Protocol controller for a medical diagnostic imaging system
Contents
1. The processor 120 processes the sensed voltages to create an ultrasound image that is displayed on the display device 130 The ultrasound system 100 can be used to perform any number of exams or studies of a patient Some studies require a user to follow a defined protocol A protocol is a sequence of steps performed by a user e g a sonog rapher or physician to perform a particular ultrasound study A protocol is often used with a staged study although a protocol can also be used with a non staged study A staged study contains a set of images acquired under specified conditions during two or more time intervals called stages with a consistent set of images called views acquired during each stage of the study The protocol for a staged study dictates the actions a user must perform to complete the study A user proceeds through a staged protocol exam one stage at a time acquiring images with the capture settings of each stage One example of a staged study is a stress echo ultrasound study which allows a clinician to compare left ventricular motion from a variety of views with and without stressing the heart A typical stress echo protocol consists of the user imaging and capturing clips of the patient s heart while the patient s heart is at its resting heart rate The standard views of the heart that are imaged and captured are Parastemal Long Axis PLAX Parastemal Short Axis PSAX Apical Four2. addition to the SE Protocol Controller The Contrast Protocol Controller is in the Normal Acquisition Sequence 1 state The system will flow through the SE protocol using the SE protocol defined parameter values and since Contrast was enabled by selecting the Contrast button the system will additionally flow through the Contrast protocol using its defined parameter values Since the parameter Duration per Clip is defined for both protocols the Contrast value of 2 heart beats will be used If Contrast was disabled then the Contrast Protocol Controller would not be active and its parameter values would not be used The Contrast protocol acquisition sequence will transmit using the defined parameters above Every N 1 N 0 initially heart beats the system will transmit a burst of 5 frames of high power followed by transmitting low power Each time the Clip Capture button is selected the system captures 4 clips Clips per Capture 4 where each clip is 2 heart beats long Lo ROI size Duration per Clip 2 heart beats Clip Capture Size 44 ROI for all Views View Sequence of the Baseline stage Following the capture of 4 clips for the last view A2C the system will transition from live imaging mode to review Clip Auto Review End of Stage of the clips that were captured Huo D User Input The user selects the clips he wants to keep the ones that captured the anatomy clearly As part of selecting t
3. Chamber A4C and Apical Two Chamber A2C Next the patient s heart rate is increased to its maximum either by exercise e g treadmill bicycle or with the use of drugs for those patients who are unable to exercise The user will image and capture clips standard views of the patient s heart while the patient s heart rate is at its maximum increase before the heart rate slows down images are typically captured within 60 90 seconds after exercise has stopped The user reviews the captured clips and selects the clips he wants to keep The rest of the clips are deleted when the study has ended The standard has been to capture at least four clips of each view and only keep the best clip for each view of each stage An ultrasound imaging system can assist a user in per forming a staged protocol study of a patient by automatically controlling various system parameters in accordance with the protocol to guide the user through a pre defined series of clip acquisitions For example an ultrasound system can be programmed with a series of preset defined protocols e g a two stage exercise stress echo protocol a four stage exer cise stress echo protocol etc that a user can select for a particular study Based on the selected protocol the ultra sound system automatically moves through stages and views moves between imaging and review of captured images provides automatic movement to the next stage and performs automatic storage
4. Review to view all clips captured for the exam The user selects the clips he wants to keep the ones that captured the anatomy clearly As part of selecting the clip the user will label the clip with the appropriate View label Oe PLAX etc US 6 953 433 B2 7 TABLE 4 continued System Response The Protocol Controller knows the View Sequence of this Pharmacologic Stress Echo exam The protocol will default the clip label to the next View label as the user assigns View labels to their selected clips System transitions from review to live imaging The SE Protocol Controller is in Imaging state Low Dose stage A2C view The Contrast protocol acquisition sequence will transmit using the defined parameters above Every N 1 N 0 initially heart beats the system will transmit a burst of 5 frames of high power followed by transmitting low power Each time the Clip Capture button is selected the system captures 4 clips Clips per Capture 4 where each clip is 2 heart beats long Lo ROI size Duration per Clip 2 heart beats Lo ROI size for all Views View Sequence of the Low Dose stage Following the capture of 4 clips for the last view PLAX the system will transition from live imaging mode to review Clip Auto Review End of Stage of the clips that were captured The Protocol Controller knows the View Sequence of this Pharmacologic Stress Echo exam The protocol will default the clip label to the next View
