WO2009077983A1

WO2009077983A1 - Apparatus, systems and methods for ultrasound imaging

Info

Publication number: WO2009077983A1
Application number: PCT/IB2008/055353
Authority: WO
Inventors: David Rust; Mckee Poland
Original assignee: Koninklijke Philips Electronics, N.V.
Priority date: 2007-12-17
Filing date: 2008-12-16
Publication date: 2009-06-25

Abstract

Apparatus, systems and methods are provided for portable diagnostic imaging whereby mobility, functionality and battery life of a scanning device/system are optimized. Additionally, the disclosed apparatus, systems, and methods include highly interchangeable elements allowing for maximum customization by users for specific applications and/or personal preferences. The systems/apparatus generally include a probe element and a pod element, wherein the probe element contains means for obtaining imaging data (e.g., a transducer array) and the pod element includes a user interface and display for scan-alone operability. The apparatus/system also generally includes means for communicating with a host system (e.g., wireless transmitter) for companion mode operability. Systems disclosed generally include a probe/pod device integrated with one or more host systems (e.g., PCs).

Description

APPARATUS, SYSTEMS AND METHODS FOR ULTRASOUND IMAGING

The present disclosure is generally directed towards the field of ultrasound imaging. More particularly, exemplary embodiments of the present disclosure are directed towards apparatus, systems and methods for portable ultrasound imaging. Exemplary embodiments of the present disclosure are also directed towards optimization of portable ultrasound imaging apparatus/systems, e.g., portable systems with enhanced durability, performance, functionality, power management, user interface (UI) and/or adjustability.

Ultrasound imaging apparatus, systems and methods used today are typically embodied in stand-alone configurations, e.g., housed on a cart, in a laptop-sizes assembly, or in a handheld box. Conventional ultrasound imaging apparatus/systems typically operate via one or more transducer probes connected to a main processing unit (e.g., cart, laptop, handheld) by means of a cable that typically contains 50 to 200 conductors, whereby raw or minimally processed data is relayed from the probe(s) to the processing unit. The probes typically contain a piezoelectric sensor array, passive electrical components for signal conditioning, and an interface to the cable. Thus, in general, the probes are relegated to performing the limited function of data acquisition, while the associated processing unit is responsible for all other functions, e.g., data processing, image formation/display, user interface (UI) control, etc. Recent advances in miniaturization and power reduction of electronic circuits now make it feasible to construct ultra-compact battery operated hand held imaging devices as advantageous alternatives to current apparatus/systems. Ideally, these devices would essentially reallocate some or all of the functionality traditionally characteristic of the processing unit into an improved probe apparatus/system with stand-alone ability. However, many obstacles/problems remain to be resolved before this goal is attainable.

One essential problem in the development of ultra-compact imaging devices relates to integration of a functionally acceptable user interface. Essentially, due to compacting, the quantity and layout of possible user controls are limited and, often times, insufficient to cover the wide range of functions/controls needed. Mobile phone producers have addressed similar problems by implementing deep, complex menu hierarchies typically accessed by a four-way rocker switch. This technique, however, forces the user to navigate repeatedly through multiple levels of menus to reach even the most commonly needed functions. Furthermore, some desirable user controls for ultrasound imaging, e.g., time gain compensation (TGC) sliders, gain knobs, mode buttons, and the like, cannot be adequately integrated into an ultra-compact device in any useful form. As a result, device designers and users are required to accept reduced and/or omitted functionalities.

Moreover, extra circuitry and processing power, such as is needed to accommodate real time inputs from the user interface (UI), further complicate the potential design of an ultra-compact device. Essentially, the greater the number of UI controls integrated into a device, the more circuitry is required to poll and connect those controls to a local processor, and the more processing power is required to pre-process UI control data (e.g., to provide real time feedback to the user through other elements on the same ultra-compact device, such as a display). The extra circuitry burdens the ultra-compact device with cost, complexity and power-consumption (which translates to reduced battery life). For ultra- compact devices that further incorporate wireless communication functionalities with a base system, cost, complexity and power-consumption burdens are amplified due to, inter alia, competing circuit demands of beamforming, signal processing and wireless transmission circuitry. Inclusion of a separate remote control device is an option to address the noted design difficulties/restrictions. However, a separate remote control offers, at best, a suboptimal solution for several reasons. For example, a separate remote control would add yet another device to an end user's tool requirements to perform desired ultrasound procedures. The remote control would also require another battery and charger, further complicating maintenance and cost. Further, a separate remote control device would translate to another component that is subject to loss and/or theft. Separate control and scanning devices also reduce the portability of the system and increase overall system complexity, essentially reverting back to the configuration of traditional systems.

Given the obstacles/problems in the design and development of ultra-compact imaging devices, new and improved apparatus, systems and methods are needed that incorporate complete functionality of traditional larger systems without sacrificing desirable characteristics and functionalities, such as compactness, battery life and ease of use. The apparatus, systems and methods of the present disclosure advantageously address and/or overcome the obstacles/problems noted herein. Advantageous apparatus, systems and methods for portable ultrasound imaging are provided according to the present disclosure. Exemplary embodiments of the disclosed apparatus, systems and methods provide simple, compact and mobile alternatives to traditional larger ultrasound imaging systems. The disclosed ultrasound imaging apparatus, systems and methods may be advantageously applied to and/or utilized in a broad range of diagnostic and/or therapeutic ultrasound imaging applications. Exemplary applications of the disclosed ultrasound imaging functionalities include, but are not limited to, cardiac stethoscopes, devices for providing prenatal care and related diagnostics, ultra-mobile ultrasound image acquisition devices, ultrasound applications for third-world and/or emerging markets, emergency medicine (ER or Aid Car) applications, anesthesiology nerve block applications, and line placement applications.

