Thermocouple Extension cable: connect between the TIPS and the thermocouple, as
required.

Syringe and Tubing: use to gently fill the acoustic coupler with degassed water, making sure
so as to not create any bubbles in the process.

Chemets Test Kit: use to measure the level of dissolved oxygen in the water, to determine if
the water is sufficiently degassed for TIPS use.

CAUTION

Use only degassed water in the acoustic coupler. Water must be degassed to a level 3 ppm
of dissolved O2 as indicated by the chemets test kip.

Additional items required for TIPS operation not included with the TIPS are:

- Degassed Water ( 3 ppm dissolved O2, refer to Appendix C for additional information)
- Ultrasound Gel
- Target/Animal Model Holding Fixture

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 19 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2. Operational Instructions
2.1. Getting Started

Turn the isolation transformer on, turn the monitor on, and turn the console power switch on.
Now, turn the PC button on, and wait for Windows to boot and to display the desktop shown in
Figure 2.1.1.

Figure 2.1.1. TIPS Desktop screen

Double-Click on the TIPS program icon to launch the application software. After launching, the
display should show a window similar to that shown in Figure 2.1.2.

Figure 2.1.2. TIPS Application Program Window

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 20 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Verify that the power enable switch is in the off position, all 8 array channels and array
thermocouple connected to the console, and that the joystick is connected to the console.

If the TIPS is connected to a compatible ultrasound imaging device, power up this device. The
ultrasound image display should appear in the video display box, as shown in Figure 2.1.3.

Figure 2.1.3. Application screen with active Video Display

Prior to starting with the experiments, it is a good idea to define a study and its name at this
time, and add notes, as required, by filling in the information under the Notes window, as
shown in Figure 2.1.3. All datafiles, treatment protocols, treatments, images, temperature
traces, movie files, and all other data related to the experiment will be recorded under a tree
structure identified by the information from the Notes window. This data can then be reviewed
at any other point in time from within the TIPS application program under the Review window,
or from the TIPS computer desktop by double-clicking on the Study Summary icon.

Figure 2.1.3. Notes Window Example, Review Window Example, Study Summary Icon

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 21 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2.2 Preparing the Acoustic Coupler

Attach the acoustic coupler to the motion stage, and remove the annular array assembly.

Spacer Selection

The focal zone of the annular array should always be positioned within the target zone of the
treatment to ensure the highest sonication intensities. The center of the focal zone of the
annular array used with the TIPS is located 80 mm from its surface (geometric focus),
centered below the array. For highest system efficiencies, electronic focusing away from the
geometric focus should be kept as small as possible, and not exceed +/- 15 mm. Spacers are
provided to facilitate placing the array and thus its focal zone within the target region, while
minimizing focal zone displacement from the geometric focus of the array, all while keeping the
array parallel to the acoustic coupler and firmly aligned with it. Firm alignment of the array and
acoustic coupler is important, as otherwise the array may shift position within the acoustic
coupler during experiment execution, inadvertently moving the focal zone and potentially
exposing non-targeted tissue to ultrasound.

When spacers are not used, and the vertical adjustment knob is used to position the annular
array/plastic mounting piece at the bottom of the acoustic coupler, the distance between the
array surface and the tip of the acoustic coupler is 64 mm. This implies that the geometric focus
of the array is located 16 mm below the tip of the acoustic coupler, as shown in Figure 2.2.1

Annular Array
Acoustic coupler

Array/Plastic
Array Mounting Piece mounting piece
positioned flat
against the acoustic
coupler
80 mm 64 mm

Location of Geometric Focal Zone


(without electronic steering)

Figure 2.2.1. Geometric Focal Zone Location without Spacer Ring

In this position, TIPS can be used to reach tissue targets as deep as 19 mm, and 34 mm with
electronic steering. If it is desired to sonicate tissue at different depths, the appropriate spacer
ring(s): 5 mm, 10 mm, or both should be used to allow for the annular array to be parallel to
the acoustic coupler and firmly aligned with it, together with the appropriate depth steering.
Figure 2.2.2 shows an example where both spacer rings are used to firmly position and align
the annular array within the acoustic coupler.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 22 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Array/Plastic mounting
piece positioned flat against
the spacer rings
5 and 10 mm spacer rings
installed (red)
80 mm 79 mm

Figure 2.2.2. Focal Zone Location with both 5 and 10 mm Spacer Rings installed

In this position, TIPS can be used to reach target tissue located at the surface of the animal
model, and electronic (depth) focusing should be used to fine-tune the focal spot location and
depth, as required to cover the entire target volume for the particular animal model and
treatment plan being considered.

Select the appropriate spacer ring for the experiment and animal model before filling the
acoustic coupler and starting with the experiment, and install within the acoustic coupler.

Water Filling

Fill the acoustic coupler approximately half-way with degassed water using the syringe ( 3
ppm dissolved O2 content). Verify the content of dissolved O2 of the degassed water prior to
filling the acoustic coupler. Follow the instructions for the Chemets test kit for this procedure.
Avoid introducing unnecessary bubbles into the water during the filling procedure. This will
increase the amount of dissolved O2 in the water. Refer to Appendix C for a procedure to make
degassed water, if required.

CAUTION

Use only degassed water in the acoustic coupler. Water must be degassed to a level 3 ppm
of dissolved O2 as indicated by the chemets test kip.

CAUTION

Levels of degassed water above 3 ppm dissolved O2 increase the chances of cavitation.
Cavitation leads to air-bubbles that may collect on the surface of the annular array, which
may damage the array due to delamination.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 23 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Inspect the annular array for signs of wear and tear, cracks, etc. Do not use the array if it has
been dropped, or shows cracks on its surface. Pre-wet the front surface of the annular array
with degassed water, and then gently mount the array and holder within the acoustic coupler,
tighten the 3 mounting screws, and turn the vertical adjustment screw so that the array and
holder are firmly positioned against the spacer rings (if any), or the ledge within the acoustic
coupler.

Check the acoustic coupler for leakage around the coupling window. Replace the acoustically
transparent membrane or O-rings, as necessary.

The following materials can be used as acoustic coupler membranes:


- 48 gauge Mylar film,
- ceran wrap, or
- non-lubricated latex condom,
all stretched tightly and without wrinkles to cover the bottom acoustic coupler opening, held in
place by 1 or 2 O-rings.

Use the mirror to verify that there are no air bubbles present on the annular array front face, or
in the interior of the acoustic coupler. Use the brush to remove all air bubbles located on the
array or acoustic coupler prior to proceeding.

CAUTION

Remove all air bubbles from the annular array face and inside of the acoustic coupler.

Once all of the air bubbles from inside the acoustic coupler have been removed, insert the
ultrasound imaging transducer, if applicable. If an ultrasound imaging transducer is not being
used, leave the center hole of the annular array open to aid in visual alignment of the coupler
to the target.

Target Preparation

CAUTION

Using TIPS with animal models should comply with all applicable laws and standards.

Consider the following suggestions a general guide on how to use the TIPS with targets and/or
animal models.

The target (be it either a phantom, in-vitro tissue sample, tissue culture, animal model, or other
target) must be kept stationary or immobile with respect to the TIPS acoustic coupler. This
can be accomplished with phantoms, in-vitro tissue samples and tissue cultures by placing the
sample in a stationary holder, appropriate for the sample being considered. If sonicating animal
models with TIPS, this is typically accomplished by applying anesthesia appropriate for the

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 24 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

animal model and experiment duration being considered, and placing the animal model within
an appropriate holding fixture.

Always place an acoustic absorber or a large water volume behind the target or animal
model, to prevent ultrasonic energy reflections or standing waves from interfering with the
planned sonication. Absorbing material such as Sorbothane (McMaster Part number 8514K55, or
equivalent) can be used for this purpose. Use ultrasonic gel to completely couple the target or
animal model to the absorber, and avoid and remove any air bubbles located between the
target and the absorber.

