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        Handheld ultrasound imaging systems
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1.      0091  Where acomponent  e g  a processor  circuit  beam   former  signal conditioner  filter  control  assembly  device   circuit  etc   is referred to above  unless otherwise indicated   reference to that component  including a reference to a     means        should be interpreted as including as equivalents of  that component any component which performs the function    US 2012 0232380 Al    of the described component  i e   that is functionally equiva   lent   including components which are not structurally  equivalent to the disclosed structure which performs the func   tion in the illustrated exemplary embodiments of the inven   tion  The embodiments described above and depicted in the  Figures are examples only  Features of those embodiments  may be combined in ways other than those expressly set out  herein     0092  While a number of exemplary aspects and embodi   ments have been discussed above  those of skill in the art will  recognize certain modifications  permutations  additions and  sub combinations thereof  It is therefore intended that the  following appended claims and claims hereafter introduced  are interpreted to include all such modifications  permuta   tions  additions and sub combinations as are within their true  spirit and scope    What is claimed is    1  A hand holdable ultrasound system comprising    a detachable transducer assembly comprising a plurality of  transducer elements  the transducer assembly inter   changeable with one or more othe
2.    TRANSMIT    a pesca  FIG 6A    14    14       FIG 6B    US 2012 0232380 Al    HANDHELD ULTRASOUND IMAGING  SYSTEMS    REFERENCE TO RELATED APPLICATIONS     0001  This application is a continuation of U S  patent  application Ser  No  12 188 122 filed 7 Aug  2008  which  claims the benefit under 35 U S C    119 of U S  patent appli   cation No  60 977 353 filed 3 Oct  2007  all of which are  entitled HANDHELD ULTRASOUND IMAGING SYS   TEMS and are hereby incorporated by reference  This appli   cation claims the benefit under 35 U S C    120 of U S  patent  application Ser  No  12 188 122 filed 7 Aug  2008 and entitled  HANDHELD ULTRASOUND IMAGING SYSTEMS     TECHNICAL FIELD     0002  This invention relates to medical monitoring sys   tems  The invention relates particularly to systems which  apply ultrasound to detect physiological features or charac   teristics of a subject  Embodiments of the invention provide  handheld ultrasound imaging devices     BACKGROUND     0003  Ultrasound imaging systems are used in medicine to  explore internal areas of a subject   s body  Ultrasonic imaging  is non destructive and versatile and can provide high quality  diagnostic images     0004  A typical medical ultrasound imaging system has a  transducer  a custom built electronic controller  and a user  interface  The transducer typically comprises an array of at  least several regularly spaced piezoelectric transducer ele   ments  The transducer elements may be arranged in any of  several
3.  an  image  one or both of the line placement configuration  data and the line placement software comprising param   eters for generating guidelines on the display to indicate  a desired placement of a needle   2  The hand holdable ultrasound system according to claim  1 wherein the hand holdable ultrasound system weighs less  than 10 pounds and has transverse and longitudinal dimen   sions less than about 15 centimetres and a width less than  about 5 centimetres     3  The hand holdable ultrasound system according to claim  1 wherein each of the sets of configuration data provides    a specific configuration of the signal processing unit and  the transmit pulsers to generate specific ultrasound sig   nals and to process resulting reflected signals detected at  the transducer assembly to provide ultrasound images  appropriate to the corresponding operational mode    user interface controls which are specific to the corre   sponding operational mode  and   help functions specific to the corresponding operational  mode to assist users in properly using the ultrasound    US 2012 0232380 Al    system in the corresponding operational mode  the help  functions comprising images and videos for display on  the display    4  The hand holdable ultrasound system according to claim  1 wherein the ultrasound system comprises a set of transducer  assemblies and the detachable transducer assembly is one of  the set of transducer assemblies  the set of transducer assem   blies comprising a f
4.  configured  In the illustrated embodiment  line  placement software executes on processor unit 16A and sig   nal processing unit 18A is configured in such a manner as to  provide line placement imaging sequence and guide func   tions  In this operational mode  signal processing unit 18A  may be configured with beamforming coefficients that result  in enhanced visibility in an image 66 of a needle 66B or the  like  FIG  5B  being inserted into a subject     0086  FIG  5B shows an example of an image 66 which  could be provided on display 14 during operation of device 10  when it is in the line placement operational mode of FIG  5A   Image 66 includes depictions 66A of various anatomical  structures in the subject  an image of a needle or probe 66B   and generated guide lines 66C which indicate a desired place   ment of the needle or probe  Parameters used to generate  guidelines 66C may be specified in configuration data and or  in software executing on processor unit 16     0087  FIG  6A illustrate a device 10 configured to operate  in a labour and delivery operational mode which is intended  for monitoring the labour or pregnant women and the delivery  of babies in obstetric applications and FIG  6B shows an  example of a resulting image 68 which may be provided on  display 14 when device 10 is so configured  In this embodi   ment  processor unit 16B is configured to execute labour and  delivery software and signal processing unit 18B is config   ured to generate ultrasound