Exemplary embodiments of the disclosed apparatus, systems and methods include a wireless transducer-based ultra-compact imaging device, wherein a substantial amount of the "front end" beamforming and signal processing circuitry is miniaturized, combined with a power supply (such as a battery) and a transmitter (e.g., infrared, radio and the like), and housed along with a transducer probe as a single device/assembly. The resulting device generally offers both scan-alone functionality ("stand-alone mode") and the ability to operate in conjunction with a host system ("companion mode"). The disclosed compact-imaging device typically includes a probe element and a pod element. The probe element defines, in essence, an ultra-compact ultrasound acquisition subsystem. In exemplary embodiments, the probe element interfaces with a second element, e.g., the disclosed pod element or directly with a processor/PC, to define a fully operational system. Interface between the probe element and the pod element (or other ancillary components) is generally accomplished via an industry standard means, e.g., ExpressCard, CardBus, USB, Ethernet, and the like.

In exemplary embodiments of the present disclosure, the probe element includes a transducer array probe that is connected relative to a computer insertable medium, such as an ExpressCard or CardBus, e.g., by means of a thin cable with approximately 70 conductors. The ExpressCard is a new standard for plug-in PC cards, similar to the

PCMCIA card widely supported amongst notebook and laptop PCs. When operated in the companion mode, the disclosed probe element may be integrated with a host system by plugging the insertable medium into a processor/PC of any form factor, wherein the processor/PC is typically running host software for receiving and displaying US signals, e.g., QLab™ ultrasound quantification software available from Philips Medical Systems (Bothell, WA).

The disclosed probe element may be combined with a pod element to define an assembly adapted for use in a "stand-alone" mode and/or a mobile "companion mode" The pod element generally includes a transceiver (e.g., an ultra wide band (UWB) transceiver), an antenna, a power source (e.g., one or more batteries), and power management elements that are housed in a single enclosure. UWB transceivers are generally adapted to simultaneously transmit ultra-low power radio signals with very short electrical pulses across a broad frequency range. Thus, the disclosed probe element may be integrated with the pod element within a relatively small, single enclosure. In exemplary embodiments, the probe element connects to the pod element directly or indirectly through a cable, e.g., a 70 conductor bundle. The pod element typically includes a receiving port for the chosen means of connection, e.g., ExpressCard, CardBus, USB, Ethernet and the like, wherein such receiving port allows for the changeability between different probe elements.

Alternatively, the cable may be fixedly/permanently connected with respect to the pod element.

In exemplary embodiments, the disclosed probe element communicates wirelessly via wireless functionality associated with the pod element. Such wireless communications may be received by a host system that is remotely located in a convenient location, e.g., a location with an appropriately controlled environment and/or ready access to power. Such communications advantageously support highly mobile operations, i.e., companion mode operations, of the disclosed probe/pod-based system. In other exemplary embodiments, the pod element includes a user interface and display, whereby limited or full scanning operations can be controlled, initiated and accomplished without integration and/or communication with a host system, i.e., in a stand-alone mode.

Inclusion of a user interface (UI) and display as part of the pod element further requires incorporation of a processor/integrated circuit(s), operating system (OS) and application software (SW) therein, with associated balancing between functionally/features and power management and design complexity. The apparatus, systems and methods of the present disclosure advantageously enhance/maximize functionality/features, while minimizing power consumption/complexity. Thus, in exemplary embodiments of the present disclosure, the UI of the pod element is structured and configured so as to enhance/maximize functionality/features while minimizing power consumption/complexity by: (i) using preset user/instance configurations stored in non-volatile memory to minimize data processing and pre-processing requirements, (ii) allowing for or otherwise accommodating belated/subsequent or concurrent processing of data by a host system, (iii) selectively increasing the functionality of the UI when the device/system is operating in companion mode, and (iv) avoiding/minimizing pre-imaging setups.

The user is typically allowed and/or required to configure the disclosed pod element at least once using a full-featured host system, e.g., using an application supporting communications therebetween. Requisite application support is typically incorporated into and provided by host system software that is designed/adapted to control and display the ultrasound images. Configuration of the pod element may be controlled/managed through broad set of user interface (UI) controls on the host system and/or through functionality associated with the UI controls on the pod element. The resulting user configuration(s) are generally stored by the pod element as named presets in non-volatile memory. Real-time scanning of a subject/target while the system is operating in companion mode can also be used to create/optimize user configurations. In exemplary embodiments, the image of a subject/target may be displayed both on the host system display and on the device display, thereby facilitating user configuration adjustments/settings using either (or both) control sets.

A plurality of presets can be stored by the disclosed system, e.g., the pod element. The presets may be advantageously indexed, e.g., by user name and/or application type. The presets may be recalled and/or accessed, as and when desired, using the user interface (UI) on the pod element, e.g., during stand-alone operation. Of note, the stand-alone operation mode may be effected and/or initiated by disconnecting the pod element from a host system, e.g., by physically disconnecting a cable-based connection, disabling a wireless connection and/or removing the pod element from the operable range of the wireless connection. In the stand-alone mode, the user presets may be recalled to enable use of the device as an independent hand-held scanner/imaging system. While disconnected from or otherwise out-of-communication with a host device , the user interface (UI) of the pod element is generally reduced in functionality. The pod element thus typically allows for the selection based on available presets and only a limited feature set therebeyond. In exemplary embodiments, removable non-volatile memory media, e.g., secure digital (SD) cards, are used to store presets. Thus, users may be able to swap SD cards containing preferred configurations for a commonly used/shared device. In addition, images/data captured by the device in stand-alone mode may be stored on removable media for later transfer and analysis by a host system. Thus, an advantageous characteristic of exemplary embodiments of the present disclosure relates to user interface (UI) simplification by off-loading input intensive activities to a companion application run on a larger host system, such as a PC, medical workstation or conventional cart-based ultrasound system. Illustrative activities that can be off-loaded in this manner include patient data entry, detailed measurements/reports and device configuration/set-up. In exemplary embodiments, a companion application may communicate with the device, i.e., sync-up therewith, either wirelessly or through detachable cabling. When cabled/wired to a host system, the device may realize further benefits, e.g., battery charging. Additional features, functions and benefits of the disclosed apparatus, systems and methods will be apparent from the description which follows, particularly when read in conjunction with the accompanying figures.