To increase ultrasound energy transfer from the TIPS acoustic coupler to the animal model, it
may be necessary to remove hair follicles from the tissue surface. This can be accomplished
either by shaving the surface of the targeted region with a razor and/or using depilatory cream.
It is important that air bubbles are not present between the acoustic coupler tip and the surface
of the target region.

Before positioning the acoustic coupler on the target region, center the motion stage in XY. This
allows for additional freedom during fine alignment and procedure execution. Also, prior to
positioning the acoustic coupler tip on the target, thoroughly cover the target region and the tip
of the coupler with ultrasonic gel, making sure as to not introduce any air bubbles in the gel
during application.

Depending on the size of the animal model or target and the experimental setup, it may be
necessary to raise the target so that the tip of the acoustic coupler can come in contact with the
target region. Large movement and positioning flexibility via the ball joints and manual Z stage
positioning adjustment exist for this purpose. An example rat model setup with TIPS is shown in
Figure 2.2.3.

TIPS XYZ Motion


Positioning Stage
Annular Array
Acoustic
Coupler

Acoustic Rat Model


Absorber
Heating Pad

Figure 2.2.3. Example of TIPS setup with rat model

Finally, it is best to position the target region flat or parallel to the tip surface of the acoustic
coupler. This allows the motion stage to smoothly translate the acoustic coupler window (and
with it the annular array and focal zone) across the tissue surface, allowing to sonicate larger
regions without having to re-align the acoustic coupler needlessly.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 25 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

In some cases, it may be advantageous to also remove the smallest of trapped air bubbles
within the ultrasonic gel used to couple the TIPS acoustic coupler to the animal. This may be
accomplished by centrifuging the ultrasonic gel within a syringe inside a centrifuge. Removing
trapped air bubbles within the gel increases acoustic coupling efficiency between the acoustic
coupler and the tissue of interest. Centrifuge settings of 3000 rpm for 10 minutes easily remove
the trapped air bubbles from the coupling gel, as shown in Figure 2.2.4 below. Be careful not to
introduce air bubbles back into the gel during gel application.

Figure 2.2.4. Coupling gel before (left) and after (right) centrifuging

Alternative setup and target coupling strategies can also be employed with TIPS. One such
alternative is shown in Figure 2.2.5, where a water drape is used to couple the acoustic energy
from the coupler to the target. This setup uses a very thin layer of coupling gel between the
water drape and the target, allows for conformal coupling to targets that are not flat, and
minimizes frictional displacements between the coupler and the target, as the TIPS coupler
never actually touches the target, but moves within the water volume located within the water
drape. A very thin, flexible membrane (i.e. cellophane) is recommended for the water drape,
and an additional holder is required to position the drape between the TIPS coupler and the
target. Use degassed water to fill the water drape.

Annular Array
Acoustic
Coupler Water drape
and holder
In-vitro
Acoustic tissue target
Absorber

Figure 2.2.5. TIPS setup example using a water drape

Target Alignment

Regardless of whether or not ultrasound imaging guidance is going to be used with TIPS, it is
necessary to first align the target visually with the acoustic coupler tip.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 26 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

For this purpose, center the tip of the acoustic coupler on the target region (i.e. a tumor).
Verify that the target region is visible through the transparent coupling membrane, when
viewed through the center hole of the annular array, and verify that the target is centered
within the window (Temporarily remove the ultrasound imaging probe and collar for this
purpose, if required). Use the joystick and fast/slow motion speed, and the manual Z
adjustment, as required for this purpose.

Verify that in this position, good acoustic coupling exists between the acoustic coupler tip and
target, and that no air bubbles are present between the membrane and target region. Remove
the air bubbles or add gel, as required.

Avoid placing the acoustic coupler tip in direct contact with the target region. Instead, leave
approximately a 1-2 mm gap between the target region and the tip of the acoustic coupler,
filled with acoustic gel. This gap allows for easy and smooth target/coupler translation, while
providing an acoustic path for the ultrasonic energy to travel from the annular array to the
target, as shown in Figure 2.2.6.

Tip of acoustic coupler


Small gap between Ultrasound Gel
membrane and target Target

Figure 2.2.6. Height positioning of the acoustic coupler

Once the visual alignment has been completed, re-insert the ultrasound imaging transducer, if
available, and verify that the target is visible in the ultrasound image as well. Use the XYZ
motion stage for fine position adjustments, with feedback from the imaging transducer, as
required. Also, utilize the ultrasound imaging feedback to determine the desired treatment
depth.

Finally, reset the origin of the motion stage, so that it is centered on the tumor, as shown in
Figure 2.2.7. All motion will now take place referenced to this X=Y=0 mm location.

Action:
Origin
Reset

Result:
Origin
Reset

Figure 2.2.7. Reset origin of Motion Control Stage, centered on target region

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 27 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2.3 Defining Waveforms

CAUTION

Do not operate the annular array outside its frequency calibration range of 1 MHz to 1.7 MHz.

CAUTION

Do not operate the annular array outside its electronic focusing range of 65 mm to 95 mm.

CAUTION

Do not operate the annular array outside its pressure calibration of 0 MPa to 7 MPa (peak
negative pressure).

CAUTION

Do not operate the annular array outside its power calibration range of 0 W to 40 W.

CAUTION

The acoustic pressure calibration [in MPa] is valid over the frequency range of 1.0 to 1.7
MHz. The acoustic power calibration [in W] is valid only at one pre-defined frequency, defined
in the power calibration file.

It is necessary to define the sonication waveform prior to commencing the experiment. The
exposure parameters of the defined waveform will then be applied at each treatment plan point
during the execution of the treatment.

TIPS allows defining waveforms in 3 different ways: (i) by defining the duty cycle and repetition
frequency of the waveform, (ii) by defining waveforms containing multiple pulses, and (iii) by
allowing the user to download the actual shape of the waveform itself. All of these waveforms
are defined from the Waveform pull-down menu located on the top left of the TIPS application
program.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 28 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Waveform Duty Cycle

Define a sonication waveform using the duty cycle option by specifying the frequency,
amplitude, duty cycle, focus location, and pulse repetition frequency (PRF) in the Set waveform
duty cycle window, as shown in Figure 2.3.1.

Figure 2.3.1. Defining Waveforms via Duty Cycle

The amplitude of the waveform can be specified either in [MPa] or in [W], as required. While
the acoustic pressure calibration [in MPa] is valid over the frequency range of 1.0 to 1.7 MHz,
the acoustic power calibration [in W] is valid only at one pre-defined frequency, defined in the
power calibration file.

The pulse repetition frequency sets the frequency of the internal TIPS waveform trigger (see
Figure 2.3.2). Sonication only occurs when the TIPS is triggered. This is accomplished either
with the TIPS internal trigger (BNC Trigger OUT connected to BNC Trigger IN), whose repetition
frequency is specified in the PRF field, or via an external trigger (supplied to BNC Trigger IN).
Note: In case an external trigger is used to activate sonication, the PRF value does not have
any effects on the sonication, and should be left at its default value of 10 Hz.

To define a continuous wave (CW), specify the duty cycle as 100%. Note: If the duty cycle is
100%, the PRF value does not have any effects on the sonication, and should be left at its
default value of 10 Hz.

Trigger (either internal or external)

Duty Cycle (%)

Amplitude [MPa or W]

1 Period (100%)

Figure 2.3.2. Waveform Duty Cycle Parameters

Press Set to define the waveform and store it in memory. Note: sonication does not start until
Run is pressed in the waveform window.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 29 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Set Multiple Waveforms

Use this option if multiple and different waveforms are required during the sonication, by
specifying the frequency, number of cycles, waveform amplitude, number of pulses, the pulse
repetition frequency, and the focus location, as shown in Figure 2.3.3.