5. and retrieval of each view The ultrasound system would also know how to capture and US 6 953 433 B2 3 playback clips and can automate system actions where appropriate such as automatically performing a system transition to help eliminate the number of steps i e button hits the user must perform thereby reducing the user s workload While some existing ultrasound systems offer some degree of user customization of a protocol such as the number of stages the number of views and the clip capture parameters used for each stage view or remembering image parameter settings changed by the user in one stage and then recalling those settings in a subsequent stage the protocol in those systems is for the same application e g a stress echo protocol In one embodiment the concept of protocol is expanded beyond its use in stress echo More generally the processor 120 in the ultrasound system 100 can be configured to run a protocol controller 160 that allows two or more different protocols to be active simultaneously and be executed together in an integrated fashion By allowing multiple protocols to be active and work together imaging modes can be changed in a user customizable pre defined way as the protocol proceeds This allows the protocol to drive the basic imaging of the system For example an emerging application in ultrasound is the use of contrast agents during imaging This typically involves imaging the target organ bef
6. may also be invoked by another menu on the ultra sound system As an alternative to or in addition to the above cursor behavior a set of console buttons may be used to advance repeat and pause the sequence In addition to measurements the auto sequences may also include prompts for the user to adjust the transducer or make adjustments to the machine state or image settings etc As noted above each of the embodiments described herein can be used alone or in combination with one another As also noted above these embodiments can be used with image modalities other than ultrasound imaging and the claims should not be limited to any particular type of image modality unless explicitly recited therein Examples of dif ferent types of image modalities that can be used with these embodiments include but are not limited to computed tomography CT magnetic resonance imaging MRI computed radiography magnetic resonance angioscopy color flow Doppler cystoscopy diaphanography echocardiography fluoresosin angiography laparoscopy magnetic resonance angiography positron emission tomography single photon emission computed tomography X ray angiography computed tomography nuclear medicine biomagnetic imaging culposcopy duplex Doppler digital microscopy endoscopy fundoscopy laser surface scan magnetic resonance spectroscopy radio graphic imaging thermography and radio fluroscopy It is intended that the foregoing detailed d
7. protocol finite state machine is created and initialized The param eters define to the system how to perform or respond to certain user actions e g selections The protocol finite state machine always knows what state the protocol is in and defines the sequences of operations that occur in response to 15 20 25 30 35 40 45 50 55 60 65 external stimuli e g user actions such as button presses or selections The external stimuli user actions generates system events and the finite state machine s response to an event depends on the state of the finite state machine receiving the event It can include a change of state or the sending of another event The Protocol Controller 160 can have one or more protocol finite state machines created and running concurrently The protocol finite state machines can send events to each other so they can be synchronized FIGS 2 and 3 are stress echo and contrast state transition diagrams respectively In these figures the lines with arrows represent Events Events are labeled using Event in the name There are entry functions that get executed as the corresponding state is entered As events are received the finite state machine may change states Events can have guards or action functions These diagrams show guards and are functions that get called when transitioning to the state The guard function checks some conditions such as check ing a parameter for a
8. specific value The guard function must return true before the transition to that state will actually occur i e if the guard function does not return true then the new state is not entered Turning now to FIG 2 the stress echo protocol finite state machine 200 comprises three concurrent finite state machine SystemStates 210 Stages 220 and Views 230 The SystemStates finite state machine 210 comprises two states Imaging 212 and Review 214 The Imaging state 212 is when the system is in live image acquisition and the Review state 214 is when the system is in review of captured images still images or multi frame images clips The Stages finite state machine 220 has as many stages as the system allows In one embodiment a maximum of ten stages is used because most stress echo studies will use four to seven stages Of course fewer or more stages can be used These stages correspond with the user stages e g Stagel would be Baseline Stage2 would be Low Dose and Stage 3 would be Peak Dose When a Stage is entered the entry guard function displayStage Timer will display the Stage timer if the presets had set the parameter to tell the system to display it otherwise it will not be displayed When the SelectStag eEvent is received it has a parameter of Stage This tells the finite state machine to go to the Stage passed in For example SelectStageEvent Stage2 tells the finite state machine to go to Stage2 The user would ha
9. system Turning now to FIG 1 an ultrasound system 100 typically comprises a transducer probe 105 a beamformer 110 a processor 120 a display device 130 a storage device 140 and a user interface 150 The term processor is being used to broadly refer to the hardware components and or software compo nents i e computer readable program code of the ultra sound system 100 that are used to implement the function ality described herein Any suitable hardware software components can be used Further it should be noted that 10 15 20 25 30 35 40 45 50 55 60 65 2 multiple processors can be used and that the functionality described herein can be performed by a single processor or can be distributed among several processors Additionally some or all of the functionality described herein can be implemented purely with hardware During an ultrasound examination a sonographer con tacts the transducer probe 105 with a patient and the ultrasound system 100 generates an ultrasound image In general the ultrasound system s processor 120 causes the beamformer 110 to apply a voltage to the transducer 105 to cause it to vibrate and emit an ultrasonic beam into the portion of the patient s body in contact with the transducer 105 Ultrasonic energy reflected from the patient s body impinges on the transducer 105 and the resulting voltages created by the transducer 105 are received by the beam former 110
