`Pflugrath et al.
`
`1111111111 m 11111111111111111111111111111
`US005722412A
`5,722,412
`[HJ Patent Number:
`[451 Date of Patent:
`Mar. 3, 1998
`
`(54] HAND HELD ULTRASONIC DIAGNOSTIC
`INSTRUMENT
`
`(75]
`
`Inventors: Lauren S. Pftugrath. Seattle; Jacques
`Souquet. Issaquah, both of Wash.
`
`(73) Assignee: Advanced Technology Laboratories,
`Inc .. Bothell, Wash.
`
`5,590,658
`
`1/1997 Clliang et al ...................... 128/661.01
`
`OfHER PUBLICATIONS
`
`Minivisor Service Manual from Organon Teknika (Sep.
`1979).
`Ultra PO System Specifications from Advanced Medical
`Products of Columbia. South Carolina (date unknown).
`
`[21) Appl. No.: 672,782
`Jun. 28, 1996
`
`[22) Filed:
`Int. Cl.6
`........................................................ A61B 8/00
`[51)
`[52) U.S. Cl. ......................................................... 128/662.03
`[58] Field of Search ......................... 128/660.07. 660.08,
`128/660.01. 661.1, 660.09. 662.03. 660.04.
`660.05. 661.08. 661.09
`
`[56]
`
`References Cited
`
`U.S. PpJENT DOCUMENTS
`
`Primary Examiner-George Manuel
`Attorney, Agent, or Firm-W. Brinton Yorks, Jr.
`
`[57)
`
`ABSTRACT
`
`A hand held ultrasonic instrument is provided in a portable
`unjt which performs both B mode lU}d Doppler imaging. In
`a preferred embodiment an array transducer, digital
`beamformer, digital filter. and image processor are packaged
`in one or more enclosures weighing ten pounds ( 4.5
`kilograms) or less.
`
`5,295,485
`
`3/1994 Shinomura et al ................ 128/66().07
`
`24 Claims, 19 Drawing Sheets
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`Mar. 3, 1998
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`Exhibit 1012 page 6 of 32
`DENTAL IMAGING
`
`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 6 of 19
`
`5,722,412
`
`FIG.7
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`Exhibit 1012 page 9 of 32
`DENTAL IMAGING
`
`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 9 of 19
`
`5,722,412
`
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`Exhibit 1012 page 10 of 32
`DENTAL IMAGING
`
`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 10 of 19
`
`5,722,412
`
`FIG.11
`
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`Exhibit 1012 page 11 of 32
`DENTAL IMAGING
`
`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 11 of 19
`
`5,722,412
`
`FIG.12
`
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`U.S. Patent
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`Mar. 3, 1998
`
`Sheet 13 of 19
`
`5,722,412
`
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`Exhibit 1012 page 14 of 32
`DENTAL IMAGING
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`U.S. Patent
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`Mar. 3, 1998
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`Sheet 14 of 19
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`Mar. 3, 1998
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`Mar. 3, 1998
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`U.S. Patent
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`Mar. 3, 1998
`
`Sheet 17 of 19
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`5,722,412
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`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 18 of 19
`
`5,722,412
`
`0019
`
`Exhibit 1012 page 19 of 32
`DENTAL IMAGING
`
`
`
`U.S. Patent
`
`Mar. 3, 1998
`
`Sheet 19 of 19
`
`5,722,412
`
`FIG.22
`
`NUMBER OF
`CONTACTS
`
`SWITCH FUNCTION
`
`DESCRIPTION
`c::::> SLIDE SWITCH
`POWER OFF/ON
`ACTIVE SCAN/FREEZE Q
`0
`CPA
`DOPPLER/CPA FILTER Q
`
`3D IMAGING MODE
`
`0
`
`PUSHANDHOLDFORACTIVESCAN