Figure 2.3.3. Defining Waveforms via Set Multiple Waveforms

The main difference between the set multiple waveforms and waveform duty cycle waveform
definition is that the set multiple waveform window allows the user to specify the length of the
pulse in number of cycles, rather than in % duty cycle.

Multiple waveforms (consisting of more than 3 pulses) can be defined selecting the Append to
existing waveform checkbox, up to the memory limit of the TIPS waveform generation
hardware. Press Set to define the waveforms to store them in memory. Note: sonication does
not start until Run is pressed in the waveform window.

If more than 1 pulse or waveform is defined, TIPS will output the first waveform or pulse
(Pulse 0) when a trigger signal is received (either internal or external), the second waveform
or pulse (Pulse 1) when the next trigger signal is received (either internal or external), the
third waveform or pulse (Pulse 2) when the next trigger signal is received (either internal or
external), etc.

Internally, waveforms are stored as Pulse Segments. Each pulse segment can consist of a
pulse delayed, pulse looped, and pulse residual sub-segment. This implementation allows
defining long pulses and implements depth focusing by using very little waveform memory.
These pulse segments can be displayed and reviewed on the waveform display, as shown in
Figure 2.3.4.

Figure 2.3.4. Selecting and Displaying Waveform Segments (2 Waveform example shown)

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 30 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

If it is desired to output many waveforms with a single triggering event, it is necessary to


program TIPS by removing the triggering wait constraint for subsequent waveforms. This is
accomplished by right-clicking on the Waveform window title which brings up the advanced
waveform control window, as show in Figure 2.3.5.

Figure 2.3.5. Advanced Waveform control Window

In this window, select the desired pulse segment that should not wait for a trigger event, and
select no wait for this segment. Note: it is advisable that the first pulse (Pulse 0) always waits
for a trigger.

Waveform Loading

If the sonication requires a specific waveform shape that is not covered by the previous two
options, the user can always download a specific waveform into TIPS. Select Waveform ->
Load -> From File for this purpose. Waveforms are user-defined text files containing numbers
between -1 and 1, corresponding to the waveform shape sampled at 150 MHz.

Two built-in waveforms: chirp.txt and chirp1.txt are available as examples.

Waveform Display and Amplitude Control

Once the waveform is generated or loaded, it will be displayed on the Waveform panel (Figure
2.3.6). A complex waveform can be displayed in three sections: Pulse 0 Delayed, Pulse 0
Looped and Pulse 0 Residual, as according to the pull-down selection menu on the top right
side of the waveform display window. A simple waveform may be fully displayed with Pulse 0
Delayed alone. The above procedures only produce the same waveform for all 8 channels
(Arb1 to Arb8). The delayed portion of the waveform usually consists of a single cycle and a
time delay offset to allow for appropriate focusing. The second waveform entitled looped
makes up the bulk of the waveform time and is the same waveform repeated over and over.
Any remaining portion of the waveform is kept in the residual portion.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 31 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.3.6. Waveform Display

The ultrasound sonication can be manually activated by clicking the Run button and then the
green button turns into a red Abort button. The ultrasound is manually switched off by
clicking on the Abort button and the red Run button returns into the green Run button.

The amplitude of the waveforms can be adjusted as equivalent acoustic pressure amplitude in
[MPa], as shown in the Amplitude panel in Figure 2.3.7. Typing the value in the top box shifts
the maximum peak negative pressure. Adjustment of the slider allows user control over the
current amplitude of the selected waveform (i.e. the selected segment and channel).

In the Waveform Info panel of Figure 2.3.7, the Center frequency, Peak Negative Pressure (in
[MPa]), Peak Power (in [W]), Pulse Repetition Frequency, Duty Cycles, etc. are displayed. The
currently visible waveform is number N of M. Each waveform can be logically grouped together
as a series. For example, a tone burst may consist of a delayed portion, a looped portion, and a
residual portion. These are summarized in the bottom portion of the Waveform Info Panel.

Always verify the information displayed in the Waveform information panel prior to activating
the ultrasound, as extensive waveform editing and adjustments may sometimes generate
unexpected waveform results and amplitudes.

Figure 2.3.7. Amplitude Control and Waveform Information Summary

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 32 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

By right-clicking on the Amplitude window title, an advanced amplitude setting window is


displayed (Figure 2.3.8.). This window allows the user to arbitrarily enable or disable (via
checkbox) each of the 8 channels of the annular array, or individually define the amplitude for
each annular array channel (via individual slider controls).

Figure 2.3.8. Advanced Amplitude Setting Window

2.4 Defining Treatments

The final step prior to being able to deliver ultrasound energy to the target is to define the
treatment plan. The previous step of defining the waveforms did not allow for the definition of
the overall sonication on time, and neither did it allow for defining where spatially this energy
is to be deposited. These parameters must be defined prior to commencing with the treatment,
and are specified via the Motion Controller interface window (Figure 2.4.1).

Defining a treatment consists of 2 steps: (i) defining a treatment region consisting of many
individual treatment sites, and (ii) defining the action to take at each of those treatment
sites.

Figure 2.4.1. Motion Controller Main Interface Window

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 33 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Typically, a treatment region covers the extent of the region to be treated (i.e. a tumor), plus
some margin, that depends on the animal model, tumor model, or experiment setup. Defining
treatment regions is important, as TIPS is unable to treat a large treatment zone without
mechanically positioning the annular array focal zone at many different locations due to the
overall TIPS focal zone size. Larger treatment zones are thus treated by sonifying one treatment
site, moving to a different treatment site via the XY motion stage, sonifying that site, moving to
the next treatment site, sonifying that site, etc., until the entire desired treatment region has
been sonified.

Defining Treatment Regions

The simplest method of defining a treatment region is to define a rectangular grid, over which
the motion stage will translate the transducer during the execution of the treatment. This is
accomplished within the Motion Controller window Scan tab. Select a treatment region Start,
Stop, and Increment value for motion in the X direction, and a region Start, Stop, and
Increment value for motion in the Y direction. Figure 2.4.2 shows an example treatment zone
that is 9 mm wide by 9 mm tall, with 1 mm motion steps.

Figure 2.4.2. 9x9 mm Treatment Region

It is also possible to define regions of other shapes, including rectangles, ellipses, lines, and
regions of arbitrary shape (freehand). Such regions are defined from within the Motion
Controller Window -> Mode: Create Regions -> Rectangle tab, as shown in Figure 2.4.3.

Figure 2.4.3. Create Regions

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 34 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Selecting Ellipse from this drop down menu, for example, allows one to define an elliptical
treatment region. The additional buttons: New, Delete, and Rename allow the user to edit
existing or to create new regions, as required.

Selecting different modes from the Mode: menu (Figure 2.4.4), allows additional treatment
region editing, including moving regions (used to translate the entire treatment region to a
different location), moving control points (useful for editing arbitrary shaped treatment regions),
and moving the motion controller itself.

Figure 2.4.4. Region Editing Mode

To move the motion stage and transducer to a particular point within the treatment region,
select from the Motion Controller Window -> Mode: Move MotionController, and then click on
the desired region within the treatment region. TIPS will move the array to the selected
coordinates. This is useful when centering the annular array at the point of highest measured
temperature, for example.

While it is likely that the simple rectangular regions easily accessible from within the Motion
Controller window will suffice for most TIPS applications, the user needs to be aware that it is
also possible to define the described other treatment regions.

Each treatment region is assigned a unique numeric label by the TIPS software, as shown in
Figure 2.4.5. This unique label allows the user to track individual treatment regions across
different experiments.