10. the use of a Contrast agent The use of the Contrast agent for MP myocardial perfusion is to identify perfusion efects from induced schemia The purpose is to ocument a change in the ontrast bubble delivery at est patient heart rate at est compared with stress patient heart rate at maximum increase The user plugs the appropriate cardiac ransducer into the system and selects the Pharmacologic Stress Echo exam BA a2 o o a The user images the patients heart and decides to capture a clip of the heart in BC mode before beginning the Stress Echo Contrast exam The user selects the Alternate Capture via a UI selection to active the Alternate Capture definitions The user changes the system from B mode to BC mode The user selects the Clip Capture button to start a Clip capture When finished the user selects the Clip Capture button to stop the Clip capture The user disables the Alternate Capture so they can start the SE Contrast exam The user enables Contrast by selecting the Contrast button and begins image acquisition The user injects the patient with the Contrast agent and invokes the Contrast acquisition sequence The user selects the Clip Capture button to capture clips for each of the 4 views PLAX PSAX A4C A2C for the Baseline stage a Stress Echo exam type exercise or pharmacologic This example assumes a Pharmacologic Stress Echo exam has
11. Clip 1 heart beat Clip Auto Review End of Stage Clip Capture Size 1 4 ROI R Wave Trigger On Clip Capture parameter values for Low Dose Stage View Sequence A2C A4C PSAX PLAX Clips per Capture 4 Clip Capture Method Prospective Compression Rate Medium Duration per Clip 1 heart beat Clip Auto Review End of Stage Clip Capture Size 1 4 ROI R Wave Trigger On Clip Capture parameter values for Peak Dose Stage View Sequence PLAX PSAX A4C A2C Clips per Capture Continuous Clip Capture Method Prospective Compression Rate Medium Duration per Clip 1 heart beat Clip Auto Review Off Clip Capture Size Lo ROI R Wave Trigger On Clip Capture parameter values for an Alternate Capture Definition Clips per Capture 1 Clip Capture Method Prospective Compression Rate Medium Duration per Clip 1 minute Clip Auto Review Off Clip Capture Size Lo ROI R Wave Trigger Off TABLE 3 Protocol Parameter Definition Values for Contrast Sequence for Myocardial Perfusion MP Protocol Trigger R wave Burst Duration 5 frames at high MI Transmit Duration Continuous except during Burst at low MI Transmit Transition Delay 0 Restart Sequence after N 1 where N r wave to r wave interval Duration per Clip 2 heart beats US 6 953 433 B2 TABLE 4 User Input User wants to perform a System Response The system provides the user with the capability to choose Stress Echo exam with
12. SSLAS DOT U S Patent US 6 953 433 B2 Sheet 3 of 3 Oct 11 2005 U S Patent Ce En el aouanbesjeadas Jeduanbasyopug OZE Saduanbasuonisinbayase uo5 basjewJoNojuinjes Jevenbesboysopug JuaAgU0RIsINbaygse13U0D aJe3Sbayasesnuojjas AnNua ajzeIsboyjewonjes Aguso uONISINbayaAse uO5 UONISINDay EW ON JUBAJUONISIN bDYJ BLWJON VIE Saje uonisinbay Ole WSIJSENUOD y Oog US 6 953 433 B2 1 PROTOCOL CONTROLLER FOR A MEDICAL DIAGNOSTIC IMAGING SYSTEM BACKGROUND The use of protocols to support a stress echo exam is now standard within the ultrasound industry The common prac tice is to step the user through pre defined series of clip acquisitions that allow the clinician to compare left ven tricular motion from a variety of views with and without stressing the heart Within the industry there are some very standard pre defined protocols e g two stage exercise stress four stage exercise stress etc The Sequoia Echocardiography Platform offers some degree of user cus tomization of protocol factors such as the number of stages the number of views and the clip capture parameters used for each stage view Additionally the Phillips 5500 system extends the protocol concept to imaging parameters in a limited way by providing the ability to remember image parameter settings changed by the user in one stage and then recall those settings in a subsequent stage SUMMARY The present in
13. a United States Patent Kerby et al US006953433B2 US 6 953 433 B2 Oct 11 2005 10 Patent No 45 Date of Patent 54 PROTOCOL CONTROLLER FOR A MEDICAL DIAGNOSTIC IMAGING SYSTEM 75 Inventors Cynthia L Kerby Carnation WA US Laurence S McCabe Sunnyvale CA US David R DeWitt Livermore CA US 73 Assignee Siemens Medical Solutions USA Inc Malvern PA US Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 U S C 154 b by 19 days 21 Appl No 10 651 374 22 Filed Aug 29 2003 65 Prior Publication Data US 2005 0049493 A1 Mar 3 2005 SA de nerede A61B 8 00 52 USS e sn sonnet noon ora E wensen 600 443 58 Field of Search 600 437 443 600 447 128 916 700 11 28 705 10 11 17 21 31 32 136 56 References Cited U S PATENT DOCUMENTS 5 831 612 A 11 1998 Stoval et al 715 792 6 139 498 A 10 2000 Katsman et al 600 443 6 275 869 B1 8 2001 Sieffert et al 719 321 6 397 098 BI 5 2002 Uber etal 600 431 6 458 081 B1 10 2002 Matsui et al 600 437 6 773 398 B2 8 2004 Ogasawara et al 600 437 6 786 869 B2 9 2004 Hashimoto 600 437 2002 0035326 Al 3 2002 Kamiyama 600 437 2003 0191389 Al 10 2003 Sano et al OTHER PUBLICATIONS we 600 437 Acuson Sequoia 512 Ultrasound System User M