To assist those of ordinary skill in the relevant art in making and using the subject matter hereof, reference is made to the appended drawings, wherein: Figure 1 schematically depicts the design/communication functions associated with a traditional ultrasound system;

Figure 2 schematically depicts an exemplary compact scanning device in communication with a traditional cart/compact ultrasound system, according to the present disclosure; Figure 3 schematically depicts an additional exemplary compact scanning device in communication with a traditional cart/compact ultrasound system, according to the present disclosure;

Figure 4 schematically depicts a further exemplary compact scanning device in communication with a traditional cart/compact ultrasound system, according to the present disclosure;

Figure 5 schematically depicts an exemplary compact scanning device according to the present disclosure which is in communication with a companion application, ;

Figure 6 schematically depicts a further exemplary compact scanning device in communication with a companion application, according to the present disclosure; Figures 7-14 schematically depict exemplary configurations and assemblies according to the present disclosure;

Figure 15 depicts an exemplary form factor for a compact scanning device according to the present disclosure; and Figurelό depicts an exemplary mapping of ultrasound controls onto a UI for a compact scanning device according to the present disclosure.

Apparatus, systems and methods for ultrasound imaging are provided according to the present disclosure. In general, the present disclosure is directed to apparatus/systems that include a probe element and a pod element, which are together referred to as a compact-scanning device (CSD). The disclosed CSD apparatus and systems are generally integrated with one or more host systems for advantageous operation thereof.

Exemplary probe elements according to the present disclosure include means for obtaining ultrasound imaging data for the desired imaging application(s), e.g., a transducer array for ultrasonic (US) imaging applications. In exemplary embodiments, the probe element is derived from or resembles the S5-1 transthoracic transducer available from Philips Medical Systems (Bothell, WA). In exemplary embodiments, the pod element does not replicate the probe element's circuitry, but instead (i) integrates a probe element's circuit board internally and/or (ii) accepts an insertable media (wired relative to the probe element), e.g. an ExpressCard/54 shell, as an interchangeable plug-in module.

The pod element generally includes a power source (e.g., battery), a power management system, and means for communicating with a host system (e.g., ExpressCard, USB, Ethernet, wireless, infrared, etc.). In exemplary embodiments of the present disclosure, the integrated pod/probe transmits data via the pod element to a host system (e.g., a PC) for further processing and display. The pod element may be advantageously enclosed in a box-like structure, e.g., a housing that is approximately the size of a conventional video/MP3 player (e.g., a Microsoft Zune™), although it is expressly contemplated that different size models may be produced with differing degrees of standalone functionality. In exemplary embodiments, the disclosed CSD is self-powered from a lithium technology battery located in the pod element, and can run more than one hour between charges. The battery may be charged in conventional ways, e.g., via a USB connection to a host system or by an optional charging cradle. Thus, in exemplary embodiments, power management circuitry manages charging the battery from charging cradle input or a USB port. The power management circuitry may also convert the battery voltage to a requisite voltage supply, e.g., 3.3V, for use/operation of the pod and probe elements.

The disclosed pod element generally includes a user interface (UI), at least one display, memory (e.g., non-volatile memory such as SD cards), an abbreviated operating system (OS) and limited software (SW), for imaging operations independent of a host system. In exemplary embodiments, a removable storage media (e.g., SD card) can be used to store user presets (e.g., imaging configurations). These user presets can then be accessed using the CSD's UI, increasing power efficiency and minimizing CSD processing drains. The pod element's display typically has at least one-quarter-VGA resolution and dimensions of at least 3" on the diagonal.

Exemplary display types utilize LCD or OLED technology, although alternative display technologies may be employed without departing from the spirit or scope of the present disclosure. The displays are generally adapted to depict ultrasound images, status and configuration information, and UI feedback. Additional and/or alternative information/images may be delivered to the display in specific implementations of the present disclosure, as will be apparent to persons skilled in the art.

The pod element's user interface (UI) generally contains limited, dedicated UI controls for image acquisition. Exemplary control sets may include, but are not limited to, rotary buttons, capacitive sliders, or the like. In exemplary embodiments, the control sets of the UI are at minimum used to select between user presets. The control sets of the UI may also include limited imaging function controls, e.g., freeze, acquire, mode, depth, gain, scale, ROI position and the like. The UI may be simplified relative to conventional systems by limiting the controls and control functions to those necessary and/or relating to a specific dedicated clinical and/or diagnostic application, e.g., cardiology, GI, etc.

In exemplary embodiments, the pod element's non-volatile memory is in the form of built-in flash memory, a removable SD card, or a combination of both. If an SD card (or similar removable media) is used, different particular user's presets can be swapped into the CSD by changing the SD card. This allows for an end product that can be easily and quickly customized for different clinical applications and/or for a particular user's individual preferences. Stock presets for CSDs may be made available for download from an instrument manufacturer, e.g., on a support website or by request. Thus, a particularly beneficial aspect of the disclosed apparatus/systems relates to a user's ability to change probe elements and/or memory cards depending on the requirements for a specific imaging application and/or user preference. Accordingly, the disclosed apparatus/system minimizes complexity while maximizing overall functionality and customization abilities.

SD cards may also be removed from the CSD for preset programming purposes. Thus, in exemplary embodiments, a CSD SD card can be programmed using a host system, independent of the CSD itself. A CSD design with both limited built-in flash memory and an SD card may be optimal, resulting in both the ability to rapidly switch presets using the SD card and the guarantee/assurance of stock presets in the flash memory in cases where the SD card is missing or non-functional. In exemplary embodiments, images captured in stand alone mode may be stored in the non-volatile memory, e.g., for later transfer, viewing and/or analysis by or with a host system. Image data stored on an SD card (or similar removable media) can easily be transferred to a host system via a memory card reader/adapter. Image data stored on an internal Flash drive (or similarly embedded memory) can be transferred to a host system via the wireless or wired connection of the pod element to the host system.