Unique
Region
Label

Figure 2.4.5. Unique Region Numbering

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 35 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

It is recommended to always define treatment regions referenced from the center of the
desired treatment zone (i.e. a tumor). This allows for easy initial alignment (i.e. the TIPS array
can be centered on the tumor), provides an easy to remember reference point for the origin
(reset origin to X=Y=0 mm), and allows for easy treatment zone definition where (-1) * the
Starting point in X = the Stopping point in X, and where (-1) * the Starting point in Y = the
Stopping point in Y. An example of a rectangular treatment region that follows these guidelines
(superimposed on a tumor) is shown in Figure 2.4.6.
Treatment
Y
Site

-2 Start X = -3
Stop X = +3
Rectangular
Inc X = 1
Treatment (0,0)
Region covering
X Start Y = -2
a Tumor
Stop Y = +2
+2 Inc Y = 1

-3 +3 [mm]

Figure 2.4.6. Rectangular Treatment Region to cover a tumor (top view)

Each gray spot in the Treatment Region of Figure 2.4.6 represents a treatment site, the location
to which the motion stage will move the annular array and thus the focus of the transducer to
deliver a pre-defined ultrasound dose. The amplitude and shape of the ultrasound signal that is
delivered at each location was defined as described in Section 2.3, Defining Waveforms. The
duration of each exposure is defined in the next section: Defining Actions for Treatment Sites.

A focal location increment size of 1 mm is recommended to achieve full region coverage, as the
focal zone size of the annular array is approximately 1 mm in diameter (see Section 1.4, TIPS
Specifications). Treatment location overlap is achieved by selecting increments smaller than 1
mm; leaving tissue not exposed to ultrasound energy between treatment locations is achieved
by selecting increments larger than 1 mm.

Defining Actions for Treatment Sites

A treatment region is a collection of many individual treatment sites. Once the ultrasound
exposure (or actions) have been defined for each treatment site in the treatment region, the
overall treatment plan is defined and ready to be executed.

The action that will occur at each treatment site is specified be clicking on the Motion Controller
Window -> Configure or the Motion controller Window -> Events button, as shown in Figure
2.4.7.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 36 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.4.7. Defining Actions for each Treatment Sites

By clicking on either Configure or Events, a script editing window will appear that
provides powerful tools to define or configure the action or event at each treatment site. An
example of this window is shown in Figure 2.4.8.

Script or actions that


will be executed at
Available each treatment site
scan
events

Figure 2.4.8. Event script editing Window

The left side of this window contains a list of available commands and actions (scan events)
from which the user can choose, to define the action or event that will be executed at each
treatment site.

The right side of this window contains the actual script (collection of scan events), which will be
executed at each treatment site.
The buttons Add>>, Remove, Remove All, Down, and Up are used to add and remove
events from the left window to the right window, and allow the user to change the ordering of
these events. Finally, the ----------- pull-down menu contains a list of pre-defined event scripts
for several typical TIPS uses, and also allows the user to save new events for future use.

The possible scan events available include:

Scan Event Description


Move Synchronously Executes move and waits for move to complete

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 37 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Move Asynchronously Executes move and does not wait move to complete
Wait Pauses for specified period of time
Start TriggerArb Starts the therapy transmission
Stop TriggerArb Stops the therapy transmission
Start Save Movie Starts movie capture
Stop Save Movie Stops movie capture
Write To Screen Writes a message to the standard output (including log
file)
Save Image Saves jpeg image to a file
Start Save Temperature Starts saving temperature into a data file
Stop Save Temperature stops saving the temperature into a data file
ImageOverview Captures an image at each location and then stacks
them as a movie for further review
Move To Origin Move back to the origin position
No Event An empty command
Change Amplitude Changes the amplitude of the awg by a scalar factor
Abort Scan Aborts the current scan
Change Pulse Repetition Frequency Changes the Pulse Repetition Frequency
Every Nth execution Allows the user to define events conditional on the
execution
Get Delta Temperature Obtains the temperature difference from a baseline
Get Region Math Computes the (min/avg/max) of the selected ROI,
returns a value
Get Temperature Returns the temperature of the defined thermocouple
Move to Origin Moves the motor system back to the origin
Save Image for 3D Reconstruction Saves Images in the format required for the 3D viewer
Trigger Once Force a single Trigger event

Also, the following additional programming commands are available for conditional control:

If First Move
If Nth Move
If Physio
If temperature
Else
Endif
If Value of Region
These programming commands allow for conditional logic to be placed within the scanning
protocol. For example, often there are certain events that should only be performed at the
beginning of the scan:

If First Move
(events at the beginning)
Else
(other events)
Endif

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 38 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The predefined TIPS event scripts include:

Predefined Event Scripts Description


3D Reconstruction Use this script to collect ultrasound imaging data for
later review with the 3D viewer program
Delta Temperature Use this script to measure the change in temperature
due to an ultrasound exposure. Useful for locating and
centering the TIPS applicator with respect to a
thermocouple
Monitor Temperature Use this script to maintain the temperature of a region
at a pre-defined value by modulating the ultrasound
exposure for that region
Overview Captures an image at each treatment site, and stacks
them into a movie for later viewing
Scout Arb Region of Video Monitors the change of a region during the ultrasound
exposure
Scout Arb Temperature Monitors the temperature of the location of the
thermocouple during the ultrasound exposure
Scout Region of Video Monitors the change of a region
Scout Temperature Monitors the temperature of a region

It is suggested to explore the capabilities of the TIPS for treatment planning by reviewing the
available script examples first, prior to developing more specific scripts.

Example: Scout Arb Temperature Event Script

Load in the Scout Arb Temperature event script by selecting it from the Treatment Events (or
scout events) pull-down menu, as shown in Figure 2.4.9.

Figure 2.4.9. The ScoutArbTemperature Event Script

Notice that the script consists of the following scan events: Move Synchronously, Start Trigger
Arb, Wait, Get Temperature, and Stop Trigger Arb. This script will be executed at each
treatment site.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 39 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The first event moves the positioning stage to the first location of the treatment region
specified by the user (see Section: Defining Treatment Regions). Once the positioning stage
has reached this location, the ultrasound exposure is initiated by the second command, with the
user-selected parameters (see Section: Defining Waveforms). The treatment site will be
sonified during the time specified with the Wait scan event, as shown in Figure 2.4.10.

Select the scan event


you want to modify by
clicking on it

Change the value of


the scan event, as
required, in the Event
Info field

Figure 2.4.10. Changing the value of the Wait scan event

This value can be changed by highlighting the scan event, and filling in the required fields in the
Event Info region. In this particular example, the treatment site will be sonified for 5000 ms,
by the sonication waveform previously defined.
The fourth event instructs the TIPS to collect the temperature of one of the thermocouples
connected to the console. The user is able to define which temperature value is recorded by
this Get Temperature scan event, as shown in Figure 2.4.11.

Select the scan event


you want to modify by
clicking on it

Change the value of


the scan event, as
required, in the Event
Info field

Figure 2.4.11. Changing the thermocouple input for the Get Temperature scan event

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 40 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

In this particular example, the system will record the temperature information of the
thermocouple that is plugged into the Extra 1 thermocouple input.

Finally, the fifth event turns off the sonication by disabling the arbitrary function generator. The
motion stage now moves the applicator to the next treatment site of the treatment region, and
the process is repeated.

Executing the Treatment

Once the appropriate action for each treatment site has been specified, the overall treatment
plan is completed and can be executed.

Turn the enable switch on the front of the console to its on position. The switch is on when
lighted green.

To execute the treatment plan defined with the Configure button in the Motion Controller,
press the Scout button. To execute the treatment plan defined with the Events button in the
Motion Controller, press the Complete Scan button, as shown in Figure 2.4.12.

TIPS allows the user to specify 2 different treatment scripts (under Configure and Events).
This is useful, for example, when it is desired to execute a treatment without ultrasound
exposure to verify the experimental setup, and then execute a treatment with ultrasound
exposure, once it is verified that the experimental setup is correct and working properly. In this
case, the user would define a script that does not include the ultrasound exposure with the
Configure button, and define the same script but with ultrasound exposure with the
Events button.

