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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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