To better understand the design and operation of the advantageous ultrasound imaging apparatus, systems and methods of the present disclosure, reference is made initially to the schematic depiction of a traditional ultrasound system 10 set forth in Figure 1. As depicted therein (and throughout the schematic depictions presented herein), two- way communications between elements are indicated by two-headed arrows. Thus, in ultrasound system 10, transducer 12 is in two-way communication with a traditional cart/compact ultrasound system 14. In particular, transducer 12 is generally in two-way communication with beamformer functionality 16 over a transducer cable 18. Transducer cable 18 generally takes the form of a cable with 150 to 300 conductors. The ultrasound signals are further processed with or by signal conditioning functionality 20, an image processor 22, and such signals are then delivered to a display 24. As further noted/depicted in Figure 1, the beamformer functionality 16, signal conditioning 20, image processor 22 and display 24 are subject to control through a user interface 26. Patient management and post-imaging applications 28 generally interact with and/or drive operation of image processor 22 and display 24. Typical patient management and post-imaging applications 28 include patient data, measurements, image annotation, image quantification and DICOM connectivity. Communications within the traditional cart/compact ultrasound system may be termed "inter-module" communications and may be achieved through traditional communication channels, e.g., internal wiring, PCB traces and the like. Turning to Figure 2, an exemplary compact scanning device (CSD) 40 according to the present disclosure is schematically depicted. CSD 40 includes a probe element 42 and a pod element 44. The pod element 44 is adapted for communication with a traditional cart/compact ultrasound system 46. Thus, probe element 42 includes a transducer 48 and initial beamformer functionality 50. Probe element 42 communicates with pod element 44 via a transducer cable 52, e.g., a thin transducer cable that may include, for example, 70 conductors. The pod element 44 includes final beamformer functionality 54 and signal conditioning functionality 56. The user is able to control operations of the pod element 44 through a simplified, set-up driven user interface (UI) 58. Communications within the pod element 44 are inter- modular, e.g., through internal wiring, PCB traces or the like.

With further reference to Figure 2, the design/operation of CSD 40 is further based upon interaction with traditional cart/compact ultrasound system 46. Live imaging UI and control functionality 60 interacts/communicates with the pod element 44, as schematically depicted. Thus, in exemplary embodiments of CSD 40, live imaging UI and control functionality 60 effects control of the pod element 44 through data exchange and communications delivered across conventional USB cables, PCIe connections and the like. Similarly, ultrasound signals that have been processed by the signal conditioning functionality 56 of pod element 44 are generally delivered to image processor 62 and then to display 64 associated with traditional cart/compact ultrasound system 46. Such data exchange and communications are generally delivered across conventional USB cables, PCI Express (PCIe) connections and the like. As noted in Figure 2, patient management and post imaging applications 66 may be effected with respect to the image processor 62 and display 64 (e.g., patient data, measurements, image annotation, image quantification, and DICOM connectivity). Communications within and/are among components and functionalities associated with the traditional cart/compact ultrasound system 46 are typically effected through inter-module communication means, e.g., internal wiring, PCB traces and the like.

Turning to Figure 3, an alternative exemplary compact scanning device (CSD) 100 is schematically depicted according to the present disclosure. As is apparent from a comparison of Figure 2 and Figure 3, CSD 100 shares certain features and functionalities with CSD 40. However, with reference to Figure 3, CSD 100 does not include a pod element, but instead incorporates features/functionalities associated with pod element 44 (for CSD 40) into probe element 102. Indeed, probe element 102 includes transducer 104, initial beamformer functionality 106, final beamformer functionality 108 and signal conditioning 110. User control of probe element operations, e.g., final beamformer/signal conditioning functionalities, is achieved through a simplified set-up driven user interface (UI) 112. Communications within probe element 102 are inter-modular, e.g., based on internal wiring, PCB traces or the like.

With further reference to Figure 3, operative aspects/functionalities of probe element 102 are in communication with a traditional cart/compact ultrasound system 114. Thus, live imaging UI and control functionality 116 communicates (e.g., via USB, PCIe and the like) to control operation of the final beamformer functionality 108 and signal conditioning 110 of probe element 102. Ultrasound signals are communicated from the signal conditioning functionality 110 of probe element 102 to image processor functionality 118 (and then on to display 120) associated with traditional cart/compact ultrasound system 114, e.g., via USB, PCIe and the like. Patient management and post imaging applications 122 may be effected with respect to the image processor 118 and display 120 (e.g., patient data, measurements, image annotation, image quantification, and DICOM connectivity). Communications within traditional cart/compact ultrasound system 114 are generally intermodular, e.g., based on internal wiring, PCB traces or the like. Thus, CSD 100 eliminates the need for a pod element (as compared to CSD 40), while maintaining comparably advantageous features and functions.

Turning to Figure 4, a further exemplary compact scanning device (CSD) 150 is schematically depicted. CSD 150 includes a probe element 152 and a pod element 154 that communicate with each other via conventional means, e.g., USB, PCIe or the like. Probe element 152 includes a transducer 156, initial beamformer functionality 158, final beamformer functionality 160, and signal conditioning functionality 162. Communications within probe element 152 are generally inter-modular, e.g., through internal wiring, PCB traces or the like. A simplified set-up driven user interface (UI) 164 is associated with and controlled at pod element 154. UI 164 controls functionalities associated with both the probe element 152 and the pod element 154. As schematically depicted in Figure 4, UI 164 is advantageously adapted to interact with and control the final beamformer functionality 160 and signal conditioning functionality 162 associated with probe element 152, and also image processor 166 and display 168 that are associated with pod element 154. Communications within pod element 154 are inter modular (e.g., through internal wiring, PCB traces or the like), whereas communication from UI 164 to probe element 152 are cable based, e.g., USB, PCIe or the like.