Figure 2.4.12. Executing the Treatment

The movement of the applicator can occur with several patterns. The scan is calculated ahead
of time and ordered into a series of moves. These moves in the case of a two dimensional grid
are along one axis, then a jog in the second axis, followed by the movement along the first
axis. Once the moves are calculated and held within a list, the order in which they are executed
depends of the desired scan type or method.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 41 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.4.13. Scan Method Options

As indicated in Figure 2.4.13, currently there are five options for the Scan Methods menu:
Ordered Grid, Raster Grid, WindShield, OutwardsIn, and Boundary:

Ordered Grid - The moves are executed in such a way that one dimension is scanned and the
second moved, then the first dimension is scanned from the beginning. (This is similar to a full-
carriage return typewriter).

Raster Grid - The moves are executed in such a way that one dimension is scanned, the second
moved, then the first dimension is scanned backwards.

WindShield - The moves are executed in such a way that the first move in the list (containing N
moves) is executed first, followed by the move half way through the list (N/2), then the second
move, then the move half way through the list +1 (N/2+1), and so on.

OutwardsIn - The moves are executed in such a way that the first move in the list (containing N
movies) is executed first, followed by the last move (N), followed by the second move ,
followed by the last move 1 (N-1), followed by the third move, etc.

Boundary The moves are executed only around the boundary of the pre-defined treatment
region, with a user-specified step size between treatment sites. Figure 2.4.5 (right panel) shows
an example of a boundary scan on an elliptical treatment region.

Simple scanning orders of the Ordered Grid, Raster Grid, WindShield and OutwardsIn are
illustrated in Figure 2.4.14.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 42 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.4.14. The scanning orders of Ordered Grid (A), Raster Grid (B), WindShield (C) and
OutwardsIn (D).

Turn the enable switch on the front of the console to its off position when the treatment is
complete. This avoids unwanted and accidental sonications.

2.5 Advanced Features

Video Display

The following information is only applicable to TIPS systems connected to a compatible


ultrasound imaging device.

There are advanced features associated with the Video Display. Right-click the Video Display
and select the Create view from the prompt menu, as shown in Figure 2.5.1.

Figure 2.5.1. Advanced Features for the Video Display

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 43 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

TIPS will this way generate a new window called Interactive Video, as shown in Figure 2.5.2.

Figure 2.5.2. Interactive video window

Within this window, TIPS allows image and video capture. The images will be saved as *.jpeg
files using the Grab Frame button located on the bottom of the window. The videos (at the
specified or available frame rate) will be stored as mpeg encoded files with the Grab Loop
button option.

Under the Tools menu, 3 options are available: Adjust focus, Set Depth, and Region.

Adjust focus allows for a focal zone marker (blue oval) to be positioned on top of the
ultrasound image to indicate the location of the focal zone of the ultrasound transducer. This
allows one to register the ultrasound image with the focal zone of the therapy transducer. The
(registered) focal zone depth is shown in the upper left corner of the interactive video window,
as shown in Figure 2.5.3.

Figure 2.5.3. Adjusting the focus overlay for image/focal zone registration

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 44 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Set Depth resets in the displayed image the alignment of the surface (the line at 0.0mm) and
the geometrical focus (the line at a depth of 80 mm) of the therapy transducer, as shown in
Figure 2.5.4. This allows the user to calibrate (using a graphical tool) the correspondence
between the video image size and real-world distances. This is usually accomplished by
dragging the vertical line to correspond to the transmit axis of the therapy transducer on the
image, then dragging the horizontal lines to landmarks with known distances away from the
transducer. By double clicking on either of the horizontal lines, a dialog window is opened that
allows for manual entry of the specific depths associated with each line.

Figure 2.5.4. Image size calibration using Set Depth

Region represents the region of interest (ROI), which enables the user to place the region of
ultrasound therapy over the appropriate structures. The program also allows some image
analysis through pixel analysis of the pixels within the ROI. There are five sub menus for the
pull down menu Tools -> Region: New for creating a new ROI, Type for changing the shape
of the ROI (basic shapes are available, such as circle, oval, or rectangle, and user-defined
freehand regions), List for listing current ROIs (such as Region 0, Region 1, and so on),
Delete for deleting a ROI, and Tools -> Region -> Graph for prompting a new window called
ROI Analysis.

There are four types of regions: Circle, Oval, Rectangle and Freehand. For example, the Circle
type can be set by selecting the submenu Circle.

As shown in Figure 2.5.5, a ROI can be created by the selecting the New option, and in this
way multiple ROIs can be created. Each ROI can be deleted by clicking the ROI and then
selecting Delete. The active ROI can also be moved through user control and deleted if the
delete key is pressed.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 45 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.5.5. Region definition in the interactive video window

Selecting Tools->Region->Graph prompts a new window called ROI Analysis, as shown in


Figure 2.5.6. On the new window, a plot of the average pixel values within the previously
defined ROI versus time is presented. From the pull-down menu at the upper right corner of
this window, there are 3 selections: Average, Maximal or Minimal. They correspond to average,
maximal or minimal pixel values within the ROI, respectively.

Figure 2.5.6. Region analysis from the ultrasound image

The graph is configurable to allow specific analyses including the average, maximum, minimum
values of pixels in the ROI. The scrollable graph displays time versus value and is freezable at
any point in time. Also, the pixel analyses can be saved to an xml text file accessible through
the Review panel. The label at the top is how the saved data is stored. Data is stored
continuously while the Save check box is selected.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 46 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Time Series

A real-time plot (time series) display of many parameters can be generated with TIPS. These
are useful for monitoring values (such as temperature, gray-scale ultrasound image values, or
external analog inputs) during the execution of the experiment, and can be saved for additional
analysis off-line.

Temperature Display

To generate a temperature scrolling display, right-click on Temperature Readings and select


Scroll Display, and then the parameter of interest. Possible temperature monitoring parameters
are: transducer temperature (measured with a thermocouple located inside the annular array
transducer), amplifier temperature (measured with a thermocouple located on top of the RF
power amplifier located inside the TIPS console), Extra 1 (connected to a user thermocouple
plugged into thermocouple input port 1 on the rear of the TIPS console), and Extra 2
(connected to a user thermocouple plugged into thermocouple input port 2 of the rear of the
TIPS console). A typical thermocouple display from a thermocouple embedded in tissue during
sonication is shown in Figure 2.5.7.

Figure 2.5.7. Temperature scroll display

Select Save on the scroll display to save the time series to a file. It will be saved in the
directory specified in the Notes section under Study and Name, date, and a subdirectory
called Timedata. Note: you need to de-select the Save checkbox to actually write the data to
disk.

Right-click on the scroll display to change axis values, and to activate zooming functions.

Change the temperature sampling period (if desired), by selecting Edit -> Preferences ->
Temperature Monitor -> Polling Period.

These displays are useful to monitor treatment temperature values.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 47 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Ultrasound Image Values

To generate an ultrasound image value scrolling display, right-click on Video Display -> Create
View. Define a region of interest (with an ellipse, rectangle, freehand, etc.) on the region to be
analyzed. Note that TIPS will assign a distinct region name to these regions, and highlight the
current region in red. It is possible to create many regions of interest (ROI) on the ultrasound
image, as shown in Figure 2.5.8.

Figure 2.5.8. Regions of interest defined on the ultrasound image

Next, on the interactive video window select Tools -> Region -> Graph, and the desired
computation to be done for the ROIs. Choice include: compute the average pixel value for the
pixels in the region, the minimum value for the pixels in the region, or the maximum value for
the pixels in the region. An example scroll display for 3 ROIs is shown in Figure 2.5.9.

Figure 2.5.9. Regions of interest scroll display

Select Save on the scroll display to save the time series to a file. It will be saved in the
directory specified in the Notes section under Study and Name, date, and a subdirectory
called Timedata. Note: you need to de-select the Save checkbox to actually write the data to
disk.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 48 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Right-click on the scroll display to change axis values, and to activate zooming functions.

These displays are useful to monitor changes in the ultrasound image due to the sonication, for
example, or changes in the ultrasound image due to the addition of contrast agents (i.e.
microbubbles) for drug- or gene delivery purposes.