14. acros A new protocol can be created by combining 10 15 20 25 30 35 40 45 50 55 60 65 12 a unique set of macros from this pool of already defined macros The Protocol Controller 160 itself can then be implemented as an engine used to drive a series of macros This development is particularly useful in that the engine ie the Protocol Controller 160 can run multiple protocols concurrently and or one protocol can be suspended its exit point marked then another protocol activated and later return to the exit point of the original protocol and continue with the first protocol This is illustrated in the above example showing the concurrent use of pharmacologic stress echo and contrast protocols Instead of being a set of parameters a macro can be a code snippet That is a macro can be any sequence of instructions that can be interpreted by another process causing that process to execute a sequence of instructions In this sense a macro is any sequence of instructions that can be interpreted by another process causing that process to execute or have executed a sequence of instructions For example a protocol can have a data or image capture segment Each instantiation of capture can be built as a macro such as store image to disk or store clip to VCR Of particular usefulness might be an instantiation of a macro for storing data utilizing parameters for a data type and device type Sto
15. active a DICOM device a CD a DVD a VCR an MO drive a printer and a networked device Suitable protocol macros include a clip capture macro a clip playback macro a workflow macro and an acquisition sequence macro The following are examples of these types of macros Clip Capture Number of clips to capture per clip capture activation 1 2 4 etc Duration length of each clip to be captured in seconds microseconds heartbeats etc R wave trigger clip capture enabled disabled capture clips based on patients heartbeat or not Clip capture delay time a delay time after an r wave trigger occurs to start capturing the clip in microseconds US 6 953 433 B2 13 Clip compression level Clip capture size full screen quarter screen or some other derivative size Clip Playback Clip playback speed Clip playback mode align heartbeats of multiple captured clips or just play each clip or start each clip together at the same time Workflow Enable disable to automatically delete unselected clips at end of exam Enable disable to automatically move the system to the next stage of a staged protocol Enable disable to automatically start and stop VCR recording based upon some defined event Enable disable to automatically save and recall imaging parameters a defined set such as transmit receive settings imaging mode filters and processing settings etc upon some defined event such as the first view of eac
16. and settings receive parameters and settings imaging mode imaging parameters and settings filters and processing specifics signal processing options post processing options frequency harmonic mode pulse rep etition frequency and frame rate 12 The invention of claim 9 wherein at least one of the macros controls one or more of the following display control number of views annotation a user interface page displayed in the display area an active tool displayed in the display area a cursor in the display area and a number of views in the display area 13 The invention of claim 9 wherein at least one of the macro control one or more of the following system control measurements and reports annotations pictograms review and display features user preferences which user interface page is displayed and which tool cursor is active 14 The invention of claim 9 wherein at least one of the macros controls one or more of the following a DICOM device a CD a DVD a VCR an MO drive a printer and a networked device
17. anual cover page pp ii 184 and 186 189 Apr 1999 Acuson Sequoia 512 Ultrasound System Administrator Megas GP Advanced Applications Image Management System I M S http www esaote com products ultra sound megas cAdvAppliclmsGP htm 1 page printed Oct 29 2002 Ultrasound Vivid FiVe GE Medical Systems http ww w gemedicalsystems com rad us products vivid 5 msuvivid5 html 2 pages printed Oct 29 2002 HP Introduced Advanced Diagnostics for HP SONOS 5500 Echocardiography Ultrasound System http pacificwest medical com hewlett packard htm 5 pages printed Oct 29 2002 Sonos 5500 Ultraperformance Upgrade Philips Medical Systems http www medical philips com main products ultrasound cardiology sonos5500 upgrades 2 pages printed Jul 30 2003 Sonos 5500 Philips Medical Systems http www medi cal philips com main products ultrasound cardiology sonos5500 1 page printed Jul 30 2003 Sonos 5500 Features and Benefits Philips Medical Sys tems http www medical philips com main products ultra sound cardiology sonos5500 features 1 page printed Jul 30 2003 Annex X Ultrasound Staged Protocol Data Management 3 pages undated cited by examiner Primary Examiner Francis J Jaworski 57 ABSTRACT The embodiments described herein relate to a protocol controller for a medical diagnostic imaging system In one embodiment two or more
18. been chosen The system performs system initialization for the Stress Echo exam This entails initializing parameter values for the selected transducer and the Stress Echo exam such as imaging parameters calculation package s and the Stress Echo protocol Additionally it initializes the Contrast protocol so that a Contrast protocol can be used during a Stress Echo SE exam The SE Protocol Controller is the current active protocol in the Imaging state Baseline stage PLAX view The system changes the Protocol Clip Capture definitions from the Pharmacologic Stress Echo Protocol Clip Capture definitions to the Pharmacologic Stress Echo Protocol Alternate Capture Clip Capture definitions These Alternate Capture definitions allow the user to temporarily capture clips in a non SE capture method without leaving the SE exam or having to change any Protocol definitions When the Clip Capture button is selected the system captures 1 Clip Clips per Capture 1 where the Clip is up to 1 minute long The Clip size is full screen Clip Capture Size Full Screen The system will NOT transition from live imaging mode to review Clip Auto Review Off of the clip just captured The system changes the Protocol Clip Capture definitions from the Pharmacologic Stress Echo Protocol Alternate pture Clip Capture definitions to the Pharmacologic ress Echo Protocol Clip Capture definitions he Contrast Protocol Controller becomes active in