5.  configured to configure the signal  processing unit to read configuration data for subsequent  ultrasound image lines into the buffer from the memory while  a current ultrasound image line is being processed according  to the configuration data for the current ultrasound image line  that is in the buffer    13  The hand holdable ultrasound system according to  claim 11 wherein the buffer comprises a circular buffer    14  The hand holdable ultrasound system according to  claim 1 wherein for each of the plurality of operational  modes  timing  phases  and intensities of the driving signals  delivered to the transducer assembly are controlled by the  signal processing unit which has been configured for the  current operational mode by the processor unit    15  The hand holdable ultrasound system according to  claim 1 wherein for at least one of the operational modes the  signal processing unit is configured to perform envelope  detection on the signals received from the transducer assem   bly    16  The hand holdable ultrasound system according to  claim 15 wherein the signal processing unit is configurable to  provide an envelope detection algorithm from among a plu   rality of different envelope detection algorithms by program   ming interconnects within a section of the field program   mable gate array that implements one or more envelope  detectors arranged to act on the received signals    17  The hand holdable ultrasound system according to  claim 1 wherein the ultrasoun
6.  different geometries  depending upon the medical  application for which the transducer will be used     0005  The controller drives the transducer to emit ultra   sound signals and collects and processes data from the trans   ducer to provide  store  display and manipulate images  The  user interfaces for typical ultrasound imaging systems typi   cally include various input output devices which allow a user  to control the operation of the imaging system  The input   output devices typically comprise at least a control panel  a  video display  and a printer     0006  The electronic controller can send and receive elec   tric signals to and from any of the transducer elements  To  create a diagnostic image  the controller transmits electrical  excitation signals to the transducer elements  The transducer  elements convert the excitation signals into ultrasonic vibra   tions  which are transmitted into the subject   s body  The ultra   sonic vibrations typically have frequencies in the range of  about 2 MHz to about 12 MHz  The ultrasonic vibrations are  scattered and reflected by various structures in the subject   s  body  Some of the reflected and or scattered ultrasonic vibra   tions  which may be called echoes  are received at the trans   ducer  The echoes cause the transducer elements to generate  electrical signals  After the excitation signals have been trans   mitted the controller receives and processes the electric sig   nals from the transducer elements     0007  T
7.  may be configured to permit the use of interchangeable trans   ducer assemblies 20 that may be removed and replaced with  different transducer assemblies suitable for different opera   tional modes  For example  device 10 may be configured as  described in U S  Patent Application No  60 955 325 entitled  Hand held Ultrasound Imaging Device Having Removable  Transducer Arrays  filed on 10 Aug  2007  or its counterpart  US non provisional application of the same title  filed on the  same date as the instant application  both of which are hereby  incorporated herein by reference     0064  In such cases  device 10 may be configured so that it  automatically switches between operational modes in  response to detecting that a transducer assembly 20 has been  changed to a different type of transducer assembly  In the  alternative  device 10 can perform a routine to detect the type  of connected transducer assembly 20  either on initialization  or at some other time and can select an appropriate opera   tional mode based upon information identifying the type of  transducer assembly 20 identified in the initialization routine    0065  FIGS  2A  2B and 2C show  for example  a device 10  to which different transducer assemblies 20  20A and 20B  have been attached respectively  A different operational mode  may correspond to each of transducer assemblies 20  20A and  20B  Device 10 may be switched between these operational  modes by selecting and installing the corresponding trans   duc
8.  mode  the software configured to  cause the processor unit to perform one or more of   filtering  envelope detection  log compression  and auto   correlation     the set of configuration data for at least one of the opera   tional modes is configured to configure the signal pro   cessor unit to pass RF data to the processor unit at a rate  that is two or more times a frequency of the ultrasound  signals and to configure the processor unit to perform  further processing to derive image data from the RF data  by one or more of  fast Fourier transform of the RF data  and auto correlation     the set of configuration data for at least one of the opera   tional modes is configured to configure the signal pro   cessor unit to provide a transmit beamformer and a  receive beamformer  the transmit beamformer and  receive beamformer having different numbers of chan   nels     the plurality of operational modes comprises a line place   ment operational mode  one of the sets of configuration  data comprises line placement configuration data  and  the ultrasound system is configured according to the line  placement configuration data to provide imaging that is  optimized for guiding a needle into a tissue or another  physiological structure  the line placement configura   tion data specifying line placement software to be  executed by the processor unit and configured to config   ure the signal processing unit with beamforming coeffi   cients to provide enhanced visibility of a needle in