External Analog Input Values

To generate an external analog input scrolling display, first connect the external signal to the
BNC Analog IN connector (-5 to +5V range). Then, click on Display -> Digitizer to display this
information.

Select Save on the scroll display to save the time series to a file. It will be saved in the
directory specified in the Notes section under Study and Name, date, and a subdirectory
called Timedata. Note: you need to de-select the Save checkbox to actually write the data to
disk.

Right-click on the scroll display to change axis values, and to activate zooming functions.

Change the analog input sampling period (if desired), by selecting Edit -> Preferences ->
Digitizer -> Polling Rate.

These displays are useful to monitor and record external signals important to the experiment,
such as EKG signals. It is also possible to use these signals to control the execution of the
experiment, by calling the If Physio scan event within a script.

2.6 Typical Protocols

The following section provides example protocols spanning many of the capabilities and typical
uses of TIPS.

2.6.1 Protocol 1: Simple Example with Default Scanning Events

Purpose:

Get familiar with TIPS and sonicate a small treatment region using the default parameters.

Procedure:

1. Define the default waveform with TIPS using Waveform -> Generate -> Specify Duty Cycle
and hit Set. The default waveform parameters are: PRF = 10 Hz, Focus = 80 mm,
Frequency = 1.4 MHz, Amplitude = 1 MPa, and Duty Cycle = 100%.

2. Use the default treatment plan with Xstart=Ystart= -2 mm, Xstop=Ysotp=2 mm, and
Xincrement=Yincrement=1.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 49 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

3. Select the default sonication script by selecting the script: ScoutArbTemperature either
under Motion Controller Configure or Motion Controller Events.

4. Verify that in the script, the sonication ON time for each treatment site is 5 seconds (select:
Wait -> Event Info -> 5000 ms), and click OK.

5. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

This script will deliver ultrasound energy with the selected sonication parameters for 5 seconds
at each of the defined 25 treatment sites. Remember to turn on the enable switch located on
the front of the TIPS console to enable the RF power amplifier used in driving the annular array
prior to executing the script, and remember to turn off the enable switch after sonication has
been completed.

2.6.2 Protocol 2: Ultrasound Mediated Drug Delivery Example

Purpose:

Use TIPS for drug or gene delivery experiments.

Procedure:

- Example 1 (distinct delivery dosage at each treatment site) -

1. Stable microcapsules with a drug capsulated inside a polymer shell are employed as drug
delivery vehicles. Such microcapsules are intravenously injected into and then circulate in
the bloodstream. Once microcapsules flow into the tumor, the microcapsules are destroyed
by the therapy ultrasound beam. In this way the encapsulated drug is released inside the
tumor.

2. Define a pulsed excitation waveform that will cause the microbubbles to rupture using
Waveform -> Generate -> Multipulse. Example: Number of Pulses =1, PRF (Hz) = 800,
Focus (mm) = 80, Frequency = 1.2 MHz, # of Cycles = 360, Amplitude (MPa) = 2, as
shown in Figure 2.6.2.1.

Figure 2.6.2.1. Defining a pulsed waveform for drug delivery

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 50 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

3. Use the joystick or Motion Controller -> By Hand -> Jog Control to move the annular array
focus to the center of the tumor under visual guidance or ultrasound image guidance.

4. Select Motion -> Reset origin, to establish this new position as the x=y=0 origin.

5. Select the script: ScoutArbTemperature either under Motion Controller Configure or


Motion Controller Events.

6. In the script, select a desired sonication ON time for each treatment site. Example: select:
Wait -> Event Info -> 5000 ms, to activate the sonication for 5 seconds at each treatment
site, and click OK.

7. In the script, ignore any Get Temperature settings, as a thermocouple is not used in this
example.

8. Define the desired treatment region that would cover the tissue target zone (i.e. a tumor,
for example): Xstart=Ystart=-2, Xstop=Ystop=2, Xincrement=Yincrement=2 mm.

9. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

- Example 2 (ultrasound delivery occurs continuosly) -

1. If it is desired to sonify the tumor continuously, a different process must be used. Complete
the steps of the procedure above to step 4. Then, program TIPS with the script shown in
Figure 2.6.2.2. This script turns on the sonication during the first move (i.e. during the first
treatment site), and does not turn it off until it has reached the last treatment site. In the
script, select a desired sonication ON time. Example: select: Wait -> Event Info -> 1000
ms, to activate the sonication for 1 seconds at each treatment site. Since a Xstart=Ystart=-
2, Xstop=Ystop=2, Xincrement=Yincrement=2 mm treatment size will be defined, the
sonication needs to be turned off after the last treatment site. For this particular example,
the last treatment site is site 9. Thus, in the script, select If Nth Move -> Event info ->
Movement Number = 9, and click Ok.

Figure 2.6.2.2. Continuous sonication

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 51 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2. Define the desired treatment region that would cover the tissue target zone (i.e. a tumor,
for example): Xstart=Ystart=-2, Xstop=Ystop=2, Xincrement=Yincrement=2 mm. Note: the
number of treatment sites in this treatment region MUST correspond to the value specified
in the If Nth Move event info, otherwise, it may be possible that the sonication stops
prematurely, or not at all. This must be avoided.

3. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

2.6.3 Protocol 3: HIFU Heating or Ablation Example

Purpose:

Use the TIPS to heat up or ablate a small region of tissue.

Procedure:

- Example 1 (heat at a single location) -

1. Enable the joystick and move the transducer assembly and focal area to the desired region
in the tissue.

2. Define a high-power excitation waveform that will cause a large temperature rise in the
target zone using Waveform -> Generate -> Specify Duty Cycle. Example: Frequency = 1.0
MHz, Duty Cycle = 100%, Acoustic Power = 25W.

3. Click Run in the Waveform window to start the sonication, then click Abort in the
Waveform window to stop the sonication.

- Example 2 (heating a region with temperature monitoring) -

4. Enable the joystick and center the transducer assembly and focal area to the desired region
in the tissue.

5. Place a bare-wire thermocouple within the target region using a cannula, then remove the
cannula to only leave the thermocouple within the target region. Use ultrasound imaging, if
necessary/possible to determine the location of the thermocouple tip within the target
region. Connect the thermocouple to Port 1.

6. Define a high-power excitation waveform that will cause a large temperature rise in the
target zone using Waveform -> Generate -> Specify Duty Cycle. Example: Frequency = 1.0
MHz, Duty Cycle = 100%, Acoustic Power = 25W.

7. Select the script: ScoutArbTemperature either under Motion Controller Configure or


Motion Controller Events.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 52 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

8. In the script, select a desired sonication ON time. Example: select: Wait -> Event Info ->
5000 ms, to activate the sonication for 5 seconds at each treatment site, and click OK.

9. In the script, select: Get Temperature -> Event Info -> Extra 1, to select the thermocouple
that is connected to Port 1.

10. Define the desired treatment region that would cover the tissue target zone (i.e. a tumor,
for example): Xstart=Ystart=-3, Xstop=Ystop=3, Xincrement=Yincrement=1 mm, as shown
in Figure 2.6.3.1.

Figure 2.6.3.1. Define ablation treatment region

11. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

12. Monitor the progress of the script in different ways: review the temperature map being
displayed during the scan, monitor the temperature of the thermocouple (being displayed in
the Messages window) while TIPS sonifies the various treatment sites, or monitor the
temperature via the scroll display, available by right-clicking on Temperature Readings and
selecting Scroll Display -> Extra 1, as shown in Figure 2.6.3.2.