19. distinct study protocols are active on a medical diagnostic imaging system at the same time In another embodiment control of a medical diagnostic imag ing system is changed at each stage of a study protocol sequence to optimize study performance In yet another embodiment a protocol is created from a collection of macros that control a medical diagnostic imaging system Other embodiments are provided and each of the embodi ments described herein can be used alone or in combination with one another 14 Claims 3 Drawing Sheets 100 Storage Device US 6 953 433 B2 Sheet 1 of 3 Oct 11 2005 U S Patent Qe AUT Jes Jajjo juoj j090 01d aJIA3A abeo15 02 JOSS9J0Jd aJIAJA Ae dsig Jouojweag OO matA se uo pue abe 5e UO pue O20JOLdJOPUIMIAS OET JO MalAJSEJUO PUR BGLISJOPUIMIIAJ JO ainjderjQopuyMalaas JDuaAJgauMdejjsoPpuI US 6 953 433 B2 vorsenuogst Juonisinbayase nuojop Anua SMalA Ze 5 Z7 matasyo ndepjopugou JiusAga mdejopua Ma JiusA MalAPD3 a5 a E vo4ejdsig w Lafe si LautabecApicdemp JA mua a ov z sabes W a ugpaBeysyxanonys abeys Jjuaazabeyspajas pue malaayabe1SJOPUJON Yi pue MalAayeimdeDJOPUZOU JjuaAJaunideJ JOopug gt gt ai jusAJEANNDIVISL1IJUOJ y JuaA36uIbeWT 5 MalAay ANua BuiBewy Anua z JUBAQMBIASY Malady Gulbewr JuaAgmalaay ZIT a SaJeISWaIs S JueAgaInbayjsenuogdors OLT WS4OyPA
20. e order of measurements and by adding or removing measurements The setup facilities provide for any number of sequences to be stored in memory each with a specifie name that is displayed on the sequence selection menu The user may also designate a particular subset of the sequences to be displayed on the menu along with the order in which they appear While a sequence is active the icon displays the name of the current measurement When the cursor is moved over the icon a tool tip appears that displays the name of the next measurement in the sequence and the cursor is changed to the shape of a hand with the index finger pointing to the right This represents skipping directly to the next measure ment in the sequence if the cursor is clicked If the cursor is instead moved to the left the cursor changes to a hand with the index finger pointing to the left indicating a repeat of the previous measurement and the tool tip text changes to the name of the previous measurement A double click on the icon at any point pauses the sequence During a pause the user may take any actions or measurements desired The sequence is resume by double clicking on the icon The icon will change in a recognizable way to indicate that the sequence is paused e g change color A dedicated key on the ultrasound console may be used to invoke the auto sequence icon In this case pressing the key during a sequence will terminate the sequence The sequence menu
21. enu provides a free style mea surement selection and execution that requires the user to revisit the menu for each successive measurement However for the majority of exams a standard set of measurements are routinely performed in a standard sequence There may be several such sets of measurements at any specific site or clinic In this embodiment an ultra sound system provides an icon that represents an automated sequence of exam measurement The icon and associated keys provide user control of the sequence including pause repeat and skip capabilities The icon displays the name of the currently active measurement and a tool tip that displays the next measurement in the sequence Upon invocation a menu is displayed that allows the user to select a particular sequence e g a uterus or abdominal 10 15 20 25 30 35 40 45 50 55 60 65 14 sequence When a sequence is selected from the menu the first measurement of the sequence is started i e the system enters the proper measurement state and the appropriate measurement tool s are displayed The user then performs the measurement Once the measurement is completed and its value committed the next measurement in the sequence begins A sequence may be terminated by completing the sequence or by repeating the action that invoked the sequence e g pressing the auto sequence key Setup facilities allow the user to customize the sequences by changing th
22. escription be understood as an illustration of selected forms that the invention can take and not as a definition of the invention It is only the following claims including all equivalents that are intended to define the scope of this invention US 6 953 433 B2 15 What is claimed is 1 A medical diagnostic imaging system comprising a storage device storing a plurality of study protocols for directing an operation of the medical diagnostic imag ing system during a medical examination each study protocol comprising a respective sequence of steps performed by a user to perform a particular study and a processor operative to have at least two distinct study protocols active at the same time wherein the processor is further operative to suspend a first study protocol prior to its completion activate a second study protocol and after processing one or more steps of the second study protocol return to the first study protocol and continue operation from a point at which the first study protocol was suspended 2 The invention of claim 1 wherein one of the first and second study protocols comprises a stress echo protocol and the other comprises a contrast protocol 3 The invention of claim 1 wherein the medical diag nostic imaging system comprises an ultrasound imaging system 4 The invention of claim 1 wherein the processor imple ments a finite state machine 5 The invention of claim 1 wherein the medical diag