9.  patterns of contact between a  user   s finger  or a stylus and display 14      0055  A benefit of the architecture described herein is that  it permits the same hardware to be configured in different  manners  e g  different operational modes  so as to provide  different specialized imaging functions  For example  ultra   sound device 10 may be configured to provide imaging suit   able for use in monitoring a fetus prior to and during labour  and delivery  The same device 10 may be configured differ   ently to provide imaging that is optimized for guiding a  needle  such as a needle for taking a biopsy or some other type  of needle into a tissue or other physiological structure of  interest  Other operational modes may be provided for some  other specific purposes      0056  Each operational mode may have associated with it  a number of different elements  These may include  for  example      0057  specific configurations of signal processing unit  18 and or transmit pulsers 22 to generate specific ultra   sound signals and to process resulting reflected signals  detected at transducer assembly 20 in such a way as to  provide ultrasound images appropriate to the opera   tional mode      0058  user interface controls which are specific to the  operational mode      0059  various help functions provided by device 10  which are specific to the operational mode to assist users  in properly using device 10 in the operational mode      0060  The ability to configure a single hard
10.  signals and process detected  ultrasound signals in ways suitable for providing good quality  images of a fetus in utero and or in the birth canal     0088  A device 10 may usefully include features as  described in co pending U S  Application No  60 955 329  entitled Power Management in Portable Ultrasound Devices   filed on 10 Aug  2007  or its counterpart US non provisional  application of the same title  filed on the same date as the  instant application  both of which are hereby incorporated  herein by reference  These applications describe the use of  configuration data to place an ultrasound device in different  operational modes as well as to use configuration data to place  the ultrasound device in various power consumption modes    0089  As discussed above  signal processing unit 18 may  comprise an FPGA  Advantageously  the same FPGA may be  configured to both generate control signals for transmit  pulsers 22 and to provide processing of detected signals  received from elements of transducer assembly 20  Providing  both of these functions in a single FPGA is advantageous  because it reduces the width of the signal path required  between processor unit 16 and signal processing unit 18    0090  Example embodiments of the invention may be  made from readily available off the shelf components as con   trasted with custom circuitry such as complicated application  specific integrated circuits  ASICS  which are required to  provide specialized functions in other devices
11.  that have been  reflected from within the subject and processes those ultra   sound signals to yield an image     0036  Device 10 comprises a display 14 upon which an  image may be displayed  a processor unit 16 which may  comprise a data processor  memory and associated operating  system  and a configurable signal processing unit 18  Under  the control of processor unit 16  signal processing unit 18 may  be configured to provide signal processing appropriate to  different operational modes     0037  Some examples of different operational modes are  modes tailored to     0038  obtaining at least basic information about fetus  position prior to and during delivery in labour and deliv   ery rooms     0039  monitoring a position of a needle in biopsy line  placement and optionally providing a biopsy guide dis   play     0040  screening for conditions such as Abdominal Aor   tic Aneurysm  and     0041  the like     0042  Device 10 optionally includes a stored user manual  and or a stored audio and or visual user guide that can be  played to a user on device 10  The user manual and user guide  may explain use of device 10 in the current operational mode    0043  When device 10 is operating in an operational mode   processor unit 16 interacting with signal processing unit 18  generates control signals 19 which cause transmit pulsers 22  to generate driving signals for transducer elements in trans   ducer assembly 20  The driving signals are delivered to trans   ducer assembly 20 b
12. 0017  FIGS  2A  2B and 2C illustrate an ultrasound imag   ing device according to an example embodiment of the inven   tion equipped with different transducer assemblies for use in  different operational modes  In FIG  2A the transducer  assembly has elements arranged in a convex array  In FIG 2B  the transducer assembly has elements arranged in a linear  array  In FIG  2C the transducer assembly has elements  arranged to provide a phased array     0018  FIG  3 is a flow chart illustrating a method for ini   tializing an imaging device according to an embodiment of  the invention     US 2012 0232380 Al     0019  FIG 4isamore detailed view illustrating features of  a processor unit and a signal processing unit in an example  embodiment     0020  FIG  5A is a block diagram illustrating an ultra   sound imaging device configured for line placement and FIG   5B is an example of an image that could be generated by the  ultrasound imaging device of FIG  5A     0021  FIG  6A is a block diagram ofan ultrasound imaging  device configured for monitoring labour and delivery in  obstetrics applications and FIG  6B is an example ofan image  of the type that could be produced by the ultrasound imaging  device of FIG  6A     DESCRIPTION     0022  Throughout the following description specific  details are set forth in order to provide a more thorough  understanding to persons skilled in the art  However  well  known elements may not have been shown or described in  detail to avoid unnecessar
13. 0046  Insome embodiments the signals passed to proces   sor unit 16 by signal processing unit 18  on data path 30   comprise RF data  e g  data provided at a rate that is two or  more times the frequency of the ultrasound emitted by trans   ducer assembly 20   In such embodiments  processor unit 16  performs further processing to derive image data from the RF  data  By way of non limiting example  processor unit 16 may  perform functions such as  frequency analysis of the received  signals  by way of a fast Fourier transform  FFT  algorithm   for example   auto correlation  and the like in addition to or as  part of obtaining the image data     0047  In modes which involve Doppler imaging  signal  processing unit 18 may be configured to perform digital wall  filtering and or auto correlation     0048  As is apparent from the above  some functions that  are required in the signal path for certain operational modes  may be performed either by processor unit 16 or by signal  processing unit 18  In some cases  performance may be  increased by performing functions such as filtering  envelope  detection  log compression  auto correlation in processor unit  16  This may permit additional functions to be provided in  signal processing unit 18 in those cases where the capacity of  signal processing unit 18 is limited     0049  In some embodiments  signal processing unit 18 is  configured to perform beamforming on at least the signals  received from transducer assembly 20  In some embo