Figure 2.6.3.2. Ablation monitoring with a thermocouple using the scan map (left), message
window (center), or temperature scrolling display (right)

13. When the scan is completed, right-click on the color bar of the scan to change the
colormap, if desired.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 53 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

- Example 3 (heating a region with ultrasound imaging monitoring) -

1. Enable the joystick and center the transducer assembly and focal area to the desired region
in the tissue.

2. Define a region of interest in the ultrasound image that will be monitored: right-click on
Video Display -> Create View. In the new Interactive Video window, select Ellipse, and
draw/position the ellipse on the desired region in the ultrasound image. TIPS assigns the
defined region a number (Region 2 in the example shown in Figure 2.6.3.3.)

Figure 2.6.3.3. Defining an interactive video region for ultrasound treatment monitoring

3. Define a high-power excitation waveform that will cause a large temperature rise in the
target zone using Waveform -> Generate -> Specify Duty Cycle. Example: Frequency = 1.0
MHz, Duty Cycle = 100%, Acoustic Power = 25W.

4. Select the script: ScoutArbRegionofVideo either under Motion Controller Configure or


Motion Controller Events.

5. In the script, select a desired sonication ON time. Example: select: Wait -> Event Info ->
5000 ms, to activate the sonication for 5 seconds at each treatment site, and click OK.

6. In the script, select: GetRegionMath -> Event Info -> Region 2, Average, to select the
elliptical region defined in the interactive video window, and to compute the average pixel
value over this region when the treatment is being executed, as shown in Figure 2.6.3.4.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 54 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Figure 2.6.3.4. Defining ultrasound imaging event information

7. Define the desired treatment region that would cover the tissue target zone (i.e. a tumor,
for example): Xstart=Ystart=-2, Xstop=Ystop=2, Xincrement=Yincrement=1 mm.

8. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

9. Monitor the progress of the script in different ways: review the result of the ultrasound
image region computation (in pixel brightness) being displayed during the scan, monitor the
actual value of the ultrasound region computation in pixel brightness (being displayed in the
Messages window) while TIPS sonifies the various treatment sites, or monitor the pixel
brightness values via the scroll display, available by selecting on the Interactive Video
Window -> Tools -> Region -> Graph, as shown in Figure 2.6.3.5.

Figure 2.6.3.5. Ablation monitoring with ultrasound imaging with the scan map (left), message
window (center), or region math scrolling display (right)

10. When the scan is completed, right-click on the color bar of the scan to change the
colormap, if desired.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 55 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2.6.4 Protocol 4: Locating and centering on a Thermocouple

Purpose:

Use the TIPS to center/align the focus of the annular array on a thermocouple located within
the target tissue.

Procedure:

1. Place a bare-wire thermocouple within the target region using a cannula, then remove the
cannula to only leave the thermocouple within the target region. Use ultrasound imaging, if
necessary/possible to determine the location of the thermocouple tip within the target
region. Connect the thermocouple to Port 1.

2. Visually align the tip of the acoustic coupler, and try to center it on the thermocouple tip.

3. Define a low-power excitation waveform that will cause a 1-3C temperature rise in the
target zone using Waveform -> Generate -> Specify Duty Cycle. Example: Frequency = 1.0
MHz, Duty Cycle = 100%, Acoustic Power = 2-4W. The goal is to warm the tissue, not to
ablate it.

4. Select the script: DeltaTemperature either under Motion Controller Configure or Motion
Controller Events, as shown in Figure 2.6.4.1.

Figure 2.6.4.1. Selecting the DeltaTemperature script

5. In the script, select: Get Temperature -> Event Info -> Extra 1, to select the thermocouple
that is connected to Port 1.

6. In the script, select a desired sonication ON time. Example: select: Wait -> Event Info ->
1500 ms, to activate the sonication for 1.5 seconds at each treatment site, and click OK.

7. Define a treatment region that would most likely include the thermocouple: Xstart=Ystart=-
3, Xstop=Ystop=3, Xincrement=Yincrement=1 mm.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 56 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

8. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

9. Monitor the progress of the script in different ways: review the temperature map being
displayed during the scan, monitor the temperature difference before- and after sonication
for each location being displayed in the Messages window, or monitor the temperature via
the scroll display, available by right-clicking on Temperature Readings and selecting Scroll
Display -> Extra 1, as shown in Figure 2.6.4.2.

Figure 2.6.4.2. Thermocouple Localization Progress Monitoring using the scan map (left),
message window (center), or temperature scrolling display (right)

10. When the scan is completed, right-click on the color bar of the scan to change the
colormap, if desired.

11. If the thermocouple is located within the treatment region, a clear peak should be present
within the scan, indicating its location relative to the treatment region. If no clear delta
temperature peak is present in the treatment region, increase the treatment region and
repeat the experiment, or increase the amplitude/sonication ON time to elicit a larger
temperature response, and repeat the experiment.

12. If the largest temperature change obtained during this procedure is larger than 1-3C, and
the scan needs to be repeated, it is suggested to either decrease the sonication time or
decrease the acoustic power or pressure to minimize undesired damage to the tissue during
this thermocouple alignment phase.

13. Center the applicator to this peak by selecting Motion Controller -> Mode -> Move Motion
Controller, and then clicking on the location within the scan map. The motion stage will
move the applicator to this new location.

14. Finally, select Motion -> Reset origin, to establish this new position as the x=y=0 location.

15. Note: if the scan is now repeated with the same exposure parameters, the largest
temperature elevation will be located in the center of the scan window, effectively having
centered the applicator on the thermocouple.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 57 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

2.6.5 Protocol 5: Acquiring 3D Ultrasound Imaging Data

Purpose:

Use the TIPS to acquire a 3D ultrasound dataset for later processing and viewing using the 3D
viewer program Microview. Note: use this script only in conjunction with an attached ultrasound
imaging scanner.

Procedure:

1. Select the script: 3DReconstruction either under Motion Controller Configure or Motion
Controller Events, as shown in Figure 2.6.5.1.

Figure 2.6.5.1. Selecting the 3DReconstruction Script

2. Define a 1D scan line along the desired axis. To scan along the Y-axis from -10 mm to 10
mm in 0.5 mm increments, for example, set Xstart=Xstop=0; Xincrement=1; Ystart=-10;
Ystop=10; Yincrement=0.5, as shown in Figure 2.6.5.2.

Figure 2.6.5.2. Defining the 1D scan line

3. Select Motion Controller Scout (or Motion Controller Complete Scan, depending on which
button the 3D reconstruction script was loaded into) to execute the script.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 58 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

4. When prompted, specify a filename for the dataset.

5. TIPS will execute the script, and save one 2D ultrasound image for each location. Images
will be stored in the currently active directory as specified in the Notes Study and Notes
Name field, with the specified filename_####, where #### is a number corresponding to
the acquired image. Note: if you specify the same filename for a subsequent acquisition run,
images acquired earlier will be overwritten. Select a different Notes Name to avoid
overwriting files.

6. Once images have been acquired, use the program Microview to visualize the 3D data (refer
to Appendix E for an overview on Microview).

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 59 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix A: TIPS Functional Block Diagram

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 60 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix B: Preferences and Default Settings


Selecting the submenu Edit->Preferences prompts a Preferences window. There are ten
Preferences tabbed panes: General, Transducer, Acoustic, Motion Controller, AWG, Signal
Test, Trigger, Video, Digitizer and Temperature Monitor.

The General tabbed pane provides general information on the setup of the system:

The Motion Controller tab provides the speed of the motor (with a default value of 10 mm/s)
and settings for its communication with the motion stage via the serial port:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 61 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The Digitizer tab provides configuration for the Analog In port which allows for live capture of
an analog input waveform:

The Transducer tab provides geometrical information for the annular therapy array:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 62 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The AWG tab provides basic information on the internal arbitrary waveform generator:

The Trigger tab allows the user to select either Internal or External triggering. The PRF
for the internal triggering can also be set here:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 63 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

The Video tab allows the selection of the video source: Streaming, WDM Video and From
a file. The default input is WDM Video.