`ENABLES AND DISABLES COLOR POWER
`ANGIOCPA
`HIGH/MEDIUM/LOW BUTTON CYCLES
`THROUGH 3 SELECTIONS
`ENABLES 3D CAPTURE WHEN ENGAGED
`BEFORE THE ACTIVE SCAN BUTTON
`IS PUSHED
`
`1
`
`1
`
`1
`
`1
`
`1
`
`4
`
`1
`
`1
`
`1
`
`2
`
`
`SENDS SERIAL SIGNAL TO PRINTER
`
`X/Y POSITION OF CURSOR
`
`Q
`CURSOR POSITION IOkf 1
`0
`
`ENTER
`
`0
`
`0
`
`0
`
`MENU
`
`MEASURE
`
`FOCUS
`
`IMAGE
`
`ENTERS SELECTION
`TOGGLES MENU FUNCTIONS OFF AND
`ON,USES CURSOR AND ENTER. FUNCTIONS:
`APPLICATION SELECTION USED TO ENTER 1
`ALPHA NUMERIC DATA,PATIENT ID,
`PATIENT NAME, CINE 20 AND 30 REVIEW
`ENABLES MEASUREMENTS, USES
`CURSOR AND ENTER
`ENABLES FOCUS MODE, CURSOR UP
`DOWN POSITIONS FOCUS, CURSOR LEFT
`RIGHT SELECTS NUMBER OF ZONES
`ALLOWS THE USER TO SELECT THROUGH
`SEVERAL GRAY SCALE CURVES, SPATIAL
`AND TEMPORAL FILTERS WITH IN A
`PREDETERMINED SET OF SETUPS FOR
`A SELECTED APPLICATION
`
`DEPTH
`
`UP/DOWN, 5 DEPTH SELECTIONS
`
`TGC GAIN
`
`UP/DOWN
`
`BRIGHTNESS
`
`LCD DISPLAY CONTROL UP/DOWN
`
`CONTRAST
`
`LCD DISPLAY CONTROL UP/DOWN
`
`2
`
`2
`
`2
`
`2
`
`0020
`
`Exhibit 1012 page 20 of 32
`DENTAL IMAGING
`
`
`
`5,722,412
`
`1
`HAND HELD ULTRASONIC DIAGNOSTIC
`INSTRUMENT
`
`10
`
`30
`
`This invention relates to medical ultrasonic diagnostic
`systems and, in particular. to a fully integrated hand held 5
`ultrasonic diagnostic instrument.
`As is well known. modern ultrasonic diagnostic systems
`are large. complex instruments. Today's premium ultra(cid:173)
`sound systems. while mounted in carts for portability. con(cid:173)
`tinue to weigh several hundred pounds. In the past. ultra-
`sound systems such as the ADR 4000 ultrasound system
`produced by Advanced Technology Laboratories. Inc .•
`assignee of the present invention, were smaller. desktop
`units about the size of a personal computer. However. such
`instruments lacked many of the advanced features of today's
`premium ultrasound systems such as color Doppler imaging 15
`and three dimensional display capabilities. As ultrasound
`systems have become more sophisticated they have also
`become bulkier.
`However. with the ever increasing density of digital
`electronics. it is now possible to foresee a time when 20
`ultrasound systems will be able to be miniaturized to a size
`even smaller than their much earlier ancestors. The physi(cid:173)
`cian is accustomed to working with a hand held ultrasonic
`scanhead which is about the size of an electric razor. It
`would be desirable, consistent with the familiar scanhead, to 25
`be able to compact the entire ultrasound system into a
`scanhead-sized unit. It would be further desirable for such an
`ultrasound instrument to retain as many of the features of
`today's sophisticated ultrasound systems as possible, such as
`speckle reduction. color Doppler and three dimensional
`imaging capabilities.
`In accordance with the principles of the present
`invention. a diagnostic ultrasound instrument is provided
`which exhibits many of the features of a premium ultrasound
`system in a hand held unit. The instrument can be produced
`as a single unit or. in a preferred embodiment. the instrument 35
`is a two-part unit, one including a transducer. beamformer,
`and image processor and the other including a display and
`power source for both units. In such a configuration the
`transducer/processor unit can be manipulated with one hand
`while a cable between the two units enables the video to be 40
`shown on the display unit while the latter unit is held or
`positioned for optimal viewing of the ultrasound image. The
`cable also provides energy for the transducer/processor unit
`from the display unit.