23. h stage of a staged protocol or at the beginning of a defined acquisition sequence etc Enable disable to automatically transfer specifically defined types of data to specifically defined devices or locations such as transfer clips over the network at the end of each clip capture transfer still images to a CD at the end of exam etc Enable disable annotations or pictograms upon the occur rence of some user or system event Enable disable automatically performing a specific mea surement upon the occurrence of some user or system event Enable disable entry into a specific measurement and or report package upon the occurrence of some user or system event Enable disable system guidance such as a guidance to the user on the next step to perform for a specific type of exam Enable disable to automatically change the imaging mode based upon the occurrence of some user or system event Acquisition Sequence Define a set of imaging acquisition steps where each step would have varying imaging acquisition parameter definitions the system could automatically move through the acquisition steps or could move through the acquisition steps based upon the occurrence of some user system event In yet another embodiment an automated exam measure ment sequence icon is presented to improve work flow of examinations Ultrasound systems usually provide a menu for the selection of measurements to be performed during an exam Once invoked the m
24. he clip the user will label the clip with the appropriate View label Ge PLAX etc The user is ready to continue the exam The user selects to exit Review and return to live image acquisition The user injects pharmacological drug to increase the patients heart rate The user injects the patient with the Contrast agent and invokes the Contrast acquisition sequence and begins image acquisition The user selects the Clip Capture button to capture clips for each of the 4 views A2C A4C PSAX PLAX for the Low Dose stage The user selects the clips he wants to keep the ones that captured the anatomy clearly As part of selecting the clip the user will label the clip with the appropriate View label ie PLAX etc The user is ready to continue the exam The user selects to exit Review and return to live image acquisition The user increases the injected amount of pharmacological drug to increase the patient s heart rate even higher When the patient s heart rate is where the physician wants it to be the user injects the patient with the Contrast agent and invokes the Contrast acquisition sequence and begins image acquisition The user selects the Clip Capture button once for a continuous capture This captures clips for each of the 4 views PLAX PSAX A4C A2C for the Peak Dose stage When finished the user selects the Clip Capture button to stop the Continuous Clip capture The user selects
25. he macros via the user interface 150 The processor 120 then creates a study protocol from the selected macros In this way the user can select portions of already defined protocols via the list of macros and put them together to form a new user defined group protocol This eliminates the need for a user to redefine a whole new protocol In software the term macro is often used to describe a segment script or skeleton that can be used by another process preferably repeatedly and in more than one way For example in Excel one can build a macro preferably in Visual C to perform a sequence of instructions Once built the macro can be used repeatedly with a given spreadsheet or moved easily to another spreadsheet and be used there potentially in a significantly different context Accordingly the term macro means any sequence of instructions that can be interpreted by another process causing that process to execute or have executed a sequence of instructions Macros can be exceedingly useful as building blocks for the Protocol Controller 160 With respect to the Protocol Con troller 160 consider a macro to be a set of parameter definitions that define specific ultrasound system behavior Each macro or set of parameters can be used as ultrasound preset data values or ultrasound system controlling param eters Every protocol will consist of some set of macros Once a macro has been defined it belongs to a pool of defined m
26. ived the next state depends on the current state as well as the event A change of state caused by an event is called a transition A state model diagram is a graph whose nodes are states and whose directed arcs are transi tions labeled with event names There can be guards and actions associated with state transitions as well as state entry and state exit actions The finite state machine repre sents a collection of hierarchical states where only one sub state is current at any time An application can have multiple states by having multiple finite state machines The state model diagram of a given protocol is used to initiate the execution of the application functionality It is driven by events which are due to user actions There can be concur rent finite state machines active at the same time and they can communicate by sending messages which may cause state transitions and actions to be executed The finite state machine model definition is defined in a file using a state model meta language This allows a concise definition of all the information represented in the state model diagram No software coding is required to define the states or their relationships and transitions of the state model diagram The states and some of their relationships and transitions can be changed without having to recompile and re build the soft ware Each protocol has its own set of parameters that are defined by the protocol and get initialized when the