14. ARRAYS  application No  60 955 325   and    0029  WIRELESS NETWORK HAVING PORTABLE  ULTRASOUND DEVICES  application No  60 955   331    all of which are hereby incorporated herein by reference  The  features of the invention described herein may also be com   bined in any suitable combinations with the features  described in the commonly owned US non provisional  patent applications which are filed on the same day as the  instant application and entitled     0030  HAND HELD ULTRASOUND SYSTEM HAV   ING STERILE ENCLOSURE  claiming priority from  application No  60 955 327      Sep  13  2012     0031  HAND HELD ULTRASOUND IMAGING  DEVICE HAVING RECONFIGURABLE USER  INTERFACE  claiming priority from application No   60 955 328      0032  POWER MANAGEMENT IN PORTABLE  ULTRASOUND DEVICES  claiming priority from  application No  60 955 329      0033  HAND HELD ULTRASOUND IMAGING  DEVICE HAVING REMOVABLE TRANSDUCER  ARRAYS  claiming priority from application No   60 955 325   and     0034  WIRELESS NETWORK HAVING PORTABLE  ULTRASOUND DEVICES  claiming priority from  application No  60 955 331    all of which are hereby incorporated herein by reference    0035  FIG  1 shows an ultrasound imaging device 10  according to an example embodiment of the invention   Device 10 has a housing 12 containing electronic circuitry  which controls transducer elements in a transducer assembly  20 to transmit ultrasound signals into a subject  The electronic  circuitry also receives ultrasound signals
15. ORY and  EMBEDDED OS    PREPROCESSING and  DIGITAL BEAMFORMER FPGA    RECEIVE VCAs and A Ds  19  22   TRANSMIT PULSERS    20 TRANSDUCER    FIG  1       Patent Application Publication Sep  13 2012 Sheet 2 of 8 US 2012 0232380 A1    10 12  ia    34    20          FIG 2A    Patent Application Publication Sep  13 2012 Sheet 3 of 8 US 2012 0232380 A1    10       34    20A    FIG 2B    Patent Application Publication Sep  13 2012 Sheet 4 of 8 US 2012 0232380 A1    ee    14    34    20B    FIG 2C    Patent Application Publication Sep  13 2012 Sheet 5 of 8 US 2012 0232380 A1  J 40    42    TURN ON  BOOT OS and EMBEDDED  SOFTWARE  RECOGNIZE PLUGGED IN  ARRAY  READ CONFIGURATION  DATA FOR THE ARRAY    LOAD PREPROCESSING AND 50  BEAMFORMING FPGA WITH          44        46    48    THE CONFIGURATION DATA    READY TO IMAGE    FIG 3       Patent Application Publication Sep  13 2012 Sheet 6 of 8 US 2012 0232380 A1       PROCESSOR    PATIENT DATA    TX BEAMFORMER  PROGRAMMABLE    PROCESSING UNIT    RX BEAMFORMER       18    FIG 4    Patent Application Publication Sep  13 2012 Sheet 7 of 8 US 2012 0232380 A1    DISPLAY  S    LINE PLACEMENT  SOFTWARE 16A    LINE PLACEMENT IMAGING  SFOUFNCE AND GUIDE 18A    24 66B aS  RECEIVE VCAs and A Ds  22   TRANSMIT    o pases 7  FIG 5A       FIG 5B    Patent Application Publication Sep  13 2012 Sheet 8 of 8 US 2012 0232380 A1    DISPLAY 10  S  LABOR AND DELIVERY  SOFTWARE 16B    LABOR AND DELIVERY  SFOUFNCE AND PRFESFT 18B    24  RECEIVE VCAs and A Ds  22 
16. US 20120232380A1  as  United States    a2  Patent Application Publication  o  Pub  No   US 2012 0232380 A1       Pelissier et al   43  Pub  Date  Sep  13  2012   54  HANDHELD ULTRASOUND IMAGING  60  Provisional application No  60 977 353  filed on Oct   SYSTEMS 3  2007    75  Inventors  Laurent Pelissier  North Vancouver Publication Classification   CA   Kris Dickie  Vancouver  51  Int  Cl   ae ae Chan  AGIB 8 14  2006 01   ancouygi tes  62  U S  Ch en ee ee 600 424  CORPORATION  Richmond  CA   A handheld ultrasound device is provided  having a trans    21  Appl  No   13 476 142 ducer assembly for emitting and receiving sonic signals  a  configurable signal processing unit  and a data processor   22  Filed  May 21  2012 configured to provide configuration data to the signal pro      9    cessing unit  The configuration data defines a beamforming   configuration  filtering configuration and envelope detection   configuration for an operational mode  The operational mode    63  Continuation of application No  12 188 122  filed on may be selected by the user or may be determined based on a  Aug  7  2008  detected type of the transducer assembly     Related U S  Application Data    sa    12  14  PROCESSOR  MEMORY and  EMBEDDED OS 16    PREPROCESSING and  DIGITAL BEAMFORMER FPGA i 18    29    RECEIVE VCAs and A Ds    19    22 i TRANSMIT PULSERS  20 TRANSDUCER       Patent Application Publication Sep  13 2012 Sheet 1 of 8 US 2012 0232380 A1    14    12  DISPLAY I Os  PROCESSOR  MEM
17. d system is locked ina selected  one of the plurality of operational modes    18  The hand holdable ultrasound system according to  claim 1 wherein the processor unit is configured to synchro   nize the transmission and reception of ultrasound signals by  the transducer assembly by generating synchronization sig   nals and providing the synchronization signals to the signal  processing unit    19  The hand holdable ultrasound system according to  claim 1 wherein the configuration data associated with each  of the plurality of operational modes comprises information  specifying  transmit beamforming parameters  receive beam   forming parameters  filtering parameters  and envelope  detection parameters    20  The hand holdable ultrasound system according to  claim 1 wherein the plurality of operational modes includes a  user defined operational mode and the user interface controls  comprise user controls configured to permit a user to define  features of the user defined operational mode     x x x x x    