Probe element 152 and pod element 154 of CSD 150 also communicate with traditional cart/compact ultrasound system 170, e.g., over USB, PCIe or the like. Thus, system 170 generally includes live imaging UI and control 172 that communicates with/controls functionalities of probe element 152 (e.g.., via USB, PCIe or the like), such as the final beamformer/signal processing functionalities. In this way, two modes of control of such functionalities are provided, one control being actuable from system 170 and the other control being actuable from pod element 154. System 170 also includes image processor 174 and display 176, which allow a user to view ultrasound images captured by transducer 156 at or with both pod element 154 and system 170. As with the previously described exemplary CSD embodiments, system 170 may include/support patient management and post-imaging applications 178 (e.g., patient data, measurements, image annotation, image quantification, DICOM connectivity and the like), and such applications 178 may be communicated internally (through inter modular communication channels) and to image processor 174 and display 176.

Turning to Figure 5, a further exemplary compact scanning device (CSD) 200 is schematically depicted according to the present disclosure. CSD 200 includes probe element 202 and pod element 204. Probe element 202 includes a transducer 206 and initial beamformer functionality 208 which communicate with each other through inter-modular means, e.g., internal wiring, PCB traces or the like. Pod element 204 includes final beamformer functionality 210, signal conditioning functionality 212, image processor 214 and display 216. Probe element 202 communicates with pod element 204 via cabling, e.g., a thin transducer cable that includes, e.g., 70 conductors.

With further reference to Figure 5, pod element 204 includes simplified live imaging UI and control 218 that permits a user to control and/or interact with the components/functionalities associated with pod element 204. In addition, pod element 204 is in communication with a companion application 230 that includes/supports various functionalities, e.g., patient management and post-imaging applications. Thus, for example, such patient management/post-imaging applications may include patient data, measurements, image annotation, image quantification, DICOM connectivity and the like. Companion application 230 and pod element 204 communicate through conventional means, e.g., via USB, PCIe or the like. Thus, CSD 200 advantageously transfers substantial functions and UI control to the pod element, thereby enhancing the overall system flexibility hereof. CSD 200 is a fully functional stand alone, compact ultrasound device which is particularly adapted for operation in a stand alone mode. However, through communication with companion application 230, additional functionalities may be advantageously achieved, e.g., prior to and/or subsequent to ultrasound image capture by transducer 206 of probe element 202. For example, CSD 200 may operate in conjunction with companion application 230 for setup, patient data entry, measurements, printing, and archiving. Indeed, companion application 230 allows the CSD 200 to have a simple UI, yet still provide the user with a rich set of capabilities.

With reference to Figure 6, a further exemplary compact scanning device (CSD) 250 is schematically depicted according to the present disclosure. CSD 250 is adapted to communicate with a companion application 280 in a similar manner to that described with reference to Figure 5. Thus, CSD 250 includes a probe element 252 and a pod element 254. Probe element 252 includes a transducer 256, initial beamformer functionality 258, final beamformer functionality 260, and signal conditioning functionality 262. The components and functionalities associated with probe element 252 are adapted for inter modular communication, e.g., through internal wiring, PCB traces or the like. Pod element 254 includes image processor 264 and display 266. Simplified live imaging UI and control functionality 268 is associated with pod element 254 and permits control of pod-based components/functions as well as probe-based components/functions. Probe element 252 and pod element 252 communicate through conventional means, e.g., USB, PCIe or the like. The Ul/control functionality 268 is communicated to and received by the pod-based components/functionalities through inter modular communication, e.g., internal wiring, PCB traces or the like, and Ul/control functionality 268 is communicated to and received by the probe-based components/functionalities by conventional means, e.g., USB, PCIe or the like.

As with CSD 200 described above with reference to Figure 5, pod element 254 is adapted for communication with companion application 280, e.g., through USB, PCIe or other communication means. Companion application 280 includes/supports various functionalities, e.g., patient management and post-imaging applications. Thus, companion application 280 may include/support patient management/post-imaging applications may include patient data, measurements, image annotation, image quantification, DICOM connectivity and the like. Of note, CSD 250 is particularly adapted to use in stand alone mode, in the same manner and with the same benefits described with reference to CSD 200 above. As noted herein, companion application 230, 280 may include/support various functionalities. Thus, for example, companion application 230, 280 may include/support basic CSD setup and image management. Alternatively, companion application 230, 280 may include/support additional functionalities, e.g., patient data management, basic measurements, and/or DICOM printing and archiving. Still further, companion application 230, 280 may include/support still further functionalities, e.g., advanced image postprocessing and quantification algorithms. Additional features and functionalities may be incorporated into companion application 230, 280 without departing from the present disclosure, as will be readily apparent to persons of skill in the art. Companion application 230, 280 may include and/or interact with an image control system, e.g., a web-based application and/or a conventional image management software to retrieve and manage JPG images from the disclosed CSD device/system (e.g., Windows Media manager available from Microsoft Corporation; Redmond, WA).

To further illustrate exemplary configurations/assemblies and methods that may be employed according to the present application, reference is made to Figures 7-12. Of note, the present disclosure is not limited by or to the configurations/assemblies or methods set forth in such figures.

Figure 7 schematically depicts exemplary probe device configurations according to the present disclosure. Probe element configuration 1 depicts an implementation where communication between the initial beamformer functionality and the final beamformer functionality takes place over a thin transducer cable (e.g., with 70 conductors), whereas probe element configuration 2 depicts an implementation where communications internal to the probe element are all achieved through inter modular communication means. Configuration 1 is typically assembled into two housings connected by a thin transducer cable, whereas configuration 2 combines all the components into one compact housing, thereby permitting elimination of the transducer cable.

Figure 8 schematically depicts exemplary pod device configurations according to the present disclosure. Pod configuration 1 depicts an implementation where communication to an external host takes place between the image processor and the host, whereas in pod configuration 2 such communication takes place between the UIVcontrol functionality and the host. Thus, the pod of configuration 1 typically contains a very limited UI and processing capability which limits the UI to selection of user presets defined by a host component. Configuration 2 generally contains a more complete scanning UI and expanded processing capability to support more scanning conditions.