`In a preferred embodiment the ultrasound system. from 45
`the transducer through to a video output. is fabricated on
`four types of application specific integrated circuits
`(ASICs ): a transmit/receive ASIC which is connected to the
`elements of an array transducer. a front end ASIC which
`performs and controls transmit and receive beamforming. a 50
`digital signal processing ASIC which provides processing of
`the ultrasound signals such as filtering. and a back end ASIC
`which receives processed ultrasound signals and produces
`ultrasound image data. The image can be displayed on either
`a standard monitor or on a liquid crystal display (LCD). 55
`Comprised as it is of ASICs. the electronics of the unit can
`be fabricated on a single printed circuit board, eliminating
`the problems conventionally posed by connectors and
`cables. This sophisticated ultrasound instrument can be
`manufactured as a hand held unit weighing less than five 60
`pounds.
`In the drawings:
`FIG. 1 illustrates in block diagram form the architecture
`of a hand-held ultrasound system of the present invention;
`FIGS. 2a and 1h are front and side views of a hand-held 65
`ultrasound system of the present invention which is pack(cid:173)
`aged as a single unit;
`
`2
`FIGS. 3a and 3b are front and side views of the trans(cid:173)
`ducer unit of a two-unit hand-held ultrasound system of the
`present invention;
`FIG. 4 illustrates the two units of a hand-held ultrasound
`system of the present invention in a two-unit package;
`FIG. 5 is a schematic diagram of the transmit/receive
`ASIC of the ultrasound system of FIG. l;
`FIG. 6 is a block diagram of the front end ASIC of the
`ultrasound system of FIG. l;
`FIG. 7 illustrates the aperture control afforded by the
`transmit/receive and front end ASICs;
`FIG. 8 is a block diagram of the digital signal processing
`ASIC of the ultrasound system of FIG. l;
`FIG. 9 illustrates a min-max filter for flash suppression;
`FIG. lOa-lOc are waveforms illustrating the operation of
`the flash suppression processor;
`FIG. 11 is a flowchart of B mode processing by the digital
`signal processing ASIC;
`FIG. 12 is a flowchart of Doppler processing by the
`digital signal processing ASIC;
`FIG. 13 is a block diagram of the back end ASIC of the
`ultrasound system of FIG. l;
`FIG. 14 illustrates R0 scan conversion in accordance
`with the present invention;
`FIG. 15 illustrates scanline interpolation by the scan
`converter;
`FIG. 16 is a further illustration of scan conversion in
`accordance with the present invention;
`FIG. 17a and 17b illustrate combined B mode and
`Doppler images;
`FIG. 18 illustrates combined B mode and Doppler scan(cid:173)
`lines;
`FIGS. 19 and 20 illustrate three dimensional rendering
`using two dimensional image frames;
`FIG. 21 illustrates the partitioning of the frame buffer
`memory during three dimensional imaging; and
`FIG. 22 is a chart of the user controls of the ultrasound
`system of FIG. 1.
`Referring first to FIG. 1. the architecture of a hand-held
`ultrasound system of the present invention is shown. It is
`possible to package an entire ultrasound system in a single
`hand-held unit only through judicious selection of functions
`and features and efficient use of integrated circuit and
`ultrasound technology. A transducer array 10 is used for its
`solid state, electronic control capabilities, variable aperture.
`image performance and reliability. Either a flat or curved
`linear array can be used. In a preferred embodiment the array
`is a curved array, which affords a broad sector scanning field.
`While the preferred embodiment provides sufficient delay
`capability to both steer and focus a flat array such as a
`phased array. the geometric curvature of the curved array
`reduces the delay requirements on the beamformer. The
`elements of the array are connected to a transmit/receive
`ASIC 20 which drives the transducer elements and receives
`echoes received by the elements. The transmit/receive ASIC
`30 also controls the transmit and receive apertures of the
`array 10 and the gain of the received echo signals. The
`transmit/receive ASIC is preferably located within inches of
`the transducer elements, preferably in the same enclosure.
`and just behind the transducer.