18. di   ments  in addition to beamforming  signal processing unit 18  performs filtering and or envelope detection on the signals  received from transducer assembly 20     0050  In those embodiments where signal processing unit  18 performs filtering of the signals received from transducer  assembly 20  signal processing unit 18 may be configurable to  implement digital filters having different filter coefficients for  different applications  The filter coefficients may be selected  to provide a good signal to noise ratio for each specific appli   cation  e g  each specific operational mode   For example  the  filter coefficients may be selected to pass signals having fre   quencies in a band around a frequency at which elements of  transducer assembly 20 are driven to emit ultrasound  Recon   figuring signal processing unit 18 may comprise program   ming interconnects  e g  signal connections  within a section  of a field programmable gate array  FPGA  that implements  one or more digital filters for the received signals     0051  In those embodiments where signal processing unit  18 performs envelope detection on the signals received from  transducer assembly 20  signal processing unit 18 may be  configurable to select from among a plurality of different  envelope detection algorithms  Reconfiguring signal process   ing unit 18 may comprise programming interconnects  e g   signal connections  within a section of an FPGA that imple   ments one or more envelope detectors that ac
19. er assembly     0066  Inother embodiments  a device 10 may be switched  between operational modes by means ofa control provided on  a user interface  In still other embodiments  device 10 is  intended to offer a single specific operational mode  Device  10 may be upgraded to provide enhanced features or to work  according to some different operational mode by uploading  new configuration data to device 10 by way of input output  interface s  32  In some embodiments  device 10 stores con   figuration data on a removable medium such as a card  chip   memory stick  memory or the like  In such embodiments it  may be possible to upgrade an existing operational mode or  add or change to a new operational mode by replacing the  removable medium with a removable medium that has con   figuration data for the new or upgraded operational mode  In  some embodiments  device 10 may have configuration data  for a number of different operational modes but some of the  operational modes may be locked out until a password  digital  key  or other authorization code is provided to release the  functionality of some of the operational modes     0067  FIG  3 shows a method 40 that may be implemented  when a device 10 as described above is turned on  In block 42    Sep  13  2012    the device is turned on  In block 44  device 10 initializes itself  by starting to run its operating system and then invoking  embedded software which coordinates the overall operation  of device 10  e g  on a processor 
20. he resulting image is displayed in real time on a  display  The classic presentation of the display  called  B mode  is a two dimensional image of a selected cross   section of the patient   s body  Modern ultrasound systems also  provide flow imaging modes such as Color Doppler and  Pulsed Doppler  which show and can help to quantify blood  flow     Sep  13  2012     0008  Recent miniaturization of electronics has enabled  the design of a generation of lighter  portable or handheld  ultrasound systems  Ultrasound systems described in the  patent literature include the following US patents     0009  U S  Pat  No  5 295 485 to Shinomura et al   describes a handheld ultrasound imaging system that  can be adapted to support multi element array transduc   ers and includes a beamformer     0010  U S  Pat  No  5 722 412 to Pflugrath et al   U S   Pat  No  5 817 024 to Ogle et al   and U S  Pat  No   6 203 498 to Bunce et al  describe handheld ultrasound  systems built around a set of ASIC  Application Specific  Integrated Circuit  chips  The systems include a trans   ducer array  an ASIC transmit receive front end  an  ASIC that includes digitization and digital beamforming  capabilities  an ASIC for signal processing and an ASIC  for display processing     0011  U S  Pat  Nos  6 251 073 and 6 569 102 to Imran  et al  describe a handheld ultrasound system that can  construct an image built from multiple transmit receive  acquisitions that are temporarily stored in a memory   The ha
21. ily obscuring the disclosure   Accordingly  the description and drawings are to be regarded  in an illustrative  rather than a restrictive  sense     0023  Anexample embodiment of the invention provides a  hand holdable ultrasound imaging device that can be config   ured to perform a range of specific ultrasound imaging pro   cedures  The device preferably has a form factor that permits  it to be carried in a shirt pocket  The device may provide a  simplified user interface for each operational mode so that it  can be used by personnel who may not have extensive training  The different operational modes may be selected for use in  different point of care settings  where a practitioner is inter   ested in looking inside patients    bodies for gathering anatomy  information  monitoring vital functions  targeting a particular  body structure  observing organ configurations  looking at  fetal positions or the like     0024  The features of the invention described herein may  be combined in any suitable combinations with the features  described in the commonly owned US provisional patent  applications entitled     0025  HAND HELD ULTRASOUND SYSTEM HAV   ING STERILE ENCLOSURE  application No  60 955   327      0026  HAND HELD ULTRASOUND IMAGING  DEVICE HAVING RECONFIGURABLE USER  INTERFACE  application No  60 955 328      0027  POWER MANAGEMENT IN PORTABLE  ULTRASOUND DEVICES  application No  60 955   329      0028  HAND HELD ULTRASOUND IMAGING  DEVICE HAVING REMOVABLE TRANSDUCER  