Figure 9 schematically depicts alternative probe-pod combinations. Figure 10 schematically depicts four exemplary host types, according to the present disclosure. There disclosed host configurations include: (i) a conventional ultrasound system (cart based or compact) with a CSD management/synchronization application, (ii) a PC with live ultrasound imaging application and a CSD management/synchronization application, (iii) a PC with a full features image analysis application and CSD management/synchronization application, and (iv) a PC with a light CSD management/synchronization application.

Figures 11-14 schematically depict exemplary combinations of the disclosed components to provide the four exemplary use modes: (i) CSD/Host companion scanning mode (Figure 11); (ii) CSD scan-alone mode (limited UI with Pod configuration 1) (Figure 12); (iii) CSD/Host companion scanning and data transfer/synchronization mode (Figure 13), and (iv) CSD/Host data transfer/synchronization mode (Figure 14).

A display controller, e.g., a field programmable gate array (FPGA), in the pod element typically complements an acquisition controller, also typically an FPGA , in the probe element. The probe element also contains associated front end analog processing circuitry for transmission and reception of imaging signals through the transducer attached to or incorporated in the probe element. The display controller provides a high-speed link to the probe element via, for example, a PCIe interface on an ExpressCard interface. In exemplary embodiments, the pod element also contains an internal processor which runs a simple, embedded real-time OS. The display controller FPGA may instantiate the internal processor, which executes instructions from a program stored in the pod element's memory. The program and/or real-time OS typically reads the UI controls, performs scan conversions on data obtained from the probe element, and renders a near real-time image on the display.

In further exemplary embodiments, the program and/or OS operates to pass data from the probe element to the ultra wideband (UWB) chipset for wireless transmission to a host system. Exemplary embodiments where the display controller is an FPGA offer the most flexibility to interface "natively" with media access control (MAC) components of some UWB chipsets. An ultra-wideband transceiver chipset and antenna(s) connect directly to the display controller and may advantageously provide a wireless link to a host system.

A USB microcontroller, i.e., a small, self-contained embedded processor with an integrated USB Serial Interface Engine (SIE) and PHY, is preferably contained within the pod element. Alternatively, the USB SIE and PHY may be integrated into the display controller FPGA to form the USB controller, or they may be integrated into the aforementioned internal processor within the pod element. In any of these implementations, the USB controller may be used for connection to a host system. Thus, the USB controller in the pod element may be adapted to accept USB command data from a host system over a standard USB serial PHY, and convert it to parallel data to pass through a parallel port to its display controller. Similarly, imaging data generated by the probe element and optionally processed by the display controller goes back through the parallel port to the USB link when that link is active. In exemplary embodiments incorporating a USB microcontroller in the pod element, that microcontroller is responsible for initializing power management circuitry and configuring the display controller. In further exemplary embodiments, the USB microcontroller also controls all inter-IC (I2C) devices in both the probe and pod elements, such as a temperature sensor, battery gauge, and keypad.

The pod element typically communicates with the probe element by means of a pair of interfaces, i.e., PCIe and I2C interfaces. The PCIe interface generally connects an acquisition controller to a display controller. Control commands and acquisition configuration and coefficient data (coming through a USB port or through UWB communications into the pod element) pass through the display controller to the acquisition controller over the PCIe interface. In addition to the acquisition controller FPGA, the probe element preferably contains a separate USB microcontroller dedicated to the acquisition function. This USB microcontroller is capable of performing dedicated functions related to image acquisition, such as monitoring temperature and power supply voltages in the probe element via devices on the local I2C bus, configuring the acquisition controller FPGA, providing digital clock signals to the acquisition function, etc. The USB interface in the probe element may be used for direct communication with the host system, bypassing the pod element, allowing it to operate as an imaging peripheral in conjunction with the host system's USB port, image processing and display software. In this configuration the USB microcontroller in the probe element performs its dedicated functions. When the probe element is connected to the pod element, the USB microcontroller in the probe element is idled as described below.

In an exemplary embodiment, the I2C interface connects the pod element's USB microcontroller to an I2C device chain in the probe element, allowing the pod element USB microcontroller to replace the functionality of a USB microcontroller contained in the probe element. (Only one microcontroller can master the I2C bus at a time.) Thus, when the probe element is connected to the pod element, the probe element's USB microcontroller detects the connection and releases the I2C bus, enables the PCIe interface between the probe element and the pod element, and enters a low power operational state. The probe element's USB microcontroller generally does little more than generate an acquisition clock for the acquisition controller when in a low power operational state. In exemplary embodiments, the I2C bus between the probe element and the pod element is connected using ExpressCard SMBUS pins. When the probe element is used in a host system direct connection (other than to the pod element), these SMBUS pins are typically ignored or switched off using an analog switch on the probe element.

The USB microcontroller in the pod element offers several useful functions. For example, the USB microcontroller in the pod element functions with the USB microcontroller in the probe element to (i) guarantee a minimum power state of the pod element's processor during configuration, (ii) allow control of a CSD by a host system over a USB connection even when no probe element is then-attached (e.g., for configuring presets or performing diagnostics, etc.), and (iii) allow connections to circuits in the pod element that may need to be active even when the display controller is not, e.g., power management components, LEDs and certain UI switches.

During companion mode, commands and imaging data generally pass through the USB/UWB to the display controller, which in turn controls the probe element via the PCIe interface. Acquisition controller coefficients may be calculated by an application program on the host system and sent to pod element at mode changes. Upon a trigger from the host system, the current set of coefficients is stored in the non-volatile memory of the pod elements for rapid access at a subsequent point in time as a preset. When the CSD is switched to scan-alone mode, the display controller takes over controlling the acquisition controller, using the same internal PCIe link. The acquisition controller coefficients are obtained from the non-volatile memory, and transferred en masse through the PCIe link when a preset is selected via the UI. The imaging data from imaging from the probe element comes back through the PCIe link to the display controller, where it is processed and rendered on the local display and/or stored in the memory.