27. label as the user assigns View labels to their selected clips System transitions from review to live imaging The SE Protocol Controller is in Imaging state Peak Dose stage PLAX view The Contrast protocol acquisition sequence will transmit using the defined parameters above Every N 1 N 0 initially heart beats the system will transmit a burst of 5 frames of high power followed by transmitting low power The system begins a Continuous Clip capture Clips per Capture Continuous where each clip is 2 heart beats long Lo ROI size Duration per Clip 2 heart beats 1 4 ROI size The user moves the transducer through all 4 views to capture clips of each view The system will NOT transition from live imaging mode to review Clip Auto Review Off of the clips that were captured The system transitions from live imaging mode to review of the clips that were captured The Protocol Controller knows the View Sequence of this Pharmacologic Stress Echo exam The protocol will default the clip label to the next View label as the user assigns View labels to their selected clips US 6 953 433 B2 9 TABLE 4 continued User Input System Response The user selects to end the exam The Protocol Controller was initialized for the Pharmacologic Stress Echo protocol to delete all clips that 10 are not selected as clips to keep at the end of the exam Clip Auto Delete On The clips not selected as clips to keep a
28. nostic imaging system further comprises a display device and wherein the processor is further operative to display an icon on the display device that represents an automated sequence of exam measurements wherein the icon displays a name of a currently active measurement and a tool tip that displays a next measurement in the sequence 6 The invention of claim 1 wherein at least one of the study protocols comprises a staged protocol 7 The invention of claim 1 wherein at least one of the study protocols comprises a non staged protocol 10 15 20 25 30 35 16 8 The invention of claim 1 wherein the medical diag nostic imaging system further comprises a user interface and wherein said plurality of study protocols is comprised of a collection of macros for controlling one or more of the following imaging system settings the user interface a display area on a display device and a system peripheral 9 The invention of claim 8 wherein the processor is further operative to receive user selection of two or more macros via the user interface and create a study protocol from the selected macros 10 The invention of claim 9 wherein the collection of macros comprises at least one of the following a clip capture macro a clip playback macro a workflow macro and an acquisition sequence macro 11 The invention of claim 9 wherein at least one of the macros controls one or more of the following transmit parameters
29. ore contrast injecting contrast media and imaging the target organ after contrast At the point of injection the user often would like to initiate a timer to keep track of elapsed time from injection During imaging and after contrast injection a different imaging mode is typically used with a completely different suite of imaging parameters To document this procedure a differ ent set of clip capture parameters are typically used for pre injection vs post injection clips By allowing aspects of system operation to be coordinated in a user customizable pre defined way a user can nest a pre defined stress echo protocol with a pre defined contrast protocol to define one integrated protocol that combines the two protocols In this way pre defined protocols can be combined almost like building blocks and work together to create new and novel applications Table 1 shows this combination of stress echo and contrast protocols conceptually from the user s point of view TABLE 1 User Input System Response Start the rest phase of a stress Initiate exam he stress protocol Capture clips to document resting Capture clips phase without contrast Inject contrast media Initiate the contrast protocol within the context of the stress echo protocol A new suite of capture parameters is used optimized for contrast Return to standard imaging using clip capture parameters optimized for peak stress Capture clips Captu
30. rast acquisition sequence is not active The ContrastAcquisition state 314 is when the system is in live image acquisition and a contrast acquisition sequence is active The ContrastAcquisitionSequences finite state machine 319 has as many contrast sequences as desired There are different ways that the live image acquisition is performed For example instead of Normal acquisition where the sys tem just transmits a contrast sequence may transmit each time the patient s r wave occurs for some number of r waves e g 5 and the first transmit may use a high mechanical index MI and the subsequent transmissions may use low MI The purpose being that the first transmit with high MI is to burst the contrast bubbles and the following transmits are to allow the system to capture an image but not burst any contrast bubbles This allows the user to see and capture reflow or perfusion of blood into an area in the anatomy e g liver heart muscle or ventricle In another embodiment a user can select a factory defined protocol modify a factory defined protocol thereby mak ing it a user defined protocol or create a new protocol Preferably the storage device 140 stores a collection of macros for controlling one or more of the following imag ing system settings the user interface a display area and a system peripheral The processor 120 displays a list of macros on the display device 130 and receives a user selection of two or more of t
31. re lt datatype gt to lt devicetype gt In this way each segment of the protocol can be written as a macro utilizing parameter The protocol itself can then be imple mented as an engine used to drive a series of macros This development is particularly useful in that the engine i e the Protocol Controller 160 can be interrupted after execution of a macro the sequence can be marked to indicate where to re enter and the user can run another sequence of macros protocol before returning to the exit point and continuing execution of the original protocol As mentioned above the collection of macros controls one or more of the following imaging system settings the user interface a display area and a system peripheral More specifically the macros can control one or more of the following transmit parameters and settings receive param eters and settings imaging mode imaging parameters and settings filters and processing specifics signal processing options post processing options frequency harmonic mode pulse repetition frequency frame rate display control number of views annotation a user interface page displayed in the display area an active tool displayed in the display area a cursor in the display area a number of views in the display area system control measurements and reports annotations pictograms review and display features user preferences which user interface page is displayed and which tool cursor is