22. irst transducer assembly comprising a  convex array of transducer elements  a second transducer  assembly comprising a linear array of transducer elements  and a third transducer assembly comprising a phased array of  transducer elements    5  The hand holdable ultrasound system according to claim  1 comprising one or more input output interfaces for receiv   ing the configuration data into the hand holdable ultrasound  system wherein the one or more input output interfaces com   prise at least one of  an interface to a removable memory  medium  a wireless communication interface  a serial data  interface  a parallel data interface  and a universal serial bus  interface    6  The hand holdable ultrasound system according to claim  1 wherein the memory comprises a removable memory  medium and the configuration data is stored on the removable  memory medium    7  The hand holdable ultrasound system according to claim  1 wherein  for each of the plurality of operational modes the  one or more user interface controls comprise a user interface  control configured for providing a help request to the hand   holdable ultrasound system and wherein the processor unit is  configured to respond to the help request in a manner which is  specific to a current one of the plurality of operational modes    8  The hand holdable ultrasound system according to claim  1 wherein the display comprises one or more touch sensitive  user interface controls for providing user input to the hand   holdab
23. it   able transmitted ultrasound signals and processing received  ultrasound signals in such a manner as to produce an image  appropriate for the current operational mode     0074  Inthe embodiment illustrated in FIG  4  signal pro   cessing unit 18 is configured by configuration data delivered  by way of data path 28 to provide a transmit beamformer 60  and a receive beamformer 62  Depending upon the opera   tional mode  transmit beamformer 60 and receive beam     US 2012 0232380 Al    former 62 may comprise different numbers of channels and  may be configured in different ways to provide different  characteristics of the transmitted ultrasound signal as well as  to derive different information from received ultrasound sig   nals     0075  Processor unit 16 may be configured to synchronize  the transmission and reception of ultrasound signals by trans   ducer assembly 20  In such embodiments  synchronization  signals may be provided by way of data path 28     0076  When a received ultrasound signal is passed to sig   nal processing unit 18  the received signal is processed by  way of receive beamformer 62 and the resulting data is passed  to processor unit 16 by way of data connection 30  Processor  55 processes the data that it receives in a manner specified by  the configuration data 58B associated with the current opera   tional mode and displays the resulting data on display 14 in  the form of a suitable display  Processor 55 may optionally  also store the image data in 
24. le ultrasound system and the processor unit is config   ured to add  remove  reposition and reconfigure the user inter   face controls on the display under software control on  switching among the operational modes    9  The hand holdable ultrasound system according to claim  1 wherein  for at least a first one of the plurality of operational  modes  the processor unit is configured to provide configura   tion data to the signal processing unit to configure the signal  processing unit to provide different signal processing opera   tions for different lines of an ultrasound image    10  The hand holdable ultrasound system according to  claim 9 wherein for the first one of the operational modes  configuration data for all lines of an ultrasound image is  stored in the memory and the signal processing unit is con   figured to retrieve the configuration data for the lines of the  ultrasound image on an as needed basis    11  The hand holdable ultrasound system according to  claim 10 wherein the set of configuration data for the first one  of the operational modes is configured to configure the signal    Sep  13  2012    processing unit to provide a buffer that holds configuration  data for a current ultrasound image line wherein the buffer  also has space to hold configuration data for one or more  subsequent ultrasound image lines    12  The hand holdable ultrasound system according to  claim 11 wherein the set of configuration data for the first one  of the operational modes is
25. memory 57 and or transmit the  image data to a network or other device by way of input   output interface s  32     0077  In some embodiments  signal processing unit 18  comprises a field programmable gate array  FPGA  that is  connected to amemory 57 by a bus 59  Memory 57 may store  configuration data 58B  Such configuration data 58B may  comprise configuration data associated with one or more  operational modes  By way of non limiting example  the  configuration data associated with each operational mode  may comprise information specifying one or more of      0078  transmit beamforming parameters    0079  receive beamforming parameters    0080  filtering parameters     0081  envelope detection parameters    0082  etc     All configuration data 58B may be stored in memory 57   Memory 57 may  for example  comprise a flash memory or  the like  Providing a single memory 57 that contains all con   figuration data 58B simplifies construction and potentially  reduces power consumption  Processor unit 16 may control   directly or indirectly  what portion of configuration data 58B  is loaded from memory 57 into signal processing unit 18  The  portion of configuration data 58B loaded into signal process   ing unit 18 may be associated with a particular operational  mode     0083  Some embodiments provide the option of configur   ing signal processing unit 18 differently for each line of an  ultrasound image  In some such embodiments  configuration  data for all lines of the ultraso
26. ndheld system has the ability to output a diagnos   tic image built from multiple transmit receive acquisi   tions     0012  U S  Pat  Nos  5 590 658  6 106 472  and 6 638   226 to Chiang et al  describe a handheld ultrasound  system that includes a transducer coupled to a CCD   based analog beamformer and post processing electron   ics  The system uses a separate back end to further pro   cess and display diagnostic images     0013  U S  Pat  No  7 115 093 to Halmann et al   describes a handheld ultrasound imaging system com   prising a detachable scanhead coupled to a traditional  beamforming module  that is connected via a USB  Uni   versal Serial Bus  port to a commercially available PDA   Portable Digital Assistant   The PDA performs post  processing functions to yield ultrasound images     0014  Theinventors have recognized a need for a handheld  ultrasound imaging device that is cost effective and can be  configured to operate in multiple different modes to address  different application specific needs     BRIEF DESCRIPTION OF THE DRAWINGS     0015  Non limiting example embodiments are illustrated  in the accompanying drawings  The embodiments and figures  disclosed herein are examples that illustrate ways in which  the invention may be implemented  The invention is not lim   ited to the illustrated embodiments     0016  FIG  1 is a block diagram illustrating major func   tional components of a ultrasound imaging device according  to an embodiment of the invention     