In exemplary embodiments of the present disclosure, the pod element of a CSD is connected directly or indirectly to a probe element through a short, thin cable on one side and (optionally connected to) a host system (e.g., via a USB cable and/or UWB wireless link) on the other side. The connection between the probe element and the pod element may be made by means of the aforementioned ExpressCard, with the cable to probe element's transducer emanating from the outside end of the ExpressCard. The disclosed CSDs generally have two primary modes of operation: (i) scan-alone mode wherein the CSD possesses either limited or full functionality as a scan-alone imaging system, and (ii) companion mode wherein the CSD operates in conjunction with a host system.

The disclosed CSD is generally capable of 2D imaging in echo mode, color flow mode, pulsed wave (PW) mode, and continuous wave (CW) mode with a broad set of imaging controls while in companion mode. In scan-alone mode, the CSD may be configured to present a more limited feature set, especially with respect to the imaging controls available on the UI. In companion mode, the disclosed CSD is typically relegated to functioning as a peripheral acquisition subsystem for a full-featured imaging system, such as the iU22 or iE33 ultrasound systems available from Philips Medical Systems. Conversely, in scan-alone mode, the disclosed CSD generally operates as a pocketable, handheld scanner that generates and stores its own images for limited viewing/analysis on a small embedded screen and/or later transfer/analysis by a host system. In exemplary embodiments, the user can switch between scan-alone and companion modes by means of a control switch on the pod element or (automatically) by disconnecting the CSD from a host system and roaming (e.g., unplugging the USB and/or removing the device from within wireless range).

In companion mode, the disclosed CSD is generally connected via USB or UWB to a host ultrasound system, such as the Philips iE33 ultrasound systems. In such companion mode, the disclosed CSD operates as a wired or wireless probe for the host system. The USB or UWB connection communicates control and configuration from host to the CSD and communicates acquired imaging data from the CSD to the host. In exemplary embodiments (involving a USB connection to a host system), when the USB connection is broken (e.g., unavailable, out of reach, or manually disconnected), then the UWB connection to the host automatically takes over if available. In exemplary embodiments, the USB connector on the CSD is magnetic, allowing for sealing of the CSD and damage protection if the USB cable is accidentally, forcibly removed from the CSD. Such configurations also allow for a quick switch from wired to wireless operations.

During scan-alone operation, the disclosed CSD is completely independent of the host system, and generates a diagnostic image on its built-in display using preset imaging configurations previously programmed/set by the user. The user selects amongst the preset configurations using the CSD's built-in UI. In exemplary embodiments, a user may configure one or more desired presets by performing test scans using the CSD while connected to a host system (companion mode). The preset configurations may be adjusted using the CSD's UI, the host system's UI, or both. After parameters for particular presets are finalized, each preset is stored within non-volatile memory contained or to be contained within the pod element and labeled for later access. Once the CSD is disconnected from the host system (scan-alone mode), the pod element's UI is used to accesses the stored preset(s) from within the non-volatile memory. Critically, the pod element's UI is minimal, contrasting with the full UI of the companion host system. The pod element UI consists of, at the minimum, a means of selecting labeled presets. This may be implemented as simply as with a rocker switch and a small alphanumeric OLED display.

In exemplary embodiments, the stored presets may determine some or all of the appropriate imaging parameters including, but not limited to, mode, gain, depth, scale, and ROI selections. The pod element's UI may also be used to modify certain parameters within a selected preset prior to, during or after image capture. Exemplary parameters for modification include, but are not limited to, depth and ROI. In most embodiments, the pod element's UI provides control(s) for freeze and acquire functions for both scan-alone and companion modes. Of note, presets may be advantageously transferred from one pod element to another. In addition, if the non-volatile memory is located in the probe element, presets may be transferred from one probe element to another. Preset transferability is a highly beneficial feature because one user can transfer a desired/preserved imaging setup to another CSD, thereby facilitating efficient replication of available equipment, upgrade, repair and mobility. The preset transfers can be transferred in various ways, e.g., over

USB, over UWB, or by physically moving non-volatile memory media such as an SD card. Still further, the design and operation of the disclosed devices/systems permit standard presets, e.g., presets that may be available from a company website or from a customer's organization, to be efficiently and reliably distributed/transferred for use.

Companion mode operations according to the present disclosure can be further divided into two distinct operation modes: (i) light companion mode that includes image storage and export in industry standard formats (e.g., JPEG) as well as transfer of user presets, including patient lists, protocol and setup parameters; and (ii) full-featured companion mode that includes storage and export of rich data for viewing and analysis in an imaging application run on a host system (e.g., QLab product available from Philips Medical Systems) with additional capabilities/functionalities, e.g., post-freeze controls, annotation, measurements, quantification and/or export to a DICOM server.

With reference to Figure 15, an exemplary form factor for a compact scanning device 300 is depicted. An exemplary probe element 310 is connected to an exemplary pod element 320. The depicted pod element 320 includes a display element 322 and a user interface 324. With reference now to Figure 16, an exemplary mapping of ultrasound controls onto a UI for a compact scanning device is depicted. The exemplary UI is modeled after the center control section of a conventional TV remote and thus is well designed to be operated quickly and easily. The simplification of the UI is based, at least in part, on moving some of the more UI intensive tasks to a companion application run by a host system for concurrent processing or preprocessing via user presets Exemplary tasks for transfer to the companion application include, but are not limited to, patient data entry, annotation measurements, and set-up selections. The following is an exemplary description of controls: New Patient: This control brings up a patient list that was created off line and transferred to the device when it was docked. The multi-purpose control is used to select the desired patient name. If the patient is not on the list, a new patient ID can be selected based on the time and date.

Protocol Select/Activate: Protocols can greatly improve workflow while minimizing the necessary control interaction. One example is to have a protocol list, which is worked though annotating each image as it is acquired. The multi-purpose control is used to navigate and select the protocol and protocol step.