32. re clips to document resting phase with contrast Move the stress protocol to the next stage peak exercise Capture clips to document peak stress without contrast Inject contrast media Initiate the contrast protocol within the context of the stress echo protocol A new suite of capture parameters is used optimized for contrast Capture clips to document resting phase with contrast The following shows in more detail how two different protocols here pharmacologic stress echo and contrast can be active and used together at the same time Tables 2 and 3 set forth the protocol parameter definition values for 10 15 20 25 30 35 40 45 50 55 60 65 4 pharmacologic stress echo and contrast protocols and Table 4 provides a description of the actions taken by the user and the ultrasound system s response for each stage in the protocol It should be noted that this is merely an example and the details set forth in this example should not be read into the claims TABLE 2 Protocol Parameter Definition Values for Pharmacologic Stress Echo Protocol Stage Sequence Baseline Low Dose Peak Dose Clip Auto Delete On Auto Next Stage On Clip Playback Speed 50 Clip Playback Mode Loop aligned Clip Capture parameter values for Baseline Stage View Sequence PLAX PSAX A4C A2C Clips per Capture 4 Clip Capture Method Prospective Compression Rate Medium Duration per
33. re deleted when the patient record is closed In the examples set forth above two different protocols were active and used together at the same time In a more general embodiment the concept of nested protocols can be used to automatically change the control of the ultrasound system at each stage of a multi stage study protocol sequence Such optimization can be used to improve image quality and study workflow and can involve changing anno tations and or DICOM settings In this way nesting two or more different protocols so that a segment of one study protocol is inserted into another study protocol can be viewed as a particular example of changing the control of the ultrasound system at each stage of a multi stage study protocol sequence It is presently preferred that the Protocol Controller 160 be implemented as a software implemented finite state machine Of course other implementations can be used Finite state machines are known in the art and are described in for example chapter 5 of Dynamic Modeling in Object Oriented Modeling and Design by Rumbaugh Blaha Premerlani Eddy and Lorensen which is hereby incorpo rated by reference It is preferred that the finite state machine design pattern be implemented in such a way that the finite state machine software allows the Protocol Controller 160 to implement a state model diagram in a highly configurable way A state model diagram relates events and states When an event is rece
34. ve a selection on the display that would allow him to select a specific stage to go to That is how this event would be sent out There could be other ways that the SelectStageEvent gets sent out When a Clip capture is finished an EndOfCaptureEvent would be sent out If the guard functions indicated that the Clip Auto Review parameter was not set to End of Capture or End of Stage and that the Auto Next Stage parameter was set to On then the finite state machine would automatically move to the next Stage View are the same as Stages only for Views Viewl View2 View 10 As with Stages a maximum of ten US 6 953 433 B2 11 views were selected for this example since most Stress Echo studies use four to six views These correspond with the user views such as Viewl would be the stress echo PLAX view View2 would be the PSAX view etc The entry function doContrastAcquisition has a guard function ofisContrastOn If contrast is enabled for this view then the system could automatically activate the Contrast protocol by sending an event ContrastAcquisitionEvent Turning now to FIG 3 the Contrast protocol finite state machine 300 comprises two concurrent finite state machines AcquisitionStates 310 and ContrastAquisitionSe quences 320 The AcquisitionStates finite state machine 310 has two states NormalAquisition 312 and ContrastAcqui sition 314 The NormalAquisition state 312 is when the system is in live image acquisition and a cont
35. vention is defined by the following claims and nothing in this section should be taken as a limitation on those claims By way of introduction the embodiments described below relate to a protocol controller for a medical diagnostic imaging system In one embodiment two or more distinct study protocols are active on a medical diagnostic imaging system at the same time In another embodiment control of a medical diagnostic imaging system is changed at each stage of a study protocol sequence to optimize study per formance In yet another embodiment a protocol is created from a collection of macros that control a medical diagnostic imaging system Other embodiments are provided and each of the embodiments described herein can be used alone or in combination with one another The embodiments will now be described with reference to the attached drawings BRIEF DESCRIPTION OF THE DRAWINGS FIG 1 is a block diagram of a medical diagnostic ultra sound imaging system of an embodiment FIG 2 is a stress echo state transition diagram of an embodiment FIG 3 is a contrast state transition diagram of an embodi ment DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS By way of introduction the embodiments described below relate generally to protocols used in a medical diag nostic imaging system Although any type of imaging sys tem can be used these embodiments will be illustrated in conjunction with an ultrasound imaging
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