27. of processor unit 16   In  block 46  the type of transducer assembly 20 that is connected  to device 10 is determined  either by detecting information  identifying the transducer assembly 20 or in some embodi   ments by receiving user input      0068  In block 48  the configuration data for the opera   tional mode corresponding to the transducer assembly 20  recognized in block 46 is read and  in the illustrated embodi   ment  signal processing unit 18 is configured according to the  configuration data in block 50  The configuration data may  additionally specify software to be run on processor unit 16 to  support imaging in the corresponding operational mode  In  block 50  the transmit and receive circuitry  i e  transmit  pulsers 22 and receive signal processing stage 24  may be  shut down and placed in a standby mode waiting for instruc   tions to commence imaging     0069  Although not specifically shown in FIG  3  user  interface controls and or user manual information associated  with the operational mode may also be loaded by processor  unit 16 as a part of method 40 or otherwise     0070  Imaging may commence automatically upon device  10 detecting that transducer assembly 20 is in contact with a  subject or  in the alternative  may be invoked by means of a  suitable user interface control     0071  FIG  4 shows  in more detail  processor unit 16 and  signal processing unit 18 according to a particular embodi   ment  Processor unit 16 comprises one or more suitable da
28. r transducer assem   blies  the transducer assembly suitable for ultrasound  imaging in a corresponding one of a plurality of opera   tional modes of the ultrasound system    a driving circuit operable to deliver driving signals to excite  the transducer elements of the transducer assembly to  emit ultrasound signals  the driving circuit comprising a  plurality of transmit pulsers    a receive circuit operable to receive reflected ultrasound  signals detected at the transducer assembly and to con   dition the received reflected ultrasound signals to yield  conditioned signals  the receive circuit comprising one  or more analog to digital converters arranged to digitize  the received reflected ultrasound signals    a configurable signal processing unit connected to receive  the digitized conditioned signals and to process the con   ditioned signals  the configurable signal processing unit  comprising a field programmable gate array    a processor unit comprising one or more data processors  and a memory  the memory storing software instructions  for execution by the one or more processors and a plu   rality of sets of configuration data  each of the plurality  of sets of configuration data corresponding to a corre   sponding one of the operational modes of the plurality of  operational modes    adisplay operable to display an image based at least in part  on the reflected ultrasound signals detected at the trans   ducer assembly  and   one or more user interface controls for p
29. roviding user input  to the hand holdable ultrasound system    wherein the software instructions are configured to cause  the one or more data processors to   identify a type of the transducer assembly   based on the identified type of the transducer assembly    select one of the plurality of operational modes cor    responding to the transducer assembly for which the   ultrasound system should be configured  and  configure each of  the signal processing unit  the trans    mit circuit  the processor and the user interface con    trols according to one of the sets of configuration data   corresponding to the selected operational mode    wherein    the sets of configuration data for different ones of the   plurality of operational modes are configured to config     Sep  13  2012    ure the signal processing unit to implement digital filters  having different filter coefficients to provide filtering of  the conditioned reflected ultrasound signals received  from the transducer assembly     the set of configuration data for at least one of the opera   tional modes is configured to configure the field pro   grammable gate array to both generate control signals  for the transmit circuit and to provide processing of  detected signals received from elements of the trans   ducer assembly     the set of configuration data for at least one of the opera   tional modes is configured to specify software to be run  on the processor unit to support imaging in the corre   sponding operational
30. t on the received  signals     Sep  13  2012     0052  Input output interface s  32 may be provided to  place ultrasound device 10 in data communication with one or  more other devices  Input output interface s  32 may com   prise one or more wireless interfaces  which may  for  example  comprise RF wireless interfaces  infrared wireless  interfaces or the like  or other connections such as serial  connections  USB connections  parallel connections  or the  like  In some embodiments  device 10 has wireless connec   tivity according to the Bluetooth    standard or an IEEE 802   11 standard  otherwise known as WIFI       0053  FIG  2A shows a handheld ultrasound imaging  device 10 according to an example embodiment of the inven   tion  Device 10 has a housing 12 which is suitably small  enough to be hand carried  and preferably is small enough to  keep in a person   s pocket  For example  housing 12 may have  dimensions of approximately 10 cmx8 cmx2 cm  and device  10 may weigh less than 10 pounds  i e  4 5 kg   A display 14  is provided on housing 12 as are one or more user interface  controls 34  Control 34 may  for example  comprise an on off  switch for the purpose of turning device 10 on and shutting  device 10 off      0054  In some embodiments  display 14 comprises a  touch sensitive display and controls for operating device 10  may be provided in the form of touch sensitive areas on  display 14 and or by way of the capability of device 10 to  recognize gestures or other