`Echoes received by the transmit/receive ASIC 20 are
`provided to the adjacent front end ASIC 30, which beam(cid:173)
`forms the echoes from the individual transducer elements
`into scanline signals. The front end ASIC 30 also controls
`the transmit waveform, timing. aperture and focusing. In the
`illustrated embodiment the front end ASIC 30 provides
`timing signals for the other ASICs. time gain control. and
`
`0021
`
`Exhibit 1012 page 21 of 32
`DENTAL IMAGING
`
`
`
`5,722,412
`
`3
`monitors and controls the power applied to the transducer
`array, thereby controlling the acoustic energy which is
`applied to the patient and minimizing power consumption of
`the unit. A memory device 32 is connected to the front end
`ASIC 30. which stores data used by the beamformer.
`Beamformed scanline signals are coupled from the front
`end ASIC 30 to the adjacent digital signal processing ASIC
`40. The digital signal processing ASIC 40 filters the scanline
`signals and in the preferred embodiment also provides
`several advanced features including synthetic aperture 10
`formation. frequency compounding. Doppler processing
`such as power Doppler ( color power angio) processing. and
`speckle reduction.
`The ultrasound B mode and Doppler information is then
`coupled to the adjacent back end ASIC 50 for scan conver(cid:173)
`sion and the production of video output signals. A memory
`device 42 is coupled to the back end ASIC 50 to provide
`storage used in three dimensional power Doppler (3D CPA)
`imaging. The back end ASIC also adds alphanumeric infor(cid:173)
`mation to the display such as the time. date. and patient
`identification. A graphics processor overlays the ultrasound
`image with information such as depth and focus markers and
`cursors. Frames of ultrasonic images are stored in a video
`memory 54 coupled to the back end ASIC 50, enabling them
`to be recalled and replayed in a live Cineloop@ realtime
`sequence. Video information is available at a video output in
`several formats. including NfSC and PAL television for(cid:173)
`mats and RGB drive signals for an LCD display 60 or a
`video monitor.
`The back end ASIC SO also includes the central processor
`for the ultrasound system. a RISC (reduced instruction set
`controller) processor. The RISC processor is coupled to the
`front end and digital signal processing ASICs to control and
`synchronize the processing and control functions throughout
`the hand-held unit A program memory 52 is coupled to the
`back end ASIC 50 to store program data which is used by the
`RISC processor to operate and control the unit The back end
`ASIC 50 is also coupled to a data port configured as a
`PCMCIA interface 56. This interface allows other modules
`and functions to be attached to the hand-held ultrasound
`unit. The interface 56 can connect to a modem or commu(cid:173)
`nications link to transmit and receive ultrasound information
`from remote locations. The interface can accept other data
`storage devices to add new functionality to the unit. such as
`an ultrasound information analysis package.
`The RISC processor is also coupled to the user controls
`70 of the unit to accept user inputs to direct and control the
`operations of the hand-held ultrasound system.
`Power for the hand-held ultrasound system in a preferred
`embodiment is provided by a rechargeable battery. Battery 50
`power is conserved and applied to the components of the
`unit from a power subsystem 80. The power subsystem 80
`includes a DC converter to convert the low battery voltage
`to a higher voltage which is applied to the transmit/receive
`ASIC 20 to drive the elements of the transducer array 10.
`FIGS. 2a and 2b illustrate a one piece unit 80 for housing
`the ultrasound system of FIG. 1. The front of the unit is
`shown in FIG. 2a. including an upper section 83 which
`includes the LCD display 60. The lower section 81 includes
`the user controls as indicated at 86. The user controls enable
`the user to turn the unit on and off. select operating char(cid:173)
`acteristics such as the mode (B mode or Doppler). color
`Doppler sector or frame rate. and special functions such as
`three dimensional display. The user controls also enable
`entry of time. date. and patient data. A four way control.
`shown as a cross. operates as a joystick to maneuver cursors
`on the screen or select functions from a user menu. Alter-
`
`4
`natively a mouse ball or track pad can be used to provide
`cursor and other controls in multiple directions. Several
`buttons and switches of the controls are dedicated for
`specific functions such as freezing an image and storing and
`5 replaying an image sequence from the Cineloop memory.
`At the bottom of the unit 80 is the aperture 84 of the
`curved transducer array 10. In use. the transducer aperture is
`held against the patient to scan the patient and the ultrasound
`image is displayed on the LCD display 60.