For the protection of the annular array therapy transducer and the power amplifier, certain
limits can be set for the AWG output signal (i.e., the input to the power amplifier). The default
is <= 2.5 Volts:

2.5

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 64 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

On the Temperature Reading pane, the temperature of specific thermocouples can be


monitored in real-time. The program allows these temperatures to be monitored with certain
potential outcomes as defined in the Preferences:

Clicking on the Configure button pops up a new window:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 65 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

On the left column of this configure window there is a list of all possible actions:

1. ShutDown Limits - The temperature above a specific limit would cause the power amplifier to
be turned off as a safety option. The default value is 70C. For the annular array/transducer,
the default value is 45C.

2. Warning - The temperature is monitored and warnings are displayed to the user should the
limit be exceeded. The default value for the annular array/transducer is 35C.

3. Display Temperature - The temperature can be displayed in a separate window.

4. Scrolling Display - The temperature can be monitored while it is being displayed in a


scrollable graph showing the temperature as a function of time. The data can be saved from
this display for later review or processing.

The Acoustic tab allows setting the acoustic properties (speed of sound at a given
temperature) of the propagating medium. This speed of sound is used to adjust the time delays
on the transducer elements to appropriately focus the ultrasound therapy beam. If the value is
changed in this Preference tab, it should also be changed in the General tab under the
velocity entry:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 66 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix C: Degassed Water Procedure


The acoustic coupler must be filled with degassed water during the operation of TIPS. Using
water that is not degassed will cause cavitation bubbles when the ultrasound is activated. These
bubbles typically will migrate to the surface of the array, and adhere to it. If the annular array is
operated in this mode, the matching layer will be damaged due to the acoustic impedance
mismatch between the array surface and the air bubbles.

CAUTION

Activating the therapy or activating the annular array when it is not surrounded with
degassed water will damage it.

If degassed water is not available at your facility, use the following procedure to make
degassed water.

Equipment required:

- Hot Plate (or equivalent)


- Two or more 1L Pyrex bottles with sealing cap (Pyrex Brand 1395 media
storage bottle with screw cap, 1L, Cole Parmer EW-34514-25, or equivalent)

Procedure:

1. Fill the bottles with regular tap water, and place on the hot plate
2. Turn the hot plate on, and allow the water in the bottles to boil
3. Boil the water for AT LEAST 30 MINUTES
4. Turn the hot plate off
5. While still hot, use the boiled water from one bottle to fill the other bottles to the top,
making sure that air bubbles are not created during the filling procedure
6. While still hot, tightly seal the full bottles with the cap
7. Allow the bottles cool down to room temperature

It is important that the bottles are sealed tightly, so as to prevent any air from ingasing the
water in the bottle.

When ready to be used, open the bottle cap. You should hear air hissing back into the bottle
when the bottle is opened. This is a good indication that the cap seal was tight. Verify that the
dissolved O2 content is 3 ppm with the Chemets kit. Pour the degassed water slowly and
carefully into the acoustic coupler, so as to not introduce additional air bubbles into the water.

If you do not hear air hissing back into the bottle when it is being opened, do not use the water
in this bottle.

Alternatively, you may use the stand-alone inline degasser system, which is available as an
accessory to the TIPS system (Part Number AC009). If using this system to degas water, pre-fill

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 67 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

any container up to 1L in size with regular tap water, place the tubing end of the stand-alone
inline degasser system into the container, and energize the degasser. The circulation pump of
the degasser will draw the water through the degassing cartridge, whose outer chamber is
subjected to a vacuum. After approximately 20 minutes, this degasser will have degassed the
water in the container to a dissolved O2 content below 2 ppm, ready for use.

Stand-alone Inline Degasser, P/N AC009

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 68 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix D: Imaging Transducer Alignment Procedure

This procedure is currently being developed and will be available in future releases of this user
manual.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 69 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix E: 3D Image Display


Ultrasound images acquired with TIPS using 3DReconstruction and a connected ultrasound
imaging system can be viewed off-line using the included 3D image viewer Microview.

Procedure:

Launch Microview from the desktop by double-clicking on its icon:

Select File -> Image Import

Navigate to the directory that contains the sequence of 2D ultrasound images acquired with the
3DReconstruction script by selecting (Datafiles are typically located in:
C:\TIPS\support\notes\study name\subject name\date\image filename_####.jpg, where study
name, subject name, and filename are user-selected names for TIPS data archiving). Click on
the first 2D image and select Open.

Specify the spacing and thickness parameters, as well as the number corresponding to the first
and last 2D image. Spacing and thickness parameters will depend on the actual size of the
ultrasound image, and varies from system to system (each 2D image is 640 x 480 pixels in
size). Example: if 1 cm (10 mm) tick mark on the image corresponds to 64 pixels, and the
image was acquired in Y from -10:0.5:10 (41 images), then X Spacing = 0.156, Y Spacing =
0.156, Z Spacing = 0.5 mm, First Number =1, and Last Number = 41:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 70 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Select Import to load in the images.

Once loaded, the dataset can be viewed and manipulated in many different ways. Three of the
most interesting are: 3D rotation, 3D slice selection and 3D transparency.

Select the icon and drag the 3D image with the cursor to rotate it, as desired:

Select the icon, click and hold a desired plane, and drag the cursor to select the
desired slices for viewing:

Select the Tools -> Standard ROI to define a region of interest. Then select Process -> ROI
Blanking -> Blank Outside to remove undesired image data (such as labels, etc.):

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 71 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Select Visualize -> Render Volume, and change the location of the control points on the color
line to the desired transparence level. Select Update to review the transparency changes:

Select Edit -> Application Settings and de-select the axial, coronal, and sagittal planes:

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 72 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

For additional information on how to display and manipulate 3D datasets acquired with TIPS
using Mircoview, select Help -> Microview Help from within Microview.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 73 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix F: Defining Custom Scanning Paths

It is possible to define custom motion/scanning paths for the transducer, which then will be
traversed automatically by the motion control stage in the XY plane. This option is useful, for
example, when treatment paths are desired which are not covered by the pre-defined
rectangular paths. To use this option, a scan file must first be created that contains the desired
coordinates for each treatment site. This scan file has the following format:

ARBFUS SCANFILE
NUMBER [tab] X [tab] Y
[tab] x0 [tab] y0
[tab] x1 [tab] y1

[tab] xn [tab] yn

where the values for x and y are the desired treatment locations, specified in [mm]. An example
of a valid scan file is shown below:

ARBFUS SCANFILE
NUMBER X Y
0 0
0 19.2
0 38.4
0 57.6
0 76.8
19.2 76.8
19.2 57.6
19.2 38.4
19.2 19.2
19.2 0
38.4 0
38.4 19.2
38.4 38.4
38.4 57.6
38.4 76.8
57.6 76.8
57.6 57.6
57.6 38.4
57.6 19.2
57.6 0

This scan file was developed to allow the TIPS transducer to stop on top of each well in a
standard 24-well in-vitro well plate.

Select Motion -> Scan from file as shown in the figure below to select and load the desired
scan file.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 74 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Once loaded, you can preview the scan file contents by selecting Preview from the control
window, specify the dwell time of the transducer at each treatment site with Wait (ms), and
execute the treatment by selecting Scan, as shown in the figure below. The system will follow
this path, and deliver ultrasound energy for the specified time with the parameters defined in
the waveform window.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 75 of 76


V1.3 12/03/2008
Philips Research
TIPS User Manual for V1.2

Appendix G: Known Bugs


The following is a list of currently known bugs, to be fixed in the next release of the TIPS
application software.

Problem: When loading in waveforms from a file, even if clearing all previously stored
waveforms from memory, the loaded waveform is appended to an empty waveform,
preventing it from being executed.
Solution: delete the empty waveform by right-clicking on Waveform -> Advanced, then
selecting the empty waveform from the list, and clicking Delete.

TIPS_007 User Manual for SW 1.2 (v1.3).doc Page 76 of 76


V1.3 12/03/2008

Вам также может понравиться