Color/Doppler mode select: This is a mode select which cycles the system through Color, Color + Doppler and back to 2D. Review: This control selects a review mode where a user can view stored images. The multi-purpose control is used to navigate through the available images. Gain +/-: This control adjusts the overall gain of the active data type. Depth/Zoom +/-: This control is used to adjust the scale of the image. Freeze: Freezes and un-freezes the image.

IScan: Activates the iScan feature for optimizing the image. The iScan feature automatically adjusts the 2D TGC/LGC and Color and Doppler controls for optimal imaging (available from Koninklijke Philips Electronics N.V.). Acquire: This control captures the frozen image or loop based on set-up or protocol step. An exemplary approach is to acquire a single image when frozen and a predetermined loop length when live.

Multi-purpose control: This control is modeled after the generic navigation and select tool found on many handheld devices, including cell phones and TV remotes. In alternative embodiments, the control could take several other forms, including a circular control similar to that found on iPod devices. The primary purpose for the multi-purpose control is navigation and selection (e.g., patient and protocol), although it can also be used to set, color box position, Doppler sample volume position, pan, focus, and to control other context-specific needs.

Although the present disclosure is described with reference to exemplary embodiments and implementations thereof, the present disclosure is not to be limited by or to such exemplary embodiments and/or implementations. Rather, the apparatus, systems, and methods of the present disclosure are susceptible to various modifications, variations and/or enhancements without departing from the spirit or scope of the present disclosure. Accordingly, the present disclosure expressly encompasses all such modifications, variations and enhancements within its scope.

Claims

1. A compact system for diagnostic imaging, comprising: at least one probe element, wherein said probe element includes means for obtaining imaging data; at least one acquisition controller for controlling parameters associated with obtaining and/or processing the imaging data; at least one means for transmitting the imaging data to one of: (i) a host system, and (ii) a pod element; at least one pod element, wherein said pod element includes: at least one means for receiving imaging data from a probe element; at least one processor in communication with memory; at least one display controller in communication with the at least one processor; a user interface for controlling operations related to the imaging data.

2. The compact system according to claim 1, wherein the at least one probe element's means for obtaining imaging data is a transducer array.

3. The compact system according to claim 1, wherein the at least one probe element's means for transmitting imaging data is an ExpressCard, and wherein the at least one pod element's means for accepting imaging data is an ExpressCard slot.

4. The compact system according to claim 1, wherein the at least one probe element's means for transmitting imaging data is a USB interface.

5. The compact system according to claim 1, wherein the at least one processor contains an operating system.

6. The compact system according to claim 1, wherein the memory is comprised of one of: (i) an SD card, (ii) a Flash memory, and (iii) an SD card and a Flash memory.

7. The compact system according to claim 1, wherein the user interface includes a limited number of dedicated controls.

8. The compact system according to claim 1, wherein the memory is used to store one or more user presets, and wherein the user interface can be used to access the one or more user presets.

9. The compact system according to claim 1, further comprising: one or more display elements; at least one power source at least one means for transmitting data to and from the at least one host system.

10. The compact system according to claim 9, wherein the at least one power source is one of (i) a battery, (ii) a USB connection, and (iii) a battery and USB connection.

11. The compact system according to claim 9, wherein the probe element's at least one means for transmitting data to and from the at least one host system includes at least one of: (i) a wireless transmitter, (ii) a USB connection, and (iii) a wireless transmitter and USB connection.

12. The compact system according to claim 1, further comprising a host system in communication with at least one of the probe element and the pod element.

13. The compact system according to claim 12, wherein the at least one probe element obtains imaging data from a subject, and wherein the at least one pod element one of (i) stores the imaging in the memory for later transmission to the host system, (ii) transmits the imaging data to the host system via the at least one probe element's at least one means for transmitting data to the host system.

14. The compact system according to claim 12, wherein the host system and the compact system may be selected to operate in one of (i) companion mode, and (ii) scan- alone mode.

15. The compact system according to claim 14, wherein the host system is used to configure and store user presets into the at least one pod element's memory when in companion mode.

16. The compact system according to claim 15, wherein the at least one pod element selects at least one user preset configuration from the at least one pod element's memory while in scan-alone mode.

17. The compact system according to claim 16, wherein the at least one user preset configuration may be transferred to the at least one pod element's memory of a 2^nd compact system using one of (i) a USB connection, (ii) a UWB connection, and (iii) physical transfer of a non-volatile memory.

18. The compact system according to claim 11, wherein the at least one host system is an ultrasound system.

19. The system for diagnostic imaging according to claim 11, wherein the at least one host system is a PC, and wherein the PC is adapted to run an imaging application.

20. A method for facilitating mobile diagnostic imaging, the method comprising the steps of: providing an apparatus that includes at least one probe element and at least one pod element; and acquiring imaging data using the apparatus.

21. The method according to claim 20, wherein the at least one probe element includes means for obtaining imaging data; at least one acquisition controller for controlling parameters associated with obtaining and/or processing the imaging data; and at least one means for transmitting the imaging data to one of: (i) at least one host system, and (ii) a pod element.

22. The method according to claim 20, wherein the at least one pod element includes: at least one means for receiving imaging data from a probe element; at least one processor in communication with memory; at least one display controller in communication with the at least one processor; a user interface for controlling operations related to the imaging data; one or more display elements for displaying the imaging data; and at least one power source for powering the foregoing components.

23. The method according to claim 20, further comprising transmitting data to and from at least one host system.

24. The method according to claim 20, wherein the at least one probe elements and the at least one pod elements are configured for a specific imaging application.

25. The method according to claim 20, wherein the at least one pod element's memory is comprised of at least one SD card, wherein the SD card is programmed to contain at least one user preset, and wherein each one of the at least one user preset is configured for one of (i) a specific application and (ii) a particular user.

26. The method according to claim 20, further comprising the step of viewing an image obtained from the acquired imaging data on one of (i) a display element associated with the at least one probe element, and (ii) a display element associated with a host system in communication with the apparatus.

27. The method according to claim 20, further comprising the step of configuring image acquisition settings using user presets prior to acquiring imaging data.