`FIG. 2h is a side view of the unit 80. showing the depth
`of the unit. The unit is approximately 20.3 cm high, 11.4 cm
`wide, and 4.5 cm deep. This unit contains all of the elements
`of a fully operational ultrasound system with a curved array
`transducer probe. in a single package weighing less than five
`15 pounds. A major portion of this weight is attributable to the
`battery housed inside the unit.
`FIGS. 3 and 4 illustrate a second packaging configuration
`in which the ultrasound system is housed in two separate
`sections. A lower section 81 includes the transducer array.
`20 the electronics through to a video signal output. and the user
`controls. This lower section is shown in FIG. 3a. with the
`curved transducer array aperture visible at the bottom. The
`lower section is shown in the side view of FIG. 3b. This
`lower section measures about 11.4 cm high by 9.8 cm wide
`25 by 2.5 cm deep. This unit has approximately the same
`weight as a conventional ultrasound scanhead. This lower
`section is connected to an upper section 83 as shown in FIG.
`4 by a cable 90. The upper section 83 includes an LCD
`display 82 and a battery pack 88. The cable 90 couples video
`30 signals from the lower unit 81 to the upper unit for display.
`and provides power for the lower unit from the battery pack
`88. This two part unit is advantageous because the user can
`maneuver the lower unit and the transducer 84 over the
`patient in the manner of a conventional scanhead. while
`35 holding the upper unit in a convenient stationary position for
`viewing. By locating the battery pack in the upper unit. the
`lower unit is lightened and easily maneuverable over the
`body of the patient.
`Other system packaging configurations will be readily
`40 apparent. For instance. the front end ASIC 30. the digital
`signal processing ASIC 40. and the back end ASIC SO could
`be located in a common enclosure. with the beamformer of
`the front end ASIC connectable to different array transduc(cid:173)
`ers. This would enable different transducers to be used with
`45 the digital beamformer. digital filter. and image processor
`for different diagnostic imaging procedures. A display could
`be located in the same enclosure as the three ASICS. or the
`output of the back end ASIC could be connected to a
`separate display device.
`Referring now to FIG. S. the transmit/receive ASIC 20 is
`shown in greater detail. This ASIC is comprised of sixteen
`sections. each of which is coupled to six transducer elements
`of the array 10. The illustrated section 20a is coupled to
`elements 1. 17. 33. 49, 65 and 81 at the terminals on the left
`55 side of the drawing. With six elements per section. the entire
`ASIC can operate with a 96 element transducer. Each section
`could be configured to operate with eight elements. in which
`case the ASIC could control a 128 element transducer. for
`instance. Prior to the transmission of an ultrasonic pulse for
`60 a scanline. a serial stream of data from the front end ASIC
`30 is clocked into transmit aperture select logic 206 at the
`Transmit Data In and Clk terminals at the right side of the
`drawing. The transmit aperture select logic 206 uses this
`data to set multiplexer switches in 3: 1 transmit muxes 208
`65 and 210 for the transducer elements that will be active for
`the particular scanline. For instance. the next scanline to be
`transmitted may have a transmit aperture comprising ele-
`
`0022
`
`Exhibit 1012 page 22 of 32
`DENTAL IMAGING
`
`
`
`5,722,412
`
`5
`ments 1-32. This requires that transmit mux 208 closes a
`switch to connect pulser 202 to the element 1 terminal. and
`the transmit mux 210 closes a switch to connect pulser 204
`to the element 17 terminal. In a similar manner the transmit
`muxes in the other fifteen sections of the ASIC will connect
`pulsers to element tenninals 2-16 and 18-32.
`At the times when the connected elements 1 and 17 are
`to be activated. drive signals for the pulsers 202 and 204 are
`applied to the Signal 1 In and Signal 2 In terminals by the
`front end ASIC. For unipolar pulsers the drive signals may 10
`be applied to these terminals. then the pulsers are enabled at
`the appropriate times by signals applied to the enable 1 and
`enable 2 terminals. Alternatively. complementary wave(cid:173)
`forms are applied at the appropriate times to the paired
`terminals. These drive signals are applied as logic level 15
`signals to the pulser inputs, then converted to high voltage
`driving waveforms by the application of high voltage HV
`applied to the muxes 208 and 210. It is also possible to
`fabricate the pulser and rnux functions as a single unit.