31. ta  processor s  55   a single data processor 55 is shown in the  illustrated embodiment  Data processor 55 may  for example   comprise a suitable microprocessor  digital signal processor   DSP   image processor  or the like  In an example embodi   ment  data processor 55 comprises a BlackFin    digital sig   nal processor available from Analog Devices  Inc  of Nor   wood Mass     0072  Processor 55 is capable of executing software  instructions which may be stored in memory 57 accessible to  processor 55 or which may be otherwise accessible to pro   cessor 55  In the illustrated embodiment  memory 57 contains  an operating system 58A and configuration data 58B for one  or more operational modes  Memory 57 may also have capac   ity to store patient data 58C  e g  images  information identi   fying patients  or the like      0073  Processor 55 can cause configuration data  e g  for a  particular operational mode and or for a particular type of  transducer array 20  to be delivered to signal processing unit  18 by data path 28 or directly from a memory 57 to signal  processing unit 18 by way of a suitable bus  e g  bus 59   connected to deliver the configuration data from memory 57  to signal processing unit 18  Such configuration data may  comprise all or a part of configuration data 58B stored in  memory 57  The configuration data may cause suitable inter   connects  e g  signal processing paths  to be created within  signal processing unit 18 for the purpose of generating su
32. und image may be stored in  memory 57 and retrieved by way of bus 59  or data connec   tion 28  on an as needed basis  For example  signal process   ing unit 18 may comprise a buffer that holds configuration  data for a current ultrasound image line and also has space to  receive configuration data for one or more subsequent ultra   sound image lines  The configuration data for the subsequent  ultrasound image lines may be read into the buffer from  memory 57 while the current ultrasound image line is being  processed according to configuration data in the buffer  To  facilitate such operation  the buffer may be set up as a circular  buffer or    ping pong    buffer  for example     0084  Some or all of the configuration data 58B stored in  memory 57 may be generated by processor 55 executing  suitable software instructions  For example  processor 55  may execute software for calculating filtering coefficients  and or beamforming coefficients for a particular operational  mode  User controls may be provided so that a user can define    Sep  13  2012    features of the operational mode  The resulting coefficients  may then be saved into memory 57 so that they are available  to be loaded for configuration of signal processing unit 18  when the user defined operational mode is invoked     0085  FIG  5A shows an example of a device 10 which has  been configured to provide a line placement operational mode  and FIG  5B shows an example of a resulting image 66 when  device 10 is so
33. ware platform  to provide a range of specialized operational modes permits  volume manufacture of the platform even in cases where  some of the individual operational modes may be very spe   cialized and in relatively low demand  Furthermore  the abil   ity to specialize the device under software control by adding  and or removing and or repositioning and or reconfiguring  user interface controls on display 14 and or by changing  functions assigned to any interface controls not provided by    US 2012 0232380 Al    display 14 permits the device 10 to offer a simplified and  highly effective user interface in each of its available special   ized operational modes     0061  In some embodiments  a device 10 can be locked in  a selected operational mode  Such a device may be sold at a  relatively low cost without disrupting the market for devices  10 configured to perform in other operational modes     0062  The user interface may be provided as described in  co pending U S  Patent Application No  60 955 328 entitled  Hand held Ultrasound Imaging Device Having Reconfig   urable User Interface  filed on 10 Aug  2007  or its counter   part US non provisional application of the same title  filed on  the same date as the instant application  both of which are  hereby incorporated herein by reference     0063  In some cases for different operational modes it is  desirable to provide different arrangements of transducer ele   ments in transducer assembly 20  For this purpose  device 10 
34. y way of interface 26  The timing  phases   intensities and or other characteristics of the driving signals  may be set to provide ultrasonic signals appropriate to the  current operational mode  For example  the timing  phases   intensities and or other characteristics of the driving signals  delivered to transducer assembly 20 may be controlled by  signal processing unit 18  using control signals 19  which  may in turn be configured for the current operational mode by  processing unit 16  using appropriate control signals on data  path 28      0044  Transducer assembly 20 has elements which pick up  reflected ultrasound signals  These reflected signals are  passed through interface 26 to receive signal conditioning  stage 24  Signal conditioning stage 24 may include filters     US 2012 0232380 Al    voltage controlled amplifiers  and the like to condition incom   ing signals  Signal conditioning stage 24 also includes one or  more analog to digital converters which digitize the signals  picked up by elements of transducer assembly 20 and pass the  digitized signals 29 to signal processing unit 18     0045  Within signal processing unit 18  signals 29 are  entirely or partially processed and then passed on data con   nection 30 to processor unit 16 which displays the resulting  image on display 14 or  in the alternative  provides further  processing of the signals on data path 30  i e  from signal  processing unit 18  and then displays the resulting image on  display 14     
    
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