`whereby each switch of the muxes is effectively a high 20
`voltage pulser. Stated another way. this means that each mux
`would comprise three separately controlled pulsers.
`Alternatively, the two pulsers at the inputs of the transmit
`muxes could be deleted and replaced by six pulsers at the
`outputs of the transmit muxes, however. the illustrated 25
`embodiment advantageously requires only two. low voltage
`pulsers. Continuing with the example of the aperture of
`elements 1-32, if element 1 is at the periphery of the
`aperture and element 17 is more central to the aperture.
`element 1 would be pulsed earlier in time than element 17 30
`to produce a focused transmitted ultrasonic waveform.
`Prior to transmission of the scanline a stream of digital
`data from the front end ASIC is clocked into receive aperture
`select logic 214 from the Receive Data In and Clk terminals
`connected to logic 214. The receive aperture select logic 35
`closes switches in a 6:1 receive mux 212 and a 1:8 receive
`mux 218 for the proper receive aperture. Like the transmit
`aperture select logic, the receive aperture select logic
`includes buffer storage so that data for the next scanline can
`be received while the ASIC is receiving echoes from the 40
`current scanline. The illustrated embodiment is designed for
`a sixteen element folded receive aperture as shown by the
`eight data bus lines at the output of the 1:8 receive mux 218.
`The inputs to the 6: 1 receive mux 212 are connected to the
`six element terminals for section 201 and are protected from 45
`the high drive voltages by the integration of transmit/receive
`networks at the mux inputs. The receive aperture select logic
`214 connects one of the inputs of the mux 212 to the mux
`output. and the received signal from the selected element is
`applied to a first time gain control (TGC) amplifier 216. The 50
`gain of this TGC amplliier is controlled by a control signal
`applied to a TGC Control terminal of the ASIC. The ampli(cid:173)
`fication provided by amplifier 216 increases as ultrasonic
`echoes are received from increasing depths, in the conven(cid:173)
`tional manner. The amplliied echo signals are then coupled 55
`by the switching of the 1 :8 receive mux 218 to one of the
`data bus lines 220.
`Each of the data bus lines 220 is coupled to the same
`corresponding output of every 1 :8 receive mux on the ASIC.
`The outputs of the mux 218 are numbered from 1-8. Output
`1 of each 1:8 receive mux is coupled to the same one of the
`data lines; output 2 of each 1:8 receive mux is coupled to
`another one of the data lines; and so forth. The preferred
`embodiment system uses a sixteen element folded aperture
`of scanlines transmitted orthogonal to the transducer. This
`means that two elements of the aperture will have the same
`receive phases of operation; the sixteen elements of the
`
`6
`receive aperture will be paired to have eight receive phases.
`For instance. if the received scanline is located at the center
`of an aperture of elements 1-16, elements 1 and 16 will have
`the same receive timing. Echoes received by element 1 will
`5 be connected through mux 212. amplified by TGC amplifier
`216, connected through mux. 218 and produced as a current
`output at output 8 of the mux 218. At the same time. an echo
`received by element 16 will be connected through the muxes
`of another section of the ASIC. identically amplified by
`another TGC amplifier. and produced as a current output at
`output 8 of another 1:8 receive mux. These two currents are
`identically phased by virtue of the folded aperture, and
`combine on the data line which is coupled to output 8 of the
`receive muxes.
`The currents on each data line are filtered and converted
`to voltages by a filter network such as that shown at 222. In
`the preferred embodiment filter network 222 is external to
`and coupled to a terminal of the ASIC so that its components
`and hence its filter characteristic can be easily selected and
`changed. The filter characteristic is a bandpass chosen to
`match the passband of the transducer. For a 3.5 MHz
`transducer the passband could extend from 1.5 to 5.5 MHz.
`for example. The filter is connected to a current source
`through the filter impedance to convert the current signals to
`a single voltage. This voltage reenters the ASIC through
`another ( or the same) ASIC terminal and is applied to the
`input of a second TGC amplifier 224. The use of two TGC
`amplifiers enables operation over the wide dynamic range of
`the two cascaded amplifiers. In the illustrated embodiment